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
Applicant’s arguments filed 9/14/26 have been fully considered but they are not persuasive.
Applicant argues the amendment including the connection section positioned on the main body and devoid of pleats, ridges, or other surface discontinuities is not disclosed in the prior art.
However, Greenan et al. US 2007/0244542 discloses connection section being a single section connecting the main body with the side branch (see annotated fig. 3 below). Examiner notes when only taking into consideration the connection section (or one single section as shaded in annotated figure 3 below), the connection section will not comprise any pleats, ridges, or other surface discontinuities. Examiner notes the “section” can be considered any portion at the attachment point. The claim does not require that the entire lateral side branch being devoid of pleats, ridges or other surface discontinuities.
Further, “devoid of pleats, ridges, or other surface discontinuities” is a negative limitation. The mere absence of a positive recitation is not basis for an exclusion. Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. MPEP 2173.05(I). Examiner notes the specification discloses the connection section providing a degree of movement, but fails to explicitly disclose it is free of pleats, ridges or discontinuities.
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Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6-10, 12-16 and 18-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amendment including the connection section being “devoid of pleats, ridges, or other surface discontinuities” is a negative limitation. The mere absence of a positive recitation is not basis for an exclusion. Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. MPEP 2173.05(I). Examiner notes the specification discloses the connection section providing a degree of movement, but fails to explicitly disclose it is free of pleats, ridges or discontinuities or how the degree of movement is provided. For example, the connection section 3a may be tilted thereby configured to form a ridge along the connection. These specific limitations do not have sufficient support from the figures or disclosure.
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 18-21 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, 7 and 19-21, 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 (connection section being the first section allowing for movement, 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 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 section will be expanded lengthwise form less of an accordion shape along the single section, 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), wherein the lateral side branch further comprises a region without a supporting frame (for example, paragraph 0085, figure 9B, collapsible portion allows for an additional empty space between the rings void of the circumferential struts in a middle portion) to change the shape or length (paragraph 0085).
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. the supporting frame in the lateral side branch has a supporting frame pattern with an asymmetrical design or frame of two halves, as taught by Moloney, as it is known in the art for improved collapsibility of the stent.
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 (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
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
