DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of a species of formula (I) with compound 21c, a species of prostate cancer with AR-V7 expressing prostate cancer, and a species of androgen receptor with darolutamide in the reply filed on 08/14/2025 are acknowledged.
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Applicants provided a compliant election of compound 21c as a species of formula (I). A search for Applicants’ elected species 21c retrieved applicable prior art. See “SEARCH 6” in enclosed search notes. Therefore, the search for other species of compounds of formula (I) will not be extended in/for/during this Office Action in accordance with Markush search practice.
Elected compound 21c reads on claims 1-4, 9-10, and 12-24. Applicants believe that the elected species read on claims read on claim 6-8, but the species does not read on these claims because the species has hydrogen substitution at positions 3 and 5 of the pyrazole. Hydrogen substitution is not an allowed group for substitution at these positions for claims 6-8. Due to prior art against the elected species, a search of formula I is limited to this species for prior art and double patenting. Consequently, claims 1-4, 9, 10, and 12-24 are examined on the merits.
Claims 5-8 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/14/2025.
The election of species requirements for a species of prostate cancer and a species of androgen receptor are withdrawn. The Examiner believes that this will facilitate compact prosecution.
Priority
The instant application is a continuation of PCT/US2021/025468, filed April 1, 2021, and claims priority to U.S. Provisional Application No. 63/004474, filed April 2, 2020. The instant claims find support in 63/004474 and are given the effective filing date of April 2, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/07/2022, 02/09/2023, and 03/11/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to because the structure of ARCC4 on figure 9 is small and grainy. The current figure is difficult to interpret because many of the bonds appear to be dashed lines
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. 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.
Specification
The disclosure is objected to because of the following informalities: the figures of the claims compounds of [0060], [0062]-[0064], Table 1 [0194], Table A [0348], and [0377] are grainy and difficult to read. This objection can be rendered moot by replacing the current figures with clear, legible structures that clearly depict the compounds.
Claim Objections
Claims 9 and 10 are objected to because of the following informalities: The chemical compounds depicted in these claims are grainy and difficult to read. Additionally, in claim 10 the word “and” appears after 16i and 26f, while the word “or” appears after 21a. This objection can be rendered moot by replacing the current figures with clear, legible figures that clearly depict the claimed chemical compounds and the removal of the words “and” and “or” from claim 10.
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.
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.
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.
Claims 1-4 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Narayanan (WO 2017214634, found in IDS submitted 12/07/2022).
Determining the scope of the prior art:
Narayanan discloses compound 1048
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(page 22, paragraph [0031]) as a species of selective androgen receptor degrader (SARD) of formula (I).Compound 1048 appears anticipatory against claim 1 because substituents Z and Y replace a H substituent on two ring C-atoms and variables X, B, and D are each CH. The reference teaches compounds of Formula IIA (pg. 14, [0027]) shown below.
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Formula IIA recites the meta-relationship of the carboxamide group to the pyridine N-ring atom (position X). Compound 1048 and elected compound 21c have the same substitutions of variables Z, Y, R1, T, and A, only differing in X.
The reference teaches the use of these compounds for the treatment of prostate cancer, advanced prostate cancer, and castration resistant prostate cancer [001]. The reference teaches that the method of treatment of prostate cancer comprises administering to the subject a therapeutically effective amount of a compound of formula (I) (Claim 16).
Ascertaining the differences between the prior art and the claims at issue:
Narayanan’s 1048 differs from the elected species 21c due to the presence of a nitrogen atom in the western ring.
Resolving the level of ordinary skill in the pertinent art:
Those of relevant skill in the art are those with the level of skill of the inventors of the references cited to support the Examiner’s positions.
Considering objective evidence present in the application indicating obviousness or nonobviousness:
The artisan would have been motivated to employ Narayanan’s 1048 in a method of treating prostate cancer and, given the routine nature of bioisosteric substitution of -CH= for -N= in aryl rings and Narayanan’s teaching that X can be either -CH= or -N=, would have been further motivated to prepare and use the corresponding pyridyl analog. Applicant’s 21c differs from 1048 only by the single heteroatom substitution in the aryl ring. Because this is a conventional, predictable modification the artisan would expect the compound to retain its pharmacological profile. Understanding this, the artisan would reasonably expect that the pyridine analog would exhibit similar AR degrader activity and anticancer utility.
