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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 17, 2026 has been entered.
Claims 1-10, 12-15 and 18-20 are currently pending.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Phelps et al. (US 5,382,259, hereinafter “Phelps”) in view of Wallace et al. (US 2014/0277099, hereinafter “Wallace”).
Regarding claim 14, Phelps discloses the invention substantially as claimed including a vascular implant (120, Fig 3) configured for occluding a vasculature of a patient (col 1, ln 15-19), the vascular implant comprising:
a biocompatible polymeric structure formed of a plurality of filaments (130) and having a proximal end and a distal end (col 2, ln 54-60), the filaments spaced to maintain surface porosity (openings between strands or filaments – Fig 3), the polymeric structure forming a tubular body having a first longitudinally extending opening (Fig 3; col 2, ln 54-60); and
an inner element composed of a radiopaque coil (122) (col 2, ln 39-41) having a proximal end and a distal end, the radiopaque coil positioned within the longitudinally extending opening of the polymeric structure, wherein the polymeric structure and radiopaque coil are attached to form a joint at the distal end of the radiopaque coil along a length wherein the joint covers at least two distalmost coil windings (fixedly attached to entire coil 122, including the two distalmost coil windings) of the radiopaque coil (Fig 3; col 3, ln 7-13).
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However, Phelps fails to disclose a detailed description of the braid structure of the biocompatible polymeric structure formed of a plurality of filaments (130) and fails to disclose the filaments provide a closed-cell structure while maintaining surface porosity. Wallace discloses a vascular implant configured for occluding a vasculature of a patient comprising a biocompatible polymeric structure formed from a plurality of filaments (braided tubular member) and an inner coil (para [0113]). Wallace teaches “the expandable braided tubular members described herein are typically porous, as they are expandable braids, but have a constrained pore-size formed by the braid. For example, the braided elongate tubes may have a pore size that is sufficiently small to prevent substantial blood flow (and particularly small enough to prevent passage of a clot) through the pores. For example, a braided tubular member may have a pore size formed between strands in the expanded configuration of less than about 0.1 square mm.” (para [0019]). Due to the small pore-size for preventing substantial blood flow, the filaments forming the braid are interpreted as being “spaced to provide a closed-cell structure while maintaining surface porosity”. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Phelps such that the braid structure had a sufficiently small pore size to prevent blood flow, as taught by Wallace, and thus have filaments spaced to provide a closed-cell structure while maintaining surface porosity for the purpose of improving the occlusive properties of the vascular implant.
Regarding claim 15, wherein the joint of the polymeric structure (130) and radiopaque coil (122) is formed by application of energy to bond the polymeric structure and radiopaque coil or by an adhesive to bond the polymeric structure and radiopaque coil (col 2, ln 60-66 – materials of woven or braided member 130 are melted or fused to coils, or glued, which would form the joint).
Claim(s) 1-7, 13, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Phelps (US 5,382,259) in view of Wallace (US 2014/0277099) and Jones et al. (US 2008/0097508, hereinafter “Jones”).
Regarding claims 1 and 7, Phelps discloses the invention substantially as claimed including a vascular implant (134, Fig 5) configured for occluding a vasculature of a patient (col 1, ln 15-19), the vascular implant comprising:
a biocompatible polymeric structure formed of a plurality of filaments (130) and having a proximal end and a distal end (col 2, ln 54-60), the filaments spaced to maintain surface porosity (openings between strands or filaments – Fig 5), the polymeric structure forming a tubular body having a first longitudinally extending opening (Fig 3; col 2, ln 54-60); and
a radiopaque coil (136) (col 2, ln 39-41) having a proximal end and a distal end, the radiopaque coil positioned within the longitudinally extending opening of the polymeric structure, wherein the polymeric structure and radiopaque coil are attached forming a joint at the distal end of the radiopaque coil along a length (Fig 5; col 2, ln 62-66; col 3, ln 32-46).
