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 .
Remarks
This action is in response to the remarks filed 07/09/2026.
Claims 15, 16, 18-26, 28-38, and 40-46 are pending.
Response to Arguments
Applicant’s arguments, see page 9, filed 07/09/2026, with respect to the rejection of claims 15, 16, 18-26, 28-38, and 40-46 under 35 U.S.C. 112(a) have been fully considered and are persuasive. Claims 15, 25, and 37 have been amended to include language from the specification that overcomes the rejection. Therefore, the rejection of claims 15, 16, 18-26, 28-38, and 40-46 under 35 U.S.C. 112(a) has been withdrawn.
While the claims were indicated as having no prior art rejections in the office action of 01/14/2026, after further search and consideration, the claims are now rejected under 35 U.S.C. 103 as explained in the office action below.
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.
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.
Claims 15, 16, 19, 20, 24-26, 29, 30, 34, 36-38, 41, 42, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Gertner et al. (US Patent Application Publication 2009/0163898 – APPLICANT CITED ON 12/04/2020 IDS, of record), hereinafter Gertner, in view of Maeda et al. (US Patent Application Publication 2004/0143246 - APPLICANT CITED ON 12/04/2020 IDS, of record), hereinafter Maeda, further in view of Bor (US Patent Application Publication 2014/0155873, of record), and further in view of Gertner et al. (International Application Publication WO 2008/150330), hereinafter Gernter’330.
Regarding claims 15, 25, and 37, Gertner discloses a method, treatment apparatus, and non-transitory computer readable medium for determining a current position of a patient interface of an eye surgical laser of a treatment apparatus for an eye of a patient relative to an optical axis, wherein the patient interface is configured to be docked to the eye of the patient (e.g. Abstract; Par. [0031]; Par. [0130]; Par. [0166]: the contact member 420, which is considered to be the patient interface, contacts the eye of the patient; Pars. [0137]-[0138]: using the laser axis 311 to determine position), comprising the steps of:
determining a target position of the patient interface relative to the optical axis (e.g. Pars. [0131]-[0132]: aligning the treatment device to the determined target tissue; Par. [0171]: positioning device 400 with contact member 420 on the eye);
positioning the patient interface in a preset area in front of the optical axis (e.g. Par. [0132]; Fig. 3B: placing the treatment device in line with axis 18; Par. [0125]: determining that the device is at the correct location; Par. [0166]: the contact member 420 contacts the eye of the patient; Par. [0171]: positioning the device on the eye; Figs. 4A-B: positioning contact member 420 on the eye in a preset area);
illuminating the patient interface by means of an illumination device of the treatment apparatus (e.g. Par. [0112]: light is provided through light source 108; Fig. 4B: light source 108 illuminating contact member 420);
capturing a Purkinje image associated with the patient interface by means of an optical capturing device of the treatment apparatus (e.g. Par. [0109]: capturing Purkinje reflex by using corneal covering; Par. [0112]: capturing Purkinje image with image capture system 102; Fig. 4B: image capture system 102 used to capture image with contact member 420; Par. [0168]: taking images of the limbus while in contact with patient interface); and
comparing a captured Purkinje image to the optical axis and determining the current position of the patient interface depending thereon (e.g. Par. [0112]: “an image capture system 102 for generating an alignment along the geometric axis 18 from information captured at two distinct but interrelated locations in a subject's eye 10.”; Par. [0171]: determining position and orientation of the ocular contact device).
Gertner further discloses positioning the device using a reference axis (e.g. Par. [0155]; Par. [0166]), but does not specifically disclose the optical axis describing a position of a laser beam in a neutral pose of a beam deflection device of the treatment apparatus, capturing a Purkinje image associated with the patient interface by means of an optical capturing device of the treatment apparatus, comparing the current position to the target position and with a deviation of the current position from the target position, outputting a control signal to a control device of the treatment apparatus, and determining a decentration, but also a tilt, of the patient interface in relation to the optical axis.
Maeda, in a similar field of endeavor, is directed towards a corneal surgery apparatus. Maeda discloses comparing the current position to a target position, and with a deviation of the current position from the target position, outputting a control signal to a control device of the treatment apparatus (e.g. Pars. [0069]-[0070]: comparing deviation in order to move the laser beam to correct the difference).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gertner to include comparing the current position to the target position and with a deviation of the current position from the target position, outputting a control signal to a control device of the treatment apparatus as taught by Maeda, because doing so would improve accuracy in providing therapy at the desired location.
However, Gertner in view of Maeda fails to disclose the optical axis describing a position of a laser beam in a neutral pose of a beam deflection device of the treatment apparatus, capturing a Purkinje image associated with the patient interface by means of an optical capturing device of the treatment apparatus, and determining a decentration, but also a tilt, of the patient interface in relation to the optical axis.
