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 filed 10/1/25 have been fully considered but they are not persuasive. The applicant contends that the stent of Hossainy et al. is implanted into a Eustachian tube and not into a sinus.
The examiner points out that the claims are rejected under 103 Hossainy et al. in view of Chang et al. The Hossainy et al. reference is utilized to disclose the limitations of “…a surgically modified sinus space (this is interpreted because once the delivery catheter is routed and implanted within the sinus cavity then the sinus has been modified. See [0105] which discloses the method of sinus dilation.)” Hossainy et al. does further disclose that stents “comprising a plurality of filaments (74) coated with an elastomeric coating (See [0096-0098] which disclose that the stent may be coated with a polymer which is inherently an elastomer) and a layer comprising mometasone furoate (see [0112] which discloses that the stent may be coated with mometasone furoate), said tubular scaffold having first and second open ends (this is inherent)”…” . It is noted that that the Hossainy et al. delivers the stent to a Eustachian tube. Cheng teaches that sinus passages may be modified and then stents may be delivered to the sinus passage (see [0149] which states “a method of dilating a nasal cavity using a working device comprising a balloon catheter with a pressure-expandable stent. In FIG. 4B, an introducing device e.g. a guidewire 416 is introduced into a nasal cavity e.g. an ostium of a sinus. In FIG. 4C, a balloon catheter 418 is introduced over guidewire 416 into the nasal cavity. Balloon catheter 418 comprises a pressure-expandable stent 420…” ). The obviousness of the combination will be further explained below.
The applicant further contends that Chang does not favor FESS, nevertheless Change does teach that it is a well know method in the art (See as evidence further for example by Makower et al. 2006/0063973 [0238]).
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) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Hossainy et al. 2015/0305943 in view of Chang et al. 2006/0210605.
Noting figure 1 below , Hossainy et al. discloses
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A method of treating a subject who has undergone sinus surgery, comprising: providing a subject who has undergone sinus surgery and has a surgically modified sinus space (this is interpreted because once the delivery catheter is routed and implanted within the sinus cavity then the sinus has been modified. See [0105] which discloses the method of sinus dilation.). Hossainy et al. further teaches that stent may comprise a plurality of filaments (74) and be coated with elastomeric polymers (see [0096-0098] which is inherently an elastomer) and may further comprise mometasone furoate (see [0112] which discloses that the stent may be coated with mometasone furoate), said tubular scaffold having first and second open ends (this is inherent). Hossainy et al. also teaches removing all or a portion of a tumor; removing a polyp [0022]; and also teaches implantation of stents [0023; 0039; 0149].
However Hossainy et al. does not specifically describe methods of placing the stent into a sinus or that the modified surgery has a surgically modified sinus space created by the removal of bone and tissue to enlarge sinus outflow tracts.
Chang et al. teaches methods of placing stents into a sinus cavity FESS (Functional Endoscopic Sinus Surgery noting that this is a well-known technique as further evidenced for example by Makower et al. 2006/0063973 [0238]) by using an endoscope is inserted into the nose and, under visualization through the endoscope, the surgeon may remove diseased or hypertrophic tissue or bone and may enlarge the ostia of the sinuses to restore normal drainage of the sinuses (see [0014]). Chang et al. further states in [0149] that a variety of fabrication methods can be used for fabricating a stent.
It would have been obvious to one having ordinary skill in the art to take the polymer coated stent which comprises mometasone furoate of Hossainy et al. and deliver the scaffold to a modified sinus of a subject as taught by Chang et al. and to use the FESS technique in order to treat any inflammation or infection of the paranasal sinuses caused by bacteria, viruses, fungi (molds), allergies or combinations thereof.
Claim(s) 25-27, 31, 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Yaniv et al. 2018/0360626 in view of Chang et al. 2006/0210605.
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Yaniv et al. discloses a method of treating a subject who has undergone sinus surgery, comprising: providing a subject who has undergone sinus surgery and has a surgically modified sinus space (this is interpreted because once the delivery catheter is routed and implanted within the sinus cavity then the sinus has been modified) and a tubular scaffold (e.g. 1690) comprising a plurality of filaments (See fig. 16-17 and elements 1612a; 1614a) coated with an elastomeric coating (see [0026-0027]; and a layer comprising mometasone furoate (see [0263]), said tubular scaffold having first and second open ends (see figure 16), and delivering said scaffold to said surgically modified sinus space of said subject under conditions where the scaffold delivers said mometasone furoate to said subject (see figure 46A).
