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 .
This is the first office action in response to the above identified patent application filed on 10/03/2023. Claims 1, 5-12, 14-20, 26, 28, 30, 33 and 34 are currently pending and being examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 26 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 26 recites the limitation "the width" in line 3. There is insufficient antecedent basis for this limitation in the claim. Further, this claim improperly depends from canceled claim 25. Appropriate correctio is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5, 6, 15-20, 26, 28, 33 and 34 are rejected under 35 U.S.C. 102a1 as being anticipated by Gibson (US 2009/076581).
In regards to Independent Claim 1, and with particular reference to Figures 1, 2A, 4A, 5A, 5B, 5C, Gibson discloses a method, comprising:
inserting a therapeutic substance delivery device 300 into a body chamber 115 of a recipient;
adhering (once the drug-delivery capsule 300 is discharged into the cochlea 115 via the drug release ports 240, the capsule 300 will remain in the cochlea after releasing the drug/medication, reason for which the capsule is made of a resorbable material that will degrade over time through interaction with body fluids, figures 5A-5C, par. 45, 52; thus the capsule 300 will be fixed/adhered to the walls of the cochlea/implant site for some time until completely degraded) the therapeutic substance delivery device 300 to a surface of the body chamber (whichever surface of the body 115 on which it was discharged via the drug release ports 240); and
delivering, with the therapeutic substance delivery device 300, one or more therapeutic substances (medication contained by the drug-delivery capsule 300; figures 5A-5C, par. 30, 44) to the body chamber.
Regarding dependent Claim 5, Gibson discloses wherein adhering the therapeutic substance delivery device 300 to the surface of the body chamber 115 comprises: adhering the therapeutic substance delivery device 300 to the surface of the body chamber 115 via a wet bond formed between the therapeutic substance delivery device and the surface of the body chamber (the drug release capsule is comprised of a resorbable material that partially or completely degrades over time through interaction with various body fluids “wet bond”; thus the capsule 300 via a wet bond will be fixed/adhered to the walls of the cochlea/implant site for some time until completely degraded; see figures 5A-5C, par. 45, 52).
Regarding dependent Claim 6, Gibson discloses wherein the body chamber is a cochlea canal 115 of the recipient, and wherein adhering the therapeutic substance delivery device 300 to a surface of the body chamber 115 comprises: adhering the therapeutic substance delivery device 300 to a modiolar wall of the cochlea canal (as explained for the rejection of claim 5 above, the capsule 300 via a wet bond will be fixed/adhered to the walls of the cochlea/implant site for some time until completely degraded; see figures 5A-5C, par. 45, 52).
Regarding dependent Claim 15, Gibson discloses wherein the body chamber 115 is located behind a tissue barrier in the recipient, and wherein the method further comprises: forming an opening404 in the tissue barrier of the recipient; inserting the therapeutic substance delivery device 300 into the body chamber 115 behind the tissue barrier via the opening 404; and sealing the opening in the tissue barrier with the therapeutic substance delivery device within the body chamber, as shown in figures 5A-5B.
In regards to Independent Claim 16, and with particular reference to Figures 1, 2A, 4A, 5A, 5B, 5C, Gibson discloses an apparatus, comprising:
a fully bioresorbable substrate (the capsule 300 is made of a resorbable material that will degrade over time through interaction with body fluids, figures 5A-5C, par. 45, 52) configured to be inserted into a body chamber 115 of a recipient to assume a position in close proximity to a first side (implant site where capsule adheres after being discharged into the cochlea 115 via ports 240; refer to figures 5a-5C) of the body chamber 115 without affecting structures of the body chamber on a second side of the body chamber (opposite side to the implant side; no indication that the drug-delivery capsule 300 affects any structures; on the contrary it provides benefits to an implant recipient, par. 23, 45); and
one or more therapeutic substances disposed in or on the substrate (medication contained by the drug-delivery capsule 300; figures 5A-5C, par. 30, 44).
