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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1 – 15 in the reply filed on 11 MAY 2026 is acknowledged. Claims 16 – 31 and 50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11 MAY 2026.
Information Disclosure Statement
The listing of references at [0102], [0165], and [0170] in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The abstract of the disclosure is objected to because the first sentence uses implied phrasing of “is provided”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
Claim 7 is objected to because of the following informalities: The expanded form of “HbD” is not defined in the claim set. For the first recitation of “HbD” in the claims (Claim 7), an accompanying expanded form of the abbreviation is necessary. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: The expanded form of “THb” and “rTHb” are not defined in the claim set. For the first recitation of “THb” and “rTHb” in the claims (Claim 10), an accompanying expanded form of the abbreviations are necessary. 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:
“blood pressure sensing device” in claim 1 (and its dependent claims) to “continuously measure”
The claim limitation is interpreted according to [0099] with “The blood pressure sensing device 22 (“BP sensing device 22”) may be any sensor or device configured to continuously determine a subject's blood pressure (e.g., arterial blood pressure)” including “arterial catheter line”, “continuous non-invasive blood pressure device” or “pulse oximetry sensor”. The blood pressure sensing device is shown as generic block element “blood pressure sensing device 22” in Figs. 4A and 4B.
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.
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 1 – 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the term “a subject” in line 2. It is unclear if this is intended to be the same or different than the previously-recited subject of the preamble. For the purposes of examination, the term “a subject” is deemed to claim “the subject”. Claims 2 – 15 are similarly rejected due to their dependence on Claim 1.
Claim 1 recites the term “the blood pressure” in lines 6 – 7. It is unclear if this is intended to be the same or different than the previously-recited blood pressure level. For the purposes of examination, the term “the blood pressure” is deemed to claim “the blood pressure level”. Claims 2 – 15 are similarly rejected due to their dependence on Claim 1.
Claim 1 recites the term “an autoregulation function state of the subject” in lines 11 – 12. It is unclear if this is intended to be the same or different than the subject’s autoregulation state recited in the preamble. For the purposes of examination, the term “an autoregulation function state of the subject” is deemed to claim “the autoregulation function state of the subject.” Claims 2 – 15 are similarly rejected due to their dependence on Claim 1.
Claim 2 (line 1), Claim 3 (line 1), Claim 4 (line 4), Claim 5 (line 1), Claim 6 (line 1), Claim 8 (line 1), Claim 11 (line 1), and Claim 14 (line 1) each recite “wherein the step of determining”. There is no previously-recited named “step”. For the purposes of examination, the term “wherein the step of determining” is deemed to claim “wherein determining.” Claim 3, Claim 5, and Claim 15 are similarly rejected due to their dependence on Claim 2, Claim 4, and Claim 14, respectively.
Claim 2 recites the limitation “affected the measured blood pressure level of the subject”. Since the blood pressure level in Claim 1 is “continuously” measured, it is unclear if the “measured blood pressure level” is intended to be the same or different than the blood pressure level of the subject (as in all or part of this measurement data). For the purpose of examination, the term “affected the measured blood pressure level of the subject” is deemed to claim “affected the blood pressure level of the subject”.
Claim 9 (lines 3 and 4) and Claim 11 (line 3 and line 4) each recites the terms “a first subset of first signals” and “a second subset of first signals”. It is unclear if these first signals are intended to be the same or different than the previously-recited first signals. For the purposes of examination, the terms “a first subset of first signals” and “a second subset of first signals” are deemed to claim “a first subset of the first signals” and “a second subset of the first signals”. Claim 10 is similarly rejected due to its dependence on Claim 9.
Claim 10 recites the limitation “StO2, THb, rTHb, differential changes in oxyhemoglobin (O2Hb) and deoxyhemoglobin (HHb), or HbD.” It is unclear if these are intended to be the same as the previously-recited terms of these names. For the purpose of examination, the limitation “StO2, THb, rTHb, differential changes in oxyhemoglobin (O2Hb) and deoxyhemoglobin (HHb), or HbD” Is deemed to claim “the StO2, the THb, the rTHb, the differential changes in oxyhemoglobin (O2Hb) and the deoxyhemoglobin (HHb), or the HbD.
