CTNF 18/484,631 CTNF 98757 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Status of the Claims Claims 1 – 14, 16 – 22, 26 – 37, 39 – 41, 44, 47, 51 – 54, 56, 58, 60 – 66 and 68 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims. Information Disclosure Statement The information disclosure statements filed on 03/09/2026 does not fully comply with the requirements of 37 CFR 1.98(b) because Non-Patent Literature Cite No. 62 does not include valid publication date. Applicant must indicate the date of publication of each reference. Claim Objections 07-29-01 AIA Claim s 13 and 27 are objected to because of the following informalities: The abbreviation “AUC” is used in claims 13 and 27 without defining the acronym. At the first use in the claims, this abbreviation should be written-out in expanded form to improve clarity and readability of the claims . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 51 – 54, 56, 58, 60 – 66 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. MPEP 2173.05 (p)(II) states that a single claim which claims both an apparatus (or product) and the method steps of using the apparatus (or product) is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112 , second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). Claims 51 – 54, 56, 58, 60 – 66 recite “the method or pharmaceutical composition” in the preamble. However, combining a method and a composition in the same claim creates confusion about the core invention, as method claims focus on action, while composition claims focus on structure. The two different categories should be separated into distinct claims: claims for the method of use and separate claims for the pharmaceutical composition. Furthermore, "pharmaceutical composition" in the preamble of present claims 51 – 54, 56, 58, 60 – 66 lacks antecedent basis. All of these claims ultimately depend from claim 1 and claim 1 does not recite a pharmaceutical composition. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claim s 7 – 10 are rejected under 35 U.S.C. 102( a)(1)/(a)(2 ) as being anticipated by KRISHNAMACHARI (US 2022/0089738 A1, filed 09/23/2021, published 03/24/2022; an IDS reference submitted 03/09/2026) . Independent claim 7 is directed to a method of treating cancer in a human patient in need thereof comprising subcutaneously administering to the patient a dose of from about 300 mg to about 500 mg of an anti-PD-1 antibody, or antigen binding fragment thereof, and a human hyaluronidase, every three weeks, wherein the anti-PD-1 antibody, or antigen binding fragment, comprises: a light chain (LC) variable region comprising complementarity determining regions (CDRs) LC-CDR1, LC-CDR2 and LC-CDR3 comprising a sequence of amino acids as set forth in SEQ ID NOs: 1, 2 and 3, respectively, and a heavy chain (HC) variable region comprising CDRs HC-CDR1, HC-CDR2 and HC-CDR3 comprising a sequence of amino acids as set forth in SEQ ID NOs: 6, 7 and 8, respectively. According to the present specification, the anti-PD-1 antibody is pembrolizumab (all throughout the specification, for example, at p. 3, lines 28 – 30). KRISHNAMACHARI is directed to stable formulations of antibodies against human programmed death receptor PD-1, or antigen binding fragments thereof and a PH20 (which is human hyaluronidase, according to paragraph 0004 of KRISHNAMACHARI ) variant or fragment thereof and further provides methods for treating various cancers with formulations. See abstract. KRISHNAMACHARI teaches that the formulations of the disclosed methods are administered to a subject by subcutaneous administration. See abstract. KRISHNAMACHARI teaches an anti-human PD-1 antibody or antigen binding fragment thereof that comprises a light chain variable region which comprises the amino acid sequence set forth in SEQ ID NO:4, and a heavy chain variable region comprising the amino acid sequence set forth in SEQ ID NO:9 (see KRISHNAMACHARI ’s claim 45). KRISHNAMACHARI ’s SEQ ID NO: 4 teaches the CDRs of present SEQ ID NOs: 1 – 3 of present claims 1 – 2, 7, 44 and 47 with 100% identity; and KRISHNAMACHARI ’s SEQ ID NO: 9 teaches the CDRs of present SEQ ID NOs: 6 – 8 of present claims 1 – 2, 7, 44 and 47 with 100% identity. See Appendix. KRISHNAMACHARI teaches a dosing interval will be about 3 weeks. See paragraphs 0379 and 0375. KRISHNAMACHARI teaches that the effective amount of the formulation comprises a dose of anti-human PD-1 antibody of 200 to 400 mg. See paragraph 0395. Thus, KRISHNAMACHARI anticipates present claims 7 - 10 . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim s 1 – 6, 11 – 14, 16 – 22, 28 – 37, 39 – 41, 44, 47, 51 – 54, 56, 58, 60 – 66 and 68 are rejected under 35 U.S.C. 103 as being unpatentable over KRISHNAMACHARI . Independent claim 1 is directed to a method of treating cancer in a human patient in need thereof comprising subcutaneously administering to the patient a dose of from about 600 mg to about 1000 mg of an anti-PD-1 antibody, or antigen binding fragment thereof, and a human hyaluronidase, every six weeks, wherein the anti-PD-1 antibody, or antigen binding fragment thereof, comprises: a light chain (LC) variable region comprising complementarity determining regions (CDRs) LC-CDR1, LC-CDR2 and LC-CDR3 comprising a sequence of amino acids as set forth in SEQ ID NOs: 1, 2 and 3, respectively, and a heavy chain (HC) variable region comprising CDRs HC-CDR1, HC-CDR2 and HC-CDR3 comprising a sequence of amino acids as set forth in SEQ ID NOs: 6, 7 and 8, respectively. The teachings of KRISHNAMACHARI are discussed above and incorporated here. KRISHNAMACHARI teaches that the dosing interval will be about 6 weeks. See paragraph 0379. The only difference between present claims 1 – 2, and 44 and KRISHNAMACHARI ’s method is that present claims 1 – 2, and 44 recite a dose of from about 600 mg to about 1000 mg of an anti-PD-1 antibody, or antigen binding fragment thereof, which is not expressly taught by KRISHNAMACHARI . However, KRISHNAMACHARI teaches that the effective amount of the formulation comprises a dose of anti-human PD-1 antibody of 200 to 400 mg and teaches that a pharmaceutical antibody formulation can be administered by continuous infusion, or by doses at intervals of, e.g., one day, 1-7 times per week, one week, two weeks, three weeks, monthly, bimonthly, etc. and a total weekly dose is generally at least 0.05 μg/kg, 0.2 μg/kg, 0.5 μg/kg, 1 μg/kg, 10 μg/kg, 100 μg/kg, 0.2 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 10 mg/kg, 25 mg/kg, 50 mg/kg body weight or more (see paragraph 0375). For example, with KRISHNAMACHARI ’s teaching of the administration of 10 mg/kg, a human of 62 kg would be administered a dose of 620 mg of an anti-PD-1 antibody, which is within the claimed range of present claims 1 – 2 and 44. Furthermore, KRISHNAMACHARI teaches that “pharmaceutically effective amount” or “effective amount” means an amount whereby sufficient therapeutic composition or formulation is introduced to a patient to treat a diseased or condition and that one skilled in the art recognizes that this level may vary according the patient's characteristics such as age, weight, etc. See paragraph 0087. Thus, a person having ordinary skill in the art can arrive to the claimed anti-PD-1 dosages of present claims 1 – 6 by routine experimentation in view of KRISHNAMACHARI ’s teachings. