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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/26/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendments filed on 01/02/2026 has been entered. Claims 1, 12, 21, 22, 23, 30, and 31 have been amended; claims 2-10, and 15-20 have been cancelled. Accordingly, claims 1, 11-14, and 21-34 are pending and under consideration.
Response to Arguments
Applicant’s arguments on filed 01/02/2026, with respect to the rejection(s) of claim(s) 1, 23, and 31 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 Therefore, the rejection has been withdrawn.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 Evard et al. US 6,616,675 B1 (newly cited), as cited in the IDS, in view of McGuckin et al. US 6,695,878 B2 (previously cited), as cited in the IDS, necessitated by amendment.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 11-14, 21-34 are rejected under 35 U.S.C. 103 as being unpatentable over Evard et al. US 6,616,675 B1 (newly cited, hereinafter Evard), as cited in the IDS, in view of McGuckin et al. US 6,695,878 B2 (previously cited, hereinafter McGuckin), as cited in the IDS.
Regarding claim 1, Evard discloses a shunt 10/10e’ (Fig. 1 and Fig. 6’ – connector apparatus 10/10e’; Fig. 6 depicts a sub-variety of connector apparatus 10) for allowing blood flow through a tissue wall (Fig. 1, and Col. 4, line 11-17 – “two adjacently positioned blood vessels having a blood flow passageway formed therebetween, and a connector apparatus of the present invention implanted within such blood flow passageway to facilitate and maintain the desired side-to-side connection between the blood vessels”), the shunt 10e’ (Fig. 6’) comprising:
a central flow portion 40’+42’ (Fig. 6’ – first and second tubular member 40’, 42’) sized to fit at least partially within an opening O (see annotated Fig. 1 below) in a tissue wall TS (see annotated Fig. 1 below – connector apparatus 10 fits within the annotated opening O of tissue wall TS), wherein the tissue wall TS (see annotated Fig. 1 below) is situated between a first anatomical chamber BV1 (Fig. 1 – blood vessel 1) and a second anatomical chamber BV2 (Fig. 1 – blood vessel 2), and the opening O (see annotated Fig. 1 below) forms and maintains a blood flow path between the first anatomical chamber BV1 and the second anatomical chamber BV2 (see annotated Fig. 1 below, and Col. 8, line 20-26 – “FIG. 1 provides a general showing of the manner in which the connector apparatus 10 of the present invention is implanted or installed within openings formed in adjacent blood vessels BV1, BV2 to maintain side-by-side connection and direct alignment of the side wall openings formed in the blood vessel BV1, BV2 ”) and
a first set of one anchoring arm 44’ (Fig. 6’, and Col. 14, line 46-47 – “engagement flange 44’”) coupled at the respective bases thereof to the central flow portion 40’+42’ (Fig. 6’ – flange 44’ is coupled to the top base of tubular member 40’) extending from the central flow portion 40’+42’ (Fig. 6’) at a first end of the central flow portion 40’+42’ (Fig. 6’ – flange 44’ extends from the first tubular member 40’) and adapted to anchor to a first side of the tissue wall TS (see annotated Fig. 1 below, Fig. 6’, and Col. 14, line 46-50 – “the engagement flanges, 44', 46' are held in spaced-apart relation such that the distance there between will cause the flanges 44', 46' to be in abutting contact with the respective luminal surfaces of the first and second passageways or blood vessels BV.sub.1, BV.sub.2”; Examiner contends that flange 44’ will engage and anchor the top side of the annotated tissue wall TS); and
a second set of one anchoring arm 46’ (Fig. 6’, and Col. 14, line 46-47 – “engagement flange 46’”) coupled at the respective bases thereof to the central flow portion 40’+42’ (Fig. 6’ – flange 46’ is coupled to the bottom base of tubular member 42’) extending from the central flow portion 40’+42’ (Fig. 6’) at a second end of the central flow portion 40’+42’ (Fig. 6’ – flange 46’ extends from the second tubular member 42’) and adapted to anchor to a second side of the tissue wall TS (see annotated Fig. 1 below, Fig. 6’, and Col. 14, line 46-50 – “the engagement flanges, 44', 46' are held in spaced-apart relation such that the distance there between will cause the flanges 44', 46' to be in abutting contact with the respective luminal surfaces of the first and second passageways or blood vessels BV.sub.1, BV.sub.2”; Examiner contends that flange 46’ will engage and anchor the bottom side of the annotated tissue wall TS);
