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 group I in the reply filed on 11/26/2025 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 Claims 18-34 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Information Disclosure Statement
The information disclosure statement filed 04/03/2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because a legible and translated copy of “research progress of minimally invasive surgery and equipment” has not been provided. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the collar of claim 11 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites “manifold” but should recite “the manifold”
Appropriate correction is required.
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 1-17 are 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.
Claim 1 recites “the first direction” without proper antecedent basis.
Claim 5 recites “the direction perpendicular to the first direction” in line 3 without proper antecedent basis. The Examiner would also recommend using another term for “the direction” such as “a second direction” for clarity.
Dependent claims are likewise rejected.
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.
Claim(s) 1 and 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Yuzhakov (US 7785301 B2) in view of Marin (US 5397355 A).
Regarding claim 1, Yuzhakov teaches a medical device comprising a substrate defining a major surface (abstract), the major surface defining a plane (see fig 2a), the major surface including a plurality of first struts along the major surface (see annotated figure 1) interconnected with a plurality of second struts extending along the major surface (see annotated figure 1), the second struts including intermediate sections having a plurality of projections extending therefrom (see annotated figure 1), wherein the intermediate sections of the second struts and the plurality of projections are operable to rotate relative to the first struts and bend out of the plane of the major surface substrate (see fig 3 and then bent out of plane figure 1) and wherein the plurality of projections including microneedles having lumens (see annotated figure 1) operable to be in fluid communication with a manifold (col 6, lines 5-8, aperture 20 ) and a fluid repository (reservoir, for example see col 2 line 66- col 3 line 12).
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Annotated figure 1
Yuzhakov fails to teach the details of the stretching. Marin teaches an improved stent (abstract) wherein the plurality of projections (barb 18) are operable to rotate relative to struts and bend out of the plane of the major surface substrate when the substrate is stretched in the first direction (col 2, line 40-col 3, line 15).
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 medical device taught by Yuzhakov by including a stretching activation method, as taught by Marin, in order to allow the medical device to have a controlled passive tissue protected state and tissue anchoring deployed state (col 1, lines 50-68, see fig 1 and 2).
Regarding claim 3, Yuzhakov further teaches wherein manifold has a therapeutic fluid contained therein (col 10 line 52- col 11 line 51, note fluid is flowing through aperture meaning the fluid is contained therein).
Regarding claim 4, Yuzhakov further teaches wherein the fluid repository is located adjacent a proximal end of the medical device (col 12, lines 39-40, structure is capable of being placed like this).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Yuzhakov (US 7785301 B2) in view of Marin (US 5397355 A) and in further view of Pacetti (US 20140330365 A1).
Regarding claim 2, Yuzhakov further teaches wherein the medical device has a lumen in fluid communication with the microneedles (see annotated figure 1) and the fluid repository (col 2 line 66- col 3 line 12).
Yuzhakov in view of Marin fails to teach the exact details of the first and second strut lumens. Pacetti teaches a hollow stent wherein the struts are of tubular construction and have lumens (see figures 1a, 1b, and 2).
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 first and second struts taught by Yuzhakov by including a hollow structure, as taught by Pacetti, in order to store pharmaceutical compositions until after implantation ([0099]).
Claim(s) 5-7, 10-11, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Yuzhakov (US 7785301 B2) in view of Marin (US 5397355 A) and in further view of Melsheimer (US 8764712 B2).
Regarding claim 5, Yuzhakov fails to teach the details of the fracture coating and stretching. Marin teaches an improved stent (abstract) and the rotation of the plurality of projections from the stretching of the substrate (col 2, line 40-col 3, line 15).
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 medical device taught by Yuzhakov by including a stretching activation method, as taught by Marin, in order to allow the medical device to have a controlled passive tissue protected state and tissue anchoring deployed state (col 1, lines 50-68, see fig 1 and 2).
Yuzhakov in view of Marin fails to teach the details of the fracture coating. Melsheimer teaches a microneedle device (abstract) further comprising a therapeutic coating covering the plurality of projections, and wherein stretching of the substrate along the direction perpendicular to the first direction is operable to fracture the therapeutic coating (col 5, lines 50-59).
