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 04/12/2023, 09/11/2024, 08/29/2025 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 § 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 (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 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 1-9, 13, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gil et al (US20110137315A1 published 06/09/2011; hereinafter Gil).
Regarding claim 1, Gil teaches a tissue cutting system comprising:
a tissue holder (a cutting block 20 – Figs. 5-7) with a hollow cavity (a bore 21 – Fig. 5), wherein the tissue holder is configured to hold a tissue sample within the hollow cavity (an osteochondral plug 70 within the bore 21 – Figs. 5-7);
a first cutting component (an angled blade 44 – Figs. 6-7) configured to cut a tissue sample contained within the hollow cavity of the tissue holder by scoring cuts in a first dimension and in a second dimension respectively (the angled blade 44 comprising two cutting members 62 scoring cuts in a first dimension and in a second dimension offset from the first dimension – Figs. 6-7), to produce a scored tissue sample (the two cutting members 62 score the osteochondral plug 70 – Figs. 7D-E);
a rotating device (a connecting member 64 that is rotatably fixed to the second end of threaded rod 41 – Fig. 4 and paragraph 33) configured to cause a relative rotational movement between the tissue holder and the first cutting component (connecting member 64 is capable of being rotated and cause a relative rotational movement between the cutting block 20 and the angled blade 44 – Fig. 4 and paragraph 33), between a first relative orientation and a second relative orientation (connecting member 64 is capable of being rotated between a first relative orientation and second relative orientation offset from the first orientation – Fig. 4 and paragraph 33),
wherein in the first relative orientation (“in the first relative orientation” is interpreted as intended use and deemed to read on a device capable of being placed in the first orientation) (the connecting member 64 is in the first relative orientation – Figs. 7D-E), the first cutting component is configured to cut the tissue sample contained within the tissue holder in the first dimension (the angled blade 44 scores the osteochondral plug 70 in the first and second dimensions – Figs. 7D-E) and
in the second relative orientation ( “in the second relative orientation” is interpreted as intended use and deemed to read on a rotating device capable of being placed in the second orientation) (the connecting member 64 is capable of being rotated to the second relative orientation – Figs. 7D-E), the first cutting component is configured to cut the tissue sample contained within the tissue holder in the second dimension (the angled blade 44 with the two cutting members 62 is capable of scoring the osteochondral plug 70 in the first and second dimensions – Fig. 4 and paragraph 33); and
a second cutting component (a cutting instrument or scalpel blade inserted into paring slot 22 – Fig. 7C and paragraph 43) configured to cut the scored tissue sample in a third dimension (“configured to cut the scored tissue sample” is interpreted as intended use and is deemed to read on a blade capable of cutting a sample) to produce tissue fragments (the scalpel blade is capable of cutting a scored osteochondral plug 70 in a third dimension to produce tissue fragments – Fig. 7C and paragraph 43).
Regarding claim 2, Gil teaches the tissue cutting system of claim 1, further comprising a drive assembly coupled with the tissue sample (a threaded rod 51 coupled to the osteochondral plug 70 – Fig. 7C), a portion of the scored tissue sample is exposed at an opening at a distal end of the tissue holder (a portion of the osteochondral plug 70 outside of the bore 21 – Fig. 7C) in response to activation of the drive assembly (rotating the threaded rod 51 pushes the osteochondral plug 70 within the bore 21 – Fig. 7C and paragraph 42).
Regarding claim 3, Gil teaches the tissue cutting system of claim 2, wherein the second cutting component is configured to cut an exposed portion of the scored tissue sample (the scalpel blade is capable of cutting an exposed portion of a scored osteochondral plug 70 – Fig. 7A and 7D).
Regarding claim 4, Gil teaches the tissue cutting system of claim 1, wherein the tissue holder further comprises a sacrificial tissue-support (a cutaway 28 – Figs. 7C-D), wherein the sacrificial tissue-support is configured to support the tissue sample (the cutaway 28 supports the osteochondral plug 70 – Figs. 7C-D), and wherein the second cutting component is configured to cut the tissue sample by cutting through the sacrificial tissue-support (the blade is capable of cutting off the cutaway 28 – Fig. 7C).
