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 .
Examiner’s Notes and Response to Arguments
In the final Office action dated July 15, 2025, it is noted that the priority date of the instant Application is set to be January 18, 2017 in view of the claim amendment filed on June 20, 2025. Because of this, the previously cited reference Howard should no longer be qualitied as a prior art as it post-dates the priority date of the instant Application. Examiner, however, has (1) omitted the deletion of the Howard art from the heading of the rejection under 35 U.S.C. 103 to claims 21, 24, 25, 27, 30, 33, 38-41, 43 and 45; and (2) mistakenly noted in the rejection to claim 31 that the citation ([0016]) belongs to Howard. In regard to the above two issues: (1) though Howard is listed in the heading of the rejection to claims 21, 24, 25, 27, 30, 33, 38-41, 43 and 45, Howard is not relied upon in the rejection body; and (2) the citation [0016] in the rejection of claim 31 is from Stergiou. Howard was never relied upon for the teaching to reject claim 31.
As a consequence, a second final Office action is now issued to correct the above informality issues. The rejections under 35 U.S.C. 103 to all the pending claims are maintained and corrected such that Howard is no longer listed or cited in this Office action.
In specific, the rejections under 35 U.S.C. 103 to all the pending claims except for claim 31 are maintained but the heading of the rejection is now corrected; and the rejection under 35 U.S.C. 103 to claim 31 is now withdrawn after reconsideration. A new ground of rejection is now made.
DETAILED ACTION
Claims 21, 24-27, 30-34, 36 and 38-46 are pending and under examination in this Office action.
Priority
The previous consideration in regard to Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is now withdrawn in view of the claim amendment. Applicant is now considered entitled for the benefit of an earlier filing date under 35 U.S.C of January 18, 2017.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claims 21 and 24: Claim limitations “an ultrasound element configured to transmit ultrasound”, and “an optical element configured to transmit an optical signal” have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “element” coupled with functional language “to transmit” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “element”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Claims 21 and 24: “an ultrasound element” and “an optical element” refer to the specification, PG Pub US 2024/0206746 A1, [0039]: vital signs monitor further includes an ultrasound transducer…The transducer includes an active element is made of piezoelectric material or micromachined ultrasonic transducer or other MEMs devices; and [0070]: an optical sensor,…a second sensor…such as a light emitting diode or the like; and .
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
Claims 21, 24, 25, 27, 30-31, 33, 38-41, 43 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Habu et al., US 6,176,832 B1, hereinafter Habu, in view of Stergiou et al., US 2015/0073230 A1, hereinafter Stergiou.
Claims 21, 24, 30, 33, 38. Habu teaches in FIGS.1&2 a vital sign monitor, a medical device, and a method comprising:
a display screen (Col.8, ll.54-56: the calculated blood pressure value can be output to a display device such as a blood pressure display liquid crystal monitor);
an ultrasound element (4a&4b) configured to transmit ultrasound toward a blood vessel (2) of a subject and to detect a reflection of the ultrasound from the blood vessel (Col.4, ll.13-23: FIG.2, the ultrasonic transducer group 4a comprises n ultrasonic transducers a1 to an…the ultrasonic transducer a1 of the ultrasonic transducer group 4a emits an ultrasound wave toward an artery 2 and detects a signal obtained upon reflecting the emitted ultrasonic wave by the arterial wall. This series of operations are repeated from the vibrator a1 to the vibrator an to obtain an ultrasonic tomogram 3a. After the arterial tomogram 3a is obtained, an arterial tomogram 3b is obtained by the same operation as in the operation of obtaining the arterial tomogram 3a); and
a processor (FIG.1: 5-10; and FIG.3: 11a and 11b) configured to:
determine a pulse wave velocity of the blood vessel by analyzing the signal (Col.3, ll.51-55: the pulse wave velocity detection unit 7 calculates a pulse wave propagation velocity; Col.8, ll.24-30: The pulse wave velocity calculation unit 7 divides the distance between points A and B by a time delay t (phase difference) of a time change in cross-sectional areas between points A and B, thereby calculating the pulse wave velocity C0 as follows C0=L/t);
determine a blood velocity of blood flowing in the blood vessel by analyzing the reflection of the ultrasound from blood flowing in the blood vessel (Col.3, ll.51-55: the blood flow velocity calculation unit 6 calculates a blood flow velocity from the cross-sectional areas and the distance between the two points; and Col.8, ll.41-44 that the above processing allows the blood pressure calculation unit 10 to continuously calculate the blood pressure on the basis of the blood pressure values at time phases measured by the reference pressure measurement unit 9);
determine a blood pressure of the subject by multiplying the pulse wave velocity of the blood vessel with the blood velocity of the blood flowing in the blood vessel (Col.3, line 57 to Col.4, line 7: The blood flow velocity calculated by the blood flow velocity calculation unit 6 and the pulse wave velocity calculated by the pulse wave velocity calculation unit 7 are transmitted and substituted in the following conversion equation: P-P0=rC0v+(1/8)rv2…by the above equation, the relative value to the minimum blood pressure as the reference value is calculated and output to a blood pressure change calculation unit 8 – C0 is the telediastolic pulse wave propagation velocity and v is the flow velocity averaged over cross-section of the blood vessel); and
output an indication of the blood pressure of the subject via the display screen (Col.8, ll.54-56: the calculated blood pressure value can be output to a display device such as a blood pressure display liquid crystal monitor).
