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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/13/2026 has been entered.
Response to Amendment
This Office action is in response to the applicant’s communication filed 08/13/2026.
Status of the claims:
Claims 1 – 13, 17, 18, and 20 are pending in the application.
Claims 10, 11, and 13 are amended.
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.
The rejection of claims 10 and 11 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 05/18/2026 have been withdrawn in light of the Applicant’s amendments filed 08/13/2023. Specifically, the rejection of claims 10 and 11, regarding the lack of clarity in the phrase "one or more bead members", has been withdrawn as the phrase has been amended appropriately.
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.
Claims 1 – 5, 7 – 14, and 17 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Perszyk et al (US 2018/0235658 A1) (previously cited) and in view of Chin et al (US 2012/0191012 A1) (previously cited) and Douk et al (US 6,183,420 B1) (previously cited).
Regarding claims 1, 10, and 11, Perszyk discloses a delivery device (introducer assembly 100 and delivery cable 200) for an occlusive implant (medical device 201) (abstract, paragraphs [0003], [0006], [0024 – 0026], [0029 – 0030], [0054 – 0058], and Figs. 1 – 5, 12), the delivery device comprising:
a delivery sheath (delivery sheath 203) having a proximal region, a distal tip region, and a lumen formed therein (paragraphs [0006 – 0007], [0024], [0030 – 0031], [0039 – 0040], and Fig. 2);
a core wire (delivery cable 200) slidably disposed in the lumen (paragraphs [0006 – 0007], [0032 – 0036], and Fig. 5, 12);
wherein the core wire (delivery cable 200) includes a central shaft (inner member 202), a first region (proximal section 206) having a first coil assembly (proximal outer member 210) disposed along the central shaft (inner member 202), a second region (distal section 204) having a second coil assembly (distal outer member 208) disposed along the central shaft, and a distal implant securing region (end screw 212) (paragraphs [0036 – 0040], [0055], and Fig. 12); and
an occlusive implant (implant 201) coupled to the distal implant securing region (paragraphs [0026], [0030], [0032], and Fig. 2);
a third coil assembly (intermediate outer member 240) disposed over the central shaft (inner member 202) for providing sufficient column strength to the core wire (paragraph [0054]) and defining an outer diameter approximately equal to an inner diameter of the lumen (paragraphs [0028], [0040], and [0058]) (Examiner’s note: the term “approximately” is defined as very close to but not equal to. As stated in paragraph [0040] the outer diameter of the distal outer member 208 is greater than 98% of the inner diameter of the delivery sheath, and because the outer diameter of the distal outer member 208 being within less than two percent of the inner diameter of the lumen of the delivery sheath the outer diameter of the distal outer member 208 is considered to be approximately equal to the inner diameter of the lumen. Furthermore, paragraph [0058] recites wherein the intermediate outer member 240 has the same outer diameter as the distal outer member 208. Therefore, Perszyk discloses the intermediate outer member 240 defines an outer diameter approximately equal to the inner diameter of the sheath (i.e., the lumen)).
However, Perszyk is silent regarding [claims 1, 10, and 11] (i) wherein the third coil assembly is a plurality of beads members disposed over the central shaft adjacent to the first region and/or disposed over the central shaft between the first region and the second region and (ii) wherein each of the plurality of beads members defines an outer diameter approximately equal to an inner diameter of the lumen.
As the above, Chin teaches guidewire (which equates to the delivery wire 200 of Perszyk) for an implant delivery catheter a core wire with a central shaft (core wire 101; which equates to the inner member 202 of Perszyk) comprising one or more bead members (beads 109) disposed along the length for the purpose of imparting a desired rigidity / controllable stiffness to the core wire (core wire 101) (abstract, paragraph [0004], [0009], [0019 – 0023], [0031], and Fig. 1A/B).
Additionally, Douk teaches an angioplasty guidewire with a core wire (core wire 162; which equates to the inner member 202 of Perszyk) comprising a central shaft (core wire 162) with a distal coil assembly (stiffening spring 168) or a plurality of beads (beads 175) for stiffening the core wire (core wire 162) (abstract, col. 8 lines 1 – 20, col. 8 lines 24 – 50, and Figs. 15,16). Therefore, Douk teaches coil assemblies and bead assemblies are functionally equivalent and are interchangeable without changing the principle operation of the system.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the intermediate coil assembly of Perszyk to incorporate / be replaced by a plurality of beads, based on the teachings of Chin in view of Douk, for the purpose of being able to impart a desired rigidity to the core wire (paragraph [0023] – Chin). Additionally, it should be understood that Perszyk and Chin with the teachings of Douk are known references in the art that teach a delivery system comprising a core wire with elements / members for stiffening and/or providing the desired strength and flexibility to an inner core (abstract, paragraphs [0005 – 0007], [0024 – 0026], [0054], [0058], and Figs. 1 – Perszyk ; abstract, paragraph [0004], [0009], [0019 – 0022], [0031], and Fig. 1A/B – Chin ; abstract, col. 8 lines 1 – 20, col. 8 lines 24 – 55, and Figs. 15,16 – Douk); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one known stiffening element for another (i.e., substituting the intermediate outer coil 240 for a series of beads), and the results of the substitution would have been predictable and resulted in the modified intermediate member being able to function as intended to provide the desired rigidity / flexibility to the core member as desired and resulted in the delivery cable 200 of Perszyk being able to function as intended to properly push/pull the occluder/implant to the desired treatment site. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
As to (ii), as stated above, the intermediate outer coil 240 has an outer diameter that approximates the inner diameter of the lumen; and as modified above, the combination would encompass or, at least, make obvious to one of ordinary skill in the art for the plurality of beads to have the same diameter as the intermediate outer coil 240 such that the plurality of beads have an outer diameter that approximates the inner diameter of the lumen as claimed.
