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 .
Status of Claims
Claims 2-21 are rejected. Claim 1 is canceled.
Response to Arguments
Claim Objections
The previous claim objections of claims 3 and 16 have been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 112
The previous 112(b) rejections have been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 103
Regarding claim 2, Applicant's arguments filed 7/24/26 have been fully considered but they are not persuasive.
Applicant asserts that the Office Action does not present evidence that Muller discloses or suggests a corneal holder that is elongated as is claimed and as is depicted in, for example, FIG. 6c of the pending application. However, the Examiner disagrees. Muller teaches an elongated cornea holder (¶62-a body 76 with a surface 78, the surface 78 can form a mandrel for stably holding the donor cornea 50 (or donor eye); Fig. 16B-a longitudinal axis through the middle).
Applicant asserts that the Office Action does not present evidence that either Muller or Shibata discloses an upper curve surface along a portion of the surface area as recited in claim 2. However, the Examiner disagrees. Muller teaches an upper curved surface along a portion of a surface area of the elongated cornea holder base (¶62-the surface 78 may be contoured to cover or otherwise accommodate the general shape of donor corneas 50; Fig. 16B).
Applicant asserts that the Office Action does not even address the claim limitation of claim 2 that the claimed structure is an alignment cover. However, the Examiner disagrees. While Muller does not teach wherein the cornea holder further comprises a cornea holder alignment cover, configured to be placed on top of the elongated cornea holder base, Shibata teaches wherein the cornea holder further comprises a cornea holder alignment cover, configured to be placed on top of the elongated cornea holder base (¶169- the cover glass 51 is an optical member covering the cornea, the holder 52 holds the cover glass 51).
Regarding claim 15, Applicant's arguments filed 7/24/26 have been fully considered but they are not persuasive.
Applicant asserts that the Office Action does not present evidence that Muller discloses or suggests a corneal holder that is elongated as is claimed. However, the Examiner disagrees. Muller teaches an elongated cornea holder (¶62-a body 76 with a surface 78 that engages the donor cornea 50).
Applicant asserts that the Office Action does not present evidence that either Muller or Shibata discloses an upper curve surface along a portion of the surface area as is recited in claim 2. However, the Examiner disagrees. Muller teaches an upper curved surface along a portion of a surface area (¶62-the surface 78 may be contoured to cover or otherwise accommodate the general shape of donor corneas 50; Fig. 16B).
Applicant asserts that the Office Action does not present evidence that Shibata discloses a cornea holder alignment cover, configured to be placed on top of the elongate corneal holder base as recited in independent claim 15. However, the Examiner disagrees. Shibata teaches wherein the elongated cornea holder further comprises a cornea holder alignment cover configured to be placed on top of the elongated cornea holder base (¶169-the cover glass 51 is an optical member covering the cornea, the holder 52 holds the cover glass 51).
Applicant asserts that the Office Action does not present evidence that the cited references disclose or suggest that the dissected cornea potion is not separated from the cornea as is recited in independent claim 15. However, the Examiner disagrees. Muller teaches while said dissected cornea portion is placed on said cornea holder and is not separated from the cornea on said cornea holder (¶27-produce and employ eye implants to reshape the cornea in order to correct vision; ¶51-the reshaping of the front surface 14 and the back surface 12 can be formed on the laminar sheet 52 at step 515 ′ such that when the implant 10 is formed when the lenticule 54 is cut from the laminar sheet at step 520 ′; ¶65-the laminar sheet(s) 52 are cut from the section of the donor cornea 50 disposed along the surface 78).
Regarding claim 19, Applicant's arguments filed 7/24/26 have been fully considered but they are not persuasive.
Applicant asserts that Muller does not disclose or suggest an elongated cornea holder base having a longitudinal axis. However, the Examiner disagrees. Muller teaches an elongated cornea holder base having a longitudinal axis (¶62-a body 76 with a surface 78, the surface 78 can form a mandrel for stably holding the donor cornea 50 (or donor eye); Fig. 16B-a longitudinal axis through the middle).
