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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 10, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on June 23, 2021 are accepted.
Claim Rejections - 35 USC § 112(a)
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.
Claim 8 is 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 8 recites “the reflected light independent of interference due to characteristics of the tissue”. Claim 8 depends on claim 1 and all the steps are implemented by a processor. This limitation hence is a computer/processor-implemented functional claim limitation as it is directed to a processor-controlled measurement of tissue perfusion and tissue oxygenation. Yet the specification does not disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed functions in claim 8, i.e., how does a processor to control the measurement to be based on the reflected light that is independent of interferences, in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. Note that this claim is also rejected under 35 U.S.C. 112(b) as considered below. There is no further disclosure in regard to how this step is performed according to either interpretation considered in the 112(b) rejection.
It is not enough to disclose that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015). As the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention, these claims are rejected for lack of written description. For more information regarding the written description requirement, see MPEP §§ 2161, 2162-2163.07(b).
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.
Claim 8 is 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 pre-AIA the applicant regards as the invention.
Claim 8 recites “the reflected light independent of interference due to characteristics of the tissue” that renders the scope of the claim indefinite. It is unclear whether it is the independence that is due to the characteristics of the tissue, or it is the interference that is due to the characteristics of the tissue. In other words, it is unclear whether (1) the reflected light may be independent or dependent of interference, and whether it is independent or dependent is based on the tissue that the light is reflected from, or (2) the reflected light is independent of interference, and the interference refers to an interference between the tissue and the reflected light. Note that this limitation is also rejected under 35 U.S.C. 112(a), written description support as considered above. For examination purpose, the above interpretation (2) is considered such that the reflected light is processed to be independent from the interference.
The dependent claims of the above rejected claims are rejected due to their dependency.
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 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.
(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 1-2, 4-5, 7-8 and 10-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fan et al., US 2020/0138360 A1, hereinafter Fan.
Claim 1. Fan teaches a system, comprising:
a controller comprising a memory that stores instructions and a processor that executes the instructions ([0079]: Module 112 is a controller, classifier, and processor that may be coupled with probe 100 in some alternatives; [0086]: following image acquisition in different orientations, the controller/classifier/processor 112 may process the image data for each subject orientation; and [0388]: If implemented in software, the functions may be stored on or transmitted over as one or more instructions or code on a computer-readable medium. The steps of a method or algorithm disclosed herein may be implemented in a processor-executable software module which may reside on a computer-readable medium. Computer-readable media includes both computer storage medium and communication media…such computer-readable media may include RAM, ROM, EEPROM, CD-ROM or other optical disk storage, or any other medium that may be used to store desired program code in the form of instructions or data structures and that may be accessed by a computer);
a light source that emits emission light towards tissue at six or more predetermined central wavelengths ([0070]: probe 100 comprises one or more light sources, in this case four light sources 101, 104, 118 and 120, and image acquisition device 102. Light sources 101, 104, 118 and 120 illuminate the tissue region, in this case, tissue 103; and [0071]: Multiple narrowband light sources or broadband light sources with selectable filters (e.g., filter wheels) may be used to serially or simultaneously illuminate the tissue 103 with light in multiple spectral bands. The center wavelength of the chosen spectral bands typically reside in the visible and near-infrared wavelengths, such as between 400 nm to 1100 nm e.g., less than (but not zero), at least, or equal to 400, 500, 600, 700, 800, 900, 1000, or 1100 nm or a range defined by any wavelength between any two of the aforementioned wavelengths; and [0095]: In some embodiments, absorbance spectra of approximately or at 515, 750 and/or 972 nm wavelengths can be used, while in other embodiments the absorbance spectra of approximately or at 542, 669 and/or 960 nm wavelengths can be used; [0227] discloses further specific central wavelengths); and
a camera that detects reflected light reflected from the tissue based on the emission light ([0078]: As further illustrated in FIG.1A, image acquisition device 102 is configured to receive reflected light from the tissue 103. The image acquisition device 102 can detect light from the illuminated region, a sub-region of the illuminated region, or a non-illuminated region. As illustrated further below, the field of view of the image acquisition device 102 may include the entire body surface of the subject facing the probe 100. When the entire subject facing the probe is illuminated and the entire subject facing the probe is in the field of view of the image acquisition device, the speed and ease of classification is enhanced. The image acquisition device 102 may be a two-dimensional charge-coupled device (CCD) or complementary metal-oxide semiconductor (CMOS) image acquisition device with appropriate optics for imaging all or part of the illuminated tissue 103; and [0090]: probe 408 can comprise multiple cameras and imagers, prisms, beam-splitters, photodetectors, and filters, as well as light sources of multiple spectral bands. The camera(s) can measure scattering, absorption, reflection, transmission, and/or florescence of different wavelengths of light over time from the tissue region), wherein, when executed by the processor, the instructions cause the system to:
measure tissue perfusion based on the reflected light; and measure tissue oxygenation based on the reflected light ([0151]: FIG.12 illustrates a high-level graphical overview of two optical imaging techniques, photoplethysmography imaging (PPG imaging) and multispectral imaging (MSI) that can be combined with patent health metrics to generate prognostic information…The two optical imaging methods are designed to infer important tissue characteristics, including arterial perfusion and tissue oxygenation; and [0154]: the disclosed imaging technology is designed to fuse the optical imaging techniques of photoplethysmography imaging (PPG imaging) and multispectral imaging (MSI); [0224]: PPG and MSI data can be collected simultaneously or sequentially).
