DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a U.S. national phase of International Application No. PCT/US2021/056681, filed on 10/26/2021, which claims domestic benefit to US provision application 63105772, filed 10/26/2020.
Claim Status
The amendment, filed on 09/14/2023, in which claim 1 is amended and claims 2-3, 8, 19-20, 28, 31, 33-36, 38, 44, 46-47, and 49-54 are canceled, is acknowledged. Claims 1, 4-7, 9-18, 21-27, 29-30, 32, 37, 39-43, 45 and 48 are pending in the instant application and are examined on the merits herein.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/18/2023 and 01/07/2025 have been considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
“refereince” should read “reference” (pg. 1, line 12)
Repeated word “comprises” should be deleted (pg. 3, line 7)
“aboiut” should read “about” (pg. 3, line 22 and 25)
“intraveneously” should read “intravenously” (pg. 4, line 16)
“chemocherapy” should read “chemotherapy” (pg. 5, line 27)
Misspellings of melanoma should be corrected: “melamona” (pg. 6, line 10), “melanma” (pg. 12, line 18), “melanom” (pg. 12, line 21; pg. 75, line 14), “melanona" (pg. 58, line 7), “melanomais metastatic” (pg. 68, line 23; pg. 70, line 17)
“immunosorbant” should read “immunosorbent” (pg. 9, line 20; pg. 91, line 9)
“fomr” should read “from” (pg. 10, line 31)
“protiem” should read “protein” (pg. 11, line 23)
“can verified” should read “can be verified” (pg. 21, line 3)
“oculular” should read “ocular” (pg. 27, line 32)
“half lives” should be hyphenated (pg. 28, line 16; pg. 110, line 33)
“antibodes” should read “antibodies” (pg. 30, line 13)
“etc” should have a period “etc.” (pg. 49, lines 5 and 6)
“e.g,” should have a period “e.g.,” (pg. 55, line 4)
“very” should read “every” (pg. 57, line 19)
“furthe" should read “further” (pg. 27, line 26)
“dexcribed” should read “described” (pg. 62, line 13)
“Examplary” should read “Exemplary” (pg. 63, line 3)
“xeongrafts” should read “xenografts” (pg. 63, line 3)
Space missing between “Westernblot” (pg. 69, line 24)
“positvie" should read “positive” (pg. 69, line 28)
“Minaturization” should read “Miniaturization” (pg. 69, line 34)
Repeated word “or” should be deleted (pg. 70, line 9)
Space missing between “melanomapatient” (pg. 70, line 30)
Space missing between “hereincomprise” (pg. 75, line 16)
Space missing between “choroid.In” (pg. 77, line 23)
“The practice of the present invention are employ” is improper grammar (pg. 86, line 2)
Space missing between “aSyngeneic” (pg. 94, line 9)
“checkpoing” should read “checkpoint” (pg. 101, line 26)
“approvided” should read “approved” (pg. 101, line 26)
“evernts” should read “events” (pg. 103, last box)
Space missing between “PD-1using” (pg. 108, line 25)
“eg” should read “e.g.” (pg. 126, line 20; pg. 149, lines 2, 4, 8, and 17-19; pg. 154, lines 21 and 25; pg. 106, lines 8 and 21)
Repeated word “a” should be deleted (pg. 127, line 4)
Space missing between “andadministration” (pg. 140, Table 33)
Space missing between “andmediastinal” (pg. 141, Table 33)
Space missing between “andconnective” (pg. 141, Table 34)
“practise" should read “practice” (pg. 190, line 2)
“Table 47 belows” should read “Table 47 below” (pg. 212, line 3)
Appropriate correction is required.
