: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 .
Information Disclosure Statement
The information disclosure statements (IDS) filed 09/28/2023, 01/17/2025, and 01/07/2026 have been considered and the references therein are of record.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. 2018 (WO2018137598-A1) and in further view of Boghaert et al. 2006 (WO2006031653-A2), Hilschmann et al. 1967, and Biddlecombie et al. 2019 (WO2019206987-A1) (see instant PTO-892).
Instant claims 1-12 and 14-15 are drawn to a composition of an anti-CD73 antibody and a method of using the composition to treat cancer. The antibody comprises a heavy chain variable region (VH) comprising a CDR1, a CDR2 and a CDR3, and a light chain variable region (VL) comprising a CDR1, a CDR2 and a CDR3. The antibody also comprises a heavy chain containing VH and a human gamma 1 constant domain, as well as a light chain containing VL and a human kappa constant domain.
Wang teaches an anti-CD73 antibody with identical sequences to instant SEQ ID NOs: 1-8 and a method of treating cancer in a patient, where the cancer is bladder cancer (para [0003]-[0009], [0013]-[0019]) as required in instant claims 1, 8, and 14-15. Wang teaches an antibody with a VH with an identical sequence to instant SEQ ID NO: 7, which encompasses SEQ ID NOs: 1-3 and the VH domain within SEQ ID NO: 9. Wang teaches the antibody is an isotype of IgG (claim 5). The alignment data between Wang SEQ ID NO: 7 and instant SEQ ID NO: 7 is shown below.
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Wang teaches an antibody with a light chain variable region (VL) with an identical sequence to instant SEQ ID NO: 8, which encompasses SEQ ID NOs: 4-6 and the VL domain within SEQ ID NO: 10. The alignment data between Wang SEQ ID NO: 8 and instant SEQ ID NO: 8 is shown below.
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Wang does not teach the entirety of SEQ ID NOs: 9 and 10. Further, Wang does not teach the human immunoglobulin heavy constant gamma 1 and human kappa constant domains within SEQ ID NOs: 9 and 10, respectively. Wang does not teach the composition of the anti-CD73 antibody formulation beyond the sequences.
Boghaert teaches an immunoglobulin heavy constant gamma 1 domain with identical sequence to the immunoglobulin heavy constant gamma 1 domain within SEQ ID NO: 9. The alignment data between the immunoglobulin heavy constant gamma 1 domains of Boghaert SEQ ID NO: 89 and instant SEQ ID NO: 9 is shown below.
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Hilschmann teaches a kappa constant domain with identical sequence to the kappa constant domain within instant SEQ ID NO: 10. The alignment data between the kappa constant domains of Hilschmann and instant SEQ ID NO: 10 is shown below.
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Biddlecombie teaches an antibody formulation comprising 50mg/ml of a human anti-PD-L1 antibody, 25 mM histidine/histidine-HCl buffer, 275mM trehalose dehydrate (11.4% (w/v) trehalose dehydrate), 0.02% (w/v) polysorbate 80, and a pH of 6.0. Biddlecombie also discloses that the formulation is a liquid formulation, a frozen formulation, a lyophilized formulation, or a reconstituted formulation and that the antibody formulation maintains stability at least three freeze/thaw cycles (see claims 1, 3-7, 12-17, 20, & 25).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosure of Wang in view of Boghaert and Hilschmann. One with ordinary skill in the art would be motivated to make and use the claimed invention because Wang teaches the variable domains of the anti-CD73 antibody treats cancer and is an IgG isotype, but only specifies the variable domains and not the constant domains that are necessary to make an IgG isotype antibody. The constant domain is consistent in antibodies of the IgG isotype, using the gamma and kappa constant domains in their heavy and light chains, respectively. An ordinary artisan would have found it obvious to combine the variable domains of Wang with the gamma and kappa constant domains of Boghaert and Hilschmann to make an IgG isotype of the heavy and light chains of the anti-CD73 antibody, respectively, since the constant domains are consistent in IgG isotype antibodies. An ordinary artisan would have been motivated to do this in order to synthesize an antibody that treats cancer. The person of ordinary skill in the art would have had a reasonable expectation of success based on the disclosures of these prior art references.
