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 .
Status of Application, Amendments and/or Claims
Applicant’s arguments, filed 21 August 2025, have been entered in full. Claims 1-46, 48, 49, 57 and 60-62 are canceled. Claims 47, 50-56, 58 and 59 are under examination.
The Loesche Declaration under 37 CFR 1.132, filed 11 September 2025, has been entered in full.
Information Disclosure Statement
The information disclosure statement(s)(IDS) (filed 3/23/25 and 11/5/25) were received. They have been placed in the application file and the information referred to therein has been considered as to the merits.
It is noted that some of the references fail to comply with the provisions of 37 CFR §§1.97, 1.98 and MPEP § 609. MPEP 609.05 [R-3] states that information disclosure statements will be reviewed for compliance with the requirements of 37 CFR 1.97 and 37 CFR 1.98 as discussed in MPEP 609.04(a) and MPEP 609.04(b). The references will be lined through and not considered by the Examiner.
Electronic document: An electronic document is one that can be retrieved from an online source (e.g., the Internet, online database, etc.) or sources found on electronic storage media (e.g., CD-ROM, magnetic disk or tape, etc.). Many references in paper format may also be retrieved as electronic documents. Other references are retrievable only from electronic sources.
The following references not considered by the Examiner for the following reasons: This is in reference to the IDS submitted on 3/23/2025. The references are electronic publications.
(1) The first set of references submitted on 3/23/2025 list numerous Clinical Trials. The cited Clinical Trials are missing the titles, the dates and a hyperlink where the references are accessible.
In addition, none of the cited Clinical Trials were actually submitted to the Office. A reproducible method of obtaining these references are for the general public once the application is published as a Patent. However, the actual reference(s) must be submitted to the Office in order for the Examiner to read and consider.
(2) The second set of references submitted on the IDS dated 3/23/25 fail to cite the electronic website where the document can be retrieved.
Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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.
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 47, 53, 54, 55 and 56 remain rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT03099980 (first submitted March 29, 2017). The basis for this rejection is set forth at pages 3-8 of the previous Office Action (18 March 2025).
Claims 50-52 remain rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT03099980, as applied to claim 47 above, and further in view of Thorlacius et al. (British Journal of Dermatology (2018) 179, pp182- 185; ePub 27 June 2017). The basis for this rejection is set forth at pages 8-9 of the previous Office Action (18 March 2025).
Claim 58 remains rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT03099980, as applied to claim 47 above, and further in view of Collier et al. (BMJ 2013;346:f2121). The basis for this rejection is set forth at pages 10-11 of the previous Office Action (18 March 2025).
Claim 59 remains rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT03099980, as applied to claim 47 above, and further in view of Alavi et al. (J Am Acad Dermatol 2015;73:555-61). The basis for this rejection is set forth at pages 11-12 of the previous Office Action (18 March 2025).
Applicant states that each of the rejections by the Office for alleged obviousness relies on Clinical Trial NCT03099980 and/or the Thorlacius reference as allegedly disclosing to a person of ordinary skill in the art a sustained therapeutically effective treatment of hidradenitis suppurativa (HS) by subcutaneous administration of secukinumab.
Applicant submits that the presently claimed invention cannot be considered obvious over the cited references at least because the cited references would not have given a person of ordinary skill in the art a reasonable expectation of success in achieving the claimed invention (as further explained in the 37 C.F.R. 1.132 affidavit by Dr. Christian Loesche). Applicant states that a skilled person would not have reasonably expected to successfully achieve a sustained HiSCR response after 52 weeks of treatment, as required by the present claims. Applicant argues that as set forth in section 2143.02 of the MPEP, a finding of obviousness requires a reasonable expectation of success in combining and/or modifying the prior art in order to arrive at the claimed invention. Applicant maintains that this requirement has not been met.
APPLICANT’S ARGUMENT ONE: Applicant argues that at the earliest effective date of the present application, there was only one FDA approved treatment option for HS, and all of the more than 40 potential treatment options described in the literature showed limited efficacy or in the case of adalimumab showed a loss of efficacy over time. Applicant argues that the field is littered with failed clinical trials for “promising” treatments, like those alleged to be disclosed in the cited references.
