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 .
According to paper filed on Feb. 3, 2026, the applicants have elected group II for further prosecution. However, the applicants did not elect specific species. During a telephone call with applicant’s attorney, Ms. Taylor N. Weilnau on March 12, 2026, the applicants elected compound BMS 303141 as specific species for further prosecution.
Claims 27-46 are pending in the application. Claims 27-34, 37-38 and 43-46 are withdrawn from further consideration as being directed to non-elected subject matter.
Claim Rejections - 35 USC § 112
4. 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 35-36 and 39-42 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.
In claims 35-36 and 39-42, the structures of candidate substance, first agent and second agent are not defined. The claim language is unclear. According to line 3, a candidate substance is treated to a separated biological sample while according to line 6, after treating with the candidate substance, and measuring - - -. It is not clear whether the candidate substance is being treated or biological sample is treated with candidate substance? It is also not clear whether the candidate substance is being administered to the biological sample or not. It is also not clear whether expression level or activity of one protein of either CAMMK2 or ATP citrate lyase is measured or one protein of both of CAMMK2 and ATP citrate lyase is measured?
Claim Rejections - 35 USC § 102
(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.
Claims 35-36, 39 and 42 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Mizogami (JP 2013-043862 A).
Mizogami discloses compositions for treating prostatic cancer, and screening method
of active ingredient in composition for treating prostate cancer. The method of screening
candidate wherein the candidate is CAMMK2 equivalent disclosed in claims 1-6 (see
page 4 of english translation) anticipates the instant claims when cancer is prostate
cancer.
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, 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.
9. 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.
10. Claims 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Mizogami (JP 2013-043862 A) in view of Kroemer (U.S. Patent 11,040,052 B2).
Mizogami discloses compositions for treating prostatic cancer, and screening method
of active ingredient in composition for treating prostate cancer. The method of screening
candidate wherein the candidate is CAMMK2 equivalent disclosed in claims 1-6 (see
page 4 of english translation) meets all the limitations of the instant claims when cancer
is prostate cancer except that Mizogami does not mention where autophagy is activated
in prostate cancer or prostate cancer comprises mutation in KRAS. However, Kroemer
teaches treating cancer including prostate cancer by hydroxycitrate (ATP citrate lyase
inhibitor) and also teaches that autophagy is activated in cancer or cancer comprises
mutation in KRAS (see claims 1 and 3-7). Therefore, it would have been obvious to one
skilled in the art to screen CAMMK2 equivalent for treating prostate cancer having
activated autophagy or prostate cancer comprising mutation in KRAS with reasonable
expectation of success.
11. Claims 35-36 and 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (U.S. Patent 9,060,993 B2) in view of Kroemer (U.S. Patent 11,040,052 B2).
Thompson discloses compositions and methods for treating cancer. The method of screening candidate wherein the candidate is hydroxy citrate (ATP citrate lyase inhibitor) disclosed in claims 1-2 and 18-22 by Thompson meets all the limitations of the instant claims when cancer is prostate cancer, bladder cancer, renal cancer, lung cancer or glioma except that Thompson does not mention increased expression of ATP citrate lyase and furthermore, where autophagy is activated in cancer or cancer comprises mutation in KRAS. However, Thompson does teach that in tumor cells, a feature of growing cells is the induction of a high level of ATP citrate lyase (see column 4, lines 12-40, specifically lines 12-14) and Kroemer teaches treating cancer including prostate cancer, bladder cancer, renal cancer, lung cancer or glioma by hydroxycitrate (ATP citrate lyase inhibitor) and also teaches that autophagy is activated in cancer or cancer comprises mutation in KRAS (see claims 1 and 3-7). Therefore, it would have been obvious to one skilled in the art to screen ATP citrate lyase inhibitor including hydroxycitrate and BMS 303141 by measuring high expression levels of ATP citrate lyase for treating cancer having activated autophagy or cancer comprising mutation in KRAS with reasonable expectation of success.
. IMPROPER MARKUSH GROUP
12. Claims 35-36 and 39-42 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 35-36 and 39-42 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: In the prior art, Granchi (Eur. J. Med. Chem., cited on applicant’s form 1449) discloses various ATP citrate lyase inhibitors having diverse structures (see figures 5, 6 and 7 on pages 21, 28 and 32, respectively). There is no common structural core present between these ATP citrate lyase inhibitors. Furthermore, the instant claims are directed to compounds of unknown structures, antibodies, RNA, DNA, enzymes, polypeptides etc. also in addition to ATP citrate lyase inhibitors (see claim 36). Therefore, the claims 35-36 and 39-42 lack a common structural core as well as common use.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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