DETAILED ACTION
Summary
Claims 2-15, 17-30 are pending in the application. Claims 3-8, 10-15, 17-22, 24-26, and 28-30 rejected under 35 USC 112(b). Claims 2 and 9 rejected under 35 USC 102(a)(1). Claims 2-3, 9, 14-15, 17-24, 26-28, and 30 are rejected under 35 USC 103.
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 .
Claim Objections
Claims 1, 14, 16, and 19 are objected to because of the following informalities:
Claim 2 recites “each hemodynamic Doppler sample” in lines 10-11. It should recites “each of the hemodynamic Doppler samples”.
Claim 2 recites “a hemodynamic response” in line 12. It should recite “the hemodynamic response”.
Claim 3 recites “each hemodynamic Doppler sample” in lines 10-11. It should recites “each of the hemodynamic Doppler samples”.
Claim 3 recites “a hemodynamic response” in line 12. It should recite “the hemodynamic response”.
Claim 7 recites “n being an integer comprised between 10 and 100” in lines 2-3. It should recite “n being an integer between 10 and 100”.
Claim 8 recites “n being an integer comprised between 10 and 100” in lines 3-4. It should recite “n being an integer between 10 and 100”.
Claim 11 recites “each hemodynamic Doppler sample” in lines 10-11. It should recites “each of the hemodynamic Doppler samples”.
Claim 11 recites “a hemodynamic response” in line 12. It should recite “the hemodynamic response”.
Claim 11 recites “the retina” in line 17. It should recite “a retina”.
Claim 14 recites “each hemodynamic Doppler sample” in lines 10-11. It should recites “each of the hemodynamic Doppler samples”.
Claim 14 recites “a hemodynamic response” in line 12. It should recite “the hemodynamic response”.
Claim 14 recites “the peak value” in line 20. It should recite “a peak value”.
Claim 19 recites “each hemodynamic Doppler sample” in line 11. It should recites “each of the hemodynamic Doppler samples”.
Claim 19 recites “a hemodynamic response” in lines 12-13. It should recite “the hemodynamic response”.
Claim 19 recites “in at least one area of interest (20)” in line 13. It should recite “in at least on area of interest”.
Claim 19 recites “the peak value” in line 21. It should recite “a peak value”.
Claim 21 recites “each hemodynamic Doppler sample” in line 10. It should recites “each of the hemodynamic Doppler samples”.
Claim 21 recites “a hemodynamic response” in lines 11-12. It should recite “the hemodynamic response”.
Claim 21 recites “in at least one area of interest (20)” in line 12. It should recite “in at least on area of interest”.
Claim 22 recites “each hemodynamic Doppler sample” in line 10. It should recites “each of the hemodynamic Doppler samples”.
Claim 22 recites “a hemodynamic response” in lines 11-12. It should recite “the hemodynamic response”.
Appropriate correction is required.
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: “a stimulating device” and “a computing module” in claim 19, 21, and 22.
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 stimulating device” will be interpreted as an LED adapted to illuminate the retina, or equivalents thereof, consistent with [0150] of the specification.
“a computing module” will be interpreted as a processor running a computer program, or equivalents thereof, consistent with [0128]-[0129] of the specification.
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.
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 3-8, 10-15, 17-22, 24-26, and 28-30 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 3 recites “said region” in line 6. It is not clear if this is referring to a specific region of “at least one region”, or if this is referring to the entirety of “at least one region”. Clarification is required. For the purposes of examination, the latter definition will be used.
Claim 11 recites “said region” in line 17. It is not clear if this is referring to a specific region of “at least one region”, or if this is referring to the entirety of “at least one region”. Clarification is required. For the purposes of examination, the latter definition will be used.
Claim 11 recites “at least one first eye” in line 17. It is not clear if this is suggesting that both eyes can be considered “first” eyes, as “first” suggests only one. Clarification is required. For the purposes of examination, only one eye of the “at least one first eye” will be considered a first eye.
