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 .
Response to Arguments
Applicant's arguments filed 2/25/2026 have been fully considered but they are not persuasive.
With respect to Katchinskiy and claims 1 and 12, applicant argues that division of dimensional localization responsibilities between a DMD confocal microscope and a separate OCT or SLO imaging system is not disclosed or suggested. Applicant further argues that a DMD confocal microscope generates images but does not specifically provide an xy-location of a target while a different imaging modality specifically provides a z-location of the target.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., distinct DMD confocal microscope, OCT, SLO systems) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Examiner acknowledges that Katchinskiy does not teach distinct DMD, OCT, and/or SLO devices that explicitly state said division of localization responsibilities but respectfully disagrees that this is a requirement of the claimed invention. Claim 1 recites a DMD confocal microscope configured to generate a first plurality of images; DMD confocal microscope further comprising a light source and micromirrors configured to direct, receive, and reject light; an image sensor configured to detect the imaging beam to generate the first plurality of images of the eye wherein these images provide an xy-location of the target; a laser device; an imaging system configured to generate a second plurality of images of the eye wherein these images provide a z-location of the target; and the imaging system comprises at least one of an OCT or SLO device.
Under broadest reasonable interpretation, claim 1 does not preclude a DMD confocal microscope from being the SLO device or a component of the SLO device. Furthermore, scanning laser ophthalmoscopy (SLO) is well known in the art as an imaging technique based on confocal laser scanning microscopy that provides high-resolution lateral 2D images of the eye. Katchinsky teaches 2D SLO images of the eye [0003]. The DMD device is a component of the confocal SLO system [0113] and determines the lateral or xy-location of the target because the SLO system inherently has limited depth resolution.
Optical coherence tomography (OCT) is well known in the art as an imaging technique that utilizes low-coherence light to capture cross-sectional images of the eye at various depths. Katchinsky teaches 3D OCT cross-section images of the eye [0003]. Cross-sectional images relative to lateral xy-images of the eye inherently produce z-locations of the target.
In addition, applicant argues that Katchinsky does not disclose a computer configured to determine an xyz-location by combining an xy-location extracted from DMD confocal microscope images and a z-location extracted from OCT or SLO images. Applicant further argues that image registration between modalities is not equivalent to the claimed dimensional recombination. Examiner acknowledges that Katchinskiy does not explicitly disclose a computer configured to determine an xyz-location from the respective xy and z determinations and image registration is a means for validation but respectfully disagrees that a computer is not configured to determine an xyz-location from SLO and OCT images and that image registration is not equivalent to the claimed dimensional recombination.
Under broadest reasonable interpretation, the xy-location is extracted from confocal SLO images with MEMs (DMD) components and the z-location is extracted from OCT images. Katchinsky teaches a computing device (114, Fig. 2-4) that controls operation of the imaging and laser delivery systems along with data acquisition from SLO, OCT, and treatment laser devices ([0064], [0068], Fig. 2-4). Treatment laser targeting necessitates positional data derived from said SLO (104, Fig. 1) and OCT (106, Fig. 1) components. Furthermore, although the intended use of image registration disclosed by Katchinskiy is not the same as the claimed invention, the results are equivalent whereby an xyz-location of a target is determined from image registration of a plurality of first and second images. The Federal Circuit does not distinguish between structurally different or means-plus-function elements that perform equivalent functions unless limited to certain specific structural or additional functional characteristics. See, e.g., Ishida Co. v. Taylor, 221 F.3d 1310, 55 USPQ2d 1449 (Fed. Cir. 2000) (The court construed the scope of a means-plus-function claim element where the specification disclosed two structurally very different embodiments for performing the claimed function by looking separately to each embodiment to determine corresponding structures. The court declined to adopt a single claim construction encompassing both embodiments since it would be so broad as to describe systems both with and without the fundamental structural features of each embodiment.)
With respect to Brennan, applicant asserts that Brennan does not remedy the deficiencies of Katchinsky for at least the reasons provided for claim 1.
With respect to Gonzalez, applicant asserts that Gonzalez does not cure the deficiencies of Katchinsky and Brennan because Gonzalez does not disclose generating multimodal images, a DMD confocal microscope providing an xy-location and a separate OCT or SLO imaging system providing a z-location, or determining a target’s xyz-location from image derived data extracted from said multimodal images. Therefore, in view of Katchinskiy, the rejection regarding claims 1 and 12 is maintained.
