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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/4/2024 and 7/22/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 16, 22, and 24 are 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 claims 16, 22, and 24, the use of the word “optionally” renders the claims indefinite because of the conditional nature of the term. It is unclear if the applicant’s intention is to require the limitations or merely recite preferred embodiments. For the purposes of this action, the interpretation is that the limitations are preferred embodiments and are not requirements of the claim.
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, 22, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (US 2005/0052630; hereafter Smith).
Regarding claim 1, Smith teaches a device for gene transfer (abstract "An electroporation device which may be used to effectively facilitate the introduction of a macromolecule into cells of a selected tissue in a body"; para [0004] "electroporation, electro- permeabilization, or electrokinetic enhancement has become valuable for gene transfer and DNA vaccination"; para [0023] "The electroporation device and the EKD can be used to electroporate cells and deliver plasmid DNA without causing permanent damage to adjacent cells"), the device comprising: a handpiece (para [0024] "Another aspect of the EKD is the electrode assembly, which preferably includes a non-conductive handle. The electrode handle assembly contains the needle electrode array"); an array of electrodes arranged at one end of the handpiece and configured to be positioned at a host cell of a subject (para [0084] "The electrode disk support structure 102 also has a sterile central injection channel 103 (shown in dotted lines), through which an injection needle may be passed for injection of the macromolecules. The channel 103 preferably extends outward on the top side of the electrode disk 10, through the support structure 102 and handle, to a sufficient length to create a sterile tube that passes through both the handle and disk. Thus, the handle provides a user an easy means for implanting the needle electrodes into a selected tissue and contemporaneously injecting the macromolecules." (see Fig 7.); abstract "An electroporation device which may be used to effectively facilitate the introduction of a macromolecule into cells of a selected tissue in a body"); and a pulse generator configured to generate electric pulses that cause the array of electrodes (para [0084] " The handle preferably houses an electrical connector from the needle electrodes to the pulse generator or EKD") to emit electric fields in the targeted tissue (para [0069] "The present invention pertains to an electro-kinetic device ("EKD") for providing a constant-current electric field through an electrode needle array and facilitating the introduction of a macromolecule into cells of a selected tissue in a body") to maximize expression of a plasmid DNA construct delivered therethrough (para [0003] "Enhancement of plasmid delivery using electroporation allows the injected muscle to be used as a bioreactor for the persistent production and secretion of proteins into the blood stream. The expression levels are increased by as much as two to three orders of magnitude over plasmid injection alone") while minimizing applied voltage and total electrical dose (para [0019] there is also a need to provide a means to effectively control the dosage of electricity delivered to the cells in the inter-electrode space by precisely controlling the ionic flux that impinges on the conduits in the cell membranes"; para [0096] "The EKD is programmable to utilize a variety of electrode pulse patterns. Each pattern may test hypotheses related to providing optimum transgene expression by varying the volume of tissue electroporated, the potential damage associated with current flow in opposite directions through the same tissue volume, and the total current per tissue volume").
In regard to claim 22, Smith discloses wherein the pulse is a perpendicular pulse relative to the orientation of a muscle fiber (functional limitation; the Smith device is capable of meeting this limitation by placing the device in the proper location and adjusting the pulse pattern).
In regard to claim 27, Smith discloses a method of delivering DNA to a subject (see par. [0003]-[0005], [0014], [0023], and [0112]), the method comprising: a. loading the device of claim 1 (see rejection of claim 1) with a plasmid DNA construct encoding a therapeutic protein (see par. [0003]-[0005], [0014], [0023], and [0112]); and b. injecting the DNA plasmid into a host cell, thereby delivering the DNA to the subject (see par. [0003]-[0005], [0014], [0023], and [0112]).
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.
Claim(s) 2-16 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Draghia-Akli et al. (US 2008/0091135 A1; hereinafter Draghia-Akli).
Regarding claim 2, Smith teaches a device for gene transfer comprising a handpiece, electrodes, and means for gene transfer (delivery of DNA), as discussed for claim 1, further comprising a DNA injection port configured to administer the plasmid DNA to the host cell (para [0111] "The electrode disk had a central channel through which the injection needle could be inserted into the muscle, such that the plasmid was delivered within the area that was delineated by the surrounding five electrodes."), wherein the electrode array comprises a first electrode, a second electrode, a third electrode, a fourth electrode, a fifth electrode positioned circumferentially around the DNA injection port (para [0111] "The EKD electroporation device contained a circular array (1 cm diameter) of five equally spaced 21-gauge solid stainless steel needle electrodes").
