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
Claims 1, 3-7, and 13-19 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 5-9 of Applicant’s Remarks, filed 09/30/25, with respect to the rejections of claims 1, 3-6, 13, and 17-19 under 35 U.S.C. 103 as being unpatentable over Kubalak in view of O’Flynn, in further view of Clark, and in further view of Hartig, of claim 7 in further view of Svensson, and of claims 14-16 in further view of Fletter have been fully considered and are not persuasive.
Applicant argues that Hartig is non-analogous art and cannot be relied upon in an obviousness analysis because Hartig is from a different field of endeavor from the claimed invention and is not reasonably pertinent to the problems faced by the inventors of the claimed subject matter.
While Hartig teaches the construction of strong, light-weight structures, and is therefore not from the same field of endeavor as the claimed invention, Hartig is reasonably pertinent to the problems faced by the inventors of the claimed subject matter. Applicant argues that Hartig is not pertinent to the problem of providing a toilet-flushable urinary catheter whose structure and materials are conducive to degrading in water. While this problem is explicitly described in the present specification, it is not the only problem faced by the inventors of the claimed subject matter. Problems which are implied by the specification to have been faced by the inventor also qualify prior art as being analogous. Please see MPEP §2141.01(a)(I). The present specification also describes the catheters as being for use by those facing catheter drainage issues such as wheelchair bound users (¶0001), describes the use of packed catheters (¶0002), and describes the catheters as being used by users performing the catheterization procedure on themselves (¶0003). These aspects of the invention imply additional problems faced by the inventor regarding the catheter and its accessories being durable enough to stay intact during packaging, transport, and handling by the user. Therefore, the construction of strong, light-weight structures, as taught by Hartig, is reasonably pertinent to the problems faced by the inventor as implied in the specification.
Claim Interpretation
Claim 7 recites that the water flushable material is made from “raw pasta”. ¶0018 of the specification discloses the use of “uncooked, raw pasta” and provides “macaroni and noodle products” as examples of raw pasta, but does not otherwise provide a special definition of “raw pasta” as a material. Cambridge dictionary defines “pasta” as “a food made from flour, water, and sometimes egg, that is cooked and usually served with a sauce”. For the purpose of examination, the term “pasta” was interpreted in line with this definition, namely that a pasta material requires flour and water.
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, 3-6, 13, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kubalak et al. (US 2006/0025753 A1) in view of O’Flynn et al. (US 2017/0056622 A1), in further view of Clarke et al. (US 2017/0007802 A1), and in further view of Hartig (US 3,664,906 A).
Regarding claim 1, Kubalak discloses a catheter drainage accessory (Figs. 5A-5C, feats. 90, 120, and 125; ¶0046-0049) adapted to be connected to a urinary catheter (Fig. 1, feat. 10; ¶0035), comprising: a connector (Fig. 5C, feat. 92; ¶0048-0049) configured to be operably connected to a drainage member of a urinary catheter (Figs. 1 and 5A-5C, feat. 80; ¶0046-0049); and a drainage conduit for draining urine from the accessory into a waste receptacle (Figs. 5A-5C, feats. 90, 120, and 125; ¶0046: extension tube 120 attaches to a drainage receptacle; ¶0047-0049: accessory connector 92 may be directly connected to drainage bag 125), the drainage conduit having a first end and a second end (Figs. 5A and 5C, feat. 120), the first end being attached to the connector (Figs. 5A and 5C, feat. 80).
Kubalak does not disclose that a drainage funnel is attached to the second end of the drainage conduit, or that at least one of the connector and drainage funnel includes a shell having an outer wall, an inner wall, and a plurality of interconnected interior walls between the outer wall and inner wall, wherein the plurality of interconnected interior walls define a plurality of honeycomb voids, and wherein the inner wall defines a passageway configured for the passage of urine, and wherein the shell is made of a water flushable material.
O’Flynn teaches a catheter assembly (Figs. 20-21, feat. 10d; ¶0062-0065) comprising a catheter portion (62; ¶0062) which connects to an accessory portion (64; ¶0062) via fittings (70, 72) which provide fluid passage from the catheter portion to the accessory portion. The accessory portion includes a fluid drainage funnel (76) on the end opposite to the fitting (72) for connecting to the catheter portion (¶0064). O’Flynn teaches that fluid drainage funnels aid with draining fluid, such as urine, from the catheter into a toilet (¶0059). 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 accessory disclosed by Kubalak so that a drainage funnel is attached to the second end of the drainage conduit in order to aid with draining fluid from the catheter into a toilet as taught by O’Flynn.
