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
Applicant’s response filed on September 26, 2025 to the Non-Final rejection mailed on May 8, 2025 is acknowledged.
The claims corresponding to the elected subject matter are 1-4, 8, 12-21 and are herein acted on the merits. Claims 5-7 are withdrawn.
Priority
This Application filed on 12/21/2021 is a 371 of PCT/IL2020/050663 filed on 06/16/2020 which has PRO 62/862,708 filed on 06/18/2019.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 7/7/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Response to Arguments
Applicant’s arguments over the 35 U.S.C. 103 rejection of claims 1-4, 8-9, 12-21 over Jha (WO2018145213) in view of Minatelli et al. (US 20140199342 A1) is not persuasive. The rejection is herewith maintained. Applicant argues, Jha does not teach the same conditions treated as those of the current invention. Furthermore, Applicant argues the conditions of Jha and Minatelli et al. are unrelated.
In response, the Examiner points out the claims are drawn to a composition and not a method of treatment, as argued. Additionally, the Jha and Minatelli are both related to formulations that are delivered through oral administration. The method of treatment is irrelevant to the claimed composition. The arguments are not persuasive.
The rejections are as below:
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 1-4, 8, 12-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jha (WO2018145213) in view of Minatelli et al. (US 20140199342 A1).
Jha teaches pharmaceutical formulation comprising: cannabidiol (CBD) present at 10-15 mg/ml and, one or more omega-3 fatty acids, comprising eicosahexaenoic acid (EPA) and/or docosahexaenoic acid (DHA) or pharmaceutically acceptable salts thereof, providing a combined concentration of EPA and/or DHA of 200-3000 mg/mL.
While the reference does comprise additional oils, the reference fails to specify Nannochloropsis, or a glycolipid, as recited in the claims.
Minatelli et al. teaches composition is formulated in a therapeutic amount to treat and alleviate symptoms of joint pain in a patient. The reference teaches algae based oil may be derived from the microalgae Nannochloropsis oculata comprising Eicosapentaenoic (EPA) fatty acids in the form of glycolipids and phospholipids. These omega-3 fatty acids, such as from an algae based oil, have greater bioavailability for cell growth and functioning as compared to the omega-3 triglycerides of fish oil. There are many varieties of algae that contain EPA conjugated with phospholipid and glycolipid polar lipids or contain EPA and DHA conjugated with phospholipids and glycolipids. Amounts of algae based oil are 1-4000 mg per daily dose. The reference teaches harvesting and drying the microalgae and producing a powder (see Example 5).
It would have been obvious to one of ordinary skill in the art to incorporate an algae based oil such as Nannochloropsis. The motivation to incorporate an algae based oil such as Nannochloropsis is because Minatelli teaches algae based oil, have greater bioavailability for cell growth and functioning as compared to the omega-3 triglycerides of fish oil. Therefore, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results. With respect to the amounts, to the skilled artisan, the claimed subject matter would have been obvious because the skilled artisan would have appreciated that certain factors would influence the dosage required to effectively treat the subject for the purpose taught by the references, including, but not limited to the severity of the disease or disorder, previous treatments, the weight, general health and/or age of the subject and the presence of other diseases. The dosage would thus have been expected to be variable and, in the absence of evidence to the contrary, the determination of the optimum dosage to employ would have been a matter well within the purview of the skilled artisan.
In claim 18, the recitation “used in the treatment of a disease or disorder selected from sleep disorder, insomnia, depression, anxiety, attention-deficit disorder, weight disorder (obesity, anorexia) and any combinations thereof,” are intended uses of the composition claim.
Conclusions
No claims are allowed.
The arguments are not persuasive and the rejection is made FINAL.
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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, James Henry Alstrum-Acevedo, can be reached on (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAYLA SOROUSH/Primary Examiner, Art Unit 1622