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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/2/2024 and 4/29/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 7, 9 and 12-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barnes (US 2019/0110851 A1)
Regarding claim 1, Barnes discloses:
A device for cutting body tissue (device 200, see Fig. 5), comprising:
a handle (see Fig. 5), comprising:
a first actuator (lever 216, see Fig. 5); and
a second actuator (blade actuator 222, see Fig. 5) in communication with the first actuator (see Para. [0070] mentioning wherein inflation of the balloon (via lever 216) unlocks the cutting blade for actuation via blade actuator 222);
a blade (blade 228, see Fig. 5) coupled with the second actuator (see Para. [0033]);
a shaft (shaft 220, see Fig. 5) extending distally from the handle (see Fig. 5), the shaft defining a guideway along which the blade is configured to travel (see Para. [0034]) ; and
an expander (balloons 234a/234b, see Fig. 5) in communication with the first actuator (see Para. [0044]) and extending along the shaft (see Fig. 5);
wherein actuation of the first actuator adjusts the expander to an expanded position (see Para. [0044]-[0045]) and unlocks the second actuator to allow actuation of the second actuator and longitudinal movement of the blade along the guideway (see Para. [0070]).
Regarding claim 2, Barnes discloses the invention of claim 1, Barnes further discloses wherein in response to forces applied to the first actuator, the first actuator is configured to adjust between an unactuated position in which the expander is in a relaxed position and a fully actuated position in which the expander is in the expanded position (see Para. [0045]-[0047], [0067] and [0070]).
Regarding claim 3, Barnes discloses the invention of claim 2, Barnes further discloses wherein the first actuator is biased toward the unactuated position and the first actuator is configured to remain in the fully actuated position after the first actuator is adjusted to the fully actuated position and the forces applied to the first actuator are removed (see Para. [0046]-[0047] mentioning a locking mechanism to lock lever 216 at a desired actuation state).
Regarding claim 4, Barnes discloses the invention of claim 1, Barnes further discloses an expansion system (inflation assembly 218, see Para. [0041]) at least partially located in the handle (see Fig. 5) and in communication with the first actuator and the expander (see Para. [0041]-[0045] and [0055]-[0056]), wherein the expansion system is configured to cause the expander to expand in response to actuation of the first actuator (see Para. [0041]-[0045] and [0055]-[0056]; inflation fluid flows through conduits 286a/286b and into the balloon to cause inflation and/or deflation).
Regarding claim 5, Barnes discloses the invention of claim 4, Barnes further discloses wherein the expansion system comprises a expansion device (inflation device 288, see Fig. 5 and Para. [0041]), a manifold (subsystems of inflation assembly 218 as mentioned in Para. [0041]-[0045] including fluid couplings 272, a fill port 273, ports 274/276 and first/second tubes 280/282) in communication with the expansion device (see Para. [0041]-[0045]), and tubing in communication with the manifold and the expander (inflation conduits 286a/286b, see Fig. 5 and Para. [0041]-[0045] and [0055]-[0056]), the expansion device being configured to cause fluid to flow through the manifold and the tubing to the expander in response to actuation of the first actuator (see Para. [0041]-[0045] and [0055]-[0056]).
Regarding claim 7, Barnes discloses the invention of claim 4, Barnes further discloses a linkage coupled with the first actuator and second actuator (see Para. [0070] mentioning wherein the blade actuation system is locked until actuation of lever 216, indicating a linkage between the two actuators).
Regarding claim 9, Barnes discloses the invention of claim 1, Barnes further discloses a linkage extending between the first actuator and the first actuator (see Para. [0070] mentioning wherein the blade actuation system is locked until actuation of lever 216, indicating a linkage between the two actuators), and wherein the linkage disengages from the second actuator when the first actuator is in a fully actuated position to unlock the second actuator and allow actuation of the second actuator to longitudinally move the blade along the guideway (see Para. [0070] mentioning wherein the blade actuation system is locked until actuation of lever 216 which causes the blade actuation system to become unlocked).
Regarding claim 12, Barnes discloses the invention of claim 1, Barnes further discloses wherein the second actuator is a second actuator and has a first extension and a second extension spaced proximally from the first extension (see Fig. 6 showing wherein blade activation assembly 222 has two raised, radial extensions on the terminal ends thereof).
Regarding claim 13, Barnes discloses:
A method of operating a device for cutting body tissue, the method comprising:
actuating a first actuator (lever 216, see Fig. 5) to radially enlarge an expander (balloon(s) 234a/234b; see Para. [0044]) extending along a guideway (shaft 220, see Fig. 5) for a blade (blade 228, see Fig. 5) of the device for cutting body tissue and unlock a second actuator (blade actuator 222, see Fig. 5) coupled with the blade (see Para. [0033] and [0070]); and
adjusting the second actuator to move the blade from a protected first position to a cutting second position (see Para. [0033], [0038], [0040] and [0047]).
