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 11/28/2025 has been entered. Claims 1-20 remain pending the application.
Response to Arguments
Applicant's arguments filed on 11/28/2025 have been fully considered but they are not persuasive or are moot.
Applicant argue son pages 5-7 that Govari, Rubin, and Ciulla do not disclose the newly added limitations to the claims related to a coil sensor to indicate a roll orientation of the cutting window opening relative to the longitudinal axis. This argument is moot in view of the new grounds of rejection necessitated by amendment which relies on newly cited portions of Govari and Cheng to disclose these limitations in the claim. Accordingly, this argument is moot.
Applicant argues on pages 7 that Chang discloses using an accelerometer to detect rotation orientation, not a coil. However, the Examiner does not rely on Chang to disclose a position sensor coil. Accordingly, this argument is not persuasive.
Applicant argues on page 8 that Chang does not disclose positioning the sensor on a distal end of the device. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Here, the Examiner relies on Govari to disclose at least one position sensor on a distal end of the device. Accordingly, this argument is not persuasive.
Applicant argues on page 8 that Chang teaches away from placing the sensor on a distal end of the device. The Examiner respectfully disagrees. Chang does not criticize, discredit, or otherwise discourage positioning the sensor on a distal end of the device. If the reference does not teach that a combination is undesirable, then it cannot be said to teach away. Accordingly, this argument is not persuasive.
Applicant argues on page 8 that Cheng does not disclose positioning the sensor on a distal end of the device. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Here, the Examiner relies on Govari to disclose at least one position sensor on a distal end of the device. Accordingly, this argument is not persuasive.
Applicant argues on page 10 that modifying Govari with Cheng would change the principle operation of Govari because Govari uses optical sensor to track rotation and Cheng uses magnetic sensors. In response to applicant's argument that magnetic sensors and optical sensors are not compatible, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here, a person having ordinary skill in the art would understand that the magnetic sensors would be a suitable substitute for the optical sensors of Govari because they too can detect relative rotation between the inner and outer shaft, for example, by using the hall effect. Accordingly, this argument is not persuasive.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 10, 12-16, and 18-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12042163 in view of Govari et al. (US20170189123, hereafter Govari).
18777168
US12042163
1. A shaft assembly that extends along a longitudinal axis, the shaft assembly comprising:
5. An apparatus comprising:
(a) an elongate shaft defining a longitudinal axis, the elongate shaft including:
an outer shaft comprising a central lumen and a shaft window opening;
(i) a distal end,
(ii) an opening, and
(iii) a lumen configured to provide suction to the opening; and
a cutting member positioned within the central lumen of the outer shaft and configured to rotate about the longitudinal axis relative to the outer shaft, the cutting member comprising an inner lumen and a cutting window opening; and
a cutting element disposed in the lumen, the cutting element being configured to sever tissue protruding through the opening of the elongate shaft
the cutting element being configured to rotate within the lumen to thereby sever the tissue protruding through the opening of the elongate shaft.
at least one position sensor comprising a coil
the first position sensor comprising a first wire coil wrapped about a first coil axis, the second position sensor comprising a second wire coil wrapped about a second coil axis, the first coil axis being parallel with the longitudinal axis, the second coil axis being perpendicular to the first coil axis
positioned on a distal end of the outer shaft
N/A
being offset from the longitudinal axis of the outer shaft, the at least one position sensor being configured to indicate a roll orientation of the cutting window opening relative to the longitudinal axis.
(b) a first position sensor, the first position sensor being laterally offset from the longitudinal axis, the first position sensor being fixedly secured to the elongate shaft at a first known distance from the opening, the first position sensor being configured to generate signals indicating a position of the elongate shaft in three-dimensional space;
2. The shaft assembly of claim 1, wherein the central lumen is configured to receive tissue radially through the shaft window opening.
a cutting element disposed in the lumen, the cutting element being configured to sever tissue protruding through the opening of the elongate shaft
3. The shaft assembly of claim 1, wherein the inner lumen is configured to receive tissue radially through the cutting window opening.
a cutting element disposed in the lumen, the cutting element being configured to sever tissue protruding through the opening of the elongate shaft
10. The shaft assembly of claim 1, wherein the shaft window opening is in fluid communication with an environment surrounding the shaft assembly.
a cutting element disposed in the lumen, the cutting element being configured to sever tissue protruding through the opening of the elongate shaft
(iii) a lumen configured to provide suction to the opening; and
12. The shaft assembly of claim 1, wherein the at least one position sensor comprises two position sensors that are laterally offset from each other.
the first, second, and third position sensors being arranged along a helix extending about the longitudinal axis and,
13. The shaft assembly of claim 1, wherein each position sensor of the at least one position sensor generates signals to indicate a position of the shaft window opening and/or the cutting window opening.
