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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 22, 2026 has been entered.
Response to Arguments
Applicant's arguments filed July 22, 2026 have been fully considered but they are not persuasive in view of the rejections set forth below.
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.
Claims 1, 8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kontos et al (US 5180367) in view of Devens, Jr. Et al (US 7163523).
Regarding claims 1 and 13, Kontos et al (hereafter Kontos) discloses a support sleeve for use with a balloon catheter, the support sleeve comprising: a sleeve (56), consisting of a body (it is noted that the body can comprise multiple components), having a tubular in shape (52) having a proximal end (54), a distal end (50) and an internal diameter of a size and shape to receive a balloon catheter (C:7, L:13-29; C:6, L:20-30, Figure 4, it is noted that the balloon catheter is not positively recited so any arbitrary balloon catheter can fit within the lumen of sleeve 56); said sleeve configured to move in relation to and over said balloon catheter and said sleeve is configured to allow movement of said balloon catheter in relation to said sleeve (C:7, L:13-20); said sleeve configured to be inserted completely within a body of a patient (the entire sleeve 56 could be inserted completely within an arbitrary body location of a patient); a support balloon (34) directly attached to an exterior surface of the sleeve (figure 4); and an inflation tube (41, 35, 37, 39) in fluid communication with the support balloon, the inflation tube enables a fluid to be provided to the support balloon in order to inflate the support balloon (C:6, L:29-35), wherein said inflation tube comprises an inner diameter that is smaller than said inner diameter of said sleeve (figure 4); wherein said inflation tube extends proximally from a most proximal portion of said sleeve (figure 4), further comprising a coupling portion (figure 7) that provides for selectively coupling the support sleeve to a balloon catheter arranged within the internal diameter of the sleeve (71, C:6, L:58-69), wherein the coupling portion is a wire (71, 69) configured to contact the balloon catheter and an internal surface of the sleeve to restrict relative movement between the balloon catheter and the support sleeve (C:6, L:58-69; balloon catheter is inserted through the wire, and wire contacts internal surface of sliding guide means in figure 7).
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Kontos further discloses the sleeve (sliding guide mean) runs along the outside of the support balloon (C:6, L:45-50), and that the sleeve will only be slightly longer than the length of the balloon chamber (C:7. L:1-12). However, Kontos does not specifically disclose the actual axial lengths of the sleeve or the support balloon. However, Devens, Jr. et al (hereafter Devens) teaches it was known in the art at the time of the invention for vascular angioplasty balloon catheters (C:2, L:9) to have a length of about 8 to 40mm (C:4, L:35-37). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the support balloon of Kontos have an axial length between 5mm and 20mm, as taught as known in the art by Devens, as well as subsequently making the sleeve having a length (‘a length’ is sufficiently broad to encompass a length of 42) slightly longer than the length of the balloon chamber such that it is 30mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 8, Kontos in view of Devens teaches all of the limitations set forth in claim 1, wherein the support balloon is configured to be inflated to a diameter about equal to a diameter of a blood vessel adjacent to a narrowed blood vessel segment within a patient (C:7, L:20-29; C:8, L:1-8).
Claims 4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kontos et al (US 5180367) in view of Devens, Jr. Et al (US 7163523), as applied to claim 1 above, and further in view of Ainsworth et al (US 5451209).
Regarding claim 4, Kontos in view of Devens teaches all of the limitations set forth in claim 1, but does not disclose the wire is a flat-shaped wire having a width that is greater than a height. However, Ainsworth et al (hereafter Ainsworth) teaches it was known in the art at the time of the invention to make the internal surface of catheter sleeves formed of a plurality of reinforcing wire ribbons (31) to improve pushability (C:3, L:61-69). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the sleeve of Kontos further comprise a flat shaped wire having a width that is greater than a height (ribbon shaped) on the internal surface of the sleeve, in order to improve the pushability of the sleeve of the support sleeve disclosed by Kontos, wherein the wire would subsequently contact the balloon catheter (it is noted the balloon catheter is not positively claimed, so any arbitrary balloon catheter abutting the inner surface of the sleeve of Kontos would be in contact with the wire, and increased stiffness of the sleeve of Kontos would result in restricting the relative movement between the balloon catheter and the support sleeve when the arbitrary balloon catheter is tightly fit within the sleeve of Kontos).
