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 amendments filed 04/30/2025 have been entered. Claims 1 and 8 have been amended. Claims 1-14 are pending on the application.
Response to Arguments
Applicant's arguments filed 04/30/2025 have been considered but are not persuasive.
Applicant argues that Falkenstein (US 20090248022 A1) fails to explicitly disclose “a plurality of parameterized references referring to operating specifications stored in the generator data memory”. However, Falkenstein discloses in par [0198] “Based on the recognized tool, the generator accesses and initiates specific operations and setting parameters utilized to configure the controller to properly apply RF energy as desired by the tool”. Thus the references from the tool refer to operating specifications in the generator. As such, Applicant’s argument is not persuasive.
Additionally, Applicant has amended independent claims 1 and 8 to further include the limitation “wherein the operating program stored in the generator data memory is stored independently of the operating specifications in the generator data memory, and the operating specifications are stored independently of the structured data in the data structure (due to the nature of structured data and how it is stored in memory, all data is stored “independently” by broadest reasonable interpretation because changing one value will not affect any other stored values),
and wherein when an electrosurgical instrument is connected to the electrosurgical generator, the electrosurgical generator reads the instrument data memory in the electrosurgical instrument and calls up the operating specifications in the generator data memory that are designated by the references contained in the structured data (Falkenstein par [0261] electrosurgical tool includes memory having commands and parameters that dictate the operation of the tool in conjunction with the electrosurgical generator),
so that the current and voltage curves including any timing requirements and other conditions defined in those operating specifications are applied (Falkenstein Fig 23 shows voltage and current curves applied, par [0269] operating specifications include voltage, current etc.).”
However, due to the nature of structured data and how it is stored in memory, all data is stored “independently” by broadest reasonable interpretation because changing one value will not affect any other stored values. Furthermore, Falkenstein discloses how the electrosurgical generator reads the instrument data memory in order to apply the voltage and current and timing requirements (see, e.g., Falkenstein par [0268-269] the controller has a specific or predetermined fixed tool script for a specific input receptacle… The script controls the voltage and current output settings as well as sequences of voltage and current settings). Thus, the Applicant’s argument is not persuasive.
Claim Interpretation
Due to the Specification not giving a specific definition of the term “structured data”, the definition known in the art will be used for claim interpretation. Structured data is data that has been organized into a formatted repository, typically a database. Structured data is data that has a standardized format for efficient access by software and humans alike.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 6, 8, and 12-14 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites a method comprising:
providing a data set containing structured data representing references to the operating specifications, wherein, in the structured data, a reference to one of the operating specifications representing a control command followed by the parameters that parameterize the one of the control commands are sequentially arranged, the structured data being implemented as a plurality of parameterized references referring to operating specifications (this is a mental process of merely providing data);
storing the data set with structured data (mere manipulation of data);
executing, an operating program (mere manipulation of data);
reading the data set with structured data when the electrosurgical generator is started up or during its operation (mere reading of data);
selecting the parameterized references stored in the structured data under the control of the operating program (mere manipulation of data);
executing the control commands in accordance with the operating parameters that are available in the structured data, so that the electrosurgical generator is controlled based on all of the following: the operating program, the operating specifications, and the parameterized references to individual ones of the control commands which are contained in the structured data (at such a high level of generality, such an electrosurgical generator may be operated by hand based on data),
reading the instrument data memory (mere manipulation of data),
calling up the operating specifications in the generator data memory that are designated by the references contained in the structured data (mere manipulation of data).
This judicial exception is not integrated into a practical application because there is no application beyond “controlling an electrosurgical generator”, at an extremely high level of generality, which could simply comprise turning such a generator on and off by hand. It is recommended that the applicant make clear in the claims what practical application the instant invention has. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of “an electrosurgical instrument”, “an electrosurgical generator”, “a processor” and memory which can store instructions, are all recited at a very high level of generality and are all very common elements in the art.
Applicant is encouraged to overcome this rejection by reciting non-generic additional elements and by integrating the judicial exception into a practical application.
