DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Information Disclosure Statement
2. The Information Disclosure Statement submitted on 26 June 2024 has been considered by the Examiner.
Claim Rejections - 35 USC § 103
3. 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.
4. Claims 1-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (US 2017/0172721 A1) in view of Weaver et al. (US 2004/0158273 A1).
Regarding claim 1, Yang teaches a vascular implant (intravascular filter device 10 is deployed in the vena cava [abstract, 0009, 0028]), comprising:
an implant body (figure 1 illustrates the body of the intravascular filter device 10 [0028, FIG. 1]) that includes:
a hub or ring having a central opening (the hub 16 is a ring with an empty center 18 [0038, FIG. 1]), said hub or ring defining a plane (the Examiner respectfully submits that the structure of the hub 16 inherently defines a plane [FIGS. 1-3]), a hub central longitudinal axis (the Examiner respectfully submits that the structure of the hub 16 inherently defines a central longitudinal axis [FIGS. 1-3]), and an outer hub or ring periphery (figures 1-2 illustrates the hub 16 (e.g., ring) having an outer periphery [FIGS. 1-2]);
multiple appendages that each extend radially from said hub or ring (the plurality of appendages or struts 12 extend radially from the hub 16 [0007-0008, 0029]), each appendage having a proximal appendage section (the plurality of struts 12 comprise first segments 20 (e.g., proximal sections) [0029]) and a distal end appendage section (the plurality of struts 12 comprise second segments 24 (e.g., distal sections) [0029]);
wherein each said proximal appendage section forms an angle with said plane (the first segments 20 (e.g., proximal sections) disjoin and angle to form second segments 24 (e.g., distal sections) at the split 22 [0029, FIG. 1]. Specifically, the first segments 20 form the angle with respect to the plane of the hub 16 [FIG. 1]);
an engagement anchor on each said appendages (the struts 12 comprise petals 26 having a pad structure 34 [0030, 0032]. Specifically, the engagement anchors or barbs 36 are located downstream of the pad structure 34 [0032-0033, 0045, FIG. 1]);
each engagement anchor extending away from a said appendage (figure 1 and figure 3 illustrates the engagement anchors or barbs 36 extending away from the petals 26 of the struts 12 [FIG. 1, FIG. 3]); and
wherein said engagement anchors prevent rotation of said implant body in a selected rotational direction (the engagement anchors or barbs 36 are configured to engage the wall of the vessel in order to prevent movement or migration of the device [0033, 0045]. The Examiner respectfully submits that the intravascular device 10 cannot be rotated, as the barbs 36 prevent movement or migration of the device [0028, 0033, 0045]).
Yang does not explicitly teach wherein the angle of the proximal appendage section is an acute angle;
wherein each of the engagement anchors extends toward an adjacent anchor along a generally circular path.
The prior art by Weaver is analogous to Yang, as they both teach an intravascular filtering device ([abstract]).
Weaver teaches wherein the angle of the proximal appendage section is an acute angle (the appendages or filter legs 14 extend from the hub 12 [0019]. Specifically, the appendages or filter legs 14 are disposed at an acute angle (e.g., 60 degrees) such that the filter 10 symmetrically engages the vessel wall [0019, FIG. 1]);
wherein each of the engagement anchors (engagement anchors 20 (e.g., hooks or barbs) [0003, 0015, 0022]) extends toward an adjacent anchor along a generally circular path ([FIG. 2]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the angle of Yang’s proximal appendage section angle be an acute angle, as taught by Weaver. This angle is beneficial, as it will allow each of the appendages (e.g., struts or legs) to symmetrically engage the vessel wall (see paragraphs [0015, 0019] by Weaver). Furthermore, it would have been obvious to a person having ordinary skill in the art to modify each of Yang’s engagement anchors to extend toward an adjacent anchor along a circular path, as taught by Weaver. The advantage of such modification may improve the engagement between the device and the vessel wall (see paragraphs [0015, 0022] and [FIG. 2] by Weaver).
Regarding claim 2, Weaver teaches wherein each engagement anchor is a hook (the appendages or filter legs 14 comprise engagement anchors 20 (e.g., hooks) [0003, 0015, 0022]) that extends along a circular path toward the engagement anchor of an adjacent appendage ([FIG. 2]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the engagement anchor suggested by Yang in view of Weaver to comprise a hook, as further taught by Weaver. The advantage of such modification may may improve the engagement between the device and the vessel wall (see paragraphs [0015, 0022] and [FIG. 2] by Weaver).
