RESPONSE TO APPLICANT’S AMENDMENT
1. Applicant's amendment, filed 02/06/2026, is acknowledged.
2. Claims 1-3, 5-17 are pending.
3. Claims 5-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
4. Claims 1-3 and 13-17 are under examination as they read on a method of treating hidradenitis suppurativa, comprising administering a medicament comprising an IL-17A- and/or IL-17F-inhibitor to a subject, wherein the subject has been identified as having elevated levels of one or more biomarkers selected from (a) LTO1, (b) CSF3, (c) OSM, (d) PLA2G2A, or (e) a combination of IL17A and TNC and the species of (a) LTO1, (b) CSF3 (G-CSF), and (c) OSM as the biomarkers.
5. The Examiner thanks Applicant’s representative for pointing out that the election filed, 07/29/2025, was made without traverse.
6. Applicant’s IDS, filed 02/06/2026, is acknowledged. However, all the foreign and NPL references were crossed out because they were not supplied.
7. The following new grounds of rejection are necessitated by the amendment submitted 02/06/2026.
8. The following is a quotation of 35 U.S.C. 112(a) (Pre-AIA 35 U.S.C. 112, first paragraph):
(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.
9. Claims 1-2 and 13-17 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 for the same reasons set forth in the previous Office Action mailed 08/08/2025.
Claim 1 encompasses a broad genus of IL-17A and/or IL-17F-inhibitors in the treatment of hidradenitis suppurative.
Claim 2 encompasses a broad genus of anti- IL-17A and/or IL-17F nanobodies in the treatment of hidradenitis suppurativa.
Claim 13 encompasses a broad genus of antibodies or nanobodies that inhibit IL-17A or antibodies or a broad genus of antibodies or nanobodies that inhibit the combination of IL-17A and IL17F.
Applicant’s arguments, filed 02/06/2026, have been fully considered, but have not been found convincing.
Applicant asserts that inhibitors of IL17A and/or IL17F are known in the art. According to MPEP 2164.01 and 2163(II)(A)(3), Applicant is not required to disclose what is already known in the art:
"A patent need not teach, and preferably omits, what is well known
in the art. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331,
1332 (Fed. Cir. 1991); Hybritech, Inc. v. MonoclonalAntibodies,
Inc., 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed. Cir. 1986), cert.
denied, 480 U.S. 947 (1987); and Lindemann Maschinenfabrik
GMBH v. American Hoist & Derrick Co., 730 F.2d 1452, 1463,
221 USPQ 481, 489 (Fed. Cir. 1984)."
"What is conventional or well known to one of ordinary skill in the
art need not be disclosed in detail. See Hybritech Inc. v.
MonoclonalAntibodies, Inc., 802 F.2d at 1384, 231 USPQ at 94.
See also Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078,
1085 (Fed. Cir. 2005) ("The 'written description' requirement must
be applied in the context of the particular invention and the state of
the knowledge.... As each field evolves, the balance also evolves
between what is known and what is added by each inventive
contribution.")."{P73760 06
Applicant asserts that Applicant is not required to provide the USPTO an exhaustive list of IL-17A- and/or IL-17F-inhibitors in the specification as filed. Indeed, what is conventional or well-known is preferably omitted from the specification.
This is not found persuasive because the instant claims encompass a broad genus of antibodies and a broad genus of nanobodies that inhibit IL-17A and/or IL-17F. The claims encompass six antibody and nonobody classes: anti-IL-17A antibodies, anti-IL-17A nanobodies, anti-IL-17F antibodies, anti-IL-17F nanobodies, anti-IL-17A and IL-17F antibodies and anti-IL-17A and IL-17F nanobodies. While Applicant asserts that claimed genus of those antibody/nanobody inhibitors are known in the prior art, Applicant fails to point where claimed genus of antibodies and nanobodies that inhibits IL-17A and/or IL-17F and treat hidradenitis suppurativa can be found. Thus, Applicant has not provided evidence that the “known in the art” antibodies have the specific inhibiting and treating properties required by the claims. This argument is therefore unpersuasive.
