DETAILED ACTION
Status of the Application
Claims 1-4, 6-19 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment of claim 1 as submitted in a communication filed on 12/19/2025 is acknowledged.
Applicant elected without traverse Group I, claim 1, drawn in part to a variant of the protein of SEQ ID NO: 30, and the combination of substitutions M14I, Y31W, T69P, T77I, T98I, S136A, E222D, G224S, A232S, N236T, Y288V and G297K, in a communication filed on 9/12/2025 is acknowledged.
Claims 2-4, 6-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 9/12/2025. Claim 1 is at issue and is being examined herein.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
Claim 1 remains rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. New grounds of rejection are necessitated by amendment.
Claim 1 is indefinite in the recitation of “…polypeptide comprising a sequence of: (i) SEQ ID NO: 30 having an M14I substitution…and a mutation selected from the group consisting of…; (ii) SEQ ID NO: 30 having an M14I substitution …..and a mutation selected from the group consisting of….and (iii) a polypeptide sequence that is at least 85% identical to SEQ ID NO: 30 having an M14I substitution…” for the following reasons. As written, it is unclear as to how the recombinant polypeptide can have the three amino acid sequences listed in (i), (ii) and (iii). Please note that the claims recite “…comprising a sequence of (i)….(ii) ….and (iii)…. “. For examination purposes, it will be assumed that the claim recites “…comprising a sequence of (i)….(ii) ….or (iii)…. “. Correction is required.
Claim 1 is indefinite in the recitation of “(i) SEQ ID NO: 30 having an M14I substitution, a Y31W substitution, a T98I substitution….and a mutation selected from the group consisting of T69P, T77I, and a combination thereof…polypeptide sequence that is at least 85% identical to SEQ ID NO: 30 having an M14I substitution, …and a mutation selected from the group consisting of T69P, T77I and a combination thereof” for the following reasons. The recitation of numerical positions with regard to substitutions is meaningless in the absence of the specific sequence identifier associated with those positions. If the intended sequence identifier is SEQ ID NO: 30 , the claim should be amended accordingly. In addition, the term “and a combination thereof” is unclear and confusing because one cannot determine if the term “thereof” refers solely to the substitutions T69P and T77I, or if the term “thereof” refers to M14I, Y31W, T98I, S163A, E222D, G224S, A232S, N236T, Y288X, T69P and T77I. In addition, as written, it is unclear if the sequences of items (i) and (ii) are sequences that comprise all of SEQ ID NO: 30 except for the recited substitutions, or if the sequences of item (i) and (ii) are variants of SEQ ID NO: 30 which comprise the recited substitutions and can comprise additional modifications compared to SEQ ID NO: 30. For examination purposes, it will be assumed that claim 1 is directed to a polypeptide that comprises (i) an amino acid sequence which is a variant of SEQ ID NO: 30 that comprises substitutions that correspond to substitutions M14I, Y31W, T98I, S163A, E222D, G224S, A232S, N236T, and Y288X in the polypeptide of SEQ ID NO: 30, wherein X is A, N, S, V or a non-natural amino acid, and wherein the amino acid sequence further comprises one or more substitutions that correspond to substitutions T69P and T77I of the polypeptide of SEQ ID NO: 30, (ii) an amino acid sequence which is a variant of SEQ ID NO: 30 that comprises substitutions that correspond to substitutions M14I, Y31W, T98I, S163A, E222D, G224S, A232S, N236T, and Y288X in the polypeptide of SEQ ID NO: 30, wherein X is A, N, S, V or a non-natural amino acid, wherein the amino acid sequence further comprises one or more substitutions that correspond to substitutions T69P and T77I of the polypeptide of SEQ ID NO: 30, and wherein the amino acid sequence also comprises from 1 to 20 additional substitutions which are conservative substitutions, or (iii) an amino acid sequence which is at least 85% identical to SEQ ID NO: 30, wherein said amino acid sequence comprises substitutions that correspond to substitutions M14I, Y31W, T98I, S163A, E222D, G224S, A232S, N236T, and Y288X in the polypeptide of SEQ ID NO: 30, wherein X is A, N, S, V or a non-natural amino acid, and wherein the amino acid sequence further comprises one or more substitutions that correspond to substitutions T69P and T77I of the polypeptide of SEQ ID NO: 30, wherein the polypeptide may or may not have aromatic prenyltransferase activity. Correction is required.
