DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments filed 10/28/2025 have been entered. As applicant cancelled claim 12, the drawing objection has been withdrawn. Applicant’s amendments are mostly directed toward previous limitations from dependent claims being brought into claim 1. However there is a new limitation of “the lumina having the smaller cross sectional area is configured to supply a flushing solution through the lumen”. The rejection has been updated to include this new limitation.
Response to Arguments
Applicant's arguments filed 10/28/2025 have been fully considered but they are not persuasive. Applicant argues that the cited prior art fails to teach the amended claim 1, namely the limitation that the probe is a biluminal tube. Applicant argues that A) Cornet teaches away from biluminal implementation, B) Cornet constitutes an impermissible base reference, and C) neither Cornet of Goddard teach, disclose, or suggest all claim elements.
Regarding A), applicant argues that Cornet is directed toward unidirectional vacuum driven fluid extraction in a sealed wound environment, where Cornet requires system tissue collapse and cavity compression under sustained vacuum to function as intended, [which is] directly antithetical to bi-directional fluid transport. Further providing Goddard’s teachings would substantially undermine Cornet’s negative pressure requirement due to Goddard requiring balanced bidirectional flow. Further applicant argues that Cornet is directed toward treatment through a single incision in cavities and between tissue layers, whereas Goddard operates in naturally hollow organs where the pressure equilibrium prevents organ distention. As such the combination would not have been obvious. The examiner respectfully disagrees. While the examiner does agree with the assertation that Cornet uses suction and is placed within single incision between tissue layers Cornet repeatedly disclose that fluid is being removed from said treatment area (see abstract). Further Goddard (See also Goddard abstract) teaches that the dual lumen provides both suction and irrigation to a site, where “the target area may be any location…site of a recent medical procedure that may result in particles” and further teaches that the device “may be used to remove particles or other objects from any area of the body” (both quotes from para. 0024, provided in the previous rejection (office action dated 07/28) of claim 7). Further, regarding the pressure equilibrium argument, the examiner notes that per paragraph 0047 of Goddard, the flow rate of the fluid may be balanced with the vacuum flow rate…rates can be substantially equal but not need be exactly equal. The examiner notes that per this citation, the flow is balanced to the vacuum rate to prevent harm to patient (for example collapsing of the kidney due to lack of fluid), not that the vacuum rate is changed to meet the fluid introduction rate. Therefore as Cornet teaches a device for removing fluid with suction from a wound, and Goddard teaches the use of a dual lumen system to introduce fluid to a wound site (site of recent medical procedure) to wash out said site and remove fluid from said site through suction, it would be obvious to modify the device of Cornet by the teachings of Goddard (as presented in the previous office action). Said combination would aid in the cleaning out of a wound site (irrigation breaking up particles caused by a procedure) and suction out fluid from the wound. As such the arguments are found to be nonpersuasive. Based on this assertation by the examiner, argument B) is found to be nonpersuasive, as argument B) relied on not combining the Cornet and Goddard references. Argument C) is also found to be nonpersuasive as the arguments provided in C) are directed to the biluminal tube not being taught by the prior art due to differences between Cornet and Goddard. As detailed above, the examiner upholds the rejection of Cornet in view of Goddard and as such C) is nonpersuasive.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1,2,5,6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cornet in view of Goddard, McCormick, and Looper, where each prior art was provided in the previous office action.
Regarding Claim 1, Cornet discloses
A probe system (figure 1-5B) for endoluminal negative pressure therapy (para. 0032) comprising a probe tube (106); a probe body connected with the probe tube (probe is interpreted to be drainage manifold (102)) the probe body comprising: a basic body with a basic body outer wall and an outer side (interpreted as tubular body, see annotated figure below); and inner lumen (Fig. 5A , lumen starting at (586)); an opening which leads from the inner lumen through the basic body outer wall to the outer side of the basic body (see annotated figure 5B below); and a plurality of rod-form structures and/or a lamella-form structure on the outer side of the basic body (rod form structures (552)).
Cornet further discloses wherein the plurality of rod-form structures and/or lamella-form structure extend perpendicularly to the basic body outer wall. The examiner notes that as seen in figure 5A and 5B, the structures (552) are seen extending outwardly from a flat face of the probe and are therefore interpreted as extending perpendicularly from the outer wall of the body. Additionally, per figure 5B it can be seen that the outer body has four flat sides (not labeled but seen in the figure as the top, bottom, left, and right of the body and seen to be at right angles from one another), where the structures are extending from the flat faces and therefore also extending perpendicularly from the device (extending from the top face and right face). Further per paragraph 0067, the elongate members may form an angle (not shown) relative to the support wherein the angle may reduce trauma upon withdrawal.
Cornet further discloses wherein the rod-form structures and/or lamella-form structure are disposed on the basic body outer wall. The examiner notes that as seen in figure 5B, the elongate members (552) are seen to be disposed around the edge of the. Further, per para. 0067, Cornet discloses that any number of elongate members may be used to suit a particular application. Further, the examiner points to figure 2A showing a modified embodiment of the one seen in figure 5A-B. Figure 2A still requires the same probe tube (105 see para. 0039) and elongate member structures (252), however the elongate members are just in a different shape/configuration. The examiner notes that as seen in figure 2A, the elongate members completely surround the probe body and are thus interpreted to be disposed along the probe body. However, there is no disclosure that the elongate members are placed helically. Per MPEP Section 2144.04 VI C, it has been held that obviousness exists when shifting the position of a component would not have modified the operation of the device. Therefore, as Cornet discloses a plurality of elongate members placed around a body where per paragraph 0067 the elongate members provided are disclosed to be variable (i.e. any number of members, may form any angle), it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the elongate members of Cornet to be disposed helically. The examiner notes that doing do would not have modified the operation of the device as the elongate members would still be disposed along the tube and would still be capable of performing their intended function of draining fluid. As such, said modification is obvious, as detailed in the same paragraph above.
