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 .
Priority
This application is a national stage application under 35 U.S.C. § 371 of international
Application No. PCT/GB2020/053272, filed 12/18/2020, which claims the priority benefit of
UNITED KINGDOM Application No. 1918815.0, filed 12/19/2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/16/2022 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of the Application
Claims 1-2, 8-9, 18-20, 22-23, 31-32, 34, and 36-51 are pending. Claims 31, and 45-47 been amended. Claims 3-7, 10-17, 21, 24-30, 33, 35 have cancelled by applicant without prejudice or disclaimer. Claims 45-51 have been added. Claims 1-2, 8-9, 18-20, 22-23, 31-32, 34, and 36-51 are examined herein insofar as they read on the elected invention and species.
Applicant's arguments, filed 02/13/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. They constitute the complete set presently being applied to the instant application.
The anticipation and obviousness rejection below is repeated from the 11/14/2025 Final Rejection Office Action and modified in order to address the most recent amendments.
Claim Rejections - 35 USC § 112
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.
Claim 2 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2, lines 2-3 recites the broad recitation “or wherein R1 and R2 are each C1-4 alkyl,” and the claim also recites “preferably each methyl” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
This rejection may be overcome by amending the claim language of instant claim 2 to clearly define the limitations of R1 and R2 and satisfy the requirements of MPEP 2173.05(c) and 2173.05(d).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Dependent claim 19 includes the limitation of “and a platinum containing drug” which expands the scope of independent claim 1 which is drawn to a method for the treatment of platinum resistant cancer, comprising administering to a subject in need thereof a compound of formula (I) and makes no mention of administering any platinum containing compounds. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claims 36-40 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Dependent claim 36 includes the limitation of “and a platinum containing drug” which expands the scope of independent claim 1 which is drawn to a method for the treatment of platinum resistant cancer, comprising administering to a subject in need thereof a compound of formula (I) and makes no mention of administering any platinum containing compounds. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The dependent claims 37-40 are also rejected for being dependent on claim 36.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. 22-23, 31, 34, 43, and 45-51
Claims 1-2, 8-9, 18-20, 36-42, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Rice (US 7,994,172 B2) in view of Lamb (WO 2008/124161 A1).
The instant claims are directed to a method of treating platinum resistant cancer by administering a compound of formula (I) to a subject in need thereof.
Rice et al. teach a derivative of formula I as compound 29, N-[l-(3-bromo-1H-pyrazolo[3,4-d] pyrimidin-4-yl)piperidin-4-yl]-N-(4-chlorophenyl )-2-(diethylamino)ethane sulfonamide, (table 1, col. 23-24). Rice's compound 29 satisfies the limitations of the instant claims where X=CH, Z=N, Y=SO2 and R5=Br, R3=Cl and m=l, n=2 and R1 and R2 are each a C2 alkyl. Rice discloses compounds of formula (I) and methods for inhibition of kinases, more specifically and more preferably, Akt-1 andAkt-2 kinases (Abstract). Rice also teaches that a broad variety of cancers can be treated by compounds of the invention which also include serous ovarian carcinoma as a disease encompassed by the scope of the invention ( col. 72, lines 56-67 through col. 73 lines 1-41 ).
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Rice also discloses the "compositions will include a conventional pharmaceutical carrier or excipient and a compound of the invention as the/an active agent, and, in addition, may include other medicinal agents, pharmaceutical agents, carriers, adjuvants, etc. Compositions of the invention may be used in combination with anticancer or other agents that are generally administered to a patient being treated for cancer" (col. 76, lines 26-32). Rice teaches “AKT2 is amplified and overexpressed in ovarian cancer, and its overexpression contributes to the malignant phenotype of a subset of human ductal pancreatic cancers” (col. 3, lines 52-54).
However, Rice et al. fail to explicitly disclose a specific example of administering 1H-pyrazolo[3,4-d]pyrimidine compounds together with a platinum containing drug simultaneously or separately with a compound of formula I to treat a ovarian cancer.
Lamb et al. teach methods of treating cancer by administering a compound of Formula I, in combination with other cancer treatments (Abstract). Lamb discloses "Cancer" refers to cellular-proliferative disease states, including but not limited to: ovaries (ovarian carcinoma [serous cystadenocarcinoma, mucinous cystadenocarcinoma, unclassified carcinoma] [0084]. Lamb discloses administering a compound of formula I in combination with a treatment where the treatment is one or two chemotherapeutic agents where one of the chemotherapeutic agents is an AKT inhibitor selected from a compound in Table 2a, and a compound in Table 2b [00118]. Lamb also teaches 1H-pyrazolo[3,4-d]pyrimidin-4-yl)piperidine compounds on table 2a which are used as AKT inhibitors [00215]. Lamb also teaches an embodiment in which a method of treating ovarian cancer which method comprises administering to a patient a therapeutically effective amount of a Compound of Formula I in combination with one or more treatments where one of the treatments is one or two chemotherapeutic agents independently selected from a platinum-containing compound (including cisplatin, and carboplatin) [00179].
