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 .
Claim Status
Claims 1, 17-20, 24, and 27-32 are pending.
Claim 19 is currently amended and claims 27-32 are new.
Claim 2-16, 21-23, and 25-26 is canceled.
Claims 1, 17-18, and 24 are withdrawn as being directed to a non-elected method invention, the election having been made on 3/14/2023.
Claims 19-20 and 27-32 have been examined.
Priority
This application is a 371 of PCT/EP2019/025028 filed on 01/29/2019 which claims foreign priority of FRANCE 1850845 filed on 02/01/2018.
Terminal Disclaimer
The terminal disclaimer filed on 4/9/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11,001,607 has been reviewed and accepted. The terminal disclaimer has been recorded.
Withdrawn Rejection
The rejection of claims 19-21 and 25-26 under 35 U.S.C. 101 is withdrawn because the amendment to claim 19 overcomes the rejection.
The rejection of claim 22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn because claim 22 has been cancelled.
The rejection of claims 19-20 and 25-26 on the ground of nonstatutory double patenting as being unpatentable over claims 11 and 14-15 of U.S. Patent No. 11,001,607 B2 is withdrawn because applicant’s approved TD overcomes the rejection.
New Ground of Rejection
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.
Claim 29 is rejected under 35 U.S.C. 101 because the claims encompass a natural composition of flax seed oil extract together with a natural fatty excipient. The eligibility of patent subject of 101 analysis is further analyzed as follows.
Step 1. The claim is directed to a composition. comprising (i) a mixture of cyclic peptides and (ii) a natural compound of a caprylic/capric triglyceride.
Step 2A-Prone 1 (judicial exception). Yes, the claim cited judicial exceptions (i) a mixture of cyclic peptides and (ii) a natural compound of a caprylic/capric triglyceride.
Flaxseed comprises a mixture of claimed cyclic peptides according to the specification with a weight range as follows (p16, line 22 to p17, line 8). The specification indicates that the
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Met residues in these peptides can be oxidized (p7, line 3-5; p17, line 9-10) and the sequence listing explicitly sets forth that the sequences include oxidized versions. For example, the listing or SEQ ID NO: 4 indicates, “Met can be oxidized into sulfoxide or sulfone.” As such, “SEQ ID NO: 4” includes both cyclo-(Met-Leu-Val-Phe-Pro-Leu-Phe-Ile) comprising methionine with or without oxidation.
The claim further requires that the peptide mixture be present with a natural oil of caprylic/capric triglyceride as a physiologically acceptable medium. Yoo et al. (KR 2019076113, previously cited 1/16/2026) is cited as evidenced to show that caprylic/capric triglyceride is a natural oil and capable of being used in a cosmetic composition (See Yoo et al. English translation of abstract). Both ingredients as claimed exist in nature, and there is no evidence in the record that the combination of peptides and caprylic/capric triglyceride imparts new properties.
Step 2A-Prone 2 (whether the claim as whole integrates the recited judicial exception into a practical application of the exception). No, there is nothing in the claim to integrate the judicial exception (JE) into any particular practical application. The amounts in the claims are the amounts in which the cyclic peptides naturally occur and a physiologically acceptable medium of natural caprylic/capric triglyceride. The wherein clause described cyclic peptides made by a process comprising a solvent extract of flaxseeds; however, the solvent of ethanol is evaporated under vacuum, according to the specification (p16, line 21-26). The extraction solvent no longer exists in the cyclic peptide mixture composition comprising a natural oil of caprylic/capric triglyceride (See Yoo et al. English translation of abstract) as claimed.
Step 2B: No, there is nothing in the claim that causes it to amount to significantly more than the JE. The high level of generality for limitations including a physiologically acceptable medium of caprylic/capric triglyceride in a cosmetic composition is merely well-understood, routine, conventional activity as evidenced by CN107536748A (previously cited 1/16/2026) showing caprylic/capric triglyceride with moisturizing and anti-oxidant activity for maintenance skin barrier function (p8, English translation of abstract). Thus, the claim 29 as a whole with a combination of all elements amounts to significantly no more than the JEs. Again, the claim is drawn to a composition comprising a cyclic peptide mixture in a physiologically acceptable medium of caprylic/capric triglyceride in which the peptides exist naturally in flaxseed/linseed and caprylic/capric triglyceride is a natural oil.
Thus, claim 29 fails to satisfy 101 analyses.
Applicant’s Arguments
Caprylic/capric triglyceride is not found in nature and is prepared in a two-step process in which the first step is isolation of caprylic/capric acid from coconut oil and the second step is esterification of the caprylic/capric acid to form the caprylic/capric triglyceride (Remarks, p7, Rejection under 35 U.S.C 101).
