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, species A, and species C in the reply filed on 2/9/2026 is acknowledged.
New claims 45-55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/9/2026. Group I (Claims 1-6, 8-11, and 13-18) and new claims 44-55 do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: Group I (Claims 1-6, 8-11, and 13-18) and new claims 44-55 lack unity of invention with each other because even though the inventions of these groups require the technical feature of a carrier member comprising a plurality of electroporation electrodes, wherein the carrier member is configured to be inserted into a spatial region within a body of a recipient, a treatment material configured to be introduced into the spatial region, and a population of cells located adjacent to the spatial region being configured to be dynamically electroporated to transfer the treatment material into the population of cells, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Kumar (U.S. PG publication 20150100011). Specifically, Kumar discloses a carrier member (figure 7, item 728) comprising a plurality of electroporation electrodes (figure 7, item 748A and 748B), wherein the carrier member is configured to be inserted into a spatial region (part of cochlea that the distal end of the carrier member 728 is within) within a body of a recipient (paragraph [0067]-[0069] and [0080]), a treatment material (optically-sensitive elements within a solution; paragraph [0082]-[0083]) configured to be introduced into the spatial region (paragraph [0080]-[0083]), and a population of cells located adjacent to the spatial region (population of cells in the cochlea located adjacent the spatial region in which a proximal end of the carrier member is within or which the carrier member is not within) configured to be dynamically electroporated to transfer the treatment material into the population of cells (Examiner notes “configured to be dynamically electroporated to transfer the treatment material into the population of cells” is a functional limitation. The population of cells is fully capable of being dynamically electroporated to transfer the treatment material into the population of cells as supported by paragraph [0008], [0067]-[0069], [0070], and paragraph [0113]). Therefore, the shared technical feature between groups I and new claims 44-55 is known in the art.
Claim 4 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/9/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/8/2023 and 5/15/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: item 132, 134, and 119.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because:
Line 1 recites “the cells”. As the cells have not been previously introduced, Examiner suggests replacing “the cells” with “cells” in line 1 to put the abstract in clearer form.
Line 2 recites “cells of the recipient”. Examiner suggests replacing “cells of the recipient” with “the cells of the recipient” to put the abstract in clearer form as the cells of line 2 appear to be the same as the cells of line 1.
Line 5 recites “the electroporation electrodes”. Examiner suggests replacing “the electroporation electrodes” in line 5 with “the one or more electroporation electrodes” to put the abstract in clearer form and clearly refer to the one or more electroporation electrodes previously introduced in the abstract.
Line 6-7 recites “the electroporation electrodes”. Examiner suggests replacing “the electroporation electrodes” in line 6-7 with “the one or more electroporation electrodes” to put the abstract in clearer form and clearly refer to the one or more electroporation electrodes previously introduced in the abstract.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
This application is a 371 of PCT/IB2021/058028 filed 9/2/2021 which claims priority to provisional application 63/078,556 filed 9/15/2020. This continuity data should be included under the heading “Cross-References to Related Applications” under the title.
Appropriate correction is required.
Claim Objections
Claim 13 objected to because of the following informalities:
Line 1-2 recites “the plurality of electroporation electrodes are disposed”. This is grammatically incorrect as the term plurality is singular. Examiner suggests replacing “the plurality of electroporation electrodes are disposed” in line 1-2 of claim 13 with “the plurality of electroporation electrodes is disposed”.
Claim 14 objected to because of the following informalities:
Line 4 recites “the plurality of stimulation electrodes are”. This is grammatically incorrect as the term plurality is singular. Examiner suggests replacing “the plurality of stimulation electrodes are” in line 4 of claim 14 with “the plurality of stimulation electrodes is”.
Claim 15 objected to because of the following informalities:
Line 1 recites “The method of claim 1, inserting”. Examiner suggests replacing “The method of claim 1, inserting” in line 1 with “The method of claim 1, wherein inserting” to put the claim in clearer grammatical form.
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 2-3, 5-6, 8-10, and 15-18 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.
