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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/23/2025 has been entered.
Claim Rejections - 35 USC § 112
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.
Claims 1-2 and 4-21 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.
Claims 18 and 20, and all dependents thereof, have been amended to recite the limitations “reference images acquired before displacement of the region of interest” and “deformed images that are acquired after displacement of the region of interest.” However, there is no description of what the reference images and deformed images are, nor when they are acquired, in the original disclosure. While this is one possible interpretation of “reference images” and “deformed images,” there is no indication that this is an inherent definition. Since the timing of the acquisition/definition of “reference images” and “deformed images” is neither described in the original disclosure nor inherent, these limitations are determined to be impermissible new matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4, 7, 12-16, and 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2015/0313573 A1, Nov. 5, 2015) (hereinafter “Liu”) in view of Lim, Shen Yi, et al. "Assessment of stiffness of posterior eye wall in myopic eyes with an ultrasound-based algorithm using strain elastography." Investigative Ophthalmology & Visual Science 63.7 (2022): 3815-3815 (hereinafter “Lim”).
Regarding claim 1: Liu discloses receiving ultrasound data ([0029]; fig. 1, first box); and preprocessing the ultrasound data to enhance signal-to-noise ratio to create pre-processed ultrasound data ([0034]; fig. 1, second box); applying speckle tracking to a region of interest in reference images and defining overlapping kernels ([0034]-[0035]; fig. 1, third through sixth boxes where the sixth box specifies overlapping kernels); comparing the reference images ([0033]; fig. 1, box 1) with deformed images ([0033]-[0035]; fig. 1, third through sixth boxes); and determining, from the comparing, the displacement and deformation within the region of interested from relative motion between the reference images with deformed images that is caused by an ocular pulse (Abstract – “[t]his invention describes an ultrasound technique that maps out the mechanical properties of the cornea and the sclera to the intrinsic mechanical loadings in the eye”, [0006]-[0010] – ocular pulse, [0022] – “spatial mapping of the mechanical strains developed in the cornea or the sclera during ocular pulse”, [0032] – “…outputs the distributive strain data of a given cross-section of at least one portion of the eye as a function of time during the ocular pulse”, [0052] – “[d]uring ocular pulse, the strains corresponding to a small fluctuation of the IOP are recorded using the high frequency ultrasound elastography technique”; [0035]-[0036]; fig. 1, seventh through eleventh boxes); wherein the posterior portion of the eye includes structures behind the anterior hyaloid membrane of the eye ([0022] – the sclera, where the instant disclosure states that the sclera is behind the anterior hyaloid membrane at [0003]).
However, Liu does not disclose that the ultrasound data is acquired by a 20 MHz ultrasound transducer.
Lim, in the same field of endeavor, teaches performing strain elastography of the posterior eye using a 20 MHz ultrasound transducer (see whole document).
In the absence of any evidence of criticality or unexpected result, it would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Liu by acquiring the data using a 20 MHz ultrasound transducer as taught by Lim, to achieve predictable results, because the substitution of one known element for another yields predictable results to one of ordinary skill in the art (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)).
Regarding claim 4: Liu in view of Lim discloses the computer-implemented method of claim 1. Liu further discloses wherein the ultrasound data comprises a cross section image and associated radiofrequency data of the posterior portion of the eye ([0024], [0043] – B-mode is a cross-sectional image).
Regarding claim 7: Liu in view of Lim discloses the computer-implemented method of claim 1. Liu further discloses determining a diagnosis based on the measurement of the posterior portion of the eye of the subject ([0005], [0007], [0041]).
Regarding claim 12: Liu in view of Lim discloses the method of claim 1, wherein the measurement of the posterior portion of the eye of the subject comprises a biomechanical measurement (Liu - [0006], [0032], [0039]).
Regarding claim 13: Liu in view of Lim disclose the method of claim 1, wherein the measurement of the posterior portion of the eye of the subject comprises a biomechanical measurement (Liu - [0006], [0030], [0032]-[0033]).
Regarding claim 14: Liu in view of Lim disclose the method of claim 1, wherein the biomechanical measurement comprises a measurement of strain (Liu - [0006], [0030], [0032]-[0033]).
