DETAILED ACTION
This action is in response to applicant's preliminary amendments filed 12/03/24.
The examiner acknowledges the amendments to the claims.
Claims 2-21 are pending in this application.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 3, 10, 13-14 are objected to because of the following informalities:
Claim 3 is recited as being dependent on claim 1 which is cancelled. For examination purposes, Claim 3 will be read as --The delivery device of claim 2--.
Claim 10, line 8 recites “wherein outer layer” and should rather read as --wherein the outer layer--.
Claim 13, lines 8-9 recite “the second region” and should instead read as --the at least one second coil region--.
Claim 14, line 8 recites “wherein outer layer” and should rather read as --wherein the outer layer--.
Appropriate correction is required.
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 21 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 21, line 6 recites the limitation "the support coil". There is insufficient antecedent basis for this limitation in the claim. It is also unclear if this limitation is referring to previously recited “a support means” in line 4 of Claim 21. For examination purposes, the limitation in line 6 will be read as --support means--.
Additionally, lines 7-8 of Claim 21 recite in two instances “a coil density”, and it is unclear if the coil density characterizes a “support means” or “a support coil”. As indicated below, the limitation of a coil density would provide sufficient structure of a coil so that “support means” would not be interpreted under 35 U.S.C. 112(f). Therefore, for examination purposes the limitation in line 6 will be read as --support means—which does not invoke 35 U.S.C. 112(f).
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “support means” in claim 21, which further recites sufficient structure in the limitation (the support means having a “coil density”).
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-3, and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Teoh et al., hereinafter “Teoh” (U.S. Pub. No. 2010/0160944) in view of Chen et al., hereinafter “Chen” (U.S. Pub. No. 2011/0118776).
Regarding claim 2, Teoh discloses a delivery device (Figure 1) comprising:
an implant 10 releasably located at a distal end of the delivery device ([0042]; implant is released at detachment region 75);
a heater (heater coil 60 [0042]-[0043]) configured to detach the implant when being activated (Id.); and
a support coil 50 configured to provide structural support to the delivery device, wherein the support coil is located at a proximal end of the heater, and wherein the support coil comprises a center region at a middle portion of the support coil, a distal region at a distal end of the support coil, and a proximal region at a proximal end of the support coil (Figure 1).
However, Teoh does not disclose a coil density of the center region being higher than a coil density of the distal region and the proximal region.
In the same field of art, namely delivery devices, in Figures 5-7 Chen teaches a support coil 256 ([0052]) configured to provide structural support to delivery device 200, wherein the support coil comprises a center region (closed pitch area 262) at a middle portion of the support coil, a distal region (distal open pitch area 263) at a distal end of the support coil, and a proximal region (proximal open pitch area 261) at a proximal end of the support coil, and a coil density of the center region being higher than a coil density of the distal region and the proximal region (Id. the closed pitch is denser than the open pitch; also see [0051] of provisional application no. 61/262,394).
It would have been obvious to one of ordinary skill at the time of invention to modify the support coil of Teoh such that a coil density of the center region is higher than a coil density of the distal region and the proximal region, as taught by Chen, since the varying coil densities create rigid and flexible areas, wherein increasing the number of rigid and flexible segments increases and facilitates sectional bending as the delivery device is navigated through the highly tortuous paths of a patient’s vasculature (Chen; [0052], [0055]; also see [0054] of provisional application no. 61/262,394).
Regarding claim 3, Teoh as modified teaches a core wire 40 connected to the
proximal end of the support coil 50 (Teoh; Figure 1).
Regarding claim 21, Teoh discloses a delivery device (Figure 1) comprising:
an implant 10 releasably located at a distal end of the delivery device ([0042]; implant is released at detachment region 75);
a heater (heater coil 60 [0042]-[0043]) configured to detach the implant when being activated (Id.); and
a support means (coil 50) configured to provide structural support to the delivery device, wherein the support means is located at a proximal end of the heater, and wherein the support means comprises a center region at a middle portion of the support coil (means), a distal region at a distal end of the support means, and a proximal region at a proximal end of the support means (Figure 1).
