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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02 Jan 2026 has been entered.
This Office Action is responsive to the amendment filed on 02 Jan 2026. As directed by the amendment: claims 1-4, 7-11, 13, 16-17, and 31-32 have been amended, claims 5-6, 12, 15, 19-20, and 26-30 have been canceled, and claims 31-42 have been added. Thus, claims 1-4, 7-11, 13-14, 16-18, 21-25, and 31-42 are presently pending in this application.
Response to Arguments
Claim Rejections-35 U.S.C. §112(b)
Applicant’s arguments, see Remarks, filed 02 Jan 2026, with respect to the rejections of claims 4 and 31 under 35 U.S.C. 112(b) have been fully considered and are persuasive in light of the claim amendments. The rejections of claims 4 and 31 under 35 U.S.C. 112(b) have been withdrawn.
However, new rejections under 35 U.S.C. 112(b) are made below, as necessitated by the claim amendments.
Claim Rejections-35 U.S.C. §103
Applicant’s arguments, see Remarks, filed 02 Jan 2026, with respect to the rejection of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Brunnett et al. (US 20100145221 A1, previously cited), hereinafter Brunnett, and Imran et al. (US 20080140152 A1), hereinafter Imran.
No specific arguments regarding dependent claims 2-4, 7-11, 13-14, 16-18, 21-25, and 31-42 and the previously cited prior art references were made. Therefore claims 2-4, 7-11, 13-14, 16-18, 21-25, and 31-42 are rejected below.
Claim Objections
Claims 4 and 37 are objected to because of the following informalities:
Claim 4: “and” should be added after the comma in line 3
Claim 37: a period should be added at the end of the claim
Appropriate correction is required.
Claim Interpretation
The term “connecting tissue” in claim 1, is not specifically defined in the claim. The specification discloses the following (emphasis added):
[0064] A blood vessel (e.g., artery or vein) can include intimal tissues (e.g., endothelium, basement membrane, stratum subendothelial, internal clastic membrane), medial tissues (e.g., smooth muscle, collagen), and adventitial tissues (e.g., external elastic membrane, serosa, nerves, blood vessels). These tissues can be surrounded by periadventitial and/or other outermost connecting tissues.
[0090] For example, as described in more detail with reference to FIG. 7, identifying the target region can include identifying a circumference of the connecting tissue of the ICA expected to include the CSN and/or one or more fibers associated with the baroreceptors. The circumference expected to include the CSN can be noted by the physician when identifying the longitudinal axis along the length of the ICA used to create the openings for positioning the patient treatment system, as described in more detail below. In some embodiments, the target region includes the entirety of the connecting tissue between the ICA and an external carotid artery (ECA) of the patient such that the signal delivery device can be positioned to envelop both the tissue surrounding and/or between the ICA and the ECA.
[0091] At block 1404, the method 1400 can include forming, at a first area of the target region, a first opening along the longitudinal axis through the outermost connecting tissue of the ICA. The process for forming an opening at the first area of the target region can be identical or generally similar to the process of forming an opening at a side of the target region, as described in more detail with reference to blocks 704 and 1304 of FIGS. 7 and 13, respectively. In some embodiments, the first opening separates the connecting tissue that includes the CSN and/or fibers associated with the baroreceptors from the ICA at the first area of the target region.
[0092] At block 1406, the method 1400 can include forming, at a second area of the target region, a second opening along the longitudinal axis through the outermost connecting tissue. The process for forming the second opening at the second area of the target region can be identical or generally similar to the process of forming the first opening at the first area of the target region, as described in more detail with reference to block 1404. In some embodiments, the second opening at least partially separates the connecting tissue from the ICA at the second opening. As described at block 1402, when identifying the longitudinal axis along the length of the ICA, a circumference expected to include the CSN can be identified. The circumference expected to include the CSN can be used to identify the first and second areas of the target region and thus the position of the first and second openings. For example, the second opening can be spaced circumferentially apart from the first opening. Additionally or alternatively, the first opening and the second opening can define opposing ends of a tunnel extending between the connecting tissue and the ICA used to position the patient treatment system described herein. In some embodiments, the method 1400 further includes identifying the ECA in the target area of the patient and a second longitudinal axis extending along the length of the ECA for forming an opening. The method 1400 can also include forming an opening (e.g., a second or third opening) along the second longitudinal axis through the connecting tissue (e.g., the innermost and outermost tissue) of the ECA and extending this opening to an opening along the ICA (e.g., the first or second openings described above).
