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
In the amendment filed on 03/27/2026 Applicant canceled claim 86, amended claims 1, 19, 41, 60, 62, 80, 84, 99, and 110 and added the new claims 130-132. Claims 1-3, 8, 14, 16-19, 29, 41, 60, 62, 80, 84, 89, 93, 99, 110, 111, 114, 122, 124, 125 and 127-132 are pending in the application. Claims 114, 122, 124, 125, 127, and 128 are withdrawn from consideration. Claims 1-3, 8, 14, 16-19, 29, 41, 60, 62, 80, 84, 89, 93, 99, 110, 111 and 129-132 are examined.
Withdrawn claim objections/rejections
Claim Objections
The objection to claim 19 is withdrawn in view of the amendment to the claim.
Claim Rejections - 35 USC § 112
The rejection of claim 1 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of the amendment to the claim.
Claim Rejections - 35 USC § 102
The rejection of claims 1-3, 8, 14, 16-19, 29, 41, 60, 62, 89, 93, 99, 111 and 129 under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. is withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 103
The rejection of claims 80 and 86 under 35 U.S.C. 103 as being unpatentable over Li et al. in view of Borza et al. is withdrawn in view of the amendments to the claims.
New and maintained claim rejections necessitated by amendment
Claim Objections
Claim 132 is objected to because of the following informalities: each amino acid sequence needs to be indicated by a SEQ ID NO:. Appropriate correction is required.
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.
Claims 1-3, 8, 14, 16-19, 29, 41, 60, 62, 80, 84, 86, 89, 93, 99, 111 and 129 remain and claims 130-132 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 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 inventors, at the time the application was filed, had possession of the claimed invention for reasons of record.
On page 13 of the Remarks , Applicant argues that: “… the claimed invention, while as a combination novel and nonobvious, utilizes some classes of elements that are individually known ( e.g., cytokine polypeptide sequences, inhibitory polypeptide sequences, linkers ( comprising protease-cleavable peptide sequences), and pharmacokinetic modulators). Because these are known classes of elements, under Hersch/er and Capon, it is sufficient for the application to lead one having ordinary skill in the art to those classes. See Hersch/er, 591 F.2d at 702.”
The arguments were carefully considered but not found persuasive because, as indicated in the previous Office action, the issue is that, in the most conservative hypothesis (~200 cytokines, 48 types of protease activatable linkers and 482 sequences for targeting sequences - SEQ ID NOs: 180-662) the number of compounds comprising each of them is enormous (>5.5 millions). The specification discloses a number of 49 sequences of constructs (SEQ ID NOs: 803-852). This number clearly is not a representative number of species for the genus claimed; even considering, as per claim 93, two species for the cytokine IL-2, the number of combination is still very large (47,000) and thus the 49 sequences disclosed is not representative. The instant disclosure, including the claims fail to disclose a representative number of species falling with the scope of the genus or structural common to the members of the genus so the one of skill in the art can visualize or recognize the member of the genus. One of skill in the art would conclude that the specification fails to disclose a representative number of species to describe the claimed genera.
Allowable Subject Matter
Claim 110 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
No claims are allowed.
Claims 1-3, 8, 14, 16-19, 29, 41, 60, 62, 80, 84, 86, 89, 93, 99, 111 and 129-132 are not allowed. Claim 110 is objected to but would be allowable if rewritten in independent form.
THIS ACTION IS MADE FINAL. 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 ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
Prosecution Insights