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 statement (IDS) submitted on August 21, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on May 29, 2024 and August 09, 2024 are accepted.
Claim Objections
Claim 4 is objected to because of the following informalities:
In claim 4, the term “the microcapsules” at the end of the claim should be corrected to –the at least two microcapsules--.
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.
Claim 13 is 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 pre-AIA the applicant regards as the invention.
Claim 13 recites “surface damage or cytotoxicity” that renders the scope of the claim indefinite. In regard to “surface damage”, it is unclear what surface it refers to”. In regard to “cytotoxicity”, since there is no preceding recitation that is related to a cell, it is unclear what this cytotoxicity refers to.
The dependent claims of the above rejected claims are rejected due to their dependency.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman et al., US 2021/0220480 A1, hereinafter Peyman, in view of Baxter et al., US 2022/0008347 A1, hereinafter Baxter, further in view of Zhang et al., US 2020/0131556 A1, hereinafter Zhang.
Claim 1. Peyman teaches a system for delivering a therapeutic agent comprising:
at least one microcapsule, including the therapeutic agent and a layer of iron oxide nanoparticles (IONPs), wherein the therapeutic agent is encapsulated by the layer of the IONPs ([0096]: the antibody coated pluralities of nanoparticles or liposomes with activatable cell-penetrating peptides (ACPPs) are selected from…silica iron oxide nanoshells; and [0191]: a combination of nanoparticles with activatable cell-penetrating peptides (ACPPs) is used to have additional functionalities as well as imaging, thermoacoustic imaging for thermotherapy and imaging and tumor therapy by administering to a patient systemically or locally…antibody coated perfluorohexane (PFH)-loaded magnetic hollow iron oxide nanoparticles (HIONs) and Fe-O stretching vibration mode of Fe3O4T…and iron oxide coating nanocapsules that absorb thermal delivery using alternating magnetic field; and [0201]: one achieves a theranostic or diagnostic and therapeutic effect when the antibody coated plurality of nanoparticles with ACPPs conjugated with a Wnt inhibitor, such as ivermectin, a Rock inhibitor, small molecule inhibitors, anti-inflammatory agent, are encapsulated in the antibody coated liposomes or antibody coated nanoparticles) – either a microcapsule as claimed or a nanocapsule taught by Penman is considered a material with an encapsulating configuration that comes in small sizes, wherein
the layer of the IONPs comprises a first type of nanoparticles and a second type of nanoparticles ([0175]: the thermal output of the thermal energy delivery system is an electromagnetic radiation which heats up the tissue located at the focal point…or other electromagnetic radiation using an antibody/medication coated agent such as…nanoshells nanocage magnetic, gold, silicone, carbon, mixture of magnetic NPs); and
a magnetic system configured to generate a magnetic field to control a motion of the at least one microcapsule ([0054]: the heating source is an alternating magnetic field; and [0055]: the alternating magnet has high frequency…so that the thermal energy is proportional to the frequency of the magnetic field and the mechanical rotation of the nanoparticles) – rotation is a type of motion.
In regard to the recited feature of “a microcapsule”, as considered above, it is considered a capsule that comes in small sizes. However, if Peyman is considered not providing sufficient teaching to this feature, in an analogous nanoparticle-based biomaterial field of endeavor, Baxter teaches
at least one microcapsule, including the therapeutic agent and a layer of iron oxide nanoparticles (IONPs), wherein the therapeutic agent is encapsulated by the layer of the IONPs ([0004]: self-assembled microcapsules, functionalized with organic ligands which undergo electron transfer upon activation with one or more external stimulus, are provided. Compositions and kits that include the microcapsules, as well as methods of delivering one or more substrate encapsulated inside the microcapsules to an individual, are also provided. This structures, compositions and methods find use in a variety of applications, such as drug and cell encapsulation technologies, for direct delivery, control, and activation of medicines and therapies to specific tissue in a living host; [0005]: a self-assembled microcapsule composed of nanoparticles; [0049]: the nanoparticles are composed of a material selected from…a metal oxide…silica coated iron oxide nanoparticles; and [0105]: the nanoparticles are arranged in one or more layers to form the microcapsule. The composition of each layer of the microcapsule may be the same or may be different); and
the layer of the IONPs comprises a first type of nanoparticles and a second type of nanoparticles ([0103]: mixtures of different sizes and/or shapes of nanoparticles may be included in the three-dimensional structures as desired. In other embodiments, the nanoparticles have substantially the same size and shape; and [0104]: nanoparticles may be composed of materials, such as…iron oxide…silica coated iron oxide; and [0105]: the nanoparticles are arranged in one or more layers to form the microcapsule. The composition of each layer of the microcapsule may be the same or may be different).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system of Peyman employ such a feature associated with the microcapsule as taught in Baxter for the advantage of “direct delivery, control, and activation of medicines and therapies to specific tissues in a living host”, as suggested in Baxter, [0004].
