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 .
Priority
This application claims benefit as a divisional application to prior Application No. 17/193,924, filed August 21, 2020. However, the claims of the application under examination and claims of the prior application/patent are not consonant with the restriction requirement made by the examiner, since the claims have been changed in material respects from the claims at the time the requirement was made. For example, the divisional application filed includes additional claims not consonant in scope with the original claims subject to restriction in the parent. Symbol Technologies, Inc. v.Opticon, Inc., 935 F.2d 1569, 19 USPQ2d 1241 (Fed. Cir. 1991); Gerber Garment Technology, Inc. v. Lectra Systems, Inc., 916 F.2d 683, 16 USPQ2d 1436 (Fed. Cir. 1990). In order for consonance to exist, the line of demarcation between the independent and distinct inventions identified by the examiner in the requirement for restriction must be maintained. 916 F.2d at 688, 16 USPQ2d at 1440. Therefore the prohibition of nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply.
Response to Amendment
The amendment filed January 16, 2025 has been entered. Claims 15, 18-19, 23-25, 28 have been amended. Claims 1-14, 17, 20-22, 26-27, 29 are canceled. Claims 30-39 are new. Currently, claims 15-16, 18-19, 23-25, 28, 30-39 are pending for examination.
Specification
The disclosure is objected to because of the following informalities: paragraph [01] should be amended to reflect U.S. Patent Application No. 17/193,924 is now U.S. Patent No. 12,226,219.
Appropriate correction is required.
Claim Objections
Claim 38 is objected to because of the following informalities: line 2 recites, “satisfies and R-R stability criterion” and should instead state, “satisfies an R-R stability criterion”. Appropriate correction is required.
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 15-16, 18-19, 25, 28, 30-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,226,219 in view of Freeman et al. (US 2018/0272147). Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims, while directed to an apparatus, are not patentably distinct from the method claims with respect to the processor limitations. While the apparatus claims recite a wearable cardioverter defibrillator comprising a support structure and a discharge circuit, these components are known in the art as taught by Freeman et al. and would not be patentable over the prior art.
Application claim
Patented claim
Reason
15, 30
1
See reason explained above
16, 31
2
Limitations are similar
18, 32
3
Limitations are similar
19
4
Limitations are similar
25
5
Limitations are similar
28
6
Limitations are similar
33
7
Limitations are similar
34
8
Limitations are similar
35
9
Limitations are similar
Claim Interpretation
Consistent with the well-established axiom in patent law that a patentee or applicant is free to be his or her own lexicographer, a patentee or applicant may use terms in a manner contrary to or inconsistent with one or more of their ordinary meanings if the written description clearly redefines the terms. See, e.g., Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “Feature Correlation Coefficient (FCC)” recited in the claims has been defined by the specification and will be considered as:
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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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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) 15-16, 18-19, 23-25, 28, 30-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. (US 2018/0272147) in view of Cohen et al. (US 2010/0189701) and Ettori et al. (US 7,890,170).
Regarding claims 15-16, 30-31, Freeman et al. discloses a wearable cardioverter defibrillator (WCD) (fig. 1), comprising: a support structure 110 wearable by a patient; a processor 120 coupled to the support structure; and a discharge circuit 402 configured to discharge a stored electrical charge through a body of the patient, the discharge circuit in communication with the processor (fig. 4); the processor configured to receive a first electrocardiogram (ECG) signal ([0030]); receive a second ECG signal ([0030]); detect a first QRS complex in the first ECG signal ([0133-0134]); detect a second QRS complex in the second ECG signal ([0133-0134]); provide therapy to a heart of the patient based, at least in part, on information detected by the QRS complexes and a determination that an episode of SVT is detected ([0106], [0133]).
While Freeman et al. discloses SVT are of particular concern ([0106]), the prior art does not expressly disclose how SVT is detected, such as the processor is configured to calculate a Feature Correlation Coefficient (FCC) based, at least in part, on the first QRS complex and the second QRS complex; determine that the first ECG signal and the second ECG signal are indicative of an episode of sustained ventricular tachycardia (SVT) based, at least in part, on the calculated FCC. Cohen et al. teaches detection of SVT is defined as the occurrence of repetitive complexes of ventricular origin with a uniform QRS morphology lasting longer than 30s ([0252]). Ettori et al. teaches it is known in the art to use FCC to determine a similarity score between beats (col. 6, lines 29-30). Ettori et al. teaches the morphology of the amplitude and timing features of QRS complexes are determined using FCC methods and checked against a threshold to determine the degree of similarity to determine cardiac episodes (col. 12, lines 10-43; col. 12, line 58 to col. 13, line 18). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Freeman et al. to determine episodes of SVT through the detection of similar QRS morphology between beats as taught by Cohen et al., by calculating an FCC based, at least in part, on a similarity score between beats such as the QRS complexes of a first ECG signal and a second ECG signal as taught by Ettori et al., as determination of SVT through the determination of similar QRS morphology is known in the art, as well as the use of FCC to determine similar features of QRS complexes, the results of such a modification being predictable in the art.
Regarding claims 18, 32, Freeman et al. in view of Ettori et al. discloses wherein the QRS criterion is a temporary QRS template of two sequential incoming QRS complexes (col. 12, lines 10-43; col. 12, line 58 to col. 13, line 18).
Regarding claim 19, Freeman et al. in view of Ettori et al. discloses wherein the processor is further configured to: determine similarity between the temporary QRS template and at least two subsequent QRS complexes by calculating the FCC between the temporary QRS template and the subsequent QRS complexes (col. 12, lines 10-43; col. 12, line 58 to col. 13, line 18).