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)”. See MPEP 2144.05 (I) and (II). Regarding claim 2, KRISHNAMACHARI also teaches a pembrolizumab-only (anti-PD-1 antibody-only) formulation (no PH20 variant fragment 2). See paragraph 0418 and TABLE 5, p. 26. Regarding claims 11 – 13, although KRISHNAMACHARI does not expressly teach the C trough , SC:IV ratio, and AUC (0-6weeks) of the subcutaneous administration of the anti-PD-1 antibody, KRISHNAMACHARI teaches the subcutaneous administration of the exact anti-PD-1 antibody (pembrolizumab) of present claim 1 and renders the anti-PD-1 antibody dosage of present claim 1 obvious as discussed above. Thus, the active steps of KRISHNAMACHARI ’s method would be expected to result in the C trough , SC:IV ratio, and AUC (0-6weeks) properties of present claims 11 – 13. Regarding claims 14 and 36, KRISHNAMACHARI teaches the treatment of cancer, such as carcinoma, lymphoma, leukemia, blastoma, and sarcoma, squamous cell carcinoma, myeloma, small-cell lung cancer, non-small cell lung cancer, glioma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, gastrointestinal (tract) cancer, renal cancer, ovarian cancer, liver cancer, lymphoblastic leukemia, lymphocytic leukemia, colorectal cancer, endometrial cancer, kidney cancer, prostate cancer, thyroid cancer, melanoma, chondrosarcoma, neuroblastoma, pancreatic cancer, glioblastoma multiforme, cervical cancer, brain cancer, stomach cancer, bladder cancer, hepatoma, breast cancer, colon carcinoma, and head and neck cancer. See paragraph 0090. Regarding claim 16, KRISHNAMACHARI teaches that cancer is a solid tumor with a high mutational burden. See paragraph 0336. Regarding claim 17, KRISHNAMACHARI teaches a method of treating unresectable or metastatic melanoma in a human patient. See paragraph 0342. Regarding claim 18, KRISHNAMACHARI teaches that the cancer is metastatic non-small cell lung cancer (NSCLC). See paragraph 0343. Regarding claim 19, KRISHNAMACHARI teaches that the patient has a tumor with PD-L1 expression TPS≥1% and was previously treated with platinum-containing chemotherapy (see paragraph 0391) and the patient has a tumor with high PD-L1 expression [(Tumor Proportion Score (TPS)≥50%)] and was not previously treated with platinum-containing chemotherapy (see paragraph 0390). Regarding claim 20, KRISHNAMACHARI teaches that the patient's tumor has no EGFR or ALK genomic aberrations. See paragraph 0345. Regarding claim 21, KRISHNAMACHARI teaches administering pemetrexed and carboplatin to the patient (paragraph 0347) and that carboplatin is a platinum analog (see paragraph 0091). Regarding claim 22, KRISHNAMACHARI teaches that the patient has nonsquamous non-small cell lung cancer and that pemetrexed is administered to the patient in an amount of 500 mg/m 2 via intravenous infusion every 21 days. See paragraphs 0348 – 0349. Regarding claim 28, KRISHNAMACHARI teaches a method of treating metastatic non-small cell lung cancer (NSCLC) in a human patient. See paragraph 0343. Thus, it would have been obvious that the cancer is resected Stage IB, II, or IIIA non-small cell lung cancer. Regarding claim 29, KRISHNAMACHARI teaches a method of treating recurrent or metastatic head and neck squamous cell cancer (HNSCC) in a human patient. See paragraph 0351. Regarding claim 30, KRISHNAMACHARI teaches that the patient's tumor expresses PD-L1 [Combined Positive Score (CPS)≥1. See paragraph 0351. Regarding claim 31, KRISHNAMACHARI teaches a method of treating refractory classical Hodgkin lymphoma (cHL) in a human patient. See paragraph 0352. Regarding claim 32, KRISHNAMACHARI teaches a method of treating locally advanced or metastatic urothelial carcinoma in a human patient. See paragraph 0353. Regarding claim 33, KRISHNAMACHARI teaches treating breast cancer that is ER+/HER2− breast cancer. See paragraph 0331. Regarding claim 34, KRISHNAMACHARI teaches that the patient's tumor expresses PD-L1 [Combined Positive Score (CPS)≥1 (see paragraph 0351), and because KRISHNAMACHARI teaches the claimed method of present claim 1 (from which claim 34 indirectly depends) as discussed above, the active steps of KRISHNAMACHARI ’s method would be expected to treat a patient whose tumor expresses PD-L1 [Combined Positive Score (CPS)≥10 as recited in present claim 34. Regarding claim 35, KRISHNAMACHARI teaches a method of treating advanced renal cell carcinoma in a human patient. See paragraph 0360. Regarding claim 36, KRISHNAMACHARI teaches a squamous cell carcinoma, myeloma, small-cell lung cancer, non-small cell lung cancer, glioma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, gastrointestinal (tract) cancer, renal cancer, ovarian cancer, liver cancer, lymphoblastic leukemia, lymphocytic leukemia, colorectal cancer, endometrial cancer, kidney cancer, prostate cancer, thyroid cancer, melanoma, chondrosarcoma, neuroblastoma, pancreatic cancer, glioblastoma multiforme, cervical cancer, brain cancer, stomach cancer, bladder cancer, hepatoma, breast cancer, colon carcinoma, and head and neck cancer. See paragraph 0090. Regarding claim 37 and 39 - 41, KRISHNAMACHARI teaches that co-formulated samples were prepared as 165 mg/mL Pembrolizumab, 2000 Units/mL Recombinant Human Hyaluronidase PH20 variant. See paragraph 0428. Thus, about 600mg of Pembrolizumab would be approximately 3.6 mL, which would be approximately 7273 Units of hyaluronidase and at a ratio of 12.12 Units: 1 mg which is within hundredths of the ratio of present claim 41. Regarding claim 47, KRISHNAMACHARI teaches that 2000 U/ml of PH20 variant is about 0.012 mg/ml (see paragraph 0136) and teaches a formulation comprising: a) about 20 mg/mL to about 200 mg/mL of an anti-human PD-1 antibody, or antigen binding fragment thereof; b) about 0.0009-0.050 mg/ml of a PH20 variant or fragment thereof (see KRISHNAMACHARI ’s claim 1). The lowest amounts in KRISHNAMACHARI ’s range in KRISHNAMACHARI ’s claim 1 is 20mg/mL of an anti-human PD-1 antibody and 0.0009 mg/mL a PH20 variant, which would be a ratio of 0.000045 mg PH20 variant: 1 mg anti-human PD-1 antibody. Because KRISHNAMACHARI teaches that 2000 U/ml of PH20 variant is about 0.012 mg/ml, 0.000045 mg/ml of PH20 variant would be 7.5 U/ml. Thus, KRISHNAMACHARI teaches a ratio of 7.5 Units of human hyaluronidase: 1 mg anti-PD-1 antibody, which falls within the claimed range of present claim 47. Furthermore, as discussed above, KRISHNAMACHARI teaches that the effective amount of the formulation comprises a dose of anti-human PD-1 antibody of 200 to 400 mg (see paragraph 0395), which overlaps the claimed range of about 300 mg to about 500 mg of an anti-PD-1 antibody. