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 .
Prosecution Reopened
In view of the Appeal Brief filed on May 13, 2026 PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/DAVID HAMAOUI/ SPE, Art Unit 3796
Response to Arguments
Applicant’s arguments, see appeal brief, filed May 13, 2026, with respect to the rejection(s) of claim(s) 1, 3, 5-6, 8-17, 20-21, 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 Therefore, the rejection has been withdrawn.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 Bornzin et al. (US 2022/0105353).
Claim Objections
Claim 14 is objected to because of the following informalities: Claim 14 introduces a second prong configured to be positioned adjacent to a second blood vessel, and a second electrode configured to be positioned adjacent to the second blood vessel. However, this second electrode is required to be, “on the distal end of the first prong”. Given the context, it appears this second electrode should be stated as, “on the distal end of the second prong”. Appropriate correction is required.
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, 5-6, 10-17, 21, 24-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chekanov (US 6,201,991) in view of Bornzin et al. (US 2022/0105353) and Gibson (US 8,774,929).
Regarding claims 1, 17, 21, Chekanov discloses a subcutaneously implantable device 24 (col. 2, lines 50-52) and method of preventing and treating atherosclerosis (col. 2, lines 6-10) using the subcutaneous device comprising: an housing; a first prong (“lead”) with a proximal end attached to a bottom side of the housing, which is opposite a top side of the housing, and a distal end extending away from the bottom side of the housing and is configured to be positioned adjacent to a first blood vessel 16 (fig. 1); a first electrode 22 on the distal end of the first prong that is configured to be positioned adjacent to the first blood vessel; and circuitry in the housing in electrical communication with the first electrode that is configured to deliver electrical stimulation using the first electrode create an electric field around the first blood vessel (“The pulse generator and lead can be positioned on opposite sides of the vessel being treated in order to create an electrical field about the vessel” col. 2, lines 35-43).
Chekanov does not expressly disclose holding the subcutaneous device in position on the first rib and the second rib, the housing configured to fit in an intercostal space between the first rib and the second rib; and the first prong extends through the intercostal space between the first rib and the second rib. Bornzin et al. teaches a subcutaneously implantable device for stimulating a similar area of the chest ([0006]) comprising: a housing 512 configured to fit in an intercostal space between a first rib and a second rib (in one embodiment, “the lead 514 and IMD 512 can be located at another intercostal space, such as the fifth (5th)” [0068], fig. 10; or in another embodiment, “the IMD 512 is mounted on or to the lead anchor 520” [0069], with “lead anchor 20 is secured to the chest wall at the 5.sup.th intercostal space” [0037]) and held in position on the first rib and second rib (“Although lead anchor 120 is secured to the muscular fascia in FIG. 5, the lead anchor 120 may be secured to other anatomical structures of the chest wall of the patient instead of, or in addition to the muscular fascia, in other embodiments. Such other anatomical structures can include bone” [0049], this “bone” regarded as the immediately adjacent rib bones); a first prong 514 (fig. 11) extending through an intercostal space between a first rib and a second rib (“The lead 514 may be implanted through the intercostal space” [0068]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to position the subcutaneous device in position on the first rib and the second rib, the housing configured to fit in an intercostal space between the first rib and the second rib, and the first prong extending through the intercostal space between the first rib and the second rib as taught by Bornzin et al. in order to provide a device that minimizes the number of incisions and pockets required for implanting the device ([0005], [0068]) thus reducing infections and other complications that increase with each incision ([0004]), the placement of the subcutaneous device and the lead within the intercostal space being known in the art, the results of such a modification being reasonably predictable.
