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 .
Election/Restrictions
Applicant’s election without traverse of Claims 1-10, and 20 in the reply filed on 12/13/2022 is acknowledged.
Claims 11-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected medical product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/13/2022.
Claims 1-10, and 20 are pending examination in this response.
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 1-3, 5, 6, and 8 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Rebellino et. al. (WO 2021076753 A2).
Regarding claim 1, Rebellino teaches “A device for targeted material excision from a tissue sample” (Abstract and Title, needle biopsy device, tissue sample holder); “the device comprising: a support” (Para [000134], tissue sample holder (500)); “defining an opening” (Para [000123], open distal end (514), proximal end (518), needle receiving portion (516)); “and providing a region below the opening for positioning a tissue sample” (Paras [000138] and [000127] and Fig 21A, tissue sample holder (500), Tray receiver (520) includes a locator (522) to promote holding tissue tray (560) in a predetermined position. In the present example, locator (522) is formed as a slight overhang, L-shaped portion, or J-shaped portion.); “a tissue stabilizer receivable in the opening of the support, the tissue stabilizer defining a shape that complements a shape of the support defining the opening;” (Para [000123], open distal end (514), proximal end (518), needle receiving portion (516)); “and a cutting tool assembly receivable in the tissue stabilizer,” (Fig. 21A, number 20 needle assembly); “the cutting tool assembly including a hollow cutter having a bore,” (Para [00049] [00051] and [00053], are used to drive needle assembly (20) through a cutting cycle and a tissue acquisition cycle. elongate cutter (40). Cutter (40) comprises a generally hollow cylindrical tube); “the cutting tool assembly being movable relative to the tissue stabilizer to cause the cutter to excise material from the tissue sample” (Para [00051], needle assembly comprises piercer (22) is generally movable relative to cutter (40) to pierce tissue and collect tissue samples, while cutter is generally movable relative to piercer (22) to sever tissue samples.); “and retain the excised material within the bore when the tissue sample is positioned below the opening of the support.” (Para {0057], issue collection feature (54) generally defines an elongate notch that is open to cannula portion (44) of cutter (40).)
Regarding claim 2, Rebellino teaches all of claim 1 as above in addition to “wherein the cutting tool assembly includes a collet chuck configured to hold the hollow cutter in an orientation with an excise end of the cutter directed toward the tissue sample,” (Para [00056] and [0057], End portion (50) of cutter (40) comprises a receiving feature (52) and a tissue collection feature (54). As with receiving feature (32) of piercer (22), receiving feature (52) of end portion (50) comprises a cylindrical indentation, slot, or other receiving feature that is configured to receive at least a portion of a cutter drive assembly (200). As will be described in greater detail below, receiving feature (52) is configured to receive at least a portion of cutter drive assembly (200) to permit cutter drive assembly (200) to move cutter (40) through a predetermined sequence of movement.). Therefore the end portion holds in place the cannula portion which is the hollow part of the cutter and is the collet chuck which holds the cutter in an orientation to direct the cutter toward the tissue sample.
Rebellino further teaches “and further includes a chuck holder to couple to the collect chuck to facilitate manipulation of the cutting tool assembly by a user.” (Para [00096], Rotation of cutter (40) and piercer (22) also results in rotation of driver (53) of end portion (50). In particular, driver (53) is generally aligned with tissue collection feature (54) such that driver (53) likewise moves from an upward orientation to a downward orientation). Therefore the rotation of the driver holding the end portion of the cutter teaches to the chuck holder.
Regarding claim 3, Rebellino teaches all of claim 1 in addition to “wherein the support includes a base and a support arm attached to the base and defining the opening of the support.” (Fig. 20 and Paras [000123] and [000127], needle receiving portion (516) and includes a locator (522) to promote holding tissue tray (560)). Therefore the base is the front end of the housing 510 where 514 is and 516 begins and the support arm is 522.
Regarding claim 5, Rebellino all of claim 1 in addition to “further comprising a plunger receivable in the bore of the hollow cutter to expel material excised from the tissue sample.” (Paras [00079], [0083], and [000134], Meanwhile, at least some resiliency is provided so that each wiper (250) can push or otherwise move a tissue sample. As the selected wiper (250) sweeps across notch (26), manipulation portion (254) engages the tissue sample (TS) to push the tissue sample (TS) out of tissue collection feature (54). Meanwhile, at least some resiliency is provided so that wiper (550) can push or otherwise move a tissue sample. )
Regarding claim 6, Rebellino all of claim 1 in addition to “wherein the opening in the support is asymmetric and wherein the shape defined by the tissue stabilizer complements the asymmetric opening.” (Fig.20).
Regarding claim 8, Rebellino all of claim 1 in addition to, wherein the tissue stabilizer and the cutting tool assembly are separable parts or wherein the tissue stabilizer and the cutting tool assembly form one integrated module. (Figs. 2, 20 and 21A, 516 needle receiving portion and 20 needle assembly which houses the cutter).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Rebellino et. al. (WO 2021076753 A2) as applied to claim 3 above and further in view of Haberstich et. al. (CN 101099684 A).
