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 .
The current application has the priority date of 03/25/2022 according to the priority chain on the record.
Claim Status
As per preliminary claim amendment dated 09/25/2024, claims 1-12 and 14-21 are pending; claim 13 has been cancelled, claims 20-21 have been newly added, and all pending claims have been amended.
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 limitations are:
“image processing (device)” in claims 1, 12, 14 and 17
“personal/measurement data acquisition device” in claims 1, 3-4, 12, 14 and 16
“self-learning device” in claims 10 and 17
“inspection device” in claim 9
“tracking device” in claim 6
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 Objection
Claims 1-12 and 14-21 are objected to because of the following informalities:
Claim 1, line 5 “image processing” is missing the word ‘device’ in the end
Claim 12, lines 6-7 “current structured image data of the retina from the of the retina captured by the camera” should be amended to remove repeated limitations.
The claims inconsistently uses the terms “planning data” and “planning dataset”
The current claims appear to have been translated from German, and contain terms not traditionally used in English. The Applicant is sincerely requested to amend through the claim terms for clarity.
Appropriate correction is required.
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.
Claim 12 is 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.
Regarding claim 12, in the “a processing device” claim clause, the limitation “personal data of the data” is indefinite as it is what “data” this is referring to.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-9, 11-12, 14-16 and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Claus et al. US 2016/0278983 A1 (hereinafter “Claus”).
Regarding claim 1, Claus discloses a system ([0027] and Fig. 1: 100 system for optimizing laser photocoagulation) for generating planning datasets for tissue treatment of a retina of an eye of a patient using of a laser ([0027] system for determining appropriate laser parameters for laser treatment on ocular/retinal data), the system comprising:
a camera (imaging device 130 e.g. OCT) configured to continuously acquire images of the retina ([0029-0030] OCT acquires images of ocular tissue, e.g. retina);
an image processing (device) (see Fig. 3 flow diagram of the operation of imaging device 130) configured to generate and provide current structured image data of the retina from images captured by the camera ([0029, 0030] detecting retinal topography data; also see Fig.3: 308-detect abnormal retinal features based on generated metric, also see [0050-0053]);
a personal data acquisition device ([0042-0043] GUI 190 for receiving user input; or memory 170 storing patient image data) configured to at least one of acquire or provide personal data of patient (see [0060] “the one or more thresholds may be selected based on empirical data. For example, a collection or database of patient retinal data may be used to determine normalized or baseline retinal data. This baseline data may be used to obtain threshold values to detect retinal abnormalities.” [0059-0060] describes detecting and storing patient-specific data, taken to encompass “personal data of the patient” in the claim); and
a processing device (laser control device 110 comprising processor 160) configured to assign one or more planning datasets for the tissue treatment to the current structured image data of the retina and to the personal data of the patient ([0048] “abnormalities may be detected automatically by the system 100 according to one or more algorithms”), with specifications for the assignment of the one or more planning datasets (i.e. treatment plan, any parameter concerning treatment plan is taken to encompass “planning dataset” in the claim, e.g. treatment location, laser parameters, etc. see [0027-0028]) to the current structured image data and the personal data of the patient being stored in the processing device ([0046: last sentence] memory device 170 stores patient imaging data), wherein the specifications include one or more patterns or rules. ([0057] predetermine rules and thresholds for determining retinal abnormality; also see [0036: 1st sentence] memory stores algorithms, rules, operational parameters etc.)
