DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/2025 has been entered.
Response to Amendment
Applicant’s amendment filed on 10/10/2025 have been fully considered. Claims 1, 7-9, 16-19, 23, 29-30, 33-43 are pending in this application. Claims 2-3, 20-22, 24, 26-27, and 31-32 are canceled. Claims 1 and 16 are amended. Claims 43 are newly added.
Response to Arguments
Applicant’s arguments, see Remarks, filed 10/10/2025, with respect to the rejection(s) of claim(s) 1, 23, and 36 under 35 U.S.C. 103 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 Therefore, the rejection has been withdrawn.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 Johannes (Publication No. US 2019/0282391 A1) in view of Ecklund et al. (Publication No. US 2019/0247222 A1), Passalaqua et al. (Patent No. US 6,007,526 A), Chang (Patent No. US 5,593,389 A), and Dolan (Patent No. US 7,087,043 B2) with simple substitution rationale (MPEP 2143). The embodiment of Figures 5A-5D of Johannes does not teach the substantially tubular portion of an open cell foam. However, the embodiment of Figures 4A-4E of Johannes teaches that the inner wall of the tubular portion can be made of spun plastic, open cell foam or closed cell foam (Paragraph 0079). Since the prior art of Johannes recognizes the equivalency of spun plastic, open cell foam or closed cell foam as materials to be used in the tubular portion of the device in the field of external urinary devices, it would have been obvious to a person having ordinary skill in the art to substitute the tubular portion of the embodiment of Figures 5A-5D of Johannes with the tubular portion having the inner layer open cell foam of the embodiment of Figures 4A-4C of Johannes since it is recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so. 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 amended claim limitations of claim 1 will be addressed in the rejection below.
Though overall the same prior art references are used herein, at least applicant’s amended
independent claim 1 and the required for continued examination required a change in the grounds of the rejection as detailed below in the prior art rejection.
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.
Claims 1, 7-9, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Johannes (Publication No. US 2019/0282391 A1) in view of Ecklund et al. (Publication No. US 2019/0247222 A1), Passalaqua et al. (Patent No. US 6,007,526 A), Chang (Patent No. US 5,593,389 A), and Dolan (Patent No. US 7,087,043 B2).
Regarding claim 1, Johannes teaches a male fluid collection device (Abstract; Paragraph 0046), comprising:
a body (body 540; Figure 5A and 5B; Paragraph 0082) including a substantially tubular portion (body 540 is substantially tubular; Figure 5A and 5B) having a proximal end (proximal end 542; Figure 5A and 5B; Paragraph 0082), a distal end (distal end 544; Figure 5A and 5B; Paragraph 0082), an inner surface at least partially defining a chamber sized to receive at least a head of a penis therein (internal surface 556 has reservoir 510 to receive male member; Figure 5B; Paragraph 0083-0084), an outer surface (outer surface of device is ring 562 with the ring being integrally formed with the same tubular portion material; Figure 5A and 5B; Paragraph 0083);
a conduit in fluid communication with the chamber (tubing 526 is in communication with reservoir 510; Figure 5B; Paragraph 0082).
The embodiment of Figures 5A-5D of Johannes does not teach the substantially tubular portion of an open cell foam.
However, the embodiment of Figures 4A-4E of Johannes teaches that the inner layer of side wall of the body can be either made of spun plastic, open cell foam or closed cell foam (Paragraph 0079).
Since the prior art of Johannes recognizes the equivalency of spun plastic, open cell foam or closed cell foam as materials to be used in the tubular portion of the device in the field of external urinary devices, it would have been obvious to a person having ordinary skill in the art to substitute the tubular portion of the embodiment of Figures 5A-5D of Johannes with the tubular portion having the inner layer open cell foam of the embodiment of Figures 4A-4C of Johannes since it is recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so. 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.).
Additionally, the tubular body of embodiment of Figures 5A-5D describes a material that is fluid permeable, which is a material property of open cell foam.
The modified Johannes further teaches wherein at least a portion of the outer surface of the substantially tubular portion of the open cell foam forms an outer surface of the male fluid collection device effective to allow air to flow into the chamber through the open cell foam when a vacuum is pulled in the chamber through the conduit (ring 562/outer surface is made of an integral material to sheath 564, which can be the open cell foam material of the tubular body portion and forms an outer surface of the device itself – fully capable of drawing air from environment through the foam and into the chamber; Paragraph 0083; see modification above).