Claim 11 recites “said first eye” in line 20. It is not clear if this is referring to a specific first eye of “at least one first eye”, or if this is referring to the entirety of “at least one first eye”. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 13 recites “a human patient” in line 5. It is not clear if this is referring to the human previously set forth, or if this is setting forth a new patient. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 13 recites the limitation "said functional imaging" in line 7. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the functional imaging will be interpreted as referring to the ultrasound measurements.
Claim 14 recites “said region” in line 7. It is not clear if this is referring to a specific region of “at least one region”, or if this is referring to the entirety of “at least one region”. Clarification is required. For the purposes of examination, the latter definition will be used.
Claim 14 recites “said stimulus” in line 10. It is not clear if this is referring to a specific region of “at least one stimulus”, or if this is referring to the entirety of “at least one stimulus”. Clarification is required. For the purposes of examination, the latter definition will be used.
Claim 19 recites “said stimulus” in lines 9-10. It is not clear if this is referring to a specific stimulus of “at least one stimulus”, or if this is referring to the entirety of “at least one stimulus”. Clarification is required. For the purposes of examination, the latter definition will be used.
Claim 21 recites “said stimulus” in lines 9-10. It is not clear if this is referring to a specific stimulus of “at least one stimulus”, or if this is referring to the entirety of “at least one stimulus”. Clarification is required. For the purposes of examination, the latter definition will be used.
Claim 21 recites “said area of interest” in line 16. It is not clear if this is referring to a specific area of “at least one area of interest”, or if this is referring to the entirety of “at least one area of interest”. Clarification is required. For the purposes of examination, the latter definition will be used.
Claim 22 recites “said stimulus” in lines 9-10. It is not clear if this is referring to a specific stimulus of “at least one stimulus”, or if this is referring to the entirety of “at least one stimulus”. Clarification is required. For the purposes of examination, the latter definition will be used.
All claims dependent from the above claims rejected under 35 USC 112(b) are also rejected, as the limitations of the dependent claims fail to cure the deficiencies identified above.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 2 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Urban et al. (Urban, Alan, et al. “Chronic assessment of cerebral hemodynamics during rat forepaw electrical stimulation using functional ultrasound imaging.” Neuroimage 101 (2014): 138-149.).
Regarding Claim 2, Urban teaches a method for measuring neurovascular coupling in a nervous system of a human or animal, said nervous system having a vascular network (Abstract), said method including
(a) delivering at least one stimulus to said nervous system (Pg. 140, Electrical Stimulation, Col 2), said at least one stimulus activating said nervous system in at least one region thereof (Fig. 3C shows the activation of the nervous system in an region), which in turn causes a hemodynamic response in said vascular network in said at least one region (Pg. 143, Col 1, ¶ 2);
(b) performing a series of at least 10 ultrasound measurements of said at least one region (Pg. 140, Col 1, ¶ 5) (each image is a measurement) with an ultrasound probe having an array of at least one ultrasound transducer (Pg. 140, Col 1, ¶ 2), to obtain hemodynamic Doppler samples of said vascular network in said at least one region (Pg. 140, Ultrasound imaging procedure)+(Pg. 140, Col 2, Analysis of hemodynamics), during a recording period of at least 10 seconds including said stimulus (Pg. 140, Col 2, Electrical Stimulation)+(Pg. 142, Col 1, ¶ 2), each hemodynamic Doppler sample having a certain Doppler signal (Pg. 140, Col 1, ¶ 5-6) (the pixels of the Doppler image represent a Doppler signal);
(c) computing, from said series of ultrasound measurements (Pg. 140, Col 2, Analysis of hemodynamics), a hemodynamic response to said at least one stimulus in at least one area of interest in said at least one region during said recording period (Pg. 144, Fig 4A), said hemodynamic response including values of at least one hemodynamic parameter in said vascular network based on said Doppler signals of said hemodynamic Doppler samples of said series of ultrasound measurements (Pg. 144, Fig 4B, ΔCBF is the hemodynamic parameter) (Pg. 143, Col 2, ¶ 2)
wherein said at least one area of interest is determined automatically based on: an activation map of said vascular network, estimated from correlation of said at least on stimulus (Pg. 140, Col 2, Analysis of hemodynamics) (the system overlays the activation map with the Doppler signals of the vascular network).
