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 the Application
1. Claims 1-24 are pending and subject to examination on the merits. Claims 34-40 are withdrawn from consideration as being drawn to non-elected subject matter.
Priority
2. Acknowledgement is made of applicant’s claim for foreign priority based on an application filed in EP (EP19172858.3) on 06 May 2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 21 August 2025 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
Drawings
4. The drawings are objected to because none of the figures have x-axis labels. Corrected drawing sheets in compliance with 37 CFR 1.121d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
5. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (p. 26, line 3). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
6. Claims 10 and 20-24 objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple claims. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
Claim Rejections - 35 USC § 112(b)
7. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
8. Claims 4-5, 9, 14-15, and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
9. The term “increased” in claims 4-5 and 14-15 is a relative term which renders the claim indefinite. The term “increased” 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. The term increased should be followed by a baseline comparison, such as a mammal not administered the probiotic or a numerical value representative of said population.
10. The term “a mixture thereof” in claims 9 and 19 is a term which renders the claim indefinite. The term “a mixture thereof” 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. The claim should be amended to include language to make a mixture of bacterial species possible. The claim is interpreted as a probiotic of different strains of Lacticaseibacillus paracasei for examination purposes.
Claim Rejections - 35 USC § 101
11. 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.
12. Claims 1-9 and 11-19 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon) without additional elements that integrate the judicial exception into a practical application. An analysis with respect to the claims as a whole reveals that they do not include additional elements that integrate the judicial exception into a practical application. See MPEP 2106.
Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of the following steps:
Step (1) whether the claim is directed to one of the four categories recited in §101 (process, machine, manufacture or composition of matter);
Step (Revised 2A - Prong 1) do the claims recite an abstract idea (mathematical concepts, mental processes or method of organizing human activity), law of nature or natural phenomenon;
Step (Revised 2A - Prong 2) do the claims recite additional elements that integrate the judicial exception into a practical application; and
Step (2B) whether the claim as a whole recites something that amounts to significantly more than the judicial exception. (See 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG)).
Step 1: Yes; the claims are directed to a composition of matter.
Step 2A – Prong 1: Yes, the claims recite a natural phenomenon, namely, a naturally occurring bacterial strain, Lacticaseibacillus paracasei, and/or a composition thereof.
Step 2A – Prong 2: No, the claims do not recite any additional elements that integrate the judicial exception into a practical application because the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed with the Lacticaseibacillus paracasei. It is clear from the specification that nothing has been done to the L. paracasei that is being claimed other than isolating it in its natural form.
Step 2B: As noted in answering that of 2A – This judicial exception is not integrated into a practical application because Lacticaseibacillus paracasei are found in the (Abstract, Frolova et al., 2021, Life—cited herein). As such, there is no distinguishable modification to delineate this strain from any other naturally occurring strain.
Claim Rejections - 35 USC § 102
13. 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.
14. 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.
15. Claims 1-9 and 11-19 are rejected under 35 U.S.C. 102 as being anticipated by Wei et al. (Wei et al., 2019, Brain Research—cited herein).
Regarding claims 1-9, drawn to a Lacticaseibacillus paracasei, Wei et al. teaches Lacticaseibacillus paracasei administered by oral gavage in a mouse model of corticosterone-induced depression, where depression-like behaviors, symptoms of mental health, were tested and then serum and brain tissue were collected to assess the physiological responses to stress (abstract).. Regarding claims 11-19, drawn to a composition comprising Lacticaseibacillu paracasei, Wei et al. teaches a composition comprising Lacticaseibacillus paracasei, since the bacteria containing solution is administered by oral gavage (abstract).
It is noted; the intended use of the recited composition does not change the patentability of the composition itself. “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not impart novelty to the claimed product – In re Best 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). M.P.E.P. § 2112(I).
Conclusion
16. Claims 1-9 and 11-19 are rejected. Claims 10 and 20-24 are objected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIARA A MCKNIGHT whose telephone number is (703)756-4791. The examiner can normally be reached M-F 8:00am-4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached on (571) 272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CIARA A MCKNIGHT/Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656
