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 statements (IDS) submitted on 08/30/2024 were filed before the mailing date of the FAOM. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 7 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim includes limitation of the container having “a dividing wall”, which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The limitation “a dividing wall” is currently written as a separate structure from the funnel. However, the specification only discusses “a dividing wall” as partially defined by the filter. Thus, the specification only provides support for “a dividing wall” to be part of the structure of the filter and not a separate structure from the filter (paragraph [0039]).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4, 6-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Jordan (US Pat No. 8,366,694 B1 published 02/05/2013) in view of Cimino et al (US Pat No. 9,909,094 B2 published 03/06/2018; hereinafter Cimino).
Regarding claim 1, Jordan teaches a tissue processing system (a tissue refining device for collecting and processing tissue – column 4 lines 22-23), comprising:
a container (a canister body 22 – Fig. 14), including:
an exterior wall surrounding an interior volume (an interior surface 74 of the canister body 22 – Figs. 2 and 14 ) for holding tissue;
a filter structure (a funnel body 67 – column 7 lines 46-48 and Fig. 14) for processing tissue, the filter structure including a mesh wall (apertures 44 in the funnel body 67 forms a mesh in the suction path to the vacuum pump 32 – column 7 lines 46-48 and Fig. 14) (“mesh wall” is interpreted under BRI as a wall with evenly spaced opening);
a flow management device (a flow path connecting a syringe 54 and a vacuum source 32 – Fig. 16A-D);
a flexible tube (a collection tube 172 – Fig. 16A-D) extending from a port located at a bottom portion (the collection tube 172 extending to a spout 76 – Fig. 16A-D) of the container in fluid communication with an interior portion of the filter structure (the collection tube 172 – Fig. 16A-D); and
a stop mechanism to prevent filling of the container above a maximum fill level (an overflow shutoff valve 110 installed in the lid 62 – Figs. 1 and 8-9), wherein the flexible tube has a length sufficient for a distal end of the tube to be positioned above the stop mechanism (the syringe side end 173 of the collection tube 172 is capable of being positioned above the shutoff valve 110 installed in the lid 62 – Figs. 1 and 16A-B), thereby preventing leakage of fluid from the container through the flexible tube (the syringe side end 173 of the collection tube 172 can be placed above the shutoff valve 11 and prevent leaks from the tube 172 – Fig. 16A-D).
However, Jordan does not teach at least one mixing blade to facilitate tissue washing or treatment, the at least one mixing blade contacting an inner surface of the mesh wall during rotation within the container, thereby cleaning the mesh wall.
Cimino teaches an apparatus for collecting adipose tissue further comprising at least one mixing blade (processing apparatus 100 comprising a blade like mixing members 320 with a filter contact member 376 on a rotating shaft 318 movably contacts the filter – column 5 lines 59-60 and Fig. 15) (the rotating shaft 318 is moved by a handle 382 – Fig. 12 and column 30 lines 50-51) to facilitate tissue washing or treatment (the contact member 376 contacts the filter 312 and causes build up to be dislodged from the mesh filter 312 – column 29 lines 56-57 and column 32 lines 56-58), the at least one mixing blade contacting an inner surface of the mesh wall during rotation within the container, thereby cleaning the mesh wall (the contact member 376 of the mixing members 320 contacts the filter 312 and causes build up to be dislodged from the mesh filter 312 – Cimino column 29 lines 56-57 and column 32 lines 56-58). Cimino teaches that the filter contact member 376 may assist in keeping the filter from clogging and increasing the effectiveness of the filter 312 (column 32 lines 59-60).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device, as taught by Jordan, with the mixing members and filter contact member, taught by Cimino, to use contact member 376 prevent clogging and increase the effectiveness of the filter 312. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Jordan and Cimino teach adipose tissue collecting devices.
Regarding claim 2, Jordan, modified by Cimino, teaches the tissue processing system of claim 1, wherein the stop mechanism comprises a valve (an overflow shutoff valve 110 installed in the lid 62 – Figs. 2 and 8-9).
Regarding claim 4, Jordan, modified by Cimino, teaches the tissue processing system of claim 2, wherein the stop mechanism consists of at least one of a butterfly valve, a fill valve (an overflow shutoff valve 110 is a fill valve formed by enlarged base 126 and a central tube 128 – Figs. 9-10 and column 9 lines 25-27), and a diaphragm valve.
Regarding claim 5, Jordan, modified by Cimino, teaches the tissue processing system of claim 1, wherein the distal end of the flexible tube comprises a flip cap (the distal end of the tubing comprising a pinch clamp 174 capable of flipping between opened and close position and functions as a cap – Figs. 16A-D).
