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 .
Priority
This application filed on 10/19/2023, is a national phase application under 35 U.S.C. § 371 of International Application No. PCT/CN2022/087872, filed on 04/20/2022, which claims the priority of Chinese Patent Application No. 202110436177.6, filed on 04/22/2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 10/19/2023, 01/29/2025, 05/27/2025 and 12/03/2025, complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
Status of claims
The preliminary amendment filed on 01/30/2025, that cancelled claims 1-7, amended claim 8 and added claims 9-15, is acknowledged. Claims 8-15 are pending.
Claim interpretation
Examination requires claim terms first be construed in terms in the broadest reasonable manner during prosecution as is reasonably allowed in an effort to establish a clear record of what applicant intends to claim. See MPEP § 2111. Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. See MPEP § 2111.01. It is also appropriate to look to how the claim term is used in the prior art, which includes prior art patents, published applications, trade publications, and dictionaries. MPEP § 2111.01 (III). However, specific embodiments of the specification cannot be imported into the claims, particularly where the subject claim limitation is broader than the embodiment. MPEP § 2111.01(II).
Claim interpterion of “preventing” and “ameliorating”
Claim 8 recites “A method for treating/preventing/ameliorating an autoimmune skin disease, comprising administering a therapeutically effective amount of JAK3/JAK1/TBK1 selective inhibitor to a subject in need thereof”.
The instant specification does not provide definition to the terms. Nevertheless, the instant specification recites:
“Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art. [0043]”
As provided in MPEP 211.01 III, [T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips v. AWH Corp.,415 F.3d 1303, 1313, 75 USPQ2d 1321, 1326 (Fed. Cir. 2005) (en banc); Sunrace Roots Enter. Co. v. SRAM Corp., 336 F.3d 1298, 1302, 67 USPQ2d 1438, 1441 (Fed. Cir. 2003); Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 334 F.3d 1294, 1298, 67 USPQ2d 1132, 1136 (Fed. Cir. 2003) ("In the absence of an express intent to impart a novel meaning to the claim terms, the words are presumed to take on the ordinary and customary meanings attributed to them by those of ordinary skill in the art."). Where neither the claims, nor the specification, nor the prosecution history offer sufficient clarity on claim scope, extrinsic evidence may become a necessary part of claim interpretation. Moreover, MPEP 2111.01 stated that it is improper to “read limitations into a claim from the preferred embodiment described in the specification, even if it is the only embodiment described, absent clear disclaimer in the specification."
Thus, claim 8 term “prevent” is given its plain meaning knowing in the art. In the art the term “prevent” with respect to a disease or disorder generally means an “action taken to decrease the chance of getting a disease or condition”. See e.g., D. Walker et al., 32 Cancer Causes & Control, 919-922 (2021) (at page 921, citing NIH, National Cancer Institute Dictionary: prevention (2020), Webpage. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/prevention. Accessed 13 Oct 2020).
Claim 8 term “ameliorating” is given its plain meaning as described by medical dictionary as “lessened signs or symptoms of a disease.” (Ameliorate | definition of ameliorate by Medical dictionary, (2012) https://medical-dictionary.thefreedictionary.com/ameliorate).
Claim 8 recites “… administering a therapeutically effective amount of JAK3/JAK1/TBK1 selective inhibitor…”.
Instant specification defines “therapeutically effective amount” as:
In the present disclosure, the "therapeutically/prophylactically/amelioratively effective amount" refers to the dose between minimum effective dose and the extreme dose, which can produce a significant effect on the body without causing a toxic reaction. [0033].
thus, therapeutically effective amount is interpreted consistent with the instant specification.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 8-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by S. Shan, et al. International Immunopharmacology, Volume 77, 2019, 105914, ISSN 1567-5769, “Shan” cited in the IDS dated 10/19/2023) as evidenced by Z. Xie et al. Journal of Medicinal Chemistry, January 22, 2021 Vol 64, Issue 3, P 1283- 1345, “Xie” cited in the PTO-892).