Claim 2 rejected for failing to integrate the invention of claim 1 into either a practical application or provide additional elements which amount to significantly more than the judicial exception. Claim 2 recites the method according to claim 1, wherein after being read by the electrosurgical generator, the data set with structured data stored in the instrument data memory of the electrosurgical instrument is stored in the generator data memory of said electrosurgical generator (mental process of moving/storing data).
Claim 3 rejected for failing to integrate the invention of claim 1 into either a practical application or provide additional elements which amount to significantly more than the judicial exception. Claim 3 recites the method according to claim 1, wherein the structured data stored in the instrument data memory of the electrosurgical instrument is changed when it is being read by the electrosurgical generator or after it has been stored in the generator data memory of the electrosurgical generator (mental process of altering data).
Claim 6 rejected for failing to integrate the invention of claim 1 into either a practical application or provide additional elements which amount to significantly more than the judicial exception. Claim 6 recites the method according to claim 1, wherein the structured data comprises conditions and characteristics for generation and/or display of notifications and/or error messages (mental process of selecting data).
Claim 8 rejected for the same reasons as Claim 1 above.
Claim 12 rejected for failing to integrate the invention of claim 8 into either a practical application or provide additional elements which amount to significantly more than the judicial exception. Claim 12 recites the method according to claim 8, with one programming interface or several programming interfaces (generic I/O data structure common in the art), by means of which content of the generator data memory and of the data structure can be programmed (mental process of entering or changing data).
Claim 13 rejected for failing to integrate the invention of claim 1 into either a practical application or provide additional elements which amount to significantly more than the judicial exception. Claim 13 recites the method according to claim 1, further comprising: providing instrument data memory containing data sets with structured data representing signaling instructions for acoustic and/or optical signals to be emitted by an electrosurgical generator during operation (mental process of providing data; no practical application since no structure for acoustic and/or optical signals to be emitted is recited).
Claim 14 rejected for failing to integrate the invention of claim 1 into either a practical application or provide additional elements which amount to significantly more than the judicial exception. Claim 14 recites the method according to claim 1, further comprising: creating a structured data set for the electrosurgical instrument (mental process of creating data);
providing a programming interface (generic I/O data structure common in the art),
creating a data set with structured data that is implemented as a plurality of parameterized references using the programming interface (mental process of creating data), and
storing the data set in the instrument data memory of the electrosurgical instrument (mental process of storing data).
Applicant is encouraged to overcome these rejection by reciting non-generic additional elements and by integrating the judicial exception into a practical application, such as is the case for claims 4-5, 7, and 9-11.
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 1-14 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.
Claim 1 recites the limitation " the current and voltage curves" in line 40-41 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-7 inherit the deficiencies of claim 1 but do not ameliorate them.
Claim 8 recites the limitation " the current and voltage curves" in line 25-26 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 9-14 inherit the deficiencies of claim 8 but do not ameliorate them.
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.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Falkenstein (US 20090248022 A1).