Furthermore, it would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosures of Wang, Boghaert, and Hilschmann in view of Biddlecombie. One with ordinary skill in the art would be motivated to make and use the claimed invention because Biddlecombie teaches that the disclosed antibody formulation improved stability of anti-PD1 antibody (page 1, lines 27-30; Fig 4). An ordinary artisan would have found it obvious to use the formulation as disclosed by Biddlecombie to improve the stability of the anti-CD73 antibody. An ordinary artisan would have been motivated to do this in order to make a stable antibody composition that treats cancer. The person of ordinary skill in the art would have had a reasonable expectation of success based on the disclosures of these prior art references.
In regards to claim 6, the prior art only differs from the claimed invention with respect to the concentration of trehalose dehydrate. The Court has stated that generally such differences amount to mere optimization and will not support patentability unless there is evidence indicating the claimed feature is critical. MPEP 2144 sets forth Applicant' s burden for rebuttal of a prima facie case of obviousness based upon routine optimization. Applicant must provide either a showing that the particular amount or range recited within the claims is critical; and/or a showing that the prior art reference teaches away from the claimed amount. In the instant case, the specification as filed provides no evidence that the particular amount or range recited within the claims is critical because the specification states that effective embodiments of the claimed invention have a trehalose concentration ranging from 2-20% (para [0018]), which is evidence of its lack of criticality.
Therefore, claims 1-12 and 14-15 are obvious in view of the disclosures of Wang, Boghaert, Hilschmann, and Biddlecombie.
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.
Claims 1, 8-9, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 10-14 of U.S. Patent No. 10584169B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims recite a composition of an anti-CD73 antibody and a method of using the composition to treat cancer, comprising SEQ ID NOs: 1-10.
The patented claims recite a method of treating cancer by administering an anti-CD73 antibody, comprising SEQ ID NOs: 1-24.
Instant SEQ NOs: 1-8 have identical sequences to patented SEQ ID NOs: 1-8. Patented claim 10 recites peptides having at least 90% sequence identity to patented SEQ ID NOs: 7 and 9-13, which encompass instant SEQ ID NO: 7. Patented claim 12 recites peptides having at least 90% sequence identity to patented SEQ ID NOs: 8, 15-20, and 22-24, which encompass instant SEQ ID NO: 8. Both instant claim 15 and patented claim 2 recites treating cancer where the cancer is selected from the group consisting of bladder cancer, breast cancer, colorectal cancer, endometrial cancer, esophageal cancer, head and neck cancer, kidney cancer, leukemia, liver cancer, lung cancer, lymphoma, melanoma, pancreatic cancer, prostate cancer, and thyroid cancer. Therefore, the patented claims anticipate and/or encompass the instant claims. Therefore, claims 1, 8-9, 15 are rejected as being unpatentable over U.S. Patent No. 10584169B2.
Claims 1 and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 10-14 of U.S. Patent No. 11613577B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims recite a composition of an anti-CD73 antibody, comprising SEQ ID NOs: 1-10.
The patented claims recite a composition of an anti-CD73 antibody, comprising SEQ ID NOs: 1-24.
Instant SEQ NOs: 1-8 have identical sequences to patented SEQ ID NO: 1-8. Patented claim 10 recites peptides having at least 90% sequence identity to patented SEQ ID NOs: 7 and 9-13, which encompass instant SEQ ID NO: 7. Patented claim 12 recites peptides having at least 90% sequence identity to patented SEQ ID NOs: 8, 15-20, and 22-24, which encompass instant SEQ ID NO: 8. Therefore, the patented claims anticipate and/or encompass the instant claims. Therefore, claims 1 and 8-9 are rejected as being unpatentable over U.S. Patent No. 11613577B2.
Conclusion
No claims are allowed.
Advisory Information
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/JOSEPH D. CESARE/ Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675