Habu teaches two sensing elements being two ultrasound elements, with which the pulse wave velocity of the blood vessel is determined by analyzing the signal data acquired by the two ultrasound elements from the wall of the blood vessel. Habu does not teach one of the sensing elements is an optical element, i.e., Habu does not teach that the pulse wave velocity is determined by analyzing the optical signal that is detected by an optical element.
However, in an analogous PWV-based blood pressure determination field of endeavor, Stergiou teaches in FIG.2 and [0032]: a mobile device that includes a processing device 202, an audio sensor 204, and an optical sensor 206.
Stergiou further teaches
an optical element configured to transmit an optical signal toward the blood vessel of the subject and to detect the optical signal from a wall of the blood vessel ([0059]: At block 504, an optical data signal may be generated representing blood volume within a blood vessel of the subject over time. The optical data signal may be generated by the optical sensor 206 of the device 102 for FIG.2, for example. Generating the optical data signal representing blood volume within the blood vessel of the subject over time may include using a camera integrated in a smartphone and against which the subject has positioned a finger as a photoplethysmography to generate an electrical signal representing light absorption of the finger over time, where the electrical signal is the optical data signal); the processor configured to
determine a pulse wave velocity of the blood vessel by analyzing the optical signal ([0048]: FIG.4: the calculation of PWTT based on an audio data signal 402 and an optical data signal 404; [0051]: a time delay, e.g., an elapsed time, may then be calculated between each S1 peak in the audio data signal 402 and the corresponding blood volume peak in the optical data signal 404…Each of the time delays…are examples of instantaneous PWTTs; [0052]: in the equation, PWV is calculated from PWTT; and [0053]: in the Moen-Korteweg equation, PWV is pulse wave velocity, PWTT is the pulse wave transit time as already mentioned).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the monitor, device or method of Habu to substitute one of the ultrasound element with an optical element for determining a pulse wave velocity as taught in Stergiou. Such a substitution with Stergiou provides one of the conventionally recognized means for determining a pulse wave velocity other than using two ultrasound elements as taught in Habu.
Claims 25 and 39. Habu further teaches that
the output device comprises a display screen or a speaker (Col.8, ll.54-56: the calculated blood pressure value can be output to a display device such as a blood pressure display liquid crystal monitor, a recording memory medium, a printer, or the like).
Claim 27. Stergiou further teaches that
the ultrasound element comprises an array of piezoelectric elements ([0035]: the audio sensor 204 may include…a piezoelectric transducer).
Claim 31. Stergiou further teaches that the device further comprises
electrocardiogram (ECG) electrodes coupled to the ultrasound element and the optical element ([0016]: components external to such smartphones, such as an ECG chest strap and/or an ECG patch, may be provided to obtain an electrocardiogram so that PWTT may be calculated based on the simulated PPG measurements and the electrocardiogram) – an ECG electrocardiogram is measured via ECG electrodes.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the device of Habu and Stergiou combined employ the feature of further comprising ECG electrodes as taught in Howard for the advantage of “so that PWTT may be calculated based on the simulated PPG measurements and the electrocardiogram”, as suggested in Stergiou, [0016].
Claim 40. Habu further teaches
transmitting data comprising an indication of the blood pressure of the subject (Col.8, ll.54-56: the calculated blood pressure value can be output to a display device such as a blood pressure display liquid crystal monitor, a recording memory medium, a printer, or the like).
Claims 41, 43 and 45. Habu further teaches
Determining the blood velocity of the blood flow in the blood vessel by determining a phase change of the reflection of the ultrasound from the blood flowing in the blood vessel (claim 6: pulse wave measurement means for measuring a pulse wave propagation velocity in accordance with a phase difference of changes in sectional shapes of a plurality of arterial walls which are obtained by said plurality of ultrasonic detection means; and Col.3, ll.51-55: the blood flow velocity calculation unit 6 calculates a blood flow velocity from the cross-sectional areas and the distance between the two points; and Col.8, ll.41-44 that the above processing allows the blood pressure calculation unit 10 to continuously calculate the blood pressure on the basis of the blood pressure values at time phases measured by the reference pressure measurement unit 9).
