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 .
Amendment Entered
In response to the amendment filed on May 11th, 2026, amended claims 1-14 are entered. Claims 1-10 remain withdrawn from consideration. Claims 11-14 are currently under examination.
Response to Arguments
Applicant's remarks and amendments with respect to the claim objection have been fully considered. The objection is withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejection under 35 U.S.C. 112(b) have been fully considered. The rejection is withdrawn in view of the amendment.
Applicant's arguments, filed on May 11th, 2026, with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive. The rejections are maintained, and further clarified, in view of the amendment.
At Pgs. 11-12 of the Reply, Applicant argues that “the features recited in Claim 11 cannot practically be performed in the human mind”. Examiner respectfully disagrees and would like to clarify that the abstract idea can be performed in the human mind, while the other steps of measuring the physiological parameter using the sensor and the means for applying a pressure to the artery are considered as pre-solution activity and data-gathering. This is recognized by the court as insignificant, extra-solution activity. “As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978)” MPEP 2106.05(g). Furthermore, outside of the data-gathering steps of receiving the signals, the claims recite mental processes performed on a computer control system. The claimed steps of applying and estimating can be performed via pen and paper or in a person’s mind with no time limit given the signal data. The computer is merely utilized as a tool to perform the mental steps.
At Pgs. 12-13 of the Reply, Applicant argues “Claim 1 recites additional elements that integrate any purported abstract idea into a practical application”. Examiner respectfully disagrees. The current claims do not have any limitations drawn to performing any decisions, procedures, or steps in response to the estimations. The claim language simply estimates the data using models and obtained data. Thus, there is nothing outside of the abstract idea that shows integration into practical application in the current claims.
Furthermore, the claimed steps do not improve the functioning of the data acquisition or the signal exchange. “It is important to note, the judicial exception alone cannot provide the improvement.” MPEP 2106.05(a). The data acquisition and signal exchange appear to perform the same with or without the abstract idea. Therefore, any improvement resides solely within the abstract idea.
“The full scope of the claim under the BRI should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification).” MPEP 2106.05(a). “That is, the claim must include the components or steps of the invention that provide the improvement described in the specification.” Id.
“[I]n McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea.” MPEP 2106.05 (a). In this case, there is no improvement to a computer or other technology. Unlike McRO, the claimed system invokes a computer as a tool to perform a mathematical concept and/or mental process.
The computing device and units perform the same with or without the claimed abstract idea. Therefore, it is unclear how the abstract idea can improve the standard functions of the additional elements.
Further at Pg. 13 of the Reply, Applicant argues “Claim 11 is directed to a device having embedded components that can be attached to the arm of a patient”, which makes the element not generic. Examiner respectfully disagrees. The device having “embedded components that can be attached to the arm of a patient” does not differentiate it from elements that are well-understood, routine, and conventional in the art. In fact, measuring blood pressure using the arm of a patient is one of the most well-understood, routine, and conventional ways to do so. Furthermore, blood pressure is usually measured using a device having “embedded components”, instead of multiple different components separate from one another.
At Pg. 14 of the Reply, Applicant argues that “the Office does not evaluate the claim as a whole”. Examiner respectfully disagrees. Under Step 2B, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the abstract idea, the claim recites additional steps of data-gathering (receiving physiological information from a sensor). These steps are each recited at a high level of generality such that they amount to insignificant pre-solution activity. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and storing engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as “sensor(s)” and use of a hardware “processing circuitry” does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)). Thus, the claimed invention does not amount to significantly more than the abstract idea.
At Pgs. 14-15 of the Reply, Applicant argues that “Claim 11 clearly integrated any purported abstract idea into a practical application” as the “sensor, the means for applying the pressure and the processing circuitry are integral to determining the arterial pressure of the patient”. Examiner would like to clarify that they are aware and agree that the sensor, the means for applying the pressure, and the processing circuitry are integral to determining the arterial pressure of the patient. However, this still does not integrate the abstract idea into a practical application as it still recites steps for data-gathering, along with a determination step that would be considered a mental process. The newly added limitations still recite mental steps for sensing data, analyzing content, estimating parameter using data obtained through generic sensors.
Applicant's remarks and amendments with respect to the rejection under 35 U.S.C. 102 have been fully considered. The rejection is withdrawn in view of the amendment.
Claim Objections
Claims 11 and 14 are objected to because of the following informalities:
Claim 11 recites “device to be attached to a patient” in line 1, but should read “device configured to be attached to a patient”
Claim 14 recites “applying a pressure” in lines 2-3, but should read “applying the pressure”
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.
