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 .
Response to Arguments
Rejections Under 35 U.S.C 101
Applicant’s arguments filed on 09/11/2025 have been fully considered but are not persuasive.
Step 2A, Prong One:
Applicant argues that the claims require “real-time sensor-based measurement of physical quantities, which the human mind is not able to perform without specialized hardware” and that the process described in the claim is not a mental observation but rather “a technical process for detecting physical abnormalities in electrode-signal acquisition”. Examiner acknowledges that the human mind alone is not capable of performing real-time sensor-based measurement of physical quantities. However, as discussed in MPEP 2106.04(a)(2)(III), the courts consider a mental process thinking that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. The action of “determining whether or not an electrode event…has occurred” is considered a mental process that requires a human to use a physical aid. For this reason, Examiner maintains that the claim is directed to a mental process.
Applicant argues that the 2025 Memo cites examples from the AI-SME Update where claims “involving complex data processing (e.g., hardware-based analysis) do not fall within the mental process grouping”. Examiner acknowledges that the AI-SME does list several examples of claims that are not considered to be reciting a mental process (AI-SME, pg. 58136, col. 1, ¶ 4– col. 2 ¶ 5). However, the specific example applicant is referring to (claim to “a specific-hardware-based RFID serial number data structure” see col. 1, ¶4) is unrelated to Applicant’s claimed subject matter. Applicant is not claiming a “specific hardware-based RFID serial number data structure”, therefore, it would be inappropriate to apply court decisions from ADASA Inc. v. Avery Dennison Corp., 55 F.4th 900, 909 (Fed. Cir. 2022), to Applicants claimed invention.
Step 2A, Prong 2:
Applicant argues that even “assuming a judicial exception is included in the claims” the additional elements of the claim integrate the judicial exception into practical application. Examiner respectfully disagrees. Examiner is not disputing that the invention as a whole may be considered by one of ordinary skill in the art as an improvement to heart-state monitoring technology, however, this improvement is not reflected in the claims. As written, the abstract idea (i.e., determining a patient state) is not integrated into practical application because the claim does not include any application of the determined “patient state”. In other words, the claim does not describe a way in which determining the patient state improves existing technology, it only describes the process in which a patient state is determined. For these reasons, Examiner maintains that the additional elements do not integrate the abstract idea into practical application.
Step 2B:
Applicant argues that the claims amount to “significantly more” than the judicial exception. Examiner respectfully disagrees, the additional elements “acquiring…electrode information” and “acquiring… environmental information” are examples of insignificant extra-solution activity. Additionally, the limitation “wherein the electromagnetic quantity comprises an impedance value measured by applying a current to the electrode” merely provides additional information about how the electromagnetic quantity was obtained. Regardless of whether the claim is well-understood, routine and conventional, the additional elements of the claim are still no more than insignificant extra solution activity and mere data gathering. Specifically, the limitation directed to “using…the environment information to determine whether or not an electrode event…has occurred” is a process capable of being performed in the human mind (including observation, judgment, evaluation, and opinion) under the broadest reasonable standard.
The rejection of claims 1-5 under 35 U.S.C. 101 is maintained.
Rejections Under 35 U.S.C. 102
Applicant’s arguments filed on 09/11/2025 have been fully considered but are moot in view of a new grounds of rejection.
Rejections Under 35 U.S.C. 103
Applicant’s arguments filed on 09/11/2025 have been fully considered but are moot in view of a new grounds of rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In re claim 1, the limitation “wherein the electromagnetic quantity comprises an impedance value measured by applying a current to the electrode”, is considered new matter. Specifically, Examiner can find no mention in Applicants instant specification of the word “impedance”. Paragraph [0029] states that the electromagnetic quantity can be “a voltage” or “a current”, however there is no mention of “an impedance” being the electromagnetic quantity.
Claims 1-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In re claim 1,
The limitation “wherein the electromagnetic quantity comprises an impedance value measured by applying a current to the electrode” is unclear. Specifically, it is unclear how the electromagnetic quantity can “comprise an impedance value” when the electromagnetic quantity was previously defined in the claim to be “an electromagnetic force, field, or energy applied to an electrode…”. Additionally, Examiner can find nothing in the specification about “impedance” or the “electromagnetic quantity comprising an impedance value”. For the purposes of examination, because the limitation (“wherein the electromagnetic quantity comprises an impedance value measured by applying a current to the electrode”) is unclear, inconsistent with previous limitations in the claim, and not described in the specification, no patentable weight will be given to said limitation. In other words, claim 1 will be interpreted as follows:
A state estimation device comprising: an information acquisition unit, implemented using one or more computing devices, configured to acquire at least one of (i) electrode acquisition information indicating an electromagnetic time series of an electromagnetic quantity that is an electromagnetic force, field, or energy applied to an electrode from which a signal indicating a state of a heart of an estimation target is acquirable and (ii) environment information regarding a time series of an environmental quantity that is an amount related to at least one of a state of motion of the estimation target or an environment in which the estimation target is present; and an estimation unit, implemented using one or more computing devices, configured to use at least one of the electrode acquisition information and the environment information to determine whether or not an electrode event, which is an abnormality in acquisition of a signal indicating the state of the heart of the estimation target by the electrode, has occurred.
A broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim recites the broad recitation “configured to acquire at least one of (i) electrode acquisition information…and (ii) environment information…”, and the narrow recitation “configured to use the electrode acquisition information and the environment information”. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. As best understood, based on Applicant’s arguments the limitation “configured to acquire at least one of (i) electrode acquisition information…and (ii) environment information…” will be interpreted as “configured to acquire (i) electrode acquisition information…and (ii) environment information…”.
