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 .
2. Applicants’ claim of 11/17/2023 is acknowledged.
Status of Claims
3. Claims 1-23 are pending.
Information Disclosure Statement
4. Applicants’ information disclosure statements of 12/16/2023 and 12/26/2024 are acknowledged. The references have been considered. Initialed copies are attached.
Drawings
5. The drawings submitted 11/17/2023 have been accepted by the examiner.
Claim Objection
6. Claims 13 and 14 are objected to because of the following informalities: Claim 13 and 14 are objected to recite the abbreviation of numerous proteins. For example, URAT1, GLUT9, OAT1 and ABCG2. Full name of said abbreviations are required, when it appears in the claim for the first time. Appropriate correction is required.
Claim Rejections - 35 USC § 112
7. 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
8. Claims 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) 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. This is a biological deposit rejection.
Claim 1-17 are rejected as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
The invention appears to employ novel strains of bacteria Lactobacillus paracasei LT12 and Lactobacillus plantarum CBT LP3 . It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit. Further it is unclear if the starting materials were readily available to the public at the time of invention.
The specification page 3 fails to recite full information about the deposit of said organism. It is not clear if the deposit was made and meet all the criteria set forth in 37 CFR 1.801-1.809. Because it is not clear that organism, having the accession number of Lactobacillus paracasei LT12 and Lactobacillus plantarum CBT LP3. are known and publicly available or can be reproducibly isolated from nature without undue experimentation. Without a publicly available deposit of the above strain, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the strains is an unpredictable event.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by the International Depository Authority under the provisions of the Budapest Treaty and that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application. These requirements are 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. Amendment of the specification to recite the date of the deposit and the complete name and full street address of the depository is required.
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:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) 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;
(c) the deposits will be maintained in the public repository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of 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
(d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the repository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of biological material not made under the Budapest Treaty must be filed in the application and must contain:
1) The name and address of the depository;
2) The name and address of the depositor;
3) The date of deposit;
4) The identity of the deposit and the accession number given by the depository;
5) The date of the viability test;
6) The procedures used to obtain a sample if test is not done by the depository; and
7) A statement that the deposit is capable of reproduction.
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.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the strains described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant’s possession at the time the application was filed.
Applicant’s attention is directed to In re Lundack, 773 F.2d.1216, 227 USPQ (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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
10. Claims 1, 4, 5, 6, 18, 19, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chang et al. (TW 201121553 A).
The claims are drawn to a method for reducing uric acid, protecting kidneys and immune modulation, comprising administering a composition comprising an effective amount of Lactobacillus paracasei LT12 to a subject in need thereof.
Chang et al. teach Lactobacillus paracasei LT12, which can serve as an immunomodulator (limitation of claim 1). Chang et al. teach a novel strain of Lactobacillus paracasei LT12 that has immunomodulatory functions, specifically its ability to stimulate the production of IFN-Ɣ, IL-lα, MCP-2, and TNF-α ( limitations of claims 5-6) see Examples 1-4. Chang et al. teach limitations of claims 18-20 which indicates that the composition of Lactobacillus paracasei LT12 can be used in food products (such as yogurt, cookies, cereals, chocolate, and snack bars), beverages (such as tea, non-alcoholic drinks, milk, and juice), or as a pharmaceutical formulation
containing a pharmaceutically acceptable carrier (see, Description of Invention). It also reveals the efficacy of this composition in regulating the immune system (such as innate immunity or adaptive immunity) or in treating allergies (see, Description of Invention). The prior art anticipates the above claims.
Claim Rejections - 35 USC § 102
11. Claims 1, 4, 5, 6, 18, 19, 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chang et al. (US 201101508383 A1).
Chang et al. US 201101508383 A1 teach Lactobacillus paracasei LT12, which can serve as an immunomodulator (see title, abstract and claims). Chang et al. teach a novel strain of Lactobacillus paracasei LT12 that has immunomodulatory functions, specifically its ability to stimulate the production of IFN-Ɣ, IL-lα, MCP-2, and TNF-α ( limitations of claims 5-6) see pages 14, 16,17, 18,21. Chang et al. teach limitations of claims 18-20 which indicates that the composition of Lactobacillus paracasei LT12 can be used in food products (such as yogurt, cookies, cereals, chocolate, and snack bars), beverages (such as tea, non-alcoholic drinks, milk, and juice), or as a pharmaceutical formulation containing a pharmaceutically acceptable carrier (see, pages 1,3,4,19). It also reveals the efficacy of this composition in regulating the immune system (such as innate immunity or adaptive immunity) or in treating allergies (see, Description of Invention). The prior art anticipates the above claims.
