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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. It is noted that no English language translation has been provided to date.
Formal Matters
Claims 1-14 are pending and under examination.
Specification - Objection
The abstract of the disclosure is objected to because it exceeds 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al., WO 2022177366 (25 August 2022) (the English language equivalent of which is US 20230389979) in view of Suh et al., US 20200000318 (2 January 2020).
Regarding claim 1, Lee teaches a surgical instrument (FIG 2, electric cauterization instrument 10) comprising:
an end tool (100, ¶244) including a first jaw (101, ¶264) and a second jaw (102, ¶264) that are rotatable (¶8);
a manipulation part (200, ¶225) including an actuation manipulation part (203, ¶225) configured to control actuation motions of the first jaw and the second jaw (¶397),
the manipulation part being configured to control motions of the end tool (¶235);
a power transmission part (FIG 2, 300, ¶246) comprising:
a first jaw wire (301/305; ¶248) connected to the manipulation part (200) to transfer a rotation of the manipulation part to the first jaw (¶241); and
a second jaw wire (302/306; ¶248) connected to the manipulation part to transfer the rotation of the manipulation part to the second jaw (¶241);
wherein the actuation manipulation (203) part (203) comprises: an actuation pulley (210/220, ¶404) rotatable around an actuation rotation shaft (¶401); and
a handle member (FIG 26, handle 204), that is fixedly coupled to the actuation pulley (FIG 26, 210/220), the handle member (204) being rotatable along with the actuation pulley (¶448).
Lee does not expressly teach the surgical instrument comprising a tensioner configured to rotate along with the rotation of the actuation pulley wherein the tensioner is configured to come into contact with the first jaw wire or the second jaw wire according to the rotation of the actuation pulley to apply additional tension to the first jaw wire or the second jaw wire.
Shu teaches cable actuation mechanisms for steerable medical devices (Abstract) comprising a tensioner (FIG 2C) configured to rotate along with the rotation of the actuation pulley (¶9) wherein the tensioner is configured to come into contact with the first jaw wire or the second jaw wire according to the rotation of the actuation pulley to apply additional tension to the first jaw wire or the second jaw wire (¶9).
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 Lee and Suh, given that the prior art included each element claimed, although not necessarily in a single reference. Lee and Suh teach in the same field of endeavor, cable actuation mechanisms for steerable medical devices.
Although, Lee discloses the claimed base steerable jawed surgical instrument, Lee does not teach tensioners or pre-tensioners on the cables. Suh specifically addresses the tensioning issue by teaching different types of tensioning and/or pre-tensioning mechanisms where the tensioning mechanisms are coupled to the actuation pulley (FIG 2C). Because Lee teaches a complex pulley system capable of steering and rotating the end effectors in multiple directions, a person of ordinary skill in the art, seeking to control tension on the pulley (e.g. cable tension) in Lee’s architecture would reasonably consult Suh’s cable tensioning solution. Suh’s tensioning system can be incorporated alongside Lee’s surgical device and steering system in coordination with the existing pulley structure using known assembly methods without redesigning Lee’s core device architecture. Because the references address the same engineering problem (the need for reliability steerability in cable/wire/pulley surgical instrumentation systems and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding coupled tensioning system and/or pre-tensioning system to the existing actuation mechanisms), 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.
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FIG 2C of Suh (¶9).
Regarding claim 2, Lee modified by Suh teaches the surgical instrument of claim 1, as set forth above.
Suh teaches wherein the tensioner is fixedly coupled to the actuation pulley (FIG 2C, ¶9).
Regarding claim 3, Lee modified by Suh teaches the surgical instrument of claim 1, as set forth above.
Suh teaches wherein the tensioner and the actuation pulley are integrally formed, and the actuation pulley is a non-circular pulley (FIG 2C, ¶9).
Regarding claim 4, Lee modified by Suh teaches the surgical instrument of claim 1, as set forth above.
Suh does not expressly teach wherein the tensioner is disposed on the handle member. However, Suh teaches that being able to adjust the tension of wire cables in or near cable driving parts (¶¶103, 105). In Suh’s device architecture, the actuation mechanism is where the driving parts are found and where the tension on the cables may be adjusted (claim 20). Given that Lee teaches the base device architecture manipulation part (200) including an actuation manipulation part (203) in the handle (204) where the actuation pulley (210/220) is located (FIG 26) it would be simple to follow Suh’s placement guidance to configure Suh’s tensioners in Lee’s handle, the component structure FIG 26 of Lee is already braced similarly to FIG 2C of Suh such that the tensioning mechanisms can be placed in the Suh-recommended location of the handle (204) of Lee without undue experimentation or unnecessary disruption of the flow of cables in Lee’s base device.
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Regarding claim 5, Lee modified by Suh teaches the surgical instrument of claim 1, as set forth above.
