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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 21, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Claims 14-33 are pending in the application. Claims 1-13 have been cancelled. Claims 14-33 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) 14, 16, 20, 22, and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by applicant cited McCullagh et al (US PG Pub 2004/0098099).
Regarding claim 14, McCullagh teaches a stent (100) comprising: a tubular braided mesh of wires (See Fig. 1B), each wire respectively helically wound about a longitudinal axis of the braided mesh (See Fig. 1B) and arranged to cross over and under each other wire (See Fig. 1B; paragraph [0038]), wherein in a non-operational state1, the braided mesh has a proximal cylindrical section (120) and a distal cylindrical section (110) connected by a transitional section (130), and wherein the proximal cylindrical section has a cross sectional diameter (See Fig. 1B; paragraph [0007] and [0022]) and a porosity (See paragraph [0054]) that are different than that of the distal cylindrical section.
Regarding claim 16, McCullagh teaches the stent required by claim 14 as set forth above and further teaches the proximal cylindrical section (120) has a larger cross sectional diameter than that of the distal cylindrical section (110) (See Fig. 1B; paragraph [0022] and [0028]).
Regarding claim 20, McCullagh teaches the stent required by claim 14 as set forth above and further teaches the distal cylindrical section comprises a distal longitudinal end of the braided mesh wherein the wires form end loops (140). (See Fig. 1B; paragraphs [0037], [0048], and [0049]).
Regarding claim 22, McCullagh teaches the stent required by claim 14 as set forth above and further teaches the transitional section (130) is conical in shape. (See Fig. 1B; paragraphs [0023] and [0045])
Regarding claim 24, McCullagh teaches the stent required by claim 14 as set forth above and further teaches the braided mesh has between 12 and 36 wires. (See paragraph [0037] which states the braid has 24 wires)
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claims 15, 18, 19, 26-30, 32, 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited McCullagh et al (US PG Pub 2004/0098099) in view of applicant cited Yodfat (US PG Pub 2004/0024416).
Regarding claim 15, McCullagh teaches the stent required by claim 14 as set forth above but does not expressly teach the proximal cylindrical section has a higher porosity than the distal cylindrical section.
Yodfat teaches an analogous stent which has separate zones with different porosities for each (See Figs. 8-9). Yodfat teaches the proximal section (l2) has a higher porosity than the distal section (l1). (See Fig. 9; paragraphs [0090], [0091]). Yodfat teaches varying the porosity allows for a more effective stent. Yodfat also teaches porosity is a function of the braiding angle and total number of wires. (See paragraphs [0091]-[0097]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the stent as taught by McCullagh such that the proximal cylindrical section has a higher porosity than the distal cylindrical section or whatever other porosity arrangement was desired or expedient since it is known in the art to vary the porosity of a stent depending upon the parameters of the desired treatment location. Additionally, as stated in MPEP §2144.05(II)(A): “It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)
Regarding claim 18, McCullagh teaches the stent required by claim 14 as set forth above but does not expressly teach the distal cylindrical section has a braiding angle that is different than that of the proximal cylindrical section.
Yodfat teaches an analogous stent which has separate zones with different braiding angles. Yodfat also teaches porosity is a function of the braiding angle and total number of wires. (See Figs. 8-9; paragraphs [0091]-[0097]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the stent as taught by McCullagh such that the distal cylindrical section has a braiding angle that is different than that of the proximal cylindrical section as taught by Yodfat since it is known in the art to modify the braiding angle of the wires in order to achieved the desired porosity profile for the stent depending upon the particular deployment criteria for a particular patient. Additionally, as stated in MPEP §2144.05(II)(A): “It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)
Regarding claim 19, modified McCullagh teaches the stent required by claim 18 as set forth above but does not expressly teach the braiding angle (i) in the distal cylindrical section is between 60° and 75° and (ii) in the proximal cylindrical section is between 65° and 75°. Yodfat teaches two sections having separate braiding angles which allow for customization of the porosity along the length of the stent. Yodfat teaches the angle between the filaments is “in the vicinity of 90º” (See paragraphs [0090]-[0091]).
As disclosed, the braiding angle is a result effective variable which assists with desired porosity of the stent. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying McCullagh to have the braiding angle (i) in the distal cylindrical section is between 60° and 75° and (ii) in the proximal cylindrical section is between 65° and 75°, 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 cone angle 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 26, McCullagh teaches the stent required by claim 14 as set forth above but does not expressly teach the porosity of the proximal cylindrical section differs from the porosity of the distal cylindrical section by at least 2% and wherein the porosity of the proximal cylindrical section is one of larger or smaller than the porosity of the distal cylindrical section.
