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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/4/2026 has been entered.
The amendment and remarks, filed 3/4/2026, are acknowledged. Claim 1 is amended. Claims 2-3 and 6 are cancelled. Claims 1, 4, and 7-10 are pending and are currently under examination.
Claim Objections Withdrawn
The objection to claims 6 and 9 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if rewritten in independent form including all of the limitations of the base claim and any intervening claims is withdrawn. The previous indication that claims 6 and 9 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims has been reconsidered based on the new art presented below.
Claim Rejections Withdrawn
The rejection of claims 1-4, 7-8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Agarwal et al (ACS Med Chem Lett, 7:51-55, 2016) is withdrawn in light of applicant’s amendment thereto.
New Claim Rejections - 35 USC § 102
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, 4, and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Honda et al (US Patent Application Publication 2014/0341921).
The instant claims are drawn to methods of treating atopy and allergic disease by administering an effective amount of a bacterium, a gene vector, composite or extract, and/or bile acid receptors FxR and/or TGR5 agonists, wherein the bacterium, the gene vector, composite or extract has 7 alpha-dehydroxylase activity, wherein the effective amount of the bile acid receptors FxR and/or TGR5 agonists is 24-36 mg/kg/day, wherein the composition induces immune-regulatory leukocytes, wherein the bacterium is Clostridium scindens, wherein the immune-regulatory leukocytes comprise a polymorphonuclear myeloid-derived suppressor cell (PMN-MDSC) and a regulatory T-cell (Treg).
Honda et al disclose methods of treating allergies such as asthma by administering a composition comprising Clostridium scindens (see paragraph 0090 and 0108). The administration can be oral or parenteral with a carrier and/or in a food composition (see paragraph 0112-0113). It is noted that while the reference is silent with respect to induction of polymorphonuclear myeloid-derived suppressor cells, administration of the same composition to the same population would necessarily result in the same outcome. Therefore, the Clostridium scindens administration disclosed by Honda would necessarily induce PMN-MDSC. It is also noted that, as discussed in the rejection under 35 USC 112b set forth below, it is not clear from the claims whether administration of bile acid receptors FxR and/or TGR5 agonists is required by the claim.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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, 4, and 7-10 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are drawn to methods of treating atopy and allergic disease by administering an effective amount of a bacterium, a gene vector, composite or extract, and/or bile acid receptors FxR and/or TGR5 agonists, wherein the bacterium, the gene vector, composite or extract has 7 alpha-dehydroxylase activity, wherein the effective amount of the bile acid receptors FxR and/or TGR5 agonists is 24-36 mg/kg/day, wherein the composition induces immune-regulatory leukocytes, wherein the bacterium is Clostridium scindens, wherein the immune-regulatory leukocytes comprise a polymorphonuclear myeloid-derived suppressor cell (PMN-MDSC) and a regulatory T-cell (Treg).
While the claims do recite a specific bacterium and a specific dose of bile acid receptors and/or TGR5 agonists, the claims also include the choice of a gene vector. The gene vector is required to have 7 alpha-dehydroxylase activity. As a gene vector would be composed of nucleotides, it would not have any enzymatic activity. The specification does not disclose any genetic material that has any enzymatic activity, let alone 7 alpha-dehydroxylase activity. The art also does not describe such genetic material.
Therefore, the specification provides insufficient written description to support the genus encompassed by the claim. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that
"applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
Adequate written description requires more than a mere statement that something is part of the invention and reference to a potential method for isolating it. The nucleic acid and/or protein itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and does 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 (1997); In re Gosteli , 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 USPQ2datl966.
Therefore, the claims do not meet the written description provision of 35 USC 112, first paragraph.
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, 4, and 7-10 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 pre-AIA the applicant regards as the invention. Claims that are not specifically mentioned below are included because they contain the issue of the parent claim.
Claim 1 is indefinite because it is not clear what components must be administered. The claim recites a specific dose of bile acid receptors FxR and TGR5 agonists and recites Clostridium scindens as the bacteria. However, the claim also uses and/or language that does not appear to require these components.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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