However, Teoh does not disclose a coil density of the center region being higher than a coil density of the distal region and the proximal region.
In the same field of art, namely delivery devices, in Figures 5-7 Chen teaches a support coil 256 ([0052]) configured to provide structural support to delivery device 200, wherein the support coil comprises a center region (closed pitch area 262) at a middle portion of the support coil, a distal region (distal open pitch area 263) at a distal end of the support coil, and a proximal region (proximal open pitch area 261) at a proximal end of the support coil, and a coil density of the center region being higher than a coil density of the distal region and the proximal region (closed pitch being denser than open pitch, Id.; also see [0051] of provisional application no. 61/262,394 of Chen).
It would have been obvious to one of ordinary skill at the time of invention to modify the support means of Teoh such that a coil density of the center region is higher than a coil density of the distal region and the proximal region, as taught by Chen, since the varying coil densities create rigid and flexible areas, wherein increasing the number of rigid and flexible segments increases and facilitates sectional bending as the delivery device is navigated through the highly tortuous paths of a patient’s vasculature (Chen; [0052], [0055]; also see [0054] of provisional application no. 61/262,394).
Claim 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Teoh (U.S. Pub. No. 2010/0160944) in view of Chen (U.S. Pub. No. 2011/0118776), as applied to claim 3 above.
Regarding claim 9, Teoh as modified teaches the claimed invention, as discussed above, except does not expressly teach the core wire comprises at least one
radiopaque material, although Teoh teaches in [0050] that “one or more of the components” of the device may comprise radiopaque materials which may be coated using any suitable method or may be incorporated into the element. Teoh further teaches in [0054] a distal end of a delivery device may have a radiopaque element to facilitate visualization during positioning within the vascular system.
It would have been obvious to one of ordinary skill at the time of invention to modify the core wire of Teoh as modified such that the core wire comprises at least one radiopaque material since the core wire 40 in Teoh is positioned in a distal portion of the delivery device (Figure 1) and would facilitate visualization during advancement within the vascular system.
Claim 10 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Teoh (U.S. Pub. No. 2010/0160944) in view of Chen (U.S. Pub. No. 2011/0118776), as applied to claim 9 above, and further in view of Urick (U.S. Patent No. 5,836,893).
Regarding claim 10, Teoh as modified teaches the claimed invention, as discussed above, including the core wire comprises: a core mandrel 40 (Teoh, Figure 1) comprising: a proximal portion; a middle portion; and a distal portion, wherein the core mandrel is composed of a first radiopaque material (Teoh; [0050], [0054]). However, Teoh as modified does not teach an outer layer covering the proximal portion of the core mandrel and the middle portion of the core mandrel, wherein the outer layer is composed of a second radiopaque material, wherein the second radiopaque material has a lower radiopaque value than the first radiopaque material.
Urick teaches in Figure 7 a core mandrel 18 having an outer layer 106 covering a proximal portion 22 of the core mandrel and a middle portion 24/28 of the core mandrel (proximal to distal portion 30/32), wherein the outer layer is composed of a second radiopaque material, wherein the second radiopaque material has a lower radiopaque value than a first radiopaque material (col. 7, line 57 to col. 8, line 39; the core mandrel has a first radiopaque material at a distal portion 108 with greater radiopacity, wherein the outer layer 106 has a second radiopaque material that is less radiopaque than the first radiopaque material). The difference in radiopacity gives the distal portion a relatively greater visibility while allowing the middle and proximal portions to be visible (Id.). Furthermore, it may be desirable to have a portion of the core mandrel proximal to the distal portion to be less radiopaque so as to not visibly obscure the vessel after the distal portion has crossed a target site (col. 1, lines 46-49).
