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 .
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 43-47, and 54-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10.064,404. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims provide for a composition that reads upon, and is thusly anticipated, by the cited patent.
The patent provides for a composition comprising a halogenated disaccharide and an anticoagulant, wherein the disaccharide is provided at between 0.1-50 µM; dependent claims further define the type of anticoagulant and the type of halogenated disaccharide.
The cited claims of the instant claim-set provide for, at least, a di-chlorinated disaccharide and an anticoagulant. The cited claims are slightly narrower, in the sense that the independent claim only claims a specific halogen, of specific number, whereas the patent provides for di- and tri-halogenated disaccharides with any halogen. The claims of the patent anticipate the instantly claimed composition, and as such, provide for non-statutory double patenting of the cited claims.
Claims 43-47, and 54-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-10 of U.S. Patent No. 10,772,319. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent describes a method of stabilizing thrombocytes using a composition comprising a buffer, an anticoagulant, and a halogenated disaccharide, wherein the patent sets the pH at between 4-.0-9.0.
The cited claims of the instant claim-set provide for, at least, a di-chlorinated disaccharide and an anticoagulant. The cited claims are slightly narrower, in the sense that the independent claim only claims a specific halogen, of specific number, whereas the patent provides for di- and tri-halogenated disaccharides with any halogen. Based upon the composition described in the patent, the composition of the instant invention would be anticipated; since there is no bar with respect to double patenting rejections between inventions of different statutory categories, the instant invention appears to be non-statutory double patenting with the cited patent.
Claims 48-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,672,247. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent provides for a composition that would anticipate the composition described in the cited claims
The patent provides for a composition comprising a pH buffer, a halogenated disaccharide, and a polyol. The claims cited in the application provide for a buffer that is explicitly described, a di- or tri-chlorinated disaccharide, and a pentose or hexose polyol that is explicitly described.
The instant application provides for claims that are slightly narrower than that of the patent, because the patent provides for an independent claim that broadly describes the buffer type, disaccharide, and polyol, whereas the claims in the application provide for subcategories of those described in the patent. Therefore, the claims of the patent anticipate the claims of the instant claim-set.
Claims 43-47, and 54-62 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 11 and 16 of U.S. Patent No. 11,672,247. Although the claims at issue are not identical, they are not patentably distinct from each other. See the description of the ‘247 patent in the non-statutory double patenting rejection above. These cited claims (9, 11, and 16) all provide for a further limitation drawn to an anticoagulant, which would directly read upon claims 43-47 and 54-62.
Claims 43-47, and 54-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,121,022. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent provides for a method and composition that read upon the cited claims. The patent provides for a composition and method that utilize a halogenated disaccharide, and an anticoagulant. Similar to the patent, the instant application provides for claims that include a halogenated disaccharide, and an anticoagulant. Based upon the clear overlap in limitations, and the fact that the composition and method entirely read upon, and thusly anticipate, the claimed composition, the instant invention is non-statutory double patenting with the cited patent.
Claims 48-53 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 and 17 of U.S. Patent No. 12,121,022. Although the claims at issue are not identical, they are not patentably distinct from each other. See the discussion of patent ‘022 above. The cited claims also include the polyols claims in claims 48-53. As such, claims 6 and 17 read upon the cited claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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