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 .
Application Status
The preliminary amendment filed on 9/15/2023 is acknowledged. Claims 1-22 are currently pending and under consideration.
Information Disclosure Statement
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
The specification is objected to because it contains an embedded hyperlink and/or other form of browser executable code (see for example, page 93). 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.
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.
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 1-22 are is/are rejected under 35 U.S.C. 103 as being obvious over Behenna et al. (US Patent No 11,718,603B2, 2023-08-08) in view of Caldron et al. (Mol. Cancer Ther; 2012; 11(7), 1488-1499).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Behenna et al. teach compounds of Formula I:
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which inhibit the activity of CDKs, including CDK2 (column 3, lines 1-66). Specifically, Behenna et al. teach a compound named (1R,3S)-3-[3-({[3-(methoxymethyl)-1-methyl-1H-pyrazol-5-yl]carbonyl}amino)-1H-pyrazol-5-yl]cyclopentyl propan-2-ylcarbamate monohydrate as a selective CDK2 inhibitor having the structure:
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. (column 5, lines 40-44, Claim 18 for example). Moreover, the US Patent teaches a pharmaceutical composition comprising a compound of formula I (claim 13 of the US Patent). The US Patent further teaches a method for the treatment of abnormal cell growth in a subject in need thereof, comprising administering to the subject a compound of formula I in combination with an amount of an additional therapeutic agent (e.g. an anticancer therapeutic agent), which amounts are together effective in treating said abnormal growth (column 29, lines 49-56). With regards to abnormal growth, the US Patent teaches that abnormal growth is cancer including, but not limited to, breast (column 30, lines 64+). With regards to breast cancer, the US Patent teaches that breast cancer includes, but is not limited to, HR positive, HER2-negative, endocrine resistant and breast cancer demonstrating resistance to CDK4/CDK6 inhibition (column 31, lines 10-21). With regards to an additional therapeutic agent, the US Patent provides numerous additional therapeutic agents including, but not limited to, endocrine agent such as letrozole, fulvestrant or tamoxifen or a signal induction inhibitor such as palbociclib (column 34, lines 19-27 and column 35, lines 52-57).
The US Patent does not specifically teach a composition comprising a compound of formula I in combination with a CDK4/CDK6 inhibitor such as palbociclib and further an additional therapeutic agent such as an endocrine agent or method of treating cancer using said composition.
Caldon et al. teach that CDK2 inhibitors decrease proliferation of tamoxifen-resistant cell lines and enhance the effects of CDK4 inhibition or tamoxifen treatment (page 1496, 1st column). For example, Caldon et al. teach that addition of SNS-032 (a CDK2 inhibitor) to PD0332991 (a CDK4 inhibitor) was more effective than PD0332991 alone in both MCF7 and TAMR cells (Figure 6B). Moreover, Caldon et al. teach that SNS-032 was more potent in the presence of 4-hydroxytamaxifen than alone in TAMR cells (Figure 6C). Note: As evidenced by the specification, PD0332991 is also known as palbociclib (spec, p. 18, lines 13-14).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to combine a CDK4/CDK6 inhibitor such as palbociclib and further an additional therapeutic agent such as an endocrine agent with the composition taught by the US Patent in view of the teachings of Caldon. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Caldon et al. CDK2 inhibitors enhance the effects of CDK4 inhibition or tamoxifen treatment.
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
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 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-21 of U.S. Patent No. 11,718,603B2 to Behenna et al. (2023-08-08) in view of Caldron et al. (Mol. Cancer Ther; 2012; 11(7), 1488-1499).
US Patent No. 11,718,603B2 claims a pharmaceutical composition comprising compounds of Formula I:
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(Claims 13-14). Specifically, claims a pharmaceutical composition comprising a compound named (1R,3S)-3-[3-({[3-(methoxymethyl)-1-methyl-1H-pyrazol-5-yl]carbonyl}amino)-1H-pyrazol-5-yl]cyclopentyl propan-2-ylcarbamate having the structure:
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. (Claim 18 for example). Moreover, the US Patent claims that the compound is a solvate, specifically a hydrate (claims 17 or 18 for example).
The US Patent differs from the instant claims in that the patent in that the composition of the patent is does not contain the compound of Formula I in combination with a CDK4/CDK6 inhibitor such as palbociclib and further an additional therapeutic agent such as an endocrine agent or method of treating cancer using said composition.
The portion of the specification of the US Patent that describes subject matter that falls within the scope of the claims may be relied upon to properly construe the scope of those claims, including all of the composition’s disclosed uses or utilities. (MPEP 804(II)(B)(1)). In Sun Pharm. v. Lilly, the Court affirms this use of the specification and states,
A ‘claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use,’ extends to any and all such uses disclosed in the specification of the earlier patent.
. . .
[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . . and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted.
