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 Preliminary Amendment
Claims 1-30 are pending in the application. Claims 31-63 are cancelled. Claims 18-12, 24, 25, 29, and 30 have been amended. Claims 1-30 are rejected.
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 22-30 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.
Claim 22 recites the limitation “the range of outer diameters including at least 4mm to 8mm” in lines 8-9 of the claim. This limitation is indefinite because it is unclear what other values are or are not included in the range of outer diameters. For the purposes of examination, this limitation is being interpreted as the implant exhibits a change in the expansion force of no more than 0.4N/mm when the outer diameter of the stent is 4mm to 8mm.
Claim 26 recites the limitation: “when the implant self-expands through the range of outer diameters” in lines 5-6 of the claim. There is insufficient antecedent basis for this limitation in the claim since claim 26 does not previously recite “a range of outer diameters”. For the purposes of examination, this limitation is being interpreted as “wherein the implant self-expands through a range of outer diameters”. Appropriate action is required.
Claim 26 recites the limitation “the range of outer diameters includes at least 4mm to 8mm” in lines 6-7 of the claim. This limitation is indefinite because it is unclear what other values are or are not included in the range of outer diameters. For the purposes of examination, this limitation is being interpreted as the implant exhibits a change in the expansion force of no more than 0.5N/mm when the outer diameter of the stent is 4mm to 8mm.
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) 1-5, 7, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Anukhin et al (US PG Pub 2011/0190872).
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Regarding claim 1, Anukhin teaches an intravascular implant (See, for example, Figs. 2, 9A, and 9B) comprising: a pair of inner rings comprising a distal inner ring and a proximal inner ring (See annotated Figs. 2 & 9), the distal and proximal inner rings each being formed by a plurality of struts (230) connected by apices to form a zig-zag pattern (See paragraphs [0120]-[0123]);
a plurality of inner bridges (237) that extend between every other opposing adjacent apices of the distal and proximal inner rings (See Figs. 2, 9A, and 9B – note the inner bridges 237 connect every other apex); at least some of plurality of inner bridges forming an eyelet (502). (See also paragraph [0164])
Although Anukhin shows multiple inner bridges (237) forming eyelets (502), it does not explicitly teach every inner bridge forms an eyelet. However, it would have been obvious to one of ordinary skill in the art at the time of invention to modify Anukhin to include an eyelet (502) in each of the plurality of inner bridges since to do so would be a mere duplication of a working part of the device. The mere duplication of essential working parts involves only routine skill in the art. Additionally, the court has held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See also MPEP §2144.04(VI)(B)
Anukhin further teaches a pair of outer rings comprising a distal outer ring and a proximal outer ring; the distal and proximal outer rings each being formed by a plurality of struts (230) connected by apices to form a zig-zag pattern (See Figs. 2, 9A, and 9B); and
a plurality of outer bridge members (234), the plurality of outer bridge members including outer bridge members that extend between opposing adjacent apices of the distal outer ring and distal inner ring and the plurality of outer bridge members including outer bridge members that extend between opposing adjacent apices of the proximal outer ring and proximal inner ring. (See Figs. 2, 9A, and 9B; paragraphs [0120]-[0123]).
Regarding claim 2, modified Anukhin teaches the implant as set forth in claim 1 above and further teaches the eyelet (502) on each of the plurality of inner bridges is circular (See Figs. 2, 9A, and 9B; paragraph [0164])
Regarding claim 3, modified Anukhin teaches the implant as set forth in claim 1 above and further teaches the plurality of outer bridges connects every other opposing adjacent apices of the distal outer ring and distal inner ring and wherein the plurality of outer bridges connects every other opposing adjacent apices of the proximal outer ring and proximal inner ring. (See Figs. 2, 9A, and 9B; paragraphs [0120]-[0123])
Regarding claim 4, modified Anukhin teaches the implant as set forth in claim 4 above and further teaches the plurality of inner bridges (237) are located longitudinally between the plurality of outer bridges (234). (See Fig. 2)
Regarding claim 5, modified Anukhin teaches the implant as set forth in claim 4 above and further teaches the plurality of outer bridges are linear (See Fig. 2 – note outer bridges 234 extend along a straight line and are thus considered “linear”)
Regarding claim 7, modified Anukhin teaches the implant as set forth in claim 1 above and further teaches the eyelet (502) includes a radiopaque marker (500) (See paragraphs [0163]-[1064] and [0166]).
