DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/10/2025 has been entered.
Response to Arguments
Regarding the previous 112b indefiniteness rejections, applicant’s amendments and related arguments are persuasive in overcoming this rejection and it is hereby withdrawn.
Regarding the 103 rejection, applicant’s arguments have been fully considered but are not persuasive. Specifically, applicant’s arguments are not commensurate in scope with the claimed invention. For clarity, the limitation in question is “the delivery system including a light source configured to emit UV light at a power between 30 mW and 1 W, and a mirror array configured to direct the dose of UV light to the eye at a rate of 30mW/cm2”. First and foremost, it has always been the examiner’s position that the delivery system of Herekar, specifically the light source (UV light source 120, as discussed in at least Par 0027) and mirror (spatial light modulator 124, as discussed in at least Pars 0023-26) are structurally capable of emitting light having the claimed power and directing light having the claimed power density. This same position is maintained in the current office action, as applicant has provided no evidence or explanation as to why the light source and mirror of Herekar are not capable of operating in the claimed manner. Specifically, applicant’s arguments relate solely to the references not explicitly teaching the claimed power density. However, the limitation does not require the prior art to explicitly teach the claimed rate/power density in order to read on a mirror configured to direct light at the claimed rate. As pointed out in previous office actions, MPEP 2114 clearly states that… "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. It’s unclear how applicant’s mirror is structurally different than the mirror taught by Herekar. Stated differently, the examiner takes the position that Herekar teaches all of the necessary structural elements, i.e. a spatial light modulator (124), to be inherently capable of providing the claimed rate. It is emphasized that this is the same exact mirror claimed/disclosed by applicant, and therefore is capable of operating at the same rate. Similarly, the UV light source (120) is disclosed as a laser, lamp or LED which are all configured to emit the claimed power. Applicant has provided no arguments or evidence as to why the spatial light modulator and light source of Herekar are not capable of operating in the claimed manner. Therefore, the examiner maintains that the same structure is inherently capable of providing the same/claimed effect or result. Since applicant’s arguments do not apprise the examiner of any errors, as it relates to the specific structure of the mirror or light source and how these structures are inherently capable of operating, the examiner is maintaining the previous position that the light source and mirror of Herekar are inherently capable of operating in the claimed manner. If applicant disagrees, then it is recommended that applicant provide arguments/evidence as to why this is not the case.
Regarding the Chan reference, in order to provide compact prosecution, the examiner has found a new reference (Herakar ‘060), and is no longer using the Chan reference. Therefore, applicant’s arguments regarding Chan are moot, as this reference is no longer being used in the current 103 rejection. Specifically, even if the claims explicitly required emitting/directing light with the claimed power and power density (which the examiner does not concede), such light emission is obvious based on this newly applied reference; see new 103 rejection below.
Claim Objections
Claim 43 is objected to because of the following informalities: the limitation “the delivery system including a light source configured to emit UV light at a power between 30 mW and 1 W” should be “the delivery system including a light source configured to emit the UV light at a power between 30 mW and 1 W”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 43, 46, 53 and 61-64 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Herekar (US 2008/0015660) in view of Mrochen et al. (US 2010/0069894) and Lubatschowski et al. (US 2011/0118712) further in view of US 2010/0057060 to Herekar (herein referred to as Herekar ‘060).
