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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: length adjusting feature in claim 1-14,17-20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
The examiner notes that per the claims, there is not sufficient structure for a length
adjusting feature. Sufficient structure for the length adjusting feature is provided in the specification of
the instant application (Paragraph 0067). Said structures include a slit, perforations, a point of weakness, a flexible material, or a combination of said emboidments.
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) 1-8, 13-15,18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klug US 5078707, hereafter Klug, and further in view of Cheng et al, US 2004/0006321, hereafter Cheng, where Klug is provided in the IDS
Regarding claim 1, Klug discloses a fluid collection assembly, comprising: a distal region; at least one proximal end region spaced from the distal region; a plurality of intermediate portions extending from the at least one proximal end region to the distal end region, the plurality of intermediate portions configured to be lie substantially flat when completely flared (figure 4, 5); a plurality of length adjusting features extending from the at least one proximal end region towards the distal region, the plurality of length adjusting features configured to allow a length of the fluid collection assembly to change, the plurality of length adjusting features separating the plurality of intermediate portions from each other (See annotated figure of Klug below); The examiner notes that the device of Klug comprises flaps with flap members (Fig. 1,3 (15)), where flap members form a slit when separated. Said slit is interpreted as the length adjusting feature (Klug Fig. 4 (See annotated figured below)). The examiner also notes that per the 112(f) interpretation, a slit is sufficient structure for the length adjusting feature (Para. 0027). The examiner further notes that as seen in figure 3, there is a slit on each side of the device and thus a plurality of length adjusting features are present. Further the examiner notes that as seen in figure 4 and 5, the intermediate portions, in comparison to the rest of the device are flat when flared. The examiner notes that although a completely flared position is not explicitly shown in the figures, one having ordinary skill in the art would find that if the slits were further flared, the intermediate portions would be substantially flat.
Klug further discloses a fluid impermeable barrier forming at least a portion of the distal region, the at least one proximal end region, and the plurality of intermediate portions, the fluid impermeable barrier at least defining a chamber, an opening at the proximal end region, and a fluid outlet (Column 3,
lines 21-29, outlet (Fig. 1, 18)). The examiner notes that per this citation, the device, when in use, the cylindrical sheath (11, Fig. 3) provides a fluid tight seal to prevent the leakage of urine. It is therefore interpreted that the device is formed of a fluid impermeable barrier, where said barrier makes up a portion of the proximal, distal, and intermediate portions. Further, per the same citation, as the device is configured to fit a user's penis within, it is interpreted that the device comprises a chamber formed by said impermeable barrier (Also see figures 1,2,5). As see in figure 2, there is an opening at the proximal end for a penis (26) to be placed into the device, and as further seen in figure 2, an outlet (18) at the distal end of the device
Klug however, does not disclose at least one porous material disposed within the chamber, the at least one porous material configured to receive bodily fluids and move the bodily fluids towards the fluid outlet. Klug does teach, per column 2, line 63-66, that the outlet 18 may be connected to an appropriate urine receptacle.
Cheng teaches a urine collection device and is thus considered analogous to the claimed invention. Cheng teaches that the device comprises a collection component (20 in figure 2a), where said component is connected to storage device (30), through a conveyance tube (10). The conveyance tube comprises a tube wicking spacer (106) configured to guide fluid from the portion attached to the penis toward the storage device (para. 0210,0212). Said tube wicking component is connected with a wicking spacer element (260), seen to extend into the collection component. Therefore, as Klug teaches a urine collection device with an outlet, where said outlet may connect to a suitable receptacle, and Cheng teaches the connection of receptacle and the urine collection device through a tubing and wicking material to better move fluid through the device, 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 the wicking material, tubing, and receptacle of Cheng with the collection device of Klug. Doing so would merely require Combining prior art elements according to known methods to yield predictable results, that being the collection and transfer of urine, and thus a prima facie case of obviousness exists.
PNG
media_image1.png
610
492
media_image1.png
Greyscale
Regarding claim 2, Klug and Cheng teach the fluid collection assembly of claim 1, wherein the distal region is a sump. The examiner notes that a fluid travels toward the distal end and then is required to be wicked away through an outlet tube, the distal end is interpreted to function as a sump.