Smith does not expressly teach a device having six electrodes. However, Draghia-Akli teaches a device for gene transfer comprising circular electrodes, such as 7 electrodes (para [0109] "One aspect of the present invention pertains to the skin EP devices, which enable in vivo electroporation of biomolecules, for example DNA plasmids, into desired skin tissue or skin cells."; para [0105] "methods further include measuring impedance prior to applying the pulse of energy to determine whether electrical contact is made between the desired skin tissue the methods of the invention are used to place at least one DNA vaccine in contact with said intradermic or subcutaneous tissue."; para [0096] "the handle assembly includes a skin electrode array The array can include any number of needle electrodes in one or more different spatial arrangements preferably 7 electrodes or less the needle skin electrode array is circular").
Since Draghia-Akli teaches a device suitable for gene transfer comprising a handle and circular electrodes, that may comprise six electrodes, and Smith teaches a device for gene transfer having five circular electrodes disposed around a DNA injection port, it would have been obvious to an ordinary skilled artisan before the effective filing date of the claimed invention to modify a device taught by Smith having six electrodes, such as to have further options in delivering current pulses to various cells and tissues.
Regarding claims 3 and 4, Smith and Draghia-Akli teach a device for gene transfer comprising a handpiece, electrodes (e.g. six), and means for gene transfer (delivery of DNA), as discussed for claim 2. Smith further teaches that a respective electric pulse generated by the pulse generator travels vertically or diagonally from the first electrode to at least one of the third, fourth, and/or fifth electrodes, or the pulse generator travels vertically or diagonally from the first electrode to at least two of the third, fourth, and/or fifth electrodes (claim 1 "An electro-kinetic device ("EKD") for use in a procedure for electroporation of cells of a selected tissue to facilitate the introduction of macromolecules, comprising an electrode assembly having a plurality of needle electrodes for penetrating the selected tissue; a current waveform generator in electrical communication with the plurality of needle electrodes for applying a constant-current pulse pattern between any plurality of electrodes"; para [0096] "The EKD is programmable to utilize a variety of electrode pulse patterns. Examples of these pulse patterns are illustrated in FIGS. 10-18. Each pattern may test hypotheses related to providing optimum transgene expression by varying the volume of tissue electroporated, the potential damage associated with current flow in opposite directions through the same tissue volume, and the total current per tissue volume"; note that Figs. 10-18 comprise patterns wherein the pulse travels vertically (between adjacent electrodes) or diagonally from the first electrode to at least one of the third, fourth, and/or fifth electrodes (Figs. 10 and 16), and from the first electrode to at least two of the third, fourth, and/or fifth electrodes (see Figs. 10 and 16).
In regard to claims 5-15, the combination teaches the structure and method to accomplish the functional pulses recited in these claims (see para [0096] "The EKD is programmable to utilize a variety of electrode pulse patterns. Examples of these pulse patterns are illustrated in FIGS. 10-18. Each pattern may test hypotheses related to providing optimum transgene expression by varying the volume of tissue electroporated, the potential damage associated with current flow in opposite directions through the same tissue volume, and the total current per tissue volume"; note that Figs. 10-18 comprise patterns wherein the pulse travels vertically (between adjacent electrodes) or diagonally from the first electrode to at least one of the third, fourth, and/or fifth electrodes (Figs. 10 and 16), and from the first electrode to at least two of the third, fourth, and/or fifth electrodes (see Figs. 10 and 16).
Regarding claim 16, Smith and Draghia-Akli teach a device for gene transfer comprising a handpiece, electrodes (e.g. six), and means for gene transfer (delivery of DNA), as discussed for claim 2. Smith further teaches that a respective electric pulse generated by the pulse generator travels vertically from the fourth electrode to the second electrode, or the pulse generator travels diagonally from the fourth electrode to the first electrode (claim 1 "An electro-kinetic device ("EKD") for use in a procedure for electroporation of cells of a selected tissue to facilitate the introduction of macromolecules, comprising an electrode assembly having a plurality of needle electrodes for penetrating the selected tissue; a current waveform generator in electrical communication with the plurality of needle electrodes for applying a constant current pulse pattern between any plurality of electrodes", para [0096] "The EKD is programmable to utilize a variety of electrode pulse patterns. Examples of these pulse patterns are illustrated in FIGS. 10-18. Each pattern may test hypotheses related to providing optimum transgene expression by varying the volume of tissue electroporated, the potential damage associated with current flow in opposite directions through the same tissue volume, and the total current per tissue volume", note that Figs. 10-18 comprise patterns wherein the pulse travels vertically from the fourth electrode to the second electrode (Fig. 13), or diagonally from the fourth electrode to the first electrode (Fig. 12)).
In regard to claim 24, the instant disclosure describes the parameters of distance between the injection needle tip and electrode needle tip as being merely preferable, and does not describe the distance as contributing any unexpected results to the system. As such, parameters such as distance between the injection needle tip and electrode needle tip are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the limitation of the distance between the injection needle tip and electrode needle tip would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
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