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/Restriction
Applicant’s election without traverse of Group I in the reply filed on December 1, 2025, is acknowledged. Claims 1-18 are pending of which claims 14-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-13 have been examined on the merits.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Owen et al (US 6,673,594 B1; IDS).
The instant claims are drawn to a prefusion device comprising a container, a pump, vessels of which at least one comprioses perfusate, and a sterile insert. The claims are further drawn to providing the device with a display and configurations for parameters including perfusion/pump activation, flow, and tissue oxygenation.
Owen ‘594, however, teaches a perfusion device (see entire document, e.g. at fig 11, and at col. 10), wherein the device comprises a rectangular container suitable for an ex vivo tissue/organ (60) or a plurality thereof (fig 12 for example), received in one or more cassettes (40, 65) (broadly, a rectangular container having at least one aperture dimensioned, as required of instant claim 1). The devices disclosed therein may be “fitted with modules” optionally in combinations (“that may be stacked”) to provide functions or combinations including for pump, filtration, oxygenation and/or debubbling, and selected to provide support of the ex vivo tissue including the benefit of to “prevent protein deprivation, enhance biocompatibility with, for example, blood and to reduce clotting tendencies” (broadly, a plurality of vessels coupled to or suitable to, the pump and tissue), and further “may be configured to provide uninterrupted sterile conditions or with check valves or filters “may also be used to prevent biological materials, such as bacteria and viruses, from being transferred” (broadly a sterile insert configuration; also filter (2020); a filter as required of claim 10). Additionally, the device may be provided with reservoir tanks (10, 15a,15b,17) in fluid communication therewith (a reservoir, as required of claim 12), The device is further disclosed as optionally containing automated and/or manual controlling (e.g. “manual actions require the user to act, for example by pressing a button or turning a knob or dial”) and/or analysis and diagnostic functionality, including sensors, controllers, temperature controllers, perfusion fluid input and output analysis, oxygenators, pressure sensors, pH detectors, oxygen sensors, and flow meters, and operated through displayed and selected/selectable menus or programs therefor (as required of claims (broadly an external display and the configurations and components as required of claims 4, 5, 11). Handles (68) and “straps and/or wheels to assist in carrying” may be provided (as required of instant claim 3); with batteries or rechargeable and swappable batteries (2030) (as required of claim 8); or with a sensor arrangement configuration detecting of the organ and fluid “which shuts down the system if the fluid pressure in the tubing 91 exceeds a predetermined limit, or activates an alarm to notify the operator that the system should be shut down” (broadly, a warning system as required of instant claim 9) .
Although the reference does not expressly recite positioning as coupled to the side of the rectangular container, it would have been prima facie obvious and a matter of mere judicious design choice to provide an equivalent arrangement which also would provide or maintain sterility. Further, the contents of the device (the perfusion fluid additives) do not materially alter the device components (rather describe the contents) and are not considered to further patentably distinguish the device and components arrangement, however, in the alternative based on the teachings of the cited reference of Owen and level of skill and knowledge in the art of organ preservation, one would have been motivated to have provided conditions to minimize infection (providing antibiotics), reducing clotting (providing heparin and/or tPA), and appropriate physiological fluid balance (saline, blood products) to support viability and would have been prima facie obvious to so provide. Additionally, wheels are well-known in the art, and as such, including as taught instantly regarding assisting in transport, then absent a showing of criticality or a new and unexpected effect upon providing in the arrangement instantly claimed, it would have been a mere matter of judicious design choice to locate wheels along the rectangular container.
The claims are distinguished in that the prior art teaches normo- and hypothermic temperatures, and such thermal treating of organs, however does not teach an arrangement of the device comprising such an external collection apparatus suitable for the use therewith, to chemically cool the ex vivo tissue, prior to attachment of the vessels as instantly claimed.
Consequently, it would have been at least obvious to have provided a device as instantly claimed for the preserving and perfusing of an organ, based on the teachings of the cited reference and level of ordinary skill and knowledge of one in the art.
Owen et al is relied upon for the reasons discussed above. If not expressly taught by the reference, based upon the overall beneficial teaching provided by this reference with respect to the monitoring and controlling of perfusion and perfusate of a tissue/organ therewith in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable preserving-condition parameter and ranges and arrangement in which to provide such device), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was effective filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Owen et al (US 6,673,594 B1; IDS) as applied to claim 1-6 and 8-12 above, and further in view of Sherman (US 5,891,159 A; IDS).
The claims and teachings of Owen ‘594 are as of record above. Owen further teaches that the tissue/organ may be attached by sutures, including teaching “an end of the tubing 50c is inserted into the organ 60. The tubing may be connected to the organ(s) with conventional methods, for example, with sutures”.
However, the claims are distinguished in that the claims further recite providing the device with purse string suture integrations (as required of claim 7).
It would have been obvious at the time of the instant invention effective filing to have provided sutures, because Owen teaches so providing sutures (as identified above), and would have provided purse string sutures, because in the art of surgery and tissue sutures, including as taught by Sherman ‘159, it was known that purse string sutures were frequently used in such surgical procedures to close a tubular section of tissue, and with vascular tissues (e.g. heart) to effect major arteries, and/or major veins for cannulation (fluid routing/bypass)” (e.g. col 1, at lines 12-19). One would have been motivated to have used purse string sutures, because Sherman teaches that such sutures were effective and “used to seal the tissue around a cannula placed within” the tissue.
Owen and Sherman are is relied upon for the reasons discussed above. If not expressly taught by the references, based upon the overall beneficial teachings provided and in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable suture or purse sting or other known suture thereamong, in which to perform such a cannulation), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was effective filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ product (perfusion device) with that 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
Claim 13 is objected to because of the following: Claim 13 is objected to as depending from a rejected base claim. Appropriate correction, amendment, or other appropriate response is required.
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