In regard to the feature of the magnetic system being configured to generate a magnetic field to control a motion of the at least one microcapsule, Peyman teaches using an alternate magnetic field to cause a rotation of the nanoparticle. Peyman does not teach that the magnetic field causes and controls a motion of the at least one microcapsule.
However, in an analogous magnetic-nanoparticle based material control and utility field of endeavor, Zhang teaches
a magnetic system being configured to generate a magnetic field to control a motion of the at least one microcapsule ([0037]: the microrobots are capable of movement in a controlled manner and offer capabilities as a biomarker and motion detection of target molecule in a fluid. The disclosed micro-/nanomaterials and engineered microstructures may also be referred to as magnetic spores…steerable microrobots, and magnetic micromachines; [0042]: a functionalized microrobot 110 can controllably move in a fluid by a magnetic field generator with a motion control system 120; [0043]: functionalized microrobots can be prepared by initially depositing magnetic coating onto pretreated bio-templates…The magnetic coating can enable actuation and navigation of the microrobots…An example fabrication technique includes three steps, for example, depositing Fe2O4 nanoparticles…, modifying the deposited Fe3O4…, and conjugating with oligosaccharide-functionalized fluorescent carbon dots…The disclosed deposition technique can be implemented to produce magnetically-propelled functionalized microrobots).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system of Peyman and Baxter combined employ such a feature associated with “a magnetic system being configured to generate a magnetic field to control a motion of the at least one microcapsule” as taught in Zhang for the advantage of “developing a simple, rapid, and real-time-monitoring diagnostic approach for clinical needs and helpful to the clinician for the prescription of an efficient treatment”, as suggested in Baxter, [0002].
Claim 2. Peyman further teaches
release the therapeutic agent at a target region ([0028]: a cancer treatment method using controlled localized thermotherapy. The method comprises the steps of (i) administering a plurality of nanoparticles to a patient in need thereof so as to target a tumor in the patient, the administered nanoparticles being coated with an antitumor antibody…a gene and a drug…; (ii) heating the nanoparticles…so as to damage one or more tumor cell membranes at a treatment site of the tumor).
Claim 3. Baxter further teaches that
the microcapsule has an asymmetric structure, wherein the microcapsule with the asymmetric structure comprises the layer of IONPS, where the IONPs are concentrated at a portion of the layer ([0103]: mixtures of different sizes and/or shapes of nanoparticles may be included in the three-dimensional structures as desired. In other embodiments, the nanoparticles have substantially the same size and shape; and [0104]: nanoparticles may be composed of materials, such as…iron oxide…silica coated iron oxide).
Since the self-assembled microcapsules is composed of nanoparticle mixtures of iron oxide and silica coated iron oxide, at the portion where the iron oxide is deposited, it carries a higher concentration of iron oxide than the portion where the silica coated iron oxide is deposited due to the presence of the silica. The structure hence is considered “asymmetric” as claimed.
Claims 4-5. Baxter further teaches that
at least two microcapsules form a robotic assembly chain by coupling the microcapsules ([0102]: the nanoparticles are stably associated with each other through non-covalent interaction, such as, but not limited to…hydrogen bonds, van der Walls forces, dipole-dipole interactions…and the like; and [0105]: the nanoparticles are arranged in one or more layers to form the microcapsule. The composition of each layer of the microcapsule may be the same or may be different…a layer of microcapsule may have a different composition than an adjacent layer…that may differ…in composition, organic ligand attached to the surface of the nanoparticle, and the like).
Dipole-dipole interaction is an intramolecular interaction that occurs when the molecule have uneven or asymmetric charge distribution. For the microcapsules that are composed of mixture nanoparticles that differ in composition and/or the functionalization group, dipole-dipole interaction exists between these nanoparticles, including the nanoparticles within the same microcapsule and the nanoparticles of adjacent or nearby microcapsules. Dipole-dipole interaction between nanoparticles of adjacent or nearby microcapsules is a coupling mechanism that link two or more adjacent or nearby microcapsules, and it is considered the “robotic assembly chain” as claimed.
