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 08/05/2026 have been fully considered but they are not persuasive.
Regarding the disclosure to vasospasm in [0003] of Sabaria, Sabaria is disclosing that generic metallic stents “can lead to biological problems including vasospasm,” in which the device of Sabaria is disclosed to rectify the problems of the generic metallic stent that causes vasospasm. As Vasospasms are disclosed as a problem by generic stents known in the art, and as Sabaria is disclosed as teaching a novel method for manufacturing a stent to solve problems known in the art, Sabaria is still relied upon to teach a treatment of the problems disclosed in the Background/Summary section of Sabaria. As per arguments on page 6 of the applicant’s remarks dated 08/05/2026, it is stated that nothing in Sabaria or Ryan suggests a coating that might treat vasospasm. Examiner notes that a “coating” for an explicit treatment of Vasospasm is not present in the amended claimset. As Sabaria states
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) 15, 20-21, 25, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabaria (US Pub No.: 2009/0133817) in view of Ryan (US Pub No.: 2021/0154372).
Regarding claim 15, Sabaria discloses a method for the treatment of a vasospasm (in [0003] of Sabaria), comprising the steps of: delivering a metal stent (metal stents in the abstract, delivery via a balloon catheter in [0083] and [0085]-[0086]), using an insertion aid fixed to the stent (being the catheter with an expandable balloon to place the stent in [0085]), to a blood vessel of the body of a patient (deployment of a blood vessel in [0087]) to treat vasospasm of the blood vessel (as Vasospasms are disclosed in [0003] as a problem in generic metallic stents in [0003]-[0004], Sabaria is seen as teaching a method of manufacturing a stent that avoids the problems of generic metallic stents in [0003]), and detaching the metal stent from the insertion aid to permanently place the stent in the blood vessel (as the stent is for use in a patient body in the abstract, a detaching from a catheter after introduction into the body in [0093] is required); wherein the stent is a metal stent coated with a coating comprising a functional layer (coatings in [0040], drugs for coating in [0032])
Sabaria does not teach that the stent is with said functional layer being formed by an oligo- or polymerization of monosaccharides functionalized with polymerizable groups.
Instead, Ryan (US Pub No.: 2021/0154372) teaches that said functional layer (being the coating in [0022] that comprises a therapeutic agent and a surfactant) and/or being formed by an oligo- or polymerization of monosaccharides functionalized with polymerizable groups (being glucose disclosed in [0211]. Sugar alcohols as a surfactant in [0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the coating with a surfactant as presented in Ryan into Sabaria as surfactant coatings are known in the art as being used to minimize an inflammatory response for an implanted device, with the surfactants of Ryan disclosed as preventing a loss of a coated drug on a stent as per [0134].
Regarding claim 20, Sabaria in view of Ryan teach the method of claim 15, wherein Sabaria discloses the monosaccharide of the functional layer is functionalized in a form bonded to the metal stent via at least one reactive multiple bond (polytrimethylenecarbonate in [0031] of Sabaria has a double bond).
Regarding claim 21, Sabaria in view of Ryan teach the method of claim 15, wherein the reactive double bond is a constituent of a (meth)acrylic group (polytrimethylenecarbonate in [0031] of Sabaria).
Regarding claim 25, Sabaria in view of Ryan teach the method of claim 20, wherein the reactive multiple bond is a double bond (polytrimethylenecarbonate in [0031] of Sabaria has a double bond).
Regarding claim 27, Sabaria teaches a method for the treatment of a vasospasm (in [0003]) comprising the steps of: delivering a metal stent (metal stents in the abstract, delivery via a balloon catheter in [0083] and [0085]-[0086]), using an insertion aid fixed to the stent (being the catheter with an expandable balloon to place the stent in [0085]), to a blood vessel of the body of a patient (deployment of a blood vessel in [0087]) to treat vasospasm of the blood vessel (as Vasospasms are disclosed in [0003] as a problem in generic metallic stents in [0003]-[0004], Sabaria is seen as teaching a method of manufacturing a stent that avoids the problems of generic metallic stents in [0003]) and detaching the metal stent from the insertion aid to permanently place the stent in the blood vessel (as the stent is for use in a patient body in the abstract, a detaching from a catheter after introduction into the body in [0093] is required); wherein the stent is a metal stent coated with a coating comprising a functional layer (coatings in [0040], drugs for coating in [0032]).
Sabaria does not teach that the coating’s functional layer is comprising at least one sugar alcohol.
