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 .1
Status of Claims
Claims 1-19 are pending. Claims 1-8 are examined. Claims 9-19 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of the species, nonalcoholic fatty liver disease in the reply filed on 17 August 2026 is acknowledged.
Upon further search and consideration, the examined species has been expanded to include non-alcoholic steatohepatitis from claim 4. Claim 4 has been rejoined and examined.
Claims 9-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 17 August 2026.
The pending, examined claims are directed solely to 2-ethylpentadecanoic acid, a variation of pentadecanoic acid, and homolog of 2-methylpentadecanoic acid from parent divisional application, 16/932,508 issued as US 11951088.
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CAS Registry Number: 69868-06-02
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 07/27/2026, 06/26/2026, 02/27/2026, 11/17/2025, 07/23/2025, and 04/15/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 5-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for various types of liver disease (such as nonalcoholic fatty liver disease and nonalcoholic steatohepatitis) does not reasonably provide enablement the full scope of liver diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. The specification does not enable any person having ordinary skilled in the art (PHOSITA) to which it pertains, or with which it is most nearly connected, to practice the invention.
Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set eight forth factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
The predictability or unpredictability of the art: The instant claimed invention is highly unpredictable since a person having ordinary skill in the art (PHOSITA) recognizes the unpredictability in treating all liver diseases inclusive of liver cancer.
Cigliano et al.3 teaches the uncertainty in treating liver cancer with fatty acids. It is noted 2-ethylenepentanoic acid is a fatty acid.
The therapeutic targeting of fatty acid metabolism in primary liver cancer presents a notable paradox. Despite a strong mechanistic understanding, clinical translation has stalled, revealing flaws in current drug development strategies. Metabolic adaptation, now recognized as a hallmark of cancer, allows malignant cells to survive in hostile environments, with lipid dysregulation playing a complex role in cancer progression. Lipids serve not only as energy sources but also as essential components of cell membranes, intracellular signaling molecules, and modulators of the tumor microenvironment and immune response. See Conclusions section, page 22 of 24.
Accordingly, the unpredictability in the art is Wands factor against enablement of the claims.
The breadth of the claims :The instant claims are very broad since the claims read on treatment of any liver disease, including the broad category of any liver cancer. The broad scope is a Wands factors weighing against enablement the rejected claim(s).
The amount of direction or guidance presented, and the presence or absence of working examples: It has been established that “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” In re Fisher, 427 F.2d 833, 839 166 USPQ 18, 24 (CCPA 1970).
There is no working example (other than Comparative Examples 1 (paragraph 219) and 2 (paragraph 223), where rabbit in vivo models were fed a high fat diet and treated with fatty acids), either in vivo or in vitro to enable the treatment of any liver disease, such as liver cancer.
The lack of working examples is a Wands factor against enablement of the full scope of the invention.
In summary, per the Wands factors detailed above, the claims are not enabled for the full scope as claimed.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/111843, aka Venn-Watson WO ‘843, published July 14, 2016. Venn-Watson is cited on the IDS dated April 15, 2025, as For. Ref. No. 134.
Claims 1-8 are directed to the treatment of liver diseases, such as fatty liver diseases with 2-ethylpentadecanoic acid, (a fatty acid with 17 total carbons),
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Regarding claims 1-2, Venn-Watson WO ‘843 teaches the treatment of the claimed types of liver diseases, nonalcoholic steatohepatitis and nonalcoholic fatty liver disease as follows with homolog of the claimed fatty acid, heptadecanoic acid, which contains 17 carbon atoms.
Regarding claims 1-2, Venn-Watson WO ‘843 discloses a method of treatment or prophylaxis metabolic syndrome, and associated disease, fatty liver, see claim 15. In particular WO ‘843 teaches treatment of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. See paragraph 104.
Venn-Watson WO ‘843 discloses and exemplifies the fatty acid heptadecanoic acid (a fatty acid with 17 total carbons),
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to treat the claimed conditions. See paragraphs 104 and 116. More specifically, Example 1 of Venn-Watson WO ‘843 discloses the intake of heptadecanoic acid (17:0) in a dolphin population known to develop metabolic syndrome, starting at paragraph 157, but also see paragraph 160 and Table 3.
While Venn-Watson WO ‘843 teaches treating the same diseases as claims 1-8 with a 17 carbon fatty acid, such as heptadecanoic acid, it does not teach the claimed species 17 carbon fatty acid species, 2-ethylpentadecanoic acid.
To address this, the claimed fatty acid and taught fatty acid of Venn-Watson, heptadecanoic acid, both contain 17 carbons. See also paragraph 75.4
While not necessarily teaching the claimed 17 carbon fatty acid, 2-ethylpentadecanoic acid, prior to the filing of the instant application, a PHOSITA following the teachings of Venn-Watson would have found it prima facie obvious to arrive at the 17 carbon containing 2-ethylpentadecanoic acid, as Venn-Watson also teaches the treatment of the same conditions, non-alcoholic fatty liver disease and steatohepatitis with another 17 carbon fatty acid, heptadecanoic acid. See paragraphs 75, 104, 116, 157, 160, and claims 1-21 of Venn-Watson. The rationale to do so is noted by the MPEP 2144.09(I).
Per MPEP 2144.09(I)
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c).
While heptadecanoic acid and the claimed species, 2-ethylpentadecanoic acid differ by virtue of arrangement of the 17 carbons of each, the MPEP allows for a prima facie case to be established where chemical structures are similar with similar utilities (i.e. treatment of the same diseases).