Regarding Claim 1, Falkenstein discloses
A method of operating an electrosurgical system, the electrosurgical system comprising:
an electrosurgical instrument that has at least one instrument data memory (Falkenstein Fig 1A instrument (40) memory (70) par [0163]);
and an electrosurgical generator connected to the electrosurgical instrument during operation, the electrosurgical generator including a processor and at least one generator data memory connected to the processor (Falkenstein Fig 1A generator (10,80) processor (80) par [0179]; par [0266] generator has memory),
said generator data memory comprising operating specifications that comprise potentially applicable control commands and may comprise additional operating parameter values (Falkenstein par [0264] generator script has commands and parameters for tool operation);
the method comprising:
providing a data set containing structured data representing references to the operating specifications stored in the generator data memory of the electrosurgical generator (Falkenstein par [0198]);
wherein, in the structured data, a reference to one of the operating specifications representing a control command followed by the parameters that parameterize the one of the control commands are sequentially arranged (Falkenstein par [0275] control commands associated with specific parameters),
the structured data being implemented as a plurality of parameterized references referring to operating specifications stored in the generator data memory of the electrosurgical generator (Falkenstein par [0268] operating specifications stored in generator);
storing the data set with structured data in the instrument data memory of the electrosurgical instrument (Falkenstein par [0264]);
executing, using the processor, an operating program stored in the generator data memory (Falkenstein par [0264]);
reading the data set with structured data stored in the instrument data memory of the electrosurgical instrument by the electrosurgical generator when the electrosurgical generator is started up or during its operation (Falkenstein par [0264]);
selecting the parameterized references stored in the structured data under the control of the operating program (Falkenstein par [0269] selecting appropriate parameters);
executing the control commands stored in the electrosurgical generator in accordance with the operating parameters that are available in the structured data (Falkenstein par [0264]), so that the electrosurgical generator is controlled based on all of the following:
the operating program, the operating specifications stored in the generator data memory (Falkenstein par [0264] program and specifications stored in generator), and
the parameterized references to individual ones of the control commands stored in the generator data memory which are contained in the structured data (Falkenstein par [0265] data for specific procedure stored on tool),
wherein the operating program stored in the generator data memory is stored independently of the operating specifications in the generator data memory, and the operating specifications are stored independently of the structured data in the data structure (due to the nature of structured data and how it is stored in memory, all data is stored “independently” by broadest reasonable interpretation because changing one value will not affect any other stored values),
and wherein when an electrosurgical instrument is connected to the electrosurgical generator, the electrosurgical generator reads the instrument data memory in the electrosurgical instrument and calls up the operating specifications in the generator data memory that are designated by the references contained in the structured data (Falkenstein par [0261] electrosurgical tool includes memory having commands and parameters that dictate the operation of the tool in conjunction with the electrosurgical generator),
so that the current and voltage curves including any timing requirements and other conditions defined in those operating specifications are applied (Falkenstein Fig 23 shows voltage and current curves applied, par [0269] operating specifications include voltage, current etc.).
Regarding Claim 2, Falkenstein discloses the method of claim 1. Falkenstein further discloses wherein after being read by the electrosurgical generator, the data set with structured data stored in the instrument data memory of the electrosurgical instrument is stored in the generator data memory of said electrosurgical generator (Falkenstein par [0266] generator stores data from tool after reading it).
Regarding Claim 3, Falkenstein discloses the method of claim 1. Falkenstein further discloses wherein the structured data stored in the instrument data memory of the electrosurgical instrument is changed when it is being read by the electrosurgical generator or after it has been stored in the generator data memory of the electrosurgical generator (Falkenstein par [0269] changes may be made to parameters during operation, which is after or during being read by generator, see par [0275]).
Regarding Claim 4, Falkenstein discloses the method of claim 1. Falkenstein further discloses wherein the structured data comprises signaling instructions that are converted into configuration and/or operating status-dependent acoustic and/or visual notifications to a user during the operation of the electrosurgical generator (Falkenstein Fig 1A indicator (42) par [0160]; par [0199] audio or visual output to provide operating status).
Regarding Claim 5, Falkenstein discloses the method of claim 1. Falkenstein further discloses wherein the structured data comprises a byte sequence for defining activation sounds (Falkenstein par [199] activation tone).
Falkenstein fails to explicitly disclose wherein the structured data comprises a byte sequence for defining activation sounds. However, all data is stored in bytes, and thus any data storing definitions for activation sounds would have to store it as a byte sequence due to the nature of data storage.
Regarding Claim 6, Falkenstein discloses the method of claim 1. Falkenstein further discloses wherein the structured data comprises conditions and characteristics for generation and/or display of notifications and/or error messages (Falkenstein par [0265] procedure data is stored on tool; par [0278] procedure data can cause notification depending on procedure type).
