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 .
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, 4-5, 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2021242633A1 to Verzal et al. (hereinafter “Verzal”).
Regarding 1. (Original) Verzal discloses a system (fig 31A) comprising: an introducer configured to navigate a lead for placement near a hypoglossal nerve of a patient (para 0315, introducer, para 0318 “implantation”, para 304, near hypoglossal nerve”, figs 30A-31), the introducer comprising an elongated body defining an introducer lumen; and a lead configured to be disposed within the introducer lumen of the elongated body (para 0315, fig. 31A), the lead comprising (fig. 31A): an elongated shaft defining a longitudinal axis (para 0375, “lead body 3222 [] device 6710”); one or more electrodes disposed on a distal portion of the shaft (para 0380, “electrodes 6716”), the one or more electrodes being configured to be placed near the hypoglossal nerve and configured to stimulate the hypoglossal nerve for treating obstructive sleep apnea (OSA) (para 0001); and a fixation element (para 0379-0380, “anchor elements 8638”) disposed over the distal portion of the elongated shaft (figs 31B), the fixation element comprising (para 0379-0380, “anchor elements 8638”): a distal tip (para 0379-0380, “tip 8623”) configured to penetrate tissue near the hypoglossal nerve (para 0376); and a helix comprising a plurality of coils (para 0380 “anchor element 8638 (e.g. helix, coil, and the like)”), the plurality of coils being configured to engage the tissue near the hypoglossal nerve to secure the lead near the hypoglossal nerve (para 0376).
Regarding 4. (Original) Verzal discloses the system of claim 1, wherein the fixation element is disposed on a distal end of the elongated shaft (fig. 31).
Regarding 5. (Currently Amended) Verzal discloses the system of claim 1, wherein an outer diameter of the fixation element is less than or equal to an outer diameter of the elongated shaft (fig 31C).
Regarding 19. (Currently Amended) Verzal discloses the system of claim 1, wherein a proximal end of the fixation element is separated from a distalmost electrode of the one or more electrodes by a predetermined distance (fig. 31A).
Regarding 20. (Currently Amended) Verzal discloses the system of claim 1, wherein the introducer is configured to be percutaneously inserted into skin of the patient (para 0303).
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 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) 2-3, 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verzal.
Regarding 2. (Original) Verzal discloses the system of claim 1, wherein the one or more electrodes comprises a plurality of electrodes (para 0380-0384 “electrodes 6716”), and wherein the fixation element is disposed between two electrodes of the plurality of electrodes (para 0380-0385, para 0298 “an anchor element comprising an array 3926 of flexible, resilient tines 3927”, MPEP 2144, rearrangement of parts, see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)).
Regarding 3. (Original) Verzal discloses the system of claim 1, wherein the fixation element is proximal to a proximal-most electrode of the one or more electrodes (para 0380-0385, an anchor element comprising an array 3926 of flexible, resilient tines 3927; MPEP 2144, rearrangement of parts, see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)).
Regarding 12. (Currently Amended) Verzal discloses the system of claim 1, wherein the lead further comprises a plurality of protrusions extending from an outer surface of the elongated shaft (para 0733).
Regarding 13. (Original) Verzal discloses the system of claim 12, wherein the plurality of protrusions are configured to engage with the tissue of the patient and prevent rotation of the fixation element within the tissue (para 0733 “suturing to secure the carrier body 11102 relative to surrounding non-nerve tissues to anchor the paddle electrode 11100 securely in stimulating relation”).
Regarding 14. (Currently Amended) Verzal discloses the system of claim 13, further comprising a guide sheath disposed within the introducer lumen and over the elongated shaft of the lead, the guide sheath comprising a plurality of openings, each opening of the plurality of openings being configured to retain a corresponding protrusion of the plurality of protrusions, and wherein when engaged with the plurality of protrusions, the sheath is configured to rotate the lead about the longitudinal axis (para 0315-0317).
Regarding 15. (Currently Amended) Verzal discloses the system of claim 1, wherein the elongated shaft defines a lead lumen, wherein the lead further comprises a locking recess disposed at a distal end of the lead lumen, and wherein the system further comprises: an elongated stylet disposed within the lead lumen, the elongated stylet comprising a locking member disposed on a distal end of the elongated stylet, the locking member being configured to engage with the locking recess (figs 31C-D).
Regarding 16. (Original) Verzal discloses the system of claim 15, wherein when the locking member of the elongated stylet is engaged with the locking recess, the locking member is configured to rotate the lead about the longitudinal axis (para 0380, fig 31C-D).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verzal in view of US 20210290957 to Schulhauser (on IDS).
