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 .
Election/Restrictions
Applicant’s election Group I in the reply filed on October 15, 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-25 are pending of which claims 10-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Pending claims 1-9 have been examined on the merits.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 6, and 7 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Badiwala et al (US 20200120924 A1).
The instant claims are drawn to a device (“system”) comprising:
a reservoir;
a pump;
an oxygenator;
adapters for fluidly connection to an ex-vivo (a) right atria, (b) pulmonary artery, (c) left atria, and (d) aorta;
a network of conduits that fluidly couple (i-iv); and
a plurality of valves coupled to the conduits;
wherein the system is configurable to the following modes, directing perfusate:
to coronary arteries (Langendorff Perfusion Mode);
to a left half of the heart (Isolated Left Heart Working Mode);
to a right half of the heart (Isolated Right Heart Working Mode); and
to both the left half and the right half of the heart (Whole Heart Working Mode).
The disclosure further teaches that the “valves” broadly include clamps disclosing that “[i]n FIG. 1, valves (e.g., clamps or other occlusion devices) at points 52, 54, 56, and 58…” (see para [0038]).
Badiwala et al ‘924, however, anticipates the claims by teaching an ex-vivo perfusion device, including the device of fig 1A (as reproduced below):
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530
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The device, comprises a reservoir (110), perfusion and oxygenating pumps (131-132) and oxygenator (120), adaptors (205,215,211,220) fluidly connected respectively to the right atria, pulmonary artery, left atria, and aorta; a network of conduits that fluidly couple (181-189; and broadly interpreted as comprising an aortic inlet, outlet and Langendorff port as required of claim 6); and a plurality of valves (including scissors/clamps) coupled to the conduits (depicted by scissors in fig 1A, (141-145). The system is expressly taught and implied by the ability to selectively clamp/valve-close one of more of the associated conduits, then the device of Badiwala et al based on the finite combinations useful thereamong, is broadly and reasonably interpreted as to be a configuration suitable for perfusate directing as required of instant claim 1 (including to coronary arteries (Langendorff Perfusion Mode), and/or to a left and/or right half of the heart (Isolated Left. Isolate Right, or Whole Heart Working Modes) (see ‘924, fig 1A and at para [0060-0085]). Additionally, the device as configured and being suitable for sampling metabolites and adjusting perfusate flow (see [0080-0085]; broadly, a configuration operable to restore and maintain normothermic heart metabolism and assessing function, as required of instant claim 7).
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Claim Objections
Claims 2-5, 8, and 9 are objected to because of the following: The claimed are objected to as depending directly or indirectly from rejected claims, which are rejected for the reasons set forth above.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON J KOSAR/Primary Examiner, Art Unit 1655