DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 2-21 are pending, as per the preliminary amendment of 9/18/23, and are considered herein.
Formailities:
The drawings of 5/8/23 are accepted.
The specification of 9/18/23 is accepted.
The IDS filing of 6/13/23 has been considered and is signed off upon herein.
Claim Objections
Applicant is advised that should claim 2 be found allowable, claim 11 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 11 requires the originating epithelial cell population to have been isolated from a subject. However, all epithelial cells are isolated from a subject, whether they are directly isolated, or differentiated in culture from another cell into an epithelial cell. Thus, despite a slight difference in wording, these claims have substantially the same scope.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of U.S. Patent No. 9,790,471. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 2: Patent Claim 1 teaches proliferating epithelial cells ex vivo, by expanding the endothelial cells under conditions that include ALK5 inhibitor (a TGF beta inhibitor), a Rho-associated protein kinase inhibitor, a PAK inhibitor, and/or a myosin II inhibitor, the conditions also being serum-free and feeder free. Patent Claim 21 is similar. Claim 30 is to the population of epithelial cells so-expanded. Claim 36 is to a method of modifying epithelial cells, preformed under the same expansion.
Claim 3: Patent Claims 1, 26, 30, and 37 teach an ALK5 inhibitor.
Claim 4: Patent Claims 2, 26, 31, and 37 teach the same Markush of ALK 5 inhibitors. It should be noted that these compounds also inhibit ALK4 and ALK7.
Claim 5: Patent Claims 4, 27, 32, and 38 teach the same Markush of Rho-associated protein kinase inhibitors.
Claim 6: Patent Claims 6, 28, 33, and 39 teach IPA3.
Claim 7: Patent Claims 8, 29, 34, and 40 teach blebbistatin.
Claim 8: Patent Claims 9 and 25 teach a beta-adrenergic receptor agonist.
Claim 9: Patent Claim 13 and 25 teach at least one mitogenic growth factor.
Claim 10: Claims 12, 25, 35 and 41 teach calcium below 100 micromolar.
Claims 11-12: Claims 1, 25, 30, and 36 each teach that the epithelial cells may be derived from differentiated tissue, and thus, it is instantly envisioned to biopsy the same from an organism containing the differentiated tissue.
Claim 13: the cells are made by the Patent’s method claims (Claims 1-29 and 36-41), and are also present in the claims to the cells (Claims 30-35).
Claim 14: As seen above, Claims 1, 2, 3, 5, and 12-13 teaches the various elements. Also, Claim 25, 26, and 27 teach all the elements. Also, Claims 30-35 teach the elements in describing how the cells are made. And Claims 36-41 teach the same elements in modifying epithelial cell populations.
Claim 15: Claims 1, 25, 30, and 36 each teach that the epithelial cells may be derived from differentiated tissue, and thus, it is instantly envisioned to biopsy the same from an organism containing the differentiated tissue. And as seen above, the various elements are taught.
Claim 16: Patent Claims 1, 26, 30, and 37 teach an ALK5 inhibitor.
Claim 17: Patent Claims 2, 26, 31, and 37 teach the same Markush of ALK 5 inhibitors.
Claim 18: Patent Claims 4, 27, 32, and 38 teach the same Markush of Rho-associated protein kinase inhibitors.
Claim 20: Patent Claims 8, 29, 34, and 40 teach blebbistatin.
Claim 21: Patent Claims 9, 10, and 25 teach beta-adrenergic receptor agonists. Patent Claim 13 and 25 teach at least one mitogenic growth factor. Patent Claims 12, 25, 35 and 41 teach calcium below 100 micromolar.
Thus, the invention is obvious over the patent. The Artisan would make the invention in the process of practicing the patent’s claimed invention and/or as the result of the methods claimed.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of U.S. Patent No. 9,790,471 in view of Hussain, et al. (2014) “Isolation and culture of primary human nasal epithelial cells from anesthetized nasal epithelia”, Acta Oto-Laryngologica, 134: 296-99.
