DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed October 11, 2025.
Status of Claims
1. Claims 1-8 and 19-23 are pending and currently under consideration for patentability.
Response to Amendment
2. It is acknowledged that claims 9-18 are cancelled and claims 19-23 are newly presented as of the October 11, 2025 claim amendment.
Claim 1 has been amended to overcome the previously applied claim objections, and 35 U.S.C. 112(b)/35 U.S.C. 101 rejections; accordingly, these objections and rejections have been withdrawn herein.
Response to Argument
3. Applicant’s arguments with respect to claim(s) 1, 9 and 13 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., applicant argues that “Wan’s markers are distributed along the guidewires length for fluoroscopic measurements, not specifically positioned at the proximal end for visual inspection”) are not recited in the rejected claim(s). 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). Namely, the claims merely require “visual indicia located between the ends in proximity to the proximal end,” which does not preclude from a guidewire having indicia distributed along its entire length, since the markers are not explicitly required to only reside in proximity to the proximal or distal end.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., applicant argues that Wan’s “fluoroscopic visualization is fundamentally different from direct visual inspection of indicia”) are not recited in the rejected claim(s). 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). Namely, the claims do not require “direct visual inspection of indicia” (viewed by the naked eye) as argued – rather the claims merely require “visual indicia aiding in the proper placement by providing the medical professional a visual queue…” which does not preclude from queues visualized through standard visualization techniques.
Applicant’s amendments have necessitated a new grounds of rejection over Wan in view of Ayala; accordingly, Ayala is merely being utilized as a secondary reference for its teachings and suggestions Arguments presented against Ayala as a primary reference of rejection is therefore deemed moot.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
4. Claims 1-8 and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Wan et al. (US PGPUB 2017/0173312) in view of Ayala et al. (US PGPUB 2015/0011834).
5. With regard to claims 1-3, 5, 7-8, 19-20 and 22, Wan discloses a system for guidewire placement (Figs. 8A, 8B) of a ureteral stent (800; abstract) comprising: a guidewire (872) configured for placement into a ureter (802) of a patient via a cytoscope ([0005]), the guidewire (872) having: a length defined between a proximal end and a distal end (Fig. 8B); fluoroscopic indicia (radiopaque markers, 876 closest to distal tip, 874) located between the ends in proximity to the distal end, and spaced a placement distance from the distal end (see placement distances a, b, c, d; Fig. 8B; [0069]); and fluoroscopic indica (876 closest to bladder, 818; Figs. 8A, 8B) located between the ends in proximity to, and along, the proximal end ([0069]); and a ureteral stent (800) configured to: thread over the guidewire (872) for delivery into a proper placement in the patient ([0070]); and remain in the proper placement when the guidewire and scope are withdrawn ([0071]); wherein: the ureteral stent (800) has a distal curled end configured to be located in the kidney upon the proper placement and a proximal curled end to be located in the bladder upon the proper placement ([0007]; [0068]); the fluoroscopic indicia (876 both proximally and distally) are fully capable of aiding in the proper placement by providing a medical professional a fluoroscopic queue that the distal end of the guidewire is sufficiently located within the kidney (816; [0069]; Fig. 8A), and aiding in the proper placement by providing the medical professional a visual queue (visualized using standard visualization techniques, including fluoroscopy or other imaging techniques; [0069]) indicative of a properly selected length of the ureteral stent (800; steps 881, 883, 885; [0071]), that upon delivery of the ureteral stent (800) and then subsequent guidewire (872) and cytoscope withdrawal, the distal curled end of the ureteral stent (800) will remain in the kidney and the proximal curled end of the ureteral stent will remain in the bladder ([0007]; [0068]; [0070-0071]).
While Wan’s proximal fluoroscopic indica (876 closest to 818; Fig. 8B; [0069]) are fully capable of being visualized and are visualized in step 881 (Fig. 8C; [0071]), Wan is silent in regard to a visual indica located between the ends in proximity to, and along, the proximal end; wherein the visual indicia include multiple bands of multiple colors along the proximal end, wherein the bands are greater than 2 centimeters.
However, Ayala discloses a system and method for introducing multiple medical devices (abstract; Figs. 44, 45A, 45B), comprising a guidewire (wire guide, 11) for receiving a dilator catheter (88; [0005-0006]; [0009]; [0011]; [0025]) for a patient, wherein the guidewire (11) includes visual indicia (series of indicia, 134) along a proximal end (59) aiding in the proper placement by providing a medical professional a visual queue that the distal end of the guidewire is sufficiently located within the kidney; wherein the visual indicia includes multiple bands of multiple colors (yellow, orange, red; [0112]; [0026]; Fig. 45A), and wherein the bands are greater than 2 centimeters (5 cm, [0026]; 6 cm, [0112], 10 cm intervals; [0142]; [0016]; [0112]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the plurality of proximal indicia disclosed by Wan to include multiple bands of colors, similar to that disclosed by Ayala, in order to provide a more discerning, and visually distinct, indication between the different bands of indicia, as suggested by Ayala in paragraph [0112]; allowing a physician to more readily determine which size stent is necessary, as suggested by Wan in paragraph [0069], by color-code.
