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 .
Response to Amendment
This Office action is in response to the applicant’s communication filed 09/03/2026.
Status of the claims:
Claims 1 – 22 are pending in the application.
Claims 1, 3 – 6, 8 – 10, 14, 17, and 18 are amended.
Drawings
The drawings were received on 09/03/2026. These drawings are accepted.
Claim Objections
The objections to claims 3 –6, 8, 10, 14, and 18 in the previous action dated 06/03/2026 have been withdrawn in light of the Applicant’s amendments filed 09/03/2026. Specifically, the objection to claim 3 regarding the phrases “adjacent struts”, “a proximal diameter”, and “a distal diameter”, the objection to claim 4 regarding the phrase “struts of circumferentially adjacent rows of struts”, the objection to claims 5 and 8 regarding the phrase “the expandable element”, the objection to claim 6 regarding the phrase “membrane captures the fluid when”, the objection to claim 10 regarding the phrase “a proximal side”, the objection to claim 14 regarding the phrase “embolic implant according with”, and the objection to claim 18 regarding the phrase “an embolic implant” have all been withdrawn as the appropriate corrections have been made. However, new objections have been set forth below in light of Applicant’s amendments.
Claim 1 is objected to because of the following informalities:
Claim 1 recites “a collapsed intermediate diameter” in line 11, although the line is understood by the Examiner to mean “the collapsed intermediate diameter” as all of the elements were previously defined, the Examiner suggests the line be amended to read “the collapsed intermediate diameter” for the purpose of maintaining consistent language throughout the claims;
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.
The rejection of claims 9 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 06/03/2026 have been withdrawn in light of the Applicant’s amendments filed 09/03/2026. Specifically, the rejection of claim 9, regarding the lack of clarity in the phrase "a plurality of openings", has been withdrawn as the appropriate corrections have been made.
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 1 – 4, 6 – 7, 10 – 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jancaric et al (US 2019/0262001 A1) (previously recited).
Regarding claim 1, Jancaric discloses an embolic implant (occlusive medical device 10) (abstract, paragraphs [0020], [0043], [0044], and Figs. 1 – 7), comprising:
a tube (laser cut tube 40) comprising:
a distal end (end 22) and a proximal end (end 25) (paragraph [0045] and Fig. 1) (Examiner’s note: the terms “proximal” and “distal” are relative terms related to the orientation of the object; and as stated in paragraph [0045] the disclosure’s reference to “proximal” and “distal” is merely illustrative, and the device can be used in any orientation, such that the proximal end 22 is the distal end and the distal end 25 is the proximal end; therefore, for the Examiner has designated the claimed distal end as the disclosed “proximal end 22” and the claimed proximal end as the disclosed “distal end 25” for sake of the rejection);
an expandable section (frame 12) between the distal end and the proximal end (paragraph [0045] and Figs. 1 – 7) and having:
a collapsed state (collapsed configuration) (paragraphs [0045], [0056], [0068], and Fig. 2) in which the expandable section has an intermediate diameter (diameter shown in Fig. 2) that is substantially the same as a proximal diameter of the proximal end and a distal diameter of the distal end (diameters of the ends 25 and 22, respectively, Figs. 1 and 2); and
an expanded state (expanded state – shown in Fig. 1) in which the proximal diameter of the proximal end and the distal diameter of the distal end remain substantially unchanged (Fig. 1) while the intermediate diameter of the expandable section (frame 12) increases (Fig. 1); and
a membrane (membrane 20) covering a distal side (region 14) of the expandable section (frame 12) (Fig. 1) (Examiner’s note: as stated above, the Examiner is interpreting the “proximal” end Jancaric as the “distal” end and vice versa; therefore, under the Examiner’s interpretation, the region 14 is considered the “distal” region and the region 16 is considered the “proximal” region),
the membrane expandable upon expansion of the expandable section to the expanded state (paragraphs [0044 – 0045] and Fig. 1), and including at least one opening on a proximal side (side from the large diameter end of the membrane 20 to the end 25) of the expandable section (frame 12) that allows fluid to flow into the expandable section and against an inner surface of the membrane (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the membrane 20, as discussed in paragraphs [0047 – 0048], has an open end which allows it to expand with increased pressure of fluid flow therethrough and is expandable to extend across the vessel lumen to completely block / occlude the fluid blood / fluid flow through the vessel).
