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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nitzan et al. 2017/0216025.
Nitzan et al. discloses the invention as claimed noting for example figures 8a, 9A-9D comprising: A flow modifying implant that modifies a flow of blood in a vessel when deployed, the said flow modifying implant comprising:
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A method for modifying a flow of blood in a blood vessel, the method comprising:
deploying a flow modifying implant (110) in a blood vessel; anchoring the flow modifying implant into the blood vessel by radially expanding an anchor element into a wall of the blood vessel (the anchoring elements are the proximal and distal ends 102/106. See e.g. [0085] for expanded to a deployed state); causing the blood to flow through the flow modifying implant such that the flow of blood passes through an inflow end of the flow modifying implant, the inflow end having a larger cross-sectional area than an outflow end of the flow modifying implant (see [0018; 0020; 0047]); and modifying the flow of blood through the flow modifying implant (the modification is made because the implant addresses low ejection fraction heart failure, high and high pressures of the heart.
4. Claim(s) 1, 3, 6-11, 14-16, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shalev et al. 2003/0097172.
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Noting figure 9e Shalev et al. discloses a flow modifying implant (100) in a blood vessel; anchoring the flow modifying implant into the blood vessel by radially expanding an anchor element into a wall of the blood vessel (the anchoring elements are the proximal and distal ends ([0098] elements 200/202). See e.g. [0021] for expanded to a deployed state); causing the blood to flow through the flow modifying implant such that the flow of blood passes through an inflow end of the flow modifying implant, the inflow end having a larger cross-sectional area than an outflow end (see fig. 9e supra) of the flow modifying implant; and modifying the flow of blood through the flow modifying implant.
5. Regarding claims 3, 6 Shalev et al. discloses positioning the flow modifying implant across a portion of a coronary vein or a coronary sinus (see [0015; 0021; 0109]).
6. Regarding claim 7-11, the anchor element comprises a ring, (this is interpreted as the ring formed at both ends as seen in fig. 4C as seen below).
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the ring being coupled to a hollow tubular body, and wherein anchoring the flow modifying implant comprises radially expanding the ring into engagement with the wall of the blood vessel. Further see [0020-0021] for balloon expansion and [0031-0032] for self-expanding properties.
7. Regarding claims 14-15 see [0117] which list non-porous and porous materials.
8. Regarding claim 16 see [0031-0032].
9. Claim(s) 1 and 13, 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hossainy et al. 2015/0265438.
Hossainy et al. discloses a flow modifying implant (20) in a blood vessel; anchoring the flow modifying implant into the blood vessel by radially expanding an anchor element into a wall of the blood vessel (the struts act as anchoring elements see [0007] once the device is expanded in the wall of the passageway) causing the blood to flow through the flow modifying implant such that the flow of blood passes through an inflow end of the flow modifying implant, the inflow end having a larger cross-sectional area than an outflow end (see fig. 2) of the flow modifying implant; and modifying the flow of blood through the flow modifying implant (it is inherent that the flow is modified once an implant is placed because it restores normal blood flow by propping open blocked or narrowed arteries and veins pressing plaque away from the blood stream flow which by nature is the function of a stent).
Claim Rejections - 35 USC § 103
10. 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.
11. Claim(s) 2, 4-5, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Shalev et al. 2003/0097172.
12. Regarding claim 2, Shalev et al. does disclose implanting into a coronary sinus however does not superficially state an ostium (which is interpreted as an opening). It would have been obvious to one having ordinary skill in the art to modify the invention of Shalev et al. and position the implant at an ostium because [0119] contemplates delivery towards an opening (514) into a coronary sinus and tat in some patients a valve exists at an entrance of the coronary sinus.
13. Regarding claims 4-5, it is obvious if not inherent that blood vessels taper (For example, in coronary arteries, the lumen naturally narrows at an average rate of 0.22 mm for every 10 mm of length). It would be obvious to one having ordinary skill in the art to modify the invention of Shalev et al. and provide for the implant to be flush with the blood vessel in order to prevent further stenosis in the region of implantation .
14. Regarding claim 19 see [0187] which discloses “…a reducer with similar design may also be used in other veins, for example, popliteal, tibial or saphenous veins. In an exemplary embodiment of the invention, one or more reducers are implanted in popliteal veins, to increase back-pressure..” Therefore it would be obvious to modifying the flow of blood comprises creating a back pressure upstream of the flow modifying implant, wherein creating the back pressure upstream of the flow modifying implant increases blood flow to other anatomical locations.
Allowable Subject Matter
15. Claims 12, 17-18, 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
16. The following is a statement of reasons for the indication of allowable subject matter: The prior art does not disclose or teach the limitation of claim 1 in combination with a ring positioned on an inside of the hollow tubular body; or a hollow tubular body with ring positioned on an inside of the hollow tubular body; or modifying the flow of blood comprises increasing a pressure adjacent the inflow end of the flow modifying implant relative to a position along a tapered region between the inflow end and the outflow end; or modifying the flow of blood comprises increasing a velocity of the flow of blood adjacent a position along a tapered region of the flow modifying implant relative to the inflow end; or a lumen that forms an arcuate taper from the inflow to the outflow end.
Conclusion
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 June 25, 2026
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