DETALIED 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 .
Status of the Application
Claims 1-19 are pending.
Priority
This application filed on 12/20/2023, claims the benefit of U.S. Provisional Patent Application No. 63/433,817, filed on 12/20/2022.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 11/02/2025, complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
Election/Restriction
Applicant’s response filed on 06/03/2026 to Restriction/Election Requirement filed on 05/04/2026, is acknowledged. Applicant elected without traverse Group I drawn to a method of treating a subject having, or at risk of having, leaky gut caused by hydrogen sulfide producing bacteria comprising administering to the subject an amount of a composition comprising a Snail inhibitor or an inhibitor of sulfate reducing bacteria. Claims 1-10 and 19 read on the elected Group. Claims 11-18 of Group II are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Pursuant to the Election of Species Requirement, Applicant respectively elected without traverse, snail inhibitor and rapamycin as the species of snail inhibitor for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Claims 1-8 read on the elected species. Thus, claims 1-19 are pending with claims 9-19 withdrawn from further consideration, and claims 1-8 are under consideration.
Claim interpretation
Examination requires claim terms first be construed in terms in the broadest reasonable manner during prosecution as is reasonably allowed in an effort to establish a clear record of what applicant intends to claim. See MPEP § 2111. Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. See MPEP § 2111.01. It is also appropriate to look to how the claim term is used in the prior art, which includes prior art patents, published applications, trade publications, and dictionaries. MPEP § 2111.01 (III). However, specific embodiments of the specification cannot be imported into the claims, particularly where the subject claim limitation is broader than the embodiment. MPEP § 2111.01(II).
Claim interpretation for “effective amount”
Claims 1-8 recite administering an effective amount. The instant specification
The method includes administering an effective amount of a therapeutic composition that includes a Snail inhibitor or an inhibitor of sulfate reducing bacteria (collectively hereafter, "active agent") to a subject having, or at risk of having, a particular condition. In this aspect, an "effective amount" is an amount effective to reduce, limit progression, ameliorate, or resolve, to any extent, a symptom or clinical sign related to the condition. For example, an effective amount can be an amount of the active agent effective to inhibit overgrowth or bloom of sulfate reducing bacteria. In other embodiments, an effective amount can be an amount effective to decrease Snail expression in treated cells compared to untreated cells, decrease FITC-dextran flux in treated cells compared to untreated cells, decrease the percentage of cells with Snail localized in the nucleus in treated cells compared to untreated cells, decrease cytoplasmic localization of occludin in treated cells compared to untreated cells, and/or increase paracellular localization of occluding in treated cells compared to untreated cells. [page 31, line 1-13].
The instant specification also recites:
“A single dose may be administered all at once, in multiple discrete administrations, or continuously for a prescribed period of time. For example, one dosing regimen for the model Snail inhibitor intestinal alkaline phosphatase includes administering 67.5 U/kg over 10 minutes via intravenous bolus, followed by administering 132.5 U/kg via intravenous infusion over up to 48 hours. [page 33, line 7-11].
the instant specification does not define this amount quantitatively. On pg. 32 of the spec, the spec exemplifies amounts of 67.5U/kg-1000U/kg. U (unless specifically defined as any unit, e.g., mg, g, …). can be ANY unit of measurement. The instant specification does not define these amounts and only provides examples of the what the dosages can be, wherein the examples are any unit of measurement, thereby encompassing a broad range of amounts.
In view of compact prosecution, for the purpose of applying prior art, the “effective amount” is given its plain meaning know in the art as the amount effective in achieving the intended results, and in this case, “effective amount” is interpreting as any amount that treats a subject having a leaky gut.
