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 .
Response to Amendment
The amendment filed 09/21/2026 has been entered. Applicants’ amendments to Claim 43 and 44 have overcome objections for minor informalities previously set forth in the office action mailed 06/23/2026. Applicants’ amendments to Claim 14 have overcome rejections for 35 USC 112(d), previously set forth in the office action mailed 06/23/2026. Newly amended claims 1, 3-4, 14, 22, and 43-44 are pending in the application, claims 2 and 34 are canceled, and claims 1, 3-33, and 35-50 are examined on the merits.
Rejections and/or objections not reiterated from the previous office action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Response to Arguments
Regarding the statutory double patenting rejection for claims 1-27, 32-33, 35-36, and 38 over claims 1-23 and 25-30 in U.S. Patent No. 12,312,335, Applicant argues that Claim 1 has been amended to include two additional X-ray diffraction peaks from claim 2, and the phrase “selected from one or more of the following” has been replaced with “comprising” in Claims 1, 3, and 4.
Applicants’ arguments, see remarks, filed 09/21/2026, with respect to Claims 1-27, 32-33, 35-36, and 38 have been fully considered and are persuasive. The statutory double patenting rejection over U.S. Patent No. 12,312,335, for Claims 1-27, 32-33, 35-36, and 38 has been withdrawn.
Regarding the statutory double patenting rejection for claims 4-10 over claims 1-7 of copending Application No. 19/202,127, applicant argues that since copending application ‘127 has not yet been examined, the claims should be allowed to mature into a patent, and any overlap in subject matter can be dealt with during prosecution of copending application ‘127.
Regarding the statutory double patenting rejection, the Examiner acknowledges/appreciates Applicant’s acknowledgement that it is difficult to compare the scope of claims in copending applications undergoing prosecution. Regrettably, the Examiner cannot hold the rejection in abeyance until allowable subject matter has been determined.
The rejection has been modified in light of claim amendments in the instant application.
Regarding the non-statutory double patenting rejection over Claims 28-31, 37, and 39-44 over U.S. Patent No.12,312,335 in view of Hanes, the applicant filed a terminal disclaimer over U.S. Patent No.12,312,335.
In light of the filing of the terminal disclaimer, the examiner withdraws the previous nonstatutory double patenting rejection over U.S. Patent No.12,312,335 in view of Hanes for claims 28-31, 37, and 39-44.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 37 contains the trademark/trade names “antegren”, “Neurelan”, “campath”, “differin”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe natalizumab, fampridine-SR, alemtuzumab, and adapalene, and, accordingly, the identification/description is indefinite.
Regarding claim 37, the phrase “NBI 5788/MSP 77” renders the claim because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear if the claims are limited to NBI 5788/MSP 77 in general or specifically limited to tiplimotide, because it is unclear if the phrase within the parenthesis is part of the claimed invention or meant to limit the claim.
Regarding claim 37, the phrase “Anergix.MS” renders the claim because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear if the claims are limited to Anergix.MS in general or specifically limited to AG 284, because it is unclear if the phrase within the parenthesis is part of the claimed invention or meant to limit the claim.
Regarding claim 37, the phrase “BAY 361677” renders the claim because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear if the claims are limited to BAY 361677 in general or specifically limited to interleukin-4, because it is unclear if the phrase within the parenthesis is part of the claimed invention or meant to limit the claim.
Regarding claim 37, the phrase “interferon-tau” renders the claim because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear if the claims are limited to interferon-tau in general or specifically limited to trophoblastin, because it is unclear if the phrase within the parenthesis is part of the claimed invention or meant to limit the claim.
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 1, and 3-21 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-18 of copending Application No. 19/202,127, herein ‘127.
Regarding instant Claim 1, and 3-4, Claim 1 in copending application ‘127 discloses
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Copending application ‘127 states “selected from one or more of the following” and lists the X-ray diffraction powder (XRPD) peaks for a polymorph of varoglutamstat hydrochloride, as the peaks disclosed in instant Claims 1, and 3-4. Instant Claim 1 uses the claim language “comprising” to describe the XRPD peaks, which is open claim language, meaning that additional peaks not listed in instant Claim 1 would still fall within the scope of the copending claim.
Therefore, it would have been prima facie obvious for one of ordinary skill, to take the XRDP peaks of a polymorph of varoglutamstat hydrochloride as disclosed in copending application ‘127, to arrive at the limitations of instant Claim 1, and 3-4, because Claim 1 in copending application ‘127 discloses the 4 XRPD peaks disclosed in instant Claim 1, and additional peaks disclosed in Claims 3 and 4. Therefore the scope of copending claim 1 is the same as instant claim 1, since the term “selected from one or more” in copending claim 1, reads on all of the peaks disclosed in instant Claim 1, and render the instant claims obvious.
Regarding instant Claims 5-13, Claims 2-10 in copending application ‘127 disclose:
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Regarding instant Claims 14-18, Claims 11-15 in copending application ‘127 disclose:
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Regarding instant Claims 19-21, Claims 16-18 in copending application ‘127 disclose:
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This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claims 22-33, and 35-50 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIERRA M ROCHELLE whose telephone number is (571)272-9962. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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/C.M.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
