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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in The United Kingdom, number 2203906.9 on 21 March 2022. It is noted, however, that applicant has not filed a certified copy of the 21 March 2022 application as required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 17 calls for “…wherein the catheter is formed of a polyolefin material, preferably polyethylene and/or polypropylene …” This language is ambiguous because the term “preferably” does not clearly specify whether polyethylene and polypropylene are the only acceptable options, or whether other polyolefins are included in the claim scope.
Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. See MPEP 2173.05(d).
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 10, 13-15, 19 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gale; Robert M. et al. (US 4505703 A).
Regarding claim 1, Gale discloses an intermittent catheter assembly (col. 1, lines 5-10; col. 2, lines 20-25; col. 3, lines 15-20, FIG. 1, apparatus 10; col. 4, lines 25-30, FIG. 4 illustrates another embodiment of the invention. FIG. 4 shows a patient-care apparatus 40);
comprising: a catheter having a proximal end for insertion into the body and a distal end (col. 3, lines 35-40, Drainage catheter 20 has an adapter 21 attached to one end thereof for receiving an incoming catheter, not shown, from a catheterized patient); and
a fluid collection bag arranged to receive fluid from the distal end of the catheter (col. 3, lines 15-20, FIG. 1, apparatus 10 comprises a receptacle 11 that is a container for receiving and storing a biological fluid);
wherein the fluid collection bag comprises a hand strap (col. 3, lines 45-50, A hanging strap 25 is suitably attached to receptacle 11 for suspending receptacle 11 in a fluid receiving position at the bedside of a catheterized patient).
Gale does not explicitly describe hanging strap 25 as a hand strap, and instead describes that the strap 25 suspends the bag at a patient’s bedside (col. 3, lines 45-50). However, Gale’s strap 25 is fully capable of operating as a hand strap since it extends along the bag’s top surface and presents a large diameter that a user can grasp. Applicant’s specification defines the term “hand strap” solely in terms of the strap’s functionality (¶ [0011] ‘Hand strap’ as used herein means a strap sized to be easily gripped by hand). Gale’s strap 25 meets this definition since it is large enough for a person to grasp it.
Regarding claim 26, Gale discloses a method of manufacturing an intermittent catheter assembly (cols. 1-2, lines 65-5; to make available to the medico-surgical arts a patient-care urinary drainage collection system … and which device embraces inventive simplicity, is inexpensive to make and is disposable; col. 2, lines 20-25; col. 3, lines 15-20, FIG. 1, apparatus 10);
comprising the steps of providing a catheter having a proximal end for insertion into the body and a distal end (col. 3, lines 35-40, Drainage catheter 20 has an adapter 21 attached to one end thereof for receiving an incoming catheter, not shown, from a catheterized patient); and
a fluid collection bag, arranging the fluid collection bag to receive fluid from the distal end of the catheter (col. 3, lines 15-20, FIG. 1, apparatus 10 comprises a receptacle 11 that is a container for receiving and storing a biological fluid);
wherein the fluid collection bag comprises a hand strap (col. 3, lines 45-50, A hanging strap 25 is suitably attached to receptacle 11 for suspending receptacle 11 in a fluid receiving position at the bedside of a catheterized patient).
Regarding the method of manufacturing an intermittent catheter assembly, Gale does not explicitly disclose steps related to constructing the bag. However, the claim describes the manufacturing method only in terms of “providing … arranging” and does not elaborate on these steps. Gale discloses an equivalently broad method of providing a catheter and arranging a bag.
