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 .
Response to Amendment
This Office action is in response to the communication filed 9/15/2026.
The Amendments to Claims 1, 4, and 6, filed 9/15/2026, are acknowledged and accepted.
The Cancellation of Claims 3, 5, and 20-25, filed 9/15/2026, are acknowledged and accepted.
Newly submitted Claims 31-37, filed 9/15/2026, are acknowledged and accepted.
The 112 rejection of claims 5 and 20 has been withdrawn.
Response to Arguments
Applicant's arguments filed 9/15/2026 have been fully considered but they are not persuasive. Applicant argues that Andrews teaches a method of detecting corneal astigmatism using OCT-derived corneal topography, including determining refractive power and meridian axes from measurements of the cornea. Andrews does not disclose producing a corneal augmentation, determining the shape of a corneal augmentation, or using a corneal map to determine the three- dimensional geometry of donor corneal tissue. Nor does Muller provide a reason to repurpose Andrews's diagnostic information in that manner. Muller concerns forming corneal implants and determining a shape intended to provide a desired refractive result, but does not teach using a corneal map as the basis for determining that implant shape. Neither reference provides a reason to use Andrews's diagnostic output as design input for determining the three-dimensional geometry of Muller's implant. Although an express teaching to combine is not required, an obviousness rejection must still identify "a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR Int'l Co. V. Teleflex Inc., 550 U.S. 398, 418 (2007). Thus, it would not have been obvious to combine Muller and Andrews. It has been well established that to be useful in an obviousness combination, a secondary reference should be used for what it teaches and need not be bodily substituted into the primary reference structure. “Question in a rejection for obviousness on a combination of references is what secondary reference would teach one skilled in the art and not whether its structure could be bodily substituted in basic reference structure.” In re Richman 165 USPQ 509 (CCPA 1970).The MPEP (2131.05 [R-5] Nonanalogous > or Disparaging Prior < Art, states (The question of whether a reference is analogous art is not relevent to whether that reference anticipates. A reference may be directed to an entirely different problem than addressed by the inventor, or may be from an entirely different field of endeavor than that of the claimed invention, yet the reference is still anticipatory if it explicitly or inherently discloses every limitation recited in the claims). Thus the rejection is maintained.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 4, 6-19, and 26-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. (2017/0319329), hereinafter Muller in view of Andrews et al. (WO 2015044364), hereinafter Andrews.
Regarding claim 1, Muller discloses a device for amelioration of an abnormality of a cornea (paragraphs 0029 and 0031), the device comprising: a corneal augmentation (10, corneal implant) produced from a corneal template comprised of corneal tissue (paragraph 0032), the corneal template being comprised of corneal tissue from a source other than the cornea (paragraph 0032), wherein the corneal augmentation has a three-dimensional shape (paragraph 0032) formed by a cutting tool based on a cutting file (paragraphs 0061 and 0062).
Moreover, the further limitations of claim 1 are directed to method steps of making the device, and it could have been made using an alternative method such as cryo-microtome or a femtosecond laser. The method limitations are not germane to patentability pursuant to MPEP §2112.02, since it has been held that “'[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.' In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).”
Muller does not specifically disclose wherein the three-dimensional shape is determined based on a corneal map of the cornea.
Muller and Andrews both disclose systems for corneal implants.
Andrews discloses wherein the three-dimensional shape is determined based on a corneal map of the cornea (paragraph 9 discloses a three-dimensional map of the cornea and paragraph 10 discloses corneal tomography).
Therefore it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Muller with the corneal map of Andrews for the purpose of determining the shape, curvature, and thickness of the cornea.
Regarding claim 2, Muller discloses wherein the abnormality of the cornea is keratoconus (paragraph 0056).
Regarding claim 4, Andrews discloses wherein the corneal map is obtained using corneal tomography or corneal topography (paragraph 9 discloses a three-dimensional map of the cornea and paragraph 10 discloses imaging corneal tomography).
Regarding claim 6, Andrews discloses wherein the corneal map is an elevation map (paragraph 9 discloses a three dimensional map of the cornea and paragraph 19 discloses OCT scans to show topographic images; and topography images show elevation).
Regarding claim 7, Muller discloses wherein the three-dimensional shape has a non-uniform cross-section (paragraphs 0032-0033).
Regarding claim 8, Muller discloses wherein the three-dimensional shape is arcuately shaped (paragraph 0033).
