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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-19, drawn to an apparatus, classified in A61B17/122.
II. Claim 20, drawn to a method, classified in B25J9/1689.
The inventions are independent or distinct, each from the other because:
Inventions Group I and Group II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the process as claimed can be practiced by another and materially different apparatus or by hand, such as used during a procedure of a manipulator or with an apparatus with only one input, not two.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Andrew Khouzam on June 4th, 2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1- 19. Affirmation of this election must be made by applicant in replying to this Office action. Claim 20 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claim 18 is objected to because of the following informalities:
Claim 18, Lines 4-5 states “a fully open position”, it is suggested to change this to “a fully closed position”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 8, 11, 13- 15, 18, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tanaka et al. (US 2022/0183697).
Regarding claim 1, Tanaka (Tanaka et al.) teaches an apparatus (clip applier system 1)(Figs. 1-5)(abstract, Paragraph 0035) comprising: an instrument (clip applier 2), the instrument including: a shaft assembly, and an end effector at a distal end of the shaft assembly (see annotated Fig. 1 below), the end effector being operable to transition between a fully open configuration and a fully closed configuration (Paragraphs 0035 and 0038); a first user input (second changing switch 5b), the first user input being operable to generate an activation signal (Paragraphs 0042 and 0065); and a control module (control device 3) in communication with the instrument (Paragraph 0040), the control module further being in communication with the first user input (Paragraphs 0041 and 0065), the control module being configured to transition between a safe operating mode (half-closed clip mode) and a fire operating mode (opening degree control mode, gripping force control mode)(Paragraphs 0042 and 0064- 0069), wherein:
in the safe operating mode, the control module is configured to prevent or restrict closure of the end effector (Paragraphs 0065- 0068), and
in the fire operating mode, the control module is configured to generate a power drive signal that drives closure of the end effector to the fully closed configuration (Paragraphs 0069- 0071).
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Regarding claim 2, Tanaka teaches the apparatus as discussed above.
Tanaka further teaches the end effector being configured to receive a clip (8)(Paragraphs 0004 and 0035), the end effector being operable to drive closure of the clip as the end effector transitions from the fully open configured to the fully closed configuration (Paragraphs 0035, 0064, and 0070)(see Fig. 1).
Regarding claim 3, Tanaka teaches the apparatus as discussed above.
Tanaka further teaches the apparatus further comprising a clip (8), the clip being received in the end effector (Paragraphs 0004 and 0035), wherein the clip is configured to transition from a fully open state to a fully closed state as the end effector transitions from the fully open configuration to the fully closed configuration (Paragraphs 0035, 0064, and 0070)(see Fig. 1).
Regarding claim 4, Tanaka teaches the apparatus as discussed above.
Tanaka further teaches wherein the end effector is operable to reach a predetermined partially closed configuration (half-closed clip in the half- closed clip mode) between the fully open configuration and the fully closed configuration (Paragraphs 0064- 0069), the clip being configured to reach a partially closed state (half- closed) between the fully open state and the fully closed state in response to the end effector reaching the predetermined partially closed configuration (Paragraphs 0035 and 0064- 0069), and wherein:
in the safe operating mode, the control module is configured to allow closure of the end effector up to the predetermined partially closed configuration (Paragraphs 0064- 0069), and
in the safe operating mode, the control module is configured to prevent closure of the end effector beyond the predetermined partially closed configuration (Paragraphs 0064- 0069).
Regarding claim 8, Tanaka teaches the apparatus as discussed above.
Tanaka further teaches the apparatus further comprising a robotic arm, the instrument being coupled with the robotic arm (Paragraph 0035).
Regarding claim 11, Tanaka teaches the apparatus as discussed above.
Tanaka further teaches the apparatus further comprising a second user input (changing switch 5a), the control module being configured to transition from the safe mode to the fire mode in response to a mode transition signal from the second user input (Paragraphs 0070- 0072).
Regarding claim 13, Tanaka teaches the apparatus as discussed above.
Tanaka further teaches the control module being configured to transition from the safe mode to the fire mode in response to the second user input being actuated for a predetermined period of time (Paragraphs 0069- 0072).
Regarding claim 14, Tanaka teaches the apparatus as discussed above.
Tanaka further teaches the control module being configured to remain in the fire mode after the second user input has been actuated for the predetermined period of time (Paragraphs 0069- 0072).
Regarding claim 15, Tanaka teaches the apparatus as discussed above.
Tanaka further teaches the control module being configured to transition from the safe mode to the fire mode in response to the second user input being actuated (When switch 5b is turned off and switch 5a is changed as described in Paragraphs 0070- 0072), the control module being further configured to transition from the fire mode back to the safe mode in response to cessation of actuation of the second user input (When switch 5b is turned on and switch 5a is turned off, Paragraphs 0064- 0069, and 0076).
Regarding claim 18, Tanaka teaches the apparatus as discussed above.