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)”. See MPEP 2144.05 (I) and (II). Regarding claim 51, KRISHNAMACHARI teaches a variant of PH20 that has amino acid residue substitutions including M345T, S347T, M348K, K349E, L352Q, L353A, L354I, D355K, N356E, E359D, and I361T in SEQ ID NO: 21. See paragraph 0134. KRISHNAMACHARI ’s SEQ ID NO: 21 is identical to present SEQ ID NO: 16 of present claim 51. See Appendix. Regarding claim 52, KRISHNAMACHARI teaches a “PH20 variant fragment” or “PH20 variant fragment thereof” “or “fragment of a PH20 variant” is a PH20 variant that has either an N-terminus deletion of amino acid residues 1-36, 1-37, 1-38, 1-39, 1-40, 1-41, or 1-42 of SEQ ID NO: 21; and/or a C-terminus deletion of amino acid residues 455-509, 456-509, 457-509, 458-509, 459-509, 460-509, 461-509, 462-509, 463-509, 464-509, 465-509, 466-509, 467-509, 468-509, 469-509, 470-509, 471-509, 472-509, 473-509, 474-509, 475-509, 476-509, 477-509, 478-509, 479-509, 480-509, 481-509, 482-509, 483-509, 484-509, 485-509, 486-509, 487-509, 488-509, 489-509, 490-509, 491-509, 492-509, 493-509, 494-509, 495-509, 496-509, 497-509, 498-509, 499-509, 500-509, 501-509, 502-509, 503-509, 504-509, 505-509, 506-509, 507-509, 508-509, or 509, wherein the numbering is by reference to SEQ ID NO: 21. Regarding claim 53, KRISHNAMACHARI teaches a formulation of that comprises a PH20 variant fragment consisting of the amino acid sequence set forth in SEQ ID NO: 23 (see KRISHNAMACHARI ’s claim 55). KRISHNAMACHARI ’s SEQ ID NO: 23 is identical to present SEQ ID NO: 18 of present claim 53. See Appendix. Regarding claim 54, KRISHNAMACHARI teaches the PH20 variant fragment consists of the amino acid sequence set forth in SEQ ID NO: 22 (see paragraph 0234). KRISHNAMACHARI ’s SEQ ID NO: 22 is identical to present SEQ ID NO: 17 of present claim 54. See Appendix. Regarding claim 56, KRISHNAMACHARI teaches that the anti-human PD-1 antibody or antigen binding fragment thereof comprises a light chain variable region which comprises the amino acid sequence set forth in SEQ ID NO:4, and a heavy chain variable region comprising the amino acid sequence set forth in SEQ ID NO:9 (see KRISHNAMACHARI ’s claim 45). KRISHNAMACHARI ’s SEQ ID NO: 9 is identical to present SEQ ID NO: 9 of present claim 56, and KRISHNAMACHARI ’s SEQ ID NO: 4 is identical to present SEQ ID NO: 4 of present claim 56. See Appendix Regarding claim 58, KRISHNAMACHARI teaches that the anti-human PD-1 antibody comprises a light chain comprising the amino acid sequence set forth in SEQ ID NO:5 and a heavy chain comprising the amino acid sequence set forth in SEQ ID NO:10. KRISHNAMACHARI ’s SEQ ID NO: 10 is identical to present SEQ ID NO: 10 of present claim 58, and KRISHNAMACHARI ’s SEQ ID NO: 5 is identical to present SEQ ID NO: 5 of present claim 58. See Appendix. Regarding claim 60, KRISHNAMACHARI teaches that the anti-PD-1 antibody comprises a heavy chain and a light chain, wherein the light and heavy chains comprise the amino acid sequences SEQ ID NO:5 and SEQ ID NO:10. See paragraph 0014. KRISHNAMACHARI ’s SEQ ID NO: 10 teaches present SEQ ID NO: 11 of present claim 60 with 100% identity, and KRISHNAMACHARI ’s SEQ ID NO: 5 is identical to present SEQ ID NO: 5 of present claim 60. See Appendix. Regarding claims 61 – 62, KRISHNAMACHARI teaches that the anti-PD-1 antibody is pembrolizumab or an antigen binding fragment or a pembrolizumab variant. See paragraph 0036 and claims 47 – 48. Regarding claim 63, KRISHNAMACHARI teaches a formulation that comprises about 130 mg/mL of an anti-human PD-1 antibody, or antigen binding fragment thereof. See KRISHNAMACHARI ’s claims 30 – 31. Regarding claim 64, KRISHNAMACHARI teaches a formulation wherein the concentration of the anti-human PD-1 antibody or antigen binding fragment thereof is about 165 mg/mL. See KRISHNAMACHARI ’s claim 18. Regarding claims 65 – 66, KRISHNAMACHARI teaches that co-formulated samples were prepared as 165 mg/mL Pembrolizumab, 2000 Units/mL Recombinant Human Hyaluronidase PH20 variant. See paragraph 0428. Regarding claim 68, KRISHNAMACHARI teaches the patient's tumor has no EGFR or ALK genomic aberrations. See paragraph 0345 . 07-22-aia AIA Claim s 26 – 27 are rejected under 35 U.S.C. 103 as being unpatentable over KRISHNAMACHARI as applied to claim s 1 – 6, 11 – 14, 16 – 22, 28 – 37, 39 – 41, 44, 47, 51 – 54, 56, 58, 60 – 66 and 68 above, and further in view of PERLMUTTER (WO 2021/225851 A1, filed 04/29/2021, published 11/11/2021; see PTO-892: Notice of References Cited) . The teachings of KRISHNAMACHARI are discussed above and incorporated here. Although KRISHNAMACHARI teaches the method of present claim 1, from which claims 26 – 27 depend, either directly or indirectly, KRISHNAMACHARI does not expressly teach a treatment with a therapeutically effective amount of carboplatin and paclitaxel or nab-paclitaxel of present claim 26, and KRISHNAMACHARI does expressly teach that carboplatin is administered by intravenous infusion at an AUC of 5-6 mg/ml/min, the paclitaxel is administered by intravenous infusion 200 mg/m 2 every 21 days, and the nab-paclitaxel is administered by intravenous infusion 100 mg/m 2 every 7 days. PERLMUTTER is directed to methods of treating cancer using a combination of (a) one or more programmed death 1 protein (PD-1) antagonists, (b) a radiotherapy, (c) one or more poly (ADP-ribose) polymerase (PARP) inhibitor, and optionally, (d) one or more chemotherapies. See abstract. Regarding claims 26 – 27, PERLMUTTER teaches method of treating cancer, comprising administering to a patient in need thereof an anti-PD-1 antibody or an anti-PD-L2 antibody and chemotherapy such as carboplatin AUC 6 mg/mL/min IV with paclitaxel 200 mg/m 2 IV. See PERLMUTTER ’s claims 1, 4 and 21. It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of KRISHNAMACHARI and PERLMUTTER . The artisan would have been motivated to use the methods of claims 26 – 27 because KRISHNAMACHARI teaches that the methods utilize stable anti-PD-1 antibody formulations that exhibit stability over months to years (see paragraph 0006) and PERLMUTTER teaches which agent combined with the PD-1 antagonist may be effective or in which patients the combination may enhance the efficacy of treatment (see p.2, lines 11 - 16 ). The artisan would have a reasonable expectation of success with the combined teachings of the cited references because they teach that the steps in the methods result in an effective treatment of cancer. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Estella Gustilo whose telephone number is (703)756-1706. The examiner can normally be reached Monday - Friday 9:30 AM - 5:30 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, Gregory Emch can be reached at 571-272-8149. 