DETAILED OFFICIAL 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 .
Examiner Note
It is noted that all references hereinafter to Applicant’s specification (“spec”) are to the published application US 2023/0405294, unless stated otherwise. Further, any italicized text utilized hereinafter is to be interpreted as emphasis placed thereupon.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14 and 17-19 in the reply filed on 23 February 2026 is acknowledged. Claims 15-16 and 20-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) filed 25 July 2023, 13 October 2023, 06 June 2024, and 22 October 2025 are in compliance with 37 CFR 1.97 and have been considered.
Claim Objections
Claims 4, 8-9, 12, and 17-18 are objected to because of the following informalities.
[claim 4] The preamble recites the reference character (10), i.e. “The tube (10) of claim 1”, of which is inconsistent relative to each preamble of dependent claims 2-3 and 5-14 which recite “The tube of claim…”
In light of MPEP 608.01(m), to overcome the objection, it is respectfully suggested to amend claim 4 to remove the reference character (10) or to amend the other dependent claims identified above to include reference character (10)
[claim 8] improper and/or awkward grammar which detracts from the readability of the claim, identified below in marked-up format which also constitutes an amendment respectfully suggested to overcome the objection
“…or a mixture of the homopolymer and copolymer, and the outer layer (1) comprises”
[claim 9] lack of proper punctuation – see rejection of claim 9 under 35 U.S.C. 112(b) below for identification of, and corrective amendments for, the issue(s)
[claim 12] similar issue to that identified above in the objection to claim 8
“…having a radially inner wall surface that contacts the aqueous fluid, the outer (1) and inner (3) layers”
[claim 17] the word copolymer is spelled incorrectly and/or constitutes a typographical error
“the outer layer (1) comprises a cyclic olefin copolymer
[claim 18] same issue as that identified above in the objection to claim 4
Respectfully suggested to delete reference character (10) from the preamble of claim 18, or to amend the preamble of claim 19 to include said reference character; also respectfully suggested to correct the objections to claims 4 and 18 in the same manner, to improve claim language consistency and readability
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 6, 9-14, and 19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 6, there is insufficient antecedent basis for the phrase “the ethylene methyl acrylate copolymer”, which renders the claim indefinite. Claim 6 is directly dependent upon claim 4 and ultimately dependent upon claim 1, where neither claim 4 nor claim 1 recite an ethylene methyl acrylate copolymer – specifically, claims 1 and 4 each recite “ethylene acrylate copolymers”. As such, it is unclear if claim 6 is intended to further limit the species “ethylene acrylate copolymers” recited in claim 4 to the recited methyl acrylate copolymer, or if claim 4 was intended to introduce/recite “ethylene methyl acrylate copolymer”.
For examination on the merits, claim 6 is interpreted in accordance with the following amendment respectfully suggested for correction of the antecedent basis issue: “…wherein the middle layer (2) comprises more than 90% by weight of
Regarding claim 9, there is insufficient antecedent basis for the phrases “the polyurethane outer layer” and “the inner polypropylene layer” (of which also do not recite the reference characters designating the inner layer (3) and outer layer (1) recited in a substantially consistent manner amongst the other claims), of which renders the claim indefinite. It is unclear if the aforesaid phrases are (i) referring to the outer layer (1) comprising a thermoplastic polyurethane and the inner layer (3) comprising a polypropylene, respectively of claim 1, but in a shorthand/abbreviated form; or (ii) if the aforesaid phrases intend to the limit the outer (1) and inner (3) layers of claim 1, in some manner, to the polymer species recited, such as, e.g. excluding polymers other than polyurethane from the outer layer.
For examination on the merits, claim 9 is interpreted in accordance with the following amendment, of which is respectfully suggested in order to overcome the indefiniteness issues:
[claim 9] The tube of claim 1 wherein the thickness of the (1) is between 0.0254 and 0.635 mm (0.001 and 0.025 inches), the thickness of the inner (3) is between 0.0254 and 0.635 mm (0.001 and 0.025 inches) and the thickness of the middle layer (2) is between 0.0254 and 0.635 mm (0.001 and 0.025 inches).
Regarding claims 10-14, the phrase regarding the tube, and regarding the inner (3) and outer (1) layers, of “does [do] not visually delaminate” is ambiguous, including when read in view of the specification and thereby renders the claim indefinite. It is unclear if “visually delaminate” is (i) to be interpreted as visible to the naked human eye (plain meaning of the term “visually”), of which is capable of detecting/resolving physical features or details to an approximate limit of a fraction of a millimeter (about 0.01 mm, e.g. a human hair diameter is generally 0.05 mm), of (ii) if “visually delaminate” encompasses microscopic analysis of the tube/layers at magnification levels which are orders of magnitude higher than the approximate limit of the naked human eye. The former would be limited to separation of the layers which is visible to a person holding the delaminated tube in their hand in the absence of magnification equipment, whereas the scope of the latter includes delamination which is not visible to a person in the aforesaid scenario but is visible through artificial magnification, e.g. 200x, 500x, 1000x under a microscope. The distinct interpretations resulting in the ambiguity directly correlate to the scope of the physical/chemical degradation of the materials/bonds effecting delamination, and thereby the scope of the degradation of the mechanical/physical properties of the tube as a whole.
As such, one of ordinary skill in the art would not be able to envisage or readily determine the metes and bounds of the scope of the claim, and the public would not be readily apprised of what constitutes infringement thereupon. See MPEP 2111, MPEP 2111.01(I) and (II), MPEP 2173, MPEP 2173.01(I), MPEP 2173.02, and MPEP 2173.05(a)(I).
For examination on the merits, the phrase recited in claims 10-14 is interpreted as delamination which is visible down to a magnification level (max.) of 200x – see spec [Figs. 6-7; 0063-0065, 0101-0103]. In order to overcome the indefiniteness issue, it is respectfully suggested to amend the claims to clarify the maximum magnification level associated with “visually delaminate”.
Claim 19 recites the phrase “visually delaminate” and is therefore indefinite and rejected on the same grounds set forth above in the rejection of claims 10-14.
