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 .
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) 2-4, 9-10, 12, 15 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Izatt et al. US 2014/0354951 as evidenced by Applicant Admitted Prior Art (AAPA).
For claim 2, Izatt teaches a method of imaging an irido-corneal angle of the eye having a cornea ([0032]). Applicant’s figures ’s 1-5 labeled as Prior Art includes anatomical structure of eye with an iris, an anterior chamber, and irido-corneal angle, and a direction of view. As such, any eye would necessarily include all of the anatomical features as disclosed in Prior Art figures 1-5 and [0005]-[0010] of the specification. Izatt teaches the method comprising:
directing an OCT beam along an optical path through a corneal angle wherein the beam along the optical path is offset from the direction of view ([0032] and figure 1 of Izatt wherein light beam enters prism GC in conical portion so as to be redirected at the exit surface CA of the contact lens and at an angle from the direction of view (being along the axis of the cone shaped portion of the contact lens));
aligning the OCT beam with an initial segment of ocular tissue of the irido-corneal angle (“delivering a tightly-focused OCT beam from a conventional OCT x-y scan head through the cornea and into the irido-corneal angle in a fully circumferential scannable geometry” in para. [0032]); See segmentation in figures 4C for radial segmentation and 4B c for circumferential segmentation and description in paras. [0047] and [0048]
obtaining an initial circumferential OCT image of the initial segment of ocular tissue (“one or more B-scans obtained while scanning the focused spot in a circular pattern around the circumference of the irido-corneal angle” in para.[0047],); and
for each of one of one or more additional segments of ocular tissue, aligning the OCT beams with the additional segment and obtaining an additional circumferential OCT image of the additional segment (“a series (10-1000) of sequential circumferential-priority scans with different radii may be obtained in order to collect a volume of data including all relevant outflow structures” in para. [0047] and claim 9, which teaches the segments may be assembled to produce one image).
For claim 15, Izatt teaches a method of imaging an irido-corneal angle, the method comprising directing an OCT beam along an optical path through a corneal angle wherein the beam along the optical path is offset from the direction of view, see figure 1 of Izatt wherein light beam enters prism GC in conical portion so as to be redirected at the exit surface CA of the contact lens and at an angle from the direction of view ( being along the axis of the cone shaped portion of the contact lens)
aligning the OCT beam at a circumferential point (see fig, 4B for boundaries of the circumferential points) and acquiring an image at each point and
obtaining an initial circumferential OCT image at each point (segment) and constructing a circumferential image based upon the obtained image data. - see para. [0035].
For claims 3 and 4, in para. [0035], the initial and additional segments are assembled either for a partial construction or full construction which an example of processing explained in Para. [0038], wherein segments of A scans which may be circumferential (or radial), are assembled either for a partial image or full (image) which is an example of processing of the segments to construct an image. In para. [0038] “Other embodiments of the present disclosure provide for methods for segmenting, processing, and displaying the resulting image set.” For the limitation of real time displaying, Applicant teaches an example of “real-time” imaging in Applicant’s specification at para. [0157] and others, “The obtained 2D or 3D circumferential image may be displayed in real-time, delayed by the time it takes to construct the 2D or 3D”. Thus “real time” according to Applicant specification is not the displaying of segments at the moment they are imaged, but rather a delayed time after the segment images are taken and then assembled to form a display image. Thus, the segmenting processing (assembling) and displaying of the images in Izatt, is the same sequence of events as described in Applicant’s specification with the same delays. Therefore, the Izatt disclosure is considered to meet “real -time” displaying of images because it too involves delays from when the segments are first imaged until they are assembled and ready for display. Applicant’s do not provide any time restrictions on what that time delay may be.
Regarding claim 4, para. [0047] includes the following:
The circumferential-priority scan pattern, illustrated in FIG. 4B, is comprised of one or more B-scans obtained while scanning the focused spot in a circular pattern around the circumference of the irido-corneal angle. If the subject's eye remains sufficiently stationary, a single or a few sequential circumferential B-scans may be positioned to view the entire circumference of circular structures such as Schlemm's canal.
For claim 9, obtaining an initial azimuthal OCT image of the initial segment of ocular tissue and additional azimuth image of each of the one or more additional segments of ocular tissue correspond to the radial segments in fig. c and paras.[0037] and [0048].