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. /ESTELLA M. GUSTILO/Examiner, Art Unit 1646 /GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678 APPENDIX Alignment with CDRs of SEQ ID NOs: 1 – 3 BKU69394 ID BKU69394 standard; protein; 111 AA. XX AC BKU69394; XX DT 19-MAY-2022 (first entry) XX DE Anti-human PD-1 antibody IgG4 light chain variable region, SEQ: 4. XX KW MK-3475; PD-1 protein; Pembrolizumab; SCH 900475; antibody therapy; KW antimicrobial-gen.; cancer; cytostatic; humanized antibody; KW infectious disease; lambrolizumab; light chain variable region; KW monoclonal antibody; programmed death receptor 1; KW prophylactic to disease; therapeutic. XX OS Homo sapiens. OS Synthetic. XX CC PN US2022089738-A1. XX CC PD 24-MAR-2022. XX CC PF 23-SEP-2021; 2021US-00482650. XX PR 24-SEP-2020; 2020US-0082888P. XX CC PA (MERI ) MERCK SHARP & DOHME CORP. XX CC PI Zhao X, Su Y, Forrest WP, Sangani SS, Mittal S, Krishnamachari Y; XX DR WPI; 2022-42866T/038. XX CC PT Formulation for treating chronic infection and cancer, comprises anti- CC PT human PD-1 antibody, or antigen binding fragment, PH20 variant or CC PT fragment, buffer, non-reducing dissacharide selected from sucrose and CC PT trehalose, non-ionic surfactant. XX CC PS Claim 45; SEQ ID NO 4; 65pp; English. XX CC The present invention relates to a stable formulation of antibodies CC against human programmed death receptor (PD-1), or antigen-binding CC fragments, and a PH20 variant or fragment. Formulation comprises about 20 CC -200 mg/mL of an anti-human PD-1 antibody, or antigen-binding fragment, CC about 0 .0009-0 .050 mg/ml of a PH20 variant or fragment, about 5-20 mM CC buffer, about 3-10 wt. percent non-reducing disaccharide selected from CC the group consisting of sucrose and trehalose, about 0 .005-0 .10 wt. CC percent non-ionic surfactant, and optionally about 1 mM to about 30 mM CC antioxidant. The invention further discloses: (1) a method of treating CC chronic infection in a human patient in need, which involves CC administering an effective amount of the formulation to the patient; (2) CC a method of treating cancer in a human patient, which involves CC administering an effective amount of the formulation to the patient. The CC formulation for treating chronic infection in a human patient in need, CC and treating cancer in a human patient. XX SQ Sequence 111 AA; ALIGNMENT: Query Match 84.3%; Score 132.3; Length 111; Best Local Similarity 39.7%; Matches 31; Conservative 0; Mismatches 0; Indels 47; Gaps 2; Qy 1 RASKGVSTSGYSYLH---------------LASYLES----------------------- 22 ||||||||||||||| ||||||| Db 24 RASKGVSTSGYSYLHWYQQKPGQAPRLLIYLASYLESGVPARFSGSGSGTDFTLTISSLE 83 Qy 23 ---------QHSRDLPLT 31 ||||||||| Db 84 PEDFAVYYCQHSRDLPLT 101 Alignment with CDRs of SEQ ID NOs: 6 – 8 BKU69399 ID BKU69399 standard; protein; 120 AA. XX AC BKU69399; XX DT 19-MAY-2022 (first entry) XX DE Anti-human PD-1 antibody IgG4 heavy chain variable region, SEQ: 9. XX KW MK-3475; PD-1 protein; Pembrolizumab; SCH 900475; antibody therapy; KW antimicrobial-gen.; cancer; cytostatic; heavy chain variable region; KW humanized antibody; infectious disease; lambrolizumab; KW monoclonal antibody; programmed death receptor 1; KW prophylactic to disease; therapeutic. XX OS Homo sapiens. OS Synthetic. XX CC PN US2022089738-A1. XX CC PD 24-MAR-2022. XX CC PF 23-SEP-2021; 2021US-00482650. XX PR 24-SEP-2020; 2020US-0082888P. XX CC PA (MERI ) MERCK SHARP & DOHME CORP. XX CC PI Zhao X, Su Y, Forrest WP, Sangani SS, Mittal S, Krishnamachari Y; XX DR WPI; 2022-42866T/038. XX CC PT Formulation for treating chronic infection and cancer, comprises anti- CC PT human PD-1 antibody, or antigen binding fragment, PH20 variant or CC PT fragment, buffer, non-reducing dissacharide selected from sucrose and CC PT trehalose, non-ionic surfactant. XX CC PS Claim 45; SEQ ID NO 9; 65pp; English. XX CC The present invention relates to a stable formulation of antibodies CC against human programmed death receptor (PD-1), or antigen-binding CC fragments, and a PH20 variant or fragment. Formulation comprises about 20 CC -200 mg/mL of an anti-human PD-1 antibody, or antigen-binding fragment, CC about 0 .0009-0 .050 mg/ml of a PH20 variant or fragment, about 5-20 mM CC buffer, about 3-10 wt. percent non-reducing disaccharide selected from CC the group consisting of sucrose and trehalose, about 0 .005-0 .10 wt. CC percent non-ionic surfactant, and optionally about 1 mM to about 30 mM CC antioxidant. The invention further discloses: (1) a method of treating CC chronic infection in a human patient in need, which involves CC administering an effective amount of the formulation to the patient; (2) CC a method of treating cancer in a human patient, which involves CC administering an effective amount of the formulation to the patient. The CC formulation for treating chronic infection in a human patient in need, CC and treating cancer in a human patient. XX SQ Sequence 120 AA; ALIGNMENT: Query Match 87.2%; Score 167.4; Length 120; Best Local Similarity 41.8%; Matches 33; Conservative 0; Mismatches 0; Indels 46; Gaps 2; Qy 1 NYYMY--------------GINPSNGGTNFNEKFKN------------------------ 22 ||||| ||||||||||||||||| Db 31 NYYMYWVRQAPGQGLEWMGGINPSNGGTNFNEKFKNRVTLTTDSSTTTAYMELKSLQFDD 90 Qy 23 --------RDYRFDMGFDY 33 ||||||||||| Db 91 TAVYYCARRDYRFDMGFDY 109 Alignment with SEQ ID NO: 16 GenCore version 6.5.2 Copyright (c) 1993 - 2026 Biocceleration Ltd. OM protein - protein search, using sw model Run on: April 8, 2026, 19:14:28 ; Search time 1 Seconds (without alignments) 0.259 Million cell updates/sec Title: US-18-484-631-16 Perfect score: 2704 Sequence: 1 MGVLKFKHIFFRSFVKSSGV..........SATMFIVSILFLIISSVASL 509 Scoring table: BLOSUM62 Gapop 10.0 , Gapext 0.5 Searched: 1 seqs, 509 residues Total number of hits satisfying chosen parameters: 1 Minimum DB seq length: 0 Maximum DB seq length: inf Post-processing: Minimum Match 0% Maximum Match 100% Listing first 50 summaries Database : US-17-482-650-21.fasta:* SUMMARIES % Result Query No. Score Match Length DB ID Description ---------------------------------------------------------------------------- 1 2704 100.0 509 1 US-17-482-650-21 STABLE FORMULATION ALIGNMENTS RESULT 1 US-17-482-650-21 ( KRISHNAMACHARI : US20220089738A1) Query Match 100.0%; Score 2704; DB 1; Length 509; Best Local Similarity 100.0%; Matches 509; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 MGVLKFKHIFFRSFVKSSGVSQIVFTFLLIPCCLTLNFRAPPVIPNVPFLWAWNAPSEFC 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 MGVLKFKHIFFRSFVKSSGVSQIVFTFLLIPCCLTLNFRAPPVIPNVPFLWAWNAPSEFC 60 Qy 61 LGKFDEPLDMSLFSFIGSPRINATGQGVTIFYVDRLGYYPYIDSITGVTVNGGIPQKISL 120 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 61 LGKFDEPLDMSLFSFIGSPRINATGQGVTIFYVDRLGYYPYIDSITGVTVNGGIPQKISL 120 Qy 121 QDHLDKAKKDITFYMPVDNLGMAVIDWEEWRPTWARNWKPKDVYKNRSIELVQQQNVQLS 180 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 121 QDHLDKAKKDITFYMPVDNLGMAVIDWEEWRPTWARNWKPKDVYKNRSIELVQQQNVQLS 180 Qy 181 LTEATEKAKQEFEKAGKDFLVETIKLGKLLRPNHLWGYYLFPDCYNHHYKKPGYNGSCFN 240 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 181 LTEATEKAKQEFEKAGKDFLVETIKLGKLLRPNHLWGYYLFPDCYNHHYKKPGYNGSCFN 240 Qy 241 VEIKRNDDLSWLWNESTALYPSIYLNTQQSPVAATLYVRNRVREAIRVSKIPDAKSPLPV 300 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 241 VEIKRNDDLSWLWNESTALYPSIYLNTQQSPVAATLYVRNRVREAIRVSKIPDAKSPLPV 300 Qy 301 FAYTRIVFTDQVLKFLSQDELVYTFGETVALGASGIVIWGTLSIMRSMKSCLLLDNYMET 360 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 301 FAYTRIVFTDQVLKFLSQDELVYTFGETVALGASGIVIWGTLSIMRSMKSCLLLDNYMET 