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
Applicant’s election of claims 1-5 and 9-18 in the reply filed on August 21, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 6-8 and 19-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August,21, 2026.
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.
Claims 16-18 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.
Regarding claim 16, the phrase "a cover" renders the claim indefinite because claim 16 recites “a cover” twice in the claiming which is unclear whether each recitation refers to the same “cover” or not.
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 1(rejection I) is rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Jiang” (US20190032359A1).
Regarding claim 1(rejection I).
Jiang teaches A medical device (Abstract; the term medical is merely functional language and is not given patentable weight. Alternatively, the umbrella of Jiang may be capable of a medical-related use, such as keeping a patient's medical cast dry), comprising:
a frame (umbrella ribs 9) configured to transition from a contracted configuration to an expanded configuration (Paragraph 0037: “The umbrella cloth 1 is supported by the umbrella ribs 9.”, Paragraph 0040: “opening and closing of the umbrella ribs 9 are driven by a motor, and the storage battery 8 supplies power to the motor under control of the control device 6.”, and Paragraph 0063: “Meanwhile, the stretch and retraction of the umbrella may be realized through corotation or contrarotation of the motor 1003, wherein the umbrella stretches upon the corotation of the motor, and the umbrella retracts upon the contrarotation of the motor.”); and
a cover (umbrella cloth 1) disposed on the frame (umbrella ribs 9) (Paragraph 0037: “The umbrella cloth 1 is supported by the umbrella ribs 9.”, Paragraph 0059: “two support rods 110 of one piece of umbrella cloth 1 are respectively located inside the auxiliary slide rails 915 of the slide rails 910 of two neighboring umbrella ribs 9”, and Paragraph 0068: “The solar cells 101 are packaged on the umbrella cloth 1, the umbrella cloth 1 is supported by the umbrella ribs 9”),
wherein the cover (umbrella cloth 1) includes a plurality of projections (solar cells 101) extending radially outward from an outer surface of the cover (outer surface of umbrella cloth 1) (Paragraph 0037: “The umbrella cloth 1 is supported by the umbrella ribs 9.”, Paragraph 0047: “In practical manufacture, the solar cells 101 may also be directly packaged with the umbrella cloth 1 by adopting manners in the prior art such as stitching and pasting.”, and Fig.1 illustrates the solar cells 101 (projections) attached on the umbrella cloth 1 outward direction form the outer surface of the umbrella cloth 1).
Claim 16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Markowitz” (US20190261962A1).
Regarding claim 16.
Markowitz A medical device (A collection device 10) (Abstract), comprising:
a handle (stopcock and syringe) (Paragraph 0025: “A proximal end of the support 20 may be connected to a stopcock and syringe to control the injection of fluid to move the distal end portion 16 between the collapsed and expanded positions”) (the examiner notes that the stopcock and syringe correspond to the claimed handle because they form the proximal operator-manipulated portion of the device for controlling distal portion 16);
a shaft (support member 20) (Paragraph 0061: “The proximal axial end portion 14 is connected to a support member 20, such as a catheter. The support member 20 may be a tubular member in fluid communication with the interior of the collection portion 12’);