Regarding dependent Claim 17, Gibson discloses wherein the substrate 300 is formed from an adhesive material (Interpretation 1: the capsule 300 is made of a resorbable material that will degrade over time through interaction with body fluids, figures 5A-5C, par. 45, 52; the resorbable material taken as the adhesive material because it adheres to the walls of the cochlea via a wet bond with body fluids; Interpretation 2: the capsule’s outer surface is impregnated with a glue layer that was added to the lumen 224, par. 51, after the capsule is released via ports 240, whatever type of adhesive used that remains on the outer surface of the capsule will adhere to the walls of the cochlea) configured to adhere to a wall at the first side of the body chamber.
Regarding dependent Claim 18, Gibson discloses wherein the adhesive material comprises an adhesive gel (referring to the rejection of claim 17, the adhesive gel is either the wet bond or remains of the liquid adhesive/glue on the capsule’s outer surface, par. 51).
Regarding dependent Claim 19, Gibson discloses wherein the adhesive material is configured to adhere to a wet surface at the first side of the body chamber (referring to the rejection of claim 17, whatever type of adhesive used that remains on the outer surface of the capsule will adhere to the walls of the cochlea, par. 51).
Regarding dependent Claim 20, Gibson discloses wherein the substrate 300 comprises a first surface configured to be positioned adjacent a wall at the first side of the body chamber 115, and wherein the apparatus comprises: an adhesive disposed on the first surface of the substrate (referring to the rejection of claim 16, whatever type of adhesive used that remains on the outer surface of the substrate/capsule will adhere to the walls of the cochlea, par. 51).
Regarding dependent Claim 26, Gibson discloses wherein the width of the substrate 300 is at least twice the thickness of the substrate (as shown in figures 3, 5B, the width “length” of the substrate/capsule 300 is at least twice the thickness “diameter” of the substrate).
Regarding dependent Claim 28, Gibson discloses wherein the substrate has a thickness that is less than approximately 200 microns (as structures in the cochlea 115 are relatively small in cross-sectional size, the lumen opening 404 will be in the scale of microns, the lumen carries the capsules so the capsules will have even a smaller diameter than the lumen in the scale of microns; drug-delivery capsules typically have a small diameter in the scale of microns, typically less than 200 microns, refer to figures 4A, 5A, 5B).
Regarding dependent Claim 33, Gibson discloses wherein the substrate 300 has an elongate length with a variable aspect ratio along the elongate length thereof (refer to figure 5B showing the capsule/substrate 300 having a typical capsule shape with an elongate length with a variable aspect ratio along the elongate length).
Regarding dependent Claim 34, Gibson discloses wherein the body chamber is a scala tympani of a cochlea 115 of the recipient, wherein the first side of the body chamber is the modiolar wall, and wherein the substrate 300 is configured to, following insertion, have a minimum spacing from a lateral wall of the cochlea (figure 5C shows a spacing between the ports discharging the capsules and a wall of the cochlea 115).
Claims 1, 6, 14 and 15 are rejected under 35 U.S.C. 102a1 as being anticipated by Smyth et al. (US 2021/0308371).
In regards to Independent Claim 1, and with particular reference to Figures 3, 12, 17, Smyth discloses a method, comprising:
inserting a therapeutic substance delivery device 390 into a body chamber 140 of a recipient;
adhering (figure 17 shows the delivery device fixed/adhered to the walls of the cochlea 140) the therapeutic substance delivery device to a surface of the body chamber (whichever surface of the body 140 is in contact with the device); and
delivering, with the therapeutic substance delivery device, one or more therapeutic substances (medication 1277 contained in the reservoir 320, figure 12) to the body chamber.
Regarding dependent Claim 6, Smyth discloses wherein the body chamber is a cochlea canal 140 of the recipient, and wherein adhering the therapeutic substance delivery device 390 to a surface of the body chamber 140 comprises: adhering the therapeutic substance delivery device 390 to a modiolar wall of the cochlea canal (figure 17 shows the device 390 fixed/attached to the walls of the 140).