It would have been obvious to one of ordinary skill at the time of invention to modify the core mandrel of Teoh as modified with an outer layer covering the proximal portion of the core mandrel and the middle portion of the core mandrel, wherein outer layer is composed of a second radiopaque material, wherein the second radiopaque material has a lower radiopaque value than the first radiopaque material, as taught by Urick, in order to have a distal tip portion of the delivery device be easily visible during the procedure for accurate tracking.
Claims 11-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Teoh (U.S. Pub. No. 2010/0160944) in view of Chen (U.S. Pub. No. 2011/0118776) and Urick (U.S. Patent No. 5,836,893), as applied to claim 10 above, and further in view of Moutafis et al., hereinafter “Moutafis” (U.S. Patent No. 5,333,620).
Regarding claims 11-12, Teoh as modified teaches the claimed invention, as discussed above, except for a thickness of the outer layer varies along a length of the core mandrel, and the outer layer has a first thickness over the proximal portion of the core mandrel and has a second thickness over the middle portion of the core mandrel, and wherein the first thickness is higher than the second thickness.
Moutafis teaches a core wire having a core mandrel 12 (Figure 1), having an outer layer 18 having a thickness that varies along a length of the core mandrel, and the outer layer has a first thickness over the proximal portion (near 44/42) of the core mandrel and has a second thickness over the middle portion (near 20) of the core mandrel, and wherein the first thickness is higher than the second thickness (the outer layer 18 has a tapering thickness from the proximal end towards the middle and distal end). It is noted that layer 14 in Figure 1 could also be considered as the “outer layer”, as it is on the exterior or outside of core mandrel 12, wherein the outer layer 14 has a first thickness at the proximal portion (near 44) that is higher than a second thickness at the intermediate portion (near 16). Moutafis teaches that the tapering core wire has a proximal stiffness and a distal flexibility, which improves steering and resistance to kinking (col. 2, line 66 - 68) during delivery.
Furthermore, a skilled artisan would understand that the thicker layer proximal portion of material is stiffer and improves steering at the proximal end, while the thinner layer intermediate portion is more flexible and increases resistance to kinking. It would have been obvious to one of ordinary skill before the effective filing date to modify the outer layer such the thickness of the outer layer varies along a length of the core mandrel as claimed, in order to facilitate advancement of the delivery device through a tortuous vasculature.
Claims 13-14 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Teoh (U.S. Pub. No. 2010/0160944) in view of Urick (U.S. Patent No. 5,836,893) and Chen (U.S. Pub. No. 2011/0118776).
Regarding claims 13 and 20, Teoh discloses a delivery device (Figure 1) comprising:
an implant 10 releasably located at a distal end of the delivery device ([0042]; implant is released at detachment region 75);
a heater coil 60 ([0042]-[0043]) configured to detach the implant when being activated (Id.);
a core wire 40;
a support coil 50 located between a proximal end of the heater coil and a distal end of the core wire 40, and wherein the support coil comprises a first coil region and at least one second coil region (Figure 1).
However, Teoh does not disclose the core wire comprising at least two radiopaque materials of different radiopaque values. Teoh teaches in [0050] that “one or more of the components” of the device may comprise radiopaque materials which may be coated using any suitable method or may be incorporated into the element. Teoh further teaches in [0054] a distal end of a delivery device may have a radiopaque element to facilitate visualization during positioning within the vascular system.
It would have been obvious to one of ordinary skill at the time of invention to modify the core wire of Teoh with a (first) radiopaque material since the core wire 40 in Teoh is positioned in a distal portion of the delivery device (Figure 1) and would facilitate visualization during advancement within the vascular system.
