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
The claims filed 09/15/2026 have been entered. Claims 1-10, 12, 14-16, 18-22 are pending in the application. Applicant's amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 06/25/2026.
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.
Claims 1-6, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2019/0015639) in view of Mayse (US 2023/0075851) and further in view of Craig (US 2020/0254225).
Regarding Claim 1, Wang discloses a method of treating a central airway obstruction (CAO), benign airway stenosis, asthma, chronic obstructive pulmonary disease (COPD), or an airway tumor in a human subject (Para 0012), the method comprising: inserting a drug-coated balloon catheter into a target site in an airway (“airways”; Para 0043); inflating the balloon to dilate the airway and deliver a therapeutic agent to the airway wall; deflating the balloon; and withdrawing the balloon catheter from the target site (Para 0119); wherein the balloon is coated with a coating layer comprising the therapeutic agent and one or more additives, wherein the therapeutic agent comprises paclitaxel, sirolimus, or a derivative thereof (Para 0037, 0141-0142).
While Wang teaches treating COPD and describes that it is characterized by chronic bronchitis (i.e. inflammation of the bronchial airways) in Para 0009 and further teaches locally treating strictures in airways (Para 0039, 0043) distinct from the trachea or sinus (i.e. likely the bronchus) is silent regarding the target site is in bronchus intermedius, lobar bronchus, segmental bronchus, or sub-segmental bronchus.
Mayse teaches that strictures and obstructions due to COPD and other pulmonary diseases can occur in any branch of the bronchi including the bronchus intermedius and lobar bronchi (Para 0004, 0076, 0081). Mayse further teaches that paclitaxel can be used to treat these strictures (Para 0089).
Craig teaches an analogous method of treating an obstructed site within the segmental bronchus comprising delivering paclitaxel to a target site within the segmental bronchus (Para 0041-0042).
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 to have the target site be a segmental bronchus, bronchus intermedius, or lobar bronchus and modify the balloon catheter to be sized for the target portion of the bronchus as taught by Mayse and Craig in order to have a method that can treat obstructions in those portions of the airway (Para 0041 -Craig; Para 0081 -Mayse).
Examiner notes that Wang teaches that strictures are to be treated locally with direct contact within the stricture (Para 0039, 0043), therefore, one of ordinary skill would understand that to treat strictures in the segmental bronchus, bronchus intermedius, or lobar bronchus, the balloon must contact the strictures in those portions of the bronchus. Thus, the modified invention would teach all of the claimed elements.
Regarding Claim 2, the modified invention of Wang, Mayse, and Craig discloses the balloon has a nominal diameter of 4 mm to 20 mm and a length of 30 mm to 65 mm (Para 0134 -Wang).
Regarding Claim 3, the modified invention of Wang, Mayse, and Craig discloses the coating layer comprises the therapeutic agent at a dose density of 1 pg/mm2 to 20 pg/mm2, the one or more additives comprise pentaerythritol ethoxylate (PEE), and the weight ratio of the one or more additives to the therapeutic agent in the coating is from 0.01:1 to 10:1 (“pentaerythritol ethoxylate can be the water-soluble additive”; Para 0120, 0144, 0214 -Wang).
Regarding Claim 4, the modified invention of Wang, Mayse, and Craig discloses the balloon is soaked in saline or water for prior to insertion to hydrate the coating (Para 0249 -Wang), however, is silent regarding the how long the balloon is to be soaked for.
Wang in Para 0315 indicates that it takes at least 1 minute to hydrate the coating.
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 to soak the balloon for at least 1 minute in order to hydrate the coating (Para 0315).
Regarding Claim 5, the modified invention of Wang, Mayse, and Craig discloses the balloon is inflated at the target site for 1 minute to 10 minutes (“the inflation period is from 0.1 minutes to 10 minutes”; Para 0123 -Wang).
