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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). A certified copy of Parent Application 10 2020 002 764.4, filed in Germany on 28 April 2020, has been received.
Claim Objections
In claim 28, the language “… [[characterized in that]] wherein circular expansions or reductions of the multilayer film material are …”
Claim 30 has been amended to read “The system according to claim wherein the entire intracorporeal portion and …” This claim should be amended to depend on claim 29.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-5, 7-22, 24, 25, 33, 37-40, 47 and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Nishtala; Vasu (US 20110282311 A1) in view of Usui; Shintaro et al. (US 20200109251 A1, published earlier as WO 2019004259 A1).
Regarding claim 1, Nishtala discloses a closed system for the delivery and/or discharge of odor-intensive substances to/from the body of a patient in the most odor-neutral manner possible (¶ [0005], [0062], FIG. 1A, a waste management system 10);
comprising a head unit (5) that is positionable in an interior space of the body of the patient (¶ [0062], FIG. 1A, a waste management system 10 includes a waste transport device, including a generally tubular body (e.g., catheter) 12; ¶ [0086] Another embodiment of a waste management system is illustrated in FIGS. 8A-8D. Waste management system 110);
includes a balloon-like element (3), and configured to retain and/or seal the system in the body of the patient (¶ [0062], a rectal section 18 … a retention cuff 24);
an extracorporeal container (11) including a film-based, bag-like compartment for receiving the substances to be delivered and/or discharged (¶ [0062], collection container 30; ¶ [0086], FIGS. 8A-8D … waste collection device 109); and
a tubular film-like structure (2) that connects the body interior space that is to be reached to the extracorporeal container (¶ [0062], extracorporeal section 22 … A body connector 26 is coupled to a proximal end of the extracorporeal section 22 and is configured for quick, secure coupling to a collection container connector 28 to place the body 12 in fluid communication with a collection container 30; ¶ [0085], FIG. 7D … Waste transport device 101 includes … an extracorporeal section 22).
Nishtala lacks a multilayer film material comprising a barrier layer made EVOH and/or PVDC and a carrier layer made of PUR, TPU, PVC, PA, TPE-A, or combinations thereof.
Usui discloses an ethylene-vinyl alcohol copolymer composition and a multilayer structure comprising a tubular film-like structure or a container (¶ [0002], [0041], [0084], [0086], [0096], [0099] Bags, cups, trays, tubes, bottles, and other containers, and caps produced from the film, the sheet or the stretched film formed in the aforementioned manner);
made of multilayer film material (¶ [0089], a multilayer structure);
comprising: at least one barrier layer (34), made of ethylene-vinyl alcohol copolymer (EVOH) and/or polyvinylidene chloride (PVDC), that acts as an odor barrier (¶ [0003] EVOH resin is excellent in transparency, gas barrier properties such as oxygen barrier property, aroma-retaining property, solvent resistance; ¶ [0012], an EVOH resin composition containing: (A) an EVOH resin; (B) an antioxidant; and (C) an iron compound; ¶ [0025] The EVOH resin (A) to be used in the present disclosure is a water-insoluble thermoplastic resin typically prepared by saponifying a copolymer of ethylene and a vinyl ester monomer, i.e., an ethylene-vinyl ester copolymer; ¶ [0027] The EVOH resin (A) thus prepared mainly contains an ethylene structural unit and a vinyl alcohol structural unit; ¶ [0031], an EVOH resin prepared by copolymerization with the hydroxyl-containing α-olefin is preferred); and
at least one carrier layer (35, 37, 39, 49) made of a robust, mechanically loadable material selected from the group comprising polyurethane (PUR), thermoplastic polyurethane (TPU), polyvinyl chloride (PVC), polyamide (PA), thermoplastic polyamide elastomer (TPE-A), or combinations thereof (¶ [0086] A multilayer structure … The layer formed from the EVOH resin composition of the present disclosure (hereinafter referred to simply as “EVOH resin composition layer”) may be laminated with some other base material (hereinafter referred to as “base resin”); ¶ [0087] Examples of the base resin include: (unmodified) polyolefin resins … polyamide resins (including polyamide copolymers), polyvinyl chlorides, polyvinylidene chlorides, acrylic resins, polystyrene resins, vinyl ester resins, polyester elastomers, polyurethane elastomers).
Usui provides a durable laminated film that can be formed into a film-based tube or container and which has high mechanical strength and an excellent gas barrier property (¶ [0086], Thus, the EVOH resin composition layer can be strengthened; ¶ [0097], The thickness of the multilayer structure … is typically 10 to 5,000 μm, preferably 30 to 3,000 μm; ¶ [0099] Bags, cups, trays, tubes, bottles, and other containers, and caps produced from the film; ¶ [0102] The multilayer pipe of the present disclosure is excellent in gas barrier property, because the EVOH resin composition contains the EVOH resin (A) as a major component; ¶ [0104], the multilayer pipe is excellent in barrier property, and is less susceptible to cracking due to the oxidative degradation).
One would be motivated to modify Nishtala with Usui’s multilayer film material since Nishtala calls for blocking odors and incorporates several references which describe anti-odor coatings (¶ [0091], In addition, the collection container 30 can include material in a wall thereof that absorbs/binds odor. Suitable examples … each of which is incorporated by reference in its entirety into this application). Therefore, it would have been obvious to modify Nishtala with Usui’s laminated film and EVOH or PVDC odor barrier layer in order to block odors and provide a durable film.