Regarding Claim 9, Urban teaches the invention as claimed. Urban further teaches wherein said at least one region belongs either to the brain of said human or animal (Pg. 140, Col 1, ¶ 5) (the region belongs to the brain of an animal).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Urban in view of Vignon (U.S PGPub 2019/0254630 A1).
Regarding Claim 3, Urban teaches a method for measuring neurovascular coupling in a nervous system of a human or animal, said nervous system having a vascular network (Abstract), said method comprising:
(a) delivering at least one stimulus to said nervous system (Pg. 140, Electrical Stimulation, Col 2), said at least one stimulus activating said nervous system in at least one region thereof (Fig. 3C shows the activation of the nervous system in an region), which in turn causes a hemodynamic response in said vascular network in said region (Pg. 143, Col 1, ¶ 2);
(b) performing a series of at least 10 ultrasound measurements of said at least one region (Pg. 140, Col 1, ¶ 5) (each image is a measurement) with an ultrasound probe having an array of at least one ultrasound transducer (Pg. 140, Col 1, ¶ 2), to obtain hemodynamic Doppler samples of said vascular network in said at least one region (Pg. 140, Ultrasound imaging procedure)+(Pg. 140, Col 2, Analysis of hemodynamics), during a recording period of at least 10 seconds including said stimulus (Pg. 140, Col 2, Electrical Stimulation)+(Pg. 142, Col 1, ¶ 2), each hemodynamic Doppler sample having a certain Doppler signal (Pg. 140, Col 1, ¶ 5-6) (the pixels of the Doppler image represent a Doppler signal);
(c) computing, from said series of ultrasound measurements (Pg. 140, Col 2, Analysis of hemodynamics), a hemodynamic response to said at least one stimulus in at least one area of interest in said at least one region during said recording period (Pg. 144, Fig 4A), said hemodynamic response including values of at least one hemodynamic parameter in said vascular network based on said Doppler signals of said hemodynamic Doppler samples of said series of ultrasound measurements (Pg. 144, Fig 4B, ΔCBF is the hemodynamic parameter) (Pg. 143, Col 2, ¶ 2)
wherein said ultrasound measurements correspond to a direction of depth from said ultrasound probe (Pg. 140, Col 1, ¶ 5).
Urban fails to explicitly teach one or several lines in a direction of depth.
Vignon teaches an ultrasonic imaging method (Abstract). This system obtains ultrasound measurement using one or several lines [0021] in a direction of depth [0021].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of obtaining ultrasound measurements of Urban with to use lines in a direction of depth, as taught by Vignon, as the substitution for one known method of obtaining ultrasonic measurements with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results are reasonably predictable.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Urban in view of West et al. (West, Kathryn L., et al. "BOLD hemodynamic response function changes significantly with healthy aging." NeuroImage 188 (2019): 198-207.).
