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 .
Formal Matters
Applicant’s Response and Amendments filed 26 November 2025 is acknowledged and entered. Claim 1 is currently Amended. New claims 13-16 are added. Claims 1-16 are pending and under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 26 September 2025 and 14 April 2026 have been considered by the examiner. Signed copies are attached.
Response to Arguments
Applicant argues that the amendment to claim 1 (Remarks, numbered p. 6). Applicant argues that neither Kim nor Choi teach the amendments to claim 1. (Remarks, numbered pp. 7-8). Applicant argues that neither of the reference disclose any motivation for deriving the amendments to claim 1 (Remarks, numbered p. 9). Applicant argues that Stahler does not remedy the deficiencies in Kim and Choi (Remarks, numbered p. 10). Applicant argues that the tilting structure taught by Falb is raised merely to facilitate installation of the guide catheter and the Y-connector (¶51 of Falb) (Remarks, numbered pp. 10-11). Applicant argues that control of the guide catheter of Falb would not be possible when the Y-connector enclosure is in the tilted (raised) position (Remarks, numbered p. 11). Applicant argues that new claim 13-16 require that the direction for placing the surgical tool in the surgical tool assembly be different from a direction for placing the surgical tool in the surgical tool control assembly.
Applicant’s arguments have been fully considered, but they are not persuasive. Regarding the teachings of Kim and Choi, the references are not required for disclosing motivation to amendments to claim 1 where the amendments were not previous cited in claim 1. Insofar as part of the amendment to claim 1 “wherein the guide catheter assembly is configured to be tilted with respect to the main housing” is taught by Falb, as explained in response to the limitations of claim 12, in the Office Action mailed 23 September 2015, the motivations to combine are found in Falb.
However, the amendment to claim 1 “wherein the guide catheter control assembly is configured to be driven while being fitted with respect to the main housing” was not previously considered. Similarly, the recitations of new claims 13-16 have not previously been considered. Accordingly, new and modified rejections are set forth below.
Claim Rejections Withdrawn
The rejection of claims 1-5, 7, 10, and 11 under 35 U.S.C. 103 as being unpatentable over Kim et al., US 20200197111 (25 June 2020) in view of Choi et al., US 20210052339 (25 February 2021), is withdrawn in light of Applicant’s amendments. However, Applicant is advised that the rejections may be reinstated if the claims are further amended.
The rejection of claims 6, 8, and 9 under 35 U.S.C. 103 as being unpatentable over Kim et al., US 20200197111 (25 June 2020) in view of Choi et al., US 20210052339 (25 February 2021) and further in view of Stahler et al., US 20120071895 (22 March 2012), is withdrawn in light of Applicant’s amendments. However, Applicant is advised that the rejections may be reinstated if the claims are further amended.
The rejection of claim 12 under 35 U.S.C. 103 as being unpatentable over Kim et al., US 20200197111 (25 June 2020) in view of Choi et al., US 20210052339 (25 February 2021) and further in view of Falb et al., US 20210228841 (29 July 2021), is withdrawn in light of Applicant’s amendments. However, Applicant is advised that the rejections may be reinstated if the claims are further amended.
New Claim Rejections – Necessitated by Amendment and Necessitated by IDS
Claim Rejections - 35 USC § 112(a) – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The Specification does not disclose the portion of the amendment to claim 1, lines 17-18, “wherein the guide catheter control assembly is configured to be driven while being fitted with respect to the main housing”. This recitation at ¶107 is limited to the additional limitations at claim 1, lines 15 and 16. There is no textual or figurative support in the originally filed disclosure to support “wherein the guide catheter control assembly is configured to be driven while being fitted with respect to the main housing.”
The specification at 16 (¶93 of the publication) states that FIG 12 illustrates “the housing tilting portion 5 may tilt the main housing 1 with respect to a position where the surgical tool control apparatus 100 is installed (e.g. a robot arm)”. However, the surgical tool control apparatus is not the same structure as the guide catheter control assembly as recited in claim 1. The specification at 3 (¶19 of the publication) states that “[t]he surgical tool control apparatus may further include a connecting arm configured to connect the guide catheter control assembly to the main housing, and the guide catheter control assembly may be able to be tilted or translate with respect to the main housing through the connecting arm.” However, noting in the disclosure comports with “wherein the guide catheter control assembly is configured to be driven while being fitted with respect to the main housing.”
