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 .
Response to Arguments
This Office action is in response to the applicant’s communication filed on 7/9/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s arguments, see page 6, with respect to Applicant’s claim amendments made in view of the previous claim objections have been fully considered and are persuasive. The previous claim objections have been withdrawn.
Applicant’s arguments, see pages 6-9, with respect to the deficiencies of Brodbeck (i.e., not arched outward) in view of the present amendments to claims 1 have been fully considered and are persuasive. Therefore, the previous rejection of claim 1 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under Brodbeck in view of Amarant et al. (US 2006/0004436), as set forth below.
Applicant's arguments, see pages 9-10, alleging that Dickinson teaches the porosity of the stent and not the covering graft material have been fully considered but they are not persuasive. It is the Examiner’s position that Applicant’s arguments comprise an over narrowly interpretation of the teachings of Dickinson. Dickinson expressly teaches porosity ranges for any of stents, stent-grafts or subportions thereof (emphasis added; see [0178]). Subportions of a stent-graft are interpreted as including the graft/covering membrane attached to the stent structure which together comprise the overall stent-graft. For at least these reason, Applicant’s arguments are not persuasive.
Applicant’s arguments, see pages 10-11, with respect to the deficiencies of the prior art of record in view of new independent claim 22 have been fully considered and are persuasive. New claim 22 has been allowed herein.
Claim Rejections - 35 USC § 103
Claim(s) 1-2, 5-7, 9 and 11-19 are rejected under 35 U.S.C. 103 as being unpatentable over Brodbeck et al. (US 2007/0179599) in view of Amarant et al. (US 2006/0004436).
Brodbeck discloses (see Figs. 9 and 10A) a vascular protective device comprising the following claim limitations:
(claim 1) A stent (20, Fig. 9) for a blood vessel, comprising a covering membrane (50, Fig. 9) and anchoring members (30, Fig. 9) connected to the covering membrane (50); and at least one support member (40, Fig. 9) connected between adjacent two of the anchoring members (30) respectively located at different ends of the stent (20) (as shown in Fig. 9); wherein the anchoring members (30) are disposed at both ends of the stent (20) along an axial direction of the stent (20) and are configured to (i.e., capable of) secure the stent (20) within the blood vessel ([0002]-[0006]; [0009]-[0010]; [0058]); the covering membrane (50) is fixed through the anchoring members (30) and is configured to (i.e., capable of) pocket a diseased area of the blood vessel (as shown in Figs. 9-10C and exemplary Figs. 3A-4; see Abstract and claim 1; [0002]-[0006]; [0009]-[0010]), wherein an outer surface of the covering membrane (50) comprises a cell-binding substance (see claims 8-9; [0022]-[0023]; [0026]; exterior adhesive coating expressly disclosed); and the support member (40) is located on an inner side of the covering membrane (50) (as expressly shown in Fig. 10A; [0065]);
(claim 2) wherein the covering membrane (50) is made of a bioabsorbable material selected from the group consisting of a polyester, a polycarbonate, and a composite thereof ([0013]; [0024]; film composed of polyester and or polycarbonates expressly disclosed);
(claim 5) wherein a thickness of the covering membrane is less than or equal to 100 μm ([0019]; polymer film layer thicknesses of less than 100 μm expressly disclosed (e.g., 0.02-75 μm and/or 1-30 μm));
(claim 6) wherein two or more of the anchoring members (30) are located at a same end of the stent (20) and distributed along the axial direction of the stent (20) (as shown in annotated Fig. 9 below, both ends of the stent comprises two separate circumferential rings);
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(claim 7) wherein adjacent two of the anchoring members (30) located at the same end of the stent (20) are spaced apart and connected through a connecting member (as shown in annotated Fig. 9 above, the two separate circumferential rings at each end are connected by serpentine connecting members);
(claim 9) wherein the support member (40) is further fixed to a middle section of the covering membrane (50) (as shown in Fig. 9; [0017]; using adhesive, melted bond, and the like to attach the covering membrane to and along the support members is expressly disclosed);
(claim 12) further comprising mounting members (i.e., micro-structures formed on the anchoring members 30) (see claim 8; [0014]), wherein the anchoring members (30) located at the ends of the stent (20) are spaced apart from the covering membrane (50) and connected to the covering membrane (50) through the mounting members ([0014]; micro-structures expressly disposed on the surface of the anchoring members 30 to bridge the gap and connect/secure the anchoring members 30 to the covering membrane 50);
(claim 13) wherein the anchoring members (30) are formed by a straight, wavy, or bent anchoring bar connected head to tail (as shown in annotated Fig. 9 above; anchoring members are wavy/undulating circumferential rings);
(claim 14) wherein widths of the anchoring members (30) range from 50 μm to 5000 μm ([0030]; the width/diameter of embodiments of the anchoring members 30 expressly disclosed to include 1 mm (equal to 1000 μm) (widths/diameters of 1-13 mm disclosed));
(claim 15) wherein a region of the anchoring members (30) adjacent to an inner wall of the blood vessel is provided with a groove ([0014]; [0022]; groove surface structures expressly disclosed);
