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 32-58 filed October 23, 2024 are currently pending.
Priority
Acknowledgement is made of the continuation of Application 16704402 , filed 12/05/2019 ,now U.S. Patent 12,076,323. Application 16704402 is a continuation of Application 16098338 , filed 11/01/2018, now U.S. Patent 10,561,659. Application 16098338 is a National Stage entry of PCT/US2017/031142 , International Filing Date: 05/04/2017. PCT/US2017/031142 claims Priority from U.S. Provisional Application 62331827, filed 05/04/2016.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/23/2024, 05/12/2025, 05/14/2025, 07/02/2025 and 10/08/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 37-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-21 of U.S. Patent No. 10,651,659.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Claims 1-7, 9-21 of U.S. Patent 10,561,659 are directed to the treatment of hair loss in a human subject comprising alopecia areata comprising oral administration of the same compound of Formula (I) or a phosphate salt thereof, in a dose of 16 mg/day or 24 mg/day, wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium. Said 16 mg/day administration of Formula (I) or phosphate salt to the human patient with alopecia areata thereof overlaps with the methodology of instant claims 37-52, while said 24 mg/day administration of Formula (I) to the human patient with alopecia areata reads on the methodology of claims 53-58.
Regarding the limitation wherein the SALT score improves in the human patient comprising alopecia areata and receiving either 16 mg/day or 24 mg/day of Formula (I) wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, or results in a plasma mean Cmax of 151 ng/mL to 492 ng/mL, a median Tmax of 0.75 hr to 1.50 hr and a mean AUC of 668 hr*ng/mL to 2104 hr*ng/mL after administration, Applicant is reminded that properties that accrue from a process step of administering either 16 mg/day or 24 mg/day of Formula (I) or phosphate salt to the human patient with alopecia areata are considered characteristic features of the claimed methodology.
It is noted that MPEP 2112 discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
In the present case the burden is shifted to Applicant to prove that the SALT score does not improve in the human patient comprising alopecia areata following receiving either 16 mg/day or 24 mg/day of Formula (I) wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium as recited in claims 1-7 and 9-21 of U.S. Patent 10,561,659, nor does not yield a plasma mean Cmax of 151 ng/mL to 492 ng/mL, a median Tmax of 0.75 hr to 1.50 hr and a mean AUC of 668 hr*ng/mL to 2104 hr*ng/mL after administration.
Claims 37-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12,076,323.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Claims 1-29 of U.S. Patent 12,076,323 are directed to the treatment of hair loss in a human subject comprising alopecia areata comprising oral administration of the same compound of Formula (I) or a phosphate salt thereof, in a dose of 16 mg once a day or 8 mg twice a day, wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium. Said 16 mg/day administration of Formula (I) or phosphate salt to the human patient with alopecia areata thereof overlaps with the methodology of instant claims 37-52.
Regarding the limitation wherein the SALT score improves in the human patient comprising alopecia areata and receiving either 16 mg/day of Formula (I) wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, or results in a plasma mean Cmax of 151 ng/mL to 492 ng/mL, a median Tmax of 0.75 hr to 1.50 hr and a mean AUC of 668 hr*ng/mL to 2104 hr*ng/mL after administration, Applicant is reminded that properties that accrue from a process step of administering either 16 mg/day of Formula (I) or phosphate salt to the human patient with alopecia areata are considered characteristic features of the claimed methodology.
It is noted that MPEP 2112 discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
In the present case the burden is shifted to Applicant to prove that the SALT score does not improve in the human patient comprising alopecia areata following receiving either 16 mg/day of Formula (I) wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium as recited in claims 1-29 of U.S. Patent 12,076,323 nor does not yield a plasma mean Cmax of 151 ng/mL to 492 ng/mL, a median Tmax of 0.75 hr to 1.50 hr and a mean AUC of 668 hr*ng/mL to 2104 hr*ng/mL after administration.
