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
In response to the amendment filed on 03/02/2026, Claims 3-6, 11-13, 17-20, and 25-27 have been cancelled, and Claims 1, 2, 7-10, 14-16, 21-24, 28-32 and newly added Claim 33 are pending. In response to the claim amendments, the previous claim objections of Claim 24 has been obviated. In response to the claim amendments, the previous claim rejection of Claim 10 has been obviated.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 15, and 29 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.
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.
Claim(s) 1, 2, 7-10, 14-16, 21-24, 28-30, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams (US PGPub 2014/0005576) in view of Flores (US PGPub 2022/0183738) in view of Liprie (US Patent 6,234,952).
Regarding Claim 1, Adams teaches a catheter for treating a stenosis in a body lumen (abstract), the catheter comprising:
an elongated tube (21; Figure 1; Paragraph 0050);
at least one shock wave generator (40) comprising at least one electrode pair (46/24; Figure 1; Paragraph 0051-0052);
at least one balloon (26; Figure 1) sealed to a distal end of the elongated tube (21) and surrounding the at least one shock wave generator (40) (Figure 1; Paragraph, the at least one balloon (21) fillable with a conductive fluid (saline; Paragraph 0050);
Adams fails to disclose:
at least one channel that permits blood to flow through the body lumen past the at least one balloon while the at least one balloon is inflated, wherein the at least one balloon comprises a plurality of lobes that extend outwardly from the elongated tube, and wherein the at least one channel is defined by spacing between the plurality of lobes of the at least one balloon, wherein a cross sectional area of the body lumen occupied by the plurality of lobes of the at least one balloon is less than a cross-sectional area of the body lumen corresponding to the spacing between the plurality of lobes of the at least one balloon.
Flores teaches a catheter for treating a stenosis in a body lumen (abstract) comprising:
an elongated tube (102; Figure 1; Paragraph 0045)
an energy source (124; Figure 1; Paragraph 0063)
at least one balloon (204A-C; Figures 2B; Paragraph 0096) (304A; Figure 3B; Paragraph 0104-0105)
at least one channel (260; Figure 2B) (360; Figure 3B) that permits blood to flow through the body lumen past the at least one balloon while the at least one balloon (304A) is inflated (Paragraph 0101 and 0109), wherein the at least one balloon (304A) comprises a plurality of lobes (304L1, 304L2, 304L3) that extend outwardly from the elongated tube (102; Figure 3B; Paragraph 0104-0105), and wherein the at least one channel (360; Figure 3B) is defined by spacing between the plurality of lobes (304L1-L3) of the at least one balloon (304A), wherein a cross sectional area of the body lumen (108; Figure 3B) occupied by the plurality of lobes (304L1-L3) of the at least one balloon (304A) is less than a cross-sectional area of the body lumen (108; Figure 3B) corresponding to the spacing between the plurality of lobes (304L1-L3) of the at least one balloon (304A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention modify the shockwave balloon catheter of Adams to include at least one channel that permits blood flow past the balloon while the balloon is inflated, as taught by Flores, for the advantage of enabling continued blood flow while treatment therapy is being applied (Paragraph 0109; Flores).
The combination of references fails to explicitly disclose:
wherein a cross sectional area of the body lumen occupied by the plurality of lobes of the at least one balloon is less than a cross-sectional area of the body lumen corresponding to the spacing between the plurality of lobes of the at least one balloon.
