DETAILED ACTION
This Office action details a non-final action on the merits for the above referenced application No. Claims 1-5, 7-15, and 19-21 are pending in this application.
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 .
Status of Claims
Claims 1 and 19 are amended. Claims 6, 16-18, and 22 are cancelled.
Response to Amendment
The claim amendments filed on 11 Jul. 2025 have been entered.
Response to Arguments
In view of Applicants amendments, the rejection of claims 1-5, 7-15, and 18-20 under 35 USC 103 as being unpatentable over Hopkins et al. (US 5,948,489 A; published 1999), in view of Thistle et al. (US 2006/0058867 A1; published 16 Mar. 2006) and Koske et al. (WO 2012/047279 A1; published 12 Apr. 2012) is withdrawn.
In view of Applicants amendments, the rejection of claims 17 and 22 under 35 USC 103 as being unpatentable over Hopkins et al. (US 5,948,489 A; published 7 Sep. 1999), in view of Thistle et al. (US 2006/0058867 A1; published 16 Mar. 2006) and Chuahan et al. (Enc. Biomed. Polymers Polymeric Biomat.; published 2015), in view of Park et al. (Gut and Liver; published 12 Feb. 2019) is withdrawn.
New Grounds of Rejection
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-5, and 7-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hopkins (US 5,948,489 A; published 7 Sep. 1999), in view of Chuahan et al. (Enc. Biomed. Polymers Polymeric Biomat.; published 2015) and Lim et al. (US 2002/0187288 A1; published 12 Dec. 2002; see attached 892).
Hopkins teaches a catheter (medical device) having extruded, flexible, pliable and compliant marker band (see title). Hopkins et al. teach that the compliant marker band comprises a heat shrinkable plastic material having tungsten particles which are no greater that 2 micron in size such that the marker band is radiopaque throughout (see abstract; Figs. 1-3). Tungsten particles are preferred for its low cost, high radiopaqueness and its availability in particles as small as 0.9 microns. The plastic material has heat shrinkable characteristics so that when the marker band is cut it can be heat shrunk a catheter or a sheath of guidewire eliminating the need for heat or adhesive bonding. Polyurethane may be used to provide a more compliant or radiopaque tube. The marker band material comprises between 10 and 80 percent weight metal particles and 90 and 20 percent weight plastic material. In addition to the use of thin slices as small as 0.5 mm of extruding tube as marker bands, and length of tube approx. 2 cm (40× thickness) can be used (see col. 2). As for the metal particles, the smaller the size the better and preferably not higher than 2 microns. Hopkins et al. teach that the preferred thickness of the marker band is 0.5 mm. The extruding tube can be cut to any desired length (see col. 3).
Hopkins does not teach a medical component or marker band wherein the polyurethane is a linear, thermoelastic polyurethane and comprises the reaction product of: a) from 20 wt% to 40 wt% based on the total weight of the polyurethane of diisocyanate, b) from 50 wt% to 70 wt% based on the total weight of the polyurethane, of a polymeric aliphatic diol wherein the polymeric aliphatic diol comprises polysiloxane diol and a polycarbonate diol, and c) from 2 to 12 wt% of a chain extender. Hopkins et al. do not expressly teach a length of from 5 to 100 mm and a width of from 1 to 6 mm. Hopkins does not disclose a radiopacifier having an average diameter of from 25 nm to 1,000 nm or an average diameter of from 25 nm to 600 nm or disclose a thickness from 0.14 to 0.3 mm or disclose a length of from 10 to 40 times its thickness. Hopkins does not expressly teach a polyurethane further comprising an end group comprising a polysiloxane or a polyurethane that consists of a backbone that consists of a residue of a diisocyanate, a residue of polysiloxane diol, a residue of a polycarbonate diol and a residue of a chain extender.
Chuahan et al. teach polyurethanes: silicone-polyurethane copolymers and (see title). Chuahan et al. teach that silicone elastomers are well established as biocompatible and biostable material. This stability coupled with low hardness, low modulus, and high ultimate enlongation makes them excellent candidates for polyurethane modification. The most promising candidates are PursilTM and CarbosilTM (see pg. 6713). (Carbosil comprises approximately 25-45 wt% of diisocyanate, 15-25 wt% silicone diol, 30-50 wt% polycarbonate diol, and 5-15 wt% chain extender). The PSiU copolymers consisted of MDI, 1,4-BD, and OH terminated PDMS. It has been reported that silicone acts synergistically with both polycarbonate- and polyether-based polyurethanes to improve in vivo and in vitro stability. Several copolymers have shown increased resistance to metal-ion induced oxidation and environmental stress cracking. The covalently bonded silicon seems to protect the polymer soft segment from oxidative degradation (see pg. 6714). Chuahan et al. teach PurSil and CarboSil TSPUs that have medium to high strength copolymers, silicone end groups and mid-blocks and polyether co-soft segments (table 1). Chuahan et al. teach linear copolymers (see Fig. 4; Scheme 4). Chuahan et al. teach chronically implanted medical devices including grafts, balloons, shunts and stents (see pg. 6721).