Claims 32-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 8-10, 12, 15-17, 19, 22-24 and 26 of U.S. Patent No. 12,285,432.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Claims 1, 8 15 and 22 15 of U.S. Patent 12,285,432 are directed to the treatment of hair loss in a human subject comprising alopecia areata comprising oral administration of the same compound of Formula (I) or a phosphate salt thereof, in a dose of 4 mg to 50 mg, wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, wherein said compound of Formula (I) is further administered with 0.1 -200 mg of a CYP3A4 inhibitor. Said 4 mg to 50 mg dose of Formula (I) overlaps with the amount of Formula (I) administered in claims 32-58. Applicant is reminded of MPEP 2144.05 wherein the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Applicant is also reminded that the present claims embrace the transitional phrase “comprising” which in view of MPEP 2111.03 is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). In the present case, the instant claims do not exclude additional unrecited elements, such as a CYP3A4 inhibitor.
Claims 2-3, 9-10, 16-17 and 23-24 of U.S. Patent 12,285,432 narrows the dose of Formula (I) to 16 mg/day or 24 mg/day administration of Formula (I) or phosphate salt to the human patient with alopecia areata thereof, wherein said dose is either 8 mg twice-a-day or 12 mg twice-a-day. Said dosing amounts and dosing frequency of Formula (I) in U.S. Patent 12,285,432 overlaps with the methodology of instant claims 37-52, while said 24 mg/day administration of Formula (I) to the human patient with alopecia areata reads on the methodology of claims 53-58. Claims 5, 12, 19 and 26 are directed to wherein the dosing of Formula (I) results improvement in the SALT score of the subject, wherein the SALT score is less than or equal to 20 after treatment with Formula (I).
Regarding the limitation wherein the SALT score improves in the human patient comprising alopecia areata and receiving either 16 mg/day or 24 mg/day of Formula (I) wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, or results in a plasma mean Cmax of 151 ng/mL to 492 ng/mL, a median Tmax of 0.75 hr to 1.50 hr and a mean AUC of 668 hr*ng/mL to 2104 hr*ng/mL after administration, Applicant is reminded that properties that accrue from a process step of administering either 16 mg/day or 24 mg/day of Formula (I) or phosphate salt to the human patient with alopecia areata are considered characteristic features of the claimed methodology.
It is noted that MPEP 2112 discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
In the present case the burden is shifted to Applicant to prove that the SALT score does not improve in the human patient comprising alopecia areata following receiving either 16 mg/day or 24 mg/day of Formula (I) wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, or does not yield a plasma mean Cmax of 151 ng/mL to 492 ng/mL, a median Tmax of 0.75 hr to 1.50 hr and a mean AUC of 668 hr*ng/mL to 2104 hr*ng/mL after administration.
Claims 37-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-11, 14-17, 20 and 25-30 of U.S. Patent No. 12,364,699.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Claims 1, 14-17, 20 and 30 of U.S. Patent 12,364,699 are directed to the treatment of hair loss in a human subject comprising alopecia areata comprising oral administration of the same compound of Formula (I) or a pharmaceutically acceptable salt thereof, in a dose of 16 mg/day or 24 mg/day, wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium. Said 16 mg/day administration of Formula (I) or phosphate salt to the human patient with alopecia areata thereof overlaps with the methodology of instant claims 37-52, while said 24 mg/day administration of Formula (I) to the human patient with alopecia areata reads on the methodology of claims 53-58.
Claims 5-11 and 25-29 of U.S. Patent 12,364,699 are directed to wherein the SALT score of the subject with alopecia areata is ≤ 20 after 8 weeks of treatment, or has a salt score of ≤ 20 after 8, 12, 24 or 52 weeks of treatment, which overlaps with the methodology of instant claims 37-51.
Regarding the limitation wherein the SALT score improves in the human patient comprising alopecia areata and receiving either 16 mg/day or 24 mg/day of Formula (I) wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, or results in a plasma mean Cmax of 151 ng/mL to 492 ng/mL, a median Tmax of 0.75 hr to 1.50 hr and a mean AUC of 668 hr*ng/mL to 2104 hr*ng/mL after administration, Applicant is reminded that properties that accrue from a process step of administering either 16 mg/day or 24 mg/day of Formula (I) or phosphate salt to the human patient with alopecia areata are considered characteristic features of the claimed methodology.
