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 .
Response to Amendment
Applicant’s amendments filed on 01/15/2026 has been fully considered. Claims 1-31 are pending in this application. Claims 1, 12, and 23 are amended.
Response to Arguments
The amendment of claim 12 overcomes the 112b rejection of record. The 112b rejection of claim 12 is now withdrawn.
Applicant's arguments filed 01/15/2026, regarding amended independent claims 1 and 23, have been fully considered but they are not persuasive. Regarding the argument that the prior art of Ecklund does not teach the amended independent claims 1 and 23, the argument is unpersuasive. More specifically, the teaching of the embodiment of Figures 10A-10C of Ecklund teaches the aperture that is the outlet 1030 on the top wall 1090A (Paragraph 0154-0156). The rejection of amended independent claims 1 and 23 will further be addressed below.
Though the same prior art reference is re-used herein, amended independent claims 1 and 23 required a change in the grounds of rejection relying on additional prior art teachings as detailed below in the prior art rejection. More specifically, independent claims 1 and 23 now requires an aperture on the top portion of the fluid impermeable barrier, thus further narrowing the scope of the claimed invention. Davis et al. (Publication No. US 2018/0228642 A1) is being introduced as a teaching reference in the new grounds of rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation "an aperture" in line 2. Claim 1 already recites “an aperture” which conflicts with the introduction of another aperture, it is unclear whether instant claim 20 is referring to the same aperture of claim 1 or a different aperture altogether. In an effort to compact prosecution, the limitation is interpreted as the same “an aperture” of claim 1.
Claim 31 recites the limitation "an aperture" in line 6. Claim 23 already recites “an aperture” which conflicts with the introduction of another aperture, it is unclear whether instant claim 20 is referring to the same aperture of claim 1 or a different aperture altogether. In an effort to compact prosecution, the limitation is interpreted as the same “an aperture” of claim 1.
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.
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.
Claim(s) 1-6, 12-16, 19, 21, 23-24, and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Ecklund et al. (Publication No. US 2019/0247222 A1) in view of Cheng et al. (Publication No. US 2004/0006321 A1) and Davis et al. (Publication No. US 2018/0228642 A1).
Regarding claim 1, Ecklund teaches a urine collection device (urine collection device 1600; Figure 16A-16D; Paragraph 0181), comprising:
a fluid impermeable barrier (top wall 1690B and bottom wall 1690A forms the fluid impermeable collection member – walls are made of impermeable material; Figure 16A-16B; Paragraph 0088 and 0183) at least partially defining an opening sized to receive at least a portion of a penis, and a chamber within the fluid collection device in fluid communication with the opening (aperture 1624 to receive the genitalia of the user and a chamber/cavity 1638 is formed within the collection device between the top wall 1690B and bottom wall 1690A; Figure 16A-16D; Paragraph 0183-0184 and 0187), the fluid impermeable barrier having a bottom portion defining the opening (collection member has top wall 1690B/bottom portion that has aperture 1624; Figure 16A-16C; Paragraph 0184), and a top portion opposite to the bottom portion (bottom wall 1690A/top portion on the opposite side; Figure 16A-16C), a proximal end region (proximal end is end opposing to tube 1679; Figure 16A-16C), and a distal end region (distal end portion is portion where tube 1679 is located; Figure 16A-16C; Paragraph 0193-0194), the opening positioned between the proximal end region and the distal end region of the bottom portion of the fluid impermeable barrier (aperture 1624 is between the distal end and proximal end region; Figure 16A-16C);
a fluid permeable body positioned within the chamber between the bottom portion and the top portion of the fluid impermeable barrier, and including a distal portion positioned at least partially in or proximate to the distal end region of the fluid impermeable barrier (distal portion of permeable layer 1690D and outer wicking layer 1690E is at the distal end region of the collection member; Figure 16A-16C), and
a tube extending into the chamber through the opening and having an end positioned proximate to the distal end region of the fluid impermeable barrier (tube 1679 extend into cavity 1638 and has an end that is position next to distal end of the collection member; Figure 16A-16C; Paragraph 0193-0195), wherein the tube includes a tube opening proximate to the end of the tube (tube opening is at tube end for urine drainage; Figure 16A-16C; Paragraph 0193-0195) and at least a portion of the fluid permeable body is positioned between the fluid impermeable barrier and the end of the tube (portion of permeable layer 1690D and outer wicking layer 1690E is between collection member and end of tube 1679; Figure 16A-16C). The embodiment of Figures 16A-16D of Ecklund does not teach an aperture, the chamber within the fluid collection device in fluid communication with the aperture, the top portion defining the aperture.
However, the embodiment of Figures 10A-10C of Ecklund teaches an aperture (outlet 1030 on the top wall 1090A; Paragraph 0154-0156; Figures 10A-10C), the top portion defining the aperture (outlet 1030 on the top wall 1090A; Paragraph 0154-0156; Figures 10A-10C).