Appropriate action is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robben et al. (US 5,803,130; “Robben”).
Regarding claim 1, Robben discloses a multilayer, coextruded plastic tube intended for conveying liquids for medical use through the lumen thereof and into the human body, e.g. for therapy or analysis (A tube adapted for in vivo transport of an aqueous fluid to a subject), wherein said tube requires sufficient resistance to delamination, particularly after heat sterilization [Abstract; col. 1 ln. 4-5, 13-16; col. 2 ln. 1-12; col. 3 ln. 44-47; col. 4 ln. 21-43, 64-66]. The coextruded tube includes at least an inner layer, outer layer, and an intermediate layer interposed therebetween and bonded thereto [col. 2 ln. 25-33; col. 4 ln. 64-66] (comprising an inner layer (3), middle layer (2), and outer layer (1), wherein the tube is formed by a co-extrusion process, the inner, middle, and outer layers are concentric and the inner layer and outer layer are adhered to the middle layer and thus adhered to each other).
The inner layer comprises, or may consist essentially of a polymeric material that is, inter alia polypropylene [col. 3 ln. 44-47; col. 4 ln. 21-30] (the inner layer (3) comprises a polypropylene); the outer layer comprises, or may consist essentially of a polymeric material that is, inter alia polyurethane [col. 4 ln. 30-34] (the outer layer (1) comprises a thermoplastic polyurethane); and the intermediate layer comprises, or may consist essentially of a polymeric material selected from ethylene-ethyl acrylate (EEA) copolymers, ethylene-methyl acrylate (EMA) copolymers, modified ethylene-ethyl acrylate copolymers, and terpolymers of ethylene, maleic anhydride, and an acrylate [col. 1 ln. 30-56] (the middle layer (2) is selected from one or more of…ethylene acrylate copolymers, ethylene-acrylate maleic anhydride terpolymers). See MPEP 2131.02(II).
Given that the tube is coextruded, the polyurethane of the outer layer must necessarily be melt-moldable (i.e. capable of melt extrusion) and thereby, a thermoplastic polyurethane as indicated above.
The multilayer coextruded tube of Robben, set forth/cited above, anticipates the tube defined by each and every limitation of claim 1.
Regarding claim 2, the rejection of claim 1 above reads on the tube defined by claim 2. The intermediate layer (middle layer (2)) of the tube of Robben is, inter alia an ethylene-ethyl acrylate copolymer or ethylene-methyl acrylate copolymer (middle layer (2) comprises an ethylene ethyl acrylate copolymer).
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Robben as applied to claim 1 under 35 U.S.C. 102(a)(1) above.
Regarding claim 9, in view of the rejection of claim 1 under 102(a)(1) and the coextruded multilayer tube of Robben set forth/cited above, Robben does not explicitly disclose each of the outer layer comprising/consisting essentially of polyurethane, the intermediate layer, and the inner layer comprising/consisting essentially of polypropylene exhibiting a thickness of 0.0254 to 0.635 mm as claimed.
However, Robben reasonably teaches one of ordinary skill in the art that the multilayer tube (“second method”) intended for conveyance of liquids for medical use [col. 3 ln. 44-47; col. 4 ln. 21-43] may exhibit the following layer thicknesses [Table 2, Ex. 8-9] – inner layer: 0.27 mm, intermediate layer: 0.45 mm, outer layer: 0.28 mm, the total thickness being 1 mm [Ex. 9]; or alternatively inner layer: 0.40 mm, intermediate layer: 0.28 mm, outer layer: 0.35 mm, total thickness of 1.03 mm [Ex. 8]. Thus, Robben also reasonably teaches that the multilayer tube may have a total thickness (wall thickness) of about 1 mm.
Further, Robben teaches that the relative thickness of the intermediate layer may range from, advantageously 1-50% of the tube thickness, such as 15-50%, or preferably 15-30% [col. 3 ln. 8-21; Table 2, Ex. 8; claim 1], wherein the remainder (e.g. 50-99%, 50-85%, preferably 70-85%) of the total tube thickness is constituted by the inner and outer layer thicknesses which may be about the same, or one greater than the other [Table 2, Ex. 8-9] – e.g. the Ex. 8 relative thicknesses (outer:inter:inner) are 34:27:39.
In view of thereof, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have formed the multilayer tube of Robben set forth/cited above in the rejection of claim 1 to a total tube wall thickness of about 1 mm, and in accordance with the exact layer thicknesses of Ex. 8, or at the very least in accordance with the preferred intermediate layer relative thickness of 15-30% and approximately equivalent inner and outer layer thicknesses, with the reasonable expectation of successfully achieving the predictable result of a multilayer tube suitable for the aforesaid intended use in the medical field and exhibiting resistance to delamination after heat sterilization.
Accordingly, the intermediate layer of the multilayer coextruded tube of Robben would have exhibited a thickness of about 0.15 to 0.30 mm, such as 0.28 mm, and each of the inner and outer layers would have exhibited a thickness of about 0.35 to about 0.425 mm, such as 0.35 mm (outer) and 0.40 mm (inner), e.g. 0.35 mm/0.28 mm/0.40 mm (outer/inter/inner), wherein each of the aforesaid thicknesses or thickness ranges are with the corresponding claimed ranges, respectively. See MPEP 2131.03, MPEP 2144.05(I). the multilayer coextruded tube of Robben, as modified above, reads on the tube defined by claim 9.
Claims 4-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Robben as applied to claim 1 under 35 U.S.C. 102(a)(1) above, in view of Bourgeois et al. (US 2013/0190714; “Bourgeois”).
Regarding claim 4, as set forth above in the rejection of claim 1 under 102(a)(1), the inner layer, intermediate layer, and outer layer of the tube of Robben may each consist essentially of the respective polymeric materials, that is, polypropylene (homopolymer), ethylene-ethyl acrylate or ethylene-methyl acrylate copolymer (inter alia), and (thermoplastic) polyurethane respectively. Given that Robben does not specify or imply any other requisite materials/additives included in forming the respective layers, and, e.g. explicitly recognizes usual additives included in the intermediate layer as “optional” [col. 2 ln. 38-44], the phrase consist[ing] essentially of is reasonably interpreted as encompassing embodiments of the tube where the respective layers may be formed solely from the aforesaid polymeric materials, e.g. up to 100 wt.% of the respective polymeric material.
