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 .
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: “input device” in claims 3, 7 and 12.
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.
Claim Rejections - 35 USC § 112
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 4-12 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.
1) Claim limitation “therapy component” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The term “component” is a generic placeholder which does not recite sufficient structure to perform the entirety of the function of “therapy” and “output therapy”. The specification does not use the terms “component” or “therapy component” in association with a particular structure. Thus, there is no clear link in the disclosure between the 112f-invoking terms claimed (“therapy component”) and the structure they are meant to cover (and equivalents thereof). Thus, it is unclear what the scope of “therapy component” is, making the metes and bounds of the claims indefinite.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 4-10, and 12-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1)
Claim 4 is drawn to a product and Claim 13 recites a method, thus the claims belongs in one of the four statutory categories. All dependent Claims meet this step.
Step 2a, prong one)
Starting with Claim 13, the claim recites “detecting an electrocardiogram[/signal] of a subject; determining that the subject is operating a medical device; in response to [the] determining…: determine that the subject is incapacitated…outputting a therapy” which is directed to an ineligible concept, namely an abstract idea. In terms of abstract ideas, these limitations would also cover: i) any basic first response behavior or interaction, such as a physician finding (or witnessing) an incapacitated (ranging from unconscious to dizzy or having any type of health ailment or episode and so on) patient wearing a health monitor (e.g. a Holter or a smartwatch), the physician reading the monitor or detecting any other form of a signal (e.g. a chart, a printout, a briefing by a nurse) and determining and/or communicating a therapy, which would fall under the abstract idea-methods of organizing human activity [see MPEP 2106.04(a)(2).II.C.iii], and ii) a mental process performed in the human mind or by mere use of pen and paper, such as observing and evaluating the behavior or condition of the subject (e.g. an incapacitated patient with a wearable monitor) and determining an appropriate therapy. All of the limitation mentioned above can be performed by the human mind (or by mere user of pen and paper). The exact same analysis applies to Claim 4. All dependent claims include this ineligible concept.
Step 2a, prong two)
Regarding Claim 13, this judicial exception is not integrated into a practical application because: the claims do not recite an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. In fact, no additional elements are recited in Claim 13. To the extent that the signal is an “electrocardiogram” (where no ECG machine is positively recited) and the “outputting a therapy” being “to the subject” are considered additional elements: The claims merely add the generic “electrocardiogram” and “outputting a therapy to the subject” which attempt to generally link the use of the exception to a technological environment and are drawn to extra solution activity. It does not even require administering actual therapy to the subject, let alone any particular therapy. The generic “outputting a therapy to the subject” is by no means a particular treatment step. The electrocardiogram is a generic and ubiquitous signal that could be in the form of observing the signal on a screen or on paper, and offers no specifics as to what exactly the role of this signal is in the claim, other than to generally link the claim to a technological environment. No structural element is recited in Claim 13 as to the data gathering or output. These are broad enough to the point where it could also be said to be part of the abstract idea itself (e.g. writing down an instruction or notifying the subject after the fact; observing a signal from a screen or a printout or even a verbal communication by a nurse). These limitations are generally linking the use of the exception to a generic technological environment or field of use, to perform the ineligible concept. None of these limitations add to the claims: a) improvements to the functioning of a computer, or to any other technology or technical field, b) use of the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, c) a particular machine or a transformation, or d) use of the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. The same applies to Claim 4, with the addition of “detection circuit”, “therapy component” and “processor”, which, again, merely attempt to link the use of the exception to a technological environment with reference to generic hardware, without integrating the exception to a practical application. Note here that claim 4 does not even require a structure to effect the output.
The same applies to all dependent claims, with the exception of Claims 11 which includes a particular detection of ventricular fibrillation and a particular treatment of electrical shock or pacing to the heart. Of particular note, Claims 5 and 14, do not in fact limit the claim to a particular therapy, at least because “outputting” the therapy includes merely communicating (or even thinking of) a suggestion or plan for therapy. No therapy need be delivered in Claim 14, and no particular structure to deliver it is required by Claim 5. All the other dependent claims merely add generic elements for data gathering and other extra-solution activities that merely link the claims to a technological environment without integrating the exception to a practical application. Thus, only Claim 11 meets the requirements of step 2a, prong two.
