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
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 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:
“mobile computing device” in claims 1, 11, and 18
“at least two optical sensors” in claims 1, 3,5, 11, 12, 17, and 18
“light source” in claims 1, 11 and 18
“physiological sensor” in claims 1, 11 and 18
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. Paragraph [0051] of the specification as filed defines a “mobile computing device” as a smartphone. . Paragraph [0074] of the specification as filed defines the “at least two optical sensors” as an array of optical detectors (e.g., LEDs) in the visual and/or IR and/or SWIR range. Paragraph [0074] of the specification as filed defines the “light source” as a laser. Paragraph [0084] of the specification as filed defines the “physiological sensor” as a blood pulse sensor.
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 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a series of steps or acts, including selecting at least one point of the patient's skin determined as a potential subdermal injury. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of selecting at least one point of the patient's skin determined as a potential subdermal injury sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites issuing an alert when a subcutaneous tissue injury is determined, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The alert does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the alert, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Claim 1 also contains the steps of training, by a processor of the mobile computing device, a machine learning (ML) algorithm to determine a tissue injury, wherein the training is carried out on a dataset of intensity and signal distance information and physiological characteristic information of the tissue obtained from the sensors; applying, by the processor, the ML algorithm on the received intensity and signal distance information and the received physiological characteristic information to determine a subcutaneous tissue injury in which liquids accumulate subcutaneously, in accordance with a calculated change in the received signal intensity and signal distance information, and the physiological characteristic information. These are abstract ideas in the form of mathematical concepts. Besides the Abstract Ideas, the claim recites additional steps of attaching a non-invasive device to a mobile computing device; receiving, by at least two optical sensors of the non-invasive device, intensity and signal distance information from light reflected from the tissue over at least one point of the patient's skin, including signal distance information measured between at least one light source and the at least two optical sensors; and receiving, by at least one physiological sensor, of the non-invasive device, over at least one point of the patient's skin, physiological characteristic information of the tissue. Connecting a device to a computer and receiving optical and physiological sensor data is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the connecting and receiving steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 11, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited a light source, optical sensors, and physiological sensor are generic light sources and sensors configured to perform pre-solutional data gathering activity, the display device is a generic device configured to perform data displaying, and the processor is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. The same rationale applies to claim 18.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-7, 10-14, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klein (US 20170303830 A1 – cited by applicant) in view of Kayser (US 20220095999 A1).
In regards to claim 1 Klein teaches a method of non-invasive determination of a tissue injury of a patient's tissue, the method comprising:
attaching a non-invasive device to a mobile computing device ([0092]) connection 36 is used to connect computer with device);
receiving, by at least two optical sensors of a non-invasive device, intensity and signal distance information from light reflected from the tissue over at least one point of the patient's skin, including signal distance information measured between at least one light source and the at least two optical sensors ([0106] two sensors [0167][0178] Raman spectroscopy inherently has signal distance information [0018] intensity);
receiving, by at least one physiological sensor, of the non-invasive device, over at least one point of the patient's skin, physiological characteristic information of the tissue ([0193 and 0196]);
training, by a processor of a mobile computing device, a machine learning (ML) algorithm to determine a tissue injury, wherein the training is carried out on a dataset of intensity and signal distance information and physiological characteristic information of the tissue obtained from the sensors ([0223] classifiers trained using Raman spectroscopy data which includes distance and intensity information, FTIR-ATR data, reflectance mode data, transmittance mode data and deterministic/vital signs parameters);
applying, by the processor, the ML algorithm on the received intensity and signal distance information and the received physiological characteristic information to determine a subcutaneous tissue injury in which liquids accumulate subcutaneously, in accordance with a calculated change in the received signal intensity and signal distance information, and the physiological characteristic information (([0125-0128] [0193][0223] deep tissue injury (DTI));
selecting, by the processor, at least one point of the patient's skin determined as a potential subdermal injury ([0125-0128]).
Klein fails to teach issuing, by the processor, an alert when a subcutaneous tissue injury is determined. Kayser teaches outputting an alert when a subcutaneous pressure injury is detected in order to prevent the injury from getting worse ([0043]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of Klein to include a step of outputting an alert when a tissue injury is detected in order to prevent the tissue injury from getting worse like the method of Kayser.
In regards to claim 2 modified Klein teaches the method of claim 1, wherein at least one other than the point determined as a potential subdermal injury is determined as healthy tissue by the processor (Klein [0125-0128]).
In regards to claim 3 modified Klein teaches the method of claim 1, further comprising applying modulated lighting so as to accelerate the measurement time by the at least two optical sensors (Klein [0213-0214]).
In regards to claim 4 modified Klein teaches the method of claim 3, wherein the modulated lighting comprises using a different frequency for different light sources simultaneously based on a Fast Fourier Transform algorithm (Klein [0213-0214]).
