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 .
Status of claims
Claims 2-4 as amended on 7/14/2025 are pending and under examination in the instant office action.
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 2 as amended remains/is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The claim 2 recites a compositions comprising 3 bacterial strains including Enterococcus faecalis GDMCC 62869, Bifidobacterium longum GDMCC 62866 and Enterococcus faecum GDMCC 62869.
All claim-recited bacterial strains are naturally occurring bacteria. The specification does not describe recombinant techniques for making and/or modifying bacteria. The representatives of the claim-recited bacterial species are commonly found in animal guts and considered to be probiotics. A compositions comprising 3 bacterial strains is a mixture of natural products. Thus, the claimed product as a whole a product of nature.
This judicial exception is not integrated into a practical application because claimed elements in combination do not add a meaningful limitation or extra-solution to the claimed product, and the claimed product as a whole is nothing more than an attempt to generally link the product of nature to a particular technological environment.
The claim does 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 § 112
Deposit
Claims 2-4 as amended remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
All claims require one of ordinary skill in the art to have access to 3 specific bacterial strains including Enterococcus faecalis GDMCC 62869, Bifidobacterium longum GDMCC 62866 and Enterococcus faecum GDMCC 62869.
Because the microorganism are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the microorganisms are not so obtainable or available, the requirements of 35 U.S.C. 112 may be satisfied by deposit of the microorganism. The specification does not disclose a repeatable process to obtain the microorganisms and it is not clear from the specification or record that the microorganisms are readily available to the public.
The rejection may be overcome by establishing that each microorganism identified is readily available to the public and will continue to be so for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer, or by an acceptable deposit as set forth herein. See 37 CFR 1.801-1.809.
If the deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or a statement by an attorney of record over his/her signature and registration number, stating that the deposit has been made under the Budapest Treaty and that all restrictions imposed by the depositor on availability to the public of the deposited material will be irrevocably removed upon issuance of the patent would satisfy the deposit requirement. See 37 CFR 1.808.
Because Guangdong Microbial Culture Collection Center (GDMCC) has acquired the status of an International Depository in accordance to the Budapest Treaty, and the deposit statement has been provided in the papers filed 7/14/2025.
But no copy of deposit receipts were provided for the record as evidence of the deposited strain viability and history of designation numbers.
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.
Claims 2-4 as amended remain/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0387439 (Shim).
The cited document teaches that probiotic bacteria belonging to Enterococcus faecalis, Bifidobacterium longum and Enterococcus faecum are known as therapeutic agents (0010) and they used for making/providing drugs treating inflammation in various subjects including cats (0024).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to provide bacteria belonging to Enterococcus faecalis in a combination Bifidobacterium longum and Enterococcus faecum with a reasonable expectation of success in therapeutic applications as intended for making drugs intended for treating inflammation in various subjects including cats.
Although the prior art is silent about specific strains as recited in the claims, the use of similar strains is considered to be a substitution of equivalents. Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments filed on 7/14/2025 with respect to the claims as amended on 7/14/2025 have been fully considered but they are not all found persuasive.
The rejection of claims under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, has been withdrawn in view of amended to the claims.
The deposit requirements has been partially met. Applicants provided a deposit statement. But applicants did not provide copies of deposit receipt (s) as evidence of strain viability and as evidence of history of strain assignment and/or various designation numbers.
With regard to claim rejection under 35 U.S.C. 101 Applicants argue that a combination of 3 claimed strains is synergistic for treatment of feline inflammatory disorders, thus, includes addition elements and is integrated into practical application.
These arguments are not found convincing because claim recites a simple mixture of 3 naturally occurring bacteria that are unmodified and are not markedly different form their natural counterparts either alone or in combination. The claimed bacteria are probiotics and they are found in gut of animals, thus, they are present in the same combination in nature. The composition with 3 bacteria is not modified, for example: by lyophilization to extend shelf life or by coating to increase its effectiveness and reduce side effects.
With regard to claim rejection under 35 U.S.C. 103 as being unpatentable over US 2022/0387439 (Shim) Applicants argue that a combination of 3 claimed strains provides for synergistic effects in treatment of feline inflammatory disorders.
The declaration by Lingling Zhao filed on 7/14/20025 states (page 2, it. 5) that the results of the analysis are presented in attachment in Appendix I . But this Appendix I is not found the papers filed on 7/14/20025.
Further, it is unclear on the record and as disclosed in as-filed specification that the claimed strains are novel strains. The copy of deposit receipts are missing to evaluate history of strain isolations and designations by accession numbers in order to establish whether the claimed strains are novel isolates or re-deposits on old prior art isolates.
Furthermore, it is noted that the scope of the showing must be commensurate with the scope of claims to consider evidence probative of unexpected results, for example. In re Dill, 202 USPQ 805 (CCPA, 1979), In re Lindner 173 USPQ 356 (CCPA 1972), In re Hyson, 172 USPQ 399 (CCPA 1972), In re Boesch, 205 USPQ 215, (CCPA 1980), In re Grasselli, 218 USPQ 769 (Fed. Cir. 1983), In re Clemens, 206 USPQ 289 (CCPA 1980). It should be clear that the probative value of the data is not commensurate in scope with the degree of protection sought by the claim. It is well recognized that synergism is a highly unpredictable result that is very dependent on the ingredients used and the amounts of each. Thus, any combination for which synergism is not clearly established would be properly rejected because non-obviousness would not have been established. For example: specification examples are based on a particular CFU amounts and/or ratio for each strain in a combination of 3 strains that is argued for synergistic effects when combined.
No claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Vera Afremova
September 29, 2025
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653