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 .
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 3, 5-7, 9, 10, 16-19 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Goble, E. Marlowe et al. (US 20040030281 A1) in view of Razavi; Mahmood et al. (US 20220080176 A1).
Regarding claim 1, Goble discloses a dual-port surgical drain (¶ [0003], methods and systems for concurrent aspiration and infusion of a wound site; ¶ [0018] Shown in FIG. 1 … System 35 is applied to a knee 25 of a patient to treat a surgical wound that would result from, for example, a total knee arthroplasty surgery);
comprising: a surgical drain tube (¶ [0020] Aspiration catheter 15 comprises a proximal section 50, an opposing distal section 52, and a middle section 54 extending therebetween … A plurality of spaced apart side ports 11 extend through aspiration catheter 15 at distal section 52 so as to communicate with second lumen 56; ¶ [0026], Similarly, a flow control 6, pump 4, and aspiration reservoir 3 are operably coupled with proximal section 50 of aspiration catheter 15; ¶ [0032], As the syringe plunger is pushed out of the syringe barrel by the spring, a relative vacuum is produced which causes fluid to be sucked into aspiration catheter 15 through ports 11, 27 and into the syringe barrel);
configured to drain fluid from a surgical site (¶ [0018], While FIG. 1 demonstrates use of one embodiment of integrated infusion and aspiration system 35 for a knee, it is understood that the present invention can be used for any internal body wound created by surgery, trauma, or disease); and
a treatment tube (¶ [0019], Infusion catheter 10 comprises a proximal section 40, an opposing distal section 42, and a middle section 44 (see FIG. 2) extending therebetween … Infusion catheter 10 bounds a first lumen 46; ¶ [0023] Infusion catheter 10 travels distally within second lumen 56 and exits aspiration catheter 15 through end port 27 at distal end tip 12; ¶ [0035], The dose of infusion solution passes through infusion catheter 10 and out through ports 16, 26 to one side of the wound site);
wherein the surgical drain tube and treatment tube are configured for passage through skin (¶ [0024], only a single tract through the skin is required to pass both catheters 10 and 15 from an extracorporeal site to the internal wound site; ¶ [0035], during operation catheter assembly 20 is inserted through a single incisions 62 in the skin so that at least a portion of ports 11, 27 and 16, 26 are positioned on opposing sides of an internal wound site).
Goble does not explicitly disclose first and second ports configured to form a sealed passage through skin for the surgical drain tube and treatment tube. Razavi discloses a vascular access system (¶ [0003], [0057], [0062] FIGS. 1A-1D … luminal access system 100);
comprising a dual-port surgical drain (¶ [0062] FIGS. 1A-1D … The luminal access system 100 can include a port 102; ¶ [0072] FIGS. 2A-2C … luminal access system 200; ¶ [0084] FIG. 2A … The luminal access system 200 can include a plurality of conduits 260, each with valves 280 near each conduit's proximal end and distal end);
comprising: a first port configured to form a sealed passage through skin for a first tube (¶ [0074] The gateway element 250 can be attached to one or more conduits 260; ¶ [0077], The gateway element 250 can be passively expanded. The gateway element 250 can be expanded by insertion of the conduits 260, a mechanical expander, or other medical tools; ¶ [0085] FIG. 2B … The conduits 260 are connected to luer lock tubing 262. The conduit 260 are attached to tubing 262 through the proximal valves 280; ¶ [0087] In some embodiments, a luminal access system 200 may include a single, or a plurality of conduits 260 that can be used for therapeutic infusions (e.g., chemotherapy or other long-term infusion) and/or blood draws);
comprising a proximal portion configured for implantation within a subject to drain fluid from a surgical site (¶ [0085] FIG. 2B … The conduits 260 are connected to luer lock tubing 262. The conduit 260 are attached to tubing 262 through the proximal valves 280; ¶ [0086] FIG. 2C … A guidewire 290 can be used to replace the conduit 260. The guidewire 290 can be threaded through the target conduit 260 into the target vessel, the conduit 260 removed, a new conduit 260 (including one or more valves 280 as noted above) inserted over the guidewire 290 into the gateway element 250); and
a second port configured to form a sealed passage through skin for a second tube (¶ [0074], The gateway element 250 can be otherwise associated with one or more conduits 260; ¶ [0084] FIG. 2A … The luminal access system 200 can include a plurality of conduits 260).
