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 responsive to the amendment filed on 10/17/2025. As directed by the amendment: claims 1, 7-11 have been amended, claims 18-20 have been cancelled and claims 21 has been added. Thus, claims 1-17 and 21 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 6, filed 10/17/2025, with respect to the drawing objections have been fully considered and are persuasive. The applicant’s amended drawings overcome the objections. The drawing objections have been withdrawn.
Applicant’s arguments, see page 6, filed 10/17/2025, with respect to USC 112(f) claim interpretation have been fully considered and are persuasive. Claim 7 no longer invokes USC 112(f) due to the amendment to recite “a radioactive source” instead of “an element configured to stimulate a closure of an aneurysm”.
Applicant's arguments, see pages 7-9, filed 10/17/2025, with respect to the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Lorenzo (US 20190192167 A1), herein referenced to as “Lorenzo” have been fully considered but they are not persuasive.
The applicant has amended claim 1 to further recite “wherein in the expanded configuration the expandable body centrally protrudes proximally away from the base; and a holder designed to connect to a push-wire for delivery of the intravascular device, the holder centrally disposed at an apex of the central protrusion, wherein in use, when the intravascular device is deployed in an aneurysm the central protrusion protrudes proximally into a blood vessel”.
The applicant asserts that Lorenzo does not disclose the amended language and that it instead teaches away from the amended claim language, particularly “when the intravascular device is deployed in an aneurysm the central protrusion protrudes proximally into a blood vessel”. The applicant cites [0080] of Lorenzo, and the section “Expanded segments, 12 13 and positioning mechanism 9 into the braid 10 is particularly advantageous as it can prevent braid 10 from creating a protrusion that would otherwise extend into the parent vessel. Instead, any such protrusion can now be tucked into segment 12 and/or 13 of braid 10.” This however, is a recitation of a preferred embodiment and not an explicit teaching against a central protrusion protrudes proximally into a blood vessel.
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994)
Instead, in light of the figures, especially Fig. 9 of Lorenzo, paragraph [0080] is meant to describe a bunching of the braid creating an unintended extension/protrusion from the desired shape of the device. As can be seen in Fig. 9 of Lorenzo, annotated below for reference, the deployed has a centrally protruding portion of 12 that when deployed protrudes proximally into a blood vessel.
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Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-17 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim limitation “wherein in use, when the intravascular device is deployed in an aneurysm the central protrusion protrudes proximally into a blood vessel” does not have adequate support in the applicant’s figures and specification. The applicant cited page 27, lines 18-22 and 28-30, page 57, lines 19-20, page 58, lines 5-6 and Figs. 34, 39B, 41A, 42C, 43A, 44A, and 45E as to giving support to this limitation. However, there is no clearly indicated or marked “central protrusion protrudes proximally into a blood vessel”. Furthermore, the preferred embodiment mentioned in the applicant’s specification indicates recessing elements into the device away from the flow of blood within the main vessel (see [0301] of applicant’s patent application publication, “In some embodiments, recessing of a portion to which the source is connected (e.g. base and/or top) moves connection of the source closer to a center of the device walls. A potential advantage of recessing connection of the source to the body is reduced disruption of the source connection to blood flow within the main vessel to which the aneurysm is a deformity.”). As such the limitation “wherein in use, when the intravascular device is deployed in an aneurysm the central protrusion protrudes proximally into a blood vessel” fails to comply with the written description requirement.
Claims 2-17 and 21 are rejected as being dependent on claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 12-17, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lorenzo (US 20190192167 A1), herein referenced to as “Lorenzo”.
