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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/24/26 has been entered.
Response to Arguments
Applicant’s arguments, filed 4/24/26, with respect to the 35 USC 112 rejections have been fully considered and are persuasive. The rejections under 35 USC 112 of claims 1-4, 6-10, 12-16 and 18 have been withdrawn.
Applicant's arguments filed 4/24/26 have been fully considered but they are not persuasive.
Applicant argues the amendment including the connection section providing a degree of movement of said side branch and maintaining a substantially equal diameter throughout a length of the connection section to promote smooth blood flow to prevent clot formation at said connection section is not disclosed in the prior art.
However, Greenan et al. US 2007/0244542 discloses connection section being a single pleat connecting the main body with the side branch (see annotated figure. 3 below). The diameter of the pleat at the connection may be considered to be substantially the same, as it forms the cylindrical tube shape forming the side branch. Particularly in the expanded configuration, the pleat will be extended lengthwise form less of an accordion shape along the single pleat, and more of a straight tube shape wherein the diameter will be substantially equal along the length. Examiner further notes that the claim requires a substantially equal diameter throughout a length of the connection section, however, that length may be considered any portion of the connection section resulting in a section that has a substantially equal diameter. Being substantially equal does not require a connection portion that is exactly equal or free of slight undulations and may include partially tapered edges to allow for the movement and placement of the side branch as also required by the claim. The structure as claimed is disclosed in Greenan et al. as shown below in fig. 3, however, fails to explicitly disclose preventing clot
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formation at said connection section.
However, Moloney further explicitly discloses that smooth surfaces of a connection section branch stent allow for less turbulent flow to prevent restenosis at the target bifurcated vessel (figures 1-3, paragraph 0030-0031, connection portion 110 of side branch 100), said connection section comprises a curved inner section shaped and finished (116, 126, figure 1, paragraph 0030, 0031) to promote smooth blood flow to prevent clot formation (paragraph 0007, 0031), and further a sided branch stent 100 being further coated with a therapeutic agent to prevent stenosis such as an anticoagulant to prevent blood clotting and reduce the probability for undesired side effects such as restenosis (paragraph 0043). The combination of the structure and further coatings will result in smooth blood flow through the connection section for clot prevention.
Claim Objections
Claim 7 is objected to because of the following informalities: “to prevent clot” on line 9 should be changed to “to prevent clots” or “to prevent clot formation”. Appropriate correction is required.
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) 1-4, 6-10, 12, 14-16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenan et al. US 2007/0244542 in view of Ferrera US 2004/0193246 and in view of Moloney US 2009/0259293.
Regarding claims 1 and 7, Greenan et al. discloses a covered stent (paragraph 0053, stent graft 200, figures 2, 3) comprising a lateral side branch 205 (figures 2, 3) extending from a main body of the covered stent (paragraph 0055, figures 2, 3), said lateral side branch comprising a supporting frame (paragraphs 0004, radially expandable reinforcement structure formed from a plurality of annular stent rings), the supporting frame having a frame pattern for improved collapsibility of the stent (paragraph 0056, 0058, flexible and articulatable characteristics of an elephant trunk and to accommodate a degree of misalignment), and two halves such that the lateral side branch is collapsible in a middle region (for example, figures 4B, 4C, paragraph 0061, first half including 2063C, second half including 2063A; similarly, figures 5D-5F, branch shown collapsed throughout the branch including the middle region in figure 5F), and a connection section at least partly in the main body (see annotated figure 3 below, connection section of lateral side branch 205 and main body 200 coupled at aperture 210, paragraph 0021, 0055), configured to provide a degree of movement of said side branch (pleats or corrugations provide flexible, articulable, and axial compression properties to the branch graft, connection section being the first pleat section, figure 3, paragraph 0021, 0056, 0063), and maintaining a substantially equal diameter throughout a length of the connection section to promote smooth blood flow (diameter of the pleat at the connection may be considered to be substantially the same, as it forms with the cylindrical tube shape forming the side branch, particularly in the expanded configuration, the pleat will be expanded lengthwise form less of an accordion shape along the single pleat, further that the claim requires a substantially equal diameter throughout a length of the connection section, however, that length may be considered any portion of the connection section resulting in a section that has a substantially equal diameter, being substantially equal does not require a connection portion that is exactly equal and may include partially tapered edges to allow for the movement and placement of the side branch as required by the claim) wherein said connection section integrally connects the lateral side branch tiltable-moveable relative to the main body (paragraph 0021, see annotated figure 3 below, integrally coupled to the main body at the branch opening aperture, paragraph 0056, flexible and articulatable characteristics of an elephant trunk and to accommodate a degree of misalignment or tiltable movement).
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Greenan et al. discloses asymmetrical branches (for example, figure 5D, 5E) and a supporting frame (paragraphs 0004, 0056), but fails to explicitly disclose the supporting frame in the lateral side branch has a supporting frame pattern with an asymmetrical design for improved collapsibility of the stent, or the frame pattern of two halves such that the branch is collapsible in a middle region.
Ferrera teaches a stent having frame pattern with an asymmetrical design for improved collapsibility of the stent and allow for readjustments once positioned (paragraph 0085, figures 9A, 9B, struts are Z-folded, distorted or curved for collapsibility and elongation and to allow for position readjustments), the supporting frame having a frame pattern of two halves such that the branch is collapsible in a middle region (figures 9A, 9B, middle region at the Z-fold, distorted or curved region).
Greenan et al. discloses a connection section comprising only the first segment or pleat adjacent the main body, thereby providing an uncorrelated portion (figure 3) which has a substantially equal diameter throughout a length (figure 3), but fails to explicitly disclose wherein said length of the connection section promotes smooth blood flow to prevent clot formation.
