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
As of the Preliminary Amendment filed 10/28/2024, claims 1-20 are pending while previously filed claims 21-23 are cancelled. No claims have been amended.
Claim Objections
Claims 4, 9, 10, 13, and 20 are objected to because of the following informalities:
Claim 4, line 2: “height that is less that about ¼ of a total height” contains a spelling error and should be amended to recite “height that is less than about ¼ of a total height” instead.
Claim 9, lines 1-2: “the expanded shape of the second layer is substantially barrel shape” is grammatically incorrect and should be amended to recite either “the expanded shape of the second layer is substantially barrel-shaped” or “the expanded shape of the second layer is substantially a barrel shape” instead.
Claim 10, line 3: “wherein the proximal portion of having the substantially frustoconical shape” is grammatically incorrect and should be amended to remove the erroneous “of” such that the claim reads “wherein the proximal portion having the substantially frustoconical shape” instead.
Claim 13, line 2: “permeable mesh” should instead recite “permeable shell” to match the antecedent basis established in claim 1.
Claim 20, line 2: the limitation “the device” does not have basis in claim 19, which instead recites “an implant”. It is recommended that claim 20 be amended to recite “wherein the proximal band is the only band in the implant” instead.
Appropriate correction is required.
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 1-13 and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pulugurtha et al. (US PGPub 2021/0128165 A1).
With respect to claim 1, Pulugurtha et al. discloses a device for treatment of a patient’s cerebral aneurysm (10 in Fig. 1A, PP [0156]: “the second elongate shaft 108 is generally constructed to track over a conventional guidewire in the cervical anatomy and into the cerebral vessels associated with the brain”), comprising:
a permeable shell (102 in Fig. 1A, see also Figs. 1C-D) comprising a first layer (124), a second layer (122), a proximal end (end near 134), a distal end (end near 132), and a transitional section (128) connecting the first (124) and second layer (122), wherein the permeable shell (102) has a radially constrained elongated state configured for delivery within a catheter lumen and an expanded state with a longitudinally shortened configuration relative to the radially constrained state (PP [0161]: “the occlusive member 102 may comprise an expandable element having a low-profile or constrained state while positioned within a catheter (such as the second elongated shaft 108) for delivery to the aneurysm and an expanded state in which the expandable element is configured to be positioned within an aneurysm (such as a cerebral aneurysm)”, see expanded state in Figs. 1C-D),
wherein the first and second layers (124 and 122, respectively) are formed from a plurality of elongate filaments that are woven together to form a mesh (PP [0162]: “the occlusive member 102 may comprise a mesh 101 formed of a plurality of braided filaments that have been heat-set to assume a predetermined shape enclosing an interior volume 130 when the mesh 101 is in an expanded, unconstrained state”), wherein each of the plurality of elongate filaments have a first end and a second end, wherein the first and second ends of each of the plurality of elongate filaments are gathered at the proximal end of the permeable shell (see Figs. 1C-D where 122 and 124 loop at 126 and each end is gathered at the end near 134) in a proximal band (114, PP [0168]: “each of the plurality of filaments have a first end positioned at the proximal portion of the mesh 101 and a second end also positioned at the proximal portion of the mesh 101”), and
wherein the transitional section (128) of the permeable shell (102) comprises a first end portion (body of 124 proximal to the uppermost distal end of 124) connected to a distal end of the first layer (124) and a second end portion (body of 122 at the uppermost distal end of 122) connected to a distal end of the second layer (122), wherein the second end portion is inverted (the body of 122 at the uppermost distal end of 122 inverts past 128 to become the first layer 124 PP [0162]: “the mesh 101 may have inner and outer layers 122, 124 that have proximal ends fixed relative to one another at the second coupler 114 and meet distally at a distal fold 128 surrounding an aperture 126”), and wherein the transitional portion (128) of the plurality of filaments is not surrounded by a band (see Figs. 1C-D, 128 does not include a band).
Regarding claim 2, Pulugurtha et al. further discloses wherein the proximal band (114 in Figs. 1C-D) is the only band in the device (coupler 114 is the only band).
Regarding claim 3, Pulugurtha et al. further discloses wherein the second layer (122 in Figs. 1C-D) is an inner layer of the device and the first layer (124) is an outer layer of the device (PP [0162]: “inner and outer layers 122, 124”).