Regarding claim 15: Liu in view of Lim discloses the method of claim 1, wherein at least one of the ultrasound data comprises radiofrequency data (Liu - [0032], [0034], fig. 1).
Regarding claim 16: Liu in view of Lim disclose the method of claim 15, wherein determining, using OPE, the measurement of the posterior portion of the eye of the subject comprises analyzing radiofrequency data (Liu - [0032], [0034], fig. 1).
Regarding claim 18: Liu discloses an ultrasound probe ([0024], [0009]-[0011]); and a controller comprising at least one processor and at least one memory, the at least one memory having computer-executable instructions stored thereon that, when executed by the at least one processor ([0028], [0043]), cause the at least one processor to: receive ultrasound data from the ultrasound probe ([0029]; fig. 1, first box), the ultrasound data being of a posterior portion of an eye that includes structures behind the anterior hyaloid membrane of the eye ([0022] – the sclera, where the instant disclosure states that the sclera is behind the anterior hyaloid membrane at [0003]); preprocess the ultrasound data to enhance signal-to-noise ratio to create pre-processed ultrasound data ([0034]; fig. 1, second box); apply speckle tracking to a region of interest in reference images and defining overlapping kernels ([0034]-[0035]; fig. 1, third through sixth boxes where the sixth box specifies overlapping kernels); compare the reference images acquired before displacement of the region of interest ([0033]; fig. 1, box 1) with deformed images that are acquired after displacement of the region of interest ([0033]-[0035]; fig. 1, third through sixth boxes); determine, from the comparing, a displacement and deformation within the region of interest based on relative motion induced by an intrinsic ocular pulse of the eye (Abstract – “[t]his invention describes an ultrasound technique that maps out the mechanical properties of the cornea and the sclera to the intrinsic mechanical loadings in the eye”, [0006]-[0010] – ocular pulse, [0022] – “spatial mapping of the mechanical strains developed in the cornea or the sclera during ocular pulse”, [0032] – “…outputs the distributive strain data of a given cross-section of at least one portion of the eye as a function of time during the ocular pulse”, [0052] – “[d]uring ocular pulse, the strains corresponding to a small fluctuation of the IOP are recorded using the high frequency ultrasound elastography technique”; [0035]-[0036]; fig. 1, seventh through eleventh boxes); and use the displacement and deformation to measure the posterior portion of the eye ([0022] – the sclera, where the instant disclosure states that the sclera is a posterior part of the eye which is behind the anterior hyaloid membrane at [0003]).
However, Liu does not disclose that the ultrasound data is acquired by a 20 MHz ultrasound transducer.
Lim, in the same field of endeavor, teaches performing strain elastography of the posterior eye using a 20 MHz ultrasound transducer (see whole document).
In the absence of any evidence of criticality or unexpected result, it would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Liu by acquiring the data using a 20 MHz ultrasound transducer as taught by Lim, to achieve predictable results, because the substitution of one known element for another yields predictable results to one of ordinary skill in the art (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)).
Regarding claim 19: Liu in view of Lim discloses the system of claim 18. Liu further discloses wherein the at least one memory has further computer-executable instructions stored thereon that, when executed by the at least one processor, cause the at least one processor to control the ultrasound probe to generate a high-frequency ultrasound signal ([0028], [0043]).
