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 .
Status
Applicant’s response dated 21 October 2025 to the previous Office action dated 22 July 2025 is acknowledged. Claims 22 and 24 are pending in the application.
The rejection under 35 U.S.C. 112 made in the previous Office action is maintained.
The rejection under 35 U.S.C. 103 made in the previous Office action is maintained.
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.
Claim 24 is 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.
Claim 24 recites that the composition does not comprise feverfew or feverfew extract, but the specification as filed fails to recite such a negative limitation, and a skilled artisan would not have understood that such a negative limitation is necessarily present in the disclosure as filed. See MPEP 2173.05(i) (“Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement.”).
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.
Claim(s) 22 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siber (US 2004/0235047 A1; published 25 November 2004; of record) in view of Snyder et al. (US 2007/0184013 A1; published 09 August 2007; of record) and Honcharuk et al. (UA 106737 C2; published 10 October 2014; of record).
Siber discloses compositions and methods for treatment of SARS (title) including SARS-associated coronavirus (SARS-CoV) infection (abstract) wherein compositions include an antibiotic agent such as tetracyclines (paragraph [0128]) wherein compositions include an anti-viral compound (paragraph [0115]) such as propolis (paragraph [0118]) wherein a method for treating a patient having SARS comprises administering to the patient a therapeutically effective amount of active agents (paragraphs [0018]-[0019], [0030]-[0031], [0043]).
Siber does not disclose calendula or Echinacea sp. tincture as claimed.
Snyder et al. discloses an antiviral method (title) against enveloped viruses (paragraph [0020]) such as SARS-CoV (paragraph [0003]) wherein antiviral agents include botanicals such as calendula oil (paragraph [0062]).
Honcharuk et al. discloses administration of tincture of Echinacea for respiratory viral infections (abstract) such as SARS (page 4 first paragraph).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Siber, Snyder et al., and Honcharuk et al. by including in the composition and method of Siber as discussed above, calendula oil as in Snyder et al. and tincture of Echinacea as in Honcharuk et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to more effectively treat SARS because the compositions and methods of Siber, Snyder et al., and Honcharuk et al. are all directed to treating SARS, and it is prima facie obvious to combine compositions each of which is taught by the prior art to be useful for the same purpose, per MPEP 2144.06(I).
Although Siber discloses SARS-CoV, Siber does not specifically disclose such as SARS-CoV-2, or COVID 19. However, since there are only 2 species within the genus of SARS-CoV, and since they both cause severe acute respiratory syndrome (i.e., SARS), and since the method and composition of Siber are specifically directed to SARS-CoV, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the method and composition of Siber, and thus Siber in view of Snyder et al. and Honcharuk et al. as discussed above, to treat SARS-CoV-2, or COVID 19, with a reasonable expectation of success.
Regarding claim 24, the methods and compositions of Siber, Snyder et al., and Honcharuk et al. do not include feverfew or feverfew extract.
Response to Arguments
Applicant's arguments filed 21 October 2025 have been fully considered but they are not persuasive.
Applicant argues that claim 24 is supported in the specification as originally filed at page 9 beginning at line 30 which states, “Alternatively or additionally, various exemplary embodiments of the invention exclude any specific feature, part, component, module, process or element which is not specifically disclosed herein.” (remarks page 2). In response, such a broad, open-ended exclusion of every possible non-disclosed component does not constitute a written description of every possible non-disclosed species because it would not reasonably lead those skilled in the art to any particular species. See, e.g., MPEP 2163.05(II) which cites Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety for every possible position does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species).
Applicant argues that with respect to Siber there is no evidence in the record that in late April 2020 the skilled artisan would have any expectation that a treatment for SARS-CoV would be useful for treating COVID 19 (remarks page 3). In response, Siber discloses compositions and methods for treatment of SARS (title) including SARS-associated coronavirus (SARS-CoV) infection (abstract), and since there are only 2 species within the genus of SARS-CoV, and since they both cause severe acute respiratory syndrome (i.e., SARS), and since the method and composition of Siber are specifically directed to SARS-CoV, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the method and composition of Siber, and thus Siber in view of Snyder et al. and Honcharuk et al. as discussed above, to treat SARS-CoV-2, or COVID 19, with a reasonable expectation of success.
Applicant argues that Siber mentions propolis and tetracycline in separate paragraphs but does not teach a combination thereof (remarks pages 3-4). In response, Siber teaches that for purposes of treatment of SARS (title) including SARS-associated coronavirus (SARS-CoV) infection (abstract) compositions include an antibiotic agent such as tetracyclines (paragraph [0128]) and that compositions include an anti-viral compound (paragraph [0115]) such as propolis (paragraph [0118]), and it is prima facie obvious to combine compositions each of which is taught by the prior art to be useful for the same purpose, per MPEP 2144.06(I).
Applicant argues that to establish obviousness the prior art must clearly and unequivocally disclose the claimed invention without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference, per In re Arckley, 455 F.2d 586, 587 (C.C.P.A. 1972) (remarks page 4). In response, In re Arckley specifically states that such standard applies to anticipation rather than obviousness, and specifically states that such picking and choosing may be entirely proper in an obviousness rejection. Id.
Applicant argues that a mere naming of compounds in a list, without additional motivation, suggestion, or teaching for specific combinations, is insufficient to make the combination obvious (remarks page 5). In response, Siber discloses such compounds are used for treating SARS including SARS-CoV, and it is prima facie obvious to combine compositions each of which is taught by the prior art to be useful for the same purpose, per MPEP 2144.06(I).
Applicant argues that selecting a specific combination form a range of possibilities is not obvious unless there is a clear teaching, suggestion, or rationale in the prior art that would lead a person of ordinary skill to that specific combination (remarks page 5). In response, Siber discloses such compounds are used for treating SARS including SARS-CoV, which provides clear teachings of the prior art, and it is prima facie obvious to combine compositions each of which is taught by the prior art to be useful for the same purpose, per MPEP 2144.06(I), which provides the rationale for the combination.
Applicant argues that Siber has too many potential combinations of compounds for there to be a reasonable expectation of success that every combination would have the desired activity (remarks page 5). In response, any combination of compositions each of which is taught by the prior art to be useful for the same purpose is prima facie obvious per MPEP 2144.06(I).
Applicant argues that Siber lacks experimental data and therefore there is a lack of a reasonable expectation of success (remarks page 5). In response, a reference need not provide experimental data or proof of efficacy to make a prima facie case, per MPEP 2121(III).
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617