DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/19/25 has been entered.
Response to Amendment
Applicant has amended claim 40. Claims 40, 42-43, and 45-61 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 7-14 of Applicant’s Remarks, filed 12/19/25, with respect to the rejections of claims 40, 42-43, 45, 48-41, 54, 56, 58, and 60-61 under 35 U.S.C. 103 as being unpatentable over Kleiner in view of Reesemann, in further view of Kantrowitz, and in further view of Waller, of claims 46-47 and 53 in further view of Gray, of claims 52 and 55 in further view of Bickelhaupt, of claim 59 in further view of Leiboff, and of claim 57 in further view of Reed have been fully considered and are persuasive. Accordingly, the rejections have been withdrawn. However, upon further search and consideration, new grounds of rejection have been made as indicated below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 40, 42-43, 45, 48, 54, and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Offermann (US 2011/0159457 A1) in view of Wallace (US 2,898,917 A) and in further view of Reesemann (US 5,855,567 A).
Regarding claim 40, Offermann discloses a post-operative surgical site wound treatment device (Figs. 2-4, feat. 1; ¶0007 and 0063-0072), the device comprising: a housing (Figs. 3-4, feat. 29; ¶0068), the housing including: a distal end with an aperture in the distal end of the housing, wherein the aperture is outwardly tapered in the distal direction (Fig. 2, feat. 21; ¶0064 and 0068: distal section 21 may be tapered to allow for compressing/squeezing of sponge-like contact device 17); a channel extending form the aperture to an interior surface of the housing (13; ¶0068); and a pressure outlet (2; ¶0071-0072); a wound dressing, wherein the wound dressing is configured to transition between an expanded configuration and a compressed configuration (17; ¶0063-0064 and 0068), wherein at least a portion of the tapered aperture in the distal end of the housing has a lateral expanse that is larger than a lateral expanse of the wound dressing when the wound dressing is in the expanded configuration and the tapered aperture tapers to a smaller lateral expanse that is less than the lateral expanse of the wound dressing when the wound dressing is in the expanded configuration, such that the wound dressing is compressed as it passes through the tapered aperture (Figs. 2-4, feats. 17 and 21’ ¶0063-0064 and 0068); and a negative pressure source coupled with the pressure outlet, wherein the negative pressure source is configured to provide negative pressure within the wound by creating negative pressure within the channel (33; ¶0071-0072).
Offermann does not disclose that the housing includes a flange extending outwardly from the distal end of the housing, a spool configured to rotate relative to the housing, wherein at least a portion of the spool resides within the housing, or that the wound dressing is coupled with the spool such that rotation of the spool retracts the wound dressing from a wound.
Wallace teaches a surgical retention device (Figs. 1-6, feat. 10; Col. 1, line 54 – 31) comprising a flat, soft, pliable disk or flange (11) extending outwardly from the aperture (12) of a tube or housing (14) for inserting instruments into the body of a patient. Wallace teaches that such a flange advantageously allows surgical devices, such as the one taught by Offermann, to be removably anchored to a patient (Col. 1, lines 31-35). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device disclosed by Offermann so that the housing includes a flange extending outwardly from the distal end of the housing in order to anchor the housing to the patient as taught by Wallace.
Offermann in view of Wallace does not suggest a spool configured to rotate relative to the housing, wherein at least a portion of the spool resides within the housing, or that the wound dressing is coupled with the spool such that rotation of the spool retracts the wound dressing from a wound. In the above cited embodiments, Offermann discloses a pushing device integrated in the housing for advancing or retracting the wound dressing (Figs. 3-4, feat. 27; ¶0068-0069). Offermann further teaches an embodiment comprising a rotary device integrated into the housing for advancing or retracting the wound dressing (Fig. 5, feat. 35; ¶0073), but does not teach a spool as claimed.
