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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/890,222, filed on 08/17/2022.
Response to Amendment
The amendments under 37 CFR 1.132 filed 03/17/2026 is insufficient to overcome the rejection of claim 1 based upon being anticipated by Ruan (US 20040022669 A1) as set forth in the last Office action because: Ruan (U.S. Pub. No. 20040022669) discloses all aspects of independent claim 1.
Claims 1-21 are currently pending. Acknowledgment is made to canceled claim 22.
Response to Arguments
Applicant's arguments filed 03/17/2026 have been fully considered but they are not persuasive.
Regarding independent claim 1, applicant argues that Ruan (U.S. Pub. No. 20040022669) fails to teach a semipermeable membrane permeable to biologically reactive plasma factors from the plasma discharge space and impermeable to the liquid from the liquid-carrying space. However, Examiner respectfully disagrees. Ruan teaches in paragraphs [0116]-[0122] and Figure 20 a plasma discharge space (Fig 20; discharge initiation region 1606) and a liquid-carrying space adjacent thereto to form an interface (Fig 20; treatment region 1604). Paragraph [0117] states “Film 1602 has good dielectric properties and allows one or more of the non-thermal plasma species to pass from discharge initiation region 1606 to treatment region 1604. However, film 1602 should not allow the gas-liquid mixture 1530 to pass into discharge initiation region 1606” and therefore the film allows plasma factors from the plasma discharge space to cross the film into the liquid-carrying space.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 8, 11, 12, 14, 15, 17-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruan (US 20040022669 A1).
Regarding claim 1, Ruan teaches a medical device for generating a plasma-activated liquid ([0018] Another embodiment of the present invention is directed to fluid, which includes a mammalian biological fluid and a non-thermal plasma), comprising a plasma discharge space (Fig 20; discharge initiation region 1606) and a liquid-carrying space adjacent thereto to form an interface (Fig 20; treatment region 1604), characterized in that the interface comprises a semipermeable membrane (Fig 20; film 1602) permeable to biologically reactive plasma factors from the plasma discharge space ([0117] Film 1602 has good dielectric properties and allows one or more of the non-thermal plasma species to pass from discharge initiation region 1606 to treatment region 1604. However, film 1602 should not allow the gas-liquid mixture 1530 to pass into discharge initiation region 1606) and impermeable to the liquid from the liquid-carrying space ([0117] Film 1602 has good dielectric properties and allows one or more of the non-thermal plasma species to pass from discharge initiation region 1606 to treatment region 1604. However, film 1602 should not allow the gas-liquid mixture 1530 to pass into discharge initiation region 1606).
Regarding claim 2, Ruan teaches the medical device according to claim 1, wherein the semipermeable membrane is configured in such a way that in the liquid-carrying space the liquid the formation of gas bubbles is prevented ([0116] Film 1602 contains gas-liquid mixture 1530 in treatment region 1604 and prevents the gas-liquid mixture from entering into discharge initiation region 1606. Discharge initiation region 1606 can be filled with various gases, such as air, another gas or a gas mixture. Discharge initiation region 1606 can also be substantially void of any gas and held under a vacuum at below-normal atmospheric pressure) ([0117] Film 1602 has good dielectric properties and allows one or more of the non-thermal plasma species to pass from discharge initiation region 1606 to treatment region 1604. However, film 1602 should not allow the gas-liquid mixture 1530 to pass into discharge initiation region 1606).
Regarding claim 8, Ruan teaches the medical device according to claim 1, wherein a positive electrode insulated with a dielectric ([0117] as long as there is at least one other dielectric barrier between electrodes 1524) is adjacent to the plasma discharge space on a side opposite the interface ([0115] Electrodes 1524 and dielectric barriers 1526).
Regarding claim 11, Ruan teaches the medical device according to claim 1, which is tubular and/or hose-shaped ([0083] FIG. 5 is a cross-sectional view of a tubular non-thermal plasma reactor 500).
Regarding claim 12, Ruan teaches the medical device according to claim 1, which is box-shaped ([0116] FIG. 20 electrodes 1524 are parallel plates, and discharge initiation region 1606 and treatment region 1604 are rectangular volumes).
Regarding claim 14, Ruan teaches the medical device according to claim 1, which comprises a gas connection via which a carrier gas can be introduced into plasma discharge space (Fig 20; gas source 1620).
Regarding claim 15, Ruan teaches the medical device according to claim 14, which comprises the gas connection via which the carrier gas can be released from the plasma discharge space ([0120] gas injector 1512 draws gas containing the non-thermal plasma species from initiation region 1606 into gas inlet 1513 to further enhance the mixture of non-thermal plasma species in the liquid being treated. Gas source 1620 replaces the gas drawn out of discharge initiation region 1606).
Regarding claim 17, Ruan teaches the medical device according to claim 1, which comprises a connector for connection to an endoscopic device ([0160] treatment of peritonitis (quasi-dialyzing by injecting sterile water or other dialysate compositions into the peritoneal cavity and cycling the water through an endoscope or catheter having an associated internal or external NTP reactor)) (Fig 40; [0163] The shaft can include any medical instrument, catheter or endoscope-type device, with or without an internal lumen, which can be used to access an internal cavity, such as the interior of a hollow organ or lumen, of a mammal).
