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 .
Election/Restrictions
Claims 33 and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/27/2026.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 7-10, 13, 16, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hossainy et al. US 20150265438 A1, herein referred to as Hossainy.
Regarding claim 1, Hossainy discloses an endovascular scaffold (Fig 7, scaffolds 20, 40, or 60) for use in a peripheral vessel [0141], comprising: a plurality of undulating rings (Fig 5A, 44a-d undulating); and a plurality of interconnecting struts (Fig 5A, struts 43) connecting the plurality of undulating rings to one another (Fig 5A; [0119]), wherein the plurality of undulating rings are radially compressible into a delivery configuration and expandable from the delivery configuration to an expanded configuration when deployed (FIG. 7, [0137]: The scaffold is crimped to the balloon by a crimping process"), and wherein at least some of the interconnecting struts are configured to biodegrade over a degradation period after the endovascular scaffold is deployed within the peripheral vessel ([0199-0200]).
Regarding claim 7, Hossainy discloses wherein each of the plurality of interconnecting struts is positioned between adjacent undulating rings (Hossainy Fig 5A).
Regarding claim 8, Hossainy discloses wherein at least one of the plurality of interconnecting struts has a width which is less than a circumference of at least one of the plurality of undulating rings (Hossainy [0052] ”a strut width for rings of the frustum ranges between about 50 microns and 150 microns”; [0113] Table 2 DM40: 3-5 mm; Fig 5B. DM40 (1 ring).
Regarding claim 9, Hossainy discloses wherein the plurality of undulating rings are biodegradable (Hossainy [0199-0200]).
Regarding claim 10, Hossainy discloses wherein the plurality of undulating rings are configured to biodegrade at a slower rate than the plurality of interconnecting struts ([0182]).
Regarding claim 13, Hossainy discloses wherein at least one of the plurality of interconnecting struts is formed by electrospinning (Hossainy [0155] polyurethane is electro-spun material).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hosssainy in view of Calisse US 20170020701 A1, herein referred to as Calisse.
Regarding claim 15, Hossainy discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein at least one of the plurality of interconnecting struts is comprised of a plurality of a filament (Hossainy [0113]; PGA).
But Hossainy does not disclose wherein the filaments [are] in a multifilament configuration.
But Calisse teaches struts (Fig 2b, 28): wherein the filaments [are] in a multifilament configuration ([0064]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hossainy to incorporate wherein the filaments [are] in a multifilament configuration, as taught and suggested by Calisse, in order to allow long term patency of the implant (Calisse [0038]).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hossainy in view of Kantor et al. US 20040172127 A1, herein referred to as Kantor.
Regarding claim 2, Hossainy discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose at least one of the plurality of interconnecting struts comprises growth factors disposed thereon or integrated therein.
But Kantor teaches wherein at least one of the plurality of interconnecting struts comprises growth factors disposed thereon or integrated therein ([0026-0027]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hossainy to incorporate at least one of the plurality of interconnecting struts comprises growth factors disposed thereon or integrated therein as taught and suggested by Kantor in order to allow growth factor to target site (Kantor [0026]).
Regarding claim 3, Hossainy discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose wherein the growth factors comprise at least one of a vascular endothelial growth factor (VEGF), a platelet-derived growth factor (PDGF), and a heparin-binding EGF-like growth factor (HB-EGF).
But Kantor teaches a plurality of struts (Fig 1, 10) wherein the growth factors comprise at least one of a vascular endothelial growth factor (VEGF), a platelet-derived growth factor (PDGF) ([0027]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hossainy to incorporate wherein the growth factors comprise at least one of a vascular endothelial growth factor (VEGF), a platelet-derived growth factor (PDGF), as taught and suggested by Kantor in order to allow growth factor to target site (Kantor [0026]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hossainy in view of Kantor, and further in view of Sirhan et al. US 20180200091 A1, herein referred to as Sirhan.
Regarding claim 4, Hossainy/Kantor discloses the invention substantially as claimed and as discussed above with respect to claim 3, and additionally teaches wherein the recessed surface is configured to contain at least some of the growth factors (Kantor [0026-0027]), but does not discloses wherein at least one of the plurality of interconnecting struts comprises a recessed surface defined along the at least one interconnecting strut.
