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 .
The current application has the priority date of 09/29/2022 according to the priority chain on the record.
Response to Arguments (regarding Restriction/election requirement)
Applicant’s election without traverse of Invention I (Claims 1-18 and amended claims 19-20) in the reply filed on 03/26/2026 is acknowledged.
However, with regard to the Species election, the Applicant responded with traverse to the following:
To Species A (pertaining to claims 3-7 and 18): the Applicant argues that the numbers of wings as identified in these claims overlap and thus there is no search burden. The Examiner respectfully disagrees, the subcombination of 2 wings (i.e. claim 18) does not overlap with the combination of 4 wings (i.e. claims 3-7). Claims 3, 4 and 5-7 disclose a range of different number of wings in which all of these claims disclose an overlap of 4 wings; however, claim 18 distinctly discloses only 2 wings. Based on the Applicant’s arguments and in view of further consideration, claim 18 is withdrawn from examination.
To Species B (pertaining to claims 8-10): the applicant elects claim 8, with traverse; claims 9 and 10 are withdrawn from examination.
To Species C (pertaining to claims 13-14): the applicant elects claim 14, with traverse; claim 13 is withdrawn from examination.
To Species D (pertaining to claims 12-17): after further consideration of the Applicant’s arguments; claim 15 is withdrawn from examination.
In summary, claims 1-8, 11-12, 14, 16-17 and 19-20 are examined, and claims 9-10, 13, 15, and 18 are withdrawn in view of restriction/election requirement.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Note: Claims 9-10, 13, 15, and 18 are withdrawn from consideration due to restriction/election requirement above. However, in order to avoid confusion with dependency, all claims are considered below for this double patenting rejection only.
Claims 1-2 and 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-20 of U.S. Patent No. 12,256,989. Although the claims at issue are not identical, they are not patentably distinct from each other because Pat’989 discloses an invention that fully encompasses the invention of the current application, see overlapping unlined limitations as follows:
Current application: 18/753460
US Pat. No. 12,256,989
1. (Original) A kidney stone removal system, comprising:
(a) a vacuum tube; and
(b) a laser guide conFig.d to be removably inserted into the vacuum tube, wherein the laser guide comprises
(i) a tubular body having a lumen conFig.d to receive a laser device, and
(ii) wings extending from a distal end segment of the tubular body for guiding the distal end segment of the tubular body in the vacuum tube and creating flow gaps between the tubular body and the vacuum tube.
Note: “vacuum tube” in this application is analogous to “vacuum tube (lumen)” or “vacuum lumen” in US Pat 12,256,989
1. A kidney stone removal system, comprising:
(a) a kidney stone removal catheter conFig.d for insertion into a kidney for treatment of kidney stone, the kidney stone removal catheter comprising an irrigation lumen and a vacuum tube lumen, wherein the irrigation lumen communicates with a plurality of irrigation ports and the vacuum lumen is conFig.d and sized for suction of a kidney stone or fragments of a kidney stone; and
(b) a laser guide conFig.d to be removably inserted into the vacuum lumen, wherein the laser guide comprises
(i) a tubular body having distal and proximal opposing open ends and a lumen extending between the opens ends, wherein the lumen is conFig.d to receive a laser device for fragmenting a kidney stone, and
(ii) wings extending from a distal end segment of the tubular body for guiding the distal end segment of the tubular body in the vacuum lumen and creating flow gaps between the tubular body and an inner sidewall of the vacuum lumen such that the flow gaps are sized to allow suction of the kidney stone or fragments of the stone created by the laser device.
2. (Original) The kidney stone removal system of claim 1, wherein the tubular body is conFig.d to not extend out of a distal end of the vacuum tube when the tubular body is inserted completely into the vacuum tube and placed in an operational position.
2. The kidney stone removal system of claim 1, wherein the tubular body is conFig.d to not extend out of a distal end of the vacuum lumen when the tubular body is inserted completely into the vacuum lumen and placed in an operational position.
3. The kidney stone removal system of claim 1, wherein the guide consists of two wings to allow for the flow gaps to be of an adequate size for removal of the kidney stone or fragments of the stone created by the laser device.
4. (Original) The kidney stone removal system of claim 1, wherein the guide consists of three or four wings and wherein a circumferential distance is the same between each pair of neighboring wings.
