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 .
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 10/15/2025 was considered by the examiner, except where lined through.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 4 recite the limitation "the proton pump inhibitor" in “the method of claim 1”. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not include a “proton pump inhibitor” in the claim limitations, so Claims 3 and 4 referencing “the proton pump inhibitor” of Claim 1 lacks proper antecedent basis.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 states:
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The statement “significant clinical improvement as characterized by % effect on body surface area” is determined to be indefinite because it is unclear if any effect is significant, or it the % effect needs to be of a certain magnitude.
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 (i.e., changing from AIA to pre-AIA ) 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 1, 5, 7, 9, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over by Jin (Bohan Jin et al. “TYK2 Inhibitors and Uses Thereof”, WO 2020086616, Pub. Date: 04/30/2020, as cited on the IDS dated 10/15/2025).
Jin discloses Cyclopropanecarboxamide, N-[4-[[2-methoxy-3-[1-(methyl-d3)-1H-1,2,4-triazol-3-yl] phenyl] amino]-5-(1-oxopropyl-3,3,3-d3)-2-pyridinyl]- (ACI), herein Compound 1, see below, useful for treating TYK2-mediated disorders (Abstract and Pg. 299). Jin discloses oral administration of pharmaceutical compositions (Pg.146, [00395]).
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Jin discloses before administration of compounds in animal studies, the animals were fasted overnight (Pg. 274, [00757]).
Jin discloses “In some embodiments the disease or disorder is selected from type 1 diabetes, systemic lupus erythematosus, multiple sclerosis, psoriasis, Behcet's disease, POEMS syndrome, Crohn's disease, ulcerative colitis, and inflammatory bowel disease.” (Pg. 147, [00401]).
Jin discloses “For example, in specific embodiments, a compound described herein or a formulation containing the compound is administered for at least 2 weeks, about 1 month to about 5 years.” (Pg. 151, [00422]).
Jin discloses “For a 70 kg patient, dosages of from about 10 mg to about 200 mg of the compound disclosed herein would be more commonly used, depending on a subject’s physiological response.” (Pg. 147, [00396]). Jin also discloses “In some embodiments, the dose of compounds described herein for the described methods is about 1 to about 1000 mg/kg body weight of the subject being treated per day” (Pg. 147, [00397]).
The courts found that, 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) The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.
Regarding Claims 1, 5, 7, 9, and 15, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date, to utilize the method disclosed in Jin for treating TYK2-mediated disorders with TYK2 inhibitors such as compound 1, to arrive at the claimed limitations because it is known in the art, given the method, and compounds for treating TYK2 diseases to optimize the dosage range provided in Jin and arrive at the claimed dosage range. Dosage and treatment optimization are routine in the art.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Jin (Bohan Jin et al. “TYK2 Inhibitors and Uses Thereof”, WO 2020086616, Pub. Date: 04/30/2020, as cited on the IDS dated 10/15/2025) as applied to claim 1 above, and further in view of Bafutto (Mauro Bafutto et al., “Evaluation of psoriasis treatment with esomeprazole-a pilot study, Arq. Gastroenterol, Volume 56, Issue 3, Pub. Date: 30 September 2019).
See 35 USC 103 rejection above for Claim 1.
Jin does not teach proton pump inhibitors administered for treating a TYK2-mediated disease.
Bafutto teaches that proton pump inhibitors (PPIs) have anti-oxidant properties that directly effects neutrophils, monocytes, endothelial, and epithelial cells, that prevent inflammation (Abstract). The study evaluated the treatment of psoriasis with esomeprazole, a proton pump inhibitor, and shows the use of esomeprazole for treating psoriasis resulted in a significant reduction of (Psoriasis Area and Severity Index) PASI score and good clinical results (Abstract).