Regarding Claim 6, the modified invention of Wang, Mayse, and Craig discloses the method results in: a reduction in the Myer-Cotton grade of the stenosis by at least one grade at 1 month post-procedure, a freedom from symptom-driven target lesion reintervention of at least 80% at 6 months post-procedure, an improvement in FEV1 of at least 100 mL in about 50% to about 70% of patients at 12 months post-procedure, an improvement in mMRC dyspnea score of at least 1 grade in about 75% to about 90% of patients at 12 months post-procedure, an improvement in Peak Expiratory Flow of greater than 18.8 L/min in about 85% to about 95% of patients at 12 months post-procedure, or a combination thereof (Examiner notes that the method disclosed by Wang appears to be identical to the method disclosed in paragraphs 0150-0155 of the instant specification (See rejection of claim 1 above). Since the limitations of this claim are a result of performing the disclosed steps with the disclosed structure and Wang, Mayse, and Craig teach all of the disclosed steps and structure, one of ordinary skill in the art would understand that the method disclosed by Wang, Mayse, and Craig would necessarily result in the same outcomes. It has been held that when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).)
Regarding Claim 22, the modified invention of Wang, Mayse, and Craig discloses the human subject has a Myer-Cotton grade 2, 3, or 4 airway stenosis at the target site prior to the inserting, and wherein the method results in a reduction in the Myer-Cotton grade of the airway stenosis by at least one grade at one month post-procedure (Examiner notes that the method disclosed by Wang appears to be identical to the method disclosed in paragraphs 0150-0155 of the instant specification (See rejection of claim 1 above). Since the limitations of this claim are a result of performing the disclosed steps with the disclosed structure and Wang, Mayse, and Craig teach all of the disclosed steps and structure, one of ordinary skill in the art would understand that the method disclosed by Wang, Mayse, and Craig would necessarily result in the same outcomes. It has been held that when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).).
Claims 7-10, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2019/0015639) in view of Hossainy (US 2015/0305943).
Regarding Claim 7, Wang discloses a method of treating chronic rhinosinusitis (CRS) or chronic rhinosinusitis with nasal polyps (CRSwNP) in a human subject (Para 0011, 0043, 0055), the method comprising: identifying a target lesion in a paranasal sinus or sinus drainage pathway; inserting a drug-coated balloon catheter into the target lesion (Para 0119), wherein the balloon is coated with a coating layer comprising a therapeutic agent and one or more additives, wherein the therapeutic agent comprises paclitaxel, sirolimus, or a derivative thereof (Para 0037, 0141-0142); the balloon is coated with the therapeutic agent at a dose density of 1 pg/mm2 to 20 pg/mm2, wherein the one or more additives comprise pentaerythritol ethoxylate (PEE), and wherein the weight ratio of the one or more additives to therapeutic agent in the coating is from 0.01:1 to 10:1 (“pentaerythritol ethoxylate can be the water-soluble additive”; Para 0120, 0144, 0214); inflating the balloon to dilate the lesion and deliver the therapeutic agent to the tissue; deflating the balloon; and withdrawing the balloon catheter (Para 0119).
While Wang teaches treating strictures in the sinuses, it is not abundantly clear the method is used to treat chronic rhinosinusitis or chronic rhinosinusitis with nasal polyps.
Hossainy teaches an analogous method of treating a stricture in the sinuses caused by chronic rhinosinusitis (Para 0008, 00015); the method comprising identifying a target lesion in a paranasal sinus or sinus drainage pathway; inserting a drug-coated balloon catheter into the target lesion, wherein the balloon is coated with a coating layer comprising a therapeutic agent comprising paclitaxel (Para 0103, 0108).
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 Wang to be used to treat chronic rhinosinusitis as taught by Hossainy in order to have a method that can treat strictures caused by chronic rhinosinusitis without the negative effects of standard treatments that rely on steroids (Para 0008).
