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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/21/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 21, 2025 was filed after the mailing date of the Request for Continued Examination on November 21, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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(s) 1 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tehan et al (“Non-invasive vascular assessment in the foot with diabetes: sensitivity and specificity of the ankle brachial index, toe brachial index and continuous wave Doppler for detecting peripheral arterial disease”) (“Tehan”) in view of Hodgkiss-Harlow et al (“Interpretation of arterial duplex testing of lower-extremity arteries and interventions”) (“Hodgkiss-Harlow”).
Regarding Claim 1, while Tehan teaches a method (p155, Abstract) comprising:
contacting one or more Doppler ultrasound blood flow sensors with a pedal arch (Abstract, p156, 2. Materials and methods, “CW Doppler tracings of pedal arteries were taken using the Parks Vascular Mini Lab 1050c, 8.2 Mhz continuous wave Doppler, Parks standard 10 cm inflatable cuff, and ERKA switch blood pressure gauge… CWD waveforms were analysed by a single researcher who assessed each waveform, blinded to the results of CFDU and pressure measurement. Loss of multi-phasic pattern in either the dorsalis pedis or posterior tibial arteries (i.e., bi-phasic or tri-phasic) demonstrated by low-resistance, slow systolic acceleration and no diastolic flow reversal were considered positive for PAD (Poe, 2012).” The CW Doppler ultrasound blood flow sensor was applied to either the dorsalis pedis or posterior tibial artery of the pedal arch, indicating a contacting of the pedal arch);
aligning the one or more Doppler ultrasound blood flow sensors with one or more respective blood vessels of the pedal arch such that each Doppler ultrasound blood flow sensor is aligned with a respective blood vessel of the pedal arch selected from a group consisting of a posterior tibial artery, an anterior tibial artery, a peroneal artery, a lateral tarsal artery, a dorsalis pedis artery, an arcuate artery, a deep plantar artery, a lateral plantar artery, and a medial plantar artery (Abstract, p156, 2. Materials and methods, “CW Doppler tracings of pedal arteries were taken using the Parks Vascular Mini Lab 1050c, 8.2 Mhz continuous wave Doppler, Parks standard 10 cm inflatable cuff, and ERKA switch blood pressure gauge… CWD waveforms were analysed by a single researcher who assessed each waveform, blinded to the results of CFDU and pressure measurement. Loss of multi-phasic pattern in either the dorsalis pedis or posterior tibial arteries (i.e., bi-phasic or tri-phasic) demonstrated by low-resistance, slow systolic acceleration and no diastolic flow reversal were considered positive for PAD (Poe, 2012).” The CW Doppler ultrasound blood flow sensor was applied to either the dorsalis pedis or posterior tibial artery of the pedal arch, indicating an alignment to the stated arteries by the ultrasound system);
processing Doppler signals received from the one or more Doppler ultrasound blood flow sensors to determine a blood flow acceleration respectively associated with each Doppler ultrasound blood flow sensor (Abstract, p156, 2. Materials and methods, “CWD waveforms were analysed by a single researcher who assessed each waveform, blinded to the results of CFDU and pressure measurement. Loss of multi-phasic pattern in either the dorsalis pedis or posterior tibial arteries (i.e., bi-phasic or tri-phasic) demonstrated by low-resistance, slow systolic acceleration and no diastolic flow reversal were considered positive for PAD (Poe, 2012).” Doppler signals are processed by a researcher who is searching for “low-resistance, slow systolic acceleration and no diastolic flow reversal”); and
for each blood vessel, processing the respective blood flow acceleration time to assess a blood flow pathology (Abstract, p156, 2. Materials and methods, searched parameters used to assess for peripheral arterial disease, Table 2, p159, 4. Discussion, continuous wave Doppler ultrasound showed the highest sensitivity and specificity when compared to other assessment methods),
Tehan fails to teach evaluating blood flow acceleration by blood flow acceleration time;
the assessment of the blood flow pathology being made based on the blood flow acceleration time in the absence of other measures.
However Hodgkiss-Harlow teaches ultrasound assessment of lower extremity arteries (p95, Abstract) where evaluated arteries include arteries of the feet (p95, Abstract) such as the tibial artery (p96, 2. Lower extremity duplex testing, Table 2) where blood flow acceleration is evaluated by blood flow acceleration time, damping increase in waveform appear as occlusion worsens, damping increase indicates an increased acceleration time, and monophasic changes in the waveform occur as damping occurs (p96-97, 2. Lower extremity duplex testing, “For interpretation of PAD severity, the duplex-acquired velocity spectra parameters of acceleration time, pulsatility index (PI), and maximum spectra velocity measured at PSV and end-diastole are used (Table 1). Changes in these waveform parameters allow detection of segmental, hemodynamic significant occlusive disease…The systolic acceleration time during systole can also be used to diagnose occlusive disease proximal to pulsed Doppler recording site. A normal value is ≤133 ms [4]. As the systolic acceleration time increases to >200 ms, spectra waveform develops a rounded upslope (termed tardus parvas) configuration due to the prolonged time to PSV.” Table 3).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the judgement of blood flow acceleration of Tehan be done by blood flow acceleration time as taught in Hodgkiss-Harlow as an understood parameter in the art that standardizes applications of the Continuous Wave Doppler assessment across patients. Furthermore, it would be obvious that the identification of peripheral arterial disease can be done solely by acceleration time as the disappearance of diastolic flow reversal occurs and increase in acceleration time both occur as an obstruction worsens, as taught by Hodgkiss-Harlow (Table 3). Therefore, the changes in acceleration time will inherently include this phenomenon.