In regards to claim 5 modified Klein teaches the method of claim 1, wherein the signal is received from the at least two optical sensors in a plurality of wavelengths (Klein [0161]).
In regards to claim 6 modified Klein teaches the method of claim 1, wherein the physiological characteristic information of the tissue is selected from the group consisting of: blood flow pattern, blood flow rate, blood viscosity, tissue temperature, skin tissue capacitance, pulse wave velocity, skin elasticity, hemoglobin level, and spatial oxygenation (Klein [0196]).
In regards to claim 7 modified Klein teaches the method of claim 1, wherein the physiological characteristic information is determined based on detection of myoglobin in the tissue (Klein [0193]).
In regards to claim 10 modified Klein teaches the method of claim 1, further comprising measuring a reference point on a healthy tissue of the patient, in order to get a normalized personalized result for the patient ([0161] “The processor may determine the change in shape of a signal by calculating similarity of measured data sets with the predefined data with known (or calibrated) spectral response (e.g., for healthy tissue) and/or calculate a combined absorption graph (e.g., for a plurality of detectors)”).
In regards to claim 11 Klein teaches system for non-invasive determination of a tissue injury, of a patient's tissue, the system comprising:
a light source ([0192] light source);
at least two optical sensors, configured to receive intensity and signal distance information from light reflected from the tissue over at least one point of the patient's skin, including signal distance information measured between the light source and the at least two optical sensors ([0106] two sensors [0167][0178] Raman spectroscopy inherently has signal distance information [0018] intensity);
at least one physiological sensor, configured to receive over at least one point of the patient's skin physiological characteristic information of the tissue ([0193 and 0196]);
a processor of a mobile computing device, coupled to the at least two optical sensors and the at least one physiological sensor, wherein the processor is configured to (Fig.1A external processing device 30):
train a machine learning (ML) algorithm to determine a tissue injury, wherein the training is carried out on a dataset of intensity and signal distance information and physiological information of the tissue obtained from the sensors ([0223] classifiers trained using Raman spectroscopy data which includes distance and intensity information, FTIR-ATR data, reflectance mode data, transmittance mode data and deterministic/vital signs parameters);
apply the ML algorithm on the intensity and signal distance information obtained from the optical sensors to determine a subcutaneous tissue injury in which liquids accumulate subcutaneously, in accordance with a calculated change in the received signal intensity and signal distance information, and the physiological characteristic information, and display the determination (([0125-0128], [0193][0223] deep tissue injury (DTI), [0233-0234] display displays patient data, deep tissue injury determination is a type of patient data);
and select at least one point of the patient's skin determined as a potential subdermal injury ([0125-0128]).
Klein fails to teach issuing, by the processor, an alert when a subcutaneous tissue injury is determined. Kayser teaches outputting an alert when a subcutaneous pressure injury is detected in order to prevent the injury from getting worse ([0043]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the system of Klein to output an alert when a tissue injury is detected in order to prevent the tissue injury from getting worse like the device of Kayser.
In regards to claim 12 modified Klein teaches the system of claim 11, wherein a signal is received from the at least two optical sensors in a plurality of wavelengths (Klein [0161]).
In regards to claim 13 modified Klein teaches the system of claim 11, wherein the physiological characteristic information of the tissue is selected from the group consisting of: blood flow pattern, blood flow rate, blood viscosity, temperature, skin tissue capacitance, pulse wave velocity, skin elasticity, hemoglobin level in tissue, hemoglobin saturation rate, and spatial oxygenation level (Klein [0196]).
In regards to claim 14 modified Klein teaches the system of claim 11, wherein the physiological characteristic information is determined based on detection of myoglobin in the tissue (Klein [0196]).
In regards to claim 17 modified Klein teaches the system of claim 11, wherein the at least two optical sensors are to measure a reference point on a healthy tissue of the patient, in order to get a normalized personalized result for the patient ([0161] “The processor may determine the change in shape of a signal by calculating similarity of measured data sets with the predefined data with known (or calibrated) spectral response (e.g., for healthy tissue) and/or calculate a combined absorption graph (e.g., for a plurality of detectors)”)
In regards to claim 18 Klein teaches device for non-invasive determination of a tissue injury, of a patient's tissue, the device comprising:
a light source ([0192] light source);
at least two optical sensors, configured to receive intensity and signal distance information from light reflected from the tissue over at least one point of the patient's skin, including signal distance information measured between the light source and the at least two optical sensors ([0106] two sensors [0167][0178] Raman spectroscopy inherently has signal distance information [0018] intensity);
at least one physiological sensor, configured to receive over at least one point of the patient's skin physiological characteristic information of the tissue ([0193 and 0196]);
a processor of a mobile computing device, coupled to the at least two optical sensors and the at least one physiological sensor, wherein the processor is configured to (Fig.1A external processing device 30):
train a machine learning (ML) algorithm to determine a tissue injury, wherein the training is carried out on a dataset of intensity and signal distance information and physiological information of the tissue obtained from the sensors ([0223] classifiers trained using Raman spectroscopy data which includes distance and intensity information, FTIR-ATR data, reflectance mode data, transmittance mode data and deterministic/vital signs parameters);
apply the ML algorithm on the intensity and signal distance information and physiological information obtained from the optical sensors to determine a subcutaneous tissue injury in which liquids accumulate subcutaneously, in accordance with a calculated change in the received signal intensity and signal distance information, and the physiological characteristic information (([0125-0128], [0193][0223] deep tissue injury (DTI));
and select at least one point of the patient's skin determined as a potential subdermal injury ([0125-0128]).