Johannes does not teach a plurality of projections extending inwardly from the inner surface, wherein some projections of the plurality of projections are spaced distally in the chamber from adjacent projections of the plurality of projections; wherein the plurality of projections are sized and positioned to interface the head of the penis as the penis is inserted into the chamber, and are angled from the inner surface of the tubular portion towards the fluid impermeable cap before the penis contacts the plurality of projections such that a notch opening towards the fluid impermeable cap is formed between each projection of the plurality of projections and the inner surface of the tubular portion.
However, Ecklund teaches a plurality of projections extending inwardly from the inner surface (flexible members 118 extends inwardly from inner surface of collection member 112/outer portion of backing member 110; Paragraph 0075-0078; Figure 1B and 5); wherein the plurality of projections are sized and positioned to interface the head of the penis as the penis is inserted into the chamber (flexible members 118 are suited to deflect distally toward collection member and can receive penis of user – implicit that head of penis will be interfaced when in contact with flexible members; Paragraph 0080-0081), and are angled from the inner surface of the tubular portion towards the fluid impermeable cap such that a notch opening towards the fluid impermeable cap is formed between each projection of the plurality of projections and the inner surface of the tubular portion (flexible members deflect distally and angled inwards towards collection member so the size of aperture 124 is expanded to receive the user’s genitalia with overlapping members are angled inwards towards collection member – inherent that members 118 with deflection inwards will create notch opening; Paragraph 0080-0081 and 0115-0116; Figure 1B and 5).
Johannes and Ecklund are both considered to be analogous to the claimed invention because they are in the same field of male urine 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 Johannes to incorporate the teachings of Ecklund to have the overlapping plurality of projections/flexible members of Ecklund to be located in the inner surface of the device of Johannes. This will allow for the device to hold and fit onto the genitalia of the users of different sizes and prevent leakage of urine out of the device (Ecklund; Paragraph 0080, 0098, and 0116).
Johannes and Ecklund does not teach wherein the plurality of projections are angled from the inner surface of the tubular portion towards the fluid impermeable cap before the penis contacts the plurality of projections.
However, Passalaqua teaches wherein the projection is angled from the inner surface of the tubular portion towards the fluid impermeable cap before the penis contacts the projection (flap 16 is interior of sheath and is sloping forwardly towards the end of intermediate portion 14; Figure 2; Column 2, line 61 to Column 3, line 65).
Passalaqua and Johannes in view of Ecklund are both considered to be analogous to the claimed invention because they are in the same field of male urine 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 Johannes in view of Ecklund to incorporate the teachings of Passalaqua to have the overlapping plurality of projections/flexible members of Johannes in view of Ecklund to be angled from the inner surface of the tubular portion towards the fluid impermeable cap before the penis is in contact with the projection, as taught by Passalaqua. This will allow for the flap to effectively seal the male genitalia within the device with limited stretching/resistance (Passalaqua; Column 2, line 61 to Column 3, line 65).
In addition, when there are a finite number of identified, predictable solutions, i.e., having the plurality of projections angled inwardly, outwardly, or not angled, a person of ordinary skill has a good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, i.e. having plurality of projections seal the outer surface of the penis within the device to prevent leakage, it is likely the product is not of innovation but of ordinary skill and common sense. It would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the claimed invention, to modify plurality of projections of Johannes in view of Ecklund, by trying to have the plurality of projections to be angled towards the fluid impermeable cap, since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, is within the abilities of one having ordinary skill. See MPEP 2143(I)(E).
Johannes in view of Ecklund and Passalaqua does not teach wherein some projections of the plurality of projections are spaced distally in the chamber from adjacent projections of the plurality of projections.
Since the applicant has not disclosed that placing some projections of the plurality of projections distally in the chamber from adjacent projections does anything more than produce predictable results (i.e. holds the genitalia of the user in position in the device), the mere duplication of the plurality of projections is not considered to have patentable significance. Therefore it would have been obvious to one having ordinary skill in the art at the effective filling date, to modify Johannes in view of Ecklund, and Passalaqua to include another set of plurality of projections spaced distally in the chamber of the first plurality of projections, in order to predictably provide multiple securements of the flexible members onto the penis 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) (MPEP 2144.04(VI)(B)).
The combination of Johannes in view of Ecklund, and Passalaqua does not teach an adjustable strap positioned and configured to tighten around the tubular portion to secure the body to the penis when at least a portion of the penis is positioned within the chamber, wherein the tubular portion has a C-shaped cross-section that has a slit or gap that is adjustable to a closed orientation to form an O-shaped cross-section when then the adjustable strap is tightened around the tubular portion.
