DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 5, 6, 8-16, 27, and 29-41 are pending in the application.
Applicant's amendment to the claims, filed December 8, 2025, is acknowledged. This claim listing replaces all prior versions and listings of the claims.
Applicant’s remarks filed December 8, 2025 in response to the non-final rejection filed July 30, 2025 have been fully considered.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in a prior Office action.
Restriction/Election
In response to a requirement for restriction/election, applicant elected with traverse Group II, pending claims 5, 6, 8-16, 27, and 29-41, drawn to the technical feature of a process for producing 4-cyano benzoic acid or salt thereof and a method for making an aqueous solution, and species A1), SEQ ID NO: 2 encoded by SEQ ID NO: 1, in the reply filed July 10, 2023.
Claims 5, 6, 8-16, 27, and 29-41 are being examined on the merits with claims 5, 8, 27, and 36-41 being examined only to the extent the claims read on the elected species A1), SEQ ID NO: 2 encoded by SEQ ID NO: 1.
Claim Objections
Claims 36, 38, and 40 are objected to for reciting parts “a)” and “c)” without a part “b)” and in the interest of improving claim form, it is suggested that “c)” in claims 36, 38, and 40 be replaced with “b).”
Claim 40 is objected to because there is no conjunction between parts “a)” and “c)” and in the interest of improving claim form, it is suggested that the conjunction “and” be inserted immediately after part “a).”
Claim Rejections - 35 USC § 112(b)
Claims 37, 39, and 41 are newly rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. This rejection is necessitated by applicant’s amendments to claims 5, 8, and 27.
Each of claims 5, 8, and 27 has been amended to recite (in relevant part) a polypeptide having 90% identity to the amino acid sequence of SEQ ID NO: 2 or a polypeptide encoded by a nucleic acid sequence having 90% identity to the nucleic acid sequence of SEQ ID NO: 1. By this amendment, claims 37, 39, and 41 are indefinite in the recitation of a polypeptide having at least 95% identity to the amino acid sequence of SEQ ID NO: 2 in part b) or a polypeptide encoded by a nucleic acid sequence having at least 95% identity to the nucleic acid sequence of SEQ ID NO: 1 in part d) because claims 5, 8, and 27 do not encompass the recited ranges of percent identities. For example, by the amendments to claims 5, 8, and 27, these claims exclude a polypeptide having 95%, 96%, 97%, 98%, or 99% identity to the amino acid sequence of SEQ ID NO: 2. Applicant may consider amending claims 5, 8, and 27 to recite “at least” immediately before “90%.”
Claim Rejections - 35 USC § 112(a)
The rejection of claims 5, 6, 8-16, 27, and 29-41 under 35 U.S.C. 112(a) as failing to comply with the written description requirement is withdrawn in view of applicant’s amendment to the claims to limit the scope of nitrilases to comprising a polypeptide having 90% identity to the amino acid sequence of SEQ ID NO: 2 or a polypeptide encoded by a nucleic acid sequence having 90% identity to the nucleic acid sequence of SEQ ID NO: 1, applicant’s corresponding remarks at pp. 10-11, and upon further consideration of the rejection.
Claim Rejections – 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 8, 11, 12, 15, 16, 38, and 39 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,486,221 B2 (cited on the attached Form PTO-892). This rejection was previously a provisional rejection based on claims 1-14 of co-pending U.S. application no. 17/925,873. However, the 17/925,873 application has issued as U.S. Patent No. 12,486,221 B2 on December 2, 2025 and the rejection is no longer provisional. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 8, 38, and 39 of this application, the claims of the reference application are drawn to a process for preparing amidoxime compounds of formula I,
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wherein
R is halogen, C1-C4-alkyl, C1-C4-haloalkyl, C1-C4-alkoxy, or C1-C4-haloalkoxy;
n is 0, 1 or 2;
the process comprising
i. providing an aqueous medium comprising water, one or more nitrilase, and a terephthalonitrile of formula II, wherein the variables n and R have the meaning as defined for compound of formula I;
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ii. incubating the aqueous medium to obtain 4-cyanobenzoic acid of formula IIa or a salt thereof in an aqueous medium, wherein the variables n and R in 4-cyanobenzoic acid IIa have the meaning as defined for compound of formula I;
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iii. removal of biological material from the aqueous medium;
iv. treatment of the aqueous medium obtained in step iii with hydroxylamine or a salt thereof.
The claims of the reference application do not recite the sequence of the one or more nitrilase, however, according to MPEP 804.II.B.1, the specification can be used as a dictionary to learn the meaning of a term in the claim and the portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. Regarding a nitrilase for use in method of the claims of the patent, the specification of the patent discloses the nitrilase comprises a sequence defined or preferably defined in PCT/EP2020/051288 (paragraph [0016]; the instant application is a national stage of PCT/EP2020/051288) and the patent explicitly discloses only a single nitrilase, i.e., nitrilase from Comamonas testosteroni (see Examples 1 and 2) and SEQ ID NO: 2 of the instant application is the amino acid sequence of nitrilase from Comamonas testosteroni. As such, the nitrilase of the claims of the patent encompasses Comamonas testosteroni of SEQ ID NO: 2 of the instant application.
Regarding claim 11 of this application, claim 3 of the patent recites the process according to claim 1, wherein the terephthalonitrile II is added to the aqueous medium before incubation in a concentration between 1% and 30% by weight.
Regarding claim 12 of this application, claim 4 of the patent recites the process according to claim 1, wherein the aqueous medium in process steps i and ii has a pH value of 4 to 9.
Regarding claim 15 of this application, claim 5 of the patent recites the process according to claim 1, wherein the aqueous medium in step ii is incubated at a temperature in the range of from 10° C to 50° C.
