The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to Applicant’s amendments/remarks received December 16, 2025.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claims 1-30, 41, 56-62 are canceled. Claims 31-40, 42-55, 63-64, 65-67, 68, 69-78 are under consideration.
Priority: This application claims benefit of provisional application 62/693192, filed July 2, 2018.
Objections and Rejections
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.
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 31, 33-34, 35-36, 38, 40, 43, 45-47, 52, 65-67, 69, 71, 75-76, 77-78 are rejected under 35 U.S.C. 103 as being unpatentable over Soker et al. (US 20100215717; IDS 08.01.19, previously cited) in view of Elisseeff et al. (US 20180228599; IDS 07.17.24, previously cited). Soker et al. also disclose a collagenous lenticule comprising a lenticular body derived from human cornea tissue for implantation (at least paragraphs 0008-0010), where the corneal tissue is decellularized (at least paragraphs 0008, 0020, 0023-0024). Soker et al. disclose corneal tissue comprises layers of tissue and collagen (at least paragraphs 0021, 0023-0024). Regarding collagen composition, Soker et al. disclose that type I collagen is the major component, comprising between 50 and 90, or between 60 and 80, or approximately 68% of the dry weight of the decellularized stromal tissue (prior to optional cell seeding), in accordance with its natural occurrence in the cornea (at least paragraph 0037). Soker et al. disclose comparison between native corneal stromas and decellularized stromas show similar mechanical behavior (at least paragraphs 0042, 0073-0074). Soker et al. disclose that these results indicate that decellularization of human corneal stromas reliably removes cellular components from these tissues while preserving both the ECM architecture and adequate mechanical properties (at least paragraph 0074). Soker et al. further disclose that the decellularized human corneal scaffolds retain the biomechanical properties of the native corneas for transplantation surgeries (at least paragraph 0075). Soker et al. do not teach that the collagen has been at least partially cross-linked by actinic radiation.
Elisseeff et al. disclose methods for providing scaffolds for corneal transplantation, comprising treating tissues by decellularization, vitrifying (or drying) the decellularized tissue-base material, molding and cross-linking the decellularized tissue-based material (at least paragraph 0065). Elisseeff et al. disclose a molding method to produce a decellularized cornea comprising compressing and drying decellularized corneal tissue on a printed mold, and cross-linking the decellularized corneal tissue while compacted in the printed mold (at least Fig. 27, also paragraph 0087). Elisseeff et al. also disclose that collagen crosslinking increases the tensile strength of the cornea (at least paragraph 0080) and occurs with UV-A light (at least paragraph 0080). Elisseeff et al. disclose the specific concaved shape of cornea generates the refractive power to assure visual acuity; Elisseeff et al. disclose the decellularized cornea is freely modified with a molding method to change the corneal shape to restore the refractive function of the cornea (at least paragraph 0108). Elisseeff et al. disclose the decellularized cornea scaffold for implantation, including intra-stromal implantation (at least paragraph 0109). Therefore, Elisseeff et al. fairly disclose crosslinking a decellularized corneal scaffold in a compacted state, thereby densifying at least a portion of the collagen fibrils, in a method for preparing a decellularized corneal scaffold. Elisseeff et al. disclose shaping the decellularized cornea for contour and thickness (at least paragraph 0087) and the specific concaved shape of cornea generates the refractive power to assure visual acuity (at least paragraph 0108), where the lenticule has a thickness of between 50 and 200 micrometers (paragraph 0008) and a diameter of 8 mm (paragraph 0067).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the references and arrive at the claimed collagenous lenticule comprising a decellularized lenticular body derived from a corneal donor source having an anterior surface and a posterior surface; the lenticular body comprising collagen that has been compacted along a direction generally perpendicular to the collagen lamellar structure to exhibit a collagen concentration of at least 20%, thereby densifying at least a portion of the collagen fibrils, and having a thickness of between 50 and 200 micrometers, wherein the collagen has been at least partially cross-linked by actinic radiation to enhance mechanical strength, and wherein collagen fibrils in each layer substantially retain their parallel arrangement exhibited in the corneal donor source, wherein the collagenous lenticule exhibits sufficient optical clarity for use in intracorneal implantation (instant claims 31, 52, 75-76, 77-78). The motivation to do so is given by the prior art. Soker et al. disclose a collagenous scaffold processed and shaped (e.g. concave form) from corneal tissue (at least paragraph 0020) and implanted into a patient without prior seeding for corneal transplantation (at least paragraph 0021). Soker et al. disclose comparison between native corneal stromas and decellularized stromas show similar mechanical behavior and that the ECM architecture is preserved (at least paragraphs 0042, 0074). Regarding collagen composition, Soker et al. disclose that type I collagen is the major component, comprising between 50 and 90, or between 60 and 80, or approximately 68% of the dry weight of the decellularized stromal tissue (prior to optional cell seeding), in accordance with its natural occurrence in the cornea (at least paragraph 0037). Elisseeff et al. disclose that in methods for preparing a decellularized corneal scaffold for corneal and intrastromal implantation, the decellularized cornea can be compacted and dried in a mold and then crosslinked while in a compacted state (Fig. 27). Elisseeff et al. disclose that collagen crosslinking increases the tensile strength of the cornea (at least paragraph 0080) and occurs with UV-A light (at least paragraph 0080). Elisseeff et al. disclose that the decellularized crosslinked corneal scaffold for implantation has a thickness of between 50 and 200 micrometers (paragraph 0008) and a diameter of 8 mm (paragraph 0067). Therefore, one of ordinary skill would have reasonable motivation to incorporate the compacting and crosslinking of collagen in a decellularized corneal scaffold as suggested in Elisseeff et al. in the decellularized corneal tissue scaffold processed and shaped for implantation of Soker et al. because decellularized corneal stromas show similar mechanical behavior to native corneal stromas and are suitable for corneal and/or intrastromal implantation and crosslinking increases the tensile strength of the cornea. One of ordinary skill would have a reasonable expectation of success because the same collagen content is present in decellularized cornea and native cornea. Soker et al. and Elisseeff et al. reasonably disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule.
