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 .
Status of the Claims
The amendment filed 11/28/2025 has been entered. Claims 1-22 are pending and under consideration.
Response to Arguments
In response to applicant’s argument, pages 12-13, with respect to the claim rejections 1-4 and 7-8 under 35 USC 103 over Kornel (US 20240197980 A1) in view of Lazarus (US 20130211385 A1) that the prior art differs from the claimed invention as the Kornel is placed before the surgeon proceeds with closure of the cavity, while the claimed invention permits fluid removal after closure of an incision of cavity.
This is not found persuasive for the following reasons. First, applicant does not expressly identify which claim limitations are not met by the prior art references. Furthermore, the claim does not require that the device of claim 1 be inserted before or after closure of the incision or open wound, contrary to applicant’s position. Applicant’s argument is directed solely to intended-use/functional language. Kornel teaches a catheter comprising one or more sponges connected to its first end encapsulated by a removable covering layer (see figure 1), which is fully capable of performing the function asserted by applicant.
In response to applicant’s argument, pages 13-14, with respect to the claim rejection 1-4 and 7-8 under 35 USC 103 over Kornel (US 20240197980 A1) in view of Lazarus (US 20130211385 A1) that the Kornel does not teach “microporous sponges” have been considered and is at least partially persuasive, but are moot in light of new rejection/interpretation.
In response to applicant’s argument, pages 14-15, that the Lazarus fails to teach the claimed “wherein the percutaneous catheter is configured to curve at the first end, such that the one or more microporous sponges adapt to the curve” because Lazarus does not teach claimed curve so “that the one or more microporous sponges adapted to the curve”.
This is not found persuasive. Kornel teaches that the catheter (figures 1 a-c and [0070], 106 made of flexible and malleable material) is configured to be curved at the first end, and the catheter comprising a flexible sponge element (figures 1a-c [0017-0018], sponge element 112 being compressible and flexible) mounted on the first end of the catheter. These features enables allowing the sponge to adapt and follow any curvature of the catheter.
In response to applicant’s argument, page 15, with respect to dependent claims 2-3 that the prior art fails to teach a catheter having one or more microporous sponges have been considered and is at least partially persuasive, but are moot in light of new rejection/interpretation.
In response to applicant’s argument, pages 15-18, with respect to the claim rejection 5 is at least partially persuasive, but are moot in light of new rejection/interpretation.
In response to applicant’s argument, pages 18-20, with respect to the claim rejection 6 that Radl does not teach wherein the cover layer is composed of absorbable cellulose, because Radl teaches, at most, a cover 22B for urine collection in the urethra of a female patient. There is no “cover layer” of “one or more microporous sponges”, and the supposed teachings of Radl only appear to be combinable with those of Kornel in view of Lazarus in light of the claimed invention. To do so would amount to impermissible hindsight bias.
This is not found persuasive. Radl is not relied upon to teach the microporous sponges or the overall structure of the cover layer; those elements are expressly taught by the primary reference Kornel. Radl is cited solely for its teaching that a cover layer is a catheter system for fluid removal can be formed of a liquid-permeable, absorbent hydrophilic material such as cellulose ([0073]). One of ordinary sill in the art would have found it obvious to form the removable cover layer of Kornel with absorbable cellulose as suggested by Radl because Radl teaches cellulose as a suitable known material for a liquid-permeable, absorbent cover in a medical catheter device for fluid management. The combination applied a known material (absorbable hydrophilic cellulose material of Radl configured for body cavity insertion) to a known device (catheter for body cavity insertion) for the known purpose to achieve predictable result (providing hydrophilic surface as taught by Radl [0073] thereby reducing friction). The fact that Radl is an external female urinary catheter does not render the combination impermissible hindsight. Both Kornel and Radl directed to the analogous art of catheters and drainage system for removing fluid from a patient. A person of ordinary skill seeking to improve the cover of Kornel would look to the absorbable cellulose of Radl for the purpose of providing hydrophilic surface as taught by Radl ([0073]) thereby reducing friction and modifying the cove material is routine skill in the art with a reasonable expectation of success and highly predictable.
