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 .
Summary
Receipt of Applicants’ Arguments, Remarks and amended claims filed on 08/05/2026 is acknowledged.
Claims 28-33 and 35-52 are pending.
Claims 1-27 and 34 are cancelled.
Claims 46-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 28, 35, 39 and 41 are amended.
Claims 28-33 and 35-45 are pending and under examination in this application.
Election/Restrictions
The restriction requirement between Groups I, II, and III, made FINAL in the Office Action mailed 05/05/2026, is maintained for the reasons of record. No new traversal has been presented.
Election of Species
Applicant's prior election, without traverse, of (a) tin as the metal of claim 29; (b) corticosteroids as the active pharmaceutical ingredient of claim 30; and (c) dexamethasone as the active pharmaceutical ingredient of claim 31, remains in effect. The examination below addresses the elected species where applicable.
Priority
The current application filed on 08/21/2023 is a 371 of PCT/FI2022/050112 filed 02/21/2022, which in turn claims priority to patent application FI20215186 filed on 02/19/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/14/2023 are in compliance with the provisions of 37 CFR 1.98. Accordingly, the information disclosure statements has been considered by the examiner. Signed copies have been attached to this office action.
Claim Rejections - 35 USC § 112 - Withdrawn
The rejection of claim 28 under 35 U.S.C. 112(b) as indefinite for the duplicate designation of subclause “iv)” is WITHDRAWN in view of applicant's amendment correcting the claim to recite subclauses (i) through (vii) without duplication.
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) 28-33 and 35-45 are rejected under 35 U.S.C. 103 as being unpatentable over Bode (In-situ forming PLGA implants for intraocular dexamethasone delivery) in view of Glen (WO 2019/097262 A1), Melo (Critical analysis of techniques and materials used in devices, syringes, and needles used for intravitreal injections), Dunn (US 6461631 B1) and further in view of Dormer (WO 2017/189645 A1).
Overview of the Prior Art:
Bode discloses in-situ forming implant formulations based on poly(lactic-co-glycolic acid) (PLGA) — a bioresorbable polyester — and N-methyl-2-pyrrolidone (NMP) as biocompatible solvent, prepared and evaluated specifically for controlled intraocular delivery of dexamethasone, a corticosteroid. Bode’s PLGA/NMP/dexamethasone solutions are injectable liquid formulations that form an in-situ implant upon contact with aqueous vitreous humor by solvent exchange/phase inversion: NMP diffuses out of the injected liquid while water diffuses in, causing PLGA to precipitate and form a sustained-release solid depot (Abstract). The PLGA employed is a 50:50 poly(D,L-lactide-co-glycolide) with –COOH end groups (Resomer RG 502H and RG 504H; Evonik), synthesized using stannous octoate (Sn(Oct)₂) catalyst; NMP is the water-miscible biocompatible solvent; dexamethasone is the API (§ 2.1, Materials). PLGA concentration (≥30% w/w) and molecular weight are identified as decisive variables for phase inversion behavior and drug release (Abstract; § 3). The systems are designed for intravitreal delivery and are noted to be robust with respect to variations in vitreous humor volumes encountered in vivo (Abstract). Bode also notes that liquid in-situ forming PLGA/NMP formulations can be injected through substantially smaller needles than the 22G applicator required for Ozurdex, a preformed PLGA implant. (§ 1 Introduction). Bode additionally studies HPMC as an additive to the PLGA/NMP/dexamethasone formulation (§§ 2.2, 3.3). Section 3.4 and Fig. 6a further disclose formulations containing 45% Resomer RG 502H in NMP.