Tanaka further teaches the end effector including: a first jaw and a second jaw (pair of jaws 11), the first and second jaws being operable to transition between a fully open position and a fully closed position, thereby providing the end effector in the fully open configuration and the fully closed configuration, respectively (Paragraphs 0035, 0064, and 0070)(see Fig. 1).
Regarding claim 19, Tanaka teaches an apparatus (clip applier system 1)(Figs. 1-5)(abstract, Paragraph 0035), comprising: a first user input (second changing switch 5b), the first user input being operable to generate an activation signal (Paragraphs 0042 and 0065); and a control module (control device 3) in communication with an instrument (clip applier 2)(Paragraph 0040), the control module further being in communication with the first user input (Paragraphs 0041 and 0065), the control module being configured to transition between a safe operating mode (half-closed clip mode) and a fire operating mode (opening degree control mode, gripping force control mode)(Paragraphs 0042 and 0064- 0069), wherein:
in the safe operating mode, the control module is configured to prevent or restrict closure of the instrument (Paragraphs 0065- 0068), and
in the fire operating mode, the control module is configured to generate a power drive signal that drives closure of the instrument to a fully closed position (Paragraphs 0069- 0071).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al. (US 2022/0183697) in view of Hart et al. (WO 97/38634).
Regarding claim 5, Tanaka teaches the apparatus as discussed above.
Tanaka teaches the clip is made of a metal, resin or similar material (Paragraph 0004).
Tanaka does not teach wherein the clip is capable of returning from the partially closed state to the fully open state after reaching the partially closed state, and wherein the clip is unable to return from the partially closed state to the fully open state after surpassing the partially closed state.
Hart (Hart et al.) teaches a clip applier (10) for applying a clip (24)(abstract), wherein the clip is made of titanium (Page 19, Lines 9- 13) and wherein the clip is capable of returning from a partially closed state to a fully open state after reached the partially closed state (Page 6, Lines 23- 32), and wherein the clip is unable to return from the partially closed state to the fully open state after surpassing the partially closed state (see Figs. 8A- 8C)(Page 20, Lines 22- 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the material of the clip to be titanium and have the properties of the clip as taught by Hart, since Tanaka teaches that the clip can be made of a metal (Paragraph 0004) and titanium is a metal (Hart, Page 19, Lines 9- 13) and as Hart teaches that the clip is able to be repositioned (Page 5, Lines 16- 19).
Regarding claims 6 and 7, Tanaka makes obvious the apparatus as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the material of the clip to be titanium and have the properties of the clip as taught by Hart, since Tanaka teaches that the clip can be made of a metal (Paragraph 0004) and titanium is a metal (Hart, Page 19, Lines 9- 13) and as Hart teaches that the clip is able to be repositioned (Page 5, Lines 16- 19).
The combination further teaches wherein the clip is configured to plastically deform after surpassing the partially closed state (Hart, see Fig. 8C)(Page 20, Lines 22- 25) and wherein the clip includes a malleable feature (Hart, Page 19, Lines 9- 13) preventing the clip from returning to the fully open state after surpassing the partially closed state (Hart, see Fig. 8C)( Page 20, Lines 22- 25).
Alternatively, as Hart teaches that the clip is made from a similar material as set forth within the claim limitation, that of a malleable material (Page 19, Lines 9- 13), then the clip of Hart and therefore the combination would be capable of plastic deformation after surpassing the partially closed state.
Claim(s) 9, 10, 12, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al. (US 2022/0183697) in view of Richmond et al. (US 2018/0296287).
Regarding claim 9, Tanaka teaches the apparatus as discussed above.
Tanaka does not teach wherein the first user input comprises one or more pivoting activation arms, the one or more pivoting activation arms being pivotable to generate the activation signal.
Richmond (Richmond et al.) teaches a similar apparatus (600, 802, and 804)(Figs. 6-8)(abstract) comprising an instrument (600), the instrument including: a shaft assembly (instrument shaft 604) and an end effector (606), a first user input (master grip input mechanism 806), the first user input being operable to generate an activation signal (master grip input signal 100)(Paragraph 0039 and 0040), and a control module (control console 804) in communication with the instrument, the control module further being in communication with the first user input (Paragraph 0033 and 0036), wherein the first user input comprises one or more pivoting activation arms (levers 900a, 900b), the one or more pivoting activation arms being pivotable to generate the activation signal (Paragraphs 0039- 0040).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first user input as taught by Tanaka to be the first user input as taught by Richmond, since Richmond teaches that this type of input is well known in the art for operating an apparatus used during surgery (Paragraph 0034) and is a type of actuator (Paragraph 0033).
Regarding claim 10, Tanaka teaches the apparatus as discussed above.
