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) 16-35 is/are pending. Claim(s) 1-15 is/are canceled.
Response to Arguments
Applicant’s arguments, filed 10/17/2025, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims 20, 22, 28-33, and 35 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments with respect to claim16-35 have been considered but are moot in view of the new grounds of rejection. The Examiner notes the change in prior art was necessitated by the Applicants amendments.
Applicant only argues that the amended language is not taught by the prior art as cited and Xie cannot be modified to include the amended claim language.
The Examiner notes that although the previously cited prior art is reused herein, it has been combined differently due to Applicant’s amendments.
Xie is not used herein for teaching a tubular device having layers adhered together with an adhesive.
Product By Process
The Examiner recognizes claim(s) see Table I below 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 claim(s) see Table I below require the tubular structure to comprise the following structural elements in addition to those in the claims from which they depend: see Table I below.
In the prior art rejection in this Office action, Examiner considers claim(s) see Table I below to be met when a reference teaches these structural limitations.
Table I
Claim
Language
Imparted Structure
1
by applying fibrin glue
A layer of fibrin glue between adjacent layers of the biological tissue
28
obtained by rolling a rectangular or substantially rectangular sheet of biological tissue having a tapered edge portion into a tubular shape
Tubular body of the biological tissue
28
and fixing the tapered edge portion to an inner wall of the tubular structure
Tubular body of the biological tissue
28
by applying fibrin glue
A layer of fibrin glue between adjacent layers of the biological tissue
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 16, 21-25, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hinds, et al (Hinds) (US 2006/0257447 A1) in view of Xie, et al (Xie) (US 2003/0181968 A1).
Regarding Claim 16, Hinds teaches a tubular structure (e.g. Figures 1-2) comprised of a rectangular or substantially rectangular sheet of biological tissue (e.g. [0027]; [0095]-[0096]),
the layers of biological tissue are fixed to each other forming the tubular structure by applying fibrin glue (e.g. [0020]).
Hinds discloses the invention substantially as claimed but fails to teach wherein the sheet of biological tissue comprises on at least one side a tapered edge portion thinning down in a thickness direction, towards an end thereof and
wherein the tapered edge portion of the sheet of biological tissue is positioned on an inner side and fixed to an inner wall of the tubular structure.
Xie teaches a tubular structure comprised of a rectangular or substantially rectangular sheet of biological tissue (e.g. Figures 4-6, #30 is rectangular or substantially rectangular prior to being rolled; [0037], biomaterial, [0031], biological tissue), wherein the sheet of biological tissue comprises on at least one side a tapered edge portion thinning down in a thickness direction (e.g. Figure 6, edge at the luminal surface; annotated Figure 4 below, thickness direction), towards an end thereof (e.g. Figure 6), and wherein the tapered edge portion of the sheet of biological tissue is positioned on an inner side and fixed to an inner wall of the tubular structure (e.g. Figure 6).
Xie and Hinds are concerned with the same field of endeavor as the claimed invention, namely implants made from planar sheets of material rolled into tubular structures.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hinds by incorporating the tapered edge and its connection when the tubular structure is formed as taught by Xie in order to as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143(I)) of a known sheet shape used to wrap into a tubular structure (know per Xie, e.g. [0062], Figure 6). Here, the substituted elements function is known to function as a shape able to be wrapped into a tubular stent structure (e.g. Xie, Figure 6, abstract).
Regarding Claim 21, the tapered edge has a slanting shape on one face of the sheet (e.g. Xie, Figure 6).
Regarding Claim 22, a tissue material of the biological tissue is an animal blood vessel (e.g. Hinds, [0020]).
Regarding Claim 23, the sheet of biological tissue is decellularized tissue (e.g. Hinds, [0020]-[0021], acellular).
Regarding Claim 24, at least a part of a wall portion of the tubular structure has a two-layer structure (e.g. Hinds, Figures 1-2).
Regarding Claim 25, the tapered edge portion is adhered and fixed to the inner wall of the tubular structure (e.g. Xie, [0040], [0055]).
Regarding Claim 34, the combination of Hinds and Xie teaches an artificial blood vessel comprising the tubular structure of claim 16 (e.g. Hinds, abstract).
Claim 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hinds, et al (Hinds) (US 2006/0257447 A1) in view of Xie, et al (Xie) (US 2003/0181968 A1) as discussed supra and further in view of Giungo (US 5,817,075).
Regarding Claim 17, the combination of Hinds and Xie discloses the invention substantially as claimed but fails to teach an angle of the tapered edge is in a range of 27o to 52o.
Giungo teaches a planar sheet rolled into an implant (e.g. abstract, Figures 13-15) where the angle of the taper is acute (0o to 90o) (e.g. column 6, lines 54-67).
Giungo and the combination of Hinds and Xie are concerned with the same field of endeavor as the claimed invention, namely implants made from planar sheets of material rolled into tubular structures.
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 Hinds and Xie such that the tapered edge is in a range of 27° to 52° 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). Further, Giungo teaches having said taper angle in order to produce a graft having approximately parallel sides and to facilitate sliding of the graft material over the material it contacts.
Regarding Claim 18, a thickness of the sheet is 173 to 660 micrometers (e.g. Hinds, [0082], 100 mm to 1mm (1000 mm)).
The combination of Hinds, Xie, and Giungo is concerned with the same field of endeavor as the claimed invention, namely implants made from planar sheets of material rolled into tubular structures.
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 Hinds, Xie, and Giungo by incorporating the angle as taught by Hinds such 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 19, the at least one side (that has the tapered edge) of the sheet is in a length direction (e.g. Xie, annotated Figure 4 below; the at least one side extends in the length direction).
