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 .
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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 26, 2026 has been entered. Claims 1-19 are pending in the application. The previous objections to the claims and rejections of claims under 35 U.S.C. 112(a) are withdrawn in light of Applicant’s amendments to the claims. Response to applicant's arguments can be found at the end of this office action.
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.
Claims 1, 6-13, 15-16, and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Connors et al. (U.S. Patent No. 10327880; hereinafter “Connors”).
Regarding claim 1, Connors discloses an applicator (370; Figs. 34A-34B; col. 15, ll. 32-65) for delivering a fillable balloon into a body cavity comprising:
(a) a tubular shaft (374; Fig. 34A) having a lumen;
(b) a tubular capsule (372) releasably attached or adapted to be releasably attached to a distal tip of the shaft (inner sheath (372) is attached to the distal end/tip of outer sheath (374) so as to be released from the distal end/tip of the outer sheath by proximal movement of the outer sheath; Figs. 34A-34B); the capsule having a lumen adapted to receive a balloon in an uninflated or unfilled or partially filled state (Fig. 34A); and,
(c) a pusher (382) located in the lumen of the tubular shaft having a distal end adapted to be inserted into a valve of the balloon (Fig. 34A), the pusher being adapted to:
push the balloon out from the capsule lumen (col. 15, ll. 62-64);
conduct a fluid from a proximal end of the applicator to the balloon to inflate or fill the balloon with the fluid through the valve (col. 15, ll. 64-65); and,
detach the balloon from the distal end of the pusher (col. 15, ll. 64-65).
Regarding claim 6, Connors discloses the applicator being adapted to deliver a fillable balloon to a body cavity selected from urinary bladder, a rectum, a stomach or a vagina (col. 15, ll. 29-31).
Regarding claim 7, Connors discloses wherein the capsule is straight (Fig. 34A shows inner sheath (372) in a straight configuration).
Regarding claim 8, Connors discloses wherein the capsule is curved (at curved ramp (384); Figs. 34A-34B; col. 15, ll. 57-58).
Regarding claim 9, Connors discloses wherein the applicator is adapted to treat a fistula (delivery system (370) is capable of treating a fistula in a bladder because the system is structured for insertion into a patient’s bladder to deliver a treatment balloon and no structure of the system would prevent its use to treat a fistula in the bladder).
Regarding claim 10, Connors discloses a balloon for use in the applicator according to claim 1, having a magnet (236; Fig. 21; col. 25, ll. 45-62).
Regarding claim 11, Connors discloses a capsule (372; Figs. 34A-34B) for use in the applicator according to claim 1, having a fillable balloon (380) provided in an unfilled or partially filled state being folded, rolled, or crumpled in an interior of the capsule (Figs. 34A-34B; col. 15, ln. 67 – col. 16, ln. 13).
Regarding claim 12, Connors discloses wherein the capsule is straight (Fig. 34A shows inner sheath (372) in a straight configuration).
Regarding claim 13, Connors discloses wherein the capsule is curved or bent (at curved ramp (384); Figs. 34A-34B; col. 15, ll. 57-58).
Regarding claim 15, Connors discloses a system for delivering a fillable balloon into a body cavity comprising:
(a) an applicator (370; Figs. 34A-34B; col. 15, ll. 32-65) according to claim 1 (see rejection above addressing the limitations of the applicator of claim 1); and
(b) one or more balloons (380) configured to be folded or rolled in the lumen of the capsule of the applicator (Fig. 34A; col. 15, ll. 41-43).
Regarding claim 16, Connors discloses the system further comprising a retrieval device (150) configured to deflate a filled balloon in the body cavity and to remove the balloon from the body cavity (Fig. 12; col. 20, ln. 17 – col. 21, ln. 23).
Regarding claim 18, Connors discloses wherein a portion of the tubular capsule connects with and is housed inside of the lumen of the tubular shaft (Fig. 34A).
Regarding claim 19, Connors discloses wherein the tubular shaft (374) and the tubular capsule (372) are configured in a side-by-side configuration (34A-34B; the interior side of sheath (374) is positioned next to the exterior side of sheath (372); thus, they are in a “side-by-side” configuration).