Step 2b)
Again, starting with claim 13, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because of all the reasons explained in Step 2a, prong two, and in addition, all of those additional elements individually or in combination are well-understood, routine and conventional activity in the field. No structural element is recited in Claim 13 as to the data gathering or output. To the extent that the detected signal being an “electrocardiogram” (where no ECG machine is positively recited) and the device used being “medical”, were to be considered an additional element: ECG signal detection and associated medical devices are well known, routine and conventional (see Webster, Volpe, and Sullivan, in the subject matter rejections below). These are recited with a high level of generality, that merely append the exception to the bare minimum of any type of monitoring in the art. The same applies to Claim 4, with the addition of “detection circuit”, “therapy component” and “processor” which are well known, routine and conventional elements. Note here that claim 4 does not even require a structure to effect the output. None of these make a contribution that would be significantly more than the exception. There is no reading of Claims 4 and 13 where the sum of the parts are greater than the whole. This conclusion is further supported by the subject matter rejections below. Regarding dependent claims 5-10, 12-20, the foregoing applies to these as well. All of the additional elements recited are well-known, routine and conventional (for data gathering, and routine generic processing of the exception).
Thus, no claim meets the requirements of Step 2b. As noted in step 2a), Claim 11 is eligible.
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 4-6, 8-11 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190143131 by Webster.
Regarding Claim 4, Webster discloses a medical device (e.g. abstract: AED), comprising:
a detection circuit configured to detect an electrocardiogram (ECG) of a subject (e.g. ¶¶ 58: ECG detection; Fig. 21, ¶¶ 207-208: detection module 2132);
a therapy component configured to output a therapy to the subject (e.g. ¶8: defibrillator; Fig. 21: AED 2101 with energy storage 2152 and discharge circuit 2157); and
a processor (e.g. Fig. 21: processor 2130) configured to:
determine that the subject is operating the medical device [a) according to Applicant’s own specification, simply selecting a mode of operation to be an automated mode, called “patient mode” by Applicant, is sufficient to meet determining that the subject is operating the external defibrillator, see ¶79 of the instant application: “Optionally, the entity determines that the subject is operating the entity. For example, the entity detects an input signal indicating that the subject has selected a patient-operated mode of the entity” and ¶16: “When the medical device is operating in a patient-operated mode, it is configured to automatically treat a patient when the patient becomes incapacitated”, aka a standard AED mode; Thus, the capability of mode selection between WCD, full AED and semi-automated AED, as disclosed by Webster in e.g. ¶¶ 33, 63, 136, and Fig. 21, would meet the claimed determination of a subject selecting a mode. For example, selecting WCD as is done by the patient in e.g. ¶116, would meet determining that a subject is operating the device, and is thus on WCD mode; b) Furthermore, it is noted that the claim does not require authentication or identification of a particular person. As a product claim, the “subject” is not required, and may be any user. Thus, this limitation would be met, under the broadest reasonable interpretation, even by the capability of the device to be turned on; c) e.g. Fig. 8: patient input 810 and ¶164: live man switch];
in response to determining that the subject is operating the medical device: determine that the subject is incapacitated (Note here that “incapacitated” would include any lack of capacity or normal functioning, and determining any condition which would affect the heart, such as VF, SCA would meet the claimed determination of lack of capacity; e.g. ¶¶168,178: determination of ventricular fibrillation and sudden cardiac arrest via a combination of sensors, including ECG and motion sensors; Fig. 8: 1st, 2nd shock criteria; Also note here that as seen in Fig. 8, the monitoring is a loop, thus any step in the loop is in response to any of the previous steps, and the device is configured for long term use, see ¶47); and
in response to determining that the subject is incapacitated, causing the therapy component to output the therapy to the subject (e.g. Fig. 8: shocks are delivered in response to the criteria of detection of VF/SCA).
Regarding Claim 5, Webster teaches the medical device of claim 4, wherein the therapy comprises defibrillation (e.g. abstract: AED).
