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 Applicant’s Remarks and Amendments filed on 03/09/2026 is acknowledged. Claims 1-31 are pending.
Claim 14 is canceled.
Claims 1, 2, 11, 13, 15-20, 22, 29 and 31 are amended.
Claim 32 is new.
Claims 1-13 and 15-32 are pending in this application.
Claim Rejections - 35 USC § 112
The rejection of claims 2, 11 and 31 under 35 U.S.C. 112(b) as previously set forth in the Office Action of December 8, 2025 is hereby WITHDRAWN.
Applicant have amended claims 2, 11 and 31 to recite FK506 (tacrolimus) to designate the intended chemical compound in the claims, which resolves the FK506 abbreviation indefinite issue. No further response to the § 112(b) arguments is required.
Response to Arguments
Applicant's Reply, filed March 9, 2026, argues that the prior art of record fails to disclose or suggest (1) the sequential two-extruder arrangement recited in independent claims 1 and 22, and (2) a polymer surface treated with polyethylene glycol as recited in independent claim 29. Applicant's arguments have been fully considered. However, the rejections are maintained and reformulated with additional prior art as set forth below.
Regarding Claims 1 and 22 — Two-Extruder Limitation:
Applicant argues that Davis (WO 2020/150226 A1) fails to describe combining a polymer and neuro-regenerative or immunosuppressive agent within a first extruder to form a combination, and then inputting that combination into a second extruder for melting and film formation. Applicant correctly notes that Davis paragraph [0033] merely mentions melt extrusion as an alternative to solvent casting in a general manner, without disclosing the specific two-extruder sequential process now claimed.
The Examiner acknowledges that Davis, Goonoo, and Yang, as relied upon in the previous Office Action, do not individually or in combination explicitly teach the sequential two-extruder arrangement of claim 1 as amended. Accordingly, the prior § 103 rejection is not maintained in its original form. However, as detailed below, the newly introduced reference of Breitenbach provides the missing teaching of the two-extruder sequential process, and the rejection is now properly established over the combination of Davis, Goonoo, Yang, and Breitenbach.
Regarding Claim 29 — PEG Surface Treatment:
Applicant argues that Yang teaches polyethylene glycol (PEG) as a film component or matrix excipient, but does not teach a polymer that is surface treated with PEG as required by claim 29. The Examiner agrees that Yang does not specifically teach PEG surface treatment of a biodegradable polymer prior to extrusion. Accordingly, the § 103 rejection of claim 29 is not maintained based solely on Yang for this limitation. As set forth below, the newly cited reference of Gref provides the teaching of PEG surface treatment of biodegradable polyester polymers to improve biocompatibility and implant performance, and the rejection of claim 29 is now properly established.
New Rejections Necessitated by Amendments
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.
Claims 1-13 and 15-32 are rejected under 35 U.S.C. 103 as being unpatentable over (WO 2020/150226 A1) hereinafter the reference is referred as Davis in view of
Polydioxanone-based bio-materials for tissue engineering and drug/gene
delivery applications (hereinafter the reference is referred as Goonoo); Yang (US 11,207,805 B2); Melt extrusion: from process to drug delivery technology (hereinafter the reference is referred as Breitenbach) and further in view of Biodegradable Long-Circulating Polymeric Nanospheres (hereinafter the reference is referred as Gref).
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).