Claim Rejections - 35 USC § 102
12. Claim 16 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by KR 101611834.
Claim 16. A method for reducing uric acid, protecting kidneys and/or immune modulation comprising administering a composition comprising an effective amount of Lactobacillus plantarum CBT LP3 to a subject in need thereof.
KR 101611834 teach a method for treating metabolic disease and ameliorating colitis via modulating T-cells using compositions comprising Lactobacillus plantarum CBT LP3 ( see title and abstract). KR 101611834 recite “Another object of the present invention is to provide a pharmaceutical composition containing lactobacillus The present invention provides a pharmaceutical composition or food composition comprising Plantarum CBT LP3 strain.” KR 101611834 teach IL-6, TNF-a. ( see description). The prior art anticipates 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.
13. Claims 1, 15, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (TW 201121553 A) in view of KR 101611834.
Chang et al. TW 201121553 teach Lactobacillus paracasei LT12, which can serve as an immunomodulator (limitation of claim 1). Chang et al. teach a novel strain of Lactobacillus paracasei LT12 that has immunomodulatory functions, specifically its ability to stimulate the production of IFN-Ɣ, IL-lα, MCP-2, and TNF- see Examples 1-4. Chang et al. teach Lactobacillus paracasei LT12, which can serve as an immunomodulator (limitation of claim 1). Chang et al. teach a novel strain of Lactobacillus paracasei LT12 that has immunomodulatory functions, specifically its ability to stimulate the production of IFN-Ɣ, IL-lα, MCP-2, and TNF-α ( limitations of claims 5-6) see Examples 1-4. Chang et al. teach limitations of claims 18-20 which indicates that the composition of Lactobacillus paracasei LT12 can be used in food products (such as yogurt, cookies, cereals, chocolate, and snack bars), beverages (such as tea, non-alcoholic drinks, milk, and juice), or as a pharmaceutical formulation containing a pharmaceutically acceptable carrier (see, Description of Invention). It also reveals the efficacy of this composition in regulating the immune system (such as innate immunity or adaptive immunity) or in treating allergies (see, Description of Invention). Chang et al., teach the Lactobacillus paracasei LT12 and its combined use with Lactobacillus species strain. Chang et al. do not disclose the ability of Lactobacillus paracasei LT12 and its combined use with Lactobacillus plantarum CBT LP3 for immunomodulation.
However, KR 101611834 teach a method for treating metabolic disease and ameliorating colitis via modulating T-cells using compositions comprising Lactobacillus plantarum CBT LP3 ( see title and abstract). KR 101611834 recite “Another object of the present invention is to provide a pharmaceutical composition containing lactobacillus The present invention provides a pharmaceutical composition or food composition comprising Plantarum CBT LP3 strain” and at least one probiotic lactic acid bacteria.
It would have been obvious to one of ordinary skill in the art that to combine the teaching of above references to obtain claimed method. Because, Chang et al. teach Lactobacillus paracasei LT12 in combination with a second species, which can serve as an immunomodulator. Chang et al. teach a novel strain of Lactobacillus paracasei LT12 that has immunomodulatory functions, specifically its ability to stimulate the production of IFN-Ɣ, IL-lα, MCP-2, and TNF-α, see Examples 1-4. KR 101611834 teach a method for modulating T-cells using compositions comprising Lactobacillus plantarum CBT LP3 ( see title and abstract). The benefit of combining the above references is that all the refences teach lactic acid bacteria for treatment of disease, a skilled person trying to further use both strains of Chang et al. and KR 101611834 and would be motivated to target to treat more disease.
Claim Rejections - 35 USC § 103
14. Claims 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (TW 201121553 A) in view of Hsieh et al. (TW 202122101 A) and Wang et al. (CN 115414391 A). Art of record 1449.
The claims are drawn: Clam 1. A method for reducing uric acid, protecting kidneys and immune modulation, comprising administering a composition comprising an effective amount of Lactobacillus paracasei LT12 to a subject in need thereof.
Claim 15. The method of claim 1, wherein the composition further comprises Lactobacillus plantarum CBT LP3.
Claim 16. A method for reducing uric acid, protecting kidneys and/or immune modulation comprising administering a composition comprising an effective amount of Lactobacillus plantarum CBT LP3 to a subject in need thereof.
