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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) is acknowledged.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-7) in the reply filed on November 10, 2025 is acknowledged. Applicant also amended claim 17 to be dependent on claim 1 and added new claims 21-24 which depend from claim 17. Applicant asserts that claims 17-24 are now directed towards the elected embodiment and should be examined together. Applicant cites par. 0008, 0009, and 0050 as support for the amended and new claims. However, examiner cannot find support in the cited paragraphs or elsewhere in the specification for the amendments. Specifically, there is only teaching “computing a heart rate” based on the rate of change of pixel intensity in par. 0123 which is verbatim to the original independent claim 17. While there is teaching of determining the PPG or BCG waveforms elsewhere in the specification, these are not the same as “heart rate”. Further, it is not found in the disclosure where “heart rate” and “pulse transit time” (PTT) are monitored together, as would be required by the amended claim 17 (in combination with claim 1). Being directed towards measuring “heart rate” appears to be the non-elected embodiment, which one of ordinary skill would recognize requires distinct signal processing differences from PTT. As such, Examiner withdraws claims 8-15, 17-24 as being directed towards the non-elected embodiments. If claim 17 is amended to be consistent with the elected embodiment, Examiner will reconsider for rejoinder. The restriction requirement is hereby made final.
Claim Interpretation
For claim interpretation of “patch coupled to the patient” (claim 1), it is considered to be a physical patch, e.g. the patches as shown in Figures 5A, 5B, 5C, which is the broadest reasonable interpretation in light of the disclosure. In this art, the term “patch” can sometimes be referring to a region of interest that is defined virtually. Here, a virtual patch is not considered to read on the claim limitation.
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 1-3, 6 are 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.
Regarding Claim 1, the claim require measurement at “a capture point” and comparison of a first set of images and second set of images obtained at the capture point to determine pulse transmit time (PTT). However, PTT by definition is measuring the time is takes for blood to travel between two locations, typically a proximal upstream location (e.g. heart, aorta) and a distal/downstream peripheral location (e.g. finger). PTT cannot be measured from a single location; rather, it is measured from information obtained at two (or more) locations. Then the delay between the two (or more) locations determines the PTT. The disclosure acknowledges this (par. 0041): “The various measurements at different capture points and combinations of BCG and PPG may be used to calculate PTT. That is, the two or more capture points used to calculate PPT may use PPG to PPG, BCG to PPG, PPG to BCG, or BCG to BCG measurements.”
As claimed, only one capture point is required and PTT is determined based on the change in pixel intensity at the one capture point. As such, while possession is shown for obtaining BCG or PPG waveforms at two different capture points and determining PTT, possession is not shown for determining BCG or PPG waveforms at the same capture point and determining PTT. Both these scenarios are included in the scope of the claim. As such, Applicant has not demonstrated possession for the full scope of the claimed invention.
During examination, it is assumed that two capture points are required for determining the PTT, consistent with the specification and understanding of one of ordinary skill in the art. However, it is not assumed that each capture point requires a patch. For purposes of examination, at least one of the capture points has a patch but not necessarily both.
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 1-3, 6 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 1, the preamble states it is a method for “continuous blood pressure monitoring”. However, none of the steps recited monitor or otherwise determine blood pressure. As such, the scope of the claim is confusing. During examination, it is assumed the computed pulse transit time is subsequently used to calculate blood pressure.
Claims 2-3 and 6 are rejected by virtue of their dependency on a rejected claim.
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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over US 20140221847 to Dubielczyk in view of US 20160278644 to He.