Regarding claim 4, Pulugurtha et al. further discloses wherein the transitional section (128 in Figs. 1C-D) comprises a height that is less [than] about ¼ of a total height of the permeable shell (102, see Fig. 1C, the height of 128 is far less than ¼ of the total height of 102).
Regarding claim 5, Pulugurtha et al. further discloses wherein in an unconstrained configuration, an expanded shape of the first layer (124 in Figs. 1C-D) is different than an expanded shape of the second layer (122, see Fig. 1D, PP [0166]: “In any case, the inner layer 124 may have a shape that substantially conforms to the shape of the outer layer 124, or the inner and outer layers 122, 124 may have different shapes. For example, as shown in FIG. 1D, the inner layer 122 may have a diameter or cross-sectional dimension that is less than the outer layer 124”).
Regarding claim 6, Pulugurtha et al. further discloses wherein in an unconstrained configuration an outer surface of a distal region of an expanded shape of the first layer (outer upper surface of 124 in Figs. 1C-D, see annotated Fig. 1D below) has a substantially frustoconical shape (see annotation below, the shape of the outer distal region of layer 124 is frustoconical because it has a tapered shape towards the distal end, with a wider “base” area towards the middle of the device and a narrower distal end).
PNG
media_image1.png
319
510
media_image1.png
Greyscale
Regarding claim 7, Pulugurtha et al. further discloses wherein in an unconstrained configuration, the second layer (122 in Figs. 1D) comprises an expanded shape comprising a top surface that defines a plane that is substantially perpendicular to a vertical axis of the permeable shell (102, see annotated Fig. 1D below, the plane is substantially perpendicular to a vertical axis of the shell).
PNG
media_image2.png
368
610
media_image2.png
Greyscale
Regarding claim 8, Pulugurtha et al. further discloses wherein in an unconstrained configuration, an inner surface of a distal portion of the expanded shape of the first layer (inner upper surface of 124 in Fig. 1D) does not contact at least about 50% of a first area defined by the plane of the top surface (see plane of top surface in annotated Fig. 1D above, the inner surface of 124 above this plane does not contact the plane and specifically does not contact at least 50% of a first area defined by the plane of the top surface).
Regarding claim 9, Pulugurtha et al. further discloses wherein in an unconstrained configuration, the expanded shape of the second layer (122 in Fig. 1D) is substantially barrel shape (PP [0074] of the present disclosure describes a barrel-like shape to be “globular” or spherical, Pulugurtha et al. states in PP [0162] that “Example shapes include a globular shape, such as a sphere”, Fig. 1D shows a cross-section of inner layer 122, inner layer 122 is globular or spherical in a three-dimensional view due to its rounded shape, see also Fig. 1B).
Regarding claim 10, Pulugurtha et al. further discloses wherein in an unconstrained configuration, the second layer (122 in Fig. 1D) comprises an expanded shape comprising a proximal portion having a substantially frustoconical shape (proximal end of 122 in Fig. 1D, see annotation below, the shape is frustoconical because it has a tapered shape where the distal end is wider than the proximal end), wherein the proximal portion of having the substantially frustoconical shape (see annotation below) defines a second area (area of 130 bounded by the dotted lines defining the frustoconical shape in the annotation below).
PNG
media_image3.png
319
510
media_image3.png
Greyscale
Regarding claim 11, Pulugurtha et al. further discloses wherein an inner surface of a proximal portion of the expanded shape of the first layer (inner surface of proximal end of 124 in Fig. 1D) does not contact at least 50% of the second area (area of 130 bounded by the dotted lines defining the frustoconical shape in the annotation above, the inner surface of 124 only contacts the second area where it meets 122 at the band 124, PP [0162]: “the inner and outer layers 122, 124 are depicted spaced apart from one another along their lengths”).
