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
Applicant’s election of Species A in the reply filed on 07/24/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 9, 10, and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species B-D, there being no allowable generic or linking claim.
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) 1-3, 5-8, 11-13, and 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ramanath et al. (US 2019/0099588).
Regarding claim 1, Ramanath et al. discloses a perfusion catheter (100, FIG 1-4) for drug delivery to tissue (abstract), the perfusion catheter comprising: an elongate catheter shaft (112) having a proximal end region (116, FIG 1, [0064]) and a distal end region (108) and including an inflation lumen (120) extending between the proximal end region and the distal end region ([0064], FIG 2); a balloon (102) positioned adjacent to the distal end region of the elongate catheter shaft (FIG 1-2) and in fluid communication with the inflation lumen ([0064]), the balloon being configured to move between a collapsed configuration and an expanded configuration (Expanded configuration shown in FIG 1-4. This state is described as the inflated state. [0064] also discloses “The fluid can be subsequently withdrawn from the connector 114 to deflate the balloon 102”, therefore disclosing a collapsed configuration) , where a first region of a surface of the balloon (Region defined by walls 130, FIG 2-4, [0066]) defines a perfusion channel (128, FIG 2-4, [0065-0069]); and a therapeutic coating (124) disposed on a second region of the surface of the balloon (122, [0065-0066]), wherein the second region is configured to contact the tissue in the expanded configuration ([0065]).
Regarding claim 2, Ramanath et al. discloses the first region is free of the therapeutic coating ([0065] discloses the drug coating covers substantially the entire exterior surface 126, but does not coat within the walls 130 of the interior lumen).
Regarding claim 3, Ramanath discloses the perfusion channel is configured to permit blood to flow substantially longitudinally about the balloon (Through the longitudinal channels as shown in FIG 2, [0065]) and wherein a flow rate of the blood is greater than about 20 milliliters per minute (The perfusion channel need only be configured to permit blood flow and therefore configured to permit a blood flow rate greater than 20 mL/min. The device of Ramanath is interpreted as being at least configured to allow for the claimed flow rate due to the overall disclosed size of the balloon, [0068-0070], and the presence of three perfusion channels).
Regarding claim 5, Ramanath et al. discloses the perfusion channel is formed of a plurality of perfusion channels (FIG 4 shows three perfusion channels 128).
Regarding claim 6, Ramanath et al. discloses each of the plurality of perfusion channels is substantially the same shape, substantially the same size, or both (FIG 4 shows substantially the same shape and size of each channel 128).
Regarding claim 7, Ramanath et al. discloses the second region is configured to be a first distance from a longitudinal axis of the perfusion catheter in the collapsed configuration (When the balloon is deflated, the outer surface/second region 122 is contracted and positioned closer to the longitudinal axis of the catheter), a second distance from the longitudinal axis of the perfusion catheter in the expanded configuration, and wherein the second distance is greater than the first distance (When the balloon is inflated, the outer surface of the balloon is positioned a second, greater distance from the longitudinal axis).
Regarding claim 8, Ramanath et al. discloses the perfusion channel is an individual perfusion channel (Under broadest reasonable interpretation, only one channel 128 can be taken to be the perfusion channel, thereby comprising an individual perfusion channel).
Regarding claim 11, Ramanath et al. discloses the second region is configured to be recessed a distance from the tissue when the balloon is in the collapsed configuration (It is understood that when the balloon is deflated such as during delivery, the outer surface of the balloon is at least configured to be not in contact with the tissue).
Regarding claim 12, Ramanath et al. discloses the perfusion channel further comprises a substantially longitudinally extending perfusion channel (FIG 2-3) that is configured to permit perfusion of blood from a first side of the balloon (From proximal opening 132) to a second side of the balloon (To distal opening 134) when the balloon is in the expanded configuration ([0065-0066]).
Regarding claim 13, Ramanath et al. discloses the perfusion channel comprises a gap between the first region of the surface of the balloon and the tissue (FIG 4 shows the spacing between 130 and the outer surface of the balloon which would be capable of being in contact with a tissue).
Regarding claim 15, Ramanath et al. discloses the therapeutic coating comprises a plurality of everolimus crystals or a plurality of paclitaxel crystals ([0006] discloses the drug coating can include Paclitaxel, which is commonly known to be in crystal form).