However, Chang teaches an adjustable strap positioned and configured to tighten around the tubular portion to secure the body to the penis when at least a portion of the penis is positioned within the chamber (strips/straps of hook and loop/Velcro material 19/20 that is adjustable and configured to secure the outer condom onto the penis when worn; Figure 7 and 12; Column 5, lines 9-51), wherein the tubular portion has a C-shaped cross-section that has a slit or gap that is adjustable to a closed orientation to form an O-shaped cross-section when then the adjustable strap is tightened around the tubular portion (outer condom 16 is opened with C-shaped cross-section that has a slit 18, adjustable based on the fixing of straps 42 and 43; Column 5, lines 9-51; Figure 7 and 12).
Chang and Johannes in view of Ecklund, and Passalaqua are considered to be analogous to the claimed invention because they are in the same field of male urine 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 Johannes in view of Ecklund and Passalaqua to incorporate the teachings of Chang to have the tubular portion of Johannes in view of Ecklund, and Passalaqua to be shaped as the tubular portion/outer condom, as taught by Chang, with the adjustable strips/straps of Chang. This will allow for the device to be easily fitted/adjusted and removed from the male genitalia (Chang; Column 2, lines 10-54 and Column 5, lines 9-51).
The combination of Johannes in view of Ecklund, Passalaqua, and Chang does not teach wherein proximal projections of the plurality of projections that are proximal of adjacent distal projections of the plurality of projections extend distally past at least a portion of the adjacent distal projections.
However, Dolan teaches wherein proximal projections of the plurality of projections that are proximal of adjacent distal projections of the plurality of projections extend distally past at least a portion of the adjacent distal projections (second elastic sleeve 54 extend distally past a portion of the adjacent first elastic sleeve 50; Figure 2; Column 2, lines 1-15).
Dolan and Johannes in view of Ecklund, Passalaqua, and Chang are considered to be analogous to the claimed invention because they are in the same field of male urine 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 Johannes in view of Ecklund, Passalaqua, and Chang to incorporate the teachings of Dolan to have the plurality of projections of Johannes in view of Ecklund, Passalaqua, and Chang to be spaced with the proximal projections overlapping a part of the distal projections, as taught by Dolan. This will allow for increased leak protection of the urine back out of the opening of the device (Dolan; Column 2, lines 1-15).
Regarding claim 7, Johannes in view of Ecklund, Passalaqua, Chang, and Dolan teaches the male fluid collection device of claim 1. Johannes further teaches wherein the body (body 540; Figure 5A) includes:
a fluid impermeable cap (sump 566 made integral to sheath 564 – made of fluid impermeable material; Figure 5B; Paragraph 0083-0084) secured to the tubular portion (sump 566 attached to body 540; Figure 5B) and including an aperture distal to the tubular portion (distal opening of outlet 520/aperture is distal to body 540; Figure 5B; Paragraph 0089), the fluid impermeable cap and the tubular portion defining the chamber (sump 566 and body 540 form reservoir 510; Figure 5B) and the aperture being configured to receive the conduit effective to provide fluid communication between the chamber and the conduit (distal opening of outlet 520/aperture is configured to have fluid communication between reservoir and tubing 526; Figure 5B);
wherein the tubular portion is secured to the fluid impermeable cap (body 540 is attached to sump 566; Figure 5B; Paragraph 0089) with the fluid impermeable cap terminating distal to the proximal end of the tubular portion such that the at least the portion of the outer surface of the substantially tubular portion of the open cell foam forms the outer surface of the male fluid collection device (sump 566 ends that the proximal end of the tubular portion 540 – open cell foam at ring 562 is the outer surface of tubular portion and is an outer surface of the device; Figure 5B; Paragraph 0083) effective to allow air to flow into chamber through the open cell foam when a vacuum is pulled in the chamber through the conduit (same function can be performed because of the same securement of the tubular portion to the fluid impermeable cap).
Regarding claim 8, Johannes in view of Ecklund, Passalaqua, Chang, and Dolan teaches the male fluid device of claim 7. The combination of Johannes in view of Ecklund, Passalaqua, Chang, and Dolan further teaches the adjustable strap includes at least one of an elastic adjustable strap, a hose clamp, a hook and loop fastener material, or one or more fasteners (Chang; strips/straps of hook and loop/Velcro material 19/20 that is adjustable and configured to secure the outer condom onto the penis when worn; Figure 7 and 12; Column 5, lines 9-51).
Johannes in view of Ecklund, Passalaqua, Chang, and Dolan does not expressly teach the tubular portion includes a shore A durometer of less than about 20.
Johannes teaches that the tubular portion comprises an open cell foam optimized to allow fluid to flow through the permeable foam to the conduit and to receive the penis for urination (Paragraph 0078-0080). As seen in Figure 5B, the inner layer of body 540 and ring 563 are connected to allow for the male genitalia to be inserted into the device through the open proximal end 542. Since both the invention and Johannes teaches the open cell foam in the tubular portion of the device, therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to try foams and materials of a variety of shore A hardness, including a shore A durometer of less than about 20, with a reasonable expectation of providing comfort and conformability of the device to the patient’s anatomy. Furthermore, the modification would be 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05(I)).
