Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 07/24/2026 has been entered. Claims 1, 5-6, and 13 are cancelled, and claims 21-24 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every 112(b) rejections previously set forth in the Non-Final Office Action mailed 04/21/2026.
Response to Arguments
Applicant's arguments filed 07/24/2026 have been fully considered but they are not persuasive.
For claim 21, the applicant argues “Lang cannot teach or suggest an ultrasound processor that is configured to execute the instructions to determine an AV shunting score because Lang does not recognize or suggest how to compute it from extremity flow or blood flow metrics.” (see pg. 9, para. 1 of applicant’s remarks), and the examiner disagrees.
The claim recites “determine an arteriovenous (AV) shunting score for an extremity based on a neurovascular index and a predetermined extremity score”. The claim does not recite “extremity flow or blood flow metrics”, and the claim does not recite the AV shunting score is based on extremity flow or blood flow metrics.
For claim 21, the applicant argues “Lang does not suggest neurovascular ultrasound analysis following allergen exposure because Lang is focused on edema/interstitial fluid measurement and related physiological assessments” (see pg. 9, para. 2), and the examiner disagrees.
Applicant’s arguments rely on language solely recited in preamble recitations in claim 21. When reading the preamble in the context of the entire claim, the recitation “neurovascular ultrasound analysis” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
For claim 21, the applicant argues “Hence, Wolf cannot be analogous art because its methods of measuring AV shunting require MRI while the instant application does not mention MRI. Claim 21 is directed to neurovascular ultrasound (US) analysis systems not MRI.” (see pg. 10, para. 2), and the examiner disagrees.
The limitation recites “determine an arteriovenous (AV) shunting score for an extremity based on a neurovascular index and a predetermined extremity score”. The claim does not recite the AV shunting score is based on ultrasound data or blood flow, only “a neurovascular index” and “a predetermined extremity score”. The claim does not specifically recite what is considered a neurovascular index or a predetermined extremity score, or how the neurovascular index or predetermined extremity score is determined. Therefore, under broadest reasonable interpretation, Wolf teaches the limitation.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “comparing pre- and post exposure blood flow changes to derive a neurovascular index” and “an AV shunting score to diagnose an allergic reaction” (see pg. 11, para. 3)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
For claim 22, the applicant argues “de Groot teaches methods of determining pulse wave velocity, for example for blood pressure monitoring not flow measurements per se.” (see pg. 15, para. 3), and the examiner disagrees.
de Groot teaches measuring blood flow (see para. 0121 – “The trace B1 shows the blood volume pulse signal extracted by spatiotemporal analysis of the pressure signal P(x,y,t) in the local spatial vicinity of the localized beat (e.g. at some location on left upper arm).”).
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 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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Lang et al. (US 20040127790 A1, published July 1, 2004) in view of R. Wolf al, "Arteriovenous Shunt Visualization in Arteriovenous Malformations with Arterial Spin-Labeling MR Imaging", American Journal of Neuroradiology, vol. 29, no. 4, pp. 681-687, April 2008, hereinafter referred to as Lang and Wolf, respectively.
Regarding claim 21, Lang teaches an neurovascular ultrasound (US) analysis system for determining a presence of an allergic reaction in a subject, comprising:
a US probe configured to transmit a US wave to an area of the subject, wherein the area comprises an internal body structure (see para. 0197 "The ultrasound probe used for interstitial fluid monitoring preferably is specifically adapted for interstitial fluid assessment."); and
a processor communicatively coupled to the US probe (see para. 0244- "Preferably, the probe is autonomous and includes the components necessary to accomplish signal processing and display. Preferably, the subject can read the display while the subject is determining their capillary edema status."), wherein the processor is configured to execute instructions to:
receive, via the US probe, a first information describing a reflection of the US wave from the area (see para. 0243 "Since many such dedicated systems will be designed to primarily interrogate one particular type of capillary related edema probe site [area], which has a well known anatomy, imaging will not be necessary and signals [first information, reflection of US wave from area] can be displayed as described herein.");
generate a second information describing the internal body structure or a characteristic thereof based on processing the first information (see para. 0058 "The displayed distance between the bone 710 and the skin 720 corresponds to measured ILT [interstitial fluid thickness, internal body structure].");
generate a third information describing a change in a circulatory system of the subject based on processing the second information (see para. 0267 "Presence of capillary related edema can be diagnosed in patients with pathologically increased capillary permeability, if ILT at a given anatomic site such as the pretibial region is elevated above a reference value (e.g. that of age, sex, race, or weight-matched controls). The severity of the pathologic increase in capillary permeability [third information] can be assessed using ultrasound measurements of ILT [second information].");
