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.
Response to Amendment
The Response filed October 24, 2025 has been entered. Claims 1-19 are pending in the application. The previous rejections of claims under 35 U.S.C. 112(b) are withdrawn in light of Applicant’s amendments to the claims.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 Objections
Claim 19 is objected to because of the following informalities: the phrase “application according to claim 1” should read - - applicator according to claim 1 - -. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 recites inter alia a fillable balloon unfilled or partially filled state “folded and being rolled or crumpled in an interior of the capsule. The specification is silent as to a fillable balloon being “folded” and “rolled or crumpled,” as recited in claim 11. Thus, claim 11 contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
Claims 12-14 are rejected as being dependent upon rejected claim 11 and failing to remedy the written description issue.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6-16, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yachia et al. (U.S. Patent No. 6398718; hereinafter “Yachia ‘718”).
Regarding claim 1, Yachia ‘718 disclose an applicator (220) for delivering a fillable balloon into a body cavity (Figs. 16A-17B) comprising:
(a) a tubular shaft having a lumen (annotated Fig. 16A below);
(b) a tubular capsule (226) attached or adapted to be attached to a distal end of the shaft; the capsule having a lumen adapted to receive a balloon in an uninflated or unfilled or partially filled state (annotated Fig. 17A below); and,
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(c) a pusher (207) located in the lumen of the tubular shaft having a distal end adapted to be inserted into a valve of the balloon, the pusher being adapted to:
push the balloon out from the capsule lumen (syringe (207) is capable of pushing the balloon out; Figs. 16A-16B);
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. 7, ll. 28-67); and,
detach the balloon from the distal end of the pusher (col. 7, ll. 65-67).
Regarding claim 2, Yachia ‘718 discloses wherein the shaft has a slit in a wall of the shaft, exposing the lumen of the shaft to the exterior (annotated Fig. 17A below).
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Regarding claim 3, Yachia ‘718 discloses wherein the pusher includes a hollow tube with a needle at its distal end (Fig. 16A-16B; col. 7, l. 62-67).
Regarding claim 4, Yachia ‘718 discloses wherein the capsule is adapted to be attached to the shaft and to lock onto the distal end of the shaft (Fig. 17A; col. 8, ll. 8-10).
Regarding claim 6, Yachia ‘718 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. 8, ll. 10-15).
Regarding claim 7, Yachia ‘718 discloses wherein the capsule is straight (sleeve (226) extends straight in a longitudinal direction; Fig. 17A).
Regarding claim 8, Yachia ‘718 discloses wherein the capsule is curved (sleeve (226) is curved in a circumferential direction; Fig. 17A).
Regarding claim 9, Yachia ‘718 discloses wherein the applicator is adapted to treat a fistula (as applicator (220) is capable of treating a fistula in a bladder because the applicator is structured for insertion into a patient’s bladder and no structure of the applicator would prevent its use to treat a fistula in the bladder.
Regarding claim 10, Yachia ‘718 disclose a balloon (200) for use in the applicator according to claim 1 (Fig. 16A), having a magnet (115; col. 7, ll. 48-54)).
Regarding claim 11, Yachia ‘718 discloses a capsule (226; Fig. 17A) for use in the applicator according to claim 1, having a fillable balloon (200) in an unfilled or partially filled state folded and being rolled or crumpled in an interior of the capsule (annotated Fig. 16A below).
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Regarding claim 12, Yachia ‘718 discloses wherein the capsule is straight (sleeve (226) extends straight in a longitudinal direction Fig. 17A).
Regarding claim 13, Yachia ‘718 discloses wherein the capsule is curved or bent (sleeve (226) is curved in a circumferential direction; Fig. 17A).
Regarding claim 14, Yachia ‘718 discloses wherein the balloon has a magnet (115; col. 7, ll. 48-54).
Regarding claim 15, Yachia ‘718 discloses a system for delivering a fillable balloon into a body cavity (Figs. 16A-17B) comprising:
(a) an applicator according to claim 1 (explained above in this Office Action with respect to the rejection of claim 1); and
(b) one or more balloons (200) configured to be folded or rolled in the lumen of the capsule of the applicator (Fig. 16A; as balloon (200) formed of flexible material and deformed to fit within applicator (220), the balloon is structured to be capable of being folded or rolled in the lumen of the capsule).
Regarding claim 16, Yachia ‘718 discloses the system further comprising a retrieval device (230; Fig. 18) configured to deflate a filled balloon in the body cavity and to remove the balloon from the body cavity (col. 8, ll. 22-33).
