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 .
Response to Arguments
Applicant’s arguments, see pages 10-11, filed on 6/02/2026, with respect to the rejection(s) of claim(s) 18-20 under nonstatutory double patenting 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 Therefore, the rejection has been withdrawn.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 Mika et al (US 10,485,658).
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.
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Claims 18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19 of U.S. Patent No. 10,485,658. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are anticipated by the claims of U.S. Patent No. 10,485,658.
Instant Application 18/610418
US Patent No. 10,485,658
Claim 18
A system for reducing blood pressure in a patient, the system comprising:
Claim 1
A system for reducing blood pressure in a patient, the system comprising:
a stimulation circuit configured to deliver a stimulation pulse to at least one cardiac chamber of a heart of the patient;
a stimulation circuit configured to deliver a stimulation pulse to at least one cardiac chamber of a heart of the patient;
a blood pressure sensor configured to sense the patient's blood pressure; and
at least one controller configured to execute delivery of one or more stimulation patterns of stimulation pulses to the at least one cardiac chamber over a time interval,
and at least one controller configured to execute the delivery of one or more stimulation patterns of stimulation pulses to the at least one cardiac chamber over a timescale interval of at least one week
wherein a first stimulation pattern of the one or more stimulation patterns reduces the blood pressure of the patient by a first reduction amount,
wherein the first stimulation pattern reduces the blood pressure of the patient by a first reduction amount,
wherein a second stimulation pattern of the one or more stimulation patterns reduces the blood pressure of the patient by a second reduction amount,
wherein the second stimulation pattern reduces the blood pressure of the patient by a second reduction amount,
wherein the first reduction amount is greater than the second reduction amount,
wherein the first reduction amount is greater than the second reduction amount, and
wherein the second reduction amount is greater than zero, and
wherein the second reduction amount is greater than zero.
wherein the second stimulation pattern comprises at least one of application of atrial kick reduction pulses at a frequency of no more than 10 pulses in a period of 20 minutes.
Claim 19
wherein the second stimulation pattern comprises at least one of application of atrial kick reduction pulses at a frequency of no more than 10 pulses in a period of 20 minutes
Claim 20
The system of claim 18, wherein the second stimulation pattern comprises alternating between one degree of blood pressure reduction and another different degree of blood pressure reduction.
Claim 19
The system of claim 1, wherein the second stimulation pattern comprises at least one of…or alternating between one degree of blood pressure reduction and another different degree of blood pressure reduction.
Allowable Subject Matter
Claim 19 is 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. Claim 19 has been amended similarly to claims 1 and 10. Reasons for the indication of allowable subject matter pertaining to claims 1 and 10 are discussed below.
The following is a statement of reasons for the indication of allowable subject matter: Examiner has not found any prior art that teaches or suggests in combination, the limitations recited in claims 1, 10, and 18.
Regarding claims 1 and 10, Examiner has not found prior art that teaches:
"...determine a first blood pressure change value based on the second value of the parameter and the first value of the parameter,
deliver a second stimulation pattern to the at least one cardiac chamber of the heart to reduce blood pressure,
receive from the sensor, during delivery of the second stimulation pattern, a third value of the parameter,
determine a second blood pressure change value based on the third value of the parameter and the first value of the parameter,
compare the second blood pressure change value to the first blood pressure change value, and
based on the comparison, adjust the second stimulation pattern to provide an adjusted blood pressure change value."
Mika et al (US 2014/0180353) discloses a loop (Fig. 8) where stimulation is delivered, parameters are sensed/analyzed, and adjustments are made to the stimulation based off of the analysis. Mika further discloses: [0166] step 604 may include the following: comparing sensed parameter values to a target; comparing sensed parameters between two or more stimulation patterns; comparing calculated values (e.g., the k constant) relating to two or more stimulation patterns; and comparing additional sensed parameters between two or more stimulation patterns. While Mika does teach comparing sensed blood pressure parameters between a first and second stimulation pattern, Mika fails to disclose determining blood pressure change values based off of that comparison and then adjusting stimulation based off of those blood pressure change values.
Regarding claim 18, Examiner has not found art that teaches “wherein a first stimulation pattern of the one or more stimulation patterns reduces the blood pressure of the patient by a first reduction amount, wherein a second stimulation pattern of the one or more stimulation patterns reduces the blood pressure of the patient by a second reduction amount, wherein the first reduction amount is greater than the second reduction amount, and wherein the second reduction amount is greater than zero, and wherein the second stimulation pattern comprises at least one of application of atrial kick reduction pulses at a frequency of no more than 10 pulses in a period of 20 minutes.”
Mika et al (US 2014/0180353) discloses delivering a first stimulation pattern ([0162] step 602), sensing a change in blood pressure after delivery of the stimulation ([0163] step 603), and adjusting first stimulation pattern to be a second stimulation pattern configured to cause a reduction in blood pressure by at least a predetermined amount ([0169] step 605), but fails to disclose wherein the first reduction amount is greater than the second reduction amount, and wherein the second reduction amount is greater than zero, and wherein the second stimulation pattern comprises at least one of application of atrial kick reduction pulses at a frequency of no more than 10 pulses in a period of 20 minutes.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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