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 action is entered in response to Applicant's Amendment and Reply of 6/25/26. 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 Claims 45-56 are withdrawn.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 6/25/26, 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 and the amendments have overcome the previous rejection. However, a new grounds of rejection have been made in view of Nigam (US6102946).
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 37 and 43 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 37 recites the limitation “the material and/or lattice structure is configured such that part of the visible light is absorbed". Claim 27 from which claim 37 depends recited “lattice structure is optically transparent”. It is unclear how the limitation from claim 37 can be an option for the lattice structure when it is previously recited as a transparent.
Claim 43 recites the limitation “wherein the intraocular implant comprises a corneal implant that contains pigments, arranged such that an artificial iris is created”. Claim 27 from which claim 43 depends recited “lattice structure is optically transparent”. It is unclear how the implant can have pigment that creates an iris when the lattice structure is previously recited ed as a transparent.
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 27, 28, 30, 35-37, and 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over Nigam (US6102946).
Regarding claim 27, Nigam discloses an intraocular corneal implant for implantation in a cornea (C5:L23-34), the intraocular corneal implant comprising:
a dimensionally stable lattice structure (the implant being dimensionally stable lattice structure by being a matrix of cross-linked polymer, C8:L7-15; the implant interpreted as having an dimensionally stable lattice in line with the specification page 5, lines 9-11 “more or less a regular inner structure… but is flexible during insertion”) that is dimensionally stable in a deployed state when implanted within the cornea (the implant is already a formed matrix before insertion into the cornea) and that is structured, sized and shaped to be implanted into the cornea (C6:L1-12), 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 9-11 “more or less a regular inner structure… but is flexible during insertion” by having a matrix of cross-linked polymer, C3:L16-20, and has an elastic internal structure by the need to mimic natural lens structure which is elastic, C1:L25-28), 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 (C7:L16-30);
the dimensionally stable lattice structure having a microscopically irregular framework structure thereby to mitigate diffraction effects when implanted into the cornea (the implant has irregular passageways which would mitigate diffractions effects in the same manner by being openings through the implant, C7:L16-30); and
wherein the dimensionally stable lattice structure defines channels with a diameter of > 1 um (micropores or passageways in the implant represent channels and can have a diameter of > 1 micron, C7:L33-36) and webs (wall structures defined between the micropores or passages would define a web structure as best interpreted by the specification);
wherein the dimensionally stable lattice structure is optically transparent (C2:L6-9);
wherein a z-axis measurement of the dimensionally stable lattice structure varies along at least one of the x-axis or y-axis (the implant is curved up in the z-direction, see annotated Fig. 4a).
Nigam does not explicitly disclose the webs with a dimension of < 50 um. Nigam teaches the micropores or passageways can be 1 micron or greater in diameter (C7:L33-37) and are irregularly spaced in order to permit adequate nutrient and fluid transfer to prevent tissue necrosis, but small enough to act as a barrier against tissue ingrowth (C3:L3-7). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the webs with a dimension of < 50 um to have the structure with channels and webs imitate natural human tissue for adequate nutrient and fluid transfer to prevent necrosis (C3:L3-7 of Nigam).
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Regarding claim 28, Nigam makes obvious the intraocular implant as claimed in claim 27, the lattice structure further supports the mobility of endogenous cells to colonize the implant (C7:L25-28).
Regarding claim 30, Nigam makes obvious the intraocular implant as claimed in claim 27, wherein the channels have a diameter of > 3 micrometers (holes are dimension with a diameter of about 1 micron or more, C7:L33-37); yet, does not explicitly disclose the webs have a dimension of < 20 micrometers. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the webs with a dimension of < 50 um in order to have the structure with channels and webs imitate natural human tissue for adequate nutrient and fluid transfer to prevent necrosis (C3:L3-7 of Nigam).
Regarding claim 35, Nigam makes obvious the intraocular implant as claimed in claim 27, wherein the intraocular implant is adapted for a preferential direction for cell movement (C7:L25-28).
Regarding claim 36, Nigam makes obvious the intraocular implant as claimed in claim 27; in which mechanical properties, optical properties or both of the implant vary spatially (the implant can be oval or elliptical in shape with a longer axis in the direction of cylindrical power addition dependent on the treatment of the eye, C2:L46-55).
Regarding claim 37, Nigam makes obvious 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 (C2:L36-38).