Yodfat teaches an analogous stent which has separate zones with different porosities for each (See Figs. 8-9). Yodfat teaches the proximal section (l2) has a higher porosity than the distal section (l1). (See Fig. 9; paragraphs [0090], [0091]). Yodfat teaches varying the porosity allows for a more effective stent. Yodfat also teaches porosity is a function of the braiding angle and total number of wires. (See paragraphs [0091]-[0097]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the stent as taught by McCullagh such that the distal cylindrical section has a braiding angle that is different (larger or smaller) than that of the proximal cylindrical section as taught by Yodfat since it is known in the art to modify the braiding angle of the wires in order to achieved the desired porosity profile for the stent depending upon the particular deployment criteria for a particular patient. Additionally, as stated in MPEP §2144.05(II)(A): “It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)
As disclosed, having the proximal section have a different porosity than the distal section is a result effective variable which assists with proper coverage of soft plaque in vessels which are narrowed along their length. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in further modifying McCullagh to have the difference in porosity of the proximal and distal sections be at least 2%, 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 difference in porosity between the proximal and distal sections 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 27, McCullagh teaches a stent (100) comprising: a tubular braided mesh of wires (See Fig. 1B), each wire respectively helically wound about a longitudinal axis of the braided mesh (See Fig. 1B) and arranged to cross over and under each other wire (See Fig. 1B; paragraph [0038]), wherein in a non-operational state2, the braided mesh has a proximal cylindrical section (120) and a distal cylindrical section (110) connected by a transitional section (130), and wherein the proximal cylindrical section has a cross sectional diameter (See Fig. 1B; paragraph [0007] and [0022]) and a porosity (See paragraph [0054]) that are different than that of the distal cylindrical section. McCullagh further teaches the proximal cylindrical section (120) has a larger cross sectional diameter than that of the distal cylindrical section (110) (See Fig. 1B; paragraph [0022] and [0028]).
McCullagh does not expressly teach the proximal cylindrical section has a higher porosity than the distal cylindrical section or that the distal cylindrical section has a braiding angle that is different than that of the proximal cylindrical section.
Yodfat teaches an analogous stent which has separate zones with different porosities for each (See Figs. 8-9). Yodfat teaches the proximal section (l2) has a higher porosity than the distal section (l1). (See Fig. 9; paragraphs [0090], [0091]). Yodfat teaches varying the porosity allows for a more effective stent. Yodfat also teaches porosity is a function of the braiding angle and total number of wires and further teaches the distal section has a different braiding angle than the proximal section. (See paragraphs [0091]-[0097]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the stent as taught by McCullagh such that the distal cylindrical section has a braiding angle that is different than that of the proximal cylindrical section and the proximal section has a higher porosity than the distal section as taught by Yodfat since it is known in the art to modify the braiding angle of the wires in order to achieved the desired porosity profile for the stent depending upon the parameters of the desired treatment location. Further, it is known in the art that varying the braiding angle of a part of a stent will result in a change in the porosity which can be adjusted for the desired parameters of a particular stent. Additionally, as stated in MPEP §2144.05(II)(A): “It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)
Regarding claim 28, modified McCullagh teaches the stent required by claim 27 as set forth above and further teaches the distal cylindrical section comprises a distal longitudinal end of the braided mesh wherein the wires form end loops (140). (See Fig. 1B; paragraphs [0037], [0048], and [0049]).
Regarding claim 29, modified McCullagh teaches the stent required by claim 27 as set forth above and further teaches the distal longitudinal end is conically flared. (See Figs. 1A & 1B; paragraph [0047] which states both ends of the stent “may be flared as is well known in the art”.)
Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date to have the distal longitudinal end of the stent be conically flared in addition to the proximal end of the stent being conically flared since it is known in the art to have flared ends to provide increased radial strength and counteract a known end-effect of braided stent architecture.
Regarding claim 30, modified McCullagh teaches the stent required by claim 27 as set forth above and further teaches the transitional section (130) is conical in shape. (See Fig. 1B; paragraphs [0023] and [0045])
Regarding claim 32, modified McCullagh teaches the stent required by claim 27 as set forth above and further teaches porosity of the proximal cylindrical section differs from the porosity of the distal cylindrical section and wherein the porosity of the proximal cylindrical section is one of larger or smaller than the porosity of the distal cylindrical section. As noted above, McCullagh as modified to include the teachings of Yodfat results in the proximal section having a different (larger) porosity than the distal section.
