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 Objections
3. Claim 12 is objected to because of the following informality:
Claim 12 does not include a period at the last line of the limitation.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
4. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
5. Claims 1-2, 4-6, 9, 11-13, 16, and 18-20 are rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by O’Connell (US 2003/0176888 A1).
Regarding claim 1, O’ Connel teaches a vascular implant (the filter device 100 is configured to be implanted within a blood vessel [0003, 0085, FIG. 12]), comprising:
a) a tubular body of a polymeric material, having opposed filter body ends and a central longitudinal axis (the filter device 100 comprises a tubular or annular retainer 106 having filter legs (e.g., round tubular or flattened wires) [0085-0088, FIG. 12, FIGS. 14-15]. Specifically, figure 12 illustrates filter legs (e.g., round tubular wires) including filter orientation members 110 which have opposed filter body ends (e.g., upper end and lower end) [0085-0086, 0089, FIG. 12]. Furthermore, the annular retainer 106 of the filter device 100 is composed of a polylactic acid material or polyglycolic acid suture material [0086-0088, FIG. 12, FIG. 15]. Lastly, figure 12 illustrates the filter device 100 having a central longitudinal axis “a” [0086, 0089, FIG. 12]);
b) said body having a generally tubular segmented side wall that includes multiple spaced apart wall panels surrounding a central open ended bore (the filter device 100 comprises an annular retainer 106 having a bore or opening that is configured to receive superior ends 104 of the filter legs 102 (e.g., round tubular wires or flattened wires) [0085-0086, FIG. 12, FIGS. 14-15]. Furthermore, figure 12 illustrates each of the filter legs 102 including wall panels or filter orientation members 110 which surround the annular retainer 106 [0085-0086, 0089, FIG. 12]. Lastly, the wall panels or filter orientation members 110 are configured to ensure centering of the filter device 100 in the vessel and to securely engage the filter device 100 with the interior wall of the blood vessel 28 [0089, FIG. 12]), each panel having a panel upper edge and a panel lower edge (figure 12 illustrates the wall panels or filter orientation members 110 having an upper edge surface and a lower edge surface [FIG. 12]);
c) said body including one or more filtering elements in said bore and in between filter body ends (the annular retainer 106 includes a bore or opening that is configured to receive the superior ends 104 of the filter legs 102 [0086, FIG. 12, FIGS. 14-15]. Furthermore, figure 12 illustrates the filter legs 102 being connected between filter body ends (e.g., upper and lower ends) of the filter orientation members 110 [FIG. 12]);
d) said one or more filtering elements including a hub at said central longitudinal axis (figures 12 and 17-18 illustrates the filter device 100 comprising an annular hub or spring 114 that is disposed along the central longitudinal axis “a” of the filter device 100 [0090, FIG. 12, FIGS. 17-18]) and multiple radially extending filtering arms that extend radially between said hub and said wall (figures 17-18 illustrates the filtering device 100 filtering arms or legs 102 that extends radially between the spring 114 (e.g., annular hub) and the filter orientation members 110 (e.g., wall panels) [0090, FIGS. 17-18]), wherein each arm connects to said hub and a said wall panel (figures 12 and 17-18 illustrates the filter arm or legs 102 being connected to the spring 114 (e.g., annular hub) and the filter orientation members 110 (e.g., wall panels) [0090, FIGS. 17-18]);
e) said tubular body having anchors that prevent migration and/or tilting (the annular retainer 106 comprises filter legs 102 (e.g., round tubular wires) having respective hooks or barbs 32 which engages the wall of the vessel and prevents the filter device 100 from migrating [0025, 0085, 0087]. Furthermore, the filter orientation members 110 may also include hooks or barbs 32 to prevent the filter device 100 from migrating [0089]); and
f) wherein each filtering element connects to a said panel in between panel upper and lower edges (figure 12 illustrates the filtering legs 102 being connected between the upper and lower edges of the filter orientation members 110 [FIG. 12]).
Regarding claim 2, O’Connell teaches wherein the body is of a resorbable material (the tubular body or annular retainer 106 is composed of a polylactic acid material or polyglycolic acid suture material [0087-0088, FIG. 12, FIG. 15]. The Examiner respectfully submits that polylactic acid material and polyglycolic acid suture material are known bioresorbable polymers [0088]).
Regarding claim 4, O’Connell teaches wherein said opposed ends include an upper end and a lower end (the filter device 100 comprises a tubular or annular retainer 106 having filter legs (e.g., round tubular or flattened wires) [0085-0088, FIG. 12, FIGS. 14-15]. Specifically, figure 12 illustrates filter legs (e.g., round tubular wires) including filter orientation members 110 which have opposed filter body ends (e.g., upper end and lower end) [0085-0086, 0089, FIG. 12]).