Regarding claim 14, Barnes discloses the method of claim 13, Barnes further discloses wherein the expander is a balloon (balloons 234a/234b, see Fig. 5), and the method further comprises: priming an expansion system (inflation assembly 218, see Para. [0041]) with fluid (see Para. [0041]-[0045]), and wherein actuating the first actuator actuates an expansion device of the expansion system causing the fluid to travel to the balloon and radially enlarge the balloon (see Para. [0041]-[0045] and [0055]-[0056]).
Regarding claim 15, Barnes discloses the method of claim 14, Barnes further discloses wherein priming the expansion system with fluid comprises: engaging a fluid source (priming syringe, see Para. [0042]) with a priming port (fill port 273, see Para. [0041]-[0042] and Fig. 5) of the device for cutting body tissue; creating a vacuum pressure in the expansion system (see Para. [0045] and [0056]) and the fluid source by withdrawing a plunger (see Para. [0042] mentioning a plunger causing the pressurization of the inflation fluid) of the fluid source; and releasing the plunger (see Para. [0041]-[0045] and [0055]-[0056]).
Regarding claim 16, Barnes discloses the method of claim 13, Barnes further discloses adjusting the second actuator to move the blade from the cutting second position to a protected third position (see Para. [0040] and [0047]-[0048]]).
Regarding claim 17, Barnes teaches:
A handle assembly of a device for cutting body tissue (see Fig. 5), the handle assembly comprising:
a lever (lever 216, see Fig. 5);
an expansion system (balloons 234a/234b, see Fig. 5) in communication with the lever (see Para. [0044]);
a slider (blade actuator 222, see Fig. 5) configured to couple with a blade (blade 228, see Fig. 5 and Para. [0033]) and longitudinally adjust the blade as the slider is longitudinally adjusted (see Para. [0033], [0038], [0040] and [0047]); and
a linkage coupled with the lever and configured to limit movement of the slider (see Para. [0070] mentioning wherein the blade actuation system is locked until actuation of lever 216, indicating a linkage between the two actuators); and
wherein when the lever is adjusted to a fully actuated position, the linkage is configured unlock the slider and allow the slider to adjust longitudinally (see Para. [0067] and [0070]).
Regarding claim 18, Barnes discloses the invention of claim 17, Barnes further discloses a priming port (fill port 273, see Fig. 5) in fluid communication with the expansion system (see Para. [0041]-[0042]).
Regarding claim 19, Barnes discloses the invention of claim 18, Barnes further discloses wherein the expansion system comprises: a manifold (subsystems of inflation assembly 218 as mentioned in Para. [0041]-[0045] including fluid couplings 272, a fill port 273, ports 274/276 and first/second tubes 280/282) in communication with the priming port (see Para. [0041]-[0042]; tubing in fluid communication with the manifold (inflation conduits 286a/286b, see Fig. 5 and Para. [0041]-[0045] and [0055]-[0056]); and an expansion device (inflation device 288, see Fig. 5 and Para. [0041]) configured to move fluid through the manifold and the tubing in response to adjustments of the lever (see Para. [0041]-[0045] and [0055]-[0056]).
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnes (US 2019/0110851 A1) in view of Milsom (US 2020/0121168 A1).
Regarding claim 6, Barnes discloses the invention of claim 4, Barnes further discloses wherein the handle comprises a priming port (fill port 273, see Fig. 5) in fluid communication with the expansion system (see Para. [0041]-[0042]) and configured to engage a fluid source (see Para. [0041]-[0042]), the priming port including a valve configured to open in response to the priming port engaging with the fluid source (see Para. [0041]-[0042]).
However, Barnes does not expressly disclose wherein the valve is a one-way valve.
In the same field of endeavor, namely inflatable probe devices configured to cut tissue, Milson teaches wherein a one-way valve (i.e., a check valve) allows inflation media (i.e., air) to enter a system in one direction (i.e., inwardly) while prevent air from flowing through the system in an opposite direction (see Para. [0182]-[0185]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the fill port of Barnes to be in the form of a one-way valve as taught and suggested by Milsom to, in this case, allow inflation media to enter the device and flow to the balloons during use while prevent fluid flow out from the device (i.e., preventing leakage) (see Milsom Para. [0182]-[0185]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnes (US 2019/0110851 A1) in view of Malkowski (US 2011/0184459 A1).
Regarding claim 8, Barnes discloses all of the limitations of the invention of claim 7.
However, while Barnes further discloses wherein the first actuator can be locked in a desired position (see Para. [0046]-[0047]) Barnes does not expressly disclose wherein the mechanism for locking and locking the first actuator is an over-center mechanism.
In the same field of endeavor, namely surgical devices configured to cut tissue, Malkowski teaches a surgical device (see Fig. 1) comprising an actuator trigger (trigger 5304, see Fig. 69) configured to lock an articulatable portion of the device in a desired position via an over-center mechanism (see Para. [0241]-[0243]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known locking mechanism for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the mechanism for locking the lever (216) in a desired orientation be in the form of an over-center mechanism as disclosed by Malkowski. Since both the locking mechanism(s) of Barnes and Malkowski are configured to lock an articulation lever in a desired orientation, one of ordinary skill in the art would have expected the device of Barnes to function equally well with either the currently-disclosed locking pin assembly or an over-center mechanism as disclosed by Malkowski. Since no additional special features solving a disclosed problem are associated with the locking mechanism of Barnes, one of ordinary skill in the art would have been able to interchange the two known locking configurations without impacting or hindering the normal function of the device of Barnes.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnes (US 2019/0110851 A1) in view of Li (CN 115054323 A).
