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 .
Status of Claims
Claims 1, 3-15, 17, 19-20, and 22-30 are pending, claims 2, 16, 18, and 21 have been cancelled, and claims 1, 3-15, 17, 19-20, and 22-30 are currently under consideration for patentability under 37 CFR 1.104. Previous claim and drawing objections and 35 USC 112 rejections are withdrawn in light of Applicant’s arguments and amendments.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/15/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15, 17, 19-20, and 22-30 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3-6, 8-9, 11-15, 17, 19-20, 23-24, 26-27, and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflang (US 2015/0327754), in view of Fonger (US 2017/0319233) with evidence from Vian & Denton (2018, NPL was previously included | for claim 29).
Regarding claim 1, Leeflang discloses a surgical access device (figure 12a), comprising: an elongate body (310, figure 12a) having a working channel (see lumen of 310, figure 12a); a balloon visualization module (330 and 340, figures 12b and 12e) positioned at the distal end of the elongate body, the balloon visualization module comprising a balloon (330, figure 12b) with a camera module (340, figure 12e) positioned within the balloon (see figure 12b), wherein when in a stowed configuration (see figure 12a), the camera module is configured to be contained within an outer diameter of an access sheath (see diameter of 330, figure 12a) and when deployed in use with an inflated balloon (figure 12b), the camera module moves radially outwardly relative to a longitudinal axis of the elongate body to a position substantially beyond an outer wall of the elongate body (see figure 12b); a channel extension (see 320 and 325, figure 12a). Leeflang is silent regarding the channel extension, resembling a half or partial pipe shape, comprising a flexible tube coupled to a distal end of the working channel, wherein when in the stowed configuration in which the balloon is deflated, the balloon visualization module is positioned completely within the channel extension at the distal end of the elongate body; wherein the channel extension comprises a lumen and a cut out portion through which the balloon visualization module is configured to at least partially emerge upon inflation of the balloon.
Fonger teaches an access device (10, figure 1a) with a head portion (40, figure 1), a shaft (20, figure1), and a handle portion (30, figure 1). The head portion (40, figure 4) has a balloon (42, figures 4 and 6 and 8), a camera (41, figures 4-8), and an instrument channel opening (44, figures 6-7). The balloon (42, figure 6) can be inflated to assist in moving tissue from the treatment region and can provide a directed downward force to stabilize the head portion ([0052]).
It would have been obvious to modify the device of Leeflang with the balloon (42, figure 6) and its surrounding head portion (40, figure 6 | opening from which the balloon…[0056]) as taught by Fonger. Doing so would provide a balloon that extends from an opening on the top surface to stabilize the head portion ([0052] and [0056]). The modified device would have the channel extension (opening from which the balloon…extend [0056]; see 40, figure 6; Fonger), resembling a half or partial pipe shape (opening from which the balloon…extend [0056]; see 40, figures 6 and 10-11), comprising a flexible tube (flexibility…polymer [0086] | head portion 40…polymer [0088] | see 44, figure 6) coupled to a distal end of the working channel, wherein when in the stowed configuration in which the balloon is deflated, the balloon visualization module is positioned completely within the channel extension at the distal end of the elongate body (see 42, figure 6); wherein the channel extension comprises a lumen (opening…extend [0056] | see figure 11 | interpreted there to be a lumen to stow the balloon visualization module inside the channel extension) and a cut out (opening from which the balloon…extend [0056]) portion through which the balloon visualization module is configured to at least partially emerge upon inflation of the balloon (see figures 12a vs. 12b; Leeflang | the modified balloon visualization module would be stowed inside the channel extension).
Regarding claim 3, Leeflang further discloses at least a portion of a distal surface of the balloon forms a contact visualization surface configured to contact target tissue and allow visualization of the target tissue therethrough by the camera module (contact with tissue [0080] | field of view…[0088]; Leeflang).
Regarding claim 4, Leeflang further discloses at least 90% of the distal surface of the balloon is within a field of view of the camera module when the camera module is in a deployed configuration (field of view across the longitudinal axis 316 [0088]; Leeflang).
Regarding claim 5, Leeflang further discloses a distal surface of the balloon is rounded (best seen with 42, figures 10-11; Fonger | see distal surface/end of 330, figure 12b; Leeflang).
Regarding claim 6, Leeflang further discloses the balloon comprises an optically clear material (material…transparent [0052]; Leeflang).
Regarding claim 8, Leeflang further discloses the elongate body comprises a plurality of lumens (primary lumen [0091] | primary lumen 18a..inflation lumen 18b...[0037]; Leeflang).
