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 .
Acknowledgments
In the reply, filed on July 14, 2026, Applicant amended claims 25, 30, and 35-36.
Applicant cancelled claims 26, 33-34, 50-54, 56, 59-60, 97-100, 102, 105-117, 119, and 122-125.
In the non-final rejection of January 14, 2026, Examiner noted that the information disclosure statement filed April 16, 2024, fails to comply with 37 CFR 1.98(a)(3)(i). Applicant did not address this concern in the reply. Concern is maintained.
Examiner noted that the information disclosure statement filed November 17, 2025, fails to comply with 37 CFR 1.98(a)(3)(i). Applicant did not address this concern in the reply. Concern is maintained.
Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to the Disclosure. Applicant amended the Disclosure. Objection is withdrawn.
Examiner objected to claims 25-26, 30, and 34-36. Applicant amended claims 25, 30, and 35-36, and cancelled claims 26 and 34; however, Applicant did not address all of the objections. Objection is maintained.
Examiner rejected claims 26-28, 30, and 33-34 under 35 U.S.C. 112(b). Applicant persuasively argued against rejections of claims 27-28 and 30 (Remarks, pages 11-12), and cancelled claim 33. Rejection is withdrawn.
In regards to claim 26, Applicant argued: Examiner objects to claim 26 for being unclear how such would be possible resulting in more than 100% in total. Applicant submits that the skilled artisan would readily understand that the total amount of metal in an alloy could not total more than 100%. As such, Applicant submits that the recitation "between 1% and 99% each of gold, silver, and copper" would be understood by the skilled artisan as clearly requiring that a total must not exceed 100% (Remarks, page 11). Examiner disagrees. Claim 26 does not make it clear that the total amount of metal in an alloy could not total more than 100%. Rejection is maintained (now in claim 25, as the limitations of claim 26 have been added to claim 25).
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
Claim Objections
Claims 25 and 35-36 are objected to because of the following informalities:
In regards to claim 25, line 4, “a puncture site comprising:” should be changed to “a puncture site, the device comprising:”.
In regards to claim 25, line 5, “metallic alloy” should be changed to “a metallic alloy”.
In regards to claim 35, line 4, “a puncture site comprising:” should be changed to “a puncture site, the device comprising:”.
In regards to claim 35, line 5, “metallic alloy” should be changed to “a metallic alloy”.
In regards to claim 36, line 4, “a puncture site comprising:” should be changed to “a puncture site, the device comprising:”.
In regards to claim 36, line 5, “metallic alloy” should be changed to “a metallic alloy”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 35 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 35, line 11 recites: wherein the device provides “the constant as a constant current with a cap on voltage”; however, such is new matter not described in the Specification.
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 25, 27-28, and 30 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 25, lines 22-23 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. Claims 27-28 and 30 are rejected by virtue of being dependent upon claim 25.
In regards to claim 35, line 11 recites: wherein the device provides “the constant” as a constant current with a cap on voltage. First, there is insufficient antecedent basis for this limitation in the claim. Second, it is unclear what is meant by “the constant as a constant current with a cap on voltage”.
Examiner suggests changing “the constant” to “the current”, such that the limitation reads “the current as a constant current with a cap on voltage”
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, and 30 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 an immune system, or providing a wall of inhibition around a catheter placement to protect against development of microbial biofilm or infection from a 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 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 skin of a patient when the insulated covering and the wire are inserted into a vein of the 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)
wherein the 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 the 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).
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).
Response to Arguments
Applicant's arguments filed July 14, 2026, have been fully considered but they are not persuasive:
In regards to claim 25, Applicant argued: Applicant submits that Koehler does not explicitly describe the combination of elements in cited paragraph [0010] as forming an alloy. A metal wire comprising >70% gold and <30 silver need not comprise the gold and silver in an alloy. As such, Applicant submits that the novelty rejection of claim 25 and any claims dependent therefrom is improper and respectfully requests withdrawal thereof (Remarks, pages 12-13). Examiner disagrees. The term “alloy” means “a substance composed of two or more metals or of a metal and a nonmetal intimately united usually by being fused together and dissolving in each other when molten” or “a compound, mixture, or union of different things” (https://www.merriam-webster.com/dictionary/alloy). Thus, “metallic alloy” at minimum is understood as a mixture of two or more metals. Koehler states “a mixture of metals… i.e. 1) >70% gold, <30 silver” (paragraph [0010]) which is understood to be metallic alloy, such as an alloy of gold and silver in which the alloy comprises 70% or more of gold and 30% or less of silver, as claimed.
Allowable Subject Matter
Claim 36 is allowed.
In regards to 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 an immune system, or providing a wall of inhibition around a catheter placement to protect against development of microbial biofilm or infection from the puncture site, as claimed, specifically including wherein the device provides constant voltage with a cap on the current.
Koehler teaches a device (Figure 3) for treatment or prevention of a bacterial, viral, fungal, or protozoan infection, stimulation of an immune system, or providing a wall of inhibition around a catheter placement to protect against development of microbial biofilm or infection from a 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), wherein the device provides a cap on the 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 the current.
Thus, claim 36 is allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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