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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/15/2024 and 02/21/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
Regarding claim 1 it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. The use “for guiding” in claim 1 is seen as intended use and therefore is given limited patentable weight and the prior art used would be capable of performing the “for guiding” function based on structure).
The examiner recommends that this language be amended to, “configured to guide.”
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: the terms “Controls unit configured to” in claim 1, “control unit comprises,” “control unit is configured to” in claim 2, and “control unit is configured to” in claim 4.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification paragraph [0030] page 6 lines 28-34 shows that “controls unit” in claim 1 and “control unit” in claim 2 both of which refer to part (22) is only broadly referred to as the automatic start/stop control unit. Additionally, there is no software associated with the mentioned hardware which allows the control unit to infer whether the smoke is present according to the working status of the energy instrument. For the purpose of examination, the examiner is interpreting the “control unit” to be the sensing mechanism.
A review of the specification paragraph [0033] page 7 lines 19-22 shows that “control unit” in claim 2 and claim 4 both of which refer to part (222) is also only broadly referred to as control unit. Additionally, there is no software associated with the mentioned hardware which allows the control unit to control the smoke exhaust host to perform synchronous start or intermittent stat at a predetermined time according to the magnitude of the real-time working power of the energy instrument. For the purpose of examination, the examiner is interpreting the “control unit” to be the controller.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim limitation “Controls unit configured to” in claim 1 invokes 112(f); however, it appears to a computer implemented means. There is no software associated with hardware in the originally filed disclosure or the specification. Therefore this is seen as lacking written description. In applicants’ specification, page 7 lines 19-22, merely just states the element as a control unit. For examination purposes, this is seen as a controller.
Claims 2 and 4 are similarly rejected as the claim limitations “control unit comprises,” and “control unit is configured to” invoke 112(f) and there is no description within the specification of what these elements are.
Claims 3 and 5-10 are similarly rejected due to their dependency.
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 1-10 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.
Claims 1-2 and 4 recite the limitations “Controls unit configured to” and “control unit configured to…” has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the control unit is identified as the structure for performing the function of configuring, but it is not sufficient to perform the function and no other structure for performing the function has been identified. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Regarding claims 3, 5-10, the claims are also seen as indefinite as they inherit the deficiencies of the independent claim 1.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, IV et al (US20190201083A1) herein referred to as “Shelton” in view of Wolter (US20190350640A1) herein referred to as “Wolter”
Regarding claim 1, Shelton discloses: A surgical smoke exhaust system, (FIG 7, see below, [0016] entire surgical evacuation system) comprising: a smoke exhaust channel; ( [0178] suction conduit is smoke exhaust channel FIG 2, see below, piece 50036) and a surgical smoke exhaust device, for guiding smoke generated by an energy instrument at a surgical site, to the surgical smoke exhaust device; (FIG 5, see below, [0178] the evacuator system comprising the housing, generator, and sensors, and [0193] evacuation system can include sensing and intelligent controls device) wherein the surgical smoke exhaust device comprises: a smoke exhaust host; ([0179] evacuator housing piece FIG 1 50018 and see FIG 8 below which displays point of connection) and a start or stop control unit electrically connected to the smoke exhaust host; ([0193] and [0200] sensing and intelligent controls device corresponding to the control unit; FIG 7 50640 (generator) and 50642 (electrical connection) to the evacuator housing FIG 7 50618) wherein the smoke exhaust channel is connected to the smoke exhaust host by means of a pipeline; ([0181] The inlet port can be fluidically coupled to a suction conduit, such as the suction conduit see FIG 7 50636) and wherein the start or stop controls unit is configured to: detect a working status of the energy instrument; ([0189 and 0193] processor can determine whether to adjust the output power level; FIG 5 sensing and control unit 50324 connected to external sensors 50332) and control start or stop of the smoke exhaust host based on working status information. ([200] demonstrates sensors found in the sensing intelligent control unit can be used to control the operation). However, Shelton does not explicitly disclose that the surgical smoke exhaust system is automatic or has an automatic start or stop control unit.
Wolter discloses: an automatic surgical smoke exhaust system and an automatic start or stop control unit ([0008] can activate or deactivate the system automatically).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the smoke exhaust system and start or stop control unit as disclosed in Shelton to be automatic as disclosed in Wolter. The motivation for this being the omission of additional work or handling steps which are required for manual activation. (Wolter [0008])
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Regarding claim 2 Shelton in view of Wolter discloses: The automatic surgical smoke exhaust system according to claim 1. Shelton further discloses: wherein the automatic start or stop control unit comprises a working status collecting unit and a control unit, (Shelton [0192] sensing and intelligent controls device located together within the evacuation system see FIG 5 above) wherein the control unit is configured to: analyze the working status information fed back from the working status collecting unit; (Shelton [0200] sensor information from the control unit is analyzed and then the generator activation is controlled accordingly) and control the start or stop of the smoke exhaust host. (Shelton [0199] adjusting the rate of the pump’s revolution, RPM (which can go from 0 to 100), interpreted as on for anything greater than 0 and off for 0, hence the start/stop is controlled by adjusting the RPM)
Regarding claim 3 Shelton in view of Wolter discloses: The automatic surgical smoke exhaust system according to claim 1, wherein the energy instrument is inserted into the smoke exhaust channel(Shelton; see FIG 7 above; electrosurgical instrument 50630 seen inserted between conduit opening 50634 ) and wherein a working end of the energy instrument extends out of the smoke exhaust channel. (Shelton; see FIG 7 above; electrosurgical instrument 50630 at the end of the suction hose 50636 all of which are connected to the filter end cap 50603)
Regarding claim 4 Shelton in view of Wolter discloses: The automatic surgical smoke exhaust system according to claim 2. Shelton further discloses: wherein the working status collecting unit is electrically connected between an energy generator and a power supply (Shelton [0192] and FIG 5 seen above, the smoke evacuator sensors are seen to be electrically connected between the power converter acting as a generator and the AC source) and wherein the control unit is configured to determine the working status of the energy instrument based on transmission power between the power supply and the energy generator. (Shelton [0189] sensors are used to detect voltage and current and the output power which is connected to the generator, is adjusted accordingly)
Regarding claim 6 Shelton in view of Wolter discloses: The automatic surgical smoke exhaust system according to claim 4. However, Shelton does not explicitly disclose wherein the working status collecting unit is an acoustic sensor, and wherein the working status collecting unit is configured to detect sound waves intermittently emitted, by the energy generator, according to a magnitude of output energy power of the energy generator.
