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 the Application
Claims 1, 11-13, and 20-34 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 12/18/2025 are acknowledged. Claims 1, 11, 22-23, and 29-34 remain withdrawn, as being drawn to an unelected invention or specie. Claim 12 is amended and new claims 20-34 are added. Claims under consideration in the instant office action are claims 12-13, 20-21, and 24-28.
Applicants' arguments, filed 12/18/2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Election/Restrictions
Newly submitted claims 22-23 and 29-34 do not read on the elected species and are withdrawn.
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.
Claims 12-13, 20-21, and 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Taveras et al. (WO 03/080053, as disclosed in IDS) in view of Adcock (Molecular Mechanisms of Corticosteroid Resistance, Chest, 2008, 134(2), pp. 394-401) and Colella et al. (1,3-Dibromo-1,1-difluoro-2-propanone as a Useful Synthon for a Chemoselective Preparation of 4‑Bromodifluoromethyl Thiazoles, ACS Omega, 2018, 3, pp. 14841-14848).
Taveras et al. teaches methods of treating chemokine-mediated diseases, including asthma, comprising the administration of combinations comprising CXC-chemokine receptor antagonists with other classes of pharmaceutical compounds (see abstract). Taveras et al. teaches such combinations comprising a steroid such as dexamethasone (pg. 3, lines 4-20). Taveras et al. teaches “The CXC-chemokines include interleukin-8 (IL-8), neutrophil-activating protein-1 (NAP-1 ), neutrophil-activating protein-2 (NAP-2), GROa, GROj3, GROy, ENA-78, GCP-2, IP-10, MIG and PF4. CC chemokines include RANTES, MIP -1a, MIP-213, monocyte chemotactic protein-1 (MCP-1 ), MCP-2, MCP-3 and eotaxin. Individual members of the chemokine families are known to be bound by at least one chemokine receptor, with CXC-chemokines generally bound by members of the CXCR class of receptors, and CC-chemokines by members of the CCR class of receptors. For example, IL-8 is bound by the CXCR-1 and CXCR-2 receptors.” (pg. 1, lines 12-25).
Taveras et al. does not teach a method of treating corticosteroid-resistant asthma. Taveras et al. does not teach a combination comprising DF2755.
Adcock is drawn towards mechanisms of corticosteroid resistance, particularly in asthma patients (see abstract). Adcock teaches GC-resistant or corticosteroid-refractory (CSR) asthma is defined as < 15% improvement in baseline FEV, after a 14-day course of oral prednisolone (40 mg/d) in patients who demonstrate > 15% improvement in FEV, with salbutamol therapy.” (pg. 395, left column, second paragraph). Adcock teaches “the multiple mechanisms underlying CSR asthma may indicate the need for patient-specific treatment with novel therapies directed at abnormal signaling pathways to restore asthma control' (Table 1).” (pg. 399, left column, third paragraph). Adcock teaches that combination therapies may be effective for patients with CSR asthma (pg. 399, right column, first paragraph).
Colella is drawn towards the use of 1,3-dibromo-1,1-difluoro-2-propanone as a synthon for drug discovery (see abstract). Colella teaches “our recent efforts focused on (2S)-2-(4-{[4-(trifluoromethyl)-1,3-thiazol-2-yl]- amino}phenyl)propanoic acid (DF2755Y) (Scheme 1), a small molecule belonging to a novel allosteric dual CXCR1/CXCR2 inhibitor with a favorable oral pharmacokinetic profile. This molecule selectively inhibited neutrophil chemotaxis induced by CXCR1/2 ligands without affecting on CXCL8 binding to these receptors. The activation of CXCR1/2 has been implicated in the genesis of inflammatory and postoperative pain and progression of severe chronic diseases, including rheumatoid arthritis, chronic obstructive pulmonary disease, Alzheimer’s disease, melanoma, and several urological diseases.” (pg. 14841, Introduction).
It would have been obvious to one of ordinary skill in the art to treat corticosteroid-resistant asthma, as suggested by Adcock, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since Taveras et al. teaches combinations comprising CXC-chemokine receptor antagonists with other classes of pharmaceutical compounds as effective for the treatment of asthma, and Adcock suggests the use of combination therapies for the treatment of CSR asthma, with a reasonable expectation of success absent evidence of criticality of the particular steps.
It would have been obvious to one of ordinary skill in the art to further administer compound DF2755, as suggested by Colella et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since Colella et al. teaches DF2755Y as an effective CXCR1/CXCR2 inhibitor, and Taveras et al. teaches combinations comprising chemokine antagonists and other pharmaceutical compounds for the treatment of asthma. Thus, one of ordinary skill in the art would have been motivated to do so since it is prima facie obvious to combine components known for the same purpose for their combined additive effects, with a reasonable expectation of success absent evidence of criticality of the particular formulation. Additionally, “[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Therefore, it would have been prima facie obvious to combine dexamethasone and DF2755 in composition cojointly to treat CSR asthma.
Regarding claim 20, when the composition recitations are met, the desired properties are met, as any component that materially affects the composition and its properties would have to be present in the claim to be commensurate in scope (i.e. claim 20). Additionally, when the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as the therapeutic profile, as they are a direct result of the components of the composition and the mode of administration which are met by the art, whereby the resulting properties and effects would intrinsically be met. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.
Response to Arguments
Applicant argues that “No combination of clarithromycin is disclosed with any other active agent, not to mention a corticosteroid. This is consistent with the fact that the conditions of focus in the Adcock reference are characterized by corticosteroid resistance, and so there would not have been any motivation to combine any treatment of Adcock with corticosteroids, in particular. Therefore, the only cited reference relating to the same disease specified in the present claims does not provide any teaching regarding the administration of IL-8 inhibitors in combination with any other active agent, not to mention a corticosteroid.” The Examiner respectfully disagrees since Adcock does teach that combination therapies may be effective for patients with CSR asthma (pg. 399, right column, first paragraph). Taveras et al. teaches methods of treating chemokine-mediated diseases, including asthma, comprising the administration of combinations comprising CXC-chemokine receptor antagonists, including IL-8 inhibitors, with other classes of pharmaceutical compounds (see abstract; pg. 1, lines 12-25). Taveras et al. teaches such combinations comprising a steroid such as dexamethasone (pg. 3, lines 4-20). One of ordinary skill in the art would thus be motivated to administer combinations comprising an IL-8 inhibitor for the treatment of asthma, with a reasonable expectation of success absent evidence of criticality of the particular steps.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant also argues that “Colella teaches a process for the production of ladarixin, and in the list of diseases cited the Examiner, and reported in the Background section of Colella, there is no mention of asthma or corticosteroidresistant asthma (indeed, the listed diseases are "rheumatoid arthritis, chronic obstructive pulmonary disease, Alzheimer's disease, melanoma, and several urological diseases'). Therefore, not even this reference relates to the disease treated in the presently claimed invention, similar to Taveras.” The Examiner respectfully disagrees since although Colella does not specifically disclose asthma, Colella is drawn towards a compound DF2755Y as a dual CXCR1/CXCR2 inhibitor (Scheme 1), which provides a sufficient nexus to the teachings of Taveras et al. , which is drawn towards methods of treating chemokine-mediated diseases, including asthma, comprising the administration of combinations comprising CXC-chemokine receptor antagonists with other classes of pharmaceutical compounds (see abstract).
Conclusion
Claims 12-13, 20-21, and 24-28 are rejected.
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 ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691