Regarding Claim 1, Dubielczyk teaches a method for continuous blood pressure monitoring (the monitored vital sign is blood pressure, par. 0021, and monitored continuously over time, par. 0022) comprising:
receiving, by a computing device, a first set of images of a patient acquired using an imaging device (camera 22 receives a first set of images 26, 27 at a first timepoint, Figure 2, and passes the image information to a computer/image processing unit 4, Figure 1, par. 0031);
receiving, by the computing device (image processing unit 4/analysis unit 6, Figure 1), a second set of images of the patient acquired using the imaging device (camera 22 receives a second set of images 26, 27 at a second timepoint, Figure 2, and passes the image information to a computer/image processing unit 4, Figure 1, par. 0031);
identifying, by the computing device (image processing unit 4/analysis unit 6, Figure 1), a capture point visible in the first set of images and the second set of images, wherein the capture point comprises a patch coupled to the patient (the image processing unit 4 locates the patch marker in the images/video, par. 0031);
computing, by the computing device (image processing unit 4/analysis unit 6, Figure 1), a change in the patch between the first set of images and the second set of images, wherein the change is a change in pixel intensity (waveforms 28, 29 represent changes in pixel intensity over time, par. 0060; the light from the surface of the patch (C, B) is used as an offset while the light that transmits through the patch (A, D) is used as the time-variant signal, par. 0061, Figure 2); and
computing, based on the change in pixel intensity, a photoplethysmography signal (PPG, par. 0064-0065, waveforms 28, 29, Figure 2).
Although Dubielczyk teaches the detected signal may be used to monitor blood pressure (par. 0021) and shows two patches at separate locations (Figure 1, marker patches 10 and 10’), Dubielczyk does not expressly teach wherein the PPG signal is utilized to compute pulse transit time.
He teaches how to convert PPG signals into a pulse transit time for contactless blood pressure measurement. Specifically, two locations are monitored with a camera to obtain a time-variant signal/waveform at each location (step 404, 406, Figure 4). A representative point is designated in the first waveform and compared to the same point in the second waveform (408, 410, Figure 4). The time difference between the two points is the PTT (412, Figure 4; graphically showed by 115a, 115b, 115c in Figure 1A). Blood pressure is then determined as a function of PTT (par. 0037).
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to utilize the PPG signals from the two locations measured by Dubielczyk (Figure 1, marker patches 10 and 10’) to compute PTT as taught by He in order to compute the blood pressure vital sign suggested by Dubielczyk (par. 0021) and taught expressly by He.
Regarding Claim 2, Dubielczyk further teaches wherein the change in the pixel intensity indicates a volumetric change of blood at a skin surface of the patient in response to a heartbeat (definition of a plethysmograph signal relies on volume changes of blood due to the pulsatile nature within the blood vessel close to the skin surface where the measurement occurs, par. 0004; blood vessels 105 close to the skin surface 104, Figure 2).
Regarding Claim 3, Dubielczyk further teaches wherein the patient is illuminated during acquisition of the first or second set of images (illumination sources 7a, 7b, 7c, Figure 1 can include sunlight, ambient light, or light source of a specific wavelength, par. 0055 and is illuminated during acquisition, par. 0058).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US 20140221847 to Dubielczyk in view of US 20160278644 to He, as applied to claim 1 above, in further view of US 20190274547 to Ekin.
Regarding Claim 6, Dubielczyk teaches wherein the patch is reflective (e.g. rays C, B in Figure 2) but does not teach wherein the patch is retroreflective.
Ekin teaches noncontact vital signs monitoring where a reflective patch is utilized to increase the power of the reflected signal, in particularly by using retroreflective surfaces (par. 0030).
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to utilize the retroreflective patch surface of Ekin in the system of Dubielczyk in order to increase the power of the reflected signal. Ekin additionally teaches advantages of the power boost include using the reflected signal for measurement of additional vital signs (e.g. heartrate, respiration) due to body movements (e.g. chest movements as in Figure 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 10398353 to Addison teaches non-contact PPG using virtual “patches”. US 20170209053, 20230293028, 11589758, 12239424 to Pantelopoulos teaches PTT calculations using PPG measured from two locations (Figure 1A). US 20170202463 to Muhlsteff teaches combined PPG and BCG measurements. US 20140253709 to Bresch teaches non-contact PPG for vital sign measurement and uses adhesive patches to mark the measurement site. US 20140243648 to Dubielczyk teaches non-contact PPG and marker patch at the measurement site. US 20150366455, US 9980650 to Bezemer teaches a measurement patch for non-contact PPG (Figure 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
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, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799