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
In response to election restriction requirement of 03/16/2026, applicant elected group I without traverse and species 2 with traverse. The traversal in not persuasive for the following reasons.
Applicant argues on pages 9-10
“To establish that a different field of search exists, the Restriction Requirement must show "it is necessary to search for one of the inventions in a manner that is not likely to result in finding art pertinent to the other invention(s)." MPEP 808.02. However, this is not the case here. Indeed, each of species 1-4 are directed to computing or refining diastolic blood pressure measurements based on PPG oscillation width. Accordingly, Applicant respectfully submits that related searches are likely to result in finding art pertinent to each species”
Examiner respectfully disagrees. Examiner has noted in the Office action pages 6-7 that invention require different field of search. For e.g. area to height function, is not required in other species. The features recited in other species, are not required in claim 4. The other species requires additional searching using terms (as well as combinations of terms) for bending, R-waves, slope, pulse arrival time. The application spec. for e.g. pages 13-14, expressly recited these as different schemes to determine width, of which area-to-heigh method is one among them.
In view of this, claims 1, 4, 7, 25 are examined. Claims 2-3, 5-6, 8-24 are considered withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 7, 25 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “computing a width…” in line 8. There is lack of written description for computing width using the elected embodiment. Claim 4 directed to elected species claims “wherein the width of each PPG oscillation is computed as an area-to-height ratio of the oscillation” This is discussed also in application spec. pages 13-14. However, an area is defined as area between trough to trough. Here trough to trough means time period or delay or interval, which is the width of each pulse in a PPG. Hence, the area (and hence area-to-height ratio) requires the width of each oscillations to be known. However, this is the unknown that is claimed, and that is to be computed. Applicant does not describe how the area can be computed, if width is not known, and if width is to be computed later after area is computed. Examiner’s analysis of the spec. does not find any further explanation regarding this. Examiners search for the term does not find any prior art reference expressly discussing about “area-to-height” in ppg applications (See additional documents in PTO 892 discussing areas and heights). The claimed computation of width, using an area-to-height ratio, is not described in the spec. and examiner cannot find any record discussing how this, if previously known, was implemented. For examination purpose, examiner interprets as using some beats or intervals for ppg analysis.
Claims 4, 7, 25 recites or encompass similar limitation and are rejected for same reasons.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4, 7, 25 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.
The lack of written description to claim 1, 4, 7, 25 as discussed above, make the claim indefinite. Claim 4 is further rejected under 112 (b) because the term is indefinite for examination. For examination purpose, examiner interprets as using beats or intervals for ppg.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 7 rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by Mukkamala [US 20190008399 A1].
As per claim 1, Mukkamala teaches method for determining diastolic blood pressure of a user (Mukkamala Fig 1, ¶0042)
using a device with a photoplethysmography (PPG)-force sensor unit (Mukkamala abstract “reflectance-mode photo-plethysmography-force sensor unit”, Fig 1 Fig 3 item 108) comprising:
providing visual or audio instructions to the user with the device (Mukkamala ¶0041 “The mobile device provides visual guidance for proper finger actuation”),
wherein the instructions instruct the user to position a finger on the PPG-force sensor unit (Mukkamala Fig 4, steps 212 to 220) and
to press the finger on the PPG-force sensor unit at varying finger pressures (Mukkamala Fig 4, steps 216 to 220);
measuring PPG oscillations of the finger and the finger pressures with the PPG-force sensor unit (Mukkamala Fig 2C the plot between oscillations and pressure requires measurements );
computing a width of each of the PPG oscillations (Mukkamala ¶0047 “an oscillogram is constructed by first taking a maximum value and a minimum value of each beat…”. The term “each beat” means that width (time / period) of each of the ppg oscillations are identified (i.e. inherently computed and utilized))
as a function of the finger pressure (Mukkamala ¶0047 “The maximum value and minimum value of each beat, as a function of the pressure applied 116 to the sensing unit 108 …”);
computing diastolic blood pressure using the PPG oscillation width versus finger pressure function (Mukkamala ¶0047 “The maximum value and minimum value of each beat, as a function of the pressure applied 116 to the sensing unit 108 …” ¶0062 “the system determines the SP and DP based on the blood volume oscillations and the pressure applied 116 to the sensing unit 108” DP is computed using Fig 2C, and further algorithms); and
outputting the diastolic blood pressure on a graphical user interface of the device or sending the diastolic blood pressure to a database repository (Mukkamala Fig 1, ¶0042, item 124).
As per claim 7, Mukkamala further teaches wherein the diastolic blood pressure is computed using additional features extracted from the PPG oscillations and finger pressure (Mukkamala ¶0070 “DP 348 are estimated as the pressure at which the oscillogram is a fixed, population based average ratio of its maximal value”, these are additional features. Further, ¶0050 “Example algorithms that may be used in estimating BP are the Standard Fixed-Ratio Algorithm, the Fixed-Slope Algorithm, a Patient-Specific Algorithm, and other variations of these algorithms. These algorithms may also be combined in various manners to estimate BP.” These algorithms comprise additional features, like slope, ratio, etc.).
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 25 rejected under 35 U.S.C. 103 as being unpatentable over Mukkamala as applied to claim 1 above, and further in view of Moon [US 20180042495 A1].
As per claim 25, Mukkamala has limitations similar to claim 1 and are rejected for same reasons as above. Mukkamala further teaches a system for determining blood pressure of a subject comprising sensors configured to measure finger pressure, a finger photoplethysmography (PPG) oscillation (Mukkamala Fig 3 sensor inside 108), Mukkamala Fig 1, 3 item 104); and a processor configured to: compute DP and SP (Mukkamala Fig 3 item 300),
Mukkamala does not expressly teach sensors configured to measure finger PPG DC component, and ECG and wherein the systolic blood pressure is calculated using a PPG average.
Moon, in a related field of monitoring vital signs, teaches
sensors configured to measure finger PPG DC component (Moon ¶0067 “Both waveforms feature AC signals corresponding to the time-dependent pulsating blood, and DC signals corresponding to time-independent scattering off the skin 24”), and
ECG (Moon ¶0074 “ pulse oximeter system described above is integrated into a complete, body-worn monitoring system, shown in FIGS. 23A and 23B, that measures and analyzes ECG,”) and
wherein the systolic blood pressure is calculated using a PPG average (Moon ¶0008 ¶0072 “PTT values are processed over a 20-40 second time period (often implemented as a ‘rolling average’) using statistical filtering to improve accuracy”).
Hence these limitations are well known in the field of pulse oximetry. In the instant claim, there is no explicit use for the additional sensors recited and hence it could have been utilized for additional sensing. Hence Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Mukkamala, by adding sensors so as to monitor for SPO2. Further, Moon discusses the advantage for the rolling averaging is to improve accuracy. Hence it would have been obvious to utilize this in related applications like blood pressure monitoring uses ppg, so as to improve accuracy of calculations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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, ANNE M KOZAK can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Oommen Jacob/ Primary Examiner, Art Unit 3797
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