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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/6/23 has been entered.
Status of Claims
Applicant’s amendment filed December 15, 2025 is acknowledged. Claims 2, 4, and 8 are original. Claims 1, 6, 32, 34, 36, 38 and 45 have been previously presented. Claim 23 has been amended. Claims 3, 10, 11 and 33 have been withdrawn. Claim 5, 7, 9, 12-22, 24-31, 35, 37 and 39-44 have been cancelled. Claims 1-4, 6, 8, 10-11, 23, 32-34, 36, 38, and 45 are pending. Claims 1-2, 4, 6, 8, 23, 32, 34, 36, 38 and 45 are under examination.
Rejection Withdrawn
The rejection of claim 40 under 112(b), page 3 of the Final Office action mailed August 13, 2025.
Rejections Maintained
Claim Rejections - 35 USC § 112
The rejection of claims 1-2, 4, 6, 8, 23, 32, 34, 36, 38 and 45 under 112(a), Final Office action, pages 3-4 mailed August 13, 2025 is maintained.
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description/New Matter
The claims are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The newly amended independent claims recite the limitation of “up to week 48”. However, applicant has not pointed out, nor can the examiner locate, the basis in the specification for such a limitation.
This is a new matter rejection.
Applicant’s Arguments
Applicant disagrees with the Office’s assertion that the claims do not comply with the written description requirement. Applicant notes that the limitation “up to 48 week” is supported by claims 14 as originally filed. Applicant also notes in Figures 2 and 5 of the specification, ACR20/50/70 response of PASI 75/90/100 were shown to be stabilized by week 48 after administration every 12 weeks of either 100 mg or 200 mg of the anti-IL23p19 antibody hum13B8-b to patients with psoriatic arthritis. Applicant contends, therefore that the limitation “up to week 48” is supported by the specification, and respectfully requests reconsideration and withdrawal of this ground of rejection.
Examiner’s Response to Applicant’s Arguments
Applicant's arguments filed December 15, 2025 have been fully considered but they are not persuasive. While Applicant does disclose original claim 14 which recites “the method according to claim 1, wherein the treatment comprises administration of the subsequent dose at every 12 weeks at least up to 48 weeks” instant claim 1 recites “a method of treating psoriatic arthritis comprising administering an anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein the patient is subcutaneously administered a first dose of the antibody on week 0 and a subsequent dose at every 12 weeks thereafter up to week 48 and wherein the antibody huml3B8-b comprises:(i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1; and(ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2”.
It should be noted that “wherein the treatment comprises administration of the subsequent dose at every 12 weeks at least up to 48 weeks”, refers to the subsequent dose which could be read as one or more doses following an earlier dose. The limitation could be interpreted as requiring dosing every 12 weeks through week 48 and possibly beyond or it could be interpreted as a dose administered at the 12-week time point, with treatment extending to week 48. Instant claim 1, recites “a first dose of the antibody on week 0 and a subsequent dose at every 12 weeks thereafter up to week 48” defines the reference point from which the 12-week intervals are measured, specifies a schedule of doses at weeks 12, 24, 36 and 48 and up to 48 more naturally suggests that the claimed schedule extends no later than week 48. Thus, the treatment of instant claim 1 is limited to 48 weeks. Original claim 14 reciting “subsequent dose at every 12 weeks at least up to 48 weeks “ indicating that the dosing frequency may extend beyond 48 weeks. Regarding Figures 2 and 5, these figures indicate that the dose frequency is up to 52 weeks and not restricted to 48 weeks as indicated by instant claim 1. Therefore, the scope of claim 1 has changed and the new matter rejection is maintained.
The rejection of claims 1-2, 4, 6, 8, 23, 32, 34, 36, 38 and 45 under 103(a), Final Office action, pages 4-7 mailed August 13, 2025 is maintained.
Claim Rejections - 35 USC § 103
Rejections Over Prior Art:
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 of this title, 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.