Regarding Claim 7, Falkenstein discloses the method of claim 1. Falkenstein further discloses wherein the structured data comprises control characters for data representing text notifications, wherein the control characters define a display of text notifications on various displays, and in that text notifications are generated during the operation of the electrosurgical generator in dependence on the control characters and a display for text present at the electrosurgical generator (Falkenstein Fig 4 various displays (420) has text notifications indicating parameters defined by data on tool par [0176]).
Regarding Claim 8, Falkenstein discloses all the limitations of claim 8, as seen in the rejection of claim 1 above.
Regarding Claim 9, Falkenstein discloses the system of claim 8. Falkenstein further discloses where the electrosurgical generator has a sound generator and a loudspeaker connected to the sound generator for output of acoustic signals, wherein the sound generator is operatively connected to the processor and configured to generate acoustic signals and to output them via the loudspeaker under the control of the processor in dependence on data in the instrument data memory of the electrosurgical instrument which represents signaling instructions (Falkenstein Fig 3 generator (410) par [0174] generator may have speaker with different sounds based on different procedures; par [0261] procedure data provided by tool).
Regarding Claim 10, Falkenstein discloses the system of claim 9. Falkenstein further discloses where audio files that the sound generator can convert into acoustic signals under the control of the processor and the operating program in dependence on data in the instrument data memory of the electrosurgical instrument which represents signaling instructions are stored in the generator data memory (Falkenstein par [0174] generator may have speaker with different sounds based on different procedures; par [0261] procedure data provided by tool; par [0275] files to operate generator transferred from tool to generator memory).
Regarding Claim 11, Falkenstein discloses the system of claim 8. Falkenstein further discloses where the electrosurgical generator has a display for displaying text and/or symbols, which is connected to the processor and configured to output text notifications under the control of the processor and the operating program in dependence on data in the instrument data memory of the electrosurgical instrument which represents signaling instructions (Falkenstein Fig 4 various displays (420) has text notifications indicating parameters defined by data on tool par [0176]).
Regarding Claim 12, Falkenstein discloses the system of claim 8. Falkenstein further discloses with one programming interface or several programming interfaces, by means of which content of the generator data memory and of the data structure can be programmed (Falkenstein par [0196]).
Regarding Claim 13, Falkenstein discloses the method of claim 1. Falkenstein further discloses providing instrument data memory containing data sets with structured data representing signaling instructions for acoustic and/or optical signals to be emitted by an electrosurgical generator during operation (Falkenstein Fig 4 various displays (420) has text notifications caused by data on tool, par [0176]).
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Falkenstein (US 20090248022 A1) in view of Wham (US 20050004564 A1).
Regarding Claim 14, Falkenstein discloses the method of claim 1. Falkenstein further discloses creating a structured data set for the electrosurgical instrument;
providing a programming interface (Falkenstein par [0196]),
creating a data set with structured data that is implemented as a plurality of parameterized references (Falkenstein par [0265]), and
storing the data set in the instrument data memory of the electrosurgical instrument (Falkenstein par [00265]).
Falkenstein fails to explicitly disclose creating the data set with structured data that is implemented as a plurality of parameterized references using the programming interface.
However, Wham discloses a similar method and system for programming and controlling an electrosurgical generator system comprising a user interface used for programming (Wham, par [0024] programming performed based on user input device), as well as creating a data set with structured data that is implemented as a plurality of parameterized references (Wham, par [0032] creating data set with structured data as a plurality of parameterized references).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Falkenstein with programming and interface such as disclosed by Wham so as to be able to modify instrument data, as this setup allows for easy changing to instrument parameters during operation (Wham, par [0025]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shelton (US 20190206564 A1), McHenry (US 20160310204 A1), Scheib (US 20170105782 A1), Shelton2 (US 20190201082 A1), and Nguyen (US 20200069358 A1) disclose similar methods and systems of electrosurgical generator control comprising explicit structured data organization and usage. It is recommended that applicant thoroughly examine these materials so as to ensure novelty over the prior art.
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 Matthew Becton whose telephone number is (571)272-9570. The examiner can normally be reached Monday-Friday 9am-5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW DAVID BECTON/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794