Claim 20, 27-33, and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hinds, et al (Hinds) (US 2006/0257447 A1) in view of Xie, et al (Xie) (US 2003/0181968 A1) in view of Giungo (US 5,817,075) as discussed supra and further in view of Woodroof (US 4,502,159).
Regarding Claim 20, the combination of Hinds, Xie, and Giungo discloses the invention substantially as claimed but fails to teach a length of the at least one side in the length direction of the sheet is 10 to 400 millimeters and a length of one side in a width direction of the sheet is 1.5 to 200 millimeters.
Woodroof teaches a vascular implant made of a sheet of material made into a tubular body (e.g. abstract, Figure 1-2, 8-9) where the length and width are at least 1.5 cm (15 mm) (e.g. column 2, lines 51-63).
Woodroof and the combination of Hinds, Xie, and Giungo are concerned with the same field of endeavor as the claimed invention, namely implants made from planar sheets of material rolled into tubular structures.
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 Hinds, Xie, and Giungo such that the length and width of the sheet is at least 15 mm as taught by Woodroof 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 27, here, this claim is considered to be rejected under the combinations made for claim 20 (which includes claims 17-19, from which claim 20 depends). Thus, claim 27 has the combination of parameters of claims 17, 18, and 20. With this combination of dimensions, the tubular structure has a pressure resistance of 400 mmHg or higher (per Applicant’s Specification at e.g. [0015], [0017], [0066], the combination of the parameters in claims 17-18 and 20, plus the tapered shape of claim 16 results in the claimed pressure resistance).
Regarding Claim 28, the combination of Hinds, Xie, Giungo, and Woodroof teaches a tubular structure (discussed supra for claim 16), obtained by rolling a rectangular or substantially rectangular sheet of biological tissue having a tapered edge portion into a tubular shape (discussed supra for claim 16) and fixing the tapered edge portion to an inner wall of the tubular structure by applying fibrin glue (discussed supra for claim 16) in such a manner that the tapered edge portion of the sheet of biological tissue is positioned on an inner side (discussed supra for claim 16) and then performing decellularization on the sheet of biological tissue (discussed supra for claim 23),
wherein the sheet includes on at least one side the tapered edge portion thinning down in a thickness direction towards an end thereof (discussed supra for claim 16),
wherein a thickness of the sheet is 173 to 660 micrometers (discussed supra for claim 18),
wherein the at least one side of the sheet is in a length direction (discussed supra for claim 19),
wherein an angle of the tapered edge is in a range of 27o to 52o (discussed supra for claim 17), and
wherein a length of the at least one side in the length direction of the sheet is 10 to 400 millimeters and a length of one side in a width direction of the sheet is 1.5 to 200 millimeters (discussed supra for claim 20).
Regarding Claim 29, the tapered edge has a slanting shape on one face of the sheet (discussed supra for claim 21).
Regarding Claim 30, a tissue material of the biological tissue is an animal blood vessel (discussed supra for claim 22).
Regarding Claim 31, at least a part of a wall portion of the tubular structure has a two-layer structure (discussed supra for claim 24).
Regarding Claim 32, an inner circumference of the tubular structure is 6.0 millimeters or greater and 40 millimeters or less.
The combination of Hinds, Xie, Giungo, and Woodroof discloses the invention substantially as claimed but fails to teach an inner circumference of the tubular structure is 6.0 millimeters or greater and 40 millimeters or less.
Woodroof teaches a vascular implant made of a sheet of material made into a tubular body (e.g. abstract, Figure 1-2, 8-9) where the inner circumference is 6.0 millimeters or greater and 40 millimeters or less (e.g. column 2, lines 51-63). The inner diameter is 4 mm. Thus, the circumference is 2*pi*r = 2*pi*2 = 12.56 mm.
Woodroof and the combination of Hinds, Xie, Giungo, and Woodroof are concerned with the same field of endeavor as the claimed invention, namely implants made from planar sheets of material rolled into tubular structures.
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 Hinds, Xie, Giungo, and Woodroof such that the inner circumference is 6.0 millimeters or greater and 40 millimeters or less as taught by Woodroof 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 33, a pressure resistance of 400 mmHg or higher (discussed supra for claim 27).
Regarding Claim 35, the combination of Hinds, Xie, Giungo, and Woodroof teaches an artificial blood vessel comprising the tubular structure of claim 28 (discussed supra for claim 34).
Claim 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hinds, et al (Hinds) (US 2006/0257447 A1) in view of Xie, et al (Xie) (US 2003/0181968 A1) as discussed supra and further in view of Woodroof (US 4,502,159).
Regarding Claim 26, the combination of Hinds and Xie discloses the invention substantially as claimed but fails to teach an inner circumference of the tubular structure is 6.0 millimeters or greater and 40 millimeters or less.
Woodroof teaches a vascular implant made of a sheet of material made into a tubular body (e.g. abstract, Figure 1-2, 8-9) where the inner circumference is 6.0 millimeters or greater and 40 millimeters or less (e.g. column 2, lines 51-63). The inner diameter is 4 mm. Thus, the circumference is 2*pi*r = 2*pi*2 = 12.56 mm.
Woodroof and the combination of Hinds and Xie are concerned with the same field of endeavor as the claimed invention, namely implants made from planar sheets of material rolled into tubular structures.
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 Hinds and Xie such that the inner circumference is 6.0 millimeters or greater and 40 millimeters or less as taught by Woodroof 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).
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, Jerrah Edwards can be reached on (408) 918-7557. 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 1/9/2026