35 U.S.C. 102 Conditions for patentability; novelty.

[Editor Note: Applicable to any patent application subject to the first inventor to file provisions of the AIA (see 35 U.S.C. 100 (note) ). See pre-AIA 35 U.S.C. 102 for the law applicable to applications and patents not subject to the first inventor to file provisions of the AIA.]

1. (a) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
   1. (1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or
   2. (2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
2. (b) EXCEPTIONS.—
   1. (1) DISCLOSURES MADE 1 YEAR OR LESS BEFORE THE EFFECTIVE FILING DATE OF THE CLAIMED INVENTION.—A disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if—
      1. (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or
      2. (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor.
   2. (2) DISCLOSURES APPEARING IN APPLICATIONS AND PATENTS.—A disclosure shall not be prior art to a claimed invention under subsection (a)(2) if—
      1. (A) the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor;
      2. (B) the subject matter disclosed had, before such subject matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or
      3. (C) the subject matter disclosed and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person.
3. (c) COMMON OWNERSHIP UNDER JOINT RESEARCH AGREEMENTS.—Subject matter disclosed and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person in applying the provisions of subsection (b)(2)(C) if—
   1. (1) the subject matter disclosed was developed and the claimed invention was made by, or on behalf of, 1 or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention;
   2. (2) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and
   3. (3) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement.
4. (d) PATENTS AND PUBLISHED APPLICATIONS EFFECTIVE AS PRIOR ART.—For purposes of determining whether a patent or application for patent is prior art to a claimed invention under subsection (a)(2), such patent or application shall be considered to have been effectively filed, with respect to any subject matter described in the patent or application—
   1. (1) if paragraph (2) does not apply, as of the actual filing date of the patent or the application for patent; or
   2. (2) if the patent or application for patent is entitled to claim a right of priority under section 119, 365(a), 365(b), 386(a), or 386(b), or to claim the benefit of an earlier filing date under section 120, 121, 365(c), or 386(c) based upon 1 or more prior filed applications for patent, as of the filing date of the earliest such application that describes the subject matter.

35 U.S.C. 102 (pre-AIA) Conditions for patentability; novelty and loss of right to patent.

[Editor Note: With the exception of subsection (g) in limited circumstances, not applicable to any patent application subject to the first inventor to file provisions of the AIA (see 35 U.S.C. 100 (note) ). For an application or patent subject to the first inventor to file provisions of the AIA, see 35 U.S.C. 102.]

A person shall be entitled to a patent unless —

1. (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or
2. (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or
3. (c) he has abandoned the invention, or
4. (d) the invention was first patented or caused to be patented, or was the subject of an inventor’s certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor’s certificate filed more than twelve months before the filing of the application in the United States, or
5. (e) the invention was described in — (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language; or
6. (f) he did not himself invent the subject matter sought to be patented, or
7. (g)(1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.

35 U.S.C. 103 Conditions for patentability; non-obvious subject matter.

[Editor Note: Applicable to any patent application subject to the first inventor to file provisions of the AIA (see 35 U.S.C. 100 (note) ). See pre-AIA 35 U.S.C. 102 for the law applicable to applications and patents not subject to the first inventor to file provisions of the AIA.]

A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.

35 U.S.C. 103 (pre-AIA) Conditions for patentability; non-obvious subject matter.

[Editor Note: Not applicable to any patent application subject to the first inventor to file provisions of the AIA (see 35 U.S.C. 100 (note) ). For an application or patent subject to the first inventor to file provisions of the AIA, see 35 U.S.C. 103.]

