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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 16, 2026 has been entered.
Response to Amendment
The amendment filed July 16, 2026 has been entered. Claims 1, 8, 20 have been amended. Claims 4, 13-19, 23 have been canceled. Currently, claims 1-3, 5-12, 20-22 and 24-27 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 8-12, filed July 16, 2026, with respect to the rejection(s) of claim(s) 1-3, 5-12, 20-22, 24-27 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Swanson et al. (US 2018/0056062).
Claim Interpretation
9. Claim 1 is directed to an apparatus and recites the limitation, “An implantable baroreflex activation therapy system… configured to deliver a baroreflex therapy;… a backer… defining a vessel-facing surface sized and shaped to conform to an outer surface of a blood vessel”. In an apparatus claim, the manner of operating the device does not differentiate the apparatus claim from the prior art. “[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).
10. Claim 8 is directed to a method of manufacturing and recites steps of causing an implantable baroreflex activation therapy system to be manufactured and made available to a user, and providing instructions of implanting the therapy system. Claims 8-12, 20-21 are not directed to the method of implanting baroreflex activation therapy system (which were previously withdrawn, see December 30, 2024 Restriction Requirement and February 28, 2025 Applicant Response). Recited limitations of, “a backer… defining a vessel-facing surface sized and shaped to conform to an outer surface of a blood vessel”, “an expandable coil… being configured to expand… away from the vessel-facing surface” and “making the system available together with instructions recorded on a tangible medium that describe deployment of the electrode structure toward a target site adjacent to a baroreceptor-containing region of the blood vessel… the expandable coil expands… away from the vessel-facing surface to bias against extravascular tissue at the implant location and urge the electrode into contact with the outer surface of the blood vessel” are not actively being recited as a method of implanting in this method of causing an implantable baroreflex activation therapy system to be manufactured and these limitations are not given patentable weight as methods of implanting the implantable baroreflex activation therapy system.
11. Additionally, the limitation of “instructions recorded on a tangible medium that describe deployment of the electrode structure toward a target site adjacent a baroreceptor-containing region of the blood vessel such that, upon release from a delivery sheath, the expandable coil expands in the direction orthogonal to the face of the second side of the backer and away from the vessel-facing surface to bias against extravascular tissue at the implant location and urge the electrode into contact with the outer surface of the blood vessel” is regarded as content of information. This matter does not functionally or structurally relate to the associated physical substrate of the system and is not given patentable weight to printed matter. Id. at 850, 117 USPQ2d at 1268. Where a product merely serves as a support for printed matter, no functional relationship exists. Here, the instructions on a tangible medium merely convey information to the user describing how the product will deploy on its own. There is no new feature of physical structure and no new relation of printed matter to physical structure. See MPEP 2111.05.
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, 3, 5-7, 22, 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 2005/0251238) in view of Swanson et al. (US 2018/0056062) and Rossing et al. (US 2006/0004417).
Regarding claim 1, Wallace et al. discloses an implantable system comprising an electrical lead 214 couplable to a stimulation source ([0057]); and an electrode structure 210 proximate a distal end of the electrical lead 214, the electrode structure including: a backer 212 coupled to the electrical lead and forming a distinct structural element at the distal region of the electrical lead (“The electrode body 212 comprises an arcuate structure 216” [0083]), the backer having a first side and a second side opposite the first side (fig. 19-20), the first side defining a vessel-facing surface sized and shaped to conform to a surface of a blood vessel (“the electrode body 212 can be placed into firm contact with the target site and used to transmit electrical signals to and/or receive electrical signals from the blood vessel” [0082]); an electrode 218 arranged on the first side of the backer, the backer having an effective surface area at least twice an area of the electrode (fig. 20); and an expandable anchor 215 fixed to and carried by the second side of the backer, the anchor having a pre-biased shape-memory configuration (fig. 20) and being configured to expand, upon release from a delivery sheath (“standard stent delivery apparatus” [0082], “delivery catheter 152” [0083]) in a direction orthogonal to a face of the second side of the backer; wherein in an expanded state, the expandable anchor biases against surrounding tissue at an implant location and applies a non-penetrating compressive force through the backer that urges and maintains contact between the electrode and the surface of the blood vessel ([0083]).
