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 .
DETAILED ACTION
Status of Claims
This office action is responsive to the amendment filed on 07/23/2026. As directed by the amendment: claims 1-16 are presently pending in this application.
Response to Arguments
Applicant's arguments with respect to claims 1, 5-7, 8-9 and 11-14 rejected under 35 U.S.C. 103 as being unpatentable over Lui et al. (2009/0222086) “Lui” in view of Lindstrom (4715858) further in view of Graham et al. (5632773) “Graham”; claims 2 and 10 rejected under 35 U.S.C. 103 as being unpatentable over Lui et al. (2009/0222086) “Lui” in view of Lindstrom (4715858) further in view of Graham et al. (5632773) “Graham” further in view of Peyman (2019/0269826); claim 3 rejected under 35 U.S.C. 103 as being unpatentable over Lui et al. (2009/0222086) “Lui” in view of Lindstrom (4715858) further in view of Graham et al. (5632773) “Graham” further in view of Clauson et al. (2011/0238075) “Clauson” and claim 15 rejected under 35 U.S.C. 103 as being unpatentable over Lui et al. (2009/0222086) “Lui” in view of Lindstrom (4715858) further in view of Graham et al. (5632773) “Graham” further in view of Peyman (5722971) “Peyman ‘971”; claim 16 rejected under 35 U.S.C. 103 as being unpatentable over Lui et al. (2009/0222086) “Lui” in view of Lindstrom (4715858) further in view of Graham et al. (5632773) “Graham” further in view of Villain et al. (5634943) “Villain”
have been considered but are moot in view of the new ground(s) of rejection.
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.
Claims 1, 5-7 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lui et al. (2009/0222086) “Lui” in view of Lindstrom (4715858) further in view of Graham et al. (5632773) “Graham” further in view of Peyman (2019/0269826).
Regarding claim 1, Lui discloses a method of producing a corneal implant 18 (Fig. 4 and claim 6), comprising: forming a body formed from a material that is configured to resorb into tissue of a cornea over a period of time (abstract and par. 0015 disclose a resorbable implant; claim 6), the body having an anterior surface and a posterior surface (the top and bottom surfaces of the implant; Figs. 1 and 4); and applying a first drug coating 12 applied to an anterior surface of the body (Fig. 1 and par. 0015 disclose a coating); the first drug coating or the second drug coating formulated at least to promote keratocyte proliferation in and around the body (par. 0025 discloses using growth factors to allow cellular growth and par. 0040 discloses the growth of fibroblasts into the stromal side of the implant); wherein the body serves as a tissue scaffold to promote growth of corneal tissue (claims 1 and 3 disclose the body is resorbable and allows for growth of corneal endothelial cells); except for disclosing and/or applying a second drug coating to a posterior surface of the body, the first drug coating or the second drug coating formulated at least to promote keratocyte proliferation in and around the body, wherein the body is formed with a porous microstructure that promotes keratocyte mobility from the native stromal tissue surrounding the body, and wherein the body serves as a tissue scaffold to promote growth of corneal tissue.
However, Lindstrom teaches a similar method of producing a corneal implant 40 (Fig. 4) comprising a second drug coating 42 applied to a posterior surface of the body (Fig. 4 and col. 2, lin. 51-55 disclose the corneal implant is coated on anterior and posterior sides). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method in Lui to include applying a second drug coating to a posterior surface of the body, as taught and suggested by Lindstrom, for allowing cellular growth on both sides of the lens resulting in a better attachment of the implant with the surrounding tissue (col. 2, lin. 51-55 of Lindstrom).
Furthermore, Graham teaches a similar method of producing a corneal implant comprising a coating formulated at least to promote keratocyte proliferation in and around the body (col. 1, lin. 36-42 disclose the growth of stromal keratocytes). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method in Lui in view of Lindstrom to include a coating formulated at least to promote keratocyte proliferation in and around the body, as taught and suggested by Graham, for allowing keratocyte growth into the stromal portion of the lens resulting in a better attachment of the implant with the surrounding tissue.
Furthermore, Peyman teaches a similar corneal implant 128 (Fig. 12) comprising a body formed with a porous microstructure (par. 0196 discloses the corneal implant has a body made of porous flexible polymer) that promotes keratocyte mobility from the native stromal tissue surrounding the body (the structure of the implant 128 is fully capable of performing this intended use). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the corneal implant in Liu, Lindstrom and Graham to include body is formed with a porous microstructure that promotes keratocyte mobility from the native stromal tissue surrounding the body, as taught and suggested by Peyman, for the purpose of using organic resorbable materials that can deliver medication at certain concentrations (par. 0286 of Peyman).
Regarding claims 5-7, the combination of Lui in view of Lindstrom discloses shaping the anterior surface of the body to impart a refractive change in the cornea; wherein the anterior surface of the body is convex to increase curvature of an anterior surface of the cornea and wherein the anterior surface of the body is concave to decrease curvature of an anterior surface of the cornea (par. 0027 of Lui discloses the polymer can be molded to have any desired shape and col. 1, lin. 58-63 of Lindstrom discloses a lens having a radius of curvature for shaping the cornea for correcting refractive condition).
