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 4/2/2026. 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 Rejections/objections not repeated herein have been withdrawn.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 pages 8-9, with respect to Applicant’s amendments to the drawings, claims and specification made in view of the previous objections to the drawings have been fully considered and are persuasive. The previous objections to the drawings have been withdrawn.
Applicant’s arguments, see page 9, with respect to Applicant’s amendments to the claims 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 The previous claim objections have been withdrawn.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 page 9, with respect to Applicant’s amendments to the claims made in view of the previous 112 rejections have been fully considered and are persuasive. The previous 112 rejections have been withdrawn.
Applicant’s arguments, see pages 10-11, with respect to the deficiencies of Robichon failing to disclose that “the fitted end only comprises the plurality of second supports and is free of the second tubular graft member” have been fully considered and are persuasive. Therefore, the previous prior art rejections have been withdrawn. However, upon further consideration, new ground(s) of rejection are made further in view of Brightbill (US 7,771,464), as set forth below.
Applicant’s arguments, see pages 10-11, with respect to the deficiencies of the prior art of recording failing to disclose or teach the “venous-confluence architecture” alleged by Applicant have been fully considered but they are not persuasive. In response to applicant's argument that the prior art of recording fails to disclose or teach the “venous-confluence architecture”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As set forth in the previous office action, Robichon expressly discloses multiple different uses for its device/system including uses in both arteries and veins as treatments for aneurysms, stenoses, and the like (col. 3, lines 8-15). Affirmatively claiming a specific vasculature-confluence architecture would potentially invite one or more further 101 rejections, as necessary (i.e., Applicant’s argument appears more suited to a method claim). For at least these reasons, Applicant’s arguments are not persuasive.
In response to applicant’s argument (see pages 12-13) that there is no teaching, suggestion, or motivation to combine references by introducing a fitting member in the form of the diaphragm arrangement taught by the Quinn prior art reference, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as expressly set forth in the previous office action, Quinn expressly teaches that it is known that a diaphragm fitting member and a lateral tubular duct fitting member are elements that are functional equivalents for providing a partition with a primary graft sleeve of a bifurcated intravascular stent graft. Such a motivation and/or rationale to combine a simple substitution of one known element for another to obtain predictable results (see MPEP 2143(I)(B) and 2141(III)). For at least these reasons, Applicant’s arguments are not persuasive.
In response to applicant's argument (see page 13) that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As set forth in the previous office action, each of the combinations of Cragg and/or Quinn with the primary reference of Robichon expressly includes a KSR simple substitution rationale and/or a direct citation to a proper motivational statement found within the prior art itself (see paragraphs 39, 42 and 45 of the previous office action). For at least these reasons, Applicant’s arguments are not persuasive.
Claim Rejections - 35 USC § 103
Claim(s) 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Robichon et al. (US 6,102,940) in view of Cragg et al. (US 2011/0130826) and Brightbill (US 7,771,464).
Robichon discloses (see Figs. 3-7) an endoluminal intracorporeal endoprosthesis for treating aneurysms and/or stenoses in both arteries and veins comprising the following claim limitations:
(claim 1) A venous stent (as shown in Figs. 3 and 5-7; col. 3, lines 8-15; use in blood vessels including veins expressly disclosed) expandable from a constrained configuration (as shown in Fig. 5) to a deployed configuration (as shown in Figs. 3 and 7) comprising a first vascular stent (120, Fig. 3) composed of a first tubular graft member (128, Fig. 3) and a plurality of first supports (126, Fig. 3) coupled to the tubular graft member (128), a second vascular stent (300a/300b, Fig. 3) configured to (i.e., capable of) be placed at a venous obstruction (col. 3, lines 8-15; expressly capable of being used in veins for treatment of aneurysms and/or stenoses, if one so desires), wherein a diameter of the second vascular stent (300a/300b) is less than a diameter of the first vascular stent (120) (as expressly shown in Fig. 3; i.e., second vascular stent inserted into first vascular stent), the second vascular stent (300a/300b) comprises an anchored end (i.e., “lower” end as shown in Fig. 3) and a fitted end (i.e., “upper” end as shown in Fig. 3), the second vascular stent is composed of a second tubular graft member and a plurality of support second supports (col. 6, lines 5-9; each endoprosthesis stent component comprises both a stent and a cover/envelope to reconstruct a blood vessel), the anchored end (i.e., “lower” end as shown in Fig. 3) comprises the second tubular graft member and the plurality of second supports coupled to the second tubular graft member (col. 6, lines 5-9; each endoprosthesis stent component comprises both a stent and a cover/envelope to reconstruct a blood vessel), and a fitting member (152/154, Fig. 3), fixed on an inner wall of tubular graft member (128) of the first vascular stent (120), wherein a diameter of the fitting member (152/154) is less than that of the first vascular stent (120) (as shown in Figs. 3-4; col. 10. Line 66-col. 11, line 12; fitting member insertion into first vascular stent expressly disclosed), the fitted end (i.e., “upper” end as shown in Fig. 3) is connected into the fitting member (152/154) such that an interior of the first vascular stent (120) is partitioned into an inner passage area (122, Fig. 3) (inner passage segment expressly disclosed) and a fitting area (150, Fig. 3) (fitting segment expressly disclosed);
(claim 2) wherein the first vascular stent and the second vascular stent are self-expansion stent grafts (col. 9, lines 3-10; col. 10, lines 24-28 and 38-42; col. 11, lines 32-34; col. 15, lines 22-25; stent components of the endoprostheses expressly composed of self-expandable shape memory material such as Nitinol);
(claim 3) further comprising a first sheath (430, Figs. 5-7) and a second sheath (col. 16, lines 12-26; sheath expressly used for the second stent 300a/300b), wherein the first sheath (430) is configurated to compress and constrain the first vascular stent (120) and the fitting member (152/154) in constrained configurations against the mandrel (e.g., sheath 430 is fully capable of holding these components in constrained configurations) (as shown in Fig. 5), and the second sheath is configurated to wrap and constrain the second vascular stent (300a/300b) in a constrained configuration against a mandrel (col. 16, lines 12-26; sheath expressly used to constrain and thereafter release the second vascular stent 300a/300b) (e.g., the sheath for the second stent 300a/300b is fully capable of holding these components in a constrained configuration);
(claim 4) wherein a length of the first vascular stent (120) ranges from 20 mm to 70 mm (as shown in Fig. 3; col. 12, lines 54-57; first stent 120 expressly may comprise first segment 122 (30mm), second segment 150 (15mm), and third segment 160 (15mm) totaling an overall stent 120 length of 60mm);
(claim 5) wherein diameters of two ports of the first vascular stent (120) range from 12 mm to 36 mm, respectively (col. 12, lines 46-50; first stent 120 diameters of 20mm to 30mm expressly disclosed);
(claim 6) wherein a length of the second vascular stent (300a/300b) ranges from 40 mm to 160 mm (col. 12, lines 58-64; second stent 300a/300b lengths of 110mm and/or 125mm expressly disclosed);
(claim 7) wherein diameters of two ports of the second vascular stent (300a/300b) range from 8 mm to 22 mm, respectively (col. 12, lines 58-64; second stent 300a/300b diameters of 12mm and/or 14mm expressly disclosed);
(claim 8) wherein the second vascular stent (300a/300b) is in a curved configuration (i.e., curved configuration expressly shown in Fig. 3);
(claims 9 and 10) wherein the plurality of first supports and the plurality of second supports (126) is in the shape of a spiral, a wave, a zigzag, a repeating zigzag, a curved line or a mesh structure (see claims 1 and 16; col. 4, lines 5-22 and 56-58; col. 5, lines 27-30 and 53-57; col. 6, lines 18-20; col. 12, lines 31-35; support 126 of stent 120 and stents of endoprostheses 300a/300b expressly disclosed as mesh structures);
(claim 14) wherein the fitting member (152/154) is a self-expansion stent member (col. 9, lines 3-10; col. 10, lines 24-28 and 38-42; col. 11, lines 32-34; col. 15, lines 22-25; stent components of the endoprostheses expressly composed of self-expandable shape memory material such as Nitinol), a balloon-dilatation stent member (col. 15, lines 63-65; balloon expansion expressly disclosed), or a tubular graft member (as expressly shown in Fig. 3); and
(claim 15) wherein the fitting member (152/154) is a balloon-dilatation stent member (as shown in Figs. 3 and 5-7), and the first vascular stent (120) is equipped with a balloon (450, Figs. 5-7) disposed in and used to expand the fitting member (152/154) (as shown in Figs. 6-7), and the first sheath (430) is configurated to compress and constrain the first vascular stent (120), the fitting member (152/154) and the balloon (430) in constrained configurations against the mandrel (as shown in Fig. 5) (e.g., sheath 430 is fully capable of holding these components in constrained configurations against a mandrel or rod 484).
