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 Arguments
Applicant’s arguments with respect to claim(s) 21, 22-25, 27, 28, 30-32, 33, 35, 36, 37, 39 and 40 have been considered but are moot because the new ground of rejection over Dubois et al. US 2015/0150580 in view of Daniel et al. US 5437630 and further in view of Kieturakis US 5794626.
Kieturakis teaches an axial adjustment coupling that coupled to the proximal member end of the cutting member and securing the cutting member relative to the shaft to allow cutting member to longitudinally move along a longitudinal axis thereof for maintaining alignment between the shaft window opening and the cutting window opening during use, the axial adjustment coupling having a spline coupling that simultaneously allows for longitudinal translation of the proximal member end relative to a drive output gear for maintaining the predetermined longitudinal distance (figures 5-9, proximal end of stem 85 includes a female spline receiving fitting 92, to engage a cooperating fitting in a motor, and a compression spring 93 which urges the stem and cutter 10 from engagement with the motor and actuator). Therefore, it would have been obvious to one having ordinary skill in the art to further provide an axial adjustment coupling including a spring and a spline, as taught by Kieturakis and known in the art, to provide a shaft with a slidable means for adjustment or longitudinal translation as required to maintain a desired distance between components.
Claim Rejections - 35 USC § 103
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.
Claim(s) 21, 22-25, 27, 28, 30-32, 33, 35, 36, 37, 39 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dubois et al. US 2015/0150580 in view of Daniel et al. US 5437630 and further in view of Kieturakis US 5794626.
Regarding claims 21, 22, 30-33, 35, 36, 37, 39 and 40, Dubois et al. discloses a method of using a surgical instrument 10 to treat a tissue within a nasal cavity of a patient (paragraphs 0090, 0094), inserting the surgical instrument into the nasal cavity (paragraphs 0090, 0094), the surgical instrument including: a shaft 12 having: a distal shaft end (figure 1G), a proximal shaft end (attached to chamber 20, figure 1A), a shaft sidewall extending from the distal shaft end to the proximal shaft end relative to the proximal shaft end (figure 1B, wall of shaft 12), and a shaft window 16 opening extending through the shaft sidewall (figure 1G); a cutting member 18 disposed within the shaft (figure 1G, may be various shapes or configurations, paragraph 0068) and having: a distal member end (within distal end of shaft 12, figure 1G), a proximal member end (opposite end within proximal end of shaft), a member sidewall extending from the distal member end to the proximal member end (wall of shaft 18, figure 1G), the method comprising: articulating the shaft and the cutting member from a first configuration towards a second configuration (paragraph 0067, malleable portion of the elongate shaft may be adjusted or manipulated before or during operation into various configurations ranging from straight to angled, or curved); moving the cutting member with a cyclical movement (paragraph 0006, rotating cutter, unidirectional or oscillating); maintaining a predetermined longitudinal distance between the distal member end and the distal shaft end before, during, and after the step of articulating (rotational motion of a cutter would provide a constant longitudinal distance between the distal member end and the distal shaft end, as opposed to a reciprocating cutter which would vary in distance, Examiner further notes that no space or gap is required between the member and shaft ends, a longitudinal distance would still exist between the members).
Dubois et al. fails to explicitly disclose a cutting window opening extending through the member sidewall of the cutting member or an axial adjustment coupling longitudinally securing the shaft relative to the cutting member, the axial adjustment coupling being proximally located relative to the proximal member end including a resilient member, the resilient member including a spring, further biasing the distal member end towards the distal shaft end and longitudinally compressing the spring to allow the distal member end to move in a proximal direction relative to the proximal shaft end to perform the act of maintaining the predetermined longitudinal distance between the distal member end and the distal shaft end while simultaneously articulating the shaft and the cutting member from the first configuration toward the second configuration, further comprising maintaining an alignment of the cutting window opening with the shaft window opening simultaneously while performing the act of articulating the shaft and the cutting member from the straight configuration towards the articulated configuration, or an axial adjustment coupling that coupled to the proximal member end of the cutting member and securing the cutting member relative to the shaft to allow cutting member to longitudinally move along a longitudinal axis thereof for maintaining alignment between the shaft window opening and the cutting window opening during use, the axial adjustment coupling having a spline coupling that simultaneously allows for longitudinal translation of the proximal member end relative to a drive output gear for maintaining the predetermined longitudinal distance.