Applicant argues that the Cited References Fail to Overcome the Lack of Reasonable Expectation of Success From the Field as a Whole. Applicant argues that Clinical Trial NCT03099980 was an early phase I study. Applicant argues that a skilled person would understand that such studies are unlikely to achieve a successful phase III outcome and marketing approval. Applicant argues that Clinical Trial NCT03099980 was an open-label study without a control group and without any results published at the time the present application was filed. Applicant argues that given the number of failed clinical trials in this field, the high placebo responder rate, the shortcomings in the design of the trial, and the utter lack of any efficacy data, modeling, or rationale, it simply cannot be said that a skilled person would find a reasonable expectation of success in arriving at the presently claimed invention from Clinical Trials NCT03099980 alone or in combination with any of the other cited references or what was known in the field at the time the present application was filed.
Regarding the Thorlacius reference, Applicant argues that Thorlacius is a single patient unblinded case report. Applicant argues that treatment efficacy was not well demonstrated in physician-reported scores, with HiSCR AN score lowering by only 2 points and the DLQI index worsening. Applicant argues that a person of ordinary skill in the art would have reason to doubt the efficacy of secukinumab treatment in HS. Applicant argues that Thorlacius implies IL-17 blockade could provide a possible therapeutic approach in the treatment of HS. Applicant asserts that this is mere speculation and insufficient to overcome the lack of reasonable expectation of success.
Applicant’s argument have been fully considered but are not found persuasive for the following reasons:
1. MPEP 2121 Prior Art; General Level of Operability Required to Make a Prima Facie Case teaches: Prior art is presumed to be operable/enabling. When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability.
In the instant case, Clinical Trial NCT03099980 teaches HS patients and teaches subcutaneously administering 300 mg of secukinumab every week for 4 weeks, then administering every 4 wks. for 24 wks. Clinical Trial NCT03099980 teaches a primary outcome measure: Hidradenitis Suppurativa Clinical Response (HiSCR) percent of patients achieving clinical response and the framework of week 24.
The instant claims are drawn to a method of treating hidradenitis suppurativa (HS) comprising subcutaneously administering 300 mg of secukinumab weekly during weeks (wks.) 0, 1, 2, 3 and 4, then administering every two wks. or every 4 wks. after, wherein the patient sustains a clinical response as measured by a Hidradenitis Suppurativa Clinical Response (HiSCR) after 52 wks. of treatment.
The only difference between the instant claims and Clinical Trial NCT03099980, is in the instant claims the treatment is carried out for 52 wks., while the Clinical Trial NCT03099980 carries out the treatment for 24 wks.
However, it is not inventive to discover the optimum frequency of administering secukinumab by routine experimentation. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
2. Applicant arguments regarding the lack of data/efficacy in Clinical Trial NCT03099980 and the Thorlacius reference are not found persuasive because obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties. See, e.g., In re O' Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988).
The Thorlacius reference was used to reject claims 50-52. Thorlacius teaches HS patients have used different treatments over the years which includes adalimumab (i.e., TNF-alpha inhibitor) and rifampin/clindamycin (i.e., antibiotics). However, the Thorlacius reference also teaches that subcutaneously administering secukinumab on a weekly basis at 300 mg weekly for 1 month (4 weeks), followed by 300 mg every 4th week, results in improvement in the HS patient. Thorlacius et al. teach a hidradenitis suppurativa (HS) patient had reduced lesions after secukinumab treatment.
Clinical Trial NCT03099980 provides a reasonable expectation of success as it details an enabling methodology for administering secukinumab to treat HS.
Based on the combined teachings it been obvious to include HS patients who have been previously treated with a systemic agent for HS, such as TNF-alpha inhibitor, as taught by Thorlacius. HS patients have skin lesions and thus it would be obvious to employ antibiotics to treat possible skin infections.
APPLICANT’S ARGUMENT TWO: Applicant argues that the present application discloses for the first time that IL-17 inhibition can successfully treat HS (e.g., Example 1) and uses modeling and simulation based on real-world individualized patient response profiles and provides a clinical trial design (Examples 2 and 3) to demonstrate that subcutaneous administration of secukinumab can achieve sustained HiSCR as recited in the present claims. Applicant submits that the cited references do not provide a skilled person with reasonable expectation of success in achieving the claimed invention.
