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 .
This action is in response to the filing on 6/18/2024. Since the initial filing, no claims have been added, amended or cancelled. Thus, claims 1-9 are pending in the application.
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.
Claim 9 is rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 9 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 9 positively recites the patient in a manner which encompasses the patient.
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 1-9 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.
Claim 1 recites the limitation of identifying “presence of a tracheal carina, an endotracheal tube (ETT) and a tracheostomy tube” in line 6-7. It is unclear if the endotracheal tube (ETT) and the tracheostomy tube are intended to be alternatives. Based upon the further language of claim 1, language found in dependent claims, and the disclosure of the instant specification, Examiner is interpreting the endotracheal tube (ETT) and the tracheostomy tube as alternatives. Should this be the correct interpretation, Examiner suggests amending to “presence of a tracheal carina and an endotracheal tube (ETT) or a tracheostomy tube” to clarify.
Dependent claims inherit the rejection of their predecessors.
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.
Claim(s) 1 and 4-9 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tegzes (US 2024/0164845).
In regards to claim 1, Tegzes discloses as endotracheal tube position anomaly alerting device, for monitoring correctness of a position of an endotracheal tube (analysis apparatus 200), comprising: a monitoring module for collecting patients’ chest X-ray image data (imaging device may be x-ray, paragraph 56 and 72, data source 210, paragraph 93); an object detection module connected to the monitoring module to receive the chest X-ray image data from the monitoring module and use an artificial intelligence (AI) algorithm model (AI system 220, paragraph 93) to identify presence of a tracheal carina, an endotracheal tube (ETT) and a tracheostomy tube and mark positions thereof in the chest X-ray image data (paragraph 94 and 106); a position evaluation module connected to the object detection module to automatically measure a distance between an endotracheal tube tip and the tracheal carina upon detection of presence of the tracheal carina and the endotracheal tube by the object detection module and according to mark positions of a determination result of the artificial intelligence (AI) algorithm model (distance computer 1030, paragraph 102-103), generate an evaluation result of the endotracheal tube position appropriateness according to the distance thus measured (paragraph 122 and 125), and trigger an alert when the evaluation result indicates that the position of the endotracheal tube does not fall within a correct range (paragraph 126, Fig 5); and a display module connected to the position evaluation module to receive the determination result of the object detection module and the position evaluation module, send an alerting signal, and display an object marking result and the evaluation result of the endotracheal tube position appropriateness (paragraph 125-126, Fig 5).
In regards to claim 4, Tegzes discloses the device of claim 1 and Tegzes further discloses wherein the position evaluation module measures the distance between the endotracheal tube tip and the tracheal carina by selecting the leftmost coordinate pair and the rightmost coordinate pair on the lower edge of a marking bounding box of the identified endotracheal tube tip and the midpoint between two points calculated with a function, calculating a distance from each of the three points to the tracheal carina with Euclidean distance equation, selecting the shortest distance, and converting pixel values of the distance in the image into the actual distance (paragraph 103 and 123 and 127).
In regards to claim 5, Tegzes discloses the device of claim 1 and Tegzes further discloses wherein the position evaluation module triggers an alert (paragraph 126) when the endotracheal tube tip is lower than the tracheal carina or when the distance between the endotracheal tube tip and the tracheal carina is less than 3 cm or greater than 5 cm (paragraph 125, Fig 5).
In regards to claim 6, Tegzes discloses the device of claim 1 and Tegzes further discloses wherein a means of triggering the alert includes but is not limited to a picture, a flashing picture or sound (paragraph 75 line 12-19 and paragraph 125).
In regards to claim 7, Tegzes discloses the device of claim 5 and Tegzes further discloses wherein a means of triggering the alert includes but is not limited to a picture, a flashing picture or sound (paragraph 75 line 12-19 and paragraph 125).
In regards to claim 8, Tegzes discloses the device of claim 1 and Tegzes further discloses wherein the chest X-ray image data of the object detection module includes chest X-ray images indicative of the presence of the endotracheal tube, chest X-ray images indicative of the presence of the tracheostomy tube, and chest X-ray images indicative of the absence of the endotracheal tube or tracheostomy tube (paragraph 73-74 and 108).
In regards to claim 9, Tegzes discloses the device of claim 1 and Tegzes further discloses wherein the chest X-ray images indicative of the presence of the endotracheal tube mainly originate from the chest X-rays of patients who need to undergo endotracheal tube-based therapy, including cases where the endotracheal tube positions are appropriate and cases where the endotracheal tube positions are inappropriate, with the patients differing in endotracheal tube experience and thoracic anatomical structures (paragraph 73-74 and 108 and 126).
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.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegzes (US 2024/0164845) in view of Gustin (US 2022/0398814) and Kim (US 2023/0088974).
In regards to claim 2, Tegzes discloses the device of claim 1 and Tegzes further discloses wherein the object detection module, inputs a plurality of chest X-ray image data, treats the plurality of chest X-ray image data as a training dataset (paragraph 74 line 43-49) and a testing dataset for deep learning according to a predetermined ratio (paragraph 84), performs model training with the training dataset, performs testing with the testing dataset (paragraph 84).
Tegzes does not wherein the deep learning model is YOLOv5, performs verification to finish training the artificial intelligence (AI) algorithm model, and evaluates the performance of the artificial intelligence (AI) algorithm model according to a standard performance evaluation indicator.
However, Gustin teaches a medical imaging system using a deep learning model wherein the deep learning model is YOLOv5 (paragraph 76).
Further, Kim teaches wherein the system performs verification to finish training the artificial intelligence (AI) algorithm model (paragraph 146), and evaluates the performance of the artificial intelligence (AI) algorithm model according to a standard performance evaluation indicator (paragraph 149-150).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tegzes wherein the deep learning model is YOLOv5, performs verification to finish training the artificial intelligence (AI) algorithm model, and evaluates the performance of the artificial intelligence (AI) algorithm model according to a standard performance evaluation indicator as taught by Gustin and Kim as these are known models and methods for testing such models.
In regards to claim 3, Tegzes in view of Gustin and Kim teaches the device of claim 2 and the combination further teaches wherein the standard performance evaluation indicator includes but is not limited to precision, recall, mean average precision (mAP@50), and accuracy (Kim: paragraph 149).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arielle Wolff whose telephone number is (571)272-8727. The examiner can normally be reached Mon-Fri 8:00-4:00.
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/ARIELLE WOLFF/ Examiner, Art Unit 3785
/PAIGE KATHLEEN BUGG/ Primary Examiner, Art Unit 3785
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