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 54-57, 59-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,938,253 to Roy et al. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
With regard to claim 54, patented claim 1 sets forth a blood oxygenation device with a blood channel and a gas channel, and a gas exchange composite comprises a nonporous gas permeable membrane, a noncompliant microporous membrane with gas diffusion windows and struts with micropores, wherein the first surface of the polymeric membrane provides an antithrombotic surface for gas exchange over the windows.
With regard to claim 55, Applicant is setting forth a second gas channel with a membrane. It has been held that the mere duplication of the parts of an apparatus found in the prior art is not patentably significant unless a new and unexpected result is produced. See MPEP § 2144.04 (VI)(B).
With regard to claims 56, 57, see patented claims 3 and 2, respectively. With regard to claims 59-60, see patented claims 4-5, respectively.
With regard to claims 61-71, 89, the limitations are drawn to generic features of blood oxygenators that are common in the art. However, they depend from claim 54 which would be patentable over the prior art upon filing of a Terminal Disclaimer to US Patent No. 11,938,253.
Claims 72, 73, 88, 93-97 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,938,253 to Roy et al in view of claims 2, 10, 16-21 of U.S. Patent No. 10,695,480 to Roy et al. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
With regard to claims 72 and 73, Roy ’253 sets forth the device of claim 54 (see rejections above), and claims 17 and 18 of Roy ’480 sets forth the functionalization of the channel with heparin.
With regard to claims 88, 93, 94, 95, 96, 97, see Roy ’480 claims 10, 2, 16, 19 , 20, 21 respectively.
Claims 87, 90, 91 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,938,253 to Roy et al in view of U.S. 2016/0058933 to Ballantyne et al. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
With regard to claims 87, 90, and 91, Roy ’253 sets forth the device of claim 54 (see rejections above). Ballantyne discloses an extracorporeal blood treatment device that incorporates peristaltic pumps, a gas supply with a flow conduit, and a heparin pump, demonstrating that all these elements are known in the art. It would have been within the skill of a person in the art to add the conventional extracorporeal elements disclosed by Ballantyne to the gas exchange medium claimed by Roy ’253 in order to arrive at the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 4 March 2026