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 .
Claims Status
Claims 1-10 are pending in the application. Claims 1-10 are rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et. al. (US Pat. No. 10,449,068).
Regarding claim 1, Park teaches a stent (See Col. 5, lines 47-55) formed by weaving a wire (10) into a tubular shape (See Col. 5, line 65 through Col. 6 line 10), the stent comprising:
intersecting portions (B/X) at which the wire intersects (overlaps); and
interlocking portions (A) at which the wire interlocks (hooks around the wire), (See Col. 8, lines 16-27) wherein
at least two stretch assisting columns (a3 and a10) are continuously disposed1 in a circumferential direction of the stent, each of the at least two stretch assisting columns including a larger number of the intersecting portions than the interlocking portions in an axial direction of the stent (See Fig. 16), and
at least one contraction assisting column (a1, a2, a4, a5, a6, a7, a8, a9, a11, a12, a13, a14, and a15) including a larger number of the interlocking portions than the intersecting portions in the axial direction is disposed. (See Fig. 16).
Regarding claim 2, Park teaches the stent of claim 1 as set forth above and further teaches when the stent is equally divided2 in the circumferential direction by a plane including an axis of the stent and a first equally-divided region includes the at least two stretch assisting columns continuously disposed, a second equally-divided region includes a majority of the interlocking portions (See Fig. 16).
Regarding claim 9, Park teaches the stent of claim 1 as set forth above and further teaches the wire includes a first wire (10) and a second wire (20), and a first stretch assisting region and a second stretch assisting region overlap with each other (See Fig. 16; Col.8, lines 34-50; Col. 9, lines 13-22; Col. 11, lines 32-39) , the first stretch assisting region (a3 and a10 from b1 to b17) including the at least two stretch assisting columns continuously disposed in the first wire, the second stretch assisting region (a3 and a10 from b18 to b21) including the at least two stretch assisting columns continuously disposed in the second wire. Note the first wire (10) and second wire (20) are connected together to be provided as a single stent (See Col. 11, lines 31-40)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Park et. al. (US Pat. No. 10,449,068).
Regarding claim 3, Park teaches the stent of claim 1 as set forth above but does not expressly teach the stent has at least three stretch assisting columns continuously disposed in the circumferential direction.
As disclosed, the number of stretch assisting columns is a result effective variable which assists with stretching and deployment of the stent. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Park to have three or whatever number of stretch assisting columns was desired or expedient, as it only involves adjusting the dimension of a component already disclosed to be adjustable. 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 Park to have at least three stretch assisting columns continuously disposed in the circumferential direction as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05.
Regarding claim 4, Park teaches the stent according to claim 1, as set forth above and further teaches the number of positions in the circumferential direction at which the wire is capable of forming the intersecting portions or the interlocking portions is 6 or greater (See Fig. 16, note there are 15 columns (a1-a15) which create 15 positions in the circumferential direction capable of being interlocking or intersecting portions which is greater than 6).
Park does not explicitly teach a plurality of stretch assisting regions are disposed separately from each other along the circumferential direction, each of the plurality of stretch assisting regions including the at least two stretch assisting columns continuously disposed.
As disclosed, the number of stretch assisting regions is a result effective variable which assists with stretching and deployment of the stent particularly in a curved vessel. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Park to have whatever number of stretch assisting regions each including two stretch assisting columns was desired or expedient, as it only involves adjusting the dimension of a component already disclosed to be adjustable. 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 Park to have a plurality stretch assisting regions each including the at least two stretch assisting columns continuously disposed as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05.
Regarding claim 5, Park teaches the stent of claim 1 as set forth above and further teaches X is the number of positions in the circumferential direction at which the wire is capable of forming the intersecting portions or the interlocking portions (crossing points in each of columns a1-a15), Y is the number of positions in the axial direction at which the wire is capable of forming the intersecting portions or the interlocking portions (crossing points in each of the rows b1-b21), and Z is the number of times the wire is woven back and forth in the axial direction (See Col. 8, lines 1-15 and Col. 9, line 13 through Col. 10 line 8).
Park does not expressly teach the number of the interlocking portions is (X - Z)(Y - 1), and the number of the intersecting portions is XY + (Y - 1)Z.
As disclosed, the number of intersecting and interlocking portions is a result effective variable which assists with stretching and contracting of the stent to allow the stent to curve when deployed. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Park to have whatever number or ratio of interlocking and intersecting was desired or expedient, as it only involves adjusting the dimension of a component already disclosed to be adjustable. 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 Park to have the number of intersecting points and interlocking points follow the claimed formula as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05.
