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 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.
Claim(s) 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1- Claim 1
Claim 1 and dependent claims 2-14 are drawn to a system and thus meet the requirements for step 1.
Step 2a (prong 1) - Claim 1
Claims 1 recites the step of “calculate one heart rate and one pulse rate of the patient for each day based on the biological information” Under the broadest reasonable interpretation, this step covers a concept capable of being performed in the human mind, and thus falls within the mental processes grouping of abstract ideas. Other than reciting the method is “computer-implemented” in the preamble, nothing in the claim precludes the step from practically being performed in the mind.
Accordingly, claim 1 recites an abstract idea.
Step 2a (prong 2) – Claim 1
The judicial exception is not integrated into a practical application. Claim 1 recites the additional elements of:
a biological information acquisition means configured to acquire biological information of a patient including a heart rate of one or more opportunities and a pulse rate of one or more opportunities of a patient to be managed for each day is insignificant extra-solution activity (i.e., data gathering),
a daily measurement value calculation means configured to calculate one heart rate and one pulse rate of the patient for each day based on the biological information is insignificant extra-solution activity (i.e., data gathering), and
a medical care assistance image generation means configured to generate a medical care assistance image including a heart rate/pulse rate graph in which the one heart rate and one pulse rate for each day are plotted in one graph area having a time for one axis and a rate for another axis is insignificant extra-solution activity (i.e. data gathering/statistics).
an output means configured to output the medical care assistance image is recited at a high level of generality (i.e., as generic devices, a “computer-implemented” method, performing generic computer functions like sending, receiving, and visually displaying data) is insignificant extra-solution activity (i.e., data output).
These steps do not integrate the abstract idea into a practical application because they are insignificant extra solution activity.
Step 2b- Claim 1
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, providing a (medical care assistance image) is recited at a high level of generality (i.e., as generic devices, a “computer-implemented” method, performing generic computer functions like sending, receiving, and visually displaying data). Further, a biological information acquisition means configured to acquire biological information of a patient including a heart rate of one or more opportunities and a pulse rate of one or more opportunities of a patient to be managed for each day is considered data gathering.
The additional elements that were considered insignificant extra solution activity have been re-analyzed and do not amount to anything more than what is well-understood, routine and conventional when considered individually and in combination with evidence provided. Specifically:
a biological information acquisition means configured to acquire biological information of a patient including a heart rate of one or more opportunities and a pulse rate of one or more opportunities of a patient to be managed for each day is well understood, routine, and conventional (i.e., receiving data MPEP 2106.05(d)(II)).
a daily measurement value calculation means is well-understood routine and conventional (i.e., gathering data/statistics MPEP 2106.05(d)(II)).
a medical care assistance image generation means is well-understood routine and conventional (i.e., gathering data/statistics MPEP 2106.05(d)(II)).
an output means configured to output the medical care assistance image is considered to be well-understood, routine, and conventional (i.e., presenting data MPEP 2106.05(d)(II)).
Claim 1 is thus consider to be directed to an abstract idea without significantly more.
Claims 2-14 depend from claim 1. The type of data analyzed as stated in claims 2-3 and 10-11 are considered extra solution activity. The devices utilized to collect the data as stated in claims 4-9 and 13-14 are stated at a high level of generality in applicant’s specification (“a smart watch; a touchpad device; a steering wheel; a smart handheld device; a waveform analysis kiosk; and a connected device”) and are merely used as a tool to carry out the data gathering/statistics. Claim 12 is directed to the extra solution activity of presenting the data. Thus, the dependent claim do not change the overall analysis that claims 2-14 are also directed to an abstract idea.
Claim 15 is rejected under 35 U.S.C. 101 because it is directed to non-statutory subject matter. The claim recites “a recording medium”. While this may encompass statutory media (e.g. Hard Drive, CD), its scope also includes non-statutory transitory signals. Because the claim’s scope covers both statutory and non-statutory embodiments, it encompasses ineligible subject matter and is thus ineligible under Step 1 of the eligibility analysis. It is suggested to add “non-transitory” to the claim.
Claim Rejections - 35 USC § 112(b)
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 14-15 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.
Claim 14 recites the limitation “the biological information acquisition means; the daily measurement value calculation means; and the medical care assistance image generation means, the medical care assistance device constituting at least a part of the medical care assistance system according to claim 1” There is insufficient antecedent basis for this limitation in the claim.
For purposes of examination, “the” will be interpreted as “a/an.”
Claim 15 is rejected as it depends from claim 14.
Furthermore, claim 14 is also indefinite as it is unclear if the devices recited are the same or different/new as the devices found in claim 1. It is unclear how the device is different from the system of claim 1 if they contain all of the same components/devices of claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(f)
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.
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.
Claim(s) 1-7, 10 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (U.S. Pub. 2023/0301577 herienafter “Liu”) in view of McNamara et al. (U.S. Pub. 2010/0268103 hereinafter “McNamara”).
Regarding claim 1, Liu discloses a medical care assistance system (e.g. Fig. 1) comprising: a biological information acquisition means (e.g. 10) configured to acquire biological information of a patient including a heart rate of one or more opportunities and a pulse rate of one or more opportunities of a patient to be managed for each day (e.g. Fig. 5, “1”; ¶98); a daily measurement value calculation means (e.g. 20; “processor”) configured to calculate heart rate and pulse rate of the patient based on the biological information and a predetermined calculation rule (e.g. Fig. 5; “2”); a medical care assistance image generation means (e.g. 20; “processor”) configured to generate a medical care assistance image including a heart rate/pulse rate graph in which the one heart rate and one pulse rate for each day are plotted in one graph area having a time for one axis and a rate for another axis (e.g. Fig. 5, “3”; ¶98); and an output means (e.g. 30) configured to output the medical care assistance image. Liu discloses the claimed invention except for the system generating and displaying a single value for each day. However, McNamara teaches that it is known to calculate a single value and display it for each day as set forth in Figures 5-6 to provide a means for summarizing and showing patterns and trends over multiple days on a single screen for review by a user/doctor. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Liu, with the daily summarization as taught by McNamara, since such a modification would provide the predictable results of providing a means for summarizing and showing patterns and trends over multiple days on a single screen for review by a user/doctor.
