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 filed 3/13/2026 have been fully considered but they are not persuasive.
Regarding claims 1 and 13, Applicant contends that Barnes (US 2019/0110851 A1) (previously of record) does not expressly or adequately disclose or suggest the amended limitations of “a first anchor configured to move from an unactuated position to an over-center actuated position and a second actuator in communication with the first actuator and configured to slide longitudinally along the handle only when the first actuator is in the over-center actuated position, wherein the second actuator is locked and prevented from sliding along the handle in either direction when the first actuator is in the unactuated position” combined with “the first actuator remains locked in the over-center actuated position until the second actuator slides proximally along the handle to locate the blade in a proximal safe position” on the grounds that Barnes does not Barnes does not disclose this “double-lock” system.
While the Examiner acknowledges the prior art device of Barnes cites a common inventor to the presently-claimed invention, the Examiner respectfully disagrees with the interpretation that Barnes does not disclose this “double-lock” feature, as presently claimed. Barnes discusses in Para. [0046]-[0048] and [0070]-[0071] wherein when the device is initially inserted into a target region adjacent a transverse carpal ligament, the “second actuator” blade actuation system (i.e., blade actuator system 222) is locked and unable to translate the blade until the balloon inflation “first actuator” lever 216 is depressed such that the balloons 234a and 234 inflate. The lever is locked in this arrangement via engagement of spring-biased button 296 on the lever body and groove 299 on the handle body, thus preventing deflation of the balloons. Barnes discloses wherein once the lever is depressed and locked in the actuated position, this “unlocks” the blade actuation assembly to permit the blade to be translated along the longitudinal axis. Along with this, Barnes discloses that, during use, the lever remains in the locked, actuated position until the blade has been retracted proximally within the shaft body, at which time the lever is unlocked and released, causing the balloons to deflate. While Barnes is not specific as to a particular mechanism pertaining to this second locking mechanism, the device is configured to be used in such a manner as to functionally comprise the “double-lock” system as present claimed.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites, “when the first actuator is the unactuated position” and appears to be missing a recitation of “in” between the “is” and “the unactuated position”. Correction is suggested to place the claim language in better grammatical form.
Appropriate correction is required.
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 12-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barnes (US 2019/0110851 A1) (previously of record).
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) configured to move from an unactuated position to an over-center actuated position (see Para. [0043]-[0045] and [0048] mentioning wherein lever is configured to transition from an unactuated, relaxed state in which the lever is far away from the handle body such as shown in Fig. 5, and a depressed, actuated state in which the lever is depressed towards the handle body, appearing to pivot about the connection at distal end of the handle; during transition to the depressed, actuated state, the lever is depressed to move radially-inward toward the handle body and is thus moved toward the centroid of the handle to become “over-center” as the lever moves radially-inward to become substantially parallel to the handle body); and
a second actuator (blade actuator 222, see Figs. 5-6) in communication with the first actuator (see Para. [0070] mentioning wherein inflation of the balloon (via depressing lever 216) unlocks the cutting blade for actuation via blade actuator 222; a connection between the blade actuator and lever is understood to be present to allow the two components to communicate to facilitate such a sequential function) and configured to slide longitudinally along the handle (see Para. [0038], [0040] and [0048] mentioning wherein the blade actuator comprises a slider 270 (see Figs. 5-7) configured to slide along the longitudinal axis to cause proximal and distal translation of the blade) only when the first actuator is in the over-center actuated position (see Para. [0070] mentioning wherein depressing the lever 216 unlocks slider 270 to allow longitudinal movement thereof), wherein the second actuator is locked and preventing from sliding along the handle in either direction when the first actuator is in the unactuated position (see Para. [0070] mentioning wherein the slider 270 is locked until the lever 216 is depressed to an actuated position, thereby unlocking the slider);
