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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06DEC2022; 20JAN2023; & 13MAY20247 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
Acronym (TOI) as cited in the specification in relation to Figure 1 Parts 11 & 5 is not defined. The acronym’s full meaning is not found.
Term “A1” as seen in Figures 4-6 is not discloses in the specification.
Appropriate correction is required.
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 unit” in Claim 1;
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 “unit” 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. 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.
“light input unit” in Claim 2;
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 “light input 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 “unit” 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. Paragraph 0022 of the Specification states “The light input unit 31 includes, for example, a laser diode, a light emitting diode (LED), or a super luminescent diode (SLD), and a driving circuit for the diode.” Therefore, for the purpose of examination the examiner is interpreting this as a light emitting diode.
“calculation unit” in Claim 2;
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 “calculation 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 “unit” 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. Paragraph 0017 of the specification states “he NIRS sensor 3 and the TOT calculation unit 5 constitute a TOT measurement unit 11 in the present embodiment. The TOT measurement unit 11 measures a numerical value related to a tissue oxygen saturation (tissue oxygenation index: TOT) in a body (for example, head) of the patient, which varies due to repetition of chest compression, and displays the measurement result on the display”. This is the closest found description of the calculation unit. For the purpose of examination, the examiner is interpreting the calculation unit as a processor.
“electrical shock unit” 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 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 “unit” 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. For the purposes of examination, the examiner is interpreting this as an AED.
“information notification unit” in Claim 4;
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 “information notification 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 “unit” 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. Paragraph 0049 of the Specification states “The display monitor 10 and the speaker are examples of the information notification unit in the present embodiment.”. Therefore, for the purpose of examination the examiner is interpreting this as a display.
“oxygen saturation measurement unit” in Claims 1-2 & 4;
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 “oxygen saturation 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 “unit” 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 “oxygen saturation measurement unit” is described in ¶0007 of the Specification, no specific device is named. For the purpose of examination, the examiner is interpreting this as an infrared sensor.
“light detector” in Claim 2;
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 “light detector”, 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 “unit” 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. The specification does not contain mention of a light detector. For the purpose of examination, the examiner is interpreting this as a photo diode per ¶0025 of the Specification.
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 Claim 1:
Claim limitation “electrocardiogram measurement unit” is described in ¶0007, ¶0082, & ¶0087 of the Specification, but no specific device 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 2:
Claim limitation “calculation unit” is described in Paragraph 0017 of the specification states “he NIRS sensor 3 and the TOT calculation unit 5 constitute a TOT measurement unit 11 in the present embodiment. The TOT measurement unit 11 measures a numerical value related to a tissue oxygen saturation (tissue oxygenation index: TOT) in a body (for example, head) of the patient, which varies due to repetition of chest compression, and displays the measurement result on the display”. This is the closest found description of the calculation unit. For the purpose of examination, the examiner is interpreting the calculation unit as a processor. 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.
Claim limitation “light detector” is not found in the specification. There is not mentions of a light detector, though there are of a light detection unit. The specification does not contain mention of a light detector, and therefore, the claim lacks written description.
Regarding Claim 3:
Claim limitation “electrical shock unit” 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.
Regarding Claims 1-2 & 4:
Claim limitation “oxygen saturation measurement unit” Though the “oxygen saturation measurement unit” is described in ¶0007 of the Specification, no specific device 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 independent claim 1.
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 unit” 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 2:
Claim limitation “calculation unit” 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. Paragraph 0017 of the specification states “he NIRS sensor 3 and the TOT calculation unit 5 constitute a TOT measurement unit 11 in the present embodiment. The TOT measurement unit 11 measures a numerical value related to a tissue oxygen saturation (tissue oxygenation index: TOT) in a body (for example, head) of the patient, which varies due to repetition of chest compression, and displays the measurement result on the display”. This is the closest found description of the calculation unit. For the purpose of examination, the examiner is interpreting the calculation unit as a processor. 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.
Claim limitation “light detector” 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. There is not mentions of a light detector, though there are of a light detection unit. The specification does not contain mention of a light detector. For the purposes of examination, the light detector is being interpreted as a photosensor per ¶0023 of the specification which describes seemingly related light detection 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.
Regarding Claim 3:
Claim limitation “electrical shock unit” 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. 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.
Regarding Claim 4:
Claim limitation “information notification unit” 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. Paragraph 0049 of the Specification states “The display monitor 10 and the speaker are examples of the information notification unit in the present embodiment.”. Therefore, for the purpose of examination the examiner is interpreting this as a display. 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.
Regarding Claims 1-2 & 4:
Claim limitation “oxygen saturation measurement unit” 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. For the purpose of examination, the examiner is interpreting this as a sensor. 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 independent claim 1.
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 2 & 7-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 7 is directed to a method and thus meets the step 1 requirements.
Claim 2 is directed to an apparatus and thus meets the step 1 requirements.
Step 2A – Prong 1
Regarding claim 7, the following step is an abstract idea: “determining whether an electrical shock is required for the patient based on a measurement result of the electrocardiogram.”, which is mental processes when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could determine whether an electrical shock is required for the patient based on a measurement result of the electrocardiogram by observing the Electrocardiogram data for certain activity.
Regarding claim 2, the following step is an abstract idea: “calculate the numerical value related to the oxygen saturation based on the detection signal”, which is mental processes when given its broadest reasonable interpretation as well as a mathematical calculation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could determine whether an electrical shock is required for the patient based on a measurement result of the electrocardiogram by observing the Electrocardiogram data for certain activity.