Examiner notes that the modified invention of Wang and Hossainy discloses a treated patient population having blood sampled during a ten-day period following treatment, fewer than 25% of the treated patient population have the therapeutic agent measurable in blood at one or more time points during the ten-day period, and the therapeutic agent is not measurable in blood of any patient of the treated patient population by day 7 following treatment (the method disclosed by Wang appears to be identical to the method disclosed in paragraphs 0167-174 of the instant specification (See Rejection of Claim 7 in view of Wang and Hossainy above). Since the limitations of this claim are a result of performing the disclosed steps with the disclosed structure and Wang and Hossainy teach all of the disclosed steps and structure, one of ordinary skill in the art would understand that the method disclosed by Wang and Hossainy would necessarily result in the same outcomes. It has been held that when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
Regarding Claim 8, the modified invention of Wang and Hossainy discloses the balloon is soaked in saline or water for prior to insertion to hydrate the coating (Para 0249 -Wang), however, is silent regarding the how long the balloon is to be soaked for.
Wang in Para 0315 indicates that it takes at least 1 minute to hydrate the coating.
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 to soak the balloon for at least 1 minute in order to hydrate the coating (Para 0315).
Regarding Claim 9, the modified invention of Wang and Hossainy discloses the balloon is inflated at the target site for 1 minute to 10 minutes (“the inflation period is from 0.1 minutes to 10 minutes”; Para 0123 -Wang).
Regarding Claim 10, the modified invention of Wang and Hossainy discloses the balloon has a labeled diameter of 7 mm to 20 mm and a length of 20 mm to 35 mm (Para 0134 -Wang).
Regarding Claim 12, the modified invention of Wang and Hossainy discloses the method results in: a freedom from target lesion reintervention due to recurrence of CRS or CRSwNP of at least 90% at 6 months post-procedure, or a mean change from baseline in SNOT-22 score of at least 8.9 points at 12 months post- procedure, or a mean change from baseline in Lund-Mackay CT score of at least 5 points at 12 months post-procedure, or a combination thereof (Examiner notes that the method disclosed by Wang and Hossainy appears to be identical to the method disclosed in paragraphs 0167-0170 of the instant specification (See rejection of claim 7 above). Since the limitations of this claim are a result of performing the disclosed steps with the disclosed structure and Wang and Hossainy teach the disclosed steps and structure, one of ordinary skill in the art would understand that the method disclosed by Wang and Hossainy would necessarily result in the same outcomes. It has been held that when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2019/0015639) in view of Hossainy (US 2015/0305943) and further in view of Stankus (US 2020/0230373).
Regarding Claim 21, the modified invention of Wang and Hossainy discloses all of the elements of the invention as discussed above, however, is silent regarding after the identifying the target lesion and before inserting the drug-coated balloon catheter into the target lesion, performing at the target lesion surgical dissection, irrigation, or balloon dilation with an uncoated balloon.
Stankus teaches an analogous method of delivering a drug by inflating a drug-coated balloon catheter into the target lesion where after the identifying the target lesion and before inserting the drug-coated balloon catheter into the target lesion, performing at the target lesion irrigation (Para 0060).
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 to include irrigating the target lesion before inserting the drug-coated balloon catheter in order to enhance drug release from the expandable member (Para 0060).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2019/0015639) in view of Hossainy (US 2015/0305943) and further in view of Becker (US 2004/0064150).
Regarding Claim 14, the modified invention of Wang and Hossainy discloses all of the elements of the invention as discussed above, however, is silent regarding the method comprises: performing a surgical ethmoidectomy to create a resected ethmoid cavity at the target lesion; wherein inflating the balloon comprises inflating the balloon in the resected ethmoid cavity to reshape and flatten residual bony partitions.
Becker teaches an analogous method of treating a sinus system, including dilating a lesion (Para 0013) and performing a surgical ethmoidectomy to create a resected ethmoid cavity at the target lesion (“obstructed or narrowed ostium or duct of a sinus”, Para 0019); wherein inflating the balloon comprises inflating the balloon in the resected ethmoid cavity to reshape and flatten residual bony partitions (Para 0050-0051).
