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 .
Election/Restrictions
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Because the Applicant did not specify whether the election was made with or without traverse, Examiner will assume that the election was made without traverse, in the reply filed on January 5th, 2026.
Applicant’s election without traverse of Group I (Claims 1-14) in the reply filed on January 5th, 2026 is acknowledged.
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:
“diagnosis device” in Claims 1-5 and 11-13: Although the Applicant’s Specification recites this term, there is no clear structure recited for the “diagnosis device”
“image capturing device” in Claims 1-2: [0045] of the Applicant’s Specification recites wherein the “image capturing device” is in the form of a “camera”
“instrument” in Claim 1: [0012] of the Applicant’s Specification recites wherein the “application device comprises an instrument for application of a treatment medium on the tissue. For example, the instrument can be a plasma instrument, particularly an instrument for creation of an argon plasma jet”
“apparatus” in Claim 1: [0013] of the Applicant’s Specification recites wherein the “application device comprises in addition an apparatus for supply of the instrument. The apparatus is configured to provide the instrument with operating medium and energy. The operating medium can be the treatment medium itself or a medium from which the treatment medium is created under aid of energy. If the treatment medium is cold or warm argon plasma, the operating medium is argon, for example. Energy is then provided in form of high frequency voltage or high frequency current, for example”
“navigation device” in Claims 1, 3-5, and 12-13: Dependent claims 7-9 recite wherein the navigation device comprises a “display device”, “monitoring device”, or “recording device”
“monitoring device” in Claim 8: [0051] of the Applicant’s Specification recites a “treatment monitor”
“recording device” in Claim 9: [0023] of the Applicant’s Specification recites wherein the navigation device “comprises a recording device that is configured to record the treatment dosage resulting from the influence of the treatment medium on the tissue. Such a recording of the treatment dosage can be achieved, for example, in that the location and the influence duration of the treatment medium on the tissue is captured by means of a camera, for example, and the applied treatment dosage is determined depending on the location, if necessary under consideration of the intensity of the treatment medium, i.e. the plasma jet”
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.
Claims 1-14 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.
The claim limitations “navigation device” and “monitoring device” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Claim 1 recites “navigation device” in line 11. Although dependent claims 7, 8, and 9 recite wherein the navigation device comprises a “display device”, “monitoring device”, or “recording device”, respectively, it is unclear as to whether the “navigation device” of claim 1 requires specifically the “display device”, the “monitoring device”, the “recording device”, any one of those devices, or require all three of the devices. Clarification is requested.
Claim 8 recites a “monitoring device (21)” line 2. It is unclear as to whether this limitation is referring to the “treatment monitor 25” from the Applicant’s Specification, or a separate element. Furthermore, the numeral “21” is used to denote the “monitoring device” in Claim 8, but in the Applicant’s Specification, the numeral “21” is used to denote an “image capturing device” or “camera”. Clarification is requested.
Therefore, the claims are indefinite and rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 2 recites “in this manner” in lines 3-4. It is unclear as to what this limitation exactly entails. The phrase “in this manner” is usually used to describe a specific method in which an action is performed, but it is unclear as to exactly what technique this limitation is referring to in this case.
Claim 3 recites “in this manner” in line 4. Similar to Claim 2, it is unclear as to what this limitation exactly entails. The phrase “in this manner” is usually used to describe a specific method in which an action is performed, but it is unclear as to exactly what technique this limitation is referring to in this case.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al (U.S. Publication No. 2023/0071306).
