DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 3/27/2026 is acknowledged. The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election without further specifying traverse of a single method in the reply filed on 3/27/2026 is also acknowledged.
The elected species read upon claims 1-4, 6-11, 13-14 and 16-22. Claims 5, 12 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-11, 13-14 and 16-22 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bissonnette et al (Br J Dermatol 175:902-911, 2016) in view of Kubo et al (Ann Rheum Dis 73:2192-2198, 2014) and Anderson et al (US 2019/0135808; of record).
Claim 1 is drawn to a method for treating a skin condition caused by immune deficiency (more specifically, atopic dermatitis (claim 2)) in a human subject in need thereof, the method comprising:
topically administering (twice a day (claim 6)) to a region of the subject affected by the skin condition (more specifically, to a skin lesion caused by the skin condition (claim 4)), a composition comprising about 0.5% to about 4.0% of a compound having the structure of Compound I:
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wherein the skin condition is treated.
Bissonnette et al teach “[t]opical tafacitinib for atopic dermatitis” (Title). Specifically, Bissonnette et al teach that topical application of “2% tofacitinib ointment... twice daily to all AD areas, except those on hair-bearing scalp” for 4 weeks (Page 903, Column 2) to human subjects having an Eczema Area and Severity Index (EASI) total score ranging from 1.4 to 13.3, body surface area (BSA) ranging from 2.0 to 17.0, and Physician’s Global Assessment (PGA) of mild to moderate (Page 906, Table 1) – which is understood to entail a subject exhibiting skin lesions – resulted in “[s]ignificant improvements in EASI, PGA and BSA... by week 1 and improvements in pruritus... by day 2” (Abstract) and “demonstrated significantly greater efficacy vs. vehicle” (Page 909, Column 1).
As such, the method of treating atopic dermatitis taught by Bissonnette et al differs from the instantly claimed method in that Bissonnette et al teach topical administration of tofacitinib as opposed to Compound I.
Yet, as taught by Kubo et al, “[t]ofacitinib [is] a JAK1/JAK3 inhibitor” (Abstract).
And, as further taught by Anderson et al – disclosing “pyrrolopyridine compounds and compositions and their application as pharmaceuticals for the treatment of disease” (Abstract), in particular, pyrrolopyridine compounds which are inhibitors of “JAK1 and JAK3 kinase activity... for the treatment of JAK1 and/or JAK3-mediated conditions” (Paragraph 0003; see also Paragraph 0111), wherein pharmaceutical compositions include “those suitable for... topical... administration” (Paragraph 0358) wherein “the active ingredient may comprise from 2% w/w to 5% w/w” or “from 0.1% to 1% w/w of the formulation” (Paragraph 0368), and wherein “[i]n certain embodiments, the JAK1 and/or JAK3-mediated disease is chosen from... atopic dermatitis” (Paragraph 0427) – Compound I (Page 32, Example #117) is a potent JAK1 and JAK3 inhibitor, exhibiting a JAK1 and JAK3 inhibition IC50 of < 0.01 µM (Page 125, Table 2).
Accordingly, based further on Kubo et al and Anderson et al, it would have been prima facie obvious to topically administer (twice daily) a composition comprising 2% Compound I in the method of treating atopic dermatitis taught by Bissonnette et al as opposed to tofacitinib. The simple substitution of one known JAK1/JAK3 inhibitor useful in the treatment of atopic dermatitis for another known JAK1/JAK3 inhibitor useful in the treatment of atopic dermatitis is prima facie obvious.
As such, claims 1-2, 4 and 6 are rejected as prima facie obvious.
Claim 3 is drawn to the method of claim 1, wherein said administering reduces an EASI score, BSA measurement, etc. of the subject.
