Prosecution Insights
Last updated: April 19, 2026
Application No. 17/798,415

CHONDROITINASE ABC MUTANTS AND METHODS OF MANUFACTURE AND USE THEREOF

Final Rejection §101§102§103§112
Filed
Aug 09, 2022
Examiner
RAGHU, GANAPATHIRAM
Art Unit
1652
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Yeda Research And Development Co. Ltd.
OA Round
2 (Final)
74%
Grant Probability
Favorable
3-4
OA Rounds
2y 8m
To Grant
99%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allow Rate
944 granted / 1285 resolved
+13.5% vs TC avg
Strong +26% interview lift
Without
With
+26.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 8m
Avg Prosecution
39 currently pending
Career history
1324
Total Applications
across all art units

Statute-Specific Performance

§101
2.1%
-37.9% vs TC avg
§103
44.1%
+4.1% vs TC avg
§102
10.5%
-29.5% vs TC avg
§112
10.0%
-30.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1285 resolved cases

Office Action

§101 §102 §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 . Application Status In response to Non-Final-Office Action mailed on 04/24/2025, applicants’ response dated 06/26/2025 is acknowledged; in said response applicants’ have amended claims 1, 3 and 17, canceled claim 8 and added new claims 39-40. Thus, amended claims 1, 3-7, 9-10, 13-14, 17, 20-28, 30 and 38-40 are pending in this application; claims Group I, claims 1, 3-5, 9-10, 17, 20-21, 26 and 39-40 and the polypeptide sequence of SEQ ID NO: 1 comprising 18 substitutions (as in claim 10(a)) and the elected species reading on the elected invention is now under consideration for examination; non-elected combination of mutations in claim 10(a)-(c) and claims 6-7, 13-14, 22-25, 27-28, 30 and 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim. Rejections and/or objections not reiterated from previous office action are hereby withdrawn. New-Claim Objections Claims 9-10 are objected to, due to the following informality: claims 9-10 depend from canceled claim 8. New-Matter/Objection to Specification Necessitated by claim amendments Upon further review of claims amendment; amended claim 3 and claims 4-5, 17 and 39-40 depending therefrom (dated 10/24/2025) are objected to under 35 U.S.C. 132(a), because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: Amended claim 3 recites and domain 3 consists of amino acid residues 623-882 of SEQ ID NO: 1” and broadens the scope of the claims and as claimed was not contemplated in the specification as originally filed dated 08/09/2022 or in the original claim set dated 08/09/2022. The instant amended claim 3 and claims 4-5, 17 and 39-40 depending therefrom (dated 10/24/2025) as interpreted encompass new-matter. New Matter-Claim Rejections: 35 USC § 112 (a) Necessitated by claim amendments Amended new claim 3 and claims 4-5, 17 and 39-40 depending therefrom (dated 10/24/2025) are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA )/new-matter, 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(s), at the time the application was filed, had possession of the claimed invention. Amended claim 3 recites and domain 3 consists of amino acid residues 623-882 of SEQ ID NO: 1” and broadens the scope of the claims and as claimed was not contemplated in the specification as originally filed dated 08/09/2022 or in the original claim set dated 08/09/2022. The instant amended claim 3 and claims 4-5, 17 and 39-40 depending therefrom (dated 10/24/2025) as interpreted encompass new-matter and broadens the scope of the claims and as claimed was not contemplated in the specification as originally filed dated 05/25/2022 or in the original claim set dated 05/25/2022; see Purdue Pharma L.P. v. Faulding Inc., 230 F .3d 1320, 1326, 56 USPQ2d 1481, 1486 (Fed. Cir. 2000). The court noted that with respect to In Re Rusching 379 F.2d 990, 154 USPQ 118 (CCPA 1967) that “Rusching makes clear that one cannot disclose a forest in the original application, and then later pick a tree out of the forest and say “here is my invention”. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure”. New-Claim Rejections: 35 U.S.C. 112(d) Necessitated by claim amendments The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 9-10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 9-10 recites “…the mutant of claim 8”; claim 8 is and dependent claims 9-10 does not further limit canceled claim 8. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. The U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of pre-AIA 35 U.S.C. 112, 4th paragraph, are related to matters of form, non-compliance with pre-AIA 35 U.S.C. 112, 4th paragraph, renders the claim unpatentable just as non-compliance with other paragraphs of 35 U.S.C. 112 would. See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92, 79 USPQ2d 1583, 1589-90 (Fed. Cir. 2006) (holding a dependent claim in a patent invalid for failure to comply with pre-AIA 35 U.S.C. 112, 4th paragraph). Therefore, if a dependent claim does not comply with the requirements of 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, the dependent claim should be rejected under pre-AIA 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as unpatentable rather than objecting to the claim. See also MPEP § 608.01(n),subsection III, “Infringement Test” for dependent claims. New-Claim Rejections: 35 USC § 101 Necessitated by claim amendments 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, 3-5, 9 and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea). Claims 1, 3-5, 9 and 26 are directed to a law of nature or a natural phenomenon. Claims 1, 3-5, 9 and 26 as interpreted are directed to