[Claim 43] Herekar discloses a system for treating an eye having a cornea (ocular treatment system for oculoplasty/keratoplasty, #100), the system comprising:
an eye-tracking system configured to generate image data indicative of photons reflected from the eye (one or more topographical sensors, wavefront sensors and/or eyetracker for online real-time corrections; Par 0039);
a delivery system for directing a dose of ultraviolet light at 30 mW/cm2 to the eye to activate a cross-linking agent applied to the eye (delivery system including an ultraviolet/blue light source, #120, and a pixel-based spatial light modulator (SLM), #124, the SLM including a two-dimensional array of controllable micro-mirrors, the array being configured to selectively direct light according to a spatial pattern of intensities, as well as other optics 122, 126 and 128. At the very least these optics are capable of delivering the claimed dose of light. If applicant disagrees; see Herekar '060 below), the delivery system including a light source configured to be applied with a power between 30 mW and 1W (the ultraviolet/blue light source 120 is structurally capable of being applied with the claimed power/wattage, if applicant disagrees see Herekar '060 below) and a mirror array (the SLM) [pars. 0008-0010, 0023, 0025-0026]; and
a controller (control electronics, not shown) configured to provide, in response to the condition of the eye, one or more control signals to programmatically control the delivery system (the two-dimensional array of controllable micro-mirrors is configured to selectively direct light according to a predetermined spatial pattern of intensities that is updated based on the feedback loop providing topographical, wavefront and eyetracker based real-time corrections) [pars. 0008-0010, 0023, 0025-0026, 0039, 0045],
wherein the mirror array has a plurality of mirrors arranged in rows and columns (pixel-based spatial light modulator 124 is a two-dimensional array of controllable micro-mirrors, e.g. DLP projector available from Texas Instruments), the plurality of mirrors adapted to selectively direct the light toward the eye according to a pixelated intensity pattern having pixels corresponding to the plurality of mirrors in the mirror array, the plurality of mirrors alignable according to one or more mirror-control signals, the controller providing the one or more mirror-control signals to programmatically align the plurality of mirrors in the array of mirrors such that the pixelated intensity pattern emerges from the mirror array responsive to the light delivered to the plurality of mirrors (Pars 0025-26), the pixelated intensity pattern being proportionate to a length of time the photoactivating light is directed by the plurality of mirrors (inherent characteristic/functionality of DMDs, i.e. statement of fact; see MPEP 2112 and 2114 and pertinent prior art references in the conclusion section, as well as the response to arguments section. Specifically, intensity (Watt/cm2) is inherently proportionate to the amount of time light is emitted)
wherein in response to the one or more control signals, the delivery system sequentially applies different respective doses of light to the first customized treatment zone of the cornea and the second customized treatment zone of the cornea, such that the first customized treatment zone includes a first pattern (e.g. circular patterns may be generated) [par. 0051], the second customized treatment zone includes a second pattern and the first customized treatment zone and the second customized treatment zone collectively constitute a non-uniform pattern of circular patterns to produce a change in optical power that treats the condition of the eye (an effective dose of light radiation is applied according the spatial pattern of intensities and feedback received from the topographical sensors (corneal topography), wavefront sensor (photosensitizer concentration) and eyetracker (eye position); depending on the feedback different doses will be applied to different treatment regions of the eye i.e. treatment zones in a sequential manner e.g. sequential annuli. In the context of non-uniform patterns, the applicant’s specification clearly indicates this means non-uniform intensity profiles. The controller adjusts the delivered intensity to different areas (zones) of the eye which form treatment patterns based on feedback of the topography and photosensitizer concentration. Thus the controller is configured to generate patterns with zones of non-uniform intensity profiles.) [pars. 0008-0010, 0034]; and
While the examiner believes Herekar implicitly discloses sequentially applying different respective doses of light to the plurality of treatment zones. Mrochen is also provided for an explicit recitation.
Mrochen discloses an analogous system for activating a cross-linking agent (photosensitizer, e.g. riboflavin) applied to the cornea comprising a controller for controlling/regulating laser radiation, from a laser radiation source (#1), focused onto corneal tissue using a light modulator (#20) based on information received from an observation device for determining the topography of the cornea in real-time (#9) and a measuring device for measuring energy/intensity/time distribution of the laser radiation (#10) [pars. 0036, 0047, 0055]. A signal is passed to the measuring device to the controller in order control the temporal progression of radiation in a treatment plane in accordance with a predetermined program. If deviations arise with regard to a measured parameter in comparison with the set progression of the program, the controller can change the radiation in such a way-in the manner of a closed control loop-that the stated parameter again lies within the set range. Furthermore, photosensitizer (riboflavin) concentration and topography may be provided to the controller in order to ascertain optimal values for the treatment with regard to dose and temporal progression of the intensity [pars. 0076-0080].
It would have been obvious to one of ordinary skill in the art at the time the invention was made to configure the controller of the system to provide sequential light doses appropriate for crosslinking photosensitizers in the cornea based on feedback related to photosensitizer concentration from a spectrophotometer or topography or eye movement from other measuring devices, as taught by Herekar and Mrochen, in order to implement real-time safety features e.g. ensure the proper dose of radiation is delivered to a particular region of the cornea based on the concentration of photosensitizer present and any change in topography or position of the eye.
Herekar in view of Mrochen disclose applying customized circular patterns to corneal tissue but do not explicitly disclose applying ellipse patterns nor do they explicitly teach a video eye-tracking system.
Lubatschowski discloses an analogous laser eye surgery system for correction of vision wherein concentric rings serve to uniformly change the refractive power of the eye lens, while astigmatism is corrected with ellipses [pars. 0020, 0040-0041]. Furthermore, Lubatschowski discloses a video eye tracking system [par. 0051]. As discussed above, the examiner contends that any/all video eye tracking systems inherently operate/function by generating video image data indicative of photons reflected from the eye; MPEP 2114.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to configure the corneal crosslinking treatment system rendered obvious by Herekar in view of Mrochen to implement first and second ellipse patterns as taught by Lubatschowski in order to correct for astigmatism present in the eye. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute the generic eye trackers taught by either Herekar or Mrochen for the video eye tracking system taught by Lubatschowski, as a simple substitution of one known eye tracking system for another to obtain predictable results.
