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 1-21 are pending and are currently under consideration for patentability under 37 CFR 1.104.
Claim Objections
Claim 12 is objected to because of the following informalities: change “of from” to “from”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claim 3, the limitation “the at least one pull wire residing within the working channel of the shaft” is not disclosed in the specification. Although the specification discusses at least one pull wire, the specification does not describe the at least one pull wire residing within the working channel. Claims 4-6 are rejected due to their dependency on claim 3.
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 15-21 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 15, the limitation “the catheter device” is unclear as it was not previously recited. It is unclear if this feature is the same feature as the treatment catheter recited in claim 1. Claim 16 is rejected due to its dependency on claim 15.
Regarding claim 16, the limitation “the incorporation of the shaft of the camera sheath assembly and the treatment catheter” is unclear. It is unclear what “incorporation” means with respect to this limitation.
Regarding claim 17, the limitation “into the airway” is unclear. It is unclear what the airway is referring to (i.e., not previously recited).
Regarding claims 19-20, the limitation “delivering energy to from the at least one energy emitter” is unclear. It is unclear if energy is being delivered to or being delivered from the energy emitter.
Regarding claim 20, the limitation “to a first treatment site” is unclear. First, this feature was previously recited in claim 19. Second, it is unclear why energy would be delivered to the first treatment site rather than the second treatment site.
Regarding claim 21, the limitation “formed in the shaft” is unclear. It is unclear which device (i.e., the camera sheath assembly or treatment catheter) the shaft is referring to.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 11-12, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watts (US 2006/0149129).
Regarding claim 1, Watts discloses a camera sheath assembly (figure 1) comprising: an elongate shaft (14, figure 1) having a proximal end and a distal end (see proximal and distal ends of 14, figure 1), and having structure defining a working channel (lumen 22c, figure 3) extending from the proximal end to the distal end (see figure 1); a handle (12, figure 1) coupled to the proximal end of the shaft, the handle being configured to operably couple to a treatment catheter (imaging catheter assembly 28, figure 1 | interpreted the treatment catheter to be functional language); a visualization assembly coupled to the second end of the shaft (LEDs 24 and visual device 26, figure 3), the visualization assembly including at least one camera (visual or imaging device 26, figure 3) and at least one source of light (LEDs 24, figure 3); and at least one pull wire (18, figure 3) configured to direct the distal end in one or a plurality of directions (cables 18…anchored at or near the distal end of the insertion tube 14…[0032]).
Regarding claim 2, Watts further discloses a port (22c, figure 1) configured to be coupled to a handle of the treatment catheter (see 32, figure 1 | the control handle 32 can be coupled or joined together (per the definition by Merriam-Webster) with the port 22c through insertion the shaft 30 into it) to allow access to the working channel within the shaft, which a shaft (30, figure 1) and an ablation assembly (functional language | the treatment catheter can have an ablation assembly) of the treatment catheter are configured to extend within the working channel with the port is coupled to the handle (see figure 1).
Regarding claim 3, Watts further discloses the handle of the camera sheath assembly comprises: an actuation lever (16a-b, figure 1) to assist in the maneuvering of the least one pull wire residing within the working channel of the shaft (see 18 in their own channels of 14, figure 3) to initiate a distal portion of the shaft to flex relative to a proximal portion of the shaft (anchored…distal end…[0032]).
Regarding claim 4, Watts further discloses the actuation lever comprises a thumb or finger activation lever (see 16, figure 1), or a trigger activated by finger pull.
Regarding claim 11, Watts further discloses the handle further comprises a camera/light port (23, figure 1) to signal data received from the visualization assembly to a receiving processor board (electrical lines…imaging components [0034]; electrical communication with a processor [0035]) to generate display imaging data for visualization and navigation to a treatment location.
Regarding claim 12, Watts further discloses the working channel has a diameter of from about 3.9mm to about 6mm (imaging tube 30 has a diameter of less than 4 mm [0036] | the working channel can have a diameter larger than 4 mm).