determine the presence of the allergic reaction to a potential allergen in the subject based on the third information (see para. 0237 "The present invention is particularly well suited for testing capillary related edema in medical conditions that increase capillary blood pressure, increase intracapillary oncotic pressure, or increase capillary permeability [third information].' see para. 0228 "Capillary related edema in venous disorders may preferentially affect the dependent body portions, while capillary related edema in patients with abnormal capillary permeability from allergic reactions may affect both dependent as well as non-dependent body regions."); and
output, via a user interface (display 700) communicatively coupled to the processor, a fourth information indicative of the presence of the allergic reaction (see para. 0058 "FIG. 7 shows one embodiment of the invention comprising a predetermined display arrangement 700that includes symbols or illustrative graphics of preselected anatomical features of the interrogated tissue The position of skin 720 and ultrasound transducer 730 can also provide a diagnostic scale 740 indicating whether the patient's fluid status is normal "normal", elevated "elevated", or critical "critical" for the patient's underlying condition [fourth information indicative of presence of allergic reaction]. Such a diagnostic scale 740 can be useful in multiple medical conditions, e.g. impaired vascular, cardiac, renal, or hepatic function.").
Lang teaches measuring a change in a circulatory system, but does not explicitly teach determining an AV shunting score based on measuring the circulatory system.
Whereas, Wolf, in an analogous field of endeavor, teaches wherein the processor is configured to execute the instructions to determine an arteriovenous (AV) shunting score for an extremity based on a neurovascular index and a predetermined extremity score (see Fig. 1 - "Image evaluation and shunt approximation for a right hemisphere AVM [arteriovenous malformations]. A, CASL [continuous arterial spin-labeled] perfusion M maps. The AV shunt fraction is estimated...").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified measuring a change in a circulatory system, as disclosed in Lang, by also determining an AV shunting score based on measuring the circulatory system, as disclosed in Wolf. One of ordinary skill in the art would have been motivated to make this modification in order to quantify AV shunting longitudinally and following treatment, as taught in Wolf (see pg. 682, col. 1, para. 2).
Claims 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Lang in view of de Groot et al. (US 20190365256 A1, published December5, 2019), hereinafter referred to as de Groot.
Regarding claim 22, Lang teaches an neurovascular ultrasound (US) analysis system for determining a presence of an allergic reaction in a subject, comprising:
a US probe configured to transmit a US wave to an area of the subject, wherein the area comprises an internal body structure (see para. 0197 "The ultrasound probe used for interstitial fluid monitoring preferably is specifically adapted for interstitial fluid assessment."); and
a processor communicatively coupled to the US probe, wherein the processor is configured to execute instructions to:
receive, via the US probe, a first information describing a reflection of the US wave from the area (see para. 0244 - "Preferably, the probe is autonomous and includes the components necessary to accomplish signal processing and display. Preferably, the subject can read the display while the subject is determining their capillary edema status.");
generate a second information describing the internal body structure or a characteristic thereof based on processing the first information (see para. 0058 "The displayed distance between the bone 710 and the skin 720 corresponds to measured ILT [interstitial fluid thickness, internal body structure].");
generate a third information describing a change in a circulatory system of the subject based on processing the second information (see para. 0267 "Presence of capillary related edema can be diagnosed in patients with pathologically increased capillary permeability, if ILT at a given anatomic site such as the pretibial region is elevated above a reference value (e.g. that of age, sex, race, or weight-matched controls). The severity of the pathologic increase in capillary permeability [third information] can be assessed using ultrasound measurements of ILT [second information].");
determine the presence of the allergic reaction to a potential allergen in the subject based on the third information (see para. 0237 "The present invention is particularly well suited for testing capillary related edema in medical conditions that increase capillary blood pressure, increase intracapillary oncotic pressure, or increase capillary permeability [third information]. see para. 0228 "Capillary related edema in venous disorders may preferentially affect the dependent body portions, while capillary related edema in patients with abnormal capillary permeability from allergic reactions may affect both dependent as well as non-dependent body regions."); and
output, via a user interface (display 700) communicatively coupled to the processor, a fourth information indicative of the presence of the allergic reaction (see para. 0058 "FIG. 7 shows one embodiment of the invention comprising a predetermined display arrangement 700 that includes symbols or illustrative graphics of preselected anatomical features of the interrogated tissue The position of skin 720 and ultrasound transducer 730 can also provide a diagnostic scale 740 indicating whether the patient's fluid status is normal "normal", elevated "elevated", or critical "critical" for the patient's underlying condition [fourth information indicative of presence of allergic reaction]. Such a diagnostic scale 740 can be useful in multiple medical conditions, e.g. impaired vascular, cardiac, renal, or hepatic function.").