Regarding claim 9, modified Anukhin teaches the implant as set forth in claim 1 above and further teaches the implant has an expanded diameter that is greater than 7 mm. (See paragraphs [0049]-[0053]; [0089], [0156]-[0159]; [0207])
Regarding claim 10, modified Anukhin teaches the implant as set forth in claim 1 above and further teaches the implant has an expanded diameter range of at least 4mm to 8mm. (See paragraphs [0049]-[0053]; [0089], [0156]-[0159]; [0207])
Claim(s) 6, 8, 11-15, and 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Anukhin et al (US PG Pub 2011/0190872) as applied to claim 1 above, and further in view of Giasolli et al (US PG Pub 2011/0301690).
Regarding claim 6, modified Anukhin teaches the implant of claim 1 as set forth above but does not explicitly teach the implant comprises Nitinol or is made of Nitinol. Anukhin does note that Nitinol is a commonly used material for making stents. (See paragraph [0012])
Giasolli teaches an analogous intravascular implant where the implant is made of Nitinol. (See paragraphs [0068] and [0070]). Giasolli teaches Nitinol is a preferred material for making stents due to its shape memory properties.
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the intravascular implant (Stent) as taught by Anukhin to be made of Nitinol since Nitinol is a widely used, advantageous material from which to make stents. Furthermore, it is deemed to be within the level of ordinary skill in the art to use a known material. “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” See §MPEP 2144.07.
Regarding claim 8, modified Anukhin teaches the implant of claim 1 as set forth above but does not explicitly teach the implant exhibits a change of radial expansion or compression force of less than 0.3 N/mm over at least a 4 mm outer diameter expansion range.
Giasolli teaches an analogous intravascular implant which advantageously has low radial expansion force and low radial compression force. Giasolli teaches the implant exhibits a change of radial expansion and compression of less than 1N/mm over at least a 4mm outer diameter expansion range (See Fig. 6A; paragraphs [0142]-[0151]). Giasolli teaches keeping the force as low as possible is advantageous since elevated radial forces can create adverse side effects such as irritation of the cells of the vessel wall which can lead to restenosis. (See paragraphs [0023], [0147], [0150]-[0151]). Giasolli teaches the change in radial expansion and compression force is less than 1N/mm and is preferably “as low as possible” but does not explicitly state the change in force is less than 0.3N/mm. It would have been obvious to one of ordinary skill in the art at the time of filing to have the difference between the radial force of the compression force curve and the expansion force curve be no more than about 0.30 Newtons per length of the implant along the implant’s longitudinal axis (N/mm) through the range of outer diameters since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the intravascular implant (stent) as taught by modified Anukhin with the teachings of Giasolli so as to create an implant that exhibits a change of radial expansion or compression force of less than 0.3 N/mm over at least a 4 mm outer diameter expansion range since it is known to be advantageous to minimize the outward radial force of the implant as well as the change in forces as the implant expands in the vessel so as to avoid damaging or irritating the cells of the vessel lining which is known to lead to restenosis and adverse patient outcomes.
Regarding claim 11, modified Anukhin teaches the implant of claim 10 as set forth above but does not explicitly teach within the expanded diameter range the implant exhibits a change in both the radial expansion and compression force of less than 0.35 Newton per length of the implant along the implant’s longitudinal axis (N/mm).