Regarding Claims 2 and 3, it would have been prima facie obvious for one of ordinary skill in the arts before the effective filing date, to combine the method disclosed in Jin for treating TYK2 mediated diseases, such as psoriasis with TYK2 inhibitors, with the method disclosed in Bafutto for treating psoriasis with proton pump inhibitor esomeprazole, because both compounds are taught by the prior art to be used to treat psoriasis. Administering proton pump inhibitor esomeprazole with a TYK2 inhibitor to treat the same disease is obvious.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Jin (Bohan Jin et al. “TYK2 Inhibitors and Uses Thereof”, WO 2020086616, Pub. Date: 04/30/2020, as cited on the IDS dated 10/15/2025) as applied to claim 1 above, and further in view of Bafutto (Mauro Bafutto et al., “Evaluation of psoriasis treatment with esomeprazole-a pilot study, Arq. Gastroenterol, Volume 56, Issue 3, Pub. Date: 30 September 2019) and Prakash (Amitabh Prakash et al., “Rabeprazole”, Adis New Drug Profile, Volume 55, Pgs. 261-267, Pub. Date: 27 November 2012).
See 35 USC 103 rejection above for Claim 1.
Jin and Bafutto do not teach rabeprazole as a proton pump inhibitor administered for treating psoriasis.
Prakash teaches Rabeprazole as a proton pump inhibitor, with 2 to 10-fold greater antisecretory activity than omeprazole in vitro. Prakash also teaches rabeprazole has a similar tolerability profile to omeprazole (Summary).
Regarding Claim 4, it would have been prima facie obvious for one of ordinary skill in the arts before the effective filing date to substitute the proton pump inhibitor omeprazole disclosed in Bafutto, with the proton pump inhibitor rabeprazole disclosed in Prakash, to arrive at the claimed limitations, because Prakash teaches that rabeprazole has greater antisecretory activity than omeprazole. Antisecretory activity is important because it protects the stomach lining from acid damage and prevents fluid loss during illnesses, one of ordinary skill would be motivated to use rabeprazole over omeprazole for the added patient benefits.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Jin (Bohan Jin et al. “TYK2 Inhibitors and Uses Thereof”, WO 2020086616, Pub. Date: 04/30/2020, as cited on the IDS dated 10/15/2025) as applied to Claim 1 above, and further in view of Culhane (James Culhane et al., “Targeted Therapy with Tyrosine Kinase Inhibitors”, US Pharmacology, Pub. Date: October 17, 2008).
See 35 USC 103 rejection above for Claim 1.
Jin does not teach administering food to the patient before administration of the compound.
Culhane teaches Tyrosine Kinase Inhibitors (TKIs) can be administered with or without food because clinical trial data and specific patient toxicities show no consistency between all TKIs (Pg. 12).
It would have been prima facie obvious for one of ordinary skill before the effective filing date to take the compound and method of use disclosed in Jin for treating TYK-2 mediated diseases, and combine them with the method disclosed in Culhane because both methods disclose uses for Tyrosine Kinase inhibitors. It would be obvious to optimize the treatment plan to include administering the compound with food, because Culhane teaches every TKI has its own recommendation based on clinical trials and specific patient toxicities.
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Jin (Bohan Jin et al. “TYK2 Inhibitors and Uses Thereof”, WO 2020086616, Pub. Date: 04/30/2020, as cited on the IDS dated 10/15/2025) as applied to Claim 1 above, and in further view of Nogueira (Miguel Nogueira et al., “JAK Inhibitors for Treatment of Psoriasis: Focus on Selective TYK2 Inhibitors”, Drugs, Volume 80, pgs. 341-353, Pub. Date: 04 February 2020).
Jin does not teach severe psoriasis as an embodiment, or a quantitative definition of severe psoriasis.
Nogueira teaches PF-06826647 as a selective TYK2 inhibitor being investigated for treating moderate-to-severe psoriasis in a Phase II clinical trial.
Regarding Claims 16-18, The court noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Claims 16-18 recite “significant clinical improvement” after administering the patient the compound to treat moderate to severe psoriasis, and these limitations are not given weight because the method of treatment and compound d
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to use the method disclosed in Jin for treating psoriasis with TYK2 inhibitors and combine it with the method disclosed in Nogueira for treating moderate-to-severe psoriasis with TYK2 inhibitors, because both methods use the same mechanism of action, TYK2 inhibitors, and both treat the same disease, psoriasis. One of ordinary skill would be motivated to treat moderate-to-severe psoriasis with the compound disclosed in Jin to arrive at the claim limitations because it was known in the art to treat moderate-to-severe psoriasis with TYK2 inhibitors.
