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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 15 October 2025 has been entered.
Claim Interpretation
Claim 1 has been amended to describe “… wherein the perforated perinephric coil and the perforated renal coil are disposed [[closer to]] between the closed distal end [[than]] and a junction of the first lumen and the second lumen.”
Claim 11 has been amended with similar language.
The amended claims describe the relative locations of the two coils, the closed distal end and a junction of the two lumens. Annotated Fig. 1 shows that the coils are arranged between the closed distal end and the junction. The amended claims agree with the originally filed drawings.
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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 (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 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)(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.
Claims 1, 2, 6-11 and 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abbas; Tariq (WO 2018191099 A1).
Regarding claim 1, Abbas discloses a pyelo-ureteral stent (p. 1, lines 1-5, a pyelo-ureteral stent for percutaneous intraoperative insertion in a patient; p. 3, lines 10-15, Figs. 1 and 2 show a pyelo-ureteral stent, designated 10);
comprising: a flexible tube including a closed distal end (p. 3, lines 10-15, The primary tube 12a is a generally elongated tube including an open proximal end 14, a closed distal or ureteric end 16);
the flexible tube formed to include a perforated perinephric coil (p. 4, lines 5-10, As shown, the secondary tube 12b can include a looped or coiled perinephric portion 32 with apertures 33 defined along inner and outer portions of the perinephric coil 32); and
a perforated renal coil (p. 3, lines 15-20, The primary tube 12a is a generally elongated tube including an open proximal end 14, a closed distal or ureteric end 16, a renal coil or coiled renal drainage portion 22);
wherein the perforated renal coil is closer to the closed distal end than the perforated perinephric coil (Fig. 1, the renal coil 22 is closer to distal end 16 than perinephric coil 32);
wherein the flexible tube includes a first lumen extending from a first open proximal end and terminating between the perforated perinephric coil and the perforated renal coil (p. 4, lines 5-10, The secondary tube 12b has a closed distal end 34a … As shown, the secondary tube 12b can include a looped or coiled perinephric portion 32 with apertures 33 defined along inner and outer portions of the perinephric coil 32); and
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wherein the flexible tube includes a second lumen extending from a second open proximal end and terminating between the perforated renal coil and the closed distal end (p. 3, lines 15-20, The primary tube 12a is a generally elongated tube including an open proximal end 14, a closed distal or ureteric end 16, a renal coil or coiled renal drainage portion 22 between the proximal 14 and distal ends 16, a perforated internal collection portion 20 proximate the distal end 16, and a primary lumen extending between the proximal end 14 and the distal end 16); and
wherein the perforated perinephric coil and the perforated renal coil are disposed between the closed distal end and a junction of the first lumen and the second lumen (annotated Fig. 2 shows that the perinephric portion 32 and renal coil 22 are disposed between closed distal or ureteric end 16 and a junction between primary tube 12a and secondary tube 12b).
Abbas teaches the invention substantially as claimed by Applicant but assigns different names to the first and second lumens. In other words, Abbas describes all of the structures and features of claim 1, but refers to them by other names. Specifically, Abbas reverses Applicant’s naming system and describes a first lumen (secondary tube 12b and secondary lumen) and a second lumen (primary tube 12a and primary lumen).