Lee teaches wherein the end tool (100) further includes an end tool jaw pulley (pulley 111, pulley 121; ¶282) that is coupled to the first jaw (101) or the second jaw (102),
the end tool jaw pulley (111/121; ¶282) being rotatable around a jaw rotation shaft (rotation shaft 141),
wherein the end tool jaw pulley (111/121) and the actuation pulley are connected to each other (¶284) via at least one jaw wire of the first jaw wire (301/305; ¶293) and the second jaw wire (302; ¶298),
wherein the end tool jaw pulley (FIGs 5, 6; 111/121) has a diameter that is less than (¶320, scaled comparison at FIG 26) a diameter of the actuation pulley (FIGs 25, 26; 210/220), and
wherein, when the at least one jaw wire moves, a rotation angle of the end tool jaw pulley is greater than a rotation angle of the actuation pulley (FIG 14, ¶298) .
Regarding claim 6, Lee modified by Suh teaches the surgical instrument of claim 5, as set forth above.
Lee teaches wherein the rotation angle (¶¶298-302) of the end tool jaw pulley (111/112) according to the rotation of the actuation pulley (FIGs 25, 26; 210/220) in a state in which the tensioner comes into contact with the first jaw wire (301/305; ¶248) or the second jaw wire (302/306; ¶248) is defined as a first rotation angle (up to the right angle, ¶299) (¶302),
wherein the rotation angle (¶¶298-302) of the end tool jaw pulley according to the rotation of the actuation pulley (FIGs 25, 26; 210/220) in a state in which the tensioner (Lee, FIG 26; Suh FIG 2C) is spaced apart from the first jaw wire (FIG 28; 301/305; ¶248) or the second jaw wire (FIG 27; 302/306; ¶248) is defined as a second rotation angle (expanding a rotation angle, ¶¶298-299), and wherein the first rotation angle (up to the right angle, ¶298), is greater than the second rotation angle (FIG 14; expanding a rotation angle, ¶¶298-299).
Given that Lee teaches the base device architecture manipulation part (200) including an actuation manipulation part (203) in the handle (204) where the actuation pulley (210/220) is located (FIG 26) it would be simple to follow Suh’s placement guidance to configure Suh’s tensioners in Lee’s device to provide the maximum controllability for tensioning given the determined rotation ranges and expanded rotation ranges for Lee’s base device so as not to stress any of the components by over or under tensioning them. The component structure FIG 26 of Lee is already braced similarly to FIG 2C of Suh such that the tensioning mechanisms can be placed in locations that are best suited to providing the optimal tensioning control on the base device of Lee. Tensioning in surgical instrumentation is old, well-known and routine in the surgical device arts and can be accomplished without undue experimentation.
Regarding claim 7, Lee modified by Suh teaches the surgical instrument of claim 1, as set forth above,
wherein the actuation manipulation part (203, ¶225) comprises:
a first actuation manipulation part (251, ¶416) including:
a first actuation pulley (210) rotatable around a first actuation rotation shaft (241); and
a first handle member (FIG 26, 204; ¶415) fixedly coupled to the first actuation pulley (210) and rotatable along with the first actuation pulley (¶416); and
a second actuation manipulation part (256, ¶416) including:
a second actuation pulley (220) rotatable around a second actuation rotation shaft (242); and
a second handle member (FIG 26, 252/257; ¶416) fixedly coupled to the second actuation pulley (220) and rotatable along with the second actuation pulley (220) (¶416).
Regarding claim 8, Lee modified by Suh teaches the surgical instrument of claim 7, as set forth above.
Lee teaches wherein the end tool (100) is in a closed state when the first jaw and the second jaw are in contact with each other (FIG 75, ¶181) and in an open state when the first jaw and the second jaw are spaced apart from each other (FIG 76, ¶182),
wherein the actuation manipulation part (203) is configured to form an input angle (¶417) defined as an angle relationship between the first handle member (FIG 26, 204; ¶415) and the second handle member (FIG 26, 252/257; ¶416),
wherein, when the actuation manipulation part (203) has the input angle (¶417) greater than or equal to a first predetermined angle (FIG 26), the end tool is configured to be in the open state (¶442), and wherein, when the actuation manipulation part has the input angle (¶417) less than the first predetermined angle (FIG 26), a pressure between the first jaw (101) and the second jaw (102) is changed (¶442).
Regarding claim 9, Lee modified by Suh teaches the surgical instrument of claim 8, as set forth above.
Lee teaches wherein, when the actuation manipulation part (203) has the input angle (¶417) greater than the first predetermined angle (FIG 26), the tensioner (Lee, FIG 26; Suh FIG 2C) is configured to be spaced apart from the first jaw wire (FIG 28; 301/305; ¶248) or the second jaw wire (FIG 27; 302/306; ¶248) and wherein, when the actuation manipulation part (203) has the input angle (¶417) less than the first predetermined angle (FIG 26), the tensioner is configured to contact the first jaw wire (301/305; ¶293) or the second jaw wire (302; ¶298).
