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
This application is the U.S. national stage of PCT/IL2023/050425 filed on 04/25/2023, which claims priority of Provisional application PRO 63/334,932 filed on 04/26/2022.
Information Disclosure Statement
The information disclosure statement (“IDS”) filed on 12/17/2025 was reviewed and the listed references were noted.
Drawings
The 14-page drawings have been considered and placed on record in the file.
Objections
Claim 9 is objected to because of the following informalities: Claim 9 recites “from a combination of the blood vessels red color, green color and red color” in which it is assumed that a typographical error has occurred to repeat the “red color” twice as opposed to reciting “red color, green color and blue color”. 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.
Claims 1-5, 7, 9, 11, 14, 16, 19, 22-26, 28, 34, 36, and 38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more, and the claimed invention is directed to non-statutory subject matter as follows. The claims recite identifying blood vessels in an image obtained from a surface of the tissue and determining a feature of the blood vessels as well as a color index which differs with depth.
Step 1:
With regard to Step 1, the instant claims are directed to a method, which is among the statutory categories of invention.
Step 2A – Prong 1:
With regard to Step 2A – Prong 1, for example in Claim 1, the limitations of "the method comprising: (i) identifying blood vessels in an image obtained from a surface of said tissue, (ii) determining for the identified blood vessels one or more of at least one feature of said identified blood vessels, and a color index (32), said color index differs in different depths within said tissue", as drafted only involves mental processes or mathematical calculations, such as the identification of blood vessels in a provided image and determining a feature and color index based on depth of those blood vessels. That is, nothing in the above-described claim elements preclude the steps from practically being performed in the mind or on a piece of paper. If a claim limitation, under its broadest reasonably interpretation covers performance of the limitation in the mind or through mathematical calculations, but for the recitation of a generic apparatus components, such as a processor, computer program, or machine-readable media, then it falls within the "mental processes", which include concepts performed in the human mind, including an observation, evaluation, judgement, opinion, or mathematical calculations groupings of the abstract idea. Accordingly, the claim recites an abstract idea.
Step 2A – Prong 2:
The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception. In the instant case, the additional elements in the claims do not apply, rely on, or use the judicial exception.
This judicial exception is not integrated into a practical application because the claim does not recite any additional steps. Therefore, no additional elements are present to integrate the abstract idea into a practical application. Additional elements which integrate the abstract idea into a practical application requires the limitation to not simply be a field-of-use limitation that does not impose any meaningful limits on practicing the abstract idea. Therefore, the claim as a whole, recites an abstract idea.
Step 2B:
Because the claim fails under Step 2A, the claims are further evaluated under Step 2B. The claim herein does not include additional steps that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration of the abstract idea into practical application, the additional elements/steps amount to no more than insignificant extra-solution activities. Mere instructions to apply an exception using generic apparatus component, such as a processor, cannot provide an inventive concept. The claim is not patent eligible.
Further, with regard to dependent Claims 2-5, 7, 9, 11, 14, 16, 19, 22-26, 28, 34, 36, and 38 viewed individually, these additional steps are under their broadest reasonable interpretation, cover performance of the limitation in the mind and do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims’ limitations amount to significantly more than the abstract idea itself. For example, obtaining a statistical ensemble for the feature in a population of blood vessels as recited in Claim 5 or the feature comprising blood vessel diameter, width, length, tortuosity, oxygen saturation, or flow pattern as recited in Claim 7 are only examples of routine and conventional image processing steps and do not amount to significantly more to consider as inventive steps. Accordingly, Claims 1-5, 7, 9, 11, 14, 16, 19, 22-26, 28, 34, 36, and 38 are rejected under 35 U.S.C. 101.
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.
Claims 1-2, 4-5, 7, 9, 14, 16, 19, 22-26, 34, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (WO 2017216585 A1) in view of Kamon (US 20190008362 A1).