Regarding Claim 1, Miller discloses a treatment device (10) for treatment of human or animal tissue (Systems and methods for delivering targeted therapy; Abstract) comprising:
a diagnosis device (15) (elongate device 202; [0046]) having an image capturing device (16) (imaging sensor 230; [0047]) for capturing at least one image (17) of the tissue (11) (Elongate device 202 may include imaging sensor 230, such tool based imaging devices for providing intraoperative images, for example endoscopic cameras (singular or plurality of cameras), endoluminal or intravascular ultrasound, optical coherence tomography (OCT) device, confocal microscopy and/or the like. Elongate device 202's position and/or orientation can be determined based on information from the imaging sensor 230 and/or from position sensor(s) 206 a, 206 b; [0047]), wherein the diagnosis device (15) is configured for identification of zones (27, 28, 29) having need for treatment (At process 320, an anatomic model or map of patient anatomy can be created. In one embodiment, the model is generated from data collected as elongate device 102 is navigated through an anatomical path towards the anatomical target. The data can be provided by one or more of position, localization, and imaging sensors, such as shape sensor 108, position sensor 106, and imaging sensor 230 coupled to elongate device 102; [0055]; At process 330, one or more specific anatomical target areas of interest are identified within the model generated in process 320. The areas may include anatomical structures within the body to be used as landmarks during navigation of the device; areas identified for treatment, such as lesions, tumors, or diseased tissue; sensitive structures or anatomy to be avoided during treatment, which may be located in close proximity to the treatment areas; and/or artificially identified locations, such as a previously placed real or synthetically generated markers within the tissue; [0058]),
an application device (18) (The medical instrument 226 may include an imaging device (endoscopic camera, ultrasound transducer, etc.), a diagnostic device, and/or a treatment device; [0053]) comprising:
an instrument (19) configured for application of a treatment medium (23) on the tissue (11) to be treated (a treatment procedure for hyperplastic tissue, hypertrophic tissue, gastrointestinal (enteric) nerves, cells of cajal in the stomach or other abnormal tissue can be performed in process 360…the medical instrument 226 may be an ablation probe and may be controlled at least in part with computer assistance so an ablation pattern may be automatically or autonomously created according to the treatment plan; [0081-0085]),
an apparatus (20) connected with the instrument (19) configured for supplying the instrument (19) with an operating medium and energy (A third class of treatments are more targeted ablation therapies, including RF, microwave, ultrasound, direct heat, laser ablation, ultra-sonic waves, plasma energy, electroporation, cryoablation, etc. delivered by an ablative medical instrument 708 as shown in FIG. 7C may be used to target specific areas of hyperplastic or hypertrophic tissue; [0082]), and
a navigation device (22) configured to determine a location and a desired influence intensity of the treatment medium (23) on the tissue (11) (A master assembly 806 allows an operator O (e.g., a clinical user as illustrated in FIG. 8 ) to control manipulator assembly 802. A display system 810 (e.g., the display system 110) allows the operator to view the treatment site by displaying a live image and/or a representation of the treatment site and medical instrument 804 generated by subsystems of sensor system 808, as well as displaying images and instructions for navigational guidance. Sensor system 808 can include one or more subsystems for receiving information about the instruments of manipulator assembly 802. The sensor system 808 may include sensors 106, 108, for example. Such subsystems may include a position/location sensor system (e.g., an EM sensor system); a shape sensor system for determining the position, orientation, speed, velocity, pose, and/or shape of a distal end and/or of one or more segments along a flexible body that may make up medical instrument 804; and/or a visualization system for capturing images from the distal end of medical instrument 804; [0080]; Elongate device 1002 is similar in construction and function as elongate devices 102 and 202 described above, except where described herein. Elongate device 1002 includes a flexible body 1016 having a distal end portion 1018, main lumen 1004, one or more instruments 1026 (e.g., catheters 1022) in the main lumen, one or more navigation sensors 1006, and one or more imaging sensors 1030. The elongate device 1002 may be implemented as part of the computer-assisted teleoperated medical system 800, described above, and controlled using control system 122/812. The various imaging sensors 1030, navigation sensors 1006, and imaging analyses described herein may be used in isolation or in combination to assist with manually or automatically navigating the elongate device 1002 through the pylorus and into the pyloric channel using the computer-assisted teleoperated medical system 800, as feedback to align and navigate the elongate device 1002 with the pyloric sphincter and pyloric channel; [0092]).