Regarding claim 2, as discussed above, it would be obvious to modify the device of Perszyk to incorporate a plurality of beads as taught by Chin in view of Douk. Additionally, Perszyk discloses wherein the central shaft (inner member 202) includes stainless steel (paragraph [0034]).
Regarding claim 3, as discussed above, it would be obvious to modify the device of Perszyk to incorporate a plurality of beads as taught by Chin in view of Douk. Additionally, Perszyk discloses wherein the central shaft (inner member 202) includes a nickel-titanium alloy (paragraph [0034]).
Regarding claim 5, as discussed above, it would be obvious to modify the device of Perszyk to incorporate a plurality of beads as taught by Chin in view of Douk. Additionally, Perszyk discloses wherein the first region (proximal section 206) includes an outer jacket (heat shrink material 302) disposed over the first coil assembly (paragraph [0044] and Fig. 5).
Regarding claim 7, as discussed above, it would be obvious to modify the device of Perszyk to incorporate a plurality of beads as taught by Chin in view of Douk. Additionally, Perszyk discloses wherein the first coil assembly (proximal outer member 210) includes a single coil (proximal outer member 210) (Fig. 5).
Regarding claim 9, as discussed above, it would be obvious to modify the device of Perszyk to incorporate a plurality of beads as taught by Chin in view of Douk. Additionally, Perszyk discloses wherein the second coil assembly (distal outer member 208) includes two or more coils (Examiner’s note: as stated in paragraph [0059] the distal outer member 208 is a double layer coil, thus comprising two coils).
Regarding claim 12, as discussed above, it would be obvious to modify the device of Perszyk to incorporate a plurality of beads as taught by Chin in view of Douk. Additionally, Perszyk discloses wherein the first region (proximal section 206) has a first outer diameter and wherein the second region (distal section 204) has a second outer diameter different from the first outer diameter (Fig. 5).
Regarding claim 1, (alternate interpretation – changes italicized below) Perszyk discloses a delivery device (introducer assembly 100 and delivery cable 200) for an occlusive implant (medical device 201) (abstract, paragraphs [0003], [0006], [0024 – 0026], [0029 – 0030], [0054 – 0058], and Figs. 1 – 6, 12), the delivery device comprising:
a delivery sheath (delivery sheath 203) having a proximal region, a distal tip region, and a lumen formed therein (paragraphs [0006 – 0007], [0024], [0030 – 0031], [0039 – 0040], and Fig. 2);
a core wire (delivery cable 200) slidably disposed in the lumen paragraphs [0006 – 0007], [0032 – 0036], and Fig. 5, 12);
wherein the core wire (delivery cable 200) includes a central shaft (inner member 202 with core wire 406, first layer 404, and second layer 406), a first region (distal section 204) having a first coil assembly (distal outer member 208) disposed along the central shaft (inner member 202), a second region (proximal section 206) with having a second coil assembly (proximal outer member 210) disposed along the central shaft (inner member 202), and a distal implant securing region (end screw 212) (paragraphs [0036 – 0040], [0046 – 0047], [0054 – 0058], and Figs. 6, 12); and
an occlusive implant (implant 201) coupled to the distal implant securing region (paragraphs [0026], [0030], [0032], and Fig. 2);
a third coil assembly (intermediate outer member 240) disposed over the central shaft (inner member 202) for providing sufficient column strength to the core wire (paragraph [0054]) and defining an outer diameter approximately equal to an inner diameter of the lumen (paragraphs [0028], [0040], and [0058]) (Examiner’s note: the term “approximately” is defined as very close to but not equal to. As stated in paragraph [0040] the outer diameter of the distal outer member 208 is greater than 98% of the inner diameter of the delivery sheath (i.e., the diameter of the lumen), and because the outer diameter of the distal outer member 208 being within less than two percent of the inner diameter of the lumen of the delivery sheath the outer diameter of the distal outer member 208 is considered to be approximately equal to the inner diameter of the lumen. Furthermore, paragraph [0058] recites wherein the intermediate outer member 240 has the same outer diameter as the distal outer member 208. Therefore, Perszyk discloses the intermediate outer member 240 defines an outer diameter approximately equal to the inner diameter of the sheath (i.e., the lumen)).
