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 .
Claim Status
Claims 52, 58-61, 77-82, 86, and 88-91 are pending.
Claim 52 is amended and claim 91 are new.
Claims 1-51, 53-57, 62-76, 83-85, and 87 are cancelled.
Claims 52, 58-61, 77-82, 86, and 88-91 have been examined.
Priority
This application is a CON of 16/868,693 05/07/2020 PAT 11273142
16/868,693 is a CON of 15/403,675 01/11/2017 PAT 10646463
16/868,693 has PRO 62/395,446 09/16/2016
16/868,693 has PRO 62/393,929 09/13/2016
16/868,693 has PRO 62/277,293 01/11/2016
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/06/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Withdrawn Rejection
The provisional rejection of claims 52, 58-61, 77-81, and 91 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of copending Application No. 17/682,165 (the ‘165 application) in view of Petersen et al. in view of Joharapurkar et al. and in view of Vergote et al. is withdrawn because the ‘165 application is canceled.
The provisional rejection of claims 52, 58-61, 77-81, and 83 on the ground of nonstatutory double patenting as being unpatentable over claim 11 of copending Application No. 18/846,365 (the ‘365 application) in view of Petersen et al. in view of Joharapurkar et al. and in view of Vergote et al. is withdrawn because claim 11 of the ‘365 application is canceled.
Modified Rejection
Claim Rejections - 35 USC § 103
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.
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.
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 52, 58-61, 77-81, and 91 are rejected under 35 U.S.C. 103 as being unpatentable over Petersen et al. (US 2014/0308235 A1, previously cited 9/1/2023) in view of Joharapurkar et al. (Diabetes Metab Syndr Obes. 2014;7:73-84, previously cited 5/7/2025) and Vergote et al. (British Journal of Cancer (2004) 90(Suppl 1), S11-S14, previously cited 9/1/2023).
A method of treating a metabolically-sensitive tumor in an obese human subject comprising administering to the obese subject:
at least one amount of at least one polymer conjugate, or a pharmaceutically acceptable salt thereof; and
at least one amount of fulvestrant wherein the metabolically-sensitive tumor is breast cancer tumor,
wherein the obese subject has at least one metabolic dysfunction selected from excessive visceral adiposity, elevated leptin levels, low adiponectin levels, a high leptin-to-adiponectin ratio or any combination thereof.
Petersen et al. teach the use of a polymer conjugated Methionine aminopeptidase 2 (MetAP2) inhibitor for improving insulin sensitivity and glycemic control, reducing insulin levels and/or improving leptin sensitivity (Abstract). Petersen et al. show the polymer conjugated
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Methionine aminopeptidase 2 [0048-0050; claim 1], reading on the elected species as follows. Petersen et al. teach the use of conjugate to treat over-weight or obese, impaired glucose tolerance, impaired fasting glucose, or insulin resistance syndrome [0212,0226]. Petersen et al. teach the treated patient or subject can mean either a human or non-human subject [0240]. Petersen et al. further suggest the beneficial use the polymer conjugate in a combination with a second active agent, e.g., an anticancer compound, [0230, 0256,0259] to treat breast or other cancers [0158] or tumor [0153], reading on the limitation (i) in claims 52 and 91.
Petersen et al. do not specify treatment of a patient with a metabolic dysfunction and breast cancer tumor further having metabolic dysfunction with one or more clinical symptoms of excessive visceral adiposity, elevated leptin levels, low adiponectin levels, and/or a high leptin-to-adiponectin ratio.
Similarly, Joharapurkar et al. teach the use of MetAP2 inhibitors as anti-angiogenic agents that prevent tumor vascularization and metastasis (p77, col 2, para 1, last two lines). Joharapurkar et al. teach obesity also increases the risk of breast cancer (p74, col 1, 3rd last line), reading on metabolically-sensitive tumor as breast cancer tumor. Joharapurkar et al. teach that leptin promotes angiogenesis and, on the other hand, adiponectin significantly suppresses angiogenesis (p75, col 2, para 2, last 3 lines). Joharapurkar et al. further teach administration of a methionine aminopeptidase 2 (MetAP2) inhibitor for the treatment of cancer and obesity by affecting antiangiogenesis (p79, col 2, para 1; p80, col 2, Clinical studies on MetAP2 modulators, para 1). Because both Petersen et al. and Joharapurkar et al. teach administering a MetAP2 inhibitor to treat both breast cancer and obesity by targeting to the same mechanism of angiogenesis, one of ordinary skill in the art would have found it obvious to treat an obese person with breast cancer tumor having elevated leptin levels, low adiponectin levels, and/or a high leptin-to-adiponectin ratio by inhibiting the angiogenesis pathway in the obese and cancer patient with Petersen’s MetAP2 inhibitor, reading on the wherein clause in claims 52 and 91.
Petersen et al. in view of Joharapurkar et al. suggest a combination therapy comprising Petersen’s MetAP2 inhibitor conjugate to treat a patient with a metabolic dysfunction and breast cancer tumor, but do not teach a combination therapy of a second anti-cancer compound of fulvestrant for treating a breast cancer tumor.
