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 .
Election/Restrictions
Applicant’s election of Group 1, claims 1-10 in the reply filed on 2/18/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the accelerometer attached to a pad or lead must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
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 under 35 U.S.C. 120 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 application, Application No. 18/982,953, 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. Claim 1 requires an “accelerometer affixed on one of the leads or one of the pads” which is not explicitly disclosed in the prior-filed application. Claims 2-10 depend from claim 1 and therefore all claimed have an effective filing date of 5/30/2025.
Furthermore, the prior-filed application does not disclose:
Notifying emergency contacts of a user as recited in claim 2,
A button to select instructions as recited in claim 3,
Providing instructions for self-application as recited in claim 6,
Contacting emergency services as recited in claim 7, and
A precursor being syncope or angina, as recited in claim 8
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-10 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites that the pads “are placed on a user.” This effectively recites the human body as a structural limitation of the claims. The claims should recite the pads are “configured to be placed.” Claims 2-10 depend from claim 1 and thus are rejected by their association.
Similarly and additionally, claim 9 recites that the pads “are applied to the chest” and claim 10 recites that the adhesive “is adhered to the user’s chest.”
Specification
The disclosure is objected to because of the following informalities: the first paragraph of the specification should list all continuity data found in the ADS filed on 5/30/2025 and the current status of any application.
Appropriate correction is required.
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 4, 5 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Shaker et al. (US 11,547,863, hereinafter Shaker) in view of Hansen et al. (US 2022/0032076, hereinafter Hansen).
Regarding claims 1, 8, 9 and 10, Shaker discloses an ambulatory monitor with integrated defibrillator (i.e., an AED) as seen in figures 4 and 5. Four walls are affixed to a bottom surface and a dividing layer is affixed to the four walls to create a circuit enclosure configured to hold microcontroller circuitry 415, and to create, along with removable cover 465, an electrode enclosure configured to hold electrode pads 405 and 410 and their associated leads before they are adhesively applied to the chest of the user to collect ECG data (Col. 8, lines 32-39 and figures 4, 6 and 9 and annotated figure below)
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The pads are configured to be placed on a user, by the user, after the user experiences any cardiac arrest precursor, including syncope and angina. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. It is also noted that the claims do not require detection of angina or syncope, merely that the pads can be applied after angina or syncope occurs, which the pads of Shaker are configure to do. Shaker is silent as to their being an accelerometer affixed to one of the pads.
Hansen also discloses an ambulatory monitor with integrated defibrillator and thus is analogous art with Shaker. Hansen discloses that the electrodes pads have an accelerometer affixed to them (par. 0008, 0010, 0049 and abstract). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Shaker to include an accelerometer on the pads as taught by Hansen in order to analyze a breathing pattern of the user and initiate CPR protocol, if necessary.
Regarding claims 4 and 5, Shaker discloses the device is an automated external defibrillator (AED) that determine if a shock is needed and delivers the shock based on the determination (Col. 8, lines 32-39).
Claims 2, 3, 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Shaker and Hansen in view of Chapman et al. (US 2024/0207625, hereinafter Chapman).
Regarding claims 2, 3, 6 and 7, Shaker, as described above, discloses a defibrillator with pads but is silent as to the defibrillator notifying emergency services and emergency contacts, as well as a button for selecting and providing instructions for self-application. Chapman also discloses a defibrillator, and thus is analogous art with Shaker (par. 0017). Chapman discloses notifying emergency services and emergency contacts (par. 0044-0045), as well as a button for selecting and providing instructions for self-application (par. 0023, 0027). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Shaker to notify emergency services and emergency contacts, as well as include a button for selecting and providing instructions for self-application as taught by Chapman in order to allow a user to be treated when the are alone and without further assistance (par. 0012).
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, 4, 5 and 8-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9 and 10 of copending Application No. 19/223,747 (reference application) in view of Hansen.