For claim 10, in para. [0035], segments of A scans which may be circumferential (or radial), are assembled either for a partial image or full (image) which is an example of processing of the segments to construct an image. In para. [0038], other embodiments of the present disclosure provides for methods for segmenting, processing (e.g. assembling) and displaying the resulting image set. An example of “real-time” imaging is taught in Applicant’s specification at para. [0157] and others, “The obtained 2D or 3D circumferential image may be displayed in real-time, delayed by the time it takes to construct the 2D or 3D”. Thus “real time” according to Applicant specification is not the displaying of segments at the moment they are imaged, but rather a delayed time after the segment images are taken and then assembled to form a display image. Thus, the segmenting processing (assembling) and displaying of the images in Izatt, is the same sequence of events as described in Applicant’s specification. Therefore, the Izatt disclosure is considered to meet “real-time” displaying of images because it too involves delays from when the segments are first imaged until they are assembled and ready for display. Applicant’s do not provide any time restrictions on what that time delay may be.
For claim 12, adding addition circumferential images and assembling together as in para. [0047] results in a 3-d image for the interior of the eye.
For claim 17 see para. [0047] for an entire image or portion of an image of the irido-corneal angle circumference.
Claim(s) 8, 11 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Izatt et al. US 2014/0354951 as evidenced by Applicant Admitted Prior Art (AAPA) and Berlin US 20120283557.
For claims 8, 11, and 16, Izatt teaches that the scans may be a segmented into circumferential scans circumferential scan para. [0037], see fig. 4B, and between first and second azimuthal planar boundaries, which are the boundaries understood to be between the anterior chamber wall and the sclera where the irido-corneal angle components (i.e. trabecular meshwork and Schlemm’s canal) reside, which are those elements that are desired to be viewed for treating glaucoma. Para [0038]. Thus, when the segments are circumferential segments as in fig.4B, it is understood that the lower and upper azimuthal boundaries are the sclera and the anterior chamber rear wall at the Iris because those tissues that are positioned below and above these boundaries are of no interest and there would be no reason for scanning them. To provide illustration of the relationship of the components, see Applicant’s figure 2 Prior Art figure 2 for the areas of interest i.e. the Trabecular network 12 and Schlemm’s canal 18. Also, see figures 2 of Berlin US 20120283557. Berlin shows a detailed figure for anterior chamber 7 in the region of the anterior chamber for glaucoma scanning discussed in para. [0038] of Izatt. Berlin shows a perspective fragmentary view of the anatomy within the anterior chamber of an eye, depicting the corneoscleral angle in Fig. 2. Berlin shows that the anterior chamber is bounded by the cornea 15, the sclera 17, the iris 19, lens 4. Note that the trabecular meshwork 9 is partially located in the cornea 15 in front of the sclera cornea boundary as well as being located in the sclera below the cornea sclera boundary, The juxtacanalicular trabecular meshwork 13 and the Schlemm’s canal 11 are all positioned in the sclera (or in the cornea in front of the sclera boundary) above the iris. Thus, to visualize these structures the scanning is done from the anterior chamber boundary at the iris to a sclera boundary adjacent the cornea.
For claim 11, Izatt teaches that subsequent azimuthal slices para. [0037], fig. c para. [0048], have the same azimuthal boundaries as discussed in the preceding paragraphs for the glaucoma relevant structures but may start at the center of the cornea. Para. [0048].
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) 1, 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Izatt et al. US 2014/0354951 as evidenced by Applicant Admitted Prior Art (AAPA) in view of Yu US 2016/0008169 and further evidenced by Berlin US 2012/0282557 figures 1 and 2 which depict the components of the anterior chamber of the eye in greater detail.
Izatt et al teach a system for imaging and treating ocular tissues of an eye having a cornea ([0032]). Applicant’s figures 1-5 labeled as Prior Art includes anatomical structure of eye with an iris, an anterior chamber, and irido-corneal angle, and a direction of view. As such, any eye would necessarily include all of the anatomical features as disclosed in Prior Art figures 1-5 and [0005]-[0010] of the specification.