Regarding claims 2-5, 12, 16-17 and 19, Nishtala does not explicitly disclose a multilayer film comprising barrier and carrier layers. Usui discloses a system wherein the film-based tube components and/or balloon components of the head unit (5) are made of multilayer film material comprising: at least one barrier layer (34), made of ethylene-vinyl alcohol copolymer (EVOH) and/or polyvinylidene chloride (PVDC), that acts as an odor barrier (¶ [0003] EVOH resin is excellent in transparency, gas barrier properties such as oxygen barrier property, aroma-retaining property, solvent resistance; ¶ [0012], an EVOH resin composition containing: (A) an EVOH resin; ¶ [0025] The EVOH resin (A) to be used … i.e., an ethylene-vinyl ester copolymer; ¶ [0027] The EVOH resin (A) thus prepared mainly contains an ethylene structural unit and a vinyl alcohol structural unit; ¶ [0031], an EVOH resin prepared by copolymerization with the hydroxyl-containing α-olefin is preferred); and
at least one carrier layer (35, 37, 39, 49) made of a robust, mechanically loadable material (¶ [0086] A multilayer structure … some other base material (hereinafter referred to as “base resin”); ¶ [0087] Examples of the base resin include: (unmodified) polyolefin resins … polyamide resins (including polyamide copolymers), polyvinyl chlorides, polyvinylidene chlorides, acrylic resins, polystyrene resins, vinyl ester resins, polyester elastomers, polyurethane elastomers);
wherein the overall thickness dT of the carrier layer or of all carrier layers is greater than the overall thickness dB of the barrier layer or of all barrier layers: dT > dB; wherein the overall thickness dT of the carrier layer or of all carrier layers is greater than or equal to five times the overall thickness dB of the barrier layer or of all barrier layers: dT >= 5*d B (¶ [0098] The thickness ratio between the EVOH resin composition layer and the base resin layer of the multilayer structure (EVOH resin composition layer/base resin layer) … is typically 1/99 to 50/50, preferably 5/95 to 45/55, particularly preferably 10/90 to 40/60);
wherein the at least one carrier layer is made of a elastically deformable and elastically straightening carrier material (¶ [0086] A multilayer structure … some other base material (hereinafter referred to as “base resin”); ¶ [0087] Examples of the base resin include: (unmodified) polyolefin resins … polyamide resins (including polyamide copolymers), polyvinyl chlorides, polyvinylidene chlorides, acrylic resins, polystyrene resins, vinyl ester resins, polyester elastomers, polyurethane elastomers);
wherein the multilayer film material is made up of a sandwich-like combination, at least one central barrier layer being enclosed on both sides by at least one carrier layer each (¶ [0089], the layered configuration of the multilayer structure may be any combination of these layers, e.g., a/b, b/a/b, a/b/a, a1/a2/b, a/b1/b2, b2/b1/a/b1/b2, b2/b1/a/b1/a/b1/b2, or the like);
wherein the wall thickness of the multilayer film material is in a range of 10 μm to 5 mm (¶ [0097], The thickness of the multilayer structure (or the stretched multilayer structure) is typically 10 to 5,000 μm);
wherein the thickness of a barrier layer is in a range of 5 to 25 μm (¶ [0097], The thickness of the EVOH resin composition layer is typically 1 to 500 μm, preferably 3 to 300 μm, particularly preferably 5 to 200 μm);
wherein one or more layers of the multilayer film material are coextruded with one another (¶ [0093], a method in which a film or a sheet of the EVOH resin composition of the present disclosure is laminated with the base resin by melt extrusion … a method in which the EVOH resin composition and the base resin are coextruded … Of these methods, the coextrusion method is preferred);
Usui constructs a film that blocks odors and resists physical damage. Regarding the rationale and motivation to modify Nishtala with Usui’s various layers and materials, see the discussion of claim 1 above.
Regarding claims 24 and 25, Nishtala does not explicitly disclose that the balloon and the tubular film-like structure are made of the same multilayer film material, and/or the container and the tubular film-like structure are made of the same multilayer film material, and/or the balloon, the container, and the tubular film-like structure are made of the same multilayer film material, or that components that are made of the same multilayer film material are integrated with one another and/or manufactured as a unit. However, Nishtala calls for constructing two adjacent sections from the same material (¶ [0062], In another embodiment, each of the aforementioned components are made of a material (e.g., silicone) with the same durometer (e.g., about 50 Shore A); ¶ [0075], For example, in one embodiment, the material for the collection member 32 and sphincter section 20 are the same, but the thickness of the wall of the sphincter section 20 is less than the wall of the collection member 32). A skilled artisan would have been able to modify Nishtala’s system by constructing the various components from the same film material in order to simplify manufacturing or to minimize discontinuities in the system.
Regarding claim 33, Nishtala discloses a head unit that is insertable into an artificial or natural body opening (¶ [0062], Proximal of the rectal section is a sphincter section 20, particularly adapted for disposition in the anal region of a patient, and an extracorporeal section 22 generally positioned outside of the patient's body when the system is in use (although a portion thereof may be inside));
Nishtala does not explicitly disclose that the head unit may remain inserted in continuous placement for several days or weeks without causing trauma. However, Nishtala calls for a system that infuses medication which persists in the patient’s rectum (¶ [0064], Thus, the medication intended for the patient will remain for a longer period within the rectum). In another embodiment, Nishtala calls for a securement device that holds the tube (¶ [0110] FIG. 22 illustrates one embodiment of a securement device for a waste management system … Thus, the securement device described herein prevents the waste transport device from axial and rotational movement, leading to several benefits including, for example, longer indwell times, leak-minimization, proper seating of the waste transport device retention cuff, etc.). This suggests that Nishtala intends for the system and its tube to remain in place for an extended time.
Regarding claims 39, 40, 47 and 68, Nishtala discloses a degassing device having an outlet at which an internal overpressure within the system may be reduced by the release of gas, and having an adsorption and/or absorption and/or filter device that filters undesirable substances from the released gas (¶ [0086] Another embodiment … FIGS. 8A-8D … An odor control filter, made of a material such as carbon, may be embedded in the wall of the waste collection device 109 or may be a vent disposed therein);
wherein the degassing device is connected to a compartment of the container that receives the particular delivering and/or discharging substance (¶ [0086] Another embodiment … FIGS. 8A-8D … An odor control filter, made of a material such as carbon, may be embedded in the wall of the waste collection device 109 or may be a vent disposed therein);
wherein the longitudinal direction of the flow channel between the branch and the adsorption and/or absorption and/or filter device, with respect to the longitudinal direction of the conducting area between the branch and the drain connection, encloses an angle of 90° or less than 90° (¶ [0086] Another embodiment … FIGS. 8A-8D … An odor control filter, made of a material such as carbon, may be embedded in the wall of the waste collection device 109 or may be a vent disposed therein);
wherein the conducting area including a branch is integrated with or connectable to a catheter, which is anchorable in the patient via the balloon element (Fig. 8A, waste management system 110 includes waste transport device 111 and a waste collection device 109 which connect to retention cuff 24 and collection member 32).
