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 Claims
Claims 1-18 are pending and currently under consideration for patentability.
Response to Arguments
Applicant's arguments filed 6/19/2025 have been fully considered but they are not persuasive.
In response to the applicant’s argument that Cohen fails to teach the uniform diameter, the examiner agrees which is why Meadows is relied upon for this combination of references. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Meadow is only used to teach wherein said predetermined internal diameter of said first end and said second end comprises a substantially uniform internal diameter void of additional elements. Meadows is only used to provide motivation to modify Cohen.
In response to the applicant’s argument that Meadows is not void of additional elements and the combination could not work with wire, the examiner disagrees. The wire does not impede drainage and in fact the wire supports the motivation to keep the lumen clear. There is no evidence that the wire would impede drainage, however the lack of valves protruding into the lumen are beneficial to prevent blockage.
In response to applicant's argument that Fischell is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the fact that the catheter is an intravascular catheter does not take away from the combination. Since the device is still used as a catheter as the catheter of Fischell is being used to modify the Cohen to prevent clogging. This is a useful feature to be used in both circumstances.
In response to applicant's argument that Kick is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case Kick functions as a drainage catheter so adding the holes across from the port would still be obvious as the motivation still applies.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (US 6162201 A) in view of Fischell (US 20140358079 A1) in view of Meadows (US 20200306141 A1).
Regarding Claim 1, Cohen discloses a uniform internal diameter drainage device (column 10, line 2) comprising:
a multi-direction hub(catheter, 10) (column 5, lines 9-10) comprising: a first end (14) comprising a predetermined internal diameter (sized for placement into urethra, column 3, lines 45-49) and terminating in a first receiving port (urine inlet, 52)(figure 1);
a second end (18) comprising said predetermined internal diameter (same diameter as catheter, figure 1) and terminating in an engaging port (sleeve, 40) (column 4, lines 17-29) (figures 1 and 2);
a valve (22) between said first end (14) and said second end (18) (figure 1), said valve (22b) comprising a directional flow apparatus (push member, 68) to operate said valve (22) to determine a direction of flow (column 5, lines 9-10); and
wherein said predetermined internal diameter (sized for placement into urethra, column 3, lines 45-49) of said first end (14) and said second end (18) comprise substantially uniform internal diameter (column 3, lines 54-56).
Cohen fails to teach a flush port adjacent said valve and in fluid communication with said first end and said second end through said valve. In the same field of endeavor, namely the medical catheters, Fischell teaches a catheter (600) wherein a flush port (Luer port 634) is in fluid communication with said first end and said second end within said predetermined internal diameter (paragraph [0296]) (figure 33). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter system of Cohen to include a flush port similar to that disclosed by Fischell to ensure that the tube remains clean and unclogged for drainage and continued use (as motivated by Fischell, paragraph [0297]).
Cohen and Fischell fail to teach wherein said predetermined internal diameter of said first end and said second end comprises a substantially uniform internal diameter void of additional elements.
Meadows teaches uniform internal diameter drainage device wherein said predetermined internal diameter of said first end and said second end comprises a substantially uniform internal diameter (82) (paragraph [0049]) void of additional elements (paragraph [0055])(figure 4). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify internal diameter of Cohen so the predetermined internal diameter of said first end and said second end comprises a substantially uniform internal diameter void of additional elements to avoid blockage.
Regarding Claim 18, Cohen teaches a three direction catheter hub (catheter, 10) (column 10, line 2) (column 5, lines 9-10) for draining fluids from a patient comprising:
a first end (14) comprising a first receiving port (urine inlet, 52)(figure 1) with a releasing mechanism (bladder retention balloon, 24), said first receiving port (urine inlet, 52)(figure 1) attachable to an engaging port (sleeve, 40) (column 4, lines 17-29) (figures 1 and 2) of a catheter line (catheter, 10) leading to a drainage apparatus (force receiving portion 210);
a second end (18) comprising an engaging port (sleeve, 40) (column 4, lines 17-29) (figures 1 and 2) attachable to a receiving port of a catheter line (catheter, 10) leading to a drainage site within said patient (column 3, lines 45-49);
a valve (22) between said first end (14) and said second end (18) (figure 1), said valve (22b) comprising a directional flow apparatus (push member, 68) to operate said valve (22) to determine a direction of flow (column 5, lines 9-10); and
Cohen fails to teach a flush port comprising said predetermined internal diameter adjacent said valve and in fluid communication with said valve; wherein said first end, said second end, and said flush port comprise substantially uniform predetermined interior diameter. In the same field of endeavor, namely the medical catheters, Fischell teaches a catheter (600) wherein a flush port (Luer port 634) is in fluid communication with said first end and said second end within said predetermined internal diameter (paragraph [0296]) (figure 33). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter system of Cohen to include a flush port similar to that disclosed by Fischell to ensure that the tube remains clean and unclogged for drainage and continued use (as motivated by Fischell, paragraph [0297]).