However, Perszyk is silent regarding [claims 1, 10, and 11] (i) wherein the third coil assembly is a plurality of beads members disposed over the central shaft adjacent to the first region and/or disposed over the central shaft between the first region and the second region and (ii) wherein each of the plurality of beads members defines an outer diameter approximately equal to an inner diameter of the lumen.
As to (i), Chin teaches guidewire (which equates to the delivery wire 200 of Perszyk) for an implant delivery catheter a core wire with a central shaft (core wire 101; which equates to the inner member 202 of Perszyk) comprising one or more bead members (beads 109) disposed along the length for the purpose of imparting a desired rigidity / controllable stiffness to the core wire (core wire 101) (abstract, paragraph [0004], [0009], [0019 – 0022], [0031], and Fig. 1A/B).
Additionally, Douk teaches an angioplasty guidewire with a core wire (core wire 162; which equates to the inner member 202 of Perszyk) comprising a central shaft (core wire 162) with a distal coil assembly (stiffening spring 168) or a plurality of beads (beads 175) for stiffening the core wire (core wire 162) (abstract, col. 8 lines 1 – 20, col. 8 lines 24 – 50, and Figs. 15,16). Therefore, Douk teaches coil assemblies and bead assemblies are functionally equivalent and are interchangeable without changing the principle operation of the system.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the intermediate coil assembly of Perszyk to incorporate / be replaced by a plurality of beads, based on the teachings of Chin in view of Douk, for the purpose of being able to impart a desired rigidity to the core wire (paragraph [0023] – Chin). Additionally, it should be understood that Perszyk and Chin with the teachings of Douk are known references in the art that teach a delivery system comprising a core wire with elements / members for stiffening and/or providing the desired strength and flexibility to an inner core (abstract, paragraphs [0005 – 0007], [0024 – 0026], [0054], [0058], and Figs. 1 – Perszyk ; abstract, paragraph [0004], [0009], [0019 – 0022], [0031], and Fig. 1A/B – Chin ; abstract, col. 8 lines 1 – 20, col. 8 lines 24 – 55, and Figs. 15,16 – Douk); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one known stiffening element for another (i.e., substituting the intermediate outer coil 240 for a series of beads), and the results of the substitution would have been predictable and resulted in the modified intermediate member being able to function as intended to provide the desired rigidity / flexibility to the core member as desired and resulted in the delivery cable 200 of Perszyk being able to function as intended to properly push/pull the occluder/implant to the desired treatment site. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
As to (ii), as stated above, the intermediate outer coil 240 has an outer diameter that approximates the inner diameter of the lumen; and as modified above, the combination would encompass or, at least, make obvious to one of ordinary skill in the art for the plurality of beads to have the same diameter as the intermediate outer coil 240 such that the plurality of beads have an outer diameter that approximates the inner diameter of the lumen as claimed.
Regarding claim 2, (alternate interpretation) as discussed above, it would be obvious to modify the device of Perszyk to incorporate a plurality of beads as taught by Chin in view of Douk. Additionally, Perszyk discloses wherein the central shaft (inner member 202) includes stainless steel (paragraph [0034]).
Regarding claim 3, (alternate interpretation) as discussed above, it would be obvious to modify the device of Perszyk to incorporate a plurality of beads as taught by Chin in view of Douk. Additionally, Perszyk discloses wherein the central shaft (inner member 202) includes a nickel-titanium alloy (paragraph [0034]).
Regarding claim 4, (alternate interpretation) as discussed above, it would be obvious to modify the device of Perszyk to incorporate a plurality of beads as taught by Chin in view of Douk. Additionally, Perszyk discloses wherein the central shaft (inner member 202) includes a stainless-steel member (second layer 406) and a nickel-titanium alloy member (first layer 404) secured to the stainless-steel member (paragraph [0047]).
Regarding claim 8, (alternate interpretation) as discussed above, it would be obvious to modify the device of Perszyk to incorporate a plurality of beads as taught by Chin in view of Douk. Additionally, Perszyk discloses wherein the first coil assembly (distal outer member 208) includes two or more coils (Examiner’s note: as stated in paragraph [0059] the distal outer member 208 is a double layer coil, thus comprising two coils).
