DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant amended claims 1 and 29. Claims 1-4, 6, 11-15, 17-18, 21, 23-24, 26-31, and 33 are currently pending.
Response to Arguments
Applicant’s arguments, see page 6 of Applicant’s Remarks, filed 06/11/26, with respect to the rejections of claims 1-4, 6, 11-15, 17-18, 21, 23-24, 26-31, and 33 under 35 U.S.C. 112(b) as being indefinite have been fully considered and are persuasive in light of the amendments to claims 1 and 29. Therefore, the rejections have been withdrawn.
Applicant’s arguments, see page 7, with respect to the rejections of claims 1, 6, 11-12, and 18 under 35 U.S.C. 102(a)(1) as anticipated by Radl have been fully considered and are persuasive in light of the amendment to independent claim 1. Accordingly, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection have been made as indicated below.
Applicant’s arguments, see pages 7-10, with respect to Radl in view of Davis as applied to amended claim 1 and the rejection of claim 29, and their respective dependent claims, have been fully considered and are not persuasive.
Applicant argues, see pages 7-8, that one of ordinary skill in the art would not combine Radl and Davis to result in the recitation, “during use, the distal end region being positioned to be closer to a gluteal cleft than the proximal end region” because the cap of Davis (Fig. 27C, feat. 28; ¶0081-0083 and 0101) is a simple, passive fluid reservoir including a soft flexible member formed of silicone rubber while collects fluid passively from an external catheter by gravity, while the regulator of Radl (Figs. 2-3, feat. 24; ¶0049) is a rigid, active pressure-regulation mechanism that regulates suction pressure applied to an external catheter for fluid collection. However, suction may also be applied to the cap of Davis to aid with fluid collection from the external catheter (¶0081, lines 12-19), and therefore the cap of Davis corresponds to, or is homologous to, the regulator of Radl.
Applicant further argues, see pages 8-9, that positioning the regulator of Radl in the gluteal cleft would render the device unsuitable for its intended purpose because it relies on an atmospheric reference port which may be susceptible to being blocked or covered by a portion of the user’s body (Figs. 2 and 4, feat. 80; ¶0062). However, as pointed out by applicant, Radl teaches a T-shaped slot or recess (84) which prevents the atmospheric reference port from being blocked by the user’s body by providing multiple slots for atmospheric air to reach the port (¶0062). Applicant further argues that positioning the regulator in the gluteal cleft would cause tissue to be pressed on all sides of the port, even despite the T-shaped recess. However, because T-shaped recess comprises multiple branches, it is highly likely that at least one branch would remain open to the atmosphere and the regulator would continue to function. Applicant further argues that the conduit extending from port 24A on the top wall of the housing body would be compressed or kinked against the bed surface or seat when the patient is lying supine or seated. However, the claims as written do not require the patient to be in any particular position while the fluid collection system is being used.
Applicant further argues, see page 9, that the cap of Davis is secured in the gluteal folds because of its soft, wedge shape that conforms to anatomy (¶0084) and that the PTO has not demonstrated that a rigid housing could be secured in the gluteal cleft or why one or ordinary skill in the art would attempt to fit the regulator into the gluteal cleft. However, the claims as written require that the distal end region of the body of the fluid collection system be positioned closer to the gluteal cleft than the proximal end region, not secured in it, and Davis provides the motivation of aiding with properly positioning the fluid collection system (¶0081).
Applicant further argues, see page 9, that the port of Radl (Fig. 3, feat. 24B), corresponding to the claimed arm connector, is not positioned adjacent to the front side of the body (24) as claimed. However, the port/arm connector (24B) communicates and is continuous with the arm opening (Annotated Fig. 3, feat. A) and arm walls defining the cavity (22C) of the arm (22A), and therefore comprises a portion adjacent the front side of the body.
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.
Claims 1, 6, 11-12, 15, 17-18, 28-30, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Radl et al. (US 2021/0113749 A1) in view of Davis et al. (US 2018/0228642 A1).