Regarding claim 5, Gil teaches the tissue cutting system of claim 4, wherein the sacrificial tissue-support includes a non-flat surface with a groove (the cutaway 28 comprises a non-flat surface between the trim channels 23 forming a groove – Figs. 7A-D), wherein the groove is configured to support the tissue sample (the groove between the trim channels 23 supports the osteochondral plug 70 – Fig. 7A).
Regarding claim 6, Gil teaches the tissue cutting system of claim 1, further comprising a translation assembly coupled to the tissue holder (an alignment slot 38 comprising a trimming post 39 coupled to the cutting block 20 – Fig. 7C-D) and configured to move the tissue holder containing the tissue sample with respect to the first cutting component and/or the second cutting component (the cutting block 20 is capable of being rotated about the trimming post 39 with respect to the angled blade 44 – Fig. 7C-D).
Regarding claim 7, Gil teaches the tissue cutting system of claim 6, wherein the translation assembly comprises a translation stage on which the tissue holder is mounted (a peripheral retention lip 72 holding the cutting block 20 to the alignment slot 38 – Figs. 7C-D), wherein the translation stage is configured to cause a translation motion of the tissue holder towards and away from the first cutting component and/or the second cutting component (the cutting block 20 is capable of be slid along the peripheral retention lip 72 towards and away from the angled blade 44 – Fig. 4).
Regarding claim 8, Gil teaches the tissue cutting system of claim 1, wherein a sidewall of the tissue holder comprises a slit (one of two trimming channels 23 – paragraph 38 and Fig. 7A), wherein the slit permits the first cutting component to pass through and cut the tissue sample while the tissue sample is contained within the hollow cavity of the tissue holder (the trimming channels 23 are shaped to receive angled blade 44 to cut the osteochondral graft – paragraph 39).
Regarding claim 9, Gil teaches the tissue cutting system of claim 8, wherein the slit is one of a plurality of slits (one of two trimming channels 23 – paragraph 38 and Fig. 7A, and wherein each of the plurality of slits permits the first cutting component to pass through and cut the tissue sample while the tissue sample is contained within the hollow cavity of the tissue holder (the trimming channels 23 are shaped to receive angled blade 44 to cut the osteochondral graft within the bore 21 of the cutting block 20 – paragraph 39 and Figs. 7D-E).
Regarding claim 13, Gil teaches the tissue cutting system of claim 1, wherein the first cutting component is configured to protrude into the hollow cavity (the angled blade 44 protrudes into the bore 21 – Figs. 7C-D) through an opening at a distal end of the tissue holder (the angled blade 44 protrudes into the bore 21 through an open end – Figs. 7C-D) and cut the tissue sample while the tissue sample is contained within the hollow cavity (the angled blade 44 cuts the osteochondral plug 70 – Figs. 7C-D).
Regarding claim 26, Gil teaches the tissue cutting system of claim 1, wherein the tissue sample is a live tissue sample (the osteochondral graft is a live tissue sample – paragraph 8).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Gil.
Regarding claim 10, Gil teaches the tissue cutting system of claim 9.
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[AltContent: textbox (the angle between the cutting members 62 changes the distance between the flanges 63)][AltContent: arrow]Although Gil does not teach wherein two adjacent slits of the plurality of slits are positioned apart within a range of 300 µm to 2000 µm, Gil teaches that one of skilled in the art can recognize that the many different angles between the cutting members 62 may be considered (paragraph 34).
It would have been obvious to one of ordinary skill in the art before the effective filing date to use an angle between the cutting members 62 such that the distance between the flanges 63 is within a range of 300 µm to 2000 µm; therefore, also having a distance between the trimming channels 23 within a range of 300 µm to 2000 µm because the flanges 63 of the cutting members 62 must fit in the trimming channels 23 (paragraph 39).
