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 04/25/2025 have been entered. Claims 1-19, and 22 are pending in the application. Claims 1-11 remain withdrawn for being drawn to an unelected Group. The amendment of claim 19 overcomes the previous claim objection. As the language of claims 14 and 16 has been canceled from these claims but is present within newly amended claim 12, and the language in claim 12 has clarified the limitations that caused the previous 112(b) rejection, that rejection has been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13-17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 recites “wherein the attitude sensing assembly comprises an acceleration sensor, and the attitude data comprises acceleration data of the surgical apparatus”, since this limitation is already recited in claim 12, claim 13 fails to further limit the subject matter of claim 12. As claims 14- 17 depend on or from rejected claim 13, they are rejected as well. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12- 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tan et al. (CN 108348259) in view of Shelton, IV et al. (US 2019/0201136) as evidenced by Landau et al. (2009) Industrial Engineering and Ergonomics: Visions, Concepts, Methods, and Tools.
Regarding claim 12, Tan teaches a surgical apparatus (10)(Figs. 1-10D)(Paragraph 0002) comprising:
an adapter (handle 100)(Paragraph 0046) comprising:
a casing (housing/outer casing 110)(Paragraph 0055) comprising an opening provided at a distal end of the casing (see annotated Fig. 9 below);
a working component (body portion 111);
a handheld component (fixed handle portion 112),
a rotary head (rotary knob 190 and receiver assembly 170)(Paragraph 0055), sleeved onto the opening of the casing (see annotated Fig. 9 below) and configured to be rotatable relative to the casing (Paragraph 0057), the rotary head comprising a first through hole (see annotated Fig 3 below) and a first guide member (ball bearing 178, pin 180)(Paragraph 0053) disposed in the first through hole (see annotated Fig 3 below);
a shaft assembly (endoscope assembly 200), detachably connected to the adapter (Paragraph 0050) and which is configured to insert into the working component (see annotated Fig. 9 below) and comprising:
a firing sleeve (elongated shaft 220)(Paragraph 0048); and
a coupling component (proximal hub 210, longitudinally extending slot 212, annular groove 214)(Paragraph 0049), disposed at an end of the firing sleeve (see annotated Fig. 2 below), the coupling component being configured to insert into the opening of the casing after passing through the first through hole of the rotary head (Paragraph 0050), the coupling component comprising a coupling casing (proximal hub 210) and a second guide member (longitudinally extending slot 212, annular groove 214) disposed on the coupling casing (see annotated Fig. 2 below), wherein the first guide member (ball bearing 178, pin 180) and the second guide member (longitudinally extending slot 212, annular groove 214) are engaged with each other in a snap-fit manner to maintain both the rotary head and the shaft assembly in a locked position (In Paragraphs 0052 and 0053, Tan teaches that the ball bearing and the pin both fit into the annular groove and the longitudinally extending slot respectively, and then they exert force on the groove and slot in order to lock the rotary head and the shaft assembly. According to Landau et al. (Page 596), a snap-fit is “a form-locking fastening linking two components and using no other positioning feature than the intrinsic elasticity of the materials”. In this case, when the first component (ball bearing and pin) and the second component (slot and groove) are engaged with each other, they maintain both the rotary head and the shaft assembly in a locked position without any other positioning feature other than the intrinsic elasticity of the materials;
a clip jaw (360a)(Paragraph 0071 teaches that the endoscope assembly 300, of which the jaw member 360a is a part of, can be used with the handle assembly 100.).
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Tan does not teach wherein the handheld component is detachably connected to the working component, and wherein the surgical apparatus further comprises: a clip-cartridge assembly, located in the firing sleeve and configured to provide a ligating clip and to deliver the ligating clip, an attitude sensing assembly and a control assembly, electrically connected with the attitude sensing assembly; wherein the attitude sensing assembly is configured to acquire attitude data of the surgical apparatus and send the attitude data to the control assembly, the control assembly is configured to determine whether to activate an automatic clip-delivery mode based on the attitude data and determine whether the ligating clip is placed on the clip jaw, wherein the clip-cartridge assembly automatically delivers the ligating clip to the clip jaw, if it’s determined to activate the automatic clip- delivery mode and determined that the ligating clip is not placed on the clip jaw.