Since the prior art of Ecklund recognized the equivalency of having the outlet on the top wall or at the distalmost point (Paragraph 0169) in the field of external urinary catheters, it would have been obvious to a person having ordinary skill in the art to substitute the aperture to be at the top wall instead of the distal most point configuration since it is recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so, with the predictable result of wicking urine away from the genitalia. The simple substitution of one known element for another is obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). The combination of Ecklund further teaches the chamber within the fluid collection device in fluid communication with the aperture (chamber of Figures 16A-16C of Ecklund is in communication with aperture of Figures 10A-10C of Ecklund; see combination above). The combination of Ecklund does not teach a first arm extending from the distal portion of the fluid permeable body towards the proximal end region of the fluid impermeable barrier, and a second arm spaced from the first arm and extending from the distal portion of the fluid permeable body towards the proximal end region of the fluid impermeable barrier.
However, Cheng teaches a first arm extending from the distal portion of the fluid permeable body towards the proximal end region of the fluid impermeable barrier, and a second arm spaced from the first arm and extending from the distal portion of the fluid permeable body towards the proximal end region of the fluid impermeable barrier (y-shaped permeable material 260 has two legs and extend towards the proximal end region from the distal portion; Paragraph 0103 and 0118; Figure 1).
Ecklund and Cheng are both considered to be analogous to the claimed invention because they are in the same field of external urinary catheter. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ecklund to have the to incorporate the teachings of Cheng and have the permeable layer of Ecklund to be Y-shaped, as taught by Cheng. This allows for the wicking material to be shaped for wicking urine away from the male genitalia (Cheng; Paragraph 0103 and 0118).
The combination of Ecklund in view of Cheng does not teach wherein the tube extends outside the chamber from the aperture at least partially towards the proximal end region of the fluid impermeable barrier.
However, Davis teaches wherein the tube extends outside the chamber from the aperture at least partially towards the proximal end region of the fluid impermeable barrier (tube 32 extends out from port 31 is angled towards the proximal end region of the fluid impermeable barrier 40; Figures 27A-27C; Paragraph 0103).
Ecklund in view of Cheng and Davis are both considered to be analogous to the claimed invention because they are in the same field of external urinary catheter. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ecklund in view of Cheng to have the to incorporate the teachings of Davis and have the aperture and tube of Ecklund in view of Cheng be angled to have the tube extend toward the proximal end, as taught by Davis. This allows for the tube to be fixed to a hook when not in use so that the tube does not get pulled out from the device by accident (Davis; Paragraph 0101).
Regarding claim 2, Ecklund in view of Cheng and Davis teaches the device of claim 1. The combination of Ecklund in view of Cheng and Davis further teaches wherein the fluid permeable body includes a continuous substantially planar surface on the first arm, the second arm, and the distal portion (Ecklund; permeable layer 1690D and outer wicking layer 1690E has a continuous planar surface; Figure 16A; Cheng; Y-shaped permeable material has a first arm, second arm, and distal portion; Figure 1; Paragraph 0103 and 0118; see rejection of claim 1 above).
Regarding claim 3, Ecklund in view of Cheng and Davis teaches the device of claim 1. The combination of Ecklund in view of Cheng and Davis further teaches wherein at least the first arm and the second arm of the fluid permeable body include a fluid permeable porous fiber structure and an outer fluid permeable wicking material (Ecklund; permeable layer 1690D and outer wicking layer 1690E; Figure 16A-16C; Paragraph 0188; Cheng; Y-shaped permeable layer with two arms; Figure 1; Paragraph 0103 and 0118), and the distal portion of the fluid permeable body includes at least the fluid permeable porous fiber structure (Cheng; Y-shaped permeable layer with the distal portion; Figure 1; Paragraph 0103 and 0118; Ecklund; fluid permeable material made of permeable layer 1690D and outer wicking layer 1690E; Figure 16A-C; Paragraph 0188).
Regarding claim 4, Ecklund in view of Cheng and Davis teaches the device of claim 1. The combination of Ecklund in view of Cheng and Davis further teaches wherein the distal portion of the fluid permeable body includes the fluid permeable porous fibers and the outer fluid permeable wicking material (Ecklund; permeable layer 1690D and outer wicking layer 1690E; Figure 16A-16C; Paragraph 0188; Cheng; Y-shaped permeable layer with two arms and distal portion; Figure 1; Paragraph 0103 and 0118).
