Prosecution Insights
Last updated: May 29, 2026
Application No. 18/266,213

HIGH PURITY HYDROXYCARBOXYLIC ACID COMPOSITIONS AND METHODS OF MAKING SAME

Non-Final OA §103§112
Filed
Jun 08, 2023
Priority
Dec 14, 2020 — provisional 63/125,306 +1 more
Examiner
MURESAN, ANA Z
Art Unit
1692
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Solugen Inc.
OA Round
1 (Non-Final)
75%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allowance Rate
536 granted / 711 resolved
+15.4% vs TC avg
Strong +31% interview lift
Without
With
+30.7%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
28 currently pending
Career history
743
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
59.0%
+19.0% vs TC avg
§102
8.1%
-31.9% vs TC avg
§112
14.2%
-25.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 711 resolved cases

Office Action

§103 §112
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 This Office action is responsive to Applicant's Response to Election/Restriction, filed March 16, 2026. As filed Claims 1-20 are pending. Priority This application filed 06/08/2023 is a National Stage entry of PCT/US2021/063202 , International Filing Date: 12/14/2021 PCT/US2021/063202 Claims Priority from Provisional Application 63125306, filed 12/14/2020. Information Disclosure Statement Applicants' information disclosure statements (IDS) have been considered except where lined through. Please refer to Applicants' copy of the 1449 submitted herein. Election/Restrictions Applicant’s election of Group II, claims 12-20 drawn to a process for producing glucaric acid in the reply filed on 03/16/2026 is acknowledged. Applicant’s elect the species of the Platinum-containing as first catalyst and the alpha-amylase- second catalyst and glucuronolactone as intermediate as described in paragraph [0040] of the specification The Applicants noted that that claims 12-14, 17-20 read on the elected species. Applicants’ elected species is not allowable due to the following rejections. Claims 1-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 15-16 are withdrawn from further consideration as being drawn to a nonelected species. Claims 12-14, 17-20 will be examined on the merits herein to the extend they read on the elected species. 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. Claims 12-14, 17-20 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. With respect to claim 12, the recitation “(d) contacting a second input” (emphasis added)” render the claim indefinite because it is unclear what that second input is pertaining to. Step (a) of the claimed method defines what the first input is selected from the group consisting of glucuronolactone, a disaccharide feedstock, a cleaved starch, a disaccharide, glucuronic acid, and a combination thereof. However, the second input can be interpreted to be the same Markush as the first input or a different one. As a result, one must refer back to the specification to define the claimed invention. The instant specification provides on pare [0016] of PgPub that the oxidized form of the first input 10 is introduced as a second input 30. Claims must, under modern claim practice, stand alone to define an invention. Ex parte Fressola, 27 USPQ 2d 1608 (1993). A claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear. Federal Register, Vol. 76, No. 27, February 9, 2011, 7162-7175, 7164. In the instant application, the second input of step d) has not been clearly defined. Consequently, claim 12 and its dependent claims 13-14, 17-20 are rendered indefinite. For examination purpose, the second input in step ) of the claimed method is interpreted as that the oxidized form of the first input resulted in step c). Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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 of this title, 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. Claims 12-14, 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. Green Chem., 2016, 18, 3815 (cited by Applicants in IDS) and further in view of Kobayashi et al J. Appl. Glycosci., Vol. 46, No. 1, p. 1-7 , 1999 (cited by Applicants in IDS) and Taketoshi et al. Applied Catalysis General Vol. 468, 2013, 453-458 (cited by Applicants in IDS). Instant claims are drawn to method for glucaric acid production, the method comprising: (a) providing a first input selected from the group consisting of glucuronolactone, a disaccharide feedstock, a cleaved starch, a disaccharide, glucuronic acid, and a combination thereof; (b) contacting the first input with a first catalyst system comprising a noble metal oxidation catalyst; (c) producing a first product based on the contacting in step (b); (d) contacting a second input with a second catalyst system comprising an enzyme; and (e) producing a second product comprising from about 50% to about 99% glucaric acid on a dry basis based on the contacting in step ( d). The article by Lee teach synthesis of glucaric acid (i.e. the compound of instant claims) by reacting