Daniel et al. discloses a surgical instrument (figure 1) having a shaft 13 having a shaft sidewall and window 41 (figure 3) and a cutting member disposed within the shaft (figure 3, rotatable inner member 30 with nose 72 and cutting edge 42), a cutting window opening 80 extending through the member sidewall (column 9, lines 2-9, figure 3, path 46 E from the surgical site through the outer member and into the central bore of the head through bore 73 and window 41 and mouth 80 to cut tissue) to allow for orientation with the tissue site to be cut, the bits of removed tissues may be removed through the window from the surgical site (column 6, lines 3-17) and an axial adjustment coupling longitudinally securing the shaft (coupled within handpiece HP, figure 2), the axial adjustment coupling being proximally located relative to the proximal member end including a resilient member (figure 2, spring 35) the axial adjustment coupling being configured to maintain a predetermined longitudinal distance between the shaft end and the distal member end while the shaft is in the first configuration and while the shaft is in the second configuration (column 5, lines 46-column 6, line 2; compression spring 35 to properly align the outer member and cutting edge to maintain a relative axial position; Examiner notes that no space or gap is required, and there is still a distance between the outer wall surface of the shaft, or the distal most point, and the outer surface of the distal member end, the predetermined distance being the thickness of the wall of the shaft in this example, even though the distance is not defined with a gap or space therebetween), the axial adjustment coupling being proximally located relative to a proximal member end (spring 35 and coupling is at proximal end of shaft and inner member 30, figure 2), the axial adjustment coupling including a resilient member including a spring (spring 35, figure 2) for maintaining the relative axial position (column 5, lines 46-column 6, line 2) and spring positioned proximal of the proximal shaft end (spring 35 and coupling is at proximal end of shaft and inner member 30, figure 2), further comprising biasing the distal member end (nose 72 of distal tip portion 40) towards the distal shaft end 43 and compressing the spring to allow the distal member end to move in a proximal direction relative to the proximal shaft end to perform the act of maintaining the predetermined longitudinal distance between the distal member end 40 and the distal shaft end 43 (column 5, lines 46-57; spring 35 compresses to push the inner distal member end against the distal shaft end 11), further comprising maintaining an alignment of the cutting window opening with the shaft window opening simultaneously while performing the act of articulating the shaft and the cutting member from the straight configuration towards the articulated configuration (column 5, lines 58-61; to accurately position the inner tip portion with the outer tip portion and aligning the outer member window with the cutting edge and distal tip which maintains the proper relative axial position therebetween during cutting). Examiner notes a spring by nature would act to maintain an equilibrium, going back and forth between absorbing proximally directed compressive force and pushing against that force to maintain the bias towards the distal direction and maintaining the proper positioning even without an explicit teaching of “compressing the spring”. Daniel et al. fails to disclose an axial adjustment coupling that coupled to the proximal member end of the cutting member and securing the cutting member relative to the shaft to allow cutting member to longitudinally move along a longitudinal axis thereof for maintaining alignment between the shaft window opening and the cutting window opening during use, the axial adjustment coupling having a spline coupling that simultaneously allows for longitudinal translation of the proximal member end relative to a drive output gear for maintaining the predetermined longitudinal distance.
Kieturakis teaches an axial adjustment coupling that coupled to the proximal member end of the cutting member and securing the cutting member relative to the shaft to allow cutting member to longitudinally move along a longitudinal axis thereof for maintaining alignment between the shaft window opening and the cutting window opening during use, the axial adjustment coupling having a spline coupling that simultaneously allows for longitudinal translation of the proximal member end relative to a drive output gear for maintaining the predetermined longitudinal distance (figures 5-9, proximal end of stem 85 includes a female spline receiving fitting 92, to engage a cooperating fitting in a motor, and a compression spring 93 which urges the stem and cutter 10 from engagement with the motor and actuator).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Dubois et al. with a cutting window opening extending through the member sidewall of the cutting member, as taught by Daniel et al. with a cutting window opening to provide a path for material to pass from the surgical site through the shaft window and cutting member cutting window opening, or an axial adjustment coupling longitudinally securing the shaft relative to the cutting member, and with a resilient spring member, as a known substitution in the art for providing a coupling member having a spring for positioning the cutting member within the shaft distal end to maintain proper relative axial position during cutting and biasing the distal member end towards the distal shaft end and longitudinally compressing the spring to allow the distal member end to move in a proximal direction relative to the proximal shaft end, as taught by Daniel et al. to perform the act of maintaining the predetermined longitudinal distance between the distal member end and the distal shaft end while simultaneously articulating the shaft and the cutting member from the first configuration toward the second configuration, to accurately position the inner tip portion with the outer tip portion and aligning the outer member window with the cutting edge and distal tip which maintains the proper relative axial position therebetween during cutting, and to further provide an axial adjustment coupling including a spring and a spline, as taught by Kieturakis and known in the art, the axial adjustment coupling having a spline coupling that simultaneously allows for longitudinal translation of the proximal member end relative to a drive output gear for maintaining the predetermined longitudinal distance between components.