Claim 13 recites the limitation “the tissue being continuously sensed” in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is intended to be the same or different than the previously-recited tissue region. For the purposes of examination, the term “the tissue being continuously sensed” is deemed to claim “the tissue region of the subject being continuously sensed.” Claims 14 and 15 are similarly rejected due to their dependence on Claim 13.
Claim 15 recites the limitation “wherein the step of continuously sensing” in line 1. There is no previously-recited named “step”. For the purposes of examination, the term “wherein the step of continuously sensing” is deemed to claim “wherein continuously sensing”.
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 – 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 1, the claim recites "an act or step, or series of acts or steps" and is therefore a process, which is a statutory category of invention (Step 1). The claims are then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Each of Claims 1 – 15 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1 – 15 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 1 – 15 recites an abstract idea.
Specifically, Independent Claim 1 recites (underlined are observations, judgements, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim
A method for determining a subject's autoregulation function state, comprising:
continuously sensing a tissue region of a subject with a tissue oximeter, the sensing producing first signals representative of at least one tissue oxygenation parameter during a period of time;
continuously measuring a blood pressure level of the subject using a blood pressure sensing device during the period of time, the measuring producing second signals representative of the blood pressure of the subject during the period of time;
determining a presence or an absence of a confounding factor that affects the sensed at least one tissue oxygenation parameter in a manner independent of an autoregulation function of the subject, the determination using the first signals; and
using the first signals and the second signals to determine an autoregulation function state of the subject when the absence of the confounding factor is determined.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claim 1, these limitations include:
Observation and judgment of a presence or an absence of a confounding factor that affects the sensed at least one tissue oxygenation parameter in a manner independent of an autoregulation function of the subject, the determination using the first signals
Observation and judgment of the first signals and the second signals to determine an autoregulation function state of the subject when the absence of the confounding factor is determined.
Similarly, Dependent Claims 2 – 15 include the following abstract limitations, in addition to the aforementioned limitations in Independent Claim 1 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
determining whether the confounding factor has affected the measured blood pressure level of the subject in a manner independent of the autoregulation function of the subject using the second signals.
Observation and judgment of whether the confounding factor has affected the measured blood pressure level of the subject in a manner independent of the autoregulation function of the subject using the second signals.
determining said presence or said absence of the confounding factor utilizes a tissue oxygenation parameter trend data based on the first signals, and a blood pressure level trend data based on the second signals.
Observation and judgment of whether said presence or said absence of the confounding factor utilizes a tissue oxygenation parameter trend data based on the first signals, and a blood pressure level trend data based on the second signals.
determining a heart rate of the subject during the period of time, and producing third signals representative of the subject's heart rate during the period of time;
Observation and judgment of a heart rate of the subject during the period of time, and producing third signals representative of the subject's heart rate during the period of time;
determining whether the confounding factor has affected the heart rate of the subject in a manner independent of the autoregulation function of the subject using the third signals.
Observation and judgment of whether the confounding factor has affected the heart rate of the subject in a manner independent of the autoregulation function of the subject using the third signals.
the step of determining said presence or said absence of the confounding factor utilizes a tissue oxygenation parameter trend data based on the first signals, and a heart rate trend data based on the third signals.
the step of Observation and judgment of said presence or said absence of the confounding factor utilizes a tissue oxygenation parameter trend data based on the first signals, and a heart rate trend data based on the third signals.
evaluating the first signals using a magnitude of change filter.
Observation and judgment of the first signals using a magnitude of change filter.
determining a blood carbon dioxide (CO2) level of the subject.
Observation and judgment of a blood carbon dioxide (CO2) level of the subject.
determining said presence or said absence of the confounding factor utilizes the first subset of first signals and the second subset of first signals.
Observation and judgment of said presence or said absence of the confounding factor utilizes the first subset of first signals and the second subset of first signals.
determining said presence or said absence of the confounding factor utilizes a first tissue oxygenation parameter trend data based on the first subset of first signals, and a second tissue oxygenation parameter trend data based on the second subset of first signals.
Observation and judgment of said presence or said absence of the confounding factor utilizes a first tissue oxygenation parameter trend data based on the first subset of first signals, and a second tissue oxygenation parameter trend data based on the second subset of first signals.
evaluating the first signals to determine extracerebral blood flow as the confounding factor.
