Application of Robert JOLY and Julien Warnant.
Patent Appeal No. 7472.
United States Court of Customs and Patent Appeals.
March 16, 1967.
Dissenting Opinions April 10, 1967.
376 F.2d 906 | 54 CCPA 1159
Smith and Rich, JJ., dissented.
Joseph Schimmel, Washington, D.C. (Jack E. Armore, Washington, D.C., of counsel), for the Commissioner of Patents.
Before WORLEY, Chief Judge, and RICH, SMITH, and ALMOND, Judges, and Judge WILLIAM H. KIRKPATRICK.*
ALMOND, Judge.
This is an appeal from the decision of the Board of Appeals affirming the rejection of product claims 1 to 3 and process claims 8 to 12 of appellants’ application serial No. 81,272, filed January 9, 1961, entitled “Esters of 2-Enols of Δ1 Steroids and Preparation Thereof.”
1. A compound having the formula
wherein X is selected from the group consisting of hydrogen and methyl, Y is selected from the group consisting of hydrogen and an acyloxy radical of a lower organic carboxylic acid having 1 to 7 carbon atoms and Y’ is an acyl radical of a lower organic carboxylic acid having 1 to 7 carbon atoms.
Composition of matter claims 2 and 3 are directed to specific compounds, 2,21-diacetoxy-Δ1-pregnene-17α-ol-3,11,20-trione and 2-acetoxy-16α-methyl-Δ1-pregnene-17α-ol-3,11,20-trione, respectively. Claims 8 to 12 are directed to a process for the manufacture of the claimed steroids, which appellants disclose in their specification to be “useful as intermediates” in the following terms:
The products obtained by the invention, the lower organic carboxylic acid esters of enols in the 2-position of Δ1-steroids, are particularly useful as intermediates in the preparation of steroids, especially steroids having a ketone group in the 2-position, such as 21-acetoxy-pregnane-17α-ol-2,3,11,20-tetraone and 16α-methyl-pregnane-17α-ol-2,3,11,20-tetraone by acid hydrolysis and customary separation steps.
The Board of Appeals rejected all claims for appellants’ failure to satisfy the requirements of
In their memorandum on reargument, appellants concede that, in view of Brenner v. Manson, the appealed process claims should not be found allowable unless we find the claimed compounds produced by that process to be “useful” under
The examiner finally rejected all claims for “insufficient disclosure of utility.” Analyzing the above disclosure in appellants’ specification, he stated:
* * * the applicants have stated only that the [claimed] final products may be converted to the corresponding 2-keto compounds, which compounds have no known utility. * * * [Emphasis supplied.]
The board agreed, adding:
The portions of the specification * * * show that the claimed compounds can be used to prepare the corresponding 2,3-keto compounds. Having arrived at that point, what has been accomplished? Appellants do not assert that the latter compounds have known utility * * *.
* * * such conversion does not constitute a disclosure of utility for the claimed compounds because there is no disclosed utility nor any indication of a known utility for the 2,3-keto derivatives. A useless product does not become useful by virtue of conversion into another useless product. [Emphasis supplied.]
Appellants do not contend that a use for the claimed compounds, other than as
We do not accept those arguments. There is no evidence of record that the particular 2,3-diketo steroids which can be obtained from the claim compounds possess properties or activities in common with the allegedly “closely related” compounds having known useful properties, cortisone and prednisone. Similar arguments were presented to, and rejected by, the Supreme Court in Brenner v. Manson, 383 U.S. at 531-532, 86 S.Ct. 1033, and this court in In re Kirk where we stated:
It cannot be presumed that a steroid chemical compound is “useful” under
§ 101 , or that one of skill in the art will know “how to use” it, simply because the compound is closely related only in a structural sense to other steroid compounds known to be useful. * * *
Nor do we agree that the mere disclosure that a claimed chemical compound may be used as an intermediate to make other compounds, without regard for the usefulness of the latter compounds, is adequate under
* * * the conclusion is inescapable that, just as the practical utility of the compound produced by a chemical process “is an essential element” in establishing patentability of the process, [Brenner v. Manson] 383 U.S. 519, [86 S.Ct. 1033,] so the practical utility of the compound, or compounds, produced from a chemical “intermediate,” the “starting material” in such a process, is an essential element in establishing patentability of that intermediate. It seems clear that, if a process for producing a product of only conjectural use is not itself “useful” within
§ 101 , it cannot be said that the starting materials for such a process—i. e., the presently claimed intermediates—are “useful.” It is not enough that the specification disclose that the intermediate exists and that it “works,” reacts, or can be used to produce some intended product of no known use. Nor is it enough that the product disclosed to be obtained from the intermediate belongs to some class of compounds which now is, or in the future might be, the subject of research to determine some specific use. * * *
Appellants argue here that the particular 2,3-diketo steroid which is prepared from the compound of claim 2 can itself be used to prepare a compound of “recognized therapeutic activity,” A-nor cortisone. They rely on certain documentary material in their brief, not part of the evidence before the Patent Office, to support the proposition that A-nor cortisone, known to be useful at the time of filing their application, can be prepared from the claimed compounds. We have not considered that “evidence.” See In re Cofer, 354 F.2d 664, 53 CCPA 830.
The decision is affirmed.
Affirmed.
RICH, Judge.
Notice of Forthcoming Dissenting Opinion
I, like Judge Smith, whose sentiments I share, am now revising a dissenting opinion to cover this case and the companion Kirk case (376 F.2d 936, 54 C.C.P.A. —), argued together December 5, 1966, and involving similar issues. I initially filed my tenative dissenting opinion in Kirk February 1 in response to a December 22 majority opinion therein and a January 24 opinion herein. Thereafter the majority opinion herein was 75% rewritten on February 8 and again, on February 20, its content, responsive in part to observations in my dissent, was reduced 50%. In the ensuing three weeks the court has conferred on a long agenda of cases and held a week of hearings March 6-10, upon the conclusion of which I resumed, on March 13, my revision of the dissent. On that day notice was given by the Chief Judge that these two cases “will go down Thursday, March 16.”
Protest to the arbitrary use of assumed power having proved futile, this unprecedented display of unseemly haste, condoned by the majority, necessitates this notice.
SMITH, Judge (dissenting).
Our usual practice is to release the majority opinion simultaneously with any dissenting opinions. There has been an unwarranted departure from this procedure in this case, the effect of which is to preclude an expression of my views at this time. I am unable to see wherein the cause of justice is served by such an irregular procedure. This dissent is therefore 1) a protest to the procedure here adopted, and 2) a notice that my full written dissent will be forthcoming as soon as the pressures of court work permit.
WORLEY, Chief Judge (specially concurring).
It is most regrettable that for the first time in the history of this court, the usual orderly processes of the court have been ignored by a minority.
The instant appeal was re-argued December 5, 1966. The majority opinion was circulated February 20 in its present form. Yet, now, nearly one month later, the dissenting opinions are not available and no valid excuse is given.
