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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/28/26 has been entered.
Response to Amendment
The amendment filed 03/30/26 has been entered. Claims 11 and 28 have been amended. Claims 14-17, 24-27 are in the original/ previously presented form. Claims 1-2, 5-6, 18-20 remain withdrawn. Claims 3-4, 7-10, 12-13, 21-23, and 29 are cancelled. Thus, claims 11, 14-17, and 24-28 remain pending in the application. There were no objections or 112(b) rejections previously set forth in the Final Office Action mailed 01/28/26. Therefore, there are no objections or 112 rejections withstanding.
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.
Claims 11, 16, 26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Thakor et al. (U.S. PGPUB No. 2023/0090684), hereinafter Thakor, in view of Perry (U.S. PGPUB No. 2020/0368421), and DiMatteo (U.S. PGPUB No. 2004/0186461).
Regarding claim 11, Thakor discloses a catheter assembly comprising:
a peritoneal dialysis catheter (see [0003] & [0049]: device may be used for peritoneal dialysis and [0067]: catheter lumen allows for intraperitoneal space to be filled with dialysate and drained in peritoneal dialysis treatment) comprising an elongated catheter body (100, see FIG.1 and [0060]: catheter 100 including trimmable lumen 120 for customizable length) defining a lumen (120, see [0060]: trimmable lumen 120), a distal portion (124) of the elongated catheter body (100) defining a plurality of sidewall openings (see [0060]: tip 125 of 124 has plurality of inlets and outlets) open to the lumen (120, see FIG. 2 for close-up view of openings into lumen 120) and configured to at least one of introduce fluid into a peritoneal cavity of a patient or remove fluid from the peritoneal cavity (see [0060]: venous inlets or arterial outlets--therefore sidewall openings configured for introducing or removing fluid. See, specifically for peritoneal dialysis, [0067]: catheter lumen allows for intraperitoneal space to be filled with dialysate and drained such as when, see [0066]: catheter is connected to PD cycler to perform peritoneal dialysis);
a first cuff (130, see FIG. 1) comprising:
a first cuff body (131); and
a first adhesive (see FIG. 1 and [0061]: an adhesive compatible surface and then [0007], [0026], [0029], & [0069]: an adhesive applied to the adhesive-compatible surface),
wherein the first adhesive (see [0026], [0029], & [0070]) is configured to adhere the first cuff body (131) to the elongated catheter body (see [0026 & 0029]: the adhesive applied to the adhesive compatible surface as shown in FIG. 1 is to adhere the cuff to the lumen 120 of the catheter 100. See the cuff body adhered in FIG. 2) at a first cuff position (first cuff is placed according to [0026] &[0029] and therefore is a first cuff position); and
a plurality of markings disposed on the elongated catheter body indicating catheter cuff positions selectable by a user (see [0063]: cuff mounting projections provided along catheter body by way of attached cuff positioning ratchet),
wherein a first marking of the plurality of markings indicates a distance from a distal end of the elongated body (see [0076]: “the modular catheter is customized to the patient by trimming the lumen to optimize the cuff-to-tip and/or tip-to-hub distances for catheter implantation in the patient's abdomen”. Cuff-to-tip would indicate a distance from the distal end of the catheter body. Marking as in [0063]. see also X1 & X2 in FIG. 3 for visual aid of the distance measured from the distal end of the elongated body—however, FIG. 3 shown in specific use of hemodialysis.),
wherein the first cuff position is the first marking (see [0063], [0076] and FIG. 3 for visual aid relative distal end),
a determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient (see [0056], [0066], & [0076]: amount of catheter tunneled must extend through skin, into subcutaneous tunnel an abdominal wall and therefore this length is determined prior to procedure).
Thakor is silent to the repeated elements of the first cuff in claim 11 also in a second cuff such that the catheter assembly comprises: “a second cuff comprising: a second cuff body; and a second adhesive, wherein the second adhesive is configured to adhere the second cuff body to the elongated catheter body at a second cuff position”.
