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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 23, 2025 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “resampled the first 3-lead ECG dataset” on line 12 is grammatically awkward. Deletion of the word “the” is suggested. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 and 20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Parent claims 1 and 15 already require that the first 3-lead ECG dataset be synchronized with the first 12-lead ECG dataset by resampling at least one of the first 12-lead ECG dataset and the first 3-lead ECG dataset (at least one of these datasets inherently must be resampled since they are the only datasets received by the device). It is therefore unclear what further limitation is being expressed in claims 6 and 20. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-12 and 15-26 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 actions of determining a time shift between at least one lead of the first 12-lead ECG dataset and at least one lead of the first 3-lead ECG dataset; resampling, based on the determined time shift, the first 3-lead ECG dataset to be closer in length to the first 12-lead ECG dataset; synchronizing the first 3-lead ECG dataset to the first 12-lead dataset based on the resampled first 3-lead ECG dataset; determining, during a calibration phase, a set of linear transformation parameters to synthesize a second 12-lead ECG dataset based at least in part on the synchronized first 12-lead ECG dataset and a first 3-lead ECG data, and synthesizing, in an ongoing monitoring phase, the second 12-lead ECG dataset from a second 3-lead ECG dataset associated with a third collection time based at least in part on the set of linear transformation parameters. The determination of linear transformation parameters and synthesis of ECG datasets involves mathematical manipulations that can be done within the mind or with the aid of pen and paper. The algorithm associated with the determination of a time shift, resampling and synchronizing involves comparisons of ECG signals/datasets and selection of new data points, and can be done visually from the collected data, or with pen and paper, by observation of the received ECG data and using judgement/opinion to align or mathematically cross-correlate the data.
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 portable ECG device with a plurality of electrodes configured to contact a patient’s chest and hands, the non-transitory computer-readable storage medium, and the one or more processors function in their usual capacity of collecting data, storing data, processing data, and displaying data; there is no application or use of a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition (only signal processing and non-specific treatment) – see Vanda Memo; there is no application of the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b), as the portable ECG, storage media, and one or more processors are generic as is the combination of elements; there is no transformation or reduction of a particular article to a different state or thing because the invention merely involves data manipulation and/or unspecified treatment, as discussed in MPEP 2106.05(c); 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 ECG 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 in claims 1 and 15, the receiving operations are considered at best insignificant extra-solution activity amounting to necessary data collection. The receipt of 12-lead and 3-lead ECG datasets would be required in any implementation of the abstract idea. Similarly, the outputting of the 12-lead ECG dataset is considered necessary data outputting that would be required in any system intent on synthesizing a 12-lead ECG dataset. The act of treating in claim 1 fails to provide practical application because the treatment is non-specific. MPEP 2106.04(d)(2) requires an action that effects a particular treatment or prophylaxis for a disease or medical condition, in order to establish a practical application:
The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). For example, consider a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications. This falls within the mental process grouping of abstract ideas enumerated in MPEP §2106.04(a). The claim also recites "administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype." This administration step is particular, and it integrates the mental analysis step into a practical application. Conversely, consider a claim that recites the same abstract idea and "administering a suitable medication to a patient." This administration step is not particular, and is instead merely instructions to "apply" the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application.
In the present case, the term “treatment” is broad enough to refer to any form, including ablation, cardiac stimulation, neural stimulation, drug treatment, exercise, mediation, etc.. Furthermore, the treatment limitation must have more than a nominal or insignificant relationship to the exception (MPEP 2106.04(d)(2) subsection b):
The treatment or prophylaxis limitation must have more than a nominal or insignificant relationship to the exception(s). For example, consider a claim that recites a natural correlation (law of nature) between blood glucose levels over 250 mg/dl and the risk of developing ketoacidosis (a life-threatening medical condition). The claim also recites "treating a patient having a blood glucose level over 250 mg/dl with insulin". Insulin acts to lower blood glucose levels, and administering insulin to a patient will reduce the patient’s blood glucose level, thereby lowering the risk that the patient will develop ketoacidosis. Thus, in the context of this claim, the administration step is significantly related to the recited correlation between high blood glucose levels and the risk of ketoacidosis. Because insulin is also a "particular" treatment, this administration step integrates the law of nature into a practical application. Alternatively, consider a claim that recites the same law of nature and also recites "treating a patient having a blood glucose level over 250 mg/dl with aspirin." Aspirin is not known in the art as a treatment for ketoacidosis or diabetes, although some patients with diabetes may be on aspirin therapy for other medical reasons (e.g., to control pain or inflammation, or to prevent blood clots). In the context of this claim and the recited correlation between high blood glucose levels and the risk of ketoacidosis, administration of aspirin has at best a nominal connection to the law of nature, because aspirin does not treat or prevent ketoacidosis. This step therefore does not apply or use the exception in any meaningful way. Thus, this step of administering aspirin does not integrate the law of nature into a practical application.