Cohen and Fischell fail to teach wherein said predetermined internal diameter of said first end and said second end comprises a substantially uniform internal diameter void of additional elements.
Meadows teaches uniform internal diameter drainage device (82) wherein said predetermined internal diameter of said first end and said second end comprises a substantially uniform internal diameter (paragraph [0049]) void of additional elements (paragraph [0055])(figure 4). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify internal diameter of Cohen so the predetermined internal diameter of said first end and said second end comprises a substantially uniform internal diameter void of additional elements to avoid blockage.
Claim(s) 2, 3, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (US 6162201 A) in view of Fischell (US 20140358079 A1) in view of Meadows (US 20200306141 A1) in view of Kick (US 20060135962 A1).
Regarding Claim 2, Cohen in view of Fischell and Meadows teaches a uniform internal diameter drainage device as set forth in claim 1. Cohen further teaches a catheter (catheter, 10), said catheter (10) comprising a receiving port (52) in fluid-tight communication (column 6, lines 1-2) with said engaging port (40) of said second end (18) of said drainage device (force receiving portion 210); and
wherein said catheter (10) has a predetermined internal diameter (sized for placement into urethra, column 3, lines 45-49) substantially uniform to said predetermined internal diameter of said first end (14) and said second end (18) of said drainage device (column 3, lines 54-56).
Cohen and Fischell fail to teach wherein the catheter terminates along a portion opposite said receiving port in a plurality of drainage apertures. In the same field of endeavor, namely drainage catheters, Kick teaches a catheter terminating along a portion opposite said receiving port in a plurality of drainage apertures (drainage holes or ports 1006) (paragraph [0086]) (figures 17C). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter of Cohen in view of Fischell to include a plurality of drainage apertures similar to that disclosed by Kick so that more fluid may be drained from more locations at a time to expedite the drainage process.
Regarding Claim 3, Cohen in view of Fischell and Meadows and Kick teaches a uniform internal diameter drainage device as set forth in claim 2. Cohen further teaches a fluid drainage line (valve passage, 200) comprising an engaging port (40) in fluid-tight communication (column 6, lines 8-10) with said receiving port (22a) ( column 8, lines 15-35) of said drainage device, and in fluid-tight communication (column 6, lines 8-10) along an end opposite said engaging port (40) with a drainage receptacle (receiving portion, 210) ; and
wherein said drainage line (200) has a predetermined internal diameter substantially uniform to said predetermined internal diameter of said first end and said second end of said drainage device (figure 3 and 13: 78, 80 and 200 are all the same diameter).
Regarding Claim 11, Cohen teaches a system for reducing fluid blockage in a catheter (column 10, line 2) draining fluid from a patient comprising:
a catheter (600) for insertion into a patient to drain said fluid therefrom, said catheter (600) comprising a predetermined internal diameter (sized for placement into urethra, column 3, lines 45-49) (figures 1 and 2).
a drainage line (valve passage, 200) comprising an engaging port (40) along a first end and in fluid communication with a drainage receptacle adjacent its second end, said drainage line (valve passage, 200) comprising a predetermined internal diameter (sized for placement into urethra, column 3, lines 45-49) substantially uniform with said internal diameter of said catheter (figure 3 and 13: 78, 80 and 200 are all the same diameter); and
a central hub (column 5, lines 9-10) comprising:
a first end (14) comprising a receiving port (52) and connected to said drainage line by engaging said engaging port (40) (column 4, lines 17-29) (figures 1 and 2) of said drainage line to create a fluid-tight connection (column 4, lines 17-29);
a second end (18) opposite said first end and comprising an engaging port connected to said receiving port ( 52)(figure 1)of said catheter to create a fluid-tight connection (column 6, lines 8-10);
a valve (22) between said first end (14) and said second end (18) (figure 1), said valve (22b) comprising a directional flow apparatus to operate said valve (22) to determine a direction of flow (column 5, lines 9-10); and
wherein said predetermined internal diameter (sized for placement into urethra, column 3, lines 45-49) of said first end (14) and said second end (18) comprise substantially uniform internal diameter (column 3, lines 54-56).
