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 . Claims 1-8 and 38-40 filed April 06, 2026 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group (I) claims 1-6 in the reply filed on 04/06/2026 is acknowledged.
Claims 38-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/06/2026.
Secondly, Applicant’s election without traverse of graft-vs-host disease as the T-cell mediated intestinal disorder and butyrate as the species of agent in the reply filed on 04/06/2026 is acknowledged.
Priority
Acknowledgement is made of the national stage entry of PCT/US2022/011633 filed 01/07/2022 which claims priority to U.S. Provisional Application 63134723 filed 01/07/2021.
Claim Rejections - 35 USC § 112-Paragraph A
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.
Claims 1-8 are 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the present case, the claims are directed to the method of treating, ameliorating, or preventing a T cell mediated intestinal disorder in a patient comprising administering to a patient suffering from or at risk of suffering from a T cell mediated intestinal disorder a therapeutically effective amount of a composition comprising a therapeutic agent capable of preventing and/or hindering one or more of reduced IEC related SDHA activity and/or expression; reduced IEC related oxidative phosphorylation; increased IEC related succinate accumulation; and increased IEC related accumulation of perforin dependent granzyme B related to cytotoxic T cell engagement with such IECs.
(1) Partial structure:
The genus of “a therapeutic agent capable of preventing and/or hindering one or more of reduced IEC related SDHA activity and/or expression; reduced IEC related oxidative phosphorylation; increased IEC related succinate accumulation; and increased IEC related accumulation of perforin dependent granzyme B related to cytotoxic T cell engagement with such IECs” is described by its function without sufficient description of its structure. There is no known or disclosed structure/function relationship provided in the claims or the specification, nor blazemarks within the specification to identify which chemical structures are capable of preventing and/or hindering one or more of reduced IEC related SDHA activity and/or expression; reducing IEC related oxidative phosphorylation; increasing IEC related succinate accumulation; and increasing IEC related accumulation of perforin dependent granzyme B related to cytotoxic T cell engagement with such IECs, and which chemical structures do not yield these functional effects.
As described in MPEP § 2163, for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. As shown in the working examples in the specification and Figure 18, Applicant has one working example of a compound that capable of preventing and/or hindering one or more of reduced IEC related SDHA activity and/or expression; reduced IEC related oxidative phosphorylation; increased IEC related succinate accumulation; and increased IEC related accumulation of perforin dependent granzyme B related to cytotoxic T cell engagement with such IECs, and that single disclosed compound is butyrate.
In the present case, claim 5 narrows the genus of compound embodied in claim 1 to butyrate or a compound that is structurally similar to butyrate. As disclosed above, the genus of a therapeutic agent capable of preventing and/or hindering one or more of reduced IEC related SDHA activity and/or expression comprises substantial variance as there is no structure-function relationship to identify which chemical structures read on the claimed genus and which chemical structures do not yield said function. There is also substantial variance regarding the genus of “structurally similar to butyrate”. There are no blazemarks within the specification to identify which chemical structures read on the genus of “structurally similar to butyrate”, let alone how far the compound can deviate from the parent compound butyrate and still lie inside the genus of “structurally similar to butyrate”. For example, does the short chain fatty acid hexanoate (structurally similar to butyrate but comprises a longer alkylene chain) read on the genus of “structurally similar to butyrate”, or alternatively lie outside the reported genus? In the third alternative, does the graft-vs-host disease treating phenylbutyric acid, as shown in Mukai (WO2017/175808 published 10/12/2017 with English Translation found in US2019/0192458 published 06/27/2019) read on the genus of “structurally similar to butyrate”, or alternatively lie outside the reported genus?
(2) Physical and/or chemical properties and (3) Functional characteristics:
As recited in the partial structure section above, the genus is described by its function. However no structure/function relationship is disclosed for the claimed genus is provided, nor are distinct physical or chemical properties of said genus.