Regarding claim 18, Ruan teaches the medical device according to claim 1, which is configured for intermittent or continuous generation of a plasma-activating liquid ([0017] The non-thermal plasma reactor receives the mixture of the biological fluid and the gas bubbles within a reaction volume and generates a non-thermal plasma within the reaction volume to thereby kill at least a portion of pathogens within the biological fluid).
Regarding claim 19, Ruan teaches a system for generating plasma activated liquids, comprising the medical device according to claim 8, and a high voltage source connectable to the medical device for applying high voltage to the electrode ([0065] High voltage power supply 124 supplies power to electrodes 108 and 110).
Regarding claim 20, Ruan teaches a method for generating a plasma activated liquid ([0018] Another embodiment of the present invention is directed to fluid, which includes a mammalian biological fluid and a non-thermal plasma), the method comprising:
providing a device having a plasma discharge space (Fig 20; discharge initiation region 1606) and a liquid-carrying space adjacent thereto to form an interface (Fig 20; treatment region 1604), the interface comprising a semipermeable membrane (Fig 20; film 1602) permeable to biologically reactive plasma factors from the plasma discharge space ([0117] Film 1602 has good dielectric properties and allows one or more of the non-thermal plasma species to pass from discharge initiation region 1606 to treatment region 1604. However, film 1602 should not allow the gas-liquid mixture 1530 to pass into discharge initiation region 1606) and impermeable to the liquid from the liquid-carrying space ([0117] Film 1602 has good dielectric properties and allows one or more of the non-thermal plasma species to pass from discharge initiation region 1606 to treatment region 1604. However, film 1602 should not allow the gas-liquid mixture 1530 to pass into discharge initiation region 1606);
flowing a gas through the plasma discharge space ([0120] gas source 1620, which supplies gas to discharge initiation region 1606 through tube 1622);
flowing a liquid through the liquid-carrying space (Fig 20; [0116] Tube 1516 delivers the gas-liquid mixture 1530 into treatment region 1604);
generating a physical plasma containing biologically reactive plasma factors from the gas in the plasma discharge space ([0118] The resulting electrical field between the electrodes generates non-thermal plasma species within regions 1604 and 1606. Non-thermal plasma species within region 1606 are easily generated, and the discharge across region 1606 is fairly uniform);
allowing the biologically reactive plasma factors to migrate through the semi- permeable membrane into the liquid ([0117] Film 1602 has good dielectric properties and allows one or more of the non-thermal plasma species to pass from discharge initiation region 1606 to treatment region 1604. However, film 1602 should not allow the gas-liquid mixture 1530 to pass into discharge initiation region 1606).
Regarding claim 21, Ruan teaches the method according to claim 20, wherein the device is a medical device for generating a plasma-activated liquid ([0018] Another embodiment of the present invention is directed to fluid, which includes a mammalian biological fluid and a non-thermal plasma).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 3-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruan (US 20040022669 A1) in view of Stange (US 20180303995 A1).
Regarding claim 3, Ruan teaches the medical device according to claim 2, wherein the gas bubbles are macrobubbles ([0076] it was observed that the killing power of the NTP species was greater with smaller gas bubbles than with larger gas bubbles. Also, it has been found that the more evenly the gas bubbles are distributed in the liquid, the more effective the non-thermal plasma generation and pathogen reduction) ([0169] The pore size and other characteristics of the membrane can be selected as desired for the particular procedure being performed. In one embodiment, the pores range in size from 0.1 to 2 micrometers, for example, which are capable of passing the most common blood-borne bacteria. Staphylococcus molecules are spherically-shaped, and about 0.75 micrometers in size, while E-coli are elongated "rounded cylinders" about 0.5 micrometers in diameter by 2 micrometers in length). Ruan fails to fully teach wherein the gas bubbles are macrobubbles that are prevented from crossing the membrane.
However, Stange teaches wherein the semi-permeable membrane has a pore size of less than about 0.1, 0.05, 0.01, 0.005, 0.001, 0.0005 or 0.0001 μm ([0078]). It would have been obvious to one having ordinary skill in the art before the effective filling to have modified the invention of Ruan to include wherein the membrane pore size is small enough to exclude macrobubbles. Doing so would ensure larger bubbles do not cross the membrane.
Further, Raun in view of Stange disclose substantially all the limitations of the claim(s) except for macrobubbles. It would have been obvious to one having ordinary skill in the art at the time the invention was made to expect macrobubbles to be larger than 0.1, 0.05, 0.01, 0.005, 0.001, 0.0005 or 0.0001 μm because it is old and well known, as predicted by the prior art, to be suitable in preventing larger molecules from crossing the membrane.