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 11-14 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 11 recites “based on (1) the pressure applied by the means for applying at each calibration time of a plurality of calibration times, (2) the physiological parameter measured by the sensor at each calibration time of the plurality of calibration times, and (3) a reference pressure, (a) determine the transmural pressure at each calibration time, and (b) determine a calibration function defining the transmural pressure as a function of the physiological parameter” in lines 9-14. It is unclear as to whether the determinations of (a) transmural pressure and (b) calibration function are each based on all three components (1)-(3), or if the determination of (a) may be based on one or two elements from the three components while the determination of (b) may be based on another one or two elements from the three components. Clarification is requested.
Claim 11 recites “an external pressure applied at the single measurement time by the means for applying” in lines 19-20. It is unclear as to whether this limitation is referring to the previously recited “variable pressure” in line 7, “the pressure applied by the means for applying” in line 9, or a separate element.
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 11-14 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.
Each of Claims 11-14 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 11-14 recite a device to be attached to a patient to estimate an arterial pressure of the patient. Thus, the claims are directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 11-14 recites at least one step or instruction for estimating an arterial pressure of the patient, which is grouped as a mental process under the 2019 PEG. Claims 11-14 recite abstract ideas in the form of mental processes. If a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind, see Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016). The steps of determining a transmural pressure and calibration functions and estimating transmural pressure and arterial pressure may be performed by the human mind. This applies for all claims dependent on independent Claim 11. Accordingly, each of Claims 11-14 recites an abstract idea.
Specifically, Claim 11 recites the abstract idea of:
“based on (1) the pressure applied by the means for applying at each calibration time of a plurality of calibration times, (2) the physiological parameter measured by the sensor at each calibration time of the plurality of calibration times, and (3) a reference pressure, (a) determine the transmural pressure at each calibration time, and (b) determine a calibration function defining the transmural pressure as a function of the physiological parameter,
apply a value of the physiological parameter measured by the sensor at a single measurement time, the value being an input to the calibration function, so as to estimate, from the output of the calibration function, the transmural pressure at the single measurement time, and
based on the estimated transmural pressure and an external pressure applied at the single measurement time by the means for applying, estimate the arterial pressure of the patient”.
Further, dependent Claims 12-14 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in independent Claim 11 (identified above) is not integrated into a practical application under 2019 PEG because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: “sensor”, “means for applying a pressure”, “processing circuitry” in independent Claim 11; “pressure sensor” in dependent Claim 12; “acoustic sensor”, “optical sensor”, “tonometric sensor”, impedance sensor”, “electromechanical sensor” in dependent Claim 13; and “strap” in dependent Claim 14 are generically recited elements which do not improve the functioning of a computer, or any other technology or technical field and/or serve as data-gathering elements. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claim 11 (and its dependent Claims 12-14) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., “processing circuitry” as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 11 (and its dependent Claims 12-14) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claim 11 (and its dependent Claims 12-14) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 11-14 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “sensor”, “means for applying a pressure”, “processing circuitry” in independent Claim 11; “pressure sensor” in dependent Claim 12; “acoustic sensor”, “optical sensor”, “tonometric sensor”, impedance sensor”, “electromechanical sensor” in dependent Claim 13; and “strap” in dependent Claim 14. The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks and/or serve as data-gathering elements. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by: the Applicant’s specification (e.g. paragraphs [0036]-[0046]), which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. determining, establishing, applying, and estimating), and the other additional elements are categorized as generic data-gathering, which are well-understood, routine, and conventional activities previously known to the pertinent industry; and the Applicant’s “Technical Field” and “Prior Art” Sections in the Specification.
Accordingly, in light of Applicant’s specification, the claimed term “processing circuitry” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “processing circuitry”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 11-14 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus of Claims 11-14 is directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 11-14 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claim 11 (and its dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 11-14 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 11-14 amounts to significantly more than the abstract idea itself. Accordingly, Claims 11-14 are not patent eligible and rejected under 35 U.S.C. 101.
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.
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over McCombie et al (U.S. Publication No. 2010/241011; cited by Applicant) in view of Hilgers et al (U.S. Publication No. 2021/0282712).
