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 .
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.
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) 1-7, 9, 11-14, 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval (20190239998 ) in view of Shalev (20140324154).
With regards to claim 1, Tuval discloses a flow modulator device for altering fluid flow through a body lumen (20/24, [0009]), the body lumen coupled to a branch lumen (FIG 1), the flow modulator device comprising: a stent (24) configured to be positioned within the body lumen (FIG 1), the stent (24) comprising an upstream component (24) having an inlet (see annotated FIG 1), an outlet (see annotated FIG 1), and a cross-sectional flow area that converges from the inlet towards the outlet to form a nozzle (34), a downstream component (30) having an entry (see annotated FIG 1), an exit (see annotated FIG 1), and a cross-sectional flow area that diverges from the entry towards the exit (see annotated FIG 1), and an entrainment region between the inlet of the upstream component and the exit of the downstream component (see annotated FIG 2), the entrainment region comprising one or more openings (36), wherein the nozzle is configured to accelerate a fluid stream passing through the upstream component towards the downstream component (the nozzle is configured to do this, as fluids accelerate is small diameters) to generate a low pressure region in a vicinity of the entrainment region that entrains additional fluid into the fluid stream via the one or more openings as the fluid stream passes into the downstream component ([0100]). Tuval fails to disclose at least a portion of the nozzle configured to be radially expandable responsive to pressure upstream of the flow modulator device within the body lumen.
Shalev, in the same field of art, discloses a stent-graft (20) with an upstream component (40), a downstream component (42), and a nozzle (34, as a nozzle is interpreted as an area that changes fluid flow by having a different diameter). Shalev teaches that at least a portion of the nozzle is configured to be radially expandable responsive to pressure upstream of the flow modulator device within the body lumen ([0077], where portion 34 has a different radius based on different blood pressures). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval’s flow modulator device to include at least a portion of the nozzle configured to be radially expandable responsive to pressure upstream of the flow modulator device within the body lumen, as taught by Shalev, in order to allow for the flow modulator device to adapt to changes in pulse profile and more effectively propagate the pulse, facilitating better entrainment ([0004]).
PNG
media_image1.png
420
316
media_image1.png
Greyscale
PNG
media_image2.png
635
530
media_image2.png
Greyscale
With regards to claim 2, Tuval as modified by Shalev discloses the flow modulator device of claim 1, Tuval further teaches wherein the upstream component (26) and the downstream component (30) are formed from a frame (24), and are at least partially coated (FIG 1) with a biocompatible material ([0038]), thereby exposing the one or more openings and defining the inlet (26, FIG 1).
With regards to claim 3, Tuval as modified by Shalev discloses the flow modulator device of claim 2, Shalev further teaches wherein the radially expandable portion of the nozzle (34) is formed by a continuous passageway of biocompatible material (26, [0133]) extending through the flow modulator device within an uncoated portion of the frame (FIG 1A, 24), the continuous passageway of biocompatible material (26, [0133]) having an outer diameter less than an inner diameter of the uncoated portion of the frame ([0131], where if member 26 is attached to an internal surface of stent 24, then it must have a lesser diameter), such that the continuous passageway of biocompatible material radially expands toward the uncoated portion of the frame responsive to pressure upstream of the flow modulator device within the body lumen ([0077]).
With regards to claim 4, Tuval as modified by Shalev discloses the flow modulator device of claim 2, Shalev further teaches wherein the radially expandable portion of the nozzle (34) is formed by a coated portion of the frame having more flexibility than other portions of the frame, such that it radially expands responsive to pressure upstream of the flow modulator device within the body lumen (FIG 1A, FIG 1B, given that only portion 34 expands with the same imparted fluid pressure, it must have more flexibility than other portions).
With regards to claim 5, Tuval as modified by Shalev discloses the flow modulator device of claim 4, Shalev further teaches wherein the coated portion of the frame having more flexibility than other portions of the frame (FIG 1A, FIG 1B, given that only portion 34 expands with the same imparted fluid pressure, it must have more flexibility than other portions) comprises thin Nitinol wires ([0132]).
With regards to claim 6, Tuval as modified by Shalev discloses the flow modulator device of claim 4, Shalev further teaches wherein the biocompatible material (26, [0133]) coating the portion of the frame having more flexibility than other portions of the frame (34) is configured to radially expand beyond an outer diameter of the frame responsive to pressure upstream of the flow modulator device within the body lumen (FIG 1B).