Regarding claim 12, Pulugurtha et al. further discloses wherein the mesh (101 in Fig. 1D) is a tubular mesh having an inner surface and an outer surface (PP [0162]: “the mesh 101 may have inner and outer layers 122, 124 that have proximal ends fixed relative to one another at the second coupler 114 and meet distally at a distal fold 128 surrounding an aperture 126”, PP [0164]: “the outer and/or inner layers 122 and 124 extend distally and radially outwardly from the second coupler 114, then extend distally and radially inwardly up to a distal terminus of the occlusive member 102 (e.g., the fold 128)”, the mesh is an inverted tubular mesh connected to band 114 at both ends), wherein an outer surface of the first layer (124) is the inner surface of the tubular mesh (the interior portion of 122 defining 130 extends and inverts into the outer surface of 124, the outer surface of first layer 124 extends to meet and become the inner surface of the tubular mesh).
Regarding claim 13, Pulugurtha et al. further discloses wherein in an unconstrained configuration, the permeable [shell] (102 in Fig. 1D) further comprises a distal void space (distal space between 124 and 122 around 128, see annotation below) in a distal region of the permeable shell (102) and a proximal void space (130) in the proximal region of the permeable shell (102).
PNG
media_image4.png
319
510
media_image4.png
Greyscale
Regarding claim 15, Pulugurtha et al. further discloses wherein the distal void space (distal space between 124 and 122 around 128 in Fig. 1D, see annotation below, noting that the distal void and highlighted portions are mirrored onto the left side of 128 as well but are left out of the annotation for legibility purposes) is defined by a top surface of the expanded state of the second layer (122, the top surface of the upper portion of 122 forms a proximal base of the distal void space), an outer surface of the elongate section (128, the distal void is defined by an outer-facing surface of 128), and an inner surface of a distal region of the first layer (124, the distal void is defined by an inner surface of the distal portion of 124).
PNG
media_image5.png
436
677
media_image5.png
Greyscale
Regarding claim 16, Pulugurtha et al. further discloses wherein the proximal void space (130 in Fig. 1D) is defined by a bottom surface of an expanded state of the second layer (the bottom proximal end of 122 defines 130) and an inner surface of a proximal region of the first layer (the inner surface of the bottom proximal end of 124 also defines proximal void space 130 by having a diameter larger than 122 enabling the formation of proximal void space 130).
Regarding claim 17, Pulugurtha et al. further discloses wherein in an unconstrained configuration, the first layer (124 in Figs. 1C-D) does not have a corrugated or undulating portion (PP’s [0069-0070] of the present disclosure define this as having a “smooth curved surface”, 124 has a smooth rounded surface in Figs. 1C-D and lacks a corrugated or undulating portion).
Regarding claim 18, Pulugurtha et al. further discloses wherein in an unconstrained configuration the second layer (122 in Fig. 1C) does not have a corrugated or undulating portion (PP’s [0069-0070] of the present disclosure define this as having a “smooth curved surface”, 122 has a smooth rounded surface in Fig. 1C and lacks a corrugated or undulating portion).
With respect to claim 19, Pulugurtha et al. discloses a method for treating a cerebral aneurysm (PP [0150]: “Methods for treating intracranial aneurysms in accordance with at least some embodiments of the present technology include positioning an expandable occlusive member within the aneurysm”, PP [0156]: “the second elongate shaft 108 is generally constructed to track over a conventional guidewire in the cervical anatomy and into the cerebral vessels associated with the brain”) having an interior cavity and a neck (see aneurysm A in Fig. 3A comprising an interior cavity and a neck, PP [0185]: “A distal portion of the second elongated shaft 108 may be advanced through a neck N of the aneurysm A to locate a distal opening of the second elongated shaft 108 within an interior cavity of the aneurysm A”), comprising the steps of:
advancing an implant (102 in Fig. 1A) in a microcatheter to a region of interest in a cerebral artery (PP [0185]: “a physician may intravascularly advance the second elongated shaft 108 towards an intracranial aneurysm”), wherein the implant (102) comprises:
a permeable shell (body of 102 in Fig. 1A, see also Figs. 1C-D) comprising a first layer (124), a second layer (122), a proximal end (end near 134), a distal end (end near 132), and a transitional section (128) connecting the first (124) and second layer (122), wherein the permeable shell (102) has a radially constrained elongated state configured for delivery within a catheter lumen and an expanded state with a longitudinally shortened configuration relative to the radially constrained state (PP [0161]: “the occlusive member 102 may comprise an expandable element having a low-profile or constrained state while positioned within a catheter (such as the second elongated shaft 108) for delivery to the aneurysm and an expanded state in which the expandable element is configured to be positioned within an aneurysm (such as a cerebral aneurysm)”, see expanded state in Figs. 1C-D),