It would seem that if the majority can direct its time and attention to expediting the work of the court it should not be too much to expect the same diligence from the minority.
It should not be necessary to say that the duty of this court is to the litigants, applicants for patents, the Patent Office and the public—not to the possible whims and caprices of individual judges. It is impossible to discharge that duty by condoning the instant derelictions, which hereafter will not be countenanced.
RICH, Judge.
Notice of Withdrawal
With the filing of the attached dissenting opinion in the above case, I hereby withdraw my “Notice of Forthcoming Dissenting Opinion,” dated March 16, 1967 (published in Patent, Trademark and Copyright Weekly Reports for April 3, 1967, 153 USPQ No. 1, at page 47 following the majority opinion herein).
RICH, Judge (dissenting).
I am in general agreement with the views of Judge Smith as stated in his dissenting opinion herein but I have more particularly stated my views in my dissenting opinion in the companion case of In re Kirk, 376 F.2d 936, 54 CCPA —.
Notice of Withdrawal
The attached dissenting opinion shall be substituted for my previous dissenting opinion filed March 16, 1967.
SMITH, Judge (dissenting).
Introduction
Many of the observations made by Judge Rich in his dissenting opinion in In re Kirk et al. 376 F.2d 936, 54 C.C.P.A. —, (hereinafter Kirk) concurrently released, have particular pertinency here. I am in general agreement with the principles there stated. The majority in the present case rests its opinion on the decision in Kirk. Therefore, those portions of the dissents of Judge Rich and myself in Kirk which are directly applicable here are incorporated by reference, thus avoiding their needless repetition in this opinion. Here, as in Kirk, the majority accepts without question, applies, and extends the dictum in Brenner v. Manson, 383 U.S. 519, 86 S.Ct. 1033, (hereinafter Manson) with shocking disregard of the total effect of its decision on patents relating to inventions in the chemical field.
Therefore, I propose to demonstrate in this dissent how the majority opinion changes the intent and meaning of the Patent Act of 1952, and how it amounts to no less than usurpation of the authority exclusively granted to Congress by
Basically, my disagreement with the majority opinion is predicated on three grounds: (1) It is not supported by the facts of record, (2) It so misconstrues, misapprehends and misapplies the decision of the Supreme Court in Manson as to create a direct constitutional conflict, and (3) It deprives appellants of property without due process of law in abrogation of the
The majority‘s error lies in accepting, apparently without question, what actually is dictum in the Manson opinion and in disregarding the decisional law therein. In this case the error arises because the majority ignores certain critical facts of record which were not present in Manson. By adopting the qualifying adjectives found in the Manson dictum, while ignoring the factual basis upon which this case arises, the effect of the majority opinion is to qualify the meaning of the term “useful” in
The drastic and far reaching amendment of the statute which results from the majority decision here and in Kirk should be the sole responsibility of Congress after due investigation and proper weighing of its effect upon the economy of the United States. Such action is not the proper function of this court.
Judge Rich, in his Kirk dissent, has pointed out that the historical policy and interpretation of the patent law, prior to the time of the Bremner decision, is contrary to the position of the majority in Kirk. For many of the same reasons, this historical policy is contrary to the majority position herein.
Cohen and Schwartz in an article entitled “Do Chemical Intermediates Have Patentable Utility?” 43 JPOS 479 (1961), discuss the history of the so-called “utility requirement” as we are to consider it in the present context. They state:
Prior to In re Bremner the Patent Office considered that any organic
compound could be useful as an intermediate under the rule of Ex parte Watt [63 U.S.P.Q. 163]. However, after Bremner, which required that the intended uses be set forth in the specification, the Patent Office departed from its former practice regarding the disclosure necessary to support patentability of chemical compounds. As indicated in the amicus curiae brief of the American Patent Law Association in Nelson: Rejections for “lack of utility” now engage much of the time of the Patent Office and practitioners in the chemical field whereas, until about five years ago, practically no time was spent by either of these groups on utility-disclosure questions. In this new scrutiny of utility to judge its sufficiency, degrees or levels of utility are being distinguished to differentiate what is “practical” from what is not, and applications not meeting a criterion for “practical” utility established by the Patent Office are being rejected. The rejections are based not only on alleged failure to describe exactly what “practical” or end use a new chemical compound has, but also on lack of disclosure of a specific embodiment of such end use. * * *
In short, the action of the Patent Office in holding that there is no disclosure of utility without disclosure of an end use of the invention, often in detail unnecessary for those skilled in the art, is seriously impeding the development of the useful arts. This is believed to be contrary to the preeminent purpose of the patent system, which is to promote the progress of the useful arts. [Emphasis added.]
In their “Conclusion,” Cohen and Schwartz state:
Since the Bremner decision fostered a too rigorous interpretation of the utility and how-to-use requirements, it was inevitable that an appropriate appellate court would rectify the situation. The Nelson decision should reverse the trend initiated by Bremner and tenaciously adhered to by the Patent Office for the last ten years. * * *
The authors further state:
It is believed that the rule of law announced in the Nelson opinion is sound. Although the liberal Nelson decision might even be termed radical when viewed in the light of Patent Office practice for the past ten years, it finds support in the language of the Bremner decision and the Patent Statute.
Mr. Justice Harlan‘s dissenting opinion in Manson correctly reviews the history of the utility requirement in chemical cases and points out the factually insupportable position there apparently taken in the majority dictum. His statement is equally pertinent here. As Mr. Justice Harlan states:
* * * In my view, our awareness in this age of the importance of achieving and publicizing basic research should lead this Court to resolve uncertainties in its favor and uphold the respondent‘s position in this case.
This position is strengthened, I think, by what appears to have been the practice of the Patent Office during most of this century. While available proof is not conclusive, the commentators seem to be in agreement that until Application of Bremner, 182 F.2d 216, 37 CCPA 1032, in 1950, chemical patent applications were commonly granted although no resulting end use was stated or the statement was in extremely broad terms. Taking this to be true, Bremner represented a deviation from established practice which the CCPA has now sought to remedy in part only to find that the Patent Office does not want to return to the beaten track. If usefulness was typically regarded as inherent during a long and prolific period of chemical research and development in this country, surely this is added reason why the Court‘s result should not be adopted until Congress expressly mandates it, presumably on the basis of empirical data
which this Court does not possess. [Citation omitted.]
I agree with Mr. Justice Harlan‘s views. The position taken here by the majority and the Patent Office in view of the facts of record serves as a warning as to the “path” and direction chemical practice is being forced to take.