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Phelps fails to disclose a detailed description of the braid structure of the biocompatible polymeric structure formed of a plurality of filaments (130) and fails to disclose the filaments provide a closed-cell structure while maintaining surface porosity. Wallace discloses a vascular implant configured for occluding a vasculature of a patient comprising a biocompatible polymeric structure formed from a plurality of filaments (braided tubular member) and an inner coil (para [0113]). Wallace teaches “the expandable braided tubular members described herein are typically porous, as they are expandable braids, but have a constrained pore-size formed by the braid. For example, the braided elongate tubes may have a pore size that is sufficiently small to prevent substantial blood flow (and particularly small enough to prevent passage of a clot) through the pores. For example, a braided tubular member may have a pore size formed between strands in the expanded configuration of less than about 0.1 square mm.” (para [0019]). Due to the small pore-size for preventing substantial blood flow, the filaments forming the braid are interpreted as being “spaced to provide a closed-cell structure while maintaining surface porosity”. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Phelps such that the braid structure had a sufficiently small pore size to prevent blood flow, as taught by Wallace, and thus have filaments spaced to provide a closed-cell structure while maintaining surface porosity for the purpose of improving the occlusive properties of the vascular implant.
Phelps fails to disclose the length of the joint along which the radiopaque coil is fixed to the polymeric structure. Jones discloses a similar vascular implant (Figs 1, 3) comprising an outer tubular structure (14) and an inner coil (12), wherein the outer tubular structure and inner coil are attached to form a joint at the distal and proximal ends of the implant and further teaches joints may be formed at any position or a number of places along the length of the implant (para [0032]), thus establishing the length of the joint as a result effective variable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Phelps such that the joint was formed at the distal end of the radiopaque coil along a length extending for at least .002 inches and not exceeding a length of about .050 inches or along a length of about 0.004 inches to about 0.020 inches, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In the embodiment of Fig 5, Phelps fails to disclose the polymeric structure (130) covering the distal end of the radiopaque coil (136). However, in alternative embodiments, including the embodiment of Fig 3 discussed above, Phelps teaches the polymeric structure (130) covers the distal end of the radiopaque coil (122) (col 3, ln 7-11). Furthermore, Jones teaches a similar vascular implant (Figs 1, 3) comprising an outer tubular structure (14) and an inner coil (12), wherein the outer tubular structure does not cover the distal end of the inner coil (Fig 1) in a first embodiment and wherein the outer tubular structure does cover the distal end of the inner coil in a second embodiment (Fig 3) (para [0032]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Phelps such that the polymeric structure covered the distal end of the of the radiopaque coil for the purpose of improving the occlusive capability of the device and since substitution of one known element (an outer tube covering the entire coil) for another element (an outer tube covering only a portion of a the coil) providing the same function to yield predictable results would have been obvious to one of ordinary skill in the art at the time of the invention.
Regarding claim 2, Phelps teaches wherein the joint is formed where the polymeric structure covers at least two coil windings of the radiopaque coil (Fig 5).
Regarding claim 3, in the modified device of Phelps in view of Jones, the polymeric structure covers the distal end of the radiopaque coil and it is obvious the joint will be at the end of the radiopaque coil, including the two distalmost windings of the radiopaque coil, since the joint is at the distal end of the polymeric structure.
Regarding claim 4, Phelps teaches wherein the two coil windings are spaced proximally of a distalmost end of the radiopaque coil (Fig 5).
Regarding claim 5, wherein the joint of the polymeric structure and radiopaque coil is formed by application of energy to bond the polymeric structure and radiopaque coil (col 2, ln 60-66 – materials of woven or braided member 130 are melted or fused to coils, or glued, which would form the joint).
Regarding claim 6, wherein the joint of the polymeric structure and radiopaque coil is formed by an adhesive to bond the polymeric structure and radiopaque coil (col 2, ln 60-66 – materials of woven or braided member 130 are melted or fused to coils, or glued, which would form the joint).
