DETAILED ACTION
This action is pursuant to the claims filed on 12/29/2025 Claims 1-11 are pending. A first action on the merits of claims 1-11 is as follows.
Response to Amendment
Applicant’s amendment to the claims are acknowledged and entered accordingly.
Claim Objections
Claim 1 is/are objected to because of the following informalities:
Claim 1 line 13; “… and said plane are coincident a said neuromonitoring gun system enabling …” it appears the presence of ‘a’ is a typographical error and should be replaced with a semicolon or comma.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank (U.S. PGPub No. 2015/0223894) in view of Tarello (U.S. Patent No. 4,518,384).
Regarding claim 1, Burbank teaches A pre-operative electrode-dispensing neuromonitoring gun system (see Fig 1), comprising: a dispensing device having a case (Fig 1, case of device), a trigger (Fig 1, trigger 22), an elongated pusher having an axis ([0021, 0092] Fig 13-15B, pusher 34); and a cartridge dimensioned and configured for holding a plurality of elongated electrodes (Fig 1 and 13 cassette 26 and gun track 12 with electrodes 11 therein as shown in Fig 3), each electrode having first and second elongated parallel subdermal leads disposed in a single plane (Figs 1, 3, 13 each electrode has two subdermal leads disposed in a single plane), all such single planes within said cartridge being parallel, all said electrodes in said cartridge being disposed within virtual respective parallel vertically spaced planes (see Figs 1, 3, and 13), each electrode facing away from said trigger (Fig 1 and 13, each electrode faces away from the trigger 22); said neuromonitoring gun system enabling the user to perceive any resistance to entrance of an electrode into a patient when the operator initiates movement of an electrode by movement of said trigger (Fig 14 [0092-0093], actuation of trigger from “ready” to “fired” position propels the pusher rail 34 forward which implants the needles 11 into tissue; thus the system enables a user to perceive resistance to entrance of an electrode into patient as said resistance of electrode would be necessarily felt by the pusher rail 34 and finger on trigger 22) and said neuromonitoring gun system allows an operator to selectively stop and/or change the rate of advance responsive to perceived resistance (the system of Burbank allows a user to selectively stop pressing a trigger and/or press the trigger faster or slower based on a user’s perceptions).
Burbank fails to teach each electrode being spring biased to a higher elevation with the highest electrode aligned with said pusher prior to dispensing that electrode; said cartridge extending downward from said common plane in which said axis of said pusher and said plane are coincident.
In related prior art, Tarello teaches a similar gun-like device for dispensing an object into a user for medical purposes therein (Figs 1 and 11-13, examiner notes Figs 11-13 are an alternative embodiment embodying the principles of Fig 1) wherein each electrode being spring biased to a higher elevation with the highest electrode aligned with said pusher prior to dispensing that electrode (Figs 11-13, spring 248 biases each container 218 to a highest elevation, with the highest container 218 being aligned with pusher 264); said cartridge extending downward from said common plane in which said axis of said pusher and said plane are coincident (Figs 13, cartridge extends downward from common plane of highest ‘electrode’ 218 and pusher 264, both of which have coincident axes). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge of Burbank in view of Tarello to incorporate a spring biased cartridge extending downward on an underside of the device such that a highest biased electrode is aligned with said pusher prior to dispensing to arrive at the device of claim 1. Doing so would be a simple substitution of one well-known gun-like cartridge direction (Burbank with cartridge extending upward from body of ‘gun’) for another well-known gun-like cartridge direction (Tarello, spring biased cartridge extending downward from body of ‘gun’) to yield the predictable result of a gun-like device capable of automatically and repeatedly dispensing its contents to a patient for medical diagnosis/treatment therein (Tarello contemplates multiple embodiments with the cartridge extending upwards (Fig 1), downwards (Fig 13), or even sideways (Fig 16) relative to the device body to yield the same results).
Regarding claim 2, Burbank teaches wherein the trigger has a proximal portion (Figs 14 and 28-29, trigger has proximal portion), the pusher has a proximal portion (Fig 14 proximal portion of pusher 34), and the proximal portion of the trigger is coupled with the proximal portion of the pusher (Fig 14 and [0092], proximal portion of trigger is coupled with proximal pusher 34 via link 50).
