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 .
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 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.
Status of Claims
Claims 1-20 are pending and under consideration for patentability.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 27 December 2024 has been acknowledged and considered by the Examiner.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent 12,214,212 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method for use with an implantable medical device comprising determining that a patient is experiencing atrial tachycardia or atrial fibrillation, classifying the patient’s intrinsic activity, and performing atrial pacing at a rate faster than the intrinsic rate of the patent while the patient is experiencing the atrial tachycardia or atrial fibrillation.
A brief, but non-exhaustive matching of the pending claims and the issued claims is provided via the table below.
Application No. 19/003,136
Pending Claims
U.S. Patent No. 12,214,212 B2
Issued Claims
1.
A method for use by a medical device or system implanted within a patient, the method comprising:
(a) determining that the patient is experiencing an atrial tachycardia or atrial fibrillation (AF) while an intrinsic atrial rate of the patient is within a specified range;
(b) determining a measure of dispersion of a plurality of intrinsic atrial intervals that occur while the patient is experiencing the atrial tachycardia or AF and the intrinsic atrial rate of the patient is within the specified range; and
(c) performing atrial pacing for a specified period at an atrial pacing rate that is faster than the intrinsic atrial rate of the patient while the patient is experiencing the atrial tachycardia or AF and the intrinsic atrial rate of the patient is within the specified range, in response to the measure of dispersion being below a specified threshold.
1.
A method for use by a medical device or system implanted within a patient, the method comprising:
(a) determining that the patient is experiencing an atrial tachycardia or atrial fibrillation (AF) while an intrinsic atrial rate of the patient is within a specified range;
(b) determining a measure of dispersion of a plurality of intrinsic atrial intervals that occur while the patient is experiencing the atrial tachycardia or AF and the intrinsic atrial rate of the patient is within the specified range; and
(c) performing atrial overdrive pacing while the patient is experiencing the atrial tachycardia or AF and the intrinsic atrial rate of the patient is within the specified range, to attempt convert the atrial tachycardia or AF to a normal sinus rhythm, in response to the measure of dispersion being below a specified threshold.
10.
The method of claim 1, wherein the performing atrial overdrive pacing comprises applying electrical pacing pulses to an atrium of the patient at a rate faster than the intrinsic atrial rate of the patient.
2
2
3
3
4
7
5
8
6
6
7
10
8
12
9
12
10
1, 10 (repeating method steps)
11
13, 19
12
14
13
15
14
7
15
18
16
20
17
21
18
21
19
13, 19
20
2, 3, 8
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent 11,896,839 B2 or claims 1-20 of U.S. Patent No. 10,780,288 B2 in view of Levine (US 7,328,066 B1). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method for use with an implantable medical device comprising determining that a patient is experiencing atrial tachycardia or atrial fibrillation, classifying the patient’s intrinsic activity, and performing atrial pacing while the patient is experiencing the atrial tachycardia or atrial fibrillation. The Examiner notes that the claims issued in U.S. Patent No. 11,896,839 B2 recite classifying a patient’s intrinsic activity as stable, whereas the pending claims recite a substantially equivalent step of “determining a measure of dispersion of a plurality of intrinsic atrial intervals.” The Examiner respectfully submits that “stability” is a “measure of dispersion,” and, as a result, the issued claims are not patentably distinct from the pending claims.
Regarding independent claims 1, 11, and 19, specifically the limitation of “an atrial pacing rate that is faster than the intrinsic atrial rate of the patient,” Levine also describes a method of determining and treating atrial tachycardia or atrial fibrillation, including applying pacing at a rate faster than the intrinsic atrial rate of the patient (col 1:25-29, 1:59-2:6). As Levine is also directed towards determining and treating atrial arrhythmias and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate preventative pacing and high rate pacing similar to those described by Levine when using the method recited the ‘839 and ‘288 patents, as doing so advantageously allows the resulting methods to treat a larger number of arrhythmias.
A brief, but non-exhaustive matching of the pending dependent claims and the issued claims is provided via the table below.
Application No. 19/003,136
Pending Claims
U.S. Patent No. 11,896,839 B2
Issued Claims
U.S. Patent No. 10,780,288 B2
Issued Claims
2
2
2
3
3
1
4
-
18
5
17
18
6
12
11
7
6
-
8
10
10
9
10
9
10
1 (repeating steps)
1 (repeating steps)
12
2
2
13
3
3
14
-
18
15
12
11
16
6
-
17
10
10
18
10
9
20
2, 3, 17
2, 3, 18
Statement on Communication via Internet
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“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno, can be reached by telephone at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796
Prosecution Insights