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 .
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, 6, 8 and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,980,471 in view of Hwang (Pub. No. 2020/0315480). Although the claims at issue are not identical, they are not patentably distinct from each other because the present invention's claims are –except as discussed below-- broader in scope than the patented claims. Once the applicant has received a patent for a species or a more specific embodiment, he is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)).
Regarding claims 1 and 2, while the ‘471 invention does not elaborate on the use of first and second electrodes on one side of a main measurement unit and a sub measurement unit on a rear surface of the main measurement unit, Hwang teaches the advantages of such an arrangement as elaborated below in the rejection of claim 1 under §103. To enhance portability, convenience and battery life, one of ordinary skill in the art would have thus considered use of such a feature to be obvious in the ‘471 invention.
Regarding claim 3, the more specific magnetic force coupling of patented claim 7 is considered to allow for the coupling or separation of the main measurement unit and the sub measurement unit.
Regarding claim 4, patented claim 9 is considered to present a specific embodiment where the third electrode is not used (i.e., the electrode is considered to be in a non-measurable state) when the electrode is stored (i.e., coupled) to the main measurement unit.
Claims 6, 8 and 11-13 clearly map to the patented claims.
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.
Claims 1-4, 6, 8 and 11-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim(s) recite(s) the mentally performable (or with pen and paper) task of determining whether each electrode is in a measurable state based on the quality of the respective electrical signal; calculating different types of electrocardiogram leads based on the number of electrodes in the measurable state and an attachment position of the electrodes in a measurable state; and calculating a changed type of electrocardiogram lead based on a changed number of electrodes in the measurable state or a changed attachment position of the electrodes, when the number of electrodes is changed during the electrocardiogram measurement. Such a task involves observation (reviewing the position of the electrodes along with the quality of ECG signals collected at any given electrode), judgement (determining whether each electrode is in a measurable state based on quality) and analysis (performing addition, subtraction and simple division to obtain the various Leads I, II, III, etc.).
This judicial exception is not integrated into a practical application because there are no improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a), because the electrodes, processors and associated units function in their usual capacity; there is no application or use of
a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition, but only monitoring – see Vanda Memo; there is no application of the judicial exception with, or by use of, a particular machine because the individual components and their combination is generic, as discussed in MPEP 2106.05(b); there is no transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c), but only data manipulation; and there is no application or use of the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the particular technological environment of portable cardiac monitoring, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the electrodes of the main and sub measurement units are generic and function in their usual capacity of collecting ECG data. Their presence would be required in any standard ECG monitoring system and are thus considered to represent insignificant data gathering activity. The generic one or more processors likewise function in their usual capacity to process data, and would be required in any computerized ECG monitoring system. The act of measuring an electrocardiogram by receiving electrical signals from the electrodes is considered insignificant data gathering that would be required in any ECG monitoring system. The combination of the electrodes, the one or more processors and the collection of ECG data is the basic requirement of any ECG monitoring system. It is noted that the arbitrarily designated main measurement unit and the sub measurement unit function merely to house the one or more processors and as a surface to attach any given electrode. Such a housing would be required in any portable electrocardiogram measuring device, with the particular electrode arrangement allowing for the LA, RA and a leg or abdominal region to be contacted, thus forming an Einthoven triangle in order to generate various standardized ECG leads.
Furthermore, the use of generic first, second and third electrodes to collect an ECG signal is WURC in the art of cardiac signal monitoring, with such an arrangement (Einthoven’s triangle) being in use for well over 120 years. The use of one or more generic processors is also WURC as it would inherently be required in any computerized ECG monitoring system. The applicant discloses that any suitable system for processing the signals may be used, including well-known devices such as a microprocessor, a CPU, an ASIC, etc.. The use of units to contain the components (i.e., a housing) is also WURC as every ECG device as a matter of practicality would require such structure in order to protect both the components within as well as the user, and to serve as a base for electrode attachment. The combination of first, second and third electrodes along with one or more processors and a housing/measurement unit(s) is also WURC as such an arrangement forms the basic building blocks of any computerized portable ECG monitor.
Regarding claim 2, the positioning of the electrodes on the main measurement unit represents insignificant extra-solution activity related to data gathering. It is WURC in the art to space ECG electrodes on either side of a portable housing in order to maintain adequate electrical and spatial separation when contacted by a user.
Claims 3, 4, 11 and 12 contain no new additional elements.
Regarding claim 6, the use of a wet electrode or a dry electrode is only nominally related to the abstract idea of calculating different types of leads. As these are the only two options for portable electrocardiogram measuring device electrodes, any third electrode must inherently be one or the other. Wet and dry electrodes are also WURC in the ECG monitoring art.
Regarding claim 8, the additional element of the generic network unit for wireless data communication represents insignificant extra-solution activity only nominally related to the abstract idea. The applicant discloses that such network units may employ a variety of standardized technologies including wireless LAN, Bluetooth and the like (p. 10, lines 4-11). The network unit is thus considered WURC.
