DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 07/06/2026.
In view of the appeal brief filed on 07/06/2026, PROSECUTION IS HEREBY REOPENED. New grounds of rejections are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
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 .
Status of Claims
Claim(s) 1, 9-18, 21-22, 31-37, and 39-45 is/are pending in the application.
Claim(s) 1 was/were withdrawn from consideration.
Claim(s) 9-18, 21-22, 31-37, and 39-45 is/are examined on the merits.
Response to Arguments
Applicant’s arguments filed on 07/06/2026 have been fully considered. However, upon further consideration, a new ground(s) of rejection is made in view of Sacherman (US PGPUB 20190321611). Therefore, the rejection has been withdrawn.
With respect to the claim rejection(s) under 35 U.S.C § 101, Applicant’s argument(s) is/are found persuasive. Therefore, the claim rejection(s) under 35 U.S.C § 101 is/are withdrawn.
With respect to the claim rejection(s) under 35 U.S.C. § 112(b) of claim 39, Applicant’s argument(s) is/are found persuasive. Therefore, the claim rejection(s) under 35 U.S.C. § 112(b) of claim 39 is/are withdrawn.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
In claim 12, lines 4-6, the limitation “a flexible component between the tympanic membrane and the reservoir that enables the tympanic membrane to move a greater amount than that which would be the case if the component was not flexible” has been interpreted under 112(f) as a means plus function limitation because of the generic placeholder “component” and associated functional language “enables the tympanic membrane to move a greater amount than that which would be the case if the component was not flexible” without reciting sufficient structure to achieve the function. Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification (flexible component 381 can be a flexible hose or a tube that extends from the grommet to a manifold or a rigid coupling 2233 that places the tube/flexible hose 381 into fluid communication with the reservoir 920: ¶0128 and Fig. 23) as performing the claimed function, and equivalents thereof.
In claim 16, lines 2-3, the limitation “a means for refillably storing a therapeutic substance; and a means for delivering a therapeutic substance to a cochlea” has been interpreted under 112(f) as a mean plus function limitation because of the combination of a non-structural term “means” and functional language “for refillably storing a therapeutic substance” and “for delivering a therapeutic substance to a cochlea” without reciting sufficient structure to achieve the function. Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification (The reservoir 202 is, prior to or after implantation, at least partially filled with a treatment substance for delivery to the inner ear 107 of the recipient: ¶0046) as performing the claimed function, and equivalents thereof.
In claim 18, lines 2-4, the limitation “the apparatus is configured such that the means for delivering the therapeutic substance interfaces with a stapes footplate of the recipient when the apparatus is operationally implanted in the recipient” has been interpreted under 112(f) as a mean plus function limitation because of the combination of a non-structural term “means” and functional language “for delivering the therapeutic substance interfaces with a stapes footplate of the recipient when the apparatus is operationally implanted in the recipient” without reciting sufficient structure to achieve the function. Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification (The reservoir 202 is, prior to or after implantation, at least partially filled with a treatment substance for delivery to the inner ear 107 of the recipient: ¶0046) as performing the claimed function, and equivalents thereof.
In claim 21, lines 3-4, the limitation “the apparatus includes a means for enabling the tympanic membrane to move a greater amount than that which would be the case in the absence of the means for enabling” has been interpreted under 112(f) as a mean plus function limitation because of the combination of a non-structural term “means” and functional language “for enabling the tympanic membrane to move a greater amount than that which would be the case in the absence of the means for enabling” without reciting sufficient structure to achieve the function. Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification (flexible component 381 can be a flexible hose or a tube that extends from the grommet to a manifold or a rigid coupling 2233 that places the tube/flexible hose 381 into fluid communication with the reservoir 920: ¶0128 and Fig. 23) as performing the claimed function, and equivalents thereof.
In claim 22, lines 2-3, the limitation “the means for storing” has been interpreted under 112(f) as a mean plus function limitation because of the combination of a non-structural term “means” and functional language “for storing” without reciting sufficient structure to achieve the function. Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification (The reservoir 202 is, prior to or after implantation, at least partially filled with a treatment substance for delivery to the inner ear 107 of the recipient: ¶0046) as performing the claimed function, and equivalents thereof.