With respect to Katchinsky, Brennan, Gonzalez, and claim 27, applicant argues that allocation of dimensional localization responsibilities and combining modality-specific coordinate components into an xyz-location derived from separate pluralities of images are not disclosed by the prior art.
With respect to Katchinskiy, applicant further argues that an SLO device that is used specifically to determine the z-location of a target while a DMD confocal microscope provides the xy-location is not disclosed. Examiner acknowledges that an SLO device that is specifically used to determine the z-location of a target is not disclosed but respectfully disagrees that this is a requirement of the claimed invention. Claim 27 recites a second imaging system configured to generate a second plurality of images of the eye; the second plurality of images of the eye provide a z-location of the target; the second imaging system comprises an SLO device.
Katchinskiy discloses a system comprising an SLO device and an OCT device. Claim 27 does not limit the SLO device to generate a second plurality of images and the second imaging system is configured to generate a second plurality of images. Claim 27 only requires that the second imaging system comprises an SLO device. Furthermore, the Federal Circuit does not distinguish between structurally different or means-plus-function elements that perform equivalent functions unless limited to certain specific structural or additional functional characteristics. See, e.g., Ishida Co. v. Taylor, 221 F.3d 1310, 55 USPQ2d 1449 (Fed. Cir. 2000) (The court construed the scope of a means-plus-function claim element where the specification disclosed two structurally very different embodiments for performing the claimed function by looking separately to each embodiment to determine corresponding structures. The court declined to adopt a single claim construction encompassing both embodiments since it would be so broad as to describe systems both with and without the fundamental structural features of each embodiment.)
With respect to Gonzalez and Brennan, applicant argues that Gonzalez and Brennan do not address the deficiencies set forth by Katchinskiy. Therefore, in view of Kachinskiy, the rejection regarding claim 27 is maintained.
With respect to dependent claims 2-6, 11, 13-17, and 22-26, applicant argues that the remaining cited art does not cure the deficiencies of Katchinskiy, Brennan, and Gonzalez. Therefore, in view of Katchinskiy, rejections regarding claims 2-6, 11, 13-17, and 22-26 are maintained.
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) 1,11,12,22,25,26, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katchinskiy et al (International Publication WO2022077117 A1); hereinafter Katchinskiy, Brennan et al (US Pre Grant Publication 20110282331 A1); hereinafter Brennan, and Gonzalez et al (US Pre Grant Publication 20210244565 A1); hereinafter Gonzalez.
Regarding claim 1, 12, and 27, Katchinskiy teaches an ophthalmic laser surgical system ([0006] device for treatment of eye condition) for imaging and treating a target in an eye ([0006] imaging and laser delivery), comprising:
a digital micromirror device (DMD) confocal microscope ([0064] the scanning optics could be provided by MEM mirrors, or other devices such as micromirror devices) configured to generate a plurality of images of the eye ([0032] images), an axis of the eye defining a z-axis ([0064] moving along z axis…towards or away from the eye), the z-axis defining a plurality of xy- planes ([0064] XY scanning optics), the DMD confocal microscope comprising:
a light source configured to provide a microscope imaging beam ([0008] SLO light source, OCT light source, external light source);
a DMD device comprising an array of micromirrors ([0064] micromirror devices) configured to:
direct the microscope imaging beam along an imaging path towards the eye ([0064] SLO optical path includes elements to deliver the light from the source to the eye);
receive the microscope imaging beam reflected from the eye ([0064] direct the returning light from the eye to the SLO detector); and
reject light of the microscope imaging beam reflected from the eye that is not from an image plane to scan the microscope imaging beam ([0083] filters to block wavelengths, apertures to block unfocused light); and
an image sensor configured to detect the scanned microscope imaging beam to generate the first plurality of images of the eye, the first plurality of images of the eye providing an xy-location of the target ([0064] SLO detector);
a laser device configured to direct a laser beam along a laser beam path towards the target in the eye ([0084] delivering laser treatment to targeted location in the eye); and
a computer configured to send instructions to the DMD confocal microscope ([0065] computer 114) and the laser device ([0127] computer also drives the laser);
an imaging system configured to generate a second plurality of images of the eye (Under normal operation and use of the device disclosed by Katchinskiy, it can be reasonably expected that it will be used to capture multiple pluralities of images over the lifecycle of the device. There is no limitation in Katchinskiy that states that the system is single use and no specific timeframe that the second plurality of images must be captured is present in this application), wherein:
Katchinskiy teaches an imaging system configured to determine a z-location of the target relative to the z-axis ([0120] accurate targeting along the x, y, and z axes).
