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 .
Response to Amendment
The amendment filed December 23, 2025 has been entered. Claims 1, 3-15, 20-21, 23-24, 26-28, and 31 are pending. Claims 2, 16-19, 22, 25, 29, and 30 are cancelled.
Examiner acknowledges Applicant’s amendment of claims 26, 27, and 31.
Election/Restrictions
Applicant's election with traverse of claims 1, 3-15, 23, 26-28, and 31 in the reply filed on December 23, 2025 is acknowledged. The traversal is on the ground(s) that the cited art does not teach that the shared technical feature of the claims (i.e., “tissue pressure signals”).
Particularly, Applicant states that the prior art of Riobo Aboy (US 8926521) (disclosed by Applicant) (hereinafter – RA) discloses using a “cuff pressure signal” as opposed to “tissue pressure pulse curves,” and further, that no individual pulse curves are disclosed. However, the broadest reasonable interpretation of the term “tissue pressure pulse curves” are pressure waveforms that occur as a result of tissue pulsation, encompassing typical plethysmographic waveforms, or an envelope formed from features of tissue pulses. The middle two graphs shown out of the four graphs depicted in RA’s Figs. 3-6 are pulses arising from tissue pulsation, measured via cuff pressure; each pulse is identifiable and thus constitutes identification of individual pressure pulse curves. Figs. 7-10 of RA read on the secondary interpretation of “tissue pressure pulse curves” as an envelope formed from features of tissue pulses.
Assuming, in arguendo, Applicant’s narrowed definition of the phrase “tissue pressure pulse curves,” Applicant’s citation to Paragraph 0004 does not particularly differentiate RA’s individual pulse curves of Figs. 3-6 from Applicant’s definition of “tissue pressure pulse curves.” Paragraph 0004 states: “ [w]ith conventional pressure cuffs, only pressure oscillations with 90-96% loss of the actually hydraulically transcutaneous detectable tissue pressure pulse curves are measured.” Thus, using conventional cuffs, such as the cuff disclosed in RA, tissue pressure pulse curves are still measured, albeit at 90-96% loss. Thus, identification of a subset of tissue pressure pulse curves (assuming Applicant’s narrowed definition of the phrase) such as the pulses identified in RA still results in identification of what can be considered tissue pressure pulse curves. Thus, Applicant’s argument is not found persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 20, 21, and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 23, 2025.
Claim Objections
Claims 12 and 15 are objected to because of the following informalities:
In claim 12, Examiner suggests removing the term “alternative” in the phrase “alternative first systolic blood pressure value” since no initial systolic blood pressure is calculated in claim 1.
In claim 15, “DAP 1 BNi” should read as “DAP1BNi.” As currently shown in the documents, there appear to be spaces between P, 1, and BNi.
Appropriate correction is required.
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 4, 6, 15, 23, 28, and dependent claims thereof 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.
Re. Claim 4: Claim 4 recites the limitation "the diastolic blood pressure value" and “the systolic blood pressure value.” Antecedent basis is not established for these limitations in the claim.
Re. Claim 6: Claim 6 recites “the pulsation power parameter is obtained by linking at least one of a potentiated area parameter and a triple potentiated amplitude parameter.” The term “potentiated” is not provided in Applicant’s Specification. The broadest reasonable interpretation of “potentiate” is “to make more effective or active.” However, it is unclear with what context an area parameter is made more effective or active.
For purposes of examination, the limitation identified to be at issue is read instead as “the pulsation power parameter is obtained by linking at least one of an area parameter and an amplitude parameter.”
Re. Claim 15: The formula recited in claim 15 does not match the formula for calculating DAP1Bni defined in Applicant’s specification on page 20. The presently claimed formula is indefinite because it simplifies to:
DAP1Bni = k – SAP1ni
But since systolic pressure (similar to SAP1ni) is typically higher than diastolic pressure (similar to DAP1Bni), the values of k claimed are low enough in magnitude such that the calculation yields a negative value for blood pressure in any case where systolic blood pressure and diastolic blood pressure differ by more than the greatest number in each of the ranges of k1, k2, and k3.
As best understood, the equation is intended to read as:
DAP1Bni = k1*MAP1Ani – k2*(SAP1ni – MAP1Ani) – k3 mmHg, commensurate with what is shown on Applicant’s Specification at page 20.
Re. Claim 23: Claim 23 recites “wherein a fourth average blood pressure is obtained…” However, no recitation of a first, second, or third average blood pressure is recited earlier in the dependency chain. Thus, it is unclear how many average blood pressure values are required by the claims.