Regarding claim 5, Ecklund in view of Cheng and Davis teaches the device of claim 4. The combination of Ecklund in view of Cheng and Davis further teaches wherein the fluid permeable porous fiber structure includes a substantially uniform thickness in at least the distal portion of the fluid permeable body (Ecklund; permeable layer 1690D and outer wicking layer 1690E has uniform thickness; Figure 16A; Cheng; Y-shaped permeable material has a first arm, second arm, and distal portion; Figure 1; Paragraph 0103 and 0118; see rejection of claim 1 above).
Regarding claim 6, Ecklund in view of Cheng and Davis teaches the device of claim 5. The combination of Ecklund in view of Cheng and Davis further teaches wherein the fluid permeable porous fiber structure includes a substantially uniform thickness in the first arm, the second arm, and the distal portion of the fluid permeable body (Ecklund; permeable layer 1690D and outer wicking layer 1690E has uniform thickness; Figure 16A; Cheng; Y-shaped permeable material has a first arm, second arm, and distal portion; Figure 1; Paragraph 0103 and 0118; see rejection of claim 1 above).
Regarding claim 12, Ecklund in view of Cheng and Davis teaches the device of claim 5. The combination of Ecklund in view of Cheng and Davis further does not teach wherein the distal portion of the fluid permeable body extends less than one-third of a distance between a terminal end of the chamber and the opening.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the distal portion of the fluid permeable body to extend less than one-third of a distance between the terminal end of the chamber and the opening 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the fluid permeable material differently with the claimed distance since the urine collection device is constructed with similar components and structure, and is intended to wick away the urine to the tubing for drainage with the same functionality of collecting urine externally from the user. Further, it appears that the applicant places no criticality on the distance claimed, indicating simply that the distance is “about” be the given ranges (specification; paragraph 0045 and 0067).
Regarding claim 13, Ecklund in view of Cheng and Davis teaches the device of claim 12. The combination of Ecklund in view of Cheng and Davis further teaches the fluid impermeable barrier narrows from the proximal end region to a tip at the distal end region (Ecklund; collection member narrows from the proximal end region to a tip at the distal end region; Figure 16A-16C) and includes a first edge and a second edge extending at least partially between the distal end region and the proximal end region (Ecklund; left and right edge extends between the distal end and proximal end region; Figure 16A-16C);
the first arm is positioned at least proximate to at least a portion of the first edge (first/left arm of Cheng is adjacent to the left edge of the device of Ecklund in view of Cheng and Davis; Figure 1); and
the second arm is positioned at least proximate to at least a portion of the second edge (second/right arm of Cheng is adjacent to the right edge of the device of Ecklund in view of Cheng; Figure 1).
Regarding claim 14, Ecklund in view of Cheng and Davis teaches the device of claim 13. The combination of Ecklund in view of Cheng and Davis does not teach further comprising one or more additional arms extending from the distal portion of the fluid permeable body.
However, since the applicant has not disclosed that having an additional arm extending from the distal portion does anything more than produce predictable results (i.e. provide additional wicking pathways for urine to travel through), the mere duplication of the arm is not considered to have patentable significance. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made, to modify Ecklund in view of Cheng and Davis to have an additional arm between the first and second arm of Ecklund in view of Cheng and Davis, in order to predictably wick urine away from the genitalia of the user. The mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See in re Harza, 124 USPQ 378 (CCPA 1960) (see MPEP § 2144.04).
The combination of Ecklund in view of Cheng and Davis further teaches the one or more additional arms being positioned within the chamber between the first arm and the second arm (see combination above).
Regarding claim 15, Ecklund in view of Cheng and Davis teaches the device of claim 14. The combination of Ecklund in view of Cheng and Davis further teaches wherein each of the one or more additional arms include a fluid permeable porous fiber structure and an outer fluid permeable wicking material (Ecklund; permeable layer 1690D and outer wicking layer 1690E; Figure 16A-16C; Paragraph 0188; Cheng; Y-shaped permeable layer with two arms and third arm from duplication of parts; Figure 1; Paragraph 0103 and 0118).
Regarding claim 16, Ecklund in view of Cheng and Davis teaches the device of claim 14. The combination of Ecklund in view of Cheng and Davis further teaches wherein each of the one or more additional arms is substantially planar (Ecklund; permeable layer 1690D and outer wicking layer 1690E has a continuous planar surface; Figure 16A; Cheng; Y-shaped permeable material has a first arm, second arm, and distal portion and third arm from duplication of parts; Figure 1; Paragraph 0103 and 0118; see rejection of claim 1 above).
Regarding claim 19, Ecklund in view of Cheng and Davis teaches the device of claim 12. The combination of Ecklund in view of Cheng and Davis further teaches wherein the first arm, the second arm, and the distal portion of the fluid permeable body form a Y-shaped configuration (Cheng; Y-shaped fluid permeable body; Figure 1).