The examiner recognizes that mere rephrasing of a passage does not constitute new matter (MPEP 2163.07 and 608.01(o)). The examiner has given Applicant consideration for being their own lexicographer in the amended and newly added claims. However, there must still be originally filed support even if alternative comparable language (synonyms) are used.
Claims 13-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The disclosure states that “the surgical tool control assembly is installed in the main housing and configured to control at least one surgical tool. The guide catheter control assembly is positioned on a front end side of the main housing and configured to control a guide catheter that guides a path of the at least one surgical tool.” (publication, ¶8).
There are 22 occurrences of the phrase “guide catheter control assembly” in the disclosure. The disclosure at p. 19 of 25 (¶106 of the publication) states “the guide catheter control assembly 3 may control a guide catheter. The guide catheter may be disposed on a front end of the surgical tool control apparatus 100 to guide a path of at least one surgical tool T. The guide catheter control assembly 3 may grip or release the guide catheter. The guide catheter control assembly 3 may move the gripped guide catheter in the longitudinal direction or rotate the gripped guide catheter.” The disclosure at p. 19 bridging to p. 20 (¶107 of the publication) states that “[t]he guide catheter control assembly 3 may be able to tilt and/or translate with respect to the main housing 1 through the connecting arm 4. That is, the guide catheter control assembly 3 may adjust a position by the connecting arm 4.” The disclosure at p. 20 (¶108 of the publication) states “[t]he guide catheter control assembly 3 may control the guide catheter by substantially the same method as a surgical tool control assembly (e.g., the surgical tool control assembly 2 of FIG. 6)”.
There are 16 occurrences of the phrase “surgical tool control assembly”. FIG 4 is disclosed as illustrating the process in which a roller module of a surgical tool control assembly moves a surgical tool forward and backward according to an embodiment (¶¶49-50 of the publication). FIG 5 is disclosed as illustrating a process in which a roller module of a surgical tool control assembly rotates a surgical tool according to an embodiment (¶¶49-50 of the publication). The surgical tool control “apparatus” is taught at ¶51 of the publication, as independently controlling four surgical tools Ta, Tb, Tc, and Td through five roller modules.
However, there is no originally filed disclosure of the limitations in claim 13, lines 13-15, “wherein a direction for placing the guide catheter in the guide catheter control assembly is different from a direction for placing the at least one surgical tool in the surgical tool control assembly.”
The Specification teaches longitudinal directions, horizonal directions, vertical directions, tilt, translation, rotate, backward, and forward directions. However, there is no directionality disclosed “wherein a direction for placing the guide catheter in the guide catheter control assembly is different from a direction for placing the at least one surgical tool in the surgical tool control assembly.” Accordingly, roller modules of a surgical tool control assembly are taught as being able to move a surgical tool forward and backwards and rotating it. But in claim 13, lines 13-15, the limitation recites “wherein a direction for placing the guide catheter in the guide catheter control assembly is different from a direction for placing the at least one surgical tool in the surgical tool control assembly.” There is nothing in the disclosure about a direction for placing at least one surgical tool in the surgical tool control assembly or for a direction for placing the guide catheter in the guide catheter control assembly.
The examiner recognizes that mere rephrasing of a passage does not constitute new matter (MPEP 2163.07 and 608.01(o)). The examiner has given Applicant consideration for being their own lexicographer in the amended and newly added claims. However, there must still be originally filed support even if alternative comparable language (synonyms) are used.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 has been amended to recite “wherein the guide catheter control assembly is configured to be driven while being fitted with respect to the main housing”. This phrase is unclear and confusing. What is to be fitted and where? The surgical tool control “apparatus” is taught at ¶51 of the publication, as independently controlling four surgical tools Ta, Tb, Tc, and Td through five roller modules. It is unclear and confusing which one of the guide catheter control assembly components is supposed to be “fitted” and with what? There is no recitation of the term “fitted” in the disclosure.
