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 .
Response to Arguments
Applicant's arguments filed 09/22/2025 have been fully considered but they are not persuasive.
Regarding Armstrong, applicant argues that the lattice is embedded in the endoprosthesis (see Fig. 2a) and thus does not disclose fibers that extend away from a surface. However, Fig. 2a shows the lattice on the outside surface of the stent rather than embedded so it is unclear what applicant is referring to. Applicant states that Armstrong does not have all the features of the amended claim because if the lattice is the claimed fiber, then there is no graft structure. However, [0055] states that the prosthesis can be a stent, a graft or a stent-graft and [0059] states the lattice covering can be attached to a stent, graft or stent-graft.
Regarding the argument that Armstrong teaches away from the fiber being thrombogenic, examiner respectfully disagrees. While [0090] recites that the lattice can be anti-thrombotic, this is merely one option in a laundry list of options and would be specific to the intended use of the device. Armstrong also discloses treating aneurysms [0057-0060] where is it is old and well known that it is desirable to induce thrombosis. ‘
Regarding Angel, applicant argues that the there is no graft disclosed as part of the body. However, page 10 explicitly states that the body is a stent sutured to a tubular sheath, typically made of polyester. Thus, Angel discloses a stent attached to a graft.
Arguments to Soletti as it does not apply to its use as a teaching reference. Arguments to Bar are moot as it is no longer being relied on.
By the amendment filed 09/22/2025 all previous claim objections and 112(b) rejections are withdrawn. Double Patenting rejection over 17761748 has been withdrawn in light of the abandonment of ‘748. As requested, drawings have been indicated as accepted and foreign priority has been acknowledged.
Claim Objections
Claims 26 and 32 are objected to because of the following informalities:
Claim 26 recites the “the at least on fiber is a thrombogenic fiber” however the feature of a thrombogenic fiber is already recited in claim 17. Thus, this appears to be redundant and unnecessary to further limiting the claim.
Claim 32 is objected to because of the following informalities: Claim 32 recites “the endoprosthesis” however claim 30 recites a graft. It is understood that the endoprosthesis refers back to the graft however for consistency, applicant is requested to correct the terminology.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 33 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 33 recites “the fiber is a thrombogenic fiber” which is already recited in claim 30, from which claim 33 depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 17-19, 21-24, 26, 29, 30, 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong et. al. (US 2017/0065400) and Cully (2007/0198077), incorporated by reference, in view of Angel (WO 2013/186214)
Armstrong discloses an endoprosthesis comprising a graft with a graft surface [0055] , further comprising at least one fiber arranged on the graft surface (lattice 200 covers the stent-graft [0059] and is formed from a fiber [0072] and having serpentine fibrils (Fig. 14), [0111]), wherein the graft surface is adapted to attach the at least one fiber (Note Cully, which is incorporated by reference [0055], disclose the graft is located on the outer surface [0012] as such the graft surface is considered adapted to attach the at least one fiber/covering), further comprising a stent on which the graft is carried ([0055] discloses the prosthesis has a stent and a graft),
Armstrong does not disclose wherein the graft is attached to the stent by one or more attachment sutures, and wherein the at least one fiber is distinct from the one or more attachment sutures,
However, Angel teaches a stent graft (last paragraph page 10) where the graft (tubular sheath made of polyester) is attached to the stent by one or more attachment sutures.
Using sutures to attach a graft to a stent is one of a finite number of options known in the art. Thus, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date would have found it "obvious to try" using sutures to attach the graft to the stent such that the attachment sutures are distinct from the fiber, since there are only a finite number of identified solutions that would have a reasonable expectation of success of securing the graft to the stent. A person of ordinary skill has good reason to pursue the known options within his or her technical grasp if it yields predictable results. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Armstrong does not disclose wherein the at least one fiber is a thrombogenic fiber and extends away from the graft surface. However, Armstrong does disclose using the stent graft for isolating sections of host vessel lumen, such as aneurysms [0055].
Angel discloses a stent graft also used for treating an aneurysm where it is desirable to create a thrombosis effect outside the endoprosthesis (page 11 lines 1-5) by using thrombogenic fibers (3) fixed to the outside of the device (page 11, lines 18-20).
Thus, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to form the at least one fiber in Armstrong to be thrombogenic as taught by Angel to assist in creating a thrombosis effect when treating an aneurysm.
Armstrong further discloses:
Claim 18: wherein at least one of the graft or fiber has a surface that is adapted such that the fiber is retained by friction on the graft surface (friction fit [0095]).
Claim 19. wherein the graft surface is at least partially coated with an adhesive material that is adapted to provide adhesion to the surface of the fiber (adhered through suitable adhesive [0095])
Claim 21: wherein the adhesive material is adapted such that it is activatable by at least one of heat (thermoset adhesive [0095]).
Claim 22: wherein the adhesive material is coated on discrete positions of the graft surface. (coating in discontinuous faction [0097]).
Claim 23: wherein the fiber comprises a material which is, in a molten or partially molten state, at least partially miscible with a material that at least one of the graft and the graft surface comprise (cover/lattice is coated with molten FEP [00097]).
Claim 24: wherein the graft comprises a mechanical structure that is adapted to be attached to a fiber (discrete mechanical attachment points - clips [0095]).