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 14-15 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 14 recites the limitations “the device is configured such that the silicone body and/or polymer membrane and/or expanded PTFE body is in direct contact with a window of a cochlea and/or an anatomical structure attached to the window … expanded PTFE body to the window” which is indefinite. It is unclear if the claimed “window” is referred to “window of a cochlea” of claim 14 or “round window niche” of claim 9. The limitation has been examined below as if it read -- the device is configured such that the silicone body and/or polymer membrane and/or expanded PTFE body is in direct contact with a window of a cochlea and/or an anatomical structure attached to the round window niche … expanded PTFE body to the round window niche --.
Claim 15 recites the limitations “a refill system based on a middle ear pressure equalization tube” which is indefinite. First, the specification does not provide any insight of a structure of the claimed refill system. Second, is the claimed “middle ear pressure equalization tube” a part of the claimed apparatus? The claim should define the claimed element in terms of its structural characteristics, rather than merely reciting its functions or intended use. In claim 15, Applicant does not provide any structure of the claimed refill system. In the Appeal Brief filed on 07/06/2026, Applicant still does not provide any structure or at least explain what “refill system based on a middle ear pressure equalization tube” is. Applicant provided a NPL document filed on 07/06/2026, titled “Pressure Equalizing Tube Insertion”, saying that “ears tubes are known …. pressure equalizing tubes. They are tiny hollow tubes made of a soft material”. For the purposes of examination, the relevant claim limitation is interpreted as a refill system comprising hollow structure made of a soft/flexible material.
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 9-14, 16-17, 22, 31-37, 39-40, and 42-45 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sacherman (US PGPUB 20190321611).
Regarding claim 9, Sacherman discloses a refillable therapeutic substance delivery device (“a drug delivery device 100 configured to deliver one or more therapeutic agents to one or more regions of the ear from a reservoir”: ¶0068; and “The device may further include an access port into the reservoir and a resealable penetrable barrier positioned within the access port that is configured to be penetrated for refilling of the reservoir with therapeutic agent”: ¶0014 and 0065; thus, the device 100 is a refillable therapeutic substance delivery device) securable to a round window niche of a recipient (an implanted portion or an intracochlear portion 105 of the device 100 has a shape and size configured to provide a snug fit or conforming fit within a round window niche 25: ¶0064, 0071, 0077, and see annotated Fig. 2 below; thus the device 100 is securable to a round window niche 25 of a recipient).
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Regarding claim 10, Sacherman further discloses the therapeutic substance delivery device is refillable while the therapeutic substance delivery device is secured to the round window niche (“the device 100 can be refilled with fresh drug periodically during its lifetime without being removed from the patient”: ¶0097; ¶0072 and 0095).
Regarding claim 11, Sacherman further discloses the apparatus is configured for implantation into a middle ear of a recipient (“the device can include a body 101 having a distal end region and a proximal end region, the body 101 configured to be implanted in a cavity of a middle ear of the patient”: ¶0084; ¶0013 and 0067) and to always be in contact with a tympanic membrane of the recipient other than a permanent explantation of the apparatus (a cannula 120 of the device 100 extended from a reservoir 115 positioned within the ear canal 40 through a tympanic membrane 5: ¶0088; Figs. 2; as shown in Figs. 4 and 6A-B, portion 120 of the device 100 is in contact with and passes within the tympanic membrane 5 for the life of the device 100).
Regarding claim 12, Sacherman further discloses the device includes a reservoir (a reservoir 115: ¶0069 and Figs. 2-4); the device is configured for contact with a tympanic membrane of the recipient (a cannula 120 of the device 100 extended from a reservoir 115 positioned within the ear canal 40 through a tympanic membrane 5: ¶0088; Figs. 2; as shown in Figs.6A-B, portion 120 of the device 100 is in contact with and passes within the tympanic membrane 5 for the life of the device 100); and the device includes a flexible component between the tympanic membrane and the reservoir that enables the tympanic membrane to move a greater amount than that which would be the case if the component was not flexible (a flexible component 120 is between the tympanic membrane 5 and the reservoir 115: ¶0069 and Fig. 2; since the structure recited in the reference Sacherman is substantially identical to that of the claim, claimed properties or functions are presumed to be inherent (MPEP § 2112.01 (I); thus, the flexible component of Sacherman is capable of enabling the tympanic membrane to move a greater amount than that which would be the case if the component was not flexible).
