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 Amendments
The amendment to 56 is acknowledged and the previous claim objection is withdrawn.
Response to Arguments
Applicant’s arguments, filed 07/08/2026, with respect to the rejection of claim(s) 28, 56, and 67 under Okada in view of Hallisey and Farhadi (US 20160081537) for the rejection of claim 28 have been considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejection of the claims has been withdrawn in light of said amendments. Specifically, the rejections were withdrawn because the combinations above do not teach an additional “lumen configured to deliver another fluid into the gastrointestinal tract. It is noted that a new rejection has been made over De Bruyne (US 20190290889) in view of Hallisey, and Farhadi for the rejection of claim 28, De Bruyne in view of Hallisey and Kiminami et al. (US 20130085519) for the rejection of claim 56, and De Bruyne in view of Hallisey and Bareau for the rejection of claim 67.
Claim Objections
Claims 28, 52, 56, 61, and 67 are objected to because of the following informalities:
Claims 28, 56, and 67 recite “at least two apertures, a first aperture…and a second aperture” in lines 10, although the lines do not rise to the level of being indefinite as the lines are understood by the Examiner to mean “at least two apertures comprising a first aperture …and a second aperture” as the first and second apertures are understood to be encompassed by the “at least two apertures” and not as two separate apertures in combination with the “at least two apertures, the Examiner suggests the lines be amended to read “at least two apertures comprising a first aperture …and a second aperture” for the purpose of maintaining consistent language throughout the claims;
Claim 28 recites “the fluid into the gastrointestinal track” in line 22, although the line does not rise to the level of being indefinite as the line is understood by the Examiner to mean “the another fluid” based on Applicant’s specification wherein the first aperture is configured to deliver the “another fluid”, the Examiner suggests the line be amended to read “the another fluid” for the purpose of maintaining consistent language throughout the claims;
Claims 52 and 61 recite “an inflation fluid” and “the inflation lumen” in lines 2, although the lines do not rise to the level of being indefinite as the lines are understood by the Examiner to mean “the fluid” as the “fluid” configured to inflate the flexible member was previously defined as “the fluid” in the respective independent claims, the Examiner suggests the lines be amended to read “the fluid” for the purpose of maintaining consistent language throughout the claims;
Claim 67 recites “a fluid” in line 7, although the phrase is understood by the Examiner to mean “another fluid” that is different from the at least one liquid or gas as previously defined, the Examiner suggests the line be amended to read “another fluid” to further differentiate the “at least one liquid or gas” and the “fluid”;
Claim 67 recites “a fluid comprising saline and contrast, the first aperture configured to deliver the fluid”, although the line does not rise to the level of being indefinite as the line is understood by the Examiner to mean “the another fluid comprising saline and contrast, the first aperture configured to deliver the another fluid” based on Applicant’s specification wherein the first aperture is configured to deliver the “another fluid comprised of saline and contrast”, the Examiner suggests the line be amended to read “the another fluid comprising saline and contrast, the first aperture configured to deliver the another fluid” for the purpose of maintaining consistent language throughout the claims;
Appropriate correction is required.
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.
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) 28, 50, 52-54, and 65 are rejected under 35 U.S.C. 103 as being unpatentable over De Bruyne (US 20190290889) in view of Hallisey et al. (US 20190298389) [hereinafter Hallisey] and Farhadi (US 20160081537).
