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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20 January 2026 has been entered.
Claims 1, 2, and 10-21 are currently under consideration. The Office acknowledges the amendments to claims 1, 13, and 21, as well as the cancellation of claims 3-9.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) and 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 16/379,792, 15/578,218, and 62/181,936, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. None of these applications provide disclosure of such GAC-FENPs that comprise UENPs or Frequency-Electric Nano-Particles (1 Hz to 10 trillion Hz). Accordingly, the effective filing date of the present application remains its actual filing date of 14 August 2021.
Claim Objections
Claims 1 and 21 are objected to because of the following informalities: in lines 20-22 of each claim, “at least one of audio frequency electromagnetic field generator, radio frequency electromagnetic field generator, optical frequency electromagnetic field generator, and near” should apparently read --at least one of an audio frequency electromagnetic field generator, a radio frequency electromagnetic field generator, an optical frequency electromagnetic field generator, and a near--. 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 1, 2, and 10-21 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.
Claim 1 recites the limitations “wherein the external energy field generation module includes an ultrasonic transducer or a beam-forming transducer array [0060]; and an electromagnetic field generator for one or more of the following frequency ranging from 1 Hz to 10 trillion Hz (THz), comprising at least one of audio frequency electromagnetic field generator, radio frequency electromagnetic field generator, optical frequency electromagnetic field generator, and near or far infrared frequency electromagnetic field generator [0027]” in lines 17-22. These limitations are messy and unclear.
First, it is not clear what is meant by the inclusion of “[0060]” and “[0027].” Are these intended to refer to certain paragraph numbers of the specification? If so, this is improper for the claims.
Second, “one or more of the following frequency ranging from 1 Hz to 10 THz” has numerous issues. It is not clear if this is intended to mean “following frequency ranges” or “following frequencies ranging” (or something else). Further, only a single frequency range is recited.
Third, it is not clear if the claim is intended to recite that the external energy field generation module includes both (1) an ultrasonic transducer or a beam-forming transducer array and (2) an electromagnetic field generator, or if it is only intended to include at least one (e.g., an ultrasonic transducer when the GAC-FENPs are UENPs and an electromagnetic field generator when the GAC-FENPs are Frequency-Electric Nano-Particles.
Regarding the "navigation module" in claim 10, the "ultrasound energy field generation module" in claim 11, and the "removal module" of claims 18-20, as detailed in the previous Office action, these limitations invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed functions and to clearly link the structure, material, or acts to the functions. The specification teaches that both the navigation module and the removal module can be independent modules (and not part of the external energy field generation module), without providing any disclosure of what structure these modules may comprise; and fails to provide any disclosure of the structure of the ultrasound energy field generation module. Therefore, the claims are indefinite and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claims so that the claim limitations will no longer be interpreted as limitations under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed functions, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the functions recited in the claims, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the functions so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed functions, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed functions and clearly links or associates the structure, material, or acts to the claimed functions, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed functions. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 13 recites the limitation "an electric field" in line 3. It is not clear if this is intended to refer to a previously recited electric field or a new electric field.
Claims 2 and 10-20 are rejected by virtue of their dependence upon at least one rejected base claim.
Claim 21 recites the limitations “wherein the external energy field generation module includes an ultrasonic transducer or a beam-forming transducer array [0060]; and an electromagnetic field generator for one or more of the following frequency ranging from 1 Hz to 10 trillion Hz (THz), comprising at least one of audio frequency electromagnetic field generator, radio frequency electromagnetic field generator, optical frequency electromagnetic field generator, and near or far infrared frequency electromagnetic field generator [0027]” in lines 17-22. These limitations are messy and unclear.
First, it is not clear what is meant by the inclusion of “[0060]” and “[0027].” Are these intended to refer to certain paragraph numbers of the specification? If so, this is improper for the claims.
Second, “one or more of the following frequency ranging from 1 Hz to 10 THz” has numerous issues. It is not clear if this is intended to mean “following frequency ranges” or “following frequencies ranging” (or something else). Further, only a single frequency range is recited.
Third, it is not clear if the claim is intended to recite that the external energy field generation module includes both (1) an ultrasonic transducer or a beam-forming transducer array and (2) an electromagnetic field generator, or if it is only intended to include at least one (e.g., an ultrasonic transducer when the GAC-FENPs are UENPs and an electromagnetic field generator when the GAC-FENPs are Frequency-Electric Nano-Particles.
