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 .
Response to Amendment
The amendment filed on July 19, 2026 was considered by the examiner. Claims 1-20 are pending in the application.
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 1-4, 7-8, 12, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US Patent Application Publication 2015/0272556 – cited in prior action), hereinafter Lee, in view of Voegele (US Patent 7,766,843 B2 – cited in prior action), hereinafter Voegele, and in view of Marino (US Patent Application Publication 2008/0077147 – cited in prior action), hereinafter Marino, and in view of Janssens (US Patent Application Publication 2009/0018468 – cited in prior action), hereinafter Janssens.
Regarding Claim 1, Lee teaches a biopsy assembly (see abstract), which may include a handler region to be usable by a user (see ¶[0084]-[0085]; Figs. 4A-4B). Lee teaches an apparatus (see abstract, the biopsy assembly) comprising:
a rotatable sampling element (¶[0188]-[0190] the coring component 1450 and the biopsy catheter 1404; Fig. 14) including:
a cylindrical body (¶[0188] the cylindrical body of the coring component 1450; Fig. 14) defining a receiving chamber (¶[0190] the interior of the coring component 1450 adjacent to the suction bay 1462 and/or the suction bay 1462; Fig. 14), the receiving chamber being configured to receive therein a tissue sample cut from a tissue mass (¶[0190] once the target tissue is parted off, the target tissue is aspirated into the suction bay 1462; Fig. 14); and
a cutting element disposed at a distal end of the cylindrical body to cut the tissue sample from the tissue mass abutting the distal end responsive to rotation of the cylindrical body as the cutting element is pressed against the tissue mass (¶[0188]-[0190] the coring component 1450 for parting off the target tissue, the coring component 1450 may take the embodiment of those described in Figs. 5-8C and 9A-9F, ¶[0016], ¶[0069], ¶[0084]-[0085], ¶[0103]-[0104], ¶[0112], ¶[0124], and ¶[0135] the various embodiments of the blade arrangement (the coring component) may be configured to rotate; Figs. 5-8C, 9A-9F, and 14),
wherein the cutting element includes one or more piercing ends (¶[0132]-[0135] the cutting edges 795 of the blades 791; Fig. 7D) and one or more lateral cutting edges, each lateral cutting edge angling away from a respective one of the one or more piercing ends (¶[0132]-[0135] the lateral cutting edge blades 798 of the blades 791, the lateral cutting edge blades 798 are angled away from the blades 791; Fig. 7D) and extending along a slot defined by the cylindrical body toward the distal end (¶[0132]-[0135] the elongate slits 792 for separating the blades 791; Fig. 7D);
a flexible drive shaft having a distal end fixably engaged with a proximal end of the rotatable sampling element (¶[0188]-[0190] the biopsy catheter 1404, ¶[0084]-[0085] the biopsy catheter is utilized in multiple embodiments, and is shown as being flexible, see curve in Fig. 4B; Figs. 4B and 14), the flexible drive shaft being linearly movable to motivate the rotatable sampling element along an axis to press the cutting element against the tissue mass and rotatable to impart rotational force to the rotatable sampling element to cause the rotatable sampling element to rotate around the axis (¶[0016], ¶[0069], and ¶[0084]-[0085] the proximal end of the biopsy catheter may be coupled to a catheter, the rotation of the handle causes the catheter to rotate, as the catheter is connected to the coring component, and the coring component is configured to rotate, the rotation of the handle would translate to the coring component; Fig. 14);
a sheath configured to receive therein the rotatable sampling element and at least a portion of the flexible drive shaft and further configured to convey the rotatable sampling element adjacent the tissue mass (¶[0188]-[0190] the catheter 1402; Fig. 14); and
an actuator handle (¶[0084]-[0085] the control handle 434; Figs. 4A-4B) including:
a control actuator rotatably and translatably disposed over a proximal end of the housing and coupled to the flexible drive shaft to enable linear advancement through rotational input to the rotatable sampling element within the sheath (¶[0084]-[0085] the control handle 434 allows for manual rotation and extension of the biopsy catheter through the catheter; Figs. 4A-4B and 14),
wherein the control actuator includes a cylindrical housing (¶[0084]-[0085] the handle body, note while 430 appears to be associated with the handle body, this should be associated with the handle base as also stated by Lee; Figs. 4A-4B).
Lee is silent regarding that the actuator handle includes a sheath actuator including a cylindrical sleeve and a housing movable within the cylindrical sleeve, the housing coupled to the sheath and configured to enable advancement of the sheath relative to the cylindrical sleeve.
Voegele teaches biopsy methods/devices (see abstract; Figs. 1-3). Voegele teaches an actuator handle (col. 2 ln. 30-60, the handle 45; Fig. 1) including: a sheath actuator (col. 2 ln. 52-60, the outer sheath assembly 40; Fig. 1) including a cylindrical sleeve (see Figs.2a-2c, the sleeve 44) and a housing movable within the sleeve (col. 3 ln. 8-35 and col. 4 ln. 4-20, the cannular carrier 42; Figs. 2a-2c), the housing coupled to the sheath (col. 3 ln. 21-35, the sheath is the cannula 14, the cannula 14 is disposed on a distal face of the carrier 42; Figs. 2a-2c) and configured to enable advancement of the sheath relative to the sleeve 44 (col. 4 ln. 4-20, the movement of the carrier 42 causes the cannula 14 to move; Figs. 2a-2c show the movement of the carrier 42 and the cannula 14 relative to the sleeve 44).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the sheath actuator of Voegele with the actuator handle of Lee because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the sheath actuator may allow the sampling port to be covered, which would prevent tissue from entering the sampling port during insertion/removal of the device (see Voegele col. 3 ln. 44-60); and/or (3) the sheath actuator would provide additional control to the sheath (navigation catheter) without the user needing to rely on movement of the handle 410 for movement of the sheath (navigation catheter), so that more minute movements of the sheath may be accomplished via the sheath actuator as compared to utilizing the handle 410. Here, the combination would include the sheath actuator being incorporated onto the handle 410 of the device of Lee, such that the sheath actuator of Voegele is utilized alongside the actuator handle 434 of Lee, wherein the sheath actuator controls the sheath of Lee and the control actuator still provides control to the biopsy catheter. Here, the sheath actuator would provide additional control to the sheath (navigation catheter) without the user needing to rely on movement of the handle 410 for movement of the sheath (navigation catheter). In this way, the user would instead utilize the actuator handle to move the sheath relative to the handle 410 so that more minute movements of the sheath may be accomplished via the sheath actuator as compared to utilizing the handle 410. In this way, the sheath actuator is incorporated onto the handle 410, alongside the handle 434, to provide the user with more control to the sheath (navigation catheter).