Regarding claim 1, Radl discloses a fluid collection system (Figs. 1-3, feat. 10; ¶0048-0049), comprising: a fluid collection assembly (20; ¶0049 and 0052-0053) including: a body (24; ¶0049) including a proximal end region, a distal end region opposite the proximal end region, a front side, and a back side opposite the at least one front side (Annotated Fig. 3); and a connector piece configured to be attached or integrally formed with the body, the connector piece positioned closer to the distal end region of the body than the proximal end region (26; ¶0049 and 0056), the connector piece defining a conduit connector (Fig. 1, feat. 24A; ¶0050) configured to be connected to a conduit (Fig. 1, feat. 18) and an arm connector (24B; ¶0052-0053), the conduit connector positioned adjacent the back side of the body (Annotated Fig. 3, feat. 24A) and the arm connector positioned adjacent to the front side of the body (Annotated Fig. 3, feat. 24B); an arm (Figs. 3 and 7, feat. 22A; ¶0052-0053) including one or more arm walls defining a cavity (22C) and an arm opening (Annotated fig. 3, feat. A) configured to be in fluid communication with the arm connector (24B; ¶0053), the one or more arm walls defining one or more perforations extending therethrough that allows fluids to flow from an exterior of the arm to the cavity (22E and 22F; ¶0052-0053); and at least one porous cartridge configured to be reversibly attached to the fluid collection assembly (22B; ¶0049, 0053, and 0070).
Radl does not disclose that during use, the distal end region is positioned to be closer to a gluteal cleft than the proximal end region and the front side is positioned to face a vaginal region.
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[AltContent: textbox (Annotated Fig. 3: Adapted from Radl to show the directions and the arm opening A.)]Davis teaches a fluid collection device (Figs. 27A-C, feat. 10; ¶0100-0103) comprising a cap (28) through which suction is applied to remove fluid from the fluid collection device (¶0081-0083 and 0101). Therefore, the cap is a homologous structure to the body of Radl (Radl: 24; ¶0049). Davis teaches that the cap should be positioned closer to the gluteal cleft than the opposite side of the device in order to aid with securing the device in position relative to the user (¶0081). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Radl so that during use, the distal end region is positioned to be closer to a gluteal cleft than the proximal end region and the front side is positioned to face a vaginal region in order to aid with securing the device in position relative to the user as taught by Davis.
Regarding claim 6, Radl in view of Davis suggests the system of claim 1, and Radl further discloses that the body (24) or the connector piece (26) defines a sump (Fig. 3, feat. 40; ¶0057) at or near the distal end region thereof, at least a portion of the arm connector (24B) is disposed in the sump (40).
Regarding claim 11, Radl in view of Davis suggests the system of claim 1, and Radl further discloses that the arm (Figs. 2-3, feat. 22A) includes a top side (22E) opposite the arm opening (Annotated Fig. 3, feat. A), and wherein the top side includes the one or more perforations formed therein (22E; ¶0052-0053).
Regarding claim 12, Radl in view of Davis suggests the system of claim 1, and Radl further discloses that the arm exhibits a generally circular cross-sectional shape (Figs. 2-3 and 8, feat. 22A).
Regarding claims 15 and 17, Radl in view of Davis suggests the system of claim 1, and Radl further discloses at least one conduit (Fig. 1, feat. 18) attached or attachable to the conduit connector (Fig. 1, feat. 24A; ¶0050).
Davis further teaches a fluid collection device (Figs. 27A-C, feat. 10; ¶0100-0103) comprising a conduit connector (Fig. 27C, feat. 28; ¶0101) positioned to cause a conduit (32) to extend along or adjacent to the back side of the body of the device (Fig. 27C, feat. 20). The conduit may be retained by a recess defined between the body (Figs. 27A-C, feat. 20) and a hook (Figs. 27A-C, feat. 100; ¶0101). Davis teaches that such a conduit positioning and retention system allows the conduit to be positioned away from the patient as needed and prevents the conduit from being accidentally removed from the conduit connector (¶0101). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Radl in view of Davis so that the at least one conduit extends along or adjacent to at least a portion of the back side of the body when the at least one conduit is attached to the conduit connector, with respect to claim 15, and so that the body defines a recess that is configured to receive and enclose a portion of the at least one conduit, with respect to claim 17, in order to allow the conduit to be positioned away from the patient as needed and to prevent the conduit from being accidentally removed from the conduit connector as taught by Davis.
