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 .
Status of the Claims
Claims 1-22 are pending in the application and under consideration.
Claim Rejections - 35 USC § 102
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 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)(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.
Claims 1-17 and 20-22 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Khalaj (US 2020/0061258 A1).
As to claim 1, Kahlaj teaches a processing arrangement 1/2/10 for tissue material 12 removed from a patient (Fig.1; [0046]) and to be applied after processing (tissue homogenizer with syringes 1,2 and processing device 10 to deglomerate tissue samples without damaging cells or cell clusters for injection into patient [0044],ll.1-12; [0093]), comprising:
PNG
media_image1.png
173
425
media_image1.png
Greyscale
a collection container 1/2 (syringe 1 or 2; Fig.1,3-4) which has a collection receptacle (as collection receptacle within syringe 1 or 2) for receiving the tissue material 12 removed by a tissue removal device (Fig.1; [0046],ll.4-20); a processing container 10 (as container 10; Fig.1,3-4) which has a mixing receptacle (as fluid path within container 10 between ends as housing members 102a,b [0055]) for jointly receiving the tissue material 12 (Fig.1; [0046],ll.4-20) and a liquid medium (where a tumescent solution as a liquid medium is added to adipose tissue during removal [0005],ll.3-4,1-12); and
PNG
media_image2.png
344
444
media_image2.png
Greyscale
a processing device 222/112 (slicer 222 [0072]-[0086] Fig.3-4; extending cutting blades 112; Fig.3-4; ) for mixing the tissue material and the medium (where different angle and extending blades 112 would necessarily mixing tissue material and medium as tumescent solution are combined during tissue removal [0005];Fig.3-4; [0049]-[0051], wherein a connection device 11 (Fig.3,5 [0055]-[0056]) is provided, on which a first fastener 11a (port 11a as Luer lock on port 11a Fig.3 of Luer lock mating pair of port 11 adapted to connecting tip 22 of syringe 20 Fig.3; [0056],ll.7-21) for attaching the collection container 1 and a second fastener 11b (as Luer lock on port 11b Fig.3 adapted for connecting tip 22 of processing container as syringe 2 Fig.3; [0056],ll.7-21) for attaching the processing container (container 10) and one passage opening (as passage opening within housing members 102a,b forming inner volume within container 10 Fig.3,1 [0055]) which is positioned between the collection receptacle 1 and the mixing receptacle (within 10 Fig.3) (Fig.1,3; [0055]).
As to claims 2-3, Khalaj teaches wherein: (claim 2/1) (where claim 2 is dependent from claim 1) a comminuting tool 222 (slicer disc 222 comprising slicer members 224 and slicer apertures 226 Fig.3; [0050]) is provided at the passage opening (between housing members 102a and 102b, Fig.3-4,1 [0050]; and (claim 3/2) the comminuting tool is formed by a disc (as disc shape of comminuting tool/slicer 222 Fig.3) which is rotatably mounted on the connection device 11 (where housing member 102a,b threaded ends allow loosening of ends that allow rotational mounting of disc 222 Fig.3) and has at least one cutting element 224 (slicer members 224 defining slider apertures 226 Fig.3-4; [0050]).
As to claims 4-5 and 12-13, Khalaj teaches wherein: (claim 4/1) (where claim 4 is dependent from claim 1) a mixing tool 112/within 102b (longitudinally and other angle projecting cutting blades 112) projects into the mixing receptacle (of 10) on the processing container 10 (where extended, different angle blades would necessarily mix the tissue/medium when repeatedly passed from either syringe 1 or 2 through the processing device 10 Fig.3; [0059]); (claim 5/4) the mixing tool is formed by an agitator as (edges of blades 112 Fig.3) which is rotatably mounted on the processing container 10 (Fig.3) and can be driven by the processing device (where 10 can be opened via threaded ends 102a,b, necessarily allowing rotatable mounting of mixing tool 112 within 10 and where agitator can be driven by movement of tissue/medium through 10 via alternative pushing and pulling of pistons in collection container 1 syringe 1 or 2 (Fig.3, as further presented above for claim 1); (claim 12/4) the processing device has at least one drive 1a/2a (plunger 1a or 2a of syringes 1 or 2 Fig.1) and a processing receptacle (within 10 attaching collection 1 and 2 comprising drives/plungers 1a and 2a Fig.3) for the connection device 11a/b with the collection container 1/2 and the processing container 10 attached thereto Fig.3, and the at least one drive 1a,2a forms a first drive connection (via connection device 11a and/or 11/b, each having Luer lock connection connected to syringe/collection device 1 and 2, as presented above) with the mixing tool 112 in a receiving position (as where mixing tool 112 at either end 102a,b receives tissue/medium from either collection device/syringes 1,2 Fig.3, as presented above); and (claim 13/12) the at least one drive 1a/2a in the receiving position also forms a second drive connection (via seal 122 and device 10 ends 102a,b connected to drive 1a/2a via rest of syringe and port 11a/b with Luer locks) with a comminuting tool 222 (slicer disc 222 comprising slicer members 224 and slicer apertures 226 Fig.3; [0050]).