360 Qy 361 ILNPYIINVTLAAKMCSQVLCQEQGVCIRKNWNSSDYLHLNPDNFAIQLEKGGKFTVRGK 420 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 361 ILNPYIINVTLAAKMCSQVLCQEQGVCIRKNWNSSDYLHLNPDNFAIQLEKGGKFTVRGK 420 Qy 421 PTLEDLEQFSEKFYCSCYSTLSCKEKADVKDTDAVDVCIADGVCIDAFLKPPMETEEPQI 480 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 421 PTLEDLEQFSEKFYCSCYSTLSCKEKADVKDTDAVDVCIADGVCIDAFLKPPMETEEPQI 480 Qy 481 FYNASPSTLSATMFIVSILFLIISSVASL 509 ||||||||||||||||||||||||||||| Db 481 FYNASPSTLSATMFIVSILFLIISSVASL 509 Alignment of SEQ ID NO: 18 BKU69413 ID BKU69413 standard; protein; 431 AA. XX AC BKU69413; XX DT 19-MAY-2022 (first entry) XX DE Human PH20 protein variant fragment, SEQ ID NO: 23. XX KW Hyaluronidase PH20; PH20 protein; antibody therapy; antimicrobial-gen.; KW cancer; cytostatic; infectious disease; mutein; prophylactic to disease; KW therapeutic. XX OS Homo sapiens. OS Synthetic. XX CC PN US2022089738-A1. XX CC PD 24-MAR-2022. XX CC PF 23-SEP-2021; 2021US-00482650. XX PR 24-SEP-2020; 2020US-0082888P. XX CC PA (MERI ) MERCK SHARP & DOHME CORP. XX CC PI Zhao X, Su Y, Forrest WP, Sangani SS, Mittal S, Krishnamachari Y; XX DR WPI; 2022-42866T/038. XX CC PT Formulation for treating chronic infection and cancer, comprises anti- CC PT human PD-1 antibody, or antigen binding fragment, PH20 variant or CC PT fragment, buffer, non-reducing dissacharide selected from sucrose and CC PT trehalose, non-ionic surfactant. XX CC PS Claim 55; SEQ ID NO 23; 65pp; English. XX CC The present invention relates to a stable formulation of antibodies CC against human programmed death receptor (PD-1), or antigen-binding CC fragments, and a PH20 variant or fragment. Formulation comprises about 20 CC -200 mg/mL of an anti-human PD-1 antibody, or antigen-binding fragment, CC about 0 .0009-0 .050 mg/ml of a PH20 variant or fragment, about 5-20 mM CC buffer, about 3-10 wt. percent non-reducing disaccharide selected from CC the group consisting of sucrose and trehalose, about 0 .005-0 .10 wt. CC percent non-ionic surfactant, and optionally about 1 mM to about 30 mM CC antioxidant. The invention further discloses: (1) a method of treating CC chronic infection in a human patient in need, which involves CC administering an effective amount of the formulation to the patient; (2) CC a method of treating cancer in a human patient, which involves CC administering an effective amount of the formulation to the patient. The CC formulation for treating chronic infection in a human patient in need, CC and treating cancer in a human patient. XX SQ Sequence 431 AA; ALIGNMENT: Query Match 100.0%; Score 2327; Length 431; Best Local Similarity 100.0%; Matches 431; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 FRAPPVIPNVPFLWAWNAPSEFCLGKFDEPLDMSLFSFIGSPRINATGQGVTIFYVDRLG 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 FRAPPVIPNVPFLWAWNAPSEFCLGKFDEPLDMSLFSFIGSPRINATGQGVTIFYVDRLG 60 Qy 61 YYPYIDSITGVTVNGGIPQKISLQDHLDKAKKDITFYMPVDNLGMAVIDWEEWRPTWARN 120 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 61 YYPYIDSITGVTVNGGIPQKISLQDHLDKAKKDITFYMPVDNLGMAVIDWEEWRPTWARN 120 Qy 121 WKPKDVYKNRSIELVQQQNVQLSLTEATEKAKQEFEKAGKDFLVETIKLGKLLRPNHLWG 180 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 121 WKPKDVYKNRSIELVQQQNVQLSLTEATEKAKQEFEKAGKDFLVETIKLGKLLRPNHLWG 180 Qy 181 YYLFPDCYNHHYKKPGYNGSCFNVEIKRNDDLSWLWNESTALYPSIYLNTQQSPVAATLY 240 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 181 YYLFPDCYNHHYKKPGYNGSCFNVEIKRNDDLSWLWNESTALYPSIYLNTQQSPVAATLY 240 Qy 241 VRNRVREAIRVSKIPDAKSPLPVFAYTRIVFTDQVLKFLSQDELVYTFGETVALGASGIV 300 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 241 VRNRVREAIRVSKIPDAKSPLPVFAYTRIVFTDQVLKFLSQDELVYTFGETVALGASGIV 300 Qy 301 IWGSWENTRTKESCQAIKEYMDTTLNPYIINVTLAAKMCSQVLCQEQGVCIRKNWNSSDY 360 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 301 IWGSWENTRTKESCQAIKEYMDTTLNPYIINVTLAAKMCSQVLCQEQGVCIRKNWNSSDY 360 Qy 361 LHLNPDNFAIQLEKGGKFTVRGKPTLEDLEQFSEKFYCSCYSTLSCKEKADVKDTDAVDV 420 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 361 LHLNPDNFAIQLEKGGKFTVRGKPTLEDLEQFSEKFYCSCYSTLSCKEKADVKDTDAVDV 420 Qy 421 CIADGVCIDAF 431 ||||||||||| Db 421 CIADGVCIDAF 431 Alignment with SEQ ID NO: 17 BKU69412 ID BKU69412 standard; protein; 455 AA. XX AC BKU69412; XX DT 19-MAY-2022 (first entry) XX DE Human PH20 protein variant fragment, SEQ ID NO: 22. XX KW Hyaluronidase PH20; PH20 protein; antibody therapy; antimicrobial-gen.; KW cancer; cytostatic; infectious disease; mutein; prophylactic to disease; KW therapeutic. XX OS Homo sapiens. OS Synthetic. XX CC PN US2022089738-A1. XX CC PD 24-MAR-2022. XX CC PF 23-SEP-2021; 2021US-00482650. XX PR 24-SEP-2020; 2020US-0082888P. XX CC PA (MERI ) MERCK SHARP & DOHME CORP. XX CC PI Zhao X, Su Y, Forrest WP, Sangani SS, Mittal S, Krishnamachari Y; XX DR WPI; 2022-42866T/038. XX CC PT Formulation for treating chronic infection and cancer, comprises anti- CC PT human PD-1 antibody, or antigen binding fragment, PH20 variant or CC PT fragment, buffer, non-reducing dissacharide selected from sucrose and CC PT trehalose, non-ionic surfactant. XX CC PS Disclosure; SEQ ID NO 22; 65pp; English. XX CC The present invention relates to a stable formulation of antibodies CC against human programmed death receptor (PD-1), or antigen-binding CC fragments, and a PH20 variant or fragment. Formulation comprises about 20 CC -200 mg/mL of an anti-human PD-1 antibody, or antigen-binding fragment, CC about 0 .0009-0 .050 mg/ml of a PH20 variant or fragment, about 5-20 mM CC buffer, about 3-10 wt. percent non-reducing disaccharide selected from CC the group consisting of sucrose and trehalose, about 0 .005-0 .10 wt. CC percent non-ionic surfactant, and optionally about 1 mM to about 30 mM CC antioxidant. The invention further discloses: (1) a method of treating CC chronic infection in a human patient in need, which involves CC administering an effective amount of the formulation to the patient; (2) CC a method of treating cancer in a human patient, which involves CC administering an effective amount of the formulation to the patient. The CC formulation for treating chronic infection in a human patient in need, CC and treating cancer in a human patient. XX SQ Sequence 455 AA; ALIGNMENT: Query Match 100.0%; Score 2443; Length 455; Best Local Similarity 100.0%; Matches 455; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 LNFRAPPVIPNVPFLWAWNAPSEFCLGKFDEPLDMSLFSFIGSPRINATGQGVTIFYVDR 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 LNFRAPPVIPNVPFLWAWNAPSEFCLGKFDEPLDMSLFSFIGSPRINATGQGVTIFYVDR 60 Qy 61 LGYYPYIDSITGVTVNGGIPQKISLQDHLDKAKKDITFYMPVDNLGMAVIDWEEWRPTWA 120 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 61 LGYYPYIDSITGVTVNGGIPQKISLQDHLDKAKKDITFYMPVDNLGMAVIDWEEWRPTWA 120 Qy 121 RNWKPKDVYKNRSIELVQQQNVQLSLTEATEKAKQEFEKAGKDFLVETIKLGKLLRPNHL 180 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 121 RNWKPKDVYKNRSIELVQQQNVQLSLTEATEKAKQEFEKAGKDFLVETIKLGKLLRPNHL 180 Qy 181 WGYYLFPDCYNHHYKKPGYNGSCFNVEIKRNDDLSWLWNESTALYPSIYLNTQQSPVAAT 240 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 181 WGYYLFPDCYNHHYKKPGYNGSCFNVEIKRNDDLSWLWNESTALYPSIYLNTQQSPVAAT 