Regarding Claim 6, Webster teaches the medical device of claim 4, further comprising: an electrical contact electrically coupled to the detection circuit, the detection circuit being configured to detect an electrical potential between the electrical contact and an electrode affixed to the subject, and wherein the processor is configured to determine that the subject is incapacitated by: analyzing the electrical potential between the electrical contact and the electrode (note here that the “electrode affixed to the subject” is not positively recited by the claim, and is merely part of the intended use/capability of the detection circuit; e.g. ¶39, Fig. 19: multiple electrodes are used to determine ECG, and ECG, as noted in Claim 4, is part of the measurements used to determine VF/SCA, see ¶168,178).
Regarding Claim 8, Webster teaches the medical device of claim 4, further comprising: a sensor configured to detect a physiological parameter of the subject, wherein the processor is configured to determine that the subject is incapacitated by analyzing the physiological parameter (e.g. ¶168,178: multiple sensors are used to determine VF/SCA).
Regarding Claim 9, Webster teaches the medical device of claim 4, wherein the physiological parameter comprises a plethysmograph of the subject, and wherein the processor is configured to determine that the subject is incapacitated by determining that the plethysmograph indicates that the subject lacks pulsatile blood flow (e.g. ¶166,168,178: optical sensors, oximeters, oxygen saturation measurements, including blood flow, oxygen saturation, discoloration, all indicating blood flow).
Regarding Claim 10, Webster teaches the medical device of claim 8, wherein the physiological parameter comprises an acceleration of a limb of the subject, and wherein the processor is configured to determine that the subject is incapacitated by determining that the acceleration is below a threshold acceleration for greater than a threshold period of time (¶103,127,166,168,178: accelerometer is part of the sensors to determine VF/SCSA).
Regarding Claim 11, Webster teaches the medical device of claim 4, wherein the processor is configured to cause the therapy component to output the therapy to the subject by: determining that the ECG is indicative of an arrhythmia comprising ventricular fibrillation; and in response to determining that the ECG is indicative of the arrhythmia, causing the therapy component to output an electrical shock pulses to a heart of the subject (e.g. ¶168,178: multiple sensors, including ECG are used to determine VF/SCA; Fig. 8: shocks are delivered in response to the criteria of detection of VF/SCA).
Regarding Claim 13, Webster discloses a method, comprising:
detecting an electrocardiogram (ECG) of a subject (e.g. ¶¶ 58: ECG detection; Fig. 21, ¶¶ 207-208: detection module 2132);
determining that the subject is operating a medical device device [a) according to Applicant’s own specification, simply selecting a mode of operation to be an automated mode, called “patient mode” by Applicant, is sufficient to meet determining that the subject is operating the external defibrillator, see ¶79 of the instant application: “Optionally, the entity determines that the subject is operating the entity. For example, the entity detects an input signal indicating that the subject has selected a patient-operated mode of the entity” and ¶16: “When the medical device is operating in a patient-operated mode, it is configured to automatically treat a patient when the patient becomes incapacitated”, aka a standard AED mode; Thus, selecting between WCD, full AED and semi-automated AED, as disclosed by Webster in e.g. ¶¶ 33, 136, and Fig. 21, would meet the claimed step. For example, selecting WCD as is done by the patient in e.g. ¶116, would meet determining that a subject is operating the device, and is thus on WCD mode; b) e.g. Fig. 8: patient input 810 and ¶164: live man switch];
in response to determining that the subject is operating the medical device: determine that the subject is incapacitated (Note here that “incapacitated” would include any lack of capacity or normal functioning, and determining any condition which would affect the heart, such as VF, SCA would meet the claimed determination of lack of capacity; e.g. ¶¶168,178: determination of ventricular fibrillation and sudden cardiac arrest via a combination of sensors, including ECG and motion sensors; Fig. 8: 1st, 2nd shock criteria; Also note here that as seen in Fig. 8, the monitoring is a loop, thus any step in the loop is in response to any of the previous steps, and the device is configured for long term use, see ¶47); and
in response to determining that the subject is incapacitated, outputting a therapy to the subject (e.g. Fig. 8: shocks are delivered in response to the criteria of detection of VF/SCA).
