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 Claims
Claims 43-80 are pending as of the response and amendments filed on 7/27/26. Claims 1-42 were previously canceled and claims 68-80 have been newly added. Claims 43-62 are withdrawn from examination, being directed to a non-elected invention. Claims 63-80 are currently under examination.
The objection to the title is withdrawn in view of the title amendment.
The 102 rejections of record over Mooranian, and Al-mahallawi; and the 103 rejection over Mooranian in view of Mooranian 2 are withdrawn in consideration of the amendments.
Based on the amended and new claims, new rejections under 35 USC 103 and 112(b) are made, detailed below.
Claims 63-80 were examined. Claims 63-75, 77, and 79 are rejected. Claims 76, 78, and 80 are objected to.
Claim Rejections-35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 73 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 73 contains the trademark/trade name “Tween 80”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the product and, accordingly, the identification/description is indefinite. To overcome this rejection, it is suggested “Tween 80” be removed from the claim.
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) 63-65, 68, and 70-75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et. al., US 20040161407 A1, publ. 8/19/2004.
Kimura teaches medicinal compositions comprising a pharmacologically active substance, a drug absorbefacient, and a taurine compound or polyamine (title & abstract; para [0009-0011]). Kimura includes probucol as a pharmacologically active substance (para [0012], [0025], [0054-0055]). Kimura exemplifies bile acids and metal salts thereof as drug absorbefacients (para [0013]), including deoxycholic acid, chenodeoxycholic acid, taurodeoxycholic acid (para [0115]). Kimura teaches the pharmacologically active substance to be present in the composition in an amount of 0.01-1000 wt %, and more particularly preferably 0.1-100 wt% (para [0129]). Kimura teaches the inclusion of additional absorbefacients such as cyclodextrins (para [0058]), including hydroxypropyl-β-cyclodextrin (para [0063], [0119]). Kimura teaches the compositions in a variety of dosage forms, including liquids and solutions (para [0134], [0190], [0225]). Kimura further teaches the composition to include surfactants such as polysorbate 80 (para [0062]).
Therefore, one of ordinary skill in the art, before the effective filing date of the claims would have arrived at the instantly claimed composition comprising probucol; an amphiphilic compound of formula (I), such as deoxycholic acid; and a cyclodextrin, such as 2-hydroxy-β-cyclodextrin, based on the teachings of Kimura as described above. Kimura teaches compositions comprising an active agent such as probucol; and absorbefacient such as deoxycholic acid and a cyclodextrin, as such, one of ordinary skill in the art would have had a reasonable expectation of success in arriving at the instantly claimed composition.
Regarding instant claim 64, wherein the formulation is formulated “to be administered to the middle or inner ear by the transtympanic route”, this recitation is drawn to intended use of the composition. If statements of intended use don’t provide structural limitations to the claim, they are not considered pertinent to the claim limitations. 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). As Kimura teaches the same ingredients in the composition as claimed, the statement of intended use “to be administered to the middle or inner ear by the transtympanic route” doesn’t appear to impart further structural components, and as such doesn’t distinguish the instantly claimed composition from Kimura.
Claim(s) 66-67, 77, and 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et. al., US 20040161407 A1, as applied to claims 63-65, 68, and 70-75 as discussed previously, further in view of Chen et. al., US 20030077297 A1, publ. 4/24/2003.
The teachings of Kimura as discussed previously are incorporated herein. However, Kimura doesn’t explicitly teach ursodeoxycholic acid as a bile acid for inclusion in the composition.
Chen teaches pharmaceutical compositions (abstract), and teaches suitable bile acids as absorbefacients to include ursodeoxycholic acid along with deoxycholic acid (para [0287]).
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 further incorporated ursodeoxycholic acid as an absorbefacient into the composition of Kimura, in consideration of the teachings of Chen. Kimura teaches compositions comprising an active agent such as probucol; and absorbefacient such as deoxycholic acid and a cyclodextrin, while Chen teaches deoxycholic acid and ursodeoxycholic acid as suitable absorbefacients for pharmaceutical compositions. As such, one of ordinary skill in the art would have further incorporated ursodeoxycholic acid into the composition of Kimura, and have had a reasonable expectation of success.
Regarding instant claim 67, wherein the formulation is formulated “to be administered to the middle or inner ear by the transtympanic route”, this recitation is drawn to intended use of the composition. If statements of intended use don’t provide structural limitations to the claim, they are not considered pertinent to the claim limitations. 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). As the structural components of the instantly claimed composition are met by the combined teachings of Kimura and Chen, the statement of intended use “to be administered to the middle or inner ear by the transtympanic route” doesn’t structurally further limit the claim and doesn’t distinguish the claimed composition from the combination of Kimura and Chen.
Claim(s) 69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et. al., US 20040161407 A1, as applied to claims 63-65, 68, and 70-75 as discussed previously, further in view of Colle et. al., Mitochondrion, vol. 13, pp. 125-133, publ. 2013.
The teachings of Kimura as discussed previously are incorporated herein. However, Kimura doesn’t explicitly teach succinobucol for inclusion in the composition.
Colle teaches probucol as a phenolic compound with antioxidant, anti-inflammatory, and hypocholesterolemic actions, however, it can cause side effects such as lowering of HDL cholesterol and prolongation of cardiac repolarization (p. 125, right col., last para-p. 126, left col., top para). Colle teaches succinobucol as the monosuccinic acid ester of probucol having the same antioxidant and anti-inflammatory properties of probucol, but without the associated cardiovascular adverse effects (p. 126, left col., 2nd 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 incorporated succinobucol as a pharmacologically active compound into the composition of Kimura, in view of the teachings of Colle. As discussed previously, Kimura teaches compositions comprising an active agent such as probucol; and absorbefacient such as deoxycholic acid and a cyclodextrin. Although succinobucol is not mentioned within Kimura, Colle teaches succinobucol as the monosuccinic acid ester derivative of probucol, and that succinobucol possesses the same antioxidant and anti-inflammatory properties of probucol without the associated cardiovascular adverse effects. As such, one of ordinary skill in the art would have found it prima facie obvious to have incorporated succinobucol as a pharmacologically active agent into the composition of Kimura, given that it has medicinal properties without the cardiovascular side effects associated with probucol, and have had a reasonable expectation of success.
Claim Objections
Claims 76, 78, and 80 are objected to 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.
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.
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
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