Here the treatment of the patient based on the second synthesized 12-lead dataset is insignificant, and at best, only has a nominal relationship to the 12-lead dataset. The treatment is simply dependent on whatever condition is indicated by the output data set. A host of different conditions could be indicated by the dataset, with a corresponding host of suitable treatments. The claim is effectively stating: whatever the treatable condition is, treat it (i.e., mere instructions to apply an exception). As stated in MPEP 2106.05(f), subsection 3:
The particularity or generality of the application of the judicial exception. A claim having broad applicability across many fields of endeavor may not provide meaningful limitations that integrate a judicial exception into a practical application or amount to significantly more.
Regarding apparatus claim 15, the additional elements of the portable ECG device, non-transitory medium, one or more processors, are merely the tools upon which the abstract idea is performed. The individual elements, as well as their combination, function in the usual manner and are generic in form. The outputting operation is further considered insignificant data output as all applications of the abstract idea of synthesizing a 12-lead ECG would require such output. It is noted that claim 15 does not include the requirement for therapy.
The receipt of ECG datasets, portable ECG devices, non-transitory computer-readable storage media, one or more processors and data outputting are further WURC in the ECG signal processing art. As stated in pars. 0051, 0059, 0061, 0062, 0094, 0095 and 0097 of the present specification, the one or more processors and the display device may be a laptop computer, smart display or monitor, a mobile phone, a cloud-based processing node, or any other feasible system or device. The memory may include well-known mediums such as EPROM, EEPROM, flash memory, hard drives, etc.. The data may be collected and/or recorded with any feasible ECG equipment. The combination of an insignificant generic portable ECG device with electrodes configured to contact a patient’s chest and hands, memory, one or more processors and a means to display/output data is also WURC in the art, as such a combination functions in its usual capacity and would be required in any standard ECG system.
Claims 2-4 and 16-18 represent insignificant data collection activity.
Claims 5-12, 10 and 19-26 represent a mentally performable step and thus contains no additional elements. Regarding claims 6, 7, 20 and 21, as stated above in the rejection of claims 1 and 15, resampling of the datasets is considered a mentally performable task. The resampling is not tied to any specific structure and appears to be the result of data manipulation that involves observation, analysis and judgement and thus, when one is presented the datasets, the resampling task is considered performable within the mind or with aid of pen and paper.
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 1-12 and 15-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,445,963.
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 indicated below, merely 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)).
The determination of a time shift between at least one lead of the first 12-lead ECG dataset and at least one lead of the first 3-lead dataset is reflected in the patented claim by the requirement in the patented invention for a prior received 12-lead ECG collected at a first collection time and a prior received 3-lead ECG collected at a second collection time, to be different than the first collection time (i.e., a determined time shift requiring synchronization by resampling). See also claim 4 of the ‘963 patent.
The inclusion of calibration and monitoring phases is insufficient to distinguish over the claims of the ‘963 patent as the terms “calibration” and “monitoring” are merely arbitrary descriptive adjectives assigned to describe the various existing steps rather than relating to any new steps in the method. By analogy, a claim directed to a process of manufacturing a bicycle including the step of welding the frame during an assembly phase, would not be distinguishable over a process of manufacturing a bicycle that simply includes the step of welding the frame.
The addition of the treatment step (claim 1) to the ‘963 invention would have been considered blatantly obvious to artisans of ordinary skill in the medical art because once a disease or other treatable condition is discovered, it would be unethical and run contrary to the Hippocratic Oath not to attempt treatment.
Regarding claims 2, 3, 16 and 17, while the exact time range of dataset collection time separation is not claimed in the ‘963 patent, the patent does recite that the collection times may be different (claim 1). As the patented invention synchronizes the data to account for different collection times, those of ordinary skill in the art would have considered the exact range of differences between collection times to be a matter of obvious design dependent on routine experimentation, convenience and the availability of tests at any given time. The applicant further expresses no criticality in the relative collection times.