Regarding claim 10, Barnes discloses all of the limitations of the invention of claim 1.
However, Barnes does not provide a description of the shape of the shaft lumen housing the blade and thus does not expressly disclose wherein the guideway comprises a first portion with an incline, a second portion extending proximally from the first portion, and a third portion extending proximally from the second portion and having a decline.
In the same field of endeavor, namely devices for cutting body tissue, Li teaches:
A device for cutting body tissue (see Fig. 1), comprising:
a handle (casing 25, see Fig. 1), comprising:
a blade (cutting member 1111’, see Fig. 14 showing the chosen blade embodiment);
a shaft extending distally from the handle, the shaft defining a guideway along which the blade is configured to travel (outer sheath 12’ housing blade 111’ therein, see Fig. 14);
wherein the guideway comprises a first portion with an incline (see Fig. 14 showing wherein the left-most portion of opening 121’ comprises an inclined surface), a second portion extending proximally from the first portion (see Fig. 14 showing wherein a flat portion extends proximally from the distal-most inclined surface of the opening 121’), and a third portion extending proximally from the second portion and having a decline (see Fig. 14 showing wherein the right-most portion of opening 121’ comprises an declined surface extending proximally from the flat second portion).
Since Barnes is silent regarding a disclosed shape of the guideway within which the blade is disposed, one of ordinary skill in the art would have looked to similar devices within the same field of endeavor to incorporate an adequate structure into the devices of Barnes. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the distal slot (232) of Barnes within which the blade protrudes from during actuation to comprise the inclined, sloping shape disclosed by Li to provide a known structure within the art. Since the blade shape of Li and Barnes are substantially similar (see Barnes Fig. 6 and Li Fig. 14) and comprise a shape that declines distally to a trough before inclining back to a peak, one of ordinary skill in the art would have expected the device of Barnes to function appropriately having the outer shaft cutting window be shaped in the form the sloped surface disclosed by Li. This shape also would match the shape of the cutting edge of the blade of Barnes as evident by the similar shape(s) of the blade of Barnes (see Fig. 6) and the shape of the outer shaft of Li (see Fig. 14).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnes (US 2019/0110851 A1) in view of Peh (US 2015/0190587 A1).
Regarding claim 11, Barnes discloses all of the limitations of the invention of claim 1.
However, Barnes does not provide an express disclosure of materials used to form the shaft and thus does not expressly disclose wherein the shaft has an elongate polymer portion defining the guideway and an elongate metal portion defining the guideway.
In the field of endeavor of elongate surgical tubular members configured to be navigated to a target site within the body, Peh teaches wherein a surgical device (see Fig. 3F) comprises an elongate tubular body (needle 100, see Fig. 3F) may have a proximal end formed from a combination of polymeric and metallic materials to achieve a desired flexibility and push-strength during navigation to a target site and/or during use (see Para. [0095], [0097] and [0099]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the shaft of Barnes to be made from a combination of polymeric and metallic materials as disclosed by Peh to achieve desired flexibility and push-strength during navigation to a target site and/or during use (see Para. [0095], [0097] and [0099]) and since it has been held that selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnes (US 2019/0110851 A1) in view of Jones (US 5514087 A).
Regarding claim 20, Barnes discloses all of the limitations of the invention of claim 19.
However, Barnes does not expressly disclose wherein the manifold comprises a pressure relief valve and a pressure relief chamber.
In the field of endeavor of pressure control within surgical devices, Jones teaches wherein a pressure relief valve may be included within a pressure-management system to, upon detecting an excessive pressure within the system, open and relieve any excess pressure from the main system into a separate relief chamber to be vented out from the system to prevent damage due to excess pressure (see Claim 1).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the inflation system of Barnes to include a relief valve and relief chamber therein as taught and suggested by Jones to, in this case, provide a pressure-management system configured to, upon detection of excess pressure within the inflation system, cause the pressure relief valve to open and remove inflation media from the main inflation system into a separate relief chamber, thereby reducing risk and damage to the device during an excess-pressure event (see Jones Claim 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2004/0024396 A1 to Eggers, US 2020/0146691 A1 to Rothstein, US 2020/0405344 A1 to Wilson US 2016/0081710 A1 to Barnes, US 2015/0265818 A1 to Piskun, US 2010/0100114 A1 to Berger, US 2009/0048620 A1 to Weiss, US 2006/0149136 A1 to Seto, and US 5865728 A to Moll all disclose surgical tissue cutting and/or expanding devices comprising inflatable balloons and cutting devices thereon and US 2017/0296212 A1 to Weijiang and US 2013/0018382 A1 to Jones disclose surgical cutting devices comprising over-center locking mechanisms for locking an actuator in a desired position.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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/M.B.H./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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