Lim et al. teach a medical device formed of silicon-polyurethane (see title). Lim et al. teach a medical device an in particular an intracorporeal device for therapeutic or diagnostic use (see abstract). Lim et al. teach Carbosil as a thermoelastic urethane copolymer containing silicon in the soft segment. It is synthesized through a multistep bulk synthesis in which PDMS is incorporated into the polymer segment with an aliphatic hydroxy-terminated polycarbonate. The hard segment consists of an aromatic diisocyanate, MDI with a low molecular weight glycol extender. The polymer is terminated with a silicon end group. Shore hardness of the preferred silicon polyurethane material is about 70A to about 90A. Lim et al. teach improved flexibility, high hydrolytic and oxidative stability including resistance to oxidative stress cracking ([0007]-[0008]). Lim et al. teach a stent cover on the outer surface of a stent formed from silicon polyurethane. The stent cover length may be selected to fit a variety of conventionally sized stents with a typical diameter of about 2 mm to about 10 mm ([0018]-[0022]). Lim et al. teach a catheter balloon ([0022]-[0023]). Lim et al. teach a diagnostic agent impregnated in the silicon polyurethane ([0023]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the composition of Hopkins (highly radiopaque marker band and medical device comprising marker band wherein the marker band comprises e.g. 20 wt% polyurethane and about 80 wt% radiopacifier tantalum nanoparticles wherein the marker band has a thickness of from about 0.025 to 1 mm (0.5 mm) and wherein the nanoparticles have a diameter of the smaller the better and not higher than 2 micron) so that the thermoelastic polyurethane is a linear thermoelastic Carbosil polyurethane (comprises an end group comprising a polysiloxane and consists of a backbone that consists of a residue of a diisocyanate, a polysiloxane diol, a residue of polycarbonate diol, and a residue of a chain extender) as taught by Hopkins et al., Chuahan et al., and Lim et al. because the Carbosil thermoelastic polyurethane would have expected to advantageously provide an ideal biomaterial with improved in vivo and in vitro stability, flexibility, and showing increased resistance to metal ion induced oxidation and environmental stress cracking. The average particle diameter is a result effective variable that a person of ordinary skill in the art would have been motivated to optimize at the time of invention. A person of ordinary skill in the art would have arrived at an average particle diameter of from 25 nm to 1000 nm or from 25 nm to 600 nm through routine experimentation in order to provide optimal radiopacity. The length, width, and thickness of the medical device are a result-effective variables that a person of ordinary skill in the art would have been motivated to optimize at the time of invention. A person of ordinary skill would have arrived at a length of from 5 to 100 mm and width of from 1 to 6 mm and a length 10-40× thickness order to arrive at lengths, widths, and thicknesses suitable for conventional stents and other medical devices.
Claim(s) 1-5, 7-15, and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hopkins (US 5,948,489 A; published 7 Sep. 1999), in view of Chuahan et al. (Enc. Biomed. Polymers Polymeric Biomat.; published 2015) and Lim et al. (US 2002/0187288 A1; published 12 Dec. 2002; see attached 892), in further view of Thistle et al. (US 2006/0058867 A1; published 16 Mar. 2006) and Park et al. (Gut and Liver; published 12 Feb. 2019).
Hopkins teaches as discussed above.
Hopkins does not further teach a suture retention strength as measured on a 30 mm length × 3 mm width × 0.17-0.2 mm thick strip of from 3 to 9 N or a medical component having an elongation at break of at least 250% and at most 450%. Hopkins does not further teach a device that are having a plurality of medical components attached via a suture or a method of forming a medical device comprising attaching the component to the device via a suture and optionally without adhesive.
Chuahan et al. teach as discussed above.
Lim et al. teach as discussed above.
Thistle et al. teach an elastomeric radiopaque adhesive composite and prosthesis (see title). Thistle et al. teach catheters and stents (see [0004]). Thistle et al. teach an elastomeric radiopaque composition that may include biocompatible elastomeric matrix and a radiopaque material distributed therein in amounts sufficient to produce a radiopaque image ([0016]). Thistle et al. teach a hybrid prosthesis comprising an bonding agent made of urethanes (see [0016]-[0019], [0077]). The radiopaque material and the elastomeric material are introduced to a solvent. The solid particles are dissolved and dispersed accordingly. As the elastomer cures, the radiopaque particles suspended therein are locked in place within the elastomeric matrix ([0074]). Thistle et al. teach that the hybrid graft mat be frictionally secured to the support structure. Fig. 5
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shows the ends of the support structure 4 being secured top the hybrid graft 38 by sutures 39 ([0096]). The PTFE tube is coated with a bonding agent which includes an elastomeric matrix. The elastomeric matrix is made of anywhere from about 1 % to about 15% corethane® urethane range, 2.5 W30 in DMAc. The assembly is placed into an oven and heated in a range of about 300oC-500oC for about 5-30 min (connotes evaporation) ([0088]). Solvents include dimethylacetamide ([0067]). Thistle et al. teach polyurethanes of shore 80A hardness (see [0062]-[0064]).
