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 without traverse of Group I (claims 1-11) in the reply filed on 5/6/2026 is acknowledged. Applicant has further amended claims 12-25 to make these claims dependent on claim 1 therefore, claims 1-25 are being examined in the current prosecution.
Specification
The disclosure is objected to because of the following informalities:
The reference character “106” has been used to refer to “ossicles” in paragraph 0019, “middle ear” in paragraph 0031 and “middle ear cavity” in paragraph 0031.
The reference character “322” has been used to refer to “first portion” in paragraph 0035, line 6 and “first region” in paragraph 0035, line 6.
The reference character “324” has been used to refer to “second region” in paragraph 0035, line 12 and “second portion” in paragraph 0035, line 14.
Appropriate correction 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 1-7, 12-14 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Specht et al. (US 9,855,420 B2).
Regarding claim 1, Specht teaches an apparatus (figure 1e), comprising:
an electrode 7 (see abstract) configured to be implanted on or within a recipient's body, the electrode comprising:
a first portion 9 having a surface (surface of element 9 coming in contact with patient’s tissue when implanted, column 3, lines 38-40, column 9, lines 4-8) configured to be in electrical communication with the recipient's body;
a second portion 8 integral with the first portion 9 and in mechanical and electrical communication with the first portion (column 9, lines 4-8); and
a plurality of pores (column 3, lines 6-27) extending from the surface of the first portion 9 to the second portion 8 such that the first portion has a substantially non-uniform porosity along a direction (direction of moving from element 9 towards element 8) from the surface to the second portion (column 3, lines 6-27, “incrementally with very small transitional regions or gradually between larger regions”, column 3, lines 56-58).
Regarding claim 2, Specht teaches wherein the substantially non-uniform porosity is monotonically decreasing along the direction from the surface to the second portion 8 (column 3, lines 6-27, column 3, lines 56-58, “incrementally with very small transitional regions or gradually between larger regions”).
Regarding claim 3, Specht teaches wherein the substantially non-uniform porosity has a first value at the surface and a second value at the second portion, the second value less than the first value (column 3, lines 6-27, column 3, lines 56-58, “incrementally with very small transitional regions or gradually between larger regions”, having a higher porosity at element 9 would have higher value compared to the value at element 8).
Regarding claim 4, Specht teaches wherein the substantially non-uniform porosity has a gradient as a function of position along the direction, the gradient being non-zero and substantially continuous along the direction from the surface to the second portion (column 3, lines 6-27, column 3, lines 56-58, “incrementally with very small transitional regions or gradually between larger regions”).
Regarding claim 5, Specht teaches wherein the direction (direction of moving from element 9 towards element 8) is substantially perpendicular to the surface (surface of element 9 coming in contact with patient’s tissue when implanted) and extends towards the second portion 8.
Regarding claim 6, Specht teaches wherein the first portion and the second portion comprise at least one metal (column 4, lines 51-53, column 7, lines 15-25).
Regarding claim 7, Specht teaches wherein at least some of the pores are open (column 5, lines 23-28, column 3, lines 12-16) and/or interconnected with one another to provide fluid communication across at least some of the first portion to the surface.
Regarding claim 12, Specht teaches wherein the first portion 9 comprises an electrically conductive material (column 6, lines 8-22, column 7, lines 50-56) and having a first mass density (density of element 9) and the second portion 8 comprises the electrically conductive material (column 6, lines 8-22), and has a second mass density (density of element 8, since element 8 will have low porosity or no porosity compared to element 9, density of element 8 would be greater than the density of element 9) greater than the first mass density.
Regarding claim 13, Specht teaches wherein the first portion 9 and the second portion 8 are formed using additive manufacturing (see figures 1a-1e).
Regarding claim 14, Specht teaches wherein the electrically conductive material comprises at least one metal, metal alloy, or metal composite (column 7, lines 50-56).
Regarding claim 17, Specht teaches wherein the electrode further comprises a surface region (region comprising element 9) with a ratio of electrochemical surface area to geometric surface area greater than one (column 3, lines 6-27, due to presence of pores especially in element 9, electrochemical surface area will be greater compared to geometric surface area thereby having a ratio greater than one), the surface region (the claimed language is a functional limitation therefore, using appropriate conditions other than body conditions, the electrode could be dissolved overtime with ratio being substantially unchanged by dissolution. If claim requires dissolution due to body fluids then the claim could overcome the rejection) configured to undergo dissolution over time while the electrode on or within the recipient with the ratio being substantially unchanged by the dissolution.
