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 claim listing filed on 10/17/25 has been entered; no amendments are indicated. Claims 1-20 are pending.
Election/Restrictions
Applicants' election without traverse of “(b) antibody comprising heavy/light chain variable regions SEQ ID NO: 42/10” as the species of antibody in the reply filed on 10/17/25 is acknowledged. Claims 3, 5-6, 8-9, 11-12, 14-15, 17-18 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1, 2, 4, 7, 10, 13, 16 and 19 are under consideration, as they read upon the elected species.
Specification
The disclosure is objected to because of the following informalities:
---The title of the invention is not descriptive because it is directed broadly to any “antigen-binding protein”, a genus that encompasses other structures beyond antibodies, whereas the claimed invention is limited to monospecific antibodies. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “MONOSPECIFIC ANTIBODIES THAT ANTAGONIZE LEPTIN RECEPTOR”.
Appropriate correction is required.
Claim 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, 2, 4, 7, 10, 13, 16 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6, 8, 11, 14, 17, 20 and 23 of U.S. Patent No. 10,550,192, issued 2/4/20 (cited on a 3/18/25 IDS), and which shares the same applicant and inventors with the instant application, and further in view of Sandhu et al, 1992. Critical Reviews in Biotechnology. 12(5/6): 437-462.
Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Instant independent claim 1 encompasses an isolated monospecific antibody comprising 2 light chain variable regions (LCVRs) and two heavy chain variable regions (HCVRs) that are linked to heavy chain constant regions, inter-connected by disulfide bonds, wherein (a) the HCVRs comprise CDRs of a HCVR comprises an amino acid sequence set forth in a SEQ ID NO selected from a group including SEQ ID NO: 42 and (b) the LCVRs comprise the CDRs of LCVR that comprises the amino acid sequence set forth in SEQ ID NO: 10. The structure described by the claims corresponds to that of a full-sized antibody, having two pairs of HCVR/LCVRs that are connected by di-sulfide bonds. In view of the teachings of the specification at ¶ 90, the term “monospecific” means that the antibody binds to a single epitope on a single antigen; therefore, each of the two pairs of HCVR/LCVRs of the antibody bind to the same epitope.
Claim 1 of ‘192 encompasses an antibody that binds human leptin receptor (LEPR) and comprises (a) the CDRs of a HCVR that comprises the amino acid sequence set forth in a SEQ ID NO selected from a group including SEQ ID NO: 42 and (b) the CDRs of a LCVR that comprises the amino acid sequence set forth in SEQ ID NO: 10. While the claims of ‘192 are directed to an antibody having the same CDRs as in the instant claims, the claims of ‘192 do not expressly require that the antibody comprises two LCVRs linked to LC constant regions and two HCVRs that are linked to HC constant regions, inter-connected by disulfide bonds; i.e., a full-sized antibody.
Sandhu teaches the structure of a full-sized antibody, showing that it contains two LCVRs that are linked to LC constant regions and two HCVRs that are linked to HC constant regions, inter-connected by disulfide bonds; see Figure 1 on page 438. The figure shows that each pair of heavy and light chains are the same, indicating the molecule is monospecific. This is reinforced in the section on bispecific antibodies, which indicates that such is a “hybrid molecule that consists of nonidentical light and heavy chain pairs, resulting in two different antigen specificities” (page 447), indicating that the standard antibody has two identical light and heavy chain pairs and thus one antigen specificity; i.e., monospecific.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to take the antibody of any of the claims of ‘192 and modify it to be in the format of a full-sized antibody as taught by Sandhu, i.e., having two identical LCVRs that are linked to LC constant regions and two identical HCVRs that are linked to HC constant regions, inter-connected by disulfide bonds, and thus monospecific. The person of ordinary skill in the art would have been motivated to make such a change in order to produce an anti-LEPR antibody having the CDRs of the claims of ‘192 in the standard form of an antibody. The person of ordinary skill in the art would have had a reasonable expectation of success because Sandhu teaches that this is the general structure of an antibody and in the absence of evidence to the contrary would expect such a structure to work for any antibody that targets an antigen of interest, e.g., LEPR.
Instant claims 2, 4, 7, 10, 13, 16 and 19 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 ‘192 in the following manner:
Instant Claim
Claim of ‘192
2
2
4
13
7
4
10
23
13
11
16
17
19
20
As such, it would have further been obvious to make an antibody have any of the further embodiments of the claims of ‘192 when making the antibody of instant claim 1 that is obvious over the teachings of the claims of ‘192 in view of Sandhu.
Notes
No prior art has been identified that teaches or renders obvious an antibody having a heavy chain variable region (HCVR) having the CDRs of the HCVR of SEQ ID NO: 42 and having a light chain variable region (LCVR) having the CDRs a LCVR of SEQ ID NO: 10.
The instant application claims priority as a continuation to two parent applications:
---15/807,426, from which issued the ‘192 patent over which the claims are rejected for double patenting above.
---16/736,760, from which issued the patent U.S. 11,535,675 (cited on a 3/18/25 IDS). 16/736,760 claims priority as a divisional to parent application 15/807,426, and the claims of the ‘675 patent are directed to a different inventive group (a method of treatment). See the original restriction requirement issued in 15/807,425, mailed 4/16/2018, which restricts the claims to three inventive groups. The method claims were subsequently canceled by Applicants, and no rejoinder of the method claims was made in the ‘425 application. Thus, per MPEP 804.1, a non-statutory double patenting rejection of the instant claims over those of the ‘675 patent is prohibited by 35 U.S.C. 121.
Conclusion
No claims are allowable.
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