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, 3-15, 23, 26-28, and 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of the claims recites steps or instructions for ascertaining and processing data to measure a blood pressure of a mammal subject, which is grouped as a mental process. Accordingly, each of the claims recites an abstract idea.
Independent claim 1 recites:
A method for non-invasively determining at least one blood pressure value from a tissue pressure signal using a pressure cuff applied to an individual, the tissue pressure signal having a sequence of tissue pressure pulse curves (evaluation, observation, or judgement; additional element; details of data-gathering),
comprising: identifying at least two individual tissue pressure pulse curves in the tissue pressure signal (evaluation, observation, or judgement);
determining at least one amplitude parameter and one area parameter for each identified tissue pressure pulse curve, the amplitude parameter indicating the amplitude of the identified tissue pressure pulse curve and the area parameter indicating at least one partial area enclosed by the tissue pressure pulse curve (evaluation, observation, or judgement);
for each identified tissue pressure pulse curve, determining a pulsation power parameter indicating a shape of the tissue pressure pulse curve based on at least the amplitude parameter and the area parameter (evaluation, observation, or judgement);
generating a parameter function which indicates a functional relationship between the determined pulsation power parameters of the tissue pressure pulse curves and corresponding clamping pressures at the pressure cuff or measuring times (evaluation, observation, or judgement); and
determining at least one blood pressure value based on the parameter function (evaluation, observation, or judgement).
Independent claim 28 recites a measuring device configured to carry out process steps of claim 1, and differently recites:
A measuring device for the non-invasive determination of blood pressure values from a tissue pressure signal detected on an individual by means of a pressure cuff, the measuring device comprising at least one control unit which is configured to: [carry out the process of claim 1].
As indicated above, the independent claims recite at least one step or instruction grouped as a mental process. Therefore, each of the independent claims recites an abstract idea. Each limitation, aside from language reciting a generic computer components, can be grouped as a mental process (see italicized portions above), and is addressed as follows:
Each limitation identified via italics is merely a mental process of evaluation carried out on data gathered (tissue pressure signals) from a generically recited sensor (a pressure cuff).
No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
Alternatively or additionally, these steps describe the concept of using implicit mathematical formula(s) (i.e., evaluation of geometric features of pulse curves and generation and evaluation of parameter functions to determine blood pressure) to derive a conclusion based on input of medical data, which corresponds to concepts identified as abstract ideas by the courts, such as in Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989). The concept of the recited steps above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
Dependent claims 3 and 4 recite details related to details of the data gathered (i.e., that the tissue pressure signal is gathered over varying clamping pressures).
Dependent claims 5-15, 23, 26, and 27 recite limitations which are further evaluation steps of the abstract idea.
Dependent claim 31 recites constructional details of the data-gathering element, i.e., the pressure cuff.
Thus, the dependent claims merely include limitations that either further define the abstract idea (e.g., limitations relating to the extra-solution data gathered or particular steps which are entirely embodied in the mental process) and amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data (Int. Ventures v. Cap One Financial), collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group), collection, storage, and recognition of data (Smart Systems Innovations).
Step 2A, Prong 2
The above-identified abstract idea is not integrated into a practical application 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:
Independent claim 1 recites the additional element of a pressure cuff.
Independent claim 28 differently recites the additional element of a control unit.
Such additional elements are generically recited and do not improve the functioning of a computer or any other technology or technical field.
The claim recites merely acquiring data from a generically recited pressure cuff, having no operative connection to the abstract idea besides (as best understood) communication of obtained data, which amounts to insignificant, extra-solution activity in the form of mere data gathering, which does not constitute an integration into a practical application. Although the sensors may imply particular structure, their use in the mental process is merely extra-solution. See MPEP 2106.05(b).III:
“Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted)”
The control unit is recited at a high-level of generality (i.e., as a generic processors and memory performing a generic computer function of performing calculations and storing data, respectively) such that it amounts no more than mere instructions to apply the exception using a generic computer component.
Thus, such additional elements do not 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 generically recited 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 is not integrated into a practical application.
Moreover, the above-identified abstract idea of claim 28 is not integrated into a practical application under because the claimed method and device merely implements the above-identified abstract idea using rules (e.g., computer instructions), which are executed by a computer (e.g., control unit as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements in the case of claim 28 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. Applicant is reminded that abstract ideas cannot provide a practical application or significantly more (e.g., an improvement). Both Step 2A Prong 2 and Step 2B require an additional element, not an abstract idea, to provide a practical application or significantly more (e.g., an improvement). See Genetic Technologies Limited v. Merial LLC (Fed Cir 2016). Here, the additional elements of claims 1 and 28 are merely generically recited sensors or computer elements used as tools for executing the abstract ideas or insignificant extra-solution activity.
