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
This office action is responsive to the amendment filed on 09/01/2026. As directed by the amendment: claims 1 and 11 have been amended, claims 2-10, 14, 16, and 17 have been cancelled and claim 18 has been added. Thus, claims 1, 11-13, 15, and 18 are presently pending in this application.
Election/Restrictions
Claim 18 is further withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/04/2026.
Newly added claim 18 is directed to a non-elected species. Species E (Figs. 28-39) Flow rate control device with one balloon and a flow port catheter with a distal tip extending beyond a distal end of the balloon was elected. Claim 18 is directed to species A which includes three coaxial balloons because claim 18 claims a third balloon disposed internal to the second balloon.
Response to Arguments
Applicant’s arguments, see pages 5-6, filed 09/01/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(2) as being anticipated by Sanchez Garcia (US 20180318560 A1), herein referenced to as “Sanchez Garcia” have been fully considered and are persuasive.
The applicant has amended claim 1 to further recite “an elongate, single chamber first balloon having a distal end, a proximal end, and a lumen extending therebetween… a radially inflated state… an elongate, single chamber second balloon disposed internal to the first balloon and…”.
The examiner agrees that the second balloon 18 of Sanchez Garcia is not an elongate balloon and that the first balloon has multiple chambers.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Cox et al (US 7087039 B1), herein referenced to as “Cox”.
Claim Rejections - 35 USC § 102
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cox et al (US 7087039 B1), herein referenced to as “Cox”.
Claim 1
Cox discloses: An endovascular occlusion device 10 + 44 (see Figs. 1 and 18-22, col. 5, lines 42-45) comprising: an elongate, single chamber first balloon 10 (see Figs. 1 and 18-22, col. 5, lines 42-45, single lumen 17, hence a single chamber) having a distal end 19 (see Fig. 1, col. 5, lines 64-67), a proximal end 18 (see Fig. 1, col. 5, lines 64-67), and a lumen 17 (see Fig. 1, col. 4, lines 1-5) extending therebetween, the first balloon 1 having a deflated state (see col. 5, lines 45-55, balloon can deflate and expand using the inflation lumen) and a radially inflated state (see Fig. 1, col. 5, liens 45-55, balloon shown in a radially inflated state), wherein the first balloon contacts an inner wall of a vasculature in the radially inflated state (see col. 1, lines 15-32, angioplasty balloon, hence the exterior balloon inflates to contact the inner walls of the vasculature to widen the vessel and to reestablish acceptable blood flow through the artery); and an elongate, single chamber second balloon 44 (see Figs. 18-22, col. 7-8, lines 55-6) disposed internal to the first balloon 10 (see Figs. 18-22, 44 is internal to 10) and having a distal end distal end of 44 (see Figs. 18-22), a proximal end proximal end of 44 (see Figs. 18-22), and a lumen the lumen of 44 (see Figs. 18-22) extending therebetween, the second balloon 44 having a deflated state (see Fig. 22, cols. 9-10, lines 65-23) and a radially inflated state (see Figs. 20-21, cols. 9-10, lines 65-23), wherein the second balloon 44 in the inflated state restricts blood flow (see Figs. 20-21, cols. 9-10, lines 65-23, when inflated it prevents blood flow) through the lumen 17 of the first balloon 10 and the second balloon 44 in the deflated state permits blood flow (see Fig. 22, cols. 9-10, lines 65-23, egress of fluid) through the lumen 17 of the first balloon 10.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox in view of Shoup et al (US 5591129 A), herein referenced to as “Shoup”.
Claim 11
Cox discloses: The endovascular occlusion device of claim 1, see 102 rejection above. Cox does not explicitly disclose: further comprising: a handle operable coupled to the first and second balloons.
However, Shoup in a similar field of invention teaches an endovascular device 10 (see Figs. 7-17 and 23-24) with a first balloon 16 (see Figs. 7-17 and 23-24) and a second balloon 70 (see Figs. 23-24) within the first balloon 16. Shoup further teaches: further comprising: a handle 54 (see Figs. 16-17, col. 2, lines 35-46, advancing the catheter, col. 7, lines 48-65) operable coupled to the first 16 and second balloons 70 (44 is attached to 70 to control the movement of 70 within the distal end of 16, while 12 is connected to the handle and allows for control of 16).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cox to incorporate the teachings of Shoup and teach an endovascular device with a handle operable coupled to the first and second balloons. Motivation for such can be found in Shoup as this allows for selective control of the perfusion and altering of the amount of perfusion of the catheter from outside the body (see col. 7, lines 47-67, col. 8, lines 1-6).
Claim 12
The combination of Cox and Shoup teaches: The endovascular occlusion device of claim 11, see 103 rejection above. Shoup further teaches: further comprising: a sheath 12 (see Figs. 7-17, col. 4, lines 46-57, col. 6, lines 45-54) having a proximal end proximal end of 12 attached to the handle (see Figs. 7-17, col. 2, lines 35-46, advancing the catheter, col. 7, lines 48-65), a distal end distal end of 12 attached to 16 (see Figs. 7-17), and a lumen the lumen of 12 (see Figs. 7-17) extending therebetween, the proximal end proximal end of 12 attached to the handle of the sheath 12 being operably coupled to the handle 54 and the distal end distal end of 12 attached to 16 of the sheath 12 being operably coupled (see Figs. 7-17 and 23-24, the sheath controls the relative positions of 16 and 70 by moving 16) to the first 16 and second balloons 70.
Claim 13
The combination of Cox and Shoup teaches: The endovascular occlusion device of claim 12, see 103 rejection above. Shoup further teaches: wherein the sheath 12 includes a plurality of lumens (see Figs. 7-8 and 23-24, 12 has several lumens, and has additional ones for 70 as 70 has an inflatable lumen that extends through 12).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox in view of Sanchez Garcia (US 20180318560 A1), herein referenced to as “Sanchez Garcia”.
Claim 15
Cox discloses: The endovascular occlusion device of claim 1, see 102 rejection above. Cox does not explicitly disclose: further comprising: a delivery sheath configured to surround and receive the first and second balloons.
However, Sanchez Garcia in a similar field of invention teaches an endovascular occlusion device 10 (see Figs. 1-5A, [0028]) comprising: a first balloon 12 (see Figs. 1-5A, [0028]) and a second balloon 18 (see Figs. 1-5A, [0031]) disposed internal to the first balloon 12 (see Figs. 1-5A, 18 within 12). Sanchez Garcia further teaches: a delivery sheath tubular, flexible sheath or cover (see [0028], over 12a) configured to surround and receive the first 12 and second balloons 18 (the sheath surrounds 12, which surrounds 18, hence the sheath surrounds both 12 and 18).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cox to incorporate the teachings of Sanchez Garcia and teach an endovascular device with a delivery sheath configured to surround and receive the first and second balloons. Motivation for such can be found in Sanchez Garcia as this protects the balloons when contact is made with a stenosed valve or the like (see [0028]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Franano et al (US 20160030050 A1) teaches an endovascular occlusion device with a balloon and an insertable guidewire that extends out of the distal end
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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