Regarding claim 21, Ecklund in view of Cheng and Davis teaches the device of claim 1. The combination of Ecklund in view of Cheng and Davis further teaches wherein the distal portion of fluid permeable body covers the tube opening (distal portion of Y-shaped fluid permeable material covers tube opening and extends past tube opening; Cheng – Figure 1; Ecklund; Figure 16A-16C).
Regarding claim 23, Ecklund teaches a method of collecting urine (collecting urine with urine collection device 1600; Figure 16A-D; Paragraph 0181; Abstract), the method comprising:
inserting a penis through an opening in a bottom portion of a fluid impermeable barrier of a urine collection device into a chamber of the urine collection device at least partially defined by the fluid impermeable barrier (aperture 1624 to receive the genitalia of the user formed on bottom wall 1690A of the collection member and into a chamber/cavity 1638 is formed within the collection device between the top wall 1690B and bottom wall 1690A; Figure 16A-16D; Paragraph 0183-0184 and 0187), the opening being spaced between a proximal end region and a distal end region of the bottom portion of the fluid impermeable barrier (aperture 1624 is between the distal end and proximal end region; Figure 16A-16C);
drawing urine discharged by the penis in the chamber through a fluid permeable body (permeable layer 1690D and outer wicking layer 1690E is the fluid permeable body within the cavity 1638 to wick urine through and towards the tube; Figure 16A-16D; Paragraph 0188) to a distal portion of the fluid permeable body at least partially positioned proximate to the distal end region of the fluid impermeable barrier (distal portion of permeable layer 1690D and outer wicking layer 1690E is at the distal end region of the collection member; Figure 16A-16C), the fluid permeable body being positioned between the bottom portion and a top portion of the fluid impermeable barrier (permeable layer 1690D and outer wicking layer 1690E within the cavity 1638 and between top wall 1690B and bottom wall 1690A; Figure 16A-16D; Paragraph 0188), and
drawing the urine from the distal portion of the fluid permeable body through the tube (urine is drawn from permeable layer 1690D and wicking layer 1690E to the tube 1679; Paragraph 0193-0194). The embodiment of Figures 16A-16C of Ecklund does not teach the tube extending through an aperture in the top portion of the fluid impermeable barrier.
However, the embodiment of Figures 10A-10C of Ecklund teaches the tube extending through an aperture in the top portion of the fluid impermeable barrier (outlet 1030 on the top wall 1090A; Paragraph 0154-0156; Figures 10A-10C).
Since the prior art of Ecklund recognized the equivalency of having the outlet on the top wall or at the distalmost point (Paragraph 0169) in the field of external urinary catheters, it would have been obvious to a person having ordinary skill in the art to substitute the aperture to be at the top wall instead of the distal most point configuration since it is recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so, with the predictable result of wicking urine away from the genitalia. The simple substitution of one known element for another is obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). The combination of Ecklund does not teach drawing urine discharged by the penis in the chamber through two arms of a fluid permeable body and the two arms being spaced from one another and extending from the distal portion of the fluid permeable body.
However, Cheng teaches drawing urine discharged by the penis in the chamber through two arms of a fluid permeable body and the two arms being spaced from one another and extending from the distal portion of the fluid permeable body (y-shaped fluid permeable layer 260 has two arms and extend towards the proximal end region from the distal portion for drawing urine; Paragraph 0103 and 0118; Figure 1).
Ecklund and Cheng are both considered to be analogous to the claimed invention because they are in the same field of external urinary catheter. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ecklund to have the to incorporate the teachings of Cheng and have the permeable layer of Ecklund to be Y-shaped, as taught by Cheng, with the method of collecting urine, as taught by Cheng. This allows for the wicking material to be shaped for wicking urine away from the male genitalia (Cheng; Paragraph 0103 and 0118). The combination of Ecklund in view of Cheng does not teach the tube extending outside the chamber from the aperture at least partially towards the proximal end region of the fluid impermeable barrier.
However, Davis teaches the tube extending outside the chamber from the aperture at least partially towards the proximal end region of the fluid impermeable barrier (tube 32 extends out from port 31 is angled towards the proximal end region of the fluid impermeable barrier 40; Figures 27A-27C; Paragraph 0103).
Ecklund in view of Cheng and Davis are both considered to be analogous to the claimed invention because they are in the same field of external urinary catheter. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ecklund in view of Cheng to have the to incorporate the teachings of Davis and have the aperture and tube of Ecklund in view of Cheng be angled to have the tube extend toward the proximal end, as taught by Davis. This allows for the tube to be fixed to a hook when not in use so that the tube does not get pulled out from the device by accident (Davis; Paragraph 0101).
