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 .
Response to Amendment
The amendment filed July 28, 2026 has been entered. Claims 1, 8-11, 14-19 have been amended. Claims 2-7, 12-13, 20 have been amended. Claims 21-23 are new. Currently, claims 1, 8-11, 14-19 and 21-23 are pending for examination.
Response to Arguments
Applicant's arguments filed July 28, 2026 have been fully considered but they are not persuasive to overcome the prior art. Applicant argues Verzal et al. (WO 2021/242633) does not disclose the claimed invention because it requires, “the first stimulation element, the second stimulation element, and the flexible connector segment are configured to each be chronically implantable via a first implant-access incision in a submental region of a patient’s body with [a] flexible connector segment configured to straddle a sagittal midline in the submental region, with the first implant-access incision at least partially overlapping with the sagittal midline in the submental region” and the prior art do not disclose these components to each be implanted via a first implant-access incision which is at least partially overlapping with the sagittal midline in the submental region (p. 10-13). The location of implantation for the first stimulation element, the second stimulation element and the flexible connector segment is regarded as a manner of operating the device. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).
Applicant further argues the prior art does not disclose claim 1’s limitation of: (1) the first stimulation element configured to be positionable in stimulating relation to a first hypoglossal nerve portion on a first side of a body of a patient; (2) the second stimulating element configured to be positionable in stimulating relation to a second hypoglossal nerve portion on a second side of the body which is opposite the first side; (3) a flexible connector segment including a first end and an opposite second end, wherein the distal portion of the lead body is connected to the flexible connector segment at an intermediate portion between the first and second ends of the flexible connector segment; (4) wherein the flexible connector segment extends directly between the first stimulation element and the second stimulation element; (5) the flexible connector segment configured to straddle a sagittal midline in the submental region. With respect to limitations (1), (2), (5), as stated above, the location of implantation for the first stimulation element, the second stimulation element and the flexible connector segment is regarded as a manner of operating the device and intended use. Claim 1 is directed to an apparatus claim, and “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). With respect to limitation (3), the structure claimed reads on Verzal et al. for at least Figure 14L, where distal lead portions 3420, 3422 are interpreted as the flexible connector segment including a first end and an opposite second end, and distal portion of lead body 3410 is connected to the flexible connector segment at an intermediate portion junction 3418 between the first and second ends of the flexible connector segment. Along these lines, limitation (4) is disclosed by Figure 14L, wherein the flexible connector segment 3420, 3422 extends directly between first stimulation element 6310A and second stimulation element 6310B. While applicant argues against Figure 14L on page 16, nothing is currently recited in claim 1 that prevents the interpretation of the combination of distal lead portions 3420 and 3422 to be interpreted as the flexible connector segment in the manner described above.
Applicant argues the rejections of claim 8 and 16 reciting the same arguments as claim 1 and are therefore unpersuasive for the same reasons above.
Applicant’s arguments directed to claims 18 and 19 are moot in view of the interpretation of the embodiment of Figure 14L of Verzal et al. teaching the limitations required by independent claim 16.
Claim Objections
Claim 1 is objected to because of the following informalities: line 17 should state, “wherein at least the first stimulation element, the second stimulation element,”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 references the limitation "wherein being independent positionable" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 for which claim 9 now directly depends, does not recite any limitations directed to anything being “independent positionable”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 8, 11 and 23 is/are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by Verzal et al. (WO 2021/242633).
Regarding claim 8, Verzal et al. discloses a device (fig. 14L) comprising: a proximal lead portion 3410 connectable to an implantable pulse generator 533; a first distal lead segment 3420 extending from a bifurcation portion 3418 of the proximal lead portion and including a first stimulation element 6310A, the first stimulation element comprising a first carrier body supporting a plurality of spaced apart electrodes (“the stimulation portions 6310A, 6310B may comprise a linear array of spaced apart electrodes” [00218]); and a second distal lead segment 3422 extending from the bifurcation portion 3418 of the proximal lead portion and including a second stimulation element 6310B, the second stimulation element comprising a second carrier body supporting a plurality of spaced apart electrodes ([00218]), wherein the first distal lead segment, and the second distal lead segment configured to be independently positionable relative to each other (fig. 14L).