The rationale to support the prima facie case of obviousness is where Venn-Watson WO ‘843 teaches a similar 17 carbon fatty acid for treatment of the similar/same conditions (metabolic syndrome, non-alcoholic steatohepatitis, etc.).
Regarding claims 3-4, Venn-Watson WO ‘843 teaches treatment of non-alcoholic fatty liver disease and steatohepatitis, see paragraphs 104 and 116.
Regarding claims 5 and 6, Venn-Watson WO ‘843 teaches a unit dosage form that comprises from 0.01 mg to 10000 mg of the one or more odd chain fatty acids, see claim 17.
Regarding claims 7 and 8, Venn-Weston WO ‘483 teaches foodstuffs and comestibles. See paragraph 102.
Non-Statutory Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-8 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over the following reference patents:
claim 1 of US 9707199
claim 1 of US 9713600
claims 1-7 of US 10022347 and
claims 1-13 of US Patent 10449171 in view of WO 2016/111843, aka Venn-Watson WO ‘843, published July 14, 2016.
The contents and disclosure of claims 1-8 are discussed above and hereby incorporated herein.
The claims of US Patent 9707199 generally claims a method comprising the step of using heptadecanoic acid in a supplement to human diet at a level sufficient to treat symptoms of metabolic syndrome, wherein said supplement is selected from the group consisting of food additives, food fortifiers, beverage additives, beverage fortifiers, or pharmaceuticals, and is administered to a subject at a daily dose comprising an approximate minimum of 3 mg per lb. (or 6 mg per kg) of body weight.
The claims of US Patent 9713600 generally claims a method for treating metabolic syndrome comprising the step of administering a minimum daily dose of heptadecanoic acid to a subject suffering from metabolic syndrome, said administering step being accomplished for a period of time from three weeks to twenty-four weeks, said minimum daily dose comprising about 3 mg per lb. (or 6 mg per kg) of body weight. It is known that metabolic syndrome is known to be associated with conditions such as fatty liver disease as per Venn-Watson. See paragraph 17.
The claims of US Patent 10022347 generally claims method of treatment of type 2 diabetes, elevated fasting plasma glucose, elevated serum triglycerides, and hyperferritinemia, comprising the step of: administering to a patient in need thereof, an effective amount of one or more odd chain fatty acids or pharmaceutically acceptable salts thereof, wherein said odd chain fatty acids is selected from the group consisting of C15:0 (pentadecanoic acid) and C17:0 (heptadecanoic acid). It is known that elevated serum triglycerides are known to be associated with conditions such as fatty liver disease as per Venn-Watson. See paragraph 17.
The claims of US Patent 10449171 claims a method of treatment of metabolic syndrome, cardiovascular disease, fatty liver disease, abdominal obesity, proinflammatory state, and a prothrombotic state, comprising the step of: administering to a patient in need thereof, an effective amount of one or more odd chain fatty acids or pharmaceutically acceptable salts thereof, wherein said odd chain fatty acids is selected from the group consisting of C15:0 (pentadecanoic acid), C17:0 (heptadecanoic acid), or a mixture of C15:0 and C17:0, see claim 1 and pharmaceutical compositions per se.
With regard to the species of 2-ethylpenadecanoic acid not taught by the reference patents, a PHOSITA following the teachings of Venn-Watson would have found it prima facie obvious to arrive at 2-ethylpentadecanoic acid (a fatty acid that contains 17 carbons), as Venn-Watson also teaches the treatment of the same conditions, non-alcoholic fatty liver disease and steatohepatitis with another 17 carbon fatty acid, heptadecanoic acid. See paragraphs 75, 104, 116, 157, 160, and claims 1-21 of Venn-Watson. The rationale to support the prima facie case of obviousness is where Venn-Watson WO ‘843 teaches a 17 carbon fatty acid for treatment of the similar/same conditions (metabolic syndrome, non-alcoholic steatohepatitis, etc.) (per MPEP 2144.09(I) compounds of similar structure with similar utilities prima facie obvious).
Further, regarding claims 3-4, Venn-Watson WO ‘843 teaches treatment of non-alcoholic fatty liver disease and steatohepatitis, see paragraphs 104 and 116.
Regarding claims 5 and 6, Venn-Watson WO ‘843 teaches a unit dosage form that comprises from 0.01 mg to 10000 mg of the one or more odd chain fatty acids, see claim 17.
Regarding claims 7 and 8, Venn-Weston WO ‘483 teaches foodstuffs and comestibles. See paragraph 102.
Conclusion and Correspondence
In summary no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 CONTINUING DATA
This application is a DIV of 16/932,508 07/17/2020 PAT 11951088
16/932,508 is a DIV of 16/164,573 10/18/2018 PAT 10792266
16/164,573 has PRO 62/575,973 10/23/2017
2 Canonical SMILES O=C(O)C(CC)CCCCCCCCCCCCC
InChI InChI=1S/C17H34O2/c1-3-5-6-7-8-9-10-11-12-13-14-15-16(4-2)17(18)19/h16H,3-15H2,1-2H3,(H,18,19)
InChI Key YLHTWBSSXRGRNF-UHFFFAOYSA-N
3 Cigliano et al. Targeting Fatty Acids in Liver Cancer: Molecular Insights and Drug Approaches
Biomolecules. 2026 Feb 20;16(2):329. doi: 10.3390/biom16020329
4 Venn-Watson WO ‘843 teaches other specific odd chain fatty acids, that have from 9 carbon atoms to 31 carbon atoms (9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, or 31 carbon atoms), for example, from 15 to 21 carbon atoms (see paragraph 75) for its method of treating its taught diseases, (see paragraph 104).
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