Observation and judgment of the first signals to determine extracerebral blood flow as the confounding factor.
all of which are grouped as mental processes or mathematical algorithms under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in each of Independent Claim 1 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified in Claims 1 – 31 and 50), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
“tissue oximeter”
“blood pressure sensing device”
“near infra-red spectroscopy (NIRS) tissue oximeter”
“one or more sensors”
“at least one light source”
“at least one near detector”
“at least one far detector”
Additional elements recited include “tissue oximeter”, “blood pressure sensing device”, “near infra-red spectroscopy (NIRS) tissue oximeter”, “one or more sensors”, “at least one light source”, “at least one near detector”, and “at least one far detector” in Independent Claim 1 (and its Dependent Claims). These components are recited at a high level of generality, , i.e., as a tissue oximeter performing a generic function of measuring an oxygenation parameter (the sensing). These generic hardware component limitations for “tissue oximeter”, “blood pressure sensing device”, “near infra-red spectroscopy (NIRS) tissue oximeter”, “one or more sensors”, “at least one light source”, “at least one near detector”, and “at least one far detector” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Independent Claim 1 and their dependent claims includes pre-solution activity limitations, such as:
continuously sensing a tissue region of a subject with a tissue oximeter, the sensing producing first signals representative of at least one tissue oxygenation parameter during a period of time;
continuously measuring a blood pressure level of the subject using a blood pressure sensing device during the period of time, the measuring producing second signals representative of the blood pressure of the subject during the period of time;
the at least one tissue oxygenation parameter includes one or more of tissue oxygen saturation (StO2), total hemoglobin concentration per volume of tissue (THb), relative total hemoglobin concentration per volume of tissue (rTHb), differential changes in oxyhemoglobin (O2Hb) and deoxyhemoglobin (HHb), or HbD.
wherein the at least one tissue oxygenation parameter includes a first tissue oxygenation parameter and a second oxygenation parameter;
wherein the first signals produced from the sensing include a first subset of first signals representative of the first tissue oxygenation parameter, and a second subset of first signals representative of the second tissue oxygenation parameter;
the first tissue oxygenation parameter is one of StO2, THb, rTHb, differential changes in oxyhemoglobin (O2Hb) and deoxyhemoglobin (HHb), or HbD, and the second tissue oxygenation parameter is another of StO2, THb, rTHb, differential changes in oxyhemoglobin (O2Hb) and deoxyhemoglobin (HHb), or HbD.
the tissue oximeter is a near-infrared spectroscopy type tissue oximeter.
the tissue being continuously sensed is brain tissue, and the autoregulation function state determined in the absence of the confounding factor is a brain autoregulation function state of the subject.
the step of continuously sensing the tissue region of the subject with the tissue oximeter, includes using one or more sensors in communication with the tissue oximeter, the one or more sensors each having at least one light source, at least one near detector located a first distance from the at least one light source, and at least one far detector located a second distance from the at least one light source, where the second distance is greater than the first distance.
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “tissue oximeter”, “blood pressure sensing device”, “near infra-red spectroscopy (NIRS) tissue oximeter”, “one or more sensors”, “at least one light source”, “at least one near detector”, and “at least one far detector” as recited in Independent Claim 1 (and its Dependent Claims) are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in Independent Claim 1 (and its dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Independent Claim 1 (and its dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claim 1 (and its dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 1 – 15 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “tissue oximeter”, “blood pressure sensing device”, “near infra-red spectroscopy (NIRS) tissue oximeter”, “one or more sensors”, “at least one light source”, “at least one near detector”, and “at least one far detector” as recited in Independent Claims 1, 8, and 9 (and their dependent claims).
The additional elements of the “tissue oximeter”, “blood pressure sensing device”, “near infra-red spectroscopy (NIRS) tissue oximeter”, “one or more sensors”, “at least one light source”, “at least one near detector”, and “at least one far detector” in Independent Claim 1 (and its dependent claims), as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the “tissue oximeter” and “near infra-red spectroscopy (NIRS) tissue oximeter” is described generically at [0019] with “the tissue oximeter may be a near-infrared spectroscopy (NIRS) type tissue oximeter,” and [0023] “The NIRS tissue oximeter is configured to continuously sense a tissue region of the subject during a period of time, and to produce first signals representative of at least one tissue oxygenation parameter during the period of time.” The “tissue oximeter” and “near infra-red spectroscopy (NIRS) tissue oximeter” are shown in as generic block element “tissue oximeter 24” in Fig. 4A and 4B.
