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 .
Status of Claims
The amendments and remarks filed on 17JUN2026 have been entered and considered.
Claims 1-4, 7, & 9 are amended.
Claims 1-2 are under examination.
Response to Arguments
Applicants’ arguments filed 17JUN2026 regarding the specification objections have been fully considered and have been found to obviate the objections. Therefore, the specification objections have been withdrawn.
Applicants’ amendments filed 17JUN2026 regarding the claim interpretations have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
The amendments for “electrocardiogram measurement unit” are insufficient to obviate the 112(f) interpretation and is therefore maintained.
The amendments for “light input unit” obviates the interpretation. Therefore, the 112(f) interpretation has been withdrawn.
The amendments for “calculation unit” obviates the interpretation. Therefore, the 112(f) interpretation has been withdrawn.
The amendments for “light detector” obviate the interpretation. Therefore, the 112(f) interpretation has been withdrawn.
The amendments for “electrical shock source” are insufficient to obviate the 112(f) interpretation and is therefore maintained.
The amendments for “information notification unit” obviates the interpretation. Therefore, the 112(f) interpretation has been withdrawn.
The amendments for “oxygen saturation measurement unit” obviates the interpretation. Therefore, the 112(f) interpretation has been withdrawn.
Applicant's amendments and arguments filed 17JUN2026 regarding the rejections under 35 USC 112(a) have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Pages 6-7 of the Remarks):
In the Office Action, the Examiner provided general allegations that various limitations are not adequately described by the specification. The Examiner, however, has failed to present any evidence or reasoning to rebut the presumption of adequate written description. This lack of evidence or reasoning clearly establishes that the Examiner failed to establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would allegedly not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed. Therefore, without the Examiner providing further evidence, Applicant respectfully submits that the rejection is improper. Further, in the interest of expediting prosecution in this case, Applicant respectfully submits that claims 1-4 have been amended in view of the Examiner's comments. Applicant respectfully submits that claims 1-6 now even more fully satisfy the requirements of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. If the Examiner continues to maintain such a rejection, Applicant respectfully requests that the Examiner provide evidence or reasoning that allegedly establishes a lack of adequate written description. In any case, Applicant respectfully requests that the rejection be withdrawn.
The amendments for “electrocardiogram measurement unit” are insufficient to obviate the 112(a) rejection and is therefore maintained.
The amendments for “light detector” obviate the rejection. Therefore, the 112(a) rejection has been withdrawn.
The amendments for “calculation unit” obviates the rejection. Therefore, the 112(a) rejection has been withdrawn.
The amendments for “electrical shock source” are insufficient to obviate the 112(a) interpretation and is therefore maintained.
The amendments for “oxygen saturation measurement unit” obviates the rejection. Therefore, the 112(a) rejection has been withdrawn.
Applicant's amendments filed 17JUN2026 regarding the rejections under 35 USC 112(b) have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
The amendments for “electrocardiogram measurement unit” are insufficient to obviate the 112(b) rejection and is therefore maintained.
The amendments for “electrical shock source” are insufficient to obviate the 112(b) interpretation and is therefore maintained.
The amendments for “information notification unit” obviates the 112(b) interpretation and the rejection is therefore withdrawn.
The amendments for “oxygen saturation measurement unit” obviates the 112(b) interpretation and the rejection is therefore withdrawn.
Applicants’ amendments filed 17JUN2026 regarding the rejections under 35 USC 101 have been fully considered and have been found to obviate the rejection. Therefore, the rejection has been withdrawn.
Applicants’ arguments/amendments filed 17JUN2026 regarding the rejections under 35 USC 103(a) have been fully considered and have been found to be persuasive. Therefore, a new ground of rejection can be found below with Maeda et al. (US Publication No. 20170259075; Previously Cited) in view of Heikkila (US Publication No. 20200008675).
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:
“Electrocardiogram measurement machine” in Claims 1 & 3;
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Claim limitation “electrocardiogram measurement unit”, has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because they use a generic placeholder “machine” coupled with functional language without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation. Though the “electrocardiogram measurement unit” is described in ¶0007, ¶0082, & ¶0086 of the Specification, no specific device is named, nor is there any disclosure of the electrocardiogram machine or corresponding structure. For the purpose of examination, the examiner is interpreting this as an ECG sensor since the claim only requires that this unit acquires ECG data, where the ECG data processing is disclosed in Claims 1 & 3 to be done by the controller rather than the electrocardiogram measurement machine.
