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 .
Election/Restrictions
Applicants’ election of Group I (claims 1-13 and 15) drawn to a composition comprising at least one particle comprising at least one cationic polymer, anionic polymer and non-polymeric acid having two or more pKa values or salts thereof; at least one oil; at least one fatty acid and water, is acknowledged. The election was made without traverse.
Applicants’ election for the species of polylysine and sodium hyaluronate, is acknowledged; however, such election of species is hereby withdrawn in view of the prior art search.
As the requirement for restriction is deemed proper, it is maintained and hereby made FINAL.
Claim 14 is hereby withdrawn from further consideration by the Examiner, pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. The instant claims have been examined commensurate with the scope of the elected invention. Applicants timely responded to the restriction requirement in the reply filed 5/15/26.
Accordingly, claims 1-13 and 15 are under current examination.
Status of Claims
No new claim set was filed in response to the Restriction/Election requirement.
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 15 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claim Rejections - 35 USC § 112(b)
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.
Claims 3-12 and 15 are 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 claims 3 and 5, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examiner notes that there are 3 iterations of “such as” in claim 3 and 2 in claim 5.
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 4 recites the broad recitation 0.001% to 15%, and the claim also recites 0.005% to 10% or 0.01% to 5% 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. Claims 6-12 and 15 also recite broad limitations (prior to “preferably” or “more preferably”) followed by narrow limitations (after “preferably” or “more preferably”).
Claim 15 provides for the use of “at least one fatty acid in a composition” but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shiroya et al. (US 2020/0163866; published: 5/28/20).
Shiroya is directed to compositions comprising polyion complex particle and oil [Title].
With regards to instant claims 1 and 15, Shiroya teaches a composition comprising (a) at least one particle, comprising at least one cationic polymer, at least one anionic polymer and at least one non-polymeric acid having two or more pKa values or salt(s) thereof; (b) at least one oil; and (c) water [claim 1 and Abstract]. Shiroya teaches that the composition according to the invention may also comprise at least one fatty acid [0543].
With regards to instant claim 2, Shiroya teaches that the fatty acid may be useful for controlling the hydrophobicity of the (a) particles which may influence the encapsulation ability of the (a) particles, depending on the type of the (b) oil.
With regards to instant claim 3, Shiroya teaches that the cationic polymer may be selected from the group consisting of cyclopolymers of alkyldiallylamine and cyclopolymers of dialkyldiallylammonium such as (co)polydiallyldialkyl ammonium chloride, (co)polyamines such as (co)polylysines and chitosans, cationic (co)polyaminoacids such as collagen, and salts thereof [0023].
With regards to instant claim 4, Shiroya teaches that the amount of the cationic polymer(s) in the composition according to the present invention may be from 0.001 to 25% by weight, preferably from 0.1 to 20% by weight, and more preferably from 1 to 15% by weight, relative to the total weight of the composition (underlined range is completely within the claimed range) [0197].
With regards to instant claim 5, Shiroya teaches that the anionic polymer be selected from the group consisting of polysaccharides such as alginic acid, hyaluronic acid, and cellulose polymers (e.g., carboxymethylcellulose), anionic (co)polyaminoacids such as (co)polyglutamic acids, (co)poly(meth)acrylic acids, (co)polyamic acids, (co)polystyrene sulfonate, (co)poly(vinyl sulfate), dextran sulfate, chondroitin sulfate, (co)polymaleic acids, (co)polyfumaric acids, maleic acid (co)polymers, and salts thereof [0227].
With regards to instant claim 6, Shiroya teaches that the amount of the anionic polymer(s) in the composition according to the present invention may be from 0.001 to 25% by weight, preferably from 0.1 to 20% by weight, and more preferably from 1 to 15% by weight, relative to the total weight of the composition (underlined range is completely within the claimed range) [0239].
With regards to instant claim 7, Shiroya teaches that the non-polymeric acid having two or more pKa values or salt(s) thereof may be an organic acid or salt(s) thereof, and preferably a hydrophilic or water-soluble organic acid or salt(s) thereof [0376].
With regards to instant claim 8, Shiroya teaches that the amount of the non-polymeric acid having two or more pKa values or salt(s) thereof in the composition according to the present invention may be from 0.0001 to 30% by weight, preferably from 0.01 to 20% by weight, and more preferably from 0.1 to 15% by weight, relative to the total weight of the composition (underlined range is completely within the claimed range) [0384].
With regards to instant claim 9, Shiroya teaches that the amount of the (a) particle(s) in the composition according to the present invention may be from 0.001 to 60% by weight, preferably from 0.1 to 50% by weight, and more preferably from 1 to 40% by weight, relative to the total weight of the composition (ranges taught completely overlaps with claimed ranges) [0107].
With regards to instant claims 10 and 15, Shiroya teaches that the amount of the (b) oil(s) in the composition according to the present invention may be 0.01% by weight or more, preferably 0.1% by weight or more, and more preferably 1% by weight or more, relative to the total weight of the composition [0361]. Furthermore, Shiroya teaches that the amount of the (b) oil(s) in the composition according to the present invention may be from 0.01 to 50% by weight, preferably from 0.1 to 40% by weight, and more preferably from 1 to 35% by weight, relative to the total weight of the composition (ranges taught completely overlaps with claimed ranges) [0363].