(b) a first position sensor, the first position sensor being laterally offset from the longitudinal axis, the first position sensor being fixedly secured to the elongate shaft at a first known distance from the opening, the first position sensor being configured to generate signals indicating a position of the elongate shaft in three-dimensional space;
(c) a second position sensor, the second position sensor being laterally offset from the longitudinal axis and longitudinally offset from the first position sensor, the second position sensor being fixedly secured relative to the elongate shaft at a second known distance from the opening, the second position sensor being configured to generate signals indicating the position of the elongate shaft in three-dimensional space; and
(d) a third position sensor, the third position sensor being laterally offset from the longitudinal axis, the third position sensor being fixedly secured relative to the elongate shaft at a third known distance from the opening, the third position sensor being configured to generate signals indicating the position of the elongate shaft in three-dimensional space;
14. A shaft assembly that extends along a longitudinal axis,
5. An apparatus comprising:
(a) an elongate shaft defining a longitudinal axis, the elongate shaft including:
the shaft assembly comprising a cutting member with an inner lumen and a cutting window opening, wherein the cutting member is configured to rotate about the longitudinal axis and sever tissue at the cutting window opening.
(i) a distal end,
(ii) an opening, and
(iii) a lumen configured to provide suction to the opening; and
a cutting element disposed in the lumen, the cutting element being configured to sever tissue protruding through the opening of the elongate shaft.
a suction port fluidly connected to the inner lumen and operatively connected to a vacuum source,
(iii) a lumen configured to provide suction to the opening; and
at least one position sensor comprising a coil
the first position sensor comprising a first wire coil wrapped about a first coil axis, the second position sensor comprising a second wire coil wrapped about a second coil axis, the first coil axis being parallel with the longitudinal axis, the second coil axis being perpendicular to the first coil axis
positioned on a distal end of the outer shaft
N/A
being offset from the longitudinal axis of the outer shaft, the at least one position sensor being configured to indicate a roll orientation of the cutting window opening relative to the longitudinal axis.
(b) a first position sensor, the first position sensor being laterally offset from the longitudinal axis, the first position sensor being fixedly secured to the elongate shaft at a first known distance from the opening, the first position sensor being configured to generate signals indicating a position of the elongate shaft in three-dimensional space;
15. The shaft assembly of claim 14, wherein the cutting window opening further comprises a cutting edge configured to sever tissue.
a cutting element disposed in the lumen, the cutting element being configured to sever tissue protruding through the opening of the elongate shaft
16. The shaft assembly of claim 14, wherein the suction port is fluidly connected to the cutting window opening through the inner lumen.
(iii) a lumen configured to provide suction to the opening;
18. The shaft assembly of claim 14, wherein the suction port is configured to receive severed tissue and remove the severed tissue from the cutting window opening.
(iii) a lumen configured to provide suction to the opening;
19. The shaft assembly of claim 14, wherein the at least one position sensor comprises two position sensors that are laterally offset from each other.
the first, second, and third position sensors being arranged along a helix extending about the longitudinal axis and,
20. The shaft assembly of claim 14, wherein each position sensor of the at least one position sensor generates signals to indicate a position of the cutting window opening.
(b) a first position sensor, the first position sensor being laterally offset from the longitudinal axis, the first position sensor being fixedly secured to the elongate shaft at a first known distance from the opening, the first position sensor being configured to generate signals indicating a position of the elongate shaft in three-dimensional space;
(c) a second position sensor, the second position sensor being laterally offset from the longitudinal axis and longitudinally offset from the first position sensor, the second position sensor being fixedly secured relative to the elongate shaft at a second known distance from the opening, the second position sensor being configured to generate signals indicating the position of the elongate shaft in three-dimensional space; and
(d) a third position sensor, the third position sensor being laterally offset from the longitudinal axis, the third position sensor being fixedly secured relative to the elongate shaft at a third known distance from the opening, the third position sensor being configured to generate signals indicating the position of the elongate shaft in three-dimensional space;
The claims of US12042163 do not require the position sensor being positioned on a distal end of the outer shaft.
