DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 9/29/2025 has been entered.
Claims 1, 4, 7-8, 10, 13, 15-16, 20, 23, 26-27, 29, 38-40, 43, and 47-51 remain pending and under prosecution.
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.
No elements have been interpreted under 112(f).
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, 4, 7-8, 10, 13, 15-16, 20, 23, 26-27, 29, 38-40, 43, and 47-51 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1, 40, and 43 recite(s) “analyses/analyzes the information sensed by the microphone and identifies/identifying micro- pulses as deflections in pressure with an amplitude of the order 0.05 mmHg in the information sensed by the microphone.”
Under the first of the two-prong inquiry of step 2A for evaluating 101, these limitations are considered a mental process because the “analyzing” and “identifying” function to identify the micro-pulse (which appellant has stated is an existing but previously “unknown” physiological phenomenon – “They merely applied known algorithms to a pressure signal to extract micro-pulses that no one ever knew existed and then used these measurements to accurately determine systolic and diastolic blood pressure” pg.12 of Brief; “The technique as a whole is new because the inventors identified for the first time the existence of micro-pulses in a cuff pressure signal. These micro-pulses have not been identified anywhere in the prior art and so no one has known to look for the signals” pg.14 bottom-15 of Brief; “The inventors recognized for the first time that the recited micro-pulses existed and appear as a clear signal in the cuff pressure data” pg.17 Brief), when given its broadest reasonable interpretation may be performed in the user’s mind or using pen and paper, i.e. the micro-pulse is identified by viewing the signals. This is explicitly confirmed by the Appeal Brief on pg.11, which explicitly states:
“When using an appropriate pressure sensor with a frequency response above 20 Hz, these micro- pulses can be detected manually as explicitly stated in second to third paragraph on page 15 of the specification as filed. One skilled in the art would have no difficulty manually detecting the micro- pulses, for example by viewing the signals shown in an oscilloscope. Thus, contrary to the implicit assumption expressed by the allegation in the Office Action, no computer program is required to analyze the pressure and variances at least above 20 Hz to identify the recited micro-pulses.”
Also see “Moreover, no specific algorithm is necessary to so identify and extract the micro-pulse, as such identification can be made manually” (pg. 14 of Brief).
Thus, the analysis for identification of the micro-pulse constitutes the abstract idea of a mental process that can be performed in the mind or using pen and paper.
Under the second of the two-prong inquiry of step 2A, this judicial exception is not integrated into a practical application because there are no limitations that indicate improvements to the functioning of a computer or to the technology/technical field; effecting a particular treatment or prophylaxis for a disease/condition; applying the judicial exception with a particular machine (the control unit and sensor are recited with such generality that they are not considered a particular machine); effecting a transformation or reduction of a particular article to a different state/thing; applying the judicial exception in a meaningful way beyond generally linking to a particular technological environment, i.e. blood pressure measurement. There are no limitations referring to any practical output or application in the claims.
It is noted that the crux of the invention is the identification of the micro-pulse itself for the blood pressure measurement, because the identification of the micro-pulse enables steps (i) and (ii) to be performed. Without the identification of the micro-pulse, the blood pressure cannot be measured as claimed. However, those limitations regarding how to determine blood pressure do not add to the concept of the identification of the micro-pulse itself.
Since the second of the two-prong inquiry of step 2A is not satisfied, the claim is then evaluated under step 2B.
Under step 2B for evaluating 101, the claim(s) does not include additional elements that are sufficient to amount to significantly more than the judicial exception. While the claims recite a computer to perform the identification of the micro-pulse, the computer is claimed with such a high level of generality that it does not constitute any specific machine or structure to perform the function. The computer is thus considered well-known, routine, and conventional and does not amount to significantly more.
Additionally, the recitation of a cuff, chamber, and pressure sensor in the form of a microphone and steps associated with use of said structures are well-known, routine, and conventional structures in the blood pressure measurement art and are merely components to perform the known data gathering steps. Therefore, these also do not add significantly more to the abstract idea.
