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 .
Claim Objections
The claims contain minor informalities.
In claim 1, the language “… and collect the concentrated adipose tissue from the outlet of the adipose separation module …” should be changed for clarity.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 25, 39, 43, 48, 62, 71, 74-75, 80-81 and 146 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 12 calls for “…the orifice of the fat separation module, when present, being fluidly connected to the first compartment…” There is insufficient antecedent basis for these limitations in the claim. Although parent claim 1 describes an adipose separation module, neither parent claim 1 nor claim 12 describes an “orifice” or “fat separation module.”
Claims 39, 43, 48, 62, 71, 74-75, 80-81 and 146 are rejected for depending on a rejected parent claim.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1, 6, 167, 175, 179, 182, 204 and 207 are rejected under 35 U.S.C. 103 as being unpatentable over Hedrick; Marc H. et al. (US 20100233139 A1) in view of Wells; John F. et al. (US 20170304509 A1).
Regarding claim 1, Hedrick discloses a kit of consumable parts for a closed-loop adipose transplant system (¶ [0003], [0011], devices, systems and methods for preparing adult regenerative cells from adipose tissue);
including a liposuction cannula and a first tube (¶ [0064], For example, adipose tissue may be removed from a patient by liposuction (syringe or power assisted) or by lipectomy … or combinations thereof);
a first pump (¶ [0064], adipose tissue may be removed from a patient by liposuction (syringe or power assisted) or by lipectomy, e.g., suction-assisted lipoplasty);
a second pump (¶ [0070], peristaltic pumps 34 or positive displacement pumps (not shown); ¶ [0085], applying positive or negative pressure, by use of pumps 34 or by use of vents 32); and
an injector (¶ [0170] In breast augmentation procedures, the route of delivery may include open delivery through a standard 14-guage blunt tip cannula … In soft tissue augmentation procedures, the route of delivery may include open delivery through a standard 14-guage blunt tip cannula … In urinary incontinence procedures, the route of delivery may include direct injection at the bladder neck and proximal urethra through cystoscopic visualization);
the kit comprising: a collection canister (¶ [0074], The aspirated tissue is transferred to the collection chamber 20 via a conduit such as 12a; ¶ [0075] The collection chamber 20 may be comprised of a plurality of flexible or rigid canisters or cylinders or combinations thereof);
a second tube (¶ [0082], conduit 12d);
an adipose separation module having an inlet and an outlet (¶ [0068], processing chamber 30);
a collection reservoir (¶ [0068], tissue collection chamber 20);
a third tube (Fig. 3, a tube connects between pump 34 and output bag 50); and
a fourth tube (¶ [0170] In breast augmentation procedures, the route of delivery may include open delivery through a standard 14-guage blunt tip cannula … In soft tissue augmentation procedures, the route of delivery may include open delivery through a standard 14-guage blunt tip cannula … In urinary incontinence procedures, the route of delivery may include direct injection at the bladder neck and proximal urethra through cystoscopic visualization);
wherein the second tube is configured to fluidly connect the collection canister to the inlet of the adipose separation module (Fig. 3, conduit 12d connects collection chamber 20 to processing chamber 30);
wherein the third tube is configured to fluidly connect the outlet of the adipose separation module to the collection reservoir (Fig. 3, a tube connects between pump 34 and output bag 50);
wherein the fourth tube is configured to fluidly connect the collection reservoir to the injector (¶ [0170] In breast augmentation procedures, the route of delivery may include open delivery through a standard 14-guage blunt tip cannula … In soft tissue augmentation procedures, the route of delivery may include open delivery through a standard 14-guage blunt tip cannula … In urinary incontinence procedures, the route of delivery may include direct injection at the bladder neck and proximal urethra through cystoscopic visualization);
wherein the collection canister is configured to receive and collect a mixture comprising adipose tissue harvested from a first anatomical region by the liposuction cannula via the first tube (¶ [0074], The aspirated tissue is transferred to the collection chamber 20 via a conduit such as 12a where it is rinsed and digested; ¶ [0080] An exemplary collection chamber 20 of the system, illustrated in FIG. 5, is comprised of a vacuum line 11 which may be used to evacuate air from the chamber which allows the user to remove tissue with a user supplied cannula);
