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 in response to the amendment filed on 11/10/2025. As directed by the amendment, claims 3-4 and 7-8 were canceled, claims 1, 5, 9-10, 12, 18, and 20 were amended, and no claims were newly added. Thus, claims 1-2, 5-6, and 9-20 are presently pending in this application.
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 1-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1 line 20, the term “a net flow of inflation fluid” is unclear as to if the term is the same or different than line 17.
Any remaining claims are rejected as being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 1-2, 9-15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Peddicord (US 2013/0131772) in view of Murison (US 2014/0088468) and Singh (US 2013/0233321).
Regarding claim 1, Peddicord discloses an enhanced dilatation device (see Peddicord medical device 100; Fig. 1, 5), the enhanced dilatation device comprising:
a rigid elongated member (see Peddicord probe assembly 102, comprising handle 110 and probe 120) having a proximal end (see Peddicord end closest to probe 120), distal end (see Peddicord end closest to handle 110), and a shaft region therebetween (see Peddicord shaft 210);
a sheath secured to and at least partially enclosing at least a portion of an exterior of the shaft region (see Peddicord balloon 124), the sheath having an outer surface (see Peddicord outer surface 126) and an inflation lumen (see Peddicord lumen or cavity 530), the inflation lumen being transitionable between at least a deflated configuration and an inflated configuration (see Peddicord [0020] “The balloon 125 may be inflated to a plurality of different inflated positions between fully deflated and fully inflated”), wherein transitioning of the inflation lumen to the inflated configuration is operative to cause an inflation portion of the outer surface to expand away from the exterior of the shaft region (see Peddicord Fig. 6B inflated state, balloon 124 is labeled where outer surface 126 is the outside of balloon 124 and has expanded), and wherein transitioning of the inflation lumen to the deflated configuration is operative to cause the inflation portion of the outer surface to retract towards the exterior of the shaft region (see Peddicord Fig. 6A deflated state, balloon 124 with outer surface 126 has deflated/compressed);
a conduit defining an inflation fluid pathway between the reservoir and the inflation lumen (see Peddicord tube 222).
Peddicord discloses a motorized pump (see Peddicord [0045]), but is silent as to the details such as a reservoir operative to contain inflation fluid and a pump associated with the inflation fluid pathway, the pump being operative to regulate the flow of inflation fluid between the reservoir and the inflation lumen, a net flow of inflation fluid from the reservoir into the inflation lumen being associated with the transition of the inflation lumen to the inflated configuration, and a net flow of inflation fluid from the inflation lumen into the reservoir being associated with the transition of the inflation lumen to the deflated configuration. However, Murison teaches a reservoir operative to contain inflation fluid (see Murison [0201] compartment 1510 contains reservoir); and a pump associated with the inflation fluid pathway (see Murison [0201] compartment 1510 contains fluidic pump), the pump being operative to regulate the flow of inflation fluid between the reservoir and the inflation lumen (see Murison [0201] fluidic pump… necessary to control the fluidic flow to the fluidic chambers), a net flow of inflation fluid from the reservoir into the inflation lumen being associated with the transition of the inflation lumen to the inflated configuration (see Murison [0201] “in second state 1500B each of the first to fourth fluidic chambers 1540A through 1540D has been pressurized from the fluidic pump expanding the first to fourth fluidic chambers 1540A through 1540D”), and a net flow of inflation fluid from the inflation lumen into the reservoir being associated with the transition of the inflation lumen to the deflated configuration (see Murison [0201] state 1500A shows deflated chambers 1530A-D). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosed motorized pump of Peddicord with the specific motorized pump and reservoir as taught by Murison as this would have been an obvious substitution for one known type of motorized pump within an dilation device for another and would yield predictable results, i.e. function to operate the device’s inflation/deflation.
Modified Peddicord discloses a control unit being operative to control operation of the pump (see Peddicord Controller 104, Fig. 8);
a pressure sensor for determining a pressure within the inflation unit (see Peddicord pressure sensor 520); wherein the control unit is configured to operate the pump in response to determination of a pressure within the inflation lumen by the pressure sensor in order to cause transition of the inflation lumen to or from the inflated or deflated configuration (see Peddicord [0046] pressure sensor 520 communicates with processing electronics 800 within controller 104 which controls balloon 124; [0071] pressure data from 520 effects inflation/deflation of balloon 124).
