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 Amendment
The amendment filed 11/26/2025 has been entered:
Claims 1-4, 7-9, 11, 31-39, 41-44, and 47-55 are pending in the present application. Claim 43 is currently amended, claims 5-6, 10, 12-30, 40, and 45-46 are canceled, and claims 49-55 are new. Claims 1-4, 7-9, 11, 31-39, and 41-44, and 47-55 are currently examined on the merits.
Applicant’s amendments have been acknowledged, and overcome each and every objection and 112(b) rejection previously set forth in the non-final office action mailed 8/27/2025. All previous objections and 112(b) rejections have been withdrawn.
Allowable Subject Matter
Claims 49 and 51 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons for Indicating Allowable subject matter
The following is an examiner’s statement of reasons for allowance:
The closest prior art drawn to Jang, fails to show or make obvious the claimed combination of elements, particularly the limitations as set for in claims 49 and 51, which recites features not taught or suggested by the prior art. Jang fails to explicitly teach the distal end of the proximal implant segment comprising one or more anchors that extend towards the proximal end of the implant segment.
While this limitation is found in Tessmer, Tessmer only comprises a single implant segment and thus does not teach a portion of the distal end of the proximal implant segment that is angled with respect to the longitudinal axis of the proximal implant segment. Thus, Tessmer does not teach comprising anchors on this particular portion of the proximal implant segment. Further, the location of the anchors is claimed to a degree of specificity where mere rear arranging of parts would not seem obvious.
Response to Arguments
Applicant’s arguments and amendments filed 6/26/2025, specifically the newly added limitations directed to the anchors of the proximal implant segment, self-expandability, and the arrangement of the ring apices, necessitated a new grounds of rejection. Applicant’s arguments with respect to claims 1 and 33, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Jang is maintained as the primary reference in rejecting the present claims.
Das and Tessmer are introduced as secondary references teaching the newly amended limitations of claim 1, with Tessmer also teaching the newly added limitations of claim 33.
Deaton is being maintained as a secondary reference in the present rejection for disclosing and/or rendering obvious the limitations of claims 6, 7, 38, 40, and 48.
Applicant’s arguments regarding the dependent claims on the same grounds as claims 1 and 33 are similarly moot as claims 1 and 33 remain rejected as set forth below.
Additionally, new claim 48 is rejected under previously uncited portions of Jang, as set forth below.
Applicant's arguments with respect to independent claim 1 have been fully considered but they are not persuasive.
Applicant argues Tessmer does not have a distal implant segment and would not succeed if only one anchor was present.
However, Tessmer is not the primary reference over which Applicant’s invention is deemed unpatentable, nor is Tessmer bodily incorporated.
Applicant also argues there is no need for the implant of Jang to include anchors according to Tessmer as Jang teaches the bridge providing the entire structural stabilization for the first and second stent. However, one of ordinary skill in the art would know that stent anchors provide more than just structural stabilization, but would also perform functions such as maintaining position when implanted.
Applicant argues it is not clear how one of ordinary skill in the art would combine the anchors of Tessmer with Jang and Das as neither Jang nor Das provide teachings in this regard. However, the examiner believes the positioning of the anchors of Tessmer adjacent the vessel wall opening would provide direction to one of skill in the art on where to incorporate said anchors. Subsequently, the exact details of how said anchors are incorporated would be within one of ordinary skill in the art as "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397, per MPEP 2141.03.
Applicant’s arguments regarding independent claim 33 on the same grounds as claim one are similarly found not persuasive.
Applicant's arguments with respect to independent claim 43 have been fully considered but they are not persuasive.
Applicant argues that the linear breaches of Jang may connect a lower end of the first stent to a lower end of the second stent, such that Jang is provided with a degree of flexibility, and that incorporating the connectors of Consigny would reduce the flexibility of said implant relative to the implant of Chang alone. However, nowhere does Jang indicate the flexibility of the implant cannot be changed (or reduced) or that there is required range of flexibility the implant must be in to be suitable. Similarly, Jang and Consigny do not demonstrate a specific degree to which flexibility might change to be outside such a range even if it were to be disclosed.
Applicant's arguments with respect to independent claim 48 have been fully considered but they are not persuasive.