(4) Method of making the claimed invention:
Methods of synthesizing compounds is, in general, known to the artisan, however methods of making the myriad of compounds embraced by functionally claimed genus in the instant claims is beyond the skill of the artisan, particularly when the genus is merely described without any structural blazemarks. As such, the instant specification and instant claims do not provide sufficient description such that one could arrive at yielding the compounds of the presently claimed genus.
As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad and generic, with respect to all possible compounds encompassed by the claims. The possible structural variations are limitless. Although the claims recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond those compounds specifically disclosed in the examples in the specification. Moreover, as stated above, the specification lacks sufficient variety of species to reflect this variance in the genus. Thus, the specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim Rejections - 35 USC § 112-Paragraph B
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 5 and 8 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 5 recites the limitation of selected from butyrate (e.g., sodium butyrate) and a compound structurally similar to butyrate.
Regarding claim 5, the phrase "for example (e.g.) sodium butyrate" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase (e.g.) are part of the claimed invention. See MPEP § 2173.05(d). This situation is duplicated in claim 8. Accordingly, one of ordinary skill in the art would not have been reasonably apprised of the metes and bounds of the subject matter for which Applicant was presently seeking protection.
Claims 5 and 8 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.
The term “structurally similar to butyrate” in claims 5 and 8 is a relative term which renders the claim indefinite. The term “structurally similar to butyrate” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As disclosed in the 35 U.S.C 112 paragraph A rejection above, there are no blazemarks within the specification to identify which chemical structures read on the genus of “structurally similar to butyrate”, let alone how far the compound can deviate from the parent compound butyrate and still lie inside the genus of “structurally similar to butyrate”. For example, does the short chain fatty acid hexanoate (structurally similar to butyrate but comprises a longer alkylene chain) read on the genus of “structurally similar to butyrate”, or alternatively lie outside the reported genus? In the third alternative, does the graft-vs-host disease treating phenylbutyric acid, as shown in Mukai (WO2017/175808 published 10/12/2017 with English Translation found in US2019/0192458 published 06/27/2019) read on the genus of “structurally similar to butyrate”, or alternatively lie outside the reported genus?
As recited in MPEP 2173.05(a), the meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention." In re Packard, 751 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir. 2014). In the present case, the metes and bounds regarding the phrase “structurally similar to butyrate” are vague and opaque and one of ordinary skill in the art would not have been readily apprised of the subject matter for which Applicant was presently seeking protection.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reddy (WO2017/160944 published 09/21/2017).
Claim interpretation is as follows. Claim 1 is directed to a method for treating, ameliorating, or preventing a T cell mediated intestinal disorder in a patient comprising administering to a patient suffering from or at risk of suffering from a T cell mediated intestinal disorder a therapeutically effective amount of a composition comprising a therapeutic agent capable of preventing and/or hindering one or more of reduced IEC related SDHA activity and/or expression; reduced IEC related oxidative phosphorylation; increased IEC related succinate accumulation; and increased IEC related accumulation of perforin dependent granzyme B related to cytotoxic T cell engagement with such IECs. Claims 2-3 further limit the T-cell mediated intestinal disorder to graft vs host disease, inflammatory bowel disease or immune checkpoint blockade, while claim 5 further limits the therapeutic agent to butyrate or a compound structurally similar to butyrate. Claim 6 is directed to the functional effect of the administered therapeutic agent to hinder one or more of reduced IEC related SDHA activity and/or expression; reduce IEC related oxidative phosphorylation; increase IEC related succinate accumulation; and increase IEC related accumulation of perforin dependent granzyme B related to cytotoxic T cell engagement with such IECs.
