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 with traverse of Invention III (claims 21-24) in the reply filed on 06/12/2026 is acknowledged. The traversal is on the following grounds:
that all pending claims in the application can and should be examined without a serious search burden; and
that Groups III and IV are substantially identical with the only difference being the purpose of the disclosed methods and examination for Group III can effectively be used to predict the inventive step of Group IV without imposing an excessive examination burden.
Applicant’s arguments have been fully considered but are not sufficient to overcome the requirement for Unity of Invention.
Applicant’s first argument is not found persuasive because the instant application is a § 371 National Stage Entry. A finding of serious search burden is required for Restriction in applications filed under 35 U.S.C. § 111(a)(MPEP § 800). The consideration of Unity of Invention is distinct from § 111(a) restriction practice and a Unity of Invention requirement is necessary regardless of search burden.
Applicant’s second argument is not found persuasive because, as discussed above, the present application is constrained by the rules for Unity of Invention. Accordingly, the requirement has been made for compliance with the requirements for Unity of Invention and without consideration of examination burden. And to the extent that the methods of Group III and IV are related, according to 37 CFR 1.475(d), if multiple uses are claimed, the first invention of the category first mentioned in the claims is the main invention. Accordingly, “methods of prolonging lifespan” is the main invention and “methods of reducing fat” lack Unity with this invention a priori.
For at least these reasons, the requirement is still deemed proper and is therefore made FINAL.
Claims 7-8, 11-16, 17-20, and 25-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 21-24 are directed to the elected invention and have been examined on their merits.
Priority
The present application is a § 371 National Stage Entry of PCT/CN2022/135531 (filed on 11/30/2022).
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 06/25/2024 and 06/12/2026 are in compliance with the provisions of 37 C.F.R. 1.97. All references cited in these IDSs have been fully considered.
Specification
The specification is objected to for the following reasons:
[0110], [0112] unitalicized taxonomic names. In general, the names of taxonomic genera and species should be italicized. Unitalicized taxonomic names are found in paragraphs [0110], and [0112];
Table 2 contains a misspelling of the word “length”;
[0117] erroneously refers to the results of FIG. 1 instead of FIG. 2;
[0120] erroneously refers to the results of FIG. 2 instead of FIG. 3;
[0123] erroneously refers to the results of FIG. 3 instead of FIG. 4;
[0125] erroneously refers to the results of FIG. 4 instead of FIG. 5;
[0129] erroneously refers to the results of FIG. 5 instead of FIG. 6;
[0133] erroneously refers to the results of FIG. 6 instead of FIG. 7;
[0135] erroneously refers to the results of FIG. 7 instead of FIG. 8;
[0139] erroneously refers to the results of FIG. 8 instead of FIG. 9;
[0140] erroneously refers to the results of FIG. 9 instead of FIG. 10;
[0142] erroneously refers to the results of FIG. 10 instead of FIG. 11.
Appropriate correction is required.
Claim Interpretation
Throughout the claims, the taxonomic name Limosilactobacillus reuteri is recited. For the purpose of examination, this taxonomic name has been interpreted to be synonymous with Lactobacillus reuteri. This interpretation is consistent with the reclassification of this bacterial species as demonstrated by applicant’s preliminary amendment to the claims and specification to replace “Lactobacillus” without “Limosilactobacillus” throughout.
Claim 22 recites an accession number. Accession numbers are arbitrary identifiers assigned to deposited microorganisms. Accordingly, these identifiers do not impart any meaningful structural limitations on the claims. That is to say, a Limosilactobacillus reuteri A21041 which is deposited with GDMCC under No. 62832 would be indistinguishable from the same strain deposited under a different accession number or not deposited at all. Thus, for the purposes of examination, the method has been examined for teachings or suggestions to use L. reuteri A21041 regardless of whether the prior art teaches the specific accession number.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 22 is rejected under 35 U.S.C. 112(a), as failing to comply with the enablement requirement.
The claim contains 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.
The specification lacks complete deposit information for the deposit of Limosilactobacillus reuteri A21041, said strain being deposited on September 23, 2022, in the Guangdong Microbial Culture Collection Center under deposit number GDMCC No. 62832.
Because it is not clear that the properties of these strains are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of this specific strain, a suitable deposit for patent purposes is required.
It is not clear whether this deposit was made under the provisions of the Budapest Treaty.
If the deposit has been made under the provisions of the Budapest Treaty, the deposit requirement may be fulfilled by filing an affidavit or declaration by applicants or assignees or a statement by an attorney of record who has authority and control over the conditions of the deposit over his or her signature and registration number averring that:
the deposit was made under the Budapest treaty and “all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent”.
