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
The instant application, filed 11/09/2022, is a 371 filing of PCT/EP2021/062307, filed 05/10/2021, which claims domestic priority to provisional U.S. application numbers 63/166,291, filed 03/26/2021, and 63/022,730, filed 05/11/2020.
Amendments and Claim Status
The amendment filed on 10/24/2023 is acknowledged and entered.
Claims 1-24 and 26-28 are cancelled;
Claims 29-50 are added.
Claims 25 and 29-50 are pending.
Information Disclosure Statement
The Information Disclosure Statement filed on 05/03/2023 and 11/05/2025 are acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statements are considered.
Restriction/Election
Applicant’s election of the following species in the reply filed on 11/06/2025 is acknowledged:
Species A: AZD6738
Species B: immune checkpoint inhibitor pembrolizumab
Species C: paclitaxel
Species D: melanoma
In accordance with the MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP § 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected species do not make a contribution over the prior art of record.
Status of Claims
Claims 25 and 29-50 are pending in the instant application. No claims are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected species. Therefore, claims 25 and 29-50 read on an elected invention and species and are therefore under consideration in the instant application.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 12). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Drawings Objection
The drawings filed on 11/09/2022 are objected to under 37 CFR § 1.83(a) for the following reasons:
The different data types are indistinguishable in Figure 4. The figures rely on color-coding of the data, a feature not available in the black and white drawings. More specifically the data named CR, PR, and PD will as well as SD and N/A are similarly shaded and indistinguishable within the figure The figures must be remade with shapes or line-types used to describe the different data points.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR § 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR § 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim interpretation
The instant claims are subject to the following interpretation:
Claim 25 recites “a method of treating cancer to a human or animal patient.” The claim is interpreted according to the broadest reasonable interpretation to be drawn to “a method of treating cancer in a human or animal patient” (see MPEP § 2111).
Claim Rejections – 35 U.S.C. § 112
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 25 and 29-50 are rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. § 112, the applicant), regards as the invention.
Claim 25 recites “treating cancer to a human or animal patient.” It is unclear what “treating cancer to a human or animal patient” means. Thus an ordinary skilled artisan cannot ascertain the metes and bounds of the claimed invention and thus the claims are properly rejected as being indefinite.
Regarding claims 29-50, the claims depend on a claim rejected as being indefinite (claim 25) and fail to remedy the indefiniteness of the claim on which it depends, and is therefore dually rejected as indefinite.
Claim Rejections – 35 U.S.C. § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 25, 29, 31, 32, 36-38, and 44-45 and 49 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by NCT03780608 (“History of Changes for Study: NCT03780608 Phase II Study of AZD6738 in Combination With Durvalumab in Patients With Solid Tumor," ClinicalTrials.gov, Version 1, posted December 19, 2018), hereinafter NCT’608.
The instant claims are drawn to a method of treating cancer, elected to be melanoma, comprising the administration of an ATR inhibitor, elected to be AZD6738, in patients who have previously received immunotherapy.
NCT’608 teaches a clinical treatment regimen in cancer patients, comprising treating melanoma in a human patient comprising the administration of AZD6738 to said patient who has previously received anti-PDL1 therapy immunotherapy (Title, see instant claims 25, 29, and 44-46). The study teaches the administration of AZD6738 twice-daily at 240 mg (Brief Summary, Intervention, see instant claims 31 and 32). The patients included in the study are those diagnosed with gastric cancer, as well as metastatic melanoma that have failed prior with anti-PD(L)1 therapy, i.e., immune checkpoint inhibitor therapy (Cohort B: eligibility criteria, participation criteria, see instant claims 25, 36-38 and 45).
With regard to instant claim 49, wherein the treatment achieves an objective response rate greater than 30%— this is deemed to be an inherent result of practicing the method disclosed by the prior art. The reference teaches the administration of the elected ATR inhibitor to treat melanoma patients previously treated with immune checkpoint inhibitors with the instantly claimed dosages. Thus, the reference is directed to a therapeutic medical trial designed to evaluate antitumor efficacy, including objective response as a standard clinical endpoint the recited “objective response rate” therefore does not impose a further structural or procedural limitation of the claimed method, but merely states the result or property of the treatment taught by NTC’608. Regarding inherent properties, the courts have stated,
In re Reynolds, 443 F.2d 384, 170 USPQ 94 (CCPA 1971); In re Smythe, 480 F. 2d 1376, 178 USPQ 279 (CCPA 1973); Yeda Research and Dev. Co. v. Abbott GMBH & Co., 837 F.3d 1341, 120 USPQ2d 1299 (Fed. Cir. 2016) ("Under the doctrine of inherent disclosure, when a specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as adequate written description to support a subsequent patent application that explicitly recites the invention’s inherent properties." See MPEP § 2163.07 (a).