Chekanov in view of Bornzin et al. does not expressly disclose a first anchoring arm attached to a first side of the housing that is configured to anchor the device to the first rib; and a second anchoring arm attached to a second side of the housing, the second side of the housing being opposite the first side of the housing, that is configured to anchor the device to the second rib, wherein the first anchoring arm and the second anchoring arm are sized and shaped to hold the subcutaneous device in position on the first rib and the second rib. Gibson teaches the concept of anchoring an subcutaneously implantable device to bone by providing a first anchoring arm 39 attached to a first side of a housing and a second anchoring arm 39 attached to a second side of the housing, the second side of the housing being opposite the first side of the housing, is known in the art (fig. 3, 5). Gibson additionally teaches the concept of sizing the anchoring arms to be appropriate for the bone it is intended to be attached to (“the basic size of the faceplate 37 is designed to be just larger than the size of the mastoid cavity 35, allowing the faceplate 37 to be stabilised on the rim of the mastoidectomy” col. 7, lines 6-8) and shaping the anchoring arms to hold the device in position on the bone (“The flanges 39 are formed so as to be relatively robust whilst also sufficiently malleable so that the entire faceplate 37 can be formed to the shape of the skull surrounding the mastoid cavity by the surgeon” col. 6, lines 13-16). The mastoid cavity and the surrounding rim of skull bone is regarded as analogous to the intercostal space and the surrounding first and second ribs. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chekanov to include a first anchoring arm attached to a first side of the housing that is configured to anchor the device to the first rib; and a second anchoring arm attached to a second side of the housing, the second side of the housing being opposite the first side of the housing, that is configured to anchor the device to the second rib, wherein the first anchoring arm and the second anchoring arm are sized and shaped to hold the subcutaneous device in position on the first rib and the second rib, as taught Gibson in order to securely stabilize the subcutaneous implantable device in position on the first rib and the second rib within the intercostal space while protecting the subcutaneous device (“the receiver/stimulator unit 38 extends into the mastoid cavity 35 and is protected by the faceplate 37 which acts as a protecting shield for the unit 38 as well as a stabiliser and means for securing the unit 38 in place” col. 5, line 66 to col. 6, line 4).
Regarding claims 3 and 5, Chekanov in view of Gibson discloses the first anchoring arm 39 comprises at least one tine 36 configured to pierce the first rib, and wherein the second anchoring arm 39 comprises at least one tine 36 configured to pierce the second rib (col. 5, lines 57-59).
Regarding claim 6, Chekanov in view of Gibson discloses the first anchoring arm and the second anchoring arm are integrally formed with the housing (“The flanges of the faceplate 37 can be a simple extension of the upper surface of the receiver/stimulator unit and made from the same material as the rest of the receiver/stimulator unit.” col. 6, lines 6-9).
Regarding claim 10, Chekanov discloses the first prong further comprises: a base portion on the proximal end of the first prong; an arm portion extending from the base portion; and a therapeutic portion extending from the arm portion and terminating at the distal end of the first prong, wherein the first electrode 22 is positioned on the therapeutic portion of the first prong (fig. 1).
Regarding claim 11, of Chekanov discloses the electrical stimulation that is provided using the first electrode is pulsating electrical stimulation to create a pulsating electric field between and around the first electrode and the housing (col. 2, lines 17-23, 36-52).
Regarding claim 12, Chekanov discloses wherein a frequency of the pulsating electrical stimulation is between 1 pulse per minute and 30 pulses per minute (“The electrical impulse can be emitted at a rate of 30-120 beats per minute” col. 2, lines 66-67).
Regarding claim 13, Chekanov discloses wherein the amplitude of the pulsating electrical stimulation is between 0.5 volts and 4.0 volts (col. 2, lines 65-66) at a pulse width of 250 milliseconds to 1000 milliseconds (col. 2, lines 65-66).
Regarding claim 14, Chekanov discloses a second prong with a distal end extending away from the housing that is configured to be positioned adjacent to a second blood vessel (“an electrical lead or leads that are either implanted into the muscle or connective tissue proximal to the vessel… to create an electrical field” col. 3, lines 45-47); and a second electrode on the distal end of the second prong (see objection) that is configured to be positioned adjacent to the second blood vessel (obvious to one of ordinary skill in the art that an electrode would be on the distal end of the electrical lead, much like that shown in fig. 1); wherein the circuitry in the housing is in electrical communication with the second electrode and is configured to deliver electrical stimulation using the second electrode to create an electric field around the second blood vessel (col. 3, lines 45-47).
Regarding claim 15, Chekanov discloses the electrical stimulation that is provided using the first electrode and the second electrode is pulsating electrical stimulation to create a pulsating electric field between and around the first electrode and the second electrode (col. 2, lines 17-23, 36-52).
