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 .
Response to Arguments
Applicant's arguments filed 11/17/25 have been fully considered but they are not persuasive.
On pages 7-8 Applicant argues amendments overcome the rejections of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Claim Objections
Claim 21 is objected to because of the following informalities:
Claim 21 is objected to for claiming the smooth transition “prevent[s] irritation” but it is unclear what might be experiencing irritation (e.g. the stent assembly, or something else). It is unclear how the stent assembly itself might experience irritation, so it appears something else might be experiencing this irritation, but it isn’t clear.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3, 5-11, 14, 16, 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ponsky et al. (WO 2013185128 A1) hereinafter known as Ponsky in view of Bluni et al. (US 20030109930 A1) hereinafter known as Bluni, further in view of Robertson (US 20030195456 A1), and further in view of McWeeney et al. (US 20040059279 A1) hereinafter known as McWeeney.
Regarding claim 22 Ponsky discloses a stent assembly including:
a ureteral stent (Figure 2 item 50) for placement in a bladder, kidney, and a ureteral passageway (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an 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. See MPEP 2111.02 (II). In this case, the patented structure of Ponsky was considered capable of performing the cited intended use. See, for example see Figure 1 and page 6 lines 15-17), the stent including:
a bladder coil (Figure 2 item 52) having a first end, a second end (Figure 2 items 66, 68) and a length extending therebetween,
a tubular kidney member (Figure 2 item 54) positionable in the kidney and ureteral passageway (this is stated as an “intended use” of the kidney member (see the explanation above regarding “intended use” statements). See also Figure 1 where the kidney member is positioned in a kidney/ureteral passageway); and
a tether (Figure 2 item 56) connecting the coil and kidney member (Figure 2), the tether being coupled to the first end of the bladder coil (Figure 2); and
but is silent with regards to the bladder coil being free of a lumen between the first and second ends, and having a conical first end,
and the stent assembly including a single pusher tube to insert the stent, the pusher tube being sized to extend through the ureteral orifice into the ureteral passage way to be able to advance the kidney member to the kidney with the bladder coil being sized to be advanced adjacent the pusher tube.
However, regarding claim 22 Bluni teaches that bladder members can have a first end and a second end (Figures 3a-c item 20, 30) and have a length therebetween which is free from a lumen extending along the length of the bladder member between the first and second ends (Figures 3a-c; [0036] lacking a lumen). Ponsky and Bluni are involved in the same field of endeavor, namely ureteral stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of Ponsky by having the bladder coil being free from a lumen such as is taught by Bluni since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, a previously disclosed type of bladder coil is obviously chosen in lieu of another.
Further, regarding claim 22 Robertson teaches a single pusher tube (Figure 5a item 7) sized to extend through the ureteral orifice into the ureteral passageway to be for inserting the ureteral stent into the kidney, passageway, and bladder (This is stated as an “intended use” of the pusher tube (see the explanation regarding “intended use” statements above). See also [0039], along with the figures 2, 4, and 5a which show the size of the tube 7 which appears to be obviously sized in a way that it would be capable of extending through the ureteral orifice),
wherein the single pusher tube has a first end (Figure 5a item 7 the end which abuts end (23)) and a second end opposite the first end (this is considered to be inherent) so the single pusher tube is configured to advance a tubular kidney member (25) to the kidney (see [0039], Figure 4). Ponsky and Robertson are involved in the same field of endeavor, namely ureteral stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of the Ponsky Bluni Combination by utilizing a pusher tube as is taught by Robertson as a known alternative delivery mechanism than a guidewire alone for delivery that might help minimize irritation for the patient, thus increasing patient satisfaction and comfort. The courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B).
Further, regarding claim 22 McWeeney teaches a bladder member can have a conical first end (Figure 14a item 135). Ponsky and McWeeney are involved in the same field of endeavor, namely ureteral stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the assembly of the Combination so that the first end is conical as is taught by McWeeney in order to minimize any sharp edges at the interface between portions ([0073]), which eases comfort for the patient and prevents injury.