any "mutant” of a wild-type chondroitinase ABC (ChABC) wherein the wild-type ChABC comprises the amino acid sequence of SEQ ID NO:1 or an amino acid sequence that is homologous to the amino acid sequence of SEQ ID NO:1, and wherein when the homologous amino acid sequence is aligned with the sequence of SEQ ID NO:1 it has a BLAST expectation value of less than 1e50 and comprising substitutions of amino acid residues to positions of K224E, Q246L… N300D… S437G, and D599G; (also see claims objections, 35 U.S.C. 112(a) and 35 U.S.C. 112(d) rejections above for claims interpretation).The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons stated below. The “2014 Interim Guidance on Patent Subject Matter Eligibility” 79 FR 74618 (Dec. 16, 2014) directs that claims drawn to 1) a composition of matter, 2) a law of nature or a natural phenomenon and 3) lacking recitation of additional elements that make the claims directed to significantly more than a judicial exception are ineligible for patenting under 35 U.S.C. 101. See, 79 FR, page 74621 (flow chart). Nature-based compositions of matter are not directed to significantly more than a judicial exception when the claimed "naturally occurring products and some man-made products ... are essentially no different from a naturally occurring product ... that fall under the laws of nature or natural phenomena exception.” 79 FR, page 74623, left column. That is, a patent-eligible composition of matter must be "markedly different" in terms of the "product's structure, function, and/or other properties." 79 FR, page 74623, center column. Further, processes directly to isolating nature-based compositions of matter have also been found to be directed to nothing more than a judicial exception when only routine purification techniques are employed. 79 FR, page 74622, center column (e.g. isolating DNA or other nature-based products). Here, naturally-occurring variant polypeptides comprising at least 31 mismatches and substitution of an amino acid at position N300D… S437G equivalent to a position in a chondroitinase ABC (ChABC) corresponding to SEQ ID NO: 1, said naturally-occurring mutants having a sequence identities ranging from 94.6%, 94.5%, 94.1%, 93.9%, 93.2% respectively is disclosed by the following references: UniProtKB/TrEMBL Accesion#A0A8I0WQ34 Harrison et al.,; UniProtKB/TrEMBL Accesion#A0A6G6SKD3, Peng et al.,; UniProtKB/TrEMBL Accesion#A0A6G6TFS5, Peng K.,; UniProtKB/TrEMBL Accesion#A0A6I7DBI9, He et al.,; UniProtKB/TrEMBL Accesion#A0A0G4Q5T7; and UniProtKB/TrEMBL Accesion#A0AAW7CIU5, Li et al., and said reference mutants further comprising multiple substitutions corresponding to positions in SEQ ID NO: 1 of the instant application, which can be considered naturally occurring variants of SEQ ID NO: 1 (see provided sequence alignment). The features of claims 1, 3-5, 9, 17 and 26 are met by the reference polypeptides of SEQ ID NO: 1 in the disclosed references above; applicants are also directed to the following references; UniProtKB/TrEMBL Accesion#A0A8I0WQ34 Harrison et al.,; UniProtKB/TrEMBL Accesion#A0A6G6SKD3, Peng et al.,; UniProtKB/TrEMBL Accesion#A0A6G6TFS5, Peng K.,; UniProtKB/TrEMBL Accesion#A0A6I7DBI9, He et al.,; UniProtKB/TrEMBL Accesion#A0A0G4Q5T7; and UniProtKB/TrEMBL Accesion#A0AAW7CIU5, Li et al., that disclose naturally occurring variants having sequence identities ranging from 94.6%, 94.5%, 94.1% 93.9%, 93.2% (see provided sequence alignment). Since the features of the claims are met by the structure of a polypeptide of SEQ ID NO: 1 or homolog of SEQ ID NO: 1 and the claims do not recite additional features or elements that amount to significantly more than the judicial exception, since the structure recited in claims 1, 3-5, 9 and 26 is "essentially no different from a naturally occurring product” such that there is no marked difference in the "product's structure, function, and/or other properties. As such, the claims 1, 3-5, 9 and 26 recite patent ineligible subject matter for the reasons stated. New-Claim Rejections: 35 USC § 102 (AIA ) Necessitated by claim amendments 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. 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. Claims 1, 3-5, 9, 20, 26 and 39-40 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Prabhakar et al., (US 7,507,570). Claims 1, 3-5, 9, 20, 26 and 39-40 as interpreted are directed to any "mutant” of a wild-type chondroitinase ABC (ChABC) wherein the wild-type ChABC comprises the amino acid sequence of SEQ ID NO:1 or an amino acid sequence that is homologous to the amino acid sequence of SEQ ID NO:1, and wherein when the homologous amino acid sequence is aligned with the sequence of SEQ ID NO:1 it has a BLAST expectation value of less than 1e50 and comprising substitutions of amino acid residues to positions of K224E, Q246L… N300D… S437G, and D599G; (also see claims objections, 35 U.S.C. 112(a) and 35 U.S.C. 112(d) rejections above for claims interpretation). Prabhakar et al., (US 7,507,570) disclose wild-type chondroitinase ABC (ChABC) having 100% sequence identity to SEQ ID NO: 1 of the instant invention, homologs and variants of said having sequence identities of 99.1%, 93.1% to SEQ ID NO: 1 of the instant invention and variants comprising the following amino acid substitutions/point mutations, Q636G, Q665G, E694P, Q731G, Q736G, N738D, Q810G, Q814G as compared to SEQ ID NO: 1 of the instant invention (see provided sequence alignments); examiner takes the position that structure and function are inseparable and the variants disclosed by Prabhakar et al., (US 7,507,570) inherently