Clarke teaches catheter assemblies (Fig. 1, feat. 10; ¶0173) which are made of water disintegrable or enzymatically hydrolysable materials in order to render the catheter assemblies flushable (¶0174-0175). Clarke further teaches that the catheter assembly may further include a flush enhancing or water capture accessory (Figs. 140-145, feats. 564-564c; ¶0319-0322) which comprise a connector (568-568c; ¶0349) for connecting to the opening (Fig. 141, feat. 572; ¶0322) of the drainage member (574) of the catheter (570). Clarke further teaches that the flush enhancing accessory is water disintegrable, and therefore flushable (¶0320). Clarke further teaches that any or all of the catheter, any portions of the catheter, and its accessories, such as flush enhancing or water capture accessories of Clarke, should be flushable (¶0324) in order to enable users to conveniently and quickly dispose of used catheters and their accessories in toilets (¶0003-0009 and 0174). Modifying the accessory of Kubalak in view of O’Flynn so that the drainage funnel, which includes a passageway for the passage of fluid, such as urine, taught by O’Flynn is also flushable as taught by Clarke would enable a user to conveniently and quickly dispose of a used catheter and its accessories as taught by Clarke. 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 catheter drainage accessory disclosed by Kubalak in view of O’Flynn so that at least one of the connector and drainage funnel is made of a water flushable material in order to enable users to conveniently and quickly disposed of a used catheter and its accessories as taught by Clarke.
Hartig teaches structural panels (Figs. 18-20, feat. 160) comprising close-packed tubular members (Figs. 18-19, feat. 164), which may be hexagonal (Fig. 20, feat. 170), sandwiched between a pair of layers (162) to form a honeycomb core panel which is advantageously strong and light-weight (Col. 8, lines 1-54). Because the tubes are close-packed, the walls of the tubes form a plurality of interconnected interior walls between the outer wall and inner wall. Forming such a panel into a conduit or passageway would cause one of the sandwiching layers to become an outer wall and the other sandwiching layer to become an inner wall. 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 catheter drainage accessory disclosed by Kubalak in view of O’Flynn and in further view of Clarke so that at least one of the connector and drainage funnel includes a shell having an outer wall, an inner wall and a plurality interconnected interior walls between the outer wall and inner wall, wherein the plurality of interconnected interior walls define a plurality of honeycomb voids in order for the connector and/or drainage funnel is strong and lightweight as taught by Hartig.
Regarding claims 3-6, Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig discloses the accessory of claim 1. Clarke further teaches that suitable water flushable materials for catheter assemblies include complex carbohydrates like starch, modified starches or derivatives, amylopectin, pectin, xanthan, and other carbohydrates (¶0175). Clarke further teaches that suitable materials include polylactic acid and polyesters, and poly lactic-co-glycolic acid (which is another name for poly (lactic/glycolic acid)), among other materials (¶0175). Therefore, Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig further discloses that the water flushable material is made from a starch, with respect to claim 3, that the water flushable material is made from a complex carbohydrate, with respect to claim 4, that the water flushable material is made of one or more of polylactic acid, polyhydroxyalkanoate, polyanhydrides, and polyesters, with respect to claim 5, and that the water flushable material is made from one or more of copolymers of 1,3-bis(p-carboxyphenoxy)propane and sebacic acid, and poly(lactic/glycolic acid), with respect to claim 6.
Regarding claim 13, Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig discloses the accessory of claim 1, and Kubalak further discloses that the connector (Fig. 5C, feat. 92; ¶0048-0049) comprises a nipple (94; ¶0048) comprising an axially extending urine passageway (Fig. 5C) for insertion into the drainage member of the urinary catheter (Fig. 5C, feat. 80).