Giasolli teaches an analogous intravascular implant which advantageously has low radial expansion force and low radial compression force. Giasolli teaches the implant exhibits a change of radial expansion and compression of less than 1N/mm over the outer diameter expansion range (See Fig. 6A; paragraphs [0142]-[0151]). Giasolli teaches keeping the force as low as possible is advantageous since elevated radial forces can create adverse side effects such as irritation of the cells of the vessel wall which can lead to restenosis. (See paragraphs [0023], [0147], [0150]-[0151]). Giasolli teaches the change in radial expansion and compression force is less than 1N/mm and is preferably “as low as possible” but does not explicitly state the change in force for both the radial expansion and compression is less than 0.35N per length of the implant along the implant’s longitudinal axis (N/mm). It would have been obvious to one of ordinary skill in the art at the time of filing to have the difference between the radial force of the compression force curve and the expansion force curve be no more than about 0.35 Newtons per length of the implant along the implant’s longitudinal axis (N/mm) through the range of outer diameters since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the intravascular implant (stent) as taught by modified Anukhin with the teachings of Giasolli so as to create an implant that exhibits a change of radial expansion or compression force of less than 0.35 N/mm over the outer diameter expansion range since it is known to be advantageous to minimize the outward radial force of the implant as well as the change in forces as the implant expands in the vessel so as to avoid damaging or irritating the cells of the vessel lining which is known to lead to restenosis and adverse patient outcomes.
Regarding claim 12, modified Anukhin teaches the implant of claim 10 as set forth above but does not explicitly teach within the expanded diameter range the implant exhibits a change in both the radial expansion and compression force is between 0.1 and 0.35 Newton per length of the implant along the implant’s longitudinal axis (N/mm).
Giasolli teaches an analogous intravascular implant which advantageously has low radial expansion force and low radial compression force. Giasolli teaches the implant exhibits a change of radial expansion and compression of less than 1N/mm over the outer diameter expansion range (See Fig. 6A; paragraphs [0142]-[0151]). Giasolli teaches keeping the force as low as possible is advantageous since elevated radial forces can create adverse side effects such as irritation of the cells of the vessel wall which can lead to restenosis. (See paragraphs [0023], [0147], [0150]-[0151]). Giasolli teaches the change in radial expansion and compression force is less than 1N/mm and is preferably “as low as possible” but does not explicitly state the change in force for both the radial expansion and compression between 0.1 and 0.35 Newton per length of the implant along the implant’s longitudinal axis (N/mm).
As disclosed, the change in both radial expansion and compression forces is a result effective variable which assists with reducing damage to the patient’s blood vessel. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Giasolli to have the range of change in both the radial expansion and compression forces between 0.1 and 0.35 Newton per length of the implant along the implant’s longitudinal axis (N/mm), 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 range of change in both the radial expansion and compression force to be between 0.35 and 0.1 Newton per length of the implant along the implant’s longitudinal axis (N/mm) 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
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the intravascular implant (stent) as taught by modified Anukhin with the teachings of Giasolli so as to create an implant that exhibits a change of radial expansion and compression force of between 0.1 and 0.35 Newton per length of the implant along the implant’s longitudinal axis (N/mm) since it is known to be advantageous to minimize the outward radial force of the implant as well as the minimize change in forces as the implant expands in the vessel so as to avoid damaging or irritating the cells of the vessel lining which is known to lead to restenosis and adverse patient outcomes.
Regarding claim 13, modified Anukhin teaches the implant of claim 10 as set forth above but does not explicitly teach within the expanded diameter range the implant exhibits a change in both the radial expansion and compression force of less than 3.5 Newtons.
Giasolli teaches an analogous intravascular implant which advantageously has low radial expansion force and low radial compression force. Giasolli teaches the implant exhibits a change of radial expansion and compression of less than 1N/mm over the outer diameter expansion range (See Fig. 6A; paragraphs [0142]-[0151]). Giasolli teaches keeping the force as low as possible is advantageous since elevated radial forces can create adverse side effects such as irritation of the cells of the vessel wall which can lead to restenosis a known undesirable complication. (See paragraphs [0023], [0147], [0150]-[0151]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the intravascular implant (stent) as taught by modified Anukhin with the teachings of Giasolli so as to create an implant that exhibits a change in both the radial expansion and compression force of less than 3.5 Newtons since it is known to be advantageous to minimize the outward radial force of the implant as well as the minimize change in forces as the implant expands in the vessel so as to avoid damaging or irritating the cells of the vessel lining which is known to lead to restenosis and adverse patient outcomes.