Regarding claim 28, De Bruyne discloses a system configured to block at least a portion of a lumen of a gastrointestinal tract during an endoscopy procedure (Fig. 10, para. 0001: “The invention relates to an infusion catheter device designed to be able to be introduced into a conduit comprising at least one partial or total obstruction to be treated. In particular, the invention relates to an infusion catheter device which can be introduced into a channel of the body of an animal or human being, chosen from the group consisting of…the esophagus”), the system comprising:
a flow reducing device 110 (Fig. 5, para. 0123) comprising:
an infusion lumen 182 configured to receive a fluid (Fig. 6, para. 0152: “a third lumen 82, 182, 282, 382, communicating via an opening 84, 184, 284, 384 with the interior of the obstruction element, here a balloon 72, 172, 272, 372, which can be deflated to a rest position or inflated from this rest position to an inflated working position”);
a guidewire lumen 128 configured for a guidewire 130 to pass therethrough (Figs. 6-7, para. 0150 (para. 0150: “a first lateral channel 128, called monorail, defining a first lateral lumen, shown in FIGS. 5 to 10, which allows the catheter to be advanced on any guidewire 30, 130”);
wherein at least a portion of the guidewire lumen 128 is parallel to the infusion lumen 182 (see Figs. 6-7);
a lumen 114 configured to deliver another fluid into the gastrointestinal tract (Fig. 6 para. 0001: “the invention relates to an infusion catheter device which can be introduced into a channel of the body of an animal or human being, chosen from the group consisting of…the esophagus” and para. 0125: “the second channel 114 is closed at its distal end by a leak tight partition 114c in order to force the infusion liquid to pass through the infusion orifices 116”);
an elongate body 112 having a proximal end and a distal end and defining the infusion lumen 182, the guidewire lumen 128, and the lumen 114 therethrough (see Fig. 6), the elongate body further comprising a flexible member 170 (Fig. 6, para. 0123: “the sealing element 170, such as a balloon 172”) and defining at least two apertures 116, 184, a first aperture (interpreted as one of the plurality of infusion orifices 116) positioned distally on the elongate body 112 relative to the flexible member 170 (see Fig. 6, para. 0125) and a second aperture 184 positioned within the flexible member 170, the second aperture 184 being configured to inflate the flexible member (see Fig. 6, para. 0152);
wherein the second aperture 184 is in communication with the infusion lumen 182 (see Fig. 6);
wherein at least a portion of the elongate body 112 extends through an entirety of a length of the flexible member 170 (see Figs. 6);
wherein the flexible member 170 is coupled to a proximal position of the elongate body 112 (interpreted as the proximal end of the flexible member coupled to a proximal portion of the elongate body, see Fig. 6) and a distal position of the elongate body (interpreted as the distal end of the flexible member coupled to a proximal portion of the elongate body, see Fig. 6);
wherein the flexible member 170 is inflatable to an expanded configuration from an unexpanded configuration when the fluid flows through the infusion lumen 182 of the elongate body 112 and out the second aperture 184 of the elongate body 112 (para. 0152); and
wherein the first aperture 116 is in communication with the lumen 114 and is configured to deliver the fluid into the gastrointestinal tract (para. 0125).
De Bruyne is silent regarding a first aperture positioned proximally on the elongate body relative to the flexible member.
Hallisey in the same field of endeavor of occlusion balloon catheters (para. 0033, 0035) teaches that it is known in the art to for an elongate body 210 to have a first aperture 215 positioned proximally on the elongate body 210 relative to a flexible member 250 (Fig. 4A, para. 0033) for the purpose of delivering fluid upstream from the occlusion to a body lumen (Fig. 4A, para. 0033).
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 body in De Bruyne to position an additional aperture proximally on the elongated body relative to the flexible member, as taught by Hallisey, in order to provide a way for the elongate body of De Bruyne to deliver infusion liquid upstream from the occlusion (para. 0033 of Hallisey), thereby protecting material or tissues proximal of the occlusion during the procedure, as desired by De Bruyne (para. 0045 of De Bruyne: “the infusion liquid is a liquid brought to a temperature protecting the material or tissues of the wall of the conduit. This temperature can be a temperature that is sufficiently cold to hibernate the tissues of the channel to be protected during a predetermined period of time”).
However, the combination of De Bruyne and Hallisey fails to disclose an echoendoscope.
Farhadi in the same field of endeavor of occlusion devices used within the gastrointestinal tract (Fig. 1, para. 0050) teaches that it is known in the art to use an echoendoscope for the purpose of allowing a user to image at least a portion of a gastrointestinal tract during the procedure (para. 0003: “An echoendoscope (EUS) is a device that combines endoscopy and ultrasound to image the gastrointestinal wall and surrounding structures.”, para. 0050).
In light of this teaching, 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 occlusion device in modified De Bruyne to include the echoendoscope of Farhadi in order to allow the user to have a real time image of the gastrointestinal wall and its surrounding structures during the procedure (para. 0003: “The reflection of these ultrasound waves will be detected by the same crystals at the transducer and reconstruction of these reflections will result in creating a real time image of the gastrointestinal wall and its surrounding structures” – Farhadi).
