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 01/23/2026 have been entered. Claims 1-16, 18-20 are pending in the application. Applicant' s amendments to the claims have not overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 11/05/2025.
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 7-14 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 7, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, the limitation will be interpreted as part of the claimed invention.
Claims 8-14 are rejected as depending from a rejected claim.
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 1-3, 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2019/0015639) in view of Mayse (US 2023/0075851).
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, 0123).
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 inserting the balloon catheter into airways distinct from the trachea or sinus (i.e. likely the bronchus) is silent regarding the target site is in a mainstem bronchus, bronchus intermedius, lobar bronchus, segmental bronchus, or sub-segmental bronchus.
Mayse teaches an analogous method of treating a COPD (0002-0003) comprising inserting a drug-coated balloon catheter into a target site in a mainstem bronchus, bronchus intermedius, or lobar bronchus (Para 0081, 0093).
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 mainstem bronchus, bronchus intermedius, or lobar bronchus as taught by Mayse in order to have a method that can treat obstructions in those portions of the airway (0031).
Regarding Claim 2, the modified invention of Wang and Mayse 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 and Mayse 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 0131, 0144, 0214 -Wang).
Regarding Claim 5, the modified invention of Wang and Mayse 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 and Mayse 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 and Mayse teaches the disclosed steps and structure, one of ordinary skill in the art would understand that the method disclosed by Wang and Mayse 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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2019/0015639) in view of Mayse (US 2023/0075851).
Regarding Claim 4, the modified invention of Wang and Mayse 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).
Claims 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2019/0015639) in view of Stankus (US 2020/0230373).
Regarding Claim 7, Wang discloses a method of treating chronic rhinosinusitis (CRS) or chronic rhinosinusitis with nasal polyps (CRSwNP) in a human subject (Para 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, 0123); 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).
Wang is silent regarding performing at the target lesion surgical dissection, irrigation, or balloon dilation with an uncoated balloon
Stankus teaches an analogous method of treating chronic rhinosinusitis (Para 0013) comprising: identifying a target lesion in a paranasal sinus or sinus drainage pathway; performing at the target lesion surgical irrigation (Para 0060); inserting a drug-coated balloon catheter into the target lesion, wherein the balloon is coated with a coating layer comprising a therapeutic agent (Para 0079, 0123).
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 the step of irrigation as taught by Stankus in order to enhance drug release from the expandable member (Para 0060).
Regarding Claim 8, Wang discloses the balloon is soaked in saline or water for prior to insertion to hydrate the coating (Para 0249), 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 Stankus 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 Stankus 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 11, the modified invention of Wang and Stankus discloses 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 0131, 0144, 0214 -Wang).
Regarding Claim 12, the modified invention of Wang and Stankus 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 Stankus 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 Stankus teach the disclosed steps and structure, one of ordinary skill in the art would understand that the method disclosed by Wang and Stankus 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 13, the modified invention of Wang and Stankus discloses the therapeutic agent is measurable in blood of fewer than 25% of patients at any time point following treatment (As the claim states “any time point”, the “time point” can be interpreted to be a time such as multiple days after treatment when paclitaxel would for sure no longer be in the blood)(Further, Examiner notes that the method disclosed by Wang and Stankus 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 Stankus teach the disclosed steps and structure, one of ordinary skill in the art would understand that the method disclosed by Wang and Stankus 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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2019/0015639) in view of Stankus (US 2020/0230373) and further in view of Becker (US 2004/0064150).
Regarding Claim 14, the modified invention of Wang and Stankus 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; inserting the balloon catheter into the resected ethmoid cavity; inflating the balloon to reshape and flatten residual bony partitions; and deflating and removing the balloon
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; inserting the balloon catheter into the resected ethmoid cavity; inflating the balloon to reshape and flatten residual bony partitions; and deflating and removing the balloon (Para 0050).
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 Stankus (US 2020/0230373) and further in view of Hossainy (US 2015/0305943) and further in view of Wang (US 2019/0015639).
Regarding Claim 15, Stankus discloses a method of treating a eustachian tube disorder in a human subject (Para 0014), the method comprising: inserting a balloon catheter into the eustachian tube (Para 0105), wherein the balloon is coated with a coating layer comprising a therapeutic agent and one or more additives; inflating the balloon to dilate the eustachian tube and deliver the therapeutic agent to the tissue; deflating the balloon; and withdrawing the balloon catheter (Para 0123).
