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 1 claims 10-22; Species 1 applicant elects inositol; Species 2, applicant elects polyphenol; Species 3, applicant elects coumesterol, Species 4, vitamin B, Species 5, inflammatory bowel disease; Species 6, for (6A) inositol and for (6B) polyphenol in the reply filed on May, 01, 2026 is acknowledged. Claims 14 and 21 are withdrawn as they do not read on the elected species of polyphenol.
Claims 14, 21, and 24-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 May, 01, 2026.
The restriction requirement Species 3 (Claims 13 and 20) and Species 5 (Claim 16), as set forth in the Office action mailed on March 05, 2026, has been reconsidered and is hereby withdrawn.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 nonstatutory 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 Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 10-13,15-20 and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claim(s) recite(s) a method to prevent and/or reduce a pathological condition, where the method enhances growth of Faecalibacterium prausnitzii in the microbiome of humans by administering at least one of inositol, erythritol or sorbitol. This judicial exception is not integrated into a practical application because the method only consists of natural product(s) which are consumed orally to enhance a naturally existing microbial population of F. prausnitzii. The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only naturally occurring sugar alcohols (inositol, erythritol, or sorbitol) and/or polyphenol(s) and their general administration, orally, to enhance a natural population of F. prausnitzii-- as the intended use, is claimed.
With regards to Step 1, although the claim is directed to a process: the method is simply administering the naturally produced compounds of inositol, erythritol, or sorbitol, to enhance a natural microbe, of the human flora, F. prausnitzii, in claims 10 and 17 and dependent claims 11-13, 15,16, 18-20, and 22 which is a method without a patient population. Thus, the claim is directed to the judicial exception itself, which are naturally occurring products of nature.
With regards to Step 2A, prong one, claims 10 and 17,dependent claims 11-13, 15,16, 18-20 and 22 are directed to a method of generally administering inositol, erythritol, or sorbitol, with a polyphenol (coumesterol or quercetin), to enhance a natural microbe of human flora, F. prausnitzii;
Although the claims recite a method, the claims are drafted in such a manner, that the claim is directed to the judicial exception itself. See MPEP 2106.04 ( c ).
Regarding claim 10 the broadest embodiment reads on eating berries (see Regnat et al., and Sanz et al., which demonstrates that berries inherently contain inositol); since applicant has not claimed a population and F. prausnitzii is naturally occurring in the human body.
Regarding claim 17, although the claim is directed to various disorders, the broadest embodiment is directed to aging which is a natural occurrence in all humans.
Regarding claims 11 and 18, although the claim(s) is directed towards certain human subjects, the broadest embodiment is directed to humans without a patient population.
Regarding claim 12, the broadest embodiment reads on eating berries (containing inositol, as previously referenced above, and quercetin as referenced by Cady et al) containing B vitamins (see Roxana et al.).
Regarding claim 13, the broadest embodiment of the claim(s)reads on eating berries which teaches that berries inherently contain polyphenol and sugar alcohol (see Cady et al., (polyphenols), Godswill et al., and Sanz et al., (sugar alcohols), and Roxana et al., (B vitamins)), since applicant has not claimed a population and polyphenols comprising coumestrol or quercetin are naturally occurring in a range of vegetative foods.
Regarding claim 15, the broadest embodiment of the claim reads on eating berries which is a natural method of oral administration to a subject.
Regarding claim 16, although the claim is directed towards various pathological conditions, the broadest embodiment is directed to aging, which is a natural process for living organisms.
With regards to Step 2a, prong two, claims 10 and 17, 11-13, 15, 16, 18-20, and 22 do not recite any elements in addition to the natural components found in natural vegetative foods, including: inositol, erythritol, or sorbitol (as previously evidenced by Godswill et al., and Regnat et al.,), and/or the composition further comprising natural polyphenol(s) (as previously evidenced by Cady et al.,), or a vitamin (page 62, Table 1, as evidenced by Roxana et al., ) that are administered to enhance a natural microbe, in human flora, F. prausnitzii. The claims are directed to a method of use, however there are no additional elements in claim 10 and 17, 11-13, 15,16, 18-20 and 22 that applied or uses the judicial exception in some other meaningful way that is a practical application, beyond generally linking the use of the judicial exception to enhance F. prausnitzii, in humans, and there is no specific patient population, such that the claim(s) as a whole is no more than a drafting effort designed to monopolize the exception. Accordingly, the claims do not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
With regards to Step 2b, claim 10 and 11-13, 15-20 and 22 there are no new steps that add more than the judicial exception. The claim(s) recite the additional elements of administering naturally occurring polyphenol(s) which are quercetin and/or coumesterol to prevent and/or reduce a severity of a pathological condition in a subject – the recitation of conventional metabolites produced and/or consumed naturally from fruits and/or vegetables known to enhance a natural microbe in human flora, do not amount to significantly more than the judicial exception. The claims are directed to a method of use, however there is no change in the natural structure or inherent functionality of the composition and/or administration which are routine and conventional, including in the prior art as evidenced by:
Godswill, A.C. et al., Current Developments In Sugar Alcohols: Chemistry, Nutrition, And Health Concerns Of Sorbitol, Xylitol, Glycerol, Arabitol, Inositol, Maltitol, And Lactitol. International Journal of Advanced Academic Research. 2019; (5:11). pp. 1-33,
Regnat, K. et al., Erythritol as sweetener—wherefrom and whereto? Applied Microbiology and Biotechnology. 2018; (102). pp. 587-595,
Cady, N. et al. Beyond Metabolism: The Complex Interplay Between Dietary Phytoestrogens, Gut Bacteria, and Cells of Nervous and Immune Systems. Frontiers in Neurology. 2020; (11). pp. 1-15,
Roxana et al., The Vitamin Content of Fruits. Annals of the Constantin Brancusi University of Targu Jiu, Engineering Series. 2019. (4); pp 59-65.