a distal end (distal axial end portion 16) coupled to a distal end of the shaft (support member 20) (Paragraph 0024: “The collection device 10 includes a generally hollow longitudinally extending collection portion 12. The collection portion 12 has a first or proximal axial end portion 14 and a second or distal axial end portion 16”, “The first axial end portion 14 and the second axial end portion 16 may be integrally formed as one-piece or may be formed as separate pieces that are connected together in any desire manner”, Paragraph 0025: “The proximal axial end portion 14 is connected to a support member 20, such as a catheter.”, paragraph 0026: “The second or distal end portion 16 of the collection portion 12 has an expanded or inflated position (FIG. 1) and a collapsed or deflated position (FIGS. 2-3).”, and Paragraph 060: “A fifth exemplary embodiment of a collection device constructed in accordance with the present invention is illustrated in FIG. 10. The collection device of FIG. 10 is generally similar to the collection devices of FIGS. 1-9. Accordingly, similar numerals will be used to describe similar components.”) (the examiner notes that support member 20 (shaft), proximal end portion 14, and distal end portion 16 may comprise separate but coupled components., Accordingly, the end of support member 20 that is coupled to proximal end portion 14 is considered as the " distal end of shaft") and
configured to expand and contract (paragraph 0024: “. The distal axial end portion 16 may expand and contract.”, “The proximal axial end portion 14 and the distal axial end portion 16 may be made of a flexible polymer, such as silicone or polyurethane.”, Paragraph 0026: “The second or distal end portion 16 of the collection portion 12 has an expanded or inflated position (FIG. 1) and a collapsed or deflated position (FIGS. 2-3).”, and Paragraph 0030: “The distal end portion 16 has an outer surface 32 for collecting tissue when the distal portion is in the expanded position”),
the distal end (distal axial end portion 16) including a cover having: a substrate (base material of distal end portion 16); and a cover including an outer surface (outer surface 32 of distal end portion 16) with a plurality of projections (projections or bristles 40) extending radially outward therefrom (Paragraph 0024: “The proximal axial end portion 14 and the distal axial end portion 16 may be made of a flexible polymer, such as silicone or polyurethane.”, and Paragraph 0030: “The distal end portion 16 has an outer surface 32 for collecting tissue when the distal portion is in the expanded position.”, “The outer surface 32 of the distal end portion 16 may have a plurality of projections or bristles 40 for collecting tissue.” ) (the examiner notes that the base material (e.g. flexible polymer material/body) forming distal end portion 16 may correspond to the claimed substrate).
Regarding 18, Markowitz teaches the medical device of claim 16 (see rejection of claim 16 above).
Markowitz teaches wherein the substrate (base material of distal end portion 16) is flexible (Paragraph 0024: “The proximal axial end portion 14 and the distal axial end portion 16 may be made of a flexible polymer, such as silicone or polyurethane”, “The distal axial end portion 16 may expand and contract.”, Paragraph 0026: “The second or distal end portion 16 of the collection portion 12 has an expanded or inflated position (FIG. 1) and a collapsed or deflated position (FIGS. 2-3).”).
.
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 1 (rejection II) is rejected under 35 U.S.C. 103 as being unpatentable over “Markowitz” (US20190261962A1) in view of “Bourne” (WO 2017054015 A2).
Regarding claim 1(rejection II).
Markowitz teaches A medical device (collection device 410), comprising:
Markowitz teaches wherein the cover (Projection-bearing distal end portion 416) includes a plurality of projections (projections or bristles 440 or 460) extending radially outward from an outer surface of the cover (outer surface 432) (Paragraph 0061: “A collection device 410 (FIG. 10) includes a generally hollow longitudinally extending collection portion 412. The collection portion 412 has a first or proximal axial end portion 414 and a second or distal axial end portion 416. The distal axial end portion 416 may expand and contract”, Paragraph 0066: “The distal end portion 416 has an outer surface 432 for collecting biological samples. The outer surface 432 of the distal end portion 416 may have a plurality of projections or bristles 440 for collecting biological samples.”, Paragraph 0067: “The distal end portion 416 may include a plurality of projections or bristles 460 extending from a distal portion of the distal end portion 416. The projections 460 have the same general V-shape as the projections 440.”).
