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
Claims filed on November 13th, 2025 have been entered. Claims 1-10, 12- 13, 16, 20, and 22- 25 are pending in the application. Claim 5 remains withdrawn for being directed to an unelected species.
The rejection of claims 1, 2, 6, 10 and 13 under 35 U.S.C. 103 over Banko (US 3,937,222) in view of Mackool (US 5,354,265) has been withdrawn in light of the amendment to claim 1, specifically Banko does not teach a friction reduction element or a plurality of ports arranged as an array on the exterior surface, the array being located on the longitudinal portion.
The rejection of claims 8-9 and 21 -23 under 35 U.S.C. 103 over Banko (US 3,937,222) in view of Mackool (US 5,354,265) in further view of Nguyen (US 2021/0212714) has been withdrawn in light of the amendment to claim 1, specifically Banko does not teach a friction reduction element or a plurality of ports arranged as an array on the exterior surface, the array being located on the longitudinal portion and the cancellation of claim 21.
The rejection of claim 12 under 35 U.S.C. 103 over Banko (US 3,937,222) in view of Mackool (US 5,354,265) in further view of Deng (US 2003/0135151) has been withdrawn in light of the amendment to claim 1, specifically Banko does not teach a friction reduction element or a plurality of ports arranged as an array on the exterior surface, the array being located on the longitudinal portion.
The rejection of claim 14 under 35 U.S.C. 103 over Banko (US 3,937,222) in view of Mackool (US 5,354,265) in further view of Flatt (WO 2018/075935) has been withdrawn in light of the cancellation of claim 14.
The rejection of claims 1-4, 7, 10, 13, 15, 16, and 20 under 35 U.S.C. 103 over Hancock et al. (WO 2021/083567) in view of Mackool (US 5,354,265) has been withdrawn in light of the amendment to claim 1, specifically Hancock does not teach a friction reduction element or a plurality of ports arranged as an array on the exterior surface, the array being located on the longitudinal portion.
The rejection of claims 8-9 and 21- 23 under 35 U.S.C. 103 over Hancock et al. (WO 2021/083567) in view of Mackool (US 5,354,265) in further view of Nguyen (US 2021/0212714) has been withdrawn in light of the amendment to claim 1, specifically Banko does not teach a friction reduction element or a plurality of ports arranged as an array on the exterior surface, the array being located on the longitudinal portion and the cancellation of claim 21.
The rejection of claim 12 under 35 U.S.C. 103 over Hancock et al. (WO 2021/083567) in view of Mackool (US 5,354,265) in further view of Deng (US 2003/0135151) has been withdrawn in light of the amendment to claim 1, specifically Banko does not teach a friction reduction element or a plurality of ports arranged as an array on the exterior surface, the array being located on the longitudinal portion.
The rejection of claim 14 under 35 U.S.C. 103 over Hancock et al. (WO 2021/083567) in view of Mackool (US 5,354,265) in further view of Flatt (WO 2018/075935) has been withdrawn in light of the cancellation of claim 14.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 6, 8- 10, 13, 16, 20, and 22 - 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banko (US 3,937,222) in view of Nguyen (US 2021/0212714) and in view of Vale (CN 113040865 English Translation).
Regarding claims 1 and 9, Banko teaches a guard (shield 45)(Figs. 1- 3) for a rotary tool (cutter 28)(abstract) configured to be rotatably driven by a surgical device (instrument 10)(Column 3, Lines 6- 21). It is noted that the claim only requires a guard for a rotary tool, and thus a rotary tool is not required by the claim, regardless, Banko teaches the rotary tool comprising an elongated member (spiral flute 63) and an energy applicator (burr 65) disposed at a distal end of the elongated member (Column 2, Lines 58- 61). Banko teaches the guard comprising:
A body (outer shield wall 45a, interior shield wall 45b)(Fig. 2) including: a proximal end and a distal end opposite the proximal end, the proximal end configured to connect to the surgical device (Column 2, Lines 30- 31, and Lines 40- 41) and a longitudinal portion located between the proximal end and the distal end (see annotated Fig. 2 below);
An interior surface (interior shield wall 45b) defining a bore (passage 50) extending between the proximal end and the distal end (see annotated Fig. 2 below) and the bore adapted to receive the elongated member therethrough (Column 2, Lines 50- 51);
An exterior surface (outer wall 45a) extending between the proximal end and the distal end and encompassing the interior surface between the proximal and the distal end (see annotated Fig. 2 below)(Column 2, Lines 41- 42); and
At least one thermal mitigation channel (passage 49)(As Banko teaches that fluid can travel through the passage 49 (Column 2, Lines 42- 48), when cool liquid is sent through the passage, the temperature of the device would decrease and therefore the passage would act as a thermal mitigation channel.) located between the interior surface and the exterior surface (Column 2, Lines 41- 42) extending a longitudinal length and opening through at least one port (opening 51) in the exterior surface (see annotated Fig. 2 below).
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Banko does not teach (claim 1) a friction reduction element configured to retain the elongated member therethrough, the friction reduction element defining a first longitudinal length, the at least one thermal mitigation channel adjacent to the friction reduction element and extending a second longitudinal length spanning at least the first longitudinal length, the at least one thermal mitigation channel opening through a plurality of ports arranged as an array on the exterior surface, the array being located on the longitudinal portion and being arranged within the second longitudinal length, wherein the at least one thermal mitigation channel and the plurality of ports are configured to dissipate heated air or gas from the body in response to the rotary tool being rotatably driven or (claim 9) wherein the friction reduction element is arranged as a sleeve disposed within the bore and coupled to the interior surface, wherein the sleeve defines a hole extending therethrough and concentric with the bore, with the hole having a diameter less than a diameter of the bore for spacing the elongated member from the interior surface and supporting the elongated member with the sleeve.
