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 .
Claim Objections
Claim 10 objected to because of the following informalities: Typographical error “around the tubular body adjacent the first open end, and a second anchor member extending circumferentially around the tubular body adjacent the second open end”. Following adjacent in both clauses should be the word “to”. Examiner suggests correcting to “around the tubular body adjacent to the first open end, and a second anchor member extending circumferentially around the tubular body adjacent to the second open end”. Appropriate correction is required.
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); 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1 and 16 (also dependent claims 2, 3, 5, 6, 7, 9, 10, 13, 14, 15 ) is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12064333, herein referred to as Pat 333’, in view of claims 1-2, and in further view of Lundkvist et al. US 20090177268 A1, herein referred to as Lundkvist.
Claim 2 of the issued patent discloses the limitations of claim 1 of the instant application, except the claim the claim limitation(s): “a uniform outer diameter along its entire body” and “extending radially outward beyond the outer diameter of the tubular body, wherein at least some of the plurality of spacer members are formed from a single wire defining a closed loop”.
However, Lundkvist discloses a stent (Fig 3, 8) comprising: a tubular body (20) formed of one or more interwoven wires ([0023]; see Figs 3-4), the tubular body defining a lumen ([0003]; Fig 5, center) and having first and second opposing open ends (22 and 24) and a length extending therebetween (distance between 22 and 24 shown in Figs 3-4), the tubular body having a uniform outer diameter along its entire length (Figs 3-4); and
the plurality of spacer members extending radially outward beyond the outer diameter of the tubular body (Figs 3-4) wherein at least some of the plurality of spacer members are formed from a single wire defining a closed loop (Figs 3-4).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the stent of Pat 333’ to incorporate “a uniform outer diameter along its entire body” and “extending radially outward beyond the outer diameter of the tubular body, wherein at least some of the plurality of spacer members are formed from a single wire defining a closed loop”, as taught and suggest by Lundkvist in order to allow a uniform diameter during stretching (Lundkvist [0026]).
Moreover, dependent claims 2, 3, 5, 6, 7, 9, 10, 13, 14, 15 of the instant application are substantially the same as the dependent claims of Pat 333’.
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.
Claim(s) 1-5, 8-9, 12, and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundkvist et al. US 20090177268 A1, herein referred to as Lundkvist, and in view of Leanne et al. 20140081382 A1, herein referred to as Leanne, and further in view Ryan et al. US 20130184833 A1, herein referred to as Ryan.
Regarding claim 1, Lundkvist discloses a stent (Fig 3, 8) comprising: a tubular body (20) formed of one or more interwoven wires ([0023]; see Figs 3-4), the tubular body defining a lumen ([0003]; Fig 5, center) and having first and second opposing open ends (22 and 24) and a length extending therebetween (distance between 22 and 24 shown in Figs 3-4), the tubular body having a uniform outer diameter along its entire length (Figs 3-4); and a plurality of spacer members (30a-d) disposed around the first open end and extending longitudinally away from and beyond the first open end of the tubular body (Figs 3-4),
the plurality of spacer members extending radially outward beyond the outer diameter of the tubular body (Figs 3-4).
Lundkvist does not explicitly disclose wherein at least some of the plurality of spacer members are formed from a single wire; and wherein a plurality of spacer members disposed around only the first open end and extending longitudinally away from and beyond the first open end of the tubular body; and wherein [the] wire having a region that is less flexible than the one or more interwoven wires forming the tubular body.
However, Leanne, in the same field of invention, discloses a stent (Fig 5, 16) comprising two ends (ends with 34/36 and 33 respectively) and a plurality of spacers (34/36). Leanne teaches wherein at least some of the plurality of spacer members are formed from a single wire (Fig 6, wire 60); and wherein a plurality of spacer members disposed around only the first open end and extending longitudinally away from and beyond the first open end of the tubular body (Fig 5).
