DETAILED ACTION
In view of the appeal brief filed on 06/25/2026, PROSECUTION IS HEREBY REOPENED. A new grounds of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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 .
In light of the amendments to the claims filed 11/19/2025 in which claims 58, 85, and 108 were amended and claims 90-94 and 100-104 were cancelled, claims 58-61 and 64-89, 95-99, and 105-108 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/DK2019/050363 which claims priority to DKPA/2018/00892 filed on 11/21/2018.
Claims 58-61 and 64-89, 95-99, and 105-108 receive priority to the prior-filed application, filed on 11/21/2018.
Response to Arguments
Claim Objections
The objections to the claims have been withdrawn in view of the amendments filed 06/25/2026 wherein the claim identifiers were updated.
Claim Rejections under 35 U.S.C. 103
Applicant’s arguments filed 06/25/2026, with respect to the burden and requirements of inherency have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nyman, Carlsson, and Buydenok, as explained below.
Applicant's arguments filed 06/25/2026, with respect to the arguments against optimization and the disclosures of Carlsson regarding the size of the drainage openings have been fully considered but they are not persuasive.
The applicant asserts throughout the appeal brief filed 06/25/2026 that Carlsson fails to disclose a diameter of the drainage holes, that Carlsson warns against kinking and one of ordinary skill reading Carlsson would not select more, smaller holes as Carlsson teaches that this leads to kinking, and that Carlsson teaches away from decreasing the size of the holes or increasing the amount of holes to keep the open hole area larger than the lumen area (pg. 31-35 and 38-40).
In response to the applicant’s arguments, the examiner respectfully disagrees. As cited in the previous Office Action filed 03/09/2026, Carlsson (pg. 11 ln. 7-9) discloses drainage openings having a diameter between 0.75-2 mm, which overlaps the range claimed in claim 58. Carlsson does caution against kinking in a catheter (pg. 3 ln. 6-8); however, Carlsson (pg. 5 ln. 17-19) discloses that “Smaller drainage holes are advantageous in terms of that the decreased size of the holes also results in that the risk for kinking is also decreased.” Carlsson (pg. 5 ln. 25-28) further discloses that “…a larger amount of smaller holes are preferred over a smaller amount of large holes (provided that the combined area of the smaller holes is larger or equal to that of the large holes).” Carlsson also discloses maintaining a total hole area that is equal to or larger than the circular area of the catheter lumen to ensure that the catheter performs the same or greater flow rate than large holes (conventional oval catheter eyes) (pg. 5 ln. 23-28; pg. 10 ln. 30-33 and pg. 11 ln. 1-6). As Carlsson discloses that the total number of pairs of holes can be any suitable number dependent upon the intended application and particular needs of a catheter (pg. 18 ln. 13-16) and that Carlsson prefers more, smaller holes to decrease the risk of kinking, one of ordinary skill in the art when reading the disclosures of Carlsson would understand that as the total number of holes increase, the size of the holes would need to be adjusted to maintain the total hole area at least equal to the circular area of the catheter lumen.
Applicant’s substantive arguments related to the claims at issue have been addressed in the instant rejection.
In response to the applicant’s allegations of impermissible bias on pg. 44-47, a review of all of the Office Actions reveals that the examiner did comply with all applicable rules and procedures, which were properly reviewed and signed, including by the SPE when necessary, in accordance with MPEP 1004. There is no evidence in the record that indicates any bias on the part of the examiners or SPE. The prosecution history does not show the examiners or SPE have acted in an arbitrary and capricious manner in the performance of their duties but performed the duties of their oath of office in accordance with the applicable Federal statutes and regulations and USPTO policy. There is no evidence that the examiners or SPE have taken an arbitrary and capricious position but have acted properly within the scope of their authority.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 58-61, 81-84, 95-97, and 105 are rejected under 35 U.S.C. 103 as being unpatentable over US/2016/0184551 A1 to Nyman, in view of WO/2017/108879 A1 to Carlsson.
Regarding claims 58, 81, and 105, Nyman discloses a catheter (Fig. 1) comprising:
an intermittent urinary catheter (para. 0017; para. 0067; Fig. 1, catheter 1) having a tubular portion extending from a proximal insertion end to a distal outlet end (para. 0017-0018; para. 0070, insertable length coated with hydrophilic material; para. 0081, hydrophilic coating on tubular portion 3 and tip 5; Fig. 1, tubular portion 3 extending from tip 5 at proximal insertion end to handle 2 at distal outlet end), with the proximal insertion end insertable into a bladder to drain urine (para. 0002; para. 0016; para. 0023; para. 0056; para. 0074) and the tubular portion formed to include a lumen adapted to transport the urine through the tubular portion and out of the distal outlet end (para. 0002; para. 0016; para. 0023; para. 0056; para. 0074); and
a drainage area provided on an exterior surface of the tubular portion immediately distal the proximal insertion end (para. 0023; para. 0068-0069, one or more drainage apertures 4; para. 0074; Fig. 1, drainage area comprising total area of drainage aperture[s] 4),
wherein the drainage area includes a plurality of drainage openings that combine to provide an open drain area; wherein the drainage area is defined by a length measured from a proximal edge of a proximal most one of the plurality of the drainage openings that is closest to the proximal insertion end to a distal edge of a distal most one of the plurality of the drainage openings that is closest to the distal outlet end multiplied by a circumference of the exterior surface of the tubular portion measured along the length of the drainage area (para. 0023; para. 0068-0069, one or more drainage apertures 4; para. 0074; Fig. 1, drainage area comprising total area of drainage aperture[s] 4; multiple apertures not shown).