Regarding Claim 11, McCombie discloses a device to be attached to a patient to estimate an arterial pressure of the patient (Apparatus and methods for adaptive and autonomous calibration of pulse transit time measurements to obtain arterial blood pressure using arterial pressure variation; Abstract), the device comprising:
a sensor (proximal sensor 20) configured to be applied facing an artery of the patient (a PPG signal which was derived from the ulnar artery at the left wrist…proximal sensor 20 is a wristwatch sensor; [0040-0041]; Figure 2), and configured to measure a physiological parameter of the patient (the experiment was separated into two different stages: throughout stage one of the experiment (0<t<30 sec.), PPG and EKG measurements were collected with the external contact pressure of the wrist and finger PPG sensor held constant at the initial pressure provided by the elastic bands 27. At the onset of stage two of the experiment (t=30 sec.), the external sensor pressure Pw(t), applied by the wrist sensor to the measurement site was increased by applying a direct force to the sensor housing 25. This direct force was held constant and applied throughout stage two of the experiment (30 sec.<t<60 sec.). Care was taken to keep the external wrist sensor pressure below the mean arterial pressure through observation of the wrist PPG waveform morphology…the change in pulse transit time between the two stages was observed in PTT measurements estimated from the difference of the arrival time of the finger PPG waveform minimum and the peak time of the QRS complex of the EKG waveform. This allowed for an evaluation of the effect on PTT produced by an increase in wrist sensor contact force by increasing the external pressure along a segment of the arterial path leading to the finger PPG signal, while the contact pressure of the finger sensor used to estimate pulse onset was not varied; [0041-0042]; Pulse transit times were estimated during each stage as the timing difference between the minimum of the finger PPG waveform and the peak of the QRS complex of the EKG waveform. A mean pulse transit time, wrist PPG magnitude, and finger PPG magnitude were estimated using the last twenty seconds of data measured during each stage of the experiment. A set of sample results from these experiments are presented in FIG. 7…the pulse transit time data is directly correlated with the wrist sensor PPG amplitude data. This correlation suggests that 1) the change in pulse transit time is a function of the magnitude of transmural pressure applied to the ulnar artery by the wrist sensor housing and 2) this relationship, like PPG magnitude, appears to be governed by the non-linear compliance of the vessel wall; [0050-0052]; [0067]; Figure 7), the physiological parameter passing through an extremum when a transmural pressure of the artery is zero (As described above, identification of pwv0 using external pressure variation requires measurement of the transmural pressure acting across the arterial wall underlying the banded segment. Estimation of the transmural pressure can be achieved using the concepts behind oscillometry which estimates the transmural pressure by locating the zero transmural pressure point through an alteration of either the external or internal arterial pressure. This alteration can be achieved using an inflatable cuff which increases the external pressure above the mean arterial pressure or using height variation…according to the oscillometric method the maximum volumetric pulsation in the artery occurs when the transmural pressure acting across the wall is zero. For a sensor at heart level this pressure is achieved when the external arterial pressure equals the mean arterial blood pressure (Pmean). The zero transmural pressure point for the arterial segments underlying the sensor housings can be reached and identified from the PPG sensor signal with sensor height variation. As the height of the sensor is altered relative to the heart the zero transmural pressure point can be identified as the height (hmax) at which the maximum PPG signal pulsations are observed; [0076-0077]; [0052]);
means for applying a pressure to the artery of the user, configured to apply a variable pressure to the artery of the patient (The experimental protocol was as follows; an EKG signal, a PPG signal which was derived from the ulnar artery at the left wrist, and a digital artery PPG signal derived at the base of the little finger of the left hand were measured simultaneously. Both the wrist and finger PPG sensors were attached to the subject with an elastic band which caused the plastic sensor housings that contained the sensor components to exert contact pressures to the skin surface at the two measurement sites, at the wrist: Pw(t=0)…the contact pressure exerted by the sensor housings caused an increase in the external pressure being applied to the wall of the arterial segment underlying the sensor housings…PPG and EKG measurements were collected with the external contact pressure of the wrist and finger PPG sensor held constant at the initial pressure provided by the elastic bands 27; [0040-0041]; the test consisted of 6 different stages in which contact force on the wrist sensor was increased at each successive stage and held constant for a 30 second period. A sketch of the external sensor pressures implemented in the protocol is shown in FIG. 6; [0049]); and
processing circuitry connected to the sensor (processor; [0018-0019]), and configured to
based on (1) the pressure applied by means for applying at each calibration time of a plurality of calibration times ([0040-0041]; [0049]), (2) the physiological parameter measured by the sensor at each calibration time of the plurality of calibration times (The change in pulse transit time between the two stages was observed in PTT measurements estimated from the difference of the arrival time of the finger PPG waveform minimum and the peak time of the QRS complex of the EKG waveform; [0042]; 6 different stages in which contact force on the wrist sensor was increased at each successive stage and held constant for a 30 second period. A sketch of the external sensor pressures implemented in the protocol is shown in FIG. 6. Pulse transit times were estimated during each stage as the timing difference between the minimum of the finger PPG waveform and the peak of the QRS complex of the EKG waveform. A mean pulse transit time, wrist PPG magnitude, and finger PPG magnitude were estimated using the last twenty seconds of data measured during each stage of the experiment. A set of sample results from these experiments are presented in FIG. 7; [0049-0050]), and (3) a reference pressure (The external pressure