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 .
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.
Claim(s) 2-8,10-12,15-21,23,25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brun et al. US 2019/0247223 in view of Cheng et al. US 2004/0176731, hereafter Brun and Cheng, both provided in the IDS.
Regarding Claim 2, Brun discloses A fluid collection assembly (figure 1), comprising: a fluid impermeable barrier defining a chamber (para. 0049, where the funnel wall is non-absorbent and the interior of the wall is interpreted as a chamber), at least one opening (1), and at least one fluid outlet (20); and at least one inflatable bladder configurable between a first state and at least a second state (ring (5) para. 0041, where a first state is not inflated and the second state is inflated, see also para. 0050); wherein the fluid impermeable barrier exhibits a first dimension measured when the at least one inflatable bladder exhibits the first state and a second dimension when the at least one inflatable bladder exhibits the second state, the first dimension less than the second dimension, the first dimension and the second dimension are a width measured perpendicular to a longitudinal axis of the fluid collection assembly or a length measured parallel to the longitudinal axis (para. 0041, 0051). The examiner notes that as the ring, understood to be an inflatable member, is on an external surface of the collection device, and would expand upon inflation, where the expansion would increase the dimensions of the inflatable member in both a parallel and perpendicular direction to a longitudinal axis, Brun is interpreted to read to the claimed invention. As the member fills with air and since it is rounded in shape, it is interpreted that air would push all sides of the flexible ring outward thus increasing both a width and length of the collection device. As seen in figure 9 and 10, the ring extends past the funnel and thus lends itself to this interpretation.
Further, the examiner notes per para. 0047, the funnel shape may be made to accommodate a urethra configuration, where the device provides a seal against the user. As such it is interpreted as being disposed adjacent to a urethra opening of an individual, switching the at least one inflatable bladder between the first state and at least the second state causes the fluid collection assembly to better conform to one or more anatomical features of the individual.
Brun however, fails to teach at least one porous material at least partially disposed of in the chamber. The drainage tube (20) of Brun may be a tube or connect to other fluid collection devices (para. 0039).
Cheng teaches a urine collection device, and it thus considered analogous to the claimed invention. Cheng teaches external collection devices where figure 2B depicts a wicking spacer element (260) including tube wicking spacer (106) to aid in flow out of the sheath to a further collection component (para. 0036). Figure 2B depicts this configuration for a male collection device, where figure 4B depicts this with a female collection device. The spacer may be a porous material (para. 0123) Therefore, as Cheng teaches that both male and female external collection devices may comprise porous wicking spacer members for directing fluid from a collection interface to a further container, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a porous wicking member within the collection interface of Brun to aid in fluid removal from the interface. Doing so would merely require combining prior art elements according to known methods to yield predictable results, that being the collection and transport of urine, and thus a prima facie case of obviousness exists.
Regarding claim 3, Brun and Cheng teach the fluid collection assembly of claim 2, wherein the at least one inflatable bladder extends generally parallel to longitudinal axis of the fluid impermeable barrier. The examiner notes that as detailed under the rejection of claim 2, the expansion of the ring would cause extension in all directions based on the shape of the ring, including lengthwise away from the fluid impermeable barrier and is thus interpreted to be an extension parallel to the longitudinal axis of the barrier.
Regarding claim 4, Brun and Cheng teach the fluid collection assembly of claim 2, wherein: the fluid impermeable barrier includes two lateral sides on opposing sides of the at least one opening (lateral sides 16 and 18); and at least a portion of the at least one inflatable bladder is adjacent to at least one of the two lateral sides. The examiner notes that as the inflation ring of Brun is a ring that surrounds the opening of the device, it is adjacent to both sides. See figure 1.
Regarding claim 5, Brun and Cheng teach the fluid collection assembly of claim 4, wherein the first dimension and the second dimension are the width. The examiner notes that as detailed under the rejection of claim 2, the ring is interpreted to expand in both a length and width direction, and thus reads to the claim.
