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 .
Claim Status
Claim listing filed on May 13, 2026 is pending. Claims 3, 6, 11, 16-18, 20-24, 27, 29-30, 32-34, 36, and 38 are canceled. Claims 1-2, 4-5, 7-8, 10, 13, 26, 28, 35, and 39 are amended. Claims 14-15, 19, 31, 35, 37, and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions or species. Claims 1-2, 4-5, 7-10, 12-13, 25-26, and 28 are examined upon their merits.
Information Disclosure Statement
The information disclosure statement filed on 05/13/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Withdrawn Objections and Rejections
Applicant’s amendments to the specification have overcome the objections pertaining to the title, Figures 1-37, and hyperlinks. As such, those specification objections are withdrawn.
Applicant’s amendments to the claims overcome all claim objections of record directed to Claims 13 and 26, and the claim objections are withdrawn.
The rejection of Claims 1-2, 4-5, 7-10, 13, 25-26, and 28 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of Applicant’s amendments to the claims. Specifically, the indefinite terms “a variant thereof,” “an immunogenic fragment,” and “derivatives thereof” have been deleted.
The provisional rejection of Claims 4-5 and 7-8 on the ground of nonstatutory obvious-type double patenting as being unpatentable over claims 1-2, 4, and 9-10 of copending U.S. App. No. 18/046,670 in view of Shahbazi et al. J Med Microbiol Infec Dis 2016 is withdrawn in view of Applicant’s remarks filed 05/13/2026. It is persuasive that the copending claims do not teach or suggest the specific N-terminus to C-terminus order of antigenic polypeptides required by Claims 4-5 and 7-8.
The provisional rejection of Claims 1-2, 4-5, 7-8, 13, 25-26, and 28 on the ground of nonstatutory double patenting as being unpatentable over claims 77, 81, 83-84, and 93-97 of copending U.S. App. No. 19/062,913 is withdrawn in view of Applicant’s amendments to the claims. Specifically, the copending claims do not teach a fusion protein comprising at least 95% identity to SEQ ID NOs: 6, 7, and 8 or a fusion protein comprising fragments comprising 8 to 9 amino acids of SEQ ID NOs: 6, 7, and 8 as required by amended Claim 1.
Specification (Maintained)
The disclosure is objected to because of the following informalities:
Table 10 on page 69 should be labeled “Table 7.”
Appropriate correction is required.
Applicant's arguments filed May 13, 2026 have been fully considered but they are not persuasive. Applicant says that “Table 10” has been amended to “Table 7” on page 69; however, the specification filed on 05/13/2026 still recites “Table 10” on page 69.
Claim Objections (New, necessitated by amendment)
The non-final office action filed 01/13/2026 withdrew Claims 14-15, 19, 31, 35, 37, and 39 from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions or species. MPEP 714.II.C states: “For any amendment being filed in response to a restriction or election of species requirement and any subsequent amendment, any claims which are non-elected must have the status identifier (withdrawn). Any non-elected claims which are being amended must have either the status identifier (withdrawn) or (withdrawn – currently amended) and the text of the non-elected claims must be presented with markings to indicate the changes.” Claims 14-15, 19, 31, 35, 37, and 39 are not labeled as “(withdrawn)” or “(withdrawn – currently amended).” Appropriate correction is required.
Claim Rejections - 35 USC § 112 (Maintained)
The rejection of Claims 1-2, 4-5, 7-10, 13, 25-26, and 28 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is maintained. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-2, 4-5, 7-10, 13, 25-26, and 28 are directed to a fusion protein comprising 6-8 antigenic polypeptides wherein the antigenic polypeptides can comprise (1) an amino acid sequence at least 95% identical to the amino acid sequence of SEQ ID NOs: 1, 2, 3, 4, 5, 6, 7, and/or 8 or (2) a fragment comprising at least 8 or 9 amino acids of SEQ ID NOs: 1, 2, 3, 4, 5, 6, 7, and/or 8. Note, “a fragment comprising at least 9 amino acids of SEQ ID NO: X” and “a fragment comprising at least 8 amino acids of SEQ ID NO: X” are interpreted wherein the fragment comprises at least 8 or at least 9 consecutive amino acids from the recited sequences. For example, in the amino acid sequence MWNFFRRELTS, “a fragment comprising at least 9 amino acids” could comprise MWNFFRREL, WNFFRRELT, NFFRRELTS, MWNFFRRELT, MWNFFRRELTS, etc.