Regarding claim 3, Yang teaches wherein each appendage has a bend that connects each proximal appendage section to a said distal appendage section (the first segments 20 (e.g., proximal sections) disjoin and angle (e.g., bend) to form second segments 24 (e.g., distal sections) at the split 22 [0029, FIG. 1]).
Regarding claim 4, Yang teaches wherein each appendage proximal section is a first straight section that connects to the hub or ring (figures 1-2 illustrates the first segments 20 (e.g., proximal sections) of the struts 12 having a straight section 37 that connects to the hub 16 [0028-0029, FIGS. 1-2]). Meanwhile, Weaver teaches wherein said distal appendage section is a second straight section that connects to a said engagement anchor (figure 1 illustrates the struts or filter legs 14 having straight distal sections 18 that connect to the engagement anchors 20 (e.g., hooks) [0015, FIG. 1]).
Regarding claim 5, Yang teaches wherein the selected rotational direction is clockwise or counterclockwise relative to said central longitudinal axis (Applicant states that the engagement anchors prevent rotation of the implant body in a selected rotational direction [claim 1]. As stated previously, Yang’s engagement anchors or barbs 36 are configured to engage the wall of the vessel in order to prevent movement or migration of the device [0033, 0045]. In this case, the barbs 36 will prevent the intravascular device 10 from moving or rotating in a clockwise or counter clockwise direction [0028, 0033, 0045]).
Regarding claim 6, Yang teaches wherein each of said anchors is a pointed projection (figure 1 illustrates the anchors or barbs 36 having a sharp pointed tip that engages the wall of a vessel [0032, FIG. 1]).
Regarding claim 7, Yang teaches wherein each said anchor includes a sharp pointed portion (figure 1 illustrates the anchors or barbs 36 having a sharp pointed tip that engages the wall of a vessel ([0032, FIG. 1]).
Regarding claim 8, Weaver teaches wherein each said anchor includes a hook (the engagement anchors 20 are hooks [0003, 0015, 0022, FIG. 1]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the engagement anchor suggested by Yang in view of Weaver to comprise a hook, as further taught by Weaver. The advantage of such modification may may improve the engagement between the device and the vessel wall (see paragraphs [0015, 0022] and [FIG. 2] by Weaver).
Regarding claim 9, Yang teaches wherein said hub or ring occupies a plane (the Examiner respectfully submits that the structure of the hub 16 inherently defines a plane [FIGS. 1-3]). Furthermore, Yang and Weaver suggest at least one section of each appendage forms an acute angle with said plane (Yang teaches the struts 12 comprising first segments 20 (e.g., proximal sections) that disjoin and angle to form second segments 24 (e.g., distal sections) at the split 22 [0029, FIG. 1]. Specifically, the first segments 20 form the angle with respect to the plane of the hub 16 [FIG. 1]. Meanwhile, Weaver teaches each of the filter legs 14 (e.g., struts) extending from the hub 12 at an acute angle (e.g., 60 degrees) such that the filter 10 symmetrically engages the vessel wall [0019, FIG. 1]).
Regarding claim 10, Yang teaches a vascular implant (intravascular filter device 10 is deployed in the vena cava [abstract, 0009, 0028]), comprising:
a) an implant body that includes a hub or ring having a central opening (the hub 16 is a ring with an empty center 18 [0038, FIG. 1]), a central longitudinal axis (the Examiner respectfully submits that the structure of the hub 16 inherently defines a central longitudinal axis [FIGS. 1-3]) and an outer ring periphery (figures 1-2 illustrates the hub 16 (e.g., ring) having an outer periphery [FIGS. 1-2]);
b) said implant body including multiple appendages that each connect with said hub or ring at said outer periphery (the plurality of appendages or struts 12 extend radially from the outer periphery of the hub 16 [0007-0008, 0029]); and
c) engagement anchors on said implant body that resist torsion, wherein the anchors resist rotation of the implant body in a selected rotational direction (the engagement anchors or barbs 36 are configured to engage the wall of the vessel in order to prevent movement or migration of the device [0033, 0045]. The Examiner respectfully submits that the intravascular device 10 cannot be rotated, as the barbs 36 prevent movement or migration of the device [0028, 0033, 0045]).
Yang does not explicitly teach wherein each said anchor extending along a circular path toward another said engagement anchor so that all of the anchors resist rotation of the implant body in the selected rotational direction.