Regarding Claim 1, Jones teaches "A method for characterizing at least one feature of blood vessels at different depths within a tissue of a mammalian subject"; (Jones, Abstract and Pg. 24 Final Paragraph, teaches estimating the value of a physical parameter of biological tissue at a given location based on an intensity value at that location for each extracted image wherein the soft tissue comprises three blood vessels with different uniform diameters with data generation being repeated three times with different depths of submersion for the vessels, i.e., characterize a feature of the blood vessels being the estimated physical parameter of tissue including the blood vessels at different depths within the tissue of a mammalian subject);
"the method comprising: (i) identifying blood vessels in an image obtained from a surface of said tissue"; (Jones, Page 1 Paragraph 4, Page 34 Paragraph 3, Page 42 Final Paragraph, and Page 43 First Paragraph, teaches the identification of given anatomical structures by a segmentation procedure in which the given location corresponds to a region formed by multiple pixels of the acquire image and wherein identified structures within the tissue include blood vessels in which imaging is of tissue surfaces, i.e., identifying blood vessels in an image obtained from a surface of said tissue);
"(ii) determining for the identified blood vessels one or more of at least one feature of said identified blood vessels"; (Jones, Abstract and Pg. 24 Final Paragraph, teaches estimating the value of a physical parameter of biological tissue at a given location based on an intensity value at that location for each extracted image wherein the soft tissue comprises three blood vessels with different uniform diameters with data generation being repeated three times with different depths of submersion for the vessels, i.e., determine at least one feature of the identified blood vessels being the value of a physical parameter).
However, Jones does not explicitly teach "and a color index (R), said color index differs in different depths within said tissue".
In an analogous field of endeavor, Kamon teaches "and a color index (R), said color index differs in different depths within said tissue"; (Kamon, Abstract and Paras. 68 and 83, teaches calculating color information such as an R/G ratio, B/G ratio, and the like of the blood vessel from the RGB image signals in the blood vessel portion wherein a correlation between the blood vessel depth and the brightness ratio of the image signal can be stored in which the correlation is a proportional relationship wherein the brightness ratio increases the blood vessel depth also increases, i.e., color index determined for blood vessels being the color information brightness ratio which differs in different depths).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Jones by including the color index identified for vessels at different depths taught by Kamon. One of ordinary skill in the art would be motivated to combine the references since it estimated blood volume and saturation based on the color (Kamon, Para. 83, teaches the motivation of combination to be to estimate the blood volume and oxygen saturation based on the correlation and brightness of each color after the correction).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date.
Regarding Claim 2, the combination of references of Jones in view of Kamon teaches "The method of claim 1, wherein said color index is different at the tissue surface and at a different depth within said tissue"; (Kamon, Para. 83, teaches the brightness ratio increases as the blood vessel depth increases, i.e., color index being the brightness ratio including R/G or B/G is different at the tissue surface and at a different depth due to depth increasing with the ratio).
The proposed combination as well as the motivation for combining the Jones and Kamon references presented in the rejection of Claim 1, applies to claim 2. Thus, the method recited in claim 2 is met by Jones in view of Kamon.
Regarding Claim 4, the combination of references of Jones in view of Kamon teaches "The method of claim 1, wherein said identifying blood vessels comprises segmenting said blood vessels in said image"; (Jones, Page 1 Paragraph 4, Page 34 Paragraph 3, Page 42 Final Paragraph, and Page 43 First Paragraph, teaches the identification of given anatomical structures by a segmentation procedure in which the given location corresponds to a region formed by multiple pixels of the acquire image and wherein identified structures within the tissue include blood vessels in which imaging is of tissue surfaces, i.e., identifying blood vessels in an image by segmenting the vessels).
Regarding Claim 5, the combination of references of Jones in view of Kamon teaches "The method of claim 1, wherein said determining at least one feature comprises (i) calculating a probability distribution function (PDF) for said at least one feature, and/or (ii) obtaining a statistical ensemble for said at least one feature in a population of blood vessels"; (Jones, Page 43 Paragraphs 4-5, teaches using a variety of statistical and algorithmic approaches to derive the physical parameter from the extracted images such as using a Bayesian approach using the physical parameter at the estimated location, spectral distribution of light from the tissue, and spectral sensitivity, i.e., obtain a statistical ensemble for a feature in the population of blood vessels).