an expansion device (inflation device 288, see Fig. 5 and Para. [0041]);
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), and defining a guideway along which the blade is configured to travel (see Para. [0033] and [0047]-[0048]) between a distal safe position and a proximal safe position to cut the body tissue (see Figs. 5-7 and Para. [0033] and [0047]-[0048]); and
at least one an expander (balloons 234a/234b, see Fig. 5) in fluid communication with the expansion device (see Para. [0044]) and extending along the shaft (see Fig. 5);
wherein moving the first actuator from the unactuated position to the over-center actuated position compacts the expansion device in the handle to cause fluid to travel through tubing in the shaft to expand the at least one expander to an expanded configuration (see Para. [0044]-[0045] mentioning wherein depressing lever 216 causes fluid to flow from inflation device 288 to the balloons 234a/234b via tubing passing through the shaft as shown in Figs. 5 and 7) and unlocks the second actuator to allow actuation of the second actuator and longitudinal movement of the blade along the guideway (see Para. [0070]) from the distal safe position to the proximal safe position to cut the body tissue (see Para. [0070]); and
wherein the first actuator remains locked in the over-center actuated position, thus preventing deflation of the expansion device (see Para. [0046] and [0070]-[0071] mentioning wherein depressing the lever causes spring-biased pin 296 of the lever to engage with groove 299 along the handle body to hold the lever in a depressed state), until the second actuator slides proximally along the handle to locate the blade in the proximal safe position (see Para [0046]-[0048] and [0070]-[0071] mentioning wherein, during use, once the blade is deployed via slider 270, the lever 216 is locked via spring-biased button 296 engaged with groove 299 until the blade is retracted back within the shaft).
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 the unactuated position in which the at least one expander is in an unexpanded configuration and a the over-center actuated position in which the at least one expander is in the expanded configuration (see Para. [0045]-[0047], [0067] and [0070] mentioning wherein when the lever 216 is relaxed and radially-away from the handle body, the balloons 234a/234b are deflated; depressing the lever towards the handle body causes the balloons to be inflated).
Regarding claim 3, Barnes discloses the invention of claim 2, Barnes further discloses wherein the first actuator is biased toward the unactuated position and is configured to remain in the over-center actuated position after the first actuator is adjusted to the over-center actuated position and the forces applied to the first actuator are removed (see Para. [0046]-[0047] and [0070]-[0071] mentioning wherein the lever 216 is depressed towards the actuated position such that spring-biased pin 296 engages groove 299 of the handle body to secure and lock the lever in the actuated position).
Regarding claim 4, Barnes discloses the invention of claim 1, Barnes further discloses wherein the at least one expander comprises two balloons disposed on the shaft (see Fig. 5 showing two balloons 234a/234b disposed along the shaft 220).
Regarding claim 5, Barnes discloses the invention of claim 1, Barnes further discloses 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 (inflation conduits 286a/286b, see Fig. 5 and Para. [0041]-[0045] and [0055]-[0056]).
Regarding claim 7, Barnes discloses the invention of claim 1, Barnes further discloses a linkage coupled with the first actuator and the second actuator (see Para. [0070]-[0071] mentioning wherein the blade actuation system is locked until actuation of lever 216, indicating a linkage between the two actuators that prevents movement of the blade actuation system until the lever is moved to the depressed, actuated state).
Regarding claim 9, Barnes discloses the invention of claim 1, Barnes further discloses a linkage extending between the first actuator and the second actuator (see Para. [0070]-[0071] mentioning wherein the blade actuation system is locked until actuation and depression 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 the over-center actuated position to unlock the second actuator and allow actuation of the second actuator to longitudinally move the blade along the guideway from the distal safe position to the proximal safe position (see Para. [0070]-[0071] mentioning wherein the blade actuation system is locked until actuation/depression of lever 216 which causes the blade actuation system to become unlocked and permit translation of the blade between a distal exposed position and a proximal retracted position).
