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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/10/2026 has been entered.
Response to Amendments
The Amendment filed 07/10/2026 has been entered.
Claims 2, 15, and 17-29 are cancelled.
Claims 1, 3-14, and 16 remain pending in the application.
Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Final Office Action mailed 01/13/2026.
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.
Claims 1, 6-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Vlodaver et al. (U.S. Patent Pub. 20110301572), hereinafter Vlodaver, in further view of Johnson et al. (U.S. Patent Pub. 20090266369), hereinafter Johnson.
Regarding claim 1, Vlodaver discloses an earplug (earplug 14 with syringe 100; see FIG. 18; the Examiner notes that all reference characters cited below refer to FIG. 18 unless otherwise stated) for administering a fluid agent (fluid 12) into an ear canal (“ear medication delivery device for delivering a treatment liquid and retaining the treatment liquid within an ear canal of a patient”, Abstract), the earplug comprising:
a first part (earplug 14 with syringe 100) adapted for insertion in the ear canal, the first part including
an elongated member (tube 32) having a chamber (lumen 24 and inside of syringe 100) for containing the fluid agent, the chamber having at least one outlet (proximal end 30 of lumen 24) at a proximal end of the elongated member (see FIG. 18), and
a malleable member (outer body 22; “body 22 is preferably relatively frustoconical in shape, made of a somewhat pliable hypoallergenic material that is non-reactive with the tissue of the external ear canal like compressible resilient elastomeric foam, rubber, silicone, silicone putties, vinyl or acrylics”, [0068]) disposed laterally of the elongated member (see FIG. 18); and
a second part (moving portion of syringe 100) including a piston (plunger mechanism on the syringe, see [0106]), the piston having
a first end which is insertable in the elongated member (see plunger end in contact with fluid 12 in FIG. 18), and
a second end which has a push member (see proximal end of syringe 100);
wherein the piston is displaceable from a first position distally of the chamber to a second position within the chamber, such that the fluid agent is injected from the chamber through the outlet into the ear canal (“In either variant, when it is desired to use the device 10 and therefore supply treatment fluid 12 to the device 10, the syringe 100 is connected to the earplug 14 as described. Thereafter, the plunger mechanism on the syringe 100 is activated to move treatment fluid 12 from the syringe 100 to the earplug 14 to exit the earplug 14 at the orifice 34 as described above.”, [0106])
wherein, when the earplug is positioned in the ear canal of a person prior to injection of the fluid agent into the ear canal of the person, the chamber and the fluid agent contained therein are positioned in the ear canal of the person (“the earplug 14 is placed into the patient's external ear canal 26 so that the portions of the outer body 22 nearer the proximal end 20 of the earplug 14 comes into sealing contact with the patient's external ear canal 26”, [0124]).
However, Vlodaver does not expressly state wherein, when the earplug is positioned in the ear canal of the person and the piston is in the second position within the chamber, the piston is positioned in the ear canal of the person.
Johnson teaches an earplug insertion device (Abstract) when the earplug is positioned in the ear canal of the person and the piston is in the second position (see [0073]) within the chamber, the piston is positioned in the ear canal of the person (“ A front portion of the cylindrical body (422) of the plunger/guide (420) can extend into a rear portion of the guide (412).”, [0070]; see FIG. 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the piston of Vlodaver wherein when the earplug is positioned in the ear canal of the person and the piston is in the second position within the chamber, the piston is positioned in the ear canal of the person. Doing so allows for the syringe to eject an earplug further within the ear canal while avoiding inadvertently being pushed too far forward, as taught by Johnson, (see [0070-0073]).
Regarding claim 6, Vlodaver in view of Johnson teaches the claimed invention as discussed above concerning the rejection of claim 1, and Vlodaver further discloses the malleable member (outer body 22) is fabricated from a material selected from the group consisting of silicone rubber, neoprene, and ethylene propylene diene monomer rubber (“body 22 is preferably relatively frustoconical in shape, made of a somewhat pliable hypoallergenic material that is non-reactive with the tissue of the external ear canal like compressible resilient elastomeric foam, rubber, silicone, silicone putties, vinyl or acrylics”, [0068]).
Regarding claim 7, Vlodaver in view of Johnson teaches the claimed invention as discussed above concerning the rejection of claim 1, however, this embodiment of Vlodaver seen in FIG. 18 does not expressly state wherein the malleable member has a plurality of resilient flanges distributed in a longitudinal main direction of the malleable member.
