DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 10-28 are under consideration in this office action.
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.
(1) Claims 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10-15, and 20 of U.S. Patent No.12,227,768. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patent claims comprise overlapping, non-mutually exclusive subject matter and thus the instant claims are an obvious variant of the patent claim.
Regarding claim 10, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more narrowly recites “transfecting” the differentiated cells with mRNA encoding reprogramming factor, whereas instant claim 1 more broadly recited “contact the differentiated cell”…”resulting in the differentiated cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 10. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 10.
Regarding claim 11, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 11 obvious for reasons regarding transfection timing discussed above.
Regarding claim 12, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 12 obvious for reasons regarding transfection timing discussed above.
Regarding claims 13 and 19, patent claim 1 more broadly recites reprogramming factor, whereas claim 13 narrowly recites reprogramming factors comprising a DNA binding domain and claim 19 specifies species of reprogramming factors Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Utf1. However, at the time of patent claim 1, the Yamanaka factors recited in claim 19, Nanog, and Lin28 were art-established reprogramming transcription factors that functioned via a DNA binding domain. As such, it would have been obvious to an artisan of ordinary skill to use any of the claimed Yamanaka factor, Nanog, or Lin28 as the species of reprogramming factors in patent claim 1 to predictably arrive at the limitations of claims 13 and 19.
Regarding claim 14, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 15, patent claim 3 specifies the biopsy as a dermal punch biopsy.
Regarding claim 16, patent claim 5 specifies the cell as a skin cell.
Regarding claim 17, patent claim 4 specifies the cell as human.
Regarding claim 18, patent claim 10 specifies substantially free of immunosuppressants.
Regarding claim 20, patent claim 11 teaches a method of reprogramming a differentiated state. Patent claim 11 more narrowly recites “transfecting” the non-pluripotent cells with mRNA encoding reprogramming factor, whereas instant claim 20 more broadly recited “contact the differentiated cell”…”resulting in the non-pluripotent cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 20. Patent claim 11 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 20.
Regarding claim 21, again this claim specifies timing of transfection/contacting, as such patent claim 11 renders instant claim 21 obvious for reasons regarding transfection timing discussed above.
Regarding claim 22, again this claim specifies timing of transfection/contacting, as such patent claim 11 renders instant claim 22 obvious for reasons regarding transfection timing discussed above.
Regarding claims 23 and 29, patent claim 11 more broadly recites reprogramming factor, whereas claim 23 narrowly recites reprogramming factors comprising a DNA binding domain and claim 29 specifies species of reprogramming factors Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Utf1. However, at the time of patent claim 11, the Yamanaka factors recited in claim 29, Nanog, and Lin28 were art-established reprogramming transcription factors that functioned via a DNA binding domain. As such, it would have been obvious to an artisan of ordinary skill to use any of the claimed Yamanaka factor, Nanog, or Lin28 as the species of reprogramming factors in patent claim 11 to predictably arrive at the limitations of claims 23 and 29.
Regarding claim 24, patent claim 12 specifies the differentiated cell is from a biopsy.
Regarding claim 25, patent claim 13 specifies the biopsy as a dermal punch biopsy.
Regarding claim 26, patent claim 15 specifies the cell as a skin cell.
Regarding claim 27, patent claim 14 specifies the cell as human.
Regarding claim 28, patent claim 20 specifies substantially free of immunosuppressants.
(2) Claims 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-13, and 16 of U.S. Patent No.11,492,600. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patent claims comprise overlapping, non-mutually exclusive subject matter and thus the instant claims are an obvious variant of the patent claim.
Regarding claim 10, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more narrowly recites “transfecting” the differentiated cells with mRNA encoding reprogramming factor, whereas instant claim 1 more broadly recited “contact the differentiated cell”…”resulting in the differentiated cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 10. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine-optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 10.
Regarding claim 11, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 11 obvious for reasons regarding transfection timing discussed above.
Regarding claim 12, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 12 obvious for reasons regarding transfection timing discussed above.
Regarding claims 13 and 19, patent claim 1 recites wherein the reprogramming factors comprise are one or more of reprogramming factors transcription factor (i.e. comprises DNA binding domain) selected from the group consisting of Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, Tert.
Regarding claim 14, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 15, patent claim 3 specifies the biopsy as a dermal punch biopsy.
Regarding claim 16, patent claim 5 specifies the cell as a skin cell.
Regarding claim 17, patent claim 4 specifies the cell as human.
Regarding claim 18, patent claim 8 specifies substantially free of immunosuppressants.
Regarding claim 20, patent claim 9 teaches a method of reprogramming a differentiated state. Patent claim 11 more narrowly recites “transfecting” the non-pluripotent cells with mRNA encoding reprogramming factor, whereas instant claim 20 more broadly recited “contact the differentiated cell”…”resulting in the non-pluripotent cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 20. Patent claim 8 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 20.
Regarding claim 21, again this claim specifies timing of transfection/contacting, as such patent claim 9 renders instant claim 21 obvious for reasons regarding transfection timing discussed above.
Regarding claim 22, again this claim specifies timing of transfection/contacting, as such patent claim 9 renders instant claim 22 obvious for reasons regarding transfection timing discussed above.
