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
1. Claims 1,3,10-15,17,32,37,45,47-51 are pending.
2. Applicant’s election without traverse of Group I, claims 1,3,10-15,17,32,37,45,47-51 as they read on ABP comprising heavy and light chain CDRs from a clone 2H03 in the reply filed on10/20/25 is acknowledged.
It is noted that in the Restriction Requirement mailed on 06/18/25, the Examiner indicated that each clone is patentably distinct group not a species as indicated in Applicant’s response filed on 10/20/25.
Claims 1,3,10-15,17,32,37,45,47-51 as they read on ABP comprising heavy and light chain CDRs from a clone 2H03 are under consideration in the instant application.
3. Claims 1,3,10-15,17,32,37,45,47-51 are objected because they do not correspond to the scope of the elected Group I, as they read only on heavy and light chain CDRs from a clone 2H03 .
Appropriate correction is required.
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.
4. 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.
5. 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.
6. Claims 1,3,10-15,17,32,37,45,47-51 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
7. Claims 1,3,10-15,17,32,37,45,47-51 are indefinite in the recitation of “clone 2H03” because its characteristics are not known. The use of " clone 2H03" as the sole means of identifying the claimed isolated ABP renders the claim indefinite because clone 2H03" is merely a laboratory designation which does not clearly define the claimed product, since different laboratories may use the same laboratory designation s to define completely distinct ABP.
Applicant should amen the claims to recited a specific SEQ ID NOs for HCDRs and LCDRs for said clone 2H03 as recited in Table 10 of the instant Specification.
8. Claim 3 indefinite in the recitation of “the isolated ABP of claim 0” because its characteristics are not known. There is no claim 0 in the instant pending claims.
Appropriate correction is required.
9. Claim 51 indefinite in the recitation of “modification that alters an affinity of ABP” because its characteristics are not known. The Specification provided no teaching or definition of what modification Applicant considered to alters an affinity of ABP.
Appropriate correction is required.
10. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
11. The claims 1,3,10-15,17,32,37,45,47-51 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Applications:
US 20240279343 A1
US 20240059797 A1
US 20230295305 A1
US 20250353914 A1
US 20230287128 A1
US 20230041030 A1
US 20220213196 A1
US 20220162320 A1
US 20210147550 A1
US 20210061914 A1
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims of copending Applications:
US 20240279343 A1
US 20240059797 A1
US 20230295305 A1
US 20250353914 A1
US 20230287128 A1
US 20230041030 A1
US 20220213196 A1
US 20220162320 A1
US 20210147550 A1
US 20210061914 A1
Each recited an isolated ABP that specifically binds to HLA-Peptide.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
12. No claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel Kolker can be reached on 571/ 272-3181
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644