Therefore, it would have been obvious to one of ordinary skill in the art prior the effective filling date of the claimed invention to connect the spacers as shown by Lundkvist in the primary embodiment by incorporating wherein at least some of the plurality of spacer members are formed from a single wire (wire separate from the interwoven body of the stent, joined using the struts of Leanne); and wherein a plurality of spacer members disposed around only the first open end and extending longitudinally away from and beyond the first open end of the tubular body, as taught and suggested by Leanne in order to allow the formation of slightly larger loops at the end of the stent (Leanne [0051]).
The combination of Lundkvist and Leanne do not disclose wherein [the] wire having a region that is less flexible than the one or more interwoven wires forming the tubular body.
However, Ryan in the same field of invention discloses a similar stent (Fig 2, 200). Ryan teaches wherein [the] wire (Figs 2a-c, 202) having a region that is less flexible (203b) than the one or more interwoven wires forming the tubular body (Fig 2, 202; Teaches wherein one set of wires is, tapered, thinner than another in the stent, imparting differing stiffness (i.e., flexibility) see para [0058]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the stent body wire thickness of Lundkvist to incorporate wherein [the] wire having a region that is less flexible than the one or more interwoven wires forming the tubular body, as taught and suggested by Ryan in order to provide a smaller stent profile (Ryan [0058]).
Regarding claim 2, the combination as made of Lundkvist, Ryan and Leanne, specifically Ryan teaches wherein each of the plurality of spacer members has a base region coupled to the tubular body (Annotated Fig 2C below) and an opposing free end region, wherein the free end region is more flexible than the base region (Annotated Fig 2C below; also see Fig 2 showing the free region, the thinner wire forms the opposing region).
Since Ryan teaches wherein each of the plurality of spacer members has a base region coupled to the tubular body and an opposing free end region, wherein the free end region is more flexible than the base region, which would be incorporated in the internal catheter when the modification was made.
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Regarding claim 3, the combination as made of Lundkvist, Ryan and Leanne, specifically Ryan teaches wherein each spacer member is formed from a wire having a first thickness in the base region and a second thickness in the free end region, wherein the second thickness is smaller than the first thickness (See annotated Fig 2c above).
Since Ryan teaches wherein each spacer member is formed from a wire having a first thickness in the base region and a second thickness in the free end region, wherein the second thickness is smaller than the first thickness, which would be incorporated in the internal catheter when the modification was made.
Regarding claim 4, Lundkvist discloses wherein each spacer member is formed from a single wire forming a closed loop (Figs 3-4).
Regarding claim 5, Lundkvist discloses wherein the one or more interwoven wires forming the tubular body also form at least some of the plurality of spacer members (Figs 3-4 teaches single wire construction [0003]).
Regarding claim 8, Lundkvist as modified by Leane and Ryan disclose wherein the plurality of spacer members is formed from wires separate from the tubular body and fixed to the tubular body. Leanne teaches wherein the plurality of spacer members (Figs 5-6; 34) is formed from wires separate from the tubular body and fixed to the tubular body (Figs 5-6; [0054]).
Since Leane teaches wherein the plurality of spacer members is formed from wires separate from the tubular body and fixed to the tubular body, which would be incorporated in the internal catheter when the modification was made.
Regarding claim 9, the combination as made of Lundkvist, Ryan and Leanne, specifically Ryan teaches wherein the plurality of spacer members is formed from wires that are less flexible than the wires forming the tubular body (Teaches wherein one set of wires is, tapered, thinner than another in the stent, imparting differing stiffness (i.e., flexibility) see para [0058]).
Since Ryan teaches wherein the plurality of spacer members is formed from wires that are less flexible than the wires forming the tubular body, which would be incorporated in the internal catheter when the modification was made.
Regarding claim 12, Lundkvist as modified by Ryan, and Leanne, specifically Leanne teaches wherein the plurality of spacer members are formed from separate wires from the tubular body and fixed to the tubular body (Fig 5), wherein the separate wires have first and second legs (54 and 56) fixed to a portion of the tubular body (46a/b) and extending toward the second open end (Fig 16).
