DETAILED ACTION
This action is in response to applicant's preliminary amendments filed 04/18/25.
The examiner acknowledges the amendments to the claims and specification.
Claims 40-59 are pending in this application.
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 .
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 45, 47, 52-53, 57 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.
Both Claim 45, line 2 and Claim 47, line 3 recite “the surrounding of the device”. There is insufficient antecedent basis for this limitation in the claims. For examination purposes, the limitation will be read as --a surrounding of the device--.
Claim 52, line 1 recites “the gripping portion”. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, claim 52 will be read as being dependent on Claim 51 (which recites “a gripping portion” in line 2) rather than on Claim 50. Claim 53 is rejected due to its dependency on claim 52.
Claim 57 recites “a mark visible through a delivery device for identification of a deployment position”. It is unclear if “a delivery device” is being positively recited or is only functionally recited. The preamble recites “[t]he device of claim 40”, which is a “device for occluding a flow in a tubular organ”, rather than a combination of a device for occluding a flow in a tubular organ and a delivery device for said device for occluding a flow in a tubular organ. For examination purposes, the claim will be read as positively reciting the delivery device.
Claim Rejections - 35 USC § 102
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.
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.
Claims 40, 42, 44, 49, 56, 59 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wijay (U.S. Pub. No. 2017/0202702).
Regarding claim 40, Wijay discloses a device for occluding a flow in a tubular organ (see abstract), comprising:
a flexible frame (including segments 22, 28, 32 that can be compressed/expanded; Figures 2-4, [0033]-[0034]) reversibly expandable from a collapsed state to an expanded state (Id.);
a membrane 26 (Id.) supported, at least partially, by the flexible frame and being peripheral thereto (Id. and [0014]; the membrane lines the outside surface of the flexible frame such that it abuts the tissue in the tubular organ), the membrane being impermeable at least to selected types of biological matter ([0014], [0033]-[0034]; the membrane, or elastomeric sealing member 26, such as silicone, would be capable of sealing from reproductive cells such as sperm, or blood), the flexible frame and/or the membrane define an internal volume of the device (the flexible frame is hollow, as it is a tube; [0034]);
wherein in the expanded state (as in Figure 2), an external contour defines
a proximal portion 22 dimensioned to be larger in diameter than an opening of the tubular organ (Id.),
a distal portion 32 dimensioned to be anchored within the tubular organ, for sealing off the passage of any one of said biological matter (via membrane 26).
Regarding claim 42, Wijay discloses the distal portion is dimensioned to have a circumference larger than a portion of the tubular organ it is intended to be positioned in (Figure 4, [0037]; if the distal portion 22 is positioned in a tubular organ having a diameter smaller than a diameter [5-10 mm] of the distal portion, then the distal portion will have a larger circumference as claimed).
Regarding claim 44, Wijay discloses first portions of the external contour are defined by the membrane (see the portions of the flexible frame lined by membrane 26 in Figures 2-3) and second portions of the external contour are defined by the flexible frame (see the portions of the flexible frame that are not lined by membrane 26).
Regarding claim 49, Wijay discloses in its expanded state, the external contour defines an intermediate portion 28 (Id.) bridging the proximal portion 22 and the distal portion 32 defining a neck portion of the device;
wherein the device defines a longitudinal axis (along the length of the flexible frame), and said intermediate portion 28 maintains a minimal circumference in a plane normal to the longitudinal axis that is smaller than all circumferences of both the proximal and the distal ends defined between their two maximal circumferences in a plane normal to the longitudinal axis (Id. and Figure 4, [0037]).
Regarding claim 56, Wijay discloses the tubular organ 16 is any one of: a fallopian tube ([0033]), spermatic cord or a siphon in the lung.
Regarding claim 59, Wijay discloses a kit comprising:
an occluding device according to claim 40 (as discussed above);
a delivery device 40 (Figure 6; [0039]) for delivering and deploying the occluding device into the tubular organ 16.
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.
Claims 41 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Wijay (U.S. Pub. No. 2017/0202702) in view of Brohm-Schmitz-Rode (U.S. Pub. No. 2018/0369013).
Regarding claims 41 and 48, Wijay discloses the claimed invention, as discussed above, except for said proximal portion has at least one portion having a larger cross-sectional dimension than the distal portion, and wherein the device defines a longitudinal axis, the proximal portion comprises a maximal circumference in a plane normal to the longitudinal axis that is larger than a maximal circumference of the distal portion in a plane normal to the longitudinal axis.