Moreover, the specification as filed does describe several antibodies and/or nanobodies capable of functioning as IL-17A- and/or IL-17F-inhibitors, including Sonelokimab, Bimekizumab, Secukinumab, Ixekizumab, Brodalumab, Netakimab, and Izokibep (see, e.g., para. [211]).
This int found persuasive because the claims encompass six different antibody/nanobody classes while the specification provides only 5 antibodies (Bimekizumab (anti- IL-17A and IL-17F antibody), Secukinumab (anti-IL-17A antibody), Ixekizumab (anti- IL-17A antibody), Brodalumab (anti- IL-17A antibody), Netakimab (anti- IL-17A antibody)); one nanobody (Sonelokimab (anti- IL-17A and IL-17F nanobody)) and one fusion protein (Izokibep).
The specification discloses a single antibody of anti- IL-17A and IL-17F antibody (Bimekizumab), a single anti- IL-17A and IL-17F nanobody (Sonelokimab), four anti-IL-A antibodies (Brodalumab, Netakimab, Ixekizumab and Secukinumab), no species for IL-17F antibodies or nanobodies, IL-17A nanobodies within the claimed genus of antibodies, the specification does not describe representative examples to support the full scope of the claims.
With respect to representative number of species,
see AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014)
Also, see MPEP 2163 II(A)(3)(a))(ii):
A representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions 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. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
Applicant notes that the Office relies on Amgen Inc. v. Sanofi, 125 USPQ2d 1354 (Fed. Cir. 2017) as well as USPTO guidance issued in February 2018 for examining claims drawn to antibodies. However, Applicant submits that the present application is inapposite to the Amgen case as well as the cited guidance document. The presently claimed subject matter relates to a method of treatment of a novel and non-obvious patient population. The recited treatment embraces use of known antibodies and/or nanobodies capable of inhibiting IL-17A and/or IL- 17F. In contrast, the claims at issue in Amgen were directed to a genus of novel antibodies defined by their function. Further, the guidance memo relied upon by the Office states that adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen. That is not the situation here. In the present case, IL-17A and IL-17F are not newly characterized antigens, and Applicant is not attempting to claim an antibody (or a nanobody), much less by its ability to bind a newly characterized antigen. Applicant's claims are instead directed to methods of treatment.
This argument is unpersuasive, because the claimed methods require using antibodies that have specific functional properties. Even if IL-17A and IL-17F are not newly characterized antigens, the claims require using antibodies having specific properties, and the Specification does not describe those antibodies in the manner required by 35 U.S.C. § 112, first paragraph.
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.
In University of Rochester, the "claimed method depend[ed] upon finding a compound that selectively inhibits PGHS-2 activity. Without such a compound, it is impossible to practice the claimed method of treatment." Id. ( citation omitted). Similarly here, the claimed methods cannot be practiced without antibodies having the inhibiting or treating activities recited in the claims. Applicant's argument that the claims are adequately described because they are directed to a method, not a composition of matter, is therefore unpersuasive.
10. 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.
11. Claims 1-3 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Yao et al (Drugs of the Future, 47(8):567-573, 2022) or MoonLake (Press Release, May 12, 2022) or Merck KGaA (May 03, 2021), each in view of Kimball (Experimental Dermatology. 2022;31:1522–1532) and Flora et al ( PLoS ONE 18(11): e0282763) for the same reasons set forth in the previous Office Action mailed 08/08/2025.
Kimball et al further teach that IL-17A gene signatures were increased in HS lesional vs non-lesional or healthy skin. Further, at week 16, the proportion of HS-PGA responders was significantly higher in the CJM112 300 mg treatment group compared to placebo (32.3% [10/31] vs 12.5% [4/32]; p = 0.03) (Figure 4). This study met one of its primary pre-defined dual efficacy criteria; CJM112 300 mg showed a superior treatment effect with a higher HS-PGA responder rate than placebo, with a posterior probability of superiority being 97% (difference between groups 0.194 [95% credibility interval: −0.004; 0.392]). Although there was a statistically significant higher proportion of responders in the CJM112 300 mg treatment group compared with the placebo, the target efficacy difference in favour of CJM112 300 g of at least 30%, with at least 60% posterior probability was not met (14.6%). The HS-PGA responder rate was higher in the CJM112 300 mg group compared with the placebo at Weeks 2, 4, and 12, although no statistically significant differences were found between the CJM112 300 mg and placebo groups at these time points (Figure 4).