Applicant argues that the Office Has Misconstrued the Clinical Trial NCT03099980 Disclosure and Improperly Discounted the Present Disclosure. Applicant submits that in the Office Action of 18 March 2025, the Office argues that the trial design and results described in Example 1 of the present application were already known, citing to the Clinical Trial NCT03099980 publication. Applicant argues that this is incorrect.
Applicant states that as of the filing date of the present application, the Clinical Trial NCT03099980 provides no results and merely presents the design of a proposed small, open-label, study. Applicant argues that in contrast, the results in Example 1 are the first randomized and blinded clinical validation of IL-17 blockade in the treatment of HS. Applicant argues that these results were disclosed for the first time in the present application as filed.
Applicant states that the Office further argues that the rest of the Examples are “Prophetic” and that this argument is incorrect. Applicant states that as explained in Loesche Declaration, the extensive pharmacological modeling data provided in Example 2 of the present application is data, and would be so understood by a person of ordinary skill in the art. Applicant states that they request notice of the efficacy data provided for the first time in Examples 1 and 2 of the present application, said data being sufficient to support the invention as claimed and highlighting the vast difference between the present application and the utter lack of data in Clinical Trial NCT03099980 and the single case reports in Thorlacius.
Applicant’s argument have been fully considered but are not found persuasive for the following reasons:
1. Applicant argues that the results in Example 1 are the first randomized and blinded clinical validation of IL-17 blockade in the treatment of HS. Applicant argues that these results were disclosed for the first time in the present application as filed.
The Examiner maintains that this is incorrect. Example 1 from the instant specification teaches administering CJM112 antibody to HS patients. It is noted that CJM112 is not the same as secukinumab. While both are anti-IL-17A monoclonal antibodies, CJM112 and secukinumab are different drugs.
Furthermore, the Thorlacius reference was published before the instant inventors. The Thorlacius reference validated IL-17 blockade in the treatment of HS using secukinumab (British Journal of Dermatology (2018) 179, pp182- 185; ePub 27 June 2017).
2. Applicant states that as explained in the Loesche Declaration, extensive pharmacological modeling data is provided in Example 2.
The Examiner notes that a working example is based on work actually performed. A prophetic example describes an embodiment of the invention based on predicted results rather than work actually conducted or results actually achieved.
Thus, a working example for the instant specification would actually show experiments wherein 300 mg of secukinumab is subcutaneously administered to an HS patient weekly (wk. 0, 1, 2, 3 and 4) and then afterwards administered every 2 wks. or every 4 wks. wherein said patient sustains a clinical response that is actually measured using HiSCR after 52 wks. of treatment.
In the instant case, Example 2 clearly states, “The purpose of the modeling and simulation (M&S) work in this Example is to investigate the simulated efficacy of secukinumab in heavy subjects following the two higher dosage regimens mentioned above, 450 Q4W and 300 Q2W. We report here modeling and simulation (M&S) work that investigated responder rate of PASI 75 and PASI 90 in patients ≥90 kg in bodyweight, using the standard regimen for secukinumab in psoriasis, i.e. 300 mg Q4W, in comparison to predicted response using higher dose regimens, i.e. 450 mg Q4W or 300 mg Q2W. The main objective of the work is to use model predicted (i.e. simulated) response rates to estimate the magnitude of improvement with the higher doses in heavier patients” (see para 0198). “The modeling and simulation in this example consists of week 52 data from the secukinumab OPTIMIZE study. OPTIMIZE (NCT02409667) was a 52 week comparative, randomized, multicenter, open-label trial with blinded-assessment to evaluate the efficacy, safety and tolerability of secukinumab 300 mg SC in long-term treatment optimization in patients with moderate to severe chronic plaque-type psoriasis” (para 0206).
Example 3 states “Table 8, below sets forth details of the clinical trial design to demonstrate the efficacy of two secukinumab dose regimens compared to placebo by assessing the proportion of subjects achieving HiSCR after 16 weeks of treatment” (para 0209).
The Examiner notes that the word “simulation” is defined as “imitation of a situation or process”. The Examiner maintains that if arguments assert that Clinical Trial NCT03099980 provides no results and merely presents the design of a proposed study, the same holds true for the instant specification.