Regarding claim 14, modified Anukhin teaches the implant of claim 10 as set forth above but does not explicitly teach within the expanded diameter range the implant exhibits a change in both the radial expansion and compression force of between 3.5 and 1 Newton.
Giasolli teaches an analogous intravascular implant which advantageously has low radial expansion force and low radial compression force. Giasolli teaches the implant exhibits a change of radial expansion and compression of no more than about 2N/mm over the outer diameter expansion range (See paragraph [0149]; Fig. 6A; generally paragraphs [0142]-[0151]). Giasolli teaches keeping the force as low as possible is advantageous since elevated radial forces can create adverse side effects such as irritation of the cells of the vessel wall which can lead to restenosis a known undesirable complication. (See paragraphs [0023], [0147], [0150]-[0151]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the intravascular implant (stent) as taught by modified Anukhin with the teachings of Giasolli so as to create an implant that exhibits a change in both the radial expansion and compression force of between 3.5 and 1 Newton since it is known to be advantageous to minimize the outward radial force of the implant as well as the minimize change in forces as the implant expands in the vessel so as to avoid damaging or irritating the cells of the vessel lining which is known to lead to restenosis and adverse patient outcomes.
Regarding claim 15, modified Anukhin teaches the implant of claim 1 as set forth above but does not explicitly teach the implant is self-expandable. Anukhin notes that both self-expanding and balloon expandable stents are known in the art. (See paragraph [0012]).
Giasolli teaches an analogous intravascular implant which may be either self-expanding or balloon expandable (See paragraph [0065]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the implant of Anukhin to be self-expanding as taught by Giasolli since both self-expanding and balloon expandable stents are widely known and used in the art and are obvious variants of one another. Additionally, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183)
Regarding claim 18, modified Anukhin teaches the implant of claim 1 as set forth above but does not explicitly teach the implant exhibits an expansion force during an expanded diameter range of at least 4 mm to 8 mm of between 0.7 and 0.18 Newton per length of the implant along the implant’s longitudinal axis (N/mm).
Giasolli teaches an analogous intravascular implant which advantageously has low radial expansion force. Giasolli teaches the implant exhibits a radial expansion force of “no more than 5N at any point throughout the range.” And further states “the maximum radial expansion force throughout the expansion range is no more than about 4N and preferably is no more than about 3 N. (See paragraph [0149]; Fig. 6A; generally paragraphs [0142]-[0151]). Giasolli teaches the implant is 6mm in length (See paragraph [0146]) which yields a range of expansion force of 0.5-0.83N/mm. Giasolli teaches keeping the force as low as possible is advantageous since elevated radial forces can create adverse side effects such as irritation of the cells of the vessel wall which can lead to restenosis a known undesirable complication. (See paragraphs [0023], [0147], [0150]-[0151]).
Giasolli does not explicitly teach the range of outer diameters includes at least 4 mm to 8 mm. Giasolli does teach the range of outer diameters is between 2mm and 7.5mm (See Fig. 6A; paragraph [0145]). As disclosed, the range of outer diameters of the stent is a result effective variable which assists with holding open a blood vessel when implanted in the body. It is further noted, that there is a finite range of diameters for implantable stents with the upper limit of the diameter being dictated by the diameter of the blood vessel or body lumen into which the stent is implanted. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Giasolli to have the range of outer diameters be between 4mm to 8mm, 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 range of outer implant diameters to be include at least 4mm to 8mm 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
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the intravascular implant (stent) as taught by modified Anukhin with the teachings of Giasolli so as to create an implant that exhibits an expansion force during an expanded diameter range of at least 4 mm to 8 mm of between 0.7 and 0.18 Newton per length of the implant along the implant’s longitudinal axis (N/mm) since it is known to be advantageous to minimize the outward radial force of the implant as well as the minimize change in forces as the implant expands in the vessel so as to avoid damaging or irritating the cells of the vessel lining which is known to lead to restenosis and adverse patient outcomes.
Regarding claim 19, modified Anukhin teaches the implant of claim 1 as set forth above but does not explicitly teach the implant exhibits an expansion force during an expanded diameter range of at least 4 mm to 8 mm of between 7 and 2 Newtons.
