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 Claims
2. Claims 1-4 are pending in this application.
Drawings
3. The drawings in this application filed 10/31/2023 are accepted by the examiner.
Information Disclosure Statement
4. The information disclosure statement filed 10/31/2023 has been considered. Initialed copy is enclosed.
Priority
5. The instant application is a continuation of PCT/CN2023/077307 filed on 02/21/2023, which claims foreign priority under 35 U.S.C. 119(a)-(d) based on application CN202210306390 .X filed in China on 03/25/2022. Certified copy of the foreign priority document is on file.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 1-4 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claims contain 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.
It is apparent that Lactobacillus fermentum CQPC04 with preservation number CGMCC No: 14493 is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the Lactobacillus fermentum CQPC04 with preservation number CGMCC No: 14493. The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. Therefore, a deposit at a recognized depository may be made to obviate this rejection.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
Applicant can obviate this rejection by satisfying the requirements of (a)-(d) above.
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. 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.
10. Claims 1-4 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.
Claims 1-4 recite an application of the Lactobacillus fermentum CQPC04 with preservation number CGMCC No: 14493 in preparation of a product for treating of inflammation related thrombosis. It cannot be determined if said claims are directed to: (i) a method of preparing a medication comprising the Lactobacillus fermentum CQPC04; or (ii) a method of using said Lactobacillus fermentum CQPC04 to relieve thrombosis. In the interest of compact prosecution, the first interpretation is taken.
Furthermore, claims are indefinite because it does not set forth any steps that specify how the method is performed (i.e., how the medication is prepared). Without any active step, a person with ordinary skill in the art would not know what steps to execute in order to make the medication. The claims either attempt to claim a process without setting forth any steps involved in the process or characterize the strain as having the capability of the recited process. The claims are drawn to a product by process. Therefore, claims 1-4 are indefinite. See MPEP 2173.05(q).
Claims 2-4 are rejected because the claims are not further limiting.
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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring organism without significantly more.
The Supreme Court has required analysis based on a 3-part test for subject
matter eligibility.
- Step 1: Is the claim to a process, machine, manufacture, or composition of
matter?
- Step 2A (The Judicial Exceptions): Prong 1: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
-Step 2A (The Judicial Exceptions): Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
- Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
Claims 1 -4 recite a Lactobacillus fermentum CQPC04 with preservation number CGMCC No: 14493 and a microbial preparation of the strain that is used in preparation of a product for treating thrombosis, which is a statutory category of invention (Step 1: Yes).
Claims 1 -4 are drawn to the Lactobacillus fermentum CQPC04 as a product and in preparation of a product for treating thrombosis and inflammatory related thrombosis. As evidenced by the Specification, the Lactobacillus fermentum CQPC04 strain was isolated from natural fermented pickle source ( see page5). There is no evidence that this particular Lactobacillus fermentum CQPC04 strain has any markedly different characteristic from other Lactobacillus fermentum CQPC04 strains, nor that it has been genetically modified or altered that would enhance functionality in the ability for treating thrombosis. Therefore, the Lactobacillus fermentum CQPC04 strain is a naturally occurring organism that is a judicial exception in the form of being a product of nature (Step 2A, Prong 1: Yes).
Claims 2 recites an application of Lactobacillus fermentum CQPC04 in preparation of a product for treating thrombosis by regulating microbial composition increasing beneficial bacteria.
Claims 3 recites an application of Lactobacillus fermentum CQPC04 in preparation of a product for treating thrombosis wherein, Lactobacillus fermentum CQPC04 improve coagulation abnormality.
Claims 4 recites an application of Lactobacillus fermentum CQPC04 in preparation of a product for treating thrombosis wherein, Lactobacillus fermentum CQPC04 reduces oxidative damage.
Furthermore, the claims do not recite a particular prophylaxis or treatment for inflammatory colon cancer, merely an intended use of the claimed invention, thus the claims do not recite additional elements that integrate the judicial exception into a practical application (Step 2A, Prong 2: No).
Claims 1 -4 do not recite additional elements that amount to significantly more than the judicial exception (Step 2B: No).
Therefore, claims 1 -4 are not patent eligible subject matter.
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.
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.
(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.
14. Claims 1-4 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Zhao et al. (Pub. No. CN 109481476 (B)).
The claims are drawn to:
Claim 1. An application of a Lactobacillus fermentum CQPC04 with a preservation number of CGMCC NO.14493 in preparing products for treating thrombus, wherein the thrombus is inflammation-related thrombus.
Claim 2. The application of the Lactobacillus fermentum CQPC04 in preparing products for treating thrombus according to claim 1, wherein the Lactobacillus fermentum CQPC04 exerts an inhibitory effect on thrombosis by regulating intestinal microbial composition, increasing beneficial bacteria and maintaining intestinal health.
Claim 3. The application of the Lactobacillus fermentum CQPC04 in preparing products for treating thrombus according to claim 1, wherein the Lactobacillus fermentum CQPC04 improves coagulation abnormality caused by thrombus.