Regarding claim 16, Ramanath et al. discloses a perfusion catheter (100, FIG 1-4) for drug delivery to cardiac tissue (abstract, [0064]), the perfusion catheter comprising: an elongate catheter shaft (112) having a proximal end region (116, FIG 1, [0064]) and a distal end region (108) and including a guidewire lumen (106, [0064]) and an inflation lumen (120) extending between the proximal end region and the distal end region ([0064], FIG 2); a balloon (102) positioned adjacent to the distal end region of the elongate catheter shaft (FIG 1-2) and in fluid communication with the inflation lumen ([0064]), the balloon being configured to move between a collapsed configuration and an expanded configuration (Expanded configuration shown in FIG 1-4. This state is described as the inflated state. [0064] also discloses “The fluid can be subsequently withdrawn from the connector 114 to deflate the balloon 102”, therefore disclosing a collapsed configuration), where a first region of a surface of the balloon (Region defined by walls 130, FIG 2-4, [0066]) is uncoated ([0065] discloses the drug coating covers substantially the entire exterior surface 126, but does not coat within the walls 130 of the interior lumen) and defines a perfusion channel (128, FIG 2-4, [0065-0069]) configured to permit substantially longitudinal blood flow about the balloon (Through the longitudinal channels as shown in FIG 2, [0065]); and a therapeutic coating (124) disposed on a second region of the exterior surface of the balloon (122, [0065-0066]), wherein the second region is configured to contact the cardiac tissue in the expanded configuration ([0065]).
Regarding claim 17, Ramanath et al. discloses the first region is included in a plurality of first regions (Fig 4 shows at least three of the first regions 130), wherein the second region is included in a plurality of second regions (The second region can be taken at various radial intervals about the exterior surface, such as at locations corresponding to the first regions 130).
Regarding claim 18, Ramanath et al. discloses the plurality of first regions and the plurality of second regions are configured to alternate about an abluminal surface of the balloon (For example, as annotated below in FIG 3).
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Claim(s) 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu (CN 113384802A – see translation attached).
Regarding claim 19, Liu discloses perfusion catheter (FIG 1) for drug delivery to cardiac tissue ([0005]), the perfusion catheter comprising: an elongate catheter shaft (3, [0044, 0052]) having a proximal end region (Proximal end of shaft) and a distal end region (Distal end shown in FIG 1) and including an inflation lumen extending between the proximal end region and the distal end region ([0055] discloses a lumen within 3 to inflate and deflate the balloon body); a balloon (1) positioned adjacent to the distal end region of the elongate catheter shaft and in fluid communication with the inflation lumen (FIG 1, [0055]), the balloon being configured to move between an collapsed configuration ([0065] “As the drug-eluting device is introduced, guided by the guidewire in the delivery system, the undilated (folded) balloon body 1 is advanced to the stenotic lesion site 8”) and a radially expanded configuration (FIG 1 and 3-5) where a plurality of first regions of an exterior surface of the balloon are uncoated ([0047] discloses the outer surface of the device can be “partially” coated. Therefore the uncoated portions are interpreted as the first regions) and define a plurality of perfusion channels extending substantially longitudinally about the exterior surface of the balloon and being configured to permit blood to flow substantially longitudinally about the exterior surface (Grooves 7, FIG 5, [0015, 0016, 0065]), wherein a sum of the respective flow rates of the blood through each of the plurality of perfusion channels is greater than about 20 milliliters per minute (The perfusion channel need only be configured to permit blood flow and therefore configured to permit a blood flow rate greater than 20 mL/min. The device of Yuchen is interpreted as being at least configured to allow for the claimed flow rate due to the presence of four perfusion channels); and a therapeutic coating ([0041-0042]) disposed on a plurality of second regions of the exterior surface of the balloon 9Exterior surface portions which are coated, [0047]), wherein the plurality of second regions are configured to contact the cardiac tissue in the radially expanded configuration (As shown in FIG 5 where a plurality of radially outward regions are configured to contact the lumen wall of 8, which is a vascular stenosis lesion, [0065]).
Regarding claim 20, Liu discloses the plurality of first regions each have a substantially concave shape relative to a longitudinal axis of the perfusion catheter when the balloon is in the collapsed configuration (See annotated FIG 5 below. It is understood that the same concavity would exist in the collapsed configuration as well); and the plurality of second regions each have a substantially convex shape relative to the longitudinal axis of the perfusion catheter when the balloon is in the radially expanded configuration (See annotated FIG 5 below).
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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) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ramanath et al. (US 2019/0099588).
Regarding claim 4, Ramanath et al. discloses the invention substantially as claimed, as set forth above for claim 1.
Ramanath is silent regarding the dimensions of the perfusion channel, specifically having a width in a range from about 2 microns (0.0000787 inches) to about 50 microns (0.00197 inches) and a height in a range from about 2 microns (0.0000787 inches) to about 50 microns (0.00197 inches).
However, it would have been obvious to one of ordinary skill in the art to select a width and height from about 2-50 microns in order to allow for the preferred perfusion rate of the balloon and since this claimed dimension of the channel does not change the balloon’s ability to expand to deliver the drug coating while preventing occlusion of the vessel. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraph [0079] of applicants specification stating the dimensions should “ensure a sufficient amount of blood flow”), the Federal Circuit 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. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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