Additionally, the Examiner understands that the Combination, which includes the stent (50) of Ponsky which has bladder coils free of a lumen (Bluni Figures 3a-c) which are much thinner than the stent’s kidney member (Ponsky item 54), would result in the pusher tube’s (Robertson item 7) first end being configured to abut an end of the tubular kidney member (54) of Ponsky, as the pushing of the bladder portion shaped as is taught by Bluni (Figure 1a item 15) would not actually push the stent as a whole, as it is improperly dimensioned to interact with the bladder portion of Bluni (15). This would result in the bladder coil (Bluni 15) being capable of being advanced adjacent the single pusher tube as the pusher (Robertson item 7) extends up towards the kidney member (Ponsky item 54) as the claim requires.
Regarding claim 1 the Ponsky Bluni Robertson McWeeney Combination teaches the assembly of claim 22 substantially as is claimed,
wherein Ponsky further discloses the coil being positionable in the bladder (this is also stated as an “intended use” of the coil (see the explanation above regarding “intended use” statements). See also Figure 1 where the bladder coil is positioned in a bladder) to prevent the coil from migrating into the ureteral passageway (this is also stated as an “intended use” of the coil (see the explanation above regarding “intended use” statements). See also page 6 lines 24-26), and
the tether connecting the bladder coil and tubular kidney member to allow the coil to float in the bladder (this is stated as an “intended use” of the tether (see the explanation above regarding “intended use” statements). See also page 7 lines 1-2; page 10 lines 22-29) and allow a ureteral orifice connecting the ureteral passageway to the bladder to move between a compressed state and an uncompressed state (this is stated as an “intended use” of the tether (see the explanation above regarding “intended use” statements). See also page 10 lines 16-17)
Regarding claim 3 the Ponsky Bluni Robertson McWeeney Combination teaches the stent of claim 1 substantially as is claimed,
wherein Ponsky further discloses the tether is received in an opening of the kidney member such that a first portion of the tether is outside the kidney member and a second portion is inside the kidney member (page 9 lines 21-24), and the tether has first and second ends coupled to the first end of the bladder coil (page 9 lines 26-27).
Regarding claim 5 the Ponsky Bluni Robertson McWeeney Combination teaches the stent of claim 1 substantially as is claimed,
wherein Ponsky further discloses the bladder coil has an eyelet at the second end (Figure 2 shows eyelets 60 and 72, either of which can be considered proximate either end) for receiving a second tether for removing the ureteral stent from a patient (this is stated as an “intended use” of the eyelet (see the explanation above regarding “intended use” statements). The eyelets are understood to be capable of receiving a second tether if desired).,
the eyelet extending in a direction perpendicular to a direction of the length of the stent (Figure 2 shows eyelets extending into the page, which is perpendicular to the stent length).
Regarding claim 6 the Ponsky Bluni Robertson McWeeney Combination teaches the stent of claim 5 substantially as is claimed,
wherein Ponsky further discloses the eyelet is integrally formed at the second end (“integral” is defined by Merriam-Webster as “essential to completeness: constituent; formed as a unit with another part; composed of constituent parts; lacking nothing essential: entire”. The eyelets shown by Ponsky are understood to be constituent parts of the bladder coil).
Regarding claim 7 the Ponsky Bluni Robertson McWeeney Combination teaches the stent of claim 1 substantially as is claimed,
wherein Bluni further teaches the bladder coil which is free of a Lumen has a diameter in the range of about 0.025-0.050 inches (0.635-1.27 mm) (while [0036] indicates the coil has a diameter of 0.15-0.23 mm (see Figure 3c wherein the tether 25 continues on to form the fixation element), [0034] also indicates that the bladder member 15 can be also in the range of 3-10 mm), to allow the bladder coil to be inserted into the bladder alongside the12/ stent pusher (see the rejection to claim 1 above).
Regarding claim 8 the Ponsky Bluni Robertson McWeeney Combination teaches the stent of claim 7 substantially as is claimed,
wherein Young further teaches the bladder coil has a diameter less than or equal to about 0.035 inches (see the rejection to claim 7 above).