Applicant argues one of ordinary skill in the art would not seek to modify Jang in view of Prabhu as Jang is made as a H-side branch stent and does not require enhanced column strength and longitudinal compressional resistance as there is no teaching in Jang to consider such factors. However, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In creating a combination of references, one of ordinary skill in the art would not expect the reference being modified to recognize its own deficiencies and a need for modification beyond the scope of the inventor’s own disclosure. Further, neither Prabhu nor Jang disclose H-side branch stents of Jang not benefiting from or otherwise being incompatible with having the column strength provided by having aligned apices, particularly as Jang does not set forth any particular parameters for column strength to teach away from a modification with Prabhu.
Applicant’s arguments regarding the dependent claims on at least the same grounds of independent claims one, 33, and 43 are similarly not persuasive as claims one, 33, and 43 remain rejected as set forth below.
Applicant’s arguments regarding new claims 49 and 51 are moot as claims are indicated as containing allowable subject matter.
Applicant’s arguments regarding new claims 50, and 52-55 are moot in view of newly cited portions of the prior art as set forth in the rejections below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-4, 8-9, 11, 31-32, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Jang et al. (US 2012/0116500 A1), in view of Das (US 2009/0132027 A1), and Tessmer et al. (US 2024/0009369 A1).
Regarding claim 1, Jang teaches a system for creating an anastomosis (Figs. 3-6 and 12-13; Abstract describes how the device connects a main and branch vessel) the system comprising:
an endovascular delivery device (best seen in Figs. 3-6 and 12-13 showing stent S); and
an intraluminal implant (balloon 102 in Figs. 12-13), wherein the endovascular delivery device is configured to carry the intraluminal implant in a radially compressed configuration (¶s 62-63 describe how the stent is expanded from a compressed to an expanded state; as seen in Figs. 9a and 9b), the intraluminal implant comprising:
a proximal implant segment (second stent 40) comprising a proximal end and a distal end (the ends being inherent to the segment) and a distal implant segment (first stent 20) connected to the proximal implant segment (bridges 30 described in ¶s 39 and 43);
wherein the distal end of the proximal implant segment is configured to be at an angle relative to the axis of the distal implant segment (best seen in Figs. 4 and 13, stents 20 and 30 are angled relative to one another); and
a side opening between the distal end of the proximal implant segment and a proximal end of the distal implant segment (Figs. 4-6 show how the bridge 30 defines a side opening between stents 20 and 30, such as at length d3 in Fig. 6), wherein a portion of a distal edge of the proximal implant segment is angled with respect to a longitudinal axis of the proximal implant segment and forms a portion of the side opening (best seen in Figs. 4 and 12-13; the distal edge of the proximal segment is angled such that aligns with the distal implant segment and forms a portion of the side opening; Fig. 6 also shows a clear angling at reference numeral 42).
Jang does not explicitly teach the implant being self-expanding, or wherein the distal end of the proximal implant segment comprises one or more anchors that extend towards the proximal end of the proximal implant segment, the one or more anchors configured to anchor against a wall of the artery.
However, Das teaches an endovascular implant (Fig. 1; Abstract, ¶s 6 and 40), thus being in the same field of endeavor, which may be self-expandable, balloon inflated, or a hybrid of both (¶s 8-9). Thus, Das shows that having a self-expanded device is an equivalent structure known in the art. Therefore, because these expanding means were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute self-expanding implant of for the balloon expandable device of Jang.
The combination of Jang and Das still do not explicitly teach the distal end of the proximal implant segment comprises one or more anchors that extend towards the proximal end of the proximal implant segment, the one or more anchors configured to anchor against a wall of the artery.
However, Tessmer teaches an endovascular fistula implant (Figs. 1a and 6; Abstract), thus being in the same field of endeavor, comprising a pair of anchors (14, 16) which curve back towards the proximal end of the device and anchor against the wall of an artery (Fig. 6 show how the anchors curve back towards retriever 18 and anchor against artery A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Jang and Das to comprise the arterial wall anchors of Tessmer. Doing so would thus comprise the proximal implant segment comprising one or more anchors that extend towards the proximal end of the proximal implant segment (as the proximal implant segment of Jang ends right at the vessel wall in the same manner as the device of Tessmer), the one or more anchors configured to anchor against a wall of the artery.