In the same field of art, namely a device for occluding a flow in a tubular organ, Brohm-Schmitz-Rode teaches in an expanded state, an external contour of a device comprising a proximal portion (bell or funnel-shaped body 11 in Figure 4, for example) having at least one portion having a larger cross-sectional dimension than a distal portion (spindle-shaped body 7), and wherein the device defines a longitudinal axis, the proximal portion comprises a maximal circumference in a plane normal to the longitudinal axis that is larger than a maximal circumference of the distal portion in a plane normal to the longitudinal axis (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify Wijay such that said proximal portion is larger than the distal portion as claimed, as taught by Brohm-Schmitz-Rode, in order to help prevent and block dislocation of the device from the tubular organ ([0047]-[0048]; Brohm-Schmitz-Rode)
Claims 43 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Wijay (U.S. Pub. No. 2017/0202702) in view of Bastin (U.S. Pub. No. 2011/0160753).
Regarding claim 43, Wijay discloses the external contour is determined (in part) by said membrane 26 (Figures 2-3), however does not disclose the external contour is determined by the membrane.
In the same field of art, namely a device for occluding a flow in a tubular organ, Bastin teaches in Figures 1-3 an expandable/collapsible flexible frame 110 and a membrane 112 that determines the external contour of the device in an expanded state.
It would have been obvious to one of ordinary skill before the effective filing date to modify Wijay such that the external contour is determined by said membrane, as taught by Bastin, in order to extend over the entire flexible frame such that there is no direct communication between the interior of the device and the external environment (Bastin; ([0055]) to ensure occlusion of flow in the tubular organ.
Regarding claim 58, Wijay discloses the claimed invention, as discussed above, including wherein the types of biological matters are selected from reproductive cells, blood cells, species of bacteria, inflammation liquid and liquid from hydrosalpinx region.
(the membrane 26 is impermeable to the biological matters due to the membrane being made of silicone; [0014], [0033]-[0034]) but does not expressly teach membrane 26 is composed of a material inhibiting/reducing tissue growth (although Wijay teaches in [0002] and [0025] that the device does not depend on tissue growth within the fallopian tube to occlude the tubular organ).
Bastin further teaches a covering that may resist tissue ingrowth ([0037]). It would have been obvious to one of ordinary skill before the effective filing date to modify Wijay such that the membrane is composed of a material inhibiting/reducing tissue growth, as taught by Bastin, since Wijay does not rely on tissue growth within the fallopian tube to occlude the tubular organ, which takes time and is not very reliable in some instances ([0002] and [0025]; Wijay).
Claims 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over Wijay (U.S. Pub. No. 2017/0202702) in view of Odzil et al., hereinafter “Odzil” (U.S. Pub. No. 2015/0007827).
Regarding claims 45-47, Wijay discloses the claimed invention, as discussed above, except for the membrane comprises one or more openings to facilitate the exchange of fluids between the internal volume and the surrounding of the device, and wherein the membrane comprises a weak region formed at the distal portion configured to be ruptured upon exceeding a threshold pressure applied thereon, and wherein the membrane encompassing the proximal portion is formed with one or more openings to facilitate the exchange of fluids between the internal volume of the device and the surrounding of the device.
In the same field of art, namely a device for occluding a flow in a tubular organ, Odzil teaches a device comprising a membrane 204 comprises one or more openings (perforations 1216; Figure 12E, [0078]-[0079]) to facilitate exchange of fluids between an internal volume and a surrounding of the device. In Figure 12D and [0076] Odzil teaches membrane 204 comprises a weak region 1214 formed at a distal portion configured to be ruptured upon exceeding a threshold pressure applied thereon (Id.; pressure created by a cannulation member 1002, [0068]). Furthermore, Odzil teaches a membrane 204 (Figure 12E, [0078]-[0079]) encompassing a proximal portion being formed with one or more openings (perforations 1216) to facilitate the exchange of fluids between an internal volume of the device and a surrounding of the device.
It would have been obvious to one of ordinary skill before the effective filing date to modify Wijay with one or more openings or a weak region as claimed, as taught by Odzil, in order to allow reversal of the occlusion (Odzil; [0012], [0035], [0097]) if desired by the patient.
Claims 50-51, 54, 55 are rejected under 35 U.S.C. 103 as being unpatentable over Wijay (U.S. Pub. No. 2017/0202702) in view of McGuckin, Jr. et al., hereinafter “McGuckin” (U.S. Patent No. 7,179,275) and Tischler et al., hereinafter “Tischler” (U.S. Pub. No. 2014/0135817).
Regarding claim 50-51, 55, Wijay discloses the claimed invention, as discussed above, except for the proximal portion is formed with a depression, wherein the flexible frame comprises a protruding portion that protrudes from the depression, the device further comprising a gripping portion formed over said protruding portion for allowing gripping of the device, and wherein the depression is characterized by a longitudinal length L₁ and the protruding portion extends to a longitudinal length L₂, being shorter than L1.
Tischler teaches in Figures 11-12 a device for occluding flow in a tubular organ (see abstract) including a flexible frame 210, a membrane 230, and a proximal portion formed with a depression (leading inwards to protruding portion 212) wherein the flexible frame comprises a protruding portion 212 that protrudes from the depression, the device further comprising and wherein the depression is characterized by a longitudinal length L₁ and the protruding portion 212 extends to a longitudinal length L₂, being shorter than L1 (Id.; the protruding portion 212 is encompassed within the depression, and therefore is shorter than the depression), wherein the protruding portion 212 can be attached to a delivery shaft ([0049]).
