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 .
Claim Objections
Claims 30, 33, 40, 44 and 53 are objected to because of the following informalities: the claims are referring back to claim “0”. Appropriate correction is required.
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.
35 U.S.C. 101 requires that a claimed invention must fall within one of the four eligible categories of invention (i.e. process, machine, manufacture, or composition of matter) and must not be directed to subject matter encompassing a judicially recognized exception as interpreted by the courts. MPEP 2106. Three categories of subject matter are found to be judicially recognized exceptions to 35 U.S.C. § 101 (i.e. patent ineligible) (1) laws of nature, (2) physical phenomena, and (3) abstract ideas. MPEP 2106(II). To be patent-eligible, a claim directed to a judicial exception must as whole be directed to significantly more than the exception itself. See 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 Fed. Reg. 74618, 74624 (Dec. 16, 2014). Hence, the claim must describe a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception. Id
Claims 1-5, 12, 16, 29, 30, 40 and 44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more. Claims 1 and 29 are directed to gathering data, determining perfusion area on the data and comparing perfusion of image data with reference data, without additional elements that are sufficient to amount to significantly more than the judicial exception. Specifically, claim 1 recites obtaining an image, as gathering data under insignificant Extra-solution activity specifically a pre-solution activity; determine one or more perfusion characteristics associated with one or more reference regions, referring to mental process of visual determination under mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III); and further determining one or more relative perfusion characteristics for a target region, in the surgical scene based on ratio of one or more perfusion characteristics of the target region to the one or more perfusion characteristics associated with the one or more reference regions, as further referring to mental process of determining perfusion characteristic of images, based on gathered ratio data by mathematical process. Therefore, claim 1 meets Step 2A, Prong one for including abstract idea.
The claim is further evaluated under Step 2A, Prong two for reciting additional elements that integrate the judicial exception into practical application. The limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:
• An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
• Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
• Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
• Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
• Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
Based on the above conditions, the Examiner is unable to determine that the claim is qualified under any one or more of the conditions. Therefore, the claim 1 fails Step 2A, Prong Two, for reciting a practical application.
Finally, the claim is considered under step 2B for including one or more additional elements that amount to significantly more than the judicial exception. Some the limitations that the courts have found to qualify as "significantly more" when recited in a claim with a judicial exception include:
i. Improvements to the functioning of a computer, e.g., a modification of conventional Internet hyperlink protocol to dynamically produce a dual-source hybrid webpage, as discussed in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014) (see MPEP § 2106.05(a));
ii. Improvements to any other technology or technical field, e.g., a modification of conventional rubber-molding processes to utilize a thermocouple inside the mold to constantly monitor the temperature and thus reduce under- and over-curing problems common in the art, as discussed in Diamond v. Diehr, 450 U.S. 175, 191-92, 209 USPQ 1, 10 (1981) (see MPEP § 2106.05(a));
iii. Applying the judicial exception with, or by use of, a particular machine, e.g., a Fourdrinier machine (which is understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls) that is arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web, as discussed in Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65 (1923) (see MPEP § 2106.05(b));
iv. Effecting a transformation or reduction of a particular article to a different state or thing, e.g., a process that transforms raw, uncured synthetic rubber into precision-molded synthetic rubber products, as discussed in Diehr, 450 U.S. at 184, 209 USPQ at 21 (see MPEP § 2106.05(c));
v. Adding a specific limitation other than what is well-understood, routine, conventional activity in the field, or adding unconventional steps that confine the claim to a particular useful application, e.g., a non-conventional and non-generic arrangement of various computer components for filtering Internet content, as discussed in BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. 2016) (see MPEP § 2106.05(d)); or
vi. Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment, e.g., an immunization step that integrates an abstract idea of data comparison into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases, as discussed in Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057, 1066-68, 100 USPQ2d 1492, 1499-1502 (Fed. Cir. 2011) (see MPEP § 2106.05(e)).
Based on the above citations, the Examiner is unable to determine the additional element in the claim that amounts to significantly more. Therefore, claim 1 fails Step 2B and therefore, not eligible under 101.
Similar assessments are made to the corresponding system claim 29 except that the claim recites a processor and storage medium. Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection. In the instant case, the computer retrieves stored data and displays plurality of the gathered data for determination by the operator. The processor and the storage of the claim does not but ordinary function of a computer and therefore, the combination does not make up a particular machine because a conventional computer function does not qualify as a particular machine (MPEP 2106.05(b)(I)). Therefore, claim 29 is not eligible under 101.