Per Applicant’s specification, the “blood pressure sensing device” is described generically in [0099] with “The blood pressure sensing device 22 (“BP sensing device 22”) may be any sensor or device configured to continuously determine a subject's blood pressure (e.g., arterial blood pressure)” including “arterial catheter line”, “continuous non-invasive blood pressure device” or “pulse oximetry sensor”. The blood pressure sensing device is shown as generic block element “blood pressure sensing device 22” in Figs. 4A and 4B.
Per Applicant’s specification, the “one or more sensors”, “at least one light source”, “at least one near detector”, and “at least one far detector” are described generically at [0101] as part of the tissue oximeter, including “one or more light sources (e.g., light emitting diodes, or “LEDs”) and one or more light detectors (e.g., photodiodes, etc.).” The “one or more sensors” are not particularly shown in a figure beyond being part of “tissue oximeter 24” generic block element in Fig. 4A and 4B.
Accordingly, in light of Applicant’s specification, the claimed terms “tissue oximeter”, “blood pressure sensing device”, “near infra-red spectroscopy (NIRS) tissue oximeter”, “one or more sensors”, “at least one light source”, “at least one near detector”, and “at least one far detector” are reasonably construed as a generic computing and hardware devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “tissue oximeter”, “blood pressure sensing device”, “near infra-red spectroscopy (NIRS) tissue oximeter”, “one or more sensors”, “at least one light source”, “at least one near detector”, and “at least one far detector”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Independent Claim 1 (and its dependent claims) amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method of Claims 1 – 15 are directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1 – 15 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in Independent Claim 1 (and its dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1 – 15 apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1 – 15 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 – 15 are not patent eligible and rejected under 35 U.S.C. 101.
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 1 – 3, 6 – 7, and 9 – 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Montgomery et. al., (US 2016/0345913 A1).
Regarding Claim 1, Montgomery discloses A method for determining a subject's autoregulation function state ([Abstract]), comprising:
continuously sensing a tissue region of a subject with a tissue oximeter ([0033] “physiological
values ( e.g., the regional oxygen saturation values 44…)…may be provided to the controller 16 continuously…”; [0032] “oxygen saturation value 44…obtained from the patient…from the regional oxygen saturation sensor 14.”; Fig 2A), the sensing producing first signals representative of at least one tissue oxygenation parameter during a period of time ([0034] “…oxygen saturation measurements derived from the oxygen saturation values 44…” Fig 2A)
continuously measuring a blood pressure level of the subject using a blood pressure sensing device during the period of time ([0033] “physiological values ( e.g., the…blood pressure values 48…)…may be provided to the controller 16 continuously…”; [0032] “blood pressure value 48 obtained…from the blood pressure sensor 12”; Fig 2B), the measuring producing second signals representative of the blood pressure of the subject during the period of time ([0034] “blood pressure measurements derived from the blood pressure values 48…”; Fig 2B);
determining a presence or an absence of a confounding factor ([0027] “…noise…”) that affects the sensed at least one tissue oxygenation parameter in a manner independent of an autoregulation function of the subject (Fig 7,[0027] “identifying the pair of regression lines that exclude or ignore outliers indicative of noise…” [0028 ] p-value may indicate whether certain rSO2 values, or portions of rSO2 curve generated based on such values, are reliable or unreliable”), the determination using the first signals ([0027] - [0028 ] p-value may indicate whether certain rSO2 values, or portions of rSO2 curve generated based on such values, are reliable or unreliable”); and
using the first signals and the second signals to determine an autoregulation function state of the subject ([0034] “…monitor autoregulation of a patient based on one or more of the physiological signals received from the patient…plot the oxygen saturation measurements derived from the oxygen saturation values 44 against blood pressure measurements derived from the blood pressure values 48…”) when the absence of the confounding factor is determined ([0028] “…use the p-value to determine the most suitable pair of regression lines.”; Fig 7, [0037] “…accurately determine the LLA value 58 based on the pair of regression lines…”)
