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 repeats a substantial portion of prior Application Nos. 16/145,795 and 17/140,454, filed 9/28/18 and 1/4/21 respectively, and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Specifically claim 77-82, claim 77 recites “ a battery configured to be securely disposed within a chamber of the garment in a first locked manner and provide power to one or more electrical components on the garment; a battery lock configured to mechanically engage the battery in a second locked manner upon receiving a lock signal; and battery lock circuitry configured to transmit the lock signal to the battery lock in response to a motion signal produced by a motion sensor attached to or worn by the patient.” The issue is that the specification does not disclose the it being a chamber of the “garment” which holds the battery or the battery locking elements. Its elements of the controller holding the battery and have a locking mechanism, while the controller/device may be held or supported by the garment they are not the same thing.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “150” has been used to designate both belt Fig. 1A and Locking mechanism in Fig. 1D. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: [0072] (using the PG Pub for paragraph numbers) recites “a belt 150” while [0083] recites “cardiac monitoring device 100D that includes a battery locking mechanism 150”. The reference numbers are the same for different parts, Examiner believes the belt is mislabeled and needs to be amended.
Appropriate correction is required.
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.
Claim 77-82 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 77 recites “ a battery configured to be securely disposed within a chamber of the garment in a first locked manner and provide power to one or more electrical components on the garment; a battery lock configured to mechanically engage the battery in a second locked manner upon receiving a lock signal; and battery lock circuitry configured to transmit the lock signal to the battery lock in response to a motion signal produced by a motion sensor attached to or worn by the patient.” The issue is that the specification does not provide sufficient written description for the underlined elements. The written description does not recite it being a chamber of the “garment” which holds the battery or the battery locking elements. The written description recites it being elements of the controller holding the battery and have a locking mechanism, while the controller/device may be held or supported by the garment they are not the same thing. Applicants have not disclosed the specifics of how they achieved the “garment” performing this or having these capabilities. Therefore, the claim does not have sufficient written description. The claims depending from this claim share this issue and are likewise rejected. Examiner believes Applicants were interpreting the garment as including the “medical device controller 120” but while the system includes both they are not the same. Examiner notes if Applicants meant for the “chamber” to be a chamber within the medical device controller 120 which is itself on the “garment” amending to clarify would progress prosecution.
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.
Claim 68-76, 83-87 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10918877. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 2 of ‘877 reads on claim 68, 83-84 of the current application. Claim 3-5 of ‘877 reads on claim 69-71, 85-86 of the current application. Claim 7 of ‘877 reads on claim 72, 87 of the current application. Claim 2 of ‘877 reads on claim 76 of the current application.
Claims 68-76, 83-87 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12151118 in view of US 20150035654 to Kaib et al. (cited in IDS dated 10/22/24).
Claim 8 of ‘118 reads on all of claim 68 except that the physiological sensors include ECG electrodes coupled with the skin and gathering ECG. Kaib discloses having both motion sensors and ECG sensors ([0049], Fig. 1) on an ambulatory device providing defibrillation in response to particular arrhythmias. It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the device of claim 8 ‘118 to include ECG sensors as claim 8 recites physiological sensors on ambulatory device and including ECG provides for sensing to engage lifesaving therapy in a light weight formfactor ([0073]).
Claim 8 of ‘118 reads on 83.
Claims 8-11 of ‘118 reads on claims 69-72, 76 and 85-87.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20190140226 see fig. 1
US 20160256161 (cited in IDS dated 10/22/24) see [0262]-[0277], Figs. 30-32
US 20180014132 (cited in IDS dated 10/22/24) see [0003]-[0004], [0015]-[0018]
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES R MOSS whose telephone number is (571)272-3506. The examiner can normally be reached Monday - Friday (9:30 am - 5:30 pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571)272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James Moss/Examiner, Art Unit 3792
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