525 F.2d 1059 | C.C.P.A. | 1975
This appeal is from a decision of the Patent and Trademark Office Board of
The Invention
According to appellant’s specification, an inadequate supply of either vitamin B12 (cyanocobalamin) or folic acid in the human diet results in fewer healthy red blood cells, producing the symptoms of anemia. Whether the condition is due to vitamin B12 deficiency or folic acid deficiency, or to a combination of the two, is difficult, expensive, and time consuming to determine. The determination has been deemed critical. Treatment of a vitamin B12 deficient patient with folic acid alone may result in an apparent cure or “masking” of continuing neurological effects of the deficiency and possible irreversible injury or death. Similarly, masking of a folic acid deficiency by administration of vitamin Bi2 alone may result in death, according to appellant’s teachings.
Within this context appellant has proposed a solution whereby an oral hematinic multifactor vitamin preparation is administered, the preparation containing both vitamin B12 and folic acid, each in the amount of at least .1 milligram. Appealed claims 1 and 11 are illustrative:
I. In an improved oral multifactor hematinic vitamin preparation which contains vitamin B12 and folic acid, the improvement which comprises having at least 0.1 milligram of vitamin B12 and at least 0.1 milligram of folic acid, in an approximate one to one ratio.
II. A method of treating the preventing anemia in humans which comprises administering a daily oral dosage of a vitamin preparation containing at least .5 mg. of vitamin B12 and at least .5 mg. of folic acid, whereby anemia can safely be treated orally without determining whether it is caused by folic acid deficiency or by vitamin B12 deficiency.
The Rejection
The references cited by the examiner are as follows:
Jurist 2,748,054 May 29, 1956
Sahyun 2,804,423 Aug. 27, 1957
Merck Index 105, 455, 467-68, 729, 892, 918-19,1036-37,1112-13 (8th ed. 1968)
Physicians’ Desk Reference (PDR1 738, 915, 1084,1104, 1129 (1968)
Waife et al., Oral Vitamin B-^ without Intrinsic Factor. 58 Annals of Internal Med. 810-16 (1963).
The board added “pages 752, 811, and 812 to the Examiner’s citation of Physicians’ Desk Reference (PDR),” noting that the Peritinic and Zentinic preparations described therein correspond generally to certain “widely distributed formulation[s]” alluded to in appellant’s specification.
What the prior art teaches is not in dispute. Appellant has admitted that it is well known to treat a patient having folic acid deficiency with folic acid alone in the amounts claimed. It is also well known to administer folic acid in an oral preparation. The oral administration of vitamin B12 alone in the amounts claimed is disclosed in the Waife et al. reference, coauthored by appellant. Oral preparations containing both vitamin B12 and folic acid are also known, although such combination preparations do not contain the amounts claimed by appellant. Zentinic and Peritinic, for instance, are commercially available oral multifactor hematinic vitamin preparations containing .05 milligram of folic acid and .05 milligram of vitamin B12, exactly half the minimum recommended dosage claimed by appellant.
The board had the following comments relative to appellant’s asserted contribution, which it referred to as a “shotgun approach” to the control of undifferentiated anemia:
We refrain from becoming involved in the medical controversy over the rationality of the shotgun approach. We realize that some condemn the shotgun*1061 technique in that it encourages slovenly diagnosis and may result in dangerous “overkill.” The contrary argument is that if the shotgun system is not dangerous, no harm is done in administering a broad spectrum of combined therapeutic agents. Our only concern is whether a shotgun composition is obvious rather than whether some ' practitioners would condemn such a composition.
The essence of appellant’s position is that because combination therapy is viewed with disfavor by some, it must be unobvious to formulate a combination therapeutic preparation. We cannot agree with appellant’s conclusion, despite his emphasis on the premise.
