DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This action is in response to the remarks filed on 07/21/2025.
The amendments filed on 07/21/2025 have been entered. Accordingly claims 1-20 remain pending. Claims 1, 10, 11, 19, and 20 are presently amended.
The previous objections to the claims have been withdrawn in light of applicant's amendments however the objection relating to the “first location” has not been addressed and is therefore maintained.
Response to Arguments
Applicant's arguments filed 07/21/2025 regarding the 35 U.S.C. 112(b) rejections relating to the limitation “at a first time point” of claims 1, 11, and 20 have been fully considered but they are not persuasive. Although the amendments have addressed some of the previously raised issues of indefiniteness not all of the issues have been addressed.
Specifically, the limitation “a first time point” in line 4 renders the claim indefinite because it is unclear whether this is the same as or different from the first time point recited in line 2 of the claim.
Applicant's arguments regarding the 35 U.S.C. 101 rejection of the claims have been fully considered but they are not persuasive.
In particular, applicant argues on page 7 of the arguments, that measuring optical density is essential to performing the subsequent operations recited in claim 1 and therefore allegedly cannot be considered an extra-solution activity. Examiner respectfully disagrees. Per MPEP 2106.05(g) “extra-solution activity includes both pre-solution and post-solution activity. An example of pre-solution activity is a step of gathering data for use in a claimed process”.
Applicant further argues on page 8 of the arguments that measuring optical density is neither an abstract idea nor merely a mathematical calculation. Examiner notes that measuring optical density has not been indicated as an abstract idea in the rejection.
Applicant also argues that the abstract ideas of claim 1 are integrated into a practical application of displaying a metric indicating an urgency of performing a treatment for intracranial hemorrhage. However this limitation does not integrate the judicial exception into a practical application because it merely adds insignificant extra-solution activity, in particular insignificant application.
Applicant's arguments regarding the 35 U.S.C. 103 rejection of the claims have been fully considered but they are not persuasive. Specifically, applicant argues that L-H does not disclose eliminating a predetermined number of largest absolute DOD values because the outliers in L-H are specific to the dataset and may vary for a given dataset depending on how the amplitude envelope is determined. This is not persuasive because the claim does not require the number to be fixed, rather just predetermined. As mentioned by applicant, L-H teaches prior to removal determination of the amplitude envelope which determines the number of outliers in the dataset is done prior, i.e., predetermined, to the removal as mentioned in e.g., paragraph [0010] of L-H. Applicant further argues that one of ordinary skill in the art would not have found it obvious to modify the teachings of Ben Dor based on the teachings of L-H because some parts of the dataset of L-H do not have particular relevance. This is not persuasive. L-H was merely relied on to teach the elimination of certain data points. As previously stated, modifying Ben Dor with the teachings of L-H would improve the accuracy and reliability of the analysis of the data.
Claim Objections
Claims 1, 11, and 20 are objected to because of the following informalities:
Regarding claims 1, 11, and 20, the limitation “first location” should be changed to –a first location”.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Analysis step 1 of Subject Matter Eligibility Test
The claims are directed to a process (i.e., a method of assessing intracranial hemorrhage in a subject) of claims 1-10, a manufacture (i.e., a non-transitory machine-readable medium storing instructions to cause one or more processors to perform operations) of claims 11-19, and a machine (i.e., a system) of claim 20.
Analysis step 2A, Prong I
The claims recite abstract ideas, in particular, mathematical concepts.
Claim 1 recites “(a) at a first time point [...] (ab) computing a set of values of a change (DOD) in optical density by subtracting each OD value measured on the first side from each of the OD values measured on the second side [...] (ad) computing a first average DOD value by averaging remaining of DOD values from among the set of DOD values after step (ac); (b) at second time point, repeating steps (aa)-(ad) obtain a second average DOD value ; and (c) determining a progression of intracranial hemorrhage based on a difference between the first average DOD and the second average DOD” which are mathematical calculations. Independent claims 11 and 20 recite analogous limitations. Dependent claims 2-3, 5-6, 8, 12-13, 15, and 17. merely further limit the steps of the independent claims that are mathematical calculations. Steps (d) and (f) of dependent claim 19 recite mathematical calculations and further limit the steps of independent claim 11 that are mathematical calculations.