Regarding claims 2 and 30, the claim is reciting distinguishing an etiology of tissue ischemia based on visual observation under mental process and therefore, the claim is not eligible under 101.
Regarding claims 3 and 4, the claims are reciting further comparing of gathered images including a negative/positive representation of an image, under mental process and therefore, the claims are not eligible under 101.
Regarding claims 5 and 33, the claims reciting using a linear relationship between the one or more reference regions to determine the one or more relative perfusion characteristics, referring to visual observation, analysis and judgment under mental process and therefore the claims are not eligible under 101.
Regarding claims 12, 16, 40 and 44, the claims reciting the at least one image comprises at least one member selected from the group consisting of: a laser speckle image, a time-of-flight image, one or more multispectral and a fluorescence image, referring to additional types of gathered data under insignificant Extra-solution activity and therefore, the claims are not eligible.
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.
(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, 2, 4, 5, 29, 30 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9610021 B2 to Dvorsky et al (hereinafter ‘Dvorsky’).
Regarding claim 1, Dvorsky discloses a method for quantifying perfusion (column 2, lines 60-61, wherein a method for determining perfusion in myocardial tissue using fluorescence imaging), comprising: (a) obtaining at least one image of a surgical scene (column 5, lines 32-33, wherein FIG. 2 shows a typical ICG fluorescent image of a heart showing blood vessels and myocardial tissue); (b) processing the at least one image to determine one or more perfusion characteristics associated with one or more reference regions in the surgical scene (column 2, lines 60-67, and column 6, lines 67 through column 7, lin4wherein a method for determining perfusion in myocardial tissue using fluorescence imaging, includes the steps of defining a static region of interest (ROI) in an image of the myocardial tissue, measuring fluorescence intensity values of image elements (pixels) located within the ROI, and determining a blush value, as one of the perfusion characteristics, from an average of the intensity values of image elements, and wherein two approaches are proposed for comparing image data obtained before and after the procedure: (1) comparing the blush and washout rates before and after the procedure; and (2) comparing the elapsed time from blood vessel peak intensity to maximum blush on images taken before, as image including reference regions, and after the procedure.); and (c) determining one or more relative perfusion characteristics for a target region in the surgical scene based on ratio of one or more perfusion characteristics of the target region (column 7, lines 11-12, wherein the average intensity of the blush, as the ratio of perfusion characteristic, is then determined in each of, or in a subset of, the fluorescence images) to the one or more perfusion characteristics associated with the one or more reference regions (column 6, line 66 through column 7, line 1 and lines 5-11, wherein two approaches are proposed for comparing image data obtained before and after the procedure: (1) comparing the blush and washout rates, both as the perfusion characteristics, before and after the procedure, and wherein with the first approach, a time series of fluorescence images of the anatomy is acquired before (top image of FIG. 7), as the reference image, and after the surgical procedure (bottom image of FIG. 7), as the target image, by, for example, injecting a bolus of ICG dye. Only one of the time series of images is shown. A ROI is delineated in each of the images in approximately the same area of the anatomy.).
Regarding claim 2, Dvorsky discloses the method further comprising distinguishing an etiology of tissue ischemia as an inflow obstruction or an outflow obstruction based on the one or more relative perfusion characteristics (column 9, lines 54-59, wherein WRout=I′Out-Post/I′Out-Pre, as another ratio of characteristics. WRIn and WROut, as another perfusion characteristics, will be close to 1.0 in cases with normal vascular conditions. WRIn will be significantly less than 1.0 in cases of arterial spasm or partial arterial occlusion. This metric will vary inversely to the degree of arterial spasm or partial arterial occlusion).
Regarding claim 4, Dvorsky discloses wherein at least one of the reference regions is used as positive representing perfused reference region (column 7, lines 5-11, wherein with the first approach, a time series of fluorescence images of the anatomy is acquired before (top image of FIG. 7), as the positive perfused representing image, and after the surgical procedure (bottom image of FIG. 7)).
Regarding claim 5, Dvorsky discloses wherein (b) further comprises using a linear relationship between the one or more reference regions to determine the one or more relative perfusion characteristics (column 6, lines 32-36, wherein the maximum blush is approximately 112 [arb. units], the blush rate measured over about 6.1 sec from about zero blush to about the maximum value is in linear approximation about 16.2 [arb. units]/sec, and the washout rate measured over about 6.1 sec from about the maximum blush value to about 15-20% blush is in linear approximation about 10.5 [arb. units]/sec.).