Regarding the instant limitation that the lenticular body comprising collagen fibrils have been “compacted along a direction generally perpendicular to the collagen lamellar structure such that the lenticule exhibits a collagen concentration of at least 20%, wherein the collagen concentration is measured as a fractional weight of the lenticule in a desiccated state relative to a weight of the lenticule in a state in full equilibrium with water”, it is disclosed in the instant specification that “compression” encompasses compaction by application of pressure or by other techniques such as vacuum or centrifugal force-driven water extraction (paragraph 0068 of the application publication). As noted above, Elisseeff et al. disclose compressing and drying the decellularized cornea in a mold prior to crosslinking the decellularized cornea that is compressed or compacted in the mold (Fig. 27); therefore, Elisseeff et al. can be deemed to disclose compaction along a direction generally perpendicular to the collagen structure. It is further known that the amount of collagen in cornea equates to approximately 68% dry weight of the cornea (Soker et al. at least paragraph 0037). Therefore, Soker et al. in view of Elisseeff et al. can be deemed to disclose the decellularized corneal lenticule comprises “compacted” collagen and densified collagen fibrils exhibiting a collagen concentration greater than 20-25% (instant claims 31, 75-76) or greater than 30% (instant claims 52, 77-78), where the decellularized corneal lenticule is for intracorneal or intrastromal implantation, and such that the decellularized corneal lenticule exhibits the recited collagen concentrations of at least 20% or greater than 30%, when the collagen concentration is “measured as a fractional weight of the lenticule in a desiccated state relative to a weight of the lenticule in a state in full equilibrium with water”.
Regarding the instant limitation that the “compacted, crosslinked collagen comprises collagen fibrils distributed in a plurality of layers with the collage fibrils in each layer substantially retaining parallel arrangement exhibited in the corneal donor source whereby the lenticular exhibits sufficient optical clarity for use in intracorneal implantation” (instant claims 31, 52) as noted above, Soker et al. disclose it is known that corneal tissue comprises layers of tissue and/or collagen (at least paragraphs 0021, 0023-0024) and that the collagen fibrils are parallel to the planar surfaces, allowing for transparency (at least paragraphs 0024, 0038). Soker et al. further disclose comparison between native corneal stromas and decellularized stromas show similar mechanical behavior (at least paragraph 0042); and that the extracellular matrix (ECM) architecture is preserved (at least paragraph 0074). Elisseeff et al. also disclose the decellularized cornea is freely modified with a molding method to change the corneal shape to restore the refractive function of the cornea (at least paragraph 0108). Therefore, one of ordinary skill would have reasonable expectation that the compacted and cross-linked collagen in the decellularized corneal lenticule of Soker et al. in view of Elisseeff et al. comprises collagen fibrils in each layer that substantially retain parallel arrangement exhibited in the corneal donor source since Soker et al. disclose the ECM architecture is maintained in decellularized cornea stroma (at least paragraphs 0042, 0074) and Elisseeff et al. disclose the decellularized cornea shaped by molding and crosslinking preserved its transparency (at least paragraphs 0019, 0044, 0057).
Regarding instant claims 33, 65, Soker et al. also disclose that harvested corneal tissue is decellularized (at least paragraphs 0008, 0035-0036, 0037-0038, 0042), where 95% of the cellular material was removed (at least paragraph 0059). Regarding instant claims 66-67, it is known that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this instance, one of ordinary skill would have arrived at removing cellular material >95% from the donor cornea by routine optimization because it more cellular material would be removed.
Regarding instant claim 34, Soker et al. also disclose the decellularized corneal tissue is shaped for corneal implantation (at least paragraph 0020) and Elisseeff et al. disclose the specific concaved shape of cornea generates the refractive power to assure visual acuity; Elisseeff et al. disclose the decellularized cornea is freely modified with a molding method to change the corneal shape to restore the refractive function of the cornea (at least paragraph 0108). Elisseeff et al. disclose the decellularized cornea scaffold for implantation, including intra-stromal implantation (at least paragraph 0109).
Regarding instant claim 40, Soker et al. also disclose a collagenous lenticule comprising a decellularized lenticular body derived from human cornea tissue for implantation (at least paragraphs 0008-0010) and Elisseeff et al. disclose the specific concaved shape of cornea generates the refractive power to assure visual acuity; Elisseeff et al. disclose the decellularized cornea is freely modified with a molding method to change the corneal shape to restore the refractive function of the cornea (at least paragraph 0108). Elisseeff et al. disclose the decellularized cornea scaffold for implantation, including intra-stromal implantation (at least paragraph 0109).
Regarding instant claim 43, Elisseeff et al. disclose methods for providing scaffolds for corneal transplantation, comprising treating tissues by decellularization, vitrifying (or drying) the decellularized tissue-base material, molding and cross-linking the decellularized tissue-based material (at least paragraph 0065, also Fig. 27). Therefore, Elisseeff et al. disclose fluid depletion of the decellularized collagenous lenticule.
Regarding instant claims 45-47, it is noted that the instant claims are still drawn to a decellularized collagenous lenticule regardless of its placement in a container having the recited intended properties. Therefore, the decellularized collagenous lenticule of Soker et al. in view of Elisseeff et al. can be deemed to render instant claims 45-47 obvious because Soker et al. and Elisseeff et al. reasonably disclose a decellularized collagenous lenticule that is materially and structurally the same as the claimed collagenous lenticule and can be further placed in a container (Elisseeff et al. example 1).
