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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/21/26 has been entered.
Response to Arguments
Applicant's arguments filed 8/27/25 have been fully considered but they are not persuasive. Applicant argues the prior art fails to disclose “a unitary filling body”, specifically Argentine’s hydrogel composition 108 is in association with a graft substrate (paragraph 0029) which is coated on, impregnated in, or co-formed with a graft material. Applicant argues that in these conditions, the hydrogel composition is described as part of the graft structure, rather than as a unitary body arranged in a compressed state as claimed.
However, Examiner notes paragraph 0029 discloses the filling body may be coated on the outer surface of the graft material (not necessarily impregnated into the graft material 110 of the tubular body 104). In this configuration, the graft material may be considered a separate component from the filling body as it is applied on the tubular body either before . Therefore, the filling body 108 itself is a “unitary” body as it is the only portion of the body being considered, which just so happens to surround or be coated around the tubular member. The filling body may be transformed from a compressed to an expanded state (figures 3A, 3B). Additionally, or alternatively, the term “unitary” may be defined as “a: of or relating to a unit; b: based on or characterized by unity or units” and a “unit” may be defined as “a single thing, person, or group that is a constituent of a whole” as indicated by Merriam-Webster Online Dictionary. Therefore, even if interpreted as including the additional graft material 110, which is not necessary, the components would still constitute a whole structure, and may be considered unitary.
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, 2, 3, 8, 10-14, 16, 24, 25 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Argentine et al. 2017/0360993 in view of Wolff et al. US 5545208 and further in view of Wilson et al. US 20050075405.
Regarding claims 1, 11-14, 24, 25 and 26, Argentine et al. discloses a catheter system for delivery of a filling body to an aneurysmal sac in a body lumen (paragraph 0060, figures 1A-6), which the catheter system comprises:
a substantially tubular sheath defining an interior volume (paragraph 0060-0061, methods for carrying out the radial expansion are known in the art and suitably include the use of a balloon catheter, or removal of a covering or sheath to allow endovascular prosthesis to self-expand, as described herein and known in the art)
a unitary filling body (108, 108A) arranged in a compressed state in the interior volume (fig. 3A, 4A; paragraphs 0038, 0062, composition 108 is shown in a pre-insertion state, and expands once delivered)
wherein the unitary filling body (108, 108A) is expandable (paragraph 0007, 0058) when released from the tubular sheath (paragraph 0061, 0062; removal of a covering or sheath to allow expansion once positioned within the body) and is configured to include a substantially cylindrical lumen upon expansion (for example, figures1B, 3B, 4B; lumen 116), the lumen 116 of the unitary filing body is defined by an inner surface of the filing body comprising the same material as rest of the filing body (inner surface of 108 or 108A), wherein the unitary filling body extends to and forms the entire outer surface of the unitary filling body (outer surface of 108, 108A, for example, figures 3A, 3B), the filling body consists of the unitary filling body material (unitary filling body is comprised only of material 108, 108A, figures 3A, 3B, for example).
Argentine et al. discloses removal of a covering or sheath to allow endovascular prosthesis 100 to self-expand (paragraph 0057) from a low profile delivery collapsed configuration (for example, figure 5A) to an expanded configuration (for example, figure 5B; paragraph 0055; Examiner notes that during this expansion, the filling body and the lumen of the filling body are both expanded once deployed from the catheter), but fails to explicitly disclose a substantially tubular shaft having a proximal end, a distal end, and a guidewire lumen extending between the proximal and distal ends; the tubular sheath coaxially positioned over the tubular shaft and slidable relative to the tubular shaft; a unitary filling body arranged in the compressed state in the interior volume between the tubular sheath and the tubular shaft near the distal end of the tubular shaft; wherein a distal portion of the filling body and a distal portion of the lumen of the unitary filling body is configured to expand responsive to translational sliding of the tubular sheath to fill a portion of the aneurysmal sac corresponding to the distal portion of the unitary filling body that is released from the tubular sheath, a length of the distal portion of the filling body and distal portion of the lumen of the unitary filling body that expands is proportional to a distance that the tubular sheath slides; wherein the unitary filling body comprises a porous material that extends to and forms at least a portion of an outer surface of the filling body, wherein the porous material has an open cell structure and a shape memory; and wherein the lumen of the filling body is defined by an inner surface of the filling body, the inner surface consisting of the porous material.