The limitation of the electrode being on contact with “an outer surface of a blood vessel” and the expandable coil being configured to expand “away from the vessel-facing surface” and “biases against extravascular tissue” is a matter of intended use. In an apparatus claim, the manner of operating the device does not differentiate the apparatus claim from the prior art. “[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, while the prior art does not expressly disclose the first side of the backer defines a vessel-facing surface sized and shaped to conform to an outer surface of a blood vessel, Wallace et al. states the electrode structure comprising the backer, electrode and expandable loops serve the purpose of stimulating against the blood vessel ([0082]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the dimensions of the backer would also be capable of contacting an outer surface of the blood vessel, and the dimensions of the expandable coil would be capable of expanding away from a vessel-facing surface and biasing against extravascular tissue.
Wallace et al does not expressly disclose the expandable anchor is a coil. Swanson et al. teaches a coil 312 is a known anchor shape in the art for positioning a backer 310 having electrodes 302, 306, 308 against tissue (fig. 3c; [0074]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wallace et al. to try a coil shape as taught by Swanson et al. as it is a known anchor shape for serving the same purpose as the primary art, such a modification involving a mere change in shape of the anchor component. 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).
Wallace et al. does not expressly disclose the implantable system is an implantable baroreflex activation therapy system, comprising: a control system having an implantable housing and configured to deliver a baroreflex therapy, the electrical lead couplable to the control system. Rossing et al. teaches an implantable baroreflex activation therapy system comprising an implantable baroreflex activation therapy system 70, comprising a control system 63 having an implantable housing (fig. 3; [0071]) configured to deliver a baroreflex therapy ([0075-0077]), an electrical lead 72 couplable to the control system (fig. 3). Rossing et al. further teaches an embodiment of the baroreflex activation therapy system being implanted adjacent a blood vessel (fig. 18b) via an expandable coil or braid ([0126]; fig. 13b) to urge electrodes 283, 285 against the vessel wall, which is analogous to the implantation disclosed by Wallace et al. in view of Swanson et al. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wallace et al. to try applying the electrical lead and the electrode structure to an implantable baroreflex activation therapy system with a control system configured to deliver baroreflex therapy, as Rossing et al. indicates baroreflex therapy also requires electrodes to maintain contact with the surface of the blood vessel ([0128]), the results of such a modification being reasonably predictable and would not alter the overall operation of the electrical lead and electrode structure.
Regarding claim 3, Wallace et al. discloses the backer 212 is electrically insulative ([0085]).
Regarding claim 5, Wallace et al. in view of Swanson et al. discloses wherein the expandable coil, in the expanded state, retains the electrode structure in superior and inferior anatomical directions and in anterior and posterior directions to resist migration after implantation ([0074]).
Regarding claim 6, Wallace et al. in view of Swanson et al. discloses the expandable coil is cone-shaped (fig. 3c) in an expanded position and, upon deployment, exerts stabilization forces without penetrating a wall of the blood vessel ([0074]).
Regarding claim 7, Wallace et al. discloses a delivery sheath (“standard stent delivery apparatus”, “delivery catheter 152”) configured to retain the expandable coil in a compressed configuration, the delivery sheath being removable to allow expansion of the coil ([0082-0083]).
Regarding claim 22, Wallace et al. in view of Swanson et al. disclose the expandable coil comprises a plurality of loops or windings that are spaced apart from one another that are capable of permitting soft tissue ingrowth between coil elements following deployment (fig. 3c).
Regarding claim 24, Wallace et al. in view of Swanson et al. disclose the expandable coil is configured to generate a non-radial expansion profile (fig. 3c) upon deployment, resulting in asymmetric contact force across the first side of the backer.
Regarding claim 25, Wallace et al. discloses wherein the backer comprises a shape-retaining material selected to maintain curvature against a pulsating vessel wall after implantation ([0085]).
Regarding claim 26, Wallace et al. in view of Rossing et al. disclose the control system is configured to deliver baroreflex therapy pulses that are modulated based on one or more physiological signals sensed from the patient ([0020]).
Claim(s) 2 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 2005/0251238) in view of Swanson et al. (US 2018/0056062) and Rossing et al. (US 2006/0004417), and further in view of Yu et al. (US 2019/0076655).