Thakor is silent to “wherein the distance from the distal end of the elongated catheter body is based on a distance between a peritoneal cavity entrance and a pelvic gutter of the patient,” “wherein a second marking of the plurality of markings indicates a distance from the first marking based on” a determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient, and “wherein the second cuff position is the second marking.”
However, Perry teaches a catheter assembly (see FIG. 2) comprising a peritoneal dialysis catheter (10, see [0053-0054]: assembly for peritoneal dialysis) with a first cuff body (18) and a second cuff body (20) along an elongated catheter body (14, see [0055]: first and second cuffs along catheter and affixed to patient tissue).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the first cuff body configured to be wrapped around the outer surface of the catheter and including a first adhesive disclosed in Thakor such that there is a second cuff body as taught in Perry for the purpose of attaching the device to multiple areas of the patient, such as below the epidermis and the abdominal wall (see [0009] & [0055]), thus achieving the elements of claim 11 also in a second cuff such that the catheter assembly comprises:
“a second cuff comprising:
a second cuff body; and
a second adhesive,
wherein the second adhesive is configured to adhere the second cuff body to the elongated catheter body at a second cuff position.”
Thakor in view of Perry remain silent to wherein the distance from the distal end of the elongated catheter body “is based on a distance between a peritoneal cavity entrance and a pelvic gutter of the patient,” “wherein a second marking of the plurality of markings indicates a distance from the first marking based on” a determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient, and “wherein the second cuff position is the second marking.”
However, DiMatteo teaches a catheter assembly (see [0002]) comprising an elongated catheter body and a cuff mountable on the elongated catheter body (see [0003]), wherein the catheter assembly further comprises a plurality of markings (see markings 214A in FIG. 2A for visual example of markings/mounting projections) disposed on the elongated catheter body (see [0007-0008]) indicating catheter cuff positions selectable by a user (see [0063]). DiMatteo further teaches the markings may be designed to match the cuff locations (see [0063] and [0002-0006] with cuff locations described) and therefore DiMatteo teaches wherein a distance from the distal end of the elongated catheter body (i.e. see ‘Modified FIG. 1Bi’ below)
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is based on a distance between anatomical structures of the patient (see [0063]: a distance between cuff markings can mark a specific location and being based on patient anatomy and [0002-0006]: designing the markings can be according to patient anatomy), wherein a second marking (i.e. see ‘Modified FIG. 1Bi’ above) of the plurality of markings indicates a distance from the first marking (see [0063]: relative correspondence between each marking can be for marking a cuff location) based on an a determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient (see [0063]: markings for indicating cuff location and [0002-0006]: desirable locations according to patient anatomy, especially [0002]: cuff locations may be according to tunneling techniques such as from subcutaneous pocket to the access site such as in an arm which has a length that is patient dependent), and wherein the second cuff position is the second marking (see ‘Modified FIG. 1Bi’ above and [0063]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the distance from the distal end of the elongated catheter body disclosed in Thakor such that the distance is based on a distance between specific anatomical structures relevant to peritoneal dialysis, such as a peritoneal cavity entrance and a pelvic gutter of the patient, as taught by DiMatteo for the purpose of allowing the physician to determine placement of the cuff relative to visible markings after surgery has commenced (see [0002-0006]) and designing the device markings based on patient anatomical structures (see [0063]), thus achieving wherein the distance from the distal end of the elongated catheter body “is based on a distance between a peritoneal cavity entrance and a pelvic gutter of the patient.”
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient disclosed in Thakor to be indicated by a second marking indicating a distance from the first marking as taught by DiMatteo for the purpose of allowing the physician to determine placement of the cuff relative to visible markings after surgery has commenced (see [0002-0006]) and designing the device markings based on patient anatomical structures (see [0063]), thus achieving “wherein a second marking of the plurality of markings indicates a distance from the first marking based on” a determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient, and “wherein the second cuff position is the second marking.”
