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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/18/2026 has been entered.
Response to Arguments
Applicant's arguments filed 5/18/2026 have been fully considered but they are not persuasive. Applicant’s invention is the spacing of stent elements. Claim 1 requires after implantation, a distance between each stent element is greater than or equal to the equation
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. For claim 1, wherein D is from 3.0 to 8.0 mm and theta is 8.473 degrees, the equation results in greater than or equal to 0.049 mm for 3.0 mm diameter. The examiner asks that applicant work out all equations clearly showing the results in their response. Papp et al teaches:
[0134] FIG. 5 depicts a projection of axial segments 351, 352, and 353 disposed over a balloon 350 in a deflated configuration. Axial segments are crimped tightly over the balloon in a reduced diameter configuration. A crimped configuration generally may correspond to the inner surface of the segments in contact with the outer surface of a balloon. The axial segments are spaced apart by a distance, size, or width Lg, which is the gap between segments. Lg can change during inflation and deployment of the segments to a deployed diameter due to movement of the segments and axial contraction or shortening of the segments. Lg at deployment should be large enough to avoid interference or contact of the segment ends during bodily movements. Lg at deployment should be large enough so that there is axial stability and the support of the vessel is continuous. In exemplary embodiments, the segments when deployed are spaced apart by 0.5 to 2 mm, or more narrowly, 0.5 to 1 mm, 1 to 2 mm, 2 to 3 mm. The required Lg is determined by the anatomy that the segmented scaffold will be deployed in to, i.e., in the SFA it will need to be greater than for the Iliac where vessel compression and bending are virtually zero. In general, Lg is higher for anatomies with higher vessel compression and bending.
As taught in par. 0135, clearly at least 0.5 mm fulfills is greater than or equal to 0.049 mm.
It is the examiner’s position that par. 0134 of Papp et al is applicant’s invention only written using a mathematical equation to merely produce a known distance between stent elements as taught by Papp et al; this is not inventive.
Regarding at least claims 19 claiming ((LEC+GEC-GC)/(E-1)) + G, in response to this action, please calculate the answers for the all given variables. Claim 20 depends from claim 19 claiming distance between each stent element in the expanded state is greater than 3 mm. Therefore, it is inherent when Papp et al teaches greater than 3 mm both claims 19 and 20 are fulfilled.
Claims 19-20 and 25-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
Claims 19 and 25 claim the distance between each stent element greater than or equal to ((LEC+GEC-GC)/(E-1)) + G wherein variable E is undefined and is considered indefinite.
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.
Claims 14-17, 19-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Papp et al (2013/0268045).
Papp et al teaches a device for placement within a blood vessel to maintain or enhance blood flow through the blood vessel, the device comprising:
multiple, balloon-expandable, stent elements (at least 351, 352, 353 and figures 15A-15B) configured to be implanted in the blood vessel as a multi-element stent;
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wherein the stent elements are positioned serially along a longitudinal length of a balloon (as shown above and par. 0134) and do not touch one another in an unexpanded state. Also, see figures 5, 8A-19D.
Regarding, “wherein the stent elements are spaced such that after implantation the stent elements do not touch one another at a target vessel location during skeletal movement”, Pappa et al teaches:
[0134] FIG. 5 depicts a projection of axial segments 351, 352, and 353 disposed over a balloon 350 in a deflated configuration. Axial segments are crimped tightly over the balloon in a reduced diameter configuration. A crimped configuration generally may correspond to the inner surface of the segments in contact with the outer surface of a balloon. The axial segments are spaced apart by a distance, size, or width Lg, which is the gap between segments. Lg can change during inflation and deployment of the segments to a deployed diameter due to movement of the segments and axial contraction or shortening of the segments. Lg at deployment should be large enough to avoid interference or contact of the segment ends during bodily movements. Lg at deployment should be large enough so that there is axial stability and the support of the vessel is continuous. In exemplary embodiments, the segments when deployed are spaced apart by 0.5 to 2 mm, or more narrowly, 0.5 to 1 mm, 1 to 2 mm, 2 to 3 mm. The required Lg is determined by the anatomy that the segmented scaffold will be deployed in to, i.e., in the SFA it will need to be greater than for the Iliac where vessel compression and bending are virtually zero. In general, Lg is higher for anatomies with higher vessel compression and bending.
[0201] This spacing may be from 1-2 mm, 2-5 mm or even in a different location within the vessel.
Therefore, Pappa et al teaches the stent elements are spaced such that after deployment (after implantation), in an expanded state, the stent elements do not touch one another at a target vessel location during skeletal movement at a Spacing distance Lg.
Regarding after implantation, a distance between each stent element is greater than or equal to:
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; wherein D is from 3.0 to 8.0 mm and theta is 8.473 degrees, the equation results in a distance between stent elements greater than or equal to 0.049 mm for D = 3.0 mm. As taught in par. 0135, clearly at least 0.5 mm fulfills is greater than or equal to 0.049 mm.
Regarding theta is 8.473 degrees, the stent elements are capable of this functional language. The equation
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has very little affect on the spacing only putting in a lower separation distance of 0.049 mm of a range. Applicant is reminded that the claims are directed to “a device” and not a method of using said device. The distance after expansion does not have to equal the unclaimed spacing on the balloon due to stent shortening during expansion.
Regarding, wherein the D is from 3.0 to 8.0 mm; see at least par. 0244 teaching the stent element is cut from a 7 mm tube which results in a stent element diameter of 7 mm. Also, see par. 0138 teaching varying deployed diameter to length ratios. “This diameter:length ratio can be less than a 1:1 ratio, a 1:1 ratio, a 1:1.5 ratio or a 1:2 ratio or greater. The ratio is dependent among other things on the size of the nonpulsatile forces at the delivery site. For example, the Lg at deployment can be less than 2 or 3 mm”.
[0122] Ls is the length of the axial segment. Ls may be 3 to 6 mm, 6 to 8 mm, 8 to 10 mm, 10 to 12 mm, or greater than 12 mm.
A 1:1 ratio of a 6 mm long (Ls) equates to a 6 mm diameter fulfilling the claimed diameter range.
Claim 15 and 22, referring to figures 5, 8A-19D, the drawings show the stent element are the same length Ls. Note at least par. 0122. See MPEP 2125.
Claims 16 and 23, referring to figures 5, 7-19D, the drawings show the stent element are equally spaced. Note at least par. 0147 teaching the pre-pillowed sections have a width and par. 0134. See MPEP 2125.
Claims 17 and 24, par. 0134 teaches each of the stent elements are separated a distance of at least 2 to 3 mm when the balloon is deployed. Also, see par. 0201 teaching a spacing of 2-5 mm which is larger after implantation.
Claims 19 and 25 claim the distance between each stent element greater than or equal to ((LEC+GEC-GC)/(E-1)) + G comprising an undefined variable E. However, depending claims 20 and 26 claim the distance between each stent element is greater than 3 mm which fulfills claims 19 and 25. Therefore, it is inherent when Papp et al teaches greater than 3 mm, claims 19-20 and 25-26 are fulfilled.
Claim 21, differs from claim 14 defining theta as 25.609 degrees which produces a distance between each stent of greater than or equal to 0.442 mm for D = 3.0 mm. See discussion for distance between each stent element for at least claims 14, 17 and 24.
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 19-20 and 25-26 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.
Claims 19 and 25 claim the distance between each stent element greater than or equal to ((LEC+GEC-GC)/(E-1)) + G wherein variable E is undefined and is considered indefinite.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Argentine (9,987,122) – see at least 108. The claims do not exclude a “device” comprising a graft.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/Primary Examiner, Art Unit 3774
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