Claim 13 is include because Sonelokimab inhibits the combination of IL-17A and IL-17F. Further, secukinumab and ixekizumab (both monoclonal antibodies which neutralize IL-17A), bimekizumab (monoclonal antibody neutralizing both IL-17A and IL-17F) and brodalumab (IL-17A receptor-antagonist) (Kimball et al, page 1523, left col., 3rd ¶).
Claim 14 is included because Kimball et al teach that median expression levels of defined IL-17A signalling pathways are visualized in the heat map. Each block depicts the color-graded level of the expression in this particular RNA sample with blue showing the minimal and red the maximal level for the respective gene set (see Fig. 1 ligand and Transcriptomic Analysis Fig. S4 and SUPPLEMENTARY METHODS). Flora et al teach skin biopsy mRNA quantification assay (see Materials and methods, page 9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to target subject having elevated levels of IL17A biomarker taught by Kimball and TNC taught by Flora et al reference in the method of treatment HS with Sonelokimab taught by Yao et al, MoonLake and Merck because both elevated levels of IL17A and TNC are biomarker for hidradenitis suppurativa. It is prima facie obvious to combine two HS biomarker each of which is taught by prior art to be useful for identifying hidradenitis suppurativa to form third combination biomarker that is to be used for very same purpose; idea of combining them flows logically from their having been individually taught in prior art. In re Kerkhoven, 205 USPQ 1069, CCPA 1980. See MPEP 2144.06. Further, “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc. 550 U.S. 398, 416 (2007).
Applicant’s arguments, filed 02/06/2026, have been fully considered, but have not been found convincing.
Applicant asserts that Kimball and Flora fail to compensate for the deficiencies of Yao, MoonLake and Merck. Kimball discloses, for example, that IL-17A gene signatures were increased in HS lesional vs. non-lesional or healthy skin (see Abstract). Kimball also teaches that there is a role for IL-17A-targeting therapies in the treatment of moderate-to-severe HS (see, e.g., Discussion on page 1528). However, Kimball fails to teach or suggest treating a patient population having elevated levels of a combination of IL-17A and TNC with an IL-17A- and/or IL-17F-inhibitor. Indeed, the Office fails to point to any disclosure of TNC in Kimball at all. Kimball also fails to teach or suggest that a patient population having elevated levels of a combination of IL-17A and TNC would have a better clinical response to an IL17A and/or IL-17F-inhibitor compared to unselected patients.
Applicant submits that Flora also fails to compensate for the deficiencies of Yao, MoonLake, Merck, and Kimball. Flora reports utilization of gene expression panels and immunohistochemistry to identify fibroblast subpopulations in HS tissue and their relationship to disease severity and lesion morphology (see, e.g., Abstract). However, Flora does not suggest treating a patient population having elevated levels of a combination of IL-17A and TNC with an IL-17A and/or IL-17F inhibitor. Instead, Flora points to use of a spleen tyrosine kinase inhibitor to achieve reduced expression of fibroblast and epithelial-mesenchymal transition associated genes (see, e.g., Abstract and Discussion). Flora also fails to teach or suggest that a patient population having elevated levels of both IL-17A and TNC would have a better clinical response compared to unselected patients.
Applicant submits that at least for the reasons discussed above, the obviousness rejection appears to be based on improper hindsight and not based on information from the cited documents themselves. There is no disclosure in the cited art which teaches or suggests that a combination of IL-17A and TNC may be used as to identify a subpopulation of HS subjects having an improved response to an IL-17A and/or IL-17F inhibitor compared to an unselected patient population. As such, one of skill in the art at the time of Applicant's filing would not have had a reasonable expectation of success in combining the teachings of these documents in a manner as set forth in the Office Action to achieve a method of treating HS as recited in the present claims.
