DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The IDS submitted on 01/29/2026 is being considered by the examiner.
Drawings
The drawings received on 01/25/2025 are not acceptable due to Figure 5 being a colored drawing.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
The drawings received on 03/31/2025 are acceptable.
Claim Objections
Claim 9, 16, and 23-24 are objected to because of the following informalities:
Claim 9, line 2 reads "first volume of tissue and for application of laser energy". For clarity, examiner suggests "first volume of tissue or for application of laser energy" should it meet the expected scope of the claim.
Claim 16, line 1 reads “method of 15” should read “method of claim 15”.
Claim 23, line 1 reads “the region” should read “the region of interest”.
Claim 24, line 1 reads “method of any claim 20” should read “method of claim 20”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 11, 15-16, 21-22, and 24 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.
Claim 11 recites the limitation "total time" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "lamina cribrosa" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "tissue" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 21 and 22 recite the limitation "collagenous tissue" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation “laser energy” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 4-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peyman (US 20100210996 A1).
Regarding claim 1, Peyman teaches a method of modifying biomechanical properties of tissue in a region of interest (abstract (a method of altering the refractive properties of the eye), para. 0160 (by performing the cross linker before or after ablation of the cornea (or other method altering the refractive properties of the eye) the cornea becomes stiffer)) comprising:
application of laser energy to one or more first volumes of tissue in the region of interest to cause softening via photodegradation (para. 0095 (laser 500 is preferably fired at a portion 506 of the cornea beneath or under the exterior surface 24 of the cornea, forming a predetermined pattern of cavities), 0070 (By heating the corneal stroma to about or below 60 degree C., the molecules of the cornea are loosened, and the cornea changes from a substantially solid substance to a gelatinous substance or gel-like substance))); and
application of laser energy to one or more second volumes of tissue within the region of interest to cause stiffening via photocrosslinking, the one or more second volumes are different from the one or more first volume (para. 0100 (laser or light emitting device 512 is aimed and fired at the corneal stroma, at or approximately at the portion of the cornea in which the cavities 502 are formed…laser beam L (preferably combined with the reaction from photosensitizer 508) then heats the corneal stroma to… facilitate cross-linking of the collagen cells in the eye), 0152 (cornea is cross linked to stiffen the cornea)).
Regarding claim 2, Peyman teaches the method of claim 1 further comprising determining modifications of the biomechanical properties of the tissue in the region of interest and determining the one or more first volumes of tissue and the one or more second volumes of tissue to achieve the determined modifications prior to application of laser energy to the one or more first volumes of tissue and application of laser energy to one or more second volumes of tissue (para. 0093 (the refractive error in the eye is measured using wavefront technology, as is known to one of ordinary skill in the art or any other suitable method. The refractive error measurements are used to determine the appropriate shape of lens or contact 504 to best correct the error in the patient's cornea)).
Regarding claim 4, Peyman teaches the method of claim 1 wherein the one or more first volumes of tissue comprises collagen (para. 0095 (cornea, cornea comprises collagen)) and the one or more second volumes of tissue comprises collagen (para. 0100 (cross-linking of the collagen cells in the eye)).
Regarding claim 5, Peyman teaches the method of claim 4 wherein a first laser is used to apply laser energy to the one or more first volumes of tissue (para. 0095 (laser 500 forms a predetermined pattern of cavities)) and a second laser is used to apply laser energy to the one or more second volumes of tissue (para. 0100 (laser 512 is aimed… at or approximately at the portion of the cornea in which the cavities 502 are formed… Laser 512 can be… a substantially similar laser, as laser 500)).
Regarding claim 6, Peyman teaches the method of claim 4 wherein a single laser is used to apply laser energy to the one or more first volumes of tissue and to the one or more second volumes of the tissue (para. 0100 (Laser 512 can be the same laser… as laser 500)).
