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 .
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.
Response to Arguments
Applicant’s arguments, filed 1/13/26, with respect to claim objection have been fully considered and are persuasive. The objections of claims 1 and 17 have been withdrawn.
Applicant’s arguments, filed 1/13/26, with respect to 35 USC 112(b) rejections have been fully considered and are persuasive. The rejection of claim 5 has been withdrawn.
Applicant's arguments filed 1/13/26, with respect to 35 USC 103 rejections of claims 1 and 17 have been fully considered and are persuasive. Examiner agrees of Bluecher 2020 in view of Bluecher 20180147321 fails to disclose the second hierarchical microstructure pattern comprises a plurality of microridges arranged in groupings forming islands, wherein the microridges have an airfoil profile configured to direct particulate away from the inner surface as now recited in amended claims 1 and 17. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bluecher 2020, Bluecher 2018, and Glezer 2008.
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.
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.
Claim(s) 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bluecher (20200030124), herein referred to as “Bluecher 2020,” in view of Bluecher (20180147321), herein referred to as “Bluecher 2018,” and further in view of Glezer (20080121046).
Regarding claim 1, Bluecher 2020 discloses an endoprosthesis (200) for placement in a body lumen ([0006]) comprising: a tubular member ([0010], FIG 2) having an outer surface (See annotated figure 1 below) and an inner surface (See annotated figure 1 below), the outer surface (See annotated figure 1 below) comprising a first hierarchical microstructure pattern (216, [0061]) that is arranged to generate a Wenzel-Cassie state ([0060]), the inner surface comprising a second hierarchical microstructure pattern (220, [0061]) that is different than the first hierarchical microstructure pattern (see Fig. 3 and [0065] describing 220 being a different hierarchical pattern than 216). Bluecher 2020 discloses the inner surface being hydrophobic ([0019]), but fails to disclose the inner surface being superhydrophobic or oleophobic.
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Bluecher 2018 also discloses a microstructured implant (see [0028], [0030]). Bluecher 2018 teaches the microstructural elements being deposited in a superhydrophobic pattern on the surface of the implant ([0112]), thereby rendering the surface superhydrophobic or oleophobic. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner surface of Bluecher 2020 to be superhydrophobic or oleophobic, as taught by Bluecher 2018 in order to discourage attachment of bacterial cells ([0036]), which directly relates to the goal of Bluecher 2020 to include an anti-fouling surface that resists the accumulation of a cell ([0049]).
Bluecher 2020 as modified fails to disclose that the second hierarchical microstructure pattern comprises a plurality of microridges arranged in groupings forming islands, wherein the microridges have an airfoil profile configured to direct particulate away from the inner surface. Glezer also discloses a microstructured implant (FIG 2). Glezer teaches a hierarchical microstructure pattern that comprises a plurality of microridges arranged in groupings forming islands (see annotated figure 2 below), wherein the microridges have an airfoil profile ([0039]) configured to direct particulate away from the inner surface ([0029], Fig. 3, vortex generators reduce shear stress by directing flow away from the vessel surface). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the second hierarchical microstructure pattern of Bluecher 2020 as modified to comprise a plurality of microridges arranged in groupings forming islands, wherein the microridges have an airfoil profile configured to direct particulate away from the inner surface, as taught be Glezer, in order to minimize shear stress on the blood contacting inner surface, thereby reducing the risk of thrombus formation ([0004], [0009]).
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Regarding claim 2, Bluecher 2020 as modified by Bluecher 2018 and Glezer discloses the endoprosthesis of claim 1, wherein the tubular member ([0010], FIG 2) further comprises a polymer wall (206) such that the outer surface (See annotated figure 1 above) and inner surface (See annotated figure 1 above) are positioned on opposing sides of the polymer wall ([0065], “the polymeric coating (206) may include a hierarchical pattern (216) that is the same pattern at both the outer surface (See annotated figure 1 above) and inner surface (See annotated figure 1 above)”), and wherein at least one through-hole ([00121], fluidly connects the outer surface (See annotated figure 1 above) and the inner surface (See annotated figure 1 above)).