Further regarding claim 47 and the longitudinal direction of the flow channel between a branch and the filter, Nishtala arranges a filter in a wall of the collection device 109 (¶ [0086]). This implies that the filter forms an approximately 90° angle relative to a flow direction through collection device 109.
Regarding claims 7-11, 13-15 and 18, Nishtala lacks a multilayer film material and its various layers. Usui discloses a film laminate wherein the at least one carrier layer is made of PUR having a Shore hardness of 80A to 95A or 55D to 65D, and/or of a thermoplastic PUR of a type having a water absorption according to DIN ISO 62 of 5% or less (¶ [0087] Examples of the base resin include … polyurethane elastomers);
wherein at least one carrier layer made of PVC is combined with at least one carrier layer made of PUR (¶ [0087] Examples of the base resin include … polyvinyl chlorides, polyvinylidene chlorides … polyurethane elastomers);
wherein at least one barrier layer of the two- or multilayer film material is joined to a carrier layer only at one side (¶ [0089] Where EVOH resin composition layers a (a1, a2, . . . ) … and base resin layers b (b1, b2, . . . ) are laminated together … the layered configuration of the multilayer structure may be any combination of these layers, e.g., a/b, b/a/b, a/b/a, a1/a2/b, a/b1/b2, b2/b1/a/b1/b2, b2/b1/a/b1/a/b1/b2, or the like);
wherein the barrier layer is made of PVDC (¶ [0029] The EVOH resin (A) … may further contain a structural unit derived from any of the following comonomers; ¶ [0030] The comonomers include: olefins such as propylene, 1-butene, and isobutene … halogenated vinyl compounds such as vinyl chloride, vinylidene chloride; ¶ [0063] The EVOH resin composition of the present disclosure may contain a thermoplastic resin other than the EVOH resin; ¶ [0064], Specific examples of the thermoplastic resin include polyolefin resins … polyvinylidene chlorides, vinyl ester resins);
wherein at least one carrier layer is made of PVC or PUR (¶ [[0087] Examples of the base resin include … polyvinyl chlorides, polyvinylidene chlorides, acrylic resins, polystyrene resins, vinyl ester resins, polyester elastomers, polyurethane elastomers, polystyrene elastomers);
wherein a carrier layer made of PVC is provided at one or both sides of the central barrier layer; wherein a carrier layer made of PUR is provided at one or both sides of the central barrier layer; wherein at least one carrier layer made of PVC is combined with at least one carrier layer made of PUR at each side of a central barrier layer (¶ [0089] Where EVOH resin composition layers a (a1, a2, . . . ) … and base resin layers b (b1, b2, . . . ) are laminated together … the layered configuration of the multilayer structure may be any combination of these layers, e.g., a/b, b/a/b, a/b/a, a1/a2/b, a/b1/b2, b2/b1/a/b1/b2, b2/b1/a/b1/a/b1/b2, or the like);
wherein the multilayer film material comprises: PVC, having a Shore hardness of 60A to 80A and a thickness of 140 to 280 μm at the inner side facing a central lumen, as an inner carrier layer, PUR, having a Shore hardness of 55D and a thickness of 50 to 100 μm, at the outer side facing away from the central lumen, as an outer carrier layer, and EVOH or PVDC having a thickness of 10 to 20 μm between the inner carrier layer and the outer carrier layer, as a central barrier layer (¶ [0029] The EVOH resin (A) … may further contain a structural unit; ¶ [0030] The comonomers include … halogenated vinyl compounds such as vinyl chloride, vinylidene chloride; ¶ [0063] The EVOH resin composition of the present disclosure may contain a thermoplastic resin other than the EVOH resin; ¶ [0064], Specific examples of the thermoplastic resin include polyolefin resins … polyvinylidene chlorides, vinyl ester resins; ¶ [0087] Examples of the base resin include … polyvinyl chlorides, polyvinylidene chlorides … polyurethane elastomers; ¶ [0097] The thickness of the EVOH resin composition layer is typically 1 to 500 μm … The thickness of the base resin layer is typically 5 to 3,000 μm).
Further regarding claim 18 and the combinations of materials, thickness ranges and laminating sequences, Usui describes all the claimed materials, thicknesses and sequences. A skilled artisan would have been able to experiment with Usui’s materials and dimensions by selecting polymers for the carrier layers and central barrier layer and then arranging them according to Usui’s b/a/b sequence (¶ [0089]).
Usui selects commercially available polymers and simplifies the construction of film laminate. Usui’s laminate may comprise between 2-7 layers (¶ [0089]). One would be motivated to modify Nishtala with Usui’s single PVC or PUR carrier layer to use easily obtained polymers and also since Usui produces the laminate as an intermediate step in constructing a tube or bag (¶ [0096], As required, the resulting multilayer structure may be subjected to … bag forming process, deep drawing process, box forming process, tube forming process). Therefore, it would have been obvious to modify Nishtala with Usui’s various layers and materials in order to use commercially available polymers which can be formed into a tube or bag.