Regarding claim 3, Klug and Cheng teach the fluid collection assembly of claim 2, wherein the distal region forms a bulge when the plurality of intermediate portions are completely flared. The examiner notes that per Klug, column 2, lines 63-66, the distal end region is conical, and thus forms a bulge. When the length adjusting features are flared, as seen in figure 4 and 5, the conical shape of the distal end remains, and thus the bulge exists when the length adjusting features are flared.
Regarding claim 4, Klug and Cheng teach the fluid collection assembly of claim 1, wherein the plurality of intermediate portions includes a first intermediate portion and a second intermediate portion, and wherein the first intermediate portion exhibits a first length and the second intermediate portion exhibits a second length, the first length and the second length measured from the distal region, the first length less than the second length. The examiner notes that the intermediate portions of Klug are interpreted to be the portions in which the adhesive (24) is contained. As seen in figure 4 of Klug, the right intermediate portion extends further toward the outlet (18) than the left intermediate portion. As such it is interpreted that the left (first) intermediate portion’s length is less than the right (second) intermediate portion’s length and thus reads to the claimed limitation.
Regarding claim 5, Klug and Cheng teach the fluid collection assembly of claim 4, wherein the plurality of intermediate portions only include the first intermediate portion and the second intermediate portion. The examiner notes that as seen in the annotated figure of Klug under the rejection of claim 1, there are two intermediate portions.
Regarding claim 6, Klug and Cheng teach the fluid collection assembly of claim 5, wherein the first intermediate portion defines a cutout that is configured to receive at least a portion of a penis, the cutout extending completely through a thickness of the first intermediate portion (See figures 4 and 5 of Klug, where the penis is placed through a “cutout” in the intermediate portion).
Regarding claim 7, Klug and Cheng teach the fluid collection assembly of claim 6, wherein the cutout extending from the at least one proximal end region of the first intermediate portion partially towards the distal region. The examiner notes that as seen in figure 4 and 5 of Klug, the defined cutout (in which the penis is placed), runs the entire length of the device.
Regarding claim 8, Klug and Cheng teach the fluid collection assembly of claim 1, wherein one of the plurality of intermediate portions defines a cutout that is configured to receive at least a portion of a penis, the cutout extending completely through a thickness of the one of the plurality of intermediate portions. (See figures 4 and 5 of Klug, where the penis is placed through a “cutout” in the intermediate portion, where the defined cutout (in which the penis is placed), runs the entire length of the device).
Regarding claim 13, Klug and Cheng teach the fluid collection assembly of claim 1, wherein the at least one porous material extends into and across the sump. The examiner notes that as seen in figure 2A of Cheng, found obvious to combine with Klug, the porous material extends within the distal end of a collection component and out through a tube. As the distal end is inteprrted as a sump, where the porous material extends through the sump, the prior art combination reads to the limitation.
Regarding claim 14, Klug and Cheng teach the fluid collection assembly of claim 1, wherein the at least one porous material extends across an inlet of the fluid outlet. The examiner notes that as seen in figure 2A of Cheng, found obvious to combine with Klug, the porous material extends within the distal end of a collection component and out through a tube. As the distal end is interpreted is the outlet, where the porous material extends through the outlet, the prior art combination reads to the limitation.
Regarding claim 15, Klug and Cheng teach the fluid collection assembly of claim 1, wherein the plurality of length adjusting features including a slit. See rejection of claim 1.
Regarding claim 18, Klug discloses a method of using a fluid collection assembly, the method comprising: providing the fluid collection assembly, the fluid collection assembly including: a distal region; at least one proximal end region spaced from the distal region; a plurality of intermediate portions extending from the at least one proximal end region to the distal end region, the plurality of intermediate portions configured to be lie substantially flat when completely flared (see figure 4,5); a plurality of length adjusting features extending from the at least one proximal end region towards the distal region, the plurality of length adjusting features configured to allow a length of the fluid collection assembly to change, the plurality of length adjusting features separating the plurality of intermediate portions from each other(See annotated figure of Klug below). The examiner notes that the device of Klug comprises flaps with flap members (Fig. 1,3 (15)), where flap members form a slit when separated. Said slit is interpreted as the length adjusting feature (Klug Fig. 4 (See annotated figured below)). The examiner also notes that per the 112(f) interpretation, a slit is sufficient structure for the length adjusting feature (Para. 0027). The examiner further notes that as seen in figure 3, there is a slit on each side of the device and thus a plurality of length adjusting features are present. Further the examiner notes that as seen in figure 4 and 5, the intermediate portions, in comparison to the rest of the device are flat when flared. The examiner notes that although a completely flared position is not explicitly shown in the figures, one having ordinary skill in the art would find that if the slits were further flared, the intermediate portions would be substantially flat.