Applicant asserts that the combination of Muller and Skelnik does not teach an upper curved surface along at least 50% but less than 100% of a surface area of the elongated cornea holder base. However, the Examiner disagrees. Muller teaches an upper curved surface of a surface (¶62-the surface 78 may be contoured to cover or otherwise accommodate the general shape of donor corneas 50; Fig. 16B). While Muller does not explicitly teach along at least 50% but less than 100% of a surface area, Skelnik teaches along at least 50% but less than 100% of a surface area (¶20-the corneal basket includes upper and lower disc support surfaces to allow a greater range of cornea sizes to reside in the container. The corneal basket is structured to allow the area between the upper disc support surfaces and the container base to have an open area greater than 38%, and more preferably at least 50%, to allow improved movement of solutes residing within the preservation medium; the area of the upper curved surface would be less than 100% since there is also a lower disc support surface).
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, 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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 4, 9, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Muller (US 20140264980 filed on 1/10/14 as cited in the IDS) in view of Shibata (US 20150335479 filed on 3/2/15).
Regarding claim 2, Muller teaches a cornea holder, comprising: an elongated cornea holder base having a longitudinal axis (¶62-a body 76 with a surface 78, the surface 78 can form a mandrel for stably holding the donor cornea 50 (or donor eye); Fig. 16B-a longitudinal axis through the middle) and an upper curved surface along a portion of a surface area of the elongated cornea holder base (¶62-the surface 78 may be contoured to cover or otherwise accommodate the general shape of donor corneas 50; Fig. 16B), the cornea holder being elongated parallel to the longitudinal axis (¶62-a body 76 with a surface 78, the surface 78 can form a mandrel for stably holding the donor cornea 50 (or donor eye); Fig. 16B-a longitudinal axis runs through the middle and body 76 with a surface 78 runs parallel to the longitudinal axis); wherein said upper curved surface is shaped and sized to hold at least a portion of a cornea in a curved orientation (¶62-a surface 78 that engages the donor cornea 50, the surface 78 may be contoured to cover or otherwise accommodate the general shape of donor corneas 50; Fig. 16B). However, Muller does not teach wherein the cornea holder further comprises a cornea holder alignment cover, configured to be placed on top of the elongated cornea holder base.
Shibata relates to an ophthalmic laser surgery apparatus for treating a patient's eye by irradiating the patient's eye with a laser beam, and an eyeball fixing portion movement unit and an eyeball fixing unit which are used in the ophthalmic laser surgery apparatus (¶2). Shibata further teaches the invention using the following step:
wherein the cornea holder further comprises a cornea holder alignment cover, configured to be placed on top of the elongated cornea holder base (¶169- the cover glass 51 is an optical member covering the cornea, the holder 52 holds the cover glass 51).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include wherein the cornea holder further comprises a cornea holder alignment cover, configured to be placed on top of the elongated cornea holder base of Shibata in order to decrease rising of ocular tension caused by a movement of the eyeball fixing unit pressing the patient's eye (Shibata, ¶268).
Regarding claim 4, the combination of Muller and Shibata teaches the cornea holder according to claim 2, comprising an alignment portion located at or adjacent to said upper curved surface or on the cornea holder alignment cover (Shibata, ¶234-perform positional alignment of the eyeball fixing unit 280 and the interface unit 50 in the XY-direction, and positional alignment of a coarse adjustment in the Z-direction; ¶240-perform the alignment operation in the XY-direction by checking the luminescent spot, the pupil, the cornea, and the like projected in the frontal image of the anterior chamber displayed in the display portion 93; Fig. 4-adjacent curved surface 281; ¶205); wherein said alignment portion comprises one or more alignment markings shaped and sized to align said upper curved surface with alignment markings or a coordinate system of a laser surgical device (Shibata, ¶306-when detecting the alignment state of the apparatus 1 and the patient's eye E, the detection unit may set the luminescent spot of the cornea as the detection target. The luminescent spot of the cornea is easily detected and detection accuracy of the alignment state can be enhanced. Moreover, as the detection target, a laser irradiation target (for example, the crystalline lens, the cornea, and the like) may be adopted as the detection target; ¶2-an eyeball fixing portion movement unit and an eyeball fixing unit which are used in the ophthalmic laser surgery apparatus).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include an alignment portion located at or adjacent to said upper curved surface or on the cornea holder alignment cover; wherein said alignment portion comprises one or more alignment markings shaped and sized to align said upper curved surface with alignment markings or a coordinate system of a laser surgical device of Shibata in order for positioning to be performed more accurately (Shibata, ¶122) and to correct the laser irradiation region (Shibata, ¶416).