The use of the terms:
“PicoKine” (pg. 9, line 21; pg. 91, line 10), “FlowJo” (pg. 10, line 12; pg. 87, line 15; pg. 90, line 4; pg. 167, line 17), “Afinitor” (pg. 59, line 3 and 4), “Arimidex” (pg. 59, line 5), “Aromasin” (pg. 59, line 5), “Ellence” (pg. 59, line 6), “Enhertu” (pg. 59, line 7), “Fareston” (pg. 59, line 9), “Faslodex” (pg. 59, line 9), “Femara” (pg. 59, line 9), “Herceptin” (pg. 59, line 12), “Ibrance” (pg. 59, line 12), “Ixempra” (pg. 59, line 12), “Kadcyla” (pg. 59, line 13), “Kisqali” (pg. 59, line 13), “Lynparza” (pg. 59, line 14), “Nerlynx” (pg. 59, line 14), “Perjeta” (pg. 59, line 16), “Piqray” (pg. 59, line 16), “Talzenna” (pg. 59, line 17), “Taxotere” (pg. 59, line 18), “Tecentriq” (pg. 59, line 18), “Trexall” (pg. 59, line 19), “Tykerb” (pg. 59, line 19), “Verzenio” (pg. 59, line 20), “Xeloda” (pg. 59, line 20), “Zoladex” (pg. 59, line 20), “Attune” (pg. 87, line 14), “ExiTron” (pg. 98, line 3; pg. 99, line 20), “OPDIVO” (pg. 133, Table 29 footnote; pg. 134, Table 30 footnote), “Abraxane” (pg. 186, line 9; pg. 187, lines 15, 25, 26, and 33; pg. 188, line 6; pg. 211, lines 21, 23, and 26; pg. 212, lines 1, 4, 7, 16, and Table 47; pg. 215, line 2) “Oncotype Dx” (pg. 194, line 31; pg. 203, line 21), and “EndoPredict” (pg. 194, line 31; pg. 203, line 21),
which are trade names or marks used in commerce, have been noted in this application. Each term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 13 and 30 are objected to because of the following informalities:
Claim 13 - “huma” (line 2) should read “human”
Claim 30 - “human subject” is also referenced as “human patient.” Applicant is advised to maintain naming conventions throughout the application.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 39-40 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.
Regarding claim 39, dependent on claims 1 and 37, the instant claim recites the limitations "the checkpoint inhibitor" and “the chemotherapy” in line 2. There is insufficient antecedent basis for these limitation in the claim based on current claim dependency. For examination purposes, the claim has been interpreted based on the method of claim 1 only (e.g. anti-GAL9 antibody).
Regarding claim 40, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. While the use of the term “optionally” is not pro se indefinite, as used in the instant claims the term reads as exemplary claim language and introduces ambiguity to the claims as the intended scope of the claims becomes unclear. See MPEP § 2173.05(d) and MPEP § 2173.05(h)(II).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 42, 43, 45, and 48 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106(III):
Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Yes. The claims are drawn to processes (methods)
Step (2A) Prong 1: Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea (i.e. judicial exception)?
Yes. The claims are directed to abstract ideas of “identifying an ocular melanoma patient…” (claim 42), “determining tumor burden or metastatic status in a patient having ocular melanoma…” (claim 43), “assessing progression of ocular melanoma in a subject…” (claim 45), and “determining a response to a treatment in a subject having ocular melanoma…” (claim 48). In broadest reasonable interpretation of the claims, “identifying,” “determining,” and “assessing” recite mental process of comparison between groups (i.e. relative to reference).
Step (2A) Prong 2: If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
No. The instant claims do not recite additional elements that integrate the judicial exception into a practical application because “optionally treating” or “optionally modifying” do not affirmatively recite requiring a treatment to occur (i.e. there is an option to not administer a treatment rendering the method diagnostic only). Moreover, the “treatment” as recited does not provide meaningful constraints on the treatment step (i.e. manner or type of treatment), which is at most an instruction to “apply” the judicial exception.
Step (2B): If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly more than the judicial exception?
No. The instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because “measuring the levels of GAL9” from patient samples is ‘mere data gathering’ and therefore considered insignificant extra-solution activity (See MPEP 2106.05(g)). Furthermore, diagnostic molecular signatures of patient samples using a naturally occurring correlation inherent to most cancers (i.e. upregulation of immune resistance mechanism) are well-understood, routine, and conventional in the art (Pardoll. Nat Rev Cancer. 2012;12(4):252-264; Figure 1).
As the instant claims recite judicial exceptions without integrating into practical application, and further limitations do not provide significantly more, the claims were found not be drawn to an inventive concept eligible under 35 USC 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-7, 9-17, 23-25, 30, 40-43, 45, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over US 10,450,374 B2 (herein Koide) and Wierenga (Invest Ophthalmol Vis Sci. 2019;60(14):4740-4747).