Regarding claim 50, as discussed above, it would have been obvious to modify the system De Bruyne in view of Hallisey and Farhadi. Additionally, De Bruyne discloses that “The inflation and deflation of the balloon, for example situated between one and several centimeters or several millimeters upstream from the distal lateral infusion orifices” in para. 0153 of De Bruyne”.
However, the combination of De Bruyne in view of Hallisey and Farhadi is silent regarding wherein the flexible member is about 0.1 inches to about 5 inches from the distal end of the elongate body.
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 distance between the flexible member and the distal end of the elongated body of modified De Bruyne such that the flexible member is about 0.1 inches to about 5 inches from the distal end of the elongate body since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
In the instant case, the distance between the flexible member and the distal end of the elongate body of modified De Bruyne would not operate differently with the claimed distance range and since the flexible member is intended to be distanced from the distal end of the elongate body (see Fig. 6 of De Bruyne and para. 0153 of De Bruyne). Therefore, having the distance between the flexible member and the distal end of the elongated body of modified De Bruyne such that the flexible member is about 0.1 inches to about 5 inches from the distal end of the elongate body would function appropriately having the claimed angle.
Further, it appears that applicant places no criticality on the distance claimed, indicating simply that “In some embodiments, the flexible member 1214 is about 0.1 inches to about 5 inches from the distal end of the inner shaft 1210. In some embodiments, the flexible member 1214 is about 0.8 inches to about 1.2 inches from the distal end, shown as cap 1224, of the inner shaft 1210.” (para. 00127 of the instant application). Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Regarding claim 52, as discussed above, it would have been obvious to modify the system De Bruyne in view of Hallisey and Farhadi. Additionally, De Bruyne discloses wherein the flexible member 170 is configured to retain an inflation fluid when the inflation fluid flows out of the second aperture 184 of the elongate body 112 to configure the flexible member 170 in the expanded configuration (Fig. 7, para. 0152 of De Bruyne: “a third lumen 82, 182, 282, 382, communicating via an opening 84, 184, 284, 384 with the interior of the obstruction element, here a balloon 72, 172, 272, 372, which can be deflated to a rest position or inflated from this rest position to an inflated working position”).
Regarding claims 53-54, as discussed above, it would have been obvious to modify the system De Bruyne in view of Hallisey and Farhadi. Additionally, De Bruyne disclose wherein the elongate body comprises a distal tip 112c disposed at the distal end of the elongate body (see Fig. 6 of De Bruyne; The examiner notes that the distal tip 112c is discussed in para. 0125 of De Bruyne as “a leaktight partition 114c” which correlates the distal tip of the embodiment of Figs. 1-4, “leaktight partition 12c” in para. 0109) and the guidewire lumen 128 includes a distal end comprising a distal opening extending out of the distal end of the distal tip 112c in which the guidewire 130 extends therethrough (Fig. 6, para. 0150).
However, the combination above is silent regarding (i) [claim 53] wherein the distal tip comprises a valve configured to prevent the liquid from exiting the distal tip of the elongate body and (ii) [claim 54] further comprising a cap connected to the distal tip of the elongate body, the cap defining a bore therethrough such that an elongate device can be passed through the elongate body and out the bore defined by the cap.
Hallisey further teaches wherein the elongate body 210 can further comprise a distal tip 230 disposed at the distal end of the elongate body 210 (Fig. 4A, para. 0034 of Hallisey), wherein the distal tip 230 comprises a valve 236 configured to prevent the liquid from exiting the distal tip 230 of the elongate body (Fig. 4A, para. 0034) and a cap 235 connected to the distal tip 230 of the elongate body (Fig. 4A, para. 0034), the cap 235 defining a bore (interpreted as distal opening defined by cap 235, see Fig. 4A) therethrough such that a guidewire can be passed through the elongate body and out the bore defined by the cap without losing infusion liquid flowing through a lumen 213 of the elongated body (Fig. 4A, para. 0034 of Hallisey).
In light of this teaching, 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 closed distal tip comprising the distal opening of the guidewire lumen in modified De Bruyne to have the valve and the cap comprising the bore, as taught by Hallisey, such that the distal end of the guidewire lumen of modified De Bruyne would end at the valve of Hallisey and the guidewire of modified De Bruyne would extend through the valve and the bore provided by the cap of Hallisey. Such a modification would provide an alternative way to prevent infusion liquid from exiting the distal tip as discussed in Hallisey (para. 0034 of Hallisey) and desired in De Bruyne (para. 0125 of De Bruyne), but also prevent particles from destroying an obstruction from entering the distal end of the guidewire lumen (see Fig. 10, para. 0158 of De Bruyne: “This guidewire is advanced into the distal part of the artery, through the occlusion responsible for the infarct”).