It is noted that MPEP 2112 discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
In the present case the burden is shifted to Applicant to prove that the SALT score does not improve in the human patient comprising alopecia areata following receiving either 16 mg/day or 24 mg/day of Formula (I) wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, or does not yield a plasma mean Cmax of 151 ng/mL to 492 ng/mL, a median Tmax of 0.75 hr to 1.50 hr and a mean AUC of 668 hr*ng/mL to 2104 hr*ng/mL after administration.
Claims 32-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9, 13-20 of copending Application No. 18033730 (notice of allowance 06/09/2026).
Claim 1 of copending Application 18033730 is directed to the treatment of hair loss in a human subject comprising alopecia areata comprising oral administration of the same compound of Formula (I) or a phosphate salt thereof wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, in a dose of 8-32 mg/day for a duration of 8-24 weeks, followed by a second period of at least 8 weeks, wherein the administered amount per day is 50-75% of the amount per day administered in the first period. Said 8 mg to 32 mg dose per day of Formula (I) to a human patient with alopecia areata overlaps with the amount of Formula (I) administered in claims 37-58 as well as the patient population treated. Applicant is reminded of MPEP 2144.05 wherein the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In addition, given the broadest reasonable interpretation of the claims, claim 1 of copending Application 18033730 also embraces administering 4 mg/day of Formula (I) (50% reduction of the 8 mg/day range), which overlaps with the dosage of instant claims 32-36.
In addition, said 16 mg/day or 24 mg/day administration of Formula (I) or phosphate salt to the human patient with alopecia areata thereof in claim 4 overlaps with the methodology of instant claims 37-52, while said 24 mg/day administration of Formula (I) to the human patient with alopecia areata reads on the methodology of claims 53-58. Claims 13-14 embrace the administration of Formula (I) for a first period of 8-24 weeks, which overlaps with the duration found in instant claims 37-53. Claims 18-20 of copending Application 18033730 are directed to wherein the SALT score of the subject with alopecia areata is ≤ 20 after 8 weeks of treatment, or has a salt score of ≤ 20 after 16 weeks of treatment, which overlaps with the methodology of instant claims 37-51.
Regarding the limitation wherein the SALT score improves in the human patient comprising alopecia areata and receiving either 16 mg/day or 24 mg/day of Formula (I) wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, or results in a plasma mean Cmax of 151 ng/mL to 492 ng/mL, a median Tmax of 0.75 hr to 1.50 hr and a mean AUC of 668 hr*ng/mL to 2104 hr*ng/mL after administration, Applicant is reminded that properties that accrue from a process step of administering either 16 mg/day or 24 mg/day of Formula (I) or phosphate salt to the human patient with alopecia areata are considered characteristic features of the claimed methodology.
It is noted that MPEP 2112 discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
In the present case the burden is shifted to Applicant to prove that the SALT score does not improve in the human patient comprising alopecia areata following receiving either 16 mg/day or 24 mg/day of Formula (I) wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, or does not yield a plasma mean Cmax of 151 ng/mL to 492 ng/mL, a median Tmax of 0.75 hr to 1.50 hr and a mean AUC of 668 hr*ng/mL to 2104 hr*ng/mL after administration.
Claims 32-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 12-15 of copending Application No. 18862131.
Claim 1 of copending Application 18862131 is directed to the treatment of hair loss in a human subject comprising oral administration of the same compound of Formula (I) or a phosphate salt thereof wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, in a dose of 8-32 mg/day for a duration of 8-24 weeks, followed by a second period of at least 8 weeks, wherein the administered amount per day is 50-75% of the amount per day administered in the first period. Said 8 mg to 32 mg dose per day of Formula (I) to a human patient with a hair loss disorder overlaps with the amount of Formula (I) administered in claims 37-58 as well as the patient population treated. Applicant is reminded of MPEP 2144.05 wherein the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In addition, given the broadest reasonable interpretation of the claims, claim 1 of copending Application 18862131 also embraces administering 4 mg/day of Formula (I) (50% reduction of the 8 mg/day range), which overlaps with the dosage of instant claims 32-36.
