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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim(s) 1-2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019241833 A1 (“Lea”) (disclosed in Applicant’s IDS dated 06/06/2023) in view of US 20200368379 A1 (“Agarwal”) (disclosed in Applicant’s IDS dated 08/01/2024) and US 20150209461 A1 (“Itarashiki”).
Regarding claim 1, Lea teaches a medical probe sterilizer ([0039], Fig. 1) comprising:
a main body comprising a sterilizing chamber configured to accommodate a medical probe to be sterilized therein and configured to be opened and closed (Fig. 1, sterilizer 100 has a main body with a chamber 104 configured to be closed with door 102 [0042]);
a probe holder installed on the main body and configured to hold the medical probe to be located inside the sterilizing chamber ([0044], Fig. 1, clamp 10 configured to hold ultrasonic probe);
and a sealer configured to prevent leakage of the plasma to an outside of the sterilizing chamber ([0005], door 102 understood to seal chamber when closed with a sealing gasket).
Lea teaches wherein the disinfection process includes a misted disinfection agent to contact the ultrasound probe [0041] but does not teach a UV sterilization unit. One having ordinary skill in the art would be concerned that the misted disinfection agent alone would not be sufficient to sterilize the probe, motivating one to turn towards Agarwal.
Agarwal teaches a medical probe disinfectant system [abstract] including a chamber for exposing a medical probe to a plurality of UV light sources and a misted disinfectant [0024]. Agarwal teaches wherein the combination of chemical disinfectant and UV radiation may generate hydroxyl radicals and further disinfect the surface of the probe [0035].
Agarwal is considered analogous to the claimed invention since both are drawn to sterilization apparatuses. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the main body of Lea with the plurality of UV light sources as taught by Agarwal since Agarwal teaches the UV light to further generate hydroxyl radicals when contacted with the disinfectant mist, leading to increased surface disinfection [0035]. See MPEP 2143(I)(G).
Modified Lea teaches wherein the disinfection process includes a misted disinfection agent to contact the ultrasound probe [Lea, 0041] but does not teach a plasma sterilization processing unit. One having ordinary skill in the art would be concerned that the misted disinfection agent alone would not be sufficient to sterilize the probe, motivating one to turn towards Itarashiki.
Itarashiki teaches a sterilization system comprising a reaction chamber configured to sterilize an object with a disinfection agent and plasma [abstract] wherein the object can be an endoscope [0030-0031]. Itarshiki further teaches where the system comprises a plasma generating unit configured to generate and introduce plasma into the reaction chamber [0036] to remove any residual smell from a chemical disinfection agent [0074].
Itarashiki is considered analogous to the claimed invention since both are drawn to sterilization apparatuses. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sterilization chamber as taught by Lea to include the plasma generating unit as taught by Itarashiki since Itarashiki teaches the plasma to remove the smell of a chemical disinfectant [0074]. See MPEP 2143(I)(G).
Accordingly, the sealer as taught by Modified Lea is airtight [Lea, 0005]and is understood to be capable of preventing the leakage of plasma outside of the sterilization chamber.
Regarding claim 2, Modified Lea teaches the medical probe sterilizer of claim 1, wherein the main body comprises: a housing having the plasma sterilization processing unit installed therein (Lea, Fig. 1, main body of sterilizer 100 comprises a housing connected to a door 102) and having the probe holder and the UV sterilization unit installed on an outer front surface thereof (Fig. 1, probe holder 10 and UV sterilization unit installed on housing, see rejection of claim 1); and a chamber door installed on the outer front surface of the housing, configured to be opened and closed to cover the medical probe held by the probe holder and the UV sterilization unit (Fig. 1, chamber door 102 configured to close and cover the medical probe and enclose sterilization chamber 104 [Lea, 0042] where the UV sterilization unit is located, see claim 1 rejection), and configured to form the sterilizing chamber between the housing in a closed state [Lea, 0005].
Regarding claim 5, Modified Lea teaches at least four UV light sources arranged around a medical probe within a chamber to provide optimal, 360-degree illumination of the probe [Agarwal, 0024]. These sources are each understood to be a sterilization part disposed in the chamber such that one source provides UV radiation to the front of the probe, one provides UV radiation to a lower portion of the probe, and two provide UV radiation to the sides of the probe.
