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 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 6/8/26 has been entered.
Response to Amendment
Claims 1-20 are pending in the application. Claims 18-20 are new.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6, 8, 10, and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Stanfield et al. (US 2017/0202575 A1) (“Stanfield”).
Regarding claim 1, Stanfield discloses (Figures 1-7) an apparatus capable of securing a vascular graft to a blood vessel, the apparatus comprising: a flexible vascular graft (70; paragraph 0035) defining a lumen; and a hub (40) having: a distal end capable of penetrating a blood vessel (Figure 7); a proximal end; a wall extending between the distal end and the proximal end that defines an interior passageway (42); and one or more helical protrusions (44) fixed in relation to the wall and capable of securing the hub relative to the blood vessel, each of the one or more helical protrusions extending away from the interior passageway; wherein a portion (45) of the wall that is disposed between a proximal-most portion of the helical protrusion(s) and a distal-most portion of the helical protrusion(s) tapers in an exterior transverse dimension along a direction from the proximal end of the hub toward the distal end of the hub (paragraph 0035); where the vascular graft (70) is capable of being coupled to the hub such that the lumen of the vascular graft is in communication with the interior passageway of the hub (paragraph 0038). NOTE: the Examiner is interpreting the flexible sheath (70) as a vascular graft. The sheath (70) meets the structural limitations of the claim in that it is flexible and is coupled to the hub such that a lumen of the sheath is in communication with the interior passageway of the hub, and therefore, the sheath is capable of functioning as a vascular graft. The Figures depict securing the hub (40) and sheath (70) to a heart (100), but paragraph 0060 discloses that the device can also be secured to a blood vessel or other body lumen.
Regarding claim 2, Stanfield discloses (Figures 1-7) a penetrator (20) having a distal end capable of penetrating the blood vessel (Figure 6); where the penetrator is disposable through the lumen of the vascular graft (70) and through the interior passageway of the hub such that a portion of the penetrator extends beyond the distal end of the hub (Figure 1).
Regarding claim 3, Stanfield discloses (Figures 1, 6, 7) that the penetrator (20) defines an interior passageway that extends through the distal end of the penetrator and is sized for a guide wire (98).
Regarding claim 4, Stanfield discloses (Figures 1-7) an apparatus capable of securing a vascular graft to a blood vessel, the apparatus comprising: a flexible vascular graft (70; paragraph 0035) defining a lumen; a hub (40) having: a distal end capable of penetrating a blood vessel (Figure 7); a proximal end; a wall extending between the distal end and the proximal end that defines an interior passageway (42); and one or more helical protrusions (44) fixed in relation to the wall and capable of securing the hub relative to the blood vessel, each of the one or more helical protrusions extending away from the interior passageway; and a penetrator (20) having a distal end capable of penetrating the blood vessel (Figure 6), the penetrator defining an interior passageway that extends through the distal end of the penetrator and is sized for a guide wire (98; Figures 1, 6, 7); where the vascular graft (70) is capable of coupling to the hub such that the lumen of the vascular graft is in communication with the interior passageway of the hub, and the penetrator is disposable through the lumen of the vascular graft and through the interior passageway of the hub such that a portion of the penetrator extends beyond the distal end of the hub (Figures 1 and 6). NOTE: the Examiner is interpreting the flexible sheath (70) as a vascular graft. The sheath (70) meets the structural limitations of the claim in that it is flexible and is coupled to the hub such that a lumen of the sheath is in communication with the interior passageway of the hub, and therefore, the sheath is capable of functioning as a vascular graft. The Figures depict securing the hub (40) and sheath (70) to a heart (100), but paragraph 0060 discloses that the device can also be secured to a blood vessel or other body lumen.
Regarding claim 6, Stanfield discloses that the penetrator (20) is couplable to the hub such that rotation of the penetrator rotates the hub (paragraph 0034).
Regarding claim 8, Stanfield discloses (Figure 1) that the proximal end of the hub defines a flange (60). NOTE: chamfer (47) can also be interpreted as a flange.
Regarding claim 10, Stanfield discloses (Figures 1 and 3) that the distal end of the hub (40) has a first transverse dimension (at 45; Figure 3); and the proximal end of the hub has a second transverse dimension (at 60; Figure 1) that is larger than the first transverse dimension.
