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 .
Notice to Applicants
This action is in response to the Application filed on 09/06/2023.
Claims 1-16 are pending.
Priority
The Application claims priority to Provisional Application 63/413,485 with filing date 10/05/2022, which is acknowledged.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 10/31/2023 has been fully considered by the examiner.
Claim Interpretation
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 limitation(s) is/are:
“Electrosurgical signal generation unit”, present in claims 1 and 10, with corresponding structure found in at least figure 1 and page 4, line 10 to page 5, line 4 of the originally filed specification,
“Instrument detection unit”, present in claim 1, with corresponding structure found in at least figure 3, as well as page 5, line 19 to page 6, line 2, as well as page 7, lines 27-32 of the originally filed specification,
“Image processor”, present in claims 1, 4, and 10, with corresponding structure found in at least figure 3 and page 7, lines 1-10 of the originally filed specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) 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 it/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 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.
Claim 8 is 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.
Regarding claim 8, line 2 recites “wherein the processor is configured to select a database entry from the database” (emphasis added). There is no antecedent basis for the term “the database” in claim 8.
This issue arose because claim 8 originally depended upon claims 6 and 7, but claim 8 was amended to depend only upon claim 6, which does not recite a database. One suggestion is to thus cancel claim 7 and incorporate its elements into claim 8, as claim 8 needs the elements of both claims 6 and 7 to avoid antecedent basis issues.
Another suggestion would be to amend claim 8 to read “wherein the processor is configured to select a database entry from a database” (emphasis added).
35 USC § 101 Analysis
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.
The examiner has determined that all of claims 1-16 are eligible under 35 U.S.C. 101. The 101 analysis is provided below for the purpose of a clear record.
Analysis for claim 1 is provided in the following. Claim 1 is reproduced in the following (annotation added):
An electrosurgical generator, comprising:
- at least one interface for connecting an electrosurgical instrument to the electrosurgical generator;
- an electrosurgical signal generation unit for supplying an electrosurgical signal to an electrosurgical instrument connected to the electrosurgical generator;
- a processor configured to control the electrosurgical signal generation unit; and
- an instrument detection unit configured to detect the type of an electrosurgical instrument connected to the electrosurgical generator;
wherein the instrument detection unit comprises a camera and an image processor,
the camera being configured to acquire one or more images of an electrosurgical instrument connected to the electrosurgical generator,
and the image processor being configured to analyse the one or more images to detect the type of the electrosurgical instrument;
and wherein the processor is configured to control the electrosurgical signal generation unit depending on the detected type of the electrosurgical instrument.
Step 1: Does the claim belong to one of the statutory categories? Claim 1 is directed to a machine, which is a statutory category of invention (YES).
Step 2A Prong One: Does the claim recite a judicial exception? Part e recites detection of a type of an electrosurgical instrument connected to the electrosurgical generator. Part h recites analyzing images to detect the type of the electrosurgical instrument, both of which are mental processes including observations, evaluations, judgements, or opinions that can be practically performed in the human mind (YES).
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? Parts a, b, and c recite a particular machine that performs and uses the results of the mental processes. Part i recites controlling the electrosurgical signal generation unit depending on the detected type of the instrument, which reflects the improvements discussed in at least pages 1-2 and page 5, lines 11-18 of the originally filed specification. Such improvements are directed to increasing the range and accuracy of detecting compatibility between the generator and the instruments before using the instruments in medical/surgical settings, such that the generator can be controlled to output proper waveforms or therapy signals to the instruments during their use (YES). Claim 1 is eligible.
Claim 10 recites similar limitations to claim 1 above. Claim 10 is eligible as applied to claim 1 above.
Claims 2-3, 7, 9, 11, and 16 recite additional elements with no new judicial exceptions. Claims 2-3, 7, 9, 11, and 16 are eligible.
Claims 4-6 and 12-14 narrow the mental processes recited in claim 1. However, they are still integrated into a practical application as applied to claim 1 above. Claims 4-6 and 12-14 are eligible.
Claims 8 and 15 recite selecting a database entry using the detected instrument features, and reading one or more parameters of an electrosurgical therapy signal from the selected database entry, both of which are mental processes that can be practically performed in the human mind. However, claims 8 and 15 depend upon claim 1, which integrates these features into a practical application. Claims 8 and 15 are eligible.