Vergote et al. teach “Fulvestrant is an effective and well-tolerated endocrine therapy for postmenopausal women with advanced breast cancer: results from clinical trials” (Title). Vergote et al. teach Fulvestrant (‘Faslodex’) is a new type of endocrine treatment – an oestrogen receptor (ER) antagonist that downregulates the ER and has no agonist effects (Abstract). Vergote et al. teach Fulvestrant is the only ER antagonist that has demonstrated unequivocal efficacy in patients with tamoxifen-resistant advanced breast cancer while other antioestrogens show limited efficacy (p514, col 2, para 2). Because Vergote et al. teach Fulvestrant is an effective and well-tolerated endocrine therapy to treat advanced breast cancer and Fulvestrant is the only ER antagonist that has demonstrated unequivocal efficacy in patients with tamoxifen-resistant advanced breast cancer, one of ordinary skill in the art before the effective filing date of this invention would have found it obvious to beneficially combine Petersen’s polymer conjugated MetAP2 inhibitor and Vergote’s Fulvestrant to treat a breast cancer tumor, reading on the limitation (ii) in claims 52 and 91.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine Petersen’s polymer conjugated MetAP2 inhibitor with Joharapurkar’s teaching of administering a methionine aminopeptidase 2 (MetAP2) inhibitor for the treatment of breast cancer tumor and obese patients because Joharapurkar et al. teach (a) obesity also increases the risk of breast cancer (p74, col 1, 3rd last line), (b) Joharapurkar et al. teach administering a MetAP2 inhibitor to treat both breast cancer and obesity by targeting to the same mechanism of angiogenesis (p79, col 2, para 1; p80, col 2, Clinical studies on MetAP2 modulators, para 1), and (c) Joharapurkar et al. suggest that leptin promotes angiogenesis and adiponectin significantly suppresses angiogenesis (p75, col 2, para 2, last 3 lines) and a methionine aminopeptidase 2 (MetAP2) inhibitor can inhibit angiogenesis for treating metabolically-sensitive breast cancer tumor in an obese patient by affecting antiangiogenesis (p79, col 2, para 1; p80, col 2, Clinical studies on MetAP2 modulators, para 1). The combination would have reasonable expectation of success because both references teach methionine aminopeptidase 2 (MetAP2) inhibitors can be used to treat both breast cancer and obesity by targeting to the same angiogenesis mechanism.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine Petersen et al. in view of Joharapurkar et al. and Vergote’s Fulvestrant because (a) Petersen et al. in view of Joharapurkar et al. teach administration of a polymer conjugated MetAP2 inhibitor in a combination a second anticancer agent to treat an obese person with breast cancer (Petersen et al. [0158]) or tumor (Petersen et al. [0153]), and (b)(i) Vergote et al. teach “Fulvestrant is an effective and well-tolerated endocrine therapy for postmenopausal women with advanced breast cancer: results from clinical trials” (Title) and (b)(ii) Vergote et al. further teach Fulvestrant is the only ER antagonist that has demonstrated unequivocal efficacy in patients with tamoxifen-resistant advanced breast cancer while other antioestrogens show limited efficacy (p514, col 2, para 2). The combination would have reasonable expectation of success because all references teach administration of an anti-cancer compound to treat breast cancer.
With respect to claim 58, Petersen et al. teach a second active agent may be co-administered sequentially or simultaneously [0232].
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With respect to claim 59, Petersen et al. suggest a second active agent may be administered sequentially [0232], suggesting the 2nd active agent administered either before the polymer conjugated MetAP2 inhibitor or after the polymer conjugated MetAP2 inhibitor.
With respect to claims 60-61, Petersen et al. show the polymer conjugated MetAP2 inhibitor treated obese patient having a metabolic dysfunction of Insulin resistance [228] and reduce elevated fasting insulin levels shown above [406; Fig 22].
With respect to claim 77, Petersen et al. teach x to y is in the range of about 30:1 to about 3:1 [0052].
With respect to claim 78, Petersen et al. teach the ratio of x to y is about 11:1 [0052].
With respect to claim 79, Petersen et al. teach the polymer conjugate administered 1 to 5 times per week, every three to four days, or less frequently [0267].
With respect to claim 80, Petersen et al. suggest a second active agent may also be conjugated to a polymer [0230]. Petersen et al. further suggest an active agent is administered at 15 mg/m2/day reading on one polymer conjugate administered at a dosage 15 mg/m2/day [0159].
With respect to claim 81, Petersen et al. teach the active agent is admixed under sterile conditions with a pharmaceutically acceptable carrier [0276].
Applicant’s Arguments
First, the Office has provided no objective reasoning as to why these cited portions of Petersen teach or suggest a polymer conjugate in combination with an anti-cancer compound (Remarks, p8, para 1-4).
Secondly, TNP-470 has been found to be too toxic and none of the disclosures of Petersen cited by the Office teach or suggest the claimed combination of the specific MetAP2 inhibitor and fulvestrant for a method of treating a metabolically sensitive tumor in an obese patient (Remarks, p8, last 3 para to p9, para 1-2).
(c) Joharapurkar (i) fails to teach or suggest MetAP2 inhibitors in combination with any chemotherapeutics, let alone the specific polymer conjugate and fulvestrant recited in instant claim 52, and (ii) is directed to the use of MetAP2 inhibitors in the treatment of obesity, not a metabolically sensitive tumor as claimed. Joharapurkar focus on "the anti-obesity efficacy of MetAP2 inhibitors ... at low doses that do not affect angiogenesis (Remarks, p9, last 2 para to p10, para 1-2).