Regarding claim 1, Davis teaches a method in a preferred embodiment, the one or more neuro-regenerative drugs to be incorporated into the polymer film, and the polymer utilized to form the film, each have a hydrophobicity/lipophilicity that makes the drug(s) readily soluble in the polymer, and the one or more drugs are dissolved in a suitable organic solvent that is then added to a polymer solution prior to curing. The polymer solution containing the dissolved drug(s) may then be solvent cast into a desired film thickness. Other polymer manufacturing methods, such as melt extrusion and/or other methods known in the art, may be utilized to form the films. Curing may be carried out under vacuum and/or using other suitable curing procedures, and following curing, the films may be cut to desired sizes if not already cast to size. The films may therefore be sized to fit any size nerve or gap according to particular application needs (¶ 0033). Furthermore, Davis discloses other incorporation procedures known in the art may additionally or alternatively be utilized to incorporate the one or more drugs into the polymer. For example, at any suitable step during manufacture of the film, the one or more drugs may be contacted with the polymer by mixing, spraying, immersion, etcetera. In some embodiments, the drug(s) may be included in a monomer blend prior to and/or during polymerization of the monomers in order to incorporate the drug(s) into the resulting polymer (¶ 0034). Therefore, as noted above, the limitation of a method in preparing an implantable biomaterial film comprising a combination of a polymer, a neuro-regenerative agent or an immunosuppressive agent 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 is taught and polymer manufacturing methods, from example, hot melt extrusion and/or other methods are known in the art, may be utilized to form the films (¶ 0033, lines 6-7).
Regarding claim 2, Davis teaches FK506 and rapamycin (¶ 0019).
Regarding claim 3, Davis teaches the polymer solution containing the dissolved drug(s) may then be solvent cast into a desired film thickness (¶ 0033), for example, a film thickness suitable for a nerve wrap application may be within a range of about 100 μm to about 600 μm, or about 150 μm to about 500 μm, or about 200 μm to about 400 μm (¶ 0025), and wherein the polymer film has a thickness within a range of about 100 μm to about 600 μm, or about 150 μm to about 500 μm, or about 200 μm to about 400 μm (claim 10). The claimed range of about 10 µm to about 200 µm overlaps with and is encompassed by the broader thickness ranges taught in the art. It would have been obvious to optimize thickness within this range based on the specific application.
Regarding claim 4, Davis teaches the medical polymer film comprises surface micropattern, wherein the ridges have a width of about 1 μm to about 20 μm, or about 3 μm to about 10 μm, and wherein the grooves have a width of about 1 μm to about 20 μm, or about 3 μm to about 10 μm (claims 13-15). Davis teaches that the film may be sized to fit any size nerve or gap (¶ 0033).
Regarding claim 5, Davis teaches medical materials that effectively combine localized drug delivery with the functionality of an implantable medical film (¶ 0013, lines 1-2).
Regarding claim 6, Davis teaches 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), the one or more drugs may be loaded such that when film is wrapped/rolled configuration, a concentration gradient exists between proximal end and distal end of the wrap (¶ 0027). Moreover, Davis discloses where a nerve wrap is used to bridge a nerve gap, axons will need to extend and bridge the gap. The use of surface micropatterns can promote neural cell orientation and guide growth of the cells along the ridges/grooves (¶ 0029). Moreover, Davis discloses, medical film embodiments described herein are particularly beneficial in nerve wrap applications for treating nerve injuries. Nerve wraps may be utilized, for example, in treating transected nerves (gap injuries), crushed nerves, and/or chronic nerve injuries, and some embodiments, such as in treating a gap injury, a nerve wrap may be utilized in conjunction with a direct suture repair (i.e., direct end to end repair) procedure. For example, a nerve may be repaired using epineural sutures followed by wrapping with a nerve wrap (¶ 0040).
Regarding claim 7, Davis teaches multi-layer (¶ 0005 and ¶ 0027) and wherein the polymer film includes an outer layer and an inner layer, the one or more drugs being incorporated into the inner layer, and the outer layer being configured to limit passage of the one or more drugs such that delivery of the one or more drugs is uni-directional (claim 16).