Regarding the handheld component is detachably connected to the working component, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the handheld component and the working component as taught by Tan to be detachably connected, as it making separable what was known to be formed from an integral part, which is an obvious engineering choice (see MPEP 2144.04 V).
Regarding an attitude sensing assembly and control assembly, Shelton, IV (Shelton, IV et al.) teaches a surgical apparatus (700)(Figs. 17- 19) with an end effector (702) and a shaft assembly (740). Shelton, IV further teaches an attitude sensing assembly (position sensor 734) and a control assembly (control circuit 710), electrically connected with the attitude sensing assembly (Paragraph 0615); wherein the attitude sensing assembly is configured to acquire attitude data of the surgical apparatus and send the attitude data to the control assembly (Paragraphs 0615- 0617), the control assembly is configured to determine whether to activate an automatic delivery mode based on the attitude data (Paragraph 0518 teaches that the control assembly (710) is programmed to control functions of the end effector based on data, and that it can be programmed to select a firing control program. Therefore, when it receives the data from the attitude sensing assembly, the control assembly can decide whether to fire or not.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the surgical apparatus as taught by Tan to include an attitude sensing assembly and a control assembly as taught by Shelton, IV, as it has been held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (MPEP 2144) and including these assemblies would make the surgical apparatus an automatic device.
Tan and Shelton, IV do not teach wherein the surgical apparatus further comprises: a clip-cartridge assembly, located in the firing sleeve and configured to provide a ligating clip and to deliver the ligating clip and wherein the control assembly is configured to determine whether the ligating clip is placed on the clip jaw, wherein the clip-cartridge assembly automatically delivers the ligating clip to the clip jaw, if it’s determined to activate the automatic clip- delivery mode and determined that the ligating clip is not placed on the clip jaw.
However, Shelton, IV teaches in a second embodiment, a similar surgical apparatus (clip applier 71600)(Figs. 77)(Paragraph 0446) comprising clip jaws (first jaw 71610a and 71610b), a ligating clip (71604)(Paragraph 0002), a clip-cartridge assembly (clip magazine 70650), a sensor circuit and a control assembly (Paragraph 0446) configured to determine the position of the clip in relation to the jaw (Paragraphs 0446- 0447)(As the control assembly determines the position, it would determine whether the clip is on the jaw.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the control system of the combination to be configured to determine the position of the clip in relation to the jaw as taught in the second embodiment of Shelton, IV, since this allows the system to locate the clip during a procedure (Paragraph 0446).
The combination does not teach wherein the clip-cartridge assembly automatically delivers the ligating clip to the clip jaw, if it’s determined to activate the automatic clip- delivery mode and determined that the ligating clip is not placed on the clip jaw.
However, Shelton, IV teaches in a third embodiment a surgical apparatus which has a clip applier and a control system that can automatically load a clip into the jaws of the clip applier when the system detects that the clip applier is in position (Paragraph 0464).
It would have been obvious to one of ordinary skill in the art to modify the control system of the combination to be able to automatically load a clip into the jaws of the clip applier as taught in the third embodiment of Shelton, IV, since Shelton, IV teaches that this arrangement “reduces the time needed to load the clip applier after being inserted into a patient” (Paragraph 0464).
Regarding the control system being configured to determine that the ligating clip is not placed on the clip jaw, as the combination has a control system that detects the position of the clip on the jaws, it would therefore be able to determine if a ligating clip is present on the jaws, and then load a clip when one is needed to perform an operation.
The combination does not teach wherein the attitude sensing assembly comprises an acceleration sensor, and the attitude data comprises acceleration data of the surgical apparatus.
However, Shelton, IV teaches that the control assembly 710 can be in contact with an accelerometer (sensor 738) that is placed on the end effector of the surgical apparatus (Paragraph 0628, 0630).
It would have been obvious to one of ordinary skill in the art to modify the attitude sensing assembly as taught by the combination to include an accelerometer as taught by Shelton, IV, as the accelerometer determines the acceleration of the surgical apparatus and aids in determining distance parameters (Paragraph 0628).
