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 Invention I, claims 16-23 in the reply filed on 4/2/2026 is acknowledged. The traversal is on the ground(s) that the classification is flawed. This is not found persuasive because there is no requirement that every word from the claims appear verbatim in the classification scheme. Class A61N1 relates to electrotherapy which the claims recite providing current to an electrode contact and A61N1/3606 relates to the outer, middle or inner ear which the claims recite when reciting a cochlea, see e.g. claim 20. Further, as stated in the restriction, the inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process, e.g. sensing parameters of a subject. Applicant has not provided any reasoning for why the implanted assembly could not be used for sensing parameters of a subject. Additionally, applicant questions whether there is a serious examination burden and argues that it would not be a search burden to examine all the claims. MPEP 808.02 states "the examiner, in order to establish reasons for insisting upon restriction, must explain why there would be a serious search and/or examination burden on the examiner if restriction is not required. In order to demonstrate a serious search burden, the examiner must show by appropriate explanation one of the following". As stated in the restriction the inventions
would require a different field of search such as searching different classes/subclasses or
electronic resources, or employing different search queries since the different inventions recite mutually exclusive characteristic such as limiting flow of body fluid vs limiting current spread vs an implantable assembly with a barrier about an electrode contact. Different search queries using different keywords related to the claims would be needed based on the mutually exclusive characteristics. Patents are not required to be cited to show different fields of search, see MPEP 808.02. Further, the prior art applicable to one invention would not likely be applicable to another invention, e.g. WO 2015/034981 discloses an electrode contact with a barrier about it which is pertinent to the implantable assembly of claims 31-37 but is not pertinent to other inventions which recite limiting flow of body fluid or limiting current spread. Additionally, the inventions are likely to raise different issues under 35 U.S.C §112 since the implantable assembly is related to structure that does not require the particulars of the method claims. Furthermore, applicant has not provided evidence or identified such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case.
The requirement is still deemed proper and is therefore made FINAL.
Claims 24-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/2/2026.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0001] recites related application 15/337,025 that has now matured into a patent the paragraph should be updated with the issued patent number. Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 21-22 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 21 recites “wherein: the action of managing the flow of body fluid includes limiting flow of body fluid into and out of a volume solidly bounded everywhere by components of an electrode array, of which the electrode contact is a part, and the tissue of the human.” It is unclear what is applicant is attempting to claim when reciting “a volume solidly bounded everywhere by components of an electrode array…and the tissue of the human”. What is meant by “solidly bounded”? What components of the electrode array are providing a volume being bounded everywhere? Is applicant stating that the entire electrode array or all components of the electrode array and the tissue of the human bound a volume? The specification recites almost verbatim what the claim recites, see para. [0093], and does not provide any further details regarding what is meant by “solidly bounded” or what components of the electrode array provide a volume being bounded everywhere or what volume is being bounded by components of an electrode array and tissue of the human. Clarification is required. Claim 22 directly depends from claim 21 and is also rejected to for the reasons stated above regarding claim 21. As best understood, for the purpose of examination, claims 21-22 have been interpreted to include any volume bound between component(s) of an electrode array and tissue.
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) 16-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2009/0254163 to Gibson (Gibson).
In reference to at least claim 16
Gibson discloses a method, comprising: providing an electrical current (e.g. “As used herein, cochlear implants may deliver electrical stimulation in combination with other types of stimulation, such as acoustic and/or mechanical stimulation”, para. [0030]) to an electrode contact located in a human to stimulate tissue of the human (e.g. “Stimulator unit 120 generates stimulation signals which are applied by electrode contacts 148 to cochlea 140, thereby stimulating auditory nerve 114.”, para. [0038]; “A plurality of spaced-apart stimulation elements 148, such as electrode contacts, are mounted or disposed on or in carrier member 202 between expandable portion 240 and tip 211”, para. [0042]); and managing flow of body fluid located inside the human locally to the electrode contact while the current is provided to the electrode contact (e.g. “This may serve to effectively seal and stabilize (i.e., secure) stimulating lead assembly 118 in cochlea 140”, para. [0052], “Sealing stimulating lead assembly 118 in cochlea 140 may help prevent cochlear fluid, such as perilymph, from leaking out of cochlea.”, para. [0054]).
In reference to at least claim 17
Gibson discloses wherein: the action of managing flow of body fluid includes blocking flow of body fluid into and out of a volume located directly between the contact and the tissue in a direction parallel to the tangent surface of the tissue local to the contact (e.g. 240, Figs. 3A-3B; “Sealing stimulating lead assembly 118 in cochlea 140 may help prevent cochlear fluid, such as perilymph, from leaking out of cochlea.”, para. [0054], blocks flow of perilymph into and out of a volume associated with stimulating assembly unit 118 which includes electrode carrier 202 and stimulation elements 148).
In reference to at least claim 18
Gibson discloses the volume is a variable volume (e.g. 240, Figs. 3A-3B; “Sealing stimulating lead assembly 118 in cochlea 140 may help prevent cochlear fluid, such as perilymph, from leaking out of cochlea.”, para. [0054], blocks flow of perilymph into and out of a volume associated with stimulating assembly unit 118 which is variable based on the size of the cochlea and length of the stimulation assembly unit 118).
In reference to at least claim 19
Gibson discloses wherein: the action of managing body fluid flow is executed via the use of a seal (e.g. expandable portion 240, “This may serve to effectively seal and stabilize (i.e., secure) stimulating lead assembly 118 in cochlea 140”, para. [0052]) between an electrode carrier of the electrode contact and a wall of the tissue (e.g. expandable portion 240 is between a stimulating assembly unit 118 that includes an electrode carrier 202), which seal surrounds the contact (e.g. “This may serve to effectively seal and stabilize (i.e., secure) stimulating lead assembly 118 in cochlea 140”, para. [0052], “Sealing stimulating lead assembly 118 in cochlea 140 may help prevent cochlear fluid, such as perilymph, from leaking out of cochlea.”, para. [0054]).