Regarding claims 23 and 29, patent claim 9 recites wherein the reprogramming factors comprise are one or more of reprogramming factors transcription factor (i.e. comprises DNA binding domain) selected from the group consisting of Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, Tert.
Regarding claim 24, patent claim 10 specifies the differentiated cell is from a biopsy.
Regarding claim 25, patent claim 11 specifies the biopsy as a dermal punch biopsy.
Regarding claim 26, patent claim 13 specifies the cell as a skin cell.
Regarding claim 27, patent claim 12 specifies the cell as human.
Regarding claim 28, patent claim 16 specifies substantially free of immunosuppressants.
(3) Claims 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-13 and 16 of U.S. Patent No. 10,443,045. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patent claims comprise overlapping, non-mutually exclusive subject matter and thus the instant claims are an obvious variant of the patent claim.
Regarding claim 10, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more narrowly recites “transfecting” the differentiated cells with mRNA encoding reprogramming factor, whereas instant claim 1 more broadly recited “contact the differentiated cell”…”resulting in the differentiated cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 10. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 10.
Regarding claim 11, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 11 obvious for reasons regarding transfection timing discussed above.
Regarding claim 12, patent claim 1 recites repeating (b) at least twice.
Regarding claims 13 and 19, patent claim 1 more broadly recites reprogramming factor, whereas claim 13 narrowly recites reprogramming factors comprising a DNA binding domain and claim 19 specifies species of reprogramming factors Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Utf1. However, at the time of patent claim 1, the Yamanaka factors recited in claim 19, Nanog, and Lin28 were art-established reprogramming transcription factors that functioned via a DNA binding domain. As such, it would have been obvious to an artisan of ordinary skill to use any of the claimed Yamanaka factor, Nanog, or Lin28 as the species of reprogramming factors in patent claim 1 to predictably arrive at the limitations of claims 13 and 19.
Regarding claim 14, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 15, patent claim 3 specifies the biopsy as a dermal punch biopsy.
Regarding claim 16, patent claim 5 specifies the cell as a skin cell.
Regarding claim 17, patent claim 4 specifies the cell as human.
Regarding claim 18, patent claim 8 specifies substantially free of immunosuppressants.
Regarding claim 20, patent claim 9 teaches a method of reprogramming a differentiated state. Patent claim 11 more narrowly recites “transfecting” the non-pluripotent cells with mRNA encoding reprogramming factor, whereas instant claim 20 more broadly recited “contact the differentiated cell”…”resulting in the non-pluripotent cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 20. Patent claim 11 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 20.
Regarding claim 21, again this claim specifies timing of transfection/contacting, as such patent claim 8 renders instant claim 21 obvious for reasons regarding transfection timing discussed above.
Regarding claim 22, patent claim 9 recites repeating (b) at least twice.
Regarding claims 23 and 29, patent claim 9 more broadly recites reprogramming factor, whereas claim 23 narrowly recites reprogramming factors comprising a DNA binding domain and claim 29 specifies species of reprogramming factors Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Utf1. However, at the time of patent claim 11, the Yamanaka factors recited in claim 29, Nanog, and Lin28 were art-established reprogramming transcription factors that functioned via a DNA binding domain. As such, it would have been obvious to an artisan of ordinary skill to use any of the claimed Yamanaka factor, Nanog, or Lin28 as the species of reprogramming factors in patent claim 11 to predictably arrive at the limitations of claims 23 and 29.
Regarding claim 24, patent claim 10 specifies the differentiated cell is from a biopsy.
Regarding claim 25, patent claim 11 specifies the biopsy as a dermal punch biopsy.
Regarding claim 26, patent claim 13 specifies the cell as a skin cell.
Regarding claim 27, patent claim 12 specifies the cell as human.
Regarding claim 28, patent claim 16 specifies substantially free of immunosuppressants.
(4) Claims 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-13 and 16 of U.S. Patent No. 10,301,599. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patent claims comprise overlapping, non-mutually exclusive subject matter and thus the instant claims are an obvious variant of the patent claim.
Regarding claim 10, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more narrowly recites “transfecting” the differentiated cells with mRNA encoding reprogramming factor, whereas instant claim 1 more broadly recited “contact the differentiated cell”…”resulting in the differentiated cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 10. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 10.
Regarding claim 11, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 11 obvious for reasons regarding transfection timing discussed above.
Regarding claim 12, patent claim 1 recites repeating (b) at least twice.
Regarding claims 13 and 19, patent claim 1 more broadly recites reprogramming factor, whereas claim 13 narrowly recites reprogramming factors comprising a DNA binding domain and claim 19 specifies species of reprogramming factors Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Utf1. However, at the time of patent claim 1, the Yamanaka factors recited in claim 19, Nanog, and Lin28 were art-established reprogramming transcription factors that functioned via a DNA binding domain. As such, it would have been obvious to an artisan of ordinary skill to use any of the claimed Yamanaka factor, Nanog, or Lin28 as the species of reprogramming factors in patent claim 1 to predictably arrive at the limitations of claims 13 and 19.
Regarding claim 14, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 15, patent claim 3 specifies the biopsy as a dermal punch biopsy.