Regarding claims 20-22, 37 and 38, Nishtala lacks a PA, PUR or PE-based layer. Usui discloses a film laminate wherein at least one barrier layer is made of EVOH and, is joined to a neighboring layer made of PA (¶ [0089] Where EVOH resin composition layers a (a1, a2, . . . ) … and base resin layers b (b1, b2, . . . ) … the multilayer structure may be any combination of these layers, e.g., a/b, b/a/b, a/b/a, a1/a2/b, a/b1/b2, b2/b1/a/b1/b2, b2/b1/a/b1/a/b1/b2, or the like);
wherein at least one carrier layer is made of PUR and, is joined to a neighboring layer made of PA (¶ [0089] Where EVOH resin composition layers a (a1, a2, . . . ) … and base resin layers b (b1, b2, . . . ) … the multilayer structure may be any combination of these layers, e.g., a/b, b/a/b, a/b/a, a1/a2/b, a/b1/b2, b2/b1/a/b1/b2, b2/b1/a/b1/a/b1/b2, or the like);
wherein a layer made of PA is joined to a PE-based layer (¶ [0087] Examples of the base resin include: (unmodified) polyolefin resins including polyethylene resins such as linear low-density polyethylenes, low-density polyethylenes, very-low-density polyethylenes, medium-density polyethylenes, high-density polyethylenes, ethylene-propylene (block and random) copolymers);
by use of an adhesion promoter as an intermediate layer (¶ [0091] Where the adhesive resin layers are provided between the EVOH resin composition layer formed from the EVOH resin composition of the present disclosure and the base resin layers in the multilayer structure, the adhesive resin layers are present on opposite sides of the EVOH resin composition layer and, therefore, a highly hydrophobic adhesive resin is preferably used for the adhesive resin layers);
wherein a gas- and/or water vapor-tight barrier layer (34) is situated between an elastically deformable carrier layer made of PUR and a nonelastically deformable carrier layer made of PVC (¶ [0089], the layered configuration of the multilayer structure may be any combination of these layers, e.g., a/b, b/a/b, a/b/a, a1/a2/b, a/b1/b2, b2/b1/a/b1/b2, b2/b1/a/b1/a/b1/b2, or the like);
wherein the proportional wall thickness of the nonelastically deformable carrier layer (33, 35, 36, 39, 40) made of PVC, for example, is greater than the proportional wall thickness(es) of the elastically deformable carrier layer(s) made of PUR (¶ [0098] The thickness ratio between the EVOH resin composition layer and the base resin layer of the multilayer structure (EVOH resin composition layer/base resin layer) … is typically 1/99 to 50/50, preferably 5/95 to 45/55, particularly preferably 10/90 to 40/60).
Usui forms a film laminate from commercially available polymers and which is suited for constructing a tube or bag (¶ [0096]). Usui’s laminate may comprise between 2-7 layers, in addition to intermediate adhesive layers (¶ [0089], [0090], [0091], [0093]). Regarding the rationale and motivation to modify Nishtala with Usui’s layers, see the discussion of claims 1, 7-11, 13-15 and 18 above.
Regarding claim 31, Nishtala lacks a multilayer film material. Usui discloses a film laminate wherein multiple layers of the multilayer film material are thermally formed together in a subsequent manufacturing step (¶ [0093] The EVOH resin composition layer formed by using the EVOH resin composition of the present disclosure and the base resin layer may be laminated together … Of these methods, the coextrusion method is preferred; ¶ [0096], As required, the resulting multilayer structure may be subjected to heating process, cooling process, rolling process, printing process, dry laminating process, solution or melt coating process, bag forming process, deep drawing process, box forming process, tube forming process, splitting process, or the like). Regarding the rationale and motivation to modify Nishtala with Usui’s layers, see the discussion of claim 1 above.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Nishtala and Usui in view of Bracken, Ronald L. et al. (US 20030139730 A1).
Regarding claim 23, Nishtala and Usui do not explicitly adhere separate components using cyclohexanone or tetrahydrofuran. Bracken discloses an antimicrobial urine collection system (¶ [0001], [0010], [0019], [0020] A typical urine collection system for use with catheterized patients is depicted in FIG. 1);
wherein different, separately manufactured, adjacently situated components in the system including a tube and a container are adhesively bonded to one another by adhering adjacently situated surfaces of two separately manufactured components using a solvent, in particular using a solvent such as cyclohexanone or tetrahydrofuran (¶ [0044] The drainage tubing can be connected to the bag by applying a small amount of cyclohexanone to the tube; ¶ [0048] The outlet tube is applied to the bag by applying a small amount of cyclohexanone to the outlet tube).
Bracken demonstrates how to join polymeric components via solvent bonding. One would be motivated to modify Nishtala and Usui with Bracken’s solvent bonding since Nishtala calls for a system comprising a tube, balloon and container (Figs. 2A-2F, 7D, 8A). Therefore, it would have been obvious to modify Nishtala and Usui with Bracken’s solvent bonding in order to assemble Nishtala’s components with a known technique.
Claims 26-31 and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Nishtala and Usui in view of Göbel; Fred (US 20140358126 A1).
Regarding claims 26 and 28, Nishtala and Usui lack a spiral-shaped indentation. Göbel discloses a catheter system (¶ [0003], [0004], [0014], [0053] FIG. 1 shows the schematic design of a medical, catheter-like device 1);
comprising a film material (¶ [0054] The catheter device 1 includes a tubular film-like structure 2);
wherein the multilayer film material, at least in areas, is provided with a spiral-shaped indentation and/or protrusion or with multiple successive, ring-shaped, inwardly directed indentations and/or protrusions in order to assist the spontaneous straightening of the film material in question after a temporary deformation (¶ [0177], The area between the struts or stiffeners 120 can be preshaped as a thin-walled structure with a thickness of, for example, 0.2 to 0.4 mm, or, in the case of the counterwinding of a plurality of spirally or helically extending struts 120, can also be perforated as if by windows; ¶ [0194] FIG. 11d shows an embodiment with lumen-occluding deformability of the stiffening segment 25.sup.(19) by helical struts 143 which extend over the inner or outer surface of segment 25.sup.(19), and which can be arranged as a plurality of parallel turns running in the same direction at a given angular offset; ¶ [0197] FIGS. 11f to 11h show a transanal region 2.sup.(23) or a transanal stiffening segment 25.sup.(23). The transanal region 2.sup.(23) is corrugated, with annular elevations 201 and indentations 202 therebetween, alternating in an axial direction of the transanal region 2.sup.(23), and/or with helical elevations 203 and indentations 204 therebetween, alternating in an axial direction of the transanal region 2.sup.(23));
wherein the circular expansions or reductions of the multilayer film material are 1.0 to 3 mm deep (¶ [0177], The preferably helically extending struts 120 can be provided with a diameter of, for example, 0.75 to 2.0 mm).
