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 .
Status of the Claims
The claims filed 11/28/2023 are acknowledged. No amendment to this claim set has been filed. Claims 1-17 are under examination.
Effective Filing Date
Applicant’s claims for the benefit of a prior-filed application under 35 U.S.C. 120 and 121 and foreign priority are acknowledged. Under the AIA , the effective filing date of a claimed invention is the earlier of:
The actual filing date of the application;
OR
The filing date to which the application is entitled to a right of foreign priority or domestic benefit as to such claimed invention.
Based on the information given by Applicant and an inspection of the prior patents and applications, the Examiner has concluded that the subject matter defined in the instant claims is supported by the disclosures in application serial nos. 16,002,058 (now US Patent 10,793,634) and 17/002,907 (now US Patent 11,866,501). Note that with regard to claiming foreign priority, the foreign priority date is the effective filing date of the claimed invention IF
the foreign application supports the claimed invention under 112(a), AND
the applicant has perfected the right of priority by providing:
a certified copy of the priority application, and
a translation of the priority application (if not in English).
While the certified copy of the foreign priority application is in English, it does not appear to support the claimed invention under 112(a) because it does not disclose treating hearing loss. Therefore, the effective filing date of the instant application is 06/07/2018.
Claim Rejections - 35 USC § 112(d)
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 3-8 are 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 3-8 ultimately depend from claim 1, which recites treatment of hearing loss with anti-TrkB antibodies. Claim 1 groups the antibodies into three alternative embodiments in which:
I(a)-I(d) represent antibodies defined by the recited light and heavy chain complementarity determining regions (CDRs);
II(a)-II(i) represent antibodies defined by the recited variable light and variable heavy chains, and
III(a)-III(i) represent antibodies defined by the recited full light and heavy chains.
The antibodies defined by the CDRs (I(a)-I(d)) are the broadest in scope, those represented by the variable chains (II(a)-II(i)) are more specific and those represented by the full light and heavy chains (III(a)-(III(i)) are the most specific. Claim 3 depends from claim 1, and recites the antibodies set forth in the first embodiment, however, insomuch as claim 1 encompasses either of the two narrower embodiments, claim 3 is broader in scope. Similarly, claim 5 depends from claim 1 and recites the antibodies set forth in the second embodiment, and insomuch as claim 1 encompasses the narrowest embodiment of antibodies defined by their full light and heavy chains, claim 5 does not further limit claim 1. Further, claim 7 depends from claim 1 and recites the antibodies set forth in the narrowest embodiment, but insomuch as claim 1 encompasses the narrowest embodiment, claim 7 does not further limit claim 1 as it merely repeats the same limitation. This issue is also present in claims 3 and 5. Finally, claims 4, 6 and 8, which depend from claims 3, 5 and 7, respectively, are hereby included in this rejection.
Applicant may cancel the claims, amend the claims to place them in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 21-38 of U.S. Patent No. 10,793,634 in view of Sarogovi et al. (US 20170029511; published 02/02/2017). The ‘634 patent was filed as application serial no. 16/002,058 and is the parent of application serial no. 17/002,907 (now US Patent 11,866,501), which was filed as a divisional, however, the instant application was filed as a continuation, thus, the 121 shield does not apply.
The claims of the ‘634 patent are drawn to the same anti-TrkB antibodies encompassed by the instant claims. The ‘634 claims are silent with respect to treating hearing loss with the claimed anti-TrkB antibodies. Nevertheless, Saragovi et al. disclose treating hearing loss with TrkB agonist antibodies (see claims 1-25). When read in light of the PGPUB by Sargovi et al., it would have been obvious to the person having ordinary skill in the art that the anti-TrkB antibodies of the ‘634 patent, which are also agonist antibodies, could be used in methods of treating hearing loss.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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, Jeffrey Stucker can be reached at 5712720911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675