Regarding the attitude data comprising the acceleration data of the surgical apparatus, as the accelerometer is a part of the attitude assembly in the combination, the acceleration data from the accelerometer would be a part of the data.
Regarding wherein when a number of ligating clip having been delivered to the clip jaw is zero, the control assembly is further configured to determine to activate the automatic clip-delivery mode, if a variation amount of acceleration data within a first preset time period is matched with a first template variation rule and when a number of the ligating clip having been delivered to the clip jaw is greater than zero, the control assembly is further configured to determine to activate the automatic clip-delivery mode, if a variation amount of acceleration data within a second preset time period is not matched with a second template variation rule, as Shelton, IV teaches an accelerometer on the end effector and therefore the clip jaw, and the control assembly (710) of the combination is taught to comprise a microprocessor that can execute instructions, it would be obvious to one of ordinary skill in the art to configure the control assembly to accomplish these functions in accordance to the data received from the sensor. Furthermore, as this language is functional, the structure only needs to have the ability to complete the function, which the control assembly would be able to do as the microprocessor allows for the computation of data and the issuing of commands (Shelton, Paragraphs 0517 and 0518).
Regarding claims 14 and 15, Tan and Shelton, IV make obvious the apparatus as discussed above.
Regarding wherein the first template variation rule is established based on a variation amount of acceleration data in a starting process of a surgery operated by the surgical apparatus (claim 14) and wherein the first template variation rule is that, a variation amount of displacement, along a central axis of the shaft assembly and towards the clip jaw, within the first preset time period is greater than a first preset value (claim 15), as Shelton, IV teaches an accelerometer (sensor 738) on the end effector (Paragraphs 0628 and 0630), therefore the clip jaw, and as the control assembly (710) is taught to comprise a microprocessor that can execute instructions (Paragraph 0517), it would be obvious to configure the control assembly to accomplish these functions in accordance to the data that it receives from the sensor.
Regarding claims 16 and 17, Tan and Shelton, IV make obvious the apparatus as discussed above.
Regarding wherein the second template variation rule is established based on a variation amount of acceleration data in an ending process of a surgery operated by the surgical apparatus (claim 16) and wherein the second template variation rule is that, a variation amount of displacement, along a central axis of the shaft assembly and towards the handhold component, within the second preset time period is greater than a second preset value (claim 17), as Shelton, IV teaches an accelerometer (sensor 738) on the end effector (Paragraphs 0628 and 0630), therefore the clip jaw, and as the control assembly (710) is taught to comprise a microprocessor that can execute instructions (Paragraph 0517), it would be obvious to configure the control assembly to accomplish these functions in accordance to the data that it receives from the sensor.
Regarding claim 22, Tan teaches a clip- delivery method performed with a surgical apparatus (10)(Figs. 1-10D)(Paragraphs 0002 and 0079- 0083) comprising:
an adapter (handle 100)(Paragraph 0046) comprising:
a casing (housing/outer casing 110)(Paragraph 0055) comprising an opening provided at a distal end of the casing (see annotated Fig. 9 below);
a rotary head (rotary knob 190 and receiver assembly 170)(Paragraph 0055), sleeved onto the opening of the casing (see annotated Fig. 9 below) and configured to be rotatable relative to the casing (Paragraph 0057), the rotary head comprising a first through hole (see annotated Fig 3 below) and a first guide member (ball bearing 178, pin 180)(Paragraph 0053) disposed in the first through hole (see annotated Fig 3 below);
a shaft assembly (endoscope assembly 200), detachably connected to the adapter (Paragraph 0050) comprising:
a firing sleeve (elongated shaft 220)(Paragraph 0048); and
a coupling component (proximal hub 210, longitudinally extending slot 212, annular groove 214)(Paragraph 0049), disposed at an end of the firing sleeve (see annotated Fig. 2 below), the coupling component being configured to insert into the opening of the casing after passing through the first through hole of the rotary head (Paragraph 0050), the coupling component comprising a coupling casing (proximal hub 210) and a second guide member (longitudinally extending slot 212, annular groove 214) disposed on the coupling casing (see annotated Fig. 2 below), wherein the first guide member (ball bearing 178, pin 180) and the second guide member (longitudinally extending slot 212, annular groove 214) are engaged with each other in a snap-fit manner to maintain both the rotary head and the shaft assembly in a locked position (In Paragraphs 0052 and 0053, Tan teaches that the ball bearing and the pin both fit into the annular groove and the longitudinally extending slot respectively, and then they exert force on the groove and slot in order to lock the rotary head and the shaft assembly. According to Landau et al. (Page 596), a snap-fit is “a form-locking fastening linking two components and using no other positioning feature than the intrinsic elasticity of the materials”. In this case, when the first component (ball bearing and pin) and the second component (slot and groove) are engaged with each other, they maintain both the rotary head and the shaft assembly in a locked position without any other positioning feature other than the intrinsic elasticity of the materials;
wherein the adapter comprises:
a working component (body portion 111);
a handheld component (fixed handle portion 112),
the shaft assembly is configured to insert into the working component (see annotated Fig. 9 below) and the shaft assembly comprises:
a clip jaw (360a)(Paragraph 0071 teaches that the endoscope assembly 300, of which the jaw member 360a is a part of, can be used with the handle assembly 100.).
