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 Arguments
Applicant's arguments filed 12/15/2025 have been fully considered but they are not persuasive. Regarding the objection to the drawings, applicant argues par. 181 of the instant application discloses a polynomial function such as a 4th order polynomial function. The examiner never questioned support for a fourth order polynomial function. The issue is that there are two x4 and no x2 in the upper right equation of fig.16C, which appears to be in error. For example, if the second instance of x4 is not in error, why wouldn’t the equation be simplified as is standard? See annotated fig.16C below which further clarifies the issue.
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Regarding the rejection of claims 1-12 under 35 U.S.C. 102(a)(1) as being anticipated by Gregorich, applicant disagrees with the examiner’s characterization of the claim limitation “defined by a polynomial function” as a product-by-process limitation. Applicant argues that rather than describing a manufacturing process, the limitation describes a specific structural relationship between bridge position and bridge length, more specifically, the polynomial function mathematically defines the dimensional values of bridge lengths at each position along the longitudinal axis. This is not persuasive because, no actual “dimensional values of bridge lengths” are claimed. Applicant argues Gregorich does not appear to disclose bridge lengths “defined” by a polynomial function and while Gregorich may define bridges of varying lengths, does not appear to provide a disclosure that the lengths are defined by any polynomial function or based on the overall length of the stent, as recited in claim 1 of the present application. Applicant further argues the characterization that the three bridge lengths can be part of a polynomial function conflates mathematical curve-fitting with a structural definition. This is not persuasive because as applicant points out “any three points may be retrospectively fitted to some polynomial curve”. Therefore, the stent of Gregorich has the same structure claimed since the three bridge lengths of Gregorich are defined by a polynomial function that is based at least on a length of the stent. Applicant argues the three points of Gregorich are not defined by that polynomial function, meaning that the polynomial function “dictates” and “determines” the specific length values. This is not persuasive because the structure of the stent of Gregorich is identical to the structure claimed. All of applicant’s arguments appear to be directed to a mental step in designing the stent, for instance applicant states that the polynomial function “dictates and determines” the specific length values. But, the stent of Gregorich has specific length values that are defined by a polynomial function. In other words, a person would not be able to structurally distinguish between a stent designed using a polynomial function and a stent that defines a polynomial function as in Gregorich. Further, no specific polynomial function is claimed, therefore any stent having three different bridge lengths as claimed meets the claim since such a stent inherently defines a polynomial function as claimed.
Regarding the rejection of claims 13-20 under 35 U.S.C. 103 as being unpatentable over Gregorich in view of Tischler applicant argues Tischler discloses a generic intended use statement, rather than a stent specifically configured and structurally adapted for treating atherosclerosis in arterial vasculature as required by claims 13-20. First, “for treating atherosclerosis” is only recited in the preamble of claim 13. Claim 13 generically requires commonplace steps of collapsing, delivering, and deploying the stent of claim 1 which is disclosed by Gregorich. Both Gregorich and Tischler disclose stents and it is common knowledge in the art that stents are used to treat atherosclerosis. Applicant argues teaching treatment of a symptom (stenosis/narrowing) does not teach the treatment of the underlying disease and is insufficient to transform Gregorich’s stent into a stent specifically configured for treating atherosclerosis in arterial vasculature. This argument is not persuasive since a stent that treats stenosis, also treats atherosclerosis. A simple google search of treatment of atherosclerosis lists stenting. The claim requires no steps beyond basic stent deployment for “treating atherosclerosis”. Applicant’s specification does not disclose any particular features of the stent or steps that treat underlying disease as argued. Instead, applicant’s specification states in par.160 that “The stents described herein can be configured to treat vascular blockage due, for example, to atherosclerosis and improve blood flow along various vasculature”. No additional steps of treating atherosclerosis are disclosed or are required by the claims, and Tischler’s teaching of treating stenosis is the same as applicant’s use described in par.160 of the specification. Therefore, since Tischler teaches placing a stent in an artery for treating stenosis, which virtually all stents are used to do, the examiner maintains Tischler teaches using a stent for treating atherosclerosis.
Drawings
The drawings are objected to because fig. 16C appears to have an error in the equation. “-0.0074x4“ appears to be in error for -0.0074x2. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gregorich US 2007/0010872 (hereafter referred to as Gregorich).