Regarding claims 2, 3, 10, 13-15 and 19, Gale discloses an intermittent catheter assembly according herein the fluid collection bag receives fluid via an inlet arranged at an edge of the fluid collection bag, and the hand strap is arranged at the same edge as the inlet (col. 3, lines 35-40, Receptacle 11 has an inlet port 19 for receiving incoming catheter 20 that establishes fluid communication between the interior and the exterior of receptacle 11);
wherein the inlet and hand strap are each arranged at an upper edge of the fluid collection bag (Figs. 1 and 4 each shows an inlet and hand strap arranged at an upper edge of the fluid collection bag);
wherein the size of hand strap is fixed (Figs. 1 and 4, hanging strap 25 lacks any features for adjusting its length);
wherein the width of the hand strap is constant along its entire length (Figs. 1 and 4, hanging strap 25 consists of a flat strip fastened into a loop);
wherein the hand strap comprises two ends, each end being attached to the fluid collection bag at substantially the same position on the fluid collection bag (Figs. 1 and 4, hanging strap 25 consists of a flat strip fastened into a loop that attaches to the bag at substantially one location);
wherein the fluid collection bag comprises an outlet arranged on a front panel and toward the base of the fluid collection bag (col. 3, lines 40-45, An outlet port 22 is positioned at the bottom of receptacle 11 distant from inlet 19. A receptacle drainage tube 23 is connected to outlet port 22, and it is equipped with a pinch clamp 24 for controlling the volume of fluid drained from receptacle 11);
wherein at least 10% of the surface of the fluid collection bag is opaque (col. 3, lines 25-35, Preferably, front wall 14 is made from a transparent plastic such as plasticized polyvinyl chloride and rear wall 16 is made of an opaque plastic such as polyvinyl chloride containing titanium dioxide).
Claims 1 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O'Flynn; Padraig M. et al. (US 20200360174 A1).
Regarding claim 1, O'Flynn discloses an intermittent catheter assembly (¶ [0002], urine collection containers used with … an intermittent urinary catheter; ¶ [0008], [0046] FIG. 3 … receptacle 10; ¶ [0051] FIG. 4 … receptacle 50);
comprising: a catheter having a proximal end for insertion into the body and a distal end (¶ [0047], a port 20 extending through the peripheral seal 12 to allow urine to flow into the bag 10 from a urinary catheter); and
a fluid collection bag arranged to receive fluid from the distal end of the catheter (¶ [0046] FIG. 3 shows a portion of a urinary collection bag or receptacle 10; ¶ [0051], The bag 50 of FIG. 4 is configured similarly to the bag 10 of FIG. 3, except for the handle seal 52);
wherein the fluid collection bag comprises a hand strap (¶ [0048] A handle seal 22 joins the first and second walls, to define a handle opening 24; ¶ [0051], The bag 50 of FIG. 4 is configured similarly to the bag 10 of FIG. 3, except for the handle seal 52).
Regarding claim 26, O'Flynn discloses a method of manufacturing an intermittent catheter assembly (¶ [0002], urine collection containers used with … an intermittent urinary catheter; ¶ [0004], In the embodiment of FIG. 1, a urinary collection bag B is formed of flexible first and second opposing walls … folded in half in a V-shape format, which are joined about their perimeters at a perimeter seal P … A handle seal H is defined adjacent to an intersection of one of the edges R and one of the ends F; ¶ [0008], [0046] FIG. 3 … receptacle 10; ¶ [0051] FIG. 4 … receptacle 50);
comprising the steps of providing a catheter having a proximal end for insertion into the body and a distal end (¶ [0047], a port 20 extending through the peripheral seal 12 to allow urine to flow into the bag 10 from a urinary catheter); and
a fluid collection bag, arranging the fluid collection bag to receive fluid from the distal end of the catheter (¶ [0046] FIG. 3 shows a portion of a urinary collection bag or receptacle 10; ¶ [0051], The bag 50 of FIG. 4 is configured similarly to the bag 10 of FIG. 3, except for the handle seal 52);
wherein the fluid collection bag comprises a hand strap (¶ [0048] A handle seal 22 joins the first and second walls, to define a handle opening 24; ¶ [0051], The bag 50 of FIG. 4 is configured similarly to the bag 10 of FIG. 3, except for the handle seal 52).
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gale; Robert M. et al. (US 4505703 A).
Regarding claim 9, Gale discloses that the hand strap has a length equal to at least 50% of the length of the fluid collection bag (Figs. 1 and 4, hanging strap 25 is approximately half as long as bag 10 or 40).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Gale; Robert M. et al. (US 4505703 A) in view of House; Jamie Glen(US 20100312203 A1).
Regarding claims 4-6, Gale discloses that the fluid collection bag comprises an upper edge joined to a left lateral edge and a right lateral edge, and the fluid collection bag receives fluid via an inlet arranged at the upper edge of bag (col. 3, lines 35-40, Receptacle 11 has an inlet port 19 for receiving incoming catheter 20 that establishes fluid communication between the interior and the exterior of receptacle 11).