Regarding claim 65, as discussed above, it would have been obvious to modify the system De Bruyne in view of Hallisey and Farhadi. Additionally, De Bruyne disclose wherein the fluid is gas (para. 0111 of De Bruyne: “the balloon inflation fluid, for example a gas such as air, or a liquid, may comprise an undiluted contrast agent”).
Claim(s) 56, 59, 61-63, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over De Bruyne (US 20190290889) in view of Hallisey et al. (US 20190298389) [hereinafter Hallisey] and Kiminami et al. (US 20130085519) [hereinafter Kiminami].
Regarding claim 56, De Bruyne discloses a system configured to block at least a portion of a lumen of a gastrointestinal tract during an endoscopy procedure (Fig. 10, para. 0001: “The invention relates to an infusion catheter device designed to be able to be introduced into a conduit comprising at least one partial or total obstruction to be treated. In particular, the invention relates to an infusion catheter device which can be introduced into a channel of the body of an animal or human being, chosen from the group consisting of…the esophagus”), the system comprising:
a flow reducing device 110 (Fig. 5, para. 0123) comprising:
an infusion lumen 182 configured to receive a fluid (Fig. 6, para. 0152: “a third lumen 82, 182, 282, 382, communicating via an opening 84, 184, 284, 384 with the interior of the obstruction element, here a balloon 72, 172, 272, 372, which can be deflated to a rest position or inflated from this rest position to an inflated working position”);
a guidewire lumen 128 configured for a guidewire 130 to pass therethrough (Figs. 6-7, para. 0150 (para. 0150: “a first lateral channel 128, called monorail, defining a first lateral lumen, shown in FIGS. 5 to 10, which allows the catheter to be advanced on any guidewire 30, 130”);
wherein at least a portion of the guidewire lumen 128 is parallel to the infusion lumen 182 (see Figs. 6-7);
a lumen 114 configured to deliver another fluid into the gastrointestinal tract (Fig. 6 para. 0001: “the invention relates to an infusion catheter device which can be introduced into a channel of the body of an animal or human being, chosen from the group consisting of…the esophagus” and para. 0125: “the second channel 114 is closed at its distal end by a leaktight partition 114c in order to force the infusion liquid to pass through the infusion orifices 116”);
an elongate body 112 having a proximal end and a distal end and defining the infusion lumen 182, the guidewire lumen 128, and the lumen 114 therethrough (see Fig. 6), the elongate body further comprising a flexible member 170 (Fig. 6, para. 0123: “the sealing element 170, such as a balloon 172”) and defining two or more apertures 116, 184, a first aperture (interpreted as one of the plurality of infusion orifices 116) positioned distally on the elongate body 112 relative to the flexible member 170 (see Fig. 6, para. 0125) and a second aperture 184 positioned within the flexible member 170, the second aperture 184 being configured to inflate the flexible member (see Fig. 6, para. 0152);
wherein the second aperture 184 is in communication with the infusion lumen 182 (see Fig. 6);
wherein at least a portion of the elongate body 112 extends through an entirety of a length of the flexible member 170 (see Figs. 6);
wherein the flexible member 170 is coupled to a proximal position of the elongate body 112 (interpreted as the proximal end of the flexible member coupled to a proximal portion of the elongate body, see Fig. 6) and a distal position of the elongate body (interpreted as the distal end of the flexible member coupled to a proximal portion of the elongate body, see Fig. 6);
wherein the flexible member 170 is inflatable to an expanded configuration from an unexpanded configuration when the fluid flows through the infusion lumen 182 of the elongate body 112 and out the second aperture 184 of the elongate body 112 (para. 0152); and
wherein the first aperture 116 is in communication with the lumen 114 (para. 0125).
However, De Bruyne fails to disclose a first aperture positioned proximally on the elongate body relative to the flexible member.