Regarding Claim 2, Miller discloses wherein the diagnosis device (15) is configured to identify zones (27, 28, 29) of different lesions in the at least one image (17) captured by the image capturing device (16) and to generate a diagnosis map (26) in this manner (At process 330, one or more specific anatomical target areas of interest are identified within the model generated in process 320…at process 340, the target area(s) of interest identified in process 330 are then displayed or rendered on the model of the anatomy generated from process 320 so as to create an updated model…at process 350, the updated model is used to plan a medical procedure that includes determining a navigational path to an anatomic or ablation target and/or creating a treatment plan; [0058-0062]).
Regarding Claim 3, Miller discloses wherein the navigation device (22) and/or the diagnosis device (15) is configured to assign an influence intensity to each point of the tissue (11) captured by the at least one image (17) and to create a treatment plan map (30) in this manner (Treatment plans optionally include determining treatment parameters, such as treatment location, size of treatment area, treatment depth, number of treatments, and spacing of treatments…the treatment plan and/or updated treatment plan can be automatically created based on the model or updated model, and empirical data of ablation size, depth, and power requirements are correlated with tissue type and type of anatomical target (e.g., tumor or other hyperplastic tissue); [0063-0067]).
Regarding Claim 4, Miller discloses wherein the navigation device (22) and/or the diagnosis device (15) is configured to use a transformation rule for creation of the treatment plan map (30) from the diagnosis map (26) (At process 320, an anatomic model or map of patient anatomy can be created. In one embodiment, the model is generated from data collected as elongate device 102 is navigated through an anatomical path towards the anatomical target. The data can be provided by one or more of position, localization, and imaging sensors, such as shape sensor 108, position sensor 106, and imaging sensor 230 coupled to elongate device 102…the model may then be built including diameters of the of the anatomy by using either standard anatomical human data, using elongate device 102 and localization sensing to touch anatomical walls to determine area or volume, and/or data from imaging sensor 230 where diameter can be determined using image-based methods; [0055]; At process 330, one or more specific anatomical target areas of interest are identified within the model generated in process 320. The areas may include anatomical structures within the body to be used as landmarks during navigation of the device; areas identified for treatment, such as lesions, tumors, or diseased tissue; sensitive structures or anatomy to be avoided during treatment, which may be located in close proximity to the treatment areas; and/or artificially identified locations, such as a previously placed real or synthetically generated markers within the tissue…at process 340, the target area(s) of interest identified in process 330 are then displayed or rendered on the model of the anatomy generated from process 320 so as to create an updated model…At process 350, the updated model is used to plan a medical procedure that includes determining a navigational path to an anatomic or ablation target and/or creating a treatment plan; [0058-0062]; Treatment plans optionally include determining treatment parameters, such as treatment location, size of treatment area, treatment depth, number of treatments, and spacing of treatments…the treatment plan and/or updated treatment plan can be automatically created based on the model or updated model, and empirical data of ablation size, depth, and power requirements are correlated with tissue type and type of anatomical target (e.g., tumor or other hyperplastic tissue); [0063-0067]).
