DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-8 are currently pending.
Election/Restrictions
3. Applicant’s election without traverse of Lactiplantibacillus plantarum for the species in the reply filed on February 20, 2026 is acknowledged.
4. Claims 1-8 are examined on the merits in regards to the elected species.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
5. Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin (CN 110734869 A – English translation).
This reference teaches a method for increasing the expression of autophagy-related genes by administering Lactobacillus plantarum (which is now reclassified as Lactiplantibacillus plantarum) to a subject. The reference teaches that increasing the expression of the gene increases autophagy in the subject. The reference teaches that the bacteria can be active or inactive (dead) (see pages 2 and 6 and claim 1, 3, and 5).
The reference does not specifically teach that induction of autophagy is in the intestine, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
6. Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lu (Inflamm Bowel Dis. (August 2020 – published online March 2020), vol. 26, no. 8, pp. 1199-1211).
This reference teaches that Lactobacillus plantarum (which is now reclassified as Lactiplantibacillus plantarum) induces autophagy in the intestine. The reference teaches that a concentration of 109 (1 X 109) is useful for inducing autophagy. The reference teaches that the bacteria are administered to subjects (see page 1200, first and third paragraph and Discussion section).
7. Claim(s) 1-5, 7, and 8 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toshimitsu (Nutrients (2020 – published online January 2020), vol. 12, no. 374, 14 pages).
This reference teaches administering a composition comprising 5 X 109 heat killed Lactobacillus plantarum (which is now reclassified as Lactiplantibacillus plantarum) to healthy subjects (see sections 2.2 and 2.3). The reference does not teach that the administration of the bacteria induces autophagy. However, applicant’s specification defines a subject in need of the induction of autophagy as any healthy subject (see paragraph 42). Thus, the reference teaches administering the same composition as claimed to the same subject as claimed. Therefore, the induction of autophagy would inherently have to occur in the reference method if applicant’s invention functions as claimed. Consequently, the reference is considered to properly anticipate the claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
8. Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (CN 110734869 A – English translation) in view of Toshimitsu (Nutrients (2020 – published online January 2020), vol. 12, no. 374, 14 pages).
The teachings of Lin are discussed above. The reference does not specifically teach administering the concentrations of bacteria claimed. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” In addition, Toshimitsu teaches that concentrations of 5 X 109 of heat killed L. plantarum are useful for administration to subjects (see abstract). Varying the concentration of an active within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the bacteria produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
The reference does not specifically teach that the bacteria are inactivated by heat killing. However, this means for inactivating bacteria is known in the art as demonstrated by Toshimitsu. Thus, the artisan would be motivated to use this well known procedure to produce the inactivated bacteria taught by Lin.
9. Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lu (Inflamm Bowel Dis. (August 2020 – published online March 2020), vol. 26, no. 8, pp. 1199-1211).
The teachings of Lu are discussed above. The reference does not specifically teach administering the concentrations of bacteria claimed. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Varying the concentration of an active within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the bacteria produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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