Nguyen teaches a similar guard (Figs. 1- 7)(Paragraphs 0026 and 0027) for a tool (74)(Paragraph 0027) with an elongated member (tool shaft 28), with a body (elongated tube 98, outer tube 100) with an interior surface defining a bore (99)(Paragraph 0033), an exterior surface (see annotated Fig. 6 below), and a channel (192)(Paragraph 0034). Nguyen further teaches wherein the interior surface is configured to receive a friction reduction element (bushing 240) for retaining the elongated member (Paragraph 0048), defining a first longitudinal length, and wherein the channel is located between the interior and exterior surfaces (see annotated Fig. 6 below) and wherein the friction reduction element is arranged as a sleeve disposed within the bore and coupled to the interior surface, wherein the sleeve defines a hole extending therethrough and concentric with the bore, and the hole having a diameter less than a diameter of the bore for spacing the elongated member from the interior surface and supporting the elongated member with the sleeve (Paragraph 0048).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard as taught by Banko to have the friction reduction element as taught by Nguyen, since Nguyen teaches that the bushing “may allow for a substantially smooth and low friction movement of the tool” (Paragraph 0048).
Regarding the at least one thermal mitigation channel being adjacent to the friction reduction element, as the thermal mitigation channel as taught by Banko extends throughout the guard (see Fig. 1), it would be adjacent to the friction reduction element.
Regarding the at least one thermal mitigation channel extending a second longitudinal length spanning at least the first longitudinal length, as Banko teaches that the thermal mitigation channel extends a longitudinal length from the distal end to the proximal end of the device (see annotated Fig. 2 of Banko below) and the friction reduction element would be located at the distal end of the device in the combination (see annotated Fig. 6 of Nguyen above), then the thermal mitigation channel would extend a second longitudinal length spanning the first longitudinal length.
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Banko and Nguyen do not teach the at least one thermal mitigation channel opening through a plurality of ports arranged as an array on the exterior surface, the array being located on the longitudinal portion and being arranged within the second longitudinal length, wherein the at least one thermal mitigation channel and the plurality of ports are configured to dissipate heated air or gas from the body in response to the rotary tool being rotatably driven.
Vale teaches a similar guard (catheter 100)(Figs. 1- 2D)(Paragraphs 0032- 0034) for use with a surgical device (Paragraph 0032) the guard having a body with a distal end, an interior surface defining a bore, an exterior surface encompassing the interior surface, a channel (supply passage 120, annular expansion chamber 122) located between the interior surface and the exterior surface opening through a plurality of ports (openings 125) arranged as an array on the exterior surface, the array being located on the longitudinal portion and being arranged within a longitudinal length of the exterior surface (see annotated Fig. 2C below). Regarding the channel and the plurality of ports are configured to dissipate heated air or gas from the body during a procedure, as this language is functional, the structure of the device only needs to be able to accomplish the function, therefore as Vale teaches in Paragraph 0034 that the openings and the channel are capable of distributing saline, when there is no saline, they would be able to dissipate air through the openings during a procedure.
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard of the combination to have the plurality of ports arranged as an array on the exterior surface as taught by Vale, since Vale teaches that the plurality of ports aids in minimizing “friction with the vessel wall”, minimizing “damage to surrounding tissues”, and aids in navigation (Paragraph 0034).
Regarding claim 2, Banko, Nguyen and Vale make obvious the guard as discussed above for claim 1.
Banko further teaches wherein the at least one thermal mitigation channel is defined in a substantially annular configuration about the bore (see annotated Fig. 2 below)(Column 2, Lines 41- 42 and Lines 48- 51).
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Regarding claim 6, Banko, Nguyen, and Vale make obvious the guard as discussed above for claim 1.
Banko further teaches wherein the exterior surface defines a passage adjacent the distal end of the monolithic body, with the thermal mitigation channel opening through both of the at least one port and the passage (see annotated Fig. 2 below)(Column 2, Lines 41- 45).
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Regarding the thermal mitigation channel opening through both of the plurality of ports and the passage, as the combination now has multiple ports that are connected to a channel (see annotated Fig. 2C of Vale above), it would have been obvious for the thermal mitigation channel to open through both of the plurality of ports and the passage.
Regarding claim 8, Banko, Nguyen and Vale make obvious the guard as discussed above for claim 1.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard as taught by Banko to have the friction reduction element as taught by Nguyen, since Nguyen teaches that the bushing “may allow for a substantially smooth and low friction movement of the tool” (Paragraph 0048).
The combination further teaches wherein the second longitudinal length is greater than the first longitudinal length (As the channel of Banko and therefore the second longitudinal length extends to the distal end and the proximal end of the device (see annotated Fig. 2 of Banko below), and the first longitudinal length of Nguyen does not extend to the proximal end of the device (see annotated Fig. 6 of Nguyen below), the second longitudinal length would be greater than the first longitudinal length.).
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Regarding claim 10, Banko, Nguyen and Vale make obvious the guard as discussed above for claim 1.
The claimed phrase formed by additive manufacturing is a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. Additive manufacturing is 3D printing, thus, in the instant case, the recitation of additive processing would impart the presence monolithic formed body to the claimed product.