Regarding claim 18, Specht teaches wherein a porosity of the electrode in the surface region is greater than in a non-surface region (region comprising element 8) of the electrode (column 3, lines 6-27, porosity present in 9 is higher than the porosity present in element 8 therefore, porosity will be higher in region near element 9 compared to element 8).
Regarding claim 19, Specht teaches wherein the pores are open (column 5, lines 23-28, column 3, lines 12-16) and/or interconnected and the porosity has a substantially continuous gradation (column 3, lines 6-27, “incrementally with very small transitional regions or gradually between larger regions”, column 3, lines 56-58) as a function of distance from the surface region to the non-surface region.
Regarding claim 20, Specht teaches wherein the pores are closed (column 3, lines 6-27, “incrementally with very small transitional regions or gradually between larger regions”, column 3, lines 56-58, the regions with very small porosity will have pores that are small and closed and the porosity is substantially continuous) and the porosity is substantially continuous.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 8-11, 22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Specht et al. (US 9,855,420 B2) in view of Reenstierna (US 4,162,679).
Regarding claim 8, Specht discloses the claimed invention substantially as claimed, as set forth above in claim 1. Specht is silent regarding wherein the apparatus further comprises an electrical conduit in mechanical and electrical communication with the second portion, the electrical conduit configured to transmit electrical signals between the electrode and a controller of the apparatus.
However, Reenstierna teaches a design of a pacemaker electrode 3 (figure 2) wherein the apparatus further comprises an electrical conduit 2 in mechanical and electrical communication with the second portion 14, the electrical conduit 2 configured to transmit electrical signals between the electrode 3 and a controller 1 (or a power source that provides or transmits power through element 2 to element 3) of the apparatus for the purpose of transmitting stimulation pulses to the heart as needed for treating patient’s specific condition (column 1, lines 6-12).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the apparatus of Specht to incorporate wherein the apparatus further comprises an electrical conduit in mechanical and electrical communication with the second portion, the electrical conduit configured to transmit electrical signals between the electrode and a controller of the apparatus as taught by Reenstierna for the purpose of transmitting stimulation pulses to the heart as needed for treating patient’s specific condition (column 1, lines 6-12).
Regarding claims 9 and 10, Specht discloses the claimed invention substantially as claimed, as set forth above in claim 1. Specht is silent regarding wherein the apparatus further comprises a non-electrically conductive material configured to support the electrode wherein the material comprises silicone.
However, Reenstierna teaches wherein the apparatus (figure 3) further comprises a non-electrically conductive material (material of element 20) configured to support the electrode 3 wherein the material comprises silicone (column 4, lines 17-26) for the purpose of electrically insulating so that the electrical current does not pass in an unintentional area (column 4, lines 17-32).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the apparatus of Specht to incorporate wherein the apparatus further comprises a non-electrically conductive material configured to support the electrode wherein the material comprises silicone as taught by Reenstierna for the purpose of electrically insulating so that the electrical current does not pass in an unintentional area (column 4, lines 17-32).
Regarding claim 11, Specht discloses the claimed invention substantially as claimed, as set forth above in claim 1. Specht is silent regarding wherein the material comprises one or more protrusions and/or recesses configured to mate with one or more recesses and/or protrusion of the electrode.
However, Reenstierna teaches wherein the material (material of element 20) comprises one or more protrusions and/or recesses (portion of element 20 that receives element 17) configured to mate with one or more recesses and/or protrusion 17 of the electrode for the purpose of electrically insulating so that the electrical current does not pass in an unintentional area (column 4, lines 17-32).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the apparatus of Specht to incorporate wherein the material comprises one or more protrusions and/or recesses configured to mate with one or more recesses and/or protrusion of the electrode as taught by Reentierna for the purpose of electrically insulating so that the electrical current does not pass in an unintentional area (column 4, lines 17-32).
Regarding claim 22, Specht discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 21. Specht is silent regarding wherein the second portion is in mechanical and electrical communication with at least one electrical conduit configured to transmit electrical signals to and/or from the electrode.
However, Reentierna teaches the second portion 14 is in mechanical and electrical communication with at least one electrical conduit 2 configured to transmit electrical signals to and/or from the electrode 3 for the purpose of transmitting stimulation pulses to the heart as needed for treating patient’s specific condition (column 1, lines 6-12).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the apparatus of Specht to incorporate wherein the second portion is in mechanical and electrical communication with at least one electrical conduit configured to transmit electrical signals to and/or from the electrode as taught by Reenstierna for the purpose of transmitting stimulation pulses to the heart as needed for treating patient’s specific condition (column 1, lines 6-12).
