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
This application is a 371 of PCT/US2019/068771, filed December 27, 2019, and claims domestic benefit of U.S. Provisional Application No. 62/785,857, filed Dec. 28, 2018.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on Oct. 31, 2025 has been entered.
Claim Status
Claims 1-9 and 11-15 and are currently pending and subject to examination.
Claim Rejections – Withdrawn – Overcome by Amendment
The rejection of claims 1-6 under 35 U.S.C. 102(a)(1) as being anticipated by Besong et al. (US20180155351A1, Published June 7, 2018) is withdrawn.
The rejection of claims 1-9 under 35 U.S.C. 103 as being unpatentable over Besong et al. (US20180155351A1, Published June 7, 2018) is withdrawn.
The above rejections were overcome by Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 102 – New Grounds of Rejection Necessitated by Amendment
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.”
Claim(s) 1-6 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brain et al. (US 8,324,225, published Dec. 4, 2012) (of record, IDS 09/20/2021, cite no. 4).
Claim 1 is directed towards a compound of formula (I) or (II):
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. Claim 1 is anticipated because Brain teaches a compound of formula (I):
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(Brain, Specification, col. 175). As in formula (I), A is H; X and Y are N; S is
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; R is
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l ; R1 is
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,
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or
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; X or Z is CH; and R3 is H. Claims 2-6 and 11 read on the compound of Brain. As such, claims 1-6 and 11 are anticipated.
Claim Rejections - 35 USC § 103 – New Grounds of Rejection Necessitated by Amendment
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.
Claim(s) 1-6 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brain et al. (US 8,324,225, published Dec. 4, 2012) (of record, IDS 09/20/2021, cite no. 4), as applied to claims 1-6 and 11 above, and further in view of Besong et al. (US20180155351A1, Published June 7, 2018).
The rejection of claims 1-6 and 11 above as anticipated by Brain is incorporated herein by reference.
Claim 12 is directed towards the compound of claim 2, wherein R1 is
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, Z is CH or C-F and R6 is Me, isopropyl, isobutyl or bicyclo[1.1.1.]pentane.
As shown above, Brian teaches a compound of claim 2:
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(Brain, Specification, col. 175).
This compound differs from claim 12 in that R6 is H. One of ordinary skill in the art however, would have a reasonable expectation of success to substitute Me, isopropyl, or isobutyl for H because it similar CDK inhibitors are commonly known in the art.
For example, Brain teaches a similar CDK inhibitor wherein R6 is Me:
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(Brain, Specification, col. 50).
As another example, Besong teaches very similar compound wherein R6 is isobutyl or isopropyl:
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(Besong, Specification, p. 41, paragraph 0473)
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(Besong, Specification, p. 39, paragraph 0463).
Therefore, claim 12 was prima facie obvious at the time of filing.
Claim 13 reads on the compound
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(Brain, Specification, col. 175), but wherein R6 is methyl, isopropyl or isobutyl as in claim 12. As such, claim 13 is rejected for the reasons given in the rejection of claim 12 above.
Claim(s) 7-9 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Besong et al. (US20180155351A1, Published June 7, 2018) in view of Brain et al. (US 8,324,225, published Dec. 4, 2012) (of record, IDS 09/20/2021, cite no. 4).
Claims 7 and 15 are directed towards the compound A11:
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.
Besong teaches a largely similar CDK4 inhibitor compound which shares the same core features:
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(Besong, Specification, p. 39, paragraph 0463).
While the compound of Besong is largely similar to the claimed compound, it differs from A11 in having a pyridine group instead of fluorophenyl. While Besong does not teach fluorophenyl, one of ordinary skill in the art would have a reasonable expectation of success to substitute fluorophenyl for pyridine because it is known that both of these groups produce compounds with similar properties. For example, Brain teaches CDK inhibitors with either pyridine or fluorophenyl:
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(Brain, Specification, col. 151)
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(Brain, Specification, col. 156).
Therefore, claims 7 and 15 were prima facie obvious at the time of filing.
Claim 8 is directed towards a pharmaceutical composition comprising the compound A11 and one or more pharmaceutically acceptable excipients. One of ordinary skill in the art would have a reasonable expectation of success to formulate a pharmaceutical composition comprising the compound A11 because similar pharmaceutical compositions are commonly known in the art. For example, Besong teaches pharmaceutical compositions comprising similar CDK inhibitors and a pharmaceutically acceptable excipient:
“In another embodiment, the present invention includes a pharmaceutical composition comprising a compound of formula I or I(a) and a pharmaceutically acceptable carrier.
