DETAILED ACTION
Claims 5-7, 9-16, and 18-19 are canceled. Claims 21-33 are newly added claims. A complete action on the merits of pending claims 1-4, 8, 17, and 20-33 appears below.
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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-4, 8, 17, and 20-33 in the reply filed on 01/06/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 01/03/2024, 04/11/2025, and 03/17/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1 and 17 are objected to because of the following informalities:
In claims 1 and 17, the comma in “; and,” should be canceled/removed.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Such claim limitation(s) is/are: “coil means for occluding a vessel”, “stretch resistant means for resisting stretching or unwinding of the coil means”, and “stopper means for preventing the stretch resistant means from withdrawing into the radiopaque marker band” in claim 20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“coil means for occluding a vessel” – the corresponding structure disclosed in the specification (the embolic coil formed from wound wire (101), as described in Paragraph [0057] and Figures 1B-1C).
“stretch resistant means for resisting stretching or unwinding of the coil means” – the corresponding structure disclosed in the specification (the stretch resistant member (105)/tether (105A), including one-piece or two-piece configurations with filament, braid, or eyelet, as described in Paragraphs [0003], [0007], [0060]-[0061], and Figures 1C-8B).
“stopper means for preventing the stretch resistant means from withdrawing into the radiopaque marker band” – the corresponding structure disclosed in the specification (the enlargement/stopper (107), such as a knot formed from the tether, optionally with adhesive, as described in Paragraphs [0005], [0064]-[0068], and Figures 1C-1D) and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 22 is 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 22 recites, “wherein the enlargement is freely movable within the tubular member.” However, the specification consistently describes the enlargement (e.g., knot or stopper (107)) as being located and freely movable within the interior (100A) of the embolic coil (see Paragraphs [0045]-[0046], Figures 1C-1D and 2C) and explicitly states that the enlargement is prevented from entering the interior lumen of the tubular member (109) because its width or diameter is greater than the lumen of the tubular member (see Paragraphs [0005], [0042]-[0043], & Figure 1D).
Under the broadest reasonable interpretation consistent with the specification (MPEP 2111, 2173.01), claim 22 is therefore understood to mean that the enlargement is freely movable within the interior of the coiled wire and is configured so that it cannot enter the tubular member (i.e., it abuts/stops against the distal end of the tubular member). Because the literal claim language (“within the tubular member”) directly conflicts with the specification’s clear teaching that the enlargement cannot enter the tubular member, the metes and bounds of the claim are unclear. One of ordinary skill in the art would not know with reasonable certainty whether the claim covers (1) the invention actually disclosed (enlargement movable inside the coil and stopped at the tubular member) or (2) a different configuration in which the enlargement actually moves inside the tubular member’s lumen. This inconsistency renders the scope of claim 22 indefinite.
For examination and prior-art purposes, the limitation of claim 22 will be interpreted under the broadest reasonable interpretation consistent with the specification as: “wherein the enlargement is freely movable within the coiled wire.” This interpretation makes claim 22 substantively identical to claim 4.
Applicant is required to clarify or amend claim 22 to resolve the indefiniteness issue.
Claim Rejections - 35 USC § 103
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 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) 1-4, 8, 17, and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Purdy (US 5,263,964 A), in view of Jones (US 2008/0086163 A1 (and Jones2 (US 2008/0086217 A10), incorporated by reference therein)).
Regarding claim 1, Purdy discloses, a vaso-occlusive coil coaxial traction detachment apparatus. Purdy teaches, an embolic coil device (Figure 1, device (10); Col. 4, line 66-68), comprising:
a coiled wire (Figure 1, endovascular device (18); Col. 4, line 68-Col. 5, line 5) including a distal end (See annotated Figure 1 below, (Distal end)), a proximal end (See annotated Figure 1 below, (Proximal end)), and an interior (See annotated Figure 1 below, (Interior));
a tubular member (Figures 1-2, sheath (14); Col. 4, line 68-Col. 5, line 6) attached at or near the proximal end (Proximal end) of the coiled wire (Col. 5, line 12-13; Further as seen in Figures 1-2, sheath (14) is indeed attached near the (Proximal end) of endovascular device (18)), the tubular member (sheath (14)) including an interior lumen (See annotated Figure 1 below, (Interior lumen));
a tether (Figures 1-2, guide wire (16)) extending through the interior of the tubular member (Figures 1-2; Col. 4, line 68-Col. 5, line 6), wherein the tether comprises an enlargement (Figures 1-2, attachment point (20); Col. 5, line 2-4 and line 13-16); and
wherein the enlargement (attachment point (20)) is comprised of a greater width or diameter than the interior lumen (Interior lumen) of the tubular member (sheath (14)) (Col. 5, line 13-16, “The point of attachment 20 is of a diameter such that when traction is placed on the guide wire 16, the attachment cannot enter the sheath 14.”).
