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 .
Claim Status
Claims 1-3, 8-11, 18, 21-22, 25, and 28 are under consideration in this office action.
Withdrawn Objections/Rejections
Any objection or rejection of record pertaining to cancelled claims 12-17 and 26 is rendered moot by applicant’s cancellation of said claims.
The objections of claims 1, 3, 9, 11, 14-15, and 22 are withdrawn in view of applicant’s amendment.
The rejection of claims 22 and 25 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of applicant’s amendment.
The rejection of claims 1-3, 8-11, 18, 21-22, 25, and 28 under 35 U.S.C. 112(a) as failing to comply with the written description is withdrawn in view of applicant’s amendment to specifically identify the six CDRs of the anti-CD131 antibody in claim 1.
The rejection of claims 1, 9-11, 18, 21, and 28 under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by US 20170252436 (“Diluzio”) is withdrawn in view of applicant’s amendment of claim 1 to limit the anti-CD131 antibody to a specific antibody.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
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 11, 18, and 21 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.
The functional limitations of claims 11, 18, and 21 are inherent properties of the one embodiment of claim 1 (i.e. the anti-CD131 of antibody of HCDR1-3 of SEQ ID NOs: 8-10 and LCDR1-3 of SEQ ID NOs: 11-13), and thus the limitations are not further limiting. The product is merely functioning as intended.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
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.
Claims 1-2, 8-11, 18, 21-22, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190062438 A1, published February 28, 2019 (“Owczarek”; PTO-892 from 12/15/2025) in view of US 20170252436, published September 7, 2017 (“Diluzio”; PTO-892 from 12/15/2025).
The claims are directed to a method of treating or preventing ARDS in a subject by administering an anti-CD131 antibody comprised of HCDR1-3 of SEQ ID NOs: 8-10 and LCDR1-3 of SEQ ID NOs: 11-13.
Owczarek teaches an anti-CD131 antibody that neutralizes signaling by IL-3, IL-5 and GM-CSF (abstract; [0008]), as in the compound that binds to CD131 of instant claim 1. In embodiment (cxvii), the VH comprises CDRs 1, 2, and 3 of the sequence of SEQ ID NO: 64 and a VL comprising CDR1 1, 2, and 3 of the sequence of SEQ ID NO: 5 [0226]. SEQ ID NO: 64 of Owczarek is comprised of instant SEQ ID NOs: 8-10 and SEQ ID NO: 5 of Owczarek is comprised of instant SEQ ID NOs: 11-13, as in the anti-CD131 antibody of instant claims 1, 11, 18, and 21.
The anti-CD131 antibody of Owczarek may be used in a method of treating or preventing a condition caused by exacerbated CD131 signaling [1143], including interstitial lung disease [1145], respiratory condition [1149], and chronic eosinophilic pneumonia, as in the infection of instant claim 2 and the interstitial pneumonia or instant claim 8.
Owczarek teaches a CD131 binding protein that inhibits GM-CSF-induced proliferation of TF01 cells with an IC50 of at least 100 nM [0013], as in instant claim 11. This anti-CD131 antibody of Owczarek is comprised of a VH/VL pair of SEQ ID NO: 64/SEQ ID NO: 5, which are comprised of VH/VL pair of instant SEQ ID NO: 6/18 and the CDRs therein of claim 22. Claim 22, subpart c is directed to a heavy chain comprising SEQ ID NO: 8 and a light chain comprising SEQ ID NO: 9. It is noted that SEQ ID NO: 8 and SEQ ID NO: 9 correspond to CDR1 and CDR2, respectively, of VH of SEQ ID NO: 64 of Owczarek.
The CD131 antibodies of Owczarek bind an epitope within a region of CD131 designated as “site 2” [0008], as required by instant claim 18. Owczarek also teaches an anti-CD131 antibody that bind domain 1 and domain 4 of CD131 [0019], including an epitope comprising amino acid 103 of SEQ ID NO: 1 [0020], as required by instant claim 21.
