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.
Claims 1, 3-8, 10-14, and 17-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea(s) without significantly more.
Regarding Claim 1, analyzed as the representative claim:
[Step 1] Claim 1 recites “A evaluation apparatus…” which falls within the “machine” statutory category of invention under 35 U.S.C. § 101.
[Step 2A – Prong 1] Claim 1 recites “An evaluation apparatus for chest compression, comprising: a measuring unit configured to obtain numerical values relating to temporal changes in a total hemoglobin concentration, an oxygenated hemoglobin concentration, and a deoxygenated hemoglobin concentration in a head, which vary due to repetition of the chest compression; a compression position evaluation unit configured to calculate a first indicator and a second indicator based on the numerical values and determine whether a compression position on a sternum is appropriate based on the first indicator and the second indicator, the first indicator relating to a temporal change ratio of one or both of the oxygenated hemoglobin concentration and the deoxygenated hemoglobin concentration with respect to a temporal change in the total hemoglobin concentration, and the second indicator relating to a correlation between a temporal change in the oxygenated hemoglobin concentration and a temporal change in the deoxygenated hemoglobin concentration; and an instruction unit configured to instruct to change the compression position in a case where the compression position on the sternum is inappropriate.” The bolded limitations, under their broadest reasonable interpretation, encompass mental processes (including observation, evaluation, judgment, and opinion) or methods of organizing human activity (managing personal behavior or relationships or interactions between people – including social activities, teaching, and following rules or instructions). That is, other than reciting that the steps are performed by “a compression position evaluation unit” or “an instruction unit,” nothing in the claim precludes the steps from practically being performed by a human and/or in the human mind. Specifically, the claim encompasses a human performing calculations based on obtained data and determining/instructing to change a compression position based on the results of those calculations.
Accordingly, the claim recites an abstract idea(s).
[Step 2A – Prong 2] The judicial exception is not integrated into a practical application. Specifically, the claim recites the additional element of a program executing on a computing device for performing the method steps, wherein the computing device and executed computer program are recited at a high level of generality and merely automate the calculating and instructing steps. Therefore, this additional element amounts to no more than mere instructions to apply the exception using a generic computing device, which does not impose any meaningful limits on practicing the abstract idea(s). Thus, the claim is directed to an abstract idea(s).
[Step 2B] The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea(s) into a practical application, the additional element of a computer program executing on a computing device for performing the method steps amounts to no more than mere instructions to apply the exception using a generic computing device, which cannot provide an inventive concept. Accordingly, representative claim 1 is not patent eligible.
Claims 3-8 are dependent on representative claim 1 and include all of the limitations of claim 1. Therefore, these dependent claims recite the same abstract idea(s) as those recited in the independent claim or contain limitations drawn to generic computer components and/or reciting extra solution activities. While these dependent claims may have a narrower scope than the representative claim, no claim contains an additional element to integrate the abstract idea(s) into a practical application or to render an inventive concept that transforms the corresponding claim into a patent eligible application of the otherwise ineligible abstract idea(s). Thereby, claims 2-9 are also 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 7-13, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0258381 (hereinafter “Ozaki”), and further in view of US 2019/0029919 (hereinafter “Suh”).
