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 of Group I, claims 1-24 in the reply filed on May 13, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claims 17-18 are objected to because of the following informalities: In claim 17, “or any combination thereof” should read “and any combination thereof”. In claim 18, “or drugs” should read “and drugs”. Appropriate correction is required.
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 4, 21 and 23-24 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.
Regarding claim 4, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 21 recites the limitation "the mammalian cells" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "an electrical power source" in line 5. However, it is unclear if the electrical power source recited in claim 23 is referring to the electrical power source recited earlier in the claim or is an additional electrical power source.
Claim 23 recites the limitation "an electrical power source couplable to the device" in line 5. The claimed invention is directed to a device and the electrical power source is an element of the claimed device. Thus, it is unclear how the electrical power is coupled to the device (i.e., to itself). It is unclear as to the element of the device the electrical power source should be coupled to.
The term “near” in claim 24 is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claims 1-2, 4, 14-21 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richardson-Burns et al (US 2015/0369771; hereinafter “’771”).
Regarding claims 1-2, ‘771 discloses a device for electroporation or magnetoporation (device of “771 can be used for electroporation or magnetoporation), comprising: a biocompatible scaffold that promotes cellular adhesion to the biocompatible scaffold or cellular association with the biocompatible scaffold or cellular embedding in the biocompatible scaffold (biocompatible polymer encapsulating cells; [0073], [0081]; claim 29); and a distribution of nanoparticles, nanowires, or any combination thereof, wherein the distribution is at least partially encapsulated into the biocompatible scaffold and the nanoparticles or nanowires are either electrically conductive or magnetically responsive or both (biocompatible polymer includes electrically conductive materials; [0046], [0215]-[0219]; claim 40), wherein the distribution of nanoparticles is configured to produce an electric or magnetic field in a physiological solution, media, blood, plasma, serum, extracellular or intercellular fluid, and/or mammalian tissue, for electroporation or magnetoporation, respectively, in response to at least one of the following: a) electrically coupling the distribution to an electrical power source orb) disposing the distribution in an electric or magnetic field ([0013], [0072]-[0073]). Furthermore, it is noted that the recitations of functional language "for electroporation or magnetoporation; to produce an electric or magnetic field in a physiological solution, media, blood, plasma, serum, extracellular or intercellular fluid, and/or mammalian tissue, for electroporation or magnetoporation, respectively" are drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed device and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 4, ‘771 further discloses where the biocompatible scaffold is modified by incorporating ligands such as antibodies or aptamers to enhance the adherence of cells or cell subsets ([0061], [0115]).
Regarding claim 14, the device of ‘771 is structurally the same as the instant device and thus considered to fully capable to “configured to generate an electrical field in response to application of a pulsed magnetic field to the device.”
Regarding claim 15, ‘771 further discloses a delivery material disposed within the biocompatible scaffold, or in the vicinity of the biocompatible scaffold, or in a reservoir attached to the biocompatible scaffold, and configured for delivery to adhered or associated or embedded cells during or after application of the electric or magnetic field using the device ([0061]).
Regarding claim 16, ‘771 further discloses a porous matrix attached to the biocompatible scaffold and configured to act as the reservoir for the delivery material (coating matrix; see [0061], [0072], [0084], [0100]).
Regarding claim 17, ‘771 further discloses wherein the biopolymer comprises biocompatible and biodegradable materials selected from the group consisting of collagen, fibronectin, fibrin, laminin, elastin, hyaluronic acid, chitosan, silk, peptides, biodegradable block copolymers, lactide and glycolide polymers, caprolactone polymers, hydroxybutyric acids, polyanhydrides and polyesters, polyphosphazenes, polyphosphoesters, poly(ethylene glycol) (PEG) and poly(ethylene oxide) (PEO) (including PEG and PEO with different end-functionalities, as well as bifunctional cross-linkers or crosslinking agents), or any combination thereof ([0081], [0216]).
Regarding claim 18, ‘771 further discloses wherein the delivery material is selected from at least one of the following: nucleic acids; proteins; nanoparticles; or drugs ([0061]).
Regarding claim 19, ‘771 further discloses wherein the nanoparticles are selected from the group consisting of carbon-based nanoparticles, metal nanoparticles, metal oxide nanoparticles, ferroelectric nanoparticles, ferromagnetic nanoparticles, piezoelectric nanoparticles, or piezomagnetic nanoparticles ([0046], [0215]-[0219]; claim 40).
Regarding claim 20, ‘771 further discloses wherein additional nanoparticles
selected form the group consisting of ceramic nanoparticles, semiconductor nanoparticles,
polymeric nanoparticles, lipid nanoparticles, silica nanoparticles, exosomes, leukosomes, or
aposomes ([0046], claim 40).
