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 .
Withdrawn Rejections:
The rejection of claims 1, 4-6, 12, and 14-16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn because of the amendment of the claims so that a broad range or limitation together with a narrow range or limitation, is no longer recited in the same claim.
The rejection of claims 1, 4-6, 12 and 14-16 under 35 U.S.C. 102(a)(1) as being anticipated by Hun of record (KR20030064986A, published 08/06/2003, Machine Translation and Original used), is withdrawn because of the amendment of the claims (e.g., claim 1), to newly introduced the limitation of a thread-like molecular aggregate composed of a phospholipid and a biosurfactant having a structure of threads entangled with each other.
The rejection of claims 1, 4-6, 12, and 14-16 on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Application No. 17/785,170, is withdrawn because the Applicant has submitted a Terminal Disclaimer under 35 C.F.R. § 1:321(c) in the reply filed on 12/04/2025. Please note that the Terminal Disclaimer is effective with respect to all claims in the instant application. See MPEP § 804.02.
The rejection of claims 1, 4-6, 12, and 14-16 on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Application Nos: 1) 18/589,817 (inadvertently recited in the previous Office action as 18/598,817); 2) 19/088,104; and 3)19/092,456, is withdrawn because of the Applicant’s arguments on the grounds that none of reference U.S. Patent Applications recite a polyol in a claim or disclose a polyol in their respective specifications (see pages 9-10 of Remarks). Applicant’s arguments have been fully considered and are found to be persuasive.
Status of the Claims
Claims 1, 3-6, 12 and 14-21 are pending.
Applicants’ arguments, filed on 12/04/2025, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments filed on 12/04/2025, have been fully considered. Applicants have amended claims 1, 3, 12 and 14. Applicants have cancelled claims 2 and 13. Applicants have newly added claims 17-21. Therefore, claims 1, 3-6, 12 and 14-21 are subject of the Office action below.
Maintained Rejections:
Claim Rejections - 35 USC § 112-Maintained
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.
The rejection of claim 3 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is maintained for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated.
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 3 recites the broad recitation “1 part by mass to 20 parts”, and the claim also recites “or less”, 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.
This lack of clarity makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected. Appropriate correction is required.
Response to the Applicant’s Arguments
Applicant argues on the grounds that the amendment of claim allegedly obviates the rejection (see page 6 of Remarks).
Response:
Applicant’s arguments have been fully considered but they are not found to be persuasive, because claim 3 recites the broad recitation “1 part by mass to 20 parts”, and the claim also recites “or less”, which is the narrower statement of the range/limitation.
Claim Rejections - 35 USC § 103
New Grounds of Rejection Necessitated by Applicant’s Amendments
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.
Claims 1, 3-6, 12 and 14-21 are rejected under 35 U.S.C. 103 as being unpatentable over Hun of record (KR20030064986A, published 08/06/2003, Machine Translation and Original used), in view of Deleu et al (hereinafter “Deleu” Biophysical J., 2008, 94, 2667-2679).
By way of a background, Applicants’ invention is drawn to a cosmetic topical composition comprising a lipopeptide compound of formula (II):
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, or a salt thereof, and a phospholipid (see, e.g., ¶s 0001 and 0006-0008 of the specification), which forms a thread-like molecular aggregate that can be observed using a cryo electron microscopy (Cryo-EM) technique (Freeze-fracture transmission electron microscopy, FF-TEM, see, e.g., ¶s 0012 and 0044 of the specification).
Under the broadest reasonable interpretation (BRI), consistent with the specification, Applicants’ invention is being interpreted as a thread-like molecular aggregate comprising:
a lipopeptide compound of formula (II) and a phospholipid; and
a polyol,
wherein a ratio of the phospholipid to 1 part by mass of the surfactin is from 4 parts by mass to 10 parts o by mass.
Regarding claims 1 and 12, Hun (see Example 1, ¶ 31), teaches a composition and a method for preparing the composition, comprising:
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The 2 g (1.0 wt%) lecithin is a phospholipid (see, e.g., ¶ 12 of Hun and ¶s 0020-0022 of the specification).
The 0.1 g (0.1 wt%) surfactin, is a lipopeptide compound of formula (II), wherein R = C12 (see page 4 of the original patent document).
Ratio of phospholipid to surfactin (1.0/0.1) = 10.
The 4 g (2.0 wt%) hexanediol is a polyol (see, e.g., ¶ 20 of Hun).
Ratio of polyol to surfactin (2.0/0.1) = 20.
Although Hun is not explicit to disclosing a formation of thread-like molecular aggregate from phospholipid and surfactin, one skilled in the art would have had a reasonable expectation of success in observing a thread-like molecular aggregate using a Cryo-EM. This is because at the time of the instant invention, it was known in the art that a phospholipid and a lipopeptide forms entangled thread-like aggregates, which can be observed using a Cryo-EM.
For example, Deleu teaches formation of entangled thread-like aggregates from a phospholipid and a lipopeptide, which can be observed using a Cryo-TEM (see page 2675, ¶ 3, abstract and discussions therein). Even if the micrograph does not allow the micelle to be properly observed, their existence is assumed on the basis of previous study (see page 2675, ¶ 3). Cryo-TEM provides information on the structural organization of the lipid/lipopeptide system (see abstract).
Therefore, claims 1 and 12 are obvious over Hun and Deleu.
Regarding claims 3 and 14, the 4 g (2.0 wt%) hexanediol is a polyol (see, e.g., ¶ 20 of Hun), and the ratio of the polyol to surfactin (2.0/0.1) = 20.
Regarding claims 4 and 15, Hun teaches a compound of formula (II), wherein R = C12 (see discussions above).
Regarding claims 5-6, Hun teaches a cosmetic composition (see discussions above).