Regarding Claim 2, Montgomery discloses as described above, The method of claim 1. For the remainder of Claim 2, Montgomery discloses wherein the step of determining said presence or said absence of the confounding factor (Fig 7, [0027] – [0028]), further includes determining whether the confounding factor has affected the measured blood pressure level of the subject ([0043] “…data outliers…measurements indicative of signal noise… pressure measurements less than approximately 20 mmHg may be excluded from the regression line...”; Fig. 7) in a manner independent of the autoregulation function of the subject using the second signals ([0038] “…one or more outliers 72, 74 indicative of signal noise that may bias the left regression line 62 and/or the right regression line 64…”; [0043] “signal noise… pressure measurements less than approximately 20 mmHg may be excluded from the regression line...”; Fig 4; Fig. 7)
Regarding Claim 3, Montgomery discloses as described above, The method of claim 2. For the remainder of Claim 3, Montgomery discloses wherein the step of determining said presence or said absence of the confounding factor (Fig 7, [0027] – [0028]), utilizes a tissue oxygenation parameter trend data based on the first signals ([0038] “pair of linear correlations between oxygen saturation measurements 54 and the blood pressure measurements 56 to determine the LLA value 58…one or more outliers 72, 74 indicative of signal noise that may bias the left regression line 62 and/or the right regression line 64…”; Fig. 4), and a blood pressure level trend data based on the second signals ([0038] “pair of linear correlations between oxygen saturation measurements 54 and the blood pressure measurements…signal noise that may bias the left regression line 62 and/or the right regression line 64…”; Fig. 4)(Examiner notes that both trend data lines are based on both body oxygen saturation and blood pressure, the first and second signals.)
Regarding Claim 6, Montgomery discloses as described above, The method of claim 1. For the remainder of Claim 6, Montgomery discloses wherein the step of determining said presence or said absence of the confounding factor (Fig 7, [0027] – [0028]) further includes evaluating the first signals using a magnitude of change filter ([0039] “...the controller 16 may be configured to exclude or ignore one or more outliers 72, 74 and utilize the remaining data to determine the linear correlations (e.g., regression lines)… less than a predetermined threshold value in order to remove measurements that are most likely outliers”, “pre-determined threshold may be any oxygen saturation value, such as any oxygen saturation value approximately less than 50%...”)(Examiner notes at Applicant’s specification at [0155] that a magnification of change evaluation is described as evaluating a change in the data and determining if that “change is minimal (e.g., below a threshold amount”), which is consistent with Montgomery’s disclosure of filtering out (“exclude or ignore”) outlier data that is lower than a threshold.)
Regarding Claim 7, Montgomery discloses as described above, The method of claim 1. For the remainder of Claim 7, Montgomery discloses wherein the at least one tissue oxygenation parameter includes one or more of tissue oxygen saturation (StO2) ([0023] “generate a regional oxygen saturation (rSO2 ) signal for the target tissues over time…”; [0022] “…oxygen saturation signal…in the cerebral cortex”), total hemoglobin concentration per volume of tissue (THb), relative total hemoglobin concentration per volume of tissue (rTHb), differential changes in oxyhemoglobin (O2Hb) and deoxyhemoglobin (HHb), or HbD.
Regarding Claim 9, Montgomery discloses as described above, The method of claim 1. For the remainder of Claim 9, Montgomery discloses wherein the at least one tissue oxygenation parameter (([0034] “…oxygen saturation measurements derived from the oxygen saturation values 44…”) includes a first tissue oxygenation parameter ([0036] “oxygen saturation measurements 54…on the left side of the LLA value 58…”) and a second oxygenation parameter ([0036] “oxygen saturation measurements 54…on the right side of the LLA value 58…”); and
wherein the first signals produced from the sensing include a first subset of first signals representative of the first tissue oxygenation parameter ([0036] “oxygen saturation measurements 54…on the left side of the LLA value 58…”), and a second subset of first signals representative of the second tissue oxygenation parameter ([0036] “oxygen saturation measurements 54…on the right side of the LLA value 58…”); and
the step of determining said presence or said absence of the confounding factor utilizes the first subset of first signals and the second subset of first signals ([0038] “pair of linear correlations between oxygen saturation measurements 54 and the blood pressure measurements 56 to determine the LLA value 58…one or more outliers 72, 74 indicative of signal noise that may bias…the left regression line 62 and/or the right regression line 64…”; Fig. 4)
Regarding Claim 10, Montgomery discloses as described above, The method of claim 9. For the remainder of Claim 10, Montgomery discloses wherein the first tissue oxygenation parameter is one of StO2 ([0023] “generate a regional oxygen saturation (rSO2 ) signal for the target tissues over time…”; [0022] “…oxygen saturation signal…in the cerebral cortex”), THb, rTHb, differential changes in oxyhemoglobin (O2Hb) and deoxyhemoglobin (HHb), or HbD, and the second tissue oxygenation parameter is another of StO2 ([0023] “generate a regional oxygen saturation (rSO2 ) signal for the target tissues over time…”; [0022] “…oxygen saturation signal…in the cerebral cortex”), THb, rTHb, differential changes in oxyhemoglobin (O2Hb) and deoxyhemoglobin (HHb), or HbD.
