Prosecution Insights
Last updated: September 17, 2026
Application No. 19/202,536

ENZYME FOOD FOR MAINTAINING BODY BALANCE AND PREVENTING METABOLIC SYNDROME THROUGH ENZYMES

Final Rejection §101§103§112
Filed
May 08, 2025
Priority
Dec 05, 2024 — RE 10-2024-0179066
Examiner
AFREMOVA, VERA
Art Unit
1653
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Apharm Health Co. Ltd.
OA Round
2 (Final)
51%
Grant Probability
Moderate
3-4
OA Rounds
2y 3m
Est. Remaining
80%
With Interview

Examiner Intelligence

Grants 51% of resolved cases
51%
Career Allowance Rate
445 granted / 880 resolved
-9.4% vs TC avg
Strong +29% interview lift
Without
With
+29.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
57 currently pending
Career history
949
Total Applications
across all art units

Statute-Specific Performance

§101
8.2%
-31.8% vs TC avg
§103
46.1%
+6.1% vs TC avg
§102
18.7%
-21.3% vs TC avg
§112
21.5%
-18.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 880 resolved cases

Office Action

§101 §103 §112
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 claims Claims 1, 8 as amended and new clams 10-12 as filed on 7/27/2026 are pending and under examination. Claim Objections Claims 8 and 11 are objected to because of the following informalities: Latin names of microorganisms should be italicized. Appropriate correction is required. Claim Rejections - 35 USC § 112 Claims 1,8 as amended and new claims 10-12 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 as amended is indefinite with regard to contents of several components of the composition due to overlapping meaning of the claim-recited phrases. For example: there are several “powder(s)” including “a powder preparation”, “amino acid mixture powder”, “vinegar powder”, “lactic acid bacteria mixture powder”. However, the differences between theses components are not clear as recited in the claims. The claimed-recited “a powder preparation” might or might not comprise any other claim-recited powders unless the exact powder ingredients are clearly recited in the claims. Further, even in the light of specification definitions, the intended ingredients are the same for the different components. For example: “vinegar powder” is said to contain amino acids (see specification page 9, line 30); thus, the differences, if any, between “amino acid mixture powder” and “vinegar powder” are uncertain as recited in the claims when read in the light of generic definitions in the as-filed specification. Furthermore, “gluten-degrading lactic acid bacteria” component and “lactic acid bacteria mixture powder” components appear to be same because both are “lactic acid bacteria” as claimed and they comprises the same species including Lactobacillus plantarum , Lactobacillus acidophilus, Lactobacillus rhamnosus in view of specification (see page 10, lines 8-14) and as claimed (see claim 8). Thus, the metes and bounds of the claims cannot be determined as claimed and in view of generic definitions of specification. Therefore, specific amounts of components with uncertain and/or same ingredients recited in the claims 1 and 12 have no meaning. Claim 10 is indefinite because it excludes several components of the composition of preceding claim 1 and limited to only 3 components as recited therein (100=50+20+30). Claim 12 recites amounts of apple powder and licorice concentrate powder but apple powder and licorice concentrate powder are not recited in claim 1. Thus, there is insufficient antecedent basis for these limitations in the claim. 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. Claims 1, 8 as amended and new clams 10-12 remain/are rejected under 35 U.S.C. 103 as being unpatentable over commercial product “BOTO Tef Fermentation Enzyme Grain” (on sale Sep 25, 2024) in view of US 5,250,301 (Dozono), US 8,318,218 (Mortensen), US 4,496,606 (Michnowski), US 11,426,353 (Jin et al) and Stacewicz-Sapuntzakis et al (Critical Review in Food Science and Nutrition. 2001, 41(4), pages 251-286). The cited product “ BOTO Tef Fermentation Enzyme Grain” is an enzyme food composition for improving digestion, wherein the product comprises: teff fermented enzyme, powder preparation (maltodextrin, Aspergillus oryzae or brown rice, for example), dextrin, fructo-oligosaccharides, isolated soy protein, flavor, amino acid mixture powder (in a form of bean powder, for example), salt (potassium phosphate, for example) psyllium husk, chicory extract; and mixed probiotic powder. Thus, the cited product comprises same ingredients as claimed but it is lacking stevia, licorice and guar gum. However, these ingredients have been knonw and used in food composition for improving digestion. For example: US 5,250,301 (Dozono) discloses a medicinal composition with stevia extract for improving digestion (see abstract). For example: US 8,318,218 (Mortensen) discloses a composition for improving digestion with licorice extract (col. 5, lines 26-31). For example: US 4,496,606 (Michnowski) teaches incorporation of guar gum into food composition for improving digestion and controlling blood sugar with guar gum 48-53). Although the BOTO product description does not explicitly recognize incorporation of malic acid, the prune juice powder and plum concentrate powder that are incorporated into the cited product contain malic acid (see table 1, page 255 of the reference by Stacewicz-Sapuntzakis). Further, the cited BOTO product clearly contains “mixed probiotic powder” but does not explicitly describe probiotic as lactic bacteria or as various species of Lactobacillus. However, lactic bacteria are commonly used as probiotic in food compositions for improving digestion including all claim-7-recited Lactobacillus species; for example: see US 11,426,353 (Jin et al) at col. 3, lines 47-50). Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to include additional components to the BOTO teff enzyme product with a reasonable expectation of success in improving digestion because all claim-recited components have been clearly recognized, knonw and used in the prior art food and medicinal products for the same benefits in improving digestion. Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary. The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103. 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, 8 as amended and new clams 10-12 remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim recites a composition with several components including teff enzyme, powders with grains and lactic bacteria, proteins, amino acid, plant extract, etc, wherein all claim-recited components are natural products. Thus, the claimed mixture is a simple mixture of all natural products without significant transformation providing for a marked difference from natural counterparts. This judicial exception is not integrated into a practical application because claimed elements in combination do not add a meaningful limitation or extra-solution to the claimed product, and the claimed product as a whole is nothing more than an attempt to generally link the product of nature to a particular technological environment. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception. Response to Arguments Applicant's arguments filed 7/27/2026 have been fully considered but they are not persuasive. With regard to claim rejection under 35 U.S.C. 103 Applicants’ arguments are based on unexpected and synergistic effects (flavor, aroma, color, texture) of the claimed composition with specific amounts of specific components as claimed as shown in specification tables 2 and 4. The arguments are not found persuasive because the scope of the showing must be commensurate with the scope of claims to consider evidence probative of unexpected results, for example. In re Dill, 202 USPQ 805 (CCPA, 1979), In re Lindner 173 USPQ 356 (CCPA 1972), In re Hyson, 172 USPQ 399 (CCPA 1972), In re Boesch, 205 USPQ 215, (CCPA 1980), In re Grasselli, 218 USPQ 769 (Fed. Cir. 1983), In re Clemens, 206 USPQ 289 (CCPA 1980). It should be clear that the probative value of the data is not commensurate in scope with the degree of protection sought by the claim. It is recognized that unexpected effect or synergism is a highly unpredictable result that is very dependent on the ingredients used and the amounts of each. In the instant case, the specific ingredients in the claimed components that provided for effects as argued are uncertain as explained above. Therefore, specific amounts of components with uncertain and/or same ingredients recited in the claims 1 and 12 have no meaning. Further, Applicants appear to argue that amounts of apple powder and licorice, in particular, provide for better sensory evaluation scores of flavor, aroma, etc. However, these components are not even present in the composition of claim 1. Thus, any combination for which unexpected effect or synergism is not clearly established would be properly rejected because non-obviousness would not have been established. With regard to claim rejection under 35 U.S.C. 101 Applicants argue that the quantitative constrains and resulting effects of the claimed product provide significantly more than any alleged exception. Yet, since ingredients are not clearly defined in the claims and their combinations are overlapping, the amounts have no meaning as claimed. The claimed product is considered as a simple mixture of all-natural components. No claims are allowed. Conclusion THIS ACTION IS MADE FINAL. 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 VERA AFREMOVA whose telephone number is (571)272-0914. The examiner can normally be reached Monday-Friday: 8.30am-5pm 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, Sharmila Landau can be reached at (571) 272-0614. 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. Vera Afremova August 11, 2026 /VERA AFREMOVA/ Primary Examiner, Art Unit 1653
Read full office action

Prosecution Timeline

May 08, 2025
Application Filed
Mar 27, 2026
Non-Final Rejection mailed — §101, §103, §112
May 29, 2026
Response Filed
May 29, 2026
Response after Non-Final Action
Jul 07, 2026
Response after Non-Final Action
Jul 07, 2026
Response Filed
Jul 27, 2026
Response Filed
Aug 13, 2026
Final Rejection mailed — §101, §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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Patent 12660736
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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
51%
Grant Probability
80%
With Interview (+29.1%)
3y 7m (~2y 3m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 880 resolved cases by this examiner. Grant probability derived from career allowance rate.

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