The Majority Here is not Supported by the Facts of Record
Candor requires that the carefully expurgated statement of facts appearing in the majority opinion be enlarged to the end that a fair presentation may be made of all the pertinent facts which bear on the issues before us. Initially, however, the inventions and the basis for the rejection may be summarized in simplified form.2
The claims cover what are admittedly novel and unobvious processes (claims 8–12) and products (claims 1–3). The claimed processes and products may be represented in the following diagram by numerals and letters, respectively:
Appellants start with compounds A. Claims 8–12 are drawn to the two-step process 1–2, in which compounds A are converted to compounds B and compounds B are then converted to the products C which are claimed in appealed claims 1–3. Appellants specifically disclose in their specification that products C can be converted to products D by process 3. However, neither products D nor process 3 is claimed and thus they are not in issue here. No question has been raised as to the operability of any of the processes or as to the adequacy of the description and identification of any of the products.
The examiner‘s answer broadly stated the ground of rejection as to all claims as follows:
* * * It is the Examiner‘s position that the instant specification fails to present a disclosure of utility sufficient to satisfy the requirements of
35 U.S.C. 112 . * * * [Emphasis added.]
No further statement was made by the examiner concerning the invention defined by process claims 8–12. As to the claimed products (claims 1–3) the examiner stated:
* * * The fact is not controverted that the applicants have shown a method of converting [process 3] the claimed compounds [C] into another compound [D]; however, it is maintained that the final product [D] has not been shown to possess any specific utility that would be readily apparent to those skilled in the art. It is obvious that most compounds can be converted or modified in some manner; however, such a conversion [process 3] is not deemed to be a basis upon which an applicant may base an assumption of utility and thus satisfy the requirements of
section 112 of the Code. * * * [Emphasis added.]
No other statute was cited by the examiner. Indulging the presumption that he was aware of the requirements of
The Board of Appeals clearly felt the examiner‘s sole reliance on
When this new ground of rejection was brought to the board‘s attention by appellants’ petition for reconsideration, the board‘s response was:
In the first paragraph on page 3, appellants suggest that we made a new ground of rejection in referring to
35 U.S.C. 101 , as well as35 U.S.C. 112 . We do not agree that a new rejection is made by referring to the fundamental patent statute which defines patentable subject matter.
I simply cannot square such “star chamber” procedures, and the majority‘s ready acceptance of them, with the basic requirements of the
However, in addition, under what principles does this court purport to operate in granting or denying remands when a new ground of rejection is made? Less than two months ago a majority of this court quoted with approval, in In re Wiechert, 54 CCPA —, 370 F.2d 927, the following from In re Hughes, supra:
It seems basic to the concept of procedural due process that an applicant at least be informed of the broad statutory basis for rejecting his claims, so that he may determine what the issues are on which he can or should produce evidence.
In Wiechert a majority remanded so that the appellant there could have the opportunity to present facts as to the unobviousness of the claimed invention because the board sua sponte advanced a totally new theory of obviousness. Here the board forces the appellant to rely on arguments and evidence directed to “how to use” their claimed inventions,
Returning now to the board‘s decision concerning the claimed products, it was of the view that:
* * * such conversion [process 3] does not constitute a disclosure of utility [§ 101] for the claimed compounds because there is no disclosed utility nor any indication of a known utility for the 2,3-keto derivative [D]. A useless product [C] does not become useful by virtue of conversion into another useless product [D]. [Emphasis added.]
As to the process claims, the board‘s opinion states:
* * * a process [processes 1–2] which does not result in the production of a useful product [compounds C] cannot be held to satisfy the utility requirement of
35 U.S.C. 101 and112 , no matter how complete the disclosure of how to carry out the process. * * *
It is readily apparent that both the examiner and the board were of the opinion that
It is at once apparent that the examiner and the board were not concerned with the usefulness of the claimed inventions; rather, they were concerned with whether compounds made from the claimed inventions were useful and with requiring a disclosure as to how these further compounds may be used.
Any fair and informed reading of
However, the board opinion, aided by its question-begging, a priori designation of the unclaimed compounds as “useless,” must be further examined in light of the Supreme Court‘s decision in Manson. Assuming that the statutes do not require that appellants disclose “uses” for or disclosures of “how to use” unclaimed products eventually resulting from their claimed inventions, is there something outside the statutes which requires such a disclosure?
The board said “yes,” based on its unsupported assumption and irrelevant observation that one of ordinary skill in the art would know nothing concerning compounds D. Therefore, so reasons the board and the majority here, compounds C and processes 1–2 must be “useless.”4 This, however, does not change the fact that there is not here, nor was there in Manson, the slightest factual basis for such a characterization of either the claimed products or the claimed processes.
Judge Rich in his Kirk dissent demonstrates that chemists of ordinary skill in the art would have no difficulty in using new and unobvious chemical products and processes once they are disclosed as required by
In this connection, it is interesting to note a recent advertisement of The Eastman Kodak Company which appeared on page 133 of the New Yorker Magazine for March 25, 1967. It describes in part the activities of what are termed “Two executives in charge of eagerness.” The advertisement points out that the Eastman line consists of “some 5,000 organic chemicals for laboratory use.” The text then continues:
* * * the fewer the starting materials, the more laborious the work. The more compounds that can be purchased from us, the more time our learned customers can put on research instead of preparing for research. * * *
As further pointed out in this advertisement, “Availability governs feasibility for many a research idea in its fetal stages.”
The examiner‘s position clearly was that the specification failed to meet the requirements of
What, indeed, is the meaning of “useful?” We are dealing with a word which we have been admonished in Manson is “pregnant with ambiguity.” My understanding of the law is that the “useful” inventions encompassed by
The constitutional provision as interpreted by Mr. Justice Douglas in his concurring opinion in Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 71 S.Ct. 127, 95 L.Ed. 162, outlines a test which, if applied to the facts here, requires a reversal of the board‘s decision. His opinion states:
* * * The invention, to justify a patent, had to serve the ends of science—to push back the frontiers of chemistry, physics, and the like; to make a distinctive contribution to scientific knowledge. * * * Patents serve a higher end—the advancement of science. An invention need not be as startling as an atomic bomb to be patentable. But it has to be of such quality and distinction that masters [persons of ordinary skill] of the scientific field in which it falls will recognize it as an advance. * * * [Citations omitted.]
Justice Douglas’ observation, while directed to the old requirement for “invention” which Congress subsequently replaced by the
I immediately think of the many things I personally do not know how to “use,” e. g., the “2-methyl dihydrotestosterone derivatives” in Manson. The obvious inquiry is how are we to judge what is “useful.”
The Supreme Court in the Manson dictum advances as one test that judges look to the “objects” of the invention in determining what the invention is useful for. Yet in the same opinion we are told that “objects of scientific inquiry” are, as a matter of law, not “useful.” Thus, allegedly because of Manson, the majority here and in Kirk find that we are dealing with “objects of scientific inquiry” which, under the Manson dictum, are not “useful” as a matter of law.
Manson also advances as tests that judges look for “practical,” “substantial,” and “specific” utility in “currently” available form, thus apparently requiring a search or quest for some quantum of utility which an unidentified segment of society will enjoy in the present, apparently overlooking the segment which would actually use the invention or its products.
