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.
Election/Restrictions
Applicant's election with traverse of species D in the reply filed on 15 September 2025 is acknowledged. The traversal is on the ground(s) that claim 1 of the present application does not recite a “degassing device” (remarks p. 3). This is not found persuasive because claims 39, 40 and 43 call for a degassing device. This feature is included in the discussion for completeness and because the invention as a whole includes a degassing device, as demonstrated in Fig. 1.
Applicant contends that furthermore, the Examiner has failed to consider the special technical feature of a “tubular film-like structure (2) of the system and the film-based components … made of a robust, mechanically loadable material” (remarks p. 3). Examiner responds that Nishtala; Vasu (US 20110282311 A1) further discloses a tubular structure (¶ [0062], FIG. 1A, a waste management system 10 includes a waste transport device, including a generally tubular body (e.g., catheter) 12 … extracorporeal section 22).
Applicant submits that however, the Examiner has failed to provide any evidence that the prior art discloses, inter alia, the special technical feature of a tubular film-like structure and film-based components of a container that are made of multilayer film material which in each case includes at least one barrier layer (34), made of ethylene-vinyl alcohol copolymer (EVOH) and/or polyvinylidene chloride (PVDC) (remarks p. 3-4). Examiner responds that Nishtala further describes various polymers that are formed into portions of the tubular structure (¶ [0063] With reference to the rectal section 18 of the body 12, shown in FIGS. 2A-2B, the collection member 32 … 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; ¶ [0075] With further reference to the embodiment shown in FIGS. 2A-2B … In one embodiment, the sphincter section 20 is made from a material selected from polyurethane, silicone rubber, natural rubber latex, synthetic rubber, 80 SH polydimethylsiloxane, fumed silica, polyvinyl chloride (PVC), and combinations thereof).
More particularly, Applicant avers that a barrier is a completely different element than a filter (remarks p. 4). Examiner responds that Nishtala discloses other polymers including polyurethane, silicone rubber, natural rubber latex, synthetic rubber, guayule rubber, 80 SH polydimethylsiloxane, fumed silica or polyvinyl chloride (PVC) (¶ [0063], [0075]).
It is further noted that the feature of a barrier layer “made of ethylene-vinyl alcohol copolymer (EVOH) and/or polyvinylidene chloride (PVDC)”, which may also be considered a special technical feature of independent claim 1 (and hence, a special technical feature of all of the claims depending from independent claim 1) is also not alleged by the Examiner to be shown in the prior art (remarks p. 5-6).
Examiner acknowledges that Nishtala does not explicitly disclose EVOH and/or PVDC. However, Fattman; George et al. (US 20110213321 A1) discloses an ostomy device comprising a film container including odor barrier polymers (¶ [0043] The ostomy pouch 32 generally comprises a rear wall 36 and a front wall 38. The front and rear walls 36, 38 are made of flexible plastic films that are generally impermeable to liquid and gas. A suitable film includes, for example, a laminate of one or more layers of ethylene vinyl acetate (EVA), and one more layers of a gas barrier material, such as poly(vinylidene chloride) (PVDC) or poly(vinylidene fluride) (PVDF)).
In a second example, Oberholtzer; Gary et al. (US 20170042723 A1) discloses a film container including odor barrier polymers (¶ [0054] The front, rear, and center panels 11, 12, and 13 may be made of flexible plastics film that is generally impermeable to liquid and gas. 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)).
Fattman and Oberholtzer demonstrate that film-based components made of multilayer film and including at least one odor barrier layer made of EVOH and/or PVDC is known in the art. A skilled artisan would have been able to modify Nishtala with Fattman’s or Oberholtzer’s odor barrier polymers by constructing Nishtala’s tube from multiple layers including the cited odor barrier polymers.
The requirement is still deemed proper and is therefore made final.
Claims 1-68 are examined on their merits as reading on the elected species D.
Claim Objections
Throughout the claims, the language “… [[characterized in that]] wherein …” should be revised for brevity.
In claim 1, the language “… [[characterized in that]] wherein the [[delivering and/or discharging,]] tubular film-like structure (2) of the system and the film-based components of the container …” should be changed for clarity.