Regarding claim 5, O’Connell teaches wherein one or more of said arms extend from said hub toward one of said ends (figures 12 and 17-18 illustrates the filter legs or arms 102 extending radially from the spring 114 (e.g., annular hub) towards the filter orientation members 110 (e.g., wall panels) [FIG. 12, FIGS. 17-18]. Furthermore, figure 12 illustrates a distal portion of the filter legs or arms 102 being positioned adjacent to the upper end of the filter orientation members 110 [FIG. 12]).
Regarding claim 6, O’Connell teaches wherein one or more of said arms extend from said hub upwardly toward said upper end (figures 12 and 17-18 illustrates the filter legs or arms 102 extending radially from the spring 114 (e.g., annular hub) towards the filter orientation members 110 (e.g., wall panels) [FIG. 12, FIGS. 17-18]. Furthermore, figure 12 illustrates a distal portion of the filter legs or arms 102 being positioned adjacent to the upper end of the filter orientation members 110 [FIG. 12]).
Regarding claim 9, O’Connell teaches wherein the body and the one or more filtering elements define a vena cava filter (the retainer 106 may be removed to convert the filter device 100 into an open stent-like configuration [0086, 0124]. Specifically, the open stent-like configuration may be used as a vena cava filter [0086, 0124])
Regarding claim 11, O’Connell teaches wherein the body and one or more filtering elements define a convertible stent ([abstract]).
Regarding claim 12, O’Connell teaches a vascular implant (the filter device 100 is configured to be implanted within a blood vessel [0003, 0085, FIG. 12]), comprising:
a) a tubular body of a polymeric material, having opposed filter body ends and a central longitudinal axis (the filter device 100 comprises a tubular or annular retainer 106 having filter legs (e.g., round tubular or flattened wires) [0085-0088, FIG. 12, FIGS. 14-15]. Specifically, figure 12 illustrates filter legs (e.g., round tubular wires) including filter orientation members 110 which have opposed filter body ends (e.g., upper end and lower end) [0085-0086, 0089, FIG. 12]. Furthermore, the annular retainer 106 of the filter device 100 is composed of a polylactic acid material or polyglycolic acid suture material [0086-0088, FIG. 12, FIG. 15]. Lastly, figure 12 illustrates the filter device 100 having a central longitudinal axis “a” [0086, 0089, FIG. 12]);
b) said body having segmented side wall that includes multiple circumferentially spaced apart wall panels and a central bore (the filter device 100 comprises an annular retainer 106 having a bore or opening that is configured to receive superior ends 104 of the filter legs 102 (e.g., round tubular wires or flattened wires) [0085-0086, FIG. 12, FIGS. 14-15]. Furthermore, figures 12 and 18 illustrates each of the filter legs 102 including wall panels or filter orientation members 110 which are spaced apart and circumferentially surround the annular retainer 106 [0085-0086, 0089, FIG. 12, FIG. FIG. 18]. Lastly, the wall panels or filter orientation members 110 are configured to ensure centering of the filter device 100 in the vessel and to securely engage the filter device 100 with the interior wall of the blood vessel 28 [0089, FIG. 12]), each panel having upper and lower edges (figure 12 illustrates the wall panels or filter orientation members 110 having an upper edge surface and a lower edge surface [FIG. 12]);
c) said body including one or more filtering elements in said bore and in between filter body ends (the annular retainer 106 includes a bore or opening that is configured to receive the superior ends 104 of the filter legs 102 [0086, FIG. 12, FIGS. 14-15]. Furthermore, figure 12 illustrates the filter legs 102 being connected between filter body ends (e.g., upper and lower ends) of the filter orientation members 110 [FIG. 12]);
d) said one or more filtering elements including a hub at said central longitudinal axis (figures 12 and 17-18 illustrates the filter device 100 comprising an annular hub or spring 114 that is disposed along the central longitudinal axis “a” of the filter device 100 [0090, FIG. 12, FIGS. 17-18]) and multiple radially extending filtering arms that extend radially between said hub and said wall (figures 17-18 illustrates the filtering device 100 filtering arms or legs 102 that extends radially between the spring 114 (e.g., annular hub) and the filter orientation members 110 (e.g., wall panels) [0090, FIGS. 17-18]), wherein each arm connects to said hub and to a said wall panel in between said upper and lower edges (figures 12 and 17-18 illustrates the filter arms or legs 102 being connected to the spring 114 (e.g., annular hub) and the filter orientation members 110 (e.g., wall panels) [0090, FIGS. 17-18]. Specifically, figure 12 illustrates the filter arms or legs 102 being connected between the upper and lower edges of the filter orientation members 110 (e.g., wall panels) [FIG. 12]); and
e) said tubular body having anchors that prevent migration and/or tilting (the annular retainer 106 comprises filter legs 102 (e.g., round tubular wires) having respective hooks or barbs 32 which engages the wall of the vessel and prevents the filter device 100 from migrating [0025, 0085, 0087]. Furthermore, the filter orientation members 110 may also include hooks or barbs 32 to prevent the filter device 100 from migrating [0089]).