Regarding claim 25, Specht discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 21. Specht is silent regarding further comprising at least one non-electrically conductive elastomer mechanically bonded with the first portion.
However, Reetierna teaches at least one non-electrically conductive elastomer (material of element 20, column 4, lines 17-26, silicone is an elastomer) mechanically boned with the first portion 14 for the purpose of electrically insulating so that the electrical current does not pass in an unintentional area (column 4, lines 17-32).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the apparatus of Specht to incorporate further comprising at least one non-electrically conductive elastomer mechanically bonded with the first portion as taught by Reenstierna for the purpose of electrically insulating so that the electrical current does not pass in an unintentional area (column 4, lines 17-32).
Claims 1, 12, 16, 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Dadd (US 2010/0094380 A1) in view of Kochinke (US 2018/0296498 A1).
Regarding claim 1, Dadd discloses an apparatus (figure 1) comprising:
an electrode 118 configured to be implanted on or within a recipient's body, the electrode comprising:
a first portion (see “F” in figure 2B below) having a surface (surface of element 148 in contact with the patient’s tissue, paragraph 0033) configured to be in electrical communication with the recipient's body;
a second portion (see “S” in figure 2B below) integral with the first portion (see “F” in figure 2B below) and in mechanical and electrical communication with the first portion (see “F” in figure 2B below, element “S” in figure 2B below is integral and in mechanical and electrical communication since “S” and “F” are part of element 148); and
a plurality of pores (paragraph 0060, lines 8-11) extending from the surface of the first portion (see “F” in figure 2B below) to the second portion (see “S” in figure 2B below) but is silent regarding such that the first portion has a substantially non-uniform porosity along a direction from the surface to the second portion.
However, Kochinke teaches a design of a transdermal delivery system 10 (figure 1) comprising a drug reservoir comprising a plurality of pores such that the first portion (uppermost region and region between the uppermost region and the lowermost region, paragraph 0091, lines 3-7) has a substantially non-uniform porosity along a direction from the surface to the second portion (lowermost region, paragraph 0091, lines 3-7) for the purpose of controlling the flux of one or more formulation components out of the drug reservoir (paragraph 0091, lines 8-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the porous electrode of Dadd to incorporate a plurality of pores such that the first portion has a substantially non-uniform porosity along a direction from the surface to the second portion as taught by Kochinke for the purpose of controlling the flux of one or more formulation components out of the drug reservoir (porous electrode in Dadd modified in view of Kochinke) (paragraph 0091, lines 8-9).
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Regarding claim 12, Dadd discloses wherein the first portion (see “F” in figure 2B above) comprises an electrically conductive material (paragraph 0037, lines 10-12, “platinum”) and having a first mass density (density of “F” in figure 2B above) and the second portion (see “S” in figure 2B above) comprises the electrically conductive material (paragraph 0037, lines 10-12, “platinum”) and has a second mass density (density of “S” in figure 2B above). Dadd is silent regarding a second mass density greater than the first mass density.
However, Kochinke teaches the first portion having the first mass density and the second portion having the second mass density greater than the first mass density (paragraph 0091, lines 3-7, since the uppermost region will have more pores compared to lowermost region, the mass density in lowermost region will be higher than the mass density in the uppermost region) for the purpose of controlling the flux of one or more formulation components out of the drug reservoir (porous electrode in Dadd modified in view of Kochinke) (paragraph 0091, lines 8-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the mass density of the first and second portions of Dadd to incorporate a second mass density greater than the first mass density as taught by Kochinke for the purpose of controlling the flux of one or more formulation components out of the drug reservoir (porous electrode in Dadd modified in view of Kochinke) (paragraph 0091, lines 8-9).
Regarding claim 16, Dadd discloses wherein the electrode 118 is configured to be implanted on or within a recipient’s body (figure 1) and comprises at least one medicament in at least some of the pores (paragraph 0060, lines 8-11), the at least one medicament (paragraph 0055, paragraph 0060, lines 8-11) configured to controllably flow out of the pores while the electrode is implanted on or within the recipient’s body.
Regarding claim 21, Dadd is silent regarding wherein the surface of the first portion is porous, the second portion is substantially non-porous, and the porosity of the first portion along the direction from the surface to the second portion varies as a function of position along the distance, monotonically decreasing along the distance, and has a non-zero and substantially constant gradient as a function of position along the distance.