Regarding claim 13, Sacherman further discloses the device extends from contact with a tympanic membrane (5) of the recipient to contact at least with an outer wall of a cochlea of the recipient with a reservoir (115) in between (¶0064, 0071, and Fig. 4); and the reservoir is configured to expand and contract with varying volumes of therapeutic substance therein without placing any effective pressure on the membrane and the window due to the expansion and contraction (¶0093).
Regarding claim 14, Sacherman further discloses:
the device includes a reservoir (a reservoir 115: ¶0069 and Figs. 2-4);
the device includes a silicone body and/or polymer membrane and/or expanded PTFE body in fluid communication with the reservoir (a support ring 107 is formed from silicone or PTFE and the support ring is in fluid communication with the reservoir 115: ¶0075, 0081, and Figs. 2-4; thus, the device 100 includes a silicone body 107 in fluid communication with the reservoir 115); and
the device is configured such that the silicone body and/or polymer membrane and/or expanded PTFE body is in direct contact with a window of a cochlea and/or an anatomical structure attached to the round window niche (the device is configured such that the silicone body 107 is in direct contact with a round window membrane 27 attached to the round window niche 25: ¶0019, 0064, and Fig. 5) when the device is implanted in a recipient (¶0019 and Fig. 5) so that therapeutic substance in the reservoir can travel through the silicone body and/or polymer membrane and/or expanded PTFE body to the round window niche (¶0075 and Fig. 5).
Regarding claim 16, Sacherman discloses an apparatus (a drug delivery device 100: Abstract, ¶0068, and Figs. 2-4) comprising a means for refillably storing a therapeutic substance (“a reservoir 115 for containing a source of therapeutic agent 133”: ¶0069 and “the reservoir 115 can be refilled such as via a proximal cannula 120”: ¶0085 or “the reservoir 115 can be refilled as described elsewhere herein”: ¶0093; thus, the reservoir 115 reads on the claimed means for refillably storing a therapeutic substance 133; and a means for delivering a therapeutic substance to a cochlea (a drug release element 110 “can be positioned within the cochlea 20 or cochlear space 132 such that the one or more therapeutics 133 contained within the reservoir 115 can be delivered over time directly into the fluid of the cochlea 20 or the cochlear space 13”: ¶0070 or “The drug release element 110 can be positioned such that it is in fluid communication with the cochlea 20”: ¶0073 and Figs. 2-4; thus, the drug release element 110 reads on the claimed means for delivering a therapeutic substance to a cochlea).
Regarding claim 17, Sacherman further discloses the apparatus is configured to deliver the therapeutic substance to the cochlea via diffuse osmosis (the device is configured to deliver the therapeutic substance to the inner ear using osmotic pump or infusion pump: ¶0048; “the devices and systems described herein can be used to deliver therapeutic agent(s) for an extended period of time from a body that defines, at least in part, a reservoir to one or more of the following tissues: round window membrane, cochlea, hair cells of the cochlea, and other tissues of the middle and inner ear” (¶0050); since a cochlea is a part of the inner ear and a person having ordinary skill in the art would have understood/recognized an osmotic pump is a device that use osmotic pressure to deliver medication, the device 100 is capable of deliver the therapeutic substance to cochlea using diffuse osmosis).
Regarding claim 22, Sacherman further discloses the apparatus is configured to store and deliver a plurality of therapeutic substances in between initial implantation and a first replenishment of the means for storing and/or in between a first replenishment and a second replenishment (¶0014 and 0095).
Regarding claim 31, Sacherman further discloses the refillable therapeutic substance delivery device includes a reservoir (a reservoir 115: ¶0069 and Figs. 2-4); and the refillable therapeutic substance delivery device includes a substance transfer component configured to transfer therapeutic substance to be delivered by the apparatus to the recipient (a proximal cannula 120 extending between a region of the reservoir 115 to a region of the device 100 where the drug release element 110 is positioned and configured to transfer therapeutic substance to be delivered by the apparatus to the recipient: ¶0071, 0079-0080, and Figs. 2-4).