Regarding claim 2, Wallace et al. does not expressly disclose wherein the electrode comprises a cathode and the implantable housing includes an anode. Yu et al. discloses an electrical stimulation system wherein the electrode of an implantable lead comprises a cathode and the implantable housing includes an anode ([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 Wallace et al. to designate the electrode as a cathode and the implantable housing as an anode as taught by Yu et al. as it is a known configuration for anodes and cathodes in an implantable medical device system, such a modification would have yielded predictable results.
Regarding claim 27, Wallace et al. does not expressly disclose wherein the control system is configured to interact with an external programmer for data communication and programming of therapy parameters. Yu et al. teaches it is known in the art for a control system of an implantable device to interact with an external programmer 120 for data communication (“therapy history data” [0052])) and programming of therapy parameters ([0051]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wallace et al. to allow for the control system to interact with an external programmer for data communication and programming of therapy parameters as taught by Yu et al. in order to allow for further processing and analysis from a remote location and to allow for reprogramming of the implantable device ([0051]).
Claim(s) 8, 11-12, 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 2005/0251238) in view of Swanson et al. (US 2018/0056062), Rossing et al. (US 2006/0004417) and further in view of Kieval (US 2012/0271137).
Regarding claim 8, Wallace et al. discloses a method, comprising causing an implantable therapy system to be manufactured and made available to a user, the system comprising: an electrical lead 214 couplable to a stimulation source ([0057]); and an electrode structure 210 proximate a distal region of the electrical lead, the electrode structure including: a backer 212 coupled to the electrical lead and forming a distinct structural element at the distal region of the electrical lead (“The electrode body 212 comprises an arcuate structure 216” [0083]), the backer having a first side and a second side opposite the first side (fig. 19-20), the first side defining a vessel-facing surface sized and shaped to conform to a surface of a blood vessel (“the electrode body 212 can be placed into firm contact with the target site and used to transmit electrical signals to and/or receive electrical signals from the blood vessel” [0082]); an electrode 218 arranged on the first side of the backer, the backer having an effective surface area at least twice an area of the electrode; and an expandable anchor 215 fixed to and carried by the second side of the backer (“spring loops 215 can be mounted to the arcuate structure 216 in any suitable manner, including welding or soldering” [0083]), the coil having a pre-biased shape memory configuration and being configured to expand in a direction orthogonal to a face of the second side of the backer (see claim 1) capable of being away from the vessel-facing surface.
Wallace et al does not expressly disclose the expandable anchor is a coil. Swanson et al. teaches a coil 312 is a known anchor shape in the art for positioning a backer 310 having electrodes 302, 306, 308 against tissue (fig. 3c; [0074]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wallace et al. to try a coil shape as taught by Swanson et al. as it is a known anchor shape for serving the same purpose as the primary art, such a modification involving a mere change in shape of the anchor component. 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).
Wallace et al. does not expressly disclose the implantable system is an implantable baroreflex activation therapy system, the system comprising: a control system having an implantable housing. Rossing et al. teaches an implantable baroreflex activation therapy system is manufactured, comprising an implantable baroreflex activation therapy system 70, comprising a control system 63 having an implantable housing (fig. 3; [0071]) configured to deliver a baroreflex therapy ([0075-0077]), an electrical lead 72 couplable to the control system (fig. 3). Rossing et al. further teaches an embodiment of the baroreflex activation therapy system being implanted adjacent a blood vessel (fig. 18b) via an expandable coil or braid ([0126]; fig. 13b) to urge electrodes 283, 285 against the vessel wall, which is analogous to the implantation disclosed by Wallace et al. in view of Swanson et al. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wallace et al. to try applying the electrical lead and the electrode structure to an implantable baroreflex activation therapy system with a control system configured to deliver baroreflex therapy, as Rossing et al. indicates baroreflex therapy also requires electrodes to maintain contact with the surface of the blood vessel ([0128]), the results of such a modification being reasonably predictable and would not alter the overall operation of the electrical lead and electrode structure.
