DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 4/30/2025 and 8/26/2025 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference numeral “73” in Fig. 1. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because:
In Fig. 3, stray “312” not associated with any structure;
In Fig. 4A, stray “332” not associated with any structure;
In Fig. 4B, stray “332” not associated with any structure;
In Fig. 4D (i.e., page 6 of the Drawings), there is a stray indicator line at the distal end of the device without a reference numeral;
In Fig. 5C, stray reference numerals “310”, “312”, “376” and “378” not associated with any structure; and
In Figs. 6A-7A, (i.e., page 12 of the Drawings), the three respective figures appear to be confusingly superimposed over each other.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 7-8 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.
Regarding claim 7 (and thereby dependent claim 8), the phrase "a distal electrode" in lines 1-2 renders the claim(s) indefinite because a distal electrode was already introduced in line 6 of claim 6, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the distal electrode of claim 6 or introduce a new, additional distal electrode. To move prosecution forward, the examiner assumed applicant intended to refer back to the distal electrode of claim 6. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 6, 11-13, 22-23 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burnes et al. (US 2013/0150939).
Burnes discloses (see Figs. 9-11) a system and method for placing medical leads for electrical stimulation of nerve tissue comprising the following claim limitations:
(claim 6) A method for implanting a baroreflex activation device (29/228, Fig. 9) into a patient (as shown in Figs. 9-10), comprising: inserting a needle (226, Fig. 9; [0103]) into the patient at an implant site near a carotid artery (as shown in Fig. 9; [0102]; while Fig. 9 depicts the jugular vein 158, the same method is expressly disclosed for use in the carotid artery), the needle (226) having a body and a lumen defined along the body (as shown in Fig. 9; lumen shown containing guidewire 230 therein), the needle (226) inserted in a first direction toward the carotid artery (as shown in Fig. 9; needle insertion generally shown to be “upward”); loading the baroreflex activation device (29/228) into a proximal end of the needle (226) (see step 244, Fig. 10; [0101]; [0103]; to exit the distal end (as shown in Fig. 9), the baroreflex activation device must previously enter the proximal end); advancing the baroreflex activation device (29/228) along the lumen until a distal electrode (228, Fig. 9) of the baroreflex activation device extends beyond a distal tip of the needle (226) (as shown in Fig. 9; [0101]-[0104]); positioning the distal electrode (228) of the baroreflex activation device against the carotid artery (158, Fig. 9) ([0102]; while Fig. 9 depicts the jugular vein 158, the same method is expressly disclosed for use in the carotid artery); and retracting the needle (226) in a second direction opposite the first direction until the needle (226) is removed from the patient ([0100]; [0103]; [0109]; [0118]; [0136]; delivery components removed after delivery of lead, wherein only the lead is expressly left in the body and connected to an IMD to be commanded by a programmer);
(claim 11) wherein the distal electrode (228) includes an anchoring feature selected from the group consisting of a tab (231, Fig. 9) and a screw for fixation at or near the carotid artery (158) (as shown in Fig. 9; [0104]);
(claim 12) wherein the baroreflex activation device is secured to the carotid artery (158) using passive fixation elements (231) embedded within the device (as shown in Fig. 9; [0095]; [0155]; barbs/tabs 231 style anchors expressly disclosed as being passive anchors for engaging tissue);
(claim 13) wherein the baroreflex activation device (29/228) comprises a monopolar, bipolar, or multipolar electrode configuration for baroreflex activation therapy (see Fig. 9; [0048]; unipolar and bipolar configurations expressly disclosed);
(claim 22) wherein the baroreflex activation device is configured to (i.e., capable of) deliver electrical stimulation to baroreceptors upon fixation at or near the carotid artery (158) (as shown in Fig. 9 and step 246 in Fig. 10; [0100]; [0102]; [0106]-[0109]; step of electrical stimulation expressly disclosed);
(claim 23) wherein the needle (226) is inserted into the patient with positioning guided by imaging means to facilitate access to the carotid artery (158) while maintaining depth control (as shown in Fig. 9; [0038]-[0039]; [0059]; [0099]; [0102]; [0105]; [0108]; assisting delivery via imaging means expressly disclosed); and
(claim 25) wherein the baroreflex activation device is configured to (i.e., capable of) adjust therapy signal parameters based on a measured sensor signal indicative of a patient's physiological state (see step 248, Fig. 10; [0080]; [0100]; [0106]-[0107]; [0109]; automatically adjusting programming based on sensor feedback expressly disclosed).