Lang teaches measuring a change in the circulatory system at an extremity (see para. 0065 "...a variety of sites on a leg or an arm..."), but does not explicitly teach measuring volume flow at multiple extremities.
Whereas, de Groot, in an analogous field of endeavor, teaches wherein the processor is configured to execute the instructions to determine a cumulative anterograde volume flow score based on a sum of respective anterograde volume flows of an extremity and at least one additional extremity of the subject (Fig. 4; see para. 0078 "The trace B1 is a first pressure signal extracted by spatiotemporal analysis of the pressure signal P(x,y,t) in the local spatial vicinity of first localized beat, for example at some location on left upper arm [one extremity]. The pressure signal is modulated by the blood volume pulse caused by the pumping heart." So pressure is related to volume; see para. 0079 "The trace B2 isa second pressure pulse signal extracted by spatiotemporal analysis of the pressure signal P(x,y,t) in the local space vicinity of a second localized beat, for example at some location on left upper leg [another extremity]."; see para. 0098 "A beat-skeleton mapping unit 52 is used to identify which locations on the subject's body induced the detected pressure variations in the set B [cumulative anterograde volume flow score] of that contains the extracted locations of blood volume variations in major arteries.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified measuring a change in the circulatory system at an extremity, as disclosed in Lang, by determining a volume flow score based on a sum of volume flow scores at different extremities, as disclosed in de Groot. One of ordinary skill in the art would have been motivated to make this modification in order to detect the location on the subject's body corresponding to a detected pressure variation by mapping the extracted pulse locations in the set to the fitted skeleton, and allow estimation of the actual arterial path length for each detected beat location that is mapped to the skeleton model., as taught in de Groot (see para. 0098-0101).
Furthermore, regarding claim 23, de Groot further teaches wherein the processor is configured to execute the instructions to generate the third information by: determining a decrease in the cumulative anterograde volume flow score; and generating a fifth information describing a change in an immune response associated with the circulatory system based on the decrease in the cumulative anterograde volume flow score (see para. 0129 "The outputs may be stored for retrieval at a later time, for example as a report of the blood pressure or PWV estimates during a preceding night or successive nights."; see para. 0004 "Persistent hypertension is one of the key risk factors for strokes, heart failure and increased mortality." Where a change in blood pressure/volume throughout the body (cumulative volume flow score) can indicate a change in immune response (hypertension, for example)).
Regarding claim 24, Lang teaches a non-transitory computer-readable medium comprising instructions that are executable by a processor to perform operations for neurovascular ultrasound (US) analysis to determine a presence of an allergic reaction, the operations comprising:
instructing, via the processor, a US probe communicatively coupled to the processor to transmit a US wave to an area of a subject, wherein the area comprises an internal body structure (see para. 0197 "The ultrasound probe used for interstitial fluid monitoring preferably is specifically adapted for interstitial fluid assessment.");
receiving, via the processor, a first information describing a reflection of the US wave from the area (see para. 0243 "Since many such dedicated systems will be designed to primarily interrogate one particular type of capillary related edema probe site [area], which has a well known anatomy, imaging will not be necessary and signals [first information, reflection of US wave from area] can be displayed as described herein.");
generating, via the processor, a second information describing the internal body structure or a characteristic thereof based on processing the first information (see para. 0058 "The displayed distance between the bone 710 and the skin 720 corresponds to measured ILT [interstitial fluid thickness, internal body structure].”);
generating, via the processor, a third information describing a change in a circulatory system of the subject based on processing the second information (see para. 0267 "Presence of capillary related edema can be diagnosed in patients with pathologically increased capillary permeability, if ILT at a given anatomic site such as the pretibial region is elevated above a reference value (e.g. that of age, sex, race, or weight-matched controls). The severity of the pathologic increase in capillary permeability [third information] can be assessed using ultrasound measurements of ILT [second information].")