Regarding claim 2, meeting the limitations of claim 1 above, Liu further discloses wherein the biological information includes the presence or absence of atrial fibrillation, and the medical care assistance image generation means generates the medical care assistance image including the heart rate/pulse rate graph plotted together with a heart rate when the atrial fibrillation is detected (e.g. see Figs. 5-6 and ¶98).
Regarding claim 3, meeting the limitations of claim 1 above, Liu further discloses wherein the medical care assistance image generation means generates, when the atrial fibrillation is present, the medical care assistance image in which a mark indicating the presence of the atrial fibrillation is also displayed on the heart rate/pulse rate graph (e.g. see Fig. 2).
Regarding claim 4, meeting the limitations of claim 1 above, Liu further discloses wherein the biological information acquisition means also acquires the presence or absence of arrhythmia of the patient for each day (e.g. Fig. 5; “2”), and the medical care assistance image generation means generates, when the arrhythmia is present, the medical care assistance image in which a mark indicating the presence of the arrhythmia is also displayed on the heart rate/pulse rate graph (e.g. see Fig. 2).
Regarding claim 5, meeting the limitations of claim 1 above, McNamara further discloses wherein the daily measurement value calculation means determines, with respect to the heart rate and the pulse rate in the one opportunity, a measurement value of first measurement as a measurement value of the one opportunity when further measurement is not performed within 10 minutes from the first measurement, or determines an average value of all measurement values performed within 10 minutes as the measurement value of the one opportunity when further measurement is performed within 10 minutes from the first measurement (e.g. ¶40; “wherein the measurement is taken every 10 mins.”).
Regarding claim 6, meeting the limitations of claim 1 above, McNamara further discloses wherein when the biological information acquisition means acquires the heart rate and the pulse rate at a plurality of measurement opportunities per one day (e.g. ¶40; “wherein the measurement is taken every 10 mins.”), the daily measurement value calculation means selects one opportunity from the plurality of measurement opportunities and calculates the one heart rate and the one pulse rate for each day based on measurement values of the heart rate and the pulse rate in the selected opportunity (e.g. ¶40; “wherein the measurement is taken every 10 mins.”).
Regarding claim 7, meeting the limitations of claim 1 above, Liu further discloses wherein the daily measurement value calculation means selects a measurement opportunity at a predetermined timing as the one opportunity in the one day, and calculates the one heart rate and the one pulse rate based on a measurement value measured at the one opportunity (e.g. see Figs. 5-6 and ¶98).
Regarding claim 10, meeting the limitations of claim 1 above, McNamara further discloses wherein when the biological information acquisition means acquires the heart rate and the pulse rate at a plurality of measurement opportunities per one day and acquires a plurality of the heart rates or the pulse rates in each opportunity (e.g. ¶40; “wherein the measurement is taken every 10 mins.”), the daily measurement value calculation means selects a measurement opportunity in which a difference between a plurality of the heart rates or between a plurality of the pulse rates acquired in each opportunity is the smallest as the one opportunity in the one day, and calculates the one heart rate and the one pulse rate based on a measurement value measured at the one opportunity (e.g. ¶40; “wherein the measurement is taken every 10 mins.”).
Regarding claim 14, meeting the limitations of claim 1 above, Liu further discloses a medical care assistance device comprising: the biological information acquisition means (e.g. 10); the daily measurement value calculation means (e.g. 20; “processor”); and the medical care assistance image generation means (e.g. 20; “processor”), the medical care assistance device constituting at least a part of the medical care assistance system according to claim 1.
Regarding claim 15, meeting the limitations of claim 1 above, Liu further discloses a program recording medium (e.g. 20; “processor”) for causing a computer to function as the medical care assistance device according to claim 14.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of McNamara as applied to claims 1-7, 10 and 14-15 above, and further in view of Mandel-Portnoy et al. (U.S. Pub. 2020/0113472 hereinafter “Mandel-Portnoy”).
Regarding claims 8-9, Liu in view of McNamara discloses the claimed invention except for the system takes the measurement to determine normal or pulse deficits. However, Mandel-Portnoy teaches that it is known to sense and determine if the data is likely to be normal or a pulse deficit as set forth in Figure 6 and Paragraphs 26, 51 and 53 to provide a means for sensing normal and pulse deficits to determine possible risks to be displayed to the user. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Liu in view of McNamara, with pulse deficit detection as taught by Mandel-Portnoy, since such a modification would provide the predictable results of a means for sensing normal and pulse deficits to determine possible risks to be displayed to the user.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of McNamara as applied to claims 1-7, 10 and 14-15 above, and further in view of Walker (U.S. Pub. 2020/0253820).
Regarding claims 11-13, Liu in view of McNamara discloses the claimed invention except for the system determining and alerting the user to measurement states that adversely affect the data. However, Walker teaches that it is known to sense and determine if the data is likely to have artifacts and then displays to the user if the data has artifacts as set forth in Paragraphs 20, 81-82, 206, 209 and 211 to provide a means for making sure that the most accurate and reliable data is displayed to the user. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Liu in view of McNamara, with artifact sensing and alerting as taught by Walker, since such a modification would provide the predictable results of providing a means for determining artifacts and displaying them to make sure that the most accurate and reliable data is displayed to the user.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/ Primary Examiner, Art Unit 3796
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