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 05/13/26 was filed. The submission 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 amendment filed 03/10/26 has been entered. Claims 1, 7-9, and 21-31 have been amended. Claims 10-14 are in the original/ previously presented form. Claims 2-6, 15-20 are cancelled. Thus, claims 1, 7-14, and 21-31 remain pending in the application. There were no objections or 112 rejections previously set forth in the Non-Final Office Action mailed 12/12/25. Therefore, there are no objections or 112 rejections withstanding.
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.
Claims 1, 7-8, 10-14, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Kleiner (U.S. PGPUB No. 2015/0148785) in view of Abrams et al. (U.S. PGPUB No. 2005/0143773), hereinafter Abrams.
Regarding claim 1, Kleiner discloses a medical device, comprising:
a shaft (30, see FIG. 21B) defining a lumen (see [0091]: tube 30 has lumen for draining fluids from sponge when suction is applied) and a distal portion (see portion of 30 within expandable device/sponge 14 seen best in FIG. 21C), the distal portion (see portion of 30 within expandable device 14 seen best in FIG. 21C) defining a side opening (see holes of 30 in FIGs. 21A-C as described in [0087]: suction tube 30 extends into sponge and has through openings) in fluid communication with the lumen (see [0121]: 30 has applied suction for draining fluids via lumen as described in [0091]); and
a device (assembly 140 seen in FIG.21A) coupled to the distal portion (see portion of 30 within expandable device/sponge 14 seen best in FIG. 21C) of the shaft (30) and overlying (as seen in FIG. 21B and described in [0087]: tube 30 extends into sponge) the side opening (holes on 30), the device (140) including:
an expandable member (14, see [0084]: biocompatible sponge 14 and [0121]: vac sponge 14) configured to expand laterally outward (see [0121-0122]) from a collapsed state (as seen in FIG. 21A) to an expanded state (as seen in FIG. 21C), and configured to permit fluid to flow through the expandable member (14) and into the side opening (holes on tube 30, see FIG. 21B and [0091]: suction tube 30 drains fluids from external environment/ wound through the sponge 14); and
a constricting device (142) positioned in contact with (see [0121]: 142 is a “covering” that completely surrounds outer face 32 of sponge 14 and therefore is positioned in contact with the sponge 14) the expandable member (14) and configured to move relative to (see [0121-0122]: wrap 142 is pulled to unsheath the sponge) the expandable member (14) from a first position (fully covering length of 14 as in FIG.21A, the wrap has not been pulled yet) to a second position (fully retracted/ withdrawn wrap as in FIG. 21C);
wherein the expandable member (14) is in the collapsed state (see FIG. 21A) when the constricting device (142) is in the first position (fully covering length of 14 as in FIG.21A, the wrap has not been pulled yet) and the expandable member (14) is in the expanded state (see FIG. 21C) when the constricting device (142) is in the second position (fully retracted/ withdrawn wrap as in FIG. 21C),
wherein the expandable member (14) surrounds (see [0087]: tube 30 extends into sponge== sponge surrounds the shaft 30) the shaft (30) along a length (see ‘Modified FIG. 21C’ below)
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of the expandable member (14) in the expanded state (see FIG. 21C).
Kleiner (in the embodiment of FIG. 21A-C) is silent to the expandable member “is fixed to” the shaft along “an entire” length of the expandable member in the expanded state and “wherein the shaft comprises a slot proximal to the expandable member and extending into the lumen, wherein the constricting device comprises a single thread extending outwardly from the lumen via the slot, and wherein application of a proximal force on the single thread expands a proximal end of the expandable member before expanding a distal end of the expandable member.”
However, in an alternate embodiment (see FIG. 1), Kleiner teaches a medical device comprising a shaft (22) and an expandable member (14), wherein the expandable member (14) is fixed to the shaft (22) along an entire length (as seen in FIG. 1. See also [0085]: The sponge is fixed to the drainage tube along the sponge length) of the expandable member (14) in an expanded state (as shown in FIG. 1).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drainage tube shaft with side openings disclosed in Kleiner (FIG. 21A-C) to extend through and be fixed along the entire sponge length as taught by Kleiner (FIG. 1) for the purpose of retaining the sponge in position while the sponge is placed (see [0085]), which would be advantageous to the FIG. 21A-C embodiment that experiences axial forces to withdraw the wrap 142 when deploying the sponge (thus, the fixation and extension of tube 30 through sponge 14 ensures that the alignment of the sponge over the side openings of 30 is maintained to ensure proper functioning of fluid drainage from wound, into sponge 14, and out drainage tube 30), thus achieving the expandable member “is fixed to” the shaft along “an entire” length of the expandable member in the expanded state.
Kleiner (Fig. 21A-C in view of FIG. 1) remains silent to “wherein the shaft comprises a slot proximal to the expandable member and extending into the lumen, wherein the constricting device comprises a single thread extending outwardly from the lumen via the slot, and wherein application of a proximal force on the single thread expands a proximal end of the expandable member before expanding a distal end of the expandable member.”
However, Abrams teaches a medical device comprising a shaft (11, see FIG. 2) having a distal portion (region between numerals 30 and 22) and defining a lumen (14, see [0040]). Abrams further teaches a constricting device (32) formed of a thread (24, see [0041-0044]) and disposed over an expandable member (34), wherein the shaft (11) comprises a slot (26) proximal to (rightward in FIG. 2) the expandable member (34) and extending into the lumen (see [0042]), wherein the constricting device (32) comprises a single thread (as shown in FIG. 2 and described in [0040-0044]) extending outwardly from the lumen via the slot (26, see [0042]), and wherein application of a proximal force on the single thread expands the expandable member (see [0044]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the constricting device disposed over the outer surface of a distal portion of the shaft and the expandable member and withdrawn proximally as disclosed in Kleiner with the constricting device formed of a single thread extending outwardly from a shaft lumen via a slot and withdrawn proximally into the shaft slot and lumen as taught by Abrams.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a constricting device formed as a wrap 142 that is withdrawn proximally relative to a shaft disclosed in Kleiner [0121-0122]) for another known element (a constricting device formed of a wire 24 that is withdrawn proximally into a slot of a shaft as taught in Abrams) in the art to obtain the predictable result of maintaining an expandable member in a compressed state by a constricting device, wherein proximal retraction of the constricting device allows expansion of the expandable member (see MPEP § 2143.I.B), thus achieving “wherein the shaft comprises a slot proximal to the expandable member and extending into the lumen, wherein the constricting device comprises a single thread extending outwardly from the lumen via the slot, and wherein application of a proximal force on the single thread expands …the expandable member...”
Kleiner (FIG. 21A-C in view of FIG. 1) in view of Abrams (FIG. 2) remain silent to wherein application of a proximal force on the single thread expands “a proximal end of” the expandable member “before expanding a distal end of the expandable member.”