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 of this title, 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 claims are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT03552276 (v1, 6/8/2018), in view of Clinical Trial NCT02980692 (v4, 2/16/2018), and as evidenced by Kashi et al. (US2015/ 0329632A1, 11/19/2015), and Merck Sharp & Dohme Corp. (HIGHLIGHTS OF PRESCRIBING INFORMATION for ILUMYA™ (tildrakizumab-asmn) injection, 3/2018).
Claim 1 is drawn to a method of treating psoriatic arthritis comprising administering an anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein the patient is subcutaneously administered a first dose of the antibody on week 0 and a subsequent dose at every 12 weeks thereafter up to week 48; and wherein the antibody huml3B8-b comprises:(i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1; and(ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.
Claim 2 is drawn to the method according to claim 1, wherein the first dose and the subsequent dose are the same.
Claim 4 is drawn to the method according to claim 1, wherein the first dose is 100 mg or 200 mg.
Claim 6 is drawn to the method according to claim 1, wherein the subsequent dose is 100 mg or 200 mg.
Claim 8 is drawn to the method according to claim 2, wherein the first dose and the subsequent dose are 100 mg, or the first dose and the subsequent dose are 200 mg.
Claims 23 is drawn to a method of determining the efficacy of an anti-IL- 23p19 antibody for the treatment of psoriatic arthritis comprising administering an anti- IL-23p19 antibody hum13B8-b to a patient and measuring the patient's Psoriasis Area and Severity Index (PASI) and American College of Rheumatology (ACR) 20/50/70 response, wherein the patient is subcutaneously administered a first dose of the antibody on week 0 and a subsequent dose at every 12 weeks after the first dose up to week 48; and wherein the antibody hum13B8-b comprises:(i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1; and(ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; wherein:(a) an ACR20 response value of at least 40% at week 24 indicates the efficacy of the antibody;(b) an ACR50 response value of at least 20% at week 24 indicates the efficacy of the antibody; or (c) an ACR70 response value of at least 10% at week 24 indicates the efficacy of the antibody, and wherein:(1) at least a 75% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody; (2) at least 90% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody.
Claim 32 is drawn to the method according to claim 23, wherein the first dose and the subsequent dose are same.
Claim 34 is drawn to the method according to claim 23, wherein the first dose is 100 mg or 200 mg.
Claim 36 is drawn to the method according to claim 23, wherein the subsequent dose is 100 mg or 200 mg.
Claim 38 is drawn to the method according to claim 23, wherein the first dose and the subsequent dose are 100 mg, or the first dose and the subsequent dose are 200 mg.
Claim 45 is drawn to the method according to claim 23, wherein the patient is subcutaneously administered an additional dose on week 4.
Clinical Trial NCT03552276 discloses a long term study to demonstrate the safety and efficacy of tildrakizumab in subjects with psoriatic arthritis (PsA) and ankylosing spondylitis or non-radiographic axial spondyloarthritis who have previously completed studies with tildrakizumab, wherein the regimens include that the subjects with PsA received tildrakizumab 200 mg q12 weeks, or 100 mg q12 weeks at weeks 8, 20, 32, 44, 56, and all subsequent 12-weekly time points to week 200 (one or two of 1-mL injections of 100 mg/mL) (8th page, under “Arms and Interventions” – “Arms”). Note, according to the specification, tildrakizumab comprises a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1 and a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2 (page 6, [0026]). Additionally, NCT03552276 teaches the outcome measures of the study, which include proportion of subjects achieving a 20% reduction from Baseline in American College of Rheumatology response criteria (ACR20), and improvement from Baseline in both tender joints and swollen joints will be assessed (9th page, under “Outcome Measures”). As evidenced by Kashi, the reference teaches anti-IL-23p19 antibody hum13B8-b comprising the heavy chain of SEQ ID NO: 1 and the light chain of SEQ ID NO: 2, which are 100% identical to the present SEQ ID NO: 2 and 1, respectively. Further, as evidenced by the Merck reference, ILUMY (tildrakizumab) injection is for subcutaneous use (page 1, 1st column). Clinical Trial NCT02980692 teaches a phase 2b clinical study to demonstrate the safety and efficacy of tildrakizumab in subjects with active psoriatic arthritis, wherein the outcome measures were conducted at week 24 and 52 (6th page, under “Outcome Measures”).