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 with respect to claim(s) 1, 4, 15, and 24 regarding the single unit implantation have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues with respect to claim 1 that the wires are not displaced at the opening, the examiner disagrees, noting in [0069] the wires are wound around the mandrel and instead of the opening being wound closed as it typically would be, a side branch exists on the mandrel that displaces the wires around the opening to form a hole.
Claim Objections
Claim 1, 3-5, 7-8, 10-12, 15-18, 20-22, and claim 24 are objected to because of the following informalities:
Claims 1, 3-5, 7-8, 10-12, 15-18, 20-22 contain reference numbers that refer to specific figures, however the claims should not refer to specific figures (MPEP 2173.05(s)).
Claim 1 recites “in an expanded state” and “in a contracted state” but the claim should recite “an expanded state” and “a contracted state”
Claim 7 and 17 recite “the first and second braided section” but should recite “the first and second braided sections”
Claim 7 and 17 recite “the opening in the wall” and “the openings in the walls” the labels should be consistent.
Claim 7 and 17 recite “in the middle with respect to the longitudinal extension,” it is unclear how the opening is placed in “the middle with respect to,” the language should define clearly if the longitudinal extension is singular or plural and should recite something like “in the middle of the longitudinal extensions of the first and second braided sections”
Claim 12 recites “the braided sections,” but should recite “the first or second braided sections”’
Claim 15 recites “the blood vessel” but should recite “a blood vessel”
Claim 15 recites “the braided structure” but should recite “the single braided structure”
Claim 20 recites “a material having shape memory properties” but is dependent on 18 so should recite “the material having shape memory properties” if it is referring to the same material as in claim 18.
Claim 24 recites “a first side-wall opening” with “said first opening” and “a second side-wall opening” with “said second opening” but labels should remain consistent.
Appropriate correction is required.
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.
Claim 1, 3-5 and 7-13 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 recites “can be moved to a target position” however the broad and indefinite scope of the limitation “can be” fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite.
Dependent claims are likewise rejected.
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.
Claim(s) 1, 3-5, 7-9, 12, 15-19, 22, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 20210282944 A1) in view of Gainor (AU 2014227955 A1).
Regarding claim 1, Chen teaches an implant for influencing the flow of blood in an area of aneurysms which are localized at vessel branchings ([0002-0003]), wherein the implant has an expanded state in which the implant is implanted in a blood vessel and in a contracted state in which the implant is movable through the blood vessel ([0005],[0043]), with the implant having a first (element 112) and a second braided section (element 102) which are tubular in the expanded state, wherein the first and second braided section have a wall that is composed of wires interwoven with one another ([0003], [0005-0007]), the first and second braided sections each having an opening in the wall ([0003]), with at least the size of the opening in the second braided section being sufficient for the passage of the first braided section ([0036], sidewall 108 is sufficient for the passage of stent 112 to pass) wherein the openings in the wall being produced in such a way that the wires forming the first and second braided sections are radially displaced at the positions of the openings ([0069], wrapped around mandrel and displaced), and the first braided section is guided through the opening in the wall of the second braided section such that the opening in the wall of the first braided section opposes and communicates to the opening in the wall of the second braided section ([0036], fig 1).
Chen fails to teach the single unit implantation. Gainor teaches a stent implanted in the body (abstract) by the same inversion method as discussed in the claim wherein the stent has a first and second section (see two sections of fig 1) wherein the second section is sufficient for the passage of the first section and the first section is guided through the second section (see figure 1 and 2) and wherein the stent is implanted as a single unit (fig 2). By applying the teaches of the folding inversion technique of Gainor to the two sections of the stent device in Chen, an implant is taught wherein the first and second sections of Chen seen at the bottom of figure 1 are attached longitudinally in and orientation that allows for the resultant implant of figure 1 seen on the top of the figure. The combination further teaches wherein the implant is assembled prior to insertion into the blood vessel (the device of Chen modified by the single unit folding of Gainor teaches an assembly completed prior to delivery) and can be moved to a target position within the blood vessel as a single unit (the device of Chen modified by the single unit folding of Gainor teaches a single unit implantation).
