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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-23 is/are pending. Claim(s) 10, 15-17, 19, and 22-23 is/are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Species 1-1, 2-1, 3-1, and 4-2 in the reply filed on 11/14/2025 is acknowledged.
Claims 10, 15-17, 19, and 22-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/14/2025.
The Examiner notes claim 19 is part of non-elected species 3-2.
Information Disclosure Statement
The information disclosure statement filed 1/23/2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the lined through citation was not provided. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
All non-lined through citations were considered.
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 1-9, 11-14, 18, and 20-21 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 1, line 8 and Claim 13 each recites “individual struts”. It is unclear if these are the same individual struts as introduced in line 2 or a different set of individual struts or all of the possible struts.
Claim 2, line 1 and Claim 14 each recites “individual struts”. It is unclear if these are the same individual struts1 as introduced in either instance in claim 1 or a different set of individual struts or all of the possible struts.
Claim 3, line 1 recites “adjacent struts”. It is unclear if these are the same adjacent struts as introduced in claim 1.
The term "about" in each of claims 4, 5, 9, 11, 12, 20, and 21 is a relative term which renders the claim indefinite. The term "about" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure provides no metric for determining the bounds of “about” (such as standard deviation or another metric). Therefore, this term is indefinite.
Claims 11-12 each recite “a radially outward force”. It is unclear if this is the same or different radially outward force as introduced previously in claim 1.
Claim(s) 6-8 and 18 are rejected as dependent from a rejected claim.
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.
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.
Prior Art Used in the Rejections Below
Stoeckel (D. Stoeckel, A. Pelton, T. Duerig, “10 - Self-expanding Nitinol stents for the treatment of vascular disease”, Editor(s): Takayuki Yoneyama, Shuichi Miyazaki,
In Woodhead Publishing Series in Biomaterials, Shape Memory Alloys for Biomedical Applications, Woodhead Publishing, 2009, Pages 237-256.)
Claim(s) 1-5, 9, 11-14, and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by (Lombardi) (US 6,579,314 B1) in view of Stoeckel.
Regarding Claim 1, Lombardi teaches a radially self-expanding stent (e.g. Lombardi, column 6, lines 22-40 indicate the memotherm stent is a radially self-expanding stent) comprising:
the stent is configured to produce an outward radial force (e.g. Lombardi, column 6, lines 22-40, the stent self-expands and thus has a radially outward force to at least the fully expanded configuration) with the stent having a diameter greater than or equal to a compact diameter and less than or equal to a fully expanded diameter (self-expanding stents transition from collapsed to fully expanded; any diameter between the compact diameter and up to the fully expanded diameter meets this requirement), the outward radial force depending at least in part on the wall thickness of individual struts (this limitation is inherently met because the amount of force needed to expand outward depends on the amount of material it is pushing outward and thus for stents includes the radial thickness) and configured to be sufficient to resist elastic recoil for aortic coarctation in a subject (e.g. Lombardi, column 6, lines 22-40; the pulling force is the crimping force, which is either 6.3 N or 3.5 N; since the crimping force must balance the expansion force to create a compacted diameter, the expansion force is the same as the crimping/pulling force; Applicant’s original specification indicates at least expansion forces in the range of 1N to 5N are appropriate for the function of their invention; therefore, at least S2 is able to perform the claimed function).
Lombardi discloses the invention substantially as claimed but fails to teach the specifics of the memotherm stent’s structure.
Stoeckel teaches the structure of a memotherm stent is shown in Stoeckel, Figure 10.6 (e.g. see also first paragraph of section 10.3.2 bridging pages 243 and 245). The Examiner further notes Stoeckel’s structure has the same cell pattern as Lombardi’s Figures 5 and 7.
Stoeckel teaches a plurality of struts (e.g. Stoeckel, Figure 10.6), individual struts having a wall thickness (struts inherently have such a thickness; it is the radial thickness of the strut); and
a plurality of joints (e.g. Stoeckel, Figure 10.6, region where cells join; one in shown circled in Figure 10.6, see next limitation) configured to join alternating proximal and distal ends of adjacent struts of the plurality of struts (e.g. Stoeckel, Figure 10.6; the Examiner notes this limitation as disclosed by applicant is different than that claimed: Original Specification at [0059] “[t]he stent 200 includes a plurality of struts 210 joined by/at joints 220 at proximal and distal ends of the stent 200”; therefore, the two rows of cells at one end are considered to have the plurality of joints because they each also meet the disclosed requirement, where the joints are the bends/crowns).