The board perceived “nothing unexpected” in appellant’s composition, noting that it would be “entirely expected that a combination preparation may be used for an undifferentiated disorder.” Moreover, it was determined that appellant’s claims, specifying “at least 0.1 milligram of vitamin B12 and at least 0.1 milligram of folic acid,” were difficult to distinguish from “a double strength tablet” of Zentinic or Peritinic. It was further found that a “double strength tablet” of Theragran Hematinic, which contains .05 milligram of vitamin B12 and .5 milligram of folic acid, would be pertinent to claim 8, which does not require a one-to-one ratio of vitamin B^ to folic acid. On reconsideration the board clarified its position. somewhat by commenting:
As noted in our decision, vitamin B12 and folic acid have been included in a single composition and, with respect to dosages, the recommended two-tablet daily dose of Peritinic or Zentinic, corresponds to the terms of claims 1, 2, and 8, with a two-tablet daily dose of Theragran Hematinic also corresponding to the terms of claim 8.
OPINION
We agree with the board that it would have been obvious to formulate and use a composition containing both folic acid and vitamin Bi2 in the recognized individual therapeutic dosages.
Appellant’s position is that he has solved the problem of treating anemia in an unobvious way. Appellant relies upon evidence, also considered by the board, tending to show that some or perhaps even most persons having ordinary skill in the art would regard the claimed preparation as unsafe for treating certain types of anemia. A letter from Marvin Seife, M.D., Acting Director, Office of Scientific Evaluation, Bureau of Drugs, Food and Drug Administration stated:
Your views on the safety and efficacy of your proposed product are not shared by the preponderance of contemporary scientific medical opinion.
Dr. Seife’s letter quoted from a medical textbook:
It is therefore incumbent on the physician never to prescribe a multivitamin preparation containing more than .1 mg. of folic acid per daily dose unless he is reasonably sure that the patient does not have vitamin Bi2 deficiency.
A similar statement, apparently reflecting the opinion of the American Medical Association, is expressed in AMA Drug Evaluations 61 (1st ed. 1971):
Combination therapy is indicated only when it can be clearly demonstrated that one type of anemia is superimposed upon another. Even under these circumstances, a combination of the specific agents lacking in the particular anemias diagnosed are the only agents that should be used to treat the anemias. Not only is avoidance of mixtures superior therapy from the standpoint of good medical practice, but also it may be absolutely necessary because the preferred route of administration of two different therapeutic agents may be entirely different. For example, an iron deficiency anemia superimposed on a pernicious anemia re*1062 quires both iron and cyanocobalamin for treatment. However, the oral route is preferred for administering iron, whereas cyanocobalamin should be given by intramuscular or deep subcutaneous injection for best results.
Appellant raises an unnecessary issue in arguing that the board has jurisdiction to consider opinions of the Food and Drug Administration and others concerning the safety and effectiveness of the claimed composition insofar as such opinions may relate to the question of obviousness under section 103, citing In re Anthony, 414 F.2d 1383, 56 CCPA 1443 (1969). The board properly cited In re Anthony as authority for its reversal of a rejection under 35 U.S.C. § 101 and thereafter proceeded, in its review of the rejection under 35 U.S.C. § 103, to consider fully the opinion evidence respecting safety submitted by appellant. Nothing in In re Anthony militates against jurisdiction of the board to consider such evidence in relation to the question of obviousness. The board determined, however, that such evidence was not persuasive of unobviousness in the claimed subject matter. We agree with that determination.
Whether members of the medical community agree or disagree with appellant’s “shotgun approach” to treating undifferentiated anemia cannot control the determination of whether appellant’s claimed combination product and method would have been unobvious to a person having ordinary skill in the art. The prior art is replete with examples of commercially available hematinic vitamin preparations containing combinations of vitamin B12 and. folic acid. Hence, there is nothing new or unobvious in the combination per se. Neither is there anything new or unobvious about the individual dosage levels for vitamin Bi2 and folic acid employed by appellant.
Appellant asserts a theory concerning the manner in which the claimed composition and method effectively treat undifferentiated anemia. We express no view on the merit of that theory. Appellant’s theory, however, cannot remove the effect of the prior art, which establishes that the claimed composition and method would have been obvious to one of ordinary skill in the art.
Accordingly, the decision of the Patent and Trademark Office is affirmed.
Affirmed.
Goodman & Gilman, The Pharmacological Basis of Therapeutics, 1440 (4th ed. 1970).
