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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/15/2026 has been entered.
Claim Objections
Claims 63-64 are objected to because of the following informalities: spelling. 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 20-28, 30-32, 49-26, and 58-60 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract idea of monitoring cerebral hemodynamics without significantly more. The claim(s) recite(s) the steps of providing laser light to brain tissue within a skull; using one or more sensors to detect a speckle pattern over an exposure time based on light passing through the brain tissue within the skull illuminated by the laser light; determining one or more speckle statistics from the speckle pattern of the image; repeating steps to determine speckle statistics for a plurality of exposure times; and monitoring cerebral hemodynamics of the brain tissue over time based on at least in part on the one or more speckle statistics. This judicial exception is not integrated into a practical application because the steps of merely recite the process of gathering and organizing data, and performing data analysis and evaluation, which can be performed as a mental step or on pen and paper. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed subject matter generally links the use of the judicial exception to a particular environment, performing well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality and perform the basic functions of light imaging (i.e., light source and sensors for receiving). The addition of a general purpose computer components alone to perform such steps is not sufficient to transform a judicial exception into a patentable invention. The computer components are recited at a high level of generality and perform the basic functions of a computer (in this case, performing statistical analysis). Merely using generic computer components to perform the above identified basic computer functions to practice or apply the judicial exception does not constitute a meaningful limitation that would amount to significantly more than the judicial exception.
Claims 21 and 23-32 are dependent on claim 20 and includes all the limitations of claim 20. Therefore, claims 21 and 23-32 recite the same abstract idea of monitoring cerebral hemodynamics. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed subject matter generally links the use of the judicial exception to a particular environment, performing well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality and recite the concept of performing mathematical calculations, data gathering/analysis, and evaluation.
Claim 22 are dependent on claim 20 and includes all the limitations of claim 20. Therefore, claim 22 recite the same abstract idea of monitoring cerebral hemodynamics. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the optical fibers are conventional elements previously known to the industry, specified at a high level of generality, in order to transmit and receive light.
Claims 50-60 are dependent on claim 49 and includes all the limitations of claim 49. Therefore, claims 50-60 recite the same abstract idea of monitoring cerebral hemodynamics. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed subject matter generally links the use of the judicial exception to a particular environment, performing well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality and recite the concept of performing mathematical calculations, data gathering/analysis, and evaluation.
Claims 61-62 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract idea of monitoring cerebral hemodynamics without significantly more. The claim(s) recite(s) the steps of a computer readable media comprising program instructions for causing, using a laser source, delivery of laser light to brain tissue within a skull; using at least one processor to determine one or more speckle statistics of a speckle pattern; and monitoring cerebral hemodynamics of the brain tissue based on at least in part on the one or more speckle statistics. This judicial exception is not integrated into a practical application because the steps of merely recite the process of gathering and organizing data, and performing data analysis and evaluation, which can be performed as a mental step or on pen and paper. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed subject matter generally links the use of the judicial exception to a particular environment, performing well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality and perform the basic functions of light imaging (i.e., light source and sensors for receiving). The addition of general purpose computer components to perform the abstract idea is not sufficient to transform it into a patentable invention. The computer components are recited at a high level of generality, and perform the basic functions of a computer that would be needed to apply the abstract idea via a computer.
Claim 62 is dependent on claim 61 and includes all the limitations of claim 61. Therefore, claim 62 recites the same abstract idea of monitoring cerebral hemodynamics. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed subject matter generally links the use of the judicial exception to a particular environment, performing well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality and recite the concept of performing mathematical calculations, data gathering/analysis, and evaluation.
Claim Rejections - 35 USC § 102
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.
Claim(s) 20-21, 23-26, 33, 35-37, 39, 49-54, 58, and 61-62 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dunn et al. (US 2012/0095354).
With respect to claims 20 and 49, Dunn et al. discloses a method for monitoring cerebral hemodynamics, the method comprising: providing a laser light to a skull ([0008]; [0090]); recording an image with a speckle pattern over an exposure time based on light passing through brain tissue within the skull ([0008]; [0091]); determining one or more speckle statistics of the image ([0008]; [0098]); repeating to determine speckle statistics for a plurality of exposure times ([0091]); and monitoring cerebral hemodynamics of the brain tissue based at least in part on the one or more speckle statistics ([0008]; [0100]).
With respect to claims 21 and 50, Dunn et al. discloses wherein the one or more speckle statistics comprise a speckle contrast ([0043]; [0045]) and/or an average value of the speckle pattern ([0075]).
With respect to claims 23 and 51, Dunn et al. discloses determining a speckle contrast for the image; and calculating at least one decorrelation time based on the speckle contrast ([0046]).
With respect to claims 24 and 52, Dunn et al. discloses wherein the cerebral hemodynamics of the brain tissue is determined based at least in part on the at least one decorrelation time ([0046-0047]).