When amending the claims, applicant is advised to carefully review all examined claims and make the necessary changes to ensure proper antecedent basis and dependency.
Claim Rejections - 35 USC § 112(a) or First Paragraph (pre-AIA )
Claim 1 remains 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection has been discussed at length in the prior Office action. It is maintained for the reasons of record and those set forth below.
Applicant argues that the claimed invention is described throughout the specification as filed. Applicant submits that the claim is directed to a sequence of SEQ ID NO: 30 that recites selected amino acid substitutions in the sequence and has prenyltransferase activity. Applicant is of the opinion that the claimed subject matter does not go beyond the disclosure of the specification.
Applicant’s arguments have been fully considered but not deemed persuasive to overcome the instant rejection. The Examiner acknowledges the amendments made to the claim. However, the Examiner disagrees with Applicant’s contention that the specification adequately describes the entire genus of proteins encompassed by the claim. Contrary to Applicant’s assertions, the polypeptides of the claim are not all required to have enzymatic activity. Please note that claim 1 reads “wherein the polypeptide of (i), (ii) or (iii) has aromatic prenyltransferase activity”. As such, only one and not all of the polypeptides in claim 1 is required to have aromatic prenyltransferase activity. In addition, as indicated above, the polypeptides of claim 1, parts (i) and (ii) do not appear to be limited to variants of the polypeptide of SEQ ID NO: 30 that comprise all of SEQ ID NO: 30 except for the recited substitutions. See Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA ) for claim interpretation. Therefore, the polypeptide of (i) and (ii) can have any structure so long as they have the recited substitutions.
The claims encompass a large genus of proteins which are structurally unrelated or substantially unrelated. A polypeptide having at least 85% sequence identity with the polypeptide of SEQ ID NO: 30 allows for any combination of 47 amino acid modifications within SEQ ID NO: 30 (47 = 0.15x307; SEQ ID NO: 30 has 307 amino acids). The total number of variants of a polypeptide having a specific number of amino acid substitutions can be calculated from the formula N!x19A/(N-A)!/A!, where N is the length in amino acids of the reference polypeptide and A is the number of allowed substitutions. Thus, the total number of variants of the protein of SEQ ID NO: 30 that have at least 85% sequence identity to the polypeptide of SEQ ID NO: 30 that result from amino acid substitutions is 307!x1947/(307-47)!/47! or 9.36x10115 variants.
It is reiterated herein that while the specification in the instant application discloses the structure of a limited number of species of the genus of variants of the polypeptide of SEQ ID NO: 30 having the recited substitutions, it provides no clue as to the structural elements required in any protein having aromatic prenyltransferase activity, nor does it teach which structural elements within the polypeptide of SEQ ID NO: 30 are required in any protein having aromatic prenyltransferase activity. No disclosure of a structure/function correlation has been provided which would allow one of skill in the art to recognize which structural variants of the polypeptide of SEQ ID NO: 30 having the recited structural limitations have aromatic prenyltransferase activity, specifically the ability to catalyze the conversion of olivetolic acid or divarinic acid to cannabigerolic acid or cannabigerovarinic acid, respectively. Furthermore, while one could argue that the few species disclosed are representative of the structure of all the members of the genus, it is noted that the art teaches several examples of how even highly structurally homologous polypeptides can have different enzymatic activities. See the teachings of Witkowski et al., Seffernick et al. and Tang et al. previously discussed. Therefore, contrary to Applicant’s assertions, the entire genus of polypeptides claimed is not adequately described by the teachings of the specification and/or the prior art.
Claim 1 remains rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a protein that has aromatic prenyltransferase activity and comprises all of SEQ ID NO: 30 except for (a) substitutions that correspond to the substitutions M14I, Y31W, T98I, S163A, E222D, G224S, A232S, N236T, and Y288X in the polypeptide of SEQ ID NO: 30, wherein X is A, N, S, V or a non-natural amino acid, and (b) one or more substitutions that correspond to substitutions in the polypeptide of SEQ ID NO: 30 selected from T69P and T77I, does not reasonably provide enablement for a variant of the polypeptide of SEQ ID NO: 30 that comprises (i) substitutions that correspond to the substitutions M14I, Y31W, T98I, S163A, E222D, G224S, A232S, N236T, and Y288X in the polypeptide of SEQ ID NO: 30, wherein X is A, N, S, V or a non-natural amino acid, and (ii) one or more substitutions that correspond to substitutions in the polypeptide of SEQ ID NO: 30 selected from T69P and T77I, wherein said variant may or may not have aromatic prenyltransferase activity. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
This rejection has been discussed at length in the prior Office action. It is maintained for the reasons of record and those set forth below.