Giasolli teaches an analogous intravascular implant which advantageously has low radial expansion force. Giasolli teaches the implant exhibits a radial expansion force of “no more than 5N at any point throughout the range.” And further states “the maximum radial expansion force throughout the expansion range is no more than about 4N and preferably is no more than about 3 N) (See paragraph [0149]; Fig. 6A; generally paragraphs [0142]-[0151]). Giasolli teaches keeping the force as low as possible is advantageous since elevated radial forces can create adverse side effects such as irritation of the cells of the vessel wall which can lead to restenosis a known undesirable complication. (See paragraphs [0023], [0147], [0150]-[0151]).
Giasolli does not explicitly teach the range of outer diameters includes at least 4 mm to 8 mm. Giasolli does teach the range of outer diameters is between 2mm and 7.5mm (See Fig. 6A; paragraph [0145]). As disclosed, the range of outer diameters of the stent is a result effective variable which assists with holding open a blood vessel when implanted in the body. It is further noted, that there is a finite range of diameters for implantable stents with the upper limit of the diameter being dictated by the diameter of the blood vessel or body lumen into which the stent is implanted. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Giasolli to have the range of outer diameters be between 4mm to 8mm, 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 range of outer implant diameters to be include at least 4mm to 8mm 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
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the intravascular implant (stent) as taught by modified Anukhin with the teachings of Giasolli so as to create an implant that exhibits an expansion force during an expanded diameter range of at least 4 mm to 8 mm of between 7 and 2 Newtons since it is known to be advantageous to minimize the outward radial force of the implant as well as the minimize change in forces as the implant expands in the vessel so as to avoid damaging or irritating the cells of the vessel lining which is known to lead to restenosis and adverse patient outcomes.
Regarding claim 20, modified Anukhin teaches the implant of claim 1 as set forth above but does not explicitly teach the implant exhibits a compression force during an expanded diameter range of at least 4 mm to 8 mm of between 0.4 and 1.25 Newtons per length of the implant along the implant’s longitudinal axis.
Giasolli teaches an analogous intravascular implant which advantageously has low radial expansion force. Giasolli teaches the implant exhibits a radial expansion force of “no more than 5N at any point throughout the range.” And further states “the maximum radial expansion force throughout the expansion range is no more than about 4N and preferably is no more than about 3 N. Giasolli also states “Typically the difference between the radial force of compression and the radial expansion force at any given diameter throughout the expansion range is no more than about 4 N, generally no more than about 3 N, preferably no more than about 2 N and in one embodiment is no more than about 1 N.” (See paragraph [0149]; Fig. 6A; generally paragraphs [0142]-[0151]). These combined teaching of Giasolli yield a range of compression force between 4 and 9 Newtons (See footnote 2 below). Giasolli teaches the implant is 6mm long which results in a range of 0.667 to 1.5 Newtons per length of the implant1. Giasolli teaches keeping the force as low as possible is advantageous since elevated radial forces can create adverse side effects such as irritation of the cells of the vessel wall which can lead to restenosis a known undesirable complication. (See paragraphs [0023], [0147], [0150]-[0151]).
Giasolli does not explicitly teach the range of outer diameters includes at least 4 mm to 8 mm. Giasolli does teach the range of outer diameters is between 2mm and 7.5mm (See Fig. 6A; paragraph [0145]). As disclosed, the range of outer diameters of the stent is a result effective variable which assists with holding open a blood vessel when implanted in the body. It is further noted, that there is a finite range of diameters for implantable stents with the upper limit of the diameter being dictated by the diameter of the blood vessel or body lumen into which the stent is implanted. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Giasolli to have the range of outer diameters be between 4mm to 8mm, 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 range of outer implant diameters to be include at least 4mm to 8mm 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
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the intravascular implant (stent) as taught by modified Anukhin with the teachings of Giasolli so as to create an implant that exhibits a compression force during an expanded diameter range of at least 4 mm to 8 mm of between 0.4 and 1.25 Newtons per length of the implant along the implant’s longitudinal axis since it is known to be advantageous to minimize the outward radial force of the implant as well as the minimize change in forces as the implant expands in the vessel so as to avoid damaging or irritating the cells of the vessel lining which is known to lead to restenosis and adverse patient outcomes.
