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 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 03/19/2026 has been entered.
An amendment was filed on 03/19/2026. Claims 1 and 20 have been amended, and claims 2-4, 5-8, 10-12, 14-16, and 29 have been canceled. Currently, claims 1, 9, 13, 17-25, 27-28, and 30-31 are pending and are being examined on the merits.
Response to Amendment
An amendment was filed on 07/26/2024. Claims 1, 3, 9, and 24 have been amended, and claims 2, 5-8, 10-12, 14-16, 26, and 29 have been canceled. Currently, claims 1, 3-4, 9, 13, 17-25, 27-28, and 30-31 are pending and are being examined on the merits.
Response to Arguments
Applicant's arguments filed 93/19/2026 have been fully considered but they are not persuasive.
In response to the applicant’s arguments , notably wherein Tanaka fails to teach fluid removal using a pneumostomy catheter, and fails to teach wherein the device can be used to aspirate air and/or fluid, examiner notes that the teachings of Tanaka are not utilized for fluid removal. Rather, Tanaka teaches modifying the port used to inflate the ballon to become a valve port in order to prevent backflow of fluid leaving the balloon to assist in keeping the balloon inflated.
In response to the applicant’s argument wherein Campbell is designed to minimize escape of gas introduced into the patient’s pneumoperitoneum, which is the opposite of the intent of the instant invention, and does not teach adding gas to a stabilizing component (i.e., the balloon), the examiner respectfully disagrees.
While the intent of Campbell is to minimize escape of gas introduced into the patient’s pneumoperitoneum, the pertinence of this prior art in light of Breznock and Tanaka is the utilization of valves to prevent fluid from exiting, which Tanaka desires with respect to its check valve for the balloon. Although Campbell desires for fluid being added to the patient to not escape, one of ordinary skill in the art would appreciate that such a structure would also be pertinent for not letting fluid being added to a balloon escape.
Moreover, even with the check valve taught in Breznock, the teachings of Campbell would be pertinent as a check valve is intended to prevent fluid from exiting when not desired.
It is further noted that the limitations of claims 3-4 that Campbell were utilized to teach (i.e., the external valve port being operable to permit a check valve to be removably inserted into the frame) is not present in amended claim 1.
In response to the applicant’s arguments that the remaining claims are allowable based on dependency of claim 1, the allowability of claim 1 has been addressed above.
In response to the applicant’s arguments with respect to the double patenting rejection in light of co-pending U.S. Application No. 18/074,191, wherein there is no overlapping ownership between the two applications, the examiner respectfully disagrees.
The applicant of the instant application is Quick Tube Medical, LLC, with inventors including Byron Smith and Ryan Luttrell, which are the same applicant and inventors of the ‘191 application.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 18 recites “at the proximal end of the frame at the proximal end of the frame”, which appears to be an unintentional repeat, and should be corrected.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 17-18 and 20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 17-18 and 20 comprise language that is present in currently amended claim 1. It appears that these limitations were intended to be moved into claim 1 and were not canceled. With respect to claim 20, a “1-way valve” is already cited in claim 1 as a “check valve”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 1, 13, 17-23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Breznock (US 20030018309) in view of Tanaka (US 20090209856), and further in view of Kiev ‘485 (US 20190307485).
Regarding claim 1, Breznock discloses a rapid deployment chest port, comprising:
a frame (22) comprising a lumen and a plunger port (24) (fig. 1, frame includes multi-lumen tubing 22 with drainage adapter 24. In fig. 3A-3B, trocar 40 with plunger 42 is inserted into the drainage lumen 32 via the drainage adapter 24, paragraph 0037);
a removable plunger (44) comprising a blade (46) at the distal end (fig. 3, trocar 44 with needle 46 at the end, also see paragraph 0037, “The trocar 40 is removed”. NOTE: instant specification notes that a blade can be a needle, see paragraph 0056, “Non-limiting examples of blades include a needle”), wherein the removable plunger is within the lumen of the frame (fig. 4, trocar 44 within the lumen of the tubing 22); and
a stabilizing component (16 and 18) configured to stabilize the frame inside and outside a chest cavity of a patient (fig. 1, extracorporeal fixation device 16 and intracorporeal fixation device 18, paragraph 0029 ), the stabilizing component comprising:
an inflatable balloon (18) attached to an outer diameter of the frame (paragraph 0029, “In this preferred embodiment, the intracorporeal fixation device 18 is a balloon) and configured to be expanded within the chest cavity of the patient (paragraph 0016, “The balloon is passed inside the chest cavity and is inflated with sterile liquids or air to prevent withdrawal); and
an insertion stabilization platform (18) attached to and slidable along the outer diameter of the frame proximal to the balloon (paragraph 0033, “The extracorporeal fixation device 16 is slidably located on the outside of the multi-lumen tubing 22, between the manifold 12 and the intracorporeal fixation balloon 18.”).
an external valve port attached to the outer diameter of the frame (fig. 1, balloon 18 with inflation adapter 28) and fluidly connected to the inflatable balloon (fig. 1, inflation adapter 28 to inflate balloon), the port operable to receive a syringe and expand the balloon (paragraph 0029)
Breznock does not teach an external check valve port attached to the outer diameter of the frame and fluidly connected to the inflatable balloon, and a handle with a connector operable to removably attach the handle to the plunger port at the proximal end of the frame, wherein the handle further comprises a syringe port operable to receive an aspiration syringe, the aspiration syringe capable of aspirating a volume of air or fluid to confirm placement.
