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
The amendment filed December 15, 2025 has been entered. Claims 1-20 are currently pending.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thornton (US 5,573,508, hereinafter “Thornton”) in view of Krolik et al. (US 2010/0036410, hereinafter “Krolik”).
Regarding claim 1, Thornton discloses the invention substantially as claimed, including a system for treating a blood flow passage of a patient (Figs 1-3, 8-9), the system comprising:
a treatment element comprising: an expandable element (balloon 17) configured to be positioned within the passage, the expandable element having a collapsed configuration and an expanded configuration in which the expandable element defines a lumen therethrough (col 4, ln 58-67), and a reinforcing element (60) positioned within the lumen of the expandable element, the reinforcing element having a collapsed configuration and an expanded configuration in which the reinforcing element defines a lumen therethrough (col 7, ln 37-58);
a pushing element (62) comprising a proximal end portion and a distal end portion, wherein the distal end portion is configured to engage a proximal end portion of the reinforcing element such that distal movement of the pushing element causes the reinforcing element to radially expand (col 7, ln 37-58);
a first elongated member (15) defining a first lumen therethrough, the first lumen (16) in fluid communication with an interior region of the expandable element, wherein the first elongated member is configured to deliver a fluid to the interior region of the expandable element to expand the expandable element (col 4, ln 58-67);
a second elongated member (65) defining a second lumen therethrough, wherein a distal portion of the second elongated member is coupled to a distal portion of the reinforcing element (col 7, ln 37-58), wherein the second elongated member extends through the lumen of the expandable element (17) (col 2, ln 27-33 – “Means are provided to expand the perfusion lumen particularly the portion extending with the balloon on the distal end of the catheter shaft”; col 6, ln 19-24 – when describing the alternate embodiment of Figs 1-3: “The coil 25 should be long enough to expand at least a significant portion of the perfusion lumen 13 and is preferably long enough to extend from a location proximal to the proximal perfusion ports to a location near the distal end of the balloon e.g. about 10 to about 40 cm in length.”).
However, Thornton fails to disclose a third elongated member defining a third lumen therethrough, the third lumen configured to receive the first and second elongated members and the pushing element therein. Krolik discloses a similar system for treating a blood flow passage of a patient and teaches the treatment element comprising an expandable element and inner reinforcing element may further comprise one or more introducer sheaths or other tubular body to guide the device to the target area within the blood vessel (para [0081]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Thornton such that the system further included a third elongate member in the form of an introducer sheath, as taught by Krolik, wherein the introducer sheath defines a third lumen configured to receive the first and second elongated members and the pushing element therein to assist in guiding the device to the target area of the vasculature.
Regarding claim 2, wherein distal movement of the pushing element (62) causes distal movement of the proximal end portion of the reinforcing element (60) (Figs 8-9; relative movement between members 62 and 63 causes expansion/contraction of reinforcing element 60 – col 7, ln 37-58).
Regarding claim 3, wherein the distal end portion of the pushing element (62) is configured to substantially abut the proximal end portion of the reinforcing element (60) (Figs 8-9; col 7, ln 37-58).
Regarding claim 4, wherein, distal movement of the proximal end portion of the reinforcement element (60) causes the reinforcing element to axially compress and radially expand (Figs 8-9; relative movement between members 62 and 63 causes expansion/contraction of reinforcing element 60 – col 7, ln 37-58).
Regarding claim 5, wherein the pushing element (62) is configured to apply a distally directed force to the proximal end portion of the reinforcing element (60) (Figs 8-9; relative movement between members 62 and 63 causes expansion/contraction of reinforcing element 60 – col 7, ln 37-58).
Regarding claim 6, wherein the distal end portion of the pushing element (62) has a tubular shape (Figs 8-9; col 7, ln 37-58).
Regarding claim 7, Thornton teaches the “system is applicable for over-the-wire and rapid exchange type catheters” (col 2, ln 47-48). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Thornton and Krolik, such that the system was designed for rapid exchange and the pushing element exited the third lumen through an opening in a sidewall of the third elongated member. Thus, the system may be more easily exchanged with the guide wire in a rapid exchange manner as is old and well known in the art.
Regarding claim 8, wherein the reinforcing element (60) is configured to contact an inner wall of the expandable element (17).
Regarding claim 9, wherein the distal portion of the second elongated member (65) is coupled to the distal portion of the reinforcing element (60) via a coupler (adhesive or other securing means – col 6, ln 54-55).
Regarding claim 10, further comprising a stopper (integrally connected to proximal end portion of second elongate member 65) configured to limit axial translation of the pushing element (62) and/or axial compression of the reinforcing element (60) (Figs 8-9).
Regarding claim 11, further comprising a stopper (integrally connected to proximal end portion of second elongate member 65) configured to limit axial translation of the pushing element (62) and/or axial compression of the reinforcing element (60) (Figs 8-9), wherein the stopper is positioned proximal of the coupler (adhesive or other securing means).
Regarding claim 12, wherein a distal end portion of the stopper is secured to the coupler (stopper integrally connected to proximal end portion of second elongate member 65).
Regarding claim 13, wherein a proximal end portion of the stopper is secured to the pushing element (secured through reinforcing element 60).
Regarding claim 14, Thornton teaches the expandable element (balloon 17) may be secured by bonding or any suitable means (col 6, ln 50-59). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination such that the expandable element was secured to the second elongated member and/or the third elongated member by a tether as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp and since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success.
Allowable Subject Matter
Claims 15-20 are allowed.
The following is an examiner’s statement of reasons for allowance: Of the closest prior art, Thornton fails to teach or disclose the intermediate portion of the second elongate member is continuous and extends between the proximal and distal shoulders as amended.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed December 15, 2025, regarding the rejection of claims 1-14 under 35 U.S.C. 103 as being unpatentable over Thornton (US 5,573,508) in view of Krolik (US 2010/0036410), have been fully considered but they are not persuasive.
Applicant argues Thornton fails to disclose “wherein the second elongated member extends through the lumen of the expandable element”. Applicant argues Thornton fails to teach the alternative embodiment of the expanding means 23 shown in Figs 8 and 9 of Thornton, including the second elongated member (or distal collar 65), does not extend through the lumen of the balloon (17). The Examiner respectfully disagrees. Applicant points to Fig 1 of Thornton for evidence the expandable means does not extend through the balloon; however, a second position of Fig 3 clearly shows the expandable means extending through the balloon. Furthermore, Thornton teaches “Means are provided to expand the perfusion lumen particularly the portion extending with the balloon on the distal end of the catheter shaft” (col 2, ln 27-33).
Applicant’s arguments, see amendment, filed December 15, 2025, with respect to the rejection of claims 15-19 under 35 USC 102(a)(1) as being anticipated by Thornton (US 5,573,508) have been fully considered and are persuasive. Thornton fails to teach or disclose the intermediate portion of the second elongate member is continuous and extends between the proximal and distal shoulders as amended. The rejection has been withdrawn.
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 KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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