In claim 3, the language “… characterized in that the [[(]] overall [[)]] thickness d.sub.T of the carrier layer or of all carrier layers is greater than the [[(]] overall [[)]] thickness d.sub.B of the barrier layer …” should be changed for clarity. The parenthesis do not appear to add any meaning to the claim.
Claim 4 also includes extraneous parenthesis and should be revised similarly.
In claim 23, the phrases “… on the one hand … on the other hand …” should be revised to avoid informal language.
In claim 26, the phrase “…of the film material [[in question]] after a temporary deformation.” should be revised to avoid informal language.
Claim 29, calls for “… that is radially tapered with respect to same.” This language should be revised to explicitly recite the relationship between the balloon segments.
In claim 43, the language “… so that the degassing [[unit]] device having an adsorbent or filtering action is protected from …” should be changed for clarity.
In claim 46, the language “… is spaced apart from the conducting area, at least in areas, to [[avoid, to the greatest extent possible,]] minimize intensive contact with …” should be changed for brevity.
In claim 66, the language “… characterized in that the conducting area including the branch, and/or the replaceable cartridge (254) [[[sic; (25a)] ]] and/or the removable cap, has …” should be changed to delete draft versions of the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-68 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 1 calls for “… comprising a head unit (5) that is positionable in an interior space of the body of the patient, includes a balloon-like element (3), and [[retains and/or seals]] configured to retain and/or seal the system in the body of the patient…” which should be revised to remove the patient’s body from the claim scope.
Applicant is recommended to use inferential language (e.g. configured to, adapted to or whereby) to avoid positively claiming the human body.
Claims 2-68 are rejected for depending on a rejected parent claim.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 63-67 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 63 calls for “…is situated in a replaceable cartridge (25a) or in a removable cap.” The specification describes an embodiment comprising a cap (¶ [0083] FIG. 18 … The end face-side opening of the leg 29 is provided with a cap-like closure that has openings 25a for the release of gas to the surroundings). However, the specification does not describe whether the cap is removable or permanently joined to the leg 29.
Claim 64 also calls for “…the removable cap …” which does not appear in the specification.
Claim 65 calls for “…characterized in that the replaceable cartridge (25a) or the removable cap is connectable to the conducting area at the branch at that location via a bayonet lock or via a screw closure.” The specification describes an embodiment comprising a cap (¶ [0083] FIG. 18 … The end face-side opening of the leg 29 is provided with a cap-like closure that has openings 25a for the release of gas to the surroundings). However, the specification does not describe a bayonet lock or via a screw closure.
Claim 66 calls for “…characterized in that the conducting area including the branch, and/or the replaceable cartridge (254) [sic; (25a)] and/or the removable cap, has at least one compartment for accommodating a fragrance.” The specification describes an embodiment comprising a cap (¶ [0083] FIG. 18 … The end face-side opening of the leg 29 is provided with a cap-like closure that has openings 25a for the release of gas to the surroundings). However, the specification does not describe any compartment for accommodating a fragrance.
Claim 67 is rejected for depending on a rejected parent claim.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-68 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 calls for “…an extracorporeal container (11) including a preferably film-based, bag-like compartment …” This language is ambiguous because it does not clearly specify whether the container comprises a film or not.
Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. See MPEP 2173.05(c) and (d).
Claims 5-7, 16-18, 20, 21, 23, 28, 31, 32, 34-37, 39, 45, 47, 52-55, 57-59, 61 and 62 also recite “preferably, of a type, in particular, for example, such as, i.e. or typical” language and should be revised similarly.
Claim 1 calls for “… are made of multilayer film material which in each case includes at least one barrier layer (34), made of ethylene-vinyl alcohol copolymer (EVOH) and/or polyvinylidene chloride (PVDC), that acts as an odor barrier, and in each case at least one carrier layer (35, 37, 39, 49) made of a robust, mechanically loadable material.” This language is ambiguous because it does not specify or imply other cases. Examiner suggests to revise this claim to focus only on the features of the claimed embodiment.
Claim 2 recites similar “in each case” language and should be revised likewise.
Claim 4 calls for multiple ranges of the relationship between dT and dB, which render the claim indefinite.