Regarding instant claims 35-36, Elisseeff et al. disclose shaping the decellularized cornea for contour and thickness (at least paragraph 0087) and the specific concaved shape of cornea generates the refractive power to assure visual acuity (at least paragraph 0108). Soker et al. disclose a collagenous lenticule comprising a lenticular body derived from human cornea tissue for implantation (at least paragraphs 0008-0010). Soker et al. disclose the lenticule has a thickness of between 50 and 200 micrometers (paragraph 0008) and a diameter of 8 mm (paragraph 0067). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the references and arrive at the claimed collagenous lenticule having a disc-like shape, a diameter of about 8 mm, and a thickness of between 50-200 micrometers (instant claims 35-36). The motivation to do so is given by the prior art. Elisseeff et al. disclose shaping the decellularized cornea for contour and thickness (at least paragraph 0087) and the specific concaved shape of cornea generates the refractive power to assure visual acuity (at least paragraph 0108). It is disclosed that collagenous lenticules derived from cornea tissue for implantation can have a thickness of between 50 and 200 micrometers and a diameter of about 8 mm (Soker et al.). Therefore, one of ordinary skill would have reasonable motivation to shape the thickness and/or diameter of the decellularized collagenous lenticule from donor corneal tissue where the lenticule has a thickness of between 50 and 200 micrometers and a diameter of 8 mm. One of ordinary skill would have a reasonable expectation of success because it is disclosed that a collagenous lenticule can be designed to have the dimensions including a thickness of 50 and 200 micrometers and a diameter of 8 mm for corneal implantation, including intrastromal implantation.
Regarding instant claim 38, Elisseeff et al. also disclose that collagen crosslinking increases the tensile strength of the cornea (at least paragraph 0080) and the decellularized corneal tissue is immersed in the cross-linking while compacted in the printed mold (at least Fig. 27, also paragraph 0087). Elisseeff et al. disclose the specific concaved shape of cornea generates the refractive power to assure visual acuity; Elisseeff et al. disclose the decellularized cornea is freely modified with a molding method to change the corneal shape to restore the refractive function of the cornea (at least paragraph 0108). Elisseeff et al. disclose the decellularized cornea scaffold for implantation, including intra-stromal implantation (at least paragraph 0109). Therefore, it would be obvious that the decellularized corneal tissue suggested in Soker et al./Elisseeff et al. and cross-linked has a cross-linking agent on the surfaces, including the posterior surface.
Regarding instant claims 69, 71, Elisseeff et al. also disclose that collagen crosslinking increases the tensile strength of the cornea (at least paragraph 0080) and occurs with UV-A light (at least paragraph 0080) and/or UV radiation (at least paragraph 0084).
Reply: Applicant’s amendments/remarks have been considered but they are not persuasive. The reasons for maintaining the 103 rejection are the same as previously noted and are incorporated herein.
Regarding Applicant’s remarks that the Chae thesis provides further details regarding the method disclosed in the method of Elisseeff et al., the remarks are not persuasive. Chae, like Elisseeff et al., still disclose methods for preparing a decellularized corneal scaffold for corneal and intrastromal implantation, the decellularized cornea being compacted and dried in a mold and then crosslinked while in a compacted state (Elisseeff et al. Fig. 27), where collagen crosslinking increases the tensile strength of the cornea (Elisseeff et al. at least paragraph 0080).
Regarding Applicant’s remarks that there would no reason one of ordinary skill would consider modifying Soker et al. based on the teachings of Elisseeff et al. because the teachings of Soker et al. are directed to completely different medical modality, anatomical location, and therapeutic purpose than the intra-stromal corneal inlay disclosed in Elisseeff et al., the remarks are not persuasive. Elisseeff et al. disclose that the scaffolds shaped for corneal transplantation can be implanted as a corneal substitute and corneal inlay (p. 9). Soker et al. disclose that the decellularized human corneal scaffolds retain the biomechanical properties of the native corneas for transplantation surgeries (at least paragraph 0075), including surgeries or methods where the scaffold is implanted into the inner layer of the cornea of subject in need thereof (at least paragraphs 0021, 0054), and variations thereof known in the art (at least paragraphs 0021, 0054, 0056-0057). Therefore, the scaffolds disclosed in Soker et al. and Elisseeff et al. are for the same purpose of being a corneal implant and designed for implantation in the cornea tissue, within the cornea tissue, and/or substitute for the cornea tissue in subject in need thereof. Therefore, Applicant’s remarks that the teachings of Soker et al. are directed to completely different medical modality, anatomical location, and therapeutic purpose than the intra-stromal corneal inlay disclosed in Elisseeff et al. are not found persuasive.
As previously noted, it is known that disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). MPEP 2123. In this instance, Soker et al. disclose that the "scaffold" is processed and shaped (e.g. concave form) from corneal tissue (at least paragraph 0020) and implanted into a patient without prior seeding for corneal transplantation (at least paragraph 0021). Therefore, Soker et al. fairly disclose a collagenous lenticule comprising a decellularized lenticular body derived from corneal donor tissue.
Further, Soker et al. is cited with at least Elisseeff et al., which disclose that a decellularized corneal tissue scaffold is suitable for implantation, including intra-stromal implantation (at least paragraph 0109). Therefore, it would be obvious that the decellularized corneal tissue scaffold of Soker et al. disclosed for corneal transplantation can include intra-stromal implantation.
Regarding Applicant’s remarks that if one were to accept Soker et al.’s disclosure, a person of ordinary skill would see no clear need to crosslink such a decellularized corneal stroma and that Soker et al. provide no indication that increasing the tensile strength of an endothelial replacement construct would improve its function, the remarks are not persuasive. In this instance, Soker et al. is cited with Elisseeff et al., which disclose that corneal crosslinking improves visual results more rapidly (paragraph 0079) and increases tensile strength of the cornea (paragraph 0080). Therefore, one of ordinary skill would have reasonable motivation to incorporate the teachings of Elisseeff et al. with Soker et al. because Elisseeff et al. disclose the benefits of crosslinking to a corneal scaffold or implant.
Regarding Applicant’s remarks that introducing additional collagen crosslinks into an endothelial implant can risk disrupting the “pump-leak” balance of actively pumping fluid out of the stroma while preserving a selective barrier, the remarks are not persuasive. The prior art Elisseeff et al. disclose that in addition to increasing tensile strength of the cornea, cross-linking has also been proven to be a treatment for people with eye conditions such as keratoconus, etc. (paragraph 0080). Therefore, Elisseeff et al. do not teach away from crosslinking tissue scaffolds for corneal implants or scaffolds, including the corneal scaffolds of Soker et al. for treating a corneal disease.
