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
2. Applicant’s election without traverse of Group II, and species of composition A, in the replies filed on August 18, 2025 and January 15, 2026 is acknowledged.
3. Examination followed guidelines provided by MPEP 803.02. The elected species appeared to be obvious over the prior art. Additionally, nonelected species were anticipated by the prior art. Therefore, the Markush claims were rejected and claims to nonelected species were withdrawn from further consideration. The claims were searched to the extent of the elected species and the nonelected species shown below.
4. Claims 53, 54, 56, 81, 86, 94 and 95 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter. Election was made without traverse in the replies filed on August 18, 2025 and January 15, 2026.
Status of Claims
5. Claims 1, 2, 4, 29, 34, 40, 45, 53, 54, 56, 81, 86, 94 and 95 are pending. Claims 1, 2, 4, 29, 34, 40, 45 are elected. Claims 53, 54, 56, 81, 86, 94 and 95 are withdrawn. Claim 1 is independent.
Information Disclosure Statement
6. The information disclosure statement (IDS) submitted on August 18, 2025 was in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS was considered. A signed copy of form 1449 is enclosed herewith.
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.
7. Claims 1, 2, 4, 29, 34, 40 and 45 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed to methods of treating or preventing a liver disease by administering a composition comprising a mixture of a first and a second monounsaturated fatty acid. Applicants describe embodiments of treatment of fatty liver disease using a composition A, which is the mixture of 20% C16:1 and 70% C18:1. The embodiment does not provide sufficient number of species within the genus of a composition comprising a mixture of a first and a second monounsaturated fatty acid. C16:1 and C18:1 is only one species within the generic claim. The skilled artisan would not recognize that Applicants have possession of the genus given the one specific embodiment, which furthermore is addressed to the method of treating one specific disease. The state of the art in the treatment of liver disease using fatty acids is not predictable in that the possession of one species would indicate possession of the entire genus. For example, the reference of Hodgon et al. shows this unpredictability. Hodgon teaches examples where fatty acids lead to disease in the liver. The skilled artisan cannot determine which combinations of fatty acids would lead to disease versus treatment. Thus the prior art suggests that there is a lack of structure function correlation since some structures lead to treatment and some structures lead to disease. Moreover, there is no additional evidence as the field is relatively nascent, and the evidence that exists suggests that the composition and amount of dietary fat may lead to liver fat content which in turn leads to liver diseases. For these reasons, it is determined that the presently claimed genus is not sufficiently described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention
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.
8. Claims 29 recites the limitations “the saturated fatty acid” or “the polyunsaturated fatty acid.” There is insufficient antecedent basis for this limitation in the claim. The limitations in claim 29 sections (a)-(f) are referred to as and/or. The limitations in sections (b)-(e) refer to “the saturated fatty acid” or “the polyunsaturated fatty acid”, however, independent claim 1 does not recite “a saturated fatty acid” or “a polyunsaturated fatty acid.”
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.
9. Claim(s) 1, 2, 4, 29, 34, 40 and 45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5,198,250. The reference has a publication date of March 30, 1993 which antedates the present claims having a filing date of August 21, 2020 and priority claim to provisional application dated August 21, 2019.