With respect to claims 25 and 53, Dunn et al. discloses wherein the speckle contrast is determined based at least in part on a mean intensity and a standard deviation of the image ([0077]).
With respect to claims 26 and 54, Dunn et al. discloses wherein the cerebral hemodynamics comprises cerebral blood flow in the brain tissue ([0003]; [0005]; [0094]).
With respect to claim 33, Dunn et al. discloses a system for monitoring cerebral hemodynamics, the system comprising: one or more optical systems configured to provide laser light to a skull and collect light pass through brain tissue being imaged within the skull ([0007-0008]; [0043]); and one or more sensors configured to record one or more images based on the light passing through the brain tissue ([0007-0008]; [0043]), wherein each image comprises a speckle pattern recorded over an exposure time ([0008]; [0043]).
With respect to claim 35, Dunn et al. discloses wherein the one or more speckle statistics comprise a speckle contrast ([0043]; [0045]) and/or an average value of the speckle pattern ([0075]).
With respect to claim 36, Dunn et al. discloses determining hemodynamics of the brain tissue is determined based at least in part on the at least one decorrelation time ([0046-0047]).
With respect to claim 37, Dunn et al. discloses determining based at least in part on a mean intensity and a standard deviation of the image ([0077]).
With respect to claim 39, Dunn et al. discloses one or more processors ([0007-0008]; [0063]).
With respect to claim 57, Dunn et al. discloses a plurality of images recorded over different exposure times ([0047]).
With respect to claim 58, Dunn et al. discloses determining a change of blood flow ([0032]).
With respect to claim 61, Dunn et al. discloses a non-transitory computer readable media comprising executable instructions ([0063]).
With respect to claim 62, Dunn et al. discloses wherein the one or more speckle statistics comprise a speckle contrast ([0043]; [0045]) and/or an average value of the speckle pattern ([0075]).
Claim(s) 20, 22-24, 26-28, 33, 36, 39-42, 47, 49, 51-52, and 54-56 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (US 10,016,137).
With respect to claims 20 and 49, Yang et al. discloses a method for monitoring cerebral hemodynamics, the method comprising: providing a laser light to a skull (col. 4, line 66 to col. 5, line 8; col. 12, lines 27-50); recording an image with a speckle pattern over an exposure time based on light passing through brain tissue within the skull (col. 10, lines 36-54); determining one or more speckle statistics of the image (col. 7, line 64 to col. 8, line 3; col. 14, line 9-27); repeating to determine speckle statistics for a plurality of exposure times (col. 14, lines 21-27; col. 33, lines 31-34); and monitoring cerebral hemodynamics of the brain tissue over time based at least in part on the one or more speckle statistics (col. 11, lines 9-29; col. 30, lines 9-34).
With respect to claim 22, Yang et al. discloses one or more optical fibers (col. 21, lines 40-67)
With respect to claims 23-24 and 51-52, Yang et al. discloses calculating decorrelation time (col. 19, lines 37-67).
With respect to claims 26-28 and 54-56, Yang et al. discloses determining brain activity (col. 29, lines 3-28; col. 37, lines 36-55).
With respect to claim 33, Yang et al. discloses a system for monitoring cerebral hemodynamics, the system comprising: one or more optical systems configured to provide laser light to a skull and collect light passing through brain tissue being imaged within the skull (col. 12, lines 27-50); and one or more sensors configured to record one or more images based on the light passing through the brain, wherein each image comprises a speckle pattern recorded over an exposure time (col. 3, lines 6-27; col. 27, lines 16-25; col. 40, lines 7-9).
With respect to claim 36, Yang et al. discloses calculating decorrelation time (col. 19, lines 37-67).
With respect to claim 39, Yang et al. discloses one or more processors (col. 6, lines 1-22).
With respect to claims 40-41, Yang et al. discloses one or more optical fibers (col. 21, lines 40-67)
With respect to claim 42, Yang et al. discloses wavelength between about 650 nm and 950 nm (col. 14, lines 9-17).
With respect to claim 47, Yang et al. disclose wherein one or more optical systems comprises an aperture (col. 17, lines 36-51).
Claim(s) 64 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levi et al. (US 8,306,607).
Levi et al. discloses a system comprising one or more optical systems configured to provide laser light to a skull and collect light passing through brain tissue being imaged within the skull (100; col. 8, lines 2-8); one or more sensors configured to record one or more images based on light passing through brain tissue, wherein each speckle pattern is recorded over an exposure time (col. 8, lines 9-17); wherein the one or more optical systems are in optical communication with at least one laser having a laser power of 11 mW, 0.5 mW, 0.26 mW, 0.13 mW, 0.06 mW, or 0.03 mW (col. 9, lines 15-17).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 21, 25, 35, 37, 50, 53, 58, and 61-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 10,016,137) in view of Dunn et al. (US 2012/0095354).