Regarding claim 33, modified McCullagh teaches the stent required by claim 27 as set forth above and further teaches the braided mesh has between 18 and 30 wires. (See paragraph [0037] which states the braid has 24 wires)
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited McCullagh et al (US PG Pub 2004/0098099) in view of Frid (US Pat. No. 5,741,333).
Regarding claim 17, McCullagh teaches the stent required by claim 14 as set forth above but is silent as to the specific cross section diameter when the stent is in the non-operational3 (resting) state.
Frid teaches and analogous implantable stent with a proximal section, a distal section and a transitional section between where the sections have different cross sectional diameters. (See Fig. 1) Frid teaches luminal prostheses having an at rest diameter of 55-60 mm at the ends and 25-30 mm at the center (See Col. 3, lines 38-43).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the cross section diameter of the proximal cylindrical section of the stent as taught by McCullagh to be at least 5mm as taught by Frid since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, F.2d 459, 105 USPQ 237 (CCPA 1955). Additionally, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Additionally, there is a finite range of sizes for implantable stents to have based on human anatomical vasculature sizes. See also MPEP §2144.04(IV)(A).
Claim(s) 21 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over applicant cited McCullagh et al (US PG Pub 2004/0098099).
Regarding claim 21, McCullagh teaches the stent required by claim 20 as set forth above and further teaches the distal longitudinal end is conically flared. (See Figs. 1A & 1B; paragraph [0047] which states both ends of the stent “may be flared as is well known in the art”.)
Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date to have the distal longitudinal end of the stent be conically flared in addition to the proximal end of the stent being conically flared since it is known in the art to have flared ends to provide increased radial strength and counteract a known end-effect of braided stent architecture.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited McCullagh et al (US PG Pub 2004/0098099) as applied to claim 14 above and further in view of Düring et al (US PG Pub 2017/0071766).
Regarding claim 23, McCullagh teaches the stent required by claim 14 as set forth above but is silent as to the particular angle of the tapered transitional section having a cone angle of between 5º and 20º.
Düring teaches an analogous stent with a proximal end having a larger diameter (17) and a distal end with a smaller diameter (16) which are connected by a tapered conical section (See Figs. 1 and 8). Düring teaches the tapered section has a conical angle of between 2º and 20º (See paragraph [0047]).
As disclosed, the cone angle of the transition section is a result effective variable which assists with desired blood flow into branching blood vessels. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying McCullagh to have the tapered transition section has a cone angle of between 5º and 20º as taught by Düring, 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 cone angle 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 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited McCullagh et al (US PG Pub 2004/0098099) in view of applicant cited Yodfat (US PG Pub 2004/0199243).
Regarding claim 25, McCullagh teaches the stent required by claim 14 as set forth above but is silent as to the specific wire diameter.
Yodfat teaches an analogous braided wire stent featuring regions with different porosities and further teaches the wires used to form the stent have a wire diameter of between 50µm and 120µm. (See Paragraph [0104] which states the diameter of the wires are between 60µm and 400µm).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the wires forming the stent as taught by McCullagh have a wire diameter between 50µm and 120µm since wires of such a dimension are known in the art to be suitable for the formation of braided stents. Such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, F.2d 459, 105 USPQ 237 (CCPA 1955). Additionally, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See also MPEP §2144.04(IV)(A). 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)
Claim 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited McCullagh et al (US PG Pub 2004/0098099) in view of applicant cited Yodfat (US PG Pub 2004/0024416) as applied to claim 27 above and further in view of Düring et al (US PG Pub 2017/0071766).
Regarding claim 31, modified McCullagh teaches the stent required by claim 27 as set forth above but is silent as to the particular angle of the tapered transitional section having a cone angle of between 5º and 20º.
Düring teaches an analogous stent with a proximal end having a larger diameter (17) and a distal end with a smaller diameter (16) which are connected by a tapered conical section (See Figs. 1 and 8). Düring teaches the tapered section has a conical angle of between 2º and 20º (See paragraph [0047]).
As disclosed, the cone angle of the transition section is a result effective variable which assists with desired blood flow into branching blood vessels. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in further modifying McCullagh to have the tapered transition section has a cone angle of between 5º and 20º as taught by Düring, 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 cone angle 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
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 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims.
2 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims.
3 Based on applicant’s specification, “non-operational” is defined as “This is the case for the non-operational state of the stent, in which no force is applied to the stent, i.e. it is not exposed to any external forces. The stent is expanded in the non-operational state.”
Prosecution Insights