In analogous inserted surgical rotational cutter device field of endeavor Govari discloses require a position sensor being positioned on a distal end of the outer shaft (Govari, Para 34; “In other embodiments, the optical devices may be located at any suitable location of the distal end that enables the devices to detect optical reflections from optical marker 50.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify 18777168 in order to more accurately measure the rotation of the distal end of the device as taught by Govari (Govari, Para 34).
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.
Claims 1-7, 9-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (US20170189123, hereafter Govari) and Cheng et al. (US20190015127, hereafter Cheng).
Regarding claim 1, Govari discloses in Figures 1-2B a shaft assembly (system 20) that extends along a longitudinal axis (Figures 1-2B showing this), the shaft assembly comprising:
an outer shaft (hollow insertion tube 58) comprising a central lumen and a shaft window opening (opening 44); a cutting member (cutter 46 and shaft 56) positioned within the central lumen of the outer shaft and configured to rotate about the longitudinal axis relative to the outer shaft, the cutting member comprising an inner lumen and a cutting window opening (gap in front of cutter 46) (Govari, Para 21-23; " a rigid hollow insertion tube 58 for insertion into the nose of patient 22. Tube 58 is coaxially disposed around a rotating shaft 56 (shown in FIGS. 2A and 2B). Shaft 56 may be driven using any suitable mechanism, such as a direct current (DC) motor that can rotate clockwise and counterclockwise depending on the polarity of the electrical current applied to the motor. In some embodiments, tube 58 has an opening 44. Shaft 56 comprises a sinuplasty cutter 46 that is aligned with opening 44 in the insertion tube. Cutter 46 rotates with the shaft and is configured to cut polyp 45. Referring to inset 40, during the sinuplasty procedure, physician 24 navigates catheter 28 so that opening 44 is facing polyp 45. In an embodiment, cutter 46 does not block opening 46 so that polyp 45 may be inserted through opening 44 into tube 58. In other embodiments, physician 24 may confirm the position of opening 46 with respect to polyp 45 using mapping techniques such as depicted in U.S. patent application Ser. No. 14/942,455, to Govari et al., filed Nov. 16, 2015, which is incorporated herein by reference.") (Govari, Para 24; "Once polyp 45 passes through opening 44, physician 24 may use console 33 or proximal end 30 to rotate shaft 56 including cutter 46 so as to remove at least part of polyp 45. In some embodiments, after removing the polyp, physician 24 may rotate shaft 56 to any desired angular position relative to opening 44. For example, as shown in inset 43, physician 24 may rotate shaft 56 so that cutter 46 is facing the right side of tube 58 and the body of shaft 56 blocks opening 44. Catheter 28 draws the removed polyp into a drain (not shown) located, for example, in proximal end 30.");
a position sensor positioned on a distal end of the outer shaft and being offset from the longitudinal axis of the outer shaft (Govari, Para 34; “In other embodiments, the optical devices may be located at any suitable location of the distal end that enables the devices to detect optical reflections from optical marker 50.”);
the opening positioned on a distal end of the outer shaft (Govari, Para 16; “The distal end of the catheter may comprise various kinds of surgical tools, such as a rotatable cutter disposed in an insertion tube having an opening.”).
Govari does not clearly and explicitly disclose wherein the at least one position sensor comprises a coil, the at least one position sensor being configured to indicate a roll orientation of the cutting window opening relative to the longitudinal axis.
In an analogous inserted cutting surgical device field of endeavor Cheng discloses at least one position sensor comprising a coil (Cheng, Para 31; “The one or more sensing devices may comprise any suitable number and any suitable types of sensors, magnets, or both. For example, the one or more sensors may comprise or include any number of electromagnetic sensors, electromagnetic coils”) the at least one position sensor being configured to indicate a roll orientation of the cutting window opening relative to the longitudinal axis (Cheng, Para 7; “The medical instrument includes a sensing device. In response to a magnetic field, the sensing device can provide an output signal indicative of the position of the sensor. The position of the outer blade, the outer blade cutting window, or both relative to the sensor is known or can be calculated and/or determined from the output signals. […] The virtual representation can include a rotational orientation of the outer blade cutting window so that its position relative to the anatomy or a surgical site can be determined”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Govari wherein the at least one position sensor comprises a coil, the at least one position sensor being configured to indicate a roll orientation of the cutting window opening relative to the longitudinal axis in order to allow a user to more accurately know the relative position of the surgery site relative to the cutting window as taught by Cheng (Cheng, Para 5-8).