Regarding claim 21, modified Anukhin teaches the implant of claim 1 as set forth above but does not explicitly teach the implant exhibits a compression force during an expanded diameter range of at least 4 mm to 8 mm of between 4 and 13 Newtons.
Giasolli teaches an analogous intravascular implant which advantageously has low radial expansion force. Giasolli teaches the implant exhibits a radial expansion force of “no more than 5N at any point throughout the range.” And further states “the maximum radial expansion force throughout the expansion range is no more than about 4N and preferably is no more than about 3 N. Giasolli also states “Typically the difference between the radial force of compression and the radial expansion force at any given diameter throughout the expansion range is no more than about 4 N, generally no more than about 3 N, preferably no more than about 2 N and in one embodiment is no more than about 1 N.”2 (See paragraph [0149]; Fig. 6A; generally paragraphs [0142]-[0151]). These combined teaching of Giasolli yield a range of compression force between 4 and 9 Newtons. Giasolli teaches keeping the force as low as possible is advantageous since elevated radial forces can create adverse side effects such as irritation of the cells of the vessel wall which can lead to restenosis a known undesirable complication. (See paragraphs [0023], [0147], [0150]-[0151]).
Giasolli does not explicitly teach the range of outer diameters includes at least 4 mm to 8 mm. Giasolli does teach the range of outer diameters is between 2mm and 7.5mm (See Fig. 6A; paragraph [0145]). As disclosed, the range of outer diameters of the stent is a result effective variable which assists with holding open a blood vessel when implanted in the body. It is further noted, that there is a finite range of diameters for implantable stents with the upper limit of the diameter being dictated by the diameter of the blood vessel or body lumen into which the stent is implanted. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Giasolli to have the range of outer diameters be between 4mm to 8mm, 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 range of outer implant diameters to be include at least 4mm to 8mm 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
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the intravascular implant (stent) as taught by modified Anukhin with the teachings of Giasolli so as to create an implant that exhibits an compression force during an expanded diameter range of at least 4 mm to 8 mm of between 4 and 13 Newtons since it is known to be advantageous to minimize the outward radial force of the implant as well as the minimize change in forces as the implant expands in the vessel so as to avoid damaging or irritating the cells of the vessel lining which is known to lead to restenosis and adverse patient outcomes.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Anukhin et al (US PG Pub 2011/0190872) as applied to claim 1 above, and further in view of Mao et al (US PG Pub 2009/0076584).
Regarding claims 16 and 17, modified Anukhin teaches the implant of claim 1 above and further teaches the pair of inner rings, the plurality of inner bridges, the pair of outer rings and the plurality of outer bridge members form cells (See Figs. 2 and 9A above). Modified Anukhin is silent as to the total number of columns in the implant.
Mao teaches an analogous stent for implantation in the vasculature where each stent has exactly three columns3 (See Figs. 6A-6H and 7; paragraph [0075]). Mao teaches a modular implant made up of stent segments that are implanted either separately or in combination. Mao teaches the smaller stent segments which have only 3 columns of cells allow for increased flexibility during delivery and customization of length for particular patient need. (See paragraphs [0006], [0007], [0023]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the implant as taught by modified Anukhin to have only three columns of cells as taught by Mao since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Additionally, stents of varying lengths are widely known throughout the art and one of ordinary skill would be sufficiently able to select the appropriate length for the desired characteristics of the particular patient and treatment site.
Claim(s) 22-24 and 26-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giasolli et al (US PG Pub 2011/0301690).
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Regarding claim 22, Giasolli teaches an intravascular implant (10’) comprising: a plurality of struts (27/28 forming ring 12) connected by apices (18) (See Figs. 5B & 5E) in a zig-zag pattern (sinusoidal) (See Figs. 5B & 5E) to form a tubular body (See Fig. 5A) having a distal end and a proximal end and a lumen extending there through (See Figs. 5A & 5B);
wherein the tubular body has a compression force curve (line A1 Seen in Fig. 6A; see also paragraphs [0142]-[0151]) being a measure of an amount of radial compression force required to compress the tubular body along a range of outer diameters (See paragraph [0145]), and has an expansion force curve (line B1 Seen Fig. 6A) being a measure of an amount of radial expansion force exerted by the tubular body when the implant self-expands through the range of outer diameters (See paragraphs [0145], [0147]-[0149).
