DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/14/2026 has been entered.
Claims 31, 32, 39-40, 57, 59, 61-66 and 74-75 are pending, all of which have been considered on the merits.
Allowable Subject Matter
Upon reconsideration, the allowability of the subject matter of claims 59 and 66 is regrettably withdrawn.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 1, 8-10, 12, 40*, 62-65, 69-73 under 35 USC 112, second paragraph:
*claim 40 was not included in the rejection heading, but was specifically rejected. Cancellation of claims 1, 8-10, 12 and 69-73 render the rejection of these claims moot.
The amendment to claim 40 obviates the previous basis of rejection, but a new ground of rejection has been necessitated.
The amendment to claims 62-65 obviate the previous basis of rejection. The rejection is withdrawn.
RE: Rejection of claims 1, 8-10, 12 and 69-73 under 35 USC 112, first paragraph, as failing to comply with the enablement requirement:
Cancellation of claims 1, 8-10, 12 and 69-73 renders the rejection of these claims moot.
RE: Rejection of claims 40 and 57 under 35 USC 102(b) over Ma et al:
Claim 40 has been amended to require that at least 90% of the ‘total cell population’ is ABCB5+ limbal stem cells. While there is an indefinite issue with regards to which cell population is being limited (See rejection under 35 USC 112, second paragraph, below), as noted by Applicants, there is no information available about the % of ABCB5+ limbal stem cells in the graft produced by Ma et al. Therefore, it cannot be held that the limbal stem cell population seeded by Ma et al, or the overall cell population present on the graft, contain at least 90% ABCB5+ limbal stem cells. The rejection is withdrawn.
Claim 57 has been amended to require that at least 90% of the total cell population [present on the in vitro substrate] are ABCB5+ limbal stem cells. As noted above, Applicants have persuasively argued that no information is available about the % of ABCB5+ limbal stem cells present in the limbal stem cell population used by Ma et al. Therefore the rejection is withdrawn.
RE: Rejection of claims 1, 8-10, 12, 31, 32, 39, 40, 57, 60 and 69-73 over claims of US Patent 9801912:
A terminal disclaimer has been filed over US Patent 9801912. The terminal disclaimer has been approved and recorded. The rejection is withdrawn.
Claim Interpretation
The application is generally directed to use of ABCB5+ limbal stem cells. The following points are made of record to assist in understanding the scope of the claims:
Not all ABCB5+ cells are limbal stem cells. ABCB5 is a marker found on a number of cell types, including limbal stem cells, retinal pigment stem cells, stem cells found in central cornea, mesenchymal stem cells from a variety of sources, including skin, and some cancer stem cells (See instant specification, Ksander et al (Nature, 2014), Frank US Patent 8455245, Thill et al (Melanoma Research, 2011)).
ABCB5+ ocular stem cells will include, inter alia, ABCB5+ limbal stem cells, ABCB5+ retinal pigment stem cells, ABCB5+ stem cells from central cornea region, and ABCB5+ mesenchymal stem cells derived from the eye.
Not all ocular stem cells, nor all limbal stem cells, are ABCB5+. This is supported by the fact that ABCB5 knock out mice (i.e. all cells lack expression of ABCB5) still have some limbal stem cells and central corneal cells (See Ksander et al, id). Thus, ABCB5+ ocular stem cells is a subpopulation of ocular stem cells, and ABCB5+ limbal stem cells is a subpopulation of limbal stem cells
“Isolation” of a particular cell type will be interpreted to mean that no cells not meeting the requirement are present. E.g. ‘An isolated population of ABCB5+ limbal stem cells’ means no ABCB5- limbal stem cells are present, nor any non-limbal stem cells, are present.
“Enrichment” of a particular cell type will be interpreted to mean that the concentration of said cell type in a population has been increased relative to its native concentration. Enrichment can be achieved by removing non-target cells or by adding in additional target cells. E.g. ‘An enriched population of ABCB5(+) limbal stem cells’ means that the number of ABCB5+ limbal stem cells in the population is greater than the native concentration in the population.