Bor, in a similar field of endeavor, is directed towards treating a patient with a laser beam and a patient interface lens. Bor discloses the optical axis describing a position of a laser beam in a neutral pose of a beam deflection device of the treatment apparatus (e.g. Par. [0008]: lining up laser axis to the treatment axis; Par. [0047]: laser axis 123; Par. [0066]), and determining a decentration and a tilt of the patient interface in relation to the optical axis (e.g. Par. [0084]: table 1, steps 905, 910, 930, 940, and 950, attaching patient interface to the loading dock, determining position of the patient interface, determining tilt angle, decentration correction vector; Par. [0090]: determining tilt angle; Pars. [0092]-[0093]: determining decentration correction vector) in order to decrease alignment error between the patient interface and the treatment area (e.g. Par. [0080]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gertner in view of Maeda to include the laser axis and determining decentration and tilt of Bor, because doing so would decrease alignment error between the patient interface and the treatment area (e.g. Bor, par. [0080]).
However, Gertner in view of Maeda and Bor fails to specifically disclose capturing a Purkinje image associated with the patient interface by means of an optical capturing device of the treatment apparatus. Gertner’330, in a similar field of endeavor, is directed towards a device for positioning, stabilizing, and treating an eye of a patient. Gertner’330 discloses capturing a Purkinje image associated with the patient interface by means of an optical capturing device of the treatment apparatus to align the eye with the attached contact member (e.g. page 38, lines 14-21).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gertner in view of Maeda and Bor to include capturing a Purkinje image associated with the patient interface as taught by Gertner’330, because doing so would provide guidance to the user to align the eye with the attached contact member (e.g. Gertner’330, page 38, lines 14-21).
Claims 15, 25, and 37 are obvious over Gertner, Maeda, Bor, and Gertner’330 as indicated above. Regarding claims 16, 26, and 38, Gertner further discloses wherein a first order or second order Purkinje reflex is captured as the Purkinje image (e.g. Pars. [0108]-[0109]).
Claims 15, 25, and 37 are obvious over Gertner, Maeda, Bor, and Gertner’330 as indicated above. Regarding claims 19, 29, and 41, Gertner further discloses wherein said patient interface is illuminated by means of an illumination ring or illumination point or by means of an illumination half ring or by means of illumination sectors of the illumination device for generating the Purkinje image (e.g. Par. [0114]: light sources used to direct light to the eye surface).
Claims 15, 25, and 37 are obvious over Gertner, Maeda, Bor, and Gertner’330 as indicated above. Regarding claims 20, 30, and 42, Gertner further discloses wherein said patient interface is illuminated with infrared light by means of an infrared illumination device and the optical capturing device is configured such that infrared light reflected on the patient interface at least in certain areas is captured (e.g. Par. [0209]: infrared light is used to capture images).
Claims 15, 25, and 37 are obvious over Gertner, Maeda, Bor, and Gertner’330 as indicated above. Regarding claims 24, 34, and 46, Gertner further discloses wherein the Purkinje image is captured by means of an optical capturing device arranged at the patient interface (e.g. Pars. [0111]-[0112]: Purkinje image is captured by camera 102; Par. [0114]; Fig. 4B: image capture system 102 used to capture image with contact member 420; Par. [0168]).
Claim 25 is obvious over Gertner, Maeda, Bor, and Gertner’330 as indicated above. Regarding claim 36, Gertner further discloses a computer program including commands that cause the treatment apparatus according to claim 25 to execute the method steps described therein (e.g. Par. [0134]: computer with programming).
Claims 18, 21-23, 28, 31-33, 35, 40, and 43-45 are rejected under 35 U.S.C. 103 as being unpatentable over Gertner et al. (US Patent Application Publication 2009/0163898 – APPLICANT CITED ON 12/04/2020 IDS, of record), hereinafter Gertner, in view of Maeda et al. (US Patent Application Publication 2004/0143246 - APPLICANT CITED ON 12/04/2020 IDS, of record), hereinafter Maeda, further in view of Bor (US Patent Application Publication 2014/0155873, of record), and further in view of Gertner et al. (International Application Publication WO 2008/150330), hereinafter Gernter’330, as applied to claims 15, 25, and 37 above, and further in view of Yee (US Patent Application Publication 2007/0219543, of record).
Claims 15, 25, and 37 are obvious over Gertner, Maeda, Bor, and Gertner’330 as indicated above. Regarding claims 18, 28, and 40, Gertner fails to disclose wherein after an ascertained deviation below a preset deviation threshold value, a control signal is generated such that a docking procedure of the patient interface to the eye is performed. Yee, in a similar field of endeavor, is directed towards intrastromal refractive correction systems and methods. Yee discloses wherein after an ascertained deviation below a preset deviation threshold value, a control signal is generated such that a docking procedure of the patient interface to the eye is performed (e.g. Par. [0062]: the patient interface only engages with the eye when the alignment is below a threshold).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gertner in view of Maeda, Bor, and Gertner’330 to include a control signal being generated after an ascertained deviation is below a preset threshold value as taught by Yee, because doing so would provide improved engagement between the patient interface and the eye.