As shown above, the base claims are rejected over the patent alone, however, the word biopsy, while it is argued it is inherent, is not specifically mentioned in the claims.
On the other hand, Hussain teaches the biopsy and culture of nasal epithelial cells (e.g., CONCLUSION).
Thus, in light of the patent and Hussain, it would be obvious to make the invention, using a biopsy of these cells. The Artisan would do so and expect success, as it is claimed subject matter, and Hussain teaches such culturing can be performed with these epithelial cells.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-39 of U.S. Patent No. 9,963,680. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 2: Claim 1 is to proliferating epithelial cells, comprising expanding them under feeder-free and serum-free conditions, the culture conditions comprising a TGF-beta inhibitor. Claims 8-9 teach Rho-associated protein kinase inhibitor, a PAK inhibitor, and a myosin II inhibitor. Claim 29 teaches genetic modification of cells requiring expanding epithelial cells expanded under serum-free and feeder-free conditions, along with an inhibitor of TGF beta. Claim 35 teaches a Rho associated kinase inhibitor, a PAK inhibitor and a myosin II inhibitor.
Claim 3: Claims 5-6 and 32-33 teach ALK5 inhibitors.
Claim 4: Claims 6 and 33 teach the same Markush as ALK5 inhibitors. It should be noted that these compounds also inhibit ALK4 and ALK7.
Claim 5: Claims 9 and 36 teach the same Markush of Rho-associated kinase inhibitors.
Claim 6: Claims 10 and 37 teach IPA3.
Claim 7: Claims 11 and 28 teach blebbistatin.
Claim 8: Claims 12-13 teach beta-adrenergic receptor agonists.
Claim 9: Claims 16-17 teach mitogenic growth factors.
Claims 10-11: Claim 25 teaches to derive the epithelial cells from differentiated tissue, and thus, it is necessarily isolated by biopsy from the tissue.
Claim 13: The cells are necessarily made from the processes.
Claim 14: As addressed above, the methods claimed teach all the elements claimed, and it is noted that Claims 15 and 39 teach calcium below 100 micromolar.
Claim 15: The composition is made in the claimed processes, as shown above.
Claim 16: Claims 5-6 and 32-33 teach ALK5 inhibitors.
Claim 17: Claims 6 and 33 teach the same Markush as ALK5 inhibitors.
Claim 18: Claims 9 and 36 teach the same Markush of Rho-associated kinase inhibitors.
Claim 19: Claims 10 and 37 teach IPA3.
Claim 20: Claims 11 and 28 teach blebbistatin.
Claim 21: Claims 16-17 teach mitogenic growth factors, and Claims 15 and 39 teach calcium below 100 micromolar.
Thus, in light of the patent, the invention is obvious. The Artisan would make the invention in the process of practicing the patent, and as a result of the patent’s methods. The Artisan would expect success, as it is claimed subject matter.
Claims 2-11 and 13-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of U.S. Patent No. 10,119,121. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 2: Patent Claim 1 is to a method of proliferating epithelial cells ex vivo, comprising expanding them in a culture comprising a TGF-beta inhibitor, and a cytoskeletal structure disruption agent, the media being serum-free and feeder-cell free. Claim 2 indicates the TGF-beta inhibitor may be an ALK5 inhibitor Claim 4 indicates the cytoskeletal disrupting agent may be a myosin II inhibitor. Claim 5 indicates the cytoskeletal disrupting agent may be a Rho-associated kinase inhibitor. Claim 7 indicates the cytoskeletal disrupting agent may be a PAK inhibitor. Claim 35 is to proliferating cells ex vivo, comprising expanding epithelial cells with a serum and feeder-cell free media, comprising a TGF-beta signaling inhibitor, a rho-associated kinase inhibitor, a PAK inhibitor, or a myosin II inhibitor. Claim 37 is to the population made in similar serum and feeder conditions, with a TGF-beta inhibitor and an agent that disrupts cytoskeletal structure. Claim 39 teaches the RHO-associated kinase inhibitor, PAK inhibitor, and myosin II inhibitor. Claim 41 is to genetically modifying cells, including expanding cells under similar conditions, Claim 43 teaches the cytotskeletal disruption agents may be a Rho-associated kinase inhibitor, a PAK inhibitor, and a mysosin II inhibitor.