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Tan does not teach wherein the handheld component is detachably connected to the working component, and wherein the surgical apparatus further comprises: a clip-cartridge assembly, located in the firing sleeve and configured to provide a ligating clip and to deliver the ligating clip, an attitude sensing assembly and a control assembly, electrically connected with the attitude sensing assembly; wherein the attitude sensing assembly is configured to acquire attitude data of the surgical apparatus and send the attitude data to the control assembly, the control assembly is configured to determine whether to activate an automatic clip-delivery mode based on the attitude data and determine whether the ligating clip is placed on the clip jaw, wherein the clip-cartridge assembly automatically delivers the ligating clip to the clip jaw, if it’s determined to activate the automatic clip- delivery mode and determined that the ligating clip is not placed on the clip jaw or an automatic clip-delivery method performed with the surgical apparatus comprising: acquiring and sending, by the attitude sensing assembly, to the control assembly, the attitude data being configured to indicate a current attitude of the surgical apparatus; determining, by the control assembly, whether to activate an automatic clip-delivery mode according to the attitude data and determining whether the ligating clip is placed on the clip jaw; and controlling a movement of a driving assembly in the handheld component so that the clip- cartridge assembly automatically delivers the ligating clip to the clip jaw, if determining to activate the automatic clip-delivery mode and determining that the ligating clip is not placed on the clip jaw.
Regarding the handheld component is detachably connected to the working component, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the handheld component and the working component as taught by Tan to be detachably connected, as it making separable what was known to be formed from an integral part, which is an obvious engineering choice (see MPEP 2144.04 V).
Shelton, IV teaches an automatic clip-delivery method performed with a surgical apparatus (700)(Figs. 17- 19) comprising: wherein the surgical apparatus comprising: an end effector (702), a shaft assembly (740), an attitude sensing assembly (position sensor 734) and a control assembly (control circuit 710), electrically connected with the attitude sensing assembly (Paragraph 0615); wherein the attitude sensing assembly is configured to acquire attitude data of the surgical apparatus and send the attitude data to the control assembly (Paragraphs 0615- 0617), the control assembly is configured to determine whether to activate an automatic delivery mode based on the attitude data (Paragraph 0518 teaches that the control assembly (710) is programmed to control functions of the end effector based on data, and that it can be programmed to select a firing control program. Therefore, when it receives the data from the attitude sensing assembly, the control assembly can decide whether to fire or not.); and
acquiring and sending, by the attitude sensing assembly, to the control assembly, the attitude data being configured to indicate a current attitude of the surgical apparatus (Paragraphs 0615- 0617); determining, by the control assembly, whether to activate an automatic clip-delivery mode according to the attitude data (Paragraph 0518 teaches that the control assembly (710) is programmed to control functions of the end effector based on data, and that it can be programmed to select a firing control program. Therefore, when it receives the data from the attitude sensing assembly, the control assembly can decide whether to fire or not).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the surgical apparatus as taught by Tan to include an attitude sensing assembly and a control assembly as taught by Shelton, IV, as it has been held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (MPEP 2144) and including these assemblies would make the surgical apparatus an automatic device.