Moloney further explicitly discloses that smooth surfaces of a connection section branch stent allow for less turbulent flow to prevent restenosis at the target bifurcated vessel (figures 1-3, paragraph 0030-0031, connection portion 110 of side branch 100), said connection section comprises a curved inner section shaped and finished (116, 126, figure 1, paragraph 0030, 0031) to promote smooth blood flow to prevent clot formation (paragraph 0007, 0031), and further a sided branch stent 100 being further coated with a therapeutic agent to prevent stenosis such as an anticoagulant to prevent blood clotting and reduce the probability for undesired side effects such as restenosis (paragraph 0043).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify Greenan et al. with a connection section shaped and finished, as taught by Moloney, as it is known in the art to promote smooth blood flow and prevent clot formation and reduce the probability for undesired side effects such as restenosis.
Regarding claims 2, 8, and 14, Greenan et al. in combination discloses a covered stent essentially as claimed as discussed above, but fails to explicitly disclose the supporting frame being made of nitinol.
Ferrera teaches a supporting frame pattern being made of nitinol to allow for superelastic properties or shape memory (paragraph 0014).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the frame to be made of nitinol, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claims 3, 9, and 15, Greenan et al. in combination discloses a covered stent essentially as claimed as discussed above, but fails to explicitly disclose the supporting frame being a laser cut structure.
Ferrera teaches a supporting frame pattern being laser cut structure (paragraph 0012).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Greenan et al. with a laser cut structure, as taught by Ferrera, as it is known in the art to laser cut stent structures to provide the frame configuration as desired. Examiner additionally notes that “[E]ven 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). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.2.
Regarding claims 4, 10, and 16, Greenan et al. in combination discloses a covered stent (paragraph 0053, stent graft 200, figures 2, 3) comprising a lateral side branch 205 extending from a main body of the stent (paragraph 0055, figures 2, 3), a supporting frame in the lateral side branch (reinforced structure, paragraph 0004) as discussed above, but fails to explicitly disclose the stent or frame pattern has a region without a supporting frame.
Ferrera teaches wherein the pattern or stent has a region without a supporting frame to allow for collapsibility or expansion for readjustments (paragraph 0085, figure 9B, collapsible portion allows for an additional empty space between the rings).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Greenan et al. with a pattern without a supporting frame, as taught by Ferrera, to frame to allow for collapsibility or expansion of that portion of the stent graft as required for adjustability.
Regarding claims 6, 12 and 18, Greenan et al. discloses wherein the lateral side branch comprises a connection point configured to connect a guiding element (paragraph 0022, guiding elements or bare spring elements maybe connected at a connection point to the graft material of the main body or the lateral branch graft).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenan et al. US 2007/0244542 in view of Moloney US 2009/0259293.
Regarding claim 13, Greenan et al. discloses a covered stent (paragraph 0053, stent graft 200, figures 2, 3) comprising a lateral side branch 205 of a length (figure 2) extending from a main body of the covered stent (paragraph 0055, figures 2, 3), said lateral side branch comprising a supporting frame or a supporting frame in the lateral side branch (paragraphs 0004, radially expandable reinforcement structure formed from a plurality of annular stent rings), the covered stent 200 has a region without the supporting frame (figures 2, 3, paragraph 0055, main body has opening or aperture 210 to receive side branch, aperture does not have a supporting frame within), and a connection section positioned on the main body (see annotated figure 3 below, connection section of lateral side branch 205 and main body 200 coupled at aperture 210, paragraph 0021, 0055), configured to provide a degree of movement of said side branch (pleats or corrugations provide flexible, articulable, and axial compression properties to the branch graft, connection section being the first pleat section, figure 3, paragraph 0021, 0056, 0063), and maintaining a substantially equal diameter throughout a length of the connection section to promote smooth blood flow (diameter of the pleat at the connection may be considered to be substantially the same, as it forms with the cylindrical tube shape forming the side branch, particularly in the expanded configuration, the pleat will be expanded lengthwise form less of an accordion shape along the single pleat, further that the claim requires a substantially equal diameter throughout a length of the connection section, however, that length may be considered any portion of the connection section resulting in a section that has a substantially equal diameter, being substantially equal does not require a connection portion that is exactly equal and may include partially tapered edges to allow for the movement and placement of the side branch as required by the claim) wherein said connection section integrally connects the lateral side branch tiltable-moveable relative to the main body (paragraph 0021, see annotated figure 3 below, integrally coupled to the main body at the branch opening aperture, paragraph 0056, flexible and articulatable characteristics of an elephant trunk and to accommodate a degree of misalignment or tiltable movement).
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Greenan et al. discloses a connection section comprising only the first segment adjacent the main body, thereby providing an uncorrelated portion (figure 3) which has a substantially equal diameter throughout a length forming the perimeter around the connection segment or pleat adjacent the main body (figure 3), but fails to explicitly disclose wherein said length of the connection section promotes smooth blood flow to prevent clot formation.
Moloney further explicitly discloses that smooth surfaces of a connection section branch stent allow for less turbulent flow to prevent restenosis at the target bifurcated vessel (figures 1-3, paragraph 0030-0031, connection portion 110 of side branch 100), said connection section comprises a curved inner section shaped and finished (116, 126, figure 1, paragraph 0030, 0031) to promote smooth blood flow to prevent clot formation (paragraph 0007, 0031), and further a sided branch stent 100 being further coated with a therapeutic agent to prevent stenosis such as an anticoagulant to prevent blood clotting and reduce the probability for undesired side effects such as restenosis (paragraph 0043).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify Greenan et al. with a connection section shaped and finished, as taught by Moloney, as it is known in the art to promote smooth blood flow and prevent clot formation and reduce the probability for undesired side effects such as restenosis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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