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 .
Response to Amendment
The amendment filed 05/12/2026 has been entered. Claims 7-9,11-12, and 26-37 are pending in the application.
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 Claims 1-8, 10, and 16-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 § 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.
Claims 7-9,11-12, and 26-37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for having a state-change element that transitions from a first state to the second state and “state-change elements including temperature-responsive elements, pressure-responsive elements, or vibration-responsive elements that are operable to change a state in response to temperature thresholds being reached. These changes of state can then be used to convert motion or actuation of other elements in order to provide a counter mechanism that advances as the instrument is subjected to the predefined temperature thresholds, triggering a reprocessing or other “use” of the instrument associated with a preset environmental condition or set of conditions to which the instrument is subjected” (applicant’s specification [0190]) does not reasonably provide enablement for state-change element that transitions from a third state to a fourth state and “wherein in the first state the circuit is open and in the second state the circuit is closed, and wherein in the third state the circuit is closed and in the fourth state the circuit is open” (claim 34). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims. Since the specification only discloses a state-change element that transitions from a first state to the second state and is silent with respect to a third and fourth state change, it is not clear what the third/fourth state changes are directed to. Are the states directed to the wax motor, thermocouple, temperature switch/switches, shape-memory alloy member, or some other state change device? What the third/fourth states/state changes are limited to?
Applicants instant specification recites: “can include one or more state-change elements, such as, but not limited to, for example, temperature-responsive elements, pressure-responsive elements, or vibration-responsive elements, that undergo a change of state in response to a change in an environmental condition [0103]... Other state-change elements can include pressure-responsive elements, such as, but not limited to pressure-responsive actuators that generate movement based on application of pressures deviating from a set pressure, such as an atmospheric pressure, energy harvesting devices that generate an electrical current based on application of mechanical energy, such as ultrasonic vibration, or other devices that exhibit a change in state based on a change in conditions to which the element is exposed [0105]… any of the state-change components and devices discussed elsewhere herein, such as, but not limited to, shape-memory alloy components, wax motors or other bladder- or reservoir-type devices, bimetallic components, pressure-responsive actuators, or any other device that can be configured to provide reciprocating linear motion” [0166]… a pressure-responsive actuator including a diaphragm, a piston-cylinder device, or other type of pressure-responsive element ([0171], applicant’s specification).
The specification does provide support for state-change elements and at least two states but unclear if there are more than two states what the specific third and fourth states are. Given the large number of possible state change devices it is not clear what third and fourth state changes are and what to what degree the voltage is required to produce these third and fourth state changes.
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 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) 7-9, 13, and 37 is/are rejected under 35 U.S.C. 103 as obvious over Schulze (US 5969315 A) in view of Snow et al. (US 20140012289 A1) and further in view of Rosenheimer (US 20020091327 A1).
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).
Schulze fails to explicitly disclose the circuit is: transitionable from a first state to a second state in response to a first predetermined temperature being reached in an autoclave environment to which the medical instrument is subjected, and transitionable from a third state to a fourth state in response to a second predetermined temperature being reached in the autoclave environment to which the medical instrument is subjected, the second predetermined temperature differing from the first predetermined temperature.
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 Schulze 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 circuit to be transitionable from a first state to a second state in response to a first predetermined temperature being reached in an autoclave environment to which the medical instrument is subjected, and transitionable from a third state to a fourth state in response to a second predetermined temperature being reached in the autoclave environment to which the medical instrument is subjected, the second predetermined temperature differing from the first predetermined temperature to have precise number of maximum operations of the tool, detect malfunction, detect other need temperature thresholds for different sensor devices and more precise sterilization feedback purposes as taught by Snow et al. and Rosenheimer.
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).
Regarding claim 37, Schulze discloses an indicator (160) that is configured to move through a plurality of positions, each position of the plurality of positions being associated with a unique indicia of a number of available uses remaining on the medical instrument (col. 6 line 15- col. 7, line 10, claim 5, figs. 1-3).
Claim(s) 7-9, 11-12, 26-31, and 35-37 is/are rejected under 35 U.S.C. 103 as obvious over Leimbach et al. (US 20150272583 A1) in view of Snow et al. (US 20140012289 A1) and further in view of Rosenheimer (US 20020091327 A1).
Regarding claims 7-9, Leimbach et al. discloses a medical instrument (2200) comprising: a state change element (transistor 4008/power indicator, moisture sensor, sensor 2612, voltage sensor and/or resistor [0269-0272] and/or “charging profile may be adjusted by the battery charger 2610” [0280]) having a circuit (usage cycle circuit 2402) and a counter (2408 [0272]) operably coupled to the state change element ([0269-0272]) an electronic non-volatile memory (2404); and a voltage source (power assembly 240) 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 wherein the counter is configured to register each individual transition of the circuit from a first state to a second state based on application of voltage from the voltage source in the second state of the circuit (temperature changes, moisture, and etc. [0145-0147, 0269-0281], figs. 48-59).
Leimbach et al. states: “sensor 2612 is configured to monitor one or more characteristics of the sterilization chamber 2604, such as, for example, chemicals present in the sterilization chamber 2604, temperature of the sterilization chamber 2604, and/or any other suitable characteristic of the sterilization chamber 2604” [0280]
Leimbach et al. fails to explicitly disclose the circuit is: transitionable from a first state to a second state in response to a first predetermined temperature being reached in an autoclave environment to which the medical instrument is subjected, and transitionable from a third state to a fourth state in response to a second predetermined temperature being reached in the autoclave environment to which the medical instrument is subjected, the second predetermined temperature differing from the first predetermined temperature.