Regarding claims 8, 9 and 11, Lui discloses the material is configured to resorb into the corneal tissue over a period of time and over a plurality of weeks by hydrolytic or enzymatic action and the body is formed from a bioresorbable polymer (abstract discloses a resorbable polymer which is fully capable of performing the intended use of being configured to resorb into the corneal tissue over a plurality of weeks by hydrolytic or enzymatic action).
Regarding claim 12, Lui discloses the first drug coating or the second drug coating elute over the period of time for resorption of the body (par. 0015 discloses the coating is biodegradable).
Regarding claim 13, Lui discloses the first drug coating or the second drug coating include a growth factor (par. 0025 discloses using growth factors to allow cellular growth).
Regarding claim 14, Lui discloses wherein the body 18 has a neutral shape that does not impart changes to a curvature of an anterior surface of the cornea (as shown in Fig. 4).
Regarding claim 10, Lui in view of Lindstrom and Graham discloses the claimed invention; except for the bioresorbable polymer includes polylactide (PLA), polycaprolactone (PCL), or poly(lactide-co-glycolide) (PLGA). However, Peyman teaches a similar corneal implant 128 (Fig. 12) comprising the bioresorbable polymer includes polylactide (PLA), polycaprolactone (PCL), or poly(lactide-co-glycolide) (PLGA) (par. 0286 discloses the implant is made of polycaprolactone). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the corneal implant in Liu, Lindstrom and Graham to include body is formed with a porous microstructure that promotes keratocyte mobility from the native stromal tissue surrounding the body and the bioresorbable polymer includes polylactide (PLA), polycaprolactone (PCL), or poly(lactide-co-glycolide) (PLGA), as taught and suggested by Peyman, for the purpose of using organic resorbable materials that can deliver medication at certain concentrations (par. 0286 of Peyman).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lui et al. (2009/0222086) “Lui” in view of Lindstrom (4715858) further in view of Graham et al. (5632773) “Graham” further in view of Peyman (2019/0269826) further in view of Clauson et al. (2011/0238075) “Clauson”.
Lui in view of Lindstrom, Graham and Peyman discloses the claimed invention of claim 1; except for the first drug coating or the second drug coating includes a plurality of drugs that are layered to allow the plurality of drugs to elute according to an order. However, Clauson teaches a similar method of producing a corneal implant 105 (Fig. 4D) comprising the first drug coating or the second drug coating includes a plurality of drugs that are layered to allow the plurality of drugs to elute according to an order r (par. 0053 discloses the implant 105 has a plurality of drug layers on the surface and on the interior of the implant). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method in Liu, Lindstrom, Graham and Peyman to include the first drug coating or the second drug coating includes a plurality of drugs that are layered to allow the plurality of drugs to elute according to an order, as taught and suggested by Clauson, for the purpose of providing the implant the ability to have varying drug release profiled (par. 0072).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lui et al. (2009/0222086) “Lui” in view of Lindstrom (4715858) further in view of Graham et al. (5632773) “Graham” further in view of Peyman (2019/0269826) further in view of Peyman (5722971) “Peyman ‘971”.
Lui in view of Lindstrom, Graham and Peyman discloses the claimed invention; except for the corneal implant has a thickness of approximately 100 um to approximately 300 um. However, Peyman ‘971 teaches a similar corneal implant 630 comprising a thickness of approximately 100 um to approximately 300 um (col. 19, lin. 26-27). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the corneal implant in Liu, Lindstrom, Graham and Peyman to include has a thickness of approximately 100 um to approximately 300 um, as taught and suggested by Peyman ‘971, for the purpose of using a thickness that closely fits the corneal anatomy.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lui et al. (2009/0222086) “Lui” in view of Lindstrom (4715858) further in view of Graham et al. (5632773) “Graham” further in view of Peyman (2019/0269826) further in view of Villain et al. (5634943) “Villain”.
Lui in view of Lindstrom, Graham and Peyman discloses the claimed invention; except for the body has optical transmissivity in a wavelength range from approximately 400 nm to approximately 700 nm. However, Villain teaches a similar corneal implant comprising body has optical transmissivity in a wavelength range from approximately 400 nm to approximately 700 nm (col. 5, lin. 7-16). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the corneal implant in Liu, Lindstrom, Graham and Peyman to include the body has optical transmissivity in a wavelength range from approximately 400 nm to approximately 700 nm, as taught and suggested by Villain, for the purpose of allowing the implant to transmit more light than the normal cornea (col. 5, lin. 14-16 of Villain).
Allowable Subject Matter
Claim 4 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The closest prior art of record of Lui et al. (2009/0222086) “Lui”, Lindstrom (4715858) and Graham et al. (5632773) “Graham” fail to disclose “wherein the first drug coating or the second drug coating include a growth factor and a cross-linking agent layered to allow the growth factor to elute prior to the cross-linking agent, the cross-linking agent generating chemical cross-links between native collagen fibers and collagen formed in and around the body”.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri. If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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