Nyman differs from the instantly claimed invention in that Nyman fails to disclose
(Claim 58) wherein the plurality of drainage openings comprises multiple small openings having a hole diameter in a range between 0.2-1.0 mm;
(Claim 81) wherein a measured suction pressure in the lumen is less than 50 Mbar when the distal most one of the plurality of the drainage openings is immersed under 10 cm H2O; and
(Claim 105) wherein a number of the plurality of drainage openings is selected to configure the open drain area to be larger than a cross-sectional area of the lumen.
PNG
media_image1.png
346
722
media_image1.png
Greyscale
Ex. Fig. 1 of Carlsson Fig. 5A
Carlsson teaches
(Claim 58) a generalized catheter (pg. 1 ln. 29-31 and pg. 2 ln. 1-16; Fig. 5A) comprising:
a urinary catheter (pg. 1 ln. 3-6; Fig. 5A, catheter 2) having a tubular portion extending from a proximal insertion end to a distal outlet end (see Ex. Fig. 1, tubular portion extending proximal insertion end 5 to distal outlet end 4; pg. 1 ln. 23-27), with the proximal insertion end insertable into a bladder to drain urine (pg. 1 ln. 9-28) and the tubular portion formed to include a lumen adapted to transport the urine through the tubular portion and out of the distal outlet end (pg. 1 ln. 9-28; pg. 18 ln. 9-11); and
a drainage area provided on an exterior surface of the tubular portion immediately distal the proximal insertion end (see Ex. Fig. 1 showing drainage area on the exterior surface of the tubular portion immediately distal proximal insertion end 5),
wherein the drainage area includes a plurality of drainage openings that combine to provide an open drain area (see Ex. Fig. 1 showing drainage area including drainage openings 17a-c providing an open drain area); wherein the drainage area is defined by a length measured from a proximal edge of a proximal most one of the plurality of the drainage openings that is closest to the proximal insertion end to a distal edge of a distal most one of the plurality of the drainage openings that is closest to the distal outlet end multiplied by a circumference of the exterior surface of the tubular portion measured along the length of the drainage area (see Ex. Fig. 1 showing the drainage area having a length from a proximal most to distal most drainage opening; Fig. 5d showing catheter 2 comprising a circumference),
wherein the plurality of drainage openings comprises multiple small openings having a hole diameter in a range between 0.75 to 2.0 mm (pg. 11 ln. 7-9); and
(Claim 105) wherein a number of the plurality of drainage openings is selected to configure the open drain area to be larger than a cross-sectional area of the lumen (pg. 5 ln. 23-28; pg. 10 ln. 32-33 and pg. 11 ln. 1-6).
While Carlsson fails to explicitly disclose that a largest dimension of the plurality of drainage openings is in a range between 0.2 mm to 1 mm, Carlsson discloses that the number and size of the drainage openings may be optimized to decrease the risk for kinking in the catheter shaft and increase ease of control over the initial flow rate into the catheter (pg. 5 ln. 15-33 and pg. 6 ln. 1-6), while maintaining a total hole area such that “the total hole area…is equal to or larger than the circular area of the catheter lumen [such that the openings] will perform the same or greater flow rate than conventional oval catheter eyes with a total hole area that is significantly larger than the circular area of the catheter lumen” (pg. 5 ln. 23-28; pg. 10 ln. 30-33 and pg. 11 ln. 1-6). Carlsson further discloses that dependent upon the intended application and particular needs of the catheter, the number of pairs of drainage openings can be any suitable number (pg. 18 ln. 13-16); therefore, for any specific size of catheter, as the total number of pairs of drainage openings increase, the size of the drainage openings would need to be adjusted to maintain the total hole area at least equal to the circular area of the catheter lumen.
It appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Nyman, in view of Carlsson, to have drainage openings within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Nyman, in view of Carlsson, by making the largest dimension of any one of the plurality of openings between 0.2-1 mm as a matter of routine optimization 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." See MPEP 2144.05.
Regarding the limitation (Claim 58) “wherein the multiple small openings provide resistance to the urine entering the open drain area that distributes a flow of the urine across the drainage area to eliminate clogging of the openings and ensure complete emptying of the bladder” as that the invention of Nyman, in view of Carlsson, suggests multiple small openings comprising diameters which at least overlap the claimed range, it follows naturally that this result would occur. The Poiseuille equation relates resistance (R) to length of a tube (L), viscosity of a fluid passing through the tube (η), and the radius of the tube (r):
R
=
8
η
L
(
π
r
4
)
. Assuming that the length (thickness of the catheter wall through which the openings pass) and viscosity of the urine remain constant, decreasing the radius of the openings increases the resistance to flow through the openings. The Applicant’s Specification discloses (pg. 9 ln. 14-18) that “…the resistance due to viscous friction is markedly higher in the intermittent urinary catheter with small drainage openings - and thereby, the more proximal drainage openings are "forced" to contribute to a larger extent to give a more even distribution of flow and pressure across the external surface of the catheter as well as in a distance close to the catheter,” and (pg. 31 ln. 1-3) “no clogging occurs in an intermittent urinary catheter with multiple small drainage openings…flow may be reduced…but will continue by itself until the bladder is empty.” Therefore, the invention of Nyman, in view of Carlsson, as comprising an intermittent urinary catheter with small drainage openings reads on the limitation as claimed.
