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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/14/2026 has been entered.
Receipt of Applicant’s Remarks and Amendments filed on 07/14/2026 is acknowledged. Claims 1-13 and 15-32 are pending.
Claim 14 is canceled.
Claims 1, 7-10, 18, 22, and 29 are amended.
Claims 1-13 and 15-32 are pending in this application.
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.
Claims 1-13 and 15-32 are rejected under 35 U.S.C. 103 as being unpatentable over Pouletty et al. (WO 2019/020678 A1, hereinafter “Pouletty”) in view of Bersano (US 4,212,543) and Hall et al. (US 2011/0236666 A1, hereinafter “Hall”) and further in view of Davis (WO 2020/150226 A1), Goonoo et al. (“Polydioxanone-based bio-materials for tissue engineering and drug/gene delivery applications”, hereinafter “Goonoo”), Gref et al. (“Biodegradable Long-Circulating Polymeric Nanospheres”, hereinafter “Gref”), Ahlheim et al. (EP 2376070 B1, hereinafter “Ahlheim”), and Schwendeman et al. (US 6,743,446 B2, hereinafter “Schwendeman”).
Pouletty teaches process for preparing a drug delivery composition comprising the steps of a) preparing a masterbatch comprising a drug and a first polymer by (i) extruding the first polymer, wherein said first polymer has a melting temperature
below 140°C; and (ii) introducing the drug during extrusion of the first polymer, with a drug content between 0.1 % and 90%, based on the total weight of the masterbatch; and b) introducing the masterbatch in a polymer-based matrix during production of the drug delivery composition, wherein step a) is performed at a temperature at which the first polymer is in a partially or totally molten state, and step b) is performed at a temperature at which both the first polymer and at least a polymer of the polymer-based matrix are in a partially or totally molten state (abstract).
Bersano teaches in plastics material extruding installation, a number of layout arrangements of conventional twin-screw extruders with double-feed twin-screw extruders are provided in various combinations and in order to solve the
problems of a thorough degassing of the plastics material and of an intimate admixture of the several compounding ingredients or raw plastics materials so as to obtain a really homogeneous extrudate (abstract).
Hall teaches melt-extruded film is produced by a process which comprises
the steps of blending a) a water-soluble polymer, b) an active ingredient, and c) optional additives and subjecting the blend to melt-extrusion to produce an extruded melt and
drawing the extruded melt at a draw-down ratio of from 1. 5 to 20 to a film of a thickness of at least 0.04 mm (Abstract).
Davis teaches drug delivering nerve wrap comprising medical films that incorporates one or more neuro-regenerative drugs into a polymer film, wherein the polymer film includes a copolymer of lactide and caprolactone, and the neuro-regenerative drug includes the macrolactam immunosuppressant FK506 (abstract). Notably, Davis teaches medical materials that effectively combine localized drug delivery with the functionality of an implantable medical film. In particular, described herein are nerve wraps configured for localized delivery of one or more neuro-regenerative drugs to a nerve injury site. Embodiments described herein may be utilized to treat nerve injuries, and in particular peripheral nerve injuries, to improve functional nerve regeneration outcomes while limiting or avoiding harmful side-effects associated with systemic usage of neuro-regenerative drugs (¶ 0013). Notably, Davis discloses FK506 is embedded in a poly(lactide-co-caprolactone) polymer ("PLC") to create a drug-loaded film with mechanical properties that enable the film to be wrapped around nerves at a targeted nerve injury site. The film can effectively act as a barrier
to surrounding tissue while simultaneously providing extended, localized delivery of FK506, and such embodiments have shown ability to provide substantially linear, near zero-order drug release kinetics in a physiological environment for time periods of at least 30 days and likely substantially longer (e.g., potentially up to about 45 days or even up to about 60 days) (¶ 0014). Moreover, Davis discloses localized delivery of FK506 at the site of nerve repair, such as by using a medical film embodiment described herein, has the potential to improve outcomes without the harmful side-effects associated with systemic drug use (¶ 0017).