Claim 3: Claims 2, 3, 26, 28, 30, 38, and 42 teach ALK5 inhibitors.
Claim 4: Claims 3, 27, 29, and 31 teach the various ALK5 inhibitors. It should be noted that these compounds also inhibit ALK4 and ALK7.
Claim 5: Claim 6 teaches the same Markush of Rho-associated protein kinase inhibitors.
Claim 6: Claims 8 and 29 teach IPA3.
Claim 7: Claims 10 and 31 teach blebbistatin.
Claim 8: Claims 11-12, and 36 teach a beta-adrenergic receptor agonists.
Claim 9: Claims 15-16 and 36 teach a mitogenic growth factor.
Claim 10: Claims 14, 36, 40, and 44 teach calcium below 100 micromolar.
Claim 11: Claim 21 requires the population be derived of a tissue, and thus, it must be so isolated.
Claim 13: the methods are performed, and thus, the population is obtained at the conclusion. Claim 37, and depending claims, are directly claiming the cells so-produced.
Claim 14: as shown above, the various elements are present in the methods and required of the claims to the cells.
Claim 15: the media is made during the processes and required to make the epithelial cells claimed.
Claim 16: as shown above, Claims 3, 27, 29, and 31 teach the various ALK5 inhibitors. It should be noted that these compounds also inhibit ALK4 and ALK7.
Claim 17: Claims 3, 27, 29, and 31 teach elements of the Markush.
Claim 18: Claim 6 teaches the same Markush of Rho-associated protein kinase inhibitors.
Claim 19: Claims 8 and 29 teach IPA3.
Claim 20: Claims 10 and 31 teach blebbistatin.
Claim 21: Claims 11-12, and 36 teach a beta-adrenergic receptor agonists. Claims 15-16 and 36 teach a mitogenic growth factor. Claims 14, 36, 40, and 44 teach calcium below 100 micromolar.
Thus, in light of the patent, the invention is obvious. The Artisan would do so and expect success, as it is claimed subject matter, and would derive it in the process of performing the claims, or making the claimed cells.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of U.S. Patent No. 10,119,121 in view of Hussain, et al. (2014) “Isolation and culture of primary human nasal epithelial cells from anesthetized nasal epithelia”, Acta Oto-Laryngologica, 134: 296-99.
As shown above, the base claims are rejected over the patent alone, however, the patent claims do not claim the aspect of biopsy, and the Examiner does not believe it can be argued as essential written description, as it could be obtained in a tissue culture.
On the other hand, Hussain teaches the biopsy and culture of nasal epithelial cells (e.g., CONCLUSION).
Thus, in light of the patent and Hussain, it would be obvious to make the invention, using a biopsy of these cells. The Artisan would do so and expect success, as it is claimed subject matter, and Hussain teaches such culturing can be performed with these epithelial cells.
Claims 2-11 and 13-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,711,251. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 2: Patent Claim 1 teaches a cell culture, comprising epithelial cells, a serum-free and feeder free base media, a TGF-beta inhibitor, and one or more agents that modulate cytoskeletal structure. Claim 4 teaches the element Markush of Rho-associated kinase inhibitor, PAK inhibitor, and a myosin II inhibitor. Claim 10 teaches the culture composition for epithelial cell culture, comprising a serum and feeder free base medium, a TGF-beta inhibitor, a cytoskeletal modulating agent, a beta-adrenergic receptor agonist, a mitogenic growth factor, and calcium below 100 micromolar. Claim 11 makes clear the modulators of cytoskeletal structure may be a Rho-associated kinase inhibitor, a PAK inhibitor, and/or a myosin II inhibitor. Claim 22 teaches a composition of epithelial cells, a TGF-beta inhibitor, and modulator of cytoskeletal structure. Claims 23-24 teach the various elements of the Rho-associated kinase, the PAK inhibitor and myosin II inhibitor.