Analysis step 2A, Prong II
The judicial exception is not integrated into a practical application because the additional elements of the claim merely add insignificant extra-solution activity to the judicial exception and are mere instructions to implement an abstract ideas on a computer. See MPEP 2106.05 (f) and (g).
Claim 1 recites “(aa) measuring, for a plurality of times, optical density (OD) value at first location on a first side of a head of the subject at a first time point, and a first corresponding location on a second side of the head of the subject” which is insignificant extra-solution activity, in particular mere data gathering. Independent claims 11 and 20 recite analogous limitations, including the “optical probe configured to measure optical density from a portion of a subject's head” in claim 20. Dependent claims 4, 9, 14, and 18 merely further limit the measurement limitation.
Claim 1 also recites “(ac) eliminating a predetermined number of largest absolute DOD values from the set of DOD values” which is insignificant extra-solution activity, in particular selecting a particular data source or type of data to be manipulated. Independent claims 11 and 20 recite an analogous limitation.
Claim 1 also recites “(c1) in response to a determination that the intracranial hemorrhage has progressed, displaying on a graphical user interface of a near-infrared spectroscopy apparatus a metric indicating an urgency of performing a treatment for intracranial hemorrhage” which is insignificant extra-solution activity, in particular insignificant application. Independent claims 11 and 20 recite an analogous limitation.
Independent claim 20 recites “a graphical interface”, “a memory device to store instructions” and “one or more processors operably coupled to the optical probe and configured to execute the instructions stored on the memory device”. These additional elements result in mere instructions to implement an abstract idea on a computer.
Dependent claim 7 recites “storing the difference between the first average DOD and the second average DOD obtained in step (c) for each of the plurality of time points in a non-transitory memory” which is insignificant extra-solution activity, in particular insignificant application. Dependent claim 16 recites an analogous limitation. Dependent claim 19 recites “(f) providing a graphical display of the location of the intracranial hemorrhage” which is insignificant extra-solution activity, in particular insignificant application.
Analysis step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the graphical interface, memory, and processors are additional elements that merely result in instructions to implement an abstract idea on a computer that is well-understood, routine, and conventional activity previously known to the industry. The remaining additional elements merely add insignificant extra-solution activity to the judicial exception that are well-understood, routine, and conventional activities previously known to the industry.
Claims 1-20 are therefore directed to a judicial exception without significantly more. The claims are not patent eligible.
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.
Claim 1-20 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.
Regarding claim 1, the limitation “a first time point” in line 4 renders the claim indefinite because it is unclear whether this is the same as or different from the first time point recited in line 2 of the claim. For the present purposes of examination, they have been interpreted as being the same. Further clarification is required. Independent claims 11 and 20 recite analogous limitations.
Regarding claim 3, the limitation “performed at least three times at each of the first and second time points” renders the claim indefinite. It is unclear whether the limitation “at least three times” specifically limits the recitation of “a plurality of times” recited in claim 1. For the present purposes of examination, the limitation has been interpreted as the plurality of times being limited to at least three times. Further clarification is required. This also applies to the analogous limitation of claim 13.
Regarding claim 20, it is unclear whether the “graphical interface” in line 3 is the same as or different than the “graphical user interface” in the penultimate line of the claim. For the present purposes of examination, they have been interpreted as being the same. Further clarification is required.
Claims dependent upon a claim rejected under 35 U.S.C. 112(b) are also rejected under the same statute because they each inherit the indefiniteness of the claim(s) they respectively depend upon.
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.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ben Dor et al. (US 2009/0221919) in view of Izzetoglu et al. (US 2016/0310054), Linkenkaer-Hansen et al. (US 2021/0000367, hereinafter “L-H”), and Halperin et al. (US 2008/0269625, October 30, 2008).