However, Tanaka teaches a device to treat pulmonary disease (abstract) comprising an external valve port (324) attached to the outer diameter of the frame (fig. 3D, check valve 324 attached to outer diameter of tube or frame 352 via tube 320 connecting to shoulder 374.), wherein the external valve port (324) is fluidly connected to a balloon (358) (fig. 3D, inflation tube 320 connected to check valve 324 is designed to inflate balloon 356, paragraph 0104, “Tube 302 is also connected to an inflation tube 320. At the proximal end of the inflation tube 320 is a pilot balloon 322, a check valve 324 a coupling 326 and cap 328. Coupling 326 is designed to receive a syringe so that air, water or saline may be injected through inflation tube 320 into pneumoplasty balloon 306.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock such that it further comprises an external valve port attached to the outer diameter of the frame, wherein the external valve port is fluidly connected to the balloon, as taught by Tanaka, for the purpose of providing a suitable structure that allows for fluid or air to enter the balloon to inflate said balloon without air or fluid leaving the balloon after inflation.
Breznock fails to teach a handle with a connector operable to removably attach the handle to the plunger port at the proximal end of the frame, wherein the handle further comprises a syringe port operable to receive an aspiration syringe, the aspiration syringe capable of aspirating a volume of air or fluid to confirm placement.
However, Kiev ‘485 teaches a cannula assembly (104) comprising a handle (102) with a connector (222) operable to removably attach the handle (102) to the plunger port at a proximal port at a proximal end of the frame (104) (fig. 2, handle 102 attaches to cannula assembly 104 or cannula shaft 264 using the cannula slot 222 and the protrusion 266, paragraph 0058), wherein the handle comprises a syringe port operable to receive an aspiration syringe (fig. 2, hub 202), the aspiration syringe capable of aspirating a volume of air or fluid to confirm placement (paragraph 0116, “To confirm the safety needle 110 is in target 504, the user with attach a fluid drainage device to hub 202”. The hub 202 would be capable of receiving a syringe depending on the connection type. The syringe port of the handle 102 is the area in which port 202 that accepts said syringe is inserted into handle 102).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock a handle with a connector operable to removably attach the handle to the plunger port at the proximal end of the frame, wherein the handle further comprises a syringe port operable to receive an aspiration syringe, the aspiration syringe capable of aspirating a volume of air or fluid to confirm placement, as taught and suggested by Kiev ‘485, for the purpose of providing a suitable structure that grants the user a grip to better handle the assembly (see Kiev ‘485, paragraph 0061), and for providing a suitable structure that allows for a sample of fluid to be drawn into the fluid drainage device to determine if the frame is in the correct location (see Kiev ‘485, paragraph 0116)
Regarding claim 13, Breznock discloses wherein the insertion stabilization platform further comprises a fixation flexure (paragraph 0045 describes a clip 16 as a spring clip, the spring being the fixation flexure as it flexes the coils) operable to allow sliding of the insertion stabilization platform along the outer diameter of the frame (paragraph 0045, “when the spring is compressed, the clip 16 is slid to the desired location on the catheter 10”) and then secure the insertion stabilization platform to the frame (paragraph 0045,“When the pressure on the spring is released, the clip 16 is locked into place on the catheter 10”).
Regarding claim 17, Breznock fails to teach the device further comprising a handle with a connector operable to removably attached the handle to the plunger port at a proximal end of the frame.
However, Kiev ‘485 teaches a cannula assembly (104) comprising a handle (102) with a connector (222) operable to removably attach the handle (102) to the plunger port at a proximal port at a proximal end of the frame (104) (fig. 2, handle 102 attaches to cannula assembly 104 or cannula shaft 264 using the cannula slot 222 and the protrusion 266, paragraph 0058).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock such that it further comprises a handle with a connector operable to removably attach the handle to the plunger port at a proximal end of the frame, as taught and suggested by Kiev ‘485, for the purpose of providing a suitable structure that grants the user a grip to better handle the assembly (see Kiev ‘485, paragraph 0061).
Regarding claim 18, Breznock fails to teach wherein the handle further comprises a syringe port operable to receive an aspiration syringe.