Regarding claim 20: Liu discloses recording, using an ultrasound probe, ultrasound data from to a posterior portion of an eye of a subject ([0029]; fig. 1, first box) the ultrasound data being of a posterior portion of an eye that includes structures behind the anterior hyaloid membrane of the eye ([0022] – the sclera, where the instant disclosure states that the sclera is behind the anterior hyaloid membrane at [0003]); preprocessing the ultrasound data to enhance signal-to-noise ratio to create pre-processed ultrasound data ([0034]; fig. 1, second box); applying speckle tracking to a region of interest in reference images and defining overlapping kernels ([0034]-[0035]; fig. 1, third through sixth boxes where the sixth box specifies overlapping kernels); comparing the reference acquired before displacement of the region of interest ([0033]; fig. 1, box 1) with deformed images that are acquired after displacement of the region of interest ([0033]-[0035]; fig. 1, third through sixth boxes); determining, from the comparing, the displacement and deformation displacement created by an ocular pulse (Abstract – “[t]his invention describes an ultrasound technique that maps out the mechanical properties of the cornea and the sclera to the intrinsic mechanical loadings in the eye”, [0006]-[0010] – ocular pulse, [0022] – “spatial mapping of the mechanical strains developed in the cornea or the sclera during ocular pulse”, [0032] – “…outputs the distributive strain data of a given cross-section of at least one portion of the eye as a function of time during the ocular pulse”, [0052] – “[d]uring ocular pulse, the strains corresponding to a small fluctuation of the IOP are recorded using the high frequency ultrasound elastography technique”; [0035]-[0036]; fig. 1, seventh through eleventh boxes); and diagnosing an ocular disease based on the measurement of the eye of the subject ([0005], [0007], [0041]).
However, Liu does not disclose that the ultrasound data is acquired by a 20 MHz ultrasound transducer.
Lim, in the same field of endeavor, teaches performing strain elastography of the posterior eye using a 20 MHz ultrasound transducer (see whole document).
In the absence of any evidence of criticality or unexpected result, it would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Liu by acquiring the data using a 20 MHz ultrasound transducer as taught by Lim, to achieve predictable results, because the substitution of one known element for another yields predictable results to one of ordinary skill in the art (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)).
Regarding claim 21: Liu in view of Lim discloses the method of claim 20. Liu further discloses treating the ocular disease (claim 19, [0044], [0010], [0007]).
Claim(s) 2, 5, 6, 10, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu and Lim as applied to claims 1 and 7 above, and further in view of Pavlatos, Elias. Ultrasound Speckle Tracking Methods to Study the Biomechanical Factors of Ocular Disease. The Ohio State University, 2018 (hereinafter “Pavlatos”).
Regarding claim 2: Liu and Lim disclose the computer-implemented method of claim 1, but are silent on the location of a data acquisition window being centered around an optic nerve head.
Pavlatos, in the same field of endeavor, teaches that glaucoma is conventionally diagnosed using a combination of optical nerve head imaging and visual field testing, and that early identification of changes to the optical nerve head structure is critical in diagnosing and monitoring glaucoma (Chapter 1: Glaucoma Biomechanics). Pavlatos further teaches a goal of developing ultrasound speckle tracking methods (Chapter 1: Ultrasound Speckle Tracking) for observing changes in the optical nerve head (Chapter 1, Specific Aims) and providing insight into the disease process of glaucoma (Chapters 2-4). Pavlatos further discloses wherein a data acquisition window associated with the ultrasound data is centered around an optic nerve head of the eye (Chapter 3: Inflation Testing, Segmentation and Regional Analyses; fig. 3.3 B).
While Pavlatos discloses experimental processes, the stated aim of using the speckle tracking approach to improve diagnostics for eye diseases such as glaucoma would provide sufficient motivation such that it would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to apply the imaging and speckle tracking method of Liu and Lim to a data acquisition window centered around an optic nerve head in view of the teachings of Pavlatos.
Regarding claim 5: Liu in view of Lim discloses the method of claim 1, but are silent on wherein the measurement of the posterior portion of the eye of the subject comprises a measure of tissue thickness.
Pavlatos, in the same field of endeavor, teaches that glaucoma is conventionally diagnosed using a combination of optical nerve head imaging and visual field testing, and that early identification of changes to the optical nerve head structure is critical in diagnosing and monitoring glaucoma (Chapter 1: Glaucoma Biomechanics). Pavlatos further teaches a goal of developing ultrasound speckle tracking methods (Chapter 1: Ultrasound Speckle Tracking) for observing changes in the optical nerve head (Chapter 1, Specific Aims) and providing insight into the disease process of glaucoma (Chapters 2-4). Pavlatos further discloses wherein the measurement of the posterior portion of the eye of the subject comprises a measure of tissue thickness (fig. 3.2 A; the posterior eye through-thickness strain measurements would inherently include "a measure of tissue thickness" since strain is calculated as a ratio of the change in a dimension [e.g. thickness] to the original dimension [e.g. thickness]).