Hallisey in the same field of endeavor of occlusion balloon catheters (para. 0033, 0035) teaches that it is known in the art to for an elongate body 210 to have a first aperture 215 positioned proximally on the elongate body 210 relative to a flexible member 250 (Fig. 4A, para. 0033) for the purpose of delivering fluid to a body lumen (Fig. 4A, para. 0033).
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 body in De Bruyne to position an additional aperture proximally on the elongated body relative to the flexible member, as taught by Hallisey, in order to provide a way for the elongate body of De Bruyne to deliver infusion liquid upstream from the occlusion (para. 0033 of Hallisey), thereby protecting material or tissues proximal of the occlusion during the procedure, as desired by De Bruyne (para. 0045 of De Bruyne: “the infusion liquid is a liquid brought to a temperature protecting the material or tissues of the wall of the conduit. This temperature can be a temperature that is sufficiently cold to hibernate the tissues of the channel to be protected during a predetermined period of time”).
However, the combination of De Bruyne and Hallisey is silent regarding wherein the flexible member expands to a diameter of substantially 3 cm to 4 cm.
Kiminami in the same field of endeavor of occlusion balloon catheters 10 for use in the esophagus (Fig. 3, para. 0003: “A catheter attached to a balloon (for example, a balloon catheter) can be employed in a biological organ dilating method of placing a stent in a stenosis of the blood vessel or body cavity (for example, a biological lumen such as…esophagus…to secure a body cavity space”) teaches that it is known in the art for a flexible member 11 to expand to a diameter of substantially 3 cm (which equates to 30 mm) (para. 0025-0026: “An exemplary balloon 11 for catheter can be composed of a tubular film body 2 that is inflatable or deflatable by the action of a fluid to be supplied from a catheter…The size of the balloon for catheter can be such that an outer diameter of the tubular film body in inflated state is 1.0 to 35.0 mm, for example, 1.5 to 30.0 mm”).
Thus, one skilled in the art would have readily recognized that modifying the flexible member of modified De Bruyne such that expands to the diameter of substantially 3 cm, as taught by Kiminami, would provide the flexible member of modified De Bruyne with a diameter sufficient enough to dilate a body lumen such as the esophagus (para. 0025 of Kiminani: “The balloon 11 can have a tubular portion having a substantially uniform outer diameter for permitting dilation of a stenosis of a lumen in the body such as a blood vessel, a urinary duct, a billary duct or the like”).
Regarding claim 59, as discussed above, it would have been obvious to modify the system De Bruyne in view of Hallisey and Kiminani. Additionally, De Bruyne disclose discloses all of the limitations set forth above in claim 56. Modified De Bruyne further discloses that “The inflation and deflation of the balloon, for example situated between one and several centimeters or several millimeters upstream from the distal lateral infusion orifices” in para. 0153 of De Bruyne”.
However, the combination above is silent regarding wherein the flexible member is about 0.1 inches to about 5 inches from the distal end of the elongate body.
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 distance between the flexible member and the distal end of the elongated body of modified De Bruyne such that the flexible member is about 0.1 inches to about 5 inches from the distal end of the elongate body since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
In the instant case, the distance between the flexible member and the distal end of the elongate body of modified De Bruyne would not operate differently with the claimed distance range and since the flexible member is intended to be distanced from the distal end of the elongate body (see Fig. 6 of De Bruyne and para. 0153 of De Bruyne). Therefore, having the distance between the flexible member and the distal end of the elongated body of modified De Bruyne such that the flexible member is about 0.1 inches to about 5 inches from the distal end of the elongate body would function appropriately having the claimed angle.
Further, it appears that applicant places no criticality on the distance claimed, indicating simply that “In some embodiments, the flexible member 1214 is about 0.1 inches to about 5 inches from the distal end of the inner shaft 1210. In some embodiments, the flexible member 1214 is about 0.8 inches to about 1.2 inches from the distal end, shown as cap 1224, of the inner shaft 1210.” (para. 00127 of the instant application). Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Regarding claim 61, as discussed above, it would have been obvious to modify the system De Bruyne in view of Hallisey and Kiminani. Additionally, De Bruyne discloses wherein the flexible member 170 is configured to retain an inflation fluid when the inflation fluid flows out of the second aperture 184 of the elongate body 112 to configure the flexible member 170 in the expanded configuration (Fig. 7, para. 0152 of De Bruyne: “a third lumen 82, 182, 282, 382, communicating via an opening 84, 184, 284, 384 with the interior of the obstruction element, here a balloon 72, 172, 272, 372, which can be deflated to a rest position or inflated from this rest position to an inflated working position”).