Regarding claim 12, Stanfield discloses (Figure 3) that the hub (40) is monolithic.
Claims 1, 2, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farnan et al. (US 2013/0060267 A1) (“Farnan”).
Regarding claim 1, Farnan discloses (Figures 1-6B) an apparatus for securing a vascular graft to a blood vessel, the apparatus comprising: a flexible vascular graft (60) defining a lumen (142); and a hub (162) having: a distal end (180) configured to penetrate a blood vessel (Figure 6B); a proximal end; a wall extending between the distal end and the proximal end that defines an interior passageway; and one or more helical protrusions (176) fixed in relation to the wall and configured to secure the hub relative to the blood vessel (paragraphs 0071-0072), each of the one or more helical protrusions extending away from the interior passageway (Figure 6A); wherein a portion of the wall that is disposed between a proximal-most portion of the helical protrusion(s) and a distal-most portion of the helical protrusion(s) tapers in an exterior transverse dimension along a direction from the proximal end of the hub toward the distal end of the hub (Figure 6A shows the distal portion of the wall tapers at the distal-most portion of the helical protrusions); where the vascular graft (60) is configured to be coupled to the hub such that the lumen of the vascular graft is in communication with the interior passageway of the hub (Figures 6A, 6B).
Regarding claim 2, Farnan discloses (Figures 3A-3F) a penetrator (134/150) having a distal end configured to penetrate the blood vessel (paragraphs 0060-0066); where the penetrator is disposable through the lumen of the vascular graft and through the interior passageway of the hub (Figures 3B, 3C) such that a portion of the penetrator extends beyond the distal end of the hub (shown in phantom in Figures 5B, 5C, 6A).
Regarding claim 18, Farnan discloses (Figures 3A-3D) that the distal end of the penetrator (150) is free of helical protrusions.
Regarding claim 20, Farnan discloses (Farnan, Figures 3A-3E) that the distal end of the penetrator (150) defines an exterior surface, wherein the exterior surface is smooth.
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 4 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Farnan et al. (US 2013/0060267 A1) (“Farnan”) in view of Stanfield et al. (US 2017/0202575 A1) (“Stanfield”).
Regarding claim 4, Farnan discloses (Figures 1-6B) an apparatus for securing a vascular graft to a blood vessel, the apparatus comprising: a flexible vascular graft (60) defining a lumen (142); a hub (162) having: a distal end (180) configured to penetrate a blood vessel (Figure 6B); a proximal end; a wall extending between the distal end and the proximal end that defines an interior passageway; and one or more helical protrusions (176) fixed in relation to the wall and configured to secure the hub relative to the blood vessel (paragraph 0071-0072), each of the one or more helical protrusions extending away from the interior passageway (Figure 6A); and a penetrator (150) having a distal end configured to penetrate the blood vessel (paragraphs 0060-0066); where the vascular graft (60) is couplable to the hub (162) such that the lumen of the vascular graft is in communication with the interior passageway of the hub (Figures 6A and 6B), and the penetrator is capable of being disposed through the lumen of the vascular graft and through the interior passageway of the hub such that a portion of the penetrator extends beyond the distal end of the hub (shown in phantom in Figures 5B, 5C, and 6A).
Farnan fails to disclose the penetrator defining an interior passageway that extends through the distal end of the penetrator and is sized for a guide wire.
In the same field of endeavor, Stanfield teaches (Figures 1, 6, 7) a penetrator (20) defining an interior passageway that extends through the distal end of the penetrator and is sized for a guide wire (98).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the penetrator disclosed by Farnan to include an interior passageway that extends through the distal end of the penetrator and is sized for a guide wire, as taught by Stanfield. This modification would provide passage through the heart/vessel tissue and into the ventricle to provide access to the tissue surface (Stanfield, paragraph 0049).
Regarding claim 19, Farnan as modified by Stanfield teaches (Farnan, Figures 3A-3D) that the distal end of the penetrator (150) is free of helical protrusions.
Claims 5, 9, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Stanfield et al. (US 2017/0202575 A1) (“Stanfield”) in view of Farnan et al. (US 2013/0060267 A1) (“Farnan”).