While Pavlatos discloses experimental processes, the stated aim of using the speckle tracking approach to improve diagnostics for eye diseases such as glaucoma would provide sufficient motivation such that it would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to apply the imaging and speckle tracking method of Liu and Lim to include a measure of tissue thickness in view of the teachings of Pavlatos.
Regarding claim 6: Liu in view of Lim discloses the method of claim 1, but are silent on wherein the measurement of the posterior portion of the eye of the subject comprises anatomic measurements.
Pavlatos, in the same field of endeavor, teaches that glaucoma is conventionally diagnosed using a combination of optical nerve head imaging and visual field testing, and that early identification of changes to the optical nerve head structure is critical in diagnosing and monitoring glaucoma (Chapter 1: Glaucoma Biomechanics). Pavlatos further teaches a goal of developing ultrasound speckle tracking methods (Chapter 1: Ultrasound Speckle Tracking) for observing changes in the optical nerve head (Chapter 1, Specific Aims) and providing insight into the disease process of glaucoma (Chapters 2-4). Pavlatos further discloses wherein the measurement of the posterior portion of the eye of the subject comprises anatomical measurements (tissue thickness is an “anatomical measurement”; fig. 3.2 A; the posterior eye through-thickness strain measurements would inherently include a measure of tissue thickness since strain is calculated as a ratio of the change in a dimension [e.g. thickness] to the original dimension [e.g. thickness]).
While Pavlatos discloses experimental processes, the stated aim of using the speckle tracking approach to improve diagnostics for eye diseases such as glaucoma would provide sufficient motivation such that it would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to apply the imaging and speckle tracking method of Liu and Lim to include a measure of tissue thickness in view of the teachings of Pavlatos.
Regarding claim 10: Liu in view of Lim discloses the method of claim 7. Liu further discloses determining a diagnosis based on the measurement of the eye ([0005], [0007], [0041]) and that biomechanical properties may be indicative of changes related to glaucoma ([0045]).
Pavlatos, in the same field of endeavor, teaches that glaucoma is conventionally diagnosed using a combination of optical nerve head imaging and visual field testing, and that early identification of changes to the optical nerve head structure is critical in diagnosing and monitoring glaucoma (Chapter 1: Glaucoma Biomechanics). Pavlatos further teaches a goal of developing ultrasound speckle tracking methods (Chapter 1: Ultrasound Speckle Tracking) for observing changes in the optical nerve head (Chapter 1, Specific Aims) and providing insight into the disease process of glaucoma (Chapters 2-4). Pavlatos further teaches that the mechanical characteristics of the ONH and their interplay with IOP are important factors in glaucoma development and progression (Chapters 2 and 4). Based on these teachings, and the stated aim of Pavlatos of using the speckle tracking approach to improve diagnostics for eye diseases such as glaucoma would provide sufficient motivation such that it would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the diagnosis as comprising glaucoma.
Regarding claim 11: Liu in view of Lim discloses the method of claim 1. Liu further discloses determining a diagnosis based on the measurement of the eye ([0005], [0007], [0041]) and that biomechanical properties may be indicative of changes related to glaucoma ([0045]).
Pavlatos, in the same field of endeavor, teaches that glaucoma is conventionally diagnosed using a combination of optical nerve head imaging and visual field testing, and that early identification of changes to the optical nerve head structure is critical in diagnosing and monitoring glaucoma (Chapter 1: Glaucoma Biomechanics). Pavlatos further teaches a goal of developing ultrasound speckle tracking methods (Chapter 1: Ultrasound Speckle Tracking) for observing changes in the optical nerve head (Chapter 1, Specific Aims) and providing insight into the disease process of glaucoma (Chapters 2-4). Pavlatos further teaches that the mechanical characteristics of the ONH and their interplay with IOP are important factors in glaucoma development and progression (Chapters 2 and 4). Based on these teachings, and the stated aim of Pavlatos of using the speckle tracking approach to improve diagnostics for eye diseases such as glaucoma would provide sufficient motivation such that it would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the diagnosis as comprising glaucoma, where it is considered to be implicitly disclosed that the measurement/diagnosis “comprises a degree of glaucoma progression” since there is no requirement in the claim to provide a specific diagnosis or value corresponding to the “degree of…progression.”
