DETAILED ACTION
Claims 1-20 are pending and hereby under examination.
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 Objections
Claim 10 and 11 are objected to because of the following informalities:
Claim 10, line 1 should read “wherein describing transformed PPG signals …” for consistent language of claim 1.
Claim 11, line 1, “a comparison” should read “the comparison” as a comparing step is already recited in claim 2.
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.
“means for a communication interface” first recited in claim 20.
The identified structure for the corresponding claim limitation is as follows:
“means for a communication interface” is identified as “The communication module 213 may be used to transmit data from or to the wearable device. According to an embodiment of the disclosure, the communication module 213 may include a wireless communication module (for example, a cellular/mobile communication module, a short-range wireless communication module, or a global navigation satellite system (GNSS) communication module) or a wired communication module (for example, a local area network (LAN) communication module, or a power line communication (PLC) module). Thus, the communication module 213 can support establishing a wireless communication channel between the wearable device 201 and an external device (for example, a device 225, a device 226, a server 227 or a cloud storage 229) and performing communication via the established communication channel. The communication module 213 may include one or more communication processors that operate independently from the processor 203 and support direct (for example, wired) communication or wireless communication. The respective one of these communication modules may communicate with an external electronic device via a first network 228 (for example, a short-range communication network, such as Bluetooth™, wireless communication (Wi-Fi), or infrared data transmission (IrDA)) or a second network 228 (for example, a long-range communication network, such as a cellular/mobile network, an Internet, or a computer network, for example, a local area network (LAN) or a wide area network (WAN)). These different types of communication modules can be implemented as a single component (for example, a single chip) or can be multi-component (for example, a plurality of chips)” (Paragraph 00157).
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 2, 5, 8, 9, 11, 13, 14, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, it is unclear if the “set of amplitude-phase characteristic” of the harmonics are the same, similar to, or different from the “set of characteristics” determined in claim 1 and later recited in claim 2, line 10. Are the “set of characteristics” determined in claim 1 used in the comparison step with the database, or is the “set of amplitude-phase characteristics” used in this comparison? For examination purposes, the claim will be interpreted that the “set of characteristics” from claim 1 are used; however, Applicant should clarify the relationship between the two sets. Claims 8, 9, 11, and 13 are also rejected due to their dependence on claim 2.
Regarding claim 5, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For examination purposes, the claim will be interpreted such that one wavelength is in a range of 495-570nm. See MPEP § 2173.05(d).
Regarding claim 10, it is unclear if the “set of amplitude-phase characteristics of the harmonics” are the same, similar to, or different from the “set of characteristics” determined in claim 1. Applicant discloses that a “set of characteristics” includes a set of amplitudes and/or phases of each wavelength (Paragraph 00222). Applicant discloses that a “set of amplitude-phase characteristics” include an instantaneous spectrum, spectral density, or the like (Paragraph 00164). For examination purposes, the sets will be interpreted as different sets; however, Applicant should clarify the relationship between the two sets.
Claim 10 recites the limitation "the set of amplitude-phase characteristics" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the user profile data" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 14, it is unclear if “the user profile data” is the data related to the user of the device or “other users” as recited in claim 11. For examination purposes, claim 14 will be interpreted as “the user profile data” is data from the current user of the device.
Regarding claim 17, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For examination purposes, the claim will be interpreted such that the device is a smart device. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-7, 12, and 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kulcke (US 20190028662).
Regarding claim 1, Kulcke teaches a wearable device with a function of determining a hemoglobin concentration in a user’s blood, the wearable device comprising:
at least one photoplethysmographic (PPG) sensor (Paragraph 0099, plethysmogram) configured to irradiate a tissue of the user with radiation of at least two different wavelengths and to detect at least two PPG signals at the at least two different wavelengths in a reflection mode (Paragraph 0119; Paragraph 0120, reflection),
transform the at least two PPG signals from a time domain to a frequency domain or time-frequency domain (Paragraph 0047),
describe the transformed PPG signals with respect to harmonics to obtain a set of characteristics (Paragraphs 0047-0049), and
determine a hemoglobin concentration in the user's blood based on the obtained set of characteristics (Paragraph 0048, determining hemoglobin; Paragraph 0060, hemoglobin concentration) and an information from a database (Paragraph 0104, wherein the device contains a memory device for reference data).
Regarding claim 3, Kulcke further teaches wherein the at least one PPG sensor comprises at least one radiation source comprising two or more light-emitting diodes (Paragraph 0119, matrix of LEDs).
Regarding claim 4, Kulcke further teaches at least one radiation detector (Paragraph 0122), preferably being a wide-bandwidth photodetector.