Banko teaches a monolithic body (outer shield wall 45a, interior shield wall 45b)(Fig. 2)(As Banko teaches that the body of the shield is made of two concentric walls (Column 2, Lines 41- 42) and shows in Fig. 2 that the two walls are connected (see annotated Fig. 2 below), the body is monolithic.) and therefore has substantially the same or similar structure set forth in the claim.
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Regarding claim 13, Banko, Nguyen, and Vale make obvious the guard as discussed above for claim 1.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard as taught by Banko to have the friction reduction element as taught by Nguyen, since Nguyen teaches that the bushing “may allow for a substantially smooth and low friction movement of the tool” (Paragraph 0048).
The combination further teaches wherein the friction reduction element has an annular configuration (Nguyen, Paragraph 0045, see Fig. 6) and the at least one thermal mitigation channel is disposed annularly about the friction reduction element (As the mitigation channel of Banko is annularly disposed about the bore of the interior surface (Column 2, Lines 41- 51), then the thermal mitigation channel would be disposed annularly about the friction reduction element.).
Regarding claim 16, Banko, Nguyen, and Vale make obvious the guard as discussed above for claim 1.
Regarding wherein, in response to the rotary tool being rotatably driven, the at least one thermal mitigation channel and the plurality of ports are further configured to dissipate heated air or gas generated by the friction reduction element, as this language is functional, the structure of the device only needs to be able to accomplish the function, therefore as Vale teaches in Paragraph 0034 that the openings and the channel are capable of distributing saline, when there is no saline, they would be able to dissipate air through the openings during a procedure and Banko teaches that the at least one thermal mitigation channel extends from the distal end to the proximal end (see annotated Fig. 2 of Banko) and therefore is able to dissipate the heated air throughout the device.
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Regarding claim 20, Banko, Nguyen, and Mackool make obvious the guard as discussed above in claim 1.
Banko further teaches wherein the exterior surface has an annular configuration (Column 2, Lines 41- 43)(see Fig. 2).
Regarding claim 22, Banko, Nguyen, and Mackool make obvious the guard as discussed above in claim 1.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard of the combination to have the plurality of ports arranged as an array on the exterior surface as taught by Vale, since Vale teaches that the plurality of ports aids in minimizing “friction with the vessel wall”, minimizing “damage to surrounding tissues”, and aids in navigation (Paragraph 0034).
The combination further teaches wherein the plurality of ports comprise at least six ports with each port being spaced apart and separated from the other ports (see annotated Fig. 2C of Vale below).
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Regarding claim 23, Banko, Nguyen, and Mackool make obvious the guard as discussed above in claim 9.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard as taught by Banko to have the friction reduction element as taught by Nguyen, since Nguyen teaches that the bushing “may allow for a substantially smooth and low friction movement of the tool” (Paragraph 0048). The combination further teaches wherein the friction reduction element (Nguyen, 240), which is a bushing (Nguyen, Paragraph 0045), is arranged as a sleeve disposed within the bore and coupled to the interior surface, wherein the sleeve defines a hole extending therethrough and concentric with the bore, and the hole having a diameter less than a diameter of the bore for spacing the elongated member from the interior surface and supporting the elongated member with the sleeve (Nguyen, Paragraph 0048).
Regarding claim 24, Banko teaches a surgical system (Figs. 1-3) comprising: a rotary tool (cutter 28)(abstract) comprising an elongated member (spiral flute 63) and an energy applicator (burr 65) disposed at a distal end of the elongated member (Column 2, Lines 58- 61);
A surgical device (instrument 10) configured to receive and rotatably drive the rotary tool (Column 3, Lines 6- 21); and
A guard (shield 45)(Figs. 1- 3) for a rotary tool (cutter 28)(abstract), the guard comprising:
A body (outer shield wall 45a, interior shield wall 45b)(Fig. 2) including: a proximal end and a distal end opposite the proximal end, the proximal end configured to connect to the surgical device (Column 2, Lines 30- 31, and Lines 40- 41) and a longitudinal portion located between the proximal end and the distal end (see annotated Fig. 2 below);
An interior surface (interior shield wall 45b) defining a bore (passage 50) extending between the proximal end and the distal end (see annotated Fig. 2 below) and the bore adapted to receive the elongated member therethrough (Column 2, Lines 50- 51);
An exterior surface (outer wall 45a) extending between the proximal end and the distal end and encompassing the interior surface between the proximal and the distal end (see annotated Fig. 2 below)(Column 2, Lines 41- 42); and
At least one thermal mitigation channel (passage 49)(As Banko teaches that fluid can travel through the passage 49 (Column 2, Lines 42- 48), when cool liquid is sent through the passage, the temperature of the device would decrease and therefore the passage would act as a thermal mitigation channel.) located between the interior surface and the exterior surface (Column 2, Lines 41- 42) extending a longitudinal length and opening through at least one port (opening 51) in the exterior surface (see annotated Fig. 2 below).
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Banko does not teach a friction reduction element configured to retain the elongated member therethrough, the friction reduction element defining a first longitudinal length the at least one thermal mitigation channel adjacent to the friction reduction element and extending a second longitudinal length spanning at least the first longitudinal length, wherein the friction reduction element is arranged as a sleeve disposed within the bore and coupled to the interior surface, wherein the sleeve defines a hole extending therethrough and concentric with the bore, with the hole having a diameter less than a diameter of the bore for spacing the elongated member from the interior surface and supporting the elongated member with the sleeve, the at least one thermal mitigation channel opening through a plurality of ports arranged as an array on the exterior surface, the array being located on the longitudinal portion and being arranged within the second longitudinal length, wherein the at least one thermal mitigation channel and the plurality of ports are configured to dissipate heated air or gas from the body in response to the rotary tool being rotatably driven.
