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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-10, drawn to an electrode casing system, classified in A61N 1/05.
II. Claims 11-17, drawn to a surgical tool, classified in A61B 17/3468
and A61B 17/7083.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as subcombination and combination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the surgical tool adapted to receive and manipulate a cased electrode system does not require the electrode casing to comprise a removable casing with an integrated parting element. The subcombination has separate utility such as releasably encasing other electrical implantable devices besides an electrode array.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different classification, the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must
include (i) an election of an invention to be examined even though the requirement
may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing
the elected invention.
The election of an invention may be made with or without traverse. To reserve a
right to petition, the election must be made with traverse. If the reply does not distinctly
and specifically point out supposed errors in the restriction requirement, the election
shall be treated as an election without traverse. Traversal must be presented at the time
of election in order to be considered timely. Failure to timely traverse the requirement
will result in the loss of right to petition under 37 CFR 1.144. If claims are added after
the election, applicant must indicate which of these claims are readable upon the
elected invention.
Should applicant traverse on the ground that the inventions are not patentably
distinct, applicant should submit evidence or identify such evidence now of record
showing the inventions to be obvious variants or clearly admit on the record that this is
the case. In either instance, if the examiner finds one of the inventions unpatentable
over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected
invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim
remaining in the application. A request to correct inventorship under 37 CFR 1.48(a)
must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that
identifies each inventor by his or her legal name and by the processing fee required
under 37 CFR 1.17(i).
During a telephone conversation with Cheng Jong on 09/23/2025 a provisional election was made without traverse to prosecute the invention of Invention I, claims 1-10. Affirmation of this election must be made by applicant in replying to this Office action. Claims 11-17 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it contains legal phraseology such as “means”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the linear engagement track, as described in claim 7 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show engagement track 50 as described in the specification on page 26. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Staecker (W.O. Application No. 2010045228 A2), and further in view of Guillaume (E.P. Application No. 3513834 A1).
Regarding independent claim 1, Staecker discloses an electrode casing system (10) adapted to releasably enclose at least a portion of an electrode wire (2) (page 6, lines 3-9 & Fig. 1) configured for implantation into a cochlea (page 5, lines 1-2; page 5, last paragraph), said electrode casing system comprising:
a removable casing (combination of carrier 12 and sheath 14), comprising a generally tubular geometry having a longitudinal profile (see Fig. 1), fabricated from a casing material having sufficient rigidity such that said electrode array temporarily conforms to said longitudinal profile provided by said removable casing when encased therein (page 6, last paragraph); and
said casing further comprising an integrated parting segment (i.e., a coupling intersection as seen in Figs. 4-11) disposed along said longitudinal profile of said casing, said integrated parting segment is configured to separate said casing into an open configuration when cooperating with a separator (page 5, lines 23-27; page 12, last paragraph – page 13, first paragraph).
Examiner is interpreting the ability of the user to manipulate the removal of the sheath from the elongate member (i.e., carrier) in order to release the electrode wire once in the correct position inside the patient’s ear as the system inherently comprising a separator/actuating mechanism that allows the user to control the timing of the release.
However, Staecker does not explicitly disclose that the electrode wire is an electrode array.
Guillaume, in the same field of endeavor, teaches a tool (2) for insertion of a cochlear electrode array (4, 40), that extends distally from lead (10), into the cochlear of a hearing aid user, said system comprising a guiding tube (38) configured to be inserted into the user, wherein a piston configured to displace the cochlear electrode along the guiding tube is slidably arranged in the guiding tube (abstract, pa. 0045, 0047 & Figs. 1C, 3C).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrode wire of Staecker to be an electrode array, as taught by Guillaume, since both are known equivalents in the art that would yield to the same predictable results of stimulating the cochlear.
Regarding claim 2, Staecker/Guillaume combination discloses wherein said longitudinal profile of said removable casing is linear (Staecker, see Fig. 1).
Regarding claim 3, Staecker discloses the removable casing can be made out of a metal, alloy, plastic, polymer, rubber, elastomer, plastomer, ceramic, composite, shape memory material, or any other material (page 10, last paragraph).
However, Staecker does not disclose wherein said removable casing is transparent.
Guillaume, in the same field of endeavor, teaches the guiding tube assembly (38), as shown in Fig. 6A, being transparent in order to show the placement of the components inside (pa. 0073).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the removable casing of Staecker in order to be transparent in order to provide additional visuals to the user of the electrode array placed inside the casing.
Regarding claim 4, Staecker/Guillaume combination discloses wherein said removable casing is configured from a polymeric material (Staecker, page 10, last paragraph).
Regarding claim 5, Staecker/Guillaume combination discloses wherein said integrated parting segment is configured in an open slot configuration, said open slot configuration comprises a predetermined distance between a first slot wall and an opposing second slot wall (see annotated Fig. 7 as a non-limiting example) such that said electrode casing substantially retains said electrode array incased therein (Staecker, page 7, lines 11-15, page 7 last paragraph – page 8 first paragraph, and page 8, lines 12-18 & Figs. 4, 7, and 9).
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Regarding claim 6, Staecker/Guillaume combination discloses wherein said integrated parting segment comprises a first slot wall (i.e., outer surface of the carrier 92) and an opposing second slot wall (i.e., inner surface of the sheath 96) which substantially engage each other along at least one engagement track when constrainedly attached to said electrode array, whereby said removable casing provides a substantially gap-free (see lack of lumen recesses/apertures in Fig. 9) enclosure surrounding the external surface of said electrode array along its major axis (Staecker, page 8, lines 12-18).
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Regarding claim 7, Staecker/Guillaume combination discloses wherein said at least one engagement track is linear (Staecker, see annotated Fig. 9 below).
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Regarding claim 8, Staecker/Guillaume combination discloses wherein said at least one engagement track is non-linear (Staecker, see annotated Fig. 9 below).
Regarding claim 9, Staecker/Guillaume combination discloses wherein said at least one engagement track further comprises a set of complementary interlocking profiles (e.g., tongue and groove coupling mechanism), thereby increasing tensile strength (Staecker, page 7, lines 6-8, bottom-up).
Regarding claim 10, Staecker discloses wherein said removable casing includes said electrode wire being slidingly attached therein (page 12, last paragraph - page 13, first paragraph).
However, Staecker does not explicitly disclose that the electrode wire is an electrode array.
Guillaume, in the same field of endeavor, teaches a tool (2) for insertion of a cochlear electrode array (4, 40), that extends distally from lead (10), into the cochlear of a hearing aid user, said system comprising a guiding tube (38) configured to be inserted into the user, wherein a piston configured to displace the cochlear electrode along the guiding tube is slidably arranged in the guiding tube (abstract, pa. 0045, 0047 & Figs. 1C, 3C).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrode wire of Staecker to be an electrode array, as taught by Guillaume, since both are known equivalents in the art that would yield to the same predictable results of stimulating the cochlear.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANA VERUSKA GUERRERO ROSARIO whose telephone number is (571)272-6976. The examiner can normally be reached Monday - Thursday 7:00 - 4:30 PM EST.
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, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794