Regarding claim 29, Dvorsky discloses a system for medical imaging, the system comprising: a processor operably connected to a non-transitory computer readable storage medium with instructions stored thereon (Fig. 1, system 11, inherently a computer to capture image data and processing them), wherein the processor is configured to implement the instructions to: (Please refer t the corresponding method claim above for further teachings).
Regarding claims 30 and 33, please refer to the corresponding method claims 2 and 5 above for further teachings.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Dvorsky in view of US 2021/0282654 A1 to CHA et al (hereinafter ‘Cha’).
Regarding claim 3, Dvorsky does not specifically disclose wherein at least one of the reference regions is used as negative representing in ischemic reference region. Cha discloses at least one of the reference regions is used as negative representing in ischemic reference region (Para [0119], wherein the system described herein distinguishes between normal and ischemic tissues before early changes in tissue color fully developed. In this experiment, clamps to halt flow in a section of small bowel are used (as shown in FIG. 15). Images were taken before clamping the mesentery vessel, 5 seconds after clamping, as the ischemic negative reference region, and 5 seconds after releasing the clamp. When observing purely color images, there are no visual differences between clamped and unclamped tissues. However, LSCI-processed images reveal obvious differences in flow. Vessels highlighted in the laser-speckle overlaid images 1502 shown in FIG. 15 are no longer highlighted during occlusion in image 1504, and a broad decrease in blue hue outside of vessels indicates a widespread decrease in perfusion across the occluded tissue). Dvorsky and Cha are combinable because they both disclose tissue perfusion determination. Therefore, before the effective filing data of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the reference regions is used as negative representing in ischemic reference region, of Cha’s method with Dvorsky’s so that distinguish between visual image differences between clamped and unclamped tissues, and LSCI-processed images (Para [0119]).
Claims 6 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Dvorsky in view of US 2023/0359057 A1 to DIJKSTRAR et al (hereinafter ‘Dijkstrar’)
Regarding claims 6 and 34, Dvorsky does not specifically disclose wherein the linear relationship relates a laser speckle contrast value to the one or more relative perfusion characteristics. Dijkstrar discloses wherein the linear relationship relates a laser speckle contrast value to the one or more relative perfusion characteristics (Para [0272-0273], wherein as speckle contrast is inversely correlated with perfusion, speckle contrast-based perfusion units could similarly be used. Preferably, the images may be normalized in such a way that the relation between the speckle contrast and weight is a linear with a constant.). Dvorsky and Dijkstrar are combinable because they both disclose tissue perfusion determination. Therefore, before the effective filing data of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the reference regions is used as negative representing in ischemic reference region, of Dijkstrar’s method/system with Dvorsky’s because using weights based on speckle contrast, a higher quality combined image may be obtained (Para [0272]).
Claims 8, 9, 16, 36, 37 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Dvorsky in view of US 11,395,590 B2 to Harmelin et al (hereinafter ‘Harmelin’).
Regarding claims 8 and 36, Dvorsky does not specifically disclose the method further comprising differentiating between the one or more reference regions based at least in part on pulsatility behavior referenced numbers. Harmelin discloses differentiating between the one or more reference regions based at least in part on pulsatility behavior referenced numbers (column 22, lines 32-36, and column 22 line 63 through column 23 line 4, wherein contrast of a laser speckle image is inversely proportional to a level of perfusion. In such embodiments, the contrast of an image with low perfusion is potentially high, and occluded blood vessels having low perfusion may be visualized, and wherein the graph 520 has an X-axis 522 showing time in units of seconds, and a Y-axis 521 showing laser speckle intensity in arbitrary, or relative, units. The graph 520 depicts a line 523 which demonstrates a change in speckle intensity, which corresponds to a change in an amount of blood which diffuses the laser speckles 1, and which corresponds to demonstrating a pulse rate of approximately 3 times per second, or a pulse rate of 180 per minute, as capturing signals based on pulsatility). Dvorsky and Harmelin are combinable because they both disclose tissue perfusion determination. Therefore, before the effective filing data of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the differentiating between the one or more reference regions based at least in part on pulsatility behavior referenced numbers, of Harmelin’s method/system with Dvorsky’s because when the laser used is of a wavelength which interacts with blood, a change in blood flow caused by the pulse can cause the blood vessels to appear enhanced (column 9, lines 5-8).