This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring that:
“during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request”;
“all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application”;
“the deposits will be maintained in a public depository for a period of at least thirty years from the date of the deposit or for the enforceable life of the patent or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest”; and
“the deposits will be replaced if they should become non-viable or non-replicable”.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR § 1.801-1.809 for further information concerning deposit practice.
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.
Claim 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duan et al. (CN 114711429 A; English Machine Translation).
Duan et al. (hereinafter Duan) teaches that with the aging problem becoming more serious, bone diseases such as osteoporosis and bone loss have become a serious public health problem which impairs human health (p. 2, par. 6). Specifically, Duan teaches a Lactobacillus reuteri strain VHPribo E18 which can reduce the levels of mouse serum TNF-α, IFN-γ, and IL-1β inflammatory factors and reduce bone loss (p. 3, par. 1).
Regarding claim 21, Duan teaches a method of administering a liquid comprising the probiotic bacterial liquid by intragastric administration (p. 7, par. 8). Duan teaches that the method is for administering probiotics to delay aging, prevent and/or treat osteoporosis (p. 2, par. 6-7).
Accordingly, Duan teaches a method for prolonging lifespan and resisting aging comprising administering Limosilactobacillus reuteri to a subject in need.
With respect to the composition being an effective dosage, because Duan teaches administration of 0.2 mL/ 10 g (Examples 2 and 3) and because this dosage elicited the anti-aging effect, it is considered that Duan’s dosage is an effective dosage. Additionally, because the subjects received the therapy, they are considered to be a subject in need.
For at least these reasons, Duan anticipates the instant claim.
Claim Rejections - 35 USC § 103
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 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.
Claims 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Duan et al. (CN 114711429 A; English Machine Translation).
The teachings of Duan are set forth above and applied herein. Duan is found to anticipate claim 21.
Regarding claim 23, as discussed above, Duan teaches a method of administering Limosilactobacillus reuteri for the purpose of prolonging lifespan and resisting aging. Duan differs because it teaches a dose of 0.2 mL/ 10 g in a mouse but does not teach a dosage of 0.02-0.04 g/kg body weight for humans.
Nonetheless, a person having ordinary skill in the art could have arrived at this dosage as a result of routine optimization.
Duan renders obvious the use of the method in humans by teaching that the invention is intended to address the problem of aging in humans (p. 2, par. 6-7). Accordingly, when formulating composition used in the method, a person having ordinary skill in the art would have been expected to routinely experiment with varying amounts of Limosilactobacillus reuteri in order to arrive at a method which effectively prolongs lifespan and resists aging when administered to a human. There would have been a reasonable expectation of success because the modification merely requires altering the concentration of a single component in order to arrive at an effect previously known in the art. 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 (MPEP § 2144.05(II)(A)). There is no evidence of record that the recited range is critical.
For at least this reason, claim 23 is obvious over Duan as a result of routine experimentation.
Claims 21 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Duan et al. (CN 114711429 A; English Machine Translation) in view of Ruggiero (US 2021/0401731 A1).
The teachings of Duan are set forth above and applied herein. Duan is found to render obvious claims 21 and 23.
Regarding claim 24, as discussed above, Duan teaches a method of prolonging lifespan and resisting aging by administering Limosilactobacillus reuteri.
Duan’s methods involve the intragastric administration of the composition (Examples 2 and 3). Accordingly, Duan differs because it does not teach that the administration is “oral administration”.
Nonetheless, Ruggiero teaches an anti-aging formulation comprising a first microbial blend, a second microbial blend, chondroitin sulfate, vitamin D3, vitamin E, astragalus, and resveratrol (abstract). Ruggiero teaches that the first microbial blend can comprise one or more Lactobacillus species from a list which comprises Lactobacillus reuteri ([0016]). Ruggiero teaches that the Lactobacillus component may enhance telomerase stimulation, thereby causing anti-aging effects ([0042]). Ruggiero teaches that its composition may be formulated for “any convenient means for human delivery” such as in a vegetarian capsule, tablet, beverage, or packaged into a food item ([0058]).
Accordingly, although Duan teaches intragastric administration, it would have been obvious to modify this administration to instead be an oral administration based upon Ruggiero’s teaching that anti-aging formulations comprising Limosilactobacillus reuteri can be administered in forms “convenient…for human delivery” such as capsules, tablets, beverages, and foods ([0058]). There would have been a reasonable expectation of success because, as discussed above, it was previously known that Limosilactobacillus reuteri can be administered in anti-aging compositions through this route. This obviousness is based upon the “Some Teaching, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
For at least this reason, claim 24 is obvious over Duan in view of Ruggiero.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRANT C CURRENS whose telephone number is (571)272-0053. The examiner can normally be reached Monday - Thursday: 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GRANT C CURRENS/Examiner, Art Unit 1651
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