In regard to claim 2,
Line 2, 4-5, and 5-6 recites “the population of cells”. Line 1 of claim 2 recites “a population of cells”. Line 5 of claim 1, which claim 2 depends on, also recites “a population of cells”. It is unclear which population of cells line 2, 4-5, and 5-6 of claim 2 refers to. For examination purposes Examiner construes the population of cells in claim 1 and line 1 of claim 2 to be the same. Examiner suggests replacing “a population of cells” in line 1 of claim 2 with “the population of cells”.
Examiner notes claims 3 and 5 are similarly rejected by virtue of their dependency on claim 2.
In regard to claim 3,
Line 2 recites “the population of cells”. Line 1 of claim 2, which claim 3 depends on, recites “a population of cells”. Line 5 of claim 1, which claim 3 depends on, also recites “a population of cells”. It is unclear which population of cells line 2 of claim 3 refers to. For examination purposes Examiner construes the population of cells in claim 1 and line 1 of claim 2 to be the same. Examiner suggests replacing “a population of cells” in line 1 of claim 2 with “the population of cells”.
In regard to claim 5,
Line 2 and line 3 recites “the population of cells”. Line 1 of claim 2, which claim 5 depends on, recites “a population of cells”. Line 5 of claim 1, which claim 5 depends on, also recites “a population of cells”. It is unclear which population of cells line 2 and line 3 of claim 5 refers to. For examination purposes Examiner construes the population of cells in claim 1 and line 1 of claim 2 to be the same. Examiner suggests replacing “a population of cells” in line 1 of claim 2 with “the population of cells”.
In regard to claim 6,
Line 2-3 recites “the population of cells”. Line 1-2 of claim 6 recites “a population of cells”. Line 5 of claim 1, which claim 6 depends on, also recites “a population of cells”. It is unclear which population of cells line 2-3 of claim 6 refers to. For examination purposes Examiner construes the population of cells in claim 1 and line 1-2 of claim 6 to be the same. Examiner suggests replacing “a population of cells” in line 1-2 of claim 6 with “the population of cells”.
Examiner notes claims 8-10 are similarly rejected by virtue of their dependency on claim 6.
In regard to claim 9,
Line 2 recites “a recipient”. Claim 9 depends on claim 8, 6, and 1. Claim 1 introduces a recipient. It is unclear if claim 9 is intending to refer to the recipient of claim 1 or introduce a second recipient. For examination purposes Examiner construes the recipient in claim 9 and 1 to be the same. Examiner suggests replacing “a recipient” in line 2 of claim 9 with “the recipient”.
In regard to claim 10,
Line 2 recites “a series of current pulses”. Claim 10 depends on claim 6 and claim 1. Claim 6 recites “a series of current pulses”. It is unclear if claim 10 is intending to refer to the series of current pulses of claim 6 or introduce a second series of current pulses. For examination purposes Examiner construes the series of current pulses of claim 10 to be the same as claim 6. Examiner suggests replacing “a series of current pulses” in line 2 of claim 10 with “the series of current pulses”.
In regard to claim 15,
Line 1-2 recites “a plurality of electroporation electrodes”. Claim 15 depends on claim 1. Claim 1 introduces a plurality of electroporation electrodes. It is unclear if the plurality of electroporation electrodes of claim 15 is intended to be the same as the plurality of electroporation electrodes of claim 1 or if the plurality of electroporation electrodes of claim 15 is a second plurality of electroporation electrodes. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “a plurality of electroporation electrodes” in line 1-2 of claim 15 with “the plurality of electroporation electrodes”.
Line 2 recites “a spatial region”. Claim 15 depends on claim 1. Claim 1 introduces a spatial region. It is unclear if the spatial region of claim 15 is intended to be the same as the spatial region of claim 1 or if the spatial region of claim 15 is a second spatial region. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “a spatial region” in line 2 of claim 15 with “the spatial region”.
