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 .
Applicant’s arguments filed in the reply on April 30, 2026 were received and fully considered. Claims 1-3 were amended. Please see below for more detail.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/30/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 19, 2026 was filed after the mailing date of the Request for Continued Examination on April 30, 2026. 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 Arkans (US 6,358,219) in view of Hodgkiss-Harlow et al ("Interpretation of arterial duplex testing of lower-extremity arteries and interventions") ("Hodgkiss-Harlow").
Regarding Claim 1, while Arkans teaches a method (Abstract) comprising:
contacting one or more Doppler ultrasound blood flow sensors with a skin surface (Abstract, Col. 3, L. 5-19, “This allows assessment of the health of the skin tissue by looking at the color and texture of the skin. Skin blood flow can also be assessed by applying sensors such as a laser Doppler flux probe or a photo plethysmographic probe. Finally, an underlying artery can be palpated for pulsatility by hand or by using an electric monitor incorporating a strain sensitive element or continuous wave ultrasonic Doppler probe that is placed on the skin over the artery.” An ultrasonic Doppler probe is placed in contact with skin surface over the artery, Col. 3, L. 20-33, where the artery being measured is the dorsalis pedis artery at the midtarsal region);
aligning the one or more Doppler ultrasound blood flow sensors with one or more respective blood vessels of a pedal arch such that each Doppler ultrasound blood flow sensor is aligned with a respective blood vessel of the pedal arch (Abstract, Col. 3, L. 5-33, “Finally, an underlying artery can be palpated for pulsatility by hand or by using an electric monitor incorporating a strain sensitive element or continuous wave ultrasonic Doppler probe that is placed on the skin over the artery.” Indicating the ultrasonic Doppler blood flow sensor is aligned with a blood vessel in the monitoring region of a pedal arch);
processing Doppler signals received from the one or more Doppler ultrasound blood flow sensors to determine a blood flow associated with each Doppler ultrasound blood flow sensor (Col. 9, L. 6 – Col. 10, L. 5, Doppler probes are used to evaluate blood flow and the effectiveness of treatments related to blood flow); and
Arkans further teaches that is known in the art that blood flow acceleration is related to patient health and pathology (Col. 2, L. 27-45, treatments for blood flow related conditions involve modulating blood flow acceleration).
Examiner will note here that the reference of Tehan from the previous action was removed was also measuring blood flow at the dorsal pedis artery. However, Examiner reads the claims amendments as changing the scope from stating that the entirety of the dorsal pedis artery is necessarily part of the pedal arch to now stating that only the blood vessels present in the pedal arch read on the claim. Examiner considers Arkans as reading on this claim language as the measured area of the dorsal pedis artery between regions A and B in Arkans is shown to be limited to the pedal arch area.
Arkans fails to teach processing Doppler signals received from the one or more Doppler ultrasound blood flow sensors to determine a blood flow acceleration time respectively associated with each Doppler ultrasound blood flow sensor; and
for each blood vessel, processing the respective blood flow acceleration time to assess a blood flow pathology,
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 of Arkans to be performed by blood flow acceleration time as taught in Hodgkiss-Harlow as this provides a standardized metric with which to consider blood flow in Arkans. This simplifies the creation of thresholds, identification of improvements, and judgement of patient-specific changes in the blood flow. 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, Arkans 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 Arkans in view of Hodgkiss-Harlow and further in view of Succi et al (US 2014/0330087) (“Succi”).
Regarding Claim 2, while Arkans 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 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 Arkans 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 Arkans 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 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 Arkans 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 Arkans in view of Hodgkiss-Harlow and further in view of Kessler et al (US 2014/0058267) (“Kessler”).
Regarding Claim 4, while Arkans 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 Arkans 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 Arkans in view of Hodgkiss-Harlow and further in view of Tejani (US 2017/0000519).
Regarding Claim 5, while Arkans 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 Arkans 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)].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arkans in view of Hodgkiss-Harlow and further in view of Shutze et al ("Palmar artery aneurysm.") (“Shutze”).