Use of a narrow numerical range that falls within a broader range in the same claim may render the claim indefinite when the boundaries of the claim are not discernible. Description of examples and preferences is properly set forth in the specification rather than in a single claim. A narrower range or preferred embodiment may also be set forth in another independent claim or in a dependent claim. See MPEP 2173.05(c).
Claim 28 calls for multiple ranges of the circular expansions or reductions, which render the claim indefinite.
Claim 24 calls for “…the balloon and the line are made of the same multilayer film material, and/or the container and the line are made of the same multilayer film material, and/or the balloon, the container, and the line are made of …” There is insufficient antecedent basis for this limitation in the claim. Instances of “the line” have been interpreted as the “tubular film-like structure.”
Claim 29 calls for “…characterized in that the catheter balloon has a radially expanded …” There is insufficient antecedent basis for this limitation in the claim, since parent claim 1 does not recite a catheter.
Claim 30 calls for “…characterized in that the entire intracorporeal portion and also the entire extracorporeal portion of the catheter balloon are …” There is insufficient antecedent basis for these limitations in parent claim 1. This claim should be amended to depend on claim 29.
Claim 33 calls for “…characterized in that the catheter-like structure is insertable into …” There is insufficient antecedent basis for this limitation in the claim.
Claim 47 calls for “…characterized in that the longitudinal direction of the flow channel between the branch (29) and the adsorption and/or absorption and/or filter device, with respect to the longitudinal direction of the conducting area between …” There is insufficient antecedent basis for these limitations in the claim. This claim should be amended to depend on claim 41.
Claim 48 calls for “…characterized in that the maximum flow cross section in the area between the branch (29) and the adsorption and/or absorption and/or filter device (25) is equal to or less than the minimum flow cross section in the conducting area.” There is insufficient antecedent basis for these limitations in the claim. This claim should be amended to depend on claim 41.
Claim 68 calls for “…is integrated with or connectable to the catheter (5), which is …” There is insufficient antecedent basis for this limitation in the claim.
The remaining dependent claims are rejected for depending on a rejected parent claim.
Drawings
The drawings are objected to because in Fig. 15, element “7” should be changed to “27” to properly identify the separating layer 27 (¶ [0080], In the area of the connection of the filter module 25, the base element 24 has one or more openings 26 that are adjoined by a gap-shaped intermediate space 26a which points toward the adsorbent or filtering material, and which is delimited by a separating layer 27 that is impermeable to water but permeable to gas); .
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 1-6, 12, 16-17, 19, 24-25, 33, 39-40, 47, 57 and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Nishtala; Vasu (US 20110282311 A1) in view of Bekele; Solomon (US 20110125114 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 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, and retains and/or seals the system in the body of the patient (¶ [0062], a rectal section 18 … a retention cuff 24);
an extracorporeal container including a preferably 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 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 and an odor barrier layer made of EVOH and/or PVDC. Bekele discloses noise dampening films having gas and odor barrier properties (¶ [0001], [0002], [0006], [0018], Films in accordance with the present invention can be used to form a variety of packaging structures including pouches, bags, satchels and the like);
comprising a tubular film-like structure
wherein the tubular film-like structure is made of multilayer film material which includes at least one barrier layer, made of ethylene-vinyl alcohol copolymer (EVOH) and/or polyvinylidene chloride (PVDC), that acts as an odor barrier (¶ [0031] Suitable materials from which the interior layer may be selected include poly(ethylene/vinyl alcohol) (EVOH), poly(vinyl alcohol) (PVOH), polyacrylonitrile (PAN), polyesters such as polyethylene terephthalate (PET), and polyethylene naphthalate (PEN), and their copolyesters, polyvinyl chloride (PVC and its copolymers), polyvinylidene chloride (PVDC and its copolymers); ¶ [0032] Although ethylene/vinyl alcohol copolymer is not as flexible as the other listed materials, it may nevertheless be useful in certain applications; ¶ [0033] FIG. 2 illustrates another embodiment of the invention in which a seven-layer film 20 is provided that is also particularly useful in ostomy pouch applications in which one of the layers of the film is a quiet layer … Interior layer 26 may be a functional or core layer as discussed above); and
at least one carrier layer made of a robust, mechanically loadable material (¶ [0024], film 10 includes at least one exterior layer comprising an ethylene acrylate copolymer. In an exemplary embodiment, the first and second exterior layers 12, 14 of the film are both quiet layers and comprise a blend of an ethylene acrylate copolymer and a SVSPI polymer; ¶ [0033] FIG. 2 illustrates another embodiment … an RF sealable film in which exterior layers 22, 24 … Interior layer 26 may be a functional or core layer … Interior layers 28a and 28b … Adhesive or tie layers 30a, 30b).