Lastly, the other limitations on how to determine the systolic blood pressure and the diastolic blood pressure do not impose meaningful limits on the abstract idea because they do not add significantly more to the abstract idea of identifying the micro-pulses, as those steps are not related to the identifying of the micro-pulse itself. While the claim also defines the micro-pulse as “a deflection in pressure with an amplitude of the order 0.05 mmHg” and “the micro-pulses occurring due to opening of the subject’s blood vessels during each beat of the subject’s heart only when pressure in the cuff or chamber is below systolic blood pressure and above diastolic blood pressure, said micro-pulses occurring prior to Korotkoff sounds pressure,” these limitations do not enable identification of the micro-pulse as they merely describe a characteristic of the micro-pulse and when it naturally occurs in the body. The amplitude of the micro-pulse may be determined in the mind by viewing the amplitude of the signals or using pen and paper. Thus, it does not add significantly more to the abstract idea.
Claims 4, 7-8, 10, 13, 15-16, 20, 23, 26-27, 29, 38-39, and 48-51 do not provide any practical application of the above abstract idea and do not further add significantly more because they focus on the pressure sensor or add details that are not directly related to the identification of the micro-pulse itself. Claim 47 indicates the micro-pulse can be identified by an algorithm but does not explain said algorithm, and thus does not preclude the identifying of the micro-pulse as a mental concept per the independent claims.
Thus, the claims are directed to an abstract idea of identifying a micro-pulse without being significantly more.
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.
Claim 51 is 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 51 recites “the second pressure sensor” and dependency upon Claim 1, however, claim 1 does not recite a second pressure sensor. Since claim 51 is new and new claim 50 introduces a second pressure sensor, it is believed that Claim 51 means to cite dependency on Claim 50. However, clarification is requested.
“active” verb for apparatus claims
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 1, 4, 10, 39-40, 43, and 47-49 are rejected under 35 U.S.C. 103 as being unpatentable over Pfeiffer (US Pub No. 20100324428) in view of Fukushima (US Pat No. 4635645), Hill et al (US Pat No. 4493326), and Flaherty et al (CA 2258263).
In regard to Claims 1, 40, and 43, Pfeiffer discloses a blood pressure measurement system for detecting arterial opening and closing comprising:
a cuff or a chamber 20 which is attachable to an apparatus 25 selectively able to pressurize said cuff or chamber, best seen in Figure 3 – “A fluid can be fed to or removed from the pressure cuff 20 via this volume-regulating device 25” (0081-0084);
a pressure sensor 21 in fluid communication with the cuff or chamber, said pressure sensor able to sense cuff or chamber pressure and variances therein, best seen in Figure 1 and 3 (0081-0084);
a computer 10 configured to process information sensed by the pressure sensor and analyze the sensed pressure and identifies micro-pulses as deflections in pressure with an amplitude in the information sensed by the pressure sensor – micro-pulses are considered “pulsatile signals” found below systolic blood pressure and above diastolic blood pressure (0081),
the micro-pulses as defined necessarily occurring due to opening of the subject’s blood vessels during each beat of the subject’s heart only when pressure in the cuff or chamber is below systolic blood pressure and above diastolic blood pressure because applicant has stated that the micro-pulse is a known biological phenomenon and occurs as indicated – “At point D, pulsatile signals are again recorded for the first time and the level of the systolic pressure is thus confirmed. Thus, the systolic and the diastolic levels are ascertained. Should there still be doubts as to the diastolic level, it is possible to further release the volume in the cuff until the pulsatile signals can no longer be recorded--then the diastolic level would be definitively confirmed. Starting from point D, the volume in the cuff is now further released to a level between the systolic and diastolic levels--this is reached at point E. In this range, the amplitude of the pulsatile signals is at its highest and thus the pulsatile signals to be measured are best to be picked up” (0081);
determines systolic and diastolic blood pressure, i.e. the blood pressure measurement necessarily takes into account a naturally occurring phenomenon in nature of the micro-pulses, defined here as the pulsatile signals, when the cuff or chamber is pressurized and the pressure reading lies between systolic blood pressure and diastolic blood pressure, best seen in Figure 1 (0039, 0081-0084),
wherein, (i) the systolic blood pressure (Ps) is determined as a cuff or chamber pressure at which the micro-pulses are first detected (point D on Figure 1), and
the diastolic blood pressure (Pd) is determined as a cuff or chamber pressure at which the micro-pulses cease to be detected (point G on Figure 1), as the cuff or chamber pressure is smoothly or incrementally decreased from above systolic pressure (0081); or
(ii) the diastolic blood pressure (Pd) is determined as a cuff or chamber pressure at which the micro-pulses are first detected (point A on Figure 1), and
the systolic blood pressure (Ps) is determined as a cuff or chamber pressure at which the micro-pulses cease to be detected (point B), as the cuff or chamber pressure is incrementally or smoothly increased from below diastolic pressure (0081).