Klein fails to teach issuing, by the processor, an alert when a subcutaneous tissue injury is determined. Kayser teaches outputting an alert when a subcutaneous pressure injury is detected in order to prevent the injury from getting worse ([0043]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the device of Klein to output an alert when a tissue injury is detected in order to prevent the tissue injury from getting worse like the device of Kayser.
Claim(s) 8 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klein (US 20170303830 A1) in view of Kayser (US 20220095999 A1) as applied to claims 1 and 11, further in view of Newberry (US 20190105001 A1).
In regards to claim 8 modified Klein teaches the method of claim 1, including a pressure sensor (Klein [0196]). Modified Klein fails to teach a method further comprising initiating a measurement when the pressure signal, from a pressure sensor, is within a predefined pressure threshold range. Newberry teaches initiating a measurement when pressure signal, from a pressure sensor, is within a predefined pressure threshold range ([0027 and 0095]). It would have been prima facie obvious to a person of ordinary skill in the art to modify the method of modified Klein so measurement is initiated when the pressure signal, from the pressure sensor, is within a predefined pressure threshold range like the method of Newberry. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of taking measurements when the sensor is exerting an ideal amount pressure on the skin in order for proper detection.
In regards to claim 15 modified Klein teaches the system of claim 11, including a pressure sensor (Klein [0196]). Modified Klein fails to teach a method further comprising initiating a measurement when the pressure signal, from a pressure sensor, is within a predefined pressure threshold range. Newberry teaches initiating a measurement when pressure signal, from a pressure sensor, is within a predefined pressure threshold range ([0027 and 0095]). It would have been prima facie obvious to a person of ordinary skill in the art to modify the device of modified Klein so measurement is initiated when the pressure signal, from the pressure sensor, is within a predefined pressure threshold range like the method of Newberry. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of taking measurements when the sensor is exerting an ideal amount pressure on the skin in order for proper detection.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klein (US 20170303830 A1) in view of Kayser (US 20220095999 A1) in view of Newberry (US 20190105001 A1) as applied to claim 8, further in view of Flitsch (US 20190105001 A1).
In regards to claim 9 modified Klein teaches the method of claim 8. Modified Klein fails to teach a method wherein the pressure sensor is accommodated in an elastomeric ring. Flitsch teaches an elastomeric pressure sensor ([0187]). It would have been prima facie obvious to a person of ordinary skill in the art to make the pressure sensor of modified Klein an elastomeric pressure sensor like the one of Flitsch. Doing so would merely be choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. It would also be obvious to make the elastomeric pressure sensor a ring as doing so would be a mere change in shape. MPEP 2144.04.IV.B
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klein (US 20170303830 A1) in view of Kayser (US 20220095999 A1) as applied to claim 11, further in view of Newberry (US 20190105001 A1) in view of Flitsch (US 20190105001 A1).
In regards to claim 16 modified Klein teaches the system of claim 11, including a pressure sensor (Klein [0196]). Modified Klein fails to teach a method further comprising initiating a measurement when the pressure signal, from a damping pressure mechanism, is within a predefined pressure threshold range. Newberry teaches initiating a measurement when pressure signal, from a pressure sensor, is within a predefined pressure threshold range ([0027 and 0095]). It would have been prima facie obvious to a person of ordinary skill in the art to modify the device of modified Klein so measurement is initiated when the pressure signal, from the pressure sensor, is within a predefined pressure threshold range like the method of Newberry. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of taking measurements when the sensor is exerting an ideal amount pressure on the skin in order for proper detection.
Modified Klein in view of Newberry fails to teach a damping pressure mechanism. Flitsch teaches an elastomeric pressure sensor ([0187] which inherently has a damping pressure mechanism). It would have been prima facie obvious to a person of ordinary skill in the art to make the pressure sensor of modified Klein in view of Newberry an elastomeric pressure sensor like the one of Flitsch. Doing so would merely be choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LUCY EPPERT/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791