Glen discloses a bioresorbable polyester wherein the metal content of the polyester is >0 ppm and <40 ppm, and a controlled release pharmaceutical composition comprising at least one active pharmaceutical ingredient and at least one such polyester (Abstract; claims 1–6). Glen further discloses that the controlled release pharmaceutical composition is preferably an in-situ forming implant composition. Glen, p. 1 (“the present invention provides a method of forming a controlled release pharmaceutical composition, preferably an in-situ forming implant composition”). Glen teaches that the metal content limitation — arising from residual polymerization catalyst such as tin from Sn(Oct)₂ — is important for pharmaceutical acceptability and intraocular tolerability, and that this specification is achieved through purification of the bioresorbable polyester by a method comprising dissolving the polyester in a solvent and precipitating with a non-solvent. Glen, p. 2–3. Glen additionally discloses active pharmaceutical ingredients including dexamethasone and corticosteroids for use in its controlled release compositions for treatment of ophthalmic diseases. Glen, p. 4–5. Glen further discloses both linear and branched bioresorbable polyesters. Glen, claims; p. 3. The minimum injection volume disclosed in Glen is 0.25 mL (250 µL) — above the claimed 1–100 µL range.
Melo is a comprehensive pre-critical date review of intravitreal injection techniques, devices, syringes, and needles. Melo establishes 50 µL as the standard clinical intravitreal injection volume, with volumes of 10, 20, and 25 µL also clinically evaluated. Melo, §§ “Needles” and “Syringes.” Melo further documents that 27G–31G needles are the clinical standard for intravitreal injection.
Dunn discloses biodegradable, biocompatible, branched thermoplastic polyesters from lactide/glycolide monomers with multifunctional branching monomers for injectable in-situ forming drug delivery systems. Dunn, col. 1:20–40; col. 3:10–60; claims 1–5.
Dormer (WO 2017/189645 A1) published November 2, 2017, more than three years before the February 19, 2021 critical date of the instant application, and therefore qualifies as prior art under 35 U.S.C. § 102(a)(1). Dormer discloses biodegradable polymer microsphere compositions comprising PLA and PLGA for parenteral drug delivery, including intravitreal and subconjunctival administration (¶[0093]) and intraocular administration (¶[0100]). Dormer expressly teaches that lactide-containing biopolymers are preferably enriched in the L-enantiomer, with an L:D ratio of the two enantiomers ranging from 51:49 to 99.99:0.01 by weight, exemplified at 60:40, 75:25, 80:20, and 90:10 (¶[0053]). Dormer further confirms this L:D ratio teaching applies specifically to PLGA copolymers, stating that lactide within the copolymer is optically active and “any proportions of D and L isomers may be present in the copolymer... ranging from pure D-lactide to pure L-lactide” (¶[0057]). Dormer further teaches that the properties of polylactides — including degradation behavior — depend on molecular weight, degree of chirality, and degree of crystallinity (¶[0055]).
Claim by Claim rejections:
Claim 28 recites a controlled release pharmaceutical composition for eye injection comprising at least one active pharmaceutical ingredient (API), at least one biocompatible polymer, and at least one biocompatible solvent, wherein: (i) the composition is an injectable solution, suspension, emulsion, or dispersion; (ii) the composition is an in-situ forming implant composition; (iii) the biocompatible polymer is bioresorbable; (iv) the bioresorbable polymer comprises a polyester, wherein the polyester is a PLA or PLGA; (v) the composition volume is from 1 µL to 100 µL; (vi) the metal content of the polyester is >0 ppm and <40 ppm; and (vii) the PLA or PLGA comprises L-lactic acid and D-lactic acid units at an L:D molar ratio of 100:0 to 70:30.