Line 4 recites “the carrier member”. Line 1 of claim 15 recites “a carrier member”. Claim 1, which claim 15 depends on, also introduces a carrier member. It is unclear which carrier member the carrier member of line 4 of claim 15 refers to. For examination purposes Examiner construes the carrier member of claim 1 and line 1 of claim 15 to be the same. Examiner suggests replacing “a carrier member” in line 1 of claim 15 with “the carrier member”.
Line 4 recites “the recipient”. Line 2 of claim 15 recites “a recipient”. Claim 1, which claim 15 depends on, also introduces a recipient. It is unclear which recipient the recipient of line 4 of claim 15 refers to. For examination purposes Examiner construes the recipient of claim 1 and line 1 of claim 15 to be the same. Examiner suggests replacing “a recipient” in line 2 of claim 15 with “the recipient”.
In regard to claim 16,
Line 3 recites “the treatment material”. Line 1 of claim 16 recites “a treatment materiel”. Claim 1, which claim 16 depends on, also introduces a treatment materiel. It is unclear which treatment materiel the treatment materiel of line 3 of claim 16 refers to. For examination purposes Examiner construes the treatment materiel of claim 1 and line 1 of claim 16 to be the same. Examiner suggests replacing “a treatment materiel” in line 1 of claim 16 with “the treatment materiel”.
In regard to claim 17,
Line 4 recites “the cells”. Claim 17 depends on claim 16 and claim 1. Claim 1 introduces a population of cells. It is unclear if the cells of line 4 are specific cells of the population of cells or if the cells are the same as the population of cells. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the cells” in line 4 with “the population of cells”.
Line 5 recites “the treatment material”. Claim 17 depends on claim 16 and claim 1. Claim 16 introduces a treatment material and claim 1 introduces a treatment material. It is unclear which treatment materiel the treatment materiel of line 5 of claim 17 refers to. For examination purposes Examiner construes the treatment materiel of claim 1 and claim 16 to be the same. Examiner suggests replacing “a treatment materiel” in line 1 of claim 16 with “the treatment materiel”.
In regard to claim 18,
Line 3 and line 5 recite “the treatment material”. Claim 18 depends on claim 16 and claim 1. Claim 16 introduces a treatment material and claim 1 introduces a treatment material. It is unclear which treatment materiel the treatment materiel of line 3 and line 5 of claim 18 refer to. For examination purposes Examiner construes the treatment materiel of claim 1 and claim 16 to be the same. Examiner suggests replacing “a treatment materiel” in line 1 of claim 16 with “the treatment materiel”.
Line 4 recites “the solution”. Line 2 of claim 18 recites “a solution”. Claim 16, which claim 18 depends on also introduces a solution. It is unclear which solution the solution of line 4 of claim 18 refers to. For examination purposes Examiner construes the solution in claim 16 and line 2 of claim 18 to be the same. Examiner suggests replacing “a solution” in line 2 of claim 18 with “the solution”.
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 1-2, 13, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kumar (U.S. PG publication 20150100011).
In regard to claim 1,
Kumar discloses a method (paragraph [0007]-[0008], [0066]-[0071], [0080]-[0083], and [0113]; see figure 6A-6B and figure 7), comprising:
inserting a carrier member (figure 7, item 728) comprising a plurality of electroporation electrodes (figure 7, item 748A and 748B) into a spatial region (part of cochlea that the distal end of the carrier member 728 is within) within a body of a recipient (paragraph [0067]-[0069] and [0080]);
introducing a treatment material (optically-sensitive elements within a solution; paragraph [0082]-[0083]) into the spatial region (paragraph [0080]-[0083]); and
dynamically electroporating a population of cells located adjacent to the spatial region (see the population of cells in the cochlea located adjacent the spatial region in which a proximal end of the carrier member is within or which the carrier member is not within. Examiner notes the term “dynamically” means moving as defined in paragraph [0025] of the instant disclosure. See paragraph [0070] of Kumar which states “In accordance with certain embodiments, multipolar or other focused stimulation modes may be used to "steer" the electric field to other regions of the cochlea and/or the surrounding area so that transfection can occur at other sites. Paragraph [0070] supports that the electric field can be adjusted to modify the location of the electric field to electroporate other regions of the cochlea and/or surrounding area. See also figure 6A compared to figure 6B and paragraph [0067]-[0069] which also supports the population of cells can be dynamically electroporated by changing the size/location of the electric field; see also paragraph [0113] which states “The method may further comprise delivering a focused electrical field to a population of the cells such that the optically-sensitive elements are transfected into the cells and/or delivering a wide electrical field to a population of the cells such that the optically-sensitive elements are transfected into the cells. Paragraph [0113] therefore supports both a focused and wide electrical field can be applied during a method) to transfer the treatment material into the population of cells (paragraph [0008], [0067]-[0071] and [0082]).
