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 .
Election/Restrictions
Applicant’s election of Invention I (claims 1-10, 14-15, and 18-20) in the reply filed on August 13, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 11-13 and 16-17, directed to the other Inventions, have been cancelled. New claims 21-25 have been added. Claims 1-10, 14, 15, and 18-25 are pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “imaging system for…” and “image control and processing system configured for” in claim 20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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, 2, 4, 6, 7, 9, 15, 18-20, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shahidi et al. (U.S. Publ. No. 2013/0070201).
Regarding claim 1, Shahidi discloses an apparatus and method for assessing the microvascular circulation of using images of an eye. More specifically and as it relates to the applicants claims, Shahidi discloses a method of diagnosing a condition of a subject, comprising:
receiving a stream of image data of an anterior of an eye of the subject at a rate of at least 30 frames per second (see paragraphs 0010 and 0015 where images are captures at at least 30HZ; also see paragraphs 0007, 0044, and 0046 where the conjunctiva, i.e. part of the anterior of an eye, is captured);
applying a spatio-temporal analysis (see paragraph 0008, 0011, 0036, and 0081 where spatio-temporal analysis of the images is performed) to said stream to detect flow of individual blood cells in limbal or conjunctival blood vessels of said eye (see paragraph 0081 where blood cells are tracked when performing the spatio-temporal analysis);
based on detected flow, determining the condition of the subject (see paragraphs 0036-0050 where the blood flow measurements are used to diagnose and monitor vascular and blood disorders).
As for claim 2, Shahidi discloses identifying hemodynamic changes in the body of the subject based on said detected flow. See paragraphs 0013, 0044, and 0050 where hemodynamic changes are identified.
With regard to claim 4, Shahidi discloses that the image data comprise at least one monochromatic image. See paragraph 0082 where a grayscale image is used.
Regarding claim 6, Shahidi discloses that applying said spatio-temporal analysis is selected to detect in said eye morphology of limbal or conjunctival blood vessels, wherein said determining the condition is based also on said detected morphology. See paragraphs 0077-0083 where morphological processes to acertain vasculature are performed and used to determine the condition. In other words the morphology of the eye is used to determine the conditions of the blood flow, which is in turn used to determine the condition.
As for claim 7, Shahidi discloses identifying flow of gaps. See paragraph 0082 where the space between RBC columns (i.e. gaps) are used to determine flow.
With regard to claim 9, Shahidi discloses detecting said flow is in at least two different vessels structures. See Figure 8 and 9 and paragraphs 0085 where the flow in multiple different vessel structures are obtained. Also see paragraph 0050 where blood flow in multiple vessels is obtained.
As for claim 15, Shahidi discloses capturing said image data. See paragraph 0061 where images are captured.
Regarding claim 18, Shahidi discloses the condition is selected from the group consisting of a disease (see paragraph 0037), a bacterial disease, a viral disease, a coronavirus disease, sepsis, heart failure, an ischemic condition (see paragraph 0037), cardiovascular disease, hematological disease, glaucoma, leukemia, a neuronal attenuation, anemia (see paragraph 0042), neutropenia, polycythemia, jaundice, conjunctivitis, and any other condition or disease that affects blood content count and blood vessel flow (see paragraphs 0035-0050).
As for claim 19, Shahidi discloses generating an output describing the condition in terms of at least one parameter selected from the group consisting of white blood cells count, red blood cells count, platelets count, hemoglobin level, oxygenated hemoglobin level, deoxygenated hemoglobin level, methemoglobin level, capillary perfusion, ocular inflammation, blood vessel inflammation, and blood flow (see Figures 8A, 8B, 9, 10, and 11 and paragraphs 0085-0087 where the blood flow is output).
With regard to claim 20, Shahidi discloses a system (apparatus, 200; see Figure 2 and paragraph 0052) for diagnosing a condition of a subject, comprising: an imaging system (light source, 220, and detector, 230; see Figure 2 and paragraphs 0053-0061) for capturing image data of an anterior of an eye of the subject (see paragraphs 0007, 0044, and 0046 where the conjunctiva, i.e. part of the anterior of an eye, is captured); and an image control and processing system (processor, 240; See Figure 2 and paragraph 0062-0064) configured for applying the method according to claim 1. See the discussion of claim 1 above.