Mr. Justice Story‘s test, “beneficial use to society,” is rejected in Manson as shedding “little light on our subject.”
However, it is somewhat confusing to consider that under Manson, products which inhibit the growth of tumors in laboratory animals are, as a matter of law, considered “useful,” i. e., they possess the necessary quantum and type of utility. See in Manson footnote 17 listing decisions of this court which are not overruled here by the majority. See also In re Folkers, 344 F.2d 970, 52 CCPA 1269, discussed by Judge Rich in Kirk.
What is the basis for drawing such a line of distinction? Wherein lies the “practical,” “substantial” and “specific” utility of chemical products which inhibit the growth of tumors in rats and what is the then specific benefit to the public in currently available form? At this point in time, such products and rats are in one sense no more than “objects of scientific inquiry,” lacking a “specific benefit in currently available form,” and as such, under the Manson dictum taken broadly are not legally “useful.” However, the finding of usefulness of such products was not disturbed by Manson or the majority here. Hopefully subsequent experiments will show that these products are similarly useful in hurnans at a later date. They have a “[potential] beneficial use” to society, see Mr. Justice Story, Gelston v. Hoyt, 3 Wheat 246, 302, 304, 308, 16 U.S. 246, 302, 304, 308, 4 L.Ed. 381 (1818) (Appendix), and as they qualify under Manson they are thus legally “useful.” It is indeed confusing, in attempting to judge what is “useful,” to consider that “beneficial use” to society is insufficient usefulness under Manson but that a “potential beneficial use” may be sufficient. Similarly, in judging what is useful, a potential future use to society apparently qualifies as a “specific benefit in currently available form.”
In view of the constitutional reference to “science” and the “useful arts” and the Manson dictum, how are we as judges to determine what is “useful?” Mr. Justice Story‘s test stands rejected. Instead of determining whether there is a “beneficial” use to society, are we to determine whether there is a “substantial,” “practical,” and “specific” use, presumably to society? It does not seem that the substitution of the Manson adjectives for Justice Story‘s adjective “beneficial” provides meaningful assistance in determining when an invention is useful.
Mr. Justice Story, in an attempt to define what class of inventions were useful, intimated that inventions which are “frivolous and insignificant,” are not “useful” and thus not patentable. But we are warned in Manson that this is, in one sense, “a query no easier of application than the one built into the statute.” Is it the intent of the Manson dictum to define generally and in the abstract those classes of inventions which are to be considered useful, under
Does the majority here attempt to construe or interpret Manson so as to set forth some meaningful standard or test by which we and the Patent Office may judge what is “useful?” The answer is “No.” The majority but repeats the qualifying adjectives of Manson, interprets “objects of scientific inquiry” broadly, and concludes that the inventions here claimed are “useless.”
Under the majority decision here, and its extension of the dictum in Manson, an inventor, contrary to the law as it has existed since 1790, is not entitled to a patent in the chemical field until he can assert and prove that it has a “practical,” “substantial” and “specific” usefulness which confers a “specific benefit” which must exist in “currently available form.”
It is fortunate indeed that such a view did not prevail in the past. Under such a test I seriously doubt whether the present majority would find the first powered flight of the Wright Brothers to be “useful.” Since it lasted but 12 seconds, traversed but 120 feet, and reached a maximum height of but 10 feet, it cannot be said to have had a “practical” or “substantial” utility or that it made powered flight practical or substantial in a then “currently available form.” Under the majority view such a flight would indeed be “useless.” For that matter, Morse‘s first attempts at electric telegraphy, Bell‘s first telephone, Hall‘s first production of aluminum, Edison‘s first incandescent lamp and a host of other pioneering inventions did not possess any “practical” or “substantial” utility nor did they yield a specific benefit “in currently available form” until many years after the first primitive tests. By the tests of the majority here all are seemingly “useless” and hence unpatentable. But history shows the usefulness of these inventions was found sufficient for patentability.
The erroneous reasoning of the majority is not new to those who have considered the historical antecedents for the Patent Office position. Rather, such reasoning is to be expected. It may be illustrated, I think, by what has been reliably reported as having been an official action in the application of Marriott, Ser. No 44,822, filed Oct. 31, 1881, for a heavier-than-air device for aerial navigation. Despite supporting affidavits as to operability of the device, the examiner rejected the application for a patent, insisting that “It is the opinion of the examiner that an apparatus for navigating the air which does not depend upon a gas field for the elevating means, is an impractical structure.” He suggested an amendment whereby structure defining a closed chamber for a lighter-than-air gas, e. g., a balloon, be added which, in his view, would render the apparatus “practical.” Similarly, the test which the majority here writes into
Before summarily discarding the long-standing interpretation placed on
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It seems to me that a chemist would have no difficulty in understanding the usefulness of “unusual surface active properties” or visualizing the compound as a tool to introduce “crosslinking sites.” Thus I would find that the compound offers a specific benefit in currently available form and is useful in view of any meaningful interpretation given to Manson. I doubt if any of these “suggested uses” would be legally “useful” in the view here expounded by the majority.
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The chemist is told he can hook a fatty acid, cross-link a polymer, bind a dye, tie up an odor or sequester an irritant. The usefulness of such a versatile tool would surely be understood by a chemist. The chemist who uses this tool may be concerned with the usefulness of his end product or have some objective in mind but the inventor of the tool should not have to be concerned with these considerations. The majority here, however, says he must. Further, are any of these suggestions the disclosure of a legally “useful” product within the rule here applied by the majority?
Another consideration which demands a careful evaluation of the majority‘s view here arises from the currently vast expenditures of public funds in support of research. The public press almost daily contains reports of such research programs. The following report was taken from the Washington Post, February 15, 1965.
Molecule Built As Virus Fighter
National Science Foundation drawings
This is the familiar benzene ring, made up of hydrogen and carbon atoms.
This is cubane, a box-like chemical structure recently synthesized in the laboratory.
The new molecule is called cubane to describe its box-like structure. As far as chemists know, cubane does not exist in nature.
A description of cubane, long sought after by chemists, was given yesterday in the annual report of the National Science Foundation, which financially supported its development by theoretical chemist Phillip E. Eaton.
Cubane is a hydrocarbon, a member of that vast family of hydrogen and carbon molecules such as propane, benzene and naphthalene that play an important role in science and industry. But what distinguished cubane from all other known hydrocarbons is its unique-geometry. Essentially, cubane has a box-like or cage structure with a hole or cavity for a center.
Derivatives Sought
Eaton, who is interested primarily in the theoretical aspects of his new molecule, explained yesterday that he now is tinkering with the molecule to produce cubane derivatives. This means substituting certain atoms such as iodine and bromine for hydrogen atoms or groups of atoms such as amines for hydrogen atoms.
Ever since its creation last year, which took Eaton nine months, cubane has been eagerly sought by theoretical and practical chemists alike. So much so, Eaton suggested, that he is having difficulty meeting the demand.