Regarding Claim 14, Webster discloses the method of claim 13, wherein the therapy comprises defibrillation (e.g. abstract: AED).
Regarding Claim 15, Webster discloses the method of claim 13, wherein determining that the subject is operating the medical device comprises analyzing the ECG (e.g. ¶39, Fig. 19: multiple electrodes are used to determine ECG, and ECG, as noted in Claim 4, is part of the measurements used to determine VF/SCA, and thus determine that the patient is using the device, see ¶168,178; Note that “operating the device” is broad enough to include the mere use of the device by contact, ie. any physiological signal of a subject is by default self-evident of the use of the device taking the signal).
Regarding Claim 16, Webster discloses the method of claim 13, further comprising: detecting an electrical potential between an electrical contact and an electrode affixed to the subject, wherein determining that the subject is operating the medical device comprises analyzing an electrical potential between the electrical contact and the electrode (e.g. ¶39, Fig. 19: multiple electrodes are used to determine ECG, and ECG, as noted in Claim 4, is part of the measurements used to determine VF/SCA, and thus determine that the patient is using the device, see ¶168,178; Note that “operating the device” is broad enough to include the mere use of the device by contact, ie. any physiological signal of a subject is by default self-evident of the use of the device taking the signal).
Regarding Claim 18, Webster discloses the method of claim 13, wherein outputting the therapy to the subject is in response to determining that the ECG is indicative of an arrhythmia comprising ventricular fibrillation (¶39, Fig. 19: multiple electrodes are used to determine ECG, and ECG, as noted in Claim 4, is part of the measurements used to determine VF/SCA).
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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190143131 by Webster in view of US 2017/0188979 by Volpe.
Regarding Claim 1, Webster discloses a dual-mode external defibrillator (e.g. abstract: defibrillator with three modes), comprising:
a detection circuit configured to detect an electrocardiogram (ECG) of a subject (e.g. ¶¶ 58: ECG detection; Fig. 21, ¶¶ 207-208: detection module 2132);
a discharge circuit configured to output an electrical shock to the subject (e.g. ¶8: defibrillator; Fig. 21: AED 2101 with energy storage 2152 and discharge circuit 2157); and
a processor configured to:
determine that the subject is operating the dual-mode external defibrillator; in response to determining that the subject is operating the dual-mode external defibrillator [a) according to Applicant’s own specification, simply selecting a mode of operation to be an automated mode, called “patient mode” by Applicant, is sufficient to meet determining that the subject is operating the external defibrillator, see ¶79 of the instant application: “Optionally, the entity determines that the subject is operating the entity. For example, the entity detects an input signal indicating that the subject has selected a patient-operated mode of the entity” and ¶16: “When the medical device is operating in a patient-operated mode, it is configured to automatically treat a patient when the patient becomes incapacitated”, aka a standard AED mode; Thus, the capability of mode selection between WCD, full AED and semi-automated AED, as disclosed by Webster in e.g. ¶¶ 33,63, 136, and Fig. 21, would meet the claimed determination of a subject selecting a mode. For example, selecting WCD as is done by the patient in e.g. ¶116, would meet determining that a subject is operating the device, and is thus on WCD mode; b) Furthermore, it is noted that the claim does not require authentication or identification of a particular person. As a product claim, the “subject” is not required, and may be any user. Thus, this limitation would be met, under the broadest reasonable interpretation, even by the capability of the device to be turned on; c) e.g. Fig. 8: patient input 810 and ¶164: live man switch; Also note here that as seen in Fig. 8, the monitoring is a loop, thus any step in the loop is in response to any of the previous steps, and the device is configured for long term use, see ¶47];
determine that the ECG is indicative of ventricular fibrillation (VF) (e.g. ¶¶168,178: determination of ventricular fibrillation and sudden cardiac arrest via a combination of sensors, including ECG and motion sensors; Fig. 8: 1st, 2nd shock criteria);
in response to determining that the ECG is indicative of VF, determine that the subject is incapacitated (Note here that “incapacitated” would include any lack of capacity or normal functioning, and determining any condition which would affect the heart, such as VF, SCA would meet the claimed determination of lack of capacity; e.g. ¶¶168,178: determination of ventricular fibrillation and sudden cardiac arrest via a combination of sensors, including ECG and motion sensors; Fig. 8: 1st, 2nd shock criteria; Also note here that as seen in Fig. 8, the monitoring is a loop, thus any step in the loop is in response to any of the previous steps, and the device is configured for long term use, see ¶47); and
in response to determining that the subject is incapacitated, cause the discharge circuit to output the electrical shock to the subject (e.g. Fig. 8: shocks are delivered in response to the criteria of detection of VF/SCA)
Webster does not explicitly disclose that the processor determines that the subject is unconscious.