glucose (cleaved starch) under different noble metal containing catalyst - including platinum (the elected species ) or gold/platinum (as recited instant claim 14), platinum/palladium catalysis as shown in scheme 2 on page 3815, table 3 page and results on Fig 1 page 3817 (instant claim 12). Example on page 3816 of the article by Lee teaches loading the reactor with glucose solution- which corresponds to step a of instant process, followed by containing with platinum base catalyst which corresponds to step b of instant process to produce gluconic acid - which corresponds to step c of instant process PNG media_image1.png 200 400 media_image1.png Greyscale PNG media_image2.png 200 400 media_image2.png Greyscale Regarding instant claim 13, disclosed on Table 3 on page 3820 is comparison of glucaric acid yields from glucose oxidation over different platinum based monometallic and bimetallic catalysts - the glucaric acid yield ranging from 74-28%- step e of instantly claimed process. Regarding instant claims 18-19, the prior art teaches glucaric acid as oxidation product and oxidized form of glucose- the first input. The method of the present application differs from the method described in the article by Lee in that prior art does teach step d of claimed process contacting of the oxidation product with enzyme for the formation of the same compound. However, it is noted that oxidation of glucose mediated by enzymes as alternative catalyst for the glucaric acid formation is discussed in the article by Kobayashi while the article by Taketoshi teaches aspects of synergetic combination of an enzyme and noble metal (e.g. gold) catalysts for glucose oxidation to sugar acids. Regarding the enzymatic oxidation for the glucaric acid formation, the article by Kobayashi teaches enzymatic catalysis of various substrates including glucuronolactone ( the elected species) with enzymes including glucose oxidase (instant claim 20) Table 2 on page 3, experimental on pages 4-6. PNG media_image3.png 200 400 media_image3.png Greyscale Regarding the combination of both chemical catalysts and enzymatic catalysts for increase in efficiency of oxidation of substrates, the publication by Taketoshi teaches synergetic combination of an enzyme and gold catalysts for glucose oxidation and specifically teaches that the combination of glucose oxidase with selected gold catalysts such as Au/ZrO2 led to improved catalytic performance in neutral solution at room temperature to form sugar acids as glucose oxidation products such as gluconic acid (abstract; Table 1 page 454; and results and discussion on page 455). PNG media_image4.png 200 400 media_image4.png Greyscale 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 Lee concerning preparation of glucaric acid by oxidation reaction of glucose with noble acid as catalyst with the teachings of Kobayashi and regarding utilizing enzymatic catalysis including glucose oxidase catalyst for glucaric acid formation and with the teachings of Taketoshi regarding combination of noble metal and enzyme catalysis for glucose oxidation, and have reasonable expectation of success in arriving at the claimed invention, because the prior art teach that combination of noble metal and enzyme catalysis for glucose oxidation as is an alternative route, shows a synergetic improvement in catalytic performance. Given that Taketoshi teach that the combination of an enzyme and noble metal (e.g. gold) catalysts for glucose oxidation results in a synergetic effect and in an improved catalytic performance, one of ordinary skill in the art would have been motivated to combine the teachings of prior art and to utilize both enzyme and noble metal catalysis in reaction glucose to glucaric acid instead of only noble metal catalyst as disclosed by Lee or only enzyme catalysts as disclosed by Kobayashi, with reasonable expectation of success. The rationale to support a conclusion that the claim would have been obvious is that teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. KSR, 550 U.S. at_, 82 USPQ2d at 1395. Thus, the claimed invention as a whole is prima facie obvious over the combined teachings of the prior art. Conclusion Claims 12-14, 17-20 are rejected. Claims 1-11, 15,16 are withdrawn from further consideration. Telephone Inquiry Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANA MURESAN whose telephone number is (571)-270-7587. The examiner can normally be reached on Monday through Friday, 8:30 am to 5:30 pm EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ANA Z MURESAN/Primary Examiner, Art Unit 1692
Read full office action

Prosecution Timeline

Jun 08, 2023
Application Filed
Apr 14, 2026
Non-Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
75%
Grant Probability
99%
With Interview (+30.7%)
2y 3m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 711 resolved cases by this examiner. Grant probability derived from career allowance rate.

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