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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/4/2026 has been entered.
Response to Arguments
This Office action is in response to the applicant’s communication filed on 5/4/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s arguments, see pages 8-9, with respect to the Sardesai prior art reference failing to disclose the affirmative step of inflating a proximal portion of an expansion balloon that is recessed within a support catheter wherein a radial force is then applied against the support catheter while a distal portion of the balloon may conform to an inner surface of a blood vessel have been fully considered but are not persuasive. With regard the statement of intended use and other functional statements, they do not impose any structural limitations on the claims distinguishable over Sardesai which is capable of being used as claimed if one so desires to do so. In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Furthermore, the manner in which a device is intended to be employed does not differentiate the claimed apparatus from prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Applicant’s amendments and arguments appear to center on an intended use of the claimed system during a specific method step and fail to provide any specific distinguishable claimed structural limitations over the prior art of record. Sardesai expressly discloses a distal expandable balloon, that when inflated, provides radial forces against the interior of a support catheter (as expressly shown in annotated Figs. 6 and 9 below). Furthermore, in use, the distal portion of the balloon (907) is expressly depicted as being conformable to an inner surface of a blood vessel (931) (as expressly shown in annotated Fig. 9 below, where balloon 907 expressly conforms to the curvature of blood vessel 931). For at least these reasons, Applicant’s arguments are not persuasive.
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Applicant’s arguments, see page 9, with respect to the Daniels prior art reference failing to expressly disclose the affirmative step of inflating a proximal portion of an expansion balloon that is recessed within a support catheter wherein a radial force is then applied against the support catheter while a distal portion of the balloon may conform to an inner surface of a blood vessel have been fully considered and are persuasive. Therefore, the previous 102 prior art rejections made under Daniels alone have been withdrawn. However, upon further consideration, new 103 ground(s) of rejection are made under Daniels in view of Sardesai, as set forth below.
Claim Rejections - 35 USC § 102
Claim(s) 1-2 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sardesai et al. (US 10,792,469).
Sardesai discloses (see Figs. 6 and 9) a system for delivering medical devices to locations within a patient’s body comprising the following claim limitations:
(claim 1) A catheter system comprising a first catheter (624) having a first lumen surrounded by a first catheter shaft (i.e., shaft of outer catheter 624 shown having an inner lumen in Fig. 6); a second catheter (611/612) that is inserted into the first lumen of the first catheter (624) (as shown in Fig. 6), wherein, wherein the first catheter (624) comprises a support catheter (as expressly shown in Fig. 6; col. 1, lines 17-20; col. 3, lines 32-44; col. 4, line 48-col. 5, line 7; outer catheter is expressly disclosed as being a guiding catheter) and the second catheter (611/612) comprises a percutaneous transluminal angioplasty (PTA) catheter (as shown in Fig. 6 and exemplary Figs. 11-13; inner balloon catheter 611/612 expressly disclosed as fully capable of being used to treat stenosis if one so desires); and the support catheter (624) and the PTA catheter (611/612) are arranged such that a proximal portion of a vessel expansion balloon (607) of the PTA catheter is recessed within the support catheter (624) during inflation, wherein the proximal portion of the vessel expansion balloon (607) of the PTA catheter comprises a recessed portion shaped to apply radial forces against the support catheter (624) when expanded by inflation to be constrained in a distal end section of the support catheter (624) while another portion of the vessel expansion balloon (607) of the PTA catheter is expanded by inflation to conform to an inner surface of a vessel wall (as expressly shown in annotated Figs. 6 and 9 above in the Response to Arguments section, wherein in use, the distal portion of the balloon 907 is expressly depicted as expressly conforming to the curvature of the blood vessel 931; col. 9, line 57-col. 10, line 39; distal balloon expressly may be disposed 50% inside the support catheter and 50% outside the support catheter, or varying positions as one so desires during use);
(claim 2) wherein the PTA catheter (611/612) comprises a balloon-length-adjustable PTA catheter (as shown in Fig. 6; col. 8, lines 9-15; orienting balloon expressly disclosed to be fully capable of inflation fully outside of the guide catheter and/or adjusting the position of orienting balloon at least partially recessed within the guide catheter when the orienting balloon is inflated) (as also shown in annotated Fig. 9 above, col. 9, line 57-col. 10, line 39; distal balloon expressly may be disposed 50% inside the support catheter and 50% outside the support catheter, or varying positions as one so desires during use); and
(claim 4) wherein the PTA catheter (611/612) comprises a second lumen (621/622) surrounded by a second catheter shaft (as shown in Fig. 6) and one or more hydraulically inflatable stabilizers (601/602) being in fluid communication with the second lumen (621/622) (as shown in Fig. 6; col. 7, lines 41-58), and wherein the one or more stabilizers (601/602) is/are adapted when being hydraulically inflated via the second lumen (621/622) to form an inflation-fluid chamber being inflatable radially outward to compress the stabilizer (601/602) against an inner surface of the first catheter shaft (624) and fix the position of the PTA catheter (611/612) within the support catheter (624) and constrain the PTA catheter (611/612) to a coaxial disposition with respect to the support catheter (624) (as shown in Fig. 6; col. 7, lines 41-58; axial anchoring of balloon catheter position expressly disclosed), and wherein the one or more stabilizers (601/602) each comprise edge portions (i.e., proximal and distal end portions) and a central portion (i.e., central widest diameter portion shown directly contacting first catheter 624 in Fig. 6), wherein the edge portions are affixed to an inner or outer surface of the second catheter shaft (611/612), and wherein the central portion is not affixed to the inner or outer surface of the second catheter shaft (611/612) (as expressly shown in Fig. 6).