In light of the above points, the claims are interpreted as follows:
Claim 31 is directed to a method of producing an ocular graft for transplantation into a subject. The method comprises a single active step of seeding a substrate with isolated ocular ABCB5+ limbal stem cells to produce the ocular graft. The specification defines “ocular graft for transplantation” as a substrate containing ACBC5+ stem cells and optionally other ocular cells and bioactive factors that promote ocular cell regeneration, which substrate may be transplanted to or implanted into an eye of a subject to replace damaged or infected tissue (See Pg. 20 of as-filed spec). There are no specific structural or construction details beyond ‘capable of being transplanted to or implanted into an eye.” In light of the definition in the specification, the preamble ‘breathes life into the claim’ in so far as it requires that the method result in production of a graft that is suitable for transplantation to or implantation into an eye of a subject. However, actual transplantation and/or implantation is not required by claim 31. Noting that the claim requires seeding of the substrate with isolated ABCB5+ limbal stem cells, it is interpreted that no other cells will be seeded along with the ABCB5+ limbal stem cells.
Claim 32 requires further administration of the substrate (i.e. the ocular graft) into a subject. Claim 32 further defines the limbal stem cells as allogeneic stem cells. This is understood to mean the stem cells are allogeneic to the recipient of the ocular graft.
Claims 74 and 75 describe the manner in which the ABCB5+ ocular stem cells are obtained. These are product-by-process limitations. Product-by-process limitations are considered only in so far as the method of production affects the final product. In this case, the manner in which ABCB5+ limbal stem cells are isolated does not change the biochemistry or phenotype of the ABCB5+ limbal stem cells. If Applicants intend for the steps of isolation to be required steps of the method, then the claims should be amended to say “wherein the method further comprises separating …” or the like.
Claim 40 is directed to an ocular graft for transplantation into a subject. As above, the specification defines “ocular graft for transplantation” as a substrate containing ABCB5+ stem cells and optionally other ocular cells and bioactive factors that promote ocular cell regeneration, which substrate may be transplanted to or implanted into an eye of a subject to replace damaged or infected tissue (See Pg. 20 of as-filed spec). There are no specific structural or construction details beyond ‘capable of being transplanted to or implanted into an eye.”
Claim 40 requires the ocular graft is enriched with isolated ABCB5+ stem cells, wherein the isolated ABCB5+ stem cells are a population of ABCB5+ ocular stem cells enriched for ABCB5+ limbal stem cells. The italicized language obfuscates the metes and bounds of the claim. A rejection is made under 35 USC 112, second paragraph, (See below). For purposes of compact prosecution, an attempt at discerning the metes and bounds of the claim is hereby made of record:
The claim is interpreted as being drawn to a composition comprising (i) a substrate material that is transplantable to or implantable into an eye, and (ii) ABCB5+ limbal stem cells in an amount greater than they would natively be found on the substrate, and wherein at least 90% of the total cell population present in the composition are ABCB5+ limbal stem cells. It is noted that if the substrate is non-corneal or limbus tissue, then the presence of even a single ABCB5+ limbal stem cell will satisfy the requirement of ABCB5+ limbal stem cells present in an amount greater than they would natively be found on the substrate. If Applicants intend for a different scope, then such must be made clear via amendment.
Claim 57 is drawn to an in vitro substrate, comprising an artificial cornea substrate seeded with a population of cells enriched with isolated ABCB5+ limbal stem cells. There is no definition for ‘artificial cornea’ in the instant application. Thus, in giving the term its broadest reasonable interpretation, any substantially planar material that is transplantable to or implantable into an eye will be considered to satisfy definition of ‘an artificial cornea’. It is noted “artificial cornea substrate” is slightly narrower than “ocular graft” because an artificial cornea substrate will have a substantially planar structure (as a cornea is generally planar). If Applicants intend for a different scope, then such must be made clear via amendment.
The claim requires the artificial cornea to be seeded with a population of cells enriched with isolated ABCB5+ limbal stem cells. This is interpreted as meaning the final composition must have a concentration of ABCB5(+) limbal stem cells greater than the native number of ABCB5(+) limbal stem cells found on the substrate. If the substrate is a non-corneal tissue, and specifically a non-limbus tissue, then even a single ocular ABCB5(+) limbal stem cell will satisfy this limitation. Other cells (including ABCB5- limbal stem cells and ABCB5+ non-limbal stem cells) can also be present.
Overall, the claim is interpreted as being drawn to an in vitro substrate comprising (i) a substantially planar material that is transplantable to or implantable into an eye, and (ii) ABCB5+ limbal stem cells in an amount greater than they would natively be found on the substrate, and wherein at least 90% of the total cell population of the substrate be ABCB5+ limbal stem cells.