Regarding claim 5, Stanfield discloses the invention substantially as claimed. Stanfield discloses that the vascular graft is attached to the hub via a lock ring (paragraph 0038). However, Stanfield fails to explicitly disclose that the vascular graft is non-removably coupled to the hub. Stanfield further fails to disclose that the vascular graft has a length that is at least 14 centimeters (cm).
Farnan teaches (Figures 1-6B) an apparatus capable of securing a vascular graft/flexible tube to a blood vessel, the apparatus comprising: a vascular graft/flexible tube (60) defining a lumen; and a hub (160, 162; Figure 6B) having: a distal end (180) capable of penetrating a blood vessel; a proximal end (portion of device proximal to the body tissue 74); a wall (178) extending between the distal end and the proximal end that defines an interior passageway (Figures 6A and 6B); and one or more helical protrusions (176) fixed in relation to the wall and capable of securing the hub relative to the blood vessel, each of the one or more helical protrusions extending away from the interior passageway; where the vascular graft/flexible tube is configured to be non-removably coupled to the hub via barbs (92; paragraph 0054) such that the lumen of the vascular graft/flexible tube is in communication with the interior passageway of the hub.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute a barbed, non-removable connection between the graft and the hub, as taught by Farnan, for the lock ring connection disclosed by Stanfield. Farnan shows that a barbed, non-removable connection is an equivalent structure known in the art for attaching a vascular graft/flexible tube to a hub. Therefore, because these two connections were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute a barbed, non-removable connection between the vascular graft/flexible tube and the hub for the lock ring connection between the vascular graft/flexible tube and the hub. Substitution of one known element (barbed, non-removable connection) for another element (lock ring connection) providing the same function to yield predictable results (attaching a vascular graft/flexible tube to a hub) would have been obvious to one of ordinary skill in the art at the time of the invention.
It also would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the vascular graft/flexible tube taught by Stanfield in view of Farnan to have a length that is at least 14 centimeters (cm), since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the vascular graft/flexible tube of Stanfield in view of Farnan would not operate differently with the claimed length. Further, Applicant places no criticality on the range claimed (14 cm or greater), indicating simply that: “The vascular graft may be flexible. Respective vascular grafts (e.g., 14) of the present apparatuses (e.g., 10a) may comprise any suitable vascular graft, such as, for example, a vascular graft having a length from 14 centimeters (cm) to 140 cm (and including every integer and half-integer between 14 and 140 cm), having a lumen (e.g., 18) diameter from 3 millimeters (mm) to 14 mm (and including every integer and tenth of an integer between 3 and 14 mm), and comprising any suitable material, such as, for example, woven polyester, expanded polytetrafluoroethylene, polyethylene terephthalate, and/or the like.” See paragraph 0041 of the specification.
Regarding claim 9, Stanfield discloses the invention substantially as claimed. Stanfield discloses that the flange (60) is a sewing ring (paragraphs 0035-0036). However, Stanfield fails to explicitly disclose that the flange defines one or more openings, each configured to receive a suture.
Farnan teaches (Figures 1-6B) an apparatus capable of securing a vascular graft/flexible tube to a blood vessel, the apparatus comprising: a vascular graft/flexible tube (60) defining a lumen; and a hub (160, 162; Figure 6B) having: a distal end (180) capable of penetrating a blood vessel; a proximal end (portion of device proximal to the body tissue 74); a wall (178) extending between the distal end and the proximal end that defines an interior passageway (Figures 6A and 6B); and one or more helical protrusions (176) fixed in relation to the wall and capable of securing the hub relative to the blood vessel, each of the one or more helical protrusions extending away from the interior passageway; where the vascular graft/flexible tube is configured to be coupled to the hub (via barbs 92) such that the lumen of the vascular graft/flexible tube is in communication with the interior passageway of the hub. Farnan teaches that (Figure 6B) that the proximal end of the hub defines a flange (160), and the flange defines one or more openings (184) capable of receiving a suture (171, 182, 188). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flange disclosed by Stanfield to define one or more openings, each configured to receive a suture, as taught by Farnan. This modification would permit sewing of the hub to secure the hub to a blood vessel via a suture and would resist undesired motion post-operation (Farnan, paragraph 0073).
