NON-FINAL REJECTION
This application is a 35 U.S.C. 371 (national stage) application of PCT/IB2022/061525, filed Nov. 29, 2022, which claims benefit of priority to Provisional Applications 63/285,320, filed Dec. 2, 2021; 63/382,346, filed Nov. 4, 2022; and 63/383,969, filed Nov. 16, 2022.
Claims 1-18 and 23-25, as amended, are pending.
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
Applicant' s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Oct. 1, 2024 and Jun. 22, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Election/Restrictions
Applicant's election with traverse of the method species of claim 7 (methods of treating cancer by administering a composition comprising PF-07220060 (a.k.a. atirmociclib) and an endocrine therapy agent; breast cancer as the species of cancer; and letrozole as the species of endocrine therapy agent, in the reply filed on Aug. 13, 2026 is acknowledged. The traversal is on the ground(s) that it would not be an undue burden to search all claims and species of the invention (Remarks, p. 5).
Applicant further submits that the pending claims are directed to closely related embodiments of a common inventive concept involving treatment of cancer with PF-07220060. The claims are directed to related aspects of the same invention and share substantial common subject matter (Remarks, p. 5).
This is not found persuasive because search burden is not a consideration in unity of invention practice under 35 U.S.C. § 371 and 37 C.F.R. 1.499. See also MPEP §§ 1850, 1893.03(d), and 1896.
In addition, the species common to the independent claims do not present a contribution over the prior art, as disclosed by Chen et al. Thus, despite sharing common subject matter, the species recited by independent claims 1 and 7 lack the same or corresponding special technical features.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on Aug. 13, 2026.
Claims 2-17 and 23-25 are currently pending and under consideration.
Claim Rejections - 35 U.S.C. § 112(b) - Indefiniteness
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 2-10, 12-17, and 23-25 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.
The claims are drawn to a method of treating cancer comprising administering to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising PF-07220060 and an endocrine therapy agent to a subject in need thereof.
The phrase “administering . . . a pharmaceutical composition comprising PF-07220060 and an endocrine therapy agent” is unclear because one of ordinary skill in the art could reasonably interpret it in two different ways:
administering a pharmaceutical composition comprising BOTH PF-07220060 and an endocrine therapy agent; or
administering (1) a pharmaceutical composition comprising PF-07220060, and, separately, administering (2) an endocrine therapy agent.
Because one of ordinary skill in the art could not unambiguously determine which of these two interpretations is intended by Applicant, infringing methods cannot be distinguished from non-infringing methods, rendering the metes and bounds of the claims indefinite.
Note: claim 11 is excluded from this rejection because it recites administration of the endocrine therapy agent, followed by subsequent administration of PF-07220060. Thus, claim 11 is clearly directed to separate administration of the two claimed compounds.
Claim Rejections - 35 U.S.C. § 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 2-17 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US Pub. 2020/0354350, cited on the IDS dated 10/1/2024).
Chen et al. disclose and claim methods for treating breast cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of Compound A94 (PF-07220060; atirmociclib), or a pharmaceutically acceptable salt thereof (claims 21-22):
Chen et al. Compound A94
Claimed compound
PF-07220060; atirmociclib
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212
270
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180
264
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wherein the breast cancer is hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer (claims 23-24), further comprising administering to the subject an additional anti-cancer agent (claim 25), which is an endocrine agent, e.g., an aromatase inhibitor (claim 26), which is letrozole or fulvestrant (claim 27).
Thus, Chen et al. disclose, teach, and suggest a method of treating breast cancer comprising administering to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising PF-07220060 and letrozole as an endocrine therapy agent to a subject in need thereof, as recited by claims 7-10, 16, and 17.
The methods of Chen et al. include administering the disclosed compounds in a continuous dosing regimen (para. [0924]), as recited by claim 5.
Chen et al. disclose the administration of PF-07220060 in tablet or capsule form (paras. [0968]-[0984]), as recited by claim 6.
Chen et al. disclose that the additional anti-cancer agent (e.g., letrozole) is administered prior to administration of the disclosed compounds (para. [1016]), as recited by claim 11.
The compounds of Chen et al. are disclosed to be administered as a second or later line therapy following treatment with one or more chemotherapy regimens (para. [0934]); i.e., wherein the subject has been previously treated with chemotherapy, as recited by claim 12.
The compounds of Chen et al. are disclosed to be administered as a second or later line therapy following treatment with a CDK4/CDK6 inhibitor (para. [0934]), i.e., wherein the subject has been previously treated with a CDK4/6 inhibitor, as recited by claim 13.
The compounds of Chen et al. are disclosed to be administered as a second or later line therapy following treatment with an endocrine therapeutic agent (para. [0934]), i.e., wherein the subject has been previously treated with an endocrine therapy agent, as recited by claim 14.