Regarding claims 1, 9-10, 30, 32, 40, and 41, Koide teaches a method for treating a solid tumor that expresses galectin-9 (GAL9) (i.e. GAL9 levels examined and confirmed in tumor tissue), an immune checkpoint molecule based on its role as ligand for T-cell immunoglobulin mucin-3 (TIM-3) (column 1, lines 25-41), in a subject by administering an effective amount of a pharmaceutical composition comprising an identical GAL-9 antibody (clone G9.2-17) (Koide SEQ ID NOs: 361, 388, 406, 328, 329, and 352 are identical to instant SEQ ID NOs: 4, 5, 6, 1, 2, and 3, respectively; alignment below) (claim 11) and teaches the solid tumor can be melanoma (claim 17) which is disclosed as aggressive and frequently characterized by metastasis and resistance to therapies (column 1, lines 55-60; column 144-145 spanning ¶). Moreover Koide teaches patients with metastatic melanoma with high blood levels of GAL9 are correlated with worse overall survival (column 144, lines 22-25).
Instant CDR fusion aligned with Koide CDR fusion (‘xxxx’ separated):
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While Koide explicitly discloses melanoma and teaches that the cancer in some embodiments can be eye cancer (column 140, line 55), Koide doesn’t explicitly disclose ocular/uveal melanoma.
Wierenga teaches GAL9 is a clinical predictor in uveal melanoma (UM) and teaches high levels of GAL9 (i.e. relative to cancer free status) measured from patient samples derived from anterior chamber aqueous humor correlates to worse survival (pg. 4746, left column, ¶ 6) Wierenga acknowledges that in certain cohorts lower expression of GAL9 in patient UM tumor samples was conversely associated with worse survival rates (i.e. positive prognostic marker), but hypothesize GAL9 levels in the anterior chamber fluid (i.e. produced by the ciliary body) are more indicative of an overall higher proinflammatory environment resulting from a prognostically bad UM. Wierenga teaches UM with involvement of the ciliary body are more aggressive tumors, leading to more leakage of inflammatory mediators (e.g. GAL9) (pg. 4746, right column, ¶ 3).
A skilled artisan would recognize that because GAL9 is also upregulated in species of ocular melanoma (e.g. uveal with ciliary body pathology) as taught by Wierenga it may serve as a therapeutic target. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of to modify a known method of treating genus melanoma using an anti-GAL9 with CDRs identical to the instant claims as taught by Koide to treat specific species UM with a reasonable expectation of success as Wierenga teaches increased GAL9 in the UM tumor microenvironment (TME) is indicative of a prognostically worse UM, thereby arriving at the instantly claimed invention.
Regarding claims 4-7, the combined teachings of Koide and Wierenga teach claim 1 as discussed above. Koide further teaches the anti-GAL9 antibody is an IgG1 or IgG4 (claim 14), and teaches identical VH/VL (claim 15; SEQ ID NOs: 55 and 54 are identical to instant SEQ ID NOs: 7 and 8, respectively), heavy and light chain constant regions (claim 16; SEQ ID NOs: 422 and 418 are identical to instant SEQ ID NOs: 14 and 11, respectively), and heavy and light chain sequences (SEQ ID NOs: 316 and 108 are identical instant SEQ ID NOs: 19 and 15, respectively; annotated alignments shown below).
Instant SEQ ID NO:19 aligned with Koide SEQ ID NO:316:
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617
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Instant SEQ ID NO:15 aligned with Koide SEQ ID NO:108:
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420
617
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Regarding claims 11-15, the combined teachings of Koide and Wierenga teach claim 1 as discussed above. Koide further teaches administration of disclosed antibodies (e.g. G9.2-17) with an initial dose of 2mg/kg and teaches a typical daily dosage might range from about 0.1 μg/kg to 100mg/kg or more depending on various factors (column 157, lines 3-10). Koide further teaches an exemplary dosing regimen comprising administering an initial dose of about 2mg/kg, followed by a weekly maintenance dose of about 1mg/kg of the antibody, or followed by a maintenance dose of about 1 mg/kg every other week (column 157, lines 15-19).
Regarding claim 16, the combined teachings of Koide and Wierenga teach claim 1 as discussed above. Koide further teaches administration of anti-GAL9 antibodies can be “administered by intravenous administration, e.g., as a bolus or by continuous infusion over a period of time…” (column 154, lines 10-16).