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, 11-13, 16, 17, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peyman (U.S. Pub. No. 2020/0246179 A1).
Regarding claim 1, Peyman discloses an antimicrobial apparatus for disrupting, deactivating or destroying microorganisms comprising at least one of bacteria, fungus, viruses, or diseased cells (Abstract; [0108]; [0161]-[0162]), the antimicrobial apparatus comprising:(i) Guiding-Agent-Conjugated Field-Electric Nanoparticles (GAC-FENPs) that are produced by coating, binding, functionalizing or conjugating to Field-Electric Nano-Particles (FENPs) other than Magneto-Electric Nano-Particles (MENPs) comprising at least one of Ultrasonic-Electric Nano-Particles (UENPs), and Frequency-(1 Hz to 10 trillion Hz)-Electric Nano-Particles with one or more guiding agents that specifically target or bind to targeted bacteria, fungus, viruses, or diseased cells ([0103]; [0105]; [0108]; [0113]-[0117]; [0179]); (ii) a delivery module configured to deliver the GAC-FENPs into a subject's body ([0024]-[0027]; ); and (iii) an external energy field generation module configured to generate and apply an external energy field to act on the GAC-FENPs after the GAC-FENPs are in the proximity of, or bind to, the targeted bacteria, fungus, viruses, or diseased cells and produce a localized electric field or pulses of an electric field that acts or act on the targeted bacteria, fungus, viruses, or diseased cells to disrupt or deactivate a function of, or destroy, the targeted bacteria, fungus, viruses, or diseased cells, wherein the external energy field generation module includes an ultrasonic transducer or a beam-forming transducer array and an electromagnetic field generator for one or more of the following frequency ranging from 1 Hz to 10 trillion Hz (THz), comprising at least one of audio frequency electromagnetic field generator, radio frequency electromagnetic field generator, optical frequency electromagnetic field generator, and near or far infrared frequency electromagnetic field generator ([0032]; [0126]; [0128]; [0160]; [0291]).
Regarding claim 2, Peyman discloses that the one or more guiding agents comprise one or more of immunoglobulin, antibody, antibody mimetic, cell adhesion peptides, ligands, or other molecules or proteins that have an affinity to or bind to the targeted bacteria, fungus, viruses, or diseased cells ([0018]-[0022]; [0105]).
Regarding claim 11, Peyman discloses that the external energy field generation module comprises an ultrasound energy field generation module, the Field-Electric Nano-Particles (FENPs) comprise Ultrasonic-Electric Nano-Particles (UENPs), and the GAC-FENPs comprise Guiding-Agent-Conjugated Ultrasonic-Electric Nanoparticles (GAC-UENPs) and wherein the external energy field generation module generates an ultrasound energy field and applies the ultrasound energy field to act on the GAC-UENPs ([0032]; [0126]; [0128]; [0160]; [0291]).
Regarding claim 12, Peyman discloses that the delivery module comprises an injection syringe for injecting a solution of the GAC-FENPs into the subject's body, an aerosolization device for inhalation of the GAC-FENPs into the subject's body, a pressured or diffusion delivery device for infusing the GAC-FENPs into the subject's body across skin, or an encapsulation device to produce capsules or pills containing the GAC-FENPs for ingesting the GAC-FENPs into the subject's body ([0019]; [0022]; [0025]; [0370]).
Regarding claim 13, Peyman discloses that the external energy field generation module is configured to adjust a characteristic of the generated external energy field so that it causes an electric field on the GAC-FENPs bound to the targeted bacteria, fungus, viruses, or diseased cells to disrupt or deactivate or damage the targeted bacteria, fungus, viruses, or diseased cells but it does not cause other GAC-FENPs that still remain in the subject's body but unbound to the targeted bacteria, fungus, viruses, or diseased cells to harm healthy or untargeted cells ([0043]; [0052]; [0064]; [0182]).
Regarding claim 16, Peyman discloses that the external energy field generation module is configured to generate and apply the external energy field after a waiting period to give the subject's body sufficient time to excrete most or all of free GAC-FENPs that did not bind to the targeted bacteria, fungus, viruses, or diseased cells out of the subject's body, and/or for the GAC-FENPs to target or bind to the targeted bacteria, fungus, viruses, or diseased cells before generating and applying the external energy field to cause a damage to the targeted bacteria, fungus, viruses, or diseased cells (capable of such intended use; e.g., simply waiting a sufficient time after administering the GAC-FENPs before applying the external energy field).