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 medical device taught by Yuzhakov in view of Marin by including fracturable therapeutic coating, as taught by Melsheimer, in order to deliver a therapeutic agent during the transition state to a correct target (col 5, lines 50-59).
Regarding claim 6, Yuzhakov teaches a medical device comprising a plurality of first struts (see annotated figure 1) interconnected with a plurality of second struts (see annotated figure 1).
Yuzhakov fails to teach the details of the tubular substrate and the stretching. Marin teaches wherein the plurality of projections remain coincident relative to the substrate when the substrate is radially unstretched (col 2, line 40-col 3, line 15, fig 1), and wherein the plurality of projections extend radially outward when radial stretching of the substrate induces rotation of the struts (col 2, line 40-col 3, line 15, fig 2).
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 medical device taught by Yuzhakov by including a stretching activation method, as taught by Marin, in order to allow the medical device to have a controlled passive tissue protected state and tissue anchoring deployed state (col 1, lines 50-68, see fig 1 and 2).
Marin teaches further teaches wherein the substrate is a tubular substrate (see figure 1) and wherein the tubular substrate defines a lumen having a longitudinal axis (see figure 2). However Yuzhakov in view of Marin fails to teach the further details of fluid microneedle projections in a tubular substrate form. Melsheimer teaches a microneedle device (abstract) wherein the substrate is a tubular substrate (col 4, lines 15-29, a stent is tubular, or fig 6), wherein the tubular substrate defines a lumen having a longitudinal axis (col 4, lines 15-29, a stent has a lumen and longitudinal axis), wherein the plurality of projections remain coincident relative to the substrate (col 5, lines 29-49, passive configuration) and wherein the plurality of projections extend radially outward (col 5, lines 29-49, active configuration).
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 medical device taught by Yuzhakov by including a tubular substrate or stent form, as taught by Marin and Melsheimer, in order to allow the medical device to deliver an agent at a target site within the body (Melsheimer: col 4, lines 15-29).
Regarding claim 7, Yuzhakov fails to teach the details of the stretching. Marin teaches an improved stent (abstract) wherein the plurality of projections remain flat relative to the substrate when the substrate is longitudinally stretched and radially unstretched (col 2, line 40-col 3, line 15, 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 medical device taught by Yuzhakov by including a stretching activation method, as taught by Marin, in order to allow the medical device to have a controlled passive tissue protected state and tissue anchoring deployed state (col 1, lines 50-68, see fig 1 and 2).
Regarding claim 10, the combination of Yuzhakov, Marin and Melsheimer teaches a device wherein the medical device is configured to radially collapse (for example see Marin figure 1, structure is capable of radially collapsing) to draw together tissue surfaces captured by the plurality of projections (structure is capable of this, for example see col 6 line 59- col 7 line 3 in Yazuhakov, the combined device is capable of grasping tissue and is capable of collapsing so the structure can be used in this way, see reasons for combining art above).
Regarding claim 11, Yuzhakov fails to teach the details of a collar. Marin teaches further teaches wherein the substrate is a tubular substrate (see figure 1) and wherein the medical device further includes a collar configured to cover the lumen (col 1, graft material covers lumen). However, Yuzhakov in view of Marin fails to teach the further details of fluid microneedle projections in a tubular substrate form. Melsheimer teaches a microneedle device (abstract) wherein the substrate is a tubular substrate.
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 medical device taught by Yuzhakov by including a collared tubular substrate or stent form, as taught by Marin and Melsheimer, in order to allow the medical device to deliver an agent at a target site within the body (Melsheimer: col 4, lines 15-29).
Regarding claim 16, Yuzhakov fails to teach the exact details of a stent form. Marin teaches further teaches wherein the substrate is a stent (see figure 1). However, Yuzhakov in view of Marin fails to teach the further details of fluid microneedle projections in a stent form. Melsheimer teaches a microneedle device (abstract) wherein the substrate is a stent.
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 medical device taught by Yuzhakov by including a tubular substrate or stent form, as taught by Marin and Melsheimer, in order to allow the medical device to deliver an agent at a target site within the body (Melsheimer: col 4, lines 15-29).