With regards to claim 7, Tuval as modified by Shalev discloses the flow modulator device of claim 2, Shalev further teaches wherein the radially expandable portion of the nozzle (34) is formed by a continuous passageway of biocompatible material (26, [0133]) extending along a frameless portion of the flow modulator device (see annotated figure below) between the frame forming at least a portion of the upstream component (40) and the frame forming the downstream component (42), such that the continuous passageway of biocompatible material radially expands responsive to pressure upstream of the flow modulator device within the body lumen ([0077]).
PNG
media_image3.png
494
363
media_image3.png
Greyscale
With regards to claim 9, Tuval as modified by Shalev discloses the flow modulator device of claim 2, Tuval further teaches wherein the frame defines a plurality of cells (FIG 2).
With regards to claim 11, Tuval as modified by Shalev discloses the flow modulator device of claim 2, Tuval further teaches wherein at least a portion of a distal portion of the downstream component is not coated with the biocompatible material (FIG 2), the distal portion configured to adapt with the body lumen to thereby prevent migration of the flow modulator device within the body lumen ([0099]).
With regards to claim 12, Tuval as modified by Shalev discloses the flow modulator device of claim 1, Shalev further teaches wherein the radially expandable portion of the nozzle (34) is configured to radially expand responsive to pressure upstream of the flow modulator device within the body lumen ([0077]) without causing expansion of portions of the upstream and downstream components that engage the body lumen (FIG 1B).
With regards to claim 13, Tuval as modified by Shalev discloses the flow modulator device of claim 1, Tuval further teaches wherein the stent (24) is configured to transition from a collapsed delivery state to an expanded deployed state within the body lumen ([0098]).
With regards to claim 14, Tuval as modified by Shalev discloses the flow modulator device of claim 1, Tuval further teaches wherein the one or more openings (36) comprises a plurality of openings radially spaced around the entrainment region (FIG 2).
With regards to claim 30, Tuval as modified by Shalev discloses the flow modulator device of claim 1, Tuval further teaches wherein the downstream component comprises a diffuser (30, FIG 1) that decelerates the fluid stream having the entrained additional fluid passing through the downstream component (FIG 1; the fluid passing into an area with a larger diameter will be decelerated).
With regards to claim 31, Tuval as modified by Shalev discloses the flow modulator device of claim 1, Tuval further teaches wherein the entrainment region (see annotated FIG 2) is integrally formed with the downstream component (FIG 2).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval (20190239998) in view of Shalev (20140324154), as applied to claim 9 above, and further in view of DiCarlo (20030009211).
With regards to claim 10, Tuval as modified by Shalev disclose the flow modulator device of claim 9, but fail do disclose wherein at least some cells of the plurality of cells adjacent to at least one of the inlet of the upstream component or the exit of the downstream component comprises an oval shape, the at least some cells comprising a preformed bend configured to extend outwardly to secure the flow modulator device within the body lumen.
DiCarlo, in the same field of art, discloses a device (100) with cells (FIG 5A) and configured to be positioned within the body lumen ([0027]). DiCarlo teaches wherein at least some cells of the plurality of cells (FIG 5A) adjacent to at least one of the inlet of the upstream component or the exit of the downstream component comprises an oval shape (224), the at least some cells comprising a preformed bend configured to extend outwardly (FIG 5A) to secure the flow modulator device within the body lumen ([0035]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Yacoby’s flow modulator device to include wherein at least some cells of the plurality of cells adjacent to at least one of the inlet of the upstream component or the exit of the downstream component comprises an oval shape, the at least some cells comprising a preformed bend configured to extend outwardly to secure the flow modulator device within the body lumen, as taught by DiCarlo, in order to secure the device in place ([0035]).
Claim(s) 15, 21, 26, 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval (20190239998) in view of Shalev (20140324154) and further in view of Celermajer (20250177115).
With regards to claim 15, Tuval as modified by Shalev discloses the flow modulator device of claim 1, but fails to disclose wherein at least one of the upstream or the downstream component comprises a plurality of fixation elements extending outwardly therefrom to secure the flow modulator device within the body lumen.