Applicant asserts that nor does Soker et al. disclose the collagen concentration recited in amended claim 31. Applicant asserts that the dry weight of the collagen measured by Soker et al. is the weight when the collagen is in a desiccated state. Applicant asserts that the collagen concentration in amended claim 31 clarifies that the collagen concentration is measured as a fractional weight of the lenticule in a desiccated state relative to a weight of the lenticule in a state of full equilibrium with water for intrastromal implantation. Applicant asserts that thus, Soker et al. is not concerned with the concentration of the collagen in the lenticule when the lenticule is in full equilibrium with water, and does not provide any reason to consider any particular collagen concentration for a lenticule that would be implanted in the intrastromal layer.
Applicant’s remarks are not persuasive. As previously noted, Soker et al. has disclosed that in the decellularized corneal tissue, collagen type I is the major component and comprises 50-90%, or 60-80%, or ~68% of the dry weight of the decellularized cornea scaffold, in accordance with its natural occurrence in the cornea (paragraph 0037). It is known that generally differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05. In this instance, even if the 50-90% collagen disclosed in Soker et al. is the dry weight of collagen in the decellularized cornea scaffold, there would still be amounts of collagen present in the collagenous lenticules of Soker et al. and Elisseeff et al. when in a hydrated state. Soker et al. disclose a collagenous lenticule comprising a decellularized lenticular body derived from human cornea tissue for implantation (at least paragraphs 0008-0010) and Elisseeff et al. disclose the specific concaved shape of cornea generates the refractive power to assure visual acuity; Elisseeff et al. disclose the decellularized cornea is freely modified with a molding method to change the corneal shape to restore the refractive function of the cornea (at least paragraph 0108). Soker et al. disclose thicknesses of 50-200 micrometers (paragraph 0008). Therefore, one of ordinary skill would have reasonable expectation that the cross-linked collagenous lenticules comprising decellularized corneal tissue of Soker et al. and Elisseeff et al., comprise the amount of collagen in accordance with its natural occurrence in the cornea, and even if hydrated and comprises a lower weight than the disclosed 50-90% collagen as asserted by Applicant, would still reasonably exhibit a collagen concentration that is at least similar to the recited amount (i.e. more than 20-25%) in a state of equilibrium with water, and it would have been obvious to arrive at the recited amount by routine optimization of shaping the collagenous lenticule thickness and drying. One of ordinary skill would have a reasonable expectation of success because the same collagen content is present in decellularized cornea and native cornea. Soker et al. in view of Elisseeff et al. reasonably disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule.
Applicant asserts that the claimed concentration of at least 20% of collagen fibers in the lenticule advantageously ensures that the lenticule exhibits a high level of transparency as well as sufficient mechanical stability for implantation in a recipient’s stromal layer.
Applicant’s remarks are not persuasive. Soker et al. has disclosed that decellularized human corneal tissue comprises collagen between 50 and 90, or between 60 and 80, or approximately 68% of the dry weight of the decellularized stromal tissue, in accordance with its natural occurrence in the cornea (at least paragraph 0037) and is used for the same purpose as the decellularized corneal donor tissue disclosed in Elisseeff et al. for preparing collagenous scaffolds or lenticules for corneal implantation, including intrastromal implantation (Elisseeff et al. at least paragraphs 0090, 0109), where Elisseeff et al. disclose that the decellularized cornea shaped by molding and crosslinking preserved its transparency (at least paragraphs 0019, 0044, 0057) and that collagen crosslinking increases the tensile strength of the cornea (at least paragraph 0080) and where the decellularized, cross-linked material is highly transparent, biocompatible and stable (at least paragraph 0065). Therefore, one of ordinary skill would have reasonable expectation that the cross-linked collagenous lenticules comprising decellularized, cross-linked corneal tissue of Soker et al. and Elisseeff et al., comprise the amount of collagen in accordance with its natural occurrence in the cornea, including the claimed concentration of at least 20% of collagen fibers, and exhibit the properties recognized in the prior art, and by Applicant, of a high level of transparency and sufficient stability.
Therefore, Applicant’s remarks that the claimed concentration of at least 20% of collagen fibers in the lenticule advantageously ensures a high level of transparency and sufficient mechanical stability are not persuasive.
Applicant asserts that claim 31 recites that the collagen “has been compacted along a direction generally perpendicular to the collagen lamellar structure…”. Applicant asserts that the cited references do not teach, or even suggest, compacting a lenticular body along a direction that is generally perpendicular to the collagen lamellar structure.
Applicant’s remarks are not persuasive. As noted above, Elisseeff et al. disclose compressing and drying the decellularized cornea in a mold prior to crosslinking the decellularized cornea that is compressed or compacted in the mold (Fig. 27).
It is disclosed in the instant specification that “compression” encompasses compaction by application of pressure or by other techniques such as vacuum or centrifugal force-driven water extraction (paragraph 0068 of the application publication). It is also acknowledged in the instant specification that fluid content can be reduced (or equivalently, the collagen concentration can be increased) (paragraph 0097 of the application publication).
Therefore, it would be understood by one of ordinary skill and as disclosed in the prior art that collagen concentration increases when the fluid content of the cornea decreases.
As noted above, it is disclosed that the amount of collagen in decellularized cornea equates to its natural occurrence in the cornea, approximately 68% dry weight of the cornea (Soker et al. at least paragraph 0037). Elisseeff et al. has disclosed that the decellularized cornea shaped by molding and crosslinking preserved its transparency (at least paragraphs 0019, 0044, 0057) and is intended for corneal implantation, including intra-stromal implantation (at least paragraphs 0090, 0109).