Regarding claim 9 the Ponsky Bluni Robertson McWeeney Combination teaches the stent of claim 1 substantially as is claimed,
wherein Bluni further teaches the bladder coil has a diameter less than or equal to about 0.035 inches (0.899 mm) ([0036] item 25 has a diameter of 0.15-0.23 mm; see also Figure 3c wherein the tether 25 continues on to form the fixation element),
and wherein Robertson further teaches the single pusher tube has a diameter of about 7 French (while the figures of Robertson are not understood to be drawn to scale, they are not understood to be completely inaccurate either. The person of ordinary skill, in viewing Figure 1a of Robertson, and reading [0031] understands that the outer diameter of the stent 5 is about 1.6-3.3mm (which represents a range of about 4.8-9.9 French). Figure 1a shows the diameter of the single pusher tube 7 being slightly larger than the stent 5, which means the person of ordinary skill in the art would understand the diameter of the pusher tube 7 to be slightly larger than the stent 5, which has a diameter between about 4.8-9.9 French. The pusher tube 7, being slightly larger than 4.8 French, is accordingly understood to be obviously “about 7 French”. ). The courts have held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. See MPEP 2144.05(II)(A).
Regarding claim 10 Ponsky discloses a stent assembly including:
a ureteral stent (Figure 2 item 50) for placement in a bladder, kidney, and a ureteral passageway (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an 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. See MPEP 2111.02 (II). In this case, the patented structure of Ponsky was considered capable of performing the cited intended use. See, for example see Figure 1 and page 6 lines 15-17), the stent including:
a bladder coil (Figure 2 item 52) having a first end, a second end (Figure 2 items 66, 68) and a length extending therebetween, the coil being positionable in the bladder (this is also stated as an “intended use” of the coil (see the explanation above regarding “intended use” statements). See also Figure 1 where the bladder coil is positioned in a bladder) to prevent the coil from migrating into the ureteral passageway (this is also stated as an “intended use” of the coil (see the explanation above regarding “intended use” statements). See also page 6 lines 24-26), and the bladder coil including an eyelet at the second end in a direction perpendicular to a direction of the length of the stent (Figure 2 item 60),
a tubular kidney member (Figure 2 item 54) positionable in the kidney and ureteral passageway (this is stated as an “intended use” of the kidney member (see the explanation above regarding “intended use” statements). See also Figure 1 where the kidney member is positioned in a kidney/ureteral passageway), the kidney member has a ureter portion (Figure 2 item 78) configured to be positioned in the kidney and passageway to place the ureteral passageway in an open state (this is stated as an “intended use” of the ureter portion (see the explanation regarding “intended use” statements above). See also page 8 lines 21-25) and a resilient fixing portion (Figure 2 item 76 (page 7 lines 18-19)) biased in an unrestrained position (page 7 lines 20-21) to secure the resilient fixing portion in the kidney (this is stated as an “intended use” of the unrestrained position (see the explanation above regarding “intended use” limitations). See also page 7 lines 19-22); and
a first tether (Figure 2 item 56) connecting the coil and ureter portion of the kidney member (Figure 2), to allow the coil to float in the bladder (this is stated as an “intended use” of the tether (see the explanation above regarding “intended use” statements). See also page 7 lines 1-2; page 10 lines 22-29) and allow a ureteral orifice connecting the ureteral passageway to the bladder to move between a compressed state and an uncompressed state (this is stated as an “intended use” of the tether (see the explanation above regarding “intended use” statements). See also page 10 lines 16-17), and the tether being coupled to the first end of the bladder coil (Figure 2);
wherein the kidney member has a second diameter, and the bladder portion has a third diameter which is less than the second diameter (page 12 lines 3-11);
but is silent with regards to the bladder coil being free of a lumen between the first and second ends,
a second tether extending through the eyelet for removing the ureteral stent from a patient,
and the stent assembly including a single pusher tube to insert the stent, the pusher tube being sized to extend through the ureteral orifice into the ureteral passage way to be able to advance the kidney member to the kidney with the bladder coil being sized to be advanced adjacent the pusher tube.
However, regarding claim 10 Bluni teaches that bladder members can have a first end and a second end (Figures 3a-c item 20, 30) and have a length therebetween which is free from a lumen extending along the length of the bladder member between the first and second ends (Figures 3a-c; [0036] lacking a lumen). Ponsky and Bluni are involved in the same field of endeavor, namely ureteral stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of Ponsky by having the bladder coil being free from a lumen such as is taught by Bluni since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, a previously disclosed type of bladder coil is obviously chosen in lieu of another.
