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) 1-20 is/are pending.
Election/Restrictions
Applicant's election with traverse of Species 1-2 in the reply filed on 8/7/2026 is acknowledged. The traversal is on the ground(s) that see following. This is not found persuasive because see following.
Applicant argues claim 3 should be included in the elected species 1-2 because claim 3 does not use the language "side-by-side" and rather uses "there is no contact between any of the straight portions of each of the plurality of wires and any other straight portion of each of the plurality of wires" (Applicant's Response on 8/7/2026, herein "Response", page 6). The portions that overlap in e.g. Figure 7 are straight portions. There cannot be no contact with any two straight portion with each other and overlapping contact at the same time.
The Examiner notes that "no contact" indicates not only non-overlapping, but not touching. The only embodiments this language can represent is those with side-by-side elements as all embodiments are either overlapping or side-by-side (i.e. non-overlapping). Further, claims 3 requires "no contact" between any straight portions which cannot be met by an embodiment requiring overlapping (and thus contacting) wires. For these reasons, Applicant's argument is not persuasive.
Applicant's argue Figure 7 represents claim 3's language (Response, page 6). Looking at Figure 7, Examiner notes adjacent loops overlap and are thus do not meet the requirement of "no contact between any of the straight portions of each of the plurality of wires and any other straight portion of each of the plurality of wires". As seen in the Figures straight portions of adjacent loops overlap and thus contact each other.
Applicant's Figures provide for multiple loop options in the distal end regions. Annotated Figure A(1), A(2), and A(3) below shows the three options. Number labels added show different locations along the same wire for the same number.
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770
763
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Annotated Figure A(1), Instant Application
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778
762
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Annotated Figure A(2), Instant Application
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745
620
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Annotated Figure A(3), Instant Application
(straight segments are within the noted line regions)
With respect to these annotated Figures, both options 1 and 2 meet the requirements of independent claim 1. For claim 3 Applicant argues option 1, while for claim 14 Applicant argues option 2. Both cannot be the same set of features. Therefore, Examiner considers option 3 to be that claimed, which reads on all claims and is part of elected Species 1-2.
Therefore, the restriction/election with different structures at the distal end remains, where elected Species 1-2 includes claims 1-20.
The Examiner notes for purposes of this restriction, Examiner considers the side-by-side embodiment to be non-overlapping loops as in the noted example Figures.
The requirement is still deemed proper and is therefore made FINAL.
Allowable Subject Matter
Claim 15 is allowable over the prior art and would be allowable if the below rejections are addressed and if rewritten in independent form.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application will determine what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims see Table I below rejected on the ground of nonstatutory double patenting as being unpatentable over claims see Table I below of U.S. Patent No. see Table I below. Although the claims at issue are not identical, they are not patentably distinct from each other because the following prior claims contain the limitations claimed by the current Application as indicated in the following table.
Table I
Current Application
Prior Patent
US 11,998,463
Prior Patent
US 11,096,806
Prior Patent
US 10,130,499
Prior Patent
US 10,085,861
1
1, 3
1, 14, 19
1, 11, 17
1, 4, 6
2
1, 3
1, 14, 19
1, 11, 17
1, 4, 6
3
2
3, 14, 19
1, 11, 17
--
4
3
1, 14, 19
--
1, 4, 6
5
5
8, 17
1, 11, 17
1, 4, 6
6
8
10, 18
2
4
7
8
10, 18
2
4
8
9
12
2
5
9
4-8
1, 5, 10, 15, 18
1, 6, 12
1, 4, 6
10
4-8
1, 5, 10, 15, 18
1, 6, 12
1, 4, 6
11
13
--
--
1, 4, 6
12
13
--
--
1, 4, 6
13
3
1, 14, 19
--
1, 4, 6
14
1, 13
1, 14, 19
1, 11, 17
1, 4, 6
15
1, 13
3, 14, 19
1, 11, 17
--
16
4-8, 13-16, 18
1, 5, 10, 15, 18
1, 6, 12
1, 4, 6
17
8, 16
10, 18
2
4
18
3
1, 14, 19
--
1, 4, 6
19
3
1, 14, 19
1, 11, 17
1, 4, 6
20
3
1, 14, 19
1, 11, 17
1, 4, 6
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.
Claim(s) 1-7, 9-13, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Norton, et al (Norton) (US 2006/0116752 A1).