Claims 26, 34, 42, 44 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Habu et al., US 6,176,832 B1, hereinafter Habu, in view of Stergiou et al., US 2015/0073230 A1, hereinafter Stergiou, further in view of Sawado et al., US 2017/0251936 A1, hereinafter Sawado.
Claims 26 and 34. Habu as modified does not teach that the optical element comprises a light emitting diode (LED).
However, in an analogous optical sensor-based PWV measurement field of endeavor, Sawado teaches that
the optical element comprises a light emitting diode (LED) ([0080]: the biological information measurement apparatus measures biological information regarding the subject using light emitting diode (LED) beams).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the medical device of Habu as modified employ such a feature of the optical element comprises a LED as taught in Sawado for the advantage of providing a conventionally-used type of optical element for optical signal sensing.
Claims 42, 44 and 46. Habu as modified does not teach that the vital signa monitor or the medical device is a wearable device.
However, in an analogous optical sensor-based PWV measurement field of endeavor, Sawado teaches that
the vital signa monitor or the medical device is a wearable device ([0036]: FIG.1, the biological information measurement apparatus 1 is a wrist-watch type wearable device which the subject wears on the wrist).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the medical device or the vital sign monitor of Habu as modified employ such a feature of being a wearable device in Sawado for the well-acknowledged advantage for a wearable biometric monitoring device of providing a continuous monitoring means that enables a long-term tracking as a daily routine.
Claims 32 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Habu et al., US 6,176,832 B1, hereinafter Habu, in view of Stergiou et al., US 2015/0073230 A1, hereinafter Stergiou, further in view of Kaufman et al., US 2017/0000688 A1, hereinafter Kaufman.
Claims 32 and 36. Habu further teaches that
the medical device is configured to be affixed to a neck, the blood vessel being disposed in the neck (Col.10, ll.25-28: the pulse wave velocity is generally obtained by the time difference between the carotid wave an the hip artery wave and reflect the degree of arteriosclerosis of all the arteries present between the carotid and the femoral artery).
The carotid artery is located in the neck of an individual. In order to measure the pulse wave velocity from the carotid artery, the device would be configured to be affixed to a neck. However, if Habu is considered not explicitly teaching that the medical device is configured to be affixed to a neck, in an analogous blood pressure measurement device field of endeavor, Kaufman teaches that
the medical device is configured to be affixed to a neck, the blood vessel being disposed in the neck ([0021]: the portion of the body surface of the patient selected for attaching the sensor that monitor a parameter indicative of a blood flow or pressure waveform…Example portions of the body surface of the patient that can be selected for attaching the sensors included the chest, the neck, the abdomen, the limb of the patient, etc).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the medical device of Habu as modified employ such a feature of being configured to be affixed to a neck as taught in Kaufman for the advantage of properly securing the medical device to the region of interest for monitoring a parameter indicative of a blood flow or pressure waveform responsive to CPR, as suggested in Kaufman, [0021].
Response to Arguments
Applicant’s arguments in regard to the claim interpretation under 35 U.S.C. 112(f) have been fully considered but they are not persuasive. Applicant asserted that claims 21, 24 and 33 have been amended such that the claims no longer invoke interpretation under 35 U.S.C. 112(f). However, the claim limitations that invoke the interpretation under 35 U.S.C. 112(f), namely, “an ultrasound element configured to transmit ultrasound”, and “an optical element configured to transmit an optical signal” in claims 21 and 24 stay un amended. The claim interpretation for these limitation hence is maintained.
Applicant’s arguments in regard to the rejection under 35 U.S.C. 103 have been fully considered but they are not persuasive. In specific, Applicant asserted that Stergiou “does not teach or suggest any technique for converting PWTT into pulse wave velocity, hence Stergiou does not teach or suggest “determine a pulse wave velocity of the blood vessels by analyzing the optical signal”. Examiner respectfully disagrees and notes that, Stergiou teaches in [0052] an equation that calculates PWV from PWTT, and in [0053] it further explicitly teaches that “in the Moens-Korteweg equation, PWV is pulse wave velocity (i.e., “velocity” as asserted in the Remarks, p.8, line 7) and PWTT is the pulse wave transit time (i.e., “a time interval” as asserted in the Remarks, p.8, line 6).
In addition, Habu teaches the newly added claims 41, 43 and 45 in regard to the feature associated with the phase change of the ultrasound reflection. Further, the previously cited Sawado teaches the newly added claims 42, 44 and 46.
Based on the above considerations, the pending claims 21, 24-27, 30-34, 36 and 38-46 remain rejected.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798