Further, the limitations drawn to the resistance provided by the number and spacing of holes are considered to be functional language. If a prior art structure is capable of performing the function as recited in the claim, the prior art structure is considered to reasonably meet the limitations of the claim. In the instant case, the combination of Nyman and Carlsson suggests all of the structure as claimed by Applicant and as explained above, is capable of providing the resistance claimed by Applicant. See MPEP 2112.01(I).
Regarding the limitation (Claim 81) “wherein a measured suction pressure in the lumen is less than 50 Mbar when the distal most one of the plurality of the drainage openings is immersed under 10 cm H2O” as that the invention of Nyman, in view of Carlsson, suggests multiple small openings comprising diameters which at least overlap the claimed range, it follows naturally that this result would occur in the overlapped range. The Applicant’s Specification discloses (pg. 17 ln. 3-13) that “…the largest dimension of an individual drainage opening in an outer convex surface of the tubular portion is less than 1 mm…each of the drainage openings has a cross-sectional area of less than 0.8
m
m
2
. Thereby, it is secured that a negative pressure no larger than 50 mBar when measured under 10 cm H2O can occur…” Therefore, the invention of Nyman, in view of Carlsson, as suggesting an intermittent urinary catheter with small drainage openings reads on the limitation as claimed at least in the overlapped range.
Regarding claim 59-61, the cited prior art suggests the invention of claim 58; however, the cited prior art differs from the instantly claimed invention in that Carlsson fails to explicitly disclose wherein the ratio of the open drain area to the drainage area on the exterior surface of the tubular portion is in a range from (Claim 59) 0.2 to 0.5 and (Claim 60) 0.51 to 0.7, or wherein there is (Claim 61) more open area than closed area on the drainage area on the exterior surface of the tubular portion.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Nyman, as modified by Carlsson, to have a ratio of the open drain area to the drainage area on the exterior surface of the tubular portion is in a range from (Claim 59) 0.2 to 0.5 and (Claim 60) 0.51 to 0.7, or wherein there is (Claim 61) more open area than closed area on the drainage area on the exterior surface of the tubular portion since it has been 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” See MPEP 2144.04. In the instant case, the device of Nyman would not operate differently with the claimed ratio as the size and number of apertures can be modified along the drainage area based on the disclosures of Carlsson and since the device of Nyman, as modified by Carlsson comprises a plurality of drainage openings, the device would function appropriately as a drainage catheter having the claimed ratio. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the ratio is within the range (specification pg. 16 ln. 9-15).
Regarding claim 82, the cited prior art suggests the invention of claim 58. Nyman further discloses: wherein the proximal insertion end comprises a closed end (para. 0073-0075; Fig. 4A-4C showing tip 5 as a closed end).
Regarding claim 83, the cited prior art suggests the invention of claim 58. Nyman further discloses: wherein the distal outlet end comprises a handle (para. 0017-0018; para. 0070, insertable length coated with hydrophilic material; para. 0081, hydrophilic coating on tubular portion 3 and tip 5; Fig. 1, tubular portion 3 extending from tip 5 at proximal insertion end to handle 2 at distal outlet end).
Regarding claim 84, the cited prior art suggests the invention of claim 58. Nyman further discloses: wherein the intermittent urinary catheter comprises a hydrophilic coating that is lubricious when wetted by water (para. 0017-0018; para. 0070, insertable length coated with hydrophilic material; para. 0081, hydrophilic coating on tubular portion 3 and tip 5; Fig. 1, tubular portion 3 extending from tip 5 at proximal insertion end to handle 2 at distal outlet end).
Regarding claim 95, the cited prior art suggests the invention of claim 58.
Regarding the limitation “wherein the ratio of the open drain area to the drainage area on the exterior surface of the tubular portion configures the intermittent urinary catheter for a continuous and uninterrupted flow of urine until the bladder is empty” as that the invention of Nyman, in view of Carlsson, suggests multiple small openings distributed along the drain length, it follows naturally that this result would occur. The Poiseuille equation relates resistance (R) to length of a tube (L), viscosity of a fluid passing through the tube (η), and the radius of the tube (r):
R
=
8
η
L
(
π
r
4
)
. Assuming that the length (thickness of the catheter wall through which the openings pass) and viscosity of the urine remain constant, decreasing the radius of the openings increases the resistance to flow through the openings. The Applicant’s Specification discloses (pg. 9 ln. 14-18) that “…the resistance due to viscous friction is markedly higher in the intermittent urinary catheter with small drainage openings - and thereby, the more proximal drainage openings are "forced" to contribute to a larger extent to give a more even distribution of flow and pressure across the external surface of the catheter as well as in a distance close to the catheter,” (pg. 5 ln. 14-16) “[e]nsuring that the urine inflow to the catheter is distributed as much as possible along the surface inserted into the bladder lowers the risk of clogging and by that residual urine together with discomfort due to abruption of flow”, and (pg. 31 ln. 1-3) “no clogging occurs in an intermittent urinary catheter with multiple small drainage openings…flow may be reduced…but will continue by itself until the bladder is empty.” Therefore, the invention of Nyman, in view of Carlsson, as comprising an intermittent urinary catheter with small drainage openings reads on the limitation as claimed.