[0093] At block 1408, the method 1400 can include positioning a first region of a signal delivery device through a tunnel (e.g., the tunnel extending between the connecting tissue and the ICA described in more detail with reference to block 1406) such that an end of the first region of the signal delivery device is adjacent to or extends laterally beyond the second opening.
From claim 1 and the specification, the term “connecting tissue” can be broadly interpreted as “tissue that surrounds a blood vessel” or “periadventitial tissue” (paragraph [0064]). “Periadventitial tissue” has a similar definition of tissue that is “Situated or occurring outside the tunica adventitia of a blood vessel” (Oxford English Dictionary, “periadventitial (adj.),” March 2026, https://doi.org/10.1093/OED/4268682764).
Therefore, “connecting tissue” can include any tissue that is found outside of a blood vessel, which includes nerves that lie outside of a blood vessel.
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.
Claims 16-17, 21 and 38-39 are 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 16 recites the limitation "the one of the at least one first electrode and the at least second electrode" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites “a first electrical signal” in line 3, and “the electrical signal” in line 6. It is unclear as to whether the patient response is to the electrical signal (established in claim 1) or to the first electrical signal (established in line 3). For the purposes of examination, “the electrical signal” in line 6 will be interpreted as “the first electrical signal”.
Thus, for clarity, claim 16 will be interpreted as follows:
The method of claim 1, further comprising:
selecting a first electrode to deliver a first electrical signal to the patient, the first electrode being selected from the at least one first electrode and the at least one second electrode of the signal delivery device;
delivering the first electrical signal via the first electrode;
determining that a patient response to the first electrical signal is less than a response threshold; and
after determining the patient response, delivering a second electrical signal via a second electrode, the second electrode being selected from the at least one first electrode and the at least one second electrode of the signal delivery device, the second electrode being a different electrode than the first electrode.
Claim 17 recites the limitation "the patient response to the second electrical signal" in line 2, and “the other different one of the at least one first electrode and the at least second electrode” in lines 4-5. There is insufficient antecedent basis for these limitations in the claim.
Thus, for clarity, claim 17 will be interpreted as follows:
The method of claim 16, further comprising:
determining that a patient response to the second electrical signal is equal to or greater than the response threshold; and
delivering a therapy signal to the patient via the second electrode.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 21 recites the broad recitation “less than…10%”, and the claim also recites “less than 5%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 38 recites the limitation "the CSN" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 39 recites the limitation "the vagus nerve" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 3-4, 8, 10, 23-24, and 36-39 are rejected under 35 U.S.C. 103 as being unpatentable over Brunnett et al. (US 20100145221 A1, previously cited), hereinafter Brunnett, in view of Imran et al. (US 20080140152 A1), hereinafter Imran.
Regarding claim 1, Brunnett discloses a method of implanting a signal delivery device to deliver an electrical signal to a patient, the method comprising:
identifying a target region of a blood vessel (Fig. 14, paragraph [0143], surrounding tissues 512, 514 (such as the internal jugular vein and the common carotid artery)) of the patient expected to include baroreceptor afferent nerve fibers (Fig. 14, paragraph [0143], target nerve 510 (e.g., vagus nerve));
forming an opening at the target region to partially separate periadventitial tissue surrounding the blood vessel from the blood vessel, wherein the separated periadventitial tissue includes the baroreceptor afferent nerve fibers of the patient (Fig. 14, paragraph [0143], "After making an incision in sheath 502, nerve-engaging portion 417 is introduced and advanced within an interior space contained via sheath 502 until the recess portion 420 releasably engages target nerve 510 and until the fingers 416, 418 separate target nerve 510 from each of a first surrounding tissue 512 (e.g., a common carotid artery) and a second surrounding tissue 514 (e.g., an internal jugular vein).");
positioning a first region of the signal delivery device (Fig. 14, finger 416) at least partially through the opening such that the first region is between the blood vessel and the baroreceptor afferent nerve fibers of the separated periadventitial tissue (Fig. 14, paragraph [0143], "fingers 416, 418 separate target nerve 510 from each of a first surrounding tissue 512 (e.g., a common carotid artery) and a second surrounding tissue 514 (e.g., an internal jugular vein)"); and
positioning a second region of the signal delivery device (Fig. 14, finger 418) at least partially over the first region such that
(i) the connecting tissue of the separated periadventitial tissue is between the first region and the second region (Fig. 14, paragraph [0143], nerve-engaging portion 417 is between fingers 416, 418) and
(ii) at least one first electrode faces toward the baroreceptor afferent nerve fibers of the periadventitial tissue (Fig. 13, paragraph [0136], "this arrangement provides a recess portion 420 between the respective fingers 416, 418 wherein the recess portion 420 is configured to slidably engage an outer surface of the target nerve, which in turn, brings an electrode contact 440 into secure engagement in electrical conduction with the outer surface of the target nerve").
