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 (IDS) submitted on 09/25/2024 and 12/03/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because in FIG. 1, reference character “114” has been used to designate both monitoring equipment and tracking system.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because in FIG. 2, reference character “206” has been used to designate both right main bronchus and left main bronchus.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign mentioned in the description: 115.
The drawings are objected to because in FIG. 3A, distal end 316 is labeled closest to the catheter 102, and proximal end 314 is labeled closer to the tumor. The examiner believes these labels are incorrectly placed and need to be swapped. This belief is based on FIG. 3B, where proximal end 314 is located on the left side of the balloon and distal end 316 is located on the right side of the balloon. The examiner is unsure which drawing portrays the correct alignment of the proximal and distal ends of the balloon, but one of the drawings should be corrected so both drawings have the labels in the same locations.
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.
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0017], the specification states “a plurality of reference sensor 18”. Based on future references of the reference sensors, the examiner believes “18” should be corrected to “118”.
In paragraph [0018], the specification states “catheter guide assembly 10”. Based on previous reference to the catheter guide assembly, the examiner believes “10” should be corrected to “106”.
In paragraph [0021], the specification uses acronyms “EMN” and “EM” which have not been disclosed in the disclosure. It is confusing to the examiner the meaning of these acronyms without proper context. The examiner suggest defining the acronyms, similar to how other acronyms have been defined in the same paragraph (EX: “inertial measurement unit (IMU)”).
In paragraph [0025], the specification states “inferior lobar bronchus 214”. However, inferior lobar bronchus had been previous disclosed with the reference number 212. The examiner suggest correcting “214” to “212”.
In paragraph [0042], the specification makes reference twice to “the method of FIG. 4”. However, FIG. 4 is and was described as previously “a view of a valve in accordance with the disclosure”. The examiner believes “FIG. 4” should be corrected to “FIG. 5”, as FIG. 5 was previously described as “a flow chart of a method in accordance with the disclosure”.
In paragraph, [0045], the specification states “workstation 1001”. Based on previous reference to the workstation, the examiner believes “1001” should be corrected to “701”.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: The claim makes reference to “the catheter” in the third line of the claim. The examiner is led to believe “the catheter” is the same as “ a dual lumen catheter” previously mentioned. For continuity purposes, the examiner suggest modifying “the catheter” to be “the dual lumen catheter” in order to remove any doubt that the two are the same. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: In the eighth line of the claim, the claim states “in fluid communication with second tube”. For proper grammar, the examiner suggest modifying the claim to state “in fluid communication with the second tube”. Further, in the tenth line of the claim, the claim states “release of inflation medium”. For proper grammar, the examiner suggest modifying the claim to state “release of an inflation medium”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 5 is 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.
Claim 5 recites the limitation "the therapy" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Franano et al. (United States Patent Application Publication No. US 2021/0386429 A1; herein, Franano), and further in view of McGurk et al. (United States Patent Application Publication No. US 2005/0288702 A1; herein McGurk).
Regarding claim 1, Franano discloses a method of applying therapy ([0074], “The present disclosure presents devices, systems and methods to occlude, embolize, or reduce the flow of biological fluid or material in biological conduits”) comprising: navigating a dual lumen catheter to a desired segmental bronchus (FIG. 16B view C-C, [0034], “The present disclosure describes the use of a highly flexible catheter or catheter assembly…to deliver a highly flexible detachable balloon”, first catheter 173 is around second catheter 174); inflating a balloon located on a distal portion of the catheter (FIG. 16, [0214], detachable balloon 10 on the distal end of catheter assembly 5, “balloon as used herein refers to a hollow structure with a nonporous wall 30 comprising a light or thin material that can be inflated or expanded”) via a first tube of the dual lumen catheter to isolate the segmental bronchus ([0214], [0298], "inflation port" 176 is for the injection of fluids into the first lumen 162 and "balloon…can be inflated or expanded, including with the injection of a fluid into a central void 115"; [0301], "a fluid communication can be made between the proximal hub 179 of the first catheter 173, the first lumen 162, and the central void 115 or interior volume of the balloon"; balloon is expanded to a point where a biological space is isolated); injecting a therapeutic medium into the isolated segmental bronchus via a second tube of the dual lumen catheter ([0219], "a solidifying fluid comprises an adhesive that can be injected as a fluid through...the second lumen 163 and...injected into a biological space 904 adjacent to an expanded balloon 10"); and retracting the dual lumen catheter to leave the balloon indwelling ([0224], "The detachable balloon catheter 1...is positioned and expanded...The second catheter 174 is then retracted. The first catheter 173 is then separated from proximal neck 130 of the balloon 10 using a detachment system, which may have various embodiments. Finally, the first catheter 173 is retracted. The expanded and detached balloon 10...remain within the patient "), wherein the balloon retains the injected therapeutic medium in the isolated segmental bronchus ([0221], "following placement of...solidifying fluid, or other balloon support material, the first catheter 173 can be separated from the expanded balloon 10 and the first and second catheters 173 & 174 can be removed from the patient while the balloon and...solidifying fluids or other balloon support materials remain in the patient.").
