Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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
Claims 1-16 and 21-23 are rejected under 35 U.S.C. 101 because
the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the steps of: 1) receiving OCT data, 2) receiving imaging data from a camera, and 3) characterizing the inhomogeneity. This judicial exception is not integrated into a practical application because steps could be carried out by a human being with no more than pen and paper (an indication of an abstract idea). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because: 1) the method claims contain no additional elements and 2) claims 21-23 add only generic well known elements (OCT, camera, processor, laser source, device arm, application head).
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 3 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the cataract grade" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 depends directly on claim 1, and claim 1 does not recite a cataract grade. Claim 2 does recite a cataract grade. Therefore in order to provide an initial examination and search the examiner will interpret claim 3 as depending directly from claim 2.
Claim 17 recites the limitation "the cataract grade" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 depends directly on claim 1, and claim 1 does not recite a cataract grade. Claim 2 does recite a cataract grade. Therefore in order to provide an initial examination and search the examiner will interpret claim 17 as depending directly from claim 2.
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.
Claims 1, 7-9, 11, 15-16, 21, and 23 are rejected under 35 U.S.C. 102(a)(2) as anticipated by Thoe et al. (U.S. Patent Application Publication 2022/0031512) or, in the alternative, under 35 U.S.C. 103 as obvious over Li et al. ("Simultaneous optical coherence tomography and Scheimpflug imaging using the same incident light", OPTICS EXPRESS, vol. 28, no. 26, 12/16/2020 (pgs. 39660-39676) ) (prior art from IDS).
Regarding claim 1, Thoe et al. disclose a laser system and method for taking measurements of the eye, specifically the cornea and the lens. Thoe et al. disclose the method comprising:
receiving one or more of imaging modality data including:
optical coherence tomography data of the eye (see [0028]); and
image data of an image of the eye recorded by a camera, the image recorded using Scheimpflug imaging (along with its illumination see [0028]); and
characterizing a cataract using the optical coherence tomography data and the image data (see “type of the cataract (e.g., nucleolus, posterior, anterior cataract) is determined,” [0052]).
Since Thoe et al. disclose the use of more than one imaging modality and they disclose OCT and Scheimpflug imaging it anticipates the claimed invention.
Alternatively, although Thoe et al. do not single out the combination of both OCT and Scheimflug imagers used together, like Thoe et, Li et al. disclose a method of taking measurements of the eye, the cornea using a laser and teach the simultaneous use of both OCT and Scheimflug imagers in order to measure the same tissue at the same time with a single measurement using the same illumination source (thus providing an economical benefit of one illumination source over two illumination sources (see abstract).
Regarding claim 7, Thoe et al. disclose the claimed invention including “characterizing
the optical inhomogeneity type comprises using a decision tree” (see figure 2A).
Regarding claims 8-9, Thoe et al. disclose the claimed invention including wherein characterizing the optical inhomogeneity type includes using a machine learning model (see [0026]-[0027], [0037] for example). With respect to the claim 9, Thoe et al. disclose the received input of the optical coherence tomography data and the image data (as shown above in the rejection of claim 1, [0028]) and generates the output of the optical inhomogeneity in the form of cataract ([0052]).
Regarding claim 11, Thoe et al. disclose the claimed invention including the machine
learning model is a machine learning model trained using supervised learning ([0069], [0079] for example) and a training dataset ([0026], [0069], [0079], [0087] for example) comprising optical coherence tomography data, image data, and a labelled optical inhomogeneity type (in the form of cataract [0026], [0087] for example) of a plurality of patients ([0027], [0079], [0087] for example).
Regarding claim 15, Thoe et al. disclose the claimed invention including “adapting a treatment pattern for laser treatment of the eye using the optical inhomogeneity type – i.e. the cataract, see
“the pre-operative data including imaging data associated with the lens of the eye, determining a lens density map based on the imaging data associated with the lens, and generating laser fragmentation patterns for a laser fragmentation procedure based on the lens density maps” [abstract], and
“obtaining pre-operative diagnostic images and/or other data for a patient and, e.g., automatically, providing a recommended fragmentation pattern” ([0021]).
Regarding claim 16, Thoe et al. disclose the claimed invention including “the treatment pattern comprises a sequence of treatment points, each treatment point having associated therewith a location and laser beam parameters, and adapting the treatment pattern comprises adjusting one or more of: the location or the laser beam parameters, for one or more treatment points, depending on one or more of: the cataract grade, the optical coherence tomography data, or the image data,” see “the spots” ([0019], and [0038].