Robichon, as applied above, discloses an endoluminal intracorporeal endoprosthesis comprising all the limitations of the claim except for the plurality of supports surrounding the tubular graft member of the first and second vascular stents, and the fitted end only comprises the plurality of second supports and is free of the second tubular graft member (i.e., the plurality of supports/mesh is longer than the tubular graft member).
However, Cragg teaches (see Figs. 17D-17E) a similar endoluminal intracorporeal endoprosthesis being formed by a plurality of supports surrounding a tubular graft member. Accordingly, Cragg teaches that it is known that a tubular graft member surrounding a plurality of supports and a plurality of supports surrounding a tubular graft member are elements that are functional equivalents for providing an endoprosthesis that reconstructs/replicates a native blood vessel. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the plurality of supports surrounding a tubular graft member taught by Cragg for the tubular graft member surrounding a plurality of supports of Robichon because both elements were known equivalents for providing an endoprosthesis that reconstructs/replicates a native blood vessel within the endoprosthesis art. The substitution would have resulted in the predictable results of providing an endoprosthesis that reconstructs/replicates a native blood vessel to the Robichon device.
Brightbill further teaches (see Fig. 3) a similar endoprosthesis system (300) for treating stenoses comprising a fitted end (at 231) only comprising the plurality of second supports (310) and is free of the second tubular graft member (312) (i.e., the plurality of supports/mesh is longer than the tubular graft member) in order to beneficially enhance the prevention of restenosis via providing a therapeutic agent on the membrane of an endoprosthesis while further avoiding the possibility of overdosing in the area of stent overlap (see Abstract; col. 1, lines 11-13; col. 1, line 35-col. 2, line 16; col. 2, lines 36-49; col. 3, lines 42-49; col. 4, line 48-col. 5, line 4). 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 Robichon in view of Cragg to have a fitted end only comprising the plurality of second supports and is free of the second tubular graft member in order to beneficially enhance the prevention of restenosis via providing a therapeutic agent on the membrane of an endoprosthesis while further avoiding the possibility of overdosing in the area of stent overlap, as taught by Brightbill.
Regarding claims 13 and 14, Robichon in view of Cragg and Brightbill discloses the claimed invention except for a length of the supports at the fitted end being 1/2 to 1/3 of the total length of the second vascular stent, and/or a length of the fitting member being equal to or less than a length of the first vascular stent. It would have been an obvious matter of design choice to construct the lengths of the fitting member and/or the length of the free supports of the fitting member as claimed, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Robichon in view of Cragg and Brightbill as applied to claim 1 above, and further in view of Quinn (US 6,645,242).
Robichon in view of Cragg and Brightbill, as applied above, discloses an endoluminal intracorporeal endoprosthesis comprising all the limitations of the claim except for wherein the fitting member is a diaphragm member, and two sides of the diaphragm member are respectively fixed on the inner wall of the tubular graft member of the first vascular stent to form a tube shape.
However, Quinn teaches (see at least Figs. 18-22) a similar endoluminal intracorporeal endoprosthesis wherein the fitting member (280, Fig. 21) is a diaphragm member (as shown in Fig. 21), and two sides (at the respective 215 reference numerals in Fig. 21) of the diaphragm member (280) are respectively fixed on the inner wall of the tubular graft member (200) of the first vascular stent to form a tube shape (as expressly shown in Fig. 21). Accordingly, Quinn teaches that it is known that a diaphragm fitting member and a lateral tubular duct fitting member are elements that are functional equivalents for providing a partition with a primary graft sleeve of a bifurcated intravascular stent graft. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the diaphragm fitting member taught by Quinn for the lateral tubular duct fitting member of Robichon because both elements were known equivalents for providing a partition with a primary graft sleeve of a bifurcated intravascular stent graft within the endoprosthesis art. The substitution would have resulted in the predictable results of providing a partition with a primary graft sleeve of a bifurcated intravascular stent graft to the Robichon in view of Cragg and Brighbill device.
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 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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