DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of species B in the reply filed on 14 May 2026 is acknowledged.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1 and 4 are objected to because of the following informalities:
Claim 1 recites “the determined the deoxyhemoglobin blood content”; this is grammatically incorrect.
Claim 4 recites “determine a third AC-to-DC ratio for the third PPG”; as claim 1 already calls for determining this ratio, it appears this should refer to the third ratio.
Appropriate correction is required.
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, 14-16, 18-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “determine a fourth AC-to-DC ratio associated with deoxyhemoglobin blood content,… oxyhemoglobin blood content, … glycated hemoglobin blood content”. Given the lack of articles, it is entirely unclear if the intent is to use the various blood contents determined in the previous claim as part of how this additional ratio is determined, or, if not, it is unclear what it means for a ratio to be “associated” with various blood contents. The same is true of the additional fifth and sixth ratios recited in claim 2. This is also found in claim 18.
Further, it is unclear what this ratio might be or how it is determined or how it differs from the first determined ratio, when this fourth ratio does not specifically identify what signals are involved beyond it being “associated” with a number of parameters, where some of those parameters include parameters “corresponding to the first wavelength” where the first wavelength would be the wavelength used to obtain the first PPG signal and thereby the first ratio. The claim does not actually identify any signals involved in the finding of this ratio, only “associated” other parameters where it is equally unclear what this “association” is, whether the ratio is “associated” with them in that it uses these various parameters as inputs to the ratio or if the ratio itself is somehow representative of 6 different parameters. The same is true of the recited fifth and sixth ratios being “determined”; this issue is also found in claims 14 and 18.
Claim 2 recites “a first absorption constant for dexoyhemoglobin blood content corresponding to the first wavelength”; claim 1 already defines “absorption constants for deoxyhemoglobin blood content….”. It is unclear if this is one of the already defined constants or an additional constant; the same is true of the various other first, second, third constants recited in claim 2. This is also found in claims 14 and 18.
Claim 2 calls for the processing element to “determine, based on the six determined AC-to-DC ratios, the deoxyhemoglobin blood content, the oxyhemoglobin blood content and the glycated hemoglobin blood content.” Per claim 1, these blood contents are already determined using the first three ratios. It is entirely unclear if this is an additional determination, potentially producing different results, or if these ratios are used in addition to the ratios already recited, further refining the determination as performed in claim 1, or if the intent is to replace the determination of claim 1 with this different determination, which is not permissible. This is also found in claim 18.
Claim 19 recites “the differences including a region of the user’s skin each of the first optical signal, the second optical signal and the third optical signal pass”. This contains numerous issues – it is unclear if there is merely punctuation missing between “user’s skin” and “each of the first”, such that “a region of the user’s skin” is considered a difference, or if there are words or phrases missing that would define how these signals relate to the user’s skin. Further, it is unclear if “pass” is a typographical error or if the intent is to refer to how light passes through skin. Clarification is required.
Where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. See MPEP 2173.06. Claims 2, 14-16, 18-20 cannot be further treated on the merits.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 13 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 13 recites “wherein the housing and band secure the electronic device to an extremity of the user”; the human body cannot be claimed, and this should recite that the elements are configured to secure the device to the body. For the purposes of examination the claim will be treated as such but correction is required.
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, 3-7, 11-13, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huiku (US 2009/0024011) in view of Wong (US 2021/0000391).
Regarding claim 1, Huiku discloses an electronic device, comprising:
an optical transmitter array (element 10) operable to output a plurality of optical signals that pass through a user’s skin, the plurality of optical signals including a first optical signal having a first wavelength, a second optical signal having a second wavelength and a third optical signal having a third wavelength (paragraph [0088]);
an optical receiver (element 12) operable to receive the optical signals modulated by the skin of the user and generate first, second and third photoplethysmogram (PPG) signals resulting from the received first, the second and the third optical signals, respectively, the first optical signal, the second optical signal and the third optical signal each traveling substantially along the same path and each optical signal containing a cardiac component of the user (paragraph [0034]);
a memory element (element 16) configured to store absorption constants for a plurality of species of hemoglobin blood contents including deoxyhemoglobin blood content, oxyhemoglobin blood content, and blood content of other species of hemoglobin, each absorption constant associated with one of the first wavelength, the second wavelength or the third wavelength (paragraph [0047], [0088]); and
a processing element in electronic communication with the optical transmitter array and the optical receiver, the processing element configured to:
receive the first, the second and the third PPG signals from the optical receiver (paragraph [0034]),
determine a first AC-to-DC ratio for the first PPG signal (paragraph [0037]),
determine a second AC-to-DC ratio for the second PPG signal (paragraph [0037]),
determine a third AC-to-DC ratio for the third PPG signal (paragraph [0037]),
determine, based on the three determined AC-to-DC ratios, the deoxyhemoglobin blood content, the oxyhemoglobin blood content and the blood content of another species of hemoglobin, and
determine a blood level of the other species of hemoglobin for the user based on a ratio of the determined blood content of the other species of hemoglobin to a sum of the determined blood contents of the plurality of species of hemoglobin (paragraph [0088], [0114]).
