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 .
Applicant’s preliminary amendment filed February 4, 2026 is acknowledged. Claims 27-43 are pending in the application. Claims 27-43 will be examined.
Priority
This application is a National Stage Entry for PCT/EP2023/060961 filed April 26, 2023, which claims benefit to U.S. Provisional Application No. 63/348,099 filed June 2, 2022.
Information Disclosure Statement
Receipt of Information Disclosure Statement filed March 6, 2025 is acknowledged.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 27, 28, 29, 30, 31, 32, 33, 36, 37, 38, 39, 40, 41, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Jun et al. (US 2013/0053952). Jun et al. cited by Applicant on the IDS filed 3/6/2026.
Applicant’s Invention
Applicant claims a method of treatment of an eye disorder in an eye of a subject, wherein the treatment comprises a method comprising the steps of -applying a crosslinkable liquid composition onto an anterior corneal surface of said eye comprising said eye disorder; -crosslinking the crosslinkable liquid composition on the anterior corneal surface of the eye, thereby obtaining a crosslinked composition on the anterior corneal surface of the eye; and, -correcting the curvature of the crosslinked composition, wherein the eye disorder is a refractive error or a chronic or subacute corneal disease involving an irregularity of the cornea, and wherein the method comprises introducing said crosslinkable liquid composition into a mold which is positioned onto the anterior corneal surface of the eye.
Determination of the scope of the content of the prior art
(MPEP 2141.01)
Regarding claim 27, Jun et al. teach a corneal reshaping kit comprising: a mold defining a concavity that is sized and shaped for receiving an outer corneal surface, such that a corneal surface pressed against the concavity will adopt a convex shape complementary to the concavity; and a biocompatible, flowable material suitable for introduction into a space within a cornea (page 3, claim 1).
Regarding claim 28, Jun et al. teach it is currently in widespread use in laser refractive surgery to precisely construct a separation in the anterior portion of the cornea prior to the reshaping of the cornea with the excimer laser to achieve vision correction. In one embodiment, the shaping agent is an implanted device 4, such as shown in FIG. 2. It may be an optically clear, thin, rigid, material with curved front and back surfaces which will fit within the corneal stromal space (page 1, paragraph 15).
Jun et al. teach the polymer is curable (page 3, claim 4).
Jun et al. teach the kit of claim 4 wherein the polymer is curable by application of light (page 3, claim 5).
Regarding claim 29, Jun et al. teach removing the mold from the outer corneal surface after the material has sufficiently hardened so that the outer corneal surface maintains the convex shape in the absence of the mold (page 3, claim 13). Jun et al. teach the mold may be removed at any time once the injected material is capable of retaining the desired shape (page 2, paragraph 19).
Regarding claims 27 and 30, Jun et al. teach cutting the cornea to create a space defined by the cornea; injecting the material of the kit of claim 1 into the space; pressing the concavity of the mold of the kit of claim 1 to an outer surface of the cornea so that the outer corneal surface adopts a convex shape complementary to the concavity of the mold (page 3, claim 13);
Regarding claims 31 and 32, Jun et al. teach a flowable shaping agent, such as a polymer, may be cured in any number of ways, including application of light, application of heat, application of particle radiation, or use of a chemical additive. A photoinitiator may be included in the flowable agent (page 2, paragraph 22).
Regarding claims 33 and 36, Jun et al. teach a particular preferred polymer for this application is polyethylene glycol, although other polymers or non-polymer biocompatible materials may be used. Examples of synthetic, biocompatible polymers are polyethylene glycol (PEG), polyvinyl alcohol (PVA) (page 2, paragraph 18).
Regarding claims 37 and 38, Jun et al. teach the curing may involve any process by which the injected material goes from flowable state to a state in which it is capable of maintaining a desired shape. This could involve crosslinking (page 2, paragraph 23).
Regarding claim 39, Jun et al. teach the device may be round with an anterior base curve between 8-9 mm and a posterior base curve between 6-9 mm. The thickness of the device may be between 50-150 micrometers (page 1, paragraph 16).
Regarding claims 42 and 43, Jun et al. teach the external mold is typically applied during the time after the flowable material has been injected into the cornea and before the material becomes rigid. The mold may be applied with compression to help impress on the cornea a shape complementary to the mold. The surface of the mold 9 in contact with the corneal surface may have a shape approximating normal corneal curvature (e.g., for cases in which the cornea is abnormally shaped such as keratoconus or post-refractive surgery corneal ectasia) or a shape designed to compensate for refractive errors elsewhere in the cornea or eye (e.g. myopia, hyperopia, presbyopia, and/or astigmatism) (page 2, paragraph 19).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Jun et al. do not teach the crosslinked composition is resistant to biodegradation for a period of at least 6 months or the biodegradation for a period of at least 12 months.