Regarding claim 11, Gil teaches the tissue cutting system of claim 8.
Although Gil does not teach wherein a width of the slit is within a range of 1 mm to 10 mm, Gil teaches that one of skilled in the art can recognize that shape and dimensions of the cutting members used in constructing the angled blade element maybe varied (paragraph 34).
It would have been obvious to one of ordinary skill in the art before the effective filing date to use a dimension such that the width of the cutting members are within a range of 1 mm to 10 mm; therefore, also having a width of the trimming channels 23 within a range of 1 mm to 10 mm because the flanges 63 of the cutting members 62 must fit in the trimming channels 23 (paragraph 39).
Regarding claim 12, Gil teaches the tissue cutting system of claim 8.
Although Gil does not teach wherein a depth of the slit is within a range of 50 µm to 1000 µm, Gil teaches that one of skilled in the art can recognize that shape and dimensions of the cutting members used in constructing the angled blade element maybe varied (paragraph 34).
It would have been obvious to one of ordinary skill in the art before the effective filing date use a dimension such that the depth of the cutting members are within a range of 50 µm to 1000 µm; therefore, also having a depth of the trimming channels 23 within a range of 50 µm to 1000 µm because the flanges 63 of the cutting members 62 must fit in the trimming channels 23 (paragraph 39).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Gil in view of Kong et al (US20060086221A1 published 04/27/2006; hereinafter Kong).
Regarding claim 14, Gil teaches the tissue cutting system of claim 1.
However, Gil does not teach a reservoir with an internal space, and a fluid material positioned within the internal space; wherein at least a portion of the tissue holder protrudes into the internal space of the reservoir and is submerged within the fluid material, and wherein the reservoir is configured to collect the tissue fragments within the internal space.
Kong teaches a tissue cutting device comprising
a reservoir with an internal space (a bath 120 having an aperture 122 and a sealant ring 124 – Fig. 3 and paragraph 25), and
a fluid material positioned within the internal space (a buffer medium 121 such as saline in the bath 120 – Fig. 3);
wherein at least a portion of the tissue holder protrudes into the internal space of the reservoir and is submerged within the fluid material (a specimen 148 in a specimen syringe 130 protruding into the bath 120 – Fig. 3), and wherein the reservoir is configured to collect the tissue fragments within the internal space (the bath 120 is capable of collecting the tissue fragments cut from the specimen 148 – Fig. 3). Kong teaches to use a buffer medium 121 to both lubricates the blade 168 as it cuts the specimen 148 and provides oxygen and nutrition to the specimen 148 (paragraph 25).
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 Gil, with the bath and buffer medium, taught by Kong, to both lubricates the blade 168 as it cuts the specimen 148 and provides oxygen and nutrition to the specimen 148.
Regarding claim 15, Gil, modified by Kong, teaches the tissue cutting system of claim 14, further comprising an oxygenation unit (the air above the bath 121 – Kong Fig. 3) including an oxygen source (oxygen in the air above the bath 121 – Fig. 3 and paragraph 10), wherein the oxygen source is coupled to the reservoir and is configured to oxygenate the fluid material in the internal space of the reservoir (oxygen in the air above the bath 121 dissolves into the buffer medium to supply oxygen to the specimen – Fig. 3 and paragraph 10).
Claims 16-19 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Gil, modified by Kong, in view of Orfield et al (US20150241324A1 published 08/27/2015; hereinafter Orfield)
Regarding claim 16, Gil, modified by Kong, teaches the tissue cutting system of claim 14.
However, Gil, modified by Kong, does not teach further comprising a nest configured to hold the reservoir, wherein the nest comprises a passageway for circulating a heat exchange fluid through the nest.
Orfield teaches a device for processing tissues sections comprising a nest (a system 100 with a controller 168 – Fig. 1 and paragraph 80) configured to hold the reservoir (the system 100 holds a reservoir 150 and temperature regulating module 180 – Fig. 1), wherein the nest comprises a passageway for circulating a heat exchange fluid through the nest (the system 100 comprises a fluid channel 110 for circulating a heat exchange fluid through the nest – Fig. 1). Orfield teaches to use a fluid channel 110 and controller 168 to reduce or eliminate any wrinkling of sections prior to or during mounting to a substrate 102 (paragraph 80) and to automate section processing (paragraph 39).
