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
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 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.
Claims 1 and 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hawkins (US Pub No. 2010/0114065).
Regarding claim 1, Hawkins discloses (Figures 2-4) a catheter (20) for treating occlusions in blood vessels (Paragraphs 0037-0038), comprising: a tubular member (see annotated figure below); a flexible member (26) positioned at a distal end of the catheter (Figure 4), the flexible member forming an enclosure that is fillable with conductive fluid (Paragraphs 0037-0038); and a shock wave emitter assembly (22, 24) supported by the tubular member (Figures 2 and 4) and positioned within the enclosure proximate to a distal end of the flexible member (Figures 2 and 4), wherein when the flexible member is filled with the conductive fluid and an electrical pulse is applied to the shock wave emitter assembly, shock waves are generated that propagate in a distal direction out of the distal end of the catheter (clearly shown in Figure 4) (Paragraphs
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0037-0038).
Regarding claim 1 under an alternative rejection, Hawkins discloses (Figure 5) a catheter (40) for treating occlusions in blood vessels (Paragraphs 0037-0038), comprising: a tubular member (similar to the annotated figure above); a flexible member (46) positioned at a distal end of the catheter (Figure 5), the flexible member forming an enclosure that is fillable with conductive fluid (Paragraphs 0037-0038); and a shock wave emitter assembly (44) supported by the tubular member (Figure 5) and positioned within the enclosure proximate to a distal end of the flexible member (Figure 5), wherein when the flexible member is filled with the conductive fluid and an electrical pulse is applied to the shock wave emitter assembly, shock waves are generated that propagate in a distal direction out of the distal end of the catheter (will be similar to what is shown in Figure 4) (Paragraphs 0037-0038 and 0041).
Regarding claim 12 under any of the rejections for claim 1 above, wherein the conductive fluid comprises saline (Paragraph 0038).
Regarding claim 13 under the second rejection for claim 1, wherein the shock wave emitter assembly is a primary shock wave emitter assembly (44) and the catheter comprises at least one secondary shock wave emitter assembly (42) located within the enclosure proximally of the primary shock wave emitter assembly (clearly shown in Figure 5), wherein the at least one secondary shock wave emitter assembly is configured to generate shock waves that propagate radially outwardly (will be similar to what is shown in Figure 4) (Paragraphs 0037-0038 and 0041).
Regarding claim 14 under the second rejection for claim 1, wherein the at least one secondary shock wave emitter assembly is configured to generate shock waves independently of the primary shock wave emitter assembly (Paragraphs 0037-0038 and 0041).
Regarding claim 15 under the second rejection for claim 1, wherein the at least one secondary shock wave emitter assembly comprises at least one conductive sheath (tip of 42).
Regarding claim 16 under any of the rejections for claim 1 above, wherein the tubular member includes a guide wire lumen (tubular member includes a lumen as shown in Figures 2, 4 and 5 to where a guidewire is fully capable in being inserted).
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 of this title, 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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hawkins (US Pub No. 2010/0114065) as applied to claim 1 above, and further in view of Loeb (US Pub No. 2003/0060813).
Regarding claim 10, Hawkins discloses all of the elements of claim 1 above except for a fluid pump connected to a proximal end of the device configured to provide conductive fluid to fill the flexible member; and a fluid return line having an inlet proximate to the distal end of the catheter and configured to remove the conductive fluid from the flexible member, wherein the fluid pump and fluid return line are configured to circulate the conductive fluid under pressure inside the flexible member.
Loeb, in the analogous art of balloon catheters, teaches (Figures 1-2) a balloon catheter system (10) that includes a fluid pump (22) connected to a proximal end of the device configured to provide conductive fluid (saline, Paragraphs 0047 and 0064) to the volume inside the balloon (16) (clearly shown in Figure 2) (Paragraphs 0046 0055); and a fluid return line (28) having an inlet (26, 27) proximate to the distal end of the device (Figure 1) and configured to remove the conductive fluid from the volume of the balloon (Figures 1-2) (Paragraph 0063), wherein the fluid pump and fluid return line are configured to circulate the conductive fluid under pressure within the volume of the balloon (clearly shown in Figures 1-2) (Paragraphs 0011, 0055 and 0061-0063). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hawkins to have included a fluid pump connected to a proximal end of the device configured to provide the conductive fluid to fill the flexible member; and a fluid return line having an inlet proximate to the distal end of the catheter and configured to remove the conductive fluid from the flexible member as taught by Loeb, in order to provide a cooling system to prevent damage to the interior components of the device and also to the patient’s tissue (Loeb, Paragraphs 0011 and 0053). [Hawkins modified by Loeb as a whole would result in a fluid pump to be connected to a proximal end of the device configured to provide conductive fluid to fill the flexible member; and a fluid return line having an inlet proximate to the distal end of the catheter and configured to remove the conductive fluid from the flexible member, wherein the fluid pump and fluid return line are configured to circulate the conductive fluid under pressure inside the flexible member]
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hawkins (US Pub No. 2010/0114065) and Loeb (US Pub No. 2003/0060813) as applied to claim 10 above, and further in view of Kurth (US Pub No. 2010/0274189).
Regarding claim 11, Hawkins modified by Loeb discloses all of the elements of claim 10 above except for a pressure relief valve at an outlet of the fluid return line.
Kurth, in the analogous art of balloon catheters, teaches (Figure 1) a balloon catheter (10) that includes pressure relief valve (20) at an outlet (22) of a hub (18) (Paragraphs 0035 and 0054). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hawkins modified by Loeb to have included a pressure relief valve at an outlet of the fluid return line as taught by Kurth, in order to regulate the pressure inside the balloon and thereby rendering rupture impossible and making the use of the catheter fail-safe (Kurth, Paragraphs 0035 and 0054).
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 4, 5-7, 10-13 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 5-10 of U.S. Patent No. 10,966,737. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are fully contained within the claim of the patent application.
Claims
19/023,002
1
2
4
5
6
7
10
11
12
13
16
Claims
Patent 10,966,737
1, 10
1, 10
1
2
2
10
5
6
7
8
9
Claims 1, 2, 4, 5-7, 10-13 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 5-11 of U.S. Patent No. 11,602,363. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are fully contained within the claim of the patent application.
Claims
19/023,002
1
2
4
5
6
7
10
11
12
13
16
Claims
Patent 11,602,363
1, 11
1, 11
1, 11
1, 11
2
7
5
6
8
9
10
Claims 1-12 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 10-13 and 5-11 of U.S. Patent No. 11,950,793. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are fully contained within the claim of the patent application.
Claims
19/023,002
1
2
3
4
5
6
7
8
9
10
11
12
16
Claims
Patent 11,950,793
1
1
2
3
4
5
11
12
13
6
7
8
10
Allowable Subject Matter
Claims 2-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and also, if they overcome the double patenting rejection set forth in this Office Action.
The following is an examiner’s statement of reasons for indicating allowable subject matter in the dependent claims:
The prior art of record fails to disclose or render obvious the combination of features as claimed. In particular, the prior art of record fails to disclose wherein the shock wave emitter assembly comprises: first and second wires extending along at least a portion of the tubular member; and a conductive sheath extending around the first and second wires such that a first spark gap is formed between the conductive sheath and a distal face of the first wire and a second spark gap is formed between the conductive sheath and a distal face of the second wire, wherein the shock waves are generated at the first and second spark gaps (claim 2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAJID JAMIALAHMADI/Primary Examiner, Art Unit 3771
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