Regarding claim 2, Govari as modified by Cheng above discloses all of the limitations of claim 1 as discussed above.
Govari further discloses wherein the central lumen is configured to receive tissue radially through the shaft window opening (Govari, Para 23; “polyp 45 may be inserted through opening 44 into tube 58. In other embodiments, physician 24 may confirm the position of opening 46 with respect to polyp 45 using mapping techniques such as depicted in U.S. patent application Ser. No. 14/942,455, to Govari et al., filed Nov. 16, 2015, which is incorporated herein by reference”) (Govari, Para 24; “Once polyp 45 passes through opening 44, physician 24 may use console 33 or proximal end 30 to rotate shaft 56 including cutter 46 so as to remove at least part of polyp 45. In some embodiments, after removing the polyp, physician 24 may rotate shaft 56 to any desired angular position relative to opening 44. For example, as shown in inset 43, physician 24 may rotate shaft 56 so that cutter 46 is facing the right side of tube 58 and the body of shaft 56 blocks opening 44. Catheter 28 draws the removed polyp into a drain (not shown) located, for example, in proximal end 30”) (Govari, Figures 1-2B).
Regarding claim 3, Govari as modified by Cheng above discloses all of the limitations of claim 1 as discussed above.
Govari further discloses wherein the inner lumen is configured to receive tissue radially through the cutting window opening (Govari, Para 23; “polyp 45 may be inserted through opening 44 into tube 58. In other embodiments, physician 24 may confirm the position of opening 46 with respect to polyp 45 using mapping techniques such as depicted in U.S. patent application Ser. No. 14/942,455, to Govari et al., filed Nov. 16, 2015, which is incorporated herein by reference”) (Govari, Para 24; “Once polyp 45 passes through opening 44, physician 24 may use console 33 or proximal end 30 to rotate shaft 56 including cutter 46 so as to remove at least part of polyp 45. In some embodiments, after removing the polyp, physician 24 may rotate shaft 56 to any desired angular position relative to opening 44. For example, as shown in inset 43, physician 24 may rotate shaft 56 so that cutter 46 is facing the right side of tube 58 and the body of shaft 56 blocks opening 44. Catheter 28 draws the removed polyp into a drain (not shown) located, for example, in proximal end 30”) (Govari, Figures 1-2B).
Regarding claim 4, Govari as modified by Cheng above discloses all of the limitations of claim 1 as discussed above.
Govari further discloses wherein the cutting window opening rotates through a position in which the cutting window opening longitudinally aligns with the shaft window opening (Govari, Para 22; “In some embodiments, tube 58 has an opening 44. Shaft 56 comprises a sinuplasty cutter 46 that is aligned with opening 44 in the insertion tube. Cutter 46 rotates with the shaft and is configured to cut polyp 45.”) (Govari, Figures 1-2B).
Regarding claim 5, Govari as modified by Cheng above discloses all of the limitations of claim 1 as discussed above.
Govari further discloses wherein the shaft window opening (edge opposite cutter 46) further comprises an opposing edge (Govari, Para 24; “Once polyp 45 passes through opening 44, physician 24 may use console 33 or proximal end 30 to rotate shaft 56 including cutter 46 so as to remove at least part of polyp 45.”) (Govari, Figures 1-2B).
Regarding claim 6, Govari as modified by Cheng above discloses all of the limitations of claim 5 as discussed above.
Govari further discloses wherein the cutting window opening further comprises a cutting edge (cutter 46) (Govari, Para 24; “Once polyp 45 passes through opening 44, physician 24 may use console 33 or proximal end 30 to rotate shaft 56 including cutter 46 so as to remove at least part of polyp 45.”) (Govari, Figures 1-2B).
Regarding claim 7, Govari as modified by Cheng above discloses all of the limitations of claim 6 as discussed above.
Govari further discloses wherein the cutting edge slides against the opposing edge to sever tissue received at the shaft window opening and the cutting window opening (Govari, Para 22; “In some embodiments, tube 58 has an opening 44. Shaft 56 comprises a sinuplasty cutter 46 that is aligned with opening 44 in the insertion tube. Cutter 46 rotates with the shaft and is configured to cut polyp 45.”) (Govari, Para 24; “Once polyp 45 passes through opening 44, physician 24 may use console 33 or proximal end 30 to rotate shaft 56 including cutter 46 so as to remove at least part of polyp 45.”) (Govari, Figures 1-2B).
Regarding claim 9, Govari as modified by Cheng above discloses all of the limitations of claim 1 as discussed above.