Urick teaches in Figure 7 a core wire comprising at least two radiopaque materials of different radiopaque values (col. 7, line 57 to col. 8, line 39; the core mandrel has a first radiopaque material at a distal portion 108 with greater radiopacity, wherein the outer layer 106 has a second radiopaque material that is less radiopaque than the first radiopaque material). The difference in radiopacity gives the distal portion of the core wire a relatively greater visibility while still allowing the middle and proximal portions to be visible (Id.). Furthermore, it may be desirable to have a portion of the core wire proximal to the distal portion to be less radiopaque so as to not visibly obscure the vessel after the distal portion has crossed a target site (col. 1, lines 46-49).
It would have been obvious to one of ordinary skill at the time of invention to modify the core wire of Teoh comprising at least two radiopaque materials of different radiopaque values, wherein the second radiopaque material has a lower radiopaque value than the first radiopaque material, as taught by Urick, in order to have a distal tip portion of the delivery device be easily visible during the procedure for accurate tracking.
Furthermore, Teoh does not disclose a coil density of the first coil region being higher than a coil density of the at least one second coil region. Furthermore, Teoh does not teach the support coil comprises two second coil regions, wherein the first coil region is positioned between the two second coil regions.
In the same field of art, namely delivery devices, in Figures 5-7 Chen teaches a support coil 256 ([0052]) configured to provide structural support to delivery device 200, wherein the support coil comprises a first coil region (closed pitch area 262) at a middle portion of the support coil, a second coil region (distal open pitch area 263) at a distal end of the support coil, and another second coil region (proximal open pitch area 261) at a proximal end of the support coil, and a coil density (closed) of the first coil region being higher than a coil density (open) of the two second coil regions (Id. the closed pitch is denser than the open pitch; also see [0051] of provisional application no. 61/262,394), and wherein the first coil region is positioned between the two second coil regions.
It would have been obvious to one of ordinary skill at the time of invention to modify the support coil of Teoh such that a coil density of the first coil region is higher than a coil density of the at least one second coil regions as claimed, as taught by Chen, since the varying coil densities create rigid and flexible areas, wherein increasing the number of rigid and flexible segments increases and facilitates sectional bending as the delivery device is navigated through the highly tortuous paths of a patient’s vasculature (Chen; [0052], [0055]; also see [0054] of provisional application no. 61/262,394).
Regarding claim 14, Teoh as modified teaches the claimed invention, as discussed above, including the core wire comprises: a core mandrel 40 (Teoh, Figure 1) comprising a first radiopaque material (Teoh, [0050],[0054]) and the core mandrel comprising: a proximal portion; a middle portion; and a distal portion.
However, Teoh as modified does not teach an outer layer covering the proximal portion of the core mandrel and the middle portion of the core mandrel, wherein the outer layer is composed of a second radiopaque material, wherein the second radiopaque material has a lower radiopaque value than the first radiopaque material.
Urick teaches in Figure 7 a core mandrel 18 having an outer layer 106 covering a proximal portion 22 of the core mandrel and a middle portion 24/28 of the core mandrel (proximal to distal portion 32/34), wherein the outer layer is composed of a second radiopaque material, wherein the second radiopaque material has a lower radiopaque value than a first radiopaque material (col. 7, line 57 to col. 8, line 39; the core mandrel has a first radiopaque material at a distal portion 108 with greater radiopacity, wherein the outer layer 106 has a second radiopaque material that is less radiopaque than the first radiopaque material). The difference in radiopacity gives the distal portion a relatively greater visibility while allowing the middle and proximal portions to be visible (Id.). Furthermore, it may be desirable to have a portion of the core mandrel proximal to the distal portion to be less radiopaque so as to not visibly obscure the vessel after the distal portion has crossed a target site (col. 1, lines 46-49).
It would have been obvious to one of ordinary skill at the time of invention to modify the core mandrel of Teoh as modified with an outer layer covering the proximal portion of the core mandrel and the middle portion of the core mandrel, wherein outer layer is composed of a second radiopaque material, wherein the second radiopaque material has a lower radiopaque value than the first radiopaque material, as taught by Urick, in order to have a distal tip portion of the delivery device be easily visible during the procedure for accurate tracking.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-8, 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 19 of U.S. Patent No. 12,114,864 and over claims 1, 4-7 of U.S. Patent No. 12114864 in view of Chen (U.S. Pub. No. 2011/0118776).