Claim 59 is drawn to an in vitro substrate, comprising an artificial cornea substrate seeded with a population of cells enriched with isolated ABCB5+ retinal stem cells. As above, there is no definition for ‘artificial cornea’ in the instant application. Thus, in giving the term its broadest reasonable interpretation, any substantially planar material that is transplantable to or implantable into an eye will be considered to satisfy definition of ‘an artificial cornea’. The claim requires the artificial cornea to be seeded with a population of cells enriched with isolated ABCB5+ retinal stem cells. This is interpreted as meaning the final graft must have a concentration of ABCB5(+) retinal stem cells greater than the native number of ABCB5(+) retinal stem cells on the substrate. If the substrate is a non-retinal tissue, then even a single ocular ABCB5(+) retinal stem cell will satisfy this limitation. Other cells (including ABCB5- retinal stem cells and ABCB5+ non-retinal cells) can also be present.
Overall, the claim is interpreted as being drawn to an in vitro substrate comprising (i) a substantially planar material that is transplantable to or implantable into an eye, and (ii) ABCB5+ retinal stem cells.
Dependent claims 62-65 define the % of the cell population that must be ABCB5+ retinal stem cells.
Claim 61 is drawn to an in vitro substrate, comprising an artificial cornea substrate seeded with a population of cells enriched with isolated ABCB5+ limbal stem cells, and further comprising central corneal cells. As above, there is no definition for ‘artificial cornea’ in the instant application. Thus, in giving the term its broadest reasonable interpretation, any substantially planar material that is transplantable to or implantable into an eye will be considered to satisfy definition of ‘an artificial cornea’. The claim requires the artificial cornea to be seeded with a population of cells enriched with isolated ABCB5+ limbal stem cells. This is interpreted as meaning the final composition must have a concentration of ABCB5(+) limbal stem cells greater than the native number of ABCB5(+) limbal stem cells on the substrate. If the substrate is a non-corneal tissue, then even a single ocular ABCB5(+) limbal stem cell will satisfy this limitation. Other cells (including ABCB5- retinal stem cells and ABCB5+ non-retinal cells) can also be present. Cells of the central cornea must also be present. It is noted that limbal stem cells are from the limbus, not from the central cornea.
Overall, the claim is interpreted as being drawn to an in vitro substrate comprising (i) a substantially planar material that is transplantable to or implantable into an eye, (ii) ABCB5+ limbal stem cells, and (iii) central corneal cells.
New Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 40 is rejected under 35 U.S.C. 112(b), or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 40 is directed to an ocular graft for transplantation into a subject.
Claim 40 requires the ocular graft is enriched with isolated ABCB5+ stem cells, wherein the isolated ABCB5+ stem cells are a population of ABCB5+ ocular stem cells enriched for ABCB5+ limbal stem cells. The definitions for “isolated” and “enriched” are set forth above. The combination and arrangement of the terms in the claim is found to obfuscate what actual cells are, and are not, present on/in claimed graft.
An isolated population of ABCB5+ ocular stem cells will consist of ABCB5+ ocular stem cells.
A graft enriched with this isolated population means the graft will contain the ABCB5+ ocular stem cells at a greater than native concentration on the graft, but other cells may also be present.
The issue at hand is the claim further defines the isolated population of ABCB5+ ocular stem cells as being enriched with ABCB5+ limbal stem cells. It is not clear how this limits the cell population present on the ultimately claimed graft. ABCB5+ ocular stem cells are a genus of cell types, they cover at least ABCB5+ limbal stem cells and ABCB5+ retinal stem cells. However, there is no native reservoir or niche for all types of ABCB5+ ocular stem cells. Rather, the different cell types are present in different tissues (e.g. the cornea vs the retinal). It is thus unclear how an isolated population of ABCB5+ ocular stem cells is enriched for ABCB5+ limbal stem cells. As above “enriched” is interpreted as meaning present at a greater than native concentration, however, when dealing with a heterogeneous population of cells that does not exist together in nature, it is unclear what proportion or level of ABCB5+ limbal stem cells must be present in order to be considered enriched. Enriched relative to what? Enriched relative to starting heterogenous mixture does not have meaning if the starting heterogenous mixture is undefined.