Claims 15, 25, and 37 are obvious over Gertner, Maeda, Bor, and Gertner’330 as indicated above. Regarding claims 21, 31, and 43, Gertner fails to disclose wherein the patient interface is configured electrically insulated and/or sterile. Yee, in a similar field of endeavor, is directed towards intrastromal refractive correction systems and methods. Yee discloses it is known for a patient interface to be sterile (e.g. Par. [0076]: confirming the device with patient interface 104 has not been used in a prior procedure in order to avoid sterilization issues).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gertner in view of Maeda, Bor, and Gertner’330 to include the patient interface being sterile as taught by Yee, because doing so would ensure there are no contamination or sterilization issues.
Claims 15, 25, and 37 are obvious over Gertner, Maeda, Bor, and Gertner’330 as indicated above. Regarding claims 22, 32, and 44, Gertner fails to disclose wherein with a deviation above a preset deviation threshold value, the patient interface is newly positioned as the control signal. Yee, in a similar field of endeavor, is directed towards intrastromal refractive correction systems and methods. Yee discloses wherein with a deviation above a preset deviation threshold value, the patient interface is newly positioned as the control signal (e.g. Par. [0063]: when the engagement between the patient interface and eye tissue is above a threshold, the alignment process continues until the desired threshold is met, the thresholds are then established to allow sufficient adjustment).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gertner in view of Maeda, Bor, and Gertner’330 to include wherein with a deviation above a preset deviation threshold value, the patient interface is newly positioned as the control signal as taught by Yee, because doing so would provide improved engagement between the patient interface and the eye.
Claims 15, 25, and 37 are obvious over Gertner, Maeda, Bor, and Gertner’330 as indicated above. Regarding claims 23, 33, and 45, Gertner fails to disclose wherein with a deviation above a preset deviation threshold value, a position variation of the eye surgical laser, in particular of the laser beam, is performed. Yee, in a similar field of endeavor, is directed towards intrastromal refractive correction systems and methods. Yee discloses wherein with a deviation above a preset deviation threshold value, a position variation of the eye surgical laser, in particular of the laser beam, is performed (e.g. Par. [0063]: when the engagement between the patient interface and eye tissue is above a threshold, the alignment process continues until the desired threshold is met).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gertner in view of Maeda, Bor, and Gertner’330 to include wherein with a deviation above a preset deviation threshold value, a position variation of the eye surgical laser, in particular of the laser beam, is performed as taught by Yee, because doing so would provide improved engagement between the patient interface and the eye.
Claim 25 is obvious over Gertner, Maeda, Bor, and Gertner’330 as indicated above. Regarding claim 35, Gertner further discloses at least one beam deflection device for beam guidance and/or beam shaping and/or beam deflection and/or beam focusing of a laser beam of the laser (e.g. Par. [0114]: mirrors (beam deflection device) used for guiding light; Par. [0153]: mirror used to direct therapeutic beam 311). However, Gertner fails to disclose wherein the control device comprises at least one storage device for at least temporarily storing at least one control dataset, wherein the control dataset or datasets include(s) control data for positioning and/or for focusing individual laser pulses in the cornea, and where-in the control dataset or datasets include(s) control data for positioning the patient interface.
Maeda, in a similar field of endeavor, is directed towards a corneal surgery apparatus. Maeda discloses wherein the control device comprises at least one storage device for at least temporarily storing at least one control dataset, wherein the control dataset or datasets include(s) control data for positioning and/or for focusing individual laser pulses in the cornea (e.g. Par. [0027]: “The computer 209 inputs various data for a necessary surgical condition, and performs calculation, display, storage and the like of data on laser irradiation control.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gertner in view of Maeda, Bor, and Gertner’330 to include wherein the control device comprises at least one storage device for at least temporarily storing at least one control dataset, wherein the control dataset or datasets include(s) control data for positioning and/or for focusing individual laser pulses in the cornea as taught by Maeda, because doing so would store the data required for positioning the laser pulses.
However, Gertner in view of Maeda, Bor, and Gertner’330 fails to disclose where-in the control dataset or datasets include(s) control data for positioning the patient interface. Yee, in a similar field of endeavor, is directed towards intrastromal refractive correction systems and methods. Yee discloses where-in the control dataset or datasets include(s) control data for positioning the patient interface (e.g. Par. [0062]: eye is aligned with the patient interface using saved thresholds; Par. [0049]: storage system used for storing data).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gertner in view of Maeda, Bor, and Gertner’330 to include where-in the control dataset or datasets include(s) control data for positioning the patient interface as taught by Yee, because doing so would store the data required for the accurate positioning of the patient interface.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fu et al. (US 2018/0008461, of record) is directed towards lenticular laser incision using guided maps.
Neal et al. (US 2017/0027437, of record) is directed towards an optical imaging and measurement system for cataract surgery and treatment planning (e.g. Par. [0012]: determining tilt and decentration of the lens).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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