Regarding Claim 11, Montgomery discloses as described above, The method of claim 9. For the remainder of Claim 11, Montgomery discloses wherein the step of determining said presence or said absence of the confounding factor (Fig 7, [0027] – [0028]) utilizes a first tissue oxygenation parameter trend data ([0038] “…left regression line 62”; Fig. 4) based on the first subset of first signals ([0038] “pair of linear correlations between oxygen saturation measurements 54 and the blood pressure measurements 56 to determine the LLA value 58…one or more outliers 72, 74 indicative of signal noise that may bias the left regression line 62…”; Fig. 4), and a second tissue oxygenation parameter trend data ([0038] “…right regression line 64”; Fig. 4) based on the second subset of first signals ([0038] “pair of linear correlations between oxygen saturation measurements 54 and the blood pressure measurements 56 to determine the LLA value 58…one or more outliers 72, 74 indicative of signal noise that may bias…the right regression line 64…”; Fig. 4)(Examiner notes that both trend data lines are based on both body oxygen saturation and blood pressure, the first and second signals.)
Regarding Claim 12, Montgomery discloses as described above, The method of claim 1. For the remainder of Claim 12, Montgomery discloses wherein the tissue oximeter is a near-infrared spectroscopy type tissue oximeter ([0023] “…the oxygen saturation sensor 14 may include an emitter 20… emit at different wavelengths of light, e.g., red or near infrared light…”)
Regarding Claim 13, Montgomery discloses as described above, The method of claim 1. For the remainder of Claim 13, Montgomery discloses wherein the tissue being continuously sensed is brain tissue ([0023] “(tissue in addition to the tissue through which the light received by the "close" detector passed, e.g., the brain tissue)…”), and the autoregulation function state determined in the absence of the confounding factor is a brain autoregulation function state of the subject ([0025] “…to evaluate the
patient's cerebral autoregulation status.”)
Claim Rejections - 35 USC § 103
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 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 4 – 5 are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery in view of Bienek et. al., (US 2018/0249916 A1).
Regarding Claim 4, Montgomery discloses as described above, The method of claim 1. For the remainder of Claim 4, Montgomery discloses further comprising determining a heart rate of the subject during the period of time ([0024] “blood pressure sensor 12 or the oxygen saturation sensor 14…measure other parameters, such as…heart rate…”; [0033]), and producing third signals representative of the subject's heart rate during the period of time ([0024] “blood pressure sensor 12 or the oxygen saturation sensor 14…measure other parameters, such as…heart rate…”; [0033]); and
wherein the step of determining said presence or said absence of the confounding factor (Fig 7, [0027] – [0028]).
Montgomery does not specifically disclose determining whether the confounding factor has affected the heart rate of the subject in a manner independent of the autoregulation function of the subject using the third signals.