Regarding claim 13, Perszyk discloses a delivery device (introducer assembly 100 and delivery cable 200) for an occlusive implant (medical device 201) (abstract, paragraphs [0003], [0006], [0024 – 0026], [0029 – 0030], [0054 – 0058], and Figs. 1 – 5, 12), the delivery device comprising:
a delivery sheath (delivery sheath 203) having a proximal region, a distal tip region, and a lumen formed therein (paragraphs [0006 – 0007], [0024], [0030 – 0031], [0039 – 0040], and Fig. 2);
a core wire (delivery cable 200) slidably disposed in the lumen (paragraphs [0006 – 0007], [0032 – 0036], and Fig. 5) (Examiner’s note: paragraph [0007] recites “The method further includes advancing the delivery cable through the deployed delivery sheath”);
wherein the core wire (delivery cable 200) includes a central shaft (inner member 202), a first region (proximal section 206) having a first coil assembly (proximal outer member 210) disposed along the central shaft (inner member 202), a second region (distal section 204) with having spacer assembly (intermediate outer member 240 and distal outer member 208) disposed along the central shaft, and a distal implant securing region (end screw 212) (paragraphs [0036 – 0040], [0054 – 0058], and Figs. 5, 12); and
an occlusive implant (implant 201) coupled to the distal implant securing region (paragraphs [0026], [0030], [0032], and Fig. 2);
the spacer assembly comprises a third coil assembly (intermediate outer member 240) disposed over the central shaft (inner member 202) for providing sufficient column strength to the core wire (paragraph [0054]) and defining an outer diameter approximately equal to an inner diameter of the lumen (paragraphs [0028], [0040], and [0058]) (Examiner’s note: the term “approximately” is defined as very close to but not equal to. As stated in paragraph [0040] the outer diameter of the distal outer member 208 is greater than 98% of the inner diameter of the delivery sheath (i.e., the diameter of the lumen), and because the outer diameter of the distal outer member 208 being within less than two percent of the inner diameter of the lumen of the delivery sheath the outer diameter of the distal outer member 208 is considered to be approximately equal to the inner diameter of the lumen. Furthermore, paragraph [0058] recites wherein the intermediate outer member 240 has the same outer diameter as the distal outer member 208. Therefore, Perszyk discloses the intermediate outer member 240 defines an outer diameter approximately equal to the inner diameter of the sheath (i.e., the lumen)).
However, Perszyk is silent regarding (i) wherein the third coil assembly is a plurality of beads members, (ii) spaced apart from one another along the central shaft and (iii) wherein each of the plurality of beads members defines an outer diameter approximately equal to an inner diameter of the lumen.
As to (i), Chin teaches guidewire (which equates to the delivery wire 200 of Perszyk) for an implant delivery catheter a core wire with a central shaft (core wire 101; which equates to the inner member 202 of Perszyk) comprising one or more bead members (beads 109) disposed along the length for the purpose of imparting a desired rigidity / controllable stiffness to the core wire (core wire 101) (abstract, paragraph [0004], [0009], [0019 – 0022], [0031], and Fig. 1A/B).
As to (ii), and in addition to Chin, Douk teaches an angioplasty guidewire with a core wire (core wire 162; which equates to the inner member 202 of Perszyk) comprising a central shaft (core wire 162) with a distal coil assembly (stiffening spring 168) or a plurality of beads (beads 175) along the core wire for stiffening the core wire (core wire 162) (abstract, col. 8 lines 1 – 20, col. 8 lines 24 – 50, and Figs. 15,16). Furthermore, Douk teaches wherein the plurality of beads (beads 175) are spaced apart from each other along the central shaft (core wire 162) via conical bead elements 178 for the purpose of imparting complementary stiffening characteristics. Based on the above, Douk teaches stiffening coil assemblies and stiffening bead assemblies, with beads spaced apart via conical bead elements, are functionally equivalent and are interchangeable without changing the principal operation of the system.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the intermediate coil assembly of Perszyk to incorporate / be replaced by a plurality of beads, based on the teachings of Chin in view of Douk, for the purpose of being able to impart a desired rigidity to the core wire (paragraph [0023] – Chin); additionally, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the beads to be spaced apart from each other via complementary conical bead elements, based on the teachings of Douk, for the purpose of imparting complementary stiffening characteristics to the central shaft (col. 8 lines 24 – 50 of Douk). Furthermore, it should be understood that Perszyk and Chin with the teachings of Douk are known references in the art that teach a delivery system comprising a core wire with elements / members for stiffening and/or providing the desired strength and flexibility to an inner core (abstract, paragraphs [0005 – 0007], [0024 – 0026], [0054], [0058], and Figs. 1 – Perszyk ; abstract, paragraph [0004], [0009], [0019 – 0022], [0031], and Fig. 1A/B – Chin ; abstract, col. 8 lines 1 – 20, col. 8 lines 24 – 55, and Figs. 15,16 – Douk); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one known stiffening element for another (i.e., substituting the intermediate outer coil 240 for a series of beads that are spaced apart via ), and the results of the substitution would have been predictable and resulted in the modified intermediate member being able to function as intended to provide the desired rigidity / flexibility to the core member as desired and resulted in the delivery cable 200 of Perszyk being able to function as intended to properly push/pull the occluder/implant to the desired treatment site. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
As to (iii), as stated above, the intermediate outer coil 240 has an outer diameter that approximates the inner diameter of the lumen; and as modified above, the combination would encompass or, at least, make obvious to one of ordinary skill in the art for the plurality of beads and the spacer beads to have the same diameter as the intermediate outer coil 240 such that the plurality of beads and the spacer beads have an outer diameter that approximates the inner diameter of the lumen as claimed.