Thus, the teachings of Robben reasonably encompass embodiments of the tube wherein the inner layer is formed from up to 100 wt.% polypropylene homopolymer, the intermediate layer is formed from up to 100 wt.% ethylene-ethyl acrylate or ethylene-methyl acrylate copolymer, and the outer layer is formed from up to 100 wt.% thermoplastic polyurethane, wherein each of the aforesaid ranges render prima facie obvious each claimed range of “more than 90% by weight” (see MPEP 2144.05(I)).
With respect to the difference(s) relative to the tube defined by claim 4, Robben is silent regarding the polyurethane forming the outer layer of the tube being an aromatic or aliphatic polyether-based polyurethane.
Bourgeois is directed to coextruded multilayer medical tubing suitable for use in transporting fluids for in vivo treatment of human patients [Abstract; Figs. 1-2; 0001-0002, 0035], said tubing including concentric inner, intermediate, and outer polymeric layers [0004]. The intermediate layer comprises an ethylene-ethyl acrylate or ethylene-methyl acrylate copolymer which functions to bind (chemically adhere) the inner and outer layers [0004, 0006, 0008].
Bourgeois teaches that the outer layer is formed from a polyurethane thermoplastic elastomer (TPU), specifically, greater than 90 wt.% of an aromatic or aliphatic polyether-based polyurethane, wherein the aromatic polyether-based polyurethane typically is a polytetramethylene glycol-based polyurethane [0006, 0010-0012, 0020, 0051]; the TPU imparts structural stability to the tubing [0004, 0036], and is readily adhered to/adherable by the aforesaid acrylate copolymers [0004, 0038, 0052]. Bourgeois teaches that Lubrizol TPU Pellethane® 2363-90 AE is a suitable polytetramethylene glycol-based polyurethane [0051], as are those/others of the 2363-80 AE series [0056] – the aforesaid TPUs are visually clear/transparent, and resist delamination and loss of transparency after being subject to sterilization processes [0058]. See MPEP 2144.07.
Robben and Bourgeois constitute prior art which is directly analogous to the claimed invention. In view of the combined teachings of the foregoing prior art, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have modified the tube of Robben (set forth/cited above) by having utilized an aromatic polytetramethylene glycol-based TPU, and/or specifically Pellethane® 2363-90AE (or a TPU from the 2363-80 AE Pellethane® series from Lubrizol) as the thermoplastic polyurethane of the outer layer of the tube, in order to increase the resistance to delamination and transparency loss after sterilization of the tube, and/or because the aforesaid TPU would have been readily recognized as a suitable polyurethane for use in medical tubes intended for transporting fluids for in vivo treatment and capable of strong bonding to the intermediate ethylene acrylate copolymer layer (MPEP 2144.07).
In accordance with the foregoing modification, the outer layer of the coextruded tube of Robben (hereinafter “modified Robben”) would have been formed from up to 100 wt.% (consisted essentially of) of an aromatic polytetramethylene glycol-based TPU, and/or formed from up to 100 wt.% of Pellethane® 2363-90 AE; or alternatively up to 100 wt.% of a TPU from the 2363-80 AE Pellethane® series from Lubrizol.
The coextruded tube of modified Robben above reads on the tube defined by each and every limitation of claim 4.
Regarding claim 5, in view of the rejection of claim 4 above, modified Robben is silent regarding the ethylene-ethyl acrylate copolymer (defining up to 100 wt.% of intermediate layer, which bonds the TPU of outer layer to polypropylene of inner layer) having at least 19.5 wt.% ethyl acrylate content (claim 5).
The disclosure/teachings of Bourgeois set forth/cited above at ¶38-39 are incorporated herein by reference (not repeated). Further, Bourgeois teaches that the ethylene-ethyl acrylate copolymer which adheres the TPU outer layer to the polyolefin-based inner layer of the tube typically comprises at least about 19.5 wt.% ethyl acrylate content [0004, 0011, 0038], wherein the ethyl acrylate content controls the elasticity and softness of the EEA copolymer, and delamination between, inter alia the outer TPU layer and EEA copolymer (intermediate layer) does not occur after the tube is strained or stretched in a tensile manner or submersed in water [0004, 0008, 0011, 0051]. Bourgeois teaches that Dow Amplify® EA 103 is a suitable EEA copolymer which has about 19.5 wt.% EA content [0051]. See MPEP 2144.07.
In view of the combined teachings of the foregoing prior art, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the tube of Robben (set forth above in rejection of claim 4) by having utilized an EEA copolymer having an EA content of 19.5 wt.%, and/or specifically Dow Amplify® EA 103, as the EEA copolymer of the intermediate layer of the tube, as the aforesaid EEA copolymer would have been readily recognized as a suitable EEA copolymer for adhering the TPU of the outer layer to the polypropylene (polyolefin) of the inner layer of the medical tube intended for transport of fluids for in vivo treatment, and/or recognized for their excellent visual clarity as desired by Robben, and/or to achieve the predictable result of increased resistance to delamination due to strong chemical adhesion between the layers and interlayer monolithic nature of the tube attributed to the EA content. See MPEP 2144.07.
In accordance with the foregoing modification, the intermediate layer of the coextruded tube of modified Robben would have been formed from up to 100 wt.% of an EEA copolymer having 19.5 wt.% EA content, and/or been formed from up to 100 wt.% of the EEA copolymer Dow Amplify® EA 103. The aforesaid tube of modified Robben reads on the tube defined by claim 5 as dependent upon claim 4.
Regarding claim 5, in view of (and as set forth in) the rejection of claim 4 above, the intermediate layer of the tube of modified Robben is suitably formed from up to 100 wt.% of ethylene-methyl acrylate copolymer (comprises more than 90% by weight of an ethylene methyl acrylate copolymer). As such, the tube of modified Robben set forth above reads on the tube defined by claim 6.