“electrical shock source” in Claim 3;
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Claim limitation “electrical shock source”, has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because they use a generic placeholder “source” coupled with functional language without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation. ¶0015-¶0016 are the only known disclosure of an electrical shock unit in the specification. These paragraphs name the unit but do not provide a description of what the electrical shock unit consists of. Further, the electrical shock source as newly amended is not found in the specification. For the purposes of examination, the examiner is interpreting this as an AED.
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 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.
Claims 1-6 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 claim(s) contains 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.
Regarding Claims 1 & 3:
Claim limitation “electrocardiogram measurement machine” is not found in the specification. The electrocardiogram measurement unit is discussed in the specification but no structure is named. MPEP §2181, IV states “Merely restating a function associated with a means-plus-function limitation is insufficient to provide the corresponding structure for definiteness. See, e.g., Noah, 675 F.3d at 1317, 102 USPQ2d at 1419; Blackboard, 574 F.3d at 1384, 91 USPQ2d at 1491; Aristocrat, 521 F.3d at 1334, 86 USPQ2d at 1239. It follows therefore that such a mere restatement of function in the specification without more description of the means that accomplish the function would also likely fail to provide adequate written description under section 112(a) or pre-AIA section 112, first paragraph.”. Therefore, the claim lacks written description.
Claims 2-6 are further rejected for depending upon rejected claim 1.
Regarding Claim 3:
Claim limitation “electrical shock source” are mentioned in the specification in ¶0015-¶0016, which are the only known disclosures of an electrical shock unit. These paragraphs name the unit but do not provide a description of what the electrical shock unit consists of. For the purposes of examination, the examiner is interpreting this as an AED. MPEP §2181, IV states “Merely restating a function associated with a means-plus-function limitation is insufficient to provide the corresponding structure for definiteness. See, e.g., Noah, 675 F.3d at 1317, 102 USPQ2d at 1419; Blackboard, 574 F.3d at 1384, 91 USPQ2d at 1491; Aristocrat, 521 F.3d at 1334, 86 USPQ2d at 1239. It follows therefore that such a mere restatement of function in the specification without more description of the means that accomplish the function would also likely fail to provide adequate written description under section 112(a) or pre-AIA section 112, first paragraph.”. Therefore, the claim lacks written description.
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 1-6 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.
Regarding Claims 1 & 3:
Claim limitation “electrocardiogram measurement machine” 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. Though the “electrocardiogram measurement unit” is described in ¶0007, ¶0082, & ¶0086 of the Specification, no specific device is named, and it is unclear what the electrocardiogram measurement unit is. For the purpose of examination, the examiner is interpreting this as an ECG sensor since the claim only requires that this unit acquires ECG data, where the ECG data processing is disclosed in Claim 1 to be done by the controller rather than the electrocardiogram measurement unit. 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.
Claims 2-6 are further rejected for depending upon rejected claim 1.
Regarding Claim 3:
Claim limitation “electrical shock source” 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. ¶0015-¶0016 are the only known disclosure of an electrical shock unit in the specification. The newly amended el;ectrical shock source is not found in the specification. These paragraphs name the unit but do not provide a description of what the electrical shock unit consists of. For the purposes of examination, the examiner is interpreting this as an AED. 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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Maeda et al. (US Publication No. 20170259075; Previously Cited) in view of Heikkila (US Publication No. 20200008675).
Regarding claim 1, Maeda discloses an apparatus for defibrillation (Maeda Abstract “An automatic external defibrillator includes an AED body having a pair of defibrillation pads applied to a chest of a rescuee to apply an electric shock to the rescuee; and a pulse wave sensor unit connected to the AED body to detect a pulse wave in a head of the rescuee.”) comprising: a near-infrared spectroscopy sensor configured to acquire a numerical value related to an oxygen saturation of a patient (Maeda ¶0027 “measurement unit 27 measures oxygen saturation rSO2 and a hemoglobin index HbI of intracerebral blood.”; ¶0022); an electrocardiogram measurement machine configured to measure an electrocardiogram of the patient in order to determine whether an electrical shock is required for the patient (Maeda ¶0023 “ the controller 32 controls a switching unit 33, and acquires a determination result relating to whether the shock is required based on the biological information of the rescuee P such as the cardiac potential output from the defibrillation pad 16 pasted on the chest of the rescuee P, from a determination unit 34.”; Determination unit 34); and a controller(Maeda Controller 32 as seen in Figure 2).