Therefore, because the method and all the relevant components are disclosed within the prior art, the objective response rate of the method used in a cancer treatment is inherent to the method itself, although not explicitly taught in the reference.
Thus, the reference anticipates the claimed disease context (melanoma), therapeutic agent (AZD6738), daily dosing schedule, and prior immunotherapy regimen as required by the instant claims.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of pre-AIA 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.
Claim 46 is rejected under 35 U.S.C. § 103 as being unpatentable over NCT’608 (see earlier citation) as applied to claims 25, 29, 31, 32, 36-38, and 44-45 and 49 above, and further in view of Chai et al. (Front Pharmacol, Volume 10, published October 23, 2019), hereinafter Chai.
Claim 46 is drawn to a method of treating cancer, elected to be melanoma, in patients who have previously received immunotherapy elected to be pembrolizumab comprising the administration of the ATR inhibitor, elected to be AZD6738.
The teachings of NCT’608 are as set forth above. NCT’608 specifically teaches treating patients who have previously received anti-PDL1 therapy immunotherapy.
However, NCT’608 fails to teach the specific anti-PDL1 therapy, pembrolizumab, as the specific immune checkpoint inhibitor previously administered as the immunotherapy.
The deficiencies of NCT’608 are remedied by Chai, who teaches the safety and tolerability of immune checkpoint inhibitors as treatments for melanoma (Title). Chai identifies pembrolizumab as a PD-1 checkpoint inhibitor which the FDA has approved for melanoma treatment (page 2). Chai further teaches that PD-1/PD-L1 inhibitors PD-1/PD-L1 inhibitors are commonly used in advanced melanoma, and that pembrolizumab had the lowest toxicity among the surveyed immune checkpoint inhibitors (Abstract).
With regard to claim 46, and the use of the elected species pembrolizumab as a failed treatment regimen in melanoma patients, a person of ordinary skill in the art would have understood pembrolizumab to be a representative, standard, and predictable immunotherapy regimen administered to melanoma patients. A person of ordinary skill in the art would have found it obvious to treat melanoma patients who have previously failed pembrolizumab, as this is a common and FDA-approved treatment regimen for melanoma patients, as established by Chai.
Therefore claim 46 of the instant application is rendered obvious.
Claims 30, 33-35, and 50 are rejected under 35 U.S.C. § 103 as being unpatentable over NCT’608 (see earlier citation) as applied to claims 25, 29, 31, 32, 36-38, and 44-45 and 49 above and further in view of NCT02630199 (“Study of AZD6738, DNA Damage Repair/Novel Anti-cancer Agent, in Combination With Paclitaxel, in Refractory Cancer,” ClinicalTrials.gov, posted December 10, 2015, cited in applicant IDS dated 05/03/2023), hereinafter NCT’199.
The teachings of NCT’608 are as set forth above.
The instant claims are further drawn to method of treating cancer in patients who had previously received immunotherapy using an ATR inhibitor, elected to be AZD6738, in combination with a taxane, elected to be paclitaxel.
The disclosure NCT’608 fails to teach a dosing schedule of AZD6738 of 1-14 days (see instant claim 30). Furthermore, the reference fails to teach combining AZD6738 with a taxane, and further fails to disclose the specific elected species, paclitaxel, as a coadministration agent (see instant claims 33-35, and 50).
The deficiencies of NCT’608 are remedied by NCT’199 which teaches a Phase I dose escalation study of AZD6738 in combination with weekly paclitaxel in patients with advanced solid tumors, that have progressed to metastasis (i.e., refractory cancer, Title, see instant claims 33 and 34). The disclosure teaches wherein the starting dose of AZD6738 at 40 mg is escalated to reach a maximum tolerated dose in patients with advanced solid malignancies, as defined by dose-limiting toxicity (Intervention) from baseline until 28 days after discontinuation of study treatment (Outcome Measure, Timeframe). Such a teaching overlaps with the specific range taught in claim 31 and allows for the identification of an optimal dosing schedule, necessary for instant claim 30. Critically, the disclosure identifies a recommended dose of Paclitaxel 80mg/m2 on days 1, 8, and 15 every 4 weeks, i.e. 28 days (see instant claims 33-35).