Regarding claims 8-9, Davis teaches method of use are particularly beneficial in nerve wrap applications for treating nerve injuries, and nerve wraps may be utilized, for example, in treating transected nerves (gap injuries), crushed nerves, and/or chronic nerve injuries. In some embodiments, such as in treating a gap injury, a nerve wrap may be utilized in conjunction with a direct suture repair (i.e., direct end to end repair) procedure. For example, a nerve may be repaired using epineural sutures followed by wrapping with a nerve wrap (¶ 0040). Furthermore, Davis discloses the nerve wraps described herein may also be utilized in conjunction with an autograft or allograft. For example, an autograft or allograft may be used to bridge a gap in a nerve, and a nerve wrap may be positioned around the autograft or allograft (and preferably also extended over the injured nerve ends). Where a nerve allograft is utilized, an immunosuppressant drug such as FK506 beneficially inhibits an immune response and thus reduces immune cell infiltration as compared to when the wrap omits the drug (¶ 0041), and medical films described herein may also be utilized in other applications where tissue compartmentalization and/or extended drug-release are called for. For example, a medical film as described herein may be utilized following abdominopelvic surgery to act as an anti-adherence barrier and prevent the formation of intra-abdominal adhesions. In another example, a medical film as described herein may be utilized to prevent organ and/or tissue rejection following allotransplantation. For example, the medical film may be positioned around the transplanted organ and/or tissue for extended local delivery of one or more drugs such as immunosuppressant FK506 (¶ 0042). Therefore, it would have been obvious for a person skilled in the art to experiment and use the implantable biomaterial film and attached to an outer and/or inner layer of the implant in order to achieve its beneficial effects thereof.
Regarding claims 10, synthetic material, Davis teaches the polymer film includes a copolymer of lactide and caprolactone (abstract), and 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 (¶ 0014). Therefore, the limitation of a synthetic material in addition to the film is taught.
Regarding claim 11, Davis teaches the one or more drugs may be loaded to a concentration (w/v) of about 0.001 % to about 1%, or about 0.01% to about 0.1%, including about 0.05%. The concentration of the one or more drugs may depend on the type(s) of drugs utilized. For example, the foregoing concentration ranges may be suitable when FK506 is utilized. However, other drugs described herein may be included at higher concentrations, such as about 2% to about 50%, or more preferably about 4% to about 30%, or about 6% to about 20%, or about 8% to about 15%. When
the one or more drugs are incorporated into the polymer at concentrations within the foregoing ranges, the resulting film is able to provide effective neuro-regenerative capabilities (¶ 0035). The claimed range of about 1% to about 20% FK506 by weight overlaps with Davis's disclosed ranges, rendering this limitation obvious.
Regarding claims 12-13, Davis teaches incorporation of a neuro-regenerative drug into a polymer film and when the one or more drugs are incorporated into the polymer at concentrations within the foregoing ranges, the resulting film is able to provide effective neuro-regenerative capabilities (¶ 0033), and the neuro-regenerative
drug includes the macrolactam immunosuppressant FK506 (abstract), and FK506 is an FDA approved immunosuppressant drug used to prevent allograft organ rejection. FK506 is an appealing drug candidate for use in nerve regeneration applications
because it has been shown to improve functional outcomes in vivo after peripheral nerve injury via its neurotrophic effects and through reduction of scar formation (¶ 0017).
Regarding claim 21, Davis teaches cutting the film into sheets of desired size (¶ 0033).
Regarding claim 31, Davis teaches cooling and collecting the film (¶ 0033) with FK506 (tacrolimus) as the neuro-regenerative or immunosuppressive agent (abstract, ¶ 0017).
Davis fails to specifically teach polydioxanone.
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).
Regarding claim 4, Goonoo teaches PDX films having widths suitable for biomedical applications. Therefore, Davis’s teachings above that the film may be sized to fit any size nerve or gap in view of Goonoo, optimization of film width within the recited range of about 6.4 mm to about 100 mm would have been obvious.