Additionally, it is unclear and confusing how “with respect to the main housing” is to be interpreted. The specification states that a guide catheter control assembly is position on the front side of the main housing and may include a frame positioned on the front end of the main housing (p. 2; publication ¶8). A first roller module and a second roller module are installed in the frame and the second roller module may be horizontally moveable toward the first roller module so that the guide catheter is gripped between the first roller module and the second roller module” (p. 2; publication ¶8). The specification at 16 (¶93 of the publication) states that FIG 12 illustrates “the housing tilting portion 5 may tilt the main housing 1 with respect to a position where the surgical tool control apparatus 100 is installed (e.g. a robot arm)”. However, the surgical tool control apparatus is not the same structure as the guide catheter control assembly as recited in claim 1.
Claims 2-12 are rejected as depending from a rejected claim.
Applicant is referred to Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (2008). A five member expanded panel of the Board held that "if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 USC 112, second paragraph, as indefinite."
Applicant is also referred to Nautilus Inc., v. Biosig Instruments, Inc., 572 U.S. 898, 908-909 (2014) in which the Court held that a claim is indefinite if the specification and prosecution history fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention. The Court also held that a patent must be precise enough to afford clear notice of what is claimed thereby "appris[ing] the public of what is still open to them (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 373 (1996)), in a manner that avoids "[a] zone of uncertainty which enterprise and experimentation may enter only at the risk of infringement claims," (citing United Carbon Co., v. Binney & Smith Co., 317 U.S. 228, 236 (1942)) (Nautilus 909).
New claims 13-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The disclosure states that “the surgical tool control assembly is installed in the main housing and configured to control at least one surgical tool. The guide catheter control assembly is positioned on a front end side of the main housing and configured to control a guide catheter that guides a path of the at least one surgical tool.” (publication, ¶8).
There are 22 occurrences of the phrase “guide catheter control assembly” in the disclosure. The disclosure at p. 19 of 25 (¶106 of the publication) states “the guide catheter control assembly 3 may control a guide catheter. The guide catheter may be disposed on a front end of the surgical tool control apparatus 100 to guide a path of at least one surgical tool T. The guide catheter control assembly 3 may grip or release the guide catheter. The guide catheter control assembly 3 may move the gripped guide catheter in the longitudinal direction or rotate the gripped guide catheter.” The disclosure at p. 19 bridging to p. 20 (¶107 of the publication) states that “[t]he guide catheter control assembly 3 may be able to tilt and/or translate with respect to the main housing 1 through the connecting arm 4. That is, the guide catheter control assembly 3 may adjust a position by the connecting arm 4.” The disclosure at p. 20 (¶108 of the publication) states “[t]he guide catheter control assembly 3 may control the guide catheter by substantially the same method as a surgical tool control assembly (e.g., the surgical tool control assembly 2 of FIG. 6)”.
However, the recitations of “a direction” in claim 13, lines 13-15 are unclear and confusing. In the specification, FIG 4 is disclosed as illustrating the process in which a roller module of a surgical tool control assembly moves a surgical tool forward and backward according to an embodiment (¶¶49-50 of the publication). Similarly, FIG 5 is disclosed as illustrating a process in which a roller module of a surgical tool control assembly rotates a surgical tool according to an embodiment (¶¶49-50 of the publication). The surgical tool control “apparatus” is taught at ¶51 of the publication, as independently controlling four surgical tools Ta, Tb, Tc, and Td through five roller modules. Accordingly, the five roller modules of a surgical tool control assembly are taught as being able to move a surgical tool directionally, forward and backwards and rotating it.