Because cubane bears certain relationships to other molecules with biological significance, at least two chemical companies want to test cubane compounds as anti-viral drugs. Other researchers think cubane-derivatives have promise as pesticides. But Eaton said it is still too early to predict what specific application cubane compounds will have.
President Urges Support
The synthesis of cubane, which has attracted worldwide attention, is one of several Government-sponsored research achievements cited by the Foundation in its annual report to the Congress.
Yesterday, in a message accompanying the report, President Johnson encouraged Congress to maintain its “support of what is required to assure America‘s continuing leadership in the science and technology of our times.”
At the same time, the report served to acquaint Congressmen with the views of Leland J. Haworth, who a year ago became director of the Foundation, which is the Federal patron saint of scientific research and education.
In a lengthy statement, Haworth set forth some of his ideas for meeting challenges that face Government support of science in general and the Foundation in particular. Hence, Haworth noted that the Foundation “is actively seeking” new administrative devices to provide researchers with longer-term support than has hitherto been possible.
Centers of Excellence
Haworth also suggested that the phrase “centers of excellence” be more precisely defined to mean not just an entire institution, but a department or school within an institution.
And finally, with a nod to the increasing interaction of science and politics, Haworth said:
“It is clear that determination of appropriate levels of support by fields of science is a problem that will continue to require judgments which take into account policies, attitudes, and political realities—none of which can be treated quantitatively. These may, in a good many cases, turn out to be the most important elements in setting priorities.” For the immediate future, therefore, Haworth concluded, the Foundation has no choice but to con-
sider these elements in making its decisions. [Emphasis added.]
As I understand the thrust of the majority opinion as it interprets the Manson dictum, new chemical products such as those envisioned in the above article are not legally “useful” and hence not patentable. Thus the Federal Government which has financed the development of such products through the National Science Foundation may not be protected for the molecule disclosed has no “presently available,” “substantial” use, hence in the legal sense is “useless” and thus does not meet the requirements of
The substance of the above article should be of great concern to all interested in a sound patent system. Mr. Eaton gave something to science which was long sought after. He is having difficulty in meeting the demand. His discovery has attracted the attention of the President, Congress and the world. Only suggested uses are known. But President Johnson * * * encouraged Congress to maintain its “support of what is required to assure America‘s continuing leadership in the science and technology of our times.”
It seems to me that the majority does a great disservice, which will have untold repercussions, by misapplying and misconstruing Manson. What purpose is served by placing the Supreme Court in conflict with both the reality of research and national goals by elevating dictum and portraying the Supreme Court in a ridiculous posture through misconstruction?
It may be that Mr. Eaton‘s discovery “may engross a vast, unknown, and perhaps unknowable area,” Manson. However, this is the case in all major breakthroughs. And the possible uses of an invention should not be confused with the invention.
I fear for the inventor and science in general in view of the majority opinion. Unless Manson is reconsidered or further clarified by the Supreme Court, or unless Congress takes note, Mr. Eaton and his colleagues, as well as this country, will suffer a devastating loss.
For some 177 years the broad dissemination of knowledge was encouraged by the Constitution, the patent laws, and uniform judicial decisions which placed a liberal interpretation on the term “useful” as it now appears in
Appellants have disclosed a simple and advantageous process of placing a chemical substituent on a steroid and the majority asks, erroneously in my view, what do you do with the resulting compound, etc.? Considering the TAM Zirconium compounds, supra, the majority would apparently label them as “useless” until someone explained what you did with the compound after you hooked a fatty acid, etc.
Before rendering opinions having the sweep and scope of the majority opinions here and in Kirk, we should first look to those of ordinary skill in the art to which the invention pertains and judge its “usefulness” on this basis. Otherwise, the result will be that envisioned by Mr. Justice Harlan in his dissenting opinion in Manson where he stated:
* * * The thought that these inventions may be more likely than most to be disclosed even if patents are not allowed may have more force; but while empirical study of the industry might reveal that chemical researchers would behave in this fashion, the abstractly logical choice for them seems to me to maintain secrecy until a product use can be discovered. * * *
What I find most troubling about the result reached by the Court is the impact it may have on chemical research. Chemistry is a highly interrelated field and a tangible benefit for society may be the outcome of a number of different discoveries, one discovery building upon the next. To encourage one chemist or research facility to invent and disseminate new processes and products may be vital to progress, although the product or process be without “utility” as the Court defines the term, because that discovery permits someone else to take a further but perhaps less difficult step leading to a commercially useful item.
The facts recently before us in Huang v. Cheney, 362 F.2d 816, 53 CCPA 1355, provide some needed perspective on the public policy aspects of the problem created by the majority opinions here and in Kirk. This was an interference and no issue of patentability was before us. There one Bachelor published a paper disclosing how to obtain, by a process of microbial fermentation, a supply of 6-APA, 6-Aminopenicillanic acid. Applying the Manson dictum, as interpreted by the majority, to Bachelor‘s invention requires the conclusion that since 6-APA per se at this stage had no “practical,” “substantial” utility, ergo it was “useless,” his new process also was “useless.” However, since it was apparent to both Huang and Cheney that 6-APA was a product which might lead to interesting new penicillins, they were immediately spurred into action when they knew of its existence and they began their experiments for modifying 6-APA. Starting with the 6-APA product, both Huang and Cheney subsequently invented in a few months the same “end” product which was shown to have therapeutic properties. The contest in this court was to determine which party was the first inventor of the end product. It is clear that but for Bachelor, there would have been no Huang or Cheney invention. It is my view that Bachelor‘s process and product had utility and that this was of a “practical” and “substantial” nature in the chemical arts for it provided a source of materials from which to develop other products not then known. Those in the penicillin art had no difficulty in understanding Bachelor‘s suggestion.
In this case and in Kirk, we see the deleterious effect of the dictum in the
An indication of use is not necessary in every case in view of
Many inventions, however, do not touch us so intimately in our daily lives as the transistor. Recently we considered a “non-linear code member.” In re Jones, 373 F.2d 1007, 54 CCPA —. The Patent Office did not question, nor did we, the “usefulness” of that invention. Had the Patent Office done so, however, how would we have approached the task of deciding that issue? If we should assume that we personally did not have knowledge of its “usefulness,” we would obviously be dependent upon others being able to communicate to us that the invention was useful. According to the specification in Jones, his invention was “useful” to those of ordinary skill in the pertinent art because a “half-quantum error” could be introduced in the distribution patterns upon the code member and thereafter corrected in the computer read-out equipment. While one of ordinary skill in the art could “see” the usefulness of this invention at once, will those not possessing those skills reach the same conclusion? This to me constitutes the grave error of the test here adopted by the majority for if the inventor cannot communicate to a judge that his invention is “useful” so that the judge understands this fact he will lose rights in what is in fact a “useful” invention to those of ordinary skill in the art. Why should the inventor‘s compensation for a full disclosure of his invention be dependent on the ability of an examiner or a judge to see the “usefulness” of the invention? The inventor should not have to in effect build a bridge from the judge‘s personal knowledge to his invention so that the judge then understands the “usefulness” of the invention.