wherein the central flow portion 40’+42’ (Fig. 6’) is adapted to:
extend from the first anatomical chamber BV1 (Fig. 1) to the second anatomical chamber BV2 (Fig. 1, and Col. 14, line 46-51 – “such that the engagement flanges, 44', 46' are held in spaced-apart relation such that the distance there between will cause the flanges 44', 46' to be in abutting contact with the respective luminal surfaces of the first and second passageways or blood vessels BV.sub.1, BV.sub.2”) to prevent in-growth of tissue within the opening O (see annotated Fig. 1 below, and Col. 7, paragraph numbered 13 – “The connector apparatus may be constructed with varying amounts of structural support or scaffolding, or may incorporate intraluminally placed structural or non-structural elements which will retard or restrain neointimal growth or natural closure or narrowing of the passageway”), and
expand uni-directionally with the tissue wall TS (see annotated Fig. 1 below, and Col. 20, line 13-25 discusses the longitudinal advancement of first tubular member 40’ within the second tubular member 42’ so that the engagement flanges can extend and make contact with the luminal surfaces) to increase a distance between the bases of the first set of one or more anchoring arms 44’ (Fig. 6’) and the bases of the second set of one or more anchoring arms 46’ (Fig. 6’, and Col. 14, line 46-51 – “such that the engagement flanges, 44', 46' are held in spaced-apart relation such that the distance there between will cause the flanges 44', 46' to be in abutting contact with the respective luminal surfaces of the first and second passageways or blood vessels BV.sub.1, BV.sub.2”).
PNG
media_image1.png
546
737
media_image1.png
Greyscale
Annotated Fig. 1 of Evard
However, Evard does not disclose a first set and second set of anchoring arm adapted to penetrate to a first and second side of the tissue wall, and the central flow portion expands uni-directionally in response to growth of the tissue wall.
Evard, in another embodiment, teaches that while the connector apparatus 10 can have a fixed length, e.g. connector apparatus 10e’ has a fixed length (Col. 14, line 44-46), many, if not all, of the embodiments may be alternatively constructed such that the connecting portion of the connector apparatus is adjustable, telescoping, distendable to accommodate or conform to passageways of differing length (Col. 20, line 13-25 – “Alternatively, many if not all of the embodiments of the present invention may be constructed such that the connecting portion of the connector apparatus 10 is elastic, adjustable, telescoping, distendable, of according configuration, or otherwise adjustable to accommodate or conform to passageways of differing length”).
McGuckin, in the same field of endeavor of intravascular device (Col. 2, line 23), teaches a first set 112, 110 (Fig. 9A – top engaging member 110 and 112) and second set of anchoring arm 112, 110 (Fig. 9A – bottom engaging member 110 and 112) to penetrate to a first and second side of the tissue wall (Fig. 9A – engagement members 110 and 112 penetrate a top side and a bottom side of vessel V).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shunt of Evard to be adjustable, telescoping, and distendable, also as taught by Evard, in order to allow the device to accommodate or conform to the opening of differing length (Col. 20, line 24-26 of Evard). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have come to the conclusion that in response to growth of the tissue wall (see annotated Fig. 1 of Evard), the central flow portion 40’, 42’ would ultimately expand and lengthen since the modified device has the capability of conforming to the length of the passageway. Thus, the limitation “the central flow portion expands in response to growth of the tissue wall” is met.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the engagement mechanism of Evard that allows the device to anchor to the tissue wall, for the hook mechanism of McGuckin since these anchoring mechanisms perform the same function of providing attachment of the implant device to the vascular chambers. Simply substituting one anchoring means for another would yield the predicable result of allowing an implant device to anchor to the tissue wall. See MPEP 2143.