wherein the adipose separation module is configured to: receive the mixture from the collection canister through the inlet and separate the adipose tissue from the mixture, thereby concentrating the adipose tissue from the mixture (¶ [0094], However, in other embodiments, a portion of the regenerative cell composition is directed to the processing chamber 30, and another portion is directed to a different region of the system, e.g., the sample chamber 60, to be recombined with cells processed in the processing chamber 30 at a later time; ¶ [0095], the processing chamber 30 may be similar to the processing chamber disclosed in commonly owned U.S. application Ser. No. 10/316,127, filed Dec. 7, 2001 and U.S. application Ser. No. 10/325,728, filed Dec. 20, 2002, the contents of which in their entirety are hereby incorporated by reference; ¶ [0096], The filters 36 present in the processing chamber 30 may allow for separation and concentration of a particular subpopulation of regenerative cells, e.g., stem cells or endothelial progenitors cells etc.; ¶ [0103] The thrice-filtered regenerative cell composition (i.e., the composition remaining after being passed through the first, second, and third filters) may then be directed to multiple outlets, which may include a portion of the processing chamber 30 comprising multiple outlets);
wherein the collection reservoir is configured to receive and collect the concentrated adipose tissue from outlet of the adipose separation module via the third tube (¶ [0112], With the vent 32 open, a pump, such as the pump 34, can function to transfer the concentrated regenerative cells into the output bag … In a sterile fashion, the fitting on the output bag may be attached to the outlet port, and the concentrated regenerative cells may be transferred to the output bag); and
wherein the second tube is configured to fluidly connect the first pump to the collection canister and the adipose separation module, such that the second tube communicates a pressure applied by the first pump; the pressure being sufficient to: transport the mixture through the second tube from the collection canister to the inlet of the adipose separation module (¶ [0113] As illustrated in FIGS. 1-3, a vacuum pump 26 may be provided in the system 10 to change the pressure in the system, among other things. For example, the vacuum pump 26 may be coupled to the collection chamber 20 via a conduit, such as conduit 12b, to cause a decrease in pressure within the collection chamber 20. Vacuum pump 26 may also be coupled to the processing chamber 30 by way of a conduit, such as conduit 12g; ¶ [0114] With reference to FIGS. 10 and 11, the pressure generated by the vacuum pump 26 can be used to direct the flow of fluids, including the regenerative cells, through the conduits 12. This pressure can be supplied in multiple directions, for example, by automatically or manually controlling the position of one or more valves 14 in the system 10);
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wherein the consumable parts together form a continuous, closed fluid pathway for the adipose tissue from the liposuction cannula to the collection canister through the first tube, from the collection canister to the inlet of the adipose separation module through the second tube, from the inlet to the outlet through the adipose separation module, from the outlet of the adipose separation module to the collection reservoir through the third tube, and from the collection reservoir to the injector through the fourth tube (¶ [0170] In breast augmentation procedures, the route of delivery may include open delivery through a standard 14-guage blunt tip cannula … In soft tissue augmentation procedures, the route of delivery may include open delivery through a standard 14-guage blunt tip cannula … In urinary incontinence procedures, the route of delivery may include direct injection at the bladder neck and proximal urethra through cystoscopic visualization).
Regarding the claimed fourth tube, Hedrick calls for injecting autologous adipose tissue during various procedures through a cannula (¶ [0011], Accordingly, the present invention provides methods of augmenting fat transfer, e.g., autologous fat transfer; ¶ [0162], Examples of soft tissue augmentation procedures include, but are not limited to: contour deformities of the face … retro-orbital, and plantar fat pad; ¶ [0170], a standard 14-guage blunt tip cannula). This suggests that Hedrick’s system connects a tube between the output bag 50 and reinjection cannula.