However, Abrams further teaches that the number and placement of the ports and threads will enable a wide range of configurations for the device (see [0050]), such as permitting a proximal end of the expandable member to expand before expanding a distal end of the expandable member (see [0045], [0048]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the placement of the single thread of the constricting device taught by Kleiner (FIG. 21A-C in view of FIG. 1) in view of Abrams (FIG. 2) such that the proximal end of the expandable member expands before the distal end as taught by Abrams (such as by modifying the winding placement of the single thread, see ‘Modified Abrams’ below)
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for the purpose of designing the device for an application where it is desirable for the proximal end of the expandable member to expand before the other end (see [0048]), thus achieving wherein application of a proximal force on the single thread expands “a proximal end of” the expandable member “before expanding a distal end of the expandable member.”
Regarding claim 7, the modified system of Kleiner teaches the medical device of claim 1, but Kleiner is silent to “wherein the single thread is attached to the distal portion of the shaft.”
However, Abrams teaches a medical device (see FIG. 2) comprising a shaft (11) having a distal portion (region between numerals 30 and 22) and a constricting device (32) formed of a single thread (24, see FIG. 2 and description in [0040-0044]), wherein the single thread is attached to (thread 24 attached to shaft at least by way of slot and winding around expandable member, aligning with Applicant disclosure as shown in at least FIGs. 7A-B of the current Application) the distal portion (region between numerals 30 and 22) of the shaft (11).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the constricting device disposed over the outer surface of a distal portion of the shaft and the expandable member and withdrawn proximally as disclosed in Kleiner with the constricting device formed of a single thread attached to the distal portion of the shaft and withdrawn proximally as taught by Abrams.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a constricting device formed as a wrap 142 that is withdrawn proximally relative to a shaft disclosed in Kleiner [0121-0122]) for another known element (a constricting device formed of a wire 24 that is withdrawn proximally into a slot of a shaft as taught in Abrams) in the art to obtain the predictable result of maintaining an expandable member in a compressed state by a constricting device, wherein proximal retraction of the constricting device allows expansion of the expandable member (see MPEP § 2143.I.B), thus achieving “wherein the single thread is attached to the distal portion of the shaft.”
Regarding claim 8, the modified system of Kleiner teaches the medical device of claim 1, and Kleiner further discloses wherein a proximal portion (as described in [0122]) of the constricting device (142, see FIG. 21A-C) extends outside of the patient (see [0122]: 142 protrudes externally to facilitate withdrawal/ pulling rearwardly),and wherein a distal portion (as seen in FIG. 21A) of the constricting device (142) is disposed over an outer surface (see outer surface of 30 as shown in FIG. 21C) of the distal portion (portion within sponge 14) of the shaft (30) and extends about the expandable member (14, see [0121]: 142 covers surface 32 of sponge 14 and thus is also disposed “over” an outer surface of the tube 30).
Kleiner is silent to wherein a proximal portion of “the single thread extends through the lumen” and wherein a distal portion of “the single thread” is disposed over an outer surface of the distal portion of the shaft and extends about the expandable member.
However, Abrams teaches a medical device comprising a shaft (11, see FIG. 2) having a distal portion (region between numerals 30 and 22) and defining a lumen (14, see [0040]). Abrams further teaches a constricting device (32) formed of a single thread (24, see [0041-0044]), wherein a proximal portion (16, best seen in FIG. 1 before the retraction of the thread which begins in FIG. 2) of the single thread (24) extends through (see [0042-0043]) the lumen (14) and wherein a distal portion (32) of the single thread (24) is disposed over (see FIG. 1 and [0043]) an outer surface (see outline of 34 in FIG. 1) of the distal portion (region between numerals 30 and 22) of the shaft (11) and extends about (see [0043]: wire 32 coiled about 34) an expandable member (34).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the constricting device disposed over the outer surface of a distal portion of the shaft and the expandable member and withdrawn proximally as disclosed in Kleiner with the constricting device disposed over the outer surface of a distal portion of the shaft and the expandable member and withdrawn proximally into the shaft slot and lumen a proximal portion of a thread as taught by Abrams.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a constricting device formed as a wrap 142 that is withdrawn proximally relative to a shaft disclosed in Kleiner [0121-0122]) for another known element (a constricting device formed of a wire 24 that is withdrawn proximally into a slot of a shaft as taught in Abrams) in the art to obtain the predictable result of maintaining an expandable member in a compressed state by a constricting device, wherein proximal retraction of the constricting device allows expansion of the expandable member (see MPEP § 2143.I.B), thus achieving wherein a proximal portion of “the single thread extends through the lumen” and wherein a distal portion of “the single thread” is disposed over an outer surface of the distal portion of the shaft and extends about the expandable member.
Regarding claim 10, the modified system of Kleiner teaches the medical device of claim 1, and Kleiner discloses the constricting device (142, see FIG. 21A) is configured to be fixed relative to (see [0121-0122]: 142 is fixed in place until user manually grips and pulls covering 142 proximally for removal from the expandable member) the expandable member (14) to thereby maintain the constricting device (142) in at least one of the first position (as in FIG. 21A) or the second position (as in FIG. 21C) and the expandable member (14) in at least one of the expanded state (as shown in FIG. 21C) or the collapsed state (as shown in FIG. 21A).
Kleiner is silent to “further including a locking mechanism configured to fix the constricting device” relative to the expandable member to thereby maintain the constricting device in at least one of the first position or the second position and the expandable member in at least one of the expanded state or the collapsed state.
However, Abrams teaches a medical device comprising a shaft (11, see FIG. 2) and a constricting device (32) formed of a thread (24, see [0041-0044]) surrounding an expandable member (34). Abrams teaches the device further including a locking mechanism (20, see FIG. 1) configured to fix (see [0040]: wire 16 with the constricting device 32 at its distal end is actuated by actuatable mechanism 20. Therefore, the mechanism 20 is configured to ‘fix’/ lock the constricting device in the position as shown in FIG. 1 until 20 is actuated to cause retraction of the wire, which results in the expandable member moving from the collapsed configuration in FIG. 1 to the expanded configuration in FIG. 3) the constricting device (32) relative to the expandable member (34) to thereby maintain the constricting device (32) in at least one of a first position (see FIG. 1) or a second position (see FIG. 3) and the expandable member (34) in at least one of an expanded state (as shown in FIG. 3) or a collapsed state (as shown in FIG. 1).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the constricting device disclosed in Kleiner to include a locking mechanism configured to fix the constricting device as taught by Abrams for the purpose of forming a mechanically actuated mechanism for retraction of the constricting device (see [0040]), which would be advantageous to Kleiner that only has manual retraction of the constricting device as described in [0121-0122], thus achieving “further including a locking mechanism configured to fix the constricting device” relative to the expandable member to thereby maintain the constricting device in at least one of the first position or the second position and the expandable member in at least one of the expanded state or the collapsed state.