However, Kiev ‘485 teaches wherein the handle (102) further comprises a syringe port operable to receive an aspiration syringe (paragraph 0116, “To confirm the safety needle 110 is in target 504, the user with attach a fluid drainage device to hub 202”. The hub 202 would be capable of receiving a syringe depending on the connection type. The syringe port of the handle 102 is the area in which port 202 that accepts said syringe is inserted into handle 102).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock such that the handle further comprises a syringe port operable to receive an aspiration syringe, as taught and suggested by Kiev ‘485, for the purpose of providing a suitable structure that allows for a sample of fluid to be drawn into the fluid drainage device to determine if the frame is in the correct location (see Kiev ‘485, paragraph 0116).
Regarding claim 19, Breznock discloses wherein the plunger port is a 1- way valve (paragraph 0055, “the valve or seal 14 is a duckbill or one-way valve”, the valve 14 being a part of the port 24).
Regarding claim 20, Breznock fails to teach wherein the external valve port is a 1-way valve operable to receive a syringe to expand the balloon.
However, Tanaka teaches wherein the external valve port is a 1-way valve (paragraph 0173 describes the port being a check valve 324) operable to receive a syringe to expand the balloon (paragraph 0104, “coupling 326 is designed to receive a syringe so that air, water or saline may be injected through the inflation tube 320 into pneumoplasty balloon 306”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock such that the external valve port is a 1-way valve operable to receive a syringe to expand the balloon, as taught by Tanaka, for the purpose of providing a suitable structure that allows for fluid or air to enter the balloon to inflate said balloon without air or fluid leaving the balloon after inflation.
Regarding claim 21, Breznock is silent to wherein a ratio of a diameter of the balloon to the diameter of the frame is 2.5 to 6.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ratio of a diameter of the balloon to the diameter of the frame to be 2.5 to 6 for the purpose of providing a suitable size for the balloon to properly anchor the device within the body (paragraph 0029, “intracorporeal fixation device”), and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this instance, the size of the balloon for a catheter is considered a result effective variable, as it determines how well the balloon is anchored within the body. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Breznock such that the ratio of a diameter of the balloon to the diameter of the frame is 2.5 to 6, since the balloon can be inflated at various levels depending on how much fluid is put into the balloon.
Regarding claim 22, Breznock discloses wherein the blade (46) has a cone shape (fig. 3A shows the needle 46 having a cone shape, paragraph 0037).
Regarding claim 23, Breznock discloses wherein the blade (46) is a needle (fig. 3A, needle 46, paragraph 0037).
Regarding claim 25, Breznock, as modified by Tanaka and View’ 485, discloses a method of removing air or fluid or both contained within a pleural space of a mammalian patient (abstract, “The device serves as a conduit for drainage of excessive fluid or air buildup in the chest”), the method comprising:
inserting the blade (46) of the removable plunger (44) and a distal portion of the frame (22) of the rapid deployment chest port of claim 1 (see analysis of claim 1 above) into a chest cavity of a patient (paragraph 0018),
expanding the balloon (18) on the inside of the chest cavity of the patient (paragraph 0040, “once the chest drainage tube 10 is placed in the patient’s chest, the intracorporeal fixation balloon 18 is inflated”), and
removing the plunger from the plunger port (paragraph 0004, “The trocar is removed and the chest tube is clamped to prevent pneumothorax”).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Breznock in view of Tanaka and Kiev ‘485, and further in view of Donaldson (US 9616203).
Regarding claim 9, Breznock fails to teach wherein the blade is fluidly connected to the frame.
However, Donaldson teaches a device for treating pneumothorax (abstract) comprising a frame (20) and a probe (50) within the frame (fig. 4, probe 50 within hollow needle 20), wherein the probe (50) is fluidly connected with the frame (fig. 4, ports or openings 54 of the probe 50). While the probe (50) is not a blade, it is similarly used to puncturing the chest wall (abstract)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock such that the blade is fluidly connected to the frame, as taught by Donaldson, for the purpose of providing a suitable structure that allows the device to puncture the chest wall and immediately open a pathway to let fluid flow (see Donaldson, abstract).
Claims 24 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Breznock in view of Tanaka and Kiev ‘485, and further in view of Real (US 20160067391), and Campbell (US 20050004512).
Regarding claim 24, Breznock discloses wherein the plunger port is configured to connect to a suction source (paragraph 0034), but fails to teach the device further comprising an external valve assembly operable to connect to the plunger port and a suction source, the external valve assembly being further operable to permit a check valve to be removably inserted into the frame.
However, Real teaches a transcutaneous device for removal of fluid from a body (abstract) that comprises an external check valve assembly (fig. 30, assembly with check valve 163 starting at Luer 160) operable to connect to a suction source (paragraph 0185, “Using the syringe, fluid may be drawn from the patient and pumped into the drainage bag… A syringe may be attached at a flushing port 162 or at a pumping port 164”).