Accordingly, prior to the effective filing date of the instant claims, it would have been obvious to a person of ordinary skill in the art to combine the teachings of NCT’608 which teaches administering the ATR inhibitor AZD6738 for treating cancer, with the teachings of NCT’199, which teaches AZD6738 can be safely co-administered with paclitaxel for the treatment of advanced and refractory solid tumors. When implementing an ATR inhibitor treatment approach, a person of ordinary skill in the art would have looked to establish clinical studies evaluating AZD6738 in combination with established chemotherapies in order to identify a practical and clinically acceptable coadministration regimen. NCT’199 explicitly discloses the instantly claimed combination therapy and dosing, yielding a reasonable expectation of success.
Regarding claim 30, wherein AZD6738 is administered on days 1 to 14 on a 28 day cycle, this limitation is considered a routine optimization of the parameters provided by the study NCT’199. With regard to the optimization of dosing ranges and schedules, it is noted that the courts have stated,
where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP § 2144.05.01).
The courts have also found that,
“where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 II.
Therefore, the claimed ranges merely represent a routine optimization of the dosage schedule already identified within the cited prior art. The cited prior art provides a framework within which the person of ordinary skill in the art would engage in routine optimization to discover the instantly claimed dosage schedule of both AZD6738 and paclitaxel.
Furthermore, a person of ordinary skill in the art would have had a clear reason to modify NCT’608 following the teachings of NCT’199 to include paclitaxel, as the latter clinical trial provides human clinical dose finding data establishing tolerability, safety, and efficacy for the same inhibitor (AZD6738) in combination with paclitaxel, for the common purpose of treating cancer.
Regarding claim 50, and the administration of the combination of the AZD6738 and paclitaxel, to a patient who has received immunotherapy it is considered prima facie obvious to combine two art-recognized equivalents for a common purpose. With regard to the combination of art recognized equivalents, according to MPEP § 2144.06 (I), the courts have determined,
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) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.).
The disclosure of NCT’199 teaches that both AZD6738 and paclitaxel may be used in the treatment of cancer. As such, their combination is further rendered obvious. With respect to the administration of paclitaxel to a patient who has previously received immunotherapy, a person of ordinary skill in the art would have been motivated to modify the melanoma treatment regimen of NCT’608 (the treatment of a melanoma patient who has previously failed IO), to further include paclitaxel as taught by NCT’199, because the latter disclosure provides human clinical evidence that AZD6739 can be safely and effectively combined with paclitaxel, demonstrating therapeutic benefits in cancer patients. Such a modification represents a predictable combination of known therapeutic agents applied to the same disease context to address a well-recognized clinical problem in the art of cancer treatment (limited response after immunotherapy), with a reasonable expectation of success.
Claims 47 and 48 are rejected under 35 U.S.C. § 103 as being unpatentable over(see earlier citation), as applied to claims 25, 29, 31, 32, 36-38, and 44-45 and 49 above, and further in view of Sharma et al. (Cell, Volume 168, Issue 4, pages 707-723, published February 9, 2017), hereinafter Sharma.
The teachings of NCT’608 are as set forth above.
The instant claims are further drawn to method of treating cancer in patients who had previously received immunotherapy using an ATR inhibitor, elected to be AZD6738, in patients with primary resistance or acquired resistance to immunotherapy.
The disclosure NCT’608 fails to teach wherein failure of immunotherapy is a specific differentiated resistance category such as primary resistance or acquired resistance (see instant claims 47 and 48). Rather, the disclosure of NCT’608 treats immunotherapy treated patients as a generalized population of immunotherapy failure without mechanistic differentiation underlying the specific resistance phenotype.
The deficiencies of NCT’608 are remedied by Sharma, who provides comprehensive framework defining mere resistance, adaptive resistance, and acquired resistance cancer immunotherapy, explicitly distinguishing patients who never respond to the checkpoint inhibitors from those who relapsed after an initial response (Table 1). Sharma further teaches that resistance mechanisms are driven by tumor intrinsic defects and tumor extrinsic immunosuppression (page 708). Sharma further discloses that rational combination therapies are required to overcome both primary and acquired resistance (page 709, Table 3). Most importantly, Sharma teaches that targeting complementary pathways involved in genomic instability and immune evasion is a well-recognized strategy to restore or enhance immunotherapy efficacy in resistant patients (pages 709, 712, and 716).
