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 .
Information Disclosure Statement
The information disclosure statement filed 10/02/2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because a separate section for citations of U.S. patents and U.S. patent application publications was not provided. Instead, U.S. patent applications were labeled under “US PATENT REFERENCES”. Further, copies of each cited foreign patent document and non-patent literature publication were not provided. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statements (IDS) submitted on 08/26/2025 and 02/20/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The number of drawings has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the drawings.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: 138, 138a, 139, 139a.
The drawings are objected to because for each of the lumens of the catheter adapter 120, reference numbers 131-140, there is a corresponding lumen of the catheter 90, references numbers 131a-140a. The examiner understands the difference between the reference numbers is in regard to being located on the catheter adapter 120 versus the catheter 90. However, FIG. 9 shows the lumens of the catheter adapter 120 sharing the same lumens of the catheter 90. The examiner finds it redundant to name the same lumens under two separate reference numbers, especially since FIG. 9 shows the two parts sharing a cohesive lumen. The examiner suggests using the same reference number for the lumens on both the catheter adapter 120 and catheter 90 for continuity purposes.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
Specification
The disclosure is objected to because of the following informalities: Paragraphs [0069]-[0079] discuss for each of the lumens of the catheter adapter 120, reference numbers 131-140, there is a corresponding lumen of the catheter 90, references numbers 131a-140a. The examiner understands the difference between the reference numbers is in regard to being located on the catheter adapter 120 versus the catheter 90. However, FIG. 9 shows the lumens of the catheter adapter 120 sharing the same lumens of the catheter 90. The examiner finds it redundant to name the same lumens under two separate reference numbers, especially since FIG. 9 shows the two parts sharing a cohesive lumen. The examiner suggests using the same reference number for the lumens on both the catheter adapter 120 and catheter 90 for continuity purposes.
Appropriate correction is required.
Claim Objections
Claims 1, 8, and 15 are objected to because of the following informalities: In the first line of each of the claims, the claims state “A system suitable for delivering a therapeutic agent to a target site”. The words “suitable” is a broad term that does not clearly define the ability of the system to deliver a therapeutic agent to a target site. The examiner suggests removing the term “suitable” to be exact in what the applicant intends to claim. Appropriate correction is required. For the purposes of examination, the examiner will interpret the claim to mean the claimed system has the ability to deliver a therapeutic agent to a target site, but other systems could work to complete the same task as well.
Claim 1 is objected to because of the following informalities: In the eleventh line of the claim, the claim states “a light transmitting component”. This language is broad and not exact to what type of light transmitting component is intended to be claimed by the applicant. The examiner suggests modifying “a light transmitting component” to add specificity to the claim. Appropriate correction is required. For the purposes of examination, the examiner will interpret the claim language to mean any kind of light transmitting element.
Claim 17 is objected to because of the following informalities: The claim uses the language “a non-parallel angle” to describe the relationship between the distal segment of the aspiration lumen and the distal segment of the therapeutic agent lumen. The language “non-parallel” is broad and unclear, and confuses the examiner as to what angle of the distal segment of the aspiration lumen is at the non-parallel angle “relative to” the distal segment of the therapeutic agent lumen. FIG. 15 shows the distal region 131a’ of the therapeutic agent lumen and the distal region 132a’ of the aspiration lumen. Although the distal regions are curved, the distal regions of the lumens could still be interpreted as parallel. The examiner suggests modifying the language “non-parallel” to a more specific term in order to clarify what angle is being referred to and the lumens’ positioning.
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, 8, 14, and 15 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, in the ninth line of the claim, the claim states “a camera head coupled to the camera lumen”. It is unclear to the examiner in what manner the camera head is coupled to the camera lumen. FIG. 15 shows the camera head located within the camera lumen, but there does not appear to be any direct attachment. Using the term “coupled” without providing any context in the drawings or specification as to what is meant by the term renders the claim indefinite. The examiner suggests modifying the language of claim 1 to be more specific as to the way in which the camera head is positioned within the camera lumen. For the purposes of examination, the examiner will interpret “coupled” to mean the camera head is located within the camera lumen.
Regarding claim 1, in the eleventh line of the claim, the claim states “a light transmitting component coupled to the light transmitting lumen”. It is unclear to the examiner in what manner the light transmitting component is coupled to the light transmitting lumen. Further, none of the figures depict the claimed coupling, and the specification does not provide any more details than of what is claimed. Using the term “coupled” without providing any context in the drawings or specification as to what is meant by the term renders the claim indefinite. The examiner suggests modifying the language of claim 1 to be more specific as to the way in which the light transmitting component is positioned within the light transmitting lumen. For the purposes of examination, the examiner will interpret “coupled” to mean the light transmitting component is located within the light transmitting lumen.