Regarding claim 11, Kleiner discloses the medical device of claim 1, and Kleiner discloses further including a pressure source (see [0121]: negative pressure applied to sponge via tube 30 in FIG. 21A-C, which would require a pressure source as described in [0090] for creating the negative pressure) in fluid communication with the lumen (see [0086-0091]), wherein the pressure source (see at least [0090] and [0121]) is configured to generate suction at the distal portion of the shaft via the side opening such that fluid positioned adjacent to the distal portion are drawn into the lumen through the expandable member (see [0086-0091]: providing suction to tube 30 drains fluids from external environment/ wound through the sponge 14).
Regarding claim 12, Kleiner discloses the medical device of claim 1, and Kleiner further discloses wherein the expandable member (14, see FIG. 21C) includes a porous body including a plurality of fibers (see [0139]: sponges of the device, such as sponge 14,can be formed of open cell polyurethane foam. Thus, Kleiner teaches an open-cell polyurethane material equivalent to that disclosed by Applicant in the instant Application’s [0039]).
Regarding claim 13, Kleiner discloses the medical device of claim 1, and Kleiner further discloses wherein the expandable member (14) has a greater diameter (see diameter expansion in progression through Fig 21A-C) in the expanded state (see FIG.21C) than the collapsed state (see FIG. 21A).
Regarding claim 14, Kleiner discloses the medical device of claim 1, and Kleiner further discloses wherein the side opening (see holes of 30 in FIGs. 21A-C as described in [0087]: suction tube 30 extends into sponge and has through openings) is one of a plurality of side openings (see multiple holes shown in Fig 21A-C) extending through the shaft (30).
Regarding claim 22, Kleiner discloses the medical device of claim 1, and Kleiner further discloses wherein the constricting device (142) includes a wrap (see [0121-0122]), and wherein a distal portion (see [0122]: proximal portion of wrap outside patient and thus the portion 142 shown about sponge 14 must be distal portion) of the wrap (142) extends about the expandable member (14) in the collapsed state (see FIG. 21A).
Kleiner is silent to the wrap being specifically “a single thread” and wherein a distal portion of the single thread extends about the expandable member in the collapsed state “and the expanded state”.
However, Abrams teaches a medical device comprising a constricting device (32, see FIG. 2) formed of a single thread (24, see [0041-0044]) and disposed over an expandable member (34), wherein a distal portion (32) of the single thread (24) extends about the expandable member (34) in the collapsed state (see FIG. 1 and [0043]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the constricting device disposed over the outer surface of a distal portion of the shaft and the expandable member and withdrawn proximally as disclosed in Kleiner with the constricting device formed of a single thread extending about the expandable member and withdrawn proximally as taught by Abrams.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a constricting device formed as a wrap 142 that is withdrawn proximally relative to a shaft disclosed in Kleiner [0121-0122]) for another known element (a constricting device formed of a wire 24 that is withdrawn proximally into a slot of a shaft as taught in Abrams) in the art to obtain the predictable result of maintaining an expandable member in a compressed state by a constricting device, wherein proximal retraction of the constricting device allows expansion of the expandable member (see MPEP § 2143.I.B), thus achieving the wrap being specifically “a single thread” and the single thread extends about the expandable member in the collapsed state.
Kleiner (FIG.21A-C in view of FIG.1) in view of Abrams (FIG. 2) remain silent to wherein a distal portion of the single thread extends about the expandable member in the collapsed state “and the expanded state”.
However, Abrams further teaches that the number and placement of the ports and threads will enable a wide range of configurations for the device (see [0050]), such as permitting a proximal end of the expandable member to expand before expanding a distal end of the expandable member (see [0045], [0048]) such that a distal portion of the single thread extends about the expandable member in the collapsed state and the expanded state (see ‘Modified Abrams’ in the rejection of claim 1 above. If the proximal end expands first, the distal portion of the wire still contacts the expandable member in the expanded state).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the placement of the single thread of the constricting device taught by Kleiner (FIG. 21A-C in view of FIG. 1) in view of Abrams (FIG. 2) such that the proximal end of the expandable member expands before the distal end as taught by Abrams (such as by modifying the winding placement of the single thread, see ‘Modified Abrams’ above) for the purpose of designing the device for an application where it is desirable for the proximal end of the expandable member to expand before the other end (see [0048]), thus achieving wherein a distal portion of the single thread extends about the expandable member in the collapsed state “and the expanded state”.
Regarding claim 23, Kleiner discloses a medical device, comprising:
a shaft (30, see FIG. 21B) defining a lumen (see [0091]: tube 30 has lumen for draining fluids from sponge when suction is applied) and a distal portion (see portion of 30 within expandable device/sponge 14 seen best in FIG. 21C), the distal portion (see portion of 30 within expandable device 14 seen best in FIG. 21C) including at least one side opening (see holes of 30 in FIGs. 21A-C as described in [0087]: suction tube 30 extends into sponge and has through openings) in fluid communication with the lumen (see [0121]: 30 has applied suction for draining fluids via lumen as described in [0091]);
an expandable member (14, see [0084]: biocompatible sponge 14 and [0121]: vac sponge 14) disposed over (as seen in FIGs. 21A-C and described in [0087]: tube 30 extends into sponge and therefore sponge 14 is disposed over the tube 30 with side openings) the at least one side opening (see holes of 30) and configured to permit fluid flow through the expandable member (14) and into the at least one side opening (see [0091]: suction tube 30 drains fluids from external environment/ wound through the sponge 14); and
a constricting device (142) positioned in contact with (see [0121]: 142 is a “covering” that completely surrounds outer face 32 of sponge 14 and therefore is positioned in contact with the sponge 14) the expandable member (14) and configured to apply a constraining force against (see [0121-0122]: resting/ normal position of sponge 14 is that shown in FIG. 21C. Therefore, the constricting device wrapping 142 MUST apply a constraining force against sponge to force sponge into abnormal/ non-preferred position as shown in FIG. 21A) the expandable member (14),
wherein the constricting device (142) is movable relative to (see [0121-0122]: wrap 142 is pulled== movable to unsheath the sponge) the expandable member (14) to expand (as shown in progression from FIG. 21A to FIG. 21C) the expandable member (14) radially outward from a collapsed state (as seen in FIG. 21A) to an expanded state (as seen in FIG. 21C),
wherein the expandable member (14) surrounds the shaft (30) along a length (see the length labeled in ‘Modified FIG. 21C’ provided in the claim 1 rejection above) of the expandable member (14) in the collapsed state (member 14 surrounds shaft 30 along same length in FIG. 21A as the length shown in ‘Modified FIG. 21C’ above) and in the expanded state (as shown in ‘Modified FIG.21C’ above).
Kleiner (in the embodiment of FIG. 21A-C) is silent to the expandable member “is fixed to” the shaft along “an entire” length of the expandable member in the collapsed state and in the expanded state and “wherein the shaft comprises a slot proximal to the expandable member and extending into the lumen, wherein the constricting device comprises a single thread extending outwardly from the lumen via the slot, and wherein application of a proximal force on the single thread expands a proximal end of the expandable member before expanding a distal end of the expandable member.”