Giasolli does not explicitly teach the range of outer diameters includes at least 4 mm to 8 mm. Giasolli does teach the range of outer diameters is between 2mm and 7.5mm (See Fig. 6A; paragraph [0145]). As disclosed, the range of outer diameters of the stent is a result effective variable which assists with holding open a blood vessel when implanted in the body. It is further noted, that there is a finite range of diameters for implantable stents with the upper limit of the diameter being dictated by the diameter of the blood vessel or body lumen into which the stent is implanted. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Giasolli to have the range of outer diameters be between 4mm to 8mm, 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 range of outer implant diameters to be include at least 4mm to 8mm 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
Giasolli further teaches within the range of outer diameters the compression force is greater than the expansion force (See Fig. 6A) and a difference between the radial force of the compression force curve and the expansion force curve is no more than about 0.40 Newtons per length of the implant along the implant’s longitudinal axis (N/mm) through the range of outer diameters. (See Fig. 6A, note that both the compression force curve A1 and the expansion force curve B1 values are between 0 and 1 Newton and appear to be less than 0.5N. Thus the difference between the compression force curve A1 and the expansion force curve B1 must be less than 0.4N/mm based on the graph as depicted.) Additionally, Giasolli explicitly states “the difference between the compression force and expansion force at each point along the corresponding compression/expansion range differs…preferably by no more than about 1N.” (See last line in paragraph [0149]). Thus, Giasolli discloses the optimum range of values is between 0N and 1N.
Alternatively, it would have been obvious to one of ordinary skill in the art at the time of filing to have the difference between the radial force of the compression force curve and the expansion force curve be no more than about 0.40 Newtons per length of the implant along the implant’s longitudinal axis (N/mm) through the range of outer diameters since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 23, Giasolli as modified above teaches the device of claim 22, but does not explicitly teach the difference between the radial force of the compression force curve and the expansion force curve is greater than about 0.10 Newtons per length of the implant along the implant’s longitudinal axis (N/mm) through the range of outer diameters.
Giasolli states “the difference between the compression force and expansion force at each point along the corresponding compression/expansion range differs…preferably by no more than about 1N.” (See last line in paragraph [0149]). Thus, Giasolli discloses the optimum range of values is between 0N and 1N.
It would have been obvious to one of ordinary skill in the art at the time of filing to have the difference between the radial force of the compression force curve and the expansion force curve be no more than about 0.10 Newtons per length of the implant along the implant’s longitudinal axis (N/mm) through the range of outer diameters since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 24, Giasolli as modified above teaches the device of claim 22 and further teaches the plurality of struts form cells (16) and wherein there are between 1 and 5 columns of cells. (See Figs. 5A, 5B, and 7A-7D; note there are 2 columns of cells)
Regarding claim 26, Giasolli teaches an intravascular implant (10’) comprising: a plurality of struts (27/28 forming ring 12) connected by apices (18) (See Figs. 5B & 5E) in a zig-zag pattern (sinusoidal) (See Figs. 5B & 5E) to form a tubular body (See Fig. 5A) having a distal end and a proximal end and a lumen extending there through (See Figs. 5A & 5B);
wherein the tubular body has a compression force curve (line A1 Seen in Fig. 6A; see also paragraphs [0142]-[0151]) being a measure of an amount of radial compression force required to compress the tubular body along a range of outer diameters (See paragraph [0145]), and has an expansion force curve (line B1 Seen Fig. 6A) being a measure of an amount of radial expansion force exerted by the tubular body when the implant self-expands through the range of outer diameters (See paragraphs [0145], [0147]-[0149).