Regarding Claim 1, Norton teaches an endoluminal device (e.g. abstract) comprising:
a stent (e.g. Figure 3) having a proximal end region, a distal end region (e.g. Figure 3, distal is toward the right as shown and proximal is to the left as shown) and a longitudinal axis extending therebetween (this axis is inherently present and is left-right in the Figure as shown), the stent formed from a plurality of wires (e.g. abstract),
wherein each of the plurality of wires comprises a helical portion extending along a body of the stent (e.g. Figures 3, 33), a straight portion, and a bend located between the helical portion and the straight portion (e.g. annotated Figure 33(1) below; the circled bend shows that where the wires cross, there is a bend in each wire at the crossing point; there is such a wire along the shaded example loop that bridges between the helical path and the straight path before the terminal end bend); and
wherein the distal end region includes a plurality of loops formed by the plurality of wires (e.g. annotated Figure 33(1) below; one loop shaded), each loop being formed by the bend and the straight portion of a first wire of the plurality of wires, the bend and the straight portion of a second wire of the plurality of wires, and a joining region in which a terminal end of the first wire is joined to a terminal end of the second wire (e.g. annotated Figure 33(1) below); wherein each loop has only one joining region (e.g. annotated Figure 33(1) below).
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Annotated Figure 33(1), Norton
Regarding Claim 2, each loop overlaps or contacts at least a portion of a circumferentially adjacent loop (e.g. annotated Figure 33(1) above).
Regarding Claim 3, there is no contact between any of the straight portions of each of the plurality of wires and any other of the straight portions of each of the plurality of wires (e.g. annotated Figure 33(1) above; straight portions are separated by cross-over locations).
Regarding Claim 4, the joining region of each loop is proximal of a distal terminal end of the loop and distal of the at least one straight portion of each of the plurality of wires (e.g. annotated Figure 33(1) above).
Regarding Claim 5, the stent includes a medial region extending between the proximal end region and the distal end region (e.g. annotated Figure 3 below), wherein the plurality of wires defines a braid pattern in the medial region (e.g. annotated Figure 3 below).
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696
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Annotated Figure 3(1), Norton
Regarding Claim 6, the braid pattern in the medial region defines a first set of braid angles, and wherein a braid pattern of the plurality of wires in the distal end region defines a second set of braid angles, the second set of braid angles different than the first set of braid angles (e.g. annotated Figure 3(1) above; where the angle of the distal end is the most distal angle).
Regarding Claim 7, the braid pattern in the medial region includes the plurality of wires interwoven at a medial braid angle, wherein the distal end region includes the plurality of wires crossing one another at a distal braid angle less than the medial braid angle (e.g. annotated Figure 3(2) below).
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Annotated Figure 3(2), Norton
Regarding Claim 9, the first wire of the plurality of wires extends from the braid pattern and across a cross-over point in a first helical direction, the cross-over point defined by the intersection of the first wire and the second wire of the plurality of wires (e.g. annotated Figure 33(1) above; the cross-over point of the first and second wires is considered to be the first point where they contact each other just before the joining region on the side toward the medial region).
Regarding Claim 10, the second wire of the plurality of wires extends from the braid pattern and across the cross-over point in a second helical direction opposite the first helical direction (e.g. annotated Figure 33(1); the directions are opposite one another and thus different).
Regarding Claim 11, after the cross-over point the first wire transitions into the straight portion of the first wire and then into the bend of the first wire (e.g. annotated Figure 33(1) above; following the first wire (left wire as shown) from the joining region to the terminal end bend to a straight portion, to the bend).
Regarding Claim 12, after the cross-over point the second wire transitions into the straight portion of the second wire and then into the bend of the second wire (e.g. annotated Figure 33(1) above; following the second wire (right wire as shown) from the joining region to a straight region to the bend).
Regarding Claim 13, the joining region of each loop includes only the terminal ends of the first and second wires (e.g. [0049]).
Regarding Claim 19, Norton teaches an endoluminal device (e.g. abstract) comprising:
a stent (e.g. Figure 3) having a proximal end region, a medial region, a distal end region (e.g. annotated Figure 3(1) above), and a longitudinal axis extending between the proximal and distal end regions (this axis is inherently present and is left-right in the Figure as shown), the stent formed from a plurality of wires (e.g. abstract);
wherein the distal end region includes a plurality of loops formed by the plurality of wires (e.g. annotated Figure 33(1) above; one loop shaded), each loop overlapping only two circumferentially adjacent loops (e.g. annotated Figure 33(1) above), each loop defined by a proximal cross-over point of a first wire and a second wire (e.g. annotated Figure 33(1) above; the cross-over point of the first and second wires is considered to be the first point where they contact each other just before the joining region on the side toward the medial region), straight side portions of the first and second wires (e.g. annotated Figure 33(1) above), and a joining region joining terminal end regions of only the first and second wires (e.g. annotated Figure 33(1) above, [0049]).