Regarding dependent Claim 14, Smyth discloses wherein the therapeutic substance delivery device 390 comprises a delivery substrate defining at least one cannula 930 and one or more outlets (referring to figure12, the outlets for discharging the medication 1277) fluidically coupling the at least one cannula 930 to an exterior surface of the delivery substrate, and wherein delivering the one or more therapeutic substances to the body chamber comprises: delivering the one or more therapeutic substances from a source 320 external to the body chamber 140 via the at least one cannula 930 and the one or more outlets, refer to figures 12 and 17.
Regarding dependent Claim 15, Smyth discloses wherein the body chamber 140 is located behind a tissue barrier in the recipient, and wherein the method further comprises: forming an opening (opening shown but not labeled; opening receiving the device 390 in figure 17) in the tissue barrier of the recipient; inserting the therapeutic substance delivery device 390 into the body chamber 140 behind the tissue barrier via the opening; and sealing the opening in the tissue barrier with the therapeutic substance delivery device within the body chamber, as shown in figure 17.
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.
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 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Gibson in view of Churchill (US 2013/0218236).
Regarding dependent Claims 7 and 8, Gibson teaches the invention as claimed and as disclosed above for claim 6, including that the device 200 may be of various lengths and extend into the cochlea 115 to different depths (par. 43).
Gibson does not teach that the different insertions depths are related to a target frequency location within the cochlea. Particularly, Gibson does not teach:
determining a target insertion depth for the therapeutic substance delivery device within the cochlea; and inserting the therapeutic substance delivery device to the target insertion depth (claim 7) or
determining a target insertion depth for the therapeutic substance delivery device within the cochlea comprises: determining a target tonotopic frequency location within the cochlea, and wherein the method further comprises: adhering the therapeutic substance delivery device to a location within the cochlea to deliver one or more therapeutic substances to the target tonotopic frequency location (claim 8).
Churchill teaches a device similar to Gibson and further teaches that doctors implant this type of devices at specific insertion depths in the cochlea in an attempt to replicate the cochlea’s frequency map in normal hearing (pars. 3-4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have determined specific target insertion depths for the device of Gibson (vs. inserting at random), as taught by Churchill, in order to replicate the cochlea’s frequency map in normal hearing so as to improve the quality of life of people (pars. 3-4, 6).
Regarding dependent Claim 9, Gibson in view of Churchill teaches the invention as claimed and as disclosed above including inserting the device at specific insertion depths (pars. 3-4, 6 in Churchill; par. 43 in Gibson). Further, Gibson in view of Churchill teaches wherein determining a target insertion depth for the therapeutic substance delivery device within the cochlea comprises: determining the target insertion depth based on pharmacokinetics modelling (whatever time it takes for the drug-delivery capsule to be completely degraded; par. 52 in Gibson teaches the drug release capsule is comprised of a resorbable material that partially or completely degrades over time through interaction with various body fluids), with the therapeutic substances targeting a particular region of the cochlea (figures 5B-C in Gibson teaches that the therapeutic substance [medication within the capsules 300] is targeting particular regions for there is multiple ports 240 along the cochlea 115, each port discharging the drug-delivery capsule to a particular target region).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The following reference(s) are also relevant for at least claims 1 and 16.
Dadd et al. (US 2011/0288500). Particularly refer to figures 2A, 5A, 6A; par. 53 .
The following reference(s) are also relevant for at least claim 16.
Tobias et al. (US 2013/0324946). Particularly refer to figures 3-4; par. 61-66, 73
Allowable Subject Matter
Claims 10-12 and 30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H RODRIGUEZ whose telephone number is (571)272-4831. The examiner can normally be reached Mon-Fri 8:30-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat Wongwian can be reached at 571-270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H Rodriguez/Primary Examiner, Art Unit 3741