DETAILED ACTION
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 12-23 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 08/05/2026 has been entered.
Claims 1 and 16 were amended. Claims 17-23 were added. No new material was added.
Applicant’s amendments overcome the previous rejections of claim 16 under 35 U.S.C. 112(b), and of claims 1-2, 4-5, 8-10, and 12-16 under 35 U.S.C. 103.
Claims 1-2, 4-5, 8-10, and 12-23 are newly rejected under 35 U.S.C. 103 due to the amendment.
Response to Arguments
Applicant’s arguments, see Remarks (pages 7-8), filed 08/05/2026, with respect to the rejection(s) of claim(s) 1-2, 4-5, 8-10, and 12-16 under 35 U.S.C. 103 over Anderson and Chawrai have been fully considered and are persuasive. Therefore, the rejection has been withdrawn However, upon further consideration, a new ground(s) of rejection is made in view of Anderson and Karnik.
Applicant argues that there would have been no reason to modify Anderson to arrive at a cosmetic composition or cosmetic quasi-drug composition comprising lipid particles having the recited zeta potential (Remarks, page 8). This argument is not persuasive, because as previously stated, Anderson teaches shifting and/or stabilizing of the zeta potential of the liposomal particles (Anderson, page 4, paragraph 0044), but does not measure a specific zeta potential of the particles. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to optimize the zeta potential based on a range known in the art.
Applicant argues that Anderson fails to disclose a content of cholesterol in 100 parts by mass of the lipid particles of from 1 to 35 parts by mass. This argument is not persuasive, because Anderson teaches cholesterol in an amount of about 0.01-1% by weight (Anderson, page 4, paragraph 0052), which overlaps the claimed range of 1-35 parts by mass. 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).
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 12-23 are considered to have an effective filing date of 11/11/2021.
New Claim Objections
Applicant is advised that should claim 21 be found allowable, claim 22 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
New 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, 12-14, and 16-23 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 Karnik (US 20100022680 A1; IDS reference, 05/03/2023). Anderson was 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 shifting and/or stabilizing of the zeta potential of the liposomal particles (Anderson, page 4, paragraph 0044), but does not measure a specific zeta potential of the particles. Karnik teaches lipid particles (Karnik, page 4, paragraph 0044), which can comprise phospholipids (Karnik, page 12, paragraph 0136), and teaches a zeta potential ranging from -50 mV to -40 mV (i.e., an absolute value of a zeta potential more than 30 mV; Karnik, page 20, paragraph 0220).
Anderson and Karnik are both considered to be analogous to the claimed invention, because Anderson, Karnik, 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.
Regarding claim 2, Anderson and Karnik 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 Karnik 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 Karnik 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 Karnik 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 Karnik 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 Karnik 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 Karnik 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 Karnik 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 Karnik 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 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 shifting and/or stabilizing of the zeta potential of the liposomal particles (Anderson, page 4, paragraph 0044), but does not measure a specific zeta potential of the particles. Karnik teaches lipid particles (Karnik, page 4, paragraph 0044), which can comprise phospholipids (Karnik, page 12, paragraph 0136), and teaches a zeta potential ranging from -50 mV to -40 mV (i.e., an absolute value of a zeta potential more than 30 mV; Karnik, page 20, paragraph 0220).
The recitation of “the cosmetic composition or cosmetic quasi-drug is produced by mixing a lipid solution comprising a phospholipid and a polyhydric alcohol with a water solution comprising water using a microfluidic device, a mass mixing ratio in terms of lipid solution / water solution is from 99/1 to 1/99, a content of the polyhydric alcohol in 100 parts by mass of the lipid solution is from 5 parts by mass to 99.9 parts by mass, and a content of water in 100 parts by mass of the water solution 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 Karnik 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.
Regarding claim 17, Anderson and Karnik together teach all the elements of the current invention as applied to claim 1. As above, Anderson teaches shifting and/or stabilizing of the zeta potential of the liposomal particles (Anderson, page 4, paragraph 0044), but does not measure a specific zeta potential of the particles. Karnik teaches lipid particles (Karnik, page 4, paragraph 0044), which can comprise phospholipids (Karnik, page 12, paragraph 0136), and teaches a zeta potential ranging from -50 mV to -40 mV (i.e., a zeta potential less than -30 mV; Karnik, page 20, paragraph 0220). 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.
Regarding claim 18, Anderson and Karnik together teach all the elements of the current invention as applied to claim 1. Anderson teaches a cosmetic formulation comprising butylene glycol (i.e., a polyhydric alcohol) in an amount of 4% by weight (Anderson, page 12, table 4), which lies within the claimed range of 3% by mass or more.
Regarding claim 19, Anderson and Karnik together teach all the elements of the current invention as applied to claim 16. As above, Anderson teaches shifting and/or stabilizing of the zeta potential of the liposomal particles (Anderson, page 4, paragraph 0044), but does not measure a specific zeta potential of the particles. Karnik teaches lipid particles (Karnik, page 4, paragraph 0044), which can comprise phospholipids (Karnik, page 12, paragraph 0136), and teaches a zeta potential ranging from -50 mV to -40 mV (i.e., a zeta potential less than -30 mV; Karnik, page 20, paragraph 0220). 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.
Regarding claim 20, Anderson and Karnik together teach all the elements of the current invention as applied to claim 16. Anderson teaches a cosmetic formulation comprising butylene glycol (i.e., a polyhydric alcohol) in an amount of 4% by weight (Anderson, page 12, table 4), which lies within the claimed range of 3% by mass or more.
Regarding claim 21, 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. Anderson teaches at least one rigidity enhancer which can be a cholesterol (i.e., sterols; Anderson, claim 21) in an amount of about 0.01-1% by weight (Anderson, page 4, paragraph 0052), which overlaps the claimed range of 1-35 parts by mass. 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 shifting and/or stabilizing of the zeta potential of the liposomal particles (Anderson, page 4, paragraph 0044), but does not measure a specific zeta potential of the particles. Karnik teaches lipid particles (Karnik, page 4, paragraph 0044), which can comprise phospholipids (Karnik, page 12, paragraph 0136), and teaches a zeta potential ranging from -50 mV to -40 mV (i.e., an absolute value of a zeta potential more than 30 mV; Karnik, page 20, paragraph 0220). 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.
Regarding claim 22, Anderson and Karnik together teach all the elements of the current invention as applied to claim 1. Anderson teaches a cosmetic formulation comprising at least one rigidity enhancer which can be a cholesterol (i.e., sterols; Anderson, claim 21) in an amount of about 0.01-1% by weight (Anderson, page 4, paragraph 0052), which overlaps the claimed range of 1-35 parts by mass. 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 23, Anderson and Karnik 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), and teaches ceramides in an amount of about 0.01-1% by weight (Anderson, page 4, paragraph 0049), 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).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20100086573 A1; IDS reference, 05/03/2023) and Karnik (US 20100022680 A1; IDS reference, 05/03/2023) as applied to claims 1-2, 4-5, 8-10, 12-14, and 16-23, and as evidenced by NanoTemper Tech. Anderson was cited previously by the Examiner.
Regarding claim 15, Anderson and Karnik 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. Karnik teaches it is desirable to yield monodispersed particle formulations (Karnik, page 4, paragraph 0050), and that the particles produced are highly monodisperse in size (Karnik, page 23, example 2). As evidenced by NanoTemper Tech, a highly monodisperse PDI would be less than 0.1, 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 as taught by Anderson, and it would be reasonable to optimize for a highly monodisperse particle formulation as taught by Karnik to be desirable in the field.
Conclusion
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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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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