As the plunger port of Breznock is where the suction source is applied, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock such that it further comprises an external check valve assembly operable to connect to the plunger port and a suction source, as taught by Real, for the purpose of providing a suitable structure that permits flow of fluid through the valve only in the proximal direction (see Real, paragraph 0030), thus further preventing back flow of drained fluid.
Breznock, as modified by Real, discloses a check valve in the frame (see Breznock, valve 14 may be a duckbill valve as a well-known check valve, paragraph 0014), but fails to teach wherein the external valve assembly is further operable to permit a check valve to be removably inserted into the frame.
However, Campbell teaches a pneumoseal trocar arrangement (abstract) that suggests that allowing a valve to be inside the trocar or frame while having it be removable is known in the art (paragraph 0015, “The valve may comprise an inner portion of a proximal cap which is fixed or removably attachable to the proximal end of the cannula.)
Campbell is considered analogous art because it pertains to a trocar meant to be inserted into the patient’s body. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock in view of Real such that the external valve port is operable to permit a check valve to be removably inserted into the frame, as taught by Campbell, for the purpose of providing a suitable means for the valve to provide a seal and minimize the escape of gas (see Campbell, abstract) and so that the valve can be replaced if damaged, and since it has been held that if were considered desirable to make components separable, it would have been obvious to do so for that desired purpose. See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961), MPEP 2144.04(V)(B).
Regarding claim 31, Breznock fails to teach wherein the external check valve assembly comprises: a connector configured to connect to the plunger port, a valve outlet tubing operably associated with the connector, a check valve operably associated with the valve outlet tubing, and a valve inlet tubing operably connected to the check valve and proximal to the check valve.
However, Real teaches wherein the external check valve assembly comprises: a connector (160) configured to connect to where suction is applied (paragraph 0185, “Using the syringe, fluid may be drawn from the patient and pumped into the drainage bag”), a valve outlet tubing operably associated with the connector (see annotated fig. 30 below), a check valve (163) operably associated with the valve outlet tubing (fig. 30, one-way valve 163, paragraph 0185, “One-way valves 163 are also provided), and a valve inlet tubing operable connected to the check valve (163) and proximal to the check valve (see annotated fig. 30 below).
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As the plunger port of Breznock is where the suction source is applied, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock such that the external check valve assembly comprises a connector configured to connect to the plunger port, a valve tubing operably associated with the connector, a check valve operably associated with the valve outlet tubing, and a valve inlet tubing operable connected to the check valve and proximal to the check valve, as taught by Real, for the purpose of providing a suitable structure that permits flow of fluid through the valve only in the proximal direction (see Real, paragraph 0030).
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Breznock in view of Tanaka and Kiev ‘485, and further in view of Real.
Regarding claim 27, Breznock discloses the method comprising connecting a suction source to the plunger port (paragraph 0034, “When the catheter 10 is in use, the manifold 12 connects to a drainage system through the drainage adapter 24… The drainage adapter 24 is capable of being connected to the gravity-fed, pump-driven or vacuum-fed drainage system”) and removing air or fluid or both from the pleural space (paragraph 0037, “Medical personnel push the plunger 42 to force the needle 46 into the thoracic cavity through the muscle, fascia and fat layers of the patient, through the rib space and into the pleural cavity. The trocar 40 is removed and the chest drainage tube 10 is in place.”), but fails to teach the method further comprising: connecting a check valve and a suction source to the plunger port, and removing air or fluid or both from the pleural space.
However, Real teaches a transcutaneous device for removal of fluid from a body (abstract) that connects a check valve assembly (fig. 30, assembly with check valve 163 starting at screw-threaded Luer 160, paragraph 0185) to a suction source (paragraph 0185, “Using the syringe, fluid may be drawn from the patient and pumped into the drainage bag… A syringe may be attached at a flushing port 162 or at a pumping port 164”), and removing air or fluid or both (paragraph 0185, “Using the syringe, fluid may be drawn from the patient and pumped into the drainage bag… A syringe may be attached at a flushing port 162 or at a pumping port 164”).
As the plunger port is the area where suction is applied, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Breznock to include connecting a check valve and a suction source to the plunger port, as taught and suggested by Real, for the purpose of providing a suitable structure that permits flow of fluid through the valve only in the proximal direction (see Real, paragraph 0030), thus further preventing backflow of drained fluid.
Regarding claim 28, Breznock discloses the method further comprising deflating the balloon and removing the rapid deployment chest port from the patient (paragraph 0040, "The balloon inflation fluid is selectively drained from the intracorporeal fixation balloon 18 by opening the stopcock to deflate the balloon 18 and allow the cannula 10 to be removed from the patient’s chest”).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Breznock in view of Tanaka and Kiev ‘485, and further in view of Kiev ‘435 (US 20160235435).
Regarding claim 30, Breznock discloses wherein the rapid deployment chest port is inserted into the pleural space of the patient (paragraph 0018), but fails to teach the method comprising aspirating a volume of air or fluid or both using a syringe attached to a handle of the rapid deployment chest port to confirm placement of the rapid deployment chest port within the pleural space of the patient.
