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 .
Response to Amendment
Claims 13, 20 and 22 have been cancelled. Claims 1, 4, 12, 14, 18-19, and 21 have been amended as requested in the amendment filed on 17 March 2026. Following the amendment, claims 1-12, 14-19 and 21 are pending in the instant application and are under examination in the instant office action.
Withdrawn Rejections:
As currently amended to remove relative language in Claim 1 and to set forth active steps in claim 4, the rejection of Claims 1-22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
As currently amended to remove reference to functional variants and to define diseases associated with IL-18, respectively, the rejection of Claims 12 and 21 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn.
The Terminal Disclaimer filed on 17 March 2026 and Approved on 30 March 2026 has overcome the rejection of Claims 1-2, 4, 7, and 9-19 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,858,426 issued 8 December 2020.
The Terminal Disclaimer filed on 17 March 2026 and Approved on 30 March 2026 has overcome the rejection of Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No.11,530,263 issued 20 December 2020.
Claim Rejections - 35 USC § 112 (Maintained)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
As currently amended, Claims 1-12, 14-19 and 21 stand as rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, scope of enablement, for reasons of record in the previous Office action. Briefly, while being enabling for treatment of COPD or an IL-18-associated disease or disorder induced by smoking or second-hand smoke exposure (currently added to Claim 21), comprising administering the IL-18BP of SEQ ID NO:7 (specification pg. 83, at (B); and Figure 5); the specification does not reasonably provide enablement for reducing the level of free IL-18 comprising administering any other IL-18 binding protein other than SEQ ID NO:7, nor for treating any other disease listed in amended claim 21 other than COPD and smoking or second hand smoke-related diseases.
On pages 7-9 of Remarks filed 17 March 2026, Applicant traverses the rejection on the following grounds. Applicant asserts that as amended claim 1 limits the element to inhibiting/neutralizing free IL-18 comprising administering an IL-18 binding protein. Applicant asserts the specification, at least in Example B at paragraphs [00372]-[00379], demonstrates that administration of IL-18BP can inhibit/neutralize IL-18 in a tobacco smoke mouse model system. Specifically, mouse IL-18 was expressed under smoke exposure and administration of IL-18BP to the mouse results in significant mitigation of total cell infiltration in the lung (see, e.g., paragraph [00376]), inhibition of neutrophil infiltration in the lungs (see, e.g., paragraph [00377]), inhibition of release of G-CSF in the lung airways (see, e.g., paragraph [00378]), and alleviation of weight loss due to exposure to tobacco smoke and p[I:C] (see, e.g., paragraph [00379]). As each of the results is due to the presence of free-IL-18 in the mouse upon exposure to tobacco smoke, Applicant notes that administration of IL-18BP inhibited/neutralized the free IL-18 in the mouse. Thus, as the claims only required inhibiting/neutralizing free IL-18 in a subject by administering an IL-18 binding protein to the subject, claim 1 meets the enablement requirement since a person skilled in the art could make and use the invention according to claim 1 without undue experimentation based on the disclosure and the knowledge in the art.
While these arguments have been considered in full they are not persuasive to overcome the rejection of record for the following reasons. First, the scope of an IL-18 binding protein (IL-18BP) that inhibits/neutralizes free IL-18 encompasses any protein that binds IL-18 including antibodies and aptamers. In contrast to the breadth of the claims, the specification has provided enabling guidance only for the specific IL-18BP of SEQ ID NO: 7. Absent specific guidance within the disclosure a person having ordinary skill would have to perform further experimentation in order to make the IL-18BP antibodies/aptamers that are encompassed by the claim, and this amount of further experimentation goes beyond what is considered routine in the art, and constitutes undue further experimentation in order to make the elements of the invention commensurate in scope with the breadth of the claims.
Secondly, as stated by Applicant in Remarks, the examples pertain to COPD or tobacco animal models. Specifically, administration of the IL-18BP of SEQ ID NO: 7 leads to inhibition of neutrophil infiltration in the lung airway space, inhibition of G-CSF, and mitigated weight loss in this COPD animal model (pg. 83 at B and pg. 85). In contrast, the claims encompass a vast array of diseases and disorders. Amended claim 21 includes transfusion-related lung injury, bronchopulmonary dysplasia (BPD), acute respiratory distress syndrome (ARDS), Adult Still's disease, juvenile Still's disease, interstitial lung disease (ILD), idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, asthma, bronchiectasis, heart failure, amyotrophic lateral sclerosis (ALS), dry eye disease (DED), keratitis, corneal ulcer and abrasion, corneal neovascularization, pathological intraocular neovascularization, iritis, glaucoma, macular degeneration, Sjogren's syndrome, autoimmune uveitis, Behget's disease, conjunctivitis, allergic conjunctivitis, dermatitis of eyelid, diabetes type 2, non-alcoholic fatty liver disease (NAFLD), steato hepatitis, solid organ and hematologic transplantation, ischemia reperfusion injury, familial Mediterranean fever, tumor necrosis factor receptor 1-associated periodic syndromes, cryopyrin- associated periodic fever syndromes, hyper-IgD syndromes, gout, Schnitzler syndrome, Wegener's granulomatosis also called granulomatosis with polyangitis (GPA), Hashimoto's thyroiditis, Crohn's disease, ulcerative colitis, immunoglobulin-4 (IgG4)-related diseases and stem cell therapies, viral infection, or is an IL-18 induced systemic manifestation of inflammation and associated comorbidities. Most of these disorders have no clear nexus between their etiology and the working examples provided in the disclosure. For example, Example B of the specification, directed to “a tobacco smoke mouse model system” (as stated in Remarks) is not predictive of treating i.e. non-alcoholic fatty liver disease (NAFLD) of the instant claim. Nor is the tobacco model predictive of treating any of the other diseases/disorders listed in amended claim 21. There is no guidance or direction for how inhibiting/neutralizing IL-18 would lead to treating any of these listed diseases with reasonable success. Absent guidance within the disclosure as filed, a person having ordinary skill in the art could not use the claimed method, commensurate in scope with the breadth of the claims, without first making a substantial inventive contribution. Given that the nature of the invention is in vivo treatment, a person having ordinary skill in the art would have to perform multiple further experiments, in either human clinical trials or in animal models that are predictive of treating the diseases listed within claim 21, in order to demonstrate use of the invention with a reasonable expectation of success. This amount of experimentation that would be required for enabling guidance, goes beyond what is considered ‘routine’ within the art, and constitutes undue further experimentation in order to make other IL-18BPs and use those with a reasonable expectation of successfully treating any “IL-18 associated disease or disorder”.
Therefore, Claims 1-12, 14-19 and 21 stand as rejected under 35 U.S.C. 112, first paragraph, for failing to meet the enablement requirement.
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.
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/STACEY N MACFARLANE/Examiner, Art Unit 1675
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