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
1. Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive. The Applicant argues that the art of Heeren does not teach the optical elements coupling to the laser system and the imaging system. The Examiner respectfully disagrees. Looking at Fig 2 and Par. 0030 and 0038, the imaging system [210] comprises optical elements such as a focusing means which is then coupled to the controller [220] for controlling this optical means, which is then coupled to the laser system [212] for emitting the focused laser. Next the Applicant argues that the image taken in Heeren is not live and that there is no indication that images are even provided, especially images with markings. The Examiner points to Par. 0028 which talks about the steps taken during the procedure, including how “The U/I 240 may also include a display for rendering image(s) of the eye or providing other visual feedback to the physician”. This indicates that this is done live seeing as the images are provided to the user for visual feedback during the procedure. Regarding the markings, while Par. 0032 indicates “The images 300 may or may not be rendered and shown to the physician via the U/I”, this does not mean that the marked images are not being shown. In fact, this indicates that the system is capable of showing these marked images to the physician during the surgery. Par. 0034 even goes into detail about how the keep out zones, i.e. markings, are determined based on the images and can be modified by the physician on the image before performing the surgery. Therefore, the rejection still stands.
New claim 43 contains the allowable subject matter from claim 27, and is therefore allowable.
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.
2. Claim(s) 22-26, 29-30, 32-38, and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heeren (US 20180028354 A1) in view of Woodley (US 20140114297 A1).
In regards to claim 22, Heeren discloses an arrangement for laser treatment of eye opacification (Par. 0003), comprising:
a measuring system (Par. 0017 teaches the use of an OCT ; Applicant states on page 9 of their specification that the measuring system can be an OCT);
a laser system with optical elements the laser system (Fig 2 and Par. 0023 teach the use of a laser and Par. 0002 and 0038 teach focusing means, i.e. optical elements);
an eye tracker unit (Par. 0040 teaches a tracking means);
a display unit (Par. 0028 teaches a display unit); and
a control and operating unit (Fig 2, element 220);
wherein the laser system is configured to comminute eye opacifications (Par. 0006 teaches the laser removes the opacites; i.e. comminutes);
wherein the display unit is configured to display at least one 2-D image representation of the eye as a live image (Par. 0028 teaches the display giving feedback images of the eye during the procedure);
wherein the control and operating unit is configured to to determine at least one exclusion zone for laser treatment, the exclusion zone including at least one of a retina and a capsular bag (Par. 0018-0019 teaches the device determining keep out zones where the laser is not applied, such zones including the retina), and
wherein the control and operating unit is further configured to generate at least one marking that marks each of the at least one exclusion zones and marks the laser focus, and configured to display the markings on the display unit and to overlay the markings on the live image (Par. 0034 discloses that the keep out regions are determined based on the imaging data received and that they can be identified using dashed lines, i.e. marks).
While Heeren teaches a measuring OCT device and a tracking device, they do not explicitly teach that the OCT can measure and make available depth information relating to eye structures in the form of depth profiles or wherein the eye tracker unit is configured to detect axial eye movements.
However, in the same field of endeavor, Woodley teaches a laser system for treating opacifications of the eye (Abstract and Par. 0002) wherein an OCT imaging device is used to determine depth information (Par. 0036 and 0054) and wherein an eye tracker is sued to measure eye movement (Par. 0055) in order to generate accurate eye images and define the cutting patterns used in the surgical procedure (Par. 0090).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Heeren to explicitly teach that the OCT can measure and make available depth information relating to eye structures in the form of depth profiles or wherein the eye tracker unit is configured to detect axial eye movements, as taught and suggested by Woodley, in order to generate accurate eye images and define the cutting patterns used in the surgical procedure (Par. 0090 of Woodley).
In regards to claim 23, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 22, wherein the control and operating unit is configured to determine the depth of the eye opacification relative to the depth of the laser focus and to generate markers for the relative position of eye opacification in relation to the laser focus
and to display these markings on the display unit (Par. 0036 of Woodley teaches that incision parameters like depth are shown on a display unit and Fig 33 of Woodley also shows you can view depth of incisions and target areas, i.e. opacites)
In regards to claim 24, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 23, wherein the control and operating unit is configured to vary characteristics of the marking to be generated with regard to at least one of color, shape, numerical value of the depth and size (Par. 0034 of Heeren discloses that the keep out regions are identified using dashed lines/marks; these marks would be based on the size of the zone).
In regards to claim 25, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 22, wherein the control and operating unit is configured to generate the markings with depth-dependent size for the retina, the capsular bag, a lens, the laser focus or the eye opacification in such a way that the markings are arranged, centered around the lateral laser focus position (Fig 4D-L of Heeren).
In regards to claim 26, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 22, wherein the eye tracker unit is configured to compensate for axial eye movements (Par. 0055 of Woodley).
In regards to claim 29, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 22, wherein anterior regions of the eye, selected from a group consisting of the capsular bag, a lens, a front surface of the cornea or back surface of the cornea, serve as a reference for the eye tracker unit (Par. 0002-0003 of Heeren teach the lens and cornea containing opacities are focused on and Par. 0040 of Heeren teaches the eye tracker uses the opacity as the reference).