Regarding claim 9, the combination of Muller and Shibata teaches the cornea holder according to claim 2, wherein the cornea holder alignment cover is hollow (Shibata, ¶169-the holder 52 holds the cover glass 51; Fig. 4-the base 52 goes inside part of cover 51) and configured to facilitate placing the cornea holder alignment cover around the cornea holder base (Shibata, ¶169-the holder 52 holds the cover glass 51; Fig. 4-the cover 51 goes around part of base 52).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include wherein the cornea holder alignment cover is hollow and configured to facilitate placing the cornea holder alignment cover around the cornea holder base of Shibata in order to cover at least a portion of the cornea without being in contact with the cornea (Shibata, ¶169).
Regarding claim 14, the combination of Muller and Shibata teaches the cornea holder according to claim 2, wherein the cornea holder alignment cover and the corner holder base are fixed relative to each other when the corneal holder base is positioned within the cornea holder alignment cover to mitigate relative movement between the cornea holder alignment cover and the cornea holder base during laser activation (Shibata, ¶169-the interface unit 50 (refer to FIG. 4) approaches the cornea of the patient's eye E, weakens refractive power of the cornea, and performs a role of causing a laser beam to easily reaches (be concentrated) the ocular tissue such as the crystalline lens, the interface unit 50 mainly includes the cover glass 51 and a holder 52; Fig. 4-shows how holder 52 goes into cover 51; ¶268-allows the interface unit 50 (the cover glass 51 ) to be positioned with respect to the patient's eye E (Step 12 ). Therefore, it is possible to decrease rising of ocular tension caused by a movement of the eyeball fixing unit 280 , pressing the patient's eye).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include wherein the cornea holder alignment cover and the corner holder base are fixed relative to each other when the corneal holder base is positioned within the cornea holder alignment cover to mitigate relative movement between the cornea holder alignment cover and the cornea holder base during laser activation of Shibata in order to treat a patient's eye by irradiating the patient's eye with a laser beam (Shibata, ¶2) and decrease rising of ocular tension caused by a movement of the eyeball fixing unit pressing the patient's eye (Shibata, ¶268).
Regarding claim 15, Muller teaches a method for reshaping a cornea, comprising: placing the cornea, selected from the group consisting of an in-vitro formed cornea implant, a human donor cornea lenticule or a human donor cornea on an elongated cornea holder (¶62-a body 76 with a surface 78 that engages the donor cornea 50); the cornea holder comprising an elongated cornea holder base having a longitudinal axis (¶62-a body 76 with a surface 78, the surface 78 can form a mandrel for stably holding the donor cornea 50 (or donor eye); Fig. 16B-a longitudinal axis through the middle) and an upper curved surface along a portion of a surface area of the elongated cornea holder base (¶62-the surface 78 may be contoured to cover or otherwise accommodate the general shape of donor corneas 50; Fig. 16B); wherein said upper curved surface is shaped and sized to hold at least a portion of the cornea in a curved orientation (¶62-a surface 78 that engages the donor cornea 50, the surface 78 may be contoured to cover or otherwise accommodate the general shape of donor corneas 50; Fig. 16B); the method further comprising dissecting said cornea to define boundaries of a dissected cornea portion while said cornea is placed on said elongated cornea holder (¶65-cut the laminar sheet(s) 52 from the donor cornea 50 without passing through the body 76 or any other part of the first engagement device 62 (e.g., at one or more angles generally parallel to the contour of the surface 78), the laminar sheet(s) 52 are cut from the section of the donor cornea 50 disposed along the surface 78; ¶62-the surface 78 can form a mandrel for stably holding the donor cornea 50 (or donor eye)); and geometrically reshaping an outline of an external surface of said dissected cornea portion while said dissected cornea portion is placed on said cornea holder and is not separated from the cornea on said cornea holder (¶27-produce and employ eye implants to reshape the cornea in order to correct vision; ¶51-the reshaping of the front surface 14 and the back surface 12 can be formed on the laminar sheet 52 at step 515 ′ such that when the implant 10 is formed when the lenticule 54 is cut from the laminar sheet at step 520 ′; ¶65-the laminar sheet(s) 52 are cut from the section of the donor cornea 50 disposed along the surface 78). However, Muller does not teach wherein the elongated cornea holder further comprises a cornea holder alignment cover configured to be placed on top of the elongated cornea holder base.