Franano does not explicitly disclose the device being used within the segmental bronchus. However, McGurk teaches a device being used within the segmental bronchus (FIG. 1, intra-bronchial device 10 disposed within a bronchial tube 12 of a patient's lung). 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 method disclosed by Franano to use the device within the segmental bronchus as taught by McGurk in order to treat diseased areas of the lung by specifically placing in segments of the bronchi ([0059]).
Regarding claim 8, in the modified method of Franano, Franano does not disclose navigating the dual lumen catheter to the indwelling balloon. However, McGurk teaches navigating the dual lumen catheter to the indwelling balloon ([0066], FIG. 5 has annular engagement structure 80 which engages with annular channel 82 of the intra-bronchial device, and has the ability to engage and disengage by movement of coupler sleeve 84. One having ordinary skill in the art would infer that after disengaging connection, connection could be reengaged by advancing the coupler sleeve 84 distally at a later moment, meaning catheter 76 would be renavigated through the lungs to reengage connection). 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 method disclosed by Franano to navigate the dual lumen catheter to the indwelling balloon as taught by McGurk in order that the device be able to reach desired areas of the bronchial tube (FIG. 5), as well as engage and disengage when need be ([0066]).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Franano in view of McGurk as applied to claim 1 above, and further in view of Scarpine et al. (United States Patent Application Publication No. US 2017/0105857 A1; herein, Scarpine).
Regarding claim 2, in the modified method of Franano, Franano does not disclose inflation of the balloon engages securing features with the segmental bronchus to hold the balloon in place. However, Scarpine teaches inflation of the balloon engages securing features with the segmental bronchus to hold the balloon in place (FIG. 4, [0055], extensible members 126 engage with the medical device and lock the extensible members into place on the medical device; the examiner interprets this action as a similar action in which securing features would engage the segmental bronchus to hold the balloon in place). 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 balloon of the catheter disclosed by Franano to include securing features as taught by Scarpine in order to create an engagement between the balloon and walls on the segmental bronchus by radially interlocking the securing features with the segmental bronchus ([0063-0064]).
Regarding claim 3, in the modified method of Franano, Franano does not disclose the securing features are micro-barbs. However, Scarpine teaches the securing features are micro-barbs (FIG. 7A, extensible members 126' are protrusions). 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 balloon of the catheter disclosed by Franano to include micro-barbs as securing features as taught by Scarpine in order to create an engagement between the balloon and walls on the segmental bronchus by radially interlocking the securing features with the segmental bronchus ([0063-0064]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Franano in view of McGurk and Scarpine as applied to claim 2 above, and further in view of To (United States Patent Application Publication No. US 2009/0112239 A1).
Regarding claim 4, in the modified method of Franano, Franano does not disclose the securing features are an adhesive coating formed on an exterior surface of the balloon that adheres to an airway wall of the segmental bronchus. However, To teaches the securing features are an adhesive coating formed on an exterior surface of the balloon (Figure 1, [0034], [0039], dilatation balloon with sticky outer surface) that adheres to an airway wall of the segmental bronchus ([0057], sticky features of the outer surface can adhere to the lumen wall). 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 balloon of the catheter disclosed by Franano to include and adhesive coating on the exterior surface of the balloon as taught by To in order that there be no gaps in the walls of the body lumen due to the adhesive attaching circumferentially in between crevices ([0014]). The adhesive also does not activate until pressure is provided, allowing it to smoothly enter and exit the body ([0046-0047]).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Franano in view of McGurk as applied to claim 1 above, and further in view of Thiel et al. (United States Patent Application Publication No. US 2017/0112571 A1; herein, Thiel).