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat psoriatic arthritis by subcutaneous administration of tildrakizumab using a regimen of 100 mg q12w or 200 mg q12w, and measure the outcomes such as ARC20 at 24 and/or 52 weeks, following the teachings of NCT03552276 and NCT02980692. The person of ordinary skill in the art would have been motivated to do so for disease treatment, and reasonably would have expected success because prior art has established that tildrakizumab can be used for treating patients with PsA. Note, with respect to the limitations recited in claim 23 (“wherein the treatment further results in ...), they represent the treatment results or efficacy, which would be the necessary properties of the antibody treatment, as such are out of anyone’s control once the antibody is administered; and do not in any way alter the nature of the claimed method. Therefore, these limitations do not carry patentable weight. With respect to the limitation “an ACR20 response value of at least 40% at week 24 indicates the efficacy of the antibody; (b) an ACR50 response value of at least 20% at week 24 indicates the efficacy of the antibody; or (c) an ACR70 response value of at least 10% at week 24 indicates the efficacy of the antibody, and wherein:(1) at least a 75% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody; (2) at least 90% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody such would be obvious as the significant improvement in disease scores during the treatment would necessarily indicate the effectiveness of the treatment.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Applicant’s Arguments
In response to the argument presented in Applicant's response to the Office Action issued on March 5, 2025 that one of skill in the art would not have been motivated to use the shorter duration treatment recited in the instant claims because the prior art did not demonstrate that shorter duration treatment is effective, the Action states that the claims recite ACR or PASI values indicating the efficacy, not efficacy itself, and that efficacy adds no patentable weight. The Action also states that efficacy represents an inherent property because once the antibody is administered, the result would be out of anyone's control, and further states that a reasonable expectation of success does not require an absolute predictivity, such as efficacy. Applicant respectfully disagrees with the Action's assertion that the claims are unpatentable over the '276 trial in view of the '692 trial, as evidenced by Kashi et al. and Merck. First, Applicant notes that although chronic disease may not be cured, its symptoms can be managed effectively. Applicant also notes that every measurement of the patient's response as shown in Figures 2 and 4-6 of the instant application indicates the effectiveness of the regimen by week 48 as recited in the instant claims. Indeed, Applicant contends that the instant application demonstrates a surprising and unexpected result in that a chronic disease such as psoriatic arthritis can be managed in a shorter time (i.e., 48 weeks) than the time suggested in the '276 trial (i.e., 200 weeks). Second, even if the Action considers efficacy to be an inherent property and does not require absolute predictivity, Applicant contends that one of skill in the art, would not have reasonably expected the shorter duration treatment recited in the claims to be effective. The Action has not indicated how a skilled artisan would have been motivated to treat patients for 48 weeks, without any suggestion in the art that the shorter duration treatment would have been effective. Applicant therefore contends that a skilled artisan would not have been motivated to try a duration of treatment of up to 48 weeks and would not have had a reasonable expectation of success to employ such a duration of treatment, given that none of the cited references discloses any efficacy data for a 48-week treatment. For the reasons discussed above, Applicant respectfully requests reconsideration and withdrawal of this ground of rejection.
