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 .
Support for the amendments is within the instant application specification.
Applicant’s amendment to the claims filed on 5/6/2026 in response to the Non-Final Rejection mailed on 2/5/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1, 3-4, 21-33 are pending.
Claims 2, 5-20 are canceled.
Applicant’s remarks filed on 5/6/2026 in response to the Non-Final Rejection mailed on 2/5/2026 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/12/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Withdrawn Claim Rejections - 35 USC § 112(a)
The scope of enablement rejection of claim 1 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn in view of Applicant’s amendment of claim 1 to recite ‘…contacting glucose with a galactose oxidase under conditions suitable to form an aldehyde intermediate; contacting the aldehyde intermediate or a derivative thereof with pyranose-2- oxidase under conditions suitable to produce a value-added chemical or a precursor to the value-added chemical, wherein the value-added chemical is selected from the group consisting of L-ascorbic acid, glucaric acid, 2- ketogluconate, succinic acid, 2,5-furan dicarboxylic acid, 2,5-furan dicarboxylic acid dimethyl ester, and combinations thereof.’
Withdrawn Claim Rejections - 35 USC § 112(b)
The rejection of claims 1, 8, 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of Applicant’s amendment of claim 1 to further define the recitation ‘value added chemical’ and cancellation of claims 8, 18.
Withdrawn Claim Rejections – 102(a1)
The rejection of claims 1, 8-16, 20 under 35 U.S.C. 102(a)(1) as being anticipated by Fraaije et al (WO 2019212351 A2, Date Published: 07 November 2019, cited on PTO-892 dated 2/5/2026) {herein Fraaije} is withdrawn in view of Applicant’s amendment of claim 1 to recite ‘…contacting glucose with a galactose oxidase under conditions suitable to form an aldehyde intermediate; contacting the aldehyde intermediate or a derivative thereof with pyranose-2- oxidase…’
The rejection of claims 1-7, 17-20 under 35 U.S.C. 102(a)(1) as being anticipated by Chappell (2013, Dissertation: The University of Leeds, School of Molecular and Cellular Biology, cited on PTO-892 dated 2/5/2026) {herein Chappell} is withdrawn in view of Applicant’s amendment of claim 1 to recite ‘…contacting glucose with a galactose oxidase under conditions suitable to form an aldehyde intermediate; contacting the aldehyde intermediate or a derivative thereof with pyranose-2- oxidase…’
New 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 24-26 are newly 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. The new rejection is necessitated by new claims 24-26.
MPEP 2163.II.A.2.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163 states 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. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Claim 24 is drawn to the process of claim 1, wherein the galactose oxidase comprises a mutant galactose oxidase having at least one mutation selected from Y405F, Q406E, A193R, D404H, F441Y,A172V, N66S, S306A, S311F, and Q486L. A mutant galactose oxidase with at least one mutation selected from Y405F, Q406E, A193R, D404H, F441Y,A172V, N66S, S306A, S311F, and Q486L encompasses a large number of sequences. Additionally, it is unclear if Applicant is referring to a full-length or a fragment of a mutant galactose oxidase since Applicant has not recited a specific SEQ ID NO.
Claims 25 is drawn to the process of claim 24, wherein the mutant galactose oxidase comprises mutations Y405F and Q406E. A mutant galactose oxidase with at least one mutation selected from Y405F, Q406E, A193R, D404H, F441Y,A172V, N66S, S306A, S311F, and Q486L and comprises mutations Y405F and Q406E encompasses a large number of sequences. Additionally, it is unclear if Applicant is referring to a full-length or a fragment of a mutant galactose oxidase since Applicant has not recited a specific SEQ ID NO.
Claim 26 is drawn to the process of claim 25, wherein the mutant galactose oxidase further comprises one or more mutations selected from A193R, D404H, F441Y, A172V, N66S, S306A, S311 F, and Q486L. A mutant galactose oxidase with at least one mutation selected from Y405F, Q406E, A193R, D404H, F441Y,A172V, N66S, S306A, S311F, and Q486L and further comprises one or more mutations selected from A193R, D404H, F441Y, A172V, N66S, S306A, S311F, and Q486L encompasses a large number of sequences. Additionally, it is unclear if Applicant is referring to a full-length or a fragment of a mutant galactose oxidase since Applicant has not recited a specific SEQ ID NO.
In this case, the specification discloses the following representative mutant galactose oxidase encompassed by the claims (i.e. mutant galactose oxidase comprising the amino acid sequence of SEQ ID NO: 15 with at least one mutation selected from Y405F, Q406E, A193R, D404H, F441Y,A172V, N66S, S306A, S311F, and Q486L and further comprises one or more mutations selected from A193R, D404H, F441Y, A172V, N66S, S306A, S311F, and Q486L). Other than the above disclosed species, there is no prior-art or disclosed teaching as to the large number of galactose oxidase mutants for determining polymer sequence information as encompassed by the claims.
In this regard, the reference of Singh et al. (Current Protein and Peptide Science, 2017; examiner cited) reviews various protein engineering methods and discloses that despite the availability of an every-growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by incomplete understanding of protein functions, folding, flexibility, and conformational changes [see p. 7, column 1, top]. The reference of Zhang et al. (Structure, 2018; examiner cited) discloses that a mutation of a residue that was predicted to be benign caused significant structural changes and unexpected effects on the function of a polypeptide [see p. 1475, column 1].