In regard to claim 2,
Kumar discloses the method of claim 1, wherein dynamically electroporating a population of cells located adjacent to the spatial region to transfer the treatment material into the population of cells comprises:
delivering, via the plurality of electroporation electrodes, electroporation signals to the population of cells to generate a dynamic electroporation electrical field proximate (Examiner notes the term “proximate” is construed as nearby) to the population of cells with the plurality of electroporation electrodes (see analysis of claim 1 above; paragraph [0067]-[0070]; see also figure 6A and 6B), wherein a location of a locus of the dynamic electroporation electrical field experiences a time-varying change through the spatial region (see analysis of claim 1 above; paragraph [0067]-[0070]; Examiner notes a location of a locus of the dynamic electroporation electrical field experiences a time-varying change through the spatial region due to the location/size of the electrical field changing).
In regard to claim 13,
Kumar discloses the method of claim 1, wherein the plurality of electroporation electrodes are disposed at a distal end of the carrier member (see figure 7 and analysis of claim 1 above).
In regard to claim 16,
Kumar discloses the method of claim 1, wherein introducing a treatment material into the spatial region comprises:
delivering a solution comprising the treatment material to the spatial region (see analysis of claim 1 above and paragraph [0082]-[0083]).
In regard to claim 17,
Kumar discloses the method of claim 16, further comprising:
bringing one or more of the plurality of electroporation electrodes or one or more portions of the carrier member adjacent to one or more of the plurality of electroporation electrodes in contact with the cells located adjacent to the spatial region to substantially seal the solution comprising the treatment material within the spatial region for a period of time (paragraph [0083]; Examiner notes when one or more portions of the carrier member adjacent to one or more of the plurality of electroporation electrodes are brought in contact with the cells located adjacent to the spatial region, the solution comprising the treatment material within the spatial region is substantially sealed for a period of time due to the structure of the carrier member and ports).
In regard to claim 18,
Kumar discloses the method of claim 16, wherein the carrier member comprises an elongate cannula (figure 7, item 760 or figure 7, item 766) extending a length of the carrier member (see figure 7), and wherein delivering a solution comprising the treatment material to the spatial region comprises:
delivering the solution comprising the treatment material to the spatial region via the elongate cannula (paragraph [0081]-[0083]).
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 3, 6, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar (U.S. PG publication 20150100011) further in view of Sahakian (U.S. PG publication 20160113707).
In regard to claim 3,
Kumar discloses the method of claim 2.
Kumar is silent as to further comprising: while delivering the electroporation signals to the population of cells, moving the carrier member in a distal direction from a first position proximal to an external environment of the recipient to a second position distal to the external environment to create the time-varying change in the location of the locus of the dynamic electroporation electrical field through the spatial region.
Sahakian teaches further comprising: while delivering the electroporation signals to the population of cells, moving the carrier member in a distal direction from a first position proximal to an external environment of the recipient to a second position distal to the external environment to create the time-varying change in the location of the locus of the dynamic electroporation electrical field through the spatial region (paragraph [0034]-[0035]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kumar to include further comprising: while delivering the electroporation signals to the population of cells, moving the carrier member in a distal direction from a first position proximal to an external environment of the recipient to a second position distal to the external environment to create the time-varying change in the location of the locus of the dynamic electroporation electrical field through the spatial region, as taught by Sahakian, for the purpose of creating three-dimensional regions of electroporation with desired shapes and sizes (paragraph [0034] of Sahakian). Examiner notes one of ordinary skill in the art would recognize based on the teachings of Sahakian that the carrier member of Kumar can be repositioned depending on the desired region of electroporation.
