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 III, claims 17-18 and 22-29 in the reply filed on October 31, 2025 is acknowledged.
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.
1. Claims 17-18 and 22-29 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 treating gastrointestinal disease, does not reasonably provide enablement for prevention of gastrointestinal disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Facts that should be considered in determining whether a specification is enabling, or if it would require an undue amount of experimentation to practice the invention include: (1) the quantity of experimentation necessary to practice the invention, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. See In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1403 (Fed. Cir. 1988). The Federal Circuit has noted, however, that only those factors that are relevant based on the facts need to be addressed. See Enzo Biochem. Inc. v. Calgene, Inc. 188 F.3d 1362, 1371, 52 USPQ2d 1129, 1135 (Fed. Cir 1999).
Dresden (Medical News today) (https://www.medicalnewstoday.com/articles/323072.php) set forth that “At present there is no cure for Crohn’s disease. Doctors do not fully understand what causes the condition, which complicates the search for a cure.” (See page 1).
Harvard Health Publishing (https://www.health.harvard.edu/a_to_z/crohns-disease-a-to-z) set forth that “There is no way to prevent Crohn’s disease.” (See page 3).
Gaiger et al (US Publication 2008/0241268) set forth that “Cancer and leukemia are significant health problems in the United States and throughout the world. Although advances have been made in detection and treatment of such diseases, no vaccine or other universally successful method for prevention or treatment of cancer and leukemia is currently available. (Emphasis added; see summary).
Tanaka et al (US Patent Number 7,253,333) set forth that cancer has a multi-gene etiology, and largely dependent on environmental factors. Thus, it is impossible to prevent a disease by controlling a single factor. (See paragraph 2).
Keogh et al (US Publication 2006/0094649) set forth an overview of current cancer prevention approaches, and the difficulties associated with each one. (See Table 1).
Given the lack of guidance, lack of working examples, state of the prior art recognizing no prevention is possible, and the unpredictable nature of the invention, one of skill in the art would be forced into excessive experimentation in order to practice the instantly claimed invention.
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.
2. Claim(s) 17-18 and 22-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pennala et al.
The claims are directed to a method of preventing or treating a gastrointestinal disorder and/or enhancing gastrointestinal health, and/or reducing gastrointestinal permeability, wherein said method comprises administering an effective amount of a composition comprising a microorganism cultivated on or with lignocellulosic hydrolysate, to a patient in need thereof.
Pennala et al (US Publication 2017/0119831) disclose of compositions comprising microorganisms cultivated in medium comprising lignocellulose hydrolysate. (See claim 1 and 5). Pennala et al further disclose of administering the composition for the treatment of pathogens infecting the human digestive tract. (See claims 24-27). Pennala et al further disclose that E. coli pathogens are the major cause of weaning diarrhea. (See paragraph 0004). Pennala et al further disclose that the microbial biomass comprises 0.001-20% by weight. (See paragraph 0243). Pennala et al further disclose that the microorganism is Candidia. (See paragraph 0073).
Accordingly, Pennala et al disclose of each and every limitation of the instantly filed claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark NAVARRO whose telephone number is (571)272-0861.
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/ALBERT M NAVARRO/Primary Examiner, Art Unit 1645 November 13, 2025