Tan and Shelton, IV do not teach the step of determining whether the ligating clip is placed on the clip jaw; and controlling a movement of a driving assembly in the handheld component so that the clip-cartridge assembly automatically delivers the ligating clip to the clip jaw, if determining to activate the automatic clip-delivery mode and determining that the ligating clip is not placed on the clip jaw or wherein the surgical apparatus further comprises: a clip-cartridge assembly, located in the firing sleeve and configured to provide a ligating clip and to deliver the ligating clip and wherein the control assembly is configured to determine whether the ligating clip is placed on the clip jaw, wherein the clip-cartridge assembly automatically delivers the ligating clip to the clip jaw, if it’s determined to activate the automatic clip- delivery mode and determined that the ligating clip is not placed on the clip jaw.
However, Shelton, IV teaches in a second embodiment, a similar surgical apparatus (clip applier 71600)(Figs. 77)(Paragraph 0446) comprising clip jaws (first jaw 71610a and 71610b), a ligating clip (71604)(Paragraph 0002), a clip-cartridge assembly (clip magazine 70650), a sensor circuit and a control assembly (Paragraph 0446) configured to determine the position of the clip in relation to the jaw (Paragraphs 0446- 0447)(As the control assembly determines the position, it would determine whether the clip is on the jaw.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the control system of the combination to be configured to determine the position of the clip in relation to the jaw as taught in the second embodiment of Shelton, IV, since this allows the system to locate the clip during a procedure (Paragraph 0446).
The combination does not teach the step of controlling a movement of a driving assembly in the handheld component so that the clip-cartridge assembly automatically delivers the ligating clip to the clip jaw.
However, Shelton, IV teaches in a third embodiment a surgical apparatus which has a clip applier and a control system that can automatically load a clip into the jaws of the clip applier when the system detects that the clip applier is in position (Paragraph 0464).
It would have been obvious to one of ordinary skill in the art to modify the control system of the combination to be able to automatically load a clip into the jaws of the clip applier as taught in the third embodiment of Shelton, IV, since Shelton, IV teaches that this arrangement “reduces the time needed to load the clip applier after being inserted into a patient” (Paragraph 0464).
Regarding the control system being configured to determine that the ligating clip is not placed on the clip jaw, as the combination has a control system that detects the position of the clip on the jaws, it would therefore be able to determine if a ligating clip is present on the jaws, and then load a clip when one is needed to perform an operation.
The combination does not teach wherein the attitude sensing assembly comprises an acceleration sensor, and the attitude data comprises acceleration data of the surgical apparatus.
However, Shelton, IV teaches that the control assembly 710 can be in contact with an accelerometer (sensor 738) that is placed on the end effector of the surgical apparatus (Paragraph 0628, 0630).
It would have been obvious to one of ordinary skill in the art to modify the attitude sensing assembly as taught by the combination to include an accelerometer as taught by Shelton, IV, as the accelerometer determines the acceleration of the surgical apparatus and aids in determining distance parameters (Paragraph 0628).
Regarding the attitude data comprising the acceleration data of the surgical apparatus, as the accelerometer is a part of the attitude assembly in the combination, the acceleration data from the accelerometer would be a part of the data.
Regarding wherein when a number of ligating clip having been delivered to the clip jaw is zero, the control assembly is further configured to determine to activate the automatic clip-delivery mode, if a variation amount of acceleration data within a first preset time period is matched with a first template variation rule and when a number of the ligating clip having been delivered to the clip jaw is greater than zero, the control assembly is further configured to determine to activate the automatic clip-delivery mode, if a variation amount of acceleration data within a second preset time period is not matched with a second template variation rule, as Shelton, IV teaches an accelerometer on the end effector and therefore the clip jaw, and the control assembly (710) of the combination is taught to comprise a microprocessor that can execute instructions, it would be obvious to one of ordinary skill in the art to configure the control assembly to accomplish these functions in accordance to the data received from the sensor. Furthermore, as this language is functional, the structure only needs to have the ability to complete the function, which the control assembly would be able to do as the microprocessor allows for the computation of data and the issuing of commands (Shelton, Paragraphs 0517 and 0518).