In regard to claim 6,
Kumar discloses the method of claim 1, wherein dynamically electroporating a population of cells located adjacent to the spatial region to transfer the treatment material into the population of cells comprises:
delivering a series of current pulses from an external electroporation device (device which supplies signal to the plurality of electroporation electrodes; paragraph [0065]) to the plurality of electroporation electrodes (see analysis of claim 1 above and paragraph [0067]-[0070]).
Kumar is silent as to wherein dynamically electroporating a population of cells located adjacent to the spatial region to transfer the treatment material into the population of cells comprises: moving the carrier member along a path through the spatial region while simultaneously delivering a series of current pulses from an external electroporation device to the plurality of electroporation electrodes.
Sahakian teaches wherein dynamically electroporating a population of cells located adjacent to the spatial region to transfer the treatment material into the population of cells comprises: moving the carrier member along a path through the spatial region while simultaneously delivering a series of current pulses from an external electroporation device to the plurality of electroporation electrodes (paragraph [0034]-[0035]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kumar to include wherein dynamically electroporating a population of cells located adjacent to the spatial region to transfer the treatment material into the population of cells comprises: moving the carrier member along a path through the spatial region while simultaneously delivering a series of current pulses from an external electroporation device to the plurality of electroporation electrodes, as taught by Sahakian, for the purpose of creating three-dimensional regions of electroporation with desired shapes and sizes (paragraph [0034] of Sahakian). Examiner notes one of ordinary skill in the art would recognize based on the teachings of Sahakian that the carrier member of Kumar can be repositioned while simultaneously delivering a series of current pulses from an external electroporation device to the plurality of electroporation electrodes depending on the desired region of electroporation.
In regard to claim 10,
Kumar in view of Sahakian teaches the method of claim 6, wherein moving the carrier member along the path through the spatial region while simultaneously delivering a series of current pulses from the external electroporation device to the plurality of electroporation electrodes comprises:
moving the carrier member along the path in a stepwise manner (see analysis of claim 6 above and paragraph [0034]-[0035] of Sahakian); and
applying one or more current pulses at each of a plurality of discrete positions along the path (see analysis of claim 6 above and paragraph [0034]-[0035] of Sahakian).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kumar (U.S. PG publication 20150100011) further in view of Murphy (U.S. PG publication 20170368331).
In regard to claim 5,
Kumar discloses the method of claim 2.
Kumar is silent as to wherein delivering electroporation signals to the population of cells comprises: delivering a series of biphasic current pulses to the population of cells.
Murphy teaches wherein delivering electroporation signals to the population of cells comprises: delivering a series of biphasic current pulses to the population of cells (paragraph [0047]-[0050]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kumar to substitute biphasic current pulses in place of the currant pulses of Kumar, as taught by Murphy, therefore resulting in wherein delivering electroporation signals to the population of cells comprises: delivering a series of biphasic current pulses to the population of cells because the substitution is a simple substitution that would yield the same predictable result of causing electroporation (see paragraph [0047]-[0050] of Murphy and paragraph [0066] of Kumar). Furthermore, Kumar supports modifications can be made (paragraph [0116]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kumar (U.S. PG publication 20150100011) further in view of Housley (U.S. PG publication 20120191032).
In regard to claim 15,
Kumar discloses the method of claim 1.
Kumar is silent as to inserting a carrier member comprising a plurality of electroporation electrodes into a spatial region within the body of a recipient comprises: inserting the carrier member into a scala tympani of the recipient.