The modified Lee does not specifically show that the cylindrical housing of the control actuator extends over a length of the proximal end of the housing of the sheath actuator, and that the cylindrical housing is translatable and rotatable relative to the length of the proximal end of the housing.
Marino teaches a bone coring device/method involving a two handle design (see abstract; Fig. 1). Marino teaches that the first handle component 115 may be rotated relative to the second handle component 120, so as to cause movement between the outer cutting tube 125 and inner cutting tube 130 (see ¶[0021]-[0024], ¶[0032], and ¶[0037]-[0038]; Figs. 1 and 9). Here, the housing of the first handle component 115 would be considered to be the housing of the control actuator, and the housing of the second handle component 120 would be considered to be the housing of the sheath actuator. The cylindrical housing of the control actuator extends over a length of the proximal end of the housing of the sheath actuator (see Figs. 5B and 5D, the housing of the first handle extends over the proximal end of the housing of the second handle, it clearer shown on the top portion of each cross-sectional view in Figs. 5B and 5D). The control actuator rotatably and translatably surrounds a portion of the proximal end of the sheath actuator (see Figs. 5B and 5D, the first handle is rotatably/translatably relative to the length of the proximal end of the device, Figs. 5B and 5D). Furthermore, the pins 505 are not required to be used in the embodiment (see ¶[0023] and ¶[0030]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the physical arrangement of the two housings of the modified Lee with the physical arrangement of the two housing of Marino because (1) it is the simple substitution of one known element for another to yield predictable results and/or (2) the shape and arrangement of the two handles provide beneficial ergonomic features (see Marino ¶[0021]).
Alternatively and/or additionally, the alternate arrangement of Marino suggests that the arrangement between the housings of the control actuator and sheath actuator may be rearranged. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the two housings of the control actuator and the sheath actuator such that the cylindrical housing of the control actuator extends over a length of the proximal end of the housing of the sheath actuator and that the cylindrical housing is translatable and rotatable relative to the length of the proximal end of the housing because the rearrangement of the two housings would only require routine skill in the art that would have not affected the operation of the apparatus, and would merely be a matter of design choice (MPEP § 2144.04(VI)(C) citing In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975)). Furthermore, the applicant has not placed any criticality on this claimed recitation, as evidenced by lack of such criticality in the specification.
The modified Lee does not specifically teach how the control actuator is coupled over the proximal end of the housing, including that the control actuator is coupled such that rotation of the control actuator relative to the housing simultaneously advances and rotates the flexible drive shaft.
Janssens teaches a hand-held arrangement and driving mechanism for moving a plurality of tools independently of each other (see abstract and Fig. 1), in which the assembly comprises a cannula 200 (see ¶[0101]-[0102]; Figs. 1-2), a hollow biopsy needle 300 (see ¶[0101] and ¶[0103]; Figs. 1 and 3), and an inner needle 400 (see ¶[0101] and ¶[0105]; Figs. 1 and 4), in which the hollow biopsy needle 300 is threadably coupled to the cannula 200 via the screw thread 312 for engaging with the screw thread 212 of the inner side 211 of the cylindrical back end 210 of the cannula 200 (see ¶[0103]-[0104]; Figs. 1-3), and the inner needle 400 is threadably coupled to the hollow biopsy needle 300 via the screw head 412 for engaging with the screw thread 322 of the inner side 311 of the cylindrical back end 310 of the hollow biopsy needle 300 (see ¶[0107]; Figs. 1 and 3-4), so that the components are movable relative to one another when they are rotated relative to one another, which involves simultaneous advancement and rotation via the rotation of the inner needle 400 relative to the hollow biopsy needle 300 (see abstract, ¶[0026]-[0028], ¶[0062], ¶[0073], and ¶[0108]; Figs. 1-4).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a threaded coupling as taught by the threaded coupling of the inner needle 400 to the hollow biopsy needle 300 of Janssens with the control actuator and the housing of the modified Lee because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified Lee requires a coupling between the control actuator and the housing and Janssens teaches one such coupling; and/or (3) a threaded coupling between components is reliable and an easy to use form of coupling known in the art.
Regarding Claim 2, Lee in view of Voegele, Marino, and Janssens teaches the apparatus of claim 1 as stated above. Lee further teaches the flexible drive shaft defines therein a lumen fluidly coupled with the receiving chamber (¶[0188] the lumen of the coring component 1450; Fig. 14).
Regarding Claim 3, Lee in view of Voegele, Marino, and Janssens teaches the apparatus of claim 2 as stated above. Lee further teaches that the flexible drive shaft is configured to enable the lumen to slidably and removably receive therein a stylet extendable through the lumen to engage the tissue mass (¶[0085] a stiffening stylet is inserted/retracted through the catheter and/or the biopsy catheter acts as the stylet).
Regarding Claim 4, Lee in view of Voegele, Marino, and Janssens teaches the apparatus of claim 1 as stated above. Lee further teaches the cutting element includes a cutting surface inclined relative to the axis in a first rotational direction (¶[0189] the coring component may comprise different embodiments, multiple of which comprise at least one cutting surface inclined relative to the axis in a first rotational direction; see Figs. 7B-8C and 14).
Regarding Claim 7, Lee teaches a biopsy assembly (see abstract), which may include a handler region to be usable by a user (see ¶[0084]-[0085]; Figs. 4A-4B). Lee teaches a system (see abstract, the biopsy assembly) comprising:
a rotatable sampling element (¶[0188]-[0190] the coring component 1450 and the biopsy catheter 1404; Fig. 14) including:
a cylindrical body (¶[0188] the cylindrical body of the coring component 1450; Fig. 14) defining a receiving chamber (¶[0190] the interior of the coring component 1450 adjacent to the suction bay 1462 and/or the suction bay 1462; Fig. 14), the receiving chamber being configured to receive therein a tissue sample cut from a tissue mass (¶[0190] once the target tissue is parted off, the target tissue is aspirated into the suction bay 1462; Fig. 14); and
a cutting element disposed at a distal end of the cylindrical body to cut the tissue sample from the tissue mass abutting the distal end responsive to rotation of the cylindrical body as the cutting element is pressed against the tissue mass (¶[0188]-[0190] the coring component 1450 for parting off the target tissue, the coring component 1450 may take the embodiment of those described in Figs. 5-8C and 9A-9F, ¶[0016], ¶[0069], ¶[0084]-[0085], ¶[0103]-[0104], ¶[0112], ¶[0124], and ¶[0135] the various embodiments of the blade arrangement (the coring component) may be configured to rotate; Figs. 5-8C, 9A-9F, and 14);
a flexible drive shaft having a distal end fixably engaged with a proximal end of the rotatable sampling element (¶[0188]-[0190] the biopsy catheter 1404, ¶[0084]-[0085] the biopsy catheter is utilized in multiple embodiments, and is shown as being flexible, see curve in Fig. 4B; Figs. 4B and 14), the flexible drive shaft being linearly movable to motivate the rotatable sampling element along an axis to press the cutting element against the tissue mass and rotatable to impart rotational force to the rotatable sampling element to cause the rotatable sampling element to rotate around the axis (¶[0016], ¶[0069], and ¶[0084]-[0085] the proximal end of the biopsy catheter may be coupled to a catheter, the rotation of the handle causes the catheter to rotate, as the catheter is connected to the coring component, and the coring component is configured to rotate, the rotation of the handle would translate to the coring component; Fig. 14);
an actuator handle (¶[0084]-[0085] the control handle 434; Figs. 4A-4B) including:
a control actuator mechanically couplable with a proximal end of the flexible drive shaft to impart the rotational force and linear translational movement to the flexible drive shaft (¶[0084]-[0085] the control handle 434 allows for manual rotation and extension of the biopsy catheter through the catheter; Figs. 4A-4B and 14).