Göbel increases a tube’s stiffness and ability to resist collapsing, while remaining flexible (¶ [0197], Such preformations of a tube-like foil 205 give the material a higher stiffness, but still allow a flexing of the transanal region 2.sup.(23), as can be seen in FIG. 11g and 11h). One would be motivated to modify Nishtala and Usui with Göbel’s spiral-shaped indentation to preserve the tube’s lumen when surrounding tissues compress it. Therefore, it would have been obvious to modify Nishtala and Usui with Göbel’s spiral-shaped indentation in order to hold the tube open against compressive forces.
Regarding claim 27, Nishtala, Usui and Göbel are silent regarding the width of the circular expansions or reductions.
The expansion width is interpreted as a result-effective variable, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation.
The expansion width affects the tube’s stretchability and ability to fit inside the patient through routine experimentation. For example, excessively narrow or wide expansions limit the tube’s stretchability and fit.
Too low
The tube will not be able to stretch sufficiently
Optimized range
The tube will be able to stretch sufficiently and also fit within the patient’s intestine
Too high
The expansions will be too bulky and will not fit comfortably in the patient’s intestine
Göbel discloses a related dimension for corrugations on the tube (¶ [0177], The preferably helically extending struts 120 can be provided with a diameter of, for example, 0.75 to 2.0 mm). This suggests that the spacing between consecutive corrugations can be optimized.
Therefore, it would have been obvious to adjust the expansion width in order for the tube to stretch adequately and also fit within the patient’s intestine. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 29 and 30, Nishtala and Usui lack separate intracorporeal and transosteal balloon segments. Göbel discloses a catheter system wherein the balloon-like element has a radially expanded, intracorporeal balloon segment and a transosteal balloon segment that is radially tapered with respect to the radially expanded, intracorporeal ballon segment (¶ [0145], The envelope 27 outwardly defining compartment 28 can further be preformed into a barbell or hourglass shape. In such a configuration, the preferably medially disposed waist 29 is preshaped to accommodate the structures of the anal canal);
wherein the entire intracorporeal portion and also the entire extracorporeal portion of the balloon like element are formed from a single, structurally continuous film tube blank (Fig. 3B, balloon envelope 27 is a continuous structure that forms waist preformation 29).
Göbel accommodates the anal canal’s shape and reduces the risk of leaking (¶ [0145], the described waist preformation 29, on the one hand, serves to securely anchor the head portion of the device and, on the other hand, helps to form a seal against irrigation fluid leaking from the rectum). One would be motivated to modify Nishtala and Usui with Göbel’s intracorporeal and transosteal balloon segments to more effectively interface the system with the patient’s intestines. Therefore, it would have been obvious to modify Nishtala and Usui with Göbel’s intracorporeal and transosteal balloon segments in order to form a better seal with the patient’s intestine.
Regarding claims 34-36, Nishtala and Usui do not explicitly disclose invaginated indentations or channel-like formations. Göbel discloses a catheter system wherein during the in situ placement of a residual balloon body typical invaginated indentations of the excess, residual balloon envelope form in the balloon interior (¶ [0127] FIG. 1c shows a funnel element 3; ¶ [0128], Furthermore, the outer surface 210 and/or the inner surface 211 can comprise indentations 213, for example in the form of smooth, longitudinal troughs extending in an axial direction … Therefore, if necessary, the funnel element 3 can fold together along the indendations 213, for example during the application of the device into the rectum of a patient);
wherein the indentations that are invaginated in the balloon interior have turned-over formations with an eyelet-like cross section, which preferably extend or continue as channel-like formations in the longitudinal direction of the balloon (¶ [0128], Therefore, if necessary, the funnel element 3 can fold together along the indendations 213, for example during the application of the device into the rectum of a patient).
Nishtala, Usui and Göbel are silent regarding the dimensions and filling pressure of the channel-like formations and balloon. However, these parameters are interpreted as result-effective variables since they can be optimized. For example, the channels are configured to appear when the balloon compresses inside the patient’s rectum. Therefore, the channels must be accommodated within the difference between the balloon’s expanded and compressed states. The inflation pressure must fall within a safe range that will not injure the patient. A skilled artisan would have been able to modify these parameters so that the balloon can fit within the patient’s rectum and avoid injuring the patient.
Göbel configures a balloon to more easily compress in a patient’s rectum and to expand when pressurized (¶ [0128], Such indendations 213 reduce the stiffness of the funnel element 3, especially along their longitudinal axes. Therefore, if necessary, the funnel element 3 can fold together along the indendations 213, for example during the application of the device into the rectum of a patient. Inside the rectum of a patient, the funnel element 3 expands due to its self-erecting properties). One would be motivated to modify Nishtala and Usui with Göbel’s invaginated indentations so that the balloon can compress and expand to a greater degree. Therefore, it would have been obvious to modify Nishtala and Usui with Göbel’s invaginated indentations in order to expand the balloon’s expansion range.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Nishtala and Usui in view of Oberholtzer; Gary et al. (US 20170042723 A1).
Regarding claim 32, Nishtala discloses a system comprising an extracorporeal, stool-discharging tube segment provided with lumen-stabilizing indentations and/or protrusions and an intracorporeal balloon (¶ [0066] FIGS. 2C-2E illustrate embodiments of the rectal section 18 with a retention cuff 24 and a collection member 32. FIG. 2C is similar to FIG. 2A, including a collection member 32 … FIG. 2D shows a cuff 24d with a geometry that more gradually transitions to the body … FIG. 2E shows cuff 24d surrounding a collection member 32e that has a trumpet-shaped configuration; ¶ [0077] In one embodiment, the sphincter section 20 includes a sealing feature, such as a plurality of ribs arranged about the perimeter thereof; ¶ [0089], In one embodiment, the extracorporeal section 22 includes one or more stiffening structures, such as inflatable ribs, metal wires or ribbons, axially positioned rings, etc., to assist in preventing collapse of the lumen 34).