Brunnett does not explicitly disclose that the first and second regions of the signal delivery device include at least one first electrode and at least one second electrode, respectively.
However, Imran teaches devices, systems and methods for stimulation of tissues and structures within a body of a patient (paragraph [0014]). Imran teaches a signal delivery device (Fig. 19, paragraph [0080], shaped flexible circuit lead 500) comprising a first region (lead 100a) and a second region (lead 100b), each region including at least one electrode (paragraph [0080], "The shaped lead 500 is comprised of two individual leads 100a, 100b, each having at least one electrode 106").
Imran further teaches positioning the first region and the second region around a target tissue area that includes a target nerve so that the at least one first electrode and the at least one second electrode face toward the target tissue area (Fig. 20, paragraph [0081]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brunnett with the teachings of Imran so that the first and second regions of the signal delivery device include at least one first electrode and at least one second electrode, respectively, because doing so provides a higher likelihood of stimulating the target nerve (Imran, paragraph [0081]).
Regarding claim 3, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Brunnett further discloses that the at least one electrode is positioned directly over at least one of the baroreceptor afferent nerve fibers (Fig. 14, paragraph [0143], "engaging electrode 400 against a target nerve 510"). Imran also further teaches that positioning the second region at least partially over the first region includes positioning the second region directly over at least one of the nerve fibers (Fig. 20, paragraph [0081], "the lead 500 is positioned so the target tissue area resides between at least a portion of the electrodes 106 along the mouth of the V").
Regarding claim 4, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Brunnett does not explicitly disclose that the at least one first electrode comprises two or more first electrodes, and the at least one second electrode comprises two or more second electrodes.
However, Imran further teaches that:
the at least one first electrode comprises two or more first electrodes (Fig. 19, paragraph [0080], electrodes 106 on lead 100a),
the at least one second electrode comprises two or more second electrodes (Fig. 19, paragraph [0080], electrodes 106 on lead 100b).
Regarding claim 8, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Brunnett further discloses that forming the opening includes separating the periadventitial tissue from adventitial, medial, and/or intimal tissues surrounding the blood vessel of the patient (Fig. 14, paragraph [0143], "fingers 416, 418 separate target nerve 510 from each of a first surrounding tissue 512 (e.g., a common carotid artery) and a second surrounding tissue 514 (e.g., an internal jugular vein)", wherein target nerve 510 is analogous to the periadventitial tissue and surrounding tissues 512, 514 are analogous to the blood vessel).
Regarding claim 10, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Brunnett further discloses that forming the opening includes forming a tunnel between a first side of the target region and a second side of the target region spaced apart from the first side (Fig. 14, paragraph [0143], "nerve-engaging portion 417 is introduced and advanced within an interior space contained via sheath 502").
Regarding claim 23, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Brunnett does not explicitly disclose that positioning the second region at least partially over the first region includes folding the second region at least partially over the first region.
However, Imran further teaches that positioning the second region at least partially over the first region includes folding the second region at least partially over the first region (Fig. 20, paragraph [0080], "Lead 100a is folded to form a crease 502a along its length between the electrodes 106 and the contact pads 108 so that an acute angle .alpha. is formed between the back of the distal end (opposite the electrodes 106) and the face of the proximal end 104 having the contact pads 108 thereon. Likewise, lead 100b is folded to form a crease 502b along its length between the electrodes 106 and the contact pads 108 so that an acute angle .beta. is formed between the back of the distal end (opposite the electrodes 106) and the face of the proximal end 104 having the contact pads 108 thereon").
