Prosecution Insights
Last updated: October 04, 2026
Application No. 17/790,923

COMPOSITIONS, SYSTEMS AND METHODS FOR PRODUCTION OF VALUE-ADDED CHEMICALS

Non-Final OA §112
Filed
Jul 05, 2022
Priority
Jan 06, 2020 — provisional 62/957,678 +7 more
Examiner
EPSTEIN, TODD MATTHEW
Art Unit
1652
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Solugen Inc.
OA Round
3 (Non-Final)
61%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allowance Rate
343 granted / 563 resolved
+0.9% vs TC avg
Strong +43% interview lift
Without
With
+43.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
46 currently pending
Career history
599
Total Applications
across all art units

Statute-Specific Performance

§101
7.7%
-32.3% vs TC avg
§103
31.8%
-8.2% vs TC avg
§102
14.6%
-25.4% vs TC avg
§112
31.0%
-9.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 563 resolved cases

Office Action

§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 . Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/02/2026 has been entered. Claim Objections Claims 21 and 30 objected to because of the following informalities: In claim 21, the conjunction “and” should appear between steps (a) and (b). In claim 30, a period must only appear at the end of the claim. As such, the following period should be removed: 10[Symbol font/0xB0] C. 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 21, 22 and 29-31 (all pending claims) 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. “New or amended claims which introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (an adequate description of a genus may not support claims to a subgenus or species within the genus)”; MPEP 2163(I)(B). “While there is no in haec verba requirement, newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure.” MPEP 2163(I)(B). “With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4 (Fed. Cir. 2007) (citing MPEP § 2163.04 which provides that a "simple statement such as ‘applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘___’ in the application as filed’ may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported."); see also MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure."); and MPEP § 2163.04.” MPEP 2163(II)(A). Claim 21 was amended on 06/02/2026 (upon entry of RCE) to recite “an acid catalyst at an initial pH in the range of from about 4 to about 7 to form an output comprising dihydroxyacetone.” In remarks dated 05/13/2026, applicant states: PNG media_image1.png 107 721 media_image1.png Greyscale From the cited portions of the specification, only para. [0076] appears to be related to a pH range as recited: “Once suitable enzymes have been identified through the screening process, a pressurized Parr bomb system will be used to mimic the reactor conditions at scale in order to assess the efficacy of converting an input (e.g., ethylene glycol) to a HVC (e.g., ethanolamine) using the disclosed processes. In a final volume of about 50 mL, biocatalysts at amounts ranging from about 0.001 percent weight by volume (w/v %) to about 1 w/v %will be combined with approximately 20 w/v % input (e.g., ethylene glycol) and a suitable buffer at an initial pH in the range of from about 4 to about 7. Catalase may be added to provide a ratio of from about 1:1 to 1:20 biocatalyst to catalase ratio to prevent accumulation of hydrogen peroxide. The mixture will be loaded into the Parr bomb containing a stir bar. To improve mass transfer of oxygen into the solution, the vessel will be sparged with oxygen two times, then pressurized to 100 psig. The reactor will be held at constant temperature, typically about 20 [Symbol font/0xB0]C but within the range of from about 10 [Symbol font/0xB0]C to about 80 [Symbol font/0xB0]C and the mixture allowed to react until the reaction is complete. During the reaction, the vessel may be depressurized to adjust the pH and obtain samples to assess conversion and product profile. Testing methods may include monitoring pH decrease as acids are produced, a colorimetric o-dianisidine assay to monitor formation of hydrogen peroxide, and HPLC for the detection of glycolaldehyde and EA.” As such, a pH range from about 4 to about 7 is discussed in the specification only in regards to a catalyst being an enzyme in a buffer having a pH from about 4 to 7. “Examples of acids or bases suitable for use as a finishing catalyst include without limitation hydrochloric acid, sulfuric acid, formic acid, sodium hydroxide and urea.” Specification, para. [0054]. As such, the broadest reasonable interpretation of acid catalyst does not include enzymes since the examples of acid catalysts given are all small-compound organic or inorganic acids and enzymes are not commonly referenced in the art as acid catalysts. Further, an ordinarily skilled artisan at time of filing would understand that employment of such acids in a catalytic manner would not include a neutral pH of about 7 or even mild acidic conditions of pH 4. As such, there is no disclosure in the specification that would allow for an ordinarily skilled artisan to recognized a description nor possession of acid catalysts employed at an initial pH range of from about 4 to about 7 as recited in amended claim 21. The support for the amendment to claim 21 wherein an acid catalyst (which is understood to exclude and not read on enzymes) has an initial pH from about 4 to about 7 does not have apparent support in the application and the portions of the specification referenced by the applicant do not provide written description support for the amendment for the reasons stated. As such, the amended claims (claim 21 and claims depending therefrom) introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement. New claim 30 is presented that recites “the method is performed at a temperature” from 10-80[Symbol font/0xB0]C. Claim 30 does not directly specify if the (a) contracting step, (b) contacting step or both of claim 21 must be performed at the recited temperature. However, since claim 30 recites “the method is performed at a temperature,” claim 30 is understood as requiring that the entirety of the method of claim 21 be performed at the temperature range of about 10 [Symbol font/0xB0]C to about 80[Symbol font/0xB0] C including step (b) of claim 21. The applicant in remarks appears to identify para. [0075] of the specification as providing support for new claim 30. However, para. [0075] of the specification only references “suitable enzymes” and “biocatalysts,” which are not an acid catalyst as discussed above. There is no apparent support in the application for performance of an acid catalyzed reaction as recited in step (b) of claim 21 at the recited temperature range of about 10 [Symbol font/0xB0]C to about 80[Symbol font/0xB0] C. As such, the new claim 30 introduces elements or limitations that are not supported by the as-filed disclosure violate the written description requirement. The rejection to claim 30 may be obviated by specifying the recited temperature range applies to step (a) of claim 21. Response to arguments In brief, applicant argues that the amendments obviate the prior grounds of rejection. However, applicant’s amendment necessitates the new grounds of rejection. Comment regarding prior art The closest prior art is cited in the prior Office Action. For production of dihydroxyacetone (DHA), the input must necessarily be glycerol transformed to glyceraldehyde as an oxidized intermediate that is then converted to DHA by the acid catalyst (see reaction scheme 4 of the specification). While glyceraldehyde is in equilibrium with DHA. Claim 21 is understood as requiring the presence of an acid catalyst (HCl, sulfuric acid, etc.) wherein effective employment of such a catalyst will in all reasonable instances result in a pH of less than 4. For example, the pH of a 0.1 mM solution of sulfuric acid will be approximately 3.7. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD M EPSTEIN whose telephone number is (571)272-5141. The examiner can normally be reached Mon-Fri 9:00a-5:30p. 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, Robert Mondesi can be reached at (408) 918-7584. 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. /TODD M EPSTEIN/Primary Examiner, Art Unit 1652
Read full office action

Prosecution Timeline

Jul 05, 2022
Application Filed
Jul 24, 2025
Non-Final Rejection mailed — §112
Oct 24, 2025
Response Filed
Feb 12, 2026
Final Rejection mailed — §112
May 13, 2026
Response after Non-Final Action
Jun 02, 2026
Request for Continued Examination
Jun 04, 2026
Response after Non-Final Action
Sep 15, 2026
Non-Final Rejection mailed — §112 (current)

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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
61%
Grant Probability
99%
With Interview (+43.4%)
2y 9m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 563 resolved cases by this examiner. Grant probability derived from career allowance rate.

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