(claim 16) wherein the cell-binding substance is selected from the group consisting of a protein, a physiologically active substance, a compound, and any combination thereof ([0013]-[0014]; [0018]; [0026]; proteins active substances and compounds are each expressly disclosed);
(claim 17) wherein the protein is selected from the group consisting of a disease marker, a cell growth factor, a cell adhesion factor, an antibody, and any combination thereof ([0018]; [0026]; proteins including cell growth factors, antibodies and/or cell adhesion factors are expressly disclosed);
(claim 18) wherein the physiologically active substance is selected from the group consisting of carbohydrate, serotonin, norepinephrine, epinephrine, 3- (3,4-dichlorophenyl)-1,1-dimethylurea, atrazine, linuron, simazine, and any combination thereof ([0014]; [0018]; active substances including carbohydrates, serotonin, and the like are expressly disclosed); and
(claim 19) wherein the compound is selected from the group consisting of a peptide, an amino acid, a primary amine, a primary diamine, and any combination thereof ([0013]; [0018]; compounds including peptides, amino acids, and the like are expressly disclosed).
Brodbeck, as applied above, discloses a vascular protective device comprising all the limitations of the claim except for a length of a straight support member along the axial direction of the stent being 5% to 20% greater than a distance between the adjacent two of the anchoring members respectively located at different ends of the stent such that the covering membrane is arched outward.
However, Amarant teaches (see Figs. 1B and 7A) a similar stent-graft (10) comprising a length of a straight support member (20, Fig. 1B) along the axial direction of the stent being greater than a distance between the adjacent two of the anchoring members respectively located at different ends of the stent such that the covering membrane is arched outward (as shown in Fig. 1B; straight support members depicted to arch outward) in order to beneficially provide improved clinical results in the vessel passageway, not interfere with the fluid flow through the passageway, eventually be covered with endothelial cell growth that further minimizes fluid flow interference, and provide improved radial force and decreases trauma to the interior surface of the vessel while essentially stretching the vessel wall to the point of making a seal all the way around the periphery of the stent ([0062]; [0064]; [0077]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Brodbeck to have a length of the support member along the axial direction of the stent being greater than a distance between the adjacent two of the anchoring members respectively located at different ends of the stent such that the covering membrane is arched outward in order to beneficially provide improved clinical results in the vessel passageway, not interfere with the fluid flow through the passageway, eventually be covered with endothelial cell growth that further minimizes fluid flow interference, and provide improved radial force and decreases trauma to the interior surface of the vessel while essentially stretching the vessel wall to the point of making a seal all the way around the periphery of the stent, as taught by Amarant.
Regarding the claimed length percentages of claim 11, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the device of Brodbeck in view of Amarant wherein the length of the support member along the axial direction of the stent is 5% to 20% greater than the distance between the adjacent two of the anchoring members respectively located at different ends of the stent, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Brodbeck in view of Amarant as applied to claim 1 above, and further in view of Dickinson et al. (AU 2019204740).
Brodbeck, as applied above, discloses a vascular protective device comprising all the limitations of the claim except for wherein a porosity of the covering membrane ranges from 50% to 100% and the porosity at both ends of the covering membrane, along the axial direction of the stent, is greater than that in a middle section of the covering membrane.
However, Dickinson teaches a similar vascular protective device comprising a porosity of the covering membrane ranges from 50% to 100% ([0178]; intermediate portion porosity of 50%-90% expressly disclosed for either stent-grafts or subportions thereof) and the porosity at both ends of the covering membrane, along the axial direction of the stent, is greater than that in a middle section of the covering membrane ([0178]; greater porosity at the ends as compared to the middle/intermediate portion expressly disclosed) in order to beneficially increase fluid flow through the device while allowing the end portions to have increased flexibility and wall apposition ([0178]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Brodbeck to have a porosity of the covering membrane ranges from 50% to 100% and the porosity at both ends of the covering membrane, along the axial direction of the stent, is greater than that in a middle section of the covering membrane in order to beneficially increase fluid flow through the device while allowing the end portions to have increased flexibility and wall apposition, as taught by Dickinson. Additionally and/or in the alternative, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the membrane having the claimed porosity, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Brodbeck in view of Amarant as applied to claim 12 above, and further in view of Kang et al. (US 2017/0151051).
