Prosecution Insights
Last updated: August 06, 2026
Application No. 18/683,423

METHODS AND COMPOSITIONS FOR TREATING HYPERGLYCEMIA AND DIABETES

Non-Final OA §101§102§103§112§DP
Filed
Feb 13, 2024
Priority
Aug 13, 2021 — provisional 63/232,920 +1 more
Examiner
EIX, EMILY FAY
Art Unit
1653
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Anagram Therapeutics, Inc.
OA Round
1 (Non-Final)
52%
Grant Probability
Moderate
1-2
OA Rounds
1y 0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 52% of resolved cases
52%
Career Allowance Rate
15 granted / 29 resolved
-8.3% vs TC avg
Strong +70% interview lift
Without
With
+70.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
45 currently pending
Career history
95
Total Applications
across all art units

Statute-Specific Performance

§101
4.0%
-36.0% vs TC avg
§103
35.8%
-4.2% vs TC avg
§102
21.8%
-18.2% vs TC avg
§112
23.9%
-16.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 29 resolved cases

Office Action

§101 §102 §103 §112 §DP
DETAILED ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Election/Restrictions Applicant’s election without traverse of claims 1-6, 10, 15-16, and 18; and of the species functional fragment or variant thereof of a microbial glucose oxidase enzyme (claim 3a), a catalase enzyme (claim 3b), a combination of lactase, transglucosidase, and α-amylase (claim 3c), a functional fragment or variant of SEQ ID NO: 2 (claim 5b), SEQ ID NO: 4 (claim 5b) and a catalase enzyme (claim 10) in the reply filed on 5/11/2026 is acknowledged. Claims 20-21, 26-27, 42-46, and 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/11/2026. Applicant's election with traverse of the species of a powder (claim 16) in the reply filed on 5/11/2026 is acknowledged. The traversal is on the ground that searching and examining the species recited in claim 16 can be made without serious burden and is a reasonable number of species. This is not found persuasive because the instant application is a national stage application submitted under 35 U.S.C. 371, and therefore requires unity of invention analysis rather than the independent and distinct analysis required for applications filed under 35 U.S.C. 111(a). Applicant is directed to MPEP § 823. The unity of invention analysis does not require establishment of undue burden. The requirement is still deemed proper and is therefore made FINAL. Priority This application is a 371 of PCT/US2022/074932 (8/12/2022) which claims benefit of 63/232,920 (8/13/2021). Information Disclosure Statement The information disclosure statements (IDS) filed on 9/16/2024 and 5/11/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Drawings The drawings are objected to for the following reasons: 37 CFR 1.84(u)(1) states “View numbers must be preceded by the abbreviation “FIG.”. In the current case, the view numbers for Figures 1-6 are preceded by the word “Figure” instead of the abbreviation “FIG.”. View numbers should be updated to recite the abbreviation “FIG.”. Any changes to the drawings should also be reflected in the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. 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 3, 5, 10, and 18 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. Regarding written description, 35 U.S.C. 112(a) and the first paragraph of pre-AlA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention (MPEP § 2163(I)). MPEP 2163(II)(A)(3)(a)(i and ii) states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A "representative number of species" means that the species which are adequately described are representative of the entire genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., .759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Claim 3 recites a functional fragment or variant of a microbial glucose oxidase enzyme. Claim 5 recites that the glucose oxidase enzyme comprises a functional fragment or variant of an enzyme having SEQ ID NO: 2. There is not sufficient written description support for a functional fragment or variant of the glucose oxidase enzyme as claimed. The instant specification, pp. 7-8, recites exemplary embodiments of a functional fragment, specifically that a fragment of a full-length glucose oxidase retains, for example, at least 10% of the enzymatic activity. The instant specification additionally states on p. 7 that glucose oxidase includes variants having one or more amino acid substitutions, deletions, or insertions relative to a wild-type glucose oxidase sequence. However, there is not a disclosed relationship between structure and function for a functional fragment or variant. There is no disclosure of which positions or residues are critical for function, i.e. which regions can or cannot be mutated, deleted, inserted, or truncated in the enzyme sequence while still maintaining function. Further, there are no representative examples of glucose oxidase variants or functional fragments which maintain functional activity. As any number of modifications could be made to the glucose