Wolter discloses: wherein the working status collecting unit is an acoustic sensor, ([0030] describes an acoustic sensor) and wherein the working status collecting unit is configured to detect sound waves intermittently emitted, by the energy generator, according to a magnitude of output energy power of the energy generator. (Wolter [0031] describes a tone output by the generator which is an example of a sound wave [0030] states the sensor is configured to detect a repetition and during a defined time period which suggests the sound waves are intermittently emitted and [0077] a predefined frequency tolerance shows the sensor can only detect a certain magnitude of the acoustic signal)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the working status as disclosed in Shelton to include an acoustic sensor as disclosed in Wolter. The motivation being that acoustic sensing allows smoke to be automatically removed by means of suction in one or several frequency ranges which may increase the reliability (Wolter [0078])
Regarding claim 7 Shelton in view of Wolter discloses: The automatic surgical smoke exhaust system according to claim 4. Shelton further discloses: wherein the working status collecting unit is a light color recognition module, (Shelton [0262] uses a photoelectric sensor) and configured to detect light of different colors emitted by a light-emitting unit on the energy generator, (Shelton [0264] can detect different wavelengths of the light which is equivalate to saying different colors as each color has a different wavelength) wherein the different colors indicate different magnitudes of output energy power of the energy generator; (Shelton [0263] the absorption properties, which constitute different magnitudes of the output energy, is recorded; [0262] this information from the photoelectric sensor is analyzed and used to control the energy generator) or the working status collecting unit is a light intensity recognition module (Shelton [0263] photoelectric sensor configured to detect intensity of light) and configured to, detect indicator light of different levels of brightness emitted by the light-emitting unit on the energy generator (Shelton [0263] intensity of the light equates to the respective levels of “brightness”) wherein the different levels of brightness indicate different magnitudes of the output energy power of the energy generator (Shelton [0263] the output signal is provided to the processor which can then determine the operational parameter of the motor based electrical signal)
Regarding claim 8 Shelton in view of Wolter discloses: The automatic surgical smoke exhaust system according to claim 4. Shelton further discloses: wherein the working status collecting unit is a temperature sensor and, configured to recognize a temperature at an acting area, at the surgical site, where the energy instrument works. (Shelton [0237] temperature sensor detects the temperature at the surgical site)
Regarding claim 9 Shelton in view of Wolter discloses: The automatic surgical smoke exhaust system according to claim 4. Shelton further discloses: wherein the working status collecting unit is a smoke sensor and, configured to recognize a concentration of the smoke generated, by the energy instrument, at the surgical site. (Shelton [256] a particle sensor which acts as the smoke sensor to determine the concentration of the smoke)
Regarding claim 10 Shelton in view of Wolter discloses: The automatic surgical smoke exhaust system according to claim 2. Shelton further discloses: wherein the working status collecting unit comprises an image acquisition device and an image display device, wherein the image acquisition device is configured to capture the surgical site, and wherein the control unit is embedded with an image processing module and configured to recognize smoke in a picture captured by the image acquisition device. (Shelton [0360] and [0199] camera scope for image acquisition and smoke recognition [0368] contains an image display device. See FIG 30 below; image processing module embedded within same system as the control unit, that is, within the evacuator housing)
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Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Wolter in further view of Lizauckas et al (US20170245908A1) herein referred to as “Lizauckas”
Regarding claim 5 Shelton in view of Wolter discloses: The automatic surgical smoke exhaust system according to claim 4. However, Shelton in view of Wolter does not explicitly disclose: wherein the working status collecting unit is a Hall sensor.
Lizauckas discloses: wherein the working status collecting unit is a Hall sensor. ([0035] discusses a hall sensor coupled to an electrosurgical device and operating within a feedback loop and uses this information to adjust the on or off state of the valve)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor of the working status collection unit as disclosed in Shelton in view of Wolter to include a Hall sensor as disclosed in Lizauckas. The motivation to do so being that these sensors can operate without direct contact (Lizauckas [0035]). Additionally, it would have been obvious to try and implement either a sensor that is in direct contact or one that is not required to be in direct contact since these are the only types of sensors to exist, hence, the options are finite (MPEP § 2143 (E)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M GANAN-SINGH whose telephone number is (571)272-3194. The examiner can normally be reached Monday to Friday 7:30am to 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.G.S/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794