Nguyen teaches a similar guard (Figs. 1- 7)(Paragraphs 0026 and 0027) for a tool (74)(Paragraph 0027) with an elongated member (tool shaft 28), with a body (elongated tube 98, outer tube 100) with an interior surface defining a bore (99)(Paragraph 0033), an exterior surface (see annotated Fig. 6 below), and a channel (192)(Paragraph 0034). Nguyen further teaches wherein the interior surface is configured to receive a friction reduction element (bushing 240) for retaining the elongated member (Paragraph 0048), defining a first longitudinal length, and wherein the channel is located between the interior and exterior surfaces (see annotated Fig. 6 below) and wherein the friction reduction element is arranged as a sleeve disposed within the bore and coupled to the interior surface, wherein the sleeve defines a hole extending therethrough and concentric with the bore, and the hole having a diameter less than a diameter of the bore for spacing the elongated member from the interior surface and supporting the elongated member with the sleeve (Paragraph 0048).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard as taught by Banko to have the friction reduction element as taught by Nguyen, since Nguyen teaches that the bushing “may allow for a substantially smooth and low friction movement of the tool” (Paragraph 0048).
Regarding the at least one thermal mitigation channel being adjacent to the friction reduction element, as the thermal mitigation channel as taught by Banko extends throughout the guard (see Fig. 1), it would be adjacent to the friction reduction element.
Regarding the at least one thermal mitigation channel extending a second longitudinal length spanning at least the first longitudinal length, as Banko teaches that the thermal mitigation channel extends a longitudinal length from the proximal end to the distal end of the device (see annotated Fig. 2 of Banko below) and the friction reduction element would be located at the distal end of the device in the combination (see annotated Fig. 6 of Nguyen above), then the thermal mitigation channel would extend a second longitudinal length spanning the first longitudinal length.
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Banko and Nguyen do not teach the at least one thermal mitigation channel opening through a plurality of ports arranged as an array on the exterior surface, the array being located on the longitudinal portion and being arranged within the second longitudinal length, wherein the at least one thermal mitigation channel and the plurality of ports are configured to dissipate heated air or gas from the body in response to the rotary tool being rotatably driven.
Vale teaches a similar guard (catheter 100)(Figs. 1- 2D)(Paragraphs 0032- 0034) for use with a surgical device (Paragraph 0032) the guard having a body with a distal end, an interior surface defining a bore, an exterior surface encompassing the interior surface, a channel (supply passage 120, annular expansion chamber 122) located between the interior surface and the exterior surface opening through a plurality of ports (openings 125) arranged as an array on the exterior surface, the array being located on the longitudinal portion and being arranged within a longitudinal length of the exterior surface (see annotated Fig. 2C below). Regarding the channel and the plurality of ports are configured to dissipate heated air or gas from the body during a procedure, as this language is functional, the structure of the device only needs to be able to accomplish the function, therefore as Vale teaches in Paragraph 0034 that the openings and the channel are capable of distributing saline, when there is no saline, they would be able to dissipate air through the openings during a procedure.
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard of the combination to have the plurality of ports arranged as an array on the exterior surface as taught by Vale, since Vale teaches that the plurality of ports aids in minimizing “friction with the vessel wall”, minimizing “damage to surrounding tissues”, and aids in navigation (Paragraph 0034).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banko (US 3,937,222) in view of Nguyen (US 2021/0212714) and Vale (CN 113040865 English Translation), as applied to claim 1 above, in further view of Deng (US 2003/0135151).
Regarding claim 12, Banko, Nguyen, and Vale make obvious the guard as discussed above for claim 1.
The combination of Banko Nguyen, and Vale does not teach wherein the at least one port comprises a teardrop configuration.
Deng teaches a device (handpiece 20, surgical cutting accessory 24)(Figs. 1- 6) for a surgery (abstract) that has a passage (46) with a port (62)(Fig. 4) that allows for flow to occur through it (Paragraphs 0030- 0031). The port has a teardrop shape (Paragraph 0038).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the at least one port as taught by Banko to have a teardrop configuration as taught by Deng, for the purpose of allowing flow while the device is activated. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one port shape for the other because both shapes are disclosed as equivalent structures for providing an opening for flow to go through (Banko, Column 3, Lines 22- 25; Deng, Paragraphs 0030- 0031) and shape and substitution of one for the other would have resulted in the predictable result of providing an opening for liquid to flow through (Banko, Column 3, Lines 22- 25; Deng, Paragraphs 0030- 0031). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banko (US 3,937,222) in view of Nguyen (US 2021/0212714) and Vale (CN 113040865 English Translation), as applied to claim 1 above, in further view of Flatt (WO 2018/075935).
