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 with traverse of Group I, Species 2 Isoflavonoid, and Species 3 Autoimmune disease in the reply filed on 11-06-2025 is acknowledged.
The traversal is on the ground(s) that it would not place an undue burden on the examiner to search the subject matter of all the claims, and the search directed to one group would likely yield results applicable to other groups. This is not found persuasive because the inventions require different search strategies and keywords, as well as separate consideration of different prior art references. There is no evidence that the distinct inventions could be searched together without undue burden, or that the search of one group would yield results applicable to other groups. Assuming arguendo, that the search did yield results applicable to other groups, there is still an undue burden on the examiner to separately consider and apply each prior art reference by writing separate rejections.
The requirement is still deemed proper and is therefore made final.
Claims 22, 23, 40 and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The restriction requirement for species 1, as set forth in the Office Action mailed on 11-06-2025 , has been reconsidered and is hereby withdrawn.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or non-statutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Rejections - 35 USC § 112
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.
Claim 5 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 is indefinite since it includes a period after Adlercreutzia and it is unclear if the language following the period is a part of the claim.
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) 1-2, 5,9,17,20, 25-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Von Maltzahn, G.A. et al., (202110137964A1; published 13-05-2021).
Regarding claims 1-2and 25, applicant has a prevention embodiment in which disease is prevented in a population in need thereof. Von Maltzahn et al., teaches a method to prevent, breast cancer in patients by administering an effective amount of one or more gut microbes and phytoestrogens. See 0111.
Von Maltzahn et al., teaches the use of probiotics for human use to “modulate immune response in the host” (page 34, paragraph 0358). Von Maltzahn et al., discloses “probiotics in combination with a glycan composition”(page 33, paragraph 0353-0355); one embodiment includes probitoic with daidzin to a subject with breast cancer” (page 5, paragraph 0111) .
Regarding claim 5 and 26, Von Maltzahn et al., teaches gut microbes Adlercreutzia and Parabacteroides species (page 23, Table 4; page 44, paragraph 0454, 0455).
Regarding claim 9 and 27, Von Maltzahn et al., teaches phytoestrogens: coumestan, isoflavanoid, isoflavanol, quercetin, daidzein, equol, and genistein (; page 12, paragraph 0216-0217; page 33, Table 7-continued).
Regarding claim 17 and 29, Von Maltzahn et al., teaches oral administration with foods and/or pharmaceuticals (page 37, paragraph 0390; page 46, paragraph 0474) , oral administration is anticipated by a finite series of methods-of-administration (page 9, paragraph 0165).
Regarding claim 20, in a preferred embodiment Von Maltzahn et al., teaches a method to decrease disease severity in humans, with effective amounts of gut microbes and/or phytoestrogens to treat breast cancer as a method to decrease disease severity (page 5, paragraph 0111).
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.
Claims 3, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Von Maltzahn, G.A. et al., (202110137964A1; published 13-05-2021).
The teachings of Von Maltzahn et al., are previously disclosed.
Although, Von Maltzahn et al., suggests treating inflammatory disease and/or autoimmune disease by administering gut microbes with phytoestrogens for inflammatory or autoimmune disease, it is not immediately envisaged .
However, in other embodiments, Von Maltzahn et al., teaches the administration of said method to “treat inflammatory bowel disease…to a subject having or at risk of inflammation or an inflammatory disorder” (page 6, paragraph 0129) and the treatment of autoimmune disorders such as Parkinson’s Disease (page 46, paragraph 0478).
One would have been motivated, based on these teaching, to treat an inflammatory disease and/or autoimmune disorder using these methods since the method results in increased secondary metabolites that reduce inflammation, and are produced from probiotic metabolization of phytoestrogens. The method further alters the population dynamics of gut microbes towards a population that reduces inflammatory agents, therefore preventing tissue damage and/or inflammatory disease resulting from chronic tissue inflammation.
Therefore, it would have been obvious to one of ordinary skill in the art at the effective date of filing, to incorporate the methods of Von Matlzahn et al., to treat inflammatory and/or autoimmune disorders, since Von Matlzahn et al., teaches prevention of disease (breast cancer) and envisages treating inflammatory disorders (inflammatory bowel disease) and/or autoimmune disorders (Parkinson’s disease) using gut microbes and phytoestrogens in a glycan composition. Since the prior art teaches methods to prevent and/or decrease disease in human patients, it would have been obvious to use the same methods to treat inflammatory disease and/or autoimmune disease .
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ENUSHA KARUNASENA whose telephone number is (571)272-3972. The examiner can normally be reached Monday-Friday 7:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653