If applicant disagrees with the examiner’s position that Herekar teaches a delivery system that is capable of delivering the claimed intensity and a light source that is capable of emitting the claimed power/wattage, then such a feature is made obvious by Herekar ‘060. Specifically, Herekar ‘060 disclose a laser treatment device for crosslinking corneal tissue (At least Abstract, Pars 0009 and 0018) including a UV laser source (Par 0019) that emits light at a power density from 1 mW/cm2 to 30 mW/cm2 (Par 0022). The examiner contends that based on a spot size of “up to about 12 mm” (Par 0023), the UV laser source must be inherently capable of emitting a laser beam with a power of 30 mW to 1 W, in order to achieve the disclosed power densities, as cited above. MPEP 2144.05 states…In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Therefore, it would have been obvious to one of ordinary skill in the art to modify/configure the delivery system and light source taught by Herekar so that it is capable of emitting the power density and power taught by Herekar ‘060, as these parameters, i.e. a power density of 30 mW/cm2 and a power of 30 mW to 1 W, are known to be effective for corneal crosslinking and therefore would be obvious to use/choose/try to obtain predictable results. It is emphasized that applicant has no criticality or unexpected results for any of the claimed parameters.
[Claim 46] Herekar discloses the feedback system includes an optical coherence tomography (OCT) system configured to provide additional information to the controller to control the delivery system [pars. 0028, 0044].
[Claim 53] Herekar discloses the information from the video eye-tracking system is configured to provide an orientation of astigmatism of the eye (refractive modifications/corrections including astigmatism which would include orientation of the astigmatism), and the controller is configured to determine the plurality of treatment zones according to the orientation of the astigmatism (astigmatism is characterized by a non-round shape of the surface of the cornea which would require a non-uniform intensity pattern, i.e. different treatment zones, to correct the astigmatism) [pars. 0008, 0027, 0039-0040].
[Claim 61] Herekar discloses an applicator (comprising a storage tank, valve and orifice) configured to apply the cross-linking agent (photosensitizer) to the eye [par. 0023].
[Claim 62] Herekar discloses the information from the video eye-tracking system includes at least one of corneal topography, corneal strength, or corneal thickness of the eye [par. 0039].
[Claim 63] Herekar in view of Mrochen, Lubatschowski and Herekar ‘060 render obvious the video eye-tracking system of claim 43. Herekar discloses the eye-tracking system (eyetracker e.g. sensor that provides image data related to eye position, Fig. 5 #Sensor 1) is configured to provide the controller with real-time position data relating to movement of the eye (the present invention incorporates one or more topographical sensors, wavefront sensors, and/or an eyetracker for real-time corrections, and provides a feedback loop to the controllable spatial light modulator to derive modifications of the predetermined spatial pattern from the various data provided) [pars. 0039, 0044; Figure 5].
[Claim 64] Herekar discloses the delivery system, the mirror array being configured to selectively direct the light according to a pixelated intensity pattern (spatial pattern of intensities), the pixelated intensity pattern having a plurality of pixels corresponding to a plurality of mirrors (two-dimensional array of controllable micro-mirrors) in the mirror array [pars. 0008-0010, 0023, 0025-0026];
Claim 45 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Herekar, Mrochen, Lubatschowski and Herekar ‘060 as applied to claim 43 above, and further in view of Huang et al. (US 2007/0282313).
[Claim 45] Herekar in view of Mrochen, Lubatschowski and Herekar ‘060 renders obvious the video eye-tracking system but is silent regarding the system including a system of rotating Scheimpflug cameras.
Huang discloses an analogous system for guiding corneal surgery comprising the widely known Pentacam by Oculus Gmbh, Germany which can obtain corneal thickness maps in eyes [par. 0020]. Applicant’s specification, in paragraph [0065], discloses the rotating Scheimpflug cameras are part of an Oculus Pentacam.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the video eye-tracking system to include an Oculus Pentacam rotating Scheimpflug cameras system as taught by Huang since this is well within the scope of one having ordinary skill in the art and merely provides a predictable result of using/substituting one known feedback system for another known feedback system for measuring corneal thickness/topography.
Claim 47 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Herekar, Mrochen, Lubatschowski and Herekar ‘060 as applied to claim 43 above, and further in view of applicant’s admitted prior art (AAPA).
[Claim 47] Herekar in view of Mrochen, Lubatschowski and Herekar ‘060 are discussed above, but fail to explicitly teach a supersonic shear imaging corneal elasticity measurement system.
