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 21-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12115282. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to “A knitted biodegradable polymeric vascular graft or conduit comprising polylactic acid coated with a copolymer of polyglycolic acid and polycaprolactone, the scaffold having a porosity allowing attachment of an effective amount of viable cells of between about 0.5×10.sup.3 cells/mm.sup.2 graft and 300×10.sup.3 cells/mm.sup.2 graft, inclusive, to reduce or prevent post-operative stenosis of the graft relative to the graft without the cells or with fewer cells prior to implantation.” while the instant claims are drawn to “A knitted biodegradable polymeric vascular graft or conduit comprising a polymer selected from the group consisting of polylactic acid, polyglycolic acid, and polylactide-co-glycolide coated with a copolymer of polycaprolactone and a polymer selected from the group consisting of polylactic acid, polyglycolic acid, and polylactide-co-glycolide, the scaffold having a porosity allowing attachment of an effective amount of viable cells of between about 0.5 X 10³ cells/mm² graft and 300 X 10³ cells/mm² graft, inclusive, to reduce or prevent post-operative stenosis of the graft relative to the graft without the cells or with fewer cells prior to implantation.” The patented are a more specific version of the more generic instantly claimed graft and this anticipate the claimed invention rendering it unpatentable
Claims 21-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11541149. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to “A patient-specific tissue engineerable biodegradable polymeric vascular graft or conduit comprising nanofibers of electrospun polymer, wherein the polymer is selected from the group consisting of poly(lactic acid-glycolic acid), poly(lactic acid), poly(glycolic acid) and poly(caprolactone), wherein the graft or conduit comprises pores between 5 and 500 microns in diameter allowing infiltration of cells as the polymer degrades, wherein the graft or conduit conforms to a variable and complex geometry of an artery or vein within a patient.” while the instant claims are drawn to “A knitted biodegradable polymeric vascular graft or conduit comprising a polymer selected from the group consisting of polylactic acid, polyglycolic acid, and polylactide-co-glycolide coated with a copolymer of polycaprolactone and a polymer selected from the group consisting of polylactic acid, polyglycolic acid, and polylactide-co-glycolide, the scaffold having a porosity allowing attachment of an effective amount of viable cells of between about 0.5 X 10³ cells/mm² graft and 300 X 10³ cells/mm² graft, inclusive, to reduce or prevent post-operative stenosis of the graft relative to the graft without the cells or with fewer cells prior to implantation.” and differences in concentration (in this case concentration or pores, i.e. porousity) will not generally support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. Where general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Note that the instant specification (same for the patent and application) defines electrospinning (as from the patented claims) as a type of knitting [068].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657