Finding a prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to use the teachings of Jun et al. and know that the crosslinked composition is resistant to biodegradation for a period of at least 6 months or the biodegradation for a period of at least 12 months. Jun et al. teach a corneal reshaping kit comprising: a mold defining a concavity that is sized and shaped for receiving an outer corneal surface, such that a corneal surface pressed against the concavity will adopt a convex shape complementary to the concavity; and a biocompatible, flowable material suitable for introduction into a space within a cornea. Jun et al. teach the biocompatible, flowable material is a polymer and that polymer is polyethylene glycol or polyvinyl alcohol. As such, following the prior art teaching that if the same crosslinked composition, polyethylene glycol, is taught in the prior art, one that is biocompatible, flowable material, the skilled artisan would expect to obtain a result that necessarily flows with the intended purpose and properties, i.e., resistance to biodegradation for a period of at least 6 months or at least 12 months, without evidence to the contrary.
Therefore, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Jun et al. (US 2013/0053952) as applied to claims 27, 28, 29, 30, 31, 32, 33, 36, 37, 38, 39, 40, 41, and 42 above, and further in view of Dana et al. (US 2022/0001074). Jun et al. and Dana et al. cited by Applicant on the IDS filed 3/6/2026.
Applicant’s Invention
Applicant claims a method of treatment of an eye disorder in an eye of a subject, wherein the treatment comprises a method comprising the steps of -applying a crosslinkable liquid composition onto an anterior corneal surface of said eye comprising said eye disorder; -crosslinking the crosslinkable liquid composition on the anterior corneal surface of the eye, thereby obtaining a crosslinked composition on the anterior corneal surface of the eye; and, -correcting the curvature of the crosslinked composition, wherein the eye disorder is a refractive error or a chronic or subacute corneal disease involving an irregularity of the cornea, and wherein the method comprises introducing said crosslinkable liquid composition into a mold which is positioned onto the anterior corneal surface of the eye.
Determination of the scope of the content of the prior art
(MPEP 2141.01)
The teachings of Jun et al. with respect to the 35 U.S.C. 103 rejection is hereby incorporated and are therefore applied in the instant rejection as discussed above.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Jun et al. do not specifically disclose the crosslinkable biomaterial is a protein-based polymer, gelatin methacryloyl (GelMa). It is for this reason Dana et al. is added as a secondary reference.
Dana et al. teach treatment of corneal lacerations, we developed a novel bioadhesive hybrid hydrogel by using a naturally derived polymer, gelatin, and a synthetic biopolymer, polyethylene glycol (PEG). We further chemically modified gelatin and PEG to form photocrosslinkable gelatin methacryloyl (GelMA) and Poly(ethylene glycol) diacrylate (PEGDA). By combination of GelMA and PEGDA at different ratios, in the presence of photoinitiator solution, and can be photocrosslinked upon short-time exposure to visible light (450-550 nm), forming a solid hydrogel that firmly adheres to the corneal tissue. Furthermore, in vivo tests were conducted using a rabbit stromal cornea defect model to test the biocompatibility and retention of the biomaterial, as well as sealing corneal laceration after the application (page 12, paragraph 164).
Dana et al. teach the development of a novel bioadhesive hybrid hydrogel by using a naturally derived polymer, gelatin, and a synthetic polymer, polyethylene glycol (PEG). Gelatin and PEG are further chemically modified to form photocrosslinkable GelMA and PEGDA. Different ratios of GelMA and PEGDA can be photocrosslinked in the presence of a photoinitiator upon short-time exposure to visible light (400-600 nm), forming solid hydrogels that firmly adhere to the corneal tissue (page 7, paragraph 59).
Finding a prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to combine the teachings of Jun et al. and Dana et al. and use a protein-based polymer, gelatin methacryloyl (GelMa) in the compositions and methods taught by Jun et al. Jun et al. teach a corneal reshaping kit comprising: a mold defining a concavity that is sized and shaped for receiving an outer corneal surface, such that a corneal surface pressed against the concavity will adopt a convex shape complementary to the concavity; and a biocompatible, flowable material suitable for introduction into a space within a cornea. Jun et al. teach the biocompatible, flowable material is a polymer. Jun et al. teach the biocompatible, flowable polymer is used to treat corneal disorder. One of ordinary skill in the art would have been motivated to use the teaching Dana et al. that teaches the use of GelMA and PEGDA at different ratios, in the presence of photoinitiator solution, that is photocrosslinked upon short-time exposure to visible light (450-550 nm), forming a solid hydrogel that firmly adheres to the corneal tissue to repair injuries to soft tissue as the polymer in Jun et al. As such, the skilled artisan would have been motivated to substitute GelMa with a reasonable expectation of success, as a person with ordinary skill has good reason to pursue known options within his or technical grasp. Note: MPEP 2141 [R-6] KSR International CO. v. Teleflex lnc. 82 USPQ 2d 1385 (Supreme Court 2007).
Therefore, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andriae M Holt whose telephone number is (571)272-9328. The examiner can normally be reached Monday-Friday, 8:00 am-4:30 pm EST.
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/ANDRIAE M HOLT/ Examiner, Art Unit 1614
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614
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