Limitations of the system being for “creating an arteriovenous fistula in an arm of a patient”, the delivery device being configured “for access into the arm of the patient”, the delivery device being configured “to be advanced into a vein, and into an artery adjacent to the vein”, the delivery device being configured “to carry the intraluminal implant in a radially compressed configuration into the arm of the patient”, the proximal implant segment being “releasable from the endovascular delivery device to transform from a radially compressed configuration to a radially expanded configuration in which the proximal implant segment extends at least partially through the vein”, the distal implant segment “being releasable from the endovascular delivery device to transform from a radially compressed configuration to a radially expanded configuration in which the distal implant segment is positioned within the artery, wherein the distal end of the proximal implant segment is configured to be at an angle relative to the axis of the distal implant segment”, and “wherein when the proximal implant segment is in the radially expanded configuration extending at least partially through the vein and the distal implant segment is in the radially expanded configuration within the artery, the proximal implant segment is configured to divert flow from the artery into the vein” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Jang, Das, and Tessmer has all the structure of the device as claimed and is also used to analogously create fistulas between vessels . As such, it is capable of performing the functions as claimed.
Regarding claim 2, limitations of the distal implant segment being configured to “anchor against a wall of the artery” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Jang, Das and Tessmer has all the structure of the device as claimed and is also used to analogously create connections between vessels . As such, it is capable of performing the function of anchoring against the wall of an artery as claimed.
Regarding claim 3, Jang further teaches the distal implant segment comprises a tubular body configured to provide radial support to the vessel (Figs. 4, 7, and 8-9 show the tubular shape; ¶S 16-18 and 39 describe the device as cylindrical i.e. tubular; Abstract and ¶s 14 and 60-61 describe how the vessels are supported by the implant).
Further, limitations of the tubular body being configured to “provide radial support to the artery” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Jang, Das, and Tessmer has all the structure of the device as claimed and is also used to analogously create fistulas between vessels . As such, it is capable of performing the functions of providing radial support to an artery as claimed.
Regarding claim 4, Jang further teaches the proximal implant segment comprises a tubular body configured to engage a wall of a vessel (Figs. 4, 7, and 8-9 show the tubular shape; ¶S 16-18 and 39 describe the device as cylindrical i.e. tubular; Abstract and ¶s 14 and 60-61 describe how the vessels are supported by the implant).
Further, limitations of the tubular body being configured to “radially engage a wall of the vein” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Jang, Das, and Tessmer has all the structure of the device as claimed and is also used to analogously create fistulas between vessels . As such, it is capable of performing the functions of engaging a perforator vein as claimed.
Regarding claim 8, limitations of wherein “when the proximal implant segment is in the radially expanded configuration extending through the vein and the distal implant segment is in the radially expanded configuration within the artery, blood flowing through the artery enters the side opening and (i) flows through the proximal end of the distal implant segment and out a distal end of the distal implant segment, and (ii) flows through the distal end of the proximal implant segment and out the proximal end of the proximal implant segment“ are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Jang, Das, and Tessmer has all the structure of the device as claimed and is also used to analogously create fistulas between vessels . As such, it is capable of performing the blood flow directing functions as claimed.
Regarding claim 9, Jang further discloses the distal end of the proximal implant segment comprises an anastomotic ring (Figs. 8-9 show how distal portion 20 has a ring shaped cross-section and thus the stent portions would comprise an anastomotic ring; Figs. 5 and 7 provide additional perspectives).
Regarding claim 11, Jang further discloses the distal end of the proximal implant segment is connected to the proximal implant segment by at least one connecting strut (Fig. 5 best shows bridges 30 and connecting ends 31/32; ¶ 39).
Regarding claim 31, Jang further discloses an axis of the proximal implant segment is angled with respect to an axis of the distal implant segment to cause the angled portion of the distal edge of the proximal implant segment to become generally parallel with the axis of the distal implant segment (Fig. 13 most clearly shows how the distal edge of the proximal implant segment, extending from marker 43, becomes parallel with the distal implant segment).
Regarding claim 32, Jang further discloses the angled portion of the distal edge of the proximal implant segment extends proximally to an apex of the side opening that is positioned proximally of a distalmost portion of the proximal implant segment (see annotated Fig. 5 below).