Regarding claim 24, Ecklund in view of Cheng and Davis teaches the method of claim 23. The combination of Ecklund in view of Cheng and Davis further teaches wherein drawing the urine from the distal portion of the fluid permeable body through the tube includes drawing the urine from the distal portion of the fluid permeable body through a tube opening (Ecklund; tube opening is at tube end for urine drainage; Figure 16A-16C; Paragraph 0193-0195) in the tube that is covered by the distal portion of the fluid permeable body (distal portion of Y-shaped fluid permeable material covers tube opening and extends past tube opening; Cheng – Figure 1; Ecklund; Figure 16A-16C).
Regarding claim 26, Ecklund in view of Cheng and Davis teaches the method of claim 23. The combination of Ecklund in view of Cheng and Davis further teaches wherein drawing urine discharged by the penis in the chamber through two arms of a fluid permeable body to a distal portion of the fluid permeable body includes drawing the urine through an outer fluid permeable wicking material and a fluid permeable porous fiber structure on each of the two arms to the distal portion of the fluid permeable body (Ecklund; permeable layer 1690D and outer wicking layer 1690E within the cavity 1638 to wick urine through and towards the tube; Figure 16A-16D; Paragraph 0188; Cheng; Y-shaped fluid permeable material with two arms and distal portion to pull urine through and towards the tube; Figure 1; see combination of claim 23 above).
Regarding claim 27, Ecklund in view of Cheng and Davis teaches the method of claim 26. The combination of Ecklund in view of Cheng and Davis further teaches wherein drawing the urine through an outer fluid permeable wicking material and a fluid permeable porous fiber structure on each of the two arms to the distal portion of the fluid permeable body includes drawing the urine through the outer fluid permeable wicking material and the fluid permeable porous fiber structure on each of the two arms to a fluid permeable porous fiber structure of the distal portion of the fluid permeable body that is continuous with the fluid permeable porous fiber structure of the two arms (Ecklund; permeable layer 1690D and outer wicking layer 1690E of fluid permeable layer within the cavity 1638 to wick urine through and towards the tube; Figure 16A-16D; Paragraph 0188; Cheng; Y-shaped fluid permeable material with two arms and distal portion to pull urine through and towards the tube; Figure 1; see combination of claim 23 above).
Regarding claim 28, Ecklund in view of Cheng and Davis teaches the method of claim 23. The combination of Ecklund in view of Cheng and Davis further teaches wherein drawing urine discharged by the penis in the chamber through two arms of a fluid permeable body to a distal portion of the fluid permeable body includes drawing the urine discharged by the penis in the chamber through the two arms of the fluid permeable body positioned at opposing edges of the chamber (Cheng; two arms of Y-shape fluid permeable material is positioned at the left and right edges of the chamber; Figure 1) as the chamber narrows to a tip proximate the distal portion of the fluid permeable body (Ecklund; collection member narrows from the proximal end region to a tip at the distal end region; Figure 16A-16C).
Regarding claim 29, Ecklund in view of Cheng and Davis teaches the method of claim 23. The combination of Ecklund in view of Cheng and Davis does not teach further comprising drawing the urine discharged by the penis in the chamber through one or more additional arms of the fluid permeable body to the distal portion of the fluid permeable body.
However, since the applicant has not disclosed that having an additional arm extending from the distal portion does anything more than produce predictable results (i.e. provide additional wicking pathways for urine to travel through), the mere duplication of the arm is not considered to have patentable significance. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made, to modify Ecklund in view of Cheng and Davis to have an additional arm between the first and second arm of Ecklund in view of Cheng and Davis, in order to predictably wick urine away from the genitalia of the user. The mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See in re Harza, 124 USPQ 378 (CCPA 1960) (see MPEP § 2144.04).
The combination of Ecklund in view of Cheng and Davis further teaches the one or more additional arms being positioned within the chamber between the first arm and the second arm (see combination above).
Regarding claim 30, Ecklund in view of Cheng and Davis teaches the method of claim 23. The combination of Ecklund in view of Cheng and Davis further teaches wherein drawing urine discharged by the penis in the chamber through two arms of a fluid permeable body to a distal portion of the fluid permeable body includes drawing urine discharged by the penis in the chamber through the two arms of the fluid permeable body to the distal portion of the fluid permeable body being at least covered by a fluid impermeable membrane that holds the urine in the distal portion of the fluid permeable body (Ecklund; permeable layer 1690D and outer wicking layer 1690E of fluid permeable layer within the cavity 1638 to wick urine through and towards the tube and fluid permeable layer is covered by the fluid impermeable collection member to hold urine in the distal portion of the fluid permeable body for draining; Figure 16A-16D; Paragraph 0188 and 0193-0194; Cheng; Y-shaped fluid permeable material with two arms and distal portion to pull urine through and towards the tube; Figure 1; see combination of claim 23 above).
Claim(s) 7-11, 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ecklund et al. (Publication No. US 2019/0247222 A1) in view of Cheng et al. (Publication No. US 2004/0006321 A1) and Davis et al. (Publication No. US 2018/0228642 A1), as applied to claim 1 above, and further in view of Ishikawa (Patent No. US 5,735,837 A).