However, Markowitz does not teach a frame configured to transition from a contracted configuration to an expanded configuration; and
a cover disposed on the frame,
Bourne teaches a frame (expandable structure 164) configured to transition from a contracted configuration to an expanded configuration (Paragraph 0016: “Further, components of the system may be modified for delivery, removal, injection, tissue collection, inspection, or other treatments.”, Paragraph 0014: “The structure of the collapsible airway bypass device comprises an air intake component surrounded by a scaffold structure”, “the scaffolding may also be known as the expandable structure and may comprise a scaffolding, a cage, a basket, a mesh, a weave, or a stent that can be delivered in a smaller, undeployed state and expanded to a larger deployed state having an increased diameter and volume.”, and Paragraph 0045: “the expandable structure 164 comprises filaments, wire or struts deployed into an expanded state.”); and
a cover (material or membrane 172) disposed on the frame (expandable structure 164) (Paragraph 0060: “the expandable structure 164 may be covered by a material or membrane 172”, “the membrane may partially, selectively or fully cover the device 150”),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Markowitz with the expandable structure as taught by Bourne because incorporating the expandable structure would have facilitated controlled deployment and expansion of the collection portion (Bourne, Paragraphs 0054).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Markowitz in view of Bourne and “Greenhalgh” (WO2020210840A1).
Regarding claim 2, Markowitz in view of Bourne teaches the medical device of claim 1 (see rejection of claim 1 (rejection II) above).
Markowitz does not teach further comprising a control element coupled to the frame, wherein movement of the control element is configured to transition the frame from the contracted configuration to the expanded configuration, and wherein the control element is a hypotube configured to receive a guidewire.
Bourne teaches further comprising a control element (pull wire) coupled to the frame (expandable structure 164) (Paragraph 0054: “an expandable structure 164 may be configured to deploy by applying tension to a pull wire connected to a distal end of the expandable structure 164 to reduce the axial length of the expandable structure.”),
wherein movement of the control element is configured to transition the frame from the contracted configuration to the expanded configuration (Paragraph 0054: “an expandable structure 164 may be configured to deploy by applying tension to a pull wire connected to a distal end of the expandable structure 164 to reduce the axial length of the expandable structure.”, “The pull wire passes through a pull wire hole in an air intake component and pass through a lumen in a conduit to a proximal region of the device external to the patient where a proximal portion of the pull wire is terminated in an end piece.”), and
Greenhalgh wherein the control element (inner member) is a hypotube (guidewire lumen through the inner member) configured to receive a guidewire (guidewire) (Paragraph 0071: “The biopsy collector may be expandable”,” The device may be deployed by relative motion between the inner member and the outer member that allows the biopsy collector to expand”,” the biopsy collector may be collapsed back down”, Paragraph 0148: “The inner member may be a rod, wire, cannula, hypotube, etc”, and Paragraph 0018: “the apparatus is configured for use with a guidewire. Thus, the inner member and the biopsy collector may be formed to include a continuous longitudinal passage for a guidewire or guide catheter. Thus, any of these devices may include a guidewire lumen thought the inner member and the biopsy collector.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Markowitz with the pull-wire-actuated expandable structure as taught by Bourne because such modification would have allowed the expandable structure to be deployed by applying tension to the pull wire to reduce the axial length of the expandable structure (Bourne, Paragraph 0054).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Markowitz in view of Bourne with the hypotube and guidewire arrangement as taught by Greenhalgh because such modification would have allowed the biopsy device to advance over a guidewire previously positioned within a body lumen, thereby providing a predetermined desired path for advancing the device toward the tissue collection site with a guidewire for deployment to a target site (Greenhalgh, Paragraphs 0018,0148).
Claims 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz in view of Bourne and “Daniel” (US20060100662A1).
Regarding claim 3, Markowitz in view of Bourne teaches the medical device of claim 1 (see rejection of claim 1 (rejection II) above).
Markowitz does not teach wherein the frame includes a first, proximal plurality of struts and a second, distal plurality of struts, and wherein an inner surface of the cover is coupled to the second, distal plurality of struts.
