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 2021/0113743, unless stated otherwise. Further, any italicized text utilized hereinafter is to be interpreted as emphasis placed thereupon.
Continued Examination Under 37 CFR 1.114
A request for continued examination (RCE) under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after the Final Rejection dated 25 August 2025 (hereinafter “FOA”). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the FOA has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 24 November 2025 has been entered.
Response to Amendment
The Amendment filed 24 November 2025 in response to the FOA and the Advisory Action (PTOL-303) dated 10 November 2025 has been entered. Claim 1 has been amended – as such, claims 1-5, 9-13, and 15-21 remain pending, claims 15-20 remain withdrawn as a result of previous restriction, and claims 1-5, 9-13, and 21 are under re-examination on the merits.
Any objection or rejection previously set forth in the FOA and not repeated herein has been overcome and/or withdrawn.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5, 9, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kuwahara et al. (US 2010/0239802; “Kuwahara”), in view of Fukuda et al. (US 2004/0241478; “Fukuda”) (both previously cited).
Siddhamalli et al. (US 2011/0241262; “Siddhamalli”) (previously cited) is optionally relied upon as an evidentiary reference providing in additional support of the rejection.
Regarding claim 1, Kuwahara discloses a coextruded multilayer tube [Abstract; 0089-0090] comprising an inner layer (balance layer, wherein the balance layer is an inner layer) formed from a resin composition including (a) hydrogenated styrene-based block copolymer, (b) hydrogenated styrene-based block copolymer, and (c) polyolefin-based resin [Abstract; 0001, 0009, 0025-0029, 0037-0038, 0042, 0044-0045, 0070, 0088-0089]. Block copolymers (a) and (b) are hydrogenated styrene-butadiene block copolymers, and each may be, inter alia A-B di-block copolymers or A-B-A tri-block copolymers [0042, 0044] (balance layer comprising a hydrogenated styrene-based thermoplastic elastomer; see spec [0015]).
The tube also includes an outer layer (adhesion layer, wherein the adhesion layer is an outer layer) coextruded with the inner layer, which may constitute the outermost layer of the tube, wherein no additional layers or intervening intermediate layers are present [0088-0091, 0093] (wherein the adhesion layer and the balance layer are in direct contact along a length of the tubing with no tie layer between the adhesion layer and the balance layer). The outer layer is suitably formed from, inter alia a styrene-based elastomer such as styrene-butadiene copolymer [0091-0092] (see MPEP 2131.02(II), alternatively MPEP 2144.07), or hydrogenated/modified derivatives thereof [0091].
The coextruded tube is suitable for use in medical applications and devices, and is capable of coupling to various connectors via solvent-bonding [Abstract; 0001, 0006, 0009-0010, 0024, 0095-0096].
With respect to the difference(s), Kuwahara is silent regarding the outer layer (adhesion layer) consisting of a non-hydrogenated styrene-based thermoplastic elastomer. However, as set forth above, Kuwahara [0091] recognizes/implies that the styrene-butadiene copolymer (elastomer) of the outer layer may be non-hydrogenated.
Fukuda discloses an extruded multilayer medical tube comprising a surface layer (I) which consists of a non-hydrogenated styrene/isoprene/butadiene/styrene (SIBS) block copolymer or a non-hydrogenated styrene/butadiene/styrene (SBS) block copolymer [Abstract; 0018, 0091, 0093, 0095, 0128-0130; Table 2 – Ex. 1-3]. Fukuda teaches that the surface layer – formed from either of said non-hydrogenated block copolymers – exhibits blood compatibility, antifouling properties, and excellent heat resistance [0091-0092, 0095].Further, Fukuda teaches multiple examples of said tube where the outer layer consists of non-hydrogenated styrene-based elastomer [Table 3 – Ex. 4-5, Comp. Ex. 4].
Furthermore, Fukuda teaches that use of the non-hydrogenated block copolymer to form the surface layer (i) allows the layer/block copolymer to crosslink (conjugated double bonds exhibit crosslinking functionality) via exposure to radiation and in the absence of crosslinking additives (agents and co-agents), resulting in a surface layer (i) exhibiting increased abrasion resistance and extremely low or no toxicity for medical applications, and if desired a degree of crosslinking to/with the adjacent layer (ii) formed from a partially-hydrogenated styrenic block copolymer elastomer [0009, 0025, 0030, 0035-0036, 0052, 0072, 0081-0082, 0088, 0090], allowing for increased adhesion between the layers while retaining the desired degree of tube flexibility and strength [0090].
