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 .
Applicant’s amendment and remarks filed on 7/9/2026 are acknowledged. Claim 1 is amended. Claims 1-20 are pending.
Election/Restrictions
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-10 are currently under examination.
Objections Maintained
The use of the trademark HIS TAG has been noted in this application in multiple places. It should be capitalized wherever it appears and be accompanied by the generic terminology.
Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks.
It is noted that the cited occurrence of improper use is only exemplary and applicant should review the specification to correct any other use of trademarks.
Applicant’s amendment is noted. However, as set forth in MPEP 608.01(v), each letter of the mark must be capitalized. In addition, the mark must be accompanied by the generic terminology.
Claim Rejections Withdrawn
The rejection of claims 1-4, 8, and 10 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,072,054 is withdrawn in light of applicant’s amendment thereto.
The rejection of claims 1-4, 8, and 10 under 35 U.S.C. 102(a)(1) as being anticipated by Kalyanasundaram et al (US Patent 10,072,054, 2018; IDS filed 8/28/2023) is withdrawn in light of applicant’s amendment thereto.
Claim Rejections Maintained
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.
The rejection of claims 1-10 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 pre-AIA the applicant regards as the invention is maintained for the reasons set forth in the previous office action. Claims not specifically mentioned are included because they contain the issue of the parent claim.
Claim 1 is rendered indefinite by the recitation of the trademark His-tag. If a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product.
Applicant argues: That the claim has been amended to read “His-tag”.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons: The term is still a trademark, which renders the claim indefinite.
New Claim Rejections
35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-4, 6, and 8-10 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant has amended claim 1 to recite “a linker between two or more of said antigens, wherein the linker comprises a glycine and/or serine.” This phrase does not appear in the specification or original claims as filed. Applicant points to paragraph 0014 of the instant specification as support for this amendment. However, said paragraph does not provide support for the actual limitation in the claims. The specification mentions linkers that are composed of glycine or serine or a combination thereof as well as a “glycine/serine linker,” which is a peptide linker that is composed primarily of glycine and serine. Neither of these definitions is equivalent in scope to a linker that “comprises a glycine and/or serine”. Therefore, this limitation is new matter.
Conclusion
No claim is allowed.
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 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 Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN GANGLE/ Primary Examiner, Art Unit 1645
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