Purdy fails to teach, the tether connected with the distal end of the coiled wire and extending through the interior of the coiled wire.
Jones discloses, embolic coils. Jones teaches, a coiled wire (Figure 1, wound coil (12a)) including a distal end (Figure 1, distal coil portion (20)), a proximal end (Figure 1, proximal coil portion (18)), and an interior (Figure 1, central lumen (16)) (Paragraph [0016]);
a tubular member (Figure 1, hypotube (21)/headpiece (22)) attached at or near the proximal end (proximal coil portion (18)) of the coiled wire (wound coil (12a)) (Paragraphs [0016]-[0017]), the tubular member (hypotube (21)/headpiece (22)) including an interior lumen (Figure 1, clearly shows hypotube (21) as possessing an interior lumen); and
a tether (Jones is a continuation-in-part of application Ser. No. 11/539,937 (Jones 2 (US 2008/0086217 A1)), filed Oct. 10, 2006, which is incorporated by reference into Jones; Jones2 discloses in Figure 4, stretch resistant member (26b); Paragraph [0032] of Jones2) connected with the distal end of the coiled wire and extending through the interior of the coiled wire (Figure 2 and Paragraph [0032] of Jones2), wherein the tether (stretch resistant member (26b)) comprises an enlargement (Figure 4 of Jones2, enlarged portion (28a); Paragraph [0032] of Jones2).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the embolic coil device of Purdy with the embolic coil of Jones/Jones2 such that the tether is connected with the distal end of the coiled wire and is extending through the interior of the coiled wire as taught by Jones/Jones2, as both references and the claimed invention are directed to endovascular embolic coil devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embolic coil device of Purdy with the embolic coil of Jones/Jones2 such that the tether is connected with the distal end of the coiled wire and is extending through the interior of the coiled wire as taught by Jones/Jones2, as such a modification would have been predictable, namely, to convert Purdy’s temporary detachment tether into a permanent stretch-resistant member that remains inside the deployed coil after detachment, thereby preventing unwanted stretching or unwinding of the coiled wire during delivery or repositioning while still utilizing Purdy’s enlargement-to-tubular-lumen stop mechanism at the proximal end. Furthermore, a person of ordinary skill in the art would have been motivated to make this modification because Jones explicitly teaches that adding a distally-anchored stretch-resistant tether extending through the coil interior provides improved resistance to stretching/unwinding (see Jones2, Paragraphs [0019]-[0022] and [0032]), which is a known problem in soft embolic coils, and applying this known improvement to Purdy’s coil (which already has a proximal tubular member and enlargement-based stop) would yield the predictable benefit of a more robust, stretch-resistant implant without compromising the traction detachment function. This combination results in the tether being connected at the distal end, extending through both the coil interior and the proximal tubular member, with the enlargement sized greater than the tubular member’s interior lumen, as required by the claim (KSR v. Teleflex; MPEP 2143(A), (C) – combining known elements according to known methods to yield predictable results and applying a known technique to a known device for improvement).
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Regarding claim 2, modified Purdy teaches, wherein the enlargement is not directly connected to the coiled wire (Purdy discloses the enlargement (attachment point (20)) is not directly connected to the coiled wire in the sense that it functions as an interface between the tether (guide wire (16)) and the coil rather than being fused or tied into the coil wire itself; Col. 5, line 2-4 and line 13-16) and wherein at least a portion of the tether is stretch-resistant (Jones2 further discloses that the tether (stretch resistant member (26b)) is stretch-resistant (Paragraphs [0019]-[0022] and [0032]; the member is formed of substantially non-ductile material such as PET or metallic alloys to bear axial load and resist stretching/unwinding of the coil) (It would have been obvious to one of ordinary skill in the art to incorporate Jones2’s stretch-resistant tether material into the modified device of Purdy for the reasons stated in the rejection of claim 1 (predictable improvement in stretch resistance without compromising Purdy’s enlargement-to-tubular-lumen stop)).