Regarding claim 8, in the ninth line of the claim, the claim states “a camera head coupled to the camera lumen”. It is unclear to the examiner in what manner the camera head is coupled to the camera lumen. FIG. 15 shows the camera head located within the camera lumen, but there does not appear to be any direct attachment. Using the term “coupled” without providing any context in the drawings or specification as to what is meant by the term renders the claim indefinite. The examiner suggests modifying the language of claim 8 to be more specific as to the way in which the camera head is positioned within the camera lumen. For the purposes of examination, the examiner will interpret “coupled” to mean the camera head is located within the camera lumen.
Regarding claims 14 and 20, the claims state “an aspiration fluid”. The claims are rendered indefinite as the process of aspiration typically removes an excess of fluid, but claims 14 and 20 appear to claim an aspiration fluid to flow via an aspiration lumen. The specification further adds confusion as paragraph [00114] states the aspiration fluid flows towards the catheter. It is confusing to the examiner how a process that typically removes fluid away from a target site is providing its own fluid towards the target site. The examiner suggests modifying the language of “aspiration fluid” to be more specific as to what is intended to be “aspiration fluid”. For the purposes of examination, the examiner will interpret “aspiration fluid” to be negative pressure created by a vacuum, as is done in typical aspiration procedures.
Regarding claim 15, in the ninth line of the claim, the claim states “a camera head coupled to the camera lumen”. It is unclear to the examiner in what manner the camera head is coupled to the camera lumen. FIG. 15 shows the camera head located within the camera lumen, but there does not appear to be any direct attachment. Using the term “coupled” without providing any context in the drawings or specification as to what is meant by the term renders the claim indefinite. The examiner suggests modifying the language of claim 15 to be more specific as to the way in which the camera head is positioned within the camera lumen. For the purposes of examination, the examiner will interpret “coupled” to mean the camera head is located within the camera lumen.
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.
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.
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.
Claims 1-3, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Gittard (United States Patent Application Publication No. US 2018/0099088 A1), and further in view of Benning et al. (United States Patent Application Publication No. US 2012/0041267 A1; herein, Benning) and Sanders et al. (United States Patent Application Publication No. US 2009/0209826 A1; herein, Sanders).
Regarding claim 1, Gittard discloses a system (system 20) suitable for delivering a therapeutic agent to a target site ([0025], "a system suitable for delivering one or more therapeutic agents"), the system comprising: a container for holding the therapeutic agent ([0025], "a container 30 that is configured to hold a therapeutic agent 38"); a housing configured to securely retain the container ([0026], "a housing 22, which is suitable for securely holding, engaging and/or covering the container 30"); a pressure source (pressure source 68) having pressurized fluid ([0036], "the pressure source 68 may comprise a pressurized fluid"), the pressure source in selective fluid communication with at least a portion of the container ([0025], "at least one pressure source 68 that is configured to be placed in selective fluid communication with at least a portion of the container 30"); a catheter (catheter 90) including a therapeutic agent lumen in fluid communication with the container (FIG. 2, [0042], "The fluid and the therapeutic agent 38 then exit through the first end 51 of the outlet tube 50, through the outlet port 62 of the cap 60, and through the catheter 90, thereby delivering the therapeutic agent 38 to the target site at a desired pressure." The outlet tube 50 and cap 60 are components of container 30.).
Gittard does not disclose a camera lumen, and a light transmitting lumen; a camera including a camera head coupled to the camera lumen of the catheter; and a light transmitting component coupled to the light transmitting lumen of the catheter.
However, Benning teaches a camera lumen (Fig. 2A, lumen of imaging device 36), and a light transmitting lumen (Fig. 2A, lumen of illumination device 38); a camera (imaging device 36); and a light transmitting component (illumination device 38) coupled to the light transmitting lumen of the catheter (Fig. 2B, illumination device 38 components are situated within the lumen of illumination device 38). Therefore, 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 catheter disclosed by Gittard to include various lumens as well as a camera and light transmitting component as taught by Benning in order to transmit an image signal of a work site to a monitor or other display device positioned outside the body and viewable by the surgeon ([0026]), the work site being illuminated for better viewing in the image by the light transmitting component ([0027]).
Gittard in view of Benning still does not explicitly disclose a camera head coupled to the camera lumen of the catheter.
However, Sanders teaches a camera head (FIG. 3, camera 122) coupled to the camera lumen of the catheter (FIG. 3, camera 122 is within tip 112 of tube 110). Therefore, 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 camera taught by Benning of the modified catheter disclosed by Gittard to include a camera head within a camera lumen as taught by Sanders in order to guide insertion of a catheter within a patient ([0011]).