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.
Claims 2-5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Conners.
Regarding claim 2, Connors discloses the invention substantially as claimed, except for the shaft having a slit in a wall of the shaft.
However, Connors further teaches providing a shaft with slits (388) in a wall of a shaft (386), exposing the lumen of the shaft to the exterior (Figs. 35A-35B; col. 51, ln. 66 – col. 16, ln. 13) to allow the shaft to open and facilitate deployment of a fillable balloon to treat a patient (col. 16, ll. 3-13).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular shaft to include a slit in a wall of the shaft, exposing the lumen of the shaft to the exterior, in view of Connors, in order to facilitate pushing the balloon out of the shaft for deployment within a patient.
Regarding claim 3, Connors discloses the invention substantially as claimed, except for the pusher including a hollow tube with a needle at its distal end
However, Connors further teaches a pusher including a hollow tube with a needle (50) at its distal end (Figs. 6-7B) to allow pre-mounting a balloon to the pusher to facilitate delivery and inflation of the balloon within a patient (col. 13, ln. 67 – col. 14, ln. 49).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the pusher to include a hollow tube with a needle at its distal end, in view of Connors, in order to facilitate positioning and inflating a balloon within a patient.
Regarding claim 4, Connors discloses wherein the capsule is adapted to be attached to the shaft and to lock onto the distal tip of the shaft (Fig. 34A).
Regarding claim 5, Connors discloses wherein the pusher is connected to a male Luer connector (56) at the proximal end of the pusher (Fig. 6; col. 14, ll. 6-8).
Regarding claim 14, Connors discloses the invention substantially as claimed, except for the balloon having a magnet.
However, Connors further teaches providing a balloon with (236) to facilitate locating the balloon within a patient (Fig. 21; col. 25, ll. 45-62).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the balloon to have a magnet, in view of Connors, in order to facilitate locating the balloon within a patient for adjustment and/or retrieval.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Connors in view of Yachia et al. (U.S. Patent Application Publication No. 20050131442; hereinafter “Yachia”).
Regarding claim 17, Connors discloses the invention substantially as claimed, except for the retrieval device including a needle, a spring-biased plunger, and a locking mechanism.
Yachia, a reference in the medical device insertion and retrieval field of endeavor, teaches providing as system with a retrieval device (Figs. 5A-5D) including:
(a) a needle (230) that is movable between a retracted position (Figs. 5A-5B), and an extended position (Figs. 5C-5D);
(b) a plunger (280) attached to the needle, the plunger being spring biased by a spring (252) in the extended position; and
(c) a locking mechanism (including tongue (268) and notch (272); Fig. 5B; para. [0086]) allowing the needle to be intermittently locked in the retracted position (para. [0086])
to safely position the retrieval device with a patient to rapidly deflate and remove a balloon (para. [0086]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the retrieval device to include (a) a needle that is movable between a retracted position, and an extended position; (b) a plunger attached to the needle, the plunger being spring biased by a spring in the extended position; and (c) a locking mechanism allowing the needle to be intermittently locked in the retracted position, in view of Yachia, in order to facilitate safe and rapid deflation of a balloon for removal from a patient.
Response to Arguments
Applicant's arguments filed May 26, 2026 have been fully considered but they are not persuasive.
On pages 8-9 of the Response, Applicant argues that Connors does not disclose a “tubular capsule releasably attached or adapted to be releasably attached to a distal tip of the shaft,” as now recited in claim 1. This argument is not persuasive.
Connors discloses that inner sheath (372) is attached to the distal end/tip of outer sheath (374) so as to be released from the distal end/tip of the outer sheath by proximal movement of the outer sheath; Figs. 34A-34B).
Thus, the inner sheath constitutes a tubular capsule releasably attached or adapted to be releasably attached to a distal tip of the shaft, as recited in claim 1.
For the reasons above, Examiner maintains that the claimed invention is not allowable over the prior art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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, Elizabeth Houston can be reached at (571) 272-7134. 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.
/JONATHAN A HOLLM/Examiner, Art Unit 3771
Prosecution Insights