Hedrick teaches the invention substantially as claimed by Applicant but does not configure the fourth tube to connect the second pump to the collection reservoir and the injector, such that the fourth tube communicates a pressure applied by the second pump. Wells discloses an adipose tissue (AT) transfer system (¶ [0006], [0010], 0046] FIG. 1A provides a schematic diagram of a system of the invention … a harvesting and reinjection system (transfer system) 100);
wherein a fourth tube is configured to fluidly connect a pump to a collection reservoir and an injector, such that the fourth tube communicates a pressure applied by the pump (¶ [0046], reinjection pump 108);
the pressure being sufficient to: transport the concentrated adipose through the fourth tube from the collection reservoir to the injector and inject adipose tissue into an anatomical region (¶ [0067], While one of the outputs of the dual output port 202 is used to drain away the undesired (auxiliary) aspirated material, the other of the outputs is connected to flexible tubing 118, which is run through the reinjection pump 108 and is eventually connected to the reinjection cannula 110; ¶ [0076] FIG. 4 shows a cross-sectional view of the peristaltic pump head 304 with the flexible tubing 118 installed. The peristaltic pump uses positive displacement to move material through the pump).
Wells finely controls a fluid pressure of adipose tissue while reinjecting it in a patient (¶ [0071], The reinjection pump 108, utilized in the system 100 according to the idea of the current invention, is configured to maximize the flow rate of the adipose tissue, while at the same time controlling and adjusting the positive pressure levels in the tubing 118, the reinjection cannula 110, and the injection site 120 in real-time; ¶ [0083], The reason for actively controlling … there is an actual limit on the flow of the adipose tissue through the flexible tubing 118 and the reinjection cannula 110). One would be motivated to modify Hedrick with Wells’s fourth tube and second pump configuration to more accurately control pressures while reinjecting adipose tissue since Hedrick calls for reinjecting adipose into sensitive or small target locations (¶ [0170]). Therefore, it would have been obvious to modify Hedrick with Wells’s fourth tube and second pump configuration in order to maintain safe pressures while reinjecting adipose tissue.
Regarding claims 6, 175, 179 and 204, Hedrick discloses a kit wherein the adipose separation module is further configured to contact the mixture with a wash liquid, thereby washing the mixture, and to separate the adipose tissue from the mixture and the wash liquid, thereby concentrating the adipose tissue (¶ [0074] As set forth herein, tissue may be extracted from a patient via any art recognized method. The aspirated tissue is transferred to the collection chamber 20 via a conduit such as 12a where it is rinsed and digested; ¶ [0075], The collection chamber 20 may also be comprised of one or more flexible bags … The collection chamber 20 is sized to hold the requisite amount of saline to appropriately rinse and digest the tissue prior to the wash and concentrate stage of the process performed in the processing chamber 30);
wherein the kit further comprises: a first volume sensor configured to be connected to the collection canister and to detect the volume of the mixture within the collection canister (¶ [0076], In other embodiments, the volume of tissue and/or fluid in the collection chamber 20 is determined by automated sensors 29 … In a preferred embodiment, the system senses the volume within the collection chamber with an accuracy of plus or minus fifteen percent);
a second volume sensor configured to be connected to the collection reservoir and to detect the volume of the concentrated adipose tissue within the collection reservoir; or a combination thereof (¶ [0070], The conduits 12 and/or the valves 14 may also be comprised of sensors 29, e.g., optical sensors, ultrasonic sensors, pressure sensors or other forms of monitors known in the art that are capable of distinguishing among the various fluid components and fluid levels that flow through the system.; ¶ [0132], In addition, sensors, such as pressure sensor 29, may be provided in line with the processing chamber 30 and the collection chamber 36);
wherein the kit further comprises the injector (¶ [0170] In breast augmentation procedures, the route of delivery may include open delivery through a standard 14-guage blunt tip cannula … In soft tissue augmentation procedures, the route of delivery may include open delivery through a standard 14-guage blunt tip cannula … In urinary incontinence procedures, the route of delivery may include direct injection at the bladder neck and proximal urethra);
wherein the injector is configured to receive the concentrated adipose tissue from the collection reservoir via the fourth tube and inject the concentrated adipose tissue into the second anatomical region (Fig. 4 shows arrows leading from the centrifuge output to the patient; ¶ [0149] The disposable sets may further comprise one or more needles or syringes suitable for obtaining adipose or other tissue from the patient and returning regenerative cells to the patient);
a method of use of the kit of claim 1, the method comprising transplanting adipose tissue from the first anatomical region to the second anatomical region using the kit (¶ [0170] In breast augmentation procedures … In soft tissue augmentation procedures … In urinary incontinence procedures).