Regarding claim 16, Chekanov discloses the electrical stimulation that is provided using the first electrode is pulsating electrical stimulation to create a pulsating electric field between and around the first electrode and the housing and a pulsating electric field between and around the second electrode and the housing (col. 2, lines 17-23, 36-52).
Regarding claim 24, Chekanov in view of Gibson does not expressly disclose wherein the first anchoring arm is a first curved anchoring arm, and the second anchoring arm is a second curved anchoring arm such that the first curved anchoring arm and the second curved anchoring arm hold the subcutaneous device in position on the first rib and the second rib. However, Gibson teaches the concept of shaping the anchoring arms to hold the device in position on the bone (“The flanges 39 are formed so as to be relatively robust whilst also sufficiently malleable so that the entire faceplate 37 can be formed to the shape of the skull surrounding the mastoid cavity by the surgeon” col. 6, lines 13-16). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to curve the first anchoring arm and the second anchoring arm as taught by Gibson, in order to better to conform the shape of the anchoring arms to the anatomy of the first rib and the second rib and to better hold the subcutaneous device in position on the first rib and the second rib.
Regarding claim 25, Chekanov in view of Gibson disclose the first anchoring arm comprises: a body extending from the first side of the housing 39 and an opening extending through the body from a top side of the body to a bottom side of the body and configured to allow the first anchoring arm to be sutured to the first rib or to receive a fixation mechanism 36 to secure the first anchoring arm to the first rib (col. 5, lines 57-60; fig. 3-5); and the second anchoring arm comprises: a body extending from the first side of the housing 39 and an opening extending through the body from a top side of the body to a bottom side of the body and configured to allow the second anchoring arm to be sutured to the second rib or to receive a fixation mechanism 36 to secure the second anchoring arm to the second rib (col. 5, lines 57-60; fig. 3-5).
Regarding claim 26, Chekanov in view of Gibson disclose the first anchoring arm comprises at least one tine 36 configured to pierce the first rib, and the second anchoring arm comprises at least one tine 36 configured to pierce the second rib such that the first anchoring arm and the second anchoring arm hold the subcutaneous device in position on the first rib and the second rib (col. 5, lines 57-60, fig. 3-5).
Regarding claim 27, Chekanov discloses a subcutaneously implantable device 24 (col. 2, lines 50-52) comprising: an housing; a first prong (“lead”) with a proximal end attached to a bottom side of the housing, which is opposite a top side of the housing, and a distal end extending away from the bottom side of the housing and is configured to be positioned adjacent to a first blood vessel 16 (fig. 1); a first electrode 22 on the distal end of the first prong that is configured to be positioned adjacent to the first blood vessel; and circuitry in the housing in electrical communication with the first electrode that is configured to deliver electrical stimulation using the first electrode create an electric field around the first blood vessel (“The pulse generator and lead can be positioned on opposite sides of the vessel being treated in order to create an electrical field about the vessel” col. 2, lines 35-43).
Chekanov does not expressly disclose holding the subcutaneous device in position on the first rib and the second rib, the housing configured to fit in an intercostal space between the first rib and the second rib; and the first prong extends through the intercostal space between the first rib and the second rib. Bornzin et al. teaches a subcutaneously implantable device for stimulating a similar area of the chest ([0006]) comprising: a housing 512 configured to fit in an intercostal space between a first rib and a second rib (in one embodiment, “the lead 514 and IMD 512 can be located at another intercostal space, such as the fifth (5th)” [0068], fig. 10; or in another embodiment, “the IMD 512 is mounted on or to the lead anchor 520” [0069], with “lead anchor 20 is secured to the chest wall at the 5.sup.th intercostal space” [0037]) and held in position on the first rib and second rib (“Although lead anchor 120 is secured to the muscular fascia in FIG. 5, the lead anchor 120 may be secured to other anatomical structures of the chest wall of the patient instead of, or in addition to the muscular fascia, in other embodiments. Such other anatomical structures can include bone” [0049], this “bone” regarded as the immediately adjacent rib bones); a first prong 514 (fig. 11) extending through an intercostal space between a first rib and a second rib (“The lead 514 may be implanted through the intercostal space” [0068]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to position the subcutaneous device in position on the first rib and the second rib, the housing configured to fit in an intercostal space between the first rib and the second rib, and the first prong extending through the intercostal space between the first rib and the second rib as taught by Bornzin et al. in order to provide a device that minimizes the number of incisions and pockets required for implanting the device ([0005], [0068]) thus reducing infections and other complications that increase with each incision ([0004]), the placement of the subcutaneous device and the lead within the intercostal space being known in the art, the results of such a modification being reasonably predictable.
