DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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 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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over González; Manuel Luque et al. (ES 2828149 A1, published later as US 20230001152 A1) with incorporation of González ‘407; Manuel Luque (EP 2872194 A1, US 20150202407 A1) in view of Middleton; Ian S. et al. (US 20220241552 A1).
Regarding claim 1, González discloses a urinary catheter for a patient (¶ [0001], [0008], [0078] As shown in FIGS. 1 to 9 … a retention device (50); ¶ [0087] With reference to FIGS. 10 to 16 … the free end part of a urinary catheter (10) conveniently inserted into the retention device (50));
wherein the urinary catheter comprises a catheter shaft with a proximal end and a distal end (¶ [0087], flexible tube (74));
wherein the proximal end includes a balloon port on one side of the proximal end (¶ [0087], FIGS. 10 to 16 of the catheter (10) also show a junction section (73) that connects a balloon arranged at the introduction end (not shown) that inflates with a liquid that enters through a secondary channel of the tube towards the introduction end where the balloon is);
an anchor for providing support to the urinary catheter (¶ [0080] wherein from the rear part and upper end of the first portion (51) emerges a tab (53) configured to releasably fasten the retention device (50) to an element external to the user's body; ¶ [0082] In this embodiment, the tab (53) extends from the uppermost end of the first portion (51) downward to almost the lowermost portion of the first portion 51);
a drainage port on another side of the proximal end (¶ [0083], a part of the connection section (70a) of a urinary catheter);
a catheter plug positioned at the end of the drainage port, wherein the catheter plug includes a valve attached to the drainage port, wherein the valve allows the patient to plug or occlude the urinary catheter (¶ [0086], the sliding valve (71) of the urinary catheter (which corresponds to the part where the activation button (72) is located)).
González does not explicitly disclose a distal end including a tip with a plurality of fenestrations. González incorporates González ‘407 by reference (¶ [0008], a urinary catheter such as that described in European patent no. EP2872194A1; ¶ [0088] This specification does not explain the internal functioning of the urinary catheter (10) or the valve (71-72), since it is the same as that described in European patent no. EP2872194A1). González ‘407 discloses a urinary catheter (¶ [0001], [0006], [0029] FIG. 1 shows a urinary catheter 10 with a tube 12);
comprising a catheter shaft with a distal end including a tip with a plurality of fenestrations (¶ [0031] Urine can be discharged at the tip 16 depicted in FIG. 2, when a urinary catheter 10 is inserted in a bladder, through two opposing eye-like openings 32, through the main channel 28 running in the insertion section 14); and
a balloon located below the plurality of fenestrations (¶ [0030] A balloon, not visible in the figures, disposed at the tip 16, can be inflated with a liquid by means of this connecting section 24).
González ‘407 also discloses further details of the plug and valve (¶ [0029], This valve 22 is disposed between the insertion section 14 and the connecting section 18, such that a discharge of urine from the opening 20, or the connecting section 18, respectively, can be prevented when the valve 22 is closed; ¶ [0033], the valve 22, which is designed as a slide valve, is depicted in FIG. 3; ¶ [0037] Another embodiment of a valve 22 for a urinary catheter 10 is shown in FIGS. 5a to 5c … The valve according to FIGS. 5a to 5c has three switching settings).
González and González ‘407 are silent whether the drainage port is longer than the balloon port by 3-7 cm. The drainage port spacing is interpreted as a result-effective variable, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation. The drainage port spacing affects the catheter’s usability through routine experimentation. For example, González ‘407 shows that the opening 20 of the connecting section 18 extends further proximally than the connecting section 24 (Fig. 1).
Too close
Connectors applied to the two ports will clash or overlap too closely
Optimized spacing
A user or caregiver will be able to join connectors to the two ports without clashing
Too far
The catheter’s drain port will extend inconveniently far from the balloon port, or the balloon port will be located too close to the patient
Therefore, it would have been obvious to adjust the drainage port spacing in order to add connectors without clashing, and to locate the balloon port an acceptable distance from the patient. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
González and González ‘407 lack a rounded bottom end and thicker side walls. Middleton discloses a urinary catheter (¶ [0033], [0067] A urinary catheter 10 … in FIGS. 9a and 9b);
comprising a tip having a rounded bottom end defining a bottom end wall thickness (¶ [0068], The catheter body 12 is elongate and has a tip portion 16 near a distal end 13; ¶ [0069] The hollow catheter body 12 has a drainage aperture 14 at the distal end 13 of the catheter body 12);
the tip further including a pair of side walls having a wall thickness greater than the bottom end wall thickness (¶ [0077] In a further embodiment of the catheter, the wall thickness of all or part of the tip portion of the catheter may be thinner than the elongate portion of the catheter, but the total outside diameter of the whole catheter may be constant, if the diameter of the catheter main channel 20 is greater in the tip portion than in the elongate portion of the catheter, as is shown in FIG. 13).
