Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Regarding applicants’ arguments in response to the drawing and claim objections, arguments are found persuasive, the objections of record are withdrawn.
Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive. Applicant argues that the combination of references does not teach the amended limitations, examiner disagrees, see new rejection below.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 85-104 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Frantzen (US 5741327 A) in view of Berra (US 20050049674 A1).
Regarding claim 85, Frantzen teaches a stent (abstract) comprising: a plurality of proximal and distal apices (col 6-7, lines 64-10, crests and troughs) connected by a plurality of generally straight portions (col 6-7, lines 64-10, inflection region), where each proximal apex comprises a first curved portion (col 6-7, lines 64-10, crest) and each distal apex comprises a second curved portion (col 6-7, lines 64-10, trough), where the first curved portion and the second curved portion each comprises at least one radius of curvature (col 6-7, lines 64-10), and a first radius of curvature of at least one of the proximal apices is greater than a second radius of curvature of at least one of the distal apices (col 6-7, lines 64-10) and where each proximal apex comprises first and second opposed shoulder curved portions (see annotated figure 5).
Frantzen is silent to the exact dimensions of the first radius of curvature, however Berra teaches a stent graph (abstract) where a first radius of curvature of at least one of the proximal apices is greater than a second radius of curvature of at least one of the distal apices ([0167], the proximal apices is approximately 1.5mm) and a radius of curvature of a proximal apices is greater than 2.0 mm ([0167], “approximately” 1.5 also understood to teach values “greater than” 1.5, especially when the disclosure discusses a wider curvature for “preventing perforation”). Additionally, it is held that discovering optimum values for effective variables involves only routine skill in the art (MPEP 2144.05).
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 device taught by Frantzen by applying the teaching of the radius of curvature as taught by Berra, in order to prevent the stent from puncturing tissue ([0167]).
Frantzen is also silent to the exact dimensions of the shoulder curvature; however, Berra teaches a stent graph (abstract) wherein a curved strut has a radius of curvature of from about of 0.5 mm to about 5.0 mm ([0167], curved apices radius can be 0.5 mm or 1.5 mm).
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 device taught by Frantzen by applying the teaching of a curved stent struts radius of curvature as taught by Berra, in order to prevent the stent from puncturing tissue ([0167]).
PNG
media_image2.png
351
546
media_image2.png
Greyscale
Annotated figure 5
Regarding claim 92, Frantzen teaches a stent (abstract) comprising: a plurality of proximal and distal apices (col 6-7, lines 64-10, crests and troughs) connected by a plurality of generally straight portions (col 6-7, lines 64-10, inflection region), where each proximal apex comprises a first curved portion (col 6-7, lines 64-10, crest) and each distal apex comprises a second curved portion (col 6-7, lines 64-10, trough), where the first curved portion and the second curved portion each comprises at least one radius of curvature (col 6-7, lines 64-10), and a first radius of curvature of at least one of the proximal apices is greater than a second radius of curvature of at least one of the distal apices (col 6-7, lines 64-10) and where each proximal apex comprises first and second opposed portions (see shoulder portion in annotated figure 5) and where a proximal apex of the plurality of proximal apices comprises a third curved portion having a third radius of curvature (a shoulder would have a third radius of curvature, see annotated figure 5).
Frantzen is silent to the exact dimensions of the radius of curvature, Berra teaches a stent graph (abstract) where the second radius of curvature of one of the distal apices is from 0.6 mm to 1.5 mm ([0063], 0.5 is about 0.6), and where a ratio of the second radius of curvature to the first radius of curvature is about 1:2.6 to about 1:18 ([0063], 1:3 is about 1:2.6), (MPEP 2144.05).
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 device taught by Frantzen by applying the teaching of the radius of curvature as taught by Berra, in order to prevent the stent from puncturing tissue ([0167]).
Frantzen is also silent to the exact dimensions of the third curvature; however, Berra teaches a stent graph (abstract) wherein a curved strut has a radius of curvature of from about of 0.5 mm to about 5.0 mm ([0167], curved apices radius can be 0.5 mm or 1.5 mm).
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 device taught by Frantzen by applying the teaching of a curved stent struts radius of curvature as taught by Berra, in order to prevent the stent from puncturing tissue ([0167]).
Regarding claim 99, Frantzen teaches a stent (abstract) comprising: a first stent having a plurality of proximal and distal apices (col 6-7, lines 64-10, crests and troughs) connected by a plurality of generally straight portions (col 6-7, lines 64-10, inflection region), where each proximal apex of the first stent comprises a first curved portion (col 6-7, lines 64-10) and each distal apex of the first stent comprises a second curved portion (col 6-7, lines 64-10 ), where the first curved portion and the second curved portion each comprises at least one radius of curvature (col 6-7, lines 64-10), and a first radius of curvature of at least one of the distal apices of the first stent is greater than a second radius of curvature of at least one of the proximal apices of the first(col 6-7, lines 64-10, one radius of curvature is bigger than the other, the structure is the same regardless of how the device is oriented and which apices is considered distal) and where each proximal apex of the a stent comprises a third curved portion and each distal apex of a stent comprises a fourth curved portion and where the third curved portion and the fourth curved portion each comprises at least one radius of curvature (proximal and distal shoulders would have a third and fourth radius of curvature, see annotated figure 5).
