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 with traverse of Species I (Figure 3) in the reply filed on December 23, 2025, is acknowledged. The traversal is on the ground(s) that: Applicant further requests reconsideration and withdrawal of the requirement. In particular, Applicant submits that all of the claims could be searched by one Examiner without undue effort. Applicant also believes that it is not mandatory to make a restriction requirement in every possible situation. Applicant believes that if one Examiner acts on all of the claims of the present application, overall examining time will be less than if multiple Examiners are involved. Applicant also earnestly believes that the examination of all of the claims by one Examiner in the present application will best ensure uniform prosecution quality. Therefore, in the interests of prosecution quality and economy of time for both the Office and Applicant, Applicant respectfully submits that withdrawal of the restriction requirement in this application is appropriate (Remarks, pages 2-3).
This is not found persuasive because this application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1. Under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Species I-VIII lack unity of invention because even though the inventions of these groups require the technical feature of a device for treatment or prevention of a bacterial, viral, fungal, or protozoan infection, stimulation of the immune system, or providing a wall of inhibition around a catheter placement to protect against the development of microbial biofilm or infection from the puncture site comprising: a wire comprising a metal or metallic alloy that releases ions when a low-intensity direct current is applied to the wire, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Koehler (US 2020/0009375).
Koehler teaches a device (Figure 1) for treatment or prevention of a bacterial, viral, fungal, or protozoan infection (Abstract: A device for killing blood-borne pathogens)(paragraph [0030]: Protection of all of these specifically to the different pathogens: HIV, Viral Hepatitis, MRSA and antibiotic resistant bacteria, vector borne diseases, fungal, protozoa and prions), comprising: a wire (wire 1) comprising a metal or metallic alloy (paragraph [0047]: Among the contemplated wires are 100% silver, 100% gold, 100% copper, and various combinations thereof, with preferred embodiments of the invention having anywhere from 70% or more of one the three main metallic options and the remaining 30% from one or a combination of the two remaining materials) that releases ions when a low-intensity direct current is applied to the wire (paragraph [0048]: The purpose of the pin is to supply low intensity direct current to the device which creates the ionic release, or actually accelerates the ionic release).
Thus, unity of invention is lacking among Species I-VII.
The requirement is still deemed proper and is therefore made FINAL.
Currently, claims 25-28, 30, and 33-36 are under examination as readable on elected Species I (Figure 3).
Information Disclosure Statement
The information disclosure statement filed April 16, 2024, fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered:
No English translation has been provided for understanding of foreign patent documents 6, 8-10, and 12
The information disclosure statement filed November 17, 2025, fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered:
No English translation has been provided for understanding of foreign patent document 1
No English translation has been provided for understanding of non-patent literature document 1
Specification
The abstract of the disclosure is objected to because:
In line 2, "the generation" should be changed to "generation"
In line 2, "Such metal ions" should be changed to "The metal ions"
In line 3, "generation" should be changed to "the generation"
In line 3, "ions" should be changed to "the metal ions"
In line 3, "The activity" should be changed to "Activity"
In line 3, "methods" should be changed to "the methods"
In line 4, "methods" should be changed to "the methods"
In line 5, "the device" should be changed to "the devices"
In line 5, "the surface" should be changed to "a surface"
In line 5, "the pathogen" should be changed to "a pathogen"
In line 6, "methods" should be changed to "the methods"
In line 6, "the development" should be changed to "development"
In line 7, "the administration" should be changed to "administration"
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
The Cross-Reference to Related Applications, paragraph [0001] is missing a statement that the application is a 371 of PCT/US22/24434, filed 04/12/2022.
The Brief Description of the Drawings, paragraph [0106], is missing a brief description of Figures 10G and 10H.
Appropriate correction is required.
Claim Objections
Claims 25-26, 30, and 34-36 are objected to because of the following informalities:
In regards to claim 25, line 2, “the immune system” should be changed to “an immune system”.
In regards to claim 25, lines 3-4, “the development” should be changed to “development”.
In regards to claim 25, line 4, “the puncture site comprising:” should be changed to “a puncture site, the device comprising:”.
In regards to claim 25, line 9, “the skin” should be changed to “skin”.
In regards to claim 25, line 10, “the vein” should be changed to “a vein”.
In regards to claim 25, line 10, “a patient” should be changed to “the patient”.
In regards to claim 26, lines 1-2, “a metal or metallic alloy” should be changed to “the metal or metallic alloy”.
In regards to claim 26, line 2, “the group” should be changed to “a group”.
In regards to claim 30, lines 1-2, “a current” should be changed to “the current”.
In regards to claim 34, line 2, “the ability” should be changed to “an ability”.
In regards to claim 34, lines 2-3, “the therapeutic application” should be changed to “an therapeutic application”.
In regards to claim 35, lines 1-2, “constant current” should be changed to “the current as a constant current”.
In regards to claim 36, line 2, “current” should be changed to “the current”.
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 26-28, 30, and 33-34 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 regards to claim 26, lines 13-14 recite: an alloy of silver, copper, and gold in which the alloy comprises "between 1% and 99% each of gold, silver, and copper". For example, the claim allows each of silver, copper, and gold to be 98% (98% gold, 98% silver, and 98% copper) or 50% (50% gold, 50% silver, and 50% copper), wherein it is unclear how such would be possible resulting in more than 100% in total.
In regards to claim 27, line 2, the term “about 2x109 to about 7x1012 ions per second” is a relative term which renders the claim indefinite. The term “about 2x109 to about 7x1012 ions per second” 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.
In regards to claim 28, line 2, the term “about 1.2 V” is a relative term which renders the claim indefinite. The term “about 1.2 V” 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.