In response to applicant’s argument, pages 20-22, with respect to the claim rejection 9-10 and 12 that Loske fails to teach the claimed “wherein the apparatus applies continuous or intermittent negative pressure into both the lumen and the sponge when the fluid removal device is inserted into the body cavity of the patient” Loske only teaches at most a vacuum pump for applying the fluid communication member.
This is not found persuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Kornel expressly teaches an apparatus (Kornel; [0069] proximal end of catheter 106 may be attached to suction source) is attached to the proximal end of the catheter (the fluid removal device) that applies negative pressure into both the catheter lumen and the sponge when the device is inserted into the body cavity or wound. Loske is relied upon to teach that it was well-known in the art, at the time of the invention, to apply negative pressure to a sponge drainage system in continuous or intermittent mode (see Loske [0030]) One of skill in the art would have found it obvious to modify the suction apparatus of Kornel to operate in the continuous or intermittent mode taught by Loske because both references are directed to vacuum sponge drainage system for removing fluid from body cavity/wounds, and applying a known technique (providing intermittent or continuous vacuum mode)to a known device (suction device) for improvement yields only predictable results.
There are no distinct argument directed to claims 11 and 13-14
In response to applicant’s argument with respect to claims rejection 15-18 that Kornel fails to teach “that an opening of the percutaneous catheter disposed nearest the microporous sponge extends outside of the microporous sponge” is at least partially persuasive but are moot in light or new rejection/interpretation.
There are no distinct argument directed to claims 21 and 22.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 7, 8, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kornel (US 20240197980 A1, provisional effectively filed 04/06/2021) in view of Siedle et al (EP 2394677 A1)
Regarding claim 1, Kornel substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
a device (figures 1-10, catheter 106 with a sponge element 112 and a sponge housing 116) for removing fluid from a body cavity of a patient, the device comprising:
a percutaneous catheter (figure 1a, catheter 106) comprising a first end (figure 1a, distal catheter section 108), a second end (figure 1a and [0073] opposite proximal end of the catheter), and a lumen ([0069 and 0079] lumen within the catheter extending between the proximal and distal ends) disposed in an interior of the percutaneous catheter from the first end to the second end, the first end comprising a tip (figure 1a, tip of catheter at the distal end) and a plurality of holes (figure 1a and [0069] one or more perforations 108a) fluidly connected to the lumen;
one or more microporous sponges (figure 1a and [0023-0025] flexible sponge 112 physically connected/disposed and covers an on exterior surface to the distal end) physically connected to the first end of the percutaneous catheter and disposed on an exterior surface of the first end such that the one or more microporous sponges cover at least a portion of the first end; and
a cover layer (figure 10a, sponge housing 116) covering an outer surface of the one or more microporous sponges,
wherein the percutaneous catheter is configured to curve at the first end, wherein the one or more microporous sponges are flexible such that the one or more microporous sponges adapt to the curve ([0017, 0070] and figure 2a-c, the catheter and sponge are formed of a flexible material and configured to curve when advanced within and along curvature of the lumen 100), and
wherein the cover layer comprises one or more releasable portions (figures 10a-c, opening of housing 116, the opening allow removal of the housing after following insertion of the sponge into the body cavity) that are configured to allow the cover layer to be removed after insertion of the percutaneous catheter and the one or more microporous sponges into the body cavity of the patient.
Kornel does not expressly teach the one or more sponges are microporous.
In the same field of endeavor, namely a medical product for removing body liquids from human cavities, Siedle teaches the one or more sponges are microporous ([0066] absorbent body preferably have a pore size between 400 um to 600 um, such pore size is considered microporous )
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kornel to incorporate the teachings of Siedle and provide the microporous sponges for the purpose of effectively removing body liquid such as wound secretions by distributing desired negative pressure for fluid removal as taught by Siedle ([0002 and 0070]).
Regarding claim 2, Kornel, as modified by Siedle, teaches the device of claim 1.