Regarding claim 2, in the modified system of Gittard, Gittard does not disclose a camera container coupled to the housing, wherein the camera includes a camera cord coupled to the camera head, and wherein at least a portion of the camera cord extends from the camera container and through at least a portion of the camera lumen of the catheter.
However, Sanders teaches a camera container (printed circuit board “PCB” 208) coupled to the housing (FIG. 2, PCB 208 is disposed inside and connected to housing 210), wherein the camera includes a camera cord (power/video wire 314) coupled to the camera head (FIG. 3, camera 122 are configured to receive power via the power/video wire 314), and wherein at least a portion of the camera cord extends from the camera container and through at least a portion of the camera lumen of the catheter (FIG. 2 and FIG. 3, [0048], “the power/video wire 314 can be configured to stretch through the wire bundle 108 and connect to the PCB 208”). Therefore, 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 camera taught by Benning of the modified catheter disclosed by Gittard to include a camera container and camera cord which extends from the camera container through the catheter as taught by Sanders in order to process and transmit images from an activated camera to the camera container ([0048]).
Regarding claim 3, in the modified system of Gittard, Gittard does not disclose the light transmitting component includes a LED coupled to a wire, and wherein at least a portion of the wire extends from the camera container and through at least a portion of the light transmitting lumen.
However, Benning teaches the light transmitting component includes a LED coupled to a wire, and wherein at least a portion of the wire extends from the camera container and through at least a portion of the light transmitting lumen (Fig, 2B, [0034], "LEDs may be used as illumination device 38". Illumination device is connected by cords and wires through lumen.). Therefore, 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 light transmitting component previously taught by Benning of the modified system of Gittard to be an LED with wires extending through the light transmitting lumen as taught by Benning in order that the device have the capability to control a characteristic of the light emitted by each individual LED ([0034]). LEDs are also known in the art to be durable and safe when inserted into the body.
Regarding claim 6, in the modified system of Gittard, Gittard does not disclose the catheter further includes an aspiration lumen configured to permit suction in a distal to proximal direction from the target site towards the housing.
However, Benning teaches the catheter further includes an aspiration lumen (Fig. 2A, aspiration lumen 34b) configured to permit suction in a distal to proximal direction from the target site towards the housing ([0024], "Suction may then be applied at proximal end 28 of aspiration lumen 34b to remove the fluid (and/or biological material) from work site 18 through the aspiration lumen"). Therefore, 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 modified catheter disclosed by Gittard to include an aspiration lumen that permits suction as taught by Benning in order to keep the target site free from fluid and biological material when performing therapy at the specific site ([0023]-[0024]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gittard in view of Benning and Sanders as applied to claim 1 above, and further in view of Furlong et al. (United States Patent Application Publication No. US 2015/0031951 A1; herein, Furlong).
Regarding claim 4, in the modified system of Gittard, Gittard does not disclose a reservoir for holding an irrigation fluid, wherein the catheter further includes an irrigation lumen, and the irrigation lumen allows the irrigation fluid to clean the camera via the irrigation lumen.
However, Furlong teaches a reservoir for holding an irrigation fluid (FIG. 15, [0253], irrigation source 1532 contains fluid that can flow into the endoscope 100). Therefore, 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 modified system disclosed by Gittard to include an irrigation fluid reservoir as taught by Furlong in order to contain an irrigation fluid so it can be released in a controlled manner ([0253]).
Further, Benning teaches the catheter further includes an irrigation lumen (Fig. 2A irrigation lumen 34a), and the irrigation lumen allows the irrigation fluid to clean the camera via the irrigation lumen ([0024], "fluid may be directed from proximal end 28 to distal end 22 through irrigation lumen 34a to clean work site 18"). Therefore, 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 modified catheter disclosed by Gittard to include an irrigation lumen which allows passage of an irrigation fluid as taught by Benning in order to keep the target site clean for visualization ([0023]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gittard in view of Benning, Sanders, and Furlong as applied to claim 4 above, and further in view of Tan (United States Patent Application Publication No. US 2019/0015576 A1).
Regarding claim 5, in the modified system of Gittard, Gittard does not disclose a valve assembly that routes the pressurized fluid and supplies pressure for irrigation via the irrigation lumen of the catheter, for insufflation via the therapeutic agent lumen of the catheter, and for therapeutic agent delivery via the therapeutic agent lumen of the catheter.