Further, the limitations drawn to the results provided by the number and spacing of holes along the catheter are considered to be functional language. If a prior art structure is capable of performing the function as recited in the claim, the prior art structure is considered to reasonably meet the limitations of the claim. In the instant case, the combination of Nyman and Carlsson suggests all of the structure as claimed by Applicant and as explained above, is capable of providing the results claimed by Applicant. See MPEP 2112.01(I).
Regarding claim 96, the cited prior art suggests the invention of claim 58.
Regarding the limitation “wherein the ratio of the open drain area to the drainage area on the exterior surface of the tubular portion configures the intermittent urinary catheter for a continuous and uninterrupted flow of urine from a bladder without repositioning of the tubular portion of the intermittent urinary catheter” as that the invention of Nyman, in view of Carlsson, suggests multiple small openings distributed along the drain length, it follows naturally that this result would occur. The Poiseuille equation relates resistance (R) to length of a tube (L), viscosity of a fluid passing through the tube (η), and the radius of the tube (r):
R
=
8
η
L
(
π
r
4
)
. Assuming that the length (thickness of the catheter wall through which the openings pass) and viscosity of the urine remain constant, decreasing the radius of the openings increases the resistance to flow through the openings. The Applicant’s Specification discloses (pg. 9 ln. 14-18) that “…the resistance due to viscous friction is markedly higher in the intermittent urinary catheter with small drainage openings - and thereby, the more proximal drainage openings are "forced" to contribute to a larger extent to give a more even distribution of flow and pressure across the external surface of the catheter as well as in a distance close to the catheter,” (pg. 5 ln. 14-16) “[e]nsuring that the urine inflow to the catheter is distributed as much as possible along the surface inserted into the bladder lowers the risk of clogging and by that residual urine together with discomfort due to abruption of flow”, and (pg. 31 ln. 1-3) “no clogging occurs in an intermittent urinary catheter with multiple small drainage openings…flow may be reduced…but will continue by itself until the bladder is empty.” Therefore, the invention of Nyman, in view of Carlsson, as comprising an intermittent urinary catheter with small drainage openings reads on the limitation as claimed.
Further, the limitations drawn to the results provided by the number and spacing of holes along the catheter are considered to be functional language. If a prior art structure is capable of performing the function as recited in the claim, the prior art structure is considered to reasonably meet the limitations of the claim. In the instant case, the combination of Nyman and Carlsson suggests all of the structure as claimed by Applicant and as explained above, is capable of providing the results claimed by Applicant. See MPEP 2112.01(I).
Regarding claim 97, the cited prior art suggests the invention of claim 58.
Regarding the limitation “wherein the ratio of the open drain area to the drainage area on the exterior surface of the tubular portion configures the intermittent urinary catheter for a flow of urine from a bladder that reduces or eliminates residual urine remaining in the bladder” as that the invention of Nyman, in view of Carlsson, suggests multiple small openings distributed along the drain length, it follows naturally that this result would occur. The Poiseuille equation relates resistance (R) to length of a tube (L), viscosity of a fluid passing through the tube (η), and the radius of the tube (r):
R
=
8
η
L
(
π
r
4
)
. Assuming that the length (thickness of the catheter wall through which the openings pass) and viscosity of the urine remain constant, decreasing the radius of the openings increases the resistance to flow through the openings. The Applicant’s Specification discloses (pg. 9 ln. 14-18) that “…the resistance due to viscous friction is markedly higher in the intermittent urinary catheter with small drainage openings - and thereby, the more proximal drainage openings are "forced" to contribute to a larger extent to give a more even distribution of flow and pressure across the external surface of the catheter as well as in a distance close to the catheter,” (pg. 5 ln. 14-16) “[e]nsuring that the urine inflow to the catheter is distributed as much as possible along the surface inserted into the bladder lowers the risk of clogging and by that residual urine together with discomfort due to abruption of flow”, and (pg. 31 ln. 1-3) “no clogging occurs in an intermittent urinary catheter with multiple small drainage openings…flow may be reduced…but will continue by itself until the bladder is empty.” Therefore, the invention of Nyman, in view of Carlsson, as comprising an intermittent urinary catheter with small drainage openings reads on the limitation as claimed.
Further, the limitations drawn to the results provided by the number and spacing of holes along the catheter are considered to be functional language. If a prior art structure is capable of performing the function as recited in the claim, the prior art structure is considered to reasonably meet the limitations of the claim. In the instant case, the combination of Nyman and Carlsson suggests all of the structure as claimed by Applicant and as explained above, is capable of providing the results claimed by Applicant. See MPEP 2112.01(I).
Claims 64-80 are rejected under 35 U.S.C. 103 as being unpatentable over Nyman and Carlsson as applied above, and further in view of US/2013/0085468 A1 to Buydenok.