Claim Limitation
Reference
Disclosure / Location
API; biocompatible polymer; biocompatible solvent
Bode
Abstract; § 2.1: dexamethasone (API); PLGA Resomer RG 502H/504H (bioresorbable polyester); NMP (biocompatible solvent)
(i) Injectable solution, suspension, emulsion, or dispersion
Bode
§§ 2.1–2.2: “liquid PLGA/dexamethasone/NMP formulations” administered via syringe; § 1: injectable liquid form explicitly described
(ii) In-situ forming implant composition
Bode
Abstract; § 1: phase inversion/solvent exchange mechanism upon contact with aqueous vitreous humor forms solid depot in situ
(iii) Bioresorbable biocompatible polymer
Bode
§ 2.1: PLGA — biodegradable/bioresorbable polyester by hydrolysis
(iv) Amended to Polyester is PLA or PLGA
Bode; Glen
Bode § 2.1: PLGA is a polyester of lactic acid and glycolic acid; Glen p. 2-3: discloses PLA and PLGA among bioresorbable polyesters
(second iv) Composition volume 1–100 µL
Melo + KSR
Epub April 18, 2020; §§ “Needles,” “Syringes”: 50 µL standard clinical IVT volume; 10, 20, 25 µL also clinically used. Optimization within this established range is routine under KSR, 550 U.S. at 421
(v) Metal content of polyester <40 ppm
Glen
Abstract; p. 1–3; claims 1–6: “a bioresorbable polyester wherein the metal content of the polyester is >0 ppm and <40 ppm”; in-situ forming ophthalmic composition; Sn(Oct)₂ residual catalyst controlled by purification
(vii) Amended to PLA or PLGA comprises L-lactic acid and D-lactic acid units at L:D molar ratio of 100:0 to 70:30
Dormer
[0053]: “L:D ratio of the two enantiomers ranging from 51:49 to 99.99:0.01 by weight, such as 60:40, 75:25, 80:20, or 90:10” — fully encompassing and exemplifying the claimed range
Bode discloses elements (i)–(iv): injectable PLGA/NMP/dexamethasone solutions — where PLGA is the bioresorbable polyester (corresponding to elements iii, iv), NMP is the biocompatible solvent, and dexamethasone is the API — that form in-situ implants upon intravitreal injection by phase inversion (corresponding elements i, ii) (abstract, pp. 337-338).
Regarding the volume limitation: Melo documents 50 µL as the clinical standard and smaller volumes (20–25 µL) as also used clinically. Adapting Bode’s formulation for intravitreal injection at a volume within this established clinical window is routine optimization of a known parameter, not invention. KSR, 550 U.S. at 421.
Regarding the metal content (<40 ppm): Glen expressly teaches that residual metal from bioresorbable polyester synthesis must be controlled below 40 ppm for acceptable intraocular tolerability, and that this is achievable through routine purification. Applying Glen’s specification to Bode’s PLGA — the same polymer class for the same intraocular application — is straightforward and carries a reasonable expectation of success.
Regarding limitation (vii): Dormer expressly teaches PLA/PLGA polymers enriched in the L-enantiomer at L:D ratios of 75:25, 80:20, and 90:10 — each falling squarely within the claimed 100:0 to 70:30 range — and identifies “degree of chirality” as a known variable governing polymer properties including crystallinity and degradation rate. Applying Dormer's L:D ratio teaching to Bode's PLGA is obvious: both references are directed to PLA/PLGA-based sustained-release parenteral drug delivery systems, and Dormer expressly contemplates intravitreal and intraocular administration — the same field as Bode's intraocular implant. A skilled artisan optimizing Bode's PLGA for a desired degradation/release profile would look to Dormer's L:D ratio teaching as a routine, result-effective variable. KSR, 550 U.S. at 421.
Claim 28 is prima facie obvious over Bode in view of Glen, Melo, Dunn, and Dormer.
Regarding claim 29, the claim recites metal selected from group including tin (elected species). Bode’s PLGA (Resomer RG 502H/504H; Evonik) is synthesized by ring-opening polymerization using Sn(Oct)₂ as catalyst (Bode, § 2.1). Glen expressly teaches controlling residual tin from Sn(Oct)₂-catalyzed PLGA to <40 ppm (Glen, Abstract; p. 2). Tin is the paradigmatic residual metal and the elected species. Obvious for reasons stated for claim 28.
Regarding claim 30, the claim recites API selected from group including corticosteroids (elected species). Bode uses dexamethasone — a corticosteroid — as the API throughout (Abstract; § 2.1). Glen also discloses corticosteroids as suitable APIs for controlled release ophthalmic compositions (p. 4–5). Obvious for reasons stated for claim 28.
Regarding claim 31, the claim recites API selected from group specifically including dexamethasone (elected species). Dexamethasone is the exact API of Bode’s disclosed in-situ forming intraocular formulation (Bode, Abstract; § 2.1). Glen also discloses dexamethasone by name (p. 4–5). Obvious for reasons stated for claim 28.