Regarding claim 3, modified Purdy teaches, wherein the enlargement is positioned entirely within the interior of the coiled wire (Jones2 discloses the enlargement (proximal enlarged portion (28a)) is positioned entirely within the interior of the coiled wire (Figure 4; Paragraph [0032]; the enlargement engages the internal restrictor or remains inside the coil lumen)) (It would have been obvious to one of ordinary skill in the art to position the enlargement entirely within the coil interior in the modified Purdy device for the reasons stated in the rejection of claim 1 (to maintain centering and utilize the proximal tubular member stop while keeping all components internal to the implant)).
Regarding claim 4, modified Purdy teaches, wherein the enlargement is freely movable within the interior of the coiled wire (Jones2 discloses the enlargement (proximal enlarged portion (28a)) is freely movable within the interior of the coiled wire (Figure 4 and Paragraphs [0023]-[0026] and [0032]; the stretch resistant member is free-floating until the enlargement engages the restrictor under tension, allowing axial movement inside the lumen)) (It would have been obvious to one of ordinary skill in the art to make the enlargement freely movable in the modified Purdy device for the reasons stated in the rejection of claim 1 (predictable result of allowing normal coil flexibility/softness while providing stretch resistance via the proximal stop)).
Regarding claim 8, modified Purdy teaches, wherein the tether is positioned along a central longitudinal axis of the interior of the coiled wire so as to provide on-axis torque (Jones2 discloses the tether (stretch resistant member (26b)) is positioned along a central longitudinal axis of the interior of the coiled wire so as to provide on-axis torque (Jones2, Paragraphs [0020]-[0022], [0032]; centrally placed stretch resistant member with proximal enlargement avoids off-axis forces and ensures more uniform torque transmission between the pusher and the coil)) (It would have been obvious to one of ordinary skill in the art to position the tether along the central longitudinal axis in the modified Purdy device, as taught by Jones2, for the reasons stated in the rejection of claim 1 (to eliminate off-axis torque and improve predictable delivery behavior, a known benefit in centrally anchored stretch-resistant designs)).
Regarding claim 22, as best understood in view of the 112(b) rejection above, modified Purdy teaches, wherein the enlargement is freely movable within the coiled wire (Jones2 discloses the enlargement (proximal enlarged portion (28a)) is freely movable within the interior of the coiled wire (Figure 4 and Paragraphs [0023]-[0026] and [0032]; the stretch resistant member is free-floating until the enlargement engages the restrictor under tension, allowing axial movement inside the lumen)) (It would have been obvious to one of ordinary skill in the art to make the enlargement freely movable in the modified Purdy device for the reasons stated in the rejection of claim 1 (predictable result of allowing normal coil flexibility/softness while providing stretch resistance via the proximal stop)).
Regarding claim 23, modified Purdy teaches, wherein the tubular member is comprised of a hypotube (Jones, Paragraphs [0016]-[0017]; hypotube (21) is explicitly used to form the headpiece at the proximal end of the coil) (It would have been obvious to use a hypotube for the tubular member in the modified Purdy device for the reasons given in claim 1 (hypotubes are a known, conventional proximal attachment structure in embolic coils for secure pusher interface and controlled detachment)).
Regarding claim 24, Purdy further teaches, wherein a distal end of the tubular member (Figure 2, distal end (14a) of the sheath (14)) is adjacent to the proximal end (Proximal end) of the coiled wire (endovascular device (18)) (Col. 4, line 68-Col. 5, line 4 and Col. 5, line 12-13; Figures 1-2).
Regarding claim 25, modified Purdy teaches, wherein at least a proximal-most coil of the coiled wire is attached to an outer circumference of the tubular member (Jones discloses at least a proximal-most coil of the coiled wire is attached to an outer circumference of the tubular member (Paragraph [0017] of Jones and Figure 1)) (It would have been obvious to attach the proximal-most coil to the outer circumference of the tubular member in the modified Purdy device for the reasons given in claim 1 (to create a reliable mechanical connection between the coil and the proximal tubular member using conventional attachment techniques)).