Reesemann teaches a catheter management system (Figs. 1-2, feat. 12; Col. 3, line 60 – Col. 4, line 4) which advantageously maintains organized control of the proximal portion of a catheter (Col. 2, line 29 – Col. 3, line 20), which generally stays outside the patient’s body and may be cumbersome for clinicians to maintain control of (Col. 2, lines 1-28). The catheter management system comprises a spool residing within the housing and rotating relative to it (74; Col. 5, lines 19-32). The spool couples to the shaft of a catheter (86; Col. 5, lines 19-53) such that rotating the spool in a first direction winds the catheter shaft around the spool and rotating the spool in the opposite direction unwinds the catheter shaft and extends it away from the catheter management system (Col. 5, lines 19-32). The spool helps clinicians maintain control of the catheter shaft by winding up and storing the proximal portion of the catheter shaft (Col. 2, lines 37-41; Col. 3, lines 18-20; Col. 5, lines 19-53). Modifying the device suggested by Offermann in view of Wallace to include a spool attached to the wound dressing like the one taught by Reesemann integrated into the housing of Offermann, in a similar manner to the pushing device or rotary device taught by Offermann, would advantageously help clinicians maintain control of the wound dressing by winding up and storing the proximal portion of the wound dressing as taught by Reesemann. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Offermann in view of Wallace so that it includes a spool configured to rotate relative to the housing, wherein at least a portion of the spool resides within the housing, and so that the wound dressing is coupled with the spool such that rotation of the spool retracts the wound dressing from a wound in order to help clinicians maintain control of the wound dressing by winding up and storing the proximal portion of it as taught by Reesemann.
Regarding claim 42, Offermann in view of Wallace and in further view of Reesemann suggests the device of claim 40. Reesemann teaches a side port (Fig. 2, feat. 42; Col. 4, line 63 – Col. 5, line 9) in fluid communication with a main channel (Fig. 2, feat. 40; Col. 4, lines 34-42), which corresponds to the channel of Offermann (Offermann: Figs. 2-4, feat. 13; ¶0068), which contains a catheter (14), which corresponds to the wound dressing of Offermann (Offermann: Figs. 2-4, feat. 17; ¶0063-0072). The side port (Fig. 2, feat. 42) is proximal relative to the channel (40) and spool (74). Because the side port is in fluid communication with the channel, it would be able to provide negative pressure to the wound dressing and wound in a similar manner to the pressure outlet of Offermann (Figs. 2-4, feat. 2; ¶0071-0072). Therefore, Offermann in view of Wallace and in further view of Reesemann further suggests that the pressure outlet is disposed proximal to the channel.
Regarding claim 43, Offermann in view of Wallace and in further view of Reesemann suggests the device of claim 40, and Offermann further discloses that the pressure outlet (Figs. 2-4, feat. 2; ¶0071-0072) is disposed on the channel (Figs. 2-4, feat. 13; ¶0068).
Regarding claim 45, Offermann in view of Wallace and in further view of Reesemann suggests the device of claim 40. As discussed above, Wallace teaches a flat, soft, pliable disk or flange (Figs. 1-6, feat. 11) extending outwardly from the aperture (12). Therefore, Offermann in view of Wallace and in further view of Reesemann further suggests that the flange is disposed about the aperture.
Regarding claim 48, Offermann in view of Wallace and in further view of Reesemann suggests the device of claim 40. Reesemann further teaches that the spool (Fig. 2, feat. 74; Col. 5, lines 19-32) comprises a rotating drum, or column, (78) that the catheter shaft (86) is wound and unwound from based on the rotation of the drum (Col. 5, lines 19-32). The proximal end of the catheter shaft protrudes into a channel in the drum (Fig. 2, feat. 89; Col. 5, lines 45-53 – please note, the figure labels this as 89, while the text labels this as 88) to connect to the luer fitting (76) and enters the channel (Fig. 2, feat. 40) at its distal end (Fig. 2, feat. 90; Col. 5, liens 45-53). Therefore, Offermann in view of Wallace and in further view of Reesemann further discloses that the channel is within a column of the spool.