Claim(s) 8-9 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu and Lim as applied to claims 1 and 7 above, and further in view of Tang, Junhua, and Jun Liu. "Ultrasonic measurement of scleral cross-sectional strains during elevations of intraocular pressure: method validation and initial results in posterior porcine sclera." (2012): 091007 (hereinafter “Tang”).
Regarding claims 8-9: Liu in view of Lim disclose the method of claim 7, but are silent on the diagnosis comprising myopia or a degree of myopia progression.
Tang, in the same field of endeavor, teaches that characterization of scleral biomechanical properties is important for understanding prevalent ocular diseases such as glaucoma and myopia, including disease progression (1.3 Corneal and scleral biomechanics, 4.1 Introduction) which can be performed using speckle tracking ultrasound strain measurements (4.2.2 Ultrasound speckle tracking algorithm). While Tang discloses experimental processes, the disclosure of the application of the speckle tracking strain measurements to myopia would provide sufficient motivation such that it would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to apply the imaging and speckle tracking method of Liu and Lim to diagnosing myopia or a degree of myopia progression.
Regarding claim 17: Liu in view of Lim discloses the method of claim 1, including filtering the data according to the frequency of the ultrasound data ([0034]). However, Liu and Lim are silent on optimizing the speckle tracking algorithm to a frequency of the ultrasound data.
Tang, in the same field of endeavor, teaches that optimization of a speckle tracking algorithm to a frequency of the ultrasound data is well-known (1.4 Ultrasound elastography - "The relationship between the SNR and the strain can be affected by system characteristics (e.g., transducer center frequency and bandwidth), the signal-to-noise ratio in the raw radiofrequency (RF) signals, or the signal processing parameters (e.g., kernel size and overlap) during ultrasound speckle tracking [167, 170]. It is thus possible to choose appropriate transducers for specific applications or tune the signal processing parameters for the optimal performance").
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Liu and Lim by optimizing the speckle tracking algorithm in view of the teachings of Tang in order to provide improved results as compared to a non-optimized algorithm.
Response to Arguments
Rejection of claims 1-17 under 35 U.S.C. §112(a) is withdrawn in light of the amendment to claim 1.
Applicant’s arguments with respect to rejection of claims 18-21 under 35 U.S.C. §112(a), filed 12/23/2025, have been fully considered but are not persuasive.
Applicant argues that "these elements are squarely and explicitly supported in the original disclosure," with respect to the reference images and deformed images as well as the temporal sequence in which they are acquired. Applicant asserts that support is present in fig. 1 and paragraphs [0039]-[0044]. Applicant alleges that this portion of the specification describes
Acquiring ultrasound data of the posterior portion of the eye over time where the reference
images serve as baseline and the deformed images are subsequent frames. Applicant asserts
that this means the claimed limitations are inherently supported.
Examiner respectfully disagrees. First, paragraph [0039] states that the acquired ultrasound data "is maybe of the posterior eye." Second, while these paragraphs mention "a reference image" ([0041] - "A region of interest is defined in a reference image."; [0042] - "the reference and deformed images (e.g., those due to a pulsation resulting from a heartbeat) are compared."), but never describes what the reference image is or where it comes from. There is no indication that the reference image is an image acquired prior to deformation. It is not even clearly established that the "reference image" is from the patient - "a reference image" could be any kind of image for comparison such as a standard image, an atlas image, an image depicting a desired tissue response, etc. Third, while "deformed images" are disclosed, there is no indication as to when these images are acquired relative to any reference image. That the "reference image" is acquired first and the "deformed image" is acquired second is not inherent - a deformed image could be acquired first while a reference image could be acquired afterwards when the tissue has returned to its relaxed state. Finally, while Applicant alleges that the reference images "serve as a baseline," there is no such description or reference to a baseline condition. The only disclosure regarding the reference images is that they exist and they are compared to the deformed images. The rejection is maintained.