Nishtala an Usui lack a hot-molding process. Oberholtzer discloses an ostomy appliance (¶ [0002], [0003], [0026], [0052] Referring to FIGS. 1-2, an ostomy appliance 10);
comprising a multi-layer film (¶ [0054] The front, rear, and center panels 11, 12, and 13 … A suitable film includes, for example, a laminate of one or more layers of ethylene vinyl acetate (EVA), and one or more layers of a gas barrier material, such as poly(vinylidene chloride) (PVDC));
wherein multiple layers of the multilayer film material are thermally formed together in a subsequent manufacturing step (¶ [0035], [0036], In some embodiments, the one or more protrusions may be made of the same material as the front panel and shaped for example, by thermoforming).
Oberholtzer constructs an ostomy appliance with a known method. Thermoforming and vacuum forming are common techniques for applying textures to a plastic film. One would be motivated to modify Nishtala and Usui with Oberholtzer’s hot-molding process since Nishtala calls for a plastic film that is shaped into various parts of a waste collection system (¶ [0063], For example, the collection member may be made from a material selected from polyurethane, silicone rubber, natural rubber latex, synthetic rubber, guayule rubber, 80 SH polydimethylsiloxane, fumed silica, polyvinyl chloride (PVC), and combinations thereof; ¶ [0089], For example, in one embodiment, the extracorporeal section is made from a rubber or plastic material). Therefore, it would have been obvious to modify Nishtala and Usui with Oberholtzer’s hot-molding process in order to construct a waste collection system with a known technique.
Claims 41-46, 48-49, 53-55, 63-65 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Nishtala and Usui in view of Glithero; Jason Iain et al. (US 20180303655 A1).
Regarding claims 41-46, 48-49, 53-55, 63-65 and 67, Nishtala and Usui lack a degassing device connected to a compartment. Glithero discloses a vent adaptor assembly (¶ [0006], [0026] FIG. 1 is a top plan view of a urinary drainage bag system 100 including a vent adaptor assembly 102,);
comprising a tube and a container (¶ [0027] The urinary drainage bag system 100 includes a drainage bag 104 that is fluidly coupled to a catheter 106 (e.g., urinary catheter) via a drainage tube 108; ¶ [0036] FIGS. 2A and 2B … a vent adaptor assembly 202 including a vent 210);
wherein a branch that is used as an outlet is provided in a conducting area for conducting the substances to be delivered and/or discharged (¶ [0040], the drainage body 222 includes a vent wall 242 that at least partially defines the vent opening 228 … the vent wall 242 exhibits a generally cylindrical shape that extends outwardly from the drainage body 222);
wherein the adsorption and/or absorption and/or filter device is integrated with the branch or connected to same (¶ [0044] The vent 210 includes at least one of a filter 232, a retention member 230, or a cap 234);
wherein the adsorption and/or absorption and/or filter device is situated spatially separate from the delivering and/or discharging lumen of the system via a protected access path in the branch, so that the degassing device having an adsorbent or filtering action is protected from direct exposure to the substances to be delivered and/or discharged (¶ [0045] The filter 232 is formed and structured from a material that is substantially impermeable to a selected liquid (e.g., urine, water), while being at least partially permeable (e.g., substantially permeable) to gas (e.g., air) … The porous polymer film may be at least partially formed from PTFE, silicone, another hydrophobic material, or combinations thereof);
wherein the branch is situated distally with respect to a return-inhibiting element at the inlet of the compartment in the container (¶ [0071] The flow regulator 576 may include any suitable valve that is configured to regulate fluid flow through the drainage lumen 525 … Alternatively, the flow barrier 578 may include … any other suitable flow barrier (e.g., a check valve, a diaphragm valve, a gate valve, etc.); ¶ [0080] FIG. 6 is an isometric cutaway view of a vent adaptor assembly 602 that includes a vent 610 and a flow regulator 676, ¶ [0082] The flow regulator 676 may include an actuator 682 indirectly coupled to a flow barrier 678 … For example, the flow barrier 678 may be structured and function similar to or the same as the flow barrier 578 shown in FIGS. 5A-5C);
wherein the return-inhibiting element has film-based, lip-like, or sail-like components, the distance between the film-based, lip-like, or sail-like components in the main flow direction (¶ [0071], Alternatively, the flow barrier 578 may include … any other suitable flow barrier (e.g., a check valve, a diaphragm valve, a gate valve, etc.). The flow barrier 578 may be movable between the first position and the second position);
wherein the adsorption and/or absorption and/or filter device is spaced apart from the conducting area, at least in areas, to avoid, to the greatest extent possible, intensive contact with the substances flowing through the conducting area (Figs. 2B, 4B, 6, vents 210, 410, 610 extend vertically away from the main lumen in their respective drainage bodies 222, 422, 622);
wherein the maximum flow cross section in the area between the branch and the adsorption and/or absorption and/or filter device is equal to or less than the minimum flow cross section in the conducting area (Figs. 2B, 4B, 6, vents 210, 410, 610 present a generally smaller cross-section than the main lumen in their respective drainage bodies 222, 422, 622);
wherein the flow cross section in the area between the branch and the adsorption and/or absorption and/or filter device is narrowed with respect to the minimum flow cross section in the conducting area via an obstruction (¶ [0040], retention member 230; ¶ [0047] The retention member 230 may be configured to at least substantially cover the vent opening 228; ¶ [0048] The retention member 230 may define one or more apertures 252 … The one or more apertures 252 exhibits a shape and size configured to allow air to flow therethrough, while preventing the filter 232 from being able to pass therethrough);
wherein the inlet opening of the adsorption and/or absorption and/or filter device facing the conducting area or the branch is covered by a gas-permeable, but water-repellent, separating layer; wherein the separating layer has a slightly wettable surface (lotus effect); wherein the separating layer is made of a paper, in particular a nonwoven paper, or is designed as a microporous membrane made of expanded polytetrafluoroethylene, for example, preferably having a maximum pore diameter of less than 1 mm, preferably having a maximum pore diameter of 100 μm or less, in particular having a maximum pore diameter of 10 μm or less (¶ [0045] The filter 232 is formed and structured from a material that is substantially impermeable to a selected liquid (e.g., urine, water), while being at least partially permeable (e.g., substantially permeable) to gas (e.g., air) … The porous polymer film may be at least partially formed from PTFE, silicone, another hydrophobic material, or combinations thereof; ¶ [0055], the method 300 may be modified such that the filter 232 comprises a material other than a sintered porous PTFE film (e.g., a silicone, a stretched PTFE film));
wherein the adsorption and/or absorption and/or filter device is situated in a replaceable cartridge or in a cap-like closure (¶ [0044], The vent 210 may further include a cap 234 configured to be removably attached to at least one of the drainage body 222 or the vent 210);
wherein the replaceable cartridge or the cap-like closure is provided with one or more outlet openings in the area of its free end-face side or its circumference (¶ [0048] The retention member 230 may define one or more apertures 252 formed therein);
wherein the replaceable cartridge or the cap-like closure is connectable to the conducting area at the branch (¶ [0051] The cap 234 may be reversibly attached to the vent 210 in any suitable manner … using a weak adhesive, a threaded attachment, or an interference fit or snap fit with the retention member 230 and/or the vent wall 242 … a magnet or a magnetically-attractable material);
wherein the conducting area including the branch is integrated with the tube or the bag (Figs. 2B, 4B, 6, vents 210, 410, 610 are integrated with the main lumen in their respective drainage bodies 222, 422, 622).
