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 .
Election/Restrictions
Claims 13-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 20, 2026.
Applicant’s election without traverse of Invention I, claims 1-12 in the reply filed on July 20, 2026 is acknowledged.
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 2-4 and 12 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.
With regards to claim 2, the claim refers to “a reentry guidewire” in line 2. It is unclear as to whether the “reentry guidewire” is referring to the same “guidewire” set forth in line 1 of claim 1 or referring to a different guidewire. For examination purposes, Examiner assumes the former.
Claim 4 recites the limitation "the reentry guidewire" in line 1. There is insufficient antecedent basis for this limitation in the claim. Note that claim 1 refers to a “guidewire” in line 1.
With regards to claim 12, in line 2, the claim recites “securing an elongate body of the IVUS catheter to the elongate body”. It is unclear as to how the elongate body of the catheter can be secured to itself.
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) 1-5 and 9-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crowley et al. (US Patent No. 5,372,138).
With regards to claim 1, Crowley et al. disclose a system for facilitating reentry of a guidewire into a true lumen, the system comprising:
an elongate shaft (202) having a proximal end and a distal end and a reentry guidewire lumen extending therethrough, the reentry guidewire lumen having an exit port at a distal end region of the elongate shaft (column 17, lines 24-34, referring to the balloon catheter (200) comprising a catheter shaft (202); column 17, lines 42-49, referring to the guide wire (214) extending past the distal end of the catheter; Figures 20, 21, wherein, as depicted in Figures 20-21, the guide wire passes through a distal aperture at the distal end of the shaft (202));
an intravascular ultrasound (IVUS) catheter engagement region (region comprising the balloon(s) (204, 206)), configured as a capsule, coupled to the distal end of the elongate shaft (column 17, lines 24-34, referring to the balloons (204, 206), wherein proximal and distal ends of the balloon (204) are tacked/coupled onto catheter shaft (202) at locations adjacent the proximal and distal ends of balloon (204); Figures 20-21, wherein the acoustic transducer (224) is depicted in the Figures to be within the region including the balloons (204, 206) ; and
an IVUS imaging window disposed in a sidewall of the capsule, wherein the capsule is configured to receive an IVUS catheter to orient the IVUS catheter to image through the IVUS imaging window (column 11, lines 7-13, 23-27, referring to the balloon material being sonolucent and therefore the balloon material of the balloons (204, 206) forms an IVUS imaging window, wherein the catheter is formed having sonolucent regions corresponding to the location of the transducer while the rest of the catheter is not sonolucent; Figures 20-21, wherein the acoustic transducer (224) is depicted in the Figures to be within the region including the balloons (204, 206) forming the capsule).
With regards to claim 2, Crowley et al. disclose that the system further comprises a guide (i.e. in the form of a channel) in or adjacent to the exit port to deflect a reentry guidewire laterally relative to a long axis of the elongate shaft (column 17, lines 42-49, referring to “The guide wire may also be passes through a saddle as discussed above, for example with respect to FIG. 7a”, wherein, as set forth in column 11, lines 63-67, in Figure 17a, the guide wire passes through a side aperture (153) in the extension (157) of the catheter (139) distal to the balloon, through the inner lumen of the extension (157) and a distal aperture (161); Figures 17a, 20-21, wherein, as depicted in Fig. 17a, a guidewire entering through the aperture (153) and exiting through aperture (161) would result in a deflection of the guidewire laterally relative to a long axis of the elongate shaft).
With regards to claim 3, Crowley et al. disclose that the guide comprises a ramp, a channel or a deflector (column 17, lines 42-49, referring to “The guide wire may also be passes through a saddle as discussed above, for example with respect to FIG. 7a”, wherein, as set forth in column 11, lines 63-67, in Figure 17a, the guide wire passes through a side aperture (153) in the extension (157) of the catheter (139) distal to the balloon, through the inner lumen of the extension (157) and a distal aperture (161), and thus the guide wire is guided by a guide in the form of a channel of the saddle (159) and extension (157).
With regards to claim 4, Crowley et al. disclose that the system further comprises the reentry guidewire (214) (column 17, lines 42-49, referring to the guidewire (214); Figures 20-21).
With regards to claim 5, Crowley et al. disclose that the IVUS imaging window (i.e. sonolucent region of balloons (204, 206)) is positioned laterally adjacent to the exit port (161) (see Figure 21, wherein the balloons (204, 206) [and thus the IVUS imaging window] is depicted as being positioned laterally adjacent to the exit port through which the guide wire (214) passes through).
With regards to claim 9, Crowley et al. disclose that the system comprises one or more ultrasound markers on the distal end region of the elongate shaft and/or on the capsule (column 20, lines 12-22, referring to markers made of metallic material being at the tip of the device, wherein metal has the inherent property of being echogenic and therefore the metallic markers are considered to be “ultrasound markers” as they would be visible in ultrasound images).
