DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant's election with traverse of a method of preventing SARS-Cov-2 entry using FBA as the amide derivative of butyric acid in the reply filed on April 24, 2026 is acknowledged. The traversal is on the ground(s) that unity of invention exists and that the International Searching Authority found unity of invention. This argument has been considered, however, it is not found to be persuasive. It was set forth that the inventions listed do not relate to a single general inventive concept because the technical feature linking the inventions is not novel and unobvious. This argument still applies, especially in view of the prior art rejection in the office action. Thus, the claims are not linked by a single general inventive concept because the concept is taught in the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Priority
3. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
4. The information disclosure statements (dated October 11, 2023 and February 28, 2024) were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The statements were considered. Signed copies of form 1449 are enclosed herewith.
Claim Rejections - 35 USC § 112
5. Claims 1-3, 5, 7-11 rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the claims is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the compounds are butyric acid amide derivatives. However, the compounds named do not all contain a core structure of butyramide. For example,
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does not contain a common core.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 - considering objective evidence present in the application indicating obviousness or nonobviousness.
6. Claim(s) 1-3, 5, 7-11 and 13-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devaux et al. as applied to claims 1-3, 5, 7-11 and 13-21 above, and further in view of WO 2009130735.
Determining the scope and contents of the prior art
Devaux et al. teaches that the abundance of butyric acid bacteria is significantly decreased in COVID-19 patients, resulting in low butyrate. Further “the reduction of butyrate allows the expression of NRP-1, which likely contributes to SARS-CoV-2 infectivity of the GIT through binding to furin-cleaved substrates in the viral spike. The use o fbutyrate as a supportive treatment for COVID-19 has already been proposed. High intestinal lumen butyrate interacts with both GPR41 and GPR43. Its binding to GPR43 activates the G-proteins which stimulates phospholipase C (PLC) leading to generation of diacyglycerol (DAG) which activates protein kinase C (PKC) and inositol....therefore, butyrate supplementation to restore high intestinal butyrate levels could possibly reduc infectivity of intestinal epithelial cells with SARS-CoV2 and prevent autophagy.” Page 8.
WO2009130735 teaches butyrate as having a preventative effect on inflammation at the intestinal level. Page 2. The reference teaches the administration of prodrugs of butyric acid which can release butyric acid in the small and large intestine in a constant manner over time. Page 11. The reference teaches FBA (Applicant’s elected species) as one such prodrug, which is a preferred embodiment. Pages 12, 13.
Ascertaining the differences between the prior art and the claims at issue
The difference between Devaux et al. and the present claims to the elected species of preventing Covid-19 using FBA is that the reference teaches butyric acid vs. FBA which is an amide derivative to butyric acid.
Resolving the level of ordinary skill in the pertinent art and considering objective evidence present in the application indicating obviousness
MPEP 2143 B provides basic requirements of prima facie case of obviousness including examples of rationale of the simple substitution of one known element for another to obtain predictable results. To reject a claim based on this rationale the following is considered below and applied to the present claims:
A finding that the prior art method differs from claimed method by the substitution of some component with another component
Devaux et al. does not teach the administration of FBA. The prior art differs from the claims to the elected species by substitution of components, FBA for butyric acid.
A finding that the substituted components and their functions were known in the art
WO 2009130735 teaches prodrugs of butyric acid for administration, which includes amide derivatives such as FBA. The administration can be oral (claim 8), in combination with adjuvants or vehicle and other active ingredients such as drugs, dietary supplements, functional foods, nutraceuticals (claims 9-11).
a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable
One of ordinary skill has the knowledge that butyric acid supplementation for covid prevention can include amide derivatives such as FBA.
Moreover, the properties of the composition as set forth in claim 5 is inherent to the product.
For the reasons provided above, the present claims are found to be prima facie obvious over the prior art.
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621
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