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) 1-14 is/are pending. Claim(s) 14 is/are withdrawn.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 1/12/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/12/2026.
Information Disclosure Statement
The information disclosure statement filed 3/13/2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because citation EP 1353606 was not provided. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
All non-lined through citations were considered.
Claim Objections
Claims 2 and 5-6 are objected to because of the following informalities:
Claim 2, line 2 recites “the inner and outer”, which should be “the inner and the outer”.
Each of claim 5, lines 1-2 and claim 6, lines 1-2 recites “the electrospun inner and outer”, which should be “the electrospun inner and the electrospun outer”.
Appropriate correction is required.
Product By Process
The Examiner recognizes claims 1-2, 5-6, and 13 as a "product-by-process" claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113).
As a product claim, Examiner has determined claims 1-2, 5-6, and 13 require the graft device to comprise the following structural elements in addition to those in the claims from which they depend.
The language “electrospun” inner tubular layer and “electrospun” outer tubular layer imparts the structure of a mesh made of fibers.
This structure is required in addition to the remaining features claimed for each claim.
In the prior art rejection in this Office action, Examiner considers claims 1-2, 5-6, and 13 to be met when a reference teaches these structural limitations.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, line 11 recites the limitation "the corners". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “corners”.
Claim 1, lines 11-12 recites the limitation "the zig-zag pattern". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a zig-zag pattern of the zig-zag patterned helix”. Likewise, “the zig-zag pattern” in each of claim 1, line 14 and claim 7, line 3 lacks antecedent basis. This latter instance becomes moot when the first instance is corrected.
Claim 1, lines 13-14 recites the limitation "each V or inverted-V” within the zig-zag pattern. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “defined by V-shape or inverted-V-shape areas between struts of the zig-zag patten”.
Claim 4, line 2 recites “each V or inverted-V”. There is insufficient antecedent basis for this limitation in the claim. This rejection becomes moot when the similar issue in claim 1 is corrected.
The term "about" in claim 11, line 2 is a relative term which renders the claim indefinite. The term "about" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure provides no metric for determining the bounds of “about” (such as standard deviation or another metric). Therefore, this term is indefinite.
Claim 11, line 2 recites the limitation "the length". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a length”.
Claim 12, lines 2-3 recites the limitation "a predetermined state". It is unclear if this is the same or different predetermined state as that introduced earlier in claim 12. For purposes of examination the Examiner considers this language to be “the predetermined state”.
Claim(s) 2-3 and 5-10 are rejected as dependent from a rejected claim.
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, 5-6, 8-9, and 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eller, et al (US 2013/0085565 A1).
Regarding Claim 1, Eller teaches a graft device (e.g. Figures 5-6) for endogenous tissue restoration in between two tubular structures (), comprising:
(a) an electrospun inner tubular layer (e.g. abstract, Figures 6A-B, #220);
(b) an electrospun outer tubular layer (e.g. abstract, Figures 6A-B, #210); and
(c) a graft support device (e.g. abstract, Figures 6A-B, #110) defined as a zig-zag patterned helix (e.g. Figure 5) having an inner tubular surface and an outer tubular surface (e.g. Figure 5, luminal and abluminal surfaces of the graft support device, respectively),
wherein the electrospun inner tubular layer matches the inner tubular surface (e.g. Figure 6B), wherein the electrospun outer tubular layer matches the outer tubular surface (e.g. Figure 6B),
wherein together the electrospun inner tubular layer and the electrospun outer tubular layer sandwich the graft support device (e.g. Figure 6B),
wherein the graft support device distinguishes first areas defined by the corners of the zig- zag pattern (e.g. Figure 5, the crowns are the corners),
wherein the graft support device distinguishes second areas defined by areas within each V or inverted-V within the zig-zag pattern minus the first area defined as their respective corners (e.g. Figure 5, areas other than corners; areas between the struts),
wherein the first areas are non-laminated areas where the electrospun inner tubular layer and the electrospun outer tubular layer are not-laminated together (e.g. Figure 6A),
wherein the first non-laminated areas enable bending of the graft support device (the corners allow for compression and expansion of the stent by allowing the struts to be compressed closer to one another and when the compression is released the corners are able to open up upon expansion), while preventing kinking of the graft support device (the corners are not constrained by the electrospun layers and thus are able to bend freely relative to the condition where the corners are laminated by the electrospun layers; when not laminated, the corners move more freely, which results in less strain building up; more strain results in an increased likelihood of kinking; thus, the corners being unlaminated means the device is less likely to kink than a device that is laminated at the corners; further, kinking is prevented as most of the support frame is sandwiched in place between the electrospun layers and thus prevented from kinking), and
wherein the second areas are laminated areas where the electrospun inner tubular layer and the electrospun outer tubular layer are laminated together (e.g. Figure 6A).
Regarding Claim 5, the electrospun inner and outer tubular layer are each porous biodegradable polymer layers (e.g. [0069]) with a porosity large enough to allow for cell ingrowth upon implantation to promote the endogenous tissue restoration or growth (e.g. [0069]).