Regarding claim 8, in view of the rejection of claim 1 under 102(a)(1) above, the rejection of claim 4 above is incorporated herein by reference (not repeated) and reads on the tube defined by claim 8. That is, the tube of modified Robben – inner layer formed from up to 100 wt.% polypropylene homopolymer (inner layer (3) comprises more than 90% by weight of a polypropylene homopolymer or a polypropylene copolymer or a mixture of the homopolymer and copolymer), intermediate layer formed from up to 100 wt.% EEA or EMA copolymer, and outer layer formed from up to 100 wt.% aromatic polytetramethylene glycol-based TPU, such as Pellethane® 2363-90 AE (the outer layer (1) comprises more than 90% by weight of a polytetramethyleneglycol-based polyurethane) – reads on the tube defined by claim 8.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Robben as applied to claim 1 under 35 U.S.C. 102(a)(1) above, in view of Mueller (US 4,948,643; “Mueller”).
Claims 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Robben as applied to claim 1 under 35 U.S.C. 102(a)(1) above, in view of Mueller and Bourgeois.
Regarding claim 3, in view of the rejection of claim 1 under 102(a)(1) above, the intermediate layer of the coextruded tube of Robben may comprise or consist essentially of ethylene-ethyl acrylate (EEA) or ethylene-methyl acrylate (EMA) copolymer, wherein said intermediate layer bonds (chemically bonds/adheres) the TPU forming the outer layer to the polypropylene forming the inner layer.
Robben is silent regarding the intermediate layer comprising ethylene-vinyl acetate (EVA) copolymer (claim 3, wherein the middle layer (2) comprises ethylene vinyl acetate).
Mueller – directed to coextruded tri-layer medical tubing for transport of fluids for in vivo treatments [Abstract; Fig. 1; col. 1 ln. 6-36; col. 4 ln. 10-11] – teaches that EVA copolymer, such as du Pont Alathon® 3175 having about 28 wt.% vinyl acetate content: is suitable for use as an intermediate adhesive layer in tri-layer medical tubes; is suitable for/capable of bonding polyurethane, copolyester, EVA/copolyester blends, polypropylene homopolymers, polypropylene copolymers, polyvinyl chloride (PVC) and propylene-ethylene copolymers; is a suitable (intermediate adhesive layer material) and functionally-equivalent alternative to EMA copolymer; and can be blended with EMA copolymer for the aforesaid use [col. 3 ln. 10–col. 4 ln. 8; claim 1]. See MPEP 2144.06(I) and (II), MPEP 2144.07.
Robben and Mueller each constitute prior art which is directly analogous to the claimed invention. In view of the combined teachings of the foregoing prior art, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the intermediate layer of the tube of Robben (set forth above in rejection of claim 1) by having utilized EVA copolymer having about 28 wt.% vinyl acetate content, such as Alathon® 3175 in place of the EMA copolymer, or by having blended said EVA copolymer with said EMA copolymer (utilizing EVA and EMA in combination), as the EVA copolymer would have been readily recognized as suitable for use as the adhesive intermediate layer polymeric material and capable of bonding via coextrusion the polyurethane of the outer layer to the polypropylene of the inner layer, and/or readily recognized as functionally equivalent to EMA copolymer for the aforesaid use, and/or expressly taught as suitable for blending with EMA. Applicant is respectfully directed to MPEP 2144.06(I) – it is prima facie obvious to combine two components, each taught by the prior art to be useful for the same purpose, to form a composition to be used for the very same purpose, wherein the idea of combining them flows logically from their having been individually taught in the prior art. Further, see MPEP 2144.06(II) – an express suggestion to substitute one equivalent component for another is not necessary to render such substitution obvious.
In accordance with the foregoing modification(s), the intermediate layer of the coextruded tube of Robben would have been formed from EVA copolymer (28 wt.% vinyl acetate), or alternatively would have been formed from a blend of EMA copolymer and EVA copolymer (28 wt.% vinyl acetate). The tube of modified Robben set forth above reads on the tube defined by claim 3 (middle layer (2) comprises ethylene vinyl acetate).
Regarding claims 4 and 7, the rejection of claim 3 above (¶51-55) and the rejection of claim 4 (¶35-42) above are incorporated herein by reference (not repeated) and, taken in combined totality, read on the tube defined by claim 4 and the tube defined by claim 7 as dependent upon claim 4. In short, it would have been obvious to have modified the coextruded tube of Robben in accordance with the foregoing grounds of rejection, thereby resulting in the intermediate layer consisting essentially (i.e. formed from up to 100 wt.%) of EMA, EVA, or a combination of EVA and EMA, the EVA having 28 wt.% vinyl acetate content, the outer layer consisting essentially of an aromatic polytetramethylene glycol-based TPU, such as (specifically) Pellethane® 2363-90AE, with the (non-modified) inner layer consisting essentially of polypropylene homopolymer.
The tube of modified Robben set forth above reads on the tube defined by claim 4, and the tube defined by claim 7 as dependent upon claim 4. The EVA vinyl acetate content of 28 wt.% is within the claimed range of at least 19.5 percent vinyl acetate content by weight (claim 7).
Claims 1-2, 4-6, and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bourgeois, in view of Marggi et al. (US 2020/0406019; “Marggi”) and Sevinc et al. (US 2022/0143273; “Sevinc”), optionally further in view of Mueller.
The Borealis Product Data Sheet for Bormed™ SC820CF-11 (19 May 2014) (hereinafter “Bormed™ SC820CF-11 PDS”; copy provided herewith) is relied upon as an evidentiary reference in support of the grounds of rejection.
Regarding claim 1, Bourgeois discloses a coextruded multilayer tube suitable for transport of fluids for in vivo treatment of human patients, said tube comprising an inner layer (3), outer layer (1), and an intermediate layer (2) interposed therebetween [Abstract; Figs. 1-2; 0001-0002, 0004, 0039, 0043-0045]. The outer layer comprises at least 90 wt.% of a thermoplastic polyurethane, in particular an aromatic polytetramethylene glycol-based polyurethane (aromatic polyether-based TPU) – the TPU may be from the Lubrizol Pellethane® 2363-80 AE series, e.g. Pellethane® 2363-90 AE [0004, 0006, 0010-0012, 0020, 0051, 0056].