However, in claim 13, lines 13-15, the limitation recites “wherein a direction for placing the guide catheter in the guide catheter control assembly is different from a direction for placing the at least one surgical tool in the surgical tool control assembly.” The specification teaches that rollers, roller plates, lead screw nuts, motors, and pulleys may engage in longitudinal directions, horizonal directions, vertical directions, tilt, translation, rotation, backward, and forward directions. However, it is unclear and confusing which component parts (e.g. rollers, roller plates, lead screw nuts, motors, and pulleys) claim 13 is referring to for “the guide catheter control assembly” and the “surgical tool control assembly”. Additionally, “the direction for placing” in claim 13 is unclear and confusing given that “at least four” multiple tools can be used (Ta, Tb, Tc, Td) in the five rollers, just for the surgical tool control assembly.
Claims 14-16 are rejected as depending from a rejected claim.
Applicant is referred to Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (2008). A five member expanded panel of the Board held that "if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 USC 112, second paragraph, as indefinite."
Applicant is also referred to Nautilus Inc., v. Biosig Instruments, Inc., 572 U.S. 898, 908-909 (2014) in which the Court held that a claim is indefinite if the specification and prosecution history fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention. The Court also held that a patent must be precise enough to afford clear notice of what is claimed thereby "appris[ing] the public of what is still open to them (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 373 (1996)), in a manner that avoids "[a] zone of uncertainty which enterprise and experimentation may enter only at the risk of infringement claims," (citing United Carbon Co., v. Binney & Smith Co., 317 U.S. 228, 236 (1942)) (Nautilus 909).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 7, 10, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al., US 20200197111 (25 June 2020) in view of Choi et al., US 20210052339 (25 February 2021) and further in view of Falb et al., US 20210228841 (29 July 2021) (all previously cited of record) and Liu et al., CN 111529065 (14 August 2020) (cited on Applicant’s IDS 4/14/2026).
Regarding claim 1, Kim teaches a surgical tool control apparatus comprising:
a main housing (FIG 1, guide tray 12);
a surgical tool control assembly (FIG 1, guidewire driver 64) installed in the main housing (FIG 1, guide tray 12) and configured to control at least one surgical tool (FIG 1, guide wire 54) ; and
a guide catheter control assembly (FIG 1, sheath driver 62) positioned on a front end side of the main housing (FIG 1, base 60), and configured to control a guide catheter that guides a path of the at least one surgical tool (claim 1),
wherein the guide catheter control assembly (¶24, robotic controller 50 includes a sheath driver 62, and a guidewire driver 64) comprises:
a frame positioned on a front end of the main housing (¶25 “base 61 fixedly supported on the end of a flange plate 66 extending generally perpendicular to the mounting base 60, and here the base 61 forms a roller housing having two pairs of pinch roller assemblies 68a, 68b (FIGS. 3A, 3B)”; and
a first roller module and a second roller module (¶25, pinch roller 68a, 68b) installed in the frame.
Kim does not teach wherein the second roller module is configured to be horizontally movable toward the first roller module so that the guide catheter is gripped between the first roller module and the second roller module.
Kim does not teach wherein the guide catheter assembly is configured to be tilted with respect to the main housing, and wherein the guide catheter assembly is configured to be driven while being fitted with respect to the main housing.
However, Kim does teach a connecting arm configured to connect the guide catheter control assembly to the main housing (Fig 3A; ¶26, mounting base 60).
Choi teaches a medical robot (FIG 1, medical robot 1) comprising a guide catheter (FIG 2, guide catheter 61), a catheter control assembly (FIG 1, first driving device 10) includes a first roller module (first roller module 100) and a second roller module (second roller module 200) (FIG 7; ¶77). Choi teaches wherein the second roller module is configured to be horizontally movable toward the first roller module so that the guide catheter is gripped between the first roller module and the second roller module (¶79, “[t]he “clamping operation mode” of the first driving device 10 may be achieved by bringing the roller unit 110 of the first roller module 100 and the second roller unit 210 of the second roller module 200 closer to each other or moving away from each other”).
Falb teaches wherein the guide catheter assembly comprising a flexible track. Falb teaches wherein the guide catheter control assembly is configured to be tilted or translate with respect to the main housing through the connecting arm (FIG 3; ¶51).