The limitations directed to the first stimulation element configured to be positionable into stimulating relation to a first hypoglossal nerve portion on a first side of a body of a patient; the second stimulation element configured to be positionable into stimulating relation to a second hypoglossal nerve portion on a second side of the body of the patient which is opposite the first side; and wherein at least the first distal lead segment, the second distal lead segment, and the bifurcation portion of the proximal lead portion are configured to be chronically implanted via a first implant-access incision in a submental region of a patient’s body and with at least one of the respective first and second distal lead segments configured to straddle the sagittal midline are regarded as a manner of operating the device and intended use. Claim 8 is directed to an apparatus claim, and “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Additionally, one of ordinary skill in the art would acknowledge the length and flexibility of the first and second distal lead segments 3420, 3422 would be capable of being positioned in stimulating relation to a first hypoglossal nerve portion and a second hypoglossal nerve portion in the manner claimed, and given the prior art discloses an implant-access incision 609E located near the implant area ([0218], fig. 14L), that each of the first distal lead segment, the second distal lead segment, and the bifurcation portion of the proximal lead portion would be capable of being chronically implanted via a first implant-access incision in the submental region of a patient’s body, with the flexible connector segment straddling a sagittal midline in the submental region, with at least one of the respective first and second distal lead segments configured to straddle the sagittal midline. The limitation of, wherein the first implant access incision at least partially overlaps with a sagittal midline in the submental region, is not given patentable weight as it does not further limit the structure of the device.
Regarding claim 11, Verzal et al. discloses first and second stimulation elements 6310A,B which each are connected to their respective first and second distal lead segments, are placed in different stimulating regions of the body ([00217-00222], fig. 14L), therefore regarded as each of the first and second stimulation elements being independently positionable in a selectable orientation, according to at least one of: three rotational degrees of freedom including a roll parameter, a yaw parameter, and a pitch parameter; or three translational degrees of freedom.
Regarding claim 23, Verzal et al. discloses wherein each of the respective first and second stimulation elements comprise anchor elements (“As further noted elsewhere, each stimulation portion 6310A, 631 OB and supporting distal lead portion 3420, 3422 (respectively) may comprise anchor element(s) as described in various examples of the present disclosure, such as but not limited to those in FIGS. 30B-32B.” [00222]) configured to anchor to patient anatomy to maintain the stimulating relation relative to target tissues, including the first and second hypoglossal nerve portions ([00222]), wherein the respective anchor elements are located on, and provide substantially continuous coverage on an outer surface of the respective first and second stimulation elements (fig. 30B-32B), wherein the substantially continuous coverage comprises the anchor elements covering at least about 50 percent of the total surface area of the outer surface of the respective first and second stimulation elements (“It will be understood that in some examples, the elements 6924 may extend about an entire periphery (e.g. circumference of body 6713)” [00349]); and wherein the plurality of anchor elements comprise heterogeneous anchor elements, wherein at least a majority of the anchor elements comprise at least one of a different size, different shape, different position, and different orientation relative to each other (fig. 30B-32B; [00307-00398]).
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.
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.
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) 1, 9-10, 14-19, 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verzal et al. (WO 2021/242633).
Regarding claim 1, Verzal et al. discloses a device (fig. 14L) comprising: a lead body 3410 including a distal portion and an opposite proximal portion connectable to an implantable pulse generator 533; a flexible connector segment 3420, 3422 including a first end and an opposite second end, wherein the distal portion of the lead body is connected to the flexible connector segment at an intermediate portion 3418 between the first and second ends of the flexible connector segment; a first stimulation element 6310A extending from the first end of the flexible connector segment; and a second stimulation element 6310B extending from the second end of the flexible connector segment, wherein the flexible connector segment 3420, 3422 extends directly between the first stimulation element and the second stimulation element (fig. 14L).