However, Tan teaches a valve assembly that routes the pressurized fluid and supplies pressure for irrigation via the irrigation lumen of the catheter, for insufflation via the therapeutic agent lumen of the catheter, and for therapeutic agent delivery via the therapeutic agent lumen of the catheter ([0061], [0074]-[0076], Valve assembly includes first valve 131, second valve 132, and third valve 133. The plurality of valves 131, 132, 133 are attached individually to a plurality of catheters 10, 20, 30 which can be used for suctioning or injecting infusions and for expelling or suctioning waste fluids. By controlling infusions and suctioning, it would be commonly understood the valves and catheters are completing the same actions as the valve assembly in terms of irrigation, insufflation, and therapeutic agent delivery.). Therefore, 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 modified system disclosed by Gittard to include a valve assembly with the ability to route fluid and pressure for irrigation, insufflation, and therapeutic agent delivery as taught by Tan in order to precisely quantify the injection amount of therapeutic agents and suction amount of waste fluids, as well as to inject therapeutic agents in a slow but continuous and stable manner ([0003]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Gittard in view of Benning and Sanders as applied to claim 1 above, and further in view of Simmons et al. (WO 2018/022402 A1; herein, Simmons).
Regarding claim 7, in the modified system of Gittard, Gittard does not disclose at least one deflection wire having a proximal region and a distal region, wherein the catheter further includes at least one deflection wire lumen, and wherein the distal region of the at least one deflection wire extends through at least a portion of the at least one deflection wire lumen of the catheter to provide an ability to maneuver a distal region of the catheter.
However, Simmons teaches at least one deflection wire having a proximal region and a distal region (FIG. 4A, [0032] control wire 118 connects from outer spool at the proximal region to a distal catheter portion at the distal region), wherein the catheter further includes at least one deflection wire lumen ([0038], second control wire lumen 168 receives control wire 118), and wherein the distal region of the at least one deflection wire extends through at least a portion of the at least one deflection wire lumen of the catheter to provide an ability to maneuver a distal region of the catheter ([0034], control wires play a role in operation of steering/deflection of the distal catheter portion). Therefore, 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 modified system disclosed by Gittard to include at least one deflection wire with at least one deflection wire lumen for maneuverability of the distal region of the catheter as taught by Simmons as wire-tensioning is commonly known in the art as a reliable way to provide predictable and desirable steering behavior for a steerable catheter ([0005]).
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gittard, and further in view of Benning, Simmons, and Sanders.
Regarding claim 8, Gittard discloses a system (system 20) suitable for delivering a therapeutic agent to a target site ([0025], "a system suitable for delivering one or more therapeutic agents"), the system comprising: a container for holding the therapeutic agent ([0025], "a container 30 that is configured to hold a therapeutic agent 38"); a housing configured to securely retain the container ([0026], "a housing 22, which is suitable for securely holding, engaging and/or covering the container 30"); a pressure source (pressure source 68) having pressurized fluid ([0036], "the pressure source 68 may comprise a pressurized fluid"), the pressure source in selective fluid communication with at least a portion of the container ([0025], "at least one pressure source 68 that is configured to be placed in selective fluid communication with at least a portion of the container 30"); a catheter (catheter 90) including a therapeutic agent lumen in fluid communication with the container (FIG. 2, [0042], "The fluid and the therapeutic agent 38 then exit through the first end 51 of the outlet tube 50, through the outlet port 62 of the cap 60, and through the catheter 90, thereby delivering the therapeutic agent 38 to the target site at a desired pressure." The outlet tube 50 and cap 60 are components of container 30.).
Gittard does not disclose a camera lumen, and at least one deflection wire lumen; a camera including a camera head coupled to the camera lumen of the catheter; and at least one deflection wire having a proximal region and a distal region, wherein the distal region of the at least one deflection wire extends through at least a portion of the at least one deflection wire lumen of the catheter to provide an ability to maneuver a distal region of the catheter.
However, Benning teaches a camera lumen (Fig. 2A, lumen of imaging device 36), and a camera (imaging device 36). Therefore, 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 catheter disclosed by Gittard to include a camera and lumen for the camera as taught by Benning in order to transmit an image signal of a work site to a monitor or other display device positioned outside the body and viewable by the surgeon ([0026]).
Gittard in view of Benning still does not explicitly disclose at least one deflection wire lumen; a camera head coupled to the camera lumen of the catheter; and at least one deflection wire having a proximal region and a distal region, wherein the distal region of the at least one deflection wire extends through at least a portion of the at least one deflection wire lumen of the catheter to provide an ability to maneuver a distal region of the catheter.
However, Sanders teaches a camera head (FIG. 3, camera 122) coupled to the camera lumen of the catheter (FIG. 3, camera 122 is within tip 112 of tube 110). Therefore, 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 camera taught by Benning of the modified catheter disclosed by Gittard to include a camera head within a camera lumen as taught by Sanders in order to guide insertion of a catheter within a patient ([0011]).