Frantzen doesn’t exactly teach the specifics of a second stent. Berra teaches a stent graph (abstract) where each stent ring is considered a stent and wherein there is a second stent considered present (abstract) that has a plurality of proximal and distal apices connected by a plurality of generally straight portions (fig 1, [0146]). Frantzen further teaches where each stent ring has a third curved portion and the fourth curved portion (col 6-7, lines 64-10, crest and troughs) each comprises at least one radius of curvature (col 6-7, lines 64-10), and a third radius of curvature of at least one of the proximal apices of the second stent is less than a fourth radius of curvature of at least one of the distal apices of the second stent (col 6-7, lines 64-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of multiple stents of Berra to the device taught by Frantzen, in order to combining prior art elements according to known methods to yield predictable results of creating a desired framework.
Frantzen is silent to the exact dimensions of the first radius of curvature; however, Berra teaches a stent graph (abstract) a radius of curvature of a distal apices is greater than 2.0 mm ([0167], “approximately” 1.5 also understood to teach values “greater than” 1.5, especially when the disclosure discusses a wider curvature for “preventing perforation”). Additionally, it is held that discovering optimum values for effective variables involves only routine skill in the art (MPEP 2144.05).
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 device taught by Frantzen by applying the teaching of the radius of curvature as taught by Berra, in order to prevent the stent from puncturing tissue ([0167]).
Frantzen is silent to the exact dimensions of the radius of curvature, Berra teaches a stent graph (abstract) where the second radius of curvature of one of the distal apices of the first stent is from 0.6 mm to 1.5 mm, and where a ratio of the second radius of curvature to the first radius of curvature is about 1:2.6 to about 1:18 (the structure is the same regardless of how the device is oriented and which apices is considered distal ([0063], 1:3 is about 1:2.6), (MPEP 2144.05).
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 device taught by Frantzen by applying the teaching of the radius of curvature as taught by Berra, in order to prevent the stent from puncturing tissue ([0167]).
Regarding claim 86, 93, and 100, Frantzen is silent to the exact dimensions of the radius of curvature. Berra teaches a stent graph (abstract) with dimensions for radius of curvature ([0063], 0.5 and 1.5).
It would have been obvious to modify the values for first radius of curvatures so that it is between 4 mm - 9 mm, since it has been held that discovering an optimum value of a result effective variable only involves routine skill in the art (MPEP 2144.05). Berra has established that having a larger radius of curvature than an attachment end is beneficial in anchoring, placing, and reducing trauma ([0165-167])). It has further been held that where general conditions of a claim are disclosed in prior art, discovering the optimal ranges involves only ordinary skill in the art (MPEP 2144.05). The ranges that would work for preventing trauma would be obvious to one of ordinary skill in the art, no criticality has been assigned to the broad range in the applicants claims (broad range of 1:26 to 1:18).
Regarding claim 87, Frantzen is silent to the exact dimensions of the radius of curvature, Berra teaches a stent graph (abstract) where the second radius of curvature of one of the distal apices is from 0.5 mm to 1.5 mm ([0063], 0.5), and where a ratio of the second radius of curvature to the first radius of curvature is about 1:2.6 to about 1:18 ([0063], 1:3 is about 1:2.6), (MPEP 2144.05).
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 device taught by Frantzen by applying the teaching of the radius of curvature as taught by Berra, in order to prevent the stent from puncturing tissue ([0167]).
Regarding claim 88, 94, 101, Frantzen is silent to the exact dimensions of the radius of curvature. Berra teaches a stent graph (abstract) with dimensions for radius of curvature ([0063], 0.5 and 1.5).
It would have been obvious to modify the values for first and second radius of curvatures so that they are 1 mm and 6 mm since it has been held that discovering an optimum value of a result effective variable only involves routine skill in the art (MPEP 2144.05). Berra has established that having a larger radius of curvature than an attachment end is beneficial in anchoring, placing, and reducing trauma ([0165-167])). It has further been held that where general conditions of a claim are disclosed in prior art, discovering the optimal ranges involves only ordinary skill in the art (MPEP 2144.05). The ranges that would work for preventing trauma would be obvious to one of ordinary skill in the art, no criticality has been assigned to the broad range in the applicants claims (broad range of 1:26 to 1:18).
Regarding claim 89, 96, and 102, Frantzen teaches further comprising a generally continuous plurality of proximal and distal apices (fig 5), the outer surfaces of which define a cylinder having a generally consistent circumference (fig 1).
Regarding claim 90 and 103, Frantzen teaches where each of the proximal apices are circumferentially offset from the distal apices (fig 5).
Regarding claim 91, 98, and 104, Frantzen teaches further comprising a generally continuous plurality of proximal and distal apices, the outer surfaces of which define a frustum of a cone (fig 5).
Regarding claim 95, Frantzen does not disclose a graft. Berra teaches a stent graph (abstract) further comprising proximal and distal ends (see top/bottom ends in fig 8-9), where at least one of the distal apices of the stent is attached to the graft ([0163]).
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 device taught by Frantzen by including the graft as taught by Berra, in order to treat a diseased blood vessel ([0009]).
Regarding claim 97, Frantzen teaches further where each proximal apex comprises first and second opposed portions (see shoulder portion in annotated figure 5).
Frantzen is also silent to the exact dimensions of the opposed portion curvatures; however, Berra teaches a stent graph (abstract) wherein a curved strut has a radius of curvature of from about of 0.5 mm to about 5.0 mm ([0167], curved apices radius can be 0.5 mm or 1.5 mm).
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 device taught by Frantzen by applying the teaching of a curved stent struts radius of curvature as taught by Berra, in order to prevent the stent from puncturing tissue ([0167]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 8:30PM-4:30PM EST M-F (occasionally off Fridays).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/H.L.P./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
Prosecution Insights