Cohen fails to teach a flush port adjacent said valve and in fluid communication with said first end and said second end within said predetermined internal diameter. In the same field of endeavor, namely the medical catheters, Fischell teaches a catheter (600) wherein a flush port (Luer port 634) in fluid communication with said first end and said second end within said predetermined internal diameter (paragraph [0296]) (figure 33). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter system of Cohen to include a flush port similar to that disclosed by Fischell to ensure that the tube remains clean and unclogged for drainage and continued use (as motivated by Fischell, paragraph [0297]).
Cohen and Fischell fail to teach wherein terminating along a portion opposite said receiving port in a plurality of drainage apertures. In the same field of endeavor, namely drainage catheters, Kick teaches a catheter terminating along a portion opposite said receiving port in a plurality of drainage apertures (drainage holes or ports 1006) (paragraph [0086]) (figures 17C). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter of Cohen in view of Fischell to include a plurality of drainage apertures similar to that disclosed by Kick so that more fluid may be drained from more locations at a time to expedite the drainage process.
Regarding Claim 12, Cohen in view of Fischell and Meadows and Kick teaches a uniform internal diameter drainage device as set forth in claim 11. Cohen further teaches: said receiving port (valve mechanism, 52) of said first end of said drainage device (figure 3) comprises an externally annular attachment mechanism (annular collars 54, 56), an internal annular recess (84) and an annular shoulder (54); and
said engaging port (78) of said first end (54) comprises a chamfered connection surface (62) (figure 4) on its distal end engaging said annular shoulder (figure 3), and an annular ring engaging (Column 6, lines 8-10: Diaphragm 88 is preferably a ring-shaped member sized to provided sealing contact with valve passage 52 and tubular portion 82) said annular recess (84) to form said fluid-tight connection (column 6, lines 8-10).
Cohen fails to teach wherein the attachment mechanism is snap and release. In the same field of endeavor, namely catheter hubs, Sakaguchi teaches a catheter hub wherein the attachment mechanism is snap and release (claim 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the attachment mechanism of Cohen that allows the catheter and valve to connect and disconnect, for the snap and release mechanism of Sakaguchi since these mechanisms perform the same function of attaching multiple pieces together. Simply substituting one attachment means for another would yield the predicable result of allowing the catheter and valve to attach and reattach by snap and release. See MPEP 2143.
Claim(s) 4-6, 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (US 6162201 A) in view of Fischell (US 20140358079 A1) in view of Meadows (US 20200306141 A1) in view of Kick (US 20060135962 A1) as applied to claim 3 and 12 above, and further in view of Sakaguchi (US 11331450 B2).
Regarding Claim 4, Cohen in view of Fischell and Meadows and Kick teaches a uniform internal diameter drainage device as set forth in claim 3. Cohen further teaches: said receiving port (valve mechanism, 52) of said first end of said drainage device (figure 3) comprises an externally annular attachment mechanism (annular collars 54, 56), an internal annular recess (84) and an annular shoulder (54); and
said engaging port (78) of said first end (54) comprises a chamfered connection surface on its distal end engaging said annular shoulder (figure 3), and an annular ring (Column 6, lines 8-10: Diaphragm 88 is preferably a ring-shaped member sized to provided sealing contact with valve passage 52 and tubular portion 82) said annular recess (84) to form said fluid-tight connection (column 6, lines 8-10).
engaging said annular recess to form said fluid-tight connection (column 6, lines 8-10).
Cohen, Fischell and Kick fail to teach wherein the attachment mechanism is snap and release. In the same field of endeavor, namely catheter hubs, Sakaguchi teaches a catheter hub wherein the attachment mechanism is snap and release (claim 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the attachment mechanism of Cohen that allows the catheter and valve to connect and disconnect, for the snap and release mechanism of Sakaguchi since these mechanisms perform the same function of attaching multiple pieces together. Simply substituting one attachment means for another would yield the predicable result of allowing the catheter and valve to attach and reattach by snap and release. See MPEP 2143.