Regarding claim 11, Abbas discloses a method of treating a patient with a pyelo-ureteral stent (p. 3, lines 10-15, Figs. 1 and 2 show a pyelo-ureteral stent, designated 10; p. 4, lines 30-35, In operation, the stent 10 can be implanted in an antegrade manner in the ureter U intraoperatively; p. 5, lines 30-35, The stent 10 can be configured for laparoscopic, robotic and/or open deployment);
including a flexible tube including a closed distal end (p. 3, lines 10-15, The primary tube 12a is a generally elongated tube including an open proximal end 14, a closed distal or ureteric end 16);
the flexible tube formed to include a perforated perinephric coil (p. 4, lines 5-10, a looped or coiled perinephric portion 32 with apertures 33); and
a perforated renal coil (p. 3, lines 15-20, a renal coil or coiled renal drainage portion 22);
wherein the perforated renal coil is closer to the closed distal end than the perforated perinephric coil (Fig. 1, the renal coil 22 is closer to distal end 16 than perinephric coil 32);
wherein the flexible tube includes a first lumen extending from a first open proximal end and terminating between the perforated perinephric coil and the perforated renal coil (p. 4, lines 5-10, The secondary tube 12b has a closed distal end 34a … As shown, the secondary tube 12b can include a looped or coiled perinephric portion 32 with apertures 33 defined along inner and outer portions of the perinephric coil 32); and
wherein the flexible tube includes a second lumen extending from a second open proximal end and terminating between the perforated renal coil and the closed distal end (p. 3, lines 15-20, The primary tube 12a is a generally elongated tube including an open proximal end 14, a closed distal or ureteric end 16, a renal coil or coiled renal drainage portion 22 between the proximal 14 and distal ends 16, a perforated internal collection portion 20 proximate the distal end 16, and a primary lumen extending between the proximal end 14 and the distal end 16); and
wherein the perforated perinephric coil and the perforated renal coil are disposed between the closed distal end and a junction of the first lumen and the second lumen (annotated Fig. 2 shows that the perinephric portion 32 and renal coil 22 are disposed between closed distal or ureteric end 16 and a junction between primary tube 12a and secondary tube 12b);
the method comprising: inserting the pyelo-ureteral stent through an abdominal wall of the patient and through the renal pelvic tissue of the patient (p. 4-5, lines 30-5, An anastomosis incision I is made between the patient's renal pelvis and ureter U. The stent 10 is placed into the kidney K and ureter U through the renal pelvis after passing through the abdominal wall BW); and
positioning the perforated renal coil within a kidney of the patient such that the perforated perinephric coil is positioned outside of the kidney (p. 5, lines 1-5, As shown, the stent 10 is properly positioned when the renal coil 22 is positioned in the kidney K, the proximal end 14 extends outside a body wall BW of the patient, and the distal end 16 of the stent 10 ends in the ureter and does not extend into the bladder);
the first open proximal end and the second open proximal end are positioned exterior to the patient (p. 3, lines 25-30, Opening 17 (Fig. 2) at proximal end 14 is selectively sealable with a clamp 35 or other sealing device; p. 4, lines 10-15, The proximal end 34b of the secondary tube 12b can be selectively sealed with a suitable sealing device 36, such as a valve or clamp); and
the closed distal end is positioned within a ureter of the patient (p. 5, lines 1-5, The distal end 16 is positioned in the mid- ureter without extending into the bladder B);
Regarding the rationale that Abbas assigns different names to the first and second lumens, see the discussion of claim 1 above.
Regarding claims 2, 6-10 and 13-20, Abbas discloses a stent and method wherein the first open proximal end and the second open proximal end are each configured to fluidly connect to a bag or container for fluid collection (p. 4, lines 15-20, The proximal end 34b can be secured to a collection bag or container (not shown) to collect drainage from the coiled portion 32; p. 4, lines 25-30, The proximal end 14 can be connected to a collection bag or other suitable container for collecting urine that flows from the kidney through the opening 17 at the proximal end 14 of the primary tube 12a);
wherein the perforated perinephric coil straightens in response to applied tension and retains a coiled shape in the absence of applied tension (p. 4, lines 10-15, Like the renal coil 22, the coiled portion 32 can be straightened when tension is applied but contracts back to a coiled configuration once tension is released);