In another embodiment, the present invention includes a pharmaceutical composition comprising a compound of formula I or I(a) and a pharmaceutically acceptable carrier in a form suitable for oral administration.
The phrase “pharmaceutically acceptable” refers to molecular entities and compositions that are physiologically tolerable and do not typically produce an allergic or similar untoward reaction, such as gastric upset, dizziness and the like, when administered to a human. Preferably, as used herein, the term “pharmaceutically acceptable” means approved by a regulatory agency of the Federal or a state government or listed in the U.S. Pharmacopeia or other generally recognized pharmacopeia for use in animals, and more particularly in humans.
The term “carrier” refers to a diluent, adjuvant, excipient, or vehicle with which the compound is administered.”
Besong, Specification, page 4, paragraphs 0055-0058.
For example, Brain teaches pharmaceutical compositions comprising the compounds of their invention and a pharmaceutically acceptable excipient (Brain, Specification, col. 59, lines 30-37).
Therefore, claim 8 was prima facie obvious at the time of filing.
Claim 9 is directed towards a method of treating cancer or providing a chemotherapeutic effect comprising administering an effective amount of one or more of compounds including A11 to a subject in need thereof.
One of ordinary skill in the art would have a reasonable expectation of success to treat cancer with the compound A11 because structurally and functionally similar compounds are known to treat cancer. Besong teaches that the compounds of their invention are CDK inhibitors useful for the treatment of cancer:
The compounds of the formulae (I) or I(a) and sub-groups thereof are inhibitors of cyclin dependent kinases. For example, compounds of the invention are inhibitors of cyclin dependent kinases, and in particular cyclin dependent kinases selected from CDK1, CDK2, CDK3, CDK4, CDK5, CDK6 and CDK9, and more particularly selected from CDK1, CDK2, CDK3, CDK4, CDK5 and CDK9…
CDKs play a role in the regulation of the cell cycle, apoptosis, transcription, differentiation and CNS function. Therefore, CDK inhibitors could be useful in the treatment of diseases in which there is a disorder of proliferation, apoptosis or differentiation such as cancer. In particular RB+ve tumours may be particularly sensitive to CDK inhibitors. These include tumours harbouring mutations in ras, Raf, Growth Factor Receptors or over-expression of Growth Factor Receptors. Furthermore tumours with hypermethylated promoter regions of CDK inhibitors as well as tumours over-expressing cyclin partners of the cyclin dependent kinases may also display sensitivity. RB-ve tumours may also be sensitive to CDK inhibitors.”
Besong, Specification, page 7, paragraphs 0084 and 0087;
In another embodiment, the present invention includes a method of treating a disease, disorder or syndrome associated with CDK 4 inhibition, said method comprising administering a compound according to formula I or I(a) or its prodrug or pharmaceutical composition comprising the compound of formula I or I(a) or its prodrug and pharmaceutically acceptable excipients to a subject in need thereof.
In another embodiment, the present invention includes a method of treating a disease associated with CDK 4 inhibition, wherein the disease, disorder or syndrome is hyperproliferative in a subject, wherein subject is an animal including humans, selected from a group comprising cancer and inflammation.
Besong, Specification, page 4, paragraphs 0049-50.
For example, Brain teaches a method of treating cancer comprising administering the compound of their invention:
In another aspect, the invention provides a method of treating a protein kinase-associated disorder, wherein the method includes administering to a subject in need thereof a pharmaceutically acceptable amount of a compound of the Formula I, such that the protein kinase-associated disorder is treated. In one embodiment, the protein kinase is selected from the group consisting of CDK1, CDK2, CDK4, CDK5, CDK6, CDK7, CDK8, CDK9, Jak1, Jak2 and Jak3. In a particular embodiment, the protein kinase is selected from the group consisting of Jak3 and CDK4…
In another embodiment, the protein kinase-associated disorder is cancer. In yet another embodiment, the cancer is selected from the group consisting of breast, stomach, ovary, colon, lung, brain, larynx, lymphatic system, genitourinary tract (including bladder and prostate), ovarian, gastric, bone, and pancreatic cancer.
Brain, Specification, col. 3-4.
Therefore, claim 9 was prima facie obvious at the time of filing.
Given the above teachings, the invention as a whole was prima facie obvious at the time of filing.
Claim Objections
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HEATHER DAHLIN/Examiner, Art Unit 1629