Regarding claim 18, Radl in view of Davis suggests the system of claim 1, and Radl further discloses that the at least one porous cartridge (Figs. 1-3, feat. 22B) includes at least one porous material defining a hollow region (¶0053, lines 1-14), the hollow region configured to have the arm (22A) disposed therein (¶0053), wherein the at least one porous cartridge and the fluid collection assembly are configured to have the at least one porous cartridge removed from the fluid collection assembly substantially without bending any component of the fluid collection assembly (¶0049, 0053, and 0070).
Regarding claim 28, Radl in view of Davis suggests the system of claim 1, but is silent with respect to at least one shape memory material at least one of disposed in, attached to, or incorporated in the arm.
Davis further teaches a fluid collection device (Figs. 1-7, feat. 10; ¶0052-0056) comprising a porous collection layer (40) and porous collection core (42; ¶0056-0059) disposed around a tube (32) which exerts suction to evacuate fluid from the collection layer and core (¶0060). Therefore, the porous collection layer and core correspond to the porous cartridge of Radl, while the tube corresponds to the arm of Radl. Davis further teaches that the tube may be made of a shape-retaining polyurethane material which advantageously allows the tube to be adjusted into a desired, body conforming shape, and to maintain that shape until it is adjusted again (¶0062-0063). Therefore, the shape-retaining polyurethane tube of Davis incorporates a shape memory material as defined by the present specification (Present specification: ¶0078-0080). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Radl in view of Davis so that it further comprises at least one shape memory material at least one of disposed in, attached to, or incorporated in the arm in order to allow the arm to be adjusted into a body conforming shape such that it maintains that shape as taught by Davis.
Regarding claim 29, Radl discloses a method of using a fluid collection system (¶0024), the method comprising: positioning a first porous cartridge (Figs. 1-3, feat. 22B) adjacent to a urethral opening of an individual (¶0024 and 0049), the first porous cartridge including at least one porous material defining a hollowed region (¶0053, lines 1-14), the first porous cartridge reversibly attached to a fluid collection assembly (20; ¶0049 and 0052-0053), the fluid collection assembly comprising: a body (24; ¶0049) including a proximal end region, a distal end region opposite the proximal end region, a front side generally facing a vaginal region of the individual (¶0049 and 0065), and a back side opposite the one front side (Annotated Fig. 3); a connector piece attached or integrally formed with the body, the connector piece positioned closer to the distal end of the body than the proximal end region (26; ¶0049 and 0056), the connector piece defining a conduit connector (Fig. 1, feat. 24A; ¶0050) configured to be connected to a conduit (Fig. 1, feat. 18) and an arm connector (24B; ¶0052-0053), the conduit connector positioned on the back side of the body (Annotated Fig. 3, feat. 24A) and the arm connector positioned on the front side of the body (Annotated Fig. 3, feat. 24B); and wherein one of the first porous cartridge or the fluid collection assembly includes an arm (Figs. 3 and 7, feat. 22A; ¶0052-0053) including one or more walls defining a cavity (22C) and an opening (Annotated fig. 3, feat. A) that is in fluid communication with the arm connector (24B; ¶0053), the one or more walls defining one or more perforations extending therethrough that allows fluids to flow from an exterior of the arm to the cavity (22E and 22F; ¶0052-0053), at least a portion of the arm disposed in the hollowed region of the first porous cartridge (¶0053); and receiving one or more bodily fluids from the vaginal region of the individual into the at least one porous material of the first porous cartridge (¶0024 and 0049); and flowing at least some of the one or more bodily fluids received into the at least one porous material of the first porous cartridge into the cavity of the arm (¶0049).
Radl is silent with respect to the distal end region being closer to a gluteal cleft of the individual than the proximal end region.
Davis teaches a fluid collection device (Figs. 27A-C, feat. 10; ¶0100-0103) comprising a cap (28) through which suction is applied to remove fluid from the fluid collection device (¶0081-0083 and 0101). Therefore, the cap is a homologous structure to the body of Radl (Radl: 24; ¶0049). Davis teaches that the cap should be positioned closer to the gluteal cleft than the opposite side of the device in order to aid with securing the device in position relative to the user (¶0081). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method disclosed by Radl so that the distal end region is closer to a gluteal cleft of the individual than the proximal end region in order to aid with securing the device in position relative to the user as taught by Davis.
