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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Claims 16-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/26/25.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4,6-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In claim 1, lines 2-3 the recitation of “braided mesh frame and a silicone body molded on the braided mesh frame” implies the mesh has on its (exterior) surface the silicone body. However, in lines 5,6 claim 1 then recites the “braided mesh frame circumferentially covers the silicone body” to then imply the mesh is on the surface of the silicone body. Thus, there is ambiguity that these two limitations imply two different arrangements of the mesh frame relative to the silicone body. Both cannot be required in the claim, it is either one way or the other with the silicone body on the exterior of the frame or the silicone body on the interior surface of the frame. which arrangement of elements is intended to be required?
The term “periphery” in claim 11 is a relative term which renders the claim indefinite. The term “periphery” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not understood where or what arrangement the silicone body is with respect to the braided mesh frame because is “periphery” meaning an exterior surface? Or is it meaning an end? However, what is noteworthy is as mentioned already, claim 1 has ambiguity but recited the braided mesh frame is covering the silicone body or exterior to it. Thus this silicone body arrangement being fixed to a periphery to the braided mesh frame implies the opposite of claim 1, as this could mean exterior surface so it that what is meant? Note, this would be improper as it is switching embodiments.
Dependent claims carry the same issue as the independent claim they depend on.
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) 1-4,6-11,14,15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clerc et al. (WO 2009/091899). Please note claim(s) 1 is interpreted with the mesh frame being on the silicone body. Clerc et al. disclose a silicone stent for trachea, page 7, lines 15-18. Figs. 6,7 show a stent body (16), wherein the stent body comprises a braided mesh frame (42,44) and a silicone (page 19 ,line 4, page 20, lines 9-11,16) body (40) molded on the braided mesh frame (16); a circumferentially sealed space (inner lumen) is defined within the silicone body (40); a distal end and a proximal end of the silicone body (40) respectively have a distal-end opening and a proximal-end opening that communicate with the space (inner lumen); the braided mesh frame (42) circumferentially covers the silicone body (40), and runs in an axial direction of the silicone body (40); and the braided mesh frame (16) extends from the proximal end of the silicone body to the distal end of the silicone body. Clerc et al. further disclose (page 10, lines 16-18) the silicone stent is configured to be received in an accommodation cavity (lumen of delivery device) of a delivery device in a contracted state, and to be released and implanted in the trachea by the delivery device. Regarding claim 2, Clerc et al. also disclose (page 8 ,lines 8-17) there can be a plurality of protrusions on the outer peripheral wall of the stent body. Regarding claims 3,4 Clerc et al. show (Figs. 1,2,4) that the protrusion can be integrally formed with the silicone body as there is variation in surface diameters and features, such that the braid is film coated, see also Fig. 5. Regarding claim 6, it can be seen (Fig. 1) Clerc et al. shows a stent body 20 with the plurality of protrusions (30) comprise a plurality of columns of protrusions (30) that are uniformly distributed along a circumferential direction of the stent body (20), and each column of protrusions (30) comprise a plurality of protrusions disposed at intervals along an axial direction of the stent body (20). With respect to claim 7, it can be construed that the plurality of protrusions are distributed dispersedly on the stent body as seen in Fig. 1 of Clerc since the protrusions are placed in three sections on the body. Regarding claim 8, Clerc et al. disclose (page 9, lines 4-6) that the thickness of the protrusion falls within the range of 0.5 mm to 4mm. With respect to claim 9, Clerc et al. disclose (page 18, lines 13-15) the wall thickness of the stent body which is coated can be within the range of 0.05mm to 0.8 mm. Regarding claim 10, Clerc et al. also disclose (page 18, lines 15-18) the silicone body is coated on the braided mesh frame with a silicone film. Regarding claim 11, as best understood the silicone body is fixed at a “periphery” of the mesh frame (see Figs. 4,5) and is covering the wires that can be braided. With respect to claim 14, Fig. 4 shows the stent body (10) further comprises a silicone (page 20) layer 40 wrapping the braided mesh frame (44), and the silicone body (20) is fixedly connected to the silicone layer. With respect to claim 15, it must be noted claims are given their broadest reasonable interpretation and in this instance, a delivery device is any instrument that receives the stent body and since Clerc states (page 10, lines 17,18) the stent device is compressed and placed within a delivery device, it inherently has an “accommodation cavity” which can be construed as a sheath or catheter that receives the stent body.
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) 12,13 are rejected under 35 U.S.C. 103 as being unpatentable over Clerc et al. (WO 2009/091899). Clerc et al. is explained supra. However, Clerc et al. did not show the embodiment of braided mesh frame with skirts. Figs. 3,12 show the stent body (10) further comprises skirt edges (36,37) connected at two ends of the silicone body (20); and along an axial direction of the silicone stent, the skirt edges are located on two sides of the mesh frame. Additionally as seen in Fig. 3 the skirt edge (36,37) is integrally formed with the silicone body (20). Thus, it would have been obvious to one of ordinary skill in the art to provide the stent embodiment with the silicone body and braided mesh frame covering the silicone body to provide the ends with a skirt at each end and being integrally formed with the silicone body since it provides the flexible ends allowing to be compressible if needed for engagement with the lumen of a vessel, page 7, lines 14-18.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Burton (CA 2020957) disclose a stent delivery system with a braided stent on a silicone body.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799