DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A Request for Continued Examination under 37 CFR 1.114 was filed on 12/22/2025 with a request for suspension of action under 37 CFR 1.103(c) for a period of 3 months. The Office action dated 01/27/2026 was prematurely mailed during the suspension period. Therefore, the Office action mailed on 01/27/2026 is hereby VACATED. See Petition Decision dated 04/06/206.
Election/Restrictions
Newly submitted claim 50 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The invention originally claimed was directed to an expandable reservoir (see original claim set filed 02/15/2021, claim 2).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 50 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 47 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The new matter is that “the apparatus of claim 10, wherein the apparatus is a retinal implant.” The original specification does not have support for the apparatus, as a whole, being a retinal implant. Rather, the specification merely discloses that the implantable electrode array component of the apparatus can be a “retinal implant array”. See para [0036] of the specification, reproduced below:
[0036] Stimulating assembly 118 comprises a longitudinally aligned and distally extending array 146 of electrodes 148, disposed along a length thereof. As noted, a stimulator unit generates stimulation signals which are applied by stimulating contacts 148, which, in an exemplary embodiment, are electrodes, to cochlea 140, thereby stimulating auditory nerve 114. In an exemplary embodiment, stimulation contacts can be any type of component that stimulates the cochlea (e.g., mechanical components, such as piezoelectric devices that move or vibrate, thus stimulating the cochlea (e.g., by inducing movement of the fluid in the cochlea), electrodes that apply current to the cochlea, etc.). Embodiments detailed herein will generally be described in terms of an electrode assembly 118 utilizing electrodes as elements 148. It is noted that alternate embodiments can utilize other types of stimulating devices. Any device, system or method of stimulating the cochlea via a device that is located in the cochlea can be utilized in at least some embodiments. In this regard, any implantable array that stimulates tissue, such as a retinal implant array, or a spinal array, or a pace maker array, etc., is encompassed within the teachings herein unless otherwise noted. (Emphasis added)
As evident in the disclosure reproduced above, the specification only describes a “retinal implant array” being used in a “system or method of stimulating the cochlea via a device that is located in the cochlea”, and does not contain sufficient disclosure that the apparatus of claim 10 (comprising the substance reservoir, electrode array and silicone carrier body) is a “retinal implant”.
Examiner also notes that while claim 50 has been withdrawn and thus not considered for examination, no mention is made in the specification of a reservoir with a fixed volume (the volume of the reservoir is only discussed as being expandable; see specification at paras [0045], [0052], [0053], [0054], [0061], [0062]).
Claim 47 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
As noted above, the specification only describes a “retinal implant array” being used in a “system or method of stimulating the cochlea via a device that is located in the cochlea”, and does not contain sufficient disclosure that the apparatus of claim 10 (comprising the substance reservoir, electrode array and silicone carrier body) is a “retinal implant”. Moreover, the specification fails to provide any explanation or guidance to a person of ordinary skill in the art about how to use the claimed system or method, disclosed only to be used for stimulating the cochlea (via a device that is located in the cochlea), as a retinal implant.
Examiner also notes that while claim 50 has been withdrawn and thus not considered for examination, the specification makes no mention of how therapeutic substance could be delivered from a therapeutic reservoir having a fixed volume.
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 44 and 46 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 44 recites “the therapeutic substance elutor is a backstrap of a cochlear electrode array”. This limitation is not clear because claim 18 (upon which claim 44 depends) recites an “implantable electrode array”. It is not clear whether the “cochlear electrode array” in claim 44 is intended to refer back to the “implantable electrode array” in claim 18. Additionally, the meaning of “backstrap” in this context is not clear.
Regarding claim 46, the limitation “the grommet and the conduit apparatus enable pressurized refilling of the reservoir from the outer ear to repressurize the therapeutic substance reservoir” does not clearly set forth the metes and bounds of the protection sought by applicant. The apparatus of claim 42 (upon which claim 46 depends) does not recite a pressurized therapeutic substance reservoir at all, much less that it is pressurized prior to refilling (claim 42 only recites, inter alia, a “reservoir”). Therefore, it is not clear whether or not claim 46 implicitly limits the apparatus to comprise a pressurized reservoir, or merely a reservoir that is capable of being pressurized during the refilling process.
Further, regarding claim 46, the meaning of “pressurized refilling” is unclear. It is not clear what is, in fact “pressurized” in the context of “pressurized refilling” (e.g., the refilling media is pressurized before refilling the reservoir, the refilling occurs by applying pressure to the refilling media, etc.).
For the purpose of examination, claim 46 will be interpreted to mean that the grommet and the conduit apparatus enable refilling of the reservoir from the outer ear and pressurization of the therapeutic substance reservoir.
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.