Reddy teaches graft-vs-host disease of the intestine results in severe intestinal inflammation, sloughing of the mucosal membrane, severe diarrhea, and vomiting (page 10). Reddy teaches that intestinal microbiota, such as short chain fatty acids are significantly altered in patients following graft-vs-host disease (GVHD, pages 49-51). Reddy teaches that following allogenic bone-marrow transplantation, the amount of short-chain fatty acid and histone deacetylase inhibitor butyrate was significantly reduced only in intestinal tissue (pages 50-51, pages 60-61, Figure 1b). Butyrate is a preferred energy source for intestinal epithelial cells (IECs) (page 51). The reduced amount of butyrate in said tissue resulted in a decreased histone acetylation. Reddy further teaches that the reduced amount of butyrate in the intestinal tissue in said allogenic patients was due to decreased uptake of microbiota-derived luminal butyrate (page 65-66, Figure 3.). As shown in Figure 3, allo-GVHD patients with reduced levels of butyrate in the intestinal tissue comprise poor-overall prognosis and pronounced GVHD.
Reddy teaches improving the levels of butyrate in the afflicted graft-vs-host disease patient comprising systemic administration of butyrate to said allogenic bone-marrow transplant patient, in doses of 10 mg/kg (page 53, page 63). As shown in Figures 3-4, said administration of butyrate to gastrointestinal GVHD patients, protects GI epithelium, improved the graft-vs-host disease score and improved survival in the afflicted GVHD patient (pages 63-67).
Regarding the limitation wherein the therapeutically effective amount of butyrate hindered one or more of reduced IEC related SDHA activity and/or expression; reduced IEC related oxidative phosphorylation; increased IEC related succinate accumulation; and increased IEC related accumulation of perforin dependent granzyme B related to cytotoxic T cell engagement with such IECs, although said property was not explicitly described in the cited prior art butyrate therapeutic regimen to GI GVHD patients in Reddy, the compound (butyrate), the dose (10mg/kg), and the same patient population (a patient with the T-cell mediated intestinal disorder of GI GVHD) are identical to that of instantly claimed. Therefore, the property of the compound to "hinder one or more of reduced IEC related SDHA activity and/or expression; reduce IEC related oxidative phosphorylation; increase IEC related succinate accumulation; and increase IEC related accumulation of perforin dependent granzyme B related to cytotoxic T cell engagement with such IECs” in the treated patient must necessarily be present in the prior art regimen of Reddy, because products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the prior art teaches the identical chemical or physical structure of the composition, (i.e., the same active agent, butyrate), and the composition is used in the same manner (i.e., administered in the same manner to the same subject in the same therapeutically effective amount), the properties that Applicant discloses and/or claims must necessarily be present. Furthermore, as stated in MPEP 2112.02, “[u]nder the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered anticipated by the prior art device.”
Claim(s) 1-3, 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mathewson (Nature Immunology vol. 17 pages 505-517 published 2016).
Mathewson (Nature Immunology vol. 17 pages 505-517 published 2016) teaches the effects of alterations of intestinal microbiota, such as short chain fatty acids on microbial metabolites following graft-vs-host disease (GVHD). Mathewson teaches that following allogenic bone-marrow transplantation, the amount of short-chain fatty acid butyrate was significantly reduced in intestinal tissue (page 506, page 511, Figure 1). The reduced amount of butyrate in said tissue resulted in a decreased histone acetylation. Mathewson further teaches that the reduced amount of butyrate in the intestinal tissue in said allogenic patients was due to decreased uptake of microbiota-derived luminal butyrate (page 506 right col.). As shown in Figure 3, allo-GVHD patients with reduced levels of butyrate in the intestinal tissue comprise poor-overall prognosis and pronounced GVHD.
Mathewson teaches rescuing the levels of butyrate in the afflicted graft-vs-host disease patient comprising systemic administration of butyrate to said allogenic bone-marrow transplant patient. As shown in Figures 3-5, said administration of butyrate resulted in improving IEC junction integrity, improved the graft-vs-host disease score and improved survival in the afflicted GVHD patient (pages 507-508).
