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 .
DETAILED ACTION
Applicant’s preliminary amendment filed on 06 June 2024 is entered. Claim 1 is amended, claims 2-10 are cancelled, and claims 11-29 are new.
Claims 1 and 11-29 are pending and under examination.
Priority
Acknowledgment is made of Applicant’s claim for priority to the filing date of CN202111457132.3 filed 02 December 2021 and PCT/CN2022/135105 filed 29 November 2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, the certified copy is in Mandarin. Applicant’s claim to the foreign priority filing date of CN202111457132.3 filed 02 December 2021 can be perfected by filing an English translation of the certified copy.
Therefore, the effective filing date is 29 November 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10 December 2024, 24 March 2025, and 22 April 2025 are being considered by the examiner.
Claim Objections
Claims 1, 12, 14, 17, 22-23, 25-26, and 28-29 are objected to because of the following informalities:
Claim 1 recites convoluted, redundant, and extraneous language. It is suggested to amend the claim to “A high-protein Saccharomyces cerevisiae strain AMCC 30743 deposited in the China Center for Type Culture Collection (CCTCC) under the accession number CCTCC No. M 2021941.”
Claim 12 step (1) recites “performing amplified culture”. The phrase “amplified culture” is a noun describing a particular culture, not a verb, thus an amplified culture cannot be “performed”. Similarly, claim 12 also recites “performing fermented culture”. The phrase “fermented culture” is a noun describing a particular culture, not a verb, thus a fermented culture cannot be “performed”.
Claim 14 recites “the high-protein Saccharomyces cerevisiae strain is used as feeds, food and health care products.” The words “feeds” and “products” should be corrected to their singular forms because the strain is singular, not plural. Additionally, an “a” should be added before the “feed”, “food”, and “health care product”. Claims 25 and 28 have the same issues.
Claim 17 is missing the word “is” before the word “obtained”, and the word “and” is missing after the phrase “15-20h.”
Claim 18 is missing the word “the” after a dry weight of and before yeast cells.
Claims 22-23 recite “a measured succinic acid content in a supernatant which were obtained…”. The word “were” should be changed to “is”.
Claim 26 recites “the microbial agent is used as condiments”. The word condiments should be corrected to its singular form because the microbial agent is singular, not plural. Additionally, an “a” should be added before the word “condiment”. Claim 29 has the same issues.
Appropriate correction is required.
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 and 11-29 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 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.
It is apparent that biological material Saccharomyces cerevisiae AMCC 30743 preservation number CCTCC M 2021941 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 biological material Saccharomyces cerevisiae AMCC 30743 preservation number CCTCC M 2021941.
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 Saccharomyces cerevisiae AMCC 30743 preservation number CCTCC M 2021941 that is considered necessary to make and use the invention is both known and readily available to the public.
It is noted that Applicants have deposited Saccharomyces cerevisiae AMCC 30743 at China Center for Type Culture Collection under preservation number CCTCC M 2021941, but there is no indication or statement in the specification as to 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 all restrictions imposed by the depositor on the availability to the public on the deposited material will be irrevocably removed upon granting of the 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).
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 and 11-29 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.
Claim 1 recites a high-protein Saccharomyces cerevisiae AMCC 30743 strain preservation number CCTCC No. M 2021941. It is unclear what the metes and bounds of the “high-protein” limitation are. There is no special definition in the disclosure which clarifies what constitutes a “high-protein” strain, nor any indication as to what levels of protein are considered “high”, nor any indication of what reference should be used to determine if a protein level is high.
Claim 1 recites limitations within parentheses. It is unclear whether the contents of the parenthetical phrases are part of the claim limitations and intended to be limiting, or if the contents of the parenthetical phrases are merely exemplary and thus not required. It also appears that the limitations within the parentheses are redundant. If this is the case, the entirety of the parenthetical phrases may be deleted to obviate this rejection.
Claim 12 recites that the method of claim 11 further comprises: (1) performing an amplified culture to obtain a product, and (2) fermenting the product. The numbering of these two additional steps implies that they are the first and second steps in the claimed method; however, claim 11 already recites a step of culturing the high-protein Saccharomyces cerevisiae strain. It is unclear what the meaning of the term “amplified culture” is, nor what actions must be taken to perform an “amplified culture” such that a product may be obtained. There is no indication in the disclosure as to how an amplified culture is different from a regular yeast cell culture obtained after the step of culturing in claim 11, from which claim 12 depends. It is further unclear if the two additional steps of claim 12 are performed after the culturing step in claim 11, or if steps (1) and (2) of claim 12 are performed before the culturing step of claim 11.
Claims 18-20 recite the limitations, a dry weight of yeast cells, and the dry weight of the yeast cells, in line 2. There is insufficient antecedent basis for the limitation in the claims.
Claims 22-23 recite the limitation “the yeast milk” in lines 3-4. There is insufficient antecedent basis for this limitation in the claims.
Claims 11-29 are dependent on claim 1, and claims 17-26 are dependent on claim 16, so those dependent claims are indefinite for the same reasons.
Claim Rejections - 35 USC § 101
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.
Claims 1 and 13-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a product of nature without significantly more.
Claims 1 and 13-29 are drawn to the statutory category of compositions of matter (Step 1: Yes).
