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 amendment filed on 13 July 2026 is entered. Claim 12 is amended, claims 1-11 and 13-29 are cancelled, and claims 31-45 are new. Claims 12 and 30-45 are pending and under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 13 July 2026 is being considered by the examiner.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12 recites is convoluted. The preamble should be changed to “a method of fermenting Saccharomyces cerevisiae”.
Claim 12 recites “a YPD liquid culture medium”. The abbreviation YPD should be spelled out as “Yeast extract Peptone Dextrose”.
Claim 12 recites the limitation “the Saccharomyces cerevisiae AMCC 30743 strain being preserved in the China Center for Type Culture Collection (CCTCC), and having a preservation number of CCTCC NO: M 2021941”. Since the limitation is not a method step, it should be moved to the end of the claim as a wherein clause, such that it recites: “wherein the Saccharomyces cerevisiae AMCC 30743 strain being preserved in the China Center for Type Culture Collection (CCTCC) with a preservation number of CCTCC NO: M 2021941”.
Appropriate correction is required.
Public Availability of Biological Materials
Applicant provided the required public availability statement for Budapest Treaty deposit of strain Saccharomyces cerevisiae AMCC 30743 preservation number CCTCC M 2021941 on page 5 of the Remarks filed 13 July 2026.
Claim Rejections - 35 USC § 112
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.
(New necessitated by amendment) Claims 12 and 30-45 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 12 recites “the Saccharomyces cerevisiae AMCC 30743 strain” on line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites “inoculating the Saccharomyces cerevisiae AMCC 30743 strain into a YPD liquid culture medium for seed culture”. It is unclear if the term “seed culture” is intended to be an action, (i.e. seed culturing), or if the term is used to describe the yeast cell seed culture (a product) obtained by inoculating the Saccharomyces cerevisiae strain into a YPD liquid culture medium.
Claim 12 recites “adding the product obtained in step (1) to the YPD liquid culture medium and performing fermentation”. Step (1) does not recite a product of its inoculation, so it is unclear what product is being added in step (2). It is also unclear whether “the YPD liquid culture medium” recited in this limitation is intended to be the same YPD liquid culture medium used in step (1), or if it is a fresh YPD liquid culture medium in a separate culture vessel.
Claim 30 recites that the resulting yeast cells are obtained by culturing in a shake flask for 15-20 h to reach a biomass of 48-52 g/L. No subject is recited in the sentence “by culturing in a shake flask”, so it is not clear what is being cultured in a culture flask. The “resultant yeast cells” are obtained by the “culturing” action, but are not the object that the “culturing” action is being performed on. Claim 30 may be amended to: the method of claim 12, wherein the fermentation is performed by shaking the liquid culture in a flask for 15-20 hours to reach a biomass of 48-52 g/L.
Claims 33-35 recite that an intracellular succinic acid content of the resulting yeast cells is measured as a succinic acid content in a supernatant which is obtained after deionized water is added according to a mass volume ratio of the resulting yeast cells to the deionized water of 1:10 and cells are broken, and the succinic acid content in the supernatant is greater than 460 µg/mL. It is unclear if the claims are reciting an additional active step to the method of claim 12, and it is now unclear how many active steps are now required in the claimed method.
Claim 39 recites a yeast milk product. The specification defines the term “yeast milk” as yeast cells which were obtained by centrifugal removal of a supernatant from the fermentation broth obtained by fermentation, and then washing, suction filtration, pressing filtration, as well as separation and collection (specification pg. 5). However, the definition of a milk is a fluid secreted by the mammary glands of females for the nourishment of their young, or a drink made of that fluid. Milk is not added in claim 12 or in claim 39, and milk cannot be obtained from simply culturing yeast. It is therefore unclear if the yeast milk product actually comprises milk, or if the term “milk” is used to describe the resultant yeast cells produced by claim 12’s method.
Claims 30-45 are dependent on claim 12 and are indefinite for the same reasons.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(New necessitated by amendment) Claims 31-32 and 36-38 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 31-32 and 36-38 recite intended uses or characteristics of the resulting yeast produced by method of claim 12. These intended uses or characteristics are not further limiting any method step of claim 12. It is suggested that claims 31-32 and 36-38 be incorporated into the claims from which they depend or be canceled to obviate the rejection.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(New necessitated by amendment) Claims 39-45 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 39-45 are drawn to the statutory category of compositions of matter (Step 1: Yes).
