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 Arguments
Applicant's arguments filed August 3, 2026 have been fully considered but they are not persuasive.
Applicant argues Hanai merely teach adhesion of the resin to the reinforcement structure, not adhesion of the resin to the inner and/or outer layer.
Examiner respectfully disagrees with this assertion noting Hanai teaches the reinforcement structure is coated in a film ([0079]- the metal wire 2A is dipped into a resin solution for forming the resin coating film 2B and the resin solution adhering to the metal wire 2A is then hardened may be employed) in order to reduce deformation of the body of the medical instrument (See Figs. 3 and 4) and avoid forming a hole or kink in the medical instrument [0089]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Otake to include a film-coated reinforcement structure as taught by Hanai with reasonable expectation of success to reduce deformation of the body of the medical instrument (See Figs. 3 and 4) and avoid forming a hole or kink in the medical instrument [0089].
The combination of the film-coated reinforcement structure of Hanai and the encapsulation steps of Otake taught above meets the instant limitations of bonding, adhesively or chemically, the reinforcement structure to i) the inner layer, ii) the outer layer, or iii) both, via a film coating as the components are bonded together by way of the film coating on the reinforcement structure.
Examiner further notes Hanai shows the reinforcement structure (Figs. 1, 3, and 4- metal wire 2A coated in resin coating film 2B forming linear member 2) embedded in the outer layer (Figs. 1, 3, and 4- outer polymeric elastomer layer 4) and bonded to inner layer tube (Figs. 1, 3, and 4- inner layer tube 1) by way of (via) the film coating (Figs. 1, 3, 4- resin coating film 2B).
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.
Claims 1-9 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Otake et al (PGPub 2016/0136387 cited in IDS) in view of Hanai et al (PGPub 2019/0381216 with foreign priority to June 1, 2017).
Regarding Claim 1 and 9, Otake teaches a method of manufacturing a reinforced catheter (Abstract), comprising:
applying a reinforcement structure (Fig. 2- reinforcement member 8) over an inner layer (Fig. 2- inner layer 6) such that the reinforcement structure at least partially encapsulates the inner layer (Fig. 2; [0037]); and
applying an outer layer (Fig. 2- outer layer 7) over the reinforcement structure such that the outer layer encapsulates both the inner layer and reinforcement structure [0037].
Otake does not specify the reinforcement structure comprises a film coating.
Hanai teaches an alternative method of manufacturing a reinforced catheter (Abstract) wherein the reinforcement structure is coated in a film ([0079]- the metal wire 2A is dipped into a resin solution for forming the resin coating film 2B and the resin solution adhering to the metal wire 2A is then hardened may be employed) in order to reduce deformation of the body of the medical instrument (See Figs. 3 and 4) and avoid forming a hole or kink in the medical instrument [0089]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Otake to include a film-coated reinforcement structure as taught by Hanai with reasonable expectation of success to reduce deformation of the body of the medical instrument (See Figs. 3 and 4) and avoid forming a hole or kink in the medical instrument [0089].
The combination of the film-coated reinforcement structure of Hanai and the encapsulation steps of Otake taught above meets the instant limitations of bonding, adhesively or chemically, the reinforcement structure to i) the inner layer, ii) the outer layer, or iii) both, via a film coating.
Examiner further notes Hanai shows the reinforcement structure (Figs. 1, 3, and 4- metal wire 2A coated in resin coating film 2B forming linear member 2) embedded in the outer layer (Figs. 1, 3, and 4- outer polymeric elastomer layer 4) and thus bonded to inner layer tube (Figs. 1, 3, and 4- inner layer tube 1) by way of (via) the film coating (Figs. 1, 3, 4- resin coating film 2B).
Regarding Claim 2, Otake further teaches applying the reinforcement structure over the inner layer further comprises placing the inner layer into a braider [0060].
Hanai also teaches the reinforcement structure over the inner layer further comprises placing the inner layer into a braider [0061].
Regarding Claim 3, Otake further teaches applying the reinforcement structure over the inner layer further comprises placing the inner layer into a coil winder ([0047]- discussing the linear bodies being arranged into a spiral shape.
Hanai also teaches applying the reinforcement structure over the inner layer further comprises placing the inner layer into a coil winder [0114]-[0115].
Regarding Claim 4, Otake further teaches applying a removable heat shrink over the outer layer [0061].
Regarding Claim 5, Otake further teaches heating the removable (Fig. 2- heat shrinkable tube 15 is not present in the final product shown) heat shrink [0061]; and bonding, via the removable heat shrink, the outer layer, the reinforcement structure, and the inner layer together [0061].
Regarding Claim 6, Otake further teaches removing the removable heat shrink (Fig. 2- heat shrinkable tube 15 is not present in the final product shown and is thus necessarily removed).
Regarding Claim 7 and 14, Otake further teaches the reinforcement structure comprises a first portion and a second portion (Fig. 4- linear bodies 82), the method further comprising crossing the first portion over the second portion (Fig. 4- linear bodies 82 crossing; [0047]).
Regarding Claim 8 and 15, Otake further teaches bonding the first portion to the second portion ([0061]- the reinforcement member is embedded into the inner layer (thus bonding the first and second portion of the reinforcement structure)).
Regarding Claims 12 and 13, Otake further teaches coating the inner layer over a wire/mandrel prior to applying the reinforcement structure over the inner layer (Fig. 5- core wire 10 acting as a mandrel; [0059]- inner layer 6 extruded over core wire 10).