Regarding claim 30, Radl in view of Davis suggests the method of claim 29, and Radl further discloses before positioning the first porous cartridge adjacent to the urethral opening of the individual, reversibly attaching the first porous cartridge to the fluid collection assembly (¶0049 and 0053: suction is applied from the fluid collection assembly 20, through the porous cartridge 22B, and to the urethral opening, and therefore, the cartridge is attached to the fluid collection assembly before being positioned adjacent the urethral opening).
Regarding claim 33, Radl in view of Davis suggests the method of claim 29, and Radl further discloses after receiving one or more bodily fluids from the vaginal region of the individual into the at least one porous material of the first porous cartridge, removing the first porous cartridge from the fluid collection assembly and after removing the first porous cartridge from the fluid collection assembly, reversibly attaching a second porous cartridge to the fluid collection assembly (¶0053 and 0070).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Radl in view of Davis and in further view of Swiecicki et al. (US 2005/0137557 A1).
Regarding claims 2-4, Radl in view of Davis suggests the system of claim 1, and Radl further discloses that the body (20) includes: a central portion (36; ¶0056) attached to or integrally formed with the connector piece (26). Radl in view of Davis does not disclose one or more flanges extending from the central portion, with respect to claim 2, that the one or more flanges includes a bottom flange extending from the central portion, wherein the bottom flange forms the distal end region, with respect to claim 3, or that the one or more flanges form a generally concavely curve relative to the front side of the body, with respect to claim 4.
Swiecicki teaches a urinary incontinence article (Figs. 1-4 and 7A, feat. 20; ¶0027) comprising a flange (Figs. 1-4, feat. 51; ¶0031) extending from a central portion (50) in every direction, including the proximal, distal, and lateral directions (Figs. 1-2). The flange is concavely curved relative to the body-facing side of the article (Figs. 1-4 and 7A, feat. 51; ¶0031 and 0037). Swiecicki teaches that such a flange advantageously rests at least partially outside the labia of the wearer (¶0015 and 0031) and is shaped to coordinate with the natural shape of the wearer’s vaginal, labial, and perineal areas (¶0037), which enables accurate positioning of the article (¶0015). By modifying the body of the system of Radl in view of Davis so that the central portion includes a flange which rests outside the labia of the wearer and is shaped to coordinate with the natural shape of the wearer’s vaginal, labial, and perineal areas as taught by Swiecicki, the modified fluid collection system would be able to be more accurately positioned as taught by Swiecicki. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Radl in view of Davis so that it comprises one or more flanges extending from the central portion, with respect to claim 2, so that the one or more flanges includes a bottom flange extending from the central portion, wherein the bottom flange forms the distal end region, with respect to claim 3, and so that the one or more flanges form a generally concavely curve relative to the front side of the body, with respect to claim 4, so that the system cooperates with the natural curvature of the female wearer’s anatomy and can be accurately positioned as taught by Swiecicki.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Radl in view of Davis and in further view of Perkins et al. (US 2008/0200884 A1).
Regarding claim 13, Radl in view of Davis suggests the system of claim 1, but does not disclose that the arm exhibits a cross-sectional shape exhibiting at least one apex.
Perkins teaches medical tubing (Figs. 2-3, feat. 14; ¶0013) comprising reinforcement structures which give the cross-section of the tubing multiple apices (Fig. 2, feat. 22). Perkins teaches that such reinforcement structures make the tubing resistant to bending and kinking (¶0006 and 0013). The arm disclosed by Radl is suction tubing (Radl: Fig. 3, feat. 22A; ¶0049), and modifying it to have multiple apices like the tubing taught by Perkins would make it resistant to bending and kinking as taught by Perkins. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Radl in view of Davis so that the arm exhibits a cross-sectional shape exhibiting at least one apex in order to make it resistant to bending and kinking as taught by Perkins.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Radl in view of Davis and in further view of Orr et al. (WO 2019/038732 A1).
Regarding claim 14, Radl in view of Davis suggests the system of claim 1, but does not disclose that a surface area density of the one or more perforations is greater at or near a top side of the arm than at or near the arm opening.