However, Pfeiffer does not expressly disclose 1) the pressure sensor is a microphone and can sense pressure and variances at least above 20 Hz, 2) the micro-pulses have an amplitude of the order of 0.05 mmHg, and 3) the micro-pulses occurred prior to the Korotkoff sounds.
It is noted that measurement of Pfeiffer does not use Korotkoff sounds but it is well known that Korotkoff sounds occur in conjunction with the determination of systolic and diastolic blood pressure such that they occur only when pressure in the cuff or chamber is below systolic blood pressure and above diastolic blood pressure – similarly to the micro-pulses defined above.
Fukushima teach that it is well-known in the art to more effectively identify the Korotkoff sounds using a sound sensor 1 in cuff 6 to identify pulsatile blood pressure variation pulse P at a time occurring before the Korotkoff sounds – “pressure variations based on a pulsatile blood pressure variation within a brachial artery occur from a period of time before [effect added] the time during which Korotkoff sounds occur to a period of time thereafter. These variations are determined clearly by amplifying variations in an output from the pressure sensor 7 by an amplifier 8 and converted into a digital pulse in a comparator 9. This pulse is a pulse pressure variation pulse P shown in FIGS. 4 and 5. This pulse pressure variation pulse P is introduced into the CPU 11 as a reference signal for use in detecting Korotkoff sounds” (Col.3: 66-Col.4: 12), which thus leads to a more accurate detection of the systolic and diastolic pressure. Figure 2 and 7 show the P signal used to produce an output signal (f), which is shown to occur prior to the Korotkoff sound wave (f) (Col.5; 38-62). Thus, Fukushima show that pressure variations based on a pulsatile blood pressure variation within a brachial artery occur from a period of time before the time during which Korotkoff sounds occur. These pressure variations are analogous to the micro-pulses or pulsatile signals monitored in Pfeiffer.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pfeiffer such that the micro-pulses occurred prior to the Korotkoff sounds as taught by Fukushima because that is the relative time for the micro-pulse, which can be found in Fukushima and already monitored by Pfeiffer, to occur relative to the naturally occurring Korotkoff sounds of Fukushima and as is well-known in the art. Additionally, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pfeiffer such that the Korotkoff sounds are taken into account using the sound sensor of Fukushima to effectively provide a reference for the pulsatile signals of Pfeiffer, since the pulsatile signals of Pfeiffer and Korotkoff sounds are interrelated in the measurement of systolic and diastolic blood pressure as is well-known and also disclosed by Fukushima.