Bienek teaches a method of monitoring and/or diagnosing an autoregulation mechanism of blood pressure of a subject using heart rate intervals measured with ECG, for which noise is present in heart rate-associated signals and smoothed with filters ([Abstract]; [0081]). Specifically for Claim 4, Bienek teaches determining whether the confounding factor has affected the heart rate of the subject in a manner independent of the autoregulation function of the subject using the third signals ([0057] “The respective time intervals (heart rate intervals) can thus be identified…”; [0081] “Appropriate smoothing filters are to be used or to be adjusted due to noise in the signals and specifically in the leads…”; [0082]);
Bienek provides a motivation to combine at [0009] with “…underlying regulation mechanisms are poorly pronounced, and the blood pressure variations are low. They can therefore easily be superimposed by noise and are thus not detected…” and [0081] “Appropriate smoothing filters are to be used or to be adjusted due to noise in the signals and specifically in the leads.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that each signal that is measured may have associated noise (such as noise in a heart rate signal when investigating autoregulation mechanisms), which would be a confounding factor to affect an overall analysis that requires examination of subtle changes in the signal.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Montgomery’s disclosed method for monitoring autoregulation using oxygen saturation, blood pressure, and heart rate sensors ([0024]) and determining noise associated with its sensors with the heart rate signal noise accommodation for autoregulation taught by Bienek, creating a single method for monitoring autoregulation using oxygen saturation, blood pressure, and heart rate sensors for which noise is noted in the each of the types of signals with the purpose of obtaining more accurate measurements of autoregulation.
Regarding Claim 5, Montgomery discloses as described above, The method of claim 4. For the remainder of Claim 5, Montgomery discloses wherein the step of determining said presence or said absence of the confounding factor (Fig 7, [0027] – [0028]) utilizes a tissue oxygenation parameter trend data based on the first signals ([0038] “pair of linear correlations between oxygen saturation measurements 54 and the blood pressure measurements 56 to determine the LLA value 58…one or more outliers 72, 74 indicative of signal noise that may bias the left regression line 62 and/or the right regression line 64…”; Fig. 4).
Montgomery does not specifically disclose a heart rate trend data based on the third signals.
Bienek teaches utilizes a tissue oxygenation parameter trend data based on the first signals, and a heart rate trend data based on the third signals ([0081] “Appropriate smoothing filters are to be used or to be adjusted due to noise in the signals and specifically in the leads.”; [0005] “ The heart rate is then plotted against the blood pressure (one respective value for each heartbeat), and a straight line is interpolated through the correspondingly activated region…”)(Examiner notes that a smoothing filter would result in signal data with best fit, or an overall trend of the heart rate signal.).
Bienek provides a motivation to combine at [0009] with “…underlying regulation mechanisms are poorly pronounced, and the blood pressure variations are low. They can therefore easily be superimposed by noise and are thus not detected…” and [0081] “Appropriate smoothing filters are to be used or to be adjusted due to noise in the signals and specifically in the leads.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that each signal that is measured may have associated noise (such as noise in a heart rate signal when investigating autoregulation mechanisms), which would be a confounding factor to affect an overall analysis that requires examination of subtle changes in the signal.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Montgomery’s disclosed method for monitoring autoregulation using oxygen saturation, blood pressure, and heart rate sensors ([0024]) and determining noise associated with its sensors with the heart rate signal noise accommodation for autoregulation taught by Bienek, creating a single method for monitoring autoregulation using oxygen saturation, blood pressure, and heart rate sensors for which noise is noted in the each of the types of signals with the purpose of obtaining more accurate measurements of autoregulation.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Montgomery in view of Hornick, (US 2011/0082357 A1).
Regarding Claim 8, Montgomery discloses as described above, The method of claim 1. For the remainder of Claim 8, Montgomery discloses wherein the step of determining said presence or said absence of the confounding factor (Fig 7, [0027] – [0028])
Hornick teaches a method of measuring the carbon dioxide level of blood in a patient, while removing noise or other unexpected high-frequency spikes from the measurement data using signal conditioning ([Abstract]; [0092]). Specifically for Claim 8, Hornick teaches further includes determining a blood carbon dioxide (CO2) level of the subject ([0015] “CO2 level is evaluated periodically, optionally providing continuous monitoring of the CO2 level of a patient.”; [0007] “…deriving an evaluation of CO2 level in the blood of a patient”).