Regarding claim 13, Stanfield discloses the invention substantially as claimed. Stanfield discloses that the vascular graft/flexible tube is attached to the hub via a lock ring (paragraph 0038). However, Stanfield fails to explicitly disclose that the vascular graft/flexible tube is coupled to the hub such that at least a portion of the hub is received within the lumen of the vascular graft/flexible tube.
Farnan teaches (Figures 1-6B) an apparatus capable of securing a vascular graft to a blood vessel, the apparatus comprising: a vascular graft/flexible tube (60) defining a lumen; and a hub (160, 162; Figure 6B) having: a distal end (180) capable of penetrating a blood vessel; a proximal end (portion of device proximal to the body tissue 74); a wall (178) extending between the distal end and the proximal end that defines an interior passageway (Figures 6A and 6B); and one or more helical protrusions (176) fixed in relation to the wall and capable of securing the hub relative to the blood vessel, each of the one or more helical protrusions extending away from the interior passageway; where the vascular graft/flexible tube is configured to be non-removably coupled to the hub via barbs (92; paragraph 0054) such that at least a portion of the hub is received within the lumen of the vascular graft/flexible tube (Figure 4C) and the lumen of the vascular graft/flexible tube is in communication with the interior passageway of the hub.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute a barbed, non-removable connection where the vascular graft/flexible tube is coupled to the hub such that at least a portion of the hub is received within the lumen of the vascular graft/flexible tube, as taught by Farnan, for the lock ring connection disclosed by Stanfield. Farnan shows that this connection is an equivalent structure known in the art for attaching a vascular graft/flexible tube to a hub. Therefore, because these two connections were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute a barbed, non-removable connection such that a portion of the hub is received within the lumen of the vascular graft/flexible tube for the lock ring connection between the vascular graft/flexible tube and the hub. Substitution of one known element (connection taught by Farnan) for another element (lock ring connection) providing the same function to yield predictable results (attaching a vascular graft/flexible tube to a hub) would have been obvious to one of ordinary skill in the art at the time of the invention.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Stanfield et al. (US 2017/0202575 A1) (“Stanfield”) in view of Justin (US 2001/0037113 A1).
Regarding claim 7, Stanfield discloses the invention substantially as claimed. However, Stanfield fails to disclose that for each of the one or more helical protrusions, a longitudinal distance between adjacent portions of the helical protrusion decreases along a direction from the distal end of the hub to the proximal end of the hub.
Justin teaches (Figures 1-3D) an analogous apparatus comprising a hub (20) having a distal end (23); a proximal end (22); a wall (21) extending between the distal end and the proximal end that defines an interior passageway (44); and a helical protrusion (26) fixed in relation to the wall and configured to secure the hub, the helical protrusion extending away from the interior passageway. Justin teaches that a longitudinal distance between adjacent portions of the helical protrusion decreases along a direction from the distal end of the hub to the proximal end of the hub (paragraph 0030).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the helical protrusion disclosed by Stanfield such that a longitudinal distance between adjacent portions of the helical protrusion decreases along a direction from the distal end of the hub to the proximal end of the hub, as taught by Justin. This modification would provide a helical protrusion that resists an axial force from pulling the hub out of the tissue (Justin, paragraphs 0016, 0030, 0031).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Stanfield et al. (US 2017/0202575 A1) (“Stanfield”) in view of Nash et al. (US 6,030,395) (“Nash”).
Regarding claim 11, Stanfield discloses the invention substantially as claimed. However, Stanfield fails to disclose that the interior passageway of the hub tapers in a transverse dimension along a direction from the proximal end of the hub to the distal end of the hub.
Nash teaches (Figures 1-11) an apparatus for securing a vascular graft/flexible tube (12) to a blood vessel (10), the apparatus comprising: a vascular graft/flexible tube (12) defining a lumen; and a hub (22) having: a distal end (28) configured to penetrate a blood vessel; a proximal end (30); a wall extending between the distal end and the proximal end that defines an interior passageway (32); and one or more annular recesses (48) fixed in relation to the wall and configured to secure the hub relative to the blood vessel; wherein the vascular graft/flexible tube is configured to be coupled to the hub such that the lumen of the vascular graft/flexible tube is in communication with the interior passageway of the hub. Nash teaches that the interior passageway of the hub tapers in a transverse dimension along a direction from the proximal end of the hub to the distal end of the hub (Column 6, lines 11-20).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the interior passageway of the hub to taper in a transverse dimension along a direction from the proximal end of the hub to the distal end of the hub, as taught by Nash. This modification would reduce turbulent flow from the vascular graft/flexible tube to a blood vessel (Nash, Column 6, lines 11-20).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Stanfield et al. (US 2017/0202575 A1) (“Stanfield”) in view of Gartner et al. (US 2015/0038999 A1) (“Gartner”).
