DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of sequence ID no. 1 in the reply filed on 2025 July 7 is acknowledged. Claims 1-10 and 22 are examined on the merits.
Claims 11-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2025 July 7.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/976654, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 62/976654 does not provide support for sequences 1-19 because it does not disclose any of these sequences. Consequently the effective filing date of examined group I is 2021 February 12.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2022 December 6, 2024 July 29, and 2025 May 6 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-10 and 22 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to lack of written description.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, claims 1-10 and 22 are drawn to a peptide comprising at least 70% sequence identity to a peptide of sequence ID no. 1.
(1) Level of skill and knowledge in the art:
DRMANAC (WO 0175067, published 2001 October 11). Drmanac describes sequence ID no. 37300 (page 101, claim 20, alignment shown below), a 159 amino acid protein.
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(2) Partial structure:
A peptide in which at least 7 out of 10 amino acids are the same to sequence ID no. 1 represents a partial structure. Up to three of the ten amino acids can be replaced with a conservative or non-conservative substitution. Each position of sequence ID no. 1 can be replaced with nineteen other amino acids. When one amino acid is replaced, 20 proteins are encompassed by sequence ID no. 1. Related to this idea is modification or conjugation of sequence ID no. 1 because the modification and conjugation are dependent on what amino acid is present at positions 1-10 of the sequence. Modification and conjugation can occur on a terminus or a side chain.
Number of Conservative or Non-conservative Substitutions
Number of Proteins Encompassed by Sequence ID no. 1
One
20
Two
20•20=400
Three
20•20•20=8000
Based on the information presented above, 20+420+8000=8440 different proteins are encompassed by a peptide comprising at least 70% sequence identity to a peptide of sequence ID no. 1.
(3) Physical and/or chemical properties and (4) Functional characteristics:
Proteins of the examined application are used in cancer immunotherapy (pages 17, paragraphs [0064]-[0066]).
(5) Method of making the claimed invention:
Method of making a wild-type or recombinant protein are described (page 35, paragraph [0126]).
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The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claim(s) 1-10 and 22 is/are broad and generic, with respect to all possible compounds encompassed by the claims. The possible structural variations are limitless to any sequence of sequence ID no. 1 in which up to three amino acids are replaced conservatively or non-conservatively. Although the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond those compounds specifically disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus. While having written description of sequences ID nos. 1-19 and compounds identified in the specification tables and/or examples, the specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-9 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 7-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: The method of modification or conjugation is unclear in these claims due to no recited guidance. Claim 7 does not state how a peptide is modified. Additionally the type of modification depends in what amino acid is present at positions 1-10 of sequence ID no. 1. Claims 8 and 9 are unclear because the method of conjugation is not clear, similar to modification in claim 7. The method of conjugation depends on what amino acid is present at positions 1-10 of sequence ID no. 1 and if the conjugation is done at a terminus of the protein or a side chain of the protein.
The metes and bounds of a major histocompatibility complex (MHC) polypeptide are unclear. Neither the specification or claims provide discrete metes and bounds with respect to what is considered a MHC polypeptide. HAMMER (Immunity, 2007, 26, 397-406) describes 9-mer peptides with the consensus motif X[P]XXXXXX[I,L,M] in which X is any amino acid (page 398, column 1, paragraph 1). Does applicant intend for these MHC polypeptides to be part of the molecular complex of claim 22?
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Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
Claim(s) 1-3 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Drmanac (WO 0175067, published 2001 October 11). Drmanac describes sequence ID no. 37300 (page 101, claim 20, alignment shown below), a 159 amino acid protein.
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Claim(s) 1-3 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DEUTZMANN (US 20180305776, published 2018 October 25). Deutzmann describes sequence 39, a 288 amino acid protein.
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Claim(s) 1, 2, 4, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BREMEL (US 20130330335, published 2013 December 12). Bremel describes sequence 583446 (page 54, table 14A).
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Allowable Subject Matter
Claims 1-10 and 22 are not allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699