Shan discloses a method of treating rheumatoid arthritis by administering CS12192, a novel selective JAK3/JAK1/TBK1 inhibitor, wherein oral treatment with CS12192 ameliorated the disease severity, hind paw swelling, body weight loss, and bone destruction. [Abstract]. Shan discloses that the 80mg/kg of CS12192 is administered twice a day, [page 2, col. 2, last para.]. CS12192 is N-(3-((5-chloro-2-((4-fluoro-3-(N-methylacrylamido)phenyl) amino)-4-pyrimidinyl)amino)propyl)-4-cyanobenzamide, as evidence by Xie, [Xie, Figure 4, comp. (26)]:
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Shan’s administration of CS12192 would necessarily be functioning for the “prevention” (per independent claim 8) of the diseases recited in the claim, autoimmune skin disease. That is, per Claim Interpretation above, Shan’s administration of CS12192 would necessarily/inherently be decreasing the chance of that subject, rats/mice getting the listed disease condition. MPEP § 2112.
per claim 8 Shan administers “a therapeutically effective amount” (see Claim Interpretation above).
In view of the foregoing, Shan’s administration of CS12192 in an amount of 80mg/kg twice a day (“a therapeutically effective amount”) to the rats/mice meets each and every limitation of claim 8 method of preventing an autoimmune disease, and therefore anticipates claims 8, 13, 14, and 15.
Shan’s CS12192 anticipates claims 9, 10, and 11.
Shan’s administration of 80mg/kg of CS12192 twice a day anticipates claim 12 because administering 80mg/kg twice a day is equivalent to 24mg/time/day (80mg/kg x 0.15kg1 (weight of rat in kg) = 12 mg x 2 (twice a day) = 24 mg per day.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 8 and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over S. Shan, et al. International Immunopharmacology, Volume 77, 2019, 105914, ISSN 1567-5769, “Shan” cited in the IDS dated 10/19/2023) in view of Z. Xie et al. Journal of Medicinal Chemistry, January 22, 2021 Vol 64, Issue 3, P 1283- 1345, “Xie” cited in the PTO-892) H. He et al. American Journal of Clinical Dermatology (2019) 20:181–192, “He” cited in the PTO-892), and C. Garcia-Melendo et al. (Actas Dermosifiliogr. 19 march 2021; 112:503-515, “Garcia-Melendo” cited in the IDS dated 01/29/2025).
Shan teaches a method of treating autoimmune disease by administering CS12192. [Abstract]. Shan teaches that CS12192 identified as a novel selective JAK inhibitor, with a potent inhibition on JAK3, and to a less extent on JAK1 and TBK1. [page 2, col. 1, 3rd para.].
Shan teaches that JAK3 is more restrictedly expressed in hematopoietic cells and mediates signals through the common γ chain shared by many immune related cytokine receptors [page 1, col. 2 last para.].
Shan teaches that “Considering that JAKs are essential signaling mediators downstream of many pro inflammatory cytokine receptors, small molecule inhibitors of JAKs have gained attraction as safe and efficacious options for the treatment of inflammation-driven pathologies such as Rheumatoid arthritis and psoriasis.” [page 2, col. 1, 1st para.].
Shan teaches that CS12192 showed more selective JAK3 inhibition with an IC50 of 11nM, and to a less extent of JAK1 inhibition with an IC50 of 105nM, and interestingly, CS12192 inhibited TBK1 and Flt4 with the IC50 of 162nM and 107nM, respectively. [page 4, col. 2, 1st para.]. Shan teaches that the results also showed that CS12192 is also a novel dual JAK/TBK1 inhibitor. [page 4, 2nd -3rd para.].
Shan teaches that CS12192 affects cytokine production of CD4+ T, and CS12192 significantly inhibited the serum levels of pro-inflammatory cytokines and/or differentiation-related cytokines. [page 6, col. 1, last para.].
