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
The amendment filed January 15, 2026 has been entered. Claims 1-14, 16-18 and 20-21 are currently pending. Claims 12-14, 16-18, and 20 have been withdrawn from consideration.
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.
Claim(s) 1-11 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsutsui et al. (US 2015/0217093, hereinafter “Tsutsui”) in view of Durcan (US 6,200,325, hereinafter “Durcan”), Yamaguchi (US 2010/0174235, hereinafter “Yamaguchi”), Poker et al. (US 2016/0058983, hereinafter “Poker”), and Ha (US 2016/0045719).
Regarding claim 1, Tsutsui discloses the invention substantially as claimed including a method of manufacturing a device for performing a balloon dilation procedure at the site of a stenosis within a patient (abstract) and fully capable of being used within an airway of a patient, comprising:
providing a single lumen catheter (100) having a proximal end and a distal end; forming a balloon (10) from nylon (para [0026]) having a recommended inflation pressure (para [0024, 0033]), the balloon having a central portion (waist 30) positioned between proximal and distal hubbed ends (shoulders 23) and configured to allow the proximal and distal hubbed ends (23) to inflate before the central portion (30) of the balloon fully inflates, wherein the central portion (30) maintains a substantially linear profile when the balloon is inflated to the initial pressure and the balloon is unobstructed (para [0024, 0029]; Fig 1A);
stretching the proximal and distal hubbed ends of the balloon to a maximum expansion limit during the forming process, while the central portion is prevented from correspondingly stretching to the maximum expansion limit during the forming process (para [0022] – “The word "extend" means that a heated plastic film is stretched to align molecules thereof.” Para [0014, 0027] – shoulder parts are extended (or stretched) sufficiently, i.e. close to the limit of the extension ratio of the raw material, and the waist part is extended (or stretched) insufficiently to shape the balloon);
and coupling the balloon to the distal end of the catheter ([0028]).
Tsutsui fails to disclose the balloon is a high pressure balloon having an average rated burst pressure of between about 15 and about 27 atm and wherein the initial pressure the balloon is inflated to when the hubbed ends inflate before the central portion of the balloon fully inflates is between about 1 and 6 atm and the use inflation pressure is between 6 and 8 atmospheres less than the average rated burst pressure. Durcan discloses a similar balloon catheter with proximal and distal ends (37, 38) that expand at a first lower pressure and subsequently the central portion (30) expands at a second higher pressure (col 6, ln 25-32). Durcan teaches the balloon has a rated burst pressure of about 16 atm and that the proximal and distal hubbed ends (37, 38) expand at a first lower pressure of about 1-3 atm and the remainder of the balloon expands at a use inflation pressure of between 6 and 8 atmospheres less than the average rated burst pressure, i.e. the second higher pressure (col 6, ln 15-32 -- i.e. if the rated burst pressure is 16 atm and the use pressure, or second pressure, is between 4-10 atm, then the use pressure is between 6 and 12 atm less than the average rated burst pressure, which encompasses the claimed range). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tsutsui to have the claimed pressure values such that the balloon was formed as a high pressure balloon with an average rated burst pressure of between about 15 and about 27 atm, wherein a use inflation pressure was between 6 and 8 atmospheres less than the average rated burst pressure, and wherein the initial pressure the balloon is inflated to when the hubbed ends inflate before the central portion of the balloon fully inflates is between about 1 and 6 atm, as taught by Durcan, such that the balloon may be useful in other methods for use in other areas of the body requiring different dilation pressures. Furthermore, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Tsutsui fails to explicitly disclose the balloon is formed from a semi-compliant shape memory material, as claimed. However, Tsutsui does teach the balloon may be formed of nylon (para [0026]), which Applicant states is an example of a semi-compliant material (see published application para [0041]) and teaches a method of manufacture includes extruding the material in a manner that the hub-like portions of the balloon are memory shaped into the structure – i.e. after manufacture, inflation of the balloon to the preset pressure will produce a preset shape – lower pressure Fig 1A and higher pressure Fig 1B (para [0027,0029, 0033]). Therefore, it is obvious that balloon of Tsutsui is formed from a semi-compliant shape memory material, as claimed.
Tsutsui fails to specifically teach the step of stretching the proximal and distal hubbed ends of the balloon to a maximum expansion limit is performed during a blow molding step of the forming process. As discussed above, Tsutsui teaches “The word "extend" means that a heated plastic film is stretched to align molecules thereof” (para [0022]). And further teaches shoulder parts are extended (or stretched) sufficiently when the material is shaped, i.e. close to the limit of the extension ratio of the raw material, and the waist part is extended (or stretched) insufficiently when the material is shaped (para [0014, 0027]). “In an example of a method for producing the balloon 20, a plastic tube is formed by extrusion, and this tube is heated and then extended and shaped to spread only the shoulder parts 23” (para [0027]). Yamaguchi discloses a similar method of manufacturing a balloon catheter and teaches “The balloon is produced, for example, by dip molding or blow molding, and a suitable method is selected according to application. In the case of a balloon catheter for vasodilation of the stricture site of cardiac coronary, use of blow molding is preferable for sufficient pressure resistance. One example of method of preparing a balloon by blow molding will be described below. First, a tubular parison in arbitrary dimension is formed for example by extrusion molding. The tubular parison is placed in a metal mold having a shape corresponding to the balloon shape, forming a balloon having the shape identical with that of the mold by stretching it in the axial and diameter directions by biaxial stretching step. The biaxially stretching step may be carried out under heated condition for multiple times. The stretching in the axial direction may be preformed simultaneously with or before or after stretching in the diameter direction. The balloon may be annealed additionally for stabilization of its shape and dimension.” (para [0092]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the step of stretching the proximal and distal hubbed ends of the balloon to a maximum expansion limit of Tsutsui is performed during a blow molding step of the forming process since blow molding is old and well known in the art and since Yamaguchi teaches steps of blow molding include extruding a plastic tube and heating and extending the tube as desired while shaping the material, similar to Tsutsui.
