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 .
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.
Current Status of 18/852,916
This Office Action is responsive to the amended claims received 2 June 2025.
Claims 1-2, 4-9, 12, 16-19, 24, 38, 40-42, 44, and 46 are currently pending.
Priority
Applicant’s claim for the benefit of the prior-filed patent applications PCT/US2023/065156 (filed 30 March 2023) and 63/325,456 (30 March 2022) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) received on 19 November 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application for the following reasons: Figures 1-7 are labeled with some variation of “FIG. 1 A-J”, while also being labeled with Figure 1, for example. This redundant naming is not correct. Labelling any of the drawings with something of the form “FIG. 1 A-J” is also incorrect by itself, because 37 CFR requires each view to be separately labeled. The Examiner would suggest Applicant relabel each view as FIG. 1A, FIG. 1B, and so on. Figures 1-7, 9, 12, 18-20, and 22 each contain text that is too small and/or low-resolution to be legible.
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pages 40, 53, 70, and 74. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. References to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01(VII).
The disclosure is objected to because of the following informalities: The description of figures 1, 4-5, and 20, within the instant specification, each mention color being present in the instant drawings. However, there is currently no color present in the instant drawings. Appropriate correction is required.
Claim Objections
Claim 17 is objected to because of the following informalities: Claim 17 is missing the article “an” before “immune checkpoint inhibitor”. Appropriate correction is required.
Claims 40 is objected to because of the following informalities: Claim 40 should include the word “further” before the word “comprises” to increase readability 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 12, 18-19, and 40-42 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.
Claims 12 and 18-19 each recite a list, but the list is missing a conjunction. The reader does not know if the cancer, protein, or drug is all of the items in the list or one of them. This renders claims 12 and 18-19 indefinite. Applicant may choose the insert one of the words “or” or “and” before the final item in the list.
Claims 40-42 each recite “the composition”, but it is not clear what composition this refers to, as it was not introduced earlier. This renders claims 40-42 indefinite. Applicant may choose to amend the phrase “administering a trans-vaccenic acid…” of claim 38 as follows “administering a composition comprising a trans-vaccenic acid…”.
Claim 41 recites “CRIPSR”. This appears to be a misspelling of the term “CRISPR” discussed within the specification, but because the reader would not be sure what is being claimed, this renders claim 41 indefinite.
Claim 42 requires that the composition of claim 38 “wherein the composition comprises a small molecule inhibitor of GPR43 activity”. It is unclear to the reader whether the TVA or TVA derivative of claim 38 satisfies this requirement. This renders claim 42 indefinite. Applicant may choose to amend the claim to recite “wherein the composition further comprises”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-9, 12, 24, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
BAUMAN (Cited by Applicant in IDS of 19 November 2025; US 2005/0004218 A1, Publication Date 6 January 2005).
BAUMAN teaches trans-vaccenic acid (TVA) to be a potent anti-cancer agent (paragraph [0006]). BAUMAN teaches that an exemplary composition that includes TVA is ice cream (paragraph [0010]). BAUMAN also teaches that TVA may be included in a tablet composition (paragraph [0011]). BAUMAN teaches that the TVA compositions therein may be used to treat breast cancer (paragraph [0012]).
BAUMAN teaches that the compositions therein may be used in combination with conventional cancer chemotherapies, and treatment with TVA can increase the sensitivity of the tumor to the conventional chemotherapy (paragraph [0032]). BAUMAN teaches a list of known chemotherapeutic compounds in paragraph [0034], which includes gemcitabine.
Regarding claims 2 and 38: The outcomes within instant claims 2 and 38 are solely the result of administering the compound of claim 1 or claim 38 to the subject. There are no positive steps recited therein that would alter these outcomes unrelated to administering the compound of instant claim 1 or instant claim 38 to the subject. Therefore, because the method of administering the compound of instant claim 1 or claim 38 to the subject has been found to be anticipated, these direct outcomes must also be anticipated, unless Applicant would like to argue that only a properly enabled subset of the compounds of claim 1 or claim 38 would provide the effects of claim 2 or claim 38.
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.
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 1-2, 4-9, 12, 24, 38, 42, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over:
BAUMAN (Cited by Applicant in IDS of 19 November 2025; US 2005/0004218 A1, Publication Date 6 January 2005)
in view of:
SANIERE (WO 2012/098033 A1, International Publication Date 26 July 2012).
Teachings of BAUMAN are described above. BAUMAN does not teach TVA or a derivative thereof in combination with either of the small molecules of instant claims 44 or 46. However, BAUMAN does suggest combining the compositions therein with other anti-cancer drugs.
SANIERE teaches that the compounds therein are inhibitors and antagonists of GPR43 (also known as FFAR2) (paragraphs [0001] and [0072]). SANIERE teaches the compound shown in instant claim 44 as compound 191 on page 164 therein. Claim 17 of SANIERE teaches that the compounds therein are useful for the treatment of proliferative diseases. SANIERE specifies that breast cancer is a type of proliferative disease (paragraphs [0057]-[0058]).