Regarding claim 3, Bluecher 2020 as modified by Bluecher 2018 and Glezer fail to disclose the endoprosthesis of claim 1, wherein the first hierarchical microstructure pattern (216) comprises a plurality of first microfeatures having a base and a top portion wherein each of the first microfeatures of the plurality of first microfeatures include the base having a recurved pillar.
However, in another embodiment (see FIG 8), Bluecher 2020 discloses a similar hierarchical endoprosthesis. Further, Bluecher 2020 teaches the first hierarchical microstructure pattern (216) comprises a plurality of first microfeatures (804) having a base (812) and a top portion (814) wherein each of the first microfeatures (804) of the plurality of first microfeatures include the base having a recurved pillar ([0094], textures of micropillars can include a flared bottom end).
Therefore, it would have been obvious to one of ordinary skill in the art at the effecting filing date of the claimed invention to modify the combination of Bluecher 2020, Bluecher 2018, and Glezer such that the first hierarchical microstructure pattern comprises a plurality of first microfeatures having a base and a top portion, wherein each of the first microfeatures includes the base having a recurved pillar, as taught and suggested by Bluecher 2020, in another embodiment to improve tissue attachment ([0094]).
Regarding claim 4, Bluecher 2020 as modified by Bluecher 2018 and Glezer fails to disclose the endoprosthesis of claim 3, wherein the first hierarchical microstructure pattern (216) comprises a plurality of second microfeatures disposed about the top portion of the plurality of first microfeatures.
However, in another embodiment (see FIG 8), Bluecher 2020 discloses a similar hierarchical endoprosthesis. Further, Bluecher 2020 teaches the first hierarchical microstructure pattern (216) comprises a plurality of second microfeatures (806) disposed about the top portion (814) of the plurality of first microfeatures (806).
Therefore, it would have been obvious to one of ordinary skill in the art at the effecting filing date of the claimed invention to modify the combination of Bluecher 2020 and Bluecher 2018 such that the first hierarchical microstructure pattern (216) comprises a plurality of second microfeatures disposed about the top portion of the plurality of first microfeatures, as taught and suggested by Bluecher 2020 in another embodiment, to improve tissue attachment ([0094]).
Regarding claim 5, Bluecher 2020 as modified by Bluecher 2018 and Glezer discloses the plurality of first microfeatures (804) may have a pitch between adjacent microfeatures from 25-100 microns ([0078], “the height may be 1 to 10 times the pitch”) and a height (810) from 10-100 microns ([0088], “the high end of the dimensions measure may be equal to the height,” “the dimension measure may be between 1 micron and 100 microns”).
Regarding claim 6, Bluecher 2020 as modified by Bluecher 2018 and Glezer discloses the endoprosthesis of claim 1, but fails to disclose that wherein the second hierarchical microstructure pattern comprises a plurality of microridges wherein each microridge of the plurality of microridges has a pitch between adjacent microridges from 100 nm to 10 microns.
However, in another embodiment (see FIG 8), Bluecher 2020 discloses a similar hierarchical endoprosthesis. Further, Bluecher teaches the second hierarchical microstructure pattern (806) comprises a plurality of microridges ([0078], “the second texture may be… ridges”) wherein each microridge of the plurality of microridges has a pitch between adjacent microridges from 100 nm to 10 microns ([0087], “the high end of the dimensions measure may be equal to the height,” “the dimension measure… is between 25 and 150 microns for a second texture,” [78], “the height may be 1 to 10 times the pitch”).
Therefore, it would have been obvious to one of ordinary skill in the art at the effecting filing date of the claimed invention to modify the combination of Bluecher 2020, Bluecher 2018, and Glezer to incorporate the second hierarchical microstructure pattern comprising a plurality of microridges, wherein each microridge of the plurality of microridges has a pitch between adjacent microridges from 100 nm to 10 microns, as taught and suggested by Bluecher 2020 in another embodiment, to improve tissue attachment ([0094]).