At the outset, as discussed by the court in Hoffer v. Microsoft Corp., 405 F.3d 1326 (Fed. Cir. 2005), a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited” (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373 (Fed. Cir. 2003)). In the instant case, the whereby clause (i.e., reducing an EASI score, BSA measurement, etc.) simply expresses the intended result of a process step positively recited (i.e., topically administering Compound I to a human subject suffering from atopic dermatitis). As such, the wherein clause is not given patentable weight. As noted by the court in Verdegaal Bros., Inc. v. Union Oil Co. of Calif., 814 F.2d 628 (Fed. Cir.), cert. Denied, 484 U.S. 827 (1987), merely discovering and claiming a new benefit of an old process cannot render the process again patentable.
Nevertheless, as discussed above, Bissonnette et al teach that topical application of “2% tofacitinib ointment... twice daily to all AD areas, except those on hair-bearing scalp” for 4 weeks (Page 903, Column 2) resulted in “[s]ignificant improvements in EASI, PGA and BSA... by week 1 and improvements in pruritus... by day 2” (Abstract).
Accordingly, even if the wherein clause were afforded patentable weight, it is evident that the prima facie obvious method comprising topically administering Compound I would necessarily reduce an EASI score and/or BSA measurement of the subject.
For either reason, claim 3 is also rejected as prima facie obvious.
Claim 7 is drawn to the method of claim 1, wherein a composition comprising 2% w/w Compound I is administered twice daily.
As discussed above, regarding the rejection of claims 1-2, 4 and 6, it would have been prima facie obvious to topically administer (twice daily) a composition comprising 2% Compound I for the treatment of atopic dermatitis, with a reasonable expectation of success.
Since claim 7 does not introduce any limitations not already addressed in the rejection of claims 1-2, 4 and 6 above, claim 7 is also rejected as prima facie obvious.
Claim 8 is drawn to the method of claim 1 (comprising “topically administering to a region of the subject affected by the skin condition), wherein about 0.25 mL to about 8 mL of the composition comprising 2% w/w Compound I is administered topically to said subject.
As taught by Bissonnette et al, the “2% w/w tofacitinib ointment... was applied twice daily to all AD areas... at a target rate of approximately 3 mg cm-2” (Page 903, Column 2).
Based on an approximate total body surface area of an average adult human of about 17,300 cm2 wherein “mean BSA was 6.8” (Page 905, Column 1), it is calculated that approximately 1,176 cm2 of affected skin was treated according to the method of Bissonnette et al, which would entail application of about 3,528 mg of tofacitinib (at 3 mg/cm2) or about 176 mL of ointment comprising 2% tofacitinib. And since about 176 mL of ointment comprising 2% tofacitinib was applied “to all AD areas” according to the method of Bissonnette et al, it is necessarily the case that about 0.25 mL to about 8 mL was applied to some portion of that area (i.e., to “a region of the subject affected by the skin condition”) as instantly claimed.
As such, claim 8 is also rejected as prima facie obvious.
Claims 9-10 are drawn to the method of claim 1, wherein the composition is a solution.
As discussed above, Bissonnette et al teach topical application of “2% tofacitinib ointment” (Page 903, Column 2).
Yet, as taught by Anderson et al, pharmaceutical compositions “suitable for topical administration include liquid or semi-liquid preparations suitable for penetration through the skin to the site of inflammation such as a solution... [or] ointment” (Paragraph 0368).
Accordingly, based further on Anderson et al, it would have been prima facie obvious to formulate the topical composition comprising 2% Compound I for treating atopic dermatitis as a solution. The simple substitution of one known topical formulation for another is prima facie obvious.
As such, claims 9-10 are also rejected as prima facie obvious.
Claim 11 is drawn to the method of claim 1, wherein said administering comprises topical application of a solution comprising 2% w/w Compound I twice daily.
As discussed above, regarding the rejection of claims 1-2, 4, 6 and 9-10, it would have been prima facie obvious to topically administer (twice daily) a composition in the form of a solution comprising 2% Compound I for the treatment of atopic dermatitis, with a reasonable expectation of success.
Since claim 11 does not introduce any limitations not already addressed in the rejection of claims 1-2, 4, 6 and 9-10 above, claim 11 is also rejected as prima facie obvious.