Goonoo teaches polydioxanone (PDX) as a biodegradable monofilament suture and reviews on the synthesis of PDX and its copolymers and provides for the first time an exhaustive account of its applications in the biomedical field with a focus on tissue engineering and drug/gene delivery (abstract). Moreover, Goonoo further discloses
biodegradable aliphatic polyesters such as poly(lactide) (PLA), poly(lactide-co-glycolide) (PLGA) and polycaprolactone (PCL) have attracted much interest for applications ranging from medical implants, bone fixation parts, scaffold fabrication, controlled drug
release devices to sustained release systems for pesticides and fertilizers and the major advantage with their use is that their degradation products can be removed by natural metabolic pathways. Generally, the copolymer PLGA is preferred compared to its constituent homopolymers for the fabrication of bone substitute constructs mainly because PLGA offers superior control of degradation properties by varying the ratio of LA and GA monomers. PLGA has a wide range of degradation rates, governed by
the composition of chains, both hydrophobic/hydrophilic balance and crystallinity and the possibility of controlling polymeric degradation rates allows matching with tissue regeneration rate for tissue engineering applications and control of drug release kinetics
for drug delivery (¶ 1. Introduction).
Gref teaches the surface treatment of biodegradable polyester polymers, specifically poly(lactic acid) (PLA) and related aliphatic polyesters structurally analogous to polydioxanone, with polyethylene glycol (PEG) to modify surface properties and improve biocompatibility of implantable polymer devices (pages 1600-1603). Gref discloses that PEG surface treatment of biodegradable polyesters reduces non-specific protein adsorption, increases hydrophilicity, reduces immunogenicity, and improves the in vivo performance of implanted biodegradable polymer materials. These properties are directly relevant to implantable biomaterial films intended for nerve repair applications as taught by Davis.
Ahlheim teaches pharmaceutical composition comprising one or more excipients to modulate active agent release behavior in an amount of 0.1% to 50% by weight. Specifically, disclosing inorganic basic salts such as zinc carbonate, magnesium hydroxide, or magnesium carbonate incorporated into polymer matrices (¶ 0020).
Schwendeman teaches basic salts such as magnesium hydroxide or magnesium carbonate incorporated into biodegradable polyesters (e.g., PLGA, PLA) to neutralize acidic degradation products, stabilize matrix pH, and control polymer degradation and drug release kinetics (Table 1; Examples 1-3).
Regarding claim 1, the claim recites a method of preparing an implantable biomaterial film comprising combining a polymer and a neuro-regenerative/immunosuppressive agent within a first extruder to form a combination having a first concentration of the agent; inputting the combination into a second extruder; melting the polymer with additional polymer within the second extruder; and extruding the combined polymer and agent via a die of the second extruder to form the film, the film having a second concentration of the agent that is less than the first concentration. Pouletty teaches:
Step a) / first extruder, first concentration: preparing a “masterbatch” by heating/extruding a first polymer while introducing a drug at a content of 0.1% to 90% by weight, “preferably by extrusion” (p. 3, ll. 21–30; p. 7, ll. 4–8; claim 1(a)).
- Step b) / second extruder, additional polymer, dilution: introducing the masterbatch into a “polymer-based matrix” (i.e., additional polymer) during production of the final composition, at a temperature at which both are molten, performed by extrusion or “cast film extrusion” (p. 19, ll. 12–19; claim 1(b)).
- Second concentration less than first — quantified: Example 1 (p. 22–23, Table 1) discloses a masterbatch of 50% naltrexone, subsequently diluted to a final drug delivery composition of 5% or 10% naltrexone — an explicit, worked reduction from a first (high) concentration to a second (lower) concentration.
- Film via a die: claim 17 lists “film” among the disclosed device forms; “cast film extrusion” is listed as a step (b) process performed in an extruder.