Regarding claim 5, Kulcke further teaches wherein one of the at least two different wavelengths is in a range of 495-570nm (Paragraph 0061, wavelength about 520nm), and preferably is 530 nm.
Regarding claim 6, Kulcke further teaches wherein the wearable device is further configured to filter out motion artifacts from the PPG signals (Paragraphs 0073 and 0195).
Regarding claim 7, Kulcke further teaches wherein the transformation of the PPG signals from the time domain to the frequency domain comprises a Fourier transform (Paragraph 0047, Fourier transform).
Regarding claim 12, Kulcke further teaches a memory configured to store the database (Paragraph 0104, wherein the device contains a memory device for reference data).
Regarding claim 15, Kulcke further teaches wherein the wearable device is further configured to determine an oxyhemoglobin concentration in the user’s blood (Paragraphs 0043 and 0060).
Regarding claim 16, Kulcke further teaches wherein the wearable device is configured to be placed on a wrist (Paragraph 0118, use on the wrist).
Regarding claim 17, Kulcke further teaches wherein the wearable device is a smart device, preferably a smartwatch or a fitness bracelet (Paragraph 0118, fitness tracker or smart watch).
Regarding claim 18, Kulcke teaches a method for determining a hemoglobin concentration in a user’s blood, the method comprising:
irradiating a tissue of the user with radiation of at least two different wavelengths (Paragraph 0119; Paragraph 0120, reflection);
detecting photoplethysmographic (PPG) signals (Paragraph 0099, plethysmogram) from the user’s tissue in a time domain at the at least two different wavelengths in a reflection mode (Paragraph 0120);
transforming the detected PPG signals from the time domain to a frequency domain or time-frequency domain (Paragraph 0047);
describing the transformed PPG signals with respect to harmonics to obtain a set of characteristics (Paragraphs 0047-0049), and
determining a hemoglobin concentration in the user's blood based on the obtained set of characteristics (Paragraph 0048, determining hemoglobin; Paragraph 0060, hemoglobin concentration) and an information from a database (Paragraph 0104, wherein the device contains a memory device for reference data).
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.
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 2, 8-9, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kulcke as applied to claim 1 and 18 above, and further in view of Schweitzer (US 20060063994).
Regarding claim 2, Kulcke discloses wherein the wearable device is configured to, when describing the PPG signals:
select the most significant signal from all the PPG signals and use it as a reference signal (Paragraph 0048, determining the wavelength in which the pulse signal is clearer),
extract the harmonics from the reference signal and use the extracted harmonics as coordinates (Paragraph 0047; Fig. 10, fundamental frequency at 25, harmonic frequencies at 27/29), and
decompose all the PPG signals according to the coordinates to obtain a set of amplitude-phase characteristics of the harmonics (Paragraph 0099; Paragraph 0052, “Another advantage of using this spectral range is the significant spectral characteristics of oxygenated and deoxygenated hemoglobin (O.sub.2Hb and HHb). Thus, in this area with high signal intensities, specifically the pulsation of the oxygenated and deoxygenated hemoglobin can be examined.”; Examiner notes that Applicant discusses that “a set of amplitude-phase characteristics” includes instantaneous spectrum, spectral density, or the like. Kulcke discloses the device uses this range due to the spectral characteristics of hemoglobin; thus, Kulcke reads on the limitation).
While Kulcke discusses having memory to store reference values (Paragraph 0104), Kulcke fails to explicitly disclose wherein the reference values correspond to hemoglobin concentrations.
However, Schweitzer teaches a method of spectrometric determination of oxygen saturation in the blood wherein spectral measurements are compared with known reference values of hemoglobin/oxyhemoglobin (Paragraph 0012). Schweitzer discusses this high-accuracy method is simple and fast. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulcke to incorporate the teachings of Schweitzer to measure hemoglobin in a simple and fast way.
Regarding claim 8, Kulcke further discloses wherein the most significant signal is characterized by the best signal-to-noise ratio, the highest amplitude, and/or the lowest noises (Paragraph 0048, wherein the pulse signal in the wavelength range of 570-585nm is clearer. Examiner interprets this to mean the signal has the lowest noise or best signal-to-noise ratio).
Regarding claim 9, Kulcke further teaches wherein the extraction of the harmonics from the reference signal comprises:
determining a coordinate of a fundamental harmonic; and
calculating coordinates of other harmonics (Paragraph 0182, wherein the fundamental frequency is determined and the harmonics are determined as integer multiples of the fundamental frequency; Fig. 10, fundamental frequency 25 and harmonics 27/29).