Instead, Ryan (US Pub No.: 2021/0154372) teaches that said functional layer (being the coating in [0022] that comprises a therapeutic agent and a surfactant) comprising at least one sugar alcohol (sugar alcohols as a surfactant in [0041]) and/or being formed by an oligo- or polymerization of monosaccharides functionalized with polymerizable groups (being glucose disclosed in [0211]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the coating with a surfactant as presented in Ryan into Sabaria as surfactant coatings are known in the art as being used to minimize an inflammatory response for an implanted device, with the surfactants of Ryan disclosed as preventing a loss of a coated drug on a stent as per [0134].
Claim(s) 22 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabaria (US Pub No.: 2009/0133817) in view of Ryan (US Pub No.: 2021/0154372) in further view of Liebig (US Pub No.: 2019/0110912).
Regarding claim 22, Sabaria in view of Ryan teach a device according to Claim 15. However, Sabaria in view of Ryan does not teach wherein the metal is provided with a gold coating under the functional layer.
Instead, Liebig (US Pub No.: 2019/0110912) teaches wherein the metal is provided with a gold coating under the functional layer (gold coating in [0038]. Said coating will be under the functional layer of Sabaria and Ryan to not impede the function of the functional layer). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the physical properties of Liebig into the device of Sabaria for the purpose of providing a radiopaque material throughout the entirety of a stent structure to help visualize the deice in the body, as per [0038].
Regarding claim 28, Sabaria in view of Ryan teach a device according to Claim 27. However, Sabaria in view of Ryan does not teach wherein the metal is provided with a gold coating under the functional layer.
Instead, Liebig teaches wherein the metal is provided with a gold coating under the functional layer (gold coating in [0038]. Said coating will be under the functional layer of Sabaria and Ryan to not impede the function of the functional layer). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the physical properties of Liebig into the device of Sabaria for the purpose of providing a radiopaque material throughout the entirety of a stent structure to help visualize the deice in the body, as per [0038].
Claim(s) 23-24, 26, 29-32 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabaria (US Pub No.: 2009/0133817) in view of Ryan (US Pub No.: 2021/0154372) in further view of Hodgkinson (US Pub No.: 2013/0060348).
Regarding claim 23, Sabaria in view of Ryan teach a device according to Claim 15. However, Sabaria in view of Ryan does not teach the coating further comprises a carrier layer located on the stent structure with an adhesion promoter, and the functional layer is bonded to the carrier layer.
Instead, Hodgkinson (US Pub No.: 2013/0060348) teaches wherein the coating comprises a carrier layer located on the stent structure with an adhesion promoter (being disclosed as an adhesion promoting layer in the abstract and [0008]. Use for surgical implant also in the abstract), and the functional layer is bonded to the carrier layer (being the hydrogel layer in [0029]. It stands to reason that the functional layer of Sabaria can also be bonded to the adhesion layer of Hodgkinson as the hydrogel layer encompasses a medical drug in [0031], making it equivalent to the functional layers of Sabaria). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a silane based adhesion layer for the purpose of providing an adhesion promoting layer (in the abstract) that enable an attachment of the device in the body while preventing scarring (as per the definition of adhesion, facilitation of attachment of implants in [0003]).
Regarding claim 24, Sabaria in view of Ryan teach a device according to Claim 23. Sabaria does not teach wherein the adhesion promoter is a silicon compound.
Instead, Hodgkinson (US Pub No.: 2013/0060348) teaches wherein the adhesion promoter is a silicon compound. (silane based adhesion promoting layer for an implant in the abstract and [0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a silane based adhesion layer for the purpose of providing an adhesion promoting layer (in the abstract) that enable an attachment of the device in the body while preventing scarring (as per the definition of adhesion, facilitation of attachment of implants in [0003]).
Regarding claim 26, Sabaria in view of Ryan and Hodgkinson teach a device according to Claim 24. However, Sabaria in view of Ryan does not teach wherein the silicon compound is a silane compound.
Instead, Hodgkinson teaches wherein the silicon compound is a silane compound (silane based adhesion promoting layer for an implant in the abstract and [0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a silane based adhesion layer for the purpose of providing an adhesion promoting layer (in the abstract) that enable an attachment of the device in the body while preventing scarring (as per the definition of adhesion, facilitation of attachment of implants in [0003]).
Regarding claim 29, Sabaria in view of Ryan and Hodgkinson teach the method of claim 27. However, Sabaria in view of Ryan does not teach wherein the coating further comprises a carrier layer located on the stent structure with an adhesion promoter, and the functional layer is bonded to the carrier layer.