Maeda does not disclose starting an electrocardiogram measurement of a patient in the electrocardiogram measurement machine on the condition that the numerical value acquired in and near infrared spectroscopy sensor exceeds a threshold value. Heikkila in a similar field of endeavor of sensor design and control systems teaches an oxygen sensor configured to acquire a numerical value related to an oxygen saturation of a patient (Heikkila ¶0058 “Still referring to FIG. 2B, the patch 10 further comprises an oxygen saturation measurement unit 80 comprising a first light emitter 84, a second light emitter 86 and a light detector 82. For example, the light emitters 84, 86 may be LEDs. The light detector 82 may be configured to detect light. For example, the light detector 82 may be a photodetector or a matrix detector. The light emitters 84, 86 may be configured to emit light on a first and second frequency areas respectively. That is, the first light emitter 84 may be configured to emit light having a first wavelength and the second light emitter 86 may be configured to emit light having a second wavelength. The first and second wavelengths may be different. That is, the color of light emitter by the emitters 84, 86 may be different.”...); an ECG electrode (Heikkila ¶0055 “According to an embodiment, the patch 10 comprises at least two electrodes 12-14 configured to perform ECG measurements (e.g. electrodes 12 and 14). “); and a controller (Heikkila Figure 2B Controller 30) configured to start an electrocardiogram measurement of a patient on the condition that the numerical value acquired in the oxygen sensor exceeds a threshold value. (Heikkila ¶0084 “Other events may include detecting, by the controller, a certain medical condition based on measurements using the at least two electrodes 12-14, the oxygen saturation measurement unit 80 and/or temperature sensor 60. For example, if heart rate, oxygen saturation, or temperature of the person is too low or too high, the ECG data measurement and storing may be triggered.”).
Before the effective filing date, one of ordinary skill in the art would think to combine the system of Maeda with the processing limitations of Heikkila to arrive at a device that can account for blood oxygen levels to determine if defibrillation is warranted, for the purposes of increasing the effectiveness of defibrillation, since it has been held that the oxygen saturation levels below a certain threshold will result in inadequate resuscitation results (Maeda ¶0004) .
Regarding claim 2, claim 1 is unpatentable over Maeda in view of Volpe. Maeda further discloses wherein the near-infrared spectroscopy sensor includes: a light(Maeda Figure 2 Light emitting unit 24); a photosensor configured to detect the measurement light propagated in the body of the patient (Maeda Figure 2 Light receiving unit 25), and generate a an electrical detection signal according to an intensity of the measurement light (Maeda ¶0022 “Furthermore, the controller 32 controls a light source controller 26 to emit near-infrared light from the light emitting unit 24. The controller 32 acquires biological information relating to a pulse wave measured by a measurement unit 27 based on reflected light received by the light receiving unit 25. ”); wherein the controller is further configured to calculate the numerical value related to the oxygen saturation based on the generated electrical detection signal (Maeda ¶0022 “The controller 32 acquires biological information relating to a pulse wave measured by a measurement unit 27 based on reflected light received by the light receiving unit 25”).
Regarding claim 3, claim 1 is unpatentable over Maeda in view of Volpe. Maeda further discloses an electrical shock source (Maeda AED 10 as shown in Figure 1.), wherein the electrical shock source is configured to output an electrical energy for the electrical shock from an electrode (Maeda ¶0017 “ The pair of defibrillation pads 16 may be pasted on the chest (human head) of the rescuee P, thereby acquiring biological information of the rescuee P such as a cardiac potential and applying the electric shock to the rescuee P.”; where in the citation the defibrillation pads 16 are shown as functioning as the sensing & therapeutic electrodes for the system)when it is determined that the electrical shock is required for the patient based on a measurement result of the electrocardiogram by the electrocardiogram measurement machine (Maeda ¶0023 “ the controller 32 controls a switching unit 33, and acquires a determination result relating to whether the shock is required based on the biological information of the rescuee P such as the cardiac potential output from the defibrillation pad 16 pasted on the chest of the rescuee P, from a determination unit 34.”).
Regarding claim 4, claim 1 is unpatentable over Maeda in view of Volpe. Maeda further discloses one or both of a display and a speaker, (Maeda Figure 2 Display unit 13), wherein the(Maeda ¶0014 “For example, the display unit 13 outputs a confirmed result of a state of a rescuee P or display guidance such as an operation procedure to a rescuer (not illustrated).”; ¶0066 showing that determinations are made for shockable rhythms related to oxygen saturation, where once conditions are satisfied the rescuer is instructed to stop compressions. The examiner is interpreting this as a user is expected to perform chest compressions until this notification arrives. ¶0063 further discloses that the cpr is guided by the device until a shockable rhythm is achieved.).