Regarding claim 16, patent claim 5 specifies the cell as a skin cell.
Regarding claim 17, patent claim 4 specifies the cell as human.
Regarding claim 18, patent claim 8 specifies substantially free of immunosuppressants.
Regarding claim 20, patent claim 9 teaches a method of reprogramming a differentiated state. Patent claim 11 more narrowly recites “transfecting” the non-pluripotent cells with mRNA encoding reprogramming factor, whereas instant claim 20 more broadly recited “contact the differentiated cell”…”resulting in the non-pluripotent cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 20. Patent claim 11 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 20.
Regarding claim 21, again this claim specifies timing of transfection/contacting, as such patent claim 8 renders instant claim 21 obvious for reasons regarding transfection timing discussed above.
Regarding claim 22, patent claim 9 recites repeating (b) at least twice.
Regarding claims 23 and 29, patent claim 9 more broadly recites reprogramming factor, whereas claim 23 narrowly recites reprogramming factors comprising a DNA binding domain and claim 29 specifies species of reprogramming factors Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Utf1. However, at the time of patent claim 11, the Yamanaka factors recited in claim 29, Nanog, and Lin28 were art-established reprogramming transcription factors that functioned via a DNA binding domain. As such, it would have been obvious to an artisan of ordinary skill to use any of the claimed Yamanaka factor, Nanog, or Lin28 as the species of reprogramming factors in patent claim 11 to predictably arrive at the limitations of claims 23 and 29.
Regarding claim 24, patent claim 10 specifies the differentiated cell is from a biopsy.
Regarding claim 25, patent claim 11 specifies the biopsy as a dermal punch biopsy.
Regarding claim 26, patent claim 13 specifies the cell as a skin cell.
Regarding claim 27, patent claim 12 specifies the cell as human.
Regarding claim 28, patent claim 16 specifies substantially free of immunosuppressants.
(5) Claims 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-13 and 16 of U.S. Patent No. 10,131,882. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patent claims comprise overlapping, non-mutually exclusive subject matter and thus the instant claims are an obvious variant of the patent claim.
Regarding claim 10, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more narrowly recites “transfecting” the differentiated cells with mRNA encoding reprogramming factor, whereas instant claim 1 more broadly recited “contact the differentiated cell”…”resulting in the differentiated cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 10. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 10.
Regarding claim 11, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 11 obvious for reasons regarding transfection timing discussed above.
Regarding claim 12, patent claim 1 recites repeating (b) at least twice.
Regarding claims 13 and 19, patent claim 1 more broadly recites reprogramming factor, whereas claim 13 narrowly recites reprogramming factors comprising a DNA binding domain and claim 19 specifies species of reprogramming factors Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Utf1. However, at the time of patent claim 1, the Yamanaka factors recited in claim 19, Nanog, and Lin28 were art-established reprogramming transcription factors that functioned via a DNA binding domain. As such, it would have been obvious to an artisan of ordinary skill to use any of the claimed Yamanaka factor, Nanog, or Lin28 as the species of reprogramming factors in patent claim 1 to predictably arrive at the limitations of claims 13 and 19.
Regarding claim 14, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 15, patent claim 4 specifies the biopsy as a dermal punch biopsy.
Regarding claim 16, patent claim 5 specifies the cell as a skin cell.
Regarding claim 17, patent claim 3 specifies the cell as human.
Regarding claim 18, patent claim 8 specifies substantially free of immunosuppressants.
Regarding claim 20, patent claim 9 teaches a method of reprogramming a differentiated state. Patent claim 11 more narrowly recites “transfecting” the non-pluripotent cells with mRNA encoding reprogramming factor, whereas instant claim 20 more broadly recited “contact the differentiated cell”…”resulting in the non-pluripotent cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 20. Patent claim 11 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 20.
Regarding claim 21, again this claim specifies timing of transfection/contacting, as such patent claim 8 renders instant claim 21 obvious for reasons regarding transfection timing discussed above.
Regarding claim 22, patent claim 9 recites repeating (b) at least twice.
Regarding claims 23 and 29, patent claim 9 more broadly recites reprogramming factor, whereas claim 23 narrowly recites reprogramming factors comprising a DNA binding domain and claim 29 specifies species of reprogramming factors Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Utf1. However, at the time of patent claim 11, the Yamanaka factors recited in claim 29, Nanog, and Lin28 were art-established reprogramming transcription factors that functioned via a DNA binding domain. As such, it would have been obvious to an artisan of ordinary skill to use any of the claimed Yamanaka factor, Nanog, or Lin28 as the species of reprogramming factors in patent claim 11 to predictably arrive at the limitations of claims 23 and 29.
Regarding claim 24, patent claim 10 specifies the differentiated cell is from a biopsy.
Regarding claim 25, patent claim 12 specifies the biopsy as a dermal punch biopsy.
Regarding claim 26, patent claim 13 specifies the cell as a skin cell.
Regarding claim 27, patent claim 11 specifies the cell as human.
Regarding claim 28, patent claim 16 specifies substantially free of immunosuppressants.
(6) Claims 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6 of U.S. Patent No.9,969,983. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patent claims comprise overlapping, non-mutually exclusive subject matter and thus the instant claims are an obvious variant of the patent claim.