Regarding claim 6, Brun and Cheng teach the fluid collection assembly of claim 5, wherein switching the at least one inflatable bladder between the first state and the second state decreases gaps between the labia folds and the fluid collection assembly. While it is not specifically disclosed that the device of Brun and Cheng does this, the device is configured for use in sealing a pelvic area about the urethra for both males and females. Further, per MPEP section 2114 II "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, as the prior art teaches a female urine collection device comprising an impermeable barrier and an inflation device that conforms to the anatomy adjacent to a urethra and extends in both a width and length direction upon inflation as required by the claims, where the decreasing of the gaps between the labia folds is functional language, it is interpreted that the prior art device would perform the same functional language in use and thus reads to the claimed invention.
Regarding claim 7, Brun and Cheng teach the fluid collection assembly of claim 4, wherein the two lateral sides and the at least one inflatable bladder exhibit an elongated shape and extend parallel to each other. The examiner notes that as seen in figure 1, the lateral sides and the bladder both exhibit an elongated shape. As the bladder does extend, at least partially, in a lengthwise direction parallel to the lateral sides, it is interpreted to read to the instant limitation.
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Regarding claim 8, Brun and Cheng teach the fluid collection assembly of claim 4, wherein the at least one inflatable bladder contacts an outer surface of the two lateral sides of the fluid impermeable barrier (see figure 1).
Regarding claim 10, Brun and Cheng teach the fluid collection assembly of claim 4, wherein the fluid impermeable barrier includes a proximal end region (Brun figure 1, end (12)) and a distal end region (Brun figure 1, end (14)) opposite the proximal end region, the at least one inflatable bladder is spaced from the proximal end region and the distal end region.
Regarding claim 11, Brun and Cheng teach the fluid collection assembly of claim 2, wherein the first dimension and the second dimension are the length. The examiner notes that as detailed under the rejection of claim 2, the ring is interpreted to expand in both a length and width direction and thus reads to the claim.
Regarding claim 12, Brun and Cheng teach the fluid collection assembly of claim 2, wherein the at least one inflatable bladder including a first inflatable bladder and a second inflatable bladder; and wherein the fluid impermeable barrier exhibits the first dimension and the second dimension when the first inflatable bladder or the second inflatable bladder exhibits the first state and the second state, respectively. The examiner notes that per para. 0042 of Brun, the raised ring may be divided into a plurality of portions, where the different portions may exhibit different properties (some flexible, some rigid, per para. 0042). Therefore, as the portions may exhibit different properties and are defined as division in the bladder, it is interpreted that the device of Brun may include a plurality of inflatable bladders. As detailed under the rejection of claim 2, inflation of the bladder(s) increases both a length and width of the overall device and thus the device of Brun and Cheng reads to the claimed limitation.
Regarding claim 15, Brun and Cheng teach the fluid collection assembly of claim 12, wherein the first inflatable bladder is in fluid communication with the second inflatable bladder. The examiner notes that as the defined portions, as seen in figure 2, and based on the disclosure of para. 0042, are configured to work with one other (thus would be inflated together) and are connected with one another, it is interpreted that that a first and second bladder are in fluid communication with one another.
Regarding claim 16, Brun and Cheng teach the fluid collection assembly of claim 2, but fails to specifically teach wherein the first dimension is less than the second dimension by about 1 cm or less.
However, per MPEP section 2144.04 IV A In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. The examiner notes that the claimed dimension lack criticality in view of the applicant’s specification (para. 0057), and as the prior art device includes an inflatable ring that changes the size of the device, where the device is positioned adjacent to the urethra of a patient, modifying the inflation dimensions to be within the claimed range would, in the examiner’s opinion, not alter the functionality of the prior art device. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the inflation dimensions (and thus the dimensions of the device upon inflation) to be within the claimed range.
Regarding claim 17, Brun and Cheng teach the fluid collection assembly of claim 2 but fails to specifically teach wherein the first dimension is less than the second dimension by about 5 mm or less.
However, per MPEP section 2144.04 IV A In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. The examiner notes that the claimed dimension lack criticality in view of the applicant’s specification (para. 0057), and as the prior art device includes an inflatable ring that changes the size of the device, where the device is positioned adjacent to the urethra of a patient, modifying the inflation dimensions to be within the claimed range would, in the examiner’s opinion, not alter the functionality of the prior art device. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the inflation dimensions (and thus the dimensions of the device upon inflation) to be within the claimed range.