Claim Rejections - 35 USC § 103
Claim(s) 1-2, 4, 8-14 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Daniels et al. (US 2016/0051799) further in view of Sardesai et al. (US 10,792,469).
Daniels discloses (see Fig. 6-8) a stabilizing and sealing catheter system comprising the following claim limitations:
(claim 1) A catheter system comprising a first catheter (200) having a first lumen surrounded by a first catheter shaft (i.e., shaft of outer catheter 200 shown having an inner lumen in Fig. 8); a second catheter (50, Figs. 6-7) that is inserted into the first lumen of the first catheter (200) (as shown in Fig. 8), wherein, the first catheter (200) comprises a support catheter (as shown in Fig. 8; [0052]; outer catheter is expressly disclosed as being a support/guide catheter) and the second catheter (50) comprises a percutaneous transluminal angioplasty (PTA) catheter (as shown in Fig. 6-8; inner balloon catheter 50 expressly disclosed as fully capable of being used to treat stenosis/lesions if one so desires), and the support catheter (200) and the PTA catheter (50) are arranged such that a proximal portion of a vessel expansion balloon (26) of the PTA catheter is recessed within the support catheter (200) during inflation (as shown in Fig. 6-8; vessel expansion balloon 26 is fully capable of being inflated when the distal half of the balloon 26 extends outside of the distal end of the support catheter 200 with the proximal half of balloon 26 remaining within the lumen of support catheter 200);
(claims 2, 10 and 29) wherein the PTA catheter (50) comprises a balloon-length-adjustable PTA catheter (as shown in Figs. 6-8; vessel expansion balloon 26 is fully capable of inflation when (1) fully outside of the support catheter 200, (2) partially recessed within the support catheter 200; and/or (3) fully disposed within support catheter 200);
(claim 4) wherein the PTA catheter (50) comprises a second lumen (at 46) surrounded by a second catheter shaft (as shown in Figs. 6-5) and one or more hydraulically inflatable stabilizers (66) being in fluid communication with the second lumen (46) (as shown in Fig. 6-8; [0055]; proximal inlet 63 expressly provides fluid communication), and wherein the one or more stabilizers (66) is/are adapted when being hydraulically inflated via the second lumen (46) to form an inflation-fluid chamber being inflatable radially outward to compress the stabilizer (66) against an inner surface of the first catheter shaft (200) and fix the position of the PTA catheter (50) within the support catheter (200) and constrain the PTA catheter (50) to a coaxial disposition with respect to the support catheter (200) (as shown in Fig. 8; [0052]-[0055]; axial anchoring of balloon catheter 50 position expressly disclosed), and wherein the one or more stabilizers (66) each comprise edge portions (i.e., proximal and distal end portions of balloon 66) and a central portion (i.e., central widest diameter portion shown directly contacting first catheter 200 in Fig. 8), wherein the edge portions are affixed to an inner or outer surface of the second catheter shaft (50), and wherein the central portion is not affixed to the inner or outer surface of the second catheter shaft (50) (as expressly shown in Fig. 8);
(claim 8) A percutaneous transluminal angioplasty (PTA) apparatus comprising a support catheter (200); and a percutaneous transluminal angioplasty (PTA) catheter (50) within the support catheter (200) (as shown in Fig. 6-8; inner balloon catheter 50 expressly disclosed as fully capable of being used to treat stenosis/lesions if one so desires), the percutaneous transluminal angioplasty catheter (50) comprising a distal end (68) and a catheter balloon (26) mounted to the distal end (68) (as shown in Figs. 6-8), an inflation lumen (46/67), and one or more hydraulically inflatable stabilizers (66), wherein the inflation lumen (46/67) is in fluid communication with an internal volume of the catheter balloon (26) and the one or more hydraulically inflatable stabilizers (66) (as expressly shown in Fig. 7; [0055]) and the support catheter (200) and the PTA catheter (50) are arranged such that a proximal portion of a vessel expansion balloon (26) of the PTA catheter is recessed within the support catheter (200) during inflation (as shown in Fig. 6-8; vessel expansion balloon 26 is fully capable of being inflated when the distal half of the balloon 26 extends outside of the distal end of the support catheter 200 with the proximal half of balloon 26 remaining within the lumen of support catheter 200);
(claim 9) A percutaneous transluminal angioplasty apparatus comprising a guide wire ([0006]; [0008]-[0009]; [0012]; [0056]; [0061]; [0065]; use of a guidewire expressly disclosed to facilliate exchange of therapeutic devices); a support catheter (200); and a percutaneous transluminal angioplasty (PTA) catheter (50) within the support catheter (200) (as shown in Fig. 6-8; inner balloon catheter 50 expressly disclosed as fully capable of being used to treat stenosis/lesions if one so desires); the percutaneous transluminal angioplasty catheter (50) comprising a distal end (68), a proximal end (at 13, Fig. 6), an outer shaft (46/62), a catheter balloon (26) mounted to the distal end (68) (as expressly shown in Figs. 6-8), an inflation lumen (46/67) in fluid communication with the internal volume of the catheter balloon (26), and a guidewire lumen (at 64/65, Fig. 7) through which the guidewire passes ([0012]; [0052]; [0055]), wherein the support catheter (200) and the PTA catheter (50) are arranged such that a proximal portion of a vessel expansion balloon (26) of the PTA catheter is recessed within the support catheter (200) during inflation (as shown in Fig. 6-8; vessel expansion balloon 26 is fully capable of being inflated when the distal half of the balloon 26 extends outside of the distal end of the support catheter 200 with the proximal half of balloon 26 remaining within the lumen of support catheter 200);