Govari further discloses wherein the shaft assembly is flexible (Govari, Para 16; “During the procedure, the physician navigates the distal end of a surgical catheter to the location of the polyp.”) (Govari, Figure 1).
A person having ordinary skill in the art would understand that to navigate the device of Govari to the polyps in the sinus it would have to bend to access them.
Regarding claim 10, Govari as modified by Cheng above discloses all of the limitations of claim 1 as discussed above.
Govari further discloses wherein the shaft window opening is in fluid communication with an environment surrounding the shaft assembly (Govari, Para 23-24; “Referring to inset 40, during the sinuplasty procedure, physician 24 navigates catheter 28 so that opening 44 is facing polyp 45. In an embodiment, cutter 46 does not block opening 46 so that polyp 45 may be inserted through opening 44 into tube 58. […] Once polyp 45 passes through opening 44,”).
Regarding claim 11, Govari as modified by Cheng above discloses all of the limitations of claim 1 as discussed above.
Govari further discloses wherein the inner lumen is in fluid communication with an environment surrounding the shaft assembly when the cutting window opening longitudinally aligns with the shaft window opening (Govari, Para 22; “In some embodiments, tube 58 has an opening 44. Shaft 56 comprises a sinuplasty cutter 46 that is aligned with opening 44 in the insertion tube. Cutter 46 rotates with the shaft and is configured to cut polyp 45.”) (Govari, Para 24; “Once polyp 45 passes through opening 44, physician 24 may use console 33 or proximal end 30 to rotate shaft 56 including cutter 46 so as to remove at least part of polyp 45.”) (Govari, Figures 1-2B).
Regarding claim 13, Govari as modified by Cheng above discloses all of the limitations of claim 1 as discussed above.
Govari further discloses tracking a position of the shaft window opening and/or the cutting window opening (Govari, Para 23; “physician 24 may confirm the position of opening 46 with respect to polyp 45 using mapping techniques such as depicted in U.S. patent application Ser. No. 14/942,455, to Govari et al., filed Nov. 16, 2015, which is incorporated herein by reference.”).
Govari does not clearly and explicitly disclose wherein each position sensor of the at least one position sensor generates signals to indicate a position of the shaft window opening and/or the cutting window opening.
Cheng further discloses wherein at least one position sensor generates signals to indicate a position of the shaft window opening and/or the cutting window opening (Cheng, Para 7; “The medical instrument includes a sensing device. In response to a magnetic field, the sensing device can provide an output signal indicative of the position of the sensor. The position of the outer blade, the outer blade cutting window, or both relative to the sensor is known or can be calculated and/or determined from the output signals. […] The virtual representation can include a rotational orientation of the outer blade cutting window so that its position relative to the anatomy or a surgical site can be determined”) (Cheng, Para 31; “The one or more sensing devices may comprise any suitable number and any suitable types of sensors, magnets, or both. For example, the one or more sensors may comprise or include any number of electromagnetic sensors, electromagnetic coils”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Govari wherein each position sensor of the at least one position sensor generates signals to indicate a position of the shaft window opening and/or the cutting window opening in order to allow a user to more accurately know the relative position of the surgery site relative to the cutting window as taught by Cheng (Cheng, Para 5-8).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Govari and Cheng as applied to claim 7 above and in further view of Rubin (US20140288560).
Regarding claim 8, Govari as modified by Cheng above discloses all of the limitations of claim 7 as discussed above.
Govari further discloses collecting tissue severed at the cutting edge when the cutting window opening longitudinally aligns with the shaft window opening (Govari, Para 24; “Catheter 28 draws the removed polyp into a drain (not shown) located, for example, in proximal end 30”).
Govari does not clearly and explicitly disclose using a vacuum source to do so.
In an analogous rotary cutting tool field of endeavor Rubin discloses a vacuum source in fluid communication with a lumen with an opening, wherein an elongate shaft is operable to apply suction from the vacuum source through an opening of the elongate shaft (Rubin, Para 22; “the aspiration port 142 is adapted for connection to tubing (not shown) that in turn is connected to a vacuum source (not shown) for applying a vacuum to the aspiration path, and thus (directly or indirectly) to the first tubular member 40. Similarly, the irrigation path is formed within the housing 130, extending from an irrigation port 144. The irrigation port 144, in turn, is adapted for fluid connection to tubing (not shown) that is otherwise connected to a fluid source (not shown). Thus, the handpiece 36 provides for internal irrigation”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Govari to include a vacuum source in fluid communication with the shaft window opening, wherein the vacuum source applies a suction through the inner lumen in order to allow for irrigation as needed as taught by Rubin (Rubin, Para 22).