Regarding claim 167, Hedrick discloses that the kit further comprises: a second pressure sensor configured to be fluidly connected to the second tube between the first pump and the adipose separation module, wherein the second pressure sensor is configured to detect the pressure between the first pump and the adipose separation module (¶ [0132], In addition, sensors, such as pressure sensor 29, may be provided in line with the processing chamber 30 and the collection chamber 36).
This claim calls for first, second, third and fourth pressure sensors, “or a combination thereof.” Hedrick discloses at least two pressure sensors 29 and 39. In Fig. 4, Hedrick depicts multiple locations for sensor 29. Therefore, Hedrick meets the description of this claim.
Regarding claim 182, Hedrick discloses an injector (¶ [0170] In breast augmentation procedures, the route of delivery may include open delivery through a standard 14-guage blunt tip cannula … In soft tissue augmentation procedures, the route of delivery may include open delivery through a standard 14-guage blunt tip cannula … In urinary incontinence procedures, the route of delivery may include direct injection at the bladder neck and proximal urethra through cystoscopic visualization).
Hedrick does not explicitly disclose a fifth pressure sensor. Wells discloses an injector configured to be fluidly connected to a fifth pressure sensor, wherein the fifth pressure sensor is configured to detect the pressure at which the injector injects the concentrated adipose tissue into the second anatomical region (¶ [0073] Referring now to FIG. 3, the reinjection pump 108 includes … an external pressure sensor 306; ¶ [0075], The external pressure sensor 306 is configured to monitor the internal pressure in the inner lumen 314 of the flexible tubing 118 … The external pressure sensor 306 may be connected to the housing 302 or may be a free-standing device that provides the reinjection pump 108 with the necessary feedback of internal pressure).
Wells prevents an injector from delivering unsafe pressures, and allows a physician to focus on other surgical tasks (¶ [0084], If the external pressure sensor 306 detects a pressure that exceeds this pressure limit, the programmable processor is programmed to stop the motor and to reverse the pumping direction until the internal pressure is reduced to near zero … The observation of the pressure limit with the use of the external pressure sensor 306 automatically limits the pressure in the tubing 118, and allows the clinician to focus on more important matters, such as placement of reinjected tissue). One would be motivated to modify Hedrick with Wells’s fifth pressure sensor to automatically monitor and limit the pressure at the injector. Therefore, it would have been obvious to modify Hedrick with Wells’s fifth pressure sensor in order to safely deliver adipose to a second anatomical region.
Regarding claim 207, Hedrick discloses a controller for a closed-loop adipose transplant system, wherein the controller is configured to be communicatively coupled to one or more components of the kit of claim 1 (¶ [0144] The partial and fully automated systems may include a processing device (e.g., microprocessor or personal computer) and associated software programs that provide the control logic for the system to operate and to automate one or more steps of the process based on the user's selection);
the controller comprising: a user interface comprising a display (¶ [0144] microprocessor or personal computer; ¶ [0147], In other embodiments, the system is a single integrated system that displays instructions to guide the user to perform predetermined operations at predetermined times);
showing real-time operating parameters and a control selection panel (¶ [0143], The automated systems of the invention provide screen displays (see FIG. 16) that prompt proper operation of the system … The screen may also indicate problems or failures in the system if they occur and provide "troubleshooting" guidance if appropriate);