As discussed above, claim 8 is not directed to a method of implanting but merely requires making the system available to a user with instructions that describe implantation. Wallace et al. in view of Swanson et al. and Rossing et al. disclose delivering the electrode structure toward a target site adjacent to a baroreceptor-containing region of the blood vessel (applicant’s own specification states baroreceptors are “profusely distributed within the walls of the major arteries, as well in the heart, aortic arch, carotid sinus or arteries, and in the low-pressure side of the vasculature such as the pulmonary artery and vena cava” ([0006]), such that, upon deployment from a delivery sheath (Wallace [0082]), the coil (Swanson et al.) expands in the orthogonal direction to urge contact between the electrode and the baroreceptor-containing region (Rossing fig. 18b). Wallace et al. does not expressly disclose making the system available together with instructions recorded on a tangible medium that describe deployment of the electrode structure. Kieval teaches it is known in the art for an implantable lead system to be included in a kit with instructions recorded on a tangible medium for implanting the lead ([0049]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wallace et al. to make the system available to the user together with instructions recorded on a tangible medium as taught by Kieval in order to help convey the implantation instructions to a user in a tangible manner, and since it is a technique known in the art and would be reasonably predictable.
The limitation of “instructions recorded on a tangible medium that describe deployment of the electrode structure toward a target site adjacent a baroreceptor-containing region of the blood vessel such that, upon release from a delivery sheath, the expandable coil expands in the direction orthogonal to the face of the second side of the backer and away from the vessel-facing surface to bias against extravascular tissue at the implant location and urge the electrode into contact with the outer surface of the blood vessel” is regarded as content of information. This matter does not functionally or structurally relate to the associated physical substrate of the system and is not given patentable weight to printed matter. Id. at 850, 117 USPQ2d at 1268. Where a product merely serves as a support for printed matter, no functional relationship exists. Here, the instructions on a tangible medium merely convey information to the user describing how the product will deploy on its own. There is no new feature of physical structure and no new relation of printed matter to physical structure. See MPEP 2111.05.
Regarding claim 11, Wallace et al. in view of Rossing et al. disclose wherein the blood vessel is selected from the group consisting of: a carotid sinus, an aortic arch, a common carotid artery, a subclavian artery, a brachiocephalic artery, and a heart ([0013]).
Regarding claim 12, Wallace et al. in view of Swanson et al. disclose wherein the expandable coil is cone-shaped (fig. 3c) and configured, upon deployment, to retain the electrode structure in the superior and inferior anatomical directions and in the anterior and posterior anatomical directions without penetrating the vessel wall ([0072]).
Regarding claim 20, Wallace et al. in view of Swanson et al. discloses releasing the electrode structure from the delivery sheath 155 such that the expandable coil transitions from a compressed configuration to its pre-biased shape memory configuration (fig. 3c) and expands in the direction orthogonal to the face of the second side of the backer to bias against surrounding tissue at the implant location and maintain contact of the electrode with the outer surface of the blood vessel ([0072]).
Regarding claim 21, Wallace et al. discloses the expandable coil is formed from a shape memory material that assumes its expanded configuration upon exiting the delivery sheath in vivo ([0082-0083]).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 2005/0251238) in view of Swanson et al. (US 2018/0056062), Rossing et al. (US 2006/0004417) and Kieval (US 2012/0271137) and further in view of Cates et al. (US 2012/0109250).
Regarding claim 9, Wallace et al. does not expressly disclose the instructions further describe positioning the first side of the backer in contact with the outer surface of the blood vessel. Cates et al. teaches positioning the first side of the backer in contact with an outer surface of the blood vessel 40 is known in the art as a stimulation site ([0057]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wallace et al. to include instructions to try securing the first side of the backer with the outer surface of a blood vessel as Cates et al. teaches this is a known attachment site for stimulation.
Regarding claim 10, Wallace et al. does not expressly disclose determining a suitable implant location for the electrode structure on the blood vessel prior to securing the electrode structure at the target site. Cates et al. teaches determining a suitable implant location for the electrode structure of the blood vessel prior to securing the electrode structure at the implant location via ultrasound or imaging techniques ([0059]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wallace et al. to determine a suitable implant location for the electrode structure on the blood vessel prior to securing the electrode structure at the target site as taught by Cates et al. in order to better plan for the implantation procedure in advance.
Conclusion
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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