Liprie teaches a catheter for treating a stenosis in a body lumen (abstract) comprising
an elongated tube (12; Figures 5-10)
a balloon (41; Figures 5-10) sealed to the distal end of the elongated tube (12), wherein the balloon comprises a plurality of lobes (44, 46, 48; Figures 7-9 and Figures 9-10) that extend outwardly from the elongated tube (12) (see Column 5, Lines 55-58), and
at least one channel (space between lobes 44, 46, 48) that permits blood to flow through the body lumen past the at least one balloon (41) while the at least one balloon is inflated (Column 6, Lines 1-4), and wherein the at least one channel is defined by spacing between the plurality of lobes of the at least one balloon (Column 6, Lines 1-4),
wherein a cross sectional area of the body lumen occupied by the plurality of lobes (44-48) of the at least one balloon (41) is less than a cross-sectional area of the body lumen corresponding to the spacing between the plurality of lobes (44-48) of the at least one balloon (41) (Column 6, Lines 1-4 clearly state that when the centering balloon 41 is inflated, 30-50% of the passageway is blocked and thus it’s the Examiner’s position that 30-49% means that the balloon takes up less cross-sectional area than the spacing between the balloons, as presently claimed).
It would have been obvious to one of ordinary skill in the art to modify the combination of references disclosed above such that the plurality of lobes have a cross-sectional area less than the spacing between the lobes, taught by Liprie, for the advantage of allowing sufficient perfusion of bodily fluids during the time when the balloon is inflated (see Column 5, Lines 55-58; Liprie).
Regarding Claim 2, the combination of references disclosed above teaches the catheter of claim 1, wherein Liprie teaches the at least one channel permits blood to flow through the body lumen at a flow rate that is at least 50% of a normal flow rate of blood through the body lumen without the catheter positioned in the body lumen ((Column 6, Lines 1-4).
Regarding Claim 7, the combination of references disclosed above teaches the catheter of claim 1, wherein Flores teaches the catheter comprises a plurality of balloons (204A-204C; Figure 2B) and a plurality of shock wave generators (222D; Paragraph 0099), each balloon of the plurality of balloons being sealed to a region of the elongated tube (Paragraph 0098-0099) and surrounding one or more of the plurality of shock wave generators (222D; Figure 2B), wherein the at least one channel (260) is defined by separation between the plurality of balloons (Figure 2B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of the combination of references such that the catheter comprises a plurality of balloons, forming at least one channel between the plurality of balloons, as taught by Flores, for the advantage of providing a plurality of balloons that can be selectively inflated individually (Paragraph 0098; Flores)
Regarding Claim 8, the combination of references disclosed above teaches the catheter of claim 7, wherein Flores teaches the plurality of balloons is at least three balloons (Figure 2B; Paragraph 0097).
Regarding Claim 9-10, the combination of references disclosed above teaches the catheter of claim 8, wherein Flores teaches a cross section of each of the at least three balloons comprises a circular shape (Figure 2B; Paragraph 0056 and 0097).
Regarding Claim 14, the combination of references disclosed above teaches the catheter of claim 1, wherein Adams teaches the elongated tube (21) comprises a guidewire lumen (29; Paragraph 0054) for receiving a guidewire, and wherein the catheter is configured to be advanced into the body lumen over the guidewire (Paragraph 0054; Adams).
Regarding Claim 15, Adams teaches a system for treating a stenosis in a body lumen (abstract), the catheter comprising:
an elongated tube (21; Figure 1; Paragraph 0050);
at least one shock wave generator (40) comprising at least one electrode pair (46/24; Figure 1; Paragraph 0051-0052);
at least one balloon (26; Figure 1) sealed to a distal end of the elongated tube (21) and surrounding the at least one shock wave generator (40) (Figure 1; Paragraph, the at least one balloon (21) fillable with a conductive fluid (saline; Paragraph 0050); and
a power source (30; Figure 1) configured to apply a voltage pulse to the at least one shockwave generator to generate shock waves for treating the stenosis (Paragraph 0053).
Adams fails to disclose:
at least one channel that permits blood to flow through the body lumen past the at least one balloon while the at least one balloon is inflated, wherein the at least one balloon comprises a plurality of lobes that extend outwardly from the elongated tube, and wherein the at least one channel is defined by spacing between the plurality of lobes of the at least one balloon, wherein a cross sectional area of the body lumen occupied by the plurality of lobes of the at least one balloon is less than a cross-sectional area of the body lumen corresponding to the spacing between the plurality of lobes of the at least one balloon.