Bekele demonstrates how to construct a durable film that blocks odors and also has a high RF seal peel strength (¶ [0025], [0028], RF seals having peel strengths on the order of 500 g/in or greater; ¶ [0030], oxygen-barrier functionality, strength, RF sealability, or melt strength. In addition, the interior layer can serve to reduce the cost of the film by allowing less material to be used in the other layers of the film structure). One would be motivated to modify Nishtala with Bekele’s multilayer film and its EVOH or PVDC odor barrier layer 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 Bekele’s laminated film and EVOH or PVDC odor barrier layer in order to block odors and provide a durable film.
Regarding claims 2-6, 12, 16-17 and 19, Nishtala does not explicitly disclose a multilayer film comprising barrier and carrier layers. Bekele discloses a system wherein the film-based tube components and/or balloon components of the head unit positioned in the interior space of the body are also made of multilayer film material which in each case includes at least one barrier layer, made of ethylene-vinyl alcohol copolymer (EVOH) and/or polyvinylidene chloride (PVDC), that acts as an odor barrier (¶ [0031], [0032], [0033], Interior layer 26 may be a functional or core layer as discussed above); and
in each case at least one carrier layer made of a robust, mechanically loadable material (¶ [0024], [0033]);
wherein the overall thickness dT of the carrier layer or of all carrier layers is greater than the overall thickness d.sub.B of the barrier layer or of all barrier layers: dT>dB (Fig. 2 shows a plurality of layers 22, 28, 30 which are thicker than interior layer 26);
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 d.sub.B of the barrier layer or of all barrier layers: dT ≥ 5 * dB (Fig. 2 shows a plurality of layers 22, 28, 30 which are approximately five times thicker than interior layer 26);
wherein at least one carrier layer is made of a mechanically loadable, preferably elastically deformable and elastically straightening, carrier material (¶ [0033] FIG. 2 illustrates another embodiment … exterior layers 22, 24 comprise a blend of an ethylene/alpha-olefin copolymer and an ethylene acrylate copolymer … Adhesive or tie layers 30a, 30b; ¶ [0034], interior layers 28a and 28b and each exterior layer comprise a blend of an ethylene/alpha-olefin copolymer and an ethylene acrylate copolymer);
wherein the material of a carrier layer is selected from the group comprising polyurethane (PUR), preferably thermoplastic polyurethane (TPU), polyvinyl chloride (PVC), polyamide (PA), thermoplastic polyamide elastomer (TPE-A), and polyolefin-based polymers, as well as combinations of these materials (¶ [0033] FIG. 2 … exterior layers 22, 24 comprise a blend of an ethylene/alpha-olefin copolymer and an ethylene acrylate copolymer; ¶ [0034], interior layers 28a and 28b and each exterior layer comprise a blend of an ethylene/alpha-olefin copolymer and an ethylene acrylate copolymer);
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 (¶ [0024] In one embodiment, the film 10 of FIG. 1 is directed to an RF sealable film … the first and second exterior layers 12, 14 of the film are both quiet layers and comprise a blend of an ethylene acrylate copolymer and a SVSPI polymer. Interior layer 16 of the film may comprise a barrier material; ¶ [0033] FIG. 2 illustrates another embodiment of the invention in which a seven-layer film 20 is provided);
wherein the wall thickness of the multilayer film material is in a range of 10 μm to 5 mm, and/or in a range of 20 μm to 2 mm, for example in a range of 50 μm to 1 mm, preferably in a range of 50 μm to 1 mm, in particular in a range of 100 μm to 500 μm (¶ [0049] The total thickness of film 20 may range from about 25 to about 150 microns, with a range from about 50 to 100 microns being preferred);
wherein the thickness of a barrier layer is in a range of 5 to 25 μm, preferably in a range of 10 to 15 μm (¶ [0050] The interior layer 26 generally has a thickness that is from about 3 to 15 microns, with a thickness of about 5 to 10 being preferred);
wherein one or more layers of the multilayer film material are coextruded with one another (¶ [0053] The multilayer films of the present invention can be formed by cast coextrusion as a tubular film. Containers for medical applications or other end uses can be made directly from the coextruded, tubular film).