Claim 1
Lorenzo discloses: An intravascular device 10 (see Figs. 1A-5B, [0078]) having a relaxed expanded configuration (see Figs. 2-3, [0068] and [0074]), comprising: an expandable body 12 (see Figs. 1A-5B, [0078]) having an expanded configuration (see Fig. 5B, [0080], expanded configuration) and a contracted configuration (see Fig. 1B, [0062], a collapsed configuration for delivery), said expandable body 12 in said expanded configuration (see Fig. 5B) having a convex curved shape (see Fig. 5B, 12 has a convex curved shape) having a base the base of 12 at the proximal end 16 of 10 (see Fig. 5B) and walls the walls of 12 that extend distally from the base of 12 (see Fig. 5B), said expandable body 12 comprises a proximal end 16 (see Fig. 5B, [0062]), and a distal end 14 (see Fig. 5B, [0062]), wherein said base the base of 12 is at 16 is disposed at said proximal end 16, and said walls the walls of 12 extend distally from the base of 12 which is at 16 (see Fig. 2-3 and 5B) extend distally from said base the base of 12 at 16; a support 13 (see Figs. 5A-5B, [0062]) which provides a second layer (see Figs. 5A-5B, 13 overlaps at portions over the neck of the aneurysm, providing a second or double layer) to at least a portion the support provides a double layer to both the walls and the base of 12 of said expandable body 12 including said base the base of 12 is at 16, said walls the walls of 12 have a double layer with 13 (see Figs. 5A-5B), a connector 44 (see Figs. 1A-5B, [0062]) disposed at said proximal end 16 of said expandable body 12 and connecting proximal ends the proximal ends of the walls of 12 are connected by 44 (see Fig. 5B) of said walls, wherein distal ends the distal ends of 12 at 14 are not connected (see Fig. 5B) of said walls are not connected, wherein in the relaxed expanded configuration (see Figs. 2-3) a cross section the cross-section of the walls of 12 formed by plane segments of the circumference of 12 (see Figs. 2-3, these cross-sections of the walls of 12 by taking plane segments of the circumference increases more from the proximal end 16 to the distal end 14, this interpreted is consistent with applicant’s explanation see [0321] of applicant’s PGPUB that it is the overall width of the expandable body that increases along its length rather than the thickness of the walls) of said walls increases along a length the length of the walls of 12 (see Figs. 2-3) of said walls, wherein in the expanded configuration (see annotated Fig. 9 below) the expandable body 12 centrally protrudes proximally (see annotated Fig. 9 below) away from the base the base of 12 is at 16; and a holder 54 (see Figs. 1-2, [0070]) designed to connect to a push-wire (see [0070], 54 can be attached to a pushing apparatus, including a push tube) for delivery of the intravascular device 1 (see [0070]), the holder 54 centrally disposed at an apex the apex of the central protrusion is the base, 16, which 54 attaches to (the definition of apex being according to Merriam-Webster online dictionary as “the uppermost point”) of the central protrusion, wherein in use (see Fig. 9), when the intravascular device 1 is deployed in an aneurysm A (see Fig. 9) the central protrusion (see annotated Fig. 9 below) protrudes proximally into a blood vessel BV (see annotated Fig. 9 below).
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Claim 2
Lorenzo discloses: The device according to claim 1, see 102 rejection above. Lorenzo further discloses: wherein said cross section the cross-section of the walls of 12 formed by plane segments of the circumference of 12 of said walls the walls of 2 increases by at least 2 times (see Figs. 2-3, the width as formed by the cross section of the device increase greater than two times along a length of the wall, from at 16 to at 14) along said length of said walls.
Claim 3
Lorenzo discloses: The device according to claim 1, see 102 rejection above. Lorenzo further discloses: wherein said expandable body 12 and said support 13 form a cup shape (see Figs. 2-3, 12 and 13 form a cup shape, as they have a single open end with walls and a base bottom), or a flattened cup shape (see Figs. 2-3, 12 and 13 both form flatten cup shapes per applicant’s description that a flattened cup shape is formed when the cross section of the walls of the device increases rapidly, to at least double along the wall length, which both 12 and 13 meet, with 12 increasing to multiple times by the distal end 14 and 13 increasing by multiple times by at least midway up the length of its walls).
Claim 4
Lorenzo discloses: The device according to claim 1, see 102 rejection above. Lorenzo further discloses: wherein said walls the walls of 12 + 13 include a mesh (see [0062], 12 and 13 are made of mesh, 10 is made of multiple self-expanding multi-filament segments).
Claim 5
Lorenzo discloses: The device according to claim 4, see 102 rejection above. Lorenzo further discloses: wherein mesh fiber tips the mesh ends of 12 at 14 and 13 at 18 (see Figs. 2-3) of said distal ends 14 and 18 respectively are blunted (see [0066], the ends of 14 and 18 are looped to be atraumatic, hence blunted).
Claim 6
Lorenzo discloses: The device according to claim 4, see 102 rejection above. Lorenzo further discloses: wherein free ends 14 includes the free ends of the mesh of 12 and 18 includes the free ends of the mesh of 13 (see Figs. 2-3) of said mesh the mesh of 12 + 13 are not bent towards each other (see Figs. 2-3, [0066], the ends are looped to be blunted, not folded back on themselves, looping can be shown by the encircling circumference) in the relaxed expanded configuration.
Claim 12
Lorenzo discloses: The device according to claim 1, see 102 rejection above. Lorenzo further discloses: wherein said expandable body 12 and said support 13 are formed by a single tubular structure 10 (see Figs. 2-3, [0062], 12 and 13 are made from a singular tubular braid, 10), folded to provide said expandable body 12 and said support 13.