The limitations directed to the first stimulation element configured to be positionable into stimulating relation to a first hypoglossal nerve portion on a first side of a body of a patient; the second stimulation element configured to be positionable into stimulating relation toa second hypoglossal nerve portion on a second side of the body of the patient which is opposite the first side; and wherein at least the first stimulation element, the second stimulation element, and the flexible connector segment are each configured to be chronically implantable via a first implant-access incision in a submental region of a patient’s body with the flexible connector segment configured to straddle a sagittal midline in the submental region are regarded as a manner of operating the device and intended use. Claim 1 is directed to an apparatus claim, and “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Additionally, one of ordinary skill in the art would acknowledge the length and flexibility of the flexible connector segment 3420, 3422 would be capable of positioning the first stimulation element and the second stimulation element on first and second sides of a body of a patient in the manner claimed, and given the prior art discloses an implant-access incision 609E located near the implant area ([00218], fig. 14L), that each of the first stimulation element, second stimulation element, and flexible connector segment would be capable of being chronically implantable via a first implant-access incision in the submental region of a patient’s body, with the flexible connector segment straddling a sagittal midline in the submental region, with the first implant-access incision at least partially overlapping with the sagittal midline in the submental region. The limitation of, the first implant-access incision at least partially overlapping with the sagittal midline in the submental region, is not given patentable weight as it does not further limit the structure of the device.
Verzal et al. does not expressly disclose wherein each of the respective first and second stimulation elements comprise a paddle-style carrier body supporting a plurality of spaced apart electrodes. However Verzal et al. lists paddle-style carrier bodies as a known type of stimulation elements ([0081], [0099], [00108]), these paddle-style carrier bodies supporting a plurality of spaced apart electrodes (fig. 14P, 24A-B, 27A-B, 28). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the stimulation elements 6310A,B with a paddle-style carrier body supporting a plurality of spaced apart electrodes as Verzal et al. teaches it is “well understood in the art” that these stimulation elements “may comprise other types of electrode configurations (e.g. cuff, paddle, etc.)” ([0099]), the results of such a modification being predictable.
Regarding claim 9, Verzal et al. discloses first and second stimulation elements 6310A,B which each are connected to their respective flexible connector segment ends, are placed in different stimulating regions of the body ([00217-00222], fig. 14L), therefore regarded as comprising at least a proximal end of the respective first and second stimulation elements having at least two degrees of freedom of movement relative to each other.
Regarding claim 10, the limitation of, the first and second hypoglossal nerve portions comprise at least one of: a protrusor-related nerve portion; or at least one neuromuscular junction of the at least one genioglossus muscle portion and the first and second hypoglossal nerve portions, is not given patentable weight as it does not further limit the structure of the device.
Regarding claim 14, Verzal et al. discloses wherein the flexible connector segment 3420, 3422 comprises an elongate, non-planar member ([00218]), and wherein the first and second stimulation elements are configured to be implantable by varying a distance between a proximal end of the first stimulation element and a proximal end of the second stimulation element via manipulation of a shape of the flexible connector segment via one or more bends along a length of the flexible connector segment (fig. 14L) but does not expressly disclose comprising a greatest cross-sectional dimension substantially smaller than a greatest cross-sectional dimension of each respective paddle-style carrier body. However it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a size of the flexible connector segment or each respective paddle-style carrier body such that a greatest cross-sectional dimension is substantially smaller than a greatest cross-sectional dimension of each respective paddle-style carrier body since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 15, Verzal et al. discloses first and second stimulation elements 6310A,B which each are connected to their respective flexible connector segment ends, are placed in different stimulating regions of the body ([00217-00222], fig. 14L), therefore regarded as each of the first and second stimulation elements configured to be independently positionable in a selectable orientation, according to at least one of: three rotational degrees of freedom including a roll parameter, a yaw parameter, and a pitch parameter; or three translational degrees of freedom.
