DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election of Group III and species (A) non-small cell lung cancer as cancer and (B) immunostimulatory agent as additional agent in the reply filed on January 26, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). After further consideration, the species elections are withdrawn.
Claims 43-46, 53, and 56-67 are under consideration in this office action.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application claims benefit to U.S. Provisional Application No. 62/896,908 filed on September 6, 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 26, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because the “Sequence Listing XML,” as a separate part of the disclosure, is defective, damaged or unreadable.
SEQ ID NOs: 21, 27, 33, and 39 are defective. These SEQ ID NOs are blank in the Sequence listing XML because only consist of three amino acids. Three amino acid sequences must be represented in text form and cannot have a SEQ ID NO.
Required response - Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above submitted in accordance with either item 1. or 2.; together with
o A statement that identifies the location of all additions, deletions or replacements of sequence information relative to the replaced “Sequence Listing XML” as required by 37 CFR 1.835(b)(3);
o A statement that indicates support for the replacement “Sequence Listing XML” in the application, as filed, as required by 37 CFR 1.835(b)(4); and
o A statement that the replacement “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(b)(5).
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125, inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
Claim Interpretation
Claim 56 includes SEQ ID NOs: 21, 27, 33, and 39. These sequences are not included in the “Sequence listing XML” because they consist of only three amino acids. In the interest of compact prosecution, SEQ ID NO: 21 is interpreted to be the amino acid sequence KAS and SEQ ID NOs: 27, 33, and 39 are interpreted to be the amino acid sequence AAS, as set forth in Table 4 of the specification filed March 17, 2023.
Claim Objections
Claims 56 and 58 are objected to because of the following informalities:
Claims 56 use acronyms without first defining what they represent in the independent claims (i.e. H-CDR1-3 and L-CDR1-3). While the claims can reference acronyms, the material presented by the acronym must be clearly set forth at the first use of the acronym.
In claim 58, “Eu numbering” should be “EU numbering”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 56, 58, and 62-63 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 56 includes CDRs comprised of the amino acid sequences SEQ ID NOs: 21, 27, 33, and 39. These sequences consist of only three amino acids; as this application was filed after July 1, 2022, the “Sequence listing XML” must not include sequences having fewer than 4 specifically defined amino acids (see MPEP1.831). As such, these sequences were not included in the “Sequence listing XML” and are blank; thus, a person of skill in the art would not be able to determine the metes and bounds of the claim.
Claim 56 recites the limitation “the H-CDR1-3 and L-CDR1-3”. There is insufficient antecedent basis for this limitation in the claim. Claims 57-58
Claims 58 uses parentheses to enclose “Eu numbering”. The use of parentheses that encompass a limitation in the claim is found indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention or are just set forth as possible examples.
Claims 57-67 are included in this rejection for failing to cure the indefiniteness of claim 56. Appropriate correction is required.
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 43-46, and 56-67 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,634,500. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to overlapping embodiments: a method for decreasing CD73 activity, increasing CD4+ T cell proliferation, stimulating the immune system, and treating cancer comprising administering the same anti-CD73 antibodies.
Claim 1 of ‘500 teaches anti-CD73 antibodies comprised of HCDR1-3 and LCDR1-3 of SEQ ID NOs: 17-22, 23-28, 29,34, and 35-40, which are identical to the antibodies of instant claim 56 (same SEQ ID NOs). Claim 2 of ‘500 teaches anti-CD73 antibodies comprised of heavy and light chain variable regions comprised of SEQ ID NOs: 9 and 13, 10 and 14, 11 and 15 and 12 and 16, which reads on the antibodies of instant claims 43 and 46 (same SEQ ID NOs).
Claim 14-20 of ‘500 are directed to a method of decreasing CD73 activity, increasing CD4+ T cell proliferation, stimulating the immune system, and treating cancer, which reads on instant claim 42. The cancer is melanoma, head and neck cancer, breast cancer, bladder cancer, non-small cell lung cancer, pancreatic cancer, ovarian cancer, renal cell carcinoma, prostate cancer, colorectal cancer, cholangiocarcinoma, thyroid cancer, or testicular cancer, which reads on the instant claims 44, 63, 65, and 67. The cancer of ‘500 originates from skin, lung, intestine, colon, ovary, brain, prostate, kidney, soft tissues, the hematopoietic system, head and neck, liver, bone, bladder, breast, stomach, uterus, cervix, or pancreas, which reads on instant claims 62, 64, and 66.
The antibody of ‘500 claim 5 is an IgG1 where one or both of the amino acid residues at positions 234 and 235 are mutated from Leu to Ala, which reads on instant claim 58.
The method of ‘500 comprises further administering an immunostimulatory agent, a vaccine, a chemotherapeutic agent, an anti-neoplastic agent, an anti-angiogenic agent, a tyrosine kinase inhibitor, a CD73 pathway inhibitor, or radiation therapy, which reads on instant claim 45.
Claims 43-46, 53, and 56-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,634,500 in view of US 20190225703, published July 25, 2019 (“Caux”; instant PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to overlapping embodiments: a method for decreasing CD73 activity, increasing CD4+ T cell proliferation, stimulating the immune system, and treating cancer comprising administering the same anti-CD73 antibodies.
The teachings of the claims of patent ‘500 are discussed above. ‘500 claims do not teach the method wherein the immunostimulatory agent is an anti-PD-1 antibody.
Caux teaches a method for increasing T cell proliferation and treating cancer comprising administering anti-CD73 antibodies [0010]. The anti-CD73 antibody may be administered in combination with an anti-PD-1 antibody [0050].
Given that the claims of ‘500 teach a method of decreasing CD73 activity, increasing CD4+ T cell proliferation, stimulating the immune system, and treating cancer and further given that Caux teaches methods comprised of co-administering anti-CD73 antibody and anti-PD-1 antibody, it would have been obvious to one of ordinary skill in the art to add an anti-PD-1 antibody therapeutic to the method of the claims of ‘500 and have a reasonable expectation of success, because one is applying a known technique to a known method ready for improvement to yield predictable results (see MPEP 2143 I.E.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675