Regarding claim 14, Stanfield discloses the invention substantially as claimed. Stanfield discloses that the vascular graft/flexible tube is attached to the hub via a lock ring (paragraph 0038). However, Stanfield fails to disclose a crimped connection between the vascular graft/flexible tube and the hub.
Gartner teaches (Figures 1A-3C) an alternate means of connecting a vascular graft segment/flexible tube (130) to a hub (140) comprising a crimped connection (paragraph 0042).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute a crimped connection between the vascular graft/flexible tube and the hub, as taught by Gartner, for the lock ring connection disclosed by Stanfield. Gartner shows that a crimped connection is an equivalent structure known in the art for attaching a vascular graft/flexible tube to a hub. Therefore, because these two connections were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute a crimped connection between the vascular graft/flexible tube and the hub for the lock ring connection between the vascular graft/flexible tube and the hub. Substitution of one known element (crimped connection) for another element (lock ring connection) providing the same function to yield predictable results (attaching a vascular graft/flexible tube to a hub) would have been obvious to one of ordinary skill in the art at the time of the invention.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Stanfield et al. (US 2017/0202575 A1) (“Stanfield”) in view of Gittings et al. (US 2001/0004699 A1) (“Gittings”).
Regarding claim 15, Stanfield discloses the invention substantially as claimed. Stanfield discloses that the vascular graft/flexible tube is attached to the hub via a lock ring (paragraph 0038). However, Stanfield fails to disclose a welded connection between the vascular graft/flexible tube and the hub.
Gittings teaches an alternate means of connecting a vascular graft segment/flexible tube (18) to a hub (20) comprising a welded connection (paragraph 0064).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute a welded connection between the vascular graft/flexible tube and the hub, as taught by Gittings, for the lock ring connection disclosed by Stanfield. Gittings shows that a welded connection is an equivalent structure known in the art for attaching a vascular graft/flexible tube to a hub. Therefore, because these two connections were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute a welded connection between the vascular graft/flexible tube and the hub for the lock ring connection between the vascular graft and the hub. Substitution of one known element (welded connection) for another element (lock ring connection) providing the same function to yield predictable results (attaching a vascular graft/flexible tube to a hub) would have been obvious to one of ordinary skill in the art at the time of the invention.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Stanfield et al. (US 2017/0202575 A1) (“Stanfield”) in view of Blatter (US 2003/0014064 A1).
Regarding claim 16, Stanfield discloses the invention substantially as claimed. However, Stanfield fails to disclose that the vascular graft/flexible tube comprises at least one of: woven polyester and expanded polytetrafluoroethylene. Stanfield also fails to disclose that the vascular graft/flexible tube has a length that is at least 14 cm.
Blatter teaches (Figures 1-21) a vascular anastomosis device and procedure. Blatter teaches that anastomotic material typically includes autologous material, but it can also include heterologous material or synthetic material. An autologous graft is a graft in which the donor and recipient areas are in the same individual. Heterologous material is derived from an animal of a different species. The graft can be made of a synthetic material such as expanded polytetrafluoroethylene (paragraph 0013).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the vascular graft/flexible tube disclosed by Stanfield to be a vascular graft/flexible tube comprising expanded polytetrafluoroethylene, as taught by Blatter. Blatter teaches that the selection of synthetic materials (such as ePTFE), autologous materials, or heterologous material as graft material was known in the art before the effective filing date of the claimed invention and 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.