Hedrick does not explicitly disclose a display showing real-time operating parameters and a control selection panel. Wells discloses a controller for a closed-loop adipose transplant system; the controller comprising: a user interface comprising a display (¶ [0006], a method and system for controlling and adjusting both the levels of tissue-reinjection pressure and tissue-flow rates in real-time; ¶ [0073], The housing 302 is dimensioned to enclose all of the electrical and control components of the reinjection pump 108, the operation of which may be controlled or governed via a touchscreen 308);
showing real-time operating parameters and a control selection panel (¶ [0074], The touch screen 308 allows a user to set variables and settings of the operation of the reinjection pump 108);
wherein the real-time operating parameters comprise: the volume detected by the first volume sensor, the pressure detected by the first pressure sensor, the pressure detected by the second pressure sensor, the pressure detected by the third pressure sensor, the pressure detected by the fourth pressure sensor, the volume detected by the second volume sensor, the pressure detected by the fifth pressure sensor, or a combination thereof (¶ [0071] Therefore, judicious real-time control and adjustment of both flow rates and pressures; ¶ [0075], The external pressure sensor 306 is configured to monitor the internal pressure in the inner lumen 314 of the flexible tubing 118, as shown in the blown-up portion of FIG. 3. The value of measured internal pressure in the inner lumen 314 is transmitted to the control component(s) of the reinjection pump 108, for example, in a form of an electrical signal);
wherein the control selection panel displays control parameters and includes: a selector for starting and stopping an adipose transplant procedure upon selection by a user; and one or more selectors for allowing the user to modify one or more of the control parameters (¶ [0073], The housing 302 is dimensioned to enclose all of the electrical and control components of the reinjection pump 108, the operation of which may be controlled or governed via a touchscreen 308);
wherein the control parameters comprise: a minimum volume for the first volume sensor, a maximum volume for the first volume sensor, a minimum pressure for the first pressure sensor, a maximum pressure for the first pressure sensor, a minimum pressure for the second pressure sensor, a maximum pressure for the second pressure sensor, a minimum pressure for the third pressure sensor, a maximum pressure for the third pressure sensor, a minimum pressure for the fourth pressure sensor, a maximum pressure for the fourth pressure sensor, a minimum volume for the second volume sensor, a maximum volume for the second volume sensor, or a combination thereof (¶ [0074], The touch screen 308 allows a user to set variables and settings of the operation of the reinjection pump 108. For example, possible settings may include the revolutions per minute of a DC motor of the pump 108, a desired limit of the pressure created in the reinjection channel between the pump 108 and the site 120, or a number of pulses per minute for the pulse-mode of reinjecting the adipose tissue; ¶ [0083] The controllable settings of the reinjection pump 108 allow a user to maximize the flow rate of the adipose tissue, while at the same time controlling the positive pressure levels in the tubing 118, the reinjection cannula 110, and the injection site 120. The setting for revolutions per minute (RPMs) is referred hereafter as the speed of the motor and relates to the revolutions per minute of the rollers (shown as 402A, 402B, 402C in FIG. 4) of the peristaltic pump head 304).
Wells describes how to automatically control an adipose processing system with a touchscreen. One would be motivated to modify Hedrick with Wells’s display and its various panels since Hedrick calls for controlling the system with a touchscreen (¶ [0143], In one embodiment, the screen that allows the user to interface with the system is a touch screen). Therefore, it would have been obvious to modify Hedrick with Wells’s display and control panels in order to operate an adipose processing system with a touchscreen.
Claims 12, 25, 43, 48, 71, 74, 75, 80, 81 and 146 are rejected under 35 U.S.C. 103 as being unpatentable over Hedrick and Wells in view of Wang; Kai-Roy et al. (US 20160244722 A1).
Regarding claim 12, Hedrick discloses an adipose separation module (¶ [0068], processing chamber 30).