oxidase enzyme, there are countless possible fragments or variants, and there is not an established structure-function relationship to make clear which of these would be functional. For this reason, it is not clear that applicant was in possession of the full scope of the invention at the time of filing. Claim 10 is included in this rejection because it depends on a rejected claim and does not clarify the issue. Claim 18 recites the pharmaceutical composition of claim 1, wherein the composition has a shelf-life at room temperature of at least 3 months to 120 months. However, the specification does not provide adequate written description support for a composition comprising a glucose oxidase enzyme, a peroxide-degrading enzyme, and a pharmaceutically acceptable excipient with a shelf life of at least 3 months at room temperature. “Shelf-life” refers to retention of at least 30% of enzyme activity at room temperature during the specified duration of time (see instant specification p. 10 para. 49). It is known in the art that enzymes, including glucose oxidase and catalase, are easily degraded or deactivated, particularly at high temperatures (see Luo et al., CN110699346A p. 4 para. 5). Further, the formulation of the composition, i.e. liquid, lyophilized, etc.; or factors such as pH of the composition, impact the stability of the enzymes (see Luo p. 9 para. 11; Uppoor et al., Pharm Dev Technol. Fig. 5; instant specification p. 11 para. 50). The scope of claim 18 includes any formulation of the enzymes with any acceptable excipient, for example a liquid formulation of glucose oxidase, catalase, and water. There are no examples or data in the instant specification indicating that any composition as claimed would have the claimed shelf-life. There is no disclosure of structural features required for the composition to have the claimed shelf-life. As discussed above, various factors and conditions impact the shelf-life of an enzyme, and as taught by Uppoor, some glucose oxidase-catalase compositions lose enzyme activity before 3 months (e.g. pH 10 phosphate buffer, see Uppoor Fig. 5). Thus, it is expected that not all compositions comprising glucose oxidase, catalase, and an excipient, in any formulation, possess the claimed shelf-life at room temperature. As there are no representative examples of compositions having the claimed shelf-life, or disclosure of specific features of the composition required for such activity, it is not clear that applicant was in possession of the full scope of the invention at the time of filing. 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, 3-6, 10, 15, and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, product of nature, without significantly more. A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106: Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter? Yes. Claims 1, 3-6, 10, 15, and 18 are directed to a composition of matter. Step (2A): Prong 1: Does the claim recite a law of nature, natural phenomenon, or an abstract idea? Yes. Claim 1 recites a glucose oxidase enzyme, a peroxide-degrading enzyme, and a pharmaceutically acceptable excipient. Glucose oxidase and peroxidase-degrading enzyme are both natural products, derived from a microbe such as Aspergillus niger, which have not been modified. The pharmaceutically acceptable excipient is a product suitable for use in contact with the tissues of human beings and animals. Thus, for example, water is a pharmaceutically acceptable excipient (see instant specification p. 15 para. 62). Under broadest reasonable interpretation, claim 1 reads on a composition comprising three natural products, such as glucose oxidase, peroxide-degrading enzyme, and water. There is no indication that these products alone or in combination exhibit markedly different characteristics from their naturally occurring counterparts. Claim 3 specifies the type of glucose oxidase or peroxide-degrading enzymes, and enzymes which are not included in the composition, which are products of nature. Claims 4, 5, and 10 recite that the enzymes are microbial, derived from Aspergillus niger, and recites the enzyme sequences; these claims do not recite limitations aside from the natural product. Claim 6 recites the amount of enzyme present in the composition, however, the enzymes are natural products and there is no indication that these enzymes exhibit markedly different characteristics from their naturally occurring counterparts. Claim 15 recites that the composition is an oral dosage form. This reads on, for example, a liquid composition comprising glucose oxidase, peroxide-degrading enzyme, and water, and the claim is directed to a natural product. Claim 18 is directed to the shelf-life of the composition, which is a property of the composition. This still reads on a naturally-occurring composition which has the claimed functional feature. Prong 2: If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application? No. The claims are directed to combinations of naturally occurring enzymes and excipients. There is no recitation of additional limitations that integrate the composition into a practical application. Step (2B): If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly more than the judicial exception? No. Claims 1, 3-6, 10, 15, and 18 do not include additional elements that are sufficient to amount to significantly more than the judicial exception, as the claims are directed to a composition comprising multiple products of nature with no additional limitations. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1, 3-4, 6, 10, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hwang et al., US 2021/0177026 A1. Regarding claim 1, Hwang teaches a pharmaceutical composition comprising a glucose oxidase enzyme and a peroxide-degrading enzyme, catalase (Hwang p. 2 para. 26-27). Hwang teaches that the composition comprises a pharmaceutically acceptable carrier/excipient (Hwang p. 2 para. 35). Regarding claim 3, the use of "and/or" is interpreted to mean that only one of options (a), (b), and (c) is required, i.e. (a), (b), OR (c). Hwang teaches that (a) the glucose oxidase enzyme is a microbial glucose oxidase, produced from microorganisms (Hwang p. 2 para. 30). Hwang additionally teaches that (b) the peroxide-degrading enzyme is a catalase enzyme (Hwang p. 2 para. 26-27). Regarding claim 4, Hwang teaches that the enzymes of the composition (glucose oxidase and catalase) are enzymes produced from natural strains of fungi or yeasts, including Aspergillus niger (Hwang p. 2 para. 30; p. 3 para. 42 and 51). Regarding claim 6, the use of "and/or" is interpreted to mean that only one of options (a), (b), and (c) is required, i.e. (a), (b), OR (c). Hwang teaches that (b) the composition comprises 2,000 U of peroxide-degrading enzyme (catalase) (Hwang p. 4 Table 5). Hwang teaches that (c) the catalase has an activity 5 times higher than the activity of glucose oxidase, i.e. a ratio of 1 U glucose oxidase to 5 U catalase, or 0.2 (Hwang p. 2 para. 32). Regarding claim 10, Hwang teaches that the catalase is a microbial catalase, from Aspergillus niger (Hwang p. 2 para. 30; p. 3 para. 42 and 51). Regarding claim 15, Hwang teaches that the composition is orally administered, i.e. formulated as an oral dosage form (Hwang p. 4 para. 62). Claims 1 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Uppoor et al., Pharm Dev Technol. 1996 Jul;1(2):127-34. Regarding claim 1, Uppoor teaches a composition comprising glucose oxidase, catalase, and a pharmaceutically acceptable excipient, i.e. phosphate buffer (Uppoor Abstract, p. 130 col. 1 para. 4, col. 2 para. 7). Regarding claim 18, the instant specification states that “shelf-life” refers to, e.g., retention of at least 30% of enzyme activity at room temperature during the specified duration of time (see instant specification p. 10 para. 49). Uppoor teaches that the glucose oxidase-catalase composition is stored for up to 52 weeks at room temperature, or 23°C, in phosphate buffer with varying pH (Uppoor Fig. 5; p. 131 para. 4). Uppoor teaches compositions with a half-life (i.e. 50% of activity remaining) at room temperature of up to 52 weeks (Uppoor Figs. 5-6). Therefore, Uppoor teaches a composition comprising glucose oxidase, catalase, and a pharmaceutically acceptable excipient with a shelf-life of at least 12 months. 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 2 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang et al., as applied to claims 1, 3-4, 6, 10, and 15 above, in view of Luo et al., CN110699346A. Hwang teaches that the composition is orally administered, i.e. formulated as an oral dosage form (Hwang p. 4 para. 62). Hwang teaches that the enzyme composition of the present invention may be diluted by being mixed with a pharmaceutically acceptable carrier or formulated by being encapsulated in a container-shaped carrier depending on an administration method, dosage form, and treatment purpose by a conventional method (Hwang p. 2 para. 35). Hwang does not teach that the enzymes are lyophilized or spray-dried (claim 2), or that the oral dosage form is a powder (claim 16). Regarding claim 2, Luo teaches preparations of glucose oxidase in a lyophilized powder form (Luo para. 2). Luo teaches that glucose oxidase is used in the pharmaceutical industry and in food preparations, i.e. is able to be ingested orally (Luo para. 4). Regarding claim 16, Luo teaches glucose oxidase in powder form that is not easily degraded after freeze-drying and can be stored for a long time easily rehydrated, which is helpful for maintaining enzyme activity (Luo para. 5). Luo teaches that the lyophilized powder form of glucose oxidase is easy to store and transport which is convenient for biomedicine and food applications (Luo para. 32). It would have been obvious for a skilled artisan to modify the composition of Hwang and create a lyophilized powder of the enzyme composition. Both Hwang and Luo are directed to pharmaceutical compositions comprising