Regarding Claim 7, the combination of references of Jones in view of Kamon teaches "The method of claim 1, wherein said at least one feature comprises at least one of blood vessel diameter, blood vessel width (w), blood vessel length, blood vessel degree of tortuosity, oxygen saturation level, flow pattern or any combination thereof"; (Kamon, Para. 83, teaches oxygen saturation can be estimated based on the correlation and the brightness value of each color after correction, i.e., one feature of the blood vessel comprises oxygen saturation).
The proposed combination as well as the motivation for combining the Jones and Kamon references presented in the rejection of Claim 1, applies to claim 7. Thus, the method recited in claim 7 is met by Jones in view of Kamon.
Regarding Claim 9, the combination of references of Jones in view of Kamon teaches "The method of claim 1, wherein said color index is calculated (i) from the blood vessels color band and/or (ii) from a combination of the blood vessels red color, green color and red color"; (Kamon, Para. 68, teaches it is possible to calculate color information such as the R/G ratio, B/G ration, and the like of the blood vessel from the RGB image signals in the blood vessel portion, i.e., color index calculated from a combination of the blood vessels red, green, and blue color).
The proposed combination as well as the motivation for combining the Jones and Kamon references presented in the rejection of Claim 1, applies to claim 9. Thus, the method recited in claim 9 is met by Jones in view of Kamon.
Regarding Claim 14, the combination of references of Jones in view of Kamon teaches "The method of claim 1, comprising obtaining an image of said tissue, optionally wherein said image is obtained by visible light imaging and/or infra-red-light imaging"; (Jones, Page 8 Paras. 4-5, teaches the image capture device is typically an RGB device which captures an image in overlapping visible wavebands and wherein the image capture device may capture images concurrently in just two optical wavebands or in four or more optical wavebands which may fall within the visible part of the spectrum or extend into the infrared, i.e., obtaining an image of tissue obtained by visible light and/or infra-red light imaging).
Regarding Claim 16, the combination of references of Jones in view of Kamon teaches "The method of claim 1, for determining (i) spatial coordinates of the blood vessels within the tissue, (ii) spatial correlation of the at least one feature of the blood vessels and/or of the spatial coordinates of the blood vessels, and/or (iii) directional correlation of at least one feature of the blood vessels and/or of the spatial coordinates of the blood vessels"; (Kamon, Para. 76 and FIG. 9, teaches the signal of the blood vessel portion is observed spatially spread wherein the blood vessel portion is shows to have positions of points P1 to P4, i.e., determine spatial coordinates of the blood vessels within tissue).
The proposed combination as well as the motivation for combining the Jones and Kamon references presented in the rejection of Claim 1, applies to claim 16. Thus, the method recited in claim 16 is met by Jones in view of Kamon.
Regarding Claim 19, the combination of references of Jones in view of Kamon teaches "The method of claim 1, for characterizing a physiological process in said tissue, optionally wherein said physiological process is (i) differentiation, angiogenesis or apoptosis and/or (ii) associated with changes in blood vessels over time"; (Jones, Page 2 Paragraph 3, teaches imaging geometry by looking at the change in measurement over time in response to stimuli such as imaging the change in oxygenation, i.e., physiological process in tissue being oxygenation associated with change in the blood vessels over time).
Regarding Claim 22, the combination of references of Jones in view of Kamon teaches "The method of claim 1, comprising determining said at least one feature in at least two temporarily separated time points to monitor changes in blood vessels in said different depths within said tissue over time"; (Jones, Page 2 Paragraph 3 and Pg. 24 Final Paragraph, teaches imaging geometry by looking at the change in measurement over time in response to stimuli such as imaging the change in oxygenation wherein data generation is repeated with different depths of submersion for the vessels, i.e., physiological process in tissue being oxygenation associated with change in the blood vessels over time which would require monitoring the feature of oxygenation in at least two time points).