Regarding claim 17, Yuzhakov fails to teach the exact details of a stent form. Marin teaches further teaches wherein the substrate further comprising a tubular graft layered with the substrate to form a stent graft (col 1). However, Yuzhakov in view of Marin fails to teach the further details of fluid microneedle projections in a stent form. Melsheimer teaches a microneedle device (abstract) wherein the substrate is a stent.
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 medical device taught by Yuzhakov by including a graft stent form, as taught by Marin and Melsheimer, in order to allow the medical device to deliver an agent at a target site within the body (Melsheimer: col 4, lines 15-29).
Claim(s) 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yuzhakov (US 7785301 B2) in view of Marin (US 5397355 A), Melsheimer (US 8764712 B2), and in further view of Bowe (WO 2007053791 A1).
Regarding claim 8, Yuzhakov fails to teach the details of the tubular substrate and the stretching. Marin further teaches wherein the substrate is a tubular substrate (see figure 1) and wherein the tubular substrate defines a lumen having a longitudinal axis (see figure 2), However Yuzhakov in view of Marin fails to teach the further details of fluid microneedle projections in a tubular substrate form. Melsheimer teaches a microneedle device (abstract) wherein the substrate is a tubular substrate (col 4, lines 15-29, a stent is tubular, or fig 6), wherein the tubular substrate defines a lumen having a longitudinal axis (col 4, lines 15-29, a stent has a lumen and longitudinal axis), wherein the plurality of projections remain coincident relative to the substrate (lines 29-49, passive configuration) when the substrate is longitudinally unstretched (col 5 lines 29-45, flat projections during delivery in passive configuration, activated by heat not stretching so capable of remaining flat) and wherein the plurality of projections can extend radially outward (lines 29-49, active configuration).
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 medical device taught by Yuzhakov by including a tubular substrate or stent form, as taught by Marin and Melsheimer, in order to allow the medical device to deliver an agent at a target site within the body (Melsheimer: col 4, lines 15-29).
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 medical device taught by Yuzhakov and Marin by including projections capable of remaining flat during longitudinal unstretching, as taught by Melsheimer, in order control drug delivery location and timing conditions as desired (col 4, lines 15-30).
Yuzhakov in view of Marin and Melsheimer does not exactly teach the longitudinal stretching during expansion, Bowe teaches a stent wherein during expansion the stent undergoes longitudinal stretching (abstract). The combination of Yuzhakov in view of Marin and Melsheimer and din further view of Bowe teaches wherein the plurality of projections extend radially when longitudinal stretching of the substrate induces rotation (note Marin teaches rotation during expansion for anchoring purposes, see above, and Bowe teaches longitudinal stretching during expansion, therefore the modified device is capable of this).
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 medical device taught by Yuzhakov in view of Marin and Melsheimer, by including longitudinal stretching, as taught by Bowe, in order to be able to conform to specific patient curvatures within the body (Bowe: abstract).
Regarding claim 9, Yuzhakov in view of Marin fails to teach the exact details of the flat projections during radial stretching. Melsheimer teaches a microneedle device (abstract) wherein the plurality of projections remain flat relative to the substrate (lines 29-49, passive configuration) when the substrate is radially stretched (col 5 lines 29-45, activated by heat not stretching so capable of being flat during radial stretching), and longitudinally unstretched (col 5 lines 29-45, flat projections during delivery in passive configuration, activated by heat not stretching so capable of remaining flat).
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 medical device taught by Yuzhakov and Marin by including projections capable of remaining flat during radial stretching and longitudinal unstretching, as taught by Melsheimer, in order control drug delivery location and timing conditions as desired (col 4, lines 15-30).
Claim(s) 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Yuzhakov (US 7785301 B2) in view of Marin (US 5397355 A) and Melsheimer (US 8764712 B2), and in further view of “JP” (JP 4282997 B2).
Regarding claim 12, Yuzhakov in view of Marin and Melsheimer fails to exactly teach the details of the self-expansion. JP teaches a stent wherein the tubular substrate is radially self-expandable ([0075]).