Regarding Claim 6, the electrospun inner and outer tubular layer are replaced over time by the endogenous tissue restoration or growth as a result of the cell ingrowth (e.g. [0069]).
Regarding Claim 8, the graft support device has a uniform pitch angle (e.g. Figure 5).
Regarding Claim 9, the graft support device at one end or at both ends has one or more independent C-rings distributed and positioned at an acute orientation angle relative to a longitudinal axis of the graft device (e.g. Figure 5).
Regarding Claim 11, the zig-zag patterned helix takes up about 95% of the length of the graft device (e.g. Figure 6, the helix extends 100% of the overall device’s length).
Regarding Claim 12, the graft device is deployable in a predetermined state or wherein the graft device maintains a predetermined state upon implantation (e.g. Figure 7, graft device is deployable in a predetermined state shown here; it is an expanded configuration).
Regarding Claim 13, Eller teaches a graft device (discussed supra for claim 1), comprising:
(a) an electrospun inner tubular layer (discussed supra for claim 1);
(b) an electrospun outer tubular layer (discussed supra for claim 1); and
(c) a graft support device (discussed supra for claim 1) defined as a patterned helix (discussed supra for claim 1) having an inner tubular surface and an outer tubular surface (discussed supra for claim 1),
wherein the electrospun inner tubular layer matches the inner tubular surface (discussed supra for claim 1),
wherein the electrospun outer tubular layer matches the outer tubular surface (discussed supra for claim 1), and
wherein together the electrospun inner tubular layer and the electrospun outer tubular layer sandwich the patterned helix distinguishing laminated areas and non-laminated areas (discussed supra for claim 1),
wherein the non-laminated areas enable bending of the patterned helix, while preventing kinking of the graft support device (discussed supra for claim 1).
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.
Claims 2 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eller, et al (US 2013/0085565 A1) as discussed supra, alone.
Regarding Claim 2, the graft support device is made out of a metal or a polymer (e.g. [0058], nitinol), wherein the electrospun inner and outer tubular layer are made out of polymer fibers (e.g. [0062], [0064] ePTFE fibers).
Eller discloses the invention substantially as claimed but fails to teach the second areas have a polymer to helix metal or helix polymer circumferential surface area ratio ranging from 4:1 to 12:1.
Eller teaches the diameter of the overall graft device is 4 mm to 40 mm (e.g. [0056]), the diameter of the support device wire is 0.005 inches to 0.02 inches (which is 0.127 mm to 0.508 mm) (e.g. [0058]), and that there are 16 sections of wire in a circumferential cross-section (e.g. Figure 6B).
The surface area of a cylinder is equal to 2prh + 2pr2. For a unit height (1 mm), the surface area of the overall graft device ranges from 38 mm2 to 2639 mm2. The surface area of one support device wire ranges from 0.9 mm2 to 4.81 mm2, and for 16 wire sections the combined surface area is 14.4 mm2 to 76.96 mm2. At the surface Figure 6B suggests about one quarter of the surface of the wire is at the overall graft device’s surface and thus the contribution of the wires to the overall surface area is approximately, 3.6 mm2 to 19.24 mm2. The amount of polymer from the electrospun layer second areas is the total surface area less the wire surface area, which ranges from 18.8mm2 to 2635 mm2. The ratio of second area polymer to helix metal is thus 18.8:19.2 to 2635:3.6, which is 0.98:1 to 732:1.
Eller is concerned with the same field of endeavor as the claimed invention, namely stent grafts having helically wound support device partially sandwiched between layers of electrospun polymer.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Eller such that the second areas have a polymer to helix metal or helix polymer circumferential surface area ratio ranging from 4:1 to 12:1 as taught by Eller 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).
Regarding Claim 10, Eller discloses the invention substantially as claimed but fails to teach the graft support device at one end or at both ends have a closed ring connected to the graft support device.
Eller teaches in another embodiment a helically wound support device having ends closed where the wire overlaps itself (e.g. Figures 1, 2B).
Eller is concerned with the same field of endeavor as the claimed invention, namely stent grafts having helically wound support device partially sandwiched between layers of electrospun polymer.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embodiment of Figures 5-6 such that the end is closed as taught by Eller in the embodiment of Figures 1, 2B as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143(I)) of a support frame that supports the electrospun layers which allow for ingrowth to anchor the overall device at the implantation site (e.g. Eller, [0028]).
Claims 3-4 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eller, et al (US 2013/0085565 A1) as discussed supra and further in view of Bales, et al (Bales) (US 2006/0064158 A1).
Regarding Claim 3, Eller discloses the invention substantially as claimed but fails to teach the first non-laminated area for each corner has a surface area in a range of 0.3 to 0.5 mm2.
Bales teaches a helical stent having a strut length of 0.99 mm (e.g. [0028]).
Eller and Bales are concerned with the same field of endeavor as the claimed invention, namely helical stents.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Eller such that the strut length is that as taught by Bales in order to provide resistance to buckling in bending or torsion (e.g. Bales, [0031]).
