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 .
Double Patenting – Non-Statutory
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12016794 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant specification recites, “deliver a plurality of doses of photoactivating light at the plurality of treatment zones.” Claim 1 of U.S. Patent No. 12016794 B2 recites, “defined by a plurality of treatment zones on the cornea to generate cross-linking activity, the plurality of treatment zones including at least a first treatment zone and a second treatment zone, the first treatment zone providing a first dose of the photoactivating light, the second treatment zone providing a second dose of the photoactivating light, the first dose being greater than the second dose…”. The recitation of a first and second dose and a first and second treatment zone is within the scope of claim 1 (plurality of treatment zones; plurality of doses). Although the recitation is not identical, they are not patentably distinct.
Claim 2 of U.S. Patent No. 12016794 B2 includes the subject matter of claims 2 and 18 of the instant application.
Claims 17 of U.S. Patent No. 12016794 B2 includes the subject matter of claims 3 and 17 of the instant application.
Claim 4 of U.S. Patent No. 12016794 B2 includes the subject matter of claim 4 of the instant application.
Claim 5 of U.S. Patent No. 12016794 B2 includes the subject matter of claim 5 of the instant application.
Claim 7 of U.S. Patent No. 12016794 B2 includes the subject matter of claim 7 of the instant application.
Claim 8 of U.S. Patent No. 12016794 B2 includes the subject matter of claim 8 of the instant application.
Claim 9 of U.S. Patent No. 12016794 B2 includes the subject matter of claim 9 of the instant application.
Claim 10 and 20 of U.S. Patent No. 12016794 B2 includes the subject matter of claims 10 and 20 of the instant application.
Claim 11 of U.S. Patent No. 12016794 B2 includes the subject matter of claim 11 of the instant application.
Claim 12 of U.S. Patent No. 12016794 B2 includes the subject matter of claim 12 of the instant application.
Claim 13 of U.S. Patent No. 12016794 B2 includes the subject matter of claim 13 of the instant application.
Claim 14 of U.S. Patent No. 12016794 B2 includes the subject matter of claim 14 of the instant application.
Claim 15 of U.S. Patent No. 12016794 B2 includes the subject matter of claim 15 of the instant application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A) a light source (means) configured to provide photoactivating light that photoactivates a cross- linking agent applied to a cornea (functional language). The term “light source”, recited in claims 1, 5, 7, 13, and 16, will be interpreted according to the instant specification as being one of UV light (para. [0050]), UV LED, or a UV laser source (para. [0059]).
B) one or more optical elements (means) configured to receive the photoactivating light and produce a beam that defines a spot of the photoactivating light (functional language). The term “optical elements,” recited in claims 1, 3, 7, 13, and 16-18 will be interpreted according to the instant specification as being one of a digital micro-mirror device (DMD) (para. [0039]), an XY scanning mirror pair (para. [0064]), or a galvanometer pair (par. [0065]).
C) a scanning system (means) configured to receive the beam of the photoactivating light and to scan the spot of the photoactivating light along a first axis and a second axis to form a scan pattern defined by a plurality of treatment zones on the cornea to deliver a plurality of doses of photoactivating light at the plurality of treatment zones (functional language). The term “scanning system,” recited in claims 1, 2, 4, 5, 7, and 13 will be interpreted according to the instant specification as being one of an XY scanning system (para. [0064]) or a galvanometer pair (para. [0065]).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 10 and 20, the claims recite, “the cross-linking activity.” The recitations lack antecedent basis in the claims. The claim is therefore indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-5, 7, 10, 16, and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Friedman (US 20150265762 A1, "Friedman").
Regarding independent claim 1, Friedman teaches a system for treating an eye (para. [0008]: "a system includes a treatment system that provides a treatment to a corneal tissue."), comprising: a light source (Fig. 1, Fig. 3; light source 110) configured to provide photoactivating light that photoactivates a cross- linking agent applied to a cornea (para. [0049]: "Once the cross-linking agent 130 has been applied to the cornea 2, the cross-linking agent 130 is initiated by the light source 110 (i.e. the initiating element) to cause cross-linking agent 130 to absorb enough energy to generate free radicals within the cornea 2"; para. [0064]: "By scanning over selected regions 5 of a plane 6 at a particular depth within the cornea 2, the controller 120 can control the activation of the cross-linking agent 130 within the cornea 2 according to a three dimensional profile. In particular, the controller 120 can utilize the laser scanning technology of the laser scanning device 300 to strengthen and stiffen the corneal tissues by activating cross-linking in a three-dimensional pattern within the cornea 2."; [0055]: "The optical elements 112 may further include filters for partially blocking wavelengths of light emitted by the light source 110 and for advantageously selecting particular wavelengths of light to be directed to the cornea 2 for activating the cross-linking agent 130."); one or more optical elements (Fig. 1, Fig. 3; optical elements 112) configured to receive the photoactivating light and produce a beam that defines a spot of the photoactivating light (para. [0055]: "The optical elements 112 can be used to focus the light emitted by the light source 110 to a particular focal plane within the cornea 2, such as a focal plane that includes the mid-depth region 2B. In addition, according to particular embodiments, the optical elements 112 may include one or more beam splitters for dividing a beam of light emitted by the light source 110, and may include one or more heat sinks for absorbing light emitted by the light source 110."); and a scanning system (Fig. 3; laser scanning device 