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 Gil as modified by Kong, with the system 100 with a reservoir 150 and fluid channel 110 arrangement, taught by Orfield, to automate section processing and to reduce wrinkling of sections. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Gil, Kong, Orfield teach devices for slicing tissue sample.
Regarding claim 17, Gil, as modified by Kong modified by Orfield, teaches the tissue cutting system of claim 16, wherein the heat exchange fluid circulated through the nest (“the heat exchange fluid circulated through the nest” is an intended use recitation and deemed to read on an equivalent device capable of being used in the same way) maintains the temperature of the reservoir and the fluid material in the reservoir within a range of 1 °C to 10 °C (the controller 168 is capable being used to circuit a heat exchange fluid through the system 10 and maintain the temperature of the reservoir 150 and the fluid in the reservoir 150 within a range of 1 °C to 10 °C – Orfield Fig. 1 and paragraph 80).
Regarding claim 18, Gil, as modified by Kong modified by Orfield, teaches the tissue cutting system of claim 16, wherein the heat exchange fluid circulated through the nest (“the heat exchange fluid circulated through the nest” is an intended use recitation and deemed to read on an equivalent device capable of being used in the same way) maintains the temperature of the reservoir and the fluid material in the reservoir within a range of 35°C to 38°C (the controller 168 is capable being used to circuit a heat exchange fluid through the system 10 and maintain the temperature of the reservoir 150 and the fluid in the reservoir 150 within a range of 35°C to 38°C – Orfield Fig. 1 and paragraph 80).
Regarding claim 19, Gil, as modified by Kong modified by Orfield, teaches the tissue cutting system of claim 16, further comprising a heat exchanger (the controller 168 is connected to the reservoir 150 – Orfield paragraph 38 and Fig. 1) configured to pump the heat exchange fluid through the passageway in the nest (the controller 168 commands a pump 167 to pump the heat exchange fluid through the fluid channel 110 – Orfield Fig. 1 and paragraph 66), and further comprising a temperature sensor (a temperature regulating module 180 – Orfield Fig. 1) configured to detect the temperature of the fluid material in the reservoir (the temperature regulating module 180 detects a temperature of the fluid in the reservoir 150 to maintain a range desired temperature range – Orfield paragraph 78).
Regarding claim 20, Gil, as modified by Kong, teaches the tissue cutting system of claim 14.
However, Gil, as modified by Kong, does not teach comprising a filter assembly attachable to the reservoir, wherein the filter assembly comprises at least a first filter unit configured to retain tissue fragments larger than a specified size.
Orfield teaches tissues sections processing system comprising a filter assembly attachable to the reservoir (a filtration module, comprising a filter 170’ and a filter 170, attached to the reservoir 150 – Fig. 1 and paragraph 71), wherein the filter assembly comprises at least a first filter unit configured to retain tissue fragments larger than a specified size (the filter 170’ is capable of retaining tissue fragments larger than a specified size – paragraph 71). Orfield teaches to use a filtration module with multiple filters to provide redundancy in removing undesired substances from the system 100 (paragraph 71).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the flow path, at taught by Gil as modified by Kong, with filtration module to prevent provide redundancy in removing undesired substances from the system. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Gil, Kong, Orfield teach devices for slicing tissue sample.
Regarding claim 21, Gil, as modified by Kong modified by Orfield, teaches the tissue cutting system of claim 20, wherein the filter assembly further comprises at least a second filter unit connected in series with the first filter unit (a filter 170 in series with the filter 170’ – Orfield Fig. 1), wherein the second filter unit is configured to retain tissue fragments of the specified size (the filter 170 is capable of retaining tissue fragments of the specified size – Orfield paragraph 71).
