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 . 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 27 February 2026 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 15/480,575, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The earliest prior filed application with support for the balloon embodiment shown in figures 8A-B is 16/041,101 filed 20 July 2018 which is therefore the effective filing date of the pending application. See the Response to Arguments below for additional discussion.
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.
Claims 1, 7-17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wolf (US 2014/0316396) in view of Dimmer (US 2012/0310233).
Regarding claims 1, 7, 8, 13-17, 19 and 20, Wolf discloses a method that is nearly identical with the claimed method, being from the same inventors and Applicant. More specifically, Wolf disclose a method of treating poor airflow (for any number of reasons including rhinitis, [0018]), without incision or implant, that includes the step of inserting a treatment element (fig. 4B) into an airway (fig. 7), the treatment device including an elongated shaft with a distal balloon (fig. 4B and 7) having multiple, linear, expandable bipolar RF electrodes attached to the surface of the balloon ([0153], fig. 4B). The method further includes inflating the balloon ([0120]) to place the electrodes in contact with tissue after having inserted the balloon in a deflated configuration ([0153]). Deflating the balloon and removing the treatment element are necessary steps for these types of systems (that is, the device is not left inside a patient). Wolf does not disclose that the electrodes are comprised of multiple, longitudinal electrodes around the circumference of the balloon at regular intervals, forming bipolar pairs, where the electrodes are positioned such that when the balloon is inflated the distance between the electrode pairs increases. However, bipolar electrodes on balloons are common in the art for a wide range of applications and there is no evidence that a particular bipolar electrode configuration produces unexpected results (within the meaning of MPEP 716.02(a)). Dimmer discloses a related medical device comprising a balloon with electrodes for ablation (fig. 10) and teaches that a plurality of longitudinal electrodes (229) can be located on the balloon such that adjacent electrodes form bipolar pairs ([0122]) that will move apart when the balloon is inflated (because the electrodes are not connected to each other on the balloon). It has been held that the simple substitution of one known element for another is an obvious modification (MPEP 2141(III)), where in this case the “known element” is “bipolar electrodes.” Alternatively, it has also been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the Application was filed, it would have been obvious to modify the apparatus used to perform the method of Wolf to include any commonly known electrode configuration, including longitudinal, bipolar pairs of electrodes independently spaced around the circumference of the balloon as taught by Dimmer, that would produce the predictable result of allowing a user to ablate tissue in a desired manner.
Regarding claims 9-12, the embodiment of Wolf discussed above does not disclose that the energy is used to modify tissue either to create a concave shape or to stiffen tissue. However, in other embodiments Wolf does teach that treatment device can be used to create a concave shape in the cartilage of the nose ([0175]), and more generally teaches that energy can be used to reshape, remodel or strengthen submucosal tissue, where strengthening tissue is understood to include increasing the stiffness of tissue (claim 1, note also tightening in [0126] and [0154], and inadequate stiffness in [0013]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the method of Wolf to include any steps commonly known to improve airflow, such as the various ways of remodeling of the nasal tissue as taught by Wolf, that would produce the predictable result of treating a patient in a desired manner to produce a desired result.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Wolf and Dimmer, further in view of Palushi (US 2019/0357927).
Regarding claim 2, the method of Wolf does not disclose breaking the turbinate. Palushi discloses a method of improving airflow ([0059]) that involves breaking the turbinate by inflating a balloon ([0051]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the method of Wolf to include any step known to improve airflow, including breaking the turbinate with a balloon as taught by Palushi, that would produce the predictable result of alleviating symptoms of a patient.
Response to Arguments
Applicant has amended the claims to correct various issues and to remove a reference to nerve ablation in an attempt to give the claims an older effective filing date. Removing the reference to nerves does address the original analysis regarding the effective filing date. However, the original claims were more generically directed to a balloon, while the currently pending claims are clearly directed to the balloon embodiment shown in figures 8A-B. Note in particular the claim language regarding the circumferentially spaced electrodes that move apart as the balloon is inflated. Further, Applicant’s reference in the remarks to paragraph [0115] for support for the amendments, the paragraph that discusses these figures, is more evidence that Applicant considers this embodiment to be in view. Those figures and the associated discussion were introduced in the same application that introduced the discussion of nerve ablation, so that the effective filing date of the pending claims remains the filing date of application 16/041,101: 20 July 2018. It is noted that there have been patents issued with respect to the balloon embodiment shown in Applicant’s figure 4B which has an effective filing date of 14 June 2011 as explained, for example, in the Notice of Allowance filed 12 September 2019 in application 16/433,909 (which has terminal disclaimers over US patent 10,028,780, from application 15/480,575, and US patent 10,722,282, from application 16/041,101). To the degree the pending claims are directed to the embodiment of figures 8A-B, there are no double patenting issues because the balloon embodiments are distinct. Any amendment that shifts the claims to the embodiment shown in figure 4B will likely have substantial double patenting issues due to the other applications directed to that embodiment as a result of the much earlier filing date.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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, Joseph Stoklosa can be reached on 571-272-1213. 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.
/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
Prosecution Insights