Gittard in view of Benning and Sanders still does not disclose at least one deflection wire lumen; and at least one deflection wire having a proximal region and a distal region, wherein the distal region of the at least one deflection wire extends through at least a portion of the at least one deflection wire lumen of the catheter to provide an ability to maneuver a distal region of the catheter.
However, Simmons teaches at least one deflection wire lumen (control wire lumens 166, 168, 176, 178); and at least one deflection wire having a proximal region and a distal region (FIG. 4A, [0032] control wire 118 connects from outer spool at the proximal region to a distal catheter portion at the distal region), wherein the distal region of the at least one deflection wire extends through at least a portion of the at least one deflection wire lumen of the catheter ([0038] second control wire lumen 168 receives control wire 118) to provide an ability to maneuver a distal region of the catheter ([0034] control wires play a role in operation of steering/deflection of the distal catheter portion). Therefore, 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 modified system disclosed by Gittard to include at least one deflection wire with at least one deflection wire lumen for maneuverability of the distal region of the catheter as taught by Simmons as wire-tensioning is commonly known in the art as a reliable way to provide predictable and desirable steering behavior for a steerable catheter ([0005]).
Regarding claim 9, in the modified system of Gittard, Gittard does not disclose at least one deflection actuator, wherein the proximal region of the at least one deflection wire is coupled to the at least one deflection actuator, such that the distal region of the catheter can be maneuvered upon actuation of the at least one deflection actuator.
However, Simmons teaches at least one deflection actuator (outer control wheel 110), wherein the proximal region of the at least one deflection wire is coupled to the at least one deflection actuator (FIG. 2, [0025], "The outer control wheel 110 engages a shaft 114 of, and controls rotation of, an outer spool 112", and second control wire 118 is directly connected to outer spool 112), such that the distal region of the catheter can be maneuvered upon actuation of the at least one deflection actuator ([0031], "each of the control wires 116, 118, 136, 138 is directed a maximal distance around the spool to which it is engaged, which those of skill in the art will understand to provide a more desirable range of mechanical movement for/of the control wires with regard to controlled deflection of the catheter distal end."). Therefore, 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 modified system disclosed by Gittard to include at least one deflection actuator connected to the at least one deflection wire for maneuverability of the distal region as taught by Simmons in order that tension, which is the driving force steerability of the device, may be applied by a user to the deflection wire at the location of the deflection actuator ([0020]).
Regarding claim 10, in the modified system of Gittard, Gittard does not disclose the at least one deflection wire includes a first deflection wire, a second deflection wire, a third deflection wire, and a fourth deflection wire, and the at least one deflection actuator includes a first deflection actuator and a second deflection actuator, wherein the first deflection actuator is coupled to the first deflection wire and the second deflection wire to enable movement of the catheter in a first direction and a second direction based on which direction the first deflection actuator is rotated, and wherein the second deflection actuator is coupled to the third deflection wire and the fourth deflection wire to enable movement of the catheter in a third direction and a fourth direction based on which direction the second deflection actuator is rotated.
However, Simmons teaches the at least one deflection wire includes a first deflection wire, a second deflection wire, a third deflection wire, and a fourth deflection wire (FIG. 4A, control wires 116, 118, 136, 138), and the at least one deflection actuator includes a first deflection actuator and a second deflection actuator (FIG. 1, outer control wheel 110 and inner control wheel 130), wherein the first deflection actuator is coupled to the first deflection wire and the second deflection wire to enable movement of the catheter in a first direction and a second direction based on which direction the first deflection actuator is rotated ([0024], "the outer control wheel 110 is disposed in mechanical communication with a pair of control wires that are operable, upon wheel rotation, to deflect the catheter body 104 along a first plane"; [0025], outer control wheel 110 is coupled to first and second control wire 116, 118), and wherein the second deflection actuator is coupled to the third deflection wire and the fourth deflection wire to enable movement of the catheter in a third direction and a fourth direction based on which direction the second deflection actuator is rotated ([0024], "the inner control wheel 130 is disposed in mechanical communication with another pair of control wires that are operable, upon wheel rotation, to deflect the catheter body 104 along a second plane that may be generally orthogonal to the first plane"; [0025], inner control wheel 130 is coupled to third and fourth control wires 136, 138). Therefore, 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 at least one deflection wire and actuator as previously taught by Simmons of modified system disclosed by Gittard to be defined as four deflection wires and two deflection actuators, each actuator controlling two wires as taught by Simmons in order to deflect the distal end portion of the catheter in any direction around a 360-degree circle by simultaneous or sequential operation of the two deflection actuators ([0024]).
Regarding claim 11, in the modified system of Gittard, Gittard does not disclose the at least one deflection wire lumen includes four deflection wire lumens, and wherein each of the four deflection wire lumens receive one respective deflection wire.