However, in an alternate embodiment (see FIG. 1), Kleiner teaches a medical device comprising a shaft (22) and an expandable member (14), wherein the expandable member (14) is fixed to the shaft (22) along an entire length (as seen in FIG. 1. See also [0085]: The sponge is fixed to the drainage tube along the sponge length) of the expandable member (14) in an expanded state (as shown in FIG. 1).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drainage tube shaft with side openings disclosed in Kleiner (FIG. 21A-C) to extend through and be fixed along the entire sponge length as taught by Kleiner (FIG. 1) for the purpose of retaining the sponge in position while the sponge is placed (see [0085]), which would be advantageous to the FIG. 21A-C embodiment that experiences axial forces to withdraw the wrap 142 when deploying the sponge (thus, the fixation and extension of tube 30 through sponge 14 ensures that the alignment of the sponge over the side openings of 30 is maintained to ensure proper functioning of fluid drainage from wound, into sponge 14, and out drainage tube 30), thus achieving the expandable member “is fixed to” the shaft along “an entire” length of the expandable member in the expanded state.
Kleiner (Fig. 21A-C in view of FIG. 1) remains silent to “wherein the shaft comprises a slot proximal to the expandable member and extending into the lumen, wherein the constricting device comprises a single thread extending outwardly from the lumen via the slot, and wherein application of a proximal force on the single thread expands a proximal end of the expandable member before expanding a distal end of the expandable member.”
However, Abrams teaches a medical device comprising a shaft (11, see FIG. 2) having a distal portion (region between numerals 30 and 22) and defining a lumen (14, see [0040]). Abrams further teaches a constricting device (32) formed of a thread (24, see [0041-0044]) and disposed over an expandable member (34), wherein the shaft (11) comprises a slot (26) proximal to (rightward in FIG. 2) the expandable member (34) and extending into the lumen (see [0042]), wherein the constricting device (32) comprises a single thread (as shown in FIG. 2 and described in [0040-0044]) extending outwardly from the lumen via the slot (26, see [0042]), and wherein application of a proximal force on the single thread expands the expandable member (see [0044]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the constricting device disposed over the outer surface of a distal portion of the shaft and the expandable member and withdrawn proximally as disclosed in Kleiner with the constricting device formed of a single thread extending outwardly from a shaft lumen via a slot and withdrawn proximally into the shaft slot and lumen as taught by Abrams.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a constricting device formed as a wrap 142 that is withdrawn proximally relative to a shaft disclosed in Kleiner [0121-0122]) for another known element (a constricting device formed of a wire 24 that is withdrawn proximally into a slot of a shaft as taught in Abrams) in the art to obtain the predictable result of maintaining an expandable member in a compressed state by a constricting device, wherein proximal retraction of the constricting device allows expansion of the expandable member (see MPEP § 2143.I.B), thus achieving “wherein the shaft comprises a slot proximal to the expandable member and extending into the lumen, wherein the constricting device comprises a single thread extending outwardly from the lumen via the slot, and wherein application of a proximal force on the single thread expands …the expandable member...”
Kleiner (FIG. 21A-C in view of FIG. 1) in view of Abrams (FIG. 2) remain silent to wherein application of a proximal force on the single thread expands “a proximal end of” the expandable member “before expanding a distal end of the expandable member.”
However, Abrams further teaches that the number and placement of the ports and threads will enable a wide range of configurations for the device (see [0050]), such as permitting a proximal end of the expandable member to expand before expanding a distal end of the expandable member (see [0045], [0048]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the placement of the single thread of the constricting device taught by Kleiner (FIG. 21A-C in view of FIG. 1) in view of Abrams (FIG. 2) such that the proximal end of the expandable member expands before the distal end as taught by Abrams (such as by modifying the winding placement of the single thread, see ‘Modified Abrams’ below)
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for the purpose of designing the device for an application where it is desirable for the proximal end of the expandable member to expand before the other end (see [0048]), thus achieving wherein application of a proximal force on the single thread expands “a proximal end of” the expandable member “before expanding a distal end of the expandable member.”
Regarding claim 24, Kleiner discloses the medical device of claim 23, and Kleiner further discloses wherein the constricting device (142) includes a wrap (see [0121-0122]), and wherein a distal portion (see [0122]: proximal portion of wrap outside patient and thus the portion 142 shown about sponge 14 must be distal portion) of the wrap (142) extends about the expandable member (14, see FIG. 21A).
Kleiner is silent to the constricting device being specifically “a single thread”.
However, Abrams teaches a medical device comprising a constricting device, wherein the constricting device includes a single thread (24, see FIG. 2 and [0041-0044]), and wherein a distal portion (32) of the thread (24) extends about (see [0043]: wire 32 coiled about 34) the expandable member (34).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the constricting device with a distal portion disposed over the expandable member as disclosed in Kleiner with the constricting device disposed over the expandable member as taught by Abrams.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a constricting device formed as a wrap 142 that extends over an expandable member and is withdrawn proximally relative to a shaft disclosed in Kleiner [0121-0122]) for another known element (a constricting device formed of a single thread that extends over an expandable member and is withdrawn proximally into a slot of a shaft as taught in Abrams) in the art to obtain the predictable result of maintaining an expandable member in a compressed state by a constricting device, wherein proximal retraction of the constricting device allows expansion of the expandable member (see MPEP § 2143.I.B), thus achieving the constricting device being specifically “a single thread”.
Regarding claim 25, the modified system of Kleiner teaches the medical device of claim 24, and Kleiner further discloses wherein the constricting device (142) includes a wrap (see [0121-0122]), and wherein a distal portion (see [0122]: proximal portion of wrap outside patient and thus the portion 142 shown about sponge 14 must be distal portion) of the wrap (142) extends about the expandable member (14) in the collapsed state (see FIG. 21A).
Kleiner is silent to the wrap being specifically “a single thread” and wherein a distal portion of the single thread extends about the expandable member in the collapsed state “and the expanded state”.
However, Abrams teaches a medical device comprising a constricting device (32, see FIG. 2) formed of a single thread (24, see [0041-0044]) and disposed over an expandable member (34), wherein a distal portion (32) of the single thread (24) extends about the expandable member (34) in the collapsed state (see FIG. 1 and [0043]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the constricting device disposed over the outer surface of a distal portion of the shaft and the expandable member and withdrawn proximally as disclosed in Kleiner with the constricting device formed of a single thread extending about the expandable member and withdrawn proximally as taught by Abrams.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a constricting device formed as a wrap 142 that is withdrawn proximally relative to a shaft disclosed in Kleiner [0121-0122]) for another known element (a constricting device formed of a wire 24 that is withdrawn proximally into a slot of a shaft as taught in Abrams) in the art to obtain the predictable result of maintaining an expandable member in a compressed state by a constricting device, wherein proximal retraction of the constricting device allows expansion of the expandable member (see MPEP § 2143.I.B), thus achieving the wrap being specifically “a single thread” and the single thread extends about the expandable member in the collapsed state.
Kleiner (FIG.21A-C in view of FIG.1) in view of Abrams (FIG. 2) remain silent to wherein a distal portion of the single thread extends about the expandable member in the collapsed state “and the expanded state”.