Regarding Claim 5, Miller discloses wherein the navigation device (22) and/or the diagnosis device (15) is configured to detect temporal variations of colorization in the at least one image (17) created during a staining test and to assign a necessary influence intensity to each point of the tissue (11) captured by the images (17) (In some embodiments, the model is a 3D model, and so the location and depth of the tissue target can be accurately displayed on the model and highlighted with a specific color, shade, hue, and/or transparency to visibly distinguish target and healthy tissue; [0061]; The navigational guidance can include the treatment plan, which optionally includes treatment parameters determined during process 350, such as indicators showing locations, sizes, depth, number, pattern, and number of treatment zones within the model. In some embodiments, the indicators can be altered in color, transparency, hue, size, etc., as ablative energy is delivered to tissue, thus providing the user with visual feedback of energy delivery. In some embodiments, the change in appearance of the indicators can be based on time of energy delivery and/or power of energy delivery. In other embodiments, the change in appearance of the indicators can be based on an expected effectiveness of ablation based on duration of energy delivery, power, depth and tissue type…the model can visually update an appearance of diseased tissue as it becomes ablated by changing color, shade, transparency, or hue relative to healthy or non-ablated tissue; [0070]; Imaging sensors (such as imaging sensors 1030 above) may be used to track and/or visualize indicators of ablation for the treated anatomy (e.g., tissue color changes, biochemical markers from cells that have been undergone treatment, or other products or byproducts of the ablation). In some embodiments, to track and visualize areas that have been treated, ablation may be applied by the methods described above, and the ablated region may be lightly marked or scored (e.g., by the same ablation treatment device) to indicate ablation has occurred. In some embodiments, tracking and/or visualizing may include marking the ablative locations on the tissue itself or marking a visual display based on the ablative locations that have been treated. The imaging sensors 1030 described above may be used to track and visualize the area of anatomy treated, the applied treatment amount, and/or optionally to characterize treatment effectiveness; [0173]).
Regarding Claim 6, Miller discloses wherein the treatment medium (23) is a non-thermal plasma (A third class of treatments are more targeted ablation therapies, including RF, microwave, ultrasound, direct heat, laser ablation, ultra-sonic waves, plasma energy, electroporation, cryoablation, etc. delivered by an ablative medical instrument 708 as shown in FIG. 7C may be used to target specific areas of hyperplastic or hypertrophic tissue; [0082]; Additional ablation mechanisms that may be used include plasma (both cold and hot) and sonic beam ultrasound (focal ultrasound therapy in combination with an external transducer). A plurality of plasma treatments may be used, including J plasma combining cold helium gas with radiofrequency energy, non-thermal (cold) plasma (partially ionized gas or gases comprising ions, electrons, ultraviolet photons and reactive neutrals such as radicals, excited, and ground-state molecules), argon plasma coagulation, and radiofrequency pulsed plasma (spray along the inside, then apply monopolar energy). The plasma may be delivered as a point or as a pinpoint, and automated delivery of plasma may be applied by advancing the elongate device 1002 while applying treatment for sub-millimeter depth targeted therapy; [0153]).
Regarding Claim 7, Miller discloses wherein the navigation device (22) comprises a display device (22b) that is configured to optically visibly represent the treatment plan map (30) in relation to the tissue (11) to be treated (display system 110; [0042]; The camera is used for capturing image data (including video image data) that are then processed by an imaging system, such as visualization system 131, for display and/or provided to tracking system, such as tracking system 130. The processed images are output to a clinical operator or are used by the system's control system to support tracking of distal end 218 and/or a portion of flexible body 216 along the length of flexible body; [0049]; At process 340, the target area(s) of interest identified in process 330 are then displayed or rendered on the model of the anatomy generated from process 320 so as to create an updated model. In some embodiments, if ultrasound is used to identify depth of target tissue, the target tissue can be displayed at a measured location within the model and at a detected depth based on ultrasound data; [0061]).
Regarding Claim 8, Miller discloses wherein the navigation device (22) comprises a monitoring device (21) configured for visual inspection of the tissue to be treated by a user and a display device (22b) configured to superimpose the treatment plan map (30) with the tissue (11) in an optically visible manner for the user (Optionally, at a process 355, one or more indicators of the target tissue, the treatment locations, the power settings, the ablation pattern, the landmarks, and/or the structures to treat or avoid are displayed on, included within, or overlaid on, the updated model generated in process 340 to create an updated planning model. The planning anatomic model and treatment plan can be displayed as instructions on a display, as indicators overlaid on the anatomic model generated during process 340, and/or as updates to the anatomic model. For example, using display system 110 shown in FIG. 1 , visual instructions can be provided indicating location of target tissue, power levels for ablation, duration of ablation, warning of proximity to sensitive anatomy, etc. Instructions can be audible, visible, or haptically provided. Indicators can be overlaid on the anatomic model to show location and depth of diseased tissue or to indicate location and depth of ablation lesions (lesions created within tissue after applying ablative energy). The instructions and/or indicators can be highlighted within the current updated model by being displayed in a different color, transparency, hue, size, etc.; [0068]).