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.
Claim(s) 7-8 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Burnes as applied to claim 6 above, and further in view of Pierce et al. (US 2019/0224484).
Burnes, as applied above, discloses a system and method for placing medical leads for electrical stimulation of nerve tissue comprising all the limitations of the claim except for a distal electrode and one or more proximal electrodes, the distal electrode being connected to the one or more proximal electrodes via a link housing one or more conductors, wherein the link includes one or more shape elements made from a shape memory material, configured to bias the link into an arcuate shape upon deployment, and wherein the baroreflex activation device includes a wraparound, looped, or semi-rigid element configured to circumferentially engage the carotid artery.
However, Pierce teaches (see Fig. 66) a similar system and method for stimulating baroreceptors at a portion of the carotid artery ([0007]; [0011]) comprising a distal electrode (i.e., distalmost i.e., electrode 6630, as shown in Fig. 66) and one or more proximal electrodes (i.e., the remainder of electrodes 6630, as shown in Fig. 66), the distal electrode being connected to the one or more proximal electrodes via a link (6640, Fig. 66) housing one or more conductors (([0156]), wherein the link (6640) includes one or more shape elements made from a shape memory material ([0156]; shape memory alloy such as nickel titanium expressly taught), configured to (i.e., capable of) bias the link (6640) into an arcuate shape upon deployment (as expressly shown in Fig 66; [0156]), and wherein the baroreflex activation device (6610) includes a wraparound, looped, or semi-rigid element configured to (i.e., capable of) circumferentially engage the carotid artery (as shown in Fig. 66; [0156]; the depicted looping/spiraling configuration fully capable of circumferentially engaging the carotid artery if one so desires) in order to beneficially provide a large plurality (e.g., eight electrodes depicted) of electrodes for creating tissue alterations at a plurality of locations on a vessel and promoting apposition of the electrodes against the vessel ([0024]; [0147]; [0156]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/method of Burnes to have a distal electrode and one or more proximal electrodes, the distal electrode being connected to the one or more proximal electrodes via a link housing one or more conductors, wherein the link includes one or more shape elements made from a shape memory material, configured to bias the link into an arcuate shape upon deployment, and wherein the baroreflex activation device includes a wraparound, looped, or semi-rigid element configured to circumferentially engage the carotid artery in order to beneficially provide a large plurality (e.g., eight electrodes depicted) of electrodes for creating tissue alterations at a plurality of locations on a vessel and promoting apposition of the electrodes against the vessel, as taught by Pierce.
Claim(s) 9-10 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Burnes as applied to claim 6 above, and further in view of Pillai (US 2018/0161551).
Burnes, as applied above, discloses a system and method for placing medical leads for electrical stimulation of nerve tissue comprising the following claim limitations:
(claim 21) wherein the guidewire (230, Fig. 9) comprises a shape memory alloy ([0165]-[0166]; guidewire 230 disclosed comprising Nitinol) configured to (i.e. capable of) curve upon deployment (as shown at 230A, Fig. 9).
Burnes fails to expressly disclose (but Fig. 9 does depicts off-axis deployment from needle 226) the needle including an exit port positioned proximal to the distal tip of the needle, configured to facilitate off-axis deployment of the baroreflex activation device out of the exit port of the needle using a diverter, wherein the diverter is configured as a ramp, wedge, slope, or curve to facilitate direction control of the guidewire or baroreflex activation device, and wherein the distal tip of the needle is closed, preventing direct passage of the guidewire through the end of the needle.