Claim 39 recites a yeast milk product characterized in that it is obtained from claim 12’s method for fermentation preparation of the yeast 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. Milk is also a widely known naturally occurring liquid produced by mammals. The claim does not recite any other non-naturally occurring components.
Claim 40 recites a microbial agent obtained from claim 12’s method for fermentation preparation of the yeast Saccharomyces cerevisiae AMCC 30743 strain preservation number CCTCC No. M 2021941. As discussed above, Saccharomyces cerevisiae AMCC 30743 strain is a naturally occurring strain isolated from yogurt. 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. The claim does not recite any other non-naturally occurring components.
Claims 41-42 recite intended uses of claim 40’s microbial agent, but do not recite any additional composition elements.
Claim 43 recites a yeast extract obtained from claim 12’s method for fermentation preparation of the yeast Saccharomyces cerevisiae AMCC 30743 strain preservation number CCTCC No. M 2021941. As discussed above, Saccharomyces cerevisiae AMCC 30743 strain is a naturally occurring strain isolated from yogurt. 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.
Claims 44-45 recite intended uses of the yeast extract of claim 43, but do not recite any additional composition elements.
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 41-42 and 44-45 recite intended uses of the recited products of nature. However, none of these intended uses recite method steps which limit the invention to being used for a practical purpose.
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.
(New necessitated by amendment) Claims 12, 30-32, and 36-45 are rejected under 35 U.S.C. 103 as being unpatentable over Jing et al. (CN 108835363 A, published 20 November 2018) in view of Tao et al. (A Novel Strategy to Construct Yeast Saccharomyces cerevisiae Strains for Very High Gravity Fermentation, PLoS ONE, 1 February 2012, Volume 7, Issue 2, e31235).
Claim 12 recites the limitation “wherein the resulting yeast cells have an intracellular protein content of greater than 65 wt % of a dry weight of the resulting yeast cells and an RNA content of greater than 15 wt % of the dry weight of the resulting yeast cells”. This limitation is interpreted as intended properties of the resulting yeast cells recovered after practicing the method, but do not add any new method steps; thus, if the prior art teaches all of method steps of the claim invention, claims 12 will be considered to be rendered obvious.
Regarding claim 12, Jing teaches a method of fermenting a yeast culture medium with Saccharomyces cerevisiae 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 the yeast culture medium is YPD (yeast extract peptone dextrose medium).
Tao teaches YPD culture medium that is used as a fermenting medium for Saccharomyces cerevisiae (Tao pg. 2 sec Strains and Media, pg. 3 sec Fatty Acid and ergosterol analysis).
Jing and Tao do 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.
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 use Tao’s YPD fermentation medium in Jing’s method of fermenting a yeast culture medium with Saccharomyces cerevisiae because Tao teaches that YPD is a suitable fermentation medium for Saccharomyces cerevisiae fermentation, and Jing teaches their fermentation method is performed within a yeast culture medium. Thus, one of ordinary skill in the art would have found it predictably obvious to use Tao’s YPD medium as the culture medium in Jing’s method.
Regarding claim 30, Tao teaches culturing Saccharomyces cerevisiae in YPD medium with shaking for 20 hours (Tao pg. 3 sec Fatty Acid and ergosterol analysis). Although Tao does not specifically mention the culturing is performed within a shake flask, it is obvious to one of ordinary skill in the art that Tao’s culturing must occur within a container, such as a flask.
Jing and Tao do not teach to culture the Saccharomyces cerevisiae to the specific biomass of 48-52 g/L. However, it would have been obvious to one of ordinary skill in the art to optimize the final biomass of the resultant yeast cells in order to produce a desired concentration of yeast cells for further uses. MPEP §2144.05(II)(B) states “[i]n order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017).
Regarding claims 31-32, the claims recite the limitations “the resulting yeast cells have an intracellular glutamic acid content of greater than 9%”. The limitations are interpreted as being intended properties of the resulting yeast cells recovered after practicing the obvious method, but do not add any new method steps; thus, if the prior art teaches all of method steps of the claim invention, claims 31-32 will be considered to be rendered obvious.