Regarding claims 17 and 23-25, the combined teachings of Koide and Wierenga teach claim 1 as discussed above. Koide further teaches an “effective amount” refers to amount of each active agent required to confer therapeutic effect on the subject, either alone or in combination with one or more active agents (column 156, lines 23-26). Moreover, Koide teaches compositions of the disclosure can comprise either the anti-GAL9 antibody alone or in combination with other therapeutic agents (e.g. chemotherapy or immunotherapy) (column 151, lines 17-24). Koide teaches co-use of an anti-GAL9 antibody and an chemotherapeutic agent (e.g. gemcitabine) or immunotherapeutic agent would be expected to result in significantly enhanced therapeutic activity against solid tumors (column 170, last ¶; column 174, ¶ 3), and teaches non-limiting examples including gemcitabine (antimetabolite as defined in the instant disclosure; pg. 4, line 14) (column 171, line 19) and microtubule disruptor paclitaxel (column 171, line 25).
Regarding claim 18, the combined teachings of Koide and Wierenga teach claim 1 as discussed above. Koide further teaches the method can further comprise administration of an effective amount of a checkpoint inhibitor (claim 19), wherein the inhibitor can be an anti-PD-1 antibody (claim 20) and teaches specific anti-PD-1 antibody pembrolizumab (column 180, line 50).
Regarding claim 40, the combined teachings of Koide and Wierenga teach claim 1 as discussed above. Koide further teaches that before, during, and after administration of the pharmaceutical composition, cancerous cells and/or biomarkers in a subject may be measured in a biological sample, such as blood, serum, plasma, urine, peritoneal fluid, and/or a biopsy from a tissue or organ.
Regarding claims 42-43, 45, and 48, Koide teaches an anti-GAL9 antibody as disclosed can be used in diagnostic/prognostic methods such as “for the detection of cells expressing Galectin-9 in an assessment of treatment eligibility and/or efficacy” (column 25, lines 2-6). Koide teaches patients with metastatic melanoma expresses high blood levels GAL9 (column 144, lines 22-25).
Koide does not disclose specific ocular melanoma.
Wierenga teaches samples (aqueous humor) from patients with aggressive uveal melanoma (UM; i.e. ocular melanoma) express high levels of GAL9.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention that the diagnostic/prognostic methods as disclosed by Koide can be modified for ocular melanoma with a reasonable expectation of success because Wierenga teaches UM severity is also correlated with GAL9 levels.
Claims 18 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Koide and Wierenga as applied to claim 11 above, and further in view of Ai (Drug Des Devel Ther. 2020;14:3625-3649) and Bristol-Myers Squibb (OPDIVO® (nivolumab) prescribing information, 2016).
The combined teaching of Koide and Wierenga teach claim 1 as discussed above.
None of these references teach a total mg dosage for PD-1 antibodies nivolumab nor tislelizumab administration.
Ai teaches that, at the time of filing, there were six immune checkpoint inhibitors targeting PD-1/PD-L1 pathway that are FDA approved (i.e. safe for clinical use); three targeting PD-1 (pembrolizumab, nivolumab and cemiplimab) and three targeting PD-L1 (atezolizumab, avelumab and durvalumab) (pg. 3627, left column, ¶ 1). Ai further teaches both pembrolizumab and nivolumab are approved for the treatment of melanoma (pg. 3643, left column).
Bristol-Myers Squibb teaches dosage and administration of nivolumab for unresectable or metastatic melanoma via intravenous infusion of 240mg every 2 weeks (pg. 1, left column, ‘Dosage and Administration’; pg. 39-46, section 14.1)
It would have been obvious to one of ordinary skill in the art prior that substituting a known FDA-approved antibody pembrolizumab as disclosed in GAL9 combination therapy by Koide for an alternative FDA approved antibody nivolumab as taught by Ai would have a reasonable expectation of success because Ai teaches both have been deemed effective in treating melanoma. Furthermore, it would have been obvious to try a nivolumab dose according to manufacturer recommendations (i.e. as taught by Bristol-Myers Squibb) because this dosage has already been verified as effective in melanoma.
Claims 26, 27 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Koide and Wierenga as applied to claim 25 above, and further in view of Davis (Invest New Drugs. 2020;38(3):821-830).
The combined teaching of Koide and Wierenga teach claim 1 and 25 as discussed above.