Regarding claim 13, the generic output unit represents insignificant data outputting activity. All uses of the electrocardiogram measuring device would require such output to convey the results to a user in human perceivable form. The use of an output unit is WURC for the same reason.
Claim Rejections - 35 USC § 103
Claim(s) 1-4, 6, 8 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Albert (Pub. No. 2021/0267525) in view of Acquista (Pub. No. 2007/0293774) and Hwang (Pub. No. 2020/0315480).
Regarding claim 1, Albert discloses a portable electrocardiogram measuring device 100 for calculating one or more electrocardiogram leads (par. 0026), the device comprising: a main measurement unit comprising a first electrode (104, 404 or the like), a second electrode (106, 406 or the like), and one or more processors (par. 0005); and a sub measurement unit comprising a third electrode (108, 408 or the like); wherein the one or more processors measure an electrocardiogram, by receiving electrical signals from at least two electrodes in a measurable state and by calculating different types of electrocardiogram leads based on the number of electrodes in the measurable state and an attachment position of the electrodes in the measurable state (pars. 0026-0033, 0065, 0066, 0088), wherein the one or more processors calculate a changed type of ECG lead based on a changed number of electrodes in the measurable state or a changed attachment position of the electrodes, when the number of electrodes in the measurable state or the attachment position of the electrodes is changed during the ECG measurement (pars. 0026-0033, 0065, 0066, and 0088).
Albert does not explicitly discuss the newly added limitation pertaining to determining a quality of an electrical signal received from each electrode to determine whether each electrode is in a measurable state based on the quality of the respective electrical signal. As discussed by the applicant in the Remarks dated March 26, 2025, Albert recognizes a changed state of the electrodes via a sensor and does not disclose the feature of receiving electrical signals from each electrode to determine the signal quality.
Acquista, however, in a substantially related portable ECG measuring device, discloses that one may monitor the quality (e.g., S/N ratio) of an electrical signal in addition to monitoring if the electrode is functional (see Fig. 7, pars. 0016, 0025, etc.). Such a procedure allows the highest quality signals to be utilized in the measurement process, thus enhancing the device’s accuracy. Artisans of ordinary skill in the art would have thus considered such a feature to be obvious to adopt.
Regarding the newly added limitation regarding the calculation of a changed type of ECG lead based on a changed number of electrodes in the measurable state or a changed attachment position of the electrodes, when the number of electrodes in the measurable state or the attachment position of the electrodes is changed during the ECG measurement, Albert discloses that the lead type may be changed depending on the number of electrodes that are in a measurable state or a changed attachment position of the electrodes, when the number of electrodes in the measurable state or the attachment position of the electrodes is changed during the ECG measurement (par. 0066, where various Leads may be sensed depending on which electrodes are being contacted). While Albert does not explicitly disclose monitoring the quality of respective electrical signals to determine whether each electrode is in a measurable state, as argued above, Acquista teaches that one may –in addition to detecting the functionality of the electrode—monitor the signal quality (e.g., S/N ratio) of each electrode to determine its measurement state. Artisans of ordinary skill in the art desiring the highest quality of signals to be utilized in the measurement process –an art recognized goal for any ECG monitor— and given the teachings of Acquista, would have therefore considered it obvious to include a signal quality check in the Albert system as a part of the process for determining whether a given electrode is in a measurable state.
Finally, while Albert discloses that the electrodes may be positioned on any surface of the main measurement unit (pars. 0006, 0082), and discloses the use of a sub measurement unit 408 on a rear surface of the main measurement unit (see Figs. 4A, 4B), Albert does not explicitly disclose first and second electrodes on a front surface of the main measurement unit. Hwang, however, in a substantially related device, discloses such an arrangement (see Fig. 1; par. 0037). Hwang additionally teaches that, unlike devices such as disclosed by Albert (see par. 0021 which references Thomson ‘660, of which Albert is a co-inventor), by using a stand-alone main/sub measurement unit, such an electrode arrangement allows for accurate simultaneous lead measurements, while permitting the device to be compact and conveniently carried without the need for a display (par. 0004). Artisans of ordinary skill in the art looking to enhance convenience and portability without the need for a specially manufactured smartphone or smartphone case, would have considered it obvious to incorporate the improved electrode arrangement of Hwang into the system of Albert.
Regarding claim 2, see Fig. 1 of Hwang, electrodes 111 and 112.
Regarding claim 3, note Figs. 4A and 4B of Albert, where a sub measurement unit 408 is capable of being coupled or separated from the main unit. Such a feature advantageously allows a greater range of placement for the measurement electrodes, and more convenient access to desired measurement regions of the body.