Huiku does not disclose the hemoglobin species being glycated hemoglobin, and does not set forth specifics of the physical structure of the device including a housing including a bottom wall configured to contact the user’s skin with the optical transmitter array and optical receiver positioned in first and second locations on the bottom wall.
Wong teaches an electronic device, comprising:
a housing including a bottom wall configured to contact a user’s skin (element 100, figure 1);
an optical transmitter array positioned at a first location on the bottom wall and operable to output a plurality of optical signals of different wavelengths that pass through a user’s skin (elements 101);
an optical receiver positioned at a second location on the bottom wall and operable to receive the optical signals modulated by the skin of the user and generate photoplethysmogram (PPG) signals resulting from the received optical signals, respectively (elements 103), the optical signals each traveling substantially along the same path and each optical signal containing a cardiac component of the user (paragraphs [0071]-[0072]);
a memory element (element 211) configured to store absorption constants for glycated hemoglobin blood content and other blood contents, each absorption constant associated with a wavelength (paragraphs [0023]-[0024]); and
a processing element in electronic communication with the optical transmitter array and the optical receiver (element 209), the processing element configured to:
receive the PPG signals from the optical receiver and determine AC-to-DC ratios for each signal (paragraphs [0100]-[0103]),
determine, based on the determined AC-to-DC ratios, the glycated hemoglobin blood content, and determine a glycated hemoglobin blood level for the user based on a ratio of the determined glycated hemoglobin blood content to a sum of the total hemoglobin blood content (paragraphs [0021], [0028], [0161]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Huiku with a housing with the optical transmitter and receiver on its skin-contacting bottom surface, as taught by Wong, as Huiku does not set forth specifics of the system’s configuration, with the processor configured to find a glycated hemoglobin blood level by using ratios of a plurality of hemoglobin species, as also taught by Wong, as Huiku teaches finding a number of hemoglobin species and Wong teaches that glycated hemoglobin can be found using similar PPG techniques and a comparison of the relative responses at different appropriate wavelengths for any given desired analyte such as glycated hemoglobin.
Regarding claim 3, Huiku further discloses that the memory element is further configured to store a plurality of signal path factors, the plurality of signal path factors including a first signal path factor corresponding to the first wavelength, a second signal path factor corresponding to the second wavelength, and a third signal path factor corresponding to the third wavelength (paragraphs [0017]-[0018], [0040]-[0042], [0046]).
Regarding claim 4, Huiku further discloses that the processing element is further configured to determine the first AC-to-DC ratio for the first PPG signal based on the first signal path factor, determine the second AC-to-DC ratio for the second PPG signal based on the second signal path factor, and determine a third AC-to-DC ratio for the third PPG signal based on the third signal path factor (paragraphs [0040]-[0047], [0088]).
Regarding claim 5, Huiku further discloses that the optical transmitter array includes a first optical transmitter configured to transmit the first optical signal, a second optical transmitter configured to transmit the second optical signal and a third optical transmitter configured to transmit the third optical signal, and wherein the processing element is further configured to control the first optical transmitter to transmit the first optical signal during a first period of time, the second optical transmitter to transmit the second optical signal during a second period of time and the third optical transmitter to transmit the third optical signal during a third period of time (paragraph [0033]).
Regarding claim 6, Huiku further discloses that the processing element is further configured to control the optical transmitter array to transmit the first optical signal during a first period of time, the optical transmitter array to transmit the second optical signal during a second period of time and the optical transmitter array to transmit the third optical signal during a third period of time (paragraph [0032], “Each LED is illuminated in turn”).
Regarding claim 7, Huiku further discloses that the first period of time, the second period of time and the third period of time are in sequential order (paragraph [0032], “Each LED is illuminated in turn”).
Regarding claims 11 and 12, Huiku further discloses that the first wavelength is between 620 – 650 nm, the second wavelength is between 650 – 700 nm, and the third wavelength is between one of 760 nm – 860 nm and 900 nm – 1,000 nm (paragraphs [0032], [0047], [0073]-[0076], [0088]; Table 1).
Regarding claim 13, Wong further teaches the device further comprising a band, wherein the housing and band secure the electronic device to an extremity of the user (figure 1). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Huiku and Wong, further including a band which works with the housing to secure the device, as further taught by Wong, in order to ensure stable monitoring over time.