Applicant argues that the claim is not directed to any structure but rather the structure of SEQ ID NO: 30 with the specifically recited substitutions and which has aromatic prenyltransferase activity. Applicant states that the specification makes clear that the polypeptides recited in claim 1 do have biological activity.
Applicant’s arguments have been fully considered but not deemed persuasive to overcome the instant rejection. The Examiner acknowledges the amendments made to the claim. However, the Examiner disagrees with Applicant’s contention that the specification fully enables the entire scope of the claim.
It is reiterated herein that the polypeptides of the claim are not all required to have enzymatic activity because claim 1 reads “wherein the polypeptide of (i), (ii) or (iii) has aromatic prenyltransferase activity”. As such, only one and not all of the polypeptides in claim 1 is required to have aromatic prenyltransferase activity. In addition, as indicated above, the polypeptides of claim 1, parts (i) and (ii) do not appear to be limited to variants of the polypeptide of SEQ ID NO: 30 that comprise all of SEQ ID NO: 30 except for the recited substitutions. See Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA ) for claim interpretation. Therefore, the polypeptide of (i) and (ii) can have any structure so long as they have the recited substitutions.
It is reiterated herein that while the specification in the instant application discloses the structure of a limited number of species of the genus of variants of the polypeptide of SEQ ID NO: 30 having the recited substitutions, it provides no clue as to the structural elements required in any protein having aromatic prenyltransferase activity, nor does it teach which structural elements within the polypeptide of SEQ ID NO: 30 are required in any protein having aromatic prenyltransferase activity. No disclosure of a structure/function correlation has been provided which would allow one of skill in the art to recognize which structural variants of the polypeptide of SEQ ID NO: 30 having the recited structural limitations have aromatic prenyltransferase activity, specifically the ability to catalyze the conversion of olivetolic acid or divarinic acid to cannabigerolic acid or cannabigerovarinic acid, respectively. In addition, the art does not provide any teaching or guidance as to which changes can be made to the protein of SEQ ID NO: 30 such that the resulting variant would display the desired functional characteristics, or the general tolerance of aromatic prenyltransferases to structural modifications and the extent of such tolerance. The art clearly teaches that (a) determining function based solely on structural homology, and (b) modification of a protein’s amino acid sequence to obtain the desired activity without any guidance/knowledge as to which amino acids in a protein are tolerant of modification and which ones are conserved are highly unpredictable. See the teachings of Singh et al. and Sadowski et al. previously discussed. In the absence of (i) a rational and predictable scheme for selecting those proteins most likely to have the desired functional features, and/or (ii) a correlation between structure and metalloprotease activity, one of skill in the art would have to test an essentially infinite number of proteins to determine which ones have the desired functional characteristics. This is not deemed routine experimentation. Thus, for the reasons of record and those set forth above one cannot reasonably conclude that the entire scope of the claim is fully enabled by the teachings of the specification and/or the prior art.
Claim Rejections - 35 USC § 102 (AIA )
Claim 1 was rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mendez et al. (WO 2019/183152 published 9/26/2019; cited in the IDS).
In view of the fact that claim 1 requires a polypeptide that comprises substitutions that correspond to the substitutions M14I, Y31W, T98I, S163A, E222D, G224S, A232S, N236T, and Y288X in the polypeptide of SEQ ID NO: 30, wherein X is A, N, S, V or a non-natural amino acid, wherein the polypeptide further comprises one or more substitutions that correspond to substitutions in the polypeptide of SEQ ID NO: 30 selected from T69P and T77I, and the fact that Mendez et al. do not teach substitutions that correspond to the substitutions M14I, Y31W, T98I, S163A, E222D, G224S, N236T, T69P or T77I of the polypeptide of SEQ ID NO: 30, this rejection is hereby withdrawn.