Claim(s) 35 is rejected under 35 U.S.C. 103 as being unpatentable over Yaniv et al. 2018/0360626 in view of Chang et al. 2006/0210605 and further in view of Makower et al. 2005/0240147. Yaniv et al. and Chang et al. have been disclosed however do not specifically state that the stent is self-expandable. Makower et al. teaches that self-expandable stents may be implanted in a nasal passage which are not pressure expandable (see [0198]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Yang et al. and utilize a self-expanding stent in lieu of a pressure stent in order to provide a spring or self-expand to a radially expanded configuration in which it frictionally engages the surrounding anatomical structure and thus saving time during the surgical procedures.
Yaniv et al. further discloses that the shape memory implant may be self-expandable and the use of Nitinol materials which are well known to exhibit self- expandable properties (see [0413]).
Regarding claim 26 see figure 46A and [0108; 0222]. Regarding claim 27 see figure 25 and [0082]. Regarding claim 33 see [0122; 0289].
However, Yaniv et does not disclose that the modified surgery has a surgically modified sinus space created by the removal of bone and tissue to enlarge sinus outflow tracts.
Chang et al. teaches FESS (Functional Endoscopic Sinus Surgery) by using an endoscope is inserted into the nose and, under visualization through the endoscope, the surgeon may remove diseased or hypertrophic tissue or bone and may enlarge the ostia of the sinuses to restore normal drainage of the sinuses (see [0014]); Hossainy et al. also teaches removing all or a portion of a tumor; removing a polyp [0022]; and also teaches implantation of stents [0023; 0039; 0149]. Chang et al. further states in [0149] that a variety of fabrication methods can be used for fabricating a stent.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Yaniv et al. and use the stent/scaffold structure with the FESS technique as taught by Chang et al. in order to further dilatate the nasal cavity and treat sinusitis.
Claims 28-30 are rejected under 35 U.S.C. 103 as being obvious over Yaniv et al. 2018/0360626 in view of Chang et al. 2006/0210605 and further in view of Palasis et al. 2014/0100644.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Yaniv et al. and Chang et al. have been disclosed supra and further discloses that the diameter of the scaffold is between 10 and 38 mm. However Yaniv et al. does not disclose that the braided scaffold comprises 16 or 32 filaments.
Palasis, teaches that braided stents (See paragraph 3), may have 16 or 32 filaments; see paragraphs 19, 15, and 14. It would have been obvious to one of ordinary skill in the art to modify the invention of Yaniv et al. manufacture the braided stent embodiment to 16 or 32 filaments because the by counting the filaments in figure 25 of Yaniv et al. 16 or 32 filament are present.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claims 30-32, Yaniv et al. discloses treating sinus with devices that have different diameter by virtue of the shape shown in Figures 3, 3A, 4, and 4A but does not disclose the particular diameters claimed. However, the mere recitation of a dimension is not considered unobvious if that dimension does not result in some characteristic that is distinct from other devices of unspecified dimensions utilized in the same manner in the same treatment site; see MPEP 2144.04 IV. A.
Claim 35 is rejected under 35 U.S.C. 103 as being obvious over Yaniv et al. 2018/0360626 in view of Chang et al. 2006/0210605 and further in view Makower et al. 2005/0240147.
Yaniv et al. 2018/0360626 in view of Chang et al. 2006/0210605 have been disclosed however do not specifically state the use of a self-expandable stent. Makower et al. teaches that self-expandable stents (768) may be deployed to nasal passages (see [0198]). It would have been obvious to one having ordinary skill in the art to modify the invention of Yaniv et al. and utilize a self-expandable stent in order to provide a spring action to a radially expanded and frictionally engage with the surrounding anatomical structure and to save time during the surgical procedure further Yang envisions utilizing a shape memory materials such as Nitinol (see [0026; 0058; 0071
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 December 16, 2025