It seems to me the issue can be properly and more simply resolved by proof of the fact that persons of ordinary skill in the art know how to and can use or are using the invention. Patent examiners and judges are qualified to
Thus, I am in basic disagreement with the premise underlying the majority opinions here and in Kirk. It leads to the wholly insupportable conclusion that objects of use to scientists in scientific research are not “useful” even though many scientists may in fact be using them to “promote the progress of science.” The fallacy in the majority‘s reasoning thus lies in its requirement that one who does not possess the knowledge or skills of one of ordinary skill in the art, must “see” and “understand” an asserted use for the disclosed invention before the requirements of
I do not believe that Manson holds otherwise. To construe that decision out of context, as does the majority, results in its being here applied contrary to the constitutional purpose underlying
The Board Erred in its Ruling on the Only Issue Before It
Turning to the instant case, the issue arising under
In this regard, I think it significant that the board here recognized that the skill of the art was such that the conversion of a chemical product from an ester to a keto product was obvious. It stated:
* * * Appellants claim compounds having an ester group on the 2-carbon. A recognized property of an ester is that it can be hydrolyzed to the corresponding alcohol. This is what appellants accomplish by their acid hydrolysis. The resulting alcohol is the enol form of the well-known keto-enol tautomerism, as will be seen by reference to standard chemical encyclopedias and dictionaries and text
books of organic chemistry, and a shift to the keto form occurs. Accordingly, it may properly be said that the claimed esters have the customary property of being convertible to the corresponding alcohols which, by virtue of their enol form, exhibit the property of converting into the tautomeric keto form.
In many cases how to use a chemical product can be determined from a consideration of its chemical structure. In the final analysis, utility of a chemical product necessarily lies in the employment of one or more of its properties. In re Folkers, 344 F.2d 970, 52 CCPA 1269 (1965). In fact, properties of a chemical product are often best described in terms of its uses, e. g., its properties as an adhesive, oxidizing agent, plasticizer, solvent, etc. Thus, is seems to me the how to use requirement of
The present record is such that the decision in Manson is clearly not applicable to the
The Section 101 Issue and the Misconstruction and Misapplication of Manson
It is my view that Manson is not controlling of the result on the
The present specification, in contrast, contains a specific disclosure of use of the claimed products C as reactants in a process of making the products D. Appellants state that the steroid products “are known to be useful in the formation of A-nor compounds.” This assertion stands unchallenged by the examiner.5 Here, the specification teaches that:
The products obtained by the invention, the lower organic carboxylic acid esters of enols in the 2-position of Δ1-steroids, are particularly useful as intermediates in the preparation of steroids, especially steroids having a ketone group in the 2-position, such as 21-acetoxy-pregnane-17α-ol-2,3,11,20-tetraone and [21-acetoxy] 16α-methyl-pregnane-17α-ol-2,3,11,20-tetraone by acid hydrolysis and customary separation steps. [Emphasis added]
Thus, not only does the present specification identify the materials to be used in the reaction but it further specifies the conversion processes as by “hydrolysis and customary separation steps.”6
It is my view that the
The Insupportable Rationale of the Majority Opinion
The final paragraph of the majority opinion reads:
We conclude that appellants have not discharged their burden to show that the claimed subject matter is “useful” within the requirements of
section 101 .
I do not agree either 1) that the examiner ever placed appellants under such a burden or 2) assuming they had this burden, that they failed to discharge it.
Appellants were asked to submit a memorandum on reargument. As to the claimed compounds, appellants state:
Pages 12 to 15 of appellant‘s brief point out how, by known methods, the compounds claimed herein can be converted into compounds of recognized utility, namely, A-nor-cortisone and its 16a methyl derivative. The Solicitor has not denied the factual correctness of this argument, but has merely urged that it should not be considered because it was not presented to the Patent Office. But this is not correct, for in the amendment of April 6, 1962 * * * it was argued that “one skilled in the art would know that the 2, 3, 11, 20-tetra-ones made from the claimed intermediates could be used to form the corresponding a-nor steroids.”
That is exactly the argument being made here, with some expansion by reference to standard text material, and to a patent showing actual utility for the product referred to (this patent having a filing date well ahead of appellants’ date). Appellants felt justified in assuming that the Examiner would be familiar with the reactions shown to be recognized by Fieser and Fieser [a standard textbook], and did not feel it necessary to amplify the argument when it was originally presented. [Emphasis added.]
The majority dismisses appellants’ evidence without consideration. Here I believe the majority errs for this evidence proves what appellants have argued throughout the prosecution: that one of ordinary skill in the art, i. e., a steroid chemist, would know that the claimed products were useful products for the production of products D and that they would know that products D were also useful products. The facts of record, simply stated, show that the board erred in its evaluation of what one of ordinary skill in this art should be presumed to know about the uses of the products C and D. It seems to me, therefore, that the board first raised an issue of fact by its challenge as to what a steroid chemist would know about the usefulness of the claimed products and processes. It then denied appellants any opportunity to refute its conclusions. This action of the board in thus making a new ground of rejection and refusing to label it as such was clearly prejudicial to appellants and this error is compounded by the majority.
The Board and the Majority Predicate their Conclusions on a Baseless Fact Issue
The record in this case will be searched in vain for any support whatsoever for the underlying factual assumption of the board that we are here concerned with a “useless” product or with its conversion into another “useless” product.
Here, as in the dissenting opinion in our decision in In re Manson, the unsupported designation of the product as “useless” raises a false fact issue of admittedly highly emotional appeal. The fact is that there is not here, nor was there in Manson, the slightest factual basis for such a characterization of either the product or the process!
