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 .
Priority
This application, filed 12/12/2022 is a National Stage entry of PCT/AU2021/050605, International Filing Date: 06/11/2021. PCT/AU2021/050605 claims foreign priority to 2020901933, filed 06/11/2020. A certified copy of the foreign priority application is of record.
Status of Claims
Claims 43-67 are pending as of the response filed on 12/10/25.
Applicant’s election without traverse of invention I, claims 63-67; the species ursodeoxycholic acid of formula (I), and probucol as the species of active ingredient in the reply filed on 12/10/25 is acknowledged.
Claims 43-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/25.
Claims 63-67 were examined and are rejected.
New Title Required
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Rejections-35 USC § 102
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.
Claim(s) 63-65 and 67 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Mooranian et. al., Pharm. Dev. & Tech., 24(10), (2019), 1272-1277 (cited in an IDS).
Mooranian discloses probucol as an anti-atherosclerotic drug, and the anti-inflammatory effects of this drug were optimized by combination with the anti-inflammatory bile acid, ursodeoxycholic acid (UDCA) in the form of microcapsules (title & abstract; p. 1272, beginning with 2nd para-p. 1273, left col., top para). Mooranian further discloses probucol was present at a concentration of 10 mg/mL for the preparation of the microcapsules (p. 1273, left col., see para under Materials & reagents), which corresponds to 1 wt%. Mooranian discloses the microcapsule composition composed of probucol and UDCA resulted in improved tissue absorption and reduced inflammation (abstract).
Regarding the recitations in claims 63-65 and 67, “wherein the formulation is formulated to be administered to the middle or inner ear”, “wherein the formulation is formulated to be administered to the middle or inner ear by the transtympanic route”, and “wherein the formulation is formulated to be administered to the middle or inner ear by the transtympanic route”, these statements are interpreted as being drawn to intended use of the claimed formulation. If statements of intended use don’t impart structural limitations to the claimed formulation, they are not considered to further distinguish the formulation from the prior art. See MPEP 2111.02(II): If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"). As the body of claims 63-65 and 67 fully set forth the structural limitations of the claimed formulation, the statements of intended use don’t impart further structural limitations to the claims, and the claims are not distinct from the composition disclosed by Mooranian. Mooranian therefore anticipates the claims.
Claim(s) 63-64 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mohsen Al-mahallawi et. al., Int. J. Pharmaceutics, 472, (2014), 304-314.
Although an election of species has been made, this rejection is made over the broader claim scope to provide compact prosecution.
Mohsen Al-mahallawi discloses the preparation of nano-transfersomal ciprofloxacin loaded vesicles for non-invasive trans-tympanic ototopical delivery (title & abstract; pp. 305-306, para 2.2.1). Ciprofloxacin is a known synthetic fluoroquinolone antibiotic used for the treatment of otitis media and otorrhea, and transtympanic formulations for this antibiotic are desirable (abstract). Mohsen Al-mahallawi discloses a composition comprising ciprofloxacin entrapped within transfersomes comprising sodium deoxycholate (p. 305, see last formulation in Table 1). Sodium deoxycholate is included within formula (I), having R2 and R5=GL, wherein G is O and L is H; R3, R4, R7, R8, R9, and R10=H; R6=-(CH2)n-, wherein n=1; and R1=GL, wherein G is absent and L is a sodium ion. Mohsen Al-mahallawi therefore anticipates the claims.
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.
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.
Claim(s) 66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mooranian et. al., Pharm. Dev. & Tech., 24(10), (2019), 1272-1277, as applied to claims 63-65 and 67 as discussed previously, in view of Mooranian et. al., Therapeut. Del., 9(11), (2018), 811-821 (cited in an IDS, hereafter referred to as Mooranian 2).
The disclosure and teachings of Mooranian as discussed previously are incorporated herein. Mooranian doesn’t explicitly teach or suggest the inclusion of deoxycholic acid in the composition.
Mooranian 2 teaches probucol as a very hydrophobic drug having both antidiabetic and anti-inflammatory effects (abstract; p. 812, para before Materials & methods). Mooranian further teaches probucol microcapsules, wherein the microcapsules are composed of the permeation enhancer, deoxycholic acid (DCA), exhibited good stability and significant release of probucol (p. 811, last 3 lines-p. 812, top para; p. 815, para).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have modified the probucol microcapsule formulation disclosed by Mooranian by further incorporating DCA, in consideration of the combined teachings of Mooranian and Mooranian 2. Ursodeoxycholic acid and DCA are both taught as permeation enhancers that improve pharmacokinetic properties of probucol in microcapsule form. Therefore, it would have been prima facie obvious to have incorporated both permeation enhancers, deoxycholic acid and UDCA, into the microcapsule composition comprising probucol, and have had a reasonable expectation that the pharmacokinetic characteristics of probucol would have been further enhanced.
Information Disclosure Statements
The IDS filed on 7/17/23 and 10/24/24 have been considered.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627