Vlodaver teaches an alternate embodiment in FIGS. 21-27 wherein the malleable member (ear canal engaging portion 126; “ear canal engaging portion 126 is composed of a soft, molded, resilient material such as silicone, polyurethane, or another FDA-approved biocompatible material”, [0134]) has a plurality of resilient flanges (disk 134, 136, 138, 140) distributed in a longitudinal main direction of the malleable member (see FIG. 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the malleable member of Vlodaver seen in the embodiment of FIG. 18 to include a plurality of resilient flanges distributed in a longitudinal main direction of the malleable member. Doing so provides a resilient seal within the wall of the external ear canal, as taught by Vlodaver, (see [0142]).
Regarding claim 8, the combination of the embodiments seen in FIGS. 18 and 21-27 of Vlodaver in view of Johnson teach the claimed invention as discussed above concerning the rejection of claim 7, and the embodiment seen in FIGS. 21-27 of Vlodaver further teach wherein the plurality of resilient flanges (disk 134, 136, 138, 140) of the malleable member (ear canal engaging portion 126) have decreasing radial sizes (see FIG. 21), a first flange (disk 134) at or near the proximal end of the elongated member having a smallest radial size and a last flange (disk 140) at or near a distal end of the elongated member having a largest radial size (see FIG. 21).
Regarding claim 9, Vlodaver in view of Johnson teaches the claimed invention as discussed above concerning the rejection of claim 1, and Vlodaver further discloses wherein the piston (plunger mechanism on the syringe, see [0106]) has a sealing member (gasket, see claim 2; see gasket of plunger in syringe 100 in FIG. 18) near or at the first end (the Examiner notes the gasket of syringe 100 will be near or at the first end once the plunger is pushed to administer fluid).
Regarding claim 10, Vlodaver in view of Johnson teaches the claimed invention as discussed above concerning the rejection of claim 9, and Vlodaver further discloses wherein the sealing member comprises an o-ring gasket (“unitary annular gasket”, see claim 2; see gasket of plunger in syringe 100 in FIG. 18); and wherein the piston has a circumferential groove near or at the first end for receiving the o-ring gasket (see Examiner annotated FIG. 18 below).
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Regarding claim 11, Vlodaver in view of Johnson teaches the claimed invention as discussed above concerning the rejection of claim 9, however, Vlodaver does not expressly state wherein the elongated member has a circumferential groove near or at a distal end of the elongated member, the circumferential groove being configured for receiving at least a part of the sealing member of the piston in the first position of the piston. The Examiner notes Vlodaver FIG. 18 teaches a syringe 100 having distal end 102 configured to mate with end 20 in a male female configuration (see [0105]). The distal end 102 having a male configuration and tube 32 and end 20 having a female configuration will sufficiently teach a circumferential groove near or at a distal end of the elongated member. In the position wherein the plunger of syringe 100 has been maximally pushed to administer fluid, the sealing member will be received in the distal end 102 of the syringe which is received in the tube 32 and end 20.
Regarding claim 12, Vlodaver in view of Johnson teaches the claimed invention as discussed above concerning the rejection of claim 1, however, this embodiment of Vlodaver seen in FIG. 18 does not expressly state the earplug further comprising a third part: wherein the first part is disposed between the second and the first parts of the earplug, the third part being a removable obstructor of the outlet of the elongated member.
Vlodaver teaches an alternate embodiment in FIG. 17 wherein the earplug (earplug 14) further comprising a third part (cap 98): wherein the first part is disposed between the second and the first parts of the earplug (see FIG. 17 where 64 is located, “valve 64 in the lumen 24 of earplug 14 may be eliminated and replaced with a cap 98”, [0104]), the third part being a removable obstructor of the outlet (proximal end 30 of lumen 24) of the elongated member (“The function of cap 98 is to close the proximal end 30 of lumen 24 once the treatment fluid 12 has been delivered”, [0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the earplug of Vlodaver seen in the embodiment of FIG. 18 to include a third part: wherein the first part is disposed between the second and the first parts of the earplug, the third part being a removable obstructor of the outlet of the elongated member. Doing so provides a seal for the earplug after the fluid is finished being delivered, as taught by Vlodaver, (see [0104]).
Regarding claim 13, the combination of the embodiments seen in FIGS. 17-18 of Vlodaver in view of Johnson teach the claimed invention as discussed above concerning the rejection of claim 12, and the embodiment seen in FIG. 17 of Vlodaver further teach wherein the third part comprises a twistable cap (cap 98).
