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
Applicant's election with traverse of Group II, claims 16-29 in the reply filed on 7/21/2025 remains acknowledged.
Applicant's election with traverse of:
(iii) resveratrol (formula (IA));
(iv) vitamin D3;
(v) nasal spray;
(vi-a) preventing an acute respiratory distress syndrome;
(vii) from 2.0 mg to 20 mg per day of the resveratrol (claim 28);
(viii) from 1,500 IE (sic, construed to be IU, as in Table I) to 10,000 IE (sic, IU) per day,
in the reply filed on 7/21/2025 remains acknowledged.
Claims 25, 27-38 have been canceled.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. EP20169221, filed 4/10/2020, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The Examiner’s review of the EP priority document failed to identify the instant claimed locally administered to the respiratory system of independent claim 16, and no identification of administration with Applicant elected nasal sprays (claims 18, 19). For instance, in Example 1 of the specification, the mouse models involved injection of Vitamin D and oral dosing in food of resveratrol (i.e., neither involves inhalation). Thus, the effective filing date of examined claims is the filing date of the PCT, 3/19/2021.
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.
Claim(s) 16-20, 22-26, 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beyond the Mountain Wellness (“Ways to Protect Yourself From Coronavirus COVID-19”; 2020 Apr 2; https://beyondthemountainwellness.com/blog/2020/4/2/ways-to-protect-yourself-from-coronavirus-covid-19#:~:text=These%20choices%20include%20supplementation%2C%20supporting,causing%20a%20decreased%20immune%20response.; IDS reference); in view of Weston et al. (US 5,497,944 A; 1996; IDS reference); Moretti, et al. (EP 2 674 155 A1; 2013; IDS reference).
The webpage from Beyond the Mountain Wellness teaches there are many natural things we can do from home to protect ourselves from getting Coronavirus (COVID-19); these include, inter alia, supplementation. Top section. The first six supplements that boost immunity, show them very helpful for preventing the harmful symptoms of COVID-19. These include Vitamin D, at doses of 2000-6000 IU a day, these overlap with claim 16 range, rendering the claimed range of vitamin D prima facie obvious. The five additional supplements discussed next include resveratrol, at dose of 150-500 mg per day. In the Resveratrol section Resveratrol is a broad antioxidant and engages in cell-signaling activities, and potentially has antiviral properties, protecting yourself from viruses.
The Supporting Healthy Digestion section indicates that the cytokine storms created by COVID-19 is mostly inflammation in the lungs, as once consideration of COVID-19 infection.
This webpage establishes one preventative combination corresponds to resveratrol and vitamin D to protect ourselves from getting Coronavirus (COVID-19).
This webpage does not teach local administration to the respiratory system or by inhalation or by nasal sprays.
Weston teaches a metered dose inhaler for dispensing a fluid medicament as droplets of small mean particle size without the use of pressurized gas or liquified propellants; a liquid drug is contained in a fluid reservoir and metered quantities of the drug are successively presented into a reduced cross-section pressure chamber, with non-return valves controlling the flow of liquid through the device. The metered quantity of the drug is then subjected to a sudden and great increase in pressure by releasing a piston into the pressure chamber. The liquid drug is thereby ejected through an atomizing head to reduce it to a fine spray of small mean particle size, preferably less than approximately 12 micrometers (abstract).
The present invention relates to atomizing devices and methods, notably to self-contained hand-held devices for dispensing a fluid medicament, and methods for administering fluid droplets to a locus, notably medicaments to the nasal passages or lungs. Weston establishes a metered dose inhaler that delivers fluid medicaments to nasal passages (i.e., administration via Applicant elected nasal sprays). Considering the seriousness of cytokine storms and inflammation in the lungs, the skilled artisan would have reasonably expected local delivery to the respiratory system of the resveratrol and vitamin D to have direct benefit to the lungs.
Moretti teaches that resveratrol has been associated with carboxymethylglucan with the purpose of increasing the solubility in aqueous solution and the consequent bioavailability of resveratrol; these are useful for preparing pharmaceutical compositions, in liquid formulation, with antioxidant, anti-inflammatory and antiviral properties, among those listed (abstract). Concentrations of resveratrol in solution is the range from 0.003% to 10% in weight in aqueous solution [0011] (substantially overlapping with range of claim 23-24, rendering these ranges obvious. The solubilization of resveratrol allows using a lower quantity of this molecule in the production of liquid formulations of pharmaceutical specialty; the greater solubility and stability of resveratrol allows better bioavailability; possible synergetic effects already known between resveratrol and other molecules is strengthened [0017]. Examiner notes that these concentrations are very similar to those of the instant disclosure on p. 14, and of claims 23-24. When optimizing dose for local inhalation delivery, similar amounts to those disclosed on p. 14 would have been obvious to determine as a result of routine optimization of doses.
