DETAILED ACTION
Summary
Claims 1-3, 5, 7, 9-10, 13, 16-17, 19-22, 25, 27, 30-31, 33, 39, and 41-44 are pending in the application. Claims 1-3, 5, 7, 9-10, 13, 16-17, 19-22, 25, 27, 30-31, and 33 have been withdrawn from further consideration. Claims 39, and 41-44 are rejected under 35 USC 101. Claims 39 and 41 are rejected under 35 USC 102(a)(1). Claims 42-44 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 .
Election/Restrictions
Applicant’s election without traverse of Group III in the reply filed on 8/28/2026 is acknowledged.
Claims 1-3, 5, 7, 9-10, 13, 16-17, 19-22, 25, 27, 30-31, and 33 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/28/2026.
Claim Objections
Claims 39, and 41-44 objected to because of the following informalities:
Claim 39 recite “one more structures” in lines 4-5. It should recite “one or more structures”.
Claim 39 recites “indicative of light” in line 6. It should recite “indicative of the light”.
Claim 39 recites “one more structures” in line 6. It should recite “the one or more structures”.
Claim 41 recites “indicative of light” in line 2. It should recite “indicative of the light”.
Claim 41 recites “one more structures” in line 2. It should recite “the one or more structures”.
Claim 42 recites “normalizing each speckle image” in line 2. It should recite “normalizing each of the plurality of speckle images”.
Claims 42 recites “each normalized speckle image” in line 4. It should recite “each of the normalized speckle images”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 39 and 41-44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a mental process. This judicial exception is not integrated into a practical application because the additional limitations are directed to . The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are directed to insignificant pre-solution activities.
Claim 39 recites an abstract idea without significantly more. The step of “based on the information indicative of light reflected from one or more structures within the brain, determining one or more cerebral blood metrics as a function of time” is directed to an abstract idea of a mental process. A user, looking at information indicative of reflective light, could determine a blood flow metric using only their mind. The claim recites an abstract idea.
The additional limitations do not integrate the abstract idea into a practical application. The steps of causing a laser light to be emitted into a brain and obtaining, using a light detector, information indicative of light reflected from the brain is directed to an insignificant pre-solution activity of gathering data, as it is directed to a necessary data gathering step. The claim is directed to an abstract idea. The claim is not significantly more than the judicial exception. As detailed above, the additional limitations are an insignificant pre-solution activity of gathering data, and does not amount to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 41 is further narrowing the abstract idea of determining a cerebral blood flow metric, and is also directed to an abstract idea. The user, looking at speckle images, could determine a cerebral blood flow metric using only their mind. The claim recites no additional limitations which either integrate the abstract idea into a practical application or amounts to significantly more than the practical application. The claim is not subject matter eligible.
Claim 42 recite an abstract idea without significantly more. The steps of normalizing speckle images, calculating a speckle contract, and adjusting a speckle contrast are steps which can reasonably be done in the human mind/with a pen or paper. A user can normalize the image value by thinking about which areas should be more/less bright, and then calculate the contrast and adjust the value of the contrast by thinking about how contrasted the image appears to be and how much of that contrast is due to noise. Furthermore, the steps or normalizing, calculating, and adjusting are also directed to an abstract idea of a mental process. The normalization step is directed to a mathematical algorithm, and the calculation and adjusting steps are directed to mathematical calculations. The claim recites an abstract idea. The claim recites no additional limitations which either integrate the abstract idea into a practical application or amounts to significantly more than the practical application. The claim is not subject matter eligible.
Claim 43 recites an abstract idea without significantly more. The steps of calculating a cerebral blood flow is directed at an abstract idea of a mental process. A user, looking at speckle contrast values of images acquired during a breath hold, could determine the cerebral blood flow using only their mind (e.g. by using their experience to associated the values with flow values). The claim recites an abstract idea. The claim recites no additional limitations which either integrate the abstract idea into a practical application or amount to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 43 recites an abstract idea without significantly more. The steps of calculating cerebral blood flow values and calculating a heart rate are directed at an abstract idea of a mental process. A user, looking at speckle contrast values of images acquired during a breath hold, could determine the cerebral blood flow and heart rate values using only their mind (e.g. by using their experience to associated the contrast values with flow values, and flow values with heart rate values). The claim recites an abstract idea. The claim recites no additional limitations which either integrate the abstract idea into a practical application or amount to significantly more than the judicial exception. The claim is not subject matter eligible.
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 39 and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. (Xu, Jian, et al. “Interferometric speckle visibility spectroscopy (ISVS) for human cerebral blood flow monitoring.” Apl Photonics 5.12 (2020).).