Regarding claim 10, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more recites, “non-pluripotent cell” whereas instant claim 10 recites “differentiated cell”. However an artisan would understand a non-pluripotent cell is any cell differentiated from an undifferentiated cell, including non-pluripotent cells. Patent claim 1 more narrowly recites “transfecting” the differentiated cells with mRNA encoding reprogramming factor, whereas instant claim 1 more broadly recited “contact the differentiated cell”…”resulting in the differentiated cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 10. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 10.
Regarding claim 11, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 11 obvious for reasons regarding transfection timing discussed above.
Regarding claim 12, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 12 obvious for reasons regarding transfection timing discussed above.
Regarding claims 13 and 19, patent claim 1 specifies the reprogramming factor as Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Tert as recited in claim 19. These are all transcription factors which comprised DNA binding domains as recites in claim 13.
Regarding claim 14, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 15, patent claim 2 specifies the biopsy as a dermal punch biopsy.
Regarding claim 16, patent claim 3 specifies the cell as a skin cell.
Regarding claim 17, patent claim 1 does not specify the species of cell. However, human would be one of the most obvious cell species to use given its applicability to humans and given Lin28 and Nanog were specific reprogramming factors found in human cells.
Regarding claim 18, patent claim 6 specifies substantially free of immunosuppressants.
Regarding claim 20, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more narrowly recites “transfecting” the non-pluripotent cells with mRNA encoding reprogramming factor, whereas instant claim 20 more broadly recited “contact the differentiated cell”…”resulting in the non-pluripotent cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 20. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 20.
Regarding claim 21, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 21 obvious for reasons regarding transfection timing discussed above.
Regarding claim 22, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 22 obvious for reasons regarding transfection timing discussed above.
Regarding claims 23 and 29, patent claim 1 specifies the reprogramming factor as Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Tert as recited in claim 19. These are all transcription factors which comprised DNA binding domains as recites in claim 13.
Regarding claim 24, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 25, patent claim 2 specifies the biopsy as a dermal punch biopsy.
Regarding claim 26, patent claim 3 specifies the cell as a skin cell.
Regarding claim 27, patent claim 1 does not specify the species of cell. However, human would be one of the most obvious cell species to use given its applicability to humans and given Lin28 and Nanog were specific reprogramming factors found in human cells.
Regarding claim 28, patent claim 6 specifies substantially free of immunosuppressants.
(7) Claims 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8of U.S. Patent No.9,879,228. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patent claims comprise overlapping, non-mutually exclusive subject matter and thus the instant claims are an obvious variant of the patent claim.
Regarding claim 10, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more recites, “non-pluripotent cell” whereas instant claim 10 recites “differentiated cell”. However an artisan would understand a non-pluripotent cell is any cell differentiated from an undifferentiated cell, including non-pluripotent cells. Patent claim 1 more narrowly recites “transfecting” the differentiated cells with mRNA encoding reprogramming factor, whereas instant claim 1 more broadly recited “contact the differentiated cell”…”resulting in the differentiated cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 10. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 10.
Regarding claim 11, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 11 obvious for reasons regarding transfection timing discussed above.
Regarding claim 12, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 12 obvious for reasons regarding transfection timing discussed above.
Regarding claims 13 and 19, patent claim 1 specifies the reprogramming factor as Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Tert as recited in claim 19. These are all transcription factors which comprised DNA binding domains as recites in claim 13.
Regarding claim 14, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 15, patent claim 4 specifies the biopsy as a dermal punch biopsy.
Regarding claim 16, patent claim 5 specifies the cell as a skin cell.
Regarding claim 17, patent claim 3 specifies a human
Regarding claim 18, patent claim 8 specifies substantially free of immunosuppressants.
Regarding claim 20, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more narrowly recites “transfecting” the non-pluripotent cells with mRNA encoding reprogramming factor, whereas instant claim 20 more broadly recited “contact the differentiated cell”…”resulting in the non-pluripotent cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 20. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 20.
Regarding claim 21, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 21 obvious for reasons regarding transfection timing discussed above.
Regarding claim 22, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 22 obvious for reasons regarding transfection timing discussed above.
Regarding claims 23 and 29, patent claim 1 specifies the reprogramming factor as Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Tert as recited in claim 19. These are all transcription factors which comprised DNA binding domains as recites in claim 13.
Regarding claim 24, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 25, patent claim 4 specifies the biopsy as a dermal punch biopsy.
Regarding claim 26, patent claim 5 specifies the cell as a skin cell.
Regarding claim 27, patent claim 3 specifies a human cell.
Regarding claim 28, patent claim 8 specifies substantially free of immunosuppressants.
(8) Claims 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8 of U.S. Patent No.9,695,401. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patent claims comprise overlapping, non-mutually exclusive subject matter and thus the instant claims are an obvious variant of the patent claim.
Regarding claim 10, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more recites, “non-pluripotent cell” whereas instant claim 10 recites “differentiated cell”. However an artisan would understand a non-pluripotent cell is any cell differentiated from an undifferentiated cell, including non-pluripotent cells. Patent claim 1 more narrowly recites “transfecting” the differentiated cells with mRNA encoding reprogramming factor, whereas instant claim 1 more broadly recited “contact the differentiated cell”…”resulting in the differentiated cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 10. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 10.
