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 .
DETAILED ACTION
Status of Claims
The amendments and arguments filed on 02/09/2026 are acknowledged and have been fully considered. Claims 1-23, 25-27, and 30-32 are now pending. Claims 24 and 28-29 are canceled; claims 23, 25-27, and 30-32 are amended; claims 1-22 are withdrawn.
Claims 23, 25-27, and 30-32 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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, and constitute the complete set presently being applied to the instant application.
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 23, 25-27, and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20220265672 A1 (Knie, 2022) in view of US PGPUB 20230149318 A1 (Lucas, 2023; filing date of 11/11/2022), WO 2022183292 A1 (Moustafa, 2022), and US PGPUB 20100135935 A1 (Leshchiner, 2010).
In regards to claims 23 and 25, Knie teaches a composition for transdermal administration in the form of a paste comprising an aqueous gel (see Knie, paragraphs 0138, 0147, 0177). The composition comprises lepodova (L-DOPA) (i.e., a hormone extract) (see Knie, paragraph 0090) and huperzine A (see Knie, paragraph 0069).
Knie is silent on the use of a plurality of herbal extracts, a cannabinoid compound, the gel comprising aloe vera gel and a cross-linked sodium hyaluronate polymer, and the amount of huperzine A in the composition.
In regards to claims 23 and 26-27, Lucas teaches a topical or transdermal composition (see Lucas, paragraphs 0043, 0220) comprising levodopa (see Lucas, paragraph 0111), Rhodiola Rosea, Bacopa Monnieri (see Lucas, paragraph 0164), and a cannabinoid such as cannabidiol (see Lucas, paragraph 0092).
In regards to claim 23, Leshchiner teaches a composition for use in transdermal application (see Leshschiner, paragraph 0034) comprising Hylasome (i.e., a cross-polymer of sodium hyaluronate) (see Leshschiner, paragraph 0043) and aloe vera gel (see Leshschiner, example 4; Table 1).
In regards to claims 23, 25-27, and 30-32, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate a composition as instantly claimed as the compounds of Lucas as mentioned above, are known to be used for increasing brain health (see Lucas, Tables 29 and 46), which would be beneficial in the composition of Knie as it is for treating Alzheimer’s disease (see Knie, abstract). Further, it is known in the art that cannabinoids, such as cannabidiol (see Moustafa, paragraph 0074) has a synergistic or additive effect when given with levodopa (see Moustafa, paragraphs 0075 and 0078) in transdermal administration (see Moustafa, paragraph 0133). It would be obvious to one with ordinary skill in the art to use the teachings of Leshschiner with the teachings of Knie, Lucas, and Moustafa, as Leshschiner teaches a composition with superior properties when compared to others, specifically the formation of a permeable, hydrated film on the surface of the skin that requires no environmental stimulus to deliever the active (see Leshschiner, paragraph 0042). Further, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One with ordinary skill in the art would be motivated to combine the compounds of Lucas with the composition of Knie according to the method of making a topical or transdermal composition (see Knie, paragraphs 0174-176; Leshschiner, examples 1-14) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
In regards to claims 30-32, it is taught that the dosage of the composition, particularly the “therapeutically effective amount” for any patient will depend “upon a variety of factors including the disorder being treated and the severity of the disorder; the specific composition employed; the age, body weight, general health, sex and diet of the patient; the time of administration; the route of administration; the rate of excretion of the specific compound employed; the duration of the treatment; drugs used in combination or coincidental with the specific compound employed and like factors well known in the medical arts” (see Lucas, paragraph 0044). As such, it is noted that the amount of drug is clearly a result effective variable that must be determined based on a variety of factors and is routinely optimized by the skilled artisan. Applicant is advised that recitation of dosages, without more, is generally insufficient to patentably distinguish over the prior art.
Response to Arguments
Applicant's arguments filed 02/09/2026 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regards to applicant’s arguments that the art does not teach the use of aloe vera gel or a cross-linked sodium hyaluronate polymer in the aqueous gel, it is noted that the rejection has been modified as necessitated by amendment to be over Knie in view of Lucas, Moustafa, and Leshschiner, the teachings of which have been described supra. Leshschiner teaches a composition with superior properties when compared to others, specifically the formation of a permeable, hydrated film on the surface of the skin that requires no environmental stimulus to deliver the active (see Leshschiner, paragraph 0042). Further, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One with ordinary skill in the art would be motivated to combine the compounds of Lucas with the composition of Knie according to the method of making a topical or transdermal composition (see Knie, paragraphs 0174-176; Leshschiner, examples 1-14) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
In regards to applicant’s arguments that Knie teaches a large list of therapeutic agents and does not identify that lepodova and huperzine A are used together, it is noted that Knie does teach that one or more of the additional therapeutics are used in the composition (see Knie, paragraph 0068). "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). Further, it had been decided by Courts that the indiscriminate selection of "some" from among "many" is considered prima facie obvious. In re Lemin, 141 USPQ 814 (1964); National Distillers and Chem. Corp. V. Brenner, 156 USPQ 163.
In response to applicant's argument that the prior art does not teach that specific compounds of the claims are taught to be used together in a single compound, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate a composition as instantly claimed as the compounds of Lucas as mentioned above, are known to be used for increasing brain health (see Lucas, Tables 29 and 46), which would be beneficial in the composition of Knie as it is for treating Alzheimer’s disease (see Knie, abstract). Further, it is known in the art that cannabinoids, such as cannabidiol (see Moustafa, paragraph 0074) has a synergistic or additive effect when given with levodopa (see Moustafa, paragraphs 0075 and 0078) in transdermal administration (see Moustafa, paragraph 0133). It would be obvious to one with ordinary skill in the art to use the teachings of Leshschiner with the teachings of Knie, Lucas, and Moustafa, as Leshschiner teaches a composition with superior properties when compared to others, specifically the formation of a permeable, hydrated film on the surface of the skin that requires no environmental stimulus to deliever the active (see Leshschiner, paragraph 0042). Further, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One with ordinary skill in the art would be motivated to combine the compounds of Lucas with the composition of Knie according to the method of making a topical or transdermal composition (see Knie, paragraphs 0174-176; Leshschiner, examples 1-14) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Double Patenting
The terminal disclaimer of 02/09/2026 is sufficient to overcome the previous provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
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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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611
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