Regarding claim 15, Watts further discloses the camera sheath and the catheter device can operate as a single steerable catheter device (see figure 1) by which a working end of the treatment catheter is incorporated into the shaft of the assembly (movable imaging tube…[0036]).
Regarding claim 16, Watts further discloses the incorporation of the shaft of the camera sheath assembly and the treatment catheter is configured to have a plurality of cameras for visualizing the proximal (26, figure 3) and distal perspective (figure 4e) of the working end of the treatment catheter.
Regarding claim 17, Watts discloses a method of accessing treatment sites, comprising: coupling the treatment catheter to the camera sheath assembly of claim 1 (see claim 1 rejection above); and steering the treatment catheter to a treatment site via the handle (see 16, figure 1 | [0032]), wherein a shaft of the treatment catheter is contained within the working channel of the shaft (see 30, figure 1), and wherein the length of the catheter providing optimal coupling for visualization and steering ability (see figure 1) during a procedure through which the catheter gains access into the airway with precise positioning (bronchoscopy [0012]).
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) 5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Watts (US 2006/0149129) as applied to claims 1 and 3 above, and further in view of McWeeney (US 2005/0272975).
Regarding claim 5, Watts discloses all of the features in the current invention as shown above in claim 3. Watts is silent regarding the distal portion of the shaft has a flexibility greater than the proximal portion of the shaft.
McWeeney teaches an optical catheter system (8, figure 1 | 708, figure 7). The distal portion (44, figure 10) of the catheter is made more flexible than the remainder of the catheter to allow for steerability of the catheter in vivo ([0080]). The catheter body (38, figure 4) can have a sheath (56, figure 3) with a braided design ([0082]).
It would have been obvious to modify the assembly of Watts to have a more flexible distal portion of the shaft (see 44, figure 1) and a braided sheath ([0082]) as taught by McWeeney. Doing so would allow for steerability of the shaft in vivo ([0080]) and increase the torsional rigidity and column strength of the shaft ([0082]). The modified assembly would have the distal portion of the shaft has a flexibility greater than the proximal portion of the shaft ([0080]; McWeeney).
Regarding claim 7, Watts discloses all of the features in the current invention as shown above in claim 3. Watts is silent regarding the proximal portion has a length greater than a length of the distal portion.
McWeeney teaches an optical catheter system (8, figure 1 | 708, figure 7). The distal portion (44, figure 10) of the catheter is made more flexible than the remainder of the catheter to allow for steerability of the catheter in vivo ([0080]).
It would have been obvious to modify the assembly of Watts to have a more flexible distal portion of the shaft (see 44, figure 1) as taught by McWeeney. Doing so would allow for steerability of the shaft in vivo ([0080]). The modified assembly would have the proximal portion has a length greater than a length of the distal portion (see 42 vs. 44, figure 1; McWeeney).
Regarding claim 8, Watts discloses all of the features in the current invention as shown above in claim 1. Watts is silent regarding the shaft is a coextruded tube comprising multiple lumens.
McWeeney teaches an optical catheter system (8, figure 1 | 708, figure 7). The catheter has a catheter body (38, figure 4) that is formed of a single material using extrusion ([0079]).
It would have been obvious to modify the assembly to have the shaft be made through extrusion as taught by McWeeney ([0079]). Doing so would be a well-known technique in the art to forming a body using a single material ([0079]). The modified assembly would have the shaft is a coextruded tube comprising multiple lumens (see 38, figure 4 | [0079]; McWeeney).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Watts (US 2006/0149129) and McWeeney (US 2005/0272975) as applied to claim 5 above, and further in view of Lopez (US 2023/0120269)
Regarding claim 6, McWeeney further teaches the shaft is formed of a braided jacket (sheath 56…braided [0082]; McWeeney). They are silent regarding a braid angle of the distal portion is less than a braid angle of the proximal portion.
Lopez teaches a tubular rigidizing device (100, figure 18a) with a braid layer (105, figure 18c). A larger braid angle can constrict the diameter ([0092]).