Regarding claim 11, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 11 obvious for reasons regarding transfection timing discussed above.
Regarding claim 12, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 12 obvious for reasons regarding transfection timing discussed above.
Regarding claims 13 and 19, patent claim 1 specifies the reprogramming factor as Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Tert as recited in claim 19. These are all transcription factors which comprised DNA binding domains as recites in claim 13.
Regarding claim 14, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 15, patent claim 4 specifies the biopsy as a dermal punch biopsy.
Regarding claim 16, patent claim 5 specifies the cell as a skin cell.
Regarding claim 17, patent claim 3 specifies a human
Regarding claim 18, patent claim 8 specifies substantially free of immunosuppressants.
Regarding claim 20, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more narrowly recites “transfecting” the non-pluripotent cells with mRNA encoding reprogramming factor, whereas instant claim 20 more broadly recited “contact the differentiated cell”…”resulting in the non-pluripotent cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 20. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 20.
Regarding claim 21, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 21 obvious for reasons regarding transfection timing discussed above.
Regarding claim 22, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 22 obvious for reasons regarding transfection timing discussed above.
Regarding claims 23 and 29, patent claim 1 specifies the reprogramming factor as Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Tert as recited in claim 19. These are all transcription factors which comprised DNA binding domains as recites in claim 13.
Regarding claim 24, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 25, patent claim 4 specifies the biopsy as a dermal punch biopsy.
Regarding claim 26, patent claim 5 specifies the cell as a skin cell.
Regarding claim 27, patent claim 3 specifies a human cell.
Regarding claim 28, patent claim 8 specifies substantially free of immunosuppressants.
(9) Claims 10-17, 19-27 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No.9,562,218. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patent claims comprise overlapping, non-mutually exclusive subject matter and thus the instant claims are an obvious variant of the patent claim.
Regarding claim 10, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more recites, “non-pluripotent cell” whereas instant claim 10 recites “differentiated cell”. However an artisan would understand a non-pluripotent cell is any cell differentiated from an undifferentiated cell, including non-pluripotent cells. Patent claim 1 more narrowly recites “transfecting” the differentiated cells with mRNA encoding reprogramming factor, whereas instant claim 1 more broadly recited “contact the differentiated cell”…”resulting in the differentiated cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 10. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 10.
Regarding claim 11, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 11 obvious for reasons regarding transfection timing discussed above.
Regarding claim 12, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 12 obvious for reasons regarding transfection timing discussed above.
Regarding claims 13 and 19, patent claim 1 specifies the reprogramming factor as Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Tert as recited in claim 19. These are all transcription factors which comprised DNA binding domains as recites in claim 13.
Regarding claim 14, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 15, patent claim 4 specifies the biopsy as a dermal punch biopsy.
Regarding claim 16, patent claim 5 specifies the cell as a skin cell.
Regarding claim 17, patent claim 3 specifies a human
Regarding claim 20, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more narrowly recites “transfecting” the non-pluripotent cells with mRNA encoding reprogramming factor, whereas instant claim 20 more broadly recited “contact the differentiated cell”…”resulting in the non-pluripotent cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 20. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 20.
Regarding claim 21, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 21 obvious for reasons regarding transfection timing discussed above.
Regarding claim 22, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 22 obvious for reasons regarding transfection timing discussed above.
Regarding claims 23 and 29, patent claim 1 specifies the reprogramming factor as Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Tert as recited in claim 19. These are all transcription factors which comprised DNA binding domains as recites in claim 13.
Regarding claim 24, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 25, patent claim 4 specifies the biopsy as a dermal punch biopsy.
Regarding claim 26, patent claim 5 specifies the cell as a skin cell.
Regarding claim 27, patent claim 3 specifies a human cell.
(10) Claims 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, and 12 of U.S. Patent No.9,399,761. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patent claims comprise overlapping, non-mutually exclusive subject matter and thus the instant claims are an obvious variant of the patent claim.
Regarding claim 10, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more narrowly recites “transfecting” the differentiated cells with mRNA encoding reprogramming factor, whereas instant claim 1 more broadly recited “contact the differentiated cell”…”resulting in the differentiated cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 10. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 10.
Regarding claim 11, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 11 obvious for reasons regarding transfection timing discussed above.
Regarding claim 12, patent claim 1 specifies that the transfection step happens at least twice.
Regarding claims 13 and 19, patent claim 12 specifies the reprogramming factors as Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Tert.
Regarding claim 14, patent claim 4 specifies the differentiated cell is from a biopsy.
Regarding claim 15, patent claim 5 specifies the biopsy as a dermal punch biopsy.
Regarding claim 16, patent claim 5 specifies the cell as a skin cell.
Regarding claim 17, patent claim 1 does not specify that the differentiated cell is a human cell. However, at the time of the patent, human cells would be the most obvious species of cell because of the applicability to humans. Further Lin 28 and Nanog were human reprogramming factors in the prior art. As such human is an obvious variant cell type for patent claim 1.