Flores teaches a catheter for treating a stenosis in a body lumen (abstract) comprising:
an elongated tube (102; Figure 1; Paragraph 0045)
an energy source (124; Figure 1; Paragraph 0063)
at least one balloon (204A-C; Figures 2B; Paragraph 0096) (304A; Figure 3B; Paragraph 0104-0105)
at least one channel (260; Figure 2B) (360; Figure 3B) that permits blood to flow through the body lumen past the at least one balloon while the at least one balloon (304A) is inflated (Paragraph 0101 and 0109), wherein the at least one balloon (304A) comprises a plurality of lobes (304L1, 304L2, 304L3) that extend outwardly from the elongated tube (102; Figure 3B; Paragraph 0104-0105), and wherein the at least one channel (360; Figure 3B) is defined by spacing between the plurality of lobes (304L1-L3) of the at least one balloon (304A), wherein a cross sectional area of the body lumen (108; Figure 3B) occupied by the plurality of lobes (304L1-L3) of the at least one balloon (304A) is less than a cross-sectional area of the body lumen (108; Figure 3B) corresponding to the spacing between the plurality of lobes (304L1-L3) of the at least one balloon (304A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention modify the shockwave balloon catheter of Adams to include at least one channel that permits blood flow past the balloon while the balloon is inflated, as taught by Flores, for the advantage of enabling continued blood flow while treatment therapy is being applied (Paragraph 0109; Flores).
The combination of references fails to explicitly disclose:
wherein a cross sectional area of the body lumen occupied by the plurality of lobes of the at least one balloon is less than a cross-sectional area of the body lumen corresponding to the spacing between the plurality of lobes of the at least one balloon.
Liprie teaches a catheter for treating a stenosis in a body lumen (abstract) comprising
an elongated tube (12; Figures 5-10)
a balloon (41; Figures 5-10) sealed to the distal end of the elongated tube (12), wherein the balloon comprises a plurality of lobes (44, 46, 48; Figures 7-9 and Figures 9-10) that extend outwardly from the elongated tube (12) (see Column 5, Lines 55-58), and
at least one channel (space between lobes 44, 46, 48) that permits blood to flow through the body lumen past the at least one balloon (41) while the at least one balloon is inflated (Column 6, Lines 1-4), and wherein the at least one channel is defined by spacing between the plurality of lobes of the at least one balloon (Column 6, Lines 1-4),
wherein a cross sectional area of the body lumen occupied by the plurality of lobes (44-48) of the at least one balloon (41) is less than a cross-sectional area of the body lumen corresponding to the spacing between the plurality of lobes (44-48) of the at least one balloon (41) (Column 6, Lines 1-4 clearly state that when the centering balloon 41 is inflated, 30-50% of the passageway is blocked and thus it’s the Examiner’s position that 30-49% means that the balloon takes up less cross-sectional area than the spacing between the balloons, as presently claimed).
It would have been obvious to one of ordinary skill in the art to modify the combination of references disclosed above such that the plurality of lobes have a cross-sectional area less than the spacing between the lobes, taught by Liprie, for the advantage of allowing sufficient perfusion of bodily fluids during the time when the balloon is inflated (see Column 5, Lines 55-58; Liprie).
Regarding Claim 16, the combination of references disclosed above teaches the catheter of claim 15, wherein Liprie teaches the at least one channel permits blood to flow through the body lumen at a flow rate that is at least 50% of a normal flow rate of blood through the body lumen without the catheter positioned in the body lumen (Column 6, Lines 1-4).