Liu teaches a lifting drive assembly (FIG 4, lifting drive assembly 321; IDS submission FOR reference 4/14/2026, p. 19 of 24, Description of Reference Signs) where the “lifting and rotating of the main roller can be realized by the cooperation of the lifting driving component and the rotary driving component in the main finger component, and the rotary pushing or rotating backward of the component to be inserted is realized” (IDS submission FOR reference 4/14/2026, p. 20 of 24, fourth full paragraph). Although Liu is a machine translation, this section is interpreted to mean that the guide catheter control assembly is configured to be driven while being fitted with respect to the main housing.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Kim, Choi, Falb, and Liu, given that the prior art included each element claimed, although not necessarily in a single reference.
Kim, Choi, Falb, and Liu teach in the same field of endeavor, that of guide catheter devices utilizing robotic systems. The prior art of Kim, Choi, Falb, and Lui contained a device which differed from the claimed invention by the substitution of some components with other components. Although Kim discloses the claimed base surgical tool control apparatus (main housing, guide tray, guidewire driver, guidewire, sheath driver (guide catheter control assembly), robotic controller, guidewire driver, rollers, and frames, Kim does not disclose wherein the second roller module is configured to be horizontally movable toward the first roller module so that the guide catheter is gripped between the first roller module and the second roller module. Kim does not teach wherein the guide catheter assembly is configured to be tilted with respect to the main housing, and wherein the guide catheter assembly is configured to be driven while being fitted with respect to the main housing. Kim does not teach wherein the guide catheter assembly is configured to be tilted with respect to the main housing. Kim does not teach wherein the guide catheter control assembly is configured to be driven while being fitted with respect to the main housing.
However, Kim does teach a connecting arm configured to connect the guide catheter control assembly to the main housing (Fig 3A; ¶26, mounting base 60).
Choi specifically addresses a medical robot (FIG 1, medical robot 1) comprising a guide catheter (FIG 2, guide catheter 61), a catheter control assembly (FIG 1, first driving device 10) includes a first roller module (first roller module 100) and a second roller module (second roller module 200) (FIG 7; ¶77). Choi teaches wherein the second roller module is configured to be horizontally movable toward the first roller module so that the guide catheter is gripped between the first roller module and the second roller module (¶79, “[t]he “clamping operation mode” of the first driving device 10 may be achieved by bringing the roller unit 110 of the first roller module 100 and the second roller unit 210 of the second roller module 200 closer to each other or moving away from each other”).
Falb specifically addresses a guide catheter control with a flexible track. Falb teaches wherein the guide catheter control assembly is configured to be tilted or translate with respect to the main housing through the connecting arm (FIG 3; ¶51).
Liu specifically addresses a lifting drive assembly (FIG 4, lifting drive assembly 321; IDS submission FOR reference 4/14/2026, p. 19 of 24, Description of Reference Signs) where the “lifting and rotating of the main roller can be realized by the cooperation of the lifting driving component and the rotary driving component in the main finger component, and the rotary pushing or rotating backward of the component to be inserted is realized” (IDS submission FOR reference 4/14/2026, p. 20 of 24, fourth full paragraph).
Because Kim teaches the base surgical tool control apparatus and a connecting arm configured to connect the guide catheter control assembly to the main housing (Fig 3A; ¶26, mounting base 60), a person of ordinary skill in the art, seeking more flexibility to control and guide the assembly when using a robotic arm would be motivated by the teachings of Falb to incorporate a flexible track wherein the guide catheter control assembly is configured to be tilted or translate with respect to the main housing through the connecting robotic arm. Choi and Liu each provide additional robotic control over the guide catheter control assembly within the robotic system. Choi’s enhanced guide catheter gripping roller solution is readily integrated with Kim’s base device and can be incorporated alongside using known assembly methods. Similarly, the flexible track and tilt/raise/lift mechanisms of Falb and Liu can be incorporated alongside Kim’s base model by utilizing Falb’s flexible track and Liu’s lifting drive assembly in order to provide more control of lifting and rotating the main roller as expressly motivated by Liu. These elements can be incorporated into the base module of Kim, modified by Choi, using known assembly methods without undue experimentation.