Regarding claim 7, Peyman teaches the method of claim 1 wherein the biomechanical properties of the tissue are modified through thermoacoustic effects or through photochemical effects (para. 0062 (flap may be formed in the stromal layer of the cornea… may be formed by any means desired, such as with a knife or laser), 0098 (photosensitizer… can absorb ultraviolet or near ultraviolet radiation to help facilitate or create cross-linking of collagen and hold the corneal structure into the new reformed shape… [and] is capable of initiating or catalyzing the energy from the laser 500), 0100 (Laser 512… can by any device capable of emitting ultraviolet light radiation)).
Regarding claim 8, Peyman teaches the method of claim 1 wherein the biomechanical properties of the tissue are modified in the absence of thermoacoustic effects (para. 0096 (Laser 500 is preferably an ultra short pulse laser, such as a femto, pico, or attosecond laser), 0068 (laser beam is in the infrared portion of the electromagnetic spectrum)).
Regarding claim 9, Peyman teaches the method of claim 1 wherein a femtosecond laser is used for at least one of application of laser energy to the one or more first volumes of tissue and for application of laser energy to the one or more second volumes of tissue (para. 0095 (Laser 500 is preferably an ultra short pulse laser, such as a femto, pico, or attosecond laser)).
Regarding claim 10, Peyman teaches the method of claim 1 wherein a femtosecond laser is used for application of laser energy to the one or more first volumes of tissue and for application of laser energy to the one or more second volumes tissue (para. 0095 (Laser 500 is preferably an ultra short pulse laser, such as a femto, pico, or attosecond laser), 0100 (Laser 512 can be the same laser… as laser 500)).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman and in view of Vukelic et al. (US 11559433 B2), hereinafter Vukelic.
Regarding claim 3, Peyman teaches the method of claim 2. Peyman does not disclose creating a biomechanical index or map of the region of interest before application of laser energy to the one or more first volumes of tissue and before application of laser energy to the one or more second volumes of tissue.
Vukelic teaches creating a biomechanical index or map of the region of interest before application of laser energy to the one or more first volumes of tissue and before application of laser energy to the one or more second volumes of tissue (col. 2, lines 52-64 ([system] can convert the pattern reflection to a corneal topography, and configured to compare the corneal topography to a desired corneal topography to determine a deformation map 302… the laser system is configured to induce cross-linking of collagen in the cornea according to the deformation map), col. 6, lines 19-25 (method can include mapping the topography of the patient's eye prior to treatment and designing a pattern of exposure based on that topography)).
Peyman and Vukelic are considered to be analogous to the claimed invention because they are in the same field of inducing cross-linking in eye tissue. Although Peyman discloses taking measurements of the eye before applying laser energy, to create an appropriate lens for the surgery, Peyman does not teach creating a map (para. 0093). However, Vukelic teaches creating a topographic map of the eye before treatment, for a desired corneal topography, and applying cross linking based on the map (col. 2 lines 52-64). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peyman to incorporate the teachings of Vukelic listed, and provide a map of the region of interest before application of laser energy to the first and second volumes of tissue. Doing so would improve Peyman’s method of treatment, by being able to follow the map to the section of interest, thereby improving the accuracy of the application of laser energy.
Regarding claim 19, Peyman (in view of Vukelic) teaches the method of claim 3 wherein the region of interest is tissue of the eye (para. 0093 (the refractive error in the eye is measured)).
Peyman does not disclose creating the biomechanic index comprising comparison of images created at different pressures within the eye, wherein the different pressures are created either intrinsically or extrinsically.
Vukelic discloses creating the biomechanic index comprising comparison of images created at different pressures within the eye, wherein the different pressures are created either intrinsically or extrinsically (Fig.s 11-12, para. 0085 (digital image correlation (DIC) system was employed to acquire spatially and time resolved displacement maps of the corneal surface), 0086 (examples of deformation maps at various pressures)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peyman to incorporate the biomechanic index taught by Vukelic. Doing so improves Peyman’s method by using representative methodology that enables the assessment of the deformation of the eye in response to pressure, which further improves planning the region of interest, by tracking the deformations when reshaping the cornea.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman and in view of Wevill (https://crstodayeurope.com/topics/general/what-is-the-ideal-femtosecond-laserfor-lasik/47410/), and in further view of Alonso-Aliste et al. (https://www.mdpi.com/2673-3269/2/1/6), hereinafter Alonso.
