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 .
Claims 1-47, submitted on 28 September 2023, represent all claims currently under consideration.
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.
Priority
This application claims priority to provisional application US 63/11,954, filed 30 September 2022. The effective filing date is 30 September 2022.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7 and 10-11 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 7 and 10-11 depend on Claim 1, which claims a method for treating a patient having moderate to severe hidradenitis suppurativa. Claims 7 and 10-11 state that the patient has HS lesions in at least two distinct anatomic areas prior to initiating treatment, has an AN count equal to or greater than 5 prior to initiating treatment, and has a draining fistula count of less than or equal to 20 prior to initiating treatment. Each of these are characteristics of a patient having moderate to severe HS, and thus, these claims do not further limit Claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7 and 10-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kozera (Journal of the American Academy of Dermatology, Volume 87, Issue 6, Pages 1440-1442, Published Online: 4 August 2022).
Kozera describes a retrospective cohort study of the use of upadacitinib for the treatment of hidradenitis suppurativa. JAK inhibition has been identified as a potential novel strategy in the management of HS. A retrospective study cohort study of all patients with moderate to severe HS treated with upadacitinib monotherapy at their institution between October 2021 and May 2022. 20 patients were identified. All patients received 15 mg upadacinitib per day until week 4 and individuals not achieving HS clinical response at week 4 were increased to upadacitinib 30 mg per day. Patients were then reviewed at weeks 12 and 24. Included patients had no surgical intervention, intralesional steroid injections, or concomitant antibiotics for the first 24 weeks of treatment. Fifteen of 20 (75%) of individuals achieved HiSCR50 at week 4, increasing to 100% at week 12 and maintained at week 24. HiSCR75 rates were obtained in 6/20 (30%) patients at week 4, increasing to 19/20 (95%) at week 12 and maintained at week 24. HiSCR90 rates were recorded in 4/20 (20%) of patients at week 4 and 6/20 (30%) at week 12, and maintained at week 24. International Hidradenitis Suppurativa Severity Score System Scores reduced significantly during therapy. Dermatology life quality index scores and pain rating scores reduced significantly by week 4 of therapy. Four of 20 (20%) of individuals experienced flares (defined as any new lesions) during treatment. All individuals reported new abscesses (1 or 2 abscesses) in contrast to their previous experience of flares with smaller nodules, possibly implying a differential immunological basis for the development of abscesses compared with nodules and tunnels. Overall, the single-center experience of upadacitinib monotherapy for HS was positive. Escalation to 30-mg dosing is strongly associated with improved outcomes in Hurley stage 3 disease.
While Kozera does not explicitly disclose each of the claims in this study, Kozera discloses a method wherein a patient having moderate to severe HS is treated with 30 mg of upadacitinib for 12 weeks, and demonstrates clinical response. As such, each of the limitations to the claims are met as this method will inherently produce these results (See MPEP § 2112 III): Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102 and 103 rejection is appropriate for these types of claims as well as for composition claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1-47 are rejected under 35 U.S.C. 103 as being unpatentable over Kozera (Journal of the American Academy of Dermatology, Volume 87, Issue 6, Pages 1440-1442, Published Online: 4 August 2022).
The teachings of Kozera are described previously and are fully incorporated into this rejection.
Kozera does not teach that the patient did not respond to antibiotics, anti-TNF therapy or the use of a maintenance dosing of 15 mg following a 16 week induction dosing of 30 mg of upadacitinib.
Regarding Claims 8, 9, and 29, Kozera does not explicitly state that the patients which are treated did not respond to antibiotics or anti-TNF therapy. However, it flows from what is taught by Kozera that this treatment would be useful in this subset of patients. The artisan would recognize that the treatment method disclosed by Kozera is highly effective in the treatment of HS, and that applying this treatment to this subset of patients which have not responded to other therapeutics would result in the relief of symptoms.
Regarding Claims 28 and 47, Kozera does not explicitly disclose a maintenance dose of 15 mg of upadacitinib following 16 week of oral administraiton of 30 mg of upadacitinib. However, it would be obvious to one of ordinary skill in the art to reduce the dose of upadacitinib to a maintenance dose following 16 weeks of treatment in view of the data of Kozera. Kozera demonstrates that after 12 weeks of treatment, 30% of patients had reached HiSCR90, with 95% of patients reaching HiSCR75 at 12 weeks. The artisan would recognize that the treatment of 30 mg daily has reduced symptoms of the condition, and would have a reasonable expectation that reducing to a maintenance dose of 15 mg would not result in a recurrence of symptoms. The artisan would be motivated to reduce the dosage to mitigate any potential side effects of the therapeutic, as higher dosages of therapeutics are known in the art to be associated with off-target effects.
While Kozera does not explicitly disclose each claim in this study, Kozera discloses a method wherein a patient having moderate to severe HS is treated with 30 mg of upadacitinib for 12 weeks, and demonstrates clinical response. As such, each of the limitations to the claims are met as this method will inherently produce these results (See MPEP § 2112 III): Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102 and 103 rejection is appropriate for these types of claims as well as for composition claims.
Conclusion
Claims 1-47 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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/P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625