Regarding claim 13, O’Connell teaches wherein the body is of a resorbable material (the tubular body or annular retainer 106 is composed of a polylactic acid material or polyglycolic acid suture material [0087-0088, FIG. 12, FIG. 15]. The Examiner respectfully submits that polylactic acid material and polyglycolic acid suture material are known bioresorbable polymers [0088]).
Regarding claim 16, O’Connell teaches wherein the body and one or more filtering elements define a vena cava filter (the retainer 106 may be removed to convert the filter device 100 into an open stent-like configuration [0086, 0124]. Specifically, the open stent-like configuration may be used as a vena cava filter [0086, 0124]).
Regarding claim 18, O’Connell teaches wherein the body and one or more filtering elements define a convertible stent ([abstract]).
Regarding claim 19, O’Connell teaches wherein each filtering arm forms an acute angle with said central longitudinal axis ([0089, FIG. 12]).
Regarding claim 20, O’Connell teaches a vascular implant (the filter device 100 is configured to be implanted within a blood vessel [0003, 0085, FIG. 12]), comprising:
a) a tubular body of a polymeric material, having opposed filter body ends and a central longitudinal axis (the filter device 100 comprises a tubular or annular retainer 106 having filter legs (e.g., round tubular or flattened wires) [0085-0088, FIG. 12, FIGS. 14-15]. Specifically, figure 12 illustrates filter legs (e.g., round tubular wires) including filter orientation members 110 which have opposed filter body ends (e.g., upper end and lower end) [0085-0086, 0089, FIG. 12]. Furthermore, the annular retainer 106 of the filter device 100 is composed of a polylactic acid material or polyglycolic acid suture material [0086-0088, FIG. 12, FIG. 15]. Lastly, figure 12 illustrates the filter device 100 having a central longitudinal axis “a” [0086, 0089, FIG. 12]);
b) said body having a generally tubular segmented side wall that includes multiple spaced apart wall panels surrounding a central open ended bore (the filter device 100 comprises an annular retainer 106 having a bore or opening that is configured to receive superior ends 104 of the filter legs 102 (e.g., round tubular wires or flattened wires) [0085-0086, FIG. 12, FIGS. 14-15]. Furthermore, figures 12 and 18 illustrates each of the filter legs 102 including wall panels or filter orientation members 110 which are spaced apart and circumferentially surround the annular retainer 106 [0085-0086, 0089, FIG. 12, FIG. 18]. Lastly, the wall panels or filter orientation members 110 are configured to ensure centering of the filter device 100 in the vessel and to securely engage the filter device 100 with the interior wall of the blood vessel 28 [0089, FIG. 12]), each panel having spaced apart sides and spaced apart upper and lower edges (figure 12 illustrates the wall panels or filter orientation members 110 having an upper edge surface and a lower edge surface that are spaced apart [FIG. 12]. Furthermore, figure 12 illustrates the wall panels or filter orientation members 110 having left and right sides that are spaced apart [FIG. 12]);
c) said body including one or more filtering elements in said bore and in between filter body ends (the annular retainer 106 includes a bore or opening that is configured to receive the superior ends 104 of the filter legs 102 [0086, FIG. 12, FIGS. 14-15]. Furthermore, figure 12 illustrates the filter legs 102 being connected between filter body ends (e.g., upper and lower ends) of the filter orientation members 110 [FIG. 12]);
d) said one or more filtering elements including a hub at said central longitudinal axis (figures 12 and 17-18 illustrates the filter device 100 comprising an annular hub or spring 114 that is disposed along the central longitudinal axis “a” of the filter device 100 [0090, FIG. 12, FIGS. 17-18]) and multiple radially extending filtering arms that extend radially between said hub and said wall (figures 17-18 illustrates the filtering device 100 filtering arms or legs 102 that extends radially between the spring 114 (e.g., annular hub) and the filter orientation members 110 (e.g., wall panels) [0090, FIGS. 17-18]), wherein each arm connects to said hub and to a said wall panel in between said upper and lower edges (figures 12 and 17-18 illustrates the filter arms or legs 102 being connected to the spring 114 (e.g., annular hub) and the filter orientation members 110 (e.g., wall panels) [0090, FIGS. 17-18]. Specifically, figure 12 illustrates the filter arms or legs 102 being connected between the upper and lower edges of the filter orientation members 110 (e.g., wall panels) [FIG. 12]);
e) wherein said arms are spaced circumferentially apart (figures 17 and 18 illustrates the filter legs or arms 102 being spaced circumferentially apart [FIGS. 17-18]); and
f) said tubular body having anchors that prevent migration and/or tilting (the annular retainer 106 comprises filter legs 102 (e.g., round tubular wires) having respective hooks or barbs 32 which engages the wall of the vessel and prevents the filter device 100 from migrating [0025, 0085, 0087]. Furthermore, the filter orientation members 110 may also include hooks or barbs 32 to prevent the filter device 100 from migrating [0089]).