Regarding claim 18, Brun and Cheng teach the fluid collection assembly of claim 2, wherein the at least one inflatable bladder is spaced from the chamber. The examiner notes that as the inflation component lies around the opening, where the opening forms an entrance into the chamber, it is interpreted that the inflation component is spaced apart from the chamber, by way of the opening.
Regarding claim 19, Brun and Cheng teach the fluid collection assembly of claim 2, wherein the at least one inflatable bladder is closer to the at least one opening than a back side of the fluid impermeable barrier, the back side of the fluid impermeable barrier is opposite the at least one opening (see figure 1 of Brun). The examiner notes that per figure 1 of Brun the inflatable component surrounds the ring and thus is closer to the ring than any other part of the device. While there is no disclosed “back side” of Brun, the examiner notes that figure 10 of Brun depicts a rear view of the device, and thus this portion is interpreted as the backside, where said side is seen to be opposite the opening (seen in front view in figure 9).
Regarding claim 20, Brun and Cheng teach the fluid collection assembly of claim 2, wherein the at least one inflatable bladder is configured to substantially only contact the labia folds. While the art does not specifically state that the bladder substantially only contacts the labia folds, the examiner notes that as detailed under the rejection of claim 2, the device is configured to be sealed about a user’s urethra. One having ordinary skill in the art would recognize that as the labia fold surrounds the urethra, sealing the device about the urethra would substantially only contact the labia folds.
Regarding claim 21, Brun and Cheng teach the fluid collection assembly of claim 2, further comprising a conduit in fluid communication with the chamber, wherein the conduit is distinct and separate from the at least one inflatable bladder (conduit (20), seen in figure 1 to be in communication with the chamber and distinct from the inflatable bladder).
Regarding claim 23, Brun and Cheng teach the fluid collection assembly of claim 2, further comprising at least one additional inflatable bladder contacting at least an outer surface of a distal end region of the fluid impermeable barrier, the at least one inflatable bladder configured to change a length of the fluid impermeable barrier responsive to flowing at least one inflation fluid into the bladder of the at least one additional inflation device. The examiner notes that per para. 0042 of Brun, the raised ring may be divided into a plurality of portions, where the different portions may exhibit different properties (some flexible, some rigid, per para. 0042). Therefore, as the portions may exhibit different properties and are defined as division in the bladder, it is interpreted that the device of Brun may include a plurality of inflatable bladders. As detailed under the rejection of claim 2, inflation of the bladder(s) increases both a length and width of the overall device and thus the device of Brun and Cheng reads to the claimed limitation.
Regarding claim 25, Brun discloses a method of using a fluid collection assembly, the method comprising: positioning at least one opening of the fluid collection assembly adjacent to a urethral opening (para. 0040-0041), the fluid collection assembly including: a fluid impermeable barrier defining a chamber (para. 0049, where the funnel wall is non-absorbent and the interior of the wall is interpreted as a chamber), at least one opening (1), and at least one fluid outlet (20); and at least one inflatable bladder configurable between a first state and at least a second state(ring (5) para. 0041, where a first state is not inflated and the second state is inflated, see also para. 0050); wherein the fluid impermeable barrier exhibits a first dimension measured when the at least one inflatable bladder exhibits the first state and a second dimension when the at least one inflatable bladder exhibits the second state, the first dimension less than the second dimension , the first dimension and the second dimension are a width measured perpendicular to a longitudinal axis of the fluid collection assembly or a length measured parallel to the longitudinal axis(para. 0041, 0051). The examiner notes that as the ring, understood to be an inflatable member, is on an external surface of the collection device, and would expand upon inflation, where the expansion would increase the dimensions of the inflatable member in both a parallel and perpendicular direction to a longitudinal axis, Brun is interpreted to read to the claimed invention. As the member fills with air and since it is rounded in shape, it is interpreted that air would push all sides of the flexible ring outward thus increasing both a width and length of the collection device. As seen in figure 9 and 10, the ring extends past the funnel and thus lends itself to this interpretation.
Further, the examiner notes per para. 0047, the funnel shape may be made to accommodate a urethra configuration, where the device provides a seal against the user. As such it is interpreted as being disposed adjacent to a urethra opening of an individual, switching the at least one inflatable bladder between the first state and at least the second state causes the fluid collection assembly to better conform to one or more anatomical features of the individual.