Furthermore, the claim states that at least 90% of the total cell population is ABCB5+ limbal stem cells. It is unclear if the ‘total cell population’ is the overall cell population in the graft or the isolated population of ABCB5+ ocular stem cells.
The metes and bounds of what cells are present on the graft, and in what amounts, cannot be determined. The claim is therefore indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 40, 57, 59, and 61-66 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to a product of nature judicial exception without significantly more.
The claims have been analyzed in accordance with their broadest reasonable interpretation.
Regarding claim 40: For this analysis claim 40 is interpreted as being drawn to a composition comprising (i) a substrate material that is transplantable to or implantable into an eye, and (ii) ABCB5+ limbal stem cells in an amount greater than they would natively be found on the substrate, and wherein at least 90% of the total cell population present on the graft are ABCB5+ limbal stem cells. The claim covers embodiments where 100% of the cells in the composition are ABCB5+ limbal stem cells.
The claim is directed to a composition of matter, which is a statutory category of invention (Step 1: YES).
The claim recites at least one nature-based product, i.e. an ABCB5+ limbal stem cell. Ksander et al (Nature, 2014) evidences that ABCB5+ limbal stem cells are naturally occurring cell type present in the basal limbal epithelium of a human eye. The ABCB5+ limbal stem cells present in the graft are identical (no difference in characteristics) to naturally occurring ABCB5+ limbal stem cells. Because there is no difference between the claimed and naturally occurring ABCB5+ limbal stem cells, the claimed ABCB5+ limbal stem cells do not have markedly different characteristics and are thus a “product of nature” exception. See In re Roslin Institute (Edinburg), 750 F. 3d 1333, 1338-39 (Fed Cir 2014). Accordingly, the claim recites a judicial exception (Step 2A, prong 1: YES).
Based on the definition of ‘ocular graft’ the claimed product does require a substrate material that is transplantable or implantable into an eye, which is an element in addition to the cells (the judicial exception). The claims do not limit or define the substrate beyond ‘physically capable of being transplantable to or implantable into an eye’. The substrate may be a naturally occurring material in and of itself, or it may be a non-naturally occurring substrate. The substrate encompassed by the claim includes, inter alia, amnion, compressed collagen, or even synthetic biocompatible polymer films. There is no indication or requirement that the cells are transformed or change any state when combined with the substrate material. Therefore, the combination of cells on a generically described substrate sheet is not considered integrated into a practical application, as it does not affect a transformation or reduction of a particular article to a different state or thing (Step 2A, prong 2: NO).
As above, due to the definition of ‘ocular graft’ the claimed product does require a substrate material that is transplantable or implantable into an eye, which is an element in addition to the cells (the judicial exception). The claims do not limit or define the substrate beyond ‘physically capable of being transplantable to or implantable into an eye’. The substrate may be a naturally occurring material in and of itself, or it may be a non-naturally occurring substrate. The substrate encompassed by the claim includes, inter alia, amnion, compressed collagen, or even synthetic biocompatible polymer films. In general, at the time the invention was made, it was considered well-understood, routine and conventional to provide limbal stem cells on a substrate that is capable of being implanted into the eye (See, e.g. Ma et al (Stem Cells, 2006), who teaches providing limbal stem cells on amniotic membrane (See abstract); and Connon (WO 2010/133853), who teaches providing compacted collagen gel as a substrate for corneal limbal epithelial cells (See abstract)). Therefore, while the substrate is an element in addition to the judicial exception, the substrate does not add significantly more to the judicial exception (Step 2B: NO). Therefore claim 40 is patent ineligible.
Regarding claim 57: Claim 57 is interpreted as being drawn to an in vitro substrate comprising (i) a substantially planar material that is transplantable to or implantable into an eye, and (ii) ABCB5+ limbal stem cells in an amount greater than they would natively be found on the substrate, and wherein at least 90% of the total cell population of the substrate be ABCB5+ limbal stem cells. The claim covers embodiments where 100% of the cells in the composition are ABCB5+ limbal stem cells.
The claim is directed to a composition of matter, which is a statutory category of invention (Step 1: YES).