Claim 2. Fan further teaches
a filter that simultaneously filters the reflected light to the six or more predetermined central wavelengths ([0091]: Data subset 404 may include multiple images of the tissue region, each measuring light reflected from the tissue region in a different selected frequency band. The multiple images of data subset 404 may be acquired simultaneously or essentially simultaneously; in [0092] it discloses that the camera is equipped with filters; and [0093]: the filters are monolithically integrated optical interference filters, wherein the plurality of filters is organized in step-wise lines. In some cases, the filters form a wedge and/or a staircase shape. In some instances there may be dozens to hundreds of spectral bands corresponding to wavelengths between 400 to 1100 nm…The imager scans the tissue using each filter line and senses the light reflected from the tissue through each of those filters) – measuring the reflected light using filters for selecting different frequency band to simultaneously acquiring images is considered “simultaneously filters the reflected light” as claimed, i.e., the filtering of the reflection light needs to be simultaneous in order for the image acquisition at the different wavelength band (filtered) to be simultaneous.
Claim 4. Fan further teaches that
the light source emits broadband emission light that includes light at the six or more predetermined central wavelengths ([0071]: Multiple narrowband light sources or broadband light sources with selectable filters (e.g., filter wheels) may be used to serially or simultaneously illuminate the tissue 103 with light in multiple spectral bands. The center wavelength of the chosen spectral bands typically reside in the visible and near-infrared wavelengths, such as between 400 nm to 1100 nm e.g., less than (but not zero), at least, or equal to 400, 500, 600, 700, 800, 900, 1000, or 1100 nm or a range defined by any wavelength between any two of the aforementioned wavelengths).
Claim 5. Fan further teaches that
The filters the reflected light to the six or more predetermined central wavelengths one at a time ([0092]: the one or more cameras are coupled to a filter wheel with a plurality of filters with different passbands; [0118]: the camera can sequentially capture single wavelength images through each of the eight filters as the filter wheel is rotated).
Claim 7. Fan further teaches that
the filter comprises a motorized filter wheel ([0117]: FIG.8: multi-spectral images can be collected by the Staring method using a filter-wheel camera (for example, SpectroCam, Pixelteg; Largo, Fla.) equipped with eight unique optical band-pass filters between 400 and 1100 nm wavelengths; [0079]: Module 112 controls the probe, which may include setting such as…filter color) – a filter wheel is known in the field of art to be rotatable. The rotation may be done manually or automatically as a motor-controlled, i.e., motorized. Since Fan teaches that the operation of the probe is controlled by the module 112, the operation is considered automatic, hence the rotation of the filter wheel is motorized.
Claim 8. Fan teaches all the limitations of claim 1, including “the tissue perfusion and the tissue oxygenation are measured based on the reflected light” ([0151], [0154], [0224]).
Fan further teaches that the reflected light is independent of interferences due to characteristics of the tissue ([0093]: the filters are monolithically integrated optical interference filters) – having the reflected light filtered with an optical interference filters is considered the reflected light, upon being filtered, becomes “independent of interferences due to characteristics of the tissue” as claimed.