300) configured to receive the beam of the photoactivating light (Fig. 3; para. [0061]: "beam of light 341") and to scan the spot of the photoactivating light along a first axis and a second axis to form a scan pattern ([0061]-[0064]: "FIG. 3 provides an example delivery system adapted as a laser scanning device 300 for delivering light to the cornea 2 employing laser scanning technology…By rapidly scanning the beam of light 341 over the mirrors in the mirror array 344, the mirror array 344 outputs a light pattern 345, which has a two dimensional intensity pattern…The mirror array 344 can include an array of small oscillating mirrors, controlled by mirror position motors 347. The mirror position motors 347 can be servo motors for causing the mirrors in the mirror array 344 to rotate so as to alternately reflect the beam of light 341 from the light source 340 toward the cornea 2 (e.g., alternately directed to be part of the pattern of light delivered to the cornea 2 via one or more optical elements). The controller 120 can control the light pattern 345 generated in the mirror array 344 using the mirror position motors 347. In addition, the controller 120 can control the depth within the cornea 2 that the light pattern 345 is focused to by controlling the location of the focal depth of the objective lens 346 relative to the corneal surface 2A. For example, the controller 120 can utilize an objective lens position motor 348 to raise and/or lower the objective lens 346 in order to adjust the focal plane 6 of the light pattern 345 emitted from the mirror array 344. By adjusting the focal plane 6 of the light pattern 345 using the objective lens motor 348, and controlling the two-dimensional intensity profile of the light pattern 345 using the mirror position motors 347, the controller 120 is adapted to control the delivery of the light source 110 to the cornea 2 in three dimensions. The three-dimensional pattern is generated by delivering the UV light to selected regions 5 on successive planes (parallel to the focal plane 6), which extend from the corneal surface 2A to the mid-depth region 2B within the corneal stroma. The cross-linking agent 130 introduced into the selected regions 5 is then activated as described above."; "three-dimensional pattern" means there are at least 2 axis); para. [0109]: "The treatment plan can be characterized by one or more applications of the cross-linking agent 1032 to achieve desired distributions within the cornea 2 and one or more energy doses of the initiating element 1040 delivered via optical elements according to desired patterns (e.g., via a DMD device or a scanning mirror system"; para. [0131]: "Alternatively, the illumination source may include a multiple line generator using an optical grating or a scanning mirror system to selectively direct the light to the corneal tissue as the slits of light. The slits of UV light illuminate a treatment zone on the cornea having a diameter of 9 mm. ) defined by a plurality of treatment zones (para. [0054] discloses where a controller can control regions of the eye strengthened by cross-linking: "…the controller 120 can control the particular regions of the cornea 2 that are strengthened and stabilized through cross-linking of the corneal collagen fibrils. In an implementation, the cross-linking agent 130 can be applied generally to the eye 1, without regard to a particular region of the cornea 2 requiring strengthening, but the light source 110 can be directed to a particular region of the cornea 2 requiring strengthening, and thereby control the region of the cornea 2 wherein cross-linking is initiated by controlling the regions of the cornea 2 that are exposed to the light source 110." This demonstrates that there are a plurality of treatment zones, or regions, of the cornea) on the cornea to deliver a plurality of doses of photoactivating light at the plurality of treatment zones (para. [0102]: "Similar to the system 100 described in connection with FIG. 1, the controller 1020 operates the initiating element 1040 and/or associated optical elements to apply the initiating element 1040 to the eye 1 according to specified intensity patterns, energy doses, and/or timing intervals."; Energy doses is considered a plurality of doses; para. [0109]: "The treatment plan can be characterized by one or more applications of the cross-linking agent 1032 to achieve desired distributions within the cornea 2 and one or more energy doses of the initiating element 1040 delivered via optical elements according to desired patterns (e.g., via a DMD device or a scanning mirror system) to controllably activate cross-linking in the corneal tissue 2."), the scanning system further configured to spatially adjust doses of the photoactivating light delivered in respective portions of the scan pattern (para. [0054]:" The delivery system 100 also includes a controller 120 for controlling the operation of the optical elements 112 or the applicator 132, or both. By controlling aspects of the operation of the optical elements 112 and the applicator 132, the controller 120 can control the regions of the cornea 2 that receive the cross-linking agent 130 and that are exposed to the light source 110. By controlling the regions of the cornea 2 that receive the cross-linking agent 130 and the light source 110, the controller 120 can control the particular regions of the cornea 2 that are strengthened and stabilized through cross-linking of the corneal collagen fibrils. In an implementation, the cross-linking agent 130 can be applied generally to the eye 1, without regard to a particular region of the cornea 2 requiring strengthening, but the light source 110 can be directed to a particular region of the cornea 2 requiring strengthening, and thereby control the region of the cornea 2 wherein cross-linking is initiated by controlling the regions of the cornea 2 that are exposed to the light source 110."; para. [0067]: "[0067] Some embodiments may employ Digital Micromirror Device (DMD) technology to modulate the application of initiating light, e.g., UV light, spatially as well as temporally. Using DMD technology, a controlled light source is selectively reflected to provide the initiating light in a precise spatial pattern that is created by microscopically small mirrors laid out in a matrix on a semiconductor chip, known as a DMD.").