Regarding claim 7, Ecklund in view of Cheng and Davis teaches the device of claim 1. The combination of Ecklund in view of Cheng and Davis further teaches wherein the distal portion of the fluid permeable body includes a continuous substantially planar surface (Ecklund; permeable layer 1690D and outer wicking layer 1690E has a continuous planar surface; Figure 16A; Cheng; Y-shaped permeable material has a first arm, second arm, and distal portion; Figure 1; Paragraph 0103 and 0118; see rejection of claim 1 above). The combination of Ecklund in view of Cheng and Davis does not teach wherein the distal portion of the fluid permeable body extends from the distal end region of the fluid impermeable barrier to the opening.
However, Ishikawa teaches wherein the distal portion of the fluid permeable body extends from the distal end region of the fluid impermeable barrier to the opening (liquid absorbent sheet 2 on the front wall section 10 extends from the distal end region to the opening at cut 15; Figure 1-3; Column 1, lines 57 to Column 2, line 6).
Ecklund in view of Cheng and Davis and Ishikawa are both considered to be analogous to the claimed invention because they are in the same field of urinary collection devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ecklund in view of Cheng and Davis to have the to incorporate the teachings of Ishikawa and have the permeable layer of Ecklund in view of Cheng and Davis to be shaped to have a fluid permeable body from the distal end region to the opening and the two arms surrounding the opening, as taught by Ishikawa. This allows for the permeable material to extensively capture fluid across the length of the device (Ishikawa; Figure 1 and 2; Column 1, lines 57-61).
Regarding claim 8, Ecklund in view of Cheng, Davis, and Ishikawa teaches the device of claim 7. The combination of Ecklund in view of Cheng, Davis, and Ishikawa further teaches wherein the first arm and the second arm extend at least partially around the opening (Ishikawa; first and second arm around the cut 15; Figure 1 and 3; Column 2, lines 7-20).
Regarding claim 9, Ecklund in view of Cheng, Davis, and Ishikawa teaches the device of claim 8. The combination of Ecklund in view of Cheng, Davis, and Ishikawa further teaches wherein the first arm includes a first terminal end and the second arm includes a second terminal end adjacent to the first terminal end (Ishikawa; first and second arm both have terminal ends at portions 20 and 21; Figure 1 and 3; Column 2, lines 7-20), the opening being positioned between the distal portion and the first terminal end and the second terminal end (Ishikawa; cut 15 is between the distal portion of Ecklund in view of Cheng, Davis, and Ishikawa and the first and second terminal ends 20 and 21; Figure 1 and 3; Column 2, lines 7-20).
Regarding claim 10, Ecklund in view of Cheng, Davis, and Ishikawa teaches the device of claim 9. The combination of Ecklund in view of Cheng, Davis, and Ishikawa further teaches wherein:
the fluid impermeable barrier narrows from the proximal end region to a tip at the distal end region (Ecklund; collection member narrows from the proximal end region to a tip at the distal end region; Figure 16A-16C) and includes a first edge and a second edge extending at least partially between the distal end region and the proximal end region (Ecklund; left and right edge extends between the distal end and proximal end region; Figure 16A-16C);
the distal portion of the fluid permeable body is positioned at least proximate to at least a portion of the first edge and at least a portion of the second edge (Ishikawa; distal portion of sheet 3 is between the first and second edge or left and right edge; Figure 1-3);
the first arm is positioned at least proximate to at least a portion of the first edge such that the fluid permeable body extends continuously along the first edge from the distal end region of the fluid impermeable barrier beyond at least a portion of the opening (Ishikawa; first/left arm is adjacent to the left edge where the sheet 3 extends from the left edge from the distal end region and up to past the opening/cut 15; Figure 1 and 3); and
the second arm is positioned at least proximate to at least a portion of the second edge such that the fluid permeable body extends continuously along the second edge from the distal end region of the fluid impermeable barrier beyond at least a portion of the opening (Ishikawa; second/right arm is adjacent to the right edge where the sheet 3 extends from the right edge from the distal end region and up to past the opening/cut 15; Figure 1 and 3).
Regarding claim 11, Ecklund in view of Cheng, Davis, and Ishikawa teaches the device of claim 9. The combination of Ecklund in view of Cheng, Davis, and Ishikawa further teaches wherein:
the fluid impermeable barrier narrows from the proximal end region to a tip at the distal end region (Ecklund; collection member narrows from the proximal end region to a tip at the distal end region; Figure 16A-16C) and includes a first edge and a second edge extending at least partially between the distal end region and the proximal end region (Ecklund; left and right edge extends between the distal end and proximal end region; Figure 16A-16C);
the distal portion of the fluid permeable body is spaced between the first edge and the second edge (Ishikawa; distal portion of sheet 3 is spaced between the first/left edge and second/right edge; Figure 1 and 3);
the first arm curls around a portion of the opening and is spaced from the first edge (Ishikawa; first/left arm curls around cut 15 and is spaced from left edge; Figure 1 and 3); and
the second arm curls around a portion of the opening and is spaced from the second edge (Ishikawa; first/left arm curls around cut 15 and is spaced from left edge; Figure 1 and 3).
