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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 30-45 in the reply filed on May 31, 2026 is acknowledged.
Claims 46-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 31, 2026.
Specification
The disclosure is objected to because of the following informalities: “povidon” appearing throughout the specification is a typo for “povidone”.
Appropriate correction is required.
Claim Objections
Claim 30 is objected to because of the following informalities: in “instillation into the urinary bladder, or kidney for” the comma appears unnecessary and/or misplaced.
Claim 31 is objected to because of the following informalities: “comprising” is grammatically incorrect.
Claim 32 is objected to because of the following informalities: commas are missing in between some of the recited polymers; and “Poly…” need not be capitalized.
Claim 33 is objected to because of the following informalities: the “and” should be an “or” here.
Claim 34 is objected to because of the following informalities: a “thereof” should follow “combination”; “Witepsol®” is a registered therefore an ® is required; and “WitepsolTM” is followed by a space before the comma.
Claim 36 is objected to because of the following informalities: “comprising” should be “comprises”.
Claims 32 and 37 are objected to because of the following informalities: “PLGA” should be written out in the first instance (claim 32).
Claims 32 and 36-39 are objected to because of the following informalities: inconsistent forms of “copolymer(s)” and “co-polymer(s)”.
Claims 32 and 36-41 are objected to because of the following informalities: inconsistent forms of “PLGA” versus “PLGA co-polymers”.
Claims 40 and 41 are objected to because of the following informalities: “%w/w” needs a space after the percent sign.
Claim 42 is objected to because of the following informalities: “, ,”.
Claim 45 is objected to because of the following informalities: typo in “diisoprpanoamine”.
Appropriate corrections are required.
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.
Claims 30-45 are 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 30 recites “wherein a core is formed in situ in the urinary bladder or kidney upon instillation of phase B into phase A and wherein the formed core entraps and allows an extended release of the active agent”. It is unclear what is meant by the “core” here. The Specification does not define the term “core”. The ordinary and customary meaning of “core” is “a central and often foundational part usually distinct from the enveloping part by a difference in nature” or “the inmost or most intimate part” (“Core”, Merriam-Webster Dictionary, available at https://www.merriam-webster.com/dictionary/core accessed June 26, 2026). In other words “core” indicates something surrounding it. The specification does not discuss what might surround the core. The specification discloses that the core is a “solid or semi solid 3D” structure (para.0030), that it is “an amorphous spherical mass” (para.0064), and “has a diameter in the range of between 2 mm-15 cm, between 8 mm-8 cm or between 1-5 cm” (para.0102). Based on these disclosure it appears the “core” in the claim might simply be the solid or semi-solid that results when phase B is instilled into phase A, without anything surrounding it that makes it a “core” in the sense of the center of something. However such is not a customary meaning of “core”. Therefore the metes and bounds of what constitutes “core” cannot be ascertained. None of the dependent claims resolves this issue and therefore they are also rejected on this ground. For the purposes of examination now “core” is construed as a solid or semisolid mass.
Claim 31 recites “the group consisting of carbomer, …, gelatin, water, and optionally an alkali neutralizer”. Since the claim is reciting the group of gelling agents, the “optionally” is inapposite and raises confusion whether the intended meaning is that Phase A further comprises an alkali neutralizer. However it is unclear where the group ends since there is no “and” before the “water”, but the “and” does precede “optionally”.
Claim 34 contains the trademark/trade name Witepsol®. Claim 42 contains the trademark/trade name Epodyl®. 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 glycerol esters of vegetable saturated fatty acids (Witepsol®) and ethoglucid (Epodyl®) and, accordingly, the identification/description is indefinite.
Claim 37 recites “wherein the PLGA co-polymers have a monomer ratio compositions from 50:50 up to 85:15 poly(lactide-co-glycolide)”. Without an express indication the ratios could refer to either lactide:glycolide or glycolide:lactide and therefore the claim is ambiguous.
Claims 40 and 41 recite “comprising 0.1-45%w/w PLGA with inherent viscosity range from 0.15-0.25 dL/g, 0.1-35%w/w; and PLGA with …”. The phrase is incomprehensible. For the purposes of examination now this claim phrase is construed as “comprising either 0.1-45% w/w or 0.1-35% w/w of a PLGA with inherent viscosity ranging from 0.15-0.25 dL/g”.
