DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed March 10, 2026 has been entered. Claim 19 is amended. Claims 1-17 are withdrawn. Currently, claims 18-20 are pending for examination.
Response to Arguments
Applicant's arguments filed March 10, 2026 have been fully considered but they are not persuasive.
Regarding the double patenting rejection (p. 7), applicant requests these rejections be held in abeyance until allowable subject matter is indicated. Therefore the rejection stands.
Regarding the 35 U.S.C. 103 rejection (p. 8-11), applicant argues an interpulse interval of 50 milliseconds between adjacent pulses of a microburst as required by claim 18 is not disclosed by De Ridder (US 2006/0095090) because the prior art discloses spikes and “the interval between spikes is materially different than an interval between adjacent pulses” (p. 10). This argument is not persuasive because the “spikes” of De Ridder are synonymous to pulses. As identified in the previous Office action, De Ridder discloses, a plurality of microbursts wherein each microburst is characterized by: from 2 to 20 pulses per microburst (“each burst stimulus can comprise about 2 to about 100 spikes, more particularly, about 2 to about 10 spikes.” [0014]) and that an interpulse interval between adjacent pulses of the microburst is 50 milliseconds (“The interval between spikes can be about 0.5 milliseconds to about 100 milliseconds” [0014]). The burden then shifts to applicant to show that the element (“spikes”) shown in the prior art is not an equivalent of the structure, material or acts disclosed in the application (“pulses”). In re Mulder, 716 F.2d 1542, 219 USPQ 189 (Fed. Cir. 1983). Given that applicant has not argued the identified “spikes” of De Ridder cannot be considered the “pulses” of claim 18, simply arguing that the interval between spikes is materially different than an interval between adjacent pulses without additional rationale is unpersuasive.
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 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 11,771,902 in view of Shelchuk (US 7,139,607). Although the claims at issue are not identical, they are not patentably distinct from each other because while the patented apparatus claim 11 requires a sensor configured for detecting a portion of the cardiac cycle and an inspiration phase of the respiratory cycle, and delivering stimulation in response to detecting the portion of the cardiac cycle and the inspiration phase, claim 18 of the application merely broadens the scope by only requiring the sensor to detect a portion of the cardiac cycle and a respiratory cycle of the patient and delivering the same stimulation parameters in response to detecting a portion of the cardiac cycle and the respiratory cycle. Therefore in this respect, the application claims are merely broader in scope than the patented claims.
Claim 18 recites parameters of a delivered pulsed electrical signal comprising a plurality of microbursts with specific stimulation parameters, one of which is an interpulse interval between adjacent pulses of the microburst is 50 milliseconds. Whole the patented claim does not explicitly recite this, Shelchuk teaches it is known in the art for interpulse intervals between adjacent pulses of a microburst (“pulse train”) to be 50 milliseconds (“Exemplary ranges for pulse frequency for nerve and/or tissue stimulation include frequencies ranging from approximately… 1 Hz to approximately 20 Hz.” Col. 21, lines 20-24). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the patented claim 11 and try using an interpulse interval between adjacent pulses of a microburst to be 50 milliseconds as taught by Shelchuk as it is using a known technique to a known device ready for improvement to yield predictable results and choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Patented claims 12-13 are identical to claims 19-20 of the application.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Ridder (US 2006/0095090) in view of Haefner et al. (US 2008/0058892).
Regarding claim 18, De Ridder discloses a system for treating a medical condition in a patient comprising: a lead assembly 14 comprising at least one electrode (fig. 3-5) capable of being coupled to a vagus nerve of the patient ([0013], [0058], [0073], [0097]); an implantable medical device 12 coupled to the lead assembly (fig. 3a-b, 5) comprising: a controller for controlling an operation of the implantable medical device ([0060]); a stimulation unit capable of generating and delivering a pulsed electrical signal comprising a plurality of microbursts to the at least one electrode ([0060]); wherein each microburst is characterized by: from 2 to 20 pulses per microburst (“each burst stimulus can comprise… about 2 to about 10 spikes”); an interpulse interval between adjacent pulses of the microburst is 50 milliseconds (“The burst stimulus comprises a frequency in the range of about… 20 Hz”; “The interval between spikes can be about 0.5 milliseconds to about 100 milliseconds”); and a microburst duration of less than 1 second (“the burst stimulus has a duration in the range of about 10 milliseconds to about 5 seconds”); and wherein each microburst is separated from an adjacent microburst by an interburst period of at least 100 milliseconds (“The inter-burst interval has a duration in the range of… about 10 milliseconds to about 300 milliseconds, or any range therebetween” [0059]).