Regarding claim 54, Offermann in view of Wallace and in further view of Reesemann suggests the device of claim 40. As discussed above, Reesemann further teaches that rotating the spool in one direction retracts the catheter, while rotating it in the other direction extends the catheter (Col. 5, lines 19-32). Therefore, Offermann in view of Wallace and in further view of Reesemann further suggests that rotating the spool in a first direction relative to the housing translates the wound dressing toward the housing and rotating the spool in a second direction opposite the first direction translates the wound dressing away from the housing.
Regarding claim 58, Offermann in view of Wallace and in further view of Reesemann suggests the device of claim 40. Offermann further discloses that the distal section of the housing defining the aperture and channel may be tapered (¶0064 and 0068) to allow for compressing or squeezing the wound dressing (17). Therefore, Offermann in view of Wallace and in further view of Reesemann further suggests that at least a portion of the channel is tapered.
Claims 46-47 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Offermann in view of Wallace, in further view of Reesemann, and in further view of Gray et al. (US 6,086,008 A).
Regarding claim 46, Offermann in view of Wallace and in further view of Reesemann suggests the device of claim 40, but does not disclose that an outer surface of the spool comprises a torque grip. Regarding claim 47, Offermann in view of Wallace and in further view of Reesemann is further silent with respect to the torque grip comprises a depression, a protuberance, or both.
Gray teaches a catheter reel apparatus for facilitating one-person, single handed control of catheter movement (Fig. 7; Col. 1, lines 44-63) comprising a reel (Figs. 1 and 7, feat. 5; Col. 3, lines 15-44) and a housing (18; Col. 4, lines 29-36). The reel has a protruding knob which can be turned with one hand to extend or retract the catheter (24; Col. 2, lines 14-22; Col. 4, lines 44-53). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Offermann in view of Wallace and in further view of Reesemann so that an outer surface of the spool comprises a torque grip, with respect to claim 46, and so that the torque grip comprises a depression, a protuberance, or both, with respect to claim 47, so that the spool may be turned with one hand as taught by Gray.
Regarding claim 53, Offermann in view of Wallace and in further view of Reesemann suggests the device of claim 40, but does not disclose a groove in the spool, the housing, or both enabling the spool to rotate relative to the housing.
Gray teaches a catheter reel apparatus for facilitating one-person, single handed control of catheter movement (Fig. 7, Col. 1, lines 44-63) comprising a reel (Figs. 1, 2, and 7, feat. 5; Col. 3, lines 15-44) and a housing (18; Col. 4, lines 29-36). On its housing facing surface, the reel has a groove (Figs. 2 and 11, feat. 26; Col. 5, lines 14-31) that the ridge of a stop dog (Figs. 7 and 13, feat. 20; Col. 4, lines 29-36; Col. 5, lines 14-31) coacts with. The stop dog further rides in a stop dog groove (Figs. 7 and 13, feat. 21; Col. 4, lines 29-36; Col. 5, lines 14-31) in the housing (18). The grooves in the reel (26) and housing (21) in conjunction with the stop dog (20) allow the spool to rotate relative to the housing until the catheter being extended or retracted is at its maximum or minimum acceptable length (Col. 4, lines 29-36; Col. 5, lines 14-31). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Offermann in view of Wallace and in further view of Reesemann so that it comprises a groove in the spool, the housing, or both enabling the spool to rotate relative to the housing in order to allow the spool to rotate until the wound dressing being extended or retracted is at its maximum or minimum acceptable length as taught by Gray.
Claims 49-51, 56, and 60-61 are rejected under 35 U.S.C. 103 as being unpatentable over Offermann in view of Wallace, in further view of Reesemann, and in further view of Kleiner (US 2015/0148785 A1).
Regarding claims 49-51 and 56, Offermann in view of Wallace, in further view of Reesemann, and in further view of Kleiner suggested the device of claim 40, but does not disclose that the device further comprises a catheter, with respect to claim 49, comprising one or more perforations between an outer surface of the catheter and an inner surface of the catheter, with respect to claim 50, wherein the one or more perforations are disposed about the distal portion of the catheter, with respect to claim 51, or that the wound dressing is disposed about a distal portion of a catheter, with respect to claim 56.