Regarding claims 1, 4, 5, and 8, although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate most limitations of the current claims. The pads are configured to be placed on a user, by the user, after the user experiences any cardiac arrest precursor, including syncope and angina. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. It is also noted that the claims do not require detection of angina or syncope, merely that the pads can be applied after angina or syncope occurs, which the pads of the copending claims are configured to do. The copending claims are silent to having an accelerometer affixed to the pads. Hansen also discloses an ambulatory monitor with integrated defibrillator and thus is analogous art with the copending claims. Hansen discloses that the electrodes pads have an accelerometer affixed to them (par. 0008, 0010, 0049 and abstract). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify the copending claims to include an accelerometer on the pads as taught by Hansen in order to analyze a breathing pattern of the user and initiate CPR protocol, if necessary.
Regarding claims 9 and 10, the Examiner takes Official Notice that the use of adhesive to adhere defibrillator pads to a chest of a user it notoriously old and well known in the art before the applicant’s effective filing date.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 3, 6 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9 and 10 of copending Application No. 19/223,747 (reference application) and Hansen in view of Chapman et al. (US 2024/0207625, hereinafter Chapman).
Regarding claims 2, 3, 6 and 7, the copending claims disclose the applicant’s basic invention but is silent as to the defibrillator notifying emergency services and emergency contacts, as well as a button for selecting and providing instructions for self-application. Chapman also discloses a defibrillator, and thus is analogous art with Shaker (par. 0017). Chapman discloses notifying emergency services and emergency contacts (par. 0044-0045), as well as a button for selecting and providing instructions for self-application (par. 0023, 0027). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify the copending claims to notify emergency services and emergency contacts, as well as include a button for selecting and providing instructions for self-application as taught by Chapman in order to allow a user to be treated when they are alone and without further assistance (par. 0012).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 19/224,706 (reference application) in view of Hansen. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the current claims with the exception of having an accelerometer affixed to the pads. Hansen also discloses an ambulatory monitor with integrated defibrillator and thus is analogous art with Shaker. Hansen discloses that the electrodes pads have an accelerometer affixed to them (par. 0008, 0010, 0049 and abstract). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Shaker to include an accelerometer on the pads as taught by Hansen in order to analyze a breathing pattern of the user and initiate CPR protocol, if necessary.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 5 and 8-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/982,974 (reference application) in view of Hansen.
Regarding claims 1 and 8, although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate most of the limitations of the current claims. The pads are configured to be placed on a user, by the user, after the user experiences any cardiac arrest precursor, including syncope and angina. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. It is also noted that the claims do not require detection of angina or syncope, merely that the pads are stored with the intended use “TO monitor” and that the pads can be applied after angina or syncope occurs, which the pads of the copending claims are configured to do. The copending claims are silent to having an accelerometer affixed to the pads. Hansen also discloses an ambulatory monitor with integrated defibrillator and thus is analogous art with the copending claims. Hansen discloses that the electrodes pads have an accelerometer affixed to them (par. 0008, 0010, 0049 and abstract). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify the copending claims to include an accelerometer on the pads as taught by Hansen in order to analyze a breathing pattern of the user and initiate CPR protocol, if necessary.
Regarding claims 4, 5, 9 and 10, the Examiner takes Official Notice that the use of adhesive to adhere defibrillator pads to a chest of a user, and to use pads of a defibrillator to monitor cardiac data for a shockable rhythm, is notoriously old and well known in the art before the applicant’s effective filing date.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 3, 6 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9 and 10 of copending Application No. 18/982,974 (reference application) and Hansen in view of Chapman et al. (US 2024/0207625, hereinafter Chapman).
Regarding claims 2, 3, 6 and 7, the copending claims disclose the applicant’s basic invention but is silent as to the defibrillator notifying emergency services and emergency contacts, as well as a button for selecting and providing instructions for self-application. Chapman also discloses a defibrillator, and thus is analogous art with Shaker (par. 0017). Chapman discloses notifying emergency services and emergency contacts (par. 0044-0045), as well as a button for selecting and providing instructions for self-application (par. 0023, 0027). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify the copending claims to notify emergency services and emergency contacts, as well as include a button for selecting and providing instructions for self-application as taught by Chapman in order to allow a user to be treated when they are alone and without further assistance (par. 0012).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 5 and 8-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/982,960 (reference application) in view of Hansen.