Shibata teaches wherein the elongated cornea holder further comprises a cornea holder alignment cover configured to be placed on top of the elongated cornea holder base (¶169-the cover glass 51 is an optical member covering the cornea, the holder 52 holds the cover glass 51).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include wherein the elongated cornea holder further comprises a cornea holder alignment cover configured to be placed on top of the elongated cornea holder base of Shibata in order to decrease rising of ocular tension caused by a movement of the eyeball fixing unit pressing the patient's eye (Shibata, ¶268).
Regarding claim 16, the combination of Muller and Shibata teaches the method according to claim 15, wherein said dissecting further comprises dissecting said cornea to define a cornea portion after said dissecting having a maximal dimension of at least 7 mm (Muller, ¶69-the second cutting mechanism 68 cuts and/or reshapes one or more lenticules 54 to form individual implant(s) 10 to desired outer diameters (e.g., approximately 7 mm)).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Shibata as applied to claim 2 above, and further in view of Dyakov (EP 1790316 filed on 6/10/05).
Regarding claim 3, the combination of Muller and Shibata teaches the cornea holder according to claim 2. However, the combination of Muller and Shibata does not teach wherein said upper curved surface has a radius of curvature in a range of 7 millimeters (mm)-9 millimeters (mm) along an entirety of said upper curved surface.
Dyakov teaches wherein said upper curved surface has a radius of curvature in a range of7 millimeters (mm)-9 millimeters (mm) along an entirety of said upper curved surface (¶36-a support plate 1, the support plate 1 being designed as a convex concave lens with a radius of curvature of 7-10 mm).
Dyakov belongs to the medical field, namely ophthalmic (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include wherein said upper curved surface has a radius of curvature in a range of 7 millimeters (mm)-9 millimeters (mm) along an entirety of said upper curved surface of Dyakov in order for the radius of curvature of the support plate to correspond to the corneal radius of curvature of the patient (Dyakov, ¶36).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Shibata as applied to claim 4 above, and further in view of Dykes (US 20050203554 filed on 3/10/04).
Regarding claim 5, the combination of Muller and Shibata teaches the cornea holder according to claim 4. However, the combination of Muller and Shibata does not teach wherein the alignment markings are shaped as elongated indentations or channels.
Dykes teaches wherein the alignment markings are shaped as elongated indentations or channels (¶16-the corneal marking device according to the present invention is provided with one or more protrusions configured to make a temporary indent, preferably a temporary dimple, and provide temporary markings or a pattern of markings on the surface of the cornea by application of pressure).
Dykes relates to a medical device for marking the cornea of an eyeball, and method of cornea marking (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include wherein the alignment markings are shaped as elongated indentations or channels of Dykes in order to help the eye surgeon to correct astigmatic vision, and locate and judge specific positions between the adjacent sets of protrusions for proper placement of the conductive keratoplasty tip during conductive keratoplasty (Dykes, ¶37).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Shibata as applied to claim 4 above, and further in view of Cunanan (US 20070280994 filed on 6/1/06).