Regarding Claim 21, the combination of references disclosed above teaches the catheter of claim 15, wherein Flores teaches the catheter comprises a plurality of balloons (204A-204C; Figure 2B) and a plurality of shock wave generators (222D; Paragraph 0099), each balloon of the plurality of balloons being sealed to a region of the elongated tube (Paragraph 0098-0099) and surrounding one or more of the plurality of shock wave generators (222D; Figure 2B), wherein the at least one channel (260) is defined by separation between the plurality of balloons (Figure 2B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of the combination of references such that the catheter comprises a plurality of balloons, forming at least one channel between the plurality of balloons, as taught by Flores, for the advantage of providing a plurality of balloons that can be selectively inflated individually (Paragraph 0098; Flores)
Regarding Claim 22, the combination of references disclosed above teaches the catheter of claim 21, wherein Flores teaches the plurality of balloons is at least three balloons (Figure 2B; Paragraph 0097).
Regarding Claim 23-24, the combination of references disclosed above teaches the catheter of claim 21, wherein Flores teaches a cross section of each of the at least three balloons comprises a circular shape (Figure 2B; Paragraph 0056 and 0097).
Regarding Claim 28, the combination of references disclosed above teaches the catheter of claim 15, wherein Adams teaches the elongated tube (21) comprises a guidewire lumen (29; Paragraph 0054) for receiving a guidewire, and wherein the catheter is configured to be advanced into the body lumen over the guidewire (Paragraph 0054; Adams).
Regarding Claim 29, Adams teaches a method for treating a stenosis in a body lumen, the method comprising:
advancing a catheter within the body lumen to a position proximate to the stenosis (Paragraph 0032);
inflating at least one balloon of the catheter so that an outer surface of the at least one balloon contacts the body lumen (Paragraph 0032); and
generating shock waves via at least one shock wave generator of the catheter (Paragraph 0032).
Adams fails to disclose:
blood is permitted to flow through the body lumen past the at least one balloon while the at least one balloon is inflated and generating shock waves while blood is flowing through the body lumen past the at least one balloon while inflated, at least one channel that permits blood to flow through the body lumen past the at least one balloon while the at least one balloon is inflated, wherein the at least one balloon comprises a plurality of lobes that extend outwardly from the elongated tube, and wherein the at least one channel is defined by spacing between the plurality of lobes of the at least one balloon, wherein a cross sectional area of the body lumen occupied by the plurality of lobes of the at least one balloon is less than a cross-sectional area of the body lumen corresponding to the spacing between the plurality of lobes of the at least one balloon.
Flores teaches a catheter for treating a stenosis in a body lumen (abstract) comprising:
an elongated tube (102; Figure 1; Paragraph 0045)
an energy source (124; Figure 1; Paragraph 0063)
at least one balloon (204A-C; Figures 2B; Paragraph 0096) (304A; Figure 3B; Paragraph 0104-0105)
at least one channel (260; Figure 2B) (360; Figure 3B) that permits blood to flow through the body lumen past the at least one balloon while the at least one balloon (304A) is inflated (Paragraph 0101 and 0109), wherein the at least one balloon (304A) comprises a plurality of lobes (304L1, 304L2, 304L3) that extend outwardly from the elongated tube (102; Figure 3B; Paragraph 0104-0105), and wherein the at least one channel (360; Figure 3B) is defined by spacing between the plurality of lobes (304L1-L3) of the at least one balloon (304A), wherein a cross sectional area of the body lumen (108; Figure 3B) occupied by the plurality of lobes (304L1-L3) of the at least one balloon (304A) is less than a cross-sectional area of the body lumen (108; Figure 3B) corresponding to the spacing between the plurality of lobes (304L1-L3) of the at least one balloon (304A).
and a method of:
advancing a catheter within the body lumen to a position proximate to the stenosis (Figure 3A; Paragraph 0102);
inflating at least one balloon of the catheter so that an outer surface of the at least one balloon contacts the body lumen (Figure 3B; Paragraph 0105) and blood is permitted to flow through the body lumen past the at least one balloon while the at least one balloon is inflated (Paragraph 0109); and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention modify the shockwave balloon catheter and method of use of Adams to include at least one channel that permits blood flow past the balloon while the balloon is inflated, as taught by Flores, for the advantage of enabling continued blood flow while treatment therapy is being applied (Paragraph 0109; Flores).