In regards to claim 30, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 22, wherein a contact glass or a reference marking placed in the vitreous humor by laser treatment serves as a reference for the eye tracker unit (Par. 0040 of Heeren teaches using the vitreous opacity (which is marked) as reference for the tracker)
In regards to claim 32, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 22, further comprising an OCT system configured to record a 3-D volume scan and wherein the eye tracker unit is configured to compensate for eye movements detected during the recording of the 3-D volume scan (Par. 0032 of Heeren).
In regards to claim 33, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 22, wherein the display unit is configured to display further image representations, including the scan with the depth information of the eye, an overview of current settings, operating elements or a combination of the foregoing (Fig 12-40 of Woodley).
In regards to claim 34, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 22, wherein the display unit comprises a touch screen (Par. 0041 of Woodley)
In regards to claim 35, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 22, wherein the control and operating unit is configured to display on the display unit the markings generated for the exclusion zones of the retina and capsular bag and for the laser focus and to overlay these on the scan Par. 0034 discloses that the keep out regions are determined based on the imaging data received and that they can be identified and displayed using dashed lines, i.e. marks
In regards to claim 36, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 22, wherein the control and operating unit is configured to localize retinal landmarks, including at least one of a fovea, a macula, an optic nerve head and blood vessels, and to generate a marking for the retinal landmarks (Par. 0018-0019 of Heeren)
In regards to claims 37 and 38, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 23, wherein the markings generated by the control and operating unit differ in terms of color, structure or both (Par. 0034 of Heeren teaches the markings can be dashed or dotted).
In regards to claim 42, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 22, wherein the arrangement for laser treatment of eye opacification is integrated into a slit lamp (Par. 0003 of Heeren).
3. Claim(s) 28 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heeren and Woodley, and in further view of Potgieter (US 20020082590 A1).
In regards to claim 28 and 31, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 22, except for wherein the measuring system for obtaining depth information of the eye comprises an OCDR system, further comprising an OCDR system configured to record an A-scan and further comprising an image recording unit for making recordings of the fundus, with a position of the OCDR measuring beam in relation to the fundus being known through calibration.
However, in the same field of endeavor, Potgieter teaches a eye tracking system for laser surgery of the eye (Abstract), wherein an OCR system is used (Par. 0011 and 0014) and A-scans are obtained in order to allow for image processing means to be employed to identify the pattern in the image of the eye.
Therefore, it would have been obvious to one having ordinary skill in the art to have taken the teachings of Heeren and Woodley and modified them by having the system comprise an OCR system, as taught and suggested by Potgieter, in order to allow for image processing means to be employed to identify the pattern in the image of the eye (Par. 0014 of Potgieter).
4. Claim(s) 28 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heeren and Woodley, and in further view of Martin (US 7001018 B1).
In regards to claim 39, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 22, except for wherein the control and operating unit is configured to warn the operator acoustically, optically or both when the laser focus approaches one of the exclusion zones or retinal landmarks.
However, in the same field of endeavor, Martin discloses a laser surgical system (Abstract) wherein the system can send an alert to the user if the laser is not in a treatment zone (Col 5, lines 55-67) in order to only treat the desired area and not harm any surrounding tissue.
Therefore, it would have been obvious to one having ordinary skill in the art to have taken the teachings of Heeren and Woodley and modified them by having the system alert the user if the laser is outside of the treatment zone, as taught and suggested by Martin, in order to only treat the desired area and not harm any surrounding tissue.
5 Claim(s) 40 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heeren and Woodley, and in further view of Pawlowski (US 20040002694 A1).
In regards to claim 40 and 41, the combined teachings of Heeren and Woodley disclose the arrangement as claimed in claim 22, wherein the control and operating unit is configured to switch off the laser system should the laser focus approach or enter one of the exclusion zones or retinal landmarks and wherein the control and operating unit is configured to assign different tolerances for switching off the laser system when the laser focus is approaching the two exclusion zones and the retinal landmarks.
However, in the same field of endeavor, Pawlowski discloses an eye treatment system (Abstract) wherein the beam source can be automatically switch off if it is outside of the treatment area (Par. 0063) in order to have an added safety feature to the system.
Therefore, it would have been obvious to one having ordinary skill in the art to have taken the teachings of Heeren and Woodley and modified them by having the system automatically switch the laser beam off, as taught and suggested by Pawlowski, in order to have an added safety feature to the system.
Allowable Subject Matter
6. Claims 27 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim 43 is allowable. Both claims contain subject matter that is not found in the art, such subject matter includes “a refresh rate selected from a group consisting of 5 Hz, 10 Hz, and 20 Hz, and a latency selected from a group consisting of <200 ms, <100 ms and <35 ms”. While relevant art teaches having a refresh rate/latency (see US 20130158531 A1), they do not teach these rates.
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 SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached Monday-Friday, 7:30-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.L.C./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792