Lee is silent regarding that the actuator handle includes a sheath actuator including a cylindrical sleeve and a housing movable within the cylindrical sleeve, the housing coupled to a sheath and configured to enable advancement of the sheath relative to the actuator handle.
Voegele teaches biopsy methods/devices (see abstract; Figs. 1-3). Voegele teaches an actuator handle (col. 2 ln. 30-60, the handle 45; Fig. 1) including: a sheath actuator (col. 2 ln. 52-60, the outer sheath assembly 40; Fig. 1) including a cylindrical sleeve defining an annular channel that slidably receives the housing (see col. 4 ln. 4-20 and Figs.2a-2c, the sleeve 44 with the channel therewithin that slidably receives the cannular carrier 42), and a housing movable within the cylindrical sleeve (col. 3 ln. 8-35 and col. 4 ln. 4-20, the cannular carrier 42; Figs. 2a-2c), the housing coupled to the sheath (col. 3 ln. 21-35, the sheath is the cannula 14, the cannula 14 is disposed on a distal face of the carrier 42; Figs. 2a-2c) and configured to enable advancement of the sheath relative to the sleeve 44 (col. 4 ln. 4-20, the movement of the carrier 42 causes the cannula 14 to move; Figs. 2a-2c show the movement of the carrier 42 and the cannula 14 relative to the sleeve 44).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the sheath actuator of Voegele with the actuator handle of Lee because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the sheath actuator may allow the sampling port to be covered, which would prevent tissue from entering the sampling port during insertion/removal of the device (see Voegele col. 3 ln. 44-60); and/or (3) the sheath actuator would provide additional control to the sheath (navigation catheter) without the user needing to rely on movement of the handle 410 for movement of the sheath (navigation catheter), so that more minute movements of the sheath may be accomplished via the sheath actuator as compared to utilizing the handle 410. Here, the combination would include the sheath actuator being incorporated onto the handle 410 of the device of Lee, such that the sheath actuator of Voegele is utilized alongside the actuator handle 434 of Lee, wherein the sheath actuator controls the sheath of Lee and the control actuator still provides control to the biopsy catheter. Here, the sheath actuator would provide additional control to the sheath (navigation catheter) without the user needing to rely on movement of the handle 410 for movement of the sheath (navigation catheter). In this way, the user would instead utilize the actuator handle to move the sheath relative to the handle 410 so that more minute movements of the sheath may be accomplished via the sheath actuator as compared to utilizing the handle 410. In this way, the sheath actuator is incorporated onto the handle 410, alongside the handle 434, to provide the user with more control to the sheath (navigation catheter). As the handle 434 and the handle 410 may couple/uncouple (see Lee ¶[0084]); therefore, the sheath would be considered to move relative to the handle 410 and/or the handle 434.
The modified Lee does not specifically show that the control actuator rotatably and translatably surrounds and is coupled over a portion of a proximal end of the housing.
Marino teaches a bone coring device/method involving a two handle design (see abstract; Fig. 1). Marino teaches that the first handle component 115 may be rotated relative to the second handle component 120, so as to cause movement between the outer cutting tube 125 and inner cutting tube 130 (see ¶[0021]-[0024], ¶[0032], and ¶[0037]-[0038]; Figs. 1 and 9). Here, the first handle component 115 would be considered to be the control actuator, and the second handle component 120 would be considered to be the sheath actuator. The control actuator rotatably and translatably surrounds a portion of the proximal end of the sheath actuator (see Figs. 5B and 5D, the first handle rotatably/translatably surrounds over the proximal end of the second handle, it clearer shown on the top portion of each cross-sectional view in Figs. 5B and 5D). Furthermore, the pins 505 are not required to be used in the embodiment (see ¶[0023] and ¶[0030]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the physical arrangement of the two housings of the modified Lee with the physical arrangement of the two housing of Marino because (1) it is the simple substitution of one known element for another to yield predictable results and/or (2) the shape and arrangement of the two handles provide beneficial ergonomic features (see Marino ¶[0021]).
Alternatively and/or additionally, the alternate arrangement of Marino suggests that the arrangement between the control actuator and sheath actuator may be rearranged. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the control actuator and the sheath actuator such that the control actuator rotatably and translatably surrounds a portion of the proximal end of the sheath actuator because the rearrangement of the two actuators would only require routine skill in the art that would have not affected the operation of the system, and would merely be a matter of design choice (MPEP § 2144.04(VI)(C) citing In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975)). Furthermore, the applicant has not placed any criticality on this claimed recitation, as evidenced by lack of such criticality in the specification.
The modified Lee does not specifically teach how the control actuator is coupled over the proximal end of the housing, including that the control actuator is coupled such that rotation of the control actuator relative to the housing imparts rotational force and linear translation movement to the flexible drive shaft.
Janssens teaches a hand-held arrangement and driving mechanism for moving a plurality of tools independently of each other (see abstract and Fig. 1), in which the assembly comprises a cannula 200 (see ¶[0101]-[0102]; Figs. 1-2), a hollow biopsy needle 300 (see ¶[0101] and ¶[0103]; Figs. 1 and 3), and an inner needle 400 (see ¶[0101] and ¶[0105]; Figs. 1 and 4), in which the hollow biopsy needle 300 is threadably coupled to the cannula 200 via the screw thread 312 for engaging with the screw thread 212 of the inner side 211 of the cylindrical back end 210 of the cannula 200 (see ¶[0103]-[0104]; Figs. 1-3), and the inner needle 400 is threadably coupled to the hollow biopsy needle 300 via the screw head 412 for engaging with the screw thread 322 of the inner side 311 of the cylindrical back end 310 of the hollow biopsy needle 300 (see ¶[0107]; Figs. 1 and 3-4), so that the components are movable relative to one another when they are rotated relative to one another, which involves simultaneous advancement and rotation via the rotation of the inner needle 400 relative to the hollow biopsy needle 300 (see abstract, ¶[0026]-[0028], ¶[0062], ¶[0073], and ¶[0108]; Figs. 1-4).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a threaded coupling as taught by the threaded coupling of the inner needle 400 to the hollow biopsy needle 300 of Janssens with the control actuator and the housing of the modified Lee because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified Lee requires a coupling between the control actuator and the housing and Janssens teaches one such coupling; and/or (3) a threaded coupling between components is reliable and an easy to use form of coupling known in the art.
