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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/14/2026 has been entered.
Response to Arguments
Applicant's arguments filed 01/14/2026 have been fully considered but they are not persuasive.
Applicant argues that Bareau fails to teach or suggest a support wire, “wherein the support wire is configured to resist axial and longitudinal compression of the balloon” as required in claims 10, 21, and 29.
The examiner respectfully disagrees. First, the limitation “configured to resist axial and longitudinal compression of the balloon” is functional language. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the support wire is capable of doing. Since Bareau includes all of the structure required for the limitation (i.e. a support wire 18 disposed within a working lumen of an elongated member and extending distally from a distal end of the elongate member (claims 10 and 29)/a support wire 18 disposed within an inflation lumen and extending distally from a distal end of a catheter body (claim 21) (Figs. 1-3, para. 0046, 0054, 0069)) to necessitate the functional language, Bareau also meets the functional limitation of the claim. Furthermore, Bareau teaches that the claimed support wire (interpreted as core wire 18) provides rigidity to the device during insertion which is an action that requires axial and longitudinal movement (para. 0046). Therefore, the support wire of Bareau is capable of resisting axial and longitudinal compression of the balloon since it is designed to provide rigidity in the longitudinal direction. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues that Bareau fails to teach that the cylindrical region comprises the majority of the longitudinal length of the balloon when in its discrete predefined diameters. Applicant explains that Bareau does not explicitly state that the balloon comprises a cylindrical region along its longitudinal length or that the shape is maintained during inflation. Rather Bareau is focused on placement of the balloon catheter and maintaining it in a centered position.
The examiner respectfully disagrees. As shown in annotated Fig. 1 of Bareau below in the action, Bareau illustrates the balloon in its fully expanded state having a cylindrical region comprising a majority of a longitudinal length of the balloon (para. 0069 of Bareau). Para. 0069 of Bareau states that in the fully expanded state, the balloon is at a centered position and the ability to inflate to three specific diameters helps maintain the balloon about the center point of the anatomical region of interest. Therefore, Bareau does teach that the shape is maintained during inflation such that at each specific diameter, the center point, and thereby the cylindrical region, remains constant when expanded to each predefined discrete diameters. Therefore, the rejection is maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10, 12-18 and 29-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 10 and 29 recite the limitation “the elongate member comprising a support wire disposed within the working lumen and extending distally from a distal end of the elongate member”. The claim reads as though the elongated member, which in the specification can be an endoscope, comprises or includes the support wire. However, para. 0027-0028 of the instant application states “The balloon catheter assembly 170 further comprises a support wire 158…the support wire 158 is at least partially disposed within the lumen 111 of the catheter body 110”. Therefore, the written description has support for the balloon dilation catheter comprising the support wire but does not have support for the elongate member comprising the support wire as claimed. For examination purposes, the limitation is interpreted as “the elongate member comprising 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”.
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 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 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. 0021-0022, 0053-0054, 0089; Note: Figure 2 of Schaeffer illustrates the balloon 20 comprising an elongate region in between proximal and distal tapered regions of the balloon (see annotated Fig. 2 below). Since the balloon is spherical in shape, the elongate region of the balloon would form a cylindrical region that is designed to expand to at least four distinct diameters (para. 0054, 0086-0089);
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, 0083, 0087-0089);
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 untila 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, 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 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).
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Annotated Fig. 2 of Schaeffer
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Annotated Fig. 4 of Schaeffer
However, Schaeffer fails to disclose inserting the balloon dilation catheter through a working lumen of an elongate member into the strictured body lumen.
Bareau in the same field of endeavor teaches a method of positioning a balloon dilation catheter 10 within the GI tract (para. 0053), comprising inserting the balloon dilation catheter 10 through a working lumen of an elongate member (endoscope) into a strictured body lumen (para. 0053-0054) for the purpose of providing reliable visual verification of balloon positioning at a region of interest (para. 0053);
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 device in Schaeffer to include the endoscope of Bareau in order to allow the user to position the balloon at the target site effectively before the procedure (para. 0053).
However, modified Schaeffer in view of Bareau 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).
However, modified Schaeffer in view of Bareau fails to disclose wherein the elongate member comprises a support wire disposed within the working lumen and extending distally from a distal end of the elongate member, the support wire configured to resist axial and longitudinal compression of the balloon.
Bareau further discloses an elongate member (interpreted as an endoscope, para. 0054) comprising a support wire 18, by way of the balloon dilation catheter 10, disposed within a working lumen of the elongate member (Figs. 1-3, para. 0054, 0069) and extending distally from a distal end of the elongate member (Figs. 1-3, 0054, para. 0069), the support wire 18 configured to resist axial and longitudinal compression of the balloon (para. 0046).
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 catheter body in modified Schaeffer to include the support wire of Bareau in order to increase rigidity of the balloon, thereby preventing kinking during insertion of the balloon catheter (para. 0046 of Bareau).
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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 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 the proximal and distal ends of the balloon, wherein the cylindrical region of the balloon is configured to be expanded to four or more predefined discrete diameters correlated to four or more predefined discrete pressures; (see annotated Fig. 2 above). Since the balloon is spherical in shape, the elongate region of the balloon would form a cylindrical region that is designed to expand to at least four distinct diameters (para. 0054, 0086-0089));
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).
However, Schaeffer 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 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).
However, modified Schaeffer in view of Bareau fails to disclose wherein the elongate member comprises a support wire disposed within the working lumen and extending distally from a distal end of the elongate member, the support wire configured to resist axial and longitudinal compression of the balloon.
Bareau further discloses an elongate member comprising a support wire 18 disposed within a working lumen of the elongate member (see annotated Fig. 1 [a] above, Figs. 2-3, para. 0069) and extending distally from a distal end of the elongate member (Figs. 1-3, para. 0069), the support wire 18 configured to resist axial and longitudinal compression of the balloon (para. 0044-0046).
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 elongate member in modified Schaeffer to include the support wire of Bareau in order to increase rigidity of the balloon and the elongated member; thereby preventing kinking during insertion of the balloon catheter (para. 0046 of Bareau).
However, modified Schaeffer in view of Bareau fails to disclose wherein the catheter body comprises a support wire disposed within the working lumen and extending distally from a distal end of the elongate member, the support wire configured to resist axial and longitudinal compression of the balloon.
Bareau further discloses a catheter body comprising a support wire 18 disposed within an inflation lumen (see annotated Fig. 1 [a] below, Figs. 2-3, para. 0069) and extending distally from a distal end of the catheter body (Figs. 1-3, para. 0069), the support wire 18 configured to resist axial and longitudinal compression of the balloon (para. 0046).
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 catheter body in modified Schaeffer to include the support wire of Bareau in order to increase rigidity of the balloon, thereby preventing kinking during insertion of the balloon catheter (para. 0046 of Bareau).
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Annotated Fig. 1[a] 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 18 comprises radiopaque markers 11 disposed between the proximal end and the distal end of the balloon 19 (para. 0038 and 0079 of Bareau).
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
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.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771