As for claim 22, Shahidi discloses measuring a flow speed of said gaps. See paragraph 0082 where the space between RBC columns (i.e. gaps) are used to determine flow.
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.
Claim(s) 3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Shahidi et al. (U.S. Publ. No. 2013/0070201) in view of Hamrah et al. (U.S. Publ. No. 20230263389).
Regarding claim 3, as mentioned above in the discussion of claim 1, Shahidi discloses all of the limitations of the parent claim. Shahidi, however, fails to explicitly disclose that the spatio-temporal analysis comprises applying a machine learning procedure. Hamrah, on the other hand, discloses that it is well known in the art to apply a machine learning procedure when analyzing the spatio-temporal characteristics of the blood flow in microvasculature of an eye. More specifically, Hamrah discloses the use of a machine learning process to produce blow flow characteristics. See paragraph 0095 and 0103. One of ordinary skill in the art would recognize the benefits of using a machine learning technique to estimate blood flow in captured images of an eye – including the ability to learn optimal processing rather than require manual algorithm design, higher accuracy, and automatic feature learning. Additionally, Hamrah discloses that the machine learning techniques allow a network to efficiently learn features that are invariant to an exact location in a data set by applying the same learned transformation to subsections of the entire data set. See paragraph 0096. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Shahidi to perform the spatio-temporal analysis using a machine learning procedure.
As for claim 10, as mentioned above in the discussion of claim 1, Shahidi discloses all of the limitations of the parent claim. Shahidi, however, fails to explicitly disclose determining a density of said limbal or conjunctival blood vessels. Hamrah, on the other hand discloses that it is well known in the art to determine a density of conjunctival blood vessels from captured images. See paragraphs 0005, 0017, 0072, 0086, 0088, 0112-0115. Hamrah discloses that the density of conjunctival blood vessels in an anterior portion of an eye provides a good indication of the inflammation of the eye. See paragraph 0005. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Shahidi to determine a density of said limbal or conjunctival blood vessels, that offers a good indication of the inflammation of the eye.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Shahidi et al. (U.S. Publ. No. 2013/0070201) in view of Rotenstreich (U.S. Publ. No. 2016/0262611).
Regarding claim 5, as mentioned above in the discussion of claim 1, Shahidi discloses all of the limitations of the parent claim. Shahidi, however, fails to explicitly disclose applying said spatio-temporal analysis is selected to identify pupil light reflex events, wherein said determining the condition is based also on said identified pupil light reflex events. Rotenstreich, on the other hand, discloses that it is well known in the art to apply a spatio-temporal analysis identify pupil light reflex events, and to determine condition of a subject based on the pupil light reflex events. In particular, Rotenstriech discloses system (120) that uses cameras (106) to capture images of a pupil response to stimulus. See Figure 3 and paragraph 0166-0169 where the number of images and stimulus are selected. As noted in paragraph 0171 images are continually captured. As noted in paragraph 0179 the output of the test may be used to evaluate the individual for various eye issues. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Shahidi to apply said spatio-temporal analysis is selected to identify pupil light reflex events, and determine the condition also based on said identified pupil light reflex events, so that it may be used to asses the state of health of the eyes. See paragraph 0055.
Claim(s) 8, 21, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Shahidi et al. (U.S. Publ. No. 2013/0070201) in view of Castro-Gonzalez et al. (U.S. Patent No. 11,963,750).
Regarding claim 8, as mentioned above in the discussion of claim 7, Shahidi discloses all of the limitations of the parent claim. Shahidi, however, fails to explicitly disclose measuring a size of said gaps. Castro-Gonzalez, on the other hand, discloses that it is well known in the art to measuring the size of a gap in blood flow. See column 35, line 64 to column 36, line 13 where an observed size of a capillary event is used to select the best data for estimating blood flow. Also see column 10, lines 24-30 and column 28, line 55 to column 29, line 16 where the capillary event is defined as a gap between red blood cells. Castro-Gonzalez discloses that this feature allows an improved correlation with white blood cells. See column 36, lines 11-13. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Shahidi to measure a size of said gaps.