Claim interpretation for “at risk of having leaky gut
Claim 1 recites “method of treating a subject having, or at risk of having, leaky gut caused by hydrogen sulfide producing bacteria …”
The instant specification described the term “at risk” as:
As used herein, the term "at risk" refers to a subject that may or may not actually possess the described risk. Thus, for example, a subject "at risk" of a condition involving gut permeability is a subject possessing one or more risk factors associated with conditions involving gut permeability such as, for example, genetic predisposition, ancestry, age, sex, geographical location, lifestyle, or medical history. [page 30, line 9-14].
The term is broadly and reasonably interpreted consistent with the instant specification.
Claim objection
Claim 1 is objected to because of the following informalities:
Claim 1 recites “… administering to the subject an amount of a composition effective to reduce ameliorate at least one symptom or clinical sign of leaky gut … .”
It appears that there is a typo in the recitation “to reduce ameliorate”. The recitation should include an “and” or an “or” between reduce and ameliorate. For example, the claim could be amended to read: “…to reduce or ameliorate...”
Appropriate correction is required.
Rejections 35 U.S.C. 112(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.
Claims 1-8 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.
Claims 1-7 recite: a method of treating a subject having, or at risk of having, leaky gut caused by hydrogen sulfide producing bacteria, the method comprising: administering to the subject an amount of a composition effective to reduce ameliorate at least one symptom or clinical sign of leaky gut caused by hydrogen sulfide producing bacteria, the composition comprising a Snail inhibitor or an inhibitor of sulfate reducing bacteria (Claim 1), wherein the composition is administered in an amount effective to inhibit overgrowth or bloom of hydrogen sulfide producing bacteria (claim 2), wherein the composition is administered in an amount effective, to decrease Snail expression in treated cells compared to untreated cells (claim 3)…”
A claim term is functional when the claim recites functional limitations that do not provide the structure that performs the recited function. Instant claims 1-7 recites functions without precisely defining the present structural attributes that convey the claimed function. The amount of the active agent, Snail inhibitor that is effective to provide the claimed functions is neither described in the claims nor in the specification.
The use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008).
Dependent claim 8 is indefinite due to its dependence on a rejected claim and lacking any limitations that cure the ambiguities resulting from the parent claim(s).
Claim Rejections - 35 USC § 112(a) Written Description
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 for a generic claim can be adequately described if the disclosure presents a sufficient number of representative species in examples that encompass the genus. (MPEP § 2163). A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
The Guidelines for Examination of Patent Applications under the 35 USC § 112, first paragraph, “Written Description” Requirement”, published at Federal Register, Vol. 66, No. 4, pp. 1099-1111 outline the method of analysis of claims to determine whether adequate written description is present. The first step is to determine what the claim as a whole cover, i.e., discussion of the full scope of the claim. Second, the application should be fully reviewed to understand how applicant provides support for the claimed invention including each element and/or step, i.e., compare the scope of the claim with the scope of the description. Third, determine whether the applicant was in possession of the claimed invention as a whole at the time of filing. Each of these factors has been considered, with the most relevant factors discussed below. For each claim drawn to a genus, each of these factors is to be considered to determine whether there is disclosure of a representative number of species that would lead one skilled in the art to conclude that applicant was in possession of the claimed invention.
The instant claim 1 is directed to “a method of treating a subject having, or at risk of having, leaky gut caused by hydrogen sulfide producing bacteria, the method comprising: administering to the subject an amount of a composition effective to reduce ameliorate at least one symptom or clinical sign of leaky gut caused by hydrogen sulfide producing bacteria, the composition comprising a Snail inhibitor or an inhibitor of sulfate reducing bacteria.
The instant claims 1-8 failing to comply with the written description requirement because neither the application as filed nor the art of record disclose the effective amount of Snail inhibitor, rapamycin that perform the function of
reduce ameliorate at least one symptom or clinical sign of leaky gut caused by hydrogen sulfide producing bacteria;
inhibit overgrowth or bloom of hydrogen sulfide producing bacteria;
decrease Snail expression in treated cells compared to untreated cells;
decrease FITC-dextran flux in treated cells compared to untreated cells;
decrease the percentage of cells with Snail localized in the nucleus in treated cells compared to untreated cells;
decrease cytoplasmic localization of occludin in treated cells compared to untreated cells; or
increase paracellular localization of occluding in treated cells compared to untreated cells, or
a structure-function correlation between the amount of snail inhibitor and the claimed function such that one of skill can recognize what amount of rapamycin will perform the functions recited in the claims.