The combination further teaches wherein at least one sponge of the one or more microporous sponges comprises a hollow center (Kornel; figures 1a-c, inner hollow center of the sponge where the catheter 106 is inserted), and wherein the hollow center fits around an outer circumference of the first end of the percutaneous catheter (Kornel; sponge 112 fits around an outer circumference of the distal catheter section 108)
Regarding claim 3, Kornel, as modified by Siedle, teaches the device of claim 1.
The combination further teaches wherein at least one sponge of the one or more microporous sponges physically covers the plurality of holes (Kornel; figure 1a, the sponge 112 physically covers holes 108)
Regarding claim 4, Kornel, as modified by Siedle, teaches the device of claim 1.
The combination further teaches wherein the one or more microporous sponges are composed of polyurethane and/or gelatin (Kornel; [0071] sponge element 112 is composed of polyurethane).
Regarding Claim 7, Kornel, as modified by Siedle, teaches the device of claim 1.
The combination further teaches wherein the cover layer constricts a maximum diameter of the one or more microporous sponges (Kornel; [0026]-[0027], [0080], figures 1a-c and 10a-c, the sponge housing 116 restricts the sponge element 112 in a compressed state prior to insertion, as shown figures 1a and 10a, and removal of the housing allows the sponge to expand to its maximum diameter, as shown figures 1c and 10c), and wherein removal of the cover layer results in the one or more microporous sponges expanding to the maximum diameter.
Regarding Claim 8, Kornel, as modified by Siedle, teaches the device of claim 1.
The combination further teaches wherein the second end of the percutaneous catheter is physically connected to an apparatus that provides suction through the lumen of the percutaneous catheter (Kornel; [0069] proximal end of the catheter 106 is configured to be attached suction source).
Regarding Claim 15, Kornel teaches a method for removing fluid from a body cavity of a patient, the method comprising:
inserting a fluid removal device into the body cavity of the patient (figure 1-1 and [0077] inserting a catheter 106 comprising sponge element 112 deployed into patient body), the fluid removal device comprising:
a percutaneous catheter comprising a lumen (figure 1a and [0069] and [0079], catheter 106 comprising a lumen formed therein), and
a microporous sponge (figure 1a and [0023]-[0025], sponge element 112 attached around an outer circumference of the catheter 106) attached around an outer circumference of the percutaneous catheter such that an opening of the percutaneous catheter disposed nearest the microporous sponge extends outside of the microporous sponge (figure 1a and [0069] plurality of perforations 108a disposed nearest the sponge element, i.e., inner surface of sponge element adjacent the perforations 108a, and fluidically extends outside of the sponge element), the microporous sponge fluidly connected to the lumen (figure 1a, [0069] and 0072, inner lumen within the catheter fluidly connected to the sponge element 112 through one or more perforations 108a);
applying negative pressure to the fluid removal device via a suction apparatus ([0069] suction source attached to the catheter to establish negative pressure in the catheter);
conducting the fluid to be removed from the body cavity of the patient into the microporous sponge and into the lumen, thereby removing the fluid from the body cavity of the patient ([0069] fluid drawn into the sponge element 112 and then passes into and up to catheter 106, and removed from patient ).
Kornel does not expressly teach the sponge is microporous.
In the same field of endeavor, namely a medical product for removing body liquids from human cavities, Siedle teaches the one or more sponges are microporous ([0066] absorbent body preferably have a pore size between 400 um to 600 um, such pore size is considered microporous )
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kornel to incorporate the teachings of Siedle and provide the microporous sponges for the purpose of effectively removing body liquid such as wound secretions by distributing desired negative pressure for fluid removal as taught by Siedle ([0002 and 0070]).
Regarding claim 16, Kornel, as modified by Siedle, teaches the method of claim 15.
The combination further teaches wherein the percutaneous catheter comprises a plurality of holes (Kornel; figure 1a and [0069] and [0072] one or more perforation 108a fluidly connect the lumen of the catheter 106 and the sponge element 112) fluidly connecting the lumen with the microporous sponge, and wherein the microporous sponge is in a shape of a hollow cylinder (Kornel; see figure 1a, sponge element 112 having cylinder shape and inner hollow space for wrapping around catheter 106).
Regarding Claim 17, Kornel, as modified by Siedle, teaches the method of claim 16.