Claims 18, 19, 24, 25, 49 and 52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parker (U.S. Pub. 2010/0030130 A1, hereinafter “Parker”).
Regarding claim 18, Parker discloses an apparatus, comprising:
an implantable therapeutic substance reservoir 678 (see Fig. 6);
an implantable electrode array including a plurality of electrodes 630 (see Fig. 6; the electrodes are configured as an array); and
a therapeutic substance elutor (such an array of channels 622 and ports 620; see Fig. 6) as in fluid communication with the therapeutic substance reservoir, which therapeutic substance elutor is attached to the electrode array (as shown in Fig. 6), wherein the implantable therapeutic substance reservoir is part of an assembly 646 that also includes the electrode array (see Fig. 6).
Regarding claim 19, Parker discloses that the assembly is an electrode array assembly 646 (see Fig. 6); and the implantable therapeutic substance reservoir is carried by the electrode array (as shown in Fig. 6).
Regarding claim 24, Parker discloses that the therapeutic substance elutor is attached to the electrode array over most of the length of the electrode array (even though Fig. 6 is a partial view, the elutor appears to be present over most or all of the electrodes in the electrode array).
Regarding claim 25, Parker discloses that the electrode array and the therapeutic substance reservoir are part of a single unit 444 (see Figs. 4-6).
Regarding claim 49, Parker discloses that the electrode array is an electrode array of a cochlear implant (see para [0010]).
Regarding claim 52, Parker discloses that the electrode array is straight (see para [0083], disclosing the electrode assembly being held straight by a stiffening stylet prior to implantation).
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.
Claims 1, 3, 5, 6, 7, 41, 43-45 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Parker in view of Arenberg (U.S. Pat. 5,476,446, hereinafter “Arenberg”).
Regarding claims 1 and 51, Parker discloses an apparatus, comprising:
a cochlear implant electrode array 146 (see Fig. 1); and
an implantable therapeutic substance reservoir (part or all of a pharmaceutical agent source 478 positioned outside of the cochlear region 512, as shown in Fig. 5; alternatively or additionally, para [0096] discloses an “additional reservoir” positioned outside of the cochlea, which is used to hold a therapeutic substance for delivery of the substance to delivery ports 420/620 in the cochlear region), wherein the apparatus is configured such that the therapeutic substance reservoir is in fluid communication with the electrode array (via a catheter or a tube, e.g., 484, which connects the reservoir 478 with delivery ports 420/620; see Fig. 5).
It is noted that Parker discloses that the therapeutic substance reservoir can be located “outside of the cochlea” (see Parker at para [0096]), but Parker does not explicitly disclose that the therapeutic substance reservoir is at least substantially located in a middle ear space when the cochlear implant electrode array is fully implanted in a recipient, and, as per claim 51, the reservoir is located in its totality in a middle ear space when the implant is implanted.
Arenberg discloses an apparatus in the analogous art to Applicant’s invention, comprising a therapeutic substance reservoir, e.g., 220 (see Fig. 11) totally located in a middle ear space 302 (see Fig. 11). Arenberg teaches an embodiment where the reservoir 220 delivers the substance to the inner ear 303 (see, e.g., col. 27, lines 43-50).
A skilled artisan would have found it obvious at the time of the invention to modify the apparatus of Parker to position the therapeutic substance reservoir substantially, or as per claim 51, in its totality, in the middle ear space when the cochlear implant electrode array is fully implanted in a recipient, since Parker does not appear to limit the placement of the therapeutic substance reservoir to any specific location (as noted above, Parker teaches that the reservoir can be located either inside the cochlea or external to the cochlea), and the middle ear was a known placement for a therapeutic substance reservoir for an apparatus delivering substance to the inner ear (based on the teaching in Arenberg) and placing the reservoir immediately adjacent to the inner ear would have usefully obviated the need for a separate elongate catheter or other long tube between the reservoir and the electrode array.
Regarding claim 3, Parker discloses that the electrode array is configured such that the therapeutic substance elutes from the array upon entering the array into the cochlea (via delivery ports 420; see Fig. 5 and para [0080]).
Regarding claim 5, Parker discloses that the apparatus is configured to enable refilling of the reservoir without explanting the reservoir (e.g., by the use of a refilling port or element; see paras [0088]; additionally, there does not appear to be any part of the apparatus of Parker that would preclude refilling the reservoir without explanting it).
Regarding claim 6, Parker discloses a valve, wherein the valve controls flow of the therapeutic substance from the reservoir into the electrode array (see valves 816 in Fig. 8).
Regarding claim 7, Parker discloses that the apparatus comprises a flow restrictor (see one of valves 816 in Fig. 8) that restricts flow out of the reservoir into the electrode array beyond that which would be the case in the absence of the flow restrictor.