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 device taught by Chen by applying the teaching of the stent inversion, as taught by Gainor, in order to create an implant with a smaller profile that optimizes delivery ([0001-0013]).
Regarding claim 3, Chen further teaches wherein in the expanded state, the first and second braided sections have a segment which the first and second braided sections jointly extend and overlap, in such a way that the inner braided section and an outer braided section is formed and projects beyond the outer braided section ([0038], fig 5e).
Regarding claim 4, Chen further teaches wherein the first and the second braided sections have a segment in which the first and second braided sections jointly extend.
Chen fails to exactly teach the connection with no free wires. Gainor teaches a stent implanted in the body (abstract) by the same inversion method as discussed in the claim wherein the stent has a first and second section (see two sections of fig 1) wherein the second section is sufficient for the passage of the first section and the first section is guided through the second section (see figure 1 and 2) and wherein the stent is implanted as a single unit (fig 2). By applying the teaches of the folding inversion technique of Gainor to the two sections of the stent device in Chen, an implant is taught where the first and second braided sections are connected to each other such that there are no free wire ends at the outer end (with the inversion method no free wires are present and sections are connected).
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 device taught by Chen by applying the teaching of the stent inversion, as taught by Gainor, in order to create an implant with a smaller profile that optimizes delivery ([0001-0013]).
Regarding claim 5 and 16, Chen further teaches wherein the first and second braided sections are attached to each other at their openings (fig 1, [0037-0038]).
Regarding claim 7 and 17, Chen further teaches wherein the first and second braided sections have a longitudinal extension and wherein the openings in the wall of the first and/or second braided section are arranged approximately in the middle with respect to the longitudinal extension (fig 1, fig 4a, sections have a longitudinal extension inherently, the openings are approximately in the middle).
Regarding claim 8 and 18, Chen further teaches wherein the wires are composed at least partially of a material having shape memory properties ([0005-0007]).
Regarding claim 9 and 19, Chen further teaches wherein the material having shape memory properties is a nickel-titanium alloy ([0005]).
Regarding claim 12 and 22, Chen further teaches wherein the implant has one or several membranes at least partially covering the braided sections ([0020], sheath).
Regarding claim 15, Chen teaches an implant for influencing the flow of blood in an area of aneurysms which are localized at vessel branchings ([0002-0003]), wherein the implant has an expanded state configured for implantation at a bifurcation in the blood vessel and a contracted state in which the implant (18) is movable through the blood vessel ([0005],[0043]), with the implant having has a wall that is composed of wires interwoven with one another ([0003], [0005-0007]), wherein the braided structure has a first (element 112) and a second braided section (element 102) each having an opening in the wall ([0003]), with at least the size of the opening in the second braided section being sufficient for the passage of the first braided section ([0036], sidewall 108 is sufficient for the passage of stent 112 to pass) wherein the two openings are located on opposite sides of the braided structure (fig 1 or fig 5e) and the first braided section is turned inwardly, and the first braided section passing through the interior of the second braided section and extending through the opening in the second braided section from the inside to the outside (fig 5e) in such a manner that the opening in the wall of the first braided section faces the opening in the wall of the second braided section (fig 1, [0037-0038]).
Chen fails to teach the single longitudinal structure. Gainor teaches a stent implanted in the body (abstract) by the same inversion method as discussed in the claim wherein the stent has a first and second section (see two sections of fig 1) wherein the second section is sufficient for the passage of the first section and the first section is guided through the second section (see figure 1 and 2) and wherein the stent is implanted as a single unit (fig 2). By applying the teaches of the folding inversion technique of Gainor to the two sections of the stent device in Chen, an implant is taught wherein the implant has a single braided structure (the combination would be a single structure) which is tubular in the expanded state (the combination would create a tubular structure), and wherein a first (element 112) and a second braided section (element 102) which are longitudinally adjacent and arranged one after the other ((the combination would create a this structure).