1. (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
2. (b)
   1. (1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if-
      1. (A) claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and
      2. (B) the composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person.
   2. (2) A patent issued on a process under paragraph (1)-
      1. (A) shall also contain the claims to the composition of matter used in or made by that process, or
      2. (B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154.
   3. (3) For purposes of paragraph (1), the term "biotechnological process" means-
      1. (A) a process of genetically altering or otherwise inducing a single- or multi-celled organism to-
         1. (i) express an exogenous nucleotide sequence,
         2. (ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or
         3. (iii) express a specific physiological characteristic not naturally associated with said organism;
      2. (B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and
      3. (C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B).
3. (c)
   1. (1) Subject matter developed by another person, which qualifies as prior art only under one or more of subsections (e), (f), and (g) of section 102, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the claimed invention was made, owned by the same person or subject to an obligation of assignment to the same person.
   2. (2) For purposes of this subsection, subject matter developed by another person and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person if —
      1. (A) the claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made;
      2. (B) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and
      3. (C) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement.
   3. (3) For purposes of paragraph (2), the term "joint research agreement" means a written contract, grant, or cooperative agreement entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention.

I. CHOICE OF PRIOR ART; BEST AVAILABLE

Prior art rejections should ordinarily be confined strictly to the best available art. Exceptions may properly be made, for example, where:

1. (A) the propriety of a 35 U.S.C. 102 or 103 rejection depends on a particular interpretation of a claim;
2. (B) a claim is met by a prior art disclosure which does not disclose the inventive concept involved;
3. (C) for cases examined under the first inventor to file provisions of the AIA, the most pertinent disclosure could be shown not to be prior art by invoking an exception in a 37 CFR 1.130 affidavit or declaration of attribution or prior public disclosure;
4. (D) for cases examined under pre-AIA law, an obviousness rejection is based on prior art that qualifies only under pre-AIA 35 U.S.C. 102(e), (f), or (g) so that the rejection could be overcome by establishing that the prior art is disqualified under pre-AIA 35 U.S.C. 103(c); or
5. (E) for cases examined under pre-AIA law, the most pertinent disclosure could be antedated by a 37 CFR 1.131 affidavit or declaration of prior invention.

In the interest of compact prosecution, such rejections should be backed up by the best other art rejections available. Keep in mind the best backup rejection(s) could be based on alternate embodiments from the same "best available" reference(s). For example, if an anticipation rejection could be overcome by invoking an exception in a 37 CFR 1.130(b) declaration, it would be appropriate to make an additional obviousness rejection over another disclosure in the same reference. Merely cumulative rejections, i.e., those which would clearly fall if the primary rejection were not sustained, should be avoided.

See also MPEP § 707.05.

II. RELIANCE UPON ABSTRACTS AND FOREIGN LANGUAGE DOCUMENTS IN SUPPORT OF A REJECTION

Prior art uncovered in searching the claimed subject matter of a patent application often includes English language abstracts of underlying documents, such as technical literature or foreign patent documents which may not be in the English language. When both the abstract and the underlying document qualify as prior art, the underlying document should normally be used to support a rejection. When an abstract is used to support a rejection, the evidence relied upon is the facts contained in the abstract, not additional facts that may be contained in the underlying full text document. Citation of and reliance upon an abstract without citation of and reliance upon the underlying scientific document is generally inappropriate where both the abstract and the underlying document are prior art. See Ex parte Jones, 62 USPQ2d 1206, 1208 (Bd. Pat. App. & Inter. 2001) (unpublished). To determine whether both the abstract and the underlying document are prior art, a copy of the underlying document must be obtained and analyzed. If the document is in a language other than English and the examiner seeks to rely on that document, a translation must be obtained so that the record is clear as to the precise facts the examiner is relying upon in support of the rejection. The record must also be clear as to whether the examiner is relying upon the abstract or the full text document to support a rejection. The rationale for this is several-fold. It is not uncommon for a full text document to reveal that the document fully anticipates an invention that the abstract renders obvious at best. The converse may also be true, that the full text document will include teachings away from the invention that will preclude an obviousness rejection under 35 U.S.C. 103, when the abstract alone appears to support the rejection. An abstract can have a different publication date than the full text document. Because all patentability determinations are fact dependent, obtaining and considering full text documents at the earliest practicable time in the examination process will yield the fullest available set of facts upon which to determine patentability, thereby improving quality and reducing pendency. In limited circumstances, it may be appropriate for the examiner to make a rejection in a non-final Office action based in whole or in part on the abstract only without relying on the full text document. In such circumstances, the full text document and a translation (if not in English) may be supplied in the next Office action.