Regarding claim 13, wherein the polymeric structure and radiopaque coil are attached so that the joint extends continuously along a length of the joint (col 2, ln 60-66 – materials of woven or braided member 130 are melted or fused to coils, or glued, which would form the joint).
Regarding claim 18, Phelps discloses the invention substantially as claimed including a vascular implant (134, Fig 5) configured for occluding a vasculature of a patient (col 1, ln 15-19), the vascular implant comprising:
a biocompatible polymeric structure formed of a plurality of filaments (130) and having a proximal end and a distal end (col 2, ln 54-60), the filaments spaced to maintain surface porosity (openings between strands or filaments – Fig 5), the polymeric structure forming a tubular body having a first longitudinally extending opening (Fig 3; col 2, ln 54-60); and
an inner element composed of a radiopaque coil (136) (col 2, ln 39-41) having a proximal end and a distal end, the radiopaque coil positioned within the longitudinally extending opening of the polymeric structure, wherein the polymeric structure and radiopaque coil are attached forming a joint at the distal portion of the radiopaque coil along a length (Fig 5; col 2, ln 62-66; col 3, ln 32-46).
Phelps fails to disclose a detailed description of the braid structure of the biocompatible polymeric structure formed of a plurality of filaments (130) and fails to disclose the filaments provide a closed-cell structure while maintaining surface porosity. Wallace discloses a vascular implant configured for occluding a vasculature of a patient comprising a biocompatible polymeric structure formed from a plurality of filaments (braided tubular member) and an inner coil (para [0113]). Wallace teaches “the expandable braided tubular members described herein are typically porous, as they are expandable braids, but have a constrained pore-size formed by the braid. For example, the braided elongate tubes may have a pore size that is sufficiently small to prevent substantial blood flow (and particularly small enough to prevent passage of a clot) through the pores. For example, a braided tubular member may have a pore size formed between strands in the expanded configuration of less than about 0.1 square mm.” (para [0019]). Due to the small pore-size for preventing substantial blood flow, the filaments forming the braid are interpreted as being “spaced to provide a closed-cell structure while maintaining surface porosity”. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Phelps such that the braid structure had a sufficiently small pore size to prevent blood flow, as taught by Wallace, and thus have filaments spaced to provide a closed-cell structure while maintaining surface porosity for the purpose of improving the occlusive properties of the vascular implant.
Phelps fails to disclose the length of the joint along which the radiopaque coil is fixed to the polymeric structure. Jones discloses a similar vascular implant (Figs 1, 3) comprising an outer tubular structure (14) and an inner coil (12), wherein the outer tubular structure and inner coil are attached to form a joint at the distal and proximal ends of the implant and further teaches joints may be formed at any position or a number of places along the length of the implant (para [0032]), thus establishing the length of the joint as a result effective variable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Phelps such that the joint was formed at the distal end of the radiopaque coil along a length extending for at least .002 inches and not exceeding a length of about .050 inches or along a length of about 0.004 inches to about 0.020 inches, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Phelps fails to disclose the polymeric structure and the radiopaque coil are attached at a plurality of discrete spaced apart non-continuous regions along the length of the joint. Phelps broadly teaches the polymeric structure and radiopaque coil may be alternatively “glued or otherwise fastened” together (col 2, ln 63) and Jones broadly teaches “It is contemplated that the generally tubular element could be connected to the inner embolic device in any number of places” (para [0032]). Therefore, it would have been obvious to one of ordinary skill in the art to try to attach the polymeric structure and radiopaque coil at a plurality of discrete spaced apart non-continuous regions along the length of the joint when applying the adhesive or glue or otherwise fastening the two members together in attempt to provide an improved joint, as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp and since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success.