The reference teaches compositions containing monounsaturated fatty acids and the administration to improve the metabolic processing of lipids. See abstract. The improvement is disclosed prevent the formation of fat globules which may produce hepatocyte injury or dysfunction and the condition of fatty liver. See column 4, lines 55-68. The reference discloses that C16:1 is useful for improving lipid metabolism. Column 6. The reference teaches compositions that comprise monounsaturated fatty acids (MUFAs) for treatment, wherein the MUFAs specifically mentioned are palmitoleic (C16:1), myristoleic (C14:1), lauroleic (C12:1), oleic (C18:1), and mixtures – columns 6-0. The reference further teaches benefit to lower melting points of fatty acids. The reference also teaches the mixing of short chain MUFAs to decrease parameters such as lower melting point. See for example, Table II, column 14 wherein C16:1 and C18:1 are added for formulating dietary compositions for administration. Present claim 4. In the specific embodiment, C16:1 is added at 21.76% MW and C18:1 is added at 43/47% MW. Based on melting points of C16:1 of -0.5 and C18:1 of 13 (see references of Palmitoleic and Oleic), and as evidenced by the present specification, the melting point of a mixture of palmitoleic and oleic at the cited molar amounts will be within the claimed limitation of -1.7-10.7 degrees Celsius (claim 1), and 3-9 or 7-9 degrees Celsius (claim 2). Lastly, based on the molecular weights of the fatty acids in Table II of the reference, the weight percent of saturated fatty acid is 14 and of C16:1 monounsaturated is 20. This corresponds to the limitations in claim 29 and 34. Lastly, regarding claim 45, the reference teaches a composition wherein the composition further comprises one or more carrier fatty acids, column 14 lines 54-68.
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.
10. Claim(s) 1, 2, 4, 29, 34, 40 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5,198,250 as applied to claims 1, 2, 4, 29, 34, 40 and 45 above.
Determining the scope and contents of the prior art
US 5,198,250 teaches compositions containing monounsaturated fatty acids and the administration to improve the metabolic processing of lipids. See abstract. The improvement is disclosed prevent the formation of fat globules which may produce hepatocyte injury or dysfunction and the condition of fatty liver. See column 4, lines 55-68. The reference discloses that C16:1 is useful for improving lipid metabolism. Column 6. The reference teaches compositions that comprise monounsaturated fatty acids (MUFAs) for treatment, wherein the MUFAs specifically mentioned are pamitoleic (C16:1), myristoleic (C14:1), lauroleic (C12:1), oleic (C18:1), and mixtures – columns 6-0. The reference further teaches benefit to lower melting points of fatty acids. The reference also teaches the mixing of short chain MUFAs to decrease parameters such as lower melting point. See for example, Table II, column 14 wherein C16:1 and C18:1 are added for formulating dietary compositions for administration. Present claim 4. In the specific embodiment, C16:1 is added at 21.76% MW and C18:1 is added at 43/47% MW. Based on melting points of C16:1 of -0.5 and C18:1 of 13 (see references of Palmitoleic and Oleic), and as evidenced by the present specification, the melting point of a mixture of palmitoleic and oleic at the cited molar amounts will be within the claimed limitation of -1.7-10.7 degrees Celsius (claim 1), and 3-9 or 7-9 degrees Celsius (claim 2). Lastly, based on the molecular weights of the fatty acids in Table II of the reference, the weight percent of saturated fatty acid is 14 and of C16:1 monounsaturated is 20. This corresponds to the limitations in claim 29 and 34. Lastly, regarding claim 45, the reference teaches a composition wherein the composition further comprises one or more carrier fatty acids, column 14 lines 54-68.
Ascertaining the differences between the prior art and the claims at issue
US 5,198,250 does not teach the administration of a specific composition as in Applicant’s elected species, wherein C16:1, C18:1, C16:0 and C18:2 are provided in specific amounts.
Resolving the level of ordinary skill in the pertinent art - considering objective evidence present in the application indicating obviousness
One of ordinary skill in the art has the teaching and suggestion in the reference to prepare pharmaceutical compositions as claimed in the elected species. The reference teaches monounsaturated fatty acids C16:1 and C18:1 in combination with C16:0 and C18:2. The reference also teaches that decreasing the melting point in the mixture of amino acids is beneficial for treatment. MPEP 2122.05 states that differences in concentration or temperature will not support the patentability as it is not inventive to discover optimum or workable ranges by routine experimentation. The skilled artisan has the motivation of prepare compositions of varying concentrations/amounts of the fatty acids with a reasonable expectation of success. Therefore, Applicant’s elected species is found to be prima facie obvious over the prior art.
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621