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 .
Election/Restrictions
Applicant’s election without traverse of Group I and Species A in the reply filed on 6/23/2026 is acknowledged. Claims 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/23/2026. The requirement is deemed proper and is therefore made FINAL.
Claim Objections
Claim 8 is objected to because of the following informalities: a grammatical error in the phrase “comprising plural projections or projections.” Appropriate correction is required.
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) 1-2, 4, 6, 8-10, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hingston et al. (Pub. No.: US 2019/0076274 A1; hereinafter “Hingston”).
Hingston discloses the following regarding claim 1: a stent (10) for a respiratory organ (paras. 0057-0059), the stent having an inside surface (interior surfaces) and an outside surface (exterior surfaces), wherein: the stent comprises a base member (36) and a hydrophilic polymer layer (38); the hydrophilic polymer layer contains a hydrophilic polymer having a hydroxy group and an amide group (paras. 0083-0084); and the hydrophilic polymer layer is provided on at least a part of the inside surface (Fig. 2).
Hingston discloses the following regarding claim 2: a stent (10) for a respiratory organ (paras. 0057-0059), the stent having an inside surface (interior surfaces) and an outside surface (exterior surfaces), wherein: the stent comprises a base member (36) and a hydrophilic polymer layer (40); the hydrophilic polymer layer contains a hydrophilic polymer having a hydroxy group and an amide group (paras. 0083-0084); and the hydrophilic polymer layer is provided on at least a part of the outside surface (Fig. 2).
Hingston discloses the following regarding claim 4: the stent according to any one of claim 1, comprising a mixed layer (areas where elements 36, 38 overlap) of a component of the base member and a component of the hydrophilic polymer layer (Figs. 3-4C), the mixed layer being disposed between the base member and the hydrophilic polymer layer (Figs. 3-4C).
Hingston discloses the following regarding claim 6: the stent according to claim 1, comprising a tubular structure portion (Fig. 2).
Hingston discloses the following regarding claim 8: the stent according to claim 1, comprising plural projections or projections (42) and recesses (44) on the outside surface (Figs. 3-4C).
Hingston discloses the following regarding claim 9: the stent according to claim 1, wherein the respiratory organ is a trachea, bronchus, or lung (paras. 0057-0059).
Hingston discloses the following regarding claim 10: the stent according to claim 1, wherein the hydrophilic polymer having a hydroxy group and an amide group is at least one polymer selected from the group consisting of polyamides having a carboxyl group and copolymers of a monomer having a hydroxy group and a monomer having an amide group (paras. 0083-0084).
Hingston discloses the following regarding claim 12: the stent according to claim 10, wherein the monomer having an amide group is at least one monomer selected from the group consisting of N-vinylpyrrolidone, N-vinylacetamide, N, N-dimethylacrylamide, N, N-diethylacrylamide, N- isopropylacrylamide, N-(2-hydroxyethyl)acrylamide, and acrylamide (para. 0084).
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) 3 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hingston in view of Christakis et al. (Pub. No.: US 2015/0342760 A1; hereinafter “Christakis”).
Hingston discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the base member containing a silicone resin; and the coating layer having a hydroxy group is at least one monomer selected from the group consisting of methacrylic acid, acrylic acid, vinylbenzoic acid, thiophen-3-acetic acid, 4-styrenesulphonic acid, vinylsulphonic acid, 2- acrylamide-2-methylpropane sulfonic acid, and their salts. Christakis teaches that it is well known in the art that a stent comprises a base member containing a silicone resin and a layer having a hydroxy group is at least one monomer selected from the group consisting of methacrylic acid, acrylic acid, vinylbenzoic acid, thiophen-3-acetic acid, 4-styrenesulphonic acid, vinylsulphonic acid, 2- acrylamide-2-methylpropane sulfonic acid, and their salts (paras. 0036-0042), for the purpose of providing the stent with the desired mechanical and biocompatible characteristics needed to best suit the implantation site. It would have been obvious to one having ordinary skill in the art to modify the stent of Hingston to comprise the materials taught by Christakis, in order to provide the stent with the desired mechanical and biocompatible characteristics needed to best suit the implantation site. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case, replacing one type of stent and layering material for another, is generally considered to be within the level of ordinary skill in the art.
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hingston.
Hingston discloses the limitations of the claimed invention, as described above. It further recites the tubular structure portion having the claimed diameter values (para. 0066). However, it does not explicitly recite the values of the thicknesses of the tubular structure, the hydrophilic polymer layer, and the base member. The optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the thickness dimensions of the stent and its layers needed to achieve the desired results and properly suit the implantation site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the thickness dimensions of the stent and its layers, would have been obvious at the time of applicant's invention in view of the teachings of Hingston. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
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/ANN HU/Primary Examiner, Art Unit 3774
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