Hill et al teach that it is well-known in the art to provide an analogous blood pressure measurement system that uses a microphone 40 within cuff 16 to sense the Korotkoff sounds in a manner similar to Fukushima and as well known in the art, best seen in Figure 1. Additionally, Hill et al teach the microphone can sense pressure and variances at least above 20 Hz – “the microphone 40 is preferably a commercially available contact microphone having a frequency response in the frequency range of 0.5 Hz to 150 Hz” (Col.7: 45-47).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pfeiffer as modified by Fukushima such that the pressure sensor is a microphone and can sense pressure and variances at least above 20 Hz as taught by Hill et al to effectively enable the Korotkoff sounds to be taken into account along with the micro-pulses of Pfeiffer, since the pulsatile signals of Pfeiffer and Korotkoff sounds are interrelated in the measurement of systolic and diastolic blood pressure as is well-known in the art and also disclosed by Fukushima.
Flaherty et al teach that it is well-known in the art to provide an analogous pressure sensor 76 to measure blood pressure with a sensitivity to measure pressure changes as small as 0.1 mmHG (pg. 27, line24-26).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pfeiffer such that the pressure sensor has a high sensitivity as suggested by Flaherty et al such that the micro-pulses of Pfeiffer can be measured as having an amplitude of the order of 0.05 mmHg, since Pfeiffer already discloses measuring the amplitude of the pulsatile signals – “the amplitude of the pulsatile signals is at its highest and thus to be detected most clearly” (0013), and such that a skilled artisan would be motivated to have the amplitude measured on the order of 0.05 mmHg, to optimize the device for accuracy of signal detection by having the pressure sensor to be an order of magnitude enabled to detect the pulsatile signals of Pfeiffer.
Claim 4: Pfeiffer disclose the pressure sensor is a single pressure sensor 21, best seen in Figure 3 (0083).
Claim 10: Pfeiffer disclose the single pressure sensor 21 is part of the cuff or chamber 20, or is in close proximity to, or is proximal to, the cuff or chamber 10, best seen in Figure 3 (0081-0084).
Claim 39: Pfeiffer disclose a blood pressure measurement system as in claim 1 wherein blood pressure readings are determined using time difference information, i.e. first reading and then second reading, best seen in Figure 1 (0081-0084).
Claim 47: Pfeiffer disclose the blood pressure measurement system of claim 1, wherein the micro-pulses are identified by a signal processing and a computer algorithm in computer 10 as illustrated in Figure 1 (0081-0084).
Claim 48: Hill et al disclose the blood pressure measurement system of claim 1, wherein the microphone 40 is incorporated into a wall of the cuff 16 or chamber – “a microphone 40 is disposed within the cuff 16 so that when the cuff is placed about the arm, the microphone rests against the skin in close proximity to the brachial artery” (Col.5: 13-16).
Claim 49: Pfeiffer in combination with Fukushima disclose the blood pressure measurement system of claim 1, wherein the Korotkoff sounds are associated with starting and stopping of blood flow in the subject’s blood vessels as the subject’s blood pressure rises above and falls below the pressure in the cuff or chamber, as is well-known in the art as well as disclosed by Fukushima (Col.3: 66-Col.4: 12).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Pfeiffer in view Fukushima, Hill et al, and Flaherty et al, further in view of Beach et al (US Pub No. 20060079782).
Pfeiffer et al in combination with Fukushima, Hill et al, and Flaherty et al disclose the invention above but do not expressly disclose said single pressure sensor is able to sense cuff or chamber pressure, and variances therein at least up to 300 Hz. Beach et al teach that it is well-known in the art that diastolic pressure can reach at least up to 300 Hz (0185). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to have the pressure sensor of Pfeiffer et al as modified by Fukushima, Hill et al, and Flaherty et al to sense cuff or chamber pressure, and variances therein at least up to 300 Hz as taught by Beach et al to effectively enable an appropriate range of sensing for the blood pressure measurement.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Pfeiffer in view Fukushima, Hill et al, and Flaherty et al, further in view of Harada et al (US Pat No. 5759157).