This is not found persuasive because it would have been obvious to apply the biomarker combination of IL-17A and TNC when each is taught as a biomarker to the same HS patient population as taught by Kimball and Flora. The Examiner has provided sound scientific reasoning or a sufficient rationale for the combination as proposed.
It remains the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to target subject having elevated levels of IL17A biomarker taught by Kimball and TNC taught by Flora et al reference in the method of treatment HS with Sonelokimab taught by Yao et al, MoonLake and Merck because both elevated levels of IL17A and TNC are biomarker for hidradenitis suppurativa. It is prima facie obvious to combine two HS biomarker each of which is taught by prior art to be useful for identifying hidradenitis suppurativa to form third combination biomarker that is to be used for very same purpose; idea of combining them flows logically from their having been individually taught in prior art. In re Kerkhoven, 205 USPQ 1069, CCPA 1980. See MPEP 2144.06. Further, “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc. 550 U.S. 398, 416 (2007).
Applicant submits that knowledge of Applicant's disclosure must be put aside in reaching a determination of obviousness, and impermissible hindsight must be avoided. MPEP 2142. This is because a legal conclusion of obviousness must be reached on the basis of the facts gleaned from the prior art. Applicant submits that the facts gleaned from the cited combination of documents do not suggest a combination of features as claimed. Applicant further submits that the Office's attempt to reconstruct Applicant's claimed subject matter from the cited combination of documents suggests hindsight bias on the part of the Office insofar as one of ordinary skill in the art, having Yao, MoonLake, or Merck in hand, would not have turned to Kimball or Flora to achieve the subject matter as claimed. And even if the skilled artisan had turned to all of the cited documents in combination, together they do not suggest a treatment method as claimed.
This combination is not hindsight, as alleged by Applicant, but merely scientific common sense. “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc. 550 U.S. 398, 416 (2007). Applicant have not explained what knowledge needed to be gleaned by the Examiner from the specification that is not found in the recited references in order to arrive at the claimed method. The rejection of record has made specific reference to disclosures and motivations in the prior art cited references.
Applicant submits that the Office asserts that claim 4 (the features of which have now been incorporated into claim 1) was included in the rejection "...because the combined reference teachings arrived to targeting subjects having elevated levels of IL17A and TNC combination who are considered to be patients who have a better clinical response compared to unselected patients" (Office Action at p. 9, penultimate paragraph). However, the cited documents do not explicitly arrive at any such targeting, and the Office fails to demonstrate or explain how the cited documents otherwise achieve such a surprising result. Applicant submits that the claimed subject matter is not obvious over the combination of Yao, MoonLake, Merck, Kimball and Flora for at least this reason as well.
With regard to new the currently pending claims, including new claims 15-17, Applicant directs the Examiner's attention to Example 4 and Fig. 22 (reproduced below):
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media_image1.png
366
858
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Greyscale
As shown in Fig. 22, using the “Subgroup Identification based on Differential Effect Search” (SIDES) analysis (Lipkovich et al., StatMed.30(21.260-21 (2011)), subgroups of patients with higher biomarker expression levels were shown to demonstrate an enhanced clinical outcome in response to 120 mg sonelokimab, as evidenced by the delta to placebo in HiSCR75 response compared to unselected patients. In other words, the inventors have surprisingly demonstrated that each of a) LOT1, b) a combination of IL17A and TNC, c) G-CSF, d) OSM, and e) PLA2G2A is capable of identifying a subject as belonging to a subgroup of patients who respond better to an IL-17A- and/or IL-17F-inhibitor compared to unselected patients. Further, as also shown in Fig. 22, with respect to each of a) - e), the delta to placebo in HiSCR75 treatment response was greater than 29%.
