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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/10/2025 has been considered by the examiner.
Allowable Subject Matter
The indicated allowability of claims 4, 5, and 16 (now incorporated into claims 1, 5, and 13) is withdrawn in view of the newly discovered reference(s) to Wolf and de Groot. Rejections based on the newly cited reference(s) follow.
Response to Amendment
Claims 2-4, 7-12, and 14-20 are cancelled, and claims 1, 5-6, and 13 remain pending in the application in response to the applicant’s amendments to the rejections previously set forth in the Non-Final Office Action mailed 09/24/2025.
Response to Arguments
Applicant’s arguments filed 02/24/2025 with respect to claim(s) 1, 5, and 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Given the amendments to claim 5, reference to de Groot is being relied upon to teach dependent claim 6 more-consistently with the instant claim language, as shown below.
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.
Claims 1, 5-6, and 13 are 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 1 recites the limitation “the extremity” and "the neurovascular index". There is insufficient antecedent basis for this limitation in the claim.
For claim 1, the limitation “determine an arteriovenous (AV) shunting score for the extremity based on the neurovascular index and a predetermined extremity score” is indefinite. It is unclear if the neurovascular index, the predetermined extremity score, neither, or both corresponds to the determined fourth information, third information, second information, first information, information that is not recited in the claim, or a combination thereof.
For the purpose of advancing prosecution, the examiner assumes the second information is the neurovascular index and the predetermined extremity score (see now cancelled Claim 3 – “generate the second information by: determining, for an extremity associated with the area, at least one of an anterograde pulsatility index, an anterograde volume flow, a retrograde pulsatility index, and a retrograde volume flow; and determining a neurovascular index for the extremity composed of the at least one of the anterograde pulsatility index, the anterograde volume flow, the retrograde pulsatility index, and the retrograde volume flow”), and to have the “determine an arteriovenous (AV) shunting score…” limitation recited after the “generate a second information…” limitation for clarity.
Claim 5 recites the limitation “the extremity”. There is insufficient antecedent basis for this limitation in the claim. For the purpose of advancing prosecution, the examiner assumes “the extremity” should be “an extremity” for clarity.
For claim 5, the limitation “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 the extremity and at least one additional extremity of the subject” is indefinite. It is unclear if the anterograde volume flows corresponds to the determined fourth information, third information, second information, first information, information that is not recited in the claim, or a combination thereof.
For the purpose of advancing prosecution, the examiner assumes the second information is the sum of respective anterograde volume flows (see Claim 6 – “generate the third information by: determining a decrease in a cumulative anterograde volume flow score”), and to have the “determine a cumulative anterograde volume flow score…” limitation recited after the “generate a second information…” limitation for clarity.
Claim 6 is dependent of claim 5, and therefore rejected under this 112(b) rejection as well.
Claim 13 recites the limitation “the one or more extremities”. There is insufficient antecedent basis for this limitation in the claim. For the purpose of advancing prosecution, the examiner assumes “the one or more extremities” should be “one or more extremities”, removing “the” for clarity.
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 1 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 et 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 1, Lang teaches a 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 (increased capillary permeability) 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 the extremity based on the 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 5-6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lang in view of de Groot et al. (US 20190365256 A1, published December 5, 2019), hereinafter referred to as de Groot.
Regarding claim 5, Lang teaches a 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 (increased capillary permeability) 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 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 the 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 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.”).
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 6, 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 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)).
The motivation for claim 6 was shown previously in claim 5.
Regarding claim 13, 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 (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."), 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 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 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 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 the 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 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 for each detected beat location that is mapped to the skeleton model., as taught in de Groot (see para. 0098-0101).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ward et al. (US 20150031966 A1, published January 29, 2015) discloses determining the change in venous volume in the extremity (Fig. 1, step 112).
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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