Razavi describes how to interface one or more tubes with a sterile interface through a patient’s skin (¶ [0084] FIG. 2A … The cap 272 can be a re-sealable barrier in other embodiments, such as subcutaneous embodiments, and accessed with aseptic techniques to ensure sterility; ¶ [0085] FIG. 2B … The cap 272 is removed … The cap can be screwed on and off with a technique to maintain sterility). One would be motivated to modify Goble with Razavi’s first and second sealed ports since Goble calls for passing a pair of tubes through a patient’s skin but does not describe how to prevent pathogens from entering the incision (¶ [0050] FIG. 7 … This integral connection between catheters 10 and 15 enables catheter assembly 70 to be inserted through a single incision in the skin). Therefore, it would have been obvious to modify Goble with Razavi’s first and second ports in order to prevent an infection at the incision where the tubes enter the patient’s body.
Regarding claims 3, 7 and 24, Goble discloses that the treatment reservoir contains an antibiotic or antiviral compound (¶ [0027], the infusion solution can contain, separately or in combination, an analgesic agent, an anesthetic agent, an antibiotic, an antiseptic, an anticoagulant, or an anti-inflammatory);
further comprising a vacuum source connected to the surgical drain tube (¶ [0032], As the syringe plunger is pushed out of the syringe barrel by the spring, a relative vacuum is produced which causes fluid to be sucked into aspiration catheter 15 through ports 11, 27 and into the syringe barrel);
wherein the treatment tube has a distal end in fluidic communication with a treatment reservoir (¶ [0026], FIG. 1, flow control system 19 comprises … medication reservoir 1 … Reservoirs 1 and 3 can comprise a flexible bag, such as an IV bag, a syringe barrel, or any other conventional hard of soft sided container adapted to hold a fluid; ¶ [0030], medication reservoir 1 is a syringe barrel);
Regarding claim 5, Goble discloses that the surgical drain tube collects surgical drain fluid comprising a biomarker selected from the group consisting of tumor cells, immune cells, bacterial cells, viral host cells, donor organ cells, microvascular cells, DNA, cell- free DNA (cfDNA), cell-free RNA (cfRNA), circulating tumor DNA (ctDNA), messenger RNA, exosomes, proteins, and hormones (¶ [0018], FIG. 1 … System 35 is applied to a knee 25 of a patient to treat a surgical wound that would result from, for example, a total knee arthroplasty surgery … the present invention can be used for any internal body wound created by surgery, trauma, or disease).
Goble does not explicitly state that the collected fluid comprises one of the claimed biomarkers. However, Goble collects fluid from a surgical wound after knee surgery (¶ [0018]). The surgical wound will necessarily contain blood or blood plasma, which contains DNA from the patient’s blood cells and circulating tissue that has been disrupted or fragmented during surgery.
Regarding claims 9 and 10, Goble lacks first and second valves. Razavi discloses that the first port comprises a first valve and the second port comprises a second valve (¶ [0084] FIG. 2A … The luminal access system 200 can include a plurality of conduits 260, each with valves 280 near each conduit's proximal end and distal end. The valve 280 can be a one-way valve. Each conduit 260 can have one or more valves 280).
Razavi preserves the sterility of a port by preventing pathogens from entering the patient’s body (¶ [0084], [0085]). Regarding the rationale and motivation to modify Goble with Razavi’s valves, see the discussion of claim 1 above.
Regarding claims 6 and 16-18, Goble collects fluid from the patient’s surgical wound which inherently contain various biomarkers (¶ [0018], FIG. 1 … System 35 is applied to a knee 25 of a patient to treat a surgical wound that would result from, for example, a total knee arthroplasty surgery … the present invention can be used for any internal body wound created by surgery, trauma, or disease).
To clarify, blood and wound fluid comprise a mixture of plasma, blood cells and tissue fragments.