Regarding claim 7, Bluecher 2020 as modified by Bluecher 2018 and Glezer discloses the endoprosthesis of claim 6, wherein each microridge of the plurality of microridges ([0078], “the second texture may be… ridges”) comprise a length that is greater than a width ([0077], “Embodiments of the present disclosure contemplate polygonal cross-sections having all sides of equal length, combinations of sides of equal length and unequal length”).
Regarding claim 8, Bluecher 2020 as modified by Bluecher 2018 and Glezer discloses the endoprosthesis of claim 7, wherein the plurality of microridges ([0078], “the second texture may be… ridges”) comprises a subset of microridges wherein a height of each adjacent microridge increases progressively ([0078], “in a hierarchical arrangement there is a base structure that may be stepped as in an ascending and descending staircase”).
Regarding claim 9, Bluecher 2020 as modified by Bluecher 2018 and Glezer discloses the endoprosthesis of claim 8, wherein the plurality of microridges comprises a second subset of microridges ([0078], “the second texture may be… ridges”) wherein a height of each adjacent microridge decreases progressively ([0078], “in a hierarchical arrangement there is a base structure that may be stepped as in an ascending and descending staircase”).
Regarding claim 10, Bluecher 2020 as modified by Bluecher 2018 and Glezer discloses the endoprosthesis of claim 9, wherein the first subset of microridges ([0078], “the second texture may be… ridges”) is adjacent the second subset of microridges ([00102], “each micropillar or texture may include a longitudinal axis and the micropillars are axially aligned in at least one of the axial directions (e.g., arranged in a row parallel to a longitudinal axis of a stent)”).
Regarding claim 11, Bluecher 2020 as modified by Bluecher 2018 and Glezer discloses the endoprosthesis of claim 7 wherein the length of each microridge of the plurality of microridges ([0078], “the second texture may be… ridges”) is arranged coaxially with a central axis of the tubular member ([0091], “adorned with axially concentric parallel ridges”).
Regarding claim 12, Bluecher 2020 as modified by Bluecher 2018 and Glezer discloses the endoprosthesis of claim 7 wherein the length of each microridge of the plurality of microridges ([0078], “the second texture may be… ridges”) is arranged circumferentially ([00102], “the micropillars are axially aligned in… the circumferential direction of the endoprosthesis (e.g., arranged in a row extending circumferentially around a longitudinal axis of a stent)”) along the inner surface of the tubular member ([0065], “the polymeric coating may also at least partially cover the inner surface 212 at location 218”).
Regarding claim 13, Bluecher 2020 as modified by Bluecher 2018 and Glezer discloses the endoprosthesis of claim 1, wherein the first hierarchical microstructure (216) covers a portion of the outer surface ([0064], “the copolymeric coating 206 may include a hierarchical pattern 216 on the outer surface of the copolymeric coating”).
Regarding claim 14, Bluecher 2020 as modified by Bluecher 2018 and Glezer discloses the endoprosthesis of claim 1, but fails to disclose wherein the outer surface (See annotated figure 1 above) comprises a third microstructure pattern different from the first microstructure pattern, configured to transport fluid from a first location to a second location.
However, in another embodiment (see FIG 4), Bluecher 2020 discloses a similar hierarchical endoprosthesis. Here, Bluecher teaches a third microstructure pattern (422) different from the first microstructure pattern (412), configured to transport fluid from a first location to a second location ([0094], “capillary action aspect” allows for fluid transport).
Therefore, it would have been obvious to one of ordinary skill in the art at the effecting filing date of the claimed invention to modify the combination of Bluecher 2020, Bluecher 2018, and Glezer to the outer surface (See annotated figure 1 above) comprises a third microstructure pattern different from the first microstructure pattern, configured to transport fluid from a first location to a second location, as taught and suggested by Bluecher 2020 in another embodiment, to improve tissue attachment ([0094]).