Regarding Claim 14, Urban teaches a method for measuring neurovascular coupling in a nervous system of a human or animal, said nervous system having a vascular network (Abstract), said method comprising:
(a) delivering at least one stimulus to said nervous system (Pg. 140, Electrical Stimulation, Col 2), said at least one stimulus activating said nervous system in at least one region thereof (Fig. 3C shows the activation of the nervous system in an region), which in turn causes a hemodynamic response in said vascular network in said at least one region (Pg. 143, Col 1, ¶ 2);
(b) performing a series of at least 10 ultrasound measurements of said at least one region (Pg. 140, Col 1, ¶ 5) (each image is a measurement) with an ultrasound probe having an array of at least one ultrasound transducer (Pg. 140, Col 1, ¶ 2), to obtain hemodynamic Doppler samples of said vascular network in said at least one region (Pg. 140, Ultrasound imaging procedure)+(Pg. 140, Col 2, Analysis of hemodynamics), during a recording period of at least 10 seconds including said stimulus (Pg. 140, Col 2, Electrical Stimulation)+(Pg. 142, Col 1, ¶ 2), each hemodynamic Doppler sample having a certain Doppler signal (Pg. 140, Col 1, ¶ 5-6) (the pixels of the Doppler image represent a Doppler signal);
(c) computing, from said series of ultrasound measurements (Pg. 140, Col 2, Analysis of hemodynamics), a hemodynamic response to said at least one stimulus in at least one area of interest in said at least one region during said recording period (Pg. 144, Fig 4A), said hemodynamic response including values of at least one hemodynamic parameter in said vascular network based on said Doppler signals of said hemodynamic Doppler samples of said series (Pg. 144, Fig 4B, ΔCBF is the hemodynamic parameter) (Pg. 143, Col 2, ¶ 2).
Urban fails to explicitly teach wherein at least one response parameter is computed from the hemodynamic response, said at least on parameter being a fall time computed from a time of the peak value of the hemodynamic response to a minimum value of the hemodynamic response following said peak value.
West teaches a method of analyzing the hemodynamic response (Abstract). This system obtains a response parameter of a fall time computed from a time of the peak value to a minimum value of the hemodynamic response (Fig. 1, peak-to-trough) (Pg. 200, Col 1, ¶ 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the response parameter of Urban with a fall time from the peak value to a minimum value of the hemodynamic response, as taught by West, as the substitution for one known hemodynamic response parameter with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using the fall time from peak value to a minimum value are reasonably predictable.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Urban in view of West as applied to claim 14 above, and further in view of Itu et al. (U.S PGPub 2016/0148372 A1).
Regarding Claim 15, the combination of references teaches the invention substantially as claimed. Urban fails to explicitly teach wherein said at least one response parameter is obtained by fitting a multiparameter function on said hemodynamic response and determining said at least one response parameter on said multiparameter function after fitting.
Itu teaches a system for hemodynamic imaging (Abstract). This wherein said at least one response parameter is obtained by fitting a multiparameter function on said hemodynamic response [0104] (gamma function is a multiparameter function) and determining said at least one response parameter on said multiparameter function after fitting [0105] (time to peak is determined).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to determine the response parameter from a fitted multiparameter function, as taught by Itu, because this corrects for noise in the data, thereby increasing the accuracy of the determined parameter, as recognized by Itu [0104].
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Urban in view of Sauvage et al. (Sauvage, Jack, et al. "4D functional imaging of the rat brain using a large aperture row-column array." IEEE transactions on medical imaging 39.6 (2019): 1884-1893.) and West.
Regarding Claim 19, Urban teaches apparatus for measuring neurovascular coupling in a nervous system of a human or animal, said nervous system having a vascular network (Abstract), said apparatus including
said at least one stimulus activating said nervous system in at least one region thereof (Fig. 3C shows the activation of the nervous system in an region), which in turn causes a hemodynamic response in said vascular network in said at least one region (Pg. 143, Col 1, ¶ 2);
(b) an ultrasound measuring device (Pg. 140, Col 1, ¶ 2) adapted to perform a series of at least 10 ultrasound measurements of said at least one region (Pg. 140, Col 1, ¶ 5) (each image is a measurement) with an ultrasound probe having an array of at least one ultrasound transducer (Pg. 140, Col 1, ¶ 2), to obtain hemodynamic Doppler samples of said vascular network in said at least one region (Pg. 140, Ultrasound imaging procedure)+(Pg. 140, Col 2, Analysis of hemodynamics), during a recording period of at least 10 seconds including said stimulus (Pg. 140, Col 2, Electrical Stimulation)+(Pg. 142, Col 1, ¶ 2), each hemodynamic Doppler sample having a certain Doppler signal (Pg. 140, Col 1, ¶ 5-6) (the pixels of the Doppler image represent a Doppler signal);
(c) a computing module adapted to compute, from said series of ultrasound measurements (Pg. 140, Col 2, Analysis of hemodynamics), a hemodynamic response to said stimulus in at least one area of interest in said at least one region during said recording period (Pg. 144, Fig 4A), said hemodynamic response including values of at least one hemodynamic parameter in said vascular network based on said Doppler signals of said hemodynamic Doppler samples of said series of ultrasound measurements (Pg. 144, Fig 4B, ΔCBF is the hemodynamic parameter) (Pg. 143, Col 2, ¶ 2).