(d) Vergote was merely cited as teaching the use of Fulvestrant in the treatment of breast
cancer. Vergote is silent as to the treatment of cancer in obese subjects and silent as to the use of Fulvestrant in combination with any other therapeutic, let alone the claimed polymer conjugate (Remarks, p10, para 3).
(e) The instantly claimed methods exhibit superior and unexpected properties shown in Examples 1 and 3 (Remarks, p10, last para to p11 1-3).
(f) Applicant submits that the claimed invention satisfies a long-felt but unmet need in the art which is objective indicia of nonobviousness (Remarks, p11, last para to p12, para 1).
Response to Arguments
Applicant's arguments filed 11/6/2025 have been fully considered but they are not persuasive because the arguments (a)-(d) above are based on arguing individual references separately by improperly limiting the teachings of a cited reference whereas the rejection is based on the combination of cited references as a whole described above.
Applicant’s argument (a) is not persuasive because Petersen et al. suggest the beneficial use the polymer conjugate in a combination with a second active agent, e.g., an anticancer compound, [0230, 0256,0259] to treat breast or other cancers [0158] or tumor [0153]. The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988). See MPEP 2144(I). A person of ordinary skill in the art is well defined as a person of ordinary creativity able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at ___, 82 USPQ2d at 1396. See MPEP 2141.03 (I). Since one of ordinary skill in the art as defined in MPEP is able to understand the beneficial use of Petersen’s prodrug conjugate [0048, 0050, claim 1] in combination with an anti-breast cancer compound to treat a human patient in need, the argument (a) of applicant’s opinion is not persuasive.
Applicant’s argument (b) is not persuasive because (i) Petersen et al. teach a polymer conjugated Methionine aminopeptidase 2 (MetAP2) inhibitor as a prodrug (claim 1), not free toxic TNP-470 compound as argued by applicant, in combination with an anti-breast cancer compound to treat a human patient in need and (ii) Vergote et al. teach “Fulvestrant is an effective and well-tolerated endocrine therapy for postmenopausal women with advanced breast cancer: results from clinical trials” (Title). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). SEE MPEP 2144.06(I).
Applicant’s argument (c) is not persuasive because (i) Joharapurkar et al. teach obesity also increases the risk of breast cancer (p74, col 1, 3rd last line), reading on metabolically-sensitive tumor as breast cancer tumor. Joharapurkar et al. teach that leptin promotes angiogenesis and, on the other hand, adiponectin significantly suppresses angiogenesis (p75, col 2, para 2, last 3 lines). Joharapurkar et al. further teach administration of a methionine aminopeptidase 2 (MetAP2) inhibitor for the treatment of cancer and obesity by affecting antiangiogenesis (p79, col 2, para 1; p80, col 2, Clinical studies on MetAP2 modulators, para 1) and (ii) a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005). See MPEP 2123(I). Because a person of ordinary skill in the art as defined in MPEP 2141.03 (I) able to fit the teachings of cited references of record together like pieces of a puzzle, the argument of a single reference of Joharapurkar et al. alone is persuasive. In particular, the dosage of an anticancer compound to treat a human patient is a result effective variable that can be determined by clinical trials well known in the art.
Applicant’s argument (d) is not persuasive because applicant argues a single reference of Vergote whereas the rejection is based on the combination of Petersen et al. in view of Joharapurkar et al. and Vergote et al. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). See MPEP 2143(IV).
Applicant’s argument (e) is not persuasive because the argument is not commensurate in the scope with the claims. The claims is drawn to administer Petersen’s prodrug conjugate AND Vergote’s fulvestrant to treat a human patient in need, not Petersen’s prodrug conjugate alone to treat mice in Examples 1 and 3 as argued by applicant. Furthermore, Petersen et al. suggest the beneficial use the polymer conjugate in a combination with a second active agent of an anticancer compound, [0230, 0256,0259] to treat breast or other cancers [0158]. Thus, it is expected that a combination of Petersen’s prodrug conjugate and Vergote et al. is capable to treat a general breast cancer patients as well as a subset breast cancer patients. Lastly, the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). See MPEP 716.02(b).
Applicant’s argument (f) is not persuasive because applicant’s evidence is insufficient to establish long-felt need requirement. According to MPEP 716.04, the claimed invention must satisfy a long-felt need which was recognized, persistent, and not solved by others. The combined prior art references of record provide a solution of administering a combination of Petersen’s prodrug conjugate AND Vergote’s fulvestrant to treat obesity of a breast cancer patient before the effective filing date of this invention.
2. Claims 52, 58-61, 77-82, 86, and 88-91 are rejected under 35 U.S.C. 103 as being unpatentable over Petersen et al. in view of Joharapurkar et al. and Vergote et al. as applied to claims 52, 58-61, 77-81, and further in view of Schwartzberg et al. (Clinical Breast Cancer, 2014; 14(1): 13-19, previously cited 9/1/2023).
Claim 82 is drawn to the treated cancer is HR+/Her2- breast cancer.
Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach a method of treating breast tumor of an obese patient as applied to claims 52, 58-61, 77-81, and 91 above.