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Middleton makes the tip more flexible and reduces the risk of damaging the patient’s urethra (¶ [0076], Advantageously, by reducing the wall thickness of the catheter body 12, the tip portion 16 becomes softer, which can also lead to a lower risk of damage to the urethra by penetration of the wall). One would be motivated to modify González and González ‘407 with Middleton’s rounded bottom end and thicker side walls to make the catheter safer. Therefore, it would have been obvious to modify González and González ‘407 with Middleton’s rounded bottom end and thicker side walls in order to reduce the risk of injuring the patient’s urethra.
Regarding claims 2 and 3, González discloses a urinary catheter wherein the anchor is designed to attach the urinary catheter to a patient or to a patient's leg (¶ [0026], the fastening element is configured by a tab … connection and release of the retention device by the user to an external element, such as a strap, trousers or other clothing or device, thus avoiding accidental pulling of the catheter inserted therein; ¶ [0080], a tab (53) configured to releasably fasten the retention device (50) to an element external to the user's body).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over González; Manuel Luque et al. (US 20230001152 A1) with incorporation of González ‘407; Manuel Luque (US 20150202407 A1) in view of Panesar; Satwinder S. et al. (US 20240123181 A1).
Regarding claim 4, González discloses a urinary catheter (¶ [0001], [0008], [0078] As shown in FIGS. 1 to 9 … a retention device (50); ¶ [0087] With reference to FIGS. 10 to 16 … the free end part of a urinary catheter (10) conveniently inserted into the retention device (50));
comprising: a catheter shaft with a proximal end and a distal end (¶ [0087], flexible tube (74));
a balloon capable of being filled and drained of solution (¶ [0087], FIGS. 10 to 16 … a balloon arranged at the introduction end (not shown) that inflates with a liquid);
the proximal comprising: a balloon port on one side of the proximal end (¶ [0087], FIGS. 10 to 16 of the catheter (10) also show a junction section (73) that connects a balloon arranged at the introduction end (not shown) that inflates with a liquid that enters through a secondary channel of the tube towards the introduction end where the balloon is);
an anchor for providing support to the urinary catheter (¶ [0080] wherein from the rear part and upper end of the first portion (51) emerges a tab (53) configured to releasably fasten the retention device (50) to an element external to the user's body; ¶ [0082] In this embodiment, the tab (53) extends from the uppermost end of the first portion (51) downward to almost the lowermost portion of the first portion 51);
a drainage port on another side of the proximal end (¶ [0083], a part of the connection section (70a) of a urinary catheter);
a catheter plug positioned at the end of the drainage port, wherein the catheter plug includes a valve attached to the drainage port, wherein the valve allows the patient to plug or occlude the urinary catheter (¶ [0086], the sliding valve (71) of the urinary catheter (which corresponds to the part where the activation button (72) is located)).
González does not explicitly disclose a distal end including a tip with a plurality of fenestrations or small holes. González incorporates González ‘407 by reference (¶ [0008], a urinary catheter such as that described in European patent no. EP2872194A1; ¶ [0088] This specification does not explain the internal functioning of the urinary catheter (10) or the valve (71-72), since it is the same as that described in European patent no. EP2872194A1). González ‘407 discloses a urinary catheter (¶ [0001], [0006], [0029] FIG. 1 shows a urinary catheter 10 with a tube 12);
comprising a catheter shaft with a distal end including a tip with a plurality of small holes designed to remove urine from a patient's bladder (¶ [0031], two opposing eye-like openings 32); and
a balloon (¶ [0030] A balloon, not visible in the figures, disposed at the tip 16, can be inflated with a liquid by means of this connecting section 24).
González and González ‘407 are silent whether the drainage port is longer than the balloon port by 2-10 cm. The drainage port spacing is interpreted as a result-effective variable. Regarding the rationale and motivation to modify and optimize the drainage port spacing, see the discussion of claim 1 above.
González and González ‘407 lack a helical tip having holes defined as an interstitial helical space. Panesar discloses a urinary catheter (¶ [0003], [0007], [0028], [0029] Turning now to FIGS. 2-4, there is shown one embodiment of a urinary catheter 100; ¶ [0048] FIGS. 16-18 illustrate another embodiment of a urinary catheter 500);
comprising a tip having an helical thread form with a plurality of small holes defined as an interstitial helical space between adjacent helical thread segments (¶ [0049] The proximal insertion end portion 504 includes a terminal proximal end 508, which may be a closed end or an open end. The proximal insertion end portion 504 also includes drainage hole region 510 (FIG. 16) located distally of the proximal terminal end 508); and
configured to remove urine from a patient's bladder (¶ [0049], The drainage hole region 510 includes a plurality of drainage holes 512 extending through the proximal insertion end portion 504 and in communication with the drainage lumen 506 (not shown));
at least one side wall extending over the helical thread form and configured to support the helical thread form during insertion (Figs. 16 and 17 show portions of the catheter shaft 502 where the drainage holes 512 are absent, and which represent solid portions of the catheter shaft 502).