Claim 6. In regard to the claimed feature of “the robotic assembly chain is configured to crawl over a physical barrier to reach a target region”, it is considered an intended use of the claimed system. Such a limitation does not further limit the structure of the claimed device. There is no recitation in the claim what structural limitation causes the robotic assembly chain to crawl over a physical barrier. As Zhang teaches in [0049]: microrobots may have locomotion caused by the magnetic field in three motion modes, spinning, rotation-translation, and tumble, as illustrate in FIG.5, it is considered reading on the above identified limitation. For the above consideration, see MPEP § 2114.II: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claim 7. Baxter further teaches that
a diameter of the microcapsule ranges between about 10 µm to about 1000 µm ([0100]: By “microcapsule” or “microcapsule configuration” is meant the structure has a size range in the micrometer (µm) scale. For example, a microstructure may have a size (e.g., largest dimension) of 100 µm or less, such as a size ranging from 0,1 µm to 100 µm).
Claim 8. Baxter further teaches that
the microcapsule is configured to contain the therapeutic agent more than about 73.00% of the microcapsule volume ([0100]: By “microcapsule” or “microcapsule configuration” is meant the structure has a size range in the micrometer (µm) scale. For example, a microstructure may have a size (e.g., largest dimension) of 100 µm or less, such as a size ranging from 0,1 µm to 100 µm…the microcapsule has a thickness of from 1% to 50% of the volume of the microcapsule, such as…1% to 20%, or 1% to 10%. By “thickness” it meant the thickness of the shell).
As the size of Baxter refers to the largest dimension, for the ease of calculation the volume, assuming that the microcapsule is spherical, the volume is directly proportional to the cubic of the radius. When the thickness is 10% or less, the payload volume of the microcapsule is more than 73%.
Claim 9. Zhang further teaches that
a thickness of the layer ranges from about 10 nm to about 10 µm ([0043]: the magnetic coating layer may leave a thickness between 50 nm and 200 nm).
Claim 10. Peyman further teaches that
the therapeutic agent is a water-based therapeutic agent or an oil-based therapeutic agent ([0201]: one achieves a theranostic or diagnostic and therapeutic effect when the antibody coated plurality of nanoparticles with ACPPs conjugated with a Wnt inhibitor, such as ivermectin, a Rock inhibitor, small molecule inhibitors, anti-inflammatory agent, are encapsulated in the antibody coated liposomes or antibody coated nanoparticles) – ivermectin is highly fat-soluble, hence an oil-based molecule.
Claim 11. Zhang further teaches that
the motion comprises rolling, walking, kayaking, spinning, or combinations thereof ([0049]: microrobots may have locomotion caused by the magnetic field in three motion modes, spinning, rotation-translation, and tumble, as illustrate in FIG.5).
Claim 12. The system of claim 1, wherein
the first type of the nanoparticles is SiO2 nanoparticle and the second type of nanoparticles is Fe3O4 nanoparticle ([0103]: mixtures of different sizes and/or shapes of nanoparticles may be included in the three-dimensional structures as desired. In other embodiments, the nanoparticles have substantially the same size and shape; and [0104]: nanoparticles may be composed of materials, such as…iron oxide…silica coated iron oxide) – silica is a compound composed of SiO2.
Claim 13. Peyman further teaches
deliver the therapeutic agent without causing surface damages or cytotoxicity ([0096]: the antibody coated pluralities of nanoparticles or liposomes with activatable cell-penetrating peptides (ACPPs)).
ACPPs are short positively charged peptides that facilitate the cellular uptake of molecules by interacting with negatively charged cell-surface molecules that does not cause surface damages.