Shan teaches that a novel selective JAK inhibitor, CS12192 is investigated for the treatment of Rheumatoid arthritis because several JAK inhibitors have been approved for the treatment of Rheumatoid arthritis such as tofacitinib, a JAK3/JAK1/JAK2 inhibitor, has been approved by FDA for the treatment of Rheumatoid arthritis patients, and JAK1/JAK2 inhibitor, baricitinib, was approved for the treatment of moderate-to-severe Rheumatoid arthritis patients. [page 2, col. 1, 1st and 3rd para.].
CS12192 is N-(3-((5-chloro-2-((4-fluoro-3-(N-methylacrylamido)phenyl) amino)-4-pyrimidinyl)amino)propyl)-4-cyanobenzamide, as explained in the 102 Rejection above:
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While Shan teaches the potency of CS12192 as selective JAK3/JAK1/TBK1 inhibitor, The effect of CS12192 on cytokine production of CD4+ T, and on inhibition of the pro-inflammatory cytokine serum levels, and the effectiveness of CS12192 in treating autoimmune disease and inflammation-driven pathologies such as Rheumatoid arthritis, Shan does not teach that the autoimmune disease is autoimmune skin disease, atopic dermatitis or alopecia areata.
Xie teaches the use of JAK inhibitors for treatment of nononcologic diseases including autoimmune diseases, atopic dermatitis and alopecia areata. [Abstract], [Table 1]. Xie teaches that several JAK inhibitors have been approved for the treatment of autoimmune skin diseases. [page 1287, col. 1, 2nd para.]:
Ruxolitinib, a JAK1/JAK2 selective inhibitor, with effective a safe, well-tolerated profile for treating atopic dermatitis and alopecia areata, [page 1287, col. 1, 3rd para.].
Tofacitinib, a selective JAK3 inhibitor, approved by the U.S. FDA in 2012 to treat atopic dermatitis and alopecia areata, [page 1287, col. 1, last para.];
Oclacitinib, a JAK inhibitor, approved by the U.S. FDA in 2013 for the treatment of atopic dermatitis, [page 1287, col. 1, 2nd para.];
Delgocitinib, an effective and well tolerated JAK1/JAK2/JAK3 inhibitor, was developed for the treatment of atopic dermatitis, [page 1288, col. 2, 1st para.];
Baricitinib, a selective inhibitor of JAK1/JAK2, received a breakthrough therapy designation from the U.S. FDA to treat alopecia areata, [page 1287, col. 2, 2nd para.].
Baricitinib, JAK1/JAK2 inhibitor, approved by the U.S. FDA for treating atopic dermatitis, [page 1285, Table 1];
Upadacitinib, selective JAK1 inhibitor, approved by the U.S. FDA for treating atopic dermatitis, [page 1285, Table 1];
PF-06651600, selective JAK3 inhibitor, in clinical trials for treating alopecia areata, [page 1289, Table 2];
Abrocitinib, a selective JAK1 inhibitor, in clinical trials for treating atopic dermatitis, [page 1289, Table 2].
Xie teaches that CS12192, a possible irreversible JAK inhibitor is in phase 1 clinical trial. Xie teaches that CS12192 is superior to other JAK inhibitors because CS12192 selectively inhibits JAK3 (IC50 = 11nM) over JAK1, JAK2, and TYK2, demonstrated good therapeutic results, and has an IC50 value of 162nM against TANK-binding kinase1, which was found to play a role in RANKL-induced NF-κB activation. [page 1289, col. 1, 1st para.].
He teaches the use for JAK inhibitors for treating atopic dermatitis. [Title]. He efficacy of many different JAK inhibitors for the treatment of atopic dermatitis including Tofacitinib, selective against JAK1 and JAK3; Baricitinib, a JAK1 and JAK2 inhibitor; Upadacitinib, a selective JAK1 inhibitor; Abrocitinib, selective oral JAK1 inhibitor; ruxolitinib, JAK1/JAK2 inhibitor; Delgocitinib a JAK1/JAK2/JAK3/TYK2) inhibitor; and SNA-125, a JAK3/TrkA inhibitor. [page 183-185].