Response to Arguments
Applicant's arguments filed 4/9/2026 have been fully considered but they are not persuasive because caprylic/capric triglyceride is a natural product as evidenced by Jadhav et al. (J Food Sci Technol (August 2023) 60(8):2143–2152) showing naturally medium-chain triglycerides (MCT defined in the abstract) comprising esterification of caprylic/capric acid (p2144, Fig 1) are found in coconut oil, palm kernel oil, and also in milk fat (p2145, col 1, Sources of medium chain triglycerides). Argument of translation of prior art reference with errors does not replace evidence where evidence is necessary. See MPEP 2145 (I).
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 19-20 and 27-30 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.
Claim 19 is unclear due to deletion of the transient word “comprising” at line 2, rendering the metes and bounds of claim 19 unclear. The preamble is drawn to a composition and the body of claim 19 has a close-ended transient phrase of “consisting of” to limit the active ingredient of cyclic peptides, but claim 19 further includes additional ingredient of sorbitan emulsifier and a process of solvent extract of flax seed oil. It is unclear whether the composition is limited to the active ingredient consisting of cyclic peptides or the composition comprises the active ingredient of cyclic peptides and other compound such as a physiologically acceptable medium of sorbitan emulsifier or solvent. Claims 20 and 27-28 are rejected as depending on claim 19.
For examination purposes, claim 19 is interpreted as a composition “comprising” a mixture of cyclic peptides and a sorbitan emulsifier.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 29 recites the broad recitation “comprising” (second to last line), and the claim also recites “consisting of” (second line) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim 30 is further rejected as depending on claim 29.
Modified Rejection
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.
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.
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.
1. Claims 19-20 and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Laarveld et al. (US 2014/0329741 A1, previously cited 6/15/2023) in view of Lintner (US 2004/0132667 A1) and CN107536748A (the CN-748 patent, previously cited 1/156/2026). The cyclic peptide sequences of linus cyclopeptide (LCP) can be found in the priority document of US 2014/0329741 A1 (provisional application No. 61/577,217 filed on Dec 19, 2011 NOT attached).
The broadest interpretation of claim 19 is drawn to a composition comprising a mixture of cyclic peptides isolated from flaxseed and a sorbitan emulsifier.
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Laarveld et al. teach the use of a linus cyclopeptide (LCP) extract from flaxseed for an active ingredient of natural product, food additive, or nutraceuticals in solid or liquid form
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[Abstract, 0073]. Laarveld et al. teach a natural product or pharmaceutical composition of the LCP extract from flaxseed oil comprises, consists essentially of or consists of LCP-1, LCP-2, LCP-3, LCP-4, LCP-5, LCP-6, LCP-7, LCP-8 and LCP-9 shown above [0066/weight ratio, claim 5]. Laarveld’s LCPs, see provisional application No. 61/577,217, corresponding to the claimed peptide structures are shown above. Laarveld et al. suggest the weight ratio of each LCPs preferably corresponding to their amounts found in the flaxseed and further suggest methionine sulfur atom is susceptible to oxidation in air upon standing [0066]. Although Laarveld et al. is silent on the range of LCP9 (the instant SEQ ID NO: 6), the range of LCP-9 is estimated to be in a range between 0-21% shown as follows overlapping with the claimed range of SEQ ID NO: 6 between 15 to 25%, reading on the
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weight ratio of mixed cyclic peptides as claimed. See MPEP 2144.05 (I) “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” Furthermore, Laarveld et al. teach the LCP extracts consists essentially of or consists of all LCP-1 to LCP-9 according to their amount in the flaxseed (claim 5-7) and further suggest the absolute amount of a single LCP is not critical and as long as the entire LCP extract administered in an effective amount to improve health of a subject (claim 1). Thus, the amount of each LCP in a composition is a result effective variable that can be determined by routine optimization for its intended use. Laarveld et al. teach LCPs has immunomodulation bioactivity in a skin condition known in the art [0004]. Laarveld et al. teach LCP extract from flaxseed is used as an antimicrobial agent against bacteria, viruses, fungi, and yeasts [0006, 0060]. Laarveld et al. further teach the use of extracted LCPs for treating soft tissue lesion (e.g., foot lesion) [0112]. Laarveld et al. also teach the compositions can be administered in various forms such as powder, a gel, a cream, or an ointment [0075], reading on topical composition in the preamble. Laarveld et al. further teach the use of an organic solvent of ethanol [0064] or methanol for the cyclic peptide isolation from flaxseed oil [0065], reading on the wherein clause.