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 to include performing a surgical ethmoidectomy as taught by Becker in order to restore patency of the sinus by enlarging the opening and allowing mucociliary clearance of mucus (Para 0008).
Claim 15 rejected under 35 U.S.C. 103 as being unpatentable over Hossainy (US 2015/0305943) in view of Wang (US 2019/0015639).
Regarding Claim 15, A method of treating a eustachian tube disorder in a human subject (Para 0010), the method comprising: inserting a balloon catheter into the eustachian tube (Para 0101), wherein the balloon is coated with a coating layer (206, Fig 14) comprising a therapeutic agent, wherein the therapeutic agent comprises paclitaxel (Para 0108); inflating the balloon to dilate the eustachian tube and deliver the therapeutic agent to the tissue (Para 0015, 0103).
Hossainy is silent regarding one or more additives comprising pentaerythritol ethoxylate (PEE)deflating the balloon; and withdrawing the balloon catheter
Wang teaches a method of treating a nonvascular body lumen wherein a balloon of a balloon catheter is coated with coating layer comprising a therapeutic agent and one or more additives wherein the therapeutic agent comprises paclitaxel, and wherein the one or more additives comprise pentaerythritol ethoxylate (PEE) (Para 0141-0142); inflating the balloon to dilate the lesion and deliver the therapeutic agent to the tissue; deflating the balloon; and withdrawing the balloon catheter (Para 0119).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify method to include deflating the balloon and withdrawing the balloon catheter in order to have a method that removes the balloon from the lumen once the drug is delivered and the balloon is no longer needed (Para 0119). 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 coating layer as Wang teaches that pentaerythritol ethoxylate can be added to paclitaxel to improve the adhesive properties of the drug, solubility of the drug, and/or drug permeation (Para 0208).
Claims 16, 18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2019/0015639) in view of Scopton (US 2004/0116852) and further in view of Cordray (US 2014/0243872).
Regarding Claim 16, Wang discloses a system comprising: a balloon dilation device comprising a tubular balloon catheter with an integrated inflation lumen, a hollow region under the balloon; and a guidewire lumen in the distal portion of the device, through which a positioning instrument may be inserted; ; and a positioning instrument (“guidewire”) configured to have a preconfigured tip shape inserted into the balloon device (Para 0312; See Fig 3).
Wang is silent regarding an access port in the distal portion of the device but proximal to the balloon, through which a positioning instrument may be inserted, and a stiffening member disposed within the balloon catheter proximal to the access port, the stiffening member extending from a fluid input port of the balloon catheter to a proximal edge of the access port; and a positioning instrument configured to have a sinus seeker tip thereof with a preconfigured tip shape inserted into the balloon device through the access port in the distal portion of the device but proximal to the balloon, wherein the sinus seeker tip is attached to a handle.
Scopton teaches an analogous balloon catheter comprising an access port (20, Fig 1) in the distal portion of the device but proximal to the balloon, through which a positioning instrument (14, Fig 1) may be inserted, and a stiffening member (36, Fig 1) disposed within the balloon catheter proximal to the access port, the stiffening member extending from a fluid input port of the balloon catheter to a proximal edge of the access port (Para 0020); and a positioning instrument configured to have a preconfigured tip shape (26, Fig 1; the claim language doesn’t require any specific shape and thus a straight distal tip can interpreted as the preconfigured tip shape) inserted into the balloon device through the access port in the distal portion of the device but proximal to the balloon (Para 0016).
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 device disclosed by Wang to include a stiffening member, an access port, and a positioning instrument as taught by Scopton in order to increases the longitudinal strength and rigidity of the catheter to facilitate insertion of the device into body lumens, facilitate positioning of the balloon catheter at the target site, and allow for a shorter positioning instrument (Para 0003, 0005, 0017, 0020).
