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 Amendment
Claims 2-6 and 11-22 are pending in the application. Claims 1 and 7-10 have been canceled. Claim 2 has been amended.
Claim Objections
Claim 22 objected to because of the following informalities: in line 2, “a distal end” should read --the distal end--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 has been amended to recite “one or more electrodes disposed radially along an inner wall of the suction tip, wherein the one or more electrodes are coupled to conductors disposed within the first lumen…” Claim 21 recites that the suction tip comprises one or more electrodes configured to receive an electrocardiogram signal. It is unclear if the “one or more electrodes” recited in claim 21 are the same “one or more electrodes” as amended in claim 1, or a different “one or more electrodes.” Appropriate correction is required.
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 2-6, 11-13, 15-17, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Eisner et al. (US 2017/0319776 A1) (“Eisner”) in view of Schultz et al. (US 2019/0175891 A1) (“Schultz”), Casarotto (WO 2017/203462 A1), and Kassab et al. (US 2017/0224283 A1) (“Kassab”).
Regarding claims 2 and 11, Eisner discloses (Figures 23A-24B) a device capable of stabilizing a target tissue comprising: an elongate body (1604/1704) comprising a longitudinal axis, a first lumen (1642/1742), and a second lumen (1644/1744); a suction tip (tip at 1640/1740) coupled to the elongate body, wherein the suction tip defines a suction aperture and the suction aperture is in fluid communication with the first lumen to apply suction to the target tissue (paragraphs 0171, 0176); and an injection tip (tip at 1606/1706) coupled to the elongate body proximal of the suction tip, wherein the injection tip comprises an annular aperture at a distal end of the injection tip, wherein the annular aperture extends concentrically over an exterior surface of the suction tip (Figures 23B, 24B), wherein the injection tip is in fluid communication with the second lumen to dispense a fluid (paragraphs 0170, 0175); and wherein the fluid is directed distally when distributed from the injection tip.
Eisner fails to explicitly disclose the fluid is a contrast fluid. Eisner also fails to disclose that the exterior surface of the suction tip is angled away from the longitudinal axis, a distal end of the suction tip is parallel to the longitudinal axis, and the exterior surface of the suction tip is between the distal end of the suction tip and the elongated body. Eisner fails to disclose the suction tip comprises a conical proximal portion and a cylindrical distal portion. Eisner further fails to disclose one or more electrodes disposed radially along an inner wall of the suction tip, wherein the one or more electrodes are coupled to conductors disposed within the first lumen.
In the same field of endeavor, Schultz teaches dispensing a contrast fluid to a vessel or organ lumen in order to enable the vessel or organ to be visualized using fluoroscopy or radiography (paragraph 0024).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Eisner to dispense a contrast fluid, as taught by Schultz. This modification enables the vessel or organ to be visualized using fluoroscopy or radiography (paragraph 0024).
In the same field of endeavor, Casarotto teaches (Figures 3 and 5) a suction conduit (4) comprising an elongate body comprising a longitudinal axis and a suction tip (12). Casarotto teaches the exterior surface (18) of the suction tip is angled away from the longitudinal axis, a distal end (at 20) of the suction tip is parallel to the longitudinal axis, and the exterior surface (18) of the suction tip is between the distal end of the suction tip and the elongated body. Casarotto teaches that the suction tip comprises a conical proximal portion and a cylindrical distal portion (20; page 10, line 21 – page 11, line 3).
PNG
media_image1.png
372
586
media_image1.png
Greyscale
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the exterior surface of the suction tip disclosed by Eisner to be angled away from the longitudinal axis, a distal end of the suction tip to be parallel to the longitudinal axis, the exterior surface of the suction tip to be between the distal end of the suction tip and the elongated body, and the suction tip to comprise a conical proximal portion and a cylindrical distal portion, as taught by Casarotto. These modifications would define a greater useful surface for coupling with a target within the body (Casarotto, page 10, lines 23-25).