Regarding claims 62-63, as discussed above, it would have been obvious to modify the system De Bruyne in view of Hallisey and Kiminani. Additionally, De Bruyne discloses wherein the elongate body comprises a distal tip 112c disposed at the distal end of the elongate body (see Fig. 6 of De Bruyne; The examiner notes that the distal tip 112c is discussed in para. 0125 of De Bruyne as “a leaktight partition 114c” which correlates the distal tip of the embodiment of Figs. 1-4, “leaktight partition 12c” in para. 0109) and the guidewire lumen 128 includes a distal end comprising a distal opening extending out of the distal end of the distal tip 112c in which the guidewire 130 extends therethrough (Fig. 6, para. 0150).
However, the combination above is silent regarding (i) [claim 62] wherein the distal tip comprises a valve configured to prevent the liquid from exiting the distal tip of the elongate body and (ii) [claim 63] further comprising a cap connected to the distal tip of the elongate body, the cap defining a bore therethrough such that an elongate device can be passed through the elongate body and out the bore defined by the cap (claim 54).
Hallisey further teaches wherein the elongate body 210 can further comprise a distal tip 230 disposed at the distal end of the elongate body 210 (Fig. 4A, para. 0034 of Hallisey), wherein the distal tip 230 comprises a valve 236 configured to prevent the liquid from exiting the distal tip 230 of the elongate body (Fig. 4A, para. 0034) and a cap 235 connected to the distal tip 230 of the elongate body (Fig. 4A, para. 0034), the cap 235 defining a bore (interpreted as distal opening defined by cap 235, see Fig. 4A) therethrough such that a guidewire can be passed through the elongate body and out the bore defined by the cap without losing infusion liquid flowing through a lumen 213 of the elongated body (Fig. 4A, para. 0034 of Hallisey).
In light of this teaching, 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 closed distal tip comprising the distal opening of the guidewire lumen in modified De Bruyne to have the valve and the cap comprising the bore, as taught by Hallisey, such that the distal end of the guidewire lumen of modified De Bruyne would end at the valve of Hallisey and the guidewire of modified De Bruyne would extend through the valve and the bore provided by the cap of Hallisey. Such a modification would provide an alternative way to prevent infusion liquid from exiting the distal tip as discussed in Hallisey (para. 0034 of Hallisey) and desired in De Bruyne (para. 0125 of De Bruyne), but also prevent particles from destroying an obstruction from entering the distal end of the guidewire lumen (see Fig. 10, para. 0158 of De Bruyne: “This guidewire is advanced into the distal part of the artery, through the occlusion responsible for the infarct”).
Regarding claim 66, modified De Bruyne discloses wherein the fluid is gas (para. 0111 of De Bruyne: “the balloon inflation fluid, for example a gas such as air, or a liquid, may comprise an undiluted contrast agent”).
Claim(s) 67 is rejected under 35 U.S.C. 103 as being unpatentable over De Bruyne (US 20190290889) in view of Hallisey et al. (US 20190298389) [hereinafter Hallisey] and Bareau et al. (US 20170043142) [hereinafter Bareau].
