DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment, filed 06/25/2024, has been entered.
Claims 1-145 have been canceled.
Claims 146-164 are pending and currently under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 150-155 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter Rejection.
The newly added claims recite that T2 lesion volume shrinks by at least 0.127, 0.254, or 0.381 cm³; claims 153–155 further require that reduction from baseline to week 120.
The closest support in the specification as-filed is Table 12B, which reports 12.7 cm³ as the mean baseline T2 lesion volume for the ocrelizumab group, and paragraph [0078], which reports a 3.4% decrease from baseline to week 120. Although multiplying 12.7 cm³ by 1%, 2%, and 3% produces the claimed numbers, the specification does not report those absolute reductions for any patient or for the treatment group. The baseline figure is a group mean, and the reported percentage decrease is a statistical treatment result.
Accordingly, the specification as-filed does not provide sufficient written support for the particular absolute T2 lesion-volume reductions now recited in claims 150–155. As such, the claims now recite limitation which was not clearly disclosed in the specification as-filed and now change the scope of the instant disclosure as-filed. Such limitation recited in the present claims, which did not appear in the specification, as-filed, introduce new concept and violate the description requirement of the first paragraph of 35 U.S.C. 112.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 146–164 are rejected under 35 U.S.C. § 102(a)(1) and (a)(2) as anticipated by Smith et al. US 2010/0158903 A1; see entire document).
Smith et al. treating treating human patients with primary progressive multiple sclerosis (PPMS) by administering ocrelizumab (Example 4, paragraph 0445) . It describes a 600 mg regimen comprising two initial 300 mg infusions followed by 600 mg infusions every 24 weeks, and identifies change in total T2 lesion volume from baseline to week 120 as an efficacy endpoint. Although Smith does not expressly teach T2 lesion-volume shrinkage, given that the prior art taught the same method step, the treatment would result in T2 lesion shrinkage as recited in the present claims. MPEP § 2112; In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
Furthermore, Smith et al. taught PPMS patients with zero T1 gadolinium-enhancing lesions at baseline in Table 4. Its ocrelizumab treatment of progressive-MS patients also provides alternative eligibility criteria, so the presence of a Gd-enhancing lesion is not required to receive that treatment. Applicant’s published specification reports a 3.1% decrease in T2 lesion volume for ocrelizumab-treated PPMS patients without baseline Gd-enhancing lesions, corroborating the asserted results for this subgroup. Moreover, Smith et al. expressly identifies patients with gadolinium-enhancing lesions as candidates for anti-CD20 treatment and includes them in its progressive-MS ocrelizumab study (paragraph 0395).
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 146-164 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 9,994,642 (cited in IDS) and claims 1-28 of U.S. Patent No. 9,683,047 (cited in IDS) in view of Smith et al. (US 2010/0158903 A1). The patented claims disclosing a method of treating a patient with PPMS comprising administering to the patient effective amounts of ocrelizumab intravenously with the same schedule. It would have been obvious to one of ordinary skill in the art to arrive at the claimed methods in view of the teachings of Smith discussed above (see 102).
Claims 146-164 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 19/686,406; claims 1-32 of copending Application No. 19/686,345; claims 1-30 of copending Application No. 19/686,356; claims 1-20 of copending Application No. 19/686,353. Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims disclose the same method of treating PPMS patients comprising administering ocrelizumab. Furthermore, the copending claims would render obvious of the present claims in view of the teachings by Smith et al. as discussed above (see 102).
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
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/SHARON X WEN/Primary Examiner, Art Unit 1641
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