Regarding claims 64-80, the cited prior art suggests the invention of claim 58. The cited prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose wherein
(Claim 64) each of the plurality of drainage openings has an open area of about 0.44 mm2, and the intermittent urinary catheter comprises more than 12 drainage openings;
(Claim 65) the largest dimension of any one of the plurality of drainage openings is about 0.2 mm, and the intermittent urinary catheter comprises about 128 drainage openings;
(Claim 66) the largest dimension of any one of the plurality of drainage openings is about 0.4 mm, and the intermittent urinary catheter comprises about 32 drainage openings;
(Claim 67) the largest dimension of any one of the plurality of drainage openings is about 0.6 mm, and the intermittent urinary catheter comprises about 15 drainage openings;
(Claim 68) the largest dimension of any one of the plurality of drainage openings is about 0.7 mm, and the intermittent urinary catheter comprises about 11 drainage openings;
(Claim 69) the largest dimension of any one of the plurality of drainage openings is about 0.2 mm, and the intermittent urinary catheter comprises about 176 drainage openings;
(Claim 70) the largest dimension of any one of the plurality of drainage openings is about 0.4 mm, and the intermittent urinary catheter comprises about 44 drainage openings;
(Claim 71) the largest dimension of any one of the plurality of drainage openings is about 0.6 mm, and the intermittent urinary catheter comprises about 20 drainage openings;
(Claim 72) the largest dimension of any one of the plurality of drainage openings is about 0.7 mm, and the intermittent urinary catheter comprises about 15 drainage openings;
(Claim 73) the largest dimension of any one of the plurality of drainage openings is about 0.2 mm, and the intermittent urinary catheter comprises about 261 drainage openings;
(Claim 74) the largest dimension of any one of the plurality of drainage openings is about 0.4 mm, and the intermittent urinary catheter comprises about 66 drainage openings;
(Claim 75) the largest dimension of any one of the plurality of drainage openings is about 0.6 mm, and the intermittent urinary catheter comprises about 29 drainage openings;
(Claim 76) the largest dimension of any one of the plurality of drainage openings is about 0.7 mm, and the intermittent urinary catheter comprises about 22 drainage openings;
(Claim 77) the largest dimension of any one of the plurality of drainage openings is about 0.2 mm, and the intermittent urinary catheter comprises about 351 drainage openings;
(Claim 78) the largest dimension of any one of the plurality of drainage openings is about 0.4 mm, and the intermittent urinary catheter comprises about 88 drainage openings;
(Claim 79) the largest dimension of any one of the plurality of drainage openings is about 0.6 mm, and the intermittent urinary catheter comprises about 39 drainage openings;
(Claim 80) the largest dimension of any one of the plurality of drainage openings is about 0.7 mm, and the intermittent urinary catheter comprises about 29 drainage openings.
Buydenok further discloses a generalized catheter (para. 0039; Fig. 2) comprising:
a urinary catheter (para. 0039; Fig. 2, catheter) having a tubular portion extending from a proximal insertion end to a distal outlet end (Fig. 1, catheter comprising tubular portion 102 extending from proximal insertion end 104 to distal outlet end 101), with the tubular portion formed to include a lumen adapted to transport liquid through the urinary catheter (para. 0025); and
a drainage length provided on an exterior surface of the tubular portion, wherein the drainage length includes a plurality of drainage openings that combine to provide an open drain area configured to drain liquid from a body cavity (para. 0025; Fig. 2 showing the drainage area having a length from a proximal most to a distal most of the drainage openings 105a-n).
Buydenok teaches that one skilled in the art would appreciate that the number and size of the openings may be selected to achieve a desired level of flow into and/or out of the lumen of the catheter (para. 0029).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to reach the size and number of drainage openings as claimed and modify Nyman to comprise these, because Carlsson teaches that a larger number of smaller holes decreases the risk for kinking in a catheter and increases control over the initial flow rate (pg. 5 ln. 15-33 and pg. 6 ln. 1-6) and Buydenok teaches that it’s known to modify the number and size of the holes in a catheter based on a desired level of flow (para. 0029).
Claims 85-89, 98-99, and 107-108 are rejected under 35 U.S.C. 103 as being unpatentable over US/2016/0184551 A1 to Nyman, in view of WO/2017/108879 A1 to Carlsson and US/2013/0085468 A1 to Buydenok.
Regarding claims 85 and 98-99, Nyman discloses
(Claim 85) a catheter (Fig. 1) comprising:
an intermittent urinary catheter (para. 0017; para. 0067; Fig. 1, catheter 1) having a tubular portion extending from a proximal insertion end to a distal outlet end (para. 0017-0018; para. 0070, insertable length coated with hydrophilic material; para. 0081, hydrophilic coating on tubular portion 3 and tip 5; Fig. 1, tubular portion 3 extending from tip 5 to handle 2), with the proximal insertion end insertable into a bladder to drain urine (para. 0002; para. 0016; para. 0023; para. 0056; para. 0074), with the tubular portion formed to include a lumen adapted to transport the urine through the intermittent urinary catheter (para. 0002; para. 0016; para. 0023; para. 0056; para. 0074); and
a drain length provided on an exterior surface of the tubular portion, wherein the drain length is sized for positioning within a bladder and includes a plurality of drainage openings that combine to provide an open drain area configured to drain the urine from the bladder (para. 0017-0018; para. 0023; para. 0068-0069, one or more drainage apertures 4; para. 0070, insertable length coated with hydrophilic material; para. 0081, hydrophilic coating on tubular portion 3 and tip 5; para. 0074; Fig. 1, drainage area comprising total area of drainage aperture[s] 4);
wherein the drain length is defined by a length measured from a proximal edge of a proximal most one of the plurality of drainage openings that is closest to the proximal insertion end to a distal edge of a distal most one of the plurality of the drainage openings that is closest to the distal outlet end (para. 0023; para. 0068-0069, one or more drainage apertures 4; para. 0074; Fig. 1, drainage area comprising total area of drainage aperture[s] 4; multiple apertures not shown; drain length considered length along catheter 1 comprising multiple apertures).