The claim recites at least one nature-based product, i.e. an ABCB5+ limbal stem cell. Ksander et al (Nature, 2014) evidences that ABCB5+ limbal stem cells are naturally occurring cell type present in the basal limbal epithelium of a human eye. The ABCB5+ limbal stem cells present in the graft are identical (no difference in characteristics) to naturally occurring ABCB5+ limbal stem cells. Because there is no difference between the claimed and naturally occurring ABCB5+ limbal stem cells, the claimed ABCB5+ limbal stem cells do not have markedly different characteristics and are thus a “product of nature” exception. See In re Roslin Institute (Edinburg), 750 F. 3d 1333, 1338-39 (Fed Cir 2014). Accordingly, the claim recites a judicial exception (Step 2A, prong 1: YES).
The claimed product does require an artificial corneal substrate, which is interpreted as a substantially planar substrate material that is transplantable or implantable into an eye, which is an element in addition to the cells (the judicial exception). The artificial corneal substrate may be a naturally occurring material in and of itself, or it may be a non-naturally occurring substrate. The artificial corneal substrate encompassed by the claim includes, inter alia, amnion, compressed collagen, or even synthetic biocompatible polymer films. There is no indication or requirement that the cells are transformed or change any state when combined with the substrate material. Therefore, the combination of cells on a generically described artificial corneal substrate sheet is not considered integrated into a practical application, as it does not affect a transformation or reduction of a particular article to a different state or thing (Step 2A, prong 2: NO).
As above, the claimed product does require an artificial corneal substrate, which is interpreted as a substantially planar substrate material that is transplantable or implantable into an eye, which is an element in addition to the cells (the judicial exception). The artificial corneal substrate may be a naturally occurring material in and of itself, or it may be a non-naturally occurring substrate. The artificial corneal substrate encompassed by the claim includes, inter alia, amnion, compressed collagen, or even synthetic biocompatible polymer films. In general, at the time the invention was made, it was considered well-understood, routine and conventional to provide limbal stem cells on a substrate that is capable of being implanted into the eye (See, e.g. Ma et al (Stem Cells, 2006), who teaches providing limbal stem cells on amniotic membrane (See abstract); and Connon (WO 2010/133853), who teaches providing compacted collagen gel as a substrate for corneal limbal epithelial cells (See abstract)). Therefore, while the substrate is an element in addition to the judicial exception, the substrate does not add significantly more to the judicial exception (Step 2B: NO). Therefore claim 57 is patent ineligible.
Regarding claims 59 and 62-66: Claim 59 is interpreted as an in vitro substrate comprising (i) a substantially planar material that is transplantable to or implantable into an eye, and (ii) ABCB5+ retinal stem cells.
The claims covers embodiments where 100% of the cells in the composition are ABCB5+ retinal stem cells.
The claim is directed to a composition of matter, which is a statutory category of invention (Step 1: YES).
The claim recites at least one nature-based product, i.e. an ABCB5+ retinal stem cell. Ksander et al (IOVS, 2016) evidences that ABCB5+ retinal pigment epithelial stem cells are naturally occurring cell type present in the eye. The ABCB5+ RPE stem cells present in the graft are identical (no difference in characteristics) to naturally occurring ABCB5+ RPE stem cells. Because there is no difference between the claimed and naturally occurring ABCB5+ RPE stem cells, the claimed ABCB5+ RPE stem cells do not have markedly different characteristics and are thus a “product of nature” exception. See In re Roslin Institute (Edinburg), 750 F. 3d 1333, 1338-39 (Fed Cir 2014). Accordingly, the claim recites a judicial exception (Step 2A, prong 1: YES).
The claimed product does require an artificial corneal substrate, which is interpreted as a substantially planar substrate material that is transplantable or implantable into an eye, which is an element in addition to the cells (the judicial exception). The artificial corneal substrate may be a naturally occurring material in and of itself, or it may be a non-naturally occurring substrate. The artificial corneal substrate encompassed by the claim includes, inter alia, amnion, compressed collagen, or even synthetic biocompatible polymer films. There is no indication or requirement that the cells are transformed or change any state when combined with the substrate material. Therefore, the combination of cells on a generically described artificial corneal substrate sheet is not considered integrated into a practical application, as it does not affect a transformation or reduction of a particular article to a different state or thing (Step 2A, prong 2: NO).