Claim 13
Lorenzo discloses: The device according to claim 1, see 102 rejection above. Lorenzo further discloses: wherein said expandable body 12 in said expanded configuration (see Fig. 5B, [0075] and [0081], in the expanded configuration, 12 does not collapse within the aneurysm A through support from 13) is sufficiently resilient to resist collapse within an aneurysm A (see Fig. 5B, [0081]).
Claim 14
Lorenzo discloses: The device according to claim 1, see 102 rejection above. Lorenzo further discloses: wherein said support 13 extends beyond (see Figs. 2-3 and 5B, 13 extends beyond 14) said distal end 14 of said expandable body 12.
Claim 16
Lorenzo discloses: The device according to claim 1, see 102 rejection above. Lorenzo further discloses: wherein at least one portion a portion of 12 of said expandable body 12 is sufficiently flexible (see [0064], 12 can flexibly conform to a plurality of different shaped aneurysms) to conform, at least partially, to an internal shape of an aneurysm.
Claim 17
Lorenzo discloses: The device according to claim 1, see 102 rejection above. Lorenzo further discloses: wherein said expandable body 12 is elastically expandable (see [0064], 12 can flexibly conform to a plurality of different shaped aneurysms, see also [0067], 12 is formed from nitinol, which is known in the field of art to be an elastic material) to said expanded configuration.
Claim 21
Lorenzo discloses: The device according to claim 1, see 102 rejection above. Lorenzo further discloses: wherein the central protrusion (see annotated Fig. 9 below) protrudes from the base the base of 12 at 16 is dome shaped (see annotated Fig. 9 below, the central rounded protrusion is dome/hollowed dome shaped) with a curvature in continuity with an arch-shaped curvature the curve of the central protrusion continues into the curvature of the base of 12 at 16 (see Fig. 9) of the base the base of 12 at 16.
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A variant interpretation of Lorenzo for rejections of claims 1 and 15
Claim 1
Lorenzo discloses: An intravascular device 10 (see Figs. 1A-5B, [0078]) having a relaxed expanded configuration (see Figs. 2-3, [0068] and [0074]), comprising: an expandable body 13 (see Figs. 1A-5B, [0078]) having an expanded configuration (see Fig. 5B, [0080], expanded configuration) and a contracted configuration (see Fig. 1B, [0062], a collapsed configuration for delivery), said expandable body 13 in said expanded configuration (see Fig. 5B) having a convex curved shape (see Fig. 5B, 13 has a convex curved shape) having a base the base of 13 at the proximal end 16 of 10 (see Fig. 5B) and walls the walls of 13 that extend distally from the base of 13 (see Fig. 5B), said expandable body 13 comprises a proximal end 16 (see Fig. 5B, [0062]), and a distal end 18 (see Fig. 5B, [0062]), wherein said base the base of 13 is at 16 is disposed at said proximal end 16, and said walls the walls of 13 extend distally from the base of 13 which is at 16 (see Fig. 2-3 and 5B) extend distally from said base the base of 13 at 16; a support 12 (see Figs. 5A-5B, [0062]) which provides a double layer (see Figs. 5A-5B, 12 with 13 overlaps at portions over the neck of the aneurysm, providing a second or double layer) to at least a portion the support provides a double layer to both the walls and the base of 13 of said expandable body 13, wherein said walls the walls of 13 have a double layer with 12 (see Figs. 5A-5B) have said double layer, and a connector 44 (see Figs. 1A-5B, [0062]) disposed at said proximal end 16 of said expandable body 13 and connecting proximal ends the proximal ends of the walls of 13 are connected by 44 (see Fig. 5B) of said walls, wherein distal ends the distal ends of 13 at 18 are not connected (see Fig. 5B) of said walls are not connected, wherein in the relaxed expanded configuration (see Figs. 2-3) a cross section the cross-section of the walls of 13 formed by plane segments of the circumference of 13 (see Figs. 2-3, these cross-sections of the walls of 13 by taking plane segments of the circumference increases more from the proximal end 16 to the distal end 18, this interpreted is consistent with applicant’s explanation see [0321] of applicant’s PGPUB that it is the overall width of the expandable body that increases along its length rather than the thickness of the walls) of said walls increases along a length the length of the walls of 13 (see Figs. 2-3) of said walls.
Claim 15
Lorenzo discloses: The device according to claim 1, see 102 rejection above. Lorenzo further discloses: wherein said support 13 includes at least a portion the walls and base of 12 (see Fig. 5B) extending around (see Fig. 5B, the walls of 12, extend in a circumferential/radial manner to surround the walls and base of 13, which meets the definition of “around” as per the definition of the online Merriam-Webster dictionary of “so as to encircle or enclose”) one or both of said walls the walls of 12 and said base the base of 12 of said expandable body 12.