Regarding claim 16, the modified system of Thakor teaches the catheter assembly of claim 11, and Thakor further discloses wherein the adhesive (see [0007], [0026], [0029], & [0069-0070]: an adhesive applied to the adhesive-compatible surface of cuff body 131 in FIG. 1) is configured to adhere to at least one of silicone, urethane, or polyurethane (see [0070]: adhesive adheres to catheter body and [0067]: catheter body--“lumen” 120 as in FIG. 1—may be formed of silicone, polyurethane, etc. Therefore, the adhesive is configured to adhering to those materials as applied in Thakor.).
Regarding claim 26, the modified system of Thakor teaches the catheter assembly of claim 11, and Thakor further discloses wherein the adhesive (see [0007], [0026], [0029], & [0069-0070]: an adhesive applied to the adhesive-compatible surface of cuff body 131 in FIG. 1) is a pressure sensitive adhesive (see [0072]: adhesive may be pressure sensitive adhesive).
Regarding claim 28, Thakor discloses a catheter assembly comprising:
a peritoneal dialysis catheter (see [0003] & [0049]: device may be used for peritoneal dialysis and [0067]: catheter lumen allows for intraperitoneal space to be filled with dialysate and drained in peritoneal dialysis treatment) comprising an elongated catheter body (100, see FIG.1 and [0060]: catheter 100 including trimmable lumen 120 for customizable length) defining a lumen (120, see [0060]: trimmable lumen 120), a distal portion (124) of the elongated catheter body (100) defining a plurality of sidewall openings (see [0060]: tip 125 of 124 has plurality of inlets and outlets) open to the lumen (120, see FIG. 2 for close-up view of openings into lumen 120) and configured to at least one of introduce fluid into a peritoneal cavity of a patient or remove fluid from the peritoneal cavity (see [0060]: venous inlets or arterial outlets--therefore sidewall openings configured for introducing or removing fluid. See, specifically for peritoneal dialysis, [0067]: catheter lumen allows for intraperitoneal space to be filled with dialysate and drained such as when, see [0066]: catheter is connected to PD cycler to perform peritoneal dialysis);
a first cuff (130, see FIG.1) comprising:
a first cuff body (131) configured to be wrapped at least partially around an outside perimeter (see [0061]: cuff 130 has two halves 133,134 that are “closed around”==wrapped around the outside perimeter of the lumen 120. The cuff after placement onto the catheter body is seen in FIG. 2) of the elongated catheter body (100) at a first cuff position (such as position shown in FIG. 2 and see [0060]: adjustable cuff 130 is placed at a selected position); and
a first adhesive (see FIG. 1 and [0061]: an adhesive compatible surface and then [0007], [0026], [0029], & [0069-0070]: an adhesive applied to the adhesive-compatible surface),
wherein the first adhesive (see [0026], [0029], & [0070]) is configured to adhere the first cuff body (131) to the elongated catheter body (see [0026 & 0029]: the adhesive applied to the adhesive compatible surface as shown in FIG. 1 is to adhere the cuff to the lumen 120 of the catheter 100. See the cuff body adhered in FIG. 2); and
a plurality of markings disposed on the elongated catheter body indicating catheter cuff positions selectable by a user (see [0063]: cuff mounting projections provided along catheter body by way of attached cuff positioning ratchet),
wherein a first marking of the plurality of markings indicates a distance from a distal end of the elongated body (see [0076]: “the modular catheter is customized to the patient by trimming the lumen to optimize the cuff-to-tip and/or tip-to-hub distances for catheter implantation in the patient's abdomen”. Cuff-to-tip would indicate a distance from the distal end of the catheter body. see also X1 & X2 in FIG. 3 for visual aid of the distance measured from the distal end of the elongated body—however, FIG. 3 shown in specific use of hemodialysis.),
wherein the first cuff position is based on the first marking (see [0063], [0076] and FIG. 3 for visual aid relative distal end),
a determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient (see [0056], [0066], & [0076]: amount of catheter tunneled must extend through skin, into subcutaneous tunnel an abdominal wall and therefore this length is determined prior to procedure).
Thakor is silent to the repeated elements of the first cuff in claim 28 also in a second cuff such that the catheter assembly comprises: “a second cuff comprising:
a second cuff body configured to be wrapped around the perimeter of the elongated catheter body at a second cuff position; and a second adhesive, wherein the second adhesive is configured to adhere the second cuff body to the elongated catheter body”.