Examiner’s Response to Applicant’s Arguments
Applicant arguments are not persuasive for the reasons of record, and the following: first, 1 and 23 have been amended to recite “up to 48 weeks” (not “up to 52 weeks”), which also is not supported by the specification. Additionally, the instant rejection is an obviousness type of rejection. MPEP makes it clear: “Prior art is not limited just to the references being applied, but includes the understanding of one of ordinary skill in the art. The prior art reference (or references when combined) need not teach or suggest all the claim limitations, however, Office personnel must explain why the difference(s) between the prior art and the claimed invention would have been obvious to one of ordinary skill in the art. The ‘mere existence of differences between the prior art and an invention does not establish the invention’s nonobviousness.’ Dann v. Johnston, 425 U.S. 219, 230, 189 USPQ 257, 261 (1976). … … The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts. See 35 U.S.C. 103(a). Factors other than the disclosures of the cited prior art may provide a basis for concluding that it would have been obvious to one of ordinary skill in the art to bridge the gap” (MPEP 2141, III.). In the instant case, given the fact that psoriatic arthritis is a chronic inflammatory and autoimmune disease, it is more likely than not that the patient would need the treatment beyond 48 weeks (not to mention that even the specification does not support “up to 48 weeks” which requires that the treatment frequency ends at 48 weeks and not beyond). Applicant further argues that Figures 2 and Figures 4-6 of the instant application demonstrate that the anti-IL-23p19 antibody hum13B8-b (i.e., tildrakizumab) was significantly effective as compared to placebo treatment, with a therapeutic effect reaching a maximum and then plateauing by week 52, which is less than half the duration of 200 weeks disclosed in the '276 trial; that one of ordinary skill in the art would not reasonably expect these results based on the general technical knowledge in the art; that none of '276 trial, '692 trial, Kashi, or Merck discloses any experimental data suggesting that the dosage and regimen recited in the claims as amended would have been effective in treating psoriasis arthritis; that a skilled artisan, in view of '276 trial, '692 trial, Kashi, or Merck, would not have been motivated to use the shorter regimen of 52 weeks as claimed, and would not have reasonably expected such a regimen to yield the efficacy as shown in the instant application; and that regarding claim 23, the instant application indicates that ACR20/50/70 response refers to the percentage of subjects with at least a 20%/50%/70% improvement, and does not refer to the percentage of improvement, therefore, a percentage of over 20% for ACR20 is not obvious for the reasons that the Action has asserted. This argument is not persuasive for the reasons of record, and the following: first, efficacy is not a requirement for prior art enablement (see MPEP 2121 III.). Additionally, the present claims merely recite certain ACR or PASI values indicating the efficacy, not the efficacy itself (again, not required, and adding no patentable weight). Further, even if efficacy were recited in the claims, efficacy or treatment result represents inherent property because once the antibody is administered, the result would be out of anyone’s control. Furthermore, a reasonable expectation of success does not require an absolute predictivity, such as efficacy in the instant case. Obviousness does not require absolute predictability. It should be noted that the ‘276 trial teaches subjects with psoriatic arthritis (PsA) and ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA) who met the inclusion criteria of the parent studies an completed the parent study treatment period (e.g. up to Week 48 for the parent Phase 2 studies, with the return for the end of treatment (EoT) assessment at Week 52).
New Rejections Necessitated by Applicant’s Amendments
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Enablement
Claims 1-2, 4, 6, 8, 23, 32, 34, 36, 38 and 45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
It is noted that MPEP 2164.03 teaches that “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability of the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The amount of guidance or direction refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as how to make and use the invention in order to be enabling.”
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (A)). The factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue include, but are not limited to (In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)):
1) nature of the invention;
2) the breadth of the claims;
3) the state of the prior art;
4) the level of one of ordinary skill;
5) the level of predictability in the art;
6) the amount of direction or guidance provided by the inventor;
7) the existence of working examples; and
8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
(1) The nature of the invention and (2) The breadth of the claims
The claims are drawn to a method of treating psoriatic arthritis comprising administering an anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein the patient is subcutaneously administered a first dose of the antibody on week 0 and a subsequent dose at every 12 weeks thereafter up to week 48; and wherein the antibody huml3B8-b comprises:(i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1; and(ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2 and a method of determining the efficacy of an anti-IL- 23p19 antibody for the treatment of psoriatic arthritis comprising administering an anti- IL-23p19 antibody hum13B8-b to a patient and measuring the patient's Psoriasis Area and Severity Index (PASI) and American College of Rheumatology (ACR) 20/50/70 response, wherein the patient is subcutaneously administered a first dose of the antibody on week 0 and a subsequent dose at every 12 weeks after the first dose up to week 48; and wherein the antibody hum13B8-b comprises:(i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1; and(ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; wherein:(a) an ACR20 response value of at least 40% at week 24 indicates the efficacy of the antibody;(b) an ACR50 response value of at least 20% at week 24 indicates the efficacy of the antibody; or (c) an ACR70 response value of at least 10% at week 24 indicates the efficacy of the antibody, and wherein:(1) at least a 75% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody; (2) at least 90% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody.
