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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5 and 7 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Venkatraman at al. (2018/0042742) “Venkatraman”.
Regarding claim 1, Venkatraman discloses a stent graft 20 (Figs. 1 and 3 disclose stent and polymer coating combination), comprising: a base stent 20 having a first and a second longitudinal end (end sections 21 and 23; Fig. 1), a lumen extending longitudinally through the base stent20 (par. 0004 and Fig. 1 disclose a stent for drainage which would inherently comprise a lumen), a covering material 30 provided so as to line the base stent 20 ( par. 0050 discloses the stent is covered by a polymer coating), the base stent 20 having a roughened surface that is at least partially penetrated by the covering material so as to form a positive fit (par. 0094 discloses the stent comprises a textured surface carried out by etching and roughening the stent surface, doing so allows for the covering material to physically bond to the topography or pattern on the stent surface; which would occur by the covering being present within the topography/roughened surface of the stent).
Regarding claim 3, Venkatraman discloses wherein the covering material is provided on the outside of the base stent without covering the inside of the base stent (Fig. 3 discloses the stent cross-section which shows the covering 30 is on an outer surface of the stent and not inside).
Regarding claim 5, Venkatraman discloses wherein the roughened surface has been roughened by sandblasting (par. 0094 discloses the stent has a roughened surface).
Furthermore, the claimed phrase “roughened by sandblasting” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
Regarding claim 7, Venkatraman discloses wherein the stent graft comprises holes 27 that penetrate through the base stent (Fig. 1 and par. 0020).
Claims 1, 3 and 5 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Herweck et al. (2004/0253185) “Herweck”.
Regarding claim 1, Herweck discloses a stent graft 12 (Figs. 2C and par. 0009 discloses the combination of a stent and a bonded polymeric material) comprising: a base stent 12 having a first and a second longitudinal end (end sections of stent 12; Fig. 2C), a lumen extending longitudinally through the base stent 12 (par. 0013 discloses coronary stent which would inherently comprise a lumen), a covering material 40 provided so as to line the base stent 12 (par. 0009 discloses the stent is covered by a polymer covering material), the base stent having a roughened surface that is at least partially penetrated by the covering material so as to form a positive fit (par. 0009 discloses the stent has wells or holes that allow for the polymer material to be bonded to the metal surface).
Regarding claim 3, Herweck discloses wherein the covering material is provided on the outside of the base stent without covering the inside of the base stent (pars. 0005 and 0092 discloses covering the outer surface of the stent and does not mention covering the inside of the stent).
Regarding claim 5, Herweck discloses wherein the roughened surface has been roughened by sandblasting (par. 0009 discloses the stent has a roughened surface due to wells or holes that allow for the polymer material to be bonded to the metal surface).
Furthermore, the claimed phrase “roughened by sandblasting” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
Claims 1, 2, 4-6 and 8-12 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Hossainy et al. (6979346) “Hossainy”.
Regarding claims 1 and 8, Hossainy discloses a stent graft (Fig. 9 discloses stent 400 and Fig. 7A discloses the combination of the stent and covering 401) and a method of making a stent graft (Fig. 8), comprising: providing a base stent 400, the base stent having a first and a second longitudinal end and a lumen extending longitudinally therethrough (as shown in Fig. 9), a covering material 401 provided so as to line the base stent 400 (Fig. 7), the base stent having a rough surface 314 facing the lumen (Figs. 8-9 and col. 7, lin. 50-54 disclose inner surface 410 having asperities 314), arranging a tubular covering material 401 inside the base stent 400 and causing it to at least partially penetrate into the rough surface so as to form a positive fit (Fig. 7A and col. 7, lin. 16-21 disclose the tubular inner surface of the stent comprises covering 401 where the covering extends into the rough surface or asperities).
Regarding claim 2, Hossainy discloses wherein the covering material is provided on the inside of the base stent without covering the outside of the base stent (Fig. 7A and col. 7, lin. 16-21 disclose covering only the inner surface of the stent).
Regarding claim 4, Hossainy discloses wherein the covering material forms a tube that extends along the whole length of the base stent (Fig. 8 discloses a tubular stent having a covering which when covering the tubular inner surface would be a tubular covering; claim 5 discloses the entire inner surface of the stent has asperities which includes the stent’s length and col. 7, lin. 16-21 disclose the covering 401 is present on asperities).
Regarding claims 5 and 9-11, Hossainy discloses wherein the step of providing a base stent comprises roughening the surface to be penetrated by the covering material (Fig. 7A and col. 7, lin. 16-21 disclose the tubular inner surface of the stent comprises covering 401 where the covering extends into the rough surface or asperities); wherein the step of roughening comprises a step of micro grinding, press forming and/or sandblasting the surface to be roughened (col. 7, lin. 50-55 discloses sand blaster to form the asperities); wherein the step of roughening comprises applying a laser to the surface to be roughened (col. 3, lin. 19-25 discloses laser).
Regarding claim 6, Hossainy discloses the roughened surface comprises microcavities, wherein the microcavities are preferably blind holes (the asperities 314 are blind holes having a height of 0.1-10 microns; col. 9, lin. 1-6).
Regarding claim 12, Hossainy discloses wherein the rough surface comprises blind holes into which the covering material penetrates at least partially (Fig. 7A discloses the asperities 314 are blind holes).
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 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hossainy et al. (6979346) “Hossainy” in view of Venkatraman at al. (2018/0042742) “Venkatraman”.
Hossainy discloses the claimed invention of claim 8; except for wherein the rough surface comprises throughholes that penetrate through the base stent. However, Venkatraman teaches a similar stent 20 comprising holes 27 that penetrate through the base stent (Fig. 1 and par. 0020). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent in Hossainy to include throughholes that penetrate through the base stent, as taught and suggested by Venkatraman, for allowing deeper penetration of the covering material into the stent body providing a secured positive fit.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774