Regarding claims 6 and 7, Park teaches the stent required by claim 1 as set forth above and further teaches a contraction assisting region (rows a11-a15 and a1-a2) including a plurality of the contraction assisting columns (rows a11-a15 and a1-a2) is formed in a region in the circumferential direction excluding a stretch assisting region (rows a3-a10) including the at least two stretch assisting columns continuously disposed.
Park does not expressly teach 70% or more of the interlocking portions are provided in the contraction assisting region. With specific regard to claim 7, Park does not expressly teach 90% or more of the interlocking portions are provided in the contraction assisting region.
As disclosed, the percentage of interlocking portions provided in the contraction assisting region is a result effective variable which assists with contracting (decreased flexibility) of a portion of the stent to allow the stent to curve when deployed. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Park to have whatever number or percentage of interlocking portions provided in the contraction assisting region, as it only involves adjusting the dimension of a component already disclosed to be adjustable. 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 Park to have the contracting assisting region contain 70% or more or 90% or more of the interlocking portions as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05.
Regarding claim 8, modified Park teaches the stent as required by claim 7 as set forth above but does not explicitly teach all the interlocking portions are provided in the contraction assisting region.
As disclosed, the number or percentage of interlocking portions provided in the contraction assisting region is a result effective variable which assists with contracting (decreased flexibility) of a portion of the stent to allow the stent to curve when deployed. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Park to have whatever number or percentage of interlocking portions provided in the contraction assisting region, as it only involves adjusting the dimension of a component already disclosed to be adjustable. 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 Park to have the contracting assisting region contain all of the interlocking portions as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Park et. al. (US Pat. No. 10,449,068) in view of Konya et. al. (US Pat. No. 6,792,979).
Regarding claim 10, Park teaches a stent (See Col. 5, lines 47-55) formed by weaving a wire (10) into a tubular shape (See Col. 5, line 65 through Col. 6 line 10), the stent comprising:
intersecting portions (B/X) at which the wire intersects (overlaps); and
interlocking portions (A) at which the wire interlocks (hooks around the wire), (See Col. 8, lines 16-27) wherein
at least two stretch assisting columns (a3 and a10) are continuously disposed3 in a circumferential direction of the stent, each of the at least two stretch assisting columns including a larger number of the intersecting portions than the interlocking portions in an axial direction of the stent (See Fig. 16), and
at least one contraction assisting column (a1, a2, a4, a5, a6, a7, a8, a9, a11, a12, a13, a14, and a15) including a larger number of the interlocking portions than the intersecting portions in the axial direction is disposed. (See Fig. 16).
Park does not expressly teach the device is a stent graft where with a graft covering the stent.
Konya teaches an analogous intravascular implant which may be a bare wire stent or the wire stent may be a partially or completely covered with graft material to form a stent graft. (See Col. 5, lines 38-50 and Col. 29, line 42 through Col. 30, line 8). Konya teaches the graft material may have different porosities depending on the desired location. Konya teaches the graft material can aid in facilitating endothelial ingrowth or prevent tumor ingrowth into the stent graft lumen. It is noted that graft coverings on stents are widely known and used in the medical arts.
It would have been obvious to one of ordinary skill in the art before the effective filing date to add a graft covering as taught by Konya to the bare wire stent as taught by Park since adding a graft covering to a stent is merely applying a known technique to a known device to yield predictable results. See MPEP §2143(I)(D). Additionally both bare wire and covered stent grafts are widely known and used in the art and one of ordinary skill would be sufficiently able to select an appropriate graft covering based on the desired characteristics of the stent for the desired deployment location.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm .
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/R.S.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
1 note columns a1-a15 are all continuously disposed in a circumferential direction of the stent. The claims as presently presented do not require the two stretch assisting columns be directly adjacent one another. It is the examiner’s position that each of the columns a1-a15 are “continuously disposed in a circumferential direction” with each of the other columns since all the columns are connected and thus continuous in the circumferential direction.
2 Note that since the stent is tubular, drawing a line between any two columns will result in two equally divided regions. If the line is drawn between a2 and a3 or between a10 and a11, then both stretch assisting columns (a3 and a10) will be in the same equally divided region. This will also result in the other portion having a majority of the interlocking (hooked) portions.
3 note columns a1-a15 are all continuously disposed in a circumferential direction of the stent. The claims as presently presented do not require the two stretch assisting columns be directly adjacent one another. It is the examiner’s position that each of the columns a1-a15 are “continuously disposed in a circumferential direction” with each of the other columns since all the columns are connected and thus continuous in the circumferential direction.
Prosecution Insights