One of ordinary skill in the art readily recognizes – as is explicitly disclosed by Fukuda set forth/cited above – that free conjugated double bounds (i.e. unsaturated double bounds, e.g. diene) of the styrene-butadiene block copolymer elastomer functional as molecular sites that will crosslink upon irradiation [Siddhamalli, 0021, 0029-0030].
Kuwahara and Fukuda are each directed toward extruded multilayer medical tubes comprising a surface layer formed from styrenic block copolymer elastomers and thereby 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 formed the outer layer of the coextruded tube of Kuwahara from a non-hydrogenated SIBS block copolymer or non-hydrogenated SBS block copolymer as taught by Fukuda, in order to confer the properties of good blood compatibility, excellent antifouling properties, and/or excellent heat resistance to the coextruded tube and/or to render the outer layer crosslinkable through irradiation; and optionally, to have irradiated the resultant coextruded tube to crosslink the outer layer to increase the abrasion resistance of the tube and/or adhesion between the inner and outer layer. Additionally/alternatively, see MPEP 2144.07 – the selection of a known material based on its suitability for its intended use has been held prima facie obvious by the Courts.
In accordance with the foregoing modification(s), the outer layer (adhesion layer) of the coextruded tube of Kuwahara (hereinafter “modified Kuwahara”) would have been formed from, and in particular consisted of, either of the non-hydrogenated styrene block copolymers disclosed by Fukuda (SIBS or SBS) (an adhesion layer consisting of a non-hydrogenated styrene-based thermoplastic elastomer), and optionally crosslinked via irradiation.
The coextruded tube of modified Kuwahara reads on the claimed intended use of the invention recited in the preamble (for administration of intravenous fluids) (see MPEP 2111.02(II)), and the outer layer reads on the limitation “wherein the adhesion layer is selected to be solvent bondable to acrylic-based materials”, given that the aforesaid SIBS and SBS block copolymers are non-hydrogenated, styrene-based thermoplastic elastomers, and in accordance with the species of block copolymer(s) defined in at least claims 2 and 3 as indicated hereinbelow, further in view of the grounds of rejection of claim 21 below.
The coextruded tube of modified Kuwahara reads on the co-extruded double-layer tubing defined by each and every limitation of claim 1.
Regarding claims 2-3, the non-hydrogenated SIBS or non-hydrogenated SBS block copolymer of the outer layer of the coextruded tube of modified Kuwahara reads on the claimed styrene-diene block copolymer (claim 2) and styrene-butadiene copolymer (claim 3).
Regarding claim 4, the rejection of claim 1 above reads on the tubing defined by claim 4 – each of the block copolymers (a) and (b) of the inner layer of the tube of modified Kuwahara are hydrogenated styrene-butadiene block copolymers, and each may be, inter alia A-B di-block copolymers or A-B-A tri-block copolymers.
Regarding claim 5, as set forth in the rejection of claim 1 above, the inner layer includes component (c), of which is suitably ethylene homopolymer [0070], i.e. polyethylene (wherein the balance layer further comprises a hydrogenated or saturated polyolefin).
Regarding claim 9, the rejection of claim 1 above reads on the tubing defined by claim 9 – Kuwahara does not disclose, teach, suggest, or otherwise imply that the coextruded tube comprises PVC. The coextruded tube of modified Kuwahara reads on “polyvinyl chloride free”.
Regarding claim 21, in view of the rejection of claim 1 above, it is noted that modified Kuwahara is silent regarding the outer layer of the two-layer tube (consisting of nonhydrogenated SIBS or SBS block copolymer) being soluble in an organic solvent enabling solvent bonding with acrylic-based material. However, it is noted that aforesaid non-hydrogenated block copolymers (inclusive of butadiene) which form the outer layer are identical to those disclosed by Applicant for the aforesaid purpose/exhibiting the aforesaid bonding capability – the spec indicates that the outer layer (adhesion layer) of the claimed/disclosed tubing may be made of a styrene/butadiene copolymer [0014, 0021], wherein further elaboration regarding the composition, properties, or other details of said styrene/butadiene copolymer is not provided.
