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 .
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1. Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ciulla (US 20160166320 A1).
In regards to claim 1, Ciulla discloses a catheter assembly (Abstract discloses a tube system, i.e. catheter), comprising:
(a) a working lumen (Par. 0018 teaches a working lumen); and
(b) a guide configured to position a fragmentizing device within the working lumen, wherein the guide is configured to prevent or minimize any unintended movement of a distal section of the fragmentizing device within the working lumen when the distal section of the fragmentizing device is positioned at a distal end of the working lumen (Par. 0018 teaches that the laser, i.e. fiber, is positioned in the working lumen [114]. Fig 2 shows the distal end of the laser [120] securely positioned in the working lumen [114]).
In regards to claim 2, Ciulla discloses the catheter assembly of claim 1, wherein the working lumen is a vacuum lumen and the guide is configured to be positioned in the vacuum lumen, the guide allows for fluid and debris to flow past the fragmentizing device and through the vacuum lumen for removal of fluid and debris (Par. 0035 and 0039 teaches that the working lumen is in communication with a vacuum source for suctioning the fragments/debris as well as fluid out – see also Par. 0033)
In regards to claim 3, Ciulla discloses the catheter assembly of claim 2, additionally comprises an actuating device for moving the guide in a back-and-forth direction within the vacuum lumen (Par. 0022 teaches using an actuator).
In regards to claim 4, Ciulla discloses the catheter assembly of claim 1, wherein the fragmentizing device comprises a laser fiber and the working lumen is a vacuum lumen (Par. 0004 teaches the laser is passed through a fiber and Par. 0035 teaches that the working lumen is in communication with a vacuum source)
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.
2. Claim(s) 5-19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ciulla in view of Vazales (US 20170258550 A1).
In regards to claim 5, Ciulla discloses the catheter assembly of claim 1, except for wherein the guide comprises: (a) a tubular body having a lumen configured to receive the fragmentizing device and wings extending from a distal end segment of the tubular body for creating flow gaps between the tubular body and an inner side of the working lumen ; (b) an elongated tube having a distal portion comprising one or more curved or bent sections that bias the distal portion of the elongated tube against an inner side of the working lumen; (c) an elongated tube having a distal portion, wherein the distal portion has a cross-sectional perimeter that is not symmetric about a central longitudinal axis of the elongated tube; (d) an elongated tube having a D-shaped, C-shaped, or U-shaped distal portion including a channel extending along the distal portion to accommodate the fragmentizing device; (e) a first mechanical feature that is configured to mechanically engage with a second mechanical feature on an inner side of the working lumen; (f) a magnetic feature that is configured to magnetically engage with a counterpart magnetic feature associated with the working lumen; (g) a ring that is configured to be placed around the distal section of the fragmentizing device; (h) a snare that is configured to receive the distal section of the fragmentizing device and to secure the distal section of fragmentizing device by constricting a loop of the snare; or (i) expandable elements located on an inner side of the working lumen, such that the expansion of the elements secures the distal section of the fragmentizing device.
While Ciulla does teach there being a tubular body having a lumen to receive the fragmenting device (see above rejections), they do not teach the system comprising wings extending from a distal end segment of the tubular body for creating flow gaps between the tubular body and an inner side of the working lumen. However, in the same field of endeavor, Vazales discloses a catheter system for removing debris from a user’s airway (Abstract and Par. 004) wherein the system comprises two to four arms/wings (Par. 0144, since the art of Vazales has the same structure of wings along the tubular body, it would be capable of the claimed function of creating flow gaps) in order to stabilize and center the tubular assembly (Par. 0144 and 0011).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Ciulla and modified them by having the tubular body comprise wings, as taught and suggested by Vazales, in order to stabilize and center the tubular assembly (Par. 0144 and 0011).
In regards to claim 6, Ciulla discloses a kidney stone removal system (Par. 0003 teaches kidney stone removal device), comprising:
(a) a vacuum tube (Par. 0035 and 0039 teaches that the working lumen is in communication with a vacuum source); and
(b) a laser guide configured to be removably inserted into the vacuum tube (Par. 0004 teaches the laser is passed through a fiber), wherein the laser guide comprises
(i) a tubular body having a lumen configured to receive a laser device ((Par. 0018 teaches that the laser, i.e. fiber, is positioned in the working lumen [114]. Fig 2 shows the distal end of the laser [120] securely positioned in the working lumen [114]).