Regarding claim 24, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Brunnett further discloses that the first region and the second region include respective ends that are coupled to a third region of the signal delivery device (Figs. 12-13, paragraph [0141], fingers 416, 418 are attached to proximal region 433). Brunnett does not explicitly disclose that positioning the second region at least partially over the first region includes moving the second region relative to the first region about the third region.
However, Imran further teaches that the first region and the second region include respective ends that are coupled to a third region of the signal delivery device (Figs. 19-20, paragraph [0080], creases 502a and 502b are at the proximal ends of leads 100a and 100b, respectively), and wherein positioning the second region at least partially over the first region includes moving the second region relative to the first region about the third region (paragraph [0080], "Lead 100a is folded to form a crease 502a along its length between the electrodes 106 and the contact pads 108 so that an acute angle .alpha. is formed between the back of the distal end (opposite the electrodes 106) and the face of the proximal end 104 having the contact pads 108 thereon. Likewise, lead 100b is folded to form a crease 502b along its length between the electrodes 106 and the contact pads 108 so that an acute angle .beta. is formed between the back of the distal end (opposite the electrodes 106) and the face of the proximal end 104 having the contact pads 108 thereon").
Regarding claim 36, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Brunnett further discloses that the baroreceptor afferent nerve fibers are contained within the connecting tissue of the periadventitial tissue (Fig. 14, paragraph [0143], target nerve 510 is contained within sheath 502).
Regarding claim 37, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Brunnett further discloses that the baroreceptor afferent nerve fibers are associated with one or more branches of a vagus nerve of the patient (paragraph [0143], target nerve 510 can be a vagus nerve).
Regarding claim 38, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Brunnett further discloses that the baroreceptor afferent nerve fibers are associated with one or more branches of the CSN of the patient (paragraph [0143], target nerve 510 can be a vagus nerve, which communicates with the CSN (see Gray, page 909).
Regarding claim 39, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Brunnett further discloses that the baroreceptor afferent nerve fibers are associated with one or more branches of a vagus nerve of the patient (paragraph [0143], target nerve 510 can be a vagus nerve).
Claims 2, 7, 33, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Brunnett et al. (US 20100145221 A1, previously cited), hereinafter Brunnett, in view of Imran et al. (US 20080140152 A1), hereinafter Imran, and further in view of Lerner (US 20180104491 A1, previously cited).
Regarding claim 2, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Although Brunnett further discloses that the nerve fibers are located adjacent to a common carotid artery (paragraph [0143]), and that the target nerve can comprise a different nerve not located within the carotid sheath (paragraph [0135]), Brunnett does not explicitly disclose that the blood vessel is an internal carotid artery (ICA) and the baroreceptor afferent nerve fibers extend alongside or adjacent the ICA.
However, Lerner teaches an implantable electronic neuromodulation system (Abstract) for stimulating the carotid sinus nerve (paragraph [0025], the carotid sinus nerve extends alongside the ICA).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brunnett and Imran with the teachings of Lerner so that the blood vessel is an internal carotid artery (ICA) and the baroreceptor afferent nerve fibers extend alongside of adjacent the ICA, because stimulation of the carotid sinus reduces heart rate and blood pressure (Lerner, paragraph [0025]).
Regarding claim 33, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Although Brunnett further discloses that the target nerve can comprise a different nerve not located within the carotid sheath (paragraph [0135]), Brunnett does not explicitly disclose that the target region is located superior to a carotid sinus of the patient.
However, Lerner teaches an implantable electronic neuromodulation system (Abstract) for stimulating the carotid sinus nerve (paragraph [0025]), which is superior to the carotid sinus (see Hering et al., "Novel approaches: targeting sympathetic outflow in the carotid sinus", Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brunnett and Imran with the teachings of Lerner to identify a target region superior to a carotid sinus of the patient, because stimulation of the carotid sinus reduces heart rate and blood pressure (Lerner, paragraph [0025]).