Regarding claim 2, Jancaric discloses wherein the expandable section (frame 12) of the tube (laser cut tube 40) includes a plurality of cuts (cuts 50) that define a plurality of struts (struts 52 / struts 18) (paragraph [0053] and Figs. 2 – 6).
Regarding claim 3, Jancaric discloses wherein:
in the collapsed state (collapsed configuration – Fig. 2), circumferentially adjacent struts of the plurality of struts are positioned adjacent to each other to impart the expandable section with the collapsed intermediate diameter (Fig. 2); and
in the expanded state (expanded configuration – Fig. 1), the circumferentially adjacent struts are spaced apart from each other to increase the diameter of the expandable section to the expanded diameter (Fig. 1).
Regarding claim 4, Jancaric discloses wherein the plurality of struts (struts 52 / struts 18) comprises a plurality of rows of struts extending along a length of the tube (Fig. 2), struts of circumferentially adjacent rows of struts being longitudinally offset from each other (Fig. 2).
Regarding claim 6 and 7, Jancaric discloses [claim 6] wherein the membrane (membrane 20) is configured to capture the fluid when the expandable section is in the expanded state and [claim 7] wherein a configuration of the membrane (membrane 20) in combination with fluid pressure exerted from the proximal portion toward the distal portion of the expandable section enables the embolic implant to be secured at a desired location along a length of a vessel (Examiner’s note: the preceding limitations are intended use limitations which require only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the membrane 20, as discussed in paragraphs [0047 – 0048], has an open end and a closed end which allows it to capture fluid flow therethrough and is expandable to extend across the vessel lumen to completely block / occlude the fluid blood / fluid flow through the vessel, thereby enabling itself to be secured along the vessel).
Regarding claim 10, Jancaric discloses wherein the membrane (membrane 20) does not cover the proximal side (side from the large diameter end of the membrane 20 to the end 25) of the expandable section (frame 12) (Fig. 1).
Regarding claim 11, Jancaric discloses wherein the expandable section (frame 12) and the membrane (membrane 20) are retractable (Examiner’s note: there is nothing that prevents the device 10, which includes the frame 12 and membrane 20, from being retracted; therefore, the device 10 is considered retractable).
Regarding claim 12, Jancaric discloses further comprising: a coupler (tubular portion at the end 25 – shown in Fig. 1) on the proximal end (end 25) of the tube (laser cut tube 40) to facilitate coupling and uncoupling of the embolic implant to a delivery device (paragraph [0046]).