applied by the finger sensor housing 28 was held constant at the initial stage 1 pressure during stage 2…this allowed for an evaluation of the effect on PTT produced by an increase in wrist sensor contact force by increasing the external pressure along a segment of the arterial path leading to the finger PPG signal, while the contact pressure of the finger sensor used to estimate pulse onset was not varied. If the magnitude and morphology of the finger PPG signal remain constant across both stages of the experiment, then it may be inferred that an increase in pulse transit time must be the result of a decrease in pulse wave velocity through the externally pressurized arterial segment; [0041-0042]), (a) determine the transmural pressure at each calibration time (The results presented in this section demonstrate that a reduction in transmural pressure imposed by the wrist sensor housing on an intermediate arterial segment of the transit path plays a significant role in determining the velocity of the propagating pulse along this path. Further, the magnitude of the change in pulse wave velocity depends on the transmural pressure of the arterial segment and that the change in pulse wave velocity appears inversely correlated to the variation in the non-linear compliance of the arterial segment underlying the sensor housing. This suggests that the variation in external arterial pressure through an alteration in the skin contact pressure applied by a sensor housing, band, or cuff is a powerful tool that can be used to predictably alter PTT and calibrate the relationship between PTT and arterial blood pressure; [0053]),
apply a value of the physiological parameter measured by the sensor at a single measurement time, the value being an input to the calibration function, so as to estimate, from the output of the calibration function, the transmural pressure at the single measurement time (The height variation was used to identify the transmural pressures acting across the arterial walls at the sensor measurement sites and to identify the model parameter k; [0084]), and
based on the estimated transmural pressure and an external pressure applied at the single measurement time by means for applying, estimate the arterial pressure of the patient (The variation in external pressure between the two stages was used to identify the model parameter pwv0 in equation (5). After identification of the two model parameters an initial mean arterial pressure estimate can be made and which allows the remainder of the unknown parameters in (5) to be identified. Given all the parameters in equation (5) this expression can be transformed to allow estimation of mean arterial blood pressure from future pulse transit time measurements; [0084]),
wherein the reference pressure is the pressure applied to the artery, during a calibration time of the plurality of calibration times, when the physiological parameter measured by the sensor reaches the extremum ([0041-0042]).
McCombie fails to specifically disclose (b) determining a calibration function defining the transmural pressure as a function of the physiological parameter.
In a similar technical field, Hilgers teaches a physiological sensor apparatus (Abstract), comprising
based on (1) the pressure applied by means for applying at each calibration time of a plurality of calibration times, (2) the physiological parameter measured by the sensor at each calibration time of the plurality of calibration times, and (3) a reference pressure, (b) determining a calibration function defining the transmural pressure as a function of the physiological parameter (The transmural pressure (Pt) of the artery is equal to the difference between the internal pressure (Pi) of the artery and the external pressure (Pe) being exerted upon the artery (Pt=Pi−Pe); [0007-0009]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the transmural pressure function teachings of Hilgers into the invention of McCombie in order to incorporate the physiological parameter into the calculation in order to avoid arterial damage and prevent arterial wall collapse (Luo [0013]).
Regarding Claim 12, McCombie discloses wherein the device further comprises a pressure sensor configured to measure the external pressure applied to the artery by the means for applying the pressure to the artery of the patient, the pressure sensor being embedded in the device and connected to the processing circuitry (the apparatus has a pressure sensor for measuring external pressure at least at a specified position along the single arterial path between the sensors; [0019]; a pressure may be sensed, by means of a pressure sensor, or a pressure may be applied, at a position along the pulse transit path, inclusive of the endpoints of the path; [0037]; The external pressure acting on an artery can be measured through the use of a pressure sensor imbedded in the band or cuff which has the capability to measure the contact pressure that the band or cuff is applying to the skin surface; [0070]).
Regarding Claim 13, McCombie discloses wherein the sensor is an acoustic sensor, an optical sensor (Each of the sensors is a photo-plethysmographic sensor, illustrated by way of example, and each has a source 24 of light (in this case, a light-emitting diode (LED)) and a photodetector 26; [0041]), a tonometric sensor, an impedance sensor, or an electromechanical sensor.
Regarding Claim 14, McCombie discloses wherein the sensor is configured to be held around a limb of the patient (proximal sensor 20 is a wristwatch sensor; [0041]) by a strap (elastic bands 27), the means for applying a pressure to the artery of the patient being integrated into the strap or secured to the strap (The experimental protocol was as follows; an EKG signal, a PPG signal which was derived from the ulnar artery at the left wrist, and a digital artery PPG signal derived at the base of the little finger of the left hand were measured simultaneously. Both the wrist and finger PPG sensors were attached to the subject with an elastic band which caused the plastic sensor housings that contained the sensor components to exert contact pressures to the skin surface at the two measurement sites, at the wrist: Pw(t=0)…the contact pressure exerted by the sensor housings caused an increase in the external pressure being applied to the wall of the arterial segment underlying the sensor housings…PPG and EKG measurements were collected with the external contact pressure of the wrist and finger PPG sensor held constant at the initial pressure provided by the elastic bands 27; [0040-0041]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHANEL J YOON/Examiner, Art Unit 3791
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