DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Claims 1 and 2 are pending in the application. Claim 1 has been amended.
Claim Rejections - 35 USC § 103
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 1 and 2 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chaisson et al. (US 5,665,116) (“Chaisson”) in view of Rhodes (US 5,593,417).
Regarding claim 1, Chaisson discloses (Figures 1A-17) a method of treating atherosclerotic occlusive disease, comprising: treating a plaque dissection (21) after balloon angioplasty (Figures 2A-6) by installing a tack device (25/45) formed as a thin, annular band (Figures 10 and 12) of durable, flexible material (Column 5, lines 35-47; Column 6, lines 16-30) applied with an expansion force to hold the plaque dissection (21) at an applied site of said band against a blood vessel wall (Figures 10 and 12), and wherein said annular band includes a continuous surface (28/49) that is continuously disposed in a plane substantially perpendicular to the axial direction (Figures 10 and 12).
However, Chaisson fails to disclose a plurality of barbs or anchoring elements on an outer annular periphery of the band, said annular band and plurality of barbs or anchoring elements being dimensioned and designed to apply point pressure at the plurality of barbs or anchoring elements and reduce pressure against the blood vessel wall at other portions of the annular band, wherein the plurality of barbs or anchoring elements have a dimension in an axial direction that is less than the width of the annular band in the axial direction.
In the same field of endeavor, Rhodes teaches (Figures 1-8) a method of treating atherosclerotic occlusive disease, comprising: treating a plaque dissection (10) after balloon angioplasty (Column 1, lines 11-34) by installing a tack device (26) formed as a thin, annular band of durable, flexible material (Column 6, lines 27-43) having a plurality of barbs or anchoring elements (40/70) on an outer annular periphery of the band (Figures 2-5, 7, 8), and applied with an expansion force to hold the plaque dissection at an applied site of said band against a blood vessel wall, said annular band and plurality of barbs being dimensioned and designed to apply point pressure at the barbs (Column 4, lines 26-39; Figures 1 and 4 show that the barbs 40 penetrate the lesion 10) and reduce pressure against the blood vessel wall at other portions of the annular band (other portions of the band are not barbed and do not penetrate into the lesion), wherein the plurality of barbs (40/70) have a dimension in an axial direction that is less than the width of the annular band in the axial direction (Figures 2-5, 7, and 8), and wherein said annular band is continuously disposed in a plane substantially perpendicular to the axial direction (see Figure 1 annotated below). Rhodes teaches that each tack device (26) comprises a plurality of interconnected links (80). Each of the links is an elongated rigid member formed of stainless steel or some other suitable biocompatible material, e.g., tantalum, plastic. Each link has a pair of ends and is joined to an associated link via a pivotable joint (82). Each joint (32) is made up of one end of one link and the other end of the immediately adjacent link (column 6, lines 25-32). Each tack is a continuous ring, perpendicular to the axial direction, formed of interconnected links.
PNG
media_image1.png
261
330
media_image1.png
Greyscale
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the outer periphery of the annular band disclosed by Chaisson to include a plurality of barbs or anchoring elements, wherein said annular band and said plurality of barbs or anchoring elements are dimensioned and designed to apply point pressure at the plurality of barbs or anchoring elements and reduce pressure against the blood vessel wall at other portions of the annular band, wherein the plurality of barbs or anchoring elements have a dimension in an axial direction that is less than the width of the annular band in the axial direction, as taught by Rhodes. This modification would allow the annular band to tightly engage, e.g., burrow slightly into, the interior of the vessel, duct, or lumen to fixedly secure the device in place (Rhodes, Column 7, lines 29-31).
Regarding claim 2, Chaisson discloses (Figures 1A-17) a device (25/45) for holding plaque (20, 21) against a blood vessel wall (10) in treating atherosclerotic occlusive disease, said blood vessel wall (10) having an axial direction (11), comprising: a thin, annular band (Figures 10 and 12) of durable, flexible material (Column 5, lines 35-47; Column 6, lines 16-30) having an outer periphery and adjoining struts (30, 31/53, 54), and wherein said annular band includes a continuous surface (28/49) that is continuously disposed in a plane substantially perpendicular to the axial direction (Figures 10 and 12).
However, Chaisson fails to disclose a plurality of focal elevating elements disposed on said outer annular periphery, said focal elevating elements each having an axial dimension that is substantially parallel with the blood vessel wall axial direction that is equal to or less than a width of an adjoining strut of said annular band on which said focal elevating elements are disposed, said focal elevating elements being configured to reduce regional areas of contact of the device with the blood vessel wall, said annular band being dimensioned and designed to apply point pressure and elevate adjoining struts forming the thin annular band of the device off from contact with the blood vessel wall.