possess al the claimed biochemical properties of the instant invention. Prabhakar et al., (US 7,507,570) also disclose fusion proteins of said chondroitinase ABC (ChABC) and pharmaceutical compositions; also provided herein are drug delivery strategies of cABC I and its modified counterparts; these include fusion proteins, where the cABC I enzyme is conjugated to a targeting molecule, such as a cancer antigen, pathogen toxin or portion thereof, or a molecule that targets the glial scar; therefore, the cABC I enzymes delivered with the aid of a targeting molecule that has facile and specific localization to a physiological target(s) can be used in the methods of treatment provided (see Abstract; col. 12, lines 6-13; and entire document). Therefore, claims 1, 3-5, 9, 20, 26 and 39-40 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Prabhakar et al., (US 7,507,570). New-Claim Rejections: 35 USC § 103 Necessitated by claim amendments The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a). 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(a) 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. 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. Claims 1, 3-5, 8-9, 20-21, 26 and 39-40 are rejected under 35 U.S.C. 103(a) as being unpatentable over Prabhakar et al., (US 7,507,570) as applied to claims 1, 3-5, 9, 20, 26 and 39-40 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Hettiaratchi et al., (J. Controlled Release, 2019, Vol. 297: 14-25) and as evidenced by Paksula et al., (J. Controlled Release, 2013, Vol. 171: 11-26) and in view of UniProtKB/TrEMBL Accesion#A0A0G4Q5T7 disclose a chondroitinase ABC (ChABC) having 93.9% sequence identity to SEQ ID NO:1, having the following amino acid substitutions N300D, N321H, S437G and further comprising multiple substitutions corresponding to positions in SEQ ID NO: 1 of the instant application (see provided sequence alignments). Prabhakar et al., (US 7,507,570) are silent regarding wherein the binding peptide is a Src Homology 3 (SH3) domain (as in claim 21). Regarding claim 21, Hettiaratchi et al., (J. Controlled Release, 2019, Vol. 297: 14-25) and as evidenced by Paksula et al., (J. Controlled Release, 2013, Vol. 171: 11-26) disclosing the structure of chondroitinase ABC (ChABC) having 100% sequence identity to SEQ ID NO: 1 of the instant invention. Hettiaratchi et al., (J. Controlled Release, 2019, Vol. 297: 14-25) disclose fusion proteins comprising wild-type chondroitinase ABC (ChABC) and 3 different mutants of chondroitinase ABC (ChABC) with Src homology 3 (SH3) peptide fusions annotated as ChABC-SH3; N1000G-ChABC-SH3; Q140G-ChABC-SH3; T154F-ChABC-SH3; and S431L-ChABC-SH3 and the reference mutants having increased stability as compared to the wild-type chondroitinase ABC (ChABC; see Abstract; Results; and Fig. 2-3; Table 2, page 19; Fig. 5, page 21) and as pharmaceutical composition (see Abstract; Introduction; and entire document). Regarding claims 5 and 9, UniProtKB/TrEMBL Accesion#A0A0G4Q5T7 disclose a chondroitinase ABC (ChABC) having 93.9% sequence identity to SEQ ID NO:1, having the following amino acid substitutions N300D, N321H, S437G and further comprising multiple substitutions corresponding to positions in SEQ ID NO: 1 of the instant application (see provided sequence alignments). Therefore, it would have been obvious to a person of ordinary skill in the art to combine and modify the teachings of Prabhakar et al., generate fusion proteins comprising Src homology 3 (SH3) peptide fusions as suggested by Hettiaratchi et al., and employ the mutant chondroitinase ABC (ChABC) of UniProtKB/TrEMBL Accesion#A0A0G4Q5T7 disclose a chondroitinase ABC (ChABC) having 93.9% sequence identity to SEQ ID NO:1, having the following amino acid substitutions N300D, N321H, S437G and further comprising multiple substitutions corresponding to positions in SEQ ID NO: 1 of the instant application (see provided sequence alignments) and as pharmaceutical compositions; the expectation of success is high, because the combined teachings provide teaching, suggestion and motivation for fusion proteins comprising the mutant chondroitinase ABC (ChABC) and as pharmaceutical composition. Therefore, claims 1, 3-5, 8-9, 20-21, 26 and 39-40 are rejected under 35 U.S.C. 103(a) as being unpatentable over Prabhakar et al., (US 7,507,570) as applied to claims 1, 3-5, 9, 20, 26 and 39-40 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Hettiaratchi et al., (J. Controlled Release, 2019, Vol. 297: 14-25) and as evidenced by Paksula et al., (J. Controlled Release, 2013, Vol. 171: 11-26) and in view of UniProtKB/TrEMBL Accesion#A0A0G4Q5T7 disclose a chondroitinase ABC (ChABC) having 93.9% sequence identity to SEQ ID NO:1, having the following amino acid substitutions N300D, N321H, S437G and further comprising multiple substitutions corresponding to positions in SEQ ID NO: 1 of the instant application (see provided sequence alignments). Applicants’ have traversed the above 35 U.S.C. 103(a) rejection following claim amendments and said arguments are relevant to the new rejection (see page 17 of Applicants’ REMARKS dated 10/24/2025). Applicants’ argue: “…Nowhere in Fulton is there any disclosure of a mutant of ChABC having a melting temperature that is at least 4°C higher than the melting temperature of the wild-type ChABC or a functional half-life that is at least 4 times longer than that of the wild- type ChABC, as presently claimed. Thus, the combination of art cited fails to teach or suggest all of the features of claim 1 and claims dependent thereon. It is respectfully requested that