wherein the perforated renal coil straightens in response to applied tension and retains a coiled shape in the absence of applied tension (p. 3, lines 15-20, The renal drainage portion 22 can be straightened when tension is applied, but contracts back to a coiled configuration once tension is released);
further comprising a coating on an outer surface of the flexible tube, the coating including at least one of a hydrophilic coating and an antibacterial coating; wherein the coating is hydrophilic (p. 5, lines 25-30, The stent 10 can include a hydrophilic and/or antibacterial coating. The entire stent 10 or at least the renal drainage portion can be produced from one or more malleable materials. In an embodiment, the stent 10 is formed from an inert silicone material and includes a hydrophilic coating);
wherein a first portion of the flexible tube remains external to the patient upon a second portion of the flexible tube being implanted in the patient, and wherein the second portion of the flexible tube is constructed of a more malleable material than the first portion of the flexible tube (p. 5, lines 25-30, The portion of the stent configured for internal placement may be produced of a softer or more malleable material than that used for the external V-shaped portion of the stent);
wherein inserting the pyelo-ureteral stent includes applying tension to the flexible tube thereby straightening the perforated perinephric coil and the perforated renal coil as the pyelo-ureteral stent is inserted (p. 4, lines 10-15, Like the renal coil 22, the coiled portion 32 can be straightened when tension is applied but contracts back to a coiled configuration once tension is released);
further comprising draining blood from a perinephric space of the patient via the perforated perinephric coil, the first lumen, and the first open proximal end (p. 2, lines 5-10, Further, when a conventional pyelo-ureteral stent is used, it is generally necessary to insert a separate tube (e.g., Penrose drain) into the patient' s body (below the stent) to serve as a drain for directing blood and/or urine from the perinephric space outside the body; p. 4, lines 5-10, The apertures 33 of the coiled portion 32 allow fluid to pass into the secondary lumen to drain the perinephric space in the event of bleeding or urine leakage);
further comprising draining urine from the kidney of the patient via the perforated renal coil, the second lumen, and the second open proximal end (p. 3, lines 20-25, The drainage portion 22 can include a series of apertures 28 to allow fluid to pass into and/or out of the primary lumen);
further comprising removing the pyelo-ureteral stent by pulling the pyeo-ureteral stent through the abdominal wall of the patient (p. 5, lines 10-15, When it is desired later to remove the stent 10, the stent 10 may be removed from the patient simply by pulling on the proximal end 14 through the body wall BW);
further comprising introducing contrast material into the kidney via the second lumen (p. 5, lines 10-15, For post-operative contrast studies, e.g., one week after surgery, contrast can be injected into the primary tube 12a after inflating balloon valve 30);
wherein the closed distal end is positioned outside of a bladder of the patient (p. 5, lines 1-5, The distal end 16 is positioned in the mid-ureter without extending into the bladder B);
wherein positioning the renal coil within the kidney prevents the pyelo-ureteral stent from migrating after it is positioned (p. 4, lines 25-30, The coiled configuration of the renal coil 22 helps to secure the stent and prevent migrating);
wherein inserting the pyelo-ureteral stent includes laparoscopic or robotic deployment (p. 5, lines 30-35, The stent 10 can be configured for laparoscopic, robotic and/or open deployment).
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.
Claims 3-5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Abbas; Tariq (WO 2018191099 A1) in view of Gemborys; Colleen et al. (US 20160175559 A1).
Regarding claims 3 and 12, Abbas discloses that a portion of the flexible tube is solid throughout (p. 3, lines 10-15, a closed distal or ureteric end 16); and
wherein at least some of the portion of the flexible tube is positioned within the ureter of the patient while the perforated renal coil is positioned within the kidney (p. 5, lines 1-5, The distal end 16 is positioned in the mid-ureter without extending into the bladder B).
To clarify, Abbas discloses that the distal end 16 is closed, therefore the tube necessarily comprises a solid portion at its distal end.
