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) 25-35 have been considered but are moot because the new ground of rejection does not rely all of the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 Wang et al. 2012/0046756 in view of Chang et al. 2006/0210605.
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Noting figures 4 and 7A-B Wang 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 (see figures 3A-3C and [0010; 0021]). Wang et al. further discloses that and expandable stent may comprise a plurality of polymer filaments (see [0011;0042-0043] see list of elastomeric polymers) and be coated with elastomeric polymers (see [0058] which states “… In additional embodiments, the stent can further include an additional coating layer that includes a drug….The additional medicated coating layer can be a hydrogel or an elastomer with a drug dispersed therein…”. and may further comprise mometasone furoate (see [0070-0071 for the use of mometasone furoate) said tubular scaffold having first and second open ends (this is inherent).
The intended use recitation language “..said elastomeric coating applying a force to the scaffold that acts in favor of radial expansion” carries no weight in the absence of any distinguishing structure. Wang et al. discloses the structure as claimed and is thus capable of performing the functions. See MPEP 2114.
However Wang et al. does not specifically disclose the method of 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 Wang et al. and deliver the scaffold to a modified sinus of a subject as taught by Chang et al. in order to treat any inflammation or infection of the paranasal sinuses caused by bacteria, viruses, fungi (molds), allergies or combinations thereof.
Claim 35 is rejected under 35 U.S.C. 103 as being obvious over Wang et al. in view of Chang et al. 2006/0210605 and further in view Makower et al. 2005/0240147. Wang 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 Wang 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.
Claim(s) 25-27, 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Yaniv et al. 2018/0360626 in view of Wang et al. 2012/0046756 and further in view of Chang et al. 2006/0210605.
Regarding claims 25-26, 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 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 the ethmoid sinuses (see figure 46A). However Yaniv et al. does not specifically state the term “elastomer”. Wang et al. teaches 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 figures 3A-3C and [0010; 0021]). Wang et al. further discloses that stent may comprise a plurality of polymer filaments (see [0011;0042-0043] see list of elastomeric polymers) and be coated with elastomeric polymers (see [0058] which states “… In additional embodiments, the stent can further include an additional coating layer that includes a drug….The additional medicated coating layer can be a hydrogel or an elastomer with a drug dispersed therein…”. and may further comprise mometasone furoate (see [0070-0071 for the use of mometasone furoate) said tubular scaffold having first and second open ends (this is inherent). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention Yaniv et al. and utilize a stent with polymer filaments coated with an elastomeric coating in order to provide a scaffold which can resist and recover from deformation produced by force during the implantation process.
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]);
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.
The intended use recitation language “..said elastomeric coating applying a force to the scaffold that acts in favor of radial expansion” carries no weight in the absence of any distinguishing structure. See MPEP 2114.
Regarding claim 27 see fig. 25 of Yaniv et al. and [0559].
Regarding claims 28-31, are rejected under 35 U.S.C. 103 as being obvious over Yaniv et al. 2018/0360626 in view Wang et al. 2012/0046756, 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. It has been held that a prior art reference must either be in the field of the inventor' s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Palasis teaches the require braided filaments as claimed for an implantable scaffold.
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.
Conclusion
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 April 9, 2026
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