Regarding independent claim 16, Friedman teaches A system for treating an eye (para. [0008]: "a system includes a treatment system that provides a treatment to a corneal tissue."), comprising: a light source (Fig. 1, Fig. 3; light source 110) configured to provide photoactivating light that photoactivates a cross- linking agent applied to a cornea (para. [0049]: "Once the cross-linking agent 130 has been applied to the cornea 2, the cross-linking agent 130 is initiated by the light source 110 (i.e. the initiating element) to cause cross-linking agent 130 to absorb enough energy to generate free radicals within the cornea 2"; para. [0064]: "By scanning over selected regions 5 of a plane 6 at a particular depth within the cornea 2, the controller 120 can control the activation of the cross-linking agent 130 within the cornea 2 according to a three dimensional profile. In particular, the controller 120 can utilize the laser scanning technology of the laser scanning device 300 to strengthen and stiffen the corneal tissues by activating cross-linking in a three-dimensional pattern within the cornea 2."; [0055]: "The optical elements 112 may further include filters for partially blocking wavelengths of light emitted by the light source 110 and for advantageously selecting particular wavelengths of light to be directed to the cornea 2 for activating the cross-linking agent 130."); one or more optical elements (Fig. 1, Fig. 3; optical elements 112) configured to receive the photoactivating light and produce a pattern of photoactivating light (para. [0054]: "With reference to FIG. 1, the optical elements 112 may include one or more mirrors or lenses for directing and focusing the light emitted by the light source 110 to a particular pattern on the cornea 2 suitable for activating the cross-linking agent 130. The light source 110 may be an ultraviolet light source, and the light directed to the cornea 2 through the optical elements 112 may be an activator of the cross-linking agent 130.") defined by a plurality of treatment zones to deliver a plurality of doses of photoactivating light at the plurality of treatment zones. (para. [0054] discloses where a controller can control regions of the eye strengthened by cross-linking: "…the controller 120 can control the particular regions of the cornea 2 that are strengthened and stabilized through cross-linking of the corneal collagen fibrils. In an implementation, the cross-linking agent 130 can be applied generally to the eye 1, without regard to a particular region of the cornea 2 requiring strengthening, but the light source 110 can be directed to a particular region of the cornea 2 requiring strengthening, and thereby control the region of the cornea 2 wherein cross-linking is initiated by controlling the regions of the cornea 2 that are exposed to the light source 110." This demonstrates that there are a plurality of treatment zones, or regions, of the cornea."; para. [0102]: "Similar to the system 100 described in connection with FIG. 1, the controller 1020 operates the initiating element 1040 and/or associated optical elements to apply the initiating element 1040 to the eye 1 according to specified intensity patterns, energy doses, and/or timing intervals."; Energy doses is considered a plurality of doses; para. [0109]: "The treatment plan can be characterized by one or more applications of the cross-linking agent 1032 to achieve desired distributions within the cornea 2 and one or more energy doses of the initiating element 1040 delivered via optical elements according to desired patterns (e.g., via a DMD device or a scanning mirror system) to controllably activate cross-linking in the corneal tissue 2.").
Regarding claims 3 and 17, Friedman teaches the system of claim 1 and the system of claim 16 (see above), wherein the one or more optical elements includes a digital micro-mirror device (DMD). (para. [0012]: ".The treatment system may apply the pattern of ultraviolet light via a digital micro-mirror device (DMD)."; para. [0067]: "Some embodiments may employ Digital Micromirror Device (DMD) technology to modulate the application of initiating light, e.g., UV light, spatially as well as temporally."; para. [0109]: "The treatment plan can be characterized by one or more applications of the cross-linking agent 1032 to achieve desired distributions within the cornea 2 and one or more energy doses of the initiating element 1040 delivered via optical elements according to desired patterns (e.g., via a DMD device or a scanning mirror system) to controllably activate cross-linking in the corneal tissue 2.").
Regarding claim 4, Friedman teaches the system of claim 1 (see above), wherein the scanning system is configured to scan the spot of the photoactivating light along the first axis according to a first adjustable speed and to scan the spot of the photoactivating light along the second axis according to a second adjustable speed, the first adjustable speed and the second adjustable speed determining a dwell time for the spot of the photoactivating light over a portion of the scan pattern and determining the dose of the photoactivating light delivered for cross-linking activity in the portion of the scan pattern (para. [0056]: "one controller may be used to control the operation of the applicator 132, and thereby control the precise rate and location of the application of the cross-linking agent 130 to the cornea 2. Another controller may be used to control the operation of the optical elements 112, and thereby control with precision the delivery of the light source 110 (i.e. the initiating element) to the cornea 2 by controlling any combination of: wavelength(s), spectral bandwidth(s), intensity(s), power(s), location(s), depth(s) of penetration, and duration(s) of treatment."; para. [0054] discloses where different regions (treatment zones) of the cornea can be strengthened, and the regions that receive treatment can be controlled. The controller of scanning device 300 adjusts the speeds in both directions depending on the locations for activating cross-linking, as well as determining a dwell time (duration) and determining a dose (power) in each location).
Regarding claim 5, Friedman teaches the system of claim 1 (see above), wherein the light source is operable to adjust a power associated with the beam (par. [0071]: "To decrease the treatment time, and advantageously generate stronger cross-linking within the cornea 2, the initiating element (e.g., the light source 110 shown in FIG. 1) may be applied with a power between 30 mW and 1 W. The total dose of energy absorbed in the cornea 2 can be described as an effective dose, which is an amount of energy absorbed through a region of the corneal surface 2A. For example the effective dose for a region of the cornea 2 can be, for example, 5 J/cm.sup.2, or as high as 20 J/cm.sup.2 or 30 J/cm.sup.2. The effective dose delivering the energy flux just described can be delivered from a single application of energy, or from repeated applications of energy. In an example implementation where repeated applications of energy are employed to deliver an effective dose to a region of the cornea 2, each subsequent application of energy can be identical, or can be different according to information provided by the feedback system 400.) as the scanning system scans the spot of the photoactivating light over portions of the scan pattern (para. [0075]: "The feedback information 404 is based on the measurements 402 and provides input to the controller 120. The controller 120 then analyzes the feedback information 404 to determine how to adjust the application of the initiating element, e.g., the light source 110, and sends command signals 406 to the light source 110 accordingly."), the portions of the scan pattern receiving doses of the photoactivating light based on the power associated with the beam. (para. [0072]-[0075] disclose a feedback system 400 to identify adjustments to power and application of UV light; para. [0075]: "Furthermore, the delivery system 100 shown in FIG. 1 can be adapted to incorporate the feedback system 100 and can adjust any combination of the optical elements 112, the applicator 132, or the light source 110 in order to control the activation of the cross-linking agent 130 within the cornea 2 based on the feedback information 404 received from the feedback system 400.").