Glithero demonstrates how to add an odor and particulate filter to a cylindrical tube or container. One would be motivated to modify Nishtala and Usui with Glithero’s degassing device, compartment and replaceable cartridge since Nishtala calls for a filter but does not illustrate any of its details (¶ [0086]). Therefore, it would have been obvious to modify Nishtala and Usui with Glithero’s degassing device, compartment and replaceable cartridge in order to filter gases from a waste collection system.
Claims 50-52 are rejected under 35 U.S.C. 103 as being unpatentable over Nishtala, Usui and Glithero in view of Lenz; Morten et al. (US 5690623 A).
Regarding claims 50-52, Nishtala, Usui and Glithero lack an obstruction designed as a tongue. Lenz discloses a vented ostomy pouch (col. 1, lines 30-35; col. 2, lines 50-55, FIGS. 1-5, the numeral 10 generally designates an ostomy pouch);
comprising a filter (col. 3, lines 30-40, A flat pad-like deodorizing gas filter 22 is secured to the inside surface of wall 12 over opening 21 so as to deodorize gases exiting the pouch through the opening);
wherein an obstruction is designed as a tongue that is situated within a conducting area approximately at the height of a branch; wherein the obstruction is designed as a tongue that is articulated distally with respect to the branch, and that covers the branch, at least in areas, for the adsorption and/or absorption and/or filter device with respect to the conducting area when substances are conducted (col, 4, lines 5-15, A filter-protecting panel 30 is located in the upper portion of the second chamber 25 between walls 12 and 13 … Gases passing into the second chamber through vents 26 must therefore travel downwardly and then upwardly to reach filter 22 and outlet 21);
wherein the tongue has a flexible and/or elastic design, and/or is made of plastic (col. 4, lines 5-15, The panel may be formed of the same material as walls 11-13).
Lenz deflects waste materials from a filter (col. 4, lines 5-15, Gases passing into the second chamber through vents 26 must therefore travel downwardly and then upwardly to reach filter 22 and outlet 21. Any liquids traveling into the second chamber through the vents is therefore directed downwardly and is not likely to reverse direction and reach the filter and outlet opening). A skilled artisan would have been able to modify Nishtala, Usui and Glithero with Lenz’s tongue obstruction by installing a plastic flap upstream of the filter. One would be motivated to modify Nishtala, Usui and Glithero with Lenz’s tongue obstruction to reduce the amount of material that contacts the filter and to thereby minimize fouling at the filter. Therefore, it would have been obvious to modify Nishtala, Usui and Glithero with Lenz’s tongue obstruction in order to prevent waste materials from fouling the filter.
Claims 56-59, 61 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Nishtala and Usui in view of Jensen; Ole R. (US 4451258 A).
Regarding claims 56-59, 61 and 62, Nishtala and Usui do not explicitly disclose surface-active adsorbent substances, lamella-like structures or a granulate. Jensen discloses an adsorption and/or absorption and/or filter device having one or more surface-active adsorbent substances that accumulate odorous substances on the surface, and/or one or more absorbent substances that absorb the odor-effective materials in the manner of a physical solution; wherein the adsorption and/or absorption and/or filter device includes a material that filters odor-causing substances, in particular in the area of its downstream or outlet-side opening; wherein the adsorption and/or absorption and/or filter device includes a material that filters infectious pathogens, in particular in the area of its downstream or outlet-side opening; wherein the adsorption and/or absorption and/or filter device (25) includes an adsorbent or absorbent or filtering granulate (col. 3, lines 10-25, the deodorizing filer 28, which can be manufactured from a piece of porous cloth saturated with perfume or a sheet of foam embedded with particles of activated carbon);
wherein the adsorption and/or absorption and/or filter device in its interior has one or more lamella-like structures in order to lead the gas to be cleaned through the adsorption and/or absorption and/or filter device, preferably multiple lamella-like structures being offset relative to one another and/or meshing into one another in the manner of interlocked fingers (col. 3, lines 45-55, An inner side 43 of the lid 24 is provided with a pair of concentric rings 44 (see FIG. 2). When the lid 24 is in its closed position, the rings 44 project into the interior chamber 26 of the housing 18 so that the ring 36 on the base 22 is positioned between the rings 44. The ring 36 cooperates with the rings 44 to impart a corrugated shape to the normally flat filter 28 (see FIG. 2), whereby the gas flowing through the housing 18 will be forced to pass through and over the filter 28 many times before being discharged to the atmosphere).
