Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-2, 4-5, 8-10, and 12-16 are pending and represent all claims currently under consideration.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/08/2026 has been entered.
Response to Arguments
Applicant's arguments filed 04/08/2026 have been fully considered but they are not persuasive.
Applicant states that Anderson does not teach the mass ratio of the amended claim (Remarks, page 5). This argument is not persuasive, because Anderson teaches the mass ratio of the amended claim as discussed below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claims 1-2, 4-5, 8-10, and 12-16 are considered to have an effective filing date of 11/11/2021.
New 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.
Claim 16 is 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.
Regarding claim 16, the claim recites the limitations "the dihydric alcohol" and “the total content of the dihydric alcohol”. There is insufficient antecedent basis for these limitations in the claim. Further, the parenthetical recitation of “mass of solution 1 / mass of solution 2” renders the claims indefinite because it is unclear whether the limitations in parentheses are part of the claimed invention or describing an example or preference. See MPEP § 2173.05(d).
Modified/Maintained 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.
Claims 1-2, 4-5, 8-10, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20100086573 A1; IDS reference, 05/03/2023), further in view of Chawrai (US 20160128944 A1). The references were cited previously by the Examiner.
Regarding claim 1, Anderson teaches a cosmetic formulation comprising a multilamellar liposomal particle suspension (i.e., lipid particles having a multilamellar structure; Anderson, page 11, paragraph 0130-0132) and exemplifies a composition comprising lecithin (i.e., a phospholipid), butylene glycol (i.e., a polyhydric alcohol), and water with no content of a trihydric or higher alcohol (i.e., 0%, which lies within the claimed range; Anderson, page 12, table 4). Anderson teaches the liposomal suspension includes at least one phospholipid or phospholipid mixture which can comprise lysophospholipids (Anderson, page 3, paragraph 0037), and teaches a phospholipid preparation comprising 80-95% by weight of phosphatidylcholine (Anderson, claim 5), which would result in a mass ratio of phosphatidylcholine (i.e., phospholipid) to other components of the mixture (i.e., lysophospholipids) of 4/1 to 19/1, overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Anderson teaches rigidity enhancers shift and/or stabilize the zeta potential of the liposomal particles (Anderson, page 4, paragraph 0044), but does not measure a specific zeta potential of the particles. Chawrai teaches a shampoo formulation (i.e., a cosmetic composition) with a lipid coated nanoparticle dispersion (i.e., lipid particles), propylene glycol (i.e., a polyhydric alcohol), and water with no content of a trihydric or higher alcohol (i.e., 0%, which lies within the claimed range; Chawrai, table 3, composition S1). Chawrai further teaches the lipid for use in the particle can be a phospholipid (Chawrai, page 10, paragraph 0075), and teaches a lipid nanoparticle dispersion with a zeta potential of 5.92 mV (Chawrai, table 35, composition D164), which lies within the claimed range of an absolute value of 5 mV or more.
Anderson and Chawrai are both considered to be analogous to the claimed invention, because Anderson, Chawrai, and the instant invention are in the same field of lipid particle cosmetic formulations. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize rigidity enhancers to stabilize the zeta potential of the lipid particles as taught by Anderson (Anderson, page 4, paragraph 0044), and it would be reasonable to optimize starting from a zeta potential known in the art to be stable in shampoo (i.e., cosmetic) formulations (Chawrai, claim 117) as taught by Chawrai.
Regarding claim 2, Anderson and Chawrai together teach all the elements of the current invention as applied to claim 1. Anderson teaches the liposomal suspension shows a mean (i.e., average) particle size of about 87 nm (Anderson, page 12, paragraph 0136), which lies within the claimed range of 10 nm or more.
Regarding claim 4, Anderson and Chawrai together teach all the elements of the current invention as applied to claim 1. Anderson further teaches a particle suspension 3G with an initial mean particle size of 125 nm and a mean particle size of 133.9 nm after 1 month at ambient temperature (Anderson, page 11, table 1), resulting in a rate of change of +7.1% which lies within the claimed range of ±20% or less.
Regarding claim 5, Anderson and Chawrai together teach all the elements of the current invention as applied to claim 1. Anderson teaches the liposome preparation is produced with a microfluidic device (Anderson, page 9, paragraph 0107).
Regarding claim 8, Anderson and Chawrai together teach all the elements of the current invention as applied to claim 1. Anderson teaches at least one phospholipid which comprises a glycerophospholipid (Anderson, claim 4).
Regarding claim 9, Anderson and Chawrai together teach all the elements of the current invention as applied to claim 1. Anderson teaches at least one phospholipid which comprises phosphatidylcholine (Anderson, claim 5).
Regarding claim 10, Anderson and Chawrai together teach all the elements of the current invention as applied to claim 1. Anderson teaches at least one rigidity enhancer which can be a photosterol or cholesterol (i.e., sterols; Anderson, claim 21).