Regarding claim 17, Purdy teaches, a system for delivering an embolic coil to a target location (Figure 1, device (10); Col. 1, line 6-12 and Col. 4, line 66-68), comprising:
a delivery catheter (Figures 1-2, catheter (12); Col. 5, line 5-11);
a coiled wire (Figure 1, endovascular device (18); Col. 4, line 68-Col. 5, line 5) having a distal end (See annotated Figure 1 above, (Distal end)), a proximal end (See annotated Figure 1 above, (Proximal end)), and an interior (See annotated Figure 1 above, (Interior));
a tubular member (Figures 1-2, sheath (14); Col. 4, line 68-Col. 5, line 6) attached to the proximal end (Proximal end) of the coiled wire (Col. 5, line 12-13; Further as seen in Figure 2, sheath (14) is indeed attached to the (Proximal end) of endovascular device (18) through attachment point (20)), the tubular member (sheath (14)) including an interior lumen (See annotated Figure 1 above, (Interior lumen)) having an inner diameter which is smaller than an inner diameter of the interior (Interior) of the coiled wire (endovascular device (18)) (As seen in Figures 1-2 and disclosed in Col. 5, line 35-37, when endovascular device (18) is in the uncompressed state (outside sheath (14)) it has a grater diameter than sheath (14));
a tether (Figures 1-2, guide wire (16)) extending through the delivery catheter and the tubular member (Figures 1-2; Col. 4, line 68-Col. 5, line 11); and
wherein the tether (guide wire (16)) includes an enlargement (Figures 1-2, attachment point (20); Col. 5, line 2-4 and line 13-16) having a diameter or width greater than the inner diameter of the interior lumen (Interior lumen) of the tubular member (sheath (14)) (Col. 5, line 13-16, “The point of attachment 20 is of a diameter such that when traction is placed on the guide wire 16, the attachment cannot enter the sheath 14.”).
Purdy fails to teach, wherein a distal end of the tether is connected with the distal end of the coiled wire.
Jones teaches, a coiled wire (Figure 1, wound coil (12a)) including a distal end (Figure 1, distal coil portion (20)), a proximal end (Figure 1, proximal coil portion (18)), and an interior (Figure 1, central lumen (16)) (Paragraph [0016]);
a tubular member (Figure 1, hypotube (21)/headpiece (22)) attached at or near the proximal end (proximal coil portion (18)) of the coiled wire (wound coil (12a)) (Paragraphs [0016]-[0017]), the tubular member (hypotube (21)/headpiece (22)) including an interior lumen (Figure 1, clearly shows hypotube (21) as possessing an interior lumen); and
a tether (Jones is a continuation-in-part of application Ser. No. 11/539,937 (Jones 2 (US 2008/0086217 A1)), filed Oct. 10, 2006, which is incorporated by reference into Jones; Jones2 discloses in Figure 4, stretch resistant member (26b); Paragraph [0032] of Jones2), wherein a distal end of the tether is connected with the distal end of the coiled wire (Figure 2 and Paragraph [0032] of Jones2), wherein the tether (stretch resistant member (26b)) comprises an enlargement (Figure 4 of Jones2, enlarged portion (28a); Paragraph [0032] of Jones2).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the embolic coil device of Purdy with the embolic coil of Jones/Jones2 such that the distal end of the tether is connected with the distal end of the coiled wire as taught by Jones/Jones2, as both references and the claimed invention are directed to endovascular embolic coil devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embolic coil device of Purdy with the embolic coil of Jones/Jones2 such that the distal end of the tether is connected with the distal end of the coiled wire as taught by Jones/Jones2, as such a modification would have been predictable, namely, to convert Purdy’s temporary detachment tether into a permanent stretch-resistant member that remains inside the deployed coil after detachment, thereby preventing unwanted stretching or unwinding of the coiled wire during delivery or repositioning while still utilizing Purdy’s enlargement-to-tubular-lumen stop mechanism at the proximal end. Furthermore, a person of ordinary skill in the art would have been motivated to make this modification because Jones explicitly teaches that adding a distally-anchored stretch-resistant tether extending through the coil interior provides improved resistance to stretching/unwinding (see Jones2, Paragraphs [0019]-[0022] and [0032]), which is a known problem in soft embolic coils, and applying this known improvement to Purdy’s coil (which already has a proximal tubular member and enlargement-based stop) would yield the predictable benefit of a more robust, stretch-resistant implant without compromising the traction detachment function. This combination results in the distal end of the tether being connected to the distal end of the coil, with the enlargement sized greater than the tubular member’s interior lumen, as required by the claim (KSR v. Teleflex; MPEP 2143(A), (C) – combining known elements according to known methods to yield predictable results and applying a known technique to a known device for improvement).