Petersen et al. in view of Joharapurkar et al. and Vergote et al. do not teach the treated breast cancer genotype as HR+/Her2- in a postmenopausal woman patient.
Schwartzberg et al. teach the use of Fulvestrant in a combination therapy to treat Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer (Title). Schwartzberg et al. show the overall response frequencies after treatment of Fulvestrant (p16, Table 2). Because Schwartzberg et al. show HR+/Her2- breast cancer patients were successfully treated by a combination therapy comprising Fulvestrant, one of ordinary skill in the art before the effective filing date of this invention would have found it obvious to administer Petersen’s polymer conjugated MetAP2 inhibitor together with Vergote’s Fulvestrant to treat HR+/Her2- breast cancer/tumor patients as suggested by Schwartzberg et al., reading on claim 82.
With respect to claims 86 and 88-90, Petersen et al. teach the use of a polymer conjugated Methionine aminopeptidase 2 (MetAP2) inhibitor for improving insulin sensitivity and glycemic control, reducing insulin levels and/or improving leptin sensitivity (Abstract). Schwartzberg et al. teach HR+/Her2- breast cancer patients are postmenopausal women (p14, col 1, last para/Patients).
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Petersen et al. in view of Joharapurkar et al. and Vergote et al. with (ii) Schwartzberg’s HR+/Her2- breast cancer patients because (a) Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach a combination therapy comprising a polymer conjugated MetAP2 inhibitor and Fulvestrant to treat oestrogen hormone receptor (HR) positive breast cancer/tumor (Abstract of Vergote et al.) and (b) Schwartzberg et al. teach the use of Fulvestrant in a combination therapy to treat Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer (Title; p16, Table 2). The combination would have reasonable expectation of success because all references teach treatment of breast cancer patients.
Response to Arguments
Applicant's arguments filed 11/6/2025 have been fully considered but they are not persuasive. See response to arguments above.
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 52, 58-61, 77-81, and 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5, 21-22, 27, 49, 56, and 58 of U.S. Patent No. 9,173,956 B2 (the ‘956 patent) in view of Petersen et al. in view of Joharapurkar et al. and
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Vergote et al.
Claim 2 of the ‘956 patent disclosed a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety W shown as follows.
Claim 3 of the ‘956 patent disclosed R4 is methyl.
Claim 4 of the ‘956 patent disclosed R5 is methyl.
Claim 5 of the ‘956 patent disclosed R6 is 2-hydroxypropyl.
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Claim 58 of the ‘956 patent disclosed Z moiety as follows.
Claims 2-5 and 58 of the ‘956 patent do not teach administration of the polymer conjugate of methionine aminopeptidase-2 inhibitor to treat breast cancer tumor.
The relevancy of Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach a method of treating an obese patient with breast cancer tumor as applied to claims 52, 58-61, 77-81, and 91 above not repeated here.
Because Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach beneficial use of a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety disclosed by claims 2-5 and 58 of the ‘956 patent in a combination of fulvestrant to treat an obese patient with breast cancer tumor, one of ordinary skill in the art would have found it obvious to beneficially combine claims 2-5 and 58 of the ‘956 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al.
Thus, claims 2-5 and 58 of the ‘956 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52 and 91.
Claim 21 of the ‘956 patent disclosed the ratio of x to y in the range of 20:1 to 4:1, satisfying the instant claim 77.
Claim 22 of the ‘956 patent disclosed the ratio of x to y is about 11:1, satisfying the instant claim 78.
Claim 49 of the ‘956 patent disclosed the compound is administered from about 1 to about 5 times per week, satisfying the instant claim 79.
Claim 56 of the ‘956 patent disclosed a composition comprising the polymer conjugate and a pharmaceutically acceptable carrier, satisfying the instant claim 81.
Claim 27 of the ‘956 patent disclosed the treated subject has two obesity-induced or obesity-related co-morbidities, satisfying the instant claim 83.
Thus, claims 2-5, 21-22, 27, 49, 56, and 58 of the ‘956 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52, 58-61, 77-81, and 83.
Response to Arguments
Applicant's arguments filed 11/6/2025 have been fully considered but they are not persuasive because the argument is not applied to the modified rejection. See response to arguments above.
Claims 52, 58-61, 77-81, and 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5, 21-22, 27, 40, 48, and 50 of U.S. Patent No. 9,433,600 B2 (the ‘600 patent) in view of Petersen et al. in view of Joharapurkar et al. and Vergote et al.
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Claim 2 of the ‘600 patent disclosed a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety W shown as follows.
Claim 3 of the ‘600 patent disclosed R4 is methyl.
Claim 4 of the ‘600 patent disclosed R5 is methyl.
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Claim 5 of the ‘600 patent disclosed R6 is 2-hydroxypropyl.
Claim 50 of the ‘600 patent disclosed Z moiety as follows.
Claims 2-5 and 50 of the ‘600 patent do not teach administration of the polymer conjugate of methionine aminopeptidase-2 inhibitor to treat breast cancer tumor.
The relevancy of Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach a method of treating an obese patient with breast cancer tumor as applied to claims 52, 58-61, 77-81, and 91 above not repeated here.