Bekele constructs a film that blocks odors and resists physical damage. Regarding the rationale and motivation to modify Nishtala with Bekele’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 line are made of the same multilayer film material, and/or the container and the line are made of the same multilayer film material, and/or the balloon, the container, and the line 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 catheter-like structure 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 structure 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, in particular odorous 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°, for example an angle of 75° or less, preferably an angle of 60° or less, in particular an angle of 45° or less, or even an angle of 30° or less (¶ [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 the 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 claim 57, Nishtala discloses that the adsorption and/or absorption and/or filter device includes an adsorbent in a quantity of 5 mL or less. Nishtala does not disclose an adsorbent, and therefore discloses a quantity of zero, which is less than 5 mL.
Claims 7-11, 13-15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Nishtala and Bekele in view of Quacquarella; Cesare et al. (US 5989235 A).
Regarding claims 7-9, 11, 13-15 , Nishtala and Bekele lack a PVC or PUR carrier layer and a barrier layer that is joined to a carrier layer only at one side. Quacquarella discloses an ostomy bag (col. 1, lines 1-10; col. 1, lines 35-40, In FIG. 1, (1) represents the odor-barrier thermoplastic pouch);
comprising a bag-like compartment (col. 1, lines 35-40, (1) represents the odor-barrier thermoplastic pouch);
a multilayer film material including barrier layer, made of EVOH and/or PVDC that acts as an odor barrier (col. 3, lines 15-20, In one embodiment of the present invention the substrate is an odor-barrier thermoplastic material, comprising at least one layer of an odor-barrier material, such as PVdC … EVOH … PVOH and polyamides or polyamide co- or ter-polymers); and
wherein the material is made up of at least one carrier layer 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, preferably having a water absorption according to DIN ISO 62 of 2% or less (col. 3, lines 20-30, Generally these odor-barrier films comprise, besides the odor-barrier layer, at least one additional outer sealing layer. Generally polyethylenes, linear polyethylenes, ethylene-vinyl acetate copolymers, ethylene-alkyl acrylate copolymers, ethylene-alkyl methacrylate copolymers, polyurethanes or blends thereof are employed for the sealing layer);
wherein at least one carrier layer made of PVC is combined with at least one carrier layer made of PUR (col. 3, lines 1-5, Alternative adhesives that may suitably be employed include e.g. PVC plastisol adhesives and chlorinated modified polyolefin adhesives, col. 3, lines 20-30, at least one additional outer sealing layer … polyurethanes or blends thereof are employed for the sealing layer);
a carrier layer made of a robust, mechanically loadable material, wherein the at least one carrier layer is made of PVC or PUR (col. 3, lines 20-30, Generally these odor-barrier films comprise, besides the odor-barrier layer, at least one additional outer sealing layer. Generally polyethylenes, linear polyethylenes, ethylene-vinyl acetate copolymers, ethylene-alkyl acrylate copolymers, ethylene-alkyl methacrylate copolymers, polyurethanes or blends thereof are employed for the sealing layer);
wherein the at least one barrier layer of the two- or multilayer film material is joined to a carrier layer only at one side (col. 3, lines 20-30, Generally these odor-barrier films comprise, besides the odor-barrier layer, at least one additional outer sealing layer).
wherein a carrier layer made of PVC or PUR is provided at one or both sides of the central barrier layer, or 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 (col. 3, lines 1-5, Alternative adhesives that may suitably be employed include e.g. PVC plastisol adhesives and chlorinated modified polyolefin adhesives, col. 3, lines 20-30, at least one additional outer sealing layer … polyurethanes or blends thereof are employed for the sealing layer; col. 3, lines 30-45, A preferred odor-barrier thermoplastic film … comprises three layers, the outer layers comprising an ethylene-vinyl acetate copolymer, preferably with a high content of vinyl acetate units (e.g. 18 or more w. % of VA units), and the core layer being of PVdC … An alternative odor-barrier structure … is a 5-layer structure with a PVdC core layer, polyethylene skin layers and intermediate tie layers).