Nyman differs from the instantly claimed invention in that Nyman fails to disclose
(Claim 85) wherein a largest dimension of any one of the plurality of drainage openings is in a range between 0.2-1.0 mm, and a number of the plurality of drainage openings is in a range from 11 to 351;
(Claim 98) wherein a number of the plurality of drainage openings is selected to configure the open drain area to be larger than a cross-sectional area of the lumen; and
(Claim 99) wherein the plurality of drainage openings includes a plurality of proximal drainage openings and a plurality of distal drainage openings, and at least a size of the plurality of distal drainage openings is selected to increase resistance to flow of the urine into the lumen through at least the plurality of distal drainage openings and distribute the flow of urine into the plurality of proximal drainage openings.
Carlsson teaches
(Claim 85) a generalized catheter (pg. 1 ln. 29-31 and pg. 2 ln. 1-16; Fig. 5A) comprising:
a urinary catheter (pg. 1 ln. 3-6; Fig. 5A, catheter 2) having a tubular portion extending from a proximal insertion end to a distal outlet end (see Ex. Fig. 1, tubular portion extending proximal insertion end 5 to distal outlet end 4; pg. 1 ln. 23-27), with the tubular portion formed to include a lumen adapted to transport urine through the urinary catheter (pg. 1 ln. 21-28; pg. 18 ln. 9-11); and
a drainage length provided on an exterior surface of the tubular portion (see Ex. Fig. 1 showing drainage length on the exterior surface of the tubular portion), wherein the drainage length is sized for positioning within a bladder (pg. 1 ln. 9-28) and includes a plurality of drainage openings that combine to provide an open drain area configured to drain the urine from the bladder (see Ex. Fig. 1 showing drainage area including drainage openings 17a-c; pg. 1 ln. 9-28);
wherein the drainage length is defined by a length measured from a proximal edge of a proximal most one of the plurality of the drainage openings that is closest to the proximal insertion end to a distal edge of a distal most one of the plurality of the drainage openings that is closest to the distal outlet end (see Ex. Fig. 1 showing the drainage area having a length from a proximal most to distal most drainage opening), and
wherein a largest dimension of the plurality of drainage openings is in a range between 0.75 to 2.0 mm (pg. 11 ln. 7-9), and the catheter comprises 6 drainage openings (pg. 18 ln. 13-14);
(Claim 98) wherein a number of the plurality of drainage openings is selected to configure the open drain area to be larger than a cross-sectional area of the lumen (pg. 5 ln. 23-28; pg. 10 ln. 32-33 and pg. 11 ln. 1-6); and
(Claim 99) wherein the plurality of drainage openings includes a plurality of proximal drainage openings and a plurality of distal drainage openings (Fig. 5a showing proximal drainage openings 17a-b and distal drainage openings 17c).
Carlsson teaches that the number and size of the drainage openings may be optimized to decrease the risk for kinking in the catheter shaft and increase ease of control over the initial flow rate into the catheter (pg. 5 ln. 15-33 and pg. 6 ln. 1-6), while maintaining a total hole area such that “the total hole area…is equal to or larger than the circular area of the catheter lumen [such that the openings] will perform the same or greater flow rate than conventional oval catheter eyes with a total hole area that is significantly larger than the circular area of the catheter lumen” (pg. 5 ln. 23-28; pg. 10 ln. 30-33 and pg. 11 ln. 1-6). Carlsson further discloses that dependent upon the intended application and particular needs of the catheter, the number of pairs of drainage openings can be any suitable number (pg. 18 ln. 13-16); therefore, for any specific size of catheter, as the total number of pairs of drainage openings increase, the size of the drainage openings would need to be adjusted to maintain the total hole area at least equal to the circular area of the catheter lumen.
Buydenok further discloses
(Claim 85) a generalized catheter (para. 0039; Fig. 2) comprising:
a urinary catheter (para. 0039; Fig. 2, catheter) having a tubular portion extending from a proximal insertion end to a distal outlet end (Fig. 1, catheter comprising tubular portion 102 extending from proximal insertion end 104 to distal outlet end 101), with the tubular portion formed to include a lumen adapted to transport liquid through the urinary catheter (para. 0025); and
a drainage length provided on an exterior surface of the tubular portion, wherein the drainage length includes a plurality of drainage openings that combine to provide an open drain area configured to drain liquid from a body cavity (para. 0025; Fig. 2 showing the drainage area having a length from a proximal most to a distal most of the drainage openings 105a-n);
wherein the drainage length is defined by a length measured from a proximal edge of a proximal most one of the plurality of the drainage openings that is closest to the proximal insertion end to a distal edge of a distal most one of the plurality of the drainage openings that is closest to the distal outlet end (Fig. 2 showing the drainage area having a length from a proximal most to a distal most of the drainage openings 105a-n).