Urban fails to explicitly teach a stimulating device adapted to deliver at least one stimulus to said nervous system (as the limitation is interpreted under 35 USC 112f, the stimulating device must be an LED adapted to illuminate the retina, or equivalents thereof, as detailed above).
Sauvage teaches a system for functional ultrasound imaging of the brain (Abstract). This system uses an LED for illuminating the retina in order to stimulate the brain (Pg. 1886, Fig b.1, protocol 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the stimulation of Urban with an optical stimulation, as taught by Sauvage, as the substitution for one known method for simulating the brain with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of stimulating the brain with an LED are reasonably predictable.
Urban fails to explicitly teach wherein at least one response parameter is computed from the hemodynamic response, said at least on parameter being a fall time computed from a time of the peak value of the hemodynamic response to a minimum value of the hemodynamic response following said peak value.
West teaches a method of analyzing the hemodynamic response (Abstract). This system obtains a response parameter of a fall time computed from a time of the peak value to a minimum value of the hemodynamic response (Fig. 1, peak-to-trough) (Pg. 200, Col 1, ¶ 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the response parameter of Urban with a fall time from the peak value to a minimum value of the hemodynamic response, as taught by West, as the substitution for one known hemodynamic response parameter with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using the fall time from peak value to a minimum value are reasonably predictable.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Urban in view of Sauvage.
Regarding Claim 21, Urban teaches apparatus for measuring neurovascular coupling in a nervous system of a human or animal, said nervous system having a vascular network (Abstract), said apparatus comprising:
said at least one stimulus activating said nervous system in at least one region thereof (Fig. 3C shows the activation of the nervous system in an region), which in turn causes a hemodynamic response in said vascular network in said at least one region (Pg. 143, Col 1, ¶ 2);
(b) an ultrasound measuring device (Pg. 140, Col 1, ¶ 2) adapted to perform a series of at least 10 ultrasound measurements of said at least one region (Pg. 140, Col 1, ¶ 5) (each image is a measurement) with an ultrasound probe having an array of at least one ultrasound transducer (Pg. 140, Col 1, ¶ 2), to obtain hemodynamic Doppler samples of said vascular network in said at least one region (Pg. 140, Ultrasound imaging procedure)+(Pg. 140, Col 2, Analysis of hemodynamics), during a recording period of at least 10 seconds including said stimulus (Pg. 140, Col 2, Electrical Stimulation)+(Pg. 142, Col 1, ¶ 2), each hemodynamic Doppler sample having a certain Doppler signal (Pg. 140, Col 1, ¶ 5-6) (the pixels of the Doppler image represent a Doppler signal);
(c) a computing module adapted to compute, from said series of hemodynamic Doppler measurements (Pg. 140, Col 2, Analysis of hemodynamics), a hemodynamic response to said stimulus in at least one area of interest in said at least one region during said recording period (Pg. 144, Fig 4A), said hemodynamic response including values of at least one hemodynamic parameter in said vascular network based on said Doppler signals of said hemodynamic Doppler samples of said series of ultrasound measurements (Pg. 144, Fig 4B, ΔCBF is the hemodynamic parameter) (Pg. 143, Col 2, ¶ 2),
wherein said computing module is adapted to automatically determined said area of interest based on: an activation map of said vascular network, estimated from correlation of said at least on stimulus (Pg. 140, Col 2, Analysis of hemodynamics) (the system overlays the activation map with the Doppler signals of the vascular network).