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Regarding claim 50, Tessmer further teaches comprising a plurality of distinct anchors (anchors 14 and 16) which extend back towards the proximal end of the device (Fig. 6 shows the anchors 14 and 16 pointing towards the proximal end of implant on the other side of the vessel wall).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Jang and Das to comprise the arterial wall anchors of Tessmer. Doing so would thus comprise said one or more anchors comprising a plurality of anchors that each only extend towards the proximal end of the proximal implant segment. Doing so would be advantageous in anchoring the implant in place in a desired location to form AV fistulas (¶ 24 of Tessmer).
Claims 37 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Jang, Das, and Tessmer, as applied to claim 31 above.
Regarding claim 37, the combination of Jang, Das, and Tessmer does not explicitly state the proximal and distal implant segments comprising a different diameter, perimeter, and/or cross-sectional area when in their radially expanded configurations.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Jang to have the proximal and distal implants comprise a different diameter, perimeter, and/or cross-sectional area when in their radially expanded configurations, 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 Jang, Das, and Tessmer would not operate differently with the claimed relative dimensions between the proximal and distal implants. Further, applicant places no criticality on the range claimed, merely indicating that “some embodiments” may comprise such a configuration (¶ 23 of Applicant’s specification).
Regarding claim 39, in an alternate embodiment, Jang teaches the distal implant segment comprises two or less circumferential rings in a particular embodiment (Fig. 6 shows having only two complete rings extending the full length of the device at markers 22).
Thus, it would have been an obvious matter of design choice to make the portions of the distal segment of whatever form or shape was desired or expedient, such as to segment comprise two or fewer rings. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Also see MPEP 2144.04 (IV)(B) which relates to Changes in Shape. Further, Applicant has placed no criticality on the claimed shape as this feature appears to only be shown in the figures.
Claims 33-36, 41-42, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Jang, in view of Tessmer.
Regarding claim 33, Jang discloses an intraluminal implant for creating an anastomosis in a patient (Figs. 3-6 and 12-13; Abstract describes how the device connects a main and branch vessel) the implant comprising:
a proximal implant segment (second stent 40) comprising a proximal end and a distal end (the ends being inherent to the segment);
a distal implant segment (first stent 20) comprising a proximal end and a distal end (the ends being inherent to the segment) and
a side opening between the distal end of the proximal implant segment and a proximal end of the distal implant segment (Figs. 4-6 show how the bridge 30 defines a side opening between stents 20 and 30, such as at length d3 in Fig. 6), wherein a portion of a distal edge of the proximal implant segment is angled with respect to a longitudinal axis of the proximal implant segment and forms a portion of the side opening (best seen in Figs. 4 and 12-13; the distal edge of the proximal segment is angled such that aligns with the distal implant segment and forms a portion of the side opening; Fig. 6 also shows a clear angling at reference numeral 42).
Jang does not explicitly teach said portion of the distal edge of the proximal implant segment comprises one or more anchors that extend towards the proximal end of the proximal implant segment.
However, Tessmer teaches an endovascular fistula implant (Figs. 1a and 6; Abstract), thus being in the same field of endeavor, comprising a pair of anchors (14, 16) which curve back towards the proximal end of the device and anchor against the wall of an artery (Fig. 6 show how the anchors curve back towards retriever 18 and anchor against artery A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Jang and Das to comprise the arterial wall anchors of Tessmer. Doing so would thus comprise the portion of the distal edge of the proximal implant segment comprises one or more anchors that extend towards the proximal end of the proximal implant segment (as the proximal implant segment of Jang ends right at the vessel wall in the same manner as the device of Tessmer).
Limitations of the implant being for “creating an arteriovenous fistula in a patient”, the proximal implant segment configured “to transform from a radially compressed configuration to a radially expanded configuration”, the distal implant segment configured, and “to transform from a radially compressed configuration to a radially expanded configuration” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Jang has all the structure of the device as claimed and is also used to analogously create fistulas between vessels . As such, it is capable of performing the functions as claimed.
Regarding claim 34, Jang further discloses the proximal end of the distal implant segment is connected to the distal end of the proximal implant segment by at least one connecting strut (Fig. 5 shows connecting struts in the form of bridges 30; ¶ 39).