Since Leanne teaches wherein the plurality of spacer members are formed from separate wires from the tubular body and fixed to the tubular body, wherein the separate wires have first and second legs fixed to a portion of the tubular body and extending toward the second open end, which would be incorporated in the internal catheter when the modification was made.
Regarding claim 14, Lundkvist discloses further comprising a covering extending over an entirety of the tubular body and the plurality of spacer members ([0006-0007]).
Regarding claim 15, Lundkvist discloses wherein when a pulling or squeezing force is applied to the plurality of spacer members, the outer diameter of the tubular body is not reduced ([0011]; Lundkvist teaches keeping a consistent diameter of the tubular body; The instant application recites using “nitinol, stainless steel, cobalt-based alloy such as platinum, gold, titanium, tantalum…; In para [0006], Lundkvist teaches using gold, platinum, tantalum. Therefore, having the material and structure of the instant application, Lundkvist inherently shares build characteristics of the instant application. As a result, Lundkvist is fully capable of “each of the plurality of spacer members is formed from a single wire forming a closed loop that has a base region fixed”).
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundkvist in view of Leanne.
Regarding claim 16, Lundkvist discloses a stent (Fig 3, 8) comprising: a tubular body (20) defining a lumen (Fig 5, center of stent shown) and having first and second opposing open ends (22 and 24) and a length extending therebetween (Figs 3-4), the tubular body having a uniform outer diameter along its entire length (Figs 3-4); and a plurality of spacer members (30a-d) disposed around only the first open end and extending longitudinally away from and beyond the first open end of the tubular body (Figs 3-4), the plurality of spacer members extending radially outward beyond the outer diameter of the tubular body (Figs 3-4), wherein each of the plurality of spacer members is formed from a single wire forming a closed loop that has a base region fixed (See annotated Fig 3 below) to the tubular body and an opposing free end region and the free end is more flexible than the base region (The instant application recites using “nitinol, stainless steel, cobalt-based alloy such as platinum, gold, titanium, tantalum…; In para [0006], Lundkvist teaches using gold, platinum, tantalum. Therefore, having the material and structure of the instant application, Lundkvist inherently shares build characteristics of the instant application. As a result, Lundkvist is fully capable of “each of the plurality of spacer members is formed from a single wire forming a closed loop that has a base region fixed”.).
Lundkvist does not disclose plurality of spacer members is formed from a single wire.
However, Leanne teaches wherein at least some of the plurality of spacer (Fig 6, 34) members are formed from a single wire (Fig 6).
Therefore, it would have been obvious to one of ordinary skill in the art prior the effective filling date of the claimed invention to modify the plurality of spacer members as shown by Lundkvist in the primary embodiment to incorporate wherein the plurality of spacer members are formed from a single wire [discrete wire] with a free end region that would be more flexible than a base region, as taught and suggested by Leanne in order to allow the formation of slightly larger loops at the end of the stent (Leanne [0051]).
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Annotated Fig 3 Lundkvist et al.
Regarding claim 17, Lundkvist discloses wherein the tubular body is formed from one or more interwoven wires (Fig 3-4), wherein the separate wires are fixed to an interior surface of the tubular body (Fig 3-4); but does not teach wherein the plurality of spacer members are formed from separate wires from the tubular body.
Leanne teaches wherein the plurality of spacer members (Figs 5-6; 34) are formed from wires separate from the tubular body and fixed to the tubular body (Figs 5-6; [0054]). Leanne teaches wherein the plurality of spacer members are formed from separate wires from the tubular body (Figs 5-6; 34).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the spacers of Lundkvist to incorporate wherein the plurality of spacer members are formed from separate wires from the tubular body, as taught and suggested by Leanne in order to allow the formation of slightly larger loops at the end of the stent (Leanne [0051]).
Regarding claim 18, the combination of Lundkvist as modified by Leanne, specifically Leanne, teaches wherein the separate wires have first and second legs fixed to a portion of the tubular body and extending toward the second open end (54 and 56).
Since, Leanne teaches wherein the separate wires have first and second legs fixed to a portion of the tubular body and extending toward the second open end, which would be incorporated in the anchoring element when the modification is made.
