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
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.
(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.
Claims 1-3, 5-6, 10-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Friedman (US 2016/0310319).
Regarding claims 1 and 11-12, Friedman discloses a system and computer readable medium for corneal treatment for a subject comprising:
an illumination system including a light source and optical elements, wherein the illumination system is configured to generate cross-linking in at least one selected region of a cornea treated with a cross-linking agent by delivering photoactivating light to the at least one selected region of the cornea according to one or more photoactivation parameters (claims 1, 14); and
a controller configured to receive input relating to one or more treatment parameters including the one or more photoactivation parameters, wherein the controller is configured to execute program instructions stored on one or more non-transitory computer-readable storage media to output information for adjusting the one or more treatment parameters (claims 1, 14), wherein the program instructions include:
a first set of program instructions that determines, from the input relating to the one or more treatment parameters, a distribution of cross-links for the at least one selected region of the cornea (claims 1, 14);
a second set of program instructions the determines, from the distribution of cross-links, a shape change for the cornea ([0082]-[0084], claims 1, 14); and
wherein, in response to the output from the controller, the illumination system is configured to adjust at least one of the one or more photoactivation parameters for delivering the photoactivating light (claims 1, 14) and
wherein the controller determines the shape change for the cornea according to a biomechanical model, and at least one of a biochemical model or an optical model (e.g. finite element biomechanical computer model as disclosed in [0034] and claim 5; in combination with photochemical model of claim 14; [0034], [0079], [0080] and optical coherence tomography (OCT) of [0034] which can be considered an optical model).
Regarding claim 2, Friedman additionally discloses a system wherein the one or more treatment parameters includes at least one of a soak time for the cross-linking agent, a pulse duration for the photoactivating light, an irradiance of the photoactivating light, a dose of the photoactivating light, an illumination pattern for the photoactivating light, or a concentration of oxygen applied to the cornea ( e.g. on/off duty cycle of the pulse light treatment, pulse rate frequency, irradiance and dose, as well as addition of oxidizers; [0048], [0049], [0051], [0057]),
Regarding claims 3 and 15, Friedman additionally discloses a system wherein the second set of program instructions determines (i) a pre-treatment state of the cornea based on a pre-treatment shape and a pre-treatment intraocular pressure of the cornea, and (ii) the shape change for the cornea based on the pre-treatment state of the cornea and the distribution of cross-links (e.g. pre-and post treatment state of the cornea and modeling the refractive change; [0034], [0077], [0082]-[0084]).
Regarding claim 5 and 14, Friedman additionally discloses a system further comprising an oxygen source and an oxygen delivery device configured to provide a concentration of oxygen from the oxygen source to the at least one selected region of the cornea, wherein the one or more treatment parameters further relates to the concentration of oxygen (e.g. oxygen source and oxygen delivery device of claim 2, wherein the treatment parameter relates to the concentration of oxygen; [0057], claim 2).
Regarding claim 6, Friedman additionally teaches wherein the controller is further configured to calibrate the biomechanical model by calibrating, based on measured reference data, variable model parameters relating to the corneal elasticity and the stiffening associated with cross-links (e.g. photnokinetic model of claim 14; [0034], [0079], [0080], claims 5 and 14).
Regarding claim 10 and 16, Friedman additionally discloses a system wherein the first set of program instructions determines the distribution of cross-links from (i) reactions involving reactive oxygen species (ROS) including at least singlet oxygen, peroxides, superoxides, and hydroxyl radicals, and (ii) reactions not involving oxygen (e.g. “The controller includes computer-readable storage media storing: (A) a first set of program instructions for determining, from the input, cross-linking resulting from reactions involving reactive oxygen species (ROS) including at least peroxides, superoxides, and hydroxyl radicals, and (B) a second set of program instructions for determining, from the input, cross-linking from reactions not involving oxygen”; [0024])
Regarding claim 13, Friedman additionally discloses a non-transitory computer-readable media wherein the one or more treatment parameters include one or more photoactivation parameters, and the computer-executable instructions further cause the controller to cause an adjustment to at least one of the one or more photoactivation parameters for an illumination system, the illumination system configured to generate the cross-linking in the at least one selected region of the cornea by delivering photoactivating light to the at least one selected region of the cornea according to the one or more photoactivation parameters (e.g. adjustment of photoactivation, [0033], also [0048], [0049], [0051], [0057]).
Regarding claim 18, Friedman additionally discloses a non-transitory computer-readable media wherein the controller determines the shape change for the cornea according to a biomechanical model that models corneal elasticity and a stiffening associated with cross-links (e.g. models as taught in [0034], [0079], [0080], claims 5, 14).
Allowable Subject Matter
Claims 4, 7-9, 17, and 19-20 are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/ Primary Examiner, Art Unit 3792
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