Regarding claim 5, in the modified method of Franano, Franano does not disclose imaging the segmental bronchus with the balloon indwelling to assess the progression of the therapy. However, Thiel teaches imaging the segmental bronchus with the balloon indwelling to assess the progression of the therapy ([0088], imaging systems are used to monitor various parts of ablation procedures, and can provide software designed to automatically obtain images of a tissue region). 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 method disclosed by Franano to include imaging to assess progression of therapy as taught by Thiel in order to allow a user to make predictions based upon known properties of tissue and vasculature ([0087]), as well as to predict the shape and size of the tissue region to be treated ([0088]).
Regarding claim 6, in the modified method of Franano, Franano does not disclose determining whether the therapeutic medium is draining from the segmental bronchus. However, Thiel teaches determining whether the therapeutic medium is draining from the segmental bronchus ([0088], the software can automatically detect any changes in the tissue region, which one having ordinary skill in the art could translate to detecting if medium is present or not in the imaged zone). 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 method disclosed by Franano to include determining if therapeutic medium is draining from a space as taught by Thiel in order to allow a user to make predictions based upon known properties of tissue and vasculature ([0087]), and inform decision making for next steps.
Regarding claim 7, in the modified method of Franano, Franano does not disclose analyzing a distribution of a biological marker, wherein the biological marker is configured to bind with a tumor or lesion. However, Thiel discloses analyzing a distribution of a biological marker, wherein the biological marker is configured to bind with a tumor or lesion ([0088], contrast agent can be supplied to patient and the contrast agent perfusing through a particular tissue region that is undergoing the ablation procedure is monitored, which monitoring and adjustments could be done by software.). It is also known in the art that contrast agents are able to bind to biological components. 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 method disclosed by Franano to analyzing a distribution of a biological marker, such as contrast as taught by Thiel in order to allow a user to make predictions based upon known properties of tissue and vasculature ([0087]), as well as to predict the shape and size of the tissue region to be treated ([0088]).
Claims 9-11, 13, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Franano in view of McGurk as applied to claim 8 above, and further in view of Kokish (United States Patent Application Publication No. US 2002/0068953 A1; herein, Kokish).
Regarding claim 9, in the modified method of Franano, Franano discloses the first tube is configured to supply additional inflation medium into the balloon ([0214], [0298], "inflation port" 176 is for the injection of fluids into the first lumen 162 and "balloon as used herein refers to a hollow structure with a nonporous wall 30 comprising a light or thin material that can be inflated or expanded, including with the injection of a fluid into a central void 115"). Franano does not disclose passing the dual lumen catheter through a first valve on the balloon.
However, Kokish teaches passing the dual lumen catheter through a first valve on the balloon (FIG. 1, outer tubular member 25 and an inner tubular member 26 both pass through proximal secured end 21). 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 method disclosed by Franano to pass the dual lumen catheter through a first valve of the balloon as taught by Kokish in order to create a variable radial force along the balloon working section and expand more against the walls ([0010]), while protecting any mediums from escaping either side of the balloon, or within the balloon.
Regarding claim 10, in the modified method of Franano, Franano discloses passing the second tube through a second valve on the balloon (FIG. 20A-C, second catheter 174 extends through the entirety of balloon 10).
Regarding claim 11, in the modified method of Franano, Franano discloses injecting additional therapeutic medium into the isolated segmental bronchus ([0219], "a solidifying fluid comprises an adhesive that can be injected as a fluid through the first lumen 162 or the second lumen 163 and…into a biological space 904 adjacent to an expanded balloon 10").
Regarding claim 13, in the modified method of Franano, Franano does not disclose deflating the balloon. However, McGurk teaches deflating the balloon ([0077] "It may also be necessary after deployment of an intra-bronchial device to deflate the balloon and remove the device from the patient."). 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 method disclosed by Franano to deflate the balloon as taught by McGurk in order to safely remove or reposition the balloon ([0077]).
Regarding claim 15, in the modified method of Franano, Franano does not disclose extracting the dual lumen catheter and balloon from the segmental bronchus. However, McGurk teaches extracting the dual lumen catheter and balloon from the segmental bronchus ([0077], "Once the balloon is deflated, the device may be coupled to a catheter as shown in FIGS. 11-14 and removed from the patient and/or deployed at a different site."; One having ordinary skill in the art would understand that by removing the balloon, the catheter would be removed as well with the balloon.). 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 method disclosed by Franano to extract the catheter and balloon as taught by McGurk in order to safely remove or reposition the balloon ([0077]) and protect the user from prolonged use of the device.
