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 .
Information Disclosure Statement
As required by M.P.E.P. 609, the applicant’s submissions of the Information Disclosure Statement dated 3/13/2024 is acknowledged by the examiner and the cited references have been considered in the examination of the claims now pending.
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 1-30 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.
As to claim 1, 2, 6, 9, 19, 27, and 30, the claims recite “to associate” or “associate the operating data” which is a subjective term (MPEP 2173.05(b). Specifically, what constitutes “associated” is entirely subjective to a practitioner of the invention and/or the subject themselves. Connected or linked to what? The metes and bounds are unclear since those of ordinary skill in the art would fail to understand what qualifies as an association or connection, and thus infringement becomes unclear (MPEP 2173.05; 2173).
Claims 2-29 inherit their indefiniteness from independent claim 1 respectively.
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.
Claim(s) 1-14, 18-28, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parel (WO 2020180729 A1).
Regarding claim 1, Parel discloses an ophthalmic microscope assembly (Fig 3, [0049], ophthalmic imaging 100) comprising; a processing unit (60), an ophthalmic microscope with a camera (51), and a voice recorder ([0077], microphone), wherein the processing unit (60) is adapted to associate, in a report, voice data ([0098], convert the voice commands) from the voice recorder and image data ([0080], image data) from the microscope ([0057]-[0058], [0111], data transmitted over network 30 in 100 comprises information from ophthalmic device 10 and information from control device 20. Data from the ophthalmic device 10 includes at least image data of at least one of patient’s eyes).
Regarding claim 2, Parel discloses wherein the microscope (100) is adapted to send operating data ([0058], positional information regarding the ophthalmic device) indicative of one or more operating parameters of the microscope (100) to the processing unit (60) and the processing unit is adapted to: - associate the operating data ([0058], positional information regarding the ophthalmic device) with at least one of the voice data ([0098], convert the voice commands) and the image data ([0058], three-dimensional stereoscopic image of the patient’s eye) and/or - to associate, in the report, voice data from the voice recorder and image data ([0080], image data) from the microscope as a function of the operating data.
Recording claim 3, Parel discloses wherein the microscope (100) comprises, a patient's headrest (77), a microscope housing including microscope optics and the camera (Fig 3, [0088], device 10 contains a housing), a translational stage ([0094], stage of ophthalmic device 10) between the headrest and the microscope housing (Fig 3), wherein the stage is adapted to displace the microscope housing in respect to the headrest along - a horizontal direction Z defining a distance between the headrest and the microscope housing ([0127], mounting stage is structured for secure rotation, tipping, tilting, and other movements, and may comprise a tri-axis goniometric cradle and rotation and tip-tilt stages), and - a horizontal direction X perpendicular to direction Z ([0127], mounting stage is structured for secure rotation, tipping, tilting, and other movements, and may comprise a tri-axis goniometric cradle and rotation and tip-tilt stages), and a pivotal connection mounted to the translational stage, wherein the pivotal connection is adapted to rotate the microscope housing in respect to the translational stage about a vertical pivot axis, wherein the operating data is indicative of at least one of; - an X-offset along the horizontal direction X ([0127], mounting stage is structured for secure rotation, tipping, tilting, and other movements, and may comprise a tri-axis goniometric cradle and rotation and tip-tilt stages), or - a pivot angle (a)-about the pivot axis.
Regarding claim 4, Parel discloses wherein the microscope comprises an illumination source adapted to project light onto a patient's eye ([0102], eye examination), wherein the operating data is indicative of at least one illumination parameter of the illumination source ([0109]-[0110], identifying or anticipating a progression of views or movements, suggesting adjustments and/or minimizing extraneous movements between positions).
Regarding claim 5, Parel discloses wherein the illumination parameter is at least one of: a brightness of the illumination source, a width of an field illuminated by the illumination source on a patient's eye ([0102], slit assembly 80 of the present invention comprises a slit width adjustment member 84 structured to adjust a lateral dimension (width) of the slit of the slit assembly 80), a spectral composition of light generated by the illumination source, or a pivotal angle of the light source.
Regarding claim 6, Parel discloses wherein the processing unit (60) is adapted to associate, in the report, voice data from the voice recorder and image data ([0080], image data) from the microscope as a function of the operating data (Fig 4, Fig 7, [0096], external data capturing member 55 can also comprise audio capabilities to capture audio data from the patient, such as verbal responses).
Regarding claim 7, Parel discloses wherein the processing unit (60) comprises a speech recognition unit adapted to recognize keywords ([0098], convert voice commands of practitioner) and/or key phrases in the voice data.