this rejection be withdrawn.” Reply: Applicants’ arguments have been fully considered but are not deemed persuasive for the reasons stated in the Office-action dated 04/24/2025 and additionally for the following reasons: Examiner has provided a new reference; Prabhakar et al., (US 7,507,570) disclose wild-type chondroitinase ABC (ChABC) having 100% sequence identity to SEQ ID NO: 1 of the instant invention, homologs and variants of said having sequence identities of 99.1%, 93.1% to SEQ ID NO: 1 of the instant invention and variants comprising the following amino acid substitutions/point mutations, Q636G, Q665G, E694P, Q731G, Q736G, N738D, Q810G, Q814G as compared to SEQ ID NO: 1 of the instant invention (see provided sequence alignments); examiner takes the position that structure and function are inseparable and the variants disclosed by Prabhakar et al., (US 7,507,570) inherently possess al the claimed biochemical properties of the instant invention. Prabhakar et al., (US 7,507,570) also disclose fusion proteins of said chondroitinase ABC (ChABC) and pharmaceutical compositions; also provided herein are drug delivery strategies of cABC I and its modified counterparts; these include fusion proteins, where the cABC I enzyme is conjugated to a targeting molecule, such as a cancer antigen, pathogen toxin or portion thereof, or a molecule that targets the glial scar; therefore, the cABC I enzymes delivered with the aid of a targeting molecule that has facile and specific localization to a physiological target(s) can be used in the methods of treatment provided (see Abstract; col. 12, lines 6-13; and entire document). The combined teachings in the cited prior art provides a reasonable expectation of success and predictability for the claimed invention. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness. Summary of Pending Issues Claims 9-10 are objected to, due to the following informality: claims 9-10 depend from canceled claim 8. Upon further review of claims amendment; amended claim 3 and claims 4-5, 17 and 39-40 depending therefrom (dated 10/24/2025) are objected to under 35 U.S.C. 132(a), because it introduces new matter into the disclosure. Amended new claim 3 and claims 4-5, 17 and 39-40 depending therefrom (dated 10/24/2025) are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA )/new-matter, as failing to comply with the written description requirement. Claims 9-10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 1, 3-5, 9 and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception. Claims 1, 3-5, 9, 20, 26 and 39-40 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Prabhakar et al., (US 7,507,570). Claims 1, 3-5, 8-9, 20-21, 26 and 39-40 are rejected under 35 U.S.C. 103(a) as being unpatentable over Prabhakar et al., (US 7,507,570) as applied to claims 1, 3-5, 9, 20, 26 and 39-40 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Hettiaratchi et al., (J. Controlled Release, 2019, Vol. 297: 14-25) and as evidenced by Paksula et al., (J. Controlled Release, 2013, Vol. 171: 11-26) and in view of UniProtKB/TrEMBL Accesion#A0A0G4Q5T7 disclose a chondroitinase ABC (ChABC) having 93.9% sequence identity to SEQ ID NO:1, having the following amino acid substitutions N300D, N321H, S437G and further comprising multiple substitutions corresponding to positions in SEQ ID NO: 1 of the instant application (see provided sequence alignments). Non-elected combination of mutations in claim 10(a)-(c) and claims 6-7, 13-14, 22-25, 27-28, 30 and 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention. Conclusion None of the claims are allowable. Claims 1, 3-5, 9-10, 17, 20-21, 26 and 39-40 are objected/rejected for the reasons identified in the Rejections and Summary sections of this Office Action. Applicants must respond to the rejections in each of the sections in this Office Action to be fully responsive for prosecution. THIS ACTION IS MADE FINAL. 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 extension fee 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. Regarding filing an After Final amendment, Applicants are directed to MPEP 714.13, which states: II. ENTRY NOT A MATTER OF RIGHT It should be kept in mind that applicant cannot, as a matter of right, amend any finally rejected claims, add new claims after a final rejection (see 37 CFR 1.116) or reinstate previously canceled claims. Except where an amendment merely cancels claims, adopts examiner suggestions, removes issues for appeal, or in some other way requires ONLY A CURSORY REVIEW by the examiner (e.g., typographical errors), compliance with the requirement of a showing under 37 CFR 1.116(b)(3) is expected in all amendments after final rejection. An affidavit or other evidence filed after a final rejection, but before or on the same date of filing an appeal, may be entered upon a showing of good and sufficient reasons why the affidavit or other evidence is necessary and was not earlier presented in compliance with 37 CFR 1.116(e). See 37 CFR 41.33 and MPEP § 1206 for information on affidavit or other evidence filed after appeal. (Examiner's emphasis) If more than a cursory review is required, Applicants are referred to CFR §1.114. Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHIRAMA RAGHU whose telephone number is (571)272-4533. The examiner can normally be reached on M-F 8:30am-5pm EST. 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 on 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 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. /GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
Read full office action