Regarding claim 7, the method of claim 33 is obvious over Brunnett, Imran, and Lerner, as explained above. Lerner further teaches stimulating the carotid sinus nerve (paragraph [0025]), which is superior to the carotid sinus (see Hering et al., "Novel approaches: targeting sympathetic outflow in the carotid sinus", Fig. 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to identify a target region no more than 2 cm superior to the carotid sinus of the patient, for the purpose of optimizing the effectiveness of the stimulation, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 41, the method of claim 2 is obvious over Brunnett, Imran, and Lerner, as explained above. Lerner further teaches that identifying the target region comprises identifying a portion of a circumference of the ICA (paragraph [0025], the carotid sinus nerve extends alongside the ICA).
Claims 9, 11, 31, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Brunnett et al. (US 20100145221 A1, previously cited), hereinafter Brunnett, in view of Imran et al. (US 20080140152 A1), hereinafter Imran, and further in view of Christopherson et al. (US 20120089153 A1, previously cited), hereinafter Christopherson.
Regarding claim 9, the method of claim 10 is obvious over Brunnett and Imran, as explained above. Brunnett does not explicitly disclose that forming the opening includes making a first cut at the first side of the target region and a second cut at the second side of the target region spaced apart from the first side, and wherein the opening between the first cut and the second cut defines the tunnel.
However, Christopherson teaches a method for percutaneously implanting a stimulation lead (Abstract), comprising making a first cut at the first side of the target region and a second cut at the second side of the target region spaced apart from the first side, and wherein the opening between the first cut and the second cut defines the tunnel (Fig. 30, paragraph [0153], incisions 880, 882; the tunnel is defined by the space that electrode strip 815 must travel through).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brunnett and Imran with the teachings of Christopherson so that forming the opening includes making a first cut at the first side of the target region and a second cut at the second side of the target region spaced apart from the first side, and wherein the opening between the first cut and the second cut defines the tunnel, because doing so has a minimal mechanical impact on the nerve and the surrounding tissues (Christopherson, paragraph [0122]).
Regarding claim 11, the method of claim 10 is obvious over Brunnett, Imran, and Christopherson, as explained above. Brunnett further discloses that the connecting tissue of the separated periadventitial tissue remains attached to the blood vessel except at the tunnel between the first side of the target region and the second side of the target region (Fig. 14, paragraph [0143]).
Regarding claim 31, the method of claim 9 is obvious over Brunnett, Imran, and Christopherson, as explained above. Christopherson further teaches that the tunnel has a width that is no more than 10 millimeters (paragraph [0153], "In particular, because the electrode strip 815 is quite narrow (e.g., 3 millimeters wide as shown in FIGS. 25-27), the procedure begins via making two small incisions 880, 882 in the skin 830 (and underlying tissues/muscles 832) on opposite lateral sides of the underlying nerve 840, as shown in FIG. 31. At least one of the incisions 880, 882 will have a width (W6) generally corresponding to the width (W4 in FIG. 25) of the electrode strip 815.").
Regarding claim 35, the method of claim 9 is obvious over Brunnett, Imran, and Christopherson, as explained above. Brunnett further discloses that the first and second cuts are in a direction parallel to an axis of the blood vessel (Fig. 14 shows that the incision in sheath 502 is parallel to the surrounding tissues 512, 514, and the edges of fingers 416, 418 are parallel to the surrounding tissues 512, 514).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Brunnett et al. (US 20100145221 A1, previously cited), hereinafter Brunnett, in view of Imran et al. (US 20080140152 A1), hereinafter Imran, and further in view of Burnes et al. (US 20090276025 A1, previously cited), hereinafter Burnes.
Regarding claim 13, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Brunnett further discloses:
delivering the electrical signal via the at least one first electrode (paragraph [0126], "stimulating the nerve via the cuff electrode"); and
determining a patient response to the electrical signal (paragraph [0126], "this neurogenic response is measured at an innervated muscle or directly at the nerve").