Regarding claim 1, Gregorich discloses a stent 100 capable of treating atherosclerosis in arterial vasculature, the stent comprising: an elongated tubular body that is configured to form a collapsed configuration and an expanded configuration (par.87), the elongated tubular body extending along a longitudinal axis (axis between ends 104 and 108 in fig.9) and comprising: a plurality of strut rings 112 extending circumferentially around the longitudinal axis; and a plurality of bridges 120 that are each configured to connect two adjacent strut rings of the plurality of strut rings (fig.9), the plurality of bridges comprising: a first set of at least two bridges 120a, 120b, or 120c each having a first length and connecting a first pair of strut rings of the plurality of strut rings, the first set of at least two bridges at a first position along the longitudinal axis (fig.9; par.63); a second set of at least two bridges 120b, 120c, or 120d each having a second length and connecting a second pair of strut rings of the plurality of strut rings, the second length being longer than the first length, the second set of at least two bridges at a second position along the longitudinal axis (fig.9; par.63); a third set of at least two bridges 120c, 120d, or 120e each having a third length and connecting a third pair of strut rings of the plurality of strut rings, the third length being longer than the second length, the third set of at least two bridges at a third position along the longitudinal axis (fig.9; par.63); and wherein the first length at the first position, the second length at the second position, and the third length at the third position are defined by a polynomial function that is based at least on a length of the stent (this limitation is directed to a product by process limitation; see MPEP 2113 which discusses that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product may be made by a different process; since Gregorich discloses at least three different lengths of the bridges and the stent inherently has a length, the stent of Gregorich meets the limitation of being defined by a polynomial function based on at least the length of the stent). The last limitation of the claim is broad and does not impose any additional structure to the stent. In other words, any stent having a third bridge longer than a second bridge longer than a first bridge meets the claim as the three bridge lengths are inherently part of a polynomial function based on the length of the stent.
Regarding claims 2, 3 and 6, see fig.9 for both the proximal and distal ends including open cells. No specific structure is defined for an “open cell” therefore the examiner considers the v-shaped ends open cells.
Regarding claims 4 and 5, fig.9 shows the middle of the stent comprising only closed cells.
Regarding claim 7, see fig.9 which shows all of the bridges including a non-linear shape.
Regarding claim 8, see fig.9 and par.63 for the bridges 124 increasing in length from at least a proximal end 104 through the middle section.
Regarding claim 9, see fig.9 for the struts of rings 112 being equal lengths.
Regarding claim 10, par.78 discloses the rings 112 can increase in amplitude (which includes an increased length of the struts in 112 as shown in fig.11) in combination with the bridge/connector struts 124 increasing in length from the center of the stent to the ends. From the middle to the ends is considered “along the stent”.
Regarding claim 11, see fig.9 for bridges 120a-e increasing in length along the length of the stent to the end 108.
Regarding claim 12, fig.9 shows first bridges 120a at a proximal end 104 of the stent and third bridges 120e at the distal end of the stent.
Claim Rejections - 35 USC § 103
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.
Claims 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gregorich as applied above, and further in view of Tischler et al. 8,348,993 (hereafter referred to as Tischler).
Regarding claim 13, Gregorich discloses the stent of claim 1 as discussed above, and Gregorich further discloses collapsing the stent for insertion and expanding the stent at a desired bodily location (par.87). However, Gregorich does not specifically disclose that the stent is inserted into arterial vasculature for treating atherosclerosis.
Tischler teaches a method of using a stent, in the same field of endeavor, wherein the stent is placed in an artery for the purpose of treating stenosis of the artery (col. 1, lines 43-47; col.13, lines 53-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to collapse and expand the stent of Gregorich in an artery as taught by Tischler in order to treat stenosis of the artery which is a well-known and conventional use of stents. The method of Gregorich in view of Tischler which includes deploying the stent of Gregorich in an artery to treat stenosis as taught by Tischler includes the same method of the instant application as disclosed in par.160 of the instant application and therefore is considered to inherently as least somewhat treat atherosclerosis in the same manner as the application (i.e. treat vascular blockage/stenosis and improve blood from along various vasculature).
Regarding claims 14 and 16, see fig.9 of Gregorich for both the proximal and distal ends including open cells. No specific structure is defined for an “open cell” therefore the examiner considered the v-shaped ends open cells.
Regarding claim 15, fig.9 of Gregorich shows the middle of the stent comprising only closed cells.
Regarding claim 17, see fig.9 of Gregorich which shows all of the bridges including a non-linear shape.
Regarding claim 18, see fig.9 and par.63 of Gregorich for the bridges 124 increasing in length from at least a proximal end 104 through the middle section.
Regarding claim 19, par.78 of Gregorich discloses the rings 112 can increase in amplitude (which includes an increased length of the struts in 112 as shown in fig.11) in combination with the bridge/connector struts 124 increasing in length from the center of the stent to the ends. From the middle to the ends is considered “along the stent”.
Regarding claim 20, see fig.9 of Gregorich for bridges 120c-e increasing in length from the midline of the stent to the end 108.
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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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