Regarding claim 5, claim 1 is unpatentable over Maeda in view of Volpe. Maeda further discloses wherein the threshold value is a value included in a range of 40% to 60% in terms of a temporal relative change amount of the oxygen saturation (Maeda ¶0066 “For example, when the measurement unit 27 determines that the measurement value for the oxygen saturation of the rescuee P exceeds a predetermined reference value (for example, 40%), the controller 32 uses the display unit 13 and the audio unit 14 as a notification unit to notify the rescuer to apply the shock to the rescuee P in response to the determination.”)
Regarding claim 6, claims 1 & 5 are unpatentable over Maeda in view of Volpe. Maeda further discloses wherein the threshold value is a value included in a range of 45% to 50% in terms of the temporal relative change amount of the oxygen saturation (Maeda ¶0004 “Therefore, it is also suggested that a prognosis of a resuscitated patient is improved if the chest compression is continuously performed until the intracerebral oxygen saturation reaches 40% to 50% or greater.”).
Regarding claim 7, Maeda discloses a method for defibrillation comprising (Maeda ¶0072 “ Our methods are usefully applicable to automatic external defibrillators that detect whether the chest compression is properly performed. Through the monitoring of the oxygen saturation, it is known that, in a reference value (for example, 50% or smaller), the return of spontaneous circulation (ROSC) is not often achieved by cardiopulmonary resuscitation. Accordingly, in the reference value or smaller, a less effective shock is not given to the rescuee P. In this manner, it is possible to expect an advantageous effect in that the prognosis of the resuscitated rescuee P does not become worse”) : starting acquisition of a numerical value related to an oxygen saturation of a patient with a near-infrared spectroscopy sensor (Maeda ¶0027 “measurement unit 27 measures oxygen saturation rSO2 and a hemoglobin index HbI of intracerebral blood.”; ¶0022; ¶0058); and determining by a controller whether an electrical shock is required for the patient based on a measurement result of the electrocardiogram (Maeda ¶0066 “Further, for example, the controller 32 notifies the rescuer of a state where the shock switch 15 is operable or notifies the rescuer to take steps away from the rescuee P. For example, when the measurement unit 27 determines that the measurement value for the oxygen saturation of the rescuee P exceeds a predetermined reference value (for example, 40%), the controller 32 uses the display unit 13 and the audio unit 14 as a notification unit to notify the rescuer to apply the shock to the rescuee P in response to the determination.”).
Maeda does not disclose measuring, with an electrocardiogram measurement machine, an electrocardiogram of the patient on the condition that the numerical value related to the oxygen saturation exceeds a threshold value. Heikkila in a similar field of endeavor of sensor design and control systems teaches an oxygen sensor configured to acquire a numerical value related to an oxygen saturation of a patient (Heikkila ¶0058 “Still referring to FIG. 2B, the patch 10 further comprises an oxygen saturation measurement unit 80 comprising a first light emitter 84, a second light emitter 86 and a light detector 82. For example, the light emitters 84, 86 may be LEDs. The light detector 82 may be configured to detect light. For example, the light detector 82 may be a photodetector or a matrix detector. The light emitters 84, 86 may be configured to emit light on a first and second frequency areas respectively. That is, the first light emitter 84 may be configured to emit light having a first wavelength and the second light emitter 86 may be configured to emit light having a second wavelength. The first and second wavelengths may be different. That is, the color of light emitter by the emitters 84, 86 may be different.”...); an ECG electrode (Heikkila ¶0055 “According to an embodiment, the patch 10 comprises at least two electrodes 12-14 configured to perform ECG measurements (e.g. electrodes 12 and 14). “); and a controller (Heikkila Figure 2B Controller 30) configured to start an electrocardiogram measurement of a patient on the condition that the numerical value acquired in the oxygen sensor exceeds a threshold value. (Heikkila ¶0084 “Other events may include detecting, by the controller, a certain medical condition based on measurements using the at least two electrodes 12-14, the oxygen saturation measurement unit 80 and/or temperature sensor 60. For example, if heart rate, oxygen saturation, or temperature of the person is too low or too high, the ECG data measurement and storing may be triggered.”).