Claims 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Govari and Cheng as applied to claim 1 above, and in further view of Chang et al. (US20060004286, hereafter Chang).
Regarding claim 9, Govari as modified by Cheng above is interpreted as disclosing the limitations of claim 9 as discussed above but for the sake of compact prosecution the follow rejection is offered as well.
In an analogous inserted surgical device field of endeavor Chang discloses wherein a shaft assembly is flexible (Chang, Para 20; “the shaft of the working device proximal to the sensor(s) may be flexible or malleable. Such flexibility or malleability may allow the working device to be advanced though tortuous regions of the intra nasal anatomy and/or to be positioned behind obstructive anatomical structure(s) (e.g., behind the uncinate process) without traumatizing or requiring removal or surgical modification of the obstructive anatomical structure(s)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Govari wherein the shaft assembly is flexible in order to allow the device to be advanced though tortuous regions of the intra nasal anatomy and to be positioned behind obstructive anatomical structures without traumatizing or requiring removal or surgical modification of the obstructive anatomical structures as taught by Chang (Chang, Para 20).
Regarding claim 12, Govari as modified by Cheng above discloses all of the limitations of claim 1 as discussed above.
Govari does not clearly and explicitly disclose wherein the at least one position sensor comprises two position sensors that are laterally offset from each other.
In an analogous inserted surgical device field of endeavor Chang discloses two position sensors that are laterally offset from each other (Figure 4C-4F showing position sensors 16 longitudinally offset from one another) (Chang, Para 81; “The sensors 16 are mounted on the outer tube 100 at spaced apart locations”) (Chang, Para 82; “the proximal sensor 16 is positioned on the outer tube 100 a at a location that is directly beneath the proximal end of the straight walled midportion MP of the balloon 46 and the other sensor 16 is positioned on the inner tube 102 a at a location that is directly beneath the distal end of the straight walled midportion MP of the balloon 46”) (Chang, Para 86; “It is to be appreciated that the specific examples shown in the drawings are merely examples. Indeed, the sensors 16 may be positioned at many other locations other than those shown in these examples”) (Chang, Para 101; “the guidewire is advanced as the sensor(s) 16 on the guidewire 10 receive signals from the transmitter site(s) 76 and in turn the sensor(s) 16 send signals to the computer 78.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Govari wherein each position sensor of the at least one position sensor is longitudinally offset from other position sensors as taught by Chang in order to allow a user to track multiple positions of the device and therefore navigate with greater accuracy.
Claims 14-16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Govari, Cheng, and Rubin (US20140288560).
Regarding claim 14, Govari discloses in Figures 1-2B a shaft assembly (system 20) that extends along a longitudinal axis (Figures 1-2B showing this), the shaft assembly comprising:
a cutting member (cutter 46 and shaft 56) comprising an inner lumen and a cutting window opening (gap in front of cutter 46); wherein the cutting member is configured to rotate about the longitudinal axis and sever tissue at the cutting window opening (Govari, Para 21-23; " a rigid hollow insertion tube 58 for insertion into the nose of patient 22. Tube 58 is coaxially disposed around a rotating shaft 56 (shown in FIGS. 2A and 2B). Shaft 56 may be driven using any suitable mechanism, such as a direct current (DC) motor that can rotate clockwise and counterclockwise depending on the polarity of the electrical current applied to the motor. In some embodiments, tube 58 has an opening 44. Shaft 56 comprises a sinuplasty cutter 46 that is aligned with opening 44 in the insertion tube. Cutter 46 rotates with the shaft and is configured to cut polyp 45. Referring to inset 40, during the sinuplasty procedure, physician 24 navigates catheter 28 so that opening 44 is facing polyp 45. In an embodiment, cutter 46 does not block opening 46 so that polyp 45 may be inserted through opening 44 into tube 58. In other embodiments, physician 24 may confirm the position of opening 46 with respect to polyp 45 using mapping techniques such as depicted in U.S. patent application Ser. No. 14/942,455, to Govari et al., filed Nov. 16, 2015, which is incorporated herein by reference.") (Govari, Para 24; "Once polyp 45 passes through opening 44, physician 24 may use console 33 or proximal end 30 to rotate shaft 56 including cutter 46 so as to remove at least part of polyp 45. In some embodiments, after removing the polyp, physician 24 may rotate shaft 56 to any desired angular position relative to opening 44. For example, as shown in inset 43, physician 24 may rotate shaft 56 so that cutter 46 is facing the right side of tube 58 and the body of shaft 56 blocks opening 44. Catheter 28 draws the removed polyp into a drain (not shown) located, for example, in proximal end 30.");
a position sensor positioned on a distal end of the outer shaft and being offset from the longitudinal axis of the outer shaft (Govari, Para 34; “In other embodiments, the optical devices may be located at any suitable location of the distal end that enables the devices to detect optical reflections from optical marker 50.”);
the opening positioned on a distal end of the outer shaft (Govari, Para 16; “The distal end of the catheter may comprise various kinds of surgical tools, such as a rotatable cutter disposed in an insertion tube having an opening.”); and
collecting tissue severed in the lumen (Govari, Para 24; “Catheter 28 draws the removed polyp into a drain (not shown) located, for example, in proximal end 30”).