Celermajer, in the same field of art, discloses a blood vessel implant with an upstream and a downstream component (FIG 4B). Celermajer teaches that both the upstream and the downstream component comprises a plurality of fixation elements (204) extending outwardly therefrom (FIG 4B) to secure the device within the body lumen ([0131]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval’s flow modulator device to include wherein the downstream component comprises a plurality of fixation elements extending outwardly therefrom to secure the flow modulator device within the body lumen, as taught by Celermajer, in order to prevent migration after implantation in a body.
With regards to claim 21, Yacoby as modified by Shalev discloses the flow modulator device of claim 1, but fails to disclose wherein the upstream component comprises a retrieval portion configured to facilitate retrieval of the flow modulator.
Celermajer, in the same field of art, discloses a blood vessel implant with an upstream and a downstream component (FIG 4B). Celermajer teaches that the upstream component comprises a upstream retrieval portion (618, [0141]) configured to facilitate retrieval of the flow modulator ([0140]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval’s flow modulator device to include that the upstream component comprises a upstream retrieval portion configured to facilitate retrieval of the flow modulator, as taught by Celermajer, in order to allow the catheter to controllably attach to the implant ([0140]).
With regards to claim 26, Tuval as modified by Shalev discloses the flow modulator device of claim 1, but fails to disclose wherein the downstream component comprises a downstream retrieval portion configured to facilitate retrieval of the flow modulator.
Celermajer, in the same field of art, discloses a blood vessel implant with an upstream and a downstream component (FIG 4B). Celermajer teaches that the downstream component comprises a downstream retrieval portion (618) configured to facilitate retrieval of the flow modulator ([0140]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval’s flow modulator device to include that the downstream component comprises a downstream retrieval portion configured to facilitate retrieval of the flow modulator, as taught by Celermajer, in order to allow the catheter to controllably attach to the implant ([0140]).
With regards to claim 32, Tuval as modified by Shalev fails to disclose a delivery system configured to deliver the flow modulator device of claim 1, the delivery system comprising: a delivery catheter comprising one or more holders configured to be releasably coupled to the flow modulator device in a collapsed delivery state.
Celermajer, in the same field of art, discloses a blood vessel implant with an upstream and a downstream component (FIG 4B). Celermajer teaches a delivery system configured to deliver said blood vessel implant, the delivery system comprising: a delivery catheter (604) comprising one or more holders (618) configured to be releasably coupled to the flow modulator device in a collapsed delivery state ([0140]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval’s flow modulator device to include a delivery system configured to deliver the flow modulator device of claim 1, the delivery system comprising: a delivery catheter comprising one or more holders configured to be releasably coupled to the flow modulator device in a collapsed delivery state, as taught by Celermajer, in order to be able to place the flow modulator device in a patient’s body.
With regards to claim 33, Tuval as modified by Shalev and Celermajer and discloses the delivery system of claim 32, Celemajer further teaches that it is further comprising: a sheath ([0142]) configured to be disposed over the delivery catheter and flow modulator device ([0142]) to maintain the flow modulator in the collapsed delivery state ([0142]), wherein, upon retraction of the sheath relative to the delivery catheter to expose the flow modulator device, the flow modulator device transitions to an expanded deployed state ([0142]).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval (20190239998) in view of Shalev (20140324154) and further in view of Schwammenthal (20060149360).
With regards to claim 25, Yacoby as modified by Shalev discloses the flow modulator device of claim 1, but fails to disclose wherein the downstream component comprises a first diverging portion and a second diverging portion downstream from the first diverging portion, the second diverging portion's average angle of divergence greater than the first diverging portion's average angle of divergence.
Schwammenthal, in the same field of art, discloses a flow modulator device (FIG 2) with a downstream component. Schwammenthal teaches that the downstream component comprises a first diverging portion and a second diverging portion downstream from the first diverging portion (component 5 in FIG 2 can be split into a first and second portion), the second diverging portion's average angle of divergence greater than the first diverging portion's average angle of divergence ([0043], where component 5 can be convex, which could cause the second diverging portion for have a larger average angle of divergence). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval’s flow modulator device to include that the downstream component comprises a first diverging portion and a second diverging portion downstream from the first diverging portion, the second diverging portion's average angle of divergence greater than the first diverging portion's average angle of divergence, as taught by Schwammenthal, in order to further decrease velocity and pressure ([0042]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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, Melanie Tyson can be reached at (571) 272-9062. 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.
/R.F.N./Patent Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
Prosecution Insights