Daniel teaches wherein the frame includes a first, proximal plurality of struts (struts 162) and a second, distal plurality of struts (struts 164) (Paragraph 0063: “FIG. 14C illustrates a distal protection device 160 which is similar to that shown in FIG. 14A. However, rather than simply providing a slotted tube, distal protection device 160 includes a plurality of struts 162 on a proximal region thereof and a plurality of struts 164 on the distal region thereof”).
wherein an inner surface of the cover (filter or mesh portion 170) is coupled to the second, distal plurality of struts (struts 164) (Paragraph 0063: “Also, struts 164 have secured to the interior surface thereof a filter or mesh portion 170”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Markowitz by incorporating the proximal and distal pluralities of struts as taught by Daniel because such modification would have provided a plurality of struts 162 at a proximal region and a plurality of struts 164 at a distal region, with filter or mesh portion 170 secured to the interior surface of the distal struts 164 (Daniel, Paragraph 0063; Fig.14C).
Regarding claim 9, Markowitz in view of Bourne teaches the medical device of claim 1 (see rejection of claim 1 (rejection II) above).
Markowitz does not teach wherein the cover has a substantially conical shape in the expanded configuration of the frame.
Daniel teaches wherein the cover (mesh 47) has a substantially conical shape in the expanded configuration of the frame (struts 46) (Paragraph 0042:” Filter assembly 44 includes a plurality of inflatable struts 46 and mesh 47.”, “Struts 46 are preferably configured such that, upon being inflated, the proximal ends 50 deploy radially outwardly away from the outer surface of hollow guidewire 42”, Paragraph 0043: “Mesh 47, as with mesh 22 shown in FIG. 1, is deployed either on the outer or inner surface of inflatable struts 46, such that, when the inflatable struts 46 are deployed radially outwardly, mesh 47 forms a generally conical basket opening toward the proximal end of hollow guidewire 42.As with the embodiment shown in FIG. 1, mesh 47 can be applied to either the outer or the inner surface of struts 46. It can be applied to struts 46 as one unitary conical piece which is adhered about distal ends 48.”, and Paragraph 0045: “FIG. 7 is a cross-sectional view of a portion of distal protection device 40 shown in FIGS. 5 and 6. FIG. 7 shows filter assembly 44 in the collapsed position in which it approximates the outer diameter of guidewire 42”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Markowitz by incorporating the conical configuration at taught by Daniel because such modification would have provided a substantially lumen-filing structure for receiving and retaining material (Daniel, Paragraphs 0043-0044) and furthermore, the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz in view of Bourne, Daniel, and “Kreidler” (US20140350592A1).
Regarding claim 4, Markowitz in view of Bourne and Daniel teaches the medical device of claim 3 (see rejection of claim 3 above).
Markowitz does not teach wherein distal ends of the second, distal plurality of struts are coupled to a clevis, and wherein the clevis includes a lumen configured to receive a guidewire.
Kreidler teaches wherein distal ends of the second, distal plurality of struts (struts 17) are coupled to a clevis (distal hub 314) (Paragraph 0053: “the frame 506 comprises a plurality of radially outwardly extending supports, struts or spokes 17 each having a collapsed length within the range of from about 0.5 cm to about 5 cm from a proximal hub 324 to a distal hub 314.”, and Paragraph 0054: “each of the struts 17 extends between a proximal hub 324 and a distal hub 314. The proximal and distal hubs may be cylindrical tubular sections,”), and
wherein the clevis includes a lumen (central hole 601) configured to receive a guidewire (guidewire) (Paragraph 0115: “the implant 304 has a proximal hub 324 with internal threads 600 and a distal hub 314 with an optional central hole 601 for slideably receiving a guidewire (not shown).”, and Paragraph 0117: “Hollow delivery wires 602 can be used over a guidewire (not shown), wherein the guidewire preferably passes through a hole in the distal hub 314”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Markowitz by incorporating the distal hub 314 and central hole 601 as taught by Kreidler because such modification would have provided the medical device to be advanced over a guidewire to a desired location within a patient’s anatomy, thereby facilitating delivery and positioning of the device (Kreidler, Paragraph 0054,0115,0117).