Regarding Claim 8, Lee in view of Voegele, Marino, and Janssens teaches the system of claim 7 as stated above. Lee further teaches the flexible drive shaft defines therein a lumen fluidly coupled with the receiving chamber (¶[0188] the lumen of the coring component 1450; Fig. 14) and a port defined by the actuator handle (¶[0188] a biopsy port may be utilized to apply suction through the suction tube 1460 to help secure the device to the target tissue and/or secure a portion of the sample within the device; Fig. 14).
Regarding Claim 12, Lee in view of Voegele, Marino, and Janssens teaches the system of claim 7 as stated above. Lee further teaches the cutting element includes at least one cutting surface inclined relative to the axis in a first rotational direction (¶[0189] the coring component may comprise different embodiments, multiple of which comprise at least one cutting surface inclined relative to the axis in a first rotational direction; see Figs. 7B-8C and 14).
Regarding Claim 16, Lee in view of Voegele, Marino, and Janssens teaches the system of claim 7 as stated above. The modified Lee further teaches the control actuator is configured to slide over a proximal end of the housing sleeve to motivate the flexible drive shaft to linearly move the rotatable sampling element relative to the tissue mass (see Lee ¶[0084]-[0085] the control handle 434 allows for manual rotation and extension of the biopsy catheter through the catheter, Figs. 4A-4B and 14; see Voegele col. 4 ln. 4-20, the movement of the carrier 42 causes the cannula 14 to move; Figs. 2a-2c show the movement of the carrier 42 and the cannula 14 relative to the apparatus; see Marino see Figs. 5B and 5D for the control actuator to slide over the housing).
Regarding Claim 17, Lee in view of Voegele, Marino, and Janssens teaches the system of claim 7 as stated above. Lee further teaches the sheath is configured to receive therein the rotatable sampling element and at least a portion of the flexible drive shaft and further configured to convey the rotatable sampling element adjacent the tissue mass (¶[0188]-[0190] the catheter 1402; Fig. 14).
Claims 5-6 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Voegele, Marino, and Janssens as applied to claims 1, 4, and 17, above, and in view of Herrin (US Patent Application Publication 2019/0290313 – cited in prior action), hereinafter Herrin.
Regarding Claim 5, Lee in view of Voegele, Marino, and Janssens teaches the apparatus of claim 4 as stated above. The modified Lee is silent regarding an additional rotatable sampling element including: a second cylindrical body concentrically disposed around the cylindrical body and supporting at least one additional cutting element at a distal end of the second cylindrical body, wherein the at least one additional cutting element includes at least one additional cutting surface inclined relative to the axis and facing an opposing rotational direction opposite to the first rotational direction, the cylindrical body being rotatable relative to the second cylindrical body to scissor the tissue mass between the cutting surface and the at least one additional cutting surface responsive to relative counter-rotation of the cylindrical body and the second cylindrical body; and an additional flexible drive shaft concentrically disposed around the flexible drive shaft and fixably engaged with a proximal end of the additional rotatable sampling element, wherein the additional flexible drive shaft is laterally movable with the flexible drive shaft and rotationally independent of the flexible drive shaft to enable the relative counter-rotation of the cylindrical body and the second cylindrical body.
Herrin teaches devices/methods for a biopsy apparatus including a counter-rotatable cutting apparatus, including a first and second drive shaft to engage the first and second cutting elements (see abstract; Figs. 1-2). Herrin teaches an additional rotatable sampling element (¶[0030] the two counter-rotatable members, the outer cutting member 251 would be considered the additional rotatable sampling element; Fig. 2) including:
a second cylindrical body concentrically disposed around the cylindrical body (¶[0030] and ¶[0034]-[0035] the body 455 of the outer cutting member 251; Figs. 2 and 4A-4C) and supporting at least one additional cutting element at a distal end of the second cylindrical body (¶[0030] and ¶[0034]-[0035] the outer cutting member 251; Figs. 2 and 4A-4C),
wherein the at least one additional cutting element includes at least one additional cutting surface inclined relative to the axis (¶[0034]-[0035] the outer cutting surface 271 and/or the cutting edge 473/475) and facing an opposing rotational direction opposite to the first rotational direction (¶[0030] and ¶[0035]-[0036] the cutting surfaces may be angled different to the axis, such that the tissue is scissored between the cutting surfaces when the cutting members are counter-rotated; Figs. 2-4C),
the cylindrical body being rotatable relative to the second cylindrical body to scissor the tissue mass between the cutting surface and the at least one additional cutting surface responsive to relative counter-rotation of the cylindrical body and the second cylindrical body (¶[0030] and ¶[0035]-[0036] the cutting surfaces may be angled different to the axis, such that the tissue is scissored between the cutting surfaces when the cutting members are counter-rotated; Figs. 2-4C); and
an additional flexible drive shaft concentrically disposed around the flexible drive shaft and fixably engaged with a proximal end of the additional rotatable sampling element (¶[0029] the drive shaft assembly 140, the additional flexible drive shaft would be the second drive shaft that is disposed around the first drive shaft; Fig. 1),
wherein the additional flexible drive shaft is laterally movable with the flexible drive shaft and rotationally independent of the flexible drive shaft to enable the relative counter-rotation of the cylindrical body and the second cylindrical body (¶[0030] and ¶[0035]-[0036] the cutting surfaces may be angled different to the axis, such that the tissue is scissored between the cutting surfaces when the cutting members are counter-rotated; Figs. 2-4C).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the additional rotating sampling element of Herrin with the rotating sampling element of the modified Lee because (1) it is the application of a known technique with a known device ready for improvement to yield predictable results and/or (2) the scissoring of tissue achieved by the counter-rotatable design would allow for an easier cut to be made than punching through the tissue, if the tissue is too pliable (see Herrin ¶[0005]).
Regarding Claim 6, Lee in view of Voegele, Marino, and Janssens teaches the apparatus of claim 1 as stated above. The modified Lee is silent regarding the sheath actuator includes a locking device, the locking device extending through a channel defined in a wall of the cylindrical sleeve and threadably received by a threaded recess defined in the housing, wherein the locking device is configured to engage one or more sides of the channel when tightened to fix a position of the housing relative to the cylindrical sleeve and to disengage from the one or more sides of the channel when loosened to permit sliding of the housing relative to the cylindrical sleeve.