Regarding claim 17, as discussed above, it would be obvious to modify the device of Perszyk to incorporate a plurality of beads as taught by Chin in view of Douk. Additionally, Perszyk discloses wherein the central shaft (inner member 202) includes stainless steel (paragraph [0034])
Regarding claim 13, (alternate interpretation – changes italicized below) Perszyk discloses a delivery device (introducer assembly 100 and delivery cable 200) for an occlusive implant (medical device 201) (abstract, paragraphs [0003], [0006], [0024 – 0026], [0029 – 0030], [0054 – 0058], and Figs. 1 – 6), the delivery device comprising:
a delivery sheath (delivery sheath 203) having a proximal region, a distal tip region, and a lumen formed therein (paragraphs [0006 – 0007], [0024], [0030 – 0031], [0039 – 0040], and Fig. 2);
a core wire (delivery cable 200) slidably disposed in the lumen (paragraphs [0006 – 0007], [0032 – 0036], and Fig. 5) (Examiner’s note: paragraph [0007] recites “The method further includes advancing the delivery cable through the deployed delivery sheath”);
wherein the core wire (delivery cable 200) includes a central shaft (inner member 202 with core wire 406, first layer 404, and second layer 406), a first region (proximal section 206) having a first coil assembly (proximal outer member 210) disposed along the central shaft (inner member 202), a second region (distal section 204) with having spacer assembly (intermediate outer member 240 distal outer member 208) disposed along the central shaft, and a distal implant securing region (end screw 212) (paragraphs [0036 – 0040], [0054 – 0058], and Fig. 6, 12); and
an occlusive implant (implant 201) coupled to the distal implant securing region (paragraphs [0026], [0030], [0032], and Fig. 2);
the spacer assembly comprises a third coil assembly (intermediate outer member 240) disposed over the central shaft (inner member 202) for providing sufficient column strength to the core wire (paragraph [0054]) and defining an outer diameter approximately equal to an inner diameter of the lumen (paragraphs [0028], [0040], and [0058]) (Examiner’s note: the term “approximately” is defined as very close to but not equal to. As stated in paragraph [0040] the outer diameter of the distal outer member 208 is greater than 98% of the inner diameter of the delivery sheath (i.e., the diameter of the lumen), and because the outer diameter of the distal outer member 208 being within less than two percent of the inner diameter of the lumen of the delivery sheath the outer diameter of the distal outer member 208 is considered to be approximately equal to the inner diameter of the lumen. Furthermore, paragraph [0058] recites wherein the intermediate outer member 240 has the same outer diameter as the distal outer member 208. Therefore, Perszyk discloses the intermediate outer member 240 defines an outer diameter approximately equal to the inner diameter of the sheath (i.e., the lumen)).
However, Perszyk is silent regarding (i) wherein the third coil assembly is a plurality of beads members, (ii) spaced apart from one another along the central shaft and (iii) wherein each of the plurality of beads members defines an outer diameter approximately equal to an inner diameter of the lumen.
As to (i), Chin teaches guidewire (which equates to the delivery wire 200 of Perszyk) for an implant delivery catheter a core wire with a central shaft (core wire 101; which equates to the inner member 202 of Perszyk) comprising one or more bead members (beads 109) disposed along the length for the purpose of imparting a desired rigidity / controllable stiffness to the core wire (core wire 101) (abstract, paragraph [0004], [0009], [0019 – 0022], [0031], and Fig. 1A/B).
As to (ii), and in addition to Chin, Douk teaches an angioplasty guidewire with a core wire (core wire 162; which equates to the inner member 202 of Perszyk) comprising a central shaft (core wire 162) with a distal coil assembly (stiffening spring 168) or a plurality of beads (beads 175) along the core wire for stiffening the core wire (core wire 162) (abstract, col. 8 lines 1 – 20, col. 8 lines 24 – 50, and Figs. 15,16). Furthermore, Douk teaches wherein the plurality of beads (beads 175) are spaced apart from each other along the central shaft (core wire 162) via conical bead elements 178 for the purpose of imparting complementary stiffening characteristics. Based on the above, Douk teaches stiffening coil assemblies and stiffening bead assemblies, with beads spaced apart via conical bead elements, are functionally equivalent and are interchangeable without changing the principal operation of the system.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the intermediate coil assembly of Perszyk to incorporate / be replaced by a plurality of beads, based on the teachings of Chin in view of Douk, for the purpose of being able to impart a desired rigidity to the core wire (paragraph [0023] – Chin); additionally, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the beads to be spaced apart from each other via complementary conical bead elements, based on the teachings of Douk, for the purpose of imparting complementary stiffening characteristics to the central shaft (col. 8 lines 24 – 50 of Douk). Furthermore, it should be understood that Perszyk and Chin with the teachings of Douk are known references in the art that teach a delivery system comprising a core wire with elements / members for stiffening and/or providing the desired strength and flexibility to an inner core (abstract, paragraphs [0005 – 0007], [0024 – 0026], [0054], [0058], and Figs. 1 – Perszyk ; abstract, paragraph [0004], [0009], [0019 – 0022], [0031], and Fig. 1A/B – Chin ; abstract, col. 8 lines 1 – 20, col. 8 lines 24 – 55, and Figs. 15,16 – Douk); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one known stiffening element for another (i.e., substituting the intermediate outer coil 240 for a series of beads that are spaced apart via ), and the results of the substitution would have been predictable and resulted in the modified intermediate member being able to function as intended to provide the desired rigidity / flexibility to the core member as desired and resulted in the delivery cable 200 of Perszyk being able to function as intended to properly push/pull the occluder/implant to the desired treatment site. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
As to (iii), as stated above, the intermediate outer coil 240 has an outer diameter that approximates the inner diameter of the lumen; and as modified above, the combination would encompass or, at least, make obvious to one of ordinary skill in the art for the plurality of beads and the spacer beads to have the same diameter as the intermediate outer coil 240 such that the plurality of beads and the spacer beads have an outer diameter that approximates the inner diameter of the lumen as claimed.