However, Kiev ‘485 teaches a method for access into interior body regions (abstract) that aspirates a volume of air or fluid using a fluid drainage device (104) attached to a handle (102) (fig. 2, handle 102 connected to cannula assembly 104) to confirm placement of the needle within the relevant space (fig. 1, handle assembly 102, fig. 11, needle 110 and hub 202 attached to handle configured to have fluid drainage device attached to it to confirm that the needle 110 is in the correct space, paragraph 0116)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Breznock such that it comprises aspirating a volume of air or fluid using a suction device attached to a handle of the rapid deployment chest port to confirm placement of the rapid deployment chest port within the pleural space of the patient, as taught and suggested by Kiev ‘485, for the purpose of providing a suitable method that confirms that the port is in the correct space (see Kiev, paragraph 0116).
Breznock, as modified by Kiev ‘485, is silent to teach wherein the suction device is a syringe.
However, Kiev ‘435 teaches a similar method of confirming if the needle is in the correct location that uses a syringe as a fluid drainage device (paragraph 0043, “Fluid drainage devices that may be used include syringes”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Breznock in view of Kiev ‘485 such that the suction device is a syringe, as taught by Kiev ‘435, for the purpose of providing a suitable structure that can suction fluid to confirm if the assembly is in the correct location (see Kiev ‘435, paragraph 0043).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 13, 21-23, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 8-12 of copending Application No. 18/074191 published as US 20230102684 in view of Breznock, and further in view of Tanaka and Kiev ‘485.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the copending application contains all of the limitations of instant claim 1, or in other words, copending claim 1 is a more specific version of instant claim 1, save for an external check valve port attached to the outer diameter of the frame and fluidly connected to the inflatable balloon, the external valve port operable to receive a syringe and expand the balloon, and a handle with a connector operable to removably attach the handle to the plunger port at the proximal end of the frame, wherein the handle further comprises a syringe port operable to receive an aspiration syringe, the aspiration syringe capable of aspirating a volume of air or fluid to confirm placement.
Instant Application
Co-pending Application 18/074,191
A rapid deployment chest port, comprising:
a frame comprising a lumen and a plunger port; a removable plunger comprising a blade at the distal end, wherein the removable plunger is within the lumen of the frame; and a stabilizing component configured to stabilize the frame inside and outside a chest cavity of a patient, the stabilizing component comprising: an inflatable balloon attached to an outer diameter of the frame and configured to be expanded within the chest cavity of the patient; and an insertion stabilization platform attached to and slidable along the outer diameter of the frame proximal to the balloons, an external check valve port attached to the outer diameter of the frame and fluidly connected to the inflatable balloon, the external valve port operable to receive a syringe and expand the balloon; and a handle with a connector operable to removably attach the handle to the plunger port at the proximal end of the frame at the proximal end of the frame, wherein the handle further comprises a syringe port operable to receive an aspiration syringe, the aspiration syringe capable of aspirating a volume of air or fluid to confirm placement.
A rapid deployment chest port, comprising: a frame comprising a lumen; a plunger at least partially within a lumen of the frame, the plunger comprising a stylet shaft traversing the interior of the lumen of the frame, a needle operably connected to the distal end of the frame, the distal tip of the needle comprising a concave curvature, and a plunger port at the proximal end of the plunger; and a balloon attached to the outer diameter of the frame, the balloon configured to expand in the interior of the chest cavity of the patient; an external valve port attached to the outer diameter of the frame and fluidly connected to the balloon; and an insertion stabilization platform slidable along the outer diameter of the frame and proximal to the balloon.
Breznock does not teach an external check valve port attached to the outer diameter of the frame and fluidly connected to the inflatable balloon, and a handle with a connector operable to removably attach the handle to the plunger port at the proximal end of the frame, wherein the handle further comprises a syringe port operable to receive an aspiration syringe, the aspiration syringe capable of aspirating a volume of air or fluid to confirm placement.
However, Tanaka teaches a device to treat pulmonary disease (abstract) comprising an external valve port (324) attached to the outer diameter of the frame (fig. 3D, check valve 324 attached to outer diameter of tube or frame 352 via tube 320 connecting to shoulder 374.), wherein the external valve port (324) is fluidly connected to a balloon (358) (fig. 3D, inflation tube 320 connected to check valve 324 is designed to inflate balloon 356, paragraph 0104, “Tube 302 is also connected to an inflation tube 320. At the proximal end of the inflation tube 320 is a pilot balloon 322, a check valve 324 a coupling 326 and cap 328. Coupling 326 is designed to receive a syringe so that air, water or saline may be injected through inflation tube 320 into pneumoplasty balloon 306.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock such that it further comprises an external valve port attached to the outer diameter of the frame, wherein the external valve port is fluidly connected to the balloon, as taught by Tanaka, for the purpose of providing a suitable structure that allows for fluid or air to enter the balloon to inflate said balloon without air or fluid leaving the balloon after inflation.