The intermediate layer – disposed between and adhering the inner and outer layer – comprises at least 90 wt.% of acrylate polymer, specifically one or more of ethylene-ethyl acrylate (EEA) copolymer (19.5 wt.% EA content, e.g. Dow Amplify® EA 103), ethylene-methyl acrylate (EMA) copolymer (20 wt.% or 24 wt.% MA content, e.g. Westlake MA SP2220 or Westlake MA SP2268), and anhydride grafted ethylene-methyl acrylate (AEMA) copolymer (e.g. Westlake Tymax GA 7001) [0004, 0006, 0008, 0011, 0051].
The inner layer (fluid contact layer, defining the inner lumen of the tube) comprises at least 90 wt.% of a polyethylene, typically low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), high-density polyethylene (HDPE), or blends thereof [0004, 0006, 0010-0012, 0019, 0051, 0055].
Bourgeois discloses that the tube exhibits visual clarity (transparency), and may return to near original dimensions and does not visually delaminate after being strained or stretched in a tensile manner along the longitudinal axis at a stress up to about 55 MPa and a strain up to about 900-950% and after being submerged in water at 60° C for about 36 hours [0008, 0015-0022, 0052, 0058].
With respect to the difference(s) relative to the tube defined by claim 1, Bourgeois is silent regarding the inner layer comprising polypropylene.
Marggi is directed to multilayer coextruded medical tubes for administration of fluids to a patient, said tube comprising or consisting of an inner layer and an outer layer, of which are preferably bonded to one another in the absence of an adhesive layer therebetween, e.g. physically via shrink-fitting or form/force fitting, but not limited thereto such that the inner and outer layer may be chemically bonded to one another [Abstract; Figs. 1-2; 0002-0004, 0014-0016, 0019, 0030-0031] (see MPEP 2123(I) and (II)). The outer layer is formed from a thermoplastic polyether-based polyurethane [0015, 0017, 0030].
Marggi teaches that the inner layer is suitably formed from HDPE and/or polypropylene – each can be compatible with the fluid intended for transporting/administration to a patient (inner layer chemically/physically inert relative to fluid) [0018, 0030]. A suitable HDPE for the intended use is Sabic® HDPE B5429, and a suitable polypropylene is Borealis Bormed™ SC820CF-11 [0018-0020, 0030], wherein the inner layer may consist of said HDPE or polypropylene [0030]. As such, Marggi reasonably teaches one of ordinary skill in the art that polypropylene, e.g. Bormed™ SC820CF-11 is suitable for forming the inner layer of the medical tube, and is a functionally equivalent alternative to HDPE for the same (see MPEP 2144.07, MPEP 2144.06(II)).
Sevinc is directed to multilayer coextruded medical tubes for administration of fluids to a patient, said tubes exhibiting low absorption of the fluids transported therein/administered thereby [Abstract; Fig. 2; 0002-0003, 0005, 0007, 0019, 0046]; the tubes include an outer layer, intermediate tie layer, and an inner layer, wherein the outer layer is formed from a polyether-based TPU such as Pellethane® [Fig. 2; 0020-0023, 0026, 0032-0037; Tables 1-2].
Sevinc teaches that in the alternative to HDPE or LDPE, the inner layer is suitably formed from polypropylene [0020-0021, 0032-0034, 0039; Table 2], e.g. an extrudable, sterilization grade random polypropylene copolymer [0032-0033, 0039-0040; Tables 2-3]. As such, Sevinc reasonably teaches that it was well recognized in the art that polypropylene is suitable for forming the inner layer of the medical tube and capable of being subject to sterilization treatments associated therewith, and is a functionally equivalent alternative to LDPE and HDPE for the same (see MPEP 2144.07, MPEP 2144.06(II)).
Mueller (see ¶53 above, which is incorporated herein by reference) teaches that, inter alia polypropylene is suitable for use in forming the inner layer (fluid contacting layer) of multilayer coextruded medical tubes for transporting/administering medical solutions to a patient, wherein polypropylene exhibits the requisite degree of heat resistance required for autoclaving (sterilization treatment) of the tube [col. 4 ln. 1-6] and is capable of chemically bonding/adhering to other materials through acrylate adhesives [col. 3 ln. 30-57].
Bourgeois, Marggi, Sevinc, and Mueller each constitute prior art which is directly analogous to the claimed invention. In view of the combined teachings of Bourgeois, Marggi, and Sevinc, optionally also in view of Mueller, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the coextruded tube of Bourgeois by having formed the inner layer thereof from Bormed™ SC820CF-11 polypropylene in place of LDPE/LLDPE/HDPE, as SC820CF-11 (and polypropylene homopolymer or copolymers, in general) would have been readily recognized as a suitable, functionally equivalent alternative to the aforesaid polyethylenes for forming the inner layer of the tube intended for direct contact with the medical fluids transported therein (MPEP 2144.06(II)), and/or readily recognized as a suitable polymeric material for said intended use as taught by Marggi (MPEP 2144.07), further in light of its compatibility with acrylate adhesives (Mueller), capability to be sterilized, and low haze property (high clarity) [Bormed™ SC820CF-11 PDS, pp. 1-2].
In accordance with the foregoing modification, the inner layer of the coextruded multilayer tube of Bourgeois would have been formed from (i.e. consisted of), or comprised at least 90 wt.% of, Bormed™ SC820CF-11 polypropylene (random polypropylene copolymer) [Bormed™ SC820CF-11 PDS, p. 1] (rather than LDPE, LLDPE, or HDPE), with the outer and intermediate layers defined as set forth/cited above (¶60-61).
The coextruded multilayer tube of Bourgeois, as modified above (hereinafter “modified Bourgeois”), reads on the tube defined by each and every limitation of claim 1.