611 F.3d 1381, 1387 (Fed. Cir. 2010).
In this case, the specification of the US Patent describes the utility of the composition to include the treatment of abnormal cell growth in a subject in need thereof, comprising administering to the subject a compound of formula I (column 29, lines 49-56). With regards to abnormal growth, the US Patent teaches that abnormal growth is cancer including, but not limited to, breast (column 30, lines 64+). With regards to breast cancer, the US Patent teaches that breast cancer includes, but is not limited to, HR positive, HER2-negative, endocrine resistant and breast cancer demonstrating resistance to CDK4/CDK6 inhibition (column 31, lines 10-21). The US Patent teaches compounds of Formula I:
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inhibit the activity of CDKs, including CDK2 (column 3, lines 1-66).
Caldon et al. teach that CDK2 inhibitors decrease proliferation of tamoxifen-resistant cell lines and enhance the effects of CDK4 inhibition or tamoxifen treatment (page 1496, 1st column). For example, Caldon et al. teach that addition of SNS-032 (a CDK2 inhibitor) to PD0332991 (a CDK4 inhibitor) was more effective than PD0332991 alone in both MCF7 and TAMR cells (Figure 6B). Moreover, Caldon et al. teach that SNS-032 was more potent in the presence of 4-hydroxytamaxifen than alone in TAMR cells (Figure 6C). Note: As evidenced by the specification, PD0332991 is also known as palbociclib (spec, p. 18, lines 13-14).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to combine a CDK4/CDK6 inhibitor such as palbociclib and further an additional therapeutic agent such as an endocrine agent with the composition claimed by the US Patent in view of the teachings of Caldon. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Caldon et al. CDK2 inhibitors enhance the effects of CDK4 inhibition or tamoxifen treatment.
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
Claims 1-4, 6-12, 14-16 and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 18/715,085 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and the reference application claim a method of treating cancer comprising administering a compound of formula I and a CDK4 inhibitor.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 18/715,080 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and the reference application claim a method of treating cancer comprising administering a PF-07104091, a CDK4 inhibitor and an endocrine therapy. Please note: PF-07104091 is the common name for the compound of claim 3 of the instant application referred to as (1R,3S)-3-[3-({[3-(methoxymethyl)-1-methyl-1H-pyrazol-5-yl]carbonyl}amino)-1H-pyrazol-5-yl]cyclopentyl propan-2-ylcarbamate (see disclosure of the reference application page 1, lines 5-8).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-6, 9, 11-14, 17, 19 and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8-12, 14, 16 of copending Application No. 17/995,619 (reference application) in view of Behenna et al. (US Patent No 11,718,603B2, 2023-08-08).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The reference application claims a method of treating cancer comprising administering to a subject in need thereof a therapeutically effective amount of a CDK2 inhibitor and a therapeutically effective amount of a CDK4/6 inhibitor, wherein the therapeutically effective amounts together are effective for treating cancer. With regards to the CDK4/6 inhibitor, the reference application claims that the CDK4/6 inhibitor is palbociclib.
The reference application does not claim that the CDK2 inhibitor is a compound of formula I as claimed in the instant application.
Behenna et al. teach compounds of Formula I:
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which inhibit the activity of CDKs, including CDK2 (column 3, lines 1-66). Specifically, Behenna et al. teach a compound named (1R,3S)-3-[3-({[3-(methoxymethyl)-1-methyl-1H-pyrazol-5-yl]carbonyl}amino)-1H-pyrazol-5-yl]cyclopentyl propan-2-ylcarbamate monohydrate as a selective CDK2 inhibitor having the structure:
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. (column 5, lines 40-44, Claim 18 for example). Moreover, the US Patent teaches a pharmaceutical composition comprising a compound of formula I (claim 13 of the US Patent). The US Patent further teaches a method for the treatment of abnormal cell growth in a subject in need thereof, comprising administering to the subject a compound of formula I in combination with an amount of an additional therapeutic agent (e.g. an anticancer therapeutic agent), which amounts are together effective in treating said abnormal growth (column 29, lines 49-56). With regards to abnormal growth, the US Patent teaches that abnormal growth is cancer including, but not limited to, breast (column 30, lines 64+). With regards to breast cancer, the US Patent teaches that breast cancer includes, but is not limited to, HR positive, HER2-negative, endocrine resistant and breast cancer demonstrating resistance to CDK4/CDK6 inhibition (column 31, lines 10-21). With regards to an additional therapeutic agent, the US Patent provides numerous additional therapeutic agents including, but not limited to, endocrine agent such as letrozole, fulvestrant or tamoxifen or a signal induction inhibitor such as palbociclib (column 34, lines 19-27 and column 35, lines 52-57).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the CDK2 inhibitor claimed in the method of the reference application with a compound of formula I in view of the teachings of Behenna et al.. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Behenna et al. teach that the compound of formula I is a CDK2 inhibitor useful for treating a variety of cancers including those that are resistant to CDK4 inhibitors.
Conclusion
Therefore, No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph McKane can be reached at 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626