Gale does not arrange the hand strap at an opposite end of the fluid collection bag to an outlet or on a corner, and is silent whether the strap is attached to the bag by a weld. House discloses an intermittent catheter assembly (¶ [0003], [0005], [0006], [0016], [0030] FIG. 1 shows a catheter 150 and a fluid collection bag 100);
comprising: a catheter having a proximal end for insertion into the body and a distal end; and a fluid collection bag arranged to receive fluid from the distal end of the catheter (¶ [0030] FIG. 1 shows a catheter 150 and a fluid collection bag 100);
wherein the fluid collection bag comprises a handle (¶ [0030], Finally, attaching member 120 provides a means to attach fluid collection bag 100 to, for instance, a wheelchair);
wherein the handle is arranged at an opposite end of the fluid collection bag to an outlet (¶ [0030], Fluid collection bag 100 includes first tearable portion 104, which when torn exposes small-diameter tube 108 to an external environment);
wherein the fluid collection bag comprises an upper edge joined to a left lateral edge and a right lateral edge, and the fluid collection bag receives fluid via an inlet arranged at the upper edge of bag (¶ [0030], Inlet port 112 provides fluid communication between reservoir 102 and catheter 150); and
the handle is arranged on a corner where the upper edge and left lateral edge meet, or a corner where the upper edge and right lateral edge meet (Fig. 1, attaching member 120 is arranged along a top corner; ¶ [0039] FIG. 5 shows an attaching member 520 coupled to a fluid collection bag 500);
wherein the handle is joined to the bag by a weld (¶ [0031], Fluid collection bag 200 is stamped and welded to create a reservoir 202 … Such welding may be accomplished, for instance, by radio frequency (RF) welding; ¶ [0039] FIG. 5 … During manufacture, hook 520 is coupled to inlet port 512, and the outer edges of the two plastic sheets can be welded to form fluid collection bag 500; ¶ [0048], Optionally, step S882 includes a hook coupled to the inlet portion. This is the hook welded into the fluid collection bag, as described with respect to FIG. 5).
House configures the assembly to attach to a wheelchair (¶ [0030], Finally, attaching member 120 provides a means to attach fluid collection bag 100 to, for instance, a wheelchair; ¶ [0041], In other embodiments, a hook is utilized to hang from a front strap or bar of a wheelchair). House also constructs the bag and its components with a widely known technique. One would be motivated to modify Gale with House’s welded, corner-mounted handle so that the bag can attach to another fixture. For example, Gale calls for attaching the bag to a bed frame (col. 3, lines 45-50, A hanging strap 25 … for suspending receptacle 11 in a fluid receiving position at the bedside of a catheterized patient). A skilled artisan would have been able to modify Gale with House’s teachings by relocating Gale’s hand strap towards a corner, and affixing it to the bag via welding. Therefore, it would have been obvious to modify Gale with House’s welded, corner-mounted handle in order to adapt the catheter assembly for a wheelchair.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gale; Robert M. et al. (US 4505703 A) in view of Sellers; Brent H. et al. (US 20230138293 A1).
Regarding claims 17 and 18, Gale is silent whether the catheter is formed of a polyolefin or thermoplastic elastomeric material. Sellers discloses a urinary catheter and method for making a urinary catheter product (¶ [0002], [0009], [0010], [0025] FIG. 1 illustrates a urinary catheter 50 having catheter polymer tubing 60; ¶ [0028], a package 70 as shown in FIG. 2);
wherein the catheter is formed of a polyolefin material, preferably polyethylene and/or polypropylene; wherein the intermittent catheter is formed of a thermoplastic elastomeric material (¶ [0036] Thermoplastic Urethane (TPU, Pellethane®), Polyvinyl Chloride (PVC), and Styrene-Ethylene-Butylene-Styrene/Polypropylene (SEBS/PP) Based Thermoplastic Elastomer (TPE) CH14 catheter tubing materials of different shore hardness (A) were packed in coiled configurations with three different lengths of the portion of the polymer tubing as measured from the proximal location to the distal location when in a straight configuration (L0=78.5, 122, and 166.5); ¶ [0041] Polyvinyl Chloride (PVC), Thermoplastic Elastomer (TPE), and polyolefin based elastomers (TPO) CH14 tubing materials of different shore hardness (A) were packed in coiled configurations in a medium package (L1=122); ¶ [0045] PVC with shore hardness 91 A, TPE with shore hardness 88 A, and TPU with shore hardness 90 A Ch 14 catheter tubing was packed in three different pack sizes to compare the shape recovery between materials and pack designs).