Prosecution Timeline

Aug 09, 2022
Application Filed
Apr 21, 2025
Non-Final Rejection — §101, §102, §103
Oct 24, 2025
Response Filed
Nov 18, 2025
Final Rejection — §101, §102, §103 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12600960
Xylanase Variants
2y 5m to grant Granted Apr 14, 2026
Patent 12595471
AMYLASE VARIANTS
2y 5m to grant Granted Apr 07, 2026
Patent 12594307
COMPOSITIONS AND METHODS OF USING INDUCIBLE SIGNALING FOR TUNABLE DYNAMICS IN MICROBIAL COMMUNITIES
2y 5m to grant Granted Apr 07, 2026
Patent 12595440
2709 ALKALI PROTEASE MUTANT MODIFIED BASED ON MOLECULAR DYNAMICS CALCULATION AND USE THEREOF
2y 5m to grant Granted Apr 07, 2026
Patent 12595499
PROTEIN HAVING 1,3-FUCOSYLTRANSFERASE ACTIVITY, AND METHOD FOR PRODUCING FUCOSE-CONTAINING SUGAR
2y 5m to grant Granted Apr 07, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

3-4
Expected OA Rounds
74%
Grant Probability
99%
With Interview (+26.3%)
2y 8m
Median Time to Grant
Moderate
PTA Risk
Based on 1285 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month