Regarding claim 14, Jancaric an embolic system (occlusive medical device 10) (abstract, paragraphs [0020], [0043], [0044], and Figs. 1 – 7), comprising:
a delivery system (sheath and pull wire) (paragraphs [0046] and [0068]) including:
a wire (pull wire) (paragraphs [0046] and [0068]); and
a detachment device (distal end of the pull wire) at a distal end of the wire (paragraph [0046]); and
an embolic implant (occlusive medical device 10) with a proximal end (end 25) engageable and disengageable by the detachment device of the delivery system (paragraph [0046]) (Examiner’s note: as stated in paragraph [0046] the end of the wire is releasably secured to the end 25; therefore, the end of the wire is a detachment device as it releases the end 25 of the medical device 10 and the proximal end 25 is engageable / disengageable with the end of the wire (i.e., the detachment device), the embolic implant including:
a tube (laser cut tube 40) comprising:
a distal end (end 22) and a proximal end (end 25) (paragraph [0045] and Fig. 1) (Examiner’s note: as stated in paragraph [0045] the disclosure’s reference to “proximal” and “distal” is merely illustrative, and the device can be used in any orientation, such that the proximal end 22 is the distal end and the distal end 25 is the proximal end; therefore, for the Examiner has designated the claimed distal end as the disclosed “proximal end 22” and the claimed proximal end as the disclosed “distal end 25” for sake of the rejection);
an expandable section (frame 12) between the distal end and the proximal end (paragraph [0045] and Figs. 1 – 7) and having:
a collapsed state (collapsed configuration) (paragraphs [0045], [0056], [0068], and Fig. 2) in which the expandable section has an intermediate diameter (diameter shown in Fig. 2) that is substantially the same as a proximal diameter of the proximal end and a distal diameter of the distal end (diameters of the ends 25 and 22, respectively, Figs. 1 and 2); and
an expanded state (expanded state – shown in Fig. 1) in which the proximal diameter of the proximal end and the distal diameter of the distal end remain substantially unchanged (Fig. 1) while the intermediate diameter of the expandable section (frame 12) increases (Fig. 1); and
a membrane (membrane 20) covering a distal side (region 14) of the expandable section (frame 12) (Fig. 1) (Examiner’s note: as stated above, the Examiner is interpreting the “proximal” end Jancaric as the “distal” end and vice versa; therefore, under the Examiner’s interpretation, the region 14 is considered the “distal” region and the region 16 is considered the “proximal” region),
the membrane expandable upon expansion of the expandable section to the expanded state (paragraphs [0044 – 0045] and Fig. 1), and including at least one opening on a proximal side (side from the large diameter end of the membrane 20 to the end 25) of the expandable section (frame 12) that allows fluid to flow into the expandable section and against an inner surface of the membrane (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the membrane 20, as discussed in paragraphs [0047 – 0048], has an open end which allows it to expand with increased pressure of fluid flow therethrough and is expandable to extend across the vessel lumen to completely block / occlude the fluid blood / fluid flow through the vessel).
Claims 1 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Forber (US 6,221,086 B1) (previously cited).
Regarding claim 1, Forber discloses an embolic implant (vascular occlusion 300) (abstract, col. 2 lines 46 – 67, col. 9 line 40 – col. 10 line 7, and Figs. 1,17,18), comprising:
a tube (tube made out of wires 22 – shown in Fig. 1, described in col. 9 lines 40 – 67) comprising:
a distal end (distal band – opposite proximal band 330 – Fig. 17, 18) and a proximal end (proximal band 330) (col. 9 line 40 – col. 10 line 7 and Figs. 17 – 18);
an expandable section (central section between proximal and distal ends – shown in Fig. 17; discussed in col. 5 lines 17 – 20) between the distal end and the proximal end (Figs. 1,17,18) and having:
a collapsed state (collapsed configuration) in which the expandable section has a collapsed intermediate diameter that is substantially the same as a proximal diameter of the proximal end and a distal diameter of the distal end (Examiner’s note: although not shown, because the occlusion device is made out of a self-expandable material, it is compressible and therefore has a collapsed intermediate diameter. Additionally, because both the proximal and distal ends are comprised of the same nitinol wires, the expandable section is capable of collapsing to a collapsed diameter that is “substantially the same” (i.e., relatively close to) as that of the proximal and distal ends under enough pressure. Therefore, it is said that Forber discloses the limitation above); and
an expanded state (expanded state – shown in Fig. 17) in which the proximal diameter of the proximal end and the distal diameter of the distal end remain substantially unchanged (Figs. 1, 17, 18) while the intermediate diameter of the expandable section (central section between proximal and distal ends) increases (Fig. 1,17,18); and
a membrane (film 320) covering a distal side of the expandable section (Examiner’s note: although, the film 320 is disclosed as being the proximal side, Figs. 17 and 18 show the proximal side looking the exact same as the distal side (openings aside), therefore, the Examiner contends that Figs. 17 and 18 shows the film 320 covering both the proximal and distal sides of expandable section), expandable upon expansion of the expandable section to the expanded state (Fig. 17, 18), and including at least one opening on a proximal side (proximal side 350) of the expandable section that allows fluid to flow into the expandable section and against an inner surface of the membrane (col. 8 line 66 – col. 9 line 15, col. 10 lines 1 – 7, and Figs. 17,18);
[claim 9] wherein the membrane includes a plurality of openings (holes 340) on the proximal side (proximal side 350) of the expandable section (col. 10 lines 1 – 7 and Figs. 17,18).
