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 .
Election/Restrictions
Applicant’s election of compound of formula A, compound of formula M, breast cancer, and “anti-cancer treatment” in the reply filed on 07/31/2026 is acknowledged. Applicants did not specify if the election was made with or without traverse. Applicants also did not specify an additional therapy. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Examiner will search a biological therapy.
Claims 29-34, 36-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/31/2026.
Current Status of 18/845,872
This Office Action is responsive to the claims of 9/10/2024.
Claims 1-28, 35, and 39 are examined on the merits.
Priority
This application is a national stage entry of PCT/IB2023/054382 and also claims foreign priority to IN202241025286.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Therefore, the effective filing date for the instant claims is the international filing date of 04/29/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 27 is objected to because of the following informalities: There is a double comma in the second to last line of the claim. Appropriate correction is required.
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.
Claims 17-19, 20, 21, 24, 25, and 27 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.
Claim 17 recites the limitation “the PI3K inhibitor” in 6th line of the claim. Examiner is unsure if this limitation refers to Compound A (the PI3K inhibitor earlier in the claim) OR if claim 17 requires another different PI3K inhibition to be administered. The metes and bounds of claim 17 are unclear and thus indefinite.
Similarly, claim 17 also recites the limitation “SIK3 inhibitor”, in the 6th line of the claim. Examiner is unsure if this limitation refers to Compound M (the SI3K inhibitor earlier in the claim) OR if claim 17 requires another different SI3K inhibition to be administered. The metes and bounds of claim 17 are unclear and thus indefinite.
Claims 18 and 19 are similarly rejected to since these claims refer back to claim 17 but do not remedy the rationale underpinning the objection against claim 17.
Claim 17 is also rejected because it recites the limitation “or (iv) a pharmaceutical composition comprising (i), (ii), or (iii), by the oral, intravenous, intramuscular, or intraperitoneal route”. It is unclear if option (iv) is the only option which is delivered by the oral, intravenous, intramuscular, or intraperitoneal route OR if all options (i-iii) can be delivered via these routes. The metes and bounds of claim 17 are unclear and thus indefinite.
Claims 18 and 19 are similarly rejected to since these claims refer back to claim 17 but do not remedy the rationale underpinning the objection against claim 17.
Claim 19 also has a similar limitation “or (iv) a pharmaceutical composition comprising (i), (ii), or (iii) is administered in solid form”. It is unclear if option (iv) is the only option which is administered in solid form. The metes and bounds of claim 19 are unclear and thus indefinite.
Regarding claim 27, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 27, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 21 recites the broad recitation of “about 100 mg to about 2400 mg”, and the claim also recites other limitations, the narrowest of which is “about 100 mg to about 200 mg”, which is the narrowest 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.
Claim 20 also has a similar issue. Claim 20 recites the broad recitation of “about 25 mg to about 2400 mg”, and the claim also recites other limitations, the narrowest of which is “about 25 mg to about 200 mg”, which is the narrowest statement of the range/limitation.
Claim 24 also has a similar issue. Claim 24 recites the broad recitation of “about 200 mg to about 1200 mg”, and the claim also recites other limitations, the narrowest of which is “about 400 mg to about 800 mg”, which is the narrowest statement of the range/limitation.
Claim 25 recites the limitation “one or more cytostatic, cytotoxic, or anticancer agents”. It is unclear if the one or more applies to cytostatic agents or to cytostatic, cytotoxic, and anticancer agents. Therefore, the metes and bounds of claim 25 is unclear and thus indefinite.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 2, 4, 5-10, 13-15, 16-18, 25, 27, 35, and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by GOLDENBERG (US 20160296633 A1).
GOLDENBERG anticipates treating cancer (reference claim 1), more preferably, triple-negative breast cancer (TNBC) (paragraph [0004] and ref claim 35) comprising (which is open-ended claim language) administering an antibody or immunoconjugate and at least one therapeutic agent selected from the group consisting of … a PI3K inhibitor (reference claim 1). Also see Examples 3 and 4 on page 35. This anticipates claims 1, 5-10, 13-15, 16, 39 (human subject).
GOLDENBERG anticipates the elected species of PI3K inhibitor which is the instant compound of formula (A), referred to as RP6530 (ref claim 15). This anticipates claim 2.
GOLDENBERG anticipates a pharmaceutical composition containing an excipient (paragraphs [0206-0209]). This anticipates claim 4.
GOLDENBERG also anticipates the intravenous, intramuscular, and intraperitoneal routes of administration (paragraph [0206]). GOLDENBERG also anticipates that PI3K inhibitors can be administered orally (paragraph [0204]). This anticipates claims 17-18.