What is conventional or well known to one of ordinary skill in the art need not be disclosed in detail. MPEP § (II)(A)(3)(a). Thus, the state of and predictability in the art is a relevant consideration in determining compliance with § 112(a), written description. MPEP § (II)(A)(3)(a) (citing Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1085 (Fed. Cir. 2005) ("The ‘written description’ requirement must be applied in the context of the particular invention and the state of the knowledge…. As each field evolves, the balance also evolves between what is known and what is added by each inventive contribution”).
The recitation of effective amount is not adequately defined in the instant specification. Instant specification recites:
The method includes administering an effective amount of a therapeutic composition that includes a Snail inhibitor or an inhibitor of sulfate reducing bacteria (collectively hereafter, "active agent") to a subject having, or at risk of having, a particular condition. In this aspect, an "effective amount" is an amount effective to reduce, limit progression, ameliorate, or resolve, to any extent, a symptom or clinical sign related to the condition. For example, an effective amount can be an amount of the active agent effective to inhibit overgrowth or bloom of sulfate reducing bacteria. In other embodiments, an effective amount can be an amount effective to decrease Snail expression in treated cells compared to untreated cells, decrease FITC-dextran flux in treated cells compared to untreated cells, decrease the percentage of cells with Snail localized in the nucleus in treated cells compared to untreated cells, decrease cytoplasmic localization of occludin in treated cells compared to untreated cells, and/or increase paracellular localization of occluding in treated cells compared to untreated cells. [page 31, line 1-13].
The instant specification also recites:
“A single dose may be administered all at once, in multiple discrete administrations, or continuously for a prescribed period of time. For example, one dosing regimen for the model Snail inhibitor intestinal alkaline phosphatase includes administering 67.5 U/kg over 10 minutes via intravenous bolus, followed by administering 132.5 U/kg via intravenous infusion over up to 48 hours. [page 33, line 7-11].
The instant specification provides examples, wherein the agent i.e., rapamycin is administered in a concentration not an amount: “Cells were treated with 100 nM rapamycin.” [page 4].
There is no definition of the effective amount that performs the claimed function, there are no examples in the specification to correlate rapamycin amount and the functional limitations of claims 1-7. Even when the specification recites an amount e.g., 67.5 U/kg, the amount is described as “U”, any unit, unspecified unit, that milligram, nanogram, femtogram, etc. can read on the unit.
The specification does not describe the structure-function relationship between the amount of snail inhibitor, rapamycin and reducing overgrowth or bloom of hydrogen sulfide producing bacteria, decreasing Snail expression, decreasing FITC-dextran flux, etc. There is no art recognize of the active agent, e.g., rapamycin amount that known to perform the claimed function. The unit described by the specification is arbitrary unit. One of ordinary skill in the art would not be able to draw the connection between the effective amount of active agent, e.g., rapamycin and the functional limitations of claims 1-7.
Claim breath is relevant to the instant § 112(a) written description rejection. The written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. MPEP § 2163(II)(A)(3)(a)(ii) (citing Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021)). The effective amount of snail inhibitor, e.g., rapamycin is are completely functionally defined.
