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 .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: “System and Method for Generating a Visualization of Oxygen Levels”. The application appears to be titled “Assessing a Subject’s Adherene to a Treatment for a Condition” on the Application Data Sheet dated 11/08/2023. However, the suggestion is consistent with the title submitted in the specification also submitted on 11/08/2023. The suggestion aligns better with the subject matter of the claimed invention.
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:
“device” that is configured “to emit electromagnetic radiations at at least two distinct optical wavelengths” in claims 11 and 12.
The claim limitation is interpreted according to paragraph [Page 9, 1st Full Paragraph] “The device 140 may, for example, comprise one or more LEDs” and “device 140” of Figure 1.
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 § 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 apparatus, which is one of the statutory categories of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Regarding Claim 14, 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 claim is 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, Claims 1 – 15 recite (underlined are observations, judgments, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim 1
A processing system for generating a visualization of oxygen levels in tissue of an anatomical structure of a subject, the processing system being configured to:
receive vessel location data representative of locations of vessels in the anatomical structure;
receive at least one oxygen level measurement of the tissue at respective at least one location in the anatomical structure;
interpolate the at least one oxygen level measurement, using the vessel location data, the at least one oxygen level measurement at respective at least one location in the anatomical structure, to ascertain oxygen levels throughout the tissue of the anatomical structure; and
generate the visualization of oxygen levels in the tissue of at least a portion of the anatomical structure
Claim 14
A computer-implemented method for generating a visualization of oxygen levels in tissue of an anatomical structure of a subject, the computer-implemented method comprising:
receiving data representative of locations of vessels in the anatomical structure;
receiving at least one oxygen level measurement of the tissue at respective at least one location in the anatomical structure;
interpolating the at least one oxygen level measurement, using the vessel location data, the at least one oxygen level measurement at respective at least one location in the anatomical structure, to ascertain oxygen levels throughout the tissue of the anatomical structure; and
generating the visualization of oxygen levels in the tissue of at least a portion of the anatomical structure.
(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 Claims 1 and 14, these limitations include:
Observation and judgment of vessel location data representative of locations of vessels in the anatomical structure;
Observation and judgment of at least one oxygen level measurement of the tissue at respective at least one location in the anatomical structure;
Evaluate by interpolating the at least one oxygen level measurement, using the vessel location data, the at least one oxygen level measurement at respective at least one location in the anatomical structure, to observe and judge oxygen levels throughout the tissue of the anatomical structure;
Observation and judgment to generate the visualization of oxygen levels in the tissue of at least a portion of the anatomical structure
all of which are grouped as mental processes under the 2019 PEG.
Similarly, Dependent Claims 2 – 13, and 15 include the following abstract limitations, in addition the aforementioned limitations in Independent Claims 1 and 14 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
generate the visualization of oxygen levels in the tissue in relation to the vessels in the anatomical structure based on the vessel location data and the ascertained oxygen levels.
Observation and judgment to generate the visualization of oxygen levels in the tissue in relation to the vessels in the anatomical structure based on the vessel location data and the ascertained oxygen levels.
interpolate the at least one oxygen level measurement by processing the vessel location data and the at least one oxygen level measurement using a model of perfusion of the anatomical structure.
Evaluate by interpolating the at least one oxygen level measurement by processing the vessel location data and the at least one oxygen level measurement using a model of perfusion of the anatomical structure.
obtain a contour of the anatomical structure;
observe and judge a contour of the anatomical structure;
overlay the ascertained oxygen levels on the obtained contour of the anatomical structure;
observation and judgment to overlay the observed and judged oxygen levels on the obtained contour of the anatomical structure;
overlay representations of the vessels over the obtained contour of the anatomical structure based on the vessel location data
observation and judgment to overlay representations of the vessels over the obtained contour of the anatomical structure based on the vessel location data
identify potential diseased vessel or micro-vessel segments based on the vessel location data and the at least one oxygen level measurement
observation and judgment to identify potential diseased vessel or micro-vessel segments based on the vessel location data and the at least one oxygen level measurement;
overlay an indication of a location of the potential diseased vessel or micro-vessel segments on the generated visualization.
observation and judgment to overlay an indication of a location of the potential diseased vessel or micro-vessel segments on the generated visualization.
receive the at least one oxygen level measurement of the tissue in the anatomical structure from the oxygen level measurement system;
observation and judgment of the at least one oxygen level measurement of the tissue in the anatomical structure from the oxygen level measurement system;
calculate at least one oxygen level measurement based on optical measurements from the sensor.
evaluate at least one oxygen level measurement based on optical measurements from the sensor.