Regarding claim 40, Nigam discloses an intraocular corneal implant for implantation in a cornea (C5:L23-25), the intraocular corneal implant comprising:
a dimensionally stable lattice structure (the implant being dimensionally stable lattice structure by being a matrix of cross-linked polymer, C8:L7-15; the implant interpreted as having an dimensionally stable lattice in line with the specification page 5, lines 9-11 “more or less a regular inner structure… but is flexible during insertion”) sized and shaped to be implanted into the cornea that is dimensionally stable in a deployed state when implanted within the cornea (the implant is already a formed matrix before insertion into the cornea), having a stable but elastic internal lattice structure (interpreted as having an elastic internal structure in line with the specification page 5, lines 9-11 “more or less a regular inner structure… but is flexible during insertion” by having a matrix of cross-linked polymer, C3:L16-20, and has an elastic internal structure by the need to mimic natural lens structure which is elastic, C1:L25-28), 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 (C7:L16-30);
the dimensionally stable lattice structure having a microscopically irregular framework structure to thereby mitigate diffraction effects when implanted in the cornea (the implant has irregular passageways which would mitigate diffractions effects in the same manner by being openings through the implant, C7:L16-30) and wherein the dimensionally stable lattice structure defines channels with a diameter of> 1 um (micropores or passageways in the implant represent channels and can have a diameter of > 1 micron, C7:L33-36) and webs (wall structures defined between the micropores or passages would define a web structure as best interpreted by the specification);
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 would allow for liquid to fill the structure, C7:L42-44), 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),
wherein a z-axis measurement of the dimensionally stable lattice structure varies along at least one of the x-axis or y-axis (the implant is curved up in the z-direction, see annotated Fig. 4a).
Nigam does not explicitly disclose webs with a dimension of < 50 um. Nigam teaches the micropores or passageways can be 1 micron or greater in diameter (C7:L33-37) and are irregularly spaced in order to permit adequate nutrient and fluid transfer to prevent tissue necrosis, but small enough to act as a barrier against tissue ingrowth (C3:L3-7). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the webs with a dimension of < 50 um to have the structure with channels and webs imitate natural human tissue for adequate nutrient and fluid transfer to prevent necrosis (C3:L3-7 of Nigam).
Regarding claim 41, Nigam 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, Nigam discloses an intraocular implant for implantation in a cornea (C5:L23-25), the intraocular implant comprising:
a dimensionally stable lattice structure (the implant being dimensionally stable lattice structure by being a matrix of cross-linked polymer, C8:L7-15; the implant interpreted as having an dimensionally stable lattice in line with the specification page 5, lines 9-11 “more or less a regular inner structure… but is flexible during insertion”) structured, sized and shaped to be implanted into the cornea that is dimensionally stable in a deployed state when implanted within the cornea (the implant is already a formed matrix before insertion into cornea), having a stable but elastic internal lattice structure (interpreted as having an elastic internal structure in line with the specification page 5, lines 9-11 “more or less a regular inner structure… but is flexible during insertion” by having a matrix of cross-linked polymer, C3:L16-20, and has an elastic internal structure by the need to mimic natural lens structure which is elastic, C1:L25-28), 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 (C7:L16-30);
the dimensionally stable lattice structure having a microscopically irregular framework structure to thereby mitigate diffraction effects when implanted into the cornea (the implant has irregular passageways which would mitigate diffractions effects in the same manner by being openings through the implant, C7:L16-30); and
wherein the dimensionally stable lattice structure defines channels with a diameter of > 1 um (micropores or passageways in the implant represent channels and can have a diameter of > 1 micron, C7:L33-36) and webs (wall structures defined between the micropores or passages would define a web structure as best interpreted by the specification);
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]),
wherein the dimensionally stable lattice structure is optically transparent (C2:L6-9);
wherein a z-axis measurement of the dimensionally stable lattice structure varies along at least one of the x-axis or y-axis (the implant is curved up in the z-direction, see annotated Fig. 4a).
Nigam does not explicitly disclose webs with a dimension of < 50 um. Nigam teaches the micropores or passageways can be 1 micron or greater in diameter (C7:L33-37) and are irregularly spaced in order to permit adequate nutrient and fluid transfer to prevent tissue necrosis, but small enough to act as a barrier against tissue ingrowth (C3:L3-7). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the webs with a dimension of < 50 um to have the structure with channels and webs imitate natural human tissue for adequate nutrient and fluid transfer to prevent necrosis (C3:L3-7 of Nigam).
Claims 31-34, 38, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Nigam (US6102946) in view of Bango (US2003/0232287).
Regarding claim 31, Nigam makes obvious 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, Nigam/Bango makes obvious the intraocular implant as claimed in claim 31, Bango further teaches wherein the biocompatible material comprises collagen ([0043]).
Regarding claim 33, Nigam/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, Nigam/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, Nigam makes obvious 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 Nigam 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, Nigam/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 to promote health, mechanical integrity and optical clarity of the replacement structure ([0035]).
Where the modified implant of Nigam/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] of Bango; and Nigam teaches an irregular lattice structure, C3:L2-8, C8:L13-15, that would have the nanoparticles localize in different concentrations).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Nigam in view of Christie (US2012/0143325).
Regarding claim 43, Nigam makes obvious 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 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 Nigam to include a corneal implant that contains pigments, as taught by Christie, in order to optimally replace and mimic damaged iris tissue that controls and regulates the opening of the size of the pupil ([0084], [0094]).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Nigam (US6102946) in view of Peyman (US2019/0247181).
Regarding claim 44, Nigam discloses the intraocular implant as claimed claim 27; yet, is silent regarding wherein the intraocular implant comprises an intraocular lens (IOL). Peyman teaches an embodiment of treating an eye condition where a corneal implant is inserted into the cornea after an intraocular lens implantation additional refractive error correction ([0144]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the implant further comprise an IOL as taught by Peyman to provide additional refractive error correction ([0144]).
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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
We had
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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