Regarding claim 41, Parker discloses that the electrode array has a passageway (e.g., reservoir 678; see Fig. 6) therethrough extending along most of the electrode array (the passageway extends along the ports, which themselves extend along most of the electrode array);
the reservoir is in fluid communication with the passageway (part or all of a pharmaceutical agent source 478 is positioned outside of the cochlear region 512 which communicates to the reservoir 678; para [0096] also discloses an “additional reservoir” positioned outside of the cochlea, which is used to hold a therapeutic substance for delivery of the substance to delivery ports 420/620 in the cochlear region, and so the fluid travels to the ports 620 via the reservoir 678); and
the therapeutic substance flows from the reservoir to the passageway (i.e., the “additional reservoir” positioned outside of the cochlea, which is used to hold a therapeutic substance for delivery of the substance to delivery ports 420/620 in the cochlear region, and so the fluid travels to the ports 620 via the reservoir 678).
Regarding claim 43, Parker discloses that the electrode array is a cochlear implant electrode array (see Fig. 1 showing the electrode array 146 inserted into the cochlea 140); the limitation “the passageway is a lumen for a stylet of a cochlear implant curved electrode array” recites intended use of the passageway that does not impart a structure to the passageway.
Regarding claim 44, the limitation “the therapeutic substance elutor is a backstrap of a cochlear electrode array” has been interpreted to mean that the therapeutic substance elutor is part of a cochlear electrode array; Parker shows that the electrode array 146 inserted into the cochlea 140 and the substance is in fluid communication with the electrode array.
Regarding claim 45, Parker discloses that the cochlear implant electrode array and the therapeutic substance reservoir are “part of a single unit” (i.e., the “single unit” is the apparatus itself, which comprises the cochlear implant electrode array and the therapeutic substance reservoir as previously recited in claim 1).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Parker in view of Arenberg, further in view of Arenberg (U.S. Pub. 2004/0172005 A1, hereinafter “Arenberg”).
Regarding claim 2, Parker discloses that the reservoir is an enclosure that expands upon the insertion of a liquid therapeutic substance therein, which expansion maintains the liquid therapeutic substance under pressure, and forces the therapeutic substance out of the reservoir and into the electrode array over time (see Fig. 8 and para [0103], disclosing a type of the pharmaceutical agent source that comprises a chamber 810 having flexible walls that, together with an actuator, force the pharmaceutical substance out of a valve 8216A and toward the delivery ports).
However, it is noted that Parker, in view of Arenberg, does not explicitly disclose that this enclosure is “elastomeric”.
Arenberg discloses a device and method for delivering small doses of agent to the ear, in the analogous art to Applicant’s invention, comprising a reservoir enclosure made from elastomeric material (see paras [0056]-[0058], [0060]).
A skilled artisan would have found it obvious at the time of the invention to modify the apparatus of Parker, in view of Arenberg, so that the enclosure is one or more of the elastomeric materials disclosed in Arenberg, since the elastomers disclosed in Arenberg would have been usefully biocompatible, drug impermeable and non-reactive with the active agent (see Arenberg at para [0057]).
Claims 10, 12, 13, 14, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Parker in view of Greenberg et al (U.S. Pat. 8,874,239 B2, hereinafter “Greenberg”).
Regarding claim 10, Parker discloses an apparatus, comprising:
an implantable therapeutic substance reservoir (part or all of a pharmaceutical agent source 478 positioned outside of the cochlear region 512, as shown in Fig. 5; alternatively or additionally, para [0096] discloses an “additional reservoir” positioned outside of the cochlea, which is used to hold a therapeutic substance for delivery of the substance to delivery ports 420/620 in the cochlear region); and
an implantable electrode array 146 (see Fig. 1) including a plurality of electrodes 430 (see Fig. 5).
It is noted that Parker does discloses a carrier body (such as the structure that carries the electrodes 430), wherein the therapeutic substance reservoir is in fluid communication with the carrier body (such as via a catheter or tube 484), the carrier body enabling the therapeutic substance to elute through the carrier body (using delivery ports 420 in between the electrodes), but Parker does not appear to disclose that the carrier body is a silicone carrier body.
Greenberg teaches that electrodes used in modern cochlear prostheses are generally held together with their operational wires in a smooth elongated silicone carrier (see col. 1, lines 54-60).
A skilled artisan would have found it obvious at the time of the invention to modify the apparatus of Parker so that the carrier is made of silicone, based at least on the teaching in Greenberg that this material was “typical” for holding electrodes and their associated wires within cochlear protheses known at the time of the invention. A skilled artisan would have had a reasonable expectation of success in modifying the carrier in Parker to be made of silicone, because it was known to be compliant (see Greenberg at col. 6, lines 12-13) and moldable (see Greenberg at col. 6, lines 22-23), both properties suitable for forming a soft, flexible and shapeable cochlear implant.