Regarding claim 32, the claim requires polyester purified by: (i) dissolving in an organic solvent comprising a heteroatom; (ii) precipitating with an alcohol non-solvent; (iii) separating precipitated polyester. Glen expressly teaches purifying the bioresorbable polyester by dissolving in a solvent and precipitating with a non-solvent to reduce metal content to <40 ppm (p. 2–3; claims 1-3). The organic solvents disclosed by Glen for polyester dissolution (e.g., dichloromethane, ethyl acetate, acetone) each comprise heteroatoms as required by element (i). The use of an alcohol as the precipitation non-solvent is expressly taught by Glen (p. 3). Obvious for reasons stated for claim 28.
Regarding claim 33, the claim recites total residual monomers <0.2 wt%. Glen’s purification process — dissolution/precipitation of the bioresorbable polyester — concurrently reduces residual lactide and glycolide monomers alongside catalyst metal content, as the same purification removes both. Controlling residual monomer content to meet pharmaceutical-grade standards is a routine quality parameter applied by the skilled artisan to PLGA for parenteral and ophthalmic use. Obvious for reasons stated for claim 28.
Regarding claim 35, the claim recites polyester is poly(lactide-co-glycolide). PLGA is the exact polymer employed throughout Bode (Abstract; § 2.1). Obvious for reasons stated for claim 28.
Regarding claim 36, the claim recites polyester is a purified polyester. Glen is specifically directed to purified bioresorbable polyesters with metal content <40 ppm for pharmaceutical use (Abstract; claims 1–6). Bode uses commercial pharmaceutical-grade (i.e., purified) PLGA (Resomer RG 502H/504H; Evonik) (Bode, § 2.1). Obvious for reasons stated for claims 28 and 32.
Regarding claim 37, the claim recites polyester is non-linear or branched. Glen discloses both linear and branched bioresorbable polyesters as suitable for its controlled release ophthalmic compositions (Glen, p. 5). Independently, Dunn expressly discloses biodegradable branched thermoplastic polyesters from lactide/glycolide monomers with multifunctional branching monomers for injectable in-situ forming drug delivery systems (Dunn, col. 1:20–40; col. 3:10–60; claims 1–5). Obvious for reasons stated for claim 28, further in view of Dunn. Applicant's showing of unexpected results is addressed in the Response to Arguments section below and does not overcome this rejection.
Regarding claim 38, the claim recites Biocompatible solvent: (a) dissolves ≥1 mg/mL polyester at 35–37 °C; (b) dissolves, disperses, or suspends the API. NMP dissolves PLGA at concentrations of ≥30% w/w (≥300 mg/mL) at physiological temperature, far exceeding the 1 mg/mL minimum, and dissolves or disperses dexamethasone (Bode, Abstract; §§ 2.1–2.2). Both functional requirements are met. Obvious for reasons stated for claim 28.
Regarding claim 39, the claim recites Biocompatible solvent selected from a Markush group including NMP, triacetin, DMSO, benzyl benzoate, benzyl alcohol, triethyl citrate, triethyl acetyl citrate, ethyl acetate, anisole, glycofurol, PEG, PPG, polycaprolactones, and combinations. Bode uses NMP explicitly (Bode, § 2.1). Glen discloses NMP and this same class of solvents for bioresorbable polyester-based ophthalmic compositions (Glen, p. 3–4). NMP is a named member of the Markush group. Obvious for reasons stated for claim 28.
Regarding claim 40, the claim recites composition further comprises a biocompatible excipient selected from a Markush group including vanillin, SAIB, polycaprolactonediol, HPMC, HP-β-CD, cyclodextrins, MCT, dextrans, sucrose, crown ethers, chitosan, mannitol, trehalose, and combinations. Bode explicitly evaluates HPMC (hydroxypropyl methylcellulose) as an additive in PLGA/NMP/dexamethasone in-situ forming intraocular formulations, studying its effect on implant formation, water uptake, and dexamethasone release (Bode, §§ 2.2 and 3.3). HPMC is a member of the Markush group of claim 40. Glen further discloses excipients including cyclodextrins for use in controlled release ophthalmic compositions (Glen, p. 4). Obvious for reasons stated for claim 28.