glucose oxidase. Hwang teaches that the composition can be prepared in a variety of forms depending on administration method, dosage, or treatment purpose. Thus, it would have been obvious that the composition of Hwang could be prepared as a lyophilized powder composition as taught by Luo. A person of ordinary skill in the art would have been motivated to prepare the enzyme composition as a lyophilized powder because Luo teaches that glucose oxidase in lyophilized form has benefits including longer duration of storage, easier transport, and is convenient for biomedicine or food applications. Therefore, a skilled artisan would have been motivated to create a lyophilized powder form of the pharmaceutical composition as taught by Hwang to obtain these benefits. A skilled artisan would have had a reasonable expectation of success in making a lyophilized powder form of the composition as taught by Hwang because Luo teaches that glucose oxidase is lyophilized to provide numerous benefits. A skilled artisan could therefore expect that a composition comprising glucose oxidase as taught by Hwang could be lyophilized into a powder form, as this is an established technique in the art to create enzyme compositions that are easier to store and transport. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hwang et al., as applied to claims 1, 3-4, 6, 10, and 15 above, in view of Bocola et al., US 2016/0002609 A1. Regarding claim 5, the use of "and/or" is interpreted to mean that only one of options a) and b) is required, i.e. a) OR b). Bocola teaches glucose oxidase variants and pharmaceutical compositions comprising the variants (Bocola Abstract, p. 9 para. 122). Bocola teaches a) a glucose oxidase from Aspergillus niger with a sequence according to SEQ ID NO: 2, which is 100% identical to instant SEQ ID NO: 2, as well as variants of this glucose oxidase with increased enzyme activity and thermostability (Bocola pp. 2-3 para. 25, 37-38, pp. 19-20 SEQ ID NO: 2; Fig. 5-6; see sequence alignment in OA appendix). It would have been obvious to a skilled artisan that a glucose oxidase from Aspergillus niger with a sequence according to SEQ ID NO: 2 or a variant thereof could be used as the glucose oxidase in a composition according to Hwang. Hwang teaches that the glucose oxidase is derived from Aspergillus niger, but does not teach a sequence. It would have been obvious that the glucose oxidase taught by Hwang could be substituted with a glucose oxidase variant from the same microorganism, as taught by Bocola, having a wildtype sequence according to SEQ ID NO: 2. A person of ordinary skill in the art would have been motivated to make this substitution because Bocola teaches that the variants of the glucose oxidase have improved properties including increased enzyme activity and thermostability (Bocola Fig. 5-6 and 9). It therefore would be considered advantageous for a skilled artisan to incorporate an enzyme variant with improved properties in the pharmaceutical composition of Hwang. A skilled artisan would have had a reasonable expectation of success in making this substitution because Hwang teaches using a glucose oxidase from Aspergillus niger, and the variants taught by Bocola are also derived from Aspergillus niger. Therefore, a skilled artisan could expect to successfully substitute a glucose oxidase variant in place of the glucose oxidase of Hwang, as both are derived from the same species and have the same function. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1-6, 10, 15-16, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 10, 12, 15, 17, 19, and 21-22 of copending Application No. 18/683,426 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed to pharmaceutical compositions comprising a glucose oxidase enzyme, a peroxide-degrading enzyme, and a pharmaceutically acceptable excipient. Regarding instant claim 1, claim 1 of ‘426 recites a pharmaceutical composition comprising a glucose(xylose) isomerase enzyme, a glucose oxidase enzyme, a peroxide-degrading enzyme, and a pharmaceutically acceptable excipient. Regarding instant claims 2-6, 10, 15-16, and 18, the limitations of these dependent claims are recited in claims 1, 7, 10, 12, 15, 17, 19, and 21-22 of ‘426. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion Claims 1-6, 10, 15-16, and 18 are rejected. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET. 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. /EMILY F EIX/Examiner, Art Unit 1653 /SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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Prosecution Timeline

Feb 13, 2024
Application Filed
Jul 24, 2026
Non-Final Rejection mailed — §101, §102, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
52%
Grant Probability
99%
With Interview (+70.0%)
3y 5m (~1y 0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 29 resolved cases by this examiner. Grant probability derived from career allowance rate.

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