Regarding claim 6, Jordan, modified by Cimino, teaches the tissue processing system of claim 1, wherein the flexible tube is positioned such that the distal end of the flexible tube is positioned above a maximum harvest level (the syringe 54 is connected to a flexible harvesting tube 172 and is capable of being positioned above a maximum harvest level – Fig. 16C and column 12 lines 24-26).
Regarding claims 7 and 9, Jordan, modified by Cimino, teaches the tissue processing system of claim 1, wherein the container includes a first chamber (an upper vacuum chamber 40 – Fig. 11) and a second chamber (a lower vacuum chamber 42 – Fig. 11) divided by a dividing wall (a funnel 38 divides the upper vacuum chamber 40 and the lower vacuum chamber 42 – Fig. 11), and the tissue processing system of claim 7, wherein the dividing wall is defined at least in part by the filter structure (the funnel 38 is defined in part by the funnel body 67 – Fig. 14).
Regarding claim 8, Jordan, modified by Cimino, teaches the tissue processing system of claim 7, further comprising an opening in the first chamber (an evacuation tube 107 – Fig. 11) that provides a conduit between the first chamber and the second chamber (the evacuation tube 107 is capable of providing a conduit between the upper vacuum chamber 40 and the lower vacuum chamber 42 – Fig. 11).
Regarding claim 10, Jordan, modified by Cimino, teaches the tissue processing system of claim 1, wherein the filter structure includes a frame supporting an outer surface of the mesh wall (a cylindrically shaped sidewall 56 supporting an outer surface of the funnel body 67 – Fig. 11).
Regarding claim 11, Jordan, modified by Cimino, teaches the tissue processing system of claim 10, wherein the frame supporting the mesh wall comprises a rigid material (the sidewall 56 are made from rigid plastics – column 11 lines 19-24).
Regarding claim 12, Jordan, modified by Cimino, teaches the tissue processing system of claim 10, wherein the frame comprises a rigid material (the sidewall 56 are made from rigid plastics – column 11 lines 19-24) surrounding an upper border of the mesh wall (the sidewall 56 surrounding an upper border of the funnel body 67 – Fig. 14) and the frame extends along at least a portion of a side wall of the mesh wall to a bottom portion of the mesh wall (the sidewalls 56 extends down to the lower point 80 of the funnel body 67 – Fig. 14).
Regarding claim 13, Jordan, modified by Cimino, teaches the tissue processing system of claim 1, further comprising a rotatable handle operably connected to the at least one mixing blade (Jordan, modified by Cimino, teaches a handle 382 spins the rotating shaft 318 holding the mixing members 320 – Cimino Fig. 12 and column 30 lines 50-51).
Regarding claim 14, Jordan, modified by Cimino, teaches the tissue processing system of claim 1, further comprising a plurality of openings (vacuum port 24, fluid evacuation port 26, and tissue harvesting port 28 – Fig. 5) and tubes (fluid evacuation tube 86, tubing 164, and tubing 178 – Figs. 5 and 16A) to facilitate tissue and fluid transfer throughout the tissue processing system (vacuum port 24, fluid evacuation port 26, tissue harvesting port 28, fluid evacuation tube 86, tubing 164, and tubing 178 are capable of being used for tissue and fluid transfer – Fig. 5).
Regarding claim 16, Jordan, modified by Cimino, teaches the tissue processing system of claim 1, wherein the proximal end of the flexible tube (an opposing spout side end 175 of the adipose tissue collection tube 172 – Fig. 16A-D) is in fluid communication with the interior volume via a port (the opposing spout side end 175 is connected to a projecting spout 76 leading into the tissue refining device – Fig. 15).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Jordan, modified by Cimino, in view of Sparks et al (US20170304823A1 published 10/26/2017; hereinafter Sparks).
Regarding claim 3, Jordan, modified by Cimino, teaches the tissue processing system of claim 2.
However, Jordan, modified by Cimino, does not teach wherein the stop mechanism comprises a ball valve.
Sparks teaches a centrifuge tube wherein the stop mechanism comprises a ball valve (a buoy 501 comprising a ball and spring check valve 508 – paragraph 19 and Fig. 5A-F). Sparks teaches to use a ball and spring check valve to allow the separation of multi-component liquid sample (paragraph 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the overflow shutoff valve of the tissue refining device, as taught by Jordan as modified by Cimino, with the ball and spring check valve, taught by Sparks, to allow the separation of multi-component liquid sample. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because both Jordan, Cimino, Sparks teach tissue processing devices.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Jordan, modified by Cimino, in view of Friedman et al (US20170112981A1 published 04/27/2017; hereinafter Friedman).