Regarding claim 9, Johannes in view of Ecklund, Passalaqua, Chang, and Dolan teaches the male fluid device of claim 7. Johannes further teaches further comprising a fluid permeable material secured to the fluid impermeable cap within the chamber and configured to wick fluid discharged from the penis towards the conduit (fluid permeable support 572 enable fluid to flow towards tubing; Paragraph 0084; annotated Figure 5B).
Regarding claim 16, Johannes in view of Ecklund, Passalaqua, Chang, and Dolan teaches the male fluid collection device of claim 1. The combination of Johannes in view of Ecklund, Passalaqua, Chang, and Dolan further teaches wherein:
the body (Johannes; body 540; Figure 5A) includes a fluid impermeable cap (Johannes; sump 566 made integral to sheath 564 – made of fluid impermeable material; Figure 5B; Paragraph 0083-0084) secured to the tubular portion (Johannes; sump 566 attached to body 540; Figure 5B) and including an aperture distal to the tubular portion (Johannes; distal opening of outlet 520/aperture is distal to body 540; Figure 5B; Paragraph 0089), the fluid impermeable cap and the tubular portion defining the chamber (Johannes; sump 566 and body 540 form reservoir 510; Figure 5B) and the aperture being configured to receive the conduit effective to provide fluid communication between the chamber and the conduit (Johannes; distal opening of outlet 520/aperture is configured to have fluid communication between reservoir and tubing 526; Figure 5B).
Regarding claim 17, Johannes in view of Ecklund, Passalaqua, Chang, and Dolan teaches the male fluid device of claim 16. The combination of Johannes in view of Ecklund, Passalaqua, Chang, and Dolan further teaches wherein:
the adjustable strap includes at least one of an elastic adjustable strap, a hose clamp, a hook and loop fastener material, or one or more fasteners (Chang; strips/straps of hook and loop/Velcro material 19/20 that is adjustable and configured to secure the outer condom onto the penis when worn; Figure 7 and 12; Column 5, lines 9-51);
the tubular portion includes an elastomeric material (Johannes; sheath 564 of body 540 is flexible and formed from a polymer – sheath, sump, and ring are integrally formed; list of polymers – Paragraph 0049; Paragraph 0083 and 0088; Figure 5B);
the plurality of projections include one or more of an elastomer, a silicone, a thermoplastic elastomer, or thermoplastic polyurethane (Ecklund; projections/flexible member of backing layer made of spandex– a type of elastomer; Paragraph 0105).
Johannes in view of Ecklund, Passalaqua, Chang, and Dolan does not teach the plurality of projections have a shore A durometer of about 30 to about 60.
Ecklund teaches that the plurality of projections are made of an elastomer and have the same function of holding the male member in the device and provide a seal for supplying vacuum. Since both the invention and Johannes in view of Ecklund, Passalaqua, Chang, and Dolan teaches the plurality of projections made of elastomer, therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to try elastomers of a variety of shore A hardness, including a shore A durometer of about 30 to about 60, with a reasonable expectation of retaining the male member in the tubular portion while providing comfort to the user. Furthermore, the modification would be 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)(MPEP 2144.05(I)).
Regarding claim 18, Johannes in view of Ecklund, Passalaqua, Chang, and Dolan teaches the male fluid collection device of claim 1. The combination of Johannes in view of Ecklund, Passalaqua, Chang, and Dolan further teaches wherein:
the body (Johannes; body 540; Figure 5A) includes:
a fluid impermeable cap (Johannes; sump 566 made integral to sheath 564 – made of fluid impermeable material; Figure 5B; Paragraph 0083-0084) secured to the tubular portion (Johannes; sump 566 attached to body 540; Figure 5B) and including an aperture distal to the tubular portion (Johannes; distal opening of outlet 520/aperture is distal to body 540; Figure 5B; Paragraph 0089), the fluid impermeable cap and the tubular portion defining the chamber (Johannes; sump 566 and body 540 form reservoir 510; Figure 5B) and the aperture being configured to receive the conduit effective to provide fluid communication between the chamber and the conduit (Johannes; distal opening of outlet 520/aperture is configured to have fluid communication between reservoir and tubing 526; Figure 5B); and
the adjustable strap includes a hook and loop material fastener strap positioned and configured to tighten around the tubular portion to secure the body to the penis when at least a portion of the penis is positioned within the chamber (Chang; strips/straps of hook and loop/Velcro material 19/20 that is adjustable and configured to secure the outer condom onto the penis when worn; Figure 7 and 12; Column 5, lines 9-51).