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 device taught by Chen by applying the teaching of the stent inversion, as taught by Gainor, in order to create an implant with a smaller profile that optimizes delivery ([0001-0013]).
Regarding claim 24, Chen teaches a flow diverter for implantation in a bifurcation of a vascular system in a patient ([0002-0003], fig 1) aid flow diverter comprising, the diverter comprising a tube composed of braided wires ([0003], [0005-0007]), wherein the tube structure is characterized by a wall (for example element 112 or 102), a first side-wall opening in the wall of the tube (see fig 1, element 108) said first opening in a first side of the tube (see element 108 on left side) a second side-wall opening in the wall of the tube (fig 1, element 118) said second opening in a second side of the tube, said second side opposite the first side (see element 118 on right side) and a portion of the structure is passed through the first opening to form two distal implant arms (see branched arms in figure 1 after stent is passed through), such that:(1) the second side-wall opening is positioned proximate the first side-wall opening (fig 1, ([0037-0038]) to allow blood flow through the first side-wall opening and the second side-wall opening (structure is capable of this) ; and (2) a portion of the second structure is disposed within the portion of the first structure (see figure 1, the second stent structure is passed through the first) to form a proximal implant arm (fig 1, see branched arms) with a proximal implant arm opening proximate a midpoint of the tube (see figure 1, arm openings are in a middle section of the structure).
Chen fails to teach the single tubular structure. Gainor teaches a stent implanted in the body (abstract) comprising a single tube (fig 1) said single tube having a first end (see fig 1) and a second end (see fig 1) and a midpoint between the first and second end (see fig 1), aid tube characterized by a wall (see fig 1), wherein the second end is everted into the first end (see fig 2)
By applying the teaches of the folding inversion technique of Gainor to the two sections of the stent device in Chen, an implant is taught wherein a first side-wall opening in the wall of the tube in the first end and a second side-wall opening in the wall of the tube in the second end (the combination would be a single structure oriented in this way), and a portion of the second end is passed through the first opening to form two distal implant arms to allow blood flow from the first end through the openings a portion of the second end between the second opening (the combination structure is capable of this) and the midpoint is disposed within the portion of the first end between the first opening and the midpoint (the combination would be a single structure oriented in this way) and wherein no free wires ends at the proximal implant arm openings (when stent structures are combined no free wires are present).
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 device taught by Chen by applying the teaching of the stent inversion, as taught by Gainor, in order to create an implant with a smaller profile that optimizes delivery ([0001-0013]).
Claim(s) 10-11 and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 20210282944 A1) in view of in view of Gainor (AU 2014227955 A1) and in further view of Mitha (US 20200229954 A1).
Regarding claim 10 and 20, Chen fails to teach a radiopaque core material. Mitha teaches a flow diverting stent (abstract) wherein the wires comprise a core of a radiopaque material ([0019]) and a sheath of a material having shape memory properties ([0019]).
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 device taught by Chen by including the wire makeup, as taught by Mitha, in order to aid in visualization ([0017]).
Regarding claim 11 and 21, Chen fails to teach a radiopaque marker. Mitha teaches a flow diverting stent (abstract) wherein the implant has radiopaque markers ([0096-0098]).
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 device taught by Chen by including the radiopaque properties, as taught by Mitha, in order to aid in visualization ([0096-0098]).
Claim(s) 13 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 20210282944 A1 in view of in view of Gainor (AU 2014227955 A1) and in further view of Eker (WO 2018134097 A1).
Regarding claim 13 and 23, Chen fails to exactly teach an antithrombogenic/endothelial effect. Eker teaches a bifurcated stent (abstract) wherein the one or several membranes (pg. 11, lines 4-9, outer surface coating would be membrane) have an antithrombogenic effect or an effect that promotes endothelial formation (pg. 11, lines 4-9).
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 device taught by Chen by including coating, as taught by Eker, in order to add known benefits and properties of antithrombosis to the implant.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 8:30PM-4:30PM EST M-F (occasionally off Fridays).
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/H.L.P./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
Prosecution Insights