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 02/03/2023 is a National Stage entry of PCT/US2021/044455, International Filing Date: 08/04/2021. PCT/US2021/044455 Claims Priority from Provisional Application 63060912, filed 08/04/2020; and Priority from Provisional Application 63060920, filed 08/04/2020.
Status of Claims
Claims 1, 3-5, 7-8, 10, and 12-22 are pending as of the response filed on 11/26/25. Claims 2, 6, 9, and 11 have been canceled.
Applicant’s election without traverse of the condition, systemic inflammatory response syndrome in the reply filed on 11/26/25 is acknowledged. All claims read on the elected condition.
Claims 1, 3-5, 7-8, 10, and 12-22 were examined. Claims 1, 3-5, 7-8, 10, and 13-22 are rejected. Claim 12 is objected to.
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) 1, 3, 7-8, 10, 13, and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kessler et. al., US 20040097404 A1, publ. 5/20/2004.
Kessler teaches a supplement to be enterally administered to critically or chronically ill patients, or patients with malnutrition, wherein the supplement composition comprises glutamine and/or glutamine precursors in an amount between 15-70 g; at least two antioxidants; and short-chain fatty acids (SCFA) and/or SCFA precursors in an amount between 0.5-10 g. (title & abstract; para [0001], [0020]). Kessler teaches SCFAs to include propionic and butyric acid, with these acids exemplified (para [0025], [0075], [0078]). Kessler teaches severely traumatized patients can experience a high incidence of sepsis and multiorgan failure, as well as the increase in the production of proinflammatory cytokines and mediators IL-1, IL-2, TNF-α, and prostaglandin E2; these mediators also result in the development of systemic inflammatory response syndrome (SIRS) (para [0005]). In addition, Kessler teaches administering the supplement composition as described for the treatment of a patient with SIRS (para [0040-0046]).
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 SIRS in a subject in need thereof comprising administering a composition comprising a therapeutically effective amount of a first SCFA, butyrate, and a therapeutically effective amount of a second SCFA, propionate, in consideration of the teachings of Kessler. Kessler teaches treatment of conditions including SIRS by administering a supplement composition comprising glutamine and/or glutamine precursors in an amount between 15-70 g; at least two antioxidants; and (SCFA) in an amount between 0.5-10 g., with butyrate and propionate both exemplified as SCFAs. Since the amount of SCFA is taught to range between 0.5-10 g., it would have been prima facie obvious to one of ordinary skill in the art to have arrived at an amount of one SCFA of 0.5 g. and 5 g. for the other SCFA, e.g., propionate to butyrate, which would correspond to a ratio of butyrate to propionate of 10:1, thereby meeting the limitations of instant claims 1 and 7. Similarly, based on the guidance provided by Kessler, it would have been prima facie obvious to one of ordinary skill in the art to have arrived at an amount of one SCFA of about 0.7 g. and 10 g. for the other SCFA, e.g., propionate to butyrate, which would correspond to a ratio of butyrate to propionate of about 15:1, thereby meeting the limitation of instant claim 8, in the absence of evidence indicating the criticality of the claimed ratios. See MPEP 2144.05(II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding instant claim 3, Kessler teaches SIRS to be due to the release of proinflammatory immune mediators and cytokines such as IL-1, IL-2, TNF-α, and prostaglandin E2; therefore it would have been prima facie obvious to have treated SIRS due to cytokine release syndrome.
Regarding instant claim 10, 4000 mg is included within the amount of SCFA taught by Kessler, therefore one of ordinary skill in the art would have arrived at this amount in view of the guidance provided by Kessler.
Regarding instant claim 13, the teaching of at least two antioxidants in the supplement composition by Kessler meets the limitation of a pharmaceutically acceptable excipient.
Regarding instant claims 15-19, “wherein the administering modulates an effect of the subject’s immune system”, “wherein the administering reduces a level of a cytokine in the subject”, “wherein the cytokine is an interferon”, “wherein the cytokine is an interleukin”, and “wherein the cytokine is a tumor necrosis factor”, Kessler teaches treating the condition as claimed by administering a composition that includes the same SCFAs. Moreover, the ratio of butyrate to propionate as claimed would have been prima facie obvious in view of the guidance provided by Kessler with respect to the amounts of SCFAs. Therefore, it would have been obvious administering a composition comprising the same ingredients as recited by the claims to the same patient population would have resulted in the same biological effects as recited by claims 15-19.