It is clear that claims 2-4 and 21, claim 6 are encompassed within patent claims 17 and 19, respectively.
It is also clear that elements of claims 2-4 are to be found in patent claim 1, except for features that are merely obvious. Chen teaches in Figures 5-7 a support coil 256 ([0052]) configured to provide structural support to delivery device 200, wherein the support coil comprises a center region (closed pitch area 262) at a middle portion of the support coil, a distal region (distal open pitch area 263) at a distal end of the support coil, and a proximal region (proximal open pitch area 261) at a proximal end of the support coil, and a coil density (closed) of the center region being higher than a coil density (open) of the distal region and the proximal region (Id. the closed pitch is denser than the open pitch; also see [0051] of provisional application no. 61/262,394).
It would have been obvious to one of ordinary skill at the time of invention to modify the patent claim such that a coil density of the center region is higher than a coil density of the distal region and the proximal region, as taught by Chen, since the varying coil densities create rigid and flexible areas, wherein increasing the number of rigid and flexible segments increases and facilitates sectional bending as the delivery device is navigated through the highly tortuous paths of a patient’s vasculature (Chen; [0052], [0055]; also see [0054] of provisional application no. 61/262,394).
It is also clear that elements of claims 5-8 are to be found in claims 5-7, 4, respectively.
Claims 9-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7 of U.S. Patent No. 12,114,864 in view of Chen (U.S. Pub. No. 2011/0118776), as applied to claim 3 above, and further in view of Teoh (U.S. Pub. No. 2010/0160944), Urick (U.S. Patent No. 5,836,893), Moutafis (U.S. Patent No. 5,333,620). The patent claims and Chen teach the claimed invention, as discussed above, including elements of claims 15-19 found in patent claims 1, 5-7, 4, respectively, except for features that are merely obvious (as discussed above).
Teoh teaches in [0050] that “one or more of the components” of a delivery device may comprise radiopaque materials which may be coated using any suitable method or may be incorporated into the element. Teoh further teaches in [0054] a distal end of a delivery device may have a radiopaque element to facilitate visualization during positioning within the vascular system. It would have been obvious to one of ordinary skill at the time of invention to modify the patent claims and Chen such that the core wire comprises at least one radiopaque material since the core wire 40 in Teoh is positioned in a distal portion of the delivery device (Figure 1) and would facilitate visualization during advancement within the vascular system.
Urick teaches in Figure 7 a core mandrel 18 having an outer layer 106 covering a proximal portion 22 of the core mandrel and a middle portion 24/28 of the core mandrel (proximal to distal portion 30/32), wherein the outer layer is composed of a second radiopaque material, wherein the second radiopaque material has a lower radiopaque value than a first radiopaque material (col. 7, line 57 to col. 8, line 39; the core mandrel has a first radiopaque material at a distal portion 108 with greater radiopacity, wherein the outer layer 106 has a second radiopaque material that is less radiopaque than the first radiopaque material). The difference in radiopacity gives the distal portion a relatively greater visibility while allowing the middle and proximal portions to be visible (Id.). Furthermore, it may be desirable to have a portion of the core mandrel proximal to the distal portion to be less radiopaque so as to not visibly obscure the vessel after the distal portion has crossed a target site (col. 1, lines 46-49). It would have been obvious to one of ordinary skill at the time of invention to modify the patent claims, Chen, and Teoh with an outer layer covering the proximal portion of the core mandrel and the middle portion of the core mandrel, wherein outer layer is composed of a second radiopaque material, wherein the second radiopaque material has a lower radiopaque value than the first radiopaque material, as taught by Urick, in order to have a distal tip portion of the delivery device be easily visible during the procedure for accurate tracking.