Regarding claims 1 and 8, although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate most of the limitations of the current claims. The pads are configured to be placed on a user, by the user, after the user experiences any cardiac arrest precursor, including syncope and angina. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. It is also noted that the claims do not require detection of angina or syncope, merely that the pads are stored with the intended use “TO monitor” and that the pads can be applied after angina or syncope occurs, which the pads of the copending claims are configured to do. The copending claims are silent to having an accelerometer affixed to the pads. Hansen also discloses an ambulatory monitor with integrated defibrillator and thus is analogous art with the copending claims. Hansen discloses that the electrodes pads have an accelerometer affixed to them (par. 0008, 0010, 0049 and abstract). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify the copending claims to include an accelerometer on the pads as taught by Hansen in order to analyze a breathing pattern of the user and initiate CPR protocol, if necessary.
Regarding claims 4, 5, 9 and 10, the Examiner takes Official Notice that the use of adhesive to adhere defibrillator pads to a chest of a user, and to use pads of a defibrillator to monitor cardiac data for a shockable rhythm, is notoriously old and well known in the art before the applicant’s effective filing date.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 3, 6 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9 and 10 of copending Application No. 18/982,960 (reference application) and Hansen in view of Chapman et al. (US 2024/0207625, hereinafter Chapman).
Regarding claims 2, 3, 6 and 7, the copending claims disclose the applicant’s basic invention but is silent as to the defibrillator notifying emergency services and emergency contacts, as well as a button for selecting and providing instructions for self-application. Chapman also discloses a defibrillator, and thus is analogous art with Shaker (par. 0017). Chapman discloses notifying emergency services and emergency contacts (par. 0044-0045), as well as a button for selecting and providing instructions for self-application (par. 0023, 0027). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify the copending claims to notify emergency services and emergency contacts, as well as include a button for selecting and providing instructions for self-application as taught by Chapman in order to allow a user to be treated when they are alone and without further assistance (par. 0012).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 5 and 8-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of copending Application No. 18/982,953 (reference application) in view of Hansen.
Regarding claims 1 and 8, although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate most of the limitations of the current claims. The pads are configured to be placed on a user, by the user, after the user experiences any cardiac arrest precursor, including syncope and angina. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. It is also noted that the claims do not require detection of angina or syncope, merely that the pads are stored with the intended use “TO monitor” and that the pads can be applied after angina or syncope occurs, which the pads of the copending claims are configured to do. The copending claims are silent to having an accelerometer affixed to the pads. Hansen also discloses an ambulatory monitor with integrated defibrillator and thus is analogous art with the copending claims. Hansen discloses that the electrodes pads have an accelerometer affixed to them (par. 0008, 0010, 0049 and abstract). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify the copending claims to include an accelerometer on the pads as taught by Hansen in order to analyze a breathing pattern of the user and initiate CPR protocol, if necessary.
Regarding claims 4, 5, 9 and 10, the Examiner takes Official Notice that the use of adhesive to adhere defibrillator pads to a chest of a user, and to use pads of a defibrillator to monitor cardiac data for a shockable rhythm, is notoriously old and well known in the art before the applicant’s effective filing date.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 3, 6 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of copending Application No. 18/982,953 (reference application) and Hansen in view of Chapman et al. (US 2024/0207625, hereinafter Chapman).
Regarding claims 2, 3, 6 and 7, the copending claims disclose the applicant’s basic invention but is silent as to the defibrillator notifying emergency services and emergency contacts, as well as a button for selecting and providing instructions for self-application. Chapman also discloses a defibrillator, and thus is analogous art with Shaker (par. 0017). Chapman discloses notifying emergency services and emergency contacts (par. 0044-0045), as well as a button for selecting and providing instructions for self-application (par. 0023, 0027). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify the copending claims to notify emergency services and emergency contacts, as well as include a button for selecting and providing instructions for self-application as taught by Chapman in order to allow a user to be treated when they are alone and without further assistance (par. 0012).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796