Regarding claim 17, Peyman discloses that the FENPs are coated, bound, conjugated or functionalized both with one or more drugs, molecules or chemicals that modify, affect or neutralize the targeted bacteria, fungus, viruses, or diseased cells and the one or more guiding agents that target the targeted bacteria, fungus, viruses, or diseased cells to produce Guiding-Agent-Conjugated Drug-Coated FENPs (GAC-DC-FENPs) ([0038]; [0240]).
Regarding claim 21, Peyman discloses an antimicrobial apparatus for disrupting, deactivating or destroying microorganisms comprising at least one of bacteria, fungus, viruses, or diseased cells (Abstract; [0108]; [0161]-[0162]), the antimicrobial apparatus comprising:(i) Drug-Coated Field-Electric Nanoparticles (DC-FENPs) wherein the Field-Electric Nano-Particles (FENPs) other than Magneto-Electric Nano-Particles (MENPs) comprising at least one of Ultrasonic-Electric Nano-Particles (UENPs), and Frequency-(1 Hz to 10 trillion Hz)-Electric Nano-Particles are coated, bound, conjugated or functionalized with one or more drugs, molecules or chemicals that modify, affect or neutralize targeted bacteria, fungus, viruses, or diseased cells ([0038]; [0103]; [0105]; [0108]; [0113]-[0117]; [0179]; [0240]); (ii) a delivery module configured to deliver the DC-FENPs into a subject's body ([0024]-[0027]; ); and (iii) an external energy field generation module configured to generate and apply an external energy field to act on the DC-FENPs after the DC-FENPs are in the proximity of, or bind to, the targeted bacteria, fungus, viruses, or diseased cells and produce a localized electric field or pulses of an electric field that acts or act on the targeted bacteria, fungus, viruses, or diseased cells to disrupt or deactivate a function of, or destroy, the targeted bacteria, fungus, viruses, or diseased cells, wherein the external energy field generation module includes an ultrasonic transducer or a beam-forming transducer array and an electromagnetic field generator for one or more of the following frequency ranging from 1 Hz to 10 trillion Hz (THz), comprising at least one of audio frequency electromagnetic field generator, radio frequency electromagnetic field generator, optical frequency electromagnetic field generator, and near or far infrared frequency electromagnetic field generator ([0032]; [0126]; [0128]; [0160]; [0291]).
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 10, 14, 15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman as applied to claim 1 above, and further in view of Liang (U.S. Pub. No. 2019/0232074 A1).
Regarding claim 10, Peyman discloses the invention as claimed, but fails to disclose a navigation module that generates a second external energy field and uses the second external energy field to guide, attract and/or enhance accumulation of the GAC-FENPs into a site with a high concentration of the targeted bacteria, fungus, viruses, or diseased cells. Peyman does teach that the GAC-FENPs may be both piezoelectric and magnetic ([0106]; [0291]). Liang discloses a similar apparatus (Abstract) comprising a module that generates a first external energy field ([0042]-[0044]; [0049]-[0050]) and a navigation module that generates a second external energy field and uses the second external energy field to guide, attract and/or enhance accumulation of nanoparticles into a site with a high concentration of the targeted bacteria, fungus, viruses, or diseased cells, in order to increase the accumulation of the nanoparticles at a targeted site and prevent spreading from the targeted site ([0022]; [0063]; [0066]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Peyman with a navigation module that generates a second external energy field and uses the second external energy field to guide, attract and/or enhance accumulation of the GAC-FENPs into a site with a high concentration of the targeted bacteria, fungus, viruses, or diseased cells, as taught by Liang, in order to increase the accumulation of the GAC-FENPs at a targeted site and prevent spreading from the targeted site.
Regarding claim 14, Peyman discloses the invention as claimed, but fails to disclose that surfaces of the FENPs are first coated, functionalized or conjugated with one or more layer of material, molecule or compound to modify a property of the surfaces of the FENPs before being coated, conjugating or functionalized with the one or more guiding agents that target or bind to the targeted bacteria, fungus, viruses, or diseased cells to produce the GAC-FENPs. Liang discloses a similar apparatus (Abstract) wherein surfaces of nanoparticles are first coated, functionalized or conjugated with one or more layer of material, molecule or compound to modify a property of the surfaces of the nanoparticles before being coated, conjugating or functionalized with one or more guiding agents that target or bind to targeted bacteria, fungus, viruses, or diseased cells to produce the nanoparticles in order to allow for covalent attachment of the one or more guiding agents ([0021]; [0047]; [0062]; [0079]-[0080]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Peyman so that surfaces of the FENPs are first coated, functionalized or conjugated with one or more layer of material, molecule or compound to modify a property of the surfaces of the FENPs before being coated, conjugating or functionalized with one or more guiding agents that target or bind to targeted bacteria, fungus, viruses, or diseased cells to produce the GAC-FENPs, as taught by Liang, in order to allow for covalent attachment of the one or more guiding agents.
