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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/23/26 has been entered.
Response to Amendment
This action is entered in response to Applicant's Amendment and Reply of 1/23/26. Claims 27, 40, 42 have been amended. Claims 27, 28, 30-56 are pending. Claims 45-56 are withdrawn.
Response to Arguments
Applicant’s arguments, filed 1/23/26, with respect to the rejections of claims 27, 28, 30, 35-37, 40-42, 44 under 35 U.S.C. 102(a)(1) as being anticipated by Christie (US2006/0271177) (Christie-2). have been fully considered but are not persuasive.
Applicant argues, the independent claims 27, 40, and 42 have been amended to recite the limitations “a dimensionally stable lattice structured, sized and shaped to be implanted into the cornea that is dimensionally stable in a deployed state when implant within the cornea”. Applicant argues, the physical holes in Christie cannot be considered to represent a lattice structure as described and claimed according to the claimed invention. Examiner disagrees, as previously stated, Christie discloses a lattice structure by having holes arranged in a hex pattern as described in paragraph [0247]. Where this pattern would be similar to a bee’s nest and would be considered a web given the broadest reasonable interpretation consistent with the specification. Applicant relies on paragraph [0003] of the published application, stating there is a distinction between the claimed invention and the prior art because the distances separating the holes in Christie are not webs. Examiner disagrees, the device of Christie includes the same structural features as recited in the claimed invention, there is no specific limitations of the sizing or spacing of the holes claimed and furthermore, the holes of Christie can perform the functional recitations of having the cells move through the implant. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the sizing and spacing of the holes) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant questions whether cells would pass through the structure disclosed by Christie because it differs so much from the natural cornea. Examiner states, the device of Christie is structurally the same as the claimed invention and therefore would perform the functions recited. Applicant’s arguments of the structure of Christie might trigger an immune reaction are unfounded. Nothing in Christie states the device would trigger an immune reaction. Instead, Christie teaches a desire to prevent an immune reaction by being intended to be implanted in the cornea to restore vision (see [0103]).
Furthermore, Applicant argues, dimensional stability is not taught by Christie. Examiner disagrees, as stated in the previous rejection, the mask being dimensionally stable by being pre-rolled for ease in implantation ([0167]). Since the mask is first rolled or folded and subsequently deployed within the eye to correct vision, it is dimensionally stable by being able to be manipulated for delivering and returning to a state for being implanted without comprising the structure ([0167]). Furthermore, the internal structure would allow for it to be dimensionally stable by the hexagonal arrangement of the holes ([0247]).
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.
Claims 27, 28, 30, 35-37, 40-42, and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Christie (US2006/0271177) (Christie-2).
Regarding claim 27, Christie-2 discloses an intraocular corneal implant for implantation in a cornea ([0102]), the intraocular corneal implant comprising:
a dimensionally stable lattice structure (the mask is interpreted as a dimensionally stable lattice structure by the holes being arranged in a hex pattern, [0247]; and the mask being dimensionally stable by being pre-rolled for ease in implantation, [0167]) that is dimensionally stable in a deployed state when implanted within the cornea ([0009]) and that is structured, sized and shaped to be implanted into the cornea ([0244]), the dimensionally stable lattice structure having a stable but elastic internal lattice structure (interpreted as having an elastic internal structure in line with the specification page 5, lines 9-10 “more or less a regular inner structure” by having a hex pattern internal structure that can be rolled and releases to a deployed shape, [0167], [0247]), the dimensionally stable lattice structure further being adapted to permit permeability for small molecules when implanted in the cornea, adapted to support the mobility of endogenous cells in and through the implant or both ([0246]);
the dimensionally stable lattice structure having a microscopically irregular framework structure thereby to mitigate diffraction effects when implanted into the cornea ([0244]); and
wherein the dimensionally stable lattice structure defines channels with a diameter of> 1 gm and webs with a dimension of < 50 pm (holes are dimension with a diameter of about 0.015 mm/15 um or more, [0265]).
Regarding claim 28, Christie-2 discloses the intraocular implant as claimed in claim 27, the lattice structure further supports the mobility of endogenous cells to colonize the implant (see claim 1, [0264]).
Regarding claim 30, Christie-2 discloses the intraocular implant as claimed in claim 27, wherein the channels have a diameter of > 3 micrometers, and the webs have a dimension of < 20 micrometers (holes are dimension with a diameter of about 0.015 mm/15 um or more, [0265]).
