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 .
Priority
This application, filed 19 October, 2022, is a national stage application of PCT/US2022/080453, filed 23 November, 2022, which claims prior benefit of provisional applications PRO 63/401,918, filed 29 August 2022 and PRO 63/283,121, filed 24 November, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 27 February, 2024 is acknowledged and has been considered.
Election/Restrictions
Applicant previously elected an invention with traverse in response to the restriction requirement set forth in the prior Office Action filed 13 March, 2026. Upon consideration of Applicant’s amendments, the restriction requirement is hereby withdrawn because the pending claims no longer present independent or distinct inventions requiring restriction.
Accordingly, all pending claims are being examined on their merits in the present Office Action.
Status of the Application
Receipt is acknowledged of Applicant's claimed invention, filed 13 May 2026, in the matter of Application N° 18/687,258. Said documents have been entered on the record.
Claims 1, 6, 16-17, 28, 63, and 92 have been amended. Claims 2-4, 64 and 66 are canceled. No new matter was introduced.
Thus, Claims 1, 6, 11, 16-18, 20-24, 28, 63, 73, 78, 80-81 and 92 represent all claims currently under consideration.
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.
Claims 28 and 92 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.
Claim 28 recites “greater than 1:1 brain to plasma ratio of said DHA administered to said periorbital skin or eyelid of said subject is delivered to a brain of said subject.” However, it is unclear what parameter is being compared to determine the recited brain-to-plasma ratio. For example, the claim does not specify whether the ratio is based on concentration, maximum concentration (Cmax), area under the curve (AUC), steady state concentration, or another measurement. Accordingly, one of ordinary skill in the art would not be reasonably apprised of the metes or bounds of the claim.
Further, the phrase “where a greater than 1 brain to plasma ratio is generally considered high efficiency brain delivery” is a subjective characterization that fails to provide an objective standard for determining claim scope. Therefore, the metes and bounds of the claimed invention are not reasonably certain.
Claim 92 recites that the pharmaceutical composition “further comprises greater than 3000 mg of said DHA.” However, Claim 63, from which Claim 92 depends, already recites a pharmaceutical composition “comprising DHA and one or more emollients.” Therefore, it is unclear whether Claim 92 is intended to require a total amount of DHA greater than 3000 mg in the pharmaceutical composition or an additional amount of DHA beyond the DHA already recited in Claim 63. As such, the scope of the claimed subject matter is not reasonably certain.
Moreover, even if Claim 92 is interpreted as requiring greater than 3000 mg of DHA, the claim fails to specify the reference basis for the recited amount of DHA. For example, it is unclear whether the recited amount refers to the amount of DHA present in a unit dose, a container, a package, a batch, or another quantity of the pharmaceutical composition. Accordingly, one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6, 11, 16, 18, 20-24, 63, 73, 78, 80-81 and 92 are rejected under 35 U.S.C. 103 as being unpatentable over Rosen (US 10,166,267 Bl, cited in IDS) and further in view of Wei (US 2012/0128754 A1, of previous record.)
Regarding Claims 1, 6, and 63, Rosen teaches method of preventing, delaying, or treating cognitive decline in a human or animal patient in need thereof, including Alzheimer's disease, and/or other neurodegenerative diseases, comprising administering a topical multi-component formulation containing up to 95% by weight of a nutritional component, such as DHA (‘267, Col 6, Lines 48-52, Col 11, Lines 27-31, and Col 38, Claim 8).
Regarding Claims 11 and 73, Rosen teaches a combination of omega-3 fatty acid and vitamin E (‘267, Col 6, Lines 59-64.)
Regarding Claim 16, Rosen exemplifies a composition comprising 500 mg DHA (‘267, Col 17, Line 29, Example 1.)
Regarding Claims 18 and 78, Rosen teaches the composition may be formulated to be administered by way of a cream, emulsion, or eyedrops and may be administered with other compounds, excipients, fillers, binders, carriers or other vehicles (‘267, Col 11, Lines 34-41.)
Regarding Claim 23, Rosen teaches a formulation for the treatment, delay, and/or prevention of cognitive decline, including Alzheimer's disease, and/or other neurodegenerative diseases (‘267, Abstract, Col 5, Lines 39-49.)