With regards to claim 10, Crowley et al. disclose that the system comprises one or more engagement features (i.e. coil-form drive shaft (222)) within the capsule configured to orient the IVUS catheter (column 18, lines 2-8, referring to the coil-form drive shaft (222) having at its distal portion an acoustic transducer (224), wherein the shaft is rotatable, enabling acoustic imaging of the lumen to be treated for positioning of the catheter and balloons, and therefore the drive shaft (222) serves as an engagement feature within the capsule formed by the balloons (204, 206) configured to orient the IVUS catheter via its ability to rotate, etc.; Figures 20-21).
With regards to claim 11, Crowley et al. disclose that the system further comprises the IVUS catheter (i.e. formed by the acoustic transducer (224) and drive shaft (222) (column 18, lines 2-4, referring to within the catheter is positioned a coil-form drive shaft (222) having at its distal portion an acoustic transducer (224); Figures 20-21).
With regards to claim 12, Crowley et al. disclose that the system further comprises one or more attachments releasably securing an elongate body of the IVUS catheter to the elongate body (column 18, lines 61-66, referring to the imaging catheter being withdrawn from the device, and therefore inherently there are attachments are releasably secure the elongate body of the IVUS catheter; column 16, line 23-column 17, line 5, referring to the features such as the slide assembly (240), etc. which are provided to receive the catheter sheath (139) and drive shaft (145) to allow the drive shaft and transducer (146) to slid axially in different positions, and thus form an attachment with the imaging catheter which is released when the imaging catheter is withdrawn; Figures 20-21).
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) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crowley et al. as applied to claim 1 above, and further in view of Diederich et al. (US Patent No. 6,117,101).
With regards to claims 6 and 7, as discussed above, Crowley et al. meet the limitations of claim 1. However, though Crowley et al. do disclose that the capsule/balloon can be used in treatment procedures, such as heated balloon angioplasty procedures (column 10, lines 33-37), Crowley et al. do not specifically disclose that the IVUS imaging window comprises a cut-out region [claim 6] or that the capsule/balloon comprises a porous material [claim 7].
Diederich et al. disclose a circumferential ablation device to less invasively ablate a circumferential region of tissue, wherein an expandable member, such as an inflatable balloon, can include a porous skin that is adapted to allow fluid, such as hypertonic saline solution, to pass from an internal chamber defined by the skin and outwardly into surrounding tissues (Abstract; column 24, lines 17-27). Further, a cut-out region (i.e. 603, “equatorial band (603) of uninsulated balloon skin) can be provided in the balloon region which allows for more efficient conduction of heat externally of the balloon skin (column 25, lines 3-33; Figure 12, note that the IVUS imaging window of Crowley et al. corresponds to the balloon itself and therefore the cut-out region (603) of Diederich et al. corresponds to a cut-out region of the IVUS imaging window of Crowley et al.)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the IVUS imaging window of Crowley et al. comprise a cut-out region [claim 6] and have the capsule/balloon of Crowley et al. comprises a porous material [claim 7], as taught by Diederich et al., in order to allow for more efficient conduction of heat externally of the balloon skin (column 25, lines 3-33) and in order to provide a means to less invasively successfully ablate a circumferential region of tissue (Abstract).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crowley et al. as applied to claim 1 above, and further in view of Zhou et al. (US Pub No. 2014/0018837).
With regards to claim 8, as discussed above, Crowley et al. meet the limitations of claim 1. However, Crowley et al. do not specifically disclose that the capsule comprises a distal opening for an IVUS guidewire.
Zhou et al. disclose a subintimal recanalization catheter system for recanalizing a blood vessel, wherein a penetration member (224) may be configured to project distally from the distal end (206) of the balloon catheter and a guidewire (118) may be used as the penetration member (Abstract; paragraphs [0046], [0048]; Figures 2, 7-9, wherein the figures depicts a balloon (214) comprising a distal opening for an IVUS guidewire (118)). The balloon secured to a distal portion of the catheter shaft may be configured to be inflated to cause a distal portion of the catheter shaft to deflect toward the lumen of the blood vessel within the subintimal space to facilitate reentry into the lumen of the blood vessel (paragraphs [0005], [0024], [0042]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the capsule/balloon of Crowley et al. comprise a distal opening for an IVUS guidewire, as taught by Zhou et al., in order to successfully facilitate reentry into the lumen of a blood vessel (paragraphs [0005], [0024], [0042]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jang et al. (US Patent No. 5,100,424) disclose a catheter comprising at least one inflatable balloon provided external the housing so as to provide the side of the housing having the aperture against the target stenotic material, wherein the inflatable balloon (224) is provided opposite aperture (220) and external to housing (218) (column 6, lines 3-17; Figure 2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
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