Brunnett does not explicitly disclose modifying a position of the one or more electrodes based on a comparison of the patient response to a response threshold. However, Burnes teaches a method of medical lead placement (Abstract) wherein the position of the one or more electrodes is modified based on a comparison of the patient response to a response threshold (paragraphs [0055], [0111], [0134], [0136]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brunnett and Imran with the teachings of Burnes to modify a position of the one or more electrodes based on a comparison of the patient response to a response threshold, because doing so improves the efficacy of the stimulation treatment (Burnes, paragraph [0055]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Brunnett et al. (US 20100145221 A1, previously cited), hereinafter Brunnett, in view of Imran et al. (US 20080140152 A1), hereinafter Imran, and further in view of Burnes et al. (US 20090276025 A1, previously cited), hereinafter Burnes, and Cezo (US 20230233095 A1, previously cited).
Regarding claim 14, the method of claim 13 is obvious over Brunnett, Imran, and Burnes, as explained above. Brunnett does not explicitly dislcose displaying the patient response; and displaying the response threshold relative to the patient response to visualize a comparison. However, Cezo teaches a system of acquiring blood pressure data while stimulating the sympathetic nervous system (paragraph [0006]), wherein the system:
displays the patient response; and
displays the response threshold relative to the patient response to visualize a comparison (paragraph [0008], "the processor circuit is configured to perform a comparison based on the first blood flow resistance and the second blood flow resistance, wherein the comparison comprises a determination of whether a difference between the first blood flow resistance and the second blood flow resistance exceeds a threshold difference, wherein the screen display comprises a visual representation based on the determination").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brunnett, Imran, and Burnes with the teachings of Cezo to display the patient response; and display the response threshold relative to the patient response to visualize a comparison, because doing so can be used to assess the patient's responsiveness to sympathetic nervous system stimulation (Cezo, paragraph [0059]).
Claims 16-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Brunnett et al. (US 20100145221 A1, previously cited), hereinafter Brunnett, in view of Imran et al. (US 20080140152 A1), hereinafter Imran, and further in view of Shuros et al. (US 20100228310 A1, previously cited), hereinafter Shuros.
Regarding claim 16, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Although Brunnett discloses monitoring the patient's response to stimulation (paragraph [0126]), Brunnett does not explicitly disclose selecting a first electrode of the signal delivery device to deliver a first electrical signal to the patient; delivering the first electrical signal via the first electrode; determining that a patient response to the electrical signal is less than a response threshold; and after determining the patient response, delivering a second electrical signal via a second electrode to the signal delivery device different than the first electrode.
However, Shuros teaches an autonomic nervous system stimulator (paragraph [0008]) wherein the stimulator:
selects a first electrode of the signal delivery device to deliver a first electrical signal to the patient (paragraph [0051]);
delivers the first electrical signal via the first electrode (paragraph [0051]);
determines that a patient response to the electrical signal is less than a response threshold (paragraph [0052]); and
after determining the patient response, delivers a second electrical signal via a second electrode to the signal delivery device different than the first electrode (paragraph [0052]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brunnett and Imran with the teachings of Shuros so that the device selects a first electrode of the signal delivery device to deliver a first electrical signal to the patient; delivers the first electrical signal via the first electrode; determines that a patient response to the electrical signal is less than a response threshold; after determines the patient response, delivering a second electrical signal via a second electrode to the signal delivery device different than the first electrode, because doing so ensures that the stimulation causes the desired effects in the individual patient (Shuros, paragraph [0053]).
Regarding claim 17, the method of claim 16 is obvious over Brunnett, Imran, and Shuros, as explained above. Brunnett does not explicitly disclose determining that the patient response to the second electrical signal is equal to or greater than the response threshold; and delivering a therapy signal to the patient via the second electrode.
However, Shuros further teaches:
determining that the patient response to the second electrical signal is equal to or greater than the response threshold (paragraph [0052]); and
delivering a therapy signal to the patient via the second electrode (paragraph [0052]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brunnett and Imran with the teachings of Shuros so that the device determines that the patient response to the second electrical signal is equal to or greater than the response threshold; and delivers a therapy signal to the patient via the second electrode, because doing so ensures that the stimulation causes the desired effects in the individual patient (Shuros, paragraph [0053]).
Regarding claim 18, the method of claim 17 is obvious over Brunnett, Imran, and Shuros, as explained above. Brunnett does not explicitly disclose that the patient response includes a change to a blood pressure of the patient. However, Shuros further teaches that the patient response includes a change to a blood pressure of the patient (paragraph [0071]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brunnett and Imran with the teachings of Shuros so that the patient response includes a change to a blood pressure of the patient, because doing so ensures that the stimulation causes the desired effects in the individual patient (Shuros, paragraph [0053]).