Regarding claim 7, Friedman teaches the system of claim 1 (see above), wherein the light source is operable to adjust a power associated with the beam (para. [0067]: "Some embodiments may employ Digital Micromirror Device (DMD) technology to modulate the application of initiating light, e.g., UV light, spatially as well as temporally. Using DMD technology, a controlled light source is selectively reflected to provide the initiating light in a precise spatial pattern that is created by microscopically small mirrors laid out in a matrix on a semiconductor chip, known as a DMD. Each mirror represents one or more pixels in the pattern of reflected light. The power and duration at which the light is reflected to provide the pixelated intensity pattern is determined as described elsewhere."), the one or more optical elements is operable to adjust a size of the spot of the photoactivating light produced by the beam (para. [0055]: "] The optical elements 112 can be used to focus the light emitted by the light source 110 to a particular focal plane within the cornea 2, such as a focal plane that includes the mid-depth region 2B. In addition, according to particular embodiments, the optical elements 112 may include one or more beam splitters for dividing a beam of light emitted by the light source 110, and may include one or more heat sinks for absorbing light emitted by the light source 110. The optical elements 112 may further include filters for partially blocking wavelengths of light emitted by the light source 110 and for advantageously selecting particular wavelengths of light to be directed to the cornea 2 for activating the cross-linking agent 130."), and the scanning system is operable to adjust a speed of the spot of the photoactivating light over portions of the scan pattern (para. [0062]: "By rapidly scanning the beam of light 341 over the mirrors in the mirror array 344, the mirror array 344 outputs a light pattern 345, which has a two dimensional intensity pattern. The two dimensional intensity pattern of the light pattern 345 is generated by the mirror array 344 according to, for example, the length of time that the beam of light 341 is scanned over each mirror in the mirror array 344. In particular, the light pattern 345 can be considered a pixilated intensity pattern with each pixel represented by a mirror in the mirror array 344 and the intensity of the light in each pixel of the light pattern 345 proportionate to the length of time the beam of light 341 scans over the mirror in the mirror array 344 corresponding to each pixel.").
Regarding claims 10 and 20, Friedman teaches the system of claim 1 and the system of claim 16 (see above), further comprising a photodiode (para. [0104]: “Generally, the dosimetry system(s) 1060 include sensors (e.g., cameras) to measure characteristics of the corneal tissue 2 (e.g., images indicating fluorescence activity).”) configured to receive fluorescent light from the cornea to monitor the cross-linking activity (para. [0104]: "The system 1000a further includes the fluorescence dosimetry system(s) 1050. The dosimetry system(s) 1050 are configured to dynamically monitor the distribution of cross-linking agent in the corneal tissue 2. Generally, the dosimetry system(s) 1060 include sensors (e.g., cameras) to measure characteristics of the corneal tissue 2 (e.g., images indicating fluorescence activity), and outputs to convey signals indicative of the measured characteristics to the controller 1020 such that the distribution of the cross-linking agent can be determined by analyzing the measured characteristics. The dosimetry system(s) 1060 can capture cross-sectional images of fluorescence activity (which indicates the distribution of the cross-linking agent along the cross-sectional region) via an Optical Coherence Tomography ("OCT") system 1050a and/or a Scheimpflug system 1050b").
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.
Claims 2 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman (US 20150265762 A1, "Friedman") in view of Knox et al. (US 20120310223 A1, "Knox").
Regarding claims 2, Friedman teaches the system of claim 1 (see 102 rejections above). However, Friedman does not explicitly teach wherein the scanning system includes a galvanometer pair, the galvanometer pair including a first mirror configured to scan the spot of the photoactivating light along the first axis and a second mirror configured to scan the spot of the photoactivating light along the second axis.
Knox, in the same field of endeavor of laser eye treatment, discloses a method and system for modifying ocular tissue. Knox discloses wherein the scanning system (Fig. 19A; scanning system 1900) includes a galvanometer pair, the galvanometer pair including a first mirror configured to scan the spot of the photoactivating light along the first axis and a second mirror configured to scan the spot of the photoactivating light along the second axis (para. [0156]: "The two-dimensional galvanometer scanner can provide high speed re-targeting of the beam typically in about 20 microseconds. After the galvanometer, the beam is reflected from a deformable mirror 1904. This is controlled by computer, and changes shape in response to signals from the computer and controller 1911."; The deformable mirror 1904 before it changes shape can be considered a first mirror, and the deformable mirror after it changes shape can be considered a second mirror; para. [0173]: "Galvanometer controlled systems. In the case of scanning systems that use galvanometer-type of control systems, it is possible to address different points in the sample at high speeds in arbitrary patterns, resulting in complex gradient index possibilities. In this case, the localized index changes will depend on the laser power modulation and the local scanning speed. Using a two dimensional galvo system with a custom designed optical relay lens system, we wrote two dimensional gradient index structures in Thiol-ene doped with ITX. FIG. 26 shows some preliminary results obtained by driving the galvanometers in out-of phase repetitive patterns. These are commonly referred to as Lissajous patterns. It is possible to write two-dimensional gradient index patterns with radially symmetric index gradient using such a system, and the control system for such a writing procedure could use a combination of scan speed control and optical power control as discussed previously for the case of xyz scanning.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Friedman to include a galvanic pair to photoactivate a light along a first and second axis, as disclosed by Knox. One of ordinary skill would recognize that a galvanic pair would be an effective scanning component of a laser eye treatment system for scanning photoactivating light. One would also recognize that a galvanic pair would improve the treatment of corneal tissue to correct vision. It would have been obvious for one of ordinary skill to implement the galvanic pair of Knox in the system of Friedman to improve the delivery of photoactivating light to improve the treatment of the ocular tissue.