Orr teaches a ureteral catheter (Figs. 27, 29, and 30A-E, feat. 1212; ¶00167) comprising a tubular body (1222) with a retaining drainage end (1220, 1230; ¶00170-0173) with drainage perforations (1232) and an opposing suction end (1228; ¶00169) to which a suction pump (2000) is connected to apply suction to the catheter to draw urine through the catheter (¶00172-00173). In the system of Radl in view of Davis, suction is applied from the conduit connector (Radl: Annotated Fig. 3, feat. 24A) to the arm opening (Radl: A), to the cavity (Radl: 22C) of the arm (Radl: 22A) and through the one or more perforations in the arm (Radl: 22E and 22F; ¶0052-0053), and therefore the drainage perforations of Orr are analogous to the arm perforations of Radl. Orr teaches that the drainage perforations may be sized and spaced so that a total area of the perforations is larger further away from the source of suction in order to improve the flow distribution through the lumen of the catheter relative to uniformly sized drainage perforations (Fig. 30E, feat. 1232; Figs. 31-34; ¶00173 and 00180-00186). By modifying the system of Radl in view of Davis so that the perforations in the arm are sized and spaced so that a total area of the perforations is larger further away from the arm opening, which is the source of suction in the arm, the flow distribution through the arm would be improved as taught by Orr. Therefore, it would have been prima face obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Radl in view of Davis so that a surface area density of the one or more perforations is greater at or near a top side of the arm than at or near the arm opening in order to improve the flow distribution through the arm as taught by Orr.
Claims 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Radl in view of Davis and in further view of Zaltsberg et al. (US 2014/0230831 A1).
Regarding claim 21, Radl in view of Davis suggests the system of claim 18, but does not disclose that the at least one porous cartridge includes an upper region and a bottom region, the upper region exhibiting a lateral dimension that is greater than the bottom region.
Zaltsberg teaches a panty guard (Fig. 3, feat. 300; ¶0028) comprising fluid absorbent material (¶0030-0031) with a fluid absorbent apex portion (360, 366; ¶0032-0034 and 0044). The panty guard may be trapezoidal with a laterally wider anterior end (Fig. 3, feat. 330; ¶0029) and narrow posterior end (340) and the apex portion may also include a wider central portion and narrow posterior end (364; ¶0033-0034). Zaltsberg teaches that such a configuration advantageously provides support to the wearer’s pelvic floor (¶0032). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Radl in view of Davis so that the at least one porous cartridge includes an upper region and a bottom region, the upper region exhibiting a lateral dimension that is greater than the bottom region in order to provide support to the user’s pelvic floor as taught by Zaltsberg.
Regarding claim 23, Radl in view of Davis suggests the system of claim 18, but does not disclose that the at least one porous cartridge exhibits a cross-section shape exhibiting an apex.
Zaltsberg teaches a panty guard (Fig. 3, feat. 300; ¶0028) comprising an apex portion (360, 366; ¶0032-0034 and 0044) which advantageously provides support to the wearer’s pelvic floor (¶0032). Zaltsberg further teaches that the panty guard and apex portion are fluid absorbent (¶0030-0031 and 0037). In the fluid collection system of Radl in view of Davis, the absorbent, porous cartridge (Radl: Fig. 3, feat. 22B) is positioned against the urethra of the user (Radl: ¶0049), and therefore near the pelvic region of the user. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Radl in view of Davis so that the at least one porous cartridge exhibits a cross-section shape exhibiting an apex in order to provide support to the user’s pelvic floor as taught by Zaltsberg.
Claims 24 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Radl in view of Davis and in further view of Bubb et al. (US 2006/0079852 A1).
Regarding claim 24, Radl in view of Davis suggests the system of claim 18, and Radl further discloses that the at least one porous cartridge includes a plurality of porous cartridges (¶0070). Radl in view of Davis does not disclose that at least some of the plurality of porous cartridges exhibits at least one of different lateral dimensions or different lengths.
Bubb teaches a negative-pressure wound treatment system (Fig. 1, feat. 2; ¶0083) with a fluid drainage and collection system (Figs. 5-12g) comprising a primary fluid transfer component (Figs. 5-6 and 10, feat. FTC.1; ¶0084 and 0090), a secondary fluid transfer component comprising a porous, absorbent sponge (Figs. 7-11c, feat. FTC.2; ¶0084 and 0091-0095), and a tertiary fluid transfer component (Figs. 9-12d, feat. FTC.3; ¶0092-0093 and 0096) comprising a vacuum drain tube (Fig. 9, feat. 60; ¶0092). Bubb teaches that the primary and secondary fluid transfer components, which includes the porous sponge, may be prepackaged in different sizes and configurations for application to different patient conditions (¶0095). By modifying the system of Radl in view of Davis so that the plurality of porous, absorbent cartridges (Radl: Fig. 3, feat. 22B) are prepackaged in different sizes and configurations, the system could be used for different patient conditions as taught by Bubb. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Radl in view of Davis so that at least some of the plurality of porous cartridges exhibits at least one of different lateral dimensions or different lengths so that the system may be used for different patient conditions as taught by Bubb.