Claim 3: Claim 2-3, 11-12, 14-15, and 23-24 teach the ALK4, ALK5, and ALK7 inhibitors.
Claim 4: Claims 3, 12, 15, and 24 teach the Markush of ALK4, ALK5 and/or ALK7 inhibitors. It is noted that the Markush of inhibitors work on ALK4, ALK5 and ALK7.
Claim 5: Claim 5, 12, 17, and 24 teach the same Markush of Rho-associated kinase inhibitors.
Claim 6: Claims 5, 12, 17, and 24 teach IPA3.
Claim 7: Claims 5, 12, 17, and 24 teach blebbistatin.
Claim 8: Claims 6-7, 10, 18, and 19 teach beta-adrenergic receptor agonsits.
Claim 9: Claims 9-10 and 21 teach mitogenic growth factors.
Claim 10: Claims 8, 10, and 20 teach calcium below 100 micromolar.
Claim 11: all cells are obtained, either directly or indirectly, from a subject’s tissue.
Claim 13: As shown above, the compositions are made, and the process occurs over time, and is taught for the purpose of expanding a population of epithelial cells. Thus, the methods are performed as the purpose and the cells are obtained by the methods.
Claim 14: As shown above, the various elements are shown in the claimed subject matter, and for the purpose of proliferating epithelial cells.
Claim 15: As shown above, the compositions are made, and the process occurs over time, and is taught for the purpose of expanding a population of epithelial cells. Thus, the methods are performed as the purpose and the cells are obtained by the methods.
Claim 16: Claim 2-3, 11-12, 14-15, and 23-24 teach the ALK4, ALK5, and ALK7 inhibitors.
Claim 17: Claims 3, 12, 15, and 24 teach the Markush of ALK4, ALK5 and/or ALK7 inhibitors. It is noted that the Markush of inhibitors work on ALK4, ALK5 and ALK7.
Claim 18: Claim 5, 12, 17, and 24 teach the same Markush of Rho-associated kinase inhibitors.
Claim 19: Claims 5, 12, 17, and 24 teach IPA3.
Claim 20: Claims 5, 12, 17, and 24 teach blebbistatin.
Claim 21: Claims 6-7, 10, 18, and 19 teach beta-adrenergic receptor agonsits. Claims 9-10 and 21 teach mitogenic growth factors. Claims 8, 10, and 20 teach calcium below 100 micromolar.
Thus, in light of the patent, the invention is obvious. The Artisan would perform the method, as a result of the intended purpose of the claimed invention of the patent, and obtain the cells in the process. The Artisan would expect success, as it is claimed subject matter.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,711,251 in view of Hussain, et al. (2014) “Isolation and culture of primary human nasal epithelial cells from anesthetized nasal epithelia”, Acta Oto-Laryngologica, 134: 296-99.
As shown above, the base claims are rejected over the patent alone, however, the patent claims do not claim the aspect of biopsy, and the Examiner does not believe it can be argued as essential written description, as it could be obtained in a tissue culture.
On the other hand, Hussain teaches the biopsy and culture of nasal epithelial cells (e.g., CONCLUSION).
Thus, in light of the patent and Hussain, it would be obvious to make the invention, using a biopsy of these cells. The Artisan would do so and expect success, as it is claimed subject matter, and Hussain teaches such culturing can be performed with these epithelial cells.
Claims 2-11 and 13-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,711,250. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 2: Claim 1 teaches proliferating epithelial cells in a serum and feeder free culture, comprising a TGF-beta inhibitor. Claim 5 teaches a further rho-associated kinase inhibitor, PAK inhibitor, and/or myosin II inhibitor. Claim 18 teaches proliferating an epithelial population under serum- and feeder- free conditions, further comprising a TGF-beta inhibitor, a cytoskeletal structure modulator, a beta-adrenergic receptor agonist, a mitogenic growth factor, and calcium below 100 micromolar. Claim 19 teaches the cytoskeletal structure inhibitor may be a myosin II inhibitor.
