DETAILED ACTION
Response to Amendment
The amendment filed January 20, 2026 has been entered. Claims 13, 15-16, 25, 29, and 32 have been amended. Claims 13, 15-19, and 21-33 are currently pending in the application.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below.
Claim Rejections - 35 USC § 103
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.
Claim(s) 13, 15-18, 21-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kesten (US 2016/0008083) in view of Lakin (US 2008/0306490), and further in view of Kuwaki et al. (US 8,188,977).
Regarding claims 13, 21, 22, and 25-27, Kesten discloses a control comprising: (a) a control body shaped to fit on a portion of a medical device (handle 52 Figure1); (b) an integration module comprising a control interface (40, 50, and circuitry generators described in paragraph [0052]), a processor (40), and a communication device, the communication device being operable to communicate with an image guided surgery (IGS) navigation system (paragraph [0052] describes circuitry coupled to sensing coil 100 and field generators 23 communicating with processor 40 so that images of the sinus may be displayed to the physician on the screen 56); and (c) a set of controls positioned on the control body and configured to provide inputs to the control interface when the set of controls are interacted with by a user (see paragraphs [0039], [0069], and [0073]); the processor being configured to: (i) receive a set of inputs via the control interface, wherein the set of inputs describing user interactions with the set of controls (e.g., paragraph [0052] as generating an image); (ii) identify an input based on the set of inputs, and determine whether the input is a navigation input or a device output (the disclosure provides both navigation or image manipulation as well as device input in paragraphs [0076]-[0079]); (iii) if the input is a navigation input, then provide the input to the IGS navigation system, the input being configured to modify the operation of an IGS navigation software being executed by the IGS navigation system (paragraphs [0060], [0066], and [0069]-[0070]); (iv) if the input is a device input the input to the IGS navigation system, the input being configured to modify the operation of the medical device in use with the IGS navigation system (e.g., paragraph [0079] discloses the use of the device to dilate the sinus passage and therefore the control understands how to inflate the dilator rather than to use image capture or some other disclosed feature of the navigation software). Kesten fails to explicitly disclose the set of controls being positioned on the control body and the pattern of user interactions as well as the saddle assembly for being gripped by a user and attaching to the grip portion of the medical device.
Lakin teaches a set of control buttons (406; first and second controls pas per claim 21 which can all provide inputs) positioned on the handle body (paragraph [0038]), and a pattern of user interactions (see paragraph [0049] discussing two short “taps” by the user to provide an input) Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kesten by incorporating a set of controls positioned on the handle body for the purpose of providing structure which can be programmed to allow the user to perform various navigational functions during the diagnostic procedure as per paragraph [0038] and virtually various movements of the scope in the z-axis to inputs for device functions as per paragraph [0049].
As above, Kestin/Lakin fail to teach the device saddle as claimed.
Kuwaki et al. (henceforth Kuwaki) teaches (Figure 1A) a control body (1) comprising a device saddle (formed by main body and arms 15a and 16a), comprising a set of controls (buttons 17a-17c as applied claims 21 and 22), and an integration module comprising a communication device (e.g., Bluetooth; Col. 5, lines 28-32) wherein the device saddle is shaped to fit a grip portion of a device (e.g., Figure 7A, it fits over the top of the control assembly to provide additional functionality), wherein the grip portion is adapted to be gripped by a user (the device comprises buttons for manipulation by the hands of a user; e.g., Col. 4, lines 42-56).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the control handle of Kesten/Lakin to comprise the device saddle of Kuwaki so as to provide a means of adding additional functionality and control to the system during a procedure as taught by Kuwaki (e.g., Col. 3, lines 29-38). It is noted that, even though the device of Kuwaki is drawn to a game controller expansion assembly, the device aims to solve the same stated problem in the art, which is to add functionality to a control assembly. For this reason, it would have been obvious to utilize the saddle of the game controller to increase the functionality of a medical device controller in the same manner. The control body of the cited combination would be modified by the processor element of Lakin to provide the input determination means for controlling any desired software as desired.
Regarding claims 15 and 29-32, Kuwaki further teaches a first clamp arm (16a and portion comprising buttons 17a-17c) extending from the device saddle (Figure 1A), a second clamp arm (15a) extending from the device saddle opposite the first clamp arm (Figure 1A), and a control module (section of arm comprising buttons 17a-17c), comprising a set of controls, positioned on the first clamp arm (Figure 1A), the set of controls being positioned on the control module (they’re on the enlarged section of arm 16a), the integration module being positioned within the control module (Col. 5, lines 28-32 disclose communication means such as Bluetooth within key pad 1 for establishing communication with a software), and the first clamp arm and the second clamp arm fitting opposite sides of the portion of the medical device (Figures 1A and 7A).
Regarding claim 16, Kesten/Lakin/Kuwaki teach the claimed invention substantially as set forth above for claim 15, and Kuwaki further teaches the saddle as being shaped to fit the grip portion of a catheter (it can be applied to any medical device which is held in the hand, similar to a game controller).
Regarding claim 17, Kuwaki further teaches wherein the first and second clamp arms are biased toward each other (e.g., Col. 3, line 66-Col. 4, line 28 disclose that the arms have a deformable range based on the elasticity of the holding portions of the arms for securely engaging the controller body).
Regarding claim 18, Kuwaki further teaches wherein an interior side of each of the first and second clamp arms comprises an attachment feature adapted to increase the force necessary to remove the control body from the dilation catheter (e.g., hook portions 15b and 16b; Col. 6,lines 39-59 disclose the hook portions for securing the saddle to the controller and to prevent unwanted movement).
Regarding claim 23, Kesten/Lakin fail to explicitly disclose any of the claimed movements via the set of controls, however, Lakin discloses that the buttons can be programmed to allow the user to perform various navigational functions (paragraph [0038]. It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the buttons of Lakin to move a cursor as claimed as it represents a well-known means of interface navigation which one of ordinary skill would consider as one of the disclosed various navigational functions set forth by Lakin).
Regarding claim 24, Kesten further discloses (Figure 1) wherein the control module is sealed to prevent exposure of the integration module to liquids during sterilization of the medical device (all portions of the handle assembly of Figure 1 as well as the computer interface comprise cases which are capable of preventing the exposure of internal components as claimed).
Regarding claim 28, Kesten further discloses the communication device being configured to wirelessly transmit the input to the IGS navigation system (paragraph [0046] discloses the use of wireless transmission to the console).
Regarding claim 33, the device of Kesten/Lakin/Kuwaki further teaches the integration module being positioned within the control module (the control module of Kesten controls all functions of the IGS system as set forth above for claim 13 and would therefore include any integration thereof; therefore, the extension of functionality provided by the saddle of Kuwaki would provide inputs to the same control means).
Claim 19 rejected under 35 U.S.C. 103 as being unpatentable over Kesten in view of Lakin in view of Kuwaki, and further in view of Farr et al. (US 2011/0028790).
Regarding claim 19, Kesten/Lakin/Kuwaki teach the claimed invention substantially as set forth above for claim 13, but fail to explicitly disclose a disposable battery.
Farr et al. (henceforth Farr) teaches a medical device comprising a display powered by a disposable battery (paragraph [0068]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Kesten/Lakin to include the disposable battery powered display of Farr so as to allow the display to be powered in the absence of mains power as is known in the art and taught by Farr.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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