Sellers constructs urinary catheters from commercially available polymers, and selects materials with good shape recovery (¶ [0046], In all three pack sizes, the TPU material shows better shape recovery than the TPE and PVC material). One would be motivated to modify Gale with Sellers’s SEBS/PP material since Gale is otherwise silent regarding the materials in the catheter. Therefore, it would have been obvious to modify Gale with Sellers’s various polymeric materials in order to construct Gale’s catheter from easily obtained materials.
Claims 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Gale; Robert M. et al. (US 4505703 A) in view of Steer; Peter L. (US 4909478 A).
Regarding claims 20-23, Gale discloses a valve (col. 3, lines 40-45, A receptacle drainage tube 23 is connected to outlet port 22, and it is equipped with a pinch clamp 24 for controlling the volume of fluid drained from receptacle 11).
Gale’s valve lacks a valve base, outlet element and handle. Steer discloses a tap for a drainage bag; including a fluid collection bag comprising an outlet valve configured to control release of fluid out of the fluid collection bag in use (col. 1, lines 25-30; col. 2, lines 15-25; col. 2, lines 40-45, The tap is a two part tap and its body is shown in FIGS. 2 and 3 and its valve member in FIGS. 4 and 5. The valve body shown in FIGS. 2 and 3 is of plastics material and may be injection molded);
the outlet valve comprising: a valve base attached to a panel of the fluid collection bag (col. 2, lines 45-50, flat flange 36);
the valve base comprising a base opening for receiving a liquid output from the fluid collection bag (col. 2, lines 50-55, A liquid exit port 37 extends through the flange 36); and
an outlet element configured to be laterally rotatable relative to the valve base from a closed configuration to an open configuration (col. 2, lines 55-65, The valve member shown in FIGS. 4 and 5 may also be injection molded from plastics material and includes a substantially tubular hollow housing 50 closed at one end by a wall 52 and having extending radially outwardly therefrom an arm 54; col. 3, lines 5-10, When the ports 37, 62 are in registry the "open" legend is exposed);
wherein the outlet element comprises a handle operable to rotate the outlet element between the closed configuration and the open configuration; wherein the handle is planar (col. 2, lines 60-65, A flat plate 56 is integral with the arm 54 and extends upwardly therefrom. The plate 56 serves as a deformable handle portion of the valve member);
wherein the plane of handle is aligned with the plane of the panel of the fluid collection bag to which the valve base is attached, when in the closed configuration (col. 3, lines 10-15, whereas when the handle 56 and arm 34 are positioned as shown in FIG. 5 the "closed" legend is exposed).
Steer reliably controls fluid movement out of a urine collection bag with an easily manipulated valve. One would be motivated to modify Gale with Steer’s outlet valve so that a user can more reliably drain the bag. Gale otherwise relies on a tube segment and pinch valve that do not address the problem of fluid residing in the tube segment (col. 3, lines 40-45, A receptacle drainage tube 23 is connected to outlet port 22, and it is equipped with a pinch clamp 24). Therefore, it would have been obvious to modify Gale with Steer’s outlet valve in order to minimize residual fluid and to more easily manipulate the valve.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Glass; Daniel S. US 3865165 A
Steer; Peter L. et al. US 4462510 A
Kent; Garnet J. et al. US 4516267 A
Feldman; Maria C. US 5279589 A
Carson; John P. US 5346708 A
Edwards; John Victor US 5902294 A
Sturgis, Sheldon et al. US 20020102032 A1
Kavanagh; Seamus T. et al. US 6578709 B1
Tanghoej; Allan et al. US 6635036 B1
Hansen; Henrik Christian et al. US 6849070 B1
Burtoft; Bonnie Beth US 20060189962 A1
Kujat; Marcus et al. US 20080013866 A1
Tanghoj; Allan et al. US 20110213343 A1
Letellier; Godfrey T. US 20130245585 A1
O'Brien; Daniel E. et al. US 20150105756 A1
Koesters; Jens et al. US 20200031527 A1
Holroyd; Simon et al. US 20210251795 A1
Henry; Jerome A. et al. US 20220409420 A1
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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 is assigned is 571-273-8300.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights