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, see page 5, filed 06/09/2026, with respect to the rejection(s) of claim(s) 10, 21, and 29 under a 103 rejection over Schaefer in view of Bareau have been fully considered and are persuasive. The examiner agrees that Bareau fails to teach the support wire is “operatively coupled to a hub of the balloon catheter assembly” as required in claims 10, 21, and 29. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in over Schaeffer (US 20140336617) in view of Hopkinson et al. (US 20150032086) and Bareau et al. (US 20170043142).
Regarding applicant’s arguments in relation to the support wire “being coupled to a distal end of the balloon”. The claim does not require a direct connection between the support wire and the distal end of the balloon such that it is in direct connection with wall of the balloon as discussed by the applicant. The claim only requires that the support wire is “coupled” to the distal end of the balloon. Language such as “connected to”, “coupled to” or “attached to” does not mean “directly” connected, coupled, or attached but indicates that two things can be “linked to” each other by way of their common connection to something else. This is supported by the instant application’s specification (see para. 0018: “The phrases "connected to," "coupled to," and "in communication with" refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to each other even though they are not in direct contact with each other”).
Claim Rejections - 35 USC § 103
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.
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) 10, 12-18, 21-22, 25-31 are rejected under 35 U.S.C. 103 as being unpatentable over Schaeffer (US 20140336617) in view of and Hopkinson et al. (US 20150032086) [hereinafter Hopkinson] in view of Bareau et al. (US 20170043142) [hereinafter Bareau].
Regarding claims 10 and 29, Schaeffer discloses a method of dilating a stricture of a body lumen (para. 0020, 0023, 0083), comprising:
obtaining a balloon catheter assembly 10 (Fig. 1, para. 0021) comprising
a balloon dilation catheter 12 comprising a balloon 20 expandable to four or more predefined discrete diameters of a cylindrical region of the balloon at four or more predefined discrete pressures (Figs. 1-2, para. 0022, 0054, 0089; Note: Figure 2 of Schaeffer illustrates the balloon 20 comprising an elongate region in between proximal and distal tapered regions of the balloon which is interpreted as the cylindrical region (see annotated Fig. 2 below));
inserting the balloon dilation catheter into the strictured body lumen (para. 0085);
referencing a label 104, 106 comprising first, second, third, and fourth predefined discrete balloon diameters correlated with first, second, third, and fourth predefined discrete pressures (Figs. 4-5, para. 0053-0054, 0088);
expanding the cylindrical region of the balloon to the first predefined discrete diameter by actuating a balloon inflation device 14 coupled to the balloon dilation catheter 12 until a first pressure unit indicia (interpreted as the first tick mark after the tick mark indicating zero pressure, see annotated Fig. 4 below; Note: the claim does not require a numerical unit of pressure on the pressure gauge, just an indicator of a first pressure unit) on a pressure gauge 16 of the balloon inflation device 14 (Fig. 4, para. 0049) indicates the first predefined discrete pressure is present in the balloon (Figs. 1-2, para. 0054, 0086-0089),
expanding the cylindrical region of the balloon to the second predefined discrete diameter at least one millimeter greater than the first predefined discrete diameter (see Fig. 4 of Schaeffer which illustrates the diameter indicia increasing by one millimeter, para. 0083) by actuating the balloon inflation device 14 until a second pressure unit indicia (interpreted as the second tick mark after the first tick mark indicating the first predefined pressure, see annotated Fig. 4 below; Note: the claim does not require a numerical unit of pressure on the pressure gauge, just an indicator of a second pressure unit) on the pressure gauge 16 of the balloon inflation device 14 (Fig. 4, para. 0049) indicates the second predefined discrete pressure (para. 0054 ,0086-0089) and
expanding the cylindrical region of the balloon to the third predefined discrete diameter at least one millimeter greater than the second predefined discrete diameter (see Fig. 4 of Schaeffer which illustrates the diameter indicia increasing by one millimeter, para. 0083) by actuating the balloon inflation device 14 until a third pressure unit indicia (interpreted as the third tick mark after the second tick mark indicating the second predefined pressure, see annotated Fig. 4 below; Note: the claim does not require a numerical unit of pressure on the pressure gauge, just an indicator of a third pressure unit) on the pressure gauge 16 of the balloon inflation device 14 (Fig. 4, para. 0049) indicates the third predefined discrete pressure (para. 0054, 0086-0089);
expanding the cylindrical region of the balloon to the fourth predefined discrete diameter at least one millimeter greater than the third predefined discrete diameter (see Fig. 4 of Schaeffer which illustrates the diameter indicia increasing by one millimeter; Note: Schaeffer further discloses in para. 0059 that the measuring device may include any suitable number of indicia, and specifically lists six indicia such that a user may expand to a fourth predefined diameter greater than the third predefined diameter) by actuating the balloon inflation device until a fourth pressure unit indicia (interpreted as a fourth tick mark after the third tick mark indicating the third predefined pressure; Note: the claim does not require a numerical unit of pressure on the pressure gauge, just an indicator of a fourth pressure unit) on the pressure gauge 16 of the balloon inflation device 14 (Fig. 4, para. 0049) indicates the fourth predefined discrete pressure (para. 0054, 0059, 0086-0089).