Examiners may rely on a machine translation of a foreign language document unless the machine translation is not of sufficient quality to be adequate evidence of the contents of the document. See In re Orbital Technologies Corporation, 603 Fed. App’x 924, 932 (Fed. Cir. 2015). A request by the applicant for the examiner to obtain a human language translation should be granted if the applicant provides evidence (e.g., a translation inconsistent with the machine translation) showing the machine translation does not accurately represent the document’s contents.

An Office action supplying a full text document and/or translation may be made final if the conditions described in MPEP § 706.07(a) or for a first Office action or RCE, in MPEP § 706.07(b), have been met.

Some translation resources available to examiners are discussed in MPEP § 901.05(d).

III. DISTINCTION BETWEEN 35 U.S.C. 102 AND 103

The distinction between rejections based on 35 U.S.C. 102 and those based on 35 U.S.C. 103 should be kept in mind. Under the former, the claim is anticipated by the reference. No question of obviousness is present. In other words, for anticipation under 35 U.S.C. 102, the reference must teach every aspect of the claimed invention either explicitly or impliedly. Any feature not directly taught must be inherently present. Whereas, in a rejection based on 35 U.S.C. 103, the reference teachings must somehow be modified in order to meet the claims. The modification must be one which would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for applications or patents subject to the first inventor to file provisions of the AIA or at the time the invention was made for applications or patents subject to pre-AIA law. See MPEP §§ 2131 - 2146 and 2150 - 2159.04 for guidance on patentability determinations under 35 U.S.C. 102 and 103.

Once the examiner conducts a search and finds a printed publication or patent which discloses the claimed invention, the examiner should determine whether the rejection should be made under 35 U.S.C. 102(a)(1) or (a)(2) or, if the application is subject to the former prior art regime, pre-AIA 35 U.S.C. 102(a), (b), or (e). See MPEP § 2159 for guidance. Form paragraph 7.03.aia or 7.03.fti should be used in an Office action to indicate whether the application is being examined under the first inventor to file provisions of the AIA or the pre-AIA prior art provisions, respectively.

The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA.

Examiner Note:

This form paragraph should be used in any application subject to the first inventor to file provisions of the AIA.

The present application, filed on or after March 16, 2013, is being examined under the pre-AIA first to invent provisions.

Examiner Note:

This form paragraph should be used in any application filed on or after March 16, 2013 that is subject to the pre-AIA prior art provisions.

In order to determine which paragraph of 35 U.S.C. 102 applies, the effective filing date of each claimed invention must be determined and compared with the date of the reference. See MPEP § 2139.01 regarding determination of effective filing date of the claimed invention under pre-AIA law and MPEP § 2152.01 regarding determination of effective filing date of the claimed invention under AIA law.

The examiner must also determine the issue or publication date of the reference so that a proper comparison between the application and reference dates can be made. See MPEP §§ 2124, 2126, 2128 - 2128.02, and 2152.02 - 2154.02(c) for case law relevant to reference date determination.

See MPEP § 2152.05 for determining whether to apply 35 U.S.C. 102(a)(1) or (a)(2). See MPEP § 2139.02 for determining whether to apply pre-AIA 35 U.S.C. 102(a), (b), or (e).

In all applications, an applicant may overcome a 35 U.S.C. 102 rejection by persuasively arguing that the claims are patentably distinguishable from the prior art, or by amending the claims to patentably distinguish over the prior art. Additional ways available to overcome a rejection based on 35 U.S.C. 102 prior art depend on whether or not any claim in the application being examined is subject to the first inventor to file provisions of the AIA.

See MPEP § 2152.06 for overcoming a rejection under 35 U.S.C. 102(a)(1) or (a)(2). See MPEP §§ 2132.01, 2133.02(a), and 2136.05 et seq. for overcoming prior art rejections under pre-AIA 35 U.S.C. 102(a), (b), and (e), respectively.