Regarding claim 2, the rejection of claim 1 above reads on the tube defined by claim 2 – the intermediate layer of the tube of modified Bourgeois comprises at least 90 wt.% of one or more of EEA copolymer, EMA copolymer, and AEMA copolymer (wherein the middle layer (2) comprises an ethylene ethyl acrylate copolymer or an ethylene methyl acrylate copolymer or an anhydride grafted ethylene methyl acrylate copolymer…or a mixture of two or more of the foregoing).
Regarding claim 4, the rejection of claim 1 above reads on the tube defined by claim 4 – Bormed™ SC820CF-11, which defines at least 90 wt.% of the inner layer, is a polypropylene copolymer, and the TPU of the outer layer is an aromatic polytetramethylene glycol-based (polyether-based) polyurethane.
Regarding claim 5, the rejections of claims 1 and 4 above read on the tube defined by claim 5 – the EA content of the EEA copolymer is 19.5 wt.%.
Regarding claim 6, the rejections of claims 1 and 4 above read on the tube defined by claim 6 – the intermediate layer may comprise at least 90 wt.% of EMA copolymer.
Regarding claim 8, the rejection of claim 1 above reads on the tube defined by claim 8 – Bormed™ SC820CF-11, which defines at least 90 wt.% of the inner layer, is a polypropylene copolymer, and the TPU of the outer layer is an aromatic polytetramethylene glycol-based (polyether-based) polyurethane.
Regarding claim 9, in view of the rejection of claim 1 above, Bourgeois discloses that each of the inner layer, intermediate layer, and outer layer exhibit a thickness (wall thickness) of about 0.001 to about 0.025 in (about 0.0254 to 0.635 mm) [0007, 0014, 0057], of which is identical to each claimed range, respectively.
Regarding claims 10-14, as set forth above in the rejection of claim 1, Bourgeois discloses that the coextruded multilayer tube does not visually delaminate after being subject to tensile stress (up to 55 MPa)/strain (up to 900-950%) in the longitudinal direction and after being submerged in water at 60° C for about 36 hours. Further, as is clear from the aforecited disclosure/figures of Bourgeois, the tube includes a central axis fluid flow passage (inner lumen) through which aqueous fluids are/are intended to be routed, wherein the inner layer has a radially-inner wall surface that contacts the aqueous fluid [Figs. 1-2; 0002, 0005, 0007, 0053].
Modified Bourgeois does not explicitly disclose [that] the coextruded multilayer tube (set forth above in the rejection of claim 1) (a) does not visually delaminate from the middle layer at a stress up to 20 MPa and a strain up to 400% (claim 10), (b) does not visually delaminate when submersed in water at 60° C for 72 hours (claims 11 and 14), and (c) that the outer and inner layers do not visually delaminate from the middle layer at a stress up to 20 MPa and strain up to 400% and the tube does not visually delaminate after being submerged in water at 60° C for 72 hours (claims 12 and 13).
However, the (I) coextruded multilayer tube of modified Bourgeois is substantially identical or identical to Applicant’s claimed and disclosed tube in terms of each of the following elements (i)-(vi):
(i) outer layer thickness, and outer layer comprising at least 90 wt.% aromatic polytetramethylene glycol-based thermoplastic polyurethane (TPU)
(ii) TPU species – TPU of modified Bourgeois is Pellethane® 2363-90AE; Applicant’s disclosed TPU is, inter alia Pellethane® 2363-90AE [spec, 0069, 0075]
(iii) intermediate layer thickness, and intermediate layer comprising at least 90 wt.% of an acrylate polymer that is one or more of EEA, EMA, and AEMA copolymers
(iv) acrylate polymer species, and EA or MA content – the EEA, EMA, and AEMA copolymers of modified Bourgeois, respectively, are Dow Amplify® EA 103 (EEA, 19.5 wt.% EA), Westlake MA SP2268 or SP2220 (EMAs, 24 wt.% or 20 wt.% MA), and Westlake Tymax® GA 7001 (AEMA), respectively; Applicant’s disclosed acrylate polymers are, inter alia Amplify® EA 103, Westlake MA SP2268 and SP2220, and Westlake Tymax® GA 7001 [spec, 0070]
(v) inner layer thickness, and inner layer comprising at least 90 wt.% of a polypropylene homopolymer or copolymer
(vi) the multilayer tube being formed by coextrusion of the concentric outer/intermediate/inner layers.
Further, the (II) polypropylene copolymer Bormed™ SC820CF-11 of the inner layer of the tube of modified Bourgeois exhibits a tensile strain at break of 650% in the machine direction (MD), i.e. longitudinal direction, and 670% in the transverse direction (TD), a tensile strength of 50 MPa in both MD and TD, a tensile modulus of 330 MPA in both MD and TD, and a flexural modulus of 550 MPa [Bormed™ SC820CF-11 PDS, pp. 1-2], of which exceed the claimed 400% max. strain and 20 MPa max. stress.
In view of reason (I), including (i)-(vi), and reason (II) set forth above, and given that Bourgeois explicitly discloses that the tube (pre-modification) does not visually delaminate after/at the conditions cited above (see ¶79) which are similar to the claimed conditions, it stands to reason – and there is a strong expectation – that the multilayer coextruded tube of modified Bourgeois necessarily would not have visually delaminated upon having been subject to the claimed conditions corresponding to (a), (b), and (c) above (see ¶80) ((a) corresponds to claim 10, (b) corresponds to claims 11 and 14, (c) corresponds to claims 12 and 13), absent a showing of factually supported objective evidence to the contrary. See MPEP 2112(IV) and (V); MPEP 2112.01(I) and (II); MPEP 2145; and MPEP 2145(I).
As such, the tube of modified Bourgeois above reads on each tube defined by claims 10-14.
Claims 3-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Bourgeois in view of Marggi and Sevinc (and optionally Mueller), evidenced by Bormed™ SC820CF-11 PDS, as applied to claim 1 above, further in view of Mueller.
Regarding claim 3, in view of the rejection of claim 1 under 35 U.S.C. 103 above and the coextruded multilayer tube of modified Bourgeois established thereby, Bourgeois is silent regarding the intermediate layer comprising ethylene vinyl acetate (EVA) copolymer.