The combination further teaches wherein the fluid to be removed from the body cavity of the patient is absorbed into the sponge and then passed from the sponge into the lumen via the plurality of holes (Kornel; [0069] fluid drawn into the sponge element 112 and then passes into and up to catheter 106 through the one or more perforations 108a)
Regarding Claim 18, Kornel, as modified by Siedle, teaches the method of claim 15.
The combination further teaches wherein the applying the negative pressure further comprises: activating the suction apparatus to exert the negative pressure into the lumen and the sponge (Kornel; [0069] [0075], connecting suction source to proximal end of the catheter 106 and exert negative pressure into the lumen of the catheter 106 and further sponge element 112).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kornel (US 20240197980 A1, provisional effectively filed 04/06/2021) in view of Siedle et al (EP 2394677 A1), and in further view of Jacobsen et al (US 6398758 B1)
Regarding claim 5, Kornel, as modified by Siedle, teaches the device of claim 1.
The combination does not teach wherein the one or more releasable portions are physically connected to one or more sutures such that exertion force on the one or more sutures causes the cover layer to be removed.
In the same field of endeavor, namely a medicament delivery system, Jacobsen teaches wherein the one or more releasable portions (figures 2a-b, sheath 30) are physically connected to one or more sutures (figures 2a-b col 4 line 50 col 5 line 45, filament 36 connected to sheath 30, pulling the filament 36 break the seal of the sheath 30 and removes the sheath from foam cylinder 42) such that exertion force on the one or more sutures causes the cover layer to be removed.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kornel, as modified by Siedle, to incorporate the teachings of Jacobsen and provides the one or more sutures as claimed for the purpose of facilitating delivery of the flexible and expandable microporous sponges at the target location as taught by Jacobsen (col 4 line 50-col 5line 45)
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kornel (US 20240197980 A1) in view of Siedle et al (EP 2394677 A1), and in further view of Radl et al (US 20220280711 A1).
Regarding claim 6, Kornel, as modified by Siedle, teaches the device of claim 1.
The combination does not teach wherein the cover layer is composed of absorbable cellulose.
In the same field of endeavor, namely female catheter system, Radl teaches a cover layer (figure 3, cover 22b) is composed of absorbable cellulose ([0073] cover 232b is formed of a liquid permeable material, preferably on that is absorbent and hydrophilic, e.g., cellulose).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kornel, as modified by Siedle, to incorporate the teachings of Radl and provide the cover layer as claimed, and one of skill in the art motivated to do so, for the purpose of providing hydrophilic surface as taught by Radl (abstract) so as to reduce friction with the tissue site during insertion.
Claims 9, 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kornel (US 20240197980 A1, provisional effectively filed 04/06/2021) in view of Loske et al (US 20200360578 A1).
Regarding claim 9, Kornel teaches a system for removing fluid from a body cavity of a patient, the system comprising:
a fluid removal device (figures 1-10, catheter 106 with a sponge element 112 and a sponge housing 116) comprising a percutaneous catheter (figure 1, catheter 106) and a sponge (figure 1a and [0072] sponge element 112 attached at distal catheter section 108 around an outer circumference is configured to be inserted within body cavity) attached around an outer circumference of the percutaneous catheter at an end of the percutaneous catheter configured to be inserted into the a body cavity of the patient; and
an apparatus ([0069] suction source attached to a proximal end of the catheter 106) attached to the fluid removal device,
wherein the percutaneous catheter comprises a lumen that is fluidly connected to the sponge ([0069] and [0079] inner lumen defined within the catheter fluidly connects the sponge element 112 to the suction source through one or more perforations 108a),
wherein the apparatus applies continuous or intermittent negative pressure into both the lumen and the sponge when the fluid removal device is inserted into the body cavity of the patient ([0069] the suction source applies negative pressure to the sponge element 112 through the lumen of the catheter when the sponge element is inserted into the body cavity), wherein the apparatus comprises a vacuum device, a negative pressure device, and/or a pump ([0069] suction source).
Kornel does not expressly teach wherein the apparatus applies continuous or intermittent negative pressure.