Claim 4. The application of the Lactobacillus fermentum CQPC04 in preparing products for treating thrombus according to claim 1, wherein the Lactobacillus fermentum CQPC04 reduces oxidative
Zhao et al. CN 109481476 (B) recite:
Claim1. Application of Lactobacillus fermentum CQPC04 with the deposit number of CGMCC NO.14493 in the preparation of food or medicine for improving ulcerative colitis.
Claim 2. The application of Lactobacillus fermentum CQPC04 as claimed in claim 1 in the preparation of food or medicine for improving ulcerative colitis, wherein the food is a fermented food.
Claim 3. The application of Lactobacillus fermentum CQPC04 as claimed in claim 2 in preparing the food or medicine that improves ulcerative colitis, it is characterized in that, described fermented food is lactic acid bacteria milk drink, fermented milk, milk powder or milk powder capsule
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicant’s strain differs, and if so to what extent, from the strain disclosed by a prior art. In this case, it can be established that Zhao et al. Lactobacillus fermentum CQPC04 with the deposit number of CGMCC NO.14493, which has the same taxonomic classification and shares the property of being able to treat gastrointestinal disease and reduce oxidative damage, demonstrates a reasonable probability that it is identical to the recited strain. Thus, the burden of establishing novelty by objective evidence is shifted to applicant.
Merely because a characteristic of a claimed strain is not disclosed in a reference does not make it patentable. The claimed strain may possess inherent characteristics that cannot be revealed by the tests performed in the prior art. However, the disclosed bacterial strain may be the same bacterial strain as claimed. Clear evidence that the disclosed strain does not possess a critical characteristic that is possessed by the claimed strain, would advance prosecution.
Limitations such as reduce thrombosis, maintain intestinal health and improve coagulation, these phrases merely state intended uses and are not considered actual limitations.
Regardless, It is noted that the products being prepared by Zhao et al. are “medicine for improving ulcerative colitis,” (claim 1) and “medicine for improving ulcerative colitis,” (claim 2), wherein Zhao et al. recite “Lactobacillus fermentum CQPC04 can protect the integrality of mucous membrane of colon well above, reduce inflammation of damage of colon” ( see section 5, mouse studies), additionally, Zhao et al recite Lactobacillus fermentum CQPC04 reduce oxygen radical oxidative damage caused by colitis mice”.
Hence, claims 1-4 are anticipated by Zhao et al. CN 109481476 (B).
15. Claims 1-4 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Zhao et al. (Pub. No. CN 109628346 A). Art of record 1449.
The claims are drawn to:
Claim 1. An application of a Lactobacillus fermentum CQPC04 with a preservation number of CGMCC NO.14493 in preparing products for treating thrombus, wherein the thrombus is inflammation-related thrombus.
Claim 2. The application of the Lactobacillus fermentum CQPC04 in preparing products for treating thrombus according to claim 1, wherein the Lactobacillus fermentum CQPC04 exerts an inhibitory effect on thrombosis by regulating intestinal microbial composition, increasing beneficial bacteria and maintaining intestinal health.
Claim 3. The application of the Lactobacillus fermentum CQPC04 in preparing products for treating thrombus according to claim 1, wherein the Lactobacillus fermentum CQPC04 improves coagulation abnormality caused by thrombus.
Claim 4. The application of the Lactobacillus fermentum CQPC04 in preparing products for treating thrombus according to claim 1, wherein the Lactobacillus fermentum CQPC04 reduces oxidative
Zhao et al. CN 109628346 A recite:
Claim 1. Lactobacillus fermentum CQPC04, deposit number is CGMCC NO.14493.
Claim 2. Application of the lactobacillus fermentum CQPC04 described in claim 1 in the food that preparation improves constipation.
Claim 3. Application of the lactobacillus fermentum CQPC04 as claimed in claim 2 in the food that preparation improves constipation, feature exist In the food is fermented food.
Claim 4. Application of the lactobacillus fermentum CQPC04 as claimed in claim 3 in the food that preparation improves constipation, feature exist In the fermented food is lactic acid bacteria milk beverage, acidified milk, milk powder or milk powder capsule.
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicant’s strain differs, and if so to what extent, from the strain disclosed by a prior art. In this case, it can be established that Zhao et al. Lactobacillus fermentum CQPC04 with the deposit number of CGMCC NO.14493, which has the same taxonomic classification and shares the property of being able to treat constipation, demonstrates a reasonable probability that it is identical to the recited strain. Thus, the burden of establishing novelty by objective evidence is shifted to applicant.
Merely because a characteristic of a claimed strain is not disclosed in a reference does not make it patentable. The claimed strain may possess inherent characteristics that cannot be revealed by the tests performed in the prior art. However, the disclosed bacterial strain may be the same bacterial strain as claimed. Clear evidence that the disclosed strain does not possess a critical characteristic that is possessed by the claimed strain, would advance prosecution.