Claim Rejections - 35 USC § 103
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 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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Jancaric et al (US 2019/0262001 A1) (previously cited) as applied to claim 4 above, and further in view of Fojtik (US 2022/0183693 A1) (previously cited).
Regarding claim 5, as discussed above, Jancaric discloses the embolic implant of claim 4 above.
However, Jancaric is silent regarding (i) wherein the plurality of struts rotate upon expansion of the expandable element.
As to the above, Fojtik teaches, in the same field of endeavor, an embolic implant (occlusive device 10’) comprising a tube (hypotube) with a distal end, proximal end, and expandable section comprised of a plurality of struts that rotate upon expansion of the expandable section (abstract, paragraphs [0014 – 0016], [0074], and Figs. 9A-9C) for the purpose of enabling the occlusive device to engage the tissue (i.e., the blood vessel).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the plurality of struts of Jancaric to rotate upon expansion of the expandable element, based on the teachings of Fojtik, for the purpose of enabling the occlusive device to engage the tissue (i.e., the blood vessel) (paragraph [0074] – Fojtik).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Jancaric et al (US 2019/0262001 A1) (previously cited) as applied to claim 1 above, and further in view of McGuckin, Jr. et al (US 2016/0346453 A1) (previously cited).
Regarding claim 8, as discussed above, Jancaric discloses the embolic implant of claim 1 above. Additionally, Jancaric discloses wherein the expandable element comprises a shape memory alloy (Nitinol) (paragraph [0057]).
However, Jancaric is silent regarding (i) wherein the shape memory alloy (Nitinol) transitions from the collapsed state to the expanded state upon exposure to body temperature.
As to the above, McGuckin, Jr. teaches a vascular occlusion device (vascular device 10; which equates to the occlusive medical device 10 of Jancaric) comprising an expandable element (support structure 12; which equates to the frame 12 of Jancaric) comprised of shape memory material that transitions from the collapsed state to the expanded state upon exposure to body temperature (abstract, paragraphs [0018], [0036], and Figs. 1 – 2).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the expandable element of Jancaric to comprise a shape memory alloy that transitions from the collapsed state to the expanded state upon exposure to body temperature, based on the teachings of McGuckin, Jr., as it is a known biocompatible material with a known means of expanding said material known to be used within the vasculature, and one of ordinary skill in the art would have a reasonable expectation of success in modifying the Nitinol to be expandable via exposure to body temperature, and the results would have been obvious and resulted in the expandable element being able to expand at the desired location as intended.
Claims 13 and 15 – 16 are rejected under 35 U.S.C. 103 as being unpatentable over Jancaric et al (US 2019/0262001 A1) (previously cited) as applied to claims 12 and 14 above, and further in view of Strauss et al (US 2012/0330348 A1) (previously cited).
Regarding claim 13, as discussed above, Jancaric discloses the embolic implant of claim 12 above. Additionally, does disclose, in paragraph [0046], securing a pull wire to the proximal end of the implant for the purpose of delivering the embolic implant.
However, Jancaric is silent regarding (i) wherein the coupler comprises a threaded coupler.
As to the above, Strauss teaches, in the same field of endeavor, an embolic implant (embolic implant 1500) comprising a distal end (distal end 102), a proximal end (proximal end 1510), an expandable section (wire frame structure / bars 104) extending therebetween, a threaded coupler (proximal end tubular portion with internal threads 1516) (abstract, paragraphs [0043], [0082], and Fig. 28).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the coupler of Jancaric to be a threaded coupler, based on the teachings of Strauss, for the purpose of being able to threadedly engage a threaded delivery catheter, so that the operator can release the embolic implant so that it can expand (paragraph [0005]).
