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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) filed 7/6/26 have been considered but are moot because the new ground of rejection (necessitated by the amendment) does not rely on all references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 21, 36, 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Campbell et al. 2015/0202089.
Campbell et al. discloses the invention as claimed comprising: A method of treating a patulous Eustachian tube, the method comprising: (a) inserting a first implant (1900) within a first pocket of tissue in a region of tissue external to and adjacent to the patulous Eustachian tube; and (b) expanding the first implant within the first pocket to thereby mechanically urge the Eustachian tube toward a closed state (See [0278] which states “…Alternatively, the stent 1900 may be configured to apply a minimal force against the Eustachian tube ET wall in order to provide mechanical assistance thereto…” and see claim 5 of Campbell et al.)
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.
Claim(s) 22, 25, 27-34, are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. 2015/0202089 in view of Palushi et al. 2020/0069472.
Regarding claims 22, Campbell et al. has been disclosed supra however, Campbell et al. does not utilize the term “pocket”.
Campbell et al. does however disclose the use of a delivery catheter for insertion of the implant thus it is obvious that a “pocket” is created within the tissue.
Regarding claim 25 and 27-29, Campbell et al. does not specifically state that incision is made into the wall of a nasopharynx region. Palushi et al. teaches in [0038 that " First, as shown in FIG. 4B, an operator may advance a deployment mechanism. " obvious that an incision must be made before the advancement can occur. It is further obvious because Pulushi et al states that the advancement is made transnasally (this includes the nasopharynx region) or transorally into ET (26) via the pharyngeal ostium (28; note that the pharyngeal ostium is a specific opening within the lateral wall of the nasopharynx). Thus, it would have been obvious to one having ordinary skill in the art to make an incision in this region in the invention of Campbell et al. in order to deliver the implant against the adjacent wall of the patulous ET.
Regarding claims 29-31, Campbell et al. further discloses that the implant is a wire expandable stent structure (see fig. 19A and [0280]) and it is obviously capable of being resiliently biased to expand, the act of expanding the first implant within the first pocket comprising allowing the first implant to resiliently expand.
Regarding claims 32-34 Campbell et al. discloses the use of endoscopic delivery (see [0289-02292] which state in part “…In some embodiments, an endoscope may be attached to or incorporated into a dilation catheter (or other treatment catheter) or a guide catheter. FIGS. 23A-23C show two embodiments of endoscopes attached to guide catheters. FIG. 23A shows a guide catheter 2300 disposed in a nasal cavity NC with its distal end near a Eustachian tube ET…”), thus it is obvious that Campell is capable of performing the steps as recited.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,833,013 (hereafter '013) in view of Campbell et al. 2015/0202089.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Current application claim 21 recites:
"21. (New) A method of treating a patulous Eustachian tube, the method comprising: (a) inserting a first implant within a first pocket of tissue in a region of tissue near the patulous Eustachian tube; and (b) expanding the first implant within the first pocket to thereby urge the Eustachian tube toward a closed state."
Patent '013 claim 1 recites :
"1. A method of treating a patulous Eustachian tube, the method comprising: (a) forming a first pocket in a wall of a nasopharynx region proximate to a pharyngeal ostium; (b) inserting a resiliently biased implant within the first pocket; and (c) allowing the implant to expand within the first pocket to thereby urge the Eustachian tube toward a closed state."
It is obvious to one having ordinary skill in the art that the subject matter of the current application claim is recited by the patent in a varied manner and that the pat, claim 1 further requires "in a wall of the nasopharynx region. However, the patent claims do not recite “external to and adjacent to the patulous Eustachian tube. Campbell et al. teaches that a stent may be configured to apply a minimal force against the Eustachian tube wall. [0278]). It would be obvious to modify pat. ‘013 to insert a first implant to a region external to and adjacent to the patulous ET in order to urge the ET to close.
Regarding claims 22, see pat. '013 claim 1 which recites (a) forming a first pocket in a wall of a nasopharynx region proximate to a pharyngeal ostium which is considered "the tissue".
Regarding claim 23, see patent '013 claim 6; Regarding claim 24, see pat. '013 claim 7; Regarding claim 25, see pat. '013 claim 8; Regarding claim 26, see pat. claim Regarding claim 27, see pat. claim 1; Regarding claim 28, see pat. claim 8; Regarding claim 29, see pat. claim 1; Regarding claim 30 and claim 31 see pat. claims 2 and 3; Regarding claim 32, see pat. claim 4; Regarding claim 33, see pat. claim 5; Regarding claim 34, see pat. claim 18; Regarding claim 35, see pat. claim 17; Regarding claim 36, see pat. claim 19 and obviousness explanation as give supra in para. 9.
Regarding claims 37-40, pat. '013 does not specifically recite forming a second for "a wire", however it is obvious to one having ordinary skill in the art that the patent recites forming a second pocket for "an implant" (see pat. claims 17, 19) and it is obvious that the wire is an implant.
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 Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 September 22, 2026
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