Chang et al., teach Lactobacillus paracasei LT12, which can serve as an immunomodulator (limitation of claim 1). Chang et al. teach a novel strain of Lactobacillus paracasei LT12 that has immunomodulatory functions, specifically its ability to stimulate the production of IFN-Ɣ, IL-lα, MCP-2, and TNF-α ( limitations of claims 5-6) see Examples 1-4. Chang et al. teach limitations of claims 18-20 which indicates that the composition of Lactobacillus paracasei LT12 can be used in food products (such as yogurt, cookies, cereals, chocolate, and snack bars), beverages (such as tea, non-alcoholic drinks, milk, and juice), or as a pharmaceutical formulation containing a pharmaceutically acceptable carrier (see, Description of Invention). It also reveals the efficacy of this composition in regulating the immune system (such as innate immunity or adaptive immunity) or in treating allergies (see, Description of Invention).
Chang et al. do not disclose the ability of Lactobacillus paracasei LT12 and its combined use with Lactobacillus plantarum CBT LP3.
However, Hsieh et al. TW 202122101 A teach novel lactic acid bacteria and their use in the treatment and/or prevention of hyperuricemia and alcoholic liver injury, revealing a pharmaceutical composition for treating and/or preventing hyperuricemia that includes Lactobacillus paracasei TTL 6-10 and Lactobacillus plantarum TTL 8-16 (see Claims 1-4). Hsieh et al. teach that the TTL 6--10 and TTL 8--16 strains have high degradation rates for inosine and guanosine, with degradation rates of 99% and over 98%, respectively (see Example 5). It also reveals that the TTL 6-10 strain reduces uric acid and urea nitrogen levels by 20% and 27.27%, respectively, while the TTL 8--16 strain reduces uric acid and urea nitrogen levels by 16.43% and 22.42%, respectively (see, Example 7).
Wang et al. teach limitations of claims 21-23 treatment of variety chronic kidney disease by preparations of food or medicine using Lactobacillus plantarum MA2 ( see description). Wang et al. teach limitations of claims 21-23 removing uremia toxins such as creatinine, urea and uric acid ( see detailed description).
It would have been obvious to one of ordinary skill in the art that to combine the teaching of above references to obtain claimed method. Because, Chang et al. teach Lactobacillus paracasei LT12, which can serve as an immunomodulator (limitation of claim 1). Chang et al. teach a novel strain of Lactobacillus paracasei LT12 that has immunomodulatory functions, specifically its ability to stimulate the production of IFN-Ɣ, IL-lα, MCP-2, and TNF-α ( limitations of claims 5-6) see Examples 1-4. The benefit of combining the above references is that all the refences teach lactic acid bacteria for treatment of disease, a skilled person trying to further use the strain of Chang et al.. would be motivated to target to treat more disease.
Although neither Chang et al. and Hsieh et al. explicitly discloses the Lactobacillus plantarum CBT LP3 mentioned in the instant invention or its efficacy, Hsieh et al. has already demonstrated the use of Lactobacillus paracasei and/or Lactobacillus plantarum in the treatment or prevention of hyperuricemia caused by high purine intake and its efficacy in preventing kidney disease. Given that the description, claims, and necessary diagrams of the current application do not allow for distinguishing the claimed invention from the cited references in terms of unexpected efficacy, and since both Chang et al. and Hsieh et al. pertain to the technical field of lactic acid bacteria applications aimed at addressing disease treatment, it is reasonable to conclude that a person skilled in the art would have the motivation to simply incorporate Lactobacillus paracasei LT12 disclosed in Chang et al. with Lactobacillus paracasei TTL 6-10 from Hsieh et al, , and to select a Lactobacillus plantarum strain with good inosine and guanosine degradation rates to prepare a composition with Lactobacillus paracasei LT12, subsequently testing its ability to treat and/or prevent hyperuricemia. Therefore, the combination of references makes the invention obvious.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination 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, "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to combine different genes in a genetically modify organism, which function in a predictable manner to yield a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
15. No claims are allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHATOL S SHAHNAN SHAH whose telephone number is (571)272-0863. The examiner can normally be reached on Mon-Tue, Thurs-Fri 12pm-8pm.
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/KHATOL S SHAHNAN SHAH/Examiner, Art Unit 1645 February 21, 2026
/JANA A HINES/Primary Examiner, Art Unit 1645