4. The kidney stone removal system of claim 1, wherein the guide consists of three or four wings and wherein a circumferential distance is the same between each pair of neighboring wings.
5. (Original) The kidney stone removal system of claim 1, wherein the guide consists of three or four wings and wherein a circumferential distance between a first pair of the neighboring wings is different from a circumferential distance between a second pair of neighboring wings.
5. The kidney stone removal system of claim 1, wherein the guide consists of three or four wings and wherein a circumferential distance between a first pair of the neighboring wings is different from a circumferential distance between a second pair of neighboring wings.
6. (Original) The kidney stone removal system of claim 5, wherein the first pair and second pair of neighboring wings share a common wing.
6. The kidney stone removal system of claim 5, wherein the first pair and second pair of neighboring wings share a common wing.
7. (Original) The kidney stone removal system of claim 1, wherein at least two of the gaps have different sizes.
7. The kidney stone removal system of claim 1, wherein at least two of the gaps have different sizes.
9. (Original) The kidney stone removal system of claim 1, wherein each wing has a variable thickness that increases from a proximal end of the wing to a distal end of the wing along a longitudinal axis.
8. The kidney stone removal system of claim 1, wherein each wing has a variable thickness that increases from a proximal end of the wing to a distal end of the wing along a longitudinal axis.
10. (Original) The kidney stone removal system of claim 1, wherein each wing has a longitudinal axis that is at an angle relative to a longitudinal axis of the tubular body.
9. The kidney stone removal system of claim 1, wherein each wing has a longitudinal axis that is at an angle relative to a longitudinal axis of the tubular body.
11. (Original) The kidney stone removal system of claim 1, additionally comprising an actuator for moving the tubular body within the vacuum tube.
10. The kidney stone removal system of claim 1, additionally comprising an actuator for moving the tubular body within the vacuum lumen.
12. (Original) The kidney stone removal system of claim 11, wherein the actuator comprises:(a) a biasing element; and(b) a shaft coupled to the tubular body, such that actuation of the biasing element causes the shaft to move the tubular body in a back-and-forth direction within the vacuum tube.
11. The kidney stone removal system of claim 10, wherein the actuator comprises: (a) a biasing element; and (b) a shaft coupled to the tubular body, such that actuation of the biasing element causes the shaft to move the tubular body in a back-and-forth direction within the vacuum lumen.
13. (Original) The kidney stone removal system of claim 12, wherein the shaft is conFig.d to be removably coupled to a proximal end of the tubular body.
12. The kidney stone removal system of claim 11, wherein the shaft is conFig.d to be removably coupled to a proximal end of the tubular body.
14. (Original) The kidney stone removal system of claim 12, wherein the shaft is permanently attached to a proximal end of the tubular body.
13. The kidney stone removal system of claim 11, wherein the shaft is permanently attached to a proximal end of the tubular body.
15. (Original) The kidney stone removal system of claim 12, wherein the biasing element comprises a band coupled to a distal section of the shaft, and wherein the actuator additionally comprises a cylindrical housing coupled to the band and conFig.d to receive the shaft, such that an inward compression and release of the band causes a part of the shaft to telescopically move into and out from the cylindrical housing.
14. The kidney stone removal system of claim 11, wherein the biasing element comprises a band coupled to a distal section of the shaft, and wherein the actuator additionally comprises a cylindrical housing coupled to the band and conFig.d to receive the shaft, such that an inward compression and release of the band causes a part of the shaft to telescopically move into and out from the cylindrical housing.
17. (Currently amended) The kidney stone removal system of claim 12, wherein the biasing element actuator comprises a first lever coupled to a second lever via a fulcrum bar.
15. The kidney stone removal system of claim 10, wherein the actuator comprises a first lever coupled to a second lever via a fulcrum bar.
18. (Original) The kidney stone removal system of claim 1, wherein the guide comprises two wings.
16. The kidney stone removal system of claim 1, wherein the guide comprises two wings.
8 (Original) (incorporating limitations from claim 1) The kidney stone removal system of claims 1, wherein each wing comprises a middle segment having a rectangular shape which transitions into tapered end segments that slope downward into the tubular body.