APPLICANT’S ARGUMENT THREE: Applicant submits that the Present Invention Solves a Long-Felt and Unmet Need, Finds Commercial Success, and Provides Unexpected Results Sufficient to Overcome Any Alleged Obviousness. Applicant states that as set forth in section 2145 of the MPEP, evidence of non-obviousness can include both commercial success of the invention and the presence of a long-felt need that is unsolved prior to the invention. Citing Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 4459, 467. See also, e.g., In re Piasecki, 745 F.2d 1468, 1473, 223 USPQ 785, 788 (Fed. Cir. 1984) (commercial success).
Applicant states that at the time the present invention was made there was a clear and unmet need for safe and effective long-term treatments for HS, a need that was met by this invention. Applicant argues that as reported by Fierce Pharma in 2024, “[d]espite entering the market nearly a decade after Humira, Cosentyx has quickly become a dominant force in HS. Applicant argues that in the latest Novartis investor call for Q2 2025, it was reported that the majority of patients receiving a biologic for the first time to treat HS receive secukinumab. Applicant argues that the clinical responses seen in secukinumab treatment of HS were unexpected prior to the filing of the present application. These unexpected results included, but are not limited to, the statistically significant improvement in HiSCR, as well as the sustained improvement over long periods of time (e.g., 52 weeks).
Applicant’s argument have been fully considered but are not found persuasive for the following reasons:
MPEP 716.04 teaches: THE CLAIMED INVENTION MUST SATISFY A LONG-FELT NEED WHICH WAS RECOGNIZED, PERSISTENT, AND NOT SOLVED BY OTHERS.
Establishing long-felt need requires objective evidence that an art recognized problem existed in the art for a long period of time without solution. The relevance of long-felt need and the failure of others to the issue of obviousness depends on several factors. First, the need must have been a persistent one that was recognized by those of ordinary skill in the art. In re Gershon, 372 F.2d 535, 539, 152 USPQ 602, 605 (CCPA 1967) ("Since the alleged problem in this case was first recognized by appellants, and others apparently have not yet become aware of its existence, it goes without saying that there could not possibly be any evidence of either a long felt need in the . . . art for a solution to a problem of dubious existence or failure of others skilled in the art who unsuccessfully attempted to solve a problem of which they were not aware."); Orthopedic Equipment Co., Inc. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 217 USPQ 1281 (Fed. Cir. 1983) (Although the claimed invention achieved the desirable result of reducing inventories, there was no evidence of any prior unsuccessful attempts to do so.).
Second, the long-felt need must not have been satisfied by another before the invention by the inventor. Newell Companies v. Kenney Mfg. Co., 864 F.2d 757, 768, 9 USPQ2d 1417, 1426 (Fed. Cir. 1988) (Although at one time there was a long-felt need for a "do-it-yourself" window shade material which was adjustable without the use of tools, a prior art product fulfilled the need by using a scored plastic material which could be torn. "[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved".)
Third, the invention must in fact satisfy the long-felt need. In re Cavanagh, 436 F.2d 491, 168 USPQ 466 (CCPA 1971). LONG-FELT NEED IS MEASURED FROM THE DATE A PROBLEM IS IDENTIFIED AND EFFORTS ARE MADE TO SOLVE IT. Long-felt need is analyzed as of the date the problem is identified and articulated, and there is evidence of efforts to solve that problem, not as of the date of the most pertinent prior art references. Texas Instruments Inc. v. Int’l Trade Comm’n, 988 F.2d 1165, 1179, 26 USPQ2d 1018, 1029 (Fed. Cir. 1993). OTHER FACTORS CONTRIBUTING TO THE PRESENCE OF A LONG-FELT NEED MUST BE CONSIDERED. The failure to solve a long-felt need may be due to factors such as lack of interest or lack of appreciation of an invention’s potential or marketability rather than want of technical know-how. Scully Signal Co. v. Electronics Corp. of America, 570 F.2d 355, 196 USPQ 657 (1st. Cir. 1977).
In the instant case, the long-felt need for safe and effective long-term treatments for HS was satisfied by another before the instant inventors. This is evidenced in the prosecution history of this application wherein several references (published before effective filing date of the instant case) were cited as teaching a method for treating HS. The Examiner fails to see any evidence of unexpected results regarding the use of secukinumab for the treatment of HS from the instant specification.