However, Volpe teaches an analogous defibrillator system which determines that the subject is unconscious through a variety of patient response activities (e.g. in response to inadequate patient response input, which is taken as the patient being unconscious, see ¶119,184; Also see ¶96,104,115,117,119,123,133,141,142). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate determination of the subject being unconscious through patient response feedback in a device according to the teachings of Webster, as taught by Volpe, in order to predictably determine that the subject is unconscious, thus making sure that defibrillation is necessary.
Regarding 2, Webster as modified in Claim 1, teaches the dual-mode external defibrillator of claim 1, further comprising: an electrical contact configured to be touched by the subject, wherein the detection circuit is further configured to detect an electrical potential between the electrical contact and electrodes affixed to the subject, the ECG being an electrical potential between the electrodes, and wherein the processor is configured to determine that the subject is operating the dual-mode external defibrillator by analyzing the electrical potential between the electrical contact and the electrodes affixed to the subject (note here that the “electrode affixed to the subject” is not positively recited by the claim, and is merely part of the intended use/capability of the detection circuit; e.g. ¶39, Fig. 19: multiple electrodes are used to determine ECG, and ECG, as noted in Claim 4, is part of the measurements used to determine VF/SCA and by definition detecting a signal from a patient is a determination that the patient is using the device, see ¶168,178).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Webster/Volpe, as applied to Claim 1, and further in view of US 20180184933 by Sullivan.
Regarding 3, Webster as modified in Claim 1, teaches the dual-mode external defibrillator of claim 1, further comprising: an input device configured to receive an input signal from the subject, yet does not disclose wherein the processor is configured to determine that the subject is operating the dual-mode external defibrillator by identifying an artifact in the ECG that corresponds to a time at which the input signal is received from the subject. However, Sullivan teaches an analogous defibrillation system (e.g. abstract), which distinguishes between different types of noise artifacts in the ECG patient input, and suggests that certain types of motion noise artifacts in the ECG signal are an indication that the subject is moving and thus are not unconscious and do not need defibrillation, other types of noise are used to notify the user to take corrective action, lack of which indicating incapacitation (e.g. abstract, ¶¶ 56,68,72,74,75,77). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate detection of motion artifacts in the ECG signal as patient input indications of consciousness or unconsciousness in a device according to the teachings of Webster/Volpe, as taught by Sullivan, in order to predictably detect that the patient is conscious and prevent unnecessary shocks to the patient, and in order to notify the user that certain movements interfere with the measurements and to take corrective action.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Webster, as applied to Claims 4 and 13, in view of US 20180184933 by Sullivan.
Regarding 7, Webster teaches the dual-mode external defibrillator of claim 4, further comprising: an input device configured to receive an input signal from the subject (as discussed in Claim 4), yet does not disclose wherein the processor is configured to determine that the subject is operating the dual-mode external defibrillator by identifying an artifact in the ECG that corresponds to a time at which the input signal is received from the subject. However, Sullivan teaches an analogous defibrillation system (e.g. abstract), which distinguishes between different types of noise artifacts in the ECG patient input, and suggests that certain types of motion noise artifacts in the ECG signal are an indication that the subject is moving and thus are not unconscious and do not need defibrillation, other types of noise are used to notify the user to take corrective action, lack of which indicating incapacitation (e.g. abstract, ¶¶ 56,68,72,74,75,77). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate detection of motion artifacts in the ECG signal as patient input indications of consciousness or unconsciousness in a device according to the teachings of Webster/Volpe, as taught by Sullivan, in order to predictably detect that the patient is conscious and prevent unnecessary shocks to the patient, and in order to notify the user that certain movements interfere with the measurements and to take corrective action.