Regarding claim 18, (alternate interpretation) as discussed above, it would be obvious to modify the device of Perszyk to incorporate a plurality of beads as taught by Chin in view of Douk. Additionally, Perszyk discloses wherein the central shaft (inner member 202) includes a stainless-steel member (second layer 406) and a nickel-titanium alloy member (first layer 404) secured to the stainless-steel member (paragraph [0047]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Perszyk et al (US 2018/0235658 A1) (previously cited) in view of Chin et al (US 2012/0191012 A1) (previously cited) and Douk et al (US 6,183,420 B1) (previously cited), as applied to claim 1 above, and further in view of Kajima (US 5,554,139) (previously cited).
Regarding claim 6, as discussed above, the combination of Perszyk, Chin, and Douk teaches the delivery device of claim 1.
However, the combination of Perszyk, Chin, and Douk is silent regarding (i) wherein the first region includes a braid coupled to the first coil assembly.
As to the above, Kajima teaches a medical device comprising a sheath (guiding catheter 9) and a core wire (catheter 1; which equates to the delivery cable 200 of Perszyk) extending through the sheath (abstract, col. 12 lines 50 – 63, col. 21 lines 10 – 25 and Figs. 1,3,8) comprising the core wire comprising a central shaft (inner layer 6; which equates to the inner member 202 of Perszyk), a first region (main body portion 2; which equates to the proximal region 206 of Perszyk) with a first coil assembly (coil 8; which equates to the proximal outer coil 210) and wherein the first region includes a braid (metal braid layer 30) for the purpose of restricting possible deformation of the coil (col. 7 lines 52 – 54 and col. 16 lines 53 – 65).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, based on the teachings of Kajima, to modify the first region of Perszyk in view of Chin and Douk to incorporate a braid attached to the first coil assembly for the purpose of restricting possible deformation of the coil (col. 7 lines 52 – 54 – Kajima).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over as Perszyk et al (US 2018/0235658 A1) (previously cited) and in view of Larsen et al (US 2014/0142617 A1) (previously cited), Chin et al (US 2012/0191012 A1) (previously cited), and Douk et al (US 6,183,420 B1) (previously cited).
Regarding claim 20, Perszyk discloses a method for implanting an occlusive implant (occluder / medical device 201) (abstract, paragraphs [0003], [0006], [0024 – 0026], [0029 – 0030], [0054 – 0058], and Figs. 1 – 5, 8, 12) to a treatment site, the method comprising:
advancing a delivery device (introducer assembly 100 and delivery cable 200) to a position adjacent to a treatment site (paragraphs [0024] and [0050]), the delivery device comprising:
a delivery sheath (delivery sheath 203) having a proximal region, a distal tip region, and a lumen formed therein (paragraphs [0006 – 0007], [0024], [0030 – 0031], [0039 – 0040], and Fig. 2);
a core wire (delivery cable 200) slidably disposed in the lumen paragraphs [0006 – 0007], [0032 – 0036], and Fig. 5,12);
wherein the core wire (delivery cable 200) includes a central shaft (inner member 202), a first region (proximal section 206) having a first coil assembly (proximal outer member 210) disposed along the central shaft (inner member 202), a second region (distal section 204) having a second coil assembly (intermediate outer member 240) disposed along the central shaft, and a distal implant securing region (end screw 212) (paragraphs [0036 – 0040], [0055], and Fig. 12); and
an occlusive implant (implant 201) coupled to the distal implant securing region (paragraphs [0026], [0030], [0032], and Fig. 2); and
advancing the core wire (delivery cable 200) such that the occlusive implant (implant 201) advances out from the distal tip region of the delivery sheath (paragraph [0050] and Fig. 8);
the second coil assembly (intermediate outer member 240) disposed over the central shaft (inner member 202) for providing sufficient column strength to the core wire (paragraph [0054]) and defining an outer diameter approximately equal to an inner diameter of the lumen (paragraphs [0028], [0040], and [0058]) (Examiner’s note: the term “approximately” is defined as very close to but not equal to. As stated in paragraph [0040] the outer diameter of the distal outer member 208 is greater than 98% of the inner diameter of the delivery sheath (i.e., the diameter of the lumen), and because the outer diameter of the distal outer member 208 being within less than two percent of the inner diameter of the lumen of the delivery sheath the outer diameter of the distal outer member 208 is considered to be approximately equal to the inner diameter of the lumen. Furthermore, paragraph [0058] recites wherein the intermediate outer member 240 has the same outer diameter as the distal outer member 208. Therefore, Perszyk discloses the intermediate outer member 240 defines an outer diameter approximately equal to the inner diameter of the sheath (i.e., the lumen)).