However, Simmons teaches the at least one deflection wire lumen includes four deflection wire lumens (FIG. 8, control wire lumens 166, 168, 176, 178), and wherein each of the four deflection wire lumens receive one respective deflection wire ([0038], "The first and second control wire lumens 166, 168 may receive the paired opposite control wires 116, 118...The third and fourth control wire lumens 176, 178 may receive the paired opposite control wires 136, 138"). Therefore, 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 at least one deflection wire lumen as previously taught by Simmons of modified system disclosed by Gittard to be defined as four deflection wire lumens, each receiving one respective wire as taught by Simmons in order protect the wires so they are free to move longitudinally ([0039]) and to support in deflecting the distal end portion of the catheter in any direction around a 360-degree circle ([0024]).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Gittard in view of Benning, Simmons, and Sanders as applied to claim 8 above, and further in view of Furlong.
Regarding claim 12, in the modified system of Gittard, Gittard does not disclose a reservoir for holding an irrigation fluid, wherein the catheter further includes an irrigation lumen, and the irrigation lumen allows the irrigation fluid to clean the camera via the irrigation lumen.
However, Furlong teaches a reservoir for holding an irrigation fluid (FIG. 15, [0253], irrigation source 1532 contains fluid that can flow into the endoscope 100). Therefore, 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 modified system disclosed by Gittard to include an irrigation fluid reservoir as taught by Furlong in order to contain an irrigation fluid so it can be released in a controlled manner ([0253]).
Further, Benning teaches the catheter further includes an irrigation lumen (Fig. 2A irrigation lumen 34a), and the irrigation lumen allows the irrigation fluid to clean the camera via the irrigation lumen ([0024], "fluid may be directed from proximal end 28 to distal end 22 through irrigation lumen 34a to clean work site 18"). Therefore, 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 modified catheter disclosed by Gittard to include an irrigation lumen which allows passage of an irrigation fluid as taught by Benning in order to keep the target site clean for visualization ([0023]).
Regarding claim 13, in the modified system of Gittard, Gittard does not disclose the catheter further includes an aspiration lumen configured to permit suction in a distal to proximal direction from the target site towards the housing. However, Benning teaches the catheter further includes an aspiration lumen (Fig. 2A, aspiration lumen 34b) configured to permit suction in a distal to proximal direction from the target site towards the housing ([0024], "Suction may then be applied at proximal end 28 of aspiration lumen 34b to remove the fluid (and/or biological material) from work site 18 through the aspiration lumen"). Therefore, 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 modified catheter disclosed by Gittard to include an aspiration lumen that permits suction as taught by Benning in order to keep the target site free from fluid and biological material when performing therapy at the specific site ([0023]-[0024]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Gittard in view of Benning, Simmons, Sanders, and Furlong as applied to claim 13 above, and further in view of Tan.
Regarding claim 14, in the modified system of Gittard, Gittard does not disclose a first valve configured for selectively permitting flow of an insufflation fluid via the therapeutic agent lumen of the catheter, a second valve configured for selectively permitting flow of the irrigation fluid via the irrigation lumen of the catheter, and a third valve configured for selectively permitting flow of an aspiration fluid via the aspiration lumen of the catheter.
However, Tan teaches a first valve (first valve 131) configured for selectively permitting flow of an insufflation fluid via the therapeutic agent lumen of the catheter ([0074], first valve 131 permits flow of a dialysate through a dialysate catheter by way of negative pressure), a second valve (second valve 132) configured for selectively permitting flow of the irrigation fluid via the irrigation lumen of the catheter ([0075], second valve 132 permits flow of dialysate through an injection catheter), and a third valve (third valve 133) configured for selectively permitting flow of an aspiration fluid via the aspiration lumen of the catheter ([0076], third valve 133 permits drainage of waste through a waste fluid catheter). valve assembly in terms of irrigation, insufflation, and therapeutic agent delivery.). Therefore, 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 modified system disclosed by Gittard to include a three-valve assembly with the ability to selectively permit the flow of fluids as taught by Tan in order to precisely quantify the injection amount of therapeutic agents and suction amount of waste fluids, as well as to inject therapeutic agents in a slow but continuous and stable manner ([0003]).
Claims 15-16, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gittard, and further in view of Benning, Sanders, and Tan.