As to claims 6-8, Khalaj teaches wherein: (claim 6/1) (where claim 6 is dependent from claim 1) the collection container 1/2 has a closing element (as complementary Luer locks that connect to Luer locks on ports 11a/b) which can be adjusted between a closed position in which it closes the collection receptacle and an open position in which the collection receptacle is at least partially open (where: (a) disconnecting complementary Luer locks of collection containers 1,2 from port 11 Luer locks puts the closing element in a closed position and (b) connecting complementary Luer locks of collection containers 1,2 from port 11 Luer locks puts the closing element in an open position Fig.3; [0056],ll.7-21); (claim 7/6) when the first fastener 11a Luer locks of the connection device 11 are connected to a counter-fastener (complementary Luer locks) of the collection container 1/2, the closing element can be brought automatically into a second open position in which a container opening of the collection container is open (container opening as opening at end of syringe 1 or 2 in a second open position as connected to first fastener 11a Luer locks opens container opening of ½ Fig.3;[0056],ll.7-21); (claim 8/7) the first fastener 11a/b and the first counter fastener (complementary Luer lock on collection containers 1,2) form a first slide-in connection and the closing element (complementary Luer locks on 1,2) is designed in the shape of a slide and can, by a sliding-in movement of the first fastener relative to the first counter-fastener, be displaced from the closed position into the second open position (where Luer locks and complementary Luer locks form rotating sliding structures that make a rotatingly first sliding connection as the complementary Luer locks Fig.1; [0056],ll.7-21).
As to claims 9-11, Khalaj teaches wherein: (claim 9/1) (where claim 9 is dependent from claim 1)the processing container 10 has a closing element (as Luer locks on port 11a) which can be adjusted between a final position in which it closes the mixing receptacle (within 10, as presented above) and a receiving position in which the mixing receptacle is open (where: (a) disconnecting complementary Luer locks of collection containers 1 from port 11a Luer locks of Luer locks on port 11a of processing container 10 puts the closing element in a final position and (b) connecting complementary Luer locks of collection container 1 from port 11a Luer locks of 10 puts the closing element in a receiving position Fig.3; [0056],ll.7-21);; (claim 10/9) the closing element (as Luer locks on port 11a; Fig.3) can be brought into the receiving position automatically when the second fastener (Luer lock of 11b) of the connection device 11b is connected (via seals 122 and end members 102a,b; Fig.3) to a second counter-fastener (Luer lock 11a) of the processing container 10 (Fig.3); and (claim 11/10) the second fastener 11b and the second counter-fastener 11a form a second slide-in connection and the closing element is formed by a closure slide (complementary Luer lock on collection containers 1,2) which can be transferred by a push-in movement of the second fastener relative to the second counter-fastener from the final position into the receiving position (where Luer locks and complementary Luer locks form rotating sliding structures that make a rotatingly first sliding connection by a push-in movement as the complementary Luer locks Fig.1; [0056],ll.7-21).
As to claim 14/1 (where claim 14 is dependent from claim 1), Khalaj teaches wherein the collection container 1 has a piston (as piston of syringe 1 as collection container 1 Fig.3) for emptying the collection receptacle 1 in the direction of the passage opening (between 102a and 102b Fig.3).