PNG
media_image1.png
234
264
media_image1.png
Greyscale
Annotated Fig. 2 of Schaeffer
Schaffer further discloses that the balloon dilation catheter can include “a camera disposed on the balloon catheter, or provided separately, are considered suitable methods of visualizing the position of a medical device within a bodily passage during a procedure” (see para. 0086 of Schaffer). The reference further discloses a hub 28 located at a proximal end of the balloon dilation catheter (Fig. 2, para. 0027: “Device lumen 32 extends from a first device lumen opening 38 defined on the device port 28 to a second device lumen opening 39 defined on the elongate member distal end 24”).
However, Schaeffer fails to disclose inserting the balloon dilation catheter through a working lumen of an elongate member into the strictured body lumen and wherein the elongate member comprises a support wire, by way of the balloon dilation catheter, disposed within the working lumen and extending distally from a distal end of the elongate member and being coupled to a distal end of the balloon, the support wire operatively coupled to a hub of the balloon catheter assembly to resist axial and longitudinal compression of the balloon.
Hopkinson in the same field of endeavor of balloon dilation catheters 100 (Fig. 2, para. 0024) teaches that it is known in the art to insert the balloon dilation catheter 100 through a working lumen (interpreted as delivery lumen described in para. 0025 below) of an elongated member (interpreted as endoscope described in para. 0025 below) into a body lumen, wherein the elongate member comprises a support wire 158, by way of the balloon dilation catheter 100 (see Fig. 2), disposed within the working lumen and extending distally from a distal end of the elongate member and being coupled to a distal end of a balloon 120 (see Fig. 2, para. 0025: “the support wire 158 extends longitudinally…into the inflation balloon 120, or the interior of the inflation balloon 120…the support wire 158 is configured to add increased rigidity and/or stiffness to the elongated member 110 and/or the inflation balloon 120, which may aid in insertion of the balloon catheter assembly 100 into a delivery lumen (e.g., an endoscope) and/or a body lumen during use by a practitioner”),
the support wire 158 operatively coupled to a hub 154 of the balloon catheter assembly 100 to resist axial and longitudinal compression of the balloon (para. 0025: “In some embodiments, the proximal end 160 of the support wire 158 may be operatively coupled to the hub 154…such that the support wire 158 transfers distally oriented forces exerted on the hub 154 but not proximally oriented forces exerted on the hub 154”; para. 0026: “the support wire 158 of the balloon catheter assembly 100 may be configured such that the inflation balloon 120 resists longitudinal compression upon insertion or passage of the inflation balloon 120 into or through a delivery lumen and/or a body lumen”).
