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 of Claims
Claims 1, 3-5, 7-8, 10, and 13-22 are pending as of the response and amendments filed on 7/10/26. Claims 2, 6, 9, and 11-12 have been canceled.
Claims 1, 3, 7-8, 10, 13, and 15-20 were previously rejected under 103 over Kessler; claims 4 and 21-22 were previously rejected under 103 over Kessler in view of Zanin; claim 5 was previously rejected under 103 over Kessler in view of Bamborough; and claim 14 was previously rejected under 103 over Kessler, further in view of Feitelson. In response to these rejections, Applicant has stated while they don’t agree with the rejections, they are overcome by the incorporation of the limitations of previous claim 12 into independent claim 1, therefore the rejections should be withdrawn as claim 12 was objected to but not rejected.
Applicant’s arguments are not persuasive. While claim 12 was objected to and not rejected, amended claim 1 doesn’t fully incorporate the limitations of previous claim 12. Claim 12 required the amount of the second short chain fatty acid as about 250 mg.; however, claim 1 as amended recites “and wherein the therapeutically-effective amount of the short chain fatty acid is about 250 mg”. The amount of 250 mg. as written in amended claim 1 isn’t specifically applied to the second short chain fatty acid, and as two different short chain fatty acids are administered, introduces indefiniteness into claim 1 as currently amended. However, the 103 rejections of record are withdrawn by the amendments.
Based on the amendments, new rejections under 35 USC 112(b) and 103 are made, discussed below.
Claims 1, 3-5, 7-8, 10, and 13-22 were examined and are rejected.
Claim Rejection-35 USC § 112 Necessitated by Amendments
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-5, 7-8, 10, and 13-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 as amended recites “and wherein the therapeutically-effective amount of the short chain fatty acid is about 250 mg”. This language renders the claim indefinite, since claim 1 requires the administration of two different short chain fatty acids, butyric acid and propionic acid, and it is uncertain if 250 mg. applies to the first or second acid, or to both acids. The metes and bounds aren’t clear. Dependent claims 3-5, 7-8, 10, and 13-22 are similarly rejected and don’t provide further clarity.
To provide compact prosecution, “and wherein the therapeutically-effective amount of the short chain fatty acid is about 250 mg” was interpreted as applying to either the first or second short chain fatty acid.
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, and 13-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spector, WO 2018140687 A1, publ. 8/2/2018.
Spector teaches compositions and methods of treatment involving the administration of short chain fatty acids (SCFAs) (title & abstract). Spector teaches SCFAs as the main metabolites of anaerobic bacteria fermentation in the intestine, and changes in the concentration of the gut microbiome are linked with the development of various diseases (p. 1, lines 14-22). Spector teaches SCFAs as important regulators of inflammation, influencing the balance between pro- and anti-inflammatory cells and a means of communication between the microbiota and immune system (p. 1, line 26-p. 2, line 7). Spector teaches an embodiment wherein the composition comprises at least two SCFAs, particularly butyrate and propionate (p. 3, lines 9-15; p. 117, claims 9 & 10). Spector teaches the composition comprises between 100 mg. to 6 g. of at least one SCFA (p. 4, lines 14-15), and teaches administering the composition to treat adverse effects of chemotherapy, including cytokine release syndrome (CRS) (p. 10, lines 27-31; p. 46, lines 19-27). In particular, Spector teaches SCFAs as broadly anti-inflammatory via modulation of NF-ĸB, and that SCFAs downregulate the production of TNFα and IL-6, which are commonly elevated in CRS (p. 114, lines 10-22). Spector teaches administering SCFAs in combination with chemotherapy (p. 115, lines 10-14). Spector also provides an exemplary treatment regimen comprising a 3600 mg dose of butyric acid, and a 400 mg. dose of propionic acid, a ratio of butyric acid : propionic acid of 9:1 (p. 99, see Suggested treatment box); additionally, Spector teaches administering an oral dose to an adult subject, comprising one SCFA at an amount between 0.1 g.-15 g. (p. 94, lines 21-27), and more particularly between about 1 mg and 2500 mg (p. 69, line 24-p. 70, line 2). Chemotherapeutic agents that can be administered in combination with the SCFAs include antiviral agents (p. 66, line 24-p. 67, line 14), and antibacterial agents (p. 67, line 23-p. 68, line 6). Spector teaches the inclusion of a pharmaceutically acceptable carrier in the composition, including cellulose and derivatives thereof (p. 21, lines 12-31; p. 83, line 27-p. 84, line 2).
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 particular CRS 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 Spector. Kessler teaches treatment of conditions including CRS by administering a combination of SCFAs, with butyrate and propionate exemplified. Since the amount of SCFA is taught to range in an embodiment between 1 mg and 2500 mg, or between 0.1 g -15 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 250 mg. and at least 2500 mg., up to 4000 mg. 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 Spector, 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 16, reducing a level of a cytokine in a subject, and instant claims 17-18, wherein the cytokine to be reduced is an interferon, Spector teaches SCFAs are anti-inflammatory and modulate NF-ĸB, and that NF-ĸB stimulates production of proinflammatory cytokines IL-6, TNFα, and IFNɣ, which are all elevated in CRS (p. 114, lines 10-22). As Spector teaches administering the combination of butyrate and propionate to treat CRS, it would have been prima facie obvious to one of ordinary skill in the art the levels of IL-6, TNFα, and IFNɣ would have been reduced as a result. Regarding instant claim 19, wherein the cytokine is a TNF, see explanation above.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spector, WO 2018140687 A1 as applied to claims 1, 3, 7-8, 10, and 13-22 above, and further in view of Zanin et. al., Acta Neurochirurgica, vol. 162, pp. 1491-1494, publ. 5/4/2020.
The disclosure of Spector as discussed previously is incorporated herein. Although Spector teaches treatment of SIRS, more particularly CRS, treatment of SIRS caused by SARS-CoV-2 infection 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).
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. As discussed previously, Spector teaches the combination of butyrate and propionate to treat CRS; as SARS-CoV-2 can also cause this condition, one of ordinary skill in the art would have been motivated to have administered the combination of butyrate and propionate as claimed to treat CRS induced by SARS-CoV-2.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spector, WO 2018140687 A1 as applied to claims 1, 3, 7-8, 10, and 13-22 above, and further in view of Bamborough et. al., WO 2011054851 A1, publ. 5/12/2011.
The disclosure of Spector as discussed previously is incorporated herein. Although Spector 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).
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 Spector teaches the combination of butyrate and propionate for treating SIRS, more particularly CRS. As such, one of ordinary skill in the art would have been motivated to have administered the combination of butyrate and propionate to treat CRS caused by influenza.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Correspondence
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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