DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 11 September 2025.
Notice of 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 Arguments
Claim 1:
Applicant argues Katz’817 does not disclose the balloon 16 has a cylindrical shape when in a deflated shape, as required by amended claim 1. This argument is not persuasive. Katz’817’s balloon 16 is substantially cylindrical in the collapsed configuration – see Figures 1-3. Further, the modification of a device’s shape has been held to be an obvious modification: MPEP 2144 Section IV(B) cites In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966): The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. In this case, the specification does not disclose any advantage or benefit of a balloon having a cylindrical shape in the collapsed configuration.
Applicant argues the cylindrical shape of the deflated balloon facilitates passing the balloon by an obstruction. However, MPEP 716.01(c) states “Arguments presented by the applicant cannot take the place of evidence in the record.” In this case, Applicant’s arguments cannot be used to show criticality of a claimed feature. Since changes in shape are considered to be a routine modification, Katz’817 renders the claim obvious.
Claim 9
Applicant argues Katz’817 does not disclose the balloon 16 has an elongated exterior shape when deflated - similar to an exterior shape of the catheter because balloon 16 has an irregular shape and does not having an elongated exterior shape similar to the exterior shape of the catheter. This argument is not persuasive.
Katz’817 shows the balloon 16 has an elongated exterior shape in the deflated configuration – see Figures 1-3 which show the balloon 16 is elongated – i.e. greater in length than width. Further the term “similar” does not mean the shape is exactly the same and the slight irregularity shown in Figures 1 and 3 is considered to anticipate the limitation “the balloon, when deflated, has an elongated exterior shape similar to an exterior shape of the catheter”.
Claim 15:
Applicant argues Katz’817 does not disclose the bulb has a grip portion because it has a smooth outer profile. This argument is not persuasive because the claim recites “a grip portion to facilitate engagement by thereof by a user”, which only requires an area which can be gripped. It does not necessarily require textured surface to further enhance grip.
Therefore claim 15 is rejected under 35 USC 102 to Katz’817. However, to advance prosecution, an alternate rejection under 35 USC 103 to Katz’817 in view of Berk’195 is included to render a bulb with a textured grip portion obvious.
Claims 14, 20, 21
Applicant further argues Katz does not disclose “the bulb and the catheter comprise one unitary device” as required by dependent claims 14, 20 and 21.
Applicant argues paragraph [0027] of the specification discloses the bulb 11...is attached to the catheter 14 via a nipple, or, for example, formed as a unitary item along with catheter 10”, while Katz’s bulb 12 is connected to the catheter 14 via a nipple and therefore not a unitary element. This argument is not persuasive because independent claims 1, 9 and 15 – from which claims 14, 20, and 21 depend - each require the bulb and catheter are connected via a nipple. Katz’s Figure 1 clearly shows the bulb and catheter are assembled together to form a single, unitary device.
Further, it has been held that making two connected elements integral is an obvious modification. See MPEP 2144.04 Section V(B).
Claim Objections
Claim 9 objected to because of the following informalities: claim 9 reads “when deflated,3 has an…”. This is a typographical error and should read “when deflated, Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 9 recites the limitation "the balloon, when deflated, has an elongated exterior shape similar to the exterior shape of the catheter".
The term “similar” not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The definition of similar is “resembling without being identical”. However, this is essentially a term of degree and it unclear how closely the shape of the balloon must resemble the shape of the catheter to read on the claim.
Claims 10-14 are rejected based on their dependency from claim 9.
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 9 and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Katz (US Patent 5,454,817).
Claim 9: Katz’817 discloses a device (10; Figures 1-5), comprising:
a bulb (12) comprising a walled chamber portion (18) having a nipple (22) coupled thereto or formed as part thereof;
a catheter (14) configured to engage the nipple of the bulb at a first catheter end (29) (Figure 1; column 4, line 32); and
a balloon (16) positioned at a second catheter end opposite the first catheter end (Figure 1);
wherein when the bulb is compressed, air from within the bulb is pushed from the bulb, through the catheter, and into the balloon to inflate the balloon (Figure 4 and column 3, lines 20-23);
wherein the balloon (16), when deflated, has an elongated exterior shape similar to an exterior shape of the catheter (14) (Figures 1, 3 show the balloon 16 is longer than wide and closely resembles the shape of the catheter).
Claim 12: Katz’817 discloses the bulb comprises a flexible, semi-rigid material so to permit the bulb to be compressed and released, returning to a native configuration when released (column 4, lines 6-18).
Claim 13: Katz’817 discloses the balloon is sized and shaped to fit within a nasal cavity or an ear cavity when fully inflated (column 3, lines 1-12).
Claim 14: Katz’817’s bulb and catheter are a unitary device (Figures 1, 2).
Claim Rejections - 35 USC § 102/103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5-8, 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Katz (US Patent 5,454,817) or, in the alternative, under 35 USC 103 as being obvious over Katz’817.
Claim 1: Katz’817 discloses a device (10; Figures 1-5), comprising:
a bulb (12) comprising a walled chamber portion (18) having a nipple (22) coupled thereto or formed as part thereof;
a catheter (14) configured to engage the nipple of the bulb at a first catheter end (29) (Figure 1; column 4, line 32); and
a balloon (16) positioned at a second catheter end opposite the first catheter end (Figure 1);
wherein when the bulb is compressed, air from within the bulb is pushed from the bulb, through the catheter, and into the balloon to inflate the balloon (Figure 4 and column 3, lines 20-23).
