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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 16OCT2025 has been entered.
Status of Claims
The amendments and remarks filed on 16OCT2025 have been entered and considered.
Claims 1-2, 4, 7-13, 15-18, 20, & 24-28 are currently pending.
No claims have been amended.
Claims 3, 5-6, 14, 19, & 21-23 were previously canceled.
Claims 1-2, 4, 7-13, 15-18, 20, & 24-28 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 22JUL2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant's arguments filed 16OCT2025 regarding the rejections under 35 U.S.C 101 have been fully considered but are not persuasive. Parts deemed not persuasive discussed below:
Applicant argues (Pages 8-9 of the Remarks):
“The Office Action states that “the claimed invention is directed to an abstract idea without significantly more.” The motion data and the ECG data described in claim 1 represents thousands of data points to be analyzed. For instance, one skilled in the art would know that ECG data is often sampled at a rate of 100 Hertz (Hz) to 1000 Hz. The sheer amount of data to analyze would be impossible for the human mind in a clinically- relevant timeframe for the treatment of a cardiac condition. According to the Instant Application: During cardiac arrest, the brain and other vital organs are unable to receive sufficient oxygenated blood, which can result in a sudden loss of consciousness. If untreated shortly after onset, cardiac arrest can result in long-term deficits or death. Thus, effective treatments must be applicable in a variety of environments where cardiac arrest is likely to occur, such as environments outside of hospitals or other specialized facilities for administering medical care. q[0002] (emphasis added).”
The examiner is not persuaded. The claim does not require thousands of data points or any particular sampling rate, therefore the argument does not commensurate in scope with the claim. Additionally, the claim does not require the actual delivery of a treatment and only results in a recommendation; therefore, the arguments again are not commensurate in scope with the claim.
Applicant argues (Page 9 of the Remarks):
“Furthermore, “Because a defibrillation shock can be dangerous if administered to individuals without VF or pulseless V-tach, a medical device will generally identify and/or assist in the diagnosis of VF and pulseless V-tach based on electrocardiograms (ECGs).” /d. at [0004]. One of ordinary skill in the art would recognize that ECG analysis cannot be practically performed by the human mind. Accordingly, the analysis of claim 1 could not be practically performed by the human mind, or by a human with a physical aid (e.g., a computer or a pen and paper).”
The claims are currently structured as simply using a generic computer to implement the abstract idea (mental process). The use of the defibrillator can be interpreted as ECG analysis can be done in the human, which is implemented into a generic computer. Applicant has not claimed any particular type of analysis and a trained cardiologist can indeed look at an ECG printout or display and make cardiac analyses on the data. A cardiologist could look at ECG data and determine if a rhythm needs to be shocked. If Applicant has any particular ways in which the data is processed, Applicant should incorporate that into the claim to give the argument weight. Therefore, the examiner is not persuaded.
Applicant argues (Pages 10-11 of the Remarks):
“The specification of the Instant Application describes how irregular movement artifact filtering is superior to previous, chest compression artifact filtering.
The Instant Application describes devices that use “the detection of irregular movement of the patient’ to “prevent[] the user from being misled by incorrect recommendations.”
Thus, the specification describes that a device can identify a shockable rhythm in “an ECG signal with chest compression artifact’ by determining “whether an irregular motion of the individual is greater than a particular threshold.” /d.
Claim 1 is directed to a “defibrillation system” that is capable of “determining that a shockable rhythm is present in [an] ECG” based on “determining that [an] irregular motion of an individual is lower than [a] threshold.””
The examiner is not persuaded since the claim does not provide a clear indication of how the claims are integrated into a practical application. The claim recites “identifying data indicating the motion of the individual receiving the chest compressions”, which is data processing where an individual can identify the motion data that represent CPR induced motion. The limitation “distinguishing a portion of the data indicating irregular motion of the individual from a portion of the data indicating regular motion of the individual, the irregular motion being independent of the chest compressions, the regular motion being caused by the chest compressions” is additionally an action that an individual can do by hand since these motions will be represented differently on the data. Finally, stated limitation “ in response to determining that the irregular motion of the individual is lower than the threshold, generating a filtered ECG by removing, from the ECG, an artifact corresponding to the chest compressions; determining that a shockable rhythm is present in the filtered ECG)...” is not a practical application because the concept of filtering out noise from data is not a new idea. The claims do not show how the invention is more than the automation of someone checking for a good signal to shock at using the defibrillator, with the use of vaguely recited thresholds for the data. This does not show a practical application as currently recited.
Applicant argues (Pages 11-12 of the Remarks):
“ According to the Office Action, “the addition of motion sensors as a sole concept is not in itself a novel configuration or use.” The Office cites US App. Pub. No. 2008/0103402 (“Stickney”) as providing “another example of the motion sensors, in defibrillation technology.” Office Action, p.7. However, the Office has not demonstrated that Stickney discloses the use of motion detectors in defibrillation systems. The Office has not shown that Stickney discloses the use of motion detectors in a defibrillation system. In addition, the Office has not shown that Stickney discloses identifying irregular motion during cardiac monitoring. Accordingly, the Office has not provided a factual determination that the additional elements of using motion detectors is well-understood, routine, and conventional in the field of the Instant Application. See MPEP § 2106.05(d)(I).”
