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 .
In light of the amendments to the claims filed 03/23/2026, in which claims 1, 12, and 16 were amended, claims 1-3, 6-14, and 16-19 are pending in the instant application and are examined on the merits herein.
Finality
The finality of the Office Action filed 02/04/2026 has been withdrawn.
Priority
The instant application claims priority to EP/22183939.2 filed on 07/08/2022.
Claims 1-3, 6-14, and 16-19 receive priority to the prior-filed application, filed on 07/08/2022.
Response to Arguments
Objections to the Claims
The objections to the claims are withdrawn in view of the amendments to the claims filed 03/23/2026.
Rejections of the Claims under 35 U.S.C. 103
Applicant’s arguments, see pg. 6-12, filed 03/23/2026, with respect to the rejection(s) of claim(s) 1-3, 6-11, and 13-14 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection of Fuqua in view of in re Harza has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Fuqua in view of Nardeo as explained below.
Regarding claims 12 and 16-19, applicant's arguments filed 03/23/2026 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding claim 12, the applicant asserts on pg. 6-12 that the prior art to Fuqua in view of in re Harza fails to disclose the amendments to the claim.
In response to the applicant’s argument, the examiner notes that Fuqua in view of in re Harza was not used in the previous Office Action filed 02/04/2026 to read on the newly added limitations to claim 12.
Regarding claims 16-19, the applicant asserts on pg. 12 that the prior art to Ewing fails to disclose the amendments to the claims.
In response to the applicant’s argument, the examiner notes that Ewing was not used in the previous Office Action filed 02/04/2026 to read on the newly added limitations to claim 16; however, Ewing can be considered to read on the newly added limitations as explained below.
The amendments to the claims have necessitated new grounds of rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent no. 4,738,666 A to Fuqua in view of US/2011/0190736 A1 to Young and WO/2004/019760 A2 to Nardeo.
Regarding claim 1, Fuqua discloses a urinary catheter assembly (col. 4 ln. 18-30; col. 6 ln. 15-25; Fig. 7) comprising a urinary catheter including a catheter shaft (Fig. 7, catheter 10 comprising catheter shaft 14), and an introducer device including a splitable tubular sheath (Fig. 7, splitable tubular sheath 60; col. 5 ln. 18-40), wherein the introducer device is arranged to accommodate at least a part of the catheter shaft (Fig. 7 showing splitable tubular sheath 60 accommodating at least part of catheter shaft 14; col. 5 ln. 29-40); wherein the introducer device comprises a first end, and a second end remote from the first end, and at least one tear line extending between the first and second ends (col. 5 ln. 29-40, 62 perforations run the length of sheath 60; Fig. 7 showing first and second longitudinal ends of sheath 60 opposite from each other).
Fuqua differs from the instantly claimed invention in that Fuqua fails to disclose wherein at least a part of an outer surface of the splitable tubular sheath includes a hydrophilic coating or hydrophilic surface.
Young teaches a catheter introducer including a splitable tubular sheath (Fig. 3, introducer 10 comprising splitable tubular sheath 16), and wherein at least a part of an outer surface of the splitable tubular sheath includes a hydrophilic coating or hydrophilic surface that advantageously reduces friction between the sheath and the urethra (para. 0053).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the outer surface of the splitable tubular sheath of Fuqua to comprise the hydrophilic coating of Young, because Young teaches that providing a hydrophilic coating may advantageously reduce friction between the sheath and the urethra (para. 0053).
Further, Fuqua differs from the instantly claimed invention in that Fuqua fails to disclose at least two tear lines extending between the first and second ends, the tear lines being separated from each other in a circumferential direction.
Nardeo teaches a catheter comprising a sheath with two tear lines extending between first and second ends, the tear lines being separated from each other in a circumferential direction to allow for the sheath to be split into two approximate halves that may be pulled curvilinearly during removal of the sheath to clear the catheter’s proximal obstacles (Fig. 2, catheter sheath 14 comprising tear seams 58; para. 0029, two tear seams 58 are present and located on opposite sides of the sheath 14; para. 0047).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the sheath of the cited prior art to comprise a second tear line as taught by Nardeo, because Nardeo teaches that this allows for the sheath to be split into two approximate halves that may be pulled curvilinearly during removal of the sheath to clear the catheter’s proximal obstacles, which best accomplishes the goal of removing the sheath while leaving the catheter in place (para. 0047).