Regarding claim 3, Burbank/Tarello teaches the device of claim 1 as stated above, Tarello further teaches a cartridge slider that biases respective electrodes within said cartridge upwardly (Fig 13, cartridge slider 250 with spring 248). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the cartridge of Burbank in view of Tarello to incorporate the cartridge extending downward as claimed with a cartridge slider for biasing respective electrodes upwardly to arrive at the device of claim 3. Doing so would be obvious to one of ordinary skill in the art as the use of cartridge sliders for biasing ‘ammunition’ in a cartridge of a gun-like device is well-known in the art to yield the predictable result of ensuring proper placement of each successive ‘bullet’ against the pusher after ‘firing’ the gun-like device for repeated use.
Regarding claim 4, Burbank/Tarello teaches the device of claim 1 as stated above, Tarello further teaches a cartridge slider (Fig 13 cartridge slider 250), a cartridge stop (Fig 13 wall 244 interpreted as cartridge stop), and a compression spring disposed between the cartridge slider and the cartridge stop (Fig 13 spring 248). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the cartridge of Burbank in view of Tarello to incorporate the cartridge extending downward as claimed with a cartridge slider, cartridge stop and spring for biasing respective electrodes upwardly to arrive at the device of claim 4. Doing so would be obvious to one of ordinary skill in the art as the use of cartridge sliders for biasing ‘ammunition’ in a cartridge of a gun-like device is well-known in the art to yield the predictable result of ensuring proper placement of each successive ‘bullet’ against the pusher after ‘firing’ the gun-like device for repeated use.
Regarding claim 5, Burbank teaches wherein at least one of the plurality of electrodes comprises a housing, a first wing-like casing coupled with the housing via a first hinge, and a second wing-like casing coupled with the housing via a second hinge (Figs 5-8 and 11, housing with first and second wings 20/21 connected via hinges 14a-b).
Regarding claim 6, Burbank teaches wherein at least one of the plurality of electrodes comprises a first lead and a second lead (Figs 5-8 and 11, each electrode block assembly comprises first and second needle electrodes 11).
Regarding claim 7, Burbank teaches wherein at least one of the plurality of electrodes comprises a housing (Fig 5 housing 18), a first wing-like casing coupled with the housing via a first hinge (Fig 7 and 11, first wing 20 connected via hinge 14a), a second wing-like casing coupled with the housing via a second hinge (Fig 7 and 11, second wing 21 connected via hinge 14b), a first lead coupled with the housing, and a second lead coupled with the housing (Fig 5, 7 and 11, first and second electrode leads 11 connected to housing 18).
Regarding claim 8, Burbank teaches wherein at least one of the plurality of electrodes comprises a plug (Figs 7-8 and 11, pins 14a-b function as male plugs to fit within female plugs of wings 20/21 respectively of each wire block assembly 16 of each electrode ; examiner notes ‘plug’ is being interpreted under its broadest reasonable interpretation and need not be an electrical plug).
Regarding claim 9, Burbank teaches wherein at least one of the plurality of electrodes comprises a female plug (Figs 7-8 and 11, pins 14a-b function as male plugs to fit within female plugs of wings 20/21 respectively).
Regarding claim 10, Burbank teaches wherein at least one of the plurality of electrodes comprises a male plug (Figs 7-8 and 11, pins 14a-b function as male plugs to fit within female plugs of wings 20/21 respectively).
Regarding claim 11, Burbank teaches wherein at least one of the plurality of electrodes comprises an electrode plug and an electrode housing (Figs 3 and 5, portion of wire assembly 14 acts as female plug to receive proximal portion of each lead 11; wire assembly 14 defines an electrode housing for housing electrode components of Fig 3), and wherein the electrode plug and the electrode housing are provided together as a single solid body (Fig 5, wire assembly 14 is a single solid body).
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
Applicant fails to consider the Burbank reference in the remarks with respect to the newly recited limitations directed to the enabling of a user to perceive resistance.
In response to applicant's argument that the combination of record does not disclose the enabling the user to perceive any resistance to entrance of an electrode into a patient, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, the Burbank reference discloses a trigger 22 mechanically connected to an elongated link 50 and pusher rail 34 that advance forward upon actuation of a trigger to push needles 11 into tissue. This configuration necessarily would enable a user to perceive any resistance of the needle entering tissue to stop pressing of the trigger and/or provide more force to the trigger to change the rate of advancement. Furthermore, this configuration is similar to that of applicant’s configuration in which a trigger 120 is mechanically connected to a pusher 150 that advances the needle electrode 108 into tissue, which would enable the newly recited claimed function stated above.
Conclusion
THIS ACTION IS MADE FINAL. 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 Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794