With respect to claims 21, 25, 35, 37, 50, and 53, Yang et al. discloses the subject matter substantially as claimed except for a mean intensity and a standard deviation. However, Dunn et al. teaches in the same field of endeavor determining a mean and standard deviation is well known in the art to estimate speckle contrast ([0077]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Yang et al. with determining a mean and standard deviation a to estimate speckle contrast is well known to one of ordinary skill in the art ([0077]).
With respect to claim 58, Yang et al. discloses the subject matter substantially as claimed except for determining change of cerebral blood flow of at least two images. However, Dunn et al. teaches in the same field of endeavor determining a change of blood flow ([0003]; [0032]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Yang et al. with determining blood flow changes as taught by Dunn et al. in order to quantify blood flow changes in stroke models and for functional activation studies ([0003]).
With respect to claim 61, Yang et al. discloses the subject matter substantially as claimed except for a computer readable medium comprising program instructions for performing the method. However, Dunn et al. discloses in the same field of endeavor it is well known for non-transitory computer readable media comprising executable instructions to perform the method ([0063]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided a storage media as taught by Dunn et al. in order to store instructions for the processor to execute the method ([0063]).
With respect to claim 62, Dunn et al. discloses wherein the one or more speckle statistics comprise a speckle contrast ([0043]; [0045]) and/or an average value of the speckle pattern ([0075]).
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 10,016,137) in view of Thankor et al. (US 9,155,480).
Yang et al. discloses the subject matter substantially as claimed except for at least one CMOS sensor. However, Thankor et al. teaches in the same field of endeavor using CMOS (col. 3, lines 29-32). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Yang et al. with a CMOS as taught by Thankor et al. as a substitution of one detector for another is well within the skill level of one of ordinary skill in the art.
Claim(s) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 10,016,137) in view of Yao et al. (US 11,013,414).
Yang et al. discloses the subject matter substantially as claimed except for a frame rate of about 100 Hz. However, Yao et al. teaches in the same field of endeavor a camera with a frame rate between 60Hz to 1000 Hz (col. 17, lines 47-59). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Yang et al. with a frame rate of about 100 Hz as taught by Yao et al. as an optimization of ranges is well within the skill level of one of ordinary skill in the art (MPEP 2144.05).
Claim(s) 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tunnell et al. (US 2017/0224220) in view of Marchitto et al. (US 2001/0050083).
Tunnell et al. discloses a system comprising one or more optical systems configured to provide laser light to a skull and collect light passing through brain tissue ([0003]; [0008]); one or more sensors configured to record one or more images based on light passing through brain tissue, wherein each speckle pattern is recorded over an exposure time ([0003]; [0054]); wherein the laser light is collimated 56 mW laser ([0025]). Tunnell et al. discloses the subject matter substantially as claimed except for a 6 mm spot size. However, Marchitto et al. teaches in the same field of endeavor wherein laser is focused and collimated to produce a spot size of 5 mm. ([0176]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Tunnell et al. with a focused and collimated spot size as taught by Marchitto et al. as it is well known to focus and collimate a laser to produce a spot and a change in size is within the skill level of one of ordinary skill in the art (MPEP 2144.04(IV)(A)).
Response to Arguments
Applicant's arguments filed 5/15/2026 have been fully considered but they are not persuasive.
Applicant argues the use of a laser light and use of a sensor have been considered but they are not persuasive. The Examiner’s position is that the use of the laser and sensor are routine and conventional activities previously known to the industry, specified at a high level of generality and perform the basic functions of light imaging (i.e., light source and sensors for receiving). These steps are related to the concept of gathering and receiving data, which are necessary in order to acquire the data for further evaluation. Merely using generic components to perform the above identified basic functions to practice or apply the judicial exception does not constitute a meaningful limitation that would amount to significantly more than the judicial exception. Applicant argues that the steps cannot be performed in the human mind as they require highly intensive computations and/or comprise a huge volume of repetitions. However, the Examiner' s position is that the claims merely recite steps at a high level of generality and fail to set forth specific algorithms or calculations that are sufficient to amount to significantly more than the judicial exception. The Examiner notes that performing repetitive calculations are considered as well-understood, routine, and conventional functions when they are claimed in a merely generic manner or as insignificant extra-solution activity (MPEP 2106.05(d)(II)).
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant argues the reference does not teach “for a plurality of exposure times”. However, the Examiner respectfully disagrees with the applicant. Dunn et al. discloses a plurality of exposure times ([0091]; [0103]; [0105-0106]; Figs. 13A-13B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER LUONG whose telephone number is (571)270-1609. The examiner can normally be reached M-F 9-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan T Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER LUONG/Primary Examiner, Art Unit 3797
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