Double Patenting
Claim 1 remains rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over (i) claim 5 of U.S. Patent No. 11,518,983, and (ii) claim 5 of U.S. Patent No. 12,084,689.
This rejection has been discussed at length in the prior Office action. It is maintained for the reasons of record and those set forth below.
Applicant argues that the ’983 and ’689 patents are not prior art. Applicant cites Ex Parte Baurin Appeal 2024-002920 in support of the argument that these patents are not proper ODP reference patents. Applicant states that (i) the earlier filed earlier expiring application is not a second later expiring patent for the same invention, (ii) the Office did not make an ODP rejection in the later filed, later expiring unrelated patent over the earlier filed, earlier expiring unrelated patent, and (iii) the subject matter of the claims in the later filed, later expiring patent could not have been presented in the claim of the earlier filed, earlier expiring unrelated patent.
Applicant’s arguments have been fully considered but not deemed persuasive to overcome the instant rejection. The Examiner acknowledges that (i) U.S. Patent No. 11,518,983 was issued from application No. 17/824,118, which was filed on 5/25/2022, (ii) U.S. Patent No. 12,084,689 issued from application No. 17/934,560, which was filed on 9/22/2022 and is a continuation of application No. 17/824,118, which was filed on 5/25/2022, and (iii) the instant application is the US national application which entered the national stage from PCT/US2020/067032 filed on 12/24/2020 and was published as U.S. Publication No. 2023/0348866 on 11/2/2023, after the filing date of both 17/824,118 and 17/934,560. However, the Examiner disagrees with Applicant’s contention that U.S. Patent No. 11,518,983 and 12,084,689 are improper ODP reference patents. The Examiner acknowledges the decision in Ex Parte Baurin. However, it is noted that (i) the Examiner cannot determine at this time the expiration date of any patent issued from the instant application because patent term can be extended or adjusted, (ii) it would be improper for the Examiner to make comments regarding the prosecution of applications No. 17/824,118 and 17/934,560, and ODP rejections in those applications, (iii) there is no prohibition in the MPEP for making double patenting rejections over patents or applications that have a later filing date, and (iv) the instant case is not the same as that discussed in Ex Parte Baurin.
Applicant is reminded that the Examiner has not argued that the inventions of claim 5 of U.S. Patent No. 11,518,983 and claim 5 of U.S. Patent No. 12,084,689 are obvious over the invention of claim 1 of the instant application. Instead, the Examiner has indicated that the inventions of claim 5 of U.S. Patent No. 11,518,983 and claim 5 of U.S. Patent No. 12,084,689 anticipate the invention of claim 1. Claim 1 of the instant application is directed in part to a variant of the polypeptide of SEQ ID NO: 30 having any structure, or at least 85% sequence identity to the polypeptide of SEQ ID NO: 30, wherein said variant comprises (a) substitutions that correspond to the substitutions M14I, Y31W, T98I, S163A, E222D, G224S, A232S, N236T, and Y288X in the polypeptide of SEQ ID NO: 30, wherein X is A, N, S, V or a non-natural amino acid, and (b) one or more substitutions that correspond to substitutions in the polypeptide of SEQ ID NO: 30 selected from T69P and T77I, wherein said variant can optionally comprise 1-20 additional conservative substitutions, and wherein said variant may or may not have aromatic prenyltransferase activity. See Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA ) for claim interpretation.
Claim 5 of U.S. Patent No. 11,518,983 is directed in part to a recombinant polypeptide having prenyltransferase activity which is at least 90% sequence identical to the polypeptide of SEQ ID NO: 4, wherein said polypeptide comprises substitutions corresponding to substitutions A232S and Y288V of the polypeptide of SEQ ID NO: 4, as well as substitutions corresponding to substitutions M14I, Y31W, T69P, T77I, T98I, S136A, E222D, G224S, N236T, L33I and S277T in the polypeptide of SEQ ID NO: 4. The polypeptide of SEQ ID NO: 4 of U.S. Patent No. 11,518,983 is identical to the protein of SEQ ID NO: 30 of the instant application except for two substitutions, A232S and Y288V. See alignment below. The substitutions L33I and S277T are conservative substitutions. Therefore, the recombinant polypeptide of claim 5 that comprises the substitutions corresponding to substitutions M14I, Y31W, T69P, T77I, T98I, S136A, E222D, G224S, N236T, L33I and S277T in the polypeptide of SEQ ID NO: 4 is a variant of the polypeptide of SEQ ID NO: 30 that comprises the substitutions that correspond to substitutions A232S, Y288V, M14I, Y31W, T69P, T77I, T98I, S136A, E222D, G224S, and N236T as well as two additional conservative substitutions (L33I and S277T). As such, the variant of claim 1 of the instant application is anticipated by the polypeptide of claim 5 of U.S. Patent No. 11,518,983.