Regarding Claim 17, Webster discloses the method of claim 13, further comprising: receiving an input signal from the subject; determining a time at which the input signal is received from the subject (as discussed in Claim 13), yet does not disclose wherein determining that the subject is operating the medical device comprises identifying an artifact in the ECG corresponding to the time. However, Sullivan teaches an analogous defibrillation system (e.g. abstract), which distinguishes between different types of noise artifacts in the ECG patient input, and suggests that certain types of motion noise artifacts in the ECG signal are an indication that the subject is moving and thus are not unconscious and do not need defibrillation, other types of noise are used to notify the user to take corrective action, lack of which indicating incapacitation (e.g. abstract, ¶¶ 56,68,72,74,75,77). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate detection of motion artifacts in the ECG signal as patient input indications of consciousness or unconsciousness in a method according to the teachings of Webster/Volpe, as taught by Sullivan, in order to predictably detect that the patient is conscious and prevent unnecessary shocks to the patient, and in order to notify the user that certain movements interfere with the measurements and to take corrective action.
Claims 12 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190143131 by Webster, as applied to Claims 4,13, and 18, respectively, in view of US 2017/0188979 by Volpe.
Regarding Claim 12, Webster as modified in Claim 1 teaches the medical device of claim 4, further comprising: an input device configured to detect an input signal from the subject (as discussed in Claim 4, multiple sensors are used to acquire patient input), yet does not explicitly disclose wherein the processor is configured to determine that the subject is incapacitated by: determining that the input signal has ceased. However, Volpe teaches an analogous defibrillator system which determines that the subject is unconscious through a variety of patient response activities and lack thereof (e.g. in response to inadequate or absent patient response input, which is taken as the patient being unconscious, see ¶119,184; Also see ¶96,104,115,117,119,123,133,141,142). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate determination of the subject being unconscious through patient response feedback (lack thereof taken as an indication of the patient being unconscious) in a device according to the teachings of Webster, as taught by Volpe, in order to predictably determine that the subject is unconscious, thus making sure that defibrillation is necessary.
Regarding Claim 19, Webster discloses the method of claim 18, yet does not explicitly disclose wherein the therapy is output at a predetermined time period after the ECG is indicative of the arrhythmia. However, Volpe teaches an analogous defibrillator system which determines that the subject is unconscious through a variety of patient response activities and lack thereof after the detection of VF, some of which activities requiring a response within a predetermined period of time, thus delaying the treatment to the expiration of said time (e.g. in response to inadequate or absent patient response input, which is taken as the patient being unconscious, see ¶119,184; Also see ¶96,104,115,117,119,123,133,141,142; ¶¶ 13, 36,56,57,63,66,68). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate determination of the subject being unconscious through patient response feedback in a predetermined period of time in a device according to the teachings of Webster, as taught by Volpe, in order to predictably determine that the subject is unconscious, thus making sure that defibrillation is necessary.
Regarding Claim 20, Webster discloses the method of claim 13, further comprising: detecting an input signal from the subject, yet does not disclose wherein determining that the subject is incapacitated comprises determining that the input signal has ceased. However, Volpe teaches an analogous defibrillator system which determines that the subject is unconscious through a variety of patient response activities and lack thereof (e.g. in response to inadequate or absent patient response input, which is taken as the patient being unconscious, see ¶119,184; Also see ¶96,104,115,117,119,123,133,141,142). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate determination of the subject being unconscious through patient response feedback (lack thereof taken as an indication of the patient being unconscious) in a method according to the teachings of Webster, as taught by Volpe, in order to predictably determine that the subject is unconscious, thus making sure that defibrillation is necessary.
Claims 1, 4 and 13 are also rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0188979 by Volpe in view of US 20190143131 by Webster.