Regarding claims 23-25 and 28, Goonoo teaches polydioxanone blends of PDX with natural and synthetic polymers have been electrospun or processed by other techniques for applications such as vascular tissue engineering (¶ 3.4). Moreover, Goonoo discloses electrospun biodegradable scaffolds such as poly(lactic acid)
(PLA), poly(glycolic acid) (PGA), poly(caprolactone) (PCL), in addition to natural polymers such as collagen and elastin have been extensively investigated for vascular tissue engineering (¶ 3.4.1), and copolymerization of monomers or blending of polymers allows adjustment of biological, chemical and mechanical properties for tissue engineering applications, and the electrospun diblock PCL-b-PDX nanofibrous scaffold with average fiber diameter of 3 µm was fabricated by prior art (¶ 3.5.3). In another example, poly(x-pentadecalactone-co-dioxanone) [poly(PDL-co-DX)] copolymers, gave tissue responses comparable to PDX in in vivo experiments using mice model (page 382, right column, last ¶), and in a further example, drug-eluting nanofibrous mats using a variety of polymers including PDX have been investigated for several applications ranging from cancer therapy to wound dressings. The anti-microbial effects of vancomycin (VANC) and rifampicin-loaded (RIF) electrospun PDX fibers and the VANC and RIF were loaded in the electrospun fibers in varying wt% by solution electrospinning The effect of drug-loaded fibers on the inhibition of biofilm growth containing
osteomyelitis (OM)-associated pathogens was investigated, and concluded that the 10% VANC + RIF-loaded PDX fibrous mat was the best combination to control bacterial growth (page 388, right column, last ¶). Moreover, Goonoo teaches polydioxanone as the polymer (claim 23), PDX copolymers with poly(trimethylene carbonate), poly(glycolide), poly(d,l-lactide), poly(l-lactide), and poly(caprolactone) (claims 24-25, 28), random copolymers at 40-90% PDS (claim 26), and block copolymers at 45-85% PDS (claim 27). Therefore, these paragraphs suggests the known combination of PDX and copolymerization with other polymers are widely known in state of the art, and thus the limitations are taught.
Regarding claims 26-27, Goonoo teaches random P(DX-co-MeDX) copolymers (page 381, left column, 2nd ¶ first line) and examples of the amount of copolymer with the polydioxanone are 50:50 PDX/elastin (page 378, left column, ¶ 3), 50:50 PDX/silk (page 378, left column, ¶ 5).
Regarding claim 30, Goonoo teaches Triclosan was successfully loaded into PDX fibers by molecular diffusion with a swelling solvent and loading by means of a coating based on polycaprolactone or polycaprolactone/magnesium stearate mixtures (page 388, right column 1st ¶). Therefore, the limitation wherein the polymer contains a basic salt is taught.
Goonoo fails to specifically teach the technique of hot melt extrusion fabrication method for an implantable biomaterial film.
Yang teaches methods of preparation directed to film products comprising polymer component, which includes polyethylene oxide optionally blended with hydrophilic cellulosic polymers, and the films also contains a pharmaceutical active agents (abstract). Moreover, Yang teaches processes for preparing implantable biomaterial films using hot melt extrusion and casting processes, including the use of a film take-off unit comprising a pair of nip rollers to control film thickness and uniformity (column 3, lines 13-22; column 5-6, lines 25-52; column 11, lines 16-19; column 15, lines 34-52; column 27, lines 36-41). Yang teaches operating the take-off unit at a speed approximately 2 to 5 times faster than the extrusion speed to control film thickness, cooling with liquid coolant, collecting the film, and cutting into sheets (column 2, lines 34-35; column 27, lines 38-41). Yang discloses nip roller gaps of 10 to 60 microns and film speeds of 0.3 to 6.1 meters per minute.
Regarding claim 15, Yang teaches a film take-off unit comprising nip rollers used to compress or stretch the film to control thickness (column 5-6, lines 25-52). Yang is relied upon for the take-off unit only, with Breitenbach supplying the two-extruder process from claim 1. It would have been obvious to incorporate the film take-off unit of Yang into the combined Davis/Goonoo/Breitenbach manufacturing process to achieve controlled film thickness.
Regarding claim 16, Yang teaches operating the film take-off unit at a constant speed to produce a film of approximately constant thickness (column 3, lines 13-22).
Regarding claim 17, Yang teaches operating the take-off unit at a speed approximately 2 to 5 times faster than the extrusion rate (column 5-6).
Regarding claim 18, Yang teaches film speeds immediately downstream of the roller from 0.3 to 6.1 meters per minute (column 11, lines 16-19).
Regarding claim 19, Yang teaches collecting the film with the take-off unit (column 2, lines 34-35).