The disclosure/teachings of Mueller set forth/cited above at ¶53 are incorporated herein by reference (not repeated for sake of brevity).
In view of the combined teachings of the foregoing prior art, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the coextruded multilayer tube of modified Bourgeois (set forth above in rejection of claim 1) by having blended EVA copolymer having about 28 wt.% vinyl acetate content (e.g. Alathon® 3175) with the EMA copolymer to define in combination at least 90 wt.% of the intermediate layer of the tube, as the EVA copolymer would have been readily recognized as functionally equivalent to EMA copolymer for use in the intermediate adhesive layer bonding the TPU to polypropylene copolymer, and explicitly taught/readily recognized as suitable for blending with said EMA copolymer for the aforesaid purpose/use (see MPEP 2144.06(II); see ¶54 above), and/or to increase the flexibility of the intermediate layer while retaining the adhesive nature thereof [Mueller, col. 3 ln. 30-47].
In accordance with the foregoing modification, at least 90 wt.% of the intermediate layer of the tube of modified Bourgeois would have been formed from a blend of EMA copolymer and EVA copolymer, the EVA copolymer having a vinyl acetate content of 28 wt.%. The resultant tube of modified Bourgeois reads on the tube defined by claim 3 (wherein the middle layer (2) comprises ethylene vinyl acetate).
Regarding claims 4 and 7, the rejection of claim 3 above is incorporated herein by reference and reads on the tube defined by claim 4, as well as the tube defined by claim 7 dependent upon claim 4.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Robben, in view of Wolkenstoerfer et al. (US 2018/0117295; “Wolkenstoerfer”).
Planeta et al. (US 2014/0203027; “Planeta”) is relied upon as an evidentiary reference in support of the grounds of rejection.
Regarding claim 17, Robben discloses a multilayer, coextruded plastic tube intended for conveying liquids for medical use through the lumen thereof and into the human body, e.g. for therapy or analysis (A tube adapted for in vivo transport of an aqueous fluid to a subject), wherein said tube requires sufficient resistance to delamination, particularly after heat sterilization [Abstract; col. 1 ln. 4-5, 13-16; col. 2 ln. 1-12; col. 3 ln. 44-47; col. 4 ln. 21-43, 64-66]. The coextruded tube includes at least an inner layer, outer layer, and an intermediate layer interposed therebetween and bonded thereto [col. 2 ln. 25-33; col. 4 ln. 64-66]
The inner layer comprises, or may consist essentially of a polymeric material that is, inter alia polypropylene [col. 3 ln. 44-47; col. 4 ln. 21-30] (the inner layer (3) comprises a polypropylene). The intermediate layer comprises, or may consist essentially of a polymeric material selected from EEA copolymers, EMA copolymers, modified EEA copolymers, and terpolymers of ethylene, maleic anhydride, and an acrylate [col. 1 ln. 30-56] (the middle layer (2) is selected from one or more of…ethylene acrylate copolymers, ethylene-acrylate maleic anhydride terpolymers). See MPEP 2131.02(II), MPEP 2144.07.
The outer layer comprises, or may consist essentially of a polymeric material that is, inter alia a copolyester or a mixture of copolyester and an EVA copolymer [col. 3 ln. 22-39; col. 4 ln. 30-34].
With respect to the difference(s) relative to the tube defined by claim 17, Robben is silent regarding the outer layer comprising a cyclic olefin copolymer (COC). Additionally, Robben does not explicitly disclose the tube being resistant to delamination (does not visually delaminate) at a stress of up to 20 MPa and a strain up to 400%, as well as after being submerged in water at 60° C for 72 hours (claim 19).
Wolkenstoerfer teaches that as an alternative to copolyesters, the outer layer of coextruded multilayer medical tubes (bonded to an inner layer via an intervening adhesive tie layer) is suitably formed from COC [Abstract; Fig. 3; 0002-0003, 0007-0008, 0014-0017, 0022, 0025, 0031, 0043, 0051]. Wolkenstoerfer teaches that COCs exhibit high, adjustable heat resistance within the range of 65-190° C, good thermoplastic (melt) flowability, high strength/hardness, high transparency, and good resistance to acid and alkali [0014, 0016-0017]. Use of the COC as the outer layer of the tube also imparts solvent bonding capability thereto, allowing the tube to be solvent-bonded to medical containers/connectors [0017] – a preferred COC suitable for the aforesaid use is TOPAS E-140 [0016, 0022, 0043-0044, 0056]. As evidenced by Planeta, COCs are readily adhered to/by (capable of bonding to) ethylene-acrylate copolymers such as ethylene-methyl acrylate (EMA) and ethylene-acrylic acid (EAA) copolymers, such as (not limited to) those having from about 2 to 24 wt.% acrylate content [Planeta, 0008, 0013-0015, 0028-0029].
Robben and Wolkenstoerfer each constitute prior art which is directly analogous to the claimed invention. In view of the combined teachings of the foregoing prior art, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the tube of Robben by having utilized a COC, such as/specifically TOPAS E-140, in place of copolyester to form the outer layer, as the aforesaid would have been readily recognized as a functionally equivalent alternative to copolyesters suitable for forming the outer layer of the medical tube (MPEP 2144.06(II), MPEP 2144.07), and/or to impart solvent-bondability to the tube, and/or to benefit from any one or more of the properties identified above as taught by Wolkenstoerfer.
In accordance with the foregoing modification, the outer layer of the coextruded multilayer tube of Robben would have been formed from TOPAS E-140 COC, thereby reading on “the outer layer (1) comprises a cyclic olefin copolymer”. The tube of Robben, as modified above (“modified Robben”), reads on the tube defined by each and every limitation of claim 17.