AAPA discloses supersonic shear imaging corneal elasticity measurement systems are known in the art for providing feedback of corneal information [applicant’s specification, paragraph 0074].
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the feedback system taught by Herekar to include a supersonic shear imaging corneal elasticity measurement system as taught by AAPA since this is well within the scope of one having ordinary skill in the art and merely provides a predictable result of using/substituting one known feedback system for another known feedback system.
Claim 49 is rejected under 35 U.S.C. 103(a) as being unpatentable over Herekar, Mrochen, Lubatschowski and Herekar ‘060 as applied to claim 43 above, and further in view of Jaycock et al. (“Interferometric technique to measure biomechanical changes in the cornea induced by refractive surgery” J Cataract Refract Surg. 2005 Jan; 31(1):175-84).
[Claim 49] Herekar in view of Mrochen, Lubatschowski and Herekar ‘060 render obvious the system of claim 43 but is silent regarding an interferometry system.
Jaycock discloses the use of interferometry to measure biomechanical properties of the cornea [whole document].
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system to include an interferometry system as taught by Jaycock since this is well within the scope of one having ordinary skill in the art and merely provides a predictable result of using/substituting one known feedback system for another known feedback system.
Claim 50 is rejected under 35 U.S.C. 103(a) as being unpatentable over Herekar, Mrochen, Lubatschowski and Herekar ‘060 as applied to claim 43 above, and further in view of Lai et al. (US 2003/0071968).
[Claim 50] Herekar in view of Mrochen, Lubatschowski and Herekar ‘060 render obvious the system of claim 43 but is silent regarding a multi-slit lamp system.
Lai discloses the use of a multi slit lamp system to determine a corneal thickness profile [abstract; pars. 0006-0007; claim 1].
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system to include a multi slit lamp system as taught by Lai since this is well within the scope of one having ordinary skill in the art and merely provides a predictable result of using/substituting one known feedback system for another known feedback system.
Claim 51 is rejected under 35 U.S.C. 103(a) as being unpatentable over Herekar, Mrochen, Lubatschowski and Herekar ‘060 as applied to claim 43 above, and further in view of Bueno et al. (“Corneal polarimetry after LASIK refractive surgery” J Biomed Opt. 2006).
[Claim 51] Herekar in view of Mrochen, Lubatschowski and Herekar ‘060 render obvious the system of claim 43 but is silent regarding a polarimetry system.
Bueno discloses the use of a polarimetry system to follow the biomechanical and optical changes of the cornea after refractive surgery or for the early diagnosis of different corneal pathologies [abstract].
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system to include a polarimetry system as taught by Bueno since this is well within the scope of one having ordinary skill in the art and merely provides a predictable result of using/substituting one known feedback system for another known feedback system.
Claim 52 and 56-57 are rejected under 35 U.S.C. 103 as being unpatentable over Herekar, Mrochen, Lubatschowski and Herekar ‘060 as applied to claim 43 above, and further in view of Sand (US 4,976,709).
[Claims 52, 56] Herekar in view of Mrochen, Lubatschowski and Herekar ‘060 render obvious the video eye-tracking system of claim 43 but is silent regarding generating an optical power contour map.
Sand discloses an analogous corneal treatment method for refractive correction based on optically induced shrinkage comprising measuring an optical power contour map of the cornea (corneal mapping system for contour determination), analyzing optical power (refractive power) at one or more zones of the cornea, and determining changes to the optical power at the one or more zones of the cornea [col. 6, lines 1-22].
It would have been obvious to one of ordinary skill in the at the time the invention was made to modify the video eye-tracking system to measure the shape of the cornea based on an optical power contour map of one or more zones and determine changes to optical power at the one more zones, as taught by Sand, in order to determine the pattern for cross-linking appropriate for producing the desired shape of the cornea.
[Claim 57] Herekar discloses the controller is configured to modify the pixelated intensity pattern to selectively activate the cross-linking agent in the pattern but is silent regarding flattening the curvature of corneal regions, i.e. treatment zones, having greater curvature.
Sand discloses that increasing the radius of curvature of the cornea will correct myopia (nearsightedness), and reduction of this parameter will correct hypermetropia (farsightedness) [col. 6, lines 5-8].
It would have been obvious to one of ordinary skill in the art at the time the invention was made to generate patterns of the initiating element (light) to produce cross-linking activity that causes the cornea to flatten in certain treatment zones having greater curvature to correct for hypermetropia and other conditions, as taught by Sand.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2012/0209051 to Blumenkranz discloses a similar optical cross-linking system that uses UVA light at the claimed power density (at least Pars 0048 and 0056) and power (at least Par 0064).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796