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 .
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) 21-22, 25, 27-30, 36 are rejected under 35 U.S.C. 103 as being unpatentable over Palushi et al. 2020/0069472.
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4. Regarding claims 21-22, 29, 36 and noting figure 4A, Palushi et al. discloses a method of treating a patulous Eustachian tube (See [0013; 0018; 0038]), the method comprising: (a) inserting a first implant/wire structure within a tissue in a region of tissue (26) near the patulous Eustachian tube (Fig. 4B); and (b) expanding the first implant/wire structure (see [0040] which states “…when implant (100) is deployed, as shown in FIG. 4C, distal barbs (112) and bio-absorbable spheres (106) are no longer constrained in the compressed position such that barbs (112) and spheres (106) resiliently return toward the natural expanded position.”) within the tissue to thereby urge the Eustachian tube toward a closed state (see figures 4C and fig. 5A). However, Palushi et al. fails to disclose the tissue is a “first pocket”.
Palushi et al. does however disclose “..Sliding sheath (50) is advanced within channel (25) of ET (26)…”, see [0038]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the channel to serve as a first pocket which is created once the delivery device/sheath are inserted into the tissue in order for placement of the implant within a first pocket of tissue.
5. Regarding claim 25 and 27-28, Palushi et al. does not specifically state that incision is made into the wall of a nasopharynx region. It would have been obvious to one having ordinary skill in the art to make an incision in this region because Palushi et al. states 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).
6. Regarding claim 29 see [0040] for resiliently expanding. Regarding claim 30 “comprising a wire structure” see element (112).
7. Claim(s) 31-34, 38 are rejected under 35 U.S.C. 103 as being unpatentable over Palushi et al. 2020/0069472 in view of Palushi et al. 2019/0388662 (hereafter ‘662).
Palushi et al. has been disclosed supra as using a transnasally (this includes the nasopharynx region) or transorally approach. However, does not disclose the first implant comprising a stent and (a) inserting an endoscope through a nostril; and (b) providing visual guidance of a nasopharynx region with the endoscope or inserting an endoscope through a patient's mouth; and providing visual guidance of a nasopharynx region with the endoscope.
Noting [0076], ‘662 teaches “…In use, balloon dilation catheter (300) is advanced through the ear canal (20), for instance under visual guidance using an endoscope (60). In some examples, a guide catheter may be used to aid in accessing the ET (26) with balloon catheter (300) and that a stent may be deployed into the ET [0052].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the methods of Palushi et al. and utilize an endoscope as they are well known in the art for providing visual insights into surrounding tissues. It further would be obvious to modify and utilize a stent with the ET for the purpose of further delivery therapeutic or diagnostic agents [0052].
Double Patenting
8. 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). Although the claims at issue are not identical, they are not patentably distinct from each other.
9. 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.
10. 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”.
11. 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 9; 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.
12. 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 the patent recites forming a second pocket for “an implant” (see pat. claims 17, 19) and it is obvious that the wire in an implant.
Conclusion
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 April 1, 2026
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