Regarding claim 25, Banko teaches a surgical system (Figs. 1-3) comprising: a rotary tool (cutter 28)(abstract) comprising an elongated member (spiral flute 63) and an energy applicator (burr 65) disposed at a distal end of the elongated member (Column 2, Lines 58- 61);
A surgical device (instrument 10) configured to receive and rotatably drive the rotary tool (Column 3, Lines 6- 21); and
A guard (shield 45)(Figs. 1- 3) for a rotary tool (cutter 28)(abstract), the guard comprising:
A body (outer shield wall 45a, interior shield wall 45b)(Fig. 2) including: a proximal end and a distal end opposite the proximal end, the proximal end configured to connect to the surgical device (Column 2, Lines 30- 31, and Lines 40- 41) and a longitudinal portion located between the proximal end and the distal end (see annotated Fig. 2 below);
An interior surface (interior shield wall 45b) defining a bore (passage 50) extending between the proximal end and the distal end (see annotated Fig. 2 below) and the bore adapted to receive the elongated member therethrough (Column 2, Lines 50- 51);
An exterior surface (outer wall 45a) extending between the proximal end and the distal end and encompassing the interior surface between the proximal and the distal end (see annotated Fig. 2 below)(Column 2, Lines 41- 42); and
At least one thermal mitigation channel (passage 49)(As Banko teaches that fluid can travel through the passage 49 (Column 2, Lines 42- 48), when cool liquid is sent through the passage, the temperature of the device would decrease and therefore the passage would act as a thermal mitigation channel.) located between the interior surface and the exterior surface (Column 2, Lines 41- 42) extending a longitudinal length and opening through at least one port (opening 51) in the exterior surface (see annotated Fig. 2 below).
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Banko does not teach a friction reduction element configured to retain the elongated member therethrough, the friction reduction element defining a first longitudinal length the at least one thermal mitigation channel adjacent to the friction reduction element and extending a second longitudinal length spanning at least the first longitudinal length, wherein the friction reduction element is arranged as a sleeve disposed within the bore and coupled to the interior surface, wherein the sleeve defines a hole extending therethrough and concentric with the bore, with the hole having a diameter less than a diameter of the bore for spacing the elongated member from the interior surface and supporting the elongated member with the sleeve, the at least one thermal mitigation channel opening through a plurality of ports arranged as an array on the exterior surface, the array being located on the longitudinal portion and being arranged within the second longitudinal length, wherein the at least one thermal mitigation channel and the plurality of ports are configured to dissipate heated air or gas from the body in response to the rotary tool being rotatably driven.
Nguyen teaches a similar guard (Figs. 1- 7)(Paragraphs 0026 and 0027) for a tool (74)(Paragraph 0027) with an elongated member (tool shaft 28), with a body (elongated tube 98, outer tube 100) with an interior surface defining a bore (99)(Paragraph 0033), an exterior surface (see annotated Fig. 6 below), and a channel (192)(Paragraph 0034). Nguyen further teaches wherein the interior surface is configured to receive a friction reduction element (bushing 240) for retaining the elongated member (Paragraph 0048), defining a first longitudinal length, and wherein the channel is located between the interior and exterior surfaces (see annotated Fig. 6 below) and wherein the friction reduction element is arranged as a sleeve disposed within the bore and coupled to the interior surface, wherein the sleeve defines a hole extending therethrough and concentric with the bore, and the hole having a diameter less than a diameter of the bore for spacing the elongated member from the interior surface and supporting the elongated member with the sleeve (Paragraph 0048).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard as taught by Banko to have the friction reduction element as taught by Nguyen, since Nguyen teaches that the bushing “may allow for a substantially smooth and low friction movement of the tool” (Paragraph 0048).
Regarding the at least one thermal mitigation channel being adjacent to the friction reduction element, as the thermal mitigation channel as taught by Banko extends throughout the guard (see Fig. 1), it would be adjacent to the friction reduction element.
Regarding the at least one thermal mitigation channel extending a second longitudinal length spanning at least the first longitudinal length, as Banko teaches that the thermal mitigation channel extends a longitudinal length from the distal end of the device (see annotated Fig. 2 of Banko below) and the friction reduction element would be located at the distal end of the device in the combination (see annotated Fig. 6 of Nguyen above), then the thermal mitigation channel would extend a second longitudinal length spanning the first longitudinal length.
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Banko and Nguyen do not teach the at least one thermal mitigation channel opening through a plurality of ports arranged as an array on the exterior surface, the array being located on the longitudinal portion and being arranged within the second longitudinal length, wherein the at least one thermal mitigation channel and the plurality of ports are configured to dissipate heated air or gas from the body in response to the rotary tool being rotatably driven.
Vale teaches a similar guard (catheter 100)(Figs. 1- 2D)(Paragraphs 0032- 0034) for use with a surgical device (Paragraph 0032) the guard having a body with a distal end, an interior surface defining a bore, an exterior surface encompassing the interior surface, a channel (supply passage 120, annular expansion chamber 122) located between the interior surface and the exterior surface opening through a plurality of ports (openings 125) arranged as an array on the exterior surface, the array being located on the longitudinal portion and being arranged within a longitudinal length of the exterior surface (see annotated Fig. 2C below). Regarding the channel and the plurality of ports are configured to dissipate heated air or gas from the body during a procedure, as this language is functional, the structure of the device only needs to be able to accomplish the function, therefore as Vale teaches in Paragraph 0034 that the openings and the channel are capable of distributing saline, when there is no saline, they would be able to dissipate air through the openings during a procedure.
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard of the combination to have the plurality of ports arranged as an array on the exterior surface as taught by Vale, since Vale teaches that the plurality of ports aids in minimizing “friction with the vessel wall”, minimizing “damage to surrounding tissues”, and aids in navigation (Paragraph 0034).