The claims encompass a method of treating psoriatic arthritis and method of determining efficacy comprising administering an anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, with a dose frequency that ends at week 48.
(3) The state of the prior art and (5) The level of predictability of the art
Regarding treating psoriatic arthritis, Queiro et al (Expert Review of Clinical Pharmacology, Volume 18, 2025, Issue 10) teach over the past two decades, psoriatic arthritis (PsA) management has undergone a profound transformation, driven by advances in our understanding of its immunopathogenesis and the expansion of therapeutic options. The introduction of biologic (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs) has substantially improved disease control for many patients, reducing inflammation, preventing structural damage, and enhancing quality of life. Landmark trials of TNF inhibitors, IL-12/23, IL-17, and JAK inhibitors have demonstrated that tight control strategies can achieve minimal disease activity or remission in a significant proportion of patients. However, real-world experience has revealed that a notable subset of patients do not respond adequately to these agents or loses response over time (see the Introduction). FitzGerald et al (Best Practice & Research Clinical Rheumatology 32 (2018), pages 440-452) teach that psoriatic arthritis (PsA) is a heterogeneous disease characterized by skin and nail psoriasis together with widespread musculoskeletal inflammation (see the Introduction). FitzGerald et al teach that with the increasing treatment options available, we need a better way of deciding which treatment should be considered for which patient (see the Abstract). FitzGerald et al teach for the patient and the treating physician trying to select the best treatment for the patient's particular disease phenotype, we need to much better understand the molecular pathways associated with disease expression and how these might be influenced by targeted therapy. There are 6 classes of biologic (TNFi, IL-17i, IL12/23, and IL23i) or targeted synthetic (JAKi, PDE4i) therapies currently licensed or likely to be approved shortly, and knowing their specific effects on molecular pathways involved in disease expression should be a key focus of study. Other challenges include the lack of head-to-head trials and the absence of agreement on outcome measures in clinical trials for features such as dactylitis, enthesitis, or axial involvement. Better understanding of disease pathogenesis will assist treatment selection and likely add further to the list of possible targets for therapy (See page 443). FitzGerald et al further teach that Despite this considerable progress, there remains a group of treatment-resistant patients, and many of them go through a lengthy period of “trial and error” where they cycle through several treatments before eventually but not always landing on a treatment that works. There has to be a better way, and it is hoped that careful evaluation of patients at baseline, including clinical, genetic, and proteomic profiling, will identify which patients are likely to respond to which treatment. Achieving this goal would ensure that more patients will reach more stringent treatment targets such as minimal disease activity (MDA) or remission (see page 450). Thus, the state of the art has indicated there are a number of challenges that still exist with regard to psoriatic arthritis treatment.
The state of the art discloses a number of literature references that disclose the administration of tildrakizumab to treat psoriatic arthritis in which the dosing frequency of this studies is 52 weeks. See Papp et al, Clinical Trials, British Journal of Dermatology, “Tildrakizumab (MK-3222), an anti-interleukin -23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial”, (2015), pages 930-939), Mease et al “Efficacy and safety of tildrakizumab in patients with active psoriatic arthritis: results of a randomised, double- blind, placebo- controlled, multiple- dose, 52- week phase IIb study”, Ann Rheum Dis 2021;80:1147-1157, and Campione et al, “A Real-Life Study on the Use of Tildrakizumab in Psoriatic Patients”, Pharmaceuticals (Basel), 2023 Mar 31:1(4):526 to name a few.