Regarding claims 15 and 16, as discussed above, Jancaric discloses the embolic implant of claim 14 above. Additionally, does disclose, in paragraph [0046], securing a pull wire to the proximal end of the implant for the purpose of delivering the embolic implant.
However, Jancaric is silent regarding (i) [claim 15] wherein the detachment device engages and disengages a complementary coupler of the embolic implant and (ii) [claim 16] wherein the detachment device and the coupler are threaded.
As to the above, Strauss teaches, in the same field of endeavor, an embolic system (delivery catheter 210 and embolic implant 1500) comprising a delivery system (delivery catheter 210) including a wire (delivery catheter 210; which equates to the pull wire of Jancaric) and a detachment device (external threads 1502) at a distal end of the wire, an embolic implant (embolic implant 1500) comprising a distal end (distal end 102), a proximal end (proximal end 1510) with a complementary threaded coupler (proximal end tubular portion with internal threads 1516) that is engageable and disengageable with the detachment device, an expandable section (wire frame structure / bars 104) extending therebetween (abstract, paragraphs [0005 – 0006], [0043], [0082], and Fig. 28).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the coupler of Jancaric to be a complementary threaded coupler with external threads on the detachment device, based on the teachings of Strauss, as complementary threaded connections between two releasably connected parts that are intended to be releasably secured to each other is known (paragraph [0005] - Strauss); and one of ordinary skill in the art would have a reasonable expectation of success in threadedly connecting the pull wire and the embolic implant of Jancaric such that the results of the modification would have been predictable and resulted in the modified device being able to operate as intended.
Claims 17 – 22 are rejected under 35 U.S.C. 103 as being unpatentable over Kroeger et al (US 2020/0000476 A1) (previously cited) and in view of Fojtik (US 2022/0183693 A1) (previously cited).
Regarding claims 17 – 19, Kroeger discloses a method for positioning an embolic implant (vascular occlusion device) within a vessel (vessel 10) (abstract, paragraphs [0044], [0047], and Figs. 1 – 5), comprising:
advancing an embolic implant (occlusion device) with an expandable section (self-expanding frame 100) and a membrane (occlusive membrane 430) exterior to a distal portion (portion from the distal hub 110 to the open end of the occlusive membrane 430) of the expandable section to a desired location within the vessel (paragraphs [0047], [0070], [0071], and Fig. 5) (Examiner’s note: paragraph [0047] recites wherein the occlusion device / self-expanding frame is delivered to the treatment site; therefore, the disclosure encompasses the step of advancing the embolic implant (occlusion device) to a desired location. Additionally, paragraph [0070] recites wherein the portion of the self-expanding frame from the open end of the occlusive membrane 430 toward the closed end of the occlusive membrane 430, is embedded within the occlusive membrane 430. Therefore, there the membrane 430 is exterior to the distal portion);
expanding the expandable section and the membrane to an expanded state (paragraph [0047] and Fig. 5);
allowing a flow to flow into a proximal portion of the expandable section (self-expandable frame 100) and into an interior of the membrane (membrane 430) (paragraph [0055]), a resulting fluid pressure within the interior of the membrane securing the membrane and the expandable section in place along a length of the vessel (paragraph [0055]).
However, Kroeger is silent the regarding the step of (i) [claims 17 and 18] advancing the embolic implant coupled to a distal end of a delivery wire of a delivery system, (ii) [claim 17] positive recitation of expanding the expandable section, (iii) [claim 17] releasing the embolic implant from the delivery system, and (iv) [claim 19] wherein releasing the embolic implant comprises causing a detachment device of the delivery system at the distal end of the delivery wire to release a coupler on a proximal end of the embolic implant.