Kassab teaches (Figures 27-35) one or more electrodes (500) disposed radially along an inner wall of a suction tip (5040), wherein the one or more electrodes are coupled to conductors (1200) disposed within a first lumen (110) of an elongate body (102). Kassab teaches that the one or more electrodes (500) allow impedance/conductance data (also referred to as bioimpedance data) to be obtained during a procedure (paragraph 0085). Kassab teaches that the conductors allow data obtained using one or more of electrodes to be transmitted to other parts of system, such as to a console (paragraph 0086).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the suction tip taught by Eisner in view of Schultz and Cassarotto to comprise one or more electrodes disposed radially along an inner wall of the suction tip, wherein the one or more electrodes are coupled to conductors disposed within the first lumen, as taught by Kassab. These modifications would allow impedance/conductance data (also referred to as bioimpedance data, e.g., the suction tip coming into contact and engaging tissue) to be obtained during a procedure and the data to be transmitted to other parts of system, such as to a console (Kassab, paragraphs 0085-0086).
Regarding claim 3, Eisner as modified by Schultz, Casarotto, and Kassab teaches the injection tip is fixedly coupled to the suction tip. Eisner discloses (Figures 26A and 26B) that interstitial material can be placed and/or formed between an interior surface of the second lumen and an exterior surface of the first lumen (Eisner, paragraph 0183).
Regarding claim 4, Eisner as modified by Schultz, Casarotto, and Kassab teaches that the injection tip and the suction tip can be integrally formed (e.g., Figures 17A and 17B of Eisner).
Regarding claim 5, Eisner as modified by Schultz, Casarotto, and Kassab teaches (Eisner, Figures 23A-24B) that a distal end of the first lumen extends beyond a distal end of the second lumen (Eisner, paragraphs 0169, 0174).
Regarding claim 6, Eisner as modified by Schultz, Casarotto, and Kassab teaches (Eisner, Figures 23B and 24B) that the injection tip is coaxial and concentric with the suction tip.
Regarding claim 12, Eisner as modified by Schutlz, Casarotto, and Kassab teaches (Eisner, Figures 23A-24B) that the injection tip comprises a cylindrical distal portion, and wherein a diameter of the cylindrical distal portion of the injection tip is about equal to a diameter of the cylindrical distal portion of the suction tip. NOTE: Casarotto teaches (Figure 5) that the inner diameter (22) of the cylindrical distal portion (20) is preferably about 10% greater with respect to the inner diameter (24) of the suction conduit. As modified, the injection tip is concentrically disposed over the suction tip and with a space between for the annular aperture (as disclosed by Eisner). The resulting configuration would provide a cylindrical distal portion of the injection tip that is about equal to a diameter of the cylindrical distal portion of the suction tip.
Regarding claim 13, Eisner as modified by Schultz, Casarotto, and Kassab teaches (Eisner, Figure 26B) that an interstitial material can be placed or formed between an interior surface of the second lumen and an exterior surface of the first lumen, such that the first lumen (1942) has a circular cross-sectional shape (Eisner, Figure 26B) and the second lumen (1944) has a crescent cross-sectional shape (Eisner, Figure 26B).
Regarding claim 15, Eisner as modified by Schultz, Casarotto, and Kassab above teaches the invention substantially as claimed. However, the combined teaching above fails to teach a contrast fluid source coupled to the second lumen.
Schultz further teaches a luer fitting that couples to a fluid contrast source to provide the contrast fluid (paragraphs 0036 and 0041).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify device taught by Eisner in view of Schultz, Casarotto, and Kassab above to have a contrast fluid source coupled to the second lumen, as further taught by Schultz in order supply the contrast fluid during a procedure (Schultz, paragraphs 0036 and 0041).
Regarding claim 16, Eisner as modified by Schultz, Casarotto, and Kassab teaches (Eisner, Figure 6) a handle (110, 148) coupled to a proximal end of the elongate body, wherein the handle comprises a contrast fluid control (paragraphs 0170, 0175) and a vacuum control (110, paragraph 0085).
Regarding claim 17, Eisner as modified by Schultz, Casarotto, and Kassab teaches a wire (106) positioned in the first lumen (Eisner, paragraphs 0170, 0175).
Regarding claim 22, Eisner as modified by Schultz, Casarotto, and Kassab teaches the annular aperture extends to a distal end of the suction tip. NOTE: Figures 23A-23B of Eisner depict embodiments where the suction tip extends past the annular aperture of the injection tip. However, Eisner discloses that the injection tip can extend to a distal end of the suction tip (e.g., see Figures 9A-18B, 20A-22B of Eisner).