The Loesche Declaration Under 37 C.F.R. 1.132: The Loesche Declaration under 37 CFR 1.132, filed September 11, 2025, is insufficient to overcome the rejection of claims 47, 50-56, 58 and 59 based upon 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT03099980 (applies to claims 47, 53, 54, 55 and 56) and further in view of Thorlacius et al. (British Journal of Dermatology Volume 179, pp182-185; 2018, ePub 27 June 2017; applies to claims 50-52), Collier et al. (BMJ Volume 346:f2121, 2013; applies to claim 58) and Alavi et al. (J Am Acad Dermatol Volume 73:555-61, 2015; applies to claim 59) as set forth in the last Office action.
This is because it states that the claimed subject matter solved a problem that was long standing in the art. However, there is no evidence of a long felt but unsolved need. There is no evidence of unexpected results at the time the invention was filed. There is no evidence that the cited references would not have given a person of ordinary skill in the art a reasonable expectation of success in achieving the claimed invention.
At pages 2-3, the Declaration discusses the background of hidradenitis suppurativa (HS), including symptoms and effected regions. At pages 4-5, the Declaration cites references and states that in 2017, treatment options for moderate to severe HS had limited efficacy. The Declaration states that whether treatment could be sustained was not well studied, and available treatments like adalimumab lost effectiveness starting at 12 weeks. At page 6 and pages 12-13, the Declaration states that IL-17 inhibitors had not been clinically validated to sustainable treat HS patients.
These arguments from the Declaration are not found persuasive for the following reasons:
“A long-felt need” for safe and effective long-term treatments for HS was satisfied by another before the instant inventors. Reference Exhibit E states that adalimumab given weekly and infliximab are effective in treating HS (abstract). Reference Exhibit F states that adalimumab given weekly is effective and improves the quality of life in HS patients (page 40).
In 2015, the FDA approved Humira (adalimumab) for treating moderate to severe HS.
Regarding secukinumab, the prosecution history of this application cites several references (published before effective filing date of the instant case) as teaching a method for treating HS comprising administering secukinumab.
Regarding the failure of the discussed IL-17 inhibitors, many of these pharmaceuticals are structurally different from antibody secukinumab. For example, izokibep is a small protein therapeutic. The failure of izokibep to treat HS does not teach against using secukinumab to treat HS.
At pages 7-9, the Declaration discusses Clinical Trial NCT03099980 and argues against a reasonable expectation of success for a sustained HiSCR response after 52 weeks as recited in the claims. The Declaration cites references which purportedly teach that trials involve very limited human exposure to the drug and have no therapeutic or diagnostic goals; seventy percent of drugs move from Phase I to Phase II clinical trials, of which about 33% move to Phase III; and 54% fail to achieve marketing authorization. The Declaration states that based on the mere fact that a drug is registered for a Phase I study, there is a very low probability that the drug will successfully achieve a given outcome measure—particularly, one like the 52-week HiSCR response recited in the claims. The Declaration states that NCT03099980 does not report the results of the clinical trial and that the trial used a single arm, without a control group.
The Declaration states that HS has a waxing and waning presentation, which means that the disease naturally fluctuates between dormancy and flares. The Declaration states that a patient can have a clinical response of HiSCR50 one week and fail to achieve the clinical response another week or vice versa. When HiSCR is used as a primary endpoint, a control group is necessary given the known challenges of using HiSCR. The Declaration states that given the fact that NCT03099980 was an open-label Early Phase I study using HiSCR as a primary endpoint without a control group, it would not have been viewed as a basis for reasonably expecting success by persons of ordinary skill in the art even if efficacy data were available as of the relevant date.
These arguments from the Declaration are not found persuasive for the following reasons:
Prior art is presumed to be operable/enabling. When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability.
In the instant case, Clinical Trial NCT03099980 teaches very similar method steps to the method that is currently claimed.
The instant claims are drawn to a method of treating hidradenitis suppurativa (HS) comprising subcutaneously administering 300 mg of secukinumab weekly during weeks 0, 1, 2, 3 and 4, then administering every two weeks or every 4 weeks, after, wherein the patient sustains a clinical response as measure by Hidradenitis Suppurativa Clinical Response (HiSCR) after 52 weeks of treatment.