As to claims 15-17, Khalaj teaches wherein: (claim 15/1) (where claim 15 is dependent from claim 1) the processing container 2 has a closable input/output connection (as Luer lock connection on processing container/syringe 2 that can be closable for input and output connection, as Luer lock on port 11b Fig.3 of Luer lock mating pair of port 11b adapted to connecting tip 22 of processing container/syringe 2 Fig.3; [0056],ll.7-21); (claim 16/15) a slide (as piston/punger of syringe 1 as collection container 1 Fig.3) for emptying the mixing receptacle (as mixing receptacle within syringe 2) via the input/output connection (Luer lock as presented above) is provided on the processing container 2 (Fig.1; [0047],ll.8-19); and (claim 17/16) the processing device has at least one actuator (as external end of plunger Fig.1) for actuating the piston (external end of plunger manipulated to actuate the piston/plunger of collection container/syringe 1/2; Fig.1; [0047],ll.8-19).
As to claims 20-22, Khalaj teaches wherein: (claim 20/1) (where claim 20 is dependent from claim 1) the collection container 1/2 can be detachably fixed to a connection housing (as portion of ports 11a,b Fig.3) of a collection device 10 which is arranged for separating and collecting tissue material from a fluid flow between a tissue removal device and a vacuum device (e.g., where syringe 2 can be used to create a vacuum as negative pressure to facilitate movement of the tissue/medium between the collection containers 1 and 2 and through the processing container 10 Fig.3; [0047],ll.17-20,8-20); (claim 21/20) the collection container 10 has [a configuration that allows to have] a flow portion of a connection path between a shaver-side flow connection which can be fluidically connected to the tissue removal device 10 (where the shaver side flow connection is provided by, and a function of, the liposuction cannula as having side holes that allow side flow action that shaves fat tissue for removal in addition to just suction through the cannula, as well known in the art, such that this structure is not part of the processing arrangement as claimed, and therefore is not considered for patentability) ; and a flow connection (e.g., Luer lock on port 11b; Fig.3) which can be fluidically connected to the vacuum device (e.g., syringe 2; [0047],ll.17-20,8-20); and (claim 22/20) the closing element of the collection container 1/2 can be brought automatically from: a first open position (where complementary Luer locks of collection container/syringe 1,2 are connected to Luer locks of ports 11a,b of processing container 10 which provides an automatic open position where tissue/medium can pass from ports 11a,b as connection housing through processing container 10) into the closed position when the collection container is removed from the connection housing) and into the closed position when the collection container 10 is removed from the connection housing (where collection container/syringe 1/2 automatically closes path with collection container 10, Fig.3, as presented above).
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(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103 and potential 35 U.S.C. 102(a)(2) prior art under 35 U.S.C. 103. Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Khalaj.
As to claim 18, Khalaj does not teach wherein the processing device has an electronic device for at least partially automated activation of at least one drive (piston/plunger 1a,2a) and/or at least one actuator (as external end of plunger of syringe 1,2). However, Khalaj teaches that the at least one drive (piston/plunger 1a,2a) and/or at least one actuator (as external end of plunger of syringe 1,2) is actuated by applying positive pressure to the external end of the syringe and does not limit or restrict how this is done ([0047],ll.8-19). It would have been obvious of one of skill before the effective filing date to modify the teachings of Khalaj to provide an electronic device to at least partially actuate the drive and/or actuator, and one of skill would have been motivated to do so, in order to provide an automated system to process the tissue and medium by passing the tissue/medium through the processing container 10 between the collection containers as syringes 1,2 that would function more efficiently and under more precise control than actuating the drive/piston or actuator by hand.
As to claim 19, Khalaj does not teach wherein a camera is provided on the processing device for the visual recording of the mixing receptacle.
However, it would have been obvious of one of skill before the effective filing date to modify the teachings of Khalaj to provide a camera on the processing device 10 for visual recording of the mixing receptacle, and one of skill would have been motivated to do so, in order to provide an automated system to visual monitor the processing of the tissue and medium by passing the tissue/medium through the processing container 10 between the collection containers as syringes 1,2 that would function more efficiently and under more precise control than actuating the drive/piston or actuator by hand by using a camera to monitor the processing of the tissue to visually determine when the processing was complete.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA EISENBERG, can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781