Regarding claim 21, the device of ‘771 is structurally the same as the instant device and thus considered to fully capable to “to facilitate flow through the biocompatible scaffold of the blood, plasma, serum, extracellular fluid, buffer or medium in which the mammalian cells or extracellular vesicles are placed.” See also [0051].
Regarding claim 23, ‘771 further discloses an electrode; and an electrical power source couplable to the device and the electrode to generate an
electrical field between the device and the electrode ([0011], [0013], [0046]).
Therefore, ‘771 meets and anticipates the limitations set forth in claims 1-2, 4, 14-21 and 23.
Claims 1, 3, 6-10, 12, 14 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paukshto et al (already of record, US 2012/0065703; hereinafter “Paukshto”).
Regarding claim 1, Paukshto discloses device for electroporation or magnetoporation, comprising: a biocompatible scaffold that promotes cellular adhesion to the biocompatible scaffold or cellular association with the biocompatible scaffold or cellular embedding in the biocompatible scaffold (FIGS. 1-3 and 6: cells associated with biocompatible polymer; [0027], [0031], [0035], [0038]-[0039], [0057]); and a distribution of nanoparticles, nanowires, or any combination thereof, wherein the distribution is at least partially encapsulated into the biocompatible scaffold and the nanoparticles or nanowires are either electrically conductive or magnetically responsive or both (FIGS. 2-3: a network of nanowire network encapsulated in the biocompatible polymer; [0043]-[0046], claim 18), wherein the distribution of nanoparticles is configured to produce an electric or magnetic field in a physiological solution, media, blood, plasma, serum, extracellular or intercellular fluid, and/or mammalian tissue, for electroporation or magnetoporation, respectively, in response to at least one of the following: a) electrically coupling the distribution to an electrical power source or b) disposing the distribution in an electric or magnetic field (nanowire network can be employed to produce magnetic field; see [0019], [0031], [0052]). Furthermore, it is noted that the recitations of functional language "for electroporation or magnetoporation; to produce an electric or magnetic field in a physiological solution, media, blood, plasma, serum, extracellular or intercellular fluid, and/or mammalian tissue, for electroporation or magnetoporation, respectively" are drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed device and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 3, Paukshto discloses wherein the biocompatible scaffold comprises an aligned collagen membrane (see FIGS. 2 and 6A-6B; [007],[0018], [0027]).
Regarding claim 6, Paukshto discloses wherein the distribution of nanoparticles comprises a conductive nanowire network ([0008]-[0009]).
Regarding claim 7, Paukshto discloses wherein the conductive nanowire network does not have any closed loops of connected nanowires with a diameter of more than 200 micrometers that does not have nanowires inside the loop (closed loop of nanowire network having a loop spacing of 0.01 micrometers; see [0046]-[0047] and FIG. 3).
Regarding claim 8, Paukshto discloses wherein the conductive nanowire network does not have any closed loops of connected nanowires with a Feret's diameter of more than 100 micrometers in at least one direction (closed loop of nanowire network having a loop spacing of 0.01 micrometers; see [0046]-[0047] and FIG. 3).
Regarding claim 9, the device of ‘771 is structurally the same as the instant device and thus considered to fully capable to be coupled to an electrical power source. See also [0019] and [0044].
Regarding claim 10, the device of ‘771 is structurally the same as the instant device and thus considered to fully capable to be coupled to an electrical power source. See also [0019] and [0044]. ‘771 further discloses wherein the conductive nanowire network comprises a first nanowire network and a second nanowire network (see FIG. 2: upper layer (202) comprising nanowire network and a bottom layer (204) comprising nanowire network; [0043]).
Regarding claim 12, Paukshto discloses wherein the conductive nanowire network has a resistance between 1-10,000 ohm/sq ([0050]).
Regarding claim 14, Paukshto discloses wherein the device is configured to generate an electrical field in response to application of a pulsed magnetic field to the device ([0016], [0019]).
Regarding claim 24, Paukshto discloses wherein a magnetic field source configured for placement near the device and for generating a magnetic field that results in the device generating an electrical field or magnetic field in response to the magnetic field generated by the magnetic field source (see [0017], [002+], [0055]). Furthermore, the limitation “for generating a magnetic field that results in the device generating an electrical field or magnetic field in response to the magnetic field generated by the magnetic field source” is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114).
Therefore, Paukshto meets and anticipates the limitations set forth in claims 1, 3, 6-10, 12, 14 and 24.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Paukshto as applied to claim 1 above.