Regarding claim 17, Huiku discloses an electronic device, comprising:
an optical transmitter array (element 10) operable to output a plurality of optical signals that pass through a user’s skin, the plurality of optical signals including a first optical signal having a first wavelength, a second optical signal having a second wavelength and a third optical signal having a third wavelength (paragraph [0088]);
an optical receiver (element 12) operable to receive the optical signals modulated by the skin of the user and generate first, second and third photoplethysmogram (PPG) signals resulting from the received first, the second and the third optical signals, respectively, the first optical signal, the second optical signal and the third optical signal each traveling substantially along the same path and each optical signal containing a cardiac component of the user (paragraph [0034]);
a memory element (element 16) configured to store absorption constants for a plurality of species of hemoglobin blood contents including deoxyhemoglobin blood content, oxyhemoglobin blood content, and blood content of other species of hemoglobin, each absorption constant associated with one of the first wavelength, the second wavelength or the third wavelength (paragraph [0047], [0088]) and a plurality of signal path factors, the plurality of signal path factors including a first signal path factor corresponding to the first wavelength, a second signal path factor corresponding to the second wavelength, and a third signal path factor corresponding to the third wavelength (paragraphs [0017]-[0018], [0040]-[0042], [0046]); and
a processing element in electronic communication with the optical transmitter array and the optical receiver, the processing element configured to:
receive the first, the second and the third PPG signals from the optical receiver (paragraph [0034]),
determine a first AC-to-DC ratio for the first PPG signal (paragraph [0037]),
determine a second AC-to-DC ratio for the second PPG signal (paragraph [0037]),
determine a third AC-to-DC ratio for the third PPG signal (paragraph [0037]),
determine, based on the three determined AC-to-DC ratios, the deoxyhemoglobin blood content, the oxyhemoglobin blood content and the blood content of another species of hemoglobin, and
determine a blood level of the other species of hemoglobin for the user based on a ratio of the determined blood content of the other species of hemoglobin to a sum of the determined blood contents of the plurality of species of hemoglobin (paragraph [0088], [0114]).
Huiku does not disclose the hemoglobin species being glycated hemoglobin, and does not set forth specifics of the physical structure of the device including a housing including a bottom wall configured to contact the user’s skin with the optical transmitter array and optical receiver positioned in first and second locations on the bottom wall.
Wong teaches an electronic device, comprising:
a housing including a bottom wall configured to contact a user’s skin (element 100, figure 1);
an optical transmitter array positioned at a first location on the bottom wall and operable to output a plurality of optical signals of different wavelengths that pass through a user’s skin (elements 101);
an optical receiver positioned at a second location on the bottom wall and operable to receive the optical signals modulated by the skin of the user and generate photoplethysmogram (PPG) signals resulting from the received optical signals, respectively (elements 103), the optical signals each traveling substantially along the same path and each optical signal containing a cardiac component of the user (paragraphs [0071]-[0072]);
a memory element (element 211) configured to store absorption constants for glycated hemoglobin blood content and other blood contents, each absorption constant associated with a wavelength (paragraphs [0023]-[0024]); and
a processing element in electronic communication with the optical transmitter array and the optical receiver (element 209), the processing element configured to:
receive the PPG signals from the optical receiver and determine AC-to-DC ratios for each signal (paragraphs [0100]-[0103]),
determine, based on the determined AC-to-DC ratios, the glycated hemoglobin blood content, and determine a glycated hemoglobin blood level for the user based on a ratio of the determined glycated hemoglobin blood content to a sum of the total hemoglobin blood content (paragraphs [0021], [0028], [0161]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Huiku with a housing with the optical transmitter and receiver on its skin-contacting bottom surface, as taught by Wong, as Huiku does not set forth specifics of the system’s configuration, with the processor configured to find a glycated hemoglobin blood level by using ratios of a plurality of hemoglobin species, as also taught by Wong, as Huiku teaches finding a number of hemoglobin species and Wong teaches that glycated hemoglobin can be found using similar PPG techniques and a comparison of the relative responses at different appropriate wavelengths for any given desired analyte such as glycated hemoglobin.
Conclusion
No art has been applied against claims 2, 14-16, 18-20; however, as these claims are rejected under 112 above they are not presently allowable and the question of prior art will be revisited upon resolution of their scope.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 2024/0225495 to Kim, US 2024/0148282 to Kim, US 2020/0359939 to Aiyer, US 2011/0237911 to Lamego, US 2026/0165589 to Maddikatla, US 2025/0134464 to MacDonald, which disclose similar systems
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN E TOTH whose telephone number is (571)272-6824. The examiner can normally be reached Mon - Fri 9a-6p.
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.
/KAREN E TOTH/Examiner, Art Unit 3791
Prosecution Insights