Regarding claim 21, Thoe et al. disclose a system comprising:
an optical coherence tomography system (see [0028]); and
a camera (Scheimpflug camera along with its illumination see [0028]); and
at least one processor (at least the processor for “the one or more computing devices 140,” see [0045] and figure 1, and also see the software programming in [0006]) configured to:
receive optical coherence tomography data of an eye (see [0028]);
receive image data of an image of the eye recorded by the camera (Scheimpflug camera along with its illumination see [0028]), the image recorded using Scheimpflug imaging; and
characterize an optical inhomogeneity as a cataract using the received optical coherence tomography data and the received image data (see “type of the cataract (e.g., nucleolus, posterior, anterior cataract) is determined,” [0052]).
Since Thoe et al. disclose the use of more than one imaging modality and they disclose OCT and Scheimpflug imaging it anticipates the claimed invention.
Alternatively, although Thoe et al. do not single out the combination of both OCT and Scheimflug imagers used together, like Thoe et, Li et al. disclose a method of taking measurements of the eye, the cornea using a laser and teach the simultaneous use of both OCT and Scheimflug imagers in order to measure the same tissue at the same time with a single measurement using the same illumination source (thus providing an economical benefit of one illumination source over two illumination sources (see abstract).
Regarding claim 23, Thoe et al. disclose a computer program (see [0006]) configured to control at least one processor (at least the processor for “the one or more computing devices 140,” see [0045] and figure 1, and also see the software programming in [0006]) to perform:
receiving optical coherence tomography data of an eye (see [0028]);
receiving image data of an image of the eye recorded by a camera using Scheimpflug imaging (“Scheimpflug camera” [0028]),
characterizing an optical inhomogeneity as a cataract using the received optical coherence tomography data and the received image data (see “type of the cataract (e.g., nucleolus, posterior, anterior cataract) is determined,” [0052]).
Since Thoe et al. disclose the use of more than one imaging modality and they disclose OCT and Scheimpflug imaging it anticipates the claimed invention.
Alternatively, although Thoe et al. do not single out the combination of both OCT and Scheimflug imagers used together, like Thoe et, Li et al. disclose a method of taking measurements of the eye, the cornea using a laser and teach the simultaneous use of both OCT and Scheimflug imagers in order to measure the same tissue at the same time with a single measurement using the same illumination source (thus providing an economical benefit of one illumination source over two illumination sources (see abstract).
Claims 2-3, 5-6, 12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Thoe et al. (U.S. Patent Application Publication 2022/0031512)(with and/or without the teaching of Li et al.) as applied to claim 1 above, and further in view of Nixon (U.S. Patent 8,360,577).
Regarding claim 2, Thoe et al. show the method above,
but fail to recite characterizing the optical inhomogeneity type further includes characterizing a cataract grade of the cataract.
Like Thoe et al., Nixon discloses a laser surgery diagnostic method and teach further characterizing cataracts with “a grade for the cataract based on the comparison of the optical density of the lens and a volume of the first template” (see abstract) so “pre-operative grading allows for the pre-programming of cataract surgical equipment to ideally match a grade of the cataract to an appropriate energy setting and fluid setting to most efficiently remove the cataract,” (see col. 1:17-25).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Thoe et al. (with and/or without Li et al.), as taught by Nixon, to provide a characterization of the cataract with a grade “based on the comparison of the optical density of the lens and a volume of the first template” so that the “pre-operative grading allows for the pre-programming of cataract surgical equipment to ideally match a grade of the cataract to an appropriate energy setting and fluid setting to most efficiently remove the cataract.”
Regarding claim 3, Thoe et al. (with and/or without Li et al.)in view of Nixon disclose (or make obvious) the claimed invention including “the cataract grade includes a cataract type comprising one or more of: a nuclear sclerotic cataract, a cortical spoking cataract, or a posterior subcapsular cataract; optionally the cataract grade includes a cataract severity level associated with at least one of the one or more cataract types,” see Nixon “posterior subcapsular cataract” in col. 1:26-45.
Regarding claims 5-6, Thoe et al. (with and/or without Li et al.) show the method above,
but fail to recite “wherein characterizing the optical inhomogeneity types comprises: generating a three-dimensional representation of at least part of the eye using one or more of: the optical coherence tomography data~ or the image data identifying one or more volume segments of opacity in the eye using the three-dimensional representation, preferably including, for at least one volume segment, a location in the eye, a three-dimensional size, a three-dimensional shape, a degree of opacity, or a distribution of opacity, and characterizing, in the processor, the optical inhomogeneity using the one or more volume segments.”