Thakor is silent to wherein the distance from the distal end of the elongated catheter body “is based on a distance between a peritoneal cavity entrance and a pelvic gutter of the patient,” “wherein a second marking of the plurality of markings indicates a distance from the first marking based on” a determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient, and “wherein the second cuff position is the second marking.”
However, Perry teaches a catheter assembly (see FIG. 2) comprising a peritoneal dialysis catheter (10, see [0053-0054]: assembly for peritoneal dialysis) with a first cuff body (18) and a second cuff body (20) along an elongated catheter body (14, see [0055]: first and second cuffs along catheter and affixed to patient tissue).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the first cuff body configured to be wrapped around the outer surface of the catheter and including a first adhesive disclosed in Thakor such that there is a second cuff body as taught in Perry for the purpose of attaching the device to multiple areas of the patient, such as below the epidermis and the abdominal wall (see [0009] & [0055]), thus achieving the elements of claim 28 also in a second cuff such that the catheter assembly comprises: “a second cuff comprising: a second cuff body configured to be wrapped around the perimeter of the elongated catheter body at a second cuff position; and a second adhesive, wherein the second adhesive is configured to adhere the second cuff body to the elongated catheter body”.
Thakor in view of Perry remains silent to wherein the distance from the distal end of the elongated catheter body “is based on a distance between a peritoneal cavity entrance and a pelvic gutter of the patient,” “wherein a second marking of the plurality of markings indicates a distance from the first marking based on” a determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient, and “wherein the second cuff position is the second marking.”
However, DiMatteo teaches a catheter assembly (see [0002]) comprising an elongated catheter body and a cuff mountable on the elongated catheter body (see [0003]), wherein the catheter assembly further comprises a plurality of markings (see markings 214A in FIG. 2A for visual example of markings/mounting projections) disposed on the elongated catheter body (see [0007-0008]) indicating catheter cuff positions selectable by a user (see [0063]). DiMatteo further teaches the markings may be designed to match the cuff locations (see [0063] and [0002-0006] with cuff locations described) and therefore DiMatteo teaches wherein a distance from the distal end of the elongated catheter body (i.e. see ‘Modified FIG. 1Bi’ below)
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is based on a distance between anatomical structures of the patient (see [0063]: a distance between cuff markings can mark a specific location and being based on patient anatomy and [0002-0006]: designing the markings can be according to patient anatomy), wherein a second marking (i.e. see ‘Modified FIG. 1Bi’ above) of the plurality of markings indicates a distance from the first marking (see [0063]: relative correspondence between each marking can be for marking a cuff location) based on an a determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient (see [0063]: markings for indicating cuff location and [0002-0006]: desirable locations according to patient anatomy, especially [0002]: cuff locations may be according to tunneling techniques such as from subcutaneous pocket to the access site such as in an arm which has a length that is patient dependent), and wherein the second cuff position is the second marking (see ‘Modified FIG. 1Bi’ above and [0063]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the distance from the distal end of the elongated catheter body disclosed in Thakor such that the distance is based on a distance between specific anatomical structures relevant to peritoneal dialysis, such as a peritoneal cavity entrance and a pelvic gutter of the patient, as taught by DiMatteo for the purpose of allowing the physician to determine placement of the cuff relative to visible markings after surgery has commenced (see [0002-0006]) and designing the device markings based on patient anatomical structures (see [0063]), thus achieving wherein the distance from the distal end of the elongated catheter body “is based on a distance between a peritoneal cavity entrance and a pelvic gutter of the patient.”
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient disclosed in Thakor to be indicated by a second marking indicating a distance from the first marking as taught by DiMatteo for the purpose of allowing the physician to determine placement of the cuff relative to visible markings after surgery has commenced (see [0002-0006]) and designing the device markings based on patient anatomical structures (see [0063]), thus achieving “wherein a second marking of the plurality of markings indicates a distance from the first marking based on” a determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient, and “wherein the second cuff position is the second marking.”