Claim 3: Claims 2-3, 17, 19-20 teach ALK4, ALK5, and/or ALK7.
Claim 4: Claims 3 and 20 teach the same Markush of ALK4/5/7 inhibitors (it is noted that all of these inhibit all of ALK4, ALK5 and ALK7).
Claim 5: Claims 6 and 20 teach the same Markush of Rho-associated kinase inhibitors.
Claim 6: Claims 7 and 20 teach IPA3.
Claim 7: Claims 8 and 20 teach blebbistatin.
Claim 8: Claims 9-10 and 18 teach beta-adrenergic receptor agonists.
Claim 9: Claims 12-13 and 18 teach mitogenic growth factors.
Claim 10: Claims 11 and 18 teach calcium below 100 micromolar.
Claim 11: all cells are obtained, either directly or indirectly, from a subject’s tissue.
Claim 13: the methods necessarily produce the cells.
Claim 14: as shown above, the various aspects are taught in the claims.
Claim 15: as shown above, the methods require making the composition.
Claim 16: Claims 2-3, 17, 19-20 teach ALK4, ALK5, and/or ALK7.
Claim 17: Claims 3 and 20 teach the same Markush of ALK4/5/7 inhibitors (it is noted that all of these inhibit all of ALK4, ALK5 and ALK7).
Claim 18: Claims 6 and 20 teach the same Markush of Rho-associated kinase inhibitors.
Claim 19: Claims 7 and 20 teach IPA3.
Claim 20: Claims 8 and 20 teach blebbistatin.
Claim 21: Claims 9-10 and 18 teach beta-adrenergic receptor agonists.
*it is noted that patent is limited to in-vitro differentiated from iPSC cells, and so direct isolation from tissue is not rejected (Claims 11-12).
Thus, in light of the patent, the invention is obvious. The Artisan would make the claimed invention because the patent claims teach it, and as a result of it, the cells are also obtained. The Artisan would expect success, as it is claimed subject matter.
Claims 1-11 and 13-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,680,246. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 2: Patent Claim 1 teaches proliferating epithelial cells ex vivo, under serum- and feeder- free conditions, in the presence of a TGF-beta signalling inhibitor. Claim 5 teaches it may further comprise a rho-associated kinase inhibitor, a PAK inhibitor, and/or a myosin II inhibitor. Claim 15 teaches a similar method to Claim 1, the composition further comprising a few more elements. Claim 16 teaches it may further comprise a rho-associated kinase inhibitor, a PAK inhibitor, and/or a myosin II inhibitor. Claim 18 teaches the composition itself, similar to Claim 1 but also a modulator of cytoskeletal structure, Claim 19 teaching the various elements of rho-associated kinase inhibitor, PAK inhibitor, and myosin II inhibitor.
Claim 3: Claims 2-3, 14, 16-17, and 19-20 teach ALK5, ALK4, and ALK7 inhibitors.
Claim 4: Claims 3, 17, and 20 teach the same Markush of inhibitors, which inhibit each of ALK5, ALK4, and ALK7.
Claim 5: Claims 6, 17, and 20 teach the same Markush of Rho-associated kinase inhibitors.
Claim 6: Claims 7, 17, and 20 teach IPA3.
Claim 7: Claims 8, 17, and 20 teach blebbistatin.
Claim 8: Claims 9-10 and 15 teach a beta-adrenergic receptor agonist.
Claim 9: Claims 12-13 and 15 teach mitogenic growth factors.
Claim 10: Claims 11 and 15 teach calcium below 100 micromolar.
Claim 11: all cells are obtained, either directly or indirectly, from a subject’s tissue.
Claim 13: the methods are taught and the composition is taught, as shown above.