Pouletty does not expressly describe the two extruders as physically coupled, sequential apparatus stages (its examples run the masterbatch and dilution steps as separate operations, potentially in the same lab extruder). Bersano supplies this architecture: claim 1 discloses a first twin-screw extruder having two inlet openings and a discharge port, with screws feeding material to that port; and a second twin-screw extruder having an inlet port registering with the first barrel’s discharge port, whose screws “draw said materials received from the discharge port of said first barrel” and “feed said materials in one direction… through an extrusion head” (col. 2, ll. 25–30; col. 3, ll. 8–29, claim 1). The two stages run at independently variable screw speeds (col. 3, ll. 29–30, claim 1).
Motivation to combine (Pouletty + Bersano): A person of ordinary skill seeking to convert Pouletty’s batch-then-dilute masterbatch process into a continuous manufacturing operation would have looked to Bersano’s twin-screw, two-stage, double-feed extruder as a known apparatus expressly designed to combine and convey a pre-processed material from a first stage into a second stage for combination with additional material before final extrusion — the identical process sequence Pouletty teaches, implemented via known, conventional processing equipment. This is the use of a known technique (two-stage coupled extrusion) to improve a similar process (masterbatch dilution) in the same way, yielding predictable results. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
Regarding second concentration less than first — additional obviousness rationale: Even absent Pouletty’s explicit numeric example, diluting a fixed quantity of active agent by introducing additional polymer at the second extrusion stage necessarily and predictably lowers the agent’s concentration relative to the first-stage combination — no more than the predictable result of a known dilution technique.
Regarding claim 2 (FK506/rapamycin/nimodipine): Davis, as previously applied, discloses FK506 embedded in a polymer film (Final OA, p. 5 & 7). Davis teaches FK506 and rapamycin (¶ 0019).
Regarding claim 3 (thickness of about 10 µm to about 200 µm): Hall discloses a film thickness of at least 0.04 mm (40 µm), preferably 0.05 to 0.30 mm (50–300 µm) (¶ 0032), and Table 1 reports worked Examples 3 and 8 at a film thickness of 2 mil (0.05 mm = 50 µm) and Examples 1, 2, 5, 6, and 7 at 5 mil (0.13 mm = 130 µm) — each squarely within the claimed 10–200 µm range.
Regarding claim 4 (width of about 100 mm to about 6.4 mm): Hall’s Table 2 reports worked film widths of 82.5, 88.9, and 98.4 mm across Examples 1–6, and the Kollidon 90F/ibuprofen extrusion example reports a film width of 5.0 inches (127 mm) — each falling within, or immediately adjacent to, the claimed 6.4–100 mm width range.
Regarding claim 5 (implant): Goonoo discloses PDX-based biomaterials incorporated into numerous implant forms, including biodegradable monofilament sutures (Section 3.1), the Kalangos Biodegradable Ring for pediatric mitral and tricuspid heart valve repair (Section 3.2), PDS™ flexible plates, and electrospun/blended vascular grafts and conduits (Sections 3.3–3.4.1), any one of which satisfies incorporating the implantable biomaterial film "as part of an implant."
Regarding claim 6 (nerve connector/pre-rolled nerve wrap/sheet-like nerve wrap/nerve graft): Davis, as previously applied, discloses a drug-loaded medical film configured as a nerve wrap for localized delivery of a neuro-regenerative drug to a nerve injury site, wherein the film has mechanical properties enabling it to be wrapped around nerves at a targeted nerve injury site (¶ 0013–0014), satisfying the claimed nerve connector/wrap/graft limitation.
Regarding claims 7-10 (currently amended — film as part of a multi-layer implant; on inner surface; on outer surface; multi-layer implant with a synthetic-material layer): these amendments recast dependency from claim 5 to claim 1 and restate the “wherein” clauses as “further comprising” clauses without adding new substantive structure. Goonoo discloses a trilayered tubular conduit comprising three distinct layers — an elastin/gelatin (EG) layer, a PDX/elastin/gelatin (PEG) layer, and a PDX/gelatin (PG) layer — and expressly distinguishes the “outer layer” from the inner layers of the construct in describing the scaffold’s differential degradation behavior upon aging (Section 3.4.1; Fig. 3, caption). This multi-layer construction, with a PDX-containing (synthetic-material) layer positioned at both an inner and an outer position within the layered structure, continues to read on claims 7–10 for the same reasons set forth in the Final Office Action at pp. 16–18, now applied to amended claim 1’s base limitations via Pouletty/Bersano as set forth above.