Regarding claim 32, Sacherman further discloses the refillable therapeutic substance delivery device includes a substance transfer component configured to transfer therapeutic substance to be delivered by the apparatus to the recipient (a proximal cannula 120 extending between a region of the reservoir 115 to a region of the device 100 where the drug release element 110 is positioned and configured to transfer therapeutic substance to be delivered by the apparatus to the recipient: ¶0071, 0079-0080, and Figs. 2-4), the substance transfer component being in fluid communication with the reservoir (¶0071, 0079-0080, and Figs. 2-4).
Regarding claim 33, Sacherman further discloses the entire apparatus is configured to be totally implanted within a middle ear cavity of the recipient (“The device includes a body having a distal end region and a proximal end region. The body is configured to be implanted in a cavity of a middle ear of the patient”: ¶0013).
Regarding claim 34, Sacherman further discloses the apparatus includes a refilling component configured to enable refilling of the therapeutic substance delivery device (one or more penetrable refill or access ports 125 configured to enable refilling of the therapeutic substance delivery device: ¶0095 and Figs. 2-3); and the apparatus is configured to be implanted within a middle ear cavity of the recipient with only the refilling component being outside, at least in part, of the middle ear cavity (“The device includes a body having a distal end region and a proximal end region. The body is configured to be implanted in a cavity of a middle ear of the patient”: ¶0013 and “The access port 125 can be configured to be penetrated from outside the inner ear for substantially non-invasive filling, flushing, and/or refilling of the reservoir 115”: ¶0095; thus, the device 100 is configured to be implanted within a middle ear cavity of the recipient with only the refilling component being outside, at least in part, of the middle ear cavity).
Regarding claim 35, Sacherman further discloses the refillable therapeutic substance delivery device is configured to be in direct contact with a round window of the recipient when the therapeutic substance delivery device is secured to the round window niche (the device is configured is in direct contact with a round window membrane 27 via a support ring 107 when the device is secured to the round window niche 25: ¶0019, 0064, and Fig. 5).
Regarding claim 36, Sacherman further discloses the apparatus is an implantable apparatus configured for implantation into a human recipient (Abstract, ¶0007, and Claim 1).
Regarding claim 37, Sacherman further discloses the refillable therapeutic substance delivery device is configured to deliver therapeutic substance to a round window of the recipient without the refillable therapeutic substance delivery device directly contacting the round window of the recipient (“The devices and systems described herein can be used to deliver therapeutic agent(s) for an extended period of time from a body that defines, at least in part, a reservoir to one or more of the following tissues: round window membrane, cochlea, hair cells of the cochlea, and other tissues of the middle and inner ear”: ¶0050; A person having ordinary skill in the art would have understood that a round window is located at the interface between a middle ear and an inner ear; Thus, Sacherman suggests the device 100 is configured to deliver therapeutic substance to a round window of the recipient without the refillable therapeutic substance delivery device directly contacting the round window of the recipient, because the device 100 is secured to the round window niche 25 rather than directly to the round window: see rejection of claim 9 above).
Regarding claim 39, Sacherman further discloses the refillable therapeutic substance delivery device is configured so that it does not include a component that interfaces with a round window of the recipient when the device is implanted in the recipient (since the device 100 is positioned within the round window niche 25: ¶0072 and Fig. 2, the device 100 does not comprise a component that interface with a wound window of the patient when the device 100 is implanted).
Regarding claim 40, Sacherman further discloses the apparatus is an implantable medical device (Abstract, ¶0007, and Claim 1).
Regarding claim 42, Sacherman further discloses:
the means for delivering the therapeutic substance to the cochlea includes a sponge and/or a porous body in fluid communication with the means for storing therapeutic substance (the means for delivering a therapeutic substance to a cochlea 110 comprises a porous outer ring and in fluid communication with the means for storing therapeutic substance 115: ¶0076 and see rejection of claim 16 above); and
the device is configured such that the sponge and/or porous body is in direct contact with a window of a cochlea and/or an anatomical structure attached to the window (a drug release element 110 comprises the porous body “can be positioned within the cochlea 20 or cochlear space 132 such that the one or more therapeutics 133 contained within the reservoir 115 can be delivered over time directly into the fluid of the cochlea 20 or the cochlear space 13”: ¶0070; thus, Sacherman implicitly discloses the porous body is in direct contact with an anatomical structure attached to the window) when the device is implanted in a recipient so that therapeutic substance in the means for storing can travel through the sponge and/or porous body to the window (¶0070-0071, and Figs. 2-4).