Claim(s) 21 and 26-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Purdy, in view of Jones/Jones2, and further in view of Fitz (US 2006/0052815 A1).
Regarding claim 21, Purdy teaches, the tubular member (sheath (14)).
Purdy fails to teach, wherein the tubular member is radiopaque.
Jones teaches, aspects of the embolic coil device according to claim 1 (See above rejection of claim 1).
Fitz discloses, an embolic coil/implant delivery system. Fitz teaches, a tubular member (Figure 7, delivery pusher (350)) is radiopaque (Paragraph [0061]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the embolic coil device of Purdy to make the tubular member radiopaque as taught by Fitz, as all the references and the claimed invention are directed to endovascular embolic coil devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embolic coil device of Purdy to make the tubular member radiopaque as taught by Fitz, as such a modification would have been predictable, namely, to allow real-time visualization of the proximal end of the implant/the position of the tubular member under fluoroscopy (Paragraph [0061] of Fitz).
Regarding claim 26, Purdy teaches, the enlargement (attachment point (20)).
Purdy fails to teach, wherein the enlargement is comprised of a knot.
Jones teaches, aspects of the embolic coil device according to claim 1 (See above rejection of claim 1).
Fitz teaches, a tether (Figure 4, tether (310)) comprising an enlargement (Figure 4, knot (316)), wherein the enlargement is comprised of a knot (knot (316) is explicitly used to tie tether (310) around the proximal end of the implant device (302) as seen in Figure 4) (Paragraph [0053]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the embolic coil device of Purdy to form the enlargement as a knot as taught by Fitz, as all the references and the claimed invention are directed to endovascular embolic coil devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embolic coil device of Purdy to form the enlargement as a knot as taught by Fitz, as such a modification would have been predictable, namely, a knot is a simple, predictable, and commonly used way to create a reliable enlargement on a filamentary tether that cannot pass through the tubular lumen (Paragraphs [0007] and [0053] of Fitz).
Regarding claim 27, modified Purdy teaches, wherein the knot includes an adhesive (Figure 4 and Paragraph [0053] of Fitz disclose, “Further reinforcement is provided by an adhesive 314 that is disposed around the knot 316.” It would have been obvious to one of ordinary skill in the art to include adhesive with the knot in the modified Purdy device to prevent untying or otherwise unwanted decoupling (Paragraph [0053] of Fitz)).
Regarding claim 28, modified Purdy teaches, wherein the knot is formed from the tether (Paragraph [0053] of Fitz explicitly discloses that knot (316) is formed of tether (310) tying around proximal end of the implant device (302). It would have been obvious to one of ordinary skill in the art to form the knot from the tether material in the modified Purdy device for the reasons given in claim 26 (a self-knot in the tether is a simple and predictable method to create the required enlargement using only the existing tether filament)).
Regarding claim 29, Purdy teaches, the tubular member (sheath (14)).
Purdy fails to teach, wherein the tubular member is comprised of a radiopaque hypotube.
Jones teaches, the tubular member is comprised of a hypotube (Paragraphs [0016]-[0017]; hypotube (21) is explicitly used to form the headpiece at the proximal end of the coil).
