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 1-15, 17, 19-20, and 22-30 are pending, claims 16, 18, and 21 have been cancelled, and claims 1-15, 17, 19-20, and 22-30 are currently under consideration for patentability under 37 CFR 1.104. Previous drawing objection and claim objections are withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-30 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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a channel extension, comprising a flexible tube…the balloon visualization module is positioned within the channel extension at the distal end of the elongate body; wherein the channel extension comprises a lumen with a cut out portion through which the balloon visualization module is configured to at least partially emerge upon inflation of the balloon” (in claim 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. The channel extension (216, figure 2) looks like a barrier that would prevent the balloon visualization module from being stowed in it when deflated. Further, the cut out portion (214, figure 2) looks to be a part of the elongate body (204, figure 2) rather than the channel extension (216, figure 2).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 17 is objected to because of the following informalities: the limitation “claim,” should read “claim 1,”. The Examiner interpreted the missing “1” to be accidentally struck through and will interpret claim 17 to be dependent on claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15, 17, 19-20, and 22-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the limitation “the channel extension comprises a lumen with a cut out portion through which the balloon visualization module is configured to at least partially emerge upon inflation of the balloon” is unclear. It is unclear how a lumen, which is interpreted as a cavity or space within a channel, can have a cut out portion. Claims 2-15, 17, 19-20, and 22-30 are rejected due to their dependency on claim 1.
Regarding claim 2, the limitation “the balloon visualization module is completely within the working channel when stowed” is unclear with respect to the limitation “when in the stowed configuration…the balloon visualization module is positioned within the channel extension” in claim 1. It is unclear where the balloon visualization module is when stowed.
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) 1-6, 8-9, 11-15, 17, 19-20, 23, 26-27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflang (US 2015/0327754), 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); and a channel extension (see 320 and 325, figure 12a), comprising a flexible tube coupled to a distal end of the working channel (see 320 in collapsed condition in figure 12a and 12c vs. expanded condition in figures 12b, 12d, and 12e | sufficiently flexible [0089]), wherein when in the stowed configuration in which the balloon is deflated, the balloon visualization module is positioned within the channel extension at the distal end of the elongate body (see 330, figure 12a; the balloon 330 is within the outer diameter of 324); wherein the channel extension comprises a lumen with a cut out portion (see opened up space around 320s, figures 12) through which the balloon visualization module is configured to at least partially emerge upon inflation of the balloon (best seen with figure 12c-e).
Regarding claim 2, Leeflang further discloses the balloon visualization module is completely within the working channel when stowed (see 112b rejection above | see the diameter of the balloon 330 is within the boundary/range of the working channel/lumen of 310, figure 12a).
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]).
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] | imaging elements…located at different locations…[0088]).
Regarding claim 5, Leeflang further discloses a distal surface of the balloon is rounded (see distal surface/end of 330, figure 12b).
Regarding claim 6, Leeflang further discloses the balloon comprises an optically clear material (material…transparent [0052]).
Regarding claim 8, Leeflang further discloses the elongate body comprises a plurality of lumens (primary lumen [0091] | primary lumen 18a..inflation lumen 18b...[0037] | embodiments…not intended to be exhaustive or to limit [0093]).
Regarding claim 9, Leeflang further discloses the elongate body comprises a fluid lumen (infusion lumen…[0038]).
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]).
Regarding claim 12, Leeflang further discloses the camera module comprises a connector, wire or cable (see cable connected to 340, figures 12) 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]).
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]; can be located to be parallel to the longitudinal axis).
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]).
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]).
Regarding claim 19, Leeflang further discloses the balloon, when inflated, is configured to complete the lumen in at least part of the cut out portion (see figure 12e | expand asymmetrically to define a channel or recess…[0091]).
Regarding claim 20, Leeflang further discloses 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).
Regarding claim 23, Leeflang further discloses a bottom central portion of the balloon comprises a balloon channel (see bottom portion of 330, figure 12e) configured to surround the channel extension (see figure 12b), the balloon channel being a recessed portion of the balloon (see lower/bottom portion of 330, figures 12c-e) having a shape and size configured to correspond to a size of the distal end of the working channel (see figure 12b and 12e).
Regarding claim 26, Leeflang further discloses the balloon is asymmetric around a longitudinal access of the channel extension (see figure 12e).
Regarding claim 27, Leeflang further discloses greater than 80% of a volume of the balloon is positioned above the channel extension (see figure 12b and 12e).
Regarding claim 29, Leeflang further discloses the balloon comprises a durometer of shore 80-90A (polyethylene PE [0051] | see pg. 8 of NPL of Vian & Denton (2018) for data of Shore A for polyethylene is between 80-98A).
Claim(s) 7 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflang (US 2015/0327754) as applied to claims 1 and 23 above, and further in view of Utley (US 2009/0012513).
Regarding claim 7, Leeflang discloses 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 of Leeflang 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 24, Leeflang discloses 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.
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]). An ablation device can be passed through a working channel of the endoscope, where the dimensions of the channel are typically 2-5 mm in diameter ([0232]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the device of Leeflang with a working channel that has a diameter of 2-5 mm ([0232]) as taught by Utley. Doing so would provide a common dimension for a working channel ([0232]). The modified device would have a diameter of the balloon channel is 3-3.8 mm (see 2-5 mm in diameter [0232]; Utley).
Regarding claim 25, Leeflang discloses 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 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 of Leeflang 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) as applied to claim 9 above, and further in view of Nitsan (US 2011/0092892).
Leeflang discloses 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 in the 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) as applied to claim 1 above, and further in view of Jacobsen (US 2009/0318759).
Leeflang further discloses the channel extension comprises a material (Nitinol, plastic, and the like…[0047]). However, Leeflang is 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 (Nitinol, plastic, and the like…[0047]; Leeflang | common transparent plastic [0039]).
Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Leeflang (US 2015/0327754) as applied to claim 1 above, and further in view of Horrisberger (US 2019/0142246).
Leeflang discloses 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 of Leeflang 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).
Claim(s) 30 is rejected under 35 U.S.C. 103 as being unpatentable over Leeflang (US 2015/0327754) as applied to claim 1 above, and further in view of Anderson (US 2019/0117044).
Leeflang discloses 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.
Anderson teaches a visualization catheter, where the diameter of the catheter is 12 French or 4 mm ([0105]) to accommodate a delivery lumen and axially-facing camera ([0105]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the device of Leeflang to have the elongate body have a diameter of 12 F as taught by Anderson ([0105]). Doing so would provide enough space to accommodate for a delivery lumen and camera ([0105]). The modified device would have the elongate body comprises a diameter of 12-16F (12F…; [0105]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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
December 4, 2025
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795