Claim 14. Peyman teaches a method of delivering a therapeutic agent comprising:
introducing at least one microcapsule to a subject ([0028]: administering a plurality of nanoparticles to a patient in need thereof so as to target a tumor in the patient), wherein
the microcapsule comprises the therapeutic agent and a layer of iron oxide nanoparticles (IONPs), wherein the therapeutic agent is encapsulated by the layer of the IONPs ([0096]: the antibody coated pluralities of nanoparticles or liposomes with activatable cell-penetrating peptides (ACPPs) are selected from…silica iron oxide nanoshells; and [0191]: a combination of nanoparticles with activatable cell-penetrating peptides (ACPPs) is used to have additional functionalities as well as imaging, thermoacoustic imaging for thermotherapy and imaging and tumor therapy by administering to a patient systemically or locally…antibody coated perfluorohexane (PFH)-loaded magnetic hollow iron oxide nanoparticles (HIONs) and Fe-O stretching vibration mode of Fe3O4T…and iron oxide coating nanocapsules that absorb thermal delivery using alternating magnetic field; and [0201]: one achieves a theranostic or diagnostic and therapeutic effect when the antibody coated plurality of nanoparticles with ACPPs conjugated with a Wnt inhibitor, such as ivermectin, a Rock inhibitor, small molecule inhibitors, anti-inflammatory agent, are encapsulated in the antibody coated liposomes or antibody coated nanoparticles) – either a microcapsule as claimed or a nanocapsule taught by Penman is considered a material with an encapsulating configuration that comes in small sizes, wherein
the layer of the IONPs comprises a first type of nanoparticles and a second type of nanoparticles ([0175]: the thermal output of the thermal energy delivery system is an electromagnetic radiation which heats up the tissue located at the focal point…or other electromagnetic radiation using an antibody/medication coated agent such as…nanoshells nanocage magnetic, gold, silicone, carbon, mixture of magnetic NPs) ;
directing the at least one microcapsule to a target area using a magnetic system, wherein the magnetic system is configured to generate a magnetic field to control a motion of the at least one microcapsule ([0054]: the heating source is an alternating magnetic field; and [0055]: the alternating magnet has high frequency…so that the thermal energy is proportional to the frequency of the magnetic field and the mechanical rotation of the nanoparticles) – rotation is a type of motion e; and
disrupting the at least one microcapsule for releasing the therapeutic agent at the target area ([0029]: heating the nanoparticles with an energy source…thereby releasing the fluorescein or doxorubicin into the circulation of the patient).
In regard to the recited feature of “a microcapsule”, as considered above, it is considered a capsule that comes in small sizes. However, if Peyman is considered not providing sufficient teaching to this feature, in an analogous nanoparticle-based biomaterial field of endeavor, Baxter teaches
at least one microcapsule, including the therapeutic agent and a layer of iron oxide nanoparticles (IONPs), wherein the therapeutic agent is encapsulated by the layer of the IONPs ([0004]: self-assembled microcapsules, functionalized with organic ligands which undergo electron transfer upon activation with one or more external stimulus, are provided. Compositions and kits that include the microcapsules, as well as methods of delivering one or more substrate encapsulated inside the microcapsules to an individual, are also provided. This structures, compositions and methods find use in a variety of applications, such as drug and cell encapsulation technologies, for direct delivery, control, and activation of medicines and therapies to specific tissue in a living host; [0005]: a self-assembled microcapsule composed of nanoparticles; [0049]: the nanoparticles are composed of a material selected from…a metal oxide…silica coated iron oxide nanoparticles); and
the layer of the IONPs comprises a first type of nanoparticles and a second type of nanoparticles ([0103]: mixtures of different sizes and/or shapes of nanoparticles may be included in the three-dimensional structures as desired. In other embodiments, the nanoparticles have substantially the same size and shape; and [0104]: nanoparticles may be composed of materials, such as…iron oxide…silica coated iron oxide).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system of Peyman employ such a feature associated with the microcapsule as taught in Baxter for the advantage of “direct delivery, control, and activation of medicines and therapies to specific tissues in a living host”, as suggested in Baxter, [0004].
In regard to the feature of the magnetic system being configured to generate a magnetic field to control a motion of the at least one microcapsule, Peyman teaches using an alternate magnetic field to cause a rotation of the nanoparticle. Peyman does not teach that the magnetic field causes and controls a motion of the at least one microcapsule.
However, in an analogous magnetic-nanoparticle based material control and utility field of endeavor, Zhang teaches
a magnetic system being configured to generate a magnetic field to control a motion of the at least one microcapsule ([0037]: the microrobots are capable of movement in a controlled manner and offer capabilities as a biomarker and motion detection of target molecule in a fluid. The disclosed micro-/nanomaterials and engineered microstructures may also be referred to as magnetic spores…steerable microrobots, and magnetic micromachines; [0042]: a functionalized microrobot 110 can controllably move in a fluid by a magnetic field generator with a motion control system 120; [0043]: functionalized microrobots can be prepared by initially depositing magnetic coating onto pretreated bio-templates…The magnetic coating can enable actuation and navigation of the microrobots…An example fabrication technique includes three steps, for example, depositing Fe2O4 nanoparticles…, modifying the deposited Fe3O4…, and conjugating with oligosaccharide-functionalized fluorescent carbon dots…The disclosed deposition technique can be implemented to produce magnetically-propelled functionalized microrobots).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system of Peyman and Baxter combined employ such a feature associated with “a magnetic system being configured to generate a magnetic field to control a motion of the at least one microcapsule” as taught in Zhang for the advantage of “developing a simple, rapid, and real-time-monitoring diagnostic approach for clinical needs and helpful to the clinician for the prescription of an efficient treatment”, as suggested in Baxter, [0002].