Claim(s) 6-7 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundkvist in view of Leanne and Ryan, and further in view of Hyodoh et al. US 8414635 B2, herein referred to as Hyodoh.
Regarding claim 6, Lundkvist as modified by Leanne and Ryan does not disclose herein the plurality of spacer members includes a first group having a first length and a second group having a second length, where the first length is longer than the second length.
Additionally, Hyodoh discloses a similar stent (Fig 33a, 700). Hyodoh further teaches wherein the plurality of spacer members includes a first group having a first length and a second group having a second length, where the first length is longer than the second length (Hyodoh Fig 33a, end have different length spacers, top and bottom).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the ends of Lundkvist to incorporate wherein the plurality of spacer members includes a first group having a first length and a second group having a second length, where the first length is longer than the second length, as taught and suggested by Hyodoh oh in order to match anatomical shapes as needed (Col 34, lines 31-40).
Regarding claim 7, Lundkvist as modified by Leanne, Ryan and Hyodoh, specifically Ryan teaches wherein the first group is more flexible than the second group (Fig 2, 202; Teaches wherein one set of wires is, tapered, thinner than another in the stent, imparting differing stiffness (i.e., flexibility) see para [0058]).
Since Ryan teaches wherein the first group is more flexible than the second group which would be incorporated in the anchoring element when the modification is made.
Regarding claim 13, the combination as made of Lundkvist, Ryan and Leanne does not explicitly disclose wherein the first and second legs extend along over 25% or more of the length of the tubular body.
However, Hyodoh teaches the first (5 plurality) and second legs (5 plurality) extend along over 25% or more of the length of the tubular body (Figs 51-53).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the spacers of the combination of Lundkvist, as modified Ryan and further modified by Leanne, to incorporate wherein the first and second legs extend along over 25% or more of the length of the tubular body, as taught and suggested by Hyodoh in order to accommodate an anatomical shaped cavity (Hyodoh Col 6, lines 10-21).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundkvist in view of Ryan and Leane, and further in view of Kim et al. 20120303132 A1, herein referred to as Kim.
Regarding claim 10, Lundkvist as modified by Ryan and Leanne does not disclose further comprising a first anchor member extending circumferentially around the tubular body adjacent the first open end, and a second anchor member extending circumferentially around the tubular body adjacent the second open end, the first and second anchor members each extending radially outward from the tubular body and each having an outer diameter larger than the outer diameter of the tubular body.
However, Kim discloses a stent (Fig 4, 100) comprising a tubular body (Fig 6, 110) and a first and second end (top and bottom ends). Kim teaches a first anchor member (120) extending circumferentially around the tubular body adjacent the first open end (Fig 6), and a second anchor member (120 is formed in a plurality) extending circumferentially around the tubular body adjacent the second open end (Fig 6), the first and second anchor members each extending radially outward from the tubular body and each having an outer diameter larger than the outer diameter of the tubular body (Fig 6).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the tubular body of Lundkvist to incorporate further comprising a first anchor member extending circumferentially around the tubular body adjacent the first open end, and a second anchor member extending circumferentially around the tubular body adjacent the second open end, the first and second anchor members each extending radially outward from the tubular body and each having an outer diameter larger than the outer diameter of the tubular body, as taught and suggested by Kim in order to allow anchoring with low friction (Kim [0040]).
Regarding claim 11, the combination of Lundkvist, Ryan, Leanne, and Kim, specifically Kim teaches wherein a portion of the tubular body extends beyond the first anchor member away from the second open end and defines the first open end (Fig 6).
Since Kim teaches wherein a portion of the tubular body extends beyond the first anchor member away from the second open end and defines the first open end, which would be incorporated in the anchoring element when the modification is made.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundkvist in view Leanne, and further in view of Kim.