As for claim 21, as mentioned above in the discussion of claim 7, Shahidi discloses all of the limitations of the parent claim. Shahidi, however, fails to explicitly disclose identifying gaps between two red blood cells as white blood cells. Castro-Gonzalez, on the other hand, discloses that it is well known in the art to identify gaps between two red blood cells as white blood cells. See paragraph 28, line 45 to column 29, line 16. Also see column 39, lines 16-20. Castro-Gonzalez discloses that the ability to identify white blood cells allows for the ability to non-invasively diagnose rheumatological diseases. See column 9, lines 1-10. Furthermore, Castro-Gonzalez discloses that white blood cell counts can be a relevant physiological parameter for the diagnosis, monitoring, and treatment of various conditions including, but not limited to, bacterial and viral infections (e.g., pneumonia or meningitis), bone marrow functionality associated with chemotherapy toxicity, and hematologic proliferative processes such as leukemia. See column 1, lines 36-53. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Shahidi to identify gaps between two red blood cells as white blood cells.
With regard to claim 23, as mentioned above in the discussion of claim 1, Shahidi discloses all of the limitations of the parent claim. Shahidi, however, fails to explicitly disclose generating an output pertaining to a white blood cell count. Castro-Gonzalez, on the other hand, discloses that it is well known in the art to generate an output pertaining to white blood cell count. See column 8, line 61-64, and column 10, lines 36-40. Castro-Gonzalez discloses that white blood cell counts can be a relevant physiological parameter for the diagnosis, monitoring, and treatment of various conditions including, but not limited to, bacterial and viral infections (e.g., pneumonia or meningitis), bone marrow functionality associated with chemotherapy toxicity, and hematologic proliferative processes such as leukemia. See column 1, lines 36-53. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Shahidi to generate an output pertaining to a white blood cell count.
Regarding claim 24, as mentioned above in the discussion of claim 1, Shahidi discloses all of the limitations of the parent claim. Shahidi, however, fails to explicitly disclose that capturing said image data comprises illuminating said anterior of an eye with light at a wavelength selected to generate contrast at image regions corresponding to eye regions dominated by white blood cells. Castro-Gonzalez, on the other hand, discloses that it is well known in the art to capture image data with an illumination that generates contrast at image regions for capture of white blood cell data. See column 11, line 67 to column 12, line 4; column 28, lines 50-55; and column 39, line 16-20. Castro-Gonzalez discloses that this results in improved images. See column 12, line 4. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Shahidi to illuminate said anterior of an eye with light at a wavelength selected to generate contrast at image regions corresponding to eye regions dominated by white blood cells.
Claim(s) 14 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Shahidi et al. (U.S. Publ. No. 2013/0070201) in view of Ince et al. (U.S. Publ. No. 2020/0310098).
Regarding claim 14, as mentioned above in the discussion of claim 1, Shahidi discloses all of the limitations of the parent claim. Shahidi, however, fails to explicitly disclose that said image data comprises at least one multispectral image at two or more distinct wavelengths. Ince, on the other hand, discloses that it is well known in the evaluation of microcirculation to capture image data at two or more distinct wavelengths. See paragraphs 0070 and 0112. Ince, discloses that this feature allows for the measure of oxygen saturation and can be used to to identify the presence of leucocytes. See paragraph 0112. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Shahidi capture multispectral images at two or more distinct wavelengths.
As for claim 25, as mentioned above in the discussion of claim 1, Shahidi discloses all of the limitations of the parent claim. Shahidi, however, fails to explicitly disclose the ability to identify platelets in said image data. Ince, on the other hand, discloses that it is well known in the art to identify platelets in captured image which are used to characterize microvasculature. See paragraphs 0020, 0071, 0083, and 0085. One of ordinary skill in the art would know the benefit of obtaining a platelet count of a patient, as the platelet count provides an indication of the clotting ability of the patient. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Shahidi to additionally identify platelets in the captured image data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN M VILLECCO whose telephone number is (571)272-7319. The examiner can normally be reached Mon-Thurs 6:00 AM-4:00 PM 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.
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.
/JOHN VILLECCO/Supervisory Patent Examiner, Art Unit 2661
Prosecution Insights