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 .
Claims 2-21 are pending and have been examined on the merits.
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 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,998,001 (claims 1-19).
Although the instant claims and conflicting (reference patent) claims are not identical, they are not patentably distinct in that each is drawn to a perfusion device arranged for brain perfusion (instant claims 2-14; ‘001 claims 1-19) and method of use threeof (instant claims 15-21; ‘001 claims 20-23), including a brain enclosure (‘001 at claims 1, 7, 9, 12-13), venous loop and an arterial loop (‘001 claims 7+), reservoir (‘001 claim 8), pulse generator (instant claim 3; ‘001 claims 2,6), sensors including “one or more sensors for measuring one or more properties of the perfusate selected from the group consisting of pH, dissolved oxygen concentration, dissolved carbon dioxide concentration, dissolved metabolite concentration, temperature, pressure, and flow rate.” (instant claims 4-5; ‘001 at claims 9-14). The device as claimed may further include a hemodiafiltration unit (instant claim 6-7; ‘001 at claims 1+), a perfusate pump (instant claims 6+; ‘001 at claims 7+) optionally coupled to temperature and oxygenation controls (instant claims 9-11; ‘001 at claims 1, 9-14), flow-regulating valves (instant claim 8; ‘001 at claim 9). The brain useful therewith include mammalian (instant claims 2+; ‘001 at claim 1) including human (instant claim 13; ‘001 at claim 4) or pig/porcine brains (instant claims 14; ‘001 at claim 3). Additionally, the device normal operation as implied thereof and supported by the instant and reference disclosures invoke that the device so arranged under normal operation may be operated to control perfusion of the brain as instantly claimed (see instant claim 15: “enclosing the mammalian brain in a brain enclosure unit of the ex-vivo perfusion system; fluidly coupling the mammalian brain to a fluid line of the ex-vivo perfusion system; and controlling a pulse generation system to provide pulsatile flow of the perfusate to the mammalian brain along the fluid line to perfuse the mammalian brain with the perfusate.”) and/or, also therewith controlling the temperature, dissolved oxygen, flow from the reservoir to pulse generator, filtering, flow-valve controlling, or performing testing upon the brain (see instant claims 16-21 respectively; see ‘001 at claims 1+ and as supported in the disclosure. Still further, the extent the claims are not identical, the mutually shared disclosures recite the features as features useful therewith, and therefore remain within the broad “comprising” scope of the claims; and, consequently, practicing at least one of the instant, or conflicting reference patent, claims would have at least rendered obvious the other invention as claimed.
Conclusion
No claims are presently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON J KOSAR whose telephone number is (571)270-3054. The examiner can normally be reached Mon.-Fri. 9-6 EST.
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/AARON J KOSAR/ Primary Examiner, Art Unit 1655
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