Regarding Claim 23, the combination of references of Jones in view of Kamon teaches "The method of claim 1, wherein said tissue is associated with changes in blood vessels with time"; (Jones, Page 2 Paragraph 3, teaches imaging geometry by looking at the change in measurement over time in response to stimuli such as imaging the change in oxygenation, i.e., physiological process in tissue being oxygenation associated with change in the blood vessels over time).
Regarding Claim 24, the combination of references of Jones in view of Kamon teaches "The method of claim 23, wherein said changes in blood vessels comprise enhanced growth or destruction of blood vessels in said tissue"; (Jones, Pages 1-2, teaches visualization of tissue oxygenation in real-time wherein the imaging helps identify increased vascularization of malignant tissue by resulting in a local increase of the total hemoglobin within the tissue, i.e., changes in blood vessels comprise enhanced growth).
Regarding Claim 25, the combination of references of Jones in view of Kamon teaches "The method of claim 1, wherein said tissue comprises at least a portion of said blood vessels that can be viewed from outside the tissue"; (Jones, Pg. 24 Final Paragraph and Pg. 25 First paragraph, teaches creating multi-spectral image data of blood vessels with different depths of submersion wherein the detector is 10mm away from the tissue surface, i.e., blood vessels viewed from outside the tissue).
Regarding Claim 26, the combination of references of Jones in view of Kamon teaches "The method of claim 1, wherein said tissue is selected from the group consisting of: liver, kidneys, lungs, brain, heart, intestine, muscles, skin, a retina, uterine and a cancerous tissue, optionally wherein said tissue is uterine"; (Jones, Pages 1-2, teaches the multispectral imaging helping to identify malignant tissue, assess the success of a uterine transplant procedure, and assessment of bowel perfusion, i.e., tissue consists of intestine, uterine, and cancerous tissue).
Regarding Claim 34, the combination of references of Jones in view of Kamon teaches "The method of claim 1, being (i) an ex-vivo method and/or (ii) an in vivo method"; (Jones, Figures 6 and 8, show the RGB image of the in vivo biological tissue, i.e., method is in vivo).
Regarding Claim 38, the combination of references of Jones in view of Kamon teaches "The method of claim 1, for determining a pathological condition of a subject, optionally wherein said subject (i) is diagnosed with a condition associated with enhanced growth of blood vessels in said tissue and/or (ii) is suffering from a proliferative disorder"; (Jones, Pages 1-2, teaches visualization of tissue oxygenation in real-time wherein the imaging helps identify increased vascularization of malignant tissue by resulting in a local increase of the total hemoglobin within the tissue, i.e., diagnosed with a condition associated with enhanced growth of blood vessels being cancerous or malignant tissue).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Jones in view of Kamon and Ebisawa (US 20180168457 A1).
Regarding Claim 3, the combination of references of Jones in view of Kamon does not explicitly teach "The method of claim 1, wherein said depths within said tissue is at most about 10 cm measured from said tissue surface".
In an analogous field of endeavor, Ebisawa teaches "The method of claim 1, wherein said depths within said tissue is at most about 10 cm measured from said tissue surface"; (Ebisawa, Para. 52, teaches imaging a blood vessel tissue in a deep part in the breast about 2 to 3 cm in depth from the surface, i.e., depth is no more than 10 cm from the surface).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Jones and Kamon by including the depths within the tissue is at most 10 cm taught by Ebisawa. One of ordinary skill in the art would be motivated to combine the references since it mitigates large number of vessels in the tissue (Ebisawa, Para. 52, teaches the motivation of combination to be to mitigate the large number of neovascular vessels of cancer tissue).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Jones in view of Kamon and Berezhna et al. (US 20170178361 A1).
Regarding Claim 11, the combination of references of Jones in view of Kamon does not explicitly teach "The method of claim 9, wherein said color index is calculated from a combination of Ravg, Gavg and Bavg, optionally wherein said color index is (i) calculated as (Bavg+Gavg)/Ravg (Formula I) and/or (ii) calculated as Bavg/Ravg (Formula II)".
