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 .
Election/Restrictions
Applicant's election with traverse of Species C (Figs. 14A-20D) in the reply filed on June 18, 2026 is acknowledged. The traversal is on the ground(s) that restriction requirement failed to include reasoning as to why a search of all claims would present an undue burden. This is not found persuasive because (a) the restriction requirement identified the differences between the three species, (b) the restriction requirement noted that none of the claims are generic to all species, and (c) the restriction requirement indicated that a search of the different species would require distinct text search queries (see pg. 2). The requirement is still deemed proper and is therefore made FINAL.
Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species (elected Species C includes a capsule as stated in paras. 0079-0081 and 0084, not a reservoir as recited in claim 1; nonelected Species A includes a reservoir as stated in paras. 0048, 0053-0055, 0059, and 0060; nonelected Species B includes a reservoir as stated in paras. 0064, 0065, 0068, and 0075), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on June 18, 2026.
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 15-19 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. Claim 15 recites “wherein a force applied to the rupturable portion displaces fluid through the rupturable portion.” Such a recitation is indefinite as it is inconsistent with the description of the capsule in the specification. The specification recites that the exterior portion is formed from a deformable material and that force applied to the exterior portion causes rupturing of the rupturable portion (see para. 0082). Thus, for examination purposes, the Examiner is interpreting claim 15 as reciting “wherein a force applied to the deformable portion displaces fluid through the rupturable portion.” Claims 16-18 depend from claim 15 and are therefore also rejected. Claim 19 is a method of using the device of claim 15 and is therefore also rejected.
Claims 16-18 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. Claim 16 recites “wherein the gap is divided into at least one fluid channel and at least one other channel.” However, claim 15 already recites that the gap and the channel separator define a fluid channel. Thus, it is unclear whether “at least one fluid channel” in claim 16 is intended to (a) include the fluid channel recited in claim 15 such that there are one or more fluid channels or (b) refer to an additional fluid channel such that there are at least two fluid channels. For examination purposes, the Examiner is interpreting claim 16 as reciting “wherein the fluid channel comprises at least one fluid channel, and wherein the gap is divided into the at least one fluid channel and at least one other channel.” Claims 17 and 18 depend from claim 16 and are therefore also rejected.
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.
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over March et al. (DE 10 2004 039 074 A1) in view of Vlodaver et al. (US 2006/0253087 A1) and Djupesland (US 2004/0112378 A1).
March discloses a device for facilitating the delivery of a fluid into a body cavity, comprising:
a speculum body (see Fig. 1) having a distal region (see Fig. 1 inset) that is generally conical in shape (outer funnel 1.2 and inner funnel 1.1 are both conical as shown in Fig. 1), the body including an exterior wall (outer funnel 1.2), an interior wall (inner funnel 1.1), and at least one channel separator (plastic ring 3, which includes a portion between outer funnel 1.2 and inner funnel 1.1 as shown in Fig. 1) between the exterior wall and interior wall, wherein the interior wall defines a viewing channel (see Fig. 1 inset), wherein the interior and exterior wall are separated by a gap (gap 2), wherein the gap and the channel separator define a fluid channel (see Fig. 1 inset), and wherein the fluid channel is closed at a proximal end (see Fig. 1 inset) and extends to a distal end (see Fig. 1 inset) of the body to form a dispensing aperture (see Fig. 1 inset); and
means for introducing the fluid (pipe socket 4) comprising a dispensing portion (see Fig. 1 inset) disposed between the walls and in fluid communication with the fluid channel (Fig. 1).
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March fails to disclose that the means for introducing the fluid comprises a capsule holding the fluid, wherein the capsule comprises a rupturable portion disposed between the walls and in fluid communication with the fluid channel and a deformable portion extending outward from the exterior wall, wherein a force applied to the deformable portion displaces the fluid through the rupturable portion, along the fluid channel and out from the dispensing aperture.
Vlodaver teaches a device for facilitating the delivery of a fluid into a body cavity, comprising: a body (earplug 14) having an exterior wall (outer surface of earplug 14) and a fluid channel (lumen 24) extending to a dispensing aperture (orifice 34); and a capsule (delivery bulb 16 and valve 64) comprising a dispensing portion (valve 64) in fluid communication with the fluid channel and a deformable portion (delivery bulb 16; see para. 0068, which refers to squeezing or compressing delivery bulb 16) extending outward from the exterior wall, wherein a force applied to the deformable portion displaces the fluid through the dispensing portion, along the fluid channel and out from the dispensing aperture (see para. 0068) (Figs. 1-4).
Djupesland teaches a device for facilitating the delivery of a fluid into a body cavity, comprising: a body (housing 132) having a fluid channel (delivery tube 158) extending to a dispensing aperture (at head 156); and a capsule (chamber 162) comprising a rupturable dispensing portion (rupturable seal 166) in fluid communication with the fluid channel, wherein increased pressure to the fluid causes the rupturable dispensing portion to rupture and displaces the fluid through the rupturable portion, along the fluid channel, and out from the dispensing aperture (see para. 0182) (Figs. 9a-9d).
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 device of March such that the means for introducing the fluid comprises a capsule holding the fluid, wherein the capsule comprises a rupturable portion in fluid communication with the fluid channel and a deformable portion extending outward from the exterior wall, wherein a force applied to the deformable portion displaces the fluid through the rupturable portion, along the fluid channel and out from the dispensing aperture, as suggested by Vlodaver and Djupesland, as such is a simple substitution of one means for introducing the fluid for another. In view of such a modification, the rupturable portion would be disposed between the walls.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over March et al. (DE 10 2004 039 074 A1) in view of Vlodaver et al. (US 2006/0253087 A1), Djupesland (US 2004/0112378 A1), and Raghuprasad (US 2011/0015489 A1).
March, Vlodaver, and Djupesland teach a method of using the device according to claim 15 (see the rejection of claim 15 above for the device of claim 15), comprising the steps of inserting the distal end of the body into a body cavity (see paras. 0001-0002 of March) and applying the force to the deformable portion to deliver the fluid to the tissue through the dispensing aperture (see para. 0002 of March; see para. 0068 of Vlodaver).
March, Vlodaver, and Djupesland fail to teach visualizing tissue within the cavity through the viewing channel.
Raghuprasad teaches a method of using a device, wherein the device comprises a body (speculum 22 and cover 40A) having a fluid channel (passageway 110) and a viewing channel (channel terminating in viewing window 21 as shown in Fig. 12), wherein the method comprises inserting a distal end of the body into a body cavity (see Fig. 12), delivering fluid to the tissue via the fluid channel (see para. 0037), and visualizing tissue within the cavity through the viewing channel via an unobstructed viewing path to enable the doctor to see directly into the patient’s ear canal during the procedure (see para. 0035) (Figs. 2, 7, and 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of March by visualizing tissue within the cavity through the viewing channel, as suggested by Raghuprasad, in order to enable the doctor to see directly into the patient’s ear canal during the procedure.
Allowable Subject Matter
Claims 16-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including (a) all of the limitations of the base claim and any intervening claims and (b) amendments consistent with the Examiner’s interpretations as stated above in order to overcome the 35 U.S.C. 112 rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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