Regarding instant claim 20, Kessler teaches the composition to further comprise glutamine, thereby meeting the limitation of administering a therapeutically effective amount of a second therapeutic agent.
Claim(s) 4 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kessler et. al., US 20040097404 A1 as applied to claims 1, 3, 7-8, 10, 13, and 15-20 above, and further in view of Zanin et. al., Acta Neurochirurgica, vol. 162, pp. 1491-1494, publ. 5/4/2020.
The disclosure of Kessler as discussed previously is incorporated herein. Although Kessler teaches treatment of SIRS, treatment of SIRS caused by SARS-CoV-2 infection, and administration of an antiviral or antibiotic agent is not explicitly taught or suggested.
Zanin teaches SARS-CoV-2 infection can cause SIRS (see abstract). Zanin further teaches administration of an antiretroviral agent and hydroxychloroquine, known to possess antibacterial activity, to a subject diagnosed with SARS-CoV-2 who developed SIRS (abstract; p. 1491, beginning with Case report para-p. 1492, left col., 2nd para).
Kessler teaches the composition comprising glutamine and/or glutamine precursors in an amount between 15-70 g; at least two antioxidants; and short-chain fatty acids (SCFA) and/or SCFA precursors in an amount between 0.5-10 g., with propionate and butyrate exemplified, for treating SIRS. As such, one of ordinary skill in the art would have found it prima facie obvious to have treated SIRS caused by SARS-CoV-2 in a subject in need thereof, as Zanin teaches SARS-CoV-2 can cause SIRS, and have had a reasonable expectation of success. Furthermore, as Zanin teaches an antiretroviral and hydroxychloroquine were administered to a SARS-CoV-2 patient exhibiting SIRS, it would have been further prima facie obvious to have administered these agents to a patient suffering from SIRS caused by SARS-CoV-2.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kessler et. al., US 20040097404 A1 as applied to claims 1, 3, 7-8, 10, 13, and 15-20 above, and further in view of Bamborough et. al., WO 2011054851 A1, publ. 5/12/2011.
The disclosure of Kessler as discussed previously is incorporated herein. Although Kessler teaches treatment of SIRS, treatment of SIRS caused by influenza infection is not explicitly taught or suggested.
Bamborough teaches SIRS can be associated with viral infections such as influenza and coronavirus (p. 19, lines 23-31).
Kessler teaches the composition comprising glutamine and/or glutamine precursors in an amount between 15-70 g; at least two antioxidants; and short-chain fatty acids (SCFA) and/or SCFA precursors in an amount between 0.5-10 g., with propionate and butyrate exemplified, for treating SIRS. As such, one of ordinary skill in the art would have found it prima facie obvious to have treated SIRS caused by influenza in a subject in need thereof, as Bamborough teaches influenza can cause SIRS, and have had a reasonable expectation of success.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kessler et. al., US 20040097404 A1 as applied to claims 1, 3, 7-8, 10, 13, and 15-20 above, and further in view of Feitelson et. al., WO 2018140687 A1, publ. 8/2/2018.
The disclosure of Kessler as discussed previously is incorporated herein. Although Kessler teaches treatment of SIRS and a pharmaceutically acceptable excipient, cellulose as an excipient is not explicitly taught or suggested.
Feitelson teaches SCFA compositions for the treatment of various diseases and disorders (title & abstract; p. 2, lines 13-17). Feitelson exemplifies butyrate and propionate as SCFAs (p. 3, line 15; p. 4, line 20-21), and additionally teaches compositions for enteral and parenteral administration (p. 73, line 29-p. 74, line 4). Cellulose is further exemplified as an excipient for the compositions (p. 21, lines 12-31; p. 72, lines 8-12).
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 arrived at the instantly claimed method of treating SIRS and have incorporated cellulose into the composition administered in consideration of Kessler and Feitelson. Kessler teaches an enteral SCFA composition, with propionate and butyrate exemplified as SCFA, for the treatment of SIRS, while Feitelson teaches cellulose as an acceptable excipient for enteral SCFA compositions. As such, one of ordinary skill in the art would have been motivated to have selected cellulose as an excipient for the administered SCFA composition of Kessler, in consideration of the guidance provided by Feitelson of cellulose as an acceptable excipient for SCFA compositions.
Claim Objection
Claim 12 is 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.
Information Disclosure Statements
The IDS filed on 5/31/24 and 12/1/25 have been considered.
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