In addition, said 16 mg/day or 24 mg/day administration of Formula (I) or phosphate salt to the human patient with alopecia areata thereof in claim 4 overlaps with the methodology of instant claims 37-52, while said 24 mg/day administration of Formula (I) to the human patient with alopecia areata reads on the methodology of claims 53-58. Claims 12-15 embrace the administration of Formula (I) for a first period of 8-24 weeks, which overlaps with the duration found in instant claims 37-53.
Regarding the limitation wherein the SALT score improves in the human patient comprising alopecia areata and receiving either 16 mg/day or 24 mg/day of Formula (I) wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, or results in a plasma mean Cmax of 151 ng/mL to 492 ng/mL, a median Tmax of 0.75 hr to 1.50 hr and a mean AUC of 668 hr*ng/mL to 2104 hr*ng/mL after administration, Applicant is reminded that properties that accrue from a process step of administering either 16 mg/day or 24 mg/day of Formula (I) or phosphate salt to the human patient with alopecia areata are considered characteristic features of the claimed methodology.
It is noted that MPEP 2112 discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
In the present case the burden is shifted to Applicant to prove that the SALT score does not improve in the human patient comprising alopecia areata following receiving either 16 mg/day or 24 mg/day of Formula (I) wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, or does not yield a plasma mean Cmax of 151 ng/mL to 492 ng/mL, a median Tmax of 0.75 hr to 1.50 hr and a mean AUC of 668 hr*ng/mL to 2104 hr*ng/mL after administration.
Claims 32-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29, 33-34 ,37, 41 of copending Application No. 19088476.
Claims 29, 37 and 41 of copending Application 19088476 are directed to the treatment of hair loss in a human subject comprising alopecia areata comprising oral administration of the same compound of Formula (I) or a phosphate salt thereof, in a dose of 4 mg to 50 mg, wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, wherein said compound of Formula (I) is further administered with 0.1 -200 mg of a CYP3A4 inhibitor. Said 4 mg to 50 mg dose of Formula (I) overlaps with the amount of Formula (I) administered in claims 32-58. Applicant is reminded of MPEP 2144.05 wherein the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Applicant is also reminded that the present claims embrace the transitional phrase “comprising” which in view of MPEP 2111.03 is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). In the present case, the instant claims do not exclude additional unrecited elements, such as a CYP3A4 inhibitor.
Claims 33-34 and 53-54 of copending Application 19088476 narrow the dose of Formula (I) to 16 mg/day or 24 mg/day administration of Formula (I) or phosphate salt to the human patient with alopecia areata thereof, wherein said dose is either 8 mg twice-a-day or 12 mg twice-a-day. Said dosing amounts and dosing frequency of Formula (I) in U.S. Patent 12,285,432 overlaps with the methodology of instant claims 37-52, while said 24 mg/day administration of Formula (I) to the human patient with alopecia areata reads on the methodology of claims 53-58. Claims 5, 12, 19 and 26 are directed to wherein the dosing of Formula (I) results improvement in the SALT score of the subject, wherein the SALT score is less than or equal to 20 after treatment with Formula (I).
Regarding the limitation wherein the SALT score improves in the human patient comprising alopecia areata and receiving either 16 mg/day or 24 mg/day of Formula (I) wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, or results in a plasma mean Cmax of 151 ng/mL to 492 ng/mL, a median Tmax of 0.75 hr to 1.50 hr and a mean AUC of 668 hr*ng/mL to 2104 hr*ng/mL after administration, Applicant is reminded that properties that accrue from a process step of administering either 16 mg/day or 24 mg/day of Formula (I) or phosphate salt to the human patient with alopecia areata are considered characteristic features of the claimed methodology.
It is noted that MPEP 2112 discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
In the present case the burden is shifted to Applicant to prove that the SALT score does not improve in the human patient comprising alopecia areata following receiving either 16 mg/day or 24 mg/day of Formula (I) wherein each position in Formula (I) designated specifically as deuterium has at least 95% incorporation of deuterium, or does not yield a plasma mean Cmax of 151 ng/mL to 492 ng/mL, a median Tmax of 0.75 hr to 1.50 hr and a mean AUC of 668 hr*ng/mL to 2104 hr*ng/mL after administration.
Conclusion
In view of the rejections set forth above, no claim is allowed.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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