Regarding claim 12, Anderson and Chawrai together teach all the elements of the current invention as applied to claim 1. Anderson teaches the composition comprises ceramide IIIB (i.e., a ceramide; Anderson, claim 15).
Regarding claim 13, Anderson and Chawrai together teach all the elements of the current invention as applied to claim 1. Anderson teaches the phospholipids in about 3% to about 8% by weight of the liposomal solution (i.e., 3 to 8 parts by mass of phospholipid in 100 parts by mass of lipid particles; Anderson, page 4, paragraph 0041), which overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Regarding claim 14, Anderson and Chawrai together teach all the elements of the current invention as applied to claim 1. Anderson teaches the liposomal suspension includes at least one phospholipid or phospholipid mixture which can comprise lysophospholipids (Anderson, page 3, paragraph 0037), and teaches the phospholipid mixture can comprise at least 90% by weight of phosphatidylcholine (i.e., 90 parts by mass; Anderson, page 4, paragraph 0042), which would result in a possible amount of other components of the mixture (i.e., lysophospholipids) of 10 parts by mass of the total phospholipids. Anderson teaches the phospholipids in about 3% to about 8% by weight of the liposomal solution (i.e., 3 to 8 parts by mass of phospholipid in 100 parts by mass of lipid particles; Anderson, page 4, paragraph 0041), which would result in about 0.3-0.8 parts by mass of the lysophospholipid in 100 parts by mass of lipid particles, and which lies within the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Regarding claim 15, Anderson and Chawrai together teach all the elements of the current invention as applied to claim 1. Anderson teaches reducing the mean diameter of the distribution of dispersed liposomal particles (i.e., polydispersity index) to minimize density differences (Anderson, page 1, paragraph 0004), but does not teach a specific polydispersity index. Chawrai teaches several particle compositions with PDI’s of as low as 0.0008 (Chawrai, page 47, table 1, composition D10), which lies within the claimed range. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reduce the mean diameter of the distribution of dispersed liposomal particles (i.e., polydispersity index) to minimize density differences (Anderson, page 1, paragraph 0004) as taught by Anderson, and it would be reasonable to optimize starting from a PDI known in the art, such as that as taught by Chawrai.
New Claim Rejections - 35 USC § 103
Regarding claim 16, Anderson teaches a cosmetic formulation comprising a multilamellar liposomal particle suspension (i.e., lipid particles having a multilamellar structure; Anderson, page 11, paragraph 0130-0132) and exemplifies a composition comprising lecithin (i.e., a phospholipid), butylene glycol (i.e., a polyhydric alcohol), and water with no content of a trihydric or higher alcohol (i.e., 0%, which lies within the claimed range; Anderson, page 12, table 4), which results in 100 parts by mass of the dihydric alcohol butylene glycol in 100 parts by mass of any dihydric and trihydric or higher alcohols.
Anderson teaches rigidity enhancers shift and/or stabilize the zeta potential of the liposomal particles (Anderson, page 4, paragraph 0044), but does not measure a specific zeta potential of the particles. Chawrai teaches a shampoo formulation (i.e., a cosmetic composition) with a lipid coated nanoparticle dispersion (i.e., lipid particles), propylene glycol (i.e., a polyhydric alcohol), and water with no content of a trihydric or higher alcohol (i.e., 0%, which lies within the claimed range; Chawrai, table 3, composition S1). Chawrai further teaches the lipid for use in the particle can be a phospholipid (Chawrai, page 10, paragraph 0075), and teaches a lipid nanoparticle dispersion with a zeta potential of 5.92 mV (Chawrai, table 35, composition D164), which lies within the claimed range of an absolute value of 5 mV or more.
The recitation of “the cosmetic composition or cosmetic quasi-drug is produced by mixing a lipid solution (solution 1) comprising a phospholipid and a polyhydric alcohol with a solution comprising water (solution 2) using a microfluidic device, a mixing ratio (mass of solution 1 / mass of solution 2) is from 99/1 to 1/99, a content of the polyhydric alcohol in 100 parts by mass of the lipid solution (solution 1) is from 5 parts by mass to 99.9 parts by mass, and a content of water in 100 parts by mass of the solution comprising water (solution 2) is 50 parts by mass or more” is considered to be a product-by-process claim. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113. In this case, Anderson and Chawrai teach the claimed composition as stated above. Anderson further teaches a liposomal suspension is prepared by adding water to an oil composition comprising each other ingredient and mixing with a microfluidizer (i.e., a microfluidic device; Anderson, page 11, paragraph 0130). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize rigidity enhancers to stabilize the zeta potential of the lipid particles as taught by Anderson (Anderson, page 4, paragraph 0044), and it would be reasonable to optimize starting from a zeta potential known in the art to be stable in shampoo (i.e., cosmetic) formulations (Chawrai, claim 117) as taught by Chawrai.
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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