Izatt teaches a first optical subsystem (see contact lens GC of figure 1 or element 220 of fig 6.) configured to establish an optical path through the cornea of the eye, through the anterior chamber into the irido -corneal angle, wherein the optical path is offset from the optical axis within the direction of view. See figure 1 of Izatt wherein the light beam enters prism GC of the contact lens so as to be redirected at the exit surface CA of the contact lens and at an angle from the direction of view (along the axis of the cone shaped portion of the contact lens). A second optical system comprising an OCT imaging apparatus seen figure 2 or figure 6 (not including first optical system 220) to output an OCT beam, a scanning component an OCT beam, a scanning para.[0058] element 260 to collect images
Focusing optics (210) optically coupled between the scanning component and the first optical system (GC)
A control system (not shown) coupled with the second optical subsystem and configured to affect operation of the OCT imaging system
direct an OCT beam along the optical path,
align the OCT with the initial segment of ocular tissue of the irido-corneal angle,
Obtain an initial circumferential OCT image of the initial segment of ocular tissue and repeatedly align the OCT beam and obtain one or more addition segments of the ocular tissue. See para. [0035] for control of the system for repeatedly acquiring images along a circumferential path.
Applicant differs from Izatt in explicitly stating that the second optical subsystem is configured to rotate relative to the optical axis, whereas Izatt is silent to such a teaching. Yu teaches a similar OCT beam directing and scanning system in fig. 1 stored in an OCT scanning system (block 102) which performs the scanning functions of the second optical subsystem of the Izatt device, but additionally includes a surgical microscope viewing portion 108 for viewing the treatment area. The block (102) in figure 7 and its use discussed in accompanying para. [0047] is considered to be a second optical subsystem is designed to rotate about axis 128 which is aligned with the optical viewing axis such that the second optical system rotates (para. [0045]) about the axis of the first optical system which comprises contact lens 120 which corresponds to the optical view axis. It would have been obvious prior to the time of Applicants invention to have made the Izatt second optical subsystem rotatable about the optical axis in an arrangement like that of Yu “to provide flexibility to the observer 118, such as a surgeon, to move the optical block to a more convenient orientation during a surgical procedure” para. [0047].
For claim 13, claim 13 is similar to claim 1 but includes “directing the beam at a plurality of circumferential points” to acquire images, which points would correspond to the segments depicted in figure 4B of Izatt and to “construct a circumferential OCT image based on the obtained image data”. Which is taught in Para. [0035] of Izatt.
For claim 14, since Izatt is interested in viewing all of the components in the irido-corneal angle portion of the eye, which portion which extends from the base of the anterior chamber to the sclera, the circumferential scan would include images that extend from the recited boundaries.
Claim(s) 5-7, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Izatt et al. US 2014/0354951 as evidenced by Applicant Admitted Prior Art (AAPA) and in view of Yu US 2016/0008169.
For claims 5 and 18, Applicant differs from Izatt in explicitly stating that the second optical subsystem is rotated relative to the optical axis. Yu teaches a similar OCT beam directing and scanning system in fig. 1 stored in an OCT scanning system (block 102) which performs the scanning functions of the second optical subsystem of the Izatt device, but additionally includes a surgical microscope viewing portion 108 for viewing the treatment area. The block (element 102 in Figure 7) (second subsystem) is designed to rotate about axis 128 which is aligned with the optical viewing axis such that the second optical subsystem rotates about the axis of the first subsystem WFOV (contact) lens 120 which corresponds to the optical view axis. It would have been obvious prior to the time of Applicants invention to have made the Izatt second optical subsystem rotatable about the optical axis in an arrangement ”to provide flexibility to the observer 118, such as a surgeon, to move the optical block to a more convenient orientation during a surgical procedure” as taught by Yu in para. [0047].
For claims 6 and 19, in applying the modification of Izatt in view of Yu, as noted in the preceding paragraph, the rotation of the second optical system of Yu (block 102), does not result in the rotation of the first optical system i.e. the WFOV lens 120, which first optical system comprises an exit lens (120) coupled to the eye and having an axis aligned with the eye of Yu, and thus would be the same for Izatt as modified by Yu et al. The resulting system 100 would allow rotation of the second optical system (230) to be rotatable about the viewing axis without the first optical 220
For claim 7, it would be understood that in providing segmentation the target of the focus is one of limited possible selections, including at the mid-point of the boundaries of the desired segment scan, near the mid-point between the boundaries of the segment scan or away from the mid-point of the boundaries of the segment scan each providing expected results. Thus, choosing the target to be at the mid-point or near the mid-point would have been ab obvious choice from a limited number of choices above with no particular criticality expressed in the specification for choosing at or near the mid-point between the boundaries in Applicant’s specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK W. BOCKELMAN whose telephone number is (571)272-4941. The examiner can normally be reached Monday -Friday 8:00 am - 4:00 pm.
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/MARK W. BOCKELMAN/ Primary Examiner, Art Unit 3792
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