DETAILED ACTION
Preliminary Amendment
Applicant’s submission of a preliminary amendment on 1/9/2023 has been received. In the amendment, claims 1-19 were canceled and claims 20-36 were added.
Information Disclosure Statement
Applicant’s submission of an Information Disclosure Statement on 1/9/2023 has been received and considered.
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 20-36 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 20-36 are replete with indefinite and awkward language. The Examiner has provided several examples of indefinite and awkward language below, but Applicant is advised to review the entirety of each claim to address this issue.
The following are examples that are either indefinite or otherwise awkwardly worded:
In claim 20, line 2, “the human or animal body” lacks antecedent basis.
In claim 20, line 3, “in particular an endonasal region” is unclear if Applicant intends to claim the more specific of “endonasal region” or the broader language of “at least one region of interest of the human body or animal body, which immediately precedes, “in particular”.
In claim 20, line 9, “said instrument movements” lacks antecedent basis. It is unclear if the “said instrument movements” is directed to the endoscopic visualization instrument the endoscopic surgical instrument, or both instruments.
In claim 20, line 10, “working surfaces” lacks antecedent basis because only a singular working surface was introduced earlier in claim 20.
In claim 20, lines 10-11, “a hardware element forming a model, called a thematic model” is indefinite. Is applicant claiming the broader term “model” or the narrower term “thematic model”. If the latter, all references to “model” should be replaced with “thematic model”.
In claim 20, lines 12-13, “said interior space having internal dimensions of one and the same order of magnitude as the region of interest” is indefinite because the claims do not define the dimensions of either the “region of interest” or the “interior space”.
In claim 20, line 15, “each thematic model” lacks antecedent basis because only a singular “thematic model” was introduced earlier in claim 20.
In claim 20, line 16, the term “and/or” is awkward because the scope following the “and/or” is not clear or could be made more clear by alternative language. While the term “and/or” is not per se indefinite, the Examiner requests clarifying the claim scope of each feature following an “and/or” recitation or replacing the term “and/or” with language that is clearer.
In claim 20, line 29, “and said comprises a process” is indefinite. It appears that Applicant should remove “said” from this phrase.
The above list provides some of the indefinite/awkward language issues with claim 20. Claims 21-36 inherit the above language issues through dependency or suffer their own indefinite/awkward language issues. Again, Applicant is requested to review all claims for similar issues.
35 USC § 112, 6th Paragraph Analysis
Claims 20, 24, 25, 28, 29, 31, 32, and 34 include "means of" recitations that do not presume to invoke 35 USC § 112, 6th paragraph because the claims do not meet the following 3-prong analysis:
(A) the claim limitations must use the phrase "means for" or "step for;"
(B) the "means for" or "step for" must be modified by functional language; and
(C) the phrase "means for" or "step for" must not be modified by sufficient structure, material, or acts for achieving the specified function (see MPEP 2181; see also In re Donaldson).
That is, none of the “means of” recitations (e.g., see claim 20, line 5 as one example) invoke 112 6th paragraph because they fail the 3-prong analysis, including being modified by functional language or otherwise having sufficient structure to perform the function.
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.
Claims 20-X are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2016/0314710 to Jarc.