Claim 10. Fan further teaches that
the light source comprises a multi-wavelength light source ([0070]: the one or more light sources may emit white light or light that falls in one or more spectral bands; and [0071]: visible and near-infrared wavelengths such as between 400 to 1100 nm) .
Claim 11. Fan further teaches that
the light source comprises a light-emitting diode (LED) light source ([0070]: the one or more light sources may be light-emitting diodes (LEDs)).
Claim 12. Fan teaches all the limitations of claim 1, including the light source having the predetermined central wavelengths ([0070], [0071], [0095] and [0227])
Fan further teaches that
the light source comprises lasers ([0010]: several instruments that are known to accurately determine the perfusion and oxygenation of the skin tissue have been tested in this testing, including TCOM, SPP, and laser Doppler).
Laser Doppler is known in the field of art that uses a laser light source to assess vascular condition based on the Doppler effect.
Claim 13. Fan further teaches that
the camera is configured to perform imaging photoplethysmography (PPG) ([0151]: FIG.12 illustrates a high-level graphical overview of two optical imaging techniques, photoplethysmography imaging (PPG imaging) and multispectral imaging (MSI)).
Claim 14. Fan further teaches that
the camera comprises a multispectral camera configured to detect the six or more central wavelengths as a fixed configuration ([0092] the one or more cameras are coupled to a filter wheel with a plurality of filters with different passbands; and [0093]: …(instead of) the discrete bands of each filter in a filter wheel; and [0117]: FIG.8: in some alternatives multi-spectral images can be collected by the Staring method using a filter-wheel camera equipped with eight unique optical band-pass filters between 400 and 1100 nm wavelength) – having discrete bands for each filter with eight unique optical band-pass filters is considered the six or more central wavelength “as a fixed configuration” as claimed.
Claim 15. Fan further teaches
a filter, wherein the camera comprises a multispectral camera and the filter is configured to filter the reflected light to the six or more central wavelengths as a fixed configuration ([0092] the one or more cameras are coupled to a filter wheel with a plurality of filters with different passbands; and [0093]: …(instead of) the discrete bands of each filter in a filter wheel; and [0117]: FIG.8: in some alternatives multi-spectral images can be collected by the Staring method using a filter-wheel camera equipped with eight unique optical band-pass filters between 400 and 1100 nm wavelength) – having discrete bands for each filter with eight unique optical band-pass filters is considered the six or more central wavelength “as a fixed configuration” as claimed.
Claim 16. Fan further teaches that
the camera comprises a hyperspectral camera configured to detect the six or more central wavelengths as a tunable configuration ([0093]: the one or more cameras comprise a hyperspectral line-scan imager. A hyper-spectral line-scanner has continuous spectral bands…the filters are monolithically integrated optical interference filters…there may be dozens to hundreds of spectral bands corresponding to wavelengths between 400 to 1100 nm…or a range defined by any wavelength that is between any two of the aforementioned wavelengths) – setting the wavelength to be a range defined by any wavelength between 400 and 1100 nm is considered the six or more central wavelengths as “a tunable configuration” as claimed.
Claim 17. Fan further teaches
a filter, wherein the camera comprises a hyperspectral camera and the filter is configured to filter the reflected light to the six or more central wavelengths as a tunable configuration ([0093]: the one or more cameras comprise a hyperspectral line-scan imager. A hyper-spectral line-scanner has continuous spectral bands…the filters are monolithically integrated optical interference filters…there may be dozens to hundreds of spectral bands corresponding to wavelengths between 400 to 1100 nm…or a range defined by any wavelength that is between any two of the aforementioned wavelengths) – setting the wavelength to be a range defined by any wavelength between 400 and 1100 nm is considered the six or more central wavelengths as “a tunable configuration” as claimed.
.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Fan et al., US 2020/0138360 A1, hereinafter Fan.
Claim 3. Fan teaches all the limitations of claim 2, including “the filter simultaneously filters the reflected light” ([0091], [0092] and [0094]).
Fan further teaches that the reflected light is filtered to six predetermined central wavelengths ([0095] and [0098]-[0100] illustrates at least six predetermined central wavelengths).
In regard to the number of the predetermined central wavelength to be six, It is considered among various common practices that normally requires only ordinary skill in the art and hence are considered routine expedients. Such an alternate configuration is considered merely duplication of parts, which the court has held normally require only ordinary skill in the art and hence is considered routine expedients.