Regarding claim 43, Sacherman further discloses the apparatus is configured to extend from attachment to a tympanic membrane to the cochlea (the device 100 is configured to extend from attachment to a tympanic membrane 5 to the cochlea 20: ¶0088, Figs. 2, and 6A-B).
Regarding claim 44, Sacherman further discloses the device is configured such that the silicone body and/or polymer membrane and/or expanded PTFE body is in direct contact with a round window of the cochlea and/or an anatomical structure attached to the round window (the silicone body 107 is in direct contact with the round window membrane 27: ¶0019 and Fig. 5; and a person having ordinary skill in the art would have understood that the round window membrane covers/spans the round window of the cochlea; therefore, the round window membrane reads on the “anatomical structure attached to the round window”) when the device is implanted in the recipient (¶0019 and Fig. 5) so that therapeutic substance in the reservoir can travel through the silicone body and/or polymer membrane and/or expanded PTFE body to the round window (¶0075: therapeutic substance in the reservoir can travel through the silicone body 107 to the round window of the cochlea 20).
Regarding claim 45, Sacherman further discloses the refillable therapeutic substance delivery device is configured to be in contact with a tympanic membrane (a cannula 120 of the device 100 extended from a reservoir 115 positioned within the ear canal 40 through a tympanic membrane 5: ¶0088; Figs. 2 and 6A-B; thus, the device 100 is configured to be in contact with a tympanic membrane) of the recipient for at least 3 months (“The devices described herein can remain in position to deliver one or more therapeutic agents to the ear for a period of time … at least 90 days: ¶0097).
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 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.
Claim(s) 41 is/are rejected under 35 U.S.C 103 as being unpatentable over Sacherman (US PGPUB 20190321611).
Regarding claim 41, Sacherman further discloses the apparatus is configured to at least one fit in a round window niche or adhesively adhere to an outer wall of the cochlea (an intracochlear portion 105 of the device 100 has a shape and size configured to provide a snug fit or conforming fit within a round window niche 25: ¶0064, 0071, 0077, and Fig. 2; thus, the device 100 is configured to at least one of interference fit in a round window niche). Sacherman discloses a conforming fit instead of an interference fit.
However, a person of ordinary skill in the art would have recognized that an interference fit or an adhesive are obvious variants of a conforming fit.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the device of Sacherman by using interference fit in a round window niche or applying adhesive, in order to provide fit between the device and the round window niche or an outer wall of the cochlea, as suggested in ¶0064 of Sacherman.
Allowable Subject Matter
Claim(s) 18 and 21 is 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.
Regarding claim 18, Sacherman fails to disclose the means for delivering the therapeutic substance interfaces with a stapes footplate of the recipient when the apparatus is operationally implanted in the recipient. Examiner did not find any teachings/motivations to modify the device to have the means for delivering the therapeutic substance interfaces with a stapes footplate of the recipient when the apparatus is operationally implanted in the recipient. There is not an apparent/obvious reason/motivation for this modification as this modification increases the complexity of the system in the prior art in terms of structure, function, and design (See MPEP §2143.01 (IV)).
Regarding claim 21, Sacherman further discloses the apparatus is configured for contact with a tympanic membrane of the recipient (a cannula 120 of the device 100 extended from a reservoir 115 positioned within the ear canal 40 through a tympanic membrane 5: ¶0088; Figs. 2; as shown in Figs.6A-B, portion 120 of the device 100 is in contact with and passes within the tympanic membrane 5 for the life of the device 100); Sacherman fails to disclose a means for enabling the tympanic membrane to move a greater amount than that which would be the case in the absence of the means for enabling. Examiner did not find any teachings/motivations to modify the device to incorporate a means enabling the tympanic membrane to move a greater amount than that which would be the case in the absence of the means for enabling. There is not an apparent/obvious reason/motivation for this modification as this modification increases the complexity of the system in the prior art in terms of structure, function, and design (See MPEP §2143.01 (IV)).
No other prior art was located that fairly suggested the claimed invention in whole or in part, along with the requisite motivation for combining to render the claimed invention obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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/NHU Q. TRAN/ Examiner, Art Unit 3781
/ANDREW J MENSH/ Primary Examiner, Art Unit 3781