Regarding claim 18, it is noted that ¶35 above, related to the phrase “consisting essentially of” utilized by Robben, is incorporated herein by reference (not repeated). In view thereof, and in view of the rejection of claim 17 above, the coextruded multilayer tube of modified Robben reads on the tube defined by claim 18. That is, the inner layer comprises up to 100 wt.% polypropylene (e.g. homopolymer or copolymer), the intermediate layer comprises up to 100 wt.% EEA, EMA, and/or AEMA copolymer, and the outer layer comprises up to 100 wt.% TOPAS E-140 COC.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Robben in view of Wolkenstoerfer, evidenced by Planeta, as applied to claim 17 above, further in view of Marggi and Mueller.
The Bormed™ SC820CF-11 PDS and Pham et al. (US 2015/0018788; “Pham”) are relied upon as evidentiary references in support of the rejection of claim 19.
Regarding claim 19, in view of the rejection of claim 17 above, Robben, as modified, is silent regarding the inner and outer layers not visually delaminating from the intermediate layer at a stress up to 20 MPa and a strain up to 400%, and the tube not visually delaminating after being submerged in water at 60° C for 72 hours, as claimed.
Marggi (see ¶66 above) teaches that the Borealis AG polypropylene copolymer Bormed™ SC820CF-11 is suitable for the intended use as the inner(most), fluid-contacting layer of coextruded medical tubes which transport/administer fluids to a patient (physically/chemically inert relative to medical fluid) [0002-0005, 0015, 0018-0019, 0030] (MPEP 2144.07); SC820CF-11 is capable of being sterilized [Bormed™ SC820CF-11 PDS, p. 1].
Mueller teaches that EMA copolymers having MA content of 20 wt.% are suitable for use as the intermediate adhesive layer which adheres to the inner polypropylene-based layer of the coextruded medical tube [col. 3 ln. 30-47]. As evidenced by Planeta above (see ¶97), COCs are readily adhered by EMA copolymers, including those having 2-24 wt.% acrylate (i.e. MA) content.
Robben teaches the layer thicknesses/ratios set forth above at ¶31-33, of which are incorporated herein by reference. Further, the rejection of claim 18 above (¶100) is incorporated herein by reference.
In view of the combined teachings of the foregoing prior art, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the coextruded multilayer tube of modified Robben (set forth above in rejection of claim 17) by (a) having utilized Bormed™ SC820CF-11 as the polypropylene which forms up to 100 wt.% of the inner layer of the tube, as SC820CF-11 would have been readily recognized as suitable for the intended use as the inner fluid-contacting layer and exhibiting the capability of being subject to sterilization treatments required/recognized by Robben (MPEP 2144.07); by (b) having utilized an EMA copolymer with 20 wt.% MA content as the EMA copolymer of the intermediate layer to provide/tailor the necessary bond strength between the outer and inner layers (MPEP 2144.07); and by (c) having formed the outer, intermediate, and inner layers of the tube in accordance with the thicknesses/ratios disclosed by Robben, e.g. 0.35/0.28/0.40 mm (outer/inter/inner) (i.e. intermediate layer preferably defining 15-30%, or up to 50%, of the overall tube wall thickness).
In accordance with the foregoing modifications, the coextruded multilayer tube of modified Robben would have comprised the following:
outer layer – up to 100 wt.% E-140 COC; thickness of, e.g. 0.35 mm
intermediate layer – up to 100 wt.% EMA copolymer having MA content of 20 wt.%; thickness of, e.g. 0.28 mm
inner layer – up to 100 wt.% SC820CF-11 (random polypropylene copolymer); thickness of, e.g. 0.40 mm.
As evidenced by the Bormed™ SC820CF-11 PDS, SC820CF-11 exhibits a tensile strain at break of 650% in the machine direction (MD), i.e. longitudinal direction, and 670% in the transverse direction (TD), a tensile strength of 50 MPa in both MD and TD, a tensile modulus of 330 MPA in both MD and TD, and a flexural modulus of 550 MPa [Bormed™ SC820CF-11 PDS, pp. 1-2], of which exceed the claimed 400% max. strain and 20 MPa max. stress. As evidenced by Pham, TOPAS E-140 COC exhibits a tensile strain at break of greater than 450%, a tensile stress at break of greater than 19 MPa, a tensile modulus of 44 MPa, and an elongation at break of 640% (MD) and 620% (TD) [Pham, 0034; Table 1], of which exceed the claimed 400% max. strain and 20 MPa max. stress.
Given that the tube of modified Robben above is substantially identical or identical to the claimed and disclosed tube in terms of the layer thicknesses, EMA copolymer MA content (20 wt.%), and the outer, intermediate, and inner layers comprising greater than 90 wt.%, up to 100 wt.% of the aforesaid species of COC, EMA copolymer, and polypropylene copolymer respectively; and given that TOPAS E-140 and Bormed™ SC820CF-11 exhibit tensile stress at break and strain at break values which exceed the respective maximum values claimed, it stands to reason – and there is a strong expectation – that the coextruded multilayer tube of modified Robben necessarily would not have visually delaminated at a stress of up to 20 MPa and a strain up to 400%, as well as after submerged in water at 60° C for 72 hours, as claimed, absent a showing of factually supported objective evidence to the contrary. See MPEP 2112(IV) and (V); MPEP 2112.01(I) and (II); MPEP 2145; and MPEP 2145(I).
As such, the coextruded multilayer tube of modified Robben above reads on the tube defined by claim 19.
Pertinent Prior Art
The following constitutes a list of prior art which are not relied upon herein, but are considered pertinent to the claimed invention and/or written description thereof. The prior art are purposely made of record hereinafter to facilitate compact/expedient prosecution, and consideration thereof is respectfully suggested.
US 2012/0003410 to Tatarka – discloses medical tubing comprising layer(s) formed from COC, such as, inter alia TOPAS E-140 [Abstract; 0036-0057; Tables 1, 1A, 1B, 2]
US 5,631,325 to Latiolais et al. – discloses ethylene-alkyl acrylate copolymers having greater than 10 wt.% alkyl acrylate content [Abstract; col. 4 ln. 58–col. 5 ln. 15]
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Michael C. Romanowski whose telephone number is (571)270-1387. The Examiner can normally be reached M-F, 09:30-17:30.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Aaron Austin can be reached at (571) 272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL C. ROMANOWSKI/Primary Examiner, Art Unit 1782
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