Thus, applicant is not in possession of the full claim scope because neither the specification nor the art of record provides sufficient guidance (representative species or a structure-function relationship) allowing one of skill to correctly predict the amounts that are effective in performing the claimed function above. A "representative number of species" means that the species which are adequately described are representative of the entire genus. MPEP § 2163(II)(A)(3)(a)(ii); see also, Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1164 (Fed. Cir. 2019) (“[a]s a result, a POSA is deprived of any meaningful guidance into what amount of snail inhibitor would perform each function of claims 1-7. Further, neither the art nor the specification shows a well-established correlation between the effective amount of snail inhibitors and their respective function of reducing overgrowth or bloom of hydrogen sulfide producing bacteria, decreasing Snail expression, decreasing FITC-dextran flux, etc.
Having analyzed the claims with regard to the written description guidelines, the specification does not describe the effective amounts or relate the functional language of “reducing overgrowth or bloom of hydrogen sulfide producing bacteria, decreasing Snail expression, decreasing FITC-dextran flux, etc.” Thus, one of ordinary skill in the art would be led to conclude that applicants were not in possession of the invention commensurate with the scope of the claims, at the time the application was filed.
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 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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over J. Zhao, et al. (International Immunopharmacology, 2020, Volume 81, 105977, ISSN 1567-5769, “Zhao” cited in the PTO-892) and P. Juricic, et al. (Nat Aging 2, 824–836 (September 2022), “Juricic” cited in the PTO-892) in view of D. Dordevic´ et al. (Journal of Advanced Research 27 (2021) 55–69, “Dordevic´” cited in the PTO-892), S. Jowett et al. (Gut 2004;53:1479–1484, “Jowett” cited in the PTO-892), I. Kushkevych et al. (Journal of Advanced Research, January 2021, Volume 27, Pages 71-78, “Kushkevych” cited in the PTO-892) and B. Perridon et al. (Aging (Albany NY). 2016 Sep 27;8(10):2264-2289, “Perridon” cited in the PTO-892).
Zhao teaches a method of treating disturbance of the intestinal barrier and increased intestinal permeability by administering rapamycin. Zhao teaches that rapamycin treatment ameliorated DAI and histological colitis, decreased pro inflammatory cytokines (TNF-α, IFN-γ and IL-17) and chemotactic factors (CXCL-1 and CXCL-2), decreased intestinal and colonic permeability, significantly improved intestinal barrier function. [Abstract, page 1, col. 2, 2nd para.].
Zhao teaches that the effect of rapamycin on intestinal permeability was evaluated using an FITC analysis, wherein FITC-dextran was injected into the intestinal lumen, and blood sample after thirty minutes was obtained to determine the concentration of FITC-dextran in rapamycin group compared to other groups. Rapamycin is administered in an amount of 2 mg/kg. The tissues and cells of the colon were collected and were evaluated after treatment. [page 2, 2.2, 2.4, 2.6, 2.7, 2.8].
Zhao teaches that untreated groups associated with greatly increased concentrations of FITC-dextran compared to rapamycin-treated. The collected cells showed that the inflammatory cell infiltration and inflammation scores were significantly decreased by rapamycin treatment. Rapamycin significantly improved the increased intestinal and colonic permeability, improved the distribution and expression of TJ protein, a major determinants for the intestinal barrier permeability maintenance, and significantly improved the decrease of occluding and ZO-1 expression observed in untreated mice. Furthermore, occluding and ZO-1 were differently localized in untreated group with a lower TJ density, which was also improved by rapamycin treatment [page 3, 3.1, 3.3, 3.4, Fig. 7, 7a-c].
Juricic teaches a method of treating increase gut permeability by administering rapamycin. Juricic teaches that plasma lipopolysaccharide-binding protein (LBP) levels, a marker of bacterial translocation from intestine into circulation, was measured (Fig. 7b), wherein mice were treated with rapamycin chronically or from 3–6 months of age, and collected samples 6 months after the treatment was withdrawn. Strikingly, 6 months after rapamycin was withdrawn, plasma LBP levels were reduced to levels similar to those with chronic treatment, suggesting that the long-lasting, beneficial effects of short-term rapamycin exposure on intestinal integrity is conserved in mammals. See the effect of rapamycin in cells, Fig. 7. [page 829, 831, col. 2, last para., Fig. 7a, 7b].