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the instant application, to administer Rice’s compound 29, N-[l-(3-bromo-1H-pyrazolo[3,4-d] pyrimidin-4-yl)piperidin-4-yl]-N-(4-chlorophenyl )-2-(diethylamino)ethane sulfonamide, identified as a suitable compound for a broad spectrum of cancers including a serous ovarian cancer to a subject with a platinum resistant ovarian cancer in need thereof with the teachings of lamb who also teaches 1H-pyrazolo[3,4-d]pyrimidine compounds for the treatment of ovarian cancer to include a combination therapy with carboplatin or cisplatin.
A person of ordinary skill in the art would have been motivated to use a compound of formula I in a combination cancer therapy administered to a patient with a platinum resistant ovarian cancer because Rice and Lamb both teach administering 1H-pyrazolo[3,4-d]pyrimidin-4-yl)piperidine compounds for the treatment of ovarian cancers. A skilled artisan would have also found administering a combination therapy with a combination of Rice’s formula I of the reference claims and a carboplatin or cisplatin following Lamb, would result in an effective ovarian cancer therapy with the predictable result of tumor growth inhibition or anti-proliferative effect. See MPEP 2144.06 Art Recognized Equivalence for the Same Purpose. Therefore, instant claims of 1-2, 8-9, 18-20, 36-42, and 44 are prima facie obvious to one of ordinary skill in the art at the time the invention was made, based on the current record.
Response to Arguments
Applicant argues GSK-690693 and Roche comp-4 are known AKT inhibitors, this does not take away from the inventiveness of the claimed compounds because the currently claimed compounds provide a structurally different approach to target these enzymes.
Rice’s disclosure of compounds of formula (I) and methods for inhibition of kinases, more specifically and more preferably, Akt-1 andAkt-2 kinases (Abstract). Rice’s compound 29 satisfies the structural limitations of applicants formula I of the instant claims and provides a structurally equivalent approach as the applicant to target these enzymes.
Applicant argues Rice also discloses a very long list of "cancers" at column 72, line 65 to column 73, line 58. However, there is no teaching in Rice regarding which, if any, of those cancers could be treated with a compound disclosed therein. Regarding ovarian cancer specifically, there is no specific teaching that the compounds in Rice may be used in the treatment of ovarian cancer, let alone platinum resistant ovarian cancer.
Rice discloses “compositions of the invention are used to treat diseases associated with abnormal and or unregulated cellular activities. Disease states which can be treated by the methods and compositions provided herein include, but are not limited to, cancer” (col. 4, lines 45-49). Rice also clearly cites that "Cancer" refers to cellular-proliferative disease states, including but not limited to: ovaries (ovarian carcinoma [serous cystadenocarcinoma, mucinous cystadenocarcinoma, unclassified carcinoma] (col. 72, line 65 through col. 73, line42). A skilled artisan following the teachings of Rice would have found it obvious to administer a compound of formula 1 which is already disclosed as useful in treating a variety of cancers to administer a compound of formula 1 to a patient with a platinum resistant cancer with an expectation of success at least for the reasons that no platinum is found in the compound of formula 1 and therefore its effectiveness against a platinum resistant cancer would not be hindered and that a compound taught as being useful in treating ovarian carcinoma [serous cystadenocarcinoma, mucinous cystadenocarcinoma, unclassified carcinoma], would have the predictable result of successfully treating a platinum resistant high-grade serous ovarian cancer. See MPEP 2111, MPEP 2112.01 and MPEP 2143(I)(E).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: Claims 22-23, 31, 34, 43, and 45-51 make a contribution over the prior art or record. The closest prior art found is taught by Rice who teaches the compound 29. The main difference between Rice’s compound 29 and the instant claims of claims 22-23 and 31-32, 34, 43, and 45-51 is at position n of substituent Y of formula II in independent claims 22, and 48 wherein the value of n is 0, 1, 3, or 4. The compounds of independent claims 31, 46-47 also make a contribution over the prior art of Rice’s compounds of formula I.
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Claims 48-51 are 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
Claims 1-2, 8-9, 18-20, 36-42, and 44 are rejected, Claims 48-51 are objected to, claims 22-23, 31-32, 34, 43, and 45-47 are allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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/E.V./Examiner, Art Unit 1623
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623