Regarding claim 35, Jang further discloses the proximal implant segment and the distal implant segment comprises a tubular bodies (Figs. 4, 7, and 8-9 show the tubular shape; ¶S 16-18 and 39 describe the device as cylindrical i.e. tubular).
Regarding claim 36, Jang discloses the length of the proximal implant segment is greater than a longitudinal length of the distal implant segment (best seen in Figs. 6 and 12).
Regarding claim 41, Jang further discloses an axis of the proximal implant segment is angled with respect to an axis of the distal implant segment to cause the angled portion of the distal edge of the proximal implant segment to become generally parallel with the axis of the distal implant segment (Fig. 13 most clearly shows how the distal edge of the proximal implant segment, extending from marker 43, becomes parallel with the distal implant segment).
Regarding claim 42, Jang further discloses the angled portion of the distal edge of the proximal implant segment extends proximally to an apex of the side opening that is positioned proximally of a distalmost portion of the proximal implant segment (see annotated Fig. 5 below).
Regarding claim 52, Tessmer further teaches comprising a plurality of distinct anchors (anchors 14 and 16) which extend back towards the proximal end of the device (Fig. 6 shows the anchors 14 and 16 pointing towards the proximal end of implant on the other side of the vessel wall).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Jang to comprise the arterial wall anchors of Tessmer. Doing so would thus comprise said one or more anchors comprising a plurality of anchors that each only extend towards the proximal end of the proximal implant segment. Doing so would be advantageous in anchoring the implant in place in a desired location to form AV fistulas (¶ 24 of Tessmer).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Jang as applied to claim 33 above, and further in view of Deaton et al. (WO 2021/087294 A1).
Regarding claim 38, Jang does not explicitly disclose one or both of the proximal implant segment and the distal implant segment are covered with a graft material.
However, Deaton teaches a system for creating a fistula (Figs. 17, 20A-H and 51A; Figs. 31A-B and 51A all show arteriovenous fistulas; also see ¶s 485 and 661), thus being in the same field of endeavor, comprising an intraluminal implant (device 5100, Fig. 51A), and further discloses the implant may comprise a graft material (¶ 484).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Jang to comprise the graft covering of Deaton, Doing so would thus comprise one or both of the proximal implant segment and the distal implant segment are covered with a graft material. Doing so would be advantageous as covering the device in this manner can be used to cover collateral vessels and disrupt venous valves (¶ 484 of Deaton), thus providing more direct flow (¶ 649).
Claims 43-44 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Jang, in view of Consigny et al. (US 2015/0289875 A1).
Regarding claim 43, Jang teaches an intraluminal implant for creating an anastomosis in a patient (Figs. 3-6 and 12-13; Abstract describes how the device connects a main and branch vessel) the implant comprising:
a proximal implant segment (second stent 40) comprising a proximal end and a distal end, and a longitudinal axis extending therethrough (the ends and longitudinal axis being inherent to the segment);
a distal implant segment (first stent 20) comprising a proximal end and a distal end, and a longitudinal axis extending therethrough (the ends and longitudinal axis being inherent to the segment);
two connecting struts connecting the distal end of the proximal implant segment and the proximal end of the distal implant segment, a first one of the two connecting struts extending along a first side of the intraluminal implant and a second one of the two connecting struts extends along a second side of the intraluminal implant (Fig. 5 shows several bridges 30),
a side opening between the distal end of the proximal implant segment and the proximal end of the distal implant segment (Figs. 4-6 show how the bridge 30 defines a side opening between stents 20 and 30, such as at length d3 in Fig. 6), the side opening formed by: (1) a portion of the distal end of the proximal implant segment comprising a strut extending from a first side of the intraluminal implant to a proximalmost apex and from the proximalmost apex to a second side of the intraluminal implant, (2) the first one of the two connecting struts, (3) a portion of the proximal end of the distal implant segment, and (4) the second one of the two connecting struts; wherein the proximalmost apex is positioned proximally to a distalmost end of the proximal implant segment (see annotated Fig. 5 below).
Jang does not explicitly teach the first side and the second side of the implant are substantially circumferentially opposite one another.