Because the sterilization chamber of Modified Lea is the interior part of housing connected to door 102 (Lea, Fig. 1), these sterilization parts are understood to be protruding from the front surface of the housing. Accordingly, the prior art is understood to teach all the limitations of claim 5 including wherein the UV sterilization unit comprises: a front sterilization part disposed on the front surface of the housing and configured to emit the UV light; a lower sterilization part disposed in a lower part of an inside of the sterilizing chamber, protruding from the front surface of the housing, and configured to emit the UV light to a lower portion of the medical probe; and a pair of side sterilization parts disposed on opposite sides of the front sterilization part, protruding from the front surface of the housing, and configured to emit the UV light to side portions of the medical probe.
Claim(s) 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019241833 A1 (“Lea”) in view of US 20200368379 A1 (“Agarwal”) and US 20150209461 A1 (“Itarashiki”) as applied to claim 2 above, and further in view of US 5725185 A (“Auclair”).
Regarding claim 3, Modified Lea teaches the medical probe sterilizer of claim 2, wherein the probe holder comprises: a first holding member fixedly installed to protrude from the front surface of the housing to be located inside the sterilizing chamber and configured to hold a cable of the medical probe (Lea, [0044], Fig. 1, clamp 10 = first holding member).
Modified Lea does not teach a second holding member located above the first holding member, fixed outside the sterilizing chamber, and configured to support the cable of the medical probe.
One would be concerned with supporting the cable of a heavier probe motivating one to turn towards Auclair, who teaches a cable clamp bracket assembly mountable to an enclosure [abstract] wherein the assembly has an improved pull-out resistance [col 1, lines 56-59] due to a tooth mechanism designed to engaged with a cable jacket [col 4, lines 28-41].
Auclair is considered analogous to the claimed invention since the reference is reasonably pertinent to the problem faced by the inventor (supporting a cable assembly). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the housing as taught by Modified Lea to include the cable clamp bracket assembly as taught by Auclair above the first holding member to provide more support to the probe cable and stabilize it during sterilization and this involves the combination of elements to yield a predictable result with a reasonable expectation of success. See MPEP 243(I)(A).
Regarding claim 4, Modified Lea teaches the medical probe sterilizer of claim 3, wherein the probe holder further comprises a cable clamp coupled with the cable of the medical probe and configured to be held on the second holding member to support a load of the medical probe (Auclair, teaches a cable clamp, Fig. 1, 10, see rejection of claim 3 above).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2019241833 A1 (“Lea”) in view of US 20200368379 A1 (“Agarwal”) and US 20150209461 A1 (“Itarashiki”) as applied to claim 2 above, and further in view of US 5568362 A (“Hansson”).
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Regarding clam 6, Modified Lea teaches the medical probe sterilizer of claim 2, comprising a sealing member installed on a tightly engaging edge of the chamber door configured to come into contact with the housing (Lea, [0005], sealer understood to be a sealing ring on door 102, see Annotation below) configured to come into tight contact with the front surface of the housing. Modified Lea does not teach wherein the sealer comprises a cable sealing holder installed to protrude from the front surface of the housing and having a cable mounting slit configured to allow the cable of the medical probe to be inserted and passed therethrough; and wherein the sealing member comes into tight contact with the cable sealing holder when the chamber door is closed.
One having ordinary skill in the art would be concerned with effectively sealing the chamber in light of the probe cable interrupting the sealer, motivating one to turn towards Hansson who teaches a cabinet with a central casing (Fig. 1, 10) configured to hold cables (18) within a chamber (16). Hansson further teaches wherein the cabinet comprises cable sealing holders (25) on the cabinet door (13) with cable mounting slits (20) for abutting against the cables and sealing the chamber (col 2, lines 16-20) when the door is pressed against the cabinet.