Regarding claim 6, the combination of Muller and Shibata teaches the cornea holder according to claim 4. However, the combination of Muller and Shibata does not teach wherein the cornea holder alignment cover comprises at least two alignment channels and a central opening on an upper surface thereof; the at least two alignment channels crossing through the central opening and positioned at a known angle relative to each other.
Cunanan teaches wherein the cornea holder alignment cover comprises at least two alignment channels and a central opening on an upper surface thereof (¶34-tissue separation area 100 is formed by separation of a cover portion or flap 104 of corneal tissue from the surface of cornea 16. Tissue separation area 100 is shown here partially open with flap 104 lifted from the surface of cornea 16; ¶40-barrier region 108 preferably has a plurality of channel-like/ridge-like configurations with intersection angles 120-126 equal to 90 degrees or substantially 90 degrees; Fig. 2E shows it is above cornea 16; Fig. 2A); the at least two alignment channels crossing through the central opening and positioned at a known angle relative to each other (¶40-a plurality of channel-like/ridge-like configurations with intersection angles 120-126 equal to 90 degrees or substantially 90 degrees; ¶34-a portion of corneal tissue 105 is left connected between flap 104 and cornea 16 to form a hinge about which flap 104 can be opened and closed).
Cunanan relates generally to ocular tissue separation areas with barrier regions and, more particularly, to methods and systems for forming intrastromal tissue separation areas with one or more barrier structures located around a lens implantation site (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include wherein the cornea holder alignment cover comprises at least two alignment channels and a central opening on an upper surface thereof; the at least two alignment channels crossing through the central opening and positioned at a known angle relative to each other of Cunanan in order to provide further protection against epithelial migration, such as another layer of protection in case the structural integrity of one channel is compromised (Cunanan, ¶44).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Shibata as applied to claim 4 above, and further in view of Lieberman (US 5312428 filed on 10/10/91).
Regarding claim 7, the combination of Muller and Shibata teaches the cornea holder according to claim 4. However, the combination of Muller and Shibata does not teach wherein said alignment portion comprises one or more rotation orientation markings shaped and sized to be positioned near at least a portion of a cornea; wherein said one or more rotation orientation marking are configured to allow marking of the cornea by forming a cut or a void in the cornea to set a rotation orientation of the cornea with respect to said rotation orientation marking of the alignment portion.
Lieberman teaches wherein said alignment portion comprises one or more rotation orientation markings shaped and sized to be positioned near at least a portion of a cornea (col. 2 and lines 9-13-wherein a donor's corneal tissue is marked with respect to the donor's left or right eyes and the rotational orientation so that the donor's corneal tissue can be reattached to the patient's correct left or right eye and maintain the same rotational orientation); wherein said one or more rotation orientation marking are configured to allow marking of the cornea by forming a cut or a void in the cornea to set a rotation orientation of the cornea with respect to said rotation orientation marking of the alignment portion (col. 1 and lines 59-64-cutting block are maintained or keyed in a fixed rotational orientation so that the rotational orientation of the cut corneal tissue can be determined and maintained, so that cut corneal tissue or button can be transplanted onto the patient's eye in the same rotational orientation as it existed in the donor's eye; col. 2 and lines 30-31-cutting either round or other than round corneal buttons from the donor's corneal tissue; col. 3, line 67—col. 4, line 3-passageway 36 also positively positions the piston 38 and the cutting blade 40 so that the cutting blade will move along a defined path to assure an accurate and central cut of the donor tissue positioned on the cutting block 20).
Lieberman relates to ophthalmic surgery and more particularly to a corneal punch and method of cutting the cornea of the eye for performing a corneal transplant (col. 1 and lines 5-8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include wherein said alignment portion comprises one or more rotation orientation markings shaped and sized to be positioned near at least a portion of a cornea; wherein said one or more rotation orientation marking are configured to allow marking of the cornea by forming a cut or a void in the cornea to set a rotation orientation of the cornea with respect to said rotation orientation marking of the alignment portion of Lieberman so that the donor's corneal tissue can be reattached to the patient's correct left or right eye and maintain the same rotational orientation as it existed in the original donor's eye to limit the degree of surgically induced astigmatism created in the patient's eye (Lieberman, col. 2 and lines 11-16).
