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
Claims 2-7, 13, 16, and 19-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 17, 2026. In response to Applicant’s further election of Set 1 Species ii the Examiner is additionally withdrawing claims 2-7. Claims 2, 6, and 7, which were originally identified as generic, upon further consideration appear specific to Fig. 2, as the expansion device is only present when the self-expanding sealing element is employed, this is not applicable when the elected balloon is used for sealing.
Applicant’s election without traverse of Set 2 Species c in the reply filed on April 17, 2026 is acknowledged. During a telephone call on April 27, 2026 with Stephanie Mansfield Applicant further elected Set 1 Species ii.
Claim Objections
Claims 1, 8-12, 15, 17, and 18 are objected to because of the following informalities: the preambles of the claims should start with “An” or “The” as appropriate. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: claim 1 requires grammar correction where it recites “as catheter tube,” “as injection lumen,” and “as pressure relief lumen.” Appropriate correction is required.
Claim 10 is objected to because of the following informalities: claim 10 recites “the connection device” which lacks antecedent basis. 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, 12, and 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 9, 12, and 14, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 8, 9, 10, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spiggle et al. (US 2019/0209815 A1).
With regards to claim 1, Spiggle et al. teach ear catheter for insertion into the eustachian tube, including a first tube as catheter tube (Fig. 2 member 2) with at least one first lumen as injection lumen (Fig. 2 member 9) for application of a liquid, at least one second lumen as pressure relief lumen (Fig. 2 member 13) for pressure relief, and a self-expandable sealing element (Fig. 2 member 5, [0030]) for the occlusion of the eustachian tube.
With regard to claim 8, balloon 5 is on the distal portion of the tube and is inflated by lumen 6 (Fig. 2).
With regard to claim 9, see [0018], not shown but all lumens have couplings.
With regard to claim 10, see Fig. 2 lumens 9 and 12 extend distally of 5.
With regard to claim 12, see [0018] valves may be provided in the lumens, at least a flap valve would be a one-way valve.
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.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spiggle et al. (US 2019/0209815 A1) as applied to claim 1 above, and further in view of Chan et al. (US 2017/0119414 A1).
With regard to claim 11, Spiggle et al. teach a device substantially as claimed but do not specifically disclose the tip to be atraumatic. However, Chan et al. teach a catheter for insertion in the ear in which the trip is atraumatic to access the eustachian tube ([0046], [0051]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an atraumatic tip in Spiggle et al. as Chan et al. teach this is beneficial for providing atraumatic to access the eustachian tube.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spiggle et al. (US 2019/0209815 A1) as applied to claim 1 above, and further in view of Chan et al. (US 2017/0119414 A1).
With regard to claim 14, Spiggle et al. teach insertion aid in particular for an ear catheter according to claim 1 (see the rejection above) provided with a headpiece, a middle piece and an end piece ([0008] an insertion tool is used which would necessarily have a headpiece, middle piece, and end piece as it has opposing ends on either side of a middle). Spiggle et al. do not disclose the material of the insertion tool. However, Chan et al. teach using a guide tube to insert a balloon catheter into the eustachian tube and using polymeric materials ([0044], [0045] the materials listed are biocompatible). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a biocompatible polymer in Spiggle et al. as Chan et al. teach such is an art effective material for guiding an instrument into the ear and would yield the same predicted result of insertion.
Claim(s) 15, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spiggle et al. (US 2019/0209815 A1) and Chan et al. (US 2017/0119414 A1) as applied to claim 14 above, and further in view of Smith (US 4,985,018).
With regard to claims 15, 17, and 18, Spiggle et al. teach a device substantially as claimed but do not disclose the insertion aid to be divided with a connecting element. However, Smith teaches using a splitable insertion tube with an insertion aid which includes two parts with a headpiece, end piece, and middle piece and connecting elements, this aids in removing the insertion member without pulling the inserted catheter (abstract, Col. 1 lines 35-39, Fig. 1 device 1 divided into members 2 and 3 connecting elements 26 and 2, headpiece in the area of 11 and 12, end piece opposite, middle piece between). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a splitable sheath with an insertion aid in Spiggle et al. as in Smith as this aids in ensuring the inserted catheter remains while the introducer is removed. As combined the introducer sheath is not considered as the insertion aid rather the aid as provided by Smith is considered.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Examiner notes Chan et al. teach using a self-expanding member (exemplary Figs. 16).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783
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