the imaging system comprising a scanning laser ophthalmoscope (SLO) device ([0006] a scanning laser ophthalmoscopy (SLO) optical pathway for SLO imaging)
Katchinskiy fails to teach the light source comprises a white light source. Brennan teaches the light source comprising a white light source ([0070]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Katchinskiy with Brennan because there is some teaching, suggestion, or motivation to do so. Brennan teaches that using white light provides sufficient intensity ([0070]).
While Katchinskiy teaches using both a DMD micromirror device and an SLO or OCT device and that they can be used in conjunction, it doesn't explicitly teach that the DMD device is used to determine the xy plane position (first plurality of images) and the SLO or OCT device is used to determine the z axis position (second plurality of images). However, Katchinsky implies that the DMD micromirror device (304, Fig. 3) derives x-y plane positions (first plurality of images) ([0064], Fig. 3; 2D MEMS mirror) and OCT cross-sectional images derive z-axis positions (second plurality of images) ([0003], Fig. 2; SLO 2D; OCT 3D and/or cross-sectional).
Gonzales teaches "the scanning assembly 18 can include a Z-scan device and an xy-scan device. The laser surgery system 10 may be configured to focus the electromagnetic radiation beam 28 to a focal point that is scanned in three dimensions" ([0023]) and “for example, the XY-scan device 60 can include one or more mirrors" ([0026]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Katchinskiy and Brennan with Gonzalez because “the combination of the z-scan device 58 and the xy-scan device 60 can be operated to controllably scan the focal point in three dimensions, for example, within the eye of the patient” ([0026]).
Regarding claims 11 and 22, the combination of Katchinskiy, Brennan, and Gonzalez teaches the system of claim 1 and 12. Katchinskiy teaches an xy-scanner ( [0011] XY scanning optics) configured to:
receive an imaging beam from the imaging system ([0006] optical pathway for SLO) and direct the imaging beam along an imaging system beam path towards the eye (fig 1, arrow between 102 (specifically 104 and 106) and 112 indicates towards the eye); and
receive the laser beam from the laser device ([0006] treatment optical pathway) and direct the laser beam along the laser beam path aligned with the imaging system beam path towards the eye (fig 1, arrow between 102 (specifically 108) and 112 indicates towards the eye).
Katchinskiy teaches an xy-scanner ( [0011] XY scanning optics) configured to:
receive an imaging beam from the imaging system ([0006] optical pathway for SLO) and direct the imaging beam along an imaging system beam path towards the eye (fig 1, arrow between 102 (specifically 104 and 106) and 112 indicates towards the eye); and
receive the laser beam from the laser device ([0006] treatment optical pathway) and direct the laser beam along the laser beam path aligned with the imaging system beam path towards the eye (fig 1, arrow between 102 (specifically 108) and 112 indicates towards the eye).
Regarding claims 25 and 26, the combination of Katchinskiy, Brennan, and Gonzalez teaches the system of claim 1 and method of claim 12. Gonzalez further teaches the DMD confocal microscope and the imaging system are configured to generate the first and second plurality of images synchronously in real-time ([0025] This information is then loaded into the control electronics 70, and used to program and control the subsequent laser-assisted surgical procedure - if the data from the scanning is used for determining moment-to-moment where to point the laser, it has to be simultaneously doing the xy and z).
Claim(s) 2 and 13 is/are rejected under 35 USC 103 as being unpatentable over Katchinskiy, Brennan, and Gonzalez in view of Schuele et al (US Pre Grant Publication 20170326003 A1); hereinafter Schuele.
Katchinskiy, Brennan, and Gonzalez teach the system of claim 1 and the method of claim 12. However, the combination fails to teach that the target is a vitreous eye floater. Schuele teaches that the target is a vitreous eye floater ([0005] vitreous bodies or floaters).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Katchinskiy with the teachings of Schuele because doing so would constitute substitution of one known element for another to obtain predictable results. Both Katchinskiy and Schuele teach a system for ophthalmic imaging and subsequent use of a laser to treat a particular target in the eye identified by the imaging system. Substituting the generic target of Katchinskiy for the specific target of a floater in Schuele because would be predictable that the system of Katchinskiy can treat the specific target of a floater.