Claim 5 of U.S. Patent No. 12,084,689 is directed in part to a recombinant polypeptide having prenyltransferase activity which is at least 85% sequence identity to the polypeptide of SEQ ID NO: 4, wherein said polypeptide comprises substitutions corresponding to substitutions A232S and Y288V of the polypeptide of SEQ ID NO: 4, as well as substitutions corresponding to substitutions M14I, Y31W, T69P, T77I, T98I, S136A, E222D, G224S, N236T, L33I and S277T in the polypeptide of SEQ ID NO: 4. The polypeptide of SEQ ID NO: 4 of U.S. Patent No. 12,084,689 is identical to the protein of SEQ ID NO: 30 of the instant application except for two substitutions, A232S and Y288V. See alignment below. The substitutions L33I and S277T are conservative substitutions. Therefore, the recombinant polypeptide of claim 5 that comprises the substitutions corresponding to substitutions M14I, Y31W, T69P, T77I, T98I, S136A, E222D, G224S, N236T, L33I and S277T in the polypeptide of SEQ ID NO: 4 is a variant of the polypeptide of SEQ ID NO: 30 that comprises the substitutions that correspond to substitutions A232S, Y288V, M14I, Y31W, T69P, T77I, T98I, S136A, E222D, G224S, and N236T as well as two additional conservative substitutions (L33I and S277T). As such, the variant of claim 1 of the instant application is anticipated by the polypeptide of claim 5 of U.S. Patent No. 12,084,689.
Therefore, for the reasons of record and those set forth above, these patents are deemed proper ODP reference patents.
SEQ ID NO:30
US-17-934-560-4
Filing date in PALM: 2022-09-22
Sequence 4, US/17934560
Patent No. 12084689
GENERAL INFORMATION
APPLICANT: Invizyne Technologies, Inc. (en)
TITLE OF INVENTION: PRENYLTRANSFERASE VARIANTS WITH INCREASED THERMOSTABILITY (en)
FILE REFERENCE: 15041.002WO1
CURRENT APPLICATION NUMBER: US/17/934,560
CURRENT FILING DATE: 2022-09-22
NUMBER OF SEQ ID NOS: 58
SEQ ID NO 4
LENGTH: 307
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..307
QUALIFIERS: note = Synthetic polypeptide
FEATURE:
NAME/KEY: source
LOCATION: 1..307
QUALIFIERS: mol_type = protein
organism = synthetic construct
ALIGNMENT:
Query Match 99.3%; Score 1573; Length 307;
Best Local Similarity 99.3%;
Matches 305; Conservative 1; Mismatches 1; Indels 0; Gaps 0;
Qy 1 MSEAADVERVYAAMEEAAGLLGVACARDKIYPLLSTFQDTLVEGGSVVVFSMASGRHSTE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSEAADVERVYAAMEEAAGLLGVACARDKIYPLLSTFQDTLVEGGSVVVFSMASGRHSTE 60
Qy 61 LDFSISVPTSHGDPYATVVEKGLFPATGHPVDDLLADTQKHLPVSMFAIDGEVTGGFKKT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 LDFSISVPTSHGDPYATVVEKGLFPATGHPVDDLLADTQKHLPVSMFAIDGEVTGGFKKT 120
Qy 121 YAFFPTDNMPGVAELSAIPSMPPAVAENAELFARYGLDKVQMTSMDYKKRQVNLYFSELS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 YAFFPTDNMPGVAELSAIPSMPPAVAENAELFARYGLDKVQMTSMDYKKRQVNLYFSELS 180
Qy 181 AQTLEAESVLALVRELGLHVPNELGLKFCKRSFSVYPTLNWETGKIDRLCFAVISNDPTL 240
|||||||||||||||||||||||||||||||||||||||||||||||||||:||||||||
Db 181 AQTLEAESVLALVRELGLHVPNELGLKFCKRSFSVYPTLNWETGKIDRLCFSVISNDPTL 240
Qy 241 VPSSDEGDIEKFHNYATKAPYAYVGEKRTLVYGLTLSPKEEYYKLGAYYHITDVQRGLLK 300
||||||||||||||||||||||||||||||||||||||||||||||| ||||||||||||
Db 241 VPSSDEGDIEKFHNYATKAPYAYVGEKRTLVYGLTLSPKEEYYKLGAVYHITDVQRGLLK 300
Qy 301 AFDSLED 307
|||||||
Db 301 AFDSLED 307
SEQ ID NO:30
RESULT 162
US-17-824-118-4
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 4, US/17824118
Patent No. 11518983
GENERAL INFORMATION
APPLICANT: Invizyne Technologies, Inc.