Dependent claims 3 and 4 recite an additional element pertaining to how the data is gathered, which is directed to mere extra-solution activity.
Dependent claims 5-15, 23, 26, and 27 do not recite any additional limitations aside from limitations of the abstract idea.
Dependent claim 31 “wherein the pressure cuff is formed as a shell wrap cuff comprising an inner kink-resistant shell,” which recites a constructional detail of the data-gathering element, which is a token addition to the claim. The use of the cuff still contributes nominally or insignificantly to the execution of the claimed process.
Thus, for these additional reasons, the abstract ideas identified above in the independent claims (and their respective dependent claims) are not integrated into a practical application.
Accordingly, the claims are each directed to an abstract idea.
Step 2B
None of the claims include additional elements that, when viewed as a whole, are sufficient to amount to significantly more than the abstract idea for at least the following reasons:
Independent claim 1 recites the additional element of a pressure cuff.
Independent claim 28 differently recites the additional element of a control unit which merely performs determination from signals obtained “by means of a pressure cuff.”
The control unit is generically claimed, and, without further constructional details of the device comprising the control unit, encompasses a general purpose computer performing the processes claimed. Thus, the control unit is reasonably construed as a generic computing device.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the control unit carrying out the processes recited, and merely recites that the control unit is “adapted to carry out the methods” recited in the independent claims. 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. 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 machine learning arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the control unit because it describes such an additional element in a manner that indicates that a control unit is 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).
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 and merely utilize already available computers with their already available basic functions to use as tools in executing the claimed process.
Dependent claims 3 and 4 recite an additional element pertaining to how the data is gathered, which is directed to mere extra-solution activity. The concept of operating a cuff from pressures ranging from a pressure below diastolic pressure to a pressure above systolic pressure is known from at least:
Pearce et al. (US 4625277 A) – Col. 1, lines 29-46, particularly: “In one well-known application of the oscillometric technique, the cuff is first inflated to a pressure above the patient's expected systolic pressure, and then slowly deflated over a pressure range inclusive of the patient's systolic and diastolic pressures.”
Ramsey III (US 4360029 A) – Col. 2, lines 7-30: gradual application of pressure over a range encompassing diastolic and systolic pressures.
Dependent claims 5-15, 23, 26, and 27 do not recite any additional limitations aside from limitations of the abstract idea. Examiner notes that the dependent claims recite limitations which are extra-solution or part of the abstract idea itself do not constitute significantly more. See MPEP 2106.05(a):
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
Dependent claim 31 “wherein the pressure cuff is formed as a shell wrap cuff comprising an inner kink-resistant shell,” which recites a constructional detail of the data-gathering element, which is a token addition to the claim. Such a structural is encompassed by blood pressure cuffs comprising what is known as a “curler,” which is considered a well-understood, routine, and conventional element as discussed by Jacober and Souma:
Jacober et al. (US 20190049977 A1) – Paragraphs 0001-0005: describing wrist-mounted blood pressure monitors, whereby a known attempt to solve the problem of transmitting adequate pressure is to include a curler. A curler is interpreted as encompassing “an inner kink-resistant shell.”
Souma et al. (US 20100106031 A1) – Paragraph 0080: “Conventionally, a damper formed by a stacked rigid plate member with large rigidity and foamed urethane is installed instead of the interrupting device 105.”
The recitation of the above-identified additional limitations in the claims amount 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 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.
For at least the above reasons, the claims are directed to applying an abstract idea 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. In other words, none of the claims provide 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 the independent claims do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment (processing of pressure cuff data). 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 instruct the practitioner to 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. As such, the above-identified additional elements, when viewed as whole, 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, the claims merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself, or (ii) provide a technical solution to a problem in a technical field.
Therefore, none of the claims amounts to significantly more than the abstract idea itself.
Accordingly, the claims are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 4, 6-12, 14, and 26-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelson et al. (US 4889133 A) (disclosed by Applicant) (hereinafter – Nelson).
