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
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/23/2026 has been entered.
Status of the Claims
2. Claims 1-6 are the original claims filed 4/30/2020. In the Response of 10/12/2020, Claim 1 is amended. In the Reply filed 4/6/2021, Claims 3 and 6 are amended, claims 1-2 and 4-5 are canceled, and new claims 7-8 are added. In the Response of 10/21/2021, Claim 3 is amended and new Claims 9-32 are added. In the Response of 12/12/2022, Claim 23 is amended and Claims 17-22 are canceled. In the Response of 7/18/2023, Claims 3 and 11 are amended and claims 9-10, 13 and 15 are canceled. In the Response of 11/3/2023, Claim 23 is amended and claims 30 and 32 are canceled. In the Response of 3/24/2024, Claims 3, 11 and 23 are amended and claims 14, 16, 29 and 31 are canceled. In the Response of 10/8/2025, claims 3, 11 and 23 are amended. In the Response of 1/23/2026, Claims 3, 11, 23-25, and 27-28 are amended.
Claims 3, 6-8, 11-12, and 23-28 are pending.
Applicants’ amendment of the claims raises new grounds for rejection.
Priority
3. USAN 16/863,948, filed 04/30/2020, and having 4 RCE-type filing therein, is a Continuation of PCT/US2019/057741, filed 10/23/2019, PCT/US2019/057741 Claims Priority from Provisional Application 62/807,363, filed 02/19/2019, PCT/US2019/ 057741 Claims Priority from Provisional Application 62/773,839, filed 11/30/2018, PCT/US2019/057741 Claims Priority from Provisional Application 62/749,662, filed 10/23/2018.
Information Disclosure Statement
4. As of 2/24/2026, a total of eight (8) IDS are filed: 10/12/2020; 12/12/2022; 7/18/2023; 11/3/2023; 2/5/2024; 3/24/2025; 10/8/2025; and 1/23/2026. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Objections
Claim Objections
5. The objection to Claims 23-28 because of informalities is withdrawn.
a) Applicants explanation that a “degradant” is an actual specific product renders the objection moot.
b) Claims 24-25 and 27-28 are amended to recite “the thermal stress.”
Withdrawal of Rejections
Double Patenting
6. The provisional rejection of Claims 3, 8, and 11 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 19/044,292 (reference application) is moot and withdrawn in view of the abandonment of the application effective as of 1/5/2026.
Claim Rejections - 35 USC § 103
7. The rejection of Claim(s) 3, 6-8, 11-12, and 23-28 under 35 U.S.C. 103 as being unpatentable over Chugai Seiyaku Kabushiki Kaisha (USPN 11066483; US 20220041756; US 20240294672; and US 20240262933 (PTO 892 4/8/2025)) in view of Lo et al (J Biol Chem 2017 Mar 3;292(9):3900-3908. doi: 10.1074/ jbc. M116. 767749. Epub 2017 Jan 11) is withdrawn.
Applicants arguments and the comparative data in Figures 8 and 9 showing “unexpected stability” for the claimed IgG comprising substitutions L234A, L235A, D265C and H435A is found persuasive.
Rejections Maintained
Double Patenting
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.
8. The rejection of Claims 3, 8, and 11 on the ground of nonstatutory double patenting as being unpatentable over claims 21-22 of U.S. Patent No. 10882915 is maintained.
Applicants allege support for the amendments to claims 3, 11, and 23 can be found, for example, at page 20, lines 28-30 of the specification. Applicants allege claims 3, 8, and 11, as amended, are directed to an IgG antibody, or an antigen-binding portion thereof, that specifically binds CD45. The claims of the '915 patent are directed to an isolated anti-CD 117 antibody, or antigen-binding fragment thereof.
Response to Arguments
Applicants citation of alleged support in the original specification as filed does not correspond to the exact limitation cited in the claims. For example, page 20, lines 28-30 from the original specification as filed teaches nothing having to do with the amendment of claims 3, 8 and 11 to recite the CD45 antigen:
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Applicants do not identify original written description support for the amended claims as required under 37 CFR 1.121 and MPEP 714.03, where amendments to claims in US applications require an explanation in the original disclosure for the changes made.
9. The provisional rejection of Claims 3, 8, and 11 on the ground of nonstatutory double patenting as being unpatentable over claims 37-38 of copending Application No. 17/507,456 (reference application US 20220175946) is maintained.
Applicants allege “As described in Patent Center, claims 37 and 38 of the '456 application are canceled.”
Response to Arguments
Neither claims 37 and 38 from the most recent claim set of 10/14/2025 for the '456 application is canceled:
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New Grounds for Rejection
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.
10. Claims 23-28 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.
Claims 23-28 are indefinite as being incomplete for the claimed subject matter. Claim 23 does not properly conclude in the identification of the subject matter to which the IgG antibody binds. The POSA cannot reasonably ascertain the metes and bounds of the claimed invention. MPEP 2173.02.
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.
Written Description
11. Claims 3, 6-8, 11-12, and 23-28 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.
Claims 3, 6-8, 11-12 are drawn to a CD45 binding IgG antibody.
Claims 23-28 do not recite the antigen to which the IgG antibody binds. Assume, arguendo, claims 23-28 are drawn to a CD45 binding IgG antibody.
Applicants citation of alleged support in the original specification as filed does not correspond to the exact limitation cited in the claims. For example, page 20, lines 28-30 from the original specification as filed teaches nothing having to do with the amendment of claims 3, 8 and 11 to recite the CD45 antigen:
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Applicants do not identify original written description support for the amended claims as required under 37 CFR 1.121 and MPEP 714.03, where amendments to claims in US applications require an explanation in the original disclosure for the changes made.
Conclusion
12. No claims are allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM. 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, Wu Julie can be reached on 571-272-5205. 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.
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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