Regarding Claim 1 and related method Claim 10, Ozaki discloses a measuring unit configured to obtain numerical values relating to temporal changes in a total hemoglobin concentration, an oxygenated hemoglobin concentration, and a deoxygenated hemoglobin concentration in a head, which vary due to repetition of the chest compression (par. 0031: “the concentration measurement apparatus 1 measures respective temporal variations (relative change amounts) from initial amounts of total hemoglobin (cHb) concentration, oxygenated hemoglobin (O2Hb) concentration, and deoxygenated hemoglobin (HHb) concentration of the head 51 that vary due to repeated chest compression");
a compression position evaluation unit configured to calculate a first indicator and a second indicator based on the numerical values and determine whether a compression position on a sternum is appropriate based on the first indicator and the second indicator (fig. 1; par. 0083: “making an objective judgment of whether or not chest compression is being performed appropriately can be indicated by determining at least one of the respective relative change amounts (ΔcHb, ΔO2Hb) of the total hemoglobin concentration and oxygenated hemoglobin concentration";” par. 0031: “To provide material for objectively judging whether or not chest compression (arrow A in the figure) is being performed appropriately;” Examiner notes the underlined portions will be addressed below), the first indicator relating to a temporal change ratio of one or both of the oxygenated hemoglobin concentration and the deoxygenated hemoglobin concentration with respect to a temporal change in the total hemoglobin concentration (par. 0031: “respective temporal variations (relative change amounts) from initial amounts of total hemoglobin (cHb) concentration, oxygenated hemoglobin (O2Hb) concentration, and deoxygenated hemoglobin (HHb) concentration;” par. 0088: “the ratio AΔcHb/( AΔO2Hb + AΔHHb)”), and the second indicator relating to a correlation between a temporal change in the oxygenated hemoglobin concentration and a temporal change in the deoxygenated hemoglobin concentration (par. 0031: “respective temporal variations (relative change amounts) from initial amounts of… oxygenated hemoglobin (O2Hb) concentration, and deoxygenated hemoglobin (HHb) concentration of the head 51”); and
an instruction unit configured to instruct to change the compression position in a case where the compression position on the sternum is inappropriate (fig. 1; par. 0031: “objectively judging whether or not chest compression (arrow A in the figure) is being performed appropriately… and displays the measurement results on a display section 15 to notify a person performing the chest compression;” Examiner reiterates the underlined portion will be addressed immediately below).
Ozaki discloses an apparatus which determines whether sternal compressions are appropriate and effective, which would inherently include whether the compression position is appropriate (because an appropriate sternal compression cannot comprise an inappropriate compression position) but does not explicitly disclose as such. However, Suh explicitly and specifically discloses determin[ing] whether a compression position on a sternum is appropriate (par. 0014: “the processor may be configured to determine whether a current compression site compressed by the chest compressor is an optimal compression site, based on the bio signal measured by the bio signal measurement unit”) and instruct[ing] to change the compression position in a case where the compression position on the sternum is inappropriate (par. 0037: “the chest compressor 110 may find an optimal compression site at which the cardiac output becomes the maximum, and may move to the optimal compression site under control of the processor;” Examiner interprets that the processor determines when a compression position is inappropriate and then issues the instruction to change position). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the specific determination of proper compression position of Suh with the determination of proper overall compression of Ozaki in order to provide a method of more specifically determining whether one particular element of the chest/sternal compression is appropriate (Suh, pars. 0014-0015).
Regarding Claim 2 and related method Claim 16, Ozaki further discloses a light incidence portion configured to make measurement light incident on the head (par. 0010: “a light incidence section making measurement light incident on the head”);
a light detection portion configured to detect the measurement light that has propagated through the head (par. 0010: “a light detection section detecting the measurement light that has propagated through the interior of the head”) and generate a detection signal corresponding to an intensity of the measurement light (par. 0010: “generating a detection signal in accordance with the intensity of the detected measurement light”); and
a calculation portion configured to calculate the numerical values based on the detection signal (par. 0010: “a calculation section determining, based on the detection signal, a correlation coefficient of a first temporal relative change amount of the oxygenated hemoglobin concentration and a second temporal relative change amount of the deoxygenated hemoglobin concentration and a polarity of a slope of a regression line of the first relative change amount and the second relative change amount").
