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 without traverse of Species II, Claims 7-9 and 11-15, in the reply filed on 01/13/2026 is acknowledged. Claims 1-8, 10, and 16-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/13/2026.
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 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) 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by GAUTHIER et al. (AU 2013347775 A1).
Regarding claim 7, GAUTHIER et al. teaches a wrench (10/10’/tool 2000) having a state change element (bladder 468) transitions between a first state and a second state (bladder 468 can expand or contract within the body 12- 468a, 468b and 468c) in response to a change in an autoclave environment temperature to which the medical instrument is subjected (page 14); and a counter (counter type circuit) operably coupled to the state change element; wherein the counter (counter type circuit) registers each individual transition of the state change element from the first state to the second state (pages 12-14 and 22-23, figs. 1-27).
Claim(s) 7-9 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schulze (US 5969315 A).
Regarding claims 7 and 13, Schulze discloses a medical instrument (figs. 1 and 3f) comprising: a state change element shape memory alloy (memory metal element spring 22/helical spring 140); and a counter (ratchet wheel 4/counting wheel 120, fig. 3) operably coupled to the state change element; wherein the state change element (spring 22/helical spring 140) transitions between a first state (compressed state) and a second state (expand) in response to a change in an autoclave environment temperature to which the medical instrument is subjected; and wherein the counter (ratchet wheel 4/counting wheel 120) registers each individual transition of the state change element from the first state to the second state (col. 2, line 60- col. 7, line 9, claims 1 and 5, figs. 1-3).
Regarding claim 8, Schulze discloses he counter registers a predefined maximum number of individual transitions of the state change element from the first state to the second state (predetermined number of actuations); the predefined maximum number of individual transitions corresponds to a predefined maximum number of autoclave temperature cycles for the medical instrument; and the counter indicates the medical instrument has been subjected to the predefined maximum number of autoclave temperature cycles (safety spring 18/safety blocking element inhibits further use, (col. 2, line 20-34, col. 3 line 43- col. 7, line 15, figs. 1-3).
Regarding claim 9, Schulze discloses the counter comprises a visible indication (numbers/ display device 160); and the visible indication corresponds to the predefined maximum number of autoclave temperature cycles (predetermined number of heating/autoclaving, col. 2, line 20-34, col. 3 line 43- col. 7, line 15, claims 1-2, figs. 1-3).
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) 11-12 and 14-15 is/are rejected under 35 U.S.C. 103 as obvious over Schulze (US 5969315 A) in view of Waterford et al. (US 20200114178 A1).
Regarding claims 11-12 and 14-15, Schulze fails to disclose the state change element comprises a wax motor, an electronic data indication corresponds to the predefined maximum number of autoclave temperature cycles; and the counter is configured to output the electronic data indication, a first electronic data indication corresponds to a number of autoclave temperature cycles more than zero and less than the predefined maximum number of autoclave temperature cycles; a second electronic data indication corresponds to the predefined maximum number of autoclave temperature cycles; and the counter is configured to output the first electronic data indication and the second electronic data indication, wherein: the medical instrument comprises a voltage source; the state change element comprises a temperature-responsive switch; and the voltage source is coupled to the counter via the temperature-responsive switch.
Waterford et al. teaches a medical mask (1101) that is autoclaved [0280-0315] having a numeric display that counts (1210 [0315-0323) with a state change element comprises a wax motor (shows temperature achieving/exceeding cycles have occurred via wax motor and memory wire [0323-0324], figs. 35-42), an electronic data indication (RFID device) corresponds to the predefined maximum number of autoclave temperature cycles; and the counter is configured to output the electronic data indication (transmitted via a RFID device such as a RFID LE sticker and is received by a conventional NFC/RFID reader and sends data to smartphones and tablets [0347-0351]), a first electronic data indication corresponds to a number of autoclave temperature cycles more than zero and less than the predefined maximum number of autoclave temperature cycles (threshold of sterilizations has been reached [0352]); a second electronic data indication corresponds to the predefined maximum number of autoclave temperature cycles (temperature sensor); and the counter is configured to output the first electronic data indication and the second electronic data indication, wherein: the medical instrument comprises a voltage source (battery); the state change element comprises a temperature-responsive switch (memory wire drives logging Geneva wheel [0324] and/or RFID switch); and the voltage source is coupled to the counter via the temperature-responsive switch (number counter displays that use state change elements to move a Geneva wheel for logging a sterilization cycle on a facemask including data via RFID devices [0320-0333, 0348], figs. 43-48).