With regard to claim 1, Jarc discloses a method for assisting the learning (e.g., see at least paragraph 25, “Various simulation features described herein can allow users to learn and practice, an can allow quantification of user performance and tracking user progress.”), by an operator, of endoscopic surgery applied to at least one region of interest of the human or animal body (e.g., see at least paragraph 47 that discusses the use of an endoscope imaging instrument), in particular an endonasal region (e.g., as best understood, see at least paragraph 64 that states that the simulation system can be used in various types of surgeries and is capable of simulating an endonasal region), during an exercise carried out by said operator, said exercise comprising a set of movements of instruments operated by hand (e.g., see at least paragraph 69, “the user to manually move the arms or other elements by hand; see also manual operation in paragraph 26, that is “non-teleported (e.g., manual)”; see also paragraph 134 for discussion of “manual instruments”), carried out by said operator, by means of at least one endoscopic visualization instrument (e.g., see at least paragraph 47 that discusses the use of an endoscope imaging instrument) equipped with at least one lens system returning a working image and by means of at least one endoscopic surgical instrument (e.g., see at least paragraphs 131-133 for discussion of surgical instruments) equipped with at least one working head capable of carrying out an interaction with a working surface (e.g., see at least paragraph 133 that discusses the use of “fully functional surgical instruments”), said instrument movements being carried out in a working space (e.g., see at least paragraph 153, “model 820 can include a hollow space underneath or within, which can be hold one or more physical surgical sites 824 at which physical exercises can take place manipulating exercise objects, such as flexible materials, threads, beads on wires, etc.”), delimited by working surfaces within an interior space of a hardware element forming a model called thematic model (e.g., see at least paragraph 153 that discusses “an example of an anatomical model 820…objects, such as flexible materials, threads, beads on wires, etc.”); said interior space having internal dimensions of one and the same order of magnitude as the region of interest (e.g., see at least paragraph 153, “model 820 can include a hollow space underneath or within, which can be hold one or more physical surgical sites 824); said method comprising the working image used by the operator is a camera video feedback (e.g., see paragraph 40 that discusses “video feed from an endoscope or other imaging device”) and shows the interior space of the hardware element forming said thematic model, each thematic model corresponding to one or more exercises (e.g., see at least paragraph 41 for discussion of displaying images on a display console 104 during user exercises), comprising a series of visualization and/or surgical moves which have to be carried out by the operator (e.g.., see at least paragraph 75 for discussion of completing surgical exercises); and said method is implemented by at least one electronic or computer device arranged to form a management unit (e.g., see at least paragraph 59 that discusses a computer system for simulating “different medical procedures”), equipped with a connection interface which is functionally connected to at least the visualization instrument and/or the surgical instrument, and to the thematic model (e.g., see at least paragraphs 38-40 discussion of connections 105 for a surgical console 104); comprises receiving and processing, by said management unit by means of said connection interface (e.g., see at least paragraphs 38-40 discussion of connections 105 for a surgical console 104), data called exercise data originating - the visualization instrument (e.g., see at least paragraph 47 that discusses the use of an endoscope imaging instrument), - the surgical instrument (e.g., see at least paragraphs 131-133 for discussion of surgical instruments), - the thematic model (e.g., model 820); - a sub-assembly of the thematic model, said sub-assembly comprising one or more mobile elements (e.g., see at least paragraph 153 that discusses “an example of an anatomical model 820…objects, such as flexible materials, threads, beads on wires, etc.”, wherein the flexible materials, threads, beads on wires equate to mobile elements in a model subassembly); and said comprises a process of evaluating the instrument movements during said exercise (e.g., see at least paragraph 34 that discusses tracking the positions of the physical surgical instruments), carried out by said management unit and comprising: - processing said exercise data in order to model all or some of the instrument movements; and - comparing said movements with goal data showing one or more determined criteria; and the evaluation process (e.g., see at least paragraphs 50, 66, 76, and 77 for discussion of evaluating and scoring simulation tasks) comprises at least a processing of interaction data, showing the occurrence of one or more events of interaction between at least two elements out of:- said at least one surgical instrument or a working head with which said surgical instrument is equipped (e.g., see at least paragraphs 131-133 for discussion of surgical instruments); - one or more mobile elements forming said sub-assemblies of the thematic model (e.g., see at least paragraph 153 that discusses “an example of an anatomical model 820…objects, such as flexible materials, threads, beads on wires, etc.”, wherein the flexible materials, threads, beads on wires equate to mobile elements in a model subassembly); and - one or more detection portions of the thematic model connected to the management unit; said method providing a hardware simulation where haptic feedbacks are real and accurate for the operator (e.g., see at least paragraph 84 for discussion of “haptic data for outputting haptic output”);
