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 Species 1 (claims 1-12) a food composition, and Species 2 (claims 1,11, and 12) a fermented culture supernatant of a Bacillus velezensis strain, a concentrate thereof, a dried product thereof, in the reply filed on 05/15/2026 is acknowledged.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/15/2026.
Claim Status
Claims 11 and 12 are pending and under examination. Claim 13 is cancelled.
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 11 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to administering a natural product without significantly more. The claim(s) recite(s) a microorganism comprising isolated, Bacillus velezensis, a bacterial agent, This judicial exception is not integrated into a practical application because only this naturally occurring, isolated microorganism and its intended use is claimed. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only the isolated Bacillus velezensis and its intended use, is claimed.
With regards to Step 1, claims 11 and 12 is considered to be in a statutory category of process.
With regards to Step 2A, prong one, claims 11 and 12 encompasses a method of administering a microorganism comprising an isolated Bacillus velezensis. Thus, claims 11 and 12 are generally directed to a naturally occurring microorganism and its inherent functional capabilities. It is indicated in the Specification of the instant application that the bacterial strain is isolated and purified from the traditional Korean fermented kimchi. Thus, Bacillus velezensis is a natural bacterial strain that has been isolated from its natural environment. There is nothing to indicate that the isolated Bacillus velezensis is in any way different from its naturally occurring counterpart (e.g. it is not genetically modified to add/delete a gene). The isolation of an organism from the natural environment without any further alteration does not render the organisms non-natural.
With regards to Step 2a, prong two, claims 11 and 12 do not recite any elements in addition to the isolated Bacillus velezensis and its intended use. The claims are directed to a method, however recite the use a natural composition and its natural traits. Recitation of the intended use of application to prevent or reduce obesity does not in any way change the natural structure or inherent functionality of the isolated Bacillus velezensis. As such, there is no additional element in claims 11 and 12 that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the isolated natural Bacillus velezensis, such that the claims as a whole are no more than a drafting effort designed to monopolize the exception.
With regards to Step 2b, claims 11 and 12 do not recite any elements in addition to the isolated Bacillus velezensis and its intended use. The claims are directed to a method of use of the natural organism with its natural traits. Recitation of the intended use of application does not in any way change the natural structure or inherent functionality of the isolated Bacillus velezensis. As such, the claims do not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
For the forgoing reasons, the claims 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.
Claim(s) 11 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hee et al., New Halophilic Bacillus Polyfermenticus Strain KMU01 Useful For Producing Salt-tolerant Gamma-glutamyl Transpeptidase Useful In Food Composition E.g. Fermented Food Including Sausage, Bread, Chocolate, Candy, Confectionery Or Beverage (*WO 2020004809 A1; Published 2020-1-02) and evidenced by Heo, S. et al., Functional Annotation Genome Unravels Potential Probiotic Bacillus velezensis Strain KMU01 from Traditional Korean Fermented Kimchi. Foods. 2021; (10:563). pp 1-14.
*US PG Pub. 20210371830 A1 is the English language equivalent, for reasons of translation, this document is used as representative of the disclosure of WO 2020004809 A1.
For purposes of reference: it is noted that Bacillus velezensis is identified in the instant application as Bacillus velezensis KMU01, which was previously identified as Bacillus polyfermenticus KMU01 KTCTC11751BP as described in the Specification of instant application, also by Heo et al., (page 4 of 14, Section titled ‘3.1 Genetic Identification of Bacillus velezensis KMU01’), and also as Bacillus polyfermenticus KMU01 KTCTC11751BP by Hee, et al., in WO 2020004809 A1.
Regarding claims 11 and 12, Hee et al., discloses a method of providing health functional food and/or food compositions comprising a culture obtained from culturing Bacillus velezensis strain KMU01 (KTCTC11751BP) (page 2, paragraphs 0021-0022) producing gamma-glutamyl transpeptidase which reduces obesity contributing factor(s) of inflammation and lowered lipids in human tissues, as evidenced by Heo et al., (page 10 of 14, paragraph 1).
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
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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