Hedrick and Wells do not explicitly disclose whether the adipose separation module further comprises a filter and first and second compartments. Wang discloses a tissue processing device for adipose tissue, comprising an adipose separation module (¶ [0002], [0003], [0007], [0035], FIGS. 1-4, various embodiments of an exemplary tissue processing device 100; ¶ [0053], FIG. 5, a diagrammatic view of an exemplary tissue processing system 200);
wherein the adipose separation module further comprises: a housing defining an interior cavity (¶ [0038] The interior of the body 102 includes a hollow space or cavity 118 formed therein);
an inlet (¶ [0047] The first compartment 120 can include one or more collection ports 146, e.g., adipose collection ports, openings, or the like, for introduction of the biological material into the first compartment 120); and
an outlet (¶ [0051] The first compartment 120 includes one or more extrusion ports 150, e.g., extraction openings, removal openings, withdrawal openings, or the like);
a filter configured to be disposed within the interior cavity (¶ [0038], the first and second compartments 120, 122 can be separated by a filter 154);
such that the filter is configured to define a first compartment and a second compartment within the interior cavity, the first compartment being a portion of the interior cavity encompassed by the filter (¶ [0039] The first compartment 120 can be configured and dimensioned to rotatably receive therein an auger 128, e.g., an auger pump, a rotary transfer device, a mechanical transfer device, or the like); and
the second compartment being a portion of the interior cavity outside the filter (¶ [0038], a second compartment 122);
the first compartment having a proximal end and a distal end; the inlet of the adipose separation module being fluidly connected to the first compartment at or near the proximal end of the first compartment (¶ [0047] The first compartment 120 can include one or more collection ports 146, e.g., adipose collection ports, openings, or the like, for introduction of the biological material into the first compartment 120);
the outlet of the adipose separation module being fluidly connected to the first compartment at or near the distal end of the first compartment (¶ [0051] The first compartment 120 includes one or more extrusion ports 150, e.g., extraction openings, removal openings, withdrawal openings, or the like);
the orifice of the fat separation module, when present, being fluidly connected to the first compartment (¶ [0047] The first compartment 120 can include one or more collection ports 146, e.g., adipose collection ports, openings, or the like, for introduction of the biological material into the first compartment 120);
the filter being configured to separate the adipose tissue from the wash liquid (when present) and other components in the mixture by passing the wash liquid (when present) and the other components from the mixture through the filter into the second compartment as the mixture is transported through the housing, thereby concentrating the adipose tissue within the first compartment (¶ [0048] The first compartment 120 further includes one or more injection ports 148, e.g., openings, for introduction of a wash solution into the first compartment 120; ¶ [0051], the extrusion ports 150 can be used to fluidically connect the first compartment 120 to an injection device, e.g., a syringe or cannula, and fill the injection device with adipose tissue within the first compartment 120; ¶ [0063], The cleaned adipose tissue can be passed along the auger 128 up to the inner area of the first compartment 120 adjacent to the rear surface 126 … the cleaned adipose tissue can be extruded from the port 150 to fill an attached injection device, e.g., a syringe); and
forming an effluent in the second compartment, the effluent comprising the wash liquid (when present) and the other components from the mixture (¶ [0065] The second compartment 122 containing, e.g., waste, blood, undesired components, combinations thereof, or the like, can be cleaned by connecting a vacuum source, a wash/waste canister, or both, to the port 152).
Wang describes how to wash and separate adipose from a harvested tissue sample (¶ [0059], The harvested adipose tissue can be introduced at a proximal end of the tissue processing device 100 through the port 146; ¶ [0061] The auger 128 can be adapted to serve as a low-shear mechanism for processing and transportation of the adipose tissue from harvest to transplantation). One would be motivated to modify Hedrick and Wells with Wang’s filter and compartments to separate and purify adipose tissue since Hedrick calls for harvesting, purifying and transplanting adipose tissue (¶ [0003], systems for preparing and using adipose-derived regenerative cells which are used to augment fat transfer; ¶ [0162], autologous fat transplantation with the cell-enhanced adipose tissue disclosed herein). Wang describes details of an adipose separation module that achieves these ends. Therefore, it would have been obvious to modify Hedrick and Wells with Wang’s filter and compartments in order to construct an adipose separation module as required by Hedrick.