However, Abrams further teaches that the number and placement of the ports and threads will enable a wide range of configurations for the device (see [0050]), such as permitting a proximal end of the expandable member to expand before expanding a distal end of the expandable member (see [0045], [0048]) such that a distal portion of the single thread extends about the expandable member in the collapsed state and the expanded state (see ‘Modified Abrams’ in the rejection of claim 1 above. If the proximal end expands first, the distal portion of the wire still contacts the expandable member in the expanded state).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the placement of the single thread of the constricting device taught by Kleiner (FIG. 21A-C in view of FIG. 1) in view of Abrams (FIG. 2) such that the proximal end of the expandable member expands before the distal end as taught by Abrams (such as by modifying the winding placement of the single thread, see ‘Modified Abrams’ above) for the purpose of designing the device for an application where it is desirable for the proximal end of the expandable member to expand before the other end (see [0048]), thus achieving wherein a distal portion of the single thread extends about the expandable member in the collapsed state “and the expanded state”.
Regarding claim 29, Kleiner discloses a medical device, comprising:
a shaft (30, see FIG. 21B) defining a lumen (see [0091]: tube 30 has lumen for draining fluids from sponge when suction is applied) and a distal portion (see portion of 30 within expandable device/sponge 14 seen best in FIG. 21C), the distal portion (see portion of 30 within expandable device 14 seen best in FIG. 21C) including at least one side opening (see holes of 30 in FIGs. 21A-C as described in [0087]: suction tube 30 extends into sponge and has through openings) in fluid communication with the lumen (see [0121]: 30 has applied suction for draining fluids via lumen as described in [0091]);
an expandable member (14) disposed along an exterior surface (exterior surface shown by outline of tube 30 within sponge 14 as in FIGs. 21A-C and described in [0087]: tube 30 extends into sponge and thus 14 along an exterior surface of the shaft 30) of the shaft (30) and over (see [0087]: tube with openings extend into sponge) the at least one side opening (holes in tube 30), wherein the expandable member 914) is configured to permit fluid flow through the expandable member (14) and into the at least one side opening (holes on tube 30, see FIG. 21B and [0091]: suction tube 30 drains fluids from external environment/ wound through the sponge 14); and
a wrap (142) positioned in contact with (see [0121]: 142 is a “covering” that completely surrounds outer face 32 of sponge 14 and therefore is positioned in contact with the sponge 14) the expandable member (14),
wherein the wrap (142) is movable relative to the expandable member (14) to transition (see [0121-0122]: wrap 142 is pulled==moved relative to sponge 14 to unsheath== transition the sponge) the expandable member (14) from a collapsed state (as shown in FIG. 21A) to an expanded state (as shown in FIG. 21C), and
wherein the expandable member (14) surrounds the exterior surface of the shaft (30) along a length (see the length labeled in ‘Modified FIG. 21C’ provided in the claim 1 rejection above) of the expandable member (14) in the collapsed state (member 14 surrounds shaft 30 along same length in FIG. 21A as the length shown in ‘Modified FIG. 21C’ above) and in the expanded state (as shown in ‘Modified FIG.21C’ above).
Kleiner (in the embodiment of FIG. 21A-C) is silent to the expandable member “is fixed to” the exterior surface of the shaft along “an entire” length of the expandable member in the collapsed state and in the expanded state, the constricting device in contact with the expandable member being “a single thread”, “wherein the shaft comprises a slot proximal to the expandable member, and the single thread extends outwardly from the lumen via the slot”, wherein the “single thread” is movable relative to the expandable member, and “wherein application of a proximal force on the single thread expands a proximal end of the expandable member before expanding a distal end of the expandable member”.
However, in an alternate embodiment (see FIG. 1), Kleiner teaches a medical device comprising a shaft (22) and an expandable member (14), wherein the expandable member (14) is fixed to the exterior of the shaft (22) along an entire length (as seen in FIG. 1. See also [0085]: The sponge is fixed to the drainage tube along the sponge length) of the expandable member (14) in a collapsed state and an expanded state (as shown in FIG. 1. See also [0085]: The sponge is fixed to the drainage tube along the sponge length by, for example, heat welding and is therefore fixed in all states such as the collapsed state, i.e.: FIG.21A and the expanded state, i.e.: FIG. 21C).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drainage tube shaft with side openings disclosed in Kleiner (FIG. 21A-C) to extend through and be fixed along the entire sponge length as taught by Kleiner (FIG. 1) for the purpose of retaining the sponge in position while the sponge is placed (see [0085]), which would be advantageous to the FIG. 21A-C embodiment that experiences axial forces to withdraw the wrap 142 when deploying the sponge (thus, the fixation and extension of tube 30 through sponge 14 ensures that the alignment of the sponge over the side openings of 30 is maintained to ensure proper functioning of fluid drainage from wound, into sponge 14, and out drainage tube 30), thus achieving the expandable member “is fixed to” the exterior surface of the shaft along “an entire” length of the expandable member in the collapsed state and in the expanded state.
Kleiner (FIG. 21A-C) in view of Kleiner (FIG. 1) remain silent to the constricting device in contact with the expandable member being “a single thread”, “wherein the shaft comprises a slot proximal to the expandable member, and the single thread extends outwardly from the lumen via the slot”, wherein the “single thread” is movable relative to the expandable member, and “wherein application of a proximal force on the single thread expands a proximal end of the expandable member before expanding a distal end of the expandable member”.
However, Abrams teaches a medical device comprising a shaft (11, see FIG. 2) having a distal portion (region between numerals 30 and 22) and defining a lumen (14, see [0040]). Abrams further teaches a constricting device (32) formed of a single thread (24, see [0041-0044]) and disposed over an expandable member (34), wherein the shaft (11) comprises a slot (26) proximal to (rightward in FIG. 2) the expandable member (34) and the single thread (24) extends outwardly (as shown in FIG. 2) from the lumen via the slot (26, see [0042]), wherein the single thread (24) is movable relative the expandable member (34, as shown in progression from FIG. 1 to FIG. 2 and described in [0040-0044]), and wherein application of a proximal force on the single thread expands the expandable member (see [0044]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the constricting device disposed over the outer surface of a distal portion of the shaft and the expandable member and withdrawn proximally as disclosed in Kleiner with the constricting device formed of a single thread extending outwardly from a shaft lumen via a slot and withdrawn proximally into the shaft slot and lumen as taught by Abrams.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a constricting device formed as a wrap 142 that is withdrawn proximally relative to a shaft disclosed in Kleiner [0121-0122]) for another known element (a constricting device formed of a wire 24 that is withdrawn proximally into a slot of a shaft as taught in Abrams) in the art to obtain the predictable result of maintaining an expandable member in a compressed state by a constricting device, wherein proximal retraction of the constricting device allows expansion of the expandable member (see MPEP § 2143.I.B), thus achieving the constricting device in contact with the expandable member being “a single thread”, “wherein the shaft comprises a slot proximal to the expandable member, and the single thread extends outwardly from the lumen via the slot”, wherein the “single thread” is movable relative to the expandable member, and “wherein application of a proximal force on the single thread expands … the expandable member…”.