Regarding claim 2, the cited prior art suggests the invention of claim 1. Fuqua further discloses: wherein the introducer device is arranged to accommodate at least an insertable part of the catheter shaft (col. 4 ln. 58-68 and col. 5 ln. 1-28; col. 6 ln. 15-25; Fig. 7 showing tubular sheath 60 accommodating a large portion of catheter shaft 14).
Regarding claim 3, the cited prior art suggests the invention of claim 1. Fuqua further discloses: wherein the splitable tubular sheath has an inner diameter greater than an outer diameter of the catheter shaft (Fig. 1 and 5, tubular sheath 60 having an inner diameter greater than outer diameter of catheter shaft 14 in a folded configuration).
Regarding claim 6, the cited prior art suggests the invention of claim 1. Fuqua further discloses: wherein the splitable tubular sheath comprises a flexible material (col. 4 ln. 58-68 and col. 5 ln. 1-9).
Regarding claim 10, the cited prior art suggests the invention of claim 1; however, the prior art differ from the instantly claimed invention in that they fail to disclose wherein the splitable tubular sheath has a Shore A hardness which is greater than the Shore A hardness of the catheter shaft of the urinary catheter.
It would have been obvious to try to one of ordinary skill in the art before the effective filing date of the instant application to utilize a splitable tubular sheath with a Shore A hardness greater than the Shore A hardness of the catheter shaft of the urinary catheter since there are only a finite number of predictable solutions (i.e. Shore 00, A, and D // harder, softer, and equal). Fuqua discloses that the sheath of their invention should preferably be flexible and made with a high doxemeter rating (high tensile strength) to provide high resilience and resistance to stretching in order to prevent unfolding of the folded catheter when the sheath is in place and that at least the retention element of the catheter should be made with a lower doxemeter rating than the catheter to allow for stretching and elasticity (col. 4 ln. 58-68 and col. 5 ln. 1-9); therefore, Fuqua clearly contemplates the use of lower hardness materials for flexibility that may be more commonly measured on the Shore A scale and contemplates the use of lower tensile strength materials for at least parts of the catheter shaft as compared to the sheath. Thus, utilizing a splitable tubular sheath with a Shore A hardness greater than a Shore A hardness of the catheter shaft of the urinary catheter would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that the product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under §103." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 11, the cited prior art suggests the invention of claim 10; however, the prior art differ from the instantly claimed invention in that they fail to disclose wherein the tubular sheath has a Shore A hardness in the range 70-90, and the catheter shaft has a Shore A hardness in the range 40-60.
As explained above, it would have been obvious to try to one of ordinary skill in the art before the effective filing date of the instant application to utilize a splitable tubular sheath with a Shore A hardness greater than the Shore A hardness of the catheter shaft of the urinary catheter since there are only a finite number of predictable solutions (i.e. Shore 00, A, and D // harder, softer, and equal). Further, there are only a finite number of hardness values within the Shore A scale (i.e. 0-100 ha). Fuqua discloses that the sheath of their invention should preferably be flexible and made with a high doxemeter rating (high tensile strength) to provide high resilience and resistance to stretching in order to prevent unfolding of the folded catheter when the sheath is in place and that at least the retention element of the catheter should be made with a lower doxemeter rating than the catheter to allow for stretching and elasticity (col. 4 ln. 58-68 and col. 5 ln. 1-9); therefore, Fuqua clearly contemplates the use of lower hardness materials for flexibility that may be more commonly measured on the Shore A scale and contemplates the use of lower tensile strength materials for at least parts of the catheter shaft as compared to the sheath. Thus, utilizing a tubular sheath with a Shore A hardness exceeding 65 and a catheter shaft with a Shore A hardness of 60 or lower would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that the product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under §103." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 12, Fuqua discloses a urinary catheter assembly (col. 4 ln. 18-30; col. 6 ln. 15-25; Fig. 7) comprising a urinary catheter including a catheter shaft (Fig. 7, catheter 10 comprising catheter shaft 14), and an introducer device including a splitable tubular sheath (Fig. 7, splitable tubular sheath 60; col. 5 ln. 18-40), wherein the introducer device is arranged to accommodate at least a part of the catheter shaft (Fig. 7 showing splitable tubular sheath 60 accommodating at least part of catheter shaft 14; col. 5 ln. 29-40), wherein the urinary catheter comprises an expandable retention element, and wherein the introducer device is arranged to maintain the expandable retention element in a compressed state when accommodating the catheter shaft (Fig. 8, inflation balloon 38 on catheter 10; col. 5 ln. 63-68 and col. 6 ln. 1-6), wherein the splitable tubular sheath comprises a first end, and a second end remote from the first end, and at least one tear line extending between the first and second ends (col. 5 ln. 29-40, 62 perforations run the length of sheath 60; Fig. 7 showing first and second longitudinal ends of sheath 60 opposite from each other).