But Sirhan teaches wherein at least one of the plurality of interconnecting struts (Fig 16H-1, 160) comprises a recessed surface (Sirhan Fig 16H-1, 166) defined along the at least one interconnecting strut (Sirhan Fig 16H-1).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hossainy/Kantor to incorporate wherein at least one of the plurality of interconnecting struts comprises a recessed surface defined along the at least one interconnecting strut, as taught and suggested by Sirhan in order to stabilize the implant (Sirhan [1293]).
Claim(s) 5, 6, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hossainy in view of Sirhan et al. US 20180200091 A1, herein referred to as Sirhan.
Regarding claim 5, Hossainy discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose wherein at least one of the plurality of interconnecting struts is made in part of chitin, chitosan, or a combination thereof.
But Sirhan teaches wherein at least one of the plurality of interconnecting struts (Fig 4A 21; [0230]) is made in part of chitin, chitosan, or a combination thereof ([0229]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hossainy to incorporate wherein at least one of the plurality of interconnecting struts is made in part of chitin, chitosan, or a combination thereof, as taught and suggested by Sirhan in order adjust implant degradation rate (Sirhan [0229]).
Regarding claim 6, Hossainy/Sirhan discloses the invention substantially as claimed and as discussed above with respect to claim 5 teaches wherein the degradation period is between about 7 months and 24 months (Sirhan [0043]).
Regarding claim 11, Hossainy/Sirhan discloses the invention substantially as claimed and as discussed above with respect to claim 5 teaches wherein the plurality of undulating rings are configured to biodegrade between about 3.0 years and 10.0 years after deployment within the peripheral vessel (Sihran [0147]).
Claim(s) 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hossainy in view of Pandelidis et al. US 20110319977 A1, herein referred to as Pandelidis.
Regarding claim 12, Hossainy discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose wherein the undulating rings deployed within the peripheral vessel are supported in part by an extracellular matrix formed at discontinuities developed in between the undulating rings as the interconnecting struts biodegrade.
But Pandelidis teaches wherein the undulating rings deployed within the peripheral vessel are supported in part by an extracellular matrix ([0006]) formed at discontinuities developed in between the undulating rings as the interconnecting struts biodegrade (capable of forming in place as claimed).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hossainy to incorporate wherein the undulating rings deployed within the peripheral vessel are supported in part by an extracellular matrix formed at discontinuities developed in between the undulating rings as the interconnecting struts biodegrade, as taught and suggested by Pandelidis in order to allow the scaffold to corporate with restenosis (Pandelidis [0006]).
Regarding claim 14, Hossainy/ Pandelidis discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein at least one of the plurality of interconnecting struts is comprised of a monofilament (Pandelidis [0115]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hosssainy in view of Papp et al. US 20140046431 A1, herein referred to as Papp.
Regarding claim 16, Hossainy discloses a balloon-scaffold (Fig 7, scaffolds 20, 40, or 60 and 100) assembly for use in a peripheral vessel ([0141]), comprising: an inflatable balloon (Fig 7, 102) of a balloon catheter (Fig 7, 100), and an endovascular scaffold crimped onto the inflatable balloon in a delivery configuration (Fig 7, crimped configuration [0137]), wherein the endovascular scaffold comprises: a plurality of undulating rings (Fig 5A, 44a-d undulating), and a plurality of interconnecting struts (Fig 5A, struts 43) connecting the plurality of undulating rings to one another (Fig 5A; [0119]), and wherein the inflatable balloon provides structural support to the endovascular scaffold during delivery ([0137]).
But does not explicitly disclose wherein the inflatable balloon is expandable to a minimum diameter of about 2.9 mm at about 6.0 ATMs of pressure and expandable to a maximum diameter of about 3.7 mm at about 16.0 ATMs of pressure, wherein the inflatable balloon is also characterized by an upward sloping compliance curve; and wherein portions of the inflatable balloon extend through void spaces in between the plurality of undulating rings when the plurality of undulating rings are radially compressed into the delivery configuration.