Regarding claims 25, 43, 71 and 74, Hedrick and Wells lack compartments and a rotary implement. Wang discloses that the first compartment is disposed coaxially with the filter (¶ [0038], the first and second compartments 120, 122 can be separated by a filter 154. The first compartment 120 can define a substantially cylindrical configuration);
wherein the adipose separation module further comprises: a rotary implement having a proximal end and a distal end, the rotary implement comprising a central shaft and a blade extending from the central shaft (¶ [0039], The auger 128 includes a shaft 130 extending between the front and rear surfaces 124, 126 of the body 102; ¶ [0044] The auger 128 further includes a second section 142 at a portion distal to the front surface 124 including a helical blade(s) 144, e.g., a helical screw blade(s), a rotating screw(s), or the like);
wherein the filter is configured to be disposed circumferentially around and coaxially with the rotary implement within the interior cavity, such that the rotary implement is configured to be rotatably disposed within the first compartment with the proximal end of the rotary implement disposed towards the proximal end of the first compartment and the distal end of the rotary implement being disposed towards the distal end of the first compartment (¶ [0046], For example, the filter 154 can separate the blade 144 and/or the catchers 140 (or both) from the second compartment 122 along the bottom of the first compartment 120); and
wherein the rotary implement is configured to agitate the mixture within the first compartment via rotation of the rotary implement (¶ [0059], For example, during rotation of the auger 128, the blades 144 can push the adipose tissue along the length of the first compartment 120 up to the inner portion of the rear surface 128; ¶ [0062], In particular, rotation of the auger 128 can mechanically transport the adipose tissue through and along the auger 128 from the proximal end to the distal end of the tissue processing device 100);
wherein the adipose separation module further comprises a port defined by the housing, the port being fluidly connected to the second compartment; wherein the kit further comprises a sixth tube and an effluent receptacle, wherein the sixth tube is configured to fluidly connect the port of the adipose separation module to the effluent receptacle, the effluent receptacle being configured to receive the effluent from the port of the adipose separation module (¶ [0052], the second compartment 122 can include one or more ports 152 … The ports 152 can be a vacuum port which connects to a wash and/or waste canister and a vacuum source for cleaning the second compartment 122).
Regarding claim 48, Hedrick and Wells do not explicitly disclose a rotary implement or filter. Wang discloses that the blade of the rotary implement has an edge, and wherein the edge and the filter are radially spaced apart from each other (¶ [0045], the characteristics can be, e.g., the shape of the blade 144, the size of the blade 144, the seal or spacing between the auger 128 and the inner walls of the first compartment 120 such that slip of the biological material is prevented or reduced … or the like).
Hedrick, Wells and Wang are silent whether the blade and filter are separated by a distance of from 0 μm to 2 mm. The blade-filter spacing is interpreted as a result-effective variable, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation. The blade-filter spacing affects the separator’s efficiency and specificity through routine experimentation.
Too small
The blade and filter will strike each other, increase friction and reduce the separator’s efficiency
Optimized gap
The blade and filter will avoid striking, while removing adequate fluids from adipose tissue before it reaches the outlet
Too wide
Adipose or other tissue will sneak through the gap and reach the outlet without adequate processing
Therefore, it would have been obvious to adjust the blade-filter spacing in order to avoid excessive friction while adequately processing the adipose tissue. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 75, 80, 81 and 146, Hedrick discloses a waste collection container configured to receive the effluent from the port of the adipose separation module (¶ [0068], waste chamber 40).
Hedrick and Wells lack an effluent separation module. Wang discloses an adipose separation module as discussed for claim 12 above (¶ [0036] The tissue processing device 100 includes a body 102).
These claims reiterate the structures of the adipose separation module as an effluent separation module. Wang’s adipose separation module includes the same features as the claimed effluent separation module, namely a membrane filter that defines first and second compartments (¶ [0038], the first and second compartments 120, 122 can be separated by a filter 154).
These claims appear to duplicate the adipose separation module as an effluent separation module. A skilled artisan would have been able to modify Hedrick and Wells with Wang’s adipose or effluent separation module by duplicating Wang’s processing device 100 so that it processes the effluent from Hedrick’s waste chamber 40. For example, Hedrick calls for rerouting effluent from waste chamber 40 back to other portions of the circuit (Figs. 2, 10 and 11 show a line connecting the waste chamber 40 to collection chamber 20). Installing a second separator that processes effluent will enable the system to recover further cells or tissues from the supernatant instead of wholly discarding it. Therefore, it would have been obvious to duplicate Wang’s separator as an effluent separation module in order to recover more cells or tissues.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Hedrick, Wells and Wang in view of Friedman; Evan et al. (US 20170112981 A1).
