Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 77-86 are pending in the instant application.
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 77-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11, 292,845; 10,233,245; 9,493,567. Although the claims at issue are not identical, they are not patentably distinct from each other because patents recite a method of using natalizumab to treat a patient with an inflammatory or autoimmune disease comprising: (a) administering a pharmaceutically effective amount of natalizumab to the patient; (b) monitoring the patient for indicators of progressive multifocal leukoencephalopathy (PML), wherein the monitoring comprises detecting seroconversion and/or an increasing titer of JC virus (JCV) antibodies in the patient's blood; and (c) discontinuing the administration of natalizumab in the presence of seroconversion and/or an increasing titer of JCV antibodies; wherein the monitoring improves the safety of the treatment (see US 11,292,845 at claim 1), wherein the disease is multiple sclerosis (see claim 2), wherein the monitoring further comprises testing for clinical and/or radiologic symptoms of progressive multifocal leukoencephalopathy (PML) (see claim 7). wherein detecting seroconversion and/or an increasing titer of JCV antibodies in the patient's blood comprises serially removing samples of the patient's blood, measuring the amount of IgG anti-JCV antibodies in the samples, and comparing the amount of the anti-JCV antibodies in the samples (see claim 15).
The instant and copending claims anticipate or render obvious one another over the same or nearly the same methods of treating with natalizumab and testing and monitoring the risk and complications of PML and JC virus infections associated with natalizumab treatment.
Claims 77-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 12,105,090. Although the claims at issue are not identical, they are not patentably distinct from each other because patent recites a method of treating a Multiple Sclerosis (MS) patient, the method comprising obtaining a biological sample from the patient, and responsive to a determination that the sample is negative for anti-JCV antibodies, administering to the patient an anti-VLA-4 therapy, said determination comprising: measuring an anti-JC Virus (JCV) antibody titer reactivity index corresponding to an anti-JCV antibody titer by normalizing an OD value of the biological sample to a cut-off calibrator, said cut-off calibrator comprising a mixture of serum positive for anti-JCV antibodies and serum negative for anti-JCV antibodies and having a reactivity index of 1, wherein the anti-JCV antibody titer reactivity index is determined by an immunoassay to detect anti-JCV antibody in the sample; classifying said sample as negative when said nOD value is less than 0.2 and positive when said nOD value is greater than 0.4, and responsive to a level of anti-JCV antibody corresponding to a nOD value between 0.2 and 0.4, measuring a percent inhibition by (i) separating said biological sample into a first aliquot and a second aliquot and pre-incubating the first aliquot in absence of highly purified virus-like particle (HPVLPs) in solution and pre-incubating the second aliquot in presence of HPVLPs in solution under conditions suitable for binding of an anti-JCV antibody in the second aliquot to HPVLPs in solution; and (ii) detecting a level of unbound anti-JCV antibody in each of the first aliquot and the second aliquot capable of binding to HPVLP disposed on a substrate to measure the percent to which HPVLP in solution inhibits anti-JCV antibody in the second aliquot from binding the HPVLP disposed on the substrate, and classifying said sample as negative when said inhibition is less than 45% (see claim 1), wherein the anti-VLA-4 therapy is natalizumab (see claim 10), wherein an increase in anti-JCV antibody titer indicates an increase in the patient's risk of developing PML (see claim 4).
The instant and copending claims anticipate or render obvious one another over the same or nearly the same methods of treating with natalizumab and testing and monitoring the risk and complications of PML and JC virus infections associated with natalizumab treatment.
Claim Rejections - 35 USC § 112, 4th paragraph
The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
Subject to the [fifth paragraph of 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.
Claim 79 is rejected under 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. Claim 79 recite detecting JCV in the urine, blood, and cerebrospinal fluid; however, only blood sample is tested in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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