Herrin teaches devices/methods for a biopsy apparatus including a counter-rotatable cutting apparatus, including a first and second drive shaft to engage the first and second cutting elements (see abstract; Figs. 1-2). Herrin teaches the sheath actuator includes a locking device to fix a position of the housing relative to the cylindrical sleeve once the sheath is in a desired position relative to the tissue mass (¶[0041]-[0042] the sheath lock 776 for locking the drive shaft assembly once the cutting apparatus has been placed at a desired location; Figs. 7-8),
the locking device extending through a channel defined in a wall of the cylindrical sleeve (¶[0041]-[0042] the sheath lock 776 is received through the sheath locking port 778 in the housing 160; Figs. 7-8) and
threadably received by a threaded recess defined in the housing (¶[0041]-[0042] the sleeve 772 includes a locking groove 777 that receives the sheath lock 776, the sheath lock 776 may be in the form of a knurled lock screw that mechanically and selectively engages the locking groove 777 in the sleeve 772, a knurled lock screw necessarily has threads, which if received by a selective engagement would necessarily be a threaded recess for receiving the threads of the screw; Figs. 7-8),
wherein the locking device is configured to engage one or more sides of the channel when tightened to fix a position of the housing relative to the cylindrical sleeve and to disengage from the one or more sides of the channel when loosened to permit sliding of the housing relative to the cylindrical sleeve (¶[0041]-[0042] once the cutting apparatus 111 has been positioned at a desired location, the sheath lock 776 may be turned to cause the sheath lock 776 to engage the locking groove 777 in the sleeve 772 to lock the drive shaft assembly 140 and, thus, the cutting apparatus 111 coupled with drive shaft assembly 140 at a desired location; Figs. 7-8).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the sheath lock of Herrin with the device of the modified Lee because (1) it is the application of a known technique with a known device ready for improvement to yield predictable results and/or (2) it would help the medical professional (the user) keep the device in position, once the cutting apparatus is positioned at a desired position (see Herrin ¶[0042]).
Regarding Claim 18, Lee in view of Voegele, Marino, and Janssens teaches the system of claim 17 as stated above. The modified Lee is silent regarding the sheath actuator includes a locking device, the locking device extending through a channel defined in a wall of the cylindrical sleeve and threadably received by a threaded recess defined in the housing, wherein the locking device is configured to engage one or more sides of the channel when tightened to fix a position of the housing relative to the cylindrical sleeve and to disengage from the one or more sides of the channel when loosened to permit sliding of the housing relative to the cylindrical sleeve.
Herrin teaches devices/methods for a biopsy apparatus including a counter-rotatable cutting apparatus, including a first and second drive shaft to engage the first and second cutting elements (see abstract; Figs. 1-2). Herrin teaches the sheath actuator includes a locking device to fix a position of the housing relative to the cylindrical sleeve once the sheath is in a desired position relative to the tissue mass (¶[0041]-[0042] the sheath lock 776 for locking the drive shaft assembly once the cutting apparatus has been placed at a desired location; Figs. 7-8),
the locking device extending through a channel defined in a wall of the cylindrical sleeve (¶[0041]-[0042] the sheath lock 776 is received through the sheath locking port 778 in the housing 160; Figs. 7-8) and
threadably received by a threaded recess defined in the housing (¶[0041]-[0042] the sleeve 772 includes a locking groove 777 that receives the sheath lock 776, the sheath lock 776 may be in the form of a knurled lock screw that mechanically and selectively engages the locking groove 777 in the sleeve 772, a knurled lock screw necessarily has threads, which if received by a selective engagement would necessarily be a threaded recess for receiving the threads of the screw; Figs. 7-8),
wherein the locking device is configured to engage one or more sides of the channel when tightened to fix a position of the housing relative to the cylindrical sleeve and to disengage from the one or more sides of the channel when loosened to permit sliding of the housing relative to the cylindrical sleeve (¶[0041]-[0042] once the cutting apparatus 111 has been positioned at a desired location, the sheath lock 776 may be turned to cause the sheath lock 776 to engage the locking groove 777 in the sleeve 772 to lock the drive shaft assembly 140 and, thus, the cutting apparatus 111 coupled with drive shaft assembly 140 at a desired location; Figs. 7-8).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the sheath lock of Herrin with the device of the modified Lee because (1) it is the application of a known technique with a known device ready for improvement to yield predictable results and/or (2) it would help the medical professional (the user) keep the device in position, once the cutting apparatus is positioned at a desired position (see Herrin ¶[0042]).
Regarding Claim 19, Lee teaches a biopsy assembly (see abstract), which may include a handler region to be usable by a user (see ¶[0084]-[0085]; Figs. 4A-4B). Lee teaches a method (see abstract, the biopsy assembly) comprising:
positioning a rotatable sampling element adjacent a tissue mass (¶[0016], ¶[0069], ¶[0084]-[0085], and ¶[0188]-[0190] the proximal end of the biopsy catheter may be coupled to a catheter, the rotation of the handle causes the catheter to rotate, as the catheter is connected to the coring component, and the coring component is configured to rotate, the rotation of the handle would translate to the coring component, adjacent to the target tissue; Fig. 14) including
manipulating a control actuator including sliding the control actuator to translate the rotatable sampling element within the sheath (¶[0084]-[0085] the control handle 434 allows for manual rotation and extension of the biopsy catheter through the catheter; Figs. 4A-4B and 14),
wherein the control actuator includes a cylindrical housing (¶[0084]-[0085] the handle body, note while 430 appears to be associated with the handle body, this should be associated with the handle base as also stated by Lee; Figs. 4A-4B),
advancing and rotating, using the control actuator, the rotatable sampling element (¶[0016], ¶[0069], ¶[0084]-[0085], and ¶[0188]-[0190] the proximal end of the biopsy catheter may be coupled to a catheter, the rotation of the handle causes the catheter to rotate, as the catheter is connected to the coring component, and the coring component is configured to rotate, the rotation of the handle would translate to the coring component, adjacent to the target tissue; Fig. 14) such that a cutting apparatus cuts a tissue sample from the tissue mass (¶[0188]-[0190] the coring component 1450 for parting off the target tissue, the coring component 1450 may take the embodiment of those described in Figs. 5-8C and 9A-9F, ¶[0016], ¶[0069], ¶[0084]-[0085], ¶[0103]-[0104], ¶[0112], ¶[0124], and ¶[0135] the various embodiments of the blade arrangement (the coring component) may be configured to rotate; Figs. 5-8C, 9A-9F, and 14),
wherein the cutting apparatus includes one or more piercing ends (¶[0132]-[0135] the cutting edges 795 of the blades 791; Fig. 7D) and one or more lateral cutting edges, each lateral cutting edge angling away from a respective one of the one or more piercing ends (¶[0132]-[0135] the lateral cutting edge blades 798 of the blades 791, the lateral cutting edge blades 798 are angled away from the blades 791; Fig. 7D) and extending along a slot defined by the cylindrical body toward the distal end (¶[0132]-[0135] the elongate slits 792 for separating the blades 791; Fig. 7D) such that the one or more piercing ends slice into the tissue mass and the one or more lateral cutting edges further cut into the tissue mass as the rotatable sampling element is advanced (see ¶[0132]-[0135] and Fig. 7D, the lateral cutting edge blades 798 would further cut into the tissue as the cutting apparatus is advanced, the functional language is further met as the structure as required in the claim to perform such function is met); and
removably receiving the tissue sample into a receiving chamber (¶[0190] the interior of the coring component 1450 adjacent to the suction bay 1462 and/or the suction bay 1462, once the target tissue is parted off, the target tissue is aspirated into the suction bay 1462; Fig. 14).