He teaches that Information regarding the safety of JAK inhibitors largely comes from studies in other inflammatory diseases, such as rheumatoid arthritis. [page 186, col. 1, 2nd para.]. He teaches that JAK inhibitors showed efficacy in treating atopic dermatitis with acceptable safety profiles. [page 186, col. 2, last para.].
One of He’s JAK inhibitor, is SNA-125, a selective JAK3 inhibitor. He teaches that because SNA-125 inhibiting JAK3, SNA-125 blocks signaling via IL-4 and other cytokines, and also blocks TrkA, a high affinity receptor for nerve growth factor (NGF), which mediates neurogenic inflammation and itch. [page 186, col. 1, 1st para.].
Garcia-Melendo teaches the use of JAK inhibitors for treating alopecia areata. [Abstract]. Garcia-Melendo teaches the connection between alopecia areata and JAK3, wherein analysis of skin biopsies from patients with alopecia areata has revealed overexpression of JAK3 and, albeit to a lesser extent, JAK1 and JAK2. [page 510, col. 2, 1st para.]. Garcia-Melendo teaches that the role of JAK in the pathogenesis of alopecia areata, the direct effect of JAK inhibitor on follicles during the telogen phase and promotion of anagen phase makes JAK inhibitors effective treatment for alopecia areata, [page 510, col. 2, 2nd para.].
Garcia-Melendo teaches many JAK inhibitors for the treatment of alopecia areata including tofacitinib, ruxolitinib, Baricitinib, delgocitinib, ritlecitinib and brepocitinib. [page 510- 511].
In view of the foregoing discussion, it would have been prima facie obvious to one of ordinary skill in the prior to the effective filing date of instantly claimed invention to use JAK inhibitor, CS12192 for treating autoimmune skin diseases i.e., atopic dermatitis and alopecia areata. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because: treating atopic dermatitis and alopecia areata with JAK inhibitors is well-known in the art as taught by the cited prior art of Xie, He and Garcia-Melendo, and CS12192 is a selective potent and safe JAK inhibitor as taught by Shan and Xie.
As discussed above, Xie, He and Garcia-Melendo teach many JAK inhibitors FDA approved/in clinical trials are used for the treatment of atopic dermatitis and alopecia areata including ruxolitinib, JAK1/JAK2 selective inhibitor, Tofacitinib, a selective JAK3 inhibitor, Oclacitinib, a JAK inhibitor, Delgocitinib, JAK1/JAK2/JAK3 inhibitor, Baricitinib, a selective inhibitor of JAK1/JAK2, Baricitinib, JAK1/JAK2 inhibitor, Upadacitinib, selective JAK1 inhibitor, PF-06651600, selective JAK3 inhibitor, Abrocitinib, a selective JAK1 inhibitor, which would motivate one of ordinary skill in the art to use another JAK inhibitor i.e., CS12192 for treating atopic dermatitis and alopecia areata. One of ordinary skill in the art would have been motivated to specifically utilize CS12192 in treating atopic dermatitis and alopecia areata because: Shan teaches using CS12192 in a method of treating autoimmune disease; Shan teaches that CS12192 identified as a novel selective JAK inhibitor; CS12192 showed more selective JAK3 inhibition with an IC50 of 11nM, and to a less extent of JAK1 inhibition with an IC50 of 105nM; CS12192 inhibited TBK1 and Flt4; CS12192 is a novel dual JAK/TBK1 inhibitor; CS12192 affects cytokine production of CD4+ T, and CS12192 significantly inhibited the serum levels of pro-inflammatory cytokines; Xie teaches that CS12192, a possible irreversible JAK inhibitor; CS12192 is superior to other JAK inhibitors because CS12192 selectively inhibits JAK3 (IC50 = 11nM) over JAK1, JAK2, and TYK2; CS12192 demonstrated good therapeutic results. Moreover, He teaches that the safety of JAK inhibitors largely comes from studies in other inflammatory diseases, such as RA and the safety and efficacy of CS12192 in RA is taught by Shan. Furthermore, Garcia-Melendo teaches the correlation between alopecia areata and overexpression of JAK3 and, albeit to a lesser extent, JAK1 and JAK2, which would motivate skilled artisan to use CS12192 because the potency and JAK3 selectivity of CS12192. Case law has established that it is prima facie obvious to substitute one known elementfor another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007). The cited prior arts provide one of ordinary skill in the art with the requisite predictability in using CS12192 for treating atopic dermatitis and alopecia areata.