Regarding claim 19, Yachia ‘718 discloses wherein the tubular shaft and the tubular capsule are configured in a side-by-side configuration (Fig. 17A; the interior side of sleeve (226) is positioned next to the exterior side of the tubular shaft of applicator (220); thus, they are in a “side-by-side” configuration).
Claims 18-19 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 18, 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 (732) attached or adapted to be attached to a distal end of the shaft (Fig. 34A); 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) and
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 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 (732) attached or adapted to be attached to a distal end of the shaft (Fig. 34A); 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) and
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Yachia ‘718 in view of Weldon et al. (U.S. Patent No. 5419765).
Regarding claim 5, Yachia ‘718 discloses the invention substantially as claimed, except for the pusher being a canula (206) pre-attached to a syringe (207; Fig. 16A) instead of a pusher connected to a male Luer connector at the proximal end of the pusher.
Weldon, a reference in the medical device insertion field of endeavor, teaches that a pusher being pre-attached to a syringe (col. 10, ll. 8-9) is an equivalent structure known in the art with a pusher is connected to a male Luer connector at the proximal end of the pusher (Figs. 19A-19D; col. 9, ln. 49 – col. 10, ln. 13) for delivering an inflatable device (64) within a patient.
Therefore, because these two pusher configurations were art-recognized equivalents before the effective filing date of the claimed invention, a person having ordinary skill in the art would have found it obvious to substitute a pusher that is connected to a male Luer connector at the proximal end of the pusher for pusher of Yachia ‘718 to achieve the predictable result of delivering the inflatable device within a patient since the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Yachia ‘718 in view of .Yachia et al. (U.S. Patent Application Publication No. 20050131442; hereinafter “Yachia ‘442”).
Regarding claim 17, Yachia ‘718 discloses the invention substantially as claimed, except for the retrieval device including a needle, a spring-biased plunger, and a locking mechanism.
Yachia ‘442, 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 ‘442, in order to facilitate safe and rapid deflation of a balloon for removal from a patient.
Response to Arguments
Applicant's arguments filed October 24, 2025 have been fully considered but they are not persuasive.
On pages 5-7 of the Response, Applicant argues that Yachia ‘718 does not anticipate claim 1. These arguments are not persuasive.
On pages 5-6 of the Response, Applicant argues that that the rejection improperly “points to two embodiments in Yachia '718” by referring to Figs. 16A-17B in the rejection (Response pg. 6). This argument is not persuasive.
Figs. 16A-17B of Yachi ‘718 and descriptive text refer to the same applicator (220). Col. 8, ll. 1-15 of Yachia ‘718 discloses
As shown in FIG.16, the balloon may first be inserted into the bladder by means of an applicator 220 to be described below in detail (FIG. 16a) and following its release from the applicator into the bladder, the balloon is then filled with fluid 224 from a syringe 207 (FIG. 16b). Alternatively, as shown in FIG. 17a, the balloon 200 may be filled and compressed . . . means of applicator 220.
(Bolding added). Furthermore, Figs. 16A and 17A both include reference numeral “220” pointing to the disclosed applicator. Thus, Yachia ‘718 discloses that applicator (220) is present in Fig. 16A and Fig. 17A.
The use of the term “Alternatively” in col. 8, ln. 5 of Yachia ‘718 appears to refer to the unfilled or filled condition of balloon (200).
Hence, Figs. 16A-17B of Yachia ‘718 depict the same applicator (220). Therefore, the prior art rejection of claim 1 referring to applicator (220) as depicted in Figs. 16A-17B does not improperly rely on alternative embodiments.
On pages 6-7 of the Response, Applicant argues that Yachia ‘718 “cannot be considered similar to the tubular capsule” (Response pg. 6) as recited in claim 1. This argument is not persuasive.
Claim 1 recites inter alia “a tubular capsule attached or adapted to be attached to a distal end of the shaft; the capsule having a lumen adapted to receive a balloon in an uninflated or unfilled or partially filled state.” Sleeve (226) of Yachia ‘718 meets all the recitations of the claimed tubular capsule.
Sleeve (226) of Yachia ‘718 is depicted as having a tubular structure (Figs. 17A-17B) and being attached to the distal end of the shaft of applicator (220). Thus, sleeve (226) is a tubular capsule “attached or adapted to be attached to a distal end of the shaft.” Also, Fig. 17A of Yachia ‘718 depicts balloon (200) fitting within a lumen defined by the inner diameter of tubular sleeve (226). Thus, sleeve (226) also has “a lumen adapted to receive a balloon in an uninflated or unfilled or partially filled state,” as recited in claim 1.
Therefore, the tubular sleeve (226) of Yachia ‘718 meets all the recitations of the claimed tubular capsule.