6. With regard to claims 4 and 6, while guidewires are well-known in the art to be metallic, Wan fails to explicitly disclose that the guidewire is a metallic wire with a j-shaped curve at the distal end of the guidewire.
However, Ayala discloses that the guidewire (11) is a metallic wire (e.g. nitinol; [0119]; [0097]) with a j-shaped curve is at the distal end (60, 80; Figs. 5, 7; [0107]; [0119]; [0137]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the plurality of guidewire disclosed by Wan in view of Ayala to be a metallic wire with a j-shaped curve at its distal end, similar to that disclosed by Ayala, in order to provide a well-known metallic guidewire with a proximal end that is typically oriented down and away from the operator (when rotated as such) and thus, out of the working area surrounding the access port of the endoscope while still allowing the physician to access the proximal end for the advancing the next device, as suggested by Ayala in paragraph [0119].
7. With regard to claim 21, Wan discloses that the proper placement (Fig. 8C) and properly selected length of the ureteral stent (800) is determined when: the fluoroscopic indicia (872) is located at the ureteropelvic junction (Fig. 8A); and the visual indica (as modified by Ayala) is located at the ureterovesical junction (Fig. 8A; [0011]; [0068-0071]).
8. With regard to claim 23, Wan discloses a method (Fig. 8C; [0071]) comprising: initiating insertion of a guidewire (872) into a ureter (802) of a patient (step 877), the guidewire (872) having: a length defined between a proximal end and a distal end; fluoroscopic indicia (radiopaque markers, 876 closest to distal tip, 874) located between the ends in proximity to the distal end, and spaced a placement distance from the distal end (see placement distances a, b, c, d; Fig. 8B; [0069]); and fluoroscopic indica (876 closest to bladder, 818; Figs. 8A, 8B) located between the ends in proximity to the proximal end ([0069]); receiving a fluoroscopic queue from the fluoroscopic indicia (876) indicative that the distal end of the guidewire (872) is sufficiently located within a kidney (816; Fig. 8A [0069]; steps 879, 881); ending insertion of the guidewire (872; [0071]); receiving a visual queue (visualized using standard visualization techniques, including fluoroscopy or other imaging techniques; [0069]) from the fluoroscopic indicia (876) indicative of a properly selected length of the ureteral stent (800; steps 881, 883, 885; [0071]); threading a ureteral stent (800) of the properly selected length over the guidewire (872; step 887); inserting, based upon the fluoroscopic indicia (876), a distal curled end of the ureteral stent (800) into the kidney (816) of the patient to provide a proper placement of the ureteral stent in the patient (Fig. 8C; step 889); and removing the guidewire from the ureter ([0070-0071]); wherein upon using the properly selected length of the ureteral stent (800), upon removal of the guidewire from the ureter, a proximal curled end of the ureteral stent 1s located in and remains in a bladder (802) and the distal curled end of the ureteral stent remains in the kidney ([0007]; [0068]).
While Wan’s proximal fluoroscopic indica (876 closest to 818; Fig. 8B; [0069]) are fully capable of being visualized and are visualized in step 881 (Fig. 8C; [0071]), Wan fails to explicitly disclose a visual indica located between the ends in proximity to the proximal end.
However, Ayala discloses a system and method for introducing multiple medical devices (abstract; Figs. 44, 45A, 45B), comprising a guidewire (wire guide, 11) for receiving a dilator catheter (88; [0005-0006]; [0009]; [0011]; [0025]) for a patient, wherein the guidewire (11) includes visual indicia (series of indicia, 134) of multiple bands of multiple colors (yellow, orange, red; [0112]; [0026]; Fig. 45A) in proximity to a proximal end (59), aiding in the proper placement by providing a medical professional a visual queue that the distal end of the guidewire is sufficiently located within the kidney; wherein the visual indicia includes multiple bands of multiple colors (yellow, orange, red; [0112]; [0026]; [0142]; [0016]; [0112]; Fig. 45A).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the plurality of proximal indicia disclosed by Wan to include visual indicia of multiple bands of colors, similar to that disclosed by Ayala, in order to provide a more discerning, and visually distinct, indication between the different bands of indicia, as suggested by Ayala in paragraph [0112]; allowing a physician to more readily determine which size stent is necessary, as suggested by Wan in paragraph [0069], by color-code.
Conclusion
9. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Eidenschink (US 6,030,407) discloses a stent delivery system with a sleeve (34) and tab (100) including markings to allow a physician to quickly determine a size and type of stent for patient.
10. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/Primary Examiner, Art Unit 3781