Regarding claim 16, Verzal et al. discloses a device (fig. 14L) comprising: a lead body 3410 including a distal end and an opposite proximal end connectable to an implantable pulse generator 533; a single, elongate carrier body including: a first stimulation element 6310A comprising a first arm including a plurality of spaced apart electrodes ([00218]); a second stimulation element 6310B comprising a second arm including a plurality of spaced apart electrodes ([00218]); and a common portion 3420, 3422 interposed between the respective first and second arms and being electrode-free, wherein the common portion is connected to, and extends from, the distal end of the lead body (fig. 14L).
The limitation directed to, wherein the single, elongate carrier body is configured to be chronically implanted via a first implant-access incision in a submental region of a patient’s body at least partially overlapping with a sagittal midline in the submental region, with the common portion configured to straddle the sagittal midline, is regarded as a manner of operating the device and intended use. Claim 16 is directed to an apparatus claim, and “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Additionally, one of ordinary skill in the art would acknowledge that given the prior art discloses an implant-access incision 609E located near the implant area ([00218], fig. 14L), that the single, elongate carrier body would be capable of being chronically implanted via a first implant-access incision in the submental region of a patient’s body at least partially overlapping with the sagittal midline in the submental region, with the common portion capable of straddling the sagittal midline.
Verzal et al. does not expressly disclose the first arm is a first paddle-style arm including a plurality of spaced apart electrodes, and the second arm is a second paddle-style arm including a plurality of spaced apart electrodes. However Verzal et al. lists paddle-style carrier bodies as a known type of stimulation element ([0081], [0099], [00108]), these paddle-style carrier bodies supporting a plurality of spaced apart electrodes (fig. 14P, 24A-B, 27A-B, 28). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the stimulation elements 6310A,B with a paddle-style arm supporting a plurality of spaced apart electrodes as Verzal et al. teaches it is “well understood in the art” that these stimulation elements “may comprise other types of electrode configurations (e.g. cuff, paddle, etc.)” ([0099]), the results of such a modification being predictable.
Regarding claim 17, Verzal et al. discloses wherein the single, elongate carrier body comprises a substantially uniform cross-sectional size, a substantially uniform cross-sectional shape, and a length to position the common portion to straddle the sagittal midline of the patient’s body (fig. 14L) but it would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single, elongate carrier body to select a substantially unform cross-sectional size, cross-sectional shape, and a sufficient length since such a modification would have involved a mere change in the size of a component or change in form or shape of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 18, Verzal et al. discloses a control portion (“stimulation device”) configured to deliver control signals to deliver stimulation via the first and second stimulation elements (“The stimulation device 3405 is adapted for providing bilateral stimulation” [00218]) across a sagittal midline 3401 of the patient’s body as at least one first vector between at least one electrode of the first stimulation element 6310A on the first side of the patient’s body and at least one electrode of the second stimulation element 6310B on the second side of the patient’s body (fig. 14L).
Regarding claims 19 and 21, Verzal et al. discloses wherein each of the respective first and second stimulation elements comprise anchor elements (“As further noted elsewhere, each stimulation portion 6310A, 631 OB and supporting distal lead portion 3420, 3422 (respectively) may comprise anchor element(s) as described in various examples of the present disclosure, such as but not limited to those in FIGS. 30B-32B.” [00222]) configured to anchor to patient anatomy to maintain the stimulating relation relative to target tissues, including the first and second hypoglossal nerve portions ([00222]), wherein the respective anchor elements are located on, and provide substantially continuous coverage on an outer surface of the respective first and second stimulation elements (fig. 30B-32B), wherein the substantially continuous coverage comprises the anchor elements covering at least about 50 percent of the total surface area of the outer surface of the respective first and second stimulation elements (“It will be understood that in some examples, the elements 6924 may extend about an entire periphery (e.g. circumference of body 6713)” [00349]); and wherein the plurality of anchor elements comprise heterogeneous anchor elements, wherein at least a majority of the anchor elements comprise at least one of a different size, different shape, different position, and different orientation relative to each other (fig. 30B-32B; [00307-00398]).
Regarding claim 22, Verzal et al. discloses wherein the distal portion of the lead body and the intermediate portion of the flexible connector segment form a T-shaped junction 3418 (fig. 14L; E.N. “T-shaped junction” regarded as a bifurcated junction).
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 ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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