Regarding Claim 6, Tehan and Hodgkiss-Harlow teach the method according to claim 1 further comprising, for each blood vessel, processing the respective blood flow acceleration time to assess occlusion, such that:
on condition the blood flow acceleration time is less than 133 milliseconds, identifying the blood vessel as being un-occluded (See Claim 1 Rejection); and
on condition the blood flow acceleration time is greater than 200 milliseconds, identifying the blood vessel as being occluded (See Claim 1 Rejection), their combined efforts fail to teach on condition the blood flow acceleration time is less than 100 milliseconds, identifying the blood vessel as being un-occluded; and
on condition the blood flow acceleration time is greater than 225 milliseconds, identifying the blood vessel as being occluded.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that a final determination constituting a normal acceleration time and an occlusion acceleration time can be optimally be found by routine experimentation [“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)].
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tehan in view of Hodgkiss-Harlow and further in view of Succi et al (US 2014/0330087) (“Succi”).
Regarding Claim 2, while Tehan and Hodgkiss-Harlow teach the method according to claim 1, their combined efforts fail to teach wherein the one or more Doppler ultrasound blood flow sensors are disposed in a pad, wherein the pad is placed on a technician's hand and engaged with the pedal arch during measurement.
However Succi teaches a blood flow sensing system (Abstract, [0027]) where a blood flow ultrasound sensor may be placed on a finger pad of a glove and engaged with a monitoring location ([0027] special mention is made of engaging with dorsalis pedis artery).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the probe of Tehan and Hodgkiss-Harlow as a glove as taught by Succi as this provides an easily adaptable sensing system in terms of sensor placement (based on finger length and flexibility).
Regarding Claim 3, while Tehan and Hodgkiss-Harlow teach the method according to claim 1 their combined efforts fail to teach wherein the one or more Doppler ultrasound blood flow sensors are provided as part of a glove, wherein the glove is worn on a technician's hand and engaged with the pedal arch during measurement.
However Succi teaches a blood flow sensing system (Abstract, [0027]) where a blood flow ultrasound sensor may be placed on a finger pad of a glove and engaged with a pedal arch during measurement ([0027]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the probe of Tehan and Hodgkiss-Harlow as a glove as taught by Succi as this provides an easily adaptable sensing system in terms of sensor placement (based on finger length and flexibility).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tehan in view of Hodgkiss-Harlow and further in view of Kessler et al (US 2014/0058267) (“Kessler”).
Regarding Claim 4, while Tehan and Hodgkiss-Harlow teach the method according to claim 1, their combined efforts fail to teach one or more Doppler ultrasound blood flow sensors are located in a non- weightbearing planar surface, and wherein a foot of the patient is rested on the non- weightbearing planar surface during measurement
However Kessler teaches a continuous doppler monitoring device for pedal arteries (Abstract, [0004]) wherein the Doppler ultrasound blood flow sensor comprises a non- weightbearing planar surface, and wherein a foot of the patient is rested on the non- weightbearing planar surface during measurement (Figs. 1-3, [0020], [0022] Doppler sensors has patient side that flat / planar applied to the surface of the foot by an adhesive and is thus non-weightbearing).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the probe of Tehan and Hodgkiss-Harlow to have the sensor comprise a non- weightbearing planar surface as taught by Kessler as a simple substitution of one form of a Doppler ultrasound probe for another to obtain predictable results of accurately assessed blood flow characteristics.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tehan in view of Hodgkiss-Harlow and further in view of Tejani (US 2017/0000519).
Regarding Claim 5, while Tehan and Hodgkiss-Harlow teach the method according to claim 1, further comprising, for each blood vessel, processing the respective blood flow acceleration time to assess occlusion, such that:
on condition the blood flow acceleration time is less than 133 milliseconds, identifying the blood vessel as being un-occluded (See Claim 1 Rejection); and
on condition the blood flow acceleration time is greater than 200 milliseconds, identifying the blood vessel as being occluded (See Claim 1 Rejection), their combined efforts fail to teach the method further comprising, for each blood vessel, processing the respective blood flow acceleration time to assess claudication, such that:
on condition the blood flow acceleration time is greater than 120 milliseconds and less than or equal to 180 milliseconds, identifying the blood vessel as being associated with mild claudication; and
on condition the blood flow acceleration time is greater than 180 milliseconds and less than or equal to 224 milliseconds, identifying the blood vessel as being associated with severe claudication.
However Tejani teaches an occlusion treatment apparatus (Abstract) and further teaches a condition of occlusion may be judged from a symptom claudication, where claudication trends with occlusion severity ([0002]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to make a determination of claudication from the worsening blood flow of Tehan and Hodgkiss-Harlow, with the given bounds 133 ms and 200 ms given by Hodgkiss-Harlow, as this provides a spectrum with which to judge patient condition progression. Furthermore, it would be obvious to find the acceleration time ranges that best correspond to the intermediate degrees of claudication as a matter of routine experimentation from the teachings of Mori ["[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)].
Examiner’s Note
The Information Disclosure Statement, filed November 21, 2025, has been fully considered by the Examiner.
The Request for Continued Examination filed November 21, 2025, was submitted without claim amendments and without new arguments with respect to the 35 USC 103 rejections. Thus, Examiner maintains the same 35 USC 103 rejections as filed in the Final Rejection dated July 10, 2025, for the reasons given above and in the Advisory Action dated October 21, 2025.
The rejection stands.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791