Regarding claim 67, De Bruyne discloses a device configured to block at least a portion of a lumen of a gastrointestinal tract during an endoscopy procedure (Fig. 10, para. 0001: “The invention relates to an infusion catheter device designed to be able to be introduced into a conduit comprising at least one partial or total obstruction to be treated. In particular, the invention relates to an infusion catheter device which can be introduced into a channel of the body of an animal or human being, chosen from the group consisting of…the esophagus”), the system comprising:
a flow reducing device 110 (Fig. 5, para. 0123) comprising:
an infusion lumen 182 configured to receive at least one of a liquid or a gas (Fig. 6, para. 0152: “a third lumen 82, 182, 282, 382, communicating via an opening 84, 184, 284, 384 with the interior of the obstruction element, here a balloon 72, 172, 272, 372, which can be deflated to a rest position or inflated from this rest position to an inflated working position”; para. 0152: “This balloon inflation can be performed from the channel LC proximally by insufflation of a gas or a liquid”));
a guidewire lumen 128 configured for a guidewire 130 to pass therethrough (Figs. 6-7, para. 0150 (para. 0150: “a first lateral channel 128, called monorail, defining a first lateral lumen, shown in FIGS. 5 to 10, which allows the catheter to be advanced on any guidewire 30, 130”);
wherein at least a portion of the guidewire lumen 128 is parallel to the infusion lumen 182 (see Figs. 6-7);
a lumen 114 configured to deliver another fluid into the gastrointestinal tract (Fig. 6 para. 0001: “the invention relates to an infusion catheter device which can be introduced into a channel of the body of an animal or human being, chosen from the group consisting of…the esophagus” and para. 0125: “the second channel 114 is closed at its distal end by a leaktight partition 114c in order to force the infusion liquid to pass through the infusion orifices 116”);
an elongate body 112 having a proximal end and a distal end and defining the infusion lumen 182, the guidewire lumen 128, and the lumen 114 therethrough (see Fig. 6), the elongate body further comprising a flexible member 170 (Fig. 6, para. 0123: “the sealing element 170, such as a balloon 172”) and defining at least two apertures 116, 184, a first aperture (interpreted as one of the plurality of infusion orifices 116) positioned distally on the elongate body 112 relative to the flexible member 170 (see Fig. 6, para. 0125) and a second aperture 184 positioned within the flexible member 170, the second aperture 184 being configured to inflate the flexible member (see Fig. 6, para. 0152);
wherein the second aperture 184 is in communication with the infusion lumen 182 (see Fig. 6);
the fluid delivered through the first aperture comprises saline (para. 0163: “After about 10 minutes, the infusion liquid, for example physiological saline”);
wherein at least a portion of the elongate body 112 extends through an entirety of a length of the flexible member 170 (see Figs. 6);
wherein the flexible member 170 is coupled to a proximal position of the elongate body 112 (interpreted as the proximal end of the flexible member coupled to a proximal portion of the elongate body, see Fig. 6) and a distal position of the elongate body (interpreted as the distal end of the flexible member coupled to a proximal portion of the elongate body, see Fig. 6);
wherein the flexible member 170 is inflatable to an expanded configuration from an unexpanded configuration when the fluid flows through the infusion lumen 182 of the elongate body 112 and out the second aperture 184 of the elongate body 112 (para. 0152); and
wherein the first aperture 116 is in communication with the lumen 114 and is configured to deliver the fluid into the gastrointestinal tract (para. 0125).
De Bruyne is silent regarding a first aperture positioned proximally on the elongate body relative to the flexible member.
Hallisey in the same field of endeavor of occlusion balloon catheters (para. 0033, 0035) teaches that it is known in the art to for an elongate body 210 to have a first aperture 215 positioned proximally on the elongate body 210 relative to a flexible member 250 (Fig. 4A, para. 0033) for the purpose of delivering fluid to a body lumen (Fig. 4A, para. 0033).
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 body in De Bruyne to position an additional aperture proximally on the elongated body relative to the flexible member, as taught by Hallisey, in order to provide a way for the elongate body of De Bruyne to deliver infusion liquid upstream from the occlusion (para. 0033 of Hallisey), thereby protecting material or tissues proximal of the occlusion during the procedure, as desired by De Bruyne (para. 0045 of De Bruyne: “the infusion liquid is a liquid brought to a temperature protecting the material or tissues of the wall of the conduit. This temperature can be a temperature that is sufficiently cold to hibernate the tissues of the channel to be protected during a predetermined period of time”).
However, the combination of De Bruyne and Hallisey is silent regarding the fluid comprising contrast as well as the saline.
Bareau in the same field of endeavor of occlusion balloon catheters positioned within the gastrointestinal tract (para. 0012) teaches that it is known in the art to use fluid comprising saline and contrast for the purpose of providing a glow-in-the-dark phosphorescent affect during use (para. 0051).
In light of this teaching, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the saline/contrast fluid material as taught by Bareau opposed to the saline-only material in modified De Bruyne since Bareau teaches that the inclusion of contrast provides an additional benefit of phosphorescent qualities which would improve visibility of S target site during use (para. 0051 of Bareau). Furthermore, it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use. (In re Leshin 125 USPQ 416; MPEP 2144.07)
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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/LAUREN DUBOSE/Examiner, Art Unit 3771
/Andrew Restaino/Primary Examiner, Art Unit 3771