As to the above, Fojtik teaches, in the same field of endeavor, a method for positioning an embolic implant (occlusive device 10) within a vessel comprising the steps of advancing the embolic implant (occlusive device 10) coupled to a distal end of a delivery wire (control wire 210) through the lumen of a delivery system (delivery device 200), expanding the embolic implant (occlusive device 10), releasing the embolic implant (occlusive device 10) by causing a detachment device (distal end 212) at the distal end of the delivery wire (control wire 210) to release a coupler (proximal end of the occlusive device 10) on a proximal end of the embolic implant (abstract, paragraphs [0018], [0098 – 0106], and Figs. 14A – 15H).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method and system of Kroeger to incorporate the method steps above and further include the delivery system, as taught by Fojtik, for the purpose of being able to deliver the embolic implant of Kroeger into the vessel at the desired location.
Regarding claims 20 and 21, as discussed above, it would have been obvious to modify the method and system of Kroeger to incorporate the delivery system of Fojtik. Additionally, Kroeger makes obvious the desire to recapture the embolic implant with the delivery system, and reposition the embolic implant to a second location within the vessel, and then redeploy the embolic implant (paragraph [0055]) for the purpose of overcoming vessel spasms due to immediate occlusion. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method steps of Kroeger in view of Fojtik to further include the steps of recapturing, repositioning, and redeploying the implant to a secondary location for the purpose of overcoming vessel spasms due to immediate occlusion (paragraph [0055] – Kroeger).
Regarding claim 22, as discussed above, Kroeger and Fojtik teach the method of claim 20. Additionally, Kroeger teaches in paragraph [0044] wherein the vascular occlusion device (i.e., the embolic implant) is used for shutting off blood flow prior to organ resection, and in order to restore the normal blood flow through the vasculature after the organ resection the vascular occlusion device must be removed. Therefore, It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method and system of Kroeger in view of Fojtik to incorporate the method step of removing the embolic implant from the vessel for the purpose of restoring blood flow to the vasculature after the procedure is completed.
Response to Arguments
Applicant's arguments filed 09/03/2026 have been fully considered but they are not persuasive. More specifically:
With respect to Applicant’s argument that “While Jancaric describes that the membrane 20 may cover the proximal end of the frame 12, Jancaric does not expressly or inherently describe that the membrane 20 may cover the distal end of the frame 12, as would be needed for Jancaric to anticipate the embolic implant of claim 1 or the embolic system of claim 14”, as stated in the rejection of claims 1 and 14 above, Jancaric discloses wherein the implant can be used in any orientation, meaning that the disclosed proximal end is also a distal end and vice versa. Therefore, based on the Examiner’s interpretation, Jancaric does disclose wherein the membrane 20 covers the distal end as the distal end is the equivaled to the disclosed proximal end.
With respect to Applicant’s argument that “Forber does not expressly or inherently describe that a tube includes the shapeable, or expandable, portion of the vascular occlusion device” and “The description of Forber is limited to films on the proximal sides of vascular occlusive devices. Forber lacks any express or inherent description of a vascular occlusive device with a film on the distal side of an expandable element”, the Examiner respectfully disagrees, the device of Forbes is disclosed as being made of Nitinol wires; and Nitinol makes the system compressible and thus expandable from the compressed state. Furthermore, as shown in Figs. 17 and 18 of Forbes, the distal region looks the exact same as the proximal region, which is disclosed as having the film 320, therefore, the Examiner contends that the distal region also has the film 320 extending along the length thereof. Therefore, Applicant’s arguments are not persuasive.
With respect to Applicant’s arguments that “Kroeger does not teach or suggest that the membrane 130 is exterior to the self-expanding frame 100”, it should be understood that the Examiner is relying on the membrane 430, not membrane 130; furthermore, Kroeger discloses in paragraph [0070], that the distal portion of the frame 100 is embedded within the membrane 430; the term “embedded” is defined as “fixed inside a surrounding substance”, thus, the frame is on the inside of the surrounding membrane 430 and the membrane 430 is on the exterior of the frame 100. The Examiner notes that the claims as currently written do not require the membrane to be only on the exterior surface of the frame. Therefore, Applicant’s arguments are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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