Moutafis teaches a core wire having a core mandrel 12 (Figure 1), having an outer layer 18 having a thickness that varies along a length of the core mandrel, and the outer layer has a first thickness over the proximal portion (near 44/42) of the core mandrel and has a second thickness over the middle portion (near 20) of the core mandrel, and wherein the first thickness is higher than the second thickness (the outer layer 18 has a tapering thickness from the proximal end towards the middle and distal end). It is noted that layer 14 in Figure 1 could also be considered as the “outer layer”, as it is on the exterior or outside of core mandrel 12, wherein the outer layer 14 has a first thickness at the proximal portion (near 44) that is higher than a second thickness at the intermediate portion (near 16). Moutafis teaches that the tapering core wire has a proximal stiffness and a distal flexibility, which improves steering and resistance to kinking (col. 2, line 66 - 68) during delivery. Furthermore, a skilled artisan would understand that the thicker layer proximal portion of material is stiffer and improves steering at the proximal end, while the thinner layer intermediate portion is more flexible and increases resistance to kinking. It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims and Chen and Teoh such the thickness of the outer layer varies along a length of the core mandrel as claimed, in order to facilitate advancement of the delivery device through a tortuous vasculature.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-9 of U.S. Patent No. 11,357,513 in view of Chen (U.S. Pub. No. 2011/0118776), Teoh (U.S. Pub. No. 2010/0160944), Urick (U.S. Patent No. 5,836,893), Moutafis (U.S. Patent No. 5,333,620). It is clear that elements of the application claims are to be found in the patent claims, except for features that are merely obvious.
Chen teaches in Figures 5-7 a support coil 256 ([0052]) configured to provide structural support to delivery device 200, wherein the support coil comprises a center region (closed pitch area 262) at a middle portion of the support coil, a distal region (distal open pitch area 263) at a distal end of the support coil, and a proximal region (proximal open pitch area 261) at a proximal end of the support coil, and a coil density (closed) of the center region being higher than a coil density (open) of the distal region and the proximal region (Id. the closed pitch is denser than the open pitch; also see [0051] of provisional application no. 61/262,394). It would have been obvious to one of ordinary skill at the time of invention to modify the patent claims such that a coil density of the center region is higher than a coil density of the distal region and the proximal region, as taught by Chen, since the varying coil densities create rigid and flexible areas, wherein increasing the number of rigid and flexible segments increases and facilitates sectional bending as the delivery device is navigated through the highly tortuous paths of a patient’s vasculature (Chen; [0052], [0055]; also see [0054] of provisional application no. 61/262,394).
Teoh teaches in [0050] that “one or more of the components” of a delivery device may comprise radiopaque materials which may be coated using any suitable method or may be incorporated into the element. Teoh further teaches in [0054] a distal end of a delivery device may have a radiopaque element to facilitate visualization during positioning within the vascular system. It would have been obvious to one of ordinary skill at the time of invention to modify the patent claims and Chen such that the core wire comprises at least one radiopaque material since the core wire 40 in Teoh is positioned in a distal portion of the delivery device (Figure 1) and would facilitate visualization during advancement within the vascular system.
Urick teaches in Figure 7 a core mandrel 18 having an outer layer 106 covering a proximal portion 22 of the core mandrel and a middle portion 24/28 of the core mandrel (proximal to distal portion 30/32), wherein the outer layer is composed of a second radiopaque material, wherein the second radiopaque material has a lower radiopaque value than a first radiopaque material (col. 7, line 57 to col. 8, line 39; the core mandrel has a first radiopaque material at a distal portion 108 with greater radiopacity, wherein the outer layer 106 has a second radiopaque material that is less radiopaque than the first radiopaque material). The difference in radiopacity gives the distal portion a relatively greater visibility while allowing the middle and proximal portions to be visible (Id.). Furthermore, it may be desirable to have a portion of the core mandrel proximal to the distal portion to be less radiopaque so as to not visibly obscure the vessel after the distal portion has crossed a target site (col. 1, lines 46-49). It would have been obvious to one of ordinary skill at the time of invention to modify the patent claims, Chen, and Teoh with an outer layer covering the proximal portion of the core mandrel and the middle portion of the core mandrel, wherein outer layer is composed of a second radiopaque material, wherein the second radiopaque material has a lower radiopaque value than the first radiopaque material, as taught by Urick, in order to have a distal tip portion of the delivery device be easily visible during the procedure for accurate tracking.