The Patent Statute Applies Equally to All Inventors Without Regard to the Technical Fields to Which Their Inventions Relate
The view of the majority here that inventions in the chemical field require a standard of utility different from that in other technical areas, raises a very serious problem under the patent statute enacted pursuant to the power granted in
The Attitude of the Board of Appeals Toward Judicial Review Is Insupportable
Another aspect of the present case requires comment. The Board of Appeals in its opinion, after reviewing certain decisions of this court and of the Court of Appeals, D. C., found a conflict between the views of the courts and stated:
Faced with a conflict in the holdings of the two tribunals which review our decisions, we must determine which line of decisions to follow. We cannot lay down any general rule. We must be governed by our own best judgement and follow those decisions which, in our opinion, best define the spirit and the letter of the law until a higher tribunal or a specific statutory enactment resolves the conflict.1
However, the board by some logic, not apparent to me, not only ignores the decisions of this court but also fails to consider or apply the law of utility as enunciated by the Court of Appeals, D. C., in Canadian-American Pharmaceutical Co. v. Coe, 75 U.S.App.D.C. 313, 126 F.2d 847, (1942), followed in Ex parte Brahn, 65 USPQ 282 (P.O.Bd.App.1945). In the former case the Patent Office tribunals had rejected an application for a patent on “Ensol,” a medicine for reducing the pain of cancer, and on a process for its manufacture. The position of the board was that since “Ensol” had not been shown to check tumor growth, it was not “useful,” hence not patentable. The District Court agreed with the Patent Office that the disclosures lacked utility. The Patent Office and the District Court apparently proceeded on the concept, as would the majority here, that unless there was a “practical” and “substantial” utility of curing cancer, the drug was “useless.” The District Court‘s decision was reversed on appeal. Judge Edgerton‘s opinion concludes with the following statement, 126 F.2d at 848:
It may be that some medical scientists would discourage the use of Ensol pending further tests. It is not within our function to decide, and we do not assume to decide, whether its use should be encouraged or discouraged. But we do have to decide whether under the evidence in the record in this case it has been clearly shown to have utility within the meaning of the patent law. And the evidence seems to us to make it clear that Ensol does, in many cases, reduce the pain of cancer, and that it causes no serious harm. There is no finding, and no evidence, to the contrary. It follows that Ensol has an “important function” and “works.” In our opinion, the District Court‘s finding that the invention is not sufficiently reliable, useful and important to warrant the grant of a patent is incorrect. [Emphasis added.]
Thus, the only “policy” which seems to have governed the Board of Appeals here is that which ignores all decisions, either of this court or of the Court of Appeals, D. C., which may be in conflict with its “own best judgment.” Such a capricious rule substitutes the whims and notions of the individual members of the Board of Appeals for the decisional law of the courts which Congress has duly authorized to decide such matters. The majority passes this arrogation of authority without comment!
Conclusion
It is but a sign of human frailty to fear that which we do not understand. The first automobiles were but “Rich Men‘s Toys,” allegedly devoid of practical application which, it was thought, would never replace the horse, until innovative pioneers in this field taught mankind to understand and appreciate them. They were indeed “useless” to the farmer whose horses, terrified by them, ran away, damaged property and took lives. Basically, all progress is predicated on the ultimate acceptance of new ideas which at their inception, were understood only by a few who possessed the special education and skills necessary to understand the idea, and were “useless” to the vast majority of people.
Here, and in Kirk, the majority opinions seem to proceed from some lack of appreciation of the new and unobvious inventions here in issue. Had their disclosure been couched in the language descriptive of a scientific educational
Candor and completeness of disclosure in patent applications must be encouraged if the patent system is to serve its constitutional purpose. The decisions here and in Kirk, extending as they do the dictum in Manson, place a premium on subterfuge. One may imagine numerous allegations of use for the present products and process which, I suspect, would be accepted by the majority.
However, because appellants spoke to steroid chemists in a language which they mutually understood and discussed the utility of their process and products in these terms, the board and the majority have here penalized them. I do not question but that a producer of chemical products for sale to research workers could well practice appellants’ process and produce the products C. The very fact that such products can be thus made available permits the researcher in the challenging areas of steroid chemistry to devote more of his time to that research instead of being required to first invent the chemical products necessary for his investigation.
The history of technological and scientific progress is full of examples in which availability of a particular material governs the decision as “to feasibility for many of a research idea in its early fetal stages,” see the KODAK Company advertisement, supra. Without the earlier development and availability of heat-resistant refractory metals for its blades, a jet engine is impractical. Without products developed from special rare earth metals, color television is similarly impractical. Without the basic tools and materials of research, progress is retarded. It is precisely in this area in which I see the greatest dangers flowing from the fallacies upon which the majority opinion is based.
Without patent protection on their new steroid products and the processes for manufacturing them, how can appellants afford to disclose these products and make them available to other research workers in the steroid field? Unless it is made economically feasible for them to do so, how can we assure the continued flow of just such research tools to the scientific community? The inventors of chemical tools should neither be discriminated against nor confused with those who devise ways and purposes to apply those tools.
These policy considerations seem to me to outweigh in public importance the alleged unsupported dangers recited in the Manson dictum. The policy considerations in Manson were far different from those which are here postulated. The issues before the court in Manson necessarily involved the policy of issuing the patent to the first inventor and discouraging unnecessary interferences. On this issue Manson can be said to be in harmony with sound public policy.
Here, however, since there is no such issue, we should, it seems to me, balance the encouragement of early filing of candid disclosures against the ambiguity as to what is meant by “useful” in
The majority‘s affirmance of the board proceeds from its adoption of the Board of Appeals’ characterization of appellants’ claimed products and processes as “useless.” The board‘s conclusion is based on its unsupported assumption of fact which the majority does not question. No opportunity was afforded appellants to meet this issue. Thus, they have been denied a potentially valuable property right without due process.
The board‘s opinion evidences its preoccupation with the game of “cat‘s cradle.”7 The board opinion states:
* * * The operations involved in that game may be described in perfect detail but, aside from the entertainment or amusement aspects of the game, the process cannot be said to be useful. Similarly, the method here claimed may be an interesting exercise in chemical processing, but this does not mean that the process is useful, absent the production of a useful end product.
In its opinion we are introduced to what the board terms a “chemical version of cat‘s cradle.” Were it not for the tragic end of this story, such an allusion might well be passed as a bit of imaginative and even entertaining writing. Here, however, the “endless string” with which the board played out its own little game in not complying with
The injustice done appellants cries out to be remedied.
APPENDIX
Appellants’ invention relates to esters of steroids of the Δ1-pregnene series and to a process for their preparation. More particularly, appellants disclose members of the Δ1-pregnene series having lower organic carboxylic acid esters of enols in the 2-position thereof, which may also have a methyl group in the 16-position. Claim 1, generic to the disclosed class of compounds, is reproduced here with appropriate numbering of the various positions added:
-
A compound having the formula
Image Placeholder #1wherein X is selected from the group consisting of hydrogen and methyl, Y is selected from the group consisting of hydrogen and an acyloxy radical of a
lower organic carboxylic acid having 1 to 7 carbon atoms and Y’ is an acyl radical of a lower organic carboxylic acid having 1 to 7 carbon atoms.
Claims 2 and 3 are specific to 2,21-diacetoxy - Δ1 - pregnene - 17α- ol-3,11,20-trione and 2-acetoxy-16α-methyl-Δ1-pregnene-17α-ol-3,11,20-trione, respectively. Since the steroid has an =O group at each of the 3,11 and 20-positions it is called a trione. The nomenclature “Δ1” has reference to the double bond between the 1- and 2-position carbon atoms. The ester group produced by the process is the Y‘O-group at the 2-position. The positions 1-4 are all contained in the so-called “A” ring, of the four-ringed steroid nucleus.
Regarding the process for producing the esters, appellants first note that four prior art processes for producing an ester function or group at the 2-position in the A ring of steroids have been “generally very laborious.” Appellants state in the specification
* * * By these processes, esters of enols of the series of androstane have been prepared. For example, the 2,17-diacetoxy - 3 - oxo - Δ1,4 - androstadiene has been prepared by oxidation of the 2α-hydroxy testosterone with bismuth trioxide at an elevated temperature and by esterification of the oxidized product with acetic anhydride [Baran J. Am. Chem. Soc. 80, 1687 (1958)].
