Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Status
The remarks filed and amendments filed 05/30/2026 are acknowledged.
Claims 1-3, 5-6, 10, 12, 14-15, 17-20, 25-27, and 30 are pending.
Claim 18 is amended.
Claims 4, 7-9, 11, 13, 16, 21-24, and 28-29 are cancelled.
Claims 1-3, 5-6, 10, 12, 14-15, 17-20, 25-27, and 30 are under examination.
Maintained Rejections
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 1-3, 5-6, 10, 12, 14-15, 17-20, 25-27, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Menter et al., 2020 (8/30/2023 PTO-892), in view of FDA, 2020 (8/30/2023 PTO-892) Reich, 2020 (03/13/2024 PTO-892), and Bagel et al., 2018 (12/01/2025 PTO-892).
Note: Applicant defines the anti-IL-23p19 antibody hum13B8-b as tildrakizumab [see paragraph 71 of the specification] and that tildrakizumab can refer to ILUMYA (tildrakizumab-asmn) [see paragraph 72 of the specification]. Therefore, the antibody taught by Menter and Reich, tildrakizumab, and the antibody taught by FDA, ILUMYA, are the same as the claimed antibody, with a light chain SEQ ID NO: 1 and a heavy chain SEQ ID NO: 2.
Regarding claims 1-3, 5-6, 10, 12, 18-20, and 30, Menter teaches that patients with moderate to severe scalp plaque psoriasis received subcutaneous tildrakizumab (pharmaceutical composition) [page e803, left column, second paragraph] and that tildrakizumab treatment resulted in rapid, progressive reduction in scalp psoriasis [page e803, right column, third paragraph]. Menter further teaches administering tildrakizumab 100 mg subcutaneously to patients at weeks 0, 4, and every 12 weeks thereafter [page e803, left column, first paragraph].
Since Menter teaches administering tildrakizumab [page e803, left column, second paragraph], and that the tildrakizumab treatment resulted in rapid, progressive reduction in scalp psoriasis [page e803, right column, third paragraph], then a therapeutically effective amount of tildrakizumab was necessarily administered to the patient.
However, Menter does not specifically teach that the subsequent dose is administered for up to 72 weeks or wherein the patient has an affected Scalp Surface Area (SSA) of at least 50% and a criterion selected from the group consisting of a Psoriasis Area and Severity Index (PASI) score of at least 16.7, and a Physician Global Assessment (PGA) score of 3 ("moderate") or 4 ("severe").
FDA teaches ILUMYA, also known as tildrakizumab-asmn, is administered by subcutaneous injection [page 1, see Dosage and Administration] and is administered at a dose of 100 mg at weeks 0 (first dose), 4 (second dose), and every twelve weeks thereafter (subsequent dose) up to 64 weeks [page 5, see Clinical Studies]. Additionally, FDA also teaches administering ILUMYA to subjects that were male, female, and white (i.e. 71% males, thus, 29% were female, and 81% white) [page 3, see 6.1 Clinical Trials Experience, third paragraph] and teaches treating subjects that have a PGA score of ≥3 (moderate) with ILUMYA 100mg [page 5, see Clinical Studies].
Reich teaches administering tildrakizumab to patients with moderate-to-severe plaque psoriasis up to 148 weeks [see Abstract and page 607, left column, second paragraph], with PASI 75 responses well maintained in 8 out of every 10 patients through 148 weeks of treatment, and stable Psoriasis Area and Severity Index (PASI) 90 and PASI 100 responses, with 60% of patients having PASI 90 responses at week 148 [page 182, right column, second paragraph], which demonstrates long-term efficacy and safety for tildrakizumab for patients with moderate-to-severe psoriasis treated for up to 3 years (156 weeks) [page 182, right column, first paragraph]. Reich also teaches that psoriasis is a chronic disease which requires long-term treatment [page 182, right column, first paragraph].
Bagel teaches a patient population with chronic scalp psoriasis in need of treatment that has a mean SSA of 42.3 +/- 15.0% at baseline [page 28, middle column, sixth paragraph; Table 2]. Thus, this encompasses patients with an affected SSA of at least 50%.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered the IL-23p19 antibody hum13B8-b (tildrakizumab) to treat plaque psoriasis of the scalp at weeks 0, 4, and every twelve weeks thereafter, as taught by Menter, to patients who are white, male, or female with a PGA score of ≥3, as taught by FDA, and with an affected SSA of at least 50%, as taught by Bagel, for up to at least 72 weeks, as taught by Reich. MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists.” One would be motivated to administer the antibody at weeks 0, 4, and every twelve weeks thereafter because this is a known dosing schedule of the antibody in the art, and therefore would have a reasonable expectation of success. Additionally, one would be motivated to administer the antibody for at least up to 72 weeks because Reich teaches that treating patients with moderate-to-severe plaque psoriasis with tildrakizumab is effective and safe up to 148 weeks, and since psoriasis is a chronic disease, it requires long-term treatment. One would further be motivated to administer the antibody to patients who are white, male, or female and who have a PGA score of ≥3 and an affected SSA of at least 50% because FDA teaches administering ILUMYA to treat white male and female patients with a PGA score of ≥3 and Bagel teaches that patients with scalp psoriasis that have an affected SSA of at least 50% are in need of treatment. Therefore, there would be a reasonable expectation of success in administering the antibody to this patient population in order to treat plaque psoriasis of the scalp.