Chekanov in view of Bornzin et al. does not expressly disclose a first curved anchoring arm attached to a first side of the housing that is configured to anchor the device to the first rib; and a second curved anchoring arm attached to a second side of the housing, the second side of the housing being opposite the first side of the housing, that is configured to anchor the device to the second rib, wherein the first anchoring arm and the second anchoring arm are sized and shaped to hold the subcutaneous device in position on the first rib and the second rib. Gibson teaches the concept of anchoring an subcutaneously implantable device to bone by providing a first anchoring arm 39 attached to a first side of a housing and a second anchoring arm 39 attached to a second side of the housing, the second side of the housing being opposite the first side of the housing, is known in the art (fig. 3, 5). Gibson additionally teaches the concept of sizing the anchoring arms to be appropriate for the bone it is intended to be attached to (“the basic size of the faceplate 37 is designed to be just larger than the size of the mastoid cavity 35, allowing the faceplate 37 to be stabilised on the rim of the mastoidectomy” col. 7, lines 6-8) and shaping the anchoring arms to hold the device in position on the bone (“The flanges 39 are formed so as to be relatively robust whilst also sufficiently malleable so that the entire faceplate 37 can be formed to the shape of the skull surrounding the mastoid cavity by the surgeon” col. 6, lines 13-16). The mastoid cavity and the surrounding rim of skull bone is regarded as analogous to the intercostal space and the surrounding first and second ribs. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chekanov to include a first curved anchoring arm attached to a first side of the housing that is configured to anchor the device to the first rib; and a second curved anchoring arm attached to a second side of the housing, the second side of the housing being opposite the first side of the housing, that is configured to anchor the device to the second rib, wherein the first anchoring arm and the second anchoring arm are sized and shaped to hold the subcutaneous device in position on the first rib and the second rib, as taught Gibson in order to better conform the shape of the anchoring arms to the anatomy of the first rib and the second rib and to securely stabilize the subcutaneous implantable device in position on the first rib and the second rib within the intercostal space while protecting the subcutaneous device (“the receiver/stimulator unit 38 extends into the mastoid cavity 35 and is protected by the faceplate 37 which acts as a protecting shield for the unit 38 as well as a stabiliser and means for securing the unit 38 in place” col. 5, line 66 to col. 6, line 4).
Claim(s) 8-9, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chekanov (US 6,201,991) in view of Bornzin et al. (US 2022/0105353) and Gibson (US 8,774,929) and further in view of Manicka (US 2020/0077953).
Regarding claims 8, 20, Chekanov does not expressly disclose the first prong is made of a stiff material that is capable of pushing through tissue in a body of a patient. Manicka teaches a prong 106 made of a stiff material so that it is capable of pushing through tissue in the body when a subcutaneous device is implanted in a patient ([0124]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chekanov to select a stiff material for the first prong in order to better assist in the implantation of the first prong through the intercostal space, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 9, Chekanov in view of Manicka teaches the first prong is made out of a material selected from the group consisting of nickel titanium (Nitinol), silicone, polyurethane, stainless steel, titanium, epoxy, polyurethane with metallic reinforcements, and any combination thereof ([0124]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lee (US 2004/0167416) discloses device 10 at a location over the ribs such that sensor 22 is aligned with an intercostal space (fig. 5a). Lee also discloses a sensor assembly 28 anchored in a position over the ribs, positioned over an intercostal space 5 (fig. 5b) to transmit ultrasonic energy toward the heart and receive good acoustical signals from the heart ([0053]). Lee discloses an ultrasonic sensor aligned with an intercostal space is believed to be more practical for chronic implantation with minimal patient discomfort as compared to implantation at a suprasternal notch ([0054]). Lee however does not disclose a device for delivering electrical stimulation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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