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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election with traverse of Group I, claims 9-14, 16, 18, 23, 25-31, 54-55 and species: SEQ ID NO: 2, albumin binding domain, SEQ ID NO: 18 in the reply filed 12/29/2025 is acknowledged. The traversal is on the ground(s) that there is not a serious burden to search the other nonelected groups together. This is not found persuasive because the other unelected groups, Groups II and III, are drawn to different statutory categories of invention and the provisions of 35 U.S.C. 121 indicate that the invention can be separated along the categories of invention. In regards to the argument that there is no search burden, there is a serious search burden because the inventions require a different field of search, for example employing different search queries to examine the products versus the methods claimed. Applicant elected the group pertaining to the product, which is under examination in the instant Office Action.
Claims 27-30, 56, and 64 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 12/29/2025.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 9, 11-13, 16, 18, 23, 25-26, 31, and 54-55 are now under consideration in the instant Office Action.
Withdrawn Objections
Objections to claims 9-14, 16, 18, 23, 25-26, 31, and 54-55 due to minor informalities are hereby withdrawn in view of amendments to the claims.
Withdrawn Rejections
Rejections of claims 14, 23, and 25-26 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paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter are hereby withdrawn in view of amendments to the claims and cancellation of claim 14.
Rejections of claims 9-14, 16, 18, 23, 25-26, 31, 54-55 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or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement are hereby withdrawn in view of amendments to the claims.
Rejections of claims 9-13, 16, 18, 31, and 54-55 under 35 U.S.C. 102(a)(1) as being anticipated by Geskin et al. 2015 (in instant PTO-892) are hereby withdrawn in view of amendments to the claims that altered the scope of the claims.
New Rejections Necessitated by Amendment
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 9, 11-13, 16, 18, 23, 25-26, 31, and 54-55 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.
Instant claim 9 recites “wherein the PD-1 targeting moiety is anti-PD-1 or a fragment thereof, wherein the anti-PD-1 or a fragment thereof comprises…” It is unclear what is encompassed by the “anti-PD-1”, e.g., if it is an antibody, antibody binding fragment, or a scFv. The claims thus far have only ascertained it to be a targeting moiety, and the recitation of “anti-PD-1” is incomplete phrasing. The dependent claims are also rejected because they fail to remedy this issue.
Claim 12 uses the transitional term “having the sequence”. This term is problematic because the recitation of these terms in instant claim 12 renders the claim unclear by what not defining what is encompassed by “having” the sequences. Applicant has not conveyed that they are in possession of all the antibodies that are included in the broad term “having the sequence”. It is not immediately clear whether open or closed claim language is intended, Crystal Semiconductor Corp. v. Trilech Microelectronics Int’l Inc., 246 F.3d 1336, 1348, 57 USPQ2d 1953, 1959 (Fed. Cir. 2001) (term “having” in transitional phrase "does not create a presumption that the body of the claim is open"); Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1573, 43 USPQ2d 1398, 1410 (Fed. Cir. 1997) (in the context of a cDNA having a sequence coding for human PI, the term “having” still permitted inclusion of other moieties), see MPEP 2111.03. Applicant is encouraged to use transitional phrases “comprising of” or “consisting of” to define the scope of a claim with respect to what unrecited additional components, if any, are excluded from the scope of the 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 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 SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
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, 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.
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.
/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
Prosecution Insights