Regarding claim 17, Ecklund in view of Cheng and Davis teaches the device of claim 12. The combination of Ecklund in view of Cheng and Davis does not teach wherein the first arm, the second arm, and the distal portion of the fluid permeable body form a V-shaped configuration.
However, Ishikawa teaches wherein the first arm, the second arm, and the distal portion of the fluid permeable body form a Y-shape, V-shape, or U-shape configuration (Column 2, lines 7-20).
Since the prior art of Ishikawa recognized the equivalency of Y-shaped and V-shaped configurations of the fluid permeable material in the field of external urinary catheters, it would have been obvious to a person having ordinary skill in the art to substitute the Y-shaped configuration with the V-shaped configuration since it is recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so, with the predictable result of wicking urine away from the genitalia. The simple substitution of one known element for another is obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding claim 18, Ecklund in view of Cheng and Davis teaches the device of claim 12. The combination of Ecklund in view of Cheng and Davis does not teach wherein the first arm, the second arm, and the distal portion of the fluid permeable body form a U-shaped configuration.
However, Ishikawa teaches wherein the first arm, the second arm, and the distal portion of the fluid permeable body form a Y-shape, V-shape, or U-shape configuration (Column 2, lines 7-20).
Since the prior art of Ishikawa recognized the equivalency of Y-shaped and V-shaped configurations of the fluid permeable material in the field of external urinary catheters, it would have been obvious to a person having ordinary skill in the art to substitute the Y-shaped configuration with the V-shaped configuration since it is recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so, with the predictable result of wicking urine away from the genitalia. The simple substitution of one known element for another is obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Claim(s) 20 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Ecklund et al. (Publication No. US 2019/0247222 A1) in view of Cheng et al. (Publication No. US 2004/0006321 A1) and Davis et al. (Publication No. US 2018/0228642 A1), as applied to claim 1 above, and further in view of Sanchez et al. (Publication No. US 2017/0266031 A1).
Regarding claim 20, Ecklund in view of Cheng and Davis teaches the device of claim 1. The Ecklund in view of Cheng and Davis teaches wherein: the top portion of the fluid impermeable barrier defines an aperture with the tube extending therethrough (Ecklund; outlet 1030 on the top wall 1090A; Paragraph 0154-0156; Figures 10A-10C), the urine collection device being configured to be substantially horizontal during use with the fluid permeable body and the bottom portion of the fluid impermeable barrier being substantially horizontal (Ecklund; collection member is horizontal with the fluid permeable body and is fully capable in operating in this configuration; Figure 16A-16C).
The combination of Ecklund in view of Cheng and Davis does not teach the end of the tube positioned in the chamber includes a beveled end with the tube opening positioned at the beveled end.
However, Sanchez teaches the end of the tube positioned in the chamber includes a beveled end with the tube opening positioned at the beveled end (tube 1621 has a beveled intake at its opening end that can be placed in the reservoir; Paragraph 0159).
Ecklund in view of Cheng and Davis and Sanchez are both considered to be analogous to the claimed invention because they are in the same field of external urinary catheter. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ecklund in view of Cheng and Davis to have the to incorporate the teachings of Sanchez and have the tube of Ecklund in view of Cheng and Davis to be beveled, as taught by Sanchez. This prevents the reservoir material to obstruct the tube (Sanchez; Paragraph 0159).
The combination of Ecklund in view of Cheng and Davis and Sanchez further teaches the tube angles relative to distal portion of the fluid permeable body from the beveled end towards the aperture and out of the chamber (beveled tubing of Sanchez is angled away from the port 978 and out of chamber/reservoir of Ecklund in view of Cheng and Davis; see combination above).
Regarding claim 31, Ecklund in view of Cheng and Davis teaches the method of claim 23. The embodiment of Figures 16A-16C of Ecklund further teaches further comprising positioning the urine collection device substantially horizontal on the user (collection member is horizontal with the fluid permeable body and is fully capable in operating in this configuration; Figure 16A-16C). The combination of Ecklund in view of Cheng and Davis does not teach wherein drawing the urine from the distal portion of the fluid permeable body through the tube includes drawing urine through a tube opening at a beveled end of the tube positioned on the distal portion of the fluid permeable body.