Regarding Claim 5, Cohen in view of Fischell, and Meadows, and Kick and Sakaguchi teaches a uniform internal diameter drainage device as set forth in claim 4. Cohen further teaches: said receiving port (valve mechanism, 52) of said first end of said drainage device (figure 3) comprises an externally annular attachment mechanism (annular collars 54, 56), an internal annular recess (84) and an annular shoulder (54);
said engaging port (78) of said second end (56) comprises a chamfered connection surface on its distal end engaging said annular shoulder (figure 3), and an annular ring engaging (Column 6, lines 8-10: Diaphragm 88 is preferably a ring-shaped member sized to provided sealing contact with valve passage 52 and tubular portion 82) said annular recess (84) to form said fluid-tight connection (column 6, lines 8-10).
said annular recess to form said fluid-tight connection (column 6, lines 8-10).
Cohen fails to teach wherein the attachment mechanism is snap and release. In the same field of endeavor, namely catheter hubs, Sakaguchi teaches a catheter hub wherein the attachment mechanism is snap and release (claim 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the attachment mechanism of Cohen that allows the catheter and valve to connect and disconnect, for the snap and release mechanism of Sakaguchi since these mechanisms perform the same function of attaching multiple pieces together. Simply substituting one attachment means for another would yield the predicable result of allowing the catheter and valve to attach and reattach by snap and release. See MPEP 2143.
Regarding Claim 6, Cohen in view of Fischell, Meadows, Kick and Sakaguchi teaches a uniform internal diameter drainage device as set forth in claim 5. Cohen fails to teach wherein said flush port is a spring loaded flush port and receives an external saline source for flushing said drainage device. Fischell further teaches wherein said flush port (flush tube, 636) is a spring loaded flush port (paragraph [0296]) and receives an external saline source for flushing said drainage device (paragraph [0297]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter of Cohen in view of Fischell, Kick and Sakaguchi to include a flush port is a spring loaded flush port and receives an external saline source for flushing said drainage device similar to that disclosed by Fischell to ensure that the tube remains clean and unclogged for drainage and continued use (as motivated by Fischell, paragraph [0297]).
Regarding Claim 13, Cohen in view of Fischell, Meadows, Kick and Sakaguchi teaches a uniform internal diameter drainage device as set forth in claim 14. Cohen further teaches: said receiving port (valve mechanism, 52) of said first end of said drainage device (figure 3) comprises an externally annular attachment mechanism (annular collars 54, 56), an internal annular recess (84) and an annular shoulder (54);
said engaging port (78) of said second end (54) comprises a chamfered connection surface on its distal end engaging said annular shoulder (figure 3), and an annular ring (Column 6, lines 8-10: Diaphragm 88 is preferably a ring-shaped member sized to provided sealing contact with valve passage 52 and tubular portion 82) said annular recess (84) to form said fluid-tight connection (column 6, lines 8-10) engaging said annular recess to form said fluid-tight connection (column 6, lines 8-10).
Cohen fails to teach wherein the attachment mechanism is snap and release. In the same field of endeavor, namely catheter hubs, Sakaguchi teaches a catheter hub wherein the attachment mechanism is snap and release (claim 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the attachment mechanism of Cohen that allows the catheter and valve to connect and disconnect, for the snap and release mechanism of Sakaguchi since these mechanisms perform the same function of attaching multiple pieces together. Simply substituting one attachment means for another would yield the predicable result of allowing the catheter and valve to attach and reattach by snap and release. See MPEP 2143.
Regarding Claim 14, Cohen in view of Fischell, Meadows, Kick and Sakaguchi teaches a uniform internal diameter drainage device as set forth in claim 13. Cohen fails to teach wherein said flush port is a spring loaded flush port and receives an external saline source for flushing said drainage device. Fischell further teaches wherein said flush port (flush tube, 636) is a spring loaded flush port (paragraph [0296]) and receives an external saline source for flushing said drainage device (paragraph [0297]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter of Cohen in view of Fischell to include a flush port is a spring loaded flush port and receives an external saline source for flushing said drainage device similar to that disclosed by Fischell to ensure that the tube remains clean and unclogged for drainage and continued use (as motivated by Fischell, paragraph [0297]).
Claim(s) 7-10 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (US 6162201 A) in view of Fischell (US 20140358079 A1) in view of Meadows (US 20200306141 A1) in view of Kick (US 20060135962 A1) in view of Sakaguchi (US 11331450 B2) as applied to claim 6 and 14 above, and further in view of Rosenberg (US 4600402 A).