Given the teachings of Schulze to have a state change element with a counter for autoclave temperature cycles, it 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 to modify the state change element to comprise a wax motor and have an electronic data indication corresponds to the predefined maximum number of autoclave temperature cycles; and the counter is configured to output the electronic data indication, a first electronic data indication corresponds to a number of autoclave temperature cycles more than zero and less than the predefined maximum number of autoclave temperature cycles; a second electronic data indication corresponds to the predefined maximum number of autoclave temperature cycles; and the counter is configured to output the first electronic data indication and the second electronic data indication, wherein: the medical instrument comprises a voltage source; the state change element comprises a temperature-responsive switch; and the voltage source is coupled to the counter via the temperature-responsive switch to have precise number of maximum operations of the tool, detect malfunction, and more precise sterilization feedback purposes as taught by Waterford et al.
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as obvious over Downey et al. (US 20210059706 A1) in view of Snow et al. (CA 2844035 A1) and further in view of Rosenheimer (US 20020091327 A1).
Regarding claims 7-9, Downey et al. discloses a medical instrument (30/32) comprising: a state change element (handpiece tip 48/50/52 undergo the vibrations, load on handpiece, and temperature [0038, 0047, 0054-0057, 0073, 0080, 0094-0100, 0118]); and a counter (232) operably coupled to the state change element (tip use history field 232 contains data regarding the use of the tip [0117]) an electronic non-volatile memory (EEPROM or an RFID tag 58, processor 96 [0046, 0051]); and a voltage source (power supply 68/voltage measuring circuit 86, console coil 187/) operably coupled to the memory; wherein on the condition the device is exposed to the change in the environmental condition, a voltage from the voltage source is applied to the memory (memory isolation circuit, [0050-0052, 0073, 0094, 0101-0102, 0114-0115, 0142]).
Downey et al. fails to explicitly disclose the state change element transitions between a first state and a second state in response to a change in an autoclave environment temperature to which the medical instrument is subjected; and wherein the counter registers each individual transition of the state change element from the first state to the second state, wherein: the counter registers a predefined maximum number of individual transitions of the state change element from the first state to the second state; the predefined maximum number of individual transitions corresponds to a predefined maximum number of autoclave temperature cycles for the medical instrument; and the counter indicates the medical instrument has been subjected to the predefined maximum number of autoclave temperature cycles and the counter comprises a visible indication; and the visible indication corresponds to the predefined maximum number of autoclave temperature cycles.
Snow et al. teaches a surgical instrument (100) having circuit board (292) that in response to a change in an autoclave environment temperature to which the medical instrument is subjected with a counter (ID chip 406 records usage information, firing counters stored within the ID chips 406 and 408, Autoclave counter) that registers each individual autoclave/usage counts, wherein: the counter registers a predefined maximum number of autoclave temperature cycles for the medical instrument (autoclave cycle limit); and the counter indicates the medical instrument has been subjected to the predefined maximum number of autoclave temperature cycles [0126-0138, 0145, 163] and teaches a visible indication (illumination member 116, figs. 5 and 32-34); and the visible indication corresponds to the predefined maximum number of autoclave temperature cycles [0146-0148, 0176-0186].
Rosenheimer teaches a surgical instrument (probe 18, fig. 1) having a microprocessor (38) with a counter/controller means (30) that detects a state change element transitions between a first state and a second state in response to a change in an autoclave environment temperature to which the medical instrument is subjected (piezo crystal as pressure transducer 19 and/or temperature rise); and wherein the counter (30) registers each individual transition of the state change element from the first state to the second state (overload conditions of pressure transducer, diaphragm deflection/strain gauge), wherein: the counter registers a predefined maximum number of individual transitions of the state change element from the first state to the second state; the predefined maximum number of individual transitions corresponds to a predefined maximum number of autoclave temperature cycles for the medical instrument; and the counter indicates the medical instrument has been subjected to the predefined maximum number of autoclave temperature cycles (switch 32 is closed when maximum number reached) and teaches the counter comprises a visible indication; and the visible indication corresponds to the predefined maximum number of autoclave temperature cycles (window 26 with light-emitting diode 28 feedback, [0011, 0014-0015, 0027, claims 1-4, 18, 21-25, 37, and 44, figs. 1-3)
Given the teachings of Downey et al. to have a state change element with a counter and memory of the state change, it 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 to modify the handpiece tip state change element with a sensor/pressure transducer that transitions between a first state and a second state in response to a change in an autoclave environment temperature to which the medical instrument is subjected; and wherein the counter registers each individual transition of the state change element from the first state to the second state, wherein: the counter registers a predefined maximum number of individual transitions of the state change element from the first state to the second state; the predefined maximum number of individual transitions corresponds to a predefined maximum number of autoclave temperature cycles for the medical instrument; and the counter indicates the medical instrument has been subjected to the predefined maximum number of autoclave temperature cycles to have precise number of maximum operations of the tool, detect malfunction, and more precise sterilization feedback purposes as taught by Snow et al. and Rosenheimer
Conclusion
Additional prior art considered pertinent: see form 892.
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/ROBERT F LONG/Primary Examiner, Art Unit 3731