In the same field of endeavor, namely a vacuum sponge drainage, Loske teaches wherein the apparatus applies continuous or intermittent negative pressure ([0048] vacuum pump provide intermittent negative pressure through drainage tube 20 and sponge 10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kornel to incorporate the teachings of Loske and provides the apparatus as claimed for the purpose of preventing potential pressure injury the tissue as taught by Loske ([0048]).
Regarding Claim 10, Kornel, as modified by Loske, teaches the system of claim 9.
The combination further teaches wherein the sponge is absorbable such that the sponge absorbs the fluid from the body cavity of the patient and passes the fluid into the lumen of the percutaneous catheter (Kornel; [0074] "the sponge element 112 may absorb fluid which may then be removed from the user's body and the sponge element via the catheter 106").
Regarding Claim 12, Kornel, as modified by Loske, teaches the system of claim 9.
The combination does not expressly teach wherein the negative pressure is in a range from -100 mm Hg to -150 mm Hg; though,
Loske teaches wherein the negative pressure is in a range from -80 and -125 mm Hg ([0048]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kornel, as modified by Loske, and provides the negative pressure as claimed since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” (MPEP 2144.05(I)). In the instant case, the applicant has not shown unexpected result gleaming from the claimed range (specification [0091]), and therefore the claimed device is not patentably distinct from the prior art.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kornel (US 20240197980 A1, provisional effectively filed 04/06/2021) in view of Loske et al (US 20200360578 A1), and in further view of McKay (US 20110184338 A1)
Regarding Claim 11, Kornel, as modified by Loske, teaches the system of claim 9.
The combination does not teach further comprising one or more collection bags for collecting the fluid from the body cavity of the patient.
In the same field of endeavor, namely catheter devices and drainage system, McKay teaches a system (figure 1, drainage and drug delivery system 10) comprising one or more collection bags for collecting the fluid from the body cavity of the patient ([0020] other end of catheter is generally connected to a collection device such as a drainage bag).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kornel, as modified by Loske, to incorporate the teachings of McKay, and provide the one or more collection bags as claimed for the purpose of safely collecting drainage fluid from tissue site, as taught by McKay ([0009]), and to prevent contamination by the collected waste.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kornel (US 20240197980 A1, provisional effectively filed 04/06/2021) in view of Loske et al (US 20200360578 A1), and in further view of Radl et al (US 20220280711 A1).
Regarding Claim 13, Kornel, as modified by Loske, teaches the system of claim 9.
The combination further teaches wherein the fluid removal device further comprises an outer layer, the outer layer attached to an outer surface of the sponge (Kornel; figure 10a, sponge housing 116 attached to an outer surface of the sponge element 112).
The combination does not teach the outer layer is absorbable cellulose.
In the same field of endeavor, namely female catheter system, Radl teaches a cover layer (figure 3, cover 22b) is composed of absorbable cellulose ([0073], cover 232b is formed of a liquid permeable material, preferably on that is absorbent and hydrophilic, e.g., cellulose).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kornel, as modified by Loske, to incorporate the teachings of Radl and provide the outer layer as claimed, and one of skill in the art motivated to do so, for the purpose of providing hydrophilic surface coating as taught by Radl (abstract) so as to reduce friction with the tissue site during insertion.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kornel (US 20240197980 A1, provisional effectively filed 04/06/2021) in view of Loske et al (US 20200360578 A1) and Radl et al (US 20220280711 A1), and in further view of Jacobsen et al (US 6398758 B1)
Regarding Claim 14, Kornel, as modified by Loske and Radl, teaches the system of claim 13.
The combination does not teach wherein the outer layer further comprises a pre-cut section attached to a suture such that exertion of force in the suture removes the pre-cut section and releases the outer layer from the outer surface of the sponge.