Regarding claim 21, the method of claim 16 is obvious over Brunnett, Imran, and Shuros, as explained above. Brunnett does not explicitly disclose that the patient response includes a change in a heart rate of the patient and wherein determining that the patient response is less than the response threshold includes determining that the change in the heart rate of the patient is less than 5% or 10%.
However, Shuros further teaches that the change in the heart rate of the patient is used to determine whether to change stimulation parameters (paragraph [0071]).
Although neither Brunnett, nor Imran, nor Shuros explicitly discloses that the response threshold is a change in the heart rate of the patient of 5% or 10%, would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a threshold of 5% or 10%, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claims 22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Brunnett et al. (US 20100145221 A1, previously cited), hereinafter Brunnett, in view of Imran et al. (US 20080140152 A1), hereinafter Imran, and further in view of Tockman et al. (US 20130172973 A1, previously cited), hereinafter Tockman.
Regarding claim 22, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Brunnett further discloses:
implanting a pulse generator inferior to the signal delivery device, wherein the pulse generator is configured to generate the electrical signal (paragraph [0034], "the electrodes of the present disclosure also are employable with implantable stimulators"; Fig. 1A, paragraph [0039], "the stimulation module 40 of monitor 12 applies a stimulation signal to nerve 22 via stimulation electrode 20"); and
electrically coupling the signal delivery device to the pulse generator (Fig. 14, paragraph [0137], lead 430/lead 182, 360; paragraph [0116], "a proximal portion of lead 182 extends outwardly from the proximal end 156 of the body 152 for electrical connection to, and electrical communication with, the monitor 12").
Brunnett does not explicitly disclose that the pulse generator is implanted inferior to the signal delivery device.
However, Tockman teaches a stimulation electrode assembly for stimulation of a vagus nerve within a carotid sheath (Abstract), wherein a pulse generator is implanted inferior to the signal delivery device (Fig. 1, paragraph [0064], pulse generator 22 is implanted in the patient's pectoral region, which is inferior to the insulating sheath 26 surrounding the carotid sheath 10).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brunnett and Imran with the teachings of Tockman so that the pulse generator is implanted inferior to the signal delivery device, because doing so allows excess lead length to be coiled up in the subcutaneous pocket near the pulse generator (Tockman, paragraph [0064]).
Regarding claim 25, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Although Brunnett further discloses suturing the signal delivery device to structures surrounding or adjacent to the target nerve after positioning the signal delivery device (paragraphs [0142], [0144]), Brunnett does not explicitly disclose, after positioning the second region of the signal delivery device at least partially over the first region, coupling or suturing a first end of the first region to a second end of the second region.
However, Tockman teaches a stimulation electrode assembly for stimulation of a vagus nerve within a carotid sheath (Abstract), wherein, after positioning the second region of the signal delivery device at least partially over the first region, a first end of the first region is coupled or sutured to a second end of the second region (Fig. 2B, paragraph [0048]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brunnett and Imran with the teachings of Tockman so that after positioning the second region of the signal delivery device at least partially over the first region, a first end of the first region is coupled or sutured to a second end of the second region, because doing so prevents the signal delivery device from unrolling (Tockman, paragraph [0060]).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Brunnett et al. (US 20100145221 A1, previously cited), hereinafter Brunnett, in view of Imran et al. (US 20080140152 A1), hereinafter Imran, and further in view of Christopherson et al. (US 20120089153 A1, previously cited), hereinafter Christopherson, and Tockman et al. (US 20130172973 A1, previously cited), hereinafter Tockman.
Regarding claim 32, the method of claim 9 is obvious over Brunnett, Imran, and Christopherson, as explained above. Brunnett does not explicitly disclose that positioning the first region further comprises positioning the first region such that a distal end of the first region extends through the first cut through the opening and beyond the second cut.