Further, the limitations of wherein the administration of the antibody results in the patient achieving an Investigator Global Assessment (IGA) score for the scalp of "clear" or "almost clear" with at least a 2-point reduction from Baseline at Week 16; and wherein administration of the antibody results in the patient achieving Psoriasis Scalp
Severity Index (PSSI) 90 at Week 16, as set forth in instant claim 1, and the limitation of wherein administration of hum 13B8-b results in an Investigator Global Assessment
(IGA) mod 2011 rating scale (Scalp) score of "clear" or "almost clear" with at least a 2-point reduction from the patient's baseline score at week 16; and wherein administration of hum 13B8-b further results in a significant improvement from the patient's baseline score for the Psoriasis Scalp Severity Index (PSSI) at week 16, as set forth in instant claim 18, are results of the administration of the antibody and are therefore inherent to the antibody itself. Applicant is reminded that chemical compounds and their properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)). A person of ordinary skill in the art would recognize that these are properties of the anti-IL-23p19 antibody hum13B8-b.
Claims 14-15, 17 and 25-27 are included in this rejection because these results of the administration of the antibody are inherent to the antibody itself. Applicant is reminded that chemical compounds and their properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)). A person of ordinary skill in the art would recognize that these are properties of the anti-IL-23p19 antibody hum13B8-b.
Response to Arguments
The rejections of claims 1-3, 5-6, 10, 12, 14-15, 17-20, 25-27, and 30 under 35 U.S.C. 103 over Menter, FDA, Reich, and Bagel are maintained. On pages 7-8 of the remarks, Applicant argues that the combination of Menter, FDA, Reich, and Bagel does not provide a reason to treat the specifically claimed patient with a reasonable expectation of success because a person of ordinary skill in the art reading Menter would have understood that close to complete clearance of the scalp was not achieved for patients having higher baseline PASih scores, even out to 28 weeks, and that a person of ordinary skill in the art reading Menter would thus not have expected the claimed results at 16 weeks, which were achieved starting with patients having more severe psoriasis, and that nothing in FDA, Reich or Bagel provide any evidence that overcome this disclosure in Menter. This is not found persuasive because, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Examiner relied upon the teachings of Menter, FDA, Reich, and Bagel and the Examiner clearly articulated why it would have been obvious to combine the prior art teachings to arrive at the claimed method with a reasonable expectation of success. See rejection above. The fact that Applicant may have measured a specific outcome does not make the method any less obvious. Regarding Applicant’s argument that a person of ordinary skill in the art would not have expected the claimed results at 16 weeks, this relates to the arguments of inherency and is addressed below.
On pages 8-9 of the remarks, Applicant argues that the claimed methods involve administering the recited antibody to a specific patient population to achieve certain results and that selection of this population and the results achieved are not inherently disclosed in the cited references. Applicant further argues that Menter discloses administration to a different patient population than recited in the claims and that Menter not only does not necessarily disclose the recited results, it actually fails to achieve the recited results. This is not found persuasive because, to reiterate, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Examiner relied upon the teachings of Menter, FDA, Reich, and Bagel and the Examiner clearly articulated why it would have been obvious to combine the prior art teachings to arrive at the claimed method. See rejection above.
Further, these arguments are not found persuasive because the Examiner has provided a basis in fact that supports the determination that the inherent characteristics necessarily flow from the teachings of the applied prior art. The Examiner established that the prior art (i.e. Menter, FDA, and Reich) administers the same drug (i.e. hum13B8-b; tildrakizumab; ILUMYA) to the same patient population (i.e. a patient with scalp psoriasis) at the same dosing schedule as claimed, and the prior art (i.e. FDA and Bagel) also sets forth a clear motivation to treat the claimed patient population (i.e. white, male, or female and who have a PGA score of ≥3 and an affected SSA of at least 50%). Therefore, the same results of “wherein administration of the antibody results in the patient achieving an Investigator Global Assessment (IGA) score for the scalp of "clear" or "almost clear" with at least a 2-point reduction from Baseline at Week 16; and wherein administration of the antibody results in the patient achieving Psoriasis Scalp Severity Index (PSSI) 90 at Week 16”, as set forth in instant claim 1, and the same results of “wherein administration of hum 13B8-b results in an Investigator Global Assessment (IGA) mod 2011 rating scale (Scalp) score of "clear" or "almost clear" with at least a 2-point reduction from the patient's baseline score at week 16; and wherein administration of hum13B8-b further results in a significant improvement from the patient's baseline score for the Psoriasis Scalp Severity Index (PSSI) at week 16”, as set forth in instant claim 18, must flow from the administration of this antibody. Applicant’s claims do not require any additional steps beyond the administration of the antibody (i.e. hum13B8-b; tildrakizumab; ILUMYA) that would contribute to these results; Thus, the results must be the actions of the antibody itself, and therefore, must be a result of the antibody itself when administered to the specific patient population. The functional result limitations flow from the nexus of the only active step required by the claims which is administering the antibody. The administration of the antibody (i.e. hum13B8-b; tildrakizumab; ILUMYA) to treat psoriasis of the scalp in the specific patient population and at the specific dosing schedule is taught and/or is obvious in the applied prior art, and accordingly, the functional result limitations do in fact flow from the teachings of the applied prior art.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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