Wolff et al. teaches deploying a similar stent device (figure 18-19c) having a substantially tubular shaft (distal end of balloon catheter 50) with a guidewire lumen (for guidewire 66) extending between a proximal and distal end (figures 19a-19f) and an expandable filling body or stent 58 being covered by a sheath 60 (column 10, lines 62-66), the filling body 58 self-expands in response to translational sliding of the sheath to fill a portion of a blood vessel corresponding to the distal portion that is released from the tubular sheath (column 11, lines 3-13; sheath is retractable, or translationally slidable, to release the stent which will radially expand as sheath is withdrawn, body 58 expands partially within the vessel or configured to be expanded at least partially within the aneurysmal sac in an area between the tubular shaft and a lumen of an aneurysm, if delivered over the aneurysmal sac, corresponding to the retraction of the sheath, figures 19b-19d), the filling body expands proportionally to a distance the tubular sheath slides (as sheath is retracted, the distal portion of stent expands, figure 19b-19c), until the sheath is fully retracted, figure 19d), the distal portion of the filling body and the distal portion of the lumen of the filling body is configured to substantially expanding while the tubular sheath partially covers the tubular shaft (figure 19c), the filling body and the lumen of the filling body is configured to maintain a state where the distal portion is substantially expanded and a proximal portion is compressed (figure 19c) during deployment by controlling the retraction of sheath 60 (sheath is drawn back to allow prosthesis to be expanded and controlled based on the position of the sheath, column 11, lines 10-13).
Wilson et al. discloses wherein the filling body comprises a porous material 105 (paragraph 0037, 0049, open cell structures with pores for making foam structures for high expansibility and low density controlling forces imposed by the device on the aneurysm wall during expansion) that extends to and forms at least a portion of an outer surface of the filling body (figures 1, 2, filling body for filling a structure such as an aneurysm has an inner around guidewire 104 and outer surface facing the aneurysm), wherein the porous material has an open cell structure and a shape memory (paragraph 0037), shape memory foam may comprise an open cell foam with porosity as designed for each individual application (paragraph 0037). It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a porous material comprising an open cell structure and a shape memory for filling an aneurysm, 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.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Argentine with translational sliding or retraction of a sheath for proportionally expanding the filling body, as known in the art and taught by Wolff et al., to retract a sheath to control exposure of a self-expandable filling body once placed at the desired location within the body, and with a filling body being a porous material has an open cell structure and a shape memory, as taught by Wilson et al. to provide a porous shape memory material having high expansibility and low density for controlling imposed forces on the device on the aneurysm wall during expansion, while allowing for expansion to fill the aneurysm shape as required for an individual application.
Regarding claim 2, Argentine further discloses: an outer surface of the filling body is non-cylindrical, and is one of bulbous shaped, ellipsoidal or spheroid (for example, bulbous shape 108A, figure 3B).
Regarding claim 3, Argentine further discloses, wherein a stent is arranged in the lumen of the filling body (figure 3A, 3B, 4C, body stent 106 within lumen of 108, 108A).
Regarding claim 8, Argentine discloses wherein the filling body is coated with a hemostatic coating that promotes aneurysm sac remodeling (filing body may comprise multiple layers, for example, paragraph 0037, 0041; outer layer 204 in figure 4B, the outer layer may comprise a bioactive agent layer, and bioactive agents may include collagen, fibrin, thrombin, other pro-thrombotic material which has an effect on living tissue and may promote remodeling).
Regarding claim 10, Argentine et al. discloses and an outer surface of the filling body having a main dimension perpendicular to the longitudinal axis of the lumen of the filling body (see annotated fig. 3B below) the filling body expandable to fill the aneurysm or the empty volume (paragraph 0033), but fails to explicitly disclose wherein the main dimension is at least 1.5 times a diameter of the lumen of the filling body.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Argentine et al. to have a the main dimension is at least 1.5 times a diameter of the lumen of the filling body 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 relative 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 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Argentine et al. would not operate differently with the main dimension is at least 1.5 times a diameter of the lumen of the filling body and the device would function successfully with the claimed range as required to fill the empty space or aneurysm sac.
Regarding claim 16, Argentine et al. discloses wherein the filling body is configured to fill an aneurysmal sac when the filling body is in the expanded state (paragraph 0081).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Argentine et al. 2017/0360993 in view of Wolff et al. US 5545208 and in view of Wilson et al. US 20050075405 as discussed above, and further in view of Maitland et al. US 2019/0117830.
Regarding claim 5, Argentine in combination with Wolff et al. and Wilson et al. discloses a filling body comprising a porous filling body (Argentine, paragraph 0025, filling material foam 108, 108a; Wilson et al., paragraph 0037, 0049, open cell structures with pores for making foam structures for high expansibility and low density controlling forces imposed by the device on the aneurysm wall during expansion, shape memory foam may comprise an open cell foam with porosity as designed for each individual application), the filling body may be a foam (paragraph 0025), and may be applied by spraying, spin coated, layer, printed, painted or rolled (Argentine, paragraph 0029), but fails to explicitly disclose a non-isotropic 3D printed foam.