A person having ordinary skill in the art, prior to the effective filing date of the instant claims, would have been motivated to apply Sharma’s teachings to melanoma treatment patients who have failed immunotherapy as disclosed in NCT’068, in order to address a well-recognized clinical problem: that a substantial portion of patients face failures in immunotherapy. Sharma explicitly teaches that understanding resistance phenotypes enables rational selection of combination therapies designed to overcome immune escape mechanisms (page 709). Thus, a person having ordinary skill in the art would have recognized that combining ATR inhibition with immunotherapy, as taught by NCT’068, would particularly be beneficial in patients with primary or acquired resistance, as indicated by Sharma in the targeting of complementary pathways (pages 709, 712, and 716). As such, a person of ordinary skill in the art would contemplate applying the treatment regimen of NCT’608 to patients affected by such common forms of immunotherapy resistance. This modification simply represents a predictable use of prior art elements according to established principles in the art, with a reasonable expectation of success.
Claims 39-41 are rejected under 35 U.S.C. § 103 as being unpatentable over NCT’608 (see earlier citation) as applied 25, 29, 31, 32, 36-38, and 44-45 and 49 above, and further in view of Kuk et al. (The Oncologist, Volume 21, Issue 7, pages 848–854, Published June 10, 2016), hereinafter Kuk.
The teachings of NCT’608 are as set forth above.
The instant claims are drawn to a method of treating cancer, elected to be melanoma, in patients who have previously received immunotherapy, wherein the melanoma is cutaneous, acral, or mucosal melanoma.
The disclosure NCT’608 fails to teach wherein the melanoma treated is a specific subtype, such as cutaneous melanoma (see instant claim 39), acral melanoma (see instant claim 40), or mucosal melanoma (see instant claim 41).
The deficiencies of NCT’608 are remedied by Kuk who teaches that melanoma is a heterogeneous disease composed of distinct, well-recognized subtypes, including (non-acral) cutaneous melanoma, acral cutaneous melanoma, and mucosal melanoma (Title). Kuk discloses a large retrospective analysis (n = 3,454) comparing treatment outcomes across these melanoma subtypes (Abstract). The disclosure demonstrates that cutaneous, acral, and mucosal melanomas are well-recognized subtypes, i.e. species of the genus melanoma (Table 3).
Accordingly, a person having ordinary skill in the art, prior to the effective filing date of the instant claims, would have been motivated to modify the melanoma treatment disclosure of NCT’068 to expressly encompass cutaneous, acral, and mucosal melanomas, because as taught by Kuk, melanoma is a clinically heterogeneous disease that is routinely classified into said subtypes. A person having ordinary skill in the art would have understood that therapeutic studies and treatment protocols referring generally to “melanoma” inherently contemplate application to the standard subcategories. As such, the ordinarily skilled artisan would have reasonably expected that the disclosed ATR-inhibitor treatment disclosed by NCT’068 would be applicable across such melanoma subtypes without undue experimentation. Taken together, the prior art demonstrates that the cited claims are drawn to a well-recognized disease categorization, rather than an inventive selection of specific species of melanoma to treat. As such, the claims are rendered obvious.
Claims 42 and 43 are rejected under 35 U.S.C. § 103 as being unpatentable over NCT’608, as applied to claims 25, 29, 31, 32, 36-38, and 44-45 and 49 above, and further in view of Ticha et al. (Scientific Reports, Volume 9, Article number: 17050, Published 19, 2019), hereinafter Ticha, and Minchom et al. (Ther Adv Med Onc, Volume 10, published July 13, 2018), hereinafter Minchom.
The teachings of NCT’608 are as set forth above.
The instant claims are drawn to a method of treating cancer elected to be melanoma. in patients who have previously received immunotherapy, wherein the melanoma is ATM or ARID1A deficient.
The disclosure NCT’608 fails to teach wherein the cancer treated is either ATM- or ARID1A-deficient (see instant claims 42 and 43).
The deficiencies of NCT’608 are remedied by Ticha, who teaches wherein cutaneous melanoma is characterized by recurrent genetic alterations across multiple functional pathways, including genes involved in DNA damage response (DDR), and chromatin remodeling (Abstract). Ticha identifies ATM as a gene frequently altered within melanoma associated DNA damage response pathways, and further identifies ARID1A as a chromatin remodeling gene affected by mutations melanoma (pages 2 and 3, Tables 2 and 3). The genomic analysis disclosed by Ticha establishes that alterations in ATM and ARID1A occur in melanoma tumors, and contribute to tumor biology, thereby identifying ATM-deficient and ARID1A-deficient melanoma as clinically relevant molecular subtypes of the disease.
Although Ticha identifies the presence of ATM and ARID1A alterations melanoma, Ticha fails to teach a specific therapeutic strategy targeting these deficiencies for the treatment. Furthermore, Ticha fails to teach the treatment of ARID1A and ATM deficient melanoma with an ATR inhibitor.