wherein the first and second layers (124 and 122, respectively) are formed from a plurality of elongate filaments that are woven together to form a mesh (PP [0162]: “the occlusive member 102 may comprise a mesh 101 formed of a plurality of braided filaments that have been heat-set to assume a predetermined shape enclosing an interior volume 130 when the mesh 101 is in an expanded, unconstrained state”), wherein each of the plurality of elongate filaments have a first end and a second end, wherein the first and second ends of each of the plurality of elongate filaments are gathered at the proximal end of the permeable shell (see Figs. 1C-D where 122 and 124 loop at 126 and each end is gathered at the end near 134) in a proximal band (114, PP [0168]: “each of the plurality of filaments have a first end positioned at the proximal portion of the mesh 101 and a second end also positioned at the proximal portion of the mesh 101”), and
wherein the transitional section (128) of the permeable shell (102) comprises a first end portion (body of 124 proximal to the uppermost distal end of 124) connected to a distal end of the first layer (124) and a second end portion (body of 122 at the uppermost distal end of 122) connected to a distal end of the second layer (122), wherein the second end portion is inverted (the body of 122 at the uppermost distal end of 122 inverts past 128 to become the first layer 124 PP [0162]: “the mesh 101 may have inner and outer layers 122, 124 that have proximal ends fixed relative to one another at the second coupler 114 and meet distally at a distal fold 128 surrounding an aperture 126”), and wherein the transitional portion (128) of the plurality of filaments is not surrounded by a band (see Figs. 1C-D, 128 does not include a band);
deploying the implant (102) within the cerebral aneurysm, wherein the permeable shell (body of 102) expands to the expanded state in the interior cavity of the aneurysm (PP [0185]: “A distal portion of the second elongated shaft 108 may be advanced through a neck N of the aneurysm A to locate a distal opening of the second elongated shaft 108 within an interior cavity of the aneurysm A. The elongated member 106 may be advanced distally relative to the second elongated shaft 108 to push the occlusive member 102 through the opening at the distal end of the second elongated shaft 108, thereby releasing the occlusive member 102 from the shaft 108 and allowing the occlusive member 102 to self-expand into a first expanded state”); and
withdrawing the microcatheter (108) from the region of interest after deploying the implant (102, PP [0185]: “Releasing the occlusive member 102 from the shaft 108 and allowing the occlusive member 102 to self-expand into a first expanded state may alternatively, or additionally, include withdrawing shaft 108 relative to the elongated member 106”, PP [0195]: “the first coupler 112 may be detached from the second coupler 114 and the elongated member 106 and second elongated shaft 108 may be withdrawn, thereby leaving the occlusive member 102 and embolic element 230 implanted within the aneurysm A”).
Regarding claim 20, Pulugurtha et al. further discloses wherein the proximal band (114 in Figs. 1C-D) is the only band in the device (coupler 114 is the only band).
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Pulugurtha et al. (US PGPub 2021/0128165 A1).
Regarding claim 14, Pulugurtha et al. fails to disclose wherein the distal void space is larger than the proximal void space.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Pulugurtha et al. device such that the distal void space is larger than the proximal void space because Pulugurtha et al. recognizes that relative void space, and more particularly relative diameters of the inner and outer layers, is a result effective variable which influences the resistance experienced by added embolic elements (PP [0166]: “the inner layer 122 may have a diameter or cross-sectional dimension that is less than the outer layer 124. Such a configuration may be beneficial in that the embolic element 230 experiences less resistance, at least initially, when pushing the distal wall of the occlusion member 102 downwardly towards the neck (as described in greater detail below)”) upon insertion of the device into an aneurysm when seeking to contain said embolic elements. The device of Pulugurtha et al. would not operate differently with a larger distal void space since a larger distal void space correlates with a smaller inner layer diameter, which predictably would yield less resistance when the device presses against embolic elements but would not otherwise change the main operating principle of the device. Furthermore, modifying the device of Pulugurtha et al. would have been obvious to try, and one of ordinary skill in the art could have pursued the finite number of solutions to the issue of relative inner/outer layer dimensions (resulting in the distal void space being larger, the proximal void space being larger, or the void spaces being the same size) with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771