Regarding claim 35, Christie-2 discloses the intraocular implant as claimed in claim 27, wherein the intraocular implant is adapted for a preferential direction for cell movement ([0264]).
Regarding claim 36, Christie-2 discloses the intraocular implant as claimed in claim 27; in which mechanical properties, optical properties or both of the implant vary spatially (see claim 1, [0264]).
Regarding claim 37, Christie-2 discloses the intraocular implant as claimed in claim 27, at least one of the following is true:
the material is configured such that the implant has an additional optical function ([0250]);
the material is configured such that a diffractive optical element is present ([0244]);
the material is configured such that part of the visible light is absorbed ([0259]);
the material is configured such that the effective refractive power of the implant is such that the material generates a refractive effect on a surrounding eye structure ([0250]); and
the material is configured such that the effective refractive power of the implant is such that the material generates a refractive effect on the cornea ([0250]).
Regarding claim 44, Christie-2 discloses the intraocular implant as claimed claim 27, wherein the intraocular implant comprises an intraocular lens (IOL), an intraocular lens (IOL) carrier matrix or both ([0136]).
Regarding claim 40, Christie-2 discloses an intraocular corneal implant for implantation in a cornea ([0102]), the intraocular corneal implant comprising:
a dimensionally stable lattice structure (the mask is interpreted as a dimensionally stable lattice structure by the holes being arranged in a hex pattern, [0247]; and the mask being dimensionally stable by being pre-rolled for ease in implantation, [0167]) sized and shaped to be implanted into the cornea that is dimensionally stable in a deployed state when implanted within the cornea ([0009], [0244]), having a stable but elastic internal lattice structure (interpreted as having an elastic internal structure in line with the specification page 5, lines 9-10 “more or less a regular inner structure” by having a hex pattern internal structure that can be rolled and releases to a deployed shape, [0167], [0247]), the dimensionally stable lattice structure further being adapted to permit permeability for small molecules when implanted in the cornea, adapted to support the mobility of endogenous cells in the implant or both ([0246]);
the dimensionally stable lattice structure having a microscopically irregular framework structure to thereby mitigate diffraction effects when implanted in the cornea ([0244]) and wherein the dimensionally stable lattice structure defines channels with a diameter of> 1 um and webs with a dimension of < 50 um (holes are dimension with a diameter of about 0.015 mm/15 um or more, [0265]);
wherein the dimensionally stable lattice structure is filled with a liquid, or is adapted to be filled with a liquid (the openings formed through the mask would allow for liquid to fill the structure, [0247]), wherein the liquid remains stable in the lattice structure and is optically transparent (The Examiner notes “the liquid” is positively recited in the alternative only and therefore not required to be shown by the prior art, further the liquid is capable of being a transparent liquid).
Regarding claim 41, Christie-2 discloses the intraocular implant as claimed in claim 40, wherein the refractive index of the liquid is matched to the refractive index of the implant material (The Examiner notes “the liquid” is positively recited in the alternative only and therefore not required to be shown by the prior art; further the liquid is capable of matching the refractive index of the implant).
Regarding claim 42, Christie-2 discloses an intraocular implant for implantation in a cornea ([0102]), the intraocular implant comprising:
a dimensionally stable lattice structure (the mask is interpreted as a dimensionally stable lattice structure by the holes being arranged in a hex pattern, [0247]; and the mask being dimensionally stable by being pre-rolled for ease in implantation, [0167]) structured, sized and shaped to be implanted into the cornea that is dimensionally stable in a deployed state when implanted within the cornea ([0009], [0244]), having a stable but elastic internal lattice structure (interpreted as having an elastic internal structure in line with the specification page 5, lines 9-10 “more or less a regular inner structure” by having a hex pattern internal structure that can be rolled and releases to a deployed shape, [0167], [0247]), the dimensionally stable lattice structure further being adapted to permit permeability for small molecules when implanted into the cornea, adapted to support the mobility of endogenous cells in the implant or both ([0246]);
the dimensionally stable lattice structure having a microscopically irregular framework structure to thereby mitigate diffraction effects when implanted into the cornea (see claim 1, [0273]); and
wherein the dimensionally stable lattice structure defines channels with a diameter of > 1 um and webs with a dimension of < 50 um (holes are dimension with a diameter of about 0.015 mm/15 um or more, [0265]);
wherein the intraocular implant comprises a corneal implant that changes the outer shape of a cornea (the implant is capable of changing the outer shape of a cornea by the positioning of the mask in the eye, [0102]).
