DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Request for Continued Examination (RCE), Amendments and Remarks, filed 24 March 2026, in the matter of Application N° 17/913,033. Said documents have been entered on the record. The Examiner further acknowledges the following:
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 8, 2025 has been entered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No claims have been added.
Claim 23 appears to have been canceled, at least according to its status indicator. The subject matter has been lined through, but remains present in the claim set. Applicants’ are directed to MPEP §714 regarding the compliant manner in which claims are to be amended. The claim will be considered canceled. However, the subject matter should be removed in its entirety.
Claims 1, 4-6, 25, 35, and 44 have been amended.
As with claim 23, Applicants are again directed to MPEP §714 regarding proper claim status indicators. The indicator for claim 4 should read, for instance: “(Currently Amended)”.
The amendments to claim 1 are the addition of structures to the R1 variable, and a narrowing of the previous definitions to R5a and R5b. The added structures are supported by the originally-filed disclosure (see pg. 26, line 30 to pg. 27, line 25, and pg. 80). The same support is relied upon for the amendments to claims 5, 6, and 35. Claim 35 has also been amended to remove any structures defining R1 as an indolyl group. Claim 44 has been amended to clarify the recited method.
No new matter has been added.
Thus, claims 1, 4-6, 10, 12, 13, 16, 19, 25, 32-35, 37, 38, 41, 44, and 45 now represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statement(s) (IDS) have been filed for consideration.
Withdrawn Rejections
Rejections under 35 USC 112
Applicants’ amendments to claims 35 and 44 are persuasive in overcoming the previously raised indefiniteness rejections. Said rejections are withdrawn.
Rejection under 35 USC 102
Applicants’ amendments to claims 1, 5, 6, and 35, discussed above are persuasive in overcoming the previously raised anticipation rejection over Foote. Said rejection is withdrawn.
Rejection under 35 USC 103
Applicants’ amendments to claims 1, 5, 6, and 35, and remarks to the rejection have been fully considered. Though not persuasive, the current rejection is withdrawn and remade below to clarify the grounds as to why the instantly amended invention continues to be rendered prima facie obvious. The current rejection is withdrawn.
New Rejections
Applicants’ amendments have necessitated the following ground(s) of rejection:
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 45 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.
Regarding claim 45, the phrase “plasma cell neoplasm (myeloma)” renders the claim indefinite because it is unclear whether the parenthetical limitation following the phrase is part of the claimed invention. See MPEP §2173.05(d), regarding “such as” limitations.
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.
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.
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. Applicants are 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, 4-6, 10, 12, 13, 16, 19, 25, 32-35, 37, 38, 41, 44, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Dishington et al. (US Pre-Grant Publication Nº 2011/0334454 A1).
As amended, Formula I’ is defined by the following core formula:
PNG
media_image1.png
382
278
media_image1.png
Greyscale
In addition to the previously recited structures for R1, claim 1 now recites that the variable may also be embodied by furyl, imidazolyl, triazolyl, triazinyl, oxazoyl, isoxazoyl, thiazolyl, isothiazolyl, pyraxolyl, pyrrolyl, pyrazinyl, tetrazolyl, pyridyl, thientinyl, pyrimidinyl, pyridazinyl, isoquinolyl, quinolyl, isoindolinyl, quinoxalinyl, quinazolinyl or indazole groups. The R5a and R5b variables have also been narrowed to combine to form a carbonyl, a C3-C8 cycloalkyl, or a C2-C7 heterocycloalkyl together with the atom to which they are attached.
The claim continues to exclude compounds: AZD6738, AZ20, and AZD3147.
Dishington (see e.g., Abstract; claim 1) discloses the following core compound:
PNG
media_image2.png
276
268
media_image2.png
Greyscale
,
further defining 1Y and Y2 as being independently N or CR8 provided that one of 1Y and Y2 is N and the other is CR8. Here, 1Y is CR8 reading on instant variable X3 and Y2 is N reading on instant X2. The R8 variable is further defined as being hydrogen, thereby making CR8 read as -CH-. Instant X1 is a fixed definition in the reference as N.
The ‘X’ variable is defined by Dishington as being a linker group such as -S(O)2CR6R7-. The R1 variable is defined as including NR9R10, with R9 and R10 being further defined as hydrogen, thereby reading as -NH2.
Variables R6 and R7 are defined in the claim as being independently selected from hydrogen, halo, cyano, nitro, and C1-C6 alkyl. Here, the Examiner concedes that while disclosure of C1-C6 alkyl does not expressly disclose a C3 cycloalkyl group as instantly claimed, it is included as C1-C6 alkyl is considered to be generic towards this structure. The Examiner further submits that the claimed C3 cycloalkyl is taught and suggested by the reference. Paragraph [0124] is noted as disclosing that “[s]uitable values for any R group or any part or substituent for such groups include: … for C3-6 cycloalkyl, cyclopropyl, cyclobutyl…” Such is considered by the Examiner as teaching that the C1-C6 alkyl may be embodied by a C3 cycloalkyl group, thereby disclosing the following substructure:
PNG
media_image3.png
200
400
media_image3.png
Greyscale
The R3 variable in the formula of Dishington is defined as being -R13, which is further defined as being a C1 alkyl and ‘m’ may be defined as 1 (i.e., methyl).
Lastly, R2 of Dishington is taught as being defined and optionally substituted with such groups as: pyridinyl, halo (e.g., -Cl), and -SR11, wherein R11 is further defined as being a C1 alkyl (i.e., methyl).
The foregoing is considered to teach and suggest the following compounds recited by instant claim 35:
PNG
media_image4.png
142
168
media_image4.png
Greyscale
PNG
media_image5.png
138
326
media_image5.png
Greyscale
The foregoing compounds and definitions read on the limitations of instant claims 1, 4-6, 10, 12, 13, 16, 19, 25, and 32-35.
The practiced compositions of Dishington are additionally disclosed as being formulated into pharmaceutical compositions using a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, thereby disclosing the limitations of claim 37 (see e.g., Abstract; ¶[0160]).
The reference is also considered to teach the recited method of treatment of a disorder of uncontrolled cellular proliferation (aka cancer) (see e.g., claim 21). Paragraph [0518] further discloses that “inhibitors of mTOR kinase and/or one or more PI3K enzymes should be of therapeutic value for the treatment of proliferative disease such as cancer and in particular solid tumours such as carcinoma and sarcomas and the leukaemias and lymphoid malignancies and in particular for treatment of, for example, cancer of the breast, colorectum, lung (including small cell lung cancer, non-small cell lung cancer and bronchioalveolar cancer) and prostate, and of cancer of the bile duct, bone, bladder, head and neck, kidney, liver, gastrointestinal tissue, oesophagus, ovary, pancreas, skin, testes, thyroid, uterus, cervix and vulva, and of leukaemias [including acute lymphoctic leukaemia (ALL) and chronic myelogenous leukaemia (CML)], multiple myeloma and lymphomas.”
The foregoing is considered to teach the limitations of claims 38, 41, 44, and 45.
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition and arriving at the recited method of treatment. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1, 4-6, 10, 12, 13, 16, 19, 25, 32-35, 37, 38, 41, 44, and 45 under 35 USC 103(a) as being unpatentable over the combined teachings of Dishington et al. have been fully considered, but they are not persuasive.
Applicants traverse the rejection on the grounds that “[t]here is no suggestion to use a carbonyl or cyclic group at this [i.e., the R6 and R7 position] throughout Dishington”.
The Examiner, in response, respectfully disagrees and submits that a C3 cycloalkyl is taught and suggested by the reference as discussed in the rejection above.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
Prosecution Insights