Regarding claim 15, Gittard discloses a system (system 20) suitable for delivering a therapeutic agent to a target site ([0025], "a system suitable for delivering one or more therapeutic agents"), the system comprising: a container for holding the therapeutic agent ([0025], "a container 30 that is configured to hold a therapeutic agent 38"); a housing configured to securely retain the container ([0026], "a housing 22, which is suitable for securely holding, engaging and/or covering the container 30"); a pressure source (pressure source 68) having pressurized fluid ([0036], "the pressure source 68 may comprise a pressurized fluid"), the pressure source in selective fluid communication with at least a portion of the container ([0025], "at least one pressure source 68 that is configured to be placed in selective fluid communication with at least a portion of the container 30"); a catheter (catheter 90) including a therapeutic agent lumen in fluid communication with the container (FIG. 2, [0042], "The fluid and the therapeutic agent 38 then exit through the first end 51 of the outlet tube 50, through the outlet port 62 of the cap 60, and through the catheter 90, thereby delivering the therapeutic agent 38 to the target site at a desired pressure." The outlet tube 50 and cap 60 are components of container 30.).
Gittard does not disclose a camera lumen; a camera including a camera head coupled to the camera lumen of the catheter; and a valve assembly that routes the pressurized fluid and supplies pressure for insufflation via the therapeutic agent lumen of the catheter, and for therapeutic agent delivery via the therapeutic agent lumen of the catheter.
However, Benning teaches a camera lumen (Fig. 2A, lumen of imaging device 36), and a camera (imaging device 36). Therefore, 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 catheter disclosed by Gittard to include a camera and lumen for the camera as taught by Benning in order to transmit an image signal of a work site to a monitor or other display device positioned outside the body and viewable by the surgeon ([0026]).
Gittard in view of Benning still does not disclose a camera head coupled to the camera lumen of the catheter; and a valve assembly that routes the pressurized fluid and supplies pressure for insufflation via the therapeutic agent lumen of the catheter, and for therapeutic agent delivery via the therapeutic agent lumen of the catheter.
However, Sanders teaches a camera head (FIG. 3, camera 122) coupled to the camera lumen of the catheter (FIG. 3, camera 122 is within tip 112 of tube 110). Therefore, 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 camera taught by Benning of the modified catheter disclosed by Gittard to include a camera head within a camera lumen as taught by Sanders in order to guide insertion of a catheter within a patient ([0011]).
Gittard in view of Benning and Sanders still does not disclose a valve assembly that routes the pressurized fluid and supplies pressure for insufflation via the therapeutic agent lumen of the catheter, and for therapeutic agent delivery via the therapeutic agent lumen of the catheter.
However, Tan teaches a valve assembly that routes the pressurized fluid and supplies pressure for insufflation via the therapeutic agent lumen of the catheter, and for therapeutic agent delivery via the therapeutic agent lumen of the catheter. ([0061], [0074]-[0076], Valve assembly includes first valve 131, second valve 132, and third valve 133. The plurality of valves 131, 132, 133 are attached individually to a plurality of catheters 10, 20, 30 which can be used for suctioning or injecting infusions and for expelling or suctioning waste fluids. By controlling infusions and suctioning, it would be commonly understood the valves and catheters are completing the same actions as the valve assembly in terms of insufflation and therapeutic agent delivery.). Therefore, 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 modified system disclosed by Gittard to include a valve assembly with the ability to route fluid and pressure for insufflation and therapeutic agent delivery as taught by Tan in order to precisely quantify the injection amount of therapeutic agents and suction amount of waste fluids, as well as to inject therapeutic agents in a slow but continuous and stable manner ([0003]).
Regarding claim 16, in the modified system of Gittard, Gittard does not disclose the catheter further includes an irrigation lumen, wherein the camera provides a visual image of the target site during delivery of the therapeutic agent, and wherein the irrigation lumen allows an irrigation fluid to clean the camera via the irrigation lumen. However, Benning teaches the catheter further includes an irrigation lumen (Fig. 2A, irrigation lumen 34a), wherein the camera provides a visual image of the target site during delivery of the therapeutic agent ([0026], "Imaging device 36 may transmit an image signal to a monitor or other display device 42 positioned outside the body and viewable by the surgeon." Image signal is interpreted by the examiner as any location within the body, which includes a target site.), and wherein the irrigation lumen allows an irrigation fluid to clean the camera via the irrigation lumen ([0024], "fluid may be directed from proximal end 28 to distal end 22 through irrigation lumen 34a to clean work site 18"). Therefore, 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 modified catheter disclosed by Gittard to include an irrigation lumen which allows passage of an irrigation fluid as taught by Benning in order to keep the target site clean for visualization ([0023]). Further, 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 camera previously taught by Benning of the modified catheter disclosed by Gittard to provide a visual image of the target site as taught by Benning in order that the operator have access to still pictures and/or transient images that display time varying images of the target site ([0026]) to inform them of the progress made during delivery.