Claims 1, 12-14, 16-20, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Narayanan.
Determining the scope of the prior art:
The teachings of Narayanan are discussed above and teach the limitations of claim 1. The above discussion is incorporated in its entirety into this rejection. In addition to these teachings, Narayanan also teaches the following:
A method of treating prostate cancer (PCa) or increasing the survival of a male subject suffering from prostate cancer comprising administering to the subject a therapeutically effective amount of a compound according to any one of claims 1-11, or its isomer, pharmaceutically acceptable salt, pharmaceutical product, hydrate or any combination thereof. (Claim 16) These teachings read on instant claims 1 and 12.
The method according to claim 16, wherein the prostate cancer is at least one of advanced prostate cancer, refractory prostate cancer, castration resistant prostate cancer (CRPC), metastatic CRPC (mCRPC), non-metastatic CRPC (nmCRPC), or high-risk nmCRPC. (Claim 17) These teachings read on instant claim 12.
The prostate cancer may be advanced prostate cancer, refractory prostate cancer, castration resistant prostate cancer (CRPC), metastatic CRPC (mCRPC), non-metastatic CRPC (nmCRPC), high-risk nmCRPC or any combination thereof. [00170] These teachings read on instant claim 12
The prostate cancer may depend on AR-FL and/or AR-SV for proliferation. The prostate or other cancer may be resistant to treatment with an androgen receptor antagonist. The prostate or other cancer may be resistant to treatment with enzalutamide, bicalutamide, abiraterone, ARN-509, ODM-201, EPI-001, EPI-506, AZD-3514, galeterone, ASC-J9, flutamide, hydroxyflutamide, nilutamide, cyproterone acetate, ketoconazole, spironolactone, or any combination thereof. The method may also reduce the levels of AR, AR-FL, AR-FL with antiandrogen resistance-conferring AR-LBD mutations, AR-SV, gene-amplified AR, or any combination thereof. [00171] These teachings read on instant claim 18
Examples of AR-splice variants include, but are not limited to, AR-V7 and ARv567es. Nonlimiting examples of AR mutations conferring antiandrogen resistance are: W741L, T877A, and F876L mutations. [0080] The SARD compounds may be used in treating CRPC that cannot be treated with any other antagonist. The SARD compounds may treat CRPC by degrading AR-SVs. The SARD compounds may maintain their antagonistic activity in AR mutants that normally convert AR antagonists to agonists. For instance, the SARD compounds maintain their antagonistic activity to AR mutants W741L, T877A, and F876L. [0082] These teachings read on instant claims 13 and 14
The invention encompasses a method of treating prostate cancer (PCa) or increasing survival in a male subject in need of treatment comprising administering to the subject a therapeutically effective amount of a compound defined by formulas I -VII, IA-ID, IIA, IIB, VIIA, or VIIB or any of compounds 1001-1049. The prostate cancer includes, but is not limited to, advanced prostate cancer, castration resistant prostate cancer (CRPC), metastatic CRPC (mCRPC), non-metastatic CRPC (nmCRPC), high-risk nmCRPC or any combination thereof. Another embodiment of the invention encompasses the method further comprising administering androgen deprivation therapy. Alternatively, the method may treat a prostate or other cancer that is resistant to treatment with known androgen receptor antagonist(s) or ADT. In another embodiment, the method may treat enzalutamide resistant prostate cancer. In another embodiment, the method may treat abiraterone resistant prostate cancer. Yet another embodiment of the invention encompasses a method of treating prostate or other AR antagonist resistant cancer with a SARD compound of the invention wherein the androgen receptor antagonist(s) is at least one of enzalutamide, bicalutamide, abiraterone, ARN-509, ODM- 201, EPI-001, EPI-506, AZD-3514, galeterone, ASC-J9, flutamide, hydroxyflutamide, nilutamide, cyproterone acetate, ketoconazole, or spironolactone. [0034] These teachings read on instant claims 16, 17, and 19.
A method of treating enzalutamide resistant prostate cancer in a subject comprising administering to the subject a therapeutically effective amount of a compound according to any one of claims 1-11, or its isomer, pharmaceutically acceptable salt, pharmaceutical product, hydrate or any combination thereof. (Claim 21) These teachings read on instant claims 20 and 22.