Urban fails to explicitly teach a stimulating device adapted to deliver at least one stimulus to said nervous system (as the limitation is interpreted under 35 USC 112f, the stimulating device must be an LED adapted to illuminate the retina, or equivalents thereof, as detailed above).
Sauvage teaches a system for functional ultrasound imaging of the brain (Abstract). This system uses an LED for illuminating the retina in order to stimulate the brain (Pg. 1886, Fig b.1, protocol 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the stimulation of Urban with an optical stimulation, as taught by Sauvage, as the substitution for one known method for simulating the brain with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of stimulating the brain with an LED are reasonably predictable.
Claims 17, are rejected under 35 U.S.C. 103 as being unpatentable over Urban in view of Sauvage as applied to claim 21 above, and further in view of Hamilton et al. (U.S PGPub 2016/0256130 A1).
Regarding Claim 17, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein said computing module is adapted to diagnose whether said hemodynamic response corresponds to a predetermined disease.
Hamilton teaches a system for diagnosing neurological disorders (Abstract). This system diagnoses whether a hemodynamic response corresponds to a predetermined disease [0041]+[0063].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to diagnose whether the hemodynamic response corresponds to a predetermined disease, as taught by Hamilton, because this allows for more accurate and earlier diagnosis of disease, thereby improving patient outcomes, as recognized by Hamilton [0010].
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Urban in view of Sauvage as applied to claim 21 above, and further in view of Alwatban et al. (U.S PGPub 2020/0288994 A1).
Regarding Claim 18, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein said computing module is adapted to monitor efficiency of a medical treatment against a predetermined neurodegenerative or cardiovascular disease, based on said hemodynamic response.
Alwatban teaches a system for analyzing cerebral reactivity (Abstract). This system uses the cerebral reactivity to monitor the efficiency of a medical treatment for a predetermined neurodegenerative disease [0015]+[0039].
It would have been obvious to one of ordinary skill in the art before the effective filing date to monitor the efficiency of a medical treatment, as taught by Alwatban, because this improves the care of the patient by informing the physician to change the treatment if it is proving ineffective.
Claim 20 are rejected under 35 U.S.C. 103 as being unpatentable over Urban in view of Sauvage and Hamilton as applied to claim 21 above, and further in view of Mourad et al (U.S PGPub 2005/0015009 A1).
Regarding Claim 20, the combination of references teaches the invention substantially as claimed. Urban fails to explicitly teach wherein said computing module is adapted to use a neural network trained to determine whether the hemodynamic response is normal and/or to determine whether the hemodynamic response corresponds to the predetermined disease.
Hamilton further teaches wherein said computing module is adapted to use a machine learning model to determine whether the hemodynamic response is normal [0064]+[0110].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to diagnose whether the hemodynamic response corresponds to a predetermined disease, as taught by Hamilton, because this allows for more accurate and earlier diagnosis of disease, thereby improving patient outcomes, as recognized by Hamilton [0010].
The combination is silent that the machine learning model is a neural network.
Mourad teaches a for ultrasonic doppler (Abstract). This system recognizes analyzing the acoustic data using a neural network as an alternative to a support vector machine [0062].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the machine learning algorithm of Hamilton with a neural network, as taught by Mourad, as the substitution for one known machine learning algorithm with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a trained neural network are reasonably predictable.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Urban in view of Sauvage and Vignon.