Applicant’s further argument discussing the use of the tubular sleeve of Yachia ‘718 (Response pp. 6-7) is inapposite because Applicant’s characterization of the use of tubular sleeve (226) does not undermine the Examiner’s finding that the tubular sleeve meets the structural limitations of the claimed tubular capsule.
For the above reasons, Examiner maintains that the invention of claim 1 is anticipated by the disclosure of Yachia ‘718.
On pages 7-8 of the Response, Applicant argues that Yachia ‘718 does not anticipate claim 10, because Yachia ‘718 does not meet the limitations of claim 1. This argument is not persuasive for the reasons above regarding Yachia ‘718 anticipating claim 1.
Examiner also notes that claim 10 merely functionally recites the applicator according to claim 1 (i.e., “for use in the applicator according to claim 1”). Thus, the applicator recited in claim 1 is not positively recited as a structural element of claim 10.
On page 8 of the Response, Applicant argues that Yachia ‘718 does not anticipate claim 11. These arguments are not persuasive.
Applicant argues that Yachia ‘718 does not anticipated claim 11 because Yachia ‘718 does not meet the limitations of claim 1 (Response pp. 7-8). This argument is not persuasive for the reasons above regarding Yachia ‘718 anticipating claim 1.
On page 8 of the Response, Applicant further argues that Yachia ‘718 does not disclose a balloon in a “state folded and being rolled or crumpled in an interior of the capsule,” as recited in claim 11. This argument is not persuasive.
As can be seen in annotated Fig. 16A of Yachi ‘718 below, balloon (200) is folded and crumpled while in the interior of the applicator (220). Thus, the balloon is “in an unfilled or partially filled state folded and being rolled or crumpled in an interior of the capsule,” as recited in claim 11.
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On page 9 of the Response, Applicant argues that Yachia ‘718 does not anticipate claim 15.
Applicant argues that Yachia ‘718 does not anticipated claim 15 because Yachia ‘718 does not meet the limitations of claim 1 (Response pg. 9). This argument is not persuasive for the reasons above regarding Yachia ‘718 anticipating claim 1.
On page 9 of the Response, Applicant further argues that Yachia ‘718 does not disclose a balloon configured to be folded or rolled, as recited in claim 15. This argument is not persuasive.
Claim 15 recites inter alia one or more balloons “configured to be folded or rolled in the lumen of the capsule.” This limitation is interpreted as a functional limitation because it recites what the balloon does rather than what the balloon is.
Here, Yachia ‘718 discloses balloon (200) being formed of flexible material and deformed to fit within applicator (220).
Further, no structure in the device of Yachia ‘718 would prevent the balloon from performing the claimed function of being folded or rolled in applicator (220).
Thus, the balloon is structured to be capable of performing the claimed function of being “folded or rolled in the lumen of the capsule,” as recited in claim 15. Therefore, balloon (200) meets the recitations of claim 15.
On pages 10-11, Applicant argues that the proposed combination of Yachia ‘718 and Weldon does not render obvious the invention of claim 5. Specifically, Applicant argues that neither Yachia ‘718 nor Weldon discloses all the limitations of claim 1 (Response pp. 10-11), from which claim 5 depends. This argument is not persuasive because Yachia ‘718 anticipates the recitations of claim 1, as explained above in this Office Action.
On pages 11-12, Applicant argues that the proposed combination of Yachia ‘718 and Yachia ‘442 does not render obvious the invention of claim 17. Specifically Applicant argues that neither Yachia ‘718 nor Yachia ‘442 discloses all the limitations of claim 1 (Response pp. 11-12), from which claim 17 depends. This argument is not persuasive because Yachia ‘718 anticipates the recitations of claim 1, as explained above in this Office Action.
Applicant’s arguments with respect to new claim 18 (Response pg. 13) have been considered but are moot because the new ground of rejection over Connors does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s argument that Yachia ‘718 does not disclose the recitations of new claim 19 (Response pg. 13) is not persuasive.
Claim 19 recites inter alia “the tubular shaft and the tubular capsule are configured in a side-by-side configuration.” This limitation is met by the applicator (220) of Yachia ‘718.
As can be seen in Fig. 17A of Yachia ‘718, the interior side of sleeve (226) is positioned next to the exterior side of the tubular shaft of applicator (220). Thus, they are in a “side-by-side” configuration.
Therefore, applicator (220) of Yachia ‘718 meets all the recitations of claim 19 and Yachia ‘718 anticipates claim 19.
On pg. 14 of the Response, Applicant argues that dependent claims 2-9, 12-14, and 16-17 are allowable as being dependent upon an allowable claim. This argument is not persuasive because none of the claims are allowable over the prior art of record, as explained above in this Office Action.
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 Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/J.A.H/Jonathan HollmExaminer, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771