Regarding claim 5, Markowitz in view of Bourne, Daniel, and Kreidler teaches the medical device of claim 4 (see rejection of claim 4 above).
Markowitz does not teach wherein the cover includes an opening, and wherein the opening is aligned with the lumen of the clevis.
Kreidler teaches wherein the cover (barrier 15) includes an opening, and wherein the opening is aligned with the lumen (central hole 601) of the clevis (distal hub 314) (the examiner notes that, as illustrated in Figs 1 and 6, distal hub 314 extends distally beyond barrier 15, which is disposed over frame 506. Accordingly, barrier 15 would necessarily include an opening aligned with central hole 601 of distal hub 314 to permit passage of a guidewire therethrough. This interpretation is further supported by paragraph 0117, which discloses that the guidewire passes through a hole in distal hub 314; Paragraph 0055: “As shown in FIG. 1, a barrier 15 is provided over at least a proximal face of the device 304. The barrier 15 may comprise any of a variety of materials which facilitate cellular in-growth, such as ePTFE. The suitability of alternate materials for barrier 15 can be determined through routine experimentation by those of skill in the art. The barrier 15 may be provided on either one or both sides of the struts 17. In one embodiment, the barrier 15 comprises two layers, with one layer on each side of the frame 506.”, Paragraph 0115: “the implant 304 has a proximal hub 324 with internal threads 600 and a distal hub 314 with an optional central hole 601 for slideably receiving a guidewire (not shown).”, and Paragraph 0117: “Hollow delivery wires 602 can be used over a guidewire (not shown), wherein the guidewire preferably passes through a hole in the distal hub 314”) (the examiner notes that Figs. 1 and 6 illustrate the barrier 15 (cover) appears to include an opening aligned with the lumen (central hole 601) of the clevis (distal hub 314).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Markowitz by incorporating the distal hub 314 and central hole 601 as taught by Kreidler at the distal opening 122 of the filter material 118 because such modification would have facilitated advancement of the medical device along a guidewire to a desired target site while maintaining an unobstructed guidewire passage through the cover and distal hub (Kreidler, Paragraphs 0055, 0115, 0117).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Markowitz in view of Bourne, Daniel and “Dvorsky” (US 20200390547 A1).
Regarding claim 10, Markowitz in view of Bourne and Daniel teaches the medical device of claim 9 (see rejection of claim 9 above).
Markowitz does not teach wherein the cover has a substantially cylindrical shape in the contracted configuration of the frame.
Dvorsky teaches wherein the cover (outer skirts) has a substantially cylindrical shape in the contracted configuration of the frame (frame 302) (Paragraph 0194: “The frame 302 is another example of a Lobachevsky frame. Similar to prosthetic valve 10, the prosthetic valve 300 can include a valvular structure (e.g., valvular structure 18), inner and/or outer skirts”, Paragraph 0210: “crimping can radially compress the prosthetic valve until it has a null draft angle, meaning the prosthetic valve in the fully compressed configuration is cylindrical.”, and Paragraph 0211: “The frame 302 can be retained in a barrel or cylindrical configuration by a delivery apparatus”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Markowitz with the cylindrical compressed configuration as taught by Dvorsky because such modification would have allowed the device to be retained in a cylindrical configuration by a delivery apparatus for delivery (Dvorsky, Paragraphs 0210,0211) and furthermore, the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
.
Claim 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz in view of Bourne, Daniel and “Neoh” (US20140046357A1).
Regarding claim 11, Markowitz in view of Bourne and Daniel teaches the medical device of claim 9 (see rejection of claim 9 above).
Markowitz does not teach wherein the plurality of projections are arranged in a plurality of columns.