Regarding claim 4, Rebellino teaches all of claim 3 but does not explicitly teach “wherein the base is crescent shaped and configured to at least partially surround the tissue sample when the tissue sample is positioned below the opening of the support.”. Rebellino does teach that the base portion is semi-cylindrical within (Para [000124], Needle receiving portion (516) is generally configured as a semi-cylindrical indentation or bulge in the otherwise cylindrical shape of outer housing (510).
Haberstich teaches a needle core biopsy system in addition to “wherein the base is crescent shaped and configured to at least partially surround the tissue sample when the tissue sample is positioned below the opening of the support.” (Page 8, First in the second target guide 206 placed on the first rail 122 prior to the sleeve base 260 to adjustably target on the second rail 206, so as to set a predetermined puncture depth. in particular, the depth guide 290 by depth indicator of the crescent 292 is formed, the depth indicator 292 has one shape from the engaging top and bottom guide flanges 266, 268 of the side groove 296. set forwards inclined surface on side 298 of top and bottom groove 296 to engagement with the second target track 206 on the convex tooth surface 270, the target track 206 of the distal end insertion depth mark 292 to assemble.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rebellino to incorporate the teachings of Haberstich wherein the to have the base in a crescent shape. Doing so would increase precision and control of the tissues within the device.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Rebellino et. al. (WO 2021076753 A2) as applied to claim 1 above and further in view of Goldenberg (US 20050054947 A1).
Regarding claim 7, Rebellino teaches all of claim 1 as above but does not explicitly teach “wherein the tissue stabilizer includes an internal helical groove”. However Rebellino does teach a bulge within the tissue stabilizer within (Para [000124], Needle receiving portion (516) is generally configured as a semi-cylindrical indentation or bulge in the otherwise cylindrical shape of outer housing (510). Needle receiving portion (516) is generally sized to correspond to the size and shape of needle assembly (20).).
Goldenberg teaches a biopsy needle that is particularly suited for shearing and collecting soft tissue specimens in addition to “wherein the tissue stabilizer includes an internal helical groove” (Para [0035] It will also be appreciated that an opposite arrangement that achieves the same result can be provided, namely, one in which the outer cannula 120 has one or more projections that travel in a helical groove associated with the housing. Thus, after the flange 121 is disengages, the outer cannula 120 moves axially forward and also begins to rotate since the pin or projections that are part of the cannula 120 ride within the helical groove, so as to cause rotation of the outer cannula as it is axially advanced.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rebellino to incorporate the teachings of Goldenberg wherein the to have the base in a wherein the tissue stabilizer includes an internal helical groove. Doing so decreases the damage to the tissue during movement of the cutting tool.
Rebellino does not explicitly teach “the cutting tool assembly includes on its outer surface a protrusion, and wherein movement of the cutting tool assembly relative to the tissue stabilizer is guided by the protrusion traversing the internal helical groove.”. But does teach keyed portion that can take on different shapes which acts like protrusions within (Para [000129], and [000130],The proximal end of shaft (542) includes a keyed portion (544) that is configured to communicate with either a manual or motorized driver to rotate shaft (542). Although keyed portion (544) of the present example is formed of a generally rectangular channel or keyway, it should be understood that keyed portion (544) can have a variety of configurations suitable to transfer rotary motion such as keys, a plurality of keyways or channels, a square shape, a hexagonal shape, a D-shape, and/or etc. For instance, in some examples, keyed portion (544) is rotatably coupled to any suitable portion of drive assembly (100) such as cutter drive assembly (120)).
Goldenberg teaches “the cutting tool assembly includes on its outer surface a protrusion, and wherein movement of the cutting tool assembly relative to the tissue stabilizer is guided by the protrusion traversing the internal helical groove.”. (Within Para [0035] as stated above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rebellino to incorporate the teachings of Goldenberg wherein cutting tool assembly includes on its outer surface a protrusion which assists in movement. Doing so decreases the damage to the tissue during movement of the cutting tool and allows the cutter to work with the helical groove.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rebellino et. al. (WO 2021076753 A2) as applied to claim 1 above and further in view of Anderson et. al (KR 102099349 B1) and Kilper (US 8268265 B2).
Regarding claim 9, Rebellino teaches all of claim 1 as above but does not explicitly teach “in combination with a substrate, wherein the substrate enables holding of the tissue sample between layers of the substrate.”. Rebellino does teach a tissue tray which is a substrate within (Para [000124], Tissue tray (560) includes a tissue receiver (562) configured to receive a plurality of tissue samples and a handle (566) extending proximally from the tissue receiver (562).
Anderson teaches methods and apparatus for tissue grafting and copying in addition to layers which include a substrate and tissues within (Pages 16, 17, and Fig. 13 B and Like the tissue 100 stabilization described above, the substrate 1030 is positioned on the donor tissue 100 while the harvested tubes 510 and 1010 are inserted between the tissue 100 and the slat 1315. In addition, the substrate 1310 can facilitate the placement of the tube 510.).