Regarding claim 19, wherein the filaments form a plurality of yarns (col 2, ln 54-66; col 3, ln 1-6), the plurality of yarns having spaces therebetween for blood inflow between the yarns (Figs 1-5; col 2, ln 54-66; openings or pores formed in braid from yarns).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Phelps (US 5,382,259), Wallace (US 2014/0277099), and Jones (US 2008/0097508), as applied to claim 1 above, further in view of Martinez (US 2005/0171572, hereinafter “Martinez”).
Regarding claim 8, Phelps and Jones disclose the invention substantially as claimed, as shown above. However, Phelps fails to disclose a metal tube attached to a proximal end of the radiopaque coil, wherein the polymeric structure and metal tube are attached to form a proximal joint along a length extending for at least .002 inches and not exceeding a length of about .050 inches.
Martinez discloses a similar vasoocclusive device (10, Figs 1-9) for occluding the vasculature of patient having a biocompatible tubular structure (12, 13) and further having a coiled element (11) inside the tubular structure where the coiled element has a coiled structure (para [0026], Figs 1-4) and a metal tube (16, 16’, Figs. 2, 4, 9) secured to a and positioned within coils of the coiled structure, wherein the metal tube is attached to a proximal end of the radiopaque coil, wherein the polymeric structure and metal tube are attached to form a proximal joint along a length (distal end of 16, 16’ is attached to 11 by soldering or welding, paras [0043], [0051]; Figs. 2, 4, 9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the coiled element of Phelps with the metal tube as taught by Martinez in order to provide the advantage of a detachable coupling for use with a deployment device (Martinez, para [0043]). Martinez teaches that a length or position of the proximal joint is a result effective variable and that the attachment between the metal tube and mesh polymeric structure can be at any position or number of places including at a plurality of discrete regions at a distal portion, and the mesh polymeric structure can expand in between the attachment areas (see para [0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the implant of Phelps wherein the polymeric structure and metal tube are attached to form a proximal joint along a length extending for at least .002 inches and not exceeding a length of about .050 inches, for the purpose of adjusting the attachment locations or positions as taught by Martinez, and in order to change the flexibility of the outer tubular polymeric structure and the expansion capabilities of the polymeric structure in order to occlude or fill the treatment site, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 9, Phelps as modified discloses the implant of claim 8, and Martinez further teaches wherein the proximal joint of the polymeric structure and metal tube is formed by one of application of energy or an adhesive to bond the polymeric structure and metal tube (soldering or welding, para [0051]).
Regarding claim 10, Phelps as modified discloses the implant of claim 8, and Martinez further teaches wherein the polymeric structure is further attached to the radiopaque coil to form the proximal joint, the proximal joint formed by one of application of energy or an adhesive to bond the polymeric structure, metal tube and radiopaque coil (soldering or welding, paras [0043] and [0051]).
Claim(s) 12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Phelps (US 5,382,259), Wallace (US 2014/0277099), and Jones (US 2008/0097508), as applied to claims 1 and 19 above, further in view of Zilla (US 2007/0293932, hereinafter “Zilla”). Phelps and Jones disclose the invention substantially as claimed, as shown above, but fail to disclose the polymeric structure has a series of peaks and valleys along a surface of a wall to increase flexibility, the peaks and valleys formed by crimping of the polymeric structure. Zilla discloses a vascular stent graft comprising a textile structure formed of a plurality of filaments (165) and teaches the fibers are crimped during manufacture to form a series of peaks and valleys along a surface of the outer wall thereof to improve the resiliency and compliance of the textile structure (para [0015, 0105,0106]). It is obvious the crimp would increase a flexibility along a surface of the wall and also a thrombogenic surface area of the textile structure due to the geometry of the crimped fibers and the peaks and valleys. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Phelps such that textile structure was crimped to improve the resiliency and compliance of the textile structure as well as the thrombogenic surface area of the textile structure.
Response to Arguments
Applicant's arguments filed June 17, 2026 have been fully considered but they are not persuasive.