17. A kidney stone removal system, comprising: (a) a vacuum lumen; and (b) a laser guide conFig.d to be removably inserted into the vacuum lumen, wherein the laser guide comprises (i) a tubular body having a lumen conFig.d to receive a laser device, and (ii) wings extending from a distal end segment of the tubular body for guiding the distal end segment of the tubular body in the vacuum lumen and creating flow gaps between the tubular body and an inner side wall of the vacuum lumen, wherein each wing comprises a middle segment having a rectangular shape which transitions into tapered end segments that slope downward into the tubular body.
16. (Original) (incorporating limitations from claims 1 and 11) The kidney stone removal system of claims 11, wherein the actuator comprises a channel for receiving the laser device, the channel conFig.d to be in communication with the lumen of the tubular body.
18. A kidney stone removal system, comprising: (a) a vacuum lumen; and (b) a laser guide conFig.d to be removably inserted into the vacuum lumen, wherein the laser guide comprises (i) a tubular body having a lumen conFig.d to receive a laser device, (ii) wings extending from a distal end segment of the tubular body for guiding the distal end segment of the tubular body in the vacuum lumen and creating flow gaps between the tubular body and an inner side wall of the vacuum lumen, and (c) an actuator for moving the tubular body within the vacuum lumen wherein the actuator comprises a channel for receiving the laser device, the channel having a distal end conFig.d to be in communication with the lumen of the tubular body and a proximal end conFig.d to be in communication with a port of a handle device used for the operation of the kidney stone removal system.
19 (incorporating claim 1). (Currently amended) The kidney stone removal system of claim 1 additionally, comprising: (d) a vision feature.
19. A kidney stone removal system, comprising: (a) a kidney stone removal ureteroscope having a vacuum lumen for removal of kidney stone and irrigation channels for application of irrigation fluid; and (b) a laser guide conFig.d to be removably inserted into the vacuum lumen, wherein the laser guide comprises (i) a tubular body having a lumen conFig.d to receive a laser fiber, and (ii) two wings extending from a distal end segment of the tubular body for guiding the distal end segment of the tubular body in the vacuum lumen and creating flow gaps between the tubular body and an inner sidewall the vacuum lumen; and (c) a vision feature incorporated into a distal end of the ureteroscope.
20. (Original) The kidney stone removal system of claim 19, further comprising an actuator for moving the tubular body back and forth within the vacuum tube
20. The kidney stone removal system of claim 19, further comprising an actuator for moving the tubular body back and forth within the vacuum lumen.
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, 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.
Claims 1-4, 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Vazales US 2017/0258550 (hereinafter “Vazales”).
Regarding claim 1, Vazales discloses a kidney stone removal system, (“kidney stone removal” in the claim is treated as intended use. Alternatively, it would have been obvious to scale the device down for use in smaller spaces, e.g. kidney. The device can be scaled down and function in the same manner, yielding predictable results. See In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device). comprising:
(a) a vacuum tube; (This limitation is interpreted as tube for any purpose because the claim does not set forth a vacuum source. Figs. 1,3b show a tube 101. However, at least [0083] teaches that a suction device can be attached to the tube if desired and thus can be used for suctioning)
(b) a laser guide (This limitation is interpreted as guide, because the claim does not set forth a laser; visualization scope 128) configured be removably inserted into the vacuum tube (tube 101), wherein the laser guide comprises
(i) a tubular body (visualization tube 122) having a lumen configured to receive a laser device, (Fig. 3b shows a tube 122, and [0008] teaches a fiber optic which transmits laser energy and [0111] teaches a laser source)
(ii) wings extending from a distal end segment of the tubular body for guiding the distal end segment of the tubular body in the vacuum tube and creating flow gaps between the tubular body and the vacuum tube. (Fig. 3b shows wings/centering assembly 144 extending from the tube 122; see also [0088, 0011]. Also see alternative embodiments Figs. 6A-6C:144, Figs. 7A-7C:174, 177 and Figs. 8B-8E: 184,187)
Regarding claim 2, Vazales discloses the kidney stone removal system of claim 1, wherein the tubular body is configured to not extend out of a distal end of the vacuum tube when the tubular body is inserted completely into the vacuum tube and placed in an operational position. ([0008] teaches wings and states that the inner tube is stabilized inside the outer tube, and thus cannot move)
Regarding claim 3, Vazales discloses the kidney stone removal system of claim 1, wherein the guide comprises two to four wings. ([0144] “…a visualization tube (e.g. 122) can include more than four arms, wings, or tines, as desired or required”) It would have been a design choice to a person of ordinary skill in the art at the time of invention to modify Vazales to contain any number of wings, e.g. two or three wings or more, because it is within the scope to do so, see Vazales [0144] “a visualization tube (e.g. 122) can include more than four arms, wings, or tines, as desired or required.”