As above, the claimed product does require an artificial corneal substrate, which is interpreted as a substantially planar substrate material that is transplantable or implantable into an eye, which is an element in addition to the cells (the judicial exception). The artificial corneal substrate may be a naturally occurring material in and of itself, or it may be a non-naturally occurring substrate. The artificial corneal substrate encompassed by the claim includes, inter alia, amnion, compressed collagen, or even synthetic biocompatible polymer films. In general, at the time the invention was made, it was considered well-understood, routine and conventional to provide ocular cells on a substrate that is capable of being implanted into the eye (See, e.g. Ma et al (Stem Cells, 2006), who teaches providing limbal stem cells on amniotic membrane (See abstract); and Connon (WO 2010/133853), who teaches providing compacted collagen gel (which reads on acellular collagen) as a substrate for corneal limbal epithelial cells (See abstract)). Therefore, while the substrate is an element in addition to the judicial exception, the substrate does not add significantly more to the judicial exception (Step 2B: NO). Therefore claims 59 and 62-66 are patent ineligible.
Regarding claim 61: Claim 61 is interpreted as being drawn to an in vitro substrate comprising (i) a substantially planar material that is transplantable to or implantable into an eye, (ii) ABCB5+ limbal stem cells, and (iii) central corneal cells. The ABCB5+ limbal stem cells and central corneal cells can constitute 100% of the cells present in the product.
The claim is directed to a composition of matter, which is a statutory category of invention (Step 1: YES).
The claim recites at least one nature-based product, i.e. an ABCB5+ limbal stem cell. Ksander et al (Nature, 2014) evidences that ABCB5+ limbal stem cells are naturally occurring cell type present in the basal limbal epithelium of a human eye. The ABCB5+ limbal stem cells present in the graft are identical (no difference in characteristics) to naturally occurring ABCB5+ limbal stem cells. Because there is no difference between the claimed and naturally occurring ABCB5+ limbal stem cells, the claimed ABCB5+ limbal stem cells do not have markedly different characteristics and are thus a “product of nature” exception. See In re Roslin Institute (Edinburg), 750 F. 3d 1333, 1338-39 (Fed Cir 2014). Accordingly, the claim recites a judicial exception (Step 2A, prong 1: YES).
The claimed product does require central corneal cells in addition to the ABCB5+ limbal stem cells. Central corneal cells covers any cell from the central corneal region. They, too, are products of nature. The inclusion of a second naturally occurring cell type does not integrate the ABCB5+ limbal stem cells into a practical application, as there is no required or recited interaction between the cells that would result in a transformation or alteration in either cell ty pe.
The claimed product also requires an artificial corneal substrate, which is interpreted as a substantially planar substrate material that is transplantable or implantable into an eye, which is an element in addition to the cells (the judicial exception). The artificial corneal substrate may be a naturally occurring material in and of itself, or it may be a non-naturally occurring substrate. The artificial corneal substrate encompassed by the claim includes, inter alia, amnion, compressed collagen, or even synthetic biocompatible polymer films. There is no indication or requirement that the cells are transformed or change any state when combined with the substrate material. Therefore, the combination of cells on a generically described artificial corneal substrate sheet is not considered integrated into a practical application, as it does not affect a transformation or reduction of a particular article to a different state or thing (Step 2A, prong 2: NO).
As above, the claimed product does require an artificial corneal substrate, which is interpreted as a substantially planar substrate material that is transplantable or implantable into an eye, which is an element in addition to the cells (the judicial exception). The artificial corneal substrate may be a naturally occurring material in and of itself, or it may be a non-naturally occurring substrate. The artificial corneal substrate encompassed by the claim includes, inter alia, amnion, compressed collagen, or even synthetic biocompatible polymer films. In general, at the time the invention was made, it was considered well-understood, routine and conventional to provide limbal stem cells on a substrate that is capable of being implanted into the eye (See, e.g. Ma et al (Stem Cells, 2006), who teaches providing limbal stem cells on amniotic membrane (See abstract); and Connon (WO 2010/133853), who teaches providing compacted collagen gel as a substrate for corneal limbal epithelial cells (See abstract)). Therefore, while the substrate is an element in addition to the judicial exception, the substrate does not add significantly more to the judicial exception (Step 2B: NO). Therefore claim 61 is patent ineligible.
Allowable Subject Matter
Claims 31, 32, 39, 74 and 75 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 EST.
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/ALLISON M FOX/Primary Examiner, Art Unit 1633
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