[claim 21] characterized in that the evaluation process comprises at least a processing of image data originating from the visualization instrument and showing one or more working images (e.g., see at least paragraph 40 for discussion of processing data from video feeds of surgical instruments), said processing comprising at least: - a graphic recognition process carrying out an identification and/or a dimensional measurement of one or more target patterns carried by the working surface (e.g., see at least paragraph 68 that discusses “the model…have specific pattern sequence or distance requirements”); and - an analysis of said working images so as to evaluate the position and/or the movements of the lens system with respect to the working space (e.g., see at least paragraphs 75 and 76 for discussion of feedback analysis including evaluation and scoring including a summary of placement positions);
[claim 22] characterized in that the evaluation process comprises at least a processing of movement data originating from the visualization instrument, and/or from the surgical instrument or its working head, which data show a position and/or a movement of one or more articulations within said instrument (e.g., see at least paragraph 100 that discusses “a score can be based on the time needed to perform one or more tasks during the procedure and/or positioning or movement of system components during one or more tasks”);
[claim 23] characterized in that the evaluation process comprises at least a processing of movement data originating from the surgical instrument, which data show a number of working movements carried out by the working head, alone or combined with data showing the completeness or the success of said working movements (e.g., see at least paragraphs 75 and 76 for discussion of feedback analysis including evaluation and scoring including a summary of placement positions);
[claim 24] characterized in that the evaluation process comprises at least a processing of the measurement of a duration for carrying out the exercise (e.g., see at least paragraph 100 that discusses “a score can be based on the time needed to perform one or more tasks during the procedure and/or positioning or movement of system components during one or more tasks”)(underline added for emphasis by the Examiner), which is calculated between a start point and an end point, which are each determined by a manual activation and/or by a detection of an event by means of data received from one or more elements out of:- at least one instrument or its working head (e.g., see at least paragraphs 131-133 for discussion of surgical instruments); - one or more mobile elements forming sub-assemblies of the thematic model; and - one or more detection portions of the thematic model in the case where it is connected to the management unit (e.g., see at least paragraph 153 that discusses “an example of an anatomical model 820…objects, such as flexible materials, threads, beads on wires, etc.”, wherein the flexible materials, threads, beads on wires equate to mobile elements in a model subassembly).
With regard to claim 25, Jarc also discloses a system for assisting the learning, by an operator of endoscopic surgery applied to at least one region of interest of the human or animal body as set forth above in detail for claim 20, which is similar scope. Jarc also discloses detection regions as further required by claim 25 (e.g., see at least paragraph 73 that discusses “detection positions of surgical instruments and/or objects at the physical surgical site”). Also, consistent with MPEP 2113, the scope of claim 25 is to the product, not the process of a product- by-process claim.
With regard to claim 26, Jarc discloses the features of claim 25 and further including: characterized in that the thematic model comprises on the one hand a support forming a manikin or a manikin portion capable of being positioned in a realistic position for a surgical operation of the type concerned (e.g., see at least paragraph 57 that discusses “a portion of the a human body can be simulated” which is equivalent to a manikin”); and comprises on the other hand a plurality of different structures, called thematic modules, arranged to each be able to be fixed selectively in one and the same location of said support (e.g., see at least paragraph 153, “model 820 can include a hollow space underneath or within, which can be hold one or more physical surgical sites 824)(underline added by the Examiner for emphasis); each of said thematic modules comprising an interior space arranged to form a working space once fixed on said support, the assembly formed by the support and said thematic module thus producing the thematic model (e.g., see Fig. 8 that shows model 820 including an interior space that can be modified for different exercises);
[claim 27] characterized in that the thematic model or module carries, on its working surface, a plurality of target patterns, of one or more determined shapes and/or colours, indicated in different portions of said working surface so as to be visible by the visualization instrument in different positions and/or at different angles (e.g., see at least paragraph 122 for discussion of different patterns or colors in a dry-lab model);