Therefore, Soker et al. in view of Elisseeff et al. can be deemed to disclose the decellularized corneal lenticule comprises “compacted” collagen, such that the decellularized corneal lenticule exhibits a collagen concentration greater than 25% (instant claim 31) or greater than 30% (instant claim 52) as recited in the instant claims, where the decellularized corneal lenticule comprising the collagen concentration is for intracorneal or intrastromal implantation. In other words, the amount of collagen present in the decellularized corneal lenticule of Soker et al. in view of Elisseeff et al. would reasonably be in accordance with its natural occurrence in the cornea because Soker et al. has disclosed decellularization preserves the ECM architecture and Elisseeff et al. applying pressure to shape the decellularized cornea in a mold to a desired form and thickness. Therefore, even if the collagen present, approximately 68%, in the decellularized cornea is calculated as the dry weight of the decellularized cornea and is lower when in a hydrated state, it is the amount that is present in natural cornea and therefore, would be a collagen concentration of at least 25% in water for intracorneal or intrastromal implantation.
For at least the reasons noted above, Soker et al. in view of Elisseeff et al. can be deemed to disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule, where the decellularized collagenous lenticule comprises a decellularized lenticular body derived from donor corneal tissue that has been partially compacted, densified, and at least partially cross-linked, has a thickness of 50 and 200 micrometers and a diameter of 8 mm for intrastromal implantation, and wherein the collagen content and structure are substantially retained as exhibited in the donor corneal source and exhibits sufficient optical clarity for use in intracorneal or intrastromal implantation.
Regarding Applicant’s remarks on instant claim 52, the remarks are not persuasive for the reasons similarly noted above for instant claim 31.
For at least these reasons, the 103 rejection is maintained.
Claims 31, 36, 48-51 are rejected under 35 U.S.C. 103 as being unpatentable over Soker et al. (US 20100215717; IDS 08.01.19, previously cited) in view of Elisseeff et al. (US 20180228599; IDS 07.17.24), and Patel et al. (1995 Journal of Refractive Surgery 11: 100-105; previously cited). The teachings of Soker et al. and Elisseeff et al. over at least instant claim 31 is noted above. As noted above, Soker et al. and Elisseeff et al. disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule.
Soker et al. also disclose a collagenous lenticule comprising a lenticular body derived from human cornea tissue for implantation (at least paragraphs 0008-0010), where the corneal tissue is decellularized (at least paragraphs 0008, 0020, 0023-0024). Soker et al. disclose corneal tissue comprises layers of tissue and/or collagen (at least paragraphs 0021, 0023-0024) and that the collagen fibrils are parallel to the planar surfaces, allowing for transparency (at least paragraphs 0024, 0038). Regarding collagen composition, Soker et al. disclose that type I collagen is the major component, comprising between 50 and 90, or between 60 and 80, or approximately 68% of the dry weight of the decellularized stromal tissue (prior to optional cell seeding), in accordance with its natural occurrence in the cornea (at least paragraph 0037). Soker et al. disclose comparison between native corneal stromas and decellularized stromas show similar mechanical behavior and that the ECM architecture is preserved (at least paragraphs 0042, 0073-0074). Soker et al. disclose obtaining corneal tissue from a human cadaveric donor (paragraph 0034).
Elisseeff et al. disclose shaping the decellularized cornea for contour and thickness (at least paragraph 0087). Elisseeff et al. disclose the specific concaved shape of cornea generates the refractive power to assure visual acuity; Elisseeff et al. disclose the decellularized cornea is freely modified with a molding method to change the corneal shape to restore the refractive function of the cornea (at least paragraph 0108). Elisseeff et al. disclose the decellularized cornea scaffold for implantation, including intra-stromal implantation (at least paragraph 0109).
Patel et al. disclose the refractive index varies from the anterior and posterior corneal surfaces (p. 100). Patel et al. disclose the mean refractive index of human corneal stroma anterior and posterior surfaces are 1.380 and 1.373, respectively (p. 100, 103).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the references and arrive at the claimed decellularized collagenous lenticule exhibiting a refractive index greater than 1.377, shaped from donor corneal tissue including humans (instant claims 48-51). The motivation to do so is given by the prior art. Soker et al. also disclose a collagenous lenticule comprising a lenticular body derived from human cornea tissue for implantation, where the lenticule has a thickness of between 50 and 200 micrometers and a diameter of 8 mm. Elisseeff et al. disclose the thickness of the decellularized corneas can be formed to the desired thickness depending upon the refractive powers required of the decellularized corneas. It is disclosed the cornea is commonly regarded as having a refractive index of either 1.376 or 1.377 (Patel et al. p. 100). It is disclosed that the mean refractive index of human corneal stroma anterior and posterior surfaces are 1.380 and 1.373 respectively (Patel et al. p. 100, 103). Therefore, one of ordinary skill would have reasonable motivation to shape the thickness of the collagenous lenticule from decellularized donor corneal tissue where the lenticule exhibits a gradient in refractive index and a refractive index greater than 1.377. One of ordinary skill would have a reasonable expectation of success because it is known that human corneal stroma can have a refractive index greater than 1.378.
Regarding instant claim 36, Patel et al. disclose central thickness of a typical human cornea is 520 μm (p. 102).
Reply: Applicant’s amendments/remarks have been considered but they are not persuasive. The reasons for maintaining Soker et al. and Elisseeff et al. are the same as noted above. Soker et al. in view of Elisseeff et al. can be deemed to disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule, where the decellularized collagenous lenticule comprises a decellularized lenticular body derived from donor corneal tissue that has been partially compacted and at least partially cross-linked, wherein the collagen content and structure are substantially retained as exhibited in the donor corneal source and exhibits sufficient optical clarity for use in intracorneal implantation.
Regarding Applicant’s remarks that it is not clear how Patel et al.’s teaching regarding the refractive index of anterior and posterior surfaces of human corneal stroma would motivate one to impart to the lenticule a refractive index that is greater than the refractive index of the native corneal stromal tissue, the remarks are not persuasive.