From a review of [0105] of Applicant’s specification (U.S. Patent Application Publication 2024/0206726), discloses “to identify volume segments of opacity” is equivalent “to identify the volume segments of opacity.”
or to identify a volume of a cataract.
So an volume segment is just an volume of opacity in the eye, which is met or satisfied by a volume of a cataract in the eye.
Like Thoe et al., Nixon discloses a laser surgery diagnostic method using OCT and teach using the volume of the cataract and its mean optical density in order to categorize the grade of the cataract (see col. 4:66 through col. 5:13 and figure 3) so “pre-operative grading allows for the pre-programming of cataract surgical equipment to ideally match a grade of the cataract to an appropriate energy setting and fluid setting to most efficiently remove the cataract,” (see col. 1:17-25).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Thoe et al. (with and/or without Li et al.), as taught by Nixon, to use the volume of the cataract and its mean optical density in order to categorize the grade of the cataract so “pre-operative grading allows for the pre-programming of cataract surgical equipment to ideally match a grade of the cataract to an appropriate energy setting and fluid setting to most efficiently remove the cataract.”
Additionally, Thoe et al. fail to recite “wherein characterizing the optical inhomogeneity types comprises: identifying one or more area segments of opacity in the eye using one or more of: the optical coherence tomography data, or the image data, preferably including, for at least one area segment, one or more of: a location in the eye, a two-dimensional size, a two-dimensional shape, a degree of opacity, or a distribution of opacity, and characterizing the optical inhomogeneity using the one or more area segments.”
From a review of [0008] of Applicant’s specification (U.S. Patent Application Publication 2024/0206726), discloses “area segments 71 corresponding to areas of opacity in the eye.”
So an area segment is just an area of opacity in the eye, which is met or satisfied by an area of a cataract in the eye.
Since Nixon additionally disclose sizes (or lengths, in mm) see col. 5:14-52, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Thoe et al. (with and/or without Li et al.), as taught by Nixon, to use the area of the cataract (which is just volume divided by length) and its mean optical density in order to categorize the grade of the cataract so “pre-operative grading allows for the pre-programming of cataract surgical equipment to ideally match a grade of the cataract to an appropriate energy setting and fluid setting to most efficiently remove the cataract.”
Regarding claim 12, Thoe et al. (with and/or without Li et al.) in view of Nixon disclose (or make obvious) the claimed invention including “the method
further comprises displaying on a display an indicator of the optical
inhomogeneity type.”
Like Thoe et al., Nixon discloses a laser surgery diagnostic method using OCT and teach displaying the grade of a cataract on the display (see col. 4: 60-65, col. 6:35-44 and figure 1 step 24) in order to provide a known and workable manner of informing the user/operator of the classification of the cataract.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Thoe et al. (with and/or without Li et al.), as taught by Nixon, to display on the display monitor/screen the grade of a cataract on the display in order to provide a known and workable manner of informing the user/operator of the classification of the cataract.
Regarding claim 17, Thoe et al. in view of Nixon disclose (or make obvious) the claimed invention including “the method further comprises receiving supplementary patient information including one or more of the following: an age of the patient, a sex of the patient, a visual acuity of the eye of the patient, one or more symptoms of the patient, or a medical history of the patient, and wherein characterizing the cataract grade further comprises using the supplementary patient information,” see Thoe et al. [0051] for example.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Thoe et al. (U.S. Patent Application Publication 2022/0031512) )(with and/or without the teaching of Li et al.) as applied to claim 1 above, and further in view of Morley et al. (U.S. Patent 10,709,610).
Regarding claim 4, Thoe et al. (with and/or without Li et al.) show the method above,
but fail to recite “wherein the optical coherence tomography data includes one or more B-scans, preferably two or more B-scans arranged plane parallel to each other, or two or more B-scans rotated radially with respect to each other about an optical axis.”
From a review of [0008] of Applicant’s specification (U.S. Patent Application Publication 2024/0206726), discloses “many one-dimensional scans (A-scans) are performed at several positions (in particular lateral positions) along a pre-determined path in the eye. These A-scans can then be combined to form two-dimensional cross-sections of the eye (or parts thereof) in so-called B-scans.”