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 of this title, 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 31-34, 38, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Christie-2 (US2006/0271177) as applied to claim 27, and further in view of Bango (US2003/0232287).
Regarding claim 31, Christie-2 discloses the intraocular implant as claimed in claim 27; yet, is silent regarding wherein intraocular implant comprises a biocompatible material, which is arranged in the form of fibrils in lamellae in the lattice structure. Bango teaches properly prepared collagen thin films are those that have been etched to create a regular lattice structure consisting of horizontal and vertical fibril elements that are spaced apart ([0043]). It would have been obvious to one having ordinary skill in the art to have the intraocular implant comprise a biocompatible material, which is arranged in the form of fibrils in lamellae in the lattice structure as taught by Bango, since the method of creating a lattice structure with fibers in layers for replacement of an eye structure would be beneficial by mimicking the native eye structure as described in paragraph [0043] of Bango.
Regarding claim 32, Christie-2/Bango makes obvious the intraocular implant as claimed in claim 31, Bango further teaches wherein the biocompatible material comprises collagen ([0043]).
Regarding claim 33, Christie-2/Bango makes obvious the intraocular implant as claimed in claim 31, Bango further teaches wherein the lamellae are arranged alternately at right angles to respective neighboring lamellae ([0043]; Fig 1).
Regarding claim 34, Christie-2/Bango makes obvious the intraocular implant as claimed in claim 31, Bango further teaches wherein the lamellae are interwoven (fibers are arranged vertically and horizontally, similar to a native collagen lamellar sheet and are therefore interpreted as interwoven, [0043]).
Regarding claim 38, Christie-2 discloses the intraocular implant as claimed in claim 27; yet, is silent wherein the lattice structure further comprises at least one of the following additions:
growth factors; crosslinkers; keratocytes; stem cells; anti-inflammatory agents; nanoparticles; solvents; and membranes.
Bango further teaches properly prepared collagen thin films are those that have been etched to create a regular lattice structure consisting of horizontal and vertical fibril elements that are spaced apart, where the addition of glycerose is used to effect crosslinking to bind the collagen films together as a unit ([0043]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the application to have modified the lattice structure of Christie-2 to include collagen as taught by Bango in order to more closely mimic the structure of the eye and it would have further been obvious to one having ordinary skill in the art to have the lattice structure include crosslinkers in the process of making the eye replacement structure as taught by Bango, since the method of creating a lattice structure with a crosslinker is known to be beneficial for binding collagen films together as a unit as described in paragraph [0043] of Bango.
Regarding claim 39, Christie-2/Bango makes obvious the intraocular implant as claimed in claim 38; yet does not explicitly disclose nanoparticles are present and arranged at locally different concentrations in the lattice structure, such that there is a different refractive index in lamellar layers, radial zones of the implant or both. Bango further teaches a corneal replacement structure that has nanoparticles such as mucopolysaccharides present in the interfibrillar or interstitial spaces ([0035]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have nanoparticles present in the lattice structure as taught by Bango in order to promote health, mechanical integrity and optical clarity of the replacement structure ([0035]).
Where the modified implant of Christie-2/Bango would have the nanoparticles at locally different concentrations such that there is a different refractive index in lamellar layers, radial zones of the implant or both (nanoparticles are located in the interfibrillar space and are varied in different layers of the implant since the nanoparticles must flow freely with water and oxygen, [0035]; and Christie-2 teaches an irregular lattice structure, see claim 1 and [0264], that would have the nanoparticles localize in different concentrations).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Christie-2 in view of Christie-3 (US2012/0143325).
Regarding claim 43, Christie-2 discloses the intraocular implant as claimed in claim 27; yet, is silent regarding the intraocular implant comprises a corneal implant that contains pigments, arranged such that an artificial iris is created. Christie-3 teaches a corneal implant (see Abstract) that may contain pigments to mimic the properties of an iris ([0084], [0094], [0129]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the application to have modified the implant of Christie-2 to include a corneal implant that contains pigments, as taught by Christie-3, in order to render the implant substantially or completely opaque to optimally replace and mimic damaged iris tissue that controls and regulates the opening of the size of the pupil ([0084], [0094]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/M.A.M/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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