Claims 23, 26, and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Johannes (Publication No. US 2019/0282391 A1) in view of Ecklund et al. (Publication No. US 2019/0247222 A1), Passalaqua et al. (Patent No. US 6,007,526 A), and Chang (Patent No. US 5,593,389 A).
Regarding claim 23, Johannes teaches a method of collecting fluid from a male (Abstract), the method comprising:
inserting at least a head of a penis of a user within a chamber (Paragraph 0088) defined by a tubular portion of a body of a fluid collection device (reservoir 510 is defined in body 540; Figure 5B); and
receiving fluids discharged from the penis into the chamber of the fluid collection device (Paragraph 0084-0085);
and pulling the fluid in the chamber through a conduit with a vacuum force applied to the conduit (pump can be connected to conduit 526 to pull fluid from chamber of device; Paragraph 0056, 0078, and 0082), the tubular portion including an outer surface (outer surface of device is ring 562 with the ring being integrally formed with the same tubular portion material; Figure 5A and 5B; Paragraph 0083).
The embodiment of Figures 5A-5D of Johannes does not teach the tubular portion of an open cell foam.
However, the embodiment of Figures 4A-4E of Johannes teaches that the inner layer of side wall of the body can be either made of spun plastic, open cell foam or closed cell foam (Paragraph 0079).
Since the prior art of Johannes recognizes the equivalency of spun plastic, open cell foam or closed cell foam as materials to be used in the tubular portion of the device in the field of external urinary devices, it would have been obvious to a person having ordinary skill in the art to substitute the tubular portion of the embodiment of Figures 5A-5D of Johannes with the tubular portion having the inner layer open cell foam of the embodiment of Figures 4A-4C of Johannes since it is recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so. 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.).
Additionally, the tubular body of embodiment of Figures 5A-5D describes a material that is fluid permeable, which is a material property of open cell foam.
The modified Johannes further teaches the tubular portion of the open cell foam including the outer surface that at least partially forms an outer surface of the fluid collection device such that air flow into chamber through that open cell foam (ring 562/outer surface is made of an integral material to sheath 564, which can be the open cell foam material of the tubular body portion and forms an outer surface of the device itself – fully capable of drawing air from environment through the foam and into the chamber; Paragraph 0083; see modification above).
Johannes does not teach a plurality of projections extending inwardly from an inner surface of the tubular portion, some projections of the plurality of projections spaced distally in chamber from adjacent projections of the plurality of projections, wherein the plurality of projections are angled from the inner surface of the tubular portion towards the fluid impermeable cap before the penis contacts the plurality of projections such that a notch opening towards the fluid impermeable cap is formed between each projection of the plurality of projections and the inner surface of the tubular portion, thereby inhibiting the fluid collection device from moving out of position on the penis; securing the body to the penis.
However, Ecklund teaches a plurality of projections extending inwardly from an inner surface of the tubular portion (flexible members 118 extends inwardly from inner surface of collection member 112/outer portion of backing member 110; Paragraph 0075-0078; Figure 1B and 5), wherein the plurality of projections are angled from the inner surface of the tubular portion towards the fluid impermeable cap such that a notch opening towards the fluid impermeable cap is formed between each projection of the plurality of projections and the inner surface of the tubular portion (flexible members deflect distally and angled inwards towards collection member so the size of aperture 124 is expanded to receive the user’s genitalia with overlapping members are angled inwards towards collection member – inherent that members 118 with deflection inwards will create notch opening; Paragraph 0080-0081 and 0115-0116; Figure 1B and 5), thereby inhibiting the fluid collection device from moving out of position on the penis (Paragraph 0080 and 0098).
Johannes and Ecklund are both considered to be analogous to the claimed invention because they are in the same field of male urine 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 Johannes to incorporate the teachings of Ecklund to have the overlapping plurality of projections/flexible members of Ecklund to be located in the inner surface of the device of Johannes. This will provide allow for the device to hold and fit onto the genitalia of the users of different sizes and prevent leakage of urine out of the device (Ecklund; Paragraph 0080, 0098, and 0116).
Johannes in view of Ecklund does not teach wherein the plurality of projections are angled from the inner surface of the tubular portion towards the fluid impermeable cap before the penis contacts the plurality of projections.
However, Passalaqua teaches wherein the projection is angled from the inner surface of the tubular portion towards the fluid impermeable cap before the penis contacts the projection (flap 16 is interior of sheath and is sloping forwardly towards end of intermediate portion 14; Figure 2; Column 2, line 61 to Column 3, line 65).
