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 .
2. Claims 1-16 are pending and under consideration for their full scope.
3. Applicant’s IDS documents filed on 06/27/2025 have been considered.
4. 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.
5. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19, 22-26, 30-31, 33 and 35-44 of copending Application No. 18/459,142 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 6-7 recite that the VH and VL comprise reference SEQ ID NOs 33 and 34 which comprise the CDRs of instant SEQ ID NOs 13, 15, 17, 19, 21 and 23.
The reference teachings anticipate the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
6. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27, 29 and 32-46 of copending Application No. 18/282,767(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 27 and 36 recites that the VH and VL comprise reference SEQ ID NOs 13 and 14 and heavy and light chains SEQ ID NOs 17 and 18 which comprise the CDRs of instant SEQ ID NOs 13, 15, 17, 19, 21 and 23.
The reference teachings anticipate the claimed invention.
7. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 120-147 of copending Application No. 18/703,249 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference claim 120-147 recites that the VH and VL comprise reference SEQ ID NOs 121 and 122 (and all of the additional recited sequences) which comprise the CDRs of instant SEQ ID NOs 13, 15, 17, 19, 21 and 23.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
8. 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.
9. Claims 1-16 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.
Claim 1 recites the term “a condition that would benefit from upregulation of immune response” and this term is unclear and indefinite.
The specification on pages 6-7 and 42 defines this term in the following ways:
[0032] In another aspect, the present disclosure provides methods of treating a condition in a subject that would benefit from upregulation of immune response, comprising administering an effective amount of the antibody or antigen-binding fragment thereof provided herein to the subject. In certain embodiments, the subject has upregulated expression of PD-L1.
[0033] Use of the antibody or antigen-binding fragment thereof provided herein in the manufacture of a medicament for treating a condition that would benefit from upregulation of immune response. In certain embodiments, the condition is cancer or chronic viral infection.
[00160] Therapeutic methods are also provided, comprising: administering a therapeutically effective amount of the antibody or antigen-binding fragment as provided herein to a subject in need thereof, thereby treating or preventing a condition or a disorder associated with related to PD-L1. In another aspect, methods are provided to treat a condition in a subject that would benefit from upregulation of immune response, comprising administering a therapeutically effective amount of the antibody or antigen-binding fragment as provided herein to a subject in need thereof.
The scope of this term cannot be ascertained from the disclosure in the specification. The specification’s disclosure on page 6 and the recitation of claim 2 which recites “wherein the subject has upregulated expression of PD-L1” makes the term especially indefinite by suggesting that a person with an upregulated expression of PD-L1 would be encompassed by a subject who would benefit from upregulation of immune response since they are already upregulated in an immune response. As such, the term is unclear and indefinite.
Correction is required.
10. 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.
11. Claims 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for: a methods of treating cancers associated with upregulated expression of PD-L1 using the anti-PD-L1 antibodies of claims 1-16, the specification does not reasonably provide enablement for: methods of treating “a condition in a subject that would benefit from upregulation of immune response” of claim 1; wherein the subject has upregulated expression of PD-L1 of claim 2 and as applied to claims 3-16.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and or use the invention commensurate in scope with the claims. The specification disclosure does not enable one skilled in the art to practice the invention without an undue amount of experimentation.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
The art of Rao et al. (PTO-892; Reference V) teaches that anti-PD-L1 antibodies induce type 1 diabetes, pneumonitis and gastrointestinal inflammation (In particular, right column, whole document). The art of Naidoo (PTO-892; Reference U) furthers this discussion on the toxicities caused by anti-PD-1 and anti-PD-L1 antibodies. Naidoo teaches that cases of myasthenia gravis have been reported in studies combining anti-PD-1/PD-L1 mAb with anti-CTLA-4 mAb and single-agent ipilimumab therapy was associated with a number of neurologic syndromes such as transverse myelitis, enteric neuropathy, aseptic meningitis, and Guillain–Barre syndrome. (In particular, pages 2386-2387, whole document). As such, the specification is not enabled for treatment of any condition “that would benefit from upregulation of immune response” as these conditions in the art would benefit from upregulation of any immune response and are not treated by anti-PD-L1 antibodies The specification is only enabled for treating cancers which are associated with upregulated expression of PD-L1. An anti-PD-L1 antibody would not benefit anyone who does not have a condition that the binding of PD-L1 would address.
The specification fails to provide guidance as to treat any condition that would benefit from upregulation of immune using any of the recited agents. It would require an undue amount of experimentation for one of ordinary skill in the art to practice the claimed invention commensurate in the scope with the claims. The invention may encompass methods which treat particular, specific diseases, but the specification does not disclose how to treat any condition that would benefit from upregulation of any immune response which reads on basically every disease.
Although, the specification describes in vitro experiments, there is no correlation on this record between the in vitro studies and the treating any condition that would benefit from upregulation of any immune response in currently available form for humans or animals. It is not enough to rely on in vitro studies where, as here, a person having ordinary skill in the art has no basis for perceiving those studies as constituting recognized screening procedures with clear relevance to efficacy in humans or animals (emphasis added). Ex parte Maas, 9 USPQ2d 1746
In view of the absence of a specific and detailed description in Applicant's specification of how to effectively use the genus of methods claimed, absence of working examples providing evidence which is reasonably predictive that the genus of methods that are effective for in vivo treatment of disease, and the lack of predictability in the art at the time the invention was made, an undue amount of experimentation would be required to practice the claimed antibodies with a reasonable expectation of success.
Substantiating evidence may be in the form of animal tests, which constitute recognizedscreening procedures with clear relevance to efficacy in humans. See Ex parte Krepelka, 231USPQ 746 (Board of Patent Appeals and Interferences 1986) and cases cited therein. Ex parteMaas, 9 USPQ2d 1746.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
12. No claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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June 27, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
Prosecution Insights