Regarding claim 12, Barnes discloses the invention of claim 1, Barnes further discloses wherein the second actuator comprises 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 in a patient, the method comprising:
inserting a distal end of the device (see Fig. 5) into the patient to position a top surface of a shaft (shaft 220, see Fig. 5) of the device under the body tissue to be cut (see Para. [0035], [0047] and [0070]);
moving a first actuator on the handle of the device (lever 216, see Fig. 5) coupled with a proximal end of the shaft (see Fig. 5) from an unactuated position to an over-center actuated position (see Para. [0043]-[0045] and [0048] mentioning wherein lever is configured to transition from an unactuated, relaxed state in which the lever is far away from the handle body such as shown in Fig. 5, and a depressed, actuated state in which the lever is depressed towards the handle body, appearing to pivot about the connection at distal end of the handle; during transition to the depressed, actuated state, the lever is depressed to move radially-inward toward the handle body and is thus moved toward the centroid of the handle to become “over-center” as the lever moves radially-inward to become substantially parallel to the handle body) to radially enlarge an expander (balloon(s) 234a/234b; see Para. [0044]-[0045]) extending along a distal portion of the shaft (see Fig. 5) and unlock a second actuator on the handle (blade actuator 222, see Fig. 5; see Para. [0070]-[0071] mentioning wherein depressing the lever to the actuated position unlocks the blade actuator assembly to permit translation of the blade), wherein the second actuator is coupled with a blade disposed in the shaft (see Para. [0033], [0038] and [0070]); and
cutting the body tissue by sliding the second actuator proximally along the handle to move the blade from a distal protected position to a cutting position (see Para. [0048] mentioning wherein moving the slider proximally causes the blade to translate proximally, from an initial distal, non-cutting position, to cut the target transverse carpal ligament);
sliding the second actuator further proximally along the handle to move the blade from the cutting position to a proximal protected position (see Para. [0048]);
wherein the first actuator is locked in the over-center actuated position until the blade is in the proximal protected position, thus preventing the expander from deflating while the blade is in the cutting position (see Para. [0046]-[0048] and [0070]-[0071] mentioning wherein the lever 216 is locked in the actuated, “over-center” position such that the balloons 234a/234b remain inflated during the cutting procedure via engagement of spring-biased button 296 of the lever within groove 299 of the handle);
moving the first actuator from the over-center actuated position to the unactuated position to deflate the expander (see Para. [0046]-[0048] and [0070]-[0071]); and
removing the distal end of the device from the patient (see Para. [0048] and [0071]).
Regarding claim 14, Barnes discloses the method of claim 13, Barnes further discloses wherein the expander comprises two on the shaft (balloons 234a/234b, see Fig. 5), and the wherein 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 two balloons and radially enlarge the two balloons (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 wherein the body tissue comprises a transverse carpal ligament (see Para. [0047]-[0048] and [0070]-[0071]).
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) (previously of record) in view of Milsom (US 2020/0121168 A1) (previously of record).
Regarding claim 6, Barnes discloses all of the limitations of the invention of claim 1, Barnes further discloses wherein the handle further comprises a priming port (fill port 273, see Fig. 5) in fluid communication with the expansion device (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) (previously of record) in view of Malkowski (US 2011/0184459 A1) (previously of record).
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 fully actuated, depressed position (see Para. [0046]-[0047] and [0070]-[0071]) Barnes does not expressly disclose wherein the mechanism for locking the first actuator in the depressed position 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 actuator 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) of Barnes in actuated, depressed position 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) (previously of record) in view of Li (CN 115054323 A) (previously of record).
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) (previously of record) in view of Peh (US 2015/0190587 A1) (previously of record).
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)).
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 12004884 B2 to Barnes, US 2015/0201959 A1 to Guo, US 8702654 B2 to Agee, US 2014/0039533 A1 to Palmer and US 2014/0031621 A1 to Liu all disclose surgical tissue cutting and/or expanding devices comprising inflatable balloons and cutting devices thereon.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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