Applicant’s arguments regarding prior art rejections of all pending claims, filed 12/23/2025, have been fully considered but are moot in view of the updated grounds of rejection necessitated by amendment. However, certain of Applicant’s arguments will be addressed in the interest of advancing prosecution.
Applicant alleges that Liu “describes changing intraocular pressure or using external loading to assess stiffness” and that “Liu’s teaches relative motion arises from controlled intraocular pressure changes and externally induced or manipulated pressure profiles.” Applicant cites Liu paragraph [0031] as support for these assertions.
Examiner respectfully disagrees. Liu clearly and explicitly discloses performing elastography and measuring strain based on the ocular pulse: Abstract – “[t]his invention describes an ultrasound technique that maps out the mechanical properties of the cornea and the sclera to the intrinsic mechanical loadings in the eye”, [0006]-[0010] – ocular pulse, [0022] – “spatial mapping of the mechanical strains developed in the cornea or the sclera during ocular pulse”, [0032] – “…outputs the distributive strain data of a given cross-section of at least one portion of the eye as a function of time during the ocular pulse”, [0052] – “[d]uring ocular pulse, the strains corresponding to a small fluctuation of the IOP are recorded using the high frequency ultrasound elastography technique.” The only reference in Liu to “external loading” is in a description of known techniques for performing ultrasound strain mapping which is presented in paragraph [0033], and the entire context is a statement that “[t]issue deformation needs to be induced either by intrinsic forces or external forces.” This is in no way a disclosure of the method of Liu using external loading; it is merely a description of the generalities of strain mapping as it has been performed by others. With respect paragraph [0031] cited by Applicant as supporting “Liu’s teaches relative motion arises from controlled intraocular pressure changes and externally induced or manipulated pressure profiles,” this paragraph contains a description of a measurement of IOP and ocular pulse that is taken in conjunction with the ultrasound acquisition and that is used during the data analysis. There is nothing in this paragraph to suggest that Liu relies on external loading. While Liu does provide that IOP changes can be the result of things like changing position or fluid intake, Liu also clearly states that “[t]he IOP fluctuations could be ocular pulse.”
Applicant argues that Lim “teaches a different modality (manual compression)” and that Lim “fundamentally differs from Lui [sic].”
Examiner respectfully disagrees that the source of the loading renders the elastography of Lim a “different modality” than the elastography of Liu. First and foremost, almost the entirety of Applicant’s arguments regarding the Liu reference (see above) revolve around the allegation that Liu uses external loading. It is difficult to understand how Applicant can assert that Liu uses external loading and then say that Lim cannot be combined with Liu because Lim uses external loading (“manual compression”) and is therefore a different modality. These are contradictory statements and cannot both be true. Second, elastography can encompass either intrinsic or external loading (see Liu paragraph [0033]). There are not two separate modalities of elastography based on the source of the loading, merely variations of the same modality.
Applicant goes on to characterize the rejection over Liu and Lim as “[t]he combination proposed in the Office Action essentially takes Liu's general elastographic framework and Lim's use of a 20 MHz probe and manual compression for posterior wall strain, and then retrofits the combination to Applicants' detailed posterior-eye ocular pulse elastography (OPE) framework.”
Examiner respectfully disagrees. This characterization of the rejection of record is entirely inaccurate. There is absolutely no suggestion anywhere in the Office Action that Lim’s manual compression is being in any way incorporated into or combined with the method of Liu. The ONLY modification in the rejection of record over Liu and Lim is to use the 20 MHz probe of Lim rather than the 50MHz probe of Liu. It is very well-known in the art that a wide range of ultrasound transducer frequencies may be applied to ophthalmic ultrasound (as evidenced by Silverman, Ronald H. "Principles of ophthalmic ultrasound." Expert review of ophthalmology 18.6 (2023): 379-389; see Table 1) and it would have been evident to one having ordinary skill in the art that another transducer frequency could be selected with only predictable results.
Applicant goes on to argue that “[t]he references themselves do not suggest such a combination and it would further change a principal operation of the Lim reference which is impermissible under MPEP §2143.01. Nothing in Lim suggests discarding its manual compression approach in favor of using intrinsic ocular pulse, nor does Lim suggest adopting Liu's specific algorithmic structure for posterior-eye diagnosis of both myopia and glaucoma.”