Regarding claim 17, Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig discloses the accessory of claim 1. Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig does not explicitly disclose that the drainage accessory degrades in water in over the course of 24-96 hours as claimed. However, as discussed above, Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig discloses an accessory with a substantially identical structure to that of claim 1. Furthermore, while Clarke, which teach water flushable materials, are silent with respect to the time period over which the water flushable materials which the catheter and accessories are made of, Clarke (¶0175) teaches that the catheter and accessories are made of similar materials to those recited in the present specification (Present specification: ¶0015-0017). Because Clarke teaches similar materials to those recited in the present specification, the catheter accessory disclosed by Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig would use similar materials to those recited in the present specification. Therefore, because the catheter accessory disclosed by Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig has substantially the same structure as the claimed accessory and is made of substantially the same materials as the accessory of the present invention, it would be expected to have the same properties, including the amount of time over which the accessory degrades in water. Please see MPEP §2112.01(I) and §2112.01(II). Therefore, Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig inherently discloses that the drainage accessory degrades in water over the course of 24-96 hours. Please see MPEP §2112.
Regarding claims 18 and 19, Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig discloses the accessory of claim 1. As discussed above, Clarke teaches that any or all of the catheter, portions of the catheter, and its accessories, should be flushable in order to enable users to conveniently and quickly dispose of used catheters and their accessories in toilets (¶0003-0009, 0174, and 0324). The connector and drainage funnel disclosed by Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig are part of the accessory, and therefore should include the water flushable shell in order to render them water flushable as suggested by Clarke. Therefore, Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig further discloses that the other of the connector and the drainage funnel includes the shell, with respect to claim 18, and that both the connector and the drainage funnel include the shell, with respect to claim 19.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kubalak et al. (US 2006/0025753 A1) in view of O’Flynn et al. (US 2017/0056622 A1), in further view of Clarke et al. (US 2017/0007802 A1), in further view of Hartig (US 3,664,906 A), and in further view of Svensson et al. (US 2011/0071507 A1).
Regarding claim 7, Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig discloses the accessory of claim 1, but does not disclose that the water flushable material is made from raw pasta.
Svensson teaches flushable medical devices, such as urinary catheters (¶0008-0011) which may be made from low cost, environmentally friendly materials such as sugar or flour, as well as water (¶0018-0019). Svensson teaches exemplary catheters made from dried, extruded mixtures comprising wheat flour and water (¶0069-0085), and therefore teaches catheters made from raw pasta. Svensson teaches that materials such as flour are advantageously cost efficient and environmentally friendly, as well as allowing for cost efficient production (¶0018-019). 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 accessory disclosed by Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig so that the water flushable material is made from raw pasta so that the accessory is environmentally friendly and cost efficient as taught by Svensson.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kubalak et al. (US 2006/0025753 A1) in view of O’Flynn et al. (US 2017/0056622 A1), in further view of Clarke et al. (US 2017/0007802 A1), in further view of Hartig (US 3,664,906 A), and in further view of Fletter et al. (CA 3039487 A1).
Regarding claim 14, Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig disclose the accessory of claim 1, but are silent with respect to the drainage conduit of the accessory comprising a sleeve. Regarding claim 15, Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig are further silent with respect to that sleeve being flexible. Regarding claim 16, Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig are further silent with respect to the sleeve having a compact and expanded configurations.
Fletter teaches a urinary catheter assembly (Figs. 13-17, feat. 100; ¶00044) comprising a connector (16’’) for connecting a catheter tube (112) and a drainage container (114). The connector has an internal flow path (Figs. 16-17; ¶00044, lines 13-14) and an external pleated or corrugated sleeve made of bendable and deformable material (Figs. 16-17; ¶00044, lines 3-11). Fletter teaches that such a sleeve advantageously provides a convenient gripping surface and is flexible and extendable along the central axis of the connector such that the catheter and container may be stored in a side-by-side, compact configuration (Fig. 14; ¶00044, lines 3-12) while also being used in an extended, or expanded, configuration which facilitates insertion and manipulation of the catheter (Fig. 13). 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 accessory disclosed by Kubalak in view of O’Flynn, in further view of Clarke, and in further view of Hartig so that the drainage conduit comprises a sleeve, with respect to claim 14, so that the sleeve is flexible, with respect to claim 15, and so that the sleeve has a compact configuration and an expanded configuration, with respect to claim 16, so that the accessory is provided with a convenient gripping surface, may be stored in a compact configuration with the catheter, and so that the sleeve may be expanded to facilitate insertion and manipulation of the catheter as taught by Fletter.
Conclusion
THIS ACTION IS MADE FINAL. 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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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781