It would have been obvious to modify the assembly of Watts and McWeeney to vary the angle of the braid along the shaft to impact hardness/flexibility ([0092]) as taught by Lopez. Doing so would provide different hardness/flexibility along the shaft ([0092]). The modified assembly would have a braid angle of the distal portion is less than a braid angle of the proximal portion (larger braid angle…constrict the diameter [0092]; Lopez | the modified assembly would have a larger braid angle in the proximal portion to have less flexibility/more constriction).
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Watts (US 2006/0149129) as applied to claim 1 above, and further in view of Marchand (US 2021/0145262).
Regarding claim 9, Watts further discloses the shaft further comprises: a plurality of air channels (accessory outlet 23…air channels…[0034] | lumens…inject fluids [0033], where fluid can be air) for distribution of air into the treatment locations. Watt is silent regarding a distal cap which allows for assembly and attachment of a plurality of pull wires.
Marchand teaches an instrument port (20, figure 2) with a handle (200, figure 2), an elongated shaft (210, figure 2), a bendable shaft (220, figure 2), and a steerable tip (230, figures 2 and 16). The first and second wires (1401-1402, figure 14) are welded to the distal end of the bendable shaft ([0109]).
It would have been obvious to modify the assembly with a steerable tip (230, figure 4) with wires welded to it ([0109] | see figures 14 and 16) as taught by Marchand. Doing so would provide a tip that is steerable and has a customizable angle or orientation with respect to the shaft axis ([0080]). The modified assembly would have a distal cap (230, figures 14 and 16) which allows for assembly and attachment of a plurality of pull wires (see 1401-1402, figures 14 and 16 | interpreted the wires to be welded to the steerable tip, as seen with the dashed lines in figure 16).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Watts (US 2006/0149129) and Marchand (US 2021/0145262) as applied to claim 9 above, and further in view of Kaiser (US 2021/0259790).
Regarding claim 10, Watts and Marchand disclose all of the features in the current invention as shown above in claim 9. They are silent regarding the pull wires are attached to the distal cap via laser welding or brazing.
Kaiser teaches control wires (110, figure 2a) that are fixedly attached to anchor members (109, figure 2a) by laser welding ([0058]).
It would have been obvious to modify the assembly to fix the pull wires to the distal cap using laser welding as taught by Kaiser ([0058]). Doing so is a method to fixedly attach a control wire ([0058]). The modified assembly would have the pull wires are attached to the distal cap via laser welding (laser welding [0058]; Kaiser) or brazing.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Watts (US 2006/0149129) as applied to claim 1 above, and further in view of Lucchina (US 2022/0152329).
Regarding claim 13, Watts discloses all of the features in the current invention as shown above in claim 1. Watts is silent regarding the shaft further comprises grooves defined on an outer surface thereof, the grooves being configured to allow for ventilation around the sheath during an intubated procedure.
Lucchina teaches an intubation bougie (10, figure 3) with a body (11, figure 3). The body has longitudinal grooves (110, figure 3) that enable a passage of fluid to be provided within the body, so as to allow ventilation of the patient during intubation ([0145]).
It would have been obvious to modify the assembly of Watts with the longitudinal grooves (110, figure 3) as taught by Lucchina. Doing so would allow ventilation of the patient during intubation ([0145]). The modified assembly would have the shaft further comprises grooves (110, figure 3; Lucchina) defined on an outer surface thereof (see figure 3), the grooves being configured to allow for ventilation around the sheath during an intubated procedure ([0145]).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Watts (US 2006/0149129) as applied to claim 1 above, and further in view of Miyake (US 2024/0023803).
Regarding claim 14, Watts discloses all of the features in the current invention as shown above in claim 1. Watts is silent regarding the camera sheath assembly is configured to suction a lumen of a subject when the working channel does not house the treatment catheter.
Miyake teaches a bronchoscope (50, figure 1) with a balloon catheter (20, figure 1) inserted through the second lumen (2, figure 2) of the sheath (5, figures 1-2). Negative pressure can be applied to the second lumen ([0087]). The proximal end of the second lumen is coupled to the negative pressure generator attachment port (51, figure 1) at the operation portion (55, figure 1).