Quacquarella selects commercially available polymers and simplifies the construction of an ostomy bag film. Quacquarella’s laminate may comprise between 2-5 layers (col. 3, lines 15-45). One would be motivated to modify Nishtala and Bekele with Quacquarella’s single PVC or PUR carrier layer to use easily obtained polymers and also since Quacquarella’s polymers are suitable for RF welding (col. 3, lines 25-30, polar copolymers and particularly ethylene-vinyl acetate copolymers and polyurethanes, are normally preferred because they are sealable also by Radio Frequency which is a sealing method widely used in this area). Therefore, it would have been obvious to modify Nishtala and Bekele with Quacquarella’s single PVC or PUR carrier layer in order to use commercially available polymers which can be welded easily.
Regarding claim 10, Nishtala discloses that the barrier layer is made of PVDC (¶ [0031] Suitable materials from which the interior layer may be selected include … polyvinylidene chloride (PVDC and its copolymers)).
Regarding claim 18, Nishtala and Bekele lack PVC or PUR layers. Quacquarella discloses a multilayer film material comprising PVC or PUR (col. 3, lines 1-5, Alternative adhesives that may suitably be employed include e.g. PVC plastisol adhesives and chlorinated modified polyolefin adhesives, col. 3, lines 20-30, at least one additional outer sealing layer … polyurethanes or blends thereof are employed for the sealing layer) and further discloses ranges for the thickness of these layers (col. 3, lines 50-60, (21) The thickness of the barrier layer as well as that of the other layers … In general the thickness of the barrier layer may range from about 4 to about 10 microns … The overall thickness of the substrate will generally range from about 40 to about 200 microns, typically from about 50 to about 130 microns, and preferably from about 60 to about 100 microns).
A skilled artisan would have been able to modify Nishtala and Bekele with Quacquarella’s PVC or PUR layers and dimensions by applying PVC and PUR around a central EVOH or PVDC layer. Regarding the rationale and motivation to modify Nishtala and Bekele with Quacquarella’s polymers and selection of layers, see the discussion of claims 7-9 and 11 above.
Claims 20-22, 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Nishtala and Bekele in view of Hatanaka; Makoto (US 20190010296 A1).
Regarding claims 20-22, 37 and 38, Nishtala and Bekele lack a PA, PUR or PE-based layer. Hatanaka discloses a polymer composition and film articles including bags or tubes (¶ [0003], [0015], [0079], hollow containers such as bags, cups, trays, tubes, bottles, and tanks);
comprising a multilayer film material (¶ [0084] Such a multilayered structure may include two or more layers of the EVOH resin composition and two or more layers of other thermoplastic resin);
which includes at least one barrier layer made of EVOH and/or PVDC (¶ [0088] The multilayered structure is not particularly limited in the configuration thereof so long as the multilayered structure includes at least one layer of the EVOH resin composition according to the invention); and
at least one carrier layer made of a robust, mechanically loadable material (¶ [0082] Examples of the thermoplastic resin … constituting the layers of a thermoplastic resin other than EVOH resins include polyolefin resins in a broad sense, such as: olefin homopolymers or copolymers including polyethylene resins … and polyalcohols obtained by reducing these polymers; ¶ [0089], In cases when a layer of the EVOH resin composition of the invention is expressed by a (a1, a2, . . . ) and a layer of other thermoplastic resin is expressed by b (b1, b2, . . . ), then the number of layers is usually 3-20, preferably 3-15, especially preferably 3-10. Specifically, any desired combinations are possible, such as b/a/b, a/b/a, a1/a2/b, a/b1/b2, b2/b1/a/b1/b2, and b2/b1/a/b1/a/b1/b2;);
wherein at least one barrier layer, in particular a barrier layer made of EVOH, is joined to a neighboring layer made of PA, in particular without a connecting, adhesion-assisting tie layer (¶ [0082], Examples of the other thermoplastic resin further include polyester resins, polyamide resins (including copolyamides), poly(vinyl chloride));