Buydenok teaches that one skilled in the art would appreciate that the number and size of the openings may be selected to achieve a desired level of flow into and/or out of the lumen of the catheter (para. 0029).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to reach the size and number of drainage openings in the ranges as claimed and modify Nyman to comprise these, because Carlsson teaches that a larger number of smaller holes decreases the risk for kinking in a catheter and increases control over the initial flow rate (pg. 5 ln. 15-33 and pg. 6 ln. 1-6) and Buydenok teaches that it’s known to modify the number and size of the holes in a catheter based on a desired level of flow (para. 0029).
Regarding the limitations (Claim 85) “wherein the plurality of drainage openings is distributed along the drain length to allow complete draining of the urine from the bladder and leave no residual urine in the bladder” and (Claim 99) “at least a size of the plurality of distal drainage openings is selected to increase resistance to flow of urine into the lumen through at least the plurality of distal drainage openings and distribute the flow of urine into the plurality of proximal drainage openings” as that the invention of Nyman, in view of Carlsson and Buydenok, suggests multiple small openings distributed along the drain length, it follows naturally that this result would occur. The Poiseuille equation relates resistance (R) to length of a tube (L), viscosity of a fluid passing through the tube (η), and the radius of the tube (r):
R
=
8
η
L
(
π
r
4
)
. Assuming that the length (thickness of the catheter wall through which the openings pass) and viscosity of the urine remain constant, decreasing the radius of the openings increases the resistance to flow through the openings. The Applicant’s Specification discloses (pg. 9 ln. 14-18) that “…the resistance due to viscous friction is markedly higher in the intermittent urinary catheter with small drainage openings - and thereby, the more proximal drainage openings are "forced" to contribute to a larger extent to give a more even distribution of flow and pressure across the external surface of the catheter as well as in a distance close to the catheter,” (pg. 5 ln. 14-16) “[e]nsuring that the urine inflow to the catheter is distributed as much as possible along the surface inserted into the bladder lowers the risk of clogging and by that residual urine together with discomfort due to abruption of flow”, and (pg. 31 ln. 1-3) “no clogging occurs in an intermittent urinary catheter with multiple small drainage openings…flow may be reduced…but will continue by itself until the bladder is empty.” Therefore, the invention of Nyman, in view of Carlsson and Buydenok, as comprising an intermittent urinary catheter with small drainage openings reads on the limitation as claimed.
Further, the limitations drawn to the resistance and results provided by the number and spacing of holes along the catheter are considered to be functional language. If a prior art structure is capable of performing the function as recited in the claim, the prior art structure is considered to reasonably meet the limitations of the claim. In the instant case, the combination of Nyman, Carlsson, Buydenok suggests all of the structure as claimed by Applicant and as explained above, is capable of providing the resistance claimed by Applicant. See MPEP 2112.01(I).
Regarding claim 86, the cited prior art suggests the invention of claim 85. Nyman further discloses: wherein the proximal insertion end comprises a closed end (para. 0073-0075; Fig. 4A-4C showing tip 5 as a closed end).
Regarding claim 87, the cited prior art suggests the invention of claim 85. Nyman further discloses: wherein the distal outlet end comprises a handle (para. 0017-0018; para. 0070, insertable length coated with hydrophilic material; para. 0081, hydrophilic coating on tubular portion 3 and tip 5; Fig. 1, tubular portion 3 extending from tip 5 at proximal insertion end to handle 2 at distal outlet end).
Regarding claim 88, the cited prior art suggests the invention of claim 85. Nyman further discloses: wherein the intermittent urinary catheter comprises a hydrophilic coating that is lubricious when wetted by water (para. 0017-0018; para. 0070, insertable length coated with hydrophilic material; para. 0081, hydrophilic coating on tubular portion 3 and tip 5; Fig. 1, tubular portion 3 extending from tip 5 at proximal insertion end to handle 2 at distal outlet end).
Regarding claim 89, the cited prior art suggests the invention of claim 85. Nyman further discloses: wherein a drainage area is defined by the drain length multiplied by a circumference of the exterior surface of the tubular portion measured along the drain length (para. 0023; para. 0068-0069, one or more drainage apertures 4; para. 0074; Fig. 1, drainage area comprising total area of drainage aperture[s] 4; multiple apertures not shown); however, the prior art differ from the instantly claimed invention in that the prior art fail to disclose that a ratio of the open drain area to the drainage area on the exterior surface of the tubular portion is in a range from 0.2 to 0.5.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Nyman, as modified by Carlsson and Buydenok, to have a ratio of the open drain area to the drainage area on the exterior surface of the tubular portion in a range from 0.2 to 0.5 since it has been 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” See MPEP 2144.04. In the instant case, the device of Nyman would not operate differently with the claimed ratio as the size and amount of apertures can be modified along the drainage area based on the disclosures of Carlsson and Buydenok and since the device of Nyman, as modified by Carlsson and Buydenok comprises a plurality of drainage openings, the device would function appropriately as a drainage catheter having the claimed ratio. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the ratio is within the range (specification pg. 16 ln. 14-15).
