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 .
DETAILED ACTION
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-3, 5-6, 10-11, 24-25, 32-36, and 68 have an effective filing date of 01DEC2017.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/09/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restriction
In the response filed on 4/01/2026, Applicant elected:
A TRPV inhibitor peptide comprising SEQ: 2
An antagonist of an inhibitory immune checkpoint molecule
A PD-1 inhibitor
Prostate cancer
Status of Claims
Claims 1-3, 5-6, 10-11, 24-25, 32-36, and 68 are currently pending and presented for examination on the merits.
Claims 24-25 are withdrawn from further consideration by Examiner under 37 CFR 1.142(b) as being drawn to a non-elected species.
Claims 1, 3, 5-6, 10-11, 24-25, 32-36, and 68 are amended.
Claims 4, 7-9, 12-23, 26-31, 37-67, and 69-70 are canceled.
Objection to the Drawings
The drawings are objected to, because Fig. 1 is blurry and difficult to read. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claims Objections
Claim 3 is objected to for reciting tables and figures. MPEP 2173.05(s) states:
“Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table ‘is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.’ Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).”
In this case, sequences of TRPV6 inhibitors that the table refer to could easily be incorporated into the claims to define the invention. Appropriate correction is required.
Claim Rejections 35 U.S.C. 112(b)
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 5 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.
Claim 5 recites TRPV6 inhibitor peptide is about, less than about, or no more than about 10, 11, 12, 13, 14, 15… amino acids in length. Due to the “about, less than about, or no more than about” language, one skilled in the art would not be reasonably informed with respect to how many amino acids are encompassed by the claimed TRPV6 inhibitor peptide. Therefore one skilled in the art would be unable to readily identify the metes and bounds of the claim.
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.
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 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.
Claims 1-3, 5-6, 10-11, 32-36, and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al (20120316119 A1, IDS 05/09/2024), and further in view of Ruggero et al (New Antitumoral Pharmacological Strategies Involving Ca2+/Camp Signaling Pathways, Journal of Cancer Epidemiology and Prevention, May 2017, Vol. 2, No. 1:3, pgs. 1-6, IDS 05/09/2024).
With regard to claims 1 and 36, Stewart et al teaches a method of treating cancer with a peptide [0029]. Stewart et al further teaches the peptide inhibits calcium channel activity of TRPV6 [0008]. Stewart et al further teaches the TRPV6 peptide in combination with chemotherapeutics [0008].
Stewart et al does not specifically teach a TRPV6 inhibitor in combination with an antagonist of an inhibitory immune checkpoint molecule. However, this deficiency is made up in the teachings of Ruggero et al.
With regard to claims 1 and 36, Ruggero et al teaches of elevated TRPV6 in cancer [Left column, pg. 3]. Ruggero et al further teaches the treatment combination of calcium channel inhibitors and monoclonal antibodies PD-1 or PD-L1 [5th paragraph, Right column, pg. 3].
One of ordinary skill, before the effective filing date, would have been motivated to combine Stewart’s method of treating cancer comprising administering a TRPV6 inhibitor, with Ruggero’s method of treating cancer comprising administering a calcium channel inhibitor and an immune checkpoint inhibitor. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Stewart and Ruggero’s methods for a method of treating cancer comprising administering a TRVP6 inhibitor and an antagonist if an inhibitory immune checkpoint molecule, because Stewart and Ruggero both teach using a calcium channel inhibitor with another therapeutic to treat cancer. Furthermore, Stewart teaches the calcium channel inhibitor is a TRVP6 inhibitor and Ruggero teaches the calcium channel inhibitor is administered with an immune checkpoint inhibitor.
With regard to claim 2, Stewart et al teaches a method of treating cancer with a peptide [0029].
With regard to claims 3 and 5, Stewart et al teaches the TRPV6 inhibitor peptide with SEQ ID NO: 1. A comparison of instant SEQ ID NO: 2 and SEQ ID NO: 1 of Stewart et al is shown below.
Instant claim SEQ ID NO: 2 and Stewart et al SEQ ID NO: 1.
Query Match 100.0%; Score 70; DB 15; Length 13;
Best Local Similarity 100.0%;
Matches 13; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 KEFLHPSKVDLPR 13
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Db 1 KEFLHPSKVDLPR 13
With regards to claim 6, Stewart et al teaches the TRPV6 inhibitor peptide in combination with chemotherapeutics [0008]. Stewart et al further teaches them conjugated together [0064].
With regards to claims 10-11, Ruggero et al teaches the treatment including monoclonal antibodies against programmed death 1 (PD-1) receptor [5th paragraph, Right column, pg. 3].
With regards to claim 32, Stewart et al teaches the therapies are administered separately [0079].
With regards to claim 33, One of ordinary skill in the art would have found it obvious to optimize the administration of treatments together as part of the same composition.
With regard to the treatments administered together, being administered together is a parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal administration of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of administration of therapies would have been obvious at the time of applicant's invention.
With regards to claim 34, Stewart et al teaches the cancer over-expresses TRPV6 [0029].
With regards to claim 35, Stewart et al teaches the cancer is prostate cancer [0029].
With regards to claim 68, Stewart et al teaches the compounds in a kit [0079].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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