This is not found persuasive because (i) the showing of surprising results in the specification figure 22 cannot be clearly equated with the claimed invention. The showing of surprising results is not commensurate in scope with the invention as claimed. The claims are directed to a genus of IL-17A and/or IL-17F antibodies/nanobodies, while the showings of unexpected results is limited to a particular nanobody, sonelokimab MPEP §716.02(d). Not all the IL-17A and/or IL-17F antibodies/nanobodies would result in the surprising effect of an enhanced clinical outcome in response to 120 mg sonelokimab in subgroups of patients with higher biomarkers expression levels of (a) LTO1, (b) CSF3, (c) OSM, (d) PLA2G2A, or (e) a combination of IL17A and TNC, as evidenced by the delta to placebo in HiSCAR75 response compared to unselected patients. There is no showing that other embodiments falling within the claim will behave in a similar manner.
Thus, the results achieved occurred exclusively in an embodiment of the invention as recited in claim 1 (i.e., sonelokimab) renders the observations not commensurate in scope to claim 1, indeed, not drawn to the invention as claimed at all. The results are, therefore, of limited value in overcoming the Examiner’s strong prima facie case.
12. Claims 1-3 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Yao et al (Drugs of the Future, 47(8):567-573, 2022) or MoonLake (Press Release, June 25, 2023) or Merck KGaA (May 03, 2021), each in view of Navrazhina (Student Theses and Dissertations, 2021) for the same reasons set forth in the previous Office Action mailed 08/08/2025.
Navrazhina teaches that IL17-RA blockade reduces HS clinical activity. Ten patients completed this study. All patients (100%) achieved HiSCR at week 2 compared with baseline (Fig 1), with 5 of 10 patients achieving a 75% reduction in AN count and 3 of 10 patients achieving a 100% reduction in absolute nodule (AN, sum of nodules and abscesses) count. All 10 patients (100%) had achieved HiSCR at week 12, with 7 of 10 patients achieving a 75% reduction in AN count, and 40% of patients achieving a 100% reduction in AN count (Figure 44).
Claim 13 is include because Sonelokimab inhibits the combination of IL-17A and IL-17F. Further, secukinumab and ixekizumab (both monoclonal antibodies which neutralize IL-17A), bimekizumab (monoclonal antibody neutralizing both IL-17A and IL-17F) and brodalumab (IL-17A receptor-antagonist) (Kimball et al, page 1523, left col., 3rd ¶).
Claim 14 is included because Navrazhina teaches that they detected significant elevations of IL-17A (8.83-fold) in HS dermis with tunnels compared to the overlying epidermis (Figure 30B-D ad section 8.13, Table 4).
Applicant’s arguments, filed 02/06/2026, have been fully considered, but have not been found convincing.
Applicant asserts that Navrazhina fails to compensate for the deficiencies of Yao, MoonLake, and Merck. Navarzhina characterizes inflammatory mechanisms in HS but does not teach methods of treatment. Notably, Navrazahina discloses upregulation of certain genes in both psoriasis and HS (see, e.g., pages 37-38), as well as differently expressed proteins among HS, psoriasis and atopic dermatitis (AD) (see, e.g., Fig. 32 and text on pp. 69-70). However, the Office has failed to show where Navrazhina discloses that any of CSF3, OSM, and PLA2G2A are uniquely expressed in HS such that one of skill in the art would identify such a patient sub population for treatment, much less for treatment with an IL-17A and/or IL-17F-inhibitor. Instead, Navrazhina teaches that compared to AD and psoriasis, HS had only 11 unique DEPs (see, e.g., Navrazhina at Fig. 32 and first full paragraph on p. 7). The 11 unique DEPs do not include CSF3, OSM, and PLA2G2A. Navrazhina also fails to teach or suggest that a patient population having elevated levels of one or more of CSF3, OSM, and PLA2G2A would have a better clinical response compared to unselected patients.
This is not found persuasive because it appears that Applicant argues that their invention is not enabled because the prior art show that the claimed biomarkers are not unique to HS. However, if the specification is enabled, so is the prior art. However, if the prior art is not enabled, neither is the specification Applicant fails to show that the CSF3, OSM, and PLA2G2A biomarkers are unique only to HS as argued.