Step 2A – Prong 2
Regarding claim 7, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea: “starting acquisition of a numerical value related to an oxygen saturation of a patient”; and “measuring an electrocardiogram of the patient on the condition that the numerical value related to the oxygen saturation exceeds a threshold value”. The limitations of “starting acquisition of a numerical value related to an oxygen saturation of a patient”; and “measuring an electrocardiogram of the patient on the condition that the numerical value related to the oxygen saturation exceeds a threshold value” are data gathering steps, which amount to no more than insignificant extra-solution activity, as well as collecting data that is necessary to implement the abstract idea on a computer or perform the methods.
Regarding claim 2, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea: “light input unit configured to input measurement light into a body of the patient”; “a light detector configured to detect the measurement light propagated in the body of the patient”, and” generate a detection signal according to an intensity of the measurement light”.
Step 2B
Regarding claim 7 the abstract idea does not amount to significantly more than the abstract idea itself. The following claim elements do not add any meaningful limitation to the abstract idea: “starting acquisition of a numerical value related to an oxygen saturation of a patient”; and “measuring an electrocardiogram of the patient on the condition that the numerical value related to the oxygen saturation exceeds a threshold value”. None of the above features amounts to more than what is well-understood, routine, and conventional.
Regarding claim 2 the abstract idea does not amount to significantly more than the abstract idea itself. The following claim elements do not add any meaningful limitation to the abstract idea: “light input unit”; “a light detector”, and” generate a detection signal according to an intensity of the measurement light”. None of the above features amounts to more than what is well-understood, routine, and conventional.
Dependent claims 8-12 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 7. The dependent claim limitations are directed to generic component functions necessary to implement the abstract idea (Claim 8), further defining data analysis limitations (Claims 11-12) data analysis (Claims 8-10), and displaying results or information (Claim 10) which are insignificant extra-solution activity. None of the above features amounts to more than what is well-understood, routine, and conventional.
Claim 9 is rejected under 101 though it has the therapy step based on guidance found in MPEP 2111.04, II:
“The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B. The broadest reasonable interpretation of a system (or apparatus or product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur. The system claim interpretation differs from a method claim interpretation because the claimed structure must be present in the system regardless of whether the condition is met and the function is actually performed. ”
While the therapy step is contingent in the system, it still has to perform it so requires the therapy step. However, the BRI of the method can be without the therapy step (the contingent limitation is not required if the determination does not indicate it is needed)
In summary, claims 2 & 7-12 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
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) in view of Volpe et al. (US Publication No. 20190275335 ).
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: an oxygen saturation measurement unit 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.”); an electrocardiogram measurement unit 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 unit on the condition that the numerical value acquired in and oxygen saturation measurement unit exceeds a threshold value. Volpe in a similar field of endeavor of verification of cardiac arrhythmia prior to therapeutic stimulation teaches starting an electrocardiogram measurement of a patient in the electrocardiogram measurement unit on the condition that the numerical value acquired in and oxygen saturation measurement unit exceeds a threshold value. (Volpe Figure 6A Showing that there are two steps where analysis of biometrics happen, both of which can be either biometric data (i.e saturation) and/or the ecg data prior to delivering a therapy. This shows the processing can be configured for evaluating oxygen levels (per ¶0130 “Analyze pulse ox data to determine whether the patient's blood oxygen saturation is above a configurable threshold value, within a configurable range of values, or has deviated from a baseline beyond a threshold value.”) and then evaluating the ecg data prior to this).
Before the effective filing date, one of ordinary skill in the art would think to combine the system of Maeda with the processing of Volpe 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 oxygen saturation measurement unit includes: a light input unit(Maeda Figure 2 Light emitting unit 24); a light detector configured to detect the measurement light propagated in the body of the patient (Maeda Figure 2 Light receiving unit 25), and generate a 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. ”); and a calculation unit(Maeda Figure 2 Measurement unit 27) configured to calculate 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 3, claim 1 is unpatentable over Maeda in view of Volpe. Maeda further discloses an electrical shock unit (Maeda AED 10 as shown in Figure 1.), wherein the electrical shock unit 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 unit (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 an information notification unit (Maeda Figure 2 Display unit 13), wherein the information notification unit configured to notify a rescuer that chest compression for the patient should be continued when the numerical value acquired by the oxygen saturation measurement unit 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 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 (Maeda ¶0027 “measurement unit 27 measures oxygen saturation rSO2 and a hemoglobin index HbI of intracerebral blood.”); and determining 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 starting an electrocardiogram measurement of a patient in the electrocardiogram measurement unit on the condition that the numerical value acquired in and oxygen saturation measurement unit exceeds a threshold value. Volpe in a similar field of endeavor of verification of cardiac arrhythmia prior to therapeutic stimulation teaches starting an electrocardiogram measurement of a patient in the electrocardiogram measurement unit on the condition that the numerical value acquired in and oxygen saturation measurement unit exceeds a threshold value. (Volpe Figure 6A Showing that there are two steps where analysis of biometrics happen, both of which can be either biometric data (i.e saturation) and/or the ecg data prior to delivering a therapy. This shows the processing can be configured for evaluating oxygen levels (per ¶0130 “Analyze pulse ox data to determine whether the patient's blood oxygen saturation is above a configurable threshold value, within a configurable range of values, or has deviated from a baseline beyond a threshold value.”) and then evaluating the ecg data prior to this).
Before the effective filing date, one of ordinary skill in the art would think to combine the system of Maeda with the processing of Volpe 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 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
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/MEGAN T FEDORKY/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796