Regarding claim 8, the combination of Muller, Shibata, and Lieberman teaches the cornea holder according to claim 7, wherein said one or more rotation orientation markings comprises an opening or an indentation in said alignment portion (Lieberman, col. 3 and lines 41-53-block 20 further has two holes 30 and 32 having diameters of 1/8 and 3/16 inches, respectively, for receiving upstanding pins 26 and 28 of the depression 18 to properly rotationally orientate the corneal cutting block 20 to the base 10. Block 20 further includes an ear 34 to mark the "twelve o'clock" position of cutting block 20 with respect to the donor corneal tissue (not shown) and punching device. Thus, when block 20 is properly positioned in the depression 18 of base 10 as shown in FIG. 2, an aspheric curve is formed therein to receive the donor corneal tissue (not shown) in the proper rotational orientation with respect to the cutting block and corneal punch system; col. 2 and lines 30-31-cutting either round or other than round corneal buttons from the donor's corneal tissue).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include wherein said one or more rotation orientation markings comprises an opening or an indentation in said alignment portion of Lieberman so that the donor's corneal tissue can be reattached to the patient's correct left or right eye and maintain the same rotational orientation as it existed in the original donor's eye to limit the degree of surgically induced astigmatism created in the patient's eye (Lieberman, col. 2 and lines 11-16).
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Shibata as applied to claim 2 above, and further in view of Reich (US 20170023800 filed on 10/10/16).
Regarding claim 10, the combination of Muller and Shibata teaches the cornea holder according to claim 2, wherein the cornea holder alignment cover comprises an alignment cover base having a longitudinal axis (Shibata, ¶169- the cover glass 51 is an optical member covering the cornea, the holder 52 holds the cover glass 51; Fig. 4-a longitudinal axis going through the middle of 51).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include wherein the cornea holder alignment cover comprises an alignment cover base having a longitudinal axis of Shibata in order to cover at least a portion of the cornea without being in contact with the cornea (Shibata, ¶169).
However, the combination of Muller and Shibata does not teach a central opening at the upper surface of the cornea holder alignment cover.
Reich teaches a central opening at the upper surface of the cornea holder alignment cover (¶423-the support 210 comprises an opening 212, the support 210 may comprise a lower portion 220 to couple to the covering; Fig. 2B shows the opening above the upper surface of cover 100).
Reich relates to visual rehabilitation and treatment of pain for patients with epithelial defects on the cornea of the eye (¶3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include a central opening at the upper surface of the cornea holder alignment cover of Reich in order for alignment and placement on the cornea (Reich, ¶423).
Regarding claim 11, the combination of Muller, Shibata, and Reich teaches the cornea holder according to claim 10, wherein the central opening defines a round opening or an oval opening (Reich, ¶423-the support 210 comprises an opening 212, Fig. 2A shows the central opening 212 is a round opening).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include wherein the central opening defines a round opening or an oval opening of Reich in order for alignment and placement on the cornea (Reich, ¶423).
Regarding claim 12, the combination of Muller, Shibata, and Reich teaches the cornea holder according to claim 10, wherein the central opening is shaped and sized to allow at least a partial penetration of a cornea positioned on the curved surface of the cornea holder base from within a lumen of the cornea holder alignment cover (Reich, ¶423-the support 210 comprises an opening 212, the support 210 may comprise a lower portion 220 to couple to the covering, coupling 220 of the support to the covering can be used to carry the covering for alignment and placement on the cornea; Fig. 2B); and wherein the central opening is shaped and sized to allow at least a partial penetration of the curved surface through the opening from within the lumen of the cornea holder alignment cover or both of the foregoing (Reich, ¶423-the support 210 comprises an opening 212, the support 210 may comprise a lower portion 220 to couple to the covering, coupling 220 of the support to the covering can be used to carry the covering for alignment and placement on the cornea; Fig. 2B-shows curved surface 100 partially going through opening 212).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include wherein the central opening is shaped and sized to allow at least a partial penetration of a cornea positioned on the curved surface of the cornea holder base from within a lumen of the cornea holder alignment cover; and wherein the central opening is shaped and sized to allow at least a partial penetration of the curved surface through the opening from within the lumen of the cornea holder alignment cover or both of the foregoing of Reich in order for alignment and placement on the cornea (Reich, ¶423) and visual rehabilitation and treatment of pain for patients with epithelial defects on the cornea of the eye (Reich, ¶3).
