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 .
Status of Application
The Remarks and Amendments filed on 11/12/25 are acknowledged.
Claims 2-10 and 13-14 were previously cancelled.
Claims 17-18, 21-23, and 26-27 were amended.
Claims 1, 11-12, and 15-30 are pending.
Claims 1, 11-12, and 15-16 were previously withdrawn from consideration.
Claims 17-30 are included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 10/17/25 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement.
Please see the attached copy of PTO-1449.
Response to Amendments & Arguments
Objection to the Specification
Applicant amended the Specification to remove the hyperlink and/or other form of browser-executable code on Pages 8 and 23. However, since Page 27, line 8 of the original specification dated 11/30/2022, now Page 26, line 22 of the Marked Up Specification dated 11/12/2025, still contains a hyperlink and/or other form of browser-executable code, the objection to the Specification is maintained.
Claim Objections
In light of the amendment of claims 17 and 21, the objections to these claims are withdrawn.
Claim Rejections – 35 USC § 112(b)
In light of the amendment of claims 18 and 21, the rejection of these claims under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
Claim Rejections – 35 USC § 103
Applicant’s arguments (Pages 7-10, filed 11/12/25) regarding the obviousness rejections listed below have been fully considered and are persuasive.
Rejection of claims 17-22 and 25-30 under 35 U.S.C. 103 as being unpatentable over Tokutake et al. (JP 2005-314316 A– English Translation - “Tokutake”) in view of Corder (US 10,285,970 B2)
Rejection of claims 23-24 under 35 U.S.C. 103 as being unpatentable over Tokutake in view of Corder and (Konno et al. (Tohoku J. Exp. Med., 2015, 237, 133-140 – “Konno”)
Applicant’s arguments regarding claim 17 directed to treatment of endothelial inflammation/dysfunction in symptomatic post-COVID-19 patients, which does not overlap in mechanism or patient population with Tokutake, were persuasive. Therefore, the obviousness rejections based on Tokutake as a primary reference are withdrawn.
However, upon further consideration, a new ground(s) of rejection is made over Gianni et al. (Biomed J Sci & Tech Res, June 04, 2020, pp. 21275-21280) in view of Varga et al. (Lancet. 2020 May 2;395(10234):1417-1418 – published online April 17, 2020) and Bezerra et al. (Rev Med UFC. 2019;59(3):44-47).
Since the new ground(s) of rejection were not necessitated by Applicant’s amendment, this action is made NON-FINAL.
Provisional Rejection - nonstatutory obviousness-type double patenting (NSDP)
Applicant’s arguments (Page 10, filed 11/12/25) regarding the provisional rejection of claims 17-30 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 22-37 of copending Application No. 17/347,879 (the ‘879 Application) have been fully considered and are persuasive. Since the ‘879 Application has a later patent term filing date (June 15, 2021) than the subject application (June 9, 2021), based on MPEP 804 (I)(B)(1)(b)(i), the NSDP rejection is withdrawn.
Applicant’s Request for Rejoinder
Applicant argues (Pages 10-11, filed 11/12/25) that no combination of Tokutake, Corder, and Konno teach or suggest that a composition comprising procyanidins could be used in 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, wherein the constituents of the composition do not exert anti-viral activity, as recited in amended claim 17 and withdrawn claims 1 and 15. Applicant argues that claims 1, 15, and 17, along with their dependent claims, share a special technical feature over the prior art in view of Tokutake, Corder, and Konno. Applicant requests rejoinder, examination, and allowance of the withdrawn claims upon allowance of the elected claims.
Although the obviousness rejection based on Tokutake, Corder, and Konno is withdrawn, a new ground of rejection based on Gianni, Varga, and Bezerra is set forth below. Based on the combination of Gianni, Varga, and Bezerra, the technical feature linking the inventions of groups I-III (as listed in the Lack of Unity (LOU) dated 04/03/25) does not constitute a special technical feature as defined by PCT Rule 13.2 as it does not define a contribution over the prior art. Therefore, the LOU is maintained.
Maintained Objection to the Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Please see Page 26, line 22, of the Marked Up Specification dated 11/12/2025, which still contains a hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. The objection to the Specification is maintained.
New Rejections
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
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 of this title, 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 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 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 17-30 are rejected under 35 U.S.C. 103 as being unpatentable over Gianni et al. (Biomed J Sci & Tech Res, June 04, 2020, pp. 21275-21280) in view of Varga et al. (Lancet. 2020 May 2;395(10234):1417-1418 – published online April 17, 2020) and Bezerra et al. (Rev Med UFC. 2019;59(3):44-47).
Instant claim 17 is 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 constituents selected from the group consisting of δ-(3,4-dihydroxyphenyl)-γ-valerolactone, δ-(3-Methoxy-4-hydroxy-phenyl)-γ-valerolactone, catechin, epicatechin, ferulic acid, gallic acid, 4-hydroxybenzoic acid, caffeic acid, protocatechuic acid, taxifolin and mixtures thereof, wherein said constituents mediate anti-inflammatory effects on the endothelium; and wherein said constituents do not exert anti-viral activity in the subject.
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) (Abstract and Conclusion).
