DETAILED ACTION
Claims 1-9 are pending and hereby under examination.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 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, 8, and 9, the claims all perform an “outputting” step. For example, claims 1 and 9 are directed to outputting an autoregulatory pattern, claim 3 is directed to outputting an image, and claim 8 is directed to outputting an alarm. However, there is no disclosure or claim of a display or structure for output of this data. Where is this data output to? For examination purposes, the “outputting” step will be interpreted as the data being generated or calculated. Claims 2-8 are also rejected due to their dependence on claim 1.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is
directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without
significantly more.
Analysis of independent claims 1 and 9:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a system, which describes one of the four statutory categories of
patentable subject matter, i.e., a machine.
Claim 9 is directed to a computer implemented method, which describes one of the four statutory categories of patentable subject matter, i.e., a method.
Therefore, further consideration is necessary regarding claims.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1 and 9 recite an abstract idea. In particular, the claims generally recite
the following:
group each data point in the first data set according to a plurality of blood pressure ranges to generate a plurality of data groups respectively corresponding to the plurality of blood pressure ranges;
calculate a plurality of average values of the blood flow velocity respectively corresponding to the plurality of data groups;
perform a first linear regression operation on the plurality of average values of the blood flow velocity to generate a first regression line;
calculate a first slope of the first regression line to obtain a first indicator;
group a plurality of data sets comprising the first data set according to the first indicator to generate a plurality of autoregulatory pattern groups; and
determine that the second data set corresponds to one of the plurality of autoregulatory pattern groups.
These elements recited in claims 1 and 9 are drawn to an abstract idea since they are directed towards mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
“group each data point in the first data set according to a plurality of blood pressure ranges to generate a plurality of data groups respectively corresponding to the plurality of blood pressure ranges” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably group blood pressure measurements into groups. There is nothing to suggest an undue level of complexity in this step.
“calculate a plurality of average values of the blood flow velocity respectively corresponding to the plurality of data groups” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably calculate an average of blood flow velocity measurements. There is nothing to suggest an undue level of complexity in this step.
“perform a first linear regression operation on the plurality of average values of the blood flow velocity to generate a first regression line” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably create a linear regression line on a dataset. There is nothing to suggest an undue level of complexity in this step.
“calculate a first slope of the first regression line to obtain a first indicator” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could calculate the slop of a line to obtain an indicator. There is nothing to suggest an undue level of complexity in this step.
“group a plurality of data sets comprising the first data set according to the first indicator to generate a plurality of autoregulatory pattern groups” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could group datasets based on an indicator. There is nothing to suggest an undue level of complexity in this step.
“determine that the second data set corresponds to one of the plurality of autoregulatory pattern groups” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could compare a new dataset to another dataset. There is nothing to suggest an undue level of complexity in this step.
Prong Two: Claims 1 and 9 do not recite additional elements that integrate the exception
into a practical application. Therefore, the claims are "directed to" the abstract idea. The additional
elements merely:
Add insignificant extra-solution activity (the pre-solution activity of: using generic data gathering components (e.g., "receive a first data set through the transceiver, wherein a data point in the first data set comprises blood pressure and blood flow velocity corresponding to the blood pressure" (claim 1), "receive a second data set through the transceiver" (claim 1), “receiving a first data set, wherein a data point in the first data set comprises blood pressure and blood flow velocity corresponding to the blood pressure” (claim 9), and “receiving a second data set” (claim 9)); the post-solution activity of: (e.g. “output an autoregulatory pattern of the second data set, wherein the autoregulatory pattern corresponds to one of the plurality of autoregulatory pattern groups” (claim 1) and “outputting an autoregulatory pattern of the second data set, wherein the autoregulatory pattern corresponds to one of the plurality of autoregulatory pattern groups” (claim 9))).
As a whole, the additional elements merely serve to gather information to be used by the
abstract idea, while generically implementing it on a computer. There is no practical application because
the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed
remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the
technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the
abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 9 do not include additional elements, alone or in combination, that are
sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the
same reasons as described above. E.g., all elements are directed to implementing the abstract ideas on
generic processing components, the pre-solution activity of using generic data-gathering components,
and generic post-solution activities, which merely facilitate the abstract idea.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and
conventional.