Kleiner teaches a wound treatment device (Figs. 1-4, feat. 10; Figs. 21A-C, feat. 140; ¶0009, 0084-0093, 0099, and 0120-0122) comprising a catheter (Fig. 1, feats. 22 and 30; ¶0085-0086) comprising perforations between the inner and outer surfaces of the catheter and disposed about the distal portion of the catheter (Figs. 1-4, feat. 26; ¶0085). The catheter further comprises a sponge, or wound dressing, (14; ¶0084) mounted on the distal portion of the catheter. Kleiner teaches that mounting the wound dressing sponge on a catheter with distal perforations advantageously allows for fluid drainage from wounds up to a depth within the patient equal to the length of the catheter (¶0084-0086), such as wounds within the GI tract of the patient (¶0099). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Offermann in view of Wallace and in further view of Reesemann so that the wound dressing of Offermann is mounted on the distal portion of a catheter like the one taught by Kleiner, resulting in the device further comprising a catheter, with respect to claim 49, comprising one or more perforations between an outer surface of the catheter and an inner surface of the catheter, with respect to claim 50, wherein the one or more perforations are disposed about the distal portion of the catheter with respect to claim 51, or that the wound dressing is disposed about a distal portion of a catheter, with respect to claim 56, in order to allow for fluid drainage from wounds deep within a patient, such as wounds within the GI tract, as taught by Kleiner.
Regarding claims 60-61, Offermann in view of Wallace and in further view of Reesemann suggests the device of claim 40. Reesemann further teaches a Luer fitting in the center of the spool and extending through the housing (Fig. 2, feat. 76; Col. 5, lines 19-32) which fluidly couples to the proximal end (Fig. 2, feat. 89; Col. 5, lines 45-53 - please note, the figure labels this as 89, while the text labels this as 88) of a catheter shaft (86), and that the luer fitting may be used to inflate or deflate balloon catheters (Col. 5, lines 19-53), thereby being in two-way fluidic communication with a catheter. However, Reesemann does not provide motivation for including a catheter in the wound dressing device of Offermann in view of Wallace and in further view of Reesemann.
As discussed above, Kleiner teaches a wound treatment device (Figs. 1-4, feat. 10; Figs. 21A-C, feat. 140; ¶0009, 0084-0093, 0099, and 0120-0122) comprising a catheter (Fig. 1, feats. 22 and 30; ¶0085-0086) comprising perforations between the inner and outer surfaces of the catheter and disposed about the distal portion of the catheter (Figs. 1-4, feat. 26; ¶0085). The catheter further comprises a sponge, or wound dressing, (14; ¶0084) mounted on the distal portion of the catheter. Kleiner teaches that mounting the wound dressing sponge on a catheter with distal perforations advantageously allows for fluid drainage from wounds up to a depth within the patient equal to the length of the catheter (¶0084-0086), such as wounds within the GI tract of the patient (¶0099). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Offermann in view of Wallace and in further view of Reesemann so that the wound dressing of Offermann is mounted on the distal portion of a catheter like the one taught by Kleiner, resulting in a device in which the spool further comprises a source opening on an outer surface of the spool, a catheter opening on the inner surface of the spool, and a conduit between the source opening and the catheter opening, and wherein a terminus of the proximal portion of a catheter couples to the catheter opening of the spool, with respect to claim 60, and so that the catheter and the source opening are in two-way fluidic communication, with respect to claim 61, in order to allow for fluid drainage from wounds deep within a patient, such as wounds within the GI tract, as taught by Kleiner.
Claims 52 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Offermann in view of Wallace, in further view of Reesemann, and in further view of Bickelhaupt et al. (US 4,713,059 A).
