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 .
Election/Restrictions
Applicant’s election without traverse of group I (claims 1-9), drawn to a method of controlling a tight junction between epithelial cells of an animal, in the reply filed on February 12th, 2026 is acknowledged. The requirement is deemed proper and is therefore made FINAL.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. In a written response, the applicant elected Species I (claim 2). In a phone call on March 26th, 2026 at 2:46 PM (United States Eastern Time) the applicant, represented by attorney of record Zbigniew Sawicki (registration No. 30214), elected Species III (claim 3), such that Species IV (claim 5) would be withdrawn. Claim 4 is also withdrawn as being drawn to non-elected species II.
Claims 1-3, and 6-9 are pending and were examined on the merits.
Information Disclosure Statement
The information disclosure statement filed February 13th, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because Non-Patent Literature Document Cite No 5 (Huang, Q. et al. Animal Nutrition 2018, 4, 137-150) has illegible text, noticeable in its reference list. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
A legible copy of Huang, Q. et al. Animal Nutrition 2018, 4, 137-150 has been attached and cited on the PTO-892 form.
Claim Objections
Claim 1 is objected to because of the following informalities: "25-100ppm" should be revised to "25-100 ppm" for proper spacing between numbers and units. Appropriate correction is suggested.
Claim objected to because of the following informalities: the term "Glycine max" should be italicized because it is a taxonomic genus-species name. Appropriate correction is suggested.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The phrase “epithelial cells of an animal” is understood by the examiner as epithelial cells comprising a living animal, not epithelial cells isolated from an animal. Dependent claims 2, 3, and 6-9 are understood by the examiner as reciting the method of independent claim 1 with (a) further limitation(s) recited in the dependent claim. Therefore, the full enablement of the limitations of claims 2, 3, and 6-9 is dependent on the full enablement of the invention according to the limitations recited in claim 1.
Claim Rejections - 35 USC § 112
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 1-3, and 6-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of increasing the relative abundance of certain transmembrane proteins in an animal, by providing the animal with a feed containing polyphenols from botanical extracts comprising green tea extract and Glycine max extract, where the polyphenols comprise epigallocatechin gallate, catechin, epigallocatechin, and genistein, does not reasonably provide enablement for a method of controlling a tight junction between epithelial cells of an animal, increasing transmembrane proteins between epithelial cells thereby minimizing passage of macromolecules between epithelial cells, by providing the animal with a feed containing polyphenols from botanical extracts comprising green tea extract and Glycine max extract, where the polyphenols comprise epigallocatechin gallate, catechin, epigallocatechin, and genistein. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of controlling a tight junction between epithelial cells of an animal with a monogastric intestinal system, that increases transmembrane proteins between epithelial cells thereby minimizing passage of macromolecules between epithelial cells, by providing the animal with a feed containing polyphenols from botanical extracts comprising green tea extract and Glycine max extract, where the polyphenols comprise epigallocatechin gallate, catechin, epigallocatechin, and genistein. Thus, the claims taken together with the specification imply that providing feed comprising epigallocatechin gallate, catechin, epigallocatechin, and genistein from green tea and/or Glycine max extracts to an animal with a monogastric intestinal system increases transmembrane protein levels between the epithelial cells thereby minimizing passage of macromolecules between the epithelial cells of the animal.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Rao et al. (Biochem J 2002, 368 (2) 471-481) recites "An oxidative-stress-induced decrease in transepithelial electrical resistance was associated with a redistribution of occludin—ZO-1 and E-cadherin—β-catenin complexes from the intercellular junctions. Genistein, a tyrosine kinase inhibitor, prevented the oxidative-stress-induced decrease in resistance and redistribution of protein complexes" (Abstract); however, these results were obtained through experimentation on a Caco-2 cell monolayer, not an animal as instantly claimed in claim 1.
Watson et al. (Am J Physiol Gastrointest Liver Physiol 2004, 287, G954 –G961) recites "The green tea polyphenol (−)-epigallocatechin gallate (EGCG) has immunosuppressive properties, and we hypothesized that it would ameliorate the increased epithelial permeability induced by IFN-γ, IL-4, and/or EPEC. EGCG, but not the related epigallocatechin, completely prevented the increase in epithelial (i.e., T84 cell monolayer) permeability caused by IFN-γ exposure as gauged by transepithelial resistance and horseradish peroxidase flux; EGCG did not alleviate the barrier disruption induced by IL-4 or EPEC" (Abstract); moreover, these results were obtained through experimentation on a T84 cell monolayer, not an animal as instantly claimed in claim 1.
Bianchi et al. (Nutrients 2019, 11 (10), 2271) recites (+)-catechin increasing the expression of tight junction protein CL-7. This result was obtained using a colonic cell culture model, not an animal, as instantly claimed (Abstract; instant claim 1).
Shigeshiro et al. (Journal of Functional Foods 2013, 5 (2), 949-955) recites the effects of the polyphenols hesperetin, quercetin, curcumin, and naringenin on mice with dextran sulphate sodium (DSS)-induced colitis (Introduction, paragraph 6). Hesperetin; but not quercetin, curcumin, or naringenin; significantly decreased DSS-induced colonic epithelial permeability in mice (subheading 3.2), i.e. permeability to FITC-labeled dextran with a molecular weight of 4,000 Da (FD-4) (subheading 2.4). Quercetin and naringenin significantly increased occludin protein density in the colon above that of the untreated DSS group, but curcumin and hesperetin did not (subheading 3.3). Naringenin significantly increased JAM-A protein density in the colon above that of the untreated DSS group, but quercetin, curcumin, and hesperetin did not (subheading 3.3). None of the polyphenols used in this study significantly increased Claudin-3 protein density in the colon above that of the untreated DSS group (subheading 3.3). Shigeshiro et al. further recite "The present study did not reveal the molecular mechanisms underlying the protective effects of polyphenols on the impairment of TJ [tight junction] structure induced by DSS administration" (Discussion, paragraph 4).
Since the relationship between polyphenol molecular interactions, colonic epithelial permeability to macromolecules, and colonic tight-junction protein density in a subject animal remains largely unsolved, means for controlling a tight junction between epithelial cells by providing an animal with feed comprising the polyphenols epigallocatechin gallate, catechin, epigallocatechin, and genistein to increase transmembrane protein levels between the epithelial cells thereby minimizing passage of macromolecules between the epithelial cells of the animal, is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high. Shigeshiro et al. studied the effects of different polyphenols on both colonic permeability and the density of specific tight junction transmembrane proteins in the colons of subject animals.
Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided an increase in the relative abundance of certain tight junction transmembrane proteins in broilers (broiler is broadly understood as a breed of chicken) from the dietary administration of a blend of green tea extract and Glycine max extract comprising epigallocatechin gallate (EGCG), catechin, epigallocatechin, and genistein (paragraphs [0041] - [0043]). However, the specification does not provide that the increase in certain tight junction transmembrane proteins occurred in epithelial tissue, and that there was a corresponding decrease in the permeability of the epithelial tissue to macromolecules.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Rao et al., Watson et al., Bianchi et al., and Shigeshiro et al. and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to control a tight junction between epithelial cells of an animal with a monogastric intestinal system, increasing transmembrane proteins between epithelial cells thereby minimizing passage of macromolecules between epithelial cells, by providing the animal with a feed containing polyphenols from botanical extracts comprising green tea extract and Glycine max extract, where the polyphenols comprise epigallocatechin gallate, catechin, epigallocatechin, and genistein.
Therefore, one skilled in the art could not practice the invention commensurate in the scope of the claims without undue experimentation.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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