Breznock fails to teach a handle with a connector operable to removably attach the handle to the plunger port at the proximal end of the frame, wherein the handle further comprises a syringe port operable to receive an aspiration syringe, the aspiration syringe capable of aspirating a volume of air or fluid to confirm placement.
However, Kiev ‘485 teaches a cannula assembly (104) comprising a handle (102) with a connector (222) operable to removably attach the handle (102) to the plunger port at a proximal port at a proximal end of the frame (104) (fig. 2, handle 102 attaches to cannula assembly 104 or cannula shaft 264 using the cannula slot 222 and the protrusion 266, paragraph 0058), wherein the handle comprises a syringe port operable to receive an aspiration syringe (fig. 2, hub 202), the aspiration syringe capable of aspirating a volume of air or fluid to confirm placement (paragraph 0116, “To confirm the safety needle 110 is in target 504, the user with attach a fluid drainage device to hub 202”. The hub 202 would be capable of receiving a syringe depending on the connection type. The syringe port of the handle 102 is the area in which port 202 that accepts said syringe is inserted into handle 102).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock to include a handle with a connector operable to removably attach the handle to the plunger port at the proximal end of the frame, wherein the handle further comprises a syringe port operable to receive an aspiration syringe, the aspiration syringe capable of aspirating a volume of air or fluid to confirm placement, as taught and suggested by Kiev ‘485, for the purpose of providing a suitable structure that grants the user a grip to better handle the assembly (see Kiev ‘485, paragraph 0061), and for providing a suitable structure that allows for a sample of fluid to be drawn into the fluid drainage device to determine if the frame is in the correct location (see Kiev ‘485, paragraph 0116)
Regarding claim 13, copending claim 5 discloses substantially the limitations of claim 13, but is silent to wherein the movement is sliding the insertion stabilization platform along the outer diameter of the frame.
However, Breznock teaches wherein the insertion stabilization platform (16) is slide along the outer diameter of the frame (fig. 1, extracorporeal fixation device 16 slidably located on the tubing 22, paragraph 0033).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in copending claim 5 such that the movement is sliding the insertion stabilization platform along the outer diameter of the frame, as taught by Breznock, for the purpose of providing a suitable means of adjusting the insertion stabilization platform in order to prevent the tube from inadvertently being pushed farther into the patient’s chest (see Breznock, paragraph 0042).
Regarding claim 21, Breznock is silent to wherein a ratio of a diameter of the balloon to the diameter of the frame is 2.5 to 6.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ratio of a diameter of the balloon to the diameter of the frame to be 2.5 to 6 for the purpose of providing a suitable size for the balloon to properly anchor the device within the body (paragraph 0029, “intracorporeal fixation device”), and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this instance, the size of the balloon for a catheter is considered a result effective variable, as it determines how well the balloon is anchored within the body. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Breznock such that the ratio of a diameter of the balloon to the diameter of the frame is 2.5 to 6, since the balloon can be inflated at various levels depending on how much fluid is put into the balloon.
Regarding claim 22, Breznock discloses wherein the blade (46) has a cone shape (fig. 3A shows the needle 46 having a cone shape, paragraph 0037).
Regarding claim 23, Breznock discloses wherein the blade (46) is a needle (fig. 3A, needle 46, paragraph 0037).
Regarding claim 25, claim 20 of the copending application substantially describes the method disclosed in claim 20 except that the blade of the removable plunger is specifically inserted at a distal portion of the frame.
However, Breznock teaches wherein the plunger (42) is inserted at a distal end of the frame (22)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in copending claim 20 such that the blade of the removable plunger is inserted at a distal portion of the frame, as taught by Breznock, for the purpose of providing a suitable method of inserting the plunger to go thought the thoracic cavity through muscle and into the pleural cavity (see Breznock, paragraph 0037).
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Regarding claim 20, Breznock fails to teach wherein the external valve port is a 1-way valve operable to receive a syringe to expand the balloon.
However, Tanaka teaches wherein the external valve port is a 1-way valve (paragraph 0173 describes the port being a check valve 324) operable to receive a syringe to expand the balloon (paragraph 0104, “coupling 326 is designed to receive a syringe so that air, water or saline may be injected through the inflation tube 320 into pneumoplasty balloon 306”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock such that the external valve port is a 1-way valve operable to receive a syringe to expand the balloon, as taught by Tanaka, for the purpose of providing a suitable structure that allows for fluid or air to enter the balloon to inflate said balloon without air or fluid leaving the balloon after inflation.
Regarding claim 17, Breznock fails to teach the device further comprising a handle with a connector operable to removably attached the handle to the plunger port at a proximal end of the frame.