Regarding Claim 9, Miller discloses wherein the navigation device (22) comprises a recording device (22a) by which a treatment dosage and/or an influence location resulting from the influence of the treatment medium (23) on the tissue (11) can be detected (The treatment plan can include not only locations, surface area, sizes, and depths of hyperplastic and hypertrophic tissue but also margins around hyperplastic tissue at a lesser depth than where the hyperplastic and/or hypertrophic tissue was visibly initially identified during the identification stage. During the delivery of ablative energy, hyperplastic, hypertrophic, abnormal or other target tissue and various anatomical structures can be identified visually in endoscopic camera images as well as in, e.g., ultrasound or OCT images. Tissue may be identified as ablated, partially ablated, or non-ablated tissue by measuring impedance of the tissue and monitoring a change in impedance or comparing impedance measurements against pre-determined impedance thresholds; [0083]).
Regarding Claim 10, Miller discloses wherein the display device (22b) is configured to represent a treatment dosage in an influence map (31) (the model may be updated with locations of ablated, partially ablated or non-ablated target tissue. Thus after an initial treatment performed in process 360, the procedure can return to process 340 in which the location, size, and depth of ablated, partially ablated or non-ablated tissue is displayed on the current anatomical model to create an updated model, which can be used to create an updated treatment plan requiring additional ablations; [0073]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Maclellan et al (U.S. Publication No. 2022/0051409).
Regarding Claim 11, Miller discloses wherein the diagnosis device (15) is connected with a data storage (24) in order to store the diagnosis map (26) (Control system 812 includes at least one memory and at least one computer processor (not shown) for effecting control between medical instrument 804, master assembly 806, sensor system 808, and display system 810. Control system 812 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement some or all of the methods described in accordance with aspects disclosed herein, including instructions for providing information to display system 810; [0086]; a multistage process is provided for treatment, involving an initial mapping step, a treatment step, and a post-treatment assessment. During the initial mapping step, pre-operative and intra-operative (real time) characterization of the duodenum and/or jejunum is provided to characterize and identify areas to treat, particularly areas of the mucosal layer containing a relatively higher density or amount of hypertrophic mucosa and/or enter-endocrine hyperplasia and/or nerve cells. During the treatment step, the identified hypertrophic and hyperplastic areas are treated as described further herein. During the post-treatment assessment step, which may optionally be performed in real-time during a procedure, immediately after a procedure, or days or weeks after a procedure, an assessment is performed to determine treatment effectiveness; [0129]; The individual locations are stored along with an anatomical model as described above. The clinical user may use the locations along with generated visible tags associated with the locations for navigation. Likewise, the computer-assisted system may again identify the locations by using machine vision as it navigates or assists the user to navigate. In some embodiments, a neural network is used to identify hyperplastic abnormal mucosal cells within the proximal intestine based on supervised learning of historic data; [0137-0138]).
Although Miller discloses storing data for the users, Miller fails to specifically teach storing data in a patient-specific manner.
In a similar technical field, Maclellan systems and methods for using artificial intelligence for skin condition diagnosis and treatment options (Abstract), comprising storing data in a patient-specific manner (the user records 310 can include user profile information. For example, the application 320 executing on the client device can register a user profile that can include any of the information associated with the user as described herein. This information can include, for example, any of the skin images 220, the skin color classification 305, or any other information as described herein that can be provided by the application 320 or the user. The user profile information may include information such as the email address of the user, the name of the user, or any other identifying information about the user…the application can allow the user to create a user profile that includes identifying information. The user profile can be stored, for example, in the user records 310 of the data storage 315; [0113-0118]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the patient-specific user profile teachings of Maclellan into the invention of Miller in order to keep identifying information for each user profile and provide personalized treatment plans for each individual (Maclellan [0113-0118]).