Regarding the limitation wherein the therapeutically effective amount of butyrate hindered one or more of reduced IEC related SDHA activity and/or expression; reduced IEC related oxidative phosphorylation; increased IEC related succinate accumulation; and increased IEC related accumulation of perforin dependent granzyme B related to cytotoxic T cell engagement with such IECs, although said property was not explicitly described in the cited prior art butyrate therapeutic regimen to GI GVHD patients in Mathewson, the compound (butyrate), the dose (10mg/kg), and the same patient population (a patient with the T-cell mediated intestinal disorder of GI GVHD) are identical to that of instantly claimed. Therefore, the property of the compound to "hinder one or more of reduced IEC related SDHA activity and/or expression; reduce IEC related oxidative phosphorylation; increase IEC related succinate accumulation; and increase IEC related accumulation of perforin dependent granzyme B related to cytotoxic T cell engagement with such IECs” in the treated patient must necessarily be present in the prior art regimen of Mathewson, because products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the prior art teaches the identical chemical or physical structure of the composition, (i.e., the same active agent, butyrate), and the composition is used in the same manner (i.e., administered in the same manner to the same subject in the same therapeutically effective amount), the properties that Applicant discloses and/or claims must necessarily be present. Furthermore, as stated in MPEP 2112.02, “[u]nder the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered anticipated by the prior art device.”
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) 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Reddy (WO2017/160944 published 09/21/2017).
Reddy (WO2017/160944 published 09/21/2017) teaches graft-vs-host disease of the intestine results in severe intestinal inflammation, sloughing of the mucosal membrane, severe diarrhea, and vomiting (page 10). Reddy teaches that intestinal microbiota, such as short chain fatty acids are significantly altered in patients following graft-vs-host disease (GVHD, pages 49-51). Reddy teaches that following allogenic bone-marrow transplantation, the amount of short-chain fatty acid and histone deacetylase inhibitor butyrate was significantly reduced only in intestinal tissue (pages 50-51, pages 60-61, Figure 1b). Butyrate is a preferred energy source for intestinal epithelial cells (IECs) (page 51). The reduced amount of butyrate in said tissue resulted in a decreased histone acetylation. Reddy further teaches that the reduced amount of butyrate in the intestinal tissue in said allogenic patients was due to decreased uptake of microbiota-derived luminal butyrate (page 65-66, Figure 3.). As shown in Figure 3, allo-GVHD patients with reduced levels of butyrate in the intestinal tissue comprise poor-overall prognosis and pronounced GVHD.
Reddy teaches improving the levels of butyrate in the afflicted graft-vs-host disease patient comprising systemic administration of butyrate to said allogenic bone-marrow transplant patient, in doses of 10 mg/kg (page 53, page 63). As shown in Figures 3-4, said administration of butyrate to gastrointestinal GVHD patients, protects GI epithelium, improved the graft-vs-host disease score and improved survival in the afflicted GVHD patient (pages 63-67). Regarding claims 4, 7, treatment of human graft-vs-host disease patients is embraced within the methodology of Reddy (page 6, page 45).
Therefore, one of ordinary skill in the art prior to the time of the invention, knowing that administration of butyrate to patients comprising gastrointestinal graft-vs-host-disease is efficacious at protecting the GI epithelium, improving the GVHD score and improving survival in the afflicted patient as taught by Reddy above, said skilled artisan would have found it prima facie obvious to administer butyrate to a human patient suffering from gastrointestinal graft-vs-host-disease in view of Reddy, arriving at the presently claimed methodology with a reasonable expectation of success.
Considering Reddy teaches that the administration of butyrate is efficacious at improving survival in a gastrointestinal graft-vs-host-diseased patient and suitable to administer to a human subject, said skilled artisan would have readily predicted that administration of said therapeutically effective amount of butyrate to a human patient comprising gastrointestinal graft-vs-host-disease would have protected the GI epithelium and improved survival in the human patient afflicted with gastrointestinal graft-vs-host-disease.
Conclusion
In view of the rejections set forth above, no claim is allowed.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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