An applicant may make an admission, or submit evidence of sale of the invention or knowledge of the invention by others, or the examiner may have personal knowledge that the invention was sold by applicant or known by others. See MPEP §§ 2152.02(c)-2152.02(e) for a discussion of when public use of a claimed invention, placing a claimed invention on sale, or otherwise making a claimed invention available to the public might preclude patentability under 35 U.S.C. 102(a)(1). See MPEP §§ 2132 and 2133.03 et seq. for a discussion of when public knowledge, public use, or sale of a claimed invention might preclude patentability under pre-AIA 35 U.S.C. 102(a) or (b). If the activity is by an entity other than the inventor or assignee, such as sale by another, manufacture by another or disclosure of the invention by applicant or the inventor to another then both pre-AIA 35 U.S.C. 102(a) and (b) may be applicable. If the evidence only points to knowledge within the year prior to the effective filing date then pre-AIA 35 U.S.C. 102(a) applies. However, no rejection under pre-AIA 35 U.S.C. 102(a) should be made if there is evidence that the inventor made the invention and only disclosed it to others within the year prior to the effective filing date.

Note that as an aid to resolving public use or on sale issues, as well as to other related matters of public availability or public knowledge, an applicant may be required to answer specific questions posed by the examiner and to explain or supplement any evidence of record. See 35 U.S.C. 132 and 37 CFR 1.104(a)(2). Information sought should be restricted to that which is reasonably necessary for the examiner to render a decision on patentability. The examiner may consider making a requirement for information under 37 CFR 1.105 where the evidence of record indicates reasonable necessity. See MPEP § 704.10 et seq.

A 2-month time period should be set by the examiner for any reply to the requirement, unless the requirement is part of an Office action having a shortened statutory period, in which case the period for reply to the Office action will also apply to the requirement. If applicant fails to reply in a timely fashion to a requirement for information, the application will be regarded as abandoned. 35 U.S.C. 133.

If there is not enough information on which to base a public use or on sale rejection, the examiner should make a requirement for more information. Form paragraph 7.104.aia or 7.104.fti can be used.

An issue of public use, on sale activity, or other public availability has been raised in this application. In order for the examiner to properly consider patentability of the claimed invention under 35 U.S.C. 102(a)(1), additional information regarding this issue is required as follows: [1]

Applicant is reminded that failure to fully reply to this requirement for information will result in a holding of abandonment.

Examiner Note:

1. This form paragraph must be preceded by form paragraph 7.105, and should be followed by form paragraphs 7.122 – 7.126 as appropriate.

2. This form paragraph should only be used in an application filed on or after March 16, 2013, where the claims are being examined under 35 U.S.C. 102 /103 as amended by the Leahy-Smith America Invents Act. This form paragraph must be preceded by form paragraph 7.03.aia.

3. Information sought should be restricted to that which is reasonably necessary for the examiner to render a decision on patentability. See MPEP § 2133.03.

4. A two month time period should be set by the examiner for reply to the requirement unless it is part of an Office action having a shortened statutory period (SSP), in which case the period for reply will apply also to the requirement.

5. If sufficient evidence already exists to establish a prima facie case of public use, sale, or other public availability use form paragraph 7.16.aia to make a rejection under 35 U.S.C. 102(a)(1). See MPEP § 2133.03.

An issue of public use or on sale activity has been raised in this application. In order for the examiner to properly consider patentability of the claimed invention under pre-AIA 35 U.S.C. 102(b), additional information regarding this issue is required as follows: [1]

Applicant is reminded that failure to fully reply to this requirement for information will result in a holding of abandonment.

Examiner Note:

1. This form paragraph must be preceded by form paragraph 7.105, and should be followed by form paragraphs 7.122 –7.126 as appropriate.

2. Information sought should be restricted to that which is reasonably necessary for the examiner to render a decision on patentability. See MPEP § 2133.03.

3. A two month time period should be set by the examiner for reply to the requirement unless it is part of an Office action having an SSP, in which case the SSP will apply also to the requirement.

4. If sufficient evidence already exists to establish a prima facie case of public use or on sale, use form paragraph 7.16.fti to make a rejection under pre-AIA 35 U.S.C. 102(b). See MPEP § 2133.03.