Regarding Claim 7, Cohen in view of Fischell, Meadows, Kick and Sakaguchi teaches a uniform internal diameter drainage device as set forth in claim 6. Cohen in view of Fischell, Kick and Sakaguchi fails to teach wherein said drainage receptacle is selected from a drainage bag , an accordion suction and a suction bulb. In the same field of endeavor, namely drainage catheters, Rosenberg teaches catheter (38), the connector (74) is connected to an upstream end of a drainage tube which leads to a drainage bag (column 4, lines 6-10), and urine drains through the catheter (38) and drainage tube to the bag for retention therein (Column 4, lines 6-10). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter system of Cohen in view of Fischell, Kick and Sakaguchi to include a drainage bag similar to that disclosed by Rosenberg so that the urine may be collected and tested.
Regarding Claim 8, Cohen in view of Fischell, Meadows, Kick, Sakaguchi and Rosenberg teaches a uniform internal diameter drainage device as set forth in claim 7. Cohen and Fischell fail to teach wherein said apertures of said catheter are of substantially uniform size and shape. Kick teaches wherein said apertures of said catheter are of substantially uniform size and shape (drainage holes or ports 1006) (paragraph [0086]) (figures 17C). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the drainage apertures of Cohen in view of Fischell and Kick so the apertures are a similar size and shape similar to that disclosed by Kick so that the flow into the catheter is uniform so it can be precisely calculated and controlled.
Regarding Claim 9, Cohen in view of Fischell, Meadows, Kick, Sakaguchi and Rosenberg teaches the uniform internal diameter drainage device as set forth in Claim 8. Cohen fails to teach wherein said flush port comprises an internal diameter substantially uniform said internal diameter of the multi-directional hub from said first end and to said second end. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have make the flush port shown in Fischell have an equal diameter to the catheter of Cohen since this claimed dimension of the flush does not change its ability to clean the catheter. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 0011 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding Claim 10, Cohen in view of Fischell, Meadows, Kick, Sakaguchi and Rosenberg teaches the uniform internal diameter drainage device as set forth in Claim 9. Cohen fails to teach wherein said flush port comprises an internal diameter different than said internal diameter of said first end and said second end. Fischell teaches wherein said flush port comprises an internal diameter different than said internal diameter of said first end and said second end (paragraph [0296]) (figure 33: flush tube 636 is significantly smaller than the catheter). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Cohen in view of Fischell to include flush port comprises an internal diameter different than said internal diameter of said first end and said second end similar to that disclosed by Fish cell so that the saline volume is not larger than the catheter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have make the flush port shown in Fischell have an different diameter to the catheter of Cohen since this claimed dimension of the flush does not change its ability to clean the catheter. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 0011 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding Claim 15, Cohen in view of Fischell, Meadows, Kick, Sakaguchi and Rosenberg teaches a uniform internal diameter drainage device as set forth in claim 14. Cohen fails to teach wherein said drainage receptacle is selected from a drainage bag , an accordion suction and a suction bulb. In the same field of endeavor, namely drainage catheters, Rosenberg teaches catheter (38), the connector (74) is connected to an upstream end of a drainage tube which leads to a drainage bag (column 4, lines 6-10), and urine drains through the catheter (38) and drainage tube to the bag for retention therein (Column 4, lines 6-10). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter system of Cohen in view of Fischell to include a drainage bag similar to that disclosed by Rosenberg so that the urine may be collected and tested.
Regarding Claim 16, Cohen in view of Fischell, Meadows, Kick, Sakaguchi and Rosenberg teaches the uniform internal diameter drainage device as set forth in Claim 15. Cohen fails to teach wherein said flush port comprises an internal diameter substantially uniform said internal diameter of said first end and said second end. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have make the flush port shown in Fischell have an equal diameter to the catheter of Cohen since this claimed dimension of the flush does not change its ability to clean the catheter. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 0011 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding Claim 17, Cohen in view of Fischell, Meadows, Kick, Sakaguchi and Rosenberg teaches the uniform internal diameter drainage device as set forth in Claim 16. Cohen fails to teach wherein said flush port comprises an internal diameter different than said internal diameter of said first end and said second end. Fischell teaches wherein said flush port comprises an internal diameter different than said internal diameter of said first end and said second end (paragraph [0296]) (figure 33: flush tube 636 is significantly smaller than the catheter). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Cohen in view of Fischell to include flush port comprises an internal diameter different than said internal diameter of said first end and said second end similar to that disclosed by Fischell so that the saline volume is not larger than the catheter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have make the flush port shown in Fischell have a different diameter to the catheter of Cohen since this claimed dimension of the flush does not change its ability to clean the catheter. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 0011 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
Prosecution Insights