Lee is silent regarding that manipulating a sheath actuator including sliding a housing relative to a sleeve to translate a sheath coupled to the housing adjacent the tissue mass.
Voegele teaches biopsy methods/devices (see abstract; Figs. 1-3). Voegele teaches an actuator handle (col. 2 ln. 30-60, the handle 45; Fig. 1) including: a sheath actuator (col. 2 ln. 52-60, the outer sheath assembly 40; Fig. 1) including a cylindrical sleeve (see Figs.2a-2c, the sleeve 44) and a housing movable within the sleeve (col. 3 ln. 8-35 and col. 4 ln. 4-20, the cannular carrier 42; Figs. 2a-2c), the housing coupled to the sheath (col. 3 ln. 21-35, the sheath is the cannula 14, the cannula 14 is disposed on a distal face of the carrier 42; Figs. 2a-2c) and configured to enable advancement of the sheath relative to the apparatus (col. 4 ln. 4-20, the movement of the carrier 42 causes the cannula 14 to move; Figs. 2a-2c show the movement of the carrier 42 and the cannula 14 relative to the apparatus).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the sheath actuator of Voegele with the method of Lee because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) the sheath actuator may allow the sampling port to be covered, which would prevent tissue from entering the sampling port during insertion/removal of the device (see Voegele col. 3 ln. 44-60); and/or (3) the sheath actuator would provide additional control to the sheath (navigation catheter) without the user needing to rely on movement of the handle 410 for movement of the sheath (navigation catheter), so that more minute movements of the sheath may be accomplished via the sheath actuator as compared to utilizing the handle 410. Here, the combination would include the sheath actuator being incorporated onto the handle 410 of the device of Lee, such that the sheath actuator of Voegele is utilized alongside the actuator handle 434 of Lee, wherein the sheath actuator controls the sheath of Lee and the control actuator still provides control to the biopsy catheter. Here, the sheath actuator would provide additional control to the sheath (navigation catheter) without the user needing to rely on movement of the handle 410 for movement of the sheath (navigation catheter). In this way, the user would instead utilize the actuator handle to move the sheath relative to the handle 410 so that more minute movements of the sheath may be accomplished via the sheath actuator as compared to utilizing the handle 410. In this way, the sheath actuator is incorporated onto the handle 410, alongside the handle 434, to provide the user with more control to the sheath (navigation catheter).
The modified Lee does not specifically show that the cylindrical housing of the control actuator extends over a length of the proximal end of the housing of the sheath actuator.
Marino teaches a bone coring device/method involving a two handle design (see abstract; Fig. 1). Marino teaches that the first handle component 115 may be rotated relative to the second handle component 120, so as to cause movement between the outer cutting tube 125 and inner cutting tube 130 (see ¶[0021]-[0024], ¶[0032], and ¶[0037]-[0038]; Figs. 1 and 9). Here, the housing of the first handle component 115 would be considered to be the housing of the control actuator, and the housing of the second handle component 120 would be considered to be the housing of the sheath actuator. The cylindrical housing of the control actuator extends over a length of the proximal end of the housing of the sheath actuator (see Figs. 5B and 5D, the housing of the first handle extends over the proximal end of the housing of the second handle, it clearer shown on the top portion of each cross-sectional view in the figures). Furthermore, the pins 505 are not required to be used in the embodiment (see ¶[0023] and ¶[0030]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the physical arrangement of the two housings of the modified Lee with the physical arrangement of the two housing of Marino because (1) it is the simple substitution of one known element for another to yield predictable results and/or (2) the shape and arrangement of the two handles provide beneficial ergonomic features (see Marino ¶[0021]).
Alternatively and/or additionally, the alternate arrangement of Marino suggests that the arrangement between the housings of the control actuator and sheath actuator may be rearranged. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the two housings of the control actuator and the sheath actuator such that the cylindrical housing of the control actuator extends over a length of the proximal end of the housing of the sheath actuator because the rearrangement of the two housings would only require routine skill in the art that would have not affected the operation of the apparatus, and would merely be a matter of design choice (MPEP § 2144.04(VI)(C) citing In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975)). Furthermore, the applicant has not placed any criticality on this claimed recitation, as evidenced by lack of such criticality in the specification.
The modified Lee does not specifically teach how the control actuator is coupled over the proximal end of the housing, including that the control actuator is coupled for advancing and rotating.
Janssens teaches a hand-held arrangement and driving mechanism for moving a plurality of tools independently of each other (see abstract and Fig. 1), in which the assembly comprises a cannula 200 (see ¶[0101]-[0102]; Figs. 1-2), a hollow biopsy needle 300 (see ¶[0101] and ¶[0103]; Figs. 1 and 3), and an inner needle 400 (see ¶[0101] and ¶[0105]; Figs. 1 and 4), in which the hollow biopsy needle 300 is threadably coupled to the cannula 200 via the screw thread 312 for engaging with the screw thread 212 of the inner side 211 of the cylindrical back end 210 of the cannula 200 (see ¶[0103]-[0104]; Figs. 1-3), and the inner needle 400 is threadably coupled to the hollow biopsy needle 300 via the screw head 412 for engaging with the screw thread 322 of the inner side 311 of the cylindrical back end 310 of the hollow biopsy needle 300 (see ¶[0107]; Figs. 1 and 3-4), so that the components are movable relative to one another when they are rotated relative to one another, which involves simultaneous advancement and rotation via the rotation of the inner needle 400 relative to the hollow biopsy needle 300 (see abstract, ¶[0026]-[0028], ¶[0062], ¶[0073], and ¶[0108]; Figs. 1-4).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a threaded coupling as taught by the threaded coupling of the inner needle 400 to the hollow biopsy needle 300 of Janssens with the control actuator and the housing of the modified Lee because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) the modified Lee requires a coupling between the control actuator and the housing and Janssens teaches one such coupling; and/or (3) a threaded coupling between components is reliable and an easy to use form of coupling known in the art.