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Franano in view of McGurk as applied to claim 10 above, and further in view of Loske (United States Patent Application Publication No. US 2016/0367747 A1).
Regarding claim 12, in the modified method of Franano, Franano does not disclose extracting the therapeutic medium from the segmental bronchus. However, Loske teaches extracting the therapeutic medium from the segmental bronchus (Fig. 7a, negative-pressure generating system 30 connects to catheter 20, which includes the fluid-carrying element 2 and balloon 1. Under a negative pressure, liquids or gases are carried through the open-pore wall 2c into the inner lumen 2g of the tube. The liquids or gases would include any therapeutic medium.). 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 method disclosed by Franano to extract the therapeutic medium as taught by Loske in order that fast and reliable drainage of secretions by suction be achieved ([0010]), protecting the user from residual therapeutic medium from residing in the body when not needed.
Regarding claim 14, in the modified method of Franano, Franano does not disclose the deflation comprises applying a vacuum to the balloon, wherein the vacuum secures the balloon to a portion of the dual lumen catheter. However, Loske teaches the deflation comprises applying a vacuum to the balloon (Fig. 7a, negative-pressure generating system 30 connects to catheter 20, which includes the fluid-carrying element 2 and balloon 1), wherein the vacuum secures the balloon to a portion of the dual lumen catheter (One having ordinary skill in the art would infer that the negative-pressure generating system 30 would be able to deflate the balloon if suction was applied directly to the balloon.). 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 method disclosed by Franano to apply a vacuum to the balloon for deflation as taught by Loske in order that fast and reliable drainage of secretions by suction be achieved ([0010]), as well as safe removal of the balloon.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Franano, and further in view of McGurk and Kokish.
Regarding claim 16, Franano discloses a therapy application system (FIG. 16, catheter assembly 5) comprising: a dual lumen catheter (FIG. 16B view C-C, first catheter 173 around second catheter 174 make up a dual lumen catheter) including a first tube (first catheter 173) and a second tube (second catheter 174), the dual lumen catheter configured for navigation within airways of a patient ([0034], "The present disclosure describes the use of a highly flexible catheter or catheter assembly (also called the “delivery catheter” or “first catheter”) to deliver a highly flexible detachable balloon"); a balloon formed on a distal portion of the dual lumen catheter (FIG. 16, detachable balloon 10 on distal end of catheter assembly 5); an inflation source ([0298], FIG. 16A, "inflation port" 176) in fluid communication with the first tube ([0298], FIG. 16D view C-C, "inflation port" 176 is for the injection of fluids into the first lumen 162); and a therapeutic medium source ([0217], [0219], [0220], solidifying fluid) in fluid communication with second tube ([0219], "a solidifying fluid comprises an adhesive that can be injected as a fluid through the first lumen 162 or the second lumen 163 and into the central void 115 of the balloon 10 or injected into a biological space 904 adjacent to an expanded balloon 10"), the first tube being in fluid communication with the balloon ([0301], "a fluid communication can be made between the proximal hub 179 of the first catheter 173, the first lumen 162, and the central void 115 or interior volume of the balloon") and release of inflation medium from the inflation source expands the balloon and isolates a segmental bronchus ([0214], [0298], "inflation port" 176 is for the injection of fluids into the first lumen 162 and "balloon as used herein refers to a hollow structure with a nonporous wall 30 comprising a light or thin material that can be inflated or expanded, including with the injection of a fluid into a central void 115"), and wherein the second tube extends beyond the second valve (FIG. 20A-C, second catheter 174 extends through the entirety of balloon 10) and release of the therapeutic medium from the therapeutic medium source floods the isolated segmental bronchus ([0219], "a solidifying fluid comprises an adhesive that can be injected as a fluid through the first lumen 162 or the second lumen 163 and…into a biological space 904 adjacent to an expanded balloon 10").
Franano does not disclose the device being used within the segmental bronchus, the balloon including a first valve on a proximal portion of the balloon and a second valve on a distal portion of the balloon, and wherein the dual lumen catheter extends past the first valve and into the balloon.
However, McGurk teaches a device being used within the segmental bronchus (FIG. 1, intra-bronchial device 10 disposed within a bronchial tube 12 of a patient's lung). 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 method disclosed by Franano to use the device within the segmental bronchus as taught by McGurk in order to treat diseased areas of the lung by specifically placing in segments of the bronchi ([0059]).