Further, regarding claim 10 Robertson teaches a single pusher tube (Figure 5a item 7) sized to extend through the ureteral orifice into the ureteral passageway to be for inserting the ureteral stent into the kidney, passageway, and bladder (This is stated as an “intended use” of the pusher tube (see the explanation regarding “intended use” statements above). See also [0039], along with the figures 2, 4, and 5a which show the size of the tube 7 which appears to be obviously sized in a way that it would be capable of extending through the ureteral orifice), the pusher tube has a first diameter (Figure 1a item 7), and the kidney member (Figure 1a item 12) has a second diameter less than the first diameter (Figure 1a), wherein the single pusher tube has a first end (Figure 5a item 7 the end which abuts end (23)) and a second end opposite the first end (this is considered to be inherent) so the single pusher tube is configured to advance a tubular kidney member (25) to the kidney (see [0039], Figure 4). Ponsky and Robertson are involved in the same field of endeavor, namely ureteral stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of the Ponsky Bluni Combination by utilizing a pusher tube as is taught by Robertson as a known alternative delivery mechanism than a guidewire alone for delivery that might help minimize irritation for the patient, thus increasing patient satisfaction and comfort. The courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B).
Additionally, the Examiner understands that the Combination, which includes the stent (50) of Ponsky which has bladder coils free of a lumen (Bluni Figures 3a-c) which are much thinner than the stent’s kidney member (Ponsky item 54), would result in the pusher tube’s (Robertson item 7) first end being configured to abut an end of the tubular kidney member (54) of Ponsky, as the pushing of the bladder portion shaped as is taught by Bluni (Figure 1a item 15) would not actually push the stent as a whole, as it is improperly dimensioned to interact with the bladder portion of Bluni (15). This would result in the bladder coil (Bluni 15) being capable of being advanced adjacent the single pusher tube as the pusher (Robertson item 7) extends up towards the kidney member (Ponsky item 54) as the claim requires.
Further, regarding claim 10 McWeeney teaches a tether can be utilized for removing a ureteral stent from a patient ([0006] a monofilament thread attached to the bladder end of the stent for removal), but is silent with regards to how it is attached. Since Ponsky teaches tethers can be attached to a ureteral stent via an eyelet (Figure 2 item 72), the person of ordinary skill would have found it obvious to modify the stent of the Combination to include a second tether at the second end of the bladder member as is taught by McWeeney, and attached it via an eyelet (taught by Ponsky) since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the attachment of the tether via any known mechanism would have been obvious to try . It would be obvious to include a tether for removal of the stent in order to provide a method of removal that does not require cytoendoscopy, thus simplifying removal.
Regarding claim 11 the Ponsky Bluni Robertson McWeeney Combination teaches the stent of claim 10 substantially as is claimed,
wherein the Combination further teaches the first and third diameters combined are less than a diameter of a channel of a cystoscope (this is not considered to limit any part of the claimed stent, as the cystoscope is not positively claimed.).
Regarding claim 14 the Ponsky Bluni Robertson McWeeney Combination teaches the stent of claim 10 substantially as is claimed,
wherein Robertson further teaches the first end of the pusher tube has the first diameter (Figure 1a),
but is silent with regards to the second end of the tube having a fourth diameter which is less than the first diameter.
However, regarding claim 14 Ponsky teaches that the kidney portion of the stent tapers continuously from a first to second end, and the bladder portion continues to taper further along its length, to form continuing tapers across each part of the stent (Page 12 lines 3-12). Accordingly the person of ordinary skill in the art, in designing the pusher to follow the size/shape of the indwelling stent, would find it obvious to modify its diameter so that it has a first end with a larger (first) diameter than its second end.
Regarding claim 16 see the rejection to claim 9 above.