Passalaqua and Johannes in view of Ecklund are considered to be analogous to the claimed invention because they are in the same field of male urine 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 Johannes in view of Ecklund to incorporate the teachings of Passalaqua to have the overlapping plurality of projections/flexible members of Johannes in view of Ecklund to be angled from the inner surface of the tubular portion towards the fluid impermeable cap before the penis is in contact with the projection, as taught by Passalaqua. This will allow for the flap to effectively seal the male genitalia within the device with limited stretching/resistance (Passalaqua; Column 2, line 61 to Column 3, line 65).
In addition, when there are a finite number of identified, predictable solutions, i.e., having the plurality of projections angled inwardly, outwardly, or not angled, a person of ordinary skill has a good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, i.e. having plurality of projections seal the outer surface of the penis within the device to prevent leakage, it is likely the product is not of innovation but of ordinary skill and common sense. It would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the claimed invention, to modify plurality of projections of Johannes in view of Ecklund and Passalaqua, by trying to have the plurality of projections to be angled towards the fluid impermeable cap, since choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, is within the abilities of one having ordinary skill. See MPEP 2143(I)(E).
Johannes in view of Ecklund and Passalaqua does not teach wherein some projections of the plurality of projections are spaced distally in the chamber from adjacent projections of the plurality of projections.
Since the applicant has not disclosed that placing some projections of the plurality of projections distally in the chamber from adjacent projections does anything more than produce predictable results (i.e., holds the genitalia of the user in position in the device), the mere duplication of the plurality of projections is not considered to have patentable significance. Therefore it would have been obvious to one having ordinary skill in the art at the effective filling date, to modify Johannes in view of Ecklund and Passalaqua to include another set of plurality of projections spaced distally in the chamber of the first plurality of projections, in order to predictably provide multiple securements of the flexible members onto the penis 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) (MPEP 2144.04(VI)(B)).
The combination of Johannes in view of Ecklund, and Passalaqua does not teach securing the body to the penis by tightening an adjustable strap around the body, thereby adjusting from a C-shaped cross-section having a slit or gap to a closed orientation having an O- shaped cross-section.
However, Chang teaches securing the body to the penis by tightening an adjustable strap around the body (strips/straps of hook and loop/Velcro material 19/20 that is adjustable and configured to secure the outer condom onto the penis when worn; Figure 7 and 12; Column 5, lines 9-51), thereby adjusting from a C-shaped cross-section having a slit or gap to a closed orientation having an O- shaped cross-section (outer condom 16 is opened with C-shaped cross-section that has a slit 18, adjustable based on the fixing of straps 42 and 43; Column 5, lines 9-51; Figure 7 and 12).
Chang and Johannes in view of Ecklund and Passalaqua are considered to be analogous to the claimed invention because they are in the same field of male urine 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 Johannes in view of Ecklund and Passalaqua to incorporate the teachings of Chang to have the tubular portion of Johannes in view of Ecklund and Passalaqua to be shaped as the tubular portion/outer condom, as taught by Chang, with the adjustable strips/straps and the method of securement of Chang. This will allow for the device to be easily fitted/adjusted and removed from the male genitalia (Chang; Column 2, lines 10-54 and Column 5, lines 9-51).
Regarding claim 29, Johannes in view of Ecklund, Passalaqua, and Chang teaches the method of claim 23. The combination of Johannes in view of Ecklund, Passalaqua, and Chang further teaches wherein securing the body to the penis with one or more securement elements includes securing a hook and loop material fastener strap around a tubular portion of the body (strips/straps of hook and loop/Velcro material 19/20 that is adjustable and configured to secure the outer condom onto the penis when worn; Figure 7 and 12; Column 5, lines 9-51).
Regarding claim 33, Johannes in view of Ecklund, Passalaqua, and Chang teaches the method of claim 23. The combination of Johannes in view of Ecklund, Passalaqua, and Chang further teaches further comprising removing the fluid collection device from the penis by pinching the tubular portion, thereby separating a portion of the plurality of projections from the penis. It is implicit that the flexible material of the tubular portion of Johannes and the flexible projections of Ecklund would allow for the user to remove the device by pinching or grasping the tubular portion, which will deform the flexible members that causes the aperture, as taught by Ecklund, bigger or reshape for removal of the genitalia.