Hornick provides a motivation to combine at [0014] with “…evaluation of CO2 level based on the simultaneous correlation between haemodynamic parameters may provide a better performance in terms such as precision and/or repeatability and/or consistency between patients and/or reliance on calibration relative to an evaluation based on a single parameter.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that evaluating blood gas and autoregulation would be more diagnostically complete with both oxygenation and carbon dioxide measurement, and that it would be important to evaluate if there are confounding noise effects associated with the carbon dioxide measurements to obtain the benefit of additional reliable diagnostic information.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Montgomery’s disclosed method for monitoring autoregulation using oxygen saturation sensors of the subject’s cranium and identifying portions of the oxygen saturation measurement that are noisy and unreliable ([Abstract], [0023], [0028]) with the blood carbon dioxide level measurement with noise filtering taught by Hornick, creating a single method for monitoring autoregulation using blood oxygen saturation and carbon dioxide sensors to determine more diagnostic details about the patient’s autoregulation.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery in view of Milej et. al., (“Direct assessment of extracerebral signal contamination on optical measurements of cerebral blood flow, oxygenation, and metabolism”, Ref U on PTO-8092).
Regarding Claim 14, Montgomery discloses as described above, The method of claim 13. For the remainder of Claim 14, Montgomery discloses wherein the step of determining said presence or said absence of the confounding factor (Fig 7, [0027] – [0028]) further includes evaluating the first signals ([0027] - [0028 ] p-value may indicate whether certain rSO2 values, or portions of rSO2 curve generated based on such values, are reliable or unreliable”);
Montgomery does not disclose to determine extracerebral blood flow as the confounding factor.
Milej teaches evaluating the confounding effects of scalp hemodynamics on near-infrared spectroscopy in combination with diffuse correlation spectroscopy (DCS) cerebral blood flow measurements that occur when making cerebral oxygenation measurements ([Abstract]; [Page 2, 3rd Full Paragraph]). Specifically for Claim 14, Milej teaches to determine extracerebral blood flow as the confounding factor ([Page 2, 1st Full Paragraph] “fluctuations in scalp hemodynamics can overshadow brain-related signals, and quantification of cerebral hemodynamics and metabolism requires accounting for signal contributions from the extracerebral layer (ECL)”; [Page 2, Top] “the blood flow index (BFI) from DCS to be converted into perfusion units…quantify CMRO2...”; [Page 2, 3rd Full Paragraph] “To evaluate the confounding effects of changes in scalp hemodynamics, data were acquired with and without temporarily restricting blood flow to the scalp by a pneumatic tourniquet wrapped around the head...”) Milej provides a motivation to combine at [Page 2, 1st Full Paragraph] with “…fluctuations in scalp hemodynamics can overshadow brain-related signals, and quantification of cerebral hemodynamics and metabolism requires accounting for signal contributions from the extracerebral layer (ECL).” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that detecting signal contamination at the scalp from extracerebral blood flow oxygen concentration measurements would be useful for determining reliability of cerebral oxygen concentration measurements overall for autoregulation determination.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Montgomery’s disclosed method for monitoring autoregulation using oxygen saturation sensors of the subject’s cranium and identifying portions of the oxygen saturation measurement that are noisy and unreliable ([Abstract], [0023], [0028]) with the Milej’s teaching that fluctuations in scalp hemodynamics can make extracerebral blood flow a source of confounding effects in cerebral oxygen saturation measurements, creating a single method for monitoring autoregulation using oxygen saturation sensors that can evaluate the reliability of its measurements from a variety of potential confounding factors, increasing the overall accuracy of its data reporting.
Regarding Claim 15, Montgomery discloses as described above, The method of claim 14. For the remainder of Claim 15, Montgomery discloses wherein the step of continuously sensing the tissue region of the subject with the tissue oximeter ([0033] “…the regional oxygen saturation values 44…continuously…”; [0032] “…from the regional oxygen saturation sensor 14.”; Fig 2A),, includes using one or more sensors in communication with the tissue oximeter ([0023] “…the oxygen saturation sensor 14 may include an emitter 20 and multiple detectors 22…”), the one or more sensors ([0023] “…emitter 20 and multiple detectors 22…”) each having at least one light source ([0023] “emitter 20…configured to emit light…”), at least one near detector located a first distance from the at least one light source ([0023] “One of the detectors 22 is positioned relatively "close" ( e.g., proximal) to the emitter 20…”), and at least one far detector located a second distance from the at least one light source ([0023] “…one of the detectors 22 is positioned relatively "far" (e.g., distal) from the emitter 22”), where the second distance is greater than the first distance ([0023] “…one of the detectors 22 is positioned relatively "far" (e.g., distal) from the emitter…”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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