Panesar makes the catheter’s tip more flexible (¶ [0051] Referring to FIG. 18, the drainage holes 512 are sized, shaped, and patterned to impart a selected or desired flexibility to the proximal insertion end portion 504. For example, the flexibility of the drainage hole region 510 may be between 30% and 70%, preferably 40% and 60% more flexible than the flexibility of a portion 520 of the catheter shaft 502 distal of the drainage hole region). One would be motivated to modify González and González ‘407 with Panesar’s helical tip to reduce the risk of injuring the patient with a rigid tip. Therefore, it would have been obvious to modify González and González ‘407 with Panesar’s helical tip in order to make the catheter safer and less likely to injure a patient.
Regarding claim 5, González does not disclose details of the catheter’s tip. González ‘407 discloses a tip made from a flexible and pliable material (¶ [0009] Advantageously, a urinary catheter of this type, or the tube, respectively, can be manufactured from rubber and/or latex and/or polyvinyl chloride (PVC) and/or silicone; ¶ [0032], the tip 16 thus has a spherical cone 34. This spherical cone 34 serves to facilitate an easy insertion of the urinary catheter 10, wherein this should be designed such that it is as comfortable for the patient as possible).
Regarding claim 6, González and González ‘407 are silent whether the drainage port is longer than the balloon port by 4-5 cm. The drainage port spacing is interpreted as a result-effective variable. Regarding the rationale and motivation to modify and optimize the drainage port spacing, see the discussion of claim 1 above.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over González; Manuel Luque et al. (US 20230001152 A1) with incorporation of González ‘407; Manuel Luque (US 20150202407 A1) in view of Sliwa; John W. et al. (US 20120172843 A1).
Regarding claim 7, González discloses a urinary catheter (¶ [0001], [0008], [0078] As shown in FIGS. 1 to 9 … a retention device (50); ¶ [0087] With reference to FIGS. 10 to 16 … the free end part of a urinary catheter (10) conveniently inserted into the retention device (50));
comprising: a catheter shaft with a proximal end and a distal end (¶ [0087], flexible tube (74));
a balloon capable of being filled and drained of solution (¶ [0087], FIGS. 10 to 16 … a balloon arranged at the introduction end (not shown) that inflates with a liquid);
the proximal comprising: a balloon port on one side of the proximal end (¶ [0087], FIGS. 10 to 16 of the catheter (10) also show a junction section (73) that connects a balloon arranged at the introduction end (not shown) that inflates with a liquid that enters through a secondary channel of the tube towards the introduction end where the balloon is);
an anchor for providing support to the urinary catheter (¶ [0080] wherein from the rear part and upper end of the first portion (51) emerges a tab (53) configured to releasably fasten the retention device (50) to an element external to the user's body; ¶ [0082] In this embodiment, the tab (53) extends from the uppermost end of the first portion (51) downward to almost the lowermost portion of the first portion 51);
a drainage port on another side of the proximal end (¶ [0083], a part of the connection section (70a) of a urinary catheter); and
a catheter plug positioned at the end of the drainage port (¶ [0086], the sliding valve (71) of the urinary catheter (which corresponds to the part where the activation button (72) is located)).
González does not explicitly disclose a tip with a plurality of small holes. González incorporates González ‘407 by reference (¶ [0008], [0088]). González ‘407 discloses a distal end comprising a tip with a plurality of small holes designed to remove urine from a patient's bladder (¶ [0031], two opposing eye-like openings 32); and
a balloon located below the plurality of fenestrations capable of being filled and drained of solution (¶ [0030] A balloon, not visible in the figures, disposed at the tip 16, can be inflated with a liquid by means of this connecting section 24).
González and González ‘407 are silent whether the drainage port is longer than the balloon port by 2-10 cm. The drainage port spacing is interpreted as a result-effective variable. Regarding the rationale and motivation to modify and optimize the drainage port spacing, see the discussion of claim 1 above.