Regarding claim 9 and 37, in the combination of Dvorsky and Harmelin, Harmelin further discloses wherein the differentiating is based at least in part on one or more colormaps comprising laser speckle data (column 18, lines 16-26, wherein an aspect of the present invention includes in vivo transcranial imaging of cortical blood vessels in mice which combines laser speckle imaging, fluorescent angiography and optionally displaying results via an IHS color model. TOVI enables a snapshotting of cortical hemodynamics, and provides potentially quickly panoramic views and dynamic color-mapped images of the functional cerebral vasculature, optionally without removing bone. These features potentially enable a rapid and accurate assessment of blood flow and perfusion in areas of the brain or in specific major or minor arteries and veins.).
Regarding claims 16 and 44, Dvorsky discloses a fluorescence image however, Dvorsky does not specifically disclose at least one image comprises at least a laser speckle image and at least one image of a second image type, wherein the second image type is selected from the group consisting of: a time-of-flight image, one or more multispectral images, and a fluorescence image. Harmelin discloses at least one image comprises at least a laser speckle image and at least one image of a second image type, wherein the second image type is selected from the group consisting of: a time-of-flight image, one or more multispectral images, and a fluorescence image (column 3, lines 12-20, wherein there is provided a method of transcranial brain optical imaging including obtaining a Laser Speckle (LS) image, of cranial blood vessels of a subject, obtaining a Dynamic Fluorescence (DF) image, as the second type image, of the cranial blood vessels of the subject, and combining the LS image and the DF image producing a combined color image which displays both structure of the cranial blood vessels and perfusion of blood along the cranial blood vessels). Dvorsky and Harmelin are combinable because they both disclose tissue perfusion determination. Therefore, before the effective filing data of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the images of a laser speckle image and a fluorescence image, of Harmelin’s method/system with Dvorsky’s so that combining the LS image and the DF image producing a combined color image which displays both structure and perfusion of blood along the blood vessels (column 3, lines 17-20).
Claims 25 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Dvorsky in view of US 20220398725 A1 to Wang et al (hereinafter ‘Wang’).
Regarding claims 25 and 53, Dvorsky does not specifically disclose the method further comprising using one or more time-of-flight measurements to standardize perfusion quantification independent of camera positioning. Wang discloses one or more time-of-flight measurements to standardize perfusion quantification (para [0055], wherein although time-of-arrival were shown in the examples shown in FIGS. 5B and 6B, the multiple parameters in the 2D color map may include time of arrival, time of flight, microbubble concentration, flow rate, and/or perfusion rate). Dvorsky and Wang are combinable because they both disclose tissue perfusion determination. Therefore, before the effective filing data of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the time-of-flight measurements to standardize perfusion quantification, of Wang’s method/system with Dvorsky’s so that to discern which areas of the organ received and/or accumulated the contrast agent first (Para [0023]).
Claims 12 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Dvorsky in view of Wang and further in view of Harmelin.
Regarding claims 12 and 40, Dvorsky discloses wherein the at least one image comprises at least one member selected from the group consisting of: one or more multispectral and a fluorescence image (column 5, lines 6-13 and 31-33, wherein a filter 6 may be an NIR long-wave pass filter (cut filter), which is only transparent to wavelengths greater than about 815 nm, or preferably a bandpass filter transmitting at peak wavelengths of between about 830 and about 845 nm, as mutlispectral image, and wherein a fluorescence image captured (column 5, lines 6-13 and 31-33, wherein FIG. 2 shows a typical ICG fluorescent image of a heart showing blood vessels and myocardial tissue). Dvorsky does not specifically disclose an image selected from a time-of-flight image and laser speckle image. Wang discloses a time of flight image (para [0037], wherein images of the sequence may be analyzed to determine a time-to-peak, time-of-arrival, wash-out rate, and/or other desired parameter of a contrast agent (e.g., concentration, flow rate, perfusion rate)). Dvorsky and Wang do not disclose laser speckle image. Harmelin discloses a laser speckle image (column 8, lines 65-67, wherein a transcranial brain optical imaging performed using Laser Speckle Imaging (LSI)). Dvorsky, Wang and Harmelin are combinable because the all disclose tissue image perfusion determination. Therefore, before the effective filing data of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the time-of-flight image, of Wang’s method/system with Dvorsky’s and Harmelin’s so that to discern which areas of the organ received and/or accumulated the contrast agent first (Para [0023]).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHERVIN K NAKHJAVAN whose telephone number is (571)272-5731. The examiner can normally be reached Monday-Friday 9:00-05:00 PST.
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/SHERVIN K NAKHJAVAN/Primary Examiner, Art Unit 2672