Regarding claim 15, Bluecher 2020 as modified by Bluecher 2018 and Glezer discloses the endoprosthesis of claim 14, wherein the third microstructure pattern (422) comprises a plurality of microfeatures having a pitch between adjacent microfeatures from 5-50 microns ([0087], “ratio of the pitch to the diameter is between about 1:2.1 and 1:10”), a width from 1-20 microns ([0087], “the dimension measure… is between 1 micron and 100 microns”), and a height from 5-50 microns ([0087], “the dimension measure… is between 1 micron and 100 microns”) ([0014] defines “dimension” as length, width, or height).
Regarding claim 16, Bluecher 2020 as modified by Bluecher 2018 and Glezer discloses the endoprosthesis of claim 1, wherein the tubular member comprises a first end (202) and a second end (204), the first end (202) and second end (204) being flared in relation to a central portion of the tubular member (Fig. 2).
8. Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Bluecher (20200030124), herein referred to as “Bluecher 2020,” in view of Bluecher (20180147321), herein referred to as “Bluecher 2018,” further in view of Bluecher (20210338405), herein referred to as “Bluecher 2021,” and further in view of Glezer (20080121046).
Regarding Claim 17, Bluecher 2020 discloses an endoprosthesis (200) for placement in the gastrointestinal tract ([0006]) comprising: a tubular member ([0010], FIG 2) having an outer surface (See annotated figure 1 above) and an inner surface (See annotated figure 1 above), the outer surface additionally comprising a plurality of pores ([00121], fluidly connects the outer surface (See annotated figure 1 above) and the inner surface (See annotated figure 1 above)), and comprising a second hierarchical microstructure pattern (220, [0061]) that is different than the first hierarchical microstructure pattern (see Fig. 3 and [0065] describing 220 being a different hierarchical pattern than 216). Bluecher 2020 discloses the inner surface being hydrophobic ([0019]), but fails to disclose the inner surface being superhydrophobic or oleophobic.
Bluecher 2018 also discloses a microstructured implant (see [0028], [0030]). Bluecher 2018 teaches the microstructural elements being deposited in a superhydrophobic pattern on the surface of the implant ([0112]), thereby rendering the surface superhydrophobic or oleophobic. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner surface of Bluecher 2020 to be superhydrophobic or oleophobic, as taught by Bluecher 2018 in order to discourage attachment of bacterial cells ([0036]), which directly relates to the goal of Bluecher 2020 to include an anti-fouling surface that resists the accumulation of a cell ([0049]).
Bluecher 2020 as modified fails to disclose the outer surface comprising a first hierarchical microstructure pattern that is multi-fractal, Bluecher 2021 discloses another microstructured implant and teaches that the outer surface comprises a first hierarchical microstructure pattern that is multi-fractal ([0109], “the microstructures may be arranged hierarchically, with a fractal dimension greater than 2”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Bluecher 2020 to have an outer surface comprising a first hierarchical microstructure pattern that is multi-fractal, as Bluecher 2021 teaches that a high fractal dimension leads to greater positional strength ([0109]), which is associated with a Wenzel-Cassie interface ([0055]).
Bluecher 2020 as modified fails to disclose that the second hierarchical microstructure pattern comprises a plurality of microridges arranged in groupings forming islands, wherein the microridges have an airfoil profile configured to direct particulate away from the dinner surface. Glezer also discloses a microstructured implant (FIG 2). Glezer teaches a hierarchical microstructure pattern that comprises a plurality of microridges arranged in groupings forming islands (see annotated figure 2 above), wherein the microridges have an airfoil profile ([0039]) configured to direct particulate away from the inner surface ([0029], Fig. 3, vortex generators reduce shear stress by directing flow away from the vessel surface). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the second hierarchical microstructure pattern of Bluecher 2020 as modified to comprise a plurality of microridges arranged in groupings forming islands, wherein the microridges have an airfoil profile configured to direct particulate away from the inner surface, as taught be Glezer, in order to minimize shear stress on the blood contacting inner surface, thereby reducing the risk of thrombus formation ([0004], [0009]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774