With regards to instant claim 11, Shiroya teaches that the composition according to the present invention may comprise the above optional additive(s) (e.g., fatty acid) in an amount of from 0.01 to 50% by weight, preferably from 0.05 to 30% by weight, and more preferably from 0.1 to 10% by weight, relative to the total weight of the composition (ranges taught completely overlaps with claimed ranges) [0544].
With regards to instant claim 12, Shiroya teaches that the amount of the (c) water may be from 40 to 90% by weight, preferably from 50 to 80% by weight, and more preferably from 60 to 70% by weight, relative to the total weight of the composition (ranges taught completely overlaps with claimed ranges) [0368].
With regards to instant claim 13, Shiroya teaches that since the composition according to the present invention comprises at least one (b) oil, the composition according to the present invention can comprise at least one fatty phase [0547]. Shiroya also teaches that a plurality of the (a) particles can be present at the interface between the (b) oil and the (c) water. Thus, the (a) particles can form an emulsion. For example, if the (c) water constitutes a continuous phase and the (b) oil constitutes dispersed phases, the (a) particles can form an O/W emulsion which may be similar to a so-called Pickering emulsion [0108].
Therefore, by teaching all the limitations of claims 1-13 and 15, Shiroya anticipates the instant invention as claimed.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-13 and 15 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over:
claims 1-12 of copending Application No. 18/719,683;
claims 1-14 of copending Application No. 19/115,113;
claims 1-14 of copending Application No. 19/117,907; and
claims 1-11 of copending Application No. 19/139,793
in view of Shiroya et al. (US 2020/0163866). Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising (a) at least one particle, comprising at least one cationic polymer (0.01-15 wt%; e.g., cyclopolymers of dialkyldiallylammonium or polylysine), at least one anionic polymer (0.01-15 wt%; e.g., hyaluronic acid), and at least one non-polymeric acid having two or more pKa values or a salt thereof (0.001-10 wt%; e.g., organic acid or salt thereof); (b) at least one oil; and (d) water (50-95 wt%). The difference is that the instant application recites an additional component to the composition: a fatty acid (0.01-15 wt%) that hydrophobicizes the particle. However, Shiroya teaches that the composition according to the invention may also comprise at least one fatty acid and that the fatty acid may be useful for controlling the hydrophobicity of the (a) particles which may influence the encapsulation ability of the (a) particles, depending on the type of the (b) oil [0543]. Therefore, it would have been obvious to one of ordinary skill in the art to further incorporate a fatty acid into the composition to influence the encapsulation ability of the particles. Thus, the instant claims and the application claims are obvious variants. It is noted that the instant claims use the “comprising” language and therefore the additional components in the copending claims are not excluded.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1-13 and 15 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over:
claims 1-11 of U.S. Patent No. 11,389,379;
claims 1-16 of U.S. Patent No. 11,819,564;
claims 1-13 of U.S. Patent No. 11,975,093; and
claims 1-12 of U.S. Patent No. 12,453,691
in view of Shiroya et al. (US 2020/0163866). Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising (a) at least one particle (0.01-60 wt% or 0.01-30 wt%), comprising at least one cationic polymer (0.01-15 wt%; e.g., polylysine or cyclopolymers of dialkyldiallylammonium), at least one anionic polymer (0.01-15 wt%; cellulose polymers or hyaluronic acid), and at least one non-polymeric acid having two or more pKa values or a salt thereof (0.001-10 wt%; e.g., organic acid or salt thereof); (b) at least one oil; and (d) water (50-95 wt%). The difference is that the instant application recites an additional component to the composition: a fatty acid (0.01-15 wt%) that hydrophobicizes the particle. However, Shiroya teaches that the composition according to the invention may also comprise at least one fatty acid and that the fatty acid may be useful for controlling the hydrophobicity of the (a) particles which may influence the encapsulation ability of the (a) particles, depending on the type of the (b) oil [0543]. Therefore, it would have been obvious to one of ordinary skill in the art to further incorporate a fatty acid into the composition to influence the encapsulation ability of the particles. Thus, the instant claims and the application claims are obvious variants. It is noted that the instant claims use the “comprising” language and therefore the additional components in the copending claims are not excluded.
Claims 1-13 and 15 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,452,676, in view of Shiroya et al. (US 2020/0163866). Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising (a) at least one particle (0.01-60 wt% or 0.01-30 wt%), comprising at least one cationic polymer (0.01-15 wt%; e.g., polylysine or cyclopolymers of dialkyldiallylammonium), at least one anionic polymer (0.01-15 wt%; cellulose polymers or hyaluronic acid), and at least one non-polymeric acid having two or more pKa values or a salt thereof (0.001-10 wt%; e.g., organic acid or salt thereof); (b) at least one oil; and (d) water (50-95 wt%). The difference is that the instant application recites an additional component to the composition: a fatty acid (0.01-15 wt%) that hydrophobicizes the particle and at least one non-polymeric acid having two or more pKa values or a salt thereof. However, Shiroya teaches that the composition according to the invention may also comprise at least one fatty acid and that the fatty acid may be useful for controlling the hydrophobicity of the (a) particles which may influence the encapsulation ability of the (a) particles, depending on the type of the (b) oil [0543]. Therefore, it would have been obvious to one of ordinary skill in the art to further incorporate a fatty acid into the composition to influence the encapsulation ability of the particles. Thus, the instant claims and the application claims are obvious variants. It is noted that the instant claims use the “comprising” language and therefore the additional components in the copending claims are not excluded.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/Primary Examiner, Art Unit 1617
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