Klug further discloses a fluid impermeable barrier forming at least a portion of the distal region, the at least one proximal end region, and the plurality of intermediate portions, the fluid impermeable barrier at least defining a chamber, an opening at the proximal end region, and a fluid outlet(Column 3,
lines 21-29, outlet (Fig. 1, 18)). The examiner notes that per this citation, the device, when in use, the cylindrical sheath (11, Fig. 3) provides a fluid tight seal to prevent the leakage of urine. It is therefore interpreted that the device is formed of a fluid impermeable barrier, where said barrier makes up a portion of the proximal, distal, and intermediate portions. Further, per the same citation, as the device is configured to fit a user's penis within, it is interpreted that the device comprises a chamber formed by said impermeable barrier (Also see figures 1,2,5). As see in figure 2, there is an opening at the proximal end for a penis (26) to be placed into the device, and as further seen in figure 2, an outlet (18) at the distal end of the device. Klug discloses partially flaring at least one of the plurality of intermediate portions and positioning a penis of an individual in the chamber, as seen in figures 4 and 5.
Klug however, does not disclose at least one porous material disposed in the chamber, the at least one porous material configured to receive bodily fluids and move the bodily fluids towards the fluid outlet;
Klug does teach, per column 2, line 63-66, that the outlet 18 may be connected to an appropriate urine receptacle.
Cheng teaches a urine collection device and is thus considered analogous to the claimed invention. Cheng teaches that the device comprises a collection component (20 in figure 2a), where said component is connected to storage device (30), through a conveyance tube (10). The conveyance tube comprises a tube wicking spacer (106) configured to guide fluid from the portion attached to the penis toward the storage device (para. 0210,0212). Said tube wicking component is connected with a wicking spacer element (260), seen to extend into the collection component. Therefore, as Klug teaches a urine collection device with an outlet, where said outlet may connect to a suitable receptacle, and Cheng teaches the connection of receptacle and the urine collection device through a tubing and wicking material to better move fluid through the device, 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 the wicking material, tubing, and receptacle of Cheng with the collection device of Klug. Doing so would merely require Combining prior art elements according to known methods to yield predictable results, that being the collection and transfer of urine, and thus a prima facie case of obviousness exists.
PNG
media_image2.png
610
492
media_image2.png
Greyscale
Regarding claim 19, Klug and Cheng teach the method of claim 18, wherein positioning a penis of an individual in the chamber includes positioning the penis in a cutout defined by one of the plurality of intermediate portions, the cutout extending completely through a thickness of the one of the plurality of intermediate portions (See figure 4,5 of Klug, where the penis is positioned in a cutout portion seen extending through the intermediate portion).
Regarding claim 20, Klug and Cheng teach the method of claim 19, wherein positioning the penis in a cutout includes positioning the one of the plurality of intermediate portions adjacent to one side of the penis (see figure 4,5 of Klug); and further comprising positioning another one of the plurality of intermediate portions adjacent to an opposing side of the penis (see figure 4,5 of Klug).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klug and Cheng and further in view of Leuckel US 2020/0129322, hereafter Leuckel.
Regarding claim 16, Klug and Cheng teach the fluid collection assembly of claim 1, but fails to teach wherein the plurality of length adjusting features including a plurality of perforations.
Leuckel teaches a male urinary flow directing device and is thus considered analogous to the
claimed invention. Leuckel further teaches a means of changing the size of the device via a tearable perforation line (Fig. 2A-2C, 3A,3B, perforation line (120)). The changing in size of the device via the
tearing of the perforation is seen in figures 3A and 3B. The examiner notes that as detailed under the
rejection of claim 1, the flaps of the device of Klug and Davis form the slits, interpreted as the length
adjusting features of the claim (Detailed under the rejection of claim 1). Said flaps, as seen in figure 2 of
Klug start connected and then are separated to then fit the user (Fig. 4). 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
a tearable perforation line as a means for separating the flaps to form the slit (length adjusting feature)
of the combination Klug and Cheng, as doing so is known in the art to make such urine collection device able to fit users of different sizes. Said perforation line would be part of the flaps and therefore the slit, and therefore it is interpreted as the length adjusting feature comprises a plurality of
perforations. Thus, doing so would merely require the simple substitution of one known element for another to obtain predictable results, that being the adjustment of length of a urine collection device, and thus a prima facie case of obviousness exists.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klug and Cheng and further in view of Davis et al. US 2018/0228642, hereafter Davis, provided in the IDS.
