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 Objections
Claims 4-5, 10-13, 15-16, 25-27, and 31 are objected to because of the following informalities:
Claim 4, line 1, “distal” should be inserted before “tip”.
Claim 4, line 2, “distal” should be inserted before “tip”.
Claim 10, line 1, “the” should be inserted before “conductive fluid”.
Claim 12, line 1, “the” should be inserted before “conductive fluid”.
Claim 13, line 1, “the” should be inserted before “voltage”.
Claim 15, line 3, “gap” should read “gaps”.
Claim 19, line 1, “the” before “voltage” should be deleted.
Claim 25, line 1, “the” should be inserted before “conductive fluid”.
Claim 27, line 1, “the” should be inserted before “conductive fluid”.
Claim 31, line 1, “the” should be deleted before “voltage”.
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.
Claims 17-37 are 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 17 recites the limitation "the distal tip" in line 3. There is insufficient antecedent basis for this limitation in the claim. The limitation should read “a distal tip”.
Claim 17 recites the limitation "the distal tip" in line 4. There is insufficient antecedent basis for this limitation in the claim. The limitation should read “a distal tip”.
Claim 17 recites the limitation "the distal ends" in line 5. There is insufficient antecedent basis for this limitation in the claim. The limitation should read “distal ends”.
Claim 17 recites the limitation "the proximal end" in line 8. There is insufficient antecedent basis for this limitation in the claim. The limitation should read “a proximal end”.
Claim 29 recites the limitation "the proximal end" in line 11. There is insufficient antecedent basis for this limitation in the claim. The limitation should read “a proximal end”.
Claim 29 recites the limitation "the distal tips" in line 11. There is insufficient antecedent basis for this limitation in the claim. The limitation should read “distal tips”.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 1-6, 9-13, 17-19, 22, 25-27, 29-31, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0360482 (Nguyen ‘482).
1. A catheter (shock wave device 100) comprising:
a central tube (inner member 104);
an emitter assembly mounted over the central tube (FIG. 1; P0022), wherein the emitter assembly comprises:
a conductive sheath (band 108);
a first insulated wire (first wire 106); and
a second insulated wire (second wire 106),
wherein a distal portion of the first insulated wire (wire end 202) and a distal portion of the second insulated wire (wire end 202) are positioned within the conductive sheath (FIG. 1-2; P0022), and
wherein the emitter assembly is configured to generate a plurality of cavitation bubbles or shock waves when a pulsed voltage is applied to the emitter assembly (P0022); and
an outer tube (covering 102) housing the emitter assembly,
wherein the outer tube is configured to receive a conductive fluid (P0022),
wherein the outer tube comprises a distal opening for releasing the plurality of cavitation bubbles or shock waves and the conductive fluid in a forward direction to treat thrombus at a treatment site (FIG. 1-2; P0022).
2. When the pulsed voltage is applied across the first insulated wire and the second insulated wire, a current is configured to:
flow from the first insulated wire to the conductive sheath to generate a first plurality of cavitation bubbles or shock waves (FIG. 2; P0025) and,
flow from the conductive sheath to the second insulated wire to generate a second plurality of cavitation bubbles or shock waves (FIG. 2; P0025).
3. The first insulated wire comprises a first exposed distal tip (wire end 202) and the second insulated wire comprises a second exposed distal tip (wire end 202).
4. The current is configured to flow from the first exposed tip to the conductive sheath and from the conductive sheath to the second exposed tip via a conductive fluid (P0022 and P0025).
5. The current is configured to flow from the first exposed distal tip to an inner wall and/or front edge of the conductive sheath (FIG. 2).
6. The central tube (e.g., combination of inner member 104 and insulating sheath 110) comprises a first segment (distal end of inner member 104) and a second segment (combination of inner member 104 and insulating sheath 110) closer to a proximal end of the central tube than the first segment, where the diameter of the second segment is larger than the first segment (FIG. 2).
9. The central tube comprises a central lumen for accommodating a guide wire (guide wire 114)(FIG. 2).
10. A pump is configured to deliver a continuous flow of conductive fluid to the emitter assembly through the outer tube (P0030).