Claims 14 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Thakor in view of Perry and DiMatteo as applied to claim 11 above, and further in view of Yamamoto et al. (U.S. Patent No. 4,676,782).
Regarding claim 14, the modified system of Thakor teaches the catheter assembly of claim 11, and Thakor discloses the first cuff body (131, see FIG. 1), but Modified Thakor is silent to “wherein the first cuff body has at least one of a keyed shape or a helical shape.”
However, Yamamoto teaches a cuff for a dialysis catheter (see col. 1 lines 24-26), wherein the cuff body (70, see FIG. 12) has at least one of a keyed shape or a helical shape (see Fig. 12: helical shape and col. 9 lines 33-40: helical sleeve).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first cuff body disclosed in Thakor with the helical shape as taught by Yamamoto for the purpose of providing a desired residual clamping force (see Yamamoto col. 9 lines 33-39) to, for example, ensure the cuff does not separate from the catheter, thus achieving “wherein the first cuff body has at least one of a keyed shape or a helical shape.”
Regarding claim 27, the modified system of Thakor teaches the catheter assembly of claim 11, and Thakor discloses the first cuff body (131, see FIG. 1), but Thakor is silent to “wherein the first cuff body and the second cuff body are different shapes.”
However, Perry teaches a catheter assembly (see FIG. 2) comprising a peritoneal dialysis catheter (10, see [0053-0054]: assembly for peritoneal dialysis) with a first cuff body (18) and a second cuff body (20) along an elongated catheter body (14, see [0055]: first and second cuffs along catheter and affixed to patient tissue).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the first cuff body configured to be wrapped around the outer surface of the catheter and including a first adhesive disclosed in Thakor such that there is a second cuff body as taught in Perry for the purpose of attaching the device to multiple areas of the patient, such as below the epidermis and the abdominal wall (see [0009] & [0055]), thus achieving the first cuff body “and the second cuff body”
Thakor in view of Perry remain silent to wherein the first cuff body and the second cuff body “are different shapes.”
However, Yamamoto teaches a cuff for a dialysis catheter (see col. 1 lines 24-26), wherein the cuff body (70, see FIG. 12) has at least one of a keyed shape or a helical shape (see Fig. 12: helical shape and col. 9 lines 33-40: helical sleeve).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first cuff body disclosed in Thakor with the helical shape as taught by Yamamoto for the purpose of providing a residual clamping force and minimize the material deformation applied to the cuff (see Yamamoto col. 9 lines 33-39) to, for example, ensure the cuff does not separate from the catheter, thus achieving “wherein the first cuff body and the second cuff body are different shapes.”
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Thakor in view of Perry and DiMatteo as applied to claim 11 above, and further in view of Hahne et al. (U.S. PGPUB No. 2015/0359957), hereinafter Hahne.
Regarding claim 15, the modified system of Thakor teaches the catheter assembly of claim 11, and Thakor discloses the first cuff body (131, see FIG. 1), but Modified Thakor is silent to “wherein the first cuff body comprises an antimicrobial coating.”
However, Hahne teaches a peritoneal dialysis catheter (see Fig. 2) with a first cuff body (208) comprising an antimicrobial coating (see [0013]: antimicrobial agent layer and [0015-0016]: antimicrobial may be coat the cuff).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first cuff body disclosed in Thakor to include the antimicrobial coating as taught by Hahne for the purpose of preventing the growth of bacteria at the cuff implantation site (see [0013]), thus achieving “wherein the first cuff body comprises an antimicrobial coating.”
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Thakor in view of Perry and DiMatteo as applied to claim 11 above, and further in view of Ryan et al. (U.S. PGPUB No. 2014/0148788), hereinafter Ryan.
Regarding claim 17, the modified system of Thakor teaches the catheter assembly of claim 11, and Thakor discloses the first cuff (130, see FIG. 1), but Modified Thakor is silent to “wherein the first cuff further comprises a release liner, wherein the release liner is configured to releasably attach to the adhesive.”
However, Ryan teaches a catheter assembly (see FIG. 1) with a user-positionable first cuff (140) along a catheter (100), wherein the first cuff (140, see Fig. 3) further comprises a release liner (150, see [0052]: a protective film 150), wherein the release liner (150) is configured to releasably attach (see [0052]: 150 may be removed, therefore is releasably attached, to adhesive 148) to an adhesive (148).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive on the adhesive compatible surface of the first cuff body disclosed in Thakor to include a release liner as taught by Ryan for the purpose of protecting the adhesive prior to use (see [0052]), thus achieving “wherein the first cuff further comprises a release liner, wherein the release liner is configured to releasably attach to the adhesive”.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Thakor in view of Perry and DiMatteo as applied to claim 11 above, and further in view of Zhu et al. (U.S. PGPUB No. 2020/0339906), hereinafter Zhu.
Regarding claim 24, the modified system of Thakor teaches the catheter assembly of claim 11, and Thakor further discloses wherein the first cuff body (130, see FIG. 1) comprises a polyester fabric (see [0068]: material forming cuff may be polyester/ felt== fabric) and an adhesive (see [0070-0072]: adhesive may be a UV curable adhesive).
Thakor is silent to “wherein the first cuff body and the second cuff body each comprise a polyester fabric and a primer disposed on the polyester fabric, the primer configured to promote adhesion between the adhesive and the polyester fabric.”
However, Perry teaches a catheter assembly (see FIG. 2) comprising a peritoneal dialysis catheter (10, see [0053-0054]: assembly for peritoneal dialysis) with a first cuff body (18) and a second cuff body (20) along an elongated catheter body (14, see [0055]: first and second cuffs along catheter and affixed to patient tissue).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the first cuff body configured to be wrapped around the outer surface of the catheter and including a first adhesive disclosed in Thakor such that there is a second cuff body as taught in Perry for the purpose of attaching the device to multiple areas of the patient, such as below the epidermis and the abdominal wall (see [0009] & [0055]), thus achieving wherein the first cuff body “and the second cuff body” each comprise a polyester fabric and an adhesive.
Thakor in view of Perry is silent to “a primer disposed on the polyester fabric, the primer configured to promote adhesion between the adhesive and the polyester fabric”
However, Zhu teaches a primer for medical catheters that is formed from a hydrophilic coating providing “good” coating adhesion and fast UV curing speed (see Zhu [0043]), such that the primer is configured to promote adhesion (see [0043]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second cuff body comprising polyester fabric and the UV curable adhesive taught by Thakor in view of Perry to include the primer as taught by Zhu for the purpose of promoting adhesion and decreasing adhesive cure time (see [0043]), such as for the UV curable adhesive also disposed on the cuff bodies, thus achieving “a primer disposed on the polyester fabric, the primer configured to promote adhesion between the adhesive and the polyester fabric”.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Thakor in view of Perry and DiMatteo as applied to claim 11 above, and further in view of Wentling et al. (U.S. PGPUB No. 2004/0193098), hereinafter Wentling.
Regarding claim 25, the modified system of Thakor teaches the catheter assembly of claim 11, but Modified Thakor is silent to “wherein at least a distal portion of the elongated catheter body is coiled.”
However, Wentling teaches a catheter assembly (see FIG. 2A) comprising a peritoneal dialysis catheter (10), wherein at least a distal portion (22) of the elongated catheter body is coiled (see FIG. 2A).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal portion of the elongated catheter body disclosed in Thakker with the coiled shape as taught by Wentling for the purpose of increasing the outflow rate during peritoneal dialysis treatment (see [0069]), thus achieving “wherein at least a distal portion of the elongated catheter body is coiled.”
Response to Arguments
Applicant's arguments filed 03/30/26 have been fully considered but they are not persuasive.