A method of treating abiraterone resistant prostate cancer comprising administering to the subject a therapeutically effective amount of a compound according to any one of claims 1- 11, or its isomer, pharmaceutically acceptable salt, pharmaceutical product, hydrate or any combination thereof. (Claim 22) These teachings read on instant claims 20 and 24.
Ascertaining the differences between the prior art and the claims at issue:
Narayanan’s 1048 differs from the elected species 21c due to the presence of a nitrogen atom in the western ring.
Resolving the level of ordinary skill in the pertinent art:
Those of relevant skill in the art are those with the level of skill of the inventors of the references cited to support the Examiner’s positions.
Considering objective evidence present in the application indicating obviousness or nonobviousness:
Narayanan discloses selective androgen-receptor degraders (SARDs), exemplified by 1048, and teaches the very methods of treated prostate cancer recited here, including advanced/refractory disease, CRPC subtypes, antagonist-resistant tumors, and specified AR mutants. The reference also teaches routine co-therapies such as ADT/enzalutamide. As discussed above, 21c is an obvious variant of 1048 differing only by a phenyl to pyridyl substitution at the same ring position, a finite, predictable alternative expressly contemplated by Narayanan’s disclosure and well-known bioisosterism of -CH=/-N=. When presented with Narayanan’s explicit method of treatment framework for the specified patient populations and a lead compound (1048) together with a predictable, routine heteroaryl swap to arrive at 21c, the artisan would have been motivated to deploy 21c in the same method disclosed by Narayanan with a reasonable expectation of success. The artisan would expect that 21c would retain the same SARD mechanism, similar AR-directed pharmacology, and thus similar therapeutic effects across the disease subtypes and resistances Narayanan already teaches to treat.
Claims 1, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Narayanan in view of Fizazi (Fizazi, Karim et al. “Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer.” The New England journal of medicine vol. 377,4 (2017): 352-360. doi:10.1056/NEJMoa1704174) and Ponnusamy (found in IDS filed 12/07/2022).
Determining the scope of the prior art:
The teachings of Narayanan are discussed above and teach the limitations of claims 1 and 12. The above discussion is incorporated in its entirety into this rejection.
Fizazi teaches that the addition of abiraterone acetate and prednisone to androgen-deprivation therapy significantly increased overall survival and radiographic progression-free survival in men with newly diagnosed, metastatic, castration-sensitive prostate cancer (CSPC) (pg. 352, Conclusions). This teaching highlights that CSPC benefits when you add an AR-axis therapy, telling the artisan where to apply added AR control.
Ponnusamy teaches AR pan antagonist UT-34 was tested in competitive AR binding and transactivation assays (Abstract). UT-34 inhibits the wild-type and LBD-mutant ARs comparably and inhibits the in vitro proliferation and in vivo growth of enzalutamide-sensitive and -resistant prostate cancer xenografts. In preclinical models, UT-34 induced the regression of enzalutamide-resistant tumors at doses when the AR is degraded; but, at lower doses, when the AR is just antagonized, it inhibits, without shrinking, the tumors. This indicates that degradation might be a prerequisite for tumor regression (Abstract). These teachings show that an AR-degrader predictably strengthens AR pathway control.
Ascertaining the differences between the prior art and the claims at issue:
Narayanan does not teach a method of treating castration-sensitive prostate cancer.
Fizazi and Ponnusamy do not teach the same compounds used in the treatment of prostate cancer.
Resolving the level of ordinary skill in the pertinent art:
Those of relevant skill in the art are those with the level of skill of the inventors of the references cited to support the Examiner’s positions.
Considering objective evidence present in the application indicating obviousness or nonobviousness:
Narayanan teaches AR-directed SARD therapy for prostate cancer, and elected compound 21c is an obvious analog of 1048. Fizazi established that in metastatic castration sensitive prostate cancer the addition of AR-axis therapy to ADT significantly increased the overall survival of subjects. This provides a clear CSPC-on-ADT treatment framework, which would have been known to the artisan. Ponnusamy shows that AR degradation provides potent AR-pathway control in vivo, including tumor regression when AR is degraded. In view of these teachings, the artisan would have been motivated to implement Narayanan’s SARD approach with the CSPC-on-ADT setting and, because 21c is an obvious analog, would have reasonably expected that AR degradation would yield similar AR-mediated benefit in CSPC.