Regarding claim 18, Friedman teaches the system of claim 16 (see 102 rejections above). However, Friedman does not explicitly teach wherein the one or more ocular elements includes a galvanometer pair, the galvanometer pair including a first mirror configured to scan the spot of the photoactivating light along the first axis and a second mirror configured to scan the spot of the photoactivating light along the second axis.
Knox, in the same field of endeavor of laser eye treatment, discloses a method and system for modifying ocular tissue. Knox discloses wherein the one or more optical elements (Fig. 19A; optic scanning system 1900) includes a galvanometer pair, the galvanometer pair including a first mirror configured to scan the spot of the photoactivating light along the first axis and a second mirror configured to scan the spot of the photoactivating light along the second axis (para. [0156]: "The two-dimensional galvanometer scanner can provide high speed re-targeting of the beam typically in about 20 microseconds. After the galvanometer, the beam is reflected from a deformable mirror 1904. This is controlled by computer, and changes shape in response to signals from the computer and controller 1911."; The deformable mirror 1904 before it changes shape can be considered a first mirror, and the deformable mirror after it changes shape can be considered a second mirror; para. [0173]: "Galvanometer controlled systems. In the case of scanning systems that use galvanometer-type of control systems, it is possible to address different points in the sample at high speeds in arbitrary patterns, resulting in complex gradient index possibilities. In this case, the localized index changes will depend on the laser power modulation and the local scanning speed. Using a two dimensional galvo system with a custom designed optical relay lens system, we wrote two dimensional gradient index structures in Thiol-ene doped with ITX. FIG. 26 shows some preliminary results obtained by driving the galvanometers in out-of phase repetitive patterns. These are commonly referred to as Lissajous patterns. It is possible to write two-dimensional gradient index patterns with radially symmetric index gradient using such a system, and the control system for such a writing procedure could use a combination of scan speed control and optical power control as discussed previously for the case of xyz scanning.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Friedman to include a galvanic pair to photoactivate a light along a first and second axis, as disclosed by Knox. One of ordinary skill would recognize that a galvanic pair would be an effective optical scanning component of a laser eye treatment system for scanning photoactivating light. One would also recognize that a galvanic pair would improve the treatment of corneal tissue to correct vision. It would have been obvious for one of ordinary skill to implement the galvanic pair of Knox in the system of Friedman to improve the delivery of photoactivating light to improve the treatment of the ocular tissue.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Friedman (US 20150265762 A1, "Friedman") in view of Rubinfeld et al. (US 20140194957 A1, "Rubinfeld").
Regarding claim 8, Knox teaches the system of claim 7 (see 102 rejection above). Friedman further teaches adjusting the power associated with the beam, the size of the spot of the photoactivating light, and the speed of the spot of the photoactivating light (para. [0067]: "Some embodiments may employ Digital Micromirror Device (DMD) technology to modulate the application of initiating light, e.g., UV light, spatially as well as temporally. Using DMD technology, a controlled light source is selectively reflected to provide the initiating light in a precise spatial pattern that is created by microscopically small mirrors laid out in a matrix on a semiconductor chip, known as a DMD. Each mirror represents one or more pixels in the pattern of reflected light. The power and duration at which the light is reflected to provide the pixelated intensity pattern is determined as described elsewhere."; (para. [0055]: "] The optical elements 112 can be used to focus the light emitted by the light source 110 to a particular focal plane within the cornea 2, such as a focal plane that includes the mid-depth region 2B. In addition, according to particular embodiments, the optical elements 112 may include one or more beam splitters for dividing a beam of light emitted by the light source 110, and may include one or more heat sinks for absorbing light emitted by the light source 110. The optical elements 112 may further include filters for partially blocking wavelengths of light emitted by the light source 110 and for advantageously selecting particular wavelengths of light to be directed to the cornea 2 for activating the cross-linking agent 130."; para. [0062]: "By rapidly scanning the beam of light 341 over the mirrors in the mirror array 344, the mirror array 344 outputs a light pattern 345, which has a two dimensional intensity pattern. The two dimensional intensity pattern of the light pattern 345 is generated by the mirror array 344 according to, for example, the length of time that the beam of light 341 is scanned over each mirror in the mirror array 344. In particular, the light pattern 345 can be considered a pixilated intensity pattern with each pixel represented by a mirror in the mirror array 344 and the intensity of the light in each pixel of the light pattern 345 proportionate to the length of time the beam of light 341 scans over the mirror in the mirror array 344 corresponding to each pixel."). However, Friedman does not explicitly disclose adjusting the parameters of the photoactivating light to aerobic conditions in the cornea for the cross- linking activity.
