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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/18/2025 has been entered.
Status of Claims
This office action is responsive to the amendment filed on 09/04/2025. As directed by the amendment: claims 1, 3-5, 8 and 10-12 have been amended, no additional claims have been cancelled, no new claims have been added, and claims 6, 7 and 13-24 remain withdrawn from examination as being drawn to a non-elected invention/species. Thus, claims 1, 3-5, 8 and 10-12 are presently examined in the current Office Action.
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.
Claims 1, 3-5, 8 and 10-12 are 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.
Regarding claim 1, which recites the limitation “said flexible connector elements”, on lines 4-5, 16 and the last line; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this issue, it is suggested the words “shape-memory” be added between the words “said” and “flexible”. Furthermore, lines 16-17 set forth the parameter of “a first thickness in an axial direction in a flexing plane which is perpendicular to a longitudinal axis of the aortic stent-graft” (emphasis added); however this parameter is found to be confusing since it is not clear how and axial direction, in a flexing plane, can be perpendicular to a longitudinal axis of the aortic stent-graft and/or if the flexing plane is perpendicular to a longitudinal axis of the aortic stent-graft, then how can the axial direction be in this flexing plane. For the purpose of examination the above mentioned parameter shall be interpreted as “a first thickness in an axial direction in a flexing plane”; and amendment as such, or to further clarify the parameter is suggested.
Regarding claim 4, which recites the limitations “said aortic stent connector” and “said connector elements”, both on line 2; there is insufficient antecedent basis for these limitations in the claim. In order to overcome this rejection, it is suggested the words “self-expanding, shape memory” be added between the words “said” and “aortic”, in the first limitation mentioned above, and the words “shape-memory flexible” be added between the words “said” and “connector”, in the second limitation mentioned above.
Regarding claim 5, which recites the limitations “said aortic stent connector” and “said flexible connector elements”, both on line 2; there is insufficient antecedent basis for these limitations in the claim. In order to overcome this rejection, it is suggested the words “self-expanding, shape memory” be added between the words “said” and “aortic”, in the first limitation mentioned above, and the words “shape-memory” be added between the words “said” and “flexible”, in the second limitation mentioned above.
Regarding claim 8, which recites the limitations “said connector”, on line 6, “said aortic stent-graft”, on lines 11 and 16, and “said stent-graft’s” on line 13; there is insufficient antecedent basis for these limitations in the claim. In order to overcome this issue, it is suggested the words “shape-memory” be added between the words “said” and “connector”, on line 6, the words “self-expanding, shape memory” be added between the words “said” and “aortic”, on lines 11 and 16, and the words “self-expanding, shape memory aortic” be added between the words “said” and “stent-graft’s”, on line 13. Furthermore, lines 15-16 set forth the parameter of “a first thickness in an axial direction in a flexing plane which is perpendicular to a longitudinal axis of the aortic stent-graft” (emphasis added); however this parameter is found to be confusing since it is not clear how and axial direction, in a flexing plane, can be perpendicular to a longitudinal axis of the aortic stent-graft and/or if the flexing plane is perpendicular to a longitudinal axis of the aortic stent-graft, then how can the axial direction be in this flexing plane. For the purpose of examination the above mentioned parameter shall be interpreted as “a first thickness in an axial direction in a flexing plane”; and amendment as such, or to further clarify the parameter is suggested.
Regarding claim 11, which recites the limitation “said connector”, on line 2; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection, it is suggested the words “shape-memory” be added between the words “said” and “connector”.
Regarding claim 12, which recites the limitations “said connector”, on line 2, and “said aortic stent-graft”, on the last line; there is insufficient antecedent basis for these limitations in the claim. In order to overcome this rejection, it is suggested the words “shape memory” be added between the words “said” and “connector”, on line 2, the words “self-expanding, shape memory” be added between the words “said” and “aortic”, on the last line.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 1 and 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Prabhu et al. (US PG Pub. 2007/0239251), hereinafter Prabhu, in view of Fischell et al. (US Patent No 7,060,088), hereinafter Fischell.