wherein at least one carrier layer, in particular a carrier layer made of PUR, is joined to a neighboring layer made of PA, in particular without a connecting, adhesion-assisting tie layer (¶ [0082], Examples of the other thermoplastic resin further include polyester resins, polyamide resins (including copolyamides), poly(vinyl chloride), poly(vinylidene chloride), acrylic resins, polystyrene, vinyl ester resins, polyester elastomers, polyurethane elastomers, chlorinated polyethylene, chlorinated polypropylene, aromatic or aliphatic polyketones, and polyalcohols obtained by reducing these polymers);
wherein a layer made of PA is joined to a PE-based layer by use of an adhesion promoter as an intermediate layer (¶ [0082] Examples of the thermoplastic resin … include polyolefin resins in a broad sense, such as: olefin homopolymers or copolymers including polyethylene resins, e.g., linear low-density polyethylene, low-density polyethylene, ultralow-density polyethylene, medium-density polyethylene, high-density polyethylene, and ethylene-α-olefin (α-olefin having 4-20 carbon atoms) copolymers, polypropylene resins such as polypropylene and propylene/α-olefin (α-olefin having 4-20 carbon atoms) copolymers).
wherein a gas- and/or water vapor-tight barrier layer is situated between an elastically deformable carrier layer made of PUR and a nonelastically deformable carrier layer made of PVC, for example (¶ [0082], Examples of the other thermoplastic resin further include … poly(vinyl chloride), poly(vinylidene chloride), acrylic resins, polystyrene, vinyl ester resins, polyester elastomers, polyurethane elastomers, chlorinated polyethylene, chlorinated polypropylene, aromatic or aliphatic polyketones, and polyalcohols obtained by reducing these polymers).
Hatanaka further discloses relative thicknesses for the barrier layer and carrier layers (¶ [0093] The thickness of the layer of the EVOH resin composition of the invention is usually 1-500 μm, preferably 3-300 μm, more preferably 5-200 μm; ¶ [0094] The thickness of the layer of other thermoplastic resin is usually 10-6,000 μm, preferably 20-4,000 μm, especially preferably 100-2,000 μm).
Hatanaka selects well-known polymers as carrier layers for a multi-layer laminate. A skilled artisan would have been able to modify Nishtala and Bekele with Hatanaka’s PA, PUR, PE or PVC layer by adding one or more layers of carrier material and adjusting their relative thicknesses. One would be motivated to modify Nishtala and Bekele with Hatanaka’s PA, PUR, PE or PVC layer to construct the film from available polymers. Hatanaka also acknowledges that the combination of layers improves the laminate’s mechanical strength and gas barrier property (¶ [0081]). Therefore, it would have been obvious to modify Nishtala and Bekele with Hatanaka’s PA, PUR or PE-based layer because these polymers will strengthen the laminate and are easily obtained.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Nishtala and Bekele in view of Bracken, Ronald L. et al. (US 20030139730 A1).
Regarding claim 23, Nishtala and Bekele 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 Bekele 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 Bekele with Bracken’s solvent bonding in order to assemble Nishtala’s components with a known technique.
Claims 26-30 and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Nishtala and Bekele in view of Göbel; Fred (US 20140358126 A1).
Regarding claims 26 and 28, Nishtala and Bekele 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, preferably 1.5 to 2.5 mm deep, at the apex (¶ [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 Bekele 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 Bekele with Göbel’s spiral-shaped indentation in order to hold the tube open against compressive forces.
Regarding claim 27, Nishtala, Bekele 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 Bekele lack separate intracorporeal and transosteal balloon segments. Göbel discloses a catheter system wherein that the catheter balloon has a radially expanded, intracorporeal balloon segment and a transosteal balloon segment that is radially tapered with respect to same (¶ [0145], The envelo