Fuqua differs from the instantly claimed invention in that Fuqua fails to disclose wherein at least a part of an outer surface of the splitable tubular sheath includes a hydrophilic coating or hydrophilic surface.
Young teaches a catheter introducer including a splitable tubular sheath (Fig. 3, introducer 10 comprising splitable tubular sheath 16), and wherein at least a part of an outer surface of the splitable tubular sheath includes a hydrophilic coating or hydrophilic surface that advantageously reduces friction between the sheath and the urethra (para. 0053).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the outer surface of the splitable tubular sheath of Fuqua to comprise the hydrophilic coating of Young, because Young teaches that providing a hydrophilic coating may advantageously reduce friction between the sheath and the urethra (para. 0053).
Further, Fuqua differs from the instantly claimed invention in that Fuqua fails to disclose at least two tear lines extending between the first and second ends, the tear lines being separated from each other in a circumferential direction.
Nardeo teaches a catheter comprising a sheath with two tear lines extending between first and second ends, the tear lines being separated from each other in a circumferential direction to allow for the sheath to be split into two approximate halves that may be pulled curvilinearly during removal of the sheath to clear the catheter’s proximal obstacles (Fig. 2, catheter sheath 14 comprising tear seams 58; para. 0029, two tear seams 58 are present and located on opposite sides of the sheath 14; para. 0047).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the sheath of the cited prior art to comprise a second tear line as taught by Nardeo, because Nardeo teaches that this allows for the sheath to be split into two approximate halves that may be pulled curvilinearly during removal of the sheath to clear the catheter’s proximal obstacles, which best accomplishes the goal of removing the sheath while leaving the catheter in place (para. 0047).
Regarding claim 13, the cited prior art suggests the invention of claim 1. Fuqua further discloses: wherein the catheter shaft, when accommodated in the introducer device, has an insertable tip portion protruding out from the splitable tubular sheath of the introducer device (Fig. 7 showing insertion end tip 18 protruding out from tubular sheath 60; col. 5 ln. 55-62).
Regarding claim 14, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the current combination of the prior art fails to explicitly disclose wherein the splitable tubular sheath includes a hydrophilic coating on an inner surface thereof.
Young teaches a catheter introducer including a splitable tubular sheath (Fig. 3, introducer 10 comprising splitable tubular sheath 16), and wherein the splitable tubular sheath includes a hydrophilic coating on an inner surface thereof that advantageously reduces friction between the sheath and the catheter or any other instrument (para. 0053).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the outer surface of the splitable tubular sheath of Fuqua to comprise the hydrophilic coating of Young, because Young teaches that providing a hydrophilic coating may advantageously reduce friction between the sheath and the catheter or any other instrument (para. 0053).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fuqua, Young, and Nardeo as applied above, and further in view of US/2013/0018309 A1 to Ewing.
Regarding claims 7-9, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that they fail to disclose
(Claim 7) wherein the introducer device further comprises at least one gripping element arranged at, or in the vicinity of, a non-insertable end of the introducer device;
(Claim 8) at least two gripping elements, the gripping elements being separated or distributed from each other in a circumferential direction; and
(Claim 9) wherein the at least one gripping element is arranged to protrude outwardly, in a radial direction, from the splitable tubular sheath.