Regarding Claim 12, Miller discloses wherein the diagnosis device (15) and/or the navigation device (22) is configured to create an influence map (31) (the model may be updated with locations of ablated, partially ablated or non-ablated target tissue. Thus after an initial treatment performed in process 360, the procedure can return to process 340 in which the location, size, and depth of ablated, partially ablated or non-ablated tissue is displayed on the current anatomical model to create an updated model, which can be used to create an updated treatment plan requiring additional ablations; [0073]) and is connected with the data storage (24) in order to store the influence map (31) (Control system 812 includes at least one memory and at least one computer processor (not shown) for effecting control between medical instrument 804, master assembly 806, sensor system 808, and display system 810. Control system 812 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement some or all of the methods described in accordance with aspects disclosed herein, including instructions for providing information to display system 810; [0086]; a multistage process is provided for treatment, involving an initial mapping step, a treatment step, and a post-treatment assessment. During the initial mapping step, pre-operative and intra-operative (real time) characterization of the duodenum and/or jejunum is provided to characterize and identify areas to treat, particularly areas of the mucosal layer containing a relatively higher density or amount of hypertrophic mucosa and/or enter-endocrine hyperplasia and/or nerve cells. During the treatment step, the identified hypertrophic and hyperplastic areas are treated as described further herein. During the post-treatment assessment step, which may optionally be performed in real-time during a procedure, immediately after a procedure, or days or weeks after a procedure, an assessment is performed to determine treatment effectiveness; [0129]; The individual locations are stored along with an anatomical model as described above. The clinical user may use the locations along with generated visible tags associated with the locations for navigation. Likewise, the computer-assisted system may again identify the locations by using machine vision as it navigates or assists the user to navigate. In some embodiments, a neural network is used to identify hyperplastic abnormal mucosal cells within the proximal intestine based on supervised learning of historic data; [0137-0138]).
Although Miller discloses storing data for the users, Miller fails to specifically teach storing data in a patient-specific manner.
In a similar technical field, Maclellan systems and methods for using artificial intelligence for skin condition diagnosis and treatment options (Abstract), comprising storing data in a patient-specific manner (the user records 310 can include user profile information. For example, the application 320 executing on the client device can register a user profile that can include any of the information associated with the user as described herein. This information can include, for example, any of the skin images 220, the skin color classification 305, or any other information as described herein that can be provided by the application 320 or the user. The user profile information may include information such as the email address of the user, the name of the user, or any other identifying information about the user…the application can allow the user to create a user profile that includes identifying information. The user profile can be stored, for example, in the user records 310 of the data storage 315; [0113-0118]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the patient-specific user profile teachings of Maclellan into the invention of Miller in order to keep identifying information for each user profile and provide personalized treatment plans for each individual (Maclellan [0113-0118]).