Given that Lee teaches the base device architecture manipulation part (200) including an actuation manipulation part (203) in the handle (204) where the actuation pulley (210/220) is located (FIG 26) it would be simple to follow Suh’s placement guidance to configure Suh’s tensioners in Lee’s device to provide the maximum controllability for tensioning given the determined rotation ranges and expanded rotation ranges for Lee’s base device so as not to stress any of the components by over or under tensioning them. The component structure FIG 26 of Lee is already braced similarly to FIG 2C of Suh such that the tensioning mechanisms can be placed in locations that are best suited to providing the optimal tensioning control on the base device of Lee. Tensioning in surgical instrumentation is old, well-known and routine in the surgical device arts and can be accomplished without undue experimentation.
Regarding claim 10, Lee modified by Suh teaches the surgical instrument of claim 8, as set forth above.
Lee teaches wherein, when the actuation manipulation part (203) has the input angle (¶417) that is greater than or equal to the first predetermined angle (FIG 26), at least one of the first jaw wire (301/305; ¶293) and the second jaw wire (302; ¶298) is configured to remain in an elastically original state (¶¶315, 316), and
wherein, when the actuation manipulation part (203) has the input angle (¶417) that is less than the first predetermined angle (FIG 26), at least one of the first jaw wire (301/305; ¶293) and the second jaw wire (302; ¶298) is elastically deformed (¶¶315, 316).
Regarding claim 11, Lee modified by Suh teaches the surgical instrument of claim 10, as set forth above.
Lee teaches wherein, when the actuation manipulation part (203) has the input angle (¶417) less than the first predetermined angle (FIG 26), the input angle(¶417) is greater than or equal to a second predetermined angle (FIG 26) to prevent plastic deformation (¶¶315, 316) of at least one of the first jaw wire (301/305; ¶293) and the second jaw wire (302; ¶298) (¶¶315, 316).
Regarding claim 12, Lee modified by Suh teaches the surgical instrument of claim 11, as set forth above.
Lee teaches wherein the first handle member (FIG 26, 204; ¶415) and the second handle member (FIG 26, 252/257; ¶416) are configured to contact each other to form the second predetermined angle (FIG 26).
Regarding claim 13, Lee modified by Suh teaches the surgical instrument of claim 8, as set forth above.
Lee teaches wherein a force applied to the first jaw wire (301/305; ¶293) and the second jaw wire (302; ¶298) when the actuation manipulation part (203) has the input angle (¶417) less than the first predetermined angle (FIG 26), is greater than a force applied to the first jaw wire (301/305; ¶293) and the second jaw wire (302; ¶298) when the actuation manipulation part has the input angle (¶417) greater than the first predetermined angle (FIG 26) (¶441).
Regarding claim 14, Lee modified by Suh teaches the surgical instrument of claim 8, as set forth above,
wherein the end tool (100) is further configured to have a grip state (¶265) in which a first contact surface (FIG 4, 151, ¶346) of the first jaw first jaw (101, ¶264) and a second contact surface (FIG 4, 152, ¶346) of the second jaw second jaw (102, ¶264) are in contact with an external object (FIGs 18-21),
wherein, when the actuation manipulation part (203) has the input angle (¶417) that is greater than or equal to a third angle, the end tool (100) is in the released grip state (¶¶299, 301), and
an angle between the first contact surface and the second contact surface is changed due to a rotation (¶¶298, 299) of at least one of the first handle member (FIG 26, 204; ¶415) and the second handle member (FIG 26, 252/257; ¶416), and
wherein, when the actuation manipulation part (203) has the input angle (¶417) less than the third angle, the end tool (100) is configured to maintain the grip state (¶265) and a pressure (FIGs 19, 21) between the first contact surface (FIG 4, 151, ¶346) and the second contact surface (FIG 4, 152, ¶346) and the external object is changed (FIGs 20, 22) due to a user input (¶464) causing a rotation of at least one of the first handle member (FIG 26, 204; ¶415) and the second handle member (FIG 26, 252/257; ¶416).
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lee et al., US 20220218377 (14 July 2022) teaches a surgical instrument.
Lee et al., US 11,504,145 (22 November 2022) teaches a surgical instrument.
Lee et al., US 12,016,586 (25 June 2025) teaches a surgical instrument.
Wakana, WO 2021049286 A1 (18 March 2021) teaches surgical instrument, surgery assistance system, and operating unit for surgery.
Felder et al., US 20180206904 (26 July 2018) teach articulating electrosurgical tools.
Sano et al., JP 2014159071 A (4 September 2019) teaches a medical manipulator.
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-9pm CST) and R-F (9am-3pm CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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