However, Consigny teaches an intravascular device for forming an AV fistula (Figs. 1F-2B; Abstract), comprising two connecting struts connecting distal and proximal implant segments, such struts extending along first and second sides of the implant, where the first side and second side of the implant is substantially circumferentially opposite one another (connectors 15a and 15b; as can be seen in Fig. 2B, struts 15a and 15b overlay with one other, thus showing how they would be circumferentially opposite one another; ¶ 114 also indicates the connectors 15a and 15b are on opposite sides).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the struts of Jang such that the first and second struts were on first and second sides of the intraluminal implant, the first and second sides of the intralumenal implant being substantially circumferentially opposite one another, as taught by Consigny. Doing so would be advantageous in that the site connectors can be made with more flexible properties to accommodate more elongation with respect to a central connector (¶ 114 of Consigny).
Limitations of the implant being for “creating an arteriovenous fistula in a patient”, the proximal implant segment configured “to transform from a radially compressed configuration to a radially expanded configuration and to extend at least partially through a vein of a patient”, the distal implant segment configured “to transform from a radially compressed configuration to a radially expanded configuration and to extend at least partially through an artery of the patient”, and “wherein when the proximal implant segment is in the radially expanded configuration extending at least partially through the vein and the distal implant segment is in the radially expanded configuration extending through the artery, the proximal implant segment is configured to divert flow from the artery into the vein, and the proximal implant segment is configured to not substantially obstruct a lumen of the artery based at least in the part on the angled portion of the distal edge of the proximal implant segment” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Jang has all the structure of the device as claimed and is also used to analogously create fistulas between vessels . As such, it is capable of performing the functions as claimed (see annotated Fig. 5 below which also shows how the struts extend on both sides of the opening, such as in area 40a).
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Regarding claim 44, Jang further discloses the proximalmost apex forms a bullet-shaped tip (see annotated Fig. 5 above; said apex interpreted as being bullet-shaped).
Regarding claim 53, Consigny further teaches the proximal and distal portions may be connected by one, two, three, four, or a plurality of connecting elements (¶ 23).
Thus, Consigny shows that having two connecting struts is an equivalent structure known in the art. Therefore, because these two connecting struts arrangements were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the three connecting struts of Jang for two connecting struts, as taught by Consigny. Doing so with thus comprise two connecting struts being the only connection between the distal end of the proximal implant segment and the proximal end of the distal implant segment.
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Jang as applied to claim 46 above, and further in view of Deaton.
Regarding claim 47, Jang does not explicitly disclose the proximal implant segment, distal implant segment, and a portion of the intraluminal implant between the two connecting struts and between the proximal and distal implant segments is covered with graft material.
However, Deaton teaches a system for creating a fistula (Figs. 17, 20A-H and 51A; Figs. 31A-B and 51A all show arteriovenous fistulas; also see ¶s 485 and 661), thus being in the same field of endeavor, comprising an intraluminal implant (device 5100, Fig. 51A), and further discloses the implant may be covered by a graft material (¶ 484).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Jang to comprise the graft covering of Deaton. Doing so would thus comprise the device (i.e. the proximal implant segment, distal implant segment, and a portion of the intraluminal implant between the two connecting struts and between the proximal and distal implant segments) being covered by a graft material. Doing so would be advantageous as covering the device in this manner can be used to cover collateral vessels and disrupt venous valves (¶ 484 of Deaton), thus providing more direct flow (¶ 649).
Claims 48 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Jang in view of Prabhu et al. (NPL: Engineering assessment of the longitudinal compression behavior of contemporary coronary stents).