Brun however, fails to teach at least one porous material at least partially disposed in the chamber. The drainage tube (20) of Brun may be a tube or connect to other fluid collection devices (para. 0039).
Cheng teaches a urine collection device, and it thus considered analogous to the claimed invention. Cheng teaches external collection devices where figure 2B depicts a wicking spacer element (260) including tube wicking spacer (106) to aid in flow out of the sheath to a further collection component (para. 0036). Figure 2B depicts this configuration for a male collection device, where figure 4B depicts this with a female collection device. The spacer may be a porous material (para. 0123) Therefore, as Cheng teaches that both male and female external collection devices may comprise porous wicking spacer members for directing fluid from a collection interface to a further container, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a porous wicking member within the collection interface of Brun to aid in fluid removal from the interface. Doing so would merely require combining prior art elements according to known methods to yield predictable results, that being the collection and transport of urine, and thus a prima facie case of obviousness exists.
Claim(s) 9,23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brun and Cheng in view of Harvie US 2003/0195484, hereafter Harvie, provided in the IDS.
Regarding claim 9, Brun and Cheng teach the fluid collection assembly of claim 4, wherein the at least one inflatable bladder is spaced from the at least one opening. The examiner notes that while, in an inflated state, at least a portion of the inflatable bladder extends past the funnel body and is thus interpreted to be spaced apart from the at least one opening (see Brun figure 10).
However, should applicant disagree with the interpretation, the examiner brings in prior art reference Harvie. Harvie teaches a fluid collection assembly and is thus considered analogous to the claimed invention. Harvie teaches a male collection configuration (see figure 4,5) where said structure has an opening for a male member. Further, although not detailed in this embodiment, Harvie discloses an inflatable cushion tubing (44 see figure 1A,1B) seen to be around the edge of the collection device. While this is a female collection pad, Harvie states per para. 0114 that “While not depicted, one ordinarily skilled in the art could apply this inflatable design to a cup designed to accommodate a male user and based upon the teaching of this invention such a male embodiment would be obvious.” The examiner interprets this cup to be the cup of figure 4. The examiner notes that as the inflation structure of figure 1A extends around the outermost edge of the collection device, applying said inflation component to the cup of figures 4 and 5 would reasonably place it around the edge of the device as well. Therefore, as the opening of the device is away from the edge (Where the inflation component would be), it is interpreted that the inflation component is spaced from the opening. Therefore, as Harvie teaches a fluid collection cup in which an opening for a male member is provided separately from an inflation component, it would therefore have been obvious to one having ordinary skill in the art to modify a male collection device of Brun to have a smaller central opening, spaced apart from the side edges containing an inflation component as Harvie teaches that such construction is suitable in the art for use in collecting urine from a user. As such, doing so would merely require the simple substitution of one known element for another to obtain predictable results that being the collection of urine from a male user, and thus a prima facie case of obviousness exists.
Regarding claim 24, Brun discloses a system, comprising: a fluid collection assembly including: a fluid impermeable barrier defining a chamber (para. 0049, where the funnel wall is non-absorbent and the interior of the wall is interpreted as a chamber), at least one opening (1), and at least one fluid outlet (20); and at least one inflatable bladder configurable between a first state and at least a second state(ring (5) para. 0041, where a first state is not inflated and the second state is inflated, see also para. 0050); wherein the fluid impermeable barrier exhibits a first dimension measured when the at least one inflatable bladder exhibits the first state and a second dimension when the at least one inflatable bladder exhibits the second state, the first dimension less than the second dimension, the first dimension and the second dimension are a width measured perpendicular to a longitudinal axis of the fluid collection assembly or a length measured parallel to the longitudinal axis (para. 0041, 0051). The examiner notes that as the ring, understood to be an inflatable member, is on an external surface of the collection device, and would expand upon inflation, where the expansion would increase the dimensions of the inflatable member in both a parallel and perpendicular direction to a longitudinal axis, Brun is interpreted to read to the claimed invention. As the member fills with air and since it is rounded in shape, it is interpreted that air would push all sides of the flexible ring outward thus increasing both a width and length of the collection device. As seen in figure 9 and 10, the ring extends past the funnel and thus lends itself to this interpretation.