Regarding claim 41, the claim recites polymer:solvent weight ratio 40:60 to 60:40. Bode discloses a formulation containing 45% Resomer RG 502H in NMP (§ 3.4, Fig. 6a) — a 45:55 polymer:solvent ratio squarely within the claimed range. Obvious for reasons stated for claim 28.
Regarding claim 42, the claim recites composition volume 1–50 µL. Melo documents 50 µL as the standard clinical intravitreal injection volume, and confirms that 10, 20, and 25 µL volumes are also clinically used (Melo, §§ “Needles,” “Syringes”). The entire 1–50 µL sub-range falls within the established clinical standard. Obvious for reasons stated for claim 28.
Regarding claim 43, the claim recites API loading 0.1–90 wt% of total polymer+solvent weight. Bode studies initial dexamethasone loading as a variable affecting drug release kinetics, including a 7.5 wt% (of polymer) loading across multiple formulations (Bode, Abstract; § 3.2). Optimization of drug loading within a broad range is routine formulation design. Obvious for reasons stated for claim 28.
Regarding claim 44, the claim recites dynamic viscosity at 25 °C between 10 and 3,000 mPas. Bode characterizes PLGA/NMP solutions and identifies PLGA concentration and molecular weight as decisive variables for the physicochemical properties of the liquid formulation including rheological behavior (Bode, Abstract; § 3). Glen also addresses viscosity as a relevant property for injectable in-situ forming ophthalmic compositions. Glen, p. 3–4. Viscosity of PLGA/NMP solutions in the 10–3,000 mPas range is directly achievable by routine adjustment of PLGA concentration and MW, as exemplified in Bode. Melo confirms that formulation injectability through 27G–31G needles is a standard optimization parameter (Melo, § “Needles”). Obvious for reasons stated for claim 28.
Regarding claim 45, the claim recites formulated for delivery by injection needle G20–G31. Bode expressly states in the Introduction that a key advantage of liquid in-situ forming PLGA/NMP formulations over preformed implants is the ability to inject through smaller needles than the 22G applicator required for Ozurdex (Bode, § 1). Melo documents 27G, 30G, and 31G as the standard clinical intravitreal injection needle gauges (Melo, § “Needles”).The G20–G31 range encompasses the full spectrum of clinically relevant intravitreal gauges. Obvious for reasons stated for claim 28.
Motivation to Combine:
Bode and Glen: same field, directly complementary disclosures. Bode discloses the complete PLGA/NMP/dexamethasone in-situ forming intraocular implant formulation but does not address the metal content of the PLGA. Glen teaches that the metal content of the bioresorbable polyester in exactly this class of in-situ forming ophthalmic compositions must be controlled to <40 ppm for pharmaceutical acceptability and intraocular tolerability — a direct and specific motivation to apply Glen’s metal content specification to the PLGA component of Bode’s formulation. Both references are directed to bioresorbable polyester-based in-situ forming compositions for intraocular drug delivery. The combination requires no unpredictable modification and carries a strong reasonable expectation of success. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).
Volume optimization via Melo. Bode’s formulation is designed for intravitreal delivery. Melo establishes that 50 µL — and smaller volumes of 10–25 µL — are the standard clinical intravitreal injection volumes. Adapting Bode’s formulation for administration within this established clinical volume range is routine result-effective variable optimization requiring no inventive step. KSR, 550 U.S. at 421.
Branched polyester via Dunn. Dunn demonstrates that branched bioresorbable polyesters for injectable in-situ forming systems were well-established before the critical date. Substituting a branched PLGA variant to modulate release or mechanical properties is within routine formulation skill.
L:D ratio via Dormer. Bode discloses a complete PLGA/NMP/dexamethasone in-situ forming intraocular implant but does not specify the L:D lactide ratio of its PLGA. Dormer teaches that L-enantiomer-enriched PLA/PLGA (L:D ratios of 75:25, 80:20, 90:10) is preferred for controlling polymer properties in parenteral — including intravitreal and intraocular — drug delivery. Applying Dormer's L:D ratio teaching to Bode's PLGA is a routine formulation choice with a reasonable expectation of success, requiring no unpredictable modification.
Predictable results throughout. Every modification required to arrive at claims 28–45 from Bode involves applying: (1) Glen’s metal content specification to the PLGA component; (2) the standard intravitreal injection volume range established in Melo; and (3) known solvents, excipients, polymer types, and process parameters already disclosed in Bode and the art. None of these steps would have presented unpredictable results or required undue experimentation.
Response to Arguments
Applicant's arguments filed 08/05/2026 have been fully considered but are not persuasive for the reasons set forth below.
Applicant argues that none of the cited references teach or suggest newly added limitation (vii), the L:D molar ratio of 100:0 to 70:30. This argument is moot in view of the newly cited Dormer reference, applied above, which expressly teaches L:D ratios of 75:25, 80:20, and 90:10 for lactide-containing biopolymers used in parenteral, including intravitreal and intraocular, drug delivery. This rejection constitutes a new ground of rejection necessitated by applicant's amendment and is properly made FINAL under MPEP § 706.07(a).
With respect to claim 41, applicant argues that Bode “merely discloses 'appropriate amounts' of PLGA and dexamethasone were dissolved” (Bode, § 2.2, first sentence) and that none of the cited documents disclose a polymer:solvent weight ratio within the amended range of 40:60 to 60:40. This argument is not persuasive. While § 2.2 uses the general phrase “appropriate amounts” in describing the preparation procedure, Bode § 3.4 and Fig. 6a expressly disclose and characterize a formulation containing 45% Resomer RG 502H dissolved in NMP — a 45:55 polymer:solvent ratio falling squarely within the claimed 40:60 to 60:40 range. Applicant's argument addresses only the general procedural language of § 2.2 and does not address the specific quantitative disclosure of § 3.4/Fig. 6a, on which this rejection is based.
With respect to claim 37, applicant argues that Fig. 26 demonstrates unexpectedly good, more even release profile results for a branched polyester (PLGA5050 Branched) compared to a linear polyester (PLGA5050 Linear, RG502H). This argument is not persuasive for the following reasons.
First, applicant's showing is not commensurate in scope with the claims. Evidence of unexpected results must be reasonably commensurate in scope with the claimed invention. See MPEP § 716.02(d); In re Clemens, 622 F.2d 1029 (CCPA 1980). The formulation tested in Fig. 26 was injected at a volume of 0.25 mL (250 µL), as stated in the figure caption (“55% DMSO, 2.5 mg Exe, 0.25 ml Inj.”) — outside the 1-100 µL range required by claim 28, from which claim 37 depends. A showing limited to an embodiment falling entirely outside the scope of the claim cannot support the patentability of that claim. The burden is on applicant to establish that the showing is representative of the full scope of the claimed genus, including the claimed volume range, and applicant has not done so.
Second, the result is not unexpected in kind. An unexpected result must be a difference in kind, not merely in degree, from what the prior art would have predicted. See MPEP § 716.02(b); In re Huang, 100 F.3d 135 (Fed. Cir. 1996). Dunn already establishes that branched bioresorbable polyesters were known in the art specifically for their ability to modulate the properties of injectable in-situ forming drug delivery systems (Dunn, col. 1:20-40; col. 3:10-60). Bode's own data further confirm that changes in polymer chain architecture predictably alter release kinetics and water uptake behavior: compare Resomer RG 502H versus RG 504H, where differing chain length/molecular weight produced substantially different water/NMP content and release profiles (Bode, § 3.3, Fig. 5). A skilled artisan would therefore have expected that altering polymer architecture — linear versus branched — would likewise modulate release kinetics. A more even release profile falls within the expected range of outcomes from a known result-effective variable, not a difference in kind.
Third, applicant's showing carries insufficient evidentiary weight. Unlike Bode's release and characterization data, which are presented with triplicate measurements and standard deviations throughout (see, e.g., Bode §§ 2.4, 3.1-3.4, n=3 for all reported experiments), Fig. 26 presents a single, unreplicated comparison with no indication of statistical significance. A single data point, without replication or statistical analysis, is entitled to limited evidentiary weight. See MPEP § 716.02(b).
For at least these reasons, applicant's showing does not overcome the prima facie case of obviousness as to claim 37, and the rejection is maintained.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE MACH whose telephone number is (571)272-2755. The examiner can normally be reached 0800 - 1700 M-F.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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