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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/12/2026 has been entered.
Response to Amendments
The amendment to 58 is acknowledged and the previous claim objections are withdrawn.
The examiner notes that the broadest reasonable interpretation of “substantially” is acknowledged by applicant, and the 112(b) rejection is withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 28, 56, and 67 filed 03/12/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Upon further consideration, a new ground(s) of rejection is made in view of Okada et al. (US 20170079509) in view of Hallisey et al. (US 20190298389) and Farhadi (US 20160081537) for the rejection of claim 28, Okada et al. (US 20170079509) in view of Hallisey et al. (US 20190298389) for the rejection of claim 56, and Okada et al. (US 20170079509) in view of Hallisey et al. (US 20190298389), Bareau et al. (US 20170043142) and Belfort et al. (US 20080215031) for the rejection of claim 67.
Claim Objections
Claim 56 is objected to because of the following informalities:
Claim 56, lines 11-12: “wherein the flexible member is coupled to a proximal position of the elongate body and a distal position of the elongate body;” was previously recited in lines 3-4 of claim 56 and must be deleted. 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, 52-55, and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Okada et al. (US 20170079509) [hereinafter Okada] in view of Hallisey et al. (US 20190298389) [hereinafter Hallisey] and Farhadi (US 20160081537).
Regarding claim 28, Okada et al. (US 20170079509) discloses a system (Fig. 1) configured to block at least a portion of a lumen of a gastrointestinal tract during an endoscopy procedure (Fig. 4A, para. 0067), the system comprising:
a flow reducing device 60 (Fig. 2, para. 0053) comprising:
an elongate body 62 having a proximal end 64 and a distal end (interpreted as end comprising distal opening of lumen 62b; Fig. 2, para. 0052-0053) and defining a lumen 62a therethrough (Fig. 2, para. 0053), the elongate body further comprising a flexible member 70 and defining at least two apertures (see Fig. 2), a first aperture positioned distally on the elongate body 62 relative to the flexible member 70 (interpreted as distal aperture of lumen 62b, para. 0053) and a second aperture 62c positioned within the flexible member 70 (Fig. 2, para. 0058), the second aperture 62c being configured to inflate the flexible member 70 (Fig. 2, para. 0058);
wherein at least a portion of the elongate body 62 extends through an entirety of a length of the flexible member 70 (Fig. 2);
wherein the flexible member 70 is coupled to a proximal position of the elongate body 62 and a distal position of the elongate body 62 (see Fig. 2);
wherein the flexible member 70 is inflatable to an expanded configuration from an unexpanded configuration when a fluid flows through the lumen 62a of the elongate body 62 and out the second aperture 62c of the elongate body 62 (Fig. 2, para. 0058);
wherein the first aperture is configured to deliver the fluid into the gastrointestinal tract (Fig. 2, para. 0053);
However, Okada fails to disclose the 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) and a flow restriction member 230 at a distal end of the elongated body 210 in order to direct fluid to the first aperture and still provide a way for passage of an instrument out the flow restriction member (para. 0034).
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 Okada to position the first aperture proximally on the elongated body relative to the flexible member and to include the flow restriction member, as taught by Hallisey in order to provide a way to lubricate an endoscope while positioned within a second lumen 62b (Fig. 2, para. 0054 of Okada; see Fig. 4A of Hallisey which illustrate fluid within lumen 213 which is analogous to lumen 62b) and deliver fluid to a target site without obstructing a view of an endoscope distally lubricate the endoscope (Fig. 4A, para. 0087 of Okada) by way of the proximal first aperture (Fig. 4A, para. 0033 of Hallisey).
Modified Okada further discloses the use of an endoscope for observing an affected part 400 (Fig. 4A, para. 0087 of Okada). However, modified Okada fails to disclose an echoendoscope.
Farhadi teaches that an echoendoscope is a known alternative in the art for an endoscope (para. 0003) in order to image at least a portion of a gastrointestinal tract (para. 0003, 0050).
