DETAILED ACTION
This action is in reply to papers filed 8/26/2024. Claims 26-41 were pending and examined herein.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20240402171A1, Published 8/7/2026.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 26--31 and 38-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12072334. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Instant claim 26 is drawn to a method for determining the fibroblastic status of a corneal endothelial cell, comprising: (a) contacting a sample comprising the corneal endothelial cell with one or more detection agents selected from: (i) one or more detection agents selective for a cell-surface marker of corneal endothelial cells with a non-fibroblastic phenotype selected from the group consisting of CD166, HLA-A2, CD66a, CD66c, CD66d, CD66e, CD98, CD59, CD54, CD340, CD47, EGF-R, CD29, CD74, CD165, CD221, CD49a, SSEA-4, CD130, and CD49f, and (ii) one or more detection agents selective for a cell-surface marker of corneal endothelial cells with a fibroblastic phenotype selected from the group consisting of CD26, CD9, CD49b, CD49e, CD13, CD99, CD105, CD63, CD58, CD201, CD56, CD44, CD55, CD71, CD73, CD91, HLA-DQ, CD164, CD49d, CD49c, CD90, MICA/B, CD46, CD140b, CD146, CD147, CD81, CD151, CD200, and CD10; (b) detecting any recognition of the marker(s) by the detection agent(s); and (c) determining the cell has a non-fibroblastic phenotype when a detected cell-surface marker of corneal endothelial cells with a non-fibroblastic phenotype is expressed at a higher level as compared to its expression level by a corneal endothelial cell with a fibroblastic phenotype, or
determining the cell has a fibroblastic phenotype when a detected cell-surface marker of corneal endothelial cells with a fibroblastic phenotype is expressed at a higher level as compared to its expression level by a corneal endothelial cell with a non-fibroblastic phenotype.
Instant claim 38 is drawn to a method of preparing a corneal endothelial cell sample with an elevated ratio of corneal endothelial cells with a non-fibroblastic phenotype to corneal endothelial cells with a fibroblastic phenotype, comprising:
in a corneal endothelial cell sample comprising cells with a non-fibroblastic phenotype and corneal endothelial cells with a fibroblastic phenotype, elevating the relative amount of corneal endothelial cells with a non-fibroblastic phenotype expressing one or more cell-surface markers of corneal endothelial cells with a non-fibroblastic phenotype selected from the group consisting of CD166, HLA-A2, CD66a, CD66c, CD66d, CD66e, CD98, CD59, CD54, CD340, CD47, EGF-R, CD29, CD74, CD165, CD221, CD49a, SSEA-4, CD130, and CD49f, at a higher level as compared to its expression level by a corneal endothelial cell with a fibroblastic phenotype, thereby obtaining a corneal endothelial cell sample with an elevated ratio of corneal endothelial cells with a non-fibroblastic phenotype to corneal endothelial cells with a fibroblastic phenotype.
Claim 1 of U.S. Patent ‘334 is drawn to a method for determining the fibroblastic status of a corneal endothelial cell, comprising: (a) contacting a sample comprising the corneal endothelial cell with one or more detection agents selected from: (i) one or more non-fibroblastic detection agents for endothelial cells with a non-fibroblastic phenotype, wherein each non-fibroblastic detection agent binds a cell-surface marker present on corneal endothelial cells with a non-fibroblastic phenotype selected from the group consisting of CD166, HLA-A2, CD66a, CD66c, CD66d, CD66e, CD98, CD59, CD54, CD340, CD47, EGF-R, CD29, CD74, CD165, CD221, CD49a, SSEA-4, CD130, and CD49f, and (ii) one or more fibroblastic detection agents for endothelial cells with a fibroblastic phenotype, wherein each fibroblastic detection agent binds a cell-surface marker present on corneal endothelial cells with a fibroblastic phenotype selected from the group consisting of CD26, CD9, CD49b, CD49e, CD13, CD99, CD105, CD63, CD58, CD201, CD56, CD44, CD55, CD71, CD73, CD91, HLA-DQ, CD164, CD49d, CD49c, CD90, MICA/B, CD46, CD140b, CD146, CD147, CD81, CD151, CD200, and CD10;
(b) detecting any binding between the detection agent(s) and the marker(s) expressed on the cell; and (c) determining the cell has a non-fibroblastic phenotype when a cell-surface marker bound by one or more of the non-fibroblastic detection agents is expressed on the cell at a higher level as compared to its expression level on a corneal endothelial cell with a fibroblastic phenotype, or determining the cell has a fibroblastic phenotype when a cell-surface marker bound by one or more of the fibroblastic detection agents is expressed on the cell at a higher level as compared to its expression level on a corneal endothelial cell with a non-fibroblastic phenotype.