Regarding claim 11, Kontos in view of Devens teaches all of the limitations set forth in claim 1, but does not disclose the support sleeve comprises a flexible tube having a braided filament coupled to an interior surface of the flexible tube. However, Ainsworth et al (hereafter Ainsworth) teaches it was known in the art at the time of the invention to make the internal surface of intravascular catheter sleeves formed of a braided filament coupled to an interior surface of the flexible tube (C:3, L:61-69; claim 1). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the support sleeve of Kontos comprise a flexible tube having a braided filament coupled to an interior surface of the flexible tube, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. In re Leshin, 125 USPQ 416.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kontos et al (US 5180367) in view of Devens, Jr. Et al (US 7163523), as applied to claim 3 above, and further in view of Plain et al (US 20050288766).
Regarding claim 5, Kontos in view of Devens teaches all of the limitations set forth in claim 3, but is silent to a coating layer on the wire. However, Plain et al (hereafter Plain) teaches it was known in the art at the time of the invention for control wires to be coated with a coating layer having a coefficient of friction sufficient to restrict relative movement between the wire and other components of the device (paragraph 0045). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to coat the wire (71, 69) of Kontos with a coating layer having a coefficient of friction sufficient to restrict the relative movement between the balloon catheter and the support sleeve in order to maintain the spacing and rotational position of the balloon catheter within the support sleeve for proper positioning of the device during a procedure.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kontos et al (US 5180367) in view of Devens, Jr. Et al (US 7163523), as applied to claim 2 above, and further in view of Hartley et al (US 20110230947).
Regarding claim 6, Kontos in view of Devens teaches all of the limitations set forth in claim 2, wherein the coupling portion is a wire (69), and the wire has a loop (69) for receiving the balloon catheter (C:6, L:58-69), and wherein the loop can tighten or loosen by pulling or extending the wire (71) in the proximal or distal direction in order to selectively restrict or allow relative movement between the balloon catheter and the support sleeve (C:8, L:39-51). Kontos does not disclose a winch to tighten or loosen the loop of the wire. However, Hartley et al (hereafter Hartley) teaches an intravascular device, wherein it was known in the art at the time of the invention to utilize a winch assembly (74) operable to pull a pull wire (paragraph 0053) while allowing for the wire to be locked at a particular position. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to further include a winch assembly, as taught as a known pulling mechanism at the time of the invention, coupled to the wire (69) of Kontos such that pulling wire in the proximal direction tightens or loosens the loop of Kontos to selectively restrict or allow relative movement between the balloon catheter and the support sleeve and in order for the wire to be locked at a particular position for added control.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kontos et al (US 5180367) in view of Devens, Jr. Et al (US 7163523), as applied to claim 1 above, and further in view of Pierpont et al (US 8608691).
Regarding claim 9, Kontos in view of Devens teaches all of the limitations set forth in claim 1, wherein the support balloon comprises: a first support balloon (34), wherein the first support balloon is positioned to inflate outward from the outer surface of the sleeve (figure 1). However, Kontos does not teach the support balloon comprises a second support balloon, wherein the second support balloon is positioned to inflate inward from an inner surface of the sleeve. However, Pierpont teaches it was known in the art at the time of the invention for a balloon dilation catheters to comprise internal balloons (30) that can be inflated to secure a balloon dilation catheter to an anchoring catheter (18; C:3, L:25-30; C:2, L:16-26). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to include an second support balloon on the inner surface of the sleeve of the device of Kontos, as taught as known in the art at the time of the invention by Pierpont, in order to secure the support sleeve to the balloon catheter.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kontos et al (US 5180367) in view of Devens, Jr. Et al (US 7163523), as applied to claim 1 above, and further in view of Sandridge (US 5299575).
Regarding claim 10, Kontos in view of Devens teaches all of the limitations set forth in claim 1, but does not disclose the inflation tube is a hypo-tube. However, Sandridge teaches it was known in the art at the time of the invention for guiding balloon catheters to utilize a hypo-tube to provide an inflation medium to a support balloon (C:2, L:53-64). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the inflation tube of Kontos a hypotube as known in the art by Sandridge, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. In re Leshin, 125 USPQ 416.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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/ANH T DANG/Primary Examiner, Art Unit 3771
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