Because Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach beneficial use of a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety disclosed by claims 2-5 and 50 of the ‘600 patent in a combination of fulvestrant to treat an obese patient with breast cancer tumor, one of ordinary skill in the art would have found it obvious to beneficially combine claims 2-5 and 50 of the ‘600 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al.
Thus, claims 2-5 and 50 of the ‘600 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52 and 91.
Claim 21 of the ‘600 patent disclosed the ratio of x to y in the range of 20:1 to 4:1, satisfying the instant claim 77.
Claim 22 of the ‘600 patent disclosed the ratio of x to y is about 11:1, satisfying the instant claim 78.
Claim 40 of the ‘600 patent disclosed the compound is administered from about 1 to about 5 times per week, satisfying the instant claim 79.
Claim 48 of the ‘600 patent disclosed a composition comprising the polymer conjugate and a pharmaceutically acceptable carrier, satisfying the instant claim 81.
Thus, claims 2-5, 21-22, 27, 40, 48, and 50 of the ‘600 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52, 58-61, 77-81, and 91.
Response to Arguments
Applicant's arguments filed 11/6/2025 have been fully considered but they are not persuasive because the argument is not applied to the modified rejection. See response to arguments above.
Claims 52, 58-61, 77-81, and 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5, 21-22, 27, 40, 48, and 50 of U.S. Patent No. 9,750,737 B2 (the ‘737 patent) in view of Petersen et al. in view of Joharapurkar et al. and Vergote et al.
Claim 2 of the ‘737 patent disclosed a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety.
Claim 3 of the ‘737 patent disclosed R4 is methyl.
Claim 4 of the ‘737 patent disclosed R5 is methyl.
Claim 5 of the ‘737 patent disclosed R6 is 2-hydroxypropyl.
Claim 50 of the ‘737 patent disclosed Z moiety as follows.
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Claims 2-5 and 50 of the ‘737 patent do not teach administration of the polymer conjugate of methionine aminopeptidase-2 inhibitor to treat cancer.
The relevancy of Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach a method of treating an obese patient with breast cancer tumor as applied to claims 52, 58-61, 77-81, and 91 above not repeated here.
Because Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach beneficial use of a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety disclosed by claims 2-5 and 50 of the ‘737 patent in a combination of fulvestrant to treat an obese patient with breast cancer tumor, one of ordinary skill in the art would have found it obvious to beneficially combine claims 2-5 and 50 of the ‘737 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al.
Thus, claims 2-5 and 50 of the ‘737 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52 and 91.
Claim 27 of the ‘737 patent disclosed the treated patient having insulin resistance syndrome, satisfying the instant claim 60.
Claim 21 of the ‘737 patent disclosed the ratio of x to y in the range of 20:1 to 4:1, satisfying the instant claim 77.
Claim 22 of the ‘737 patent disclosed the ratio of x to y is about 11:1, satisfying the instant claim 78.
Claim 40 of the ‘737 patent disclosed the compound is administered from about 1 to about 5 times per week, satisfying the instant claim 79.
Claim 48 of the ‘737 patent disclosed a composition comprising the polymer conjugate and a pharmaceutically acceptable carrier, satisfying the instant claim 81.
Thus, claims 2-5, 21-22, 27, 40, 48, and 50 of the ‘737 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52, 58-61, 77-81, and 91.
Response to Arguments
Applicant's arguments filed 11/6/2025 have been fully considered but they are not persuasive because the argument is not applied to the modified rejection. See response to arguments above.
Claims 52, 58-61, 77-81, and 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5, 20-21, 26, 40, 48, and 55-56 of U.S. Patent No. 9,757, 373 B2 (the ‘373 patent) in view of Petersen et al. in view of Joharapurkar et al. and Vergote et al.
Claim 2 of the ‘373 patent disclosed a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety W.
Claim 3 of the ‘373 patent disclosed R4 is methyl.
Claim 4 of the ‘373 patent disclosed R5 is methyl.
Claim 5 of the ‘373 patent disclosed R6 is 2-hydroxypropyl.
Claim 56 of the ‘373 patent disclosed Z moiety as follows
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Claims 2-5 and 56 of the ‘373 patent do not teach administration of the polymer conjugate of methionine aminopeptidase-2 inhibitor to treat breast cancer tumor.
The relevancy of Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach a method of treating an obese patient with breast cancer tumor as applied to claims 52, 58-61, 77-81, and 91 above not repeated here.
Because Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach beneficial use of a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety disclosed by claims 2-5 and 56 of the ‘373 patent in a combination of fulvestrant to treat an obese patient with breast cancer tumor, one of ordinary skill in the art would have found it obvious to beneficially combine claims 2-5 and 56 of the ‘373 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al.
Thus, claims 2-5 and 56 of the ‘373 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52 and 91.
Claim 28 of the ‘373 patent disclosed the treated patient having insulin resistance syndrome, satisfying the instant claim 60.
Claim 20 of the ‘373 patent disclosed the ratio of x to y in the range of 20:1 to 4:1, satisfying the instant claim 77.
Claim 21 of the ‘373 patent disclosed the ratio of x to y is about 11:1, satisfying the instant claim 78.
Claim 48 of the ‘373 patent disclosed the compound is administered from about 1 to about 5 times per week, satisfying the instant claim 79.
Claim 55 of the ‘373 patent disclosed a composition comprising the polymer conjugate and a pharmaceutically acceptable carrier, satisfying the instant claim 81.