However, Kochinke teaches wherein the surface (paragraph 0091, lines 3-7, surface of “uppermost”) of the first portion (“uppermost”, paragraph 0091, lines 3-7) is porous, the second portion (“lowermost”, paragraph 0091, lines 3-7) is substantially non-porous, and the porosity of the first portion along the direction from the surface to the second portion varies as a function of position along the distance, monotonically decreasing along the distance, and has a non-zero and substantially constant gradient as a function of position along the distance (paragraph 0091, lines 3-7) for the purpose of controlling the flux of one or more formulation components out of the drug reservoir (porous electrode in Dadd modified in view of Kochinke) (paragraph 0091, lines 8-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the surface of the first portion and the second portion of Dadd to incorporate wherein the surface of the first portion is porous, the second portion is substantially non-porous, and the porosity of the first portion along the direction from the surface to the second portion varies as a function of position along the distance, monotonically decreasing along the distance, and has a non-zero and substantially constant gradient as a function of position along the distance as taught by Kochinke for the purpose of controlling the flux of one or more formulation components out of the drug reservoir (porous electrode in Dadd modified in view of Kochinke) (paragraph 0091, lines 8-9).
Dadd/Kochinke (hereinafter referred as “modified Dadd”) does not explicitly disclose the porosity of the first portion along the direction from the surface to the second portion varies by more than 10% as a function of position along the distance, as required by the claim. There is no evidence of record that establishes that changing the variation would result in a difference in function of modified Dadd device. Further, a person having ordinary skill in the art, being faced with modifying the porosity of modified Dadd would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended being given the claimed porosity variation. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the porosity “may” be more than the claimed range and offering other acceptable ranges (paragraph 0049, “more than 50%; by more than 40%; by more than 30%; by more than 20%”) and therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the porosity variation of modified Dadd to incorporate the porosity of the first portion along the direction from the surface to the second portion varies by more than 10% as a function of position along the distance as an obvious matter of design choice within the skill of the art.
Regarding claim 24, Dadd discloses further comprising at least one medicament within at least some of the pores (paragraph 0060, lines 8-11).
Claims 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Specht et al. (US 9,855,420 B2).
Regarding claim 21, Specht discloses the claimed invention substantially as claimed, as set forth above in claim 1. Specht further discloses wherein the surface of the first portion 9 is porous, the second portion 8 is substantially non-porous, and the porosity of the first portion along the direction from the surface to the second portion varies as a function of position along the distance, monotonically decreasing along the distance, and has a non-zero and substantially continuous gradient as a function of position along the distance (column 3, lines 6-27, “incrementally with very small transitional regions or gradually between larger regions”, column 3, lines 56-58).
However, Specht does not explicitly disclose the porosity of the first portion along the direction from the surface to the second portion varies by more than 10% as a function of position along the distance, as required by the claim. There is no evidence of record that establishes that changing the variation would result in a difference in function of Specht device. Further, a person having ordinary skill in the art, being faced with modifying the porosity of Specht would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended being given the claimed porosity variation. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the porosity “may” be more than the claimed range and offering other acceptable ranges (paragraph 0049, “more than 50%; by more than 40%; by more than 30%; by more than 20%”) and therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the porosity variation of Specht to incorporate the porosity of the first portion along the direction from the surface to the second portion varies by more than 10% as a function of position along the distance as an obvious matter of design choice within the skill of the art.
Regarding claim 23, Specht discloses the claimed invention substantially as claimed, as set forth above in claim 1. Specht further discloses wherein the surface has a ratio of electrochemical surface area to geometric surface area greater than one (column 3, lines 6-27, due to presence of pores especially in element 9, electrochemical surface area will be greater compared to geometric surface area thereby having a ratio greater than one).
Allowable Subject Matter
Claim 15 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.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Specht et al. (US 9,855,420 B2) in view of Reenstierna (US 4,162,679), is silent regarding the electrically insulative solid element comprising at least one non-electrically conductive elastomer in at least some of the pores and overlaying the first portion in combination with other claimed limitations of claim 15.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cannon et al. (US 4,606,118), Stokes (US 4,577,642), Heil, Jr. et al. (US 4,819,662): discloses a design of a porous electrode and comprising medication to be delivered to the patient.
Rubinson et al. (US 2013/0001090 a1): discloses a design and method of manufacturing a polymer film bioelectrodes with gradient porosity.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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