Regarding claim 4, Vazales discloses the kidney stone removal system of claim 1, wherein the guide consists of three or four wings and wherein a circumferential distance is the same between each pair of neighboring wings. ([0144] teaches 120 degree separation of the wings)
Regarding claim 8, Vazales discloses the kidney stone removal system of claims 1, wherein each wing comprises a middle segment having a rectangular shape which transitions into tapered end segments that slope downward into the tubular body. (See Fig. 7D exemplary fin 177 has a rectangular mid-section with tapered end segments.)
Regarding claim 19, Vazales discloses the kidney stone removal system of claim 1, additionally, comprising: (d) a vision feature. ([0095-0106] teaches a visualization member 103, light source 104, etc.)
Claims 11-14, 16-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Vazales US 2017/0258550 as applied to claims 1 above, and in view of Rydell et al (5,258,006).
Regarding claim 11, Vazales discloses the kidney stone removal system of claim 1, does not disclose additionally comprising an actuator for moving the tubular body within the vacuum tube. Rydell, a prior art reference in instrument for cauterizing blood vessels, comprising a handle, knob, outer tube, and inner tube (Abstract and Fig. 1); specifically, Vazales teaches an actuator, for effecting translational movement of an inner tube (Abstract). It would have been obvious to modify Vazales to include the actuator means of Rydell; the motivation for doing so is to more easily move the inner tube into proper location inside the outer tube, in a predictable manner.
Regarding claim 12, Vazales in view of Rydell discloses the kidney stone removal system of claim 11, wherein the actuator comprises: (a) a biasing element; and a shaft coupled to the tubular body, such that actuation of the biasing element causes the shaft to move the tubular body in a back-and-forth direction within the vacuum tube. (see rejection to claim 11, and also Rydell: Fig. 1 and col 6:28-47 of which teaches biased scissor style handles that cause the translational movement)
Regarding claim 13, Vazales in view of Rydell discloses the kidney stone removal system of claim 12, wherein the shaft is configured to be removably coupled to a proximal end of the tubular body. (See rejection to claim 12 above, and Rydell: Fig. 1; attachment has to be made in order to for the inner tube to be moved relative to the outer tube)
Regarding claim 14, Vazales in view of Rydell discloses the kidney stone removal system of claim 12, neither Vazales nor Rydell discloses wherein the shaft is permanently attached to a proximal end of the tubular body. However, to make the attachment permanent is considered to be an obvious design choice yielding predictable results. Such attachment would obviate having to reattach the device for every movement)
Regarding claim 16, Vazales in view of Rydell discloses the kidney stone removal system of claims 11, neither Vazales nor Rydell discloses wherein the actuator comprises a channel for receiving the laser device, the channel configured to be in communication with the lumen of the tubular body. However, such is considered to have been obvious since the laser fiber optic exits from the proximal end of the tube.
Regarding claim 17, Vazales in view of Rydell discloses the kidney stone removal system of claim 11, wherein the actuator comprises a first lever coupled to a second lever via a fulcrum bar. (see Rydell: Fig. 1 shows a pivot pin 75)
Regarding claim 20, Vazales discloses the kidney stone removal system of claim 19, but does not disclose further comprising an actuator for moving the tubular body back and forth within the vacuum tube. Rydell, a prior art reference in instrument for cauterizing blood vessels, comprising a handle, knob, outer tube, and inner tube (Abstract and Fig. 1); specifically, Vazales teaches an actuator, for effecting translational movement of an inner tube (Abstract). It would have been obvious to modify Vazales to include the actuator means of Rydell; the motivation for doing so is to more easily move the inner tube into proper location inside the outer tube, in a predictable manner.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: KR 102167406 A1 teaches a device comprising an outer tube and an inner tube, wherein the innertube comprises a plurality of fins/wings to stabilize the innertube within the outer tube; various embodiments shown in Figs. 5-28.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
May 29, 2026
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