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 .
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.
DETAILED ACTION
This action is in response to claim amendments filed 3/26/24. Claims 2-12 are pending and under examination.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 2 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 15 of prior U.S. Patent No. 11732034. This is a statutory double patenting rejection.
Reference claim 15 is a composition, as is instant claim 2. Both claims comprise a carrier. Reference claim 15 recites the conjugated antibody of claim 1. The antibody of reference claim 1 and instant claim 2 are verbatim identical with respect to the monoclonal Tau-binding antibody, including the CDR sequences and conjugation to the effector/label. Reference claim 15, written in independent form, is co-extensive in scope with instant claim 2.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 10287343 in view of Novak (US20150050215; form 892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 2, the reference claims are directed to antibodies comprising the same CDRs as found in, e.g., instant claim 2. The difference is that the reference claims are not conjugated to an effector or detectable label nor do the reference claims include a carrier. Novak also teaches anti-tau antibodies (claim 1). Novak teaches including these tau antibodies in conjugation with a carrier (claim 34) and a detectable label (claim 37). Novak and the reference claims also claim methods of detecting the antibody by contacting the antibody with a sample. It would have been obvious to one of ordinary skill in the art at the time of filing to include a carrier and to conjugate the antibody with a detectable label to obtain the same benefits as in the reference claims and in Novak, e.g., administering the antibody (carrier) to detect the antibody (conjugation to a detectable label).
Regarding claims 3-5 and 7-12, the reference document claims the same sequences for the heavy and light chains (claims 2-4).
Regarding claim 6, the reference document claims the antibody is a monoclonal humanized antibody (claim 5).
Claims 2 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10889640 in view of Novak (US20150050215). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 2, the reference claims are directed to antibodies comprising SEQ ID NOs: 7 and 8, which comprise the same CDRs as found in, e.g., instant claim 2. The difference is that the reference claims are not conjugated to an effector or detectable label nor do the reference claims include a carrier. Novak also teaches anti-tau antibodies (claim 1). Novak teaches including these tau antibodies in conjugation with a carrier (claim 34) and a detectable label (claim 37). Novak and the reference claims also claim methods of detecting the antibody by contacting the antibody with a sample. It would have been obvious to one of ordinary skill in the art at the time of filing to include a carrier and to conjugate the antibody with a detectable label to obtain the same benefits as in the reference claims and in Novak, e.g., administering the antibody (carrier) to detect the antibody (conjugation to a detectable label).
Regarding claim 6, Novak teaches humanizing the antibody (claim 20) and the reference claims are monoclonal (claim 1), making obvious these limitations.
Claims 2-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11732034. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 2, reference claim 15 is identical in scope to instant claim 2 (see above).
Instant claim 2—and all instantly pending claims—require a carrier. Only claim 15 of the reference document requires a carrier. As such, instant claims 3-12 do not fall under statutory double patenting as there is at least a minimal difference in scope. However, these claims represent obvious, patentably indistinct variants.
Regarding claims 3-5 and 7-12, the reference document claims the same sequences for the heavy and light chains (claims 2-11).
Regarding claim 6, the reference document claims the antibody is a monoclonal humanized antibody (claim 5).
The above claims all require a carrier. The reference claim 15 includes a carrier, making this an obvious variation to the other reference claims, arriving at the instant claims.
Allowable Subject Matter
The instant claims are allowable for the same reasons as set forth in parent applications 15/742087, 16/409945, and 17/136189, now US 10287343, US 10889640, and US 11732034, respectively. Briefly, CDRs represent the binding functionality of an antibody and even single amino acid changes are unpredictable (see Chen and Kussie; cited on IDS). As the instant CDRs were not discovered in the prior art, these CDRs are novel and non-obvious as, without a clear teaching to arrive at these sequences, the CDRs could not be a priori predicted to bind tau.
For US 10889640, the reference claims are all directed to amino acid sequences of SEQ ID NOs: 7 and 8, or nucleic acids encoding the same. While the instant independent claim—broadly encompassing any antibody with the claimed CDRs—is anticipated by the reference, the instant dependent claims set forth specific heavy and light chains. These sequences (9-14 and 17-18) are not the same as SEQ ID NOs: 7 or 8. As such, claims limited to these full variable regions are considered patentably distinct as there is no clear motivation to make these mutations which humanize the antibody.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20140294724 (form 892) and US 20120087861 (form 892) are cited as relevant to the ubiquity of adding carriers and detectable labels to tau antibodies.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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/Adam Weidner/ Primary Examiner, Art Unit 1675