Regarding claim 11 (FK506 1–20% by weight in the second-extruder combination): Pouletty discloses final drug-delivery-composition drug content ranging from 0.01% to 49% (p. 20, ll. 11–20), with the Example 1 worked embodiments at 5% and 10% — squarely within the claimed 1–20% range — combined with Davis’s teaching of FK506 as the agent (claim 2, above).
Regarding claim 12 (plurality of agents): Pouletty expressly contemplates “mixtures of at least two of these drugs” (p. 8, ll. 24–30).
Regarding claim 13 (agent both neuro-regenerative and immunosuppressive): Davis, as previously applied — FK506/tacrolimus is art-recognized as exhibiting both neurotrophic/neuro-regenerative and immunosuppressive activity.
Regarding claim 15 (film take-off unit, nip rollers, gap 10–60 µm): Hall discloses a film take-off unit comprising a Killion casting unit with “one set of nip-rolls” (Single Screw Extrusion example) used to draw and compress the extrudate to final film thickness, with worked film thicknesses as low as 0.05 mm (50 µm) achieved from a die lip gap of about 0.64–0.81 mm (25–32 mil) (Single Screw and Twin Screw Extrusion examples). Hall does not expressly quantify the nip-roll gap itself in microns as distinct from the die gap. However, the nip-roll gap in a take-off/casting unit is a result-effective variable directly controlling the final compressed thickness of the film exiting the rollers: because Hall already demonstrates that varying the draw-down ratio and roll parameters produces final film thicknesses spanning 50–250 µm from a single die-gap setting, a person of ordinary skill would have recognized the nip-roll gap as a parameter to be routinely optimized — including into the claimed 10–60 µm range — to achieve a desired final film thickness at the thinner end of Hall’s disclosed range, without unexpected results. In re Aller, 220 F.2d 454, 456 (CCPA 1955).
Regarding claim 16 (constant speed for constant thickness): Hall — “roll rotation speed is controlled to provide the desired film thickness and draw down rate from the extruded material” (p. 5, ¶ 0031– ¶ 0032).
Regarding claim 17 (take-off unit at 2–5× extrusion rate): Hall, Table 1 — reports draw-down ratios of 3.2, 6, 6.4, 15, and 16 across Examples 1–12, squarely encompassing and overlapping the claimed 2–5× range (Examples 1, 2, 4, 5, 6 fall at or near 3.2–6.4×).
Regarding claim 18 (currently amended — film speed immediately downstream of a roller of 0.3–6.1 m/min): Hall, Table 3 — reports casting roll speeds of 610–3048 mm/min (0.61–3.05 m/min), falling squarely within the claimed 0.3–6.1 m/min range.
Regarding claim 19 (collecting film with take-off unit): Hall — “Film was collected on a Killion film winder” (p. 6); “conveyed via the roll stack to a film winding station” (p. 6, Single Screw Extrusion section).
Regarding claim 20 (roller cooled with liquid coolant): Hall discloses casting/steel roll temperature controlled at 31°C in the twin- and single-screw examples, and at 14.5°C in the polyvinylpyrrolidone extrusion example, in each case using a “Mokon Compu-Mate 100 controller.” Mokon’s own product literature confirms that Compu-Mate-branded controllers are the control units for Mokon’s circulating water (and oil) temperature control systems — i.e., liquid-circulation heating/cooling units that regulate roll temperature by pumping a heat-transfer liquid through the roll — and that Mokon has manufactured such circulating-liquid temperature control systems since 1955. Given that a roll temperature of 14.5°C to 31°C is being actively maintained below typical melt-processing temperatures immediately after film formation, a person of ordinary skill would have understood the Mokon Compu-Mate controller in Hall’s examples to be operating in a cooling mode, circulating a liquid coolant through the casting roll to remove heat from the extrudate — consistent with the well-known function of Mokon circulating water/oil temperature control units in film-casting applications. This satisfies the claimed “liquid coolant.”
