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 .
Specification
The disclosure is objected to because, in paragraph [0001] of the filed application, U.S. Pat. No. 12,070,239 is not cited as being issued from U.S. Pat. App. No. 17/860,241.
The disclosure is also objected to because of an informality, which can be corrected as follows: In paragraph [000209] of the filed specification, element number “(1426)” should be replaced by –(1432)--, which is the element number for the translatable blocker shown in figures 50A-50B.
Appropriate correction is required.
Claim Interpretation - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 112
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 21-40 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. With respect to base claims 21, 35, and 36, a “shaft assembly” and a “replacement shaft assembly” are recited, so it is not definite whether the surgical instrument comprises one or both shaft assemblies. Also, it is not definite as to what the “blocker” is blocking. That is, what is the function of the “blocker”?
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)(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.
Claims 21-25, 29, and 30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Groene et al. (10,639,059). Groene et al. disclose, in figures 1, 2, and 9 and col. 6, line 64 to col. 7, line 32; col. 11, line 12 to col. 13, line 3; 21. a surgical instrument (e.g., 100), comprising:(a) a housing (104) configured to removably connect to a shaft assembly (106);(b) an ultrasonic transducer (102) supported by the housing and having a transducer connector configured to connect to a waveguide (an acoustic waveguide) for acoustically connecting the ultrasonic transducer to the waveguide, wherein the ultrasonic transducer is configured to be operated up to a predetermined number of use cycles; and (c) a switch usage indicator (112--generator) operatively connected to the housing and configured to move from a use remaining state to a used state when the ultrasonic transducer has been operated at least the predetermined number of use cycles, wherein the switch usage indicator includes:(i) a memory (EEPROM, according to col. 6, line 64 to col. 7, line 32) configured to detect and record each instance of connection to a replacement shaft assembly (i.e., the number of uses of a given shaft assembly),(ii) a blocker (a usage counter, according to col. 11, lines 16-21) operatively connected to the memory and configured to move from a use remaining position (a displayed notification, according to col. 12, lines 21-24) in the use remaining state to a used position (another displayed notification, according to col. 12, lines 24-29) in the used state when the memory detects and records removal of the replacement shaft assembly (i.e., when components of the instrument are replaced, according to col. 12, lines 5-14), and another associated with at least the predetermined number of use cycles, wherein the blocker in the used position is configured to indicate the used state to a clinician; wherein the switch usage indicator further includes a visual indicia (a displayed notification on display 118 or 918—a flashing LED, according to col. 12, lines 21-40) configured to move from a first indicator position (one displayed notification) in the use remaining state to a second indicator position (another displayed notification) in the used state; wherein the blocker in the use remaining position captures the visual indicia such that the indicator remains in the first indicator position for indicating the use remaining state to a clinician, and wherein blocker in the used position releases the visual indicia (i.e., gives a visual warning, according to col. 11, lines 50-53) such that the indicator moves to the second indicator position (a displayed notification controllable by a button, according to col. 11, lines 54-56)) for indicating the used state to the clinician; wherein the switch usage indicator in the used state is configured to inhibit use with the replacement shaft assembly (i.e., lockout mode, according to col. 12, lines 15-21); wherein the memory is configured to inhibit electrically powering the ultrasonic transducer with the switch usage indicator in the used state (i.e. when power is down or drained, according to col. 12, lines 37-40); wherein the switch usage indicator further includes an indicia (a displayed notification on display 118) configured to indicate the use remaining state and further configured to indicate the used state (another displayed notification on display 118); and wherein the indicia includes a visual indicia (e.g. flashing LED 918).