Regarding claim 4, when the third electrode is separated from the main measuring unit as shown in Figs. 4A and 4B of Albert, application of the teachings of Acquista would require the processor to determine if the third electrode is in the non-measurable state so as to reduce overall ECG noise and facilitate ECG interpretation.
Regarding claim 6, while Albert does not concern himself with a discussion of electrode type, since ECG electrodes fall into either one of the categories --wet or dry-- Albert would inherently require either a dry type or a wet type electrode. In any event, Hwang discloses as a matter of convenience, that dry electrodes can be used (see par. 0007). Clearly since both electrode types are old and well-known in the ECG monitoring arts and both are suitable for the intended purpose of collecting cardiac signals from the body, the use of either type would have been considered blatantly obvious and a matter of design with the selection based on individual preferences, availability, cost, convenience, etc..
Regarding claim 8, note par. 0052 which teaches that a wireless connection may be employed in an alternative embodiment to the wired connection.
Regarding claim 11, note pars. 0065 and 0066 of Albert.
Regarding claim 12, see par. 0059.
Regarding claim 13, the mobile computing device is considered to be an output unit as it allows one to view ECG information (par. 0053) and user notification information (pars. 0065, 0080, 0106).
Response to Arguments
Applicant's arguments filed June 23, 2025 have been fully considered but they are not persuasive.
Lacking an effective terminal disclaimer or sufficient amendment to distinguish over the patented invention, the obviousness-type double patenting rejection is repeated.
Regarding the rejection under §101, the applicant argues that the claims now recite concrete, non-conventional hardware and firmware features that materially improve ECG measurement accuracy, device portability, and user comfort. It is stated that the determination of a quality of an electrical signal received from each electrode and the determination of whether each electrode is in a measurable state based on the quality of the respective electrical signals, requires an evaluation of signal strength, waveform shape, or timing against predetermined thresholds, which is alleged to be unknown criteria in conventional ECG devices, and excludes noisy or spurious signals from the measurement process. As a consequence, it is stated that such a process directly enhances the fidelity of the recorded ECG trace.
This is not found to be convincing because the applicant is relying upon the abstract idea itself for the alleged improvement. As stated in MPEP 2106.05, I., the inventive concept must be furnished by an element or combination of elements in addition to (beyond) the judicial exception. The evaluation of electrode signal quality can be performed within the mind, and is thus a part of the abstract idea. A cardiologist, for example, could review the signals and evaluate the signal strength, waveform shape, or timing against predetermined thresholds, and make a judgement as to the quality of the signal. The fact that a generic processor is used to make this determination in the present invention is insufficient because the processor merely acts as a tool upon which the abstract idea is performed.
The applicant additionally argues that the processors calculate a changed type of ECG lead based on the number of electrodes in a measurable state or changed attachment position, and that such a feature enables automatic on-the-fly reconfiguration of the leads, thus improving ambulatory monitoring.
Here again the applicant is relying upon the abstract idea itself to provide the improvement. The calculation of changed types of ECG leads based on the number of electrodes in a measurable state or changed attachment position, is a feature that can be performed within the mind as discussed above. The recited use of a WURC processor to perform this calculation is also insignificant as it merely provides the means with which to execute the abstract idea.
Regarding the rejection based on prior art, the applicant argues that Acquista fails to disclose the feature of “receiving electrical signals from a first electrode, the second electrode, and the third electrode, determining the quality of the electrical signal received from each of the three electrodes, and determining whether each electrode is in a measurable state based on the quality of the respective electrical signal.
The examiner respectfully disagrees. Acquista discloses receiving electrical signals from a set of electrodes and determining the quality of the electrical signal received from each of the three electrodes (S/N ratio of each functional electrode is checked; par. 0069; where application to the system of Albert would include at least first, second and third electrodes as discussed in the above §103 rejection), and determining whether each electrode is in a measurable state based on the quality of the respective electrical signal (Fig. 7; element 740, where the electrode is in a measurable state based on whether it is functional and based on an acceptable S/N ratio (i.e., electrical signal quality).
The applicant then argues that Acquista fails to disclose the feature of calculating a changed type of ECG lead based on a changed number of electrodes in a measurable state or a changed attachment position of the electrodes, when the number of electrodes in a measurable state or the attached position of the electrodes is changed during the ECG measurement.
The examiner again respectfully disagrees. The examiner is relying on the teachings of Albert to provide this feature as discussed in the rejection above. Acquista is used for the suggestion of monitoring the quality of the electrode signals.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Simon ‘639 discloses an ECG measuring device with automatic lead selection based on the measurable state of electrodes. Bruinsma ‘159 disclose a portable ECG device where electrodes with noise are identified and an ECG signal is generated based on the signals from low-noise electrodes. Bruinsma also discloses that measurement electrodes may be located on any surface of the device, and in some cases may be located on an accessory that can be detachable from the main device. The use of wet and dry electrodes is also disclosed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
August 28, 2025