Govari does not clearly and explicitly disclose wherein the at least one position sensor comprises a coil, the at least one position sensor being configured to indicate a roll orientation of the cutting window opening relative to the longitudinal axis, and a suction port fluidly connected to the inner lumen and operatively connected to a vacuum source.
In an analogous inserted cutting surgical device field of endeavor Cheng discloses at least one position sensor comprising a coil (Cheng, Para 31; “The one or more sensing devices may comprise any suitable number and any suitable types of sensors, magnets, or both. For example, the one or more sensors may comprise or include any number of electromagnetic sensors, electromagnetic coils”) the at least one position sensor being configured to indicate a roll orientation of the cutting window opening relative to the longitudinal axis (Cheng, Para 7; “The medical instrument includes a sensing device. In response to a magnetic field, the sensing device can provide an output signal indicative of the position of the sensor. The position of the outer blade, the outer blade cutting window, or both relative to the sensor is known or can be calculated and/or determined from the output signals. […] The virtual representation can include a rotational orientation of the outer blade cutting window so that its position relative to the anatomy or a surgical site can be determined”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Govari wherein the at least one position sensor comprises a coil, the at least one position sensor being configured to indicate a roll orientation of the cutting window opening relative to the longitudinal axis in order to allow a user to more accurately know the relative position of the surgery site relative to the cutting window as taught by Cheng (Cheng, Para 5-8).
In an analogous rotary cutting tool field of endeavor Rubin discloses a vacuum source in fluid communication with a lumen (Rubin, Para 22; “the aspiration port 142 is adapted for connection to tubing (not shown) that in turn is connected to a vacuum source (not shown) for applying a vacuum to the aspiration path, and thus (directly or indirectly) to the first tubular member 40. Similarly, the irrigation path is formed within the housing 130, extending from an irrigation port 144. The irrigation port 144, in turn, is adapted for fluid connection to tubing (not shown) that is otherwise connected to a fluid source (not shown). Thus, the handpiece 36 provides for internal irrigation”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Govari to include a suction port fluidly connected to the inner lumen and operatively connected to a vacuum source in order to allow for irrigation as needed as taught by Rubin (Rubin, Para 22).
Regarding claim 15, Govari as modified by Cheng and Rubin above discloses all of the limitations of claim 14 as discussed above.
Govari further discloses wherein the cutting window opening further comprises a cutting edge configured to sever tissue (cutter 46) (Govari, Para 24; “Once polyp 45 passes through opening 44, physician 24 may use console 33 or proximal end 30 to rotate shaft 56 including cutter 46 so as to remove at least part of polyp 45.”) (Govari, Figures 1-2B).
Regarding claim 16, Govari as modified by Cheng and Rubin above discloses all of the limitations of claim 14 as discussed above.
Govari as modified by Rubin above further discloses wherein the suction port is fluidly connected to the cutting window opening through the inner lumen (Govari, Para 24; “Catheter 28 draws the removed polyp into a drain (not shown) located, for example, in proximal end 30”).
Regarding claim 18, Govari as modified by Cheng and Rubin above discloses all of the limitations of claim 14 as discussed above.
Govari as modified by Rubin above further discloses wherein the suction port is configured to receive severed tissue and remove the severed tissue from the cutting window opening (Govari, Para 24; “Catheter 28 draws the removed polyp into a drain (not shown) located, for example, in proximal end 30”).
Regarding claim 20, Govari as modified by Cheng and Rubin above discloses all of the limitations of claim 14 as discussed above.