The examiner notes that as detailed under the rejection of claim 1, Cornet discloses that the device is configured to be used for insertion into a patient and draining of the wound via suction (See fig. 1, para. 0032). As such Cornet is interpreted to function as an aspiration catheter. However Cornet does not teach that the tube comprises two lumens.
Goddard teaches an aspiration catheter and is thus considered analogous to the claimed invention. Goddard teaches that the device comprises a tube body (108, see figures 1-3) configured to enter a patient, where the tube body has two lumens (112 and 114, see figure 2, seen to be separated by a straight wall). Per paragraph 0034-0035, the lumens may be any size or shape. Goddard further teaches that for effective treatment, the lumens are configured to apply suction, and apply fluid, where 112 is taught to be the supply lumen (para. 0042, 0044), and 114 is taught to be the suction lumen (para. 0043), see also abstract. While the embodiment of Goddard is directed to the kidneys, Goddard teaches that the device is broadly used for removing particles from the body, and thus not limited to the kidneys (para. 0023,0024). Therefore as a means flush removable material (abstract, para. 0023) and separately remove that material, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the entire flow path of Cornet with a dual lumen catheter such that the wound debris can be flushed out in addition to suctioned out, as it is known in the art to provide aspiration catheters with dual lumens to achieve said treatment.
The examiner notes that as detailed in the directly previous paragraph, Goddard teaches that the lumens may be any size or shape and where the lumens 112 and 114 may have a different cross sectional size (para. 0035), thus having different cross sectional areas per the claimed limitation. The examiner notes however that it is not specifically disclosed that the smaller lumen is the fluid supplying lumen (Goddard discloses that either lumen may supply fluid or suction (para. 0035). However, as it was found that the lumens of the combination of Cornet and Goddard may be any suitable size, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide fluid through the smaller lumen, as it was found that the lumens may be different sizes and fluid may be supplied through either lumen. As such there is a finite number of obvious combinations that one of ordinary skill in the art would reasonably apply ([1] the larger lumen for suction and the smaller lumen for fluid or [2] the larger lumen for fluid and the smaller lumen for suction). Either of these combinations would achieve the predictable result of having one lumen for fluid and one lumen for suction. As such, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use to smaller lumen of the combination of arts for fluid irrigation.
Cornet and Goddard fail to teach wherein the cross sections of the two lumina of the biluminal tube are circular. The examiner notes that as detailed above, the lumen of Goddard are taught to be any suitable size (para. 0034), where para 0035, describes the shapes in figure 2 as semicircular. The examiner notes that while semicircular may read to the claimed limitation of circular, in an effort to achieve compact prosecution, prior art reference McCormick is relied upon.
McCormick teaches an aspiration catheter and is thus considered analogous to the claimed invention. McCormick teaches that catheter is a dual lumen catheter (para. 0056, Fig. 2C), where lumens (28, 34) are both seen to be circular. The examiner notes that per MPEP 2144.04 IV B, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). Therefore as Goddard teaches that dual lumens in an aspiration catheter may be any suitable shapes, and McCormick teaches that dual lumen catheters are known to be functional with two circular cross section lumens, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the lumen shape of Cornet and Goddard to have both lumens be fully circular, as an obviousness change in shape.
The combination of prior arts fails to disclose the system further comprising a plug that closes the inner lumen of the basic body on a side opposite the connection site to the probe tube.
Looper teaches a catheter device and is thus considered analogous to the claimed invention. Looper teaches that said catheter device may comprise a weighted element in the form of plug (344, see figure 3) for attaching to the distal end of the catheter (para 0029), where the distal end is the insertion end (abstract). Looper teaches that said plug is connected with the distal end such as to weight the distal end, helping to facilitate orientation of the device and minimizing likelihood of direct contact within the patient (para. 0030). See also claim 7 of Looper. Therefore as Looper teaches that weighting the insertion end of an insertable catheter allows for easier orientation and minimizes the risk of direct contact upon insertion, where said weighting is done via a plug, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a weighting plug in the distal end of the device of Cornet.
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Regarding Claim 2, Cornet, Goddard, McCormick and Looper teach
The probe system of Claim 1, wherein the basic body and the probe tube are implemented integrally or are connected with one another under material closure (Cornet, see connected via transitional connector (104)).
Regarding Claim 5, Cornet, Goddard, McCormick and Looper teach
The probe system of Claim 1, wherein the rod-form structures and/or lamella-form structure are flexible and/or elastic. Per Cornet para. 0066, the elongate members of Cornet figure 5A-B are disclosed to be moveable relative to the support on the body (see also abstract). As additionally seen in figure 5B, the members are bending in addition to being moveable, thus indicating flexibility.
Regarding Claim 6, Cornet, Goddard, McCormick and Looper teach
The probe system of Claim 1, wherein a length of rod-form structures and/or lamella-form structure is varied (Cornet para. 0070). Per paragraph 0070, the members comprise a trimmable tip allowing for the members to be cut to a desired length without exposing the reinforced portion. Should applicant assert that this does not read to the limitation that the length is varied, the examiner points to MPEP Section 2144.01 IV B, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). The examiner notes that therefore as long as the reinforced portion of the member is not exposed, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the trimmable tip of members to be cut to different lengths as desired, as it would have no apparent function on the operation of the device (reinforced portion not interfered with). As such the members would have different lengths from one another.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781