all of which are grouped as mental processes or certain methods of directing human activity 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 Claims 1 and 14 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified above in Independent Claims 1 and 14), 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:
“oxygen level measurement system”
“display device”
“device configured to emit electromagnetic radiations
“sensor”
“processor”
“computer program product”
“processing system”
Additional elements recited include an “oxygen level measurement system”, “display device”, “device configured to emit electromagnetic radiations”, “sensor”, “processor”, “computer program product”, and “processing system” in the Independent Claims 1 and 14, their dependent claims. These component are recited at a high level of generality, , i.e., as a generic computer processor performing a generic function of processing data (the receiving, interpolating, and generating) and a sensor performing a generic function of measuring data (the measuring). These generic hardware component limitations for “oxygen level measurement system”, “display device”, “device configured to emit electromagnetic radiations”, “sensor”, “processor”, “computer program product”, and “processing system” 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 Dependent Claims 2- 13 and 15 include pre-solution activity limitations, such as:
wherein the anatomical structure is an organ, preferably, a heart
wherein the generated visualization further includes an indication of a location in which no oxygen level measurement is available
wherein the at least one oxygen level measurement is based on a difference in optical characteristics at different wavelengths
an oxygen level measurement system configured to measure at least one oxygen level in the tissue of the anatomical structure based on a difference in optical characteristics at different wavelengths, to thereby generate at least one oxygen level measurement;
a display device configured to receive, from the processing system, and display the generated visualization
a device configured to emit electromagnetic radiations at least two distinct optical wavelengths;
a sensor configured to measure optical characteristics of tissue to thereby generate optical measurements
the device and sensor are configured to be positioned such that the tissue is located between the device and sensor during the optical measurements; or
the device and sensor are configured to be positioned on a same side of the tissue during optical measurements.
output the further visualization to the display device.
A computer program product comprising computer program code means which, when executed on a processing system, cause the processing system to perform the steps of the method according to claim 14.
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 “oxygen level measurement system”, “display device”, “device configured to emit electromagnetic radiations”, “sensor”, “processor”, “computer program product”, and “processing system” as recited in Independent Claims 1 and 14 and their 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 Claims 1 and 14 (and their respective 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 Claims 1 and 14 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claims 1 and 14 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 1 – 20 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: “oxygen level measurement system”, “display device”, “device configured to emit electromagnetic radiations”, “sensor”, “processor”, “computer program product”, and “processing system” as recited in Independent Claims 1 and 14 and their dependent claims.
The additional elements of the “oxygen level measurement system”, “display device”, “device configured to emit electromagnetic radiations”, “sensor”, “processor”, “computer program product”, and “processing system” Claims 1 - 15, 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 “oxygen level measurement system” is described on [Page 8, Bottom] – [Page 9, Top] “the oxygen level measurement system comprises a device 140 configured to emit at least two, different wavelengths of light, a sensor 150 configured to measure light, and a processor 160 configured to calculate at least one oxygen level measurement based on light measurements from the sensor” and [Page 9, lines 20 – 25] “alternative oxygen level measurement systems that measure at least one oxygen level in muscular tissue in an anatomical structure based on a different in light penetration between different wavelengths of light through the muscular tissue are also envisaged.” The “oxygen level measurement system” is likely shown as components 140, 150, and 160 of Figure 1.
Per Applicant’s specification, the “display device” is defined generically at [Page 13, Lines 16 – 17] as “display device 120, which is configured to receive and display the first visualization.“ It is shown as “display device 120” in Figure 1.
Per Applicant’s specification, the “sensor” is defined generically at [Page 4, Lines 16 – 17] as “a sensor (or detector) configured to measure light, to thereby generate light measurements “ and it is described generally as position on different delivery mechanisms at [Page 9] “sensor 150…a light-sensitive sensor” and [Page 10, 1st Full Paragraph]. It is shown as “sensor 150” in Figure 1.
Per Applicant’s specification, the “processor” and “processing system” are defined generically at [Page 20, 2nd and 3rd Full Paragraph] as “processor can be implemented in numerous ways…software…hardware…microprocessors…combination of dedicated hardware…” It is shown as “processor 160” in Figure 1.
Per Applicant’s specification, the “computer program product”, is defined generically at [Page 20, 1st Full paragraph] as “computer program comprising code means for implementing any described method when said program is run on a processing system.” It is not shown in a figure.
Per Applicant’s specification, as described above in the 112(f) interpretation, the “device configured to emit electromagnetic radiations” is described generically in paragraph [Page 9, 1st Full Paragraph] as “The device 140 may, for example, comprise one or more LEDs”. It is shown as “device 140” of Figure 1.