Applicant submits that the obviousness rejections appear to be based on improper hindsight and not based on information from the cited documents themselves. There is no disclosure in the cited art which teaches or suggests that CSF3, OSM, and PLA2G2A may be used to identify a subpopulation of HS subjects having an improved response to treatment with an IL-17A- and/or IL-17F-inhibitor compared to an unselected patient population. As such, one of skill in the art at the time of Applicant's filing would not have had a reasonable expectation of success in combining the teachings of these documents in a manner as set forth in the Office Action to achieve a method of treating HS as claimed.
This combination is not hindsight, as alleged by Applicant, but merely scientific common sense. “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc. 550 U.S. 398, 416 (2007). Applicant have not explained what knowledge needed to be gleaned by the Examiner from the specification that is not found in the recited references in order to arrive at the claimed method. The rejection of record has made specific reference to disclosures and motivations in the prior art cited references.
One of ordinary skill in the art would have had a reasonable expectation of success of improving response to treatment with an IL-17A- and/or IL-17F-antibodies according to the teachings of Yao, MoonLake, and Merck. Navarzhina by providing sonelokimab to a patient selected with the biomarker as HS patient as the reference discloses.
13. Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Yao et al (Drugs of the Future, 47(8):567-573, 2022) or MoonLake (Press Release, June 25, 2023) or Merck KGaA (May 03, 2021), each in view of Kimball (Experimental Dermatology. 2022;31:1522–1532) and Flora et al ( PLoS ONE 18(11): e0282763) or Navrazhina (Student Theses and Dissertations, 2021), as applied to claims 1-3 and 13-14, above and further in view of Kimball et al (Acta Derm Venereol 2018; 98: 932–937).
The teachings of Yao, MoonLake, Merck, Iimball, Flora and Navrazhina have been discussed, supra.
The reference teachings differ form the claimed invention only in the recitation that the the identified as belonging to a subgroup of patients who have an enhanced HiSCR score compared to unselected patients in claim 15, wherein the patient has an enhanced delta to placebo in HiSCR75 treatment response in claim 16, wherein the delta to placebo in HiSCR75 treatment response is greater than 29% in claim 17.
Kimball et al teach that HS clinical response (HiSCR) is a validated tool that has been used to assess treatment efficacy in clinical trials. HiSCR is designed to be a practical measure and is based on counts of easily recognizable clinical signs, including inflammatory nodules, abscesses, and draining fistulas. The HiSCR was designed based on data from a phase 2 clinical trial in patients with HS and retrospectively tested in that data set. Phase 3 clinical trials (PIONEER I and II) (18) assessing the effect of adalimumab (ADA) on HS subsequently used HiSCR as a measure of treatment response and ultimately led to approval by the US Food and Drug Administration (FDA) for the treatment of moderate to severe HS in adult patients, and by the European Medicines Agency (EMA) for the treatment of active moderate to severe HS in adult patients who have failed to respond to conventional systemic therapies. A recent systematic review of HS outcome measures concluded that good-quality validation evidence is available for the HiSCR instrument, making HiSCR an appropriate tool to use to assess anti-inflammatory treatment effect in HS (see introduction).
It would have been obvious to use HiSCR and modify the HiSCR with 75% reduction of HiSCR criteria (HiSCR75) as a validating tool to assess the efficacy of the treatments taught by Yao MoonLake, Merch for identified HS patient taught by Navrazhina because HiSCR is a practical measure and is based on counts of easily recognizable clinical signs, including inflammatory nodules, abscesses, and draining fistulas.
Claim 17 is including because achieving delta to placebo in HiSCR75 treatment response is greater than 29% is an inherent results treatment of identified (selected) patient with the anti-IL-17A and/or IL-17F antibodies. The functions recited in the wherein clause flow naturally from the teachings of the prior art. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985 (“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.”), and Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (“[T]he discovery of... a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer.”)). Here, the recited functional outcome would naturally and necessarily flow from inhibition of IL-17A and/or IL-17F by administering sonelokimab, secukinumab and ixekizumab, bimekizumab and brodalumab. Accordingly, the prior art teaches the same method, the product used in the reference method are the same as the claimed method. Therefore, the claimed functional outcome would naturally and necessarily flow from inhibition of IL-17A and/or IL-17F with the administering sonelokimab, secukinumab and ixekizumab, bimekizumab and brodalumab in treating selected HS patient.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
14. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
15. Claims 1-3 and 13-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 71-75 of copending Application No. 19122557 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '557 application would render obvious at least claims 1-3 and 13-17 in the instant application (see analysis below).