Neoh teaches wherein the plurality of projections (brush hairs) are arranged in a plurality of columns (the examiner notes that the longitudinally extending rows of projection 140 illustrated in Figs. 1-2 are interpreted as the claimed plurality of columns because the projections are arranged in substantially straight rows extending longitudinally along dilator tip 130, and the claim does not specify a particular orientation for the columns; Paragraph 0028: “the projections 140 may be arranged on the outer surface 138 of the dilator tip 130 in any desired pattern. In one example, the projections 140 may be arranged in a series of substantially straight rows as shown in FIGS. 1-2. The rows of projections may be spaced from one another around the circumference of the dilator tip 130, and each row of projections may extend generally longitudinally along the dilator tip 130 in a substantially straight line.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Markowitz in view of Bourne and Daniel with the longitudinal extending rows of projections as taught by Neoh because incorporating such an arrangement would have allowed the projections to engage tissue along the length and around the circumference of the device (Neoh, Paragraph 0028).
Regarding claim 12, Markowitz in view of Bourne, Daniel, and Neoh teaches the medical device of claim 11 (see rejection of claim 11 above).
Markowitz does not teach wherein, in the expanded configuration, a circumferential distance between adjacent columns of the plurality of columns is greater at a proximal end of the cover than at a distal end of the cover.
Neoh teaches wherein, in the expanded configuration, a circumferential distance between adjacent columns (projections) of the plurality of columns is greater at a proximal end of the cover (outer surface) than at a distal end of the cover (outer surface) (Paragraph 0023: “the proximal end 132 of the dilator tip 130 may have a larger diameter than the distal end 134 of the dilator tip.”, “The diameter of the outer surface 138 of the dilator tip 130 may change in a longitudinal direction between the proximal end 132 and the distal end 134 of the dilator tip 130.”, Paragraph 0028: “the projections 140 may be arranged on the outer surface 138 of the dilator tip 130 in any desired pattern. In one example, the projections 140 may be arranged in a series of substantially straight rows as shown in FIGS. 1-2. The rows of projections may be spaced from one another around the circumference of the dilator tip 130, and each row of projections may extend generally longitudinally along the dilator tip 130 in a substantially straight line.”, and Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Markowitz with the projection arrangement as taught by Neoh because incorporating such an arrangement would have reduced friction between the projections and surrounding tissue, thereby facilitating advancement of the device through a body lumen (Neoh, Paragraphs 0028, 0030-0031).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Markowitz in view of Bourne, Daniel, Neoh, and” Weldon” (US20150005665A1).
Regarding claim 13, Markowitz in view of Bourne, Daniel, and Neoh teaches the medical device of claim 12 (see rejection of claim 12 above).
Markowitz does not teach wherein, at the proximal end of the cover, the circumferential distance between adjacent columns of the plurality of columns is greater in the expanded configuration than in the contracted configuration.
Weldon teaches wherein, at the proximal end of the cover, the circumferential distance between adjacent columns of the plurality of columns is greater in the expanded configuration than in the contracted configuration (Paragraph 0044: “The dilator 200 may include an elongated shaft 206, and an expandable member 204 mounted on a distal portion of the shaft 206”, Paragraph 0045: “FIG. 2A shows the expandable member 204 in an expanded/inflated state, while FIG. 2B shows the expandable member 204 in an at least partially unexpanded/deflated state.”, Paragraph 0046: “The micropattern 210 may include protrusions 216 on the outer surface of the expandable member 204”, Paragraph 0047: “The expansion/inflation may also increase the size of the gaps 214. Cells, or portions thereof, may be received in the enlarged gaps 214. Once the dilation steps has been completed, the expandable member 204 may be deflated or otherwise allowed to return to its unexpanded state. As such, the size of the gaps 214 may decrease. As the gaps 214 become smaller, and the protrusions 216 move closer together,”, and Paragraph 0033: “The gaps 114 and/or the protrusions 116 may be configured to be arranged in an array of rows and columns around the bristle 107, thereby forming the micropattern 110”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Markowitz with the expandable projection arrangement as taught by Weldon because such modification would have allowed the gaps between the projections to increase upon expansion and decrease upon contraction, thereby facilitating collection and retention of biological material (Weldon, Paragraph 0047).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Markowitz in view of Bourne, and Weldon.