Regarding claim 11, Peyman teaches the method of claim 10. Peyman does not disclose wherein the total time of application of laser energy to each of the one or more first volumes of tissue is less that the total time of application of laser energy to each of the one or more second volumes of tissue.
Wevill discloses multiple types of femtosecond lasers with an approximate flap cut times, with the highest time being 22 seconds (pg. 2).
Alonso discloses corneal cross linking with a photosensitizer with an irradiation time of 90 seconds (pg. 3).
Peyman, Wevill, and Alonso are all considered to be analogous to the claimed invention because they are in the same field of using lasers in eye tissue for vision treatment. Peyman discloses creating a flap, but does not disclose the duration of the laser (para. 0062). However, Wevill discloses that creating a flap with a femtosecond laser can range from 7 to 22 seconds (pg. 2). Peyman also discloses using a sensitizer to perform cross linking in the cornea stroma, with the application of laser energy, but also does not disclose the duration of the laser (para. 0100). However, Alonso also discloses cross linking within the cornea stroma with the application of a photosensitizer and laser, with a duration of 90 seconds (pg. 3).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peyman to incorporate the combination of teachings listed, to show that the application of laser energy to the first volume of tissues is less total time than the application of energy to the second volume of tissues. A person of ordinary skill in the art would be motivated to teach the time of the laser duration within the method of the applications of laser energy, to correct the refractive properties of the eye safely and effectively.
Regarding claim 12, Peyman (in view of Wevill and Alonso) teaches the method of claim 11, wherein each of the one or more first volumes of tissue and each of the one or more second volumes of tissue is tissue of the eye (para. 0018 (facilitate cross linking of the cornea, irradiating the cornea so as to activate cross linkers in the cornea, and altering the cornea so as to change the refractive properties of the eye)).
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman in view of Wevill and in further view of Alonso and Herekar et al. (US 20140276361 A1), hereinafter Herekar.
Regarding claims 13 and 14, Peyman (in view of Wevill and Alonso) teaches the method of claim 12, and the one or more first volumes of tissue and the one or more second volumes of tissue is tissue of the eye (para. 0018 (facilitate cross linking of the cornea)).
Peyman does not teach the eye tissue being tissue of the trabecular meshwork, Schlemm's canal, the episclera, the sclera or tissue of the lamina cribrosa.
Herekar teaches tissue of the trabecular meshwork, Schlemm's canal, the episclera, the sclera or tissue of the lamina cribrosa (para. 0041 (laser system 422 may require a slower lens system that allows proper focusing on the target eye tissue 2, particularly, the lamina cribrosa and/or peripapillary sclera)).
Peyman teaches directing applying laser energy to the cornea, but could also be directed at a suitable portion of the eye (para. 0092). Herekar teaches a laser system employing multiphoton excitation to activate the cross-linking agent to penetrate the target eye tissue, particularly the lamina cribrosa and/or peripaillary sclera (Herekar, para. 0041-0042).
Peyman, Wevill, Alonso, and Herekar are all considered to be analogous to the claimed invention because they are in the same field of applying laser energy in eye tissue for treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peyman to incorporate the teachings of Herekar listed, and have the tissues of treatment be the lamina cribrosa. Peyman and Herekar disclose inducing cross linking activity within the collagen of the eye tissue, to stabilize and improve its biomechanical strength. It would have been obvious for Peyman’s laser to focus on the lamina cribrosa instead of the cornea, as it will yield predictable results, as taught by Herekar.