However neither reference teach standard dosage for gemcitabine and/or paclitaxel chemotherapeutics nor dosing schedule.
Davis teaches a method for treating pancreatic ductal adenocarcinoma (PDA) with a monoclonal antibody targeting a pathway known to contribute to PDA development and maintenance in combination with nanoparticle albumin-bound (nab)-paclitaxel (i.e. protein bound paclitaxel) and gemcitabine (abstract; pg. 822, left column, ¶ 3-4). Davis teaches a method wherein patients were treated by intravenous infusion in 28-day cycles, wherein the antibody was administered on days 1 and 15, and nab-paclitaxel and gemcitabine were then administered at standard doses of 125 mg/m2 and 1000 mg/m2, respectively, on days 1, 8, and 15 of each 28-day cycle (Figure 1; pg. 822, right column, ¶ 3-4), wherein no dose-limiting toxicity (DLT) was observed (pg. 824, right column, ¶ 2).
One of ordinary skill in the art would recognize that cancer treatments can be modified based on respective biomarkers and/or likely therapeutic targets. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention that a use of a known cotreatment dosing schedule as taught by Davis can be applied to a known method of treating UM with an anti-GAL9 antibody and chemotherapy as taught by the combined teachings of Koide and Wierenga with a reasonable expectation of therapeutic benefit as Davis teaches this dosing schedule has minimal DLT and Koide teaches combining an anti-GAL9 antibody with a chemotherapeutic agent would be expected to result in significantly enhanced therapeutic activity against solid tumors.
Claims 37 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Koide and Wierenga as applied to claims 1 above, and further in view of Brahmer (J Clin Oncol. 2018;36(17):1714-1768).
The combined teaching of Koide and Wierenga teach claim 1 as discussed above.
However neither reference teach specific adverse effect monitoring and maintenance.
Brahmer teaches early recognition and proper management of immunotherapy-related adverse events (irAEs) is imperative to improving patient outcomes with immune checkpoint inhibitor (ICI) therapies (Introduction). Brahmer teaches irAEs are commonly seen in the skin; GI tract; lungs; and endocrine, thyroid, adrenal, pituitary, musculoskeletal, renal, nervous, hematologic, cardiovascular, and ocular systems, and there should be a high level of suspicion that any changes are treatment-related (pg. 1716, left column, ¶ 3). While Brahmer teaches dose adjustments are not recommended, immunotherapies that result in irAEs can be withheld until laboratory values revert, upon which the patient can be rechallenged (i.e. reducing the dose frequency) (pg.1715, bullet 6) this falls within scope of the “Dose Reduction” strategies as outlined in the instant specification (Instant specification; Tables 27 and 28).
One of ordinary skill would recognize that recommendations for similar immune checkpoint inhibitor therapies would reasonably apply to others within the same category. Therefore, it would be obvious to combine known methods of ICI therapy targeting GAL9 as taught by the combined teachings of Koide and Wierenga with known monitoring methods and treatment recommendations in response to irAEs as taught by Brahmer to ensure positive patient clinical outcomes.
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.
US 10,450,374 B2
Claims 1, 4-7, 9, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-17 and 19-20 of U.S. Patent No. 10,450,374 B2 (herein US374) in view of Wierenga (cited above).
Claim 11 of US374 claims a method for treating a solid tumor that expresses galectin-9 (GAL9) in a subject by administering an effective amount of a pharmaceutical composition comprising an identical GAL-9 antibody (clone G9.2-17) (Koide SEQ ID NOs: 361, 388, 406, 328, 329, and 352 are identical to instant SEQ ID NOs: 4, 5, 6, 1, 2, and 3, respectively; alignment below). Claim 12 of US374 (dependent on claim 11) further claims the antibody is a full-length antibody (defined to include IgG molecules according the instant specification; pg. 3, line 13); claim 13 of US374 claims the antibody is an scFv or an IgG molecule; and claim 14 of US374 (dependent on claim 13) claims the antibody is an IgG1 or an IgG4. Claim 15 of US374 (dependent on claim 11) claims identical VH/VL sequences (SEQ ID NOs: 55 and 54 are identical to instant SEQ ID NOs: 7 and 8, respectively) and claim 16 of US374 claims identical HC/LC constant regions (SEQ ID NOs: 422 and 418 are identical to instant SEQ ID NOs: 14 and 11, respectively), which when fused to claimed VH/VL sequences are identical to instantly claimed HC/LC sequences (instant SEQ ID NOs: 19 and 15). Claim 17 of US374 further claims the solid tumor is melanoma. Claims 19 and 20 of US374 (dependent on claim 11) claim the method further comprises an ICI, wherein the ICI is an anti-PD-1 antibody (disclosed in the specification to include pembrolizumab; column 180, line 50)
US374 does explicitly claim ocular melanoma.
