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 .
Claim Rejections - 35 USC § 102
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.
Claim(s) 1 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eckwright et al (US 2018/0140832).
Regarding claim 1, Eckwright discloses an electroporation probe (title; figs 1-6) comprising: a hollow tubular probe (¶34) having a proximal end (fig 2), a distal end (fig 3) and a plurality of perforations 54 towards the distal end of the probe (fig 3), said perforations connecting the hollow interior of said probe with its exterior (¶35), said proximal end being connected to a fluid injector 500 (fig 11; ¶34) and said distal end further including a tip (fig 3); a tubular movable sleeve 42 covering at least a partial length of the probe, said sleeve being slidable longitudinally along the outer surface of the probe between a first position sealing each of said perforations (fig 6) and a second position unsealing each of said perforations (fig 3), a distal end of said movable sleeve being connected to first terminal of a power source 490 (via 38, ¶32) and said tip of said probe being connected to a second terminal of the power source 490 (via 28, ¶31) for generation of an electroporation electric field between said tip and said distal end of said movable sleeve (¶49); and a probe holder (access device or probe in ¶32) having an interior channel wherein said tubular movable sleeve extends through the interior channel (¶32), and a sliding tab 35 attached to the tubular sleeve such that a longitudinal movement of the sliding tab away from the tip of the probe causes the movable sleeve to move from the first position towards the second position (figs 5 and 6 being first position and figs 1-3 being second position).
Regarding claim 10, Eckwright discloses a method of providing electroporation and a medicinal solution at a target site, said method comprising: placing a tip 58 (fig 3), said tip being at a distal end of a hollow tubular probe (fig 3; ¶64), and a distal end 48 of a tubular movable sleeve 42 covering at least a partial length of said probe on a target site (fig 3), said hollow tubular probe having a proximal end (fig 2), and a plurality of perforations 54 (fig 3) towards the distal end, said perforations connecting the hollow interior of said probe with its exterior (¶35), said proximal end being connected to a fluid injector 500 (fig 11; ¶34), said tubular movable sleeve being slidable longitudinally along the outer surface of the probe between a first position (fig 6) sealing each of said perforations and a second position (fig 3) unsealing each of said perforations; achieving a desired separation between said distal end of said movable sleeve and said tip by sliding said movable sleeve (fig 3 vs fig 6) using a sliding tab 35 attached to the tubular sleeve (fig 2) such that a longitudinal movement of the sliding tab away from the tip of the probe causes said movable sleeve to slide from the first position towards the second position (figs 5 and 6 vs figs 1-3), said sliding tab being included in a probe holder (access device or probe in ¶32) having an interior channel wherein said tubular movable sleeve extends through the interior channel (¶32); and performing at least one of the following steps: i) enabling an electrical connection between a first electrical conductor lead connected to said distal end of said movable sleeve with a first terminal of a power source and, enabling an electrical connection between a second electrical conductor lead connected to said tip of said probe with a second terminal of the power source for generation of an electroporation electric field between said tip and said distal end of said movable sleeve (see field generated in fig 3); and ii) delivering a medicinal solution to the target site by injecting said medicinal solution into the probe, for being ejected from unsealed perforations on the probe, through the fluid injector (¶35).
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.
Claim(s) 2, 3, 8, 9, 11, 12 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eckwright et al (US 2018/0140832) in view of Atanasoska et al (US 2011/0270152).
Regarding claims 2 and 11, while Eckwright substantially discloses the invention as claimed, it does not disclose wherein said power source is a DC battery.
Atanasoska discloses an electroporation device which also delivers therapeutic agent (¶63) which uses a DC battery as a power source (¶64).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Eckwright such that the power source is a DC battery as taught by Atanasoska as it is a known power source type in electroporation devices with every expectation of success.
Regarding claims 3 and 12, while Eckwright substantially discloses the invention as claimed, it does not disclose said first terminal is a cathode terminal of said DC battery and the second terminal is an anode terminal of said DC battery.
As addressed above, Atanasoska discloses use of a DC battery. Further it requires routine skill in the art via routine experimentation (especially as there are only two choices) to determine to which terminals to connect the electrodes.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to determine through routine experimentation which of the terminal should be the cathode and which should be the anode to deliver the fluid as desired.