Regarding controlling a movement of a driving assembly in the handheld component, as it would have been obvious to automate the device of Tan according to Shelton, IV, it would have been obvious to one of ordinary skill in the art to control the movement of the driving assembly in the handheld component in order to automatically deliver a ligating clip.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tan et al. (CN 108348259) in view of Shelton, IV et al. (US 2019/0201136) as evidenced by Landau et al. (2009) Industrial Engineering and Ergonomics: Visions, Concepts, Methods, and Tools, as applied to claim 12 above, in further view of Shelton, IV et al. (US 2019/0125360).
Regarding claim 18, Tan and Shelton, IV make obvious the apparatus as discussed above.
Tan further teaches a driving assembly (128, 129a, 125), disposed in the handheld component (see annotated Fig. 9 below); and a transmission assembly (118, 129b, 135) and a pushing rod (132), both disposed in the working component (see annotated Fig. 9 below), wherein the transmission assembly is connected to the driving assembly, and the pushing rod is connected to the transmission assembly (see annotated Fig. 9 below).
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The combination does not teach wherein the pushing rod is configured to move under in axially reciprocating motion under a drive of the driving assembly and the transmission assembly, so as to push the clip- cartridge assembly to automatically deliver the ligating clip to the clip jaw.
Shelton, IV (‘360) teaches a similar surgical apparatus a similar surgical apparatus (clip applier 71600)(Figs. 77)(Paragraph 0446) comprising clip jaws (first jaw 71610a and 71610b), a ligating clip (71604)(Paragraph 0002), a clip-cartridge assembly (clip magazine 70650), a sensor circuit and a control assembly (Paragraph 0446) configured to determine the position of the clip in relation to the jaw (Paragraphs 0446- 0447)(As the control assembly determines the position, it would determine whether the clip is on the jaw.) and a driving assembly (electric motor), a transmission assembly (drive screw 161), a pushing rod (firing member 165, firing nut 163), wherein the transmission assembly is connected to the driving assembly, and the pushing rod is connected to the transmission assembly (Paragraph 0361), wherein the pushing rod is configured to move in an axially reciprocating motion under a drive of the driving assembly and the transmission assembly, so as to push the clip- cartridge assembly to automatically deliver the ligating clip to the clip jaw (Paragraph 0361- 0362).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by the combination to have the driving assembly, transmission assembly, and pushing rod as taught by Shelton, IV (‘360), in order to automate the clip delivery process and as it has been held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (MPEP 2144).
Regarding claim 19, Tan, Shelton, IV, and Shelton, IV (‘360) make obvious the apparatus as discussed above.
The combination does not teach the apparatus further comprising: a motor circuit, disposed in the handheld component, wherein one end of the motor circuit is connected to the control assembly, and the other end of the motor circuit is connected to the driving assembly, the motor circuit is configured to receive a control signal from the control assembly and to control a movement of the driving assembly according to the control signal; and an automatic clip-delivery switch, connected to the control assembly; wherein the automatic clip-delivery switch is configured to send an automatic clip-delivery signal to the control assembly in the case that the automatic clip-delivery switch is triggered; wherein the control assembly is further configured to, upon receiving the automatic clip- delivery signal, determine to activate the automatic clip-delivery mode and send an automatic clip- delivery control signal to the motor circuit, if a variation amount of acceleration data within a second preset time period is not matched with a second template variation rule; and wherein the motor circuit is configured to control a movement of the driving assembly according to the automatic clip-delivery control signal, so that the transmission assembly drives the pushing rod to push the clip-cartridge assembly to automatically deliver the ligating clip to the clip jaw.
Shelton, IV teaches a motor circuit (motor controllers 708a- 708e), wherein one end of the motor circuit is connected to the control assembly (Paragraph 0618), and the other end of the motor circuit is connected to the driving assembly (Paragraph 0620), the motor circuit is configured to receive a control signal from the control assembly and to control a movement of the driving assembly according to the control signal (Paragraph 0619- 0621).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the surgical apparatus as taught by Tan to include an attitude sensing assembly and a control assembly as taught by Shelton, IV, as it has been held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (MPEP 2144) and including these assemblies would make the surgical apparatus an automatic device.