Rubinfeld, in the same field of endeavor of laser eye surgery systems, discloses an ophthalmic treatment system using cross-linking. Rubinfeld discloses adjusting (photoactivating light parameters) to aerobic conditions in the cornea for cross- linking activity. (para. [0044]: "In some embodiments of the ophthalmic treatment systems, the light control device includes a manual or microprocessor-controlled intensity control device (e.g. a dimming mechanism or switch) so as to provide for gradual decreases and increases in the UVA light intensity. Without wishing to be bound by any particular theory, it is contemplated that the gradual intensity adjustment mitigates one or more of startling effect, fixation loss, de-centered treatment, and Bells phenomenon. In some embodiments, the dimming mechanism is configured to provide periods of decreased UVA light, such that tissue reoxygenation occurs, and periods of increased UVA light, such that cross linking occurs.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Friedman to include parameters of the photoactivation to be within aerobic conditions (oxygenation) in the cornea for cross-linking activity, as disclosed by Rubinfeld. One of ordinary skill would recognize that doing so would be beneficial in that doing so would provide increased periods of UV intensity where cross-linking occurs, and decreased periods of UV intensity, where reoxygenation occurs. As a result, this would promote healthy corneal tissue after the procedure. Therefore, it would have been obvious to include the parameter adjustment of light into aerobic conditions in the system of Friedman since Rubinfeld discloses benefits to inducing reoxygenation of corneal tissue.
Claims 9, 11, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman (US 20150265762 A1, "Friedman") in view of Tedford et al. (US 20160067086 A1, "Tedford").
Regarding claim 9, Friedman discloses The system of claim 1 (see 102 rejection above). However, Friedman does not explicitly disclose a photodiode configured to receive a portion of the beam of the photoactivating light to monitor a power of the beam of the photoactivating light.
Tedford, in the same field of endeavor of laser eye treatment systems, discloses an ophthalmic phototherapy device. Tedford discloses a photodiode configured to receive a portion of the beam of the photoactivating light to monitor a power of the beam of the photoactivating light (para. [0102]: "The sensor may include an array of one or more photodiodes, a camera of appropriate wavelength and time sensitivity, or another sensor capable of measuring the spatial and temporal irradiance profile of the delivered therapy. The resulting “beam profile” may then be analyzed through software within to the device to determine specific characteristics of the delivered therapy, including one or more of the following: diameter…total power…").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Friedman to include a photodiode for monitoring power of a beam of the photoactivating light, as disclosed by Tedford. One of ordinary skill would recognize that modifying the system of Friedman to include the photodiode of Tedford would improve the accuracy of the light dosing in Friedman. It would be an obvious improvement to include a photodiode to measure power and improve dosing accuracy since Tedford discloses modulating the beam output of photoactivating light measured by a photodiode to achieve a desired dosage.
Regarding claim 11, Friedman teaches the system of claim 10 (see 102 rejection above). However, Friedman does not explicitly disclose wherein the photodiode receives fluorescent light from a portion of the scan pattern corresponding to a position of the spot of the photoactivating light along the first axis and the second axis.
Tedford discloses wherein the photodiode receives fluorescent light from a portion of the scan pattern corresponding to a position of the spot of the photoactivating light along the first axis and the second axis. (para. [0102]: "In at least some embodiments, the device contains sensors (for example, sensor 754 of FIG. 7) to monitor the spatial or temporal irradiance pattern delivered to the patient. The sensor may include an array of one or more photodiodes, a camera of appropriate wavelength and time sensitivity, or another sensor capable of measuring the spatial and temporal irradiance profile of the delivered therapy. The resulting “beam profile” may then be analyzed through software within to the device to determine specific characteristics of the delivered therapy, including one or more of the following: diameter (as defined by a relative encircled energy metric, or a relative intensity metric), uniformity, pulse frequency, total power, maximum intensity, etc. In at least some embodiments, the logic circuit periodically or continuously monitors the beam profile as a method to validate of the delivered therapy. In at least some embodiments, the logic circuit uses the beam profile data as feedback to modulate the output of the device to achieve the desired dosage.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Friedman to include a photodiode that receives fluorescent light from a portion of the scan pattern corresponding to a position of the spot of the photoactivating light along the first axis and the second axis, as disclosed by Tedford. One of ordinary skill would recognize that modifying the system of Friedman to include the photodiode of Tedford would improve the accuracy of the light dosing in Friedman. It would be an obvious improvement to include a photodiode to measure power and improve dosing accuracy since Tedford discloses modulating the beam output of photoactivating light measured by a photodiode to achieve a desired dosage. It would have further been obvious to include a photodiode that receives light from a portion of the scan pattern corresponding to a first and second axis since Tedford discloses monitoring a spatial irradiation pattern using the photodiode to control the dosage.
Regarding claim 14, Friedman discloses the system of claim 1 (see 102 rejection above). Friedman further discloses one or more beamsplitters (para. [0055]: " In addition, according to particular embodiments, the optical elements 112 may include one or more beam splitters for dividing a beam of light emitted by the light source 110"; para. [0061]: "The beam of light 341 can be scanned over the mirrors in the mirror array 344 using, for example, one or more adjustable mirrors to direct the beam of light 341 to point at each mirror in turn. The beam of light 341 can be scanned over each mirror one at a time. Alternately, the beam of light 341 can be split into one or more additional beams of light using, for example, a beam splitter, and the resultant multiple beams of light can then be simultaneously scanned over multiple mirrors in the mirror array 344.") configured to direct fluorescent light from the cornea to a photodiode to monitor the cross-linking activity (para. [0104]: "The system 1000a further includes the fluorescence dosimetry system(s) 1050. The dosimetry system(s) 1050 are configured to dynamically monitor the distribution of cross-linking agent in the corneal tissue 2. Generally, the dosimetry system(s) 1060 include sensors (e.g., cameras) to measure characteristics of the corneal tissue 2 (e.g., images indicating fluorescence activity), and outputs to convey signals indicative of the measured characteristics to the controller 1020 such that the distribution of the cross-linking agent can be determined by analyzing the measured characteristics)."). However, Friedman doesn’t explicitly disclose a beam splitter configured to direct a portion of the beam of the photoactivating light to a first photodiode to monitor a power of the beam of the photoactivating light.
