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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 2-20 is/are pending. Claim(s) 1 is/are canceled.
Allowable Subject Matter
Claims 15-16 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.
Response to Arguments
Applicant’s arguments, filed 5/6/2026, with respect to the Double Patenting Rejections of US 11,497,503 have been fully considered and are persuasive. These Double Patenting rejections of claims 2, 5-6, and 13 has/have been withdrawn due to Applicant’s amendments.
Applicant’s arguments, filed 5/6/2026, with respect to the Double Patenting Rejections of US 11,723,783 have been fully considered and are persuasive. These Double Patenting rejections of claims 2-6 and 8-20 has/have been withdrawn due to the Applicant’s filing of a Terminal Disclaimer and its approval on 5/6/2026.
Applicant’s arguments, filed 5/6/2026, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections of claim 19 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments with respect to claim(s) 2-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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) 2-9, 11-14, 17-18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chin, et al (Chin) (US 2017/0056175 A1).
Regarding Claim 2, Chin teaches a flow modifying apparatus (e.g. Figures 13-14) comprising:
a plurality of struts coupled together to form a radially expandable frame having a first end portion and a second end portion (e.g. Figures 13-14, [0068], abstract), wherein the first end portion and the second end portion are radially expandable into expanded first and second end portions, respectively (e.g. Figures 13-14), wherein the flow modifying apparatus extends from a first end of the radially expandable frame to a second end of the radially expandable frame (e.g. Figures 13-14);
a reduced diameter portion of the expandable frame disposed between the first end portion and the second end portion (e.g. Figures 13-14, wherein the reduced diameter portion comprises a fluid flow through passage (e.g. abstract, [0007]), wherein when the first and second end portions have expanded into the expanded first and second end portions, the first and second expanded end portions each comprise flared portions that flare outwardly from the reduced diameter portion toward the first and second ends, respectively, of the radially expandable frame (e.g. Figures 13-14); and
a cover covering at least a portion of the flared portion of the first end portion (e.g. Figures 13-14, #26), wherein the cover is spaced from the reduced diameter portion (e.g. annotated Figure 13A below) and the reduced diameter portion is uncovered (e.g. Figures 13-14), wherein the reduced diameter portion modifies fluid flow therethrough immediately upon implantation thereof and forms a pressure gradient between the first end and the reduced diameter portion of the expandable frame (e.g. Figure 13A, these functions inherently result from the shape of the apparatus per fluid mechanics principles; specifically, fluid flow velocity inherently increases when a tube narrows and there is a pressure gradient per Bernoulli's equation for a narrowed tube relative to a larger diameter tube).
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Annotated Figure 13A, Chin
Regarding Claim 3, the pressure gradient is greatest between the first end of the apparatus and the reduced diameter portion (e.g. Figure 13A, the first end, covered, has the largest diameter and the difference between this diameter section and the smallest represents the greatest pressure difference; the Examiner notes there is no requirement there be only one region of greatest diameter/pressure difference; rather the requirement is that there is no greater pressure differential, which is the case between each location having the greatest diameter relative to the smallest diameter).
Regarding Claim 4, a velocity of the fluid flow is greatest in the reduced diameter portion (e.g. Figures 13-14, the reduced diameter has the smallest diameter and thus the highest velocity, which is inherently present, see Bernoulli’s principle).
Regarding Claim 5, the cover is disposed over an outer surface of the radially expandable frame (e.g. [0054], the membrane is against the vein and thus on the outer surface of the frame).
Regarding Claim 6, the cover is disposed over an inner surface of the radially expandable frame (discussed supra for claim 5; the radially outer position is considered “over” the inner surface).
Regarding Claim 7, there is a second cover covering at least a portion of the flared portion of the second end portion, wherein the second cover is spaced from the reduced diameter portion (e.g. [0054], Figures 13-14).
Regarding Claim 8, the cover comprises a polymer, a fabric, a synthetic material, tissue, or combinations thereof (e.g. [0054]).
Regarding Claim 9, the cover is configured to prevent or minimize an inflammatory response by a vessel wall (e.g. [0050], although heparin is typically indicated as an anti-coagulant, it also has anti-inflammatory properties and thus serves the claimed function).
Regarding Claim 11, the plurality of struts form a plurality of rectangular slots when the expandable frame is in a collapsed configuration, and wherein the plurality of rectangular slots expand into diamond shapes when the expandable frame is in a radially expanded configuration, and wherein the diamond shapes have a height and a length, and wherein the height decreases from the first and second ends toward a center point disposed therebetween (e.g. Figures 13-14, when collapsed the diamond shapes form rectangular slots), and wherein the diamond shapes have a height and a length (diamond shapes inherently have these dimensions), and wherein the height decreases from the first and second ends toward a center point disposed therebetween (upon expansion the height of each diamond decreases in the axial direction and this from first and second ends and toward the axial center of the overall device because the diamond's longer dimension is oriented in this direction).
Regarding Claim 12, wherein the length decreases from the first and second ends toward the center point (discussed supra for claim 11; as the frame is made of diamond shapes the length of the stent decreases as it expands due to these shapes).
Regarding Claim 13, the flow modifying apparatus is self-expanding or balloon expandable (e.g. [0010]).
Regarding Claim 14, the cover extends over up to 40% of a length of the flow modifying apparatus (e.g. e.g. [0054], when both the first and second ends are covered; Figure 13-14).
Regarding Claim 17, one of the first and second ends is smaller than the other of the first and second ends (e.g. annotated Figure 13A above; as broadly claimed, there is no requirement for what elements are being compared in each end; thus the smaller diameter portion of one end is smaller than the largest diameter portion of the other end meets the claim requirement).
Regarding Claim 18, the first portion is an outflow portion of the apparatus and the second portion is an inflow portion of the apparatus (e.g. Figures 13-14, [0054] when both ends are covered; one end must be the outflow and the opposing end the inflow end).
Regarding Claim 20, Chin teaches a system for delivering a flow modifying implant (see following), said system comprising: the flow modifying implant of claim 2 (discussed supra for claim 2); and a delivery catheter (e.g. [0014], [0017]).
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 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chin, et al (Chin) (US 2017/0056175 A1) as discussed supra, alone.
Regarding Claim 10, Chin discloses the invention substantially as claimed but fails to teach the reduced diameter portion comprises a diameter between 2 to 4 mm ().
Chin teaches the diameter ranges from 1 mm to 30 mm (e.g. [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chin such that the reduced diameter portion comprises a diameter between 2 to 4 mm since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Claim 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chin, et al (Chin) (US 2017/0056175 A1) as discussed supra and further in view of Fogarty, et al (Fogarty) (US 5,824,037).
Regarding Claim 19, Chin discloses the invention substantially as claimed but fails to teach the cover extends up to the first end of the radially expandable frame.
Fogarty teaches a covering that extends up to the first end of the radially expandable frame (e.g. Figure 3B, the cover is at the terminal end of the frame portions other than the tips and is generally at the "end" of the frame as required by the claim).
Fogarty and Chin are concerned with the same field of endeavor as the claimed invention, namely stent grafts having larger diameter ends relative to a reduced diameter portion located between these ends.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chin such that the cover extends up to the first end of the radially expandable frame as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143(I)) of providing the sealing function of Chin (e.g. [0054]) at end portions and terminal ends of the stent graft.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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, THOMAS BARRETT can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 6/9/2026
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