Franano in view of McGurk still does not disclose the balloon including a first valve on a proximal portion of the balloon and a second valve on a distal portion of the balloon, and wherein the dual lumen catheter extends past the first valve and into the balloon.
However, Kokish teaches the balloon including a first valve on a proximal portion of the balloon (FIG. 1, proximal secured end 21) and a second valve on a distal portion of the balloon (FIG. 1, distal secured end 22), and wherein the dual lumen catheter extends past the first valve and into the balloon (FIG. 1, outer tubular member 25 and an inner tubular member 26 both pass through proximal secured end 21). 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 system disclosed by Franano to have a first and second valve of the balloon, while also passing the dual lumen catheter through a first valve of the balloon as taught by Kokish in order to create a variable radial force along the balloon working section and expand more against the walls ([0010]), while protecting any mediums from escaping either side of the balloon, or within the balloon.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Franano in view of McGurk and Kokish as applied to claim 16 above, and further in view of Loske.
Regarding claim 17, in the modified system of Franano, Franano does not disclose a vacuum source in fluid communication with the second tube and configured to extract the therapeutic medium from the isolated segmental bronchus. However, Loske teaches a vacuum source (negative-pressure generating system 30) in fluid communication with the second tube (Fig. 7b, negative-pressure generating system 30 is in fluid communication with the catheter 20 by means of fluid connection container 40; [0014], the tube can be connected fluidically via a connecting element to a negative-pressure generating system. One having ordinary skill in the art would reasonably understand suction being applied to a specific tube based on how the tube connects to the fluid connection container 40.) and configured to extract the therapeutic medium from the isolated segmental bronchus (Fig. 7b, Under a negative pressure, liquids or gases are carried through the open-pore wall 2c into the inner lumen 2g of the tube. The liquids or gases would include any therapeutic medium.). 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 Franano to include a vacuum connected to the second tube to extract the therapeutic medium as taught by Loske in order that fast and reliable drainage of secretions by suction be achieved ([0010]), protecting the user from residual therapeutic medium from residing in the body when not needed.
Regarding claim 18, in the modified system of Franano, Franano does not disclose the vacuum source is in fluid communication with the first tube to deflate the balloon. However, Loske teaches the vacuum source is in fluid communication with the first tube to deflate the balloon (Fig. 7b, negative-pressure generating system 30 is in fluid communication with the catheter 20 by means of fluid connection container 40.; [0014], the tube can be connected fluidically via a connecting element to a negative-pressure generating system. One having ordinary skill in the art would infer that the negative-pressure generating system 30 would be able to deflate the balloon if suction was applied directly to the balloon.). 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 Franano to apply a vacuum to the balloon for deflation as taught by Loske in order that fast and reliable drainage of secretions by suction be achieved ([0010]), as well as safe removal of the balloon.
Regarding claim 19, in the modified system of Franano, Franano does not disclose the vacuum applied to the balloon secures the balloon to the dual lumen catheter for removal from the airways of the patient. However, Loske teaches the vacuum applied to the balloon secures the balloon to the dual lumen catheter for removal from the airways of the patient (Fig. 7a, One having ordinary skill in the art would infer that the negative-pressure generating system 30 would be able to deflate the balloon if suction was applied directly to the balloon, and thereby secure the balloon to the suction coming from the 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 modified system disclosed by Franano to apply a vacuum to the balloon for removal as taught by Loske in order for safe removal of the balloon.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Franano in view of McGurk and Kokish as applied to claim 16 above, and further in view of Scarpine.
Regarding claim 20, in the modified system of Franano, Franano does not disclose securing features on an exterior surface of the balloon, wherein the securing features is one or more of an adhesive, micro-barbs, hooks, or spikes. However, Scarpine teaches securing features on an exterior surface of the balloon, wherein the securing features is one or more of an adhesive, micro-barbs, hooks, or spikes (FIG. 4 & FIG. 7A, extensible members 126' are protrusions). 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 balloon of the catheter disclosed by Franano to include micro-barbs as securing features as taught by Scarpine in order to create an engagement between the balloon and walls on the segmental bronchus by radially interlocking the securing features with the segmental bronchus ([0063-0064]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hakki (United States Patent No. US 5,188,592 A) is considered relevant prior art with regards to a balloon catheter that utilizes suction to remove material from a lung.
Fischer, JR. et al. (United States Application Publication No. US 2017/0189644 A1) is considered relevant prior art with regards to a balloon catheter that can introduce material to the body.
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..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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