Regarding claim 20, Yang teaches cooling the roller with liquid coolant (column 27, lines 38-41).
Breitenbach teaches the well-established pharmaceutical manufacturing process of tandem hot melt extrusion, wherein a first extruder (twin-screw) is used to combine and compound a drug and polymer under high-intensity mixing conditions, and the resulting combined material is then input into a second extruder (single-screw) which serves as the melting, pumping, and shaping device for forming the final film or rod product (pages 107-117). Breitenbach explicitly discloses a setup of a twin-screw extruder for high-intensity mixing mated to a single-screw extruder as a heat exchanger and pumping device. Breitenbach teaches this tandem process as a known, well-characterized method for producing pharmaceutical drug-polymer films and implantable devices.
Regarding claim 32, as noted above, Breitenbach explicitly teaches that in a tandem extrusion system, the first extruder (twin-screw compounder) and the second extruder (single-screw shaping device) are different, physically separate extruders performing distinct unit operations.
Claim 29 is rejected under 35 U.S.C. § 103 as being unpatentable over Davis (WO 2020/150226 A1) in view of Goonoo, further in view of Breitenbach, and further in view of Gref (Biodegradable Long-Circulating Polymeric Nanospheres).
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.
Regarding claim 29, It would have been prima facie obvious to a person of ordinary skill in the art to apply the PEG surface treatment of biodegradable polyesters taught by Gref to the polydioxanone polymer of Goonoo used in the Davis-type implantable biomaterial film. One would have been motivated to do so because: (1) Gref establishes that PEG surface treatment of biodegradable polyesters is a known technique for improving biocompatibility and reducing inflammatory response at implant sites, and the properties directly desirable for a nerve repair film as taught by Davis; (2) polydioxanone, as a structurally related aliphatic polyester, would have been recognized as amenable to the same PEG surface treatment technique disclosed by Gref; and (3) a person of ordinary skill in the art would have had a reasonable expectation of success in applying the well-known PEG surface treatment methodology to PDX-based implantable films to achieve improved biocompatibility, with results predictable from Gref's teachings. The combination yields nothing more than expected results from the application of a known technique (PEG surface treatment of biodegradable polyesters) to a known material (PDX-based nerve wrap film). See KSR, 550 U.S. at 417.
Regarding claim 1, It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the drug-loaded implantable biomaterial film of Davis with the polydioxanone polymer of Goonoo and the tandem two-extruder manufacturing process of Breitenbach. One would have been motivated to do so because: (1) the combined teachings of Davis and Goonoo establish that FK506/tacrolimus-loaded biodegradable polyester films, including PDS-based films, are known and desirable for implantable nerve repair applications; (2) Breitenbach establishes that the tandem two-extruder process (first extruder for drug-polymer combination, second extruder for melt-shaping into a film) is the conventional, well-characterized manufacturing methodology for precisely this type of pharmaceutical drug-polymer film preparation; and (3) a person of ordinary skill in the art would have recognized that using the known tandem extrusion process of Breitenbach to manufacture the drug-loaded PDX-based film of Davis/Goonoo would yield predictable results, namely a homogeneously compounded drug-polymer film with controlled thickness and drug distribution suitable for nerve wrap applications. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007); MPEP § 2144.06(I).
Regarding claim 22, the claim recites a method of preparing an implantable biomaterial film comprising combining a polymer and a neuro-regenerative or immunosuppressive agent to form a combination in the form of particles, wherein the polymer is a homopolymer, copolymer, or polymeric blend including the recited monomers, the combination including particles containing the polymer and agent; inputting the combination into an extruder; melting the polymer within the extruder; and extruding to form the film. Davis, Goonoo, and Breitenbach collectively teach these limitations as set forth above with respect to claim 1. Breitenbach specifically teaches that the combined drug-polymer material exiting the first (twin-screw compounding) extruder is commonly produced as pellets or particles, which are then input into the second extruder — directly corresponding to the claimed combination in the form of particles being input into the extruder.
One of ordinary skill in the art would have found it obvious to combine prior art elements according to the known methods to yield predictable results.
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.
/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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