Because the references address the same engineering problem (robotic system based catheter guidewire tool control apparatus) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding or substituting gripping rollers, adding a tilt/lift/rise mechanism and a flexible track to the existing base device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
The phrase “front end side” is broadly interpreted (BRI) in light of the guidance in the Specification at p. 19 as “a proximal end portion side”.
Regarding claim 2, Kim modified by Choi, Falb, and Liu teaches the surgical tool control apparatus of claim 1, as set forth above.
Kim teaches wherein the first roller module and the second roller module each comprise: a roller plate connected to the frame (FIGs 3A, 3B,; ¶25 flange plate 66; and a roller member rotatably provided on the roller plate (FIGs 3A, 3B; ¶25 base 61 forms a roller housing having two pairs of pinch roller assemblies 68a, 68b).
The term “roller plate” is broadly interpreted (BRI) in light of the Specification at p. 2, such that the roller plate may before a function of connecting the roller module to the frame.
Regarding claim 3, Kim modified by Choi, Falb, and Liu teaches the surgical tool control apparatus of claim 2, as set forth above.
Choi teaches wherein, in a state in which the guide catheter is gripped, the gripped guide catheter is configured to be moved in a longitudinal direction by rotating the roller members of the first roller module and the second roller module (¶77 “roller unit 110 of the first roller module 100 and a roller unit 210 of the second roller module 200 may face away from each other. The roller unit 110 of the first roller module 100 and the second roller unit 210 of the second roller module 200 respectively have rotation axes parallel to each other, and rotation directions thereof may be opposite to each other”).
Regarding claim 4, Kim modified by Choi, Falb, and Liu teaches the surgical tool control apparatus of claim 2, as set forth above.
Choi teaches wherein, in a state in which the guide catheter is gripped, the gripped guide catheter is configured to be rotated by vertically moving the roller member of at least one of the first roller module or the second roller module (¶80 “[t]he “vertical operation mode” of the first driving device 10 may be achieved by moving the roller unit 110 of the first roller module 100 and the roller unit 210 of the second roller module 200 in opposite directions to each other in the vertical direction”).
Regarding claim 5, Kim modified by Choi, Falb, and Liu teaches the controller module control apparatus of claim 4, as set forth above.
Choi teaches wherein the roller plate comprises an upper roller plate (FIG 5A, roller module 100; FIG 5B, roller module 200) which is connected to the frame (FIG 7, based module 300), and a lower roller plate which is positioned on a lower side of the upper roller plate and to which the roller member is rotatably connected (FIG 5A, roller module 200; FIG 5B, roller module 100), and the first roller module or the second roller module further comprises a vertical movement portion configured to vertically move the lower roller plate with respect to the upper roller plate (FIG 6).
Regarding claim 7, Kim modified by Choi, Falb, and Liu teaches the surgical tool control apparatus of claim 3, as set forth above.
Choi teaches wherein the first roller module (first roller module 100) or the second roller module (second roller module 200) further comprises:
a rotation driving portion configured to rotate the roller member with respect to the roller plate (FIGs 11A-11C; ¶94, base module 300).
Regarding claim 10, Kim modified by Choi, Falb, and Liu teaches the surgical tool control apparatus of claim 2, as set forth above.
Choi teaches wherein the guide catheter control assembly further comprises: a horizontal movement portion configured to horizontally move the second roller module (FIGs 11A-C; ¶¶47, 79, 93, 95).
Regarding claim 11, Kim modified by Choi, Falb, and Liu teaches the surgical tool control apparatus of claim 10, as set forth above, wherein the horizontal movement portion comprises:
Choi teaches a horizontal movement driving motor (FIGs 11A-C; ¶¶47, 79, 93, 95, first driving motor 320 of based module 300); a horizontal movement lead screw (¶¶95-96, lead screw 330) configured to be connected to the frame in a horizontal direction and receive rotational power from the horizontal movement driving motor (FIGs 11A-C; ¶¶95-96, first driving motor 320 of based module 300) and
a horizontal movement lead screw nut (¶96, first nut 340 and second nut 350) that is configured to be engaged with the horizontal movement lead screw (¶96) and has one side connected to the roller plate to horizontally move the roller plate in accordance with rotation of the horizontal movement lead screw (¶94).