Regarding claim 39, Hedrick, Wells and Wang lack a filter cage. Friedman discloses a tissue treatment system for adipose tissue (¶ [0005], [0010], [0048], [0052], FIG. 1 … tissue treatment system 100);
comprising an adipose separation module (¶ [0137] FIGS. 17A and 17B illustrate a disassembled and assembled filter structure 1810);
wherein the adipose separation module further comprises a filter cage disposed circumferentially around and coaxially with a filter (¶ [0137], The filter structure 1810 can include a frame member 1850 and a filter 1815; ¶ [0141], FIGS. 17A-17B, the filter structure can divide first and second portions or chambers of the tissue treatment system 1800. The dividing wall defined by the filter structure 1810 can include a frame member 1850 that provides structural support).
Friedman reinforces a filter against physical stresses from an auger or agitator (¶ [0130], The turbine 1520 can include a rotor with a central shaft 1521 and rotor blades 1528 as shown in FIG. 15C; ¶ [0134], The dividing wall defined by the filter structure can include a frame member 1725 that provides structural support; ¶ [0141], The dividing wall defined by the filter structure 1810 can include a frame member 1850 that provides structural support). One would be motivated to modify Hedrick, Wells and Wang with Friedman’s filter cage to reinforce the filter since Wang also relies on a moving auger. Therefore, it would have been obvious to modify Hedrick, Wells and Wang with Friedman’s filter cage in order to reinforce the filter against physical stresses.
Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over Hedrick, Wells and Wang in view of Schmidt; Hans-Weddo (DE 3914326 A1).
Regarding claim 62, Wang discloses a rotary implement (¶ [0039], [0044], auger 128). Hedrick, Wells and Wang lack a sliding ring. Schmidt discloses a filter device for the filtration of Suspensions, for clarifying liquids and for Ultra and microfiltration of liquids, constituting a separation module (col. 1, lines 1-10; col. 2, lines 30-40, Referring to FIG. 1, the filter device 1);
wherein the separation module further comprises a sliding ring (col. 2, lines 50-60, The wiper 6-9 consists of the actual wiper holder 6 , a permanent magnet 7 in the form of a rod, peripheral sealing elements 8 and the actual wiper 9 in the form of an elastic ring or a brush element);
the sliding ring being slidably disposed against a surface of a filter, wherein the sliding ring is configured to slide axially to clear the surface of the filter (col. 3, lines 20-25, inlet E1 drives the wiper 6-9 and cleans its pores by running over the filter element 10 and thereby pushing the existing one Liquid F 2 as a concentrate from the outlet A 2 through line 15, valve V5, line 18 into the reservoir V).
Schmidt does not arrange the sliding ring on the filter’s inner surface. However, Schmidt’s sliding ring is configured as a ring or torus shape, and is arranged between a pair of concentric cylinders (Fig. 1, wiper 6-9 is arranged between the filter housing 2 and filter element 10). A skilled artisan would have been able to modify Hedrick, Wells and Wang with Schmidt’s sliding ring by placing Schmidt’s sliding ring at any point inside or outside of Wang’s filter.
Schmidt automatically cleans a filter by magnetically propelling the sliding ring past the filter’s surface (col. 2, lines 55-65, On the outside of the housing 2, a reed relay R1 and R2 is arranged in the area of the end stops 4, which cooperate electrically with the permanent magnet 9). One would be motivated to modify Hedrick, Wells and Wang with Schmidt’s sliding ring to renew the filter by clearing any debris that has adhered to it. Therefore, it would have been obvious to modify Hedrick, Wells and Wang with Schmidt’s sliding ring in order to automatically renew a filter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hüttlin; Herbert DE 10125732 B4
Llull; Ramon et al. US 20140363891 A1
Baek; Sang-Hyun et al. US 20150034134 A1
Shippert; Ronald D. US 20150374888 A1
Venturi; Mark Louis US 20180117223 A1
Wurzer; Christoph et al. US 20190127681 A1
Bachrach; Nathaniel US 20190185814 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781