Regarding claim 8, Parel discloses wherein said processing unit (60) comprises a categorizer ([0071], image capturing members 51 are high-definition camera) adapted to attribute the voice data and/or the image data ([0080], image data) of a current session ([0064], eye examination and diagnosis of certain eye conditions) and/or the current session itself to a subset of a plurality of predefined categories ([0064], ophthalmic device 10 is structured to obtain and transmit at least two images of at least one eye of a patient for the purpose of generating a stereoscopic image for the practitioner to view).
Regarding claim 9, Parel discloses wherein the microscope (100) is adapted to send operating data ([0058], positional information regarding the ophthalmic device) indicative of one or more operating parameters of the microscope (100) to the processing unit (60), and the processing unit (60) is adapted to at least one of associate the operating data with at least one of the voice data ([0098], convert the voice commands) and the image data ([0080], image data) and/or - to associate, in the report, voice data ([0098], voice commands) from the voice recorder and image data ([0058], three-dimensional stereoscopic image of the patient’s eye) from the microscope (100) as a function of the operating data ([0058], positional information regarding the ophthalmic device), and wherein the categorizer ([0071], image capturing members 51 are high-definition camera) is adapted to select the subset of categories as a function of the operating data ([0057]-[0058], [0111], data transmitted over network 30 in 100 comprises information from ophthalmic device 10 and information from control device 20. Data from the ophthalmic device 10 includes at least image data of at least one of patient’s eyes).
Regarding claim 10, Parel discloses wherein the microscope (100) comprises: a patient's headrest (77), a microscope housing including microscope optics and the camera (Fig 3, [0088], device 10 contains a housing), an translational stage ([0094], stage of ophthalmic device 10) between the headrest and the microscope housing (Fig 3), wherein the stage is adapted to displace the microscope housing in respect to the headrest along - a horizontal direction Z defining a distance between the headrest and the microscope housing ([0127], mounting stage is structured for secure rotation, tipping, tilting, and other movements, and may comprise a tri-axis goniometric cradle and rotation and tip-tilt stages), and- a horizontal direction X perpendicular to direction Z ([0127], mounting stage is structured for secure rotation, tipping, tilting, and other movements, and may comprise a tri-axis goniometric cradle and rotation and tip-tilt stages), and a pivotal connection mounted to the translational stage, wherein the pivotal connection is adapted to rotate the microscope housing in respect to the translational stage about a vertical pivot axis, wherein the operating data is indicative of at least one of:- an X-offset along the horizontal direction X ([0127], mounting stage is structured for secure rotation, tipping, tilting, and other movements, and may comprise a tri-axis goniometric cradle and rotation and tip-tilt stages) or - a pivot angle about the pivot axis, and wherein the categories are at least indicative of which eye is being measured ([0064], obtain and transmit at least two images of at least one eye of a patient), and the categorizer ([0071], image capturing members 51 are high-definition camera) is adapted to determine, as a function of the X-offset, if a left eye or a right eye is being measured ([0064], obtain and transmit at least two images of at least one eye of a patient).
Regarding claim 11, Parel discloses wherein the processing unit (60) comprises a speech recognition unit adapted to recognize at least one of keywords and key phrases in the voice data ([0098], convert voice commands of practitioner), and wherein the categorizer ([0071], image capturing members 51 are high-definition camera) is adapted to select the subset of categories as a function of the recognized keywords and/or key phrases ([0099], audio member 78 is configured to relay this verbal information to the patient so they may respond according to the practitioner’s instructions).
Regarding claim 12, Parel discloses wherein the categorizer ([0071], image capturing members 51 are high-definition camera) comprises an image classifier attributing images from the image data ([0080], image data) to one of several image types ([0071], identify plasma or hemorrhages and other moieties; discern damaged structures in the depth of an eye’s transparent tissue), and wherein the categorizer is adapted to select the subset of categories as a function of the attributed image types ([0071], identify plasma or hemorrhages and other moieties; discern damaged structures in the depth of an eye’s transparent tissue).
Regarding claim 13, Parel discloses wherein at least some of the categories are guided categories ([0078], database 314 of preset positioning values that operate sequentially to position the ophthalmic device 10), the processing unit (60) comprises a list storing, for each guided category, a list of required measurements ([0078], sequence of operations may be divided into one or a plurality of separate sequences), and the microscope assembly (100) comprises a guide adapted to test if the current session is categorized as a guided category and, if yes - to display guidance on a display ([0078], a sequence is initiated automatically, upon initiation of the patient, or upon initiation of the practitioner) and/or - to automatically execute at least part of the required measurements.
