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 .
Priority
This application is a continuation of US Application no. 17/371,316, now US Patent no. 12,029,902, filed 9 July 2021, which is a continuation of US Application no. 16/222,299, now US Patent no. 11,090,489, filed 17 December 2018, which is a continuation of US Application no. 15/666,989, now US Patent no. 10,195,429, filed 2 August 2017.
Claim Objections
Claim 46 is objected to because of the following informalities: line 8 recites “neve” which should recite as “nerve”. 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) 31, 34, 36, and 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karamanoglu (US Publication no. 2015/0165207 – disclosed by Applicant).
In regard to claim 31, Karamanoglu discloses a method for operating a medical device CRD 10 (a cardiorespiratory support device with electrode bearing lead 6, para 67), the method comprising:
positioning the device 10/6 to a first position within a vascular system of a subject (para 62, within jugular vein 40), wherein the device comprises a plurality of electrodes configured to stimulate a nerve (para 67, stimulate a phrenic nerve);
measuring an impedance using at least one electrode of the plurality of electrodes (par 99-103, electrodes may be used in pairs to measure an impedance between them; impedance is determined used impedance sensing circuitry 204A);
comparing the impedance to an impedance threshold or an impedance profile (para 130, a series of monitored phrenic electrode pair impedance amplitudes or distal pressure amplitudes are compared to determine if the last recorded value is different than a desired threshold level);
based on the comparison of the impedance to the impedance threshold or the impedance profile, selecting a combination of electrodes from the plurality of electrodes (para 131, if a determination is made that the respiration amplitude was changed the process continues either to suspend, terminate, or choose a new proximal and distal phrenic electrode pairs); and
stimulating the nerve using the combination of electrodes (para 131, block 405 to continue evaluating if it is time to start the phrenic nerve stimulation).
In regard to claim 34, in Karamanoglu the combination of electrodes includes at least one electrode (the measurement and selection is done in pairs).
In regard to claim 36, in Karamanoglu the impedance is measured between the at least one electrode of the plurality of electrodes and an electrode affixed to tissue (para 77).
In regard to claim 37, in Karamanoglu stimulating the nerve includes stimulating a left phrenic nerve, and the method further comprises stimulating a right phrenic nerve (para 73, 77, 79, 82).
Claim(s) 46 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karamanoglu et al. (US Patent no. 8,897,879 – disclosed by Applicant).
In regard to claim 46, Karamanoglu et al. disclose a method for operating a device, the method comprising (figure 5, method 200):
positioning the device at a first position within a vascular system of a subject (steps 201-202), wherein the device comprises a plurality of electrodes configured to stimulate a nerve (figure 1, IMD 10 with lead 16 bearing electrodes adapted for insertion through a vein to apply stimulation to the phrenic nerve);
measuring an impedance using at least one electrode of the plurality of electrodes (step 222);
comparing the impedance to an impedance threshold or an impedance profile; based on the comparison of the impedance to the impedance threshold or the impedance profile (step 224),
positioning the device at a second position within the vascular system of the subject (step 207, performed in response to the impedance change being greater than a threshold and the testing of various stimulation parameters the lead may be repositioned, wherein the repositioned location is considered to comprise a second position; col 11 lines 5-24); and
stimulating the nerve using the at least one electrode of the plurality of electrodes (step 226, col 11 lines 28-30).
In regard to claim 47, Karamanoglu et al. the second position within the vascular system is the subclavian vein, jugular vein, or superior vena cava (col 5 lines 47-54; col 2 line 58 – col 3 line 20).
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.
Claim(s) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karamanoglu et al. (US Patent no. 8,897,879 – disclosed by Applicant) in view of Ignagni et al. (US Publication no. 2007/0265611 – disclosed by Applicant).
In regard to claim 48, Karamanoglu et al. is considered to substantially describe the invention as claimed, however does not teach further comprising providing external respiratory assistance to the patient via positive pressure ventilation. Ignagni et al. teaches a respiratory support system that combines diaphragmatic stimulation therapy with positive pressure ventilation (figure 4). Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the stimulation system of Karamanoglu et al. to include supplementation from a positive pressure ventilation support since Ignagni et al. teaches that supplementation of stimulated respiration with positive pressure driven air flow from a PPMV helps direct move air into portions of the lung.
Claim(s) 49 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karamanoglu et al. (US Patent no. 8,897,879 – disclosed by Applicant) in view of Karamanoglu (US Publication no. 2015/0165207 – disclosed by Applicant – hereinafter Karamanoglu ‘207).
In regard to claim 49, Karamanoglu et al. is considered to substantially describe the invention as claimed, however does not teach further comprising determining a respiration rate, based on the impedance. Karamanoglu ‘207 teaches that impedance meausurements can be used to identify presence of absence of respiratory activity (para 79). Therefore, it is considered to have been obvious to one of ordinary skill in the art to determine a respiration rate based on an impedance measurement since it is explicitly taught by Karamanoglu ‘207.
In regard to claim 50, Karamanoglu et al. is considered to substantially describe the invention as claimed, however does not teach stimulating the nerve causes contraction of a respiratory muscle. Karamanoglu ‘207 teaches the result of the stimulation signals applied to either the right phrenic nerve, left phrenic nerve, or both causes the contraction of the diaphragm (para 140). Therefore, it is considered to have been obvious to one of ordinary skill in the art to elicit a respiratory muscle contraction from stimulation applied to the phrenic nerve since it is explicitly taught by Karamanoglu ‘207.
Allowable Subject Matter
Claims 39-45 are allowed.
The following is an examiner’s statement of reasons for allowance: the prior art fails to teach the steps of measuring first and second impedance levels in order to select a combination of electrodes to simulate a right phrenic nerve and to select a combination of electrodes to simulate a left phrenic nerve.
Claims 32, 33, 35, and 38 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art fails to teach the recited feature in combination with features recited in the base claim.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 24 June 2026
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