[claim 28] characterized in that the thematic model or module carries, on its working surface, in particular on at least two lateral surfaces, one or more hooks each capable of receiving a flexible and/or elastic ring having to be put in place by means of the surgical instrument in a form the working head of which carries forceps (e.g., see at least paragraph 28 for discussion of rings in a model), in particular with the management unit arranged to implement:- a method to evaluate a number of movements of the surgical instrument which are necessary for putting in place a determined number of rings on a determined combination of said hook(s), and/or - a method to evaluate the number of working movements of the forceps which are necessary for putting in place a determined number of rings on a determined combination of said hook(s), and/or - a method to evaluate the number of contacts which are occasioned between the surgical instrument and the working surface before putting in place a determined number of rings on a determined combination of said hook(s) (e.g., see at least paragraph 108 for discussion of scoring user movements in an exercise);
[claim 29] characterized in that the thematic model or module contains, in its working space, one or more sub-assemblies each formed by an element to be dissected which is fixed to the working surface (e.g., see at least paragraph 106 for discussion of “cuts of tissue” which is equivalent to dissection), and which are intended to be separated from each other along a bonding surface, by means of the surgical instrument in a form the working head of which carries dissection forceps, in particular with the management unit arranged to implement:- a method to evaluate a number of movements of the surgical instrument which are necessary for carrying out said separation, and/or - a method to evaluate the number of working movements of a forceps which are necessary for carrying out said separation (e.g., see at least paragraph 108 for discussion of scoring user movements in an exercise);
[claim 30] characterized in that at least one element to be dissected comprises at least:- a first element made of foam (e.g., see at least paragraphs 28 and 131 that discuss “foam” for simulation exercises) which is fixed by one face to the working surface and which has on another face a bond plane (e.g., see paragraph 131 that discusses foam pieces may be secured in an anatomical model on an operating table), positioned transverse to a direction of introduction of the instruments into the working space, and on the other hand one or more second distinct absorbent elements made of foam (e.g., see at least paragraphs 28 and 131 that discuss “foam” for simulation exercises) which are bonded onto said first element along its bond plane, which second elements are intended to be separated from said first element along said bond plane; and/or - one or more elements made of elastomer each simulating a polyp and which is fixed on the working surface; and/or - one or more flexible labels, in particular made of foam (e.g., see at least paragraphs 28 and 131 that discuss “foam” for simulation exercises), each of which is bonded onto the working surface according to a bonding having a determined adhesive strength, in particular at a rate of several labels which have calibrated adhesive strengths and are different from each other;
[claim 31] characterized in that the thematic model or module has an elongated element, called a metallic path, produced from an electrically conductive material, around which a mobile element, in particular a ring, can slide longitudinally between a starting position and an arrival position by means of the surgical instrument in a form the working head of which carries forceps (e.g., see at least paragraph 105 for discussing of moving a ring on a pathway); with the management unit arranged to implement a method to evaluate the number of contacts which are occasioned between the surgical instrument and the metallic path in order to move the mobile element from the starting position to the arrival position (e.g., see at least the last sentence of paragraph 105 that discusses measuring performance); in particular with the management unit moreover arranged to implement:- a method to evaluate a number of movements of the surgical instrument which are necessary for moving the mobile element from the starting position to the arrival position, and/or - a method to evaluate the number of working movements of the forceps which are necessary for moving the mobile element from the starting position to the arrival position (e.g., see at least paragraph 108 for discussion of scoring user movements in an exercise).
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 32 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Jarc in view of Operation board game published by Hasbro on March 27, 1965 as evidenced by Wikipedia article (Operation).
With regard to claim 32, Jarc discloses all of the recited features including sensors in anatomical modes, but fails to expressly disclose a model that has one or more conductive edges which surrounds an entrance opening of the working space in order to form a working corridor around the instrument(s); and contains a plurality of receptacles, between which the operator has to move one or more mobile elements, by means of the surgical instrument in a form the working head of which carries forceps; with the management unit arranged to implement a method to evaluate the number of contacts which are occasioned between the surgical and/or visualization instrument on the one hand and the conductive edges on the other hand in order to move said mobile elements from one receptacle to the other. Claim 35 is directed movement of mobile elements through narrow openings.