In light of these teachings, 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 balloon dilation catheter in Schaeffer to include the endoscope and the support wire operatively coupled to the hub, as taught by Hopkinson since it is known in the art to utilize endoscopes for visualization purposes during the procedure, thereby providing a way for a user to visualize the positioning of the balloon at a target site (para. 0025 of Hopkinson: “insertion of the balloon catheter assembly 100 into a delivery lumen (e.g., an endoscope) and/or a body lumen during use by a practitioner”) and provide increased stiffness and rigidity to the catheter by way of the support wire to aid in insertion through the endoscope (para. 0025 of Hopkinson: “the support wire 158 is configured to add increased rigidity and/or stiffness to the elongated member 110 and/or the inflation balloon 120, which may aid in insertion of the balloon catheter assembly 100 into a delivery lumen (e.g., an endoscope)”).
However, modified Schaeffer in view of Hopkinson fails to disclose wherein the cylindrical region comprises a majority of a longitudinal length of the balloon when the cylindrical region is expanded to the first, second, third, and fourth predefined discrete diameters.
Bareau further teaches a dilation balloon 19 configured to expand to three predetermined diameters (Fig. 1, para. 0069) and including a cylindrical region comprising a majority of a longitudinal length of the balloon (see annotated Fig. 1 below) for the purpose of treating strictured body lumens (para. 0002, 0004, 0042).
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 length of the balloon in modified Schaeffer such that the cylindrical region comprises the majority of the longitudinal length of the balloon, as taught in Bareau, in order to provide improved dilation of a gastrointestinal tract (para. 0007, 0042).
PNG
media_image2.png
230
718
media_image2.png
Greyscale
Annotated Fig. 1 of Bareau
Regarding claim 12, modified Schaeffer discloses wherein the second predefined discrete pressure is greater than the first predefined discrete pressure, the third predefined discrete pressure is greater than the second predefined discrete pressure, and the fourth predefined discrete pressure is greater than the third predefined discrete pressure (para. 0054-0055 of Schaeffer).
Regarding claim 13, modified Schaeffer discloses the fourth predefined discrete diameter is equivalent to or less than a diameter of the non-strictured body lumen. (as noted above in the modification, the plurality of indicia may include up to six indicia before the burst/rupture region 106. The maximum diameter is the fifth predefined diameter, which is greater than the fourth predefined diameter. Schaeffer further discloses that region 104 indicates the maximum indicia before the balloon is overinflated which prevents damage to the body passage (para. 0003, 0054). Therefore, the fourth predefined discrete diameter is less than a diameter of the non-strictured body lumen.)
Regarding claim 14, modified Schaeffer discloses depressurizing the balloon; and removing the balloon dilation catheter from the working lumen of the elongated member (steps 312 and 314; para. 0083, para. 0090-0091 of Schaeffer).
Regarding claim 15, modified Schaeffer discloses further comprising referencing the label comprising a fifth predefined discrete balloon diameter correlated with a fifth predefined discrete pressure (Para. 0083, 0087-0089 of Schaeffer discloses the step of expanding the balloon and visualizing the plurality of indicia to indicate that the balloon reached a desired predetermined inflated balloon diameter).
Regarding claim 16, modified Schaeffer discloses further comprising expanding the cylindrical region of the balloon to the fifth predefined discrete diameter at least one millimeter greater than the first predefined discrete diameter at the fifth predefined discrete pressure (see Fig. 4 of Schaeffer which illustrates the diameter indicia increasing by one millimeter, para. 0083; Note: Schaeffer further discloses in para. 0059 that the measuring device may include any suitable number of indicia, and specifically lists six indicia such that a user may expand to a fifth predefined diameter greater than the first predefined diameter), wherein the cylindrical region comprises a majority of the longitudinal length of the balloon when the cylindrical region is expanded to the fifth predefined discrete diameter (as taught by Bareau, see annotated Fig. 1 of Bareau above, para. 0069 of Bareau).
Regarding claim 30, modified Schaeffer discloses wherein the cylindrical region of the balloon is expandable to diameters ranging from 1.0 mm to 25.0 mm (Figs. 4 and 4A of Schaeffer illustrates that the balloon is expandable to greater than 20 mm).