determining, via the processor, the presence of the allergic reaction to a potential allergen in the subject based on the third information (see para. 0237 "The present invention is particularly well suited for testing capillary related edema in medical conditions that increase capillary blood pressure, increase intracapillary oncotic pressure, or increase capillary permeability [third information]."; see para. 0228 "Capillary related edema in venous disorders may preferentially affect the dependent body portions, while capillary related edema in patients with abnormal capillary permeability from allergic reactions may affect both dependent as well as non-dependent body regions.”); and
instructing, via the processor, a user interface (display 700) communicatively coupled to the processor to output a fourth information indicative of the presence of the allergic reaction (see para. 0058 "FIG. 7 shows one embodiment of the invention comprising a predetermined display arrangement 700 that includes symbols or illustrative graphics of preselected anatomical features of the interrogated tissue The position of skin 720 and ultrasound transducer 730 can also provide a diagnostic scale 740 indicating whether the patient's fluid status is normal "normal", elevated "elevated", or critical "critical" for the patient's underlying condition [fourth information indicative of presence of allergic reaction]. Such a diagnostic scale 740 can be useful in multiple medical conditions, e.g. impaired vascular, cardiac, renal, or hepatic function.").
Lang teaches measuring a change in the circulatory system at an extremity (see para. 0065 "...a variety of sites on a leg or an arm..."), but does not explicitly teach measuring volume flow at multiple extremities.
Whereas, de Groot, in an analogous field of endeavor, teaches wherein generating the third information comprises: determining a decrease in a cumulative anterograde volume flow score based on a sum of respective anterograde volume flows of one or more extremities (Fig. 4; see para. 0078 "The trace B1 is a first pressure signal extracted by spatiotemporal analysis of the pressure signal P(x,y,t) in the local spatial vicinity of first localized beat, for example at some location on left upper arm [one extremity]. The pressure signal is modulated by the blood volume pulse caused by the pumping heart." So pressure is related to volume; see para. 0079 "The trace B2 is a second pressure pulse signal extracted by spatiotemporal analysis of the pressure signal P(x,y,t) in the local space vicinity of a second localized beat, for example at some location on left upper leg [another extremity]."; see para. 0098 "A beat-skeleton mapping unit 52 is used to identify which locations on the subject's body induced the detected pressure variations in the set B [cumulative anterograde volume flow score] of that contains the extracted locations of blood volume variations in major arteries."); and
generating a fifth information describing a change in an immune response associated with the circulatory system based on the decrease in the cumulative anterograde volume flow score, wherein the third information comprises the fifth information (see para. 0129 "The outputs may be stored for retrieval at a later time, for example as a report of the blood pressure or PWV estimates during a preceding night or successive nights."; see para. 0004 "Persistent hypertension is one of the key risk factors for strokes, heart failure and increased mortality." Where a change in blood pressure/volume throughout the body (cumulative volume flow score) can indicate a change in immune response (hypertension, for example)).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified measuring a change in the circulatory system at an extremity, as disclosed in Lang, by determining a volume flow score based on a sum of volume flow scores at different extremities, as disclosed in de Groot. One of ordinary skill in the art would have been motivated to make this modification in order to detect the location on the subject's body corresponding to a detected pressure variation by mapping the extracted pulse locations in the set to the fitted skeleton, and allow estimation of the actual arterial path length foreach detected beat location that is mapped to the skeleton model., as taught in de Groot (see para. 0098-0101).
The motivation for claim 23 was shown previously in claim 22.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
J. Wu et al, “Hemodynamic Quantitative Analysis Based on Doppler Ultrasound for Arteriovenous Shunt Stenosis Screening”, IEEE Access, vol. 7, pp. 1-11, 2019 discloses quantitative hemodynamic analysis involving Doppler ultrasound is performed in patients suffering from arteriovenous shunt (AVS) stenosis and undergoing long-term hemodialysis.
Matsubara et al. (US 20150305679 A1, published October 29, 2015) discloses an arteriovenous fistula for hemodialysis may be assessed. The flow of blood through the fistula is measured using the guidewire and the measured flow of blood is used to determine if the fistula is mature.
Donnelly et al. (US 20100130864 A1, published May 27, 2010) discloses measuring the blood flow velocity associated with the arterio-venous fistula using a Doppler ultrasound imaging system.
Krivitski (US 6153109 A, published November 28, 2000) discloses a detector connected to the flow sensor and the first and second sensors determines, at a first flow rate, a first time a first indicator takes to move between the two locations, and at a second flow rate, a second time a second indicator takes to move between the two locations. The shunt flow is then calculated from the first and second times and the first and second flow rates.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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/N.C./Examiner, Art Unit 3798
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