Brodbeck, as applied above, discloses a vascular protective device comprising all the limitations of the claim except for wherein the mounting members are a plurality of filaments extending out from the ends of the covering membrane.
However, Kang teaches a similar vascular protective device comprising mounting members in the form of a plurality of filaments extending out from the ends of the covering membrane ([0006]; “covering a stent with the film, and then fixing both ends of the film to the stent using a suture”). Accordingly, Kang teaches that it is known that attaching a covering to a stent via an adhesive and that attaching a covering to a stent via suture threads are elements that are functional equivalents for providing an attachment mechanism to secure and connect a covering membrane to a stent structure. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the suture thread attachments taught by Kang for the adhesive attachment of Brodbeck because both elements were known equivalents for providing an attachment mechanism to secure and connect a covering membrane to a stent structure within the vascular protective device art. The substitution would have resulted in the predictable results of providing an attachment mechanism to secure and connect a covering membrane to a stent structure in the device of Brodbeck.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Brodbeck et al. (US 2007/0179599) in view of Dickinson et al. (AU 2019204740).
Brodbeck discloses (see Figs. 9 and 10A) a vascular protective device comprising the following claim limitations:
(claim 21) A stent (20, Fig. 9) for a blood vessel, comprising a covering membrane (50, Fig. 9) and anchoring members (30, Fig. 9) connected to the covering membrane (50); the anchoring members (30) are disposed at both ends of the stent (20) along an axial direction of the stent (20) and are configured to (i.e., capable of) secure the stent (20) within the blood vessel ([0002]-[0006]; [0009]-[0010]; [0058]); the covering membrane (50) is fixed through the anchoring members (30) and is configured to (i.e., capable of) pocket a diseased area of the blood vessel (as shown in Figs. 9-10C and exemplary Figs. 3A-4; see Abstract and claim 1; [0002]-[0006]; [0009]-[0010]), wherein an outer surface of the covering membrane (50) comprises a cell-binding substance (see claims 8-9; [0022]-[0023]; [0026]; exterior adhesive coating expressly disclosed).
Brodbeck, as applied above, discloses a vascular protective device comprising all the limitations of the claim except for wherein a porosity of the covering membrane ranges from 50% to 100% and the porosity at both ends of the covering membrane, along the axial direction of the stent, is greater than that in a middle section of the covering membrane.
However, Dickinson teaches a similar vascular protective device comprising a porosity of the covering membrane ranges from 50% to 100% ([0178]; intermediate portion porosity of 50%-90% expressly disclosed for either stent-grafts or subportions thereof) and the porosity at both ends of the covering membrane, along the axial direction of the stent, is greater than that in a middle section of the covering membrane ([0178]; greater porosity at the ends as compared to the middle/intermediate portion expressly disclosed) in order to beneficially increase fluid flow through the device while allowing the end portions to have increased flexibility and wall apposition ([0178]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Brodbeck to have a porosity of the covering membrane ranges from 50% to 100% and the porosity at both ends of the covering membrane, along the axial direction of the stent, is greater than that in a middle section of the covering membrane in order to beneficially increase fluid flow through the device while allowing the end portions to have increased flexibility and wall apposition, as taught by Dickinson. Additionally and/or in the alternative, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the membrane having the claimed porosity, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Allowable Subject Matter
Claim 22 is allowed.
The following is an examiner’s statement of reasons for allowance: the art of record does not teach or render obvious a stent for a blood vessel as claimed that includes, in combination with the claim(s) as a whole, the anchoring members located at the ends of the stent are spaced apart from the covering membrane and connected to the covering membrane through the mounting members, the mounting members each comprises a plurality of filaments extending out from spaced locations on an end of the covering membrane, crossing the space between one of the anchoring members and the covering membrane, and converging to a single point of the one of the anchoring members. The closest prior art appears to be Brodbeck et al. (US 2007/0179599) disclosing a similar stent graft, but failing to disclose or teach the specific mounting member structural configuration as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see:
Solovay (US 5,769,884) teaching various membrane porosities wherein membrane end porosity is greater than the porosity at the middle of the membrane; and
Quijano et al. (US 5,500,014) teaching arching support members.
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 Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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