Hansson is considered analogous to the claimed invention since the reference is reasonably pertinent to the problem faced by the inventor (sealing a chamber with a cable assembly). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the chamber door as taught by Modified Lea to include the cable mounting slits and sealing holders as taught by Hansson since Hanson teaches the holders and slits to seal an interior chamber when pressed against a cable assembly (col 2, lines 16-20). See MPEP 2143(I)(G).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2019241833 A1 (“Lea”) in view of US 20200368379 A1 (“Agarwal”) and US 20150209461 A1 (“Itarashiki”) as applied to claim 2 above, and further in view of WO 2017218832 A1 (“Shea”) and US 20170049913 A1 (“Yu”).
Regarding claim 7, Modified Lea teaches the medical probe sterilizer of claim 2, wherein the plasma sterilization processing unit comprises: a plasma generator installed inside the housing and configured to generate and supply the plasma to the sterilizing chamber (Itarashiki, [0036]). Modified Lea does not teach wherein the plasma sterilization processing unit further comprises a plasma recover pump installed inside the housing and configured to suction and recover the plasma supplied to the sterilizing chamber; and a filter installed on a recovery path of the plasma recovered by the plasma recovery pump and configured to filter out and remove ozone.
One having ordinary skill in the art would be concerned with the economics of the sterilization apparatus and seek to reduce the cost of the plasma generation, motivating one to turn towards Shea, who teaches a plasma sterilization system [abstract] with a plasma generator configured to introduce free radicals into a sterilization chamber [0035]. Shea further teaches a circulating pump configured to recycle the plasma effluent through the system and optimize the system by reducing cycle times [0142-0143].
Shea is considered analogous to the claimed invention since both are drawn to sterilization apparatuses. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the plasma sterilization processing unit as taught by Modified Lea with the circulating pump as taught by Shea since Shea teaches the pump to recycle plasma effluent and reduce cycle times [0142-0143]. See MPEP 2143(I)G).
One having ordinary skill in the art would also be concerned the undesired byproduct of ozone generated by the plasma generator leading to a strong smell within the apparatus, motivating one to turn towards Yu who teaches a plasma generating apparatus with ozone destruct means [abstract, 0071]. Yu teaches that an ozone removing filter may be provided between a fan and ozone collection space to remove ozone generated by a plasma generator [0071-0072].
Yu is considered analogous to the claimed invention since both are drawn to sterilization apparatuses. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the plasma sterilization processing unit as taught by Lea with the ozone filter as taught by Yu to remove ozone and prevent the buildup of a strong smell within the apparatus since this involves the combination of elements to yield a predictable result with a reasonable expectation of success. See MPEP 2143(I)(A).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2019241833 A1 (“Lea”) in view of US 20200368379 A1 (“Agarwal”), US 20150209461 A1 (“Itarashiki”), and US 5568362 A (“Hansson”), as applied to claim 6 above, and further in view of US 5959250 A (“Daoud”).
Regarding claim 8, Modified Lea teaches the medical probe sterilizer of claim 6, comprising a cable sealing holder made of a conductive material (Hansson, col 2, lines 16-20) but does not teach wherein the cable sealing holder is made of a material that is elastically deformable by an external force.
One having ordinary skill in the art would be concerned that the conductive material may be non-deformable and damage the medical probe cable when the chamber door is abutted against it, motivating one to turn towards Daoud who teaches an enclosure for sealing telecommunication cables [abstract]. Daoud teaches two elastically deformable inserts (Fig. 2, 202, 204) attached to a mounting surface base aperture and another to a mounting lid such that when the lid is closed, the inserts are deformed to reduce the size of gaps between the cables and edge of the aperture [col 2, lines 45-55] to provide improved sealing properties [col 2, line 61-65].
Daoud is considered analogous to the claimed invention since the reference is reasonably pertinent to the problem faced by the inventor (sealing a chamber with a cable assembly). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the chamber door as taught by Modified Lea to include the elastically deformable cable sealing holder inserts as taught by Daoud since Daoud teaches the inserts to reduce the size of gaps between a cable and aperture when a lid is closed [col 2, lines 45-55] and provide improved sealing properties [col 2, line 61-65]. See MPEP 2143(I)(G).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20080277545 A1 teaches a clamp for supporting a medical device cable.
US 20200360549 A1 teaches a UV disinfection system for medical devices.
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/N.S.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758