Claim 7 of U.S. Patent ‘334 is drawn to a method of preparing a corneal endothelial cell sample with an elevated ratio of corneal endothelial cells with a non-fibroblastic phenotype to corneal endothelial cells with a fibroblastic phenotype, comprising: depleting a sample comprising corneal endothelial cells with a non-fibroblastic phenotype and corneal endothelial cells with a fibroblastic phenotype of corneal endothelial cells expressing a cell-surface marker selected from the group consisting of CD26, CD9, CD49b, CD49e, CD13, CD99, CD105, CD63, CD58, CD201, CD56, CD44, CD55, CD71, CD73, CD91, HLA-DQ, CD164, CD49d, CD49c, CD90, MICA/B, CD46, CD140b, CD146, CD147, CD81, CD151, CD200, and CD10 at a higher level as compared to its expression level on a corneal endothelial cell with a non-fibroblastic phenotype, thereby elevating the ratio in the sample of corneal endothelial cells with a non-fibroblastic phenotype to corneal endothelial cells with a fibroblastic phenotype.
It is clear that all of the elements of application claims are to be found in patent claims (as the application claim fully encompasses patent claims). The difference between the application claims and the patent claims lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claims of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims is anticipated by claims of the patent, it is not patentably distinct from claims of the patent.
Claims 32-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10908161. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Instant claim 32 is drawn to a method for differentiating between corneal endothelial cells with a non-fibroblastic phenotype and corneal endothelial cells with a fibroblastic phenotype in a sample comprising corneal endothelial cells with a non-fibroblastic phenotype and corneal endothelial cells with a fibroblastic phenotype, comprising at least one of:
detecting corneal endothelial cells with a non-fibroblastic phenotype in the sample by detecting at least one cell-surface marker of corneal endothelial cells with a non-fibroblastic phenotype selected from the group consisting of CD166, HLA-A2, CD66a, CD66c, CD66d, CD66e, CD98, CD59, CD54, CD340, CD47, EGF-R, CD29, CD74, CD165, CD221, CD49a, SSEA-4, CD130, and CD49f, wherein the detected cell-surface marker of corneal endothelial cells with a non-fibroblastic phenotype is expressed at a higher level as compared to the expression level of the same cell-surface marker by a corneal endothelial cell with a fibroblastic phenotype, and
detecting corneal endothelial cells with a fibroblastic phenotype in the sample by detecting at least one cell-surface marker of corneal endothelial cells with a fibroblastic phenotype selected from the group consisting of CD26, CD9, CD49b, CD49e, CD13, CD99, CD105, CD63, CD58, CD201, CD56, CD44, CD55, CD71, CD73, CD91, HLA-DQ, CD164, CD49d, CD49c, CD90, MICA/B, CD46, CD140b, CD146, CD147, CD81, CD151, CD200, and CD10, wherein the detected cell-surface marker of corneal endothelial cells with a fibroblastic phenotype is expressed at a higher level as compared to the expression level of the same cell-surface marker by a corneal endothelial cell with a non-fibroblastic phenotype.
Claim 1 of U.S. Patent ‘161 is drawn to a method for differentiating between corneal endothelial cells with a non-fibroblastic phenotype and corneal endothelial cells with a fibroblastic phenotype in a sample comprising corneal endothelial cells with a non-fibroblastic phenotype and corneal endothelial cells with a fibroblastic phenotype, comprising at least one of:
detecting corneal endothelial cells with a non-fibroblastic phenotype in the sample by detecting at least one cell-surface marker present on corneal endothelial cells with a non-fibroblastic phenotype selected from the group consisting of CD166, HLA-A2, CD66a, CD66c, CD66d, CD66e, CD98, CD59, CD54, CD340, CD47, EGF-R, CD29, CD74, CD165, CD221, CD49a, SSEA-4, CD130, and CD49f, wherein the detecting comprises contacting the sample with a detection agent that binds the marker and detecting any binding between the detection agent and the marker, and wherein the cell-surface marker present on the corneal endothelial cell with a non-fibroblastic phenotype is expressed at a higher level compared to the expression level of the same cell-surface marker on a corneal endothelial cell with a fibroblastic phenotype, and
detecting corneal endothelial cells with a fibroblastic phenotype in the sample by detecting at least one cell-surface marker present on corneal endothelial cells with a fibroblastic phenotype selected from the group consisting of CD26, CD9, CD49b, CD49e, CD13, CD99, CD105, CD63, CD58, CD201, CD56, CD44, CD55, CD71, CD73, CD91, HLA-DQ, CD164, CD49d, CD49c, CD90, MICA/B, CD46, CD140b, CD146, CD147, CD81, CD151, CD200, and CD10, wherein the detecting comprises contacting the sample with a detection agent that binds the marker and detecting any binding between the detection agent and the marker, and wherein the cell-surface marker present on the corneal endothelial cell with a fibroblastic phenotype is expressed at a higher level compared to the expression level of the same cell-surface marker on a corneal endothelial cell with a non-fibroblastic phenotype.
It is clear that all of the elements of application claims are to be found in patent claims (as the application claim fully encompasses patent claims). The difference between the application claims and the patent claims lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claims of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims is anticipated by claims of the patent, it is not patentably distinct from claims of the patent.
Authorization to Initiate Electronic Communications
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Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632
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