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 .
RESPONSE TO AMENDMENT
The substitute specification and claim amendments filed 7-10-2026 have been entered into the record. Claims 1-10, 16-45 and 53 have been cancelled. Claims11-15 and 46-52 are pending. Claims 11-15and 46-51 are under examination. Claim 52 remains withdrawn from consideration.
The text of Title 35 of the U.S. Code not reiterated herein can be found in the previous office action.
Objections/Rejections Withdrawn
The objections to the disclosure are withdrawn in view of Applicant’s amendments thereto.
The objection to claim 11 is withdrawn in view of the amendment to the claim.
The rejection of claims 11, 13 and 48-51 on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,286,283 and US Patent 11,819,544 are withdrawn in view of the amendment to the claims.
The rejection of claims 11-15 and 45-51 under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement in the Office Action mailed 1-28-2026 is withdrawn in view of the amendment to the claims and new grounds of rejection set forth below.
The rejection of claims 11-15 and 47-51 under 35 U.S.C. 102(a)1 and 102(a)(2) as being clearly anticipated by Braun et al (WO 2019/121924) is withdrawn in view of the amendment to the claims.
The rejection of claims 11-15 and 47-51 under 35 U.S.C. 102(a)1 and 102(a)(2) as being clearly anticipated by Faridmoayer et al (WO 2019/121926) is withdrawn in view of the amendment to the claims.
New Rejections Based on Amendment
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.
Claims 11-15 and 47-51 are rejected 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. The claim(s) contains 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.
The claims are drawn to a sequence followed by “(SE ID NO:19)”. As such, the claims state that the consensus sequence is represented by SEQ ID NO:19, however SEQ ID NO:19 as described in the specification and in the sequence, listing is at page 4, lines 14-19 state:
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This is in contrast to the claims that redefine Z1 and Z2 as any independent amino acid. As such the claims are in conflict with the definition of SEQ ID NO:19.
As such, the claims are drawn to new matter as they recited a “Z” which is in contrast to the defined SEQ ID NO:19 in the specification and sequence listing.
Claim Rejections - 35 USC § 112
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 11-15 and 47-51 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.
As to claim 11 and every claim dependent thereon, the claims state that the consensus sequence is represented by SEQ ID NO:19, however SEQ ID NO:19 as described in the specification and in the sequence listing as having “Z” positions as specifically limited rendering the scope of the recited consensus sequence claim insolubly indefinite.
As to claim 51, the claim recites the composition of 50 and a” pharmaceutically acceptable excipient or carrier” that lacks clear antecedent basis in claim 50. Applicant may consider amending the claim to recite wherein the diluent is a pharmaceutically acceptable excipient or carrier” to obviate this rejection.
Status of Claims
Claims 11-15 and 47-51 stand rejected. Claim 52 remains withdrawn from consideration.
Claim 46 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 8:00 am - 4 pm.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