Regarding Claim 22, Urban teaches apparatus for measuring neurovascular coupling in a nervous system of a human or animal, said nervous system having a vascular network (Abstract), said apparatus including
said at least one stimulus activating said nervous system in at least one region thereof (Fig. 3C shows the activation of the nervous system in an region), which in turn causes a hemodynamic response in said vascular network in said at least one region (Pg. 143, Col 1, ¶ 2);
(b) an ultrasound measuring device (Pg. 140, Col 1, ¶ 2) adapted to perform a series of at least 10 ultrasound measurements of said at least one region (Pg. 140, Col 1, ¶ 5) (each image is a measurement) with an ultrasound probe having an array of at least one ultrasound transducer (Pg. 140, Col 1, ¶ 2), to obtain hemodynamic Doppler samples of said vascular network in said at least one region (Pg. 140, Ultrasound imaging procedure)+(Pg. 140, Col 2, Analysis of hemodynamics), during a recording period of at least 10 seconds including said stimulus (Pg. 140, Col 2, Electrical Stimulation)+(Pg. 142, Col 1, ¶ 2), each hemodynamic Doppler sample having a certain Doppler signal (Pg. 140, Col 1, ¶ 5-6) (the pixels of the Doppler image represent a Doppler signal);
(c) a computing module adapted to compute, from said series of ultrasound measurements (Pg. 140, Col 2, Analysis of hemodynamics), a hemodynamic response to said at least one stimulus in at least one area of interest in said at least one region during said recording period (Pg. 144, Fig 4A), said hemodynamic response including values of at least one hemodynamic parameter in said vascular network based on said Doppler signals of said hemodynamic Doppler samples of said series of ultrasound measurements (Pg. 144, Fig 4B, ΔCBF is the hemodynamic parameter) (Pg. 143, Col 2, ¶ 2)
said ultrasound measurements correspond to a direction of depth from said ultrasound probe (Pg. 140, Col 1, ¶ 5).
Urban fails to explicitly teach a stimulating device adapted to deliver at least one stimulus to said nervous system (as the limitation is interpreted under 35 USC 112f, the stimulating device must be an LED adapted to illuminate the retina, or equivalents thereof, as detailed above).
Sauvage teaches a system for functional ultrasound imaging of the brain (Abstract). This system uses an LED for illuminating the retina in order to stimulate the brain (Pg. 1886, Fig b.1, protocol 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the stimulation of Urban with an optical stimulation, as taught by Sauvage, as the substitution for one known method for simulating the brain with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of stimulating the brain with an LED are reasonably predictable.
Urban fails to explicitly teach one or several lines in a direction of depth.
Vignon teaches an ultrasonic imaging method (Abstract). This system obtains ultrasound measurement using one or several lines [0021] in a direction of depth [0021].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of obtaining ultrasound measurements of Urban with to use lines in a direction of depth, as taught by Vignon, as the substitution for one known method of obtaining ultrasonic measurements with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results are reasonably predictable.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Urban in view of Kotliar et al. (Kotliar, Konstantin, et al. "Altered neurovascular coupling as measured by optical imaging: a biomarker for Alzheimer’s disease." Scientific reports 7.1 (2017): 12906.).
Regarding Claim 23, Urban teaches the invention substantially as claimed. Urban fails to explicitly teach diagnosing whether said hemodynamic response corresponds to a predetermined disease.
Kotliar teaches a method of analyzing Alzheimer’s diseases (Abstract). This system diagnoses that the hemodynamic response corresponds to a predetermined disease (Pg. 2, ¶ 2) (Pg. 9, Conclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Urban to diagnose whether the hemodynamic response corresponds to a predetermined disease, as taught by Kotliar, because this allows for an easier method of diagnosing and monitoring Alzheimer’s disease, as recognized by Kotliar (Pg. 9, Conclusion).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Urban and Vignon as applied to claim 3 above, and further in view of Kotliar.
Regarding Claim 24, Urban teaches the invention substantially as claimed. Urban fails to explicitly teach diagnosing whether said hemodynamic response corresponds to a predetermined disease.
Kotliar teaches a method of analyzing Alzheimer’s diseases (Abstract). This system diagnoses that the hemodynamic response corresponds to a predetermined disease (Pg. 2, ¶ 2) (Pg. 9, Conclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined to diagnose whether the hemodynamic response corresponds to a predetermined disease, as taught by Kotliar, because this allows for an easier method of diagnosing and monitoring Alzheimer’s disease, as recognized by Kotliar (Pg. 9, Conclusion).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Urban and West as applied to claim 14 above, and further in view of Kotliar.
Regarding Claim 24, Urban teaches the invention substantially as claimed. Urban fails to explicitly teach diagnosing whether said hemodynamic response corresponds to a predetermined disease.
Kotliar teaches a method of analyzing Alzheimer’s diseases (Abstract). This system diagnoses that the hemodynamic response corresponds to a predetermined disease (Pg. 2, ¶ 2) (Pg. 9, Conclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined to diagnose whether the hemodynamic response corresponds to a predetermined disease, as taught by Kotliar, because this allows for an easier method of diagnosing and monitoring Alzheimer’s disease, as recognized by Kotliar (Pg. 9, Conclusion).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Urban in view of Roth et al. (U.S PGPub 2024/0099687 A1).
Regarding Claim 27, Urban teaches the invention substantially as claimed. Urban fails to explicitly teach wherein efficiency of a medical treatment against a predetermined disease is monitored based on said hemodynamic response.
Roth teaches a hemodynamic monitoring device (Abstract). This system monitors the efficiency of a medical treatment to a predetermined disease based on a hemodynamic response [0077].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Urban monitor the efficiency of treatment, as taught by Roth, because this improves the treatment of the patient, as recognized by Roth [0078].
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Urban and Vignon as applied to claim 3 above, and further in view of Roth.
Regarding Claim 28, Urban teaches the invention substantially as claimed. Urban fails to explicitly teach wherein efficiency of a medical treatment against a predetermined disease is monitored based on said hemodynamic response.
Roth teaches a hemodynamic monitoring device (Abstract). This system monitors the efficiency of a medical treatment to a predetermined disease based on a hemodynamic response [0077].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system monitor the efficiency of treatment, as taught by Roth, because this improves the treatment of the patient, as recognized by Roth [0078].
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Urban and West as applied to claim 14 above, and further in view of Roth.
Regarding Claim 30, Urban teaches the invention substantially as claimed. Urban fails to explicitly teach wherein efficiency of a medical treatment against a predetermined disease is monitored based on said hemodynamic response.
Roth teaches a hemodynamic monitoring device (Abstract). This system monitors the efficiency of a medical treatment to a predetermined disease based on a hemodynamic response [0077].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system monitor the efficiency of treatment, as taught by Roth, because this improves the treatment of the patient, as recognized by Roth [0078].
Allowable Subject Matter
Claims 4-8, 10-13, 25, and 29 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: Claim 11 is would be allowable if rewritten to overcome the rejections under 35 USC 112(b) for substantially the same reasons set forth on pages 15-16 of the non-final rejection mailed 9/18/2025. Claims 4-8, 10, 12-13, 25, and 29 necessarily contain all the limitations of claim 11, and would be allowable by virtue of their dependency.
Response to Arguments
Applicant's arguments filed 2/18/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claims 2, 3, 14, 19, 21, and 22 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. The claims remain rejected for the reasons set forth above.
Applicant argues “each Doppler sample” does not seem erroneous. The Examiner disagrees. The claim would more clearly show it is referring to the hemodynamic Doppler samples previously set forth if amended in the manner discussed above.
Applicant argues the stimulating device could refer to different devices beyond the LED device. The Examiner disagrees. The “stimulating device” is interpreted under 35 USC 112(f), and therefore the interpretation must be “is the structure, material or act described in the specification as performing the entire claimed function and equivalents to the disclosed structure, material or act” (MPEP 2181). The only structure disclosed for performing the claimed function in the specification is the LED. While other possible methods of stimulating the patient are disclosed, the structure for performing those methods are not disclosed, and those functions are therefore considered beyond the scope of the claim.
Conclusion
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.
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/SEAN D MATTSON/Primary Examiner, Art Unit 3798