Regarding claim 34, Johannes in view of Ecklund, Passalaqua, and Chang teaches the device of claim 1. The combination of Johannes in view of Ecklund, Passalaqua, and Chang further teaches further comprising:
a fluid impermeable cap (Johannes; sump 566 made integral to sheath 564 – made of fluid impermeable material; Figure 5B; Paragraph 0083-0084) secured to the tubular portion (Johannes; sump 566 attached to body 540; Figure 5B) and including an aperture distal to the tubular portion (Johannes; distal opening of outlet 520/aperture is distal to body 540; Figure 5B; Paragraph 0089); and
a fluid permeable material secured to the fluid impermeable cap within the chamber (Johannes; fluid permeable materials 572 and 574 is secured to sump 566; Paragraph 0084-0090; Figure 5B) and a reservoir of void space positioned in the fluid impermeable cap between the fluid permeable material and the aperture (volume of outlet 520 is a void space in sump 566 and between aperture and permeable materials 572 and 574; Figure 5B; Paragraph 0084-0090), wherein the fluid permeable material is configured to wick fluid discharged from the penis into the reservoir and towards the conduit (Johannes; Paragraphs 0084-0090).
Regarding claim 35, Johannes in view of Ecklund, Passalaqua, and Chang teaches the device of claim 1. The combination of Johannes in view of Ecklund, Passalaqua, and Chang further teaches wherein the adjustable strap includes at least one of an elastic adjustable strap, a hose clamp, a hook and loop fastener material, or one or more fasteners (Chang; strips/straps of hook and loop/Velcro material 19/20 that is adjustable and configured to secure the outer condom onto the penis when worn; Figure 7 and 12; Column 5, lines 9-51).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Johannes (Publication No. US 2019/0282391 A1) in view of Ecklund et al. (Publication No. US 2019/0247222 A1), Passalaqua et al. (Patent No. US 6,007,526 A), Chang (Patent No. US 5,593,389 A) and Dolan (Patent No. US 7,087,043 B2), as applied to claim 1 above, and further in view of Forsell (Publication No. US 2011/0087337 A1).
Regarding claim 19, Johannes in view of Ecklund, Passalaqua, Chang, and Dolan teaches the male fluid collection device of claim 1. The combination of Johannes in view of Ecklund, Passalaqua, Chang, and Dolan wherein: the body (Johannes; body 540; Figure 5A) includes:
a fluid impermeable cap (Johannes; sump 566 made integral to sheath 564 – made of fluid impermeable material; Figure 5B; Paragraph 0083-0084) secured to the tubular portion (Johannes; sump 566 attached to body 540; Figure 5B) and including an aperture distal to the tubular portion (Johannes; distal opening of outlet 520/aperture is distal to body 540; Figure 5B; Paragraph 0089), the fluid impermeable cap and the tubular portion defining the chamber (Johannes; sump 566 and body 540 form reservoir 510; Figure 5B) and the aperture being configured to receive the conduit effective to provide fluid communication between the chamber and the conduit (Johannes; distal opening of outlet 520/aperture is configured to have fluid communication between reservoir and tubing 526; Figure 5B).
The combination of Johannes in view of Ecklund, Passalaqua, Chang, and Dolan does not teach the adjustable strap includes one or more worm drive hose clamps positioned and configured to tighten around the tubular portion to secure the body to the penis when at least a portion of the penis is positioned within the chamber.
However, Forsell teaches one or more worm drive hose clamps positioned and configured to tighten around the tubular portion to secure the body to the penis when at least a portion of the penis is positioned within the chamber (worm-driven hose clamp is placed around a desired position of the patient’s body and can constrict/release around the organ using the clamp; Paragraph 3561 and 3564).
Forsell and Johannes in view of Ecklund, Passalaqua, Chang, and Dolan are considered to be analogous to the claimed invention because they are in the same field of urinary/fluid 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 Johannes in view of Ecklund, Passalaqua, Chang, and Dolan to incorporate the teachings of Forsell to have a securing element/fastener that is a worm-driven hose clamp on the adjustable strap around the tubular portion of the device of Johannes in view of Ecklund, Passalaqua, Chang, and Dolan. This will provide a secure fit of the device onto the desired body organ and enables the device to be removable/securable, as well as being adjusted by a motor and drive shaft (Forsell; Paragraphs 3561 and 3564).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Johannes (Publication No. US 2019/0282391 A1) in view of Ecklund et al. (Publication No. US 2019/0247222 A1), Passalaqua et al. (Patent No. US 6,007,526 A), and Chang (Patent No. US 5,593,389 A), as applied to claim 1 above, and further in view of Forsell (Publication No. US 2011/0087337 A1).
Regarding claim 30, Johannes in view of Ecklund, Passalaqua, and Chang teaches the method of claim 23. The combination of Johannes in view of Ecklund, Passalaqua, and Chang does not teach wherein securing the body to the penis includes tightening one or more worm drive hose clamps around a tubular portion of the body.