Regarding claim 15, Peyman (in view of Wevill and Alonso) teaches the method of claim 11. Peyman does not disclose wherein each of the one or more first volumes of tissue and each of the one or more second volumes of tissue are located on one or more beams of the lamina cribrosa which do not include a blood vessel.
Herekar teaches tissue of the lamina cribrosa (para. 0041 (laser system 422 may require a slower lens system that allows proper focusing on the target eye tissue 2, particularly, the lamina cribrosa and/or peripapillary sclera)).
Although Herekar does not explicitly disclose the tissue being located on one or more beams of the lamina cribrosa that do not include a blood vessel, it’s rendered obvious to direct the treatment to a beam that does not contain a blood vessel. A person of ordinary skill in the art would have been motivated to avoid directing laser energy at blood vessels within the lamina cribrosa, to reduce the risk of vascular damage and possible eye complications.
Regarding claim 16, Peyman (in view of Wevill, Alonso, and Herekar) teaches the method of 15. Peyman does not disclose wherein the biomechanical properties of the tissue are modified to treat glaucoma or to prevent glaucoma.
Hereker teaches modifying biomechanical properties of the tissue are modified to treat glaucoma or to prevent glaucoma (para. 0019 (methods for generating cross-linking activity in areas of the eye, such as the lamina cribrosa and/or peripapillary sclera, to treat glaucoma), 0023 (Cross-linking of collagen fibers in the lamina cribrosa and/or peripapillary sclera modulates biomechanical stress and strain-based injury mechanisms in the laminar region toward the goal of preventing the onset or slowing the progression of glaucomatous optic neuropathy)).
Peyman teaches a method of altering the refractive properties of the eye using laser treatment to the cornea (para. 0018). Herekar teaches a laser system to generate cross linking activity within the eye tissue. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peyman to incorporate the teachings of Herekar listed, and have the focus of the treatment be towards treating glaucoma. Doing so merely involves the alteration of ocular properties of Peyman, for the known purpose of preventing glaucoma, yielding the predictable result as taught by Herekar.
Claims 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman and in view of Herekar
Regarding claim 20, Peyman teaches a method comprising softening tissue in a region of interest in the eye (para. 0095 (laser 500 is preferably fired at a portion 506 of the cornea beneath or under the exterior surface 24 of the cornea, forming a predetermined pattern of cavities)).
Peyman does not teach method being used for treating or preventing glaucoma.
Herekar teaches a method of treating or preventing glaucoma in a region of interest in the eye (para. 0019 (methods for generating cross-linking activity in areas of the eye, such as the lamina cribrosa and/or peripapillary sclera, to treat glaucoma), 0023 (Cross-linking of collagen fibers in the lamina cribrosa and/or peripapillary sclera modulates biomechanical stress and strain-based injury mechanisms in the laminar region toward the goal of preventing the onset or slowing the progression of glaucomatous optic neuropathy)).
Peyman teaches a method of altering the refractive properties of the eye using laser treatment to the cornea (para. 0018). Herekar teaches a laser system to generate cross linking activity within the eye tissue. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peyman to incorporate the teachings of Herekar listed, and have the focus of the treatment be towards treating glaucoma. Doing so merely involves the alteration of ocular properties of Peyman, for the known purpose of preventing glaucoma, yielding the predictable result as taught by Herekar.
Regarding claims 21 and 22, Peyman (in view of Herekar) teaches the method of claim 20, and collagenous tissue of the eye (para. 0100 (cross-linking of the collagen cells in the eye)).
Peyman does not teach wherein the collagenous tissue is at least one of the trabecular meshwork, Schlemm's canal, the episclera, the sclera and the lamina cribrosa.
Herekar teaches wherein the collagenous tissue is at least one of the trabecular meshwork, Schlemm's canal, the episclera, the sclera or tissue of the lamina cribrosa (para. 0041 (laser system 422 may require a slower lens system that allows proper focusing on the target eye tissue 2, particularly, the lamina cribrosa and/or peripapillary sclera)).