Regarding claim 4, Ruan teaches the medical device according to claim 1, but fails to teach wherein the semipermeable membrane has an average pore radius of about < 5 nm. However, Stange teaches wherein the semipermeable membrane has an average pore radius of about < 5 nm ([0078] the semi-permeable membrane has a pore size of less than about 0.1, 0.05, 0.01, 0.005, 0.001, 0.0005 or 0.0001 μm). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the semipermeable membrane has an average pore radius of about < 5 nm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 5, Ruan teaches the medical device of claim 4, but fails to teach wherein the semipermeable membrane has an average pore radius of about ≤ 2 nm. However, Stange teaches wherein the semipermeable membrane has an average pore radius of about ≤ 2 nm ([0078] the semi-permeable membrane has a pore size of less than about 0.1, 0.05, 0.01, 0.005, 0.001, 0.0005 or 0.0001 μm). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the semipermeable membrane has an average pore radius of about ≤ 2 nm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 6, Ruan teaches the medical device according to claim 1, but fails to teach wherein the semipermeable membrane has an exclusion limit of about 1000 Daltons. However, Stange teaches wherein the semipermeable membrane has an exclusion limit of about 1000 Daltons ([0078] the diffusion component 110 includes a hollow fiber filter having a semi-permeable membrane with a predetermined molecular weight cut-off. In some embodiments, the semi-permeable membrane has a predetermined molecular weight cut-off of less than about 10,000 Daltons, such as 9,000, 8,000, 7,000, 6,000, 5,000, 4,000, 3,000, 2,000, 1,000, 500 or 100 Daltons). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the semipermeable membrane has an exclusion limit of about 1000 Daltons, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 7, Ruan teaches the medical device according to claim 1, but fails to teach wherein the semipermeable membrane has an exclusion limit of about 500 Daltons. However, Stange teaches medical device according to claim 1, wherein the semipermeable membrane has an exclusion limit of about 500 Daltons ([0078] the diffusion component 110 includes a hollow fiber filter having a semi-permeable membrane with a predetermined molecular weight cut-off. In some embodiments, the semi-permeable membrane has a predetermined molecular weight cut-off of less than about 10,000 Daltons, such as 9,000, 8,000, 7,000, 6,000, 5,000, 4,000, 3,000, 2,000, 1,000, 500 or 100 Daltons). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the semipermeable membrane has an exclusion limit of about 500 Daltons, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 9, 13, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruan (US 20040022669 A1) in view of Schmitt (DE 102017123871 A1).
Regarding claim 9, Ruan teaches the medical device according to claim 1, but fails to teach wherein a ground electrode is arranged in the plasma discharge space on and/or near the interface. However, Schmitt teaches wherein a ground electrode is arranged in the plasma discharge space on and/or near the interface (Fig 9; [Pg 10, Para 2] by means of the high voltage power supply 18 a high-frequency high voltage between the inner electrode 14 and the nozzle tube acting as an outer electrode 4 created. Because the ceramic tube 10 the inner electrode 14 opposite the outer electrode 4 electrically insulated, no direct discharge arcs between the inner and the outer electrode can occur. Instead, there are so-called dielectrically impeded discharges, in the electrical discharges in the discharge space 20 occur between the inner and outer electrodes). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein a ground electrode is arranged in the plasma discharge space on and/or near the interface. Doing so allows for sufficient physical plasma formation between the positive electrode and the ground electrode.
Regarding claim 13, Ruan teaches the medical device according to claim 1, but fails to teach which comprises an enclosing support structure. However, Schmitt teaches which comprises an enclosing support structure (Fig 2; [Pg 10, Para 7] The device 40 includes a container 42 in the form of a glass cylinder). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include comprising an enclosing support structure. Doing so encloses the device and protects the reactor from outside influence.
Regarding claim 16, Ruan teaches the medical device according to claim 1, but fails to teach which comprises a connection for a high- pressure nebulization or spraying unit. However, Schmitt teaches which comprises a connection for a high- pressure nebulization or spraying unit (Fig 3; nebulizer nozzle 72). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include comprising a connection for a high-pressure nebulization or spraying unit. Doing so allows for spraying of the liquid to a treatment site.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruan (US 20040022669 A1) in view of Vangeneugden (US 20080292497 A1).
Regarding claim 10, Ruan teaches the medical device according to claim 1, but fails to teach wherein a ground electrode is disposed within the liquid carrying space. However, Vangeneugden teaches wherein a ground electrode is disposed within the liquid carrying space ([0025] If the liquid itself is not grounded or not connected to a suitable reference, the phase separator 4 is preferably produced from a conductive material, and may be connected to ground or to said reference, as shown in FIG. 2. In this setup, the phase separator and the liquid in area 5 act as the second electrode during operation of the reactor) ([0027] preferably grounded electrode 8 may be applied around the barrier zone 7 (see FIGS. 3 and 4) or it may replace the outer barrier zone 7 and be arranged in direct contact with the liquid in area 5 (FIG. 5)). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein a ground electrode is disposed within the liquid carrying space. Doing so allows charge-driven plasma factors from the plasma to be accelerated through the membrane.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
Prosecution Insights