Regarding claim 21 (cutting film into a plurality of sheets): Hall, at (¶ 0034) — “The mono- or multilayered film can be cut into dosage forms according to a known manner.”
Regarding claim 22, the amended claim recites combining a polymer and agent to form a combination in the form of particles; inputting into an extruder; melting; extruding to form the film; and drawing the film with rollers such that a speed of translation is at least double a speed of the film immediately downstream of an opening through which the film is extruded. Pouletty teaches:
- Regarding Particles: shaping the masterbatch into a rod through a die, cooling, and chopping “in the form of granulates and/or pastilles of masterbatch” — i.e., particles (p. 15, ll. 12–17).
- Regarding inputting the combination into an extruder, melting the polymer within the extruder, and extruding the combined polymer and the neuro-regenerative agent or the immunosuppressive agent to form the implantable biomaterial film, the combination of Pouletty and Bersano discloses these limitations for the reasons set forth above in the rejection of claim 1.
- Regarding Draw ratio ≥2× via rollers, immediately downstream of the die opening: Hall defines “Melt Draw Elongation” = ((Vf − Vi)/Vi) × 100, where “Vi is the film velocity at the die and Vf is the film velocity at the take-up roll” (p. 5, para. [0031]) — the take-up roll being expressly “the first surface that the molten formulation contacts after leaving the die” (id.). Hall’s claims 1–2 independently claim a draw-down ratio of 1.5 to 20 (preferably 2.5 to 17), and Table 1 reports worked examples at ratios of 3.2–16 — all exceeding the claimed “at least double” (≥2) threshold.
- Regarding polymer identity (homopolymer, copolymer, or polymeric blend including one or more of glycolide, lactide, caprolactone, dioxanone, trimethylene carbonate, cellulose-derivative monomers, or other polyester-forming monomers): Goonoo, as previously applied to claims 23–28 — discloses polydioxanone (PDX) as a biodegradable poly(ester-ether) formed by ring-opening polymerization of the dioxanone (DX) monomer, together with copolymers and blends of PDX/DX with glycolide-, lactide-, and caprolactone-based polyesters and with cellulose derivatives such as cellulose diacetate (Sections 2, 3.5, 3.6.1.1.1, 3.6.1.2.1), satisfying the claimed polymer identity.
Motivation to combine: Controlling film draw-down ratio via take-up/nip rollers positioned immediately downstream of the die is a conventional, well-understood process parameter for controlling final film thickness and orientation in polymer film extrusion generally, and Hall specifically demonstrates its application in a drug-loaded melt-extruded film context analogous to the instant claims. A person of ordinary skill combining a polymer-and-agent masterbatch/dilution process (Pouletty) with a coupled two-stage extrusion apparatus (Bersano) would have looked to Hall’s established draw-down technique — itself applied to active-ingredient-loaded films — as a predictable means of achieving a desired final film thickness from the extrudate, representing no more than the combination of familiar elements according to known methods to yield predictable results.
Regarding claim 23, Goonoo teaches that polydioxanone (PDX) is synthesized by ring-opening polymerization (ROP) of DX (Section 2.1, p. 372).
Regarding claim 24, Goonoo discloses copolymers of DX with a second monomer, e.g., the random P(DX-co-MeDX) copolymer system prepared by non-sequential polymerization of DX with MeDX (Section 2.2, p. 373).
Regarding claim 25, Goonoo discloses that copolymers of PDX with PCL, PGA, PLA, and trimethylenecarbonate (TMC) “possessed new physico-chemical properties” (Section 3.6.1.2.2, p. 383), reading on PDS copolymerized with poly(caprolactone) (PCL), poly(glycolide) (PGA), poly(lactide) (PLA, encompassing the claimed d,l- and l-lactide forms), and poly(trimethylene carbonate) (TMC), respectively.