Laarveld et al. dis not specify addition of sorbent as an emulsion carrier in formulation of the peptides.
Lintner teaches formulation of pharmaceutical, personal care and cosmetic compositions comprising bioactive peptides (Abstract). Lintner teaches in a preferred embodiment, where the composition is to be in contact with human keratinous tissue, the additional ingredients should be Suitable for application to keratinous tissue comprising hair, nails, skin, lips [0060] for topical or transdermal application in the form of emulsions [0019]. Lintner teaches an emulsion carrier [0189-0190] for formulation of bioactive peptides is an emulsifier of sorbitan monolaurate, polysorbitan trioleate, sorbitan monolaurate [0326] or other sorbitan linked fatty acids comprising isostearate, laurate, stearate, and trioleate [0273], reading on a physiologically acceptable medium comprising sorbitan emulsifier in claim 19. Because Lintner teaches formulation of pharmaceutical, personal care and cosmetic compositions comprising bioactive peptides by using an emulsifier of sorbitan conjugated fatty acid [0273, 0326] for topical or transdermal application [0019], one of ordinary skill in the art would have found it obvious to beneficially combine Laarveld’s bioactive cyclic peptides with Lintner’s sorbitan emulsifier for topical or transdermal application in the form of emulsions as suggested by Lintner [0019]. Lintner further teaches emollients of triglycerides of C8-C30 carboxylic acids can be further beneficially added to the formulation [0268]. Lintner further shows an emollient is Caprylic/Capric Triglyceride in Example 4 [0309] and in Example 7 [0315]. Similarly, CN-748 patent teaches an oiliness skin care composition administered to skin and moisten soft and smooth sensation (English translation p1, Abstract). CN-748 patent teaches the use of a preferred natural plant origin grease in a mixture of caprylic/capric triglyceride to overcome the problem of feeling greasy (English translation p2, The content of the invention 1-4).
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Laarveld et al. and (ii) Lintner’s teaching of emulsifier because (a) Laarveld et al. teach administration of a peptide composition to treat a skin condition [0004] or soft tissue lesion (e.g., foot lesion) [0112], and (b) Lintner teaches formulation of pharmaceutical, personal care and cosmetic compositions comprising bioactive peptides by using an emulsifier of sorbitan conjugated fatty acid [0273, 0326] for topical or transdermal application [0019]. The combination would have reasonable expectation of success because both references teach a peptide formulation for topical administration.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Laarveld et al. in view of Lintner with (ii) CN-748 patent because (a) Laarveld et al. in view of Lintner teach oiliness skin care composition for topical administration to keratinous tissue comprising hair, nails, skin, lips [0019, 0060] and (b) CN-748 patent teaches the use of a preferred natural plant origin grease in a mixture of caprylic/capric triglyceride to overcome the problem of feeling greasy (English translation p2, The content of the invention 1-4). The combination would have reasonable expectation of success because both Lintner and CN-748 patent teach the beneficial use of a mixture of caprylic/capric triglyceride in a skin care formulation.
With respect to claim 19, Laarveld et al. in view of Lintner and CN107536748A teach a skin care composition comprising cyclic peptides extracted from flaxseed and a physiologically acceptable medium comprising sorbitan linked fatty acid emulsifier. See the rejection above.
With respect to claim 20, Laarveld et al. further teach the use of an organic solvent of ethanol [0064] or methanol for the cyclic peptide isolation from flaxseed oil [0065].
With respect to claim 27, Lintner teaches an emulsion carrier [0189-0190] for formulation of bioactive peptides is an emulsifier of sorbitan monolaurate, polysorbitan trioleate, sorbitan monolaurate [0326] or other sorbitan linked fatty acids comprising isostearate, laurate, stearate, and trioleate [0273].
With respect to claim 28, Lintner further teaches emollients of triglycerides of C8-C30 carboxylic acids can be further beneficially added to the formulation [0268]. Lintner further shows an emollient is Caprylic/Capric Triglyceride in Example 4 [0309] and in Example 7 [0315]. Similarly, CN-748 patent teaches an oiliness skin care composition administered to skin and moisten soft and smooth sensation (English translation p1, Abstract). CN-748 patent teaches the use of a preferred natural plant origin grease in a mixture of caprylic/capric triglyceride to overcome the problem of feeling greasy (English translation p2, The content of the invention 1-4).
With respect to claim 29-30, Laarveld et al. in view of Lintner and CN107536748A teach a skin care composition comprising cyclic peptides extracted from flaxseed and a physiologically acceptable medium comprising a caprylic/capric triglyceride and sorbitan linked fatty acid emulsifier. See the rejection above.