Before the effective filing date, one of ordinary skill in the art would think to combine the system of Maeda with the processing limitations of Heikkila to arrive at a device that can account for blood oxygen levels to determine if defibrillation is warranted, for the purposes of increasing the effectiveness of defibrillation, since it has been held that the oxygen saturation levels below a certain threshold will result in inadequate resuscitation results (Maeda ¶0004) .
Regarding claim 8, claim 7 is unpatentable over Maeda in view of Volpe. Maeda further discloses wherein the starting the acquisition of the numerical value related to the oxygen saturation includes: performing a light input of starting input of measurement light into a body of the patient (Maeda ¶0022 “Furthermore, the controller 32 controls a light source controller 26 to emit near-infrared light from the light emitting unit 24”); performing a light detection of starting detection of the measurement light propagated in the body of the patient, and starting generation of a detection signal according to an intensity of the measurement light (Maeda ¶0022 “The controller 32 acquires biological information relating to a pulse wave measured by a measurement unit 27 based on reflected light received by the light receiving unit 25.”); and performing a calculation of starting calculation of the numerical value related to the oxygen saturation based on the detection signal (Maeda ¶0022 “The controller 32 acquires biological information relating to a pulse wave measured by a measurement unit 27 based on reflected light received by the light receiving unit 25”).
Regarding claim 9, claim 7 is unpatentable over Maeda in view of Volpe. Maeda further discloses determining, by the controller, the electrical shock is required for the patient based on the measurement result of the electrocardiogram (Maeda ¶0066 “Further, for example, the controller 32 notifies the rescuer of a state where the shock switch 15 is operable or notifies the rescuer to take steps away from the rescuee P. For example, when the measurement unit 27 determines that the measurement value for the oxygen saturation of the rescuee P exceeds a predetermined reference value (for example, 40%), the controller 32 uses the display unit 13 and the audio unit 14 as a notification unit to notify the rescuer to apply the shock to the rescuee P in response to the determination.”).; performing an electrical shock, wherein an electrical energy for the electrical shock is output from an electrode in the electrical shock (Maeda ¶0017 “ The pair of defibrillation pads 16 may be pasted on the chest (human head) of the rescuee P, thereby acquiring biological information of the rescuee P such as a cardiac potential and applying the electric shock to the rescuee P.”; where in the citation the defibrillation pads 16 are shown as functioning as the sensing & therapeutic electrodes for the system)when it is determined that the electrical shock is required for the patient in the determining (Maeda ¶0023 “ the controller 32 controls a switching unit 33, and acquires a determination result relating to whether the shock is required based on the biological information of the rescuee P such as the cardiac potential output from the defibrillation pad 16 pasted on the chest of the rescuee P, from a determination unit 34.”).
Regarding claim 10, claim 7 is unpatentable over Maeda in view of Volpe. Maeda further discloses performing an information notification, wherein the information notification notifies a rescuer that chest compression for the patient should be continued when the numerical value related to the oxygen saturation does not exceed the threshold value (Maeda ¶0014 “For example, the display unit 13 outputs a confirmed result of a state of a rescuee P or display guidance such as an operation procedure to a rescuer (not illustrated).”; ¶0066 showing that determinations are made for shockable rhythms related to oxygen saturation, where once conditions are satisfied the rescuer is instructed to stop compressions. The examiner is interpreting this as a user is expected to perform chest compressions until this notification arrives. ¶0063 further discloses that the cpr is guided by the device until a shockable rhythm is achieved.).
Regarding claim 11, claim 7 is unpatentable over Maeda in view of Volpe. Maeda further discloses wherein the threshold value is a value included in a range of 40% to 60% in terms of a temporal relative change amount of the oxygen saturation (Maeda ¶0066 “For example, when the measurement unit 27 determines that the measurement value for the oxygen saturation of the rescuee P exceeds a predetermined reference value (for example, 40%), the controller 32 uses the display unit 13 and the audio unit 14 as a notification unit to notify the rescuer to apply the shock to the rescuee P in response to the determination.”)
Regarding claim 12, claims 7 & 11 are unpatentable over Maeda in view of Volpe. Maeda further discloses wherein the threshold value is a value included in a range of 45% to 50% in terms of the temporal relative change amount of the oxygen saturation (Maeda ¶0004 “Therefore, it is also suggested that a prognosis of a resuscitated patient is improved if the chest compression is continuously performed until the intracerebral oxygen saturation reaches 40% to 50% or greater.”).
Conclusion
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 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 date of this final action.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