Peyman teaches directing applying laser energy to the cornea, but could also be directed at a suitable portion of the eye (para. 0092). Herekar teaches a laser system employing multiphoton excitation to activate the cross-linking agent to penetrate the target eye tissue, particularly the lamina cribrosa and/or peripaillary sclera (Herekar, para. 0041-0042).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peyman to incorporate the teachings of Herekar listed, and have the tissues of treatment be the lamina cribrosa. Peyman and Herekar disclose inducing cross linking activity within the collagen of the eye tissue, to stabilize and improve its biomechanical strength. It would have been obvious for Peyman’s laser to focus on the lamina cribrosa instead of the cornea, as it will yield predictable results, as taught by Herekar.
Regarding claim 23, Peyman (in view of Herekar) teaches the method of claim 20, wherein the tissue in the region is softened via the application of laser energy (para. 0095 (laser 500 is preferably fired at a portion 506 of the cornea beneath or under the exterior surface 24 of the cornea, forming a predetermined pattern of cavities), 0070 (By heating the corneal stroma to about or below 60 degree C., the molecules of the cornea are loosened, and the cornea changes from a substantially solid substance to a gelatinous substance or gel-like substance)));
Regarding claim 24, Peyman (in view of Herekar) teaches the method of claim 20, further comprising applying the laser energy to one or more second volumes of collagenous tissue of the eye to cause stiffening in the region of interest, the one or more second volumes being different from the one or more first volumes (para. 0100 (laser or light emitting device 512 is aimed and fired at the corneal stroma, at or approximately at the portion of the cornea in which the cavities 502 are formed…laser beam L (preferably combined with the reaction from photosensitizer 508) then heats the corneal stroma to… facilitate cross-linking of the collagen cells in the eye), 0152 (cornea is cross linked to stiffen the cornea)).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman and in view of Dubois (US 20160320598 A1).
Regarding claims 17 and 18, Peyman teaches the method of claim 10, and the laser energy applied to the one or more first volumes of tissue energy (para. 0095 (laser 500 is preferably fired at a portion 506 of the cornea beneath or under the exterior surface 24 of the cornea, forming a predetermined pattern of cavities)) and the laser energy applied to the one or more second volumes of tissue (para. 0100 (laser or light emitting device 512 is aimed and fired at the corneal stroma, at or approximately at the portion of the cornea in which the cavities 502 are formed)).
Peyman does not teach wherein the laser energy has an axial resolution of not more than 40 μm, not more than 30 μm, not more than 20 μm, or not more than 10 μm and a lateral resolution of not more than 40 μm, not more than 30 μm, not more than 20 μm, or not more than μm.
Dubois discloses axial resolution of not more than 40 μm, not more than 30 μm, not more than 20 μm, or not more than 10 μm (para. 0013 (the axial resolution achieved is approximately 3 μm … by using a very costly femtosecond pulsed laser as light source)) and a lateral resolution of not more than 40 μm, not more than 30 μm, not more than 20 μm, or not more than 10 μm (para. 0013 (the lateral resolution approximately 2 μm, these results being obtained by using a very costly femtosecond pulsed laser as light source)).
Peyman and Dubois are considered to be analogous to the claimed invention because they are in the same field of scanning eye tissue with a femtosecond laser. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peyman to incorporate the teachings of Dubois and provide the axial and lateral resolution. Doing so would optimize Peyman’s method in modifying refractive properties of the eye, by including the axial and lateral resolution, to ensure that the laser energy is applied to the cornea within the selected region of interest.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Muller et al. (US 20120289886 A1) and Friedman et al. (US 20190192840 A1) are additional examples of laser treatment systems using an excimer laser for collagen cross linking.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EILEEN ROBLES whose telephone number is (571)429-9383. The examiner can normally be reached Monday-Friday: 8:00 - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EILEEN ROBLES/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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