However, Pillai teaches (see Figs. 6A-6B) a similar carotid artery access system and method comprising the needle/access device (42) including an exit port (at 56) positioned proximal to the distal tip (47) of the needle, configured to (i.e., capable of) facilitate off-axis deployment of the baroreflex activation device out of the exit port (at 56) of the needle using a diverter (56), wherein the diverter (56) is configured as a ramp, wedge, slope, or curve (as expressly shown in Figs. 6A-6B; [0037]) to facilitate direction control of the guidewire or baroreflex activation device (as shown in Fig. 6A), and wherein the distal tip (47) of the needle is closed, preventing direct passage of the guidewire through the end of the needle (as shown in Fig. 6A, diverter ramp 56 closes the distal tip 47 and guides instruments out an off-axis exit port) in order to beneficially form a camming surface that provides both additional structural support for and promotes curvature of instruments passing therethrough as they are distally advanced in position ([0037]-[0040]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/method of Burnes to have the needle including an exit port positioned proximal to the distal tip of the needle, configured to facilitate off-axis deployment of the baroreflex activation device out of the exit port of the needle using a diverter, wherein the diverter is configured as a ramp, wedge, slope, or curve to facilitate direction control of the guidewire or baroreflex activation device, and wherein the distal tip of the needle is closed, preventing direct passage of the guidewire through the end of the needle in order to beneficially form a camming surface that provides both additional structural support for and promotes curvature of instruments passing therethrough as they are distally advanced in position, as taught by Pillai.
Claim(s) 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Burnes as applied to claim 6 above, and further in view of Demarais et al. (US 2007/0203549).
Burnes, as applied above, discloses a system and method for placing medical leads for electrical stimulation of nerve tissue comprising the following claim limitations:
(claim 16) further comprising rotating the needle (226) or adjusting the plunger to control the orientation of the baroreflex activation device during deployment ([0105]; rotating the structures of the system during use expressly disclosed for facilitating the positioning of the electrode 228 on lead 29).
Burnes fails to expressly disclose using a plunger to advance and facilitate controlled movement of the baroreflex activation device from the proximal end of the needle, through the lumen, and to the distal tip.
However, Demarais teaches (see Figs. 14A-14B) a system and method for providing electric field neuromodulation comprising using a plunger (312) to advance and facilitate controlled movement of the baroreflex activation device (310) from the proximal end of the needle (304), through the lumen, and to the distal tip (as shown in Figs. 14A-14B) in order to beneficially provide for delivery in a low-profile configuration to the intended treatment site and then subsequently allowing for user-selective distal deployment of the electrical stimulation device, and/or allowing for elastic deformation/self-expansion of any anchors, barbs, or the like to maintain the device at the intended treatment site ([0075]-[0078]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/method of Burnes to use a plunger to advance and facilitate controlled movement of the baroreflex activation device from the proximal end of the needle, through the lumen, and to the distal tip in order to beneficially provide for delivery in a low-profile configuration to the intended treatment site and then subsequently allowing for user-selective distal deployment of the electrical stimulation device, and/or allowing for elastic deformation/self-expansion of any anchors, barbs, or the like to maintain the device at the intended treatment site, as taught by Demarais.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Burnes as applied to claim 6 above, and further in view of Kume et al. (US 2017/0296798).
Burnes, as applied above, discloses a system and method for placing medical leads for electrical stimulation of nerve tissue comprising all the limitations of the claim except for the needle including depth control markings to facilitate positioning within a baroreceptive tissue plane.
However, Kume teaches (se Figs. 19A and 21A-21B) a similar method for providing transcarotid access comprising the needle (160) including depth control markings (165) to facilitate positioning within a baroreceptive tissue plane ([0091]-[0095]) in order to beneficially aid the user in assessing the amount of insertion without any special imaging aside from the naked eye ([0091]-[0095]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/method of Burnes to have the needle including depth control markings to facilitate positioning within a baroreceptive tissue plane in order to beneficially aid the user in assessing the amount of insertion without any special imaging aside from the naked eye, as taught by Kume.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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