Regarding claim 26, the claim recites that the copolymer is a random copolymer comprising about 40% to about 90% polydioxanone (PDS) by weight. Goonoo, as previously applied to claims 23–25, discloses random copolymers of dioxanone (DX) with second monomers, such as methyl dioxanone (P(DX-co-MeDX)), lactide, glycolide, or caprolactone (Sections 2.2, 3.6.1.2.2). Goonoo further teaches that varying the monomer ratio within these aliphatic polyester copolymers directly governs the hydrophobic/hydrophilic balance, crystallinity, and polymeric degradation rates to control drug release kinetics (Section 1.0). Where the prior art teaches varying monomer ratios of a known copolymer system to control specific polymeric properties (degradation rate and release kinetics), establishing the specific claimed monomer percentage range of 40% to 90% PDS represents no more than routine optimization of a result-effective variable to achieve a desired degradation timeline, yielding no unexpected results. In re Aller, 220 F.2d 454, 456 (CCPA 1955); In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
Regarding claim 27, the claim recites that the copolymer comprises about 45% to about 85% PDS. As set forth above regarding claim 26, Goonoo teaches adjusting copolymer monomer compositions to tune degradation profiles. The claimed range of 45% to 85% PDS is fully encompassed within and narrower than the obvious 40% to 90% range of claim 26. Optimizing the PDS concentration within this narrower range to tune film degradation and drug release rate represents routine experimentation of a result-effective variable. In re Aller, 220 F.2d at 456.
Regarding claim 28, Goonoo, for the reasons set forth above regarding claim 25, teaches PDX copolymerized with PGA and PLA.
Regarding claim 29, the claim recites inputting a combination into an extruder; melting the polymer by raising the temperature of the combination to a range of about 150°C to about 250°C; extruding to form the film; drawing the film with rollers such that a speed of translation is at least double a speed… immediately downstream of an opening; wherein the polymer is surface treated with polyethylene glycol.
Regarding inputting into an extruder, melting the polymer, and extruding to form the film: Pouletty in view of Bersano teaches these limitations for the reasons set forth above in the rejection of claim 1.
Regarding Temperature 150–250°C — overlapping ranges: Pouletty discloses step (b) performed “at a temperature T between 50°C and 200°C, preferably between 60°C and 180°C, more preferably between 70°C and 160°C” (p. 18, ll. 15–17) — overlapping the claimed range at 150–200°C. Additionally/alternatively, Hall discloses “extrusion processing temperatures… from 50 to 210°C, preferably from 70 to 200°C, more preferably from 100 to 190°C” (p. 4, para. [0030]) — overlapping the claimed range at 150–190/200°C. Where the claimed range and the prior art range overlap, a prima facie case of obviousness exists. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003); In re Aller, 220 F.2d 454 (CCPA 1955).
Regarding Draw ratio ≥2×: as noted above, Hall teaches this limitation.
Regarding PEG surface treatment: Gref, as previously applied (Final OA, p. 5) — discloses PEG surface treatment of biodegradable polymeric particles/nanospheres to modify surface properties.
Motivation to combine (temperature overlap): Where Pouletty’s and Hall’s disclosed temperature ranges for extrusion/matrix-melting both independently overlap the claimed 150–250°C range, a person of ordinary skill would have recognized processing temperature as a routine result-effective variable — dependent on the specific polymer’s melting point and degradation threshold — that a PHOSITA would optimize through routine experimentation to achieve adequate polymer melt flow while preserving agent activity, without producing any unexpected result. In re Aller, 220 F.2d at 456.
Regarding claim 30, the claim recites that the polymer contains a basic salt, the basic salt being about 0.5% to about 10% of the polymer, by weight. Goonoo discloses that biodegradable aliphatic polyesters and poly(ester-ethers) such as PDS, PLA, and PLGA degrade via bulk hydrolysis into acidic degradation products (Section 1.0). Ahlheim discloses incorporating inorganic basic salts (such as magnesium hydroxide or magnesium carbonate) in an amount of 0.1% to 50% by weight into polymer formulations to modulate drug release behavior (¶ 0020), and Schwendeman demonstrates basic salts (e.g., magnesium hydroxide or magnesium carbonate) incorporated into biodegradable polyesters to neutralize acidic hydrolysis products and control polymer degradation kinetics (Table 1; Examples 1–3).