Regarding claim 23, Dubois et al. discloses engaging the tissue (paragraph 0090, device inserted into naval cavity and rotated to cut or engage tissue).
Regarding claim 24, Dubois et al. discloses severing the tissue from the nasal cavity (paragraph 0090, device inserted into naval cavity and rotated to cut tissue).
Regarding claim 25, Dubois et al. discloses applying suction to a lumen positioned within the cutting member to remove the tissue from the nasal cavity (paragraph 0090, the tissue may optionally be evacuated using suction created by the vacuum source).
Regarding claim 27, Dubois et al. discloses moving the cutting member with the cyclical movement comprising rotating the cutting member (paragraph 0006, cutter may be a rotating cutter).
Regarding claim 28, Dubois et al. discloses the shaft having a proximal shaft portion defining a longitudinal axis and a distal shaft portion extending distally from the proximal shaft portion (figure 1F), the first configuration of the distal shaft portion being aligned with the longitudinal axis (figure 1F, straight portion of shaft 12), and the second configuration the distal shaft portion being angularly positioned relative to the longitudinal axis (figure 1F, distal curved portion; paragraph 0067, malleable portion of the elongate shaft may be adjusted or manipulated before or during operation into various configurations ranging from straight to angled, or curved).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dubois et al. US 2015/0150580 in view of Daniel et al. US 5437630 and further in view of Altman et al. US 2018/0000499.
Regarding claim 26, Dubois et al. discloses a method of using a surgical instrument to treat a tissue within a nasal cavity of a patient (paragraph 0090, 0094), but fails to disclose tracking a location of the surgical instrument with a navigation system.
Altman et al. discloses a method of using a surgical instrument to treat a tissue within a nasal cavity of a patient (paragraph 0090, 0094), and tracking a location of the surgical instrument with a navigation system to indicate a position in relation to the subject’s anatomy or treatment area (paragraph 0047).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Dubois et al. with a navigation system, as taught by Altman et al. to indicate or track a position in relation to the subject’s anatomy or treatment area.
Claim(s) 29 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dubois et al. US 2015/0150580 in view of Daniel et al. US 5437630 and further in view of Stevens-Wright et al. US 5462527.
Regarding claim 29, Dubois et al. discloses the shaft having a proximal shaft portion defining a first configuration of the distal shaft portion being aligned with the longitudinal axis (figure 1F, straight portion of shaft 12), and the second configuration the distal shaft portion being angularly positioned relative to the longitudinal axis (figure 1F, distal curved portion; paragraph 0067, malleable portion of the elongate shaft may be adjusted or manipulated before or during operation into various configurations ranging from straight to angled, or curved), but fails to explicitly disclose the second configuration including a first articulated configuration and a second articulated configuration, the distal shaft portion being angularly positioned on a first side of the longitudinal axis in the first articulated configuration, the distal shaft portion being angularly positioned on a second side of the longitudinal axis that is opposite the first side of the longitudinal axis in the second articulated configuration.
Stevens-Wright et al. teaches a handle and elongate shaft 10 (figures 1, 13d) the second configuration including a first articulated configuration (for example, figure 13a) and a second articulated configuration (for example, figure 13c), the distal shaft portion being angularly positioned on a first side of the longitudinal axis in the first articulated configuration (figure 13a), the distal shaft portion being angularly positioned on a second side of the longitudinal axis that is opposite the first side of the longitudinal axis in the second articulated configuration (figure 13c) to control bending of the distal end for different applications (column 4, lines 43-67, left-right proximal bending and/or up-down distal ending of the distal end are possible to control movement).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Dubois et al. the second configuration including a first articulated configuration and a second articulated configuration, the distal shaft portion being angularly positioned on a first side of the longitudinal axis in the first articulated configuration, the distal shaft portion being angularly positioned on a second side of the longitudinal axis that is opposite the first side of the longitudinal axis in the second articulated configuration, as taught by Stevens-Wright et al. to provide a shaft having possible left-right proximal bending and/or up-down distal ending of the distal end to control movement of the distal end of the shaft for different applications and provide enhanced steerability.