Claims 6, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al., US 20200197111 (25 June 2020) in view of Choi et al., US 20210052339 (25 February 2021), Falb et al., US 20210228841 (29 July 2021) (all previously cited of record) and Liu et al., CN 111529065 (14 August 2020) (cited on Applicant’s IDS 4/14/2026), and further in view of Stahler et al., US 20120071895 (22 March 2012) (previously cited of record).
Regarding claim 6, Kim modified by Choi, Falb, and Liu teaches the surgical tool control apparatus of claim 5, as set forth above, for the reasons set forth above.
Choi teaches wherein the vertical movement portion comprises: a vertical movement driving motor (¶¶89-90, driving unit 120 including driving motor 122);
a vertical movement lead screw nut (¶¶100-102, 104, 105, lead screw nut 116) configured to integrally rotate (¶102); and
a vertical movement lead screw (¶¶100-102, 104, 105, lead screw 115) that is configured to be engaged with the vertical movement lead screw nut (¶¶100-102, 104, 105, lead screw nut 116) and has one side connected to the lower roller plate (¶96, base module 300) to vertically move the lower roller plate in accordance with rotation of the vertical movement lead screw nut.
Choi does not teach a vertical movement pulley configured to receive rotational power from the vertical movement driving motor.
Choi teaches a vertical movement lead screw nut that is configured to integrally rotate, as set forth above, but Choi does not teach that it is configured to integrally rotate with the vertical movement pulley.
Instead of teaching pulleys, Choi teaches that the motors operate to actuate bevel and spur gears rather than pulleys. Kim teaches idler pulleys at ¶28, but these do not rotate the rollers.
Stahler teaches FIG 79B where rotating the rollers “can be directly driven by a motor or driven indirectly by a series of gears, belts or pulleys (not shown)” (¶549).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Kim, Choi, Falb, Liu, and Stahler given that the prior art included each element claimed, although not necessarily in a single reference. Kim, Choi, Falb, Liu, and Stahler teach in the same field of endeavor, that of guide catheter devices utilizing robotic systems.
The prior art of Kim, Choi, Falb, Lui, and Stahler contained a device which differed from the claimed invention by the substitution of some components with other components. Specifically, Stahler teaches that the guide catheters can either be directly motor driven or indirectly motor driven via a series of gears, belts or pulleys.
As set forth in the rationale above, because Kim teaches the base surgical tool control apparatus and a connecting arm configured to connect the guide catheter control assembly to the main housing (Fig 3A; ¶26, mounting base 60), a person of ordinary skill in the art, seeking more flexibility to control and guide the assembly when using a robotic arm would be motivated by the teachings of Falb to incorporate a flexible track wherein the guide catheter control assembly is configured to be tilted or translate with respect to the main housing through the connecting robotic arm. Choi and Liu each provide additional robotic control over the guide catheter control assembly within the robotic system. Choi’s enhanced guide catheter gripping roller solution is readily integrated with Kim’s base device and can be incorporated alongside using known assembly methods. Similarly, the flexible track and tilt/raise/lift mechanisms of Falb and Liu can be incorporated alongside Kim’s base model by utilizing Falb’s flexible track and Liu’s lifting drive assembly in order to provide more control of lifting and rotating the main roller as expressly motivated by Liu. These elements can be incorporated into the base module of Kim, modified by Choi, using known assembly methods without undue experimentation.
Additionally, one of ordinary in the art before the effective filing date of the claimed invention could have substituted the gears of Choi and Kim with pulleys taught by Stahler as equivalent alternatives between gears, belts, and pulleys, substituting one known element for another, and the results of the substitution would have been predictable and would not have required undue experimentation.
Because the references address the same engineering problem (robotic system based catheter guidewire tool control apparatus) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding or substituting gripping rollers, adding a tilt/lift/rise mechanism and a flexible track to the existing base device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 8, Kim modified by Choi, Falb, and Liu teaches the surgical tool control apparatus of claim 7, as set forth above, for the reasons set forth above.