Reasonably pertinent to the problem faced, Operation teaches detecting when a surgical simulation instrument engages a conductive edge of an opening forming a receptacle (e.g., see section for Gameplay in Wikipedia article). Regarding claim 35, Operation also teaches moving mobile elements through narrow openings.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the current invention to modify Jarc with the conductive alerts as taught by Operation in order to use a known technique to improve similar devices (methods, or products) in the same way. In this case, alerting the user that movement of instruments is outside a desired range helps teach the user the correct instrument movement.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Jarc in view of Ms. Sara’s Preschool Blog dated March 25, 2013, available online at: https://mssaraspreschoolblog.blogspot.com/2013/03/eggs-dissecting-hard-boiled-raw-eggs.html (Ms. Sara).
With regard to claim 33, Jarc discloses all of the recited features, but fails to expressly disclose dissecting a hard-boiled egg.
Reasonably pertinent to the problem faced, Ms. Sara teaches her preschool students how to dissect a hard-boiled egg (e.g., see screenshot of the blog, “Dissecting hard boiled & raw eggs”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the current invention to modify Jarc with the hard-boiled eggs as taught by Ms. Sara in order to use a known technique to improve similar devices (methods, or products) in the same way. In this case, teaching users, including “kiddos”, how to dissect a hard-boiled egg teaches them “about each of the parts they were uncovering” plus “When they are done, they got to eat their egg”, which provides educational advantages and nourishment.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Jarc in view of Foreign Patent Document JP 2007536011A (JP ‘011).
With regard to claim 33, Jarc discloses all of the recited features, but fails to expressly disclose a wedging surgical exercise.
Reasonably pertinent to the problem faced, JP ‘011 teaches a wedging surgical procedure (e.g., see Fig. 1, that shows a wedge cavity; see also second paragraph of English translation that teaches a “wedge opening technique is faster to learn”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the current invention to modify Jarc with the wedge training as taught by JP ‘011 in order to use a known technique to improve similar devices (methods, or products) in the same way. In this case, teaching a wedge technique for surgery allows users to train on known surgical techniques to improve their future performance.
Allowable Subject Matter
Claim 34 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, as well as, overcoming indefinite and awkward language. Claim 34 recites a thematic model that includes a storage compartment held by an elastic means, wherein the system evaluates the user’s performance of extracting mobile elements from the storage compartments secured by elastic means. The prior arts show manipulating mobile elements (e.g., rings, etc.), but not in the manner claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, includes:
U.S. Patent Application Publication No. 2022/0114915 to Masuda discusses an endonasal simulation (e.g., see Fig. 1).
U.S. Patent Application Publication No. 2021/0074183 to Van Flute discusses a laparoscopic simulator with user feedback and interchangeable models (e.g., see at least Fig. 2).
U.S. Patent Application Publication No. 2020/0357176 to Crowther discusses a VR surgical training system (e.g., see at least Fig. 1).
U.S. Patent Application Publication No. 2019/0362651 to Barral discusses a system for simulation of soft bodies (e.g., see at least Fig. 2B).
U.S. Patent Application Publication No. 2018/0116724 to Gmeiner discusses a surgery simulator and method including manipulating mobile elements (e.g., see Figs. 11 and 12).
U.S. Patent Application Publication No. 2017/0316720 to Singh discusses an endonasal surgical simulator with a thematic module (e.g., see at least Fig. 1).
U.S. Patent Application Publication No. 2010/0167250 to Ryan discusses a surgical training simulator with a working tool and a scope in an encloses space (e.g., see at least Figs. 1 and 2).
U.S. Patent Application Publication No. 2005/0142525 to Cotin discusses a surgical training system for laparoscopic procedures (e.g., see at least Figs 1, 3A, 3B, and 3C).
U.S. Patent No. 6,659,776 to Aumann discusses a portable laparoscopic training (e.g., see at least Fig. 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES S MCCLELLAN whose telephone number is (571)272-7167. The examiner can normally be reached Monday-Friday (8:30AM-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, Kang Hu can be reached at 571-270-1344. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James S. McClellan/Primary Examiner, Art Unit 3715