Claim(s) 3-6 and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katchinskiy, Brennan, and Gonzalez further in view of Schallek et al (US Pre Grant Publication 20180338679 A1); hereinafter Schallek.
Regarding claims 3 and 14, Katchinskiy, Brennan, and Gonzalez fail to teach a DMD device that operates as a pinhole to reject light that is not from the image plane. Schallek teaches a DMD device configured to reject light of the microscope imaging beam reflected from the eye that is not from the image plane to scan the microscope imaging beam ([0079] reject light from the surround) by:
toggling on a set of one or more micromirrors ([0079] DMD detection arm, rapid and precise alignment) that operate as a pinhole ([0079]artificial pinhole) to scan the microscope imaging beam (light distribution pattern).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Katchinskiy/Brennan with the teachings of Schallek because there is some teaching, suggestion, or motivation to do so. Katchinskiy already discloses an aperture that can be used for rejecting other light ([0083]). Schallek teaches that this kind aperture or pinhole require precise mechanical stages to control and this mechanical constraint makes rapid alignment slow and prone to error ([0083]) and using an artificial pinhole with a DMD would resolve that problem. Therefore, it would have been obvious to replace the aperture of Katchinskiy with the DMD based artificial pinhole of Schallek.
Regarding claims 4 and 15, the combination of Katchinskiy, Brennan, Gonzalez, and Schallek teaches the DMD device configured to reject light of the microscope imaging beam reflected from the eye that is not from the image plane to scan the microscope imaging beam by:
toggling on a set of one or more micromirrors that operate as a plurality of pinholes to scan the microscope imaging beam.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Katchinskiy/Brennan with the teachings of Schallek because there is some teaching, suggestion, or motivation to do so. Katchinskiy already discloses an aperture that can be used for rejecting other light ([0083]). Schallek teaches that this kind aperture or pinhole require precise mechanical stages to control and this mechanical constraint makes rapid alignment slow and prone to error ([0083]) and using an artificial pinhole with a DMD would resolve that problem. Therefore, it would have been obvious to replace the aperture of Katchinskiy with the DMD based artificial pinhole of Schallek.
While the combination of Katchinskiy and Schallek does not explicitly state a plurality of pinholes, it would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify either reference individually or in combination to duplicate the pinhole disclosed in claims 3 and 14, because mere duplication of parts is not patentably significant.
Regarding claims 5 and 16, the combination fails to teach generating a plurality of 2D enface images at a plurality of xy-planes. Schallek teaches the DMD confocal microscope configured to:
generate a plurality (images is plural) of two-dimensional (2D) enface images ([0059] OCT images) at the plurality of xy-planes ([0054] plurality of axial focus depths).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Katchinskiy with the teachings of Schallek because there is some teaching, suggestion or motivation to do so. Schallek states that constructing a 3D image can provide information beyond the traditional approach and that advantages over the prior include an enhancement of contrast from translucent objects ([0054]).
Regarding claims 6 and 17, Schallek further teaches the DMD confocal microscope configured to:
combine the plurality of two-dimensional (2D) enface images to generate a three- dimensional (3D) image ([0054] combining information about the axial focus depths and the lateral point-spread of light provides 3D information).
Claim(s) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katchinskiy, Brennan, Gonzalez, and Schuele in view of Lin et al (US Pre Grant Publication 20160227999 A1); hereinafter Lin.
The combination of Katchinskiy, Brennan, Gonzalez, and Schuele teaches the system of claim 2 and the method of claim 13. The combination fails to teach that the xy location is based on the shadow of the floater. Lin teaches the xy-location of the target is based on a shadow of the vitreous eye floater ([0036] linear scale OCT data may enhance the ability to detect shadows in the structural OCT data.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Katchinskiy and Brennan with Lin because there is some teaching, suggestion, or motivation to do so. Lin teaches that shadowing effects from opacities in the path of light (e.g. floaters in the vitreous or cataracts), can complicate the interpretation of OCT angiography images in assessing non-perfusion ([0035]). Therefore, imaging using the shadows can help identifying the floaters.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWANE COLLARD whose telephone number is (571)272-6553. The examiner can normally be reached M-F 9 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ben Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWANE COLLARD/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792