As such, the claims do not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
Regarding claim16, the dependent claim further recites pathological conditions including the broadest embodiment aging, which is a natural process for living organisms and therefore the limitation(s) do not integrate the judicial exception into a practical application and/or specific population in need thereof.
Summarily, the claim limitations generically claim the agents and prevention and/or reduction of a pathological condition. However, they do not integrate into a practical application since they do not use any more than the natural compositions of sugar alcohol and/or polyphenol(s) which are naturally present in fruits and/or vegetables and resultingly, naturally consumed though oral administration. Accordingly, the claims do not recite anything more than the judicial exception and are directed to a method of general use of a product of nature without significantly more.
For the forgoing reasons claims 10, 11-13, 15-20 and 22 , are not deemed to encompass patent eligible subject matter under 35 USC § 101.
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.
Claims 10-13,15-20 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Culler, S.J. et al., (US20210038654A1; published 2021-02-11) as evidenced by Cady, N. et al. Beyond Metabolism: The Complex Interplay Between Dietary Phytoestrogens, Gut Bacteria, and Cells of Nervous and Immune Systems. Frontiers in Neurology. 2020; (11). pp. 1-15 and Godswill, A.C. et al., Current Developments In Sugar Alcohols: Chemistry, Nutrition, And Health Concerns Of Sorbitol, Xylitol, Glycerol, Arabitol, Inositol, Maltitol, And Lactitol. International Journal of Advanced Academic Research. 2019; (5:11). pp. 1-33 and Sanz M.L. et al., Inositols and carbohydrates in different fresh fruit juices. Food Chemistry. 2004; (87); pp.325-328) and Kumar, R. et al., Health Benefits of Quercetin. Defence Life Science Journal. 2017. 2:2; pp 142-151 and Roxana et al., The Vitamin Content of Fruits. Annals of the Constantin Brancusi University of Targu Jiu, Engineering Series. 2019. (4); pp 59-65.
Regarding claim 10, Culler, et al., discloses multiple microbe mixes consisting of Faecalibacterium prausnitzii to treat and/or reduce pathological conditions in a subject with tumors resulting from cancer to promote immunotherapy efficacy (page 100-101, claims 1 and 5); in a preferred embodiment, metabolomic analysis demonstrated increased inositol in therapy responder groups (page 33, paragraph 0421 including Table 19). Additionally, purified populations of bacterial cells used in the composition were introduced with formulations containing fruits and/or juices containing raspberry, blueberry, blackberry, cranberry, and strawberry fruits (page 19, 0314) which naturally contains inositol, as evidenced by Godswill et al., (page 8, Section 2.2 -2.2.8) and in fruit juices, as evidenced by Sanz et al., (page 328, Table 3) .
Regarding claim 11, Culler et al., discloses in a preferred embodiment, treatment of human adult patients (Example 7, page 35, paragraph 0431) provided immunotherapy for cancer, and resulting differences and/or changes in populations of F. prausnitzii ( Table 34-cont., 63 page ) in respondent and non-respondent cohorts compared to controls.
Regarding claims 12, 15, 16, 17, 18, 19 and 22 Culler et al., discloses metabolomic analysis of fecal samples of immunotherapy respondent and non-respondent cohorts (Table 20) and identify microbial degradation of dietary polyphenols produces benzoate metabolites (page 34, paragraph 0426) and in some preferred embodiments discusses the use of formulations containing fruits and/or juices containing raspberry, blueberry, blackberry, cranberry, and strawberry fruits (page 16, 0282) which naturally contain the polyphenol quercetin, as evidenced by Cady et al., (page 10, paragraph 2) and in juices as evidenced by Kumar, R.et al(page 144, paragraph 1) along with inositol as evidenced previously in fruit by Godswill et al., (page 8, Section 2.2 -2.2.8) and juices as evidenced by Sanz et al. (claims 12 and 19). Also, Culler et al., discloses a freeze-dried composition with formulations (page 18 paragraphs 0305-0306) of microbial mixes containing F. prausnitzii, media components, which contain inositol (page 18, 0305), that are administered orally (page 102, claim 8) (claims 15 and 22). Culler et al., further discloses intestinal microbiota facilitate inflammatory conditions, responses, and modify T-cell response to tumors (claim 16) along with immune checkpoint inhibitor efficacy (page 1, 0004), F. prausnitzii was introduced and/or measured in subjects for effective anti-inflammatory therapy in humans (claims 17 and 18) (page 100-101, claims 1,5,and 7).
Regarding, claims 13 and 20 Culler et al., discloses in some preferred embodiments of bacterial preparation and administration, bacteria are prepared for use in therapeutic compositions, formulations, or pharmaceuticals in nutrient media with fruits and/or juices containing raspberry, blueberry, blackberry, cranberry, and strawberry fruits (page 16, 0282) which naturally contain the polyphenol, quercetin-- as evidenced by Cady et al., (page 10, paragraph 2).
Conclusion
No claims are deemed allowable.
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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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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