Regarding claim 18, patent claim 2 specifies substantially free of immunosuppressants.
Regarding claim 20, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 recites “a differentiated cell” whereas instant claim 20 recites “a non-pluripotent cell”. However, an artisan would recognize that a differentiated cell includes all non-pluripotent cells. As such, a non-pluripotent cells is and obvious variant of differentiated cell. Patent claim 11 more narrowly recites “transfecting” the non-pluripotent cells with mRNA encoding reprogramming factor, whereas instant claim 20 more broadly recited “contact the differentiated cell”…”resulting in the non-pluripotent cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 20. Patent claim 11 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 20.
Regarding claim 21, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 21 obvious for reasons regarding transfection timing discussed above.
Regarding claim 22, patent claim 1 specifies that the transfection step happens at least twice.
Regarding claims 23 and 29, patent claim 12 specifies the reprogramming factors as Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Tert.
Regarding claim 24, patent claim 4 specifies the differentiated cell is from a biopsy.
Regarding claim 25, patent claim 5 specifies the biopsy as a dermal punch biopsy.
Regarding claim 26, patent claim 5 specifies the cell as a skin cell.
Regarding claim 27, patent claim 1 does not specify that the differentiated cell is a human cell. However, at the time of the patent, human cells would be the most obvious species of cell because of the applicability to humans. Further Lin 28 and Nanog were human reprogramming factors in the prior art. As such human is an obvious variant cell type for patent claim 1.
Regarding claim 28, patent claim 2 specifies substantially free of immunosuppressants.
(11) Claims 10-17, 19-27 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, and 8 of U.S. Patent No.8,497,124. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patent claims comprise overlapping, non-mutually exclusive subject matter and thus the instant claims are an obvious variant of the patent claim.
Regarding claim 10, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more narrowly recites “transfecting” the differentiated cells with mRNA encoding reprogramming factor, whereas instant claim 1 more broadly recited “contact the differentiated cell”…”resulting in the differentiated cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 10. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 10.
Regarding claim 11, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 11 obvious for reasons regarding transfection timing discussed above.
Regarding claim 12, patent claim 1 specifies that the transfection step happens at least twice.
Regarding claims 13 and 19, patent claims 4 and 5 both specifies the reprogramming factors as Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Tert.
Regarding claim 14-16, patent claim 8 teaches the differentiate cell is a skin cell, teaching the limitations claim 16. Patent claim 8 does not specify that the skin cell is from a biopsy sample (claim 14), more specifically a dermal biopsy (claim 15). However, at the time of the patent claim the most convention means of obtaining skin cells for in vitro methods was to take a skin or dermal biopsy. As such, it would have been obvious to obtain the skin cell of patent claim 8 by dermal biopsy. Thus patent claim 8 renders instant claims 14-15 obvious.
Regarding claim 17, patent claim 1 does not specify that the differentiated cell is a human cell. However, at the time of the patent, human cells would be the most obvious species of cell because of the applicability to humans. Further Lin 28 and Nanog were human reprogramming factors in the prior art. As such human is an obvious variant cell type for patent claim 1.
Regarding claim 20, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 recites “a differentiated cell” whereas instant claim 20 recites “a non-pluripotent cell”. However, an artisan would recognize that a differentiated cell includes all non-pluripotent cells. As such, a non-pluripotent cells is and obvious variant of differentiated cell. Patent claim 11 more narrowly recites “transfecting” the non-pluripotent cells with mRNA encoding reprogramming factor, whereas instant claim 20 more broadly recited “contact the differentiated cell”…”resulting in the non-pluripotent cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 20. Patent claim 11 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 20.
Regarding claim 21, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 21 obvious for reasons regarding transfection timing discussed above.
Regarding claim 22, patent claim 1 specifies that the transfection step happens at least twice.
Regarding claims 23 and 29, patent claims 4 and 5 both specifies the reprogramming factors as Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Tert.
Regarding claim 24-26, patent claim 8 teaches the differentiate cell is a skin cell, teaching the limitations claim 26. Patent claim 8 does not specify that the skin cell is from a biopsy sample (claim 24), more specifically a dermal biopsy (claim 25). However, at the time of the patent claim the most convention means of obtaining skin cells for in vitro methods was to take a skin or dermal biopsy. As such, it would have been obvious to obtain the skin cell of patent claim 8 by dermal biopsy. Thus patent claim 8 renders instant claims 24-25 obvious.
Regarding claim 27, patent claim 1 does not specify that the differentiated cell is a human cell. However, at the time of the patent, human cells would be the most obvious species of cell because of the applicability to humans. Further Lin 28 and Nanog were human reprogramming factors in the prior art. As such human is an obvious variant cell type for patent claim 1.
(1) Claims 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10-15, and 20 of U.S. Patent No.12,227,768. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patent claims comprise overlapping, non-mutually exclusive subject matter and thus the instant claims are an obvious variant of the patent claim.
Regarding claim 10, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more narrowly recites “transfecting” the differentiated cells with mRNA encoding reprogramming factor, whereas instant claim 1 more broadly recited “contact the differentiated cell”…”resulting in the differentiated cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 10. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 10.