Re. Claims 1 and 28: Nelson teaches a method for non-invasively determining at least one blood pressure value from a tissue pressure signal using a pressure cuff applied to an individual, the tissue pressure signal having a sequence of tissue pressure pulse curves (Abstract),
comprising:
identifying at least two individual tissue pressure pulse curves in the tissue pressure signal (Figs. 10a, 12a; Col. 6, lines 27-28: “Each signal is sent to filter 28 in order to have the cuff counterpressure component filtered out. The signal output of filter 28 corresponds to pressure pulsations”);
determining at least one amplitude parameter (Col. 5, lines 17-20: “… the present invention looks for a waveforms area, at least, as will be explained, up to the point that the waveform reaches a maximum amplitude;” Examiner notes that identifying a maximum amplitude is considered an amplitude parameter) and
one area parameter for each identified tissue pressure pulse curve (see previous citation – determination of a waveform’s area based on maximum amplitude),
the amplitude parameter indicating the amplitude of the identified tissue pressure pulse curve (see previous citation – a maximum amplitude, i.e., an amplitude parameter, is indicative of an amplitude of the pressure pulse curve (i.e., pulse waveform)) and
the area parameter indicating at least one partial area enclosed by the tissue pressure pulse curve (Fig. 3: see area 1 and area 2);
for each identified tissue pressure pulse curve,
determining a pulsation power parameter indicating a shape of the tissue pressure pulse curve based on at least the amplitude parameter and the area parameter (Fig. 4: waveform-specific area data curve);
generating a parameter function which indicates a functional relationship between the determined pulsation power parameters of the tissue pressure pulse curves and corresponding clamping pressures at the pressure cuff or measuring times (see previous citation – a functional relationship is established between waveform-specific area data and corresponding cuff counter pressures); and
determining at least one blood pressure value based on the parameter function (Fig. 8D: see determination of systolic, MAP, and diastolic pressure along waveform-specific area data curve, i.e., the parameter function).
Claim 28 recites limitations of claim 1 mutatis mutandis in a device claim and is rejected analogously. Examiner notes that the method of Nelson is also carried out via a control unit (Abstract).
Re. Claim 3: Nelson teaches the invention according to claim 1. Nelson further teaches the invention wherein the tissue pressure signal is determined over a pressure range of the pressure cuff starting from a low clamping pressure to a high clamping pressure and/or from a high clamping pressure to a low clamping pressure or a section thereof (Col. 5, lines 64-68: “To begin a blood-pressure measuring cycle, a pump 20 inflates cuff 14 to a point where it exerts a counterpressure against the arm that is above systolic pressure, thereby occluding vessel 16;” Fig. 8A; Col. 6, lines 1-5: “Under the control of a microprocessor (still to be discussed), a valve 22 progressively reduces the cuff counterpressure from the beginning counterpressure level above systolic pressure to an ending counterpressure to be described later”).
Re. Claim 4: Nelson teaches the invention according to claim 3. Nelson further teaches the invention wherein the low clamping pressure is below the diastolic blood pressure value and the high clamping pressure is above the systolic blood pressure value (Col. 5, lines 64-68: “To begin a blood-pressure measuring cycle, a pump 20 inflates cuff 14 to a point where it exerts a counterpressure against the arm that is above systolic pressure, thereby occluding vessel 16;” Examiner notes that “beginning to inflate; Fig. 8D: measured cuff counterpressure levels begin at point below diastolic pressure).
Re. Claim 6: Nelson teaches the invention according to claim 1. Nelson further teaches the invention wherein for each tissue pressure pulse curve the pulsation power parameter is obtained by linking at least one of a potentiated area parameter and a triple potentiated amplitude parameter (as best understood, Nelson teaches the pulsation power parameter is obtained by linking at least one of an area parameter and an amplitude parameter: Col. 5, lines 17-20: “… the present invention looks for a waveforms area, at least, as will be explained, up to the point that the waveform reaches a maximum amplitude;” Examiner notes that identification of an area based on a maximum amplitude links the area parameter and amplitude parameter).
Re. Claim 3: Nelson teaches the invention according to claim 1. Nelson further teaches the invention wherein the area parameter determined for each tissue pressure pulse curve indicates a partial area which is enclosed by the tissue pressure pulse curve and a straight line, horizontally, intersecting the tissue pressure pulse curve at a predetermined percentage amplitude value (Fig. 3).