Fitz teaches, a tubular member (Figure 7, delivery pusher (350)) is radiopaque (Paragraph [0061]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the embolic coil device of Purdy to use a hypotube for the tubular member as taught by Jones, and to make the tubular member/hypotube radiopaque as taught by Fitz, as all the references and the claimed invention are directed to endovascular embolic coil devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embolic coil device of Purdy to use a hypotube for the tubular member as taught by Jones, and to make the tubular member/hypotube radiopaque as taught by Fitz, as such a modification would have been predictable, namely, to allow real-time visualization of the proximal end of the implant/the position of the tubular member under fluoroscopy (Paragraph [0061] of Fitz). Furthermore, hypotubes are a known, conventional proximal attachment structure in embolic coils for secure pusher interface and controlled detachment.
Regarding claim 30, Purdy teaches, the enlargement (attachment point (20)).
Purdy fails to teach, wherein the enlargement is comprised of a knot.
Jones teaches, aspects of the embolic coil device according to claim 17 (See above rejection of claim 17)
Fitz teaches, a tether (Figure 4, tether (310)) comprising an enlargement (Figure 4, knot (316)), wherein the enlargement is comprised of a knot (knot (316) is explicitly used to tie tether (310) around the proximal end of the implant device (302) as seen in Figure 4) (Paragraph [0053]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the embolic coil device of Purdy to form the enlargement as a knot as taught by Fitz, as all the references and the claimed invention are directed to endovascular embolic coil devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embolic coil device of Purdy to form the enlargement as a knot as taught by Fitz, as such a modification would have been predictable, namely, a knot is a simple, predictable, and commonly used way to create a reliable enlargement on a filamentary tether that cannot pass through the tubular lumen (Paragraphs [0007] and [0053] of Fitz).
Claim(s) 20 and 31-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Purdy, in view of Fitz, and further in view of Jones/Jones2.
Regarding claim 20, Purdy teaches, an embolic coil device (Figure 1, device (10); Col. 4, line 66-68), comprising:
a coil means (Figure 1, endovascular device (18); Col. 4, line 68-Col. 5, line 5) for occluding a vessel (Col. 1, line 6-12), the coil means including a distal end (See annotated Figure 1 above, (Distal end)), a proximal end (See annotated Figure 1 above, (Proximal end)), and an interior (See annotated Figure 1 above, (Interior));
a band (Figures 1-2, sheath (14); Col. 4, line 68-Col. 5, line 6) attached at or near the proximal end (Proximal end) of the coil means (Col. 5, line 12-13; Further as seen in Figures 1-2, sheath (14) is indeed attached near the (Proximal end) of endovascular device (18)), the band (sheath (14)) including an interior lumen (See annotated Figure 1 above, (Interior lumen)); and
a stretch resistant means (Figures 1-2, guide wire (16)) extending through the band (Figures 1-2; Col. 4, line 68-Col. 5, line 6), wherein the stretch resistant means comprises a stopper means (Figures 1-2, attachment point (20); Col. 5, line 2-4 and line 13-16) for preventing the stretch resistant means (guide wire (16)) from withdrawing into the band (sheath (14)) (Col. 5, line 13-16, “The point of attachment 20 is of a diameter such that when traction is placed on the guide wire 16, the attachment cannot enter the sheath 14.” This effectively prevents at least part of guide wire (16) from withdrawing into sheath (14)).
Purdy fails to teach the band as a radiopaque marker band; and the stretch resistant means for resisting stretching or unwinding of the coil means extending through the interior of the coil means.
Fitz teaches, a radiopaque marker band (Figure 7, delivery pusher (350); Paragraph [0061]).