6) the amount of direction or guidance provided by the inventor; 7) the existence of working examples:
The instant specification the disclosure relates to a method of treating psoriatic arthritis wherein the treatment results in improvement from the baseline value of both tender joint count and swollen joint count. In some embodiments, the disclosure relates to a method of determining the efficacy of an anti-IL-23p19 antibody for the treatment of psoriatic arthritis [paragraph 0001]. The specification teaches a method of determining the efficacy of an anti-IL-23p19 antibody for the treatment of psoriatic arthritis comprising administering an anti-IL-23p19 antibody hum13B8-b to a patient, wherein the patient is subcutaneously administered a first dose of the antibody on week 0 and a subsequent dose at every 12 weeks after the first dose; and wherein the antibody hum13B8-b comprises: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2, and wherein anACR20 response value of at least about40% at week 24 or week 52 indicates the efficacy of the antibody [paragraph 0008]. The specification teaches that in some embodiments, an ACR20 response value of at least about 50% at week 24 or week 52 indicates the efficacy of the antibody. In some embodiments, an ACR20 response value of at least about 60% at week 24 or week 52 indicates the efficacy of the antibody[ paragraph 0052]. In some embodiments, an ACR50 response value of at least about 30% at week 24 or week 52 indicates the efficacy of the antibody [paragraph 0053]. The specification teaches “…wherein at least a 75% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody. In some embodiments, at least 90% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody”. In some embodiments, a 100% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody [paragraph 0055].
It is unclear from the specification as to how one would be able to perform the claim limitation “wherein at least a 75% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody and at least 90% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody” and recited in claim 23, if the claim 23 also recites that the administration of the anti-IL-23p 19 antibody ends at week 48? There is no guidance in the specification in which one of skill in the art could make a determination of efficacy or treat psoriatic arthritis, if the data will not be collected (up to 52 weeks) based on claim limitations restricting the claim method to 48 weeks.
In view of all of the above, the specification does not enable the claimed invention.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 1-2, 4, 6, 8, 23, 32, 34, 36, 38 and 45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicants were in possession of the claimed genus.
The instant claims are drawn to a method of treating psoriatic arthritis comprising administering an anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein the patient is subcutaneously administered a first dose of the antibody on week 0 and a subsequent dose at every 12 weeks thereafter up to week 48; and wherein the antibody huml3B8-b comprises:(i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1; and(ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2 and a method of determining the efficacy of an anti-IL- 23p19 antibody for the treatment of psoriatic arthritis comprising administering an anti- IL-23p19 antibody hum13B8-b to a patient and measuring the patient's Psoriasis Area and Severity Index (PASI) and American College of Rheumatology (ACR) 20/50/70 response, wherein the patient is subcutaneously administered a first dose of the antibody on week 0 and a subsequent dose at every 12 weeks after the first dose up to week 48; and wherein the antibody hum13B8-b comprises:(i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1; and(ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; wherein:(a) an ACR20 response value of at least 40% at week 24 indicates the efficacy of the antibody;(b) an ACR50 response value of at least 20% at week 24 indicates the efficacy of the antibody; or (c) an ACR70 response value of at least 10% at week 24 indicates the efficacy of the antibody, and wherein:(1) at least a 75% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody; (2) at least 90% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody. The claims encompass a method of treating psoriatic arthritis comprising administering an anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein the patient is subcutaneously administered a first dose of the antibody on week 0 and a subsequent dose at every 12 weeks thereafter up to week 48.