It also would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the vascular graft/flexible tube taught by Stanfield in view of Blatter to have a length that is at least 14 centimeters (cm), since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the vascular graft/flexible tube of Stanfield in view of Blatter would not operate differently with the claimed length. Further, Applicant places no criticality on the range claimed (14 cm or greater), indicating simply that: “The vascular graft may be flexible. Respective vascular grafts (e.g., 14) of the present apparatuses (e.g., 10a) may comprise any suitable vascular graft, such as, for example, a vascular graft having a10 length from 14 centimeters (cm) to 140 cm (and including every integer and half-integer between 14 and 140 cm), having a lumen (e.g., 18) diameter from 3 millimeters (mm) to 14 mm (and including every integer and tenth of an integer between 3 and 14 mm), and comprising any suitable material, such as, for example, woven polyester, expanded polytetrafluoroethylene, polyethylene terephthalate, and/or the like.” See paragraph 0041 of the specification.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Farnan et al. (US 2013/0060267 A1) (“Farnan”) in view of Porter et al. (US 2006/0064159 A1) (“Porter”).
Regarding claim 17, Farnan discloses that the vascular graft (60) may include a reinforcing structure to reduce the likelihood of kinking (paragraphs 0047 and 0049). However, Farnan fails to explicitly disclose the vascular graft includes a plurality of ribs.
Porter teaches (Figure 17) a vascular graft that includes a plurality of ribs (120) that provide strain relief to the graft (paragraph 0108).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the vascular graft disclosed by Farnan to include a plurality of ribs, as taught by Porter. This modification would provide strain relief to the graft (Porter, paragraph 0108) and the disclosed reinforcement of Farnan to prevent kink formation (Farnan, paragraph 0047).
Response to Arguments
Applicant's arguments filed 6/8/26 regarding the interpretation of the Stanfield et al. reference have been fully considered but they are not persuasive.
The declaration under 37 CFR 1.132 filed 6/8/26 is insufficient to overcome the rejection of claims 1-16, based upon the interpretation of the Stanfield reference as set forth in the last Office action because: the facts presented are not germane to the rejection at issue and the showing is not commensurate in scope with the claims.
The Applicant has argued that vascular grafts come along with certain structural requirements, e.g., relating to flexibility and length to mimic a blood vessel, as well as material requirements to mitigate potential adverse reactions by the patient’s body to the vascular graft. The Applicant has argued that Stanfield’s flexible sheath is not a vascular graft because:
Stanfield’s sheath is too rigid (pages 3-5 of declaration, pages 10-11 of the response)
Stanfield’s sheath is too short (pages 5-6 of declaration, pages 12-13 of the response)
The functions of Stanfield’s sheath are inconsistent with those of a vascular graft (pages 6-8 of the declaration, pages 13-15 of the response)
The material of Stanfield’s sheath is not suitable for a vascular graft (pages 8-9, pages 15-16 of the response).
The Examiner respectfully disagrees with the arguments presented because they are not germane to the rejection at issue and the showing is not commensurate with the scope of the claims. Claims 1 and 4 only require “a flexible vascular graft defining a lumen” (claims 1 and 4), “the vascular graft is configured to be coupled to the hub such that the lumen of the vascular graft is in communication with the interior passageway of the hub” (claim 1), and “the vascular graft is couplable to the hub such that the lumen of the vascular graft is in communication with the interior passageway of the hub, and the penetrator is disposable through the lumen of the vascular graft and through the interior passageway of the hub such that a portion of the penetrator extends beyond the distal end of the hub” (claim 4). The sheath disclosed by Stanfield is flexible, as claimed, and configured to be coupled to the hub in the manner recited in claims 1 and 4. Applicant’s arguments regarding the rigidity, length, functions, and material of the sheath disclosed by Stanfield are not commensurate with the current scope of the claims. The features that the Applicant is arguing are not recited in claims 1 and 4.
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies (i.e., rigidity, length, material, etc.) are not recited in claims 1 and 4. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The Stanfield reference discloses the structural limitations recited in the claims as currently written.
In response to Applicant's argument that the sheath of Stanfield is not a vascular graft, 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. The claims as currently presented are not structurally different than the sheath disclosed by Stanfield.
Applicant’s arguments, see pages 18-22 of the response, filed 6/8/26, with respect to the rejection(s) of claim(s) 1, 4, and 17 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the previously cited Farnan et al. (US 2013/0060267 A1) reference.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Vassiliadies et al. (US 2008/0269662 A1) disclose (Figures 1-7) a similar apparatus for securing a vascular graft to a blood vessel (Figure 5G).
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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