Regarding claim 107, the cited prior art suggests the invention of claim 85.
Regarding the limitation “wherein the plurality of drainage openings allow complete draining of the urine from the bladder to reduce an occurrence of urinary tract infection” as that the invention of Nyman, in view of Carlsson and Buydenok, suggests multiple small openings distributed along the drain length, it follows naturally that this result would occur. The Poiseuille equation relates resistance (R) to length of a tube (L), viscosity of a fluid passing through the tube (η), and the radius of the tube (r):
R
=
8
η
L
(
π
r
4
)
. Assuming that the length (thickness of the catheter wall through which the openings pass) and viscosity of the urine remain constant, decreasing the radius of the openings increases the resistance to flow through the openings. The Applicant’s Specification discloses (pg. 9 ln. 14-18) that “…the resistance due to viscous friction is markedly higher in the intermittent urinary catheter with small drainage openings - and thereby, the more proximal drainage openings are "forced" to contribute to a larger extent to give a more even distribution of flow and pressure across the external surface of the catheter as well as in a distance close to the catheter,” (pg. 5 ln. 14-16) “[e]nsuring that the urine inflow to the catheter is distributed as much as possible along the surface inserted into the bladder lowers the risk of clogging and by that residual urine together with discomfort due to abruption of flow”, and (pg. 31 ln. 1-3) “no clogging occurs in an intermittent urinary catheter with multiple small drainage openings…flow may be reduced…but will continue by itself until the bladder is empty.” Therefore, the invention of Nyman, in view of Carlsson and Buydenok, as comprising an intermittent urinary catheter with small drainage openings reads on the limitation as claimed.
Further, the limitations drawn to the results provided by the number and spacing of holes are considered to be functional language. If a prior art structure is capable of performing the function as recited in the claim, the prior art structure is considered to reasonably meet the limitations of the claim. In the instant case, the combination of Nyman, Carlsson, Buydenok suggests all of the structure as claimed by Applicant and as explained above, is capable of providing the resistance claimed by Applicant. See MPEP 2112.01(I).
Regarding claim 108, the cited prior art suggests the invention of claim 85.
Regarding the limitation “wherein the plurality of drainage openings allow complete draining of the urine from the bladder without repositioning of the drain length of the intermittent urinary catheter within the bladder” as that the invention of Nyman, in view of Carlsson and Buydenok, suggests multiple small openings distributed along the drain length, it follows naturally that this result would occur. The Poiseuille equation relates resistance (R) to length of a tube (L), viscosity of a fluid passing through the tube (η), and the radius of the tube (r):
R
=
8
η
L
(
π
r
4
)
. Assuming that the length (thickness of the catheter wall through which the openings pass) and viscosity of the urine remain constant, decreasing the radius of the openings increases the resistance to flow through the openings. The Applicant’s Specification discloses (pg. 9 ln. 14-18) that “…the resistance due to viscous friction is markedly higher in the intermittent urinary catheter with small drainage openings - and thereby, the more proximal drainage openings are "forced" to contribute to a larger extent to give a more even distribution of flow and pressure across the external surface of the catheter as well as in a distance close to the catheter,” (pg. 5 ln. 14-16) “[e]nsuring that the urine inflow to the catheter is distributed as much as possible along the surface inserted into the bladder lowers the risk of clogging and by that residual urine together with discomfort due to abruption of flow”, and (pg. 31 ln. 1-3) “no clogging occurs in an intermittent urinary catheter with multiple small drainage openings…flow may be reduced…but will continue by itself until the bladder is empty.” Therefore, the invention of Nyman, in view of Carlsson and Buydenok, as comprising an intermittent urinary catheter with small drainage openings reads on the limitation as claimed.
Further, the limitations drawn to the results provided by the number and spacing of holes are considered to be functional language. If a prior art structure is capable of performing the function as recited in the claim, the prior art structure is considered to reasonably meet the limitations of the claim. In the instant case, the combination of Nyman, Carlsson, Buydenok suggests all of the structure as claimed by Applicant and as explained above, is capable of providing the resistance claimed by Applicant. See MPEP 2112.01(I).
Claim 106 is rejected under 35 U.S.C. 103 as being unpatentable over Nyman and Carlsson as applied above, and further in view of US/2011/0282264 A1 to Hurt.
Regarding claim 106, the prior art suggests the invention of claim 58. The prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose wherein a pressure ratio is a difference between a maximum suction pressure measured for the urine entering a first of the multiple small openings and a minimum suction pressure measured for the urine entering a second of the multiple small openings, and wherein the pressure ratio is in a range of 5 to 50.
Hurt teaches a drainage catheter wherein flow is divided more evenly among the flow holes based on differing sizes of the holes along the drainage length of the catheter to reduce the magnitude of flow at any one point (para. 0043-0045; para. 0062; Fig. 1-2, catheter 1 comprising inlet holes 9-13).
The pressure ratio as claimed is directed to a measurement of flow distribution along the drainage length of the catheter. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of Nyman, as modified by Carlsson, to have a lower pressure ratio along the multiple small openings of the catheter as taught by Hurt, because Hurt teaches that distributing flow more evenly among all of the holes provides reduced force at any one point to thereby delay or prevent occlusion of the catheter by the surrounding tissue (para. 0062).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/Linnae E. Raymond/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