Goble does not explicitly disclose that the first port collects a tumor cell, cfDNA, interleukins, TNF, matrix metalloproteinase or a mutated nucleic acid, or that the biomarker is a ratio of circulating tumor cells to cfDNA. However, this claim is drawn to a device and not necessarily a method of using it, or the contents received in the first port. Depending on the patient’s physiology and disease status, their blood and wound fluid will contain various biomarkers and cells. For example, a patient with cancer will have blood or tissue that contain cancer cells. When the patient’s tissue is disrupted during knee surgery, cancer cells will enter the bloodstream. Goble suggests that wound fluid may include cells related to edema (¶ [0007], the need to concurrently address edema, or fluid build-up and swelling, at the wound site; ¶ [0027], concurrent prophylactic treatment for infection and treatment to reduce swelling).
Goble’s system is fully capable of collecting any cellular material, biomarker or substance that enters the patient’s blood and wound fluid. Therefore, depending on a patient’s disease state, the blood and wound fluid will contain a tumor cell, cfDNA or any of the other biomarkers.
Regarding claim 19, Goble discloses a system that collects surgical fluid (¶ [0007], [0018], [0027]). Goble does not explicitly disclose a biomarker comprising DNA or RNA which may be detected by collecting and sequencing the biomarker. However, this claim is drawn to a device and not necessarily a method of using the device. Depending on the patient’s disease status, their blood will contain various biomarkers including DNA or RNA.
Claims 2, 4, 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Goble and Razavi in view of Leeflang; Stephen A. et al. (US 20110276023 A1).
Regarding claims 2, 4, 8 and 14, Goble and Razavi do not deliver an immunotherapy compound or cancer therapy and also lack an assay device or sample filter. Leeflang discloses a dual-port surgical drain (¶ [0002], [0004], [0012], [0022], FIGS. 1 and 2A … a system 10);
comprising: a treatment reservoir (¶ [0032], a waste container 60, a storage container 70);
a surgical drain tube that passes through a patient’s skin (¶ [0022], Generally, the system 10 may include a catheter 20 that includes a proximal end 22, a distal end 24, and one or more lumens 26 extending therebetween, e.g., an aspiration or infusion lumen 26 communicating with a port 27); and
a treatment tube that passes through the patient’s skin (¶ [0009], [0027], In addition, the catheter 24 may include an infusion lumen; ¶ [0032], FIG. 1, the external components include … an infusion device 80; ¶ [0046], For example, lymphatic fluid may be removed from the thoracic duct 94 through the lumen 26 of the catheter 20 and/or one or more agents may be introduced into the thoracic duct 94, e.g., through the lumen 26 or another lumen of the catheter 20);
wherein the treatment tube delivers an immunotherapy compound (¶ [0009], Other applications may include rapid immunization by direct introduction of antigens and/or antigenic material into the lymphatic system);
wherein the treatment reservoir contains, and wherein the treatment tube delivers a cancer therapy (¶ [0009], infusion of antibiotic, antiviral, antiparisitic, and/or chemotherapeutic agents directly into the lymphatic system);
further comprising an assay device for detecting cellular material from the surgical drain tube (¶ [0033] Returning to FIG. 1, the detector 40 may be coupled to the proximal end 22 of the catheter 20 … The detector 40 may include one or more sensors (not shown), e.g., for distinguishing between lymphatic fluid and blood; ¶ [0035] For example, if the controller 45 determines that the fluid includes blood, the controller 45 may direct the fluid to the waste container 60, e.g., through the separator 50 or directly);
wherein the first port comprises a sample filter for capturing solid particles (¶ [0038], Alternatively, it may be desirable to separate certain constituents of the removed fluid, e.g., lymphatic fluid, particular cells, proteins, and the like. For example, the separator 50 may include one or more of a mechanical filtration system, an osmotic gradient system, a concentration gradient system, a centrifuge, and the like to separate the desired components from the rest of the fluid).
Regarding the treatment reservoir that contains an immunotherapy compound or cancer therapy, Leeflang recirculates fluid through the patient’s lymphatic system and also through storage container 70 (¶ [0012], Optionally, the stored lymphatic fluid or the separated components of the lymphatic fluid may be infused back into the patient's body, if desired). When antigenic material or chemotherapeutic agents are infused into the patient’s circulation, they will also circulate through storage container 70.