240 Qy 241 LYVRNRVREAIRVSKIPDAKSPLPVFAYTRIVFTDQVLKFLSQDELVYTFGETVALGASG 300 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 241 LYVRNRVREAIRVSKIPDAKSPLPVFAYTRIVFTDQVLKFLSQDELVYTFGETVALGASG 300 Qy 301 IVIWGTLSITRTKESCQAIKEYMDTTLNPYIINVTLAAKMCSQVLCQEQGVCIRKNWNSS 360 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 301 IVIWGTLSITRTKESCQAIKEYMDTTLNPYIINVTLAAKMCSQVLCQEQGVCIRKNWNSS 360 Qy 361 DYLHLNPDNFAIQLEKGGKFTVRGKPTLEDLEQFSEKFYCSCYSTLSCKEKADVKDTDAV 420 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 361 DYLHLNPDNFAIQLEKGGKFTVRGKPTLEDLEQFSEKFYCSCYSTLSCKEKADVKDTDAV 420 Qy 421 DVCIADGVCIDAFLKPPMETEEPQIFYNASPSTLS 455 ||||||||||||||||||||||||||||||||||| Db 421 DVCIADGVCIDAFLKPPMETEEPQIFYNASPSTLS 455 Alignment with SEQ ID NO: 9 BKU69399 ID BKU69399 standard; protein; 120 AA. XX AC BKU69399; XX DT 19-MAY-2022 (first entry) XX DE Anti-human PD-1 antibody IgG4 heavy chain variable region, SEQ: 9. XX KW MK-3475; PD-1 protein; Pembrolizumab; SCH 900475; antibody therapy; KW antimicrobial-gen.; cancer; cytostatic; heavy chain variable region; KW humanized antibody; infectious disease; lambrolizumab; KW monoclonal antibody; programmed death receptor 1; KW prophylactic to disease; therapeutic. XX OS Homo sapiens. OS Synthetic. XX CC PN US2022089738-A1. XX CC PD 24-MAR-2022. XX CC PF 23-SEP-2021; 2021US-00482650. XX PR 24-SEP-2020; 2020US-0082888P. XX CC PA (MERI ) MERCK SHARP & DOHME CORP. XX CC PI Zhao X, Su Y, Forrest WP, Sangani SS, Mittal S, Krishnamachari Y; XX DR WPI; 2022-42866T/038. XX CC PT Formulation for treating chronic infection and cancer, comprises anti- CC PT human PD-1 antibody, or antigen binding fragment, PH20 variant or CC PT fragment, buffer, non-reducing dissacharide selected from sucrose and CC PT trehalose, non-ionic surfactant. XX CC PS Claim 45; SEQ ID NO 9; 65pp; English. XX CC The present invention relates to a stable formulation of antibodies CC against human programmed death receptor (PD-1), or antigen-binding CC fragments, and a PH20 variant or fragment. Formulation comprises about 20 CC -200 mg/mL of an anti-human PD-1 antibody, or antigen-binding fragment, CC about 0 .0009-0 .050 mg/ml of a PH20 variant or fragment, about 5-20 mM CC buffer, about 3-10 wt. percent non-reducing disaccharide selected from CC the group consisting of sucrose and trehalose, about 0 .005-0 .10 wt. CC percent non-ionic surfactant, and optionally about 1 mM to about 30 mM CC antioxidant. The invention further discloses: (1) a method of treating CC chronic infection in a human patient in need, which involves CC administering an effective amount of the formulation to the patient; (2) CC a method of treating cancer in a human patient, which involves CC administering an effective amount of the formulation to the patient. The CC formulation for treating chronic infection in a human patient in need, CC and treating cancer in a human patient. XX SQ Sequence 120 AA; ALIGNMENT: Query Match 100.0%; Score 647; Length 120; Best Local Similarity 100.0%; Matches 120; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 QVQLVQSGVEVKKPGASVKVSCKASGYTFTNYYMYWVRQAPGQGLEWMGGINPSNGGTNF 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 QVQLVQSGVEVKKPGASVKVSCKASGYTFTNYYMYWVRQAPGQGLEWMGGINPSNGGTNF 60 Qy 61 NEKFKNRVTLTTDSSTTTAYMELKSLQFDDTAVYYCARRDYRFDMGFDYWGQGTTVTVSS 120 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 61 NEKFKNRVTLTTDSSTTTAYMELKSLQFDDTAVYYCARRDYRFDMGFDYWGQGTTVTVSS 120 Alignment with SEQ ID NO: 4 BKU69394 ID BKU69394 standard; protein; 111 AA. XX AC BKU69394; XX DT 19-MAY-2022 (first entry) XX DE Anti-human PD-1 antibody IgG4 light chain variable region, SEQ: 4. XX KW MK-3475; PD-1 protein; Pembrolizumab; SCH 900475; antibody therapy; KW antimicrobial-gen.; cancer; cytostatic; humanized antibody; KW infectious disease; lambrolizumab; light chain variable region; KW monoclonal antibody; programmed death receptor 1; KW prophylactic to disease; therapeutic. XX OS Homo sapiens. OS Synthetic. XX CC PN US2022089738-A1. XX CC PD 24-MAR-2022. XX CC PF 23-SEP-2021; 2021US-00482650. XX PR 24-SEP-2020; 2020US-0082888P. XX CC PA (MERI ) MERCK SHARP & DOHME CORP. XX CC PI Zhao X, Su Y, Forrest WP, Sangani SS, Mittal S, Krishnamachari Y; XX DR WPI; 2022-42866T/038. XX CC PT Formulation for treating chronic infection and cancer, comprises anti- CC PT human PD-1 antibody, or antigen binding fragment, PH20 variant or CC PT fragment, buffer, non-reducing dissacharide selected from sucrose and CC PT trehalose, non-ionic surfactant. XX CC PS Claim 45; SEQ ID NO 4; 65pp; English. XX CC The present invention relates to a stable formulation of antibodies CC against human programmed death receptor (PD-1), or antigen-binding CC fragments, and a PH20 variant or fragment. Formulation comprises about 20 CC -200 mg/mL of an anti-human PD-1 antibody, or antigen-binding fragment, CC about 0 .0009-0 .050 mg/ml of a PH20 variant or fragment, about 5-20 mM CC buffer, about 3-10 wt. percent non-reducing disaccharide selected from CC the group consisting of sucrose and trehalose, about 0 .005-0 .10 wt. CC percent non-ionic surfactant, and optionally about 1 mM to about 30 mM CC antioxidant. The invention further discloses: (1) a method of treating CC chronic infection in a human patient in need, which involves CC administering an effective amount of the formulation to the patient; (2) CC a method of treating cancer in a human patient, which involves CC administering an effective amount of the formulation to the patient. The CC formulation for treating chronic infection in a human patient in need, CC and treating cancer in a human patient. XX SQ Sequence 111 AA; ALIGNMENT: Query Match 100.0%; Score 576; Length 111; Best Local Similarity 100.0%; Matches 111; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 EIVLTQSPATLSLSPGERATLSCRASKGVSTSGYSYLHWYQQKPGQAPRLLIYLASYLES 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 EIVLTQSPATLSLSPGERATLSCRASKGVSTSGYSYLHWYQQKPGQAPRLLIYLASYLES 60 Qy 61 GVPARFSGSGSGTDFTLTISSLEPEDFAVYYCQHSRDLPLTFGGGTKVEIK 111 ||||||||||||||||||||||||||||||||||||||||||||||||||| Db 61 GVPARFSGSGSGTDFTLTISSLEPEDFAVYYCQHSRDLPLTFGGGTKVEIK 111 Alignment with SEQ ID NO: 10 BKU69400 ID BKU69400 standard; protein; 447 AA. XX AC BKU69400; XX DT 19-MAY-2022 (first entry) XX DE Anti-human PD-1 antibody IgG4 heavy chain, SEQ: 10. XX KW MK-3475; PD-1 protein; Pembrolizumab; SCH 900475; antibody therapy; KW antimicrobial-gen.; cancer; cytostatic; heavy chain; humanized antibody; KW infectious disease; lambrolizumab; monoclonal antibody; KW programmed death receptor 1; prophylactic to disease; therapeutic. XX OS Homo sapiens. OS Synthetic. XX CC PN US2022089738-A1. XX CC PD 24-MAR-2022. XX CC PF 23-SEP-2021; 2021US-00482650. XX PR 24-SEP-2020; 2020US-0082888P. XX CC PA (MERI ) MERCK SHARP & DOHME CORP. XX CC PI Zhao X, Su Y, Forrest WP, Sangani SS, Mittal S, Krishnamachari Y; XX DR WPI; 2022-42866T/038. XX CC PT Formulation for treating chronic infection and cancer, comprises anti- CC PT human PD-1 antibody, or antigen binding fragment, PH20 variant or CC PT