The combination of references fails to explicitly disclose:
wherein a cross sectional area of the body lumen occupied by the plurality of lobes of the at least one balloon is less than a cross-sectional area of the body lumen corresponding to the spacing between the plurality of lobes of the at least one balloon.
Liprie teaches a catheter for treating a stenosis in a body lumen (abstract) comprising
an elongated tube (12; Figures 5-10)
a balloon (41; Figures 5-10) sealed to the distal end of the elongated tube (12), wherein the balloon comprises a plurality of lobes (44, 46, 48; Figures 7-9 and Figures 9-10) that extend outwardly from the elongated tube (12) (see Column 5, Lines 55-58), and
at least one channel (space between lobes 44, 46, 48) that permits blood to flow through the body lumen past the at least one balloon (41) while the at least one balloon is inflated (Column 6, Lines 1-4), and wherein the at least one channel is defined by spacing between the plurality of lobes of the at least one balloon (Column 6, Lines 1-4),
wherein a cross sectional area of the body lumen occupied by the plurality of lobes (44-48) of the at least one balloon (41) is less than a cross-sectional area of the body lumen corresponding to the spacing between the plurality of lobes (44-48) of the at least one balloon (41) (Column 6, Lines 1-4 clearly state that when the centering balloon 41 is inflated, 30-50% of the passageway is blocked and thus it’s the Examiner’s position that 30-49% means that the balloon takes up less cross-sectional area than the spacing between the balloons, as presently claimed).
It would have been obvious to one of ordinary skill in the art to modify the combination of references disclosed above such that the plurality of lobes have a cross-sectional area less than the spacing between the lobes, taught by Liprie, for the advantage of allowing sufficient perfusion of bodily fluids during the time when the balloon is inflated (see Column 5, Lines 55-58; Liprie).
Regarding Claim 30, the combination of references disclosed above teaches the method of claim 29, wherein Adams teaches comprising advancing a guidewire within the body lumen to locate the stenosis and advancing the catheter over the guidewire (Paragraph 0050 and 0054; Adams).
Regarding Claim 33, the combination of references disclosed above teaches the catheter of claim 1, wherein Adams teaches the at least one shock wave generator (742 744; Figure 12) is mounted to the elongated tube (721) and oriented to propagate shock waves primarily along the direction of the lobes of the balloon (726) (Paragraph 0077; Adams)(furthermore see teachings in Flores which teaches the lobes, specifically Paragraph 0061 which discloses the catheter shaft 110 is coupled to the multiple energy guides 122a).
Claim(s) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams (US PGPub 2014/0005576), Flores (US PGPub 2022/0183738)and Liprie (US Patent 6,234,952), as applied to Claim 30 above, in further view of Patel (US PGPub 2020/0316350).
Regarding Claim 31, the combination of references disclosed above teaches the method of claim 30, but fails to disclose retracting the guidewire before inflating the balloon.
Patel teaches a method of an inflatable balloon that allows for perfusion while inflated (Abstract comprising retracting the guidewire before inflating the balloon (Paragraph 0072 states that if you need greater flow during inflation of the balloon, one can retract the guide wire back such that (for the advantage that) the guidewire does not block the proximal and distal openings of the bypass passageway).
It would have been obvious to one of ordinary skill in the art to modify the method of the combination of references disclosed above to include the teachings of Patel disclosed above, for the advantage that retracting the guidewire before inflating the balloon allows for perfusion through the lumen of the catheter.
Regarding Claim 32, the combination of references disclosed above teaches the method of claim 31, but wherein Patel teaches retracting the guidewire such that a distal end of the guidewire is located proximally of a proximal end of the balloon (Paragraph 0072 states that the wire is proximal the most proximal opening of the bypass passageway, and as seen in Figure 1, the proximal openings (17) are located proximally of the proximal end of the balloon (14; see Figure 1; Paragraph 0032 and 0072; Patel).
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 MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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