DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 4/7/26 has been entered in full. Claims 1, 4 and 10 are amended. New claims 30-34 are added. Claims 1-10, 18 and 30-34 are pending.
Information Disclosure Statement
The Information Disclosure Statement of 4/7/26 has been considered.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (1/9/26).
The objection to the specification at page 2 is withdrawn in view of the amendments to the title.
The objections to claims 4 and 10 at pages 2-3 are withdrawn in view of the amendments to the claims.
The rejection of claims 1-10 and 18 at pages 3-8 under 35 U.S.C. 112(a) for failing to comply with the written description requirement is withdrawn in view of the amendments to the claims.
Duplicate claims, Warning
Applicant is advised that should claim 5 be found allowable, new claim 31 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
Specifically, claim 5 limits the isolated antibody or antigen-binding fragment thereof of claim 4 to one comprising a HCVR/LCVR amino acid sequence pair having at least 95% sequence identity to SEQ ID NOs: 2/10. New claim 31 depends limits claim 30 in the same manner. However, both claims ultimately depend from independent claim 1, and the limitations of claims 5 and 31 result in an antibody or antigen-binding fragment of the same scope: comprising a HCVR/LCVR amino acid sequence pair having at least 95% sequence identity to SEQ ID NOs: 2/10. As such, the claims are substantial duplicates.
Maintained Objections and/or Rejections
Double Patenting
The nonstatutory double (NSDP) 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 NSDP 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 (TD) in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on NSDP 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 TD must be signed in compliance with 37 CFR 1.321(b).
The filing of a TD by itself is not a complete reply to a NSDP rejection. A complete reply requires that the TD 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 TD 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 (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10, 18 and 30-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,306,148, issued 4/19/22 (cited on the 9/4/24 IDS), and which shares the same applicant and inventors with the instant application.
This rejection was set forth previously at pages 9-11 of the 1/9/26 Office action for claims 1-10 and 18; Applicants addition of claims 30-34 necessitates addition of these claims to the rejection.
Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The instant application claims priority as a continuation to application 18/485,241 (now abandoned), which in in turn claims priority as a continuation to application 17/692,084, which in turn claims priority as a continuation to application 16/657,000, which issued as the ‘148 patent.
As amended, independent claim 1 encompasses an isolated antibody or antigen-binding fragment that binds specifically to natriuretic peptide receptor 1 (NPR1) protein, wherein the antibody comprises HCDR1-3 contained with a heavy chain variable region (HCVR) comprising an amino acid sequence having no more than three amino acid substitutions relative to SEQ ID NO: 2, and comprises LCDR1-3 contained within a light chain variable region (LCVR) comprising an amino acid sequence having no more than three amino acid substitutions relative to SEQ ID NO: 10. Claim 1 of ‘148 is directed to an antibody or antigen-binding fragment that specifically binds to NPR1 and comprises the HCDR1-3 of SEQ ID NO: 2 and the LCDR1-3 of SEQ ID NO: 10. As such, instant claim 1 as amended still fully encompasses the claim 1 of ‘148, and as such the claims ‘148 anticipate the instant claims, and the two sets of claims are therefore not patentably distinct.
Instant claims 2-10, 18, and 30-31 depend from claim 1 and each further limit the method of claim 1 embodiments that correspond to the further limitations of the antibody of the dependent claims of ‘148 in the following manner:
Instant Claim
Claim of ‘148
2
2
3
3
4
4
5
5
6
6
7
7
8
8
9
9
10
10
18
11
30
4
31
5
As such, the antibody or antigen-binding fragment of instant dependent claims 2-10 and 30-31, and the composition of instant dependent claim 18, are anticipated by the corresponding claims of the ‘148 patent, and as such these instant claims are also not patentably distinct from the claims of ‘148.
New claims 32-34 each depend from claim 1 and limits the antibody to one wherein the three conservative substitutions in each of the heavy and light chain variable regions are outside the CDRs (claim 32), or wherein each of the substitutions is a conservative substitution (claim 33), or wherein each of the substitutions is outside the CDR regions (claim 34). The anti-NPR1 antibody of claim 1 of ‘148 is limited to comprising the HCDRs of SEQ ID NO: 2 and the LCDRs of SEQ ID NO: 10, but broadly encompasses other mutations outside the CDRs. While the claims of ‘148 does not expressly recite that the antibody has conservative substitutions outside these CDR regions, the portion of the specification informing the claimed invention does envision such subject matter as part of the claimed invention (see col 16, lines 12-63). Thus, the scope of claim 1 of ‘148 is properly construed as encompassing such subject matter. As such, new claims 32-34 are also not patentably distinct from the claims of ‘148.
In reply to the rejection, Applicants asks to “hold this rejection until all the other remaining rejections and/or objections are overcome” (pages 8-9).
Applicants’ request is noted, but per MPEP 804, “[a] complete response to a nonstatutory [DP] rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action.” As Applicants have not provided either a showing that the rejected claims are patentably distinct from the claims of the ‘148 application, or a terminal disclaimer, the rejection is maintained.
New objections
Claim Objections
Claims 1-10, 18 and 30-34 are objected to for the following informalities:
In claim 1, the two newly added wherein clauses should be joined by the conjunction “and”, i.e., “…HCDR, and wherein only…”
In claim 3, line 2, “sequence identify” should be “sequence identity”.
In claim 5, line 2, “sequence identify” should be “sequence identity”.
In claim 31, line 2, “sequence identify” should be “sequence identity”.
In each of claims 33 and 34, lines 1-2, “amino substitutions” should be “amino acid substitutions”.
In each of claims 33 and 34, line 2, the verb “is” should be used with the single subject “each”; i.e., “wherein each of the amino acid substitutions is a conservative amino acid substitution” (claim 32) and “wherein each of the amino acid substitutions is outside of the CDR regions”.
The remaining claims are objected to for depending from an objected claim.
Appropriate correction is required.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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