Regarding Claim 3 and related method Claim 11, Ozaki further discloses the compression position evaluation unit is configured to perform first linear regression based on the numerical values by using a numerical value relating to a pulse wave component of the total hemoglobin concentration as an explanatory variable and a numerical value relating to a pulse wave component of the oxygenated hemoglobin concentration as an objective variable (figs. 9-13 (a)), use a regression coefficient value obtained by the first linear regression as the first indicator (pars. 0073-0074: “the slope k of the regression line… may be determined by the above-described formula (9) for the time series data of the temporal relative change amount of the total hemoglobin concentration (ΔcHb) as x1 to xn and the time series data of the temporal relative change amount of the oxygenated hemoglobin concentration (ΔO2Hb) as y1 to yn. The oxygen saturation SO2 is calculated as SO2=k×100(%);” Examiner notes the slope k is considered to be the first indicator), perform second linear regression, based on the numerical values, between the numerical value relating to a pulse wave component of the oxygenated hemoglobin concentration and a numerical value relating to a pulse wave component of the deoxygenated hemoglobin concentration (figs. 9-13 (b)), and use a determination coefficient value obtained by the second linear regression as the second indicator (pars. 0078-0079: “the correlation coefficient R2… of the regression line B accurately express the phase shift between the oxygenated hemoglobin concentration and the deoxygenated hemoglobin concentration… the magnitude of the correlation coefficient R2 to enable the accuracy of calculation of the amplitude of the total hemoglobin concentration and the oxygen saturation and the possibility of reverse direction blood transmission from the vena cava to the head to be evaluated easily based on the phase shift between the oxygenated hemoglobin concentration and the deoxygenated hemoglobin concentration;” Examiner notes the correlation coefficient R2 is considered to be the second indicator).
Regarding Claim 4 and related method Claim 12, Ozaki further discloses the compression position evaluation unit is configured to perform the first linear regression and the second linear regression based on the numerical values obtained during a period from a time of calculation of the first linear regression and the second linear regression to at least 5 seconds before the time of calculation (par. 0066: “scatter diagram of each of (b) in FIG. 9 to (b) in FIG. 13 are plotted 100 points resulting from measurement of the temporal relative change amounts (ΔO2Hb, ΔHHb) for 5 seconds at a sampling rate of 20 times/second. Here, time series data of at least one cycle are sufficient for determining the correlation coefficient R2 and the polarity of the slope of the regression line B to be described below;” par. 0088: “the phase difference θ is determined from the average amplitudes of the respective relative change amounts (ΔO2Hb, ΔHHb, ΔcHb) in the past 5 seconds”).
Regarding Claim 5 and related method Claim 13, Ozaki modified by Suh further discloses the compression position evaluation unit determines that the compression position on the sternum (see claim 1) is inappropriate in a case where the regression coefficient value served as the first indicator is less than a first threshold value and the determination coefficient value served as the second indicator is less than a second threshold value (Ozaki, par. 0096: “a display section displaying the oxygen saturation together with the correlation coefficient and the polarity of the slope of the regression line;” par. 0069: “the correlation coefficient and the polarity of the slope of the regression line accurately express the phase shift between the temporal relative change amount of the oxygenated hemoglobin concentration (ΔO2Hb) and the temporal relative change amount of the deoxygenated hemoglobin concentration (ΔHHb);” claim 6: “evaluate the chest compression based on the phase shift;” Examiner notes the chest compression is effectively evaluated using the two indicators, and therefore these values inherently must be compared to established thresholds in order to actually determine whether those values correlate to a proper chest compression).
Regarding Claim 7 and related method Claim 17, Ozaki discloses the second threshold value is 0 or more (pars. 0067-0069: “when the phase shift (phase difference) is 90°, the correlation coefficient R2 is substantially zero;” figs. 9-13 (b)), but does not explicitly disclose the second threshold value is 0.7 or less. However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to further modify Ozaki so that the second threshold value is 0.7 or less. The KSR Court recognized that "[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. In this particular case, there is necessarily a maximum threshold value to compare to (see claim 5 above) and the absolute maximum the second indicator can be is 1.0 (Examiner notes the maximum value of a correlation coefficient is 1.0). Therefore, there is a finite number of possible options for a maximum value. Any such option would therefore be obvious for a person having ordinary skill in the art to pursue.
Regarding Claim 8 and related method Claim 18, Ozaki further discloses the compression position evaluation unit is configured to calculate a ratio, based on the numerical values, between an amplitude of the temporal change in the total hemoglobin concentration and an amplitude of the temporal change in one or both of the oxygenated hemoglobin concentration and the deoxygenated hemoglobin concentration as the first indicator (par. 0088: “amplitudes AΔO2Hb, AΔHHb, and AΔcHb of the respective relative change amounts of the oxygenated hemoglobin concentration, deoxygenated hemoglobin concentration, and total hemoglobin concentration… the ratio AΔcHb/( AΔO2Hb + AΔHHb)… may be displayed as a parameter that serves as an approximate reference for the phase difference θ”), and calculate a difference between a phase of the temporal change in the oxygenated hemoglobin concentration and a phase of the temporal change in the deoxygenated hemoglobin concentration as the second indicator (par. 0088: “the phase difference θ is determined from the average amplitudes of the respective relative change amounts (ΔO2Hb, ΔHHb, ΔcHb) in the past 5 seconds”).