For example, "a transceiver” as disclosed in Applicant’s specification paragraph 0023 “The transceiver 130 transmits and receives signals in a wireless or wired manner. The transceiver 130 can also perform operations such as low noise amplification, impedance matching, frequency mixing, up or down frequency conversion, filtering, amplification, and the like”.
Further, “a processor” does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d
1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014)) and/or a claim to an
abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric PowerGroup, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014); SAP Am. v. lnvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a
practical application and do not amount to significantly more than the above-judicial exception (the
abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing
that is not already present when looking at the elements taking individually. There is no indication that
the combination of elements improves the functioning of a computer, for example, or improves any
other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of
elements include a particular solution to a computer-based problem or a particular way to achieve a
desired computer-based outcome. Rather, the collective functions of the claimed invention merely
provide conventional computer implementation, i.e., the computer is simply a tool to perform the
process.
Analysis of the dependent claims:
Claims 2-8 depend from the independent claims. Dependent claims 2-8 merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“calculate cerebrovascular resistance based on the blood pressure and the blood flow velocity; calculate a plurality of average values of the cerebrovascular resistance respectively corresponding to the plurality of data groups; perform a second linear regression operation on the plurality of average values of the cerebrovascular resistance to generate a second regression line; calculate a second slope of the second regression line to obtain a second indicator; and group the plurality of data sets according to the first indicator and the second indicator to generate the plurality of autoregulatory pattern groups” (claim 2), “calculate a plurality of standard deviations of the blood flow velocity respectively corresponding to the plurality of average values of the blood flow velocity” (claim 3), “wherein each data point in the first data set corresponds to each heartbeat of a subject” (claim 6), and “perform an interpolation operation on the first data set to up-sample the first data set” (claim 7)),
Further describe the pre-solution activity (“communicatively connect to an ultrasonic instrument through the transceiver, and receive the blood flow velocity of the data point from the ultrasonic instrument” (claim 4) and “communicatively connect to a sphygmomanometer through the transceiver, and receive the blood pressure of the data point from the sphygmomanometer” (claim 5)), and
Further describe the post-solution activity (“generate an image based on the plurality of average values of the blood flow velocity and the plurality of standard deviations of the blood flow velocity; and output the image” (claim 3) and “output an alert message, in response to determining that the second data set corresponds to one of the plurality of autoregulatory pattern groups” (claim 8)).
Taken alone or in combination, the additional elements do not integrate the judicial exception
into a practical application at least because the abstract idea is not applied, relied on, or used in a
meaningful way. The additional elements do not add anything significantly more than the abstract idea.
The collective functions of the additional elements merely provide computer/electronic implementation
and processing, and no additional elements beyond those of the abstract idea. There is no indication
that the combination of elements permits automation of specific tasks that previously could not be
automated. There is no indication that the combination of elements improves the functioning of a
computer, output device, improves technology other than the technical field of the claimed invention, etc. The result of the abstract idea does not cause the computing device and/or application to perform
different. The result of the abstract idea does not cause output of the user-accessible output. The user-
accessible output does not cause or confirm that the user adjusts their posture. Therefore, the claims
are rejected as being directed to non-statutory subjection matter.
Claims 1-9 are rejected.
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.
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.
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 1-6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Chi et. al. (“Impaired cerebral autoregulation is associated with poststroke cognitive impairment”), hereinafter Chi, and Liu et. al. (“Cerebral Autoregulation of Blood Velocity and Volumetric Flow during Steady-State Changes in Arterial Pressure RR”), hereinafter Liu.