Accordingly, in light of Applicant’s specification, the claimed terms “oxygen level measurement system”, “display device”, “device configured to emit electromagnetic radiations”, “sensor”, “processor”, “computer program product”, and “processing system” 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 “oxygen level measurement system”, “display device”, “device configured to emit electromagnetic radiations”, “sensor”, “processor”, “computer program product”, and “processing system”. 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 Claims 1 – 15 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 apparatus and 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 Claims 1 and 14 (and their 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 merely 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 are rejected under 35 U.S.C. 101.
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 3 is 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 3, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “wherein the anatomical structure is an organ”, and the claim also recites “preferably a heart” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purposes of examination, the term “wherein the anatomical structure is an organ, preferably the heart” is deemed to claim “wherein the anatomical structure is an organ.”
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 1 – 4, 8 – 12, and 14 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kaestle, (United States Patent Application Publication US 2017/0319114 A1), hereinafter Kaestle, in view of Sarrafzadeh, et. al., (United States Patent Application Publication US 2014/0024905 A1), hereinafter Sarrafzadeah.
Regarding Claims 1 and 14, Kaestle discloses
For Claim 1: A processing system for generating a visualization of oxygen levels in tissue of an anatomical structure of a subject ([Abstract]),, the processing system being configured to:
For Claim 14: A computer-implemented method for generating a visualization of oxygen levels in tissue of an anatomical structure of a subject ([Abstract]; [0022] “…computer…perform the steps of the proposed processing method”), the computer-implemented method comprising:
For the remainder of both Claims 1 and 14, Kaestle discloses: receive vessel location data representative of locations of vessels in the anatomical structure ([Fig 2, [0060] “…skin tissue 101 comprises blood vessels 102; [0065] “…different radiation absorbance at blood vessels…”);
receive at least one oxygen level measurement of the tissue at respective at least one location in the anatomical structure ([0074] “For SpO2, intuitive colors can be used like bright red (areas 60) for high oxygen saturation values and blue (areas 61) for low values.”; Fig 6; [0080] “…determining, per body part of interest, the perfusion index and the blood oxygen saturation level…”; Fig 2 and 3);
ascertain oxygen levels throughout the tissue of the anatomical structure (Fig 6; [0080] “…determining…perfusion index and the blood oxygen saturation level…”; Fig 2 and 3); and
generate the visualization of oxygen levels in the tissue of at least a portion of the anatomical structure (Fig 5; Fig 6; [0074] “…SpO2…bright red (areas 60) for high oxygen saturation values and blue (areas 61) for low values…”; [0080] “…determining, per body part of interest, the perfusion index and the blood oxygen saturation level…”);
Kaestle does not specifically disclose interpolate the at least one oxygen level measurement, using the vessel location data, the at least one oxygen level measurement at respective at least one location in the anatomical structure
Sarrafzadeh teaches a perfusion scanner that uses PPG signals to measure blood oxygen levels in skin and interpolates these values to create a perfusion map that is overlaid on an image of the skin area. Specifically for Claims 1 and 14, Sarrafzadeh teaches interpolate the at least one oxygen level measurement, using the vessel location data ([0087] “…interpolation of blood oximeter data may be conducted using sensor tracking data…”), the at least one oxygen level measurement at respective at least one location in the anatomical structure, to ascertain oxygen levels throughout the tissue of the anatomical structure ([0087] “…oximeter sensor 16 provides absolute SPO2 readings…when associated with the location it was taken from, can be used to generate a map of blood oxygenation”).
Sarrafzadeh provides a motivation to combine at [0087] with “In order to provide a more informative map of perfusion in a local region, interpolation of blood oximeter data may be conducted using sensor tracking data.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that interpolating between data points is a common calculation method to estimate a value between two measurands, with applications such as that taught by Sarrafzadeh of generating an oxygen perfusion map of an anatomic area.
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 the oxygen measurement system with the oxygen level measurement and mapping device disclosed by Kaestle with the interpolation of oxygen measured values using their measurement position taught by Sarrafzadeh, creating a single oxygen level measurement and mapping device that interpolates measurements at points in an anatomic area of interest to display its informative perfusion map.