It would have been obvious to one of ordinary skill in the art, before the instant effective filing date, to combine any of the compounds taught by SANIERE to treat breast cancer with the TVA tablet composition taught by BAUMAN to treat breast cancer, for the purpose of increasing the anti-breast cancer efficacy of the treatment. The artisan would have expected success in this combination, because both SANIERE and BAUMAN teach that the compounds therein are useful to treat breast cancer.
This is an example of combining equivalent therapeutic agents known to be useful for the same purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06.
Claims 1-2, 4-9, 12, 24, 38, 42, 44, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over:
BAUMAN (Cited by Applicant in IDS of 19 November 2025; US 2005/0004218 A1, Publication Date 6 January 2005)
in view of:
SANIERE (WO 2012/098033 A1, International Publication Date 26 July 2012)
and in view of:
HANSEN (Hansen, A.H.; Sergeev, E.; Pandey, S.K.; et al. “Development and Characterization of a Fluorescent Tracer for the Free Fatty Acid Receptor 2 (FFA2/GPR43)” J. Med. Chem. 2017, 60, 5638−5645).
Teachings of BAUMAN and SANIERE are described above. Neither BAUMAN nor SANIERE teach the compound shown in instant claim 46. However, BAUMAN does suggest combining the compositions therein with other anti-cancer drugs.
SANIERE teaches that the compounds therein are inhibitors and antagonists of GPR43 (also known as FFAR2) (paragraphs [0001] and [0072]). SANIERE teaches the compound shown in instant claim 44 as compound 191 on page 164 therein. SANIERE teaches that the compounds therein are useful for the treatment of proliferative diseases (claim 17), and specifies that breast cancer is a type of proliferative disease (paragraphs [0057]-[0058]).
HANSEN teaches that GPR43 is also referred to as FFA2 therein (introduction section). HANSEN teaches the compounds shown below as their selected FFA2 (GPR43) antagonists in Table 4. Compound 1 below is identical in structure to compound 191 of SANIERE and the compound of instant claim 44, although compound 1 of HANSEN is drawn as the racemate. HANSEN teaches that compounds 1 and 8 have high affinity for FFA2 (GPR43), but compound 9 does not. Compound 8 of HANSEN is identical to the compound shown in instant claim 46.
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It would have been obvious to one of ordinary skill in the art, before the instant effective filing date, to use a GPR43 antagonist to treat breast cancer (as taught by SANIERE) with either of the two high affinity FFA2 (GPR43) antagonists taught by HANSEN, for the purpose of treating breast cancer. The artisan would have expected success in the combination of SANIERE and HANSEN because both SANIERE requires a GPR43 antagonist to treat breast cancer and HANSEN provides two high-affinity GPR43 antagonists (one of which is also discussed in SANIERE). It also would have been obvious to combine these therapies with another known anti-breast-cancer compound, including TVA taught by BAUMAN. The artisan would have expected success combining the GPR43 antagonist breast cancer treatment with the TVA treatment of BAUMAN, because they both teach compounds capable of treating breast cancer.
This is an example of combining equivalent therapeutic agents known to be useful for the same purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06.
Claims 1-2, 4-9, 12, 16-19, 24, 38, 42, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over:
BAUMAN (Cited by Applicant in IDS of 19 November 2025; US 2005/0004218 A1, Publication Date 6 January 2005)
in view of:
VOORWERK (Voorwerk, L; Slagter, M.; Horlings, H.M.; et al. “Immune induction strategies in metastatic triple-negative breast cancer to enhance the sensitivity to PD-1 blockade: the TONIC trial” Nature Medicine | 920 VOL 25 | JUNE 2019 | 920–928).
Teachings of BAUMAN are described above. BAUMAN does not teach TVA or a derivative thereof in combination with an immunotherapeutic. However, BAUMAN does suggest combining the compositions therein with other anti-cancer drugs.
VOORWERK generally teaches the results of a clinical trial treating triple negative breast cancer with nivolumab (abstract). VOORWERK teaches that treatment of triple negative breast cancer patients with nivolumab resulted in an objective response rate of 20 %, which is stated to be higher than other studies in the same patient population (3rd paragraph of page 925).
It would have been obvious to one of ordinary skill in the art, before the instant effective filing date, to combine the nivolumab therapy taught by VOORWERK to treat breast cancer with the TVA composition taught by BAUMAN to treat breast cancer, for the purpose of increasing the anti-breast cancer efficacy of the treatment. The artisan would have expected success in this combination, because both VOORWERK and BAUMAN teach that the compounds therein are useful to treat breast cancer.
This is an example of combining equivalent therapeutic agents known to be useful for the same purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06.
Conclusion
No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANDREW D KOSAR can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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