Therefore, in light of the specification, and in the absence of a claimed species of solvent or strength/concentration thereof, it stands to reason – and there is a strong and reasonable expectation – that the non-hydrogenated, styrene-based, butadiene-inclusive block copolymer (SIBS or SBS) of the outer layer of the coextruded tube of modified Kuwahara would have necessarily exhibited solvent-bonding capability to acrylic-based materials. See MPEP 2112(IV) and (V), MPEP 2112.01(I) and (II), MPEP 2145, and MPEP 2145(I).
The coextruded tube of modified Kuwahara reads on the tubing defined by claim 21.
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kuwahara in view of Fukuda as applied to claim 1 above, further in view of Maule et al. (US 7,303,543; “Maule”) (previously cited).
Regarding claims 10-11, in view of the rejection of claim 1 above, Kuwahara teaches that the coextruded tube is suitable for use in infusion applications, and does not cause blocking (stickiness of the tubes) during/after being subject to sterilization [0010, 0095-0096, 0109]. Further, Kuwahara recognizes that the intended use(s) of the tube requires coupling capability to various connectors [0006, 0010], and discloses that the tube exhibits solvent-bonding capability for the aforesaid use/purpose [Abstract; 0009-0010, 0024, 0107]. As exemplified, the tube was bonded to, e.g. a polypropylene-based connector [0107].
Kuwahara, as modified above (modified Kuwahara) does not explicitly disclose the coextruded tube (resultant from the foregoing modification(s)) specifically being bound to a medical connector (claim 10) comprising an acrylic-based polymer (claim 11).
Maule teaches an infusion set for delivering a fluid, wherein the infusion set comprises a connector (i.e. a medical connector) made from an acrylic (plastic) or polypropylene which connects a fluid tubing to a cannula housing [Abstract; col. 1 ln. 6-35; col. 4 ln. 60–col. 5 ln. 21; col. 6 ln. 42-48; Figs. 1-2 and 4] (see MPEP 2144.07). Maule is directed toward use of medical tubing in infusion applications.
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 utilized the coextruded tube of modified Kuwahara in the infusion set of Maule – said alternatively, to have connected the coextruded tube of modified Kuwahara (set forth in rejection of claim 1 above) to the acrylic or polypropylene connector of Maule by, e.g. solvent-bonding – in order to have achieved the predictable result of an infusion set exhibiting non-blocking property during/subsequent sterilization, and/or because the coextruded tube would have been readily recognized as suitable for and capable of said intended use (MPEP 2144.07). The infusion set(s) resultant from the aforesaid modification reads on the infusion set defined by claim 10 in accordance with the tubing defined by claim 1. The infusion set resultant from the aforesaid modification, wherein said connector is formed from acrylic, reads on the infusion set defined by claim 11.
Regarding claim 12, in view of the rejection of claim 10 above, the non-hydrogenated SIBS block copolymer or non-hydrogenated SBS block copolymer of the outer layer (adhesion layer) of the coextruded tube of modified Kuwahara reads on the claimed styrene-diene block copolymer.
Regarding claim 13, in view of the rejection of claim 10 above, the rejection of claim 4 above is incorporated herein by reference and reads on the infusion set defined by claim 13.
Response to Arguments
Applicant’s arguments presented on pp. 5-7 of the Remarks filed 24 November 2025 have been considered but are moot as the rejection under 35 U.S.C. 103 previously set forth in the FOA to which the arguments are directed has been withdrawn. New grounds of rejection under 103 are set forth above, of which are based on an alternative, specific interpretation of Kuwahara, taken in view of additional disclosure and teachings of Fukuda not previously cited or relied upon in the FOA.
Pertinent Prior Art
The following constitutes prior art which is not relied upon herein, but is considered pertinent to the claimed invention and/or written description thereof. The prior art is purposely made of record hereinafter to facilitate compact/expedient prosecution, and consideration thereof is respectfully suggested.
US 2014/0037880 to Siddhamalli et al. – discloses a bilayer flexible tube including first and second polymer layers, said first layer defining the inner layer and comprising a hydrogenated SBS block copolymer (i.e. SEBS), and said second layer defining the outer layer and comprising any reasonable styrenic block copolymer with the proviso that the first and second layers are different materials [Abstract; Fig. 1; 0016-0017, 0025-0027, 0029, 0031, 0037]
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