In an analogous field of endeavor, Berezhna teaches "The method of claim 9, wherein said color index is calculated from a combination of Ravg, Gavg and Bavg, optionally wherein said color index is (i) calculated as (Bavg+Gavg)/Ravg (Formula I) and/or (ii) calculated as Bavg/Ravg (Formula II)"; (Berezhna, Claims 1 and 21, teaches obtaining a digital color image of the specimen and defining a region of interest based on a biological feature of the specimen and separating the image into individual color channels wherein a color signature for the ROI is determined comprising a color coefficient calculated by determining the ratio of the mean intensity value for a blue color channel to the mean intensity value for a red color channel, i.e., color index calculated as Bavg/Ravg).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Jones and Kamon by including the determination of the color index calculated as Blue average divided by Red average taught by Berezhna. One of ordinary skill in the art would be motivated to combine the references since it assesses the specimens based on the color signature (Berezhna, Abstract, teaches the motivation of combination to be to assess a specimen based on a determined color signature).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date.
Claims 28 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Jones in view of Kamon and Schnorr (US 20200395117 A1).
Regarding Claim 28, the combination of references of Jones in view of Kamon does not explicitly teach "The method of claim 1, for (i) monitoring menstrual cycle in said subject, (ii) diagnosis infertility or infertility-related conditions in said subject, (iii) selecting the timing of embryo transfer and implantation, (iv) evaluating receptivity of the endometrium to embryo implantation in a subject, (v) determining suitability and timing for embryo transfer and implantation in a uterine of a subject, and/or (vi) characterizing said blood vessel population at different times of the menstrual cycle".
In an analogous field of endeavor, Schnorr teaches "The method of claim 1, for (i) monitoring menstrual cycle in said subject, (ii) diagnosis infertility or infertility-related conditions in said subject, (iii) selecting the timing of embryo transfer and implantation, (iv) evaluating receptivity of the endometrium to embryo implantation in a subject, (v) determining suitability and timing for embryo transfer and implantation in a uterine of a subject, and/or (vi) characterizing said blood vessel population at different times of the menstrual cycle"; (Schnorr, Paras. 15 and 28, teaches performing ultrasound imaging to measure follicular size and monitor the response to predict likelihood of an egg in the follicle, quality of the egg, and the likelihood the egg is mature, i.e., monitoring the menstrual cycle in said subject).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Jones and Kamon by including the monitoring of the menstrual cycle of a subject taught by Schnorr. One of ordinary skill in the art would be motivated to combine the references since it assists in the image processing framework for assisted reproductive technology (Schnorr, Para. 2, teaches the motivation of combination to be to provide an adaptive digital image processing framework for use in assisted reproductive technology and ovarian induction).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date.
Regarding Claim 36, the combination of references of Jones in view of Kamon and Schnorr teaches "The method of claim 1, wherein said mammalian subject is (i) considered to undergo or in the process of in vitro fertilization (IVF) and/or (ii) diagnosed with a condition associated with destruction of blood vessels in said tissue"; (Schnorr, Paras. 15, 21, and 28, teaches performing ultrasound imaging to measure follicular size and monitor the response to predict likelihood of an egg in the follicle, quality of the egg, and the likelihood the egg is mature wherein IVF is being managed with the identification, counting, measurement, and differential tracking of the growth follicles and the determination of the optimal timing for OI with the goal to maximize the pregnancy rate while simultaneously minimizing the risk of multiple pregnancies and wherein time-to-event outcomes include embryo quality and implantation, i.e., subject is undergoing in vitro fertilization).
The proposed combination as well as the motivation for combining the Jones, Kamon, and Schnorr references presented in the rejection of Claim 28, applies to claim 36. Thus, the method recited in claim 36 is met by Jones in view of Kamon and Schnorr.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW STEVEN BUDISALICH whose telephone number is (703)756-5568. The examiner can normally be reached Monday - Friday 8:30am-5:00pm EST.
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, Amandeep Saini can be reached on (571) 272-3382. 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.
/ANDREW S BUDISALICH/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662
Prosecution Insights