DETAILED ACTION
This office action is in response to the Applicant’s filing dated June 7th, 2024.
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 is a 371 of PCT/US2022/014267 filed on February 23rd, 2022; and has a PRO of 63142598 filed on January 28th, 2021.
Status of Claims
Claims 1-2, 8-12, 15, 17-18, 20-25, 32, 34 and 54-55 are pending in the instant application. Acknowledgement is made of Applicant’s remarks and amendments filed on June 7th, 2024. Acknowledgment is made of Applicant’s amendment of claims 1, 8-12, 15, 17, 20-22, 24-25, 32 and 34; the cancelation of claims 3-7, 13-14, 16, 19, 26-31, 33 and 35-53; and the addition of new claims 54-55.
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.
Claims 1-2, 8-12, 15, 17-18, 20-25, 32, 34 and 54-55 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (US 2020/0289534 A1), cited in the Applicant’s IDS filed on December 7th, 2023; as evidenced by Kim (https://orthomolecular.org/resources/omns/kor/v16n22-kor.pdf : 05 April 2020 – Google Machine Translation obtained 03/13/2026), cited for evidentiary purposes only; as further evidenced by Rowe et al (Handbook of Pharmaceutical Excipients, (2009), 6th Edition, Pharmaceutical Press, 637-640), cited for evidentiary purposes only.
Regarding claims 1, 8-11, 15, 17-18, 20-24 and 34, Peyman teaches Example 9 (page 59, paragraphs [0707-0708]) wherein a 70-year-old human female presented with running nose and cough lasting 2 days in duration. The patient’s COVID-19 culture came back positive for SARS-CoV-2 infection, and she was treated with a combination of Remdesivir and a Wnt inhibitor dissolved in a semi-fluorinated alkane administered 4 times; the treatment duration was 3 weeks and lasted until the patient made a recovery (page 59, paragraph [0707]). Peyman further teaches that sulforaphane is a Wnt inhibitor (page 40, paragraph [0503]), and that the antiviral therapy can be administered intravenously diluted in 0.9% NaCl, orally or intramuscularly (page 39, paragraph [0498]; pages 56-57, paragraph [0693]). Peyman teaches that this formulation can be used as a vaccine administered every 3-6 months to prevent re-infection by SARS-CoV-2 (page 59, paragraph [0705]).
Kim, cited for evidentiary purposes only, discloses sulforaphane is an anti-inflammatory agent that can alleviate inflammatory damage to the lungs, and possesses antiviral properties (page 1, paragraphs 1-2).
Rowe et al, cited for evidentiary purposes only, discloses that NaCl reads on a pharmaceutically acceptable diluent and excipient (page 637, Applications in Pharmaceutical Formulation or Technology).
Peyman does not explicitly name sulforaphane as the Wnt inhibitor used in combination with remdesivir to treat COVID-19 caused by SARS-CoV-2 infection.
It would have been prima facie obvious to a person of ordinary skill in the art to select sulforaphane as the Wnt inhibitor in the antiviral treatment regimen taught by Peyman. Peyman teaches treating SARS-CoV-2 infection using a combination therapy composition comprising Remdesivir and a Wnt inhibitor, and further teaches that sulforaphane is a Wnt inhibitor. Kim, cited for evidentiary purposes only, teaches that sulforaphane possesses antiviral properties capable of alleviating inflammatory damage to the lungs, which would have been desirable in the treatment of SARS-CoV-2 infection. A person of ordinary skill in the art would have been motivated to administer sulforaphane as the Wnt inhibitor in Peyman’s method in order to provide antiviral and anti-inflammatory therapeutic benefits while inhibiting Wnt signaling during a SARS-CoV-2 infection. This would have represented the predictable use of a known compound having the desired Wnt-inhibitory and anti-viral properties within the same treatment method disclosed by Peyman, and one of ordinary skill in the art would have had a reasonable expectation of success in using sulforaphane together with Remdesivir to treat SARS CoV-2 infection. “[T]he rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Regarding claim 2, Peyman renders obvious the methods of claims 1, 8-11, 15, 17-18, 20-24 and 34 as described above. The prior art is silent regarding sulforaphane inhibiting viral replication of the coronavirus. However, sulforaphane inhibiting viral replication of the coronavirus will naturally flow from the teachings of (or method made obvious by) the prior art (see above rejection), since the same compound (sulforaphane) is being administered to the same subjects (patients with COVID-19 caused by SARS-CoV-2). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding sulforaphane inhibiting viral replication of the coronavirus, by practicing the method made obvious by the prior art: US 2020/0289534 A1, one will also be inhibiting viral replication of the coronavirus with sulforaphane, even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (inhibiting viral replication of the coronavirus with sulforaphane) of the method made obvious by the prior art (US 2020/0289534 A1).
MPEP § 2145 (II) states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
Regarding claim 12, Peyman renders obvious the methods of claims 1, 8-11, 15, 17-18, 20-24 and 34 as described above. Peyman teaches a dosage range of sulforaphane of 10-40mg when administered orally (page 37, paragraph [0470]). Sulforaphane has a molecular weight of 177.29
g
m
o
l
;
10
m
g
*
1000
177.29
g
m
o
l
=
56
µ
m
o
l
and
40
m
g
*
1000
177.29
g
m
o
l
=
226
µ
m
o
l
.
MPEP § 2144.05 states:
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). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Regarding claims 25, 32 and 54, Peyman renders obvious the methods of claims 1, 8-11, 15, 17-18, 20-24 and 34 as described above. The individual components of the kit, sulforaphane and remdesivir, are already known in the art and as taught by Peyman have been established as useful in the treatment of COVID-19, which is caused by SARS-CoV-2. It would have been obvious, in view of the prior art, to include them together in a kit for ease of use. The inclusion of instructions for use in a kit format constitutes a conventional packaging strategy routinely employed to improve compliance or clarify dosing. The claimed kit combines known drugs with known utility and routine labeling practices, without producing any new or unexpected functional relationship among components, and is therefore considered an obvious combination. “[W]here the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.” In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004).
Regarding claim 55, Peyman renders obvious the methods of claims 1, 8-11, 15, 17-18, 20-24 and 34 as described above. It would have been prima facie obvious to one of ordinary skill in the art to utilize the amount of Remdesivir and sulforaphane taught by Peyman as a starting point for optimizing the amounts of sulforaphane and Remdesivir utilized to treat COVID-19 caused by SARS-CoV-2 since Peyman teaches both are useful for treating COVID-19 caused by SARS-CoV-2 and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP § 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all of this would result in the methods of instant claims 1-2, 8-12, 15, 17-18, 20-25, 32, 34 and 54-55 with a reasonable expectation of success.
Conclusion
Claims 1-2, 8-12, 15, 17-18, 20-25, 32, 34 and 54-55 are rejected.
No claim is allowed.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691