Claims 14 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Eisner et al. (US 2017/0319776 A1) (“Eisner”) in view of Schultz et al. (US 2019/0175891 A1) (“Schultz”), Casarotto (WO 2017/203462 A1), and Kassab et al. (US 2017/0224283 A1) (“Kassab”) as applied to claim 2 above, and further in view of Kunis (US 2015/0258270 A1).
Regarding claim 14, Eisner as modified by Schultz, Casarotto, and Kassab teaches a vacuum source operably connected to the first lumen and configured to provide suction at a distal end of the first lumen (Eisner, paragraphs 0092, 0107, 0108, 0169, 0174). However, the combined teaching fails to explicitly teach that the vacuum source is a vacuum pump.
Kunis teaches (Figure 1) that a vacuum pump (28) is a known suction source to provide suction to a distal end of a lumen (paragraph 0038).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the vacuum source taught by Eisner in view of Schutlz, Casarotto, and Kassab to be a vacuum pump, as taught by Kunis. Eisner generically discloses a vacuum source. Kunis specifically teaches that a syringe or a pump is a suitable vacuum source to provide a negative pressure or vacuum to a distal end of a lumen (Kunis, paragraph 0038).
Regarding claim 21, Eisner in view of Schultz, Casarotto, and Kassab teaches the invention substantially as claimed. The combined teaching fails to explicitly teach the suction tip comprises one or more electrodes configured to receive an electrocardiogram signal. However, the combined teaching teaches that the device is adapted to be used in a medical setting. In particular, the device may be used to remove debris or another foreign object (e.g., kidney stone, diseased tissue, and the like) from a patient (not shown). The debris may reside in one or more organs, orifices, or passageways. Accordingly, the device may be utilized in any passageway to assist in removing debris therefrom or adjacent thereto (Eisner, paragraph 0110).
Kunis teaches a suction tip comprising a ring of electrodes capable of receiving an electrocardiogram signal and configured to assist alignment, tissue contact, and identify heart tissue, which may then be employed to enable mapping to be used to identify the proper location to carry out the procedure (paragraphs 0036, 0088).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more electrodes of suction tip taught by Eisner in view of Schultz, Casarotto, and Kassab to be configured to receive an electrocardiogram signal, as taught by Kunis. This modification would assist in alignment and tissue contact of the suction tip during operation of the device during a procedure within the heart (Kunis, paragraph 0036).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Eisner et al. (US 2017/0319776 A1) (“Eisner”) in view of Schultz et al. (US 2019/0175891 A1) (“Schultz”), Casarotto (WO 2017/203462 A1), and Kassab et al. (US 2017/0224283 A1) (“Kassab”) as applied to claim 17 above, and further in view of Miyata et al. (US 5,520,194) (“Miyata”).
Regarding claims 18 and 19, Eisner in view of Schultz, Casarotto, and Kassab teaches the invention substantially as claimed. However, the combined teaching fails to teach that the wire comprises a tapered central portion, wherein the device further comprises a coil positioned around a portion of the wire.
Miyata teaches (Figures 2-7) a guidewire (2) having a tapered central portion (2f) and a coil (3) positioned around a portion of the wire.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the wire taught by Eisner in view of Schultz, Casarotto, and Kassab to have a tapered central portion and a coil positioned around a portion of the wire, as taught by Miyata. These modifications would provide a guide wire that can pass through a body vessel having an extremely small curvature (Miyata, Column 1, lines 58-62).
Regarding claim 20, Eisner in view of Schultz, Casarotto, and Kassab teaches the invention substantially as claimed. However, the combined teaching fails to teach a radiopaque marker ring, wherein a distal end of the wire terminates in the radiopaque marker ring.
Miyata teaches (Figure 4) a guidewire (2) with a radiopaque marker ring (3a), wherein a distal end of the wire (2b) terminates in the radiopaque marker ring.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire taught by Eisner in view of Schultz, Casarotto, and Kassab to have a radiopaque marker ring, wherein a distal end of the wire terminates in the radiopaque marker ring, as taught by Miyata. This modification would allow a position of the guide wire to be easily be detected when fluoroscopy is carried out (Miyata, Column 2, lines 47-52).
Response to Arguments
Applicant’s arguments with respect to claims 2-6 and 11-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The Kassab et al. reference is newly cited.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
Prosecution Insights