Regarding claim 15, Peyman discloses the invention as claimed, and further discloses that the external energy field generation module generates and applies a second external energy field to cause the GAC-FENPs to generate the localized electric field or pulses of electric field to disrupt the function of, deactivate the function of, or destroy the targeted bacteria, fungus, viruses, or diseased cells (see rejection of claim 1). Peyman fails to disclose that before generating and applying this second external energy field, the external energy field generation module is configured to generate and apply a first external energy field to lead to a higher concentration of GAC-FENPs at and around the targeted site or in an organ or body part with a high concentration of the targeted bacteria, fungus, viruses, or diseased cells. Peyman does teach that the GAC-FENPs may be both piezoelectric and magnetic ([0106]; [0291]). Liang discloses a similar apparatus (Abstract) comprising an external energy field generation module that generates a second external energy field to cause nanoparticles to generate a localized electric field or pulses of electric field to disrupt the function of, deactivate the function of, or destroy targeted bacteria, fungus, viruses, or diseased cells ([0042]-[0044]; [0049]-[0050]) and that, before generating and applying this second external energy field, generates and applies a first external energy field to lead to a higher concentration of the nanoparticles at and around a targeted site or in an organ or body part with a high concentration of the targeted bacteria, fungus, viruses, or diseased cells, in order to increase the accumulation of the nanoparticles at a targeted site and prevent spreading from the targeted site ([0022]; [0063]; [0066]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Peyman so that the external energy field generation module also is configured to generate and apply such a first external energy field to lead to a higher concentration of the GAC-FENPs at and around a targeted site or in an organ or body part with a high concentration of the targeted bacteria, fungus, viruses, or diseased cells, as taught by Liang, in order to increase the accumulation of the GAC-FENPs at a targeted site and prevent spreading from the targeted site.
Regarding claim 18, Peyman discloses the invention as claimed, but fails to disclose a removal module configured for removing the GAC-FENPs from the subject's body. Peyman does teach that the GAC-FENPs may be both piezoelectric and magnetic ([0106]; [0291]). Liang discloses a similar apparatus (Abstract) comprising a removal module configured for removing nanoparticles from the subject's body in order to remove the nanoparticles from the body when desired ([0040]-[0041]; [0074]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Peyman with such a removal module, as taught by Liang, in order to remove the GAC-FENPs from the body when desired.
Regarding claim 19, the combination of Peyman and Liang discloses the invention as claimed, see rejection supra, and Liang further discloses that the removal module is configured to produce a sufficiently strong energy field and apply it to areas of the subject's body that contain GAC-FENPs to attract the GAC-FENPs and facilitate removal of the GAC-FENPs from the subject's body ([0040]-[0041]; [0074]).
Regarding claim 20, the combination of Peyman and Liang discloses the invention as claimed, see rejection supra, and Liang further discloses that the removal module is configured to apply an extraction solution that contains agents that bind to the GAC-FENPs and attract the GAC-FENPs bound with the agents to a surface of the subject's body for removal ([0040]-[0041]; [0074]).
Response to Arguments
Applicant's arguments with respect to the priority claim have been fully considered but they are not persuasive. As detailed supra, the prior-field applications do not disclose the presently-claimed subject matter.
Applicant’s arguments with respect to the objection to claim 13 have been fully considered and are persuasive in light of the amendments. The objection has been withdrawn.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive in light of the amendments. The rejections have been withdrawn. However, as detailed supra, the amendments have resulted in new rejections under 35 U.S.C. 112(b).
Applicant’s arguments with respect to the rejection of claim 21 under 35 U.S.C. 101 have been fully considered and are persuasive in light of the amendments. The rejection has been withdrawn.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102 and 103 have been fully considered and are persuasive in light of the amendments. The rejections have been withdrawn. However, as detailed supra, the amendments have resulted in new rejections under 35 U.S.C. 102 and 103.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791