However, Perszyk is silent regarding (i) wherein the implant is a left atrial appendage occlusive implant, wherein the method is for implanting the occlusive implant into the left atrial appendage, (ii) wherein the second region is a plurality of beads members, and (iii) defining an outer diameter approximately equal to an inner diameter of the lumen.
As to (i), Larsen teaches, in the same field of endeavor, a method of implanting an occlusive implant (occlusive device 100) into a left atrial appendage comprising advancing a delivery device (delivery sheath 168 and delivery catheter 170) to a position adjacent to the left atrial appendage, the delivery device comprising a sheath (sheath 168) and a core wire (delivery catheter 170; which equates to the delivery cable 200 of Perszyk), and advancing the core wire (delivery catheter 170) such that the occlusive implant (occlusive device 100) advances out from the delivery sheath (sheath 168) for the purpose of treating thrombus formation in the LAA of arrhythmic patients (abstract, paragraphs [0004], [0064], [0066 – 0067], and Figs. 1,6).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system to include a LAA occlusive implant and modify the method of Perszyk to incorporate the step of placing the LAA occlusive implant to/into the LAA, as taught by Larsen, for purpose of treating thrombus formation in the LAA of arrhythmic patients (paragraph [0004] – Larsen).
As to (ii), Chin teaches guidewire (which equates to the delivery wire 200 of Perszyk) for an implant delivery catheter a core wire with a central shaft (core wire 101; which equates to the inner member 202 of Perszyk) comprising one or more bead members (beads 109) disposed along the length for the purpose of imparting a desired rigidity / controllable stiffness to the core wire (core wire 101) (abstract, paragraph [0004], [0009], [0019 – 0022], [0031], and Fig. 1A/B).
Additionally, Douk teaches an angioplasty guidewire with a core wire (core wire 162; which equates to the inner member 202 of Perszyk) comprising a central shaft (core wire 162) with a distal coil assembly (stiffening spring 168) or a plurality of beads (beads 175) for stiffening the core wire (core wire 162) (abstract, col. 8 lines 1 – 20, col. 8 lines 24 – 50, and Figs. 15,16). Therefore, Douk teaches coil assemblies and bead assemblies are functionally equivalent and are interchangeable without changing the principal operation of the system.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the intermediate coil assembly of Perszyk to incorporate / be replaced by a plurality of beads, based on the teachings of Chin in view of Douk, for the purpose of being able to impart a desired rigidity to the core wire (paragraph [0023] – Chin). Additionally, it should be understood that Perszyk and Chin with the teachings of Douk are known references in the art that teach a delivery system comprising a core wire with elements / members for stiffening and/or providing the desired strength and flexibility to an inner core (abstract, paragraphs [0005 – 0007], [0024 – 0026], [0054], [0058], and Figs. 1 – Perszyk ; abstract, paragraph [0004], [0009], [0019 – 0022], [0031], and Fig. 1A/B – Chin ; abstract, col. 8 lines 1 – 20, col. 8 lines 24 – 55, and Figs. 15,16 – Douk); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one known stiffening element for another (i.e., substituting the intermediate outer coil 240 for a series of beads), and the results of the substitution would have been predictable and resulted in the modified intermediate member being able to function as intended to provide the desired rigidity / flexibility to the core member as desired and resulted in the delivery cable 200 of Perszyk being able to function as intended to properly push/pull the occluder/implant to the desired treatment site. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
As to (iii), as stated above, the intermediate outer coil 240 has an outer diameter that approximates the inner diameter of the lumen; and as modified above, the combination would encompass or, at least, make obvious to one of ordinary skill in the art for the plurality of beads to have the same diameter as the intermediate outer coil 240 such that the plurality of beads have an outer diameter that approximates the inner diameter of the lumen as claimed.
Response to Arguments
Applicant's arguments, filed 08/13/2026, with respect to claims 1, 13, and under Perszyk, Chin, and Douk, have been fully considered but they are not persuasive. More specifically:
With respect to Applicant’s argument that “The rejection assumes that a series of discrete bead members and a lumen-approximating coil are interchangeable in this respect. They are not. In fact, the very references from which the Office draws the bead members (Chin and Douk) disclose beads that are necessarily smaller than, and free to move within, a surrounding structure. Perszyk's coil teaching therefore cannot be transplanted onto the claimed bead members to supply the diameter limitation”, the Examiner notes that as stated in the rejection above, the Examiner gives motivation as to why one of ordinary skill would be motivated to incorporate a plurality of beads into the device of Perszyk, and further explains, via the teachings of Douk, wherein a stiffening coil (similar to the intermediate coil 240 of Perszyk) and a stiffening string of beads (similar to the beads of Chin) are functional equivalents that are interchangeable wherein the system would operate as intended with either a coil or a plurality of beads. Furthermore, the moveability of the beads does not render the modified device as inoperable, the Examiner contends the moveability of beads gives the modified device the ability to further vary the stiffness of the system as the beads can be compressed together or placed in a more relaxed state based on the needs of the operator. Lastly, the Examiner is not relying on the ‘size’ of the beads in either of Chin or Douk, the Examiner is only relying on the structure and function of a plurality of beads for incorporating the ability to a variable stiffness along the core wire; Perszyk discloses the intermediate coil member 240 having the claimed diameter, and because the intermediate coil member 240 is modified to be the plurality of beads, it would be well within the purview of one of ordinary skill in the art to make the plurality of beads to the same diameter as the intermediate coil member 240 as they are being placed in the same location and serve a similar purpose. Therefore, the prior art combination encompasses or, at least, makes obvious having the plurality of beads with the claimed outer diameter. Therefore, Applicant’s argument is not persuasive.
