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 .
This Office Action is in reply to Applicants’ correspondence of 04/22/2026.
Applicants’ remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance. Any new grounds of rejection presented in this Office Action are necessitated by Applicants’ amendments. Any rejections or objections not reiterated herein have been withdrawn in light of the amendments to the claims or as discussed in this Office Action.
This Action is made FINAL.
Please Note: The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Presentation of Claims
37 CFR 1.121 provides rules for making amendments to the application. Of note, 1.121 (c)(4) provides:
When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of "canceled" or "not entered."
(ii) Cancellation of a claim shall be effected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as "canceled" will constitute an instruction to cancel the claim.
In the instant case multiple claims provided with the amendments of 04/22/2026 have no text but are provided with the status of “(Withdrawn)” (e.g.: claims 11, 12, 14-17, 19-21, 23-26, 28, 29, 48, 49). These claims should be presented as “Cancelled”.
Applicant is encouraged to carefully review claims to ensure that they are properly presented. In the interest of customer service and compact prosecution the instant claims are examined and Applicants are notified that future claims that are not compliant with 37 CFR 1.121 may be not entered as non-compliant.
Election/Restrictions
In the reply filed on 09/12/2025 Applicant’s elected, without traverse, the particular SNP that is rs1475658, and the agent that is an IL-33 binding antagonist.
Claims 6 and 8 are amended so that they no longer recited the elected SNP position (i.e.: rs1475658), and so claims 6 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/12/2025.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, US Provisional Application No. 62/988,993, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The instant claims encompass alleles of a SNP that are claimed as a “T allele at polymorphism rs1475658 (SEQ ID NO: 85)”. But the provisional application does not disclose or contemplated the particular SNP that is recited as SEQ ID NOs: 85 of claim 1. As such the effective filing date of the claimed methods is the filing date of the parent PCT application PCT/EP2021/056212, which is 03/11/2021.
Withdrawn Claim Rejections - 35 USC § 112 - Indefiniteness
The rejections of claims under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as set forth on pages 4-5 of the Office Action of 12/23/2025 are withdrawn in light of the amendments to the claims.
Withdrawn Claim Rejections – Improper Markush Group
The rejection of claims for containing an improper Markush grouping of alternatives, as set forth on pages 5-6 of the Office Action of 12/23/2025 is withdrawn in light of the amendments to the claims.
Withdrawn Claim Rejections - 35 USC § 101
The rejection of claims under 35 U.S.C. 101, as set forth on pages 7-9 of the Office Action of 12/23/2025 is withdrawn in light of the amendments to the claims.
Withdrawn Claim Rejections - 35 USC § 112 – Written Description
The rejection of claims under 35 U.S.C. 112, as set forth on pages 9-13 of the Office Action of 12/23/2025 is withdrawn in light of the amendments to the claims.
Withdrawn Claim Rejections - 35 USC § 102
The rejection of claims under 35 U.S.C. 102, as set forth on pages 13-14 of the Office Action of 12/23/2025 is withdrawn in light of the amendments to the claims.
Maintained Claim Rejections - 35 USC § 103
Modified/Newly Applied as Necessitated by Claim Amendments
Claim(s) 1, 5, 10 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ran et al (2020) as cited on the IDS of 07/17/2023, in view of Cohen et al (WO 2016/156440, Oct. 6, 2016).