The prior art by Weaver is analogous to Yang, as they both teach an intravascular filtering device ([abstract]).
Weaver teaches wherein each said anchor extends along a circular path toward another said engagement anchor (figure 2 illustrates the engagement anchors 20 (e.g., hooks) extending along a circular path [0003, 0015, 0022, FIG. 2]) so that all of the anchors resist rotation of the implant body in the selected rotational direction (the pointed tip portion 28 of the engagement anchors 20 (e.g., hooks) is configured to engage the vessel wall which prevents the device from moving or rotating [0015, 0022]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify each of Yang’s engagement anchors to extend toward an adjacent anchor along a circular path, as taught by Weaver. The advantage of such modification may improve the engagement between the device and the vessel wall (see paragraphs [0015, 0022] and [FIG. 2] by Weaver).
Regarding claim 11, Weaver teaches wherein each engagement anchor is a hook (the appendages or filter legs 14 comprise engagement anchors 20 (e.g., hook or barb) [0003, 0015, 0022]) that extends along a circular path toward the engagement anchor of an adjacent appendage ([FIG. 2]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the engagement anchor suggested by Yang in view of Weaver to comprise a hook, as further taught by Weaver. The advantage of such modification may may improve the engagement between the device and the vessel wall (see paragraphs [0015, 0022] and [FIG. 2] by Weaver).
Regarding claim 12, Weaver teaches wherein each appendage has a bend portion (a slight outward bend can be imparted to a portion of each filter leg 14 [0016, FIG. 1]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the appendages suggested by Yang in view of Weaver to comprise a bend portion, as further taught by Weaver. The advantage of such modification may may improve the engagement between the device and the vessel wall (see paragraphs [0015-0016, 0022] and [FIG. 2] by Weaver).
Regarding claim 13, Yang teaches wherein each appendage has a first straight section that connects to the hub or ring (figures 1-2 illustrates the first segments 20 (e.g., proximal sections) of the struts 12 having a straight section 37 that connects to the hub 16 [0028-0029, FIGS. 1-2]). Meanwhile, Weaver teaches a second straight section that connects to a said engagement anchor (figure 1 illustrates the struts or filter legs 14 having straight distal sections 18 that connect to the engagement anchors 20 (e.g., hooks) [0015, FIG. 1]).
Regarding claim 15, Yang teaches wherein each said anchor includes a sharp pointed portion (figure 1 illustrates the anchors or barbs 36 having a sharp pointed tip that engages the wall of a vessel ([0032, FIG. 1]).
Regarding claim 16, Weaver teaches wherein each said anchor includes a hook (the engagement anchors 20 are hooks [0003, 0015, 0022, FIG. 1]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the engagement anchor suggested by Yang in view of Weaver to comprise a hook, as further taught by Weaver. The advantage of such modification may may improve the engagement between the device and the vessel wall (see paragraphs [0015, 0022] and [FIG. 2] by Weaver).
Regarding claim 17, Yang teaches wherein said hub or ring occupies a plane (the Examiner respectfully submits that the structure of the hub 16 inherently defines a plane [FIGS. 1-3]). Furthermore, Yang and Weaver suggest wherein each appendage has a section that forms an acute angle with said plane (Yang teaches the struts 12 comprising first segments 20 (e.g., proximal sections) that disjoin and angle to form second segments 24 (e.g., distal sections) at the split 22 [0029, FIG. 1]. Specifically, the first segments 20 form the angle with respect to the plane of the hub 16 [FIG. 1]. Meanwhile, Weaver teaches each of the filter legs 14 (e.g., struts) extending from the hub 12 at an acute angle (e.g., 60 degrees) such that the filter 10 symmetrically engages the vessel wall [0019, FIG. 1]).