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 medical device taught by Yuzhakov in view of Marin and Melsheimer by applying the teachings of a self-expanding stent, as taught by JP, in order to complete a simple substitution of one known delivery method for another known in the art to obtain predictable results of effective implantation based on a patient’s needs; (MPEP 2143).
Regarding claim 13, Yuzhakov fails to teach the details of the balloon. Marin teaches further teaches wherein the substrate is a tubular substrate (see figure 1) and wherein the tubular substrate is radially balloon-expandable (col 2, lines 25-38). However, Yuzhakov in view of Marin fails to teach the further details of fluid microneedle projections in a tubular substrate form. Melsheimer teaches a microneedle device (abstract) wherein the substrate is a tubular substrate.
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 medical device taught by Yuzhakov by including a ballon expandable tubular substrate or stent form, as taught by Marin and Melsheimer, in order to allow the medical device to deliver an agent at a target site within the body (Melsheimer: col 4, lines 15-29).
Regarding claim 14, Yuzhakov further teaches wherein the plurality of projections rotate with the intermediate sections of the plurality of second struts to project outwardly relative) to the plurality of first struts (see annotated figure 1).
Yuzhakov fails to teach the change of states. Marin teaches the rotation of projections between the collapsed diameter and the expanded diameter (col 2, line 40-col 3, line 15, fig 1 and fig 2).
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 medical device taught by Yuzhakov by including a stretching activation method, as taught by Marin, in order to allow the medical device to have a controlled passive tissue protected state and tissue anchoring deployed state (col 1, lines 50-68, see fig 1 and 2).
Yuzhakov in view of Marin and Melsheimer fails to exactly teach the details of the self-expansion. JP teaches a stent wherein the tubular substrate is radially self-expandable to an intermediate diameter from a collapsed diameter and wherein the tubular substrate is radially balloon-expandable to an expanded diameter from the intermediate diameter ([0170], self-expanded to a first intermediate diameter then over-expanded to an expanded diameter to secure).
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 medical device taught by Yuzhakov in view of Marin and Melsheimer by applying the teachings of a self-expanding stent and balloon expansion, as taught by JP, in order to complete a simple substitution of one known delivery method for another known in the art to obtain predictable results of effective implantation and securing based on a patient’s needs; (MPEP 2143).
Regarding claim 15, Yuzhakov further teaches wherein the plurality of projections rotate with the intermediate sections of the plurality of second struts to project outwardly relative) to the plurality of first struts (see annotated figure 1).
Yuzhakov fails to teach the change of states. Marin teaches the rotation of projections between the collapsed diameter and the expanded diameter (col 2, line 40-col 3, line 15, fig 1 and fig 2), and further teaches the rotation of the projections from an internal force such as a balloon (col 2, line 40-col 3, line 15).
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 medical device taught by Yuzhakov by including a stretching activation via a balloon method, as taught by Marin, in order to allow the medical device to have a controlled passive tissue protected state and tissue anchoring deployed state (col 1, lines 50-68, see fig 1 and 2).
Yuzhakov in view of Marin and Melsheimer fails to exactly teach the details of the self-expansion. JP teaches a stent wherein the tubular substrate is radially self-expandable to an intermediate diameter from a collapsed diameter and wherein the tubular substrate is radially balloon-expandable to an expanded diameter from the intermediate diameter ([0170], self-expanded to a first intermediate diameter then overexpanded to an expanded diameter to secure). The combination of JP and Marin teaches wherein the plurality of projections remain flat relative to the substrate when the substrate expands from the collapsed diameter to the intermediate diameter (the collapsed to intermediate diameter would be self-expansion not balloon expansion, Marin teaches wherein the struts rotate from the balloon).
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 medical device taught by Yuzhakov in view of Marin and Melsheimer by applying the teachings of a self-expanding stent and balloon expansion, as taught by JP, in order to complete a simple substitution of one known delivery method for another known in the art to obtain predictable results of effective implantation and securing based on a patient’s needs; (MPEP 2143).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 8:30PM-4:30PM EST M-F (occasionally off Fridays).
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/H.L.P./Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774