Moutafis teaches a core wire having a core mandrel 12 (Figure 1), having an outer layer 18 having a thickness that varies along a length of the core mandrel, and the outer layer has a first thickness over the proximal portion (near 44/42) of the core mandrel and has a second thickness over the middle portion (near 20) of the core mandrel, and wherein the first thickness is higher than the second thickness (the outer layer 18 has a tapering thickness from the proximal end towards the middle and distal end). It is noted that layer 14 in Figure 1 could also be considered as the “outer layer”, as it is on the exterior or outside of core mandrel 12, wherein the outer layer 14 has a first thickness at the proximal portion (near 44) that is higher than a second thickness at the intermediate portion (near 16). Moutafis teaches that the tapering core wire has a proximal stiffness and a distal flexibility, which improves steering and resistance to kinking (col. 2, line 66 - 68) during delivery. Furthermore, a skilled artisan would understand that the thicker layer proximal portion of material is stiffer and improves steering at the proximal end, while the thinner layer intermediate portion is more flexible and increases resistance to kinking. It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims and Chen and Teoh such the thickness of the outer layer varies along a length of the core mandrel as claimed, in order to facilitate advancement of the delivery device through a tortuous vasculature.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-10, 12-13 of U.S. Patent No. 9,561,125 in view of Chen (U.S. Pub. No. 2011/0118776), Teoh (U.S. Pub. No. 2010/0160944), Urick (U.S. Patent No. 5,836,893), Moutafis (U.S. Patent No. 5,333,620). It is clear that elements of the application claims are to be found in the patent claims, except for features that are merely obvious.
Chen teaches in Figures 5-7 a support coil 256 ([0052]) configured to provide structural support to delivery device 200, wherein the support coil comprises a center region (closed pitch area 262) at a middle portion of the support coil, a distal region (distal open pitch area 263) at a distal end of the support coil, and a proximal region (proximal open pitch area 261) at a proximal end of the support coil, and a coil density (closed) of the center region being higher than a coil density (open) of the distal region and the proximal region (Id. the closed pitch is denser than the open pitch; also see [0051] of provisional application no. 61/262,394). It would have been obvious to one of ordinary skill at the time of invention to modify the patent claims such that a coil density of the center region is higher than a coil density of the distal region and the proximal region, as taught by Chen, since the varying coil densities create rigid and flexible areas, wherein increasing the number of rigid and flexible segments increases and facilitates sectional bending as the delivery device is navigated through the highly tortuous paths of a patient’s vasculature (Chen; [0052], [0055]; also see [0054] of provisional application no. 61/262,394).
Teoh teaches in [0050] that “one or more of the components” of a delivery device may comprise radiopaque materials which may be coated using any suitable method or may be incorporated into the element. Teoh further teaches in [0054] a distal end of a delivery device may have a radiopaque element to facilitate visualization during positioning within the vascular system. It would have been obvious to one of ordinary skill at the time of invention to modify the patent claims and Chen such that the core wire comprises at least one radiopaque material since the core wire 40 in Teoh is positioned in a distal portion of the delivery device (Figure 1) and would facilitate visualization during advancement within the vascular system.