Giasolli does not explicitly teach the range of outer diameters includes at least 4 mm to 8 mm. Giasolli does teach the range of outer diameters is between 2mm and 7.5mm (See Fig. 6A; paragraph [0145]). As disclosed, the range of outer diameters of the stent is a result effective variable which assists with holding open a blood vessel when implanted in the body. It is further noted, that there is a finite range of diameters for implantable stents with the upper limit of the diameter being dictated by the diameter of the blood vessel or body lumen into which the stent is implanted. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Giasolli to have the range of outer diameters be between 4mm to 8mm, 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 range of outer implant diameters to be include at least 4mm to 8mm 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
Giasolli further teaches within the range of outer diameters the compression force is greater than the expansion force (See Fig. 6A) and a difference between the radial force of the compression force curve and the expansion force curve is no more than about 0.50 Newtons per length of the implant along the implant’s longitudinal axis (N/mm) through the range of outer diameters. (See Fig. 6A, note that both the compression force curve A1 and the expansion force curve B1 values are between 0 and 1 Newton and appear to be less than 0.5N. Thus the difference between the compression force curve A1 and the expansion force curve B1 must be less than 0.4N/mm based on the graph as depicted.) Additionally, Giasolli explicitly states “the difference between the compression force and expansion force at each point along the corresponding compression/expansion range differs…preferably by no more than about 1N.” (See last line in paragraph [0149]). Thus, Giasolli discloses the optimum range of values is between 0N and 1N.
Alternatively, it would have been obvious to one of ordinary skill in the art at the time of filing to have the difference between the radial force of the compression force curve and the expansion force curve be no more than about 0.50 Newtons per length of the implant along the implant’s longitudinal axis (N/mm) through the range of outer diameters since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 27, Giasolli as modified above teaches the device of claim 26, but does not explicitly teach the difference between the radial force of the compression force curve and the expansion force curve is greater than about 0.40 Newtons per length of the implant along the implant’s longitudinal axis (N/mm) through the range of outer diameters.
Giasolli states “the difference between the compression force and expansion force at each point along the corresponding compression/expansion range differs…preferably by no more than about 1N.” (See last line in paragraph [0149]). Thus, Giasolli discloses the optimum range of values is between 0N and 1N.
It would have been obvious to one of ordinary skill in the art at the time of filing to have the difference between the radial force of the compression force curve and the expansion force curve be no more than about 0.40 Newtons per length of the implant along the implant’s longitudinal axis (N/mm) through the range of outer diameters since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 28, Giasolli as modified above teaches the device of claim 26, but does not explicitly teach the difference between the radial force of the compression force curve and the expansion force curve is greater than about 0.10 Newtons per length of the implant along the implant’s longitudinal axis (N/mm) through the range of outer diameters.
Giasolli states “the difference between the compression force and expansion force at each point along the corresponding compression/expansion range differs…preferably by no more than about 1N.” (See last line in paragraph [0149]). Thus, Giasolli discloses the optimum range of values is between 0N and 1N.
It would have been obvious to one of ordinary skill in the art at the time of filing to have the difference between the radial force of the compression force curve and the expansion force curve be no more than about 0.10 Newtons per length of the implant along the implant’s longitudinal axis (N/mm) through the range of outer diameters since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 29, Giasolli as modified above teaches the device of claim 26 and further teaches the plurality of struts form cells (16) and wherein there are between 1 and 5 columns of cells. (See Figs. 5A, 5B, and 7A-7D; note there are 2 columns of cells)
Claim(s) 25 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giasolli et al (US PG Pub 2011/0301690) as applied to claims 22 and 26 above, and further in view of Mao et al (US PG Pub 2009/0076584).
Regarding claim 25, Giasolli as modified above teaches the device of claim 22 and further teaches the plurality of struts form cells (16). Giasolli does not explicitly teach there are only three columns of cells.
Mao teaches an analogous stent for implantation in the vasculature where each stent has exactly three columns (See Figs. 6A-6H and 7; paragraph [0075]). Mao teaches a modular implant made up of stent segments that are implanted either separately or in combination. Mao teaches the smaller stent segments allow for increased flexibility during delivery and customization of length for particular patient need. (See paragraphs [0006], [0007], [0023]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the implant as taught by Giasolli to have only thre