Regarding claim 21, Schaeffer discloses a method for inflating a balloon catheter, comprising:
obtaining a balloon catheter assembly 10 (Fig. 1, para. 0021) comprising
a catheter body 18 (Figs. 1-2, para. 0022) comprising:
an inflation lumen 30 extending along a portion of the catheter body 18 (Fig. 2, para. 0027);
a fluid connector (interpreted as the connector element proximal to measuring device 16, Fig. 1) coupled to the catheter body 18 adjacent a proximal end and in fluid communication with the inflation lumen 30 (para. 0030); and
a balloon 20 (Fig. 2) comprising a distal end 24, a proximal end 44, and a cylindrical region between the proximal end 44 and the distal end 24 ( Note: Figure 2 of Schaeffer illustrates the balloon 20 comprising an elongate region in between proximal and distal tapered regions of the balloon which is interpreted as the cylindrical region (see annotated Fig. 2 above));
referencing a label 104, 106 comprising first, second, third, and fourth predefined discrete balloon diameters correlated with first, second, third, and fourth predefined discrete pressures (Figs. 4-5, para. 0053-0054, 0083, 0087-0089);
expanding the cylindrical region of the balloon to a discrete diameter of the four or more predefined discrete diameters by actuating a balloon inflation device 14 coupled to the fluid connector (Figs. 1-2, para. 0037) until a pressure unit indicia (interpreted as the four or more tick marks on the measuring device 16; Note: the claim does not require a numerical unit of pressure on the pressure gauge, just an indicator of the pressure unit) on a pressure gauge 16 of the balloon inflation device 14 indicates a pressure of the four or more predefined pressures correlated to the discrete diameter of the four or more predefined discrete diameters is present within the balloon inflation device (Figs. 1-2, see annotated Fig. 4 above, para. 0054, 0049, 0059, 0086-0089).
The reference further discloses a hub 28 located at a proximal end of the balloon dilation catheter (Fig. 2, para. 0027: “Device lumen 32 extends from a first device lumen opening 38 defined on the device port 28 to a second device lumen opening 39 defined on the elongate member distal end 24”).
However, Schaeffer fails to disclose the catheter body comprising a support wire disposed within the inflation lumen and extending distally from a distal end of the catheter body and being coupled to a distal end of a balloon, wherein the support wire is operatively coupled to a hub of the balloon catheter assembly to resist axial and longitudinal compression of the balloon.
Hopkinson in the same field of endeavor of balloon dilation catheters 100 (Fig. 2, para. 0024) teaches that it is known in the art to include a support wire 158 disposed within an inflation lumen 111 and extending distally from a distal end of a catheter body 110 and being coupled to a distal end of a balloon 120 (see Fig. 2, para. 0023: “An interior of the inflation balloon 120 is in fluid communication with the lumen 111 of the elongated member 110 (i.e., the inflation/deflation lumen”; para. 0025: “ the support wire 158 extends longitudinally within the lumen 111 of the elongated member 110 and into the inflation balloon 120, or the interior of the inflation balloon 120.…the support wire 158 is configured to add increased rigidity and/or stiffness to the elongated member 110 and/or the inflation balloon 120, which may aid in insertion of the balloon catheter assembly 100 into a delivery lumen (e.g., an endoscope) and/or a body lumen during use by a practitioner”), the support wire 158 operatively coupled to a hub 154 of the balloon catheter assembly 100 to resist axial and longitudinal compression of the balloon (para. 0025: “In some embodiments, the proximal end 160 of the support wire 158 may be operatively coupled to the hub 154…such that the support wire 158 transfers distally oriented forces exerted on the hub 154 but not proximally oriented forces exerted on the hub 154”; para. 0026: “the support wire 158 of the balloon catheter assembly 100 may be configured such that the inflation balloon 120 resists longitudinal compression upon insertion or passage of the inflation balloon 120 into or through a delivery lumen and/or a body lumen”).
In light of these teachings, 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 balloon dilation catheter in Schaeffer to include the support wire operatively coupled to the hub, as taught by Hopkinson in order to provide increased stiffness and rigidity to the catheter by way of the support wire to aid in insertion through the endoscope (para. 0025 of Hopkinson: “the support wire 158 is configured to add increased rigidity and/or stiffness to the elongated member 110 and/or the inflation balloon 120, which may aid in insertion of the balloon catheter assembly 100 into a delivery lumen (e.g., an endoscope)”).
