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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission of RCE on 3/31/25 and the amendment of claims has been entered.
Election/Restrictions
Applicant’s election without traverse of Group 2, claimed in claims 12 and 14 in the reply filed on 3/19/24 was previously acknowledged. Election was made of the protein and SEQ ID NO: 6.
In the reply filed 7/5/24, Applicants canceled claims 1-9, 13 and 15. Claims 16-18 were added. Claim 12 was amended.
In the reply filed 3/31/25, Applicants amended claim 12 and canceled claims 16-17. Claims 19-20 were added.
Claims 12, 14 and 18-20 are pending.
Claims 12, 14 and 18-20 are under consideration.
Claim Rejections-Withdrawn
The rejection of claims 12, 14 and 17 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn due to amendment of the claim.
The rejection of claims 12, 14 and 16-18 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn due to amendment of the claims.
Response to Arguments
Applicant’s arguments with respect to rejections above have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections-NEW
Claim 12 is objected to because of the following informalities: “a therapeutically effective amount of a peptide selected from the group consisting of a peptide comprising the amino acid sequence…” should be corrected to “a therapeutically effective amount of a peptide selected from the group consisting of SEQ ID NO: 6…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102-NEW
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.
Claims 12, 14 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arnoux et al. (“Peptidyl arginine deiminase immunization induces anticitrullinated protein antibodies in mice with particular MHC types” PNAS published online Nov. 6, 2017 E10169-E10177) as evidenced by NCBI Reference Sequence: NP_036519.2 (2025) and GenBank: AAF82265.1 (May 2001).
Claim 12 is drawn to a peptide selected from the group consisting of a peptide comprising the amino acid sequence of SEQ ID NO: 6 or SEQ ID NO: 7 or a nucleic acid sequence encoding the peptide. Please note that the transitional phrase “comprising” is interpreted as open. MPEP 2111.03 states the transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Because the instant specification fails to provide a limiting definition of the phrase “comprising”, the broadest reasonable interpretation of claim 12 includes sequences in which SEQ ID NO: 6 and 7 are embedded and does not exclude additional, unrecited elements.
Arnoux et al. teach autoantibodies to citrullinated proteins (ACPAs) are present in two thirds of patients with RA. Arnoux et al. teach PAD4 is the target of autoantibodies in early RA (Abstract). Arnoux et al. teach C3H mice were immunized with murine or human PAD4 in Freund’s complete adjuvant (p. 1, 2nd col.). As evidenced by NCBI Reference Sequence, human PAD4 comprises instantly claimed SEQ ID NO: 7 (residues 71-90). As evidenced by GenBank: AAF82265.1 (May 2001), human PAD4 comprises SEQ ID NO: 6 (residues 71-90). Please note that MPEP 2131.01 states: that an extra reference or evidence can be used to show an inherent characteristic of the thing taught by the primary reference. In the instant case, the evidentiary references are relied upon only to establish that SEQ ID NO: 6 and 7 are embedded in human PAD4.
As indicated above, the open language of the claim includes sequences in which SEQ ID NO: 6 and 7 are embedded. The instant specification defines “subject” to include a mammal such as rodent [PGPUB0047]. The instant specification defines a “subject in need” is a subject with HLA-DRB1*04:01 [0048]. Arnoux et al. teach the C3H mice comprise the IEβK chain is highly homologous to the β1 chain HLA-DRB1*04:01 (Abstract), meeting the limitation of subject in need thereof.
Arnoux et al. does not teach inducing tolerance to PAD4 in a subject in need thereof however, administering a composition comprising an effective amount of SEQ ID NO: 7 or 8 from Arnoux et al. would inherently have all of the activities and properties of the composition of claim 12. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same…[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzqerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,433- 34 (CCPA 1977)).” In other words, Arnoux et al. teach administering the same composition (comprising SEQ ID NO: 7 or 8) to the same patient population, therefore tolerance to PAD4 would inherently be induced. Moreover, MPEP 2112.01 states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
With respect to claims 14 and 20, the instant specification and claims do not limit a “vaccine” to include specific components. The broadest reasonable interpretation of “vaccine” includes PAD4 with an adjuvant. Importantly, Arnoux et al. teach C3H mice were immunized with murine or human PAD4 in Freund’s complete adjuvant (p. 1, 2nd col.) indicating a vaccine was administered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
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.
Claims 12, 14 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Arnoux et al. (“Peptidyl arginine deiminase immunization induces anticitrullinated protein antibodies in mice with particular MHC types” PNAS published online Nov. 6, 2017 E10169-E10177) as evidenced by NCBI Reference Sequence: NP_036519.2 (2025) and GenBank: AAF82265.1 (May 2001).
The teachings of Arnoux et al. are presented above in detail. Arnoux et al. do not teach the subject has RA. However, the teachings of Arnoux et al. is suggestive of the limitation.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to administer PAD4 comprising SEQ ID NO: 6 and 7 to a subject with RA because Arnoux et al. teach administration to a model of RA. There is a reasonable expectation of success given that Arnoux et al. teach the method of administering PAD4 (comprising SEQ ID NO: 6 and 7) to a mouse.
Response to Amendment
The Declaration under 37 CFR 1.132 filed 3/31/25 is insufficient to overcome the rejection of the claims. In particular, the claims are drawn to open language and the broadest reasonable interpretation of the claims includes administering PAD4. Therefore, the data presented in the specification and Affidavit are not commensurate in scope with the claims. Please see MPEP 2145. However, the data is convincing regarding a peptide consisting of SEQ ID NO: 6 or 7.
Allowable Subject Matter
Claim 18 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim 18 is free of the prior art. There is no prior art found that teaches or suggests administered SEQ ID NO: 6 or 7 for inducing tolerance to PAD4 in a subject in need thereof. The closest art is Arnoux et al. (presented above), however Arnoux et al. does not teach administering a peptide consisting of SEQ ID NO: 6 or 7.
Conclusion
Claims 12, 14 and 19-20 are rejected.
Claim 18 is objected to.
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/TARA L MARTINEZ/Examiner, Art Unit 1654