The modified Lee is silent regarding locking the housing relative to the sleeve using a locking device threadably coupled to the sleeve to engage a locking channel on the housing.
Herrin teaches devices/methods for a biopsy apparatus including a counter-rotatable cutting apparatus, including a first and second drive shaft to engage the first and second cutting elements (see abstract; Figs. 1-2). Herrin teaches the sheath actuator includes a locking device to fix a position of the housing relative to the cylindrical sleeve once the sheath is in a desired position relative to the tissue mass (¶[0041]-[0042] the sheath lock 776 for locking the drive shaft assembly once the cutting apparatus has been placed at a desired location; Figs. 7-8),
the locking device extending through a channel defined in a wall of the cylindrical sleeve (¶[0041]-[0042] the sheath lock 776 is received through the sheath locking port 778 in the housing 160; Figs. 7-8) and
threadably received by a threaded recess defined in the housing (¶[0041]-[0042] the sleeve 772 includes a locking groove 777 that receives the sheath lock 776, the sheath lock 776 may be in the form of a knurled lock screw that mechanically and selectively engages the locking groove 777 in the sleeve 772, a knurled lock screw necessarily has threads, which if received by a selective engagement would necessarily be a threaded recess for receiving the threads of the screw; Figs. 7-8),
wherein the locking device is configured to engage one or more sides of the channel when tightened to fix a position of the housing relative to the cylindrical sleeve and to disengage from the one or more sides of the channel when loosened to permit sliding of the housing relative to the cylindrical sleeve (¶[0041]-[0042] once the cutting apparatus 111 has been positioned at a desired location, the sheath lock 776 may be turned to cause the sheath lock 776 to engage the locking groove 777 in the sleeve 772 to lock the drive shaft assembly 140 and, thus, the cutting apparatus 111 coupled with drive shaft assembly 140 at a desired location; Figs. 7-8).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the sheath lock of Herrin with the device of the modified Lee because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) it would help the medical professional (the user) keep the device in position, once the cutting apparatus is positioned at a desired position (see Herrin ¶[0042]).
Regarding Claim 20, Lee in view of Voegele, Marino, Janssens, and Herrin teaches the method of claim 19 as stated above. The modified Lee is silent regarding further comprising: positioning an outer rotatable sampling element circumferentially around the rotatable sampling element adjacent to the tissue mass; and counter-rotating the rotatable sampling element and the outer rotatable sampling element to cut the tissue sample from the tissue mass.
Herrin further teaches positioning an outer rotatable sampling element circumferentially around the rotatable sampling element adjacent to the tissue mass (¶[0030] the two counter-rotatable members, the outer cutting member 251 would be considered the outer rotatable sampling element; Fig. 2); and
counter-rotating the rotatable sampling element and the outer rotatable sampling element to cut the tissue sample from the tissue mass (¶[0030] and ¶[0035]-[0036] the cutting surfaces may be angled different to the axis, such that the tissue is scissored between the cutting surfaces when the cutting members are counter-rotated; Figs. 2-4C).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the outer rotating sampling element of Herrin with the rotating sampling element of the modified Lee because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) the scissoring of tissue achieved by the counter-rotatable design would allow for an easier cut to be made than punching through the tissue, if the tissue is too pliable (see Herrin ¶[0005]).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Voegele, Marino, and Janssens as applied to claim 8 above, and in view of Klein (WIPO Publication WO 2019/155472 – cited in prior action), hereinafter Klein.
Regarding Claim 9, Lee in view of Voegele, Marino, and Janssens teaches the system of claim 8 as stated above. Lee further teaches that the flexible drive shaft is configured to enable the lumen to slidably and removably receive therein a stylet extendable through the lumen to engage the tissue mass (¶[0085] a stiffening stylet may be inserted/retracted through the catheter and/or the biopsy catheter may act as the stylet).
The modified Lee is silent regarding that the stylet may be slidably and removably received by the port.
Klein teaches a soft tissue biopsy device including a handle and an elongated flexible shaft configured to rotate and a sampling portion (see abstract; Fig. 1). Klein teaches that the biopsy guide 1602 may comprise a fluid line connector 1620, which would be considered the port (see pg. 68 ln. 24-30; Fig. 16A), in which a stylet may be configured to move through the device, including through the fluid line connector 1620 and the sampling portion, and may extend beyond the distal end of the shaft, so as to support the shaft as the shaft advances to the target tissue (see pg. 26 ln. 9-25 and pg. 67 ln. 16-21; Figs. 16A and 17I-17J).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the stylet slidably and removably received as in Klein with the system of the modified Lee because (1) it is the application of a known technique with a known device ready for improvement to yield predictable results and/or (2) the stylet would help to increase rigidity of the shaft (see Klein pg. 26 ln. 9-25 and pg. 67 ln. 16-21).
Regarding Claim 10, Lee in view of Voegele, Marino, Janssens, and Klein teaches the system of claim 9 as stated above. The modified Lee further teaches the lumen is slidable along the stylet to guide the rotatable sampling element to the tissue mass (see Klein pg. 26 ln. 9-25 and pg. 67 ln. 16-21 a stylet may be configured to move through the device, including through the fluid line connector 1620 and the sampling portion, and may extend beyond the distal end of the shaft, so as to support the shaft as the shaft advances to the target tissue; Figs. 16A and 17I-17J).
Regarding Claim 11, Lee in view of Voegele, Marino, Janssens, and Klein teaches the system of claim 9 as stated above. Lee further teaches the port is configured to receive a vacuum source configured to apply suction to the port and the lumen (¶[0188] a biopsy port may be utilized to apply suction through the suction tube 1460 to help secure the device to the target tissue and/or secure a portion of the sample within the device; Fig. 14).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Voegele, Marino, Janssens, and Klein as applied to claim 11 above, and in view of Herrin.
Regarding Claim 13, Lee in view of Voegele, Marino, Janssens, and Klein teaches the system of claim 11 as stated above. The modified Lee is silent regarding an additional rotatable sampling element including: an outer cylindrical body concentrically disposed around the cylindrical body and supporting an outer cutting element at a distal end of the outer cylindrical body, wherein the cutting element is disposed within the outer cutting element and includes at least one additional cutting surface inclined relative to the axis and facing an opposing rotational direction opposite to a first rotational direction, the cylindrical body being rotatable relative to the outer cylindrical body to scissor the tissue mass between a cutting surface and the at least one additional cutting surface responsive to relative counter-rotation of the cylindrical body and the outer cylindrical body; and an outer flexible drive shaft concentrically disposed around the flexible drive shaft and fixably engaged with a proximal end of the additional rotatable sampling element, wherein the outer flexible drive shaft is laterally movable with the flexible drive shaft and rotationally movable within the flexible drive shaft to enable the relative counter-rotation of the cylindrical body and the outer cylindrical body.