The modified invention of Wang and Scopton are silent regarding the positioning instrument having a sinus seeker tip and wherein the sinus seeker tip is attached to a handle.
Cordray teaches a positioning instrument (12, Fig 1) configured to have a sinus seeker tip (14, Fig 1; Para 0039) thereof with a preconfigured tip shape inserted into the balloon device (Para 0041), wherein the sinus seeker tip is attached to a handle (20, Fig 2).
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 positioning instrument have a sinus seeker tip and a handle as taught by Cordray in order to have a positioning instrument that is shaped and angled for a specific sinus being treated (Para 0020, 0040, 0044).
Regarding Claim 18, the modified invention of Wang, Scopton, and Cordray discloses the balloon is coated with a coating comprising a therapeutic drug comprising paclitaxel, sirolimus, or a derivative thereof, and wherein the coating further comprises one or more additives (Para 0037, 0141-0142-Wang).
Regarding Claim 20, the modified invention of Wang, Scopton, and Cordray discloses a method of positioning the balloon dilation device of the system of claim 16 (See rejection of claim 16 above) in a nasal cavity, paranasal sinus, or sinus drainage pathway, comprising: inserting the sinus seeker tip of the positioning instrument into the access port of the balloon dilation device; and positioning the balloon catheter and positioning instrument into the nasal cavity and directing the balloon catheter to the target location (Para 0016 -Scopton; Para 0119 -Wang).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2019/0015639) in view of Scopton (US 2004/0116852) and further in view of Cordray (US 2014/0243872) and further in view of Sweeney (US 2018/0185618) and further in view of Carter (US 2008/0051721)
Regarding Claim 19, the modified invention of Wang, Scopton, and Cordray discloses all of the elements of the invention as discussed above, however, is silent regarding the positioning instrument includes interchangeable tips secured by a set screw or threaded attachment.
Sweeney further teaches an analogous positioning instrument wherein the positioning instrument includes interchangeable tips (Para 0062-0063).
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 positioning instrument to include interchangeable tips as taught by Sweeney in order to allow a staff member to choose a tip based on the function the guide will be performing in the body of the patient (Para 0063).
The modified invention of Wang, Scopton, Cordray, and Sweeney disclose all of the elements of the invention, however, are silent regarding the interchangeable tips are secured by a set screw or threaded attachment.
Carter teaches an analogous positioning instrument (20, Fig 1) having an interchangeable tip (30, Fig 1) wherein the interchangeable tip is secured by a set screw or threaded attachment (threaded attachment 62, Fig 3C; Para 0044).
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 attachment mechanism of the tip to be a threaded attachment as taught by Carter as threading is one of many well-known connection means that can be used for releasable attachment (Para 0041-0044).
Response to Arguments
Applicant’s arguments filed 09/15/2026, on pages 8-13, regarding Wang and Watanabe failing to teach all of the limitations of claims 1-6 have been fully considered but are moot in view of the current rejection that no longer relies on Watanabe. The current rejection relies on Wang, Mayse, and Craig to teach that strictures and obstructions due to COPD and other pulmonary diseases can occur in any branch of the bronchi including the segmental bronchus, bronchus intermedius, or lobar bronchus (Para 0004, 0076, 0081 -Mayse)(Para 0041 -Craig) and that one of ordinary skill would understand that to treat strictures in the segmental bronchus, bronchus intermedius, or lobar bronchus, the balloon must contact the strictures in those portions of the bronchus (Para 0039, 0043 -Wang).