Regarding Claim 1, while Arkans teaches a method (Abstract) comprising:
contacting one or more Doppler ultrasound blood flow sensors with a skin surface (Abstract, Col. 3, L. 5-19, “This allows assessment of the health of the skin tissue by looking at the color and texture of the skin. Skin blood flow can also be assessed by applying sensors such as a laser Doppler flux probe or a photo plethysmographic probe. Finally, an underlying artery can be palpated for pulsatility by hand or by using an electric monitor incorporating a strain sensitive element or continuous wave ultrasonic Doppler probe that is placed on the skin over the artery.” An ultrasonic Doppler probe is placed in contact with skin surface over the artery, Col. 3, L. 20-33, where the artery being measured is the dorsalis pedis artery at the midtarsal region);
aligning the one or more Doppler ultrasound blood flow sensors with one or more respective blood vessels of a pedal arch such that each Doppler ultrasound blood flow sensor is aligned with a respective blood vessel of the pedal arch (Abstract, Col. 3, L. 5-33, “Finally, an underlying artery can be palpated for pulsatility by hand or by using an electric monitor incorporating a strain sensitive element or continuous wave ultrasonic Doppler probe that is placed on the skin over the artery.” Indicating the ultrasonic Doppler blood flow sensor is aligned with a blood vessel in the monitoring region of a pedal arch);
processing Doppler signals received from the one or more Doppler ultrasound blood flow sensors to determine a blood flow associated with each Doppler ultrasound blood flow sensor (Col. 9, L. 6 – Col. 10, L. 5, Doppler probes are used to evaluate blood flow and the effectiveness of treatments related to blood flow); and
Arkans further teaches that is known in the art that blood flow acceleration is related to patient health and pathology (Col. 2, L. 27-45, treatments for blood flow related conditions involve modulating blood flow acceleration).
Examiner will note here that the reference of Tehan from the previous action was removed was also measuring blood flow at the dorsal pedis artery. However, Examiner reads the claims amendments as changing the scope from stating that the entirety of the dorsal pedis artery is necessarily part of the pedal arch to now stating that only the blood vessels present in the pedal arch read on the claim. Examiner considers Arkans as reading on this claim language as the measured area of the dorsal pedis artery between regions A and B in Arkans is shown to be limited to the pedal arch area.
Arkans fails to teach processing Doppler signals received from the one or more Doppler ultrasound blood flow sensors to determine a blood flow acceleration time respectively associated with each Doppler ultrasound blood flow sensor; and
for each blood vessel, processing the respective blood flow acceleration time to assess a blood flow pathology,
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 of Arkans to be performed by blood flow acceleration time as taught in Hodgkiss-Harlow as this provides a standardized metric with which to consider blood flow in Arkans. This simplifies the creation of thresholds, identification of improvements, and judgement of patient-specific changes in the blood flow. 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.
Yet their combined efforts fail to teach performing this method for the monitoring location of the deep palmar arch.
However Shutze teaches the identification of a blood flow abnormality for the palmar artery (Abstract) where the identification was made by ultrasound imaging (p50, Fig. 1.(a), Col. 1, p51, Col. 2, “he usual presentation of PAA and DAA is a painless pulsatile mass in the palm or digit. Digital clubbing ( 13 ) and median nerve compression symptoms ( 1 ) have been reported. Th e diagnosis has usually been made by arteriography, but more recently it has been established by ultrasound, CT angiography, and magnetic resonance (MR) angiography ( 4 ). Th e advances in ultrasound, CT, and MR have made arteriography no longer mandatory, and these noninvasive modalities can be used successfully for diagnosis and surgical planning.”)
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 time of Arkans and Hodgkiss-Harlow be additionally applied to the deep palmar arch as Shutze teaches both that similar blood flow restricting conditions can also be found in the deep palmar artery and that ultrasound imaging can characterize such blood flow changes in this blood vessel. Thus one is extending the utility of the method of Arkans and Hodgkiss-Harlow by applying it other blood vessels, preventing blood flow-related issues noted by Arkans (Col. 1, L. 26-29, “In elderly patients who have undergone multiple vascular procedures, the deterioration of arterial blood flow can lead to Severe pain (ischemic neuritis), tissue loss (arterial ulcers), or toe loss (gangrene).”).
Response to Arguments
Applicant’s amendments and arguments filed 4/30/2026 with respect to the 35 USC 103 rejections have been fully considered and are persuasive. Applicant argues that the dorsal pedis artery is a parent pedal artery and that the claims have now been limited to the blood vessels of a pedal arch, a teaching not clearly found in Tehan. Examiner agrees that Tehan does not specifically measure the dorsal pedis artery in the region the artery coincides with the pedal arch. Thus the rejection (s) is/are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Arkans and Hodgkiss-Harlow. In Arkans, the measured blood vessel of the pedal arch is again the dorsal pedis artery, but Arkans clearly shows that the measuring region is a region of the dorsal pedis artery that coincides with the pedal arch (Fig. 6, the measuring region of the dorsal pedis artery 102 between points A and B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
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