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 .
Specification
The disclosure is objected to because of the following informalities:
The specification provides conflicting information regarding the length of the device. The claims call for the device to have a length of less than 5 millimeters, however this limitation is only supported in the background section of the specification – page 1, para. 0003, and appears to conflict with the remainder of the disclosure. In describing the actual invention, the specification recites on page 6, para. 0020 that the length L1 of the implant can be approximately 2.5 cm, or 2 to 3 cm, or less than 3 cm or less than 2 cm, and similar lengths discussed on page 9, para. 0025. Therefore, it appears as though the length of the implant is meant to be roughly 2 to 3 cm as disclosed, not less than 5 mm as claimed. It is not clear that the disclosure supports the claimed dimension, and further the disclosure in the background section is confusing as it does not conform to the bulk of the disclosure.
The specification bottom of page 6 to top of page 7 recites “ Likewise, the width or diameter of surgical implant 100 can be approximately 0.7 cm for most aural implant applications, but with a distribution of lengths ranging from 0.5 to 1 cm depending on the specific dimensions of the patient’s ear canal” [emphasis added]. It appears as thought this should read -a distribution of widths or diameters – as this is the dimension being discussed in this sentence, as opposed to previously discussed lengths. Similar disclosure can be found on page 9 in the middle of paragraph 0025.
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.
Claim 18 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 18 recites, “Performing a method with a device …” and further recites aspects of the device and method steps. It appears as though Applicant is attempting to claim a method, however the claim as written is not clear. “Performing a method…” is itself a method step, and therefore the claim reads as though the act of performing is being claimed rather than a method of performing. The act of performing is not a recognized statutory category. Method claims are typically written in the form – A method of performing ... Appropriate correction is required.
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.
Claim(s) 1-3, 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muni et al (US 2014/0074065).
Regarding claim 1, the limitation “for post-operative ear canal treatment” is interpreted to be an intended use limitation. Muni discloses a device capable of being used for post-operative ear canal treatment. Muni discloses a device comprising a plurality of sides (fig. 7: each wire forms a “side”), each having a length of less than 5 millimeters (see fig. 7 annotated below wherein the “sides” make up less roughly a quarter of the length of the device and the device has a length of 20 mm (page 4, para. 0048) meaning the length of the sides is less than 5mm), the plurality of sides coupled to an adjacent side at a first end and to another adjacent side at a second end (fig. 7 annotated below), the plurality of sides forming a compressible tube (page 2, para. 0015); and a delivery system 900 configured to controllably install the device in a body lumen (page 7, para. 0069; fig. 9). The limitation install in the ear canal with a restriction on the extent to which the delivery system can be inserted into the ear canal, so as to prevent injury to an ear drum is interpreted to be an intended use limitation. The delivery system 900 of Muni is capable of performing this function
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Regarding claim 2, Muni discloses that the delivery system 900 comprises a tube 912 (fig. 9).
Regarding claim 3, Muni discloses that the delivery system comprises a plunger 904 (fig. 9; page 7, para. 0070).
Regarding claim 8, Muni discloses that the plurality of sides are each formed from a material that dissolves over time when exposed to an ear canal and which releases a predetermined ear medication as it dissolves (page 3, para. 0041; page 4, para. 0050).
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) 9, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rasmussen et al (EP 3 148 216 A1) in view of Howard et al (US 8,184,842).
Regarding claim 9, Rasmussen teaches a method of treating an ear. The limitation “post-operative ear canal treatment” is interpreted to be a non-specific limitation wherein the timing of the operation nor the location of the operation is recited. The operation is not positively recited. Therefore, the treatment taught by Rasmussen is interpreted to be a post-operative treatment because the recited steps are not specific to any particular operation. Rasmussen discloses the step of inserting a device having a length onto a delivery system (fig. 1A), inserting the system into an ear canal without contacting an ear drum 18 (fig. 6) and deploying the device into the ear while withdrawing the delivery system (figs. 1, 6).
Claim 9 calls for the device to have a length of less than 5 millimeters. Rasmussen does not specifically disclose the length of the device, but teaches that the length is minimized (page 2, para. 0023), and shows that the device occupies only a small portion of the length of the ear canal (fig. 6). An adult ear canal is typically about 25 mm, and therefore, as illustrated in fig. 6, it appears as though the device of Rasmussen is roughly within the range of about 5 mm. Additionally, Applicant has not provided criticality to the claimed length of 5 mm. As discussed above with regard to the specification objection, the disclosure does not discuss a length of less than 5 mm in any depth. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the device of Rasmussen would be roughly 5mm based on the illustration in fig. 6, and as there is no criticality to the claimed dimension of “less than 5 mm”, the device having a length of less than 5mm is not patentably distinct from Rasmussen.
Claim 9 further calls for the step of inserting the device into a tube; inserting the tube; inserting a plunger into the tube; and deploying the device in the ear canal by pushing the device out of the tube with the plunger. Rasmussen teaches a different type of deployment mechanism. Howard teaches a device for deploying a device into an ear canal including the step of inserting the device into a tube having a plunger (fig. 4), inserting the tube into an ear (fig. 5A), and using the plunger to eject the device out of the tube into the ear (fig. 5B). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the deployment mechanism of Rasmussen to be in the form of a tube having a plunger wherein the tube is inserted into the ear and the device is ejected from the tube using the plunger as taught by Howard to allow for insertion of the device into the ear without damage to the ear canal or to the device.
Regarding claim 17, Rasmussen and Howard teach that the deployment mechanism is only used for insertion of the device into the ear canal and therefore the step of removing the tube from the ear canal after deployment is implied.
Allowable Subject Matter
Claims 4-7, 10-16 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.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter of the claims listed above could not be found and was not suggested by the prior art of record.
Regarding claims 4-7, 10-16 the prior art fails to teach or fairly suggest the delivery system comprising a movable brace disposed on the tube and/or a movable stop disposed on the plunger in combination with the features of the invention, substantially as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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