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)(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, 4, 6-7, 9-10, 12, 14, and 16 are rejected under 35 USC 102(a)(1) and 102(a)(2) as being anticipated by Shelton et al. (U.S. Publ. US-2019/0201129-A1).
Regarding claim 1, Shelton discloses an electrosurgical generator (see figure 10, surgical hub 206, which includes generator module 240, and paragraphs 0246-0247; paragraphs 0286 and 0288 specify that the generator can be an electrosurgical generator), comprising:
- at least one interface for connecting an electrosurgical instrument to the electrosurgical generator (see figure 5 and paragraph 0216, where monopolar, bipolar, or ultrasonic instruments can connect to the generator);
- an electrosurgical signal generation unit for supplying an electrosurgical signal to an electrosurgical instrument connected to the electrosurgical generator (see paragraph 0210, where the generator module includes ultrasonic, bipolar RF, or monopolar RF generator components that deliver energy to electrosurgical instruments through delivery cables);
- a processor configured to control the electrosurgical signal generation unit (see figure 10, processor module 244 and paragraph 0317, where the processor can control the generator to change the amount of energy it supplies); and
- an instrument detection unit configured to detect the type of an electrosurgical instrument connected to the electrosurgical generator (see figure 17A and paragraph 0314);
wherein the instrument detection unit comprises a camera (see figure 16, cameras 211802) and an image processor (see figure 10, processor 244 and paragraph 0314),
the camera being configured to acquire one or more images of an electrosurgical instrument connected to the electrosurgical generator (see figure 17A, step 211602, as well as figure 16 and paragraph 0313, where the cameras 211802 are oriented to obtain images of an operating room 211800, including images of surgical staff members 211803 and surgical instruments 211810),
and the image processor being configured to analyse the one or more images to detect the type of the electrosurgical instrument (see figure 17A, step 211604 and paragraph 0313, where the image or video data can be analyzed to track characteristics or properties of surgical staff members and surgical instruments);
and wherein the processor is configured to control the electrosurgical signal generation unit depending on the detected type of the electrosurgical instrument (see figure 17A, step 211606 and paragraph 0317, where the processor can control the energy output of the generator supplying the instrument depending on the characteristics of the identified instrument; see paragraph 0274, where specific types of instruments can be blacklisted from connecting to the surgical hub and generator).
Regarding claim 4, Shelton discloses wherein the image processor is configured to apply an instrument recognition algorithm on the one or more images acquired by the camera (see paragraph 0315, where a variety of image or object recognition techniques, including appearance and feature-based techniques, can be used to recognize surgical staff and surgical devices from the images).
Regarding claim 6, Shelton discloses wherein the instrument recognition algorithm comprises a feature extraction step (see paragraph 0315, where an algorithm can extract features from the images and feed them into a machine learning model).
Regarding claim 7, Shelton discloses further comprising a database (see figure 7, aggregated medical data database 7011 and paragraph 0266).
Regarding claim 9, Shelton discloses wherein the instrument recognition algorithm uses artificial intelligence (AI) or machine learning (ML) (see paragraph 0315).
Regarding claim 10, Shelton discloses a method of operating an electrosurgical generator according to claim 1, with the steps:
- connecting an electrosurgical instrument to the electrosurgical generator (see figure 5 and paragraph 0216, where monopolar, bipolar, or ultrasonic instruments can connect to the generator);
- acquiring, through the camera of the electrosurgical generator, one or more images of the electrosurgical instrument (see figure 17A, step 211602, as well as figure 16 and paragraph 0313, where the cameras 211802 are oriented to obtain images of an operating room 211800, including images of surgical staff members 211803 and surgical instruments 211810);
- analysing, through the image processor, the one or more images;
- detecting, through the image processor, the type of the electrosurgical instrument (see figure 17A, step 211604 and paragraph 0313, where the image or video data can be analyzed to track characteristics or properties of surgical staff members and surgical instruments); and
- controlling, through the processor, the electrosurgical signal generation unit depending on the detected type of the electrosurgical instrument (see figure 17A, step 211606 and paragraph 0317, where the processor can control the energy output of the generator supplying the instrument depending on the characteristics of the identified instrument; see paragraph 0274, where specific types of instruments can be blacklisted from connecting to the surgical hub and generator).
Regarding claim 12, Shelton discloses claim 12 as applied to claim 4 above.
Regarding claim 14, Shelton discloses claim 14 as applied to claim 6 above.
Regarding claim 16, Shelton discloses claim 16 as applied to claim 9 above.
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 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton et al. (U.S. Publ. US-2019/0201129-A1) in view of Meglan et al. (U.S. Publ. US-2022/0304555-A1).
Regarding claim 2, Shelton fails to disclose the limitations of claim 2.
Pertaining to the same field of endeavor, Meglan discloses wherein the camera is configured to acquire one or more 3D images of the electrosurgical instrument (see figure 5, steps 502-506 and paragraphs 0071-0073, where a stereographic image of a surgical site including a surgical instrument is obtained and analyzed to determine depth information; see figure 9, object 908 and paragraph 0088, where a stereographic image of a bipolar grasper is obtained).
Shelton and Meglan are considered analogous art, as they are both directed to detection of electrosurgical instruments from images. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Meglan into Shelton because the depth information can be input to a neural network to enable improved object detection and classification (see Meglan paragraphs 0074-0077).
Regarding claim 11, Shelton in view of Meglan discloses claim 11 as applied to claim 2 above.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Shelton et al. (U.S. Publ. US-2019/0201129-A1) in view of Meglan et al. (U.S. Publ. US-2022/0304555-A1), and further in view of Kristensen et al. (U.S. Publ. US-2023/0346211-A1).
Regarding claim 3, Shelton in view of Meglan fails to disclose the limitations of claim 3.
Pertaining to the same field of endeavor, Kristensen discloses wherein the camera is a time-of-flight (TOF) camera (see paragraph 0030).
Shelton and Kristensen are considered analogous art, as they are both directed to detection of objects in surgical images. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Kristensen into Shelton and Meglan because doing so enables determination of distances to objects in surgical sites (see paragraph 0030).
Claims 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton et al. (U.S. Publ. US-2019/0201129-A1) in view of Seo (U.S. Publ. US-2014/0276940-A1).
Regarding claim 5, Shelton fails to disclose the limitations of claim 5.
Pertaining to the same field of endeavor, Seo discloses wherein the instrument recognition algorithm comprises an object separation step (see paragraphs 0067-0069, where a surgical tool is separated from the backgrounds of images).
Shelton and Seo are considered analogous art, as they are both directed to detection of surgical instruments from images. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Seo into Shelton because doing so improves position and direction estimation of surgical tools in images (see Seo paragraphs 0068-0069).
Regarding claim 13, Shelton in view of Seo discloses claim 13 as applied to claim 5 above.
Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton et al. (U.S. Publ. US-2019/0201129-A1) in view of Swayze et al. (U.S. Publ. US-2018/0168733-A1).
Regarding claim 8, Shelton fails to disclose the limitations of claim 8.
Pertaining to the same field of endeavor, Swayze discloses wherein the processor is configured to select a database entry from the database using one or more features returned by the feature extraction step (see paragraph 0033, where a camera can obtain images of a surgical instrument, and relay signals based on the image to a processor; see paragraph 0041, where the processor can use the above signals to access information on the instrument from a database),
and to read one or more parameters of an electrosurgical therapy signal from the selected database entry (see paragraphs 0033 and 0041, where the database supplies information related to the instrument, such as control panel information for modifying the operational parameters of the instrument; paragraphs 0012 and 0040 specify that the instrument can be an electrosurgical instrument that receives RF frequency signals based on the operational parameters).
Shelton and Swayze are considered analogous art, as they are both directed to detection and control of electrosurgical instruments from images. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have integrated the teachings of Swayze into Shelton because doing so allows for seamless control of different types of surgical tools during surgery (see Swayze paragraph 0027).
Regarding claim 15, Shelton in view of Swayze discloses claim 15 as applied to claim 8 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS JOHN HELCO whose telephone number is (703)756-5539. The examiner can normally be reached on Monday-Friday from 9:00 AM to 5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella, can be reached at telephone number 571-272-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS JOHN HELCO/Examiner, Art Unit 2667
/MATTHEW C BELLA/Supervisory Patent Examiner, Art Unit 2667