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 Amendments
The Amendment filed 08/17/2022 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 Non-Final Office Action mailed 06/17/2025.
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.
Claim 5 is 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.
Claim 5 recites the limitation “the flexible cover” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 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, 2, 6, 9, 10, and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vlodaver et al. (U.S. Patent Pub. 20110301572), hereinafter Vlodaver.
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]).
Regarding claim 6, Vlodaver discloses 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 9, Vlodaver discloses 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 discloses 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 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]); and
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]).
Regarding claim 16, Vlodaver discloses 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]).
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 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Vlodaver et al. (U.S. Patent Pub. 20110301572), hereinafter Vlodaver, further in view of Elder et al. (U.S. Patent Pub. 20080319393), hereinafter, Elder.
Regarding claim 3, Vlodaver discloses the claimed invention as discussed above concerning the rejection of claim 1, however, Vlodaver 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 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 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 discloses the claimed invention as discussed above concerning the rejection of claim 1, 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 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 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]).
Claims 7-8 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Vlodaver et al. (U.S. Patent Pub. 20110301572), hereinafter Vlodaver.
Regarding claim 7, Vlodaver discloses 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 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 11, Vlodaver discloses 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 discloses 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 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).
Response to Arguments
Applicant's arguments filed 09/16/2025 have been fully considered but they are not persuasive.
In regards to the Applicant’s argument that “Applicant respectfully submits that features of the syringe 100 cannot be validly compared to the claimed earplug, because the syringe 100 is merely an optional unit in the system 10. Vlodaver's earplug device 14 can just as well be used with the ear dropper 104, wherein the syringe 100 becomes void. This makes it even more clear that the juxtaposition of features taken from the earplug device 14 and the separate, optional syringe 100 in Vlodaver is a purely synthetic one; the resulting combination does not correspond to an actual single device.”
This is not persuasive for the following reasons. While the syringe 100 is separable, its cooperation with device 14 meet the structural and functional limitations of the claim. Together they operate a as a single apparatus, and the claims do not exclude assembly devices or systems wherein the device has multiple components.
In regards to the Applicant’s argument that the Examiner made “an incorrect comparison to apples-to-oranges. Specifically, the Examiner seems to compare (1) the internal volume of the syringe 100 together with the lumen 24 in the earplug device 14 disclosed by Vlodaver to (2) the chamber in the elongated member of the first part of the claimed earplug.”
This is not persuasive for the following reasons. Vlodaver teaches that syringe 100 and device 14 are secured and fluidically sealed and mated. Thus, the distal end of syringe 100 will be placed in the canal of the ear and prior to injection into the canal, the fluid will be contained in the chamber.
Conclusion
THIS ACTION IS MADE FINAL. 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 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
1/09/2025
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783