Ciulla does not teach the system comprising wings extending from a distal end segment of the tubular body for creating flow gaps between the tubular body and an inner side of the working lumen.
However, in the same field of endeavor, Vazales discloses a catheter system for removing debris from a user’s airway (Abstract and Par. 004) wherein the system comprises two to four arms/wings (Par. 0144, since the art of Vazales has the same structure of wings along the tubular body, it would be capable of the claimed function of creating flow gaps) in order to stabilize and center the tubular assembly (Par. 0144 and 0011).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Ciulla and modified them by having the tubular body comprise wings, as taught and suggested by Vazales, in order to stabilize and center the tubular assembly (Par. 0144 and 0011).
In regards to claim 7, the combined teachings of Ciulla and Vazales as applied to claim 6 discloses the kidney stone removal system of claim 6, 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 (Ciulla: Fig 2 shows the distal end of the laser [120] securely and fully positioned in the working lumen [114], i.e. tubular body).
In regards to claim 8, the combined teachings of Ciulla and Vazales as applied to claim 6 discloses the kidney stone removal system of claim 6, wherein the guide comprises two to four wings (Par. 0144 of Vazales, see claim 6 rejection).
In regards to claim 9, the combined teachings of Ciulla and Vazales as applied to claim 6 discloses the kidney stone removal system of claim 6, wherein the guide consists of three or four wings and wherein a circumferential distance is the same between each pair of neighboring wings (Par. 0144 of Vazales, see claim 6 rejection. Fig 7a of Vazales also shows the wings having the same circumferential distance between each other).
In regards to claims 10-14, the combined teachings of Ciulla and Vazales as applied to claim 6 discloses the kidney stone removal system of claim 6, 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, wherein the first pair and second pair of neighboring wings share a common wing, wherein at least two of the gaps have different sizes, wherein each wing comprises a middle segment having a rectangular shape which transitions into tapered end segments that slope downward into the tubular body, 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 (Par. 0144 and Fig 7a of Vazales, see claim 6 rejection, teach there being at least 2 wings spaced along a tubular body).
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the wings having different circumferential distances/different gap sizes /sharing common wings/having variable thickness, because Applicant has not disclosed that these arrangements provide an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the wings of Vazales, and applicant' s invention, to perform equally well with either the because both wings would perform the same functions equally well.
Therefore, it would have been prima facie obvious to modify the wings of Vazales to obtain the invention as specified in claims 10-14 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Vazales.
In regards to claim 15, the combined teachings of Ciulla and Vazales as applied to claim 6 discloses the kidney stone removal system of claim 6, wherein each wing has a longitudinal axis that is at an angle relative to a longitudinal axis of the tubular body (Fig 7a of Vazales).
In regards to claim 16, the combined teachings of Ciulla and Vazales as applied to claim 6 discloses the kidney stone removal system of claim 6, additionally comprising an actuator for moving the tubular body within the vacuum tube (Par. 0022 of Ciulla).
In regards to claim 17, the combined teachings of Ciulla and Vazales as applied to claim 6 discloses the kidney stone removal system of claim 16, 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 (Par. 0022 of Ciulla discloses the actuator having a power means and connected to a handle that allows for movement).
In regards to claims 18-19, the combined teachings of Ciulla and Vazales as applied to claim 6 discloses the kidney stone removal system of claim 17, wherein the shaft is configured to be removably coupled to a proximal end of the tubular body or wherein the shaft is permanently attached to a proximal end of the tubular body (Par. 0022 of Ciulla teaches that the handle, i.e. shaft, can be attached to the tube either permanently or by a locking/unlocking adhesive)
In regards to claim 21, the combined teachings of Ciulla and Vazales as applied to claim 16 discloses the kidney stone removal system of claims 16, wherein the actuator comprises a channel for receiving the laser device, the channel configured to be in commutation with the lumen of the tubular body (Fig 1 and Par. 0022 of Ciulla).
Double Patenting
3. 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.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12256989 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they contain the same subject matter.
Claims 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/753460 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain the same subject matter. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
4. Claim 20 does not currently have an art rejection applied. However, the Double Patenting rejection would still need to be addressed. The claim contains subject matter that is not found in the art, such subject matter including “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 configured 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.”
Conclusion
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/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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