Regarding claim 14, Markowitz in view of Bourne teaches the medical device of claim 1 (see rejection of claim 1 (rejection II) above).
Markowitz does not teach wherein the cover is stretchable.
Weldon teaches wherein the cover is stretchable (Paragraph 0044: “The expandable member 204 may be made of an elastic material that may stretch/deform when expanded by an expanding force, and may return to its original form when the expanding force is removed.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cover of Markowitz with the elastic material as taught by Weldon because incorporating such material would have allowed the cover to stretch/deform during expansion and return toward its original form when the expanding force is removed (Weldon, Paragraph 0044).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Markowitz in view of Bourne, and Kreidler.
Regarding claim 15, Markowitz in view of Bourne teaches the medical device of claim 1 (see rejection of claim 1 (rejection II) above).
Markowitz does not teach wherein the medical device is configured to receive a guidewire along a central longitudinal axis of the frame.
Kreidler teaches wherein the medical device is configured to receive a guidewire (guidewire) along a central longitudinal axis of the frame (expandable frame 506) (Paragraph 0115: “In the preferred embodiment of FIG. 14, the implant 304 has a proximal hub 324 with internal threads 600 and a distal hub 314 with an optional central hole 601 for slideably receiving a guidewire (not shown).”, Paragraph 0117: “the delivery wire 602 can be hollow. Hollow delivery wires 602 can be used over a guidewire (not shown), wherein the guidewire preferably passes through a hole in the distal hub 314”, Paragraph 0054: “The implantable device 304 comprises an expandable frame 506. In the illustrated embodiment, the frame 506 comprises a plurality of radially outwardly extending supports, struts or spokes 17 each having a collapsed length within the range of from about 0.5 cm to about 5 cm from a proximal hub 324 to a distal hub 314 “, “the struts 17 are biased radially outwardly such that the device 304 expands to its enlarged”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Markowitz with the guidewire arrangement as taught by Kreidler because incorporating such an arrangement would have allowed the device to be slidably received over a guidewire for delivery and positioning of the device (Kreidler, Paragraphs 0115-0117).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Markowitz in view of Kreidler.
Regarding 17, Markowitz teaches the medical device of claim 16 (see rejection of claim 16 above).
Kreidler teaches wherein the distal end (distal portion of implantable device 304 including barrier 15 and frame 506) further includes a frame (frame 506) (Paragraph 0053: “The implantable device 304 comprises an expandable frame 506. the frame 506 comprises a plurality of radially outwardly extending supports, struts or spokes 17 each having a collapsed length within the range of from about 0.5 cm to about 5 cm from a proximal hub 324 to a distal hub 314.”), and
wherein the cover (barrier 15) is attached to the frame (frame 506) (Paragraph 0055: “a barrier 15 is provided over at least a proximal face of the device 304”, “The barrier 15 may be provided on either one or both sides of the struts 17”, “the barrier 15 comprises two layers, with one layer on each side of the frame 506”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end of Markowitz with the expandable frame and attached barrier as taught by Kreidler because Incorporating such a structure would have provided an expandable supporting frame to support and retain the cover during expansion (Kreidler, Paragraphs, 0053-0055).
Conclusion
17. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Clarke (US7318444B2) is pertinent because Clarke discloses a device having an expandable structure configured to transition between contracted and expanded configurations.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MORGAN S SHIM whose telephone number is (571)272-9032. The examiner can normally be reached Mon-Fri 7:30AM-4:30PM.
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.
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/MORGAN SANGJO SHIM/ Examiner, Art Unit 3791
/PATRICK FERNANDES/ Primary Examiner, Art Unit 3791