11. The conductive fluid comprises saline (P0022).
12. The continuous flow of conductive fluid flushes (or is at least capable of flushing) debris away from the treatment site (P0022).
13. The voltage is between 800V and 2700V (e.g., 100V to 10000V at P0021).
17. A catheter (shock wave device 100) for treating a thrombus in a blood vessel (Abstract) comprising:
an elongated central member (inner member 104);
a first insulated wire (first wire 106) extending along the central member (FIG. 1-2), wherein a distal tip (wire end 202) of the first wire is not insulated (FIG. 1-2; P0022 and P0025);
a second insulated wire (second wire 106) extending along the central member (FIG. 1-2), wherein a distal tip (wire end 202) of the second wire is not insulated (FIG. 1-2; P0022 and P0025);
a cylindrical conductive shield (band 108) positioned around and spaced from the distal ends of the first and second insulated wires (FIG. 2); and
an outer tube (covering 102) surrounding the cylindrical conductive shield and having an open distal end configured so that conductive fluid injected into the proximal end of the outer tube will pass over the distal tips of the first and second insulated wires and be directed out the distal end of the outer tube towards the thrombus (FIG. 1-2; P0022) and wherein when high voltage pulses are applied across the first and second insulated wires, current will flow along the first insulated wire and jump a first gap between the distal tip of the first insulated wire to the cylindrical conductive shield and then along the cylindrical conductive shield and then jump a second gap between the cylindrical conductive shield and the distal tip of the second insulated wire and back along the second insulated wire to create, at both the first and second gaps, cavitation bubbles or shock waves that are forwardly directed toward the thrombus (FIG. 1-2; P0025).
18. The central member includes a lumen for accommodating a guide wire (guide wire 114).
19. The voltage of the high voltage pulses is between 800V and 2700V (e.g., 100V to 10000V at P0021).
22. The central tube (e.g., combination of inner member 104 and insulating sheath 110) comprises a first segment (distal end of inner member 104) and a second segment (combination of inner member 104 and insulating sheath 110) closer to a proximal end of the central tube than the first segment, where the diameter of the second segment is larger than the first segment (FIG. 2).
25. A pump is configured to deliver a continuous flow of conductive fluid into the proximal end of the outer tube (P0030).
26. The conductive fluid comprises saline (P0022).
27. The continuous flow of the conductive fluid flushes (or is at least capable of flushing) debris away from the thrombus (P0022).
29. A catheter (shock wave device 100) for treating a thrombus in a blood vessel (Abstract) comprising:
an elongated central member (inner member 104);
a first insulated wire (first wire 106) extending along the central member and electrically connected at its distal end (wire end 202) to a first electrode pair (e.g., first wire end 202 and band 108);
a second insulated wire (second wire 106) extending along the central member and electrically connected at its distal end (wire end 202) to a second electrode pair (e.g., second wire end 202 and band 108);
a cylindrical conductive shield (band 108) positioned around and spaced from the distal ends of the first and second insulated wires (FIG. 1-2), wherein the cylindrical conductive shield forms an electrode of the first electrode pair and an electrode of the second electrode pair (FIG. 1-2; P0022); and
an outer tube (covering 102) surrounding the cylindrical conductive shield and having an open distal end configured so that conductive fluid injected into the proximal end of the outer tube will pass over the distal tips of the first and second insulated wires and be directed out the distal end of the outer tube towards the thrombus (FIG. 1-2; P0022 and P0025) and wherein when high voltage pulses are applied across the first and second insulated wires, current will flow along the first insulated wire and jump a first gap of the first electrode pair and then along the cylindrical conductive shield and then jump a second gap of the second electrode pair and back along the second insulated wire to create, at both the first and second gaps, cavitation bubbles or shock waves that are forwardly directed toward the thrombus (FIG. 1-2; P0025).
30. The central member includes a lumen for accommodating a guide wire (guide wire 114).
31. The voltage of the high voltage pulses is between 800V and 2700V (e.g., 100V to 10000V at P0021).
35. The central tube (e.g., combination of inner member 104 and insulating sheath 110) comprises a first segment (distal end of inner member 104) and a second segment (combination of inner member 104 and insulating sheath 110) closer to a proximal end of the central tube than the first segment, where the diameter of the second segment is larger than the first segment (FIG. 2).