Housley teaches inserting a carrier member comprising a plurality of electroporation electrodes into a spatial region within the body of a recipient comprises: inserting the carrier member into a scala tympani of the recipient (paragraph [0007],[0090] and [0093]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kumar to include inserting a carrier member comprising a plurality of electroporation electrodes into a spatial region within the body of a recipient comprises: inserting the carrier member into a scala tympani of the recipient, as taught by Housley, for the purpose of targeting a useful location to restore hearing (paragraph [0093] of Housley).
Claims 1-2, 5, 13-14, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy (U.S. PG publication 20170368331) further in view of Kumar (U.S. PG publication 20150100011).
In regard to claim 1,
Murphy discloses a method (paragraph [0003], [0034], [0036]-[0037], [0039]-[0040]) comprising:
inserting a carrier member (figure 2, item 145) comprising a plurality of electroporation electrodes (figure 2, item 150) into a spatial region within a body of a recipient (Examiner notes the spatial region is construed as the part of the cochlea that the distal end of the carrier member is inserted within);
introducing a treatment material into the spatial region (paragraph [0036]-[0037] and [0039]); and
electroporating a population of cells located adjacent to the spatial region (population of cells in the cochlea located adjacent the spatial region in which a proximal portion of the carrier member is within or which the carrier member is not within; Paragraph [0056] states “multipolar or other focused stimulation modes may be used to “steer” the electric field to other regions of the cochlea and/or the surrounding area so that electroporation can occur at other sites”; paragraph [0054]-[0056] supports that the insertion tools can make use of a number of different electrical stimulation strategies or modes including, for example, using monopolar stimulation, multipolar stimulation, common ground mode, etc. to cause electroporation of the cochlea nerve cells. The various stimulation modes that may be used differ from another in the shape of the electrical field generated within each stimulation mode; paragraph [0063]-[0066] supports that the functional arrangement of the electrodes and/or the utilized stimulating mode is configurable (adjustable) via a switching circuit) to transfer the treatment material into the population of cells (paragraph [0037] and [0040]).
Although Murphy supports the plurality of electroporation electrodes can be used in different modes (paragraph [0054]-[0056] and [0063]-[0066]), Murphy is silent as to dynamically electroporating a population of cells located adjacent to the spatial region to transfer the treatment material into the population of cells.
Kumar teaches dynamically electroporating a population of cells located adjacent to the spatial region (population of cells in the cochlea located adjacent the spatial region in which a proximal end of the carrier member is within or which the carrier member is not within; See figure 6A compared to figure 6B and paragraph [0067]-[0069] which also supports the population of cells can be dynamically electroporated by changing the size/location of the electric field; see also paragraph [0070] which details some types of cells can be damaged by repetitive stimulation and supports multipolar or other focused stimulation modes could be used to steer the electroporation electric field away from these types of cells; see also paragraph [0113] which states “The method may further comprise delivering a focused electrical field to a population of the cells such that the optically-sensitive elements are transfected into the cells and/or delivering a wide electrical field to a population of the cells such that the optically-sensitive elements are transfected into the cells. Paragraph [0113] therefore supports both a focused and wide electrical field can be applied in a method) to transfer the treatment material into the population of cells (paragraph [0008], [0067]-[0070] and [0082]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Murphy to include dynamically electroporating a population of cells located adjacent to the spatial region to transfer the treatment material into the population of cells, as taught by Kumar, for the purpose of selectively controlling the area of electroporation to effectively transfer the treatment material and limit damage of cells (paragraph [0067]-[0070] of Kumar).
In regard to claim 2,
Murphy in view of Kumar teaches the method of claim 1, wherein dynamically electroporating a population of cells located adjacent to the spatial region to transfer the treatment material into the population of cells comprises:
delivering, via the plurality of electroporation electrodes, electroporation signals to the population of cells to generate a dynamic electroporation electrical field proximate to the population of cells with the plurality of electroporation electrodes, wherein a location of a locus of the dynamic electroporation electrical field experiences a time-varying change through the spatial region (see analysis of claim 1 above; paragraph [0067]-[0070] of Kumar; Examiner notes a location of a locus of the dynamic electroporation electrical field experiences a time-varying change through the spatial region due to the location/size of the electrical field changing).