Wierenga teaches GAL9 is expressed in uveal melanoma (UM; i.e. ocular melanoma).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention that a tumor that expresses GAL9 would be within scope of a solid tumor that expresses GAL9 (e.g. UM), and therefore the claims are patentably indistinct.
US 17/598,215
Claims 1, 4-7, 9, 18, and 23-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 37-38, 42-48, and 50-52 of copending Application No. 17/598,215 (herein US215) in view of Wierenga (cited above).
Claim 37 of US215 claims a method of modulating immune response in a solid tumor (defined in the instant specification to include ocular melanoma; pg. lines 28-29) of a subject comprising administering an anti-GAL9 antibody with identical CDRs to the instant claims (SEQ ID NOs: 22, 23, 24, 19, 20, and 21 are identical to instant SEQ ID NOs: 4, 5, 6, 1, 2, and 3, respectively). US215 defines “modulating” to include “increasing” an immune response (i.e. an increase in overall inflammatory immune response as determined by a reduction in tumor weight, size or burden; pg. 53, lines 20-22), thus by broadest reasonable interpretation a skilled artisan would recognize the claimed immune modulation would be analogous to treatment of said tumor. Claim 38 of US215 claims the solid tumor is selected from a group that includes melanoma. Claim 42 of US215 (dependent on claim 37) claims the antibody is full-length (defined to include IgG molecules according the instant specification; pg. 3, line 13). Claim 43 of US215 (dependent on claim 37) claims the antibody is an IgG1 or an IgG4, optionally with S228P mutation (present in instant SEQ ID NO:35). Claim 44 of US215 (dependent on claim 42) claims an antibody with identical VH/VL sequences (SEQ ID NOs: 10 and 9 are identical to instant SEQ ID NOs: 7 and 8, respectively). Claim 45 of US215 (dependent on claim 44) claims the antibody is an IgG1 or an IgG4, optionally with S228P mutation (present in instant SEQ ID NO:35). Claim 46 of US215 (dependent on claim 37) claims identical HC/LC constant regions (SEQ ID NOs: 35 and 37 are identical to instant SEQ ID NOs: 14 and 11, respectively). Claim 47 of US215 (dependent on claim 44) claims the same identical VH/VL and HC/LC constant region sequences (disclosed above). Claim 48 of US215 (dependent on claim 44) claims identical HC/LC sequences (SEQ ID NOs: 41 and 47 are identical to instant SEQ ID NOs: 19 and 15, respectively). Claim 50 of US215 (dependent on claim 38) further claims administration of an effective amount of a checkpoint inhibitor and/or chemotherapeutic agent. Claim 51 of US215 (dependent on claim 50) claims the checkpoint inhibitor is an anti-PD-1 antibody. Claim 52 of US215 (dependent on claim 50) claims the chemotherapeutic agent is gemcitabine and/or paclitaxel.
US215 does not explicitly claim ocular melanoma.
Wierenga teaches GAL9 is a clinical predictor in uveal melanoma (UM; i.e. ocular melanoma) and teaches high levels of GAL9 (i.e. relative to cancer free status) measured from patient samples derived from anterior chamber aqueous humor correlates to worse survival (pg. 4746, left column, ¶ 6).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention that a any solid tumor that is associated with high GAL9 expression (e.g. ocular melanoma as taught by Wierenga) would be within scope of a solid tumor that would benefit from immune modulation, and therefore the claims are patentably indistinct.
This is a provisional nonstatutory double patenting rejection.
