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.
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) and Bloom (US 2013/0158536).
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 compliant balloon ([0123]) 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. Wolf as modified does not disclose the steps of selecting a tissue depth for treatment and adjusting the distance between the electrode pair to treat the tissue at the selected depth. However, Wolf does generally teach that depth of treatment can be controlled ([0131]), and in fact specifically notes that depth can be based on the spacing between the electrodes ([0153]). Bloom discloses a balloon catheter with bipolar electrode pairs and teaches that the inflation of the balloon can be controlled to adjust the spacing between the pairs and thus the depth of treatment provided by the electrodes ([0040]). 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 selecting a depth for treatment as taught by Wolf by adjusting the distance between the electrodes with balloon inflation as taught by Bloom to produce the predictable result of allowing a user to treat tissue at a specific depth.
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, Dimmer and Bloom, 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’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
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