Stankus is silent regarding wherein the therapeutic agent comprises paclitaxel, sirolimus, or a derivative thereof, and wherein the one or more additives comprise pentaerythritol ethoxylate (PEE).
Hossainy teaches a method of treating a eustachian tube disorder in a human subject (Para 0010) wherein paclitaxel is used as a therapeutic agent that reduces inflammation in the eustachian tube (Para 0108).
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).
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 of the balloon disclosed by Stankus to have a therapeutic agent comprising paclitaxel and an additive comprising pentaerythritol ethoxylate as Hossainy teaches that paclitaxel is a known drug that reduces inflammation in the eustachian tubes and 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 (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 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 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 an access port and positioning instrument as taught by Scopton in order to facilitate positioning of the balloon catheter at the target site and allow for a shorter positioning instrument (Para 0003, 0005, 0017).
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, 0123 -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 port in the distal end 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 01/23/2026, on page 8, regarding the use of “optionally” in claim 7 does not render the claim indefinite have been fully considered but is not persuasive. Using “optionally” in a claim makes it unclear if the limitation is a required part of the claim or not. The current rejection of claim 7 is interpreting the claim as if “optionally” is not recited and therefore Wang does not read on all of the claim limitations. However, if the term optionally remains in the claim, it can also be interpreted to not require the limitation “performing at the target lesion surgical dissection, irrigation, or balloon dilation with an uncoated balloon” and be rejected as an anticipation rejection in view of Wang. Therefore, it is currently unclear if Applicant is intending for the limitations after the term “optionally” to be a required claim element and thus the 112(b) rejection remains.
Applicant’s arguments filed 01/23/2026, on pages 8-9, regarding Wang failing to teach the target site is a mainstem bronchus, bronchus intermedius, lobar bronchus, segmental bronchus, or sub-segmental bronchus have been fully considered but are moot in view of the current rejection that relies on Mayse to teach the target site.
Applicant’s arguments filed 01/23/2026, on pages 9-10, regarding Stankus failing to teach the therapeutic agent comprises paclitaxel, sirolimus, or a derivative thereof, and wherein the one or more additives comprise pentaerythritol ethoxylate (PEE) have been fully considered but are moot in view of the current rejection that relies on Hossainy and Wang to teach that paclitaxel can be used to treat a eustachian tube and PEE can be used as an additive to paclitaxel.
Applicant’s arguments filed 01/23/2026, on pages 11-14, regarding Wang not teaching treating the specific disease conditions have been fully considered but are not persuasive. It has been held that statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art (MPEP 2111.02(II)). Claim 7 provides an intended use (i.e. treating CRS or CRSwNP), however, the intended use does not provide any structural or manipulative differences to the claimed invention. Wang and Stankus teach each and every one of the method steps and therefore, would be suited for the intended purpose. Applicant also argues that Stankus teaches away from using paclitaxel or sirolimus for sinus conditions. Stankus, in fact, does not teach away from using paclitaxel or sirolimus. Simply providing preference drugs does not teach away from using another drug as it doesn’t criticize, discredit, or otherwise discourage the solution claimed (MPEP 2123(II)). Therefore, Wang and Stankus teach all of the limitations of claim 7.
Applicant’s arguments filed 01/23/2026, on pages 11-14, regarding Becker providing no teaching, suggestion, or motivation to combine ethmoidectomy procedure with a subsequent treatment with a drug-coated balloon have been fully considered but are not persuasive. As detailed in the rejection of claim 14 above, incorporating an ethmoidectomy into the method provides the added benefit of restoring the patency of the sinus by enlarging the opening (Para 0008 -Becker). Therefore, there is ample motivation. Further, surgical procedures are often combined when the procedures are being performed in the same location as to reduce the patient exposure to anesthesia and other side effects of surgery. It is well within the skill of one in the art to combine 2 sinus surgeries to have the benefit of both individually and reduce patient risk of adverse effects.
Applicant’s arguments filed 01/23/2026, on pages 15-18, regarding Wang and Scopton failing to teach a positioning instrument having a sinus seeker tip with a preconfigured tip shape and attached to a handle have been fully considered but are moot in view of the current rejection that relies on Cordray to teach a sinus seeker tip.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783