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Gil in view of Walter et al (US Pat No. 6,253,653 B1 published 04/27/2006; hereinafter Walter).
Regarding claim 22, Gil teaches the tissue cutting system of claim 1.
However, Gil does not teach wherein the rotating device is coupled to the tissue holder and is configured to rotate the tissue holder about a longitudinal axis between the first relative orientation and the second relative orientation.
Walter teaches a device for fabricating slices for microscopy wherein the rotating device is coupled to the tissue holder (a rotary shaft 16 coupled to a holder 6 – Figs. 1-2) and is configured to rotate the tissue holder about a longitudinal axis between the first relative orientation (the holder 6 at a first position – Figs. 1-2) and the second relative orientation (the holder 6 rotates to a second position near the blade 4– Figs. 1-2 and column 5 lines 60-61). Walter further teaches the ability to adjust the cut thickness by using a control circuit to change the position of the cutting blade or of the object (column 3 lines 13-16).
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 Gil, via reversal of parts, taught by Walther, to mount the cutting block 20 on the rotatable connecting member 64, because, per MPEP 2144.04 VI, mere reversal of such relative movement between the cutting block 20 and the angled blade 44 is an obvious modification (see In reGazda, 219 F.2d 449, 104 USPQ 400).
Regarding claim 23, Gil teaches the tissue cutting system of claim 1.
However, Gil does not teach wherein the rotating device rotates the tissue holder about the longitudinal axis by an angle of 90˚.
Walter teaches a device for fabricating slices for microscopy wherein the rotating device rotates the tissue holder about the longitudinal axis by an angle of 90˚ (a rotary shaft 16 coupled to a holder 6 rotates the holder by an angle of 90˚ – Figs. 1-2). Walter further teaches the ability to adjust the cut thickness by using a control circuit to change the position of the cutting blade or of the object (column 3 lines 13-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cutting block 20, as taught by Gil, with the rotary shaft 16 and control circuit, taught by Walter, to gain the ability to adjust the cut thickness. One of ordinary skill would have found automating a manual activity to be obvious (see In reVenner, 262 F.2d 91, 95, 120 USPQ 193, 194).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Gil in view of Laucher (US20140277030A1 published 09/18/2014).
Regarding claim 24, Gil teaches the tissue cutting system of claim 1.
However, Gil does not teach an oscillator coupled to the first cutting component and the second cutting component; the oscillator configured to oscillate the first cutting component and the second cutting component at a frequency within a range of 20 Hz to 200 Hz.
Laucher teaches an ultrasonic surgical device comprising an oscillator coupled to the first cutting component (a piezoelectric motor 50 drives a blade 40 disposed within a second conduit – paragraph 42 and Fig. 1) and the second cutting component (piezoelectric motor 50 drives the blade 40 – paragraph 42 and Fig. 1); the oscillator configured to oscillate the first cutting component and the second cutting component at a frequency within a range of 20 Hz to 200 Hz (mechanical vibrations that are transmitted to a surgical end-effector at ultrasonic frequencies – paragraph 7). Laucher teaches to use an ultrasonic blade to provide fine dissection capabilities of bone without damaging nerves (paragraph 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the angled blade and scalpel, as taught by Gil, with the piezoelectric motor 50, taught by Laucher, to provide fine dissection capabilities of bone without damaging nerves. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Gil and Laucher teach surgical devices for cutting bone.
Regarding claim 25, Gil, modified by Laucher, teaches the tissue cutting system of claim 24, further comprising a mount (a back plate 34 – Gil Fig. 3), wherein the first cutting component and the second cutting component are coupled to the mount (the angled blade 44 and the scalpel are connected to the back plate 34 – Gil Fig. 3 and Fig. 7C), wherein a first cutting plane of the first cutting component (a first cutting plane of the angled blade 44 – Fig. 3) intersects a second cutting plane of the second cutting component at an angle (the first cutting plane intersects a second cutting plane of the scalpel at an angle – Gil Figs. 3 and 7D).
Conclusion
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/T.C.S./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796