Claim 13 is drawn to a method for reducing severity and extent of skin lesions caused by an immune deficiency in a human subject in need thereof (more specifically, a human subject diagnosed with atopic dermatitis (claim 14)), the method comprising:
topically administering (twice a day (claim 16)) to a human subject having the immune deficiency a composition comprising about 0.5% to about 4.0% of a compound having the structure of Compound I (more specifically, a solution comprising 2% w/w Compound I (claims 18-21) wherein about 0.25 mL to about 8 mL of the composition is administered to said subject (claim 22)):
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wherein the severity and extent of the skin lesions is reduced (more specifically, wherein an EASI score, BSA measurement, etc. of the subject is reduced (claim 17)).
As discussed above, Bissonnette et al in view of Kubo et al and Anderson et al teach a method of treating atopic dermatitis, comprising topically administering, twice daily, to a region of a subject affected by the skin condition (including a skin lesion caused by the skin condition) a composition in the form of a solution comprising 2% w/w of Compound I, wherein about 0.25 mL to about 8 mL of the composition is administered to said subject, wherein said administering reduces an EASI score and/or BSA measurement of the subject.
At the outset, while Bissonnette et al do not specifically teach reducing the severity and extent of skin lesions, as instantly claimed, Applicant is reminded that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Nevertheless, it is evident that the subjects treated according to Bissonnette et al, having a baseline Eczema Area and Severity Index (EASI) total score ranging from 1.4 to 13.3, body surface area (BSA) ranging from 2.0 to 17.0, and Physician’s Global Assessment (PGA) of mild to moderate (Page 906, Table 1; see also Page 905, Column 1: “[o]verall mean EASI total score was 5.6, mean BSA was 6.8 and mean ISI score was 6.0”), exhibited skin lesions caused by atopic dermatitis. And, considering that, following treatment, “the proportion of patients with a PGA of clear or almost clear... was 73%” (Page 905, Column 2) and “[s]ignificant improvements in EASI, PGA and BSA were observed” (Abstract), it is further evident that the subjects treated according to Bissonnette et al exhibited a reduction in the severity and extent of skin lesions.
For either reason, claims 13-14 and 16-22 are also rejected as prima facie obvious.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2 and 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-20 of U.S. Patent No. 10,800,775 in view of Anderson et al (US 2019/0135808; of record).
Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 17 of the ‘775 patent is drawn to a method of treating a JAK1- and/or JAK3-mediated disease in a subject in need thereof, comprising selecting a subject having a JAK1- and/or JAK3-mediated disease selected from atopic dermatitis and administering, topically, to the selected subject, a therapeutically effective amount of a compound of claim 1.
It would have been prima facie obvious to carry out the method of the ‘775 patent utilizing a composition comprising 2% w/w Compound I based on Anderson et al, which teach that Compound I (Page 32, Example #117) is a potent JAK1 and JAK3 inhibitor, exhibiting a JAK1 and JAK3 inhibition IC50 of < 0.01 µM (Page 125, Table 2), which can be administered in the form of a pharmaceutical composition including those “suitable for topical administration include[ing] liquid or semi-liquid preparations suitable for penetration through the skin to the site of inflammation such as a solution... [or] ointment” (Paragraph 0368), wherein “the active ingredient may comprise from 2% w/w to 5% w/w” or “from 0.1% to 1% w/w of the formulation” (Paragraph 0368), for “the treatment of JAK1 and/or JAK3-mediated conditions” (Paragraph 0003; see also Paragraph 0111), wherein “[i]n certain embodiments, the JAK1 and/or JAK3-mediated disease is chosen from... atopic dermatitis” (Paragraph 0427).
Claims 1-2 and 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-16 and 18-21 of U.S. Patent No. 10,981,906 in view of Anderson et al (US 2019/0135808; of record).
Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 13 of the ‘906 patent is drawn to a method of treating a JAK1- and/or JAK3-mediated disease in a subject in need thereof, comprising administering to the selected subject, a therapeutically effective amount of a compound of claim 1, wherein, as recited by claim 15, the JAK1- and/or JAK3- medicated disease is atopic dermatitis.