Regarding claims 1 and 3, Prabhu discloses a self-expanding, shape memory aortic stent connector (18), illustrated in Figures 3 and 5-7, comprising a plurality of shape memory flexible connector elements (18), each of which include a first element leg (54), comprising a first flange (60), structured to be attached to a first peak (44) of a first stent (12), and a second element leg (54), comprising a second flange (62), structured to be attached to a second peak (42) of a second stent (12), wherein the first and second element legs (54) are flexibly connected at a vertex (58) thereby forming a substantially V-shape, the plurality of flexible connector elements (18) connect said first and second stents (12) axially such that the stents have flexibility to conform to an angle of a vessel after installation and expansion, and flex longitudinally along said stent's longitudinal axis in response to impulses of blood in the vessel after expansion, illustrated in Figures 3 and 5-7 ([0001], Lines 1-3; [0008], Last 4 Lines; [0059]; [0063]; [0064], Lines 1-3; [0068] & [0079] – To clarify, it is stated the links/connectors 18 are formed of shape memory polymers such as polyurethanes and polyether-amide thermoplastic elastomer, and it is also stated that the entire stent, which would include the connectors, can be made from a shape memory alloy such as nickel-titanium. Additionally, it is stated that the device of Prabhu is designed for use in arteries, among other blood vessels, and that the overall shape and size can be varied to accommodate different vessels or body lumen; thus it would have the structure to be implanted in an aorta/be an aortic stent connector); but does not specifically teach each of the flexible connector elements have a first thickness in an axial direction, in a flexing plane, that is less than a second thickness in a radial direction, in a plane that resists loss of radial strength transferred from said first stent to said second stent.
However, Fischell teaches a stent connector elements (14), in the same field of endeavor, adapted to connect two stents (12), illustrated in Figure 2, wherein each stent connector element (14) has a first thickness (15) in an axial direction, in a flexing plane, that is less than a second thickness (25) in a radial direction, in a plane that resists loss of radial strength transferred from said first stent to said second stent, illustrated in Figure 3 (Column 5, Lines 37-41); this combination of the first thickness, in an axial direction, being less than the second thickness, in a radial direction, allows the connector elements to easily lengthen and shorten for increased/improved stent flexibility, while still maintaining a radial stiffness to avoid inward bulging and ability to push plaque outward/toward the vessel wall (Column 5, Lines 48-56).
In view of the teachings of Fischell, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the flexible connector elements, of the self-expanding, shape memory aortic stent connector of Prabhu, to have a first thickness in an axial direction, in a flexing plane, that is less than a second thickness in a radial direction, in a plane that resists loss of radial strength transferred from said first stent to said second stent, in order to allow the flexible connector elements to have increased/improved stent flexibility, while also maintaining a relative radial stiffness, as taught by Fischell.
Regarding claim 4, Prabhu in view of Fischell disclose the self-expanding, shape memory aortic stent connector according to claim 1, wherein Prabhu further teaches a same number of said shape memory flexible connector elements (18) as there are of the first and second peaks (44/42) of the first and second stents (12), illustrated in Figure 5 (Prabhu: [0069], Lines 5-9).
Regarding claim 5, Prabhu in view of Fischell disclose the self-expanding, shape memory aortic stent connector according to claim 1, wherein Prabhu further teaches fewer of said shape memory flexible connector elements (18) than there are of the first and second peaks (44/42) of the first and second stents (12) to thereby eliminate interference between the first and second stents where the first and second stents are closest to each other when the aortic stent-graft is bent, illustrated in Figures 6 and 7 (Prabhu: [0071], Lines 9-11).
Claims 8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Prabhu in view of Fischell and Beach et al. (US PG Pub. 2010/0286760), hereinafter Beach.