The specification discloses in some embodiments provided herein is a method of determining the efficacy of an anti-IL-23p19 antibody for the treatment of psoriatic arthritis comprising administering an anti-IL-23p19 antibody hum13B8-b to a patient, wherein the patient is subcutaneously administered a first dose of the antibody on week 0 and a subsequent dose at every 12 weeks thereafter; and wherein the antibody hum13B8-b comprises: (i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1; and (ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and wherein a statistically significant improvement in disease activity as determined by the minimal disease activity (MDA) criteria at week 52 indicates the efficacy of the antibody [paragraph 0013].The specification at paragraph [0057] discloses wherein a statistically significant improvement in disease activity as determined by the minimal disease activity (MDA) criteria at week 52 indicates the efficacy of the antibody. Example 1 of the instant specification discloses A randomized, double-blind, placebo-controlled, multiple-dose, Phase 2b study was conducted to evaluate the efficacy of four SC groups of tildrakizumab administered by subcutaneous injection in subjects with active PsA (NCT02980692). Subjects with active PsA were randomized 1:1:1:1:1 to receive 200 milligram (mg) tildrakizumab administered by subcutaneous (SC) injection every (q) 4 weeks up until Week 52, 200 mg tildrakizumab administered SC q12 weeks up until Week 52, 100 mg tildrakizumab administered SC q12 weeks up until Week 52, 20 mg tildrakizumab administered SC at weeks 0 and 12, then tildrakizumab 200 mg at Weeks 24 and q12 weeks thereafter up until Week 52, or placebo administered SC at Weeks0, 4, 8, 12, 16, 20, and 24, and then tildrakizumab 200 mg q12 weeks thereafter up until Week 52. All subjects received injections q4 weeks; subjects randomized to the 12-weekly active treatment groups received placebo injections at Weeks 4, 8, 16, 20, 28, 32, 40, and 44.
The specification describes a method of treating psoriatic arthritis and a method of determining the efficacy of an anti-IL- 23p19 antibody for the treatment of psoriatic arthritis that has a dosing frequency that last 52 weeks. The specification does not disclose or contemplate a method of treating psoriatic arthritis or a method of determining the efficacy of an anti-IL- 23p19 antibody for the treatment of psoriatic arthritis that has a dosing frequency that ends at week 48.
Therefore, the specification provides insufficient written description to support the genus encompassed by the claim. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that
"applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2datl966.
The state of the art discloses a number of literature references that disclose the administration of tildrakizumab to treat psoriatic arthritis in which the dosing frequency of this studies is 52 weeks. See Papp et al, Clinical Trials, British Journal of Dermatology, , “Tildrakizumab (MK-3222), an anti-interleukin -23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial”, (2015), pages 930-939), Mease et al “Efficacy and safety of tildrakizumab in patients with active psoriatic arthritis: results of a randomised, double- blind, placebo- controlled, multiple- dose, 52- week phase IIb study”, Ann Rheum Dis 2021;80:1147-1157, and Campione et al, “A Real-Life Study on the Use of Tildrakizumab in Psoriatic Patients”, Pharmaceuticals (Basel), 2023 Mar 31:1(4):526 to name a few.
Regarding the unpredictability of treating psoriatic arthritis, Queiro et al (Expert Review of Clinical Pharmacology, Volume 18, 2025, Issue 10) teach over the past two decades, psoriatic arthritis (PsA) management has undergone a profound transformation, driven by advances in our understanding of its immunopathogenesis and the expansion of therapeutic options. The introduction of biologic (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs) has substantially improved disease control for many patients, reducing inflammation, preventing structural damage, and enhancing quality of life. Landmark trials of TNF inhibitors, IL-12/23, IL-17, and JAK inhibitors have demonstrated that tight control strategies can achieve minimal disease activity or remission in a significant proportion of patients. However, real-world experience has revealed that a notable subset of patients do not respond adequately to these agents or loses response over time (see the Introduction). FitzGerald et al (Best Practice & Research Clinical Rheumatology 32 (2018), pages 440-452) teach that psoriatic arthritis (PsA) is a heterogeneous disease characterized by skin and nail psoriasis together with widespread musculoskeletal inflammation (see the Introduction). FitzGerald et al teach that with the increasing treatment options available, we need a better way of deciding which treatment should be considered for which patient (see the Abstract). FitzGerald et al teach for the patient and the treating physician trying to select the best treatment for the patient's particular disease phenotype, we need to much better understand the molecular pathways associated with disease expression and how these might be influenced by targeted therapy. There are 6 classes of biologic (TNFi, IL-17i, IL12/23, and IL23i) or targeted synthetic (JAKi, PDE4i) therapies currently licensed or likely to be approved shortly, and knowing their specific effects on molecular pathways involved in disease expression should be a key focus of study. Other challenges include the lack of head-to-head trials and the absence of agreement on outcome measures in clinical trials for features such as dactylitis, enthesitis, or axial involvement. Better understanding of