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004). Here, the disclosure fails to teach if the mutant galactose oxidase encompasses the full-length sequence or a fragment thereof.
Accordingly, one of skill in the art would not accept the disclosure of mutant galactose oxidase comprising one or more mutations selected from Y405F, Q406E, A193R, D404H, F441Y,A172V, N66S, S306A, S311F, and Q486L and further comprises one or more mutations selected from Y405F and Q406E or A193R, D404H, F441Y, A172V, N66S, S306A, S311F, and Q486L as encompassed by the claims, as being representatives of all mutant galactose oxidase enzymes. As such, the specification, taken with the pre-existing knowledge in the art of mutant galactose oxidase, fails to satisfy the written description requirement of 35 U.S.C. 112, first paragraph.
RESPONSE TO REMARKS: Applicants remarks filed on 5/6/2026 have been fully considered; however, they are rendered moot in view of the new rejection set forth above, which is necessitated by applicants’ amendment to the claims.
Maintained 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.
The provisional rejection of claims 1, 3-4, 21-23, 27-33 on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11, 13-16, 19-20, 22, 26-29 of copending Application No. 17/910,849. It is noted that the rejection of copending Application No. 17/790,923 in the non-final office action dated 2/5/2026 is withdrawn in view of Applicant’s amendment of claim 1 to recite ‘…contacting glucose with a galactose oxidase under conditions suitable to form an aldehyde intermediate; contacting the aldehyde intermediate or a derivative thereof with pyranose-2- oxidase under conditions suitable to produce a value-added chemical or a precursor to the value-added chemical, wherein the value-added chemical is selected from the group consisting of L-ascorbic acid, glucaric acid, 2- ketogluconate, succinic acid, 2,5-furan dicarboxylic acid, 2,5-furan dicarboxylic acid dimethyl ester, and combinations thereof’ which is patentably distinct from the instant application. Additionally, the rejection has been modified in view of Applicant’s amendment of claim 1 to recite ‘a molecular manufacturing process comprising: contacting glucose with a galactose oxidase under conditions suitable to form an aldehyde intermediate; contacting the aldehyde intermediate or a derivative thereof with pyranose-2- oxidase under conditions suitable to produce a value-added chemical or a precursor to the value-added chemical, wherein the value-added chemical is selected from the group consisting of L-ascorbic acid, glucaric acid, 2- ketogluconate, succinic acid, 2,5-furan dicarboxylic acid, 2,5-furan dicarboxylic acid dimethyl ester, and combinations thereof.’
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘849 are drawn to chemoenzymatic process for the preparation of 2,5-furan dicarboxylic acid, the process comprising: contacting D-glucose with galactose oxidase having an amino acid sequence of any of SEQ ID NO:1 to SEQ ID NO:6 and catalase to form D-glucodialdose (an aldehyde intermediate); contacting the D-glucodialdose with pyranose-2-oxidase having an amino acid sequence of any of SEQ ID NO.:7 to SEQ ID NO.:11 and catalase under conditions suitable for the formation of 2-keto-glucodialdose;contacting the 2-keto-glucodialdose or an intermediate with a metal catalyst and acid catalyst to form 2,5-furan dicarboxylic acid, wherein the metal catalyst comprises gold, platinum, ruthenium, palladium, iridium, osmium, rhodium, rhenium, silver, or combinations thereof, and wherein the acid catalyst comprises an ion exchange resin, sulfonated silica, a zeolite, niobium oxide, a mineral acid, or a combination thereof (claim 1); wherein the galactose oxidase has an amino acid sequence of SEQ ID NO.:1 (claim 11), which is not patentably distinct from the instant application claim 1 (claims 1, 3-4, 21-23, 27-33 dependent therefrom) of a molecular manufacturing process comprising: contacting glucose with a galactose oxidase under conditions suitable to form an aldehyde intermediate; contacting the aldehyde intermediate or a derivative thereof with pyranose-2- oxidase under conditions suitable to produce a value-added chemical or a precursor to the value-added chemical, wherein the value-added chemical is selected from the group consisting of L-ascorbic acid, glucaric acid, 2- ketogluconate, succinic acid, 2,5-furan dicarboxylic acid, 2,5-furan dicarboxylic acid dimethyl ester, and combinations thereof. The instant application further defines galactose oxidase as have at least 90% sequence identity to SEQ ID NO: 15, which is 96% similar to SEQ ID NO: 1 of ‘849 (recited in claim 11 of ‘849) (see appendix A).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. It is noted that at the time of filing the instant office action, a notice of allowance has been filed on 7/1/2026.
RESPONSE TO REMARKS: Applicants remarks filed on 5/6/2026 have been fully considered; however, they are rendered moot in view of the new rejection set forth above, which is necessitated by applicants’ amendment to the claims
Conclusion
Status of Claims
Claims 1, 3-4, 21-33 are pending.
Claims 2, 5-20 are canceled.
Claims 1, 3-4, 21-33 are rejected.
No claims are in condition for allowance.
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 ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656
Appendix A
Instant Application SEQ ID NO: 15 vs ‘849 SEQ ID NO: 1 (ABSS Alignment)
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