Regarding claims 8 and 10, Prabhu discloses a self-expanding, shape memory aortic stent (10), illustrated in Figures 3 and 5-7, comprising at least first and second stents (12), and a shape memory connector (18) which connects the first and second stents (12); the shape memory connector comprising a plurality of flexible connector elements (18), each of which include a first element leg (54), comprising a first flange (60), structured to be attached to a first peak (44) of a first stent (12), and a second element leg (54), comprising a second flange (62), structured to be attached to a second peak (42) of a second stent (12), wherein the first and second element legs (54) are flexibly connected at a vertex (58) thereby forming a substantially V-shape, the plurality of flexible connector elements (18) connect said first and second stents (12) axially such that said aortic stent-graft (10) has flexibility to conform to an angle of an aorta after installation and expansion, and flex longitudinally along said stent's longitudinal axis in response to impulses of blood in the aorta after expansion, illustrated in Figures 3 and 5-7 ([0001], Lines 1-3; [0008], Last 4 Lines; [0059]; [0063]; [0064], Lines 1-3; [0068] & [0079] – To clarify, it is stated the links/connectors 18 are formed of shape memory polymers such as polyurethanes and polyether-amide thermoplastic elastomer; and it is also stated that the entire stent, which would include the connectors, can be made from a shape memory alloy such as nickel-titanium. Additionally, it is stated that the device of Prabhu is designed for use in arteries, among other blood vessels, and that the overall shape and size can be varied to accommodate different vessels or body lumen; thus the device of Prabhu would have the physical/structural ability to be implanted in an aorta/be an aortic stent); but does not specifically teach each of the flexible connector elements have a first thickness in an axial direction, in a flexing plane, that is less than a second thickness in a radial direction, in a plane that resists loss of radial strength transferred from said first stent to said second stent, and that the aortic stent comprises a length of graft material supported by the first and second stents.
However, Fischell teaches a stent connector elements (14), in the same field of endeavor, adapted to connect two stents (12), illustrated in Figure 2, wherein each stent connector element (14) has a first thickness (15) in an axial direction, in a flexing plane, that is less than a second thickness (25) in a radial direction, in a plane that resists loss of radial strength transferred from said first stent to said second stent, illustrated in Figure 3 (Fischell: Column 5, Lines 37-41); this combination of the first thickness, in an axial direction, being less than the second thickness, in a radial direction, allows the connector elements to easily lengthen and shorten for increased/improved stent flexibility, while still maintaining a radial stiffness to avoid inward bulging and ability to push plaque outward/toward the vessel wall (Fischell: Column 5, Lines 48-56). Additionally, Beach teaches an aortic stent, in the same field of endeavor, wherein the stent can comprise a length of graft material, thereby forming an aortic stent-graft; such a structure of a stent with a graft material, i.e. a stent-graft, can be used to treat aneurysms and dissections (Beach: [0018]).
In view of the teachings of Fischell and Beach, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the flexible connector elements, of the self-expanding, shape memory aortic stent connector of Prabhu, to have a first thickness in an axial direction, in a flexing plane, that is less than a second thickness in a radial direction, in a plane that resists loss of radial strength transferred from said first stent to said second stent, in order to allow the flexible connector elements to have increased/improved stent flexibility, while also maintaining a relative radial stiffness, as taught by Fischell. It further would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the aortic stent, of Fischell, to further comprise a length of graft material supported by the first and second stents, thereby forming an aortic stent-graft, in order to treat an aneurysm and/or dissection, as taught by Beach.
Regarding claim 11, Prabhu in view of Fischell and Beach disclose the self-expanding, shape memory aortic stent-graft according to claim 8, wherein Prabhu further teaches a same number of said shape memory flexible connector elements (18) as there are of the first and second peaks (44/42) of the first and second stents (12), illustrated in Figure 5 (Prabhu: [0069], Lines 5-9).
Regarding claim 12, Prabhu in view of Fischell and Beach disclose the self-expanding, shape memory aortic stent-graft according to claim 8, wherein Prabhu further teaches fewer of said shape memory flexible connector elements (18) than there are of the first and second peaks (44/42) of the first and second stents (12) to thereby eliminate interference between the first and second stents where the first and second stents are closest to each other when the aortic stent-graft is bent, illustrated in Figures 6 and 7 (Prabhu: [0071], Lines 9-11).
Response to Arguments
Applicant’s arguments with respect to independent claims 1 and 8 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.
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774