However, Forsell teaches wherein securing the body to the penis includes tightening one or more worm drive hose clamps around a tubular portion of the body (worm-driven hose clamp is placed around a desired position of the patient’s body and can constrict/release around the organ using the clamp; Paragraph 3561 and 3564).
Forsell and Johannes in view of Ecklund, Passalaqua, and Chang are both considered to be analogous to the claimed invention because they are in the same field of urinary/fluid 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 Johannes in view of Ecklund, Passalaqua, and Chang to incorporate the teachings of Forsell to have a securing element/fastener that is a worm-driven hose clamp around the tubular portion of the device of Johannes. This will provide a secure fit of the device onto the desired body organ and enables the device to be removable/securable as well as being adjusted by a motor and drive shaft (Forsell; Paragraphs 3561 and 3564).
Claims 36-42 are rejected under 35 U.S.C. 103 as being unpatentable over Johannes (Publication No. US 2019/0282391 A1) in view of Chang (Patent No. US 5,593,389 A).
Regarding claim 36, Johannes teaches a male fluid collection device (Abstract; Paragraph 0046), comprising: a body (body 540; Figure 5A and 5B; Paragraph 0082) including a substantially tubular portion (body 540 is substantially tubular; Figure 5A and 5B) and having a proximal end (proximal end 542; Figure 5A and 5B; Paragraph 0082), a distal end (distal end 544; Figure 5A and 5B; Paragraph 0082), an inner surface at least partially defining a chamber sized to receive at least a head of a penis therein (internal surface 556 has reservoir 510 to receive male member; Figure 5B; Paragraph 0083-0084), an outer surface (outer surface of device is ring 562 with the ring being integrally formed with the same tubular portion material; Figure 5A and 5B; Paragraph 0083);
a conduit in fluid communication with the chamber tubing 526 is in communication with reservoir 510; Figure 5B; Paragraph 0082). The embodiment of Figures 5A-5D of Johannes does not teach the substantially tubular portion of an open cell foam.
However, the embodiment of Figures 4A-4E of Johannes teaches that the inner layer of side wall of the body can be either made of spun plastic, open cell foam or closed cell foam (Paragraph 0079).
Since the prior art of Johannes recognizes the equivalency of spun plastic, open cell foam or closed cell foam as materials to be used in the tubular portion of the device in the field of external urinary devices, it would have been obvious to a person having ordinary skill in the art to substitute the tubular portion of the embodiment of Figures 5A-5D of Johannes with the tubular portion having the inner layer open cell foam of the embodiment of Figures 4A-4C of Johannes since it is recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so. 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.).
Additionally, the tubular body of embodiment of Figures 5A-5D describes a material that is fluid permeable, which is a material property of open cell foam.
The modified Johannes further teaches wherein at least a portion of the outer surface of the substantially tubular portion of the open cell foam forms an outer surface of the male fluid collection device effective to allow air to flow into the chamber through the open cell foam when a vacuum is pulled in the chamber through the conduit (ring 562/outer surface is made of an integral material to sheath 564, which can be the open cell foam material of the tubular body portion and forms an outer surface of the device itself – fully capable of drawing air from environment through the foam and into the chamber; Paragraph 0083; see modification above).
The modified Johannes does not teach an adjustable strap positioned and configured to tighten around the tubular portion to secure the body to the penis when at least a portion of the penis is positioned within the chamber (strips/straps of hook and loop/Velcro material 19/20 that is adjustable and configured to secure the outer condom onto the penis when worn; Figure 7 and 12; Column 5, lines 9-51).
Chang and Johannes are considered to be analogous to the claimed invention because they are in the same field of male urine 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 v to incorporate the teachings of Chang to have the tubular portion of Johannes to be shaped as the tubular portion/outer condom, as taught by Chang, with the adjustable strips/straps of Chang. This will allow for the device to be easily fitted/adjusted and removed from the male genitalia (Chang; Column 2, lines 10-54 and Column 5, lines 9-51).
Regarding claim 37, Johannes in view of Chang teaches the device of 36. Johannes further teaches wherein the body (body 540; Figure 5A) includes: a fluid impermeable cap (sump 566 made integral to sheath 564 – made of fluid impermeable material; Figure 5B; Paragraph 0083-0084) secured to the tubular portion (sump 566 attached to body 540; Figure 5B) and including an aperture distal to the tubular portion (distal opening of outlet 520/aperture is distal to body 540; Figure 5B; Paragraph 0089), the fluid impermeable cap and the tubular portion defining the chamber (sump 566 and body 540 form reservoir 510; Figure 5B) and the aperture being configured