Regarding claim 23, Evard discloses a shunt for allowing blood flow through a tissue wall, the shunt 10/10e’ (Fig. 1 and Fig. 6’ – connector apparatus 10/10e’; Fig. 6 depicts a sub-variety of connector apparatus 10) comprising:
a central flow portion 40’+42’ (Fig. 6’ – first and second tubular member 40’, 42’) sized to pass through an opening O (see annotated Fig. 1 above) in a tissue wall TS (see annotated Fig. 1 above – connector apparatus 10 fits within the annotated opening O of tissue wall TS) to form a blood flow path through the tissue wall TS (see annotated Fig. 1 above, and Col. 8, line 20-26 – “FIG. 1 provides a general showing of the manner in which the connector apparatus 10 of the present invention is implanted or installed within openings formed in adjacent blood vessels BV1, BV2 to maintain side-by-side connection and direct alignment of the side wall openings formed in the blood vessel BV1, BV2 ”);
a first set of one or more anchoring arms 44’ (Fig. 6’, and Col. 14, line 46-47 – “engagement flange 44’”) extending from the central flow portion 40’+42’ (Fig. 6’) at a first end of the central flow portion 40’+42’ (Fig. 6’ – flange 44’ extends from the first tubular member 40’) to anchor to a first side of the tissue wall TS (see annotated Fig. 1 above, Fig. 6’, and Col. 14, line 46-50 – “the engagement flanges, 44', 46' are held in spaced-apart relation such that the distance there between will cause the flanges 44', 46' to be in abutting contact with the respective luminal surfaces of the first and second passageways or blood vessels BV.sub.1, BV.sub.2”; Examiner contends that flange 44’ will engage and anchor the top side of the annotated tissue wall TS); and
a second set of one or more anchoring arms 46’ (Fig. 6’, and Col. 14, line 46-47 – “engagement flange 46’”) extending from the central flow portion 40’+42’ (Fig. 6’) at a second end of the central flow portion 40’+42’ (Fig. 6’ – flange 46’ extends from the second tubular member 42’) to anchor to a second side of the tissue wall TS (see annotated Fig. 1 above, Fig. 6’, and Col. 14, line 46-50 – “the engagement flanges, 44', 46' are held in spaced-apart relation such that the distance there between will cause the flanges 44', 46' to be in abutting contact with the respective luminal surfaces of the first and second passageways or blood vessels BV.sub.1, BV.sub.2”; Examiner contends that flange 46’ will engage and anchor the bottom side of the annotated tissue wall TS).
However, Evard does not disclose wherein the central flow portion is adapted to expand with the tissue wall and in response to growth of the tissue wall without affecting flow through the blood flow path, a first set and second set of anchoring arm adapted to embed into a first and second side of the tissue wall.
Evard, in another embodiment, teaches that while the connector apparatus 10 can have a fixed length, e.g. connector apparatus 10e’ has a fixed length (Col. 14, line 44-46), many, if not all, of the embodiments may be alternatively constructed such that the connecting portion of the connector apparatus is adjustable, telescoping, distendable to accommodate or conform to passageways of differing length (Col. 20, line 13-25 – “Alternatively, many if not all of the embodiments of the present invention may be constructed such that the connecting portion of the connector apparatus 10 is elastic, adjustable, telescoping, distendable, of according configuration, or otherwise adjustable to accommodate or conform to passageways of differing length”).
McGuckin, in the same field of endeavor of intravascular device (Col. 2, line 23), teaches a first set 112, 110 (Fig. 9A – top engaging member 110 and 112) and second set of anchoring arm 112, 110 (Fig. 9A – bottom engaging member 110 and 112) to embed into a first and second side of the tissue wall (Fig. 9A – engagement members 110 and 112 penetrate a top side and a bottom side of vessel V).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shunt of Evard to be adjustable, telescoping, and distendable, also as taught by Evard, in order to allow the device to accommodate or conform to the opening of differing length (Col. 20, line 24-26 of Evard). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have come to the conclusion that in response to growth of the tissue wall (see annotated Fig. 1 of Evard), the central flow portion 40’, 42’ would ultimately expand and lengthen since the modified device has the capability of conforming to the length of the passageway. Thus, the limitation “wherein the central flow portion is adapted to expand with the tissue wall and in response to growth of the tissue wall without affecting flow through the blood flow path” is met.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the engagement mechanism of Evard that allows the device to anchor to the tissue wall, for the hook mechanism of McGuckin since these anchoring mechanisms perform the same function of providing attachment of the implant device to the vascular chambers. Simply substituting one anchoring means for another would yield the predicable result of allowing an implant device to anchor to the tissue wall. See MPEP 2143.