Regarding the motor circuit disposed within the handheld component, since the motor circuit is a part of the device and connects with the drive assembly, which is taught by Tan to be within the working component (see annotated Fig. 9 below) and the control circuit, it would have been obvious to one of ordinary skill in the art that the motor circuit is disposed within the device. As there are a limited amount of options to place the motor circuit within the device, that being the handheld component, the working component, or the shaft, it would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp”. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding an automatic clip-delivery switch, connected to the control assembly; wherein the automatic clip-delivery switch is configured to send an automatic clip-delivery signal to the control assembly in the case that the automatic clip-delivery switch is triggered; wherein the control assembly is further configured to, upon receiving the automatic clip- delivery signal, determine to activate the automatic clip-delivery mode and send an automatic clip- delivery control signal to the motor circuit, if a variation amount of acceleration data within a second preset time period is not matched with a second template variation rule; and wherein the motor circuit is configured to control a movement of the driving assembly according to the automatic clip-delivery control signal, so that the transmission assembly drives the pushing rod to push the clip-cartridge assembly to automatically deliver the ligating clip to the clip jaw, as discussed above, it has been held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (MPEP 2144), therefore, as the automatic clip-delivery switch activates the automatic clip-delivery signal, it would be obvious to include it and its features in order to automate the device of the combination. Furthermore, the automatic clip-delivery switch would replace the manually activated trigger as taught by Tan, in order to create an automatic system.
Response to Arguments
Applicant's arguments filed April 25th, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments, see Pages 16- 19, regarding the rejection of claims 12-17 and 22 under 35 U.S.C. 103 over Tan et al. (CN 108348259) in view of Shelton, IV et al. (US 2019/0201136), and the rejection of claims 18- 19 under 35 U.S.C. 103 over Tan et al. in view of Shelton IV et al. (‘136) in further view of Shelton IV et al. (US 2019/0125360).
Applicant’s arguments regarding that Shelton IV ‘136 does not teach the limitation “the control assembly is configured to determine whether to activate an automatic clip-delivery mode based on the attitude data and determine whether the ligating clip is placed on the clip jaw” since the control circuit (710) performs various functions based on tissue conditions. This argument is not persuasive, since Shelton IV ‘136 teaches that the control circuit can control functions of the end effector based on tissue conditions that are sensed “either directly or indirectly” (Paragraph 0617), one of ordinary skill in the art would recognize that attitude data received from the end effector indirectly communicates tissue conditions such the thickness of the tissue, as the attitude data would be affected by differing thicknesses of tissues, such as affecting how quickly the end effector is able to close. Therefore the control circuit of Shelton IV ‘136 can be configured to determine whether to activate an automatic clip-delivery mode based on the attitude data and determine whether the ligating clip is placed on the clip jaw.
Regarding Shelton IV ‘136 failing to teach the newly added claim limitations of claim 12, that of “wherein when a number of the ligating clip having been delivered to the clip jaw is zero, the control assembly is further configured to determine to activate the automatic clip- delivery mode, if a variation amount of acceleration data within a first preset time period is matched with a first template variation rule; or when a number of the ligating clip having been delivered to the clip jaw is greater than zero, the control assembly is further configured to determine to activate the automatic clip-delivery mode, if a variation amount of acceleration data within a second preset time period is not matched with a second template variation rule”, this argument is not persuasive. As discussed above, since the control circuit is capable of controlling the functions of the end effector based on tissue conditions that are sensed “either directly or indirectly” (Paragraph 0617), and one of ordinary skill in the art would recognize that attitude data indirectly communicates tissue conditions, Shelton IV ‘136 teaches this limitation. Furthermore, as the limitations of the claim are functional, the control assembly of Shelton IV ‘136 merely needs to have the same structure and be capable of accomplishing the function, that of determining if it needs to activate an automatic delivery mode. Since Shelton IV ‘136 teaches an accelerometer on the end effector, considered the clip jaw (Paragraph 0628, 0630), and as the control assembly contains a microprocessor capable of processing data and issuing instructions (Paragraphs 0517 and 0518), the control assembly would be able to accomplish these functions and determinations based on data received from the end effector and it would be obvious to configure the control assembly to accomplish these functions in accordance to the data that is received from the sensor.
Conclusion
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.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771