Govari further discloses tracking a position of the shaft window opening and/or the cutting window opening (Govari, Para 23; “physician 24 may confirm the position of opening 46 with respect to polyp 45 using mapping techniques such as depicted in U.S. patent application Ser. No. 14/942,455, to Govari et al., filed Nov. 16, 2015, which is incorporated herein by reference.”).
Govari does not clearly and explicitly disclose wherein each position sensor of the at least one position sensor generates signals to indicate a position of the shaft window opening and/or the cutting window opening.
Cheng further discloses wherein at least one position sensor generates signals to indicate a position of the shaft window opening and/or the cutting window opening (Cheng, Para 7; “The medical instrument includes a sensing device. In response to a magnetic field, the sensing device can provide an output signal indicative of the position of the sensor. The position of the outer blade, the outer blade cutting window, or both relative to the sensor is known or can be calculated and/or determined from the output signals. […] The virtual representation can include a rotational orientation of the outer blade cutting window so that its position relative to the anatomy or a surgical site can be determined”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Govari wherein each position sensor of the at least one position sensor generates signals to indicate a position of the shaft window opening and/or the cutting window opening in order to allow a user to more accurately know the relative position of the surgery site relative to the cutting window as taught by Cheng (Cheng, Para 5-8).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Govari, Cheng, and Rubin as applied to claim 14 above, and in further view of Ciulla et al. (US20150190163, hereafter Ciulla).
Regarding claim 17, Govari as modified by Cheng and Rubin above discloses all of the limitations of claim 14 as discussed above.
Govari as modified by Rubin arguably discloses wherein the suction port is configured to draw tissue towards the cutting window opening because Govari as modified by Cheng and Rubin above is physically capable of using it’s suction to draw tissue towards the cutting window opening because its vacuum source is connected to the cutting window, however for the sake of compact prosecution the following rejection is presented.
In an analogous inserted cutting surgical device field of endeavor Ciulla discloses wherein the suction port is configured to draw tissue towards the cutting window opening (Ciulla, Para 31; “The sidewall may further define an opening 35 (e.g., window and/or passageway) configured to receive the target tissue. The lumen may be operably and selectively coupled to a suction source (e.g., vacuum pump not shown) via connection 80 to provide suction through the opening 35 to draw the tissue into the opening 35 and/or to remove tissue from the patient's body. Additionally, the outer member 30 may have a closed distal end 90 that helps maintain suction via the opening 35, and thereby maintains target tissue (or a portion of the target tissue) within the opening 35.”) (Ciulla, Para 32; “the opening 35 may optionally include a sharp edge 60 to facilitate tissue severing, as discussed in greater detail below”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Govari wherein the suction port is configured to draw tissue towards the cutting window opening as taught by Ciulla in order to more easily facilitate tissue cutting.
Claims 19 is rejected under 35 U.S.C. 103 as being unpatentable over Govari, Cheng, and Rubin as applied to claim 14 above, and in further view of Chang et al. (US20060004286, hereafter Chang).
Regarding claim 19, Govari as modified by Cheng and Rubin above discloses all of the limitations of claim 14 as discussed above.
Govari does not clearly and explicitly disclose wherein each position sensor of the at least one position sensor is longitudinally offset from other position sensors.
In an analogous inserted surgical device field of endeavor Chang discloses wherein each position sensor of the at least one position sensor is longitudinally offset from other position sensors (Figure 4C-4F showing position sensors 16 longitudinally offset from one another) 9Chang, Para 81; “The sensors 16 are mounted on the outer tube 100 at spaced apart locations”) (Chang, Para 82; “the proximal sensor 16 is positioned on the outer tube 100 a at a location that is directly beneath the proximal end of the straight walled midportion MP of the balloon 46 and the other sensor 16 is positioned on the inner tube 102 a at a location that is directly beneath the distal end of the straight walled midportion MP of the balloon 46”) (Chang, Para 86; “It is to be appreciated that the specific examples shown in the drawings are merely examples. Indeed, the sensors 16 may be positioned at many other locations other than those shown in these examples”) (Chang, Para 101; “the guidewire is advanced as the sensor(s) 16 on the guidewire 10 receive signals from the transmitter site(s) 76 and in turn the sensor(s) 16 send signals to the computer 78.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Govari wherein each position sensor of the at least one position sensor is longitudinally offset from other position sensors as taught by Chang in order to allow a user to track multiple positions of the device and therefore navigate with greater accuracy.
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 peri