However, Kiev ‘485 teaches a cannula assembly (104) comprising a handle (102) with a connector (222) operable to removably attach the handle (102) to the plunger port at a proximal port at a proximal end of the frame (104) (fig. 2, handle 102 attaches to cannula assembly 104 or cannula shaft 264 using the cannula slot 222 and the protrusion 266, paragraph 0058).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock such that it further comprises a handle with a connector operable to removably attach the handle to the plunger port at a proximal end of the frame, as taught and suggested by Kiev ‘485, for the purpose of providing a suitable structure that grants the user a grip to better handle the assembly (see Kiev ‘485, paragraph 0061).
Regarding claim 18, Breznock fails to teach wherein the handle further comprises a syringe port operable to receive an aspiration syringe.
However, Kiev ‘485 teaches wherein the handle (102) further comprises a syringe port operable to receive an aspiration syringe (paragraph 0116, “To confirm the safety needle 110 is in target 504, the user with attach a fluid drainage device to hub 202”. The hub 202 would be capable of receiving a syringe depending on the connection type. The syringe port of the handle 102 is the area in which port 202 that accepts said syringe is inserted into handle 102).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock such that the handle further comprises a syringe port operable to receive an aspiration syringe, as taught and suggested by Kiev ‘485, for the purpose of providing a suitable structure that allows for a sample of fluid to be drawn into the fluid drainage device to determine if the frame is in the correct location (see Kiev ‘485, paragraph 0116).
Regarding claim 19, Breznock discloses wherein the plunger port is a 1- way valve (paragraph 0055, “the valve or seal 14 is a duckbill or one-way valve”, the valve 14 being a part of the port 24).
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/074191 published as US 20230102684 in view of Breznock, Tanaka, and Kiev ‘485, and further in view of Donaldson
Regarding claim 9, Breznock fails to teach wherein the blade is fluidly connected to the frame.
However, Donaldson teaches a device for treating pneumothorax (abstract) comprising a frame (20) and a probe (50) within the frame (fig. 4, probe 50 within hollow needle 20), wherein the probe (50) is fluidly connected with the frame (fig. 4, ports or openings 54 of the probe 50). While the probe (50) is not a blade, it is similarly used to puncturing the chest wall (abstract)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock such that the blade is fluidly connected to the frame, as taught by Donaldson, for the purpose of providing a suitable structure that allows the device to puncture the chest wall and immediately open a pathway to let fluid flow (see Donaldson, abstract).
Claims 24, 27-28, and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/074191 published as US 20230102684 in view of Breznock, Tanaka, and Kiev, and further in view of Real and Campbell
Regarding claim 24, Breznock discloses wherein the plunger port is configured to connect to a suction source (paragraph 0034), but fails to teach the device further comprising an external check valve assembly operable to connect to the plunger port and a suction source, the external valve assembly being further operable to permit a check valve to be removably inserted into the frame.
However, Real teaches a transcutaneous device for removal of fluid from a body (abstract) that comprises an external check valve assembly (fig. 30, assembly with check valve 163 starting at Luer 160) operable to connect to a suction source (paragraph 0185, “Using the syringe, fluid may be drawn from the patient and pumped into the drainage bag… A syringe may be attached at a flushing port 162 or at a pumping port 164”).
As the plunger port of Breznock is where the suction source is applied, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock such that it further comprises an external check valve assembly operable to connect to the plunger port and a suction source, as taught by Real, for the purpose of providing a suitable structure that permits flow of fluid through the valve only in the proximal direction (see Real, paragraph 0030), thus further preventing back flow of drained fluid.
Breznock, as modified by Real, discloses a check valve in the frame (see Breznock, valve 14 may be a duckbill valve as a well-known check valve, paragraph 0014), but fails to teach wherein the external valve assembly is further operable to permit a check valve to be removably inserted into the frame.
However, Campbell teaches a pneumoseal trocar arrangement (abstract) that suggests that allowing a valve to be inside the trocar or frame while having it be removable is known in the art (paragraph 0015, “The valve may comprise an inner portion of a proximal cap which is fixed or removably attachable to the proximal end of the cannula.)
Campbell is considered analogous art because it pertains to a trocar meant to be inserted into the patient’s body. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock in view of real such that the external valve port is operable to permit a check valve to be removably inserted into the frame, as taught by Campbell, for the purpose of providing a suitable means for the valve to provide a seal and minimize the escape of gas (see Campbell, abstract) and so that the valve can be replaced if damaged, and since it has been held that if were considered desirable to make components separable, it would have been obvious to do so for that desired purpose. See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961), MPEP 2144.04(V)(B).
Regarding claim 31, Breznock fails to teach wherein the external check valve assembly comprises: a connector configured to connect to the plunger port, a valve outlet tubing operably associated with the connector, a check valve operably associated with the valve outlet tubing, and a valve inlet tubing operably connected to the check valve and proximal to the check valve.