Applicant argues the combination of Phelps (US 5,382,259) and Wallace (US 2014/0277099) fails to disclose a biocompatible polymeric structure formed of a plurality of filaments, wherein “the filaments [are] spaced to provide a closed-cell structure while maintaining surface porosity”. In particular, Applicant argues Wallace’s teaching of a “constrained pore-size” that prevents “substantial blood flow” through the pores is fundamentally different from the closed-cell structure recited in the claims. The Examiner respectfully disagrees. As noted above, Wallace teaches “the expandable braided tubular members described herein are typically porous, as they are expandable braids, but have a constrained pore-size formed by the braid. For example, the braided elongate tubes may have a pore size that is sufficiently small to prevent substantial blood flow (and particularly small enough to prevent passage of a clot) through the pores. For example, a braided tubular member may have a pore size formed between strands in the expanded configuration of less than about 0.1 square mm.” (para [0019]). The Examiner maintains that due to the small pore-size for preventing substantial blood flow, the filaments forming the braid are interpreted as being “spaced to provide a closed-cell structure while maintaining surface porosity”.
Applicant argues “Wallace describes expandable braids that are "typically porous" and merely have a constrained pore-size to prevent passage of clots. Wallace's braided tubular members are designed to expand from a collapsed configuration to an expanded configuration having a diameter "greater than 1.5 times the diameter of the inner member." This expansion necessarily increases the spacing between filaments and creates an open-cell structure.” (page 8 of Remarks). The Examiner respectfully disagrees that the expandable braided configuration necessarily increases the spacing between filaments and creates an open-cell structure. Wallace clearly teaches the pore size is sufficiently small during use, and thus in the expanded configuration, to occlude blood (para [0128]). Applicant has failed to provide evidence Wallace teaches the expandable braids have an open-cell structure as argued. Applicant has provided no evidence to establish an unobvious difference between the claimed product and the prior art, but rather has merely argued such alleged difference. Mere arguments cannot take the place of evidence. In re Walters, 168 F.2d 79,80, 77 USPQ 609,610 (CCPA 1948); In re Cole, 326 F.2d. 769,773, 140 USPQ 230,233 (CCPA 1964); In re Schulze, 346 F.2d 600,602, 145 USPQ 716,718 (CCPA 1965); In re Lindner, 457 F.2d 506,508, 173 USPQ 356,358 (CCPA 1972); In re Pearson, 494 F.2d 1399,1405, 181 USPQ 641,646 (CCPA 1974); Meitzner v. Mindick, 549 F.2d 775,782, 193 USPQ 17,22 (CCPA), cert. Denied, 434 U.S. 854 (1977); In re DeBlauwe, 736 F.2d 699,705, 222 USPQ 191,196 (Fed. Cir. 1984).
Applicant argues the claimed closed-cell structure provides the triple capillary effect described in the specification, enabling blood absorption and retention that promotes rapid clotting. Furthermore, Applicant states the specific closed-cell configuration claimed, which enables the textile structure to function as a capillary tube, cannot be achieved merely by constraining pore size. Claims 1, 14, and 18 each state: “the filaments spaced to provide a closed-cell structure while maintaining surface porosity”. The Examiner respectfully notes a porous structure typically has an opening to allow for porosity, which may be considered an open cell. Thus, the Examiner suggests clarifying the structure that differentiates Applicant’s porous structure to have the claimed closed cell configuration while still being porous, if merely constraining pore size will not provide a closed cell configuration as argued.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the lumen inside the textile structure is sufficiently small to function as a capillary tube, but the textile structure still has sufficient sized openings/spaces for absorbing blood through and along the yarns and filaments OR the closed cell structure forming such small openings that the inner element, i.e. the core element, covered by the textile structure is not visible through the outer textile structure OR the textile structure being non-expanding, which maintain their closed-cell configuration in both delivery and placement positions because the diameter does not change) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Wallace teaches providing a braided structure having a sufficiently small pore size to improve the occlusive properties of the vascular implant.
Conclusion
All claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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