Regarding Claim 24, Rosen teaches a daily dosage of the composition (‘267, Col 17, Line 34, Example 1.)
Regarding Claim 92, Rosen teaches 500 mg/kg DHA. With an average human weight of 62 Kg, this would equate to a composition dose of 31,000 mg (‘267, Col 17, Line 38.)
While Rosen teaches methods of promoting health and preventing and/or treating neurodegenerative disorders through administration of DHA-containing pharmaceutical compositions, including topical dosage forms, Rosen does not expressly teach administration of the composition to the periorbital skin or eyelid of a subject.
However, Wei teaches topical administration of active agents to the external surface of the eyelid and specifically teaches application to the closed eyelid (‘754, Pg. 1, Para 0002.) Wei further explains that the eyelid contains sensory receptors and neural pathways associated with branches of the trigeminal nerve, which project to the brainstem (‘754, Pg. 3, Para 0050-0051.) Thus, Wei teaches that the eyelid is a physiologically active and therapeutically relevant administration site rather than merely a cosmetic surface.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to administer the DHA-containing compositions of Rosen to the eyelid as taught by Wei because Wei identifies the eyelid as a recognized therapeutic administration site for topical delivery of active agents and teaches advantages associated with that route of administration. A person of ordinary skill in the art would have been motivated to utilize the known eyelid administration technique taught by Wei for administration of Rosen’s DHA-containing compositions, with a reasonable expectation of successfully delivering the active agent by a known topical administration route while obtaining the recognized advantages associated with eyelid administration.
Regarding Claim 20, Wei teaches topical administration of compositions to the eyelid and further teaches that such compositions may comprise suitable preservatives, including sorbic acid, edetate sodium, and thimerosal (‘754, Pg. 5, Para 0083.) It would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate a preservative into the DHA-containing composition of Rosen because preservatives were conventionally employed in pharmaceutical formulations to improve stability and shelf life and Wei expressly teaches such preservative-containing eyelid-administered formulations.
Regarding Claim 21, Wei teaches topical administration of compositions to the eyelid and further teaches that ideally, the formulated product is free of preservatives (‘754, Pg. 4, Para 0061.) It would have been obvious to one of ordinary skill in the art at the time of the invention to formulate the DHA-containing composition of Rosen without preservatives because preservative-free formulations were recognized alternatives in the pharmaceutical arts and Wei expressly identifies preservative-free formulations as desirable embodiments for eyelid-administered compositions.
Regarding Claim 22, Wei teaches topical administration of compositions to the eyelid and further teaches administration using wipes, pads, towelettes carrying the active composition, including single-use packaged applicators for delivery of the composition to the eyelid (‘754, Pg. 2, Para 0032.) It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the composition using conventional topical application devices and applicators, including wipes, pads, bottles, applicator tools, or a user’s fingertip, because such devices represent well-known and predictable mechanisms for applying topical compositions to the eyelid and periocular region.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Rosen and Wei as applied to Claims 1, 6, 11, 16, 18, 20-24, 63, 73, 78, 80-81 and 92 above, and further in view of Burattin (US 2021/0290578 A1, cited in IDS).
As discussed above, the combination of Rosen and Wei teaches or suggests administration of DHA-containing topical pharmaceutical compositions to the eyelid for promoting health and preventing and/or treating neurodegenerative disorders.
Rosen and Wei, however, do not expressly teach administration of DHA in an amount of 5-200 mg per eye, as recited in Claim 17.
However, Burattin teaches ophthalmic fatty-acid compositions comprising DHA, wherein DHA may comprise from about 0.5% to about 15% of the composition (‘578, Pg. 7, Example 1, Para 0154) and wherein the composition may be administered in amounts ranging from about 0.1-50 mg/kg (‘578, Pg. 7, Para 0150). With an average human weight of 62 Kg, this would equate to 6.2-3100 mg total, with the DHA percentage ranging from 0.93-465 mg. In view of the dosage teachings of Rosen/Wei and Burattin, it would have been prima facie obvious to one of ordinary skill in the art to select an amount of DHA within the claimed range of 5-200 mg per eye, as determination of an effective amount of a known therapeutic agent constitutes routine optimization of a result-effective variable. The claimed amount represents no more than the selection of a workable dose from among the finite number of predictable dosage amounts suggested by the prior art. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP § 2144.05.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627
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