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 .
Status of Claims
Claims 1 and 5-11 are pending.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/JP2020/029254, filed 7/30/2020; and further claims priority to FOR application number JP2019-140770, filed 7/31/2019. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
All references from IDS(s) received 01/28/2022, 8/2/2024, and 4/4/2025 have been considered unless marked with a strikethrough.
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not fully persuasive.
In a non-final dated 05/23/2025, Claims 1-11 were examined upon their merits.
In a non-final dated 07/22/2025, Claims 1-11 were rejected under 35 U.S.C. 101, 102, and double patenting rejections. In response, Applicant amended claim 1 to recite:
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The Applicant also cancelled claims 2-4 and 12-14, so the rejection/withdrawal of these claims is moot and withdrawn.
With respect to the 101 rejection, the Applicant argues that the claimed composition is not a mere mixture or simple isolation of a compound found in nature. The Applicant points out that as discussed in the Specification, the instantly claimed triglyceride is highly purified and intentionally modified composition obtained through a controlled, human-intervened process. The Examiner argues that although this may be true, there are no quantities or processes listed in the claims to reflect this. As the claims stand, they recite a compound found in nature and fall under intended use. Therefore, the 101 rejection is maintained.
With respect to the 102 rejection, the Applicant argues that the primary reference provided by the Examiner (“Sadai”) does not teach a composition with a triglyceride mixture where two of the fatty acids are pentadecanoic acid and the other is myristic acid or palmitic acid. The Examiner agrees that Sadai does not teach any explicit examples where the triglyceride contains myristic acid, for example. However, Sadai teaches that the triglyceride may have two odd chain length fatty acids and may have one even chain length fatty acid or it can have all odd chain length fatty acids. Sadai also fails to explicitly teach a composition containing three different active triglycerides. However, Kunimitsu teaches a triglyceride composition containing multiple triglycerides that can be used for improving skin health. Therefore, it would be obvious to extract the composition of Sadai and use three of the different active triglycerides in the mixture, as motivated by Kunimitsu. Therefore, although Sadai would no longer anticipate instant claim 1, it would be considered obvious to a person skilled in the art. See new 103 rejection below.
With respect to the double patenting rejection, the Applicant did not provide an argument other than that they will provide a terminal disclaimer when the rest of the rejections are withdrawn. Therefore, the double patenting rejection is maintained.
MAINTAINED/NEW REJECTIONS
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 5-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claim(s) recite(s) a triglyceride containing with either all pentadecanoic acid or some pentadecanoic acid and a palmitic acid side chain. Batrakov et al. (Bioorganicheskaya Khimiya, Characterization of the molecular species of natural lipids by metastable ion mass spectra. I. Triglycerides, 1978, 4, 9, 1220-1231; cited in IDS filed 1/28/2022; “Batrakov”) teaches that these are naturally occurring triglycerides (see photos below for examples of what is taught as naturally occurring triglycerides where two of the side chains are pentadecanoic acid and one is palmitic acid, as required by the elected specie, or all are pentadecanoic acid).
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The Examiner has followed the guidance set forth in MPEP 2106 and has concluded that the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter.
Eligibility Step 1: The Four Categories of Statutory Subject Matter
Step 1 asks if the claim is to a process, machine, manufacture or composition of matter.
The claims recite a triglyceride containing with either all pentadecanoic acid or some pentadecanoic acid and a palmitic acid side chain. Therefore, the answer to the question of Step 1 for claims 1-11 is Yes, because the claims are considered directed to a composition of matter, which is eligible subject matter.
Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception
Prong One asks if the claim recites a natural phenomenon. In the instant case, composition of the instant claims comprises a triglyceride containing with either all pentadecanoic acid or some pentadecanoic acid and a palmitic acid side chain, which occurs naturally, as taught by Batrakov. The characteristics of this composition are not markedly different from the naturally occurring counterpart in its natural state within the body. Therefore, Yes, Claims 1-11 are directed to a natural product (i.e., a law of nature/a natural phenomenon).
Prong Two asks if the claim recites additional elements that integrate the judicial exception into a practical application. In the instant case, the judicial exception is not integrated into a practical application because the claims merely recite the composition and its constituents without reciting any additional steps or elements that rely on or use the compound for any practical purpose.
Eligibility Step 2B: Whether a Claim Amounts to Significantly More
Step 2B asks if claims recite additional elements that amount to significantly more than the judicial exception. In the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because there are no “additional elements” required by the present claims since they are directed only to the naturally occurring substance itself.
Therefore, the claimed composition is not deemed to be markedly different from what exists in nature in terms of structural and/or functional differences. In other words, the claims do not set forth a marked difference in terms of structural and/or or functional differences (properties and/or characteristics) as compared to the naturally-occurring counterpart(s) (see, e.g., Diamond v. Chakrabarty, 447 U.S. 303(1980)). Please also note that modifying the concentration of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)).
Therefore, claims 1 and 5-11 are not directed to patent eligible subject matter.
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 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 and 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Sadai, M. et al. (JPS601111A; cited in IDS filed 1/28/2022; “Sadai”) in further view of Kunimitsu, K. et al. (JP2016089025A; cited in IDS filed 1/28/2022; “Kunimitsu”).
Sadai teaches a cosmetic composition containing triglyceride fatty acids, including palmitic and pentadecanoic acid chains.
Sadai teaches a triglyceride where at least two of the side chains have an odd carbon chain length, such as pentadecanoic acid (C15), and one has an even chain length, such as palmitic acid (C16).
Sadai does not teach a triglyceride containing a side chain of myristic acid, however teaches generally that one of the side chains can be of even carbon chain length. Since myristic acid is C14, it would be considered obvious to a person skilled in the art that myristic acid can constitute one of the fatty acid side chains of the triglyceride.
Sadai does not teach the cosmetic composition to explicitly be used for collagen production, however Sadai does teach the cosmetic for use in “protects skin from various skin diseases such as cracks, chapped skin, rough skin, and chilblains caused by a decline in the skin's ability to retain moisture and poor blood circulation, as well as skin aging phenomena such as skin sagging, wrinkles, and loss of luster,” as required by instant claims 5-7. Sadai further teaches “it effectively enhances the activation of the skin, such as improving skin function and increasing skin blood flow, thereby promoting prevention and normalization.” This would align with the function of collagen production.
Sadai does not explicitly teach the composition as a food or beverage, as required by instant claims 8-9. However, this rejection is based on the interpretation that the preamble is intended use language.
Here the composition of the art is capable of performing the intended use. During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein. See MPEP 2111.02.
With respect to independent claim 10 and dependent claim 11, the preamble contains product by process language. Therefore, the preamble is interpreted as intended use and given no weight. Further, to satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See MPEP 2111.02(II).
Sadai also fails to explicitly teach a composition containing three different active triglycerides. However, Kunimitsu teaches a triglyceride composition containing multiple triglycerides that can be used for improving skin health. Therefore, it would be obvious to extract the composition of Sadai and use three of the different active triglycerides in the mixture, as motivated by Kunimitsu.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the triglyceride of Sadai and substitute one of the side chains for myristic acid because Sadai teaches that one of the side chains can be of even carbon chain length, and since myristic acid is C14, it would be considered obvious to a person skilled in the art that myristic acid can constitute one of the fatty acid side chains of the triglyceride.
Therefore, claims 1 and 5-11 would have been obvious to a person skilled in the art at the time.
Double Patenting
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 5-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 17/779,904. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of the claims require the same compound genus, the only difference is the preamble language. Since the claims are product claims, the preamble is interpreted as intended use and given no weight. Further, to satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See MPEP 2111.02(II).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1 and 5-11 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621