DETAILED ACTION
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 election with traverse of Group I and the species DMTMM, claims 1-4, 6-11, 15, 17, 18, 20, and 21, in the reply filed on 2 July 2025 is acknowledged. The traversal is on the ground(s) that the limitation of “a ring-shaped area on a surface of said stem cell carrier substrate” that “is provided with a pattern of niches positioned so as to coincide, after transplantation with a limbus,” is a special technical feature. This is not found persuasive because Marmo et al. teach that the device, including the stem cell carrier substrate, is ring-shaped (see Fig. 3a). The device may also include cellular attachment elements, such as indentations over all or a fraction of the lens, where the indentations may be provided in a plurality of concentric rings emanating from the center of the lens and expanding radially outward (Para. 86). The indentations that are a plurality of concentric rings are an area on the surface of the stem cell carrier substrate that is a pattern of niches, which are in a position to coincide with a limbus after transplantation.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5, 13, 14, 16, and 19 have been withdrawn. Claims 1-4, 6-11, 15, 17, 18, 20, and 21 are currently pending and under examination.
This Application is a national phase application under 35 U.S.C. §371 of International Application No. PCT/EP2020/087811, filed 23 December 2020, which claims priority to European Application No. EP19219707.7, filed 24 December 2019.
Claim Objections
Claim 8 is objected to because of the following informalities: the abbreviation “RHC” should first be presented with the full term written out, such as “recombinant human collagen (RHC) Type I.” Appropriate correction is required.
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 1-3, 8-11, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Marmo et al. (IDS; US 2005/0080484, Published 2005).
With regard to claim 1, Marmo et al. teach an ophthalmological device (Abs.), the ophthalmological device comprising a lens, which is a cell carrier substrate (Abs.). The cells on the carrier substrate can include stem cells, a mixture of stem cells and differentiated epithelial cells, or differentiated epithelial cells (Para. 17). The stem cells are limbal stem cells from, which epithelial cells are derived (Abs.), thus the stem cells are limbal epithelial stem cells. As Marmo et al. expressly teach that the cells on the carrier substrate may be, or include, stem cells, and where the stem cells include limbal epithelial stem cells, it would have been obvious to one of ordinary skill in the art to provide a culture of limbal epithelial stem cells on the cell carrier substrate.
The stem cell carrier substrate comprises a hydrogel containing collagen or collagen-mimicking peptides (Para. 16, 87). The device, including the stem cell carrier substrate, is ring-shaped (see Fig. 3a). The device may also include cellular attachment elements, such as indentations over all or a fraction of the lens, where the indentations may be provided in a plurality of concentric rings emanating from the center of the lens and expanding radially outward (Para. 86). The indentations that are a plurality of concentric rings are an area on the surface of the stem cell carrier substrate that is a pattern of niches, which are in a position to coincide with a limbus after transplantation.
Marmo et al. render obvious the device as claimed, utilizing the components as claimed. As the device cannot be separated from its properties, the device as rendered obvious would necessarily be capable of being used for treatment of Limbal Stem Cell Deficiency.
With regard to claim 2, Marmo et al. teach that the device, including the stem cell carrier substrate, has the shape of a dome (see Fig. A-B; Para. 65). The indentations may be provided over the entire lens (stem cell carrier substrate) or over a fraction of the lens (Para. 86). Additionally, no indentations are present on the optic zone (48) of the stem cell carrier substrate (see Fig. 4A-B). As such, it would have been obvious to an ordinary artisan to keep the optic zone, which is the central portion of the dome, free of indentations, which are niches.
With regard to claim 3, Marmo et al. teach that the device, including the stem cell carrier substrate, is ring-shaped (see Fig. 3a).
With regard to claim 8, Marmo et al. teach that the stem cell carrier substrate hydrogel may comprise Type I collagen, include recombinant collagen (Para. 16, 70).
With regard to claims 9, 10, and 21, Marmo et al. teach that the device may include cellular attachment elements, where the indentations may be provided in a plurality of concentric rings emanating from the center of the lens and expanding radially outward (Para. 86), wherein the concentric rings are deemed to be regularly spaced groves. It is further taught that the lens of the device has a diameter between about 6 mm and about 12 mm, the thickness of the lens near the center is about 30 and 200 µm thick, and the thickness of the peripheral edge of the lens is less than about 30 µm (Para. 66-68). While the distance between the concentric rings is not specifically taught, it would have been routine for an ordinary artisan to determine the most appropriate width between grooves that fit on the diameter and thickness of the lens as taught, depending on the type and concentration of all the cells and components desired to be loaded onto the lens for implantation.
Additionally, please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)). Accordingly, it would have been obvious to optimize the width of grooves, including from 15-150 µm, or 50-90 µm, to result in grooves of an appropriate width depending on the type and concentration of all the cells and components desired to be loaded onto the lens for implantation.
With regard to claim 11, Marmo et al. teach that the carrier substrate can include a mixture of stem cells and differentiated epithelial cells (Para. 17), wherein the differentiated epithelial cells are a pharmaceutical component that is loaded onto the stem cell carrier substrate.
Claims 1, 4, 6, 7, 15, 17, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Marmo et al., as applied to claim 1 above, and further in view of Griffith et al. (WO 2018/069873; Published 2018).
The teachings of Marmo et al. as applied to claim 1 have been set forth above.
With regard to claims 4, 6, 7, 15, 17, 18, and 20, while Marmo et al. teach that the stem cell carrier substrate comprises collagen (Para. 70), it is not taught that stem cell carrier substate comprises a 12% or 18% Collagen-Like Peptide (CLP) hydrogel, or that the CLP hydrogel is crosslinked with DMTMM.
Griffith et al. teach collagen and collagen-like peptide-based hydrogels for use as corneal implants, where the collagen and collagen-like peptides are crosslinked with DMTMM, and their use in the preparation of a hydrogel and corneal implant is highly efficacious and robust compared to existing corneal implants (Abs.). The CLP is present in amounts between 10% to 18% (claim 16), wherein it would have been obvious to one of ordinary skill in the art to utilize an amount within the expressly taught range, which includes 12% and 18% CLP.
It would have been obvious to one of ordinary skill in the art to combine the teachings of Marmo et al. with Griffith et al., because both teach a collagen-containing ophthalmological device for implantation. CLP-based hydrogels for use as corneal implants, where the CLP is present in amounts including 12% and 18%, and is crosslinked with DMTMM, is known in the art as taught by Griffith et al. The use of DMTMM crosslinked 12% and 18% CLP hydrogels as taught by Griffith et al., as the stem cell carrier substrate in the ophthalmological device of Marmo et al., amounts to the simple substitution of one know collagen-based hydrogel material for another, and would have been expected to predictably and successfully provide an alternative material for the hydrogel of Marmo et al.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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