GOLDENBERG anticipates administering another anti-cancer treatment (an antibody or immunoconjugate in reference claim 1). This anticipates claim 25, a biological therapy of claims 27 and 35.
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 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.
Claim(s) 1-12, 13-15, 16-18, 25-28, 35, and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over GOLDENBERG (US 20160296633 A1) and in view of HANAFI (Hanafi et al., “Fludarabine Downregulates Indoleamine 2,3-Dioxygenase in Tumors via a Proteasome-Mediated Degradation Mechanism”, PLOS, June 9, 2014), and in view of Thorsteinn (Thorsteinn Loftsson, “Chapter 5- Pharmacologic response and Drug Dosage Adjustments”, A Primer for Pharmaceutical Scientists”, 2015).
GOLDENBERG teaches claims 1, 2, 4, 5-10, 13-15, 16-18, 25, 27, 35, and 39 above.
GOLDENBERG teaches treating cancer (reference claim 1), more preferably, triple-negative breast cancer (TNBC) (paragraph [0004] and ref claim 35) comprising (which is open-ended claim language) administering an antibody or immunoconjugate and at least one therapeutic agent selected from the group consisting of a PARP inhibitor and a PI3K inhibitor (reference claim 1).
GOLDENBERG teaches the elected species of PI3K inhibitor which is the instant compound of formula (A), referred to as RP6530 (ref claim 15). This teaches claim 2.
GOLDENBERG teaches the elected species the compound of formula M, referred to as fludarabine (claim 32) as an optional additional agent. This helps teach claim 3.
GOLDENBERG does not teach a combination of PI3K inhibitor and SIK3 inhibitor.
HANAFI teaches the efficacy of fludarabine, previously described to inhibit STAT1 phosphorylation, in suppressing protein expression and consequently IDO activity in a cell line derived from breast cancer (i.e. MDA-231 breast tumor cells) (abstract). Fludarabine is the elected species of SIK3 inhibitor, instant compound of formula M of claim 2.
HANAFI teaches that fludarabine impairs T cell dependent IDO upregulation (page 6). Fludarabine’s use in pre-treatment of patients prior to immunotherapies, which prevent IDO upregulation, which curtails tumor’s immuno-protective mechanism (page 6 and abstract).
The artisan would have been motivated to use Fludarabine/compound of formula M in treating breast cancer because GOLDENBERG teaches it can be used in its own combination treatment for solid tumors including breast cancer (ref claims 1, 15, and 32). Additionally, the artisan would expect that Fludarabine to have useful qualities when combining with GOLDENBERG’s combination (containing an immunotherapy), which would be expected to curtail tumor’s immuno-protective mechanism (page 6 and abstract). This teaches that Fludarabine would be useful in a breast cancer treatment.
The artisan would have found it obvious to combine Fludarabine, which is known to be a treatment for solid cancers (GOLDENBERG) and expected to be useful in breast cancer treatment (in view of HANAFI), with GOLDENBERG’s composition containing RP6530/compound of formula A, another known treatment for breast cancer (GOLDENBERG ref claims 1, 15). It is prima facie obvious to combine one breast cancer treatment with another in order to form a treatment to be used for the very same purpose (treating breast cancer). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). This teaches claims 1-4, 5-10, 13-15, 16,25, 27, and 35.
LOFTSSON teaches that dosage regimens are based on average pharmacokinetic parameters (page 120). LOFTSSON also teaches that these parameters may vary with patients’ gender, age, weight, and disease state (page 120). Furthermore, dosage adjustment is known (examples 5.1-5.4 on pages 120-124).
Furthermore, the artisan would have been motivated to optimize the dosage of composition containing RP6530/compound of formula A and Fludarabine and the times of the dosages (i.e. scheduling). It would be obvious to optimize the dosing regimen to maintain a therapeutic window and adjust for the impacts of disease state, age, weight, etc. (LOFTSSON pages 120-124). One would be motivated to adjust the regimen to maintain the therapeutic window, and would have a reasonable expectation for success in doing so, because this is something that is routinely practiced in the pharmaceutical arts. See MPEP 2144.05(II)A. Nothing in the specification or record appears to indicate the dosing regimen claimed is critical. In a combination, it would be obvious to have a single dose and give it to a patient once a day. This teaches claims 22-23.
It is obvious to administer the combination treatment to any breast cancer patient, because nothing precludes them from the treatment. This teaches claims 11-12, and 28.
The artisan would have expected to administer composition containing RP6530/compound of formula A and Fludarabine either sequentially or simultaneously from the natural conclusion that there are physically only two ways to administer two compounds, together at the same time or one after another. This teaches claim 26.
Conclusion
No claims are allowed as currently written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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