Claim 44 recites “is released continuously for 1, 2, 3,… 30 or more days”. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 44 recites the broad recitation 1 day, and the claim also recites “30 or more days” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 31 and 45 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of hydrophilic gelling agent is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: specifically “water”, and “an alkali neutralizer” are not hydrophilic gelling agents such as the others recited. None of the dependent claims resolves this issue and therefore they are also rejected on this ground.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
Claim(s) 30-45 are rejected under 35 U.S.C. 103 as being unpatentable over Dor (US 2009/0074786) as evidenced by Lindquist (US 2009/0076595).
Dor teaches “liquid formulations which deliver a variety of therapeutic agents,…, to a subject for an extended period of time; …; non-dispersed mass-forming liquid formulations which form a gel or gel-like substance in an aqueous medium; liquid formulations, comprising a therapeutic agent and a plurality of polymers; …” (abstract; see entire document including the title; paras.0169, 0250, 0252, 0262, 0285 (all emphases within quotes in this Office action are added)). A gel or gel-like substance is semisolid.
Regarding Phase A, Dor teaches “the liquid formulations described herein may be administered with or further comprise a viscosity modifying agent” (para.0333) such as “cellulose gel” and others in claim 31, e.g., gelatin (paras.0335-36). Dor states, an “‘in situ gelling formulation’,… refers to a liquid formulation which forms a gel-like non-dispersed mass when the liquid formulation is placed in an aqueous medium, including but not limited to aqueous media that are water, the vitreous of a rabbit eye,…” (para.0281; see paras.0282-90). The “‘aqueous medium’ or ‘aqueous environment’ is one that contains at least about 50% water…[which] include but are not limited to gel structures” (para.0263). Dor teaches injection the solution into the area between the sclera and the conjunctiva, wherein the sclera comprises a “hydrogel structure” (paras.0262, 0346).
Regarding Phase B in claim 30, the in situ gelling formulation comprises, for example “(i) a solvent selected from the group consisting of N-methylpyrrolidone (NMP),…, and dimethyl sulfoxide (DMSO); (ii) poly(D,L-lactide-co-glycolide) (PLGA), or a solvent selected from the group consisting of propylene glycol (PG), polyethylene glycol 600 (PEG 600), polyethylene glycol 400 (PEG 400); and (iii) a therapeutic agent” (para.0081, Table 1 formulation 348; see, e.g., paras. 0185-86, 0203, 0284, 0289, 0578). Formulation 348 in Table 1 comprises PLGA 75/25 at 21.1% (Table 1 p.78). Lindquist is drawn to drug releasing medical devices and evidences that PLGA 75/25 with acid end groups has an inherent viscosity of 0.05-0.15 dL/g or 0.35-0.55 dL/g depending on the molecular weight (paras.0064-65).
The liquid formulations may further comprise a lipid such as those in claim 34 (para.0339).
Although mainly drawn to ocular administration, Dor teaches, “liquid formulations described herein, including but not limited to rapamycin-containing formulations …, may be used to treat, …transplanted organs or tissues including but not limited to …, kidney,…” (para.0138). Dor expressly teaches using its formulation to deliver an active agent into the kidney. Moreover suitable therapeutic agents include those in claims 42 and 43 (para.0113). Also regarding the claim phrase “for instillation into the urinary bladder [ ] or kidney", it is noted that the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. MPEP § 2111.02. Here Dor’s formulation is capable of forming a non-dispersing mass upon instillation into an aqueous medium, whether it is in the eye, or the bladder or the kidney.
Dor does not specifically teach an example precisely as recited in claim 30 wherein a “biphasic composition” of a hydrophilic hydrogel is combined with the liquid formulation comprising an organic solution, an active agent, and a hydrophobic polymer such as PLGA. However it would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to prepare such a composition because Dor teaches (i) “the liquid formulations” or Phase B “may be administered with or further comprise a viscosity modifying agent” (para.0333) such as “cellulose gel” (paras.0335-36), and (ii) the “‘in situ gelling formulation’,… forms a gel-like non-dispersed mass when the liquid formulation is placed in an aqueous medium,…” (para.0281; see paras.0282-90), wherein the “‘aqueous medium’ or ‘aqueous environment’ is one that contains at least about 50% water…[which] include but are not limited to gel structures” (para.0263).
Regarding claims 36 and 37, as noted above Dor teaches using PLGA (75/25) and “liquid formulations, comprising a therapeutic agent and a plurality of polymers” (abstract; para.0284; see paras.0081, 0578).
Regarding claim 44, the active agent is released over an extended period such as at least 30 days (para.0044).
Regarding claim 45 Dor teaches including pH stabilizers and buffers (parad.0341-42, 0344). Sodium hydroxide is a common alkalinizing agent.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614
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