Again, Examiner asserts that this is a complete mischaracterization of the rejection of record. Nowhere is “discarding” the manual compression of Lim even suggested much less relied a upon in a rejection, nor is there anything even approaching a suggestion for Lim “adopting Liu's specific algorithmic structure for posterior-eye diagnosis of both myopia and glaucoma.” As stated previously, the ONLY modification with respect to the combination of the Liu and Lim references is performing the method of Liu with a different, but still very well-known and conventional, frequency. There is nothing to support an assertion that using a lower frequency probe to perform the method of Liu would impermissibly change the principle of operation. With respect to Applicants reference to Lim “adopting Liu's specific algorithmic structure for posterior-eye diagnosis of both myopia and glaucoma,” this statement does not appear to be relevant to any grounds of rejection presented in this or any other Office Action.
Applicant argues that Liu and Pavlatos do not teach performing claimed techniques on the posterior portion of the eye.
Examiner respectfully disagrees. As Applicant notes, Liu discloses performing the speckle tracking and strain measurement on the sclera, where Applicant has defined the sclera as being a portion of the eye behind the anterior hyaloid membrane at paragraph [0003] of the instant disclosure (“[t]he posterior eye can be defined as the structures behind the anterior hyaloid membrane of the eye. This can include the retina, choroid, sclera, and optic nerve, as well as the vitreous humor surrounding the retina.” emphasis added).
Applicant argues that “[t]he OPE technique of Pavlatos is limited to the cornea and anterior eye. While Pavlatos does describe high-frequency ultrasound and speckle tracking, there is no teaching or suggestion of applying the disclosed technique to posterior portions of the eye. In particular, the posterior portion of the eye have significantly different acoustic, structural, and biomechanical characteristics that are not considered by Pavlatos.”
Examiner respectfully disagrees. Pavlatos repeatedly and explicitly describes applying elastography to posterior eye structures (even simply keyword searching Pavlatos reveals four hundred references to “ONH” or optical nerve head). Chapters 2-4 of Pavlatos discusses in detail applying the elastography techniques to the sclera surrounding the optic nerve head (see at least figs. 2.3 and 2.6 – 2.10), while Chapter 1 includes a detailed discussion of the “acoustic, structural, and biomechanical characteristics” of the posterior portion of the eye.
Applicant argues that "Tang is only applicable for ex vivo study" and therefore cannot be combined with Liu or Lim.
Examiner respectfully disagrees. While Tang describes validation experiments performed on ex vivo tissue, the explicitly stated intent of Tang is to develop in vivo diagnostic techniques for assessment of the sclera and any skilled artisan would understand that the next step after the laboratory phase would be to develop the technique for in vivo use. The use of ex vivo tissue during the experimental phase does not preclude the application of the technique in vivo.
Applicant is further reminded that many of the instant claims are so broad that they can reasonably encompass any manner of performing the claimed acts. E.g. claim 8 which recites only “[t]he computer-implemented method of claim 7, wherein the diagnosis comprises myopia,” where claim 7 recites “[t]he computer-implemented method of claim 1, further comprising determining a diagnosis based on the measurement of the posterior portion of the eye of the subject.” The only difference between the steps of claim 1 and the steps of Liu is the frequency of the ultrasound probe. There are no steps set forth for either of claims 7 or 8 beyond simply “determining a diagnosis” based on the data acquired in claim 1. If Applicant truly intends to claim a novel method of determining a diagnosis in a specific way that would patentably define over the prior art, Applicant must present some level of detail beyond merely “determining a diagnosis.” Any skilled artisan would be aware that one could determine a diagnosis and that diagnosis could be of myopia based on the art available prior to the time of filing. Applicant repeatedly argues details which are not relevant to anything in the claims (e.g. the assertion that “the posterior portion of the eye have significantly different acoustic, structural, and biomechanical characteristics that are not considered by Pavlatos” when the claims do not present any limitations or steps which would define over the prior art).
Conclusion
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/CAROLYN A PEHLKE/ Primary Examiner, Art Unit 3799