Regarding claim 31, Radl in view of Davis suggests the method of claim 30, but does not disclose before reversibly attaching the first porous cartridge to the fluid collection assembly, selecting the first porous cartridge from a plurality of porous cartridges, wherein at least some of the plurality of porous cartridges exhibit at least one of different lateral dimensions or different lengths.
As discussed above, Bubb teaches a negative-pressure wound treatment system (Fig. 1, feat. 2; ¶0083) with a fluid drainage and collection system (Figs. 5-12g) comprising a primary fluid transfer component (Figs. 5-6 and 10, feat. FTC.1; ¶0084 and 0090), a secondary fluid transfer component comprising a porous, absorbent sponge (Figs. 7-11c, feat. FTC.2; ¶0084 and 0091-0095), and a tertiary fluid transfer component (Figs. 9-12d, feat. FTC.3; ¶0092-0093 and 0096) comprising a vacuum drain tube (Fig. 9, feat. 60; ¶0092). Bubb teaches that the primary and secondary fluid transfer components, which includes the porous sponge, may be prepackaged in different sizes and configurations for application to different patient conditions, with particular fluid transfer component size or configurations being used for particular patient conditions (¶0095). By modifying the method suggested by Radl in view of Davis so that the plurality of porous, absorbent cartridges (Radl: Fig. 3, feat. 22B) are prepackaged in different sizes and configurations, and particular cartridges are chosen for particular conditions, the method could be used for different patient conditions as taught by Bubb. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method suggested by Radl in view of Davis so that before reversibly attaching the first porous cartridge to the fluid collection assembly, selecting the first porous cartridge from a plurality of porous cartridges, wherein at least some of the plurality of porous cartridges exhibit at least one of different lateral dimensions or different lengths so that the method may be used for different patient conditions as taught by Bubb.
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Radl in view of Davis and in further view of Yong et al. (WO 2005/003725 A2).
Regarding claims 26-27, Radl in view of Davis suggests the system of claim 18, but does not disclose one or more anchors configured to secure the at least on porous material to the fluid collection assembly, with respect to claim 26, or that the one or more anchors includes at least one first anchor attached to the fluid collection assembly and at least one second anchor attached to or at least partially disposed in the at least one porous cartridge, the at least one first anchor including a T-track defining a channel and the at least one second anchor includes a shaft and a head, the head configured to be disposed in and slide along the channel.
Yong teaches a fluid collection device (Figs. 1-4, feat. 100; Page 11, line 20 – Page 12, line 8; Page 23, line 31 – Page 25, line 5) comprising a liquid receiving device (Fig. 1, feat. 102; Page 24, lines 6-22) secured to a handle (Fig. 3, feat. 110; Page 24, line 23 – Page 25, line 5) via a T-slot or T-Track defining a channel on the handle (Figs. 1 and 3, feat. 118) which slidingly receives a body-fitting comprising a shaft and a head (Figs. 1 and 4, feat. 112). Yong teaches that this allows the liquid receiving device to be detachably mounted to the handle at an ergonomically convenient angle (Page 11, line 28 – Page 12, line 8; Page 24, line 23 – Page 25, line 5). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Radl in view of Davis so that it further comprises one or more anchors configured to secure the at least on porous material to the fluid collection assembly, with respect to claim 26, and so that the one or more anchors includes at least one first anchor attached to the fluid collection assembly and at least one second anchor attached to or at least partially disposed in the at least one porous cartridge, the at least one first anchor including a T-track defining a channel and the at least one second anchor includes a shaft and a head, the head configured to be disposed in and slide along the channel in order to detachably mount the porous cartridge to the fluid collection assembly at an ergonomically convenient angle as taught by Yong.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 5712727159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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