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 Leimbach 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 circuit to be transitionable from a first state to a second state in response to a first predetermined temperature being reached in an autoclave environment to which the medical instrument is subjected, and transitionable from a third state to a fourth state in response to a second predetermined temperature being reached in the autoclave environment to which the medical instrument is subjected, the second predetermined temperature differing from the first predetermined temperature to have precise number of maximum operations of the tool, detect malfunction, detect other need temperature thresholds for different sensor devices and more precise sterilization feedback purposes as taught by Snow et al. and Rosenheimer.
Regarding claims 11-12, Leimbach et al. discloses an 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 (“zero power indicator indicates that a sterilization cycle has occurred, the processor 2404 increments the usage cycle count”, temperature parameters, alert exceeding temperature threshold [0238], exceeds a predetermined threshold, predetermined number of sterilizations, “ [0269-0272, 0280]); 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 (temperature changes, moisture, and etc. [0145-0147, 0238, 0269-0281], figs. 48-59).
Regarding claims 26-31, Leimbach et al. discloses the counter comprises an electronic non-volatile memory, and wherein the voltage from the voltage source is applied to the memory, wherein the voltage source comprises a battery (2564/2400), wherein, the memory is configured to record electronic data indicative of a number of applications of the voltage from the voltage source to the memory (counter 2408 has memory module, [0196-0200, 0240, 0257-0272, 0286] further comprising an electronic display (2250) configured to display the number of applications of the voltage from the voltage source to the memory (message of usage/count limit, animated images 2260, 2262, and 2246), wherein the second predetermined temperature is higher than the first predetermined temperature, wherein the second predetermined temperature is below a maximum temperature associated with an autoclave cycle (temperature changes, moisture, and etc. [0145-0147, 0238, 0269-0281], figs. 48-59).
Regarding claims 35-36, Leimbach et al. discloses the circuit comprises: a first temperature-responsive switch transitionable from an open to a closed position in response to reaching the first predetermined temperature in the autoclave environment to which the medical instrument is subjected, and a second temperature-responsive switch transitionable from a closed to an open position upon reaching the second predetermined temperature in the autoclave environment to which the medical instrument is subjected (voltage sensor and use indicator- usage cycle circuit 2402 disables the power assembly 2400 after a predetermined number of sterilizations, reactivated and/or reset and/or resistor pack/fuses are burned to an open position [0272]), wherein on a condition that the medical instrument is exposed to a temperature between the first predetermined temperature and the second predetermined temperature, the first temperature- responsive switch and the second temperature-responsive switch are each in a closed position (disabled when a sterilization cycle is detected, reactivated and/or reset [0145-0147, 0238, 0269-0281], figs. 48-59).
Regarding claim 37, Leimbach et al. discloses an indicator (visible indicator - usage cycle circuit 2402/red flag) that is configured to move through a plurality of positions (red flag, may pop-up), each position of the plurality of positions being associated with a unique indicia of a number of available uses remaining on the medical instrument (message/number of uses, count [0271-0276]).
Claim(s) 32-33 is/are rejected under 35 U.S.C. 103 as obvious over Schulze (US 5969315 A) in view of Snow et al. (US 20140012289 A1) in view of Rosenheimer (US 20020091327 A1) and further in view of Weisshaupt (US 20180221526 A1).
Regarding claims 32-33, Schulze fails to explicitly disclose the first predetermined temperature ranges from 60⁰C to 100⁰C, wherein the second predetermined temperature ranges from 80⁰C to 120⁰C.
Weisshaupt teaches a counter device (1) having a counter (2) for counting sterilization cycles that include a first predetermined temperature ranges from 60⁰C to 100⁰C and second predetermined temperature ranges from 80⁰C to 120⁰C ([0035-0038], figs. 1-5).
Given the teachings of Schulze 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 circuit to measure the first predetermined temperature ranges from 60⁰C to 100⁰C, wherein the second predetermined temperature ranges from 80⁰C to 120⁰C to have precise number of maximum operations of the tool at maximum allowed temperatures, provide a plurality of temperature maximums, detect other need temperature thresholds for different sensor devices and more precise sterilization feedback purposes as taught by Weisshaupt.
Claim(s) 32-33 is/are rejected under 35 U.S.C. 103 as obvious over Leimbach et al. (US 20150272583 A1) in view of Snow et al. (US 20140012289 A1) in view of Rosenheimer (US 20020091327 A1) and further in view of Weisshaupt (US 20180221526 A1).
Regarding claims 32-33, Leimbach et al. fails to explicitly disclose the first predetermined temperature ranges from 60⁰C to 100⁰C, wherein the second predetermined temperature ranges from 80⁰C to 120⁰C.
Weisshaupt teaches a counter device (1) having a counter (2) for counting sterilization cycles that include a first predetermined temperature ranges from 60⁰C to 100⁰C and second predetermined temperature ranges from 80⁰C to 120⁰C ([0035-0038], figs. 1-5).
Given the teachings of Leimbach 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 circuit to measure the first predetermined temperature ranges from 60⁰C to 100⁰C, wherein the second predetermined temperature ranges from 80⁰C to 120⁰C to have precise number of maximum operations of the tool at maximum allowed temperatures, provide a plurality of temperature maximums, detect other need temperature thresholds for different sensor devices and more precise sterilization feedback purposes as taught by Weisshaupt.
Response to Arguments
Applicant’s arguments with respect to claim(s) 7-9,11-12, and 26-37 have been considered but are moot because the new ground of rejection does not rely on all references and the new 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ) rejections/issues the applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Additional prior art considered pertinent: see form 892.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ROBERT LONG whose telephone number is (571)270-3864. The examiner can normally be reached M-F, 9am-5pm, 8-9pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SHELLEY SELF can be reached at (571) 272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT F LONG/Primary Examiner, Art Unit 3731
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