DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office action is in response to the applicant’s communication filed 12/05/2025.
Status of the claims:
Claims 1 – 4, 7, 11, and 21 – 26 are pending in the application.
Claim 2 and 26 are withdrawn.
Claim Objections
The objections to claim 1 in the previous action dated 10/02/2025 have been withdrawn in light of the Applicant’s amendments filed 12/05/2025. Specifically, the objections to claim 1 regarding the phrases “wherein molecules of the extruded polymer material extending circumferentially around the outer surface”, “an outer surface of the inner tube body”, and “the proximal portion”, have been withdrawn as the appropriate corrections have been made.
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.
The rejection of claim 1 under U.S.C 35 102 with respect to Wilkins, recited in the previous action dated 10/02/2025 have been withdrawn in light of the Applicant’s arguments filed 12/05/2025 as Wilkins is silent regarding wherein “substantially all of the molecules extend circumferentially”. However, a new rejection has been set forth below under Wilkins and Gielenz, wherein Gielenz is relied upon for teaching the limitations above. It should be understood that this is the same rejection used in the last Office Action to rejection claims 3, 24, and 25.
Claims 1, 3, 4, 11, and 21 – 25 are rejected under 35 U.S.C. 103 as being unpatentable over Wilkins (US 2008/0177227 A1) (previously cited) and in view of Gielenz et al (US 2010/0121312 A1) (previously cited) and Beisel (US 5,947,940).
Regarding claims 1, 3, 24, and 25, Wilkins discloses a catheter (catheter system 10) (paragraph [0015] and Figs. 1 – 3) comprising:
a catheter body (catheter 20) having proximal and distal ends and including an inflation conduit (shaft 28 and inner member 34) having a length extending between the proximal and distal ends of the catheter body (paragraph [0015] and Figs. 2 and 3);
an inflatable balloon (balloon 22) coupled to the inflation conduit adjacent the distal end of the catheter body (Figs. 2 and 3),
wherein the inflation conduit (shaft 28 and guidewire lumen 34) includes
an inner inflation tube (inner member 34) including an inner tube body (body of inner member 34) having an outer surface, an inner surface defining a guidewire lumen (guidewire lumen 32) (paragraphs [0015 – 0017] and Figs. 2,3), a reinforced longitudinal portion (portion of inner member 34 within the balloon), and a proximal longitudinal portion (portion of inner member 34 that is proximal to the balloon) that is proximal of the reinforced longitudinal portion (Fig. 2), and
an extruded polymer material (sleeve 35) coupled to the outer surface of the reinforced longitudinal portion of the inner tube body (paragraphs [0018 – 0019] and Figs. 2,3), and
an outer inflation tube (shaft 28) surrounding the inner inflation tube to define an annular inflation lumen (inflation lumen 64) between an inner surface of the outer inflation tube and an outer surface of the inner tube body (paragraph [0015] and Figs. 2,3), wherein the inflation lumen is in fluid communication with the inflatable balloon (paragraph [0015] and Figs. 2,3), wherein the reinforced longitudinal portion (portion of inner member 34 within the balloon) of the inner tube body is received in the inflatable balloon (the portion of the inner member 34 within the balloon is within the balloon),
wherein the reinforced longitudinal portion (portion of inner member 34 within the balloon) of the inner tube body has a thickness less than a thickness of the proximal portion (portion proximal of the balloon) of the inner tube body (Examiner’s note: as shown in Fig. 3, the portion of the inner member 34 in the balloon is step down, and that portion has a thickness less than the rest of the inner tube body (i.e., the proximal portion of inner member 34),
wherein the extruded polymer material strengthens the reinforced longitudinal portion of the inner tube body against radial compression forces imparted on the reinforced longitudinal portion by fluid pressure within the inflatable balloon when the inflatable balloon is being inflated (Examiner’s note: the sleeve 35 adds material to the portion of the inner member 34 (i.e., the reinforced longitudinal portion), and added material can only strengthen the inner member 34 (i.e., the inner tube body) against radial compression forces imparted thereon).
However, Wilkins is silent regarding (i) [claims 1, 3, 24, and 25] wherein substantially all molecules of the extruded polymer material are aligned and extend circumferentially around the outer surface of the inner tube body wherein the extruded polymer material comprises a ribbon of polymer material spirally wrapped around the reinforced longitudinal portion of the inner tube body at a constant pitch.
As to the above, Gielenz teaches a method of making a section of a catheter tube (catheter shaft formed by screw-type winding of the film strips – paragraph [0050]; which equates to the sleeve 35 of Wilkens as both are tubular members made out of a polymer) defining a guidewire lumen (paragraph [0014]), wherein the catheter tube comprises an extruded polymer material (film strip) (paragraphs [0021] and [0038]), and wherein the extruded polymer material comprises a ribbon of polymer material spirally wrapped around the reinforced longitudinal portion of the inner tube body at a constant pitch (Examiner’s note: a ribbon is defined as a long narrow strip of material; and the film strip (as shown in Fig. 1) is a long narrow strip that is spirally wrapped at a constant pitch).
Additionally, Beisel teaches a method of reinforcing a catheter to prevent the liminal collapse and tensile failure thereof via a helically wrapped ribbon of extruded polymer (abstract, col. 7 lines 55 – col. 8 lines 10, col. 8 lines 20 – 30)
The Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have the sleeve 35 (i.e., the extruded polymer) of Wilkins be formed from by spirally wrapping a ribbon of polymer material around the reinforced longitudinal portion of the inner tube body at a constant pitch, as the particular technique of forming a tubular layer around a shaft is known and recognized as part of the ordinary capabilities of one skilled in the art, based on the teachings of Gienlenz and Beisel, separately, and one of ordinary skill in the art would have been capable of applying this known technique to form the known device (i.e., the sleeve 35 / the extruded polymer material), and the results of the process would have been predictable, wherein the device would be able to function as intended.
