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 Preliminary Amendment filed 01/23/25 is acknowledged and has been entered. Claims 1-18 have been canceled. New claims 19-33 have been added. Accordingly, claims 19-33 are pending and under examination.
Specification
The disclosure is objected to because of the following informalities: The specification on page 1 should indicate the current status of all nonprovisional parent application references. For example, after the disclosure “U.S. Application No. 18/330,550, filed on June 7, 2023”. Applicant should insert --, abandoned--.
Appropriate correction is required.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 19-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,775,386 in view of Digenio (US 2018/0245076).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and US 10,775,386 are directed to a method of detecting neutralizing antibodies in a sample comprising the steps of:
(a) inactivating leptin present in the sample; (b) adding a known quantity of labeled leptin to the sample; (c) contacting the sample containing labeled leptin of (b) with a substrate capable of binding the labeled leptin, wherein said substrate capable of binding the labeled leptin comprises (i) a coated matrix, an antibody bound to the coated matrix, and a tagged leptin receptor bound to the antibody, or (ii) a coated matrix bound to a tagged leptin receptor; (d) washing the substrate to remove unbound labeled leptin; and (e) measuring the label signal produced by the substrate-bound labeled leptin; (f) measuring a negative control signal, said negative control signal produced by completing steps (a)-(e) in a control blood, serum, or plasma sample that does not contain neutralizing antibodies to leptin; and (g) comparing the signal from (e) with the signal from (f), wherein if the level of signal measured in (e) is greater than or equal to the level of signal measured in (f), then the sample does not contain neutralizing antibodies to leptin, and wherein if the level of signal measured in (e) is less than the level of signal measured in (f), then the sample contains neutralizing antibodies to leptin. U.S. 10,775,386 fails to teach the detection of anti-metreleptin antibodies. However, Digenio teaches that it is known in the art that metreleptin is commercially available for patients with Generalized Lipodystrophy and that the use of metreleptin may cause the development of neutralizing antibodies to leptin or metreleptin (e.g. para. 0008). Therefore, it would have been obvious to one of ordinary skill in the art at the filing date of the invention to incorporate metreleptin for the leptin in the method of US 10,775,386 for the detection of neutralizing antibodies to metreleptin.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hauenstein et al (US 2013/0266963) discloses a method for detecting neutralizing antibodies in a sample (e.g. para’s 0016-0030, 0365). Hauenstein et al discloses contacting the sample with labeled biologic and contacting the sample with a substrate capable of binding the biologic and measuring signal (e.g. para’s 0016-0030). Hauenstein et al discloses that the neutralizing antibodies can be to leptin (e.g. para 0368). However, Hauenstein et al does not suggest or disclose inactivating leptin present in the sample and performing the method as claimed.
Paz-Filho et al (Metabolism Clinical and Experimental 64, 2015, pages 146-156) teaches metreleptin is a form of leptin that is currently available for human therapy. Paz-Filho et al teaches that the metreleptin is recombinant methionyl human leptin and is the only pharmaceutical form of leptin and is composed by the 46 amino acids of mature human leptin, with an additional methionyl residue at the N-terminal end of the recombinant protein (e.g. page 147).
Chan et al (Clin Endocrinol, 2016 July; 85 (1), pages 137-149). Chan et al teaches that anti-metreleptin antibodies develop in patients with treatment of metreleptin (e.g. page 137).
Wu et al (Practical and Applied Considerations, June 20, 2011, Chapter 10, pages 175-192) discloses different competitive assay formats for the detection of neutralizing antibodies.
Rajadhyaksha et al (2016/0252520) discloses an assay for detecting the presence of neutralizing antibodies.
Digenio (US 2018/0245076) discloses that patients exposed to metreleptin develop anti-drug antibodies which neutralize activity of leptin (e.g. para’s 0527-0529).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678
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