Herrin teaches devices/methods for a biopsy apparatus including a counter-rotatable cutting apparatus, including a first and second drive shaft to engage the first and second cutting elements (see abstract; Figs. 1-2). Herrin teaches an additional rotatable sampling element (¶[0030] the two counter-rotatable members, the outer cutting member 251 would be considered the additional rotatable sampling element; Fig. 2) including:
an outer cylindrical body concentrically disposed around the cylindrical body (¶[0030] and ¶[0034]-[0035] the body 455 of the outer cutting member 251; Figs. 2 and 4A-4C) and supporting an outer cutting element at a distal end of the outer cylindrical body (¶[0030] and ¶[0034]-[0035] the outer cutting member 251; Figs. 2 and 4A-4C),
wherein the cutting element is disposed within the outer cutting element (¶[0034]-[0035] the inner cutting member 211 is disposed within the outer cutting member 251; Fig. 2) and includes at least one additional cutting surface inclined relative to the axis (¶[0034]-[0035] the outer cutting surface 271 and/or the cutting edge 473/475) and facing an opposing rotational direction opposite to the first rotational direction (¶[0030] and ¶[0035]-[0036] the cutting surfaces may be angled different to the axis, such that the tissue is scissored between the cutting surfaces when the cutting members are counter-rotated; Figs. 2-4C),
the cylindrical body being rotatable relative to the outer cylindrical body to scissor the tissue mass between the cutting surface and the at least one additional cutting surface responsive to relative counter-rotation of the cylindrical body and the second cylindrical body (¶[0011] and ¶[0038] the first actuator rotates in a first direction and the second actuator rotates in a second direction, thus, the counter-rotation occurs in opposite directions, ¶[0045]-[0048] the counter-rotating mechanism 802/902 for implementing the counter-rotation, the counter-rotating mechanism 902 may be configured to rotate the two different shafts at different speeds, ¶[0030] and ¶[0035]-[0036] the cutting surfaces may be angled different to the axis, such that the tissue is scissored between the cutting surfaces when the cutting members are counter-rotated; Figs. 2-4C, 6, and 8-9); and
an outer flexible drive shaft concentrically disposed around the flexible drive shaft and fixably engaged with a proximal end of the additional rotatable sampling element (¶[0029] the drive shaft assembly 140, the additional flexible drive shaft would be the second drive shaft that is disposed around the first drive shaft; Fig. 1),
wherein the outer flexible drive shaft is laterally movable with the flexible drive shaft and rotationally moveable within the flexible drive shaft to enable the relative counter-rotation of the cylindrical body and the outer cylindrical body (¶[0030] and ¶[0035]-[0036] the cutting surfaces may be angled different to the axis, such that the tissue is scissored between the cutting surfaces when the cutting members are counter-rotated; Figs. 2-4C).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the additional rotating sampling element of Herrin with the rotating sampling element of the modified Lee because (1) it is the application of a known technique with a known device ready for improvement to yield predictable results and/or (2) the scissoring of tissue achieved by the counter-rotatable design would allow for an easier cut to be made than punching through the tissue, if the tissue is too pliable (see Herrin ¶[0005]).
Regarding Claim 14, Lee in view of Voegele, Marino, Janssens, Klein, and Herrin teaches the system of claim 13 as stated above. The modified Lee further teaches the actuator handle is configured to prevent the outer flexible drive shaft from rotating while the flexible drive shaft is rotated to enable the flexible drive shaft to rotate independently of the outer flexible drive shaft (see Herrin ¶[0012] the independent rotation of the shafts, ¶[0048] the counter-rotating mechanism 902 may be configured to rotate the two different shafts at different speeds, such that each shaft is rotating at its own speed). Here, as the two shafts may be configured to rotate at different speeds, one shaft may be configured to rotate at a positive speed, and the other shaft may be configured to not move (a speed of zero), which meets the claimed recitation.
Regarding Claim 15, Lee in view of Voegele, Marino, Janssens, Klein, and Herrin teaches the system of claim 13 as stated above. The modified Lee further teaches the actuator handle includes a counter-rotating mechanism mechanically couplable with the flexible drive shaft and the outer flexible drive shaft (see Herrin ¶[0045]-[0046] the counter-rotating mechanism 802/902; Figs. 8-9), wherein the counter-rotating mechanism is configured to cause the flexible drive shaft to rotate in a first direction while the outer flexible drive shaft is rotated in an opposite direction (see Herrin ¶[0011] and ¶[0038] the first actuator rotates in a first direction and the second actuator rotates in a second direction, thus, the counter-rotation occurs in opposite directions, ¶[0045]-[0046] the counter-rotating mechanism 802/902 for implementing the counter-rotation; Figs. 6 and 8-9).
Response to Arguments
Applicant’s arguments, objections to the drawings
Applicant’s arguments, see pg. 8, filed July 19, 2026, with respect to the objections to the drawings under 37 CFR 1.83(a) have been fully considered and are persuasive. Therefore, the objections have been withdrawn.
Applicant’s arguments, 35 U.S.C. § 103
Applicant’s arguments, see pg. 8-11, filed July 19, 2026, with respect to the rejections of claims 1-3 under 35 U.S.C. § 103 have been fully considered and are NOT persuasive. Applicant argued that the cited references to not teach the specific cutting geometry as recited in the amended claims. The examiner respectfully disagrees. As explained above, Lee teaches a cutting element disposed at a distal end of the cylindrical body to cut the tissue sample from the tissue mass abutting the distal end responsive to rotation of the cylindrical body as the cutting element is pressed against the tissue mass (¶[0188]-[0190] the coring component 1450 for parting off the target tissue, the coring component 1450 may take the embodiment of those described in Figs. 5-8C and 9A-9F, ¶[0016], ¶[0069], ¶[0084]-[0085], ¶[0103]-[0104], ¶[0112], ¶[0124], and ¶[0135] the various embodiments of the blade arrangement (the coring component) may be configured to rotate; Figs. 5-8C, 9A-9F, and 14),
wherein the cutting element includes one or more piercing ends (¶[0132]-[0135] the cutting edges 795 of the blades 791; Fig. 7D) and one or more lateral cutting edges, each lateral cutting edge angling away from a respective one of the one or more piercing ends (¶[0132]-[0135] the lateral cutting edge blades 798 of the blades 791, the lateral cutting edge blades 798 are angled away from the blades 791; Fig. 7D) and extending along a slot defined by the cylindrical body toward the distal end (¶[0132]-[0135] the elongate slits 792 for separating the blades 791; Fig. 7D). Therefore, Applicant’s arguments are not persuasive and the rejections to the claims under 35 U.S.C. § 103 are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN D. MORONESO whose telephone number is (571)272-8055. The examiner can normally be reached M-F: 8:30AM - 6:00 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER M. ROBERTSON can be reached at (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