Regarding claim 4, as discussed above, it would have been obvious to modify the reinforced portion of Wilkins to be circumferentially extruded as taught by Gienlenz and Beisel. Additionally, Wilkins discloses wherein the ribbon of polymer material (sleeve 35 of Wilkens formed as a ribbon) comprises a first polymer material (polyurethane) and a second polymer material (polyamide) having a stiffness greater than a stiffness of the first polymer material (Examiner’s note: as stated in paragraph [0018] the sleeve 35 is comprised of polyamide and polyurethane, and polyamide has a stiffness greater than polyurethane). Therefore the combination makes obvious the limitation above.
Regarding claim 11, as discussed above, it would have been obvious to modify the reinforced portion of Wilkins to be circumferentially extruded as taught by Gienlenz and Beisel. Additionally, Wilkins discloses wherein the inner tube body (inner member 34) consists of polymer materials (paragraph [0017]).
Regarding claim 21, as discussed above, it would have been obvious to modify the reinforced portion of Wilkins to be circumferentially extruded as taught by Gienlenz and Beisel. Additionally, Wilkins discloses wherein an entirety of the reinforced longitudinal portion (portion of inner member 34 within the balloon) is within the inflatable balloon (the portion of the inner member 34 within the balloon is within the balloon).
Regarding claim 22, as discussed above, it would have been obvious to modify the reinforced portion of Wilkins to be circumferentially extruded as taught by Gienlenz and Beisel. Additionally, Wilkins discloses wherein the inner tube body further includes a tie layer (adhesive) radially between the extruded polymer material (sleeve 35) and the inner tube body (inner member 34), wherein the tie layer couples the extruded polymer material to the inner tube body (Examiner’s note: as stated in paragraph [0019] the sleeve 35 is bonded to the inner member 34 via an adhesive; in order for the adhesive to bond the sleeve 35 to the inner member 34, the adhesive has to be a layer radially between the sleeve 35 and the inner member 34).
Regarding claim 23, as discussed above, it would have been obvious to modify the reinforced portion of Wilkins to be circumferentially extruded as taught by Gienlenz and Beisel. Additionally, Wilkins discloses wherein the inner tube body (inner member 34) comprises a polymer (HDPE), wherein the extruded polymer material (sleeve 35) is stiffer than the polymer of the inner tube body (Examiner’s note: as stated in paragraph [0017] the sleeve 35 is made up of PET which is stiffer than HDPE).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wilkins (US 2008/0177227 A1) (previously cited) in view of Gielenz et al (US 2010/0121312 A1) (previously cited) and Beisel (US 5,947,940), as applied to claim 1 above, and further in view of Samuelson et al (US 6,165,166) (previously cited).
Regarding claim 7, as discussed above, the combination of Wilkins, Gielenz, and Beisel teaches the catheter of claim 1.
However, the combination above is silent regarding (i) wherein the inner tube body comprises multiple layers
As to the above, Samuelson teaches, in the same field of endeavor, a catheter (balloon catheter 220) comprising a catheter body (balloon catheter 220) with an inflation conduit (outer catheter tube 222 and inner catheter tube 210) and an inflatable balloon (balloon 224) (abstract, col. 9 lines 3 – 7, col. 9 lines 32 – 45, and Fig. 2) wherein the inflation conduit (outer catheter tube 222 and inner catheter tube 210) includes an inner inflation tube (inner catheter tube 210) including an inner tube body (inner catheter tube 210) comprising multiple layers (col. 9 lines 45 – 55). Samuelson recites, in col. 2 lines 50 – 55, wherein catheter tubing should possess a combination of the desired characteristics of strength, pushability, torqueability, bendability and lubricity, wherein such a combination of characteristics has not been achieved satisfactorily with tubing comprising only a single material, and further, in col. 3 lines 46 – 51, that the above objectives and other objectives apparent to those skilled in the art upon reading this disclosure are attained by the present invention which is drawn to trilayered tubing; therefore, Samuelson teaches the purpose of having a tri-layer inner tube is to achieve a combination of the desired characteristics of strength, pushability, torqueability, bondability and lubricity.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the inner tube body of Wilkins to incorporate a tri-layer configuration, based on the teachings of Samuelson, for the purpose of obtaining a combination of strength, pushability, torqueability, bondability and lubricity for the catheter tube (col. 2 lines 50 – 55 and col. 3 lines 46 – 51 – Samuelson).
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive. More specifically:
With respect to Applicant’s argument that “The Office has provided no proper reason or motivation as to why a POSITA would have completely changed the method of forming the sleeve 35 in Wilkins to render claim 1 obvious.” as stated in the previous rejection of claim 3 and the rejection of claim 1, it is obvious and well within the purview of one of ordinary skill in the art to utilize a known method of manufacturing of a polymer layer / catheter to make the extruded polymer reinforcement layer on the device of Wilkins, and one of ordinary skill in the art would have a reasonable expectation of success with such a modification as the results would be predicable and the modified device would operate as intended. Therefore Applicant’s arguments are not persuasive.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Andrew Restaino/Primary Examiner, Art Unit 3771