Thus, claims 2-5, 20-21, 26, 40, 48, and 55-56 of the ‘373 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. are obvious to the instant claims 52, 58-61, 77-81, and 91.
Response to Arguments
Applicant's arguments filed 11/6/2025 have been fully considered but they are not persuasive because the argument is not applied to the modified rejection. See response to arguments above.
Claims 52, 58-61, 77-81, and 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5, 20-21, 26, 39, 47, and 49 of U.S. Patent No. 10,010,544 B2 (the ‘544 patent) in view of Petersen et al. in view of Joharapurkar et al. and in view of Vergote et al..
Claim 2 of the ‘544 patent disclosed a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety W.
Claim 3 of the ‘544 patent disclosed R4 is methyl.
Claim 4 of the ‘544 patent disclosed R5 is methyl.
Claim 5 of the ‘544 patent disclosed R6 is 2-hydroxypropyl.
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Claim 49 of the ‘544 patent disclosed Z moiety as follows.
Claims 2-5 and 49 of the ‘544 patent do not teach administration of the polymer conjugate of methionine aminopeptidase-2 inhibitor to treat breast cancer tumor.
The relevancy of Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach a method of treating an obese patient with breast cancer tumor as applied to claims 52, 58-61, 77-81, and 91 above not repeated here.
Because Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach beneficial use of a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety disclosed by claims 2-5 and 49 of the ‘544 patent in a combination of fulvestrant to treat an obese patient with breast cancer tumor, one of ordinary skill in the art would have found it obvious to beneficially combine claims 2-5 and 49 of the ‘544 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al.
Thus, claims 2-5 and 49 of the ‘544 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52 and 91.
Claim 26 of the ‘544 patent disclosed the treated patient having insulin resistance syndrome, satisfying the instant claim 60.
Claim 20 of the ‘544 patent disclosed the ratio of x to y in the range of 20:1 to 4:1, satisfying the instant claim 77.
Claim 21 of the ‘544 patent disclosed the ratio of x to y is about 11:1, satisfying the instant claim 78.
Claim 39 of the ‘544 patent disclosed the compound is administered from about 1 to about 5 times per week, satisfying the instant claim 79.
Claim 47 of the ‘544 patent disclosed a composition comprising the polymer conjugate and a pharmaceutically acceptable carrier, satisfying the instant claim 81.
Response to Arguments
Applicant's arguments filed 11/6/2025 have been fully considered but they are not persuasive because the argument is not applied to the modified rejection. See response to arguments above.
Claims 52, 58-61, 77-81, and 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5, 20-21, 26, 36, 44, and 46 of U.S. Patent No. 10,588,904 B2 (the ‘904 patent) in view of Petersen et al. in view of Joharapurkar et al. and in view of Vergote et al..
Claim 2 of the ‘904 patent disclosed a polymer conjugate of methionine aminopeptidase 2 inhibitor moiety W.
Claim 3 of the ‘904 patent disclosed R4 is methyl.
Claim 4 of the ‘904 patent disclosed R5 is methyl.
Claim 5 of the ‘904 patent disclosed R6 is 2-hydroxypropyl.
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Claim 46 of the ‘904 patent disclosed Z moiety as follows.
Claims 2-5 and 46 of the ‘904 patent do not teach administration of the polymer conjugate of methionine aminopeptidase-2 inhibitor to treat breast cancer.
The relevancy of Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach a method of treating an obese patient with breast cancer tumor as applied to claims 52, 58-61, 77-81, and 91 above not repeated here.
Because Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach beneficial use of a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety disclosed by claims 2-5 and 46 of the ‘904 patent in a combination of fulvestrant to treat an obese patient with breast cancer tumor, one of ordinary skill in the art would have found it obvious to beneficially combine claims 2-5 and 46 of the ‘904 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al.
Thus, claims 2-5 and 46 of the ‘904 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52 and 91.
Claim 26 of the ‘904 patent disclosed the treated patient having insulin resistance syndrome, satisfying the instant claim 60.
Claim 20 of the ‘904 patent disclosed the ratio of x to y in the range of 20:1 to 4:1, satisfying the instant claim 77.
Claim 21 of the ‘904 patent disclosed the ratio of x to y is about 11:1, satisfying the instant claim 78.
Claim 36 of the ‘904 patent disclosed the compound is administered from about 1 to about 5 times per week, satisfying the instant claim 79.
Claim 44 of the ‘904 patent disclosed a composition comprising the polymer conjugate and a pharmaceutically acceptable carrier, satisfying the instant claim 81.
Thus, claims 2-5, 20-21, 26, 36, 44, and 46 of the ‘904 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52, 58-61, 77-81, and 91.
Response to Arguments
Applicant's arguments filed 11/6/2025 have been fully considered but they are not persuasive because the argument is not applied to the modified rejection. See response to arguments above.
Claims 52, 58-61, 77-81, and 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 22-24, 27 and 34-35 of U.S. Patent No. 10,646,463 B2 (the ‘463 patent) in view of Petersen et al. in view of Joharapurkar et al. and in view of Vergote et al..