Claim(s) 14 and 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Minasian, et al (Minasian) (US 2003/0220683 A1).
Regarding Claim 14, Norton teaches an endoluminal device (e.g. abstract) comprising:
a stent (e.g. Figure 5a) having a proximal end region, a medial region, a distal end region (e.g. annotated Figure 5a(2) below), and a longitudinal axis extending between the proximal and distal end regions (this axis is inherently present and is left-right in the Figure as shown), the stent formed from a plurality of wires (e.g. [0043], Figure 5a);
wherein the distal end region includes a plurality of loops formed by the plurality of wires (e.g. annotated Figure 5a(1) below; one loop shaded), each loop overlapping only two circumferentially adjacent loops (e.g. annotated Figure 5a(1) below), each loop defined by a proximal cross-over point of a first wire and a second wire of the plurality of wires (e.g. annotated Figure 5a(1) below), straight side portions defined by the first and second wires (e.g. annotated Figure 5a(1) below), a distal end apex defined by the first wire (e.g. annotated Figure 5a(1) below), and a joining region joining terminal end regions of the first and second wires (e.g. annotated Figure 5a(1) below; the noted joining region is considered where one wire ends and the other begins and thus represents terminal end regions of the two wires); and
wherein the straight side portions defined by the first and second wires extend substantially parallel to the longitudinal axis (e.g. annotated Figure 5a(1) below).
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614
721
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Annotated Figure 5a(1), Minasian
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515
596
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Annotated Figure 5a(2), Minasian
Regarding Claim 16, at the proximal cross-over point, the first wire extends in a first helical direction and the second wire extends in a second helical direction opposite to the first helical direction (e.g. annotated Figure 5a(1) above).
Regarding Claim 17, the medial region includes a braid pattern including the plurality of wires interwoven at a medial braid angle, wherein the distal end region includes the plurality of wires crossing one another at a distal braid angle less than the medial braid angle (e.g. annotated Figure 5a(2) above, each crossing forms two angles, a larger and a smaller angle; in the portion of the distal end with the same angle pair as the medial region the smaller angle here is less than the larger of the two angles in the medial region).
Regarding Claim 18, each joining region includes only the terminal end regions of the first and second wires (discussed supra for claim 14).
Regarding Claim 19, Norton teaches an endoluminal device (e.g. abstract) comprising:
a stent (e.g. Figure 5a) having a proximal end region, a medial region, a distal end region (e.g. annotated Figure 5a(1) above), and a longitudinal axis extending between the proximal and distal end regions (this axis is inherently present and is left-right in the Figure as shown), the stent formed from a plurality of wires (e.g. [0043], Figure 5a);
wherein the distal end region includes a plurality of loops formed by the plurality of wires (e.g. annotated Figure 5a(1) above; one loop shaded), each loop overlapping only two circumferentially adjacent loops (e.g. annotated Figure 5a(1) above), each loop defined by a proximal cross-over point of a first wire and a second wire (e.g. annotated Figure 5a(1) above), straight side portions of the first and second wires (e.g. annotated Figure 5a(1) above), and a joining region joining terminal end regions of only the first and second wires (e.g. annotated Figure 5a(1) below; the noted joining region is considered where one wire ends and the other begins and thus represents terminal end regions of the two wires).
Regarding Claim 20, the straight side portions of the first and second wires extend substantially parallel to the longitudinal axis (e.g. annotated Figure 5a(1) above).
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.
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Norton, et al (Norton) (US 2006/0116752 A1) as discussed supra and further in view of Gill, et al (Gill) (US 2014/0277573 A1).
Regarding Claim 8, Norton discloses the invention substantially as claimed but fails to teach the medial braid angle is between 95 degrees and 115 degrees.
Gill teaches a braided stent having a braid angle between 95 degrees and 115 degrees (e.g. [0046], 90 degrees).
Gill and Norton are concerned with the same field of endeavor as the claimed invention, namely braided 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 Norton such that the braid angle is between 95 degrees and 115 degrees as taught by Gill in order to a specific stiffness to the device achieved with the given braid angle (here 90 degrees) (e.g. Gill, [0046]). Further, 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).
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 9/3/2026