Regarding claim 14, Parel discloses wherein the stored list comprises for at least some of the guided categories ([0077]-[0078], database 314 of preset positioning values), a list of required images ([0077], patients electronic record), if the current session is categorized as a guided category by the guide, the guide is adapted to check if the categorized guided category comprises a list of required images ([0078], record one or a plurality of sequences of images) and if yes: - to display, on the display, instructions indicative of the list of required images ([0077], processing assembly 60 may also include various types of input/output hardware such as the visual display 326 and input device(s) 328 (e.g., keypad, keyboard, microphone etc.)) and/or - to compare the categories of recorded images in the image data against the list of required images.
Regarding claim 18, Parel discloses wherein the categorizer ([0071], image capturing members 51 are high-definition camera) further comprises a category selector adapted to receive manual input for attributing one or more categories to a dataset and/or to a current session ([0114], operable when selected by a practitioner to provide digital magnification and can allow the practitioner to select a region of interest or a single point, activating the digital magnification algorithm in stepwise fashion by selecting on the screen).
Regarding claim 19, Parel discloses further comprising a measurement unit adapted to measure at least one eye parameter of an eye being investigated and to generate measurement data indicative of the eye parameter ([0108], an electronic or digital caliper for acquiring measurements of portions of the patient’s eye), wherein the processing unit (60) is adapted to associate, in the report, the measurement data with the voice data and/or the image data ([0080], image data) and/or wherein the processing unit is adapted to associate ([0109], processing assembly 60 preferably comprises a setting memory structured to record the settings of the various components of the positioning assembly 70), in the report, voice data from the voice recorder and image data from the microscope as a function of the measurement data ([0057]-[0058], [0111], data transmitted over network 30 in 100 comprises information from ophthalmic device 10 and information from control device 20. Data from the ophthalmic device 10 includes at least image data of at least one of patient’s eyes).
Regarding claim 20, Parel discloses wherein said processing unit (60) comprises a categorizer ([0071], image capturing members 51 are high-definition camera) adapted to attribute the voice data and/or the image data of a current session ([0109], measurements could provide values of depth and curvature) and wherein the categorizer is adapted to select the subset of categories as a function of the measurement data ([0111], information related to the patient’s eyes and its structures as well as the abnormalities and changes detected).
Regarding claim 21, Parel discloses wherein the eye parameter comprises at least one of keratometry data of the eye, a cornea thickness of the eye ([0109], cornea thickness), a parameter indicative of a presence of a cataract in the eye, a pupil diameter of the eye, and/or an iris diameter of the eye, tear break-up time of the eye, anterior chamber depth ([0100], cornea, anterior chamber, iris, and lens of the eye), dimension and opacity of lesions an ulcers, anterior chamber angle, graded corneal staining, eyelid position.
Regarding claim 22, Parel discloses wherein the voice recorder ([0077], microphone) comprises at least one microphone ([0077], microphone) and wherein the microphone is arranged on the ophthalmic microscope ([0077], various types of input/output hardware).
Regarding claim 23, Parel discloses wherein the ophthalmic microscope (100) comprises a pivotal microscope housing (Fig 3, [0088], support structure such as a housing of the processing assembly 60 so that movement of the first positioning member 71 effects a change in the lateral position of components of the ophthalmic device 10), and wherein the microphone is arranged on the pivotal microscope housing (38) (Fig 3 shows 77 on the same structure of assembly 60 which is within device 10).
Regarding claim 24, Parel discloses wherein the microscope (100) comprises an ocular on the microscope housing (Fig 3 shows lens 52’ and 52’’ on top of the assembly within 60), and the microphone is arranged below the ocular (Fig 7 shows a microphone within assembly 50 below data capturing member 55).
Regarding claim 25, Parel discloses wherein the ophthalmic microscope comprises a display (display 326), with the pivotal microscope housing being pivotal in respect to the display (Fig 6, Fig 7, [0077]), and wherein the microphone ([0077], microphone) is arranged on a frame of the display (Fig 6, [0077], display 326 is part of assembly 60).
Regarding claim 26, Parel discloses further comprising at least one of: a detector adapted to detect the X-offset ([0060], ophthalmic device 10 can be operable to detect and sense the resolution of the display 21 of the control device 20 or multiple control devices 20), a detector adapted to detect the pivot angle.
Regarding claim 27, Parel discloses wherein the processing unit (60) is adapted to associate, in the report, voice data ([0098], convert voice commands of practitioner) from the voice recorder and image data from the microscope as a function of the keywords and/or key phrases ([0099], audio member 78 is configured to relay this verbal information to the patient so they may respond according to the practitioner’s instructions).
Regarding claim 28, Parel discloses wherein the categories are indicative of at least one of the following: -a part of an eye is being measured, - which eye is being measured, - what kind of pathology is being observed, - what kind of measurement is being carried out ([0064], eye examination and diagnosis of certain eye conditions), or - what is the purpose of a current session.