Regarding claim 13, the combination of Muller and Shibata teaches the cornea holder according to claim 2, when the cornea holder base is positioned at least partially within a lumen of the holder alignment cover (Shibata, ¶169-the holder 52 holds the cover glass 51; Fig. 4-the base 52 goes inside part of cover 51).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include when the cornea holder base is positioned at least partially within a lumen of the holder alignment cover of Shibata in order to cover at least a portion of the cornea without being in contact with the cornea (Shibata, ¶169).
However, the combination of Muller and Shibata does not teach wherein the upper curved surface defines a central opening and wherein the central opening and the upper curved surface are co-axial.
Reich teaches wherein the upper curved surface defines a central opening and wherein the central opening and the upper curved surface are co-axial (¶423-the support 210 comprises an opening 212, the support 210 may comprise a lower portion 220 to couple to the covering; Fig. 2B shows the curved surface and the central opening being co-axial).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include wherein the upper curved surface defines a central opening and wherein the central opening and the upper curved surface are co-axial of Reich in order for alignment and placement on the cornea (Reich, ¶423).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Shibata as applied to claims 2 and 15 above, and further in view of Skelnik (US 20110008877 filed on 6/17/10).
Regarding claim 17, the combination of Muller and Shibata teaches the cornea holder according to claim 2. However, the combination of Muller and Shibata does not teach wherein the upper curved surface occupies at least 50% but less than 100% of the surface area of the elongated corneal holder base.
Skelnik teaches wherein the upper curved surface occupies at least 50% but less than 100% of the surface area of the elongated corneal holder base (¶20-the corneal basket includes upper and lower disc support surfaces to allow a greater range of cornea sizes to reside in the container. The corneal basket is structured to allow the area between the upper disc support surfaces and the container base to have an open area greater than 38%, and more preferably at least 50%, to allow improved movement of solutes residing within the preservation medium; the area of the upper curved surface would be less than 100% since there is also a lower disc support surface).
Skelnik relates to devices and methods that improve cornea preservation (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include wherein the upper curved surface occupies at least 50% but less than 100% of the surface area of the elongated corneal holder base of Skelnik in order to allow a greater range of cornea sizes to reside in the container (Skelnik, ¶20) and improved movement of solutes residing within the preservation medium (Skelnik, ¶20).
Regarding claim 18, the combination of Muller and Shibata teaches the method according to claim 15. However, the combination of Muller and Shibata does not teach wherein the upper curved surface occupies at least 50% but less than 100% of the surface area of the elongated corneal holder base.
Skelnik teaches wherein the upper curved surface occupies at least 50% but less than 100% of the surface area of the elongated corneal holder base (¶20-the corneal basket includes upper and lower disc support surfaces to allow a greater range of cornea sizes to reside in the container. The corneal basket is structured to allow the area between the upper disc support surfaces and the container base to have an open area greater than 38%, and more preferably at least 50%, to allow improved movement of solutes residing within the preservation medium; the area of the upper curved surface would be less than 100% since there is also a lower disc support surface).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include wherein the upper curved surface occupies at least 50% but less than 100% of the surface area of the elongated corneal holder base of Skelnik in order to allow a greater range of cornea sizes to reside in the container (Skelnik, ¶20) and improved movement of solutes residing within the preservation medium (Skelnik, ¶20).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Skelnik.