Regarding claim 30, Evard discloses a shunt 10/10e’ (Fig. 1 and Fig. 6’ – connector apparatus 10/10e’; Fig. 6 depicts a sub-variety of connector apparatus 10) for allowing blood flow through a tissue wall (Fig. 1, and Col. 4, line 11-17 – “two adjacently positioned blood vessels having a blood flow passageway formed therebetween, and a connector apparatus of the present invention implanted within such blood flow passageway to facilitate and maintain the desired side-to-side connection between the blood vessels”), the shunt 10e’ (Fig. 6’) comprising:
a central flow tube 40’+42’ (Fig. 6’ – first and second tubular member 40’, 42’) having a cylindrical shape (Fig. 6’) and being sized to fit at least partially within an opening O (see annotated Fig. 1 above) in a tissue wall TS (see annotated Fig. 1 above – connector apparatus 10 fits within the annotated opening O of tissue wall TS) to form a blood flow path through the tissue wall (see annotated Fig. 1 above, and Col. 8, line 20-26 – “FIG. 1 provides a general showing of the manner in which the connector apparatus 10 of the present invention is implanted or installed within openings formed in adjacent blood vessels BV1, BV2 to maintain side-by-side connection and direct alignment of the side wall openings formed in the blood vessel BV1, BV2 ”);
a first set of one or more anchoring arms 44’ (Fig. 6’, and Col. 14, line 46-47 – “engagement flange 44’”) coupled by respective bases thereof to the central flow tube 40’+42’ (Fig. 6’ – flange 44’ is coupled to the top base of tubular member 40’), each of the first set of one or more anchoring arms 44’ (Fig. 6’) extending from the central flow tube 40’+42’ (Fig. 6’) at a first end of the central flow tube 40’+42’ (Fig. 6’ – flange 44’ extends from the first tubular member 40’) to anchor to a first side of the tissue wall TS (see annotated Fig. 1 above, Fig. 6’, and Col. 14, line 46-50 – “the engagement flanges, 44', 46' are held in spaced-apart relation such that the distance there between will cause the flanges 44', 46' to be in abutting contact with the respective luminal surfaces of the first and second passageways or blood vessels BV.sub.1, BV.sub.2”; Examiner contends that flange 44’ will engage and anchor the top side of the annotated tissue wall TS); and
a second set of one or more anchoring arms 46’ (Fig. 6’, and Col. 14, line 46-47 – “engagement flange 46’”) coupled by respective bases thereof to the central flow tube 40’+42’ (Fig. 6’ – flange 46’ is coupled to the bottom base of tubular member 42’), each of the second set of one or more anchoring arms 46’ (Fig. 6’) extending from the central flow tube 40’+42’ (Fig. 6’) at a second end of the central flow tube 40’+42’ (Fig. 6’ – flange 46’ extends from the second tubular member 42’) to anchor to a second side of the tissue wall TS (see annotated Fig. 1 below, Fig. 6’, and Col. 14, line 46-50 – “the engagement flanges, 44', 46' are held in spaced-apart relation such that the distance there between will cause the flanges 44', 46' to be in abutting contact with the respective luminal surfaces of the first and second passageways or blood vessels BV.sub.1, BV.sub.2”; Examiner contends that flange 46’ will engage and anchor the bottom side of the annotated tissue wall TS),
wherein the central flow tube 40’+42’ (Fig. 6’) is adapted to expand (Col. 20, line 13-25 discusses the longitudinal advancement of first tubular member 40’ within the second tubular member 42’ so that the engagement flanges can extend and make contact with the luminal surfaces) to increase a distance between the bases of the first set of one or more anchoring arms 44’ (Fig. 6’) and the bases of the second set of one or more anchoring arms 46’ (Fig. 6’, and Col. 14, line 46-51 – “such that the engagement flanges, 44', 46' are held in spaced-apart relation such that the distance there between will cause the flanges 44', 46' to be in abutting contact with the respective luminal surfaces of the first and second passageways or blood vessels BV.sub.1, BV.sub.2”).