The examiner disagrees as the use of the motion detector or the motion sensor does not significantly change the functions and meanings of the claims and therefore is not a relevant argument. The motion detected in Stickney additionally is focused on CPR motion, which when the claims are under their broadest reasonable interpretation can be considered the motion since it stems from an external source. Stickney shows that detecting motion is known in the art, and using a specific broad means/sensor to determine that motion is not significantly more than the abstract idea. Therefore, Stickney is maintained to show an example of using motion is Defibrillation situations.
Applicant argues (Page 12 of the Remarks):
“As described above, Applicant’s claims do recite additional elements, such as the “motion detector” and “distinguishing a portion of the data indicating irregular motion” of claim 1, that provide various technical improvements to the functioning of defibrillation systems and to the field of cardiac monitoring. The combination of all of the individual additional elements of claim 1 is both non-conventional and improves technology as described above.”
The examiner disagrees because the actions claimed can be performed by a person without the automation of the process using a defibrillator. The steps do not recite functional limitations which show how the invention achieves the processing results, nor does it show elements which are novel. The argued motion detector is not claimed in more than a general manner used for the pre-solution activity of data gathering, and is therefore generic. Therefore, no technical improvement has been shown other than general claims of such in the specification.
Claim Rejections - 35 USC § 101 – Subject Matter Eligibility
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 1-2, 4, 7-13, 15-18, 20, & 24-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: (Is the claim to a statutory category of invention?)
The claims recite:
Claim 13 is to a method (Process).
Claims 1 & 4 are to a system (Machine).
Therefore, claims 1-2, 4, 7-13, 15-18, 20, & 24-28 are directed to a statutory category of invention.
Step 2A, Prong One:
Regarding claims 1, 4, & 13 the limitations of “determining, by analyzing the portion of the data indicating the irregular motion of the individual, that the irregular motion of the individual is lower than a threshold”, “identifying data indicating the motion of the individual receiving the chest compressions”, “distinguishing a portion of the data indicating irregular motion of the individual from a portion of the data indicating regular motion of the individual, the irregular motion being independent of the chest compressions, the regular motion being caused by the chest compressions”, “in response to determining that the irregular motion of the individual is lower than the threshold, generating a filtered ECG by removing, from the ECG, an artifact corresponding to the chest compressions”, “identifying irregular motion and determining that the irregular motion of the individual is lower than a threshold”, and “determining that a shockable rhythm is present in the filtered ECG” are mental processes,. The limitations as drafted, covers performance of the limitations that can be performed by a human using a pen and paper under the broadest reasonable interpretation standard. For example, determining motion artifacts due to patient transport and evaluating treatment guidelines based on the data set encompasses nothing more than a user viewing the data and determining where signals exceed a threshold to determine when there is external motion caused by transportation which will affect shock determinations. If claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in human mind or by a human using a pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. See MPEP 2106.04(a)(2)(III).
Step 2A, Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite additional elements of “motion detector”; “detecting an electrocardiogram (ECG) of the individual based on a relative voltage between the detection electrodes”, “in response to“detection electrodes”; “detection circuit”; “output device”; “processor”; and “memory” these parts are recited at high levels of generality (i.e. The parts themselves do not provide any novel structures). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using motion detectors to account for electrical activity caused by CPR or movement amounts to no more than mere pre-solution activity of data gathering with a specified data target, which does not amount of an inventive concept. This pre-solution activity of data processing and display is well-understood, routine, and conventional in the field of sleep technology and all uses of the recited judicial exception require the pre-solution activity of data gathering. Therefore, the claim is not patent eligible.
Regarding the dependent claims 2 & 25-27the claims do no more to further limit the physical means for acquiring data outside of the “motion detector that comprises a gyroscope, an accelerometer, a camera, a speedometer, a location device, or a location sensor”, “compression detector configured to identify the chest compressions received by the individual”, but these items are generic to the field and do not provide novelty or distinct structure to the claimed invention.
Regarding the dependent claims 7-12 the claims do no more to further limit the physical means for acquiring data outside of the motion detector that comprises a gyroscope, an accelerometer, a camera, a speedometer, a location device, or a location sensor, a discharge circuit, and an input/output device, motion sensor , but these items are generic to the field and do not provide novelty or distinct structure to the claimed invention.
Regarding dependent claims 15-16, 17-18, 20, 24, & 28 the claims do no more to further limit the physical means for acquiring data outside of the motion detector that comprises a gyroscope, an accelerometer, a camera, a speedometer, a location device, or a location sensor, a signal filter, and an input/output device, but these items are generic to the field and do not provide novelty or distinct structure to the claimed invention.
Therefore, claims 1-2, 4, 7-13, 15-18, 20, & 24-28 are directed to an abstract idea without significantly more. Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Silver et al. (US Publication No. 20170106183) (See par. [0133])
Freeman et al. (US Publication No. 20140288450)
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 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 MEGAN FEDORKY whose telephone number is (571)272-2117. The examiner can normally be reached M-F 9:30-4:30. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on M-F 9:30-4:30. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEGAN T FEDORKY/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796