Regarding claim 18, Yang teaches a vascular implant (intravascular filter device 10 is deployed in the vena cava [abstract, 0009, 0028]), comprising:
an implant body (figure 1 illustrates the body of the intravascular filter device 10 [0028, FIG. 1]) that includes a hub or ring having a central opening (the hub 16 is a ring with an empty center 18 [0038, FIG. 1]), a central longitudinal axis (the Examiner respectfully submits that the structure of the hub 16 inherently defines a central longitudinal axis [FIGS. 1-3]), and an outer hub or ring periphery (figures 1-2 illustrates the hub 16 (e.g., ring) having an outer periphery [FIGS. 1-2]);
said implant body including multiple appendages that each connect with said hub or ring (the plurality of appendages or struts 12 extend radially from the hub 16 [0007-0008, 0029]), each appendage having a distal end portion (the plurality of struts 12 comprise second segments 24 (e.g., distal sections) [0029]);
engagement anchors on each said appendage distal end portion that each have a pointed or sharp tip (the struts 12 comprise petals 26 having a pad structure 34 [0030, 0032]. Specifically, the engagement anchors or barbs 36 are located downstream of the pad structure 34 [0032-0033, 0045, FIG. 1]. Furthermore, the anchors or barbs 36 having a sharp pointed tip that engages the wall of a vessel [0032, FIG. 1]);
wherein the engagement anchors are positioned to engage a patient's vascular tissue so that rotation of the implant body is resisted in a selected rotational direction (the engagement anchors or barbs 36 are configured to engage the wall of the vessel in order to prevent movement or migration of the device [0033, 0045]. The Examiner respectfully submits that the intravascular device 10 cannot be rotated, as the barbs 36 prevent movement or migration of the device [0028, 0033, 0045]).
Yang does not explicitly teach wherein the sharp tip on the engagement anchors extends toward another adjacent engagement anchor.
The prior art by Weaver is analogous to Yang, as they both teach an intravascular filtering device ([abstract]).
Weaver wherein the sharp tip on the engagement anchors (engagement anchors 20 (e.g., hook or barb) [0003, 0015, 0022]) extends toward another adjacent anchor ([FIG. 2]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify each of Yang’s engagement anchors to extend toward an adjacent anchor, as taught by Weaver. The advantage of such modification may improve the engagement between the device and the vessel wall (see paragraphs [0015, 0022] and [FIG. 2] by Weaver).
Regarding claim 19, Weaver teaches wherein each engagement anchor forms a hook (the engagement anchors 20 are hooks [0003, 0015, 0022, FIGS. 1-2]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the engagement anchor suggested by Yang in view of Weaver to comprise a hook, as further taught by Weaver. The advantage of such modification may may improve the engagement between the device and the vessel wall (see paragraphs [0015, 0022] and [FIG. 2] by Weaver).
Regarding claim 20, Weaver teaches wherein each engagement anchor has a curvature (figures 1-2 illustrates the engagement anchors 20 (e.g., hooks) having a curvature [FIGS. 1-2]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the engagement anchor suggested by Yang in view of Weaver to comprise a curvature, as further taught by Weaver. The advantage of such modification may may improve the engagement between the device and the vessel wall (see paragraphs [0015, 0022] and [FIG. 2] by Weaver).
5. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Weaver et al., further in view of Wolfrum et al. (WO 2022/132727 A1, with citations to the corresponding US Publication No. 2024/0058142 A1).
Regarding claim 22, Yang in view of Weaver suggests the vascular implant of claim 1. Yang and Weaver do not explicitly teach wherein the implant body and appendages are 3D printed of a material that cannot be machined.
The prior art by Wolfrum is analogous to Yang, as they both teach vena cava filters ([0050]).
Wolfrum teaches the implant body and appendages are 3D printed of a material that cannot be machined (Wolfrum teaches a vena cava filter that may be 3D printed using a photo-curable polymer [abstract, 0028, 0050]. The Examiner respectfully submits that Wolfrum’s 3D printing techniques may be used to 3D print Yang’s vena cava filter which consist of the implant body and the appendages [see claim 1 above]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Yang’s implant body and appendages to be 3D printed of a material that cannot be machined, as taught by Wolfrum. The advantage of such modification will allow for 3D printing the device with a photo-curable material which may improve the flexibility of the device (see paragraphs [0028, 0030, 0050] by Wolfrum).
Statement on Communication via Internet
6. Communications via Internet email are at the discretion of the applicant. All Internet communications between USPTO employees and applicants must be made using USPTO tools.
Without a written authorization by applicant in place, the USPTO will not respond via Internet email to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. A paper copy of such correspondence and response will be placed in the appropriate patent application. Except for correspondence that only sets up an interview time, all correspondence between the Office and the applicant including applicant's representative must be placed in the appropriate patent application. If an email contains any information beyond scheduling an interview such as an interview agenda or authorization, it must be placed in the application.
For those applications where applicant wishes to communicate with the examiner via Internet communications, e.g., email or video conferencing tools, the following is a sample authorization form which may be used by applicant:
"Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file."
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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, Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792