Regarding claim 14, Vlodaver discloses a method of administering a liquid medicament to a person (see [0128]), the method comprising:
providing an earplug, the earplug (earplug 14 with syringe 100; see FIG. 18; the Examiner notes that all reference characters cited below refer to FIG. 18 unless otherwise stated) having an internal container for the liquid medicament (lumen 24 and inside of syringe 100), and an injector mechanism (see [0089]);
inserting the earplug in an ear canal of the person (“earplug 14 is inserted into the patient's external ear canal 26”, [0089]);
actuating the injector mechanism to cause injection of the liquid medicament from the internal container of the earplug to the ear canal of the person (“Thereafter, the plunger mechanism on the syringe 100 is activated to move treatment fluid 12 from the syringe 100 to the earplug 14 to exit the earplug 14 at the orifice 34”, [0106]);
leaving the earplug in place in the ear canal for a duration of treatment (“delivering and retaining the treatment fluid in contact with the patient's external ear canal or eardrum for a desired time period to provide a therapeutic benefit or to deliver treatment fluid to a patient's external ear canal”, [0019]; and
removing the earplug from the ear canal when the duration of treatment has lapsed (“The earplug 14 is then removed from the external ear canal 26 allowing the resulting mixture of treatment fluid 12 and wax debris or waste fluid 28 to drain out of the ear by gravity.”, [0090]).
wherein the earplug used in the method comprises:
a first part (earplug 14 with syringe 100) adapted for insertion in the ear canal, the first part having
an elongated member (tube 32) having a chamber (lumen 24 and inside of syringe 100) for containing the fluid agent, the chamber having at least one outlet (proximal end 30 of lumen 24) at a proximal end of the elongated member (see FIG. 18), and
a malleable member (outer body 22; “body 22 is preferably relatively frustoconical in shape, made of a somewhat pliable hypoallergenic material that is non-reactive with the tissue of the external ear canal like compressible resilient elastomeric foam, rubber, silicone, silicone putties, vinyl or acrylics”, [0068]) disposed laterally of the elongated member (see FIG. 18); and
a second part (moving portion of syringe 100) including a piston (plunger mechanism on the syringe, see [0106]), the piston having
a first end which is insertable in the elongated member (see plunger end in contact with fluid 12 in FIG. 18), and
a second end which has a push member (see proximal end of syringe 100);
wherein the piston is displaceable from a first position distally of the chamber to a second position within the chamber, such that the fluid agent is injected from the chamber through the outlet into the ear canal (“In either variant, when it is desired to use the device 10 and therefore supply treatment fluid 12 to the device 10, the syringe 100 is connected to the earplug 14 as described. Thereafter, the plunger mechanism on the syringe 100 is activated to move treatment fluid 12 from the syringe 100 to the earplug 14 to exit the earplug 14 at the orifice 34 as described above.”, [0106]);
wherein, when the earplug is positioned in the ear canal of a person prior to injection of the fluid agent into the ear canal of the person, the chamber and the fluid agent contained therein are positioned in the ear canal of the person (“the earplug 14 is placed into the patient's external ear canal 26 so that the portions of the outer body 22 nearer the proximal end 20 of the earplug 14 comes into sealing contact with the patient's external ear canal 26”, [0124]);
However, Vlodaver does not expressly state wherein, when the earplug is positioned in the ear canal of the person and the piston is in the second position within the chamber, the piston is positioned in the ear canal of the person.
Johnson teaches an earplug insertion device (Abstract) when the earplug is positioned in the ear canal of the person and the piston is in the second position (see [0073]) within the chamber, the piston is positioned in the ear canal of the person (“ A front portion of the cylindrical body (422) of the plunger/guide (420) can extend into a rear portion of the guide (412).”, [0070]; see FIG. 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the piston of Vlodaver wherein when the earplug is positioned in the ear canal of the person and the piston is in the second position within the chamber, the piston is positioned in the ear canal of the person. Doing so allows for the syringe to eject an earplug further within the ear canal while avoiding inadvertently being pushed too far forward, as taught by Johnson, (see [0070-0073]).