Friedman, in the same field of endeavor, discloses a beam splitter (para. [0070]: “Other light directing components can be used including, but not limited to, optical fibers, absorbing filters, reflective or absorbing polarizers, beamsplitters, and the like.”) and a first photodiode to monitor a power of the beam of the photoactivating light (para. [0102]: "In at least some embodiments, the device contains sensors (for example, sensor 754 of FIG. 7) to monitor the spatial or temporal irradiance pattern delivered to the patient. The sensor may include an array of one or more photodiodes, a camera of appropriate wavelength and time sensitivity, or another sensor capable of measuring the spatial and temporal irradiance profile of the delivered therapy. The resulting “beam profile” may then be analyzed through software within to the device to determine specific characteristics of the delivered therapy, including one or more of the following: diameter (as defined by a relative encircled energy metric, or a relative intensity metric), uniformity, pulse frequency, total power, maximum intensity, etc.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Friedman to include an additional beam splitter configured to direct a portion of the photoactivating light to a photodiode to monitor power of the beam, as disclosed by Tedford. One of ordinary skill would recognize that modifying the system of Friedman to include the photodiode of Tedford would improve the accuracy of the light dosing in Friedman. It would be an obvious improvement to include a photodiode to measure power and improve dosing accuracy since Tedford discloses modulating the beam output of photoactivating light measured by a photodiode to achieve a desired dosage. It would have further been obvious to include an additional beam splitter since Tedford discloses using a beam splitter to direct light, and Friedman discloses that more than one beam splitter may be implemented.
Regarding claim 15, Friedman, in combination with Tedford, discloses the system of claim 14 (see above). Friedman further discloses wherein the one or more beamsplitters includes a first beamsplitter (para. [0055]: "In addition, according to particular embodiments, the optical elements 112 may include one or more beam splitters for dividing a beam of light emitted by the light source 110"; para. [0061]: "Alternately, the beam of light 341 can be split into one or more additional beams of light using, for example, a beam splitter, and the resultant multiple beams of light can then be simultaneously scanned over multiple mirrors in the mirror array 344."), configured to direct the portion of the beam of the photoactivating light to a photodiode (para. [0104]: “Generally, the dosimetry system(s) 1060 include sensors (e.g., cameras) to measure characteristics of the corneal tissue 2 (e.g., images indicating fluorescence activity).”; the sensor of para. [0104] is considered to be photodiode). However, Freiedman does not explicitly disclose a second beamsplitter (although, the examiner notes Friedman discloses one or more beam splitters in para. [0055], just not configured to direct fluorescent light to a second photodiode) configured to direct the fluorescent light from the cornea to the second photodiode.
Tedford discloses a second beamsplitter configured to direct the fluorescent light from the cornea to the second photodiode. (para. [0102]: "In at least some embodiments, the device contains sensors (for example, sensor 754 of FIG. 7) to monitor the spatial or temporal irradiance pattern delivered to the patient. The sensor may include an array of one or more photodiodes, a camera of appropriate wavelength and time sensitivity, or another sensor capable of measuring the spatial and temporal irradiance profile of the delivered therapy. The resulting “beam profile” may then be analyzed through software within to the device to determine specific characteristics of the delivered therapy, including one or more of the following: diameter (as defined by a relative encircled energy metric, or a relative intensity metric), uniformity, pulse frequency, total power, maximum intensity, etc.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Friedman to include an additional beam splitter configured to direct a portion of the photoactivating light to a second photodiode, as disclosed by Tedford. One of ordinary skill would recognize that modifying the system of Friedman to include the photodiode of Tedford would improve the accuracy of the light dosing in Friedman. It would be an obvious improvement to include a photodiode to measure power and improve dosing accuracy since Tedford discloses modulating the beam output of photoactivating light measured by a photodiode to achieve a desired dosage. It would have further been obvious to include an additional beam splitter since Tedford discloses using a beam splitter to direct light, and Friedman discloses that more than one beam splitter may be implemented.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman (US 20150265762 A1, "Friedman") in view of Smith (US 20160106311 A1).