APPLICANT: KORMAN, Tyler P.
TITLE OF INVENTION: PRENYLTRANSFERASE VARIANTS WITH INCREASED THERMOSTABILITY
FILE REFERENCE: 15041.002WO1
CURRENT APPLICATION NUMBER: US/17/824,118
CURRENT FILING DATE: 2022-05-25
PRIOR APPLICATION NUMBER: US 63/193,221
PRIOR FILING DATE: 2021-05-26
NUMBER OF SEQ ID NOS: 58
SEQ ID NO 4
LENGTH: 307
TYPE: PRT
ORGANISM: artificial
FEATURE:
OTHER INFORMATION: Synthetic polypeptide
Query Match 99.3%; Score 1573; Length 307;
Best Local Similarity 99.3%;
Matches 305; Conservative 1; Mismatches 1; Indels 0; Gaps 0;
Qy 1 MSEAADVERVYAAMEEAAGLLGVACARDKIYPLLSTFQDTLVEGGSVVVFSMASGRHSTE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSEAADVERVYAAMEEAAGLLGVACARDKIYPLLSTFQDTLVEGGSVVVFSMASGRHSTE 60
Qy 61 LDFSISVPTSHGDPYATVVEKGLFPATGHPVDDLLADTQKHLPVSMFAIDGEVTGGFKKT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 LDFSISVPTSHGDPYATVVEKGLFPATGHPVDDLLADTQKHLPVSMFAIDGEVTGGFKKT 120
Qy 121 YAFFPTDNMPGVAELSAIPSMPPAVAENAELFARYGLDKVQMTSMDYKKRQVNLYFSELS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 YAFFPTDNMPGVAELSAIPSMPPAVAENAELFARYGLDKVQMTSMDYKKRQVNLYFSELS 180
Qy 181 AQTLEAESVLALVRELGLHVPNELGLKFCKRSFSVYPTLNWETGKIDRLCFAVISNDPTL 240
|||||||||||||||||||||||||||||||||||||||||||||||||||:||||||||
Db 181 AQTLEAESVLALVRELGLHVPNELGLKFCKRSFSVYPTLNWETGKIDRLCFSVISNDPTL 240
Qy 241 VPSSDEGDIEKFHNYATKAPYAYVGEKRTLVYGLTLSPKEEYYKLGAYYHITDVQRGLLK 300
||||||||||||||||||||||||||||||||||||||||||||||| ||||||||||||
Db 241 VPSSDEGDIEKFHNYATKAPYAYVGEKRTLVYGLTLSPKEEYYKLGAVYHITDVQRGLLK 300
Qy 301 AFDSLED 307
|||||||
Db 301 AFDSLED 307
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.
Conclusion
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 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 date of this final action.
Applicant is advised that any Internet email communication by the Examiner has to be authorized by Applicant in written form. See MPEP § 502.03 (II). Without a written authorization by Applicant in place, the USPTO will not respond via Internet email to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Sample written authorization language can be found in MPEP § 502.03 (II). An Authorization for Internet Communications in a Patent Application or Request to Withdraw Authorization for Internet Communications form (SB/439) can be found at https://www.uspto.gov/patent/forms/ forms-patent-applications-filed-or-after-september-16-2012, which can be electronically filed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DELIA M RAMIREZ, Ph.D., whose telephone number is (571) 272-0938. The examiner can normally be reached on Monday-Friday from 8:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert B. Mondesi, can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/DELIA M RAMIREZ/Primary Examiner, Art Unit 1652
DR
January 13, 2026