Regarding claim 52, Offermann in view of Wallace and in further view of Reesemann suggests the device of claim 40, but does not disclose a flange in the spool, housing, or both enabling the spool to rotate relative to the housing.
Bickelhaupt teaches a catheter dispenser (Fig. 1, feat. 11; Col. 2, lines 43-52) comprising an upper section (19) and a base (13) which house a reel (15). The base comprises a central shaft (Fig. 4, feat. 31; Col. 2, line 56 – Col. 3, line 7) comprising a flange (35) and a resilient retainer on the shaft below the flange (53; Col. 3, lines 8-18). The reel (Fig. 4, feat. 15) comprises a central opening that snap fits over the base central shaft flange (35) so that the resilient retainer (53) engages the reel enough to prevent it from demounting from the base, while allowing it to rotate (Col. 3, lines 8-18). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Offermann in view of Wallace and in further view of Reesemann so that it comprises a flange in the spool, housing, or both enabling the spool to rotate relative to the housing in order to prevent the spool from demounting from the housing as taught by Bickelhaupt.
Regarding claim 55, Offermann in view of Wallace and in further view of Reesemann suggests the device of claim 40, but does not disclose but do not disclose that at least a portion of the spool contacts an inner surface of the housing when the spool rotates within the housing.
As discussed above, Bickelhaupt teaches a catheter dispenser (Fig. 1, feat. 11; Col. 2, lines 43-52) comprising an upper section (19) and a base (13) which house a reel (15). The base comprises a central shaft (Fig. 4, feat. 31; Col. 2, line 56 – Col. 3, line 7) comprising a flange (35) and a resilient retainer on the shaft below the flange (53; Col. 3, lines 8-18). The reel (Fig. 4, feat. 15) comprises a central opening that snap fits over the base central shaft flange (35) so that the resilient retainer (53) engages the reel enough to prevent it from demounting from the base, while allowing it to rotate (Col. 3, lines 8-18). Because the base engages the reel via the resilient retainer, the reel and the base are in contact while the reel rotates. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Offermann in view of Wallace and in further view of Reesemann so that at least a portion of the spool contacts an inner surface of the housing when the spool rotates within the housing in order to prevent the spool from demounting from the housing as taught by Bickelhaupt.
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Offermann in view of Wallace, in further view of Reesemann, and in further view of Reed et al. (US 2012/0123359 A1).
Regarding claim 57, Offermann in view of Wallace and in further view of Reesemann suggests the device of claim 40, but does not disclose a mesh disposed about the wound dressing.
Reed teaches a negative pressure wound drainage device (Figs. 1-3; ¶0016-0027) comprising a vacuum tube (30; ¶0019) with perforations (400; ¶0024) surrounded by an absorbent material wound dressing (300; ¶0022-0027). Reed teaches that the absorbent material may have a mesh disposed about its inner diameter (Fig. 3, feat. 550) in order to support the absorbent material and prevent occlusion of the application of vacuum (¶0027). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Offermann in view of Wallace and in further view of Reesemann so that it further comprises a mesh disposed about the wound dressing in order to support it and prevent occlusion of the application of vacuum as taught by Reed.
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Offermann in view of Wallace, in further view of Reesemann, and in further view of Leiboff et al. (US 2006/0241689 A1).
Regarding claim 59, Offermann in view of Wallace and in further view of Reesemann suggests the device of claim 40, but does not disclose that the wound dressing is coupled with a tether.
Leiboff teaches wound dressings (Fig. 1; ¶0039; Fig. 6; ¶0047) with features that enable easy removal of the dressing (¶0010-0011). Leiboff teaches that the dressings may comprise a free end (Fig. 1, feat. 13; ¶0039) made of the same material as the dressing, or a loop of a different material (Fig. 6, feats. 44 and 48; ¶0047), which are maintained outside of the wound and can be pulled on to remove the dressing (¶0047). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Offermann in view of Wallace and in further view of Reesemann so that the wound dressing is coupled with a tether in order aid in the removal of the dressing as taught by Leiboff.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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