On pages 9-13, Applicant appears to argue against the reference DiMatteo alone (especially see page 12 regarding the argument against DiMaetteo’s ‘internal receiving locations’ of the cuffs). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
However, the examiner understands that Applicant’s argument focuses on the amended limitations of wherein the distance from the distal end of the elongated catheter body “is based on a distance between a peritoneal cavity entrance and a pelvic gutter of the patient" or a distance from the first marking "based on a determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient" and Applicant asserts that DiMatteo fails to explicitly teach such recited distances. Although the examiner agrees that DiMatteo may not state these distances verbatim in the disclosure, these marking distances have still been rendered obvious in view of the combination of references. Thakor discloses placing the cuff from a certain distance from the distal end of the catheter based on patient anatomy, desired cuff location, or desired application—i.e.: hemodialysis, peritoneal dialysis, etc. (see at least [0063] and the rejection of claim 11 above). Further, DiMatteo teaches a distance between cuff markings for marking a specific location (see [0063]), the location/ distance can be based on anatomy of a patient (see [0063]), and designing the markings/cuff locations according to patient anatomy, such as how the cuff/catheter will be tunneled (see [0002-0006], especially [0002]). Again, DiMatteo may not explicitly state the marking distance "is based on a distance between a peritoneal cavity entrance and a pelvic gutter of the patient", but DiMatteo does teach selecting marking distance based on patient anatomy and desired cuff locations. Therefore, the examiner asserts that, based on at least the disclosures of Thakor in view of DiMatteo, there is enough suggestion for a person of ordinary skill to have chosen the distance to be between the specific anatomical structures of the peritoneal cavity entrance and a pelvic gutter of the patient (see MPEP § 2123.I which states “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art…”). Similarly, although in the previously referenced paragraphs, Thakor in view of DiMatteo does not explicitly state "the second marking… based on a determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient", DiMatteo does teach choosing markings/cuff locations for tunneling the device. Therefore, Thakor in view of DiMatteo reasonably suggest to a person of ordinary skill in the art to choose the second marking to be based on a determined length based on a tunneling length from the skin to the abdominal wall (again see MPEP § 2123.I ). Therefore, the examiner was not persuaded by the arguments on page 9-13 and has maintained the 35 U.S.C. § 103 claim rejection under Thakor in view of Perry and DiMatteo.
On page 11, Applicant submits that DiMatteo could only be relied upon to teach the amended subject matter if improper hindsight reasoning were applied. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Therefore, the examiner disagrees with this argument regarding hindsight reasoning because a person of ordinary skill in the art would have enough suggestion from the references to arrive at the claimed limitations without turning to Applicant’s disclosure (see MPEP § 2123.I and the preceding paragraphs). Further, in response to applicant's argument that the modified system of Thakor fails to teach the specific markings as “based on” other structures, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Thakor in view of Perry and DiMatteo teach two cuffs that are selectively placed according to a number of markings along a catheter body. Therefore, the modified system of Thakor is capable of having the cuffs placed at any functional location, such as wherein the distance from the distal end of the elongated catheter body “is based on a distance between a peritoneal cavity entrance and a pelvic gutter of the patient,” and the wherein a second marking of the plurality of markings indicates a distance from the first marking “based on a determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient” as currently presented in the amended limitation. Therefore, the examiner was not persuaded by the argument that the 35 U.S.C. § 103 claim rejection is improper hindsight and has maintained the rejection.
Lastly, the examiner asserts that cuff distances and/or markings chosen to indicate a distance “between a peritoneal cavity entrance and a pelvic gutter of the patient” and a distance based on the tunneling length or “a determined length of the elongated catheter to run through skin, subdermal tissue, and an abdominal wall of the patient” would have been obvious location choices to one of ordinary skill in the art of peritoneal dialysis because these locations and lengths are critical to performing peritoneal dialysis (the catheter must enter the peritoneal cavity into the pelvic gutter of the patient to deliver and/or drain the fluid and the catheter must be tunneled through skin/subdermal tissue/ and an abdominal wall of the patient to get to such a location inherently required for performing a peritoneal dialysis operation). Therefore, the examiner was not persuaded by the argument that the 35 U.S.C. § 103 claim rejection is improper hindsight and has maintained the rejection.
No further arguments were presented and therefore the examiner has subsequently maintained the depending claim rejections as well.
Conclusion
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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