However, Evard does not disclose wherein the central flow tube is adapted to axially expand in response to growth of the tissue wall, a first set and second set of anchoring arm to penetrate to a first and second side of the tissue wall.
Evard, in another embodiment, teaches that while the connector apparatus 10 can have a fixed length, e.g. connector apparatus 10e’ has a fixed length (Col. 14, line 44-46), many, if not all, of the embodiments may be alternatively constructed such that the connecting portion of the connector apparatus is adjustable, telescoping, distendable to accommodate or conform to passageways of differing length (Col. 20, line 13-25 – “Alternatively, many if not all of the embodiments of the present invention may be constructed such that the connecting portion of the connector apparatus 10 is elastic, adjustable, telescoping, distendable, of according configuration, or otherwise adjustable to accommodate or conform to passageways of differing length”).
McGuckin, in the same field of endeavor of intravascular device (Col. 2, line 23), teaches a first set 112, 110 (Fig. 9A – top engaging member 110 and 112) and second set of anchoring arm 112, 110 (Fig. 9A – bottom engaging member 110 and 112) to penetrate to a first and second side of the tissue wall (Fig. 9A – engagement members 110 and 112 penetrate a top side and a bottom side of vessel V).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shunt of Evard to be adjustable, telescoping, and distendable, also as taught by Evard, in order to allow the device to accommodate or conform to the opening of differing length (Col. 20, line 24-26 of Evard). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have come to the conclusion that in response to growth of the tissue wall (see annotated Fig. 1 of Evard), the central flow portion 40’, 42’ would ultimately expand and lengthen since the modified device has the capability of conforming to the length of the passageway. Thus, the limitation “the central flow tube is adapted to axially expand in response to growth of the tissue wall” is met.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the engagement mechanism of Evard that allows the device to anchor to the tissue wall, for the hook mechanism of McGuckin since these anchoring mechanisms perform the same function of providing attachment of the implant device to the vascular chambers. Simply substituting one anchoring means for another would yield the predicable result of allowing an implant device to anchor to the tissue wall. See MPEP 2143.
Regarding claim 11 and claim 24, Evard in view of McGuckin suggests the invention of claim 1 and claim 23, respectively. The combination further discloses wherein:
the central flow portion 40’+42’ (Fig. 6’ of Evard) comprises two or more telescoping members 40’+42’ (Fig. 6’ of Evard, and Col. 14, line 36-39 of Evard – “the respective lumens of the two tubular members 40', 42' will be in direct alignment so as to form a single continuous lumen 41 through the center of the apparatus 10e'”);
a first telescoping member 42’ (Fig. 6’ of Evard) of the two or more telescoping members 40’+42’ (Fig. 6’ of Evard) has a first diameter (Fig. 6’ of Evard, Col. 14, line 41-42 of Evard – “the interior of the second tubular member 42'”);
a second telescoping member 40’ (Fig. 6’ of Evard) of the two or more telescoping members 40’+42’ (Fig. 6’ of Evard) has a second diameter that is lesser than the first diameter (Fig. 6’ of Evard, and Col. 14, line 39-42 of Evard – “The outer surface of the first tubular member 40 is tapered inwardly toward the non-flanged end such that, as it is advanced into the interior of the second tubular member 42'”); and
the second telescoping member 40’ (Fig. 6’ of Evard) is sized to fit at least partially within a central opening of the first telescoping member 42’ (Fig. 6’ of Evard, and Col. 14, line 39-42 of Evard – “The outer surface of the first tubular member 40 is tapered inwardly toward the non-flanged end such that, as it is advanced into the interior of the second tubular member 42'”).