Regarding claim 17, Klug discloses a fluid collection system, comprising: a fluid collection assembly including: a distal region; at least one proximal end region spaced from the distal region; a plurality of intermediate portions extending from the at least one proximal end region to the distal end region, the plurality of intermediate portions configured to be lie substantially flat when completely flared (see figure 4,5); a plurality of length adjusting features extending from the at least one proximal end region towards the distal region, the plurality of length adjusting features configured to allow a length of the fluid collection assembly to change, the plurality of length adjusting features separating the plurality of intermediate portions from each other (See annotated figure of Klug below); The examiner notes that the device of Klug comprises flaps with flap members (Fig. 1,3 (15)), where flap members form a slit when separated. Said slit is interpreted as the length adjusting feature (Klug Fig. 4 (See annotated figured below)). The examiner also notes that per the 112(f) interpretation, a slit is sufficient structure for the length adjusting feature (Para. 0027). The examiner further notes that as seen in figure 3, there is a slit on each side of the device and thus a plurality of length adjusting features are present. Further the examiner notes that as seen in figure 4 and 5, the intermediate portions, in comparison to the rest of the device are flat when flared. The examiner notes that although a completely flared position is not explicitly shown in the figures, one having ordinary skill in the art would find that if the slits were further flared, the intermediate portions would be substantially flat.
Klug further discloses a fluid impermeable barrier forming at least a portion of the distal region, the at least one proximal end region, and the plurality of intermediate portions, the fluid impermeable barrier at least defining a chamber, an opening at the proximal end region, and a fluid outlet (Column 3,
lines 21-29, outlet (Fig. 1, 18)). The examiner notes that per this citation, the device, when in use, the cylindrical sheath (11, Fig. 3) provides a fluid tight seal to prevent the leakage of urine. It is therefore interpreted that the device is formed of a fluid impermeable barrier, where said barrier makes up a portion of the proximal, distal, and intermediate portions. Further, per the same citation, as the device is configured to fit a user's penis within, it is interpreted that the device comprises a chamber formed by said impermeable barrier (Also see figures 1,2,5). As see in figure 2, there is an opening at the proximal end for a penis (26) to be placed into the device, and as further seen in figure 2, an outlet (18) at the distal end of the device.
Klug however, does not disclose at least one porous material disposed in the chamber, the at least one porous material configured to receive bodily fluids and move the bodily fluids towards the fluid outlet; a fluid storage container configured to hold one or more bodily fluids; a vacuum source fluidly coupled to one or more of the fluid storage container or the fluid collection assembly via a conduit, the vacuum source configured to draw fluid from the fluid collection assembly via the conduit.
Klug does teach, per column 2, line 63-66, that the outlet 18 may be connected to an appropriate urine receptacle.
Cheng teaches a urine collection device and is thus considered analogous to the claimed invention. Cheng teaches that the device comprises a collection component (20 in figure 2a), where said component is connected to storage device (30), through a conveyance tube (10). The conveyance tube comprises a tube wicking spacer (106) configured to guide fluid from the portion attached to the penis toward the storage device (para. 0210,0212). Said tube wicking component is connected with a wicking spacer element (260), seen to extend into the collection component. Therefore, as Klug teaches a urine collection device with an outlet, where said outlet may connect to a suitable receptacle, and Cheng teaches the connection of receptacle and the urine collection device through a tubing and wicking material to better move fluid through the device, 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 the wicking material, tubing, and receptacle of Cheng with the collection device of Klug. Doing so would merely require Combining prior art elements according to known methods to yield predictable results, that being the collection and transfer of urine, and thus a prima facie case of obviousness exists.
Davis teaches a urine collection device and is thus considered analogous to the claimed invention. Davis teaches a tube (32) for aiding in removal of urine from the patient interfacing device (para. 0053). Davis further teaches the use of a vacuum source (figure 32, (210)) and a fluid collection reservoir (204), where the vacuum source provides suction to the device via the tube in order to further aid in the removal of urine from the device (para. 0060). 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 provide the urine collection device of Klug and Cheng with a vacuum source for connecting through the tube to the collection interface, as a means to aid in the removal of urine from the interface. Doing so would merely involve combining prior art elements according to known methods to yield predictable results, that being the removal of urine from a device, and thus a prima facie case of obviousness exists.