In the same field of endeavor, namely a medicament delivery system, Jacobsen teaches the outer layer (figure 3a, sheath 30a) further comprises a pre-cut section (figure 3 and col 7 lines 29-35 weakened region 66 comprising a line of full depth perforations attached to a rip cord filament 64) attached to a suture (figure 3, rip cord filament 64) such that exertion of force in the suture removes the pre-cut section and releases the outer layer from the outer surface of the sponge (col 7 lines 9 – 34, pulling the rip cord causes the seal to break and the sheath removed from foam cylinder)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kornel, as modified by Loske and Radl, to incorporate the teachings of Jacobsen and provides the outer layer as claimed for the purpose of facilitating delivery of the expandable one or more microporous sponges at the target location as taught by Jacobsen (col 4 line 50-col 5line 45)
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kornel (US 20240197980 A1) in view of Siedle et al (EP 2394677 A1), and in further view of Loske et al (US 20200360578 A1).
Regarding claim 19, Kornel, as modified by Siedle, teaches the system of claim 9.
The combination does not expressly teach wherein the negative pressure is in a range from -100 mm Hg to -150 mm Hg;
Locke teaches wherein the negative pressure is in a range from -80 and -125 mm Hg ([0048]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kornel, as modified by Loske, and provides the negative pressure as claimed for the purpose of preventing potential pressure injury to the tissue as taught by Loske ([0048]), and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” (MPEP 2144.05(I)). In the instant case, the applicant has not shown unexpected result gleaming from the claimed range (specification [0091]), and therefore the claimed device is not patentably distinct from the prior art.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kornel (US 20240197980 A1) in view of Siedle et al (EP 2394677 A1), and in further view of McKay (US 20110184338 A1)
Regarding Claim 20, Kornel, as modified by Siedle, teaches the method of claim 15.
Kornel does not teach further comprising collecting the fluid removed from the body cavity of the patient in one or more collection devices.
In the same field of endeavor, namely catheter devices and drainage system, McKay teaches collecting the fluid removed from the body cavity of the patient in one or more collection devices ([0020] other end of catheter is connected to a collection device for collecting the fluid removed through the catheter).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kornel to incorporate the teachings of McKay, and provide the one or more collection bags as claimed for the purpose of safely collecting drainage fluid from tissue site, as taught by McKay ([0009]), and to prevent contamination by the collected waste.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Kornel (US 20240197980 A1) in view of Siedle et al (EP 2394677 A1), and in further view of Lazarus (US 20130211385 A1).
Regarding claim 21, Kornel, as modified by Siedle, teaches the device of claim 1.
The combination does not teach wherein the percutaneous catheter is configured to physically connect to a guidewire to insert the device into the body cavity via an imaging device.
In the same field of endeavor, namely a body cavity drainage devices and related methods, Lazarus teaches wherein the percutaneous catheter is configured to physically connect to a guidewire ([0058-0061] and figures 7-10, drainage tube comprises at least one wire, for example figure 7 wire 72. Further [0079] teaches utilizing imaging device estimating size and shape of body cavity, and that these estimations are then used to determine the appropriate range of movement of the catheter. Because the range of movement is selected based on the imaging-derived estimation of the cavity, the imaging device facilitate and enables the insertion of the device into the cavity via the guidewire).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kornel, as modified by Siedle, to incorporate the teachings of Lazarus and provide the percutaneous catheter as claimed for the purpose of facilitating movement of the drainage tube after insertion thereof, thereby allowing the drainage tube to reach desired locations within the body cavity as taught by Lazarus ([0011][0058])
Regarding claim 22, Kornel, as modified by Siedle, teaches the device of claim 1.
The combination does not teach wherein the curve is configured to be introduced after the percutaneous catheter is inserted into the body cavity.
In the same field of endeavor, namely a body cavity drainage devices and related methods, Lazarus teaches wherein the curve is configured to be introduced after the percutaneous catheter is inserted into the body cavity ([0079] “After insertion into the body cavity, the distal end of the drainage tube may be moved within the body cavity according to the preselected range of movement to facilitate a specific treatment.” The movement including curve as shown figures 5 and 6.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kornel, as modified by Siedle, to incorporate the teachings of Lazarus and provide the percutaneous catheter as claimed for the purpose of facilitating movement of the drainage tube after insertion thereof, thereby allowing the drainage tube to reach desired locations within the body cavity as taught by Lazarus ([0011][0058])
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 SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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/S.H./Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781