Therefore, the combination of Shan, Xie, He, and Garcia-Melendo teaches each and every limitation of claims 8, 9, 10, 11, 13, 14 and 15.
Shan’s administration of 80mg/kg of CS12192 twice a day meets claim 12 because administering 80mg/kg twice a day is equivalent to 24mg/time/day (80mg/kg x 0.15kg2 (weight of rat in kg) = 12 mg x 2 (twice a day) = 24 mg per day.
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.
Non-statutory Double Patenting over US Patent No. US10011571B2
Claims 8-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of US Patent No. 10011571B2 in view of S. Shan, et al. International Immunopharmacology, Volume 77, 2019, 105914, ISSN 1567-5769, “Shan” cited in the IDS dated 10/19/2023), Z. Xie et al. Journal of Medicinal Chemistry, January 22, 2021 Vol 64, Issue 3, P 1283- 1345, “Xie” cited in the PTO-892) H. He et al. American Journal of Clinical Dermatology (2019) 20:181–192, “He” cited in the PTO-892), and C. Garcia-Melendo et al. (Actas Dermosifiliogr. 2021; 112:503-515, “Garcia-Melendo” cited in the IDS dated 01/29/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 8-15 recites A method for treating/preventing/ameliorating an autoimmune skin disease, comprising administering a therapeutically effective amount of JAK3/JAK1/TBK1 selective inhibitor to a subject in need thereof, wherein the JAK3/JAK1/TBK1 selective inhibitor is N-(3-((5-chloro-2-((4-fluoro-3-(N-methylacrylamido)phenyl)amino)-4-pyrimidinyl) amino)propyl)-4- cyanobenzamide, wherein the JAK3/JAK1/TBK1 selective inhibitor is administered in a dosage of 20-600 mg/time/day, wherein the autoimmune skin disease is atopic dermatitis and alopecia areata.
US Patent No. 10011571B2 recites in claims 1 and 17-20 a compound of formula (I) and a method of using a compound of formula (I) in treating a disease related to abnormal activities of JAK3 and/or JAK1 kinases, wherein the disease is selected from the group consisting of autoimmune diseases, rheumatoid arthritis, psoriasis, and claim 8 recites N-(3-((5-chloro-2-((4-fluoro-3-(N-methylacrylamido)phenyl)amino)-4-pyrimidinyl) amino)propyl)-4- cyanobenzamide (claimed compound) as species of formula (I).
While US Patent No. 10011571B2 recites using N-(3-((5-chloro-2-((4-fluoro-3-(N-methylacrylamido)phenyl)amino)-4-pyrimidinyl) amino)propyl)-4- cyanobenzamide (claimed compound) in treating a disease related to abnormal activities of JAK3 and/or JAK1 kinases, and recites that the disease is an autoimmune disease, US Patent No. 10011571B2 does not recite that the autoimmune disease is an autoimmune skin disease.
The court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). US Patent No. 10011571B2 specification recites that compound of formula (I) are JAK3 and/or JAK1 inhibitors.
Shan, Xie, He and Garcia-Melendo teach as discussed above.
The obviousness rationale is the same as the rationale of the 103 Rejection above, page 10-11.
With regard to claim 12, US Patent No. 10011571B2 recites in claim 15 and 21, a pharmaceutical composition comprising the compound of formula (I) in an amount ranging from 0.0001 to 200 mg.