Claims 1 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Narayanan in view of Moilanen (Moilanen, Anu-Maarit et al. “Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signaling-directed prostate cancer therapies.” Scientific reports vol. 5 12007. 3 Jul. 2015, doi:10.1038/srep12007), Antonarakis (found in IDS filed 02/09/2023), and Ponnusamy.
Determining the scope of the prior art:
The teachings of Narayanan are discussed above and teach the limitations of claim 1. The above discussion is incorporated in its entirety into this rejection.
Moilanen teaches a F876L missense mutation in the LBD of the AR was identified to confer resistance to enzalutamide and ARN-509, an AR antagonist presently in a phase 3 study, by switching these antagonists to agonists (pg. 2, first para).
Antonarakis teaches Detection of AR-V7 in circulating tumor cells from patients with castration-resistant prostate cancer may be associated with resistance to enzalutamide and abiraterone (pg. 1028, Conclusions).
Ponnusamy teaches UT-34 inhibits the wild-type and LBD-mutant ARs comparably and inhibits the in vitro proliferation and in vivo growth of enzalutamide-sensitive and -resistant prostate cancer xenografts. In preclinical models, UT-34 induced the regression of enzalutamide-resistant tumors at doses when the AR is degraded; but, at lower doses, when the AR is just antagonized, it inhibits, without shrinking, the tumors. This indicates that degradation might be a prerequisite for tumor regression (pg. 6764, Results).
Ascertaining the differences between the prior art and the claims at issue:
Narayanan does not teach a method of treating darolutamide resistant prostate cancer.
Moilanen, Antonarakis, and Ponnusamy do not explicitly teach the same method using the same compounds for the treatment of prostate cancer.
Resolving the level of ordinary skill in the pertinent art:
Those of relevant skill in the art are those with the level of skill of the inventors of the references cited to support the Examiner’s positions.
Considering objective evidence present in the application indicating obviousness or nonobviousness:
Given Antonarkis’s association of AR-V7 with resistance to LBD-targeted AR agents and the LBD mechanism of darolutamide, and further recognizing that AR degradation overcomes antiandrogen resistance with tumor regression, the artisan would have been motivated to substitute a SARD such as 21c upon emergence of darolutamide resistance as a predictable, within-axis modification, with a reasonable expectation of success.
Claims 1 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Narayanan in view of Joseph (found in IDS filed 02/09/2023), Rathkopf (Rathkopf, D E et al. “Androgen receptor mutations in patients with castration-resistant prostate cancer treated with apalutamide.” Annals of oncology : official journal of the European Society for Medical Oncology vol. 28,9 (2017): 2264-2271. doi:10.1093/annonc/mdx283), and Ponnusamy.
Determining the scope of the prior art:
The teachings of Narayanan are discussed above and teach the limitations of claim 1. The above discussion is incorporated in its entirety into this rejection.
Joseph teaches that AR F876L is sufficient to confer resistance to ARN-509 and
enzalutamide in in vitro and in vivo models of castration-resistant prostate cancer (CRPC). Importantly, the AR F876L mutant is detected in plasma DNA from ARN-509–treated patients with progressive CRPC (Abstract, pg. 1021).
Rathkopf teaches AR F877L was not found in pretreatment samples but the mutation was detected in 3 (10%) post-apalutamide patients with a rising prostate-specific antigen (PSA), suggesting a possible mechanism for acquired treatment resistance (pg. 2265, left column second to last para.)
Ponnusamy teaches UT-34 inhibits the wild-type and LBD-mutant ARs comparably and inhibits the in vitro proliferation and in vivo growth of enzalutamide-sensitive and -resistant prostate cancer xenografts. In preclinical models, UT-34 induced the regression of enzalutamide-resistant tumors at doses when the AR is degraded; but, at lower doses, when the AR is just antagonized, it inhibits, without shrinking, the tumors. This indicates that degradation might be a prerequisite for tumor regression (pg. 6764, Results).
Ascertaining the differences between the prior art and the claims at issue:
Narayanan does not teach a method of treating darolutamide resistant prostate cancer.
Joseph, Rathkopf, and Ponnusamy do not explicitly teach the same method using the same compounds for the treatment of prostate cancer.