It would have been obvious to modify the assembly of Watts to have a negative pressure generator attachment port (51, figure 1) to connect to the working channel ([0112]) as taught by Miyake. Doing so would provide a sticking force of the working channel ([0113]). The modified assembly would have the camera sheath assembly is configured to suction a lumen of a subject when the working channel does not house the treatment catheter (negative pressure applied to the second lumen [0087]; Miyake | negative pressure can be applied when the treatment catheter is not inserted in the working channel).
Claim(s) 2 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Watts (US 2006/0149129) as applied to claims 1 and 17 above, and further in view of Palushi (US 2022/0087739).
Regarding claim 2, Watt further discloses a port (22c, figure 1) configured to be coupled to a handle of the treatment catheter (see 32, figure 1 | the control handle 32 can be coupled or joined together (per the definition by Merriam-Webster) with the port 22c through insertion the shaft 30 into it) to allow access to the working channel within the shaft, which a shaft (30, figure 1) of the treatment catheter are configured to extend within the working channel with the port is coupled to the handle (see figure 1). Watts is silent regarding an ablation assembly of the treatment catheter are configured to extend within the working channel.
Palushi teaches an expandable ablation catheter (314, figure 7a) with electrode assemblies (350, figure 7a) and a camera (364, figure 7a) inserted through a sheath (112, figure 7a).
It would have been obvious to modify the treatment catheter with an inflatable ballon (342, figure 7a) and electrode assemblies (350, figure 7a) as taught by Palushi. Doing so would provide an expandable ablation member to facilitate RF ablation ([0037]). The modified assembly would have an ablation assembly (see 314, figure 7a; Palushi) of the treatment catheter are configured to extend within the working channel (see tube lumen 126, figure 7a)
Regarding claim 18, Watts discloses all of the features in the current invention as shown above in claim 17. Watts is silent regarding a working end of the shaft of the treatment catheter comprises an expandable member having at least one energy emitter positioned thereon, the method further comprising: advancing the expandable member in a retracted state through the working channel and the distal end of the shaft; and expanding the expandable member to an expanded state, wherein the expandable member and a position thereof is viewable on a display screen operably connected to the visualization assembly.
Palushi teaches an expandable ablation catheter (314, figure 7a) with electrode assemblies (350, figure 7a) and a camera (364, figure 7a) inserted through a sheath (112, figure 7a).
It would have been obvious to modify the method to have the treatment catheter with an inflatable ballon (342, figure 7a) and electrode assemblies (350, figure 7a) as taught by Palushi. Doing so would provide an expandable ablation member to facilitate RF ablation ([0037]). The modified method would comprise wherein a working end of the shaft of the treatment catheter comprises an expandable member (342, figure 7a; Palushi) having at least one energy emitter (350, figure 7a) positioned thereon, the method further comprising: advancing the expandable member in a retracted state through the working channel and the distal end of the shaft (best seen figures 5); and expanding the expandable member to an expanded state (best seen with figure 5c), wherein the expandable member and a position thereof is viewable on a display screen operably connected to the visualization assembly (electrical lines…imaging components [0034]; electrical communication with a processor and/or monitor [0035]; Watts).
Regarding claim 19, Palushi further teaches delivering energy to from the at least one energy emitter of the expandable member to a first treatment site to treat a condition of the airway (150, figure 7a; Palushi).
Regarding claim 20, Palushi further teaches moving the at least one energy emitter to a second treatment site while displaying the same on the display screen (steering of sheath [0040] Palushi); and delivering energy to from the at least one energy emitter of the expandable member to a first treatment site to treat a condition of the airway (150, figure 7a; Palushi).
Regarding claim 21, Watts and Palushi further disclose providing air to the airway via airway channels formed in the shaft (accessory outlet 23…air channels…[0034] | lumens…inject fluids [0033], where fluid can be air; Watts) while delivering energy to the treatment site (150, figure 7a; Palushi).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Reydel (US 2015/0119640) discloses an endoscope with a balloon access device; Takase (US 2002/0019582) discloses changes the braid angle to affect hardness of a flexible tube ([0062]).
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
June 12, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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