The instant Specification discloses Pycnogenol® as the pine bark extract (original Specification - Page 8, lines 19-28) as the peroral composition of the instant invention (original Specification – Page 11, lines 20-30, original claims 17, 19, 26, and 27). It is generally understood that Pycnogenol® is between 65-75% procyanidins (original Specification – Page 19, lines 20-24) and the balance being a pharmaceutically acceptable excipient.
Implicitly, since both Gianni and applicant use the same pine bark extract, Pycnogenol®, it would be expected to not have an anti-viral or anti-SARS effect.
Gianni does not expressly teach administering Pycnogenol® to subjects with endothelial inflammation as a result of their COVID-19 infection.
Varga teaches that endothelial infection/inflammation and disease is a result of COVID-19 infection (Pages 1417-1418).
Bezerra teaches that Pycnogenol® (Pyc) is useful for endothelial function improvement (Page 46, Col. 1, Table 1, and 1st ¶) and inhibition of inflammatory cytokines producing during lung injury (Page 45, Col. 1, 2nd ¶). Pyc (200 mg/day) pills are also taught (Page 46, Col. 2, 2nd ¶).
It would have been obvious to combine the teachings of Gianni, Varga, and Bezerra for administering Pyc or pine bark extract to symptomatic post-COVID-19 subjects, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Gianni teaches administering oral peroral composition comprising 150 mg/day Pycnogenol® (extract of pine bark) to patients recovering from COVID-19 and in a post-COVID-19 recovery state. One of ordinary skill in the art would have had a reasonable expectation of success in treating a broad spectrum of diseases and impairments (specifically lung disease), as taught by Gianni (Abstract and Conclusion), as well as improving the endothelial inflammation in post-COVID-19 subjects, as taught by Varga since Bezerra teaches endothelial function improvement.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 17, the limitations of 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 would have been obvious over the administration of an oral peroral composition comprising 150 mg/day Pycnogenol® (extract of pine bark) to treat a broad spectrum of diseases and impairments (specifically lung disease) to patients recovering from COVID-19 and in a post-COVID-19 recovery state (Abstract and Conclusion), as taught by Gianni, in view of the endothelial infection/inflammation and disease which is a result of COVID-19 infection (Pages 1417-1418), as taught by Varga, and the use of Pycnogenol® (Pyc) for endothelial function improvement (Page 46, Col. 1, Table 1, and 1st ¶) and inhibition of inflammatory cytokines producing during lung injury (Page 45, Col. 1, 2nd ¶), as taught by Bezerra. Implicitly, since both Gianni and applicant use the same pine bark extract, Pycnogenol®, it would be expected to not have an anti-viral or anti-SARS effect.
Regarding instant claims 18, 21, and 22, the limitations of the endothelial systemic dysfunction of endothelial coagulation dysfunction would have been obvious over the endothelial dysfunction including increased vasoconstriction with reduced vasodilatation (¶ bridging Pages 1417-1418), as taught by Varga, and Bezerra’s teaching of platelet adhesion (Page 46, Col. 1, 2nd full ¶). 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.
Regarding instant claims 19-20, and 26-27, the limitations of the plant extract comprising from 20% to 95% w/w of procyanidins (instant claim 19), a plant extract comprising from 65% to 75% w/w of procyanidins (instant claim 20), extracts of pine bark (instant claim 26), and an extract of Pinus pinaster bark (instant claim 27) would have been obvious over the Pycnogenol® (extract of pine bark (Abstract and Conclusion), as taught by Gianni, which is the same Pycnogenol® disclosed in the instant Specification (original Specification - Page 8, lines 19-28), where Pycnogenol® has between 65-75% procyanidins (original Specification – Page 19, lines 20-24), and the Pycnogenol® bark extract from Pinus pinaster (Abstract), as taught by Bezerra.
Regarding instant claims 23 and 25, the limitation of endotheliitis would have been obvious over the endothelial cell infection and endotheliitis as a result of COVID-19 infection (Pages 1417-1418), as taught by Varga.
Regarding instant claim 24, the limitation of the vasculitis being a Kawasaki-like disease would have been obvious over the endothelial cell involvement across vascular beds of different organs in a series of patients with COVID-19 (Page 1417, Col. 1, 2nd ¶), the endothelial dysfunction which is a principal determinant of microvascular dysfunction by shifting the vascular equilibrium towards more vasoconstriction with subsequent organ ischaemia, inflammation with associated tissue oedema, and a pro-coagulant state (Page 1418, Col. 1, 1st ¶), as taught by Varga. One of ordinary skill in the art would have found the vascular inflammation or vasculitis that is a Kawasaki-like disease obvious over the vascular inflammation taught by Varga. A post-COVID-19 patient population having vascular inflammation as taught by Varga includes specific patients having vasculitis that is a Kawasaki-like disease.
Regarding instant claims 28-30, the limitations of the peroral composition further comprising a pharmaceutically excipient (instant claim 28), the form of a dietary supplement (instant claim 29), and a dosage from 25 mg per day to 300 mg per day (instant claim 30) would have been obvious over the Pyc (200 mg/day) pill taught by Bezerra (Page 46, Col. 2, 2nd ¶). One of ordinary skill in the art would have found it obvious that a pill containing Pyc will contain pharmaceutically acceptable excipients.
Conclusion
Due to the new grounds of rejection, this action is made non-final.
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615