In regards to claim 30, line 2, the term “about 10 µA” is a relative term which renders the claim indefinite. The term “about 10 µA” 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.
In regards to claim 33, lines 1-2 recite: “The device… further comprising a power supply in electrical contact with the device”. “The device… further comprising a power supply” is understood to mean that the power supply is a component of the device. However, “a power supply in electrical contact with the device” is understood to mean that the power supply is a separate component from the device. It is unclear how the power supply can be both a component of the device and a separate component from the device. Claim 34 is rejected by virtue of being dependent upon claim 33.
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 25-27, 30, and 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koehler (US 2020/0009375).
In regards to claim 25, Koehler teaches a device (Figure 3) for treatment or prevention of a bacterial, viral, fungal, or protozoan infection, stimulation of the immune system, or providing a wall of inhibition around a catheter placement to protect against the development of microbial biofilm or infection from the puncture site (Abstract: A device for killing blood-borne pathogens)(paragraph [0030]: Protection of all of these specifically to the different pathogens: HIV, Viral Hepatitis, MRSA and antibiotic resistant bacteria, vector borne diseases, fungal, protozoa and prions) comprising:
a wire (1) comprising a metal or metallic alloy (paragraph [0047]: Among the contemplated wires are 100% silver, 100% gold, 100% copper, and various combinations thereof, with preferred embodiments of the invention having anywhere from 70% or more of one the three main metallic options and the remaining 30% from one or a combination of the two remaining materials) that releases ions when a low-intensity direct current is applied to the wire (paragraph [0048]: The purpose of the pin is to supply low intensity direct current to the device which creates the ionic release, or actually accelerates the ionic release)
an insulated covering (2) that insulates a portion of the wire (Figure 3)
a connector (5)
an electrode (12) that rests on top of the skin of a patient when the insulated covering and the wire are inserted into the vein of a patient (Figure 3)(paragraph [0062]: electrode 12 rests on top of the patient's skin, while the insulated covering 2 and wire 1 have been inserted into the patient's vein)
In regards to claim 26, Koehler et al teaches wherein the wire comprising a metal or metallic alloy is an alloy of gold and silver in which the alloy comprises 70% or more of gold and 30% or less of silver (paragraph [0010]: >70% gold, <30 silver).
In regards to claim 27, Koehler et al teaches wherein the device releases from about 2x109 to about 7x1012 ions per second in operation (paragraph [0054]: The device provides a range that is from 2.0 billion ions per second to 7.0 trillion ions per second).
In regards to claim 30, Koehler et al teaches wherein the device employs a current of less than about 10µA (paragraph [0066]: an output current from the device in the range of 1.25 to 6.0 micro amps of current).
In regards to claim 33, Koehler et al teaches a power supply (paragraph [0048]: power supply) in electrical contact with the device.
In regards to claim 34, Koehler et al teaches wherein the power supply in electrical contact with the device has the ability to adjust the current based on the therapeutic application of the device (paragraph [0013]: a proprietarily designed power supply that we call NANDI, has within it a PCB (printed circuit board) with proprietary software that controls current… for the various programs for treating blood borne pathogens).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Koehler, as applied to claim 25 above, and further in view of Fields et al (US 6,066,489).
In regards to claim 28, Koehler et al is silent about wherein the device employs a voltage of about 1.2 V or less. Fields et al teaches a device (Figures 1-8) wherein the device employs a voltage of about 1.2 V or less (column 8, lines 61-62: 0.86 volts). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device, of Koehler, to employ a voltage of 0.86 V, as taught by Fields et al, which is in the claimed voltage range of about 1.2 V or less, because the wire as an electrode releases silver cations, there is a chemical reaction that occurs on the surface of the electrode involving silver and oxygen that results in a nonconductive oxide on its surface, and over the treatment period, this oxide increases the surface resistance on the electrode, wherein this increased resistance requires that the power supply increase the voltage applied to the electrode to produce the same number of silver ions throughout the treatment period, and thus, the power supply adjusts its voltage to maintain the proper current level and hence voltage level, however, at 0.88 volts and higher, the oxide can be forced off of the electrode, which could cause blood clots, stroke and the like, and therefore the device has a voltage limit of 0.86 volts (column 8, lines 47-62).
Allowable Subject Matter
Claims 35-36 are 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.
In regards to dependent claim 35, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a device for treatment or prevention of a bacterial, viral, fungal, or protozoan infection, stimulation of the immune system, or providing a wall of inhibition around a catheter placement to protect against the development of microbial biofilm or infection from the puncture site, as claimed, specifically including wherein the device provides constant current with a cap on voltage.
Koehler teaches wherein the device provides a cap on voltage (paragraph [0060]: a clamp for input voltage)
However, Koehler is silent about wherein the device provides constant current with the cap on voltage.
Thus, dependent claim 35 is objected to as being dependent upon a rejected base claim 25, but would be allowable if rewritten in independent form including all of the limitations of the base claim 25.
In regards to dependent claim 36, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a device for treatment or prevention of a bacterial, viral, fungal, or protozoan infection, stimulation of the immune system, or providing a wall of inhibition around a catheter placement to protect against the development of microbial biofilm or infection from the puncture site, as claimed, specifically including wherein the device provides constant voltage with a cap on current.
Koehler teaches wherein the device provides a cap on current (paragraph [0060]: a clamp on the output current generator).
However, Koehler is silent about wherein the device provides constant voltage with the cap on current.
Thus, dependent claim 36 is objected to as being dependent upon a rejected base claim 25, but would be allowable if rewritten in independent form including all of the limitations of the base claim 25.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783