Regarding claim 19, Lundkvist as modified by Leanne discloses the invention substantially as claimed and as discussed above with respect to claim 16, but does not disclose further comprising a first anchor member extending circumferentially around the tubular body adjacent the first open end, and a second anchor member extending circumferentially around the tubular body adjacent the second open end, the first and second anchor members each extending radially outward from the tubular body and each having an outer diameter larger than the outer diameter of the tubular body; wherein a portion of the tubular body extends beyond the first anchor member away from the second open end and defines the first open end.
However, Kim teaches a first anchor member (120) extending circumferentially around the tubular body adjacent the first open end (Fig 6), and a second anchor member (120 is formed in a plurality) extending circumferentially around the tubular body adjacent the second open end (Fig 6), the first and second anchor members each extending radially outward from the tubular body and each having an outer diameter larger than the outer diameter of the tubular body (Fig 6); wherein a portion of the tubular body extends beyond the first anchor member away from the second open end and defines the first open end (Fig 6).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the stent of Lundkvist to incorporate further comprising a first anchor member extending circumferentially around the tubular body adjacent the first open end, and a second anchor member extending circumferentially around the tubular body adjacent the second open end, the first and second anchor members each extending radially outward from the tubular body and each having an outer diameter larger than the outer diameter of the tubular body; wherein a portion of the tubular body extends beyond the first anchor member away from the second open end and defines the first open end., as taught and suggested by Kim in order to allow anchoring with low friction (Kim [0040]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundkvist in view of Ryan, and in further view of Kim.
Regarding claim 20, Lundkvist discloses a stent (Figs 3-4, 8) comprising: a tubular body (20) formed of one or more interwoven wires (Figs 3-4), the tubular body having first and second opposing open ends and a lumen extending therebetween, wherein the plurality of spacer (Figs 3-4, 30a-d) members are formed from one or more wires of the one or more interwoven wires forming the tubular body (teaches single wire construction [0003]), and a plurality of spacer members disposed around the first open end and extending longitudinally away from and beyond the first open end (Figs 3-4).
Lundkvist does not disclose a first anchor member disposed adjacent the first open end and a second anchor member disposed adjacent the second open end, the first and second anchor members each being formed from the one or more interwoven wires forming the tubular body and extending radially outward from the tubular body beyond an outer diameter of the tubular body and wherein a portion of one or more interwoven wires forming the plurality of spacer members has a first thickness adjacent the tubular body and the thickness tapers down to a second, smaller thickness in a terminal end region.
Kim teaches a first anchor member (120) disposed adjacent the first open end (Fig 6) and a second anchor member (120 is formed in a plurality) disposed adjacent the second open end (Fig 6), the first and second anchor members each being formed from the one or more interwoven wires forming the tubular body (Fig 4, 120).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the tubular body of Lundkvist to incorporate disclose a first anchor member disposed adjacent the first open end and a second anchor member disposed adjacent the second open end, the first and second anchor members each being formed from the one or more interwoven wires forming the tubular body and extending radially outward from the tubular body beyond an outer diameter of the tubular body, as taught and suggested by Kim in order to allow anchoring with low friction (Kim [0040]).
Yet, Lundkvist as modified by Kim does not explicitly disclose wherein a portion of one or more interwoven wires forming the plurality of spacer members has a first thickness adjacent the tubular body and the thickness tapers down to a second, smaller thickness in a terminal end region.
However, Ryan teaches wherein a portion of one or more interwoven wires (Figs 2a-c, 202) forming the plurality of spacer members (Fig 2, ends) has a first thickness adjacent to the tubular body and the thickness tapers down to a second (Annotated Fig 3 above), smaller thickness in a terminal end region (Annotated Fig 3 above).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the interwoven wires of Lundkvist to incorporate wherein a portion of one or more interwoven wires forming the plurality of spacer members has a first thickness adjacent the tubular body and the thickness tapers down to a second, smaller thickness in a terminal end region, as taught and suggested by Ryan in order to provide a smaller stent profile (Ryan [0058]).
Conclusion
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/A.F./Patent Examiner, Art Unit 3774
Matthew DeSanto
/MATTHEW F DESANTO/Primary Examiner, Art Unit 3700
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