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 1-7, 9, and 15-19 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/119,264, herein ‘264 and/or in further view of Bafutto (Mauro Bafutto et al., “Evaluation of psoriasis treatment with esomeprazole-a pilot study, Arq. Gastroenterol, Volume 56, Issue 3, Pub. Date: 30 September 2019), Prakash (Amitabh Prakash et al., “Rabeprazole”, Adis New Drug Profile, Volume 55, Pgs. 261-267, Pub. Date: 27 November 2012), Culhane (James Culhane et al., “Targeted Therapy with Tyrosine Kinase Inhibitors”, US Pharmacology, Pub. Date: October 17, 2008), and Nogueira (Miguel Nogueira et al., “JAK Inhibitors for Treatment of Psoriasis: Focus on Selective TYK2 Inhibitors”, Drugs, Volume 80, pgs. 341-353, Pub. Date: 04 February 2020).
Regarding instant claims 1, 5, 7, 9, and 15, claims 1, and 13-15 in copending application ‘264 disclose:
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The crystal form of N-(4-((2-methoxy-3-(1-(methyl-d3)-1H-1,2,4-triazol-3-yl)phenyl) amino)-5-(propanoyl-3,3,3-d3)pyridin-2-yl) cyclopropanecarboxamide disclosed in copending application ‘364, anticipates the compound disclosed in instant claim 1.
Copending applicaton ‘264 does not disclose oral administration of N-(4-((2-methoxy-3-(1-(methyl-d3)-1H-1,2,4-triazol-3-yl)phenyl) amino)-5-(propanoyl-3,3,3-d3)pyridin-2-yl) cyclopropanecarboxamide, once or twice daily 10 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, or 160 mg, or the compound administered in a fasted state.
Jin discloses Cyclopropanecarboxamide, N-[4-[[2-methoxy-3-[1-(methyl-d3)-1H-1,2,4-triazol-3-yl] phenyl] amino]-5-(1-oxopropyl-3,3,3-d3)-2-pyridinyl]- (ACI), herein Compound 1, see below, useful for treating TYK2-mediated disorders (Abstract and Pg. 299). Jin discloses oral administration of pharmaceutical compositions (Pg.146, [00395]).
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Jin discloses before administration of compounds in animal studies, the animals were fasted overnight (Pg. 274, [00757]).
Jin discloses “In some embodiments the disease or disorder is selected from type 1 diabetes, systemic lupus erythematosus, multiple sclerosis, psoriasis, Behcet's disease, POEMS syndrome, Crohn's disease, ulcerative colitis, and inflammatory bowel disease.” (Pg. 147, [00401]).
Jin discloses “For example, in specific embodiments, a compound described herein or a formulation containing the compound is administered for at least 2 weeks, about 1 month to about 5 years.” (Pg. 151, [00422]).
Jin discloses “For a 70 kg patient, dosages of from about 10 mg to about 200 mg of the compound disclosed herein would be more commonly used, depending on a subject’s physiological response.” (Pg. 147, [00396]). Jin also discloses “In some embodiments, the dose of compounds described herein for the described methods is about 1 to about 1000 mg/kg body weight of the subject being treated per day” (Pg. 147, [00397]).
The courts found that, 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) The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.
Regarding Claims 1, 5, 7, 9, and 15, it would have been prima facie obvious to combine the method disclosed in copending application ‘564 for treating a TYK-2 mediated disease, such as psoriasis by administering a crystalline form of compound 1, and combine it with the method disclosed in Jin for treating TYK2 mediated diseases such as psoriasis by administering compound 1, in a fasted state, and with the disclosed dosage range, to arrive at the claimed limitations because copending application ‘564 and Jin teach the same compound administered to treat the same disease, psoriasis, with the same mechanism of action, TYK2 inhibitor. One of ordinary skill would be motivated to optimize the method to arrive at the instant claims, based on the disclosures from copending application ‘264 and Jin.