Owczarek does not explicitly teach a method for preventing or treating ARDS.
Diluzio teaches inhibitors of the GM-CSF receptor, including antibodies directed to GM-CSF alpha chain and CD131, which is the GM-CSF/IL-3/IL-5 common beta chain [0120].
The inhibitors of GM-CSF receptor can be used to treat or prevent disease in patients in need; the patients in need of treatment may be suffering from acute respiratory distress syndrome [0219], as in instant claims 1 and 28.
Given that Owczarek teaches the anti-CD131 antibody of claim 1 in a method of treating respiratory condition and further given that Diluzio teaches a method of treating and preventing ARDS by administering an antibody that binds the beta domain of a receptor for GM-CSF (i.e. CD131), one of ordinary skill in the art would have been able to reasonably predict the efficacy of the antibody of Owczarek in the treatment of ARDS associated with infection or ARDS in a subject with interstitial pneumonia, especially in view of the demonstrated efficacy of the Owczarek antibody in the treatment of disease associated with exacerbated CD131 signaling. This is because the ordinary artisan has good reason to pursue known options within their technical grasp to obtain predictable results (MPEP2143.B). Such would amount to the simple substitution of one functionally equivalent element for another (i.e. the antibody of Owczarek for that of Diluzio) to obtain predictable results in the treatment of ARDS. The motivation to do so comes from both Diluzio [0021] and Owczarek ([1137]-[1138], [1143]), which teaches the potential clinical benefit compounds targeting CD131 for the treatment of inflammation and infection in respiratory conditions.
Although the references are silent regarding the limitations of claims 9-11 and 18 relating to decreased amounts of neutrophils and monocytes in blood; decreased neutrophils, macrophages, inflammation, oedema, and NETosis in lung; decreased myeloperoxidase activity, protein, and dsDNA in the bronchoalveolar fluid of the lung; decreased lung injury score (as in claim 9); prevention of a decrease in percentage in blood oxygenation (as in claim 10); inhibition of related GM-CSF/IL-5/IL-3 proliferation of TF-1 cells with an IC50 of at least 100 nM (as in claim 11); and a protein that binds to the epitopes of CD131 of claims 18 and 21, it is clear that the same method comprising administration of the same product directed to the same subject population would have the same characteristics as the instantly claimed method, since there is no evidence to the contrary. The limitations of these claims are statements of phenomena that necessarily occur after the administration step. Applicants are reminded that chemical compounds and their properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)).
Claims 1-3, 8-11, 18, 21-22, 25, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190062438 A1, published February 28, 2019 (“Owczarek”) in view of US 20170252436, published September 7, 2017 (“Diluzio”), as applied to claims 1-2, 8-11, 18, 21-22, and 28 above, and further in view of De Luca et al, published August 2020 (PTO-892 from 12/15/2025).
The teachings of Owczarek in view of Diluzio are discussed above; Owczarek in view of Diluzio does not teach in a method of treating ARDS in a subject infected with coronavirus or SARS-Cov-2, as required by claim 3, or the combination therapy of claim 25.
De Luca et al teaches a method for treating SARS-CoV-2 in a patient with the anti-GM-CSF receptor-alpha monoclonal antibody mavrilimumab (abstract), as in instant claim 3. Citing an earlier study, De Luca teaches that of 201 patients admitted to hospital with COVID-19, 42% developed acute respiratory distress syndrome and 52% of these patients died, demonstrating that ARDS is a complication of SARS-CoV-2 infection and the need for effective treatment to prevent escalation to a critical stage (pg 3466, “Research in context”).
De Luca teaches that the mavrilimumab therapy is administered in combination with standard management (abstract), including mechanical ventilation (figure 2) and antibiotic treatment (e471, column 2), as in claim 25.