Regarding claims 36-38, claim 36 recites that “the resulting yeast cells are used in the preparation of yeast extract”; claim 37 recites that “the resulting yeast cells are used in the preparation of feeds, food and health care products”; and claim 38 recites “that the resulting yeast cells are used in the preparation of condiments”. These limitations are interpreted as being intended uses of the of the resulting yeast cells recovered after practicing the method, but do not add any new method steps; thus, if the prior art teaches all of method steps of the claim invention, claims 36-38 will be considered to be rendered obvious.
Regarding claims 39-45, the BRI of a yeast milk in claim 39 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 specification defines the term “yeast milk” as yeast cells which were obtained by centrifugal removal of a supernatant from the fermentation broth obtained by fermentation, and then washing, suction filtration, pressing filtration, as well as separation and collection (specification pg. 5). Nowhere in this description is a milk component recited. The definition of a milk is a fluid secreted by the mammary glands of females for the nourishment of their young, or a drink made of that fluid. However, no such ingredient is added into the claimed “yeast milk”, and the Specification’s definition of “yeast milk” does not recite any milk component. The only ingredient recited is 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 microbial agent in claims 40-42 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 43-45 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.
The resultant fermented feed produced by Jing and Tao’s method is commensurate in scope with the BRI of the yeast milk, microbial agent, and yeast extract as recited in the claims as discussed in the BRI section above because Jing’s fermented feed contains the Saccharomyces cerevisiae cells and any compounds produced or isolated therefrom.
(New necessitated by amendment) Claims 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Jing and Tao as applied to claims 12, 30-32, and 36-45 above, and further in view of Jayaram et al. (Mapping of Saccharomyces cerevisiae metabolites in fermenting wheat straight-dough reveals succinic acid as pH-determining factor, Food Chemistry 136 (2013) 301–308) and Otero et al. (Industrial Systems Biology of Saccharomyces cerevisiae Enables Novel Succinic Acid Cell Factory, PLOS ONE, 1 January 2013, Volume 8, Issue 1, e54144).
Jing and Tao do not teach measuring intracellular succinic acid content of the resulting yeast cells a supernatant which is obtained after deionized water is added according to a mass volume ratio of the resulting yeast cells to the deionized water of 1:10 and cells are broken, and the succinic acid content in the supernatant is greater than 460 µg/mL.
Jayaram teaches the measurement of succinic acid present in the supernatants of Saccharomyces cerevisiae fermentation extract using a LC-20AT modular HPLC system, and that the supernatants were prepared by extraction in deionised water, centrifuged, and the supernatant was membrane filtered (Jayaram pg. 302 sec. 2.4 Characterization of fermenting dough).
Although Jayaram doesn’t teach that the deionized water is added in a mass volume ratio 1:10 of the resulting yeast cells to the deionized water, it would have been obvious to one of ordinary skill in the art to optimize the relative concentrations of deionized water and yeast cells in the supernatant to produce a supernatant with proportional and measurable volumes of succinic acid, whose predicted concentration would be optimal for measurement LC-20AT modular HPLC measurement system of Jayaram.
MPEP §2144.05(II)(B) states “[i]n order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017).
Furthermore, the limitation “the succinic acid content in the supernatant is greater than 460 µg/mL” is an intended property of the supernatant after practicing the obvious method step, but the limitation does not add any new method steps; thus, if the prior art teaches all of method steps of the claim invention, claims 33-35 will be considered to be rendered obvious.
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 measure the succinic acid content of Jing and Tao’s resultant yeast cells by using Jayaram’s method of measuring Saccharomyces cerevisiae produced succinic acid in a supernatant. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because succinic acid is known to be a highly sought after added-value chemical, as taught by Otero Abstract. Thus, one of ordinary skill in the art would find it desirable to measure the levels of succinic acid in their resultant fermentation produced by practicing claim 12’s obvious method in order to determine the concentration of the valuable succinic acid that is a widely sought after chemical.
Response to Arguments
Applicant’s arguments with respect to claim(s) 12 and 30-45 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Alexander M Duryee/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
Prosecution Insights