Abbas teaches the invention substantially as claimed by Applicant except for a solid portion extending from a termination point of the second lumen to the closed distal end. Gemborys discloses a medical device and a method of using a medical device (¶ [0006], [0010], [0033] FIGS. 1, 2A, 2B and 2C illustrate a first example medical device 100; ¶ [0049] FIG. 4 illustrates a second example medical device 300; ¶ [0057] FIGS. 6, 7A, 7B, 7C, 7D, 7E, and 7F illustrate a third example medical device 400);
comprising: a flexible tube (¶ [0034] The medical device 100 includes an elongate shaft 110; ¶ [0046], For all lumens, any desired overall flexibility … may also be taken into consideration when selecting suitable lumen shapes, sizes and configurations);
configured to drain fluid from a urinary system (¶ [0042] Similarly, by placing suction force on the first working lumen proximal opening 152, a fluid in the external environment adjacent the first working lumen distal opening 154 can be withdrawn from the external environment and into the first working lumen 150);
the flexible tube formed to include at least first and second anchors (¶ [0058], Also, the medical device includes first 426a, second 426b, and third 426c balloons attached to the elongate shaft 410; ¶ [0059], each of the balloons 426a, 426b, 426c has its own inflation lumen);
wherein the flexible tube includes a first lumen extending from a first open proximal end and terminating between two of the anchors (¶ [0060] A first working lumen 480 extends between a first working lumen proximal opening 452 … to a first working lumen distal opening 454 … a first working lumen intermediate opening 456 … The first working lumen intermediate opening 456 provides access to the first working lumen just as the first working lumen distal opening 454 does); and
wherein the flexible tube includes a second lumen extending from a second open proximal end and terminating between one of the anchors and the tube’s distal end (¶ [0061] A second working lumen 482 extends between a second working lumen proximal opening 492 … to a second working lumen distal opening 494 … the elongate shaft 410 defines a first working lumen intermediate opening 496 … The second working lumen intermediate opening 496 provides access to the second working lumen just as the second working lumen distal opening 494 does);
wherein a portion of the flexible tube is solid throughout, the portion extending from a termination point of the second lumen to the distal end (¶ [0057] Figs. 7A, 7B, 7C, 7D, 7E, and 7F illustrate cross sections where the first working lumen 480 and second working lumen 482 terminate at intermediate locations along shaft 410, as indicated by solid portions).
Gemborys describes how to construct a solid, multi-lumen catheter with lumens that extend to varying extents along the catheter’s length. A skilled artisan would have been able to modify Abbas with Gemborys’s solid portion by constructing the catheter as a multi-lumen tube instead of two discrete tubes. This will streamline the catheter’s cross-section and make it easier to insert through a percutaneous incision. A skilled artisan would have been motivated to modify Abbas’s catheter according to Gemborys since Abbas calls for inserting the catheter through an incision (p. 4-5, lines 30-5, An anastomosis incision I is made between the patient's renal pelvis and ureter U. The stent 10 is placed into the kidney K and ureter U through the renal pelvis after passing through the abdominal wall BW). Therefore, it would have been obvious to modify Abbas with Gemborys’s unified cross-section in order to streamline the catheter and make it easier to insert.
Regarding claim 4, Abbas discloses a stent wherein the portion of the flexible tube has a diameter smaller than an outer diameter of a remaining portion of the flexible tube including the first and/or second lumen (Fig. 2, the distal end near apertures 26 comprises only a single tube (primary tube 12a) while other sections further comprise both secondary tube 12b and air tube 38). Since other portions of the stent comprise more than one tube, their diameter is larger.
Regarding claim 5, Abbas and Gemborys do not explicitly disclose that the portion of the flexible tube has a diameter within the range of 50% to 70% of the outer diameter of the remaining portion of the flexible tube including the first and/or second lumen.
However, Abbas shows that the distal portion cross-section consists of a single tube (primary tube 12a) while other portions include a pair of tubes (secondary tube 12b and primary tube 12a). The solid distal portion consists of only half as many tubes as other portions, and therefore its diameter will be approximately 50% of the two-tube or three-tube portions.
Response to Arguments
Applicant’s arguments filed 15 October 2025 regarding the rejection of claims 1-20 as amended, under 35 USC § 103 over Abbas and Gemborys, have been fully considered and are persuasive. After further consideration, the amended claims are rejected on new grounds under 35 USC § 102 and 103 over Abbas and Gemborys (see above).