Regarding claim 9, Leeflang further discloses the elongate body comprises a fluid lumen (infusion lumen…[0038]; Leeflang).
Regarding claim 11, Leeflang further discloses the elongate body comprises a position tracking sensor (electrodes…navigation [0040] | embodiments…not intended to be exhaustive or to limit [0093]; Leeflang).
Regarding claim 12, Leeflang further discloses the camera module comprises a connector, wire or cable (see cable connected to 340, figures 12; Leeflang) extending proximally towards a proximal end of the elongate body (see figure 12b | see cable/wire that extends proximally), to provide data and/or power to the camera module (power source…image data [0058]).
Regarding claim 13, Leeflang further discloses the camera module comprises one or more lights (light sources…340 [0088]; Leeflang).
Regarding claim 14, Leeflang further discloses the camera module is positioned generally parallel to the longitudinal axis of the elongate body (see location of 340, figure 12b | imaging elements…be located at different locations [0088]; Leeflang).
Regarding claim 15, Leeflang further discloses the camera module is positioned at an angle relative to the longitudinal axis of the elongate body (see location of 340, figure 12b | imaging elements…be located at different locations [0088]; Leeflang).
Regarding claim 17, Leeflang further discloses a camera mount configured to attach to the channel extension and support the camera module (tether or other element…[0088]; Leeflang).
Regarding claim 19, Fonger further teaches the balloon, when inflated, is configured to complete the lumen in at least part of the cut out portion (best seen with figures 10-11; Fonger).
Regarding claim 20, Leeflang and Fonger further disclose the cut out portion comprises 60-90% of a length of the channel extension (see length of 320 with respect to the length of 320 with 325, figure 12a; Leeflang | see figures 10-11; Fonger).
Regarding claim 23, Fonger further teaches a bottom central portion of the balloon comprises a balloon channel configured to surround the channel extension (see 42 create a channel over the outer surface of 44 in figure 10; Fonger), the balloon channel being a recessed portion of the balloon having a shape and size configured to correspond to a size of the distal end of the working channel (see 42 over 44 in figure 10; Fonger).
Regarding claim 24, Leeflang and Fonger disclose all of the features in the current invention as shown above in claim 23. They are silent regarding a diameter of the balloon channel is 3-3.8 mm.
Fonger further teaches the outer diameter of the shaft (20, figure 1) is from 10 mm to 20 mm, including about 5, 10, 15, or 20 mm ([0047]). The access device may have a diameter that can be 14 French or smaller ([0083]).
It would have been obvious to modify the outer diameter of the shaft to be 14 French or smaller as taught by Fonger ([0083]). Doing so would provide a device that has a low profile ([0083]). The modified device would have a diameter of the balloon channel is 3-3.8 mm (see the channel created by 42 over 40, figure 10; Fonger | 14 F or smaller [0083] | 14 F is 4.7 mm; the diameter of the balloon channel can be 3-3.8 mm).
Regarding claim 26, Fonger further teaches the balloon is asymmetric around a longitudinal access of the channel extension (see 42, figure 10; Fonger).
Regarding claim 27, Fonger further teaches greater than 80% of a volume of the balloon is positioned above the channel extension (see 42, figure 10; Fonger).
Regarding claim 29, Leeflang further discloses the balloon comprises a durometer of shore 80-90A (polyethylene PE [0051]; Leeflang | see pg. 8 of NPL of Vian & Denton (2018) for data of Shore A for polyethylene is between 80-98A).
Regarding claim 30, Leeflang and Fonger disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the elongate body comprises a diameter of 12-16F.
Fonger further teaches the outer diameter of the shaft (20, figure 1) is from 10 mm to 20 mm, including about 5, 10, 15, or 20 mm ([0047]). The access device may have a diameter that can be 14 French or smaller ([0083]).
It would have been obvious to modify the outer diameter of the shaft to be 14 French or smaller as taught by Fonger ([0083]). Doing so would provide a device that has a low profile ([0083]). The modified device would have the elongate body comprises a diameter of 12-16F (14F or smaller [0083]; Fonger).
Claim(s) 7 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflang (US 2015/0327754) and Fonger (US 2017/0319233) as applied to claims 1 and 23 above, and further in view of Utley (US 2009/0012513).
Regarding claim 7, Leeflang and Fonger disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the camera module is spaced 8-13 mm from a distal surface of the balloon.