Additionally, pertinent to the particular problem of allowing gripping of a device, McGuckin teaches a similarly structured device used in a tubular organ (Figure 15), including a flexible frame (including struts 14; Figure 2, abstract) with a proximal portion formed with a depression (see proximal portion between V1 and V2 in Figure 2 that is formed with a recess by angled portions 21), wherein the flexible frame comprises a protruding portion 18 that protrudes from the depression, the device further comprising a gripping portion (Figures 5A-5B, col. 9, lines 47-60; 18 can have a gripping portion 70 to allow retrieval or removal from the tubular organ) formed over said protruding portion for allowing gripping of the device (Id.), and wherein the depression is characterized by a longitudinal length L₁ (length between V1 and V2 in Figure 2) and the protruding portion 18 extends to a longitudinal length L₂, being shorter than L1 (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify Wijay with a depression and a protruding portion and gripping portion as claimed, as taught by Tischler and McGuckin, in order to facilitate repositioning or removal of the device from the body (McGuckin; col. 9, lines 47-60) when the occlusion is no longer needed or desired.
Regarding claim 54, Wijay as modified teaches the claimed invention, as discussed above, except for a proximal end of the protruding portion or a portion of
the gripping portion are covered by a soft covering material. However, Wijay teaches teaches covering portions of the device with a soft covering material, such as silicone ([0018]), which is known in the art for its biocompatibility. It would have been obvious to one of ordinary skill before the effective filing date to modify a proximal end of the protruding portion or a portion of the gripping portion to be covered by a soft covering material, as taught by Wijay, in order to maintain a smooth, biocompatible surface (Id.) throughout the device.
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Wijay (U.S. Pub. No. 2017/0202702) in view of McGuckin (U.S. Patent No. 7,179,275) and Tischler (U.S. Pub. No. 2014/0135817), as applied to claim 51 above, and further in view of Townsend et al., hereinafter “Townsend” (U.S. Pub. No. 2008/0178890).
Regarding claim 52, Wijay as modified teaches the claimed invention, as discussed above, except for the gripping portion comprises a first sleeve that fits
over the protruding portion.
In the same field of art, namely a device for occluding a flow in a tubular organ, in Figures 2-3 Townsend teaches a protruding portion 126/127 and a gripping portion 124/128 formed over said protruding portion for allowing gripping of the device (Figure 12, [0042]), and the gripping portion comprising a first sleeve 124 that fits over (above) the protruding portion.
It would have been obvious to one of ordinary skill before the effective filing date to modify the gripping portion to comprise a first sleeve as claimed, as taught by Townsend, in order to create a structure that facilitates securely holding the device during repositioning and/or removal (Townsend; [0031]) and since doing so would be substitution of one known gripping portion for another, which would yield predictable results, namely facilitating manipulation and repositioning/removal of the device. See MPEP 2143.
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Wijay (U.S. Pub. No. 2017/0202702) in view of Townsend (U.S. Pub. No. 2008/0178890).
Regarding claim 57, Wijay discloses the claimed invention, as discussed above, except for a mark visible through a delivery device for identification of a deployment position.
In the same field of art, namely a device for occluding a flow in a tubular organ, Townsend teaches in Figures 6-8, [0040]-[0041] a mark 15 visible through a delivery device 10 for identification of a deployment position (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify Wijay with a mark visible through a delivery device for identification of a deployment position, as taught by Townsend, in order to facilitate proper placement and delivery of the device (Id.).
Allowable Subject Matter
Claim 53 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
None of the prior art of record, alone or in combination, teaches or renders obvious a device for occluding flow in a tubular organ including, inter alia, a flexible frame having an expanded state, a membrane supported, at least partially, by the flexible frame, wherein in the expanded state, an external contour defines a proximal portion, the proximal portion defining a depression and a protruding portion that protrudes from the depression, and a gripping portion formed over said protruding portion and comprising a first sleeve that fits over the protruding portion, wherein the gripping portion comprises a second sleeve that fits over the first sleeve such that a gap is formed between the first sleeve and the second sleeve for allowing a gripping element of a gripping device to be received therein; wherein a distal end of the second sleeve is cut in a profile improving the grip of the gripping element.
As discussed above, Townsend (U.S. Pub. No. 2008/0178890) teaches a device for occluding flow in a tubular organ including a protruding portion 126/127 and a gripping portion 124/128 formed over said protruding portion for allowing gripping of the device (Figure 12, [0042]), and the gripping portion comprising a first sleeve 124 that fits over (above) the protruding portion, however does not teach or render obvious having a second sleeve that fits over the first sleeve such that a gap is formed for allowing gripping as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771
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