Regarding claim 18, in the modified system of Gittard, Gittard does not disclose a first valve configured for selectively permitting flow of an insufflation fluid via the therapeutic agent lumen of the catheter. However, Tan teaches a first valve (first valve 131) configured for selectively permitting flow of an insufflation fluid via the therapeutic agent lumen of the catheter ([0074], first valve 131 permits flow of a dialysate through a dialysate catheter by way of negative pressure). Therefore, 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 valve assembly previously taught by Tan of the modified system disclosed by Gittard to include a first valve with the ability to selectively permit the flow of fluid as taught by Tan in order to precisely quantify the injection amount of therapeutic agents and suction amount of waste fluids, as well as to inject therapeutic agents in a slow but continuous and stable manner ([0003]).
Regarding claim 19, in the modified system of Gittard, Gittard does not disclose an irrigation lumen, and wherein the system further includes a second valve configured for selectively permitting flow of an irrigation fluid via the irrigation lumen of the catheter.
However, Benning teaches an irrigation lumen (Fig. 2A, irrigation lumen 34a). Therefore, 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 modified catheter disclosed by Gittard to include an irrigation lumen as taught by Benning in order to keep the target site clean for visualization ([0023]).
Further, Tan teaches a second valve (second valve 132) configured for selectively permitting flow of the irrigation fluid via the irrigation lumen of the catheter ([0075], second valve 132 permits flow of dialysate through an injection catheter). Therefore, 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 valve assembly previously taught by Tan of the modified system disclosed by Gittard to include a second valve with the ability to selectively permit the flow of fluid as taught by Tan in order to precisely quantify the injection amount of therapeutic agents and suction amount of waste fluids, as well as to inject therapeutic agents in a slow but continuous and stable manner ([0003]).
Regarding claim 20, in the modified system of Gittard, Gittard does not disclose an aspiration lumen, and wherein the system further includes a third valve configured for selectively permitting flow of an aspiration fluid via the aspiration lumen of the catheter.
However, Benning teaches an aspiration lumen (Fig. 2A, aspiration lumen 34b). Therefore, 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 modified catheter disclosed by Gittard to include an aspiration lumen as taught by Benning in order to keep the target site free from fluid and biological material when performing therapy at the specific site ([0023]-[0024]).
Further, Tan teaches a third valve (third valve 133) configured for selectively permitting flow of an aspiration fluid via the aspiration lumen of the catheter ([0076], third valve 133 permits drainage of waste through a waste fluid catheter). valve assembly in terms of irrigation, insufflation, and therapeutic agent delivery.). Therefore, 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 valve assembly previously taught by Tan of the modified system disclosed by Gittard to include a third valve with the ability to selectively permit the flow of fluid as taught by Tan in order to precisely quantify the injection amount of therapeutic agents and suction amount of waste fluids, as well as to inject therapeutic agents in a slow but continuous and stable manner ([0003]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Gittard in view of Benning, Sanders, and Tan as applied to claim 15 above, and further in view of Talamonti (United States Patent Application Publication No. US 2009/0192448 A1).
Regarding claim 17, in the modified system of Gittard, Gittard does not disclose an aspiration lumen, and a distal segment of the aspiration lumen is at a non-parallel angle relative to a distal segment of the therapeutic agent lumen.
However, Benning teaches an aspiration lumen (Fig. 2A, aspiration lumen 34b). Therefore, 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 modified catheter disclosed by Gittard to include an aspiration lumen as taught by Benning in order to keep the target site free from fluid and biological material when performing therapy at the specific site ([0023]-[0024]).
Gittard in view of Benning, Sanders, and Tan does not explicitly disclose a distal segment of the aspiration lumen is at a non-parallel angle relative to a distal segment of the therapeutic agent lumen.
However, Talamonti teaches a distal segment of the aspiration lumen is at a non-parallel angle relative to a distal segment of the therapeutic agent lumen (FIG. 4, first lumen 56 has distal blunted region 74 with aperture 76, and second lumen 58 has distal apertures 68 that are a non-parallel exit to aperture 76). Therefore, 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 modified catheter disclosed by Gittard to position the distal segment of the aspiration lumen at a non-parallel angle relative to the distal segment of the therapeutic agent lumen as taught by Talamonti in order that there be a distinct separate between the aspiration and therapeutic agent lumens, with the aspiration lumen needing to carry larger particles than that of the therapeutic agent lumen ([0024]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Watts et al. (United States Patent Application Publication No. US 2006/0149129 A1) is considered relevant prior art with regards to a moveable catheter assembly with various lumens.
Slenker et al. (United States Patent Application Publication No. US 2008/0167527 A1) is considered relevant prior art with regards to a system of an endoscopic device with irrigation and aspiration ducts.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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