The combination of Eller and Bales discloses the invention substantially as claimed but fails to teach the first non-laminated area for each corner has a surface area in a range of 0.3 to 0.5 mm2.
Eller further teaches that approximately one-third the length of the strut extends in the non-laminated portion (e.g. Eller, Figure 7) and the diameter of the support device wire is 0.005 inches to 0.02 inches (which is 0.127 mm to 0.508 mm) (e.g. [0058]).
Each corner has two cylinders up to the bend having surface areas of a cylinder, which is equal to 2prh + 2pr2. With Bales’s length the surface area of the two cylinders is a range of 2*p*(0.0635)(0.33)+2*p*(0.0635)2 to 2*p*(0.254)(0.33)+2*p*(0.254)2 = 0.32 mm2 to 5.34 mm2.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Eller and Bales such that the first non-laminated area for each corner has a surface area in a range of 0.3 to 0.5 mm2 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).
Regarding Claim 4, Eller discloses the invention substantially as claimed but fails to teach the second laminated area within each V or inverted-V has a surface area in a range of 2.5 to 3.5 mm2.
Bales teaches a helical stent having a strut length of 0.99 mm (e.g. [0028]).
Eller and Bales are concerned with the same field of endeavor as the claimed invention, namely helical stents.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Eller such that the strut length is that as taught by Bales in order to provide resistance to buckling in bending or torsion (e.g. Bales, [0031]).
The combination of Eller and Bales discloses the invention substantially as claimed but fails to teach the second laminated area within each V or inverted-V has a surface area in a range of 2.5 to 3.5 mm2.
Eller further teaches that approximately two-third the length of the strut is in the laminated portion (e.g. Eller, Figure 7), the diameter of the overall graft device is 4 mm to 40 mm (e.g. [0056]), the diameter of the support device wire is 0.005 inches to 0.02 inches (which is 0.127 mm to 0.508 mm) (e.g. [0058]), there are 16 struts and 16 gaps between struts (e.g. Figure 6B), and that at the surface Figure 6B suggests about one quarter of the surface of the wire is at the overall graft device’s surface.
The total surface area of the cylinder at the laminated portion is that of the cylinder having a length of 0.66 mm and diameter of 4 mm to 40 mm. The surface area of a cylinder is equal to 2prh + 2pr2. Thus, the total surface area range is 33 mm2 to 2596 mm2. The surface area of the wire of the support device is that of the cylindrical wire, which is a range of 0.29 mm2 to 1.46 mm2 per wire. For 16 wires have approximately one-quarter of their surface area on the overall surface of the device the device surface area contribution from the wires is that of the single wire x16÷4, which is 1.16 mm2 to 5.84 mm2. The area of a single gap is (total surface area minus the contribution from the wires) ÷ 16, which is 1.7 mm2 to 162 mm2. The area of a single gap is the surface area of the second laminated area for each V or inverted-V.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Eller and Bales such that the second laminated area within each V or inverted-V has a surface area in a range of 2.5 to 3.5 mm2 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).
Regarding Claim 7, each corner within the graft support device is an n-like shape or a u-like shape depending on the direction within the zig-zag pattern (e.g. Figure 6A).
Eller discloses the invention substantially as claimed but fails to teach each corner has a surface area in a range of 0.3 to 0.5 mm2.
Bales teaches a helical stent having a strut length of 0.99 mm (e.g. [0028]).
Eller and Bales are concerned with the same field of endeavor as the claimed invention, namely helical stents.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Eller such that the strut length is that as taught by Bales in order to provide resistance to buckling in bending or torsion (e.g. Bales, [0031]).
The combination of Eller and Bales discloses the invention substantially as claimed but fails to teach the first non-laminated area for each corner has a surface area in a range of 0.3 to 0.5 mm2.
Eller further teaches that approximately one-third the length of the strut extends in the non-laminated portion (e.g. Eller, Figure 7) and the diameter of the support device wire is 0.005 inches to 0.02 inches (which is 0.127 mm to 0.508 mm) (e.g. [0058]).
Each corner has two cylinders up to the bend having surface areas of a cylinder, which is equal to 2prh + 2pr2. With Bales’s length the surface area of the two cylinders is a range of 2*p*(0.0635)(0.33)+2*p*(0.0635)2 to 2*p*(0.254)(0.33)+2*p*(0.254)2 = 0.32 mm2 to 5.34 mm2.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Eller and Bales such that the first non-laminated area for each corner has a surface area in a range of 0.3 to 0.5 mm2 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).
Relevant Prior Art
US 6,364,904 B1 to Smith teaches a helically wound zig-zag patterned support device where each row of struts is partially laminated between layers of graft material (e.g. Figures 3-4).
US 2003/0130721 A1 to Martin, et al teaches a helically wound zig-zag patterned support device (e.g. Figure 13A) where each row of struts is partially laminated between layers of graft material (e.g. Figures 9-10).
US 2004/0162603 A1 to Golds, et al teaches a support device completely encapsulated by laminated graft layers (e.g. Figure 1).
Conclusion
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.
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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 2/3/2026