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 02/09/2024 is a National Stage entry of PCT/HU2022/050060, International Filing Date: 08/08/2022. PCT/HU2022/050060 claims foreign priority to P2100293, filed 08/09/2021; and claims foreign priority to 21191707.5, filed 08/17/2021. Certified copies of the foreign priority applications are of record.
Status of Claims
Claims 11-18 are pending as of the response filed on 7/6/26. Applicant’s election without traverse of invention II, claims 11-17 in the reply filed on 7/6/26 is acknowledged.
Claim 18 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/6/26.
Claims 11-17 were examined. Claims 11-12, 14, and 16-17 are rejected. Claims 13 and 15 are objected to.
Claim Rejections-35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 14 depends directly from claim 11 and recites the compound is selected from “petasol and esters thereof, isopetasol and esters thereof”. However, “esters thereof” are considerably broader than the specific esters encompassed by claim 11 when R2 is of formula (i). As such, the subject matter of claim 14 is broader than claim 11. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
For the sake of compact prosecution, “petasol and esters thereof, isopetasol and esters thereof” have been interpreted by the examiner to encompass compounds wherein R2 is of formula (i) as defined by claim 11.
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, 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) 11-12, 14, and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drewe et. al., WO 2016156028 A1, publ. 10/6/2016, in view of Debrunner et. al., Pharmaceutica Acta Helvetiae, vol. 70, pp. 315-323, publ. 1995; and Singh et. al., Pharm. Rep., vol. 72, pp. 1479-1508, publ. 9/5/2020.
Drewe teaches extracts of Petasites for the treatment of viral infections (title & abstract; p. 1, lines 3-4). Drewe teaches extracts of the Petasites plant, containing active agents in physiologically effective forms and amounts (p. 1, lines 13-17; p. 2, lines 3-12). Drewe teaches the Petasites extract to be used for treatment is not limited to a particular Petasites species as substantially all Petasites plants contain qualitatively the same physiologically active ingredients; however, Petasites hybridus is included as a preferred species (p. 3, lines 22-30). It is further preferred that the extracts are used to treat a viral respiratory disease (p. 3, lines 31-32). Drewe teaches administration of therapeutically effective doses of the Petasites extract (p. 5, lines 13-24). Treatment of respiratory viral infections in a mammal is taught as a preferred embodiment (p. 6, line 32-p. 7, line 3). Drewe mentions isopetasine and petasine as compounds in Petasites extracts (p. 9, lines 20-26).
Treatment of a coronavirus infection, and compounds of formula (III) are not explicitly taught or suggested in Drewe.
Debrunner teaches Petasites hybridus contains numerous compounds that are of pharmaceutical interest (abstract; p. 315, 1st para of Intro). Debrunner teaches P. hybridus extracts contain the following main eremophilane esters (p. 315, right col., last para-p. 316, Table 1 & left col., top 3 lines of para):
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. Compounds (1)-(6) are included within formula (III) of the instant claims, having: R1=isopropyl, and the ring carbon to which it is attached is a double bond (compounds (1) & (4)); R1=isopropenyl wherein the bond between R1 and carbon 3 is a single bond (compounds (2), (3), (5), (6)); R2= formula (i), wherein R4=butenyl (compounds (1), (2), (3)), and wherein R4=thioalkyl (compounds (4), (5), (6)). Compounds (2) and (3) meet the limitation of an ester of petasol as recited by instant claim 14, as R1=isopropenyl, and R2 is an ester as defined by formula (i).
Debrunner doesn’t teach or suggest treatment of a coronavirus infection.
Singh teaches that as of 9/5/2020, there were no treatment options available for treatment of COVID-19, a deadly, contagious disease, and that there was focus on repurposing known drugs for efficacy against the virus (abstract). Singh teaches COVID-19 as severe acute respiratory syndrome coronavirus 2, which spreads primarily through the respiratory tract, entering cells via the ACE2 receptor (p. 1479, beginning with Intro-p. 1480, right col., para before COVID-19 pandemic). Singh teaches there is an urgent need to discover effective therapeutics towards COVID-19, and repurposing already available drugs, particularly existing antiviral drugs, is a desirable strategy associated with lower costs (pp. 1479-1480, 1st para of Intro).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have treated a coronavirus infection, such as COVID-19, by administering to a subject in need thereof an extract of P. hybridus containing isopetasin, neopetasin, petasin, iso-S-petasin, neo-S-petasin, and S-petasin, in consideration of the combined teachings of Drewe, Debrunner, and Singh. Drewe teaches administering an extract of P. hybridus for treating viral infections, particularly respiratory viral infections. Although Drewe doesn’t explicitly teach the extract to contain a compound of formula (III), Debrunner teaches P. hybridus to contain isopetasin, neopetasin, petasin, iso-S-petasin, neo-S-petasin, and S-petasin, all included within formula (III). Additionally, Singh teaches due to the urgency of the COVID-19 pandemic, there was interest in repurposing known drugs, particularly antivirals, for treating COVID-19 infections. As Drewe teaches treatment of viral respiratory infections by administering an extract of P. hybridus, one of ordinary skill in the art would have been motivated to have administered to a subject in need thereof an extract of P. hybridus, containing isopetasin, neopetasin, petasin, iso-S-petasin, neo-S-petasin, and S-petasin, for the treatment of a COVID-19 infection, in view of the urgency for such treatments and the repurposing of known antivirals for treating COVID-19, and have had a reasonable expectation of success.
Regarding instant claim 12, wherein the compound is the S-isomer, a prima facie case of obviousness exists for compounds highly similar in structure. See MPEP 2144.09 (I): A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990). Therefore, administration of an S-isomer of a compound of formula (III) present in an extract of P. hybridus, to treat a coronavirus infection would have been prima facie obvious, in the absence of unexpected results.
Claim Objections
Claims 13 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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