Leeflang delivers a wider range of therapeutic agents and also monitors a patient to detect infection or malignancy (¶ [0009], Further clinical applications may include diagnosis and/or monitoring of malignancy or metastatic spread of malignant cells, or treatment of infection or malignancy). One would be motivated to modify Goble and Razavi with Leeflang’s therapeutic agents or monitoring equipment to detect if a patient’s surgical wound has become infected and to respond quickly before the infection worsens. Therefore, it would have been obvious to modify Goble and Razavi with Leeflang’s therapeutic agents or monitoring equipment in order to prevent or resolve an infection or malignancy.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Goble and Razavi in view of Orth; Donald S. (US 20210361846 A1).
Regarding claim 15, Goble and Razavi do not explicitly disclose a heat source. Orth discloses an external biochemical reactor and detoxification method (¶ [0002], [0007], [0030], FIG. 1 illustrates a system 100; ¶ [0032], Other bodily fluids such as cerebrospinal fluid, lymph fluid … can also be processed);
comprising a first port for collection of fluid and a second port for delivering the fluid (¶ [0030], FIG. 1 … The system 100 includes an extracorporeal device 110 having an inlet 112 and outlet 114; ¶ [0041], FIG. 3 … The system 300 includes an extracorporeal device 310 having a luer lock inlet 312 and luer lock outlet 314; ¶ [0042] FIG. 4 … The system 400 includes an extracorporeal device 410 having a luer lock inlet 412 and luer lock outlet 414);
wherein the first port further comprises a heat source (¶ [0041], In this embodiment, a heater element 332 can be connected to the control and monitor device to maintain blood temperature at about 37 degrees Celsius for human patients, or normal blood temperature for non-human patients; ¶ [0042], In this embodiment, a heater element 432 can be connected to the control and monitor device to maintain blood temperature at a desired set point).
Orth maintains a temperature of a fluid in its physiological range. A skilled artisan would have been able to modify Goble and Razavi with Orth’s heat source by installing a heater along the path of Goble’s treatment system according to Orth’s example. One would be motivated to modify Goble and Razavi with Orth’s heat source so that the infused medication remains close to body temperature. Therefore, it would have been obvious to modify Goble and Razavi with Orth’s heat source in order to infuse a fluid close to body temperature.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Goble and Razavi in view of Zamarripa; Nathan et al. (US 20140114227 A1).
Regarding claim 21, Goble and Razavi lack a branched drain tube. Zamarripa discloses a proximal portion of a drain tube that branches into a series of sub-tubes (¶ [0029] FIG. 4 …medical device 210 that may be similar in form and function to other devices disclosed herein … one or both of catheter portions 214a/214b may be further branched. For example, catheter portion 214a may include catheter branches 214a'/214a''. The number and/or configuration of the branches can vary).
Zamarripa anchors a catheter in the patient’s body and also provides redundant openings that minimize the risk of clogging. One would be motivated to modify Goble and Razavi with Zamarripa’s branched drain tube to anchor the catheter since Goble calls for multiple variants of a catheter (Figs. 2-7 show variations how the lumens connect or overlap). Therefore, it would have been obvious to modify Goble and Razavi with Zamarripa’s branched drain tube in order to anchor the catheter with a known structure.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Goble and Razavi in view of Burnett; Daniel R. et al. (US 20070106247 A1).
Regarding claims 22 and 23, Goble and Razavi lack a physiological sensor positioned at a proximal end of the drain tube. Burnett discloses apparatus and methods for providing therapeutic hypothermia treatment to a patient (¶ [0002], [0005], [0047], FIGS. 1-5, an embodiment of a system 10);
comprising a treatment tube and drain tube (¶ [0066], the catheter 50 can split up from one another at a point 59 into separate portions 50i and 50r containing the infusion and removal lumens to provide for easy connection to reservoir 70 and waste container 80 as is shown in FIG. 2b);
further comprising a physiological sensor configured to monitor at least one physiological parameter of a subject; wherein the physiological sensor is positioned at a proximal end of the drain tube (¶ [0048], A temperature or other sensor 120 is connected to the patient at an IV or other site to measure the patient's temperature; ¶ [[0068] Catheter 50 will typically include one or more sensors 120 which be selected to measure, flow rates, pressure, temperature or other physical property … Multiple temperature sensors may be placed at various locations on the catheter … Temperature sensors 120 can also be placed within lumens 55 and 56 to monitor the temperature of infused and removed fluid).