Claim 15. In regard to the claimed feature of “introducing the therapeutic agent before or after the microcapsule is formed”, when constructing a therapeutic agent encapsulated microcapsule, the therapeutic agent would be introduced prior to the formation of the microcapsule, at the same time mixed with the raw materials for forming the microcapsule, or after the microcapsule is formed. For the situation that the therapeutic agent is introduced at the same time, i.e., mixed with the raw materials for forming the microcapsule, it is considered that the therapeutic agent is introduced prior to the formation of the microcapsule since at the time that the therapeutic agent is introduced, there presents only the raw material.
Hence for either of the three possible situations it reads on the claimed feature of introducing the therapeutic agent “before or after the microcapsule is formed”.
Claims 16-17. Baxter further teaches that
at least two microcapsules form a robotic assembly chain by coupling the microcapsules ([0102]: the nanoparticles are stably associated with each other through non-covalent interaction, such as, but not limited to…hydrogen bonds, van der Walls forces, dipole-dipole interactions…and the like; and [0105]: the nanoparticles are arranged in one or more layers to form the microcapsule. The composition of each layer of the microcapsule may be the same or may be different…a layer of microcapsule may have a different composition than an adjacent layer…that may differ…in composition, organic ligand attached to the surface of the nanoparticle, and the like).
Dipole-dipole interaction is an intramolecular interaction that occurs when the molecule have uneven or asymmetric charge distribution. For the microcapsules that are composed of mixture nanoparticles that differ in composition and/or the functionalization group, dipole-dipole interaction exists between these nanoparticles, including the nanoparticles within the same microcapsule and the nanoparticles of adjacent or nearby microcapsules. Dipole-dipole interaction between nanoparticles of adjacent or nearby microcapsules is a coupling mechanism that link two or more adjacent or nearby microcapsules, and it is considered the “robotic assembly chain” as claimed.
Claim 18. Zhang further teaches that
the motion comprises rolling, walking, kayaking, spinning, or combinations thereof ([0049]: microrobots may have locomotion caused by the magnetic field in three motion modes, spinning, rotation-translation, and tumble, as illustrate in FIG.5).
Claim 19. Peyman further teaches
delivering the therapeutic agent to the target area without damages or cytotoxicity ([0096]: the antibody coated pluralities of nanoparticles or liposomes with activatable cell-penetrating peptides (ACPPs).
ACPPs are short positively charged peptides that facilitate the cellular uptake of molecules by interacting with negatively charged cell-surface molecules that does not cause surface damages.
Claim 20. Peyman further teaches
a structure of the microcapsule is disturbed at a target region by a physical force, a thermal energy, or a magnetic force ([0029]: heating the nanoparticles with an energy source…thereby releasing the fluorescein or doxorubicin into the circulation of the patient).
Claim 22. Baxter further teaches
accumulating at least two microcapsules to the target area to increase a drug payload release (Abstract: self-assembled organic ligand functionalized microcapsules encapsulating one or more substrates, which release the substrate upon activation with power source) – since plural microcapsules encapsulating one or more substrate release the substrate upon activation, it indicates that there are at least two microcapsules are accumulated at the target site. Each microcapsule has its payload. Having plural microcapsules increases the total payload, hence increases the amount of the drug being release.
Allowable Subject Matter
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The limitations recited in claim 21 in regard to the features of “directing the at least one microcapsule to overcome physical barriers, fluid shear, confined spaces, sticky tissues, sticky surfaces, or combinations thereof by inducing the motions ", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Du et al., “biocompatible magnetic and molecular dual-targeting polyelectrolyte hybrid hollow microspheres for controlled drug release”. Molecular Pharmaceutics 2013, 10, 1705-1715, hereinafter Du. This reference discloses construction of a metal oxide-based microcapsule for controlled drug release. It discloses procedures in regard to when the therapeutic drug is introduced relative to the formation of the microcapsule.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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