Regarding 6. (Currently Amended) Verzal discloses the system of claim 1, but fails to disclose wherein the helix defines a distal electrode configured to be placed near the hypoglossal nerve and configured to stimulate the hypoglossal nerve for treating OSA or to sense signals.
Schulhauser from a similar field of endeavor teaches having fixation mechanism along the length or near electrode… electrode 130D of electrical lead 20B has a helical configuration used for fixation (para 0066) and stimulating the hypoglossal nerve to treat OSA using (para 0084). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Verzal with the teachings of Schulhauser to provide the predictable result of treating OSA.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verzal in view of US 6212434 to Scheiner et al. (hereinafter “Scheiner”).
Regarding claim 7. (Original) Verzal discloses the system of claim 6, but fails to disclose wherein the fixation element comprises an insulative material disposed over one or more first coils of the plurality of coils, wherein one or more second coils of the plurality of coils define the distal electrode, and wherein the one or more first coils are proximal to the one or more second coils.
Scheiner, from a similar field of endeavor teaches the fixation helix to be insulated using insulation coating over a portion of the fixation helix so that the impedance is increased for the helix as compared to a helix of the same size and materials without an insulating coating (Col 5, ln 40-65). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Verzal with the known teachings of Scheiner to provide the predictable result of coating all/portion of the helix so that the impedance is increased for the helix as compared to helix of the same size and material without insulating coating.
Regarding 8. (Currently Amended) Verzal as modified by Scheiner renders obvious he system of claim 7, wherein the distal electrode and an electrode of the one or more electrodes are configured to deliver electrical signals to the hypoglossal nerve by transmitting the electrical signals between the distal electrode and the electrode or are configured to sense signals (para 0315, introducer, para 0318 “implantation”, para 304, near hypoglossal nerve”, figs 30A-31).
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verzal in view of US20150374991 to Morris et al. (hereinafter “Morris” – on IDS)
Regarding 9. (Currently Amended) Verzal discloses the system of claim 1, but fail to disclose wherein the plurality of coils of the helix define a variable pitch.
Morris, from a similar field of endeavor teaches having a fixation member, anchor portion to temporary anchor the device wherein the fixation member have a variety of lengths and helical pitches [] desirable to increase the pitch to increase the amount of surface area engaging tissue of the wall (para 0120, 0105). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Verzal with the teachings of Morris, because doing so would allow for adjusting the pitch, which provides the predictable result of adjusting the amount of surface area engaging tissue of the wall.
Regarding 10. (Currently Amended) Verzal discloses the system of claim 1, but fails to explicitly disclose wherein the plurality of coils of the helix define a constant pitch.
Morris, from a similar field of endeavor teaches having a fixation member, anchor portion to temporary anchor the device wherein the fixation member have a variety of lengths and helical pitches [] desirable to increase the pitch to increase the amount of surface area engaging tissue of the wall (para 0120, 0105). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Verzal with the teachings of Morris, because doing so would allow for adjusting the pitch, which provides the predictable result of adjusting the amount of surface area engaging tissue of the wall.
Regarding 11. (Currently Amended) Verzal discloses the system of claim 1, but fails to explicitly disclose wherein the helix tapers from a proximal end of the fixation element to the distal tip.
Morris, from a similar field of endeavor teaches having a fixation member, anchor portion to temporary anchor the device wherein the fixation member have a variety of lengths and helical pitches [] desirable to increase the pitch to increase the amount of surface area engaging tissue of the wall (para 0120, 0105). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Verzal with the teachings of Morris, because doing so would allow for adjusting the pitch, which provides the predictable result of adjusting the amount of surface area engaging tissue of the wall.
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verzal in view of US 20190351218 to Gerber (on IDS).
Regarding 17. (Currently Amended) Verzal discloses the system of claim 1, but fails to disclose wherein the fixation element comprises one or more biocompatible materials.
Gerber from a similar field of endeavor teaches that it is known to use biocompatible material and to select material based upon whether the structure is desired to be rigid, semi-rigid, or flexible properties, which could affect the engagement of the structure to the adjacent material (para 0063). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Verzal with the known teachings of Gerber to provide the predictable result of selecting material that provides the desirable engagement.
Regarding 18. (Original) Verzal as modified by Gerber renders obvious the system of claim 17, wherein the one or more biocompatible materials comprises one or more of platinum, stainless steel, or titanium (Gerber, para 0063).
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796
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