It would have been prima facie obvious to carry out the method of the ‘775 patent by topically administering a composition comprising 2% w/w Compound I based on Anderson et al, which teach that Compound I (Page 32, Example #117) is a potent JAK1 and JAK3 inhibitor, exhibiting a JAK1 and JAK3 inhibition IC50 of < 0.01 µM (Page 125, Table 2), which can be administered in the form of a pharmaceutical composition including those “suitable for topical administration include[ing] liquid or semi-liquid preparations suitable for penetration through the skin to the site of inflammation such as a solution... [or] ointment” (Paragraph 0368), wherein “the active ingredient may comprise from 2% w/w to 5% w/w” or “from 0.1% to 1% w/w of the formulation” (Paragraph 0368), for “the treatment of JAK1 and/or JAK3-mediated conditions” (Paragraph 0003; see also Paragraph 0111), wherein “[i]n certain embodiments, the JAK1 and/or JAK3-mediated disease is chosen from... atopic dermatitis” (Paragraph 0427).
Claims 1-2 and 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,281,111 in view of Anderson et al (US 2019/0135808; of record).
Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘906 patent is drawn to a method of treating a JAK1- and/or JAK3-mediated disease in a subject in need thereof, comprising administering to the selected subject, a therapeutically effective amount of a compound of Formula (I), wherein, as recited by claim 2, the JAK1- and/or JAK3- medicated disease is atopic dermatitis, and wherein, as recited by claim 6, the compound is instantly claimed Compound I
It would have been prima facie obvious to carry out the method of the ‘775 patent by topically administering a composition comprising 2% w/w Compound I based on Anderson et al, which teach that Compound I (Page 32, Example #117) is a potent JAK1 and JAK3 inhibitor, exhibiting a JAK1 and JAK3 inhibition IC50 of < 0.01 µM (Page 125, Table 2), which can be administered in the form of a pharmaceutical composition including those “suitable for topical administration include[ing] liquid or semi-liquid preparations suitable for penetration through the skin to the site of inflammation such as a solution... [or] ointment” (Paragraph 0368), wherein “the active ingredient may comprise from 2% w/w to 5% w/w” or “from 0.1% to 1% w/w of the formulation” (Paragraph 0368), for “the treatment of JAK1 and/or JAK3-mediated conditions” (Paragraph 0003; see also Paragraph 0111), wherein “[i]n certain embodiments, the JAK1 and/or JAK3-mediated disease is chosen from... atopic dermatitis” (Paragraph 0427).
Claims 1-2 and 9-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-66 of copending Application No. 19/086,512 in view of Anderson et al (US 2019/0135808; of record).
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘512 claims are drawn to a method of treating a JAK1- and/or JAK3-mediated disease in a subject in need thereof, comprising administering a therapeutically effective amount of instantly claimed Compound I (claim 43), wherein the JAK1- and/or JAK3-mediated disease is atopic dermatitis (claim 44).
It would have been prima facie obvious to carry out the method of the ‘512 application by topically administering a solution comprising 2% w/w Compound I based on Anderson et al, which teach that Compound I (Page 32, Example #117) is a potent JAK1 and JAK3 inhibitor, exhibiting a JAK1 and JAK3 inhibition IC50 of < 0.01 µM (Page 125, Table 2), which can be administered in the form of a pharmaceutical composition including those “suitable for topical administration include[ing] liquid or semi-liquid preparations suitable for penetration through the skin to the site of inflammation such as a solution... [or] ointment” (Paragraph 0368), wherein “the active ingredient may comprise from 2% w/w to 5% w/w” or “from 0.1% to 1% w/w of the formulation” (Paragraph 0368), for “the treatment of JAK1 and/or JAK3-mediated conditions” (Paragraph 0003; see also Paragraph 0111), wherein “[i]n certain embodiments, the JAK1 and/or JAK3-mediated disease is chosen from... atopic dermatitis” (Paragraph 0427).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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