However, Real teaches wherein the external check valve assembly comprises: a connector (160) configured to connect to where suction is applied (paragraph 0185, “Using the syringe, fluid may be drawn from the patient and pumped into the drainage bag”), a valve outlet tubing operably associated with the connector (see annotated fig. 30 below), a check valve (163) operably associated with the valve outlet tubing (fig. 30, one-way valve 163, paragraph 0185, “One-way valves 163 are also provided), and a valve inlet tubing operable connected to the check valve (163) and proximal to the check valve (see annotated fig. 30 below).
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As the plunger port of Breznock is where the suction source is applied, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Breznock such that the external check valve assembly comprises a connector configured to connect to the plunger port, a valve tubing operably associated with the connector, a check valve operably associated with the valve outlet tubing, and a valve inlet tubing operable connected to the check valve and proximal to the check valve, as taught by Real, for the purpose of providing a suitable structure that permits flow of fluid through the valve only in the proximal direction (see Real, paragraph 0030).
Claims 27 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/074191 published as US 20230102684 in view of Breznock, Tanaka, and Kiev, and further in view of Real.
Regarding claim 27, Breznock discloses the method comprising connecting a suction source to the plunger port (paragraph 0034, “When the catheter 10 is in use, the manifold 12 connects to a drainage system through the drainage adapter 24… The drainage adapter 24 is capable of being connected to the gravity-fed, pump-driven or vacuum-fed drainage system”) and removing air or fluid or both from the pleural space (paragraph 0037, “Medical personnel push the plunger 42 to force the needle 46 into the thoracic cavity through the muscle, fascia and fat layers of the patient, through the rib space and into the pleural cavity. The trocar 40 is removed and the chest drainage tube 10 is in place.”), but fails to teach the method further comprising: connecting a check valve and a suction source to the plunger port, and removing air or fluid or both from the pleural space.
However, Real teaches a transcutaneous device for removal of fluid from a body (abstract) that connects a check valve assembly (fig. 30, assembly with check valve 163 starting at screw-threaded Luer 160, paragraph 0185) to a suction source (paragraph 0185, “Using the syringe, fluid may be drawn from the patient and pumped into the drainage bag… A syringe may be attached at a flushing port 162 or at a pumping port 164”), and removing air or fluid or both (paragraph 0185, “Using the syringe, fluid may be drawn from the patient and pumped into the drainage bag… A syringe may be attached at a flushing port 162 or at a pumping port 164”).
As the plunger port is the area where suction is applied, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Breznock to include connecting a check valve and a suction source to the plunger port, as taught and suggested by Real, for the purpose of providing a suitable structure that permits flow of fluid through the valve only in the proximal direction (see Real, paragraph 0030), thus further preventing backflow of drained fluid.
Regarding claim 28, Breznock discloses the method further comprising deflating the balloon and removing the rapid deployment chest port from the patient (paragraph 0040, "The balloon inflation fluid is selectively drained from the intracorporeal fixation balloon 18 by opening the stopcock to deflate the balloon 18 and allow the cannula 10 to be removed from the patient’s chest”).
Claim 30 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/074191 published as US 20230102684 in view of Breznock, Tanaka, Kiev ‘485, and Kiev ‘435.
Regarding claim 30, Breznock discloses wherein the rapid deployment chest port is inserted into the pleural space of the patient (paragraph 0018), but fails to teach the method comprising aspirating a volume of air or fluid or both using a syringe attached to a handle of the rapid deployment chest port to confirm placement of the rapid deployment chest port within the pleural space of the patient.
However, Kiev ‘485 teaches a method for access into interior body regions (abstract) that aspirates a volume of air or fluid using a fluid drainage device (104) attached to a handle (102) (fig. 2, handle 102 connected to cannula assembly 104) to confirm placement of the needle within the relevant space (fig. 1, handle assembly 102, fig. 11, needle 110 and hub 202 attached to handle configured to have fluid drainage device attached to it to confirm that the needle 110 is in the correct space, paragraph 0116)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Breznock such that it comprises aspirating a volume of air or fluid using a suction device attached to a handle of the rapid deployment chest port to confirm placement of the rapid deployment chest port within the pleural space of the patient, as taught and suggested by Kiev ‘485, for the purpose of providing a suitable method that confirms that the port is in the correct space (see Kiev, paragraph 0116).
Breznock, as modified by Kiev ‘485, is silent to teach wherein the suction device is a syringe.
However, Kiev ‘435 teaches a similar method of confirming if the needle is in the correct location that uses a syringe as a fluid drainage device (paragraph 0043, “Fluid drainage devices that may be used include syringes”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Breznock in view of Kiev ‘485 such that the suction device is a syringe, as taught by Kiev ‘435, for the purpose of providing a suitable structure that can suction fluid to confirm if the assembly is in the correct location (see Kiev ‘435, paragraph 0043).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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/Brandon W. Levy/Examiner, Art Unit 3781
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