Regarding claim 16, Vlodaver in view of Johnson teaches the claimed invention as discussed above concerning the rejection of claim 14, and Vlodaver further discloses wherein the method is a method for treating an indication selected from the group consisting of sleep disorders; stress disorders; nicotine dependency; pain; heart disorders; vitamin insufficiency; motion sickness; blood pressure deviations; mood disorders; hormone deviations; weight gain; urination disorders; Parkinson's disease (PD); Alzheimer's disease; and nausea and vomiting (“The device 10 described above in all its various embodiments and variants may be applied to a multitude of ear care or therapeutic tasks. For example, the device 10 may be used for earwax irrigation, to deliver treatment fluids 12 to the patient's external ear canal 26 for a therapeutic benefit or to cleanse the external ear canal 26, or to deliver treatment fluids 12 to the middle ear through a tympanostomy or ear drum perforation such as in the case of a middle ear infection (otitis media) or to dispense ear pain relieving fluid solutions (as in the case of external ear canal inflammation as well as in a middle ear infection).”, [0113]).
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Vlodaver et al. (U.S. Patent Pub. 20110301572), hereinafter Vlodaver, in further view of Johnson et al. (U.S. Patent Pub. 20090266369), hereinafter Johnson, in further view of Elder et al. (U.S. Patent Pub. 20080319393), hereinafter, Elder.
Regarding claim 3, Vlodaver in view of Johnson teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Vlodaver in view of Johnson does not expressly state wherein the second part further comprises a flexible cover attached to the first part and being configured for encapsulating the piston and the push member in the first position.
Elder teaches a self-powered portable syringe pump (Abstract) wherein the second part (plunger 205) further comprises a flexible cover (pump 100 having cap 105 adapted to receive plunger of a syringe) attached to the first part (“body 115 configured in the form of an adjustable sleeve for holding the barrel of a syringe”, [0018]) and being configured for encapsulating the piston and the push member in the first position (see FIG.4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the second part of Vlodaver in view of Johnson to include a flexible cover attached to the first part and being configured for encapsulating the piston and the push member in the first position. Doing so allows for the syringe to have a self-powered syringe pump, as taught by Elder, (see [0018]).
Regarding claim 4, Vlodaver in view of Johnson in view of Elder teaches the claimed invention as discussed above concerning the rejection of claim 3, and Elder further teaches wherein the flexible cover (pump 100 having cap 105 adapted to receive plunger of a syringe) is further configured for allowing the piston to be displaced to the second position by actuation of the push member and for remaining attached to the first part also in the second position, the flexible cover thereby serving as a handle for subsequent removal of the earplug from the ear canal (“two elastomeric members 110 for operatively coupling the cap 105 to the sleeve 115 to apply an elastic or restorative force between cap 105 and sleeve 115. In other words; if deformed by being moved away from sleeve 115, elastic members 110 will apply a force in the direction of arrow A pulling cap 105 towards sleeve 115.”, [0018]).
Regarding claim 5, Vlodaver in view of Johnson in view of Elder the claimed invention as discussed above concerning the rejection of claim 3, and Vlodaver further discloses wherein the elongated member (tube 32) of the first part further comprises an end cup (attachment mechanism 44, see FIG. 18; see [0079; 0083]) at a distal end thereof. However, Vlodaver in view of Johnson does not expressly state wherein a flexible cover encapsulates the end cup; and wherein the end cup is shaped and configured for retaining the flexible cover attached to the first part.
Elder teaches a self-powered portable syringe pump (Abstract) wherein a flexible cover (pump 100 having cap 105 adapted to receive plunger of a syringe) encapsulates the end cup; and wherein the end cup is shaped and configured for retaining the flexible cover attached to the first part (the Examiner notes FIG. 1 of Elder depicts sleeve 115 “suitable for holding syringe barrels of substantially any size or shape” (see [0040]). With the pump 100 of Elder combined with the device of Vlodaver, the distal end 130 of sleeve 115 in Elder would be encapsulating the mechanism 44 of Vlodaver, with sleeve 115 of Elder being attached to the body of syringe 100 of Vlodaver.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the second part of Vlodaver in view of Johnson to include a flexible cover, wherein a flexible cover encapsulates the end cup; and wherein the end cup is shaped and configured for retaining the flexible cover attached to the first part. Doing so allows for the syringe to have a self-powered syringe pump, as taught by Elder, (see [0018]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 7/10/2026, with respect to the rejection(s) of claims 1, 6, 9, 10, and 14-16 under 35 USC 102 (a)(1) for being anticipated by US 2011/0301572 to Vlodaver et al.; claims 3-5 under 35 USC 103 as being obvious over Vlodaver in view of US 2008/0319393 to Elder ("Elder"); and claims 7, 8, and 11- 13 under 35 USC 103 as being obvious over Vlodaver 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 U.S.C. 103 as being unpatentable over Vlodaver et al. (U.S. Patent Pub. 20110301572), in further view of Johnson et al. (U.S. Patent Pub. 20090266369).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
07/23/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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