Burnett monitors a patient’s temperature or pressure and also collects information about a catheter’s location within the patient (¶ [0071] Catheter 50 can also include one or more pressure sensors 120 … pressure sensors 120 can be positioned in lumen 55 to detect entry of infusion catheter into the peritoneal or other cavity; ¶ [0061] Sensors 120 can be configured to measure a variety of physical properties related to the use of system 10. Accordingly, they can comprise a variety of biomedical sensors known in the art, including temperature sensors, pressure sensors, force sensors, flow sensors, pH sensors, oxygen and other gas sensors (e.g., CO.sub.2), acoustic sensors, piezoelectric sensors, and the like; ¶ [0091], A temperature sensor 120 can be positioned near the tip to detect movement of the sheath (by detecting a change in temperature when this occurs), as well as measure temperature in the peritoneal or other cavity). One would be motivated to modify Goble and Razavi with Burnett’s proximal physiological sensors to confirm or monitor the catheter’s position. Therefore, it would have been obvious to modify Goble and Razavi with Burnett’s proximal physiological sensor in order to detect when the catheter has moved.
Response to Arguments
Applicant’s arguments filed 29 January 2026 regarding the rejection of claims 1-10, 14-19 and 21-23 as amended, under 35 USC § 103 over Goble, Razavi, Leeflang, Orth and Zamarripa, have been fully considered but are not persuasive. Therefore, the rejections are maintained.
New claim 24 has been considered and is rejected under 35 USC § 103 over Goble and Razavi (see above).
Applicant submits that yet, as the Office Action notes, Goble does not disclose a first and a second port configured to form sealed passages (remarks p. 5). Examiner notes that claim 1 is rejected over the combination of Goble and Razavi.
Applicant asserts that while Razavi reports that the conduits may be used for therapeutic infusions, there is no indication that the reported systems are useful as surgical drains (remarks p. 6). Examiner notes that Goble, not necessarily Razavi, is cited as teaching a surgical drain (¶ [0020] Aspiration catheter 15). Razavi is cited as teaching a dual-port surgical drain suitable for interfacing between an external environment and the patient’s body (¶ [0062] FIGS. 1A-1D … The luminal access system 100 can include a port 102; ¶ [0072] FIGS. 2A-2C … luminal access system 200; ¶ [0084] FIG. 2A … The luminal access system 200 can include a plurality of conduits 260, each with valves 280 near each conduit's proximal end and distal end).
Applicant contends that yet, Goble asserts that the reported device is effective to prevent infection. Accordingly, there would be no motivation for the skilled artisan to look elsewhere based on the Office Action's rationale (remarks p. 6). Examiner replies that Goble does not accommodate the catheter’s movements at the incision, which will apply lateral and axial forces at the incision. Razavi counteracts these effects with a concave-shaped port (Figs. 2A-2C). For this reason, a skilled artisan would have looked to Razavi’s dual-port system in order to prevent the patient’s movements from disrupting the catheters.
Applicant submits that Razavi's first solution for infection prevention is the use of a cap … Yet, the cap would cause the combined device not to function, and a cap is not recited in the pending claims (remarks p. 6-7).
Examiner acknowledges that none of the claims recite a cap. Also, Razavi’s cap is intended to seal the port when no tube or catheter extends through the port (¶ [0085] FIG. 2B … The cap 272 is removed … The cap can be screwed on and off with a technique to maintain sterility). Since the claims do not recite a cap, and also since the cap covers the port when tubes are absent, Razavi’s cap is not relevant to this argument.
Applicant asserts that Razavi's second solution for infection prevention is the non-use or avoidance of indwelling catheters. Yet, Goble depends on the use of catheters. These opposing teachings would have signaled to the skilled artisan that the references could not be combined with a reasonable expectation of success (remarks p. 7). Examiner finds that Razavi mentions an “indwelling” catheter only at ¶ [0057], as a counterexample for long term dialysis access. In comparison, Goble installs a catheter only while a surgical wound heals after surgery (¶ [0018], System 35 is applied to a knee 25 of a patient to treat a surgical wound that would result from, for example, a total knee arthroplasty surgery).
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application is assigned is 571-273-8300.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781