Regarding Claim 2, Kaestle in view of Sarrafzadeh discloses as described above, The processing system of claim 1. For the remainder of Claim 2, Kaestle discloses wherein the processing system ([Abstract]) is further configured to:
generate the visualization of oxygen levels in the tissue in relation to the vessels (Fig 5 and Fig 6; Fig 2, “blood vessels 102”; [0065] “a degree of arterial blood oxygen saturation can be reflected in different radiation absorbance at blood vessels.”; Fig 2 and 3) in the anatomical structure based on the vessel location data (Fig 3; [0072] “square grid pattern…”; [0065] “degree of arterial blood oxygen saturation can be reflected in different radiation absorbance at blood vessels.”; Fig 2 and 3, “vessels 102”) and the ascertained oxygen levels (Fig 5; Fig 6; [0074] “…SpO2…bright red (areas 60) for high oxygen saturation values and blue (areas 61) for low values…”; [0065] …different radiation absorbance at blood vessels”; Fig 2 and 3, “blood vessels 102”; [0060] “…represents the time-variant perfusion of the skin tissue 101 with its blood vessels 102”)
Regarding Claim 3, Kaestle in view of Sarrafzadeh discloses as described above, The processing system of claim 1. For the remainder of Claim 3, Kaestle discloses wherein the anatomical structure is an organ ([0003]; [0060] “skin tissue 101…”; [0067] “any selected region of interest (ROI) of skin exposed to the imaging unit…derive the pulse oximetry raw waveforms”)(Examiner notes that skin is an organ.), preferably, a heart (See 112(b) interpretation above)
Regarding Claim 4, Kaestle in view of Sarrafzadeh discloses as described above, The processing system of claim 1. For the remainder of Claim 4, Kaestle discloses wherein the processing system ([Abstract]) is configured to process the vessel location data (Fig 5 and Fig 6; Fig 2, “blood vessels 102”; [0065] “a degree of arterial blood oxygen saturation can be reflected in different radiation absorbance at blood vessels.”; Fig 2) and the at least one oxygen level measurement ([0074] “For SpO2, intuitive colors can be used like bright red (areas 60) for high oxygen saturation values and blue (areas 61) for low values.”; Fig 6; [0080] “…determining, per body part of interest, the perfusion index and the blood oxygen saturation level…”; Fig 3);
Kaestle does not specifically disclose interpolate the at least one oxygen level measurement by processing the vessel location data and the at least one oxygen level measurement using a model of perfusion of the anatomical structure.
Sarrafzadeh teaches interpolate the at least one oxygen level measurement by processing the location data and the at least one oxygen level measurement ([0087] “…interpolation of blood oximeter data may be conducted using sensor tracking data…”) using a model of perfusion of the anatomical structure (Fig 17, Inputs of “perfusion data 228” and “position data extraction” 232 and “location mapping” 234 into “Interpolation and overlay 236”; [0054] “a perfusion oxygenation monitoring (POM) system 10 for analyzing a region of tissue 52 of a patient”;[0092] “outputting a mapped and interpolated perfusion image”).
The motivation for Claim 4 to combine Kaestle with Sarrafzadeh is similar to that described in more detail in Claims 1 and 14. In summary, 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 the oxygen measurement system with the oxygen level measurement and mapping device disclosed by Kaestle with the interpolation of oxygen measured values using their measurement position taught by Sarrafzadeh, creating a single oxygen level measurement and mapping device that interpolates measurements at points in an anatomic area of interest to display its informative perfusion map.
Regarding Claim 8, Kaestle in view of Sarrafzadeh discloses as described above, The processing system of claim 1. For the remainder of Claim 8, Kaestle discloses wherein the generated visualization further includes an indication of a location in which no oxygen level measurement is available (Fig 4, Dotted “T” area where the diaper obscures the skin; [0106] ““odd” areas are excluded from the region of interest. “Odd” areas include body surface areas that do not expose bare skin, e.g. diapers…”; [0073] “..trunk (T)”; [0075] “…basically naked maybe except some diapers”; Fig 6)(Examiner notes that no oxygen measurement is available for the skin that is covered from the sensors by a diaper.).