Park et al. teach a novel high visibility radiopaque tantalum marker for biliary self-expandable metal stents (see title). Park et al. teach that all stents of nitinol or stainless-steel alloys and these allows may provide radiological visibility (see pg. 366). Tantalum is a radiopaque metal that is mainly use in vascular stents and numerous studies have reported that it improves stent radiopacity. Létwouneau-Guillon evaluated the imaging characteristic of Nitinol stents with distal tantalum marker and found that tantalum improved the stent visibility on X-ray images. Tantalum wires with diameter (0.6 mm) were found more radiopaque. Many tantalum containing medical devices have been approved by the FDA (pg. 366). Park et al. teach a stent diameter of 10 mm and length of 60 mm (see pg. 369). Tantalum is available in the form of nanoparticles, which enable it to be applied to stent by spraying. The tantalum markers on the Nitinol stents examined had a diameter of 2 mm (pg. 370). Park et al. teach a silicone-based membrane (pg. 371).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Hopkins so that one or more of the marker bands are attached to the medical device such as a stent using a suture to arrive at a medical device wherein one or more marker bands are attached to the stent via a suture and optionally without adhesive as taught by Thistle et al. because the suturing would have been expected to enable attachment of additional layers such as a textile layer and/or enable secure attachment of the marker device that may swell or change size due to a change in conditions. A composition and its properties are inseparable. Hopkins, Chuahan et al. and Thistle et al. teach, suggest, and motivate marker band material made of the same material as disclosed in the examples of the instant specification – Carbosil and tantalum nanoparticles – where the marker band material is attached to a stent by suture. Accordingly, the marker band material must have a suture retention strength as measured on a 30 mm length × 3 mm width × 0.17-0.2 mm thick strip of from 3 to 9 N and an elongation at break of at least 250% and at most 450%. See also MPEP 2144.05.II.
Applicants Arguments
Applicants assert that Hopkins requires heat shrinkable plastic material to secure his marker band. For the instant invention, melting, heat shrinking or other bonding processes of the prior art are not desirable because they can introduce thermal stress to the medical component and decrease it fatigue lifetime. The polyurethanes of Hopkins differ in composition. Thistle frustrates the purpose of Hopkins. Thistle’s invention is an adhesive composition. The person of ordinary skill in the art would not have any reasonable expectation in being able to secure the marker band itself by means of a suture or without aid of adhesive. A person of ordinary skill in the art seeking to solve the problem of attaching radiopaque medical components to medical devices without the use of melting, heat shrinking, or other bonding processes would not modify the heat shrinkable material of Hopkins with the adhesive of Thistle and further be motivated to modify the polyurethane based on the teachings of the lightly loaded, blow-molded composites of Koske.
Applicant's arguments filed 11 Jul. 2025 have been fully considered but they are not persuasive. Hopkins provides marker bands for use on medical devices in general, the marker bands made radiopaque throughout by using for example tantalum nanoparticles. Regarding the plastic material, Hopkins teaches plastic material in general; preferred plastic material includes polyurethane plastic material. Although polyurethane plastic material is described as a preferred embodiment; Hopkins is not limited to its preferred embodiments. Regarding attachment of the marker band to the medical device, Hopkins teaches that the plastic material preferably has heat shrink characteristics thereby eliminating the need for heat or adhesive bonding.
Chuahan and Lim teach, suggest and motivate Carbosil as a polyurethane for use in chronically implanted medical devices and prostheses that include stents. Carbosil is a linear, thermoplastic polyurethane comprising a backbone that comprises a reaction product of diisocyanate, polyaliphatic diol comprising a polysiloxane diol and a polycarbonate diol and a chain extender each of which falling in claimed weight percentages. Chuahan and Lim teach and suggest Carbosil as an ideal biomaterial having the following properties: improved in vivo and in vitro stability and flexbility; and increased resistance to metal ion induced oxidation and environmental stress cracking. A recognized advantage is the strongest reason to combine. It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify Hopkins so that the polyurethane in the marker band is a Carbosil polyurethane because the Carbosil polyurethane would have been expected to provide an ideal biopolymer advantageously having improved in vitro and in vivo stability and flexibiltiy, resistance to metal ion oxidation and environmental stress cracking. Lim, Thistles, and Park teach, suggest and motivate attaching radiopaque material to stents that expand and change size, the radiopaque material enabling visualization of the stent. It would have been obvious to a person of ordinary skill in the art to further modify Hopkins so that one or more marker bands get attached to a stent because it would have been expected to enable visualization of chronically implanted stent material. Thistle teaches, suggests and motivates adding additional layers to the stent such as textile layer being naturally porous allowing ingrowth and assimilation. It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify Hopkins so that the marker band gets attached to the obvious stent or other medical device by sutures optionally without additional adhesive as taught by Hopkins and Thistle because the sutures would have been expected to enable robust attachment of the marker band to stent material that changes size and/or enable attachment of additional layers to the stent or other medical device such as a textile layer.
Conclusion
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618