Considering Weston and Moretti, it would have been obvious to dose both the resveratrol and vitamin D to a patient vial local delivery to the respiratory system, including via nasal spray delivery.
The efficacy of formulating resveratrol with carboxymethylglucan and resultant improvement of bioavailability suggests reduction in dose from the range taught by Beyond the Mountain Wellness, and doses in the range of claim 28 would have been obvious as a result of these improvements, to be ultimately determined via routine optimization. The doses of vitamin D overlap with the ranges of instant claims 25, 28, rendering the doses prima facie obvious.
The mechanism of claim 22 is construed to be characteristic of the same method of claim 16 that is obvious. Examiner notes that Chang et al. (“Resveratrol inhibits NLRP3 inflammasome activation by preserving mitochondrial integrity and augmenting autophagy”; 2014; Journal of Cellular Physiology; Vol 230; Issue 7; httop://doi.org/10.1002/jcp.24903; IDS reference) also teaches this specific mechanism in inflammatory disease, consisting with the position that this mechanism is inherent to this obvious method.
Regarding claim 26, dosing two drugs, each via inhalation to the nasal passage renders sequential administration of claim 26 as obvious.
Applicant disagrees with the characterizations of Beyond the Mountain, Weston and Moretti, but does not specifically point out any supposed errors.
Regarding the combination of resveratrol and vitamin D, as a combination, both of these are taught to potentially be of benefit in treatment/prevention of COVID-19, rendering their combination prima facie obvious, from the individual teachings of each of these active compounds. Per MPEP 2144.06 (I)< "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)
Regarding administration by inhalation, this technique is clearly taught by Weston, and renders this aspect of the instant method as obvious.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beyond the Mountain Wellness (“Ways to Protect Yourself From Coronavirus COVID-19”; 2020 Apr 2; https://beyondthemountainwellness.com/blog/2020/4/2/ways-to-protect-yourself-from-coronavirus-covid-19#:~:text=These%20choices%20include%20supplementation%2C%20supporting,causing%20a%20decreased%20immune%20response.; IDS reference); in view of Weston et al. (US 5,497,944 A; 1996; IDS reference); Moretti, et al. (EP 2 674 155 A1; 2013; IDS reference) as applied to claims 16-20, 23-26, 28 above, and further in view of Grant et al. (“Evidence that Vitamin D Supplementation Could Reduce Risk of Influenza and COVID-19 Infections and Deaths”; 2020 Apr 2; Nutrients 12, 988; doi:10.3390/nul2040988; IDS reference).
The teachings of Beyond the Mountain Wellness, Weston and Moretti are set forth above, together with reasons the method of claim 16 is obvious. Regarding claim 21, these references do not teach that the vitamin D is Vitamin D3. Grant discussed considerations of COVID and the benefit of vitamin D in reducing the risk of respiratory tract infections, and how vitamin D supplementation might be a useful measure to reduce risk. To reduce the risk of infection it is recommended that people at risk of influenza and/or COVID-19 consider taking 10,000 IU/d of vitamin D3 for a few weeks to raise 25(OH)D levels, followed by 5000 IU/d. Grant establishes vitamin D3 is a preferable form of Vitamin D for prevention (reduction of risk) of COVID-19 infection. Thus, it would have been obvious to utilize this Vitamin D3 form of vitamin D in carrying out the obvious method, where resveratrol and Vitamin D3 are locally administered to the respiratory system, giving the method of claim 21. The reason is the preference for this compound in treating/preventing COVID-19.
Applicant argues about dose of resveratrol, and dose of vitamin D. The dose range of vitamin D taught overlaps with claim 16 dose, rendering the claimed dose prima facie obvious. MPEP 2144.05 (I): 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding the amount of resveratrol of claim 16, confusingly, this dose does not agree with dependent claim 23-24, in terms of concentration. The obvious concentrations from the art applied is similar to disclosed concentration ranges (these concentrations are very similar to those of the instant disclosure on p. 14, and of claims 23-24). Optimization to actual mg amounts would have been obvious. For administration to the respiratory system using similar or the same concentrations would have resulted in the same or similar amounts per day, as a result of routine optimization, i.e., giving the doses of claim 16, which are also in the disclosure on p. 14. Thus, the claimed doses are obvious as a result of routine optimization of dosing, and also likely close to those of claim 16.
Conclusion
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614
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