Regarding claim 48, Jang teaches an intraluminal implant for creating an anastomosis in a patient (Figs. 3-6 and 12-13; Abstract describes how the device connects a main and branch vessel) the implant comprising:
a proximal implant segment (second stent 40) comprising a proximal end and a distal end, and a longitudinal axis extending therethrough (the ends and longitudinal axis being inherent to the segment) and a plurality of longitudinally spaced apart rings that extend along a circumference of the proximal implant segment (as seen in Figs. 5 and 6, the tubular, wire frame would comprise a series of rings), each of the plurality of rings of the proximal implant segment comprising a plurality of proximal apices and a plurality of distal apices (the diamond shapes of segment 40 comprise both proximal and distal apices, pointing towards and away from the first stent 20), wherein the proximal implant segment is configured to transform from a radially compressed configuration to a radially expanded configuration (¶s 62-63 describe how the stent is expanded from a compressed to an expanded state; as seen in Figs. 9a and 9b);
a distal implant segment (first stent 20) comprising a proximal end and a distal end, and a longitudinal axis extending therethrough (the ends and longitudinal axis being inherent to the segment); and
a side opening between the distal end of the proximal implant segment and the proximal end of the distal implant segment (Figs. 4-6 show how the bridge 30 defines a side opening between stents 20 and 30, such as at length d3 in Fig. 6), wherein a portion of the distal edge of the proximal implant segment is angled with respect to a longitudinal axis of the proximal implant segment and forms a portion of the side opening (best seen in Figs. 4 and 12-13; the distal edge of the proximal segment is angled such that aligns with the distal implant segment and forms a portion of the side opening; Fig. 6 also shows a clear angling at reference numeral 42).
Jang does not explicitly teach the proximal implant segment having the plurality of proximal apices of the plurality of rings be substantially longitudinally aligned, and the plurality of distal apices of the plurality of rings also being substantially longitudinally aligned, the plurality of proximal apices of the plurality of distal apices being circumferentially offset.
However, Prabhu teaches a series of stent patterns for use with blood vessels (Figs. 2 and 7; Abstract) in which a plurality of proximal apices of a plurality of rings are substantially longitudinally aligned, and the plurality of distal apices of the plurality of rings also being substantially longitudinally aligned, the plurality of proximal apices of the plurality of distal apices being circumferentially offset (Fig. 7 shows In-phase, peak-to-valley configuration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal implant segment to comprise a plurality of proximal apices of the plurality of rings substantially longitudinally aligned, and the plurality of distal apices of the plurality of rings also being substantially longitudinally aligned, the plurality of proximal apices of the plurality of distal apices being circumferentially offset, as taught by Prabhu. Doing so would be advantageous in providing a stent configuration with sufficient column strength and preventing longitudinal compression (as written in Fig. 7 of Prabhu).
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Regarding claim 55, Jang further teaches the plurality of longitudinally spaced apart rings of the proximal implant segment comprise a plurality of spaced apart rings that form a distal portion of the proximal implant segment and a plurality of spaced apart rings that form a proximal portion of the proximal implant segment (as seen in Figs. 5 and 6, the tubular, wire frame would comprise a series of rings; said frame inherently comprising proximal and distal segments which would be comprised of said rings).
The combination of Jang and Prabhu do not explicitly teach the plurality of spaced apart rings that form the distal portion of the proximal implant segment comprise struts each having a first length between proximal and distal apices, wherein said plurality of spaced apart rings that form the proximal portion of the proximal implant segment comprise struts each having a second length between proximal and distal apices, and wherein the second length is greater than the first length.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Jang and Prabdu to have claimed relative lengths 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 Jang and Prabhu would not operate differently with the claimed lengths. Further, Applicant places no criticality on the range claimed (¶s 23 and 71 of Applicant’s specification describes a number of different length configurations may all be suitable).
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Jang in view of Prabhu, as applied to claim 48 above, and further in view of Consigny.
Regarding claim 54, the combination of Jang and Prabhu do not explicitly teach the adjacent rings of the plurality of longitudinally spaced apart rings are connected by no more than two longitudinally oriented struts.
However, Consigny teaches an intravascular device for forming an AV fistula (Figs. 1F-2B; Abstract), comprising multiple configurations of longitudinal connecting struts between rings (Fig. 3A demonstrates an arrangement comprising U crowns, Y crowns, and W crowns; ¶ 31 are the describes how there may be one, two, three, or no crowns in between a set of crowns).
Thus, Consigny shows that having adjacent rings of the plurality of longitudinally spaced apart rings being connected by no more than two longitudinally oriented struts is an equivalent structure known in the art. Therefore, because these two connecting struts arrangements were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the multiple connecting struts of Jang for two connecting struts, as taught by Consigny. Doing so with thus comprise wherein adjacent rings of the plurality of longitudinally spaced apart rings are connected by no more than two longitudinally oriented struts.
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.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781