Regarding claim 34, Dubois et al. discloses a surgical instrument essentially as claimed as discussed above, but fails to explicitly disclose transmitting force in tension and compression with a pair of push-pull cables to perform the act of articulating the shaft and the cutting member from the first configuration towards the second configuration.
Stevens-Wright et al. teaches a method of using a surgical instrument comprising a handle and an articulating elongate shaft 10 having a first and second configuration (figures 1, 13a-c) to control bending of the distal end for different applications (column 4, lines 43-67, left-right proximal bending and/or up-down distal ending of the distal end are possible to control movement), transmitting force in tension and compression with a pair of push-pull cables to perform the act of articulating the shaft and the cutting member from the first configuration towards the second configuration (column 2, line 58-column 3, line 6, column 4, lines 14-27; column 6, lines 25-6).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Dubois et al. to have a second configuration including a first articulated configuration and a second articulated configuration, transmitting force in tension and compression with a pair of push-pull cables to perform the act of articulating the shaft and the cutting member from the first configuration towards the second configuration, as taught by Stevens-Wright et al. to provide a known technique to a known device to obtain predictable results shaft resulting in possible left-right proximal bending and/or up-down distal ending of the distal end to control movement by tension of the distal end of the shaft for different applications and provide enhanced steerability.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dubois et al. US 2015/0150580 in view of Daniel et al. US 5437630 and further in view of Trott US 4646738.
Regarding claim 38, Dubois et al. in combination discloses a method of using a surgical instrument to treat a tissue within a nasal cavity of a patient, comprising maintaining an alignment of the cutting window opening with the shaft window opening simultaneously while performing the act of articulating the shaft and the cutting member from the straight configuration towards the articulated configuration (column 5, lines 58-61; to accurately position the inner tip portion with the outer tip portion and aligning the outer member window with the cutting edge and distal tip which maintains the proper relative axial position therebetween during cutting), but fails to explicitly disclose the act of maintaining the predetermined distance between the distal member end and the distal shaft end including non-contact of the distal member end with a proximal surface of the distal shaft end.
Trott teaches a surgical instrument (figure 3) comprising a shaft 12 configured to articulate from a straight configuration toward an articulated configuration (column 6, lines 42-50, outer tube is selectively bent for placement adjacent a surgical site by transmission means 22), including: (i) a distal shaft end 16, (ii) a proximal shaft end 14, (iii) a shaft sidewall extending from the distal shaft end to the proximal shaft end (sidewall of shaft 12) and configured to move the distal shaft end relative to the proximal shaft end (shaft bends at point 24, figure 3 between the distal and proximal ends), and (iv) a shaft window 18 opening extending through the shaft sidewall (figure 6); a cutting member 20 disposed within the shaft (figure 5) and configured to cyclically move relative to the shaft (column 7, lines 12-20, cutting member rotates for shearing tissue), wherein the cutting member is further configured to articulate within the shaft from the straight configuration toward the articulated configuration (by transmission means 22 to bend at segment 24 to bend the outer shaft 12, shown in the bent configuration figure 3), including: (i) a distal member end 42, (ii) a proximal member end 44, (iii) a member sidewall 45 extending from the distal member end to the proximal member end and configured to move the distal member end relative to the proximal member end (with transmission means 22 therebetween, column 7, lines 1-7), and (iv) a cutting window opening 48 extending through the member sidewall and configured to align with the shaft window during cyclical movement relative thereto and receive a tissue for cutting (figures 5, 6), the act of maintaining the predetermined distance between the distal member end and the distal shaft end including non-contact of the distal member end with a proximal surface of the distal shaft end (the distal end member and the distal shaft in both the straight and articulated configuration being spaced apart from one another or maintaining a gap or allowing non-contact defined by a predetermined distance at the distal end while still aligning the outer window and cutter window for cutting tissue, figure 5 and 6).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Dubois et al. with the act of maintaining the predetermined distance between the distal member end and the distal shaft end including non-contact of the distal member end with a proximal surface of the distal shaft end, as taught by Trott, as known in the art choosing from a finite number of identified, predictable solutions, with a reasonable expectations of success, such as a cutting member comprising a window and an outer shaft having a window, the cutting and outer windows being aligned for cutting tissue and allowing a pathway therethrough, while the distal ends have either contact or have non-contact defined by a predetermined distance at the distal end while aligning the outer window and cutter window.
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.
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/C.C.L/Examiner, Art Unit 3771
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771