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 7, 23, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0360482 (Nguyen ‘482), as applied above, and further in view of US 2019/0150960 (Nguyen ‘960).
Nguyen ‘482 discloses the invention substantially as claimed as discussed above but does not disclose the second segment having a longitudinal groove. Nguyen ‘960 teaches a catheter in the same field of endeavor having a second segment with a longitudinal groove (groove 260, 262, 264, 268)(FIG. 2A; P0035) for accommodating a part of the first insulated wire (P0035) for the purpose of limiting the cross-sectional profile of the catheter while promoting ease of construction, configuration, and operation (FIG. 2A; P0035 and P0072). 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 catheter of Nguyen of ‘482 to include a second segment longitudinal groove as taught by Nguyen ‘960 in order to limit the cross-sectional profile of the catheter while promoting ease of construction, configuration, and operation
Claim(s) 14, 20, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0360482 (Nguyen ‘482), as applied above, and further in view of US 2019/0388110 (Nguyen ‘110).
Nguyen ‘482 discloses the invention substantially as claimed as discussed above but does not disclose the repetition rates of the applied voltage pulses. Nguyen ‘110 teaches a catheter in the same field of endeavor having repetition rates of applied voltage pulses being between 4 Hz and 100 Hz (e.g., 14 Hz and 200 Hz at P0032) for the purpose of minimizing shock wave strength and maximizing bubble growth and collapse (P0032). 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 catheter of Nguyen of ‘482 to have a repetition rate of the applied voltage pulse be between 4 Hz and 100 Hz as taught by Nguyen ‘110 in order to minimize shock wave strength and maximize bubble growth and collapse.
Claim(s) 15, 16, 21, 28, 33, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0360482 (Nguyen ‘482), as applied above.
Nguyen ‘482 discloses the invention substantially as claimed as discussed above and further discloses a first spark gap between a distal end of the first insulated wire and the conductive sheath and a second spark gap between a distal end of the second insulated wire and the conductive sheath (FIG. 1-2; P0022 and P0025) but is silent regarding the dimension of the gaps such that it does not disclose the gaps being between 0.003 inches and 0.006 inches or the first gap being less than 0.005 inches. 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 dimension of the spark gaps of Nguyen ‘482 to be between 0.003 inches and 0.006 inches or the first gap to be less than 0.005 inches since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Nguyen ‘482 would not operate differently with the claimed dimensions since Nguyen ‘482 discloses first and second spark gaps thereby functioning appropriately having the claimed value. Further, applicant places no criticality on the range claimed, indicating the value “In some embodiments” (see P0032 and P0037).
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.
Claim 1-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,992,232 (Nguyen ‘232). Although the claims at issue are not identical, they are not patentably distinct from each other because Nguyen ‘232 claims:
US App. # 18/642,498
Nguyen ‘232
Claim 1
Claim 1
Claim 2
Claim 2
Claim 3
Claim 3
Claim 4
Claim 4
Claim 5
Claim 5
Claim 6
Claim 6
Claim 7
Claim 7
Claim 8
Claim 8
Claim 9
Claim 9
Claim 10
Claim 10
Claim 11
Claim 11
Claim 12
Claim 12
Claim 13
Claim 13
Claim 14
Claim 14
Claim 15
Claim 15
Claim 16
Claim 15
Claim 17
Claim 18 or 1
Claim 18
Claim 20 or 9
Claim 19
Claim 21 or 13
Claim 20
Claim 14
Claim 21
Claim 15
Claim 22
Claim 6
Claim 23
Claim 7
Claim 24
Claim 18 or 1
Claim 25
Claim 10
Claim 26
Claim 11
Claim 27
Claim 12
Claim 28
Claim 15
Claim 29
Claim 18 or 1
Claim 30
Claim 9
Claim 31
Claim 13
Claim 32
Claim 14
Claim 33
Claim 15
Claim 34
Claim 15
Claim 35
Claim 6
Claim 36
Claim 7
Claim 37
Claim 18 or 1
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771
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