Regarding claim 7, González and González ‘407 lack a tip configured as an accordion spring. Sliwa discloses a bendable catheter (¶ [0003], [0005], [0031], [0032], FIG. 1, a catheter 10 includes an elongate body 100 having a convoluted tip portion 110 with a length 180 at its distal end; ¶ [0061], the polymeric "mandrel" may permanently remain a part of the catheter thereby avoiding the traditional electroforming step of dissolving the mandrel);
comprising a tip configured as an accordion spring (¶ [0037] The convoluted tip portion 110 includes an electroformed pleated region 120; ¶ [0039] The electroformed pleated region 120 is formed by a plurality of individual pleats 170);
with a plurality of small holes positioned within a pleated depression of the accordion spring (¶ [0055] Irrigant fluid emission orifices 220 shown in FIG. 4 can be laser drilled. Laser drilling is particularly advantageous, as the laser drilled holes can be drilled anywhere in the electroformed pleated region 120 and can thus jet fluid in almost any direction since pleat faces may be directed in numerous directions).
Sliwa describes how to construct a flexible catheter tip with plural openings. One would be motivated to modify González and González ‘407 with Sliwa’s accordion spring tip since González ‘407 suggests to vary the tip’s configuration (¶ [0016] Advantageously, the urinary catheter has a closed hollow tip with at least two opposing openings, in accordance with the Nelaton catheter design … It is, however, also conceivable, that the urinary catheter is a Foley catheter. A Foley catheter exhibits a Nelaton tip, and has an additional balloon on its tip for securing the urinary catheter in the bladder) and also calls for configuring the tip as a soft or deformable element (¶ [0032], This spherical cone 34 serves to facilitate an easy insertion of the urinary catheter 10, wherein this should be designed such that it is as comfortable for the patient as possible). Therefore, it would have been obvious to modify González and González ‘407 with Sliwa’s accordion spring tip in order to provide a suitable perforated tip for a catheter.
Regarding claim 8, González does not disclose details of the valve. González ‘407 discloses a drainage port including a valve, and wherein the valve allows the patient to release and occlude the urinary catheter (¶ [0029], This valve 22 is disposed between the insertion section 14 and the connecting section 18, such that a discharge of urine from the opening 20, or the connecting section 18, respectively, can be prevented when the valve 22 is closed; ¶ [0033], the valve 22, which is designed as a slide valve, is depicted in FIG. 3; ¶ [0037] Another embodiment of a valve 22 for a urinary catheter 10 is shown in FIGS. 5a to 5c … The valve according to FIGS. 5a to 5c has three switching settings).
Regarding claim 9, González does not disclose details of the catheter’s tip. González ‘407 discloses a tip made from a flexible and pliable material (¶ [0009] Advantageously, a urinary catheter of this type, or the tube, respectively, can be manufactured from rubber and/or latex and/or polyvinyl chloride (PVC) and/or silicone; ¶ [0032], the tip 16 thus has a spherical cone 34. This spherical cone 34 serves to facilitate an easy insertion of the urinary catheter 10, wherein this should be designed such that it is as comfortable for the patient as possible).
Regarding claim 10, González and González ‘407 are silent whether the drainage port is longer than the balloon port by 4-5 cm. The drainage port spacing is interpreted as a result-effective variable. Regarding the rationale and motivation to modify and optimize the drainage port spacing, see the discussion of claim 1 above.
Response to Arguments
The second instance of claim 4 and claims 5-9 have been renumbered to avoid duplicating claim 4.
The amended drawing sheets of Figs. 4A-4C and ¶ [0054], [0055] of the specification filed 22 December 2025 have been accepted.
The objections to claims 1, 4 and 6 minor informalities are withdrawn in view of the amendments filed 22 December 2025.
Applicant’s arguments filed 22 December 2025 regarding the rejection of claims 1-10 as amended, under 35 USC § 103 over González and González ‘407, have been fully considered and are persuasive. After further consideration, the amended claims are rejected on new grounds under 35 USC § 103 over González and González ‘407, Middleton, Panesar and Sliwa (see above).
Applicant submits that none of the cited references describe catheters having a tip configuration as shown in Figs. 4A-4C. Thus, applicant submits that claims 1, 4, and 7 are patentable over the art of record (remarks p. 7). Examiner responds that Middleton, Panesar and Sliwa are cited in the new grounds of rejection as teaching features of amended claims 1, 4 and 7. Middleton, Panesar and Sliwa disclose catheters having variously configured tips as discussed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ruzicka; Petr et al. US 4950232 A
Bartolome; Francis FR 2788222 A1
Frassica, James J. US 20020045855 A1
Byrne, Phillip Owen US 20030135200 A1
Schaeffer; Darin G. US 20070135830 A1
Min; Sung Woo et al. US 20100145265 A1
Hawkins; Irvin et al. US 20100256487 A1
Lyttle; Sean US 20170165001 A1
Middleton; Ian S. et al. US 20220241551 A1
Göbel; Fred US 20220296355 A1
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 extension fee 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 date of this final action.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781