Ewing teaches
(Claim 7) an introducer device for a catheter that comprises two gripping elements arranged at, or in the vicinity of, a non-insertable end of the introducer device that allows the tear-away sheath to be held with one hand to maintain the sheath in proper orientation while the catheter is being inserted through the sheath (Fig. 1A showing handle 14 with two gripping elements at, or in the vicinity of, a non-insertable end of tubular sheath 8; para. 0032; para. 0034);
(Claim 8) at least two gripping elements, the gripping elements being separated or distributed from each other in a circumferential direction (Fig. 1A showing handle 14 with two gripping elements separated from each other in a circumferential direction; para. 0032; para. 0034); and
(Claim 9) wherein the at least one gripping element is arranged to protrude outwardly, in a radial direction, from the splitable tubular sheath (Fig. 1A showing handle 14 with two gripping elements arranged to protrude outwardly in a radial direction from tubular sheath 8; para. 0032; para. 0034).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the non-insertable end of the introducer of the cited prior art to further comprise the gripping elements of Ewing, because Ewing teaches that the handle allows the tear-away sheath to be held with one hand to maintain the sheath in proper orientation while the catheter is being inserted through the sheath (para. 0034).
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over US/2013/0018309 A1 to Ewing.
Regarding claim 16, Ewing discloses a catheter assembly (Fig. 11, Fig. 12A-C) comprising a catheter including a catheter shaft (Fig. 11, Fig. 12A-C, catheter 22 comprising proximal shaft 46), a cutting/splitting aid (Fig. 11, cutting device having a blade 40 and cover 42), and an introducer device (Fig. 1A-2B, embodiments of tear-away sheath 8 comprising handle; Fig. 12A, tear-away sheath 8 comprising tubular element 10 and stop 16; Fig. 13A, tear-away sheath 8 comprising axial fault line 12; para. 0042), wherein the cutting/splitting aid is configured for severing the introducer device (para. 0041-0042), wherein the introducer device comprises a first end, and a second end remote from the first end (Fig. 12A, tear-away sheath 8 comprising a first end and a second remote end comprising stop 16), and at least two tear lines extending between the first and second ends, the at least two tear lines extending between the first and second ends, the at least two tear lines being separated from each other in a circumferential direction (Fig. 1A-2B, embodiments of tear-away sheath 8 comprising tear lines 12 extending between first and second ends; para. 0033, tubular element 10 may comprise tear lines 12 on diametrically opposite sides; para. 0037, stop 16 may have at least one tear line 12 aligned with tear line(s) 12 of tubular element 10; para. 0041, tubular element 10 may have at least one tear line 12).
Ewing differs from the instantly claimed invention in that Ewing fails to explicitly disclose a urinary catheter assembly comprising urinary catheter.
These limitations are considered functional language as the term “urinary catheter” is used to denote “the use, function, and/or positioning of the device” as being a catheter used to drain urine. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Ewing discloses all the structure as claimed, and the disclosure of Ewing may be used with medical devices including drainage catheters (para. 0028). As such, at least one medical device in the disclosure of Ewing is capable of performing the functions as claimed (i.e. it is capable of functioning as a urinary drainage catheter).
Regarding claim 17, the cited prior art suggests the invention of claim 16. Ewing further discloses: wherein the cutting/splitting aid is connected to a guide arrangement of the catheter assembly (para. 0041-0042; Fig. 11, Fig. 12A-C, cutting device may be integrated in shaft 46, strain relief 50, or hub 44).
Regarding claim 18, the cited prior art suggests the invention of claim 16. Ewing further discloses: wherein the cutting/splitting aid is one of a pin or blade (Fig. 11, cutting device having a blade 40 and cover 42).
Regarding claim 19, the cited prior art suggests the invention of claim 16. Ewing further discloses: wherein the cutting/splitting aid is configured to penetrate into the introducer device as the introducer device is pulled past the cutting/splitting aid (para. 0041-0042).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
14 April 2026
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