DETAILED ACTION
This Office action details a 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 1-5, 7-15, and 19-21 are previously presented. Claims 6, 16-18, and 22 are cancelled.
Response to Amendment
The amendments filed on 27 Jan. 2026 have been entered.
Response to Arguments
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 2022) for the reasons cited in the Office action filed on 31 Oct. 2025.
Applicants Arguments
Applicants assert that the motivation for settling upon Carbosil as a worthy substitute for Hopkins’ plastic material is not credible and is a result of hindsight reasoning. Hopkins provides few guideposts for selecting a suitable material including the polyurethane class. Neither Chuahan nor Lim make any mention of heat shrink material. Chuahan mentions that incorporating siloxane into polyurethanes yield great improvements in their resistance to shrinkage. A person of ordinary skill would not find anything in Hopkins or Chuanhan that would motivate substitution of Hopkins’ material with one that is taught to have resistance to only material that Hopkins’s specifies or prefers. Lim desires the polyurethane stent cover to expand with underlying stent. Hopkins provides no other way to attach his marker band desiring the use of heat shrink plastic to eliminate the need for bonding. The materials of Chuahan and Lim are incompatible with the function of Hopkins. Modifying Hopkins as proposed would render Hopkins inoperable for its intended function. There is no disclosure in the prior art that any material specified in Chuahan and Lim can function as heat shrinking plastic material. The proposed substitution improperly assumes functional equivalence among thermoplastic polyurethanes, an assumption refuted bv the examples in the instant application. The Office fails to state why a PHOSITA would pick out the specific linear, thermoplastic polyurethane claimed to replace the plastic material of Hopkins as opposed to picking out any other of the countless possible polymers. In instant examples 1-3 it is demonstrated that a silicon-polycarbonate polyurethane has relatively little decrease in its mechanical properties relative to a polycarbonate urethane. The limitations of thickness, radiopacifier content and radiopacifier average particle diameter are not mere result effective variables or the result of routine experimentation.
Applicant's arguments filed 27 Jan. 2026 have been fully considered but they are not persuasive. At col. 1, Hopkins describes the invention as a compliant radiopaque marker band that comprises a flexible plastic carrier material having mixed therein minute particles of metal. At col. 2 Hopkins teaches that the purpose of the invention is to provide highly radiopaque marker bands for use on or in a catheter or guidewire sheath. Regarding heat shrinkable characteristics, at col. 2, Hopkins only teaches that preferably the plastic material is one that has heat shrink characteristics. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Regarding radiopacifier average particle diameter, at col. 3 Hopkins teaches that as for the metal particles, the smaller the size the better. In addition, Hopkins teaches and motivates tungsten particles approximately 0.9 micron in size. Accordingly, a person of ordinary skill in the art would have had adequate reason and motivation to arrive a radiopacifier that is present as particles having an average diameter of from 25 nm to 1000 nm. Regarding thickness, Hopkins, in addition to teaching a thickness range, teaches a preferred thickness that is 0.5 mm. Accordingly a person of ordinary skill in the art would have had adequate reason and motivation to arrive at the medical component having the thickness of 0.5 mm. Regarding radiopacifier content, Hopkins teaches that the marker band preferably comprises between 10 and 80 weight percent of the metal particles that provide radiopacity. Accordingly, a person of ordinary skill in the art would have had adequate reason and motivation to arrive at a marker band medical component having 60 to 92 wt% of a radiopacifier to provide radiopacity. Regarding the flexible plastic carrier material, Hopkins teaches polyurethanes as preferred material since it is relatively flexible such that the whole catheter could be made of polyurethane tube having minute tungsten particles embedded therein.
Chuahan describes Carbosil as thermoplastic silicone polyurethane biomaterial. According to Chuahan, Carbosil contains silicone end groups attached to a polyurethane mid-block that Hopkins describes as preferable material with heat shrink characteristics. Chuahans’ teaching at pg. 6716 that incorporating siloxane into PUs yields great improvements in resistance to shrinkage is not a teaching that the Carbosil having a preferable polyurethane mid-segment does not have the heat shrink characteristics preferred by Hopkins. Chuahan describes Carbosil an advantageous and ideal polyurethane plastic material for use in medical devices including stents. Chuahan teaches that Carbosil has improved in vivo and in vitro stability and increased resistance to metal ion oxidation. Silicone copolymerization has been shown to reduce hydrolytic degradation of the carbonate linkage. A recognized advantage is the strongest reason to combine. Since Chuahan teaches the Carbosil contains the preferred polyurethane with advantageous silicone end blocks for use in medical devices, the application of Chuahan cannot be construed as hindsight analysis.
Lim teaches medical devices including stent covers and catheter balloons formed from silicone-polyurethane. The medical devices have excellent biostability, strength and flexibility. At col. 2, Hopkins teaches a balloon catheter having metal particles therein so that the balloon is radiopaque. At [0007], Lim teaches Carbosil as a suitable thermoplastic elastomer having the preferred polyurethane. At [0023], Lim teaches adding a diagnostic agent to the silicone polyurethane. A recognized advantage is the strongest reason to combine. Since Lim teaches the Carbosil contains the preferred polyurethane with advantageous silicone end blocks for use in medical devices such as a balloon catheter, the application of Lim cannot be construed as hindsight analysis.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the medical device of Hopkins so that preferred polyurethane flexible plastic material is a silicone polyurethane plastic material such as Carbosil because the preferred silicone polyurethane plastic material such as Carbosil would have been expected to enable excellent biostability, strength and flexibility.
Expected beneficial results are evidence of obviousness. Based on the cited prior art, a person of ordinary skill in the art would have expected the silicone polyurethane plastic material to show improved strength and flexibility when compared to a polycarbonate polyurethane.
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 2022), 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) for the reasons cited in the Office action filed on 31 Oct. 2025.
Applicants Arguments
Applicants assert that Thistle does not teach or suggest standalone thin radiopaque polymer band intended to bear puncture. The person of ordinary skill in the art would thus not have any reasonable expectation of success in being able to secure the marking band itself by means of a suture or without the aid of a adhesive.
Applicant's arguments filed 27 Jan. 2026 have been fully considered but they are not persuasive. Hopkins, Chuahan, and Lim are not deficient for the reasons discussed above. Thistle provides for a medical device comprising a flexible radiopaque plastic layer that gets secured by a suture. Thistle teaches adding an additional layer to the stent such as a textile layer being naturally porous allowing in growth and assimilation. The instant claims do not exclude a medical component having additional layers secured a medical device by suturing. In addition, suturing in addition to thermoplastic molding adhesion would have been expected to provide robust attachment to a medical device that changes shape depending on conditions.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN R DONOHUE whose telephone number is (571)270-7441. The examiner can normally be reached on Monday - Friday, 8:00 - 5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on (571)272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618
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