Further, the examiner notes per para. 0047, the funnel shape may be made to accommodate a urethra configuration, where the device provides a seal against the user. As such it is interpreted as being disposed adjacent to a urethra opening of an individual, switching the at least one inflatable bladder between the first state and at least the second state causes the fluid collection assembly to better conform to one or more anatomical features of the individual.
Brun however, fails to teach at least one porous material at least partially disposed of in the chamber. The drainage tube (20) of Brun may be a tube or connect to other fluid collection devices (para. 0039).
Cheng teaches a urine collection device, and it thus considered analogous to the claimed invention. Cheng teaches external collection devices where figure 2B depicts a wicking spacer element (260) including tube wicking spacer (106) to aid in flow out of the sheath to a further collection component (para. 0036). Figure 2B depicts this configuration for a male collection device, where figure 4B depicts this with a female collection device. The spacer may be a porous material (para. 0123) Therefore, as Cheng teaches that both male and female external collection devices may comprise porous wicking spacer members for directing fluid from a collection interface to a further container, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a porous wicking member within the collection interface of Brun to aid in fluid removal from the interface. Doing so would merely require combining prior art elements according to known methods to yield predictable results, that being the collection and transport of urine, and thus a prima facie case of obviousness exists.
The combination of arts fail to teach a fluid storage container; and a vacuum source; wherein the at least one fluid outlet of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other. However, Brun does teach that the drain (20) can be connection to an appropriate storage/disposal device (para. 0039).
Harvie teaches a urine collection device and is thus considered analogous to the claimed invention. Harvie teaches a male collection cup connected via tubing (13) to a suction control unit (1) including a suction pump (2), where the suction unit is further connected to a collection bag (3). The examiner notes therefore, as Harvie teaches a urine collection system may include a suction pump and storage bag in communication with a user interface, where Brun teaches that the outlet may connect to a suitable storage means, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to connect the device of Brun with a suction unit and bag as a suitable means to remove and store urine. Doing so would merely require combining prior art elements according to known methods to yield predictable results, that being the removal and storage of urine, and thus a prima facie case of obviousness exists.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brun and Cheng in view of Boukidjian et al. US 2020/0030595, hereafter Boukidjian, provided in the IDS.
Regarding claim 13, Brun and Cheng teach the fluid collection assembly of claim 12, wherein one of the first inflatable bladder or the second inflatable bladder includes at least one valve.
Boukidjian teaches a urine drainage system and is thus considered analogous to the claimed invention. Boukidjian further teaches the use of an inflation component where a tube with an inflation lumen connects to said inflation component to inflate the component with a fluid (Para. 0043, 0045). Further, Boukidjian teaches that in the art, indwelling catheters comprises an inflation components and inflation lumens as detailed above, where the inflation lumens have a valve that allows for fluid inflation (Para. 0004). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use inflation fluid to inflate the inflatable components of Brun through a valve, as doing so is known in the art as a means to inflate balloons in urine collection devices. As such, doing so would merely require combining prior art elements according to known methods to yield predictable results, that being the inflation of an inflatable component, and thus a prima facie case of obviousness exists.
Regarding claim 14, Brun and Cheng teach the fluid collection assembly of claim 12, but fails to teach wherein each of the first inflatable bladder and the second inflatable bladder includes at least one valve.
Boukidjian teaches a urine drainage system and is thus considered analogous to the claimed invention. Boukidjian further teaches the use of an inflation component where a tube with an inflation lumen connects to said inflation component to inflate the component with a fluid (Para. 0043, 0045). Further, Boukidjian teaches that in the art, indwelling catheters comprises an inflation components and inflation lumens as detailed above, where the inflation lumens have a valve that allows for fluid inflation (Para. 0004). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use inflation fluid to inflate the inflatable components of Brun through a valve, as doing so is known in the art as a means to inflate balloons in urine collection devices. As such, doing so would merely require combining prior art elements according to known methods to yield predictable results, that being the inflation of an inflatable component, and thus a prima facie case of obviousness exists.
Regarding claim 22, Brun and Cheng teach the fluid collection assembly of claim 2, further comprising a conduit configured to have one or more bodily fluids flow therein (conduit 20 of Brun), but fails to teach the inflatable bladder including at least one valve and the at least one valve is spaced from and not in fluid communication with the conduit. Brun teach the conduit is distinct from the inflatable ring as seen in figure 1.