Regarding Claim 39, Xu discloses a method of determining one or more cerebral blood metrics (Abstract), the method comprising:
causing, using a laser (Pg. 4, Col 2, ¶ 3), light to be emitted into a brain within a skull of a head of a user (Fig. 1a)+(Fig. 3a) (Pg. 6, Col 1, ¶2);
obtaining, using a light detector (Fig. 3a, camera)+ (Pg. 6, Col 1, ¶2), information indicative of light reflected from one more structures within the brain (Pg. 6, Col 2, ¶1-2); and
based on the information indicative of light reflected from one more structures within the brain, determining one or more cerebral blood metrics as a function of time (Fig. 3e-i)+(Pg. 8, Col 1, ¶3).
Regarding Claim 41, Xu discloses the invention as claimed. Xu further teaches wherein the obtained information indicative of light reflected from one more structures within the brain comprises a plurality of speckle images (Pg. 3, Section Principal)+(Pg. 6, Col 2, ¶1).
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.
Claims 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Lee et al. (U.S PGPub 2014/0206980 A1) and Dunn et al. (U.S PGPub 2012/0095354 A1).
Regarding Claim 42, the combination of references teaches the invention substantially as claimed. Xu fails to explicitly teach normalizing each speckle image based on a first set of the plurality of speckle images acquired during a first time period; calculating a speckle contrast of each normalized speckle image; and adjusting the speckle contrast to account for noise.
Lee teaches a method for calculating blood flow from speckle images (Abstract). This system normalizes each speckle image based on a first set of the plurality of speckle images acquired during a first time period [0037]. The system then calculating a speckle contrast of each normalized speckle image [0037].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Xu to normalize the speckle images and calculate a speckle contrast, and taught by Lee, because this allows for the image to determine blood flow parameters in real time with reduced computational complexity, as recognized by Lee [0006].
The combination is silent regarding adjusting the speckle contrast to account for noise.
Dunn teaches a system for speckle laser contrast imaging (Abstract). This system adjusts the speckle contrast to account for the noise [0076]+[0092].
It would have been obvious to one of ordinary skill in the art before the effective filing date to adjust the speckle contrast to account for noise, as taught by Dunn, because this would increase the accuracy of the blood flow measurements, as recognized by Dunn [0005]+[0104].
Regarding Claim 43, the combination of references teaches the invention substantially as claimed. Xu further teaches further comprising calculating a cerebral blood flow from the adjusted speckle contrast adjusted for noise of each image of a second set of the plurality of speckle images acquired during a second time period in which the user was holding their breath (Fig. 3g) (Pg. 8, Col 1, ¶1-2).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Lee and Dunn as applied to claim 42 above, and further in view of Mizeva et al (Mizeva, Irina, et al. "Spatial heterogeneity of cutaneous blood flow respiratory-related oscillations quantified via laser speckle contrast imaging." PLoS One 16.5 (2021): e0252296.).
Regarding Claim 44, the combination of references teaches the invention substantially as claimed. Xu further teaches calculating a plurality of cerebral blood flow values over time from the adjusted speckle contrast adjusted for noise of a second set of the plurality of speckle images acquired during a second time period in which the user was holding their breath (Fig. 3g) (Pg. 8, Col 1, ¶1-2) and calculating a heart rate from a period in a plurality of cerebral blood flow values over time (Fig. 3e-3f) (Pg. 6, Col 2, ¶1).
Xu is silent the cerebral blood flow values used to calculate the heart rate are from when the user was holding their breath.
Mizeva teaches a system for using speckle images to analyze blood flow (Abstract). This system analyzes the heart rate calculated from the flow images acquired during a breath hold maneuver (Pg. 3, Physiological tests)+(Pg. 8-9, Breath Holding Test).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Xu to calculate the cardiac frequency (i.e. heart rate) during a breath hold, as taught by Mizeva, because this removes the affect of respiratory motion from the acquired data, thereby increasing the accuracy of the heart rate calculation, as suggested by Mizeva (Pg. 11, ¶ 4-5).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Guang et al. (CN115211830A), which teaches a method of determining cerebral blood flow using speckle imaging.
Dunn et al. (U.S PGPub 2012/0071769 A1), which teaches a method of producing laser contrast speckle images.
Dunn (Dunn, Andrew K. "Laser speckle contrast imaging of cerebral blood flow." Annals of biomedical engineering 40.2 (2012): 367-377.) which teaches a method of determining cerebral blood flow from speckle images.
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/SEAN D MATTSON/Primary Examiner, Art Unit 3798
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