Papp teaches wherein the inflatable balloon (Fig 5, 350) is expandable to a minimum diameter of about 2.9 mm at about 6.0 ATMs ([0098] balloon taught to be made of PEBAX; fully capable of being inflated as recited; instant application [0097] teaches using polyamide to make up ballon) of pressure and expandable to a maximum diameter of about 3.7 mm at about 16.0 ATMs of pressure ([0098] balloon taught to be made of Pebax; fully capable of being inflated as recited; instant application [0097] teaches using polyamide to make up ballon), wherein the inflatable balloon is also characterized by an upward sloping compliance curve ([0041] balloon taught to be made of elastomers such as Pebax; fully capable; instant application [0097] teaches using elastomers such polyamide and Pebax to make up ballon); and wherein portions of the inflatable balloon extend through void spaces in between the plurality of undulating rings when the plurality of undulating rings are radially compressed into the delivery configuration ([0098] balloon taught to be made of elastomers such as Pebax; fully capable; instant application [0097] teaches using polyamide to make up ballon),
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the base invention of Hossainy to incorporate wherein the inflatable balloon is expandable to a minimum diameter of about 2.9 mm at about 6.0 ATMs of pressure and expandable to a maximum diameter of about 3.7 mm at about 16.0 ATMs of pressure, wherein the inflatable balloon is also characterized by an upward sloping compliance curve); and wherein portions of the inflatable balloon extend through void spaces in between the plurality of undulating rings when the plurality of undulating rings are radially compressed into the delivery configuration, as taught and suggested by Papp in order to provide the correct compliance of the balloon element (Papp [0098])
Claim(s) 67-68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hosssainy in view of Papp, in view of Kantor.
Regarding claim 67, Hossainy/Papp discloses the invention substantially as claimed and as discussed above with respect to claim 16, but does not disclose wherein at least one of the plurality of interconnecting struts comprises growth factors disposed thereon or integrated therein, and wherein the growth factors comprise at least one of a vascular endothelial growth factor (VEGF), a platelet-derived growth factor (PDGF).
But Kantor teaches wherein at least one of the plurality of interconnecting struts comprises growth factors (Kantor [0026-0027]) disposed thereon or integrated therein, and wherein the growth factors comprise at least one of a vascular endothelial growth factor (VEGF), a platelet-derived growth factor (PDGF) (Kantor [0026-0027]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hossainy to incorporate wherein the growth factors comprise at least one of a vascular endothelial growth factor (VEGF), a platelet-derived growth factor (PDGF), as taught and suggested by Kantor in order to allow growth factor to target site (Kantor [0026]).
Regarding claim 68, Hossainy/Papp/Kantor discloses the invention substantially as claimed and as discussed above with respect to claim 4 teaches wherein at least one of the plurality of interconnecting struts comprises a recessed surface (Sirhan Fig 16H-1, 166) defined along the at least one interconnecting strut (Sirhan Fig 16H-1), and wherein the recessed surface is configured to contain at least some of the growth factors (Kantor [0026-0027]).
Claim(s) 69-70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hosssainy in view of Papp, in view of Kantor.
Regarding claim 69, Hossainy/Papp discloses the invention substantially as claimed and as discussed above with respect to claim 16, but does not disclose wherein at least one of the plurality of interconnecting struts is made in part of chitin, chitosan, or a combination thereof.
But Sirihan teaches wherein at least one of the plurality of interconnecting struts (Sirhan Fig 4A 21; [0230]) is made in part of chitin, chitosan, or a combination thereof (Sirhan Fig 4A 21; [0229-0230].
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hossainy to incorporate wherein at least one of the plurality of interconnecting struts is made in part of chitin, chitosan, or a combination thereof, as taught and suggested by Sirhan in order adjust implant degradation rate (Sirhan [0229]).
Regarding claim 70, Hossainy/Sirhan discloses the invention substantially as claimed and as discussed above with respect to claim 69 teaches wherein at least some of the interconnecting struts are configured to biodegrade over a degradation period after the endovascular scaffold is deployed within the peripheral vessel, and wherein the degradation period is between about 7 months and 24 months (Sirhan [0043]).
Conclusion
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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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