Re. Claim 8: Nelson teaches the invention according to claim 1. Nelson further teaches the invention wherein the amplitude parameter determined for each tissue pressure pulse curve indicates at least one of
a difference between a tissue pressure diastolic minimum and a tissue pressure systolic maximum (Col. 6, lines 27-28: “Each signal is sent to filter 28 in order to have the cuff counterpressure component filtered out. The signal output of filter 28 corresponds to pressure pulsations;” Examiner notes that what remains is identified as a diastolic minimum and systolic maximum per each pulse)
and a difference between the pressure value at which the clamping pressure is zero and the tissue pressure systolic maximum.
Re. Claim 9: Nelson teaches the invention according to claim 1. Nelson further teaches the invention wherein the parameter function is generated by assigning to each pulsation power parameter for the corresponding tissue pressure pulse curve at least one of:
a measurement time and
a clamping pressure (Figs. 8A-8D: each waveform-specific area data point is assigned to a particular cuff counterpressure level).
Re. Claim 10: Nelson teaches the invention according to claim 1. Nelson further teaches the invention wherein a smoothing method or a curve fit is applied to the determined parameter function (Abstract: “A second artifact rejection technique is used, beginning at the second cuff-pressure step, to generate a prediction curve for predicting a next, expected-to-be-stored pulsation impulse value for a next, lower cuff-pressure step. The second artifact rejection technique is also used to repeatedly smooth the prediction curve based on the difference between a pulsation's calculated impulse value and its respective predicted impulse value. A final, smoothed curve is generated reflecting a final impulse value for each cuff-pressure step. From the final curve, the desired blood pressure parameters are derived and displayed in the form of Arabic numerals by means of an LCD readout;” Claim 17: “… computing an average waveform-specific area value from such chosen values; thereafter, from such average values, fitting a curve and, from such curve, predicting an expected-to-be-stored waveform-specific area-data value for a next baseline counterpressure step…”).
Re. Claim 11: Nelson teaches the invention according to claim 1. Nelson further teaches the invention wherein a first systolic blood pressure value is determined based on the parameter function by:
determining a maximum parameter function value of the parameter function (Fig. 8D: maximum of waveform-specific area data curve is identified at “MAP”);
in case of a pressure curve from a low to a high clamping pressure, determining a first parameter function value following the maximum parameter function value and which has, with respect to the maximum parameter function value, a parameter function value reduced by a predetermined proportion and the corresponding first measuring time or the corresponding first clamping pressure;
in case of a pressure curve from a high to a low clamping pressure, determining a first parameter function value preceding the maximum parameter function value and which has, with respect to the maximum parameter function value, a parameter function value reduced by a predetermined proportion and the corresponding first measuring time or the corresponding first clamping pressure (Fig. 8D: systolic pressure can be considered a “first parameter function value” preceding the maximum parameter function value (i.e., “MAP”) after pressures applied shown in Fig. 8A from higher to lower pressure); and
determining a first systolic blood pressure value corresponding to the first measuring time or the first clamping pressure from the tissue pressure signal or a signal dependent thereon, preferably an upper envelope of the tissue pressure signal (Fig. 8D: systolic pressure).
Re. Claim 12: Nelson teaches the invention according to claim 1. Nelson further teaches the invention wherein an alternative first systolic blood pressure value is determined based on the parameter function:
determining a maximum parameter function value of the parameter function is determined (Nelson discloses an alternative prior art method which encompasses what is required in claim 12: Figs. 1, 2: determination of a maximum parameter function value is indicated at Amp2);
determining a pressure value corresponding to the clamping pressure at a time of the maximum parameter function value or a pressure value corresponding to an upper envelope of the tissue pressure signal at a time of the maximum parameter function value (Figs. 1, 2: Amp2 has corresponding cuff counterpressure level from which MAP value is obtained); and
applying at least one of
a factor to the pressure value corresponding to the clamping pressure and
a factor to the pressure value corresponding to the upper envelope
in order to determine an alternative first systolic blood pressure value
(Col. 5, lines 7-13: “Deriving, for example, MAP from the data shown in FIG. 2, MAP would be defined as the cuff counterpressure (13) where Amp.sub.2 occurred, because Amp.sub.2 turned out to be the largest-amplitude pulse data acquired and stored. Systolic and diastolic pressures would then be calculated based upon this selection for determining MAP;” Examiner notes that calculating systolic pressure based on MAP implies application of some factor via calculation).