The instant application and the `577 application share at least one inventor and/or assignee (e.g., MoonLake immunotherapeutics). Further, the '557 application is related to the instant application as a CON and thus no "121 shield" exists here. See filing receipt. See also MPEP § 804.01. See also Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1362 (Fed. Cir. 2008) (“the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications … This is true even if the … application was mistakenly filed … and should have been filed as a DIV application.”). See also Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F. 3d 1340, 1354 (CAFC 2009) (“Amgen does not dispute that it denominated the '178 and '179 applications continuations, that it checked the continuation application box on the submitted form, or that its applications met the PTO's definition of a continuation application in MPEP § 201.07. … Instead, Amgen argues that, because the '178 and '179 continuation applications could have been filed as divisional applications, we should treat them as such for purposes of § 121. While this argument convinced the district court to regard the '178 and '179 continuation applications as divisional applications, we are not likewise convinced. We decline to construe ‘divisional application’ in § 121 to encompass Amgen's properly filed, properly designated continuation applications.”).
Accordingly, it would have been prima facie obvious to use the kit set forth in claim 71 for “treating hidradenitis suppurativa, comprising administering a medicament comprising an IL-17A- and/or IL-IL17F-inhibitor to a subject, wherein the subject has been identified as having elevated levels of one or more biomarkers selected from (a) LTO1, (b) CSF3, (c) OSM, (d) PLA2G2A, or (e) a combination of IL17A and TNC” before the effective filing date. See Sun Pharmaceutical industries v. Eli Lilly and Co., 611F. 3d 1381, 1385 (CAFC 2010) (“our prior obviousness-type double patenting decisions in Geneva and Pfizer . … we found claims of a later patent invalid for obviousness-type double patenting a method of using the compound for a use described in the specification of the earlier patent”). See also MPEP $ 804(II)(B)(2)(“in AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (fed. Cir . 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context.”)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments, filed 02/06/2026, have been fully considered, but have not been found convincing.
Applicant submits that the Office has not sufficiently set forth a prima facie case of obviousness with regard to the claims of the '557 application. For example, the Office fails to show how it would be obvious to use a kit as claimed in the '557 application to treat a patient identified as having an elevated level of, for example, LTO1. In this regard, Applicant notes that no corresponding reagent is recited in claim 57 of the '557 application.
However, it remains the Examiner’s position that it would have been prima facie obvious to use the kit set forth in claim 71 for “treating hidradenitis suppurativa, comprising administering a medicament comprising an IL-17A- and/or IL-IL17F-inhibitor to a subject, wherein the subject has been identified as having elevated levels of one or more biomarkers selected from (a) LTO1, (b) CSF3, (c) OSM, (d) PLA2G2A, or (e) a combination of IL17A and TNC” before the effective filing date. See Sun Pharmaceutical industries v. Eli Lilly and Co., 611F. 3d 1381, 1385 (CAFC 2010) (“our prior obviousness-type double patenting decisions in Geneva and Pfizer . … we found claims of a later patent invalid for obviousness-type double patenting a method of using the compound for a use described in the specification of the earlier patent”). See also MPEP $ 804(II)(B)(2)(“in AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (fed. Cir . 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context.”)
16. No claim is allowed.
17. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Application nos.
(i) 19/187629 (US 20250251406 A1)
(ii) 19/187615 (US 20250251406 A1)
Both Application are directed to the selected HS treatment with a biomarker such as PLA2G2A, OSM and CSF3 comprising administering IL-17A and/or IL-17F inhibitors.
17. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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February 11, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644