Regarding Claims 1, 4 and 13, Volpe teaches an external defibrillator and a method of using it (e.g. ¶¶10,20: defibrillator for external use), comprising:
a detection circuit configured to detect an electrocardiogram (ECG) of a subject (e.g. ¶¶ 99,101,104, 106: the controller 120 includes ECG monitoring and the device includes ECG electrodes 112; Fig. 3: sensor interface 312 and cardiac event detector 326);
a discharge circuit configured to output an electrical shock to the subject (e.g. ¶¶ 69, 101, 103, 105: therapeutic defibrillation shocks are delivered by the controller 120 via electrodes 114; Fig. 3: therapy delivery interface); and
a processor (e.g. Fig. 3: processor 318) configured to:
determine that the subject is operating the external defibrillator [e.g. a) First, it is noted that the claim does not require authentication or identification of a particular person. As a product claim, the “subject” is not required, and may be any user. Thus, this limitation would be met, under the broadest reasonable interpretation, even by the capability of the device to be turned on. Also note here, that according to Applicant’s own specification, simply selecting a mode of operation to be an automated mode, called “patient mode” by Applicant, is sufficient to meet determining that the subject is operating the external defibrillator, see ¶79 of the instant application: “Optionally, the entity determines that the subject is operating the entity. For example, the entity detects an input signal indicating that the subject has selected a patient-operated mode of the entity” and ¶16: “When the medical device is operating in a patient-operated mode, it is configured to automatically treat a patient when the patient becomes incapacitated”, aka a standard AED mode; Clearly, Volpe teaches a user activating the device, as the device is portable and operates with a battery, see ¶104. The very operation of the device by the processor is a determination that the device is on, and thus meets this limitation under the broadest reasonable interpretation. b) In addition, Volpe discloses that the controller identifies the patient in multiple interactive ways and this interaction is an operation of the device. ¶96: identification of patient and confirmation of identification. ¶104: the patient can interact with the screen “to control the medical device 100” and the device requests the patient to respond. ¶107: patient control of the device. ¶113: response buttons 210 are used as one means for the patient to respond for patient identification. ¶113: patient confirms identity with password or passcode. Table 1 in ¶145 shows other methods of patient identification and response. Also see ¶¶ 12-13,15,22-23,25-26,29-37,39-47,188,191);
in response to determining that the subject is operating the external defibrillator (Note that “in response” does not require an immediate or direct response. Clearly, all functionality of the device is in response to activating the device, and furthermore the monitoring and operation of the device is continuous, see ¶¶ 101,111, thus any step in the normal operation of the device is in response to all the previous steps in the algorithm. In other words, the device doesn’t stop monitoring when the patient responds correctly, and every step after a first event and response, is in response to the first recognition of a correct input response by the patient. The device of Volpe is capable of this functionality):
determine that the ECG is indicative of ventricular fibrillation (VF) [e.g. ¶95: detection of ventricular fibrillation (VF) as a patient event];
in response to determining that the ECG is indicative of VF, determine that the subject is unconscious (e.g. in response to inadequate patient response input, which is taken as the patient being unconscious, see ¶119,184; Also see ¶96,104,115,117,119,123,133,141,142); and
in response to determining that the subject is unconscious, cause the discharge circuit to output the electrical shock to the subject (e.g. ¶¶70,104,192: if the device detects that the user is unconscious, it administers defibrillation shocks)
Volpe does not explicitly disclose that the external defibrillator is dual mode.
However, Webster teaches an analogous defibrillation system which operates in multiple modes, including a fully automatic AED mode and a semi-automated AED mode (e.g. abstract, ¶¶5,8; Fig. 13: selection of mode via the user interface). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate multi-mode operation, for example by adding a semi-automated mode to the existing AED mode, in a device according to the teachings of Volpe, as taught by Webster, as: a) Webster suggests this would make the use of the device “more comfortable for a longer time” (abstract), and b) allowing for a semi-automated mode would permit a more experienced user to take over the attempt to rescue the user with a single device. It is noted here that this modification would also add yet another type of determination that the subject is operating the defibrillator, by selection of the fully automated AED (According to Applicant this would sufficiently meet the determination that the subject is operating the device, see instant specification ¶¶16, and 79).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20080306562 by Donnelly teaches defibrillator devices which authenticate a user based on touch input and ECG matching. The claims do not require identifying a user, thus Donnelly is not currently applied.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796