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
Acknowledgement is made of receipt of Information Disclosure Statement(s) (PTO-1449) filed 12/26/2025 and 4/6/2026. An initialed copy is attached to this Office Action.
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 5 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.
A claim to a device, apparatus, manufacture, or composition of matter may contain a reference to the process in which it is intended to be used without being objectionable, so long as it is clear that the claim is directed to the product and not the process. Claim 5 clearly discloses the process of selecting a three-dimensional shape of the corneal augmentation and is therefore claiming the process and not the product itself. Claim 20 discloses the process of producing the three-dimensional shape and is therefore claiming the process and not the product itself.
Claims 21-25 are dependent from claim 20 and are also rejected.
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.
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.
Claim(s) 1-2, 7-16, 19, and 26-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muller et al. (2017/0319329), hereinafter Muller.
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).”
Regarding claim 2, Muller discloses wherein the abnormality of the cornea is keratoconus (paragraph 0056).
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 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).
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) 3-4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. (2017/0319329), hereinafter Muller as applied to claim 1 above, and further in view of Andrews et al. (WO 2015044364), hereinafter Andrews.
Regarding claim 3, Muller discloses all the limitations in common with claim 1, and such is hereby incorporated.
Muller does not specifically disclose wherein the three-dimensional shape is determined based on a corneal map of the cornea.
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 imaging 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 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).
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. (2017/0319329), hereinafter Muller.
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.
Conclusion
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
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