The deficiencies of NCT’608 and Ticha are remedied by Minchom who teaches that defects in the DDR pathway—specifically ATM and ARID1A deficiencies—create a state of heightened replication stress and impaired DNA repair (Abstract, page 1). As a result, DDR renders tumor cells particularly dependent on pathways such as that of ATR signaling for survival (pages 3 and 6). Minchom teaches that ATR inhibitors, and specifically AZD6738 are effective in treating ATM-deficient cancers (page 6). The disclosure further teaches that ATM-deficient tumors are unable to properly respond to DNA double strand breaks, and consequently rely on ATR-mediated checkpoint control to stabilize stalled replication forks (page 6). When ATR is inhibited, these replication forks collapse, and tumor cells die (pages 1 and 6). Minchom further discloses that loss of ARID1A disrupts normal DNA replication and repair processes, increasing replication associated DNA damage, and sensitize tumors to ATR inhibition due to an inability to tolerate additional checkpoint disruption (page 9). Taken together, these teachings establish a clear rationale for ATR inhibition in these molecularly-defined cancer phenotypes.
A person of ordinary skill in the art, prior to the effective filing date of the instant claims, would have been motivated to apply the ATR inhibitor treatment regimen taught by NCT’608 to treat melanoma patients whose tumors are ATM and ARID1A deficient following the teachings of Ticha and Minchom. Ticha teaches that cutaneous melanoma commonly includes mutations or alterations in genes such as ATM and ARID1A leading to DDR-deficiencies, thereby identifying a relevant melanoma patient population. Minchom teaches that ATR inhibitors are effective in DDR-defective settings, including ATM and ARID1A deficient tumors, and that ATM and ARID1A deficiencies are predictive of sensitivity to ATR inhibition in cancer. The selection of patients whose cancer harbors these deficiencies for treatment with an ATR inhibitor is a biologically rational strategy, which provides a reasonable expectation of success in melanoma treatment. Accordingly, a person of ordinary skill in the art would have reasonably expected success in applying the ATR inhibitor treatment of NCT’608 to ATM or ARID1A deficient melanoma.
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 25, 29-32, 36-38, and 44-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2, and 4-28 of copending Application No. 18/552,300, (US 20240197748 A1) Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap in scope in terms of the method and components taught.
Regarding instant claim 25, co-pending claims 2 and 18 teach a method of treating the elected species, melanoma in a patient who has previously received immunotherapy by administering an ATR inhibitor in an immune checkpoint inhibitor context.
Regarding instant claim 29, co-pending claims 4 and 5 teach administration of an ATR inhibitor and specifically, the elected species, AZD6738.
Regarding instant claim 30, co-pending claims 12 and 13 teach administration of AZD6738 on subsets of days within a 28 day cycle, representing routine schedule variations, rendering the instantly claim obvious by way of routine optimization.
Regarding instant claim 31, co-pending claim 14 teaches a daily dose of AZD6738 between 30 and 500mg.
Regarding instant claim 32, co-pending claim 15 teaches administration of AZD6738 twice-daily in 240 mg doses.
Regarding instant claim 36, co-pending claims 2, 10, and 11 teach treatment of melanoma, including advanced and metastatic melanoma.
Regarding instant claim 37, co-pending claims 2 and 11 teach treatment of melanoma, including metastatic melanoma.
Regarding instant claim 38, co-pending claim 2 teaches a method of treating melanoma.
Regarding instant claim 44, co-pending claim 18 teaches that the prior immunotherapy comprises treatment with an immune checkpoint inhibitor.
Regarding instant claim 45, co-pending claim 6 teaches immune checkpoint inhibitors selected from PD-1, PD-L1, and CTLA-4 inhibitors, which are the genus that encompass the instantly claimed species of immune checkpoint inhibitors.
Regarding instant claim 46, co-pending claims 20 and 21 teach the same immune checkpoint inhibitor species, including the elected species pembrolizumab.
Regarding instant claim 47, co-pending claim 22 teaches treatment of patients with primary resistance to immunotherapy.
Regarding instant claim 48, co-pending claim 23 teaches treatment of patients with acquired resistance to immunotherapy.
Regarding instant claim 49, co-pending claims 25-28 teach achieving defined clinical outcomes, including objective response rate, progression free survival, overall survival, and duration of response.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. If a notice of allowance is issued in the co-pending application 18/552,300 upon issue of the patent, the provisionary NSDP rejection over the co-pending application will convert to a NSDP rejection over the published patent.
Correspondence
No claim is allowed.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623