Tanaka further teaches a viewing assembly (display device 7), the viewing assembly further being operable to generate a visual indicator, the visual indicator indicating whether the control module is in the safe mode or the fire mode (As Tanaka teaches in Paragraph 0043, the display device warns or informs the surgeon of various information, therefore the device is capable of indicating whether the control module is in the safe mode or the fire mode).
Tanaka does not teach the apparatus further comprising a console, the first user input being integrated into the console, the console further including a viewing assembly, the viewing assembly being operable to display an endoscopic view of the end effector in a surgical field.
Richmond (Richmond et al.) teaches a similar apparatus (600, 802, and 804)(Figs. 6-8)(abstract) comprising an instrument (600), the instrument including: a shaft assembly (instrument shaft 604) and an end effector (606), a first user input (master grip input mechanism 806), the first user input being operable to generate an activation signal (master grip input signal 100)(Paragraph 0039 and 0040), and a control module (control console 804) in communication with the instrument, the control module further being in communication with the first user input (Paragraph 0033 and 0036), the apparatus further comprising a console (surgeon console 802), the first user input being integrated into the console (Paragraphs 0033 and 0035), the console further including a viewing assembly (display 812), the viewing assembly being operable to display an endoscopic view of the end effector in a surgical field (Paragraph 0036).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the apparatus as taught by Tanaka to have a console and to display an endoscopic view of the end effector as taught by Richmond, since Richmond teaches that this view allows for a surgeon to visualize the location of the surgery (Paragraph 0036) and the console is known in the art to be used with robotic systems and enables a surgeon to perform a surgery telerobotically (Paragraph 0003).
Regarding claim 12, Tanaka teaches the apparatus as discussed above.
Tanaka does not teach the second user input comprising a foot- actuated pedal.
Richmond (Richmond et al.) teaches a similar apparatus (600, 802, and 804)(Figs. 6-8)(abstract) comprising an instrument (600), the instrument including: a shaft assembly (instrument shaft 604) and an end effector (606), a first user input (master grip input mechanism 806), the first user input being operable to generate an activation signal (master grip input signal 100)(Paragraph 0039 and 0040), and a control module (control console 804) in communication with the instrument, the control module further being in communication with the first user input (Paragraph 0033 and 0036), a second user input (foot pedals 808), wherein the second user input comprises a foot- actuated pedal (Paragraph 0033 and 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the second user input as taught by Tanaka to be a pedal as taught by Richmond, as Tanaka teaches that the second user input can be an actuator such as a switch (Paragraph 0042) and Richmond teaches a type of actuator, that of a pedal (Paragraph 0033), and as Richmond teaches that the second user input acts as an additional safety feature during an operation (Paragraph 0057).
Regarding claim 17, Tanaka teaches the apparatus as discussed above.
Tanaka does not teach the apparatus further comprising a tower, the control module being incorporated into the tower.
Richmond (Richmond et al.) teaches a similar apparatus (600, 802, and 804)(Figs. 6-8)(abstract) comprising an instrument (600), the instrument including: a shaft assembly (instrument shaft 604) and an end effector (606), a first user input (master grip input mechanism 806), the first user input being operable to generate an activation signal (master grip input signal 100)(Paragraph 0039 and 0040), and a control module (control console 804) in communication with the instrument, the control module further being in communication with the first user input (Paragraph 0033 and 0036), the apparatus further comprising a tower (surgeon console 802), the control module being incorporated into the tower (Paragraphs 0032- 0035).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the apparatus as taught by Tanaka to be a tower as taught by Richmond, since Richmond teaches that a tower being used during a robotic surgery is well known in the art (Paragraphs 0032- 0034).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al. (US 2022/0183697) in view of Shelton, IV et al. (US 2019/0201146).
Regarding claim 16, Tanaka teaches the apparatus as discussed above.
Tanaka does not teach the control module being further configured to identify a real-time position of the end effector, the control module being configured to transition from the safe operating mode to the fire operating mode based at least in part on the real-time position of the end effector.
Shelton, IV (Shelton, IV et al.) teaches a similar apparatus (23100)(Figs. 89)(abstract and Paragraph 0574) comprising an instrument (23102), the instrument including: a shaft assembly (23120) and an end effector (23130), and a control module (23142) in communication with the instrument (Paragraphs 0574 and 0591), the control module being further configured to identify a real-time position of the end effector, the control module being configured to transition from the safe operating mode to the fire operating mode based at least in part on the real-time position of the end effector (Paragraph 0591).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the control module as taught by Tanaka to identify a real-time position of the end effector and transition from the safe operating mode to the fire operating mode based at least in part on the real-time position of the end- effector as taught by Shelton, IV, since Shelton, IV teaches that this detection prevents the injury of tissue and informs the physician that the end effector is not placed correctly (Paragraph 0591).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Shelton, IV et al. (US 2019/0059897) teaches a similar apparatus (abstract) comprising surgical clip applier (100) with a control module (control system 258)(Paragraphs 0057 and 0081).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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