Regarding Claim 16, Otake teaches a method of manufacturing a reinforced catheter (Abstract), comprising:
applying a reinforcement structure (Fig. 2- reinforcement member 8) over an inner layer (Fig. 2- inner layer 6) such that the reinforcement structure at least partially encapsulates the inner layer (Fig. 2; [0037]),
wherein the reinforcement structure comprises a first portion and a second portion (Fig. 4- linear bodies 82);
crossing the first portion over the second portion such that the reinforcement structure creates a helical structure (Fig. 4- linear bodies 82 crossing; [0047]);
selectively bonding the first portion to the second portion ([0061]- the reinforcement member is embedded into the inner layer (thus bonding the first and second portion of the reinforcement structure));
applying an outer layer (Fig. 2- outer layer 7) over the reinforcement structure such that the outer layer encapsulates both the inner layer and reinforcement structure [0037].
Otake does not specify the reinforcement structure comprises a film coating.
Hanai teaches an alternative method of manufacturing a reinforced catheter (Abstract) wherein the reinforcement structure is coated in a film ([0079]- the metal wire 2A is dipped into a resin solution for forming the resin coating film 2B and the resin solution adhering to the metal wire 2A is then hardened may be employed) in order to reduce deformation of the body of the medical instrument (See Figs. 3 and 4) and avoid forming a hole or kink in the medical instrument [0089]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Otake to include a film-coated reinforcement structure as taught by Hanai with reasonable expectation of success to reduce deformation of the body of the medical instrument (See Figs. 3 and 4) and avoid forming a hole or kink in the medical instrument [0089].
The combination of the film-coated reinforcement structure of Hanai and the encapsulation steps of Otake taught above meets the instant limitations of bonding the reinforcement structure to i) the inner layer, ii) the outer layer, or iii) both, via a film coating.
Examiner further notes Hanai shows the reinforcement structure (Figs. 1, 3, and 4- metal wire 2A coated in resin coating film 2B forming linear member 2) embedded in the outer layer (Figs. 1, 3, and 4- outer polymeric elastomer layer 4) and thus bonded to inner layer tube (Figs. 1, 3, and 4- inner layer tube 1) by way of (via) the film coating (Figs. 1, 3, 4- resin coating film 2B).
Regarding Claims 17 and 18, Otake further teaches selectively bonding the first portion to the second portion comprises adhesively or chemically bonding the first portion to the second portion ([0061]- the reinforcement member is embedded into the inner layer (adhesively bonded to be embedded, chemically bonded after hardening)).
Regarding Claims 19 and 20, the combination of the film-coated reinforcement structure of Hanai and the encapsulation steps of Otake taught above meets the instant limitations of bonding, adhesively or chemically, the reinforcement structure to i) the inner layer, ii) the outer layer, or iii) both, via a film coating.
Examiner further notes Hanai shows the reinforcement structure (Figs. 1, 3, and 4- metal wire 2A coated in resin coating film 2B forming linear member 2) embedded in the outer layer (Figs. 1, 3, and 4- outer polymeric elastomer layer 4) and thus bonded to inner layer tube (Figs. 1, 3, and 4- inner layer tube 1) by way of (via) the film coating (Figs. 1, 3, 4- resin coating film 2B).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Otake et al (PGPub 2016/0136387 cited in IDS) in view of Hanai (PGPub 2019/0381216 with foreign priority to June 1, 2017) and Dinh et al (PGPub 2013/0253417).
Regarding Claim 10, Otake teaches extruding the inner layer over a core wire acting as a mandrel prior to applying the reinforcement structure over the inner layer [0059] and teaches other methods may be used to prepare the inner layer [0059] but does not specify stretching the inner layer prior to applying the reinforcement structure over the inner layer.
Dinh teaches an alternative method of making a catheter (Abstract) comprising stretching the inner layer over a mandrel prior to applying the reinforcement structure over the inner layer [0086] in order to size and position the liner before further processing [0086].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Otake and Hanai to include stretching the inner layer prior to applying the reinforcement structure as taught by Dinh with reasonable expectation of success to size and position the liner before further processing [0086] thus meeting the instant limitation of stretching the inner layer over a wire prior to applying the reinforcement structure over the inner layer.
Regarding Claim 11, Otake teaches extruding the inner layer over a core wire acting as a mandrel prior to applying the reinforcement structure over the inner layer [0059] and teaches other methods may be used to prepare the inner layer [0059] but does not specify stretching the inner layer over a mandrel prior to applying the reinforcement structure over the inner layer
Dinh teaches an alternative method of making a catheter (Abstract) comprising stretching the inner layer over a mandrel prior to applying the reinforcement structure over the inner layer [0086] in order to size and position the liner before further processing [0086].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Otake and Hanai to include stretching the inner layer prior to applying the reinforcement structure as taught by Dinh with reasonable expectation of success to size and position the liner before further processing [0086].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Adrianna Konves whose telephone number is (571)272-3958. The examiner can normally be reached Monday-Friday 8:00-4:00 MST (Arizona).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Abbas Rashid can be reached at (571) 270-7457. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.K./
Examiner, Art Unit 1748 8/12/26
/Abbas Rashid/Supervisory Patent Examiner, Art Unit 1748
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