Furthermore, Tsutsui fails to teach covering the balloon with a protective sheath. Poker discloses a protective sheath (2) with an additional secondary outer sleeve for a balloon catheter and teaches the secondary outer sleeve protects the sheath (2) during packaging and shipping (para [0042]) and the sheath protects the balloon and holds the balloon in the low-profile configuration for delivery (para [0045]). Therefore, 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 such that the balloon was covered with a protective sheath to protect the device during packaging and shipping and/or to protect the balloon and hold the balloon in the low-profile configuration during delivery, as taught by Poker.
Finally, Tsutsui fails to disclose providing a stylet sized to positioned within the single lumen catheter and configured to be positioned within the single lumen catheter to facilitate advancement of the high pressure balloon to a desired location within the patient. Ha discloses a similar balloon catheter (Fig 1) and teaches providing a stylet (22) made of relatively rigid material such that the balloon catheter at least partially conforms to the shape of the stylet and the stylet is used to advance the balloon catheter (para [0031,0039-0042]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tsutsui to provide a stylet as claimed to provide improved pushability and help guide the balloon catheter during delivery.
Regarding claims 2 and 8, Tsutsui fails to disclose coupling radiopaque markers to the single lumen catheter or coupling indicia to the high pressure balloon, the indicia being viewable with an endoscope or a fluoroscope. Durcan discloses a similar balloon catheter, as discussed above, and further teaches coupling radiopaque markers (43) to the catheter (col 7, ln 26-29). Therefore, 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 Tsutsui such that radiopaque markers were coupled to the catheter or balloon for the purpose of visualizing the catheter and balloon during the procedure to ensure correct placement.
Regarding claim 3, further wherein the central portion of the high pressure balloon is formed to have a first wall thickness that is greater than a second wall thickness of the distal and proximal ends (para [0027]).
Regarding claims 4-7 and 10-11, as discussed above, Durcan teaches a balloon with a rated burst pressure of about 16 atm and that the proximal and distal hubbed ends (37, 38) expand at a first lower pressure of about 1-3 atm (col 6, ln 15-32). Durcan additionally teaches “The deployment range is the inflation pressure at which the balloon working section is intended to be expanded within the patient to expand and deploy the stent. Below the deployment range, the inflation pressure is insufficient to expand the working length of the balloon and stent thereon. Above the deployment range, the balloon may rupture as the pressure approaches the burst pressure of the balloon” (col 2, Il 25-28). Furthermore, Durcan teaches “In a presently preferred embodiment, the balloon is preformed in a mold, so that the working length, tapered sections, and retention sections of the balloon have predictable inflated outer diameters which form when the balloon is inflated within a deployment range of the balloon” (col 3, 1114-18).
Thus, Durcan shows inflation pressure and diameter of the balloon are result effective variables. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Tsutsui, Durcan, and Poker such that the balloon was formed to have a diameter of between 5-10mm when filled with a fluid to a pressure of about 14-19 atm or 17 atm, or to modify the combination such that the balloon was formed to have a diameter of between 12-16 mm when filled with a fluid to a pressure of about 8-12 atm or 10 atm, or to modify the combination such that the balloon was formed to have a diameter of between 12-16 mm and a working length of about 40 mm, or to modify the combination to have a diameter of between about 5-10 mm and a working length of about 30 mm, for the purpose of optimizing the inflation characteristics of a balloon for a particular area of the body and sizing the balloon for a particular area of the body, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 9, Tsutsui fails to disclose the claimed length of the catheter, but teaches it is sized to allow insertion and advancement of the balloon from outside of the body to an area within the target area of the body (para [0030-0031]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Tsutsui, Durcan, and Poker such that the catheter was cut to a length of about 53-55 cm for the purpose of optimizing the length the catheter is inserted into a particular area of the body and minimize the length of the catheter outside of the body that may be tangled by a user, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 21, Tsutsui teaches the semi-compliant shape memory material used to fabricate the balloon is a polyamide (nylon is a type of polyamide - para [0026]).
Response to Arguments
Applicant’s arguments, see amendment, filed January 15, 2026, with respect to the rejection(s) of claim(s) 1-11 and 21 under 35 U.S.C. 103 as being unpatentable over Tsutsui (US 2015/0217093), Durcan (US 6,200,325), Yamaguchi (US 2010/0174235), and Poker (US 2016/0058983) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ha (US 2016/0045719).
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.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771