Regarding instant Claims 2 and 3, copending application ‘364 and Jin does not teach proton pump inhibitors administered for treating a TYK2-mediated disease, such as psoriasis.
Bafutto teaches that proton pump inhibitors (PPIs) have anti-oxidant properties that directly effects neutrophils, monocytes, endothelial, and epithelial cells, that prevent inflammation (Abstract). The study evaluated the treatment of psoriasis with esomeprazole, a proton pump inhibitor, and shows the use of esomeprazole for treating psoriasis resulted in a significant reduction of (Psoriasis Area and Severity Index) PASI score and good clinical results (Abstract).
Regarding instant Claims 2 and 3, it would have been prima facie obvious for one of ordinary skill in the arts, to combine the methods disclosed in copending application ‘364, for treating TYK2 mediated diseases, such as psoriasis with TYK2 inhibitors, with the method disclosed in Bafutto for treating psoriasis with proton pump inhibitor esomeprazole, because both compounds are taught by the prior art to be used to treat psoriasis. Administering proton pump inhibitor esomeprazole with a TYK2 inhibitor to treat the same disease is obvious.
Regarding instant Claim 4, copending application ‘364, and Bafutto do not teach rabeprazole as a proton pump inhibitor administered for treating psoriasis.
Prakash teaches Rabeprazole as a proton pump inhibitor, with 2 to 10-fold greater antisecretory activity than omeprazole in vitro. Prakash also teaches rabeprazole has a similar tolerability profile to omeprazole (Summary).
Regarding instant Claim 4, it would have been prima facie obvious for one of ordinary skill in the arts to substitute the proton pump inhibitor omeprazole disclosed in Bafutto, with the proton pump inhibitor rabeprazole disclosed in Prakash, to arrive at the claimed limitations, because Prakash teaches that rabeprazole has greater antisecretory activity than omeprazole. Antisecretory activity is important because it protects the stomach lining from acid damage and prevents fluid loss during illnesses, one of ordinary skill would be motivated to use rabeprazole over omeprazole for the added patient benefits.
Regarding instant Claim 6, copending application ‘364, does not teach administering food to the patient before administration of the compound.
Culhane teaches Tyrosine Kinase Inhibitors (TKIs) can be administered with or without food because clinical trial data and specific patient toxicities show no consistency between all TKIs (Pg. 12).
It would have been prima facie obvious for one of ordinary skill to take the compound and method of use disclosed in copending application ‘364 for treating TYK-2 mediated diseases, and combine them with the method disclosed in Culhane because both methods disclose uses for Tyrosine Kinase inhibitors. It would be obvious to optimize the treatment plan to include administering the compound with food, because Culhane teaches every TKI has its own recommendation based on clinical trials and specific patient toxicities.
Regarding instant claims 16-18, copending application ‘364, does not teach severe psoriasis as an embodiment, or a quantitative definition of severe psoriasis.
Nogueira teaches PF-06826647 as a selective TYK2 inhibitor being investigated for treating moderate-to-severe psoriasis in a Phase II clinical trial.
Regarding Claims 16-18, The court noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Claims 16-18 recite “significant clinical improvement” after administering the patient the compound to treat moderate to severe psoriasis, and these limitations are not given weight because the method of treatment and compound d
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to use the method disclosed in copending application ‘364 for treating psoriasis with TYK2 inhibitors and combine it with the method disclosed in Nogueira for treating moderate-to-severe psoriasis with TYK2 inhibitors, because all of the methods use the same mechanism of action, TYK2 inhibitors, and treat the same disease, psoriasis. One of ordinary skill would be motivated to treat moderate-to-severe psoriasis with the compound disclosed in copending application ‘364 to arrive at the claim limitations because it was known in the art to treat moderate-to-severe psoriasis with TYK2 inhibitors.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/C.M.R./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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