Applicant’s arguments filed 09/15/2026, on pages 13-15, regarding Wang and Hossainy failing to teach “fewer than 25% of the treated patient population have the therapeutic agent measurable in blood at one or more time points during the ten-day period, and the therapeutic agent is not measurable in blood of any patient of the treated patient population by day 7 following treatment” have been fully considered but is not persuasive. As detailed in the rejection above, since the limitations of this claim are a result of performing the disclosed steps with the disclosed structure and Wang and Hossainy teach all of the disclosed steps and structure, one of ordinary skill in the art would understand that the method disclosed by Wang and Hossainy would necessarily result in the same outcomes. It has been held that when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). Applicant argues that Wang and Hossainy teaching an identical method assumes selecting paclitaxel from Hossainy, PEE from Wang, and operating the resulting balloon in a human CRS or CRSwNP treatment. Firstly, Wang teaches paclitaxel and PEE for treating a sinus in Para 0141-0142. Hossainy is relied on to teach that a method similar to Wangs would be obvious to use to treat chronic rhinosinusitis. Wang provides all of the other claimed method steps. Secondly, Wang teaches the dose density and ratio of therapeutic agent to additives as claimed in claim 7 (See rejection of claim 7 above). Lastly, the instant specification and claims do not appear to teach a number of balloons per patient. If this is a critical step that differentiates the invention from the prior art, it should be part of the application and may amount to a 112a rejection (MPEP 2172.01).
Applicant’s arguments filed 09/15/2026, on pages 16, regarding Wang and Hossainy failing teach the population-level outcomes have been fully considered but are not persuasive. Applicant argues that the outcomes are dependent on patient selection, baseline disease, procedural treatment, follow-up, and definition and measurement of each endpoint. Similar to the argument above, this claim appears to be claiming results for a method that is not claimed. The claimed method lacks any mention to patient selection and any follow-up care. As detailed in the rejection of claims 7 and 12, the baseline disease and procedure are taught by the prior art. Thus, as framed by applicant in claim 12, the method should result in the claimed results.
Applicant’s arguments filed 09/15/2026, on pages 17-19, regarding Becker failing to teach a resected ethmoid cavity and flattening and reshaping residual bony partitions have been fully considered but is nor persuasive. Becker teaches, in Para 0050-0051, at least a partial resection of the ethmoid cavity. The claim does not require a full resection. Further, Para 0051 and Fig 14 describe removing the ethmoid sinus cells and then inflating the balloon in the cavity. Lastly, Figures 10-15, show the flattening and reshaping of residual bony partitions as the procedure moves toward the sphenoid sinus. Thus, Becker meets all of the limitations of claim 14.
Applicant’s arguments filed 09/15/2026, on pages 20-22, regarding Hossainy does not disclose the coating specifically for the treatment of a Eustachian-tube disorder have been fully considered but is not persuasive. As detailed in the rejection above, Hossainy teaches paclitaxel as a drug that can treat a eustachian tube disorder (Para 0108). Wang teaches that PEE can be paired with paclitaxel to improved properties of the drug (Para 0208). Just because Hossainy teaches other options therapeutic agents, it does not disparage or discredit the use of paclitaxel. Thus, a person of ordinary skill could and would combine paclitaxel with PEE to have improved properties and treat the Eustachian tubes as taught by Hossainy and Wang.
Applicant’s arguments filed 09/15/2026, on pages 22-25, regarding Wang, Scopton, and Cordray failing to teach all of the limitations of claim 16 have been fully considered not persuasive. As detailed in the rejection of claim 16 above, Scopton teaches a stiffening member (36, Fig 1) disposed within the balloon catheter proximal to the access port to increase the longitudinal strength and rigidity of the catheter to facilitate insertion of the device into body lumens (Para 0020).
Applicant’s arguments filed 09/15/2026, on pages 25-27, regarding Sweeney’s interchangeable tips is disclosed in a modular guidewire system not a sinus seeker have been fully considered, but is not persuasive. One of ordinary skill in the art understands that depending on the sinus being treated, a different orientation of the tip is necessary (Para 0020 -Cordray). Sweeney and Carter are relied on to teach that it would be obvious to provide alternative tips with different orientation/shapes that can be easily coupled to the sinus seeker/positioning member depending on the procedure being performed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
