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 Arguments
Applicant’s arguments combined with the claim amendments have been fully considered but are not found persuasive. Although applicant amended the claims to resolve the priority issues, the revised claim language continues to fail to be supported and is not awarded a priority date which would result in Stickney being unavailable. No arguments against the prior rejection were made and the claims continue to remain rejected under Kaib in view of Stickney. Any updated grounds of rejection below are due to the claim amendments.
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 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-21 of U.S. Patent No. 11,291,396; Claims 1-20 of U.S. Patent No. 10,813,566; Claims 1-21 of U.S. Patent No. 10,219,717; Claims 1-20 of U.S. Patent No. 9,408,548; and Claims 1-23 of U.S. Patent No. 8,897,860. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the present claims are obvious variants of the patented invention in the parent cases.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 16/671,821, 16/241,119, 15/205,584, 14/536,189, 13/428,329, 61/467,599, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, newly amended claim 21 recites the phrase “cause therapy to be delivered (to) the patient based upon the analysis of the at least one ECG signal”. This phrase in combination with the other limitations in the claim, fails to be supported by the disclosure of these prior-filed applications. A therapy delivery interface is mentioned, but there is no discussion of “causing therapy to be delivered to the patient” in the specification – and more especially not therapy to be delivered to the patient “based upon the analysis of the at least one ECG signal” as explicitly claimed.
Accordingly, the present application is assigned a priority date of 28 February 2022.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Newly amended claim 21 recites the phrase “cause therapy to be delivered (to) the patient based upon the analysis of the at least one ECG signal”. This phrase in combination with the other limitations in the claim, fails to be supported by the disclosure as originally filed. A therapy delivery interface is listed in ¶¶ 33, but there is no discussion of “causing therapy to be delivered to the patient” in the specification – and more especially not therapy to be delivered to the patient “based upon the analysis of the at least one ECG signal” as explicitly claimed. In order to overcome this rejection, it is suggested to amend the claim language to fall within the scope of the disclosure as originally filed, or indicate where support lies for these limitations.
Claims 22-40 are rejected under the same rationale as being dependent upon claim 21 and its limitations.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Newly amended claim 21 recites the phrase “cause therapy to be delivered (to) the patient based upon the analysis of the at least one ECG signal”; however, it is unclear and indefinite what is the “therapy to be delivered” to the patient, and what would fall within the scope of “cause therapy to be delivered”. For example, it is unclear whether this phrase can be interpreted as a medical professional directing a patient for a follow up for massage therapy or whether this is stimulation therapy delivered by the defibrillator in the preamble? Furthermore, it is unclear what aspect of the ECG signal is being analyzed prior to this step. Further clarification is required.
Claims 22-40 are rejected under the same rationale as being dependent upon claim 21 and its limitations.
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 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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.
Claims 21-40 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kaib et al. (US 2011/0288605; hereinafter “Kaib”) in view of Stickney et al. (US 2014/0148718; hereinafter “Stickney”).
Regarding claim 21, Kaib discloses a wearable cardiac defibrillator comprising: a plurality of electrodes disposed about a patient, the plurality of electrodes comprising a an ECG channel (e.g. Fig. 1); and a control unit comprising a sensor interface coupled to the plurality of electrodes and configured to receive ECG signals from the patient via the plurality of electrodes, a memory configured to store a set of information indicating an identified ECG channel, and at least one processor coupled to the sensor interface and the memory (e.g. Fig. 4 – all components present) and configured to establish the set of information for a first and second ECG channel, store the set of information in the memory determine, based upon the set of information, the identified ECG channel, acquire at least one ECG signal from the ECG channel (e.g. ¶¶ 89-90, 97 – where the plurality of ECG channels are analyzed and the highest quality channel is determined), analyze by a cardiac function analyzer, the at least one ECG signal (e.g. ¶¶ 107-108 – “the additional or different pairings of ECG sensing electrodes that are selected in act 740 may be one or more of those pairings that provides the next highest signal quality level other than those that were selected in act 540 of FIG. 5. In act 750, the at least one processor continues to monitor and analyze the selected ECG signals, including those from additional or different pairings of ECG sensing electrodes selected in act 740”), and cause therapy to be delivered to the patient based upon the analysis of the at least one ECG signal (e.g. ¶¶ 109 – “the cardiac arrhythmia being a type of cardiac arrhythmia for which defibrillation is an appropriate treatment, the at least one processor 410 may execute one or more instructions that result in defibrillation being applied to the body of the patient via the therapy delivery interface 416”).