So B-scan is just a two-dimensional scan. It should be noted this is extremely well known in the laser eye treatment arts.
Like Thoe et al., Morley et al. discloses a laser surgery diagnostic method using OCT and teach providing the method with two-dimensional scanning (see col. 6:49-67) in order to provide an known and workable manner of scanning the eye for both 1) the treatment beam (see col. 6:49-67), and 2) the imaging beam (e.g., OCT) (see col. 6:49-67, col. 8:38 through col. 9:12) to provide pre-operative diagnostics regarding the eye.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Thoe et al. (with and/or without Li et al.), as taught by Morley et al., to provide the method with two-dimensional scanning (one or more B-scans) in order to provide an known and workable manner of scanning the eye for both 1) the treatment beam, and 2) the imaging beam (e.g., OCT) to provide pre-operative diagnostics regarding the eye.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Thoe et al. (U.S. Patent Application Publication 2022/0031512) )(with and/or without the teaching of Li et al.) as applied to claim 8 above, and further in view of Zhang et al. (Machine learning for cataract classification/grading on ophthalmic imaging modalities: a survey. Machine Intelligence Research, vol. 19, no. 3, pp.184-208, June 2022) (prior art from IDS).
Regarding claim 10, Thoe et al. show the method above including the use of machine learning in the form neural networks (see [0027], [0069]) for example) or deep neural networks (see [0095]),
but fail to recite the machine learning model comprises a convolutional neural network.
Like Thoe et al., Zhang et al. discloses a laser surgery diagnostic method using OCT and machine learning in the form of deep neural network teach providing convolutional neural network (CNN) in order to classify/grade cataracts based on ophthalmic images (see page 192, the 1st paragraph of section 5.2 Deep learning methods) and also in order to provide a known and workable classifying and grading cataracts.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Thoe et al. (with and/or without Li et al.), as taught by Zhang et al., to provide the method with convolutional neural network (CNN) in order to classify/grade cataracts based on ophthalmic and also in order to provide a known and workable classifying and grading cataracts.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Thoe et al. (U.S. Patent Application Publication 2022/0031512) )(with and/or without the teaching of Li et al.) in view of Holland et al. (U.S. Patent Application Publication 2024/0167524).
Regarding claim 22, Thoe et al. disclose a system comprising:
an optical coherence tomography system (see [0028]); and
a camera (Scheimpflug camera along with its illumination see [0028]); and
at least one processor (at least the processor for “the one or more computing devices 140,” see [0045] and figure 1, and also see the software programming in [0006]) configured to:
receive optical coherence tomography data of an eye (see [0028]);
receive image data of an image of the eye recorded by the camera (Scheimpflug camera along with its illumination see [0028]), the image recorded using Scheimpflug imaging; and
characterize an optical inhomogeneity as a cataract using the received optical coherence tomography data and the received image data (see “type of the cataract (e.g., nucleolus, posterior, anterior cataract) is determined,” [0052]).
Thoe et al. fail to disclose the system comprises:
1) a base station having a laser source configured to generate a laser beam;
2) an arm connected to the base station configured to provide a beam path for the laser beam; and
3) an application head configured to direct the laser beam into an eye of a patient.
Like Thoe et al., Holland et al. disclose a system comprising OCT or Scheimpflug and teach providing the system with a treatment system having:
1) a base station (“laser assembly 12,” see col. 8:15-45 and figures 1-2) having a laser source (“IR laser 32,” see col. 8:15-45 and figures 1-2) configured to generate a laser beam;
2) an arm (“free-floating mechanism 16,” see col. 6:30-62 and figures 1-2) connected to the base station configured to provide a beam path for the laser beam; and
3) an application head (“patient interface 22,” see col. 4:59 through col. 5:7 and figure 1) configured to direct the laser beam into an eye of a patient,
in order to provide a known and workable manner of providing laser treatment system for extracting diagnosed cataracts (see abstract, and col. 54-67 for example).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Thoe et al. (with and/or without Li et al.), as taught by Holland et al., to provide the system with a treatment system having:
1) a base station having a laser source configured to generate a laser beam;
2) an arm connected to the base station configured to provide a beam path for the laser beam; and
3) an application head configured to direct the laser beam into an eye of a patient,
in order to provide a known and workable manner of providing laser treatment system for extracting diagnosed cataracts.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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/AARON F ROANE/Primary Examiner, Art Unit 3792