Utley teaches an endoscope (100, figure 15) with a shaft (111, figure 15) and an expandable member (105, figure 15) for use in the digestive tract ([0010]). The device has an ablation structure (101, figure 15) and a housing (107, figure 15) with electrical connections (109, figure 15) and an inflation line (113, figure 15). The expandable/balloon member can have an expanded diameter that varies from 12 to 40 mm ([0130]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the device with the size/diameter of the balloon as taught by Utley ([0130]). Doing so would provide a balloon with an expanded diameter to reduce or occlude blood flow at the site of the ablation ([0130]). The modified device would have the camera module is spaced 8-13 mm (see location of 340 with respect to the distal end surface of 320, figure 12b and e; Leeflang | 12-40 mm [0130]; Utley; the modified balloon can have a diameter where the distance between the camera module and distal surface is between 8-13 mm) from a distal surface of the balloon.
Regarding claim 25, Leeflang and Fonger disclose all of the features in the current invention as shown above in claim 23. They are silent regarding a length of the balloon channel is 16-17.4 mm.
Utley teaches an endoscope (100, figure 15) with a shaft (111, figure 15) and an expandable member (105, figure 15) for use in the digestive tract ([0010]). The device has an ablation structure (101, figure 15) and a housing (107, figure 15) with electrical connections (109, figure 15) and an inflation line (113, figure 15). The expandable/balloon member can have an expanded diameter that varies from 12 to 40mm ([0130]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the device with the size/diameter of the balloon as taught by Utley ([0130]). Doing so would provide a balloon with an expanded diameter to reduce or occlude blood flow at the site of the ablation ([0130]). The modified device would have a length of the balloon channel is 16-17.4 mm (diameter from 12-40 mm [0130]; Utley).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Leeflang (US 2015/0327754) and Fonger (US 2017/0319233) as applied to claim 9 above, and further in view of Nitsan (US 2011/0092892).
Leeflang and Fonger disclose all of the features in the current invention as shown above in claim 9. They are silent regarding a diameter of the fluid lumen is 0.4-0.6 mm.
Nitsan teaches a catheter sheath with an extra lumen for introducing air for insufflation of air mixture with the irrigation fluid ([0166]). The lumen can have a very small diameter, such as between 0.2-1 mm ([0166]).
It would have been obvious to one of ordinary skill before the time of filing to modify the device to have a diameter of the fluid lumen 0.2-1 mm ([0166]). Doing so would provide a fluid lumen that has a small diameter ([0166]). The modified device would have a diameter of the fluid lumen is 0.4-0.6 mm (0.2-1 mm [0166]; Nitsan | the fluid lumen diameter can be between 0.4-0.6 mm).
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Leeflang (US 2015/0327754) and Fonger (US 2017/0319233) as applied to claim 1 above, and further in view of Jacobsen (US 2009/0318759).
Leeflang and Fonger disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the channel extension comprises an optically clear material.
Jacobsen teaches a transparent focus instrument (102, figure 1) that can be a hollow space, solid spacer, inflatable or inflated balloon or other such device ([0039]). An imaging device (106, figures 2) is coupled with the transparent focal instrument ([0037]). The spacer can be made of a common transparent plastic ([0039]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the device to have the channel extension be made of a common transparent plastic ([0039]) as taught by Jacobsen. Doing so would allow objects to be imaged (abstract). The modified device would have the channel extension comprises an optically clear material (common transparent plastic [0039]).
Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Leeflang (US 2015/0327754) and Fonger (US 2017/0319233) as applied to claim 1 above, and further in view of Horrisberger (US 2019/0142246).
Leeflang and Fonger disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the balloon comprises a thickness of less than or equal to 0.1 mm.
Horrisberger teaches a visualization catheter with an elongate shaft and an offset balloon ([0006]). The offset balloon can be inflated to have an outer diameter ranging from 1.3-2.5 cm (13-25 mm) and a uniform wall thickness ranging from 0.001-0.01 in (0.0254- 0.254 mm) ([0011]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the device to have a balloon with uniform wall thickness ranging from 0.001-0.01 in (0.0254- 0.254 mm) as taught by Horrisberger ([0011]). Doing so would provide a balloon that has a thickness sized for balloon-based visualization ([0005]). The modified device would have the balloon comprises a thickness of less than or equal to 0.1 mm (0.0254- 0.254 mm [0011]; Horrisberger | the thickness of the balloon can be less than or equal to 0.1 mm).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM.
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PAMELA F. WU
Examiner
Art Unit 3795
September 28, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