Regarding claim 23, Freeman et al. in view of Cohen et al. discloses wherein a series of detected QRS signals has a similar calculated QRS morphology ([0252]).
Regarding claim 24, Freeman et al. in view of Ettori et al. discloses wherein the QRS morphology is calculated using the FCC of at least two incoming sequential QRS complexes (col. 12, lines 10-43; col. 12, line 58 to col. 13, line 18).
Regarding claim 25, Freeman et al. in view of Ettori et al. disclose wherein the episode of SVT is detected, at least in part, when a series of detected QRS complexes comprising the firs QRS complex and/or the second QRS complex has a similar normal sinus rhythm (NSR) morphology ([0098]).
Regarding claim 28, Freeman et al. discloses wherein the processor is further configured to store the episode of SVT based, at least in part, on the determination ([0048], [0052], [0120], [0126-0127]).
Regarding claim 33, Freeman et al. discloses a wearable medical device (fig. 1), comprising: a support structure 110 wearable by a patient; a processor 120 coupled to the support structure; and a discharge circuit 402 configured to discharge a stored electrical charge through a body of the patient, the discharge circuit in communication with the processor (fig. 4); the processor configured to: process at least one electrocardiogram (ECG) signal received from an external electrode ([0030]); generate a temporary QRS template of two sequential incoming QRS complexes from the ECG signal (col. 12, lines 10-43; col. 12, line 58 to col. 13, line 18); categorize an episode as potential non-sustained ventricular tachycardia (NSVT) based ,at least in part, on the similarity between the temporary QRS template and the at least two subsequent QRS complexes ([0134-0137], [0139]); store any episode of potential NSVT ([0048], [0052], [0120], [0126-0127]); and a determination of the risk of sustained ventricular tachycardia (SVT) resulting in providing therapy for treatment of a heart of the patient ([0106], [0133]).
While Freeman et al. discloses SVT are of particular concern ([0106]), the prior art does not expressly disclose how SVT is detected, such as the processor is configured to determine a similarity between the temporary QRS template and at least two subsequent QRS complexes by calculating a Feature Correlation Coefficient (FCC) between the temporary QRS template and the at least two subsequent QRS complexes; access the categorized episode of potential NSVT to determine a risk for the patient to develop SVT. Cohen et al. teaches detection of SVT is defined as the occurrence of repetitive complexes of ventricular origin with a uniform QRS morphology lasting longer than 30s, and runs of 3 or more repetitive complexes that terminate spontaneously before the 30s is defined as NSVT ([0252]), therefore teaching that SVT is simply a longer duration of repetitive complexes of NSVT. Ettori et al. teaches it is known in the art to use FCC to determine a similarity score between beats (col. 6, lines 29-30). Ettori et al. teaches the morphology of the amplitude and timing features of QRS complexes are determined using FCC methods and checked against a threshold to determine the degree of similarity to determine cardiac episodes (col. 12, lines 10-43; col. 12, line 58 to col. 13, line 18). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Freeman et al. to determine a similarity between the temporary QRS template and at least two subsequent QRS complexes by calculating a Feature Correlation Coefficient (FCC) between the temporary QRS template and the at least two subsequent QRS complexes as taught by Ettori et al. as the use of FCC to determine similar features of QRS complexes is known in the art, and to access the categorized episode of potential NSVT to determine a risk for the patient to develop SVT as taught by Cohen et al. since the prior art teaches SVT is simply a longer duration of repetitive complexes of NSVT, the results of such a modification being predictable in the art.
Regarding claim 34, Freeman et al. in view of Cohen et al. disclose wherein the episode of potential NSVT is categorized based, at least in part, on when an NSVT time duration and a QRS criterion are satisfied ([0252]).
Regarding claim 35, Freeman et al. in view of Cohen et al. disclose wherein the NSVT time duration is between 5 seconds and 15 seconds ([0252]).
Claim(s) 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. (US 2018/0272147) in view of Cohen et al. (US 2010/0189701) and Ettori et al. (US 7,890,170) and further in view of Soykan et al. (US 2019/0017120).
Regarding claim 36, Freeman et al. in view of Cohen et al. disclose wherein the episode of potential NSVT exceeds an NSVT time threshold ([0252]) but does not expressly disclose the NSVT exceeds a heart rate threshold. Soykan et al. teaches it is known in the art that an NSVT episode is defined by three or more consecutive heart beats at a rate in excess of 120 bpm, and lasting less than 30 seconds ([0173]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that an episode of potential NSVT would exceed a heart rate threshold of 120 bpm as evidenced by Soykan et al. as the prior art teaches these are known criteria for detecting NSVT.
Regarding claim 37, Soykan et al. does not expressly disclose the heart rate threshold is 170 bpm, but teaches heart rates in excess of 120 bpm ([0173]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to select a heart rate threshold as 170 bpm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 38-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. (US 2018/0272147) in view of Cohen et al. (US 2010/0189701) and Ettori et al. (US 7,890,170) and further in view of Ghanem (US 2010/0113889).
Regarding claim 38, Freeman et al. does not expressly disclose wherein the episode of potential NSVT satisfies an R-R stability criterion. Ghanem teaches it is known in the art to determine R-R data to indicate a potential NSVT ([0070]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Freeman et al. to use R-R stability criterion to determine NSVT as taught by Ghanem as it is a known technique for determining these kinds of episodes, the results of such a modification being reasonably predictable.
Regarding claim 39, Freeman et al. in view of Ghanem disclose determining a R-R stability criterion from a difference between at least two consecutive R-R intervals ([0066], [0097]) but does not expressly disclose the difference is less than 20 milliseconds. It would have been obvious to one having ordinary skill in the art at the time the invention was made to select a difference in R-R intervals as less than 20 milliseconds, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
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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