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 .
Claims status:
Claims 22-37 are pending
Claims 22-30 and 34-37 are examined
31-33 remain withdrawn
Summary of rejection from CTNF on 9/24/25
112b rejections over claims 28-30 are withdrawn due to applicant’s claim amendments on 12/4/25.
Double patenting rejection over claims 22-30 and 34-37 remain due to the disapproval of applicant’s terminal disclaimer on 12/11/25.
103 rejection is withdrawn/edited in view of applicant’s claim amendments on 12/4/25.
New Grounds of rejections based on applicant’s new claim amendments filed on 12/4/25. Applicant’s arguments presented on 12/4/25 are moot due to new grounds of rejection.
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 22-30 and 34-37 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.
In the claims filed on 12/4/25, applicant narrowed the claims by adding the following limitation: “or any anti-SARS-CoV-2 effect”
Applicant alleges support for said limitation appearing in page 10 of the specification at lines 4-9. However, a review shows only support for “or any effects against the infection by SARS-Cov-2 itself”.
The removal of “infection” is a material change. The specification is limited to no effects against the infection of SARS-CoV-2 while the claim is no effects to any SARS-CoV-2 infection.
SARs-COV-2 disease is a multiphasic disease, affecting multiple organ systems, such as 1) viral infection and replication, 2) imbalanced immune response as cytokine storm, and 3) ARDS associated systemic hypoxia and vascular/endothelial dysfunction associated pathologies. (See paragraph 0080 of Singh et al. US 2022/0193181 A1). Infection is only one phase of impacts. Applicant’s current claim amendments is broader than having no effect on the infection of SARS-CoV-2 itself. It covers having no effect on other non-infection impacts/effects. Thus, the current amendment is considered new matter as it broadens the impact of the peroral composition on SARs-CoV-2.
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.
Claim 22-30 and 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over Gianni et al. “Supplementary management with Pycnogenol….” published June 4, 2020 in view of Varga et al “Endothelial cell infection and endotheliitis in Covid-19 published April 17, 2020 and Bezerra et al. “Pycnogenol uses in the prevention and treatment of cardiopathies” published 2019.
Examiner notes: Applicants specification discloses Pycnogenol as the peroral composition of the instant invention. It is generally understood that Pycnogenol is between 65-75% procyanidins and the balance being a pharmaceutically acceptable excipient (from applicant’s specification.
Regarding 22-30 and 34-37, Gianni teaches identifying patients recovering from covid-19 and in a post-covid-19 recovery state and providing them with oral peroral composition comprising 150 mg/day Pycnogenol (extract of pine bark) to treat a broad spectrum of diseases and impairments (specifically Lung disease). (See abstract and conclusion). Implicitly, since both Gianni and applicant use the same pine bark extract it would be expected to not have an anti-viral or anti-sars effect.
With respect to claims 22-30 and 34-37 Gianni does not expressly teach applying to subjects with endothelial inflammation as a result of their covid infection.
However, Varga teaches that endothelial infection/inflammation and disease is a result of Covid-19 infection. (See pages 1417 and 1418).
Additionally, its is also widely known that Pycnogenol is useful in treating endothelial inflammation and even lung injury. (See Bezerra at page 46 left column table 1 and 1st paragraph and page 45 left colun 2nd paragraph teaching Pyc oral pills).
It would have been obvious to combine the teachings of Gianni and Varga/Bezerra for applying Pycnogenol to post covid patients to treat many effects from Covid including lung disease, endothelial inflammation and other known impairments that Pycnogenol was known to be effective for.
With respect to claims 28-30, the limitation of the endothelial blood flow and microcirculation function troubles including endothelial dysfunction related blood pressure troubles and endothelial dysfunction blood velocity troubles would have been obvious over the endothelial dysfunction including increased vasoconstriction with reduced vasodilatation (paragraph spanning 1417-1418), as taught by Varga and Bezerra’s teaching of platelet adhesion (page 46 left column second fullparagraph). One of ordinary skill in the art would have known that increased vasoconstriction with reduced vasodilatation are related to blood pressure, blood velocity problems, and thrombosis.
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 22-30 and 34-37 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 17-30 of copending Application No. 17/928,797 (the ‘797 Application) in view of Gianni et al. “Supplementary management with Pycnogenol….” published June 4, 2020.
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method of treating endothelial inflammation and/or endothelial systemic dysfunction triggered by Corona virus disease 2019 (COVID-19) induced by Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) infection in a symptomatic post-COVID-19 subject in need thereof, comprising administering to the subject a peroral composition comprising a source of δ-(3,4-dihydroxyphenyl)-γ-valerolactone, inter alia, and therefore, encompass overlapping and coextensive subject matter.
The difference is that instant claim 22 recites only δ-(3,4-dihydroxyphenyl)-γ-valerolactone as the constituent, whereas claim 17 of the ‘797 Application recites a Markush group of the constituents including δ-(3,4-dihydroxyphenyl)-γ-valerolactone. However, δ-(3,4-dihydroxyphenyl)-γ-valerolactone is included in the Markush group of constituents in instant claim 22 and renders obvious claim 17 of the ‘797 Application. Another difference is the inclusion of the current amendment of having no anti-SARS-CoV-2 effects. However, because both applications utilize the same peroral source the anti-viral and anti-SARS-CoV-2 effect is considered implicitly taught (additionally this limitation is an alternative limitation and not actually required). Gianni teaches that the peroral source is Pycnogenol as described in the 103 above and would have been an obvious choice for the peroral source.
Therefore, instant claims are obvious over claims of the ‘797 Application, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
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 AMJAD A ABRAHAM whose telephone number is (571)270-7058. The examiner can normally be reached Mon-Friday 830 AM to 500 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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AMJAD A. ABRAHAM
SPE AU 1663
Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663