Regarding claim 21 the Ponsky Bluni Robertson McWeeney Combination teaches the stent of claim 10 substantially as is claimed,
wherein Ponsky further discloses the first end of the bladder member is coupled to the first tether (Figure 2),
and wherein McWeeney further teaches the first end of the bladder member is a conical first end (Figure 14a item 135),
so the Combination further teaches the first tether is coupled to the conical first end of the bladder coil by creating a smooth transition between the tether and the bladder coil (McWeeney Figure 15a) to prevent irritation (this is stated as a functional limitation of the claim (see the explanation above). See also McWeeney [0073] minimizing sharp edges is considered a mechanism to prevent irritation).
Claim 2, 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ponsky, Bluni, Robertson, and McWeeney as is applied above, further in view of Ponsky et al. (WO 2013185133 A1) hereinafter known as Ponsky ‘133.
Regarding claim 2 the Ponsky Bluni Robertson McWeeney Combination teaches the stent of claim 1 substantially as is claimed,
but is silent with regards to the pusher tube having a radiopaque element.
However, regarding claim 2 Ponsky ‘133 teaches a pusher tube can have a radiopaque element (page 7 line 17-19) along the length (page 7 line 19), and the tube is configured to be inserted into the passageway until the [element] is at the ureteral orifice (this is stated as an “intended use” of the [element] (see the intended use statements above), which the tube is considered capable of performing since it is disclosed as being inserted into the passageway (Abstract)). Ponsky and Ponsky ‘133 are involved in the same field of endeavor, namely ureteral stents. It would have been obvious, at the time the invention was filed, to modify the stent of the Ponsky Bluni Robertson McWeeney Combination to include radiopaque elements as is taught by Ponsky ‘133 in order to enable the physician inserting the stent to visualize where the stent and pusher tube are when being inserted, thus easing insertion and increasing accuracy of placement.
Further, the person of ordinary skill in the art, in reading Ponsky ‘133 would understand the obviousness of having the radiopaque “elements” or tracking markers to take the form of” bands”, since Ponsky ‘133 also teaches the use of radiopaque bands when referring to the “radiopaque element” of the elongate parts of the stent (page 6 lines 13-15). The person of ordinary skill would also understand the radiopaque elements (bands) to obviously be positioned proximate the first end since Ponsky ‘133 discloses the radiopaque elements to be positioned “along the length” of the pushers (page 7 line 19), and this would include locations proximate both ends.
Regarding claim 12 see the rejection to claim 2 above.
Regarding claim 13 the Ponsky Bluni Robertson McWeeney Combination teaches the stent of claim 12 substantially as is claimed,
but is silent with regards to the distance of the band’s location.
However, regarding claim 13, the person of ordinary skill in the art at the time the invention was filed would have found it obvious to have at least one of the bands positioned along the length of Ponsky ‘133 (page 7 line 19) to be positioned at a distance “substantially” equal to the length of the tether from the end of the ureter portion to the bladder coil. First, since the tube of Ponsky ‘133 is designed to abut the ureter end of the kidney member (page 9 lines 4-6), meaning its location would be obvious to mark for the person of ordinary skill in the ureter stent insertion art, but also since the positioning of bands along the entirety of the tube is considered obvious based on Ponsky page 9 line 19, and at least one of the bands would be positioned “substantially equal” to this distance.
Claim 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ponsky, Bluni, Robertson, and McWeeney as is applied above, further in view of Cully et al. (US 20080255678 A1), hereinafter known as Cully.
Regarding claim 4 the Ponsky Bluni Robertson McWeeney Combination teaches the stent of claim 3 substantially as is claimed,
wherein Ponsky further discloses the first and second ends of the tether are coupled to the first end of the bladder coil (Figure 2; page 9 lines 26-29),
but is silent with regards to the two ends being melted to the bladder coil.
However, regarding claim 4 Cully teaches that it is known to connect two parts of a medical device via a thermoplastic melt ([0155]). Ponsky and Cully are involved in the same field of endeavor, namely medical apparatuses, and likewise are involved in the same problems (attachments between dissimilar parts of a medical apparatus). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of the Ponsky Bluni Robertson McWeeney Combination by having the tether ends melted together to connect them to the bladder member, the method of attachment being taught by Cully, as a simple substitution of one known method of connection between prosthetic elements for another known method of attachment, since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, Ponsky discloses any method of attachment of the ends of the tether are sufficient for connecting them (page 9 lines 19-21).
Conclusion
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 12/09/25