However, Schaeffer in view of Hopkinson fails to disclose wherein the cylindrical region comprises a majority of a longitudinal length of the balloon when the cylindrical region is expanded to each discrete diameter of the four or more predefined discrete diameters.
Bareau further teaches a dilation balloon 19 configured to expand to three predetermined diameters (Fig. 1, para. 0069) and including a cylindrical region comprising a majority of a longitudinal length of the balloon (see annotated Fig. 1 below) for the purpose of treating strictured body lumens (para. 0002, 0004, 0042).
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 shape of the balloon in modified Schaeffer such that the cylindrical region comprises the majority of the longitudinal length of the balloon, as taught in Bareau, in order to provide improved dilation of a gastrointestinal tract (para. 0007, 0042 of Bareau).
Regarding claim 22, modified Schaeffer discloses wherein the cylindrical region of the balloon is expandable to five predefined discrete diameters (para. 0054, 0055 of Schaeffer).
Regarding claims 25, Modified Schaeffer discloses wherein the support wire 158 comprises radiopaque markers 267 disposed between the proximal end and the distal end of the balloon (see Fig. 3A, para. 0038 of Hopkinson: “At least a portion of the support wire 258…may comprise one or more radiopaque markers 267”; para. 0031 of Hopkinson: “Any suitable combination of the features, and variations of the same, described with respect to the balloon catheter assembly and components illustrated in FIGS. 1 and 2 can be employed with the balloon catheter assembly and components of FIG. 3A, and vice versa”)).
Regarding claim 26, modified Schaeffer discloses wherein the balloon comprises one or more of nylon, polyether block amide, and polyurethane (para. 0029 of Schaeffer).
Regarding claim 27, modified Schaeffer discloses wherein the cylindrical region of the balloon is expandable to diameters ranging from 1.0 mm to 25.0 mm (Figs. 4 and 4A of Schaeffer illustrates that the balloon is expandable to greater than 20 mm).
Regarding claims 17-18, 28, and 31, modified Schaeffer discloses all of the limitations set forth above in claims 10, 16, 21, and 29. However, modified Schaeffer fails to disclose that the balloon is expandable at pressures ranging from one atmosphere to twelve atmospheres (claims 28 and 31), wherein the first predefined discrete pressure is at least one atmosphere (claim 17), and the fifth predefined discrete pressure is less than or equal to twelve atmospheres (claim 18).
Schaeffer discloses that the balloon dilation device 10 (Fig. 1 of Schaeffer) is used to dilate a variety of bodily passages such as a body vessel/vasculature, airway, sinus cavity, sinus passage, or GI tract, etc (para. 0003, 0047, 0101). With such a variety of uses, Schaeffer emphasizes the importance of determining the diameter of the balloon and measuring the pressure of the balloon during the procedure (para. 0049, 0054), to prevent damage to the bodily passage if overinflated or fail to provide the necessary dilation if underinflated (para. 0003).
In the instant case, the balloon of modified Schaeffer would not operate differently with the claimed pressure range since the balloon of Schaeffer is designed to dilate a stricture of a body lumen (para. 0020, 0023, 0083). Modifying the balloon of Schaeffer to be expandable at pressures ranging from one atmosphere to twelve atmospheres (claims 28 and 31), wherein the first predefined discrete pressure is at least one atmosphere (claim 17), and the fifth predefined discrete pressure is less than or equal to twelve atmospheres is a result effective variable in that changing the pressure of the balloon changes the diameter of the balloon which affects the amount of dilation provided in the body lumen being treated such that excessive dilation due to overinflation and deficient dilation due to under inflation does not occur. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Schaeffer balloon to have a pressure within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment (para. 0003, 0049, 0054 of Schaeffer). Applicant also appears to have placed no criticality on the claimed range (see para. 0024 of the instant application indicating the balloon “may” be expanded within the claimed range).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the balloon of Schaeffer to be expandable at pressures ranging from one atmosphere to twelve atmospheres (claims 28 and 31), wherein the first predefined discrete pressure is at least one atmosphere (claim 17), and the fifth predefined discrete pressure is less than or equal to twelve atmospheres, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
Prosecution Insights