In regard to claim 5,
Murphy in view of Kumar teaches the method of claim 2, wherein delivering electroporation signals to the population of cells comprises:
delivering a series of biphasic current pulses to the population of cells (paragraph [0047]-[0052] of Murphy).
In regard to claim 13,
Murphy in view of Kumar teaches the method of claim 1, wherein the plurality of electroporation electrodes are disposed at a distal end of the carrier member (see analysis of claim 1 above and figure 2 of Murphy).
In regard to claim 14,
Murphy in view of Kumar teaches the method of claim 1, further comprising:
removing the carrier member from the spatial region (paragraph [0033] and [0086] of Murphy); and
inserting a stimulating assembly (item 118 of Murphy) comprising a plurality of stimulation electrodes into the spatial region (paragraph [0028] and [0030] of Murphy and paragraph [0034] and [0086] of Murphy), wherein the plurality of stimulation electrodes are configured to deliver stimulation signals to the population of cells of the recipient (Examiner notes “configured to deliver stimulation signals to the population of cells of the recipient” is a functional limitation. The plurality of stimulation electrodes are fully capable of the recited function as supported by paragraph [0031] of Murphy).
In regard to claim 16,
Murphy in view of Kumar teaches the method of claim 1, wherein introducing a treatment material into the spatial region comprises:
delivering a solution comprising the treatment material to the spatial region (paragraph [0036], [0039], [0069] of Murphy).
In regard to claim 18,
Murphy in view of Kumar teaches the method of claim 16, wherein the carrier member comprises an elongate cannula (paragraph [0039] of Murphy) extending a length of the carrier member (paragraph [0039] of Murphy), and wherein delivering a solution comprising the treatment material to the spatial region comprises:
delivering the solution comprising the treatment material to the spatial region via the elongate cannula (paragraph [0039] of Murphy).
Claims 3, 6, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy (U.S. PG publication 20170368331) in view of Kumar (U.S. PG publication 20150100011) further in view of Sahakian (U.S. PG publication 20160113707).
In regard to claim 3,
Murphy in view of Kumar teaches the method of claim 2.
Murphy in view of Kumar is silent as to further comprising: while delivering the electroporation signals to the population of cells, moving the carrier member in a distal direction from a first position proximal to an external environment of the recipient to a second position distal to the external environment to create the time-varying change in the location of the locus of the dynamic electroporation electrical field through the spatial region.
Sahakian teaches further comprising: while delivering the electroporation signals to the population of cells, moving the carrier member in a distal direction from a first position proximal to an external environment of the recipient to a second position distal to the external environment to create the time-varying change in the location of the locus of the dynamic electroporation electrical field through the spatial region (paragraph [0034]-[0035]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Murphy in view of Kumar to include further comprising: while delivering the electroporation signals to the population of cells, moving the carrier member in a distal direction from a first position proximal to an external environment of the recipient to a second position distal to the external environment to create the time-varying change in the location of the locus of the dynamic electroporation electrical field through the spatial region, as taught by Sahakian, for the purpose of creating three-dimensional regions of electroporation with desired shapes and sizes (paragraph [0034] of Sahakian). Examiner notes one of ordinary skill in the art would recognize based on the teachings of Sahakian that the carrier member of Murphy in view of Kumar can be repositioned depending on the desired region of electroporation.
In regard to claim 6,
Murphy in view of Kumar teaches the method of claim 1, wherein dynamically electroporating a population of cells located adjacent to the spatial region to transfer the treatment material into the population of cells comprises:
delivering a series of current pulses (paragraph [0047]-[0048] and [0051]-[0052] of Murphy) from an external electroporation device (external current source; paragraph [0046] of Murphy) to the plurality of electroporation electrodes (paragraph [0046] of Murphy, see figure 2 of Murphy).