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Claim 1 of the ‘463 patent disclosed a method of administering a polymer conjugate of methionine aminopeptidase 2 (MetAP2) inhibitor for treating post-menopausal HR+/Her2- breast cancer patient having one or more metabolic dysfunction comprising insulin resistance shown above.
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Claim 2 of the ‘463 patent disclosed z moiety as follows.
Claim 34 of the ‘463 patent disclosed the method further comprising a second active agent.
Claims 1-2 and 34 of the ‘463 patent do not explicitly teach the second active agent as fulvestrant.
The relevancy of Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach a method of treating an obese patient with breast cancer tumor as applied to claims 52, 58-61, 77-81, and 91 above not repeated here.
Because Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach beneficial use of a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety disclosed by claims 1-2 and 34 of the ‘463 patent in a combination of fulvestrant to treat an obese patient with breast cancer tumor, one of ordinary skill in the art would have found it obvious to beneficially combine claims 1-2 and 34 of the ‘463 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al.
Thus, claims 1-2 and 34 of the ‘463 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52 and 91.
Claim 22 of the ‘463 patent disclosed the ratio of x to y in the range of 30:1 to 3:1, satisfying the instant claim 77.
Claim 23 of the ‘463 patent disclosed the ratio of x to y is about 11:1, satisfying the instant claim 78.
Claim 24 of the ‘463 patent disclosed the method increases adiponectin, reading on the treated subject has low adiponectin levels and satisfying the instant claim 60.
Claim 27 of the ‘463 patent disclosed the compound is administered from about 1 to about 5 times per week, satisfying the instant claim 79.
Claim 35 of the ‘463 patent disclosed a composition comprising the polymer conjugate and a pharmaceutically acceptable carrier, satisfying the instant claim 81.
Thus, claims 1-2, 22-24, 27 and 34-35 of the ‘463 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52, 58-61, 77-81, and 91.
Response to Arguments
Applicant's arguments filed 11/6/2025 have been fully considered but they are not persuasive because the argument is not applied to the modified rejection. See response to arguments above.
Claims 52, 58-61, 77-81, and 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 10-14, 18, and 37-38 of U.S. Patent No. 11,273,142 B2 (the ‘142 patent) in view of Petersen et al. in view of Joharapurkar et al. and in view of Vergote et al..
Claim 1 of the ‘142 patent disclosed a method of treating cancer comprising administration of a polymer conjugate of a Methionine aminopeptidase 2 (MetAP2) inhibitor.
Claim 4 of the ‘142 patent disclosed the treated cancer patient having obesity.
Claims 7 and 10 of the ‘142 patent disclosed the method further comprising administration of a second active agent of fulvestrant.
Claim 18 of the ‘142 patent disclosed a compound reading on the elected species of MetAP2 inhibitor.
Claims 1,4, 7, 10, and 18 of the ‘142 patent the use of the combination to treat breast cancer tumor.
The relevancy of Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach a method of treating an obese patient with breast cancer tumor as applied to claims 52, 58-61, 77-81, and 91 above not repeated here.
Because Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach beneficial use of a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety disclosed by claims 1,4, 7, 10, and 18 of the ‘142 patent in a combination of fulvestrant to treat an obese patient with breast cancer tumor, one of ordinary skill in the art would have found it obvious to beneficially combine claims 1,4, 7, 10, and 18 of the ‘142 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al.
Thus, claims 1,4, 7, 10, and 18 of the ‘142 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52 and 91.
Claim 11 of the ‘142 patent disclosed the second agent (Fulvestrant in claim 7) are administered sequentially or in a substantially simultaneous manner, satisfying the instant claim 58.
Claim 11 of the ‘142 patent disclosed a composition comprising the polymer conjugate and a pharmaceutically acceptable salt, further satisfying the instant claim 81.
Claim 12 of the ‘142 patent disclosed the second active agent is administered at a time point after the administration of the at least one polymer conjugate, satisfying the instant claim 59.
Claims 13-14 of the ‘142 patent disclosed the treated subject having a metabolic dysfunction of elevated fasting insulin levels, satisfying the instant claims 60-61.
Claim 37 of the ‘142 patent disclosed the ratio of x:y from about 30:1 to 3:1, satisfying the instant claim 77.
Claim 38 of the ‘142 patent disclosed the ratio of x:y is about 11:1, satisfying the instant claim 78.
Thus, claims 1, 4, 7, 10-14, 18, and 37-38 of the ‘142 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52, 58-61, 77-81, and 91.
Response to Arguments
Applicant's arguments filed 11/6/2025 have been fully considered but they are not persuasive because the argument is not applied to the modified rejection. See response to arguments above.
Claims 52, 58-61, 77-81, and 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5, 12-13, 18, 31, 39, and 41 of U.S. Patent No. 11,304,944 B2 (the ‘944 patent) in view of Petersen et al. in view of Joharapurkar et al. and in view of Vergote et al..
Claim 2 of the ‘944 patent disclosed a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety W.
Claim 3 of the ‘944 patent disclosed R4 is methyl.
Claim 4 of the ‘944 patent disclosed R5 is methyl.
Claim 5 of the ‘944 patent disclosed R6 is 2-hydroxypropyl.
Claim 41 of the ‘944 patent disclosed Z moiety as follows.
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Claims 2-5 and 41 of the ‘944 patent do not teach administration of the polymer conjugate of methionine aminopeptidase-2 inhibitor to treat breast cancer tumor.
