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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/24/23 is being considered by the examiner.
Claims Status
Claims 1-15 are pending and are examined.
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.
Claims 1, 2, 3, 4, 5, 6, 7, 10, 11, 12, 13, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bunegin (WO 2018/112072).
Regarding Claim 1, Bunegin teaches a perfusion system (Fig. 2) comprising:
a housing (21) containing a head unit configured to circulate a perfusate (pg. 3, col I, 27),
the head unit comprising:
an oxygenator (25) disposed in the housing and configured to oxygenate the perfusate, the oxygenator configured to be fluidly coupled with an oxygen source (40) and configured to receive oxygen therefrom (Fig. 3); and
a perfusion pump disposed in the housing and operably coupled with the oxygenator and configured to circulate the perfusate through the oxygenator (control system 41, valve 42, chamber 2 and pumping diaphragm 24, on pg. 6, I. 7-15 and in Fig. 5);
a cannister releasably coupled to the housing (chamber, 2), the cannister having a receptacle sized and shaped for receiving a target tissue (pg. 7, I. 12-15, and point 8.1);
a cannister pressurization component fluidly coupled with the cannister and configured to maintain pressure in the cannister by acting as a pneumatic spring when pressurized by a gas pressure provided by a cannister pressure regulator ( Housing 21 includes a base plate 17 that flexes upward (e.g. , away from the vascular tissue coupled to outflow channel 15) to accommodate the increased volume of preservation solution 13 flowing into compartment 18. Between the times that pulses of higher pressure enter the chamber 2, the pressure in chamber 2 is reduced by venting oxygen through vent orifice 8 into chamber 9, and through ring orifices 10 of ring 37 into vent chamber 16. The examiner notes that the limitation beginning with “when” is a conditional limitation);
a base plate adjacent the cannister pressurization component, the base plate for connecting the head unit to the cannister (Housing 21 includes a base plate 17); and
a cannula fluidly coupled with the head unit and the target tissue (15), the cannula adjacent the base plate and configured to introduce the perfusate from the head unit to the target tissue in the cannister (pg. 6, I. 12-15).
Regarding Claim 2, Bunegin teaches the system of claim 1, wherein the perfusion pump comprises: a pump chamber for collecting oxygenated perfusate from the oxygenator (2); a valve fluidly coupled to the pump chamber (42), the valve configured to regulate pressure in the pump chamber; and a diaphragm operably coupled with the pump chamber and configured to pressurize the pump chamber (24), the diaphragm configured to circulate the perfusate through the system from the pump chamber to the cannister (the diaphragm is capable of being configured to circulate the perfusate).
Regarding Claim 3, Bunegin teaches the system of claim 2, wherein the valve is fluidly connectable to the oxygen source and the pump diaphragm (valve 42 may be a pneumatic valve, and control system 41 may comprise an electronic circuit that controls valve 42. For example, control system 41 can open valve 42 to admit oxygen through port 1 into chamber 2, and then close valve 42 to allow oxygen from chamber 2 to exhaust through port 8.).
Regarding Claim 4, Bunegin teaches the system of claim 3, wherein the valve (42) comprises at least one moveable element that can move alternately between: a first position, wherein the valve de-pressurizes the diaphragm to allow flow of oxygen from the pump chamber to the oxygenator; and a second position opposite the first position, wherein the valve pressurizes the diaphragm and induces circulation of oxygenated perfusate out of the pump chamber to the cannister via the cannula (see page 6, I. 20-22 and point 8.2).
Regarding Claim 5, Bunegin teaches the system of claim 1, wherein the head unit further comprises a filter fluidly coupled with the oxygenator and configured to filter the perfusate, wherein the oxygenator is configured to receive oxygen-depleted perfusate from the cannister through the filter (In the embodiments described herein, oxygen permeable capillaries of an oxygenator (in combination with a pumping membrane, which may comprise a conical pumping membrane) are integrated to achieve three functions in parallel. The first function is to drive perfusate though the attached limb or other vascular tissue. The second function is to prevent retrograde flow of perfusion fluid though the oxygen permeable capillaries of the oxygenator. The third function is to oxygenate the perfusate.).
Regarding Claim 6, Bunegin teaches the system of claim 1, wherein the oxygenator is configured to receive oxygen-depleted perfusate from the cannister, oxygenate the perfusate, and return the oxygenated perfusate to the target tissue via the cannula (the oxygenator is capable of being configured to receive oxygen-depleted perfusate from the cannister, oxygenate the perfusate, and return the oxygenated perfusate to the target tissue via the cannula).