fragment, buffer, non-reducing dissacharide selected from sucrose and CC PT trehalose, non-ionic surfactant. XX CC PS Claim 46; SEQ ID NO 10; 65pp; English. XX CC The present invention relates to a stable formulation of antibodies CC against human programmed death receptor (PD-1), or antigen-binding CC fragments, and a PH20 variant or fragment. Formulation comprises about 20 CC -200 mg/mL of an anti-human PD-1 antibody, or antigen-binding fragment, CC about 0 .0009-0 .050 mg/ml of a PH20 variant or fragment, about 5-20 mM CC buffer, about 3-10 wt. percent non-reducing disaccharide selected from CC the group consisting of sucrose and trehalose, about 0 .005-0 .10 wt. CC percent non-ionic surfactant, and optionally about 1 mM to about 30 mM CC antioxidant. The invention further discloses: (1) a method of treating CC chronic infection in a human patient in need, which involves CC administering an effective amount of the formulation to the patient; (2) CC a method of treating cancer in a human patient, which involves CC administering an effective amount of the formulation to the patient. The CC formulation for treating chronic infection in a human patient in need, CC and treating cancer in a human patient. XX SQ Sequence 447 AA; ALIGNMENT: Query Match 100.0%; Score 2393; Length 447; Best Local Similarity 100.0%; Matches 447; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 QVQLVQSGVEVKKPGASVKVSCKASGYTFTNYYMYWVRQAPGQGLEWMGGINPSNGGTNF 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 QVQLVQSGVEVKKPGASVKVSCKASGYTFTNYYMYWVRQAPGQGLEWMGGINPSNGGTNF 60 Qy 61 NEKFKNRVTLTTDSSTTTAYMELKSLQFDDTAVYYCARRDYRFDMGFDYWGQGTTVTVSS 120 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 61 NEKFKNRVTLTTDSSTTTAYMELKSLQFDDTAVYYCARRDYRFDMGFDYWGQGTTVTVSS 120 Qy 121 ASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 180 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 121 ASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS 180 Qy 181 GLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSV 240 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 181 GLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSV 240 Qy 241 FLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTY 300 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 241 FLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTY 300 Qy 301 RVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTK 360 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 301 RVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTK 360 Qy 361 NQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEG 420 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 361 NQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEG 420 Qy 421 NVFSCSVMHEALHNHYTQKSLSLSLGK 447 ||||||||||||||||||||||||||| Db 421 NVFSCSVMHEALHNHYTQKSLSLSLGK 447 Alignment with SEQ ID NO: 5 BKU69395 ID BKU69395 standard; protein; 218 AA. XX AC BKU69395; XX DT 19-MAY-2022 (first entry) XX DE Anti-human PD-1 antibody IgG4 light chain, SEQ: 5. XX KW MK-3475; PD-1 protein; Pembrolizumab; SCH 900475; antibody therapy; KW antimicrobial-gen.; cancer; cytostatic; humanized antibody; KW infectious disease; lambrolizumab; light chain; monoclonal antibody; KW programmed death receptor 1; prophylactic to disease; therapeutic. XX OS Homo sapiens. OS Synthetic. XX CC PN US2022089738-A1. XX CC PD 24-MAR-2022. XX CC PF 23-SEP-2021; 2021US-00482650. XX PR 24-SEP-2020; 2020US-0082888P. XX CC PA (MERI ) MERCK SHARP & DOHME CORP. XX CC PI Zhao X, Su Y, Forrest WP, Sangani SS, Mittal S, Krishnamachari Y; XX DR WPI; 2022-42866T/038. XX CC PT Formulation for treating chronic infection and cancer, comprises anti- CC PT human PD-1 antibody, or antigen binding fragment, PH20 variant or CC PT fragment, buffer, non-reducing dissacharide selected from sucrose and CC PT trehalose, non-ionic surfactant. XX CC PS Claim 46; SEQ ID NO 5; 65pp; English. XX CC The present invention relates to a stable formulation of antibodies CC against human programmed death receptor (PD-1), or antigen-binding CC fragments, and a PH20 variant or fragment. Formulation comprises about 20 CC -200 mg/mL of an anti-human PD-1 antibody, or antigen-binding fragment, CC about 0 .0009-0 .050 mg/ml of a PH20 variant or fragment, about 5-20 mM CC buffer, about 3-10 wt. percent non-reducing disaccharide selected from CC the group consisting of sucrose and trehalose, about 0 .005-0 .10 wt. CC percent non-ionic surfactant, and optionally about 1 mM to about 30 mM CC antioxidant. The invention further discloses: (1) a method of treating CC chronic infection in a human patient in need, which involves CC administering an effective amount of the formulation to the patient; (2) CC a method of treating cancer in a human patient, which involves CC administering an effective amount of the formulation to the patient. The CC formulation for treating chronic infection in a human patient in need, CC and treating cancer in a human patient. XX SQ Sequence 218 AA; ALIGNMENT: Query Match 100.0%; Score 1129; Length 218; Best Local Similarity 100.0%; Matches 218; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 EIVLTQSPATLSLSPGERATLSCRASKGVSTSGYSYLHWYQQKPGQAPRLLIYLASYLES 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 EIVLTQSPATLSLSPGERATLSCRASKGVSTSGYSYLHWYQQKPGQAPRLLIYLASYLES 60 Qy 61 GVPARFSGSGSGTDFTLTISSLEPEDFAVYYCQHSRDLPLTFGGGTKVEIKRTVAAPSVF 120 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 61 GVPARFSGSGSGTDFTLTISSLEPEDFAVYYCQHSRDLPLTFGGGTKVEIKRTVAAPSVF 120 Qy 121 IFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLS 180 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 121 IFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLS 180 Qy 181 STLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 218 |||||||||||||||||||||||||||||||||||||| Db 181 STLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 218 Alignment with SEQ ID NO: 11 BKU69400 ID BKU69400 standard; protein; 447 AA. XX AC BKU69400; XX DT 19-MAY-2022 (first entry) XX DE Anti-human PD-1 antibody IgG4 heavy chain, SEQ: 10. XX KW MK-3475; PD-1 protein; Pembrolizumab; SCH 900475; antibody therapy; KW antimicrobial-gen.; cancer; cytostatic; heavy chain; humanized antibody; KW infectious disease; lambrolizumab; monoclonal antibody; KW programmed death receptor 1; prophylactic to disease; therapeutic. XX OS Homo sapiens. OS Synthetic. XX CC PN US2022089738-A1. XX CC PD 24-MAR-2022. XX CC PF 23-SEP-2021; 2021US-00482650. XX PR 24-SEP-2020; 2020US-0082888P. XX CC PA (MERI ) MERCK SHARP & DOHME CORP. XX CC PI Zhao X, Su Y, Forrest WP, Sangani SS, Mittal S, Krishnamachari Y; XX DR WPI; 2022-42866T/038. XX CC PT Formulation for treating chronic infection and cancer, comprises anti- CC PT human PD-1 antibody, or antigen binding fragment, PH20 variant or CC PT fragment, buffer, non-reducing dissacharide selected from sucrose and CC PT trehalose, non-ionic surfactant. XX CC PS Claim 46; SEQ ID NO 10; 65pp; English. XX CC The present invention relates to a stable formulation of antibodies CC against human programmed death receptor (PD-1), or antigen-binding CC