The relevancy of Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach a method of treating an obese patient with breast cancer tumor as applied to claims 52, 58-61, 77-81, and 91 above not repeated here.
Because Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach beneficial use of a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety disclosed by claims 2-5 and 41 of the ‘944 patent in a combination of fulvestrant to treat an obese patient with breast cancer tumor, one of ordinary skill in the art would have found it obvious to beneficially combine claims 2-5 and 41 of the ‘944 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al.
Claim 18 of the ‘944 patent disclosed the treated patient having insulin resistance syndrome, satisfying the instant claim 60.
Claim 12 of the ‘944 patent disclosed the ratio of x to y in the range of 20:1 to 4:1, satisfying the instant claim 77.
Claim 13 of the ‘944 patent disclosed the ratio of x to y is about 11:1, satisfying the instant claim 78.
Claim 31 of the ‘944 patent disclosed the compound administered from about 1 to about 5 times per week, satisfying the instant claim 79.
Claim 39 of the ‘944 patent disclosed a pharmaceutical composition comprising said compound and a pharmaceutically acceptable carrier, satisfying the instant claim 81.
Thus, claims 2-5, 12-13, 18, 31, 39, and 41 of the ‘944 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52, 58-61, 77-81, and 91.
Response to Arguments
Applicant's arguments filed 11/6/2025 have been fully considered but they are not persuasive because the argument is not applied to the modified rejection. See response to arguments above.
Claims 52, 58-61, 77-82, 86, and 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11-14 of U.S. Patent No. 11,612,577 B2 (the ‘577 patent) in view of Petersen et al. in view of Joharapurkar et al. and in view of Vergote et al..
Claim 1 of the ‘577 patent disclosed a combination therapy comprising administration a polymer conjugate (the elected species) together with a second active agent to treat cancer.
Claim 12 of the ‘577 patent disclosed the treated cancer is breast cancer.
Claims 1 and 12 of the ‘577 patent do not explicitly teach the treated patient having a metabolic dysfunction as claimed.
The relevancy of Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach a method of treating an obese patient with breast cancer tumor as applied to claims 52, 58-61, 77-81, and 91 above not repeated here.
Because Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach beneficial use of a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety disclosed by claims 1 and 12 of the ‘577 patent in a combination of fulvestrant to treat an obese patient with breast cancer tumor, one of ordinary skill in the art would have found it obvious to beneficially combine claims 1 and 12 of the ‘577 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al.
Claim 1 of the ‘577 patent disclosed the ration of x to y as 15: 1 (450:30), satisfying the instant claims 77-78.
Claims 11 and 13 of the ‘577 patent disclosed the treated cancers comprising HR+/Her- breast cancer, satisfying the instant claim 82.
Claim 14 of the ‘577 patent suggested the treated breast cancer patient being postmenopausal woman, satisfying the instant claim 86.
Thus, claims 1 and 11-14 of the ‘577 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52, 58-61, 77-82, 86, and 91.
Response to Arguments
Applicant's arguments filed 11/6/2025 have been fully considered but they are not persuasive because the argument is not applied to the modified rejection. See response to arguments above.
Claims 52, 58-61, 77-81, and 91 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-6 of U.S. Patent No. 12,419,846 B2 (the ‘846 patent, previously rejected as 18/119,628) in view of Petersen et al. in view of Joharapurkar et al. and in view of Vergote et al.
Claim 1 of the ‘628 application disclosed administration of an anticancer polymer conjugate of MetAP2 inhibitor to treat breast cancer.
Claim 1 of the ‘846 patent do not teach the polymer conjugate of MetAP2 inhibitor able to treat a patient with at least one metabolic dysfunction as claimed.
The relevancy of Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach a method of treating an obese patient with breast cancer tumor as applied to claims 52, 58-61, 77-81, and 91 above not repeated here.
Because Petersen et al. in view of Joharapurkar et al. and Vergote et al. teach beneficial use of a polymer conjugate of methionine aminopeptidase-2 inhibitor moiety disclosed by claim 1 of the ‘628 application in a combination of fulvestrant to treat an obese patient with breast cancer tumor, one of ordinary skill in the art would have found it obvious to beneficially combine claim 1 of the ‘846 patent with Petersen et al. in view of Joharapurkar et al. and Vergote et al.
Claim 5 of the ‘628 application disclosed the ratio of x to y is in the range of about 30: 1 to about 3:1, satisfying the instant claim 77.
Claim 6 of the ‘628 application disclosed the ratio of x to y is in the range of about 11: 1, satisfying the instant claim 78.
Claim 19 of the ‘628 application disclosed the treated cancer as post-menopausal HR+/Her2- breast cancer, further satisfying the instant claims 82, 86, and 90.
Thus, claims 1 and 5-6 of the ‘628 application in view of Petersen et al. in view of Joharapurkar et al. and Vergote et al. is obvious to the instant claims 52, 58-61, 77-81, and 91.
Response to Arguments
Applicant's arguments filed 11/6/2025 have been fully considered but they are not persuasive because the argument is not applied to the modified rejection. See response to arguments above.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.L/Examiner, Art Unit 1658
16-January-2026
/LI N KOMATSU/Primary Examiner, Art Unit 1658