The substitution of one known endoscope (echoendoscope as shown in Farhadi) for another (endoscope as shown in modified Okada) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the echoendoscope shown in Farhadi would have yielded predictable results, namely, an alternative way for a user to view the gastrointestinal tract using a combination of endoscopy and ultrasound (para. 0003 of Farhadi).
Regarding claim 50, modified Okada discloses all of the limitations set forth above in claim 28. However, modified Okada discloses fails to disclose wherein the flexible member is about 0.1 inches to about 5 inches from the distal end of the elongate body.
There is no evidence of record that establishes that changing the distance between the flexible member and the distal end of the elongated body would result in a difference in function of the modified Bareau device. Further, a person having ordinary skill in the art, being faced with modifying the distance between the flexible member and the distal end of the elongated body of modified Okada, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed distance dimension would still result in the flexible member being positioned proximal to the distal end of the elongated body (see Figs. 2 and 4 of Okada) and since the device is also used to occlude a portion of the GI tract (Fig. 4, 0067 of Okada). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating in para. 00127 of the instant application 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.”. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Hence, 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 Okada to have the flexible member be about 0.1 inches to about 5 inches from the distal end of the elongate body as an obvious matter of design choice within the skill of the art.
Regarding claim 52, modified Okada discloses wherein the flexible member 70 is configured to retain an inflation fluid when the inflation fluid flows out of the second aperture 62c of the elongate body 62 to configure the flexible member 70 in the expanded configuration (Fig. 2, para. 0058 of Okada).
Regarding claim 53, modified Okada discloses wherein the elongate body comprises a distal tip 230 disposed at the distal end of the elongate body (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 of Hallisey).
Regarding claim 54, modified Bareau discloses a cap 235 connected to the distal tip 230 of the elongate body (Fig. 4A, para. 0034 of Hallisey), the cap 235 defining a bore (interpreted as distal opening defined by cap 235, see Fig. 4A) therethrough such that an elongate device can be passed through the elongate body and out the bore defined by the cap (Fig. 4A, para. 0034 of Hallisey).
Regarding claim 55, modified Okada discloses a third lumen 62b configured to receive a substance therethrough (Fig. 2, para. 0053 of Okada; The examiner notes that “a second lumen” is not claimed. Claim 55 depends from claim 28 which only introduces “a lumen” for expanding the flexible member through “a second aperture” and “a first aperture” for delivering fluid into the GI tract.)
Regarding claim 65, modified Okada discloses wherein the fluid is gas (para. 0058 of Okada: “Specifically, the fixing portion 70 expands if gas is supplied to the internal spatial portion of the fixing portion 70”).
Claim(s) 56, 58-59, 61-64, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Okada et al. (US 20170079509) [hereinafter Okada] in view of Hallisey et al. (US 20190298389) [hereinafter Hallisey].
Regarding claim 56, Okada discloses an inflatable endoscopic device 60 (Fig. 1, para. 0051) comprising:
an elongate body 62 having a proximal end 64 and a distal end (interpreted as end comprising distal opening of lumen 62b; Fig. 2, para. 0052-0053) and defining a lumen 62a therethrough (Fig. 2, para. 0053), the elongate body further comprising a flexible member 70 coupled to a proximal position of the elongate body 62 and a distal position of the elongate body 62 (see Fig. 2), the elongate body 62 defining two or more apertures (see Fig. 2), a first aperture positioned distally on the elongate body 62 relative to the flexible member 70 (interpreted as distal aperture of lumen 62b, para. 0053) and a second aperture 62c disposed between the proximal position of the elongate body 62 and the distal position of the elongate body 62 (Fig. 2, para. 0058), the second aperture 62c being configured to inflate the flexible member 70 (Fig. 2, para. 0058);
wherein at least a portion of the elongate body 62 extends through an entirety of a length ofthe flexible member 70 (Fig. 2);
wherein the flexible member 70 is coupled to a proximal position of the elongate body 62 and a distal position of the elongate body 62 (see Fig. 2; see claim objection above);
wherein the flexible member 70 is inflatable to an expanded configuration from an unexpanded configuration when a fluid flows through the lumen 62a of the elongate body 62 and out the second aperture 62c of the elongate body 62 (Fig. 2, para. 0058);
However, Okada fails to disclose the 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) and a flow restriction member 230 at a distal end of the elongated body 210 in order to direct fluid to the first aperture and still provide a way for passage of an instrument out the flow restriction member (para. 0034).
