DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 19, 2025 has been entered.
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 .
Priority
This Application filed on 10/26/2023 has PRO 63/420,202 filed on 10/28/2022, PRO 63/420,412 filed on 10/28/2022, and PRO 63/420,509 filed on 10/28/2022
Response to Arguments
Applicant’s arguments over the 35 U.S.C. 103 rejection over Bettle1 et al. (WO2019200364 - IDS) in view of Hobson (CN 1482925 A) and Hartsel et al. (US 20170022132 A1) of claims 1-14 is persuasive in view of the amendments made to the claims. The rejections is herewith withdrawn.
Applicant’s arguments over the 35 U.S.C. 103 rejection over Bettle2 (US 20170281689 A1) in view of Hobson (CN 1482925 A) and Hartsel et al. (US 20170022132 A1) as applied to claims 1-3, 5-7 is persuasive in view of the amendments made to the claims. The rejections is herewith withdrawn.
Applicant’s arguments over the 35 U.S.C. 103 rejection over Bettle2 (US 20170281689 A1) in view of Hobson (CN 1482925 A) and Hartsel et al. (US 20170022132 A1) as applied to claims 1-3, 5-7 above in view of Bettle1 et al. (WO2019200364 - IDS) as applied to claims 4, 8-14 is persuasive in view of the amendments made to the claims. The rejections is herewith withdrawn.
Applicant’s arguments over the 35 U.S.C. 103 rejection over Bettle2 (US 20170281689 A1) in view of Hobson (CN 1482925 A) and Hartsel et al. (US 20170022132 A1) as applied to claims 1-3, 5-7 above, in view of Davis (US9415082B1, hereinafter “Davis”); and Bettle3 (US2010/0074963A1 or ‘963 - IDS) as applied to claims 8-14 is persuasive in view of the amendments made to the claims. The rejections is herewith withdrawn.
Information Disclosure Statement
No new information disclosure statement(s) (IDS).
The rejections are as below:
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims have been amended to recite a “thermally treated halide salt, wherein the thermally treated halide salt comprises an increased surface charge density, thereby enabling enhanced solubilization in lipid-based carriers.” Additionally, wherein a combination of the camphor and the halide salt ”forms a stable ionic association with the marine oil and vegetable oil, whereby the halide salt, the marine oil, and the vegetable oil are encapsulated in a micelle structure, thereby facilitating localized ionic release at the application site.” The Examiner points out, in the specification:
[0190] Unexpectedly, benzethonium chloride, a halide salt that is not soluble in oil, may become soluble at about 185° F. only when camphor is in the formulation.
[0194] …unexpectedly, when benzethonium chloride is heated with marine oils and vegetable oils with more than 9% PUFA and/or camphor greater than or equal to 0.3 wt %, the lipid-insoluble halide salt becomes soluble in an anhydrous medium. For example, in some embodiments, the compositions may be produced by heating benzethonium chloride with 3% camphor into a clear liquid that remained clear even after freeze/thaw stress (e.g., 24 hours at about 2° C., then about 25° C.)
The Examiner finds no support in the specification for “forms a stable ionic association with the marine oil and vegetable oil, whereby the halide salt, the marine oil, and the vegetable oil are encapsulated in a micelle structure, thereby facilitating localized ionic release at the application site.” The Examiner finds no support in the specification for “comprises an increased surface charge density, thereby enabling enhanced solubilization in lipid-based carriers.” The specification do not recite any halide salt, as recited in the claims, or any thermally treated temperature as currently recited in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bettle4 et al. (WO2021216480A1).
Bettle4 et al. teaches an anhydrous topical pharmaceutical composition comprised of marine oil, such as fish oil or algae oil; vegetable oil having a an omega3 fat content greater than 9 wt %, such as hempseed oil, canola oil, flax seed oil, or cannabidiol; monolaurin, cetyl esters or wax; and medium chain triglycerides ("MCT"), and optionally fish collagen. The composition is useful for treating wounds, burns and skin conditions. (abstract) The reference collagen products are used to treat minor wounds by absorbing exudates and inhibiting bacterial growth with antimicrobials, like benzethonium chloride. [0037] Examples are taught to contain camphor. The compositions herein are in the form of an oil, gel, salve, cream, paste or whip. [0029] In the collagen containing compositions, if ascorbyl palmitate is present, it is present in about 0.3 to about 0.6 wt % of the composition, and in another embodiment, it is present at about 0.5 wt%. The composition of the present disclosure is a drug carrier for oil soluble drugs including pain killers, such as lidocaine and aspirin. [0031] For compositions comprised of collagen, all of the components except the collagen and sea salt and any fragrances are mixed together with stirring at a temperature sufficient to homogenously melt the components and form a homogenous paste. Typically, the composition is heated at temperatures ranging from about 130° F. to about 200° F. [0289]
While the reference teaches the benzethonium chloride and camphor, the reference is silent about a “thermally treated halide salt, wherein the thermally treated halide salt comprises an increased surface charge density, thereby enabling enhanced solubilization in lipid-based carriers and wherein a combination of the camphor and the halide salt ”forms a stable ionic association with the marine oil and vegetable oil, whereby the halide salt, the marine oil, and the vegetable oil are encapsulated in a micelle structure, thereby facilitating localized ionic release at the application site.”
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to heat the composition at temperatures ranging from about 130° F. to about 200° F, as suggested by Bettle4. The motivation to heat the composition at temperatures ranging from about 130° F. to about 200° F is because Bettle et al. teaches sufficiently homogenously melting the components and forming a homogenous paste. The skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-111 of U.S. Patent No. 17920162.
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending ‘162 claim and instant claims 1 require the same ingredients of monolaurin, cetyl esters, lidocaine, RBD palm oil, hempseed oil, cod liver oil, benzethonium chloride and same amounts thereof. The difference between them is that the claims herein refer to a “thermally treated halide salt, wherein the thermally treated halide salt comprises an increased surface charge density, thereby enabling enhanced solubilization in lipid-based carriers and wherein a combination of the camphor and the halide salt ”forms a stable ionic association with the marine oil and vegetable oil, whereby the halide salt, the marine oil, and the vegetable oil are encapsulated in a micelle structure, thereby facilitating localized ionic release at the application site.”
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to heat the composition at temperatures ranging from about 130° F. to about 200° F, as suggested by ‘162. The motivation to heat the composition at temperatures ranging from about 130° F. to about 200° F is because ‘162 teaches sufficiently homogenously melting the components and forming a homogenous paste. The skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
Conclusion
No claims allowed.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1627