Kleiner (FIG. 21A-C in view of FIG. 1) in view of Abrams (FIG. 2) remain silent to wherein application of a proximal force on the single thread expands “a proximal end of” the expandable member “before expanding a distal end of the expandable member.”
However, Abrams further teaches that the number and placement of the ports and threads will enable a wide range of configurations for the device (see [0050]), such as permitting a proximal end of the expandable member to expand before expanding a distal end of the expandable member (see [0045], [0048]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the placement of the single thread of the constricting device taught by Kleiner (FIG. 21A-C in view of FIG. 1) in view of Abrams (FIG. 2) such that the proximal end of the expandable member expands before the distal end as taught by Abrams (such as by modifying the winding placement of the single thread, see ‘Modified Abrams’ below)
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for the purpose of designing the device for an application where it is desirable for the proximal end of the expandable member to expand before the other end (see [0048]), thus achieving wherein application of a proximal force on the single thread expands “a proximal end of” the expandable member “before expanding a distal end of the expandable member.”
Regarding claim 31, the modified system of Kleiner teaches the device of claim 29, and Kleiner further discloses wherein the constricting device (142) includes a wrap (see [0121-0122]), and wherein a distal portion (see [0122]: proximal portion of wrap outside patient and thus the portion 142 shown about sponge 14 must be distal portion) of the wrap (142) extends about the expandable member (14) in the collapsed state (see FIG. 21A).
Kleiner is silent to the wrap being specifically “a single thread” and wherein a distal portion of the single thread extends about the expandable member “in the expanded state”.
However, Abrams teaches a medical device comprising a constricting device (32, see FIG. 2) formed of a single thread (24, see [0041-0044]) and disposed over an expandable member (34), wherein a distal portion (32) of the single thread (24) extends about the expandable member (34) in the collapsed state (see FIG. 1 and [0043]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the constricting device disposed over the outer surface of a distal portion of the shaft and the expandable member and withdrawn proximally as disclosed in Kleiner with the constricting device formed of a single thread extending about the expandable member and withdrawn proximally as taught by Abrams.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a constricting device formed as a wrap 142 that is withdrawn proximally relative to a shaft disclosed in Kleiner [0121-0122]) for another known element (a constricting device formed of a wire 24 that is withdrawn proximally into a slot of a shaft as taught in Abrams) in the art to obtain the predictable result of maintaining an expandable member in a compressed state by a constricting device, wherein proximal retraction of the constricting device allows expansion of the expandable member (see MPEP § 2143.I.B), thus achieving the wrap being specifically “a single thread” and the single thread extends about the expandable member in the collapsed state.
Kleiner (FIG.21A-C in view of FIG.1) in view of Abrams (FIG. 2) remain silent to wherein a distal portion of the single thread extends about the expandable member “in the expanded state”.
However, Abrams further teaches that the number and placement of the ports and threads will enable a wide range of configurations for the device (see [0050]), such as permitting a proximal end of the expandable member to expand before expanding a distal end of the expandable member (see [0045], [0048]) such that a distal portion of the single thread extends about the expandable member in the collapsed state and the expanded state (see ‘Modified Abrams’ in the rejection of claim 1 above. If the proximal end expands first, the distal portion of the wire still contacts the expandable member in the expanded state).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the placement of the single thread of the constricting device taught by Kleiner (FIG. 21A-C in view of FIG. 1) in view of Abrams (FIG. 2) such that the proximal end of the expandable member expands before the distal end as taught by Abrams (such as by modifying the winding placement of the single thread, see ‘Modified Abrams’ above) for the purpose of designing the device for an application where it is desirable for the proximal end of the expandable member to expand before the other end (see [0048]), thus achieving wherein a distal portion of the single thread extends about the expandable member “in the expanded state”.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kleiner in view of Abrams as applied to claim 8 above, and further in view of Strecker (U.S. Patent No. 6,485,515).
Regarding claim 9, the modified system of Kleiner teaches the medical device of claim 8, but Kleiner is silent to “wherein the distal portion of the single thread includes one or more slip knots linking the single thread to the expandable member; and wherein application of the proximal force on the single thread breaks or untangles the one or more slip knots.”
However, Abrams teaches a medical device comprising a shaft (11, see FIG. 2) and a constricting device (32) formed of a single thread (24, see [0041-0044]), wherein the distal portion (32) of the single thread (24) includes one or more loops (see loops as best shown in FIG. 1 and [0043]: 32 is coiled about 34) linking the single thread (24) to the expandable member (34); and wherein application of the proximal force on the single thread breaks or untangles the one or more loops (see [0043-0044]: wire is retracted proximally into lumen as shown in FIG. 3. The retracted wire as shown in the lumen 14 in FIG. 3 is straight and therefore the loops are untangled to a straightened position in response to the proximal force applied when withdrawing the thread).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the constricting device disposed over the expandable member and withdrawn proximally as disclosed in Kleiner with the constricting device disposed over the expandable member wherein loops of the constricting device are untangled in response to withdrawing the constricting device proximally as taught by Abrams.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a constricting device formed as a wrap 142 that is withdrawn proximally relative to a shaft disclosed in Kleiner [0121-0122]) for another known element (a constricting device formed of a looping wire 24 that is withdrawn proximally into a slot of a shaft as taught in Abrams) in the art to obtain the predictable result of maintaining an expandable member in a compressed state by a constricting device, wherein proximal retraction of the constricting device allows expansion of the expandable member (see MPEP § 2143.I.B), thus achieving “wherein the distal portion of the single thread includes one or more” loops “linking the single thread to the expandable member; and wherein application of the proximal force on the single thread breaks or untangles the one or more” loops.
Kleiner in view of Abrams remain silent to the distal portion of the thread includes one or more “slip knots” and wherein application of the proximal force on the single thread breaks or untangles the one or more “slip knots”.
However, Strecker teaches a medical device (see FIG. 1) with a constricting device comprising a thread (see col. 6 lines 27-39: device 15 held in compressed position by 14 and see col. 6 lines 40-43: material 14 is a thread) disposed over an expandable member (15, see col. 7 lines 1-37, specifically lines 30-37: thread is released to allow device 15 to expand), wherein the thread (14) includes one or more slip knots (21, see col 6 lines 54-67: knots 21 in FIG. 1 and see col 3 lines 15-59: releasable knots, such as “slip knots”, are preferable to loops or other knots because the thread is more easily released so the compressed device is not twisted under the friction applied when pulling the thread. Thus, the knots as mentioned and defined in the disclosure are slip knots) linking the thread (14) to the expandable member (as described in col 3 lines 15-59 and at least col 6 lines 54-67 in relation to FIG. 1); and wherein application of the proximal force on the single thread (14) breaks or untangles the one or more slip knots (21, see col 3 lines 15-59 and at least col 6 lines 54-67).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to replace the loops of the constricting device linking the thread to the expandable member taught by Kleiner in view of Abrams with the slip knots as taught by Strecker for the purpose of facilitating the release of the expandable member from the compressed position applied by the constricting device thread while minimizing undesirable torque on the expandable member (see col 3 lines 15-59: releasable knots, such as “slip knots”, are preferable to loops or other knots because the thread is more easily released so the compressed device is not twisted under the friction applied when pulling the thread to release the device into expanded form), thus achieving the distal portion of the thread includes one or more “slip knots” and wherein application of the proximal force on the single thread breaks or untangles the one or more “slip knots”.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Kleiner in view of Abrams as applied to claim 1 above, and further in view of Lumauig (U.S. PGPUB No. 2015/0366690).