Limitations such as reduce thrombosis, maintain intestinal health and improve coagulation, these phrases merely state intended uses and are not considered actual limitations.
Regardless, It is noted that the products being prepared by Zhao et al. are “improves constipation,” (claim 1) and (claim 2), wherein Zhao et al. recite “Lactobacillus fermentum CQPC04 can reduce constipation.
Hence, claims 1-4 are anticipated by Zhao et al. CN 109628346 A.
Claim Rejections - 35 USC § 103
16. 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.
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.
17. Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. CN 109628346 A in view of Yi et al. Frontiers in Microbiology , vol. 11, September 3, 2020. Art of record 1449.
The claims are drawn to:
Claim 1. An application of a Lactobacillus fermentum CQPC04 with a preservation number of CGMCC NO.14493 in preparing products for treating thrombus, wherein the thrombus is inflammation-related thrombus.
Claim 2. The application of the Lactobacillus fermentum CQPC04 in preparing products for treating thrombus according to claim 1, wherein the Lactobacillus fermentum CQPC04 exerts an inhibitory effect on thrombosis by regulating intestinal microbial composition, increasing beneficial bacteria and maintaining intestinal health.
Claim 3. The application of the Lactobacillus fermentum CQPC04 in preparing products for treating thrombus according to claim 1, wherein the Lactobacillus fermentum CQPC04 improves coagulation abnormality caused by thrombus.
Claim 4. The application of the Lactobacillus fermentum CQPC04 in preparing products for treating thrombus according to claim 1, wherein the Lactobacillus fermentum CQPC04 reduces oxidative
Zhao et al. CN 109628346 A recite:
Claim 1. Lactobacillus fermentum CQPC04, deposit number is CGMCC NO.14493.
Claim 2. Application of the lactobacillus fermentum CQPC04 described in claim 1 in the food that preparation improves constipation.
Claim 3. Application of the lactobacillus fermentum CQPC04 as claimed in claim 2 in the food that preparation improves constipation, feature exist In the food is fermented food.
Claim 4. Application of the lactobacillus fermentum CQPC04 as claimed in claim 3 in the food that preparation improves constipation, feature exist In the fermented food is lactic acid bacteria milk beverage, acidified milk, milk powder or milk powder capsule.
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicant’s strain differs, and if so to what extent, from the strain disclosed by a prior art. In this case, it can be established that Zhao et al. Lactobacillus fermentum CQPC04 with the deposit number of CGMCC NO.14493, which has the same taxonomic classification and shares the property of being able to treat constipation, demonstrates a reasonable probability that it is identical to the recited strain. Thus, the burden of establishing novelty by objective evidence is shifted to applicant.
Merely because a characteristic of a claimed strain is not disclosed in a reference does not make it patentable. The claimed strain may possess inherent characteristics that cannot be revealed by the tests performed in the prior art. However, the disclosed bacterial strain may be the same bacterial strain as claimed. Clear evidence that the disclosed strain does not possess a critical characteristic that is possessed by the claimed strain, would advance prosecution.
Limitations such as reduce thrombosis, maintain intestinal health and improve coagulation, these phrases merely state intended uses and are not considered actual limitations.
Regardless, It is noted that the products being prepared by Zhao et al. are “improves constipation,” (claim 1) and (claim 2), wherein Zhao et al. recite “Lactobacillus fermentum CQPC04 can reduce constipation. Zhao et al. do not teach reduction of oxidative damage and inflammatory response.
Yi et al. teach that commercial stain of Lactobacillus fermentum CQPC04 can regulate lipid levels and protect the body by restoring liver function Lactobacillus fermentum CQPC04 can also reduce inflammation and oxidative stress, as well as regulate the PPAR-a signaling pathways. Lactobacillus fermentum CQPC04 also can reduce colitis caused by a high-fat diet and regulate intestinal flora. Lactobacillus fermentum CQPC04 is a high-quality microbial resource with significant probiotic value.
Therefore, it would have been prima facie obvious at the time of applicants’ invention combine the teachings of the above references in order to provide the claimed method. One of ordinary skill in the art would have a reasonable expectation of success by teaching of Zhao et al. who teach Lactobacillus fermentum CQPC04, deposit number is CGMCC NO.14493 and Yi et al., who teach that Lactobacillus fermentum CQPC04 reduce inflammation and oxidative damage to combine these references to obtain the instant invention. Because the teachings of both references are drawn to Lactobacillus fermentum CQPC04.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known compositions 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 that "The combination of familiar element according to known compositions is likely to be obvious when it does no more than yield predictable results". It is well known to combine methos to provide a better method 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
18. No claims are allowed.
19. 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 Mon-Tue, Thurs-Fri 12pm-8pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E. Kolker can be reached at (571) 272 -3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KHATOL SHAHNAN -SHAH/
Examiner, Art Unit 1645
January 5, 2026
/JANA A HINES/Primary Examiner, Art Unit 1645