Regarding claim 1, Chi discloses an electronic device for evaluating an autoregulatory pattern of cerebral blood flow, comprising:
a transceiver; and
a processor, coupled to the transceiver (While a processor and a transceiver are not explicitly stated in Chi, Examiner notes that Chi states the CBF and BP are measured from a Doppler ultrasonography monitor and finger plethysmography, respectively. The data is then transferred to MATLAB for analysis (Page 2, paragraph 7 – Page 3, paragraph 1). Thus, the transceiver and processor are inherent to these steps of receiving data and processing the data), and configured to:
receive a first data set through the transceiver, wherein a data point in the first data set comprises blood pressure and blood flow velocity corresponding to the blood pressure (Page 2, paragraph 7 – Page 3, paragraph 1, wherein BP and CBF were measured for dynamic cerebral autoregulation assessment);
group each data point in the first data set according to a plurality of blood pressure ranges to generate a plurality of data groups respectively corresponding to the plurality of blood pressure ranges (Page 4, paragraph 2, wherein the data was split between controls and patients with/without PSCI);
calculate a plurality of average values of the blood flow velocity respectively corresponding to the plurality of data groups (Page 4, paragraph 2, wherein the average values of each dynamic CA index was calculated);
group a plurality of data sets comprising the first data set according to the first indicator to generate a plurality of autoregulatory pattern groups (Page 2, paragraph 7 – Page 4, paragraph 1, patients with and without PSCI);
receive a second data set through the transceiver, and determine that the second data set corresponds to one of the plurality of autoregulatory pattern groups (Page 2, paragraph 7 – Page 4, paragraph 1, wherein comparing initial datasets from control/patients with datasets obtained a year later; Fig. 2); and
output an autoregulatory pattern of the second data set, wherein the autoregulatory pattern corresponds to one of the plurality of autoregulatory pattern groups (Page 5, paragraph 2, wherein impaired CA is determined).
While Chi discloses performing a regression (Page 5, paragraph 2), Chi fails to disclose performing a first linear regression operation on the plurality of average values of the blood flow velocity to generate a first regression line and calculating a first slope of the first regression line to obtain a first indicator.
However, Liu teaches using cerebral blood flow and arterial pressure to measure cerebral autoregulation and impaired CA (Abstract), wherein a linear regression is performed on blood flow, blood flow velocity, and cardiovascular resistance parameters to determine a slope. Liu discusses that different slopes indicate intact or impaired autoregulation (Page 3, paragraph 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chi in measuring cerebral autoregulation to incorporate the teachings of Liu to calculate indicators indicative of intact or impaired autoregulation.
Regarding claim 2, Chi fails to disclose the limitations of calculating a cerebrovascular resistance (CVR), averaging CVR, and performing linear regression on CVR values to calculate a slope.
However, Liu teaches calculating cerebrovascular resistance based on the blood pressure and the blood flow velocity (Page 3, paragraph 4);
calculate a plurality of average values of the cerebrovascular resistance respectively corresponding to the plurality of data groups (While Liu fails to explicitly disclose calculating a plurality of average values of cerebrovascular resistance, Liu discloses averaging values of blood flow and blood pressure. It is within the ability of one of ordinary skill in the art to calculate average values of cerebrovascular resistance measurements);
perform a second linear regression operation on the cerebrovascular resistance values to generate a second regression line (Page 3, paragraph 5);
calculate a second slope of the second regression line to obtain a second indicator (Fig. 2); and
group the plurality of data sets according to the first indicator and the second indicator to generate the plurality of autoregulatory pattern groups (Page 3, paragraph 5 – Page 4, paragraph 7, wherein the data was determined to be “impaired CA” or “intact CA”).
Liu discusses that calculating and using cerebrovascular resistance is important as it is an important indicator for assessing cerebral autoregulation (Page 5, paragraph 4). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chi and Liu to incorporate the teachings of Liu to calculate cerebrovascular resistance to assess cerebral autoregulation.
Regarding claim 3, Chi further discloses calculating a plurality of standard deviations of the blood flow velocity respectively corresponding to the plurality of average values of the blood flow velocity (Page 4, paragraph 2, wherein data is expressed as means and standard deviations);
generating an image based on the plurality of average values of the blood flow velocity and the plurality of standard deviations of the blood flow velocity; and outputting the image (While Chi does not explicitly disclose generating an image based on averages and standard deviations, Chi does create tables and figures depicting measurements taken of CBF and BP (Fig. 2), and one of ordinary skill would be capable of taking the measurements, the averages and standard deviations of said measurements, and outputting/displaying them).