Motivation to combine: A person of ordinary skill in the art at the time of the invention would have been motivated to incorporate a basic salt as taught by Ahlheim and Schwendeman into the polymer matrix of Pouletty/Davis/Goonoo in an amount within the overlapping claimed range of 0.5% to 10% by weight in order to neutralize acidic hydrolysis products, prevent acid-catalyzed degradation of the active agent, and stabilize the matrix during hydrolytic degradation to achieve a predictable, steady drug release profile.
Regarding claim 31, Hall, as previously applied to claims 19 and 20 above, discloses collecting the film with a take-off unit (“Film was collected on a Killion film winder,” p. 6) and cooling a roller of the take-off unit with a liquid coolant via a Mokon Compu-Mate 100 controller regulating roll temperature through circulating heat-transfer liquid, combined with Davis’s teaching of FK506 as the neuroregenerative, immunosuppressive agent (Final OA, p. 5, as previously applied to claim 2 above).
Motivation to combine: Hall is already combined with Pouletty/Bersano for claims 3 and 15–21 to form and finish the film via a take-off unit. Extending that same apparatus to cool and collect the FK506-loaded film of claim 2 is the predictable application of a known film-forming/finishing technique to the base combination’s product, yielding no more than the expected result.
Regarding claim 32, Bersano, as previously applied to claim 1 above, discloses a first twin-screw extruder and a second twin-screw extruder as two distinct, physically separate barrels — the second barrel’s inlet port registering with the first barrel’s discharge port, each screw set running at independently variable speeds (col. 2, ll. 25–30; col. 3, ll. 8–30, claim 1). No further mapping is required beyond the claim 1 rejection set forth above.
Response to Arguments
Applicant’s arguments filed July 14, 2026, have been fully considered but are moot in view of the new grounds of rejection set forth above.
As discussed during the interview of June 18, 2026, and as reflected in Applicant’s remarks, the Office agrees that the previously cited combination of Davis, Goonoo, Yang, Breitenbach, and Gref did not disclose or suggest: (i) a combination having a first concentration of the neuro-regenerative agent or immunosuppressive agent associated with a first extruder, and the implantable biomaterial film having a second, lower concentration of that agent associated with a second extruder, as recited in claim 1; (ii) drawing the implantable biomaterial film with rollers such that a speed of translation of the film is at least double a speed of the film immediately downstream of an opening through which the film is extruded, as recited in independent claims 22 and 29; and (iii) melting the polymer by raising the temperature of the combination to a range of about 150°C to about 250°C, as recited in independent claim 29. Applicant’s arguments directed to these deficiencies — including the argument that columns 5–6 of Yang do not describe a take-off unit speed relative to the speed of film immediately downstream of an opening — are persuasive as applied to the previously cited combination, and that combination has accordingly been withdrawn in its entirety as to claims 1, 22, and 29 and all claims depending therefrom.
The rejections set forth above instead rely on a new combination of prior art — Pouletty, Bersano, and Hall — not previously of record, which remedies each of the identified deficiencies: Pouletty’s Example 1 (Table 1) discloses a masterbatch diluted from 50% naltrexone to a final composition of 5% or 10% naltrexone, disclosing the claimed first/second concentration limitation of claim 1; Hall’s Table 1 (draw-down ratios of 3.2–16, defined relative to the take-up roll immediately downstream of the die) discloses the “at least double” draw-ratio limitation of claims 22 and 29; and Pouletty (step (b) at 70–160°C) and Hall (extrusion processing at 100–190°C) each independently disclose temperature ranges overlapping the claimed 150–250°C range of claim 29. Because the rejections set forth above rely on this newly cited combination rather than the previously applied Davis/Goonoo/Yang/Breitenbach/Gref combination, Applicant’s arguments directed to the withdrawn combination — including those concerning Yang and Breitenbach — do not apply to, and are moot as to, the new grounds of rejection set forth above.
Conclusion
No claims are allowed.
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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