US Patent No. 10011571B2 amount overlapped with the claimed amount of 20-600mg/time/day. As proved in MPEP 2144.05, in the case where 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). "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005) (claimed alloy held obvious over prior art alloy that taught ranges of weight percentages overlapping, and in most instances completely encompassing, claimed ranges; furthermore, narrower ranges taught by reference overlapped all but one range in claimed invention). Moreover, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Non-statutory Double Patenting over Co-pending Application No. 17/780,284
Claims 8-15 are provisional rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 20 and 21 of Co-pending Application No. 17/780,284 (US PG-PUB 2023/0000863A1) in view of S. Shan, et al. International Immunopharmacology, Volume 77, 2019, 105914, ISSN 1567-5769, “Shan” cited in the IDS dated 10/19/2023), Z. Xie et al. Journal of Medicinal Chemistry, January 22, 2021 Vol 64, Issue 3, P 1283- 1345, “Xie” cited in the PTO-892) H. He et al. American Journal of Clinical Dermatology (2019) 20:181–192, “He” cited in the PTO-892), and C. Garcia-Melendo et al. (Actas Dermosifiliogr. 2021; 112:503-515, “Garcia-Melendo” cited in the IDS dated 01/29/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 8-15 recites A method for treating/preventing/ameliorating an autoimmune skin disease, comprising administering a therapeutically effective amount of JAK3/JAK1/TBK1 selective inhibitor to a subject in need thereof, wherein the JAK3/JAK1/TBK1 selective inhibitor is N-(3-((5-chloro-2-((4-fluoro-3-(N-methylacrylamido)phenyl)amino)-4-pyrimidinyl) amino)propyl)-4- cyanobenzamide, wherein the JAK3/JAK1/TBK1 selective inhibitor is administered in a dosage of 20-600 mg/time/day, wherein the autoimmune skin disease is atopic dermatitis and alopecia areata.
Co-pending Application No. 17/780,284 recites in claim 1 a composition comprising N-(3-((5-chloro-2-((4-fluoro-3-(N-methylacrylamido)phenyl)amino)-4-pyrimidinyl)amino)propyl)-4-cyanobenzamide (claimed compound) and a carrier, claim 9 recites that the composition has a unit dose of 5 to 200 mg, and claims 20 and 21 recite a method of treating a disease, comprising administering to a subject in need thereof a therapeutically effective amount of the composition according to claim 1, wherein the disease is an autoimmune disease.
While Co-pending Application No. 17/780,284 recites using N-(3-((5-chloro-2-((4-fluoro-3-(N-methylacrylamido) phenyl) amino)-4-pyrimidinyl) amino) propyl)-4- cyanobenzamide (claimed compound) in treating autoimmune diseases, Co-pending Application No. 17/780,284 does not recite that the autoimmune disease is an autoimmune skin disease.
The court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). Co-pending Application No. 17/780,284 specification recites that the compound of claim 1 is an inhibitor of JAK3/JAK1/TYK2/JAK2, and can be used for the treatment and/or prevention of an autoimmune disease, inflammatory disease. [Instant specification, page 1-2].
Shan, Xie, He and Garcia-Melendo teach as discussed above.
The obviousness rationale is the same as the rationale of the 103 Rejection above, page 10-11.
With regard to claim 12, Co-pending Application No. 17/780,284 recites in claim 9, the compound of claim 1 has a unit dose of 5 to 200 mg.
US Patent No. 10011571B2 amount overlapped with the claimed amount of 20-600mg/time/day. As proved in MPEP 2144.05, in the case where 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). "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005) (claimed alloy held obvious over prior art alloy that taught ranges of weight percentages overlapping, and in most instances completely encompassing, claimed ranges; furthermore, narrower ranges taught by reference overlapped all but one range in claimed invention). Moreover, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
Claims 8-15 are rejected. No claim is allowed.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
1 Weight of rat in kg (S. Reagan-Shaw et al. (2008), The FASEB Journal, 22: 659-661, page 660, Table 1).
2 Weight of rat in kg (S. Reagan-Shaw et al. (2008), The FASEB Journal, 22: 659-661, page 660, Table 1).