Regarding claim 16, Hun teaches 0.1 wt% surfactin (see discussions above).
Regarding claim 17, Hun teaches a composition of claim 1 (see discussions above).
Regarding claims 18-19, Hun teaches phosphatidylcholine (see ¶ 12).
Regarding claim 20, the recited ratio of phospholipid/surfactin, is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art. For example, Hun discloses that:
i) surfactin can be in an amount of 0.005-5 wt%, preferably, 0.1-1 wt% (see ¶ 18); and
ii) phospholipid can be in an amount of 0.1-20 wt%, preferably, 0.5-8.0 wt% (see ¶ 21).
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
Regarding claim 21, the exhibition of a thixotropic property, is a property of a composition of claim 1. Since Hun and Deleu combine to disclose a composition of claim 1 (see discussions above), the composition of Hun and Deleu must necessarily exhibit a thixotropic property.
An inherent characteristic may “be part of the prior art in an obviousness analysis even if the inherent characteristic was unrecognized or unappreciated by a skilled artisan.” Endo Pharm. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 1381 (Fed. Cir. 2018).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Response to the Applicant’s Arguments
Applicant argues against the Hun reference on the grounds that:
1) the Hun teaches an emulsion having particle size between 10 nm and 100 nm (see pages 7-8 of Remarks).
Response:
Applicant’s arguments have been fully considered but they are not found to be persuasive, because the specification (see ¶ 0033), discloses particle size of between 5 nm and 40 nm for the thread-like molecular aggregate, which lies or overlaps with between 10 nm and 100 nm.
Although Hun is not explicit to disclosing a formation of thread-like molecular aggregate from phospholipid and surfactin, one skilled in the art would have had a reasonable expectation of success in observing a thread-like molecular aggregate using a Cryo-EM. This is because at the time of the instant invention, it was known in the art that a phospholipid and a lipopeptide forms entangled thread-like aggregates, which can be observed using a Cryo-EM.
For example, Deleu teaches formation of entangled thread-like aggregates from a phospholipid and a lipopeptide, which can be observed using a Cryo-TEM (see page 2675, ¶ 3, abstract and discussions therein). Even if the micrograph does not allow the micelle to be properly observed, their existence is assumed on the basis of previous study (see page 2675, ¶ 3). Cryo-TEM provides information on the structural organization of the lipid/lipopeptide system (see abstract).
Claims 1, 3-6, 12 and 14-21 are rejected under 35 U.S.C. 103 as being unpatentable over Yoneda (U.S. Pub. No. 20070190087, published 08/16/2007), as evidenced by Ceci et al (hereinafter “Ceci”, J. Sci. Food Agric., 2008, 88, 2460-2466), and in view of Deleu et al (hereinafter “Deleu” Biophysical J., 2008, 94, 2667-2679).
Regarding claims 1, 3-6, 12 and 14-21, Yoneda (see ¶s 0010, 0012), discloses a thickening composition and a cosmetic product comprising a lipopeptide (e.g., surfactin, see ¶ 0013), an oil component (e.g., soybean oil, see ¶ 0037), and a polyol.
The lipopeptide can be in amount of 0.01-5 wt% (see ¶ 0013).
The oil can be in amount of 30-99 wt% (see ¶ 0013).
The polyol can be in amount of 0.01-70 wt% (see ¶ 0013).
Although Yoneda is not explicit in disclosing phospholipid, soybean oil comprises phospholipids such as phosphatidylcholine as evidenced by Ceci1.
Accordingly, at the time of the instant invention, a person skilled in the art would have understood that Yoneda contemplates a thickening composition comprising surfactin, phospholipid and a polyol. One skilled in the art would have envisioned a thickening composition comprising surfactin, phospholipid and a polyol, in the Yoneda disclosure.
Although Yoneda as evidenced by Ceci is not explicit to disclosing a formation of thread-like molecular aggregate from phospholipid and surfactin, one skilled in the art would have had a reasonable expectation of success in observing a thread-like molecular aggregate using a Cryo-EM. This is because at the time of the instant invention, it was known in the art that a phospholipid and a lipopeptide forms entangled thread-like aggregates, which can be observed using a Cryo-EM.
For example, Deleu teaches formation of entangled thread-like aggregates from a phospholipid and a lipopeptide, which can be observed using a Cryo-TEM (see page 2675, ¶ 3, abstract and discussions therein). Even if the micrograph does not allow the micelle to be properly observed, their existence is assumed on the basis of previous study (see page 2675, ¶ 3). Cryo-TEM provides information on the structural organization of the lipid/lipopeptide system (see abstract).
Regarding claims 1, 3, 12, 14 and 20, each of the recited ratio of: i) phospholipid/surfactin (claims 1, 12 and 20); and ii) polyol/surfactin (claims 3 and 14), is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art. For example, Yoneda (see discussions above), discloses that the: i) lipopeptide can be in amount of 0.01-5 wt%; ii) oil can be in amount of 30-99 wt%; and iii) polyol can be in amount of 0.01-70 wt%.
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
Regarding claim 21, the exhibition of a thixotropic property, is a property of a composition of claim 1. Since Yoneda as evidenced by Ceci and Deleu combine to disclose a composition of claim 1 (see discussions above), the composition of Yoneda as evidenced by Ceci and Deleu must necessarily exhibit a thixotropic property.
An inherent characteristic may “be part of the prior art in an obviousness analysis even if the inherent characteristic was unrecognized or unappreciated by a skilled artisan.” Endo Pharm. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 1381 (Fed. Cir. 2018).
Therefore, claims 1, 3-6, 12 and 14-21 are obvious over Yoneda as evidenced by Ceci and Deleu.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Conclusion
No claim is allowable.
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.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
1 See page 2460.