PNG
media_image2.png
610
492
media_image2.png
Greyscale
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 1-3,5-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-22 of U.S. Patent No. 12233003, hereafter '003. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant application claim number
Corresponding claim in ‘003
1
1
2
2
3
1,6
4
N/A
5
1,10
6
21
7
21
8
1,21
9
1
10
1
11
1
12
1,21
13
20
14
20
15
6
16
7
17
22
18
n/a
19
n/a
20
n/a
Regarding instant claim 14, as the sump is at the inlet of the opening, and the porous material extends into and across the sump of ‘003, the sump is interpreted to extend across the inlet of the opening.
Claims 4,18-20 are subject to obviousness type double patenting, detailed below.
Claims 4,18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12233003, previously, and hereafter, '003 in view of Klug.
Regarding claim 4, while ‘003 does not specifically teach that the intermediate portions have differing lengths, Klug teaches a urine collection device where the intermediate portions (portions containing adhesive 24) are seen to be different lengths. As seen in figure 4 of Klug, the right intermediate portion extends further toward the outlet (18) than the left intermediate portion. As such it is interpreted that the left (first) intermediate portion’s length is less than the right (second) intermediate portion’s length. 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 device of ‘003 to have differing intermediate part lengths.
Regarding claim 18, while ‘003 does not teach a specific method of using the device, the structural limitations of claim 18 are read to by claim 1 of ‘003. As claim 1 of ‘003 fails to teach the specific steps of partially flaring at least one of the intermediate portions and positioning of a penis of an individual in the chamber, Klug is brought in. Klug teaches a urine collection device including a slit (interpreted as the length adjusting feature), where the slit allows for the device to open and flare and a penis is positioned within the intermediate portion of the device (see figure 4 and 5 of Klug). Therefore it would have been obvious to use flared the slits of ‘003 and place a penis within, as this is the devices intended purpose, and Klug teaches that urine collection devices with slits are used in this manner.
Regarding claim 19 and 20, ‘003 teaches the structural limitations, where in combination with Klug, a penis is positioned with the structure, and thus the claims are read to by ‘003 in view of Klug.
Allowable Subject Matter
Claims 9-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 9, the examiner draws attention to the prior art previously used in the rejection. Cheng was used to teach the porous material in combination with Klug. As seen in figure 2A of Cheng the porous material extends into the collection component and appears to split into a Y-shape. While these are separate portions they are not understood to be slits which would be adjacent to the length adjusting feature, allowing the porous material to split when the length adjust feature is split. Rather they are just elongated portions, that although would be adjacent to at least a portion of the intermediate portion, would not exhibit the same deformation that the length adjusting feature exhibits when flared.
The Davis reference, also used in the rejection teaches a porous material into (see Davis para. 0056), wherein Davis teaches that the collection layers wick fluid away from the body in into the device.
However, Davis does not teach that the porous material comprises a slit. Further it would not have been obvious to simply change the shape or add a slit to Davis as the porous material surrounds a structure of drainage and it configured to be place up against a patient. Therefore it is unclear how the device would function with a slit that extends the length of the material.
Lim US 3788324 teaches a slit in a porous material (see figure 2), Lim does not allow the porous material to receive bodily fluids and move bodily fluids, as the porous material of Lim is covered in an adhesive such that the porous material sticks to the user and holds the device in place forming a liquid tight seal, and as the urine is simply drained through the opening at the bottom. Therefore it cannot be interpreted that the porous material of Lim receives and moves fluid.
While other arts teach porous materials configured to absorb fluid (Lee 2015/0045757), like
Davis it would not be obvious to modify the device to meet the limitations of the claim as Lee does not
extend the length of the device nor have a slit. Likewise Walters (US 2008/0183157) shows a collection
device comprising a slit and a material that may be interpreted as porous due to holes (121) however
said holes are configured to allow air to escape not collect fluid and as such cannot read to the limitation
nor be modified to meet the requirements of said limitation.
Claims 10-12 depend from claim 9 and are thus objected to.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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.
/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
Prosecution Insights