Regarding claim 21, Kleiner in view of Abrams teaches the medical device of claim 1, but Kleiner in view of Abrams remain silent to “wherein the slot includes a ramped surface.”
However, Lumauig teaches a medical device (see FIG. 3) with a wire (26, see [0034]: 26 is guidewire) extending through a slot (38), wherein the slot (38) includes a ramped surface (see [0034]: 38 described as a ramp).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the slot taught by the constricting device mechanism of Kleiner in view of Abrams to include a ramped surface as taught by Lumauig for the purpose of directing the distal end of the wire (see [0034]), thus achieving “wherein the slot includes a ramped surface.”
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Kleiner in view of Abrams as applied to claim 24 above, and further in view of Strecker (U.S. Patent No. 6,485,515).
Regarding claim 26, the modified system of Kleiner teaches the medical device of claim 24, but Kleiner is silent to “wherein a proximal portion of the single thread extends through the lumen, wherein the distal portion of the single thread includes a plurality of knots linking the single thread to the expandable member, and wherein application of the proximal force on the single thread breaks or untangles the plurality of knots in order from a proximalmost knot of the plurality of knots to a distalmost knot of the plurality of knots.”
However, Abrams teaches a medical device comprising a constricting device (wire 32 constraining expandable member 34, see FIG. 2) and a shaft (11), wherein the constricting device (32) includes a single thread (24, see [0041-0044]), wherein the shaft (11) includes a slot (26) proximal (rightward in FIG. 2) to the expandable member (34) and aligned with (see slot 26 in line with longitudinal axis of lumen and is therefore “aligned with” the lumen) the lumen (14), wherein a proximal portion (28) of the thread (32) extends through (see [0042-0043]: wire pulled into lumen via port 26) the lumen (14), wherein the distal portion (32) of the single thread (24) includes a plurality of turns (see ‘Modified FIG. 2’ below and [0043]: 32 “coiled” about 34 and thus comprises turns linking to the expandable member)
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linking the single thread (24) to the expandable member (34), and wherein application of the proximal force on the single thread (24) breaks or untangles the plurality of turns (see ‘Modified FIG. 2’ above and [0043-0044]: turns are unwound to expand device in response to a proximal force. Turns are untangled as shown in FIG. 3 where only the straight/ untangled wire remains after proximal force is applied.).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the constricting device disposed over the expandable member and withdrawn proximally as disclosed in Kleiner with the constricting device disposed over the expandable member in a plurality of turns, wherein the turns of the constricting device are untangled in response to withdrawing the constricting device proximally as taught by Abrams.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a constricting device formed as a wrap 142 that is withdrawn proximally relative to a shaft disclosed in Kleiner [0121-0122]) for another known element (a constricting device formed of a looping wire 24 comprising a plurality of turns that is withdrawn proximally into a slot of a shaft as taught in Abrams) in the art to obtain the predictable result of maintaining an expandable member in a compressed state by a constricting device, wherein proximal retraction of the constricting device allows expansion of the expandable member (see MPEP § 2143.I.B), thus achieving “wherein the shaft includes a slot proximal to the expandable member and aligned with the lumen, wherein a proximal portion of the thread extends through the lumen, wherein the distal portion of the thread includes a plurality of turns linking the thread to the expandable member, and wherein application of the proximal force on the single thread breaks or untangles the plurality of knots”.
Kleiner in view of Abrams (FIG.2) is silent to the thread including a plurality of “knots” instead of turns and untangling occurring “in order from a proximalmost knot of the plurality of knots to a distalmost knot of the plurality of knots”.
However, Abrams further teaches that the number and placement of the ports and threads will enable a wide range of configurations for the device (see [0050]), such as permitting a proximal end of the expandable member to expand before expanding a distal end of the expandable member (see [0045], [0048]) such that the untangling of turns occurs in order from a proximalmost turn of the plurality of turns to a distalmost turn of the plurality of turns (see ‘Modified Abrams’ in the rejection of claim 1 above. If the proximal end expands first, the proximalmost turn untangles first compared to the distalmost turn untangling first as shown in FIG. 2).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the placement of the single thread of the constricting device taught by Kleiner (FIG. 21A-C in view of FIG. 1) in view of Abrams (FIG. 2) such that the proximal end of the expandable member expands before the distal end as taught by Abrams (such as by modifying the winding placement of the single thread, see ‘Modified Abrams’ above) for the purpose of designing the device for an application where it is desirable for the proximal end of the expandable member to expand before the other end (see [0048]), thus achieving untangling occurring “in order from a proximalmost” turn “of the plurality of” turns “to a distalmost” turn “of the plurality of” turns.
Kleiner in view of Abrams remains silent to the thread including a plurality of “knots” instead of turns.
However, Strecker teaches a medical device (see FIG. 1) with a constricting device comprising a thread (see col. 6 lines 27-39: device 15 held in compressed position by 14 and see col. 6 lines 40-43: material 14 is a thread) disposed over an expandable member (15, see col. 7 lines 1-37, specifically lines 30-37: thread is released to allow device 15 to expand), wherein the thread (14) includes a plurality of knots (21, see col 6 lines 54-67: knots 21 in FIG. 1 and see col 3 lines 15-59: releasable knots, such as “slip knots”, are preferable to loops or other knots because the thread is more easily released so the compressed device is not twisted under the friction applied when pulling the thread. Thus, the knots as mentioned and defined in the disclosure are slip knots) linking the thread (14) to the expandable member (as described in col 3 lines 15-59 and at least col 6 lines 54-67 in relation to FIG. 1); and wherein application of the proximal force on the single thread (14) breaks or untangles the one or more slip knots (21, see col 3 lines 15-59 and at least col 6 lines 54-67).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to replace the turns of the constricting device linking the thread to the expandable member taught by Kleiner in view of Abrams with the slip knots as taught by Strecker for the purpose of facilitating the release of the expandable member from the compressed position applied by the constricting device thread while minimizing undesirable torque on the expandable member (see col 3 lines 15-59: releasable knots, such as “slip knots”, are preferable to loops or other knots because the thread is more easily released so the compressed device is not twisted under the friction applied when pulling the thread to release the device into expanded form), thus achieving the thread including a plurality of “knots” instead of turns.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Kleiner in view of Abrams as applied to claim 23 above, and further in view of Lumaig (U.S. PGPUB No. 2015/0366690).