Modified Peddicord is silent as to an accelerometer for detecting motion of the enhanced dilation device; and wherein the control unit is configured to operate the pump in response to detection of motion by the accelerometer in order to cause transition of the inflation lumen to or from the inflated or deflated configuration. However, Singh teaches an accelerometer for detecting motion of the enhanced dilation device (see Singh [0055] body insertion” sensors such as motion detection sensors (e.g. and accelerometer); indicates when cuffs are inflatable); and wherein the control unit is configured to operate the pump in response to detection of motion by the accelerometer in order to cause transition of the inflation lumen to or from the inflated or deflated configuration (see Singh [0068] motion detector sensors indicate insertion and readiness, which can automatically trigger activation of pumps to inflate/deflate the cuffs). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller of modified Peddicord with the addition of an accelerometer to the control unit system as taught by Singh so as to more safely and accurately trigger inflation/deflation of the device.
Regarding claim 2, modified Peddicord discloses the reservoir is enclosed within the rigid elongated member (see Murison modification Claim 1 compartment 1510 contains reservoir within device).
Regarding claim 9, modified Peddicord discloses the control unit is configured to operate the pump so as to cause the inflation lumen to transition between the inflated and deflated configurations in response to a determination that the pressure within the inflation lumen is above or below one or more predefined pressure levels (see Peddicord [0071] Pressure module 940 receives information from pressure sensor 520; pressure module 940 changes how processing electronics 800 change pressure in balloon 124 around a threshold value).
Regarding claim 10, modified Peddicord discloses the control unit is configured to operate the pump in response to determinations of pressure changes within the inflation lumen in order to maintain a consistent internal volume of the inflation lumen (see Peddicord [0071] pressure module 940 ensuring balloon 124 is sufficiently inflated, meaning a consistent internal volume would be monitored that keeps a sufficient inflation).
Regarding claim 11, modified Peddicord discloses a stimulatory module adapted to provide additional stimulation (see Peddicord Fig. 8 vibration motor 804).
Regarding claim 12, modified Peddicord discloses the stimulatory module comprises a vibrational element (see Peddicord Fig. 8 vibration motor 804).
Regarding claim 13, modified Peddicord discloses a power supply for supplying power to at least the pump (see Peddicord Fig. 8 power supply 808).
Regarding claim 14, modified Peddicord discloses the power supply comprises a rechargeable battery (see Peddicord [0059] power supply 808 may be a rechargeable battery).
Regarding claim 15, modified Peddicord discloses a pressure release valve associated with the inflation lumen (see Peddicord Fig. 5 release valve 208, [0045] prevent over-pressurization of balloon 124).
Regarding claim 19, modified Peddicord discloses the control unit is configured to receive inputs from a user to control the functionality of the enhanced dilatation device (see Peddicord Fig. 7 controller 104 with buttons 704 for user input [0049]).
Regarding claim 20, modified Peddicord discloses the control unit comprises as wireless receiver for permitting a user to wirelessly control the functionality of the enhanced dilatation device (see Peddicord [0034] controller 104 may be wireless to communicate with probe assembly 102).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Peddicord in view of Murison and Singh as applied to claim 1 above, and further in view of Alexander et al. (US 9,861,800; hereinafter “Alexander”).
Regarding claim 16, modified Peddicord is silent as to the inflation fluid comprises helium. However, Alexander teaches the inflation fluid comprises helium (see Alexander Col. 16 lines 55-58 inflation cartridges 1400, 1500 may be charged with a medically approved gas such as helium). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inflation fluid of air of Peddicord with the inflation fluid of helium as taught by Alexander as this would have been an obvious substitution for one known type of inflation fluid for another and would yield predictable results, i.e. inflating the lumen.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Peddicord in view of Murison and Singh as applied to claim 1 above, and further in view of Murison.
Regarding claim 17, modified Peddicord discloses the enhanced dilatation device comprises two or more inflation lumens (see Peddicord lumen 530 in Fig. 5 appears to branch into two sides of the device, as two lumens). Even if modified Peddicord does not disclose the limitation, however, Murison teaches the enhanced dilatation device comprises two or more inflation lumens (see Murison Fig. 15A chambers 1530A-D and inflated 1540A-D). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lumen of modified Peddicord with the multiple lumen as taught by Murison since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art, such as the amount of lumen. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 18, modified Peddicord discloses each of the two or more inflation lumens is independently transitionable between at least a deflated configuration and an inflated configuration (see Murison [0201] chambers 1540A-D are controllable by “variety simultaneous expansion, sequential expansion from one end of the sexual pleasure device to another, random expansion, and rippling expansion”).
Allowable Subject Matter
Claims 5-6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive.
Applicant’s arguments, see pages 8-9 of the remarks, with respect to the rejection(s) of claims 1, 3-4, and 7-8 under previous 102 and 103 rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 USC 103 combining previous and new references, see rejection under Peddicord in view of Murison and Singh above.
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 GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
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/GWYNNETH L HOWELL/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785