Re. Claim 14: Nelson teaches the invention according to claim 1. Nelson further teaches the invention wherein a first diastolic blood pressure value is determined using the generated parameter function by:
determining a maximum parameter function value of the parameter function (Fig. 8D: maximum of waveform-specific area data curve is identified at “MAP”);
in case of a pressure curve from a low to a high clamping pressure, determining a third parameter function value preceding the maximum parameter function value and which has, with respect to the maximum parameter function value, a parameter function value reduced by a predetermined proportion and the corresponding third measuring time or the corresponding third clamping pressure;
in case of a pressure curve from a high to a low clamping pressure, determining a third parameter function value following the maximum parameter function value and which has, with respect to the maximum parameter function value, a parameter function value reduced by a predetermined proportion and the corresponding third measuring time or the corresponding third clamping pressure (Fig. 8D: diastolic pressure identified at lower value of waveform-specific area data curve following the maximum parameter function value (“MAP”)); and
determining a first diastolic blood pressure value corresponding to the third measuring time or the third clamping pressure from the tissue pressure signal or a signal dependent thereon, preferably the lower envelope of the tissue pressure signal (see above).
Re. Claim 26: Nelson teaches the invention according to claim 1. Nelson further teaches the invention wherein the step of identifying tissue pressure pulse curves further comprises:
extracting the tissue pressure pulse curves by subtracting or filtering at least one clamping pressure portion from the tissue pressure signal (Col. 6, lines 27-28: “Each signal is sent to filter 28 in order to have the cuff counterpressure component filtered out. The signal output of filter 28 corresponds to pressure pulsations”); and
identifying at least two successive tissue pressure pulse curves (Col. 6,lines 28-34: “From filter 28, the filtered signal component is fed to converter 30 from which there emerges a first stream of digitized data which corresponds to pressure pulsations. The presently preferred monitoring interval for transducer 24 is about 5.5-msec”).
Re. Claim 27: Nelson teaches the invention according to claim 1. Nelson further teaches the invention wherein a pressure range determined during use of the pressure cuff is passed through with at least one predetermined or adaptive time-dependent pressure change rate (Abstract: “Cuff pressure is raised to a level above the patient's systolic pressure, and progressively reduced in a stepwise fashion to an ending cuff pressure”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over:
Nelson et al. (US 4889133 A) (disclosed by Applicant) (hereinafter – Nelson) in view of
McEwen (US 4479494 A) (hereinafter – McEwen).
Re. Claim 31: Nelson teaches the invention according to claim 28, but does not teach wherein the pressure cuff is formed as a shell wrap cuff comprising an inner kink-resistant shell.
McEwen teaches analogous art in the technology of blood pressure cuffs (Abstract). McEwen further teaches the invention wherein the pressure cuff is formed as a shell wrap cuff comprising an inner kink-resistant shell (Fig. 7B: plastic liner placed inside cuff envelope).
It would have been obvious to one having skill in the art before the effective filing date to have modified Nelson to include a kink-resistant shell within the pressure cuff as taught by McEwen, the motivation being that doing so better directs the pressure exerted by the inflated bladder towards the patient’s limb (Col. 6, lines 26-29: “This is because the liner acts as a stiffener, tending to direct the pressure exerted by the inflated bladder inward to the patient's limb, rather than outward against the cuff envelope”).
Examiner’s Note
Claims 5, 13, 15, and 23 do not have an art rejection applied; however, claims 15 and 23 are rejected under 35 U.S.C. 112(b) and claims 5, 13, 15, and 23 are rejected under 35 U.S.C. 101.
The reasoning behind the lack of prior art rejections as applied is as follows:
Claim 5 requires an area parameter and amplitude parameter be “linked” (i.e., set in relation to each other, as interpreted in light of page 5 of Applicant’s Specification) by a multiplication of the amplitude parameter and the area parameter. The prior art of record does not teach such a calculation. What is typically performed is identification of an area under an oscillometric curve using a calculation involving amplitude.
Claim 13 requires determination of a mean blood pressure using the generated parameter function recited in claim 1 (derived from area parameters and amplitude parameters) by determining a second parameter function value preceding or following the maximum parameter function value, which has, with respect to the maximum parameter function value, a parameter function value reduced by a predetermined proportion and the corresponding second measuring time or the corresponding second clamping pressure. What is typically performed in the prior arts is identification of a maximum amplitude of an envelope formed from maximum amplitudes, areas under curves, differences of peaks and troughs, etc. of oscillometric pressure pulses, identification of a maximum value of the resulting amplitude and identifying MAP from the identified corresponding pressure.
Claim 15 requires a specific formula not discussed in the prior arts of record.
Claim 23 requires a specific calculation not discussed in the prior arts of record.
Conclusion
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/JUSTIN XU/Primary Examiner, Art Unit 3791