However, Sanchez teaches wherein drawing the urine from the distal portion of the fluid permeable body through the tube includes drawing urine through a tube opening at a beveled end of the tube positioned on the distal portion of the fluid permeable body (tube 1621 has a beveled intake at its opening end that can be placed in the distal portion of the reservoir; Paragraph 0159).
Ecklund in view of Cheng and Davis and Sanchez are both considered to be analogous to the claimed invention because they are in the same field of external urinary catheter. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ecklund in view of Cheng and Davis to have the to incorporate the teachings of Sanchez and have the tube of Ecklund in view of Cheng and Davis to be beveled, as taught by Sanchez, following the method of collection, as taught by Sanchez. This prevents the reservoir material to obstruct the tube (Sanchez; Paragraph 0159).
The combination of Ecklund in view of Cheng, Davis, and Sanchez further teaches the tube angling relative to the distal portion of the fluid permeable body from the beveled end through an aperture in the fluid impermeable barrier and out of the chamber (beveled tubing of Sanchez is angled away from the port 978 and out of chamber/reservoir of Ecklund in view of Cheng and Davis, see combination above).
Claim(s) 22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Ecklund et al. (Publication No. US 2019/0247222 A1) in view of Cheng et al. (Publication No. US 2004/0006321 A1) and Davis et al. (Publication No. US 2018/0228642 A1), as applied to claim 1 above, and further in view of Sweetser (Patent No. US 6,702,793 B1)
Regarding claim 22, Ecklund in view of Cheng and Davis teaches the device of claim 1. The combination of Ecklund in view of Cheng and Davis does not teach wherein the fluid permeable body includes a protrusion on the distal portion of the fluid permeable body proximate to the distal end region of the fluid impermeable barrier and a pocket defined between the protrusion and the distal portion of the fluid permeable body, the tube opening and the end of the tube being positioned within the pocket.
However, Sweetser teaches wherein the fluid permeable body includes a protrusion on the distal portion of the fluid permeable body proximate to the distal end region of the fluid impermeable barrier (convex shape of absorbent material 13 has forms a protrusion with the base of the two arms which is adjacent to the distal end region of the permeable material 13 and is adjacent to the distal end of the fluid impermeable cup 11; Figure 1; Column 3, lines 44-49) and a pocket defined between the protrusion and the distal portion of the fluid permeable body, the tube opening and the end of the tube being positioned within the pocket (space between the protrusion/base of the two arms of the convex shape and the distal portion of the fluid permeable body 13 where there is an opening and the tube 14 has an opening at the first end 15 for receiving urine from the user; Figure 1; Column 3, lines 44-54).
Ecklund in view of Cheng and Davis and Sweetser are both considered to be analogous to the claimed invention because they are in the same field of external urinary catheter. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ecklund in view of Cheng and Davis to have the to incorporate the teachings of Sweetser and have the fluid permeable layer of Ecklund in view of Cheng and Davis to be convexed to have a protrusion and a pocket, as taught by Sweetser. This allows for the device to have a reservoir adjacent to the tubing to support a volume of fluid for urine drainage (Sweetser; Claim 7; Figure 1).
Regarding claim 25, Ecklund in view of Cheng and Davis teaches the method of claim 23. The combination of Ecklund in view of Cheng and Davis does not teach wherein drawing the urine from the distal portion of the fluid permeable body through the tube includes drawing the urine from the distal portion of the fluid permeable body through a tube opening of the tube positioned in a pocket defined between a protrusion on the fluid permeable body and the distal portion of the fluid permeable body.
However, Sweetser teaches wherein drawing the urine from the distal portion of the fluid permeable body through the tube includes drawing the urine from the distal portion of the fluid permeable body through a tube opening of the tube positioned in a pocket defined between a protrusion on the fluid permeable body and the distal portion of the fluid permeable body (convex shape of absorbent material 13 has forms a protrusion with the base of the two arms which is adjacent to the distal end region of the permeable material 13 and is adjacent to the distal end of the fluid impermeable cup 11 - space between the protrusion/base of the two arms of the convex shape and the distal portion of the fluid permeable body 13 where there is an opening and the tube 14 has an opening at the first end 15 for receiving urine from the user; Figure 1; Column 3, lines 44-54).
Ecklund in view of Cheng and Davis and Sweetser are both considered to be analogous to the claimed invention because they are in the same field of external urinary catheter. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ecklund in view of Cheng and Davis to have the to incorporate the teachings of Sweetser and have the fluid permeable layer of Ecklund in view of Cheng and Davis to be convexed to have a protrusion and a pocket, as taught by Sweetser, with the method of urine collection, as taught by Sweetser. This allows for the device to have a reservoir adjacent to the tubing to support a volume of fluid for urine drainage (Sweetser; Claim 7; Figure 1).
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 KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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 at (571) 270-5879. 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.
/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781
Prosecution Insights