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 (i.e., changing from AIA to pre-AIA ) 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 10/20/23. Claims 86-112 are pending and under consideration.
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.
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Claims 86-112 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-93 of U.S. Patent No. 11667699 in view of Aste (US 20110286916; form 892) and Sanchez (US20100034736; form 892).
The instant claims are method of detecting MS4A4A by contacting an individual/sample with a specific antibody.
Instant independent claim 86 claims this method using the same antibody as reference claim 1.
Instant independent claim 87 claims this method using the same antibody as reference claim 53.
Instant independent claim 88 claims this method using the same antibody as reference claim 90.
Thus, the difference between the reference patent and the instant claims is that the reference patent claims a composition of matter (the antibody) while the instant application claims the same antibody in a method of use (detection). The reference patent claims the antibody as a fragment such as an Fab (claim 52).
This fact pattern was before the Court in Sun Pharmaceuticals v Eli Lily Fed Cir July 28, 2010; Geneva v GlaxoSmithKline 349, F.3d 1373; and Pfizer v Teva 518 F3d 1353, the decisions of which support the Office’s use of disclosed utilities of compositions when applying double patenting rejections to method claims.
It is noted that the instant application is a continuation of the reference patent; the specifications disclose the same methods in the same detail as instantly claimed. The reference specification clearly discloses the utility of the claimed antibody in a method of detection; see, e.g., C89, which discloses the utility of detection as well as supports such a claim with certain enabled means of doing so such as ELSIA or PET and radiolabeling the antibody.
In addition, Aste teaches antibodies may be radiolabeled (claim 33) to detect the corresponding antigen using known techniques such as immunoblot (claim 27), radioimmunoassay, ELISA (claim 44), and immunohistochemistry (claim 48).
Similarly, Sanchez teaches antibodies may be radiolabeled (claim 35) to detect (image) the corresponding antigen using known techniques such as PET, CT, and SPECT (claim 36).
Thus, taking the evidence as a whole, the reference specification discloses that one utility of the claimed antibody is for detection, making such a method obvious; these methods are allowed to be inspected by the decisions in, e.g., Sun. While the reference specification discloses the remaining details, these are also no more than what would have been obvious to the ordinary artisan at the time of filing as antibodies were routinely used to detect/quantify the antigen they bind, including radiolabeling and performing ELISA or PET on human samples or humans.
Therefore, claims 86-112 are an obvious variation of the patented claims.
Allowable Subject Matter
The instant claims are allowable for the same reasons as parent application 16/943123, now US 11667699. Briefly, alterations to the CDRs of an antibody are unpredictable. While the specification indicated that the antibodies started with the CDRs of a parent antibody (4A-202), a review of this document (WO 2019152715; citation FP1 on IDS 12/7/2020) did not discover the claimed combinations. Specifically, while the instantly claimed light chains were discovered (e.g., reference SEQ ID NO: 134), it does not appear that the ‘715 document discloses the same combinations of three heavy chain CDRs. Without clear motivation or teaching to arrive at the instantly claimed CDR combinations, one could not have predicted these claimed sequences would function predictably. Since the antibody is non-obvious, methods of using that antibody are also non-obvious.
Conclusion
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