Instead, Hodgkinson (US Pub No.: 2013/0060348) teaches wherein the coating further comprises a carrier layer located on the stent structure with an adhesion promoter (being disclosed as an adhesion promoting layer in the abstract and [0008]. Use for surgical implant also in the abstract), and the functional layer is bonded to the carrier layer (being the hydrogel layer in [0029]. It stands to reason that the functional layer of Sabaria can also be bonded to the adhesion layer of Hodgkinson as the hydrogel layer encompasses a medical drug in [0031], making it equivalent to the functional layers of Sabaria). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a silane based adhesion layer for the purpose of providing an adhesion promoting layer (in the abstract) that enable an attachment of the device in the body while preventing scarring (as per the definition of adhesion, facilitation of attachment of implants in [0003]).
Regarding claim 30, Sabaria in view of Ryan and Hodgkinson teach the method of claim 29. Sabaria in view of Ryan and does not teach wherein the adhesion promoter is a silicon compound, in particular a silane compound, or a polyolefin.
Instead, Hodgkinson (US Pub No.: 2013/0060348) teaches wherein the adhesion promoter is a silicon compound, in particular a silane compound, or a polyolefin (silane based adhesion promoting layer for an implant in the abstract and [0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a silane based adhesion layer for the purpose of providing an adhesion promoting layer (in the abstract) that enable an attachment of the device in the body while preventing scarring (as per the definition of adhesion, facilitation of attachment of implants in [0003]).
Regarding claim 31, Sabaria in view of Ryan and Hodgkinson teach the method of claim 30. Sabaria in view of Ryan and does not teach wherein the silicon compound is a silane compound.
Instead, Hodgkinson teaches wherein the silicon compound is a silane compound (silane based adhesion promoting layer for an implant in the abstract and [0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a silane based adhesion layer for the purpose of providing an adhesion promoting layer (in the abstract) that enable an attachment of the device in the body while preventing scarring (as per the definition of adhesion, facilitation of attachment of implants in [0003]).
Regarding claim 32, Sabaria in view of Ryan and Hodgkinson teach the method of claim 24. Sabaria in view of Ryan and does not teach wherein the silicon compound comprises a silane compound or a polyolefin.
Instead, Hodgkinson (US Pub No.: 2013/0060348) wherein the silicon compound comprises a silane compound or a polyolefin (silane based adhesion promoting layer for an implant in the abstract and [0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a silane based adhesion layer for the purpose of providing an adhesion promoting layer (in the abstract) that enable an attachment of the device in the body while preventing scarring (as per the definition of adhesion, facilitation of attachment of implants in [0003]).
Regarding claim 34, Sabaria in view of Ryan and Hodgkinson teach the method of claim 30. Sabaria in view of Ryan does not teach wherein the silicon compound comprises a silane compound or a polyolefin.
Instead, Hodgkinson (US Pub No.: 2013/0060348) wherein the silicon compound comprises a silane compound or a polyolefin (silane based adhesion promoting layer for an implant in the abstract and [0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a silane based adhesion layer for the purpose of providing an adhesion promoting layer (in the abstract) that enable an attachment of the device in the body while preventing scarring (as per the definition of adhesion, facilitation of attachment of implants in [0003]).
Claim(s) 33 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabaria (US Pub No.: 2009/0133817) in view of Ryan (US Pub No.: 2021/0154372) in further view of Burgmeier (US Pub No.: 2023/0091740).
Regarding claim 33, Sabaria in view of Ryan and Hodgkinson teach method of claim 24. Sabaria in view of Ryan and Hodgkinson does not teach wherein the silicon compound comprises polyolefin.
Instead, Burgmeier (US Pub No.: 2023/0091740) teaches wherein the silicon compound comprises polyolefin (in [0078]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a polyolefin as presented in Burgmeier into Sabaria for the purpose of providing an elastomer (in [0078]) which provide elastic characteristics that allow for expansion and contraction of the prosthesis (in [0078]), with Polyolefin being known in the art as having high durability and chemical resistance while being flexible.
Regarding claim 35, Sabaria in view of Ryan and Hodgkinson teach the method of claim 30. Sabaria in view of Ryan and Hodgkinson does not teach wherein the silicon compound comprises polyolefin.
Instead, Burgmeier (US Pub No.: 2023/0091740) teaches wherein the silicon compound comprises polyolefin (in [0078]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a polyolefin as presented in Burgmeier into Sabaria for the purpose of providing an elastomer (in [0078]) which provide elastic characteristics that allow for expansion and contraction of the prosthesis (in [0078]), with Polyolefin being known in the art as having high durability and chemical resistance while being flexible.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. (Mertens US Pub No.: 2022/0176084) disclosed for a medical stent in the abstract with a coating layer in [0030]. Fulkerson (US Patent No.: 9,220,522) teaches a stent with self-expanding details in column 2 lines 32-44.
THIS ACTION IS MADE FINAL. 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.
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/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