Resolving the level of ordinary skill in the pertinent art:
Those of relevant skill in the art are those with the level of skill of the inventors of the references cited to support the Examiner’s positions.
Considering objective evidence present in the application indicating obviousness or nonobviousness:
Given that AR F876L/F877L mediates apalutamide resistance and that AR degradation drives tumor regression in antiandrogen-resistant models, the artisan would be motivated to treat apalutamide resistant prostate cancer by administering a SARD such as 21c (a predictable, within-axis substitution) with a reasonable expectation of success.
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 1-4, 9, 10, 12, 20, 22, and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,314,797 in view of Narayanan.
Although the claims are not identical, they are not patentably distinct from each other because the ‘797 patent claims SARD compounds that are homologs of the elected compound 21c. ‘797 claims compound 1048
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which differs from the claimed compound 21c only in the western ring having a nitrogen atom present (see claim 11 of ‘797). It would have been obvious to substitute a -N= for -CH= in the ‘797 patent compound 1048 because the ‘797 patent also recites a genus of Formula I wherein X, which corresponds to the position in which the -CH= is placed in ‘797 patent compound 1048, is selected from CH or N:
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(‘797 patent claim 1). Accordingly, the selection of either CH or N as the X substituent would have been prima facie obvious to a person of ordinary skill in the art.
Claims 2 and 3 of ‘797 disclose structures IIA and IIB, respectively
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. These structures are identical to IIA and IIB of instant claim 2.
Claim 4 of ‘797 discloses structure II
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with the same limitations and structure as III
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of instant claim 3.
Claims 5 and 6 of ‘797 disclose IIA and IIB
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. These structures are identical to IIIA and IIIB of instant claim 4.
Claim 11 of ‘797 discloses species of SARD of formula I and includes 1048, which as previously discussed is an obvious homolog of 21c. This reads on instant claims 9 and 10 which disclose 21c.
Regarding claims 12, 20, 22, and 24, while the ‘797 patent does not claim any methods of using the compounds disclosed and claimed therein, it discloses “the invention” encompasses the same methods now claimed (Col. 19, 10 through Col. 20, 20). The instant fact pattern is similar to that found in the CCPA’s 1931 decision in In re Byck, the Federal Circuit’s 2010 decision in Sun Pharmaceutical Industries, Ltd., v. Eli Lilly & Co., Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC (Fed. Cir. 2003) and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2008). In Byck, the patent at issue claimed an insulated coil coated with a phenol-oil composition, but the patentee had already patented the same phenol-oil composition in a patent that disclosed its use for coating coils. In Sun, the patent at issue claimed methods of using gemcitabine for treating cancer, but the earlier patent claimed gemcitabine and taught that it was useful to treat cancer. In Geneva, the patentee claimed methods of using clavulanic acid for treating antibiotic-resistant bacteria, but owned an earlier patent that claimed clavulanic acid and disclosed its use against the same bacteria. In Pfizer, the patent at issue claimed methods of administering an anti-inflammatory drug, but the patentee had previously patented the same drug in a patent that disclosed its use in the same methods.
In Eli Lilly and Company v. Teva Parenteral Medicines, Inc., the Federal Circuit characterized these cases as representing “a limited exception:”
Byck, Geneva, Pfizer, and Sun thus “address the situation in which an earlier patent claims a compound, disclosing the utility of that compound in the specification, and a later patent claims a method of using that compound for a particular use described in the specification of the earlier patent.” …. Furthermore, in each of those cases, the claims held to be patentably indistinct had in common the same compound or composition—that is, each subsequently patented “use” constituted a, or the, disclosed use for the previously claimed substance. (Emphasis Added)
The instant case thus falls under the “limited exception” discussed in Eli Lilly and Company v. Teva Parenteral Medicines, Inc. because Applicants’ earlier patent (the ‘797 patent) claims SARD compounds substantially similar to the claimed SARD compound 21c and discloses the utility of those compounds for treating the same methods now claimed in the Specification. Applicants’ later application (the instant application) claims a method of using an obvious variant of the compounds claimed in the earlier ‘797 patent for particular uses described in the specification of the earlier ‘797 patent.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR KENNEDY ENGLISH whose telephone number is (571)270-0813. The examiner can normally be reached Monday Friday, 8 a.m. 5 p.m. ET..
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/C.K.E./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625