Claims 1 and 13-15 recite a high-protein Saccharomyces cerevisiae AMCC 30743 strain preservation number CCTCC No. M 2021941. The claimed Saccharomyces cerevisiae AMCC 30743 strain is a naturally occurring strain isolated from yogurt, as evidenced by Example 1 (pg. 7) of the specification.
Claims 16-26 recite a microbial agent obtained from the high-protein Saccharomyces cerevisiae AMCC 30743 strain preservation number CCTCC No. M 2021941. The disclosure does not provide a special definition for a microbial agent. The BRI of the claimed microbial agent encompasses the natural yeast cells themselves or compounds produced by or found in the natural yeast cells, including DNA, RNA, proteins, amino acids, and even water.
Claim 18 recites that the microbial agent comprises intracellular proteins. Claims 19-20 recite that the microbial agent comprises RNA. Claim 21 recites that the microbial agent has intracellular glutamic acid. Proteins, RNA, and glutamic acid (an amnio acid used in proteins) are naturally occurring biochemical compounds.
Claims 27-29 recite a yeast extract of the high-protein Saccharomyces cerevisiae AMCC 30743 strain preservation number CCTCC No. M 2021941. The disclosure does not provide a special definition for yeast extract. The BRI of the claimed yeast extract encompasses compounds produced by or found in the natural yeast cells themselves, including DNA, RNA, proteins, amino acids, and even water.
The claims are all drawn to naturally occurring organisms and/or naturally occurring compounds produced by or found in those natural yeast cells. Therefore the instant invention recites a judicial exception of a product of nature (Step 2A Prong One: Yes).
This judicial exception is not integrated into a practical application, nor do the claims include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are all direct to compositions of matter, and no active steps are recited which limit the products of nature to being used for a practical application, such as in disease treatment or food enrichment.
Claims 13-15 recite intended uses of the claimed high-protein Saccharomyces cerevisiae AMCC 30743 strain preservation number CCTCC No. M 2021941, claims 24-26 recite intended uses of the claimed microbial agent, and claims 28-29 recite intended uses of the yeast extract. However, none of these intended uses recite method steps which limit the invention to being used for a practical purpose.
Claims 17, 22-23, and 27 recite product-by-process language which describe how the claimed products are produced. MPEP §2113(I) states that product-by-process claims are not limited by the manipulations of the process, only by the implied structure of the steps. As such, the claims are not limited by the steps used to produce the natural products recited therein.
Therefore, the instant invention is directed to the judicial exception of a product of nature (Step 2A Prong Two: No), and does not include any additional elements that amount to significantly more than the recited judicial exception of a product of nature, so the instant invention is not patent eligible subject matter under 35 USC §101 (Step 2B: No).
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 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 11-12 and 16-29 are rejected under 35 U.S.C. 103 as being unpatentable over Jing et al. (CN 108835363 A, published 20 November 2018).
Claims 17, 22-23, and 27 recite product-by-process language which describe how the claimed products are produced. MPEP §2113(I) states that product-by-process claims are not limited by the manipulations of the process, only by the implied structure of the steps. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
The BRI of claim 13 limitation “(1) performing amplified culture” includes simply culturing the Saccharomyces cerevisiae because there is no indication in the disclosure that an “amplified culture” is any different from a simple yeast cell culture.
The BRI of a microbial agent, in claims 16-26, encompasses the Saccharomyces cerevisiae AMCC 30743 strain preservation number CCTCC No. M 2021941 yeast cells themselves or compounds produced by or found in the yeast cells, including DNA, RNA, proteins, amino acids, and even water.
The BRI of a yeast extract, in claims 27-29, encompasses compounds produced by or found in the Saccharomyces cerevisiae AMCC 30743 strain preservation number CCTCC No. M 2021941 yeast cells themselves, including DNA, RNA, proteins, amino acids, and even water.
Regarding claims 11-12, Jing teaches a method of preparing a high-protein fermented feed comprising inoculating a liquid culture medium with Saccharomyces cerevisiae and culturing to obtain a seed solution, which is then inoculated into a fermentation substrate and fermented at 27-32°C (Jing abstract).
Jing does not teach that the Saccharomyces cerevisiae used in their culturing method is Saccharomyces cerevisiae AMCC 30743 strain preservation number CCTCC No. M 2021941.
However, the steps in Jing’s method are performed using the same yeast species, Saccharomyces cerevisiae, and Jing also teaches that the resultant feed is high in protein content. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to perform Jing’s culture method using any strain of Saccharomyces cerevisiae. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because doing so would grow the Saccharomyces cerevisiae to a higher concentration and provide a high-protein content composition comprising the Saccharomyces cerevisiae, as taught by Jing. One of ordinary skill in the art would predictably expect the culture method of Jing to work regardless of the specific strain of Saccharomyces cerevisiae yeast.
Regarding claims 16-29, the resultant fermented feed produced by Jing is commensurate in scope with the BRI of the microbial agent and yeast extract as claimed in claims 16-29 as discussed in the BRI section above because Jing’s fermented feed contains the Saccharomyces cerevisiae cells and any compounds produced or isolated therefrom.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER M DURYEE whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached on (571)-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Alexander M Duryee/Examiner, Art Unit 1657 /LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
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