(claim 11) one or more stabilizers (66), that, when activated via the inflation lumen (46), fix the position of the PTA catheter (50) within the support catheter (200) and constrain the PTA catheter (50) to a coaxial disposition with respect to the support catheter (200) (as shown in Fig. 8; [0052]-[0055]; axial anchoring of balloon catheter 50 position expressly disclosed);
(claim 12) wherein the one or more stabilizers (66) each comprises a band of stabilizer elastomeric material ([0053]) mounted to the surface of a PTA catheter shaft of the PTA catheter (50) (as shown in Figs. 6-8); and one or more inflation-fluid ports (63) below a central portion of the band of stabilizer elastomeric material (at 66) (as shown in Fig. 7);
(claim 13) wherein the central portion (i.e., central widest diameter portion of 66 shown directly contacting first catheter 200 in Fig. 8) of the band (66) of stabilizer elastomeric material ([0053]) is not affixed to the outer surface of the PTA-catheter shaft (at 62) (as shown in Figs. 6-8); wherein two edge portions of the band (66) of stabilizer elastomeric material are affixed to the outer surface of the PTA-catheter shaft (at 62) (as shown in Fig. 7), forming an expandable, annular inflation-fluid chamber (i.e., interior space of anchor balloon 66) between the central portion of the band (66) of stabilizer elastomeric material and an underlying outer surface of the PTA-catheter shaft (at 62) and one or more inflation-fluid ports (63) (as expressly shown in Fig. 7); and
(claim 14) wherein the inflation-fluid chamber (i.e., interior space of anchor balloon 66) is adapted to be inflated radially outward, compressing the stabilizer (66) against the inner surface of the support-catheter shaft (200) when pressurized inflation fluid is introduced into the inflation lumen (46/67) of the PTA catheter (50) and the pressurized inflation fluid flows through the inflation-fluid ports (63) into the annular inflation-fluid chamber (as expressly shown in Figs. 7-8; [0052]; [0055]).
Daniels, as applied above, discloses a stabilizing and sealing catheter system comprising all the limitations of the claim except for wherein the proximal portion of the vessel expansion balloon of the PTA catheter comprises a recessed portion shaped to apply radial forces against the support catheter when expanded by inflation to be constrained in a distal end section of the support catheter while another portion of the vessel expansion balloon of the PTA catheter is expanded by inflation to conform to an inner surface of a vessel wall.
However, Sardesai teaches (see annotated Figs. 6 and 9 in the Response to Arguments section above) a similar system for delivering medical devices to locations within a patient’s body wherein the proximal portion of the vessel expansion balloon (907) of the PTA catheter (901) comprises a recessed portion shaped to apply radial forces against the support catheter (924) when expanded by inflation to be constrained in a distal end section of the support catheter (924) while another portion of the vessel expansion balloon (907) of the PTA catheter (901) is expanded by inflation to conform to an inner surface of a vessel wall (931) (col. 9, line 57-col. 10, line 39) in order to beneficially assist in facilitating the placement, orientation, and positioning of a catheter at desired locations within a patient’s vasculature (see Abstract; col. 1, lines 15-36; col. 3, lines 14-47; col. 9, line 57-col. 10, line 2). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Daniels to have the proximal portion of the vessel expansion balloon of the PTA catheter comprise a recessed portion shaped to apply radial forces against the support catheter when expanded by inflation to be constrained in a distal end section of the support catheter while another portion of the vessel expansion balloon of the PTA catheter is expanded by inflation to conform to an inner surface of a vessel wall in order to beneficially assist in facilitating the placement, orientation, and positioning of a catheter at desired locations within a patient’s vasculature, as taught by Sardesai.
Allowable Subject Matter
Claims 18-24 are allowed.
The following is an examiner’s statement of reasons for allowance: the art of record does not teach or render obvious a catheter system as claimed that includes, in combination with the claim(s) as a whole, wherein the band of stabilizer elastomeric material has an elasticity, deformability and/or compliance different from that of the PTA-catheter balloon so that the stabilizer is fully inflated at a different point in time than the point of time when the PTA-catheter balloon is fully inflated.
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.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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