Clinical Trial NCT03099980 teaches HS patients and teaches subcutaneously administering 300 mg of secukinumab every week for 4 weeks, then administering every 4 weeks for 24 weeks. Clinical Trial NCT03099980 teaches a primary outcome measure: Hidradenitis Suppurativa Clinical Response (HiSCR) percent of patients achieving clinical response and the framework of week 24.
The only difference between the instant claims and Clinical Trial NCT03099980, is in the instant claims the treatment is carried out for 52 wks., while the Clinical Trial NCT03099980 carries out the treatment for 24 wks. It would be obvious to one of ordinary skill in the art to discover the optimum timing of treatment by routine experimentation.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (see also MPEP 2144.04).
The Declaration fails to provide evidence that Clinical Trial NCT03099980 would not sustain a clinical response as measured by HiSCR after 52 weeks of treatment.
At page 10, the Declaration states that similarly, Thorlacius would not create a reasonable expectation of success in 2017 that administering secukinumab according to the claimed methods would result in a sustained HiSCR response after 52 weeks of treatment. The Declaration states that Thorlacius is a case study evaluating the use of secukinumab in a single patient, a 47- year-old man with moderate-to-severe HS. Prior to treatment with secukinumab, the patient had tried over seven different treatment combinations with minimal but not long-lasting success, further emphasizing the difficulty in treating the disease and its natural fluctuations. The patient received 300 mg of secukinumab subcutaneously weekly for four weeks and then 300 mg subcutaneously every four weeks for a total of 12 weeks of treatment.
The Declaration states that the combination of the Clinical Trial and Thorlacius would not have provided a reasonable expectation that administering secukinumab according to the claimed regimen would result in a clinical HiSCR response, in particular over placebo, and specifically that secukinumab would sustain such efficacy up to and until 24-weeks, 36-weeks, 48-weeks, and 52-weeks. The Declaration states that while the patient described in Thorlacius had “great satisfaction with the treatment,” this was “not well reproduced in the physician-reported scores,” meaning that any clinical result reported by the patient lacked reproducibility. The Declaration states that after 12 weeks of treatment, the patient’s HiSCR score only decreased from 13 to 11, and his dermatology life quality index (“DLQIT’) actually worsened.
At page 11, the Declaration states that the treatment of HS is complicated by the fact that different treatments only work in some patients some of the time and, as discussed above, the disease comes and goes spontaneously meaning that an “effect” could have nothing to do with a given treatment and may just reflect the natural development of the disease. The Declaration states that is why clinical trials seeking to establish efficacy ordinarily include a placebo or active control group and a sufficient number of patients to ensure statistical significance. The Declaration states that at best, Thorlacius “imply that IL-17 blockade could provide a possible therapeutic approach in the treatment of HS”. The Declaration states that without such further investigation and data, clinicians and researchers would not have reasonably expected that the claimed methods would result in a HiSCR sustained at 52 weeks. This is supported by the fact that, as Thorlacius (2018)(a) notes, other similarly promising agents actually failed in controlled trials.
These arguments from the Declaration are not found persuasive for the following reasons:
1. Clinical Trial NCT03099980 is the primary reference. The Thorlacius reference is the secondary reference used to reject claims 50-52. Thorlacius teaches HS patients have used different treatments over the years, including adalimumab (i.e., TNF-alpha inhibitor), and rifampin/clindamycin (i.e., antibiotics).
As was stated earlier, the only difference between the instant claims and Clinical Trial NCT03099980, is that the instant claims recite that the treatment is carried out for 52 wks., while the Clinical Trial NCT03099980 carries out the treatment for 24 wks.
Clinical Trial NCT03099980 and the instant claims both teach administering the same antibody to the same patient population at the same dose. Still, the Declaration fails to provide evidence why Clinical Trial NCT03099980 would not create a reasonable expectation of success
At page 14, the Declaration states that in contrast to Clinical Trial NCT03099980 and Thorlacius, the instant application provides the randomized, blinded, and placebo-controlled data in Example 1, extensive pharmacological modeling data in Example 2 based on real-world, individual patient-level, blinded and controlled, clinical trial data, and in Example 3 the design for two placebo-controlled clinical trials using secukinumab to treat HS according to the claims. The Declaration states that these clinical trials designs, informed by the clinical data in Example 1 and the extensive pharmacological data in Example 2, ultimately were used in the SUNSHINE and SUNRISE trials. At pages 15-16, the Declaration states that clinicians would not have expected secukinumab every 4 week dosing regimen to provide a statistically significant improvement in HiSCR. The Declaration discusses the use of adalimumab for treating psoriasis. The Declaration discusses the use of adalimumab for treating HS. The Declaration cites post-filing references.