The amended claims are still directed to a genus of fusion proteins comprising antigenic polypeptides with substantial structural variation. Considering just the variation in the antigenic polypeptide of SEQ ID NO: 1, 5% variation in sequence identity means that any combination of 7 amino acids can be added, deleted, or substituted with any other amino acid residue (5% of 148 amino acid residues). Therefore, an amino acid sequence at least 95% identical to SEQ ID NO: 1 encompasses thousands of amino acid sequence possibilities. Similarly, considering that SEQ ID NO: 1 comprises 148 amino acid residues, a fragment comprising at least 9 amino acids of SEQ ID NO: 1 also encompasses thousands of amino acid sequence possibilities. Because each of the recited antigenic polypeptides comprises this structural variation, the genus of fusion proteins comprising 6-8 antigenic polypeptides has substantial structural variation (potentially millions of fusion proteins with unique amino acid sequences). The instant specification lacks proper written description for the genus of fusion proteins claimed for the reasons of record in the non-final office action filed 01/13/2026.
Applicant's arguments filed May 13, 2026 have been fully considered but they are not persuasive. Applicant argues that because the amended claims remove reference to the phrases “variant thereof” and “immunogenic fragment,” the claims meet the written description requirement. The phrases “variant thereof” and “immunogenic fragment” were replaced with the phrases “at least 95% identical to the amino acid sequence of SEQ ID NO: X” and “a fragment comprising at least 8 or 9 amino acids of SEQ ID NO: X” which encompass substantial structural variation for the reasons outlined above. Therefore, the claims still lack proper written description for the genus of fusion proteins claimed, and the rejection is maintained.
The rejection of Claims 1-2, 4-5, 7-10, 13, 25-26, and 28 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is maintained because the specification, while being enabling for a fusion protein comprising antigenic polypeptides comprising SEQ ID NOs: 1-2, 4, and 6-8 (Claim 1), a fusion protein further comprising antigenic polypeptides comprising SEQ ID NOs: 3 and/or 5 (Claim 2), and fusion proteins comprising SEQ ID NOs: 76, 77, 78, or 79 (Claim 12); does not reasonably provide enablement for the genus of fusion proteins comprising antigenic polypeptides comprising at least 95% identity to various sequences or fragments comprising at least 8 to 9 amino acids of various sequences (Claims 1-2, 4-5, 7-10, 13, 25-26, and 28). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Because the amended claims recite “at least 95% identical to the amino acid sequence of SEQ ID NO: X” and “a fragment comprising at least 8 or 9 amino acids of SEQ ID NO: X,” the claims are still directed to a genus of fusion proteins comprising antigenic polypeptides with substantial structural variation (see above written description rejection). The instant specification lacks proper enablement for the genus of fusion proteins claimed for the reasons of record in the non-final office action filed 01/13/2026.
Applicant's arguments filed May 13, 2026 have been fully considered but they are not persuasive. Applicant argues that because the amended claims remove reference to the phrases “variant thereof” and “immunogenic fragment,” the instant specification enables the invention to make and use the claimed subject matter. The phrases “variant thereof” and “immunogenic fragment” were replaced with the phrases “at least 95% identical to the amino acid sequence of SEQ ID NO: X” and “a fragment comprising at least 8 or 9 amino acids of SEQ ID NO: X” which encompass substantial structural variation for the reasons outlined above. Given that structure is essential to function, a person having ordinary skill in the art would have to perform further experimentation to make fusion proteins comprising a representative number of antigenic polypeptides comprising the recited sequence identities and fragments, then screen the fusion proteins’ characteristics in order to practice the invention commensurate with the scope of the claims. Therefore, there is a lack of proper enablement for the genus of fusion proteins claimed, and the rejection is maintained.
Double Patenting (Maintained)
1. The provisional rejection of Claims 1-2, 9-10, 25-26, and 28 on the ground of nonstatutory obvious-type double patenting as being unpatentable over claims 1-2, 4, and 9-10 of copending U.S. App. No. 18/046,670 (of record) in view of Shahbazi et al. J Med Microbiol Infec Dis 2016 (of record) is maintained.
Applicant's arguments filed May 13, 2026 have been fully considered but they are not persuasive. Applicant argues that the copending claims do not teach or suggest the specific N-terminus to C-terminus order of antigenic polypeptides required by Claims 1-2, 9-10, 25-26, and 28. However, Claims 1-2, 9-10, 25-26, and 28 do not require a specific N-terminus to C-terminus order, and the broadest reasonable interpretation is that the fusion protein can comprise the antigenic polypeptides in any order. Therefore, the instant claims are either anticipated and/or rendered obvious by the copending claims in view of Shahbazi, and the provisional rejection is maintained.
Allowable Subject Matter
Claim 12 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. Further, a fusion protein comprising SEQ ID NOs: 1-2, 4, and 6-8 is free of the prior art.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection and/or objection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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