Fan teaches that the wavelengths of the light emission may be selected based on various purposes, for example, [0099] teaches “other wavelengths for effectively classifying necrotic tissue and/or any other tissue condition described in this disclosure may be found”, and [0100] teaches “this [wavelength] set was effective at imaging amputation sites and separating imaged amputation site tissue into categories”. Therefore, it would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to arrive such a configuration through routine experimentation with reasonable expectation of success. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.).. MPEP 2144.04.VI.B.
Claim 6. The system of claim 5, wherein the filter filters the reflected light to six predetermined central wavelengths ([0095] and [0098]-[0100] illustrates at least six predetermined central wavelengths).
In regard to the number of the predetermined central wavelength to be six, It is considered among various common practices that normally requires only ordinary skill in the art and hence are considered routine expedients. Such an alternate configuration is considered merely duplication of parts, which the court has held normally require only ordinary skill in the art and hence is considered routine expedients.
Fan teaches that the wavelengths of the light emission may be selected based on various purposes, for example, [0099] teaches “other wavelengths for effectively classifying necrotic tissue and/or any other tissue condition described in this disclosure may be found”, and [0100] teaches “this [wavelength] set was effective at imaging amputation sites and separating imaged amputation site tissue into categories”. Therefore, it would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to arrive such a configuration through routine experimentation with reasonable expectation of success. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.).. MPEP 2144.04.VI.B.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Fan et al., US 2020/0138360 A1, hereinafter Fan, in view of Cross et la., US 2019/0216326 A1, hereinafter Cross.
Claim 9. Fan further teaches that
the six or more predetermined central wavelengths are optimized for simultaneous detection of tissue perfusion, tissue oxygenation ([0151]: FIG.12 illustrates a high-level graphical overview of two optical imaging techniques, photoplethysmography imaging (PPG imaging) and multispectral imaging (MSI) that can be combined with patent health metrics to generate prognostic information…The two optical imaging methods are designed to infer important tissue characteristics, including arterial perfusion and tissue oxygenation; [0224]: PPG and MSI data can be collected simultaneously or sequentially), total hemoglobin ([0160]: MSI data can be used to quantify the volume fraction of hemoglobin) and methemoglobin, independent of interferences due to characteristics of the tissue ([0093]: the filters are monolithically integrated optical interference filters) – having the reflected light filtered with an optical interference filters is considered the reflected light, upon being filtered, becomes “independent of interferences due to characteristics of the tissue” as claimed, and wherein, when executed by the processor, the instructions further cause the system to:
apply a trained convolutional neural network to the reflected light to obtain an output comprising an estimate of the tissue perfusion, an estimate of tissue oxygenation, an estimate of total hemoglobin and an estimate of methemoglobin ([0162]: the machine learning model can be trained to generate a quantitative output after assessing all data collected by the amputation site analysis system. The quantitative output can be translated into an image identifying areas of the scanned tissue surface…, to generate a mapping of various regions of tissue classifications, and/or to recommend a LOA; and [0171]: a range of classifier models can be implemented for sorting the data, including but not limited to linear and 1quadratic discriminant analyses, decision trees, clustering, and neural networks, and convolutional neural networks).
Fan does not teach that the methemoglobin is detected and estimated. However, in an analogous optical imaging based tissue assessment field of endeavor, Cross teaches that the methemoglobin is detected and estimated ([0066]: discriminating tissue from a diabetic limb ulcer from healthy viable tissue may be done by evaluating the tissue region for certain physiological markers such as, would oxygenation, perfusion (i.e., total hemoglobin), methemoglobin and water content. To the best of their knowledge, the inventors are the first to use met Hb as a physiological marker and also to be able to create digital images of metHb using portable optical imaging).
When Fan and Cross are combined, metHemoglobin is an additional marker together with hemoglobin when assessing tissue perfusion and oxygenation, and is estimated with the trained convolutional neurol network taught in Fan.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system of Fan employ such a feature of having methemoglobin is detected and estimated as taught in Cross for the advantage of “being used as a physiological marker to discriminate diseased tissue from healthy viable tissue”, as suggested in Cross, [0066].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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, Pascal M Bui-Pho can be reached at 571-272-2714. 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.
/YI-SHAN YANG/Primary Examiner, Art Unit 3798