Given that Owczarek in view of Diluzio teach a method of treating ARDS by administering an anti-GM-CSF-R antibody that targets beta subunit CD131 and alpha subunit CD116, and further given that De Luca teaches a method of treating ARDS related to SARS-CoV-2 infection by administering an anti-GM-CSF-R alpha subunit antibody, one of ordinary skill in the art would have been able to reasonably predict the efficacy of the antibody of Diluzio in view of Owczarek in the treatment of ARDS associated with SARS-CoV-2, especially in view of the demonstrated efficacy of the antibody of De Luca (which only targets GM-CSF-R signaling) in the treatment of ARDS. Because De Luca teaches that inhibiting GM-CSF signaling by blocking its receptor is useful to treating SARS-CoV-2 related ARDS, one of ordinary skill in the art would appreciate that another blocker of GM-CSF signaling that targets the other domain of the receptor would also be efficacious in the treating the disease. This is because the ordinary artisan has good reason to pursue known options within their technical grasp to obtain predictable results (MPEP2143.B). Such would amount to the simple substitution of one functionally equivalent element for another (i.e. the antibody of Diluzio in view Owczarek for that of De Luca) to obtain predictable results. The motivation to do so comes from both De Luca, which teaches the successful treatment of SARS-CoV-2 with an antibody that targets GM-CSF receptors (abstract).
Response to Arguments
Applicant's arguments filed March 16, 2026 regarding the rejection under 35 U.S.C. 103 have been fully considered.
In view of applicant’s amendment, the rejection has been modified with Owczarek as the primary reference. As such, applicant’s arguments regarding Diluzio not teaching specific anti-CD131 antibodies (remarks, pg 13) and lack of motivation to use the antibody of Owczarek in the method of Diluzio are considered moot.
Applicant asserts that Owczarek teaches anti-CD131 antibodies capable of neutralizing IL-3, IL-5, and GM-CSF signaling but does not teach or suggest the use of these antibodies to treat or prevent ARDS (remarks, pg 14). As detailed in the rejection above, Diluzio remedies this deficiency. Even if the examiner concedes that Diluzio does not teach an anti-CD131 antibody and that this embodiment is only mentioned in passing, which the examiner does not, the examiner maintains their position that Diluzio teaches the genus anti-GM-CSF receptor antibodies for the treatment of ARDS, and that it would be obvious to use the species of anti-CD131 antibody as claimed. See MPEP 2141.III: “Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art.” Here, one looking to use an antibody to inhibit GM-CSF receptor signaling for the treatment of ARDS would use the antibody of Owczarek and have a reasonable expectation of success. Absolute predictability is not a necessary prerequisite to a case of obviousness. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient. “Good science and useful contributions do not necessarily result in patentability.” PharmaStem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342 (Fed. Cir. 2007).
Arguments related to the Diluzio and De Luca et al not mentioning IL-3 and IL-5 or discussing signaling through CD131 are not persuasive for nonobviousness. One of ordinary skill in the art at the time the application was filed would appreciate that GM-CSF receptor is comprised of two chains (alpha and beta, i.e. CD131) and that formation of this complex is required for function (see Diluzio [0120]). Because inhibitors of either chain are known to inhibit receptor function (as disclosed by Owczarek and Diluzio), it would be obvious to the ordinary artisan that demonstrated utility of an inhibitor of one chain (i.e. the antibody of Diluzio or De Luca) would extend to an inhibitor of the other chain (i.e. the anti-CD131 antibody of Owczarek), because these inhibitors are functional equivalents. Such amounts to the simple substitution of one known element for another to obtain predictable results (MPEP 2143.I).
Notably, a new function can support a method of use claim only if it leads to a new and nonobvious use. However, because the prior art teaches a method of administering the product in the same way and the same disease, the claimed method is not novel. The teachings of Diluzio and De Luca provide the motivation that would have led one of ordinary skill to modify the Owczarek antibody and method to arrive at the claimed invention. The rejections under 35 U.S.C. 103 are maintained.
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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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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