Regarding Claim 9 and related method Claim 15, Ozaki further discloses the measuring unit is configured to obtain a pulse wave component of the total hemoglobin concentration, a pulse wave component of the oxygenated hemoglobin concentration, and a pulse wave component of the deoxygenated hemoglobin concentration by applying filtering process on the numerical values to extract a component that varies due to repetition of the chest compression (par. 0040: “the CPU 14 applies a filtering process to the temporal relative change amounts (ΔO2Hb, ΔHHb, ΔcHb) to remove frequency components less than a predetermined frequency from frequency components contained in the amounts to thereby extract temporal variation components due to repetition of chest compression”), and wherein the compression position evaluation unit is configured to calculate the first indicator using the pulse wave component of the total hemoglobin concentration and one or both of the pulse wave component of the oxygenated hemoglobin concentration and the pulse wave component of the deoxygenated hemoglobin concentration (figs. 9-13 (a); pars. 0073-0074: “the slope k of the regression line… may be determined by the above-described formula (9) for the time series data of the temporal relative change amount of the total hemoglobin concentration (ΔcHb) as x1 to xn and the time series data of the temporal relative change amount of the oxygenated hemoglobin concentration (ΔO2Hb) as y1 to yn. The oxygen saturation SO2 is calculated as SO2=k×100(%)”), which are obtained by the measuring unit, and calculate the second indicator using the pulse wave component of the oxygenated hemoglobin concentration and the pulse wave component of the deoxygenated hemoglobin concentration, which are obtained by the measuring unit (figs. 9-13 (b); pars. 0078-0079: “the correlation coefficient R2… of the regression line B accurately express the phase shift between the oxygenated hemoglobin concentration and the deoxygenated hemoglobin concentration… the magnitude of the correlation coefficient R2 to enable the accuracy of calculation of the amplitude of the total hemoglobin concentration and the oxygen saturation and the possibility of reverse direction blood transmission from the vena cava to the head to be evaluated easily based on the phase shift between the oxygenated hemoglobin concentration and the deoxygenated hemoglobin concentration”).
Claims 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ozaki in view of Suh as applied to claims 1 and 10 above, and further in view of US 2021/0212889 (hereinafter “Alsbou”).
Regarding Claim 6 and related method Claim 14, Ozaki implicitly discloses the first threshold value is 1.0 or less (par. 0074: “The oxygen saturation SO2 is calculated as S02=k×100(%);” Examiner reiterates the slope k is the first indicator, and since this value directly relates to oxygen saturation, the maximum value of k is inherently 1.0 as oxygen saturation cannot be above 100%), but does not explicitly disclose the first threshold is 0.5 or more. However, Alsbou discloses the first threshold value is 0.4 or more (fig. 11: the patient’s cerebral oxygen saturation must be above 40% for the chest compressions to be considered effective and proper; Examiner notes this would correlate to a threshold of 0.4 or more—and 1.0 or less). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) See MPEP § 2144.05-I.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the specific threshold value of Alsbou with the presumed but unspecified threshold of Ozaki in order to evaluate chest compressions using an objective value as a threshold (fig. 11).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2018/0110667 (Freeman) teaches a chest compression device which seeks the optimal sternal location and uses data including oxygenated and deoxygenated hemoglobin concentration.
US 2021/0045967 (Lampe) teaches a chest compression treatment system which includes monitoring oxygenated and deoxygenated hemoglobin concentration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE DOSHER whose telephone number is (571) 272-4842. The examiner can normally be reached Monday - Friday, 10 a.m. - 6 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dmitry Suhol can be reached at (571) 272-4430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.G.D./Examiner, Art Unit 3715
/DMITRY SUHOL/Supervisory Patent Examiner, Art Unit 3715