Regarding claims 8, 9, 17 and 18, while Eckwright substantially discloses the invention as claimed, it does not disclose said distal end of said movable sleeve is connected to first terminal of the power source through a switch, nor said tip of said probe is connected to the second terminal of the power source through a switch.
Atanasoska discloses use of a switch to operate the device to be on/off (¶64). One of ordinary skill in the art recognizes that in its most primitive form, an on/off switch is used to complete an electrical circuit to the turn the device on or interrupt the electrical circuit to turn the device off. One of ordinary skill in the art would also recognize that placement of said on/off switch requires routine skill so long as it can be used to complete/interrupt said electrical circuit.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Eckwright such said distal end of said movable sleeve is connected to (the) first terminal of the power source through a switch and/or said tip of said probe is connected to the second terminal of the power source through a switch as suggested by Atanasoska to allow a user to turn the device on/off.
Regarding claim 19, while Eckwright substantially discloses the invention as claimed, it does not explicitly disclose said medicinal solution includes one or more of a drug, antibodies, protein and cells.
Eckwright discloses “genomic therapy” which may comprise the claimed substances, but no necessarily.
Atanasoska discloses using electroporation to drive a drug into a subject (¶5).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Eckwright such said medicinal solution includes one or more of a drug, antibodies, protein and cells as taught by Atanasoska to give the device the ability to treat a wider range of diseases.
Claim(s) 4, 5, 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eckwright et al (US 2018/0140832) in view of Taff et al (US 2024/0206937).
Regarding claims 4 and 13, while Eckwright substantially discloses the invention as claimed, it does not disclose wherein said tip is metallic and tapered.
Taff shows a tapered tip 16 which is used for tissue-piercing (¶286).
Neither Eckwright nor Taff explicitly discloses the material of the tip. However, Taff teaches using the tip for tissue-piercing and one of ordinary skill in the art would appreciate that metals are one known material used for tissue piercing.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Eckwright such that the tip is metallic and tapered as suggested by Taff to allow for tissue-piercing with the device and since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claims 5 and 14, while Eckwright substantially discloses the invention as claimed, it does not explicitly disclose wherein the hollow tubular probe and the tubular movable sleeve are flexible.
Taff discloses its shaft 1 may be flexible (¶286).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Eckwright such that the hollow tubular probe and the tubular movable sleeve are flexible as taught by Taff to allow a user to navigate tortuous anatomy with the device to reach a desired treatment location.
Claim(s) 6, 7, 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eckwright et al (US 2018/0140832) in view of Ward et al (US 2021/0077136).
Regarding claims 6, 7, 15 and 16, while Eckwright substantially discloses the invention as claimed, it does not disclose movement of said sliding tab away from the tip of said probe is resisted by a compression spring, nor the compression spring is included in said probe holder.
Ward discloses a handle for an electrosurgical device (¶27) which utilizes a compression spring 54 to bias the device into a position (¶51). When viewing Eckwright in view of Ward, one would appreciate that biasing Eckwright into the closed/first position for delivery would help prevent unintentional movement into the operational/second.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Eckwright such that movement of said sliding tab away from the tip of said probe is resisted by a compression spring, and the compression spring is included in said probe holder as suggested by Ward to assist in preventing unintentional movement into the operational state during device placement.
Response to Arguments
Applicant has overcome the claim objections and 112 rejections.
Applicant argues Eckwright does not have “a sliding tab attached to the tubular sleeve such that a longitudinal movement of the sliding tab away from the tip of the probe causes the movable sleeve to move from the first position towards the second position...”. More specifically the sliding tab 35 is not connected with the sliding tubes 40 or 42 and does not retract them. The examiner disagrees. Eckwright shows how they are connected in fig 2 and ¶32 specifically states that “outer tubular member 42 translates and/or rotates with the distal handle 32...”. In the same paragraph (¶32) Eckwright states “distal handle 32 includes a neck 34...” and “The neck 34 may include a tab 35...”. Thus sliding tab 35 is connected to sliding tube 42 and translates said tube (including retraction as claimed).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
Prosecution Insights