With respect to Applicant’s argument that “Additionally, Perszyk's coil teaching is directed to a different location on the core wire than the claimed bead members. Perszyk's teaching that an outer member approximates the lumen concerns the distal outer member 208, near the distal end of the delivery cable, and its stated purpose-reducing the force necessary to advance the device-is tied to that distal spacer. (Perszyk [0028], [0040].) The bead members of claim 1, by contrast, are an element in addition to both the first coil assembly and the second coil assembly and, as the Office itself characterizes the proposed modification, are located in the intermediate region of the core wire, "adjacent to the first (proximal) region and in between the first (proximal) region and the second (distal) region." (Office Action paragraph 25.) Perszyk provides no teaching, suggestion, or reason to size an intermediate stiffening element to approximate the inner diameter of the lumen.” and “So located, however, the beads cannot satisfy the diameter limitation of claim 1, which requires that each bead member defines an outer diameter approximately equal to the inner diameter of the lumen. Perszyk does not teach that the intermediate outer member 240 approximates the inner diameter of the lumen. Perszyk confines its lumen- approximating teaching to the distal outer member 208”, as stated in the rejection above, the intermediate coil member 240 is disclosed, by Perszyk, as having the same outer diameter as the distal coil member 208 and the distal coil member 208 is disclosed as having an outer diameter that approximates the inner diameter of the lumen, thus the intermediate coil member 240 also has an outer diameter that approximates the inner diameter of the lumen. Therefore, Perszyk does provide the teachings as to the outer diameter of the intermediate stiffening element (i.e., the intermediate coil member 240) approximating the inner diameter of the lumen. Thus, Applicant’s arguments are not persuasive.
With respect to Applicant’s argument that “the Advisory Action dated July 23, 2026 attempts to supply the missing link by citing Perszyk paragraph [0058] for the proposition that "the intermediate outer member 240 has the same diameter as the distal outer member 208." Paragraph [0058] of Perszyk does not say this. It states that the distal inner member, proximal inner member, and intermediate inner member, as well as the distal outer member 208, proximal outer member 210, and intermediate outer member 240, "may have the same or different diameters from one another allowing for each component to be individually sized and configured to allow for the specifically desired strength and flexibility thereof. That is a disclosure of two design options, not a teaching that steers a person of ordinary skill toward the "same diameter" option - and certainly not toward selecting that option in order to approximate the inner diameter of the lumen.”, the Perszyk gives both options, and both options would steer a person of ordinary skill in the art towards either option; it is up to one of ordinary skill in the art to choose which option most benefits them at the time of choosing. Disclosing both options as “options” does not preclude one or the other from being relied upon by the Examiner, as each option is its own embodiment of the disclosed system. Thus, Applicant’s arguments are not persuasive.
With respect to Applicant’s argument that “Substituting Chin's or Douk's shiftable, sub- lumen stiffening beads for Perszyk's coil and then enlarging them to approximate the lumen does not preserve their function; it changes their principle of operation and renders them unsatisfactory for their intended purpose of providing variable, controllable stiffness. A proposed modification that changes a reference's principle of operation, or that renders the reference unsatisfactory for its intended purpose, does not support a conclusion of obviousness. See MPEP § 2143.01(V)-(VI). The combination is therefore improper independent of the missing limitation.” , “Douk expressly discloses that its beads are carried coaxially within, and are surrounded by, an outer spring, such that the beads are necessarily smaller in outer diameter than the outer spring” , and “The record itself- through Douk's explicit structural teaching and Chin's admitted silence - establishes that the beads relied upon are taught as, and remain sub-lumen stiffening elements, not lumen-approximating spacers”, there is nothing within the system of Perszyk that would preclude or prevent the beads of the modified device from operating as intended; additionally, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Moreover, the Examiner is relying on Douk to show that a coil and a plurality of beads, within the art, are functional equivalents that can be interchanged, and that it is known within the art to substitute the intermediate coil member 240 for a plurality of beads and still maintain the principle operation of the device. The specific location and relative size of the beads of Douk have no bearing on the modification since the specific beads of Douk are not being brought into system of Perszyk. Lastly, the Examiner notes that “sub-lumen stiffening elements” is equal to “lumen approximating spacers” as “sub lumen” encompasses “lumen approximating” because both only require the outer diameter to be less than the inner diameter of the lumen. Thus, Applicant’s arguments are not persuasive.
Conclusion
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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