Kilper teaches tissues within layers of adhesive film within (Column 1 lines 46-48, Most of the techniques developed for taking up the cut-out tissue are based on the application of layers of adhesive film.).
Provided the claims require the tissues to be between layers of a substrate, , Rebellino does not teach such arrangement. However, it would have been within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Rebellino by having such arrangement, since Anderson teaches a substrate with tissue deposited on it and within Kilper it is known in the art that tissues are within layers of films which are substrates. It would have been a matter of an obvious engineering choice, to better stabilize the tissues as taught within Anderson and having an adhesive film as taught within Kilper would further stabilize the tissues.
Regarding claim 10, modified Rebellino teaches all of claim 9 as above but does not explicitly teach “wherein the layers of the substrate include a sheet of transparent film, a porous under-pad, and a silicone cushion.”
However, it would have been within the ordinary skills of an artisan before the effective filing date of the claimed invention to have further modified the invention of Rebellino by having the film be transparent, since Rebellino teaches the housing is transparent in order to visualize the tissue sample within (Para [000123], In the present example, outer housing (510) is generally transparent to promote visibility of tissue samples during sample collection.). It would have been a matter of an obvious engineering choice, have the substate be a transparent film in order to visualize the tissues as taught within Rebellino and Kilper teaches within (Column 1 lines 46-48, above) that the substate is film layers.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Rebellino et. al. (WO 2021076753 A2) and further in view of Anderson et. al (KR 102099349 B1) and Kilper (US 8268265 B2).
Regarding claim 20, Rebellino teaches “A system for targeted material excision from a tissue sample,” (Abstract and Title, needle biopsy device, tissue sample holder).
Rebellino does not explicitly teach “the system comprising: a substrate for holding a tissue sample between layers of the substrate”.
Rebellino does teach a tissue tray which is a substrate within (Para [000124], Tissue tray (560) includes a tissue receiver (562) configured to receive a plurality of tissue samples and a handle (566) extending proximally from the tissue receiver (562).
Anderson teaches methods and apparatus for tissue grafting and copying in addition to layers which include a substrate and tissues within (Pages 16, 17, and Fig. 13 B and Like the tissue 100 stabilization described above, the substrate 1030 is positioned on the donor tissue 100 while the harvested tubes 510 and 1010 are inserted between the tissue 100 and the slat 1315. In addition, the substrate 1310 can facilitate the placement of the tube 510.).
Kilper teaches tissues within layers of adhesive film within (Column 1 lines 46-48, Most of the techniques developed for taking up the cut-out tissue are based on the application of layers of adhesive film.).
Provided the claims require the tissues to be between layers of a substrate, Rebellino does not teach such arrangement.
However, it would have been within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Rebellino by having such arrangement, since Anderson teaches a substrate with tissue deposited on it and within Kilper it is known in the art that tissues are within layers of films which are substrates. It would have been a matter of an obvious engineering choice, to better stabilize the tissues as taught within Anderson and having an adhesive film as taught within Kilper would further stabilize the tissues.
Further taught by Rebellino “and a device for targeted material excision,” (Abstract and Title, needle biopsy device, tissue sample holder); “the device including: a support” (Para [000134], tissue sample holder (500)); “defining an opening” (Para [000123], open distal end (514), proximal end (518), needle receiving portion (516)); “and providing a region below the opening for positioning the tissue sample held by the substrate;” (Paras [000138] and [000127] and Fig 21A, tissue sample holder (500), Tray receiver (520) includes a locator (522) to promote holding tissue tray (560) in a predetermined position. In the present example, locator (522) is formed as a slight overhang, L-shaped portion, or J-shaped portion.); “a tissue stabilizer receivable in the opening of the support, the tissue stabilizer defining a shape that complements a shape of the support defining the opening;” (Para [000123], open distal end (514), proximal end (518), needle receiving portion (516)); “and a cutting tool assembly receivable in the tissue stabilize” (Fig. 21A, number 20 needle assembly); “the cutting tool assembly including a hollow cutter having a bore,” (Para [00049] [00051] and [00053], are used to drive needle assembly (20) through a cutting cycle and a tissue acquisition cycle. elongate cutter (40). Cutter (40) comprises a generally hollow cylindrical tube); “the cutting tool assembly being movable relative to the tissue stabilizer to cause the cutter to excise material from the tissue sample” (Para [00051], needle assembly comprises piercer (22) is generally movable relative to cutter (40) to pierce tissue and collect tissue samples, while cutter is generally movable relative to piercer (22) to sever tissue samples.); “and retain the excised material within the bore when the tissue sample is positioned below the opening of the support.” (Para {0057], issue collection feature (54) generally defines an elongate notch that is open to cannula portion (44) of cutter (40).).
Conclusion
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798