The combination does not teach a surgical robot configured to support and move the surgical device.
Flatt teaches a robotic system (10)(Figs. 1- 10) comprising a similar guard (80) for a tool (energy applicator 24) that is configured to be actuated by a surgical device (tool 20)(Paragraph 0060), and a surgical manipulator (14) comprising a plurality of links and joints (16, 18) being configured to support the surgical device (Paragraph 0049).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the tool and surgical device as taught by the combination that uses a cutter to treat tissue (Column 1, Lines 27- 32) for the robotic system as taught by Flatt since these mechanisms perform the same function of treating tissue (Hancock, Page 1, Lines 5- 9; Page 3, Lines 6- 10; Flatt, Paragraph 0048) and since Flatt teaches that surgeons prefer to use robotic systems (Paragraph 0003). Simply substituting one surgical device and tool for another would yield the predicable result of treating the tissue of a patient. See MPEP 2143.
Rejections over the primary reference Hancock
Claim(s) 1-4, 7-9, 13, 15, 16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hancock et al. (WO 2021/083567) in view of Nguyen (US 2021/0212714) and Vale (CN 113040865 English Translation).
Regarding claims 1, 2, 3, 4, and 9, Hancock teaches a guard for a tool (Fig. 5). Hancock further teaches the guard having a body (tubular member 502)(Fig. 5)(Page 26, Lines 9- 11) including a proximal end and a distal end opposite the proximal end (Page 26, Lines 25- 28), the proximal end configured to connect to the surgical device (Page 26, Lines 13- 15), and a longitudinal portion located between the proximal end and the distal end (Page 26, Lines 9- 34), with an interior surface (inner wall 512) defining a bore (lumen 504) extending between the proximal end and the distal end that is adapted to have the tool inserted into it (Page 26, Lines 13- 15), an exterior surface (sidewall 510) encompassing the interior surface (see annotated Fig. 5 below) and two thermal mitigation channels (first annular channel 506, second annular channel 508) that surround the bore in a substantially annular configuration about the bore (Page 26, Lines 18- 21) and are spaced from and adjacent to one another through an intermediate wall (separation wall 514) extending between the two channels (Page 26, Lines 23- 28). The intermediate wall further defines a hole extending therethrough to fluidly connect the two channels (Page 26, Lines 28- 32).
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Regarding the guard being for a rotary tool, the rotary tool configured to be rotatably driven by a surgical device, it is noted that the limitation is recited in the preamble and is intended use, and thus the structure required to perform the use has been considered and the tool is not required by the claim. As Hancock teaches that the guard can be used to cover a tool that transfers energy to tissue (abstract, Page 26, Lines 13- 15), the guard of Hancock can be used in conjunction with a rotary tool.
Hancock is silent to the port on the exterior surface as recited in claim 1, however Hancock teaches that the inlet, i.e. port for the coolant, is disposed “near a proximal end of the tubular member” and the outlet, i.e. a port for the coolant output, is located “near the proximal end” (Page 26, Line 35 through Page 27, Line 12), thus to have the port in an area “near” the end, including a sidewall of the channel near the end, would have been an obvious suggestion of the prior art. The position of the office is further supported as H shows in Figure 7, that the side wall can have a hole (hole 726). Likewise, as the ports for coolant input and output disperses liquid to the channels (Page 26, Line 35 through Page 27, Line 12), they are fluidly connected to the channels.
Hancock does not teach (claim 1) a friction reduction element configured to retain the elongated member therethrough, the friction reduction element defining a first longitudinal length, the at least one thermal mitigation channel adjacent to the friction reduction element and extending a second longitudinal length spanning at least the first longitudinal length, the at least one thermal mitigation channel opening through a plurality of ports arranged as an array on the exterior surface, the array being located on the longitudinal portion and being arranged within the second longitudinal length, wherein the at least one thermal mitigation channel and the plurality of ports are configured to dissipate heated air or gas from the body in response to the rotary tool being rotatably driven or (claim 9) wherein the friction reduction element is arranged as a sleeve disposed within the bore and coupled to the interior surface, wherein the sleeve defines a hole extending therethrough and concentric with the bore, with the hole having a diameter less than a diameter of the bore for spacing the elongated member from the interior surface and supporting the elongated member with the sleeve.
Nguyen teaches a similar guard (Figs. 1- 7)(Paragraphs 0026 and 0027) for a tool (74)(Paragraph 0027) with an elongated member (tool shaft 28), with a body (elongated tube 98, outer tube 100) with an interior surface defining a bore (99)(Paragraph 0033), an exterior surface (see annotated Fig. 6 below), and a channel (192)(Paragraph 0034). Nguyen further teaches wherein the interior surface is configured to receive a friction reduction element (bushing 240) for retaining the elongated member (Paragraph 0048), defining a first longitudinal length, and wherein the channel is located between the interior and exterior surfaces (see annotated Fig. 6 below) and wherein the friction reduction element is arranged as a sleeve disposed within the bore and coupled to the interior surface, wherein the sleeve defines a hole extending therethrough and concentric with the bore, and the hole having a diameter less than a diameter of the bore for spacing the elongated member from the interior surface and supporting the elongated member with the sleeve (Paragraph 0048).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard as taught by Hancock to have the friction reduction element as taught by Nguyen, since Nguyen teaches that the bushing “may allow for a substantially smooth and low friction movement of the tool” (Paragraph 0048).