Regarding Claim 7, Bunegin teaches the system of claim 1, wherein the cannula is configured to be fluidly coupled to the target tissue and configured to support the weight of the target tissue when the target tissue is removed from the cannister (the cannula is capable of being fluidly coupled to the target tissue and configured to support the weight of the target tissue when the target tissue is removed from the cannister).
Regarding Claim 10, Bunegin teaches the system of claim 1, wherein the cannister pressurization component comprises a diaphragm operably coupled with the cannister (see base plate 17 as an elastic diaphragm, p. 7, I. 2-4).
Regarding Claim 11, Bunegin teaches the system of claim 1, wherein the cannister pressurization component is configured to be pressurized by an external pressure source (the pressurization component would be capable of being pressurized by an external pressure source).
Regarding Claim 12, Bunegin teaches the system of claim 1, further comprising an oxygen source fluidly coupled to the head unit to provide the gas pressure (oxygen source 40 in Fig. 3).
Regarding Claim 13, Bunegin teaches the system of claim 12, wherein the cannister pressurization component is fluidly coupled to the oxygen source to allow pressurization thereof (the base plate 17 is pressurized to deflect upward by the oxygen source 40 pressurizing chamber 2 and forcing perfusate from channel 7 into the organ and from the external oxygen source will pressurize the elastic bottom 12 as it forces perfusate from perfusion chamber 54 into storage compartment 23).
Regarding Claim 14, Bunegin teaches the system of claim 1, wherein the cannister pressurization component comprises an expandable and collapsible balloon ([0035]-[0037] means to control cannister pressure).
Regarding Claim 15, Bunegin teaches the system of claim 1, wherein the cannister pressurization component comprises an elastic diaphragm, a spring-coupled diaphragm, or a spring-coupled sliding piston (see base plate 17 as an elastic diaphragm, p. 7, I. 2-4).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Bunegin (WO 2018/112072), in view of Bunegin (US Pub 2011/0212431).
Regarding Claim 8, Bunegin teaches the system of claim 1.
Bunegin is silent to the base plate comprises further comprising a base plate and a sealing element disposed between the cannister and the head unit, the base plate and sealing element forming a fluid tight seal therebetween.
Bunegin (‘431) teaches in the related art of a preservation apparatus. See Abstract. [0040] Support element 5 is shaped to conform to the shape of storage compartment 23. When positioned onto the lip of the storage compartment 23, support element 5 defines a closed storage chamber in which the organ or tissue are sealed. [0049] The preservation apparatus is sealed with lid 1. Lid 1 is shaped to conform to the shape of storage compartment 23. In one embodiment, lid 1 is elliptical and convex when viewing from above. When positioned onto the storage compartment 23, lid 1 hermetically seals the preservation apparatus from the surrounding atmosphere. When assembled with membrane support 3, lid 1 and the membrane support define pumping chamber 52.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a base plate and a sealing element disposed between the cannister and the head unit, the base plate and sealing element forming a fluid tight seal therebetween, as taught by Bunegin (’431), to the device, as taught by Bunegin to allow for hermetically sealing the preservation apparatus from the surrounding atmosphere, as taught by [0049].
Regarding Claim 9, Bunegin teaches the system of claim 1.
Bunegin is silent to an inner lid adjacent the base plate and separating the head unit from the cannister, the inner lid releasably coupled to the cannister, wherein the inner lid comprises a wall defining an aperture therethrough, and wherein the cannula is disposed in the aperture, and wherein the inner lid allows sterile access to the cannister, and wherein the inner lid supports weight of the target tissue.
Bunegin (‘431) teaches in the related art of a preservation apparatus. See Abstract. [0046] In the embodiment depicted in FIG. 1b central member 4c provides an opening to receive sensor housing 2. In an embodiment, a sensor housing 2 may be fitted into central member 4c as depicted in FIG. 1. Sensor housing 2 may include data ports 14 and priming ports 15. Sensor housing may also serve as a support to offset the membrane support from lid 1. When membrane support 4 is placed onto the lip of the support element 5, the membrane support and support element 5 define perfusion chamber 54. The inner lid would be capable of supporting the weight of the target tissue.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an inner lid adjacent the base plate and separating the head unit from the cannister, the inner lid releasably coupled to the cannister, wherein the inner lid comprises a wall defining an aperture therethrough, and wherein the cannula is disposed in the aperture, and wherein the inner lid allows sterile access to the cannister, and wherein the inner lid supports weight of the target tissue, as taught by Bunegin (‘431), in the device of Bunegin, to allow for filling with perfusion fluid, as taught by Bunegin (‘431).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-6.
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/JB/
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798