Claim 14: as shown above, the methods are taught, and the cells so-obtained. Also, Claims 9-10 and 15 teach a beta-adrenergic receptor agonist, Claims 12-13 and 15 teach mitogenic growth factors ,and Claims 11 and 15 teach calcium below 100 micromolar.
Claim 15: as shown above, the various elements are taught.
Claim 16: Claims 2-3, 14, 16-17, and 19-20 teach ALK5, ALK4, and ALK7 inhibitors.
Claim 17: Claims 3, 17, and 20 teach the same Markush of inhibitors, which inhibit each of ALK5, ALK4, and ALK7.
Claim 18: Claims 6, 17, and 20 teach the same Markush of Rho-associated kinase inhibitors.
Claim 19: Claims 7, 17, and 20 teach IPA3.
Claim 20: Claims 8, 17, and 20 teach blebbistatin.
Claim 21: Claims 9-10 and 15 teach a beta-adrenergic receptor agonist.
Thus, in light of the patent, the invention is obvious. The Artisan would do so and expect success as it is claimed, and the cells are produced by the claimed methods.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,680,246 in view of Hussain, et al. (2014) “Isolation and culture of primary human nasal epithelial cells from anesthetized nasal epithelia”, Acta Oto-Laryngologica, 134: 296-99.
As shown above, the base claims are rejected over the patent alone, however, the patent claims do not claim the aspect of biopsy, and the Examiner does not believe it can be argued as essential written description, as it could be obtained in a tissue culture.
On the other hand, Hussain teaches the biopsy and culture of nasal epithelial cells (e.g., CONCLUSION).
Thus, in light of the patent and Hussain, it would be obvious to make the invention, using a biopsy of these cells. The Artisan would do so and expect success, as it is claimed subject matter, and Hussain teaches such culturing can be performed with these epithelial cells.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 10,066,201. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 2: Patent Claim 1 teaches proliferating epithelial cells under feeder-free and serum-free conditions, in the presence of a TGF-beta inhibitor. Claim 9 teaches the inclusion of Rho-associated kinase inhibitors, PAK inhibitors and/or myosin II inhibitors. Claim 22 is similar to Claim 1, but includes some other elements. Claim 23 teaches modifying cells, the cells being an epithelial population cultured under similar conditions. Claim 32 further limits Claim 23 to including Rho-associated kinase inhibitors, PAK inhibitors and/or myosin II inhibitors.
Claim 3: Claims 5-6 and 31 teach ALK5 inhibitors.
Claim 4: Claim 6 teaches the same Markush of ALK5 inhibitors, which also inhibit ALK4 and ALK7.
Claim 5: Claim 10 teaches the same Markush of Rho-associated kinase inhibitors.
Claim 6: Claim 11 teaches IPA3.
Claim 7: Claim 12 teaches blebbistatin.
Claim 8: Claims 14-15 teach beta-adrenergic receptor agonists.
Claim 9: Claim 21 teaches several mitogenic growth factors.
Claim 10: Claims 19 and 35 tach calcium below 100 micromolar.
Claim 11: Claims 1 and 22-24 teach obtained from a human and from differentiated tissue.
Claim 12: because it is obtained from a human, and from differentiated tissue, it must be biopsied from that tissue.
Claim 13: As shown above, the methods occur, and thus the cells result from the process.
Claim 14: As shown above, the various elements are taught, including Claims 14-15 teach a beta-adrenergic receptor agonist, Claim 20 teaches mitogenic growth factors ,and Claims 19 and 35 teach calcium below 100 micromolar.
Claim 15: as shown above, the methods require the production of the compositions.
Claim 16: Claims 5-6 and 31 teach ALK5 inhibitors.
Claim 17: Claim 6 teaches the same Markush of ALK5 inhibitors, which also inhibit ALK4 and ALK7.
Claim 18: Claim 10 teaches the same Markush of Rho-associated kinase inhibitors.
Claim 19: Claim 11 teaches IPA3.
Claim 20: Claim 12 teaches blebbistatin.