Zhao and Juricic teach the claim 1 method of treating increase permeability (leaky gut) by administering snail inhibitor, rapamycin in an amount effective to reduce or ameliorate at least one symptoms or clinical sign of leaky gut, wherein Zhao’s ameliorated DAI and histological colitis, decreased pro inflammatory cytokines and chemotactic factors and decreased intestinal and colonic permeability, and Juricic’s LBP level, bacterial translocation, etc. reads on symptoms or clinical sign of leaky gut, and administering 2 mg/kg of rapamycin reads on the effective amount, see claim interpretation above. However, Zhao and Juricic are silent on the cause of leaky gut.
Dordevic´ teaches that hydrogen sulfide is the final product of sulfate-reducing bacteria metabolism, and its high concentration in the gut can affect adversely bowel environment and intestinal microbiota. [Abstract]. Dordevic´ teaches hydrogen sulfide produced by bacteria damages the intestinal mucosa and it’s the cause for initiation of inflammation that lead to inflammatory diseases and increase intestinal permeability. [page 56, col. 1, 2nd para.]. Dordevic´ teaches that intestinal bacteria are a cause of acute gastroenteritis. Acute gastroenteritis includes intestinal villi deletion, enhanced intestinal permeability and toxin production [page 56, col. 2- page 57]. Dordevic´ also teaches that higher intestinal permeability is associated with higher sulfide production. [page 59, col. 1, 3rd para.].
Jowett teaches Hydrogen sulfide causes increased epithelial permeability, loss of barrier function, and cellular proliferation [page 1479, col. 1, 3rd para.].
Moreover, Kushkevych teaches that increase intestinal permeability is caused by hydrogen sulfide produced by sulfate-reducing bacteria. [page 72, col. 1, page 76, col. 2, whole document].
Perridon teaches the role of hydrogen sulfide produced by sulfate-reducing bacteria in gut pathology. Perridon teaches that high concentration of hydrogen sulfide cause severe tissue damage in the intestine. [page 2268, col. 1].
While Zhao and Juricic are silent on the cause of increase intestinal permeability, the prior arts of Dordevic´, Jowett, Kushkevych and Perridon teach that increase intestinal permeability is caused by hydrogen sulfide produced by the bacteria in the gut. Thus, one of ordinary skill in the art would have been motivated with reasonable expectation of success to treat increased intestinal permeability (leaky gut) caused by hydrogen sulfide producing bacteria as taught by the cited prior arts, by administering an effective amount of rapamycin because Zhao and Juricic teach the effectiveness of rapamycin in treating, ameliorating and improving increased intestinal permeability, decrease intestinal inflammation and significantly improved intestinal barrier function.
Therefore, claim 1 is prima facie obvious over the cited references.
Rapamycin meets the limitations of claim 8 because rapamycin is an inducer of autophagy snail inhibitor. See instant specification at page 5, line 1.
Claims 2-7 are met for the following reasons: the cited prior arts teach a method of treating a leaky gut caused by hydrogen sulfide producing bacteria by administering a snail inhibitor in an amount effective to reduce ameliorate at least one symptom or clinical sign of leaky gut caused by hydrogen sulfide producing bacteria. The combining prior arts are silent on the functional limitations of claims 2-7 but otherwise teaches a substantially identical method as claimed. As such, it is reasonable to presume that the resulting overgrowth of hydrogen sulfide producing bacteria is inherently inhibited, the snail expression, the FITC-dextran, the percentage of cells with snail localized, and the cytoplasmic localization of occluding are inherently decreased, and the paracellular localization of occluding is inherently increased. The burden is on Applicant(s) to show that this property is different from those taught by the prior art and to establish patentable differences. See MPEP 2112.
Conclusion
Claims 1-8 are rejected. No claim is allowed.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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