However, Tockman teaches a stimulation electrode assembly for stimulation of a vagus nerve within a carotid sheath (Abstract), wherein forming the opening includes making a first cut at a first side of the target region and a second cut at a second side of the target region spaced apart from the first side (paragraph [0061]; paragraph [0044], "The insulating sheath 26 can surround certain components or contents within the carotid sheath 10, such as the vagus nerve 6 by itself (as shown in FIG. 6)"; paragraph [0062], "The stimulation electrode assembly can be implanted between tissue or layers of fascia of the carotid sheath. A trocar can be used, for example, to separate fibers or tissue in order to implant the insulating sheath within the carotid sheath."), and wherein positioning the first region further comprises positioning the first region such that a distal end of the first region extends through the first cut through the opening and beyond the second cut (Fig. 6, paragraph [0048]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brunnett, Imran, and Christopherson with the teachings of Tockman so that positioning the first region further comprises positioning the first region such that a distal end of the first region extends through the first cut through the opening and beyond the second cut, because doing so allows a surgeon to pull the signal delivery device around the target region and secure the device using sutures (Tockman, paragraph [0048]).
Claims 34 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Brunnett et al. (US 20100145221 A1, previously cited), hereinafter Brunnett, in view of Imran et al. (US 20080140152 A1), hereinafter Imran, and further in view of Franke et al. (US 20150202444 A1), hereinafter Franke.
Regarding claim 34, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Although Brunnett further discloses that the nerve fibers are located adjacent to a common carotid artery (paragraph [0143]), Brunnett does not explicitly disclose that the target region is located at a carotid sinus of the patient.
However, Franke teaches systems and methods for selectively blocking or stimulating nerve fibers innervating the carotid sinus region (paragraph [0003]) wherein the system is configured to deliver stimulation through electrodes to neural targets in the carotid sinus region (paragraphs [0069], [0077], [0080]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brunnett and Imran with the teachings of Franke so that the target region is located at a carotid sinus of the patient, because doing so allows the ability to selectively block or stimulate nerve fibers innervating the carotid sinus region, and strategically excite baroreceptor nerves while blocking chemoreceptor nerves (Franke, paragraph [0006]).
Regarding claim 40, the method of claim 1 is obvious over Brunnett and Imran, as explained above. Brunnett does not explicitly disclose that the baroreceptor afferent nerve fibers are spatially dispersed.
However, Franke teaches systems and methods for selectively blocking or stimulating nerve fibers innervating the carotid sinus region (paragraph [0003]) wherein the baroreceptor afferent nerve fibers are spatially dispersed (paragraph [0032]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brunnett and Imran with the teachings of Franke so that the baroreceptor afferent nerve fibers are spatially dispersed, because doing so allows stimulation of a tissue area with a high concentration of baroreceptors (Franke, paragraph [0032]).
Claims 42 is rejected under 35 U.S.C. 103 as being unpatentable over Brunnett et al. (US 20100145221 A1, previously cited), hereinafter Brunnett, in view of Imran et al. (US 20080140152 A1), hereinafter Imran, and further in view of Lerner (US 20180104491 A1, previously cited), and Gelfand et al. (US 20130303876 A1), hereinafter Gelfand.
Regarding claim 42, the method of claim 41 is obvious over Brunnett, Imran, and Lerner, as explained above. Brunnett does not explicitly disclose that the portion of the circumference of the ICA is between an 8 o'clock position and a 2 o'clock position, wherein a 12 o'clock position faces a ceiling.
However, Gelfand teaches methods of planning for and/or assessment of an ablation procedure on one or both carotid bodies or carotid body chemoreceptors or carotid body nerves (Abstract). Gelfand teaches that "the nerve of Hering is a branch of the glossopharyngeal nerve to the carotid sinus and the carotid body. It is the nerve that runs downwards anterior to the internal carotid artery and communicates with the vagus and sympathetic chain and then divides in the angle of bifurcation of the common carotid artery to supply the carotid body and carotid sinus. It carries impulses from the baroreceptors in the carotid sinus, to help maintain a more consistent blood pressure, and from chemoreceptors in the carotid body via separate nerve fibers" (paragraph [0152]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brunnett, Imran, and Lerner with the teachings of Gelfand so that the portion of the circumference of the ICA is between an 8 o'clock position and a 2 o'clock position, wherein a 12 o'clock position faces a ceiling, because doing so would target the carotid sinus nerve (Gelfand, paragraph [0152]).
Conclusion
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/CHRISTINE SISON/Examiner, Art Unit 3796
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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