Claim 21: Claims 14-15 teach beta-adrenergic receptor agonists.
Thus, in light of the patent, the invention is obvious. The Artisan would do so and expect success, as it is produced during the methods claimed in the patent.
Claims 2-11 and 13-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 10,100,285. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 2: Patent Claim 1 teaches proliferating epithelial cells, by expanding the same in culture, the media being feeder- and serum- free, and comprising a TGF-beta inhibitor and a disruptor of cytoskeletal structure. Claim 7 teaches that the disruptor may be a Rho-associated protein kinase inhibitor, a PAK inhibitor, and/or a myosin II inhibitor. Claim 26 is similarly to proliferating epithelial cells ex vivo, in feeder- and serum- free conditions, in the presence of a TGF-beta inhibitor, a Rho-associated protein kinase inhibitor, a PAK inhibitor, and a myosin II inhibitor. Claim 27 is to epithelial cells so-expanded by the methods. Claim 28 is to genetic modification of epithelial cells, under the same expansion conditions.
Claim 3: Claims 5-6, 20, 22, 24, 29, and 32 teach ALK5 inhibitors, and Claim 6 provides several ALK5 inhibitors which are also ALK4 and ALK7 inhibitors.
Claim 4: Claim 6 provides the same ALK5 inhibitors which are also ALK4 and ALK7 inhibitors.
Claim 5: Claim 9 provides the same Markush of Rho-associated protein kinase inhibitors.
Claim 6: Claims 11 and 23 provide IPA3.
Claim 7: Claims 13 and 25 provide for blebbistatin.
Claim 8: Claims 14-15 and 26 provide for beta-adrenergic receptor agonists.
Claim 9: Claims 18-19 and 26 provide for mitogenic growth factors.
Claim 10: Claims 17, 26, 31, and 34 provide for calcium below 100 micromolar.
Claim 11: all cells are derived directly, or indirectly, from a subject’s tissue.
Claim 13: the methods provide for making the cells claimed, and Claims 27 and 29-31 are to the cells so-made.
Claim 14: As shown above the various aspects are taught and Claims 14-15 and 26 provide for beta-adrenergic receptor agonists, Claims 18-19 and 26 provide for mitogenic growth factors and Claims 17, 26, 31, and 34 provide for calcium below 100 micromolar.
Claim 15: As shown above, the compositions are made in the process of performing the methods, or making the cells claimed.
Claim 16: Claims 5-6, 20, 22, 24, 29, and 32 teach ALK5 inhibitors, and Claim 6 provides several ALK5 inhibitors which are also ALK4 and ALK7 inhibitors.
Claim 17: Claim 6 provides the same ALK5 inhibitors which are also ALK4 and ALK7 inhibitors.
Claim 18: Claim 9 provides the same Markush of Rho-associated protein kinase inhibitors.
Claim 19: Claims 11 and 23 provide IPA3.
Claim 20: Claims 13 and 25 provide for blebbistatin.
Claim 21: Claims 14-15 and 26 provide for beta-adrenergic receptor agonists.
Thus, in light of the patent, the invention is obvious. The Artisan would make the compositions in the processes claimed, and as a result of the methods made, as well as the cells so-claimed. The Artisan would expect success, as it is claimed.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10,100,285 in view of Hussain, et al. (2014) “Isolation and culture of primary human nasal epithelial cells from anesthetized nasal epithelia”, Acta Oto-Laryngologica, 134: 296-99.
As shown above, the base claims are rejected over the patent alone, however, the patent claims do not claim the aspect of biopsy, and the Examiner does not believe it can be argued as essential written description, as it could be obtained in a tissue culture.
On the other hand, Hussain teaches the biopsy and culture of nasal epithelial cells (e.g., CONCLUSION).
Thus, in light of the patent and Hussain, it would be obvious to make the invention, using a biopsy of these cells. The Artisan would do so and expect success, as it is claimed subject matter, and Hussain teaches such culturing can be performed with these epithelial cells.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/ Primary Examiner, Art Unit 1638