In the same field of endeavor, Rhodes teaches (Figures 1-8) a device for holding plaque (10) against a blood vessel wall (12) in treating atherosclerotic occlusive disease, said blood vessel wall having an axial direction (46), comprising: a thin, annular band (26) of durable, flexible material (Column 6, lines 27-43) having an outer periphery and a plurality of focal elevating elements (40/70) disposed on said outer annular periphery (Figures 2-5, 7, 8), said focal elevating elements each having an axial dimension that is substantially parallel with the blood vessel wall axial direction (Figures 4 and 8) that is equal to or less than a width of an adjoining strut of said annular band on which said focal elevating elements are disposed (Figures 2-5, 7, 8), said focal elevating elements being capable of reducing regional areas of contact of the device with the blood vessel wall (12), said annular band being dimensioned and designed to apply point pressure (Column 4, lines 26-39) and elevate adjoining struts (30) forming the thin annular band of the device off from contact with the blood vessel wall (12). Figures 1 and 4 show that said focal elevating elements (40) apply point pressure by penetrating into the lesion (10) and elevate the adjoining struts (30) off from contact with the blood vessel wall (12), and wherein said annular band is continuously disposed in a plane substantially perpendicular to the axial direction (see Figure 1 annotated below). Rhodes discloses that each tack device (26) comprises a plurality of interconnected links (30). Each of the links is an elongated rigid member formed of stainless steel or some other suitable biocompatible material, e.g., tantalum, plastic. Each link has a pair of ends and is joined to an associated link via a pivotable joint (32). Each joint (32) is made up of one end of one link and the other end of the immediately adjacent link (column 6, lines 25-32). Each tack is a continuous ring, perpendicular to the axial direction, formed of interconnected links.
PNG
media_image1.png
261
330
media_image1.png
Greyscale
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the outer periphery of the annular band disclosed by Chaisson to include a plurality of focal elevating elements disposed on said outer annular periphery, said focal elevating elements each having an axial dimension that is substantially parallel with the blood vessel wall axial direction that is equal to or less than a width of an adjoining strut of said annular band on which said focal elevating elements are disposed, said focal elevating elements being configured to reduce regional areas of contact of the device with the blood vessel wall, said annular band being dimensioned and designed to apply point pressure and elevate adjoining struts forming the thin annular band of the device off from contact with the blood vessel wall, as taught by Rhodes. This modification would allow the annular band to tightly engage, e.g., burrow slightly into, the interior of the vessel, duct, or lumen to fixedly secure the device in place (Rhodes, Column 7, lines 29-31).
Response to Arguments
Applicant's arguments filed 11/24/25 have been fully considered but they are not persuasive.
The Applicant has argued that there is no suggestion or motivation to combine the respective teachings of the Chaisson and Rhodes references. The Applicant argues that the modification to include barbs as taught by Rhodes would not have been obvious to one having ordinary skill in the art because the struts 30, 31 of Chaisson function to hold the ring 27 upright, preventing its rotation or tipping with respect to the central longitudinal axis of the lumen 12. The Applicant also argues that that the Office Action does not establish how the barbs of Rhodes could be applied to the ring of Chaisson while still allowing Chaisson to successfully go from a coiled to an uncoiled and locked position without interfering with its uncoiling and locking functions. The Examiner respectfully disagrees.
As pointed out by the Applicant, the struts 30, 31 of Chaisson function to hold the ring 27 upright, preventing its rotation or tipping with respect to the central longitudinal axis of lumen 12 (Column 5, lines 59-62). This is a different function than what the barbs disclosed by Rhodes provide. Rhodes teaches that the barbs tightly engage, e.g., burrow slightly into, the interior of the vessel, duct, or lumen to fixedly secure the device in place (Column 7, lines 29-32). Rhodes further teaches that the force applied to the barbs by the fluid flowing through the vessel, duct, or lumen, in which the device is secured produces a force component extending in the direction of the fluid flow and a force component extending perpendicularly to that direction. This action causes the projections to tightly engage the interior of the wall of the vessel, duct, or lumen to fixedly secure the device in place against migration (Column 9, lines 1-17). One having ordinary skill in the art would recognize that the addition of the barbs taught by Rhodes would fixedly secure the device in the upright position (provided by the struts of Chaisson), by burrowing slightly into the wall of the vessel, and would also prevent any possible migration of the device.
The claim recites “a thin, annular band or durable, flexible material having a plurality of barbs or anchoring elements on an outer annular periphery of the band… wherein the plurality of barbs or anchoring elements have a dimension in an axial direction that is less than the width of the annular band in the axial in the axial direction.” The claim does not specify an exact number of barbs or anchoring elements. Therefore, the addition of two barbs to the outer annular periphery would read on claim. Rhodes teaches one having ordinary skill in the art will recognize that the number of projections used in any device will be a factor in the amount of securement against migration (Column 8, lines 38-42). One having ordinary skill in the art would recognize that barbs can be positioned on the outer periphery of the band in the tightly coiled condition shown in Figure 9A of Chaisson and would not interfere with the uncoiling and locking functions of the band.
For these reasons, the Examiner maintains that the claims as currently written do not distinguish over the combined teaching of the Chaisson reference in view of Rhodes reference.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771