Regarding claims 1, 11, and 20, as best understood in light of the 35 U.S.C. 112(b) rejection stated above, Ben Dor discloses a method (and corresponding non-transitory machine-readable medium and system) of assessing intracranial hemorrhage in a subject (“A system and method for determining brain hematoma including a handheld device for emitting and detecting radiation with a removable light guide assembly. A method for determining a brain hematoma condition that includes determining optical density of various regions of the brain using near infrared spectroscopy.” Abstract; also see [0068]), the method comprising:
(aa) measuring, for a plurality of times (“re-measure at the same head locations” [0159]; also see Figs. 7B-D and corresponding descriptions), an optical density (OD) value at first location on a first side of a head of the subject at a first time point, and a first corresponding location on a second side of the head of the subject (“an NIRS probe is placed successively in the left and right frontal, temporal, parietal, and occipital areas of the head and the absorbance of light at one or more selected wavelengths is recorded. In another embodiment, an NIRS probe is used to record data regarding the regions of one side of the head (e.g., frontal, temporal, parietal, and occipital) and then on the other side of the head.” [0058]),
(ab) computing a set of values of a change in optical density (DOD) by subtracting each OD value measured on the first side from each of the OD values measured on the second side (“In one embodiment .DELTA.OD is measured between contralateral head locations, i.e., Right Frontal v. Left Frontal, Right Temporal v. Left Temporal, Right Occipital v. Left Occipital and Right Parietal v. Left Parietal). In one embodiment, probe 120 is placed in a substantially identical location on opposing sides of patient's head (i.e., a symmetric placement) for a particular contralateral pair.” [0124]),
(ad) computing a first average DOD value by averaging the set of values DOD (“data values are averaged for purposes of evaluating the validity of data. Also in one embodiment, the average value is presented to the user at step 820” [0156]).
Although Ben Dor discloses determining intracranial hemorrhage by the claimed limitations stated above, Ben Dor fails to disclose repeating the claimed limitations at two time points to determine progression of intracranial hemorrhage by comparison of the two time points, i.e., (a) beginning at a first time point; (b) beginning at a second time point, repeating steps(aa)-(ad) obtain a second average DOD value; and (c) determining a progression of intracranial hemorrhage based on a difference between the first average DOD and the second average DOD.
However, Izzetoglu teaches, in the same field of endeavor, determining a progression of cerebral edema by comparison of measurements and evaluations at two time points (“A system, device and methods for quantitatively monitoring and evaluating changes in water and hemoglobin content in the brain” Abstract; also see “changes in concentrations of water, oxyHb and deoxyHb due to edema can be reliably measured even in the presence of hemorrhage or hematoma which can occur simultaneously with edema or regardless of changes in the blood content due decrease in cerebral blood flow (CBF) or increased cerebral blood volume which are very common consequences of traumatic brain injury. Thus, the embodiment disclosed herein monitors both the hemoglobin and water contents in the brain.” [0074]; also see “the reference standard is obtained the same subject undergoing testing and comprises the NIRS data from an earlier timepoint in testing” [0097]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Ben Dor with (a) beginning at a first time point; (b) beginning at a second time point, repeating steps(aa)-(ad) obtain a second average DOD value; and (c) determining a progression of intracranial hemorrhage based on a difference between the first average DOD and the second average DOD as taught by Izzetoglu in order to monitor the effectiveness of therapeutic intervention ([0056] of Izzetoglu).
Although Ben Dor discloses averaging DOD values as stated above, Ben Dor fails to disclose (ac) eliminating a predetermined number of largest absolute DOD values from the set of values of the DOD, and (ad) computing a first average DOD value by averaging remaining of DOD values from among the set of values of DOD after step (ac).
However, L-H teaches, in the same field of endeavor, eliminating a predetermined number of largest absolute values from a dataset before computing an average value (“ a mean or median amplitude or amplitude envelope is calculated for values assigned to a particular timeslot in step 220. Depending on the application, either operation—mean or median—may be calculated. In further examples, outliers may be removed from a dataset before calculating the mean or median value. Alternatively or additionally the mean or median of the power or power envelope may be calculated per timeslot” [0060]; also see [0057]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Ben Dor with ((ac) eliminating a predetermined number of largest absolute DOD values from the set of values of the DOD, and (ad) computing a first average DOD value by averaging remaining of DOD values from among the set of values of DOD after step (ac) as taught by L-H in order to improve the accuracy and reliability of the analysis of the data.