Relevant to the limitations of the claimed methods, with regard to genotype content in a patient having been determined (claim 1), Ran et al teaches the detection of homozygous and heterozygous genotypes (i.e.: A/A; A/T; T/T) at rs1475856 in human subjects (e.g.: Table I on page 4), consonant with the election and relevant to the limitations of claims 1 and 10. Further relevant to the claims, Ran et al teaches that rs1475658 is associated with the IL-33 gene, and that T allele of rs1475856 is overrepresented in subject with allergic rhinitis (AR) (e.g.: Table I; Table II); Ran et al further teaches IL‑33 has been indicated to be an important factor driving asthma, and that the commonly observed comorbidity of asthma and AR in the clinic suggests the presence of shared genetic risk factors and biological mechanisms between these diseases (e.g.: p.1, left col). Furthermore, the teachings of Ran et al include a total of 769 patients with AR (453 men and 316 women) aged between 10 and 65 years (e.g.: p.2 – Subjects), where such a population includes subjects with an age that would be characterized as early onset asthma (e.g.: under age 18, relevant to claim 5)
Ran et al does not teach treatment of a subject suffering from asthma with an anti-IL-33 antibody or antigen binding fragment thereof comprising SEQ ID NOs: 37-42 (relevant to claim 1) or comprising SEQ ID NO: 1 and 19 (relevant to claim 50). However, the use of such antibodies in the treatment of asthma was known in the prior art and is taught by Cohen et al.
Cohen et al teaches anti IL-33 antibodies, including (e.g.: p.217) the antibody identified as 33_640087-7 which includes SEQ ID NOs: 543-545 and 548-550 of the prior art application (which are the same as SEQ ID NOs: 37-42, respectively, of the instant application, as recited in claim 1). Cohen et al teaches that the antibody functional against IL-33 binding (e.g.: Figs 45; Fig 49), and teaches that the antibody can be used in the treatment of asthma (paras 671, 686; claims 46-52 on page 246). Relevant to claim 50, Cohen et al teaches provides the antibody 33_640087-7B that includes a VH that is SEQ ID NO: 616 (identical to instantly claimed SEQ ID NO: 1) and a VL that is SEQ ID NO: 618 (identical to instantly claims SEQ ID NO: 19).
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have detected genotypes associated with AR as taught by Ran et al in a subject with asthma based on the expressed teachings of Ran et al that asthma is a typical comorbidity with AR, and based on the teachings of Ran et al that IL-33 has genotypes associated with both asthma and AR. It would have been obvious to treat asthma subject with the genotype taught by Ran using the anti-IL33 antibodies of Cohen et al based on the expressed teachings of Cohen et al that such antibodies abrogate the function of IL-33, that IL-33 is associated with the asthma phenotype (e.g.: para 5-8), and that the antibodies can be used to treat a subject with an inflammatory condition such as asthma.
Response to Remarks
Applicants have traversed the rejection of claims under 35 USC 103 as maintained above. Applicants’ arguments (p.7-9 of the Remarks of 04/22/2026) have been fully and carefully considered but are not found to be persuasive.
Applicants have argued that Ran et al (as cited in the rejection) does not render obvious the claimed methods of treating a patient with asthma because “Ran has not taught anything about the association of rsl475658 with the risk of asthma.” This argument is not persuasive because it does not take into consideration the plain teachings of Ran et al, for example:
The commonly observed comorbidity of asthma and AR in the clinic suggests the presence of shared genetic risk factors and biological mechanisms between these diseases. Interleukin (IL)‑33 has been indicated to be an important factor driving asthma susceptibility and pathogenesis using both genome‑wide association studies and functional studies in model animals.
In summary, the results of the current study suggested that certain variations in the IL‑33 gene represent a potential risk for AR, and indicated a shared genetic basis between AR and asthma.
As >80% of patients with asthma exhibit rhinitis, and 10‑40% of patients with rhinitis develop asthma, these two diseases are considered to share risk factors and mechanisms.
In this regard it is noted that a proper rejection under 35 USC 103 for obviousness does not require absolute predictability, but only a reasonable expectation of success (MPEP 2143). In the instant case the Examiner maintains that where the prior art teaches an association between genotypes consistent with the requirements of the claims (i.e.: T allele of rs1475658) and allergic rhinitis, and the typical comorbidity of allergic rhinitis and asthma, as well as similarities between allergic rhinitis and asthma with regard to inflammation related mechanisms of pathology related to IL-33, the skilled artisan would recognize that detection of the required alleles may be indicative of both the presence of asthma and the biological implication of the target of the treatments taught by Cohen et al.
Conclusion
No claim is allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN THOMAS KAPUSHOC whose telephone number is (571)272-3312. The examiner can normally be reached M-F, 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
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