Regarding claim 16 of this application, the recitation of “wherein the nitrilase is produced by fermentation” is a product by process limitation and does not structurally and/or functionally distinguish over the nitrilase recited in claim 1 of the patent.
Therefore, claims 8, 11, 12, 15, 16, 38, and 39 of this application are unpatentable over claims 1-14 of the patent.
Claims 5, 6, 13, 14, 36, and 37 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,486,221 B2 (cited on the attached Form PTO-892) in view of Zhang et al. (Process Biochemistry 75:152-156, 2018; cited on Form PTO-892 mailed on September 7, 2023; hereafter “Zhang”). This rejection was previously a provisional rejection based on claims 1-14 of co-pending U.S. application no. 17/925,873. However, the 17/925,873 application has issued as U.S. Patent No. 12,486,221 B2 on December 2, 2025 and the rejection is no longer provisional. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the reference application as applied to instant claims 8, 11, 12, 15, 16, 38, and 39 are described above.
Regarding instant claims 5, 6, 13, 14, 36, and 37, the claims of the reference application do not recite the concentrations of terephthalonitrile and 4-cyanobenzoic acid as recited in instant claims 5 and 6, and do not recite the limitations of instant claims 13 and 14.
Regarding instant claims 5 and 6, Zhang teaches a process for a nitrilase-catalyzed conversion of terephthalonitrile to 4-cyanobenzoic acid (p. 15, columns 1-2). Zhang does not explicitly teach the concentrations of 4-cyanobenzoic acid, terephthalonitrile, and terephthalic acid following the conversion. However, Zhang teaches that up to 100 g/L of terephthalonitrile was completely converted to 4-cyanobenzoic acid (p. 155, column 2, bottom) and therefore, by practicing Zhang’s process, the concentration of 4-cyanobenzoic acid is at least 5% (w/w), the concentration of terephthalonitrile is below 1.0% (w/w), and the concentration of terephthalic acid is below 0.5% (w/w) following the conversion. Since the Office does not have the facilities for examining and comparing applicants’ process with the process of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed process and the process of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Regarding instant claim 13, Zhang teaches extracting the product by centrifugation (p. 153, columns 1-2).
Regarding instant claim 14, the reaction times are greater than 2 hours (p. 153, columns 1-2; e.g., 12 hours).
In view of the teachings of Zhang, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of the claims of the patent according to Zhang. One would have been motivated to and would have had a reasonable expectation of success because the claims of the patent and teachings of Zhang are both related to processes for a nitrilase-catalyzed conversion of terephthalonitrile to 4-cyanobenzoic acid.
Therefore, claims 5, 6, 13, 14, 36, and 37 of this application are unpatentable over claims 1-14 of the patent in view of Zhang.
Claims 9, 10, 27, 29-35, 40, and 41 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,486,221 B2 (cited on the attached Form PTO-892) in view of Zhang as applied to claims 5, 6, 8, 11-16, and 36-39 above, and further in view of Chen et al. (J. Microbiol. Biotechnol. 25:1660-1669, 2015; cited on Form PTO-892 mailed on September 7, 2023; hereafter “Chen”). This rejection was previously a provisional rejection based on claims 1-14 of co-pending U.S. application no. 17/925,873. However, the 17/925,873 application has issued as U.S. Patent No. 12,486,221 B2 on December 2, 2025 and the rejection is no longer provisional. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the patent as applied to instant claims 5, 6, 8, 11-16, and 36-39 are described above.
The claims of the patent do not recite a divalent cation as recited in claims 9, 10, 27, and 29 of this application.
Regarding instant claims 9, 10, 27, 29, 40, and 41, Chen teaches Mg2+ and Fe2+ enhanced nitrilase activity (p. 1665, column 1, bottom and Table 1).
In view of the additional teachings of Chen, it would have been obvious to one of ordinary skill in the art before the effective filing date to further modify the process of the claims of the patent to include Mg2+ and Fe2+ in the aqueous medium. One would have been motivated to and would have had a reasonable expectation of success to do this because Chen taught Mg2+ and Fe2+ enhanced nitrilase activity.
Regarding claim 30, Zhang teaches adding terephthalonitrile to an aqueous buffer (p. 153, columns 1-2), the concentration of terephthalonitrile is within the range of 1% and 30%.
Regarding claim 31, Zhang teaches acidifying the reaction mixture by adding 6 M HCl to a pH of 1-2 (e.g., p. 153, column 2, bottom).
Regarding claim 32, Zhang teaches extracting the product by centrifugation (p. 153, columns 1-2).
Regarding claim 33, the reaction times are greater than 2 hours (p. 153, columns 1-2; e.g., 12 hours).
Regarding claim 34, the temperature of Zhang’s reaction is within the range of 15oC and 50oC (p. 153, columns 1-2; e.g., 30oC).
Regarding claim 35, Zhang teaches the reaction is performed using nitrilase enzyme produced by E. coli or Pantoea cells (p. 153, columns 1-2).
Therefore, claims 9, 10, 27, 29-35, 40, and 41 of this application are unpatentable over claims 1-14 of the patent in view of Zhang and Chen.
RESPONSE TO REMARKS: Applicant argues the provisional rejection should be withdrawn in accordance with MPEP 804.I.B.1.(b).(i).
Applicant’s argument is not found persuasive because the rejection is not the only remaining rejection and is no longer a provisional rejection.
Conclusion
Status of the claims:
Claims 5, 6, 8-16, 27, and 29-41 are pending.
Claims 5, 6, 8-16, 27, and 29-41 are rejected.
No claim is 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 DAVID J STEADMAN whose telephone number is (571)272-0942. The examiner can normally be reached Monday to Friday, 7:30 AM to 4:00 PM.
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/David Steadman/Primary Examiner, Art Unit 1656