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 .
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.
Current Status of 18/547,410
This Office Action is in response to the amended claims of 02/10/2026.
Claims 1-2, 4, and 6 are original; claims 3, 5, 7-8, 11,14 and 18-21 are previously presented; claims 23-27 are new; claims 9, 15, 17 and 22 are currently amended.
Claims 1-9,11, 14-15 and 17-27 are examined in this office action.
Priority
The effective filing date is 03/03/2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendment and remarks of 02/10/2026. Examiner have reviewed these remarks and amendments.
Applicant submitted certified copy of foreign priority document; however, applicant did not provide certified translation of the foreign document. Therefore, priority date is 03/03/2022.
Regarding 112 rejection, applicant canceled claim 10 and deleted the phrase “suitable” from claims 9 and 22, thus overcoming the rejection. 112 rejections are withdrawn.
Regarding 103 rejection:
Applicant argues:
The method of treating or preventing breast cancer with the CDKK4/6 inhibitors (different from formula I) + endocrine therapy in the prior art is conducted in mice, not in human.
In the remarks applicant claims the composition of formula (I) with fulvestrant have
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(page 8 of the remarks) good safety and desired clinical benefits compare to other CDK4/6 inhibitor + fulvestrant. Applicant further provided data with exhibits 2, 3 and 4 where the prior art showed adverse effect of combination of other CDK4/6 inhibitors + fulvestrant (please see page 8-10 of the remarks) compared to formula (I)+ fulvestrant.
Examiner Response.
The claims do not distinguish between mice and human subject for treatment. Therefore, applicant argument regarding different subject is not convincing, and does not advance the prosecution for allowance.
Applicant provided evidence in exhibit 2, 3 and 4 where applicant asserts CDKK4/6 inhibitors and fulvestrant does not have good safety profile. Incidence rate of TEAES(Treatment Emergent Adverse Events) of grade 3 or more is 39.2 % with formula (I)+ fulvestrant compared to other CDKK4/6 inhibitors + fulvestrant (please see page 8-10 of the remarks). Applicant further claims incidence rate of TEAES(Treatment Emergent Adverse Events) of grade 3 or more is 39.2 % with formula (I)+ fulvestrant surprising, however these results are not reflected in the specification. The specification have support for incidence rate of TEAES(Treatment Emergent Adverse Events) of grade 3 or more is 39.2 % with formula (I)+ fulvestrant, but this no comparison studies with other CDK4/6 inhibitor + fulvestrant. Therefore, there is not sufficient evidence in the specification for surprising and unexpected results. Therefore 103 rejection is maintained.
Applicant is encouraged to file declaration of affidavit to overcome 103 rejection, with evidence of surprising and unexpected results by comparing exhibits 2, 3 and 4 with formula (I)+ fulvestrant.
Claim Rejections - 35 USC § 103(maintained)
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 1-9, 11, 14-15, and 17-27 are rejected under 35 U.S.C. 103 as being unpatentable over
SUN, Piao-yang, et.al (CN-107137409-A).
In view of
Ding; Charles Z. (US-9969719-B2)
In further view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of the prior art.
Sun et.al. discloses the use of a CDK4/6 inhibitor (same as compound of formula (I) )in combination with an estrogen receptor antagonist in preparation of a medicament for treating a breast cancer, wherein the estrogen receptor antagonist is fulvestrant (see abstract), the breast cancer(partially teaching claim 14, 24) is estrogen receptor positive (ER+) (reference claim 3) breast cancer or human epidermal growth factor receptor 2 negative (HER2-) (reference claim 4) breast cancer ( teaching claim 15, and 24-25), the breast cancer is locally advanced or metastatic breast cancer(reference claim 5) , and the dose of the estrogen receptor antagonist is 100-1000 mg (reference claim 10) ( same range in claims 5, 7-9, 18-20 and 22 for fulvestrant) per use. Thus, partially teaching claim 1-2, 5-9,11, 14-15 and 18-27.
Ding et.al discloses that the compound of formula (I) in claim 1 has CDK4/6 inhibitor activity (column 41 example 3, and column 121 lines 19-50) in breast cancer partially teaching claims 1-4, 7-9,11, 14-16, 19-27.
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Sun et.al. does not teach combined composition comprising compound of formula (I) with fulvestrant and the dosage of compound of formula (I) with dosage of fulvestrant.
Ding et.al. does not teach combined composition comprising of compound of formula (I) with fulvestrant and the dosage of compound of formula (I) with dosage of fulvestrant.
Anisel et.al. does not teach combined composition comprising of compound of formula (I) with fulvestrant and the dosage of compound of formula (I) with dosage of fulvestrant.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing treatment modality for breast cancer
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to combine prior art of Sun et.al. which teaches composition of CDK4/6 inhibitor in combination with fulvestrant (Sun see abstract, claim 1) for treating breast cancer with estrogen receptor positive (ER+) breast cancer or human epidermal growth factor receptor 2 negative (HER2-) breast cancer ( teaching claims 14-15 and 24-25), wherein the breast cancer is locally advanced or metastatic breast cancer( Sun et.al. reference claim 3-5) teaching claims 14-15; with the teaching of Ding et.al. which teaches compound of formula (I) as CDK4/6 inhibitor for breast cancer because the combination of compound of formula (I) and fulvestrant is expected to treat breast cancer. It would be obvious for a person skilled in the art to replace CDK4/6 inhibitor in Sun et.al. with compound of formula (I) since compound of formula I is also a CDK4/6 inhibitor that can treat breast cancer(Ding et.al. column 41 example 3, and column 121 lines 19-50). Therefore, compound of formula (I) with fulvestrant is expected to have same or better effect in treating breast cancer. Therefore, it would be obvious for a person skilled in the art to develop a pharmaceutical composition comprising with combined compound of formula (I) with fulvestrant to treat breast cancer thus teaching all the element for claims 1-2 and 14-15.
Claims 3-9,11, 17-22 and 27 are directed to dosage and frequency of the dosage of compound of formula (I) and fulvestrant. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be critical. “[W]here 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) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Conclusion
No claims are allowable as written.
Applicant is encouraged to file declaration of affidavit to overcome 103 rejection.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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