Regarding claim 13, Paukshto disclose the device according to claim 1 as set forth above. Paukshto discloses a distance from any point of the biocompatible scaffold to a nearest one of nanoparticles or nanowires (FIGS. 2-3), but does not explicitly disclose wherein the distance is no more than 100 micrometers. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distance from any point of the biocompatible scaffold to a nearest one of nanoparticles or nanowires in order to optimize application of magnetic field on biological materials according to need. Furthermore, it’s noted that the courts have held where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 IV. A.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Paukshto as applied to claim 1 above, and further in view of Franke et al (already of record, US 2020/0188660; hereinafter “Franke”).
Regarding claim 5, Paukshto discloses the device according to claim 1. Paukshto does not explicitly disclose wherein the distribution of nanoparticles comprises nanowires above the percolation threshold. Franke in related art of electrode cured and manufactured in the body, and related methods and devices, further discloses wherein nanowires above the percolation threshold ([0890]- the metallic elements (less than 5 microns diameter) are added above their percolation threshold; [0283]- 0.5 g gold nanowires). In view of Franke, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the nanowires of Paukshto with the nanowires of Franke such that the nanowires are above the percolation threshold. One of ordinary skill in the art would have made said modification in order to a biocompatible electrode which can be injected in bodily tissue and reduce costs (see Franke at [0012]; there is therefore a need for a biocompatible electrode which can be injected, cured and molded to surround and conform to the contours of a target in or on bodily tissue in a minimally invasive or external procedure, and produce far better chronic results at the interface with the target in bodily tissue; [0894]- Advantages of the magnetically conductive cured electrode include that they are a low Cost and Effective Conductive Filler).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Paukshto as applied to claim 10 above.
Regarding claim 11, Paukshto disclose the device according to claim 10 as set forth above. Paukshto discloses a distance from a point of the first nanowire network to a nearest point of the second nanowire network (FIG. 2), but does not explicitly disclose wherein the distance is no more than 100 micrometers. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distance between the first and second nanowire networks to have the claimed distance in order to optimize application of magnetic field on biological materials according to need. Furthermore, it’s noted that the courts have held where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 IV. A.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Paukshto as applied to claim 1 above, and further in view of Mickelsen (already of record, US 2018/0042674) and Wang et al (already of record, US 2019/0381324; hereinafter “Wang”).
Regarding claim 22, Paukshto discloses the device according to claim 1. Paukshto discloses wherein the distribution comprises of nanoparticles or nanowires are made from two or more materials, (see [0008]). Paukshto fails to discloses a device for electroporation; when in contact with an ionic fluid, are configured to produce an ionic current to facilitate or enhance electroporation. Mickelsen in related art of methods and apparatus for selective tissue ablation, discloses a device for electroporation ([0002]- The embodiments described herein relate generally to medical devices ... generate irreversible electroporation of cell membranes); when in contact with an ionic fluid, are configured to produce an ionic current to facilitate or enhance electroporation ([0102]- irreversible electroporation through ionic fluid irrigation; [0002]- medical devices ... the application of suitably timed pulsed voltages that generate irreversible electroporation of cell membranes). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device for electroporation and when in contact with an ionic fluid, are configured to produce an ionic current to facilitate or enhance electroporation of Mickelsen, with the device of Paukshto, to provide improved systems and methods for the selective and rapid application of DC voltage to drive electroporation (see Mickelsen, [0005]- There is a need for selective energy delivery for electroporation and its modulation in various tissue types ... There is also a need for more effective generation of voltage pulses and control methods; para [0006]- Catheter systems and methods are disclosed for the selective and rapid application of DC voltage to drive electroporation). Further, Wang in related art of self-powered, auto-responsive implanted vagal nerve stimulator, further discloses two or more materials, each having a different electron affinity ([0044]- the two materials have opposite electron affinity); the materials with different electron affinity (para [0044]- the two materials have opposite electron affinity). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the materials with different electron affinity of Wang, with the device of Paukshto, to provide an improved stimulator for energy conversion (see Wang, [0005]- Solutions for selectively transmitting electrical stimulation to the vagal nerve on a set schedule have had their shortcomings because the complex circuitry required to elicit pre-scheduled electrical stimulation requires large amounts of battery power and cannot accurately predict the timing of users' food intake; [0006]- The present invention provides an implantable vagal nerve stimulator having a "passive" power generator that harvests energy from the stomach's movements to transform that kinetic energy to electrical energy eliminating the need for a battery).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Alden et al (US 2008/0286447) (FIGS. 10A-10E); Paukshto et al (US 2014/0081070) (FIGS. 9A-9B).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
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