While Patel et al. has also disclosed that the cornea is commonly regarded as having a refractive index of either 1.376 or 1.377 (p. 100), it is also disclosed in Patel et al. that the mean refractive index of human corneal stroma anterior and posterior surfaces are 1.380 and 1.373 respectively (Patel et al.). Therefore, it would be obvious that human corneal stroma can also have a refractive index greater than 1.378 because it is similar to the refractive indexes of natural corneas. Further, the deficiency of Patel et al. to not teach the combination of compaction and cross-linking are reasonably remedied by at least Elisseeff et al. for the reasons already noted above.
Claims 31, 39 are rejected under 35 U.S.C. 103 as being unpatentable over Soker et al. (US 20100215717; IDS 08.01.19, previously cited) in view of Elisseeff et al. (US 20180228599; IDS 07.17.24), and Morishige et al. (2011 Investigative Ophthalmology & Visual Science 52(2): 911-915; previously cited). The teachings of Soker et al. and Elisseeff et al. over at least instant claim 31 is noted above. As noted above, Soker et al. and Elisseeff et al. disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule. Soker et al. disclose it is known that corneal tissue comprises layers of tissue and collagen (at least paragraphs 0021, 0023-0024) and that the collagen fibrils are parallel to the planar surfaces, allowing for transparency (at least paragraphs 0024, 0038).
Morishige et al. disclose the collagen lamellae in the anterior stroma of human cornea are highly organized, well interwoven, and densely packed, contributing to maintenance of the 3D structure of the anterior stroma (p. 914).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further increase the cross-linking at an anterior surface region of the decellularized collagenous lenticule of Soker et al. and Elisseeff et al. so that the collagen is more densely packed (instant claim 39). The motivation to do so is given by Morishige et al., which disclose the collagen lamellae in the anterior stroma of human cornea are well interwoven and densely packed, contributing to maintenance of the 3D structure of the anterior stroma. One of ordinary skill would have a reasonable expectation of success because Elisseeff et al. disclose that the decellularized cornea shaped by molding and crosslinking preserved its transparency (at least paragraphs 0019, 0044, 0057) and that collagen crosslinking increases the tensile strength of the cornea (at least paragraph 0080) and where the decellularized, cross-linked material is highly transparent, biocompatible and stable (at least paragraph 0065); thereby maintaining a three-dimensional shape.
Reply: Applicant’s amendments/remarks have been considered but they are not persuasive. The reasons for maintaining Soker et al. and Elisseeff et al. are the same as noted above. Soker et al. and Elisseeff et al. can be deemed to disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule, where the decellularized collagenous lenticule comprises a decellularized lenticular body derived from donor corneal tissue that has been partially compacted and at least partially cross-linked, wherein the collagen content and structure are substantially retained as exhibited in the donor corneal source and exhibits sufficient optical clarity for use in intracorneal implantation.
The deficiency of Morishige et al. to not teach the combination of compaction and cross-linking are reasonably remedied by at least Elisseeff et al. for the reasons already noted above.
Claims 31, 42, 52, 53-55 are rejected under 35 U.S.C. 103 as being unpatentable over Soker et al. (US 20100215717; IDS 08.01.19, previously cited) in view of Elisseeff et al. (US 20180228599; IDS 07.17.24), and Knox et al. (US 20120310223; previously cited). The teachings of Soker et al. and Elisseeff et al. over at least instant claims 31 and 52 are noted above. As noted above, Soker et al. and Elisseeff et al. disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule, where the decellularized collagenous lenticule comprises a decellularized lenticular body derived from donor corneal tissue that has been partially compacted and at least partially cross-linked, wherein the collagen content and structure are substantially retained as exhibited in the donor corneal source and exhibits sufficient optical clarity for use in intracorneal implantation.
Knox et al. disclose modifying the refractive index of ocular tissues for correcting and/or optimizing vision (at least paragraph 0003). For ophthalmic applications, it is of particular interest to write structures that have low scattering and high optical quality (paragraph 0146). Knox et al. disclose correcting higher-order aberrations to minimize the effects of “rainbow,” which is a diffraction-based effect, where structures having reduced line spacing to 0.7 to 0.5 microns reduces the “rainbow” effect (paragraph 0152).
It would have been obvious to one of ordinary skill to further modify the collagenous lenticule of Soker et al. and Elisseeff et al. by correcting aberrations to minimize scattering as suggested by Knox et al., thereby arriving at the claimed scattering angles by routine optimization (instant claims 42, 53-55). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this instance, Knox et al. disclose correcting ocular tissues to optimize vision by minimizing or reducing scattering. Therefore, it would have been obvious to arrive at the claimed scattering angel of less than 4 arcminutes because the prior art discloses reducing scattering for optimal vision.
Reply: Applicant’s amendments/remarks have been considered but they are not persuasive. The reasons for maintaining Soker et al. and Elisseeff et al. are the same as noted above. Soker et al. and Elisseeff et al. can be deemed to disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule.
Regarding Applicant’s remarks that Knox et al. is not concerned with lenticules formed of corneal tissue for intracorneal implantation, much less with reducing light scattering associated with such lenticules, the remarks are not persuasive. The deficiency of Knox et al. to not teach lenticules formed of corneal tissue for intracorneal implantation are reasonably remedied by at least Soker et al. and Elisseeff et al. for the reasons already noted above.
Regarding Applicant’s remarks that Knox et al. disclose forming a refractive suture in a living eye, the remarks are not persuasive. Knox et al. disclose minimizing scattering in ocular tissue, and reasonably disclose extracted cornea can be corrected and optimized (see at least examples disclosed in Knox et al.). Therefore, Knox et al. reasonably disclose that cornea in general can be corrected and/or optimized for vision.
Claims 31, 32, 43, 52, 70, 72 are rejected under 35 U.S.C. 103 as being unpatentable over Soker et al. (US 20100215717; IDS 08.01.19, previously cited) in view of Elisseeff et al. (US 20180228599; IDS 07.17.24), and Patel II (WO 2016178586; IDS 08.04.21, previously cited). The teachings of Soker et al. and Elisseeff et al. over at least instant claims 31, 52 are noted above. As noted above, Soker et al. and Elisseeff et al. disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule, where the decellularized collagenous lenticule comprises a decellularized lenticular body derived from donor corneal tissue that has been partially compacted and at least partially cross-linked, wherein the collagen content and structure are substantially retained as exhibited in the donor corneal source and exhibits sufficient optical clarity for use in intracorneal implantation.