fragments, and a PH20 variant or fragment. Formulation comprises about 20 CC -200 mg/mL of an anti-human PD-1 antibody, or antigen-binding fragment, CC about 0 .0009-0 .050 mg/ml of a PH20 variant or fragment, about 5-20 mM CC buffer, about 3-10 wt. percent non-reducing disaccharide selected from CC the group consisting of sucrose and trehalose, about 0 .005-0 .10 wt. CC percent non-ionic surfactant, and optionally about 1 mM to about 30 mM CC antioxidant. The invention further discloses: (1) a method of treating CC chronic infection in a human patient in need, which involves CC administering an effective amount of the formulation to the patient; (2) CC a method of treating cancer in a human patient, which involves CC administering an effective amount of the formulation to the patient. The CC formulation for treating chronic infection in a human patient in need, CC and treating cancer in a human patient. XX SQ Sequence 447 AA; ALIGNMENT: Query Match 100.0%; Score 2383; Length 447; Best Local Similarity 100.0%; Matches 445; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 2 VQLVQSGVEVKKPGASVKVSCKASGYTFTNYYMYWVRQAPGQGLEWMGGINPSNGGTNFN 61 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 2 VQLVQSGVEVKKPGASVKVSCKASGYTFTNYYMYWVRQAPGQGLEWMGGINPSNGGTNFN 61 Qy 62 EKFKNRVTLTTDSSTTTAYMELKSLQFDDTAVYYCARRDYRFDMGFDYWGQGTTVTVSSA 121 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 62 EKFKNRVTLTTDSSTTTAYMELKSLQFDDTAVYYCARRDYRFDMGFDYWGQGTTVTVSSA 121 Qy 122 STKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG 181 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 122 STKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG 181 Qy 182 LYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVF 241 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 182 LYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVF 241 Qy 242 LFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYR 301 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 242 LFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYR 301 Qy 302 VVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKN 361 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 302 VVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKN 361 Qy 362 QVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGN 421 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 362 QVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGN 421 Qy 422 VFSCSVMHEALHNHYTQKSLSLSLG 446 ||||||||||||||||||||||||| Db 422 VFSCSVMHEALHNHYTQKSLSLSLG 446 Alignment with SEQ ID NO: 5 BKU69395 ID BKU69395 standard; protein; 218 AA. XX AC BKU69395; XX DT 19-MAY-2022 (first entry) XX DE Anti-human PD-1 antibody IgG4 light chain, SEQ: 5. XX KW MK-3475; PD-1 protein; Pembrolizumab; SCH 900475; antibody therapy; KW antimicrobial-gen.; cancer; cytostatic; humanized antibody; KW infectious disease; lambrolizumab; light chain; monoclonal antibody; KW programmed death receptor 1; prophylactic to disease; therapeutic. XX OS Homo sapiens. OS Synthetic. XX CC PN US2022089738-A1. XX CC PD 24-MAR-2022. XX CC PF 23-SEP-2021; 2021US-00482650. XX PR 24-SEP-2020; 2020US-0082888P. XX CC PA (MERI ) MERCK SHARP & DOHME CORP. XX CC PI Zhao X, Su Y, Forrest WP, Sangani SS, Mittal S, Krishnamachari Y; XX DR WPI; 2022-42866T/038. XX CC PT Formulation for treating chronic infection and cancer, comprises anti- CC PT human PD-1 antibody, or antigen binding fragment, PH20 variant or CC PT fragment, buffer, non-reducing dissacharide selected from sucrose and CC PT trehalose, non-ionic surfactant. XX CC PS Claim 46; SEQ ID NO 5; 65pp; English. XX CC The present invention relates to a stable formulation of antibodies CC against human programmed death receptor (PD-1), or antigen-binding CC fragments, and a PH20 variant or fragment. Formulation comprises about 20 CC -200 mg/mL of an anti-human PD-1 antibody, or antigen-binding fragment, CC about 0 .0009-0 .050 mg/ml of a PH20 variant or fragment, about 5-20 mM CC buffer, about 3-10 wt. percent non-reducing disaccharide selected from CC the group consisting of sucrose and trehalose, about 0 .005-0 .10 wt. CC percent non-ionic surfactant, and optionally about 1 mM to about 30 mM CC antioxidant. The invention further discloses: (1) a method of treating CC chronic infection in a human patient in need, which involves CC administering an effective amount of the formulation to the patient; (2) CC a method of treating cancer in a human patient, which involves CC administering an effective amount of the formulation to the patient. The CC formulation for treating chronic infection in a human patient in need, CC and treating cancer in a human patient. XX SQ Sequence 218 AA; ALIGNMENT: Query Match 100.0%; Score 1129; Length 218; Best Local Similarity 100.0%; Matches 218; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 EIVLTQSPATLSLSPGERATLSCRASKGVSTSGYSYLHWYQQKPGQAPRLLIYLASYLES 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 EIVLTQSPATLSLSPGERATLSCRASKGVSTSGYSYLHWYQQKPGQAPRLLIYLASYLES 60 Qy 61 GVPARFSGSGSGTDFTLTISSLEPEDFAVYYCQHSRDLPLTFGGGTKVEIKRTVAAPSVF 120 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 61 GVPARFSGSGSGTDFTLTISSLEPEDFAVYYCQHSRDLPLTFGGGTKVEIKRTVAAPSVF 120 Qy 121 IFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLS 180 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 121 IFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLS 180 Qy 181 STLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 218 |||||||||||||||||||||||||||||||||||||| Db 181 STLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 218 Application/Control Number: 18/484,631 Page 2 Art Unit: 1646 Application/Control Number: 18/484,631 Page 3 Art Unit: 1646 Application/Control Number: 18/484,631 Page 4 Art Unit: 1646 Application/Control Number: 18/484,631 Page 5 Art Unit: 1646 Application/Control Number: 18/484,631 Page 6 Art Unit: 1646 Application/Control Number: 18/484,631 Page 7 Art Unit: 1646 Application/Control Number: 18/484,631 Page 8 Art Unit: 1646 Application/Control Number: 18/484,631 Page 9 Art Unit: 1646 Application/Control Number: 18/484,631 Page 10 Art Unit: 1646 Application/Control Number: 18/484,631 Page 11 Art Unit: 1646 Application/Control Number: 18/484,631 Page 12 Art Unit: 1646 Application/Control Number: 18/484,631 Page 13 Art Unit: 1646 Application/Control Number: 18/484,631 Page 14 Art Unit: 1646 Application/Control Number: 18/484,631 Page 15 Art Unit: 1646 Application/Control Number: 18/484,631 Page 16 Art Unit: 1646 Application/Control Number: 18/484,631 Page 17 Art Unit: 1646 Application/Control Number: 18/484,631 Page 18 Art Unit: 1646 Application/Control Number: 18/484,631 Page 19 Art Unit: 1646 Application/Control Number: 18/484,631 Page 20 Art Unit: 1646 Application/Control Number: 18/484,631 Page 21 Art Unit: 1646 Application/Control Number: 18/484,631 Page 22 Art Unit: 1646 Application/Control Number: 18/484,631 Page 23 Art Unit: 1646 Application/Control Number: 18/484,631 Page 24 Art Unit: 1646 Application/Control Number: 18/484,631 Page 25 Art Unit: 1646
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