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 .
Election/Restrictions
Applicant’s election of Group I, (drawn to a hydroxycarboxylic acid of the formula I), in the reply filed on 03/24/2026 is acknowledged. 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)).
Claims 1-12 are pending of which claims 4, 7 and 9-12 (Group II-IV) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Pending claims 1-3, 5-6, and 8 have been examined on the merits.
Claim Rejections - 35 USC § 103
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-3, 5-6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Pillaiyar et al., ACS Omega. 2018 Mar 31;3(3):3365-3383, Chitalia et al., US 10,478,464, Kanwar et al., World J. Gastr. Pathophysiol. 2012; 3(1): 1-9, Jochems et al., Exp Biol Med (Maywood). 2011 May 1;236(5):567-79.
Regarding claim 1, Pillaiyar (abstract) teaches “GPR84, a Gi protein-coupled receptor that is activated by medium-chain (hydroxy)fatty acids, appears to play an important role in inflammation, immunity, and cancer.” Pillaiyar (page 3374; page 3365) discloses GPR84 agonists such as 3-hydroxydodecanoic acid, might be useful for the treatment of cancer by activating the immune response (immuno-oncology).
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Pillaiyar, however, does not explicitly teach colorectal cancer.
Chitalia (col. 1-3; col. 33, Example 12) teaches methods for the treatment or prevention of cancer using 8-HHA, a hydroxycarboxylic acid, and the cancer is selected from leukemia, lung cancer, liver cancer, or colon cancer. Given that colon cancer falls within the scope of colorectal cancer, a person of ordinary skill in the art (POSITA) would recognize that a method of treating colon cancer inherently includes a method of treating colorectal cancer. This is supported by Chitalia (col. 33, Example 12) disclosing 8-HHA is effective against colorectal cancer cell line. Chitalia (col. 9, line 50-54) further discloses that 8-HHA composition comprising an effective amount of a compounds herein, or a pharmaceutically acceptable salt, solvate, hydrate, polymorph or prodrug, and an acceptable carrier. Therefore, a POSITA would have been motivated to modify Pillaiyar’s teachings in view of Chitalia to encompass a method of treating colorectal cancer with 3-hydroxydodecanoic acid with an effective amount, as the combined prior art discloses that hydroxycarboxylic acid derivatives exhibit anticancer activity, including activity against colorectal cancer.
The combined teachings of Chitalia and Pillaiya do not explicitly teach recurrence of cancer.
Kanwar (page 1-2), however, teaches that recurrence of colorectal cancer remains a major clinical problem, with recurrence rates reaching 40-60% following failure of conventional treatment, and stem/stem-like cells (CSCs) are associated with chemoresistance, relapse, and metastasis. Therefore, a POSITA would have been motivated to administer 3-hydroxydodecanoic acid as part of treatment regimen against recurrence of colorectal cancer, because of failure with conventional treatment, thus new treatment regimen is necessary. Therefore, the combined teachings of Chitalia and Pillaiya would provide motivation to a POSITA with reasonable expectation of success of the therapeutic benefit of 3-hydroxydodecanoic acid against recurrence colorectal cancer.
Regarding claims 2-3, while Pillaiya does not explicitly teach stereoisomers, it would have been obvious that compounds with chiral centers inherently exist in multiple stereoisomeric forms, including the enantiomeric forms claimed, within the racemate depicted by Pillaiya. See MPEP 2112 and 2144.09. For example, Pillaiya (page 3368, Table 1) discloses the compound as: (R,S)-3-hydroxydodecanoic acid.
Regarding claim 5, and as applied to claim 1 above, Chitalia (col. 10, line 9-20) teaches the following:
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Given that intravenous, parenteral and topical formulation are standard routes of administration, a POSITA would have had a reason to combine the teachings of Chitalia and Pillaiya to formulate 3-hydroxydodecanoic acid compound into such dosage form with a reasonable expectation of success because these routes are well known in the art.
Regarding claim 6, as applied to claim 1 above, Jochems (page 1-5; page 21-26, Table 1) recites that colorectal tumor characterizes by decreased immune infiltrate, particularly decreased or absent tumor-infiltrating CD8+ T cells, exhibit poorer prognosis and altered therapeutic responsiveness. Jochems (page 1-5; page 21-26, Table 1) also recites that increased infiltration of CD8+ T cells correlate with improved survival and therapeutic outcomes and emphasizes the importance of enhancing immune response in tumors having deficient immune infiltration. Therefore, a POSITA would have been motivated to administer 3-hydroxydodecanoic acid compound to increase or induce an immune response in colorectal tumors characterized by reduced or absent tumor-infiltrating immune cells, including reduced CD8+ T-cell infiltration, as hydroxycarboxylic acid compounds are useful for the treatment of cancer by activating the immune response (Pillaiyar, page 3374; page 3365). The claimed invention, therefore represents a predictable application of known immune-modulating hydroxycarboxylic acid compounds to known immunologically deficient colorectal tumors.
Regarding claim 8, and as applied to claim 1 above, given that Pillaiyar discloses hydroxycarboxylic compounds against cancer and do not require co-administration of checkpoint inhibitors, chemotherapeutic agents, or other antineoplastic drugs to achieve the disclosed effects; thus, it would have been obvious to a POSITA to administer 3-hydroxydodecanoic acid as monotherapy, i.e., without concurrent, previous, or subsequent administration of additional antineoplastic agents. Therefore, it would have been obvious to modify Pillaiyar’s teachings in view of Chitalia and administer 3-hydroxydodecanoic as a monotherapy against cancer, because such treatment approach is already disclosed in the art. Thus, the instant invention represents a modification of the combined prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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