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 the Group IV, claim 13, in the reply filed on 7/24/2026 is acknowledged.
Claims 1-11, 15 and 16 have withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/24/2026.
Claim 13 as filed on 5/23/2024 is under examination in the insntst office action.
Claim Rejections - 35 USC § 112
Claim 13 is 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 13 recites administration of the Bacillus megaterium strain of claim 1 but characteristics of this strain are not recited in the elected claim 13. The characteristics of the strain as intended for a method of administration are uncertain. The metes and bounds of the claim 13 with respect to method of treating infection cannot be determined. Moreover, strain of claim 1 comprises “one or more bacteria”. The meaning of term “strain” is narrower than the meaning of the term “bacteria”. The bacterial strain of cannot comprise several bacteria of the same species as the strain but only cells of this specific strain. Further, comparative identities of sequences genes gyrB and 16S rRNA are used for identification of bacterial species and phylogenetic analysis but these genes are not related to therapeutic effects of the specific strain.
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.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claim recites administration of the Bacillus megaterium strain MIT411to a generic human subject. The strain is a natural isolate (see published instant application US 2025/0170189 at par. 0012) or a natural product. The population under treatment is unlimited and/or generic. Thus, administration of a natural product to a generic population is considered to be a mere act of eating or a natural phenomenon.
Thus, this judicial exception is not integrated into a practical application because it is nothing more than an attempt to generally link the product of nature to a particular technological environment.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception.
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 13 is rejected under 35 U.S.C. 102 (a) (1) as being anticipated by US 2021/0145899 (Deaton et al).
The cited US 2021/0145899 (Deaton) teaches that Bacillus megaterium strain MIT411 is capable to inhibit infection (page 211, table 4), to prevent adherence of pathogens (page 212, par. 3422), to disrupt biofilms formed by pathogens (page 213, par. 3441); and is used in therapeutic compositions in methods for treating infections in humans (page 19, par. 169). The Bacillus megaterium strain MIT411 of the cited reference is the same Bacillus megaterium strain MIT411 of the instant application and claims (see published instant application US 2025/0170189 at par. 0079-0080) and comprises identical sequences of genes gyrB and 16S rRNA.
Thus, the cited method comprises one step of providing or administering the same strain to human subjects as intended to treat fungal, bacterial and yeast infections. Therefore, the cited reference is considered to anticipate claim 13.
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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kalaimathi et al (“Effectiveness of a Bacillus megaterium, as a probiotic in Salmonella typhimurium induced infection in rats”. Journal of Pharmacy Research (Mohali, India) (2015), 9(2), 177-181) in view of Edgar (Bioinformatics, 2018, 34(14), 2371-2375).
The cited reference by Kalaimathi teaches a method for treating infection by administering a probiotic culture that belongs to the bacterial species of Bacillus megaterium to infected mice.
The bacterial strain of claim 1 belongs to the species of Bacillus megaterium. The 16SrRNA is used for identifying bacterial culture on a species level; and the threshold for the same bacterial species is 97% identity (see abstract of Edgar). Thus, the bacteria in the claimed method is the same bacteria as administered by Kalaimathi.
Although the subjects under treatment in the cited method are not humans but mice, the mice are commonly used as mammalian models for applications to humans. Therefore, the cited method is an obvious equivalent of the claimed method.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERA AFREMOVA whose telephone number is (571)272-0914. The examiner can normally be reached Monday-Friday: 8.30am-5pm EST.
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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Vera Afremova
August 12, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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