Stoeckel and Lombardi are concerned with the same field of endeavor as the claimed invention, namely memotherm stents.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lombardi by incorporating the specific memotherm structure taught by Stoeckel as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143(I)) of the known (per Stoeckel) structure for the memotherm stent.
Regarding Claim 2, individual struts have a curved shape (e.g. Stoeckel, Figure 10.6).
Regarding Claim 3, adjacent struts are symmetric to each other (e.g. Stoeckel, Figure 10.6).
Regarding Claim 4, the wall thickness is configured so that the outward radial force is at least about 1 N (discussed supra for claim 1).
Regarding Claim 5, the wall thickness is configured to that the outward radial force is less than or equal to about 5 N (discussed supra for claim 1).
Regarding Claim 9, the compact diameter is less than or equal to about 2 mm (e.g. Lombardi, column 6, lines 22-40; the stent is compacted into a 10 French diameter, which is 3.3 mm; Applicant’s specification provides no bounds for “about”, therefore 3.3 mm is considered to be “about” 2 mm).
Regarding Claim 11, the stent operates to produce a radially outward force with a diameter of at least about 8 mm (e.g. Lombardi, column 6, lines 22-40; the expanded diameter is 10 mm; therefore as the stent expands with the forces discussed supra in claim 1, it passes through the 8 mm diameter and thus the stent has a radially outward force when the diameter is 8 mm).
Regarding Claim 12, the stent operates to produce a radially outward force with a diameter of at least about 14 mm (e.g. Lombardi, column 6, lines 22-40; the expanded diameter is 10 mm; Applicant’s specification provides no bounds for “about”, therefore 10 mm is considered to be “about” 14 mm).
Regarding Claim 13, individual struts form a repeating curved pattern (e.g. Stoeckel, Figure 10.6).
Regarding Claim 14, individual struts are joined to adjacent struts at nodes between proximal and distal joints (e.g. Stoeckel, Figure 10.6; at locations along the stent other than at the joints discussed supra for claim 1).
Regarding Claim 20, the outward radial force is at least about 1 N when the diameter of the radially self-expanding stent is less than or equal to about 2 mm (discussed supra for claims 1 and 9; the compact diameter discussed generally in claim 1 is that noted in claim 9, which is about 2 mm).
Regarding Claim 21, the outward radial force is at least about 5 N when the diameter of the radially self-expanding stent is less than or equal to about 20 mm (discussed supra for claims 1 and (9 or 11); the diameters discussed generally in claim 1 is that noted in either claim 9 or claim 11, which is about 2 mm or 8 mm, respectively, both of which are less than or equal to about 20 mm).
Claims 6-7 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over (Lombardi) (US 6,579,314 B1) in view of Stoeckel, as discussed supra, and further in view of Zando-Azizi, et al (Zando-Azizi) (US 5,907,893).
Regarding Claims 6-7 and 18, Lombardi discloses the invention substantially as claimed but fails to teach the wall thickness is at least 0.48 mm (claim 7) and thus also at least 0.33 mm (claim 6) and at least 0.32 mm (claim 18).
Zando-Azizi teaches stents having diamond shaped cells (e.g. Figures 6, 9) having struts having a thickness of 0.1 mm to 1.0 mm (e.g. column 3, line 58 to column 4, line 10).
Zando-Azizi and Lombardi are concerned with the same field of endeavor as the claimed invention, namely self-expanding stents having strut patterns.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lombardi such that the wall thickness is at least 0.48 mm (and thus also at least 0.33 mm and at least 0.32 mm) as taught by Zando-Azizi since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Claim 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrera, et al (Ferrera) (US 2011/0160763 A1) in view of Colgan, et al (Colgan) (US 6,264,689).