Regarding claim 30, Parel discloses an ophthalmic microscope assembly (Fig 3, [0049], ophthalmic imaging 100) comprising: a processing unit (60); an ophthalmic microscope with a camera (51); and a voice recorder ([0077], microphone), wherein the processing unit (60) is adapted to associate, in a report, voice data ([0098], convert the voice commands) from the voice recorder and image data ([0080], image data) from the microscope ([0057]-[0058], [0111], data transmitted over network 30 in 100 comprises information from ophthalmic device 10 and information from control device 20. Data from the ophthalmic device 10 includes at least image data of at least one of patient’s eyes), wherein the microscope (10 is a biomicroscope) is adapted to send operating data indicative of one or more operating parameters of the microscope ([0064], used to study living tissue) to the processing unit (60), and wherein the processing unit (60) is adapted to:- associate the operating data ([0058], positional information regarding the ophthalmic device) with at least one of the voice data ([0098], convert the voice commands) and the image data ([0080], image data) and/or - to associate, in the report, voice data from the voice recorder and image data from the microscope as a function of the operating data, and wherein the processing unit (60) is adapted to associate, in the report, voice data from the voice recorder ([0098], convert the voice commands) and image data ([0080], image data) from the microscope (10) as a function of the operating data ([0058], positional information regarding the ophthalmic device).
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.
The factual inquiries 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.
This application currently names joint inventors. 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. 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.
Claim(s) 15-17 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Parel (WO 2020180729 A1) in view of Casas (20170108685).
Regarding claim 15, Parel discloses the invention as described within claim 8 but does not teach wherein the processing unit comprises a storage storing a plurality of report templates, a report generator adapted to generate the report as a function of one of the report templates. However, within a similar endeavor, Casas teaches wherein the processing unit ([0032], processor) comprises a storage ([0069], storage system) storing a plurality of report templates ([0059], storing, by a computer at a first location, one or more presentation templates), a report generator adapted to generate the report as a function of one of the report templates ([0057], generating a presentation on the evaluation of a specimen at a digital optical device). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the microscope system of Parel with the processing components of Casas for the purpose of providing enhanced digital microscopy that allow for a user to view and analyze the saved images of a specimen (Casas, [0044]).
Regarding claim 16, Parel in view of Casas discloses the invention as described within claim 15 and Casas further teaches wherein the report templates ([0059], storing, by a computer at a first location, one or more presentation templates) comprise placement instructions indicative of a position of a text sequence of the voice data and/or an image of the image data in the report ([0069], acquired image of the specimen is saved to a storage system and/or displayed), wherein the placement information comprises category information ([0059], presentation templates), and the report generator is adapted to use the placement information for placing a given voice sequence or image in the report ([0082], digital processing device includes one or more hardware central processing units (CPUs) or general purpose graphics processing units (GPGPUs) that carry out the device's functions) depending on a category attributed to the given voice sequence or image mages and on the category information ([0084], operating system is, for example, software, including programs and data, which manages the device's hardware and provides services for execution of application). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the microscope system of Parel with the processing components of Casas for the purpose of providing enhanced digital microscopy that allow for a user to view and analyze the saved images of a specimen (Casas, [0044]).
Regarding claim 17, Parel in view of Casas discloses the invention as described within claim 15 and Casas further teaches wherein the report generator is adapted to at least one of: A) provide a user-operatable selection mechanism for a user to select a template ([0056], user instructs a computer controlling the digital optical device to advance the field of view) or B) based on the category data, at least one of: - select one template or - display one or more templates for selection by the user. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the microscope system of Parel with the processing components of Casas for the purpose of providing enhanced digital microscopy that allow for a user to view and analyze the saved images of a specimen (Casas, [0044]).
Regarding claim 29, Parel in view of Casas discloses the invention as described within claim 15 and Casas further teaches wherein the report generator is adapted to at least one of: select the one of the report templates as a function of category data attributed to the current session ([0056], user instructs a computer controlling the digital optical device to advance the field of view) or select the one of the report templates as a function of user input. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the microscope system of Parel with the processing components of Casas for the purpose of providing enhanced digital microscopy that allow for a user to view and analyze the saved images of a specimen (Casas, [0044]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yoshida (20220117486), Lee (20210244271), Siegel (20200211233), and Su (6361167) are examples of an ophthalmic apparatus incorporating an image capturing device and processor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sharrief I Broome whose telephone number is (571)272-3454. The examiner can normally be reached Monday-Friday 8am-5pm, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ricky Mack can be reached at 571-272-2333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Sharrief I. Broome
Primary Examiner
Art Unit 2872
/SHARRIEF I BROOME/ Primary Examiner, Art Unit 2872