disease pathogenesis will assist treatment selection and likely add further to the list of possible targets for therapy (See page 443). FitzGerald et al further teach that Despite this considerable progress, there remains a group of treatment-resistant patients, and many of them go through a lengthy period of “trial and error” where they cycle through several treatments before eventually but not always landing on a treatment that works. There has to be a better way, and it is hoped that careful evaluation of patients at baseline, including clinical, genetic, and proteomic profiling, will identify which patients are likely to respond to which treatment. Achieving this goal would ensure that more patients will reach more stringent treatment targets such as minimal disease activity (MDA) or remission (see page 450). Thus, the state of the art has indicated there are a number of challenges that still exist with regard to psoriatic arthritis treatment. Applicant is reminded that generally, in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus (Enzo Biochem, Inc. v. Gen- Probe Inc., 323 F.3d 956 (Fed. Cir. 2002); Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004); Regents of the University of California v. Eli Lilly Co., 119 F.3d 1559 (Fed. Cir. 1997)). A patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017) at page 1358). An adequate written description must contain enough information about the actual makeup of the claimed products — “a precise definition, such as structure, formula, chemical name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (Amgen page 1361).
Adequate written description requires more than a mere statement that is part of the invention. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chungai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
The University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that: …To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines Inc. 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus an Applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2dat1966.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow person of ordinary skill in the art to recognize that he or she invented what is claimed’”. The courts have decided: the purpose of the "written description" requirement is broader than to merely explain how to "make and use"; the Applicant must convey with reasonable clarity to those skilled in the art, that as of the filing date sought, he or she was in possession of the invention. The invention is for purposes of the “written description” inquiry, whatever is now claimed. See Vas-Cath, Inc v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).
Furthermore, the written description provision of 35 USC §112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993). And Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Moreover, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has the Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. Therefore for all these reasons, the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that Applicant had possession of the claimed invention at the time the instant application was filed.
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 1-2, 4, 6, 8, 23, 32, 34, 36, 38 are 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 pre-AIA the applicant regards as the invention.
Claim 1 is drawn to a method of treating psoriatic arthritis comprising administering an anti-IL-23p19 antibody hum13B8-b to a patient in need thereof, wherein the patient is subcutaneously administered a first dose of the antibody on week 0 and a subsequent dose at every 12 weeks thereafter up to week 48; and wherein the antibody huml3B8-b comprises:(i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1; and(ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2.
Claims 23 is drawn to a method of determining the efficacy of an anti-IL- 23p19 antibody for the treatment of psoriatic arthritis comprising administering an anti- IL-23p19 antibody hum13B8-b to a patient and measuring the patient's Psoriasis Area and Severity Index (PASI) and American College of Rheumatology (ACR) 20/50/70 response, wherein the patient is subcutaneously administered a first dose of the antibody on week 0 and a subsequent dose at every 12 weeks after the first dose up to week 48; and wherein the antibody hum13B8-b comprises:(i) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1; and(ii) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; wherein:(a) an ACR20 response value of at least 40% at week 24 indicates the efficacy of the antibody;(b) an ACR50 response value of at least 20% at week 24 indicates the efficacy of the antibody; or (c) an ACR70 response value of at least 10% at week 24 indicates the efficacy of the antibody, and wherein:(1) at least a 75% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody; (2) at least 90% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody. It is unclear as to how the claim limitations “at least a 75% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody” and “at least 90% improvement from baseline value in Psoriasis Area and Severity Index at week 52 indicates the efficacy of the antibody” can be achieved if the dosing frequency ends at 48 week? The method of treating recites that the dosing frequency ends at 48 weeks, how are the assessments made beyond 48 weeks (e.g. 52 weeks)? Does the dosing frequency end at 48 weeks and assessments are made through 52 weeks? Clarification and/or correction is required.
Status of Claims
No claims allowed.
Conclusion
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/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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