Regarding instant claim 32, Patel II discloses a collagenous lenticule having an aligned and lamellar collagen structure, and retaining a high degree of transparency (at least paragraph 00266), where the collagen may originate from human, animal or recombinant sources (paragraph 00142). In addition to the crosslinking agent disclosed in Elisseeff et al., Patel II discloses crosslinking of the collagen composition can also be achieved by radiation (paragraph 00161). It would have been obvious to one of ordinary skill that crosslinking by radiation can be further incorporated as a crosslinking means in the collagen layers of the decellularized collagenous lenticule of Soker et al. and Elisseeff et al. above, comprising a decellularized lenticular body derived from donor corneal tissue that has been partially compacted and at least partially cross-linked, wherein the collagen content and structure are substantially retained as exhibited in the donor corneal source and exhibits sufficient optical clarity for use in intracorneal implantation, thereby arriving at the claimed invention. One of ordinary skill would have a reasonable expectation of success because it was recognized in the prior art that a collagenous lenticule comprising collagen fibrils can alternatively be crosslinked by radiation.
Regarding instant claim 43, Patel II also disclose that the collagenous lenticule can also be depleted of fluid (at least paragraph 00160). Therefore, it would have been obvious that fluid depletion can be incorporated in the decellularized collagenous lenticule of Soker et al. and Elisseeff et al. above, comprising a decellularized lenticular body derived from donor corneal tissue that has been partially compacted and at least partially cross-linked, wherein the collagen content and structure are substantially retained as exhibited in the donor corneal source and exhibits sufficient optical clarity for use in intracorneal implantation, thereby arriving at the claimed invention. One of ordinary skill would have a reasonable expectation of success because it is disclosed in the prior art that fluid depletion can be incorporated into a collagenous lenticule having an aligned and lamellar collagen structure, and retaining a high degree of transparency (Patel II).
Regarding instant claims 70, 72, Patel II discloses crosslinking of the collagen composition also by actinic radiation producing a radiant energy 5.4 J/cm2 (at least paragraph 00214). It is known that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05. In this instance, it would have been obvious to arrive at crosslinking by actinic radiation having a fluence in a range of about 100 to about 5000 Joules per square centimeter by routine optimization.
Reply: Applicant’s amendments/remarks have been considered but they are not persuasive. The reasons for maintaining Soker et al. and Elisseeff et al. are the same as noted above. Soker et al. in view of Elisseeff et al. can be deemed to disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule.
Claims 31, 44 are rejected under 35 U.S.C. 103 as being unpatentable over Soker et al. (US 20100215717; IDS 08.01.19, previously cited) in view of Elisseeff et al. (US 20180228599; IDS 07.17.24), and WO ‘045 (WO 2018219045; IDS 08.04.21, previously cited) (translated copy cited herein). The teachings of Soker et al. and Elisseeff et al. over at least instant claim 31 is noted above. As noted above, Soker et al. and Elisseeff et al. disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule, where the decellularized collagenous lenticule comprises a decellularized lenticular body derived from donor corneal tissue that has been partially compacted and at least partially cross-linked, wherein the collagen content and structure are substantially retained as exhibited in the donor corneal source and exhibits sufficient optical clarity for use in intracorneal implantation.
Regarding instant claim 44, WO ‘045 discloses a decellularized collagenous lenticule that is cross-linked and sterilized (at least paragraph 0014). WO ‘045 discloses the decellularized collagenous lenticule that is crosslinked has higher safety, better transparency, and a more stable performance (at least paragraphs 0013, 0040). WO ‘045 discloses sterilizing the collagenous lenticule by radiation (at least paragraph 0028). It would have been obvious to one of ordinary skill to further sterilize by radiation the decellularized collagenous lenticule of Soker et al. in view of Elisseeff et al. above, comprising a decellularized lenticular body derived from donor corneal tissue that has been partially compacted and at least partially cross-linked, wherein the collagen content and structure are substantially retained as exhibited in the donor corneal source and exhibits sufficient optical clarity for use in intracorneal implantation, thereby arriving at the claimed invention. One of ordinary skill would have a reasonable expectation of success because it was recognized in the prior art that a decellularized collagenous lenticule comprising collagen fibrils can be sterilized for higher safety and more stable performance.
Reply: Applicant’s amendments/remarks have been considered but they are not persuasive. The reasons for maintaining Soker et al. and Elisseeff et al. are the same as noted above. Soker et al. in view of Elisseeff et al. can be deemed to disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule.
Claims 31, 37, 63-64, 68, 73 are rejected under 35 U.S.C. 103 as being unpatentable over Soker et al. (US 20100215717; IDS 08.01.19, previously cited) in view of Elisseeff et al. (US 20180228599; IDS 07.17.24), and Xu et al. (US 20150126453; previously cited). The teachings of Soker et al. and Elisseeff et al. over at least instant claim 31 is noted above. As noted above, Soker et al. and Elisseeff et al. disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule, where the decellularized collagenous lenticule comprises a decellularized lenticular body derived from donor corneal tissue that has been partially compacted and at least partially cross-linked, wherein the collagen content and structure are substantially retained as exhibited in the donor corneal source and exhibits sufficient optical clarity for use in intracorneal implantation.