In the deflated configuration, the balloon is substantially cylindrical (Figures 1-3). Further, if that is not persuasive, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention modify the shape of Katz’817’s deflated balloon so that it is cylindrical because it has been held that changes in shape are a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular shape is significant. See MPEP 2144.04 Section IV(B). In this case, the specification provides no advantage to having a balloon that it is cylindrical when deflated. Providing a cylindrical balloon without bunching in the collapsed configuration would provide the advantage of taking up less space in the nasal passage, and be easier to control since the balloon is taut and keeping mucus and other secretions from collecting in the folds/crevices of the collapsed balloon during insertion and being redeposited further into the nasal passage after the balloon is inflated.
Claim 5: Katz’817 discloses the bulb comprises a flexible, semi-rigid material so to permit the bulb to be compressed and released, returning to a native configuration when released (column 4, lines 6-18).
Claim 6: Katz’817 discloses the balloon is sized and shaped to fit within a nasal cavity or an ear cavity when fully inflated (column 3, lines 1-12).
Claim 7: Katz’817 discloses a method, comprising:
inserting part of the device of claim 1 (Figure 1 – see rejection of claim 1) into a nasal cavity or an ear cavity so that the balloon is positioned distal to an object present therein (Figure 9; column 5, lines 57-65);
inflating the balloon by compressing the bulb (column 5, lines 65-67; Figure 10); and
retracting the device from the nasal cavity or the ear cavity while maintaining compression of the bulb so that the balloon pulls the object out of the nasal cavity or the ear cavity (column 6, lines 1-6).
Claim 8: Katz’817 teaches releasing the compression of the bulb to deflate the balloon (column 4, lines 24-32).
Claim 21: Katz’817’s bulb and catheter are a unitary device (Figures 1, 2).
Claims 15 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Katz’817 or, in the alternative, under 35 USC 103 as being obvious over Katz’817 in view of Berk et al. (US Patent Application 2009/0187195).
Claim 15: Katz’817 discloses a device (10; Figures 1-5), comprising:
a bulb (12) comprising a walled chamber portion (18) having a nipple (22) coupled thereto or formed as part thereof;
a catheter (14) configured to engage the nipple of the bulb at a first catheter end (29) (Figure 1; column 4, line 32); and
a balloon (16) positioned at a second catheter end opposite the first catheter end (Figure 1);
wherein when the bulb is compressed, air from within the bulb is pushed from the bulb, through the catheter, and into the balloon to inflate the balloon (Figure 4 and column 3, lines 20-23);
wherein the bulb (12) defines a grip portion (exterior surface of the bulb) to facilitate engagement thereof by the user.
If it is not convincing that Katz’817’s bulb 12 defines a grip portion, Berk’195 teaches a device with a bulb (130) which is gripped and squeezed by a user to aid in removing a foreign object from the body. The bulb (130) is provided with a textured surface to create a grip portion (132) to enhance the user’s grip of the bulb (paragraph [0025]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the bulb taught by Katz’817 with a textured grip portion, as taught by Berk’195, in order to enhance the user’s grip of the bulb.
Claim 18: Katz’817 discloses the bulb comprises a flexible, semi-rigid material so to permit the bulb to be compressed and released, returning to a native configuration when released (column 4, lines 6-18).
Claim 19: Katz’817 discloses the balloon is sized and shaped to fit within a nasal cavity or an ear cavity when fully inflated (column 3, lines 1-12).
Claim 20: Katz’817’s bulb and catheter are a unitary device (Figures 1, 2).
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.
Claims 2, 4 are rejected under 35 U.S.C. 103 as being unpatentable over Katz’817, as applied to claim 1, further in view of Kao et al. (US Patent Publication 2004/0059233) and Borgeois et al. (US Patent 5,667,524).
Claims 10, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Katz’817, as applied to claim 9, further in view of Kao’233 and Borgeois’524.
Claims 16, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Katz’817 or Katz’817 in view of Berk’195, as applied to claim 15, further in view of Kao’233 and Borgeois’524.
Claims 2, 4 ,10, 11, 16, 17 : Katz’817 does not teach the bulb includes a valve.
Katz’817 uses a common inflation bulb to inflate the balloon. It is old and well known for such inflation bulbs to include a valve. For example, Kao’233 discusses a standard inflation bulb to inflate a cuff (Figures 1a-1d; paragraph [0005]). Like Katz’817, Kao’233’s bulb 100 comprises a thin-walled chamber having a nipple 120 connected to a catheter 10 for inflation of a cuff (paragraph [0005]). The bulb 100 includes a valve 130. When the bulb is not compressed, the valve (130) is open (Figures 1a, 1b and paragraph [0007]). When the bulb is compressed, the valve (130) closes so that air from within the bulb is pushed into catheter 10 to inflate the cuff (Figures 1c, 1d; paragraph [0008]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the bulb of Katz’817 with a valve, as taught by Kao’233, in order to allow more air into the system so the device does not fail or become inoperable for its intended purpose when the initial volume of air in Katz’817’s system diffuses through the walls of the system.
It is also well known to provide such inflation bulbs with a relief valve at the nipple in order to release air from the system. For example, Borgeois’524 teaches an inflation bulb 13 for inflating a cuff (1). The inflation bulb (13) includes a pressure relief valve (11) to allow excess air to escape from the system and prevent overinflation.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to provide the modified system of Katz’817 with a pressure relief valve, as taught by Borgeois’524, to allow the user to release excess air from the system.
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 extension fee 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 date of this final action.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 13 October 2025
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771