Claim 26: the at least one fiber is a thrombogenic fiber having a free portion configured to extend at least partly away from the surface of the graft (the outer surface of the lattice is a free surface extending away from the surface of the graft).
Claim 29: wherein the graft surface is configured to keep the fiber attached to the graft after implantation (lattice cover is attached to and delivered with stent graft [0021]).
Claim 30: A method of attaching a fiber to a surface, wherein a graft comprising a graft surface is provided, and a fiber is attached to the surface, wherein the attachment of the fiber is performed by mechanical attachment [0095] and the fiber is thrombogenic fiber (taught by Angel as noted above) and extends away from the graft surface (fiber lattice is on outer surface of graft and therefore extends away from the graft surface).
Claim 32: wherein the fiber is attached to the surface in a separate step after manufacturing the endoprosthesis [0135-0138].
Claim 33: the fiber is thrombogenic fiber (taught by Angel as noted above).
Claim 34: wherein the endoprosthesis is detachably mounted to a holder of the catheter ([0103-0104 and see references incorporated by reference U.S. Pat. Nos. 6,139,572; 6,352,561 and 7,198,636).
Claim 35: wherein the at least one fiber is attached to the graft surface by one of welding and gluing (attached through use of adhesive [0095]).
Further, the claimed phrase “by welding” or “by gluing” is being treated as a Product by Process limitation that is the attachment of the fiber to the stent graft is formed by gluing or welding. As set forth in the MPEP 2113, "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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (See MPEP § 2113). Examiner will thus evaluate the product claims without giving much weight to the method of its manufacture.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong et. al. (US 2017/0065400) and Cully (2007/0198077), incorporated by reference, in view of Angel (WO 2013/186214) as applied to claim 17 and further in view of Soletti et. al. (US 2014/0288632).
Modified Armstrong discloses the invention as stated above including using adhesive to material to adhere the at least on fiber [0095] but does not disclose the adhesive is a bioactive material.
Soletti discloses n endoprosthesis (see Fig. 1) comprising a graft with a graft surface (340 [0051]), further comprising at least one fiber arranged on the graft surface (320), wherein the graft surface is attach to the fiber by adhesive (treated to bond or adhere to the fiber matrix [0020]), wherein the adhesive material is bioactive or comprises a bioactive material (adhesive is bioerodable [0045] or can deactivate at time of implantation [0048]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to incorporate the use of bioactive material and allow for the degradation of the attached fiber layer over time. This would be advantageous for example if there was a desire to remove the stent graft or if the fiber layer was no longer effective after a certain amount of time.
Claim(s) 17 24-26, 29-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baxter (US 20190083226) in view of Angel (WO 2013/186214).
Baxter discloses: An endoprosthesis (20) comprising a graft with a graft surface (22), further comprising at least one fiber (30) arranged on the graft surface (Fig. 1), wherein the graft surface is adapted to attach the at least one fiber [0008], further comprising a stent (21) on which the graft is carried, and further wherein the at least one fiber is a thrombogenic fiber ([0008] the streamers promote coagulation of blood) and extends away from the graft surface (Fig. 1)
Baxter does not disclose wherein the graft is attached to the stent by one or more attachment sutures, and wherein the at least one fiber is distinct from the one or more attachment sutures.
However, Angel teaches a stent graft where the graft (tubular sheath made of polyester) is attached to the stent by one or more attachment sutures (last paragraph page 10).
Using sutures to attach a graft to a stent is one of a finite number of options known in the art. Thus, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date would have found it "obvious to try" using sutures to attach the graft to the stent such that the attachment sutures are distinct from the fiber, since there are only a finite number of identified solutions that would have a reasonable expectation of success of securing the graft to the stent. A person of ordinary skill has good reason to pursue the known options within his or her technical grasp if it yields predictable results. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Claim 24: wherein the graft comprises a mechanical structure (40) that is adapted to be attached to the at least one fiber [0008].
Claim 25: wherein the graft comprises a mechanical structure selected from the group consisting of a hole, a loop, and a rivet ([0008] discloses that a suture is used to the fabric tube via sutures which would necessarily mean the graft had holes for receiving the sutures).
Claim 26: wherein the at least one fiber is a thrombogenic fiber having a free portion configured to extend at least partly away from the surface of the graft ([0008], Fig. 1).
Claim 29: wherein the graft surface is configured to keep the at least one fiber attached to the graft after implantation (Fig. 1).
Claim 30: method of attaching a fiber to a graft surface, wherein a graft (22) is provided which comprises the graft surface, and the fiber (32) is attached to the graft surface by at least one from the group consisting of welding, gluing, heating by exposure to ultra- sound waves, heating by exposure to electromagnetic radiation, and mechanical attachment ([0008] sutures),
Claim 31: wherein after attachment, the at least one fiber is a thrombogenic fiber and extends away from the graft surface (Fig. 1).
Claim 32: wherein the fiber is attached to the graft surface in a separate step after manufacturing the endoprosthesis ([0008] sutured to the stent or graft implies after the endoprosthesis is manufactured).
Claim 33: the fiber is a thrombogenic fiber [0008]/
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 ELIZABETH HOUSTON whose telephone number is (571)272-7134. The examiner can normally be reached generally M-F 8:00-4:30.
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/ELIZABETH HOUSTON/ Supervisory Patent Examiner, Art Unit 3771
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