Regarding claim 27, the modified system of Kleiner teaches the medical device of claim 23, but Modified Kleiner is silent to “wherein the slot includes a ramped surface”.
However, Lumauig teaches a medical device (see FIG. 3) with a wire (26, see [0034]: 26 is guidewire) extending through a slot (38), wherein the slot (38) includes a ramped surface (see [0034]: 38 described as a ramp).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the slot in the shaft taught by the constricting device of Modified Kleiner to include a ramped surface as taught by Lumauig for the purpose of directing the distal end of the wire (see [0034]), thus achieving “wherein the slot includes a ramped surface.”
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Kleiner in view of Abrams as applied to claim 24 above, and further in view of Piskun et al. (U.S. PGPUB No. 2011/0224494), hereinafter Piskun.
Regarding claim 28, the modified system of Kleiner teaches the medical device of claim 24, but Modified Kleiner is silent to “wherein the lumen is a first lumen, and the shaft further includes a second lumen isolated from the first lumen, wherein the first lumen is configured to couple to a pressure source, and wherein a proximal portion of the single thread extends through the second lumen.”
However, Piskun teaches a medical device (30, see Fig. 1b and [0052]: multi-lumen tube 30) with a shaft (33) and a lumen (36), wherein the lumen (36) is a first lumen (see Fig. 1b and [0052]: several lumens provided), and the shaft (33) further includes a second lumen (38) isolated (see Fig. 1b) from the first lumen (36), wherein the first lumen (36) is configured to couple to a pressure source (see [0052]: 36 described as lumen for ‘vacuum’ and therefore must be configured to couple to pressure source for applying vacuum), and wherein a proximal portion of a single thread (one of the wires 12, see FIG. 2a and [0054]: wire 12 actuated via lumen 38 and wires 12 extend proximally to handle) extends through the second lumen (38).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft disclosed in Modified Kleiner to include multiple lumens for housing device tools as taught in Piskun for the purpose of providing the user with individual control of each tool, such as the thread and suction device (see [0017]), thus achieving “wherein the lumen is a first lumen, and the shaft further includes a second lumen isolated from the first lumen, wherein the first lumen is configured to couple to a pressure source, and wherein a proximal portion of the single thread extends through the second lumen.”
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Kleiner in view of Abrams as applied to claim 29 above, and further in view of Lumaig (U.S. PGPUB No. 2015/0366690).
Regarding claim 30, the modified system of Kleiner teaches the medical device of claim 29, but Kleiner is silent to “wherein a proximal portion of the single thread extends through the lumen, wherein the slot extends into the lumen and includes a ramped surface, and wherein a distal portion of the single thread extends about the expandable member.”
However, Abrams teaches a medical device comprising a shaft (11, see FIG. 2) and a constricting device (32) formed of a single thread (24, see [0040-0044]) surrounding an expandable member (34). Abrams further teaches wherein a proximal portion (16, see FIG. 1) of the single thread (24) extends through the lumen (14), wherein the shaft (11) includes a slot (26) extending into (see [0042]) the lumen (14), and wherein a distal portion (32) of the single thread (24) extends about the expandable member (34).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the constricting device withdrawn proximally disclosed in Kleiner with the constricting device withdrawn proximally into the shaft slot and lumen as taught by Abrams.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a constricting device formed as a wrap 142 that is withdrawn proximally relative to a shaft disclosed in Kleiner [0121-0122]) for another known element (a constricting device formed of a wire 24 that is withdrawn proximally into a slot of a shaft as taught in Abrams) in the art to obtain the predictable result of maintaining an expandable member in a compressed state by a constricting device, wherein proximal retraction of the constricting device allows expansion of the expandable member (see MPEP § 2143.I.B), thus achieving “wherein a proximal portion of the single thread extends through the lumen, wherein the slot extends into the lumen, and wherein a distal portion of the single thread extends about the expandable member.”
Kleiner in view of Abrams remain silent to “the slot including a ramped surface”.
However, Lumauig teaches a medical device (see FIG. 3) with a wire (26, see [0034]: 26 is guidewire) extending through a slot (38), wherein the slot (38) includes a ramped surface (see [0034]: 38 described as a ramp).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the slot in the shaft taught by the constricting device of Kleiner in view of Abrams to include a ramped surface as taught by Lumauig for the purpose of directing the distal end of the wire (see [0034]), thus achieving “wherein the slot includes a ramped surface.”
Response to Arguments
Applicant's arguments filed 03/10/26 have been fully considered but they are not persuasive.
On pages 10-11, Applicant argues that the embodiment of Abrams that shows the proximal end of the expandable member expanding before the distal end requires two wires. Although the examiner agrees that the figure of Abrams FIG. 2B best shows the proximal expansion, FIG. 2B is merely one of the several configurations possible through modification of the positioning of ports and wires (see Abrams [0050]: “The number and placement of ports as well as wires may be varied as desired. The embodiments shown in FIGS. 2 and 2a-2b are merely examples of the wide range of configurations which may be embodied by the present invention.”). Thus [0050] of Abrams teaches that Fig.2a-b are non-limiting examples of the different wire and port configurations of the device in view of the entirety of the disclosure. Abrams also discloses that the proximal expansion can happen with one wire (see [0045]) and the port placement allows for individualized retraction of the constricting device (see [0048] & [0050]). Therefore, in view of Abrams entire disclosure, the examiner argues that a person of ordinary skill in the art would have found it obvious to modify the placement of the wire of the constricting device such that the expandable member expands first at a proximal end (see MPEP § 2123.I: “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art…”.). The examiner further argues there is a reasonable expectation of success for such a modification (FIGs. 2, 2a and 2b teach wires wound along specific paths through ports that achieve a certain expansion and therefore a person of ordinary skill in the art has several examples to mimic/experiment with to achieve any desired expansion of the expandable member).
Lastly, the examiner notes the word “comprising” in the preamble of the claim language. “Comprising” indicates that the composition must include the recited components, but also can include unrecited components (see MPEP § 2111.03 (I). In the instant case, a device with two wires can read on the claim as long as one “single” thread has application of a proximal force thereon to expand the proximal end of the expandable memebr). Therefore, the examiner argues that the embodiment of FIG. 2B of Abrams would still read on the claim language because the single thread (24b) expands the proximal end of the expandable member before the other end that is constrained by a separate thread.
Thus, the examiner was not persuaded by this argument and maintained the reference Abrams to teach the newly amended limitation.
Because no additional arguments were presented, the examiner has also maintained the depending claim rejections.
In order to expedite prosecution, the examiner has also provided an additional reference in the conclusion statement that is related to the newly amended limitation that was rejected in this action.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Amundson et al (U.S. Patent No. 5,484,449) teaches a medical device with an expandable member (50/34, see Fig. 14) held in a collapsed state by a single thread (52) wherein a proximal force retracts the single thread such that the proximal end of the expandable member expands first (see col 6 lines 9-56).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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