Choi teaches wherein the rotation driving portion comprises:
a rotation driving motor (¶¶94-95, driving motor 320 rotates screw 320 of base module 300).
Choi does not teach a rotation drive pulley configured to receive rotational power from the rotation driving motor; at spline nut configured to integrally rotate with the rotation drive pulley; and a spline shaft that is engaged with the spline nut and has one side connected to the roller member and configured to rotate the roller member in accordance with rotation of the spline nut.
Instead of teaching pulleys, Choi and Kim teach that the motors operate to actuate bevel and spur gears rather than pulleys.
Stahler teaches guide catheter systems. Stahler teaches FIG 79B where rotating the rollers “can be directly driven by a motor or driven indirectly by a series of gears, belts or pulleys (not shown)” (¶549). Stahler also teaches FIG 79B where “elongate member manipulator 1100 may include a right spline coupling gear 1134, a left spline coupling gear 1135, a right leadscrew coupling gear 1140 and a left leadscrew coupling gear 1141. To rotate the rollers 1104, 1124, the left spline gear stack 1110 is driven by a spline belt 1112, which in turn can be directly driven by a motor or driven indirectly by a series of gears, belts or pulleys (not shown)” (¶549). Stahler also teaches FIG 79C where “[t]he roller actuator 1170 includes a one or more spline actuators 1172 having a spline shaft 1174 coupled to a spline nut 1176 mounted on spline nut bearings 1178. The spline nut 1176 is rotated by a spline gear 1180 which can either be directly motor driven or indirectly motor driven via a series of gears, belts or pulleys (not shown)” (¶553).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Kim, Choi, Falb, Liu, and Stahler given that the prior art included each element claimed, although not necessarily in a single reference. Kim, Choi, Falb, Liu, and Stahler teach in the same field of endeavor, that of guide catheter devices utilizing robotic systems.
The prior art of Kim, Choi, Falb, Lui, and Stahler contained a device which differed from the claimed invention by the substitution of some components with other components. Specifically, Stahler teaches that the guide catheters can either be directly motor driven or indirectly motor driven via a series of gears, belts or pulleys.
As set forth in the rationale above, because Kim teaches the base surgical tool control apparatus and a connecting arm configured to connect the guide catheter control assembly to the main housing (Fig 3A; ¶26, mounting base 60), a person of ordinary skill in the art, seeking more flexibility to control and guide the assembly when using a robotic arm would be motivated by the teachings of Falb to incorporate a flexible track wherein the guide catheter control assembly is configured to be tilted or translate with respect to the main housing through the connecting robotic arm. Choi and Liu each provide additional robotic control over the guide catheter control assembly within the robotic system. Choi’s enhanced guide catheter gripping roller solution is readily integrated with Kim’s base device and can be incorporated alongside using known assembly methods. Similarly, the flexible track and tilt/raise/lift mechanisms of Falb and Liu can be incorporated alongside Kim’s base model by utilizing Falb’s flexible track and Liu’s lifting drive assembly in order to provide more control of lifting and rotating the main roller as expressly motivated by Liu. These elements can be incorporated into the base module of Kim, modified by Choi, using known assembly methods without undue experimentation.
Additionally, one of ordinary in the art before the effective filing date of the claimed invention could have substituted the gears of Choi and Kim with pulleys taught by Stahler as equivalent alternatives between gears, belts, and pulleys, substituting one known element for another, and the results of the substitution would have been predictable and would not have required undue experimentation.
Because the references address the same engineering problem (robotic system based catheter guidewire tool control apparatus) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding or substituting gripping rollers, adding a tilt/lift/rise mechanism and a flexible track to the existing base device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 9, Kim modified by Choi, Falb, Liu, and Stahler teaches the surgical tool control apparatus of claim 8, as set forth above, for the reasons set forth above.
Stahler teaches wherein the rotation driving portion further comprises: a shaft support configured to be positioned between the rotation drive pulley and the spline shaft to prevent wobble of the spline shaft (¶555).
Conclusion
No claim is allowed.
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 CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-6pm CST) and R-F (9am-3pm CST).
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/CHERIE M POLAND/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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