Jones teaches, a coil means (Figure 1, wound coil (12a)) including a distal end (Figure 1, distal coil portion (20)), a proximal end (Figure 1, proximal coil portion (18)), and an interior (Figure 1, central lumen (16)) (Paragraph [0016]);
a band (Figure 1, hypotube (21)/headpiece (22)) attached at or near the proximal end (proximal coil portion (18)) of the coil means (wound coil (12a)) (Paragraphs [0016]-[0017]), the band (hypotube (21)/headpiece (22)) including an interior lumen (Figure 1, clearly shows hypotube (21) as possessing an interior lumen); and
a stretch resistant means (Jones is a continuation-in-part of application Ser. No. 11/539,937 (Jones 2 (US 2008/0086217 A1)), filed Oct. 10, 2006, which is incorporated by reference into Jones; Jones2 discloses in Figure 4, stretch resistant member (26b); Paragraph [0032] of Jones2) for resisting stretching or unwinding of the coil means (Paragraphs [0019]-[0022] and [0032] of Jones2; the member is formed of substantially non-ductile material such as PET or metallic alloys to bear axial load and resist stretching/unwinding of the coil) extending through the interior of the coil means (Figure 2 and Paragraph [0032] of Jones2), wherein the stretch resistant means (stretch resistant member (26b)) comprises a stopper means (Figure 4 of Jones2, enlarged portion (28a); Paragraph [0032] of Jones2).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the embolic coil device of Purdy to make the band as a radiopaque marker band as taught by Fitz, and further modify the embolic coil device of Purdy with the coil means of Jones/Jones2 such that it possess stretch resistant means for resisting stretching or unwinding of the coil means extending through the radiopaque marker band and into the interior of the coil means as taught by Jones/Jones2, as all the references and the claimed invention are directed to endovascular embolic coil devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embolic coil device of Purdy to make the band as a radiopaque marker band as taught by Fitz, and further modify the embolic coil device of Purdy with the coil means of Jones/Jones2 such that it possess stretch resistant means for resisting stretching or unwinding of the coil means extending through the radiopaque marker band and into the interior of the coil means as taught by Jones/Jones2, as such a modification would have been predictable, namely, to convert Purdy’s temporary stretch resistant means into permanent stretch-resistant means that remains inside the coil means after detachment, thereby preventing unwanted stretching or unwinding of the coiled means during delivery or repositioning while still utilizing Purdy’s stop-means-to-radiopaque-marker-band stop mechanism at the proximal end. Furthermore, a person of ordinary skill in the art would have been motivated to make this modification because Jones explicitly teaches that adding a distally-anchored stretch-resistant means extending through the coil means interior provides improved resistance to stretching/unwinding (see Jones2, Paragraphs [0019]-[0022] and [0032]), which is a known problem in soft embolic coils, and applying this known improvement to Purdy’s coil (which already has a proximal radiopaque marker band and stop means-based stop) would yield the predictable benefit of a more robust, stretch-resistant implant without compromising the traction detachment function. This combination results in the stretch resistant means extending into the interior of the coil means, with the stopper means preventing the stretch resistant means from withdrawing into the radiopaque marker band, as required by the claim (KSR v. Teleflex; MPEP 2143(A), (C) – combining known elements according to known methods to yield predictable results and applying a known technique to a known device for improvement).
Regarding claim 31, modified Purdy teaches, wherein the radiopaque marker band is comprised of a hypotube (Jones, Paragraphs [0016]-[0017]; hypotube (21) is explicitly used to form the headpiece at the proximal end of the coil) (It would have been obvious to use a hypotube for the radiopaque marker band in the modified Purdy device for the reasons given in claim 20 (hypotubes are a known, conventional proximal attachment structure in embolic coils for secure pusher interface and controlled detachment)).
Regarding claim 32, modified Purdy teaches, wherein the stretch resistant means is comprised of a tether (tether under the broadest reasonable interpretation (BRI) is “a line to which someone or something is attached”, as such, guide wire (16) is indeed a “tether”. Further, stretch resistant member (26b) of Jones/Jones is also considered a “tether”).
Regarding claim 33, Purdy teaches, the stopper means (attachment point (20))
Purdy fails to teach, wherein the stopper means is comprised of a knot.
Fitz teaches, a stretch resistant means (Figure 4, tether (310)) comprising a stopper means (Figure 4, knot (316)), wherein the stopper means is comprised of a knot (knot (316) is explicitly used to tie tether (310) around the proximal end of the implant device (302) as seen in Figure 4) (Paragraph [0053]).
Jones teaches, aspects of the embolic coil device according to claim 20 (See above rejection of claim 20).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the embolic coil device of Purdy to form the stopper means as a knot as taught by Fitz, as all the references and the claimed invention are directed to endovascular embolic coil devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embolic coil device of Purdy to form the stopper means as a knot as taught by Fitz, as such a modification would have been predictable, namely, a knot is a simple, predictable, and commonly used way to create a reliable stopper means on a filamentary tether/stretch resistant means that cannot pass through the tubular lumen/radiopaque marker band (Paragraphs [0007] and [0053] of Fitz).
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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