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lorenzo (non-variant interpretation) in view of O’Halloran et al (US 20210369283 A1), herein referenced to as “O’Halloran”.
Claim 7
Lorenzo discloses: The device according to claim 1, see non-variant interpretation 102 rejection above. Lorenzo does not explicitly disclose: further comprises an element configured to stimulate a closure of an aneurysm.
However, O’Halloran in a similar field of invention teaches an occlusive device (see Figs. 1A-1F) with an expandable body 7 (see Figs. 1A-1F), a support 6 (see Figs. 1A-1F), and a connector 8 (see Figs. 1A-1F). O’Halloran further teaches: further comprises an element 12 (see Figs. 1A-1F, [0120] and [0110], the treatment element is the modular active element, and this can comprise a radioactive material/source, which meets the 112f interpretation of a “radioactive source”) configured to stimulate a closure of an aneurysm.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lorenzo to incorporate the teachings of O’Halloran and teach an intravascular device with an element configured to stimulate a closure of an aneurysm. Motivation for such can be found in O’Halloran as this allows the device to perform radiation therapy and selective ablate tissue (see [0110]).
Claim(s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lorenzo (non-variant interpretation) in view of O’Halloran and Sharma (US 20210121183 A1), herein referenced to as “Sharma”.
Claim 8
Lorenzo discloses: A system (see Figs. 1-5B, 1 + 20 + 30) comprising: The device according to claim 1, see non-variant interpretation 102 rejection above. Lorenzo further discloses: further comprising a delivery apparatus 20 + 30 (see Figs. 1-5B, [0069]).
Lorenzo does not explicitly disclose: comprising a delivery apparatus and the holder comprises an electrically insulating holder, said electrically insulating holder is configured for preventing electrical stimulation by electrolytic and/or electrothermic detachment of said delivery apparatus from said expandable device.
However, O’Halloran in a similar field of invention teaches an occlusive device (see Figs. 1A-1F) with an expandable body 7 (see Figs. 1A-1F), a support 6 (see Figs. 1A-1F), and a connector 8 (see Figs. 1A-1F). O’Halloran further teaches: an insulating holder 5 (see Figs. 1A-1F, [0120]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lorenzo to incorporate the teachings of O’Halloran and teach an intravascular device with an insulating holder. Motivation for such can be found in O’Halloran as this allows engagement with an active element such as a radioactive material/source for radiation therapy (see [0110] and [0120])
The combination of Lorenzo and O’Halloran does not explicitly teach: the holder is an electrically insulating holder.
However, Sharma in a similar field of invention teaches an occlusive device 600 (see Fig. 6A) with an expandable body 607 (see Fig. 6A), a connector 616 (see Fig. 6A), and a holder 610 (see Fig. 6A, 610 holds 630, hence 610 is a holder). Sharma further teaches: the holder 610 is an electrically insulating holder (see [0103], 610 is formed of PEEK, which according to the applicant is an electrically insulating material, see [0513] of applicant’s PGPUB).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Lorenzo and O’Halloran to incorporate the teachings of Sharma and have an intravascular device’s holder made of an electrically insulating material such as PEEK. This is due to PEEK (see [0513]) for holders being common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
The language, " said electrically insulating holder is configured for preventing electrical stimulation by electrolytic and/or electrothermic detachment of said delivery apparatus from said expandable device," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Lorenzo, O’Halloran, and Sharma meets the structural limitations of the claim, and is capable of the holder when made of PEEK, and located surrounding the connector which a delivery apparatus is inserted into would prevent electrical stimulation as it is made of an electrically insulating material such as PEEK.
Claim 9
The combination of Lorenzo, O’Halloran, and Sharma teaches: The system of claim 8, see 103 rejection above. Sharma further teaches: wherein said electrically insulating holder 610 comprises an ionizing radiation resistant polymer PEEK (see [0103], 610 is formed of PEEK, which according to the applicant is an ionizing radiation resistant polymer, see [0513] of applicant’s PGPUB).
Claim 10
The combination of Lorenzo, O’Halloran, and Sharma teaches: The system of claim 9, see 103 rejection above. Sharma further teaches: wherein said ionizing radiation resistant polymer PEEK comprises PEEK (see [0103], PEEK).
Claim 11
The combination of Lorenzo, O’Halloran, and Sharma teaches: The system of claim 8, see 103 rejection above. Lorenzo further discloses: further comprising a bonding material adhesive (see Fig. 1A, [0073], the adhesive connects 10, which includes 12 and 13 to 44, and hence 12 to 13 as well) which attaches said expandable body 12 and said support 13, and/or which attaches said expandable body and said support to said holder (will not be examined here due to being an optional claim limitation).
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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771