Regarding claim 12, Evard in view of McGuckin suggests the invention of claim 11. The combination further discloses wherein the second telescoping member 40’ (Fig. 6’ of Evard) is sized to move with respect to the first telescoping member 42’ (Fig. 6’ of Evard) to adjust an amount of overlap between the first telescoping member 42’ (Fig. 6’ of Evard) and the second telescoping member 40’ (Fig. 6’ of Evard; Examiner notes that once the modification is made as discussed in claim 1, the two telescoping members 40’ and 42’ are able to telescope and adjust to accommodate the length of passageways as taught by Evard), a flow outlet channel 41 (Fig. 6’ of Evard – singular lumen 41) of the central flow portion 40’+42’ (Fig. 6’ of Evard) being unaffected by relative positioning of the first telescoping member 42’ (Fig. 6’ of Evard) and the second telescoping member 40’ (Fig. 6’ of Evard, and Col. 14, line 36-39 – “the respective lumens of the two tubular members 40', 42' will be in direct alignment so as to form a single continuous lumen 41 through the center of the apparatus 10e'”), and wherein only a single flow path 41 (Fig. 6’ of Evard) through the opening O (see annotated Fig. 1 of Evard above) in the tissue wall TS (see annotated Fig. 1 of Evard above) is maintained when the central flow portion 40’+42’ (Fig. 6’ of Evard) is positioned within the opening O (see annotated Fig. 1 of Evard above – only one lumen 41 is formed within the opening O of tissue wall TS), such that blood flow passing through the opening O (see annotated Fig. 1 of Evard above) must pass through an inner lumen 41 (Fig. 6’ of Evard) defined by the central flow portion 40’+42’ (Fig. 6’ of Evard).
Regarding claim 13 and claim 26 and claim 33, Evard in view of McGuckin suggests the invention of claim 12 and claim 25 and claim 32, respectively. The combination further discloses wherein the second telescoping member 40’ (Fig. 6’ of Evard) is positioned to decrease the amount of overlap between the first telescoping member 42’ (Fig. 6’ of Evard) and the second telescoping member 40’ (Fig. 6’ of Evard) in response to expansion of the tissue wall TS (see annotated Fig. 1 of Evard above; Examiner notes that once the modification is made as discussed in claim 1, the two telescoping members 40’ and 42’ are able to telescope and adjust to accommodate the length of passageways as taught by Evard, including the expansion of tissue wall).
Regarding claim 14 and claim 27 and claim 34, Evard in view of McGuckin suggests the invention of claim 13 and claim 26 and claim 33, respectively. The combination further discloses wherein the first telescoping member 42’ (Fig. 6’ of Evard) and the second telescoping member 40’ (Fig. 6’ of Evard) comprise one or more connection mechanisms (Col. 14, line 42-44 – “the outer surface of the first tubular member 40' will tighten against and frictionally engage the inner surface of the second tubular member 42'”, thus friction is the connection mechanism) positioned to allow one-way movement of the second telescoping member 40’ (Fig. 6’ of Evard).
Regarding claim 21, Evard in view of McGuckin suggests the invention of claim 1. The combination further discloses wherein the first end 40’ (Fig. 6’ of Evard – the top side of member 40’) of the central flow portion 40’+’42’ (Fig. 6’ of Evard) is positionable in-line with the first side of the tissue wall TS (see annotated Fig. 1 of Evard above, and Col. 14, line 38-50 of Evard – “the flanges 44', 46' to be in abutting contact with the respective luminal surfaces of the first and second passageways or blood vessels BV.sub.1, BV.sub.2.”, thus top side of member 40’ will be abutting the luminal surface of blood vessel BV.sub.1) with the second end 42’ (Fig. 6’ of Evard – the bottom side of member 42’) of the central flow portion 40’+’42’ (Fig. 6’ of Evard) positioned in-line with the second side of the tissue wall TS (see annotated Fig. 1 of Evard above, and Col. 14, line 38-50 of Evard – “the flanges 44', 46' to be in abutting contact with the respective luminal surfaces of the first and second passageways or blood vessels BV.sub.1, BV.sub.2.”, thus bottom side of member 42’ will be abutting the luminal surface of blood vessel BV.sub.2), and wherein the central flow portion 40’+42’ (Fig. 6’ of Evard) is adapted to expand to keep the first end 40’ (Fig. 6’ of Evard – the top side of member 40’) of the central flow portion 40’+’42’ (Fig. 6’ of Evard) and the second end 42’ (Fig. 6’ of Evard – the bottom side of member 42’) of the central flow portion 40’+’42’ (Fig. 6’ of Evard) in-line with the first side of the tissue wall and the second side of the tissue wall (see annotated Fig. 1 of Evard above, and Col. 14, line 38-50 of Evard), respectively, to accommodate the growth of the tissue wall (Examiner notes that once the modification is made as discussed in claim 1, the two telescoping members 40’ and 42’ are able to telescope and adjust to accommodate the length of passageways as taught by Evard, including the expansion of tissue wall).
