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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 4/11/25 has/have been acknowledged and is/are being considered by the Examiner.
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) 21-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Truwit (U.S. Pat. 6,752,812) in view of Kuiken et al. (U.S. Pub. 2014/0276454 hereinafter “Kuiken”).
Regarding claim 21, Truwit discloses a device for positioning an electrode at a target site within a patient, the device comprising: a guide socket defining an opening (e.g. 5120); a probe guide (e.g. 4220) having a channel (e.g. 4222) extending therethrough and being at least partially received in the opening of the guide socket so as to permit multi-directional angular positioning of the probe guide relative to the guide socket (e.g. see Figs. 53-54); a clamp (e.g. 230) configured to selectively lock at least one of an orientation or a depth of the probe relative to the guide socket (e.g. see Figs, 4 and 54; [clamp lock]). Truwit teaches the claimed invention as disclosed in detail above but fails to disclose a cup configured to be placed over at least the probe guide and the clamp to inhibit displacement of a probe received through the channel of the probe guide. However, Kuiken teaches that it is known to use a cup (e.g. 110) as set forth in Paragraphs 33-34 to provide a cover that inhibits movement of the probe and reduces stress at the skin-implant interface. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Truwit, with a cup as taught by Kuiken, since such a modification would provide the predictable results of a cup that encases the probe to inhibit movement of the probe and reduces stress at the skin-implant interface.
Regarding claim 22, meeting the limitations of claim 21 above, Truwit further discloses comprising an adhesive layer configured to attach the device to a patient's skin (e.g. 5150).
Regarding claim 23, meeting the limitations of claims 21 and 22 above, Truwit further discloses wherein the guide socket is coupled to the adhesive layer (e.g. see Figs. 53-54).
Regarding claim 24, meeting the limitations of claims 21 and 22 above, Truwit further discloses wherein the adhesive layer (e.g. 5150) defines an aperture aligned with the opening of the guide socket to facilitate insertion of a probe through the patient's skin (e.g. see Figs. 53-54).
Regarding claim 25, meeting the limitations of claim 21 above, Truwit further discloses wherein the guide socket (e.g. 5120) and the probe guide form a ball-and-socket joint (e.g. 4210) that allows rotation of the probe guide about multiple axes (e.g. Figs. 53-54).
Regarding claim 26, meeting the limitations of claim 21 above, Truwit further discloses wherein the guide socket includes a flange extending from a socket portion of the guide socket, the socket portion forming a grommet that receives a tip portion of the probe guide (e.g. see Fig. 54).
Regarding claim 27, meeting the limitations of claim 21 above, Kuiken further teaches wherein the cup defines a recess configured to enclose the guide socket, the probe guide, and the clamp (e.g. 110; as set forth in Paragraphs 33-34).
Regarding claim 28, meeting the limitations of claim 21 above, Truwit further discloses wherein the clamp is configured to compressively engage the probe guide to hold a probe received through the channel of the probe guide at a selected orientation (e.g. 5400; see Fig. 54).
Regarding claim 29, meeting the limitations of claim 21 above, Truwit further discloses wherein the clamp is threadingly coupled to the probe guide (e.g. Col. 40, lines 58-60).
Regarding claims 30-31, Truwit discloses a device configured to facilitate delivery or measurement of electrical signals at a target site in a patient, the device comprising: a guide component (e.g. 5120) having a body portion with a channel (e.g. Col. 40, ll. 2065) therein, the channel configured to receive at least a portion of an instrument capable of delivering or measuring electrical signals (e.g. see Figs. 53-54; [the base has an opening or passageway therein]); a clamp (e.g. 230) disposed about at least a portion of the guide component and adjustable between a released configuration, in which the guide component can be repositioned, and a locked configuration, in which the guide component is immobilized (e.g. Col. 11, ll. 16-31; see Figs, 4 and 54; [clamp lock]). Truwit teaches the claimed invention as disclosed in detail above but fails to disclose a cup configured to be placed over at least the probe guide and the clamp to inhibit displacement of a probe received through the channel of the probe guide. However, Kuiken teaches that it is known to use a cup (e.g. 110) as set forth in Paragraphs 33-34 to provide a cover that inhibits movement of the probe and reduces stress at the skin-implant interface. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Truwit, with a cup as taught by Kuiken, since such a modification would provide the predictable results of a cup that encases the probe to inhibit movement of the probe and reduces stress at the skin-implant interface.
Regarding claim 32, meeting the limitations of claim 30 above, Truwit further discloses wherein the clamp is selected from the group consisting of: a quick lever clamp, a snapper hose clamp, and a knob-type clamp (e.g. 5400).
Regarding claim 33, meeting the limitations of claim 30 above, Truwit further discloses an adhesive layer configured to attach the device to a patient's skin (e.g. 5150).
Regarding claim 34, meeting the limitations of claims 30 and 33 above, Truwit further discloses wherein the guide socket is coupled to the adhesive layer (e.g. see Figs. 53-54).
Regarding claim 35, meeting the limitations of claims 30 and 33 above, Truwit further discloses wherein the adhesive layer has an aperture aligned with the channel of the guide component to enable access to the target site through the patient's skin (e.g. 5150; see Fig. 55).
Regarding claim 36, meeting the limitations of claims 30 and 33 above, Truwit further discloses wherein the guide component includes a spherical portion (e.g. 4210) configured to seat in a corresponding socket coupled to the adhesive layer (e.g. see Fig. 55).
Regarding claims 37, Truwit discloses a device for controlling an orientation and depth of an instrument relative to a target site in a patient, the device comprising: an adhesive layer configured to secure the device onto a patient's skin (e.g. 5150); a guide structure having a passageway configured to receive the instrument (e.g. see Figs. 53-54; [the base has an opening or passageway therein]); a clamp configured to lock the guide structure at a selected orientation and depth relative to the adhesive layer (e.g. Col. 11, ll. 16-31; see Figs, 4 and 54; [clamp lock]). Truwit teaches the claimed invention as disclosed in detail above but fails to disclose a cup configured to be placed over at least the probe guide and the clamp to inhibit displacement of a probe received through the channel of the probe guide. However, Kuiken teaches that it is known to use a cup (e.g. 110) as set forth in Paragraphs 33-34 to provide a cover that inhibits movement of the probe and reduces stress at the skin-implant interface. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Truwit, with a cup as taught by Kuiken, since such a modification would provide the predictable results of a cup that encases the probe to inhibit movement of the probe and reduces stress at the skin-implant interface.
Regarding claim 38, meeting the limitations of claim 37 above, Truwit further discloses wherein the guide structure is rotatable about multiple axes within a corresponding guide socket that is coupled to the adhesive layer (e.g. See Figs. 53-55; Col. 15, ll. 46-49).
Regarding claim 39, meeting the limitations of claim 37 above, Truwit further discloses wherein the adhesive layer defines an aperture aligned with the passageway of the guide structure to facilitate entry of the instrument through the patient's skin (e.g. 5150; see Fig. 55).
Regarding claim 40, meeting the limitations of claim 37 above, Truwit further discloses wherein the cup defines a recess sized to receive the guide structure and the clamp and includes an opening through which at least a portion of the device extends (e.g. 110; as set forth in Paragraphs 33-34).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bishay (U.S. Pub. 2003/0195599) discloses a probe assembly with cap/cup for covering the device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
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