Maitland et al. discloses porous shape memory polymer foams (paragraph 0114) which may be tailored with various densities or pore sizes (paragraph 0118), the foams may have an anisotropic morphology (or non-isotropic, paragraph 0123) to provide the desired mechanical and shape memory characteristics. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a porous material comprising an open cell structure and a shape memory for filling an aneurysm, the foam having an anisotropic, or non-isotropic, morphology, 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.
Additionally, the claimed phrase “3D-printed with a structure” is being treated as a product by process limitation. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. 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). Thus, even though Argentine in combination with Wilson et al. and Maitland et al. is silent as to the process used to create a 3D printed foam, it appears that the product being a porous foam as disclosed by Argentine in combination with Wilson et al. and Maitland et al. would be the same or similar as that claimed.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Argentine et al. 2017/0360993, in view of Wolff et al. US 5545208, in view of Wilson et al. US 20050075405 as discussed above, and further in view of Evans et al. 2006/0212112.
Regarding claim 9, Argentine et al. in combination discloses the filling body as claimed, but fails to disclose the lumen of the filling body being flared on at least one ends to facilitate cannulation.
Evans teaches the lumen of the filling body is flared on at least one (proximal end 50, Fig. 5D), to facilitate cannulation (lower or proximal end 50 of the tubular lumen will be flared to a larger diameter so that it can accommodate the openings into both of the iliac arteries, paragraph 52).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the filling body of Argentine in combination to have at least one flared end as taught by Evans for the purpose of accommodating the openings into bifurcation arteries.
Claims 15 and 22 is rejected under 35 U.S.C. 103 as being unpatentable over Argentine et al. 2017/0360993 in view of Wolff et al. US 5545208, in view of Wilson et al. US 20050075405, as discussed above, and further in view Leynov et al. US 2007/0233224.
Regarding claims 15 and 22, Argentine et al. discloses the catheter system essentially as claimed as discussed above wherein when the filling body is configured to be arranged so that there is minimal space in a lateral direction to provide stability to a stent graft fitted in the lumen of the filling body (paragraph 0023, configured may comprise one or more body stents or stent grafts, will be minimal space, as the filling body is placed within a vessel filling an already limited space, further the size or shape of the system may provide for limited space as required for stability), but fails to explicitly disclose the filling body is configured to be deployed in a step-wise procedure wherein the distal portion being deployed first to enable being repositioned, wherein the distal end is in an expanded state and the proximal end is in a compressed state.
Leynov et al. teaches a similar catheter delivery system, comprising a filling body 12 being delivered over an aneurysm 335 (figure 5B), the filing body being partially deployed or partially expanded and then repositionable (paragraph 0023) in order to select a more suitable location or to correct errors in positioning resulting from the partial deployment (paragraph 0046) or to replace with a different size body (paragraph 0046), the partially deployed or expanded body being restricted to movement within the location within the blood vessel lumen (figure 2B, paragraph 0045, may exert force to maintain position within the body lumen 30).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Argentine et al. and Wolff et al. so that the filling body is configured to be deployed in a step-wise procedure by repositioning the filling body even after partial expansion, as taught by Leynov et al. to allow for a more suitable location or to correct for errors in positioning or help maintain positioning within the vessel lumen.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Argentine et al. 2017/0360993 in view of Wolff et al. US 5545208, in view of Wilson et al. US 2005/0075405 as discussed above, and further in view of Roberts et al. US 5603698.
Regarding claims 17-19, Argentine et al. in combination disclose the catheter system essentially as claimed as discussed above, but fails to explicitly disclose the tubular sheath comprising a tapered portion, the tapered portion decreasing in diameter toward the proximal end of the tubular sheath, or the tapered portion being located proximal to the filling body.
Roberts et al. teaches a prosthesis delivery system 2 comprising a retractable sheath 20 having a reduced diameter portion 24 and a distal enlarged portion 22 for covering the stent or prosthesis during entry into the body (column 4, lines 1-5).
Therefore, it would have been obvious to one having ordinary skill in the art to provide a tapered retractable sheath, as taught by Roberts et al. to provide a sheath that is larger at a distal end for carrying the prosthesis, while still having a smaller distal profile.
Conclusion
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/CHRISTINA C LAUER/
Examiner, Art Unit 3771