Murphy in view of Kumar is silent as to wherein dynamically electroporating a population of cells located adjacent to the spatial region to transfer the treatment material into the population of cells comprises: moving the carrier member along a path through the spatial region while simultaneously delivering a series of current pulses from an external electroporation device to the plurality of electroporation electrodes.
Sahakian teaches wherein dynamically electroporating a population of cells located adjacent to the spatial region to transfer the treatment material into the population of cells comprises: moving the carrier member along a path through the spatial region while simultaneously delivering a series of current pulses from an external electroporation device to the plurality of electroporation electrodes (paragraph [0034]-[0035]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Murphy in view of Kumar to include wherein dynamically electroporating a population of cells located adjacent to the spatial region to transfer the treatment material into the population of cells comprises: moving the carrier member along a path through the spatial region while simultaneously delivering a series of current pulses from an external electroporation device to the plurality of electroporation electrodes, as taught by Sahakian, for the purpose of creating three-dimensional regions of electroporation with desired shapes and sizes (paragraph [0034] of Sahakian). Examiner notes one of ordinary skill in the art would recognize based on the teachings of Sahakian that the carrier member of Murphy in view of Kumar can be repositioned while simultaneously delivering a series of current pulses from an external electroporation device to the plurality of electroporation electrodes depending on the desired region of electroporation.
In regard to claim 10,
Murphy in view of Kumar in view of Sahakian teaches the method of claim 6, wherein moving the carrier member along the path through the spatial region while simultaneously delivering a series of current pulses from the external electroporation device to the plurality of electroporation electrodes comprises:
moving the carrier member along the path in a stepwise manner (see analysis of claim 6 above and paragraph [0034]-[0035] of Sahakian); and
applying one or more current pulses at each of a plurality of discrete positions along the path (see analysis of claim 6 above and paragraph [0034]-[0035] of Sahakian).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Murphy (U.S. PG publication 20170368331) in view of Kumar (U.S. PG publication 20150100011) further in view of Housley (U.S. PG publication 20120191032).
In regard to claim 15,
Murphy in view of Kumar teaches the method of claim 1.
Murphy in view of Kumar is silent as to inserting a carrier member comprising a plurality of electroporation electrodes into a spatial region within the body of a recipient comprises: inserting the carrier member into a scala tympani of the recipient.
Housley teaches inserting a carrier member comprising a plurality of electroporation electrodes into a spatial region within the body of a recipient comprises: inserting the carrier member into a scala tympani of the recipient (paragraph [0007],[0090] and [0093]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Murphy in view of Kumar to include inserting a carrier member comprising a plurality of electroporation electrodes into a spatial region within the body of a recipient comprises: inserting the carrier member into a scala tympani of the recipient, as taught by Housley, for the purpose of targeting a useful location to restore hearing (paragraph [0093] of Housley).
Allowable Subject Matter
Claims 8-9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Examiner notes the indication of allowability is on the condition that the claims are amended in such a way as to be in line with the interpretation that has been applied in view of the rejections under 35 U.S.C. 112(b) and any other amendments to the claims may affect their allowability.
The following is a statement of reasons for the indication of allowable subject matter:
In regard to claim 8,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations the method of claim 6, further comprising: varying, at one or more locations in the spatial region, a rate at which the carrier member is moved through the spatial region. Murphy (U.S. PG publication 20170368331), Kumar (U.S. PG publication 20150100011), and Sahakian (U.S. PG publication 20160113707) all fail to disclose varying, at one or more locations in the spatial region, a rate at which the carrier member is moved through the spatial region. Paragraph [0027] of the instant disclosure provides a benefit for dynamic electroporation to enable a larger population of cells to be electroporated without increasing the size of the electrodes, without increasing the strength of the electrical field, without using a larger number of electrodes, and potentially in a shorter period of time. The subject matter of the method of claim 6, further comprising: varying, at one or more locations in the spatial region, a rate at which the carrier member is moved through the spatial region could not be found nor was suggested elsewhere in the prior art of record. Accordingly, claim 8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Dependent claim 9 would be allowable by virtue of being dependent upon claim 8.
Conclusion
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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