Regarding claim 4, Chi further discloses communicatively connecting to an ultrasonic instrument through the transceiver, and receive the blood flow velocity of the data point from the ultrasonic instrument (Page 2, paragraph 7, wherein the blood flow velocity is obtained by a Doppler ultrasonography monitor).
Regarding claim 5, Chi further discloses communicatively connecting to a blood pressure monitor through the transceiver, and receive the blood pressure of the data point from the blood pressure monitor (Page 2, paragraph 7 – page 3, paragraph 1). Examiner notes that while Chi discloses communicating with a blood pressure monitor, Chi fails to explicitly disclose connecting to a sphygmomanometer. However, as per MPEP 2114 "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Thus, the limitation of communicatively connecting to another device for obtaining a blood pressure, whether that device is a sphygmomanometer or a plethysmography device, does not change the way the claimed apparatus is intended to be employed. Thus, Chi meets the claim limitation.
Regarding claim 6, Chi further discloses wherein each data point in the first data set corresponds to each heartbeat of a subject (Page 2, paragraph 7, wherein BP is measured over 5 min).
Regarding claim 8, Chi discloses outputting an alert message, in response to determining that the second data set corresponds to one of the plurality of autoregulatory pattern groups (Page 5, paragraph 2, wherein impaired CA is determined based on the comparisons between the measurements at different time periods).
Regarding claim 9, Chi discloses a method for evaluating an autoregulatory pattern of cerebral blood flow, comprising:
receiving a first data set, wherein a data point in the first data set comprises blood pressure and blood flow velocity corresponding to the blood pressure (Page 2, paragraph 7 – Page 3, paragraph 1, wherein BP and CBF were measured for dynamic cerebral autoregulation assessment);
grouping each data point in the first data set according to a plurality of blood pressure ranges to generate a plurality of data groups respectively corresponding to the plurality of blood pressure ranges (Page 4, paragraph 2, wherein the data was split between controls and patients with/without PSCI);
calculating a plurality of average values of the blood flow velocity respectively corresponding to the plurality of data groups (Page 4, paragraph 2, wherein the average values of each dynamic CA index was calculated);
grouping a plurality of data sets comprising the first data set according to the first indicator to generate a plurality of autoregulatory pattern groups (Page 2, paragraph 7 – Page 4, paragraph 1, patients with and without PSCI);
receiving a second data set, and determine that the second data set corresponds to one of the plurality of autoregulatory pattern groups (Page 2, paragraph 7 – Page 4, paragraph 1, wherein comparing initial datasets from control/patients with datasets obtained a year later; Fig. 2); and
outputting an autoregulatory pattern of the second data set, wherein the autoregulatory pattern corresponds to one of the plurality of autoregulatory pattern groups (Page 5, paragraph 2, wherein impaired CA is determined).
While Chi discloses performing a regression (Page 5, paragraph 2), Chi fails to disclose performing a first linear regression operation on the plurality of average values of the blood flow velocity to generate a first regression line and calculating a first slope of the first regression line to obtain a first indicator.
However, Liu teaches using cerebral blood flow and arterial pressure to measure cerebral autoregulation and impaired CA (Abstract), wherein a linear regression is performed on blood flow, blood flow velocity, and cardiovascular resistance parameters to determine a slope. Liu discusses that different slopes indicate intact or impaired autoregulation (Page 3, paragraph 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chi in measuring cerebral autoregulation to incorporate the teachings of Liu to calculate indicators indicative of intact or impaired autoregulation.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Chi and Liu as applied to claim 1 above, and further in view of Hofmann (US 20240221157).
Regarding claim 7, Chi as modified fails to disclose interpolating the data.
However, Hofmann teaches a method for providing supply data, wherein blood pressure (Paragraph 0043) and blood flow (Paragraph 0058) are calculated and an interpolation can be performed (Paragraph 0065). Hofmann discusses this is useful to describe behavior of different parameters, for example blood flow, in data not previously measured (Paragraph 0065). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chi and Liu to incorporate the interpolation of Hofmann to describe parameters at different values not previously measured.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hsu et. al. (“Correlations among critical closing pressure, pulsatility index and cerebrovascular resistance”).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791