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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1-15 are objected to because of the following informalities: the claims recite an acronym (“PPG”) without providing the full expanded definition at the first usage. Appropriate correction is required.
Applicant is advised that should claim 1 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because “a computer program comprising computer program means” is software per se and is therefore not one of the four statutory categories of invention. See MPEP 2106.03.
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 8-9 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 claims 8 and 9, the phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of further examination, the limitations in claims 8 and 9 that follow the phrase “such as” will be interpreted to be merely examples of the type of elements that could be used.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 4, 6-7, 9-10, 12, and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu (US 2020/0383591 A1, Dec. 10, 2020) (hereinafter “Liu”) as evidenced by Lu, Xiaoqi, et al. "Study on non-rigid medical image registration based on optical flow model." 2012 International Workshop on Image Processing and Optical Engineering. Vol. 8335. SPIE, 2011 (hereinafter “Lu”).
Regarding claims 1, 12, 14, and 15: Liu discloses an adapted processor ([0094]), a “computer program product comprising computer program code means” ([0089], [0093]), and a method comprising: receiving images of a region of interest ([0045], step 101); identifying landmarks in each of a set of the images ([0047]); for pairs of the images of the set: pairing the landmarks between a first image of the pair and a second image of the pair ([0047] - "frame-by-frame");and deforming said second image of the pair to match the landmarks in that second image of the pair with the landmarks in the first image of the pair thereby providing motion compensation between said first and second images ([0047] - optical flow; while Liu does not describe registration via optical flow in detail, registration via optical flow includes each element of this limitation as evidenced by section 4 of Lu); and deriving a remote PPG signal from a set of the motion-compensated images ([0046] - pulse wave measurement; [0003], [0060] - where pulse wave measurement is disclosed as being performed using PPGi, or PPG imaging, which the instant disclosure defines as being remote PPG).
Regarding claim 4: Liu discloses the processor of claim 1, wherein the images comprise 2D camera images (images shown in figs. 4a-c are 2D, and infrared images are described as being 2D in [0051]).
Regarding claim 6: Liu discloses the processor of claim 1, wherein the landmarks comprise a pattern of a microvasculature visible at the surface of the region of interest ([0046] - "vein pattern").
Regarding claim 7: Liu discloses the processor of claim 6, wherein the pattern of microvasculature is encoded as branch points and/or vessel lengths ([0046] - "vein pattern"; the vasculature, including branch points and the visible length of vessels, are included or "encoded" in the images, see e.g. the image frames in fig. 4a).
Regarding claim 9: Liu discloses the processor of claim 1, adapted to deform the second image of the pair by using an algorithm that combines image registration and deformation, such as a Free Form Deformation algorithm or a Thin Plate Spines algorithm ([0047] - optical flow, as evidenced by section 4 of Lu).
Regarding claim 10: Liu discloses a system comprising a processor of claim 1, and an image camera for capturing the images of the region of interest (fig. 5, [0089]-[0090]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 2-3 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of LAI, Marco (PR-TN2016/00448,"Perfusion monitoring by non-contact photoplethysmographic (PPG ) imaging", 2017) (hereinafter “Lai”).
Regarding claims 2-3 and 13: Liu discloses the processor and method of claims 1 and 12, but is silent on wherein the set of PPG signals comprise a PPG perfusion map based on PPG amplitude levels obtained from the motion-compensated images at a set of image locations or wherein the set of PPG signals comprise a PPG delay map based on PPG relative delays between image locations.
Lai, in the same field of endeavor, discloses providing a set of PPG signals as a PPG perfusion map based on PPG amplitude levels obtained from the images at locations corresponding to the pixels of each image (the representation of the patient’s tissue) (3.4.2 Lock-in Amplification method; 3.5 The PPG Map) and providing the set of PPG signals as a PPG delay map based on PPG relative delays between different locations at locations corresponding to the pixels of each image (the representation of the patient’s tissue) (3.4.2 Lock-in Amplification method; 3.5 The PPG Map).
Lai further discloses that perfusion mapping, including amplitude and phase ("delay") mapping, are well-known and conventional in the art (1.3.4 Non-contact PPG imaging) and that the use of such perfusion monitoring may have the potential to significantly improve patients’ lives (1.3.2 Why measure perfusion).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the processor and method of Liu to include providing perfusion maps corresponding to the representation of the patient’s tissue as taught by Lai in order to improve patient care by the application of a conventional monitoring technique in view of the further teachings of Lai.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Fan et al. (US 2020/0138360 A1, May 7, 2020) (hereinafter “Fan”).
Regarding claim 5: Liu discloses the processor of claim 1, but does not disclose wherein the images comprise hyperspectral camera images.
Fan, in the same field of endeavor, discloses a method of tissue evaluation which uses both multi-spectral (including hyperspectral – [0093]) and PPG images ([0091] – data set 410 comprises both PPG images and multi-spectral/hyperspectral images). Fan further teaches that the use of this combined image data allows one to gain significant physiological information allowing a clinician to rapidly assess tissue viability and features such as blood perfusion and oxygenation at a tissue site ([0088]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to use combined imaging data comprising both PPG and hyperspectral images in order to allow rapid assessment of tissue viability, perfusion, and oxygenation in view of the further teachings of Fan.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Voegele et al. (US 5,941,890, Aug. 24, 1999) (hereinafter “Voegele”).
Regarding claim 8: Liu discloses the processor of claim 1, but is silent on wherein the landmarks comprise applied surgical features such as staples or sutures.
Voegele discloses that various types of markers, including surgically applied features, are well-known and conventional (column 2, lines 20-55; column 3, lines 30-40).
Based on the teachings of Voegele that many types of marker, including surgically applied features, may be used as landmarks and that such markers are conventional and well-known, it would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to make use of any type of surgically applied feature which may be present in the ROI as a landmark in order to provide a reliable and consistent point of reference.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Elhawary et al. (US 2015/0164592 A1, Jun. 18, 2015) (hereinafter “Elhawary”).
Levi discloses the system of claim 9, but is silent on endoscope, wherein the image camera is mounted at a distal end of the endoscope or at the proximal end of the endoscope.
Elhawary, in the same problem solving area of PPG perfusion monitoring, teaches a system comprising an endoscope with a camera mounted at a distal end of the endoscope ([0028]). Elhawary further teaches that endoscopic PPG can be used during a surgical procedure, such as cardiac bypass, in order to evaluate the success of the procedure ([0021], [0032]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Liu by implementing the system as an endoscopic system as taught by Elhawary in order to in order to provide motion corrected images for PPG analysis for delicate surgical procedures such as beating-heart cardiac in view of the teachings of Elhawary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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/CAROLYN A PEHLKE/ Primary Examiner, Art Unit 3799