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 Okada to position the first aperture proximally on the elongated body relative to the flexible member and to include the flow restriction member, as taught by Hallisey in order to provide a way to lubricate an endoscope while positioned within a second lumen 62b (Fig. 2, para. 0054 of Okada; see Fig. 4A of Hallisey which illustrate fluid within lumen 213 which is analogous to lumen 62b) and deliver fluid to a target site without obstructing a view of an endoscope distally lubricate the endoscope (Fig. 4A, para. 0087 of Okada) by way of the proximal first aperture (Fig. 4A, para. 0033 of Hallisey).
However, modified Okada fails to disclose wherein the flexible member expands to a diameter of substantially 3 cm to 4 cm.
There is no evidence of record that establishes that changing the expanded diameter of the flexible member of modified Okada would result in a difference in function of the modified Okada device. Further, a person having ordinary skill in the art, being faced with modifying the flexible member of modified Okada, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed diameter range since the device is also used to occlude a portion of the GI tract (Fig. 4, 0067 of Okada). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating simply that “the flexible member expands to a diameter of substantially or about 2 cm to about 4 cm, about 1.5 cm to about 4.5 cm, about 3 cm to about 5 cm, about 1 cm to about 3 cm, etc.” in para. 00128 in the instant application. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Hence, 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 flexible member of modified Okada to have an expanded diameter of substantially 3 cm to 4 cm 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 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 US 830, 225 SPQ 232 (1984).
Regarding claim 58, modified Okada discloses wherein the first aperture is configured to deliver the fluid into the gastrointestinal tract (Fig. 2, para. 0053 of Okada).
Regarding claim 59, modified Okada discloses all of the limitations set forth above in claim 28. However, modified Okada discloses fails to disclose wherein the flexible member is about 0.1 inches to about 5 inches from the distal end of the elongate body.
There is no evidence of record that establishes that changing the distance between the flexible member and the distal end of the elongated body would result in a difference in function of the modified Bareau device. Further, a person having ordinary skill in the art, being faced with modifying the distance between the flexible member and the distal end of the elongated body of modified Okada, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed distance dimension would still result in the flexible member being positioned proximal to the distal end of the elongated body (see Figs. 2 and 4 of Okada) and since the device is also used to occlude a portion of the GI tract (Fig. 4, 0067 of Okada). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating in para. 00127 of the instant application 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.”. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Hence, 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 Okada to have the flexible member be about 0.1 inches to about 5 inches from the distal end of the elongate body as an obvious matter of design choice within the skill of the art.
Regarding claim 61, modified Okada discloses wherein the flexible member 70 is configured to retain an inflation fluid when the inflation fluid flows out of the second aperture 62c of the elongate body 62 to configure the flexible member 70 in the expanded configuration (Fig. 2, para. 0058 of Okada).
Regarding claim 62, modified Okada discloses wherein the elongate body comprises a distal tip 230 disposed at the distal end of the elongate body (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 of Hallisey).
Regarding claim 63, modified Bareau discloses a cap 235 connected to the distal tip 230 of the elongate body (Fig. 4A, para. 0034 of Hallisey), the cap 235 defining a bore (interpreted as distal opening defined by cap 235, see Fig. 4A) therethrough such that an elongate device can be passed through the elongate body and out the bore defined by the cap (Fig. 4A, para. 0034 of Hallisey).
Regarding claim 64, modified Okada discloses a third lumen 62b configured to receive a substance therethrough (Fig. 2, para. 0053 of Okada; The examiner notes that “a second lumen” is not claimed. Claim 55 depends from claim 28 which only introduces “a lumen” for expanding the flexible member through “a second aperture” and “a first aperture” for delivering fluid into the GI tract.)