Regarding claim 15, Jordan, modified by Cimino, teaches the tissue processing system of claim 1, wherein the flow management device (a flow path connecting a syringe 54 and a vacuum source 32 – Fig. 16A-D) comprises:
a first plate (a lid 158 of the waste canister 52 – Figs. 16A-D) having a plurality of first openings passing therethrough (downstream vacuum port 160 and upstream vacuum port 162 – Figs. 16A-D);
a second plate (a funnel 38 with a funnel body 67 – Fig. 2) having a plurality of second openings (multiple apertures 44 in the funnel body 67 – Fig. 2) passing therethrough; and
a third plate (a lid 62 with vacuum manifold 140 – Fig. 12) having one or more third openings passing therethrough (vacuum port 24, evacuation port 26, and tissue harvesting port 28 – column 8 lines 53-54);
wherein the first plate, second plate, and third plate are operably connected (the connections are made using tubing or conduit 178 and tubing 164 – Figs. 16A-D and column 10 lines 40-43) and
wherein setting the third plate in a first position (the evacuation port 26 connected to a reciprocal drain valve 156 in the open position B – Fig. 16B and column 14 lines 46-47) places a first subset of the plurality of first openings in fluid communication with a first subset of the plurality of second opening (when the reciprocal drain valve 156 is opened (position B) the upstream vacuum port 162 is in fluid communication with one of the apertures 44 – Fig. 16B and column 14 lines 46-47).
However, Jordan, modified by Cimino, does not teach wherein setting the third plate in a second position places a second subset of the plurality of first openings in fluid communication with a second subset of the plurality of second openings, and setting the third plate to a third position places a third subset of the plurality of first openings in fluid communication with a third subset of the plurality of second openings.
Freidman teaches a tissue treatment system 100 comprising a tube management device 101 having a multi-position switch 103 with three positions wherein setting the third plate (a tube restrictor plate 104 with restrictor elements 105A, 105B, 105C – Fig. 2) in a first position places a first subset of the plurality of first openings (a plate with ports 102A, 102B, 102C – Fig. 2) in fluid communication with a first subset of the plurality of second opening (support plate 107 with slots 115A, 115B, 115C – Fig. 3 and paragraph 58) (tube restrictor plate 104 has an open restrictor element 105C and connects port 102C with slot 115C – Fig. 3), setting the third plate in a second position places a second subset of the plurality of first openings in fluid communication with a second subset of the plurality of second openings (rotating tube restrictor plate 104 opens restrictor elements 105A and 105B and connects port 102A and 102B with slot 115A and 115B – Fig. 3), and setting the third plate to a third position places a third subset of the plurality of first openings in fluid communication with a third subset of the plurality of second openings (rotating tube restrictor plate 104 opens restrictor elements 105B and 105C and connects port 102B and 102C with slot 115B and 115C – Fig. 3). Friedman teaches to use the tube management device 101 to disconnect vacuum pressure during processing and block unused flow path to maintain the sterility of the system (paragraphs 51-52).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the lid 62, as taught by Jordan as modified by Cimino, with the tube management device, taught by Friedman, to disconnect vacuum pressure during processing and maintain sterility. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because both Jordan, Cimino, and Friedman all teach adipose tissue processing devices.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Jordan, modified by Cimino, in view of Apfel (US Pat No. 8,871,159 B1 published 10/28/2014)
Regarding claim 17, Jordan, modified by Cimino, teaches the tissue processing system of claim 1.
However, Jordan, modified by Cimino, does not teach wherein the filter structure comprises a hexagonally shaped cross-section.
Apfel teaches two-stage filter device to retrieve tissue fragments and cell aggregates wherein the filter structure comprises a hexagonally shaped cross-section (a hexagonal first container 1 comprising a first plurality of pores 7 and a hexagonal second container 2 comprising a second plurality of pores 8 – Fig. 2D and column 4 lines 35-36). Apfel teaches that the first plurality of pores 7 and second plurality of pores 8 are different sizes to separate single cells 16 and cell aggregates 17 (Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the filter structure, as taught by Jordan as modified by Cimino, with the hexagonal two-stage filter device, as taught by Apfel, to separate single cells 16 and cell aggregates 17. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Jordan, Cimino, and Apfel teach tissue separation devices.
Conclusion
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/T.C.S./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796