DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 05/18/23 was filed and entered. The submission is in compliance with the provisions of 37 CFR 1.97 and has been considered by the Examiner.
3. The listing of references in the specification is not a proper information disclosure statement (IDS) because 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office; and MPEP § 609.04(a) states "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the Examiner on form PTO-892, or by Applicant on an IDS, they have not been considered.
Objection to Specification
4. The title of the invention is objected to because of the word “improved” which should not be included in a title; see MPEP 606 and 37 C.F.R. 1.72.
Election/Restrictions
5. Applicant’s election without traverse of Group II, in the reply filed on 12/03/25, is acknowledged.
Claim Status
6. The amendment, filed 06/23/13, has been entered. Claims 1-14 are pending. Claims 15, 18 and 19 are cancelled. Claims 1-5 and 10-13 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/03/25. Claims 6-9 and 14 are under examination.
7. The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not). In the instant case, claims 16 and 17 are missing from the claim listing. Appropriate correction is required in the next correspondence in order to avoid a Notice of Non-compliance; also see 37 CRF 1.121(c) and MPEP 714.
Claim Rejections - 35 USC § 112
8. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
9. Claims 6-9 and 14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The term “improved” in claim 6 is a relative term which renders the claim indefinite. The term “improved” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In other words, to what degree of improvement and/or improvement as compared to what, is required to be included vs. excluded in the claim’s scope?
Dependent claims do not clarify the issue identified above; therefore, clarification is required to remove scope ambiguity and ascertain the metes and bounds of the claim.
Claim Rejections - 35 USC § 102
10. 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.
11. 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.
12. Claims 6, 7, 9, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bel-Rhlid et al. 2018 (US 2018/0028582).
Bel-Rhlid teach methods comprising oral administration of an effective amount of compositions comprising Lactobacillus johnsonii in combination with polyphenols, including rosmarinic acid, caftaric acid and/or chicoric acid, extracted from plants (e.g. [0013, 0019, 0027, 0033, 0039]; and Bel-Rhlid claims 1-12; meeting limitations found in instant claims 6, 7, and 14).
With regards to “…improving immune function in a subject” in claim 6; and “…wherein administering the composition increases expression of Toll like receptor 7 (TLR7) and Toll like receptor 9 (TLR9) in the subject” in claim 9; it is noted that neither limitation adds a positively recited step to the method and therefore both have been interpreted as expressions of intended results of the only positively recited step of administration; see MPEP 2111.04. Further, MPEP 2112.02 states when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated; emphasis added; see In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the applicants had merely found a new property of the compound and such a discovery did not constitute a new use. See also In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966) "While the references do not show a specific recognition of that result, its discovery by appellants is tantamount only to finding a property in the old composition." 363 F.2d at 934, 150 USPQ at 628 (emphasis in original)). Therefore, Bel-Rhlid anticipates the invention as claimed.
Claim Rejections - 35 USC § 103
13. 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.
14. 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.
15. 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.
16. Claims 6-9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bel-Rhlid et al. 2018 (US 2018/0028582) in view of Valladares et al. 2010 (Lactobacillus johnsonii N6.2 mitigates the development of Type 1 diabetes in BB-DP rats; PloS One 5(3): 1-9; e10507) and Pozzilli et al. 2006 (A new expression of diabetes: double diabetes; Trends in Endocrinology & Metabolism; 18(2): 52-57).
The teachings of Bel-Rhlid are set forth above. In addition, Bel-Rhlid teach disorders that may be treated encompass organ-limited extracellular amyloidosis such as type 2 diabetes (e.g. [0022]).
Therefore, the difference between the prior art and the invention is the use of Lactobacillus johnsonii strain N6.2.
However, Valladares teaches both genetic and environmental factors affect development of disorders such as diabetes, including gut microbiota, intestinal environment, barrier functions, and immune system responses (see page 1, introduction). Valladares teaches a general assessment of the host response to Lactobacillus johnsonii administration indicated that the microbe targets an early signaling pathway conducive to increased levels of interepithelial junction proteins and mucus secretion, while decreasing oxidative status and inflammation in the intestine (see page 2, left column). Valladares teaches oral administration of compositions comprising Lactobacillus johnsonii strain N6.2 successfully treated type 1 diabetes in a model system (e.g. see page 2, Results and Figure 4).
In addition, Pozzilli et al. teaches type 1 and type 2 diabetes are related and may co-occur in the same individual (i.e. called “double diabetes”; see abstract, introduction and Table 1). Pozzilli teach immunomodulatory treatments are appropriate for those with double diabetes (e.g. see page 55, right column).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to modify therapeutic methods comprising administering compositions of polyphenols with Lactobacillus johnsonii in general, as taught by Bel-Rhlid, by administering Lactobacillus johnsonii strain N6.2 in particular, thereby arriving at the claimed invention, in order to treat subjects with diabetes, as taught by Bel-Rhlid and Valladares. Therefore, each and every element is taught in the prior art and the combination has a beneficial result; however, the combination amounts to no more than a predictable use of prior art elements according to their established functions. The person of ordinary skill in the art would have been motivated to make the modification, with a reasonable expectation of success, because Bel-Rhlid had already taught L. johnsonii would treat type 2 diabetes; Valladares had already demonstrated Lactobacillus johnsonii strain N6.2 successfully treated type 1 diabetes and Pozzilli had already taught type 1 and type 2 were comorbid and that immunomodulatory treatments were appropriate for such patients. Therefore, the combination leads to expected results because each element performs the same function as it does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the Bel-Rhlid teaches a base method that only differs from the claimed invention by the substitution of a single component (i.e. substitution of the particular strain of Lactobacillus johnsonii administered); the substituted element (i.e. Lactobacillus johnsonii strain N6.2) was already known and was already shown to function as a therapeutic treatment for diabetes when administered to subjects in need thereof; thus, no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of substituting one bacterial strain for another with a reasonable expectation of success (i.e. the substitution of the element would lead to predictable results).
Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
17. No claims are allowed.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. 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, Dan Kolker can be reached on (571)-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
19. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARY MAILLE LYONS/Examiner, Art Unit 1645
January 13, 2026