Regarding claim 12, Parker discloses that the electrode array is a curved electrode array (see Fig. 1 showing the electrode array 146 curved along the shape of the cochlea; see also para [0083]); the following limitation appears to constitute intended use: “the curvature of the electrode array increases the amount of therapeutic substance eluted from the electrode array relative to that which would be the case if the electrode array was straight, all other things being equal.” In this case, Parker shows the channels 622 and ports 620 that would appear to increase in size due to the curvature of the electrode array along the cochlea.
Regarding claim 13, Parker discloses that the apparatus is configured such that the reservoir at least one of periodically loads the silicone carrier body with therapeutic substance or maintains the silicone carrier body loaded with therapeutic substance (see paras [0089]-[0091]; a pump can pump agent from the reservoir, and an electronic module can control the flow rate of the pump, which is interpreted to include periodic or constant loading of the therapeutic substance into the silicone carrier body).
Regarding claim 14, Parker discloses that the electrode array has a passageway (e.g., reservoir 678; see Fig. 6) therethrough extending along at least a substantial portion of the electrode array;
the reservoir is in fluid communication with the passageway (part or all of a pharmaceutical agent source 478 is positioned outside of the cochlear region 512 which communicates to the reservoir 678; para [0096] also discloses an “additional reservoir” positioned outside of the cochlea, which is used to hold a therapeutic substance for delivery of the substance to delivery ports 420/620 in the cochlear region, and so the fluid travels to the ports 620 via the reservoir 678); and the therapeutic substance flows from the reservoir to the passageway, and from the passageway, the therapeutic substance enters the silicone carrier body and then elutes therefrom (i.e., the “additional reservoir” positioned outside of the cochlea, which is used to hold a therapeutic substance for delivery of the substance to delivery ports 420/620 in the cochlear region, and so the fluid travels to the ports 620 via the reservoir 678).
Regarding claim 47, the limitation “the apparatus is a retinal implant” does not appear to impart structure to the apparatus, and is recited in terms of function or intended use of the apparatus. It has been held that claims containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). In this case, the prior art combination is the same as the claimed invention, and so the manner that the claimed apparatus is intended to be employed (such as in the context of the retina) does not differentiate the claimed apparatus from the prior art.
Even so, Parker discloses that its device is not limited to use with an auditory system, but may also be used to treat other conditions such as visual impairment by delivering agents to the retina (see paras [0125]-[0126]).
Claims 42 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Parker, in view of Arenberg, further in view of Jolly et al (U.S. Pub. 2013/0245569 A1, hereinafter “Jolly”).
Regarding claim 42, Parker discloses a conduit apparatus which enables refilling of the reservoir from the outer ear (the portion of the inner and extracochlear regions of the stimulating assembly that deliver fluid from the pharmaceutical agent source 478; see Fig. 5), but does not appear to disclose the conduit apparatus comprises a tympanic membrane grommet, the conduit apparatus extending from the grommet to the therapeutic substance reservoir, such that the grommet also enables refilling of the reservoir from the outer ear, and, in particular regarding claim 46, pressurized refilling of the reservoir from the outer ear to repressurize the therapeutic substance reservoir.
Jolly discloses an apparatus for delivering medication into the inner ear, comprising a tympanic membrane grommet 604 (see Fig. 6) permitting fluid or other instruments to be introduced into a passage 603 (see Fig. 6) of the apparatus. A skilled artisan would recognize that the grommet would enable “pressurized refilling of the reservoir from the outer ear to repressurize the therapeutic substance reservoir” (interpreted to mean that the grommet enables refilling of the reservoir from the outer ear and pressurization of the therapeutic substance reservoir), since Jolly does not appear to prevent any pressurized fluid from entering therethrough.
A skilled artisan would have found it obvious at the time of the invention to modify the apparatus of Parker, in view of Arenberg, to provide a tympanic membrane grommet, the conduit apparatus extending from the grommet to the therapeutic substance reservoir, such that the grommet also enables refilling of the reservoir from the outer ear, as a well-known means for maintaining open access across the tympanic membrane while enabling the introduction of fluid or other components without damaging the tympanic membrane, with a reasonable expectation of success. A skilled artisan would have found that the grommet and the conduit apparatus would enable “pressurized refilling of the reservoir from the outer ear to repressurize the therapeutic substance reservoir” particularly in light of Parker teaching that the implantable therapeutic substance reservoir 478 can include a pressurized reservoir (see Parker at para [0090]).
Response to Arguments
No arguments were filed with the RCE.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 05/29/2026
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