These arguments from the Declaration are not found persuasive for the following reasons:
Example 1 from the instant specification teaches administering CJM112 antibody to HS patients. CJM112 is not the same as secukinumab. While both are anti-IL-17A monoclonal antibodies, CJM112 and secukinumab are different drugs.
Example 2 from the instant specification clearly states, “The purpose of the modeling and simulation (M&S) work in this Example is to investigate the simulated efficacy of secukinumab in heavy subjects following the two higher dosage regimens mentioned above, 450 Q4W and 300 Q2W. We report here modeling and simulation (M&S) work that investigated responder rate of PASI 75 and PASI 90 in patients ≥90 kg in bodyweight, using the standard regimen for secukinumab in psoriasis, i.e. 300 mg Q4W, in comparison to predicted response using higher dose regimens, i.e. 450 mg Q4W or 300 mg Q2W. The main objective of the work is to use model predicted (i.e. simulated) response rates to estimate the magnitude of improvement with the higher doses in heavier patients” (see para 0198). “The modeling and simulation in this example consists of week 52 data from the secukinumab OPTIMIZE study. OPTIMIZE (NCT02409667) was a 52 week comparative, randomized, multicenter, open-label trial with blinded-assessment to evaluate the efficacy, safety and tolerability of secukinumab 300 mg SC in long-term treatment optimization in patients with moderate to severe chronic plaque-type psoriasis” (para 0206).
The Examiner maintains that the ”modeling and simulation based on real-world individualized patient response profiles” was established from administering secukinumab to patients with psoriasis NOT patients with hidradenitis suppurativa (HS).
Example 3 states “Table 8, below sets forth details of the clinical trial design to demonstrate the efficacy of two secukinumab dose regimens compared to placebo by assessing the proportion of subjects achieving HiSCR after 16 weeks of treatment” (para 0209).
The Declaration has not presented any experimental data actually showing experiments wherein 300 mg of secukinumab is subcutaneously administered to an HS patient weekly (wk. 0, 1, 2, 3 and 4) and then afterwards administered every 2 wks. or every 4 wks. wherein said patient sustains a clinical response as measured by HiSCR after 52 wks. of treatment.
Although the Clinical Trial NCT03099980 teaches similar method steps, the Declaration does not provide evidence why Clinical Trial NCT03099980 would not have provided a reasonable expectation of success for administering secukinumab and giving a sustained clinical response as measured by HiSCR after 52 weeks of treatment.
Secondly, MPEP 716.02(e) teaches: An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). "A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference." In re Merchant, 575 F.2d 865, 868, 197 USPQ 785, 787 (CCPA 1978) (emphasis in original). Where the comparison is not identical with the reference disclosure, deviations therefrom should be explained, In re Finley, 174 F.2d 130, 81 USPQ 383 (CCPA 1949), and if not explained should be noted and evaluated, and if significant, explanation should be required. In re Armstrong, 280 F.2d 132, 126 USPQ 281 (CCPA 1960) (deviations from example were inconsequential).
In the instant case, there is nothing of record that teaches adalimumab and secukinumab are so structurally similar that they would be expected to give the same results regarding stability, half-life, treatments, etc. Therefore, arguments discussing how adalimumab works in treating psoriasis is not evidence of unexpected results of using secukinumab every 4 week to provide an improvement in HiSCR for HS patients. Similarly, the fact that the response of adalimumab declined at 12 weeks in HS patients is not evidence of unexpected results of using secukinumab every 4 week to provide an improvement in HiSCR for HS patients.
Lastly, the arguments using references with post-fling dates as evidence of unexpected results or nonobviousness are not applicable.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
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/R.M.D/Examiner, Art Unit 1647
11/26/2025
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647