Regarding claim 12, Friedman teaches the system of claim 10 (see 102 rejection above), wherein the fluorescent light includes auto-fluorescence from corneal tissue (para. [0104]: "Generally, the dosimetry system(s) 1060 include sensors (e.g., cameras) to measure characteristics of the corneal tissue 2 (e.g., images indicating fluorescence activity)") and exogenous fluorescence resulting from a degradation of the cross-linking agent (para. [0122] discloses a drop in fluorescent intensity due to degradation of the cross-linking agent; fluorescence from a cross-linking agent is an exogenous fluorescence); and a controller (feedback system and controller 1020) configured to determine spatial variations in relative rates of cross-linking consumption and cross- linking activity in the cornea based on changes in the first signal and the second signal provided by the photodiode as the spot of photoactivating light is scanned over the scan pattern (para. [0105]: "For example, the feedback system(s) can monitor observable factors influencing (or indicative of) the distribution of cross-linking agent or the progress of cross-linking activity within the corneal tissue 2. Generally, the feedback system(s) include sensors to measure characteristics of the corneal tissue 2, and outputs to convey signals indicative of the measured characteristics to the controller 1020."; para. [0109]: "In some embodiments, feedback information from the feedback system(s) and/or fluorescence dosimetry system(s) 1050 can then be used to develop a treatment plan or dynamically adjust a treatment plan that is suited to the monitored characteristics of the corneal tissue 2. The treatment plan can be characterized by one or more applications of the cross-linking agent 1032 to achieve desired distributions within the cornea 2 and one or more energy doses of the initiating element 1040 delivered via optical elements according to desired patterns (e.g., via a DMD device or a scanning mirror system) to controllably activate cross-linking in the corneal tissue 2."). However, Friedman does not explicitly disclose a control configured to: receive, from the photodiode, a first signal corresponding to the auto-fluorescence and a second signal corresponding to the exogenous fluorescence.
Smith, in the same field of endeavor of ophthalmic treatment devices, discloses a fluorescent imaging system for imaging fluorophores in the eye. Smith discloses a controller configured to: receive, from the photodiode, a first signal corresponding to the auto-fluorescence and a second signal corresponding to the exogenous fluorescence (para. [0030]: "Upon excitation with different wavelengths of light, biological tissues emit distinct but related autofluorescence signals."; para. [0033] discloses analysis of autofluorescence signals sent to a controller in processing arrangement 16 for controlling the light source; paras [0046]-[0049] disclose signal decomposition to identify the intensity for two distinct signals, and the intensity would indicate concentration of endogenous fluorophores; the hyperspectral sensors would be a photodiode since it records light; para. [0073] discloses decomposing the signal to determine corresponding endogenous and exogenous fluorophores: “Although the above-described exemplary embodiments are described with respect to fluorescent imaging of fluorophors in an eye, those skilled in the art will understand that the methods and systems described herein may also be applicable to fluorescent imaging of any mixture of fluorophores in a biochemical system, including any type of tissue or biological source that provides autofluorescence, i.e., endogenous fluorescence, or that may be labelled with an exogenous fluorescent material or marker.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Friedman to include a controller that receives distinct auto-florescence and exogenous signals, as disclosed by Smith. One of ordinary skill in the art would recognize that the signals from an exogenous and endogenous florescence could compared to a reference material to determine the concentration, amount, and distribution of fluorophores present in a biochemical system (see Smith para. [0073]). It would have been an obvious improvement modify the system of Friedman to include the controller of Smith since it would improve the system’s ability to determine where cross-linking agent is applied.
Regarding claim 13, Friedman, in combination with Smith, discloses the system of claim 12 (see above). Friedman further discloses wherein, in response to the spatial variations, the light source is operable to adjust a power associated with the beam (para. [0062]-[0067]: " The two dimensional intensity pattern of the light pattern 345 is generated by the mirror array 344 according to, for example, the length of time that the beam of light 341 is scanned over each mirror in the mirror array 344. In particular, the light pattern 345 can be considered a pixilated intensity pattern with each pixel represented by a mirror in the mirror array 344 and the intensity of the light in each pixel of the light pattern 345 proportionate to the length of time the beam of light 341 scans over the mirror in the mirror array 344 corresponding to each pixel…Some embodiments may employ Digital Micromirror Device (DMD) technology to modulate the application of initiating light, e.g., UV light, spatially as well as temporally. Using DMD technology, a controlled light source is selectively reflected to provide the initiating light in a precise spatial pattern that is created by microscopically small mirrors laid out in a matrix on a semiconductor chip, known as a DMD. Each mirror represents one or more pixels in the pattern of reflected light. The power and duration at which the light is reflected to provide the pixelated intensity pattern is determined as described elsewhere. Alternatively, some embodiments may employ a scanning mirror system to apply the patterns of initiating light."), the one or more optical elements is operable to adjust a size of the spot of the photoactivating light produced by the beam (para. [0054]: "By controlling aspects of the operation of the optical elements 112 and the applicator 132, the controller 120 can control the regions of the cornea 2 that receive the cross-linking agent 130 and that are exposed to the light source 110. By controlling the regions of the cornea 2 that receive the cross-linking agent 130 and the light source 110, the controller 120 can control the particular regions of the cornea 2 that are strengthened and stabilized through cross-linking of the corneal collagen fibrils."; para. [0055]: " The optical elements 112 can be used to focus the light emitted by the light source 110 to a particular focal plane within the cornea 2, such as a focal plane that includes the mid-depth region 2B. In addition, according to particular embodiments, the optical elements 112 may include one or more beam splitters for dividing a beam of light emitted by the light source 110"), and/or the scanning system is operable to adjust a speed of the spot of the photoactivating light over portions of the scan pattern (para. [0062]: "By rapidly scanning the beam of light 341 over the mirrors in the mirror array 344, the mirror array 344 outputs a light pattern 345, which has a two dimensional intensity pattern. The two dimensional intensity pattern of the light pattern 345 is generated by the mirror array 344 according to, for example, the length of time that the beam of light 341 is scanned over each mirror in the mirror array 344. In particular, the light pattern 345 can be considered a pixilated intensity pattern with each pixel represented by a mirror in the mirror array 344 and the intensity of the light in each pixel of the light pattern 345 proportionate to the length of time the beam of light 341 scans over the mirror in the mirror array 344 corresponding to each pixel.").
Conclusion
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/O.L.M./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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