Regarding claim 22, Evard in view of McGuckin suggests the invention of claim 1. The combination further discloses wherein the central flow portion 40’+’42’ (Fig. 6’ of Evard) is adapted to expand uni-directionally with the tissue wall TS (see annotated Fig. 1 of Evard above, and Col. 20, line 13-25 of Evard) and in response to growth of the tissue wall without affecting flow of blood passing through and out of a flow channel 41 (Fig. 6’ of Evard, Examiner notes that once the modification is made as discussed in claim 1, the two telescoping members 40’ and 42’ are able to telescope and adjust to accommodate the length of passageways as taught by Evard, including the expansion of tissue wall while blood flows through the singular lumen 41).
Regarding claim 25 and claim 32, Evard in view of McGuckin suggests the invention of claim 23 and claim 31, respectively. The combination further discloses wherein the second telescoping member 40’ (Fig. 6’ of Evard) is sized to move with respect to the first telescoping member 42’ (Fig. 6’ of Evard) to adjust an amount of overlap between the first telescoping member 42’ (Fig. 6’ of Evard) and the second telescoping member 40’ (Fig. 6’ of Evard; Examiner notes that once the modification is made as discussed in claim 1, the two telescoping members 40’ and 42’ are able to telescope and adjust to accommodate the length of passageways as taught by Evard).
Regarding claim 28, Evard in view of McGuckin suggests the invention of claim 23. The combination further discloses wherein the central flow portion 40’+42’ (Fig. 6’ of Evard) has a length that is approximately equal to or exceeds a width of the tissue wall TS (see annotated Fig. 1 of Evard above – the length of apparatus 10 is equal or exceeds the width of tissue wall TS).
Regarding claim 29, Evard in view of McGuckin suggests the invention of claim 23. The combination further discloses wherein the central flow portion 40’+42’ (Fig. 6’ of Evard) has a cylindrical shape (Fig. 6’ of Evard).
Regarding claim 31, Evard in view of McGuckin suggests the invention of claim 30. The combination further discloses wherein:
the central flow tube 40’+42’ (Fig. 6’ of Evard) comprises two or more telescoping members 40’+42’ (Fig. 6’ of Evard, and Col. 14, line 36-39 of Evard – “the respective lumens of the two tubular members 40', 42' will be in direct alignment so as to form a single continuous lumen 41 through the center of the apparatus 10e'”);
a first telescoping member 42’ (Fig. 6’ of Evard) of the two or more telescoping members 40’+42’ (Fig. 6’ of Evard) has a first diameter (Fig. 6’ of Evard) sized to abut an edge of the opening O (see annotated Fig. 1 of Evard above) in the tissue wall TS (see annotated Fig. 1 of Evard above – the body of member 42’ will be in contact with the interior of opening O);
a second telescoping member 40’ (Fig. 6’ of Evard) of the two or more telescoping members 40’+42’ (Fig. 6’ of Evard) has a second diameter that is lesser than the first diameter (Fig. 6’ of Evard, and Col. 14, line 39-42 of Evard – “The outer surface of the first tubular member 40 is tapered inwardly toward the non-flanged end such that, as it is advanced into the interior of the second tubular member 42'”); and
the second telescoping member 40’ (Fig. 6’ of Evard) is sized to fit at least partially within a central opening of the first telescoping member 42’ (Fig. 6’ of Evard, and Col. 14, line 39-42 of Evard – “The outer surface of the first tubular member 40 is tapered inwardly toward the non-flanged end such that, as it is advanced into the interior of the second tubular member 42'”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Duffy et al. US 8,968,233 B2 teaches an arteriovenous shunt with movable component.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUYNH DAO LE/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
Prosecution Insights