Claim Rejections - 35 USC § 103
6. 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.
7. Claims 3, 7-8, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over O’Connell in view of Montgomery (WO 2020/081814 A1, with citations to the corresponding US Publication No. 2022/0000600 A1).
Regarding claims 3 and 14, O’Connell teaches the vascular implant of claim 1 and claim 12. O’Connell does not explicitly teach wherein the body is of a material that is too soft to be machined.
The prior art by Montgomery is analogous to O’Connell, as they both teach an implantable filter system ([abstract, 0081]).
Montgomery teaches wherein the body is of a material that is too soft to be machined (according to Applicant’s specification, a material that is too soft to be machined would have durometer reading that is between 10 Shore A and 75 Shore D [specification: page 6, lines 14-23]. Specifically, Montgomery teaches polymer materials having a durometer that may range between 50 Shore A and 60 Shore D [0105]. Thus, Montgomery teaches polymers having a durometer that is too soft to be machined [0105]).
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 O’Connell’s vascular implant to comprise a material that is too soft to be machined, as taught by Montgomery. The advantage of such modification will improve the flexibility or elasticity of the device (see paragraphs [0103, 0105] by Montgomery).
Regarding claim 7, O’Connell teaches the vascular implant of claim 1. O’Connell does not explicitly teach wherein said polymeric material has a hardness that is a durometer reading of between about 35 Shore A and 75 Shore D.
However, Montgomery teaches wherein said polymeric material has a hardness that is a durometer reading of between about 50 Shore A and 80 Shore D ([0105]).
The Examiner respectfully submits that Montogmery’s durometer range (e.g., 50 Shore A to 80 Shore D) overlaps into the Applicant’s claimed range (e.g., 35 Shore A to 75 Shore D). Therefore, a prima facie case of obviousness exists. Based on the overlapping range, a person having ordinary skill in the art would have found it obvious to modify Montgomery’s durometer range to have a durometer that ranges between 35 Shore A and 75 Shore D (MPEP 2144.05). The advantage of such modification may improve to elasticity or flexibility of the device (see paragraphs [0103, 0105] by Montgomery).
Therefore, 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 O’Connell’s polymeric material to have a durometer reading between 35 Shore A and 75 Shore D, as suggested by Montgomery. The advantage of such modification may improve to elasticity or flexibility of the device (see paragraphs [0103, 0105] by Montgomery).
Regarding claims 8 and 15, Montgomery teaches wherein said polymeric material is too soft to be machined (according to Applicant’s specification, a material that is too soft to be machined would have durometer reading that is between 10 Shore A and 75 Shore D [specification: page 6, lines 14-23]. Specifically, Montgomery teaches polymer materials having a durometer that may range between 50 Shore A and 60 Shore D [0105]. Thus, Montgomery teaches polymers having a durometer that is too soft to be machined [0105]).
8. Claims 10 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over O’Connell in view of Sokolov et al. (US 2010/0063533 A1).
Regarding claims 10 and 17, O’Connell teaches the vascular implant of claims 1 and 12. O’Connell does not explicitly wherein the body and one or more filtering elements define an occlusion device.
The prior art by Sokolov is analogous to O’Connell, as they both teach a filter device that is positioned within a blood vessel ([abstract]). Sokolov teaches wherein the body and one or more filtering elements define an occlusion device ([0051]).
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 O’Connell’s body and filtering elements to define an occlusion device, as taught by Sokolov. The advantage of such modification will allow for adjusting the blood pressure within the vessel (see paragraphs [0049, 0051] by Sokolov).
Statement on Communication via Internet
9. 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
10. 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