Specifically with respect to independent claim 20, Ben Dor further discloses an optical probe (“a handheld probe having a source of infrared light” [0012]) configured to measure optical density from a portion of a subject's head (“determining optical density of various regions of the brain using near infrared spectroscopy” Abstract); a graphical interface (“user interface 145 (e.g., a graphical user interface (GUI))” [0068]) a memory device to store instructions (“memory” [0067], [0068]); one or more processors operably coupled to the optical probe and configured to execute the instructions stored on the memory device (“processor” [0068]).
Although Ben Dor discloses in response to detection of the intracranial hemorrhage (“it might be desirable to more specifically locate the hematoma so, for example, treatment such as draining the hematoma can begin immediately in the field upon diagnosis” [0158]), displaying on a graphical user interface of a near-infrared spectroscopy apparatus (“user interface 145 (e.g., a graphical user interface (GUI))” [0068]) a metric indicating an urgency of performing a treatment for intracranial hemorrhage (“For example, contour map 860 shows regions of varying optical density along with a graphical display of the optical density in the corresponding region. In one embodiment, both a tabular (e.g., table 850) and graphical representation 860 are displayed for the user. In one embodiment, at step 834 multiple data is compared to identify whether the maximal optical density has been achieved whereupon treatment of the hematoma may be initiated.” [0158]), Ben Dor fails to explicitly disclose (c1) in response to a determination that the intracranial hemorrhage has progressed, displaying on a graphical user interface of a near-infrared spectroscopy apparatus a metric indicating an urgency of performing a treatment for intracranial hemorrhage.
However, Halperin teaches, in the same field of endeavor, in response to a determination that a condition has progressed, displaying on a graphical user interface (“an output device presenting the result on a numerical, textual or graphical display, or transmitting the results to a clinical follow-up center.” [0222]) a metric indicating an urgency of performing a treatment for the condition (“a method is provided for generating an early warning of an impending clinical worsening of the heart condition, upon early buildup of lung fluid, thereby facilitating treatment before the clinical symptoms become more severe” [0114]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Ben Dor with (c1) in response to a determination that the intracranial hemorrhage has progressed, displaying on a graphical user interface of a near-infrared spectroscopy apparatus a metric indicating an urgency of performing a treatment for intracranial hemorrhage as taught by Halperin in order to facilitate timely treatment ([0114] of Halperin).
Regarding claims 2 and 12, Ben Dor modified by Izzetoglu, L-H, and Halperin discloses the limitations of claims 1 and 11, respectively, as stated above, in particular L-H was relied on to teach step (ac). Ben Dor modified by L-H is silent on wherein the predetermined number in step (ac) is in a range from 3 to 6. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a range from 3 to 6 because doing so would ensure adequate removal of outliers to improve the accuracy and reliability of the analysis of the data. Applicant has not disclosed criticality in the specification for the range from 3 to 6 or that the range provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05(II)(A).
Regarding claims 3 and 13, Ben Dor modified by Izzetoglu, L-H, and Halperin discloses the limitations of claims 1 and 11, respectively, as stated above. As best understood in light of the 35 U.S.C. 112(b) rejection stated above, Ben Dor is silent on wherein steps (aa)-(ad) are performed at least three times at each of the first and second time points. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to repeat the steps at least three times because doing so would provide a more complete analysis over time. Applicant has not disclosed criticality in the specification for repeating the steps at least three times or that at least three times provides an unexpected advantage, is used for a particular purpose, or solves a stated problem. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05(II)(A).
Regarding claims 4 and 14, Ben Dor further discloses wherein the OD values in step (aa) are measured at one or more near- infrared wavelengths (“determining optical density of various regions of the brain using near infrared spectroscopy” Abstract; also see [0071]).
Regarding claim 5, Ben Dor further discloses repeating steps (a)-(c) at a second location on the first side and a second corresponding location on the second side of the head of the subject (“DELTA.OD is measured between contralateral head locations, i.e., Right Frontal v. Left Frontal, Right Temporal v. Left Temporal, Right Occipital v. Left Occipital and Right Parietal v. Left Parietal).” [0124]).