Regarding claim 2, Claus discloses the system according to claim 1, wherein a patient category selected from a plurality of predefined patient categories ([0055-0056] defining an abnormality category/type, from a plurality of categories, e.g. break, a hole, a tear, a dialysis, a growth, a protrusion, a depression, a region with subretinal fluid, etc.) is assigned to the patient based at least in part on the personal data or the acquired data, and the specifications (e.g. laser treatment plan) and wherein the personal data are determined or influenced by the assigned patient category. ([0038] “the laser control application 180 may provide instructions to obtain one or more images of an ocular tissue for treatment, identify one or more areas of the ocular tissue for laser photocoagulation treatment, generating a laser treatment plan, and delivering laser treatment to the one or more areas of the ocular tissue.” Also see [0086])
Regarding claim 3, Claus discloses the system according to claim 1, wherein the personal data acquisition device (GUI 190 or memory 170) is configured to acquire and provide at least one of: i) diagnostic data, ii) indication data, iii) data of a pre-treatment carried out, iv) previously known physiological data of the patient, or v) one or more existing images of the retina of the patient stored outside the system. ([0042] medical practitioner uses GUI to provide information associated with a medical procedure; [0047] GUI displays retinal images, [0046] memory stores imaging data; [0068, 0077] memory stores treatment location and treatment plan)
Regarding claim 4, Claus discloses the system according to claim 1, further comprising: a measurement data acquisition device including one or more sensor devices (e.g. sensors, microscope 140) for acquiring and providing physiological data of the patient ([0037] “Control of the laser parameters may be premised on information inputted by a user and/or data received into the system, such as by one or more sensors” and [0048] “ other types of sensors to detect or generate other types of data may be used to detect retinal abnormalities.” This is taken to encompass sensors detecting physiological data in the claim), wherein a first portion of the physiological data which depends on a respective location on the retina ([0048]), wherein a second portion of the physiological data does not depend on a location on the retina ([0037]), and wherein the processing device (110) is configured to take the acquired or provided physiological data of the patient into account when assigning planning datasets. ([0037, 0048] sensor detected data is used to detect retinal abnormalities, then used for generating treatment plan)
Regarding claim 5, Claus discloses the system according to claim 1, further comprising: a display module (display 150) to display a graphical representation of the one or more planning datasets within an image of the retina currently captured by the camera. ([0047] “the image 200 may be displayed on display 150… the image 200 may form part of or otherwise be shown via GUI 190. The image of retina 210 may be obtained by the microscope 140”)
Regarding claim 6, Claus discloses the system according to claim 5, further comprising: a tracking device (retinal tracking device) configured to cause the display of the one or more planning datasets to be tracked when the image of the retina currently captured by the camera is displaced. ([0068] “registration of the selected treatment locations and the real-time image of the retina 210 may be obtained with a retinal tracking device”; also see [0069-0070])
Regarding claim 7, Claus discloses the system according to claim 4, wherein the processing device has a storage device (memory 170) configured to store the personal data of the patient, the one or more planning datasets assigned to the patient, the physiological data, or one or more manual modifications made to the one or more planning datasets. ([0046] memory stores imaging data; [0068, 0077] memory stores treatment location and treatment plan)
Regarding claim 8, Claus discloses the system according to claim 4, wherein the processing device has a storage device (memory 170) which is configured to store at least one of the personal data of the patient, the current structured image data, or images of the patient's retina generated with the one or more planning datasets assigned to the patient, and to store the physiological data ([0046] memory stores imaging data; [0068, 0077] memory stores treatment location and treatment plan) and one or more manual modifications made to the one or more planning datasets. ([0085] “The treatment locations automatically identified by the system, such as system 100, may be presented to a user, such as a surgeon, for review and/or modification prior to further development of further treatment options.”)
Regarding claim 9, Claus discloses the system according to claim 4, further comprising: an inspection device (Fig. 12) configured to, after a treatment of the retina is performed, at least one of acquire or provide data on an effect of the treatment. ([0120] “The treatment plan may be updated as the procedure progresses, such as by tracking which selected treatment locations have been treated and which remain untreated. At the conclusion of the treatment, a user may be notified, such as with an audible and/or visual notification.”; [0123] “upon treatment of a selected treatment location, a representation of the selected treatment location may be updated both visually and within the treatment plan to indicate that treatment of that selected treatment location has occurred.”)
Regarding claim 11, Claus discloses the system according to claim 1, wherein the one or more planning datasets (i.e. treatment plan) include planning data of at least one of, a laser parameter, location data for laser treatment, one or more treatment patterns, location data for one or more regions excluded from laser treatment, or one or more target values for measurement data. ([0005] treatment location and treatment parameter, e.g. “The treatment parameters may include one of a location to apply a treatment, a size of the location to be treated, locations excluded from treatment, and a laser power to be used for treatment”; also see [0027-0028])
Regarding claim 12, Claus discloses a device ([0027] and Fig. 1: 100 system comprising laser device 1control device 110 and laser delivery device 120) for generating one or more planning datasets for tissue treatment of a retina of an eye ([0027] system for determining appropriate laser parameters for laser treatment on ocular/retinal data), the device comprising:
a camera (imaging device 130 e.g. OCT), configured to continuously acquire images of the retina;
an image processing device (see Fig. 3 flow diagram of the operation of imaging device 130) configured to generate and provide current structured image data of the retina from the of the retina captured by the camera ([0029, 0030] detecting retinal topography data; also see Fig.3: 308-detect abnormal retinal features based on generated metric, also see [0050-0053]);
a personal data acquisition device ([0042-0043] GUI 190 for receiving user input; or memory 170 storing patient image data) continue to at least one of acquire or provide personal data of a patient (see [0060] “the one or more thresholds may be selected based on empirical data. For example, a collection or database of patient retinal data may be used to determine normalized or baseline retinal data. This baseline data may be used to obtain threshold values to detect retinal abnormalities.” [0059-0060] describes detecting and storing patient-specific data, taken to encompass “personal data of the patient” in the claim);
a processing device (laser control device 110 comprising processor 160) configured to assign the one or more planning datasets to the current structured image data of the retina and to the personal data of the data(set) ([0048] “abnormalities may be detected automatically by the system 100 according to one or more algorithms”), wherein one or more specifications for the assignment of planning data (i.e. treatment plan, any parameter concerning treatment plan is taken to encompass “planning dataset” in the claim, e.g. treatment location, laser parameters, etc. see [0027-0028]) to structured image data and the personal data of the patient are stored in the processing device ([0046: last sentence] memory device 170 stores patient imaging data), wherein the specifications include one or more patterns or rules. ([0057] predetermine rules and thresholds for determining retinal abnormality; also see [0036: 1st sentence] memory stores algorithms, rules, operational parameters etc.); and
a modification device (GUI 190 [0042-0043] medical practitioner enters modification using GUI) configured to enable manual modification of a planning dataset. ([0085] “The treatment locations automatically identified by the system, such as system 100, may be presented to a user, such as a surgeon, for review and/or modification prior to further development of further treatment options.”; also see [0067] modification to treatment location; [0123-0124] modification to treatment plan)
Regarding claim 14, this claim is rejection by Claus under the same rationale as discussed to claim 1 above. Claus discloses a method for generating one or more planning datasets for tissue treatment of a retina of an eye of a patient (see [0003-0008] photocoagulation treatment of retina).
Regarding claim 15, Claus discloses the method according to claim 14, wherein the assigned one or more planning datasets are changed manually after assignment by the processing device. ([0085] “The treatment locations automatically identified by the system, such as system 100, may be presented to a user, such as a surgeon, for review and/or modification prior to further development of further treatment options.”)
Regarding claim 16, this claim is rejected by Claus under the same rationale as discussed to claim 4 above.
Regarding claim 18, this claim is rejected by Claus under the same rationale as discussed to claim 11 above.
Regarding claim 19, Claus discloses the method according to claim 14, further comprising: implementing a treatment using the one or more planning datasets in a treatment device using a treatment laser. (Fig.1: laser delivery device 120; see [0029-0030])
Regarding claim 20, Claus discloses the system according to claim 4, further comprising: a modification device configured (GUI 190 [0042-0043] medical practitioner enters modification using GUI) to allow manual modification of the one or more planning datasets. ([0085] “The treatment locations automatically identified by the system, such as system 100, may be presented to a user, such as a surgeon, for review and/or modification prior to further development of further treatment options.”; also see [0067] modification to treatment location; [0123-0124] modification to treatment plan)
Regarding claim 21, this claim is rejected by Claus under the same rationale as discussed to claim 11 above.
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 10 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Claus as applied to claims 1 and 14 above, and in view of Celenk US 2018/0235467 A1 (hereinafter “Celenk”).
Regarding claim 10, Claus teaches the system according to claim 9, wherein the processing device has algorithms for detecting abnormalities from images of retinal tissue, but does not disclose the processing device is configured as a self-learning device.
However Celenk, another prior art reference in the analogous art of devices and methods for processing retinal images for diagnosing abnormalities (Abstract; [0004] laser photocoagulation ). Celenk specifically discloses a processing device (CPU) for that is configured as a self-learning device ([0205] artificial neural network/ANN, Support vector machines/SVM), wherein to assign the one or more planning datasets (identifying abnormalities/features), includes assigning one or more target values (e.g. diabetic and/or macular degeneration, etc. and recommending a particular treatment for diabetic and/or macular degeneration or pre-diabetic and/or macular degeneration condition; and see [0202, 0205]) for measurement data to the personal data to and at least one of the structured image data, or the measured physiological data of a patient, and wherein the processing device is trained by having specified for, in each case for one patient, at least data from: the personal data; the structured image data; the measured physiological data; the assigned planning data; the target values for measurement data; one or more manual changes to planning data; and the data on the effect of the treatment. ([0205, 0209-0210] classification based on retinal data, and genetic data; also see Figs. 1, 8, 14, 30 and 31). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Claus to implement the ANN and SVM taught in Celenk, the motivation for doing so is to implement advance processing to retinal images in addition to a practitioner’s judgement (Celenk: [0014, 0073-0076]).
Regarding claim 17, this claim is rejected by Claus in view of Celenk under the same rationale as discussed to claim 10 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
June 24, 2026
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