Regarding Claim 13, Miller discloses wherein the diagnosis device (15) and/or the navigation device (22) is configured to create an influence map (31) (the model may be updated with locations of ablated, partially ablated or non-ablated target tissue. Thus after an initial treatment performed in process 360, the procedure can return to process 340 in which the location, size, and depth of ablated, partially ablated or non-ablated tissue is displayed on the current anatomical model to create an updated model, which can be used to create an updated treatment plan requiring additional ablations; [0073]) and is connected with the data storage (24) in order to store the influence map (31) in a treating-person-specific manner (Control system 812 includes at least one memory and at least one computer processor (not shown) for effecting control between medical instrument 804, master assembly 806, sensor system 808, and display system 810. Control system 812 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement some or all of the methods described in accordance with aspects disclosed herein, including instructions for providing information to display system 810; [0086]; a multistage process is provided for treatment, involving an initial mapping step, a treatment step, and a post-treatment assessment. During the initial mapping step, pre-operative and intra-operative (real time) characterization of the duodenum and/or jejunum is provided to characterize and identify areas to treat, particularly areas of the mucosal layer containing a relatively higher density or amount of hypertrophic mucosa and/or enter-endocrine hyperplasia and/or nerve cells. During the treatment step, the identified hypertrophic and hyperplastic areas are treated as described further herein. During the post-treatment assessment step, which may optionally be performed in real-time during a procedure, immediately after a procedure, or days or weeks after a procedure, an assessment is performed to determine treatment effectiveness; [0129]; The individual locations are stored along with an anatomical model as described above. The clinical user may use the locations along with generated visible tags associated with the locations for navigation. Likewise, the computer-assisted system may again identify the locations by using machine vision as it navigates or assists the user to navigate. In some embodiments, a neural network is used to identify hyperplastic abnormal mucosal cells within the proximal intestine based on supervised learning of historic data; [0137-0138]). .
Although Miller discloses storing data for the users, Miller fails to specifically teach storing data in a treating-person-specific manner.
In a similar technical field, Maclellan systems and methods for using artificial intelligence for skin condition diagnosis and treatment options (Abstract), comprising storing data in a treating-person-specific manner (the user records 310 can include user profile information. For example, the application 320 executing on the client device can register a user profile that can include any of the information associated with the user as described herein. This information can include, for example, any of the skin images 220, the skin color classification 305, or any other information as described herein that can be provided by the application 320 or the user. The user profile information may include information such as the email address of the user, the name of the user, or any other identifying information about the user…the application can allow the user to create a user profile that includes identifying information. The user profile can be stored, for example, in the user records 310 of the data storage 315; [0113-0118]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the treating-person-specific user profile teachings of Maclellan into the invention of Miller in order to keep identifying information for each user profile and provide personalized treatment plans for each individual (Maclellan [0113-0118]).
Regarding Claim 14, Miller discloses wherein the data storage (24) is connected with a treatment monitor (25) that is configured to determine a treatment success based on a treatment plan map (30) determined at a first examination date, the influence map (31) and a treatment plan map (30) determined at a second examination date (The processes shown in the flowchart of medical procedure 300 may include additional processes or be performed in any order needed. For example, in some embodiments, target areas of interest may be identified in process 330 before the model of anatomy is created in process 320. In some embodiments, in process 320 an initial model is made from a generic model of human anatomy or from data such as a CT scan, then the target areas of interest in process 330 are identified during the real time procedure as the anatomy is explored, and then the initial model is updated in a separate process. In some embodiments, the model in process 320 is made while identifying target areas of interest in process 330. Additionally, in some embodiments, additional processes are performed. In some embodiments, the medical procedure performed is used to update the model. For example, the model may be updated with locations of ablated, partially ablated or non-ablated target tissue. Thus after an initial treatment performed in process 360, the procedure can return to process 340 in which the location, size, and depth of ablated, partially ablated or non-ablated tissue is displayed on the current anatomical model to create an updated model, which can be used to create an updated treatment plan requiring additional ablations; [0073]; a multistage process is provided for treatment, involving an initial mapping step, a treatment step, and a post-treatment assessment. During the initial mapping step, pre-operative and intra-operative (real time) characterization of the duodenum and/or jejunum is provided to characterize and identify areas to treat, particularly areas of the mucosal layer containing a relatively higher density or amount of hypertrophic mucosa and/or enter-endocrine hyperplasia and/or nerve cells. During the treatment step, the identified hypertrophic and hyperplastic areas are treated as described further herein. During the post-treatment assessment step, which may optionally be performed in real-time during a procedure, immediately after a procedure, or days or weeks after a procedure, an assessment is performed to determine treatment effectiveness; [0129]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J JHIN whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-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, Alexander Valvis can be reached on 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHANEL J JHIN/Examiner, Art Unit 3791