Regarding Claim 1, Ferrera teaches a radially self-expanding stent (e.g. [0008]) comprising:
a plurality of struts (e.g. Figures 8A-B, 26, 28; [0194]), individual struts having a wall thickness (struts inherently have such a thickness; it is the radial thickness of the strut); and
a plurality of joints (e.g. Figures 8A-B, 26, 28; region where cells join; the two rows of cells at one end are considered to have the plurality of joints because they each also meet the disclosed requirement, where the joints are the bends/crowns) configured to join alternating proximal and distal ends of adjacent struts of the plurality of struts (e.g. Figures 8A-B, 26, 28; the Examiner notes this limitation as disclosed by applicant is different than that claimed: Original Specification at [0059] “[t]he stent 200 includes a plurality of struts 210 joined by/at joints 220 at proximal and distal ends of the stent 200”; therefore, the two rows of cells at one end are considered to have the plurality of joints because they each also meet the disclosed requirement, where the joints are the bends/crowns),
wherein the stent is configured to produce an outward radial force (e.g. [0031]) with the stent having a diameter greater than or equal to a compact diameter and less than or equal to a fully expanded diameter (self-expanding stents transition from collapsed to fully expanded; any diameter between the compact diameter and up to the fully expanded diameter meets this requirement), the outward radial force depending at least in part on the wall thickness of individual struts (this limitation is inherently met because the amount of force needed to expand outward depends on the amount of material it is pushing outward and thus for stents includes the radial thickness) and configured to be sufficient to resist elastic recoil for aortic coarctation in a subject (e.g. [0031] disclose the force/mm and [0031], [0216] disclose the lengths of the scaffold; see Table I below for ranges where N is force in N calculated by (N/mm*mm length); the COF is the chronic outward force, which is the expansive force; Applicant’s original specification indicates at least expansion forces in the range of about 1N to about 5N are appropriate for the function of their invention; therefore, 0.54 N is considered “about” at least 1 N).
Table I: Ferrera
Lengths
at 5 mm
[0031]
at 50 mm
[0031]
at 60 mm
[0216]
N/mm
[0031]
N
N
N
0.00165
0.008
0.083
0.099
0.0025
0.013
0.125
0.150
0.0030
0.015
0.150
0.180
0.0059
0.030
0.295
0.354
0.0070
0.035
0.350
0.420
0.0090
0.045
0.450
0.540
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Ferrera such that the outward force is at least “about” 1 N as it has been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (MPEP 2144.05(I)).
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrera, et al (Ferrera) (US 2011/0160763 A1) in view of Colgan, et al (Colgan) (US 6,264,689).
Regarding Claim 8, Ferrera teaches a height of the stent varies from the compact diameter to the fully expanded diameter (e.g. Figures 8A-B, 26, 28; as the stent is made of rounded diamonds the stent inherently foreshortens when it expands).
Ferrera teaches the height of a cell in the axial direction (longer dimension of the diamond) is from 2 mm to 4 mm (e.g. [0018]).
Ferrera discloses the invention substantially as claimed but fails to teach the height is at least 14 mm at the fully expanded diameter and less than or equal to 20 mm at the compact diameter.
Colgan teaches a stent with diamond-shaped cells (e.g. abstract) having foreshortening upon expansion of 12-18% reduction (e.g. column 9, lines 20-25).
Colgan and Ferrera are concerned with the same field of endeavor as the claimed invention, namely self-expanding stents having diamond-shaped cells.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ferrera by incorporating the foreshortening range as taught by Colgan as it is a simple substitution of one known element (here, amount of foreshortening) for another to obtain predictable results (MPEP 2143(I)) of a stent that maintains a low delivery profile while also not having substantial foreshortening (e.g. Colgan, column 1, line 66 to column 2, line 11).
In the combination the 2 mm to 4 mm expanded cell size is the shortened size. Therefore, the compacted size is determined as follows: (expanded length) = (1-(%reduction/100))*(compacted length). For example: 4 mm = (1-(12%/100))*X, X = 4.55 mm.
As broadly claimed, the height claimed can be an height of the stent. Therefore, when the height is that of 4 cells, the compacted height of this region is 4*4.55 mm = 18.18 mm and the expanded height is 4*4 mm = 16 mm. For this height, the claimed values are met.
Relevant Prior Art
Tyagi, et al (Tyagi) (“Self- and balloon-expandable stent implantation for severe native coarctation of aorta in adults”, 2003, American Heart Journal, v146, no 5, pp 920-928) teaches treating aortic coarctation (e.g. abstract, Methods section) using a radially self-expanding stent in a crimped state (e.g. page 921, right-hand column, fourth paragraph), where the radially self-expanding stent produces a radially outward force that expands the narrowed vessel of a patient (e.g. abstract, Results section, Group B’s diameter increases when the stent is deployed).
Tyagi was provided in parent Application 16/686,673 on 10/28/2021.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 12/11/2025