Regarding claim 9, Muller discloses wherein the three-dimensional shape has a uniform thickness (paragraph 0063).
Regarding claim 10, Muller discloses wherein the uniform thickness is based on a measured shape of the cornea (paragraphs 0061 and 0063).
Regarding claim 11, Muller discloses wherein the uniform thickness is about 0.1 mm to about 0.5 mm (paragraphs 0061 and 0063).
Regarding claim 12, Muller discloses wherein the three-dimensional shape is a sector of a doughnut shape (paragraphs 0032-0033).
Regarding claim 13, Muller discloses wherein the sector of the doughnut shape has a uniform thickness (paragraphs 0032-0033).
Regarding claim 14, Muller discloses wherein the uniform thickness is based on a measured shape of the cornea (paragraphs 0063-0064).
Regarding claim 15, Muller discloses wherein the uniform thickness is about 0.1 mm to about 0.5 mm (paragraphs 0061 and 0063).
Regarding claim 16, Muller discloses wherein the sector of the doughnut shape has a non-uniform cross-section (paragraphs 0032-0033).
Regarding claim 17, Muller discloses all the limitations in common with claim 1, and such is hereby incorporated. Muller further discloses wherein the doughnut shape has an inner radius (see figure 1B)
Muller does not specifically disclose wherein the doughnut shape has an inner radius of about 3 mm to about 5 mm.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have a doughnut shape having an inner radius of about 3 mm to about 5 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, In re Aller, 105 USPQ 233 (C.C.P.A. 1955). This being reasonably based upon helping to flatten the central cornea, improving visual acuity and reducing irregular astigmatism.
Regarding claim 18, Muller discloses all the limitations in common with claim 1, and such is hereby incorporated. Muller further discloses wherein the doughnut shape has an outer radius (see figure 1B)
Muller does not specifically disclose wherein the doughnut shape has an outer radius of about 7 mm to about 9 mm.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have a doughnut shape having an outer radius of about 7 mm to about 9 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, In re Aller, 105 USPQ 233 (C.C.P.A. 1955). This being reasonably based upon helping to flatten the central cornea, improving visual acuity and corneal stability.
Regarding claim 19, Muller discloses wherein the three-dimensional shape has a thickness proportional to a maximum keratometry of the cornea (paragraph 0056).
Regarding claim 26, Muller discloses wherein the three-dimensional shape has a plan projection that is one of a polygon, a lenticule, a doughnut, a crescent, and an arc (paragraph 0033).
Regarding claim 27, Muller discloses wherein the three-dimensional shape has a tapered edge (paragraph 0043).
Regarding claim 28, Muller discloses wherein the three-dimensional shape has one or more lateral cuts to form corneal segments (paragraph 0075).
Regarding claim 29, Muller discloses wherein the corneal segments have a required arc length (figures 5 and 13C).
Regarding claim 30, Muller discloses wherein the three-dimensional shape has a rectangular cross-section (figure 1A).
Regarding claim 31, Andrews discloses wherein the corneal map of the cornea comprises a quantified deviation of the cornea from an optimal corneal shape (paragraph 9 discloses the curvature distribution can now be calculated from the deviation of these ring images from the ideal circular shape and a three-dimensional "map" of the cornea can be determined by conversion of the measurement data.)
Regarding claim 32, Muller discloses wherein the cutting tool is configured to produce the corneal augmentation having the three-dimensional shape (paragraphs 0005-007 and 0062).
Regarding claim 33, Muller discloses wherein the cutting tool is a laser (paragraphs 0035 and 0044).
Regarding claim 34, Muller discloses wherein the laser is a femtosecond laser (paragraph 0035).
Regarding claim 35, Muller discloses wherein the three-dimensional shape of the corneal augmentation is further formed by a second cutting tool, the second cutting tool being configured to reshape the corneal augmentation (paragraphs 0035, 0044, and 0062-0063).
Regarding claim 36, Muller discloses wherein the second cutting tool is a laser (paragraph 0035).
Regarding claim 37, Muller discloses wherein the laser is an excimer laser (paragraph 0096).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDI N THOMAS whose telephone number is (571)272-2341. The examiner can normally be reached Monday - Friday 7:30 - 3:30.
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/BRANDI N THOMAS/Primary Examiner, Art Unit 2872