Regarding claim 19, Muller teaches a cornea holder, comprising: an elongated cornea holder base having a longitudinal axis (¶62-a body 76 with a surface 78, the surface 78 can form a mandrel for stably holding the donor cornea 50 (or donor eye); Fig. 16B-a longitudinal axis through the middle) and an upper curved surface of a surface area of the elongated cornea holder base (¶62-the surface 78 may be contoured to cover or otherwise accommodate the general shape of donor corneas 50; Fig. 16B); wherein said upper curved surface is shaped and sized to hold at least a portion of a cornea in a curved orientation (¶62-a surface 78 that engages the donor cornea 50, the surface 78 may be contoured to cover or otherwise accommodate the general shape of donor corneas 50; Fig. 16B). However, Muller does not explicitly teach along at least 50% but less than 100% of a surface area.
Skelnik teaches along at least 50% but less than 100% of a surface area (¶20-the corneal basket includes upper and lower disc support surfaces to allow a greater range of cornea sizes to reside in the container. The corneal basket is structured to allow the area between the upper disc support surfaces and the container base to have an open area greater than 38%, and more preferably at least 50%, to allow improved movement of solutes residing within the preservation medium; the area of the upper curved surface would be less than 100% since there is also a lower disc support surface).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include at least 50% but less than 100% of a surface area of Skelnik in order to allow a greater range of cornea sizes to reside in the container (Skelnik, ¶20) and improved movement of solutes residing within the preservation medium (Skelnik, ¶20).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Skelnik as applied to claim 19 above, and further in view of Shibata.
Regarding claim 20, the combination of Muller and Skelnik teaches the cornea holder according to claim 19. However, the combination of Muller and Skelnik does not teach further comprising a cornea holder alignment cover, configured to be placed on top of the elongated cornea holder base.
Shibata teaches further comprising a cornea holder alignment cover, configured to be placed on top of the elongated cornea holder base (¶169- the cover glass 51 is an optical member covering the cornea, the holder 52 holds the cover glass 51).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include further comprising a cornea holder alignment cover, configured to be placed on top of the elongated cornea holder base of Shibata in order to decrease rising of ocular tension caused by a movement of the eyeball fixing unit pressing the patient's eye (Shibata, ¶268).
Regarding claim 21, the combination of Muller, Skelnik, and Shibata teaches the cornea holder according to claim 20, further comprising an alignment portion located at or adjacent to said upper curved surface or on the cornea holder alignment cover (Shibata, ¶234-perform positional alignment of the eyeball fixing unit 280 and the interface unit 50 in the XY-direction, and positional alignment of a coarse adjustment in the Z-direction; ¶240-perform the alignment operation in the XY-direction by checking the luminescent spot, the pupil, the cornea, and the like projected in the frontal image of the anterior chamber displayed in the display portion 93; Fig. 4-adjacent curved surface 281; ¶205); wherein said alignment portion comprises one or more alignment markings shaped and sized to align said upper curved surface with alignment markings or a coordinate system of a laser surgical device (Shibata, ¶306-when detecting the alignment state of the apparatus 1 and the patient's eye E, the detection unit may set the luminescent spot of the cornea as the detection target. The luminescent spot of the cornea is easily detected and detection accuracy of the alignment state can be enhanced. Moreover, as the detection target, a laser irradiation target (for example, the crystalline lens, the cornea, and the like) may be adopted as the detection target; ¶2-an eyeball fixing portion movement unit and an eyeball fixing unit which are used in the ophthalmic laser surgery apparatus).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Muller to include an alignment portion located at or adjacent to said upper curved surface or on the cornea holder alignment cover; wherein said alignment portion comprises one or more alignment markings shaped and sized to align said upper curved surface with alignment markings or a coordinate system of a laser surgical device of Shibata in order for positioning to be performed more accurately (Shibata, ¶122) and to correct the laser irradiation region (Shibata, ¶416).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20040243160, which relates to surgical systems for cutting the cornea of a patient's eye (¶2).
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.
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/L.N.H./Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
