DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 33 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12,186,106. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the issued patent is an obvious variant of the instant claims.
Instant claim (18/964848)
Issued claim (US 12,186,106)
33. A wearable cardiac medical device comprising:
a garment to be disposed about a torso of a subject, the garment including a sensor disposed in the garment;
at least one ECG sensing electrode disposed in the garment; and
a controller configured to receive information from the sensor indicative of whether the garment is properly fit about the torso of the subject;
determine, based on the information from the sensor, whether a stretch of the garment is in an under stretch range, an over stretch range, or within a tolerance range between the under stretch range and the overstretch range;
receive ECG information from the at least one ECG sensing electrode;
process the ECG information from the at least one ECG sensing electrode as being acceptable in response to determining the garment is in the tolerance range; and
instruct the subject to one of tighten the garment to properly position the at least one ECG sensing electrode against the subject, launder the garment, or replace the garment with a smaller sized garment in response to determining the garment is in the under stretch range.
1. A wearable cardiac medical device comprising:
a garment to be disposed about a torso of a subject, the garment including a sensor disposed in the garment;
at least one ECG sensing electrode disposed in the garment; and
a controller configured to receive information from the sensor indicative of whether the garment is properly fit about the torso of the subject;
determine, based on the information from the sensor, whether a stretch of the garment is in an under stretch range, an over stretch range, or within a tolerance range between the under stretch range and the overstretch range;
receive ECG information from the at least one ECG sensing electrode;
process the ECG information from the at least one ECG sensing electrode as being acceptable in response to determining the garment is in the tolerance range; and process the ECG information from the at least one ECG sensing electrode as being unacceptable in response to determining the garment is in the under stretch range.
6. The wearable cardiac medical device of claim 1, wherein the controller is further configured to, responsive to determining the garment is in in the under stretch range, instruct the subject to one of tighten the garment, launder the garment, or replace the garment.
48. A non-transitory computer readable medium storing a sequence of instructions that, when executed by a controller of a wearable cardiac medical device that includes a garment disposed about a body of a subject, cause the controller to:
receive information from a sensor disposed in the garment indicative of whether the garment is properly fit about the torso of the subject;
determine, based on the information from the sensor, whether a stretch of the garment is in an under stretch range, an over stretch range, or within a tolerance range between the under stretch range and the overstretch range;
receive ECG information from at least one ECG sensing electrode disposed in the garment;
process the ECG information from the at least one ECG sensing electrode as being acceptable in response to determining the garment is in the tolerance range; and
instruct the subject to one of tighten the garment to properly position the at least one ECG sensing electrode against the subject, launder the garment, or replace the garment with a smaller sized garment in response to determining the garment is in the under stretch range.
1. A wearable cardiac medical device comprising:
a garment to be disposed about a torso of a subject, the garment including a sensor disposed in the garment;
at least one ECG sensing electrode disposed in the garment; and
a controller configured to receive information from the sensor indicative of whether the garment is properly fit about the torso of the subject;
determine, based on the information from the sensor, whether a stretch of the garment is in an under stretch range, an over stretch range, or within a tolerance range between the under stretch range and the overstretch range;
receive ECG information from the at least one ECG sensing electrode;
process the ECG information from the at least one ECG sensing electrode as being acceptable in response to determining the garment is in the tolerance range; and process the ECG information from the at least one ECG sensing electrode as being unacceptable in response to determining the garment is in the under stretch range.
6. The wearable cardiac medical device of claim 1, wherein the controller is further configured to, responsive to determining the garment is in in the under stretch range, instruct the subject to one of tighten the garment, launder the garment, or replace the garment.
Regarding claim 48, the claim of the issued patent does not expressly indicate that the controller operates via a non-transitory computer-readable medium. However, it is notorious in the art of electrical therapy devices to provide control via controllers coupled to non-transitory computer-readable media to provide the predictable results of effectuating control with ubiquitous digital technology that utilizes off-the-shelf hardware. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the subject matter of the issued claims by providing control via a controller coupled to a non-transitory computer-readable media to provide the predictable results of effectuating control with ubiquitous digital technology that utilizes off-the-shelf hardware.
Allowable Subject Matter
Claims 33-52 avoid the prior art, but a double-patenting rejection is set forth above. Claims 34-47 and 49-52 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 a statement of reasons for the indication of allowable subject matter: the closest prior art is to Heilman et al. (US 4,928,690) and Watson et al. (US 4,308,872). Heilman discloses a garment-based ECG monitoring device, and Watson discloses the general concept of sensing stretch in a garment-based monitoring system. However, neither reference alone or in combination with the remaining prior art discloses or fairly renders unpatentable the combination of elements set forth, including a controller/computer medium to cause a controller to determine whether a stretch of the garment is in an under stretch range, an over stretch range, or within a tolerance range in between the two and in response process the ECG information as being acceptable if in the tolerance range and instruct the subject to one of tighten the garment to properly position the electrode, launder the garment, or replace the garment with a smaller size in response to determining the garment is in the under stretch range.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Oskin et al. (US 10,926,098) is a teaching of a wearable cardiac device with an alarm to indicate incorrect electrode placement (col. 8, lines 23-67), but lacks the specific functionality recited in the claims of processing ECG and instructing the subject conditional on determined stretch ranges.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
