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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
In claim 26, the claim limitations: “An apparatus for use with at least one pair of chambers including an inflow chamber, an outflow chamber, and a valve between the inflow chamber and the outflow chamber” and “said at least one pressure regulation device being fluidically connectable both to the inflow chamber by an inflow branch and to the outflow chamber by an outflow branch“ do not have proper antecedent basis in the specification.
The claim language is not considered to constitute new matter, as the underlying subject matter is fairly taught in the original disclosure. Amendment of the specification to add corresponding language at appropriate locations would overcome the objection.
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 16-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,735,066. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed subject matter is recited or suggested in the claims of the ‘066 patent, as follows:
Claim 16
Claims of ‘066 patent
An assembly comprising:
Claim 1: A test bench assembly for simulating cardiac surgery and/or interventional cardiology operations and/or procedures, comprising:
a passive heart, wherein said passive heart is an explanted or artificial or hybrid heart, said passive heart having at least one pair of cardiac chambers comprising an atrial chamber and a ventricular chamber;
Claim 1: a passive heart, wherein said passive heart is an explanted or artificial or hybrid heart, said passive heart having at least one pair of cardiac chambers comprising an atrial chamber and a ventricular chamber;
said passive heart further comprising at least one outflow valve positioned at an outlet of said ventricular chamber of said at least one pair of cardiac chambers;
Claim 8: The test bench assembly of claim 1, wherein said systole branch and said diastole branch are joined in a section which flows into said compliant element.
a reservoir, adapted to house working fluid;
Claim 1: a reservoir, adapted to house working fluid;
a pressure generator, adapted to provide said passive heart with a pumping function by pumping said working fluid, said pressure generator being fluidically connected both to said ventricular chamber of said passive heart by at least one ventricular conduit and to said reservoir by a reservoir conduit;
Claim 1: a pressure generator, adapted to provide said passive heart with a pumping function by pumping said working fluid, said pressure generator being fluidically connected both to said ventricular chamber of said passive heart by at least one ventricular conduit and to said reservoir by a reservoir conduit;
at least one pressure regulation device which provides the working fluid in input to the atrial chamber with preload pressure and the working fluid in output from the ventricular chamber and downstream of the outflow valve with afterload pressure;
Claim 1: at least one pressure regulation device which provides the working fluid in input to the atrial chamber with preload pressure and the working fluid in output from the ventricular chamber with afterload pressure;
said at least one pressure regulation device being fluidically connected both to said atrial chamber of said passive heart by a diastole branch and to said ventricular chamber of said passive heart through said outflow valve, by a systole branch;
Claim 1: said at least one pressure regulation device being fluidically connected both to said atrial chamber of said passive heart by a diastole branch and to said ventricular chamber of said passive heart by a systole branch;
wherein said pressure generator comprises at least one flow intercepting element, which selectively allows direct fluid connection between said passive heart and said reservoir.
Claim 9: The test bench assembly of claim 1, wherein said pressure generator comprises at least one flow intercepting element, and wherein the at least one flow intercepting element selectively allows direct fluid connection between said passive heart and said reservoir.
The limitations of claim 17 are recited in claim 4 of the ‘066 patent.
The limitations of claim 18 are recited in claim 5 of the ‘066 patent.
The limitations of claim 19 are recited in claim 19 of the ‘066 patent.
The limitations of claim 20 are recited in claim 10 of the ‘066 patent.
The limitations of claim 21 are recited in claim 11 of the ‘066 patent.
The limitations of claim 22 are recited in claim 12 of the ‘066 patent.
The limitations of claim 23 are recited in claim 13 of the ‘066 patent.
The limitations of claim 24 are recited in claims 1, 20 and 21 of the ‘066 patent.
The limitations of claim 25 are recited in claim 16 of the ‘066 patent.
Claim 26 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 12,125,403. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed subject matter is recited or suggested in the claims of the ‘463 patent, as follows:
Claim 26
Claim 20 of ‘403 patent
An apparatus for use with at least one pair of chambers including an inflow chamber, an outflow chamber, and a valve between the inflow chamber and the outflow chamber, the apparatus comprising:
An apparatus for use with an explanted organ, the explanted organ having at least one pair of chambers including an inflow chamber and an outflow chamber, the apparatus comprising:
a reservoir, adapted to house working fluid;
a reservoir, adapted to house working fluid;
a pressure generator, adapted to pump said working fluid within the inflow chamber and the outflow chamber, said pressure generator being fluidically connectable both to the outflow chamber by at least one outflow conduit and to said reservoir by a reservoir conduit; and
a pressure generator, adapted to pump said working fluid within the explanted organ, said pressure generator being fluidically connectable both to the outflow chamber of the explanted organ by at least one outflow conduit and to said reservoir by a reservoir conduit; and
at least one pressure regulation device which provides the working fluid in input to the inflow chamber and the working fluid in output from the outflow chamber with afterload pressure;
at least one pressure regulation device which provides the working fluid in input to the inflow chamber and the working fluid in output from the outflow chamber with afterload pressure;
said at least one pressure regulation device being fluidically connectable both to the inflow chamber by an inflow branch and to the outflow chamber by an outflow branch;
said at least one pressure regulation device being fluidically connectable both to the inflow chamber of the explanted organ by an inflow branch and to the outflow chamber of the explanted organ by an outflow branch;
wherein said at least one pressure regulation device comprises a single compliant element for each pair of chambers, said single compliant element providing the working fluid with both preload pressure and afterload pressure.
wherein said at least one pressure regulation device comprises a single compliant element for each pair of chambers, said single compliant element providing the working fluid with both preload pressure and afterload pressure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KURT FERNSTROM whose telephone number is (571)272-4422. The examiner can normally be reached M-F 10-6.
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/KURT FERNSTROM/Primary Examiner, Art Unit 3715
June 4, 2026
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