Response to Arguments
Applicant's arguments filed 4/9/2026 have been fully considered but they are not persuasive because the arguments do not apply to the modified rejection based on Laarveld et al. (US 2014/0329741 A1, previously cited 6/15/2023) in view of Lintner (US 2004/0132667 A1) and CN107536748A (the CN-748 patent, previously cited 1/156/2026).
2. Claims 19-20 and 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over Laarveld et al. in view of Lintner and CN107536748A as applied to claims 19-20 and 27-30 and further in view of Gracioso et al. (FR3034314 with English translation and citation of teachings based on US 2018/0078481 A1 attached, previously cited 6/15/2023).
Claim 31 is drawn to a composition comprising a mixture of cyclic peptide isolated from flaxseed, a physiologically acceptable medium comprising a sorbitan emulsifier, and a mixture of sedanenolide, sedanolide and 3-nbutylphtalide isolate from Apium graveolens seeds.
Laarveld et al. in view of Lintner and CN107536748A teach a topical composition a mixture of cyclic peptide isolated from flaxseed, caprylic/capric triglyceride, and a physiologically acceptable medium comprising a sorbitan emulsifier as applied to claims 19-20 and 27-30 described above.
Laarveld et al. in view of Lintner and CN107536748A did not specify the composition further comprising a mixture of sedanenolide, sedanolide and 3-nbutylphtalide.
Gracioso et al. teach the use of at least one alkyl-phthalide or a plant extract comprising mainly said alkyl-phthalide in a topical cosmetic composition [Abstract, 0062] or suitable for transdermal administration [0064]. Gracioso et al. suggest alkyl-phthalide improve the mechanical properties of the dermal extracellular matrix (density, firmness, fine lines and wrinkles in particular) and to prevent and/or treat an oily skin [0022] by acting on skin microflora [0024] by enhancing production of antimicrobial peptide and reducing proliferation of germs [0119-0122; Table 1], limiting (reading on decreasing) the production of sebum of skin [0048] and stimulating collagen synthesis [0051]. Gracioso et al. teach the alkyl-phthalides comprise sedanenolide, sedanolide and/or 3-n-butylphthalide are most preferably isolated from seeds of the Apium graveolens plant [0052]. Gracioso et al. further suggest the alkyl-phthalide(s) or plant extract comprising such may be combined with other active ingredients at effective concentrations that can act synergistically or additionally for reinforcing and achieving the desired effects such as anti-inflammatory effect [0066] and/or antimicrobial effect by reducing germ proliferation (Table 1). Because Gracioso et al. suggest a combination of the alkyl-phthalide(s) or plant extract with other active ingredients at effective concentrations that can act synergistically or additionally for reinforcing and achieving the desired effects such as anti-inflammatory effect [0012] or antimicrobial effect by reducing germ proliferation (Table 1) via topical or transdermal administration [0064], one of ordinary skill in the art before the effective filing date of this invention would have found it obvious to beneficially combine Gracioso’s transdermal formulation of alkyl-phthalides [0064] with the composition taught by Laarveld et al. in view of CN107536748A having the same function of anti-microbial activity [0006] and anti-inflammatory [0106] that can act synergistically or additionally for reinforcing and achieving the desired effects as suggested by Gracioso et al. [0066], reading on claims 31-32.
One or ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Laarveld et al. in view of Lintner and CN107536748A with Gracioso et al. because (a) Laarveld et al. teach a composition comprising a mixture of LCPs extract from flaxseed with antimicrobial [0006] as well as anti-inflammatory [0106] activity suitable for transdermal administration [0076] and (b) Gracioso et al. further suggest the alkyl-phthalides or plant extract to be combined with other active ingredients at effective concentrations that can act synergistically or additionally for reinforcing and achieving the desired effects such as anti-inflammatory effect [0066] and/or antimicrobial effect by reducing germ proliferation (Table 1) for topical or transdermal use [0064]. The combination would have reasonable expectation of success because both references teach a composition with the same function having antimicrobial and anti-inflammatory effect suitable for transdermal administration.
Response to Arguments
Applicant's arguments filed 4/9/2026 have been fully considered but they are not persuasive because the arguments do not apply to the modified rejection based on Laarveld et al. (US 2014/0329741 A1, previously cited 6/15/2023) in view of Lintner (US 2004/0132667 A1), CN107536748A (the CN-748 patent, previously cited 1/156/2026) and further in view of Gracioso et al. (previously cited 6/15/2023).
Conclusion
No claim is allowed.
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.
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.
/J.L/Examiner, Art Unit 1658
28-June-2026
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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