On the other hand, the Δ1-2-hydroxy steroids of the androstane series can be obtained by microbiological methods starting from the 2α-hydroxy testosterone and the dehydrogenated product can be esterified as has been described previously. [Gual et al, J. Org. Chem. 24, 418 (1959)].
Other processes for obtaining the 2-enols of 2,3-diones are found in the literature, such as oxidation of a 3-oxo steroid by means of selenium dioxide with production of the corresponding Δ1-2-hydroxyl compound [Stiller et al, J. Chem. Soc., 353 (1938)] and the condensation of a bromide of the 2-pyridinium compound with the p-nitrosodimethyl aniline and hydrolysis of the resulting nitrone [Ruzicka, Helv. Chim. Acta 27, 524 (1944)].
In contrast, appellants’ method, as they note in the specification, is quite “simple and advantageous because it gives high yields while operating at room temperatures for both steps of the process.”
Appellants start with a corresponding 2,4-dibromo derivative1 of the pregnane, reacting it with pyridine to obtain the corresponding 2-pyridinium-4-bromo-pregnane-3-one, and reacting that pyridinium intermediate with an alkaline salt of a lower organic carboxylic acid having 1-7 carbon atoms (e. g., sodium acetate) in the presence of an N,N-dialkylamide of a lower alkanoic acid (e. g., dimethyl formamide). Thus, claim 12 reads:
-
A process for the preparation of lower organic carboxylic acid esters of 2-enols of Δ1-pregnene-3-one having the formula
Image Placeholder #2wherein X is selected from the group consisting of hydrogen and methyl, Y is selected from the group consisting of hydrogen and an acyloxy radical of a lower organic carboxylic acid having 1 to 7 carbon atoms and Y’ is an acyl radical of a lower organic carboxylic acid having 1 to 7 carbon atoms which comprises reacting pyridine with the
2,4-dibromo derivative of a pregnane having the formula Image Placeholder #3wherein X and Y have the above definitions to form the corresponding bromide of the 2-pyridinium-4-bromo derivative of the said pregnane, reacting the latter with a salt of a lower organic carboxylic acid having 1 to 7 carbon atoms in the presence of an N,N-dilower alkyl amide of a lower alkanoic acid to form the lower organic carboxylic acid esters of the said 2-enols and recovering the latter.
Appellants’ Table I is reproduced here, with numbers labelling the processing steps added, to further explain the invention:
TABLE I
The added letters represent products referred to in the diagram previously discussed.
wherein X = CH3- or H-,
Y = H- or acyloxy radical of a lower organic carboxylic acid having 1 to 7 carbon atoms,
and Y’ is an acyl radical of a lower organic carboxylic acid having 1 to 7 carbon atoms.
Referring to the table above, appellants’ claimed process covers steps 1 and 2. Thus the claimed process converts a starting material A to an intermediary B which, in turn, is converted to the claimed product C.
Appellants’ product C, an ester of the 2-position enol, may itself be converted to a compound D by acid hydrolysis. Compound D is variously called a 2,3-dione, a 2,3 diketo steroid or a 2,3,11,20-
Besides the utility of the process as a means for placing an ester group in the 2-position of such steroid molecules, appellants’ application discloses that:
The products obtained by the invention, the lower organic carboxylic acid esters of enols in the 2-position of Δ1-steroids are particularly useful as intermediates in the preparation of steroids, especially steroids having a ketone group in the 2-position, such as 21-acetoxy-pregnane-17α-ol-2,3,11,20-tetraone and 16α-methyl-pregnane-17α-ol-2,3,11,20-tetraone by acid hydrolysis and customary separation steps.
Although the examiner finally rejected all the claims for failure “to present an adequate disclosure of utility as required by
Applicants in reply stated, inter alia:
Applicants also wish to point out that 2,3-diketo steroids are known to be useful in the formation of A-nor steroids according to the following reaction:
Image Placeholder #6One skilled in the art would know that the 2,3,11,20-tetraones made from the claimed intermediates could be used to form the corresponding A-nor steroids.
The examiner adhered to his position and appellants then appealed to the board. The examiner‘s position in his Answer on appeal remained the same:
* * * Nowhere in the specification have the applicants alleged or made any reference to a useful property possessed by the instant 2-keto compounds, that result from the above stated reaction. The fact is not controverted that the applicants have shown a method of converting the claimed compounds into another compound; however, it is maintained that the final product has not been shown to possess any specific utility that would be readily apparent to those skilled in the art. It is obvious that most compounds can be converted or modified in some manner; however, such a conversion is not deemed to be a basis upon which an applicant may base an assumption of utility and thus satisfy the requirements of
section 112 of the Code. As the application now stands, those engaged in the steroid field would be left totally uninformed as to what could be done with the applicants’ final products and would be forced to perform further research on their own, to render the compounds of value in the art. * * *
The examiner also distinguished In re Nelson, 280 F.2d 172, 47 CCPA 1031 (1960), on the grounds that the claimed end product, 14-hydroxy-androstenes, in Nelson could be used in well-known reactions to produce steroids of a class at least some members of which are known to have useful therapeutic properties. The examiner stated:
A situation comparable to the above does not exist in the application under
consideration. Novelty of the claimed compounds is not questioned, however the claimed 2-enols of the Δ1-pregnenes do not belong to a class of compounds known to have the therapeutic properties or any other readily apparent utility. The identical situation exists relative to the corresponding 2,3-keto compounds which the applicants derive from the claimed compounds by acid hydrolysis and customary separation. While it is possible that through further research, efforts by others may develop important uses for the claimed compounds, it cannot be disputed that no such disclosure exists in the specification as filed nor are such useful ends readily apparent to those skilled in the art.
The board recognized that if satisfactory utility for the products had been established all the claims would be patentable. The board, however, for the first time mentioned
* * * However, absent a situation where an applicant is seeking the same claims on the same disclosure as was involved in the cited case, the Nelson et al. decision cannot be regarded as controlling on facts. Each case must of necessity, be determined in view of its own particular facts.
Regarding appellants’ assertion that the 2,3-diketo compounds could be converted to A-nor compounds by known procedures, the board was of the view that they were merely postulated reactions having no support in publications or patents to show that they were known prior to appellants’ filing date. The board also noted that the reactions were not disclosed in the specification as filed, that there was nothing to show the reactions in fact could be successfully accomplished, and that there was no showing that the ultimate A-nor compounds “have any utility.”
Notes
* * * there is nothing to indicate that the derivative dicarboxylic acid compounds or the ultimate A-nor compounds have any utility. * * * A detailed technical discussion at this time would only obscure the issues so it has been separately written as the “appendix” to this opinion.