Allowable Subject Matter
Claims 26-28 and 31-34 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 35-40 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: With respect to claims 26-28 and 31-34, none of the prior art of record, alone or in combination, discloses a surgical instrument, comprising, inter alia:(a) a housing configured to removably connect to a shaft assembly;(b) an ultrasonic transducer supported by the housing and having a transducer connector configured to connect to a waveguide for acoustically connecting the ultrasonic transducer to the waveguide, wherein the ultrasonic transducer is configured to be operated up to a predetermined number of use cycles; and (c) a switch usage indicator operatively connected to the housing and configured to move from a use remaining state to a used state when the ultrasonic transducer has been operated at least the predetermined number of use cycles, wherein the switch usage indicator includes:(i) a memory configured to detect and record each instance of connection to a replacement shaft assembly,(ii) a blocker operatively connected to the memory and configured to move from a use remaining position in the use remaining state to a used position in the used state when the memory detects and records removal of the replacement shaft assembly associated with at least the predetermined number of use cycles, wherein the blocker in the used position is configured to inhibit connection of the ultrasonic transducer to the replacement shaft assembly, wherein the switch usage indicator further includes a biasing element operatively connected to the indicia and configured to selectively adjust the indicia from the use remaining state to the used state, wherein the blocker is configured to inhibit reconnection of the replacement shaft assembly with the ultrasonic transducer thereby indicating the used state to the clinician, or wherein the switch usage indicator is configured to inhibit reconnection of the replacement shaft assembly with the ultrasonic transducer thereby indicating the used state to the clinician.
With respect to base, independent claim 35, none of the prior art of record, alone or in combination, discloses a surgical instrument, comprising, inter alia:(a) a housing configured to removably connect to a shaft assembly or a replacement shaft assembly;(b) an ultrasonic transducer supported by the housing and having a transducer connector configured to connect to a waveguide for acoustically connecting the ultrasonic transducer to the waveguide, wherein the ultrasonic transducer is configured to be operated up to a predetermined number of use cycles; and (c) a switch usage indicator operatively connected to the housing and configured to move from a use remaining state to a used state when the ultrasonic transducer has been operated at least the predetermined number of use cycles, wherein the switch usage indicator includes:(i) a memory configured to detect and record each instance of connection to a replacement shaft assembly,(ii) a blocker configured to move from a use remaining position in the use remaining state to a used position in the used state, wherein the blocker in the used position is configured to inhibit connection of the ultrasonic transducer to the replacement shaft assembly, (iii) a memory operatively connected to an electromagnetic switch configured to generate an electromagnetic field, (iv) a first biasing element and a second biasing element, wherein the first biasing element and second biasing element exert opposing forces on the blocker, wherein the first biasing element biases the blocker into the use remaining state, wherein upon the memory detecting and recording removal of the replacement shaft assembly associated with at least the predetermined number of use cycles, the memory is configured to signal the electromagnetic switch to generate the electromagnetic field, and wherein the electromagnetic field and the second biasing element constructively exert sufficient force on the blocker to overcome the force of the first biasing element to move the blocker into the used position in the used state.
With respect to base, independent claim 36, none of the prior art of record, alone or in combination, discloses a method for indicating a used state of a surgical instrument, the surgical instrument including: (a) a housing configured to removably connect to a shaft assembly or a replacement shaft assembly, (b) an ultrasonic transducer supported by the housing and having a transducer connector configured to connect to a waveguide for acoustically connecting the ultrasonic transducer to the waveguide, wherein the ultrasonic transducer is configured to be operated up to a predetermined number of use cycles, and (c) a switch usage indicator operatively connected to the housing and configured to move from a use remaining state to a used state when the ultrasonic transducer has been operated at least the predetermined number of use cycles, the method comprising, inter alia: connecting the shaft assembly or a replacement shaft assembly to the housing and detecting and recording each instance of connection to a replacement shaft assembly with a memory; wherein a blocker is moved from a use remaining position in the use remaining state to a used position in the used state when the memory detects and records removal of the replacement shaft assembly associated with at least the predetermined number of use cycles, and wherein the blocker in the used position is configured to inhibit connection of the ultrasonic transducer to the replacement shaft assembly.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Baber et al. (2016/0066910) teach a surgical instrument.
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/JULIAN W WOO/Primary Examiner, Art Unit 3771