Regarding the at least one thermal mitigation channel being adjacent to the friction reduction element, as the thermal mitigation channel as taught by Hancock extends throughout the guard (Page 26, Lines 16- 34), it would be adjacent to the friction reduction element.
Regarding the at least one thermal mitigation channel extending a second longitudinal length spanning at least the first longitudinal length, as Hancock teaches that the thermal mitigation channel extends a longitudinal length from the distal end of the device (Page 26, Lines 16- 34) and the friction reduction element would be located at the distal end of the device in the combination (see annotated Fig. 6 of Nguyen above), then the thermal mitigation channel would extend a second longitudinal length spanning the first longitudinal length.
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Hancock and Nguyen do not teach the at least one thermal mitigation channel opening through a plurality of ports arranged as an array on the exterior surface, the array being located on the longitudinal portion and being arranged within the second longitudinal length, wherein the at least one thermal mitigation channel and the plurality of ports are configured to dissipate heated air or gas from the body in response to the rotary tool being rotatably driven.
Vale teaches a similar guard (catheter 100)(Figs. 1- 2D)(Paragraphs 0032- 0034) for use with a surgical device (Paragraph 0032) the guard having a body with a distal end, an interior surface defining a bore, an exterior surface encompassing the interior surface, a channel (supply passage 120, annular expansion chamber 122) located between the interior surface and the exterior surface opening through a plurality of ports (openings 125) arranged as an array on the exterior surface, the array being located on the longitudinal portion and being arranged within a longitudinal length of the exterior surface (see annotated Fig. 2C below). Regarding the channel and the plurality of ports are configured to dissipate heated air or gas from the body during a procedure, as this language is functional, the structure of the device only needs to be able to accomplish the function, therefore as Vale teaches in Paragraph 0034 that the openings and the channel are capable of distributing saline, when there is no saline, they would be able to dissipate air through the openings during a procedure.
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard of the combination to have the plurality of ports arranged as an array on the exterior surface as taught by Vale, since Vale teaches that the plurality of ports aids in minimizing “friction with the vessel wall”, minimizing “damage to surrounding tissues”, and aids in navigation (Paragraph 0034).
Regarding claim 7, Hancock, Nguyen, and Vale make obvious the guard as discussed above for claim 1.
The combination of Hancock, Nguyen, and Vale does not teach in the current embodiment wherein the at least one thermal mitigation channel comprises a proximal thermal mitigation channel adjacent the proximal end of the body and a distal thermal mitigation channel adjacent the distal end of the body and separated from the proximal thermal mitigation channel.
Hancock (Hancock et al.) teaches in a second embodiment, a guard (introducer 300)(Fig. 3) for a tool (transmission line 324, radiating tip 326), the tool comprising an elongated member (transmission line 324) and an energy applicator (radiating tip 326), the guard comprising: a body (tubular member 302), an interior surface defining a bore (lumen 304) and the bore adapted to receive the elongated member therethrough (Page 23, Line 40- Page 24, Line 4), an exterior surface extending between the proximal end and the distal end and encompassing the interior surface between the proximal and the distal end (see annotated Fig. 3 below), and two thermal mitigation channels (310, 312)(Page 24, Lines 9- 14). Hancock further teaches wherein the at least one thermal mitigation channel comprises a proximal thermal mitigation channel adjacent the proximal end of the monolithic body and a distal thermal mitigation channel adjacent the distal end of the monolithic body (see annotated Fig. 3 below) and separated from the proximal thermal mitigation channel (As the channels of which the proximal and distal thermal mitigation channels are physically separate (see Fig. 3), the proximal and distal thermal mitigation channels are considered separate.).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard as taught by the combination to have a proximal thermal mitigation channel adjacent the proximal end and a distal thermal mitigation channel adjacent the distal end as taught by the second embodiment of Hancock, since Hancock teaches that this configuration allows for the body of the guard to be “maintained at a safe temperature, to avoid damage to surrounding tissue” (Page 24, Lines 9- 14).
Regarding claim 8, Hancock, Nguyen, and Vale make obvious the guard as discussed above for claim 1.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard as taught by Hancock to have the friction reduction element as taught by Nguyen, since Nguyen teaches that the bushing “may allow for a substantially smooth and low friction movement of the tool” (Paragraph 0048).
The combination further teaches wherein the second longitudinal length is greater than the first longitudinal length (As the channel of Hancock and therefore the second longitudinal length extends to the distal end of the device (Page 26, Lines 16- 34), and the first longitudinal length of Vale does not extend to the distal end of the device (see annotated Fig. 6 of Nguyen below), the second longitudinal length would be greater than the first longitudinal length.).
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Regarding claim 10, Hancock and Mackool make obvious the guard as discussed above for claim 1.
The claimed phrase formed by additive manufacturing is a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. Additive manufacturing is 3D printing, thus, in the instant case, the recitation of additive processing would impart the presence monolithic formed body to the claimed product.
Hancock teaches a monolithic body (Hancock teaches on Page 26, Lines 11- 12 that the tubular member is a tube and therefore it is a monolithic body as it is in one piece.) and therefore has substantially the same or similar structure set forth in the claim.
Regarding claim 13, Hancock, Nguyen, and Vale make obvious the guard as discussed above for claim 1.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard as taught by Hancock to have the friction reduction element as taught by Nguyen, since Nguyen teaches that the bushing “may allow for a substantially smooth and low friction movement of the tool” (Paragraph 0048).