Kaib fails to expressly disclose the information for the ECG channels are established based upon information received from a physician; however, the examiner notes that the present specification indicates that the information received from the physician is simply accomplished by noticing “that the amplitude or signal to noise ratio of a particular channel is superior” (¶¶ 48 of published app). This is performed in Kaib (e.g. ¶¶ 89-90, 97) where the plurality of ECG channels are analyzed and the highest quality channel is selected based on the signal-to-noise ratio; accordingly, the examiner is of the position that it would have been obvious to receive the information from the physician since it accomplishes the same result and involves only routine skill in the art.
It is unclear as to whether the first and second ECG channels relied upon in Kaib are equivalent to the first and second ECG channels claimed in the present invention. In the same field of endeavor, Stickney discloses the notorious and well known use of a first and second ECG signals - specifically front-to-back and side-to side (AKA Horizontal and Frontal plate ECG) in analyzing signals for arrhythmia in order to provide defibrillation therapy effectively (e.g. ¶¶ 71-75). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date to incorporate the use of first and second front-to-back and side-to-side ECG channels, as taught by Stickney, to the known device of Kaib, in order to yield the predictable results of providing a multi-vector approach to analyzing cardiac rhythm.
Regarding claim 22, Stickney as referenced above, obviates the step to establish the set of information for the first ECG channel and the second ECG channel comprises to rank the first ECG channel and the second ECG channel (e.g. ¶¶ e.g. ¶¶ 71-75).
Regarding claim 23, Stickney as referenced above, obviates the first ECG channel comprises a front-to-back channel and the second ECG channel comprises a side-to-side channel (e.g. ¶¶ 71-75).
Regarding claim 24, Stickney as referenced above, obviates the step to determine the identified ECG channel comprises to identify a highest ranking channel (e.g. ¶¶ 71-75).
Regarding claim 25, Kaib discloses a network interface, wherein to establish the set of information for the first ECG channel and the second ECG channel comprises to establish the set of information via the network interface (e.g. ¶¶ X).
Regarding claim 26, Kaib discloses to establish the set of information for the first ECG channel and the second ECG channel comprises to rank the first ECG channel and the second ECG channel (e.g. ¶¶ 94).
Regarding claim 27, Stickney as referenced above, obviates the first ECG channel comprises a front-to-back channel and the second ECG channel comprises a side-to-side channel (e.g. ¶¶ 71-75).
Regarding claim 28, Stickney as referenced above, obviates the step to determine the identified ECG channel comprises to identify a highest ranking channel (e.g. ¶¶ 71-75).
Regarding claim 29, Kaib discloses a garment that is configured to be worn about the patient, wherein the plurality of electrodes is integrated into the garment (e.g. ¶¶ 12).
Regarding claim 30, Kaib discloses the plurality of electrodes includes adhesive electrodes (e.g. ¶¶ 65).
Regarding claim 31, Kaib discloses to monitor the at least one ECG signal comprises to monitor a heart rate of the patient (e.g. ¶¶ 111).
Regarding claim 32, Kaib discloses to monitor the heart rate of the patient comprises to utilize one or more of a QRS detector, a spectrum analyzer, or an axis analyzer (e.g. ¶¶ 111).
Regarding claim 33, Kaib discloses a user interface, wherein to establish the set of information for the first ECG channel and the second ECG channel comprises to establish the set of information via the user interface (e.g. ¶¶ 111).
Regarding claim 34, Kaib discloses to establish the set of information for the first ECG channel and the second ECG channel comprises to rank the first ECG channel and the second ECG channel (e.g. ¶¶111).
Regarding claim 35, Stickney as referenced above, obviates the first ECG channel comprises a front-to-back channel and the second ECG channel comprises a side-to-side channel (e.g. ¶¶ 71-75).
Regarding claim 36, Stickney as referenced above, obviates the step to determine the identified ECG channel comprises to identify a highest ranking channel (e.g. ¶¶ 71-75).
Regarding claim 37, Kaib discloses a garment that is configured to be worn about the patient, wherein the plurality of electrodes is integrated into the garment (e.g. ¶¶ 12).
Regarding claim 38, Kaib discloses the plurality of electrodes includes adhesive electrodes (e.g. ¶¶ 65).
Regarding claim 39, Kaib discloses to monitor the at least one ECG signal comprises to monitor a heart rate of the patient (e.g. ¶¶ 111).
Regarding claim 40, Kaib discloses to monitor the heart rate of the patient comprises to utilize one or more of a QRS detector, a spectrum analyzer, or an axis analyzer (e.g. ¶¶ 111).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796