Pfeiffer in combination with Fukushima, Hill et al, and Flaherty et al disclose the invention above but do not expressly disclose filtering. Harada et al teach that the reading from the single pressure sensor is filtered electronically to remove components below 20 Hz or 30 Hz using filters 20, 22 to effectively determine the systolic and diastolic blood pressure, best seen in Figure 1 (Col.4: 28-49). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pfeiffer as modified by Fukushima, Hill et al, and Flaherty et al such that the single pressure sensor is filtered electronically to remove components below 20 Hz or 30 Hz as taught by Harada et al to effectively determine the systolic and diastolic blood pressure as desired.
Claim 13, 15, 20, 23, 29, 38, and 50-51 are rejected under 35 U.S.C. 103 as being unpatentable over Pfeiffer in view Fukushima, Hill et al, and Flaherty et al, further in view of Blansett (US Pat No. 7153269).
In regard to Claim 13 and 50, Pfeiffer et al in combination with Fukushima, Hill et al, and Flaherty et al disclose the invention above but do not expressly disclose a first high frequency pressure sensor and a second low frequency pressure sensor. Hill et al teach that the pressure sensor in the form of a microphone used to modify Pfeiffer et al has a low as well as high frequency range – “the microphone 40 is preferably a commercially available contact microphone having a frequency response in the frequency range of 0.5 Hz to 150 Hz” (Col.7: 45-47).
Blansett teach that it is well-known in the art to provide two pressure sensors 26, 27 in analogous blood pressure measuring device to enable sensing of distinct pressures, best seen in Figure 1 and 6 (Col.3-Col.4: 3; Col.6: 37-Col.8: 10).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the invention of Pfeiffer et al as modified by Fukushima, Hill et al, and Flaherty et al to use two pressure sensors as taught by Blansett such that one is a first high frequency pressure sensor and a second low frequency pressure sensor as an equally as effective configuration for the measuring a low and high range of pressure for the blood pressure measurements in the desired frequency ranges for the determination of the systolic and diastolic pressures, the second pressure sensor configured to sense cuff or chamber pressure and variances at least equal to or below 2Hz as already taught by Hill et al, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose.").
Claim 15. Pfeiffer et al in combination with Hill et al and Blansett disclose the high frequency pressure sensor senses at least above 20 Hz, or above 30 Hz as taught by Hill et al (Col.7: 45-47).
Claim 20. Pfeiffer et al in combination with Hill et al and Blansett disclose the high frequency pressure sensor is part of the cuff or chamber, or is in close proximity to, or is proximal to, the cuff or chamber, best seen in Figure 3 of Pfeiffer or Figure 1 of Hill et al.
Claim 23. Pfeiffer et al in combination with Hill et al and Blansett disclose the low frequency pressure sensor is able to sense cuff or chamber pressure and variances therein at least below 2 Hz as taught by Hill et al (Col.7: 45-47).
Claim 29. Pfeiffer et al in combination with Hill et al and Blansett disclose the low frequency pressure sensor is part of the cuff or chamber, or is in close proximity to, or is proximal to, the cuff or chamber, best seen in Figure 3 of Pfeiffer or Figure 1 of Hill et al.
In regard to Claim 38, Pfeiffer et al as modified disclose the invention above but do not expressly disclose a segment of high frequency cuff or chamber pressure change, which is defined from a fixed timing window referenced to its corresponding foot of a low frequency oscillometric pulse, is further processed using a low pass filter and the original segment is then replaced by a filtered segment. Blansett teach that it is well-known in the art to use a low pass filter to remove noise from a pressure measurement and the original segment is then replaced by a filtered segment to reduce the effect of the noise (Col.6: 37-64).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pfeiffer et al as modified by Fukushima, Hill et al, and Flaherty et al such that a segment of high frequency cuff or chamber pressure change, which is necessarily defined from a fixed timing window referenced to its corresponding foot of a low frequency oscillometric pulse, since this is the nature of blood pressure, is further processed using a low pass filter and the original segment is then replaced by a filtered segment as taught by Blansett to effectively reduce the noise in the high frequency cuff pressure change.
