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 .
Election/Restrictions
Applicant’s election without traverse of Group I pertaining to claims 64-77 in the reply filed on 10 June 2026 is acknowledged.
Claims 56-63 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply. Claims 56-63 have been cancelled.
Claims 78-84 have been added as new and are elected with claims 64-77 of Group I.
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) 71 and 76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ignagni et al. (US Publication no. 2007/0265611 – disclosed by Applicant) in view of Euliano et al. (US Publication no. 2012/0215081).
In regard to claim 71, Ignagni et al. disclose an apparatus comprising: (figure 4) a lead 535 (para 47-48); a stimulator 505 configured to deliver electrical stimulation via the lead 535 (para 47-48, via implantable electrodes 510); and a controller (para 37-38, microcontroller 111 shown in figure 1 which depicts the internal layout of the stimulator 505 as associated system) in communication with the lead 535 and the stimulator 505; and wherein the stimulator is configured to deliver electrical stimulation via the lead (para 49, The stimulator 505 may be configured to emit a stimulatory signal that is communicated to the implantable electrodes 510).
Figure 4 of Ignagni et al. also may include a flow sensor 520 for monitoring breathing (para 47-51). Flow sensor 520 may communicate a signal to stimulator 505 (para 51).
Ignagni et al. is considered to describe the invention as claimed, however does not teach that the controller is configured to calculate work of breathing (WOB) for patient breaths detected via a flow sensor.
Ignagni et al. is capable of transmitting a flow sensor signal to the microcontroller of the stimulator, however Ignagni et al. does not teach calculating the work of breathing (WOB) for patient breaths detected via a flow sensor. Euliano et al. teaches that the work of breathing may be determined from flow sensor measurements (para 45-47 and 55). The work of breathing measurement quantifies the effort a patient must take to breathe. Modifying the microcontroller of Ignagni et al. to quantify the work of breathing from the flow sensor would optimize respiratory support therapy delivered to a patient by supplying support to reduce the effort required to take a breath.
Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify Ignagni et al. to determine the work of breathing from the flow sensor since Euliano et al. demonstrate that work of breathing measurement can be obtained from flow sensors, the motivation for the modification would be to optimize therapeutic output to reduce the effort required by a patient to take a breath.
In regard to claim 76, Ignagni et al. includes an input device in communication with the controller, wherein the input device is configured to receive an input from a user, and the inputs include a pattern of breaths for which electrical stimulation is delivered (para 50-51, the flow sensor 520 provides input of airflow measurements which are considered to be indicative of a pattern of breaths from the user).
Claim(s) 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ignagni et al. (US Publication no. 2007/0265611 – disclosed by Applicant) in view of Euliano et al. (US Publication no. 2012/0215081), further in view of Tehrani et al. (US Publication no. 2012/0158091).
In regard to claim 77, Ignagni et al. in view Euliano et al. are considered to suggest the invention as claimed, however do not teach an input device in communication with the controller, wherein the input device is configured to receive an input from a user, and the input includes characteristics of the electrical stimulation. Tehrani et al. is directed to an implantable system for providing therapeutic electrical stimulation to the diaphragm to assist breathing. The system includes an external device 140 for patient use and compliance or monitoring; and for health care provider use, monitoring, diagnostic or treatment modification purposes (para 133, treatment modification purposes is considered to include aspects parameters for electrical stimulation therapy). Therefore, it is considered to have been obvious to one of ordinary skill in the art at the time of the invention to modify the system described by Ignagni et al. and Euliano et al. to include a device to allow user input pertaining to characteristics of electrical stimulation therapy since Tehrani et al. demonstrates this function to enable therapy modifications.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 64 and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 23 of U.S. Patent No. 12,569,681. Although the claims at issue are not identical, they are not patentably distinct from each other because present claim 64 is an obvious variation of claim 1 in view of claim 23 of the ‘681 patent.
Claim 1 of the ‘681 patent:
An apparatus comprising:
a stimulator configured to stimulate a phrenic nerve with a stimulation signal during a breath of the patient; and
a sensor configured to obtain a measurement of work exerted by the patient, wherein the measurement of work exerted by the patient includes a measurement of volume and a measurement of pressure;
wherein the stimulator is configured to modify the stimulation signal in response to the measurement of work being outside a selected range.
Claim 23 of the ‘681 patent:
The apparatus of claim 1, wherein the stimulator is connected to a lead system configured to be positioned in a neck of the patient.
Present claim 64:
An apparatus comprising:
a lead;
a stimulator configured to deliver electrical stimulation via the lead; and
a controller in communication with the lead and the stimulator, where the controller is configured to: calculate work of breathing (WOB) for patient breaths detected by a flow sensor;
control the stimulator to deliver the electrical stimulation when the WOB is less than a predetermined level; and
modify the delivery of electrical stimulation from the stimulator when the WOB meets or exceeds the predetermined level.
Claim 1 of the ‘681 patent obtains breaths from a sensor in order to obtain a measurement of the work of breathing. The measurement here is considered analogous to a calculation since it comprises a determination of the parameter. Additionally, the narrow requirements for the measurement in the ‘681 patent are considered to anticipate the broader determination in present claim 64 which does not impose any particular limit on the information used. Both claim sets use the work of breathing to alter and guide stimulation provided by the stimulator. The controller of present invention is also considered a necessary component of the stimulator and sensor structure of the ‘681 patent for controlling operations of the stimulator output and analysis of the sensor input. The language employed in present claim 64 for applying stimulation below when the WOB is less than a predetermined level and to modify the stimulation when the WOB exceeds a predetermined level is considered an alternative way of saying that the stimulation is modified when the WOB is outside of a selected range since the WOB exceeding a limit would necessarily fall outside of the selected range. Last, claim 23 of the ‘681 supplies the lead structure.
Claim 1 of the ‘681 patent:
An apparatus comprising:
a stimulator configured to stimulate a phrenic nerve with a stimulation signal during a breath of the patient; and
a sensor configured to obtain a measurement of work exerted by the patient, wherein the measurement of work exerted by the patient includes a measurement of volume and a measurement of pressure;
wherein the stimulator is configured to modify the stimulation signal in response to the measurement of work being outside a selected range.
Claim 23 of the ‘681 patent:
The apparatus of claim 1, wherein the stimulator is connected to a lead system configured to be positioned in a neck of the patient.
Present claim 71:
An apparatus comprising:
a lead;
a stimulator configured to deliver electrical stimulation via the lead; and
a controller in communication with the lead and the stimulator; wherein the controller is configured to calculate work of breathing (WOB) for patient breaths detected via a flow sensor; and
wherein the stimulator is configured to deliver electrical stimulation via the lead.
Claim 1 of the ‘681 is considered to present a narrower recitation on the apparatus of present claim 71, such that claim 71 is also considered an obvious variation of claim 1 of the ‘681. The controller of present invention is also considered a necessary component of the stimulator and sensor structure of the ‘681 patent for controlling operations of the stimulator output and analysis of the sensor input.
Allowable Subject Matter
Claims 64-70 are allowed.
Claims 72-75 and 78-84 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 following is an examiner’s statement of reasons for allowance: the prior art fails to teach use of the work of breathing to control simulation.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. 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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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 23 June 2026
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