Urick teaches in Figure 7 a core mandrel 18 having an outer layer 106 covering a proximal portion 22 of the core mandrel and a middle portion 24/28 of the core mandrel (proximal to distal portion 30/32), wherein the outer layer is composed of a second radiopaque material, wherein the second radiopaque material has a lower radiopaque value than a first radiopaque material (col. 7, line 57 to col. 8, line 39; the core mandrel has a first radiopaque material at a distal portion 108 with greater radiopacity, wherein the outer layer 106 has a second radiopaque material that is less radiopaque than the first radiopaque material). The difference in radiopacity gives the distal portion a relatively greater visibility while allowing the middle and proximal portions to be visible (Id.). Furthermore, it may be desirable to have a portion of the core mandrel proximal to the distal portion to be less radiopaque so as to not visibly obscure the vessel after the distal portion has crossed a target site (col. 1, lines 46-49). It would have been obvious to one of ordinary skill at the time of invention to modify the patent claims, Chen, and Teoh with an outer layer covering the proximal portion of the core mandrel and the middle portion of the core mandrel, wherein outer layer is composed of a second radiopaque material, wherein the second radiopaque material has a lower radiopaque value than the first radiopaque material, as taught by Urick, in order to have a distal tip portion of the delivery device be easily visible during the procedure for accurate tracking.
Moutafis teaches a core wire having a core mandrel 12 (Figure 1), having an outer layer 18 having a thickness that varies along a length of the core mandrel, and the outer layer has a first thickness over the proximal portion (near 44/42) of the core mandrel and has a second thickness over the middle portion (near 20) of the core mandrel, and wherein the first thickness is higher than the second thickness (the outer layer 18 has a tapering thickness from the proximal end towards the middle and distal end). It is noted that layer 14 in Figure 1 could also be considered as the “outer layer”, as it is on the exterior or outside of core mandrel 12, wherein the outer layer 14 has a first thickness at the proximal portion (near 44) that is higher than a second thickness at the intermediate portion (near 16). Moutafis teaches that the tapering core wire has a proximal stiffness and a distal flexibility, which improves steering and resistance to kinking (col. 2, line 66 - 68) during delivery. Furthermore, a skilled artisan would understand that the thicker layer proximal portion of material is stiffer and improves steering at the proximal end, while the thinner layer intermediate portion is more flexible and increases resistance to kinking. It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims and Chen and Teoh such the thickness of the outer layer varies along a length of the core mandrel as claimed, in order to facilitate advancement of the delivery device through a tortuous vasculature.
Allowable Subject Matter
Claims 4-8 and 15-19 would be allowable if a Terminal Disclaimer is filed to overcome the double patenting rejections set forth in this office action, and if rewritten
to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: None of the prior art of record, alone or in combination, teaches or renders obvious a delivery device including, inter alia, an implant releasably located at a distal end of the delivery device, a heater configured to detach the implant when being activated, a support coil, a core wire located proximal to the support coil, and a bare wire connected to and in electrical communication with the core wire at both a first location and a second location, as recited in claims 4 and 15. Also see similar reasons for allowable subject matter in the following parent applications: pages 20-24 of office action filed 02/28/2024 in application no. 17/663,368, page 2 of office action filed 02/16/2022 in application no. 19/698,151, and page 3 of office action filed 09/30/2016 in application 13/081,275.
The closest prior art of record Teoh (U.S. Pub. No. 2010/0160944), as discussed above, teaches a wire 30 (Figure 1) in electrical communication with core wire 40 ([0042], [0046]) however, the wire is not “bare” as claimed but is electrically insulated and the wire is not connected to the core wire at both a first location and a second location as claimed, but rather is connected to the core wire at a single location (distal end at Figure 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kelley et al. (U.S. Pub. No. 2002/0165537) teaches a delivery device in Figure 1A, wherein in a core mandrel 102 has a distal portion 112 having a greater radiopaque value than a middle and proximal portion 110/120 ([0070]).
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/DIANE D YABUT/Primary Examiner, Art Unit 3771