The combination further teaches wherein the friction reduction element has an annular configuration (Nguyen, Paragraph 0045, see Fig. 6) and the at least one thermal mitigation channel is disposed annularly about the friction reduction element (As Hancock teaches that the thermal mitigation channel is a part of a tubular catheter (Page 26, Lines 16- 34), then the thermal mitigation channel would be disposed annularly about the friction reduction element.).
Regarding claim 16, Hancock, Nguyen, and Vale make obvious the guard as discussed above in claim 1.
Regarding wherein, in response to the rotary tool being rotatably driven, the at least one thermal mitigation channel and the plurality of ports are further configured to dissipate heated air or gas generated by the friction reduction element, as this language is functional, the structure of the device only needs to be able to accomplish the function, therefore as Vale teaches in Paragraph 0034 that the openings and the channel are capable of distributing saline, when there is no saline, they would be able to dissipate air through the openings during a procedure and Hancock teaches that the at least one thermal mitigation channel extends to the distal end (Page 26, Lines 16- 34) and therefore is able to dissipate the heated air throughout the device.
Regarding claim 20, Hancock, Nguyen, and Vale make obvious the guard as discussed above in claim 1.
Hancock further teaches wherein the exterior surface has an annular configuration (Page 26, Lines 9- 34).
Regarding claim 22, Hancock, Nguyen, and Vale make obvious the guard as discussed above in claim 1.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard of the combination to have the plurality of ports arranged as an array on the exterior surface as taught by Vale, since Vale teaches that the plurality of ports aids in minimizing “friction with the vessel wall”, minimizing “damage to surrounding tissues”, and aids in navigation (Paragraph 0034).
The combination further teaches wherein the plurality of ports comprise at least six ports with each port being spaced apart and separated from the other ports (see annotated Fig. 2C of Vale below).
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Regarding claim 23, Hancock, Nguyen, and Vale make obvious the guard as discussed above in claim 9.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guard as taught by Hancock to have the friction reduction element as taught by Nguyen, since Nguyen teaches that the bushing “may allow for a substantially smooth and low friction movement of the tool” (Paragraph 0048). The combination further teaches wherein the friction reduction element (Nguyen, 240), which is a bushing (Nguyen, Paragraph 0045), is arranged as a sleeve disposed within the bore and coupled to the interior surface, wherein the sleeve defines a hole extending therethrough and concentric with the bore, and the hole having a diameter less than a diameter of the bore for spacing the elongated member from the interior surface and supporting the elongated member with the sleeve (Nguyen, Paragraph 0048).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hancock et al. (WO 2021/083567) in view of Nguyen (US 2021/0212714) and Vale (CN 113040865 English Translation), as applied to claim 1, in further view of Deng (US 2003/0135151).
Regarding claim 12, Hancock, Nguyen, and Vale make obvious the guard as discussed above for claim 1.
The combination of Hancock, Nguyen, and Vale does not teach wherein the at least one port comprises a teardrop configuration.
Deng teaches a device (handpiece 20, surgical cutting accessory 24)(Figs. 1- 6) for a surgery (abstract) that has a passage (46) with a port (62)(Fig. 4) that allows for flow to occur through it (Paragraphs 0030- 0031). The port has a teardrop shape (Paragraph 0038).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the at least one port as taught by the combination to have a teardrop configuration as taught by Deng, for the purpose of allowing flow while the device is activated. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one port shape for the other because both shapes are disclosed as equivalent structures for providing an opening for flow to go through (Hancock, Page 26, Line 35- Page 27, Line 18; Deng, Paragraphs 0030- 0031) and shape and substitution of one for the other would have resulted in the predictable result of providing an opening for liquid to flow through (Hancock, Page 26, Line 35- Page 27, Line 18; Deng, Paragraphs 0030- 0031). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Response to Arguments
Applicant’s arguments, see Pages 8- 14, filed November 13th, 2025, with respect to the previous rejections have been fully considered and are persuasive. The rejections have been withdrawn as discussed above. It is noted that Banko, Hancock, Nguyen, Deng, and Flatt are still relied upon for the rejection.
Regarding applicant’s argument, see Pages 10- 11, that the prior art fails to teach or suggest at least one thermal mitigation channel located adjacent to the friction reduction element and extending a second longitudinal length spanning at least the first longitudinal length of the friction reduction element, this argument has been fully considered but is not persuasive. For the combination, the friction reduction element would be placed within the bore of the interior surface of Banko or Hancock at the distal end. As Banko teaches that the thermal mitigation channel extends to the distal end of the device (see annotated Fig. 2 of Banko below), and Hancock teaches the same (Page 26, Lines 16- 34), then for both of these combinations with Nguyen, the thermal mitigation channel would be adjacent to the friction reduction element.
Regarding applicant’s argument, see Pages 13- 14, that the prior art fails to teach or suggest the at least one thermal mitigation channel and the plurality of ports are configured to dissipate heated air or gas from the body in response to the rotary tool being rotatably drive, as discussed above, this language is functional and as this language is functional, the structure of the device only needs to be able to accomplish the function, therefore as Vale teaches in Paragraph 0034 that the openings and the channel are capable of distributing saline, whenever there is no saline, they would be able to dissipate air through the openings during a procedure and as both Banko and Hancock teaches that the at least one thermal mitigation channel extends to the distal end (see annotated Fig. 2 of Banko; Hancock, Page 26, Lines 16- 34) and therefore is able to dissipate the heated air throughout the device.
Conclusion
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/L.R.R./Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771