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 .
Information Disclosure Statement
The lined-through reference is simply an entire standard reference text. (Note 37 CFR 1.98(b)(5) “Each publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication [emphasis added], date and place of publication.”
112(a) Rejections Withdrawn
The rejection of claims 1-33 under 35 USC 112(a) or 35 USC (pre-AIA ), first paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. With respect to claim 15, the amendment cancels the claim. With respect to the remaining claims, the amendment narrows the scope of the claimed subject matter such that it is now enabled.
112(b) Rejections Withdrawn
The rejection of claims 1, 3-5, 8 and 9 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claims as appropriate.
The rejection of claims 2, 6, 7, 10-18 and 20-33 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action (indefinite from indefinite), is withdrawn. The rejection is moot. (The amendment cancels claim 15.)
Claim Rejections - 35 USC § 112(b), NEW
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 16 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.
It is unclear how a patient may be both treatment naїve (dependent claim 16) and “…has refractory or recurrent disease after previous treatment…” (independent claim 1).
Clarification is in order.
112(d) Rejections Withdrawn
The rejection of claim 8 under 35 USC 112(d) or 35 USC 112 (pre-AIA ), fourth paragraph, outlined in the previous Office Action, is withdrawn. Inventor’s argument has been carefully considered and is persuasive.
103 Rejections Withdrawn
The rejection of claims 1-10 and 19 under 35 USC 103, outlined in the previous Office Action, is withdrawn. With respect to claims 1-10, upon reconsideration and in light of inventor’s amendment, the rejection has been reformulated below. With respect to claim 19, the amendment narrows the scope of the claimed subject matter such that it no longer reads on the cited art.
Claim Rejections - 35 USC § 103, NEW
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.
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 1-10, 14, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over CN 112843238 A, whose English language machine translation has been relied upon for purposes of this Office Action, and further in view of Clin. Cancer Res. (2015), 21(1), pp. 60-67, cited in the IDS.
Inventor teaches a method for treating ovarian cancer comprising orally administering 150 mg (free base equivalent) of nirogacestat, or its pharmaceutically acceptable salt, twice daily, where the patient has refractory or recurrent disease after previous treatment, wherein the method comprises one or more of contingent limitations (a)-(e) (independent claim 1). Dependent claims 2-7 teach contingent limitations (f), (a), (b), (c), (d) and (e) respectively. Dependent claim 8 teaches contingent limitations (a)-(e). Dependent claim 9 teaches contingent limitations (a)-(f). Dependent claim 10 teaches a contingent limitation with respect to a dermatologic reaction. Dependent claim 14 teaches that the patient is an adult. Dependent claim 16 teaches that the patient is treatment naïve. (Note the 112(b) rejection of claim 16 above.) Dependent claim 17 teaches that the patient is a post-menopausal woman.
The examiner notes for clarity of the record that the broadest reasonable interpretation of a method or process claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. (Note MPEP 2111.04 II.)
CN 112843238 A teaches a method for improving the chemotherapeutic sensitivity of tumor patients – especially non-small cell lung cancer, ovarian cancer and breast cancer patients – to tubulin inhibitors by administering a composition comprising a Notch inhibitor and a tubulin inhibitor (English language machine translated abstract). PF-03084014 (i.e. nirogacestat) is one of 5 equivalent Notch inhibitors taught (page 2, text line 3; and claims, of the English language machine translated). That is, the reference teaches a method of treating ovarian cancer comprising administering PF-03084014 (i.e. nirogacestat).
Clin. Cancer Res. (2015), 21(1), pp. 60-67, a phase I dose-finding study, teaches that oral administration of PF-03084014 (i.e. nirogacestat) is safe and well tolerated at doses at or below 150 mg BID (i.e. 150 mg twice per day). Patients are adults with an age range of 23-80 and a median age of 61 (i.e. which for women would encompass post-menopausal women) (page 62, Table 1). Furthermore, patients may have refractory or recurrent disease after previous treatment, or be treatment naїve: “For inclusion in the study, patients had to have advanced solid tumors resistant to standard therapy or for which no therapy was available…” (page 61, column 1, Patients and Methods).
Inventor distinguishes over the method of ovarian cancer treatment taught by CN 112843238 A in that a particular twice-a-day dose (150 mg) of nirogacestat is taught. However, one of ordinary skill, before the effective filing date of the instant invention, would have found it obvious to employ the safe and effective dose taught by Clin. Cancer Res. (2015), 21(1), pp. 60-67, whose maximum is 150 mg twice per day. One of ordinary skill would be motivated to do so in order to provide an already demonstrated safe and effective dose of nirogacestat in the prior art method for the treatment of ovarian cancer.
Double Patenting Rejections Withdrawn
The provisional nonstatutory double patenting rejection of claims 1-10, over copending application 18/162,821, outlined in the previous Office Action, is withdrawn. Copending application 18/162,821 has since been abandoned (11/10/2025).
Allowable Subject Matter
Claim 19 is allowed. Claims 11-13, 18 and 20-33 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 3/22/2026