Examiner notes that dependent claims 2 and 3 inherit the same deficiencies.
In re claim 4, see above (In re claim 1).
In re claim 5, see above (In re claim 1).
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 1-5 are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea (mental process of estimating a state) without significantly more.
STEP 1
In re claim 1, 4 and 5 the claims are directed to statutory subject matter as the claims recite a device, method, and non-transitory recording medium. (STEP 1: YES)
STEP 2A PRONG 1:
In re claim 1, 4 and 5 the limitations of estimating a state, “using…electrode acquisition information…to determine whether or not an electrode event…has occurred” and “using…the environment information to determine whether or not an electrode event…has occurred” are processes capable of being performed in the human mind (including observation, judgment, evaluation, and opinion) under the broadest reasonable standard. These limitations are nothing more and a doctor analyzing electrocardiogram (ECG) and environmental data. For example, a doctor can analyze both ECG and environmental data to determine whether or not an electrode event occurred. Examiner notes that an electrode event could include noticing that the electrodes are detached, improperly attached, or placed incorrectly. (STEP 2A PRONG 1: YES)
STEP 2A PRONG 2
In re claim 1, 4 and 5 the judicial exception is not integrated into practical application. The additional elements “one or more computing devices” and “program” are nothing more than generic computer components. Additionally, the elements “acquiring electrode…information” and “acquiring…environmental information” , “…impedance value measured by applying a current to the electrode” are examples if insignificant pre-extra solution activity. These elements do not impose any meaningful limits on practicing the abstract idea and therefore do not integrate the abstract idea into practical application. See MPEP 2106.05 (f). (STEP 2A PRONG 2: NO)
STEP 2B
In re claim 1, 4 and 5 the claims do not include any additional elements that are sufficient to amount to more than the judicial exception. Specifically, the additional elements “acquiring electrode…information”, “acquiring…environmental information”, and “…impedance value measured by applying a current to the electrode” have been recognized by the courts to be to be insignificant extra-solution activity (See Versata Development Group v. SAP America, 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir.2015), and buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014)). Additionally, viewing the limitations in combination show that they fail to ensure the claims amount to significantly more than the abstract idea. When considered as an ordered combination, the additional elements of the claims add nothing that is not already present when considered separately. (STEP 2B: NO)
Regarding the dependent claims, claims 2-3, are either directed to a) steps that are also abstract b) additional data output or c) further recite additional elements at high level of generality which are conventional in the art.
Claim Rejections - 35 USC § 102
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 1, 4, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sullivan et al. (US 2016/0074667).
In re claim 1, Sullivan discloses a state estimation device (FIG. 2: 200) comprising:
an information acquisition unit (220, 281), implemented using one or more computing devices, configured to acquire at least one of
electrode acquisition information ([0048]: “patient’s sensed ECG”) indicating an electromagnetic time series of an electromagnetic quantity that is an electromagnetic force, field, or energy applied to an electrode from which a signal indicating a state of a heart of an estimation target (282) is acquirable [0048] and
environment information regarding a time series of an environmental quantity [0035] that is an amount related to at least one of
a state of motion of the estimation target [0039] or
an environment in which the estimation target is present [0041]; and
an estimation unit (230 ), implemented using one or more computing devices, configured to use the electrode acquisition information (FIG. 6: 510 “physiological input”; [0048]: “…sensed ECG…can be available as physiological inputs”) and the environment information (520; [0084]: “input from motion detector”) to determine whether or not an electrode event (640, 672; where electrode event is “moving shock criterion met”), which is an abnormality in acquisition of a signal indicating the state of the heart of the estimation target by the electrode, has occurred (640, 672; [0096]) , *wherein the electromagnetic quantity comprises an impedance value measured by applying a current to the electrode.
*Regarding the limitations “wherein the electromagnetic quantity comprises an impedance value measured by applying a current to the electrode.”, see above in Claim Rejections 112 (specifically Claim Rejection 112(b), first bullet of In re claim 1).
In re claim 4, see above (In re claim 1).
Additionally, Sullivan discloses
a state estimation method (FIG. 6; [0093-0096])
In re claim 5, see above (In re claim 1).
Additionally, Sullivan discloses
a non-transitory recording medium storing a program, wherein execution of the program causes a computer to perform operations [0052]
Claim Rejections - 35 USC § 103
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.
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 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al. (US 2016/0074667) in view of Schulhauser et al. (US 2020/0038671).
In re claim 2, Sullivan discloses wherein the estimation unit is configured to determine an occurrence of a cardiac abnormality event that is an abnormality of the state of the heart of the estimation target based on the electrode acquisition information ([0048]: “ventricular fibrillation detector”), and
Sullivan lacks:
wherein the estimation unit is configured to estimate an estimation reliability that is a probability of an estimation result of occurrence of the cardiac abnormality event.
Schulhauser discloses an analogous device that analyzes sensed ECG signals to determine a patient state (abstract). Additionally, Schulahauser discloses providing a probability estimate that indicates the likelihood of whether a cardiac event ([0104]: “not normal state”) has occurred.
Schaulhauser further discloses taking other factors into account (like motion artifacts, loss of signal and possible electrode peeling) when determining if a patient is experiencing an event [0106].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the estimation unit of Wada to determine the estimate the probability of an occurrence of a cardiac event, as taught by Schulhauser. One would have been motivated to make this modification because early identification of cardiac events can help ensure that a patient receives timely treatment.
In re claim 3, the proposed combination yields wherein the estimation reliability is estimated also based on a result of determination of occurrence of the electrode event [0106].
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Choe et al. (US 2016/0378965) discloses a biometric device (abstract) that can detect electrode attachment/detachment.
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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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, David Hamaoui can be reached at (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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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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