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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/5/2026 has been entered.
Response to Arguments
The applicant presented no arguments against the Double Patenting rejections. The rejections are still considered proper.
The objection to claim 5 has been withdrawn as the offending language was previously cancelled from the claim.
Applicant's arguments filed 2/5/2026 regarding the 102 rejections of claims 2 and 18 have been fully considered but they are not persuasive. Applicant argues that the Examiner’s interpretation of “predetermined time period” is unreasonable. However, the applicant’s original specification never explicitly uses the phrase “predetermine time period.” The phrase “tolerance time” appears to be equivalent to the claimed “predetermined time period.” Paragraph [84] of the original specification states that the “tolerance time” is any amount time that a WCD system would tolerate neither analyzing the patient, nor alerting them. Therefore, the Examiner’s interpretation is perfectly in line with the applicant’s original specification, as during the period of time of the noise determination test, the WCD system of Sullivan does not perform the shock criterion test (“analyzing the patient”) nor does it provide any alerts.
The claims DO NOT recite that the time period is fixed or is a specific temporal duration, as argued by the applicant. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
All previous rejections are still considered proper and new claims 25 and 26 are addressed below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“support structure” in claim 18, which encompasses the structures discloses in par. 24 of the original specification.
“energy storage module” in claim 18, which is a capacitor as disclosed in par. 56 of the original specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 2 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,103,717. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims disclose all limitations of the current claims, but do not explicitly disclose delaying the determination of a shock criterion until identifying if a high-amplitude noise criterion is met. However, claim 1 of the ‘717 patent discloses that the shock should be discharged ONLY when the noise detection has been completed, even if the shock criterion is met. Therefore, it makes no sense to determine if the shock criterion is met before performing the noise detection, as it makes no difference if the shock criterion is met if there is noise in the signal. Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to save battery and processing power by delaying shock determination until noise determination is compete, as suggested by the patented claims.
Claims 2, 5, 7-18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,023,510. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims disclose all limitations of the current claims, but do not explicitly disclose delaying the determination of a shock criterion until identifying if a high-amplitude noise criterion is met. However, claim 1 of the ‘510 patent discloses that the shock should be discharged ONLY when the noise detection has been completed, even if the shock criterion is met. Therefore, it makes no sense to determine if the shock criterion is met before performing the noise detection, as it makes no difference if the shock criterion is met if there is noise in the signal. Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to save battery and processing power by delaying shock determination until noise determination is compete, as suggested by the patented claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 2, 5, 7, 13, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sullivan et al. (US 2015/0328472, hereinafter Sullivan).
Regarding claims 2 and 18, Sullivan discloses a WCD with support structure 170, an energy storage module 250, a discharge circuit 255 and electrodes 204/208 (figures 1 and 2). Sullivan discloses sensing ECG signals from the electrodes while the patient is wearing the support structure (par. 0043-0044). Sullivan discloses determining if at least one segment of the ECG signal meet a high-amplitude noise criterion and discarding that signal(s). A shock criterion test is delayed until the noise criterion test is performed (i.e., a predetermined time). When at least one segment of the ECG signal meets the noise criterion and is discarded and at least one segment of the ECG signal does not meet the criterion and is not discarded, then the shock criterion test is performed and if a shock criterion is determined to be met, then a shock is delivered (see abstract, par. 0007, 0044, 0071, 0095).
Regarding claims 7 and 13, the high-amplitude noise criterion is met when at least one portion has an amplitude high enough to be indicative of noise but not high enough to register as an R-wave (par. 0087).
Regarding claims 5 and 20, Sullivan discloses that the user interface displays what is detected, which would include any ECG meeting the noise criterion (par. 0031).
Allowable Subject Matter
Claims 8-12 and 14-17 would be allowable if Terminal Disclaimers were filed to overcome the double patenting rejections set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 3, 19, 25 and 26 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.
Claims 22-24 are allowed.
Conclusion
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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/Eric D. Bertram/Primary Examiner, Art Unit 3796