De Ridder does not expressly disclose one or more sensors capable of sensing at least a portion of a cardiac cycle of the patient and a respiratory cycle of the patient; the implantable medical lead comprising the one or more sensors; a detection unit coupled to the one or more sensors for detecting the portion of the cardiac cycle of the patient and the respiratory cycle of the patient; and the stimulation unit capable of generating and delivering the pulsed electrical signal in response to the detection unit detecting the portion of the cardiac cycle and the respiration cycle of the patient. Haefner et al. teaches an implantable medical device for vagal stimulation where the stimulation unit of the implantable medical device is capable of generating and delivering a pulsed electrical signal in response to the detection unit detecting both a portion of the cardiac cycle and the respiratory cycle (“in addition to synchronizing neural stimulation to respiratory cycles, synchronization module 538 also synchronizes the neural stimulation to cardiac cycles” [0042]), teaching that adding consideration to the physiological cycles of the patient “provides a negative feedback to mitigate undesirable effects such as abnormally long respiratory cycle lengths caused by the neural stimulation” and “the synchronization between respiratory cycles and neural stimulation allows the neural stimulation to mimic the natural heart rate modulation by the respiration where the heart rate increases during the inspiration phase and decreases during the expiration phase” ([0042]). Haefner et al. teaches one or more sensors 426, 870 on an implantable medical lead, capable of sensing at least a portion of the cardiac cycle of the patient and a respiratory cycle of the patient ([0050-0051]), and a detection unit coupled to the one or more sensors for detecting the portion of the cardiac cycle of the patient and the respiratory cycle of the patient (fig. 8). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify De Ridder to incorporate one or more sensors on an implantable medical lead, capable of sensing at least a portion of a cardiac cycle and a respiratory cycle of the patient, and a detection unit coupled to the one or more sensors for detecting the portion of the cardiac cycle and the respiratory cycle, and to deliver the pulsed electrical signal to the at least one electrode in response to detecting the portion of the cardiac cycle and respiratory cycle of the patient as taught by Haefner et al. in order to mitigate undesirable effects caused by neural stimulation and allow the neural stimulation to mimic the natural heart rate modulation according to different stages of the cardiac and respiratory cycle ([0042]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Ridder (US 2006/0095090) in view of Haefner et al. (US 2008/0058892) and further in view of Street (US Pat 6,115,627).
Regarding claim 19, De Ridder does not expressly disclose wherein the detection unit is further configured to determine a heart rate variability (HRV) parameter, and wherein the stimulation unit is further configured to generate and deliver the pulsed electrical signal to the vagus nerve in response to the determined HRV parameter. Street teaches it is known in the art to use a high frequency component of a spectral analysis of the heart’s R-R intervals to determine the respiratory cycle (col. 1, lines 38-45). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify De Ridder to try using a high frequency component of a HRV power spectrum to determine the respiratory cycle as taught by Street as it is a well-known technique for determining such a parameter, would not alter the operation of the device, and the results of such a determination would have been reasonably predictable.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Ridder (US 2006/0095090) in view of Haefner et al. (US 2008/0058892) and Street (US Pat 6,115,627) and further in view of Shelchuk (US 2004/0199210).
Regarding claim 20, De Ridder in view of Street disclose utilizing a high frequency component of an HRV power spectrum to determine the respiratory cycle (see rejection for claim 19 above), but does not expressly disclose determining when inspiration occurs. Shelchuk teaches it is important not to deliver stimulation during the inspiration phase of a respiratory cycle, and instead to deliver the stimulation to the vagus nerve after a delay period following the inspiration period (“postinspiration”) as cardiac vagal neurons receive inhibitory synaptic input during inspiration and excitatory synaptic input during exhalation ([0149]). Shelchuk further teaches stimulation is therefore delivered postinspiration and in synchrony with cardiac events ([0132]) in order to stimulate the parasympathetic response in an excitatory manner. It would therefore have been obvious to one of ordinary skill in the art at the time the invention was made to modify De Ridder to specifically determine when inspiration of the respiratory cycle occurs as Shelchuk teaches this is an important respiratory cycle event that would alter the effectiveness of stimulating the parasympathetic response in an excitatory manner.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/ERICA S LEE/Primary Examiner, Art Unit 3796
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