Regarding claim 11, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 11 obvious for reasons regarding transfection timing discussed above.
Regarding claim 12, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 12 obvious for reasons regarding transfection timing discussed above.
Regarding claims 13 and 19, patent claim 1 more broadly recites reprogramming factor, whereas claim 13 narrowly recites reprogramming factors comprising a DNA binding domain and claim 19 specifies species of reprogramming factors Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Utf1. However, at the time of patent claim 1, the Yamanaka factors recited in claim 19, Nanog, and Lin28 were art-established reprogramming transcription factors that functioned via a DNA binding domain. As such, it would have been obvious to an artisan of ordinary skill to use any of the claimed Yamanaka factor, Nanog, or Lin28 as the species of reprogramming factors in patent claim 1 to predictably arrive at the limitations of claims 13 and 19.
Regarding claim 14, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 15, patent claim 3 specifies the biopsy as a dermal punch biopsy.
Regarding claim 16, patent claim 5 specifies the cell as a skin cell.
Regarding claim 17, patent claim 4 specifies the cell as human.
Regarding claim 18, patent claim 10 specifies substantially free of immunosuppressants.
Regarding claim 20, patent claim 11 teaches a method of reprogramming a differentiated state. Patent claim 11 more narrowly recites “transfecting” the non-pluripotent cells with mRNA encoding reprogramming factor, whereas instant claim 20 more broadly recited “contact the differentiated cell”…”resulting in the non-pluripotent cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 20. Patent claim 11 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 20.
Regarding claim 21, again this claim specifies timing of transfection/contacting, as such patent claim 11 renders instant claim 21 obvious for reasons regarding transfection timing discussed above.
Regarding claim 22, again this claim specifies timing of transfection/contacting, as such patent claim 11 renders instant claim 22 obvious for reasons regarding transfection timing discussed above.
Regarding claims 23 and 29, patent claim 11 more broadly recites reprogramming factor, whereas claim 23 narrowly recites reprogramming factors comprising a DNA binding domain and claim 29 specifies species of reprogramming factors Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, and Utf1. However, at the time of patent claim 11, the Yamanaka factors recited in claim 29, Nanog, and Lin28 were art-established reprogramming transcription factors that functioned via a DNA binding domain. As such, it would have been obvious to an artisan of ordinary skill to use any of the claimed Yamanaka factor, Nanog, or Lin28 as the species of reprogramming factors in patent claim 11 to predictably arrive at the limitations of claims 23 and 29.
Regarding claim 24, patent claim 12 specifies the differentiated cell is from a biopsy.
Regarding claim 25, patent claim 13 specifies the biopsy as a dermal punch biopsy.
Regarding claim 26, patent claim 15 specifies the cell as a skin cell.
Regarding claim 27, patent claim 14 specifies the cell as human.
Regarding claim 28, patent claim 20 specifies substantially free of immunosuppressants.
(12) Claims 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7 and 4 of U.S. Patent No.12,227,757. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patent claims comprise overlapping, non-mutually exclusive subject matter and thus the instant claims are an obvious variant of the patent claim.
Regarding claim 10, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more narrowly recites “transfecting” the differentiated cells with mRNA encoding reprogramming factor, whereas instant claim 1 more broadly recited “contact the differentiated cell”…”resulting in the differentiated cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 10. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine-optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 10.
Regarding claim 11, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 11 obvious for reasons regarding transfection timing discussed above.
Regarding claim 12, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 12 obvious for reasons regarding transfection timing discussed above.
Regarding claims 13 and 19, patent claim 7 recites wherein the reprogramming factors comprise are one or more of reprogramming factors transcription factor (i.e. comprises DNA binding domain) selected from the group consisting of Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, Tert.
Regarding claim 14, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 15, patent claim 2 specifies the biopsy as a dermal punch biopsy.
Regarding claim 16, patent claim 2 specifies the cell as a skin cell.
Regarding claim 17, patent claim 2 specifies the cell as human. However, a human cell is the
Regarding claim 18, patent claim 4 specifies substantially free of immunosuppressants.
Regarding claim 20, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 11 more narrowly recites “transfecting” the non-pluripotent cells with mRNA encoding reprogramming factor, whereas instant claim 20 more broadly recited “contact the differentiated cell”…”resulting in the non-pluripotent cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 20. Patent claim 8 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 20.
Regarding claim 21, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 21 obvious for reasons regarding transfection timing discussed above.
Regarding claim 22, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 22 obvious for reasons regarding transfection timing discussed above.
Regarding claims 23 and 29, patent claim 1 recites wherein the reprogramming factors comprise are one or more of reprogramming factors transcription factor (i.e. comprises DNA binding domain) selected from the group consisting of Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28, Tert.
Regarding claim 24, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 25, patent claim 2 specifies the biopsy as a dermal punch biopsy.
Regarding claim 26, patent claim 2 specifies the cell as a skin cell.
Regarding claim 27, patent claim 2 specifies the cell as human.
Regarding claim 28, patent claim 4 specifies substantially free of immunosuppressants.
(13) Claims 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 8-11, 13, and 16 of U.S. Patent No.11,466.293. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patent claims comprise overlapping, non-mutually exclusive subject matter and thus the instant claims are an obvious variant of the patent claim.