Regarding claim 19, Kulcke discloses wherein, in the describing of the PPG signals:
the most significant signal is selected from all the PPG signals and use it as a reference signal (Paragraph 0048, determining the wavelength in which the pulse signal is clearer),
the harmonics are extracted from the reference signal and are used as coordinates (Paragraph 0047; Fig. 10, fundamental frequency at 25, harmonic frequencies at 27/29), and
all the PPG signals are decomposed according to the coordinates (Paragraph 0099; Paragraph 0052, “Another advantage of using this spectral range is the significant spectral characteristics of oxygenated and deoxygenated hemoglobin (O.sub.2Hb and HHb). Thus, in this area with high signal intensities, specifically the pulsation of the oxygenated and deoxygenated hemoglobin can be examined.”; Examiner notes that Applicant discusses that “a set of amplitude-phase characteristics” includes instantaneous spectrum, spectral density, or the like. Kulcke discloses the device uses this range due to the spectral characteristics of hemoglobin; thus, Kulcke reads on the limitation).
While Kulcke discusses having memory to store reference values (Paragraph 0104), Kulcke fails to explicitly disclose wherein the reference values correspond to hemoglobin concentrations.
However, Schweitzer teaches a method of spectrometric determination of oxygen saturation in the blood wherein spectral measurements are compared with known reference values of hemoglobin/oxyhemoglobin (Paragraph 0012). Schweitzer discusses this high-accuracy method is simple and fast. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulcke to incorporate the teachings of Schweitzer to measure hemoglobin in a simple and fast way.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kulcke as applied to claim 1 above, and further in view of Baker (US 6411833).
Regarding claim 10, Kulcke discusses describing the PPG signals above to obtain a set of characteristics. Kulcke fails to explicitly disclose measuring parameters for each harmonic.
However, Baker teaches a method and apparatus for measuring physiological parameters such as a pulse oximeter, wherein the amplitudes of the harmonics are measured and discusses this is useful to determine the power of the harmonics with a minimal number of computations (Col 16, lines 54-59). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulcke to incorporate the teachings of Baker to reduce the number of computations when calculating the power of the harmonics.
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kulcke and Schweitzer as applied to claim 2 above, and further in view of Newberry (US 20180214088).
Regarding claim 11, Kulcke as modified discusses having a memory to store reference data as above. With regards to the limitations of claim 11 and 13, Kulcke as modified fails to explicitly disclose wherein the reference data includes data from other users and correlating hemoglobin concentrations to a laboratory method, updating the database, and revise an AI/ML algorithm.
However, Newberry teaches a PPG circuit wherein a database comprises information associated to a concentration level of a substance (Paragraph 0113), such as hemoglobin (Paragraph 0112). A method of enhancing a particular class of devices (methods, or products) has been made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in other situations. One of ordinary skill in the art would have been motivated to apply this known method of storing other user data in a database of Newberry to the device of Kulcke in the prior art and the results of using other user data for comparison would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulcke and Schweitzer to incorporate the teachings of Newberry.
Regarding claim 13, Newberry further teaches wherein:
correlate the hemoglobin concentration using a hemoglobin concentration value measured by the laboratory method (Paragraphs 0113 – 0115);
update the database (Paragraph 0130, storing in a database); and
revise the prediction algorithm using a machine learning algorithm or a neural network (Paragraphs 0242-243 and 273, wherein the neural network is updated based on the learning vector and inputs measured). Newberry discusses this is useful to create a personalized training set for the user and/or use as a global training set for other users (Paragraph 0272). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulcke and Schweitzer to incorporate the teachings of Newberry to create personalized or global training sets for users.
Claims 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kulcke as applied to claims 1 above, and further in view of Li (US 20140243612).
Regarding claim 14, Kulcke discloses an input/output devices (Paragraph 0084) and an output unit wherein data is transmitted to other devices (Paragraph 0128; Fig. 2, output unit 15) and displayed (Paragraph 0130). Kulcke fails to explicitly disclose wherein the device communicates with a remote server and/or cloud storage.
However, Li teaches a medical diagnostic instrument wherein the instrument communicates with a remote server to use the person’s historic data, population data from other users and knowledge of the characteristics of that device (Paragraph 0024). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulcke to incorporate the teachings of Li to use historic patient data.
Regarding claim 20, Kulcke discloses the device of claim 1 and a means of communicating with external devices (Paragraphs 0084 and 0128). Kulcke fails to explicitly disclose a remote server and/or a cloud storage.
However, Li teaches a medical diagnostic instrument wherein the instrument communicates with a remote server to use the person’s historic data, population data from other users and knowledge of the characteristics of that device (Paragraph 0024). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulcke to incorporate the teachings of Li to use historic patient data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791