Jensen removes odorous substances from gases as they pass through a waste collection system, and prevents them from entering the local atmosphere (col. 4, lines 30-35, As the air or gas flows along this flow path, it is forced to repeatedly pass over and through the filter 28 housed in the interior chamber 26 of the housing 18, whereby the air or gas is deodorized prior to its discharge to the atmosphere). One would be motivated to modify Nishtala and Usui with Jensen’s activated carbon, granulate or lamella-like structures since Nishtala calls for a filter but does not illustrate any of its details (¶ [0086]). Therefore, it would have been obvious to modify Nishtala and Usui with Jensen’s activated carbon or lamella-like structures in order to filter gases from a waste collection system.
Claim 60 is rejected under 35 U.S.C. 103 as being unpatentable over Nishtala, Usui and Jensen in view of Patchett; Kim (US 20160228283 A1).
Regarding claim 60, Nishtala, Usui and Jensen lack a spiral structure. Patchett discloses a filter device having at least one screw-shaped, spiral, and/or helical structure in order to lead the gas to be cleaned through the adsorption and/or absorption and/or filter device (¶ [0084], The filter path 18 shown in FIG. 5 is elongate … the filter path 18 can be made even longer by curving the filter path 18 (see FIG. 8), and made even longer still by spiralling the filter path 18 (see FIG. 9)).
Patchett extends a filter path in order to more thoroughly expose gases inside a filter (¶ [0084], This provides a long path over which the flatus gas can be filtered). One would be motivated to modify Nishtala, Usui and Jensen with Patchett’s spiral structure to remove more odor-causing substances from gases when they pass through the filter. Therefore, it would have been obvious to modify Nishtala, Usui and Jensen with Patchett’s spiral structure in order to more thoroughly filter gases through a filter.
Response to Arguments
The objections to the claims for minor informalities, the rejection of claim 1 under 35 USC § 101 and the rejections of claims 1-68 under 35 USC § 112 are withdrawn in view of the amendments filed 16 April 2026.
The objections to Fig. 15 for a misnumbered element “27” is withdrawn in view of the amendments filed 16 April 2026. The revised drawings have been accepted.
Applicant’s arguments filed 16 April 2026 regarding the rejection of claims 1-5, 7-65 and 67-68 as amended, under 35 USC § 103 over Nishtala, Bekele, Quacquarella, Hatanaka, Bracken, Gobel, Oberholtzer, Glithero, Lenz, Jensen and Patchett, have been fully considered and are persuasive. After further consideration, the amended claims are rejected on new grounds under 35 USC § 103 over Nishtala, Usui, Bracken, Gobel, Oberholtzer, Glithero, Lenz, Jensen and Patchett (see above).
Applicant’s arguments regarding Bekele, Quacquarella and Hatanaka have been considered but are moot because the references are no longer cited in the current rejection.
As a preliminary matter, Applicant notes that claim 1 has been amended to include the subject matter of claim 6 (remarks p. 15). Examiner finds that amended claim 1 incorporates portions of former claim 6 and also deletes the option of polyolefin-based polymers.
Applicant asserts that accordingly, Nishtala discloses that tubular body 12, that includes an extracorporeal section 22, is made of silicone (remarks p. 16). Applicant contends that Bekele does not disclosure a multilayered film material including at least one barrier layer of EVOH and/or PVDC and at least one carrier layer of PUR, TPU, PVC, PA, TPE-A, or combinations thereof (remarks p. 17). Examiner acknowledges that Nishtala lacks a multilayer film material and that Bekele fails to remedy Nishtala’s deficiencies.
Examiner responds that Nishtala and Usui are cited in the new grounds of rejection as teaching all features of amended claim 1. Usui explicitly discloses a multilayer film material including a carrier layer comprising PUR, PVC or PA (¶ [0087]).
Applicant submits that as noted above, Bekele is related to medical packaging, particularly for ostomy applications. Packaging serves to permanently contain a packed substance, whereas the system recited in amended claim 1 serves only to temporarily transmit a substance (remarks p. 18). Applicant asserts that even if the person the person of skill in the art were to combine the film of Bekele, which Applicant does not concede, they would only replace the waste container of Nishtala with the packing material of Bekele, and not the tubing. But even if the person of skill in the art were to modify the water container of Nishtala, they still would not arrive at the amended claim as Bekele does not disclose the claimed multilayered film material, as described above (remarks p. 19).
Examiner replies that Usui is cited in the new grounds of rejection as teaching a multilayer film material, which is suitable for packaging and also other applications including a tube or bag (¶ [0096], [0099]). Usui also forms a silage container or multilayer pipe from the laminate (¶ [0006], [0099], [0101], [0104]). Usui’s multilayer material appears suitable for any conduit, pipe or bag which requires a durable and odor-resistant material. Usui demonstrates that the material can be reshaped into these articles by adjusting the material’s thickness (¶ [0097] The thickness of the multilayer structure … vary depending upon the layered configuration, the type of the base resin, the type of the adhesive resin, and the use purpose, the package shape, the required physical properties, and the like of the multilayer structure. The thickness of the multilayer structure … is typically 10 to 5,000 μm).
Applicant reasons that thus, the person of skill in the art would not arrive at the claimed invention which requires both the tubular film-like structure and the film-based components of the container be made of a multiplayer film material (remarks p. 19). Examiner responds that Usui calls for adjusting the material’s thickness according to its intended application (¶ [0097]). A skilled artisan would have been able to modify Nishtala, with Usui’s multilayer material by constructing Nishtala’s tubular film-like structure and container from Usui’s laminate, and adjusting its thickness as needed.
Applicant contends that Quacquarella, Hatanaka, Bracken, Globel, Oberholtzer, Glithero, Jenson, and Patchett do not remedy the deficiencies of Nishtala and Bekele (remarks p. 19). Examiner notes that Gobel, Oberholtzer, Glithero, Lenz, Jensen and Patchett are cited as teaching features of dependent claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kim; Hong Suk et al. KR 20180000892 A
Nishiura; Katsunori et al. US 20110033716 A1
Nishikawa; Takeshi US 20210163777 A1
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 extension fee 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 date of this final action.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights