Detailed 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.
Claims 1-22 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The term “optimally” in claim 1 is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and thus one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, since it is not possible to determine the metes and bounds of the feature “said module being optimally distributed over the cloud server and the controller device,” it renders claim 1 indefinite.
Regarding claim 7, the word "like" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 9, the abbreviation "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The remaining claims are rejected for incorporating this error from claim 1.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. If this application names joint inventors, Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 6, 7 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez et al (US 5,823,787) in view of Grubbs (US 2018/0338806 A1).
Regarding claim 1, Gonzalez discloses a system for Airway Management training for healthcare professionals (Abstract) comprising a manikin having a head (1), a trachea (14), an esophagus (20), a pair of lungs (18 – 19) and a stomach (22), wherein said manikin further comprises endotracheal implements (col. 7 line 59: endotracheal tube). Grubbs suggests—where Gonzalez does not disclose—wherein said manikin is operatively connected to a family of sensors at one end (¶ [0009]: first and second sensors) and to an electronic controller device at the other end (¶ [0009]: processor), said controller device is connected to a cloud server (¶¶ [0249] – [0257]) and a graphic user interface is connected to the system (¶ [0223]) and there is provided an Artificial Intelligence module for processing the data collected by the controller device and sent to the cloud server instantaneously (¶¶ [0363] – [0365]) and for deriving relevant and useful insights as well as for personalizing the feedback and generating an Augmented reality effect in the user's Graphic Interface (¶ [0187]), said module being optimally distributed over the cloud server and the controller device (¶¶ [0249] – [0257]). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the invention to combine the disclosures of Gonzalez and Grubbs in order to provide for remote learning.
Regarding claim 4, Grubbs suggests—where Gonzalez does not disclose—wherein one or more display devices are operatively connected to the Graphic User Interface which is applied by the user to log on to the cloud server and for visualizing the results of the training (¶ [0259]). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the invention to combine the disclosures of Gonzalez and Grubbs in order to provide for remote learning.
Regarding claim 6, Grubbs suggests—where Gonzalez does not disclose—wherein the Artificial Intelligence module is adapted to provide adaptive guidance and training assessment, specific to the situation, user and manikin, at any given point of time (¶ [0365]). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the invention to combine the disclosures of Gonzalez and Grubbs in order to provide for real-time surgical assistance.
Regarding claim 7, Grubbs suggests—where Gonzalez does not disclose—wherein the Artificial Intelligence module is adapted to ensure accurate calculation of the position of the endo-tracheal tube inside the manikin, based on triangulation of data from multiple, manikin-embedded sensors (¶ [0365]) and helps in identification of signature moments like entry into esophagus instead of trachea and personalization of learning recommendation for the user (¶ [0365]). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the invention to combine the disclosures of Gonzalez and Grubbs in order to provide for real-time surgical assistance.
Regarding claim 9, Grubbs suggests—where Gonzalez does not disclose—wherein the controller is essentially comprised of a central processor (e.g., Raspberry PI), Analog to Digital (ADC) converters, multiplexers, resistors and transistors (¶ [0223]). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the invention to combine the disclosures of Gonzalez and Grubbs in order to provide for real-time surgical assistance.
Regarding claim 10, Grubbs suggests—where Gonzalez does not disclose—wherein a deterministic module is hosted on the Internet cloud for processing the training-session data to determine the exact position of the magnetic tube-tip inside the manikin (¶¶ [0187] and [0223]). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the invention to combine the disclosures of Gonzalez and Grubbs in order to provide for real-time surgical assistance.
Regarding claim 11, Grubbs suggests—where Gonzalez does not disclose—wherein there is an augmented reality module that displays the happenings inside the manikin on an external monitor (¶ [0187]). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the invention to combine the disclosures of Gonzalez and Grubbs in order to provide for real-time surgical assistance.
Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez in view of Grubbs and Cooper et al (US 2012/0298101 A1).
Regarding claim 2, Gonzalez discloses wherein the endotracheal elements comprise a Laryngoscope (col. 11 line 46) and an Endo-Tracheal Tube (col. 7 line 59). Cooper suggests—where Gonzalez does not disclose—an Endo-Tracheal Tube fitted with a small magnet at its tip (Fig. 1). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the invention to combine the disclosures of Gonzalez, Grubbs and Cooper in order to make the tube easier to insert and manipulate.
Regarding claim 5, Cooper suggests—where Gonzalez does not disclose—wherein the endo-tracheal elements have an endo-tracheal tube tip is fitted with a small cylindrical and hollow (¶ [0040]) Neodymium (¶ [0077]) magnet, fixed on the inner wall of the endo-tracheal tube, close to the tip (Figs. 6-7). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the invention to combine the disclosures of Gonzalez, Grubbs and Cooper in order to make the tube easier to insert and manipulate.
Response to Arguments
Claims 3, 8 and 12-22 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.
Conclusion
The prior art considered pertinent to applicant's disclosure and not relied upon is made of record on the attached PTO-892 form.
Freeman et al (US 20240148464 A1) discloses augmented reality surgery feedback.
Wang et al (US 11810473 B2) discloses optical surface tracking for medical simulations.
Lutsenko et al (US 4850876 A) discloses an electronic surgical practice dummy.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVE ROWLAND whose telephone number is (469) 295-9129. The examiner can normally be reached on M-Th 10-8. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Dmitry Suhol can be reached at (571) 272-4430. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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Authorization may be perfected by submitting, on a separate paper, the following (or similar) disclaimer:
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Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with me concerning any subject matter of this application by electronic mail. I understand that a copy of these communications will be made of record in the application file.
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See MPEP 502.03 for more information.
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/STEVE ROWLAND/Primary Examiner, Art Unit 3715
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