In reference to at least claim 20
Gibson discloses wherein: the contact is part of an electrode array of a cochlear implant (e.g. stimulating assembly unit 118 which includes electrode carrier 202 and stimulation elements 148 is part of an electrode array of a cochlear implant, Fig. 3A) ; the electrode array is reinforced with an elastic pre-curved stiffener (e.g. “Typically, stimulating lead assembly 118 is pre-curved, held in a substantially straight configuration at least during the initial stages of the implantation procedure, and then permitted to conform to the natural shape of the cochlea during and subsequent to implantation.”, para. [0038], therefore an elastic pre-curved stiffener is present allowing a pre-curved stimulation lead assembly that is held straight during implantation procedure and conforms to the natural shape of the cochlear after implantation); and the elastic pre-curved stiffener urges the electrode array against a wall of the cochlea (e.g. “Typically, stimulating lead assembly 118 is pre-curved, held in a substantially straight configuration at least during the initial stages of the implantation procedure, and then permitted to conform to the natural shape of the cochlea during and subsequent to implantation.”, para. [0038]), thereby compressing a barrier surrounding the electrode contact located on the carrier against a wall of the cochlea (e.g. expandable portion 240 of the stimulating lead assembly 118 which contains electrode elements is compressed against a wall of the cochlea; Fig. 3B) so that the barrier forms a seal between the electrode contact and the ambient environment (e.g. “This may serve to effectively seal and stabilize (i.e., secure) stimulating lead assembly 118 in cochlea 140”, para. [0052], the expandable portion 240 is expanded to abut a wall of the cochlea forming a seal between a volume adjacent an electrode element of the stimulating lead assembly 118 and an ambient environment), thereby managing the flow of body fluid, the wall of the cochlea corresponding to the tissue (e.g. “Sealing stimulating lead assembly 118 in cochlea 140 may help prevent cochlear fluid, such as perilymph, from leaking out of cochlea.”, para. [0054]).
In reference to at least claim 21
Gibson discloses wherein: the action of managing the flow of body fluid includes limiting flow of body fluid into and out of a volume solidly bounded everywhere by components of an electrode array (e.g. Fig. 3B, “As illustrated, expandable portion 240 may expand so that it contacts the bone of cochlea 140 surrounding cochleostomy 122. This may serve to effectively seal and stabilize (i.e., secure) stimulating lead assembly 118 in cochlea 140”, para. [0052], “allowing it to expand to abut the boney wall of cochlea 140 may help secure stimulating lead assembly 118 in cochlea 140.”, para. [0053], an internal volume provided from the disclosed sealing is being interpreted as a volume solidly bounded everywhere by components of the electrode array and tissue) of which the electrode contact is a part (e.g. assembly unit 118 includes electrode carrier 202 and stimulation elements 148) and the tissue of the human (e.g. “This may serve to effectively seal and stabilize (i.e., secure) stimulating lead assembly 118 in cochlea 140”, para. [0052]; “Sealing stimulating lead assembly 118 in cochlea 140 may help prevent cochlear fluid, such as perilymph, from leaking out of cochlea.”, para. [0054]).
In reference to at least claim 22
Gibson discloses wherein: a size of the volume is substantially a function of a compression force on a seal establishing a boundary of the volume (e.g. Fig. 3B, “As illustrated, expandable portion 240 may expand so that it contacts the bone of cochlea 140 surrounding cochleostomy 122. This may serve to effectively seal and stabilize (i.e., secure) stimulating lead assembly 118 in cochlea 140”, para. [0052], “allowing it to expand to abut the boney wall of cochlea 140 may help secure stimulating lead assembly 118 in cochlea 140.”, para. [0053], the expanding provides a compression force on the tissue establishing a boundary of an internal volume), which compression force is a result of a pre-curved feature of the electrode array (e.g. “Typically, stimulating lead assembly 118 is pre-curved, held in a substantially straight configuration at least during the initial stages of the implantation procedure, and then permitted to conform to the natural shape of the cochlea during and subsequent to implantation.”, para. [0038], therefore a pre-curved stimulation lead assembly that is held straight during implantation procedure and conforms to the natural shape of the cochlear after implantation).
In reference to at least claim 23
Gibson discloses wherein: the action of managing flow of body fluid is executed using a squished component of an electrode array (e.g. expandable portion 240 is expanded and squished against the tissue creating a seal, Fig. 3B), which squished component forms a barrier between a volume adjacent the electrode contact and an ambient environment outside the volume (e.g. Fig. 3B, “As illustrated, expandable portion 240 may expand so that it contacts the bone of cochlea 140 surrounding cochleostomy 122. This may serve to effectively seal and stabilize (i.e., secure) stimulating lead assembly 118 in cochlea 140”, para. [0052], “allowing it to expand to abut the boney wall of cochlea 140 may help secure stimulating lead assembly 118 in cochlea 140.”, para. [0053], the expandable portion 240 is expanded to abut a wall of the cochlea forming a barrier between a volume adjacent an electrode element of the stimulating lead assembly 118 and an ambient environment outside the volume; “Sealing stimulating lead assembly 118 in cochlea 140 may help prevent cochlear fluid, such as perilymph, from leaking out of cochlea.”, para. [0054]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L GHAND whose telephone number is (571)270-5844. The examiner can normally be reached Mon-Fri 7:30AM - 3:30PM ET.
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/JENNIFER L GHAND/Examiner, Art Unit 3796
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