Applicant submits that what was intended was for the claim to clarify that the coils are between the junction of the lumens and the closed distal end (remarks p. 7). Examiner acknowledges that the amended claims describe the locations of the coils, junction and closed distal end consistently with the originally filed drawings.
Applicant respectfully disagrees and submits that the claims explicitly state such. The claims recite that the flexible tube includes a first lumen and a second lumen. The flexible tube is a single tube. The flexible tube includes the first lumen and the second lumen (remarks p. 8). Examiner acknowledges that the claims recite “… a flexible tube including a closed distal end … wherein the flexible tube includes a first lumen … wherein the flexible tube includes a second lumen …”
Applicant asserts that as previously stated by Applicant on the record, Abbas only recites separate tubes each with a single lumen (remarks p. 8). Examiner responds that this argument appears to rely on features which are not claimed, such as how the two lumens are joined, how the tube is constructed, the tube’s outer profile or its cross-section. Claims 1 and 11 specify only that the stent comprises a flexible tube, which includes first and second lumens. None of the claims specify how the lumens are joined or their cross-section. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant’s argument appears to rely on how the two lumens couple to each other. Neither Abbas; Tariq Osman Saeed (US 20230264001 A1) nor Applicant’s drawings depict the tube’s cross-section, which must therefore be inferred from the specification and other details of their respective drawings. In Applicant’s drawings, Figs. 1 and 2 show that first lumen 104 and second lumen 106 converge and extend as a unified structure (¶ [0042], the flexible tube 102 includes a first lumen 104 and a second lumen 106). In Abbas, Figs. 1 and 2 show that the primary tube 12a and secondary tube 12b extend in parallel and are joined to each other.
Blanchard; Daniel B. et al. (US 20120041419 A1) discloses a vascular catheter assembly (¶ [0002], [0005], [0041], FIG. 1 … a catheter assembly, generally designated at 10); including first and second lumens (¶ [0041], the catheter assembly ("catheter") 10 includes an elongate catheter tube 12 formed by an outer wall 13 which, together with a septum 15).
In one embodiment, Blanchard arranges the lumens such that the catheter’s outer surface forms a circular or round shape. This embodiment separates the lumens with an internal septum which results in a pair of D-shaped lumens (¶ [0041] As shown, the catheter assembly ("catheter") 10 includes an elongate catheter tube 12 formed by an outer wall 13 which, together with a septum 15). In another embodiment, Blanchard arranges the lumens side-by-side and connects them with a bridge or crease. In this other embodiment, the tube comprises a pair of circular lumens (¶ [0081] FIG. 24 … The tube 12 in the distal portion 30 includes two single lumen tube structures, each defining one of the lumens 14, which are joined via a crease 94 therebetween, best seen in FIG. 25).
Blanchard describes both of these embodiments as a single tube. Blanchard demonstrates that tubes having a round or creased cross-section both constitute a single tube. In both examples, a pair of lumens is joined by either a septum or a crease. Both formats present a unified tube with a pair of lumens.
Likewise, both Applicant’s construction and Abbas’s construction constitute a “flexible tube” according to claims 1 and 11. The claims do not specify the shape of the lumens, nor the appearance of the tube’s outer surface.
Applicant contends that the Office Action also does not directly address the placement of the coils relative to the junction of the lumens (remarks p. 8). Applicant contends that the clarification of the position of the coils as between the junction of the lumens and the closed distal end further highlights this distinguishing feature and distinguishes the claims from Abbas (remarks p. 8). Applicant submits that in short, Abbas does not teach a single, two-lumen tube where the coils are disposed between the lumen junction and the closed distal end (remarks p. 8).
Examiner notes that the current office action addresses the relative placement of the coils, the junction and the closed distal end. Annotated Fig. 2 shows the relative locations of these elements.
Applicant asserts that Gemborys does not remedy the shortcomings of Abbas, instead being cited for different reasons (remarks p. 8-9). Examiner acknowledges that Gemborys is cited as teaching features of dependent claims.
Conclusion
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/Adam Marcetich/
Primary Examiner, Art Unit 3781