Regarding claim 66, modified Okada discloses wherein the fluid is gas (para. 0058 of Okada: “Specifically, the fixing portion 70 expands if gas is supplied to the internal spatial portion of the fixing portion 70”).
Claim(s) 67 is rejected under 35 U.S.C. 103 as being unpatentable over Okada et al. (US 20170079509) [hereinafter Okada] in view of Hallisey et al. (US 20190298389) [hereinafter Hallisey], Bareau et al. (US 20170043142) [hereinafter Bareau] and Belfort et al. (US 20080215031) [hereinafter Belfort].
Regarding claim 67, Okada discloses a device 60 (Figs. 1, 4A) configured to block at least a portion of a lumen of a gastrointestinal tract during an endoscopy procedure (Fig. 4A, para. 0067), the system comprising:
an elongate body 62 having a proximal end 64 and a distal end (interpreted as end comprising distal opening of lumen 62b; Fig. 2, para. 0052-0053) and defining a lumen 62a therethrough (Fig. 2, para. 0053), the elongate body further comprising a flexible member 70 and defining at least two apertures (see Fig. 2), a first aperture positioned distally on the elongate body 62 relative to the flexible member 70 (interpreted as distal aperture of lumen 62b, para. 0053) and a second aperture 62c positioned within the flexible member 70 (Fig. 2, para. 0058), the second aperture 62c being configured to inflate the flexible member 70 (Fig. 2, para. 0058);
wherein at least a portion of the elongate body 62 extends through an entirety of a length ofthe flexible member 70 (Fig. 2);
wherein the flexible member 70 is coupled to a proximal position of the elongate body 62 and a distal position of the elongate body 62 (see Fig. 2); and
wherein the flexible member is inflatable to an expanded configuration from an unexpanded configuration when at least one of a liquid or a gas flows through the lumen of the elongate body and out the second aperture of the elongate body.
wherein the flexible member 70 is inflatable to an expanded configuration from an unexpanded configuration when at least one of a liquid or a gas flows through the lumen 62a of the elongate body 62 and out the second aperture 62c of the elongate body 62 (Fig. 2, para. 0058);
wherein the first aperture is configured to deliver the fluid into the gastrointestinal tract (Fig. 2, para. 0053);
However, Okada fails to disclose the 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) and a flow restriction member 230 at a distal end of the elongated body 210 in order to direct fluid to the first aperture and still provide a way for passage of an instrument out the flow restriction member (para. 0034).
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 Okada to position the first aperture proximally on the elongated body relative to the flexible member and to include the flow restriction member, as taught by Hallisey in order to provide a way to lubricate an endoscope while positioned within a second lumen 62b (Fig. 2, para. 0054 of Okada; see Fig. 4A of Hallisey which illustrate fluid within lumen 213 which is analogous to lumen 62b) and deliver fluid to a target site without obstructing a view of an endoscope distally lubricate the endoscope (Fig. 4A, para. 0087 of Okada) by way of the proximal first aperture (Fig. 4A, para. 0033 of Hallisey).
Modified Okada further discloses the first aperture is configured to deliver the fluid into the gastrointestinal tract (Fig. 2, para. 0053 of Okada), wherein the fluid may be water (para.0054 of Okada). However, Okada fails to disclose a fluid comprising saline and contrast.
Belfort in the same field of endeavor of occlusion balloon catheters configured to be positioned within the GI tract (para. 0007, 0014) teaches that it is known in the art to deliver cleansing/hydrating fluids (e.g. water or saline) and therapeutic agents such as pharmaceuticals (para. 0042) to a body cavity such as the GI tract.
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 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 use the saline/contrast fluid material as taught by Bareau and Belfort opposed to the water material in modified Okada since Belfort teaches that saline in combination with other substances (para. 0042 of Belfort) is a known alternative in the art and 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
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771