US 17/631,378
Claims 1, 4-7, 10-16, 23-27, 29-30, 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8-14, 16-20, 22, 24, and 26-29 of copending Application No. 17/631,378 (herein US378). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of US378 claims a method for treating a solid tumor (defined in the instant specification to include ocular melanoma; pg. lines 28-29) comprising administering an effective amount of an anti-GAL9 antibody with identical CDRs to the instant claims and an effective amount of one or more chemotherapies. As ocular melanoma is considered a solid tumor a skilled artisan would recognize that the claims overlap in scope and therefore are patentably indistinct. Claim 4 of US378 (dependent on claim 1) further claims the solid tumor is a metastatic solid tumor. Claims 8-10 of US378 (dependent on claim 1) further claim overlapping doses of anti-GAL9 administration every two weeks by intravenous injection. Claim 11 of US378 (dependent on claim 1) claims an identical dose schedule for anti-GAL9 antibody, gemcitabine, and paclitaxel administration. Claim 12 of US378 (dependent on claim 11) claims the paclitaxel is protein-bound. Claims 13-14 of US378 (dependent on claim 1) claim identical doses of paclitaxel and gemcitabine. Claim 16 of US378 (dependent on claim 1) claims identical VH/VL sequences. Claim 17 of US378 (dependent on claim 1) claims the anti-GAL9 antibody is an IgG4 molecule. Claim 18 of US378 (dependent on claim 17) claims identical HC/LC sequences. Claim 19 of US378 (dependent on claim 1) claims the subject is human. Claim 20 of US378 (dependent on claim 1) claims subject comprises GAL9 positive cancer cells (i.e. tumor that expresses GAL9). Claim 22 of US378 (dependent on claim 1) claims the subject has an elevated level of GAL9 relative to a control value. Claim 24 of US378 (dependent on claim 1) claims the subject is free of prior therapy. Claim 26 of US378 (dependent on claim 1) claims the subject is examined for one or more feature before, during/or after treatment listing patentably indistinct categories (a)-(c). Claims 27-28 of US378 (dependent on claim 1) claims the method further comprises adverse effects monitoring (claim 27), wherein the adverse effects comprise an overlapping list of toxicities (claim 28). Claim 29 of US378 (dependent on claim 27) further claims reducing treatment doses when adverse effect is observed. Claim 35 of US378 (dependent on claim 1) claims the anti-GAL9 antibody is administered once every week
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
US 18/697,500
Claims 1, 4-7, 10-16, 18, 21-22, 30, 32, 37, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-9, 11, 17-23, 25-26, 28-30 of copending Application No. 18/697,500 (herein US500). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of US500 claims a method for treating solid tumor (defined in the instant specification to include ocular melanoma; pg. lines 28-29) comprising administering an effective amount of anti-GAL9 antibody with identical CDRs and an effective amount of tislelizumab, wherein the anti-GAL9 antibody is administered at dose range and at specific doses (claims 4-5) which overlaps with instantly claimed doses (e.g. instant claims 11-14). Claim 3 of US500 (dependent on claim 1) claims the solid tumor is metastatic. Claims 6-7 of US500 (dependent on claim 1) claims the anti-GAL9 antibody is administered once every week (claim 6) wherein the claimed doses (claim 7) are also within scope of instant claims. Claim 8 of US500 (dependent on claim 1) claims intravenous infusion of anti-GAL9 antibody. Claim 9 of US500 (dependent on claim 1) claims identical doses for tislelizumab administration. Claim 11 of US500 (dependent on claim 9) further claims intravenous infusion of tislelizumab. Claim 17 of US500 (dependent on claim 1) claims the subject is human. Claim 18 of US500 (dependent on claim 1) claims identical VH/VL sequences. Claim 19 of US500 (dependent on claim 18) claims the anti-GAL9 antibody is an IgG1 or IgG4 molecule. Claims 20-21 of US500 (dependent on claim 19) claim a modified IgG4 Fc identical to instantly claimed HC constant region (SEQ ID NO:14). Claim 22 of US500 (dependent on claim 22) claims identical HC/LC sequences. Claims 23 and 25 of US500 (dependent on claim 1) further claims the subject has undergone one or more prior anti-cancer therapies (claim 23), wherein the subject has progressed disease through one or more therapies or is resistant to the one or more therapies (claim 25). Claim 26 of US500 (dependent on claim 1) claims elevated levels of GAL9 relative to control. Claim 28 of US500 (dependent on claim 1) claims cancer cells express GAL9. Claim 29 of US500 (dependent on claim 1) claims adverse effects monitoring. Claim 30 of US500 (dependent on claim 29) further claims reducing dose when adverse effect occurs.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are currently allowed.
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/HANNAH SUNSHINE/Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647