Response to Arguments
Applicant's arguments filed December 23, 2025 have been fully considered but they are not persuasive.
Lacking an acceptable terminal disclaimer or sufficient amendment to distinguish over the claims of the ‘963 patent, the obviousness-type double patenting rejection has been repeated. Please also note the comments above under par. 7 regarding the newly added subject matter.
Regarding the rejection under §101, the applicant asserts that the claims recite specific technological improvements in cardiac monitoring systems and not mental processes. The applicant argues that the present claims are similar to those found eligible in the CardioNet, LLC v. InfoBionic, Inc., decision.
While the present claims and those of Cardionet may be similar in that they both relate to cardiac monitoring, in Cardionet the patent involved monitoring of atrial fibrillation and flutter. It was recognized that the occurrence of ventricular beats is generally unrelated to atrial fibrillation and atrial flutter, whereas it is known to be indicative of ventricular tachycardia. The written description disclosed various technological improvements in the detection of atrial fibrillation and atrial flutter as a result of identifying variability in the beat-to-beat timing of identified ventricular beats, including increased accuracy of atrial fibrillation/flutter detection and the reduction of false positives. Thus, the presence of the additional element of a ventricular beat detector (an element that traditionally is negatively indicative of atrial fibrillation) in combination with the act of identifying a relevance of the variability in the beat-to-beat timing of detected ventricular beats to atrial fibrillation and/or atrial flutter, effectively integrated the abstract idea into a practical application. It was not merely collecting electronic information from a standard arrangement, applying the abstract idea using the information, and displaying the result, where the improvement lies entirely within the performance of the abstract idea, as in the present case.
It is further noted that the court effectively relied upon what is now Prong Two of Step 2A of the revised guidelines by determining that the claims integrated the additional elements into an improvement. Application of this prong is only done after the analysis under Prong One is concluded (i.e., only after the finding that the claim does indeed recite an abstract idea –which in this case involved mentally performable actions). Like in the CardioNet decision, the current claims include mentally performable actions as outlined above and thus recite a judicial exception.
The applicant argues that the determination of a time shift, resampling and synchronizing, focuses on a specific means or method that improves cardiac monitoring technology. It is stated that the invention represents an improvement in that it recites specialized electrodes and an algorithm for resampling and aligning the ECG data when data is collected at disparate times from the reference 12-lead ECG data. An inventive concept cannot, however, be furnished by the unpatentable abstract idea itself, but rather by an element or combination of elements outside of the abstract idea (MPEP 2106.05, I.). Here, determining a time shift and synchronizing by resampling (i.e., the algorithm), are considered a part of the mentally performable abstract idea itself, and do not represent additional elements (e.g., the additional elements of the receiving, outputting and treating steps (claim 1), along with the ECG device comprising one or more processors, a plurality of electrodes, and a non-transitory computer-readable storage medium (claim 15)). The referenced “special electrodes” represent generic data collection structure that would be necessary in any system attempting to synthesize a 12-lead ECG from a 3-lead ECG dataset. If the electrodes are “specialized,” then an adequate disclosure must include an explanation as to how the electrodes are specialized over standard ECG electrodes such as those found in the conventional portable ECG devices of the prior art. The applicant to the contrary, states that any feasible 3 or 12 lead ECG equipment may be used (see for example pars. 0061 and 0062).
Under Step 2B, the applicant similarly argues that the steps of the algorithm in combination with the alleged specialized electrodes are not routine and conventional. Again, the applicant is relying upon the abstract idea itself for the inventive concept and not the additional elements. The function of the electrodes is to merely collect/receive the data necessarily required to execute the algorithm. ECG electrodes of this nature and configuration are WURC in the cardiac monitoring arts. As argued above, pars. 0051, 0059, 0061, 0062, 0094, 0095 and 0097 of the present specification indicate that the one or more processors and the display device may be a laptop computer, smart display or monitor, a mobile phone, a cloud-based processing node, or any other feasible system or device. The memory may include well-known mediums such as EPROM, EEPROM, flash memory, hard drives, etc.. The data may be collected and/or recorded with any feasible ECG equipment. The combination of an insignificant generic portable ECG device with electrodes, memory, one or more processors and a means to display/output data is also WURC in the art, as such a combination functions in its usual capacity and would be required in any standard ECG system.
Lacking any practical application or unconventional arrangements of additional elements, the rejection under §101 must stand.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 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 on the 2nd Monday of the biweek and W-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. Hamaoui can be reached on 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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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
April 18, 2026
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