Regarding instant claims 37, 63, Xu et al. disclose donor tissues can comprise alpha-gal epitopes causing increased immune responses in the recipient (at least paragraphs 0001-0004). Xu et al. disclose removing alpha-gal epitopes from a tissue product prior to transplantation by exposing the tissue product to an enzyme (at least paragraph 0026). Xu et al. disclose the tissue product can comprise any tissue suitable for implantation, including neural connective tissue, neurological tissue, etc., where the tissue is decellularized (at least paragraphs 0029, 0037, 0042). It would have been obvious to one of ordinary skill to further remove immunogenic epitopes to reduce immunoreactivity of the decellularized collagenous lenticule of Soker et al. in view of Elisseeff et al. above, comprising a decellularized lenticular body derived from donor corneal tissue that has been partially compacted and at least partially cross-linked, wherein the collagen content and structure are substantially retained as exhibited in the donor corneal source and exhibits sufficient optical clarity for use in intracorneal implantation, thereby arriving at the claimed invention. One of ordinary skill would have a reasonable expectation of success because it was recognized in the prior art that immunogenic epitopes on decellularized tissue for implantation can be removed to reduce immunoreactivity.
Regarding instant claims 63-64, for the reasons already noted above for at least instant claims 31 and 52, it would be obvious to arrive at the claimed collagenous lenticule. Further, regarding the instant limitation that the lenticular body comprising collagen fibrils have been “compacted along a direction generally perpendicular to the collagen lamellar structure to exhibit a collagen concentration greater than 30%” in a state of full equilibrium with water, it is disclosed in the instant specification that “compression” encompasses compaction by application of pressure or by other techniques such as vacuum or centrifugal force-driven water extraction (paragraph 0068 of the application publication). As noted above, Elisseeff et al. disclose compressing and drying the decellularized cornea in a mold prior to crosslinking the decellularized cornea that is compressed or compacted in the mold (Fig. 27); therefore, Elisseeff et al. can be deemed to disclose compaction along a direction generally perpendicular to the collagen structure. It is further known that the amount of collagen in cornea equates to approximately 68% dry weight of the cornea (Soker et al. at least paragraph 0037). Therefore, Soker et al. in view of Elisseeff et al. can be deemed to disclose the decellularized corneal lenticule comprises “compacted” collagen exhibiting a collagen concentration greater than 30% (instant claim 63) or greater than 45% (instant claim 64), where the decellularized corneal lenticule is for intracorneal or intrastromal implantation, and such that the decellularized corneal lenticule exhibits the recited collagen concentrations of at least 30% or greater than 45%, when the collagen concentration is “measured as a fractional weight of the lenticule in a desiccated state relative to a weight of the lenticule in a state in full equilibrium with water”.
Regarding instant claim 68, Elisseeff et al. disclose shaping the decellularized cornea for contour and thickness (at least paragraph 0087) and the specific concaved shape of cornea generates the refractive power to assure visual acuity (at least paragraph 0108). Soker et al. disclose a collagenous lenticule comprising a lenticular body derived from human cornea tissue for implantation (at least paragraphs 0008-0010). Soker et al. disclose the lenticule has a thickness of between 50 and 200 micrometers (paragraph 0008) and a diameter of 8 mm (paragraph 0067). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the references and arrive at the claimed collagenous lenticule having a disc-like shape, a diameter of about 8 mm, and a thickness of between 50-200 micrometers (instant claim 68). The motivation to do so is given by the prior art. Elisseeff et al. disclose shaping the decellularized cornea for contour and thickness (at least paragraph 0087) and the specific concaved shape of cornea generates the refractive power to assure visual acuity (at least paragraph 0108). It is disclosed that collagenous lenticules derived from cornea tissue for implantation can have a thickness of between 50 and 200 micrometers and a diameter of about 8 mm (Soker et al.). Therefore, one of ordinary skill would have reasonable motivation to shape the thickness and/or diameter of the decellularized collagenous lenticule from donor corneal tissue where the lenticule has a thickness of between 50 and 200 micrometers and a diameter of 8 mm. One of ordinary skill would have a reasonable expectation of success because it is disclosed that a collagenous lenticule can be designed to have the dimensions including a thickness of 50 and 200 micrometers and a diameter of 8 mm for corneal implantation, including intrastromal implantation.
Regarding instant claim 73, Elisseeff et al. also disclose that collagen crosslinking increases the tensile strength of the cornea (at least paragraph 0080) and occurs with UV-A light (at least paragraph 0080) and/or UV radiation (at least paragraph 0084).
Reply: Applicant’s amendments/remarks have been considered but they are not persuasive. The reasons for maintaining Soker et al. and Elisseeff et al. are the same as noted above. Soker et al. in view of Elisseeff et al. can be deemed to disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule.
Claims 63-64, 68, 73-74 are rejected under 35 U.S.C. 103 as being unpatentable over Soker et al. (US 20100215717; IDS 08.01.19, previously cited) in view of Elisseeff et al. (US 20180228599; IDS 07.17.24), Xu et al. (US 20150126453; previously cited), and Patel II (WO 2016178586; IDS 08.04.21, previously cited). The teachings of Soker et al., Elisseeff et al., and Xu et al. over at least instant claim 63 is noted above. As noted above, Soker et al., Elisseeff et al., and Xu et al. disclose a decellularized collagenous lenticule that is materially and structurally similar to the claimed collagenous lenticule, where the decellularized collagenous lenticule comprises a decellularized lenticular body derived from donor corneal tissue that has been partially compacted and at least partially cross-linked, wherein the collagen content and structure are substantially retained as exhibited in the donor corneal source and exhibits sufficient optical clarity for use in intracorneal implantation, and wherein immunogenic epitopes to reduce immunoreactivity have been removed.
Regarding instant claim 74, Patel II discloses crosslinking of the collagen composition also by actinic radiation producing a radiant energy 5.4 J/cm2 (at least paragraph 00214). It is known that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05. In this instance, it would have been obvious to arrive at crosslinking by actinic radiation having a fluence in a range of about 100 to about 5000 Joules per square centimeter by routine optimization.
Reply: Applicant’s amendments/remarks have been considered but they are not persuasive. The reasons for maintaining Soker et al. and Elisseeff et al. are the same as noted above.
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 Marsha Tsay whose telephone number is (571)272-2938. The examiner can normally be reached on M-F.
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/Marsha Tsay/Primary Examiner, Art Unit 1656