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 .
Response to Election/Restrictions and Status of Claims
Applicant’s election of Group I, Claims 1-7, without traverse in the reply filed on 03/03/2026 is acknowledged by the Examiner. Claim 8 is withdrawn pursuant to 37 C.F.R. 1.142(b) as being drawn to non-elected subject matter. The claims corresponding to the elected subject matter are Claims 1-7, and are herein acted on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/12/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is considered by the examiner.
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.
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.
Claims 1-7 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.
The claims are drawn to a method of use of Rhodosporidium toruloides DL-XSY01 or its fermentation broth in the preparation of a product capable of degrading ethyl carbamate,. Rhodosporidium toruloides DL-XSY01 must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public as they are essential to the claimed invention. If the microbial agent, herein Rhodosporidium toruloides DL-XSY01, is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a repeatable process to obtain the exact same microbial agents in each occurrence, and it is not apparent if such microbial agents are readily available to the public as the Examiner was unable to find the deposits listed in the ATCC database. Deposit of the microbial agents with an acceptable depository is required.
Additionally, if a deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating 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 a deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing 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;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
For each deposit made pursuant to these regulations, the specification shall be amended to contain (see 37 CFR 1.809):
(1) The accession number for the deposit;
(2) The date of the deposit;
(3) A description of the deposited biological material sufficient to specifically identify it and to permit examination; and
(4) The name and address of the depository.
Applicant stated in the instant specification that a strain of R. toruloides DL-XSY01, classified as R. toruloides, has been deposited in the China General Microbiological Culture Collection Center (CGMCC) on October 8, 2021, with a preservation number being CGMCC No. 23534, and the preservation address is Institute of Microbiology, Chinese Academy of Sciences, No.3, Yard No.1, Beichen West Road, Chaoyang District, Beijing [0053]. Applicant provided a report from CGMCCC acknowledging receipt of the biological deposit. However, the Examiner was also unable to find the deposit in the China General Microbiological Culture Collection Center website. It is not clear whether the deposit was made and accepted by the depository under the terms of the Budapest treaty. Furthermore, there is no indication of public availability. 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). If the deposit(s) was/were made after the effective filing date of the application for a patent in the United States, a verified statement is required from a person in a position to corroborate that R. toruloides DL-XSY01, described in the specification as filed are the same as that deposited in the depository. Corroboration may take the form of a showing of 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.
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.
Claims 1-7 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 pre-AIA the applicant regards as the invention.
Claims 1 is drawn to a method of use comprising adding R. toruloides during the preparation of a product. However, it is unclear as to what R. toruloides is being added to. Therefore, the step is deemed incomplete, and the is indefinite and rejected. Clarification is required.
All claims depending from Claim 1 are also rejected.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Yan et al. (CN 102492633 A, cited in the IDS, machine translation from IP.com), hereinafter Yan, and in view of Sumino et al. (US 5,000,966, cited in IDS), hereinafter Sumino.
Regarding Claim 1, Yan relates the invention of applying Rhodotorula mucilaginosa in liquor products and food for the degradation of ethylcarbamate/urethane (EC) (Abstract). Yan provides a yeast strain of Rhodotorula mucilaginosa with the preservation number of 5081, and can be used for brewing the wine, liquor, and other food (Abstract).
Yan does not teach Rhodosporidium toruloides DL-XSY01.
Sumino is in the same field and also recognizes that EC in an alcoholic liquor is decomposed by contacting the alcoholic liquor with a culture broth or processed matter thereof obtained from a Gluconobacter, Flavobacterium, Arthrobacter, Achronobacter, Alcaligenes, Pseudomonas, Klebsiella, Rhodotorula, Rhodosporidium, Trichosporon or Candida to give an alcoholic liquor with improved quality, and low ethyl carbamate content (Abstract). Sumino gives specific examples of strains producing enzymes capable of decomposing ethyl carbamate including Rhodosporidium toruloides IFO 10032 (Col. 2, lines 14-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Sumino with that of Yan, and substitute the Rhodotorula mucilaginosa on Yan with any of the 20 strains producing enzymes capable of decomposing ethyl carbamate, and therefore also use Rhodosporidium toruloides IFO 10032. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. See MPEP 2143.
One would then look further into the different databases of yeast, and perform mutation experiments guided by the deposited and known sequences, in order to optimize the ability to decompose ethyl carbamate, and arrive at different mutations. Therefore, the claimed invention of the instant application would have been obvious to one skilled in the art at the time of the invention. The ordinary artisan would have been motivated to simply substitute one known element for another to obtain predictable results. The known work and sequences, specifically R. toruloides DL-XSY01 which applicant claims to be available to the public beginning October 8, 2021, would serve as one of the variations which would be predictable to one of ordinary skill in the art. The Examine has shown how one skilled in the art would use Blastn from NCBI to design different mutations and find R. toruloides DL-XSY01, if it is publicly available. See search documents.
Regarding Claim 2, Sumino studies the activities of different culture broths including R. toruloides IFO 10032, grown in agar media, on decomposing ethyl carbamate (Examples 1 and 2).
Claims 3-4 is rejected under 35 U.S.C. 103 as being unpatentable over Yan in view of Sumino, as applied to Claims 1-2, in further view of Fang et al. (US 10,253,285 B2), hereinafter Fang.
Yan does not teach the amount of microorganism to use for degrading the ethyl carbamate.
Fang also teaches the degradation of ethyl carbamate in food, specifically Chinese liquor, using microorganism, Bacillus amyloliquefaciens JP21 (Abstract; Example 4). Fang teaches inoculating the grains with 1~9 x107 cfu/g for liquor fermentation (Col. 6, lines 4-8; Claim 7). The Examiner interprets 1~9 x107 cfu/g to be the same as 1~9 x107 cfu/mL, which is close to the claimed 3x108 cfu/mL.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to add Fang to Yan and Sumino, and use the amount of microorganism taught by Fang as starting amount for inoculating the R. toruloides taught by Sumino to apply in the EC-degradation method taught by Yan. One would optimize the amount as needed. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05.
Regarding Claim 4, Sumino has taught the activity of R. toruloides IFO 10032 on decomposing ethyl carbamate (Examples 1 and 2).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Yan in view of Sumino, as applied to Claim 1, in further view of Feng et al. (CN 111621428 A, machine translation from IP.com), hereinafter Feng.
Regarding Claims 5-7, Yan and Sumino do not teach the sterilization after addition of R. toruloides. Sumino, however, teaches application to foodstuffs including alcoholic liquors, all brewed beverages such as refined sake, beer, wine, samshu or the like, and spirits such as whisky, brandy, shochu or the like (Col. 1, lines 5-10).
Feng is in the same field and also teaches Rhodotorula mucilaginosa for fermenting high-salt dilute soy sauce, and the flavor and the quality of soy sauce products are improved (Abstract; Claim 3). Feng teaches sterile conditions (Claim 3). The method of Feng includes a step of uniformly mixing the finished koji with saline water to obtain sauce mash, performing primary natural fermentation treatment on the sauce mash, then adding the salt-tolerant Rhodotorula mucilaginosa bacterial liquid, performing secondary natural fermentation treatment, sterilizing, filtering and taking filtrate to obtain the soy sauce. As such, a sterilization step is performed after adding the microorganism to obtain a sterile soy sauce.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Feng with Yan and Sumino, and sterilize after adding the microorganism to obtain a sterile food.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached on M-F, 10-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached on (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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