Chen et al. disclose methods of administering the combination therapy to a mammal, e.g.,
a human (para. [1016]), as recited by claim 15.
Chen et al. differs from the claims in that administering an amount of PF-07220060 from about 100 mg to about 500 mg BID is not exemplified.
However, Chen et al. disclose that, for a 70 kg human, an effective dosage is typically in the range of about 10 mg/day to about 1000 mg/day (para. [1009]), e.g., about 200mg/day, or about 1000 mg/day (para. [1010]), with larger doses typically divided into several smaller doses for administration throughout the day (para. [1011]), e.g., BID (twice a day).
Thus, Chen et al. disclose, teach, and suggest methods of administering a therapeutically effective amount of PF-07220060 (paras. [1009]-[1011]), which includes:
about 300 mg to about 500 mg BID, as recited by claim 2;
about 300 mg BID, as recited by claim 3;
about 400 mg BID, as recited by claim 4;
about 100 mg to about 400 mg BID, as recited by claim 23;
about 100 mg, as recited by claim 24; and
about 200 mg, as recited by claim 25.
Chen et al. disclose various dosage ranges, with the amount of active compound administered dependent on the subject being treated, the severity of the disorder or condition, the rate of administration and disposition of the compound, and the discretion of the prescribing physician (paras. [1009]-[1011]).
Chen et al. disclose that dosage values may vary with the type and severity of the condition to be alleviated and may include single or multiple doses. Specific dosage regimens should be adjusted over time according to the individual need and the professional judgment of the person administering or supervising the administration of the compositions. Doses may be adjusted based on pharmacokinetic or pharmacodynamic parameters, and encompasses intra-patient dose-escalation as determined by the skilled artisan. Determining appropriate dosages and regimens for administration of the chemotherapeutic agent are well-known in the relevant art and would be understood by the skilled artisan (para. [0964]).
Therefore, it would have been predictable to one of ordinary skill in the art as of the filing date to optimize the dosage amounts taught by Chen et al. to arrive at the claimed dosage regimens with a reasonable expectation of success, because the amount of drug administered and the frequency of administration are result-effective variables which determine the therapeutic outcome and can be optimized by routine experimentation.
As recognized by MPEP § 2144.05,
Generally, differences in concentration or tempera-ture will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Further, as recognized by MPEP § 2144.05 (I), in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,16 USPQ2d 1934 (Fed. Cir. 1990).
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 2-17 and 23-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-16 of U.S. Patent No. 11,220,494. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims and the examined claims share the identical active step of administering PF-07220060 and letrozole to treat breast cancer.
The reference claims are drawn to a method for the treatment of cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of PF-07220060, or a pharmaceutically acceptable salt thereof, wherein the cancer is, e.g., breast cancer;
wherein the breast cancer is hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer, wherein the breast cancer is advanced or metastatic breast cancer;
further comprising administering to the subject an additional anti-cancer agent, e.g., an aromatase inhibitor, e.g., letrozole;
wherein the PF-07220060 is administered as a first line therapy, or as a second or later line therapy.
The reference claims differ from the examined claims in that the reference claims recite administering a therapeutically effective amount of PF-07220060, rather than a specific dosage of about 100 mg to about 500 mg BID; about 100 mg to about 400 mg BID; about 300 mg to about 500 mg BID; about 100 mg; about 200 mg; about 300 mg; or about 400 mg, as recited by examined claims 2-4, 7, and 23-25.
However, the reference patent defines “a therapeutically effective amount” of PF-07220060 (col. 87, lines 37-58) as:
that amount which has the effect of (1) reducing the size of the tumor, (2) inhibiting (that is, slowing to some extent, preferably stopping) tumor metastasis, (3) inhibiting to some extent (that is, slowing to some extent, preferably stopping) tumor growth or tumor invasiveness, (4) relieving to some extent (or, preferably, eliminating) one or more signs or symptoms associated with the cancer, (5) decreasing the dose of other medications required to treat the disease, and/or (6) enhancing the effect of another medication, and/or (7) delaying the progression of the disease in a patient.
Thus, while the reference claims do not explicitly recite a numerically quantified amount of PF-07220060, the term “therapeutically effective amount” is defined to encompass the same therapeutic effects achieved with the dosages recited by the examined claims.
Therefore, it would have been predictable to one of ordinary skill in the art as of the filing date to optimize the dosage amounts taught by Chen et al. to arrive at the claimed dosage regimens with a reasonable expectation of success, because the amount of drug administered and the frequency of administration are result-effective variables which determine the therapeutic outcome and can be optimized by routine experimentation.
As recognized by MPEP § 2144.05,
Generally, differences in concentration or tempera-ture will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Further, as recognized by MPEP § 2144.05 (I), in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,16 USPQ2d 1934 (Fed. Cir. 1990).
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure:
WO 2022/103834 (cited on PTO-892).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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