Regarding Claim 9, Kaestle in view of Sarrafzadeh discloses as described above, The processing system of claim 1. For the remainder of Claim 9, Kaestle discloses wherein the at least one oxygen level measurement ([0074] “For SpO2 intuitive colors can be used like bright red (areas 60) for high oxygen saturation values and blue (areas 61) for low values.”; Fig 6) is based on a difference in optical characteristics at different wavelengths ([0017] “determining the blood oxygen saturation level for said plurality of pixels and/or pixel groups of the subject from pulse oximetry waveforms for at least two different wavelengths…”; [0064] “An oxygen saturation estimation algorithm can make use of a ratio of the signals related to the red and the infrared portion.”, “PPG device basically detects a ratio of (spectral) signal portions which has to be transferred into a blood oxygen saturation value which typically involves a ratio of HbO2 and Hb”)(Examiner notes that the difference is shown by a ratio between the values, where the numerator and denominator form a relation to show the degree that the values are not the same; [0062] “time variant intensity…curve 26…time-variant reflection”; Fig 2))
Regarding Claim 10, Kaestle in view of Sarrafzadeh discloses the processing system of claim 1 (See citation in claim 1), configured to receive the at least one oxygen level measurement of the tissue in the anatomical structure from the oxygen level measurement system ([0074] “For SpO2, intuitive colors can be used like bright red (areas 60) for high oxygen saturation values and blue (areas 61) for low values.”; Fig 6; [0080] “…determining, per body part of interest, the perfusion index and the blood oxygen saturation level…”);
For the remainder of Claim 10, Kaestle discloses A system for generating and displaying a visualization of oxygen levels in tissue of an anatomical structure of a subject ([Abstract]; Fig 3, [0074]; [0080]), the system comprising:
an oxygen level measurement system ([0001] “a system for screening of the state of oxygenation of a subject”) configured to measure at least one oxygen level in the tissue of the anatomical structure ([0074] “For SpO2 intuitive colors can be used like bright red (areas 60) for high oxygen saturation values and blue (areas 61) for low values.”; Fig 6) based on a difference in optical characteristics at different wavelengths ([0017] “determining the blood oxygen saturation level for said plurality of pixels and/or pixel groups of the subject from pulse oximetry waveforms for at least two different wavelengths…”; [0064] “An oxygen saturation estimation algorithm can make use of a ratio of the signals related to the red and the infrared portion.”, “PPG device basically detects a ratio of (spectral) signal portions which has to be transferred into a blood oxygen saturation value which typically involves a ratio of HbO2 and Hb”)(Examiner notes that the difference is shown by a ratio between the values.) , to thereby generate at least one oxygen level measurement ([0062] “time variant intensity…curve 26…time-variant reflection”; Fig 2);
a display device ([0030] “display”), configured to receive, from the processing system, and display the generated visualization ([0030] “display for displaying an oxygenation image of the subject in which for selected pixels and/or pixel groups the respective blood oxygen saturation level is displayed.”, “a clear gradient from right upper extremity (right shoulder/arm/hand) towards the rest of the body it gives a good confidence about a cyanotic CCHD issue.”).
Regarding Claim 11, Kaestle in view of Sarrafzadeh discloses as described above, The system of claim 10. For the remainder of Claim 11, Kaestle discloses wherein the oxygen level measurement system ([0001]) comprises:
a device configured to emit electromagnetic radiations at least two distinct optical wavelengths ([0004] “evaluating the transmissivity and/or reflectivity at different wavelengths (typically red and infrared), the blood oxygen saturation can be determined.”; [0043] “a light source for emission of light at said first wavelength and/or at said second wavelength”));
a sensor ([0061] “detection unit…image sensor”) configured to measure optical characteristics of tissue ([0062] “time-variant intensity incident on the image sensor of the detection unit 22…intensity modulation…time-variant reflection in the skin tissue 101 at the second wavelength”; Fig 2), to thereby generate optical measurements ([0062] “time variant intensity…curve 26…time-variant reflection”; Fig 2); and
a processor ([0022] “processor, causes said steps of the processing method disclosed herein to be performed”) configured to calculate at least one oxygen level measurement based on optical measurements from the sensor ([0064] “An oxygen saturation estimation algorithm can make use of a ratio of the signals related to the red and the infrared portion”; [0065] “measured intensity curve 26, 27 as a characteristic signal…arterial blood oxygen saturation-representative values can be computed…behavior of the AC portion of the characteristic signal….”).
Regarding Claim 12, Kaestle in view of Sarrafzadeh discloses as described above, The system of claim 11. For the remainder of Claim 12, Kaestle discloses wherein:
the device and sensor are configured to be positioned such that the tissue is located between the device and sensor during the optical measurements; or
the device ([0043] “the system further comprises a light source for emission of light at said first wavelength and/or at said second wavelength…”; [0060] “light source 21”) and sensor ([0060] “detection unit 22”) are configured to be positioned on a same side of the tissue during optical measurements (Fig 1; Fig 2 showing the light source 21 and “detection unit 22” above the “skin tissue 101”).
Regarding Claim 15, Kaestle in view of Sarrafzadeh discloses A computer program product ([0022] “a computer program”) comprising computer program code means which, when executed on a processing system cause the processing system to perform the steps of the method ([0022] “…comprises program code means…perform the steps of the proposed processing method”) according to claim 14 (See citation in Claim 14).
Claims 5 – 7 are rejected under 35 U.S.C. 103 as being unpatentable over Kaestle in view of Nagao (United States Patent Application Publication US 2011/0306868 A1), hereinafter Nagao.
Regarding Claim 5, Kaestle in view of Sarrafzadeh