Boukidjian teaches a urine drainage system and is thus considered analogous to the claimed invention. Boukidjian further teaches the use of an inflation component where a tube with an inflation lumen connects to said inflation component to inflate the component with a fluid (Para. 0043, 0045). Further, Boukidjian teaches that in the art, indwelling catheters comprises an inflation components and inflation lumens as detailed above, where the inflation lumens have a valve that allows for fluid inflation (Para. 0004). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use inflation fluid to inflate the inflatable components of Brun through a valve, as doing so is known in the art as a means to inflate balloons in urine collection devices. As such, doing so would merely require combining prior art elements according to known methods to yield predictable results, that being the inflation of an inflatable component, and thus a prima facie case of obviousness exists.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2,-20,23-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim1-22 of U.S. Patent No. 12251333, hereafter '333. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant application claim number
Corresponding claim of ‘333
2
1,12
3
1,12
4
4
5
12
6
1,9,12
7
1,12
8
1,6
9
1,6,21
10
1,12
11
1
12
1,12
13
1,12
14
1,12
15
12
16
12
17
13
18
1,12
19
17
20
18
21
22
23
15
24
19
25
20
Claim21,22 rejected on the ground of nonstatutory double patenting as being unpatentable over claim1,12 of U.S. Patent No. '333 in view of Brun.
‘333 teaches an outlet but not specifically a conduit separate from the bladder. Brun teaches a fluid collection device, where the outlet comprises a section (20) for fluid leaving the device, where (20) is interpreted as a conduit. Therefore it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to include a separate conduit as an outlet of the device of ‘333 to allow fluid to leave the device. As claim 12 of ‘333 teaches the valves, where the valves are separate from an outlet conduit, ‘333 in view of Brun reads to claim 21 and 22 under obviousness type double patenting.
Claims 2-6,9-17,19,21-22,24-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim1-22 of U.S. Patent No. 12048643, hereafter '643. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant application claim number
Corresponding claim of ‘643
2
1
3
1
4
2
5
11
6
12
7
8
9
3,6
10
6
11
11
12
7
13
1
14
1
15
8
16
1
17
1
18
19
6
20
21
1
22
1
23
24
13
25
1,12
The examiner notes that claims 7-8,18,20,23 are not subject to double patenting in view of ‘643. The device of ‘643 has internal bladders and thus the bladders are not on an exterior surface of the device per the instant claims. Further, it would not be obvious to one having ordinary skill in the art to modify the bladders of ‘643 to be external, nor add additional bladders externally, absent hindsight, to serve the same purpose as the internal bladder.
Claim 2-23 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-21 of copending Application No. 18758025, hereafter '025 (reference application). The examiner notes that although ‘025 has a pending notice of allowance, no patent number has been assigned. Although the claims at issue are not identical, they are not patentably distinct from each other because
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant application claim number
Corresponding claim of ‘025
2
1
3
14
4
8
5
13,14
6
14
7
8
8
8
9
4
10
3
11
14
12
7
13
2
14
2
15
7
16
1
17
1
18
3
19
9
20
1
21
19
22
19
23
2
24
25
Claim 24 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. '025 in view of Harvie.
Harvie teaches a male collection cup connected via tubing (13) to a suction control unit (1) including a suction pump (2), where the suction unit is further connected to a collection bag (3). The examiner notes therefore, as Harvie teaches a urine collection system may include a suction pump and storage bag in communication with a user interface, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to connect the device of ‘025 with a suction unit and bag as a suitable means to remove and store urine. Doing so would merely require combining prior art elements according to known methods to yield predictable results, that being the removal and storage of urine, and thus a prima facie case of obviousness exists. This is a provisional nonstatutory double patenting rejection.
Claim25 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. '025 in view of Brun.
This is a provisional nonstatutory double patenting rejection.
Regarding claim 24, the only distinction is that instant claim 25 requires a method step of attaching to a user adjacent a urethra. The examiner notes that as ‘025 is a urine collection device configured to be used about a user’s urethra, employing the device would require a step of positioning it appropriately . Brun, as provided above teaches this. Therefore, as Brun teaches a urine collection device positioned about a urethra (para. 0020), it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to position the device of ‘025 about a urethra.
Conclusion
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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