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 .
DETAILED ACTION
This office action is in response to applicant’s reply filed on April 22, 2026.
Restrictions/Elections.
Applicant election of the following species: COPD, as the condition requiring an anti-inflammatory agent, is acknowledged.
Since the above species is free of prior art, the examination was expanded to melanoma cancer.
Status of Claims
Claims 9-18 are currently pending and are the subject of this office action.
The elected species (COPD) s encompassed by claims 9-18.
The expanded species (melanoma) is encompassed by claims 9-17.
The combined set of claims that reads on one or both species, and as a consequence are under examination, are claims 9-18.
Priority
The present application is a 371 of PCT/EP2022/25336 filed on 07/20/2022 and claims priority to foreign application ITALY IT102021000019355 filed on 07/21/2021.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
1) Claim(s) 9-10 and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Banciu et. al. (Journal of Steroid Biochemistry and Molecular Biology (2008) 111:101-110, cited by Applicant).
For claim 9, Banciu teaches (see section 2.6) a method of treating melanoma (a condition requiring an anti-inflammatory agent, see discussion below) comprising the administration to mice suffering from melanoma (see section 2.3) a composition comprising an effective amount of BUP (Budesonide 21-phosphate disodium salt).
The authors conclude: “The differences in antitumor activity correlate with their inhibitory activity towards the production of pro-angiogenic/pro-inflammatory factors involved in tumor angiogenesis and inflammation, among the four GC (Glucocorticoid) compounds studies, BUP show the highest antitumor activity, which is likely related to the strong potency of this GC to reduce the production of pro-angiogenic and pro-inflammatory factors in tumors” (see page 109, left column, last paragraph). This means that BUP is considered an anti-inflammatory agent and melanoma is, therefore, a condition requiring an anti-inflammatory agent (BUP).
For claim 10, Banciu teaches that the BUP compound was formulated in long-circulated liposomes (LCL, which is considered a physiologically acceptable excipient) (see abstract and entire document and in particular section 2.1).
For claims 14-15, Banciu teaches that the formulation was administered intravenously (i.e. parenteral route, see section 2.6, second paragraph).
2) Claim(s) 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Banciu et. al. (Journal of Steroid Biochemistry and Molecular Biology (2008) 111:101-110, cited by Applicant) as evidenced by Ben Neriah et. al. (WO 2005/123772, 12/29/2005)
Melanoma is considered a chronic inflammatory disease as evidenced by Ben Neriah (see page 4, line 19 from the top)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1) Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banciu et. al. (Journal of Steroid Biochemistry and Molecular Biology (2008) 111:101-110, cited by Applicant) in view of Hu et. al. (US 6,482,802).
Banciu teaches all the limitations of claims 11-12 (see 102(a)(1) above), except for the co-administration of an antibiotic. However, Hu teaches a method of treating angiogenic-related diseases comprising the administration of the antibiotic neomycin (see title for example), wherein the angiogenic related disease can be cancer (see column 16, last line), and more specifically melanoma (see column 17, line 23).
Before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to treat melanoma combining two compositions (BUP and the antibiotic neomycin) each of which is taught by the prior art to be useful for the same purpose (treating melanoma), in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art (see MPEP 2144.06). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See also: Inre Diamond, 360 F.2d 214, 53 C.C.P.A. 1172, 149 U.S.P.Q. 562 (C.C.P.A. 1966).
All this would result in the practice of claims 11-12 with a reasonable expectation of success.
Regarding claim 13, the prior art is silent regarding the sequence of administration. However, there are only three possible options: 1-simultaneous administration, 2- separate administration and 3- sequential administration, thus resulting in the practice of claim 13 with a reasonable expectation of success.
2) Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banciu et. al. (Journal of Steroid Biochemistry and Molecular Biology (2008) 111:101-110, cited by Applicant).
Banciu teaches all the limitations of claim 16 (see above 102(a)(1) rejection), except for the composition being a metered dose inhalation aerosol formulated as a suspension or solution. However, aerosol formulations are standard practice in the pharmaceutical art, thus resulting in the practice of claim 16 with a reasonable expectation of success.
Claim Objections
Claim 18 is objected to in part as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and to recite only the elected species (COPD).
Note that claim 19 is objected to in part herein insofar as it contains non-elected subject matter to which the prior art search has not yet been extended. That part which has been searched, however (consistent with the election of species requirement as previously discussed), would be allowable if the claim was amended in independent form including all the limitations of the base claim and any intervening claims, and to remove the currently non-elected subject matter (i.e. all the species except for COPD).
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
April 23. 2026.
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