Claim 51: Pfeiffer in combination with Hill et al and Blansett disclose the computer 10 of Pfeiffer is configured to process information sensed by the second pressure sensor and analyze the pressure and variances therein at least equal to or below 2Hz (as taught by Hill et al) measured by the second pressure sensor to produce an oscillometric waveform having a rising pressure component and a descending pressure component corresponding to each beat of the subject’s heart, the oscillometric waveform shown in Figure 1 of Pfeiffer.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Pfeiffer in view of Fukushima, Hill et al, Flaherty et al, and Blansett, further in view of Beach et al.
Pfeiffer et al in combination with Fukushima, Hill et al, Flaherty et al, and Blansett disclose the invention above but do not expressly disclose said pressure sensor is able to sense cuff or chamber pressure, and variances therein at least up to 300 Hz. Beach et al teach that it is well-known in the art that diastolic pressure can reach at least up to 300 Hz (0185). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to have the pressure sensor of Pfeiffer et al as modified by Fukushima, Hill et al, Flaherty et al, and Blansett sense cuff or chamber pressure, and variances therein at least up to 300 Hz as taught by Beach et al to effectively enable an appropriate range of sensing for the blood pressure measurement.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Pfeiffer in view of Fukushima, Hill et al, Flaherty et al, and Blansett, further in view of Norris (US Pat No. 7403806).
Pfeiffer et al in combination with Fukushima, Hill et al, Flaherty et al, and Blansett disclose the invention above including a classic band-pass analogue/digital filter 3, 17 in Figure 1 and 3A of Fukushima, but do not disclose the filtered signal is enhanced by the multiplication of a transfer function, reducing signals with low amplitude and enhancing the signals with large amplitude. It is noted that applicant does not disclose said effect of reducing low amplitude and enhancing large amplitude as providing a specific advantage, conferring a desired result, or providing any criticality other than what is routine and conventional in terms of filtering biological data. Norris teach that it is well-known in the art to use a transfer function for multiplication on analogous biological signals which would thus affect its amplitude in a desired fashion (Claim 17-18, Col.8: 18-51). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the invention of Pfeiffer et al as modified by Fukushima, Hill et al, Flaherty et al, and Blansett such that there is included multiplication by a transfer function as taught by Norris to the signal filtered by the band-pass filter of Fukushima such that a desired effect of reducing signals with low amplitude and enhancing the signals with large amplitude results as a desired result that is conventional and routine within the art.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Pfeiffer in view Fukushima, Hill et al, Flaherty et al, and Blansett, further in view of Harada et al.
Pfeiffer in combination with Fukushima, Hill et al, Flaherty et al, and Blansett disclose the invention above but do not expressly disclose filtering. Harada et al teach that the reading from the single pressure sensor is filtered electronically to remove components below 20 Hz or 30 Hz using filters 20, 22 to effectively determine the systolic and diastolic blood pressure, best seen in Figure 1 (Col.4: 28-49). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Pfeiffer as modified by Fukushima, Hill et al, Flaherty et al, and Blansett such that the single pressure sensor is filtered electronically to remove components below 20 Hz or 30 Hz as taught by Harada et al to effectively determine the systolic and diastolic blood pressure as desired.
Response to Arguments
Applicant's arguments filed with respect to the 101 rejection have been fully considered but they are not persuasive. Despite applicant’s amendments including the addition of the microphone and language relating to details surrounding the micro-pulses, the claims recite the abstract idea of a mental process of analyzing and identifying micro-pulses without being significantly more. Please see the details above.
The previous 112 rejections are withdrawn in light of the PTAB decision dated 7/30/2025.
In light of the art rejection set forth, it is noted that aside from the timing of the pulsatile signals of Pfeiffer, applicant has not provided any reasons why said pulsatile signals do not constitute micro-pulses. Fukushima, Hill et al, and Flaherty et al have been set forth to teach the new limitations as elaborated above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Huong Q NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached on 5712723672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791