Regarding claims 6 and 15, Ben Dor modified by Izzetoglu, L-H, and Halperin discloses the limitations of claims 1 and 11, respectively, as stated above and Ben Dor further discloses wherein the second time point comprises a plurality of time points (“re-measure at the same head locations” [0159]; also see Figs. 7B-D and corresponding descriptions).
Regarding claims 7 and 16, Ben Dor modified by Izzetoglu, L-H, and Halperin discloses the limitations of claims 6 and 15, respectively, as stated above and Ben Dor further discloses storing the difference between the first average AOD and the second average AOD obtained in step (c) for each of the plurality of time points in a non-transitory memory (“all data collection, storage and measurement commands are performed within probe 120. In one embodiment, processor 140 displays and stores data as commanded by probe 120” [0149]; also see “memory” in [0067], [0068], [0146]).
Regarding claims 8 and 17, Ben Dor modified by Izzetoglu, L-H, and Halperin discloses the limitations of claims 1 and 11, respectively, as stated above, in particular Izzetoglu was relied on to teach the difference obtained in step (c). Izzetoglu further teaches, in the same field of endeavor, wherein an increase in absolute value of the difference obtained at step (c) is indicative of an increase in intensity of the intracranial hemorrhage (“Based on this evaluation and the relative changes in the subject's NIR data for oxyHb, deoxyHb and water compared to one or multiple reference standards, the physician can identify the occurrence of a hypoxic event or injury or disease in the subject by identifying a characteristic decrease in the NIR values occasioned by hypoxic injury. The same method is useful for monitoring and adjusting therapy for a subject recovering or under treatment for such a hypoxic injury.” [0099]; also see [0106]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Ben Dor with wherein an increase in absolute value of the difference obtained at step (c) is indicative of an increase in intensity of the intracranial hemorrhage as taught by Izzetoglu in order to monitor the effectiveness of therapeutic intervention ([0056] of Izzetoglu).
Regarding claims 9 and 18, Ben Dor further discloses wherein measuring the optical density value comprises applying an optical probe to the head of the subject (“an NIRS probe is placed successively in the left and right frontal, temporal, parietal, and occipital areas of the head and the absorbance of light at one or more selected wavelengths is recorded” [0058]).
Regarding claims 10 and 19, Ben Dor further discloses (d) repeating steps (a)-(c) at a plurality of locations on the first side of the head of the subject and corresponding plurality of locations on the second side of the head of the subject (“The user may then move probe 120 to a nearby location (step 836) still corresponding to the region of interest (e.g., the left temporal lobe) and take another optical density measurement. In one embodiment, that nearby location is preselected. In another location that nearby location is selected by the user in the field. In this fashion, the user may create a contour map illustrating the optical densities throughout a particular region of the brain (e.g., the left temporal lobe).” [0158]; also see Fig. 8A and corresponding description); (e) determining a location of the intracranial hemorrhage based on an average DOD value at each of the plurality of locations on the first side and the corresponding plurality of locations on the second side (“locate the hematoma so, for example, treatment such as draining the hematoma can begin immediately in the field upon diagnosis. In one embodiment, illustrated in FIG. 8C, it is desirable to create a contour profile of the hematoma to more precisely locate the hematoma within a particular lobe [...] multiple data is compared to identify whether the maximal optical density has been achieved whereupon treatment of the hematoma may be initiated. In another embodiment, table 850 displays the current measurement and the maximum measurement to facilitate diagnosis by the user. In one embodiment, software in processor 140 graphically interprets optical density measurements to create contour map 860 which also identifies the specific location of the hematoma” [0158]); and (f) providing, on the graphical user interface (“user interface 145 (e.g., a graphical user interface (GUI))” [0068]), a graphical location of the intracranial hemorrhage (“graphically interprets optical density measurements to create contour map 860 which also identifies the specific location of the hematoma. In one embodiment, processor 140 is configured to display both the presence of brain hematoma and the local oxygen saturation in the measured sites.” [0158]; also see Fig. 8C and corresponding description).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMINAH ASGHAR whose telephone number is (571)272-0527. The examiner can normally be reached M-W, F 9am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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