Regarding claim 10, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more narrowly recites “transfecting” the differentiated cells with mRNA encoding reprogramming factor, whereas instant claim 1 more broadly recited “contact the differentiated cell”…”resulting in the differentiated cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 10. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 10.
Regarding claim 11, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 11 obvious for reasons regarding transfection timing discussed above.
Regarding claim 12, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 12 obvious for reasons regarding transfection timing discussed above.
Regarding claims 23 and 29, patent claim 16 teaches reprogramming factors are Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28 and Tert.
Regarding claim 14, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 15, patent claim 2 specifies the biopsy as a dermal punch biopsy.
Regarding claim 16, patent claim 3 specifies the cell as a skin cell.
Regarding claim 17, patent claim 3 specifies the cell as human.
Regarding claim 18, patent claim 5 specifies substantially free of immunosuppressants.
Regarding claim 20, patent claim 9 teaches a method of reprogramming a differentiated state. Patent claim 9 more narrowly recites “transfecting” the non-pluripotent cells with mRNA encoding reprogramming factor, whereas instant claim 20 more broadly recited “contact the differentiated cell”…”resulting in the non-pluripotent cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 20. Patent claim 9 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 20.
Regarding claim 21, again this claim specifies timing of transfection/contacting, as such patent claim 9 renders instant claim 21 obvious for reasons regarding transfection timing discussed above.
Regarding claim 22, again this claim specifies timing of transfection/contacting, as such patent claim 9 renders instant claim 22 obvious for reasons regarding transfection timing discussed above.
Regarding claims 23 and 29, patent claim 16 teaches reprogramming factors are Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28 and Tert.
Regarding claim 24, patent claim 10 specifies the differentiated cell is from a biopsy.
Regarding claim 25, patent claim 10 specifies the biopsy as a dermal punch biopsy.
Regarding claim 26, patent claim 11 specifies the cell as a skin cell.
Regarding claim 27, patent claim 11 specifies the cell as human.
Regarding claim 28, patent claim 13 specifies substantially free of immunosuppressants.
(13) Claims 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 8-11, 13, and 16 of U.S. Patent No.10,472,611. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and patent claims comprise overlapping, non-mutually exclusive subject matter and thus the instant claims are an obvious variant of the patent claim.
Regarding claim 10, patent claim 1 teaches a method of reprogramming a differentiated state. Patent claim 1 more narrowly recites “transfecting” the differentiated cells with mRNA encoding reprogramming factor, whereas instant claim 1 more broadly recited “contact the differentiated cell”…”resulting in the differentiated cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 10. Patent claim 1 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 10.
Regarding claim 11, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 11 obvious for reasons regarding transfection timing discussed above.
Regarding claim 12, again this claim specifies timing of transfection/contacting, as such patent claim 1 renders instant claim 12 obvious for reasons regarding transfection timing discussed above.
Regarding claims 23 and 29, patent claim 16 teaches reprogramming factors are Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28 and Tert.
Regarding claim 14, patent claim 2 specifies the differentiated cell is from a biopsy.
Regarding claim 15, patent claim 2 specifies the biopsy as a dermal punch biopsy.
Regarding claim 16, patent claim 3 specifies the cell as a skin cell.
Regarding claim 17, patent claim 3 specifies the cell as human.
Regarding claim 18, patent claim 5 specifies substantially free of immunosuppressants.
Regarding claim 20, patent claim 9 teaches a method of reprogramming a differentiated state. Patent claim 9 more narrowly recites “transfecting” the non-pluripotent cells with mRNA encoding reprogramming factor, whereas instant claim 20 more broadly recited “contact the differentiated cell”…”resulting in the non-pluripotent cells internalizing” the mRNA encoding reprogramming. As such, patent claim is reciting anticipatory species of “contacting” and “internalizing” the mRNA as reciting in instant claim 20. Patent claim 9 does not recite contacting or transfecting for “2 hours to 24 hours”. However, determining the amount of time needed for effective transfection was routine optimization at the time of the patent. As such, with would have been obvious to an artisan of ordinary skill to optimize the timing of transfection in patent claim to predicably arrive at the transfection timing recited in instant claim 20.
Regarding claim 21, again this claim specifies timing of transfection/contacting, as such patent claim 9 renders instant claim 21 obvious for reasons regarding transfection timing discussed above.
Regarding claim 22, again this claim specifies timing of transfection/contacting, as such patent claim 9 renders instant claim 22 obvious for reasons regarding transfection timing discussed above.
Regarding claims 23 and 29, patent claim 16 teaches reprogramming factors are Oct4, Sox2, Klf4, c-Myc, Nanog, Lin28 and Tert.
Regarding claim 24, patent claim 10 specifies the differentiated cell is from a biopsy.
Regarding claim 25, patent claim 10 specifies the biopsy as a dermal punch biopsy.
Regarding claim 26, patent claim 11 specifies the cell as a skin cell.
Regarding claim 27, patent claim 11 specifies the cell as human.
Regarding claim 28, patent claim 13 specifies substantially free of immunosuppressants.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/ Primary Examiner, Art Unit 1632
Prosecution Insights