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 .
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 8 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.
The term “about” in claim 8 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what range the limitation “about 1 second” encompasses. Clarification is requested.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 19 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because "computer-readable storage medium" is not a process, machine, manufacture, or composition of matter. "Computer-readable storage medium" is not tangible, as it is not tied to a structural element. To overcome this 35 U.S.C. 101 rejection, Examiner suggests amending "computer-readable storage medium" to "a non-transitory product comprising a computer-readable storage medium" or the like.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of structural elements, including a display screen. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
wherein the FAS is configured to:
present a visual target on the display screen at a primary fixation point; and
calculate a numeric floater severity score using the feedback signals, wherein the numeric floater severity score quantifies the subjective severity of the perceived floater
set forth a judicial exception. The presenting step describes a concept of managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). Thus, the claims is drawn to Organizing Human Activity, which is an Abstract Idea. The calculating step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion) and a concept of mathematical relationships, mathematical formulas or equations, mathematical calculations. Thus, the claim is drawn to a Mental Process and Mathematical Concept, which are also Abstract Ideas.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites calculating a numeric floater severity score using the feedback signals, wherein the numeric floater severity score quantifies the subjective severity of the perceived floater, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The calculating of the numeric floater severity score does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the calculated numeric floater severity score, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional elements/step of:
a display screen;
a patient-operated feedback device; and
a floater assessment system (FAS) in communication with the display screen and the patient-operated feedback device; and
wherein the FAS is configured to: receive feedback signals from the patient-operated feedback device in response to an activation of the patient-operated feedback device by the patient, the feedback signals being indicative of a location of the patient-perceived floater relative to the visual target.
The receiving step is a well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the receiving step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited patient-operated feedback device is a generic sensor configured to perform pre-solutional data gathering activity, the display screen is configured to perform insignificant extra-solution activity, and the FAS is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The same rationale applies to claims 12 and 19.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2, 5, and 13 recite steps that are pre-solution activity necessary to perform the Abstract Idea. Claims 3, 4, 9, 14, and 17 recite additional elements that are not significantly more. Claims 6-8, 10, 11, 16, 18, and 20 recite steps that add to the Abstract Idea. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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, 2, 4, 5, 8-13, 15, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Katchinskiy et al. ‘001 (US Pub No. 2024/0269001, foreign priority date 06 May 2022).
Regarding claim 1, Katchinskiy et al. ‘001 teaches an automated system for assessing a subjective severity of a patient-perceived floater in an eye of a patient, the system comprising:
a display screen (Fig. 13 display 1318 and [0123]);
a patient-operated feedback device ([0123]; “The doctor can select a floater being tracked by the system using a user interface. The floater can be highlighted in the patient's vision, possible using the OCT light or by changing a portion of the screen to highlight the floater. Using this technique, the patient can guide the doctor quickly to select the correct floater.”); and
a floater assessment system (FAS) in communication with the display screen and the patient-operated feedback device (Fig. 13 device 1304 and [0121]), wherein the FAS is configured to:
present a visual target on the display screen at a primary fixation point (Fig. 14 gaze target 1410 and [0125]);
receive feedback signals from the patient-operated feedback device in response to an activation of the patient-operated feedback device by the patient, the feedback signals being indicative of a location of the patient-perceived floater relative to the visual target ([0123]; “The doctor can select a floater being tracked by the system using a user interface. The floater can be highlighted in the patient's vision, possible using the OCT light or by changing a portion of the screen to highlight the floater. Using this technique, the patient can guide the doctor quickly to select the correct floater.”); and
calculate a numeric floater severity score using the feedback signals, wherein the numeric floater severity score quantifies the subjective severity of the perceived floater ([0123]; “Other techniques can be used to identify particular floaters that are symptomatic or bothersome to the patient including using the display to present the user with text to read. The speed of reading, or the ability to read can be used as an indication of the severity of an SVO being tracked that is in the patient's view of the text being read.”).
Regarding claim 2, Katchinskiy et al. ‘001 teaches wherein the FAS is configured to present the visual target on the display screen solely at the primary fixation point (Fig. 14 gaze target 1410 and [0125]).
Regarding claim 4, Katchinskiy et al. ‘001 teaches generating, via the FAS based on the numeric floater severity score, a digital output file that characterizes the patient-perceived floater as being potentially medically significant ([0157]; Being a good candidate for laser treatment based on the severity of floaters is interpreted as “potentially medically significant.”).
Regarding claim 5, Katchinskiy et al. ‘001 teaches wherein the FAS is configured to sequentially present the visual target at multiple secondary fixation points located eccentrically with respect to primary fixation point, according to a predetermined assessment sequence during which the visual target is sequentially presented above, to each side of, and below the primary fixation point (Fig. 14 target 1412 and [0125]).
Regarding claim 8, Katchinskiy et al. ’001 teaches wherein the FAS is configured to dynamically transition the visual target between the primary fixation point and the secondary fixation points such that the visual target does not dwell at the primary fixation point or any of the secondary fixation points for more than about 1 second ([0125]).
Regarding claim 9, Katchinskiy et al. ‘001 teaches wherein the visual target includes a grayscale target arranged on a white background ([0123]; “white screen or grid”).
Regarding claim 10, Katchinskiy et al. ‘001 teaches an interface device, wherein the FAS is configured to select a visual characteristic or parameter of the visual target in response to input signals from the interface device ([0104]; “contrast”).
Regarding claim 11, Katchinskiy et al. ‘001 teaches wherein the characteristic or parameter of the visual target includes a contrast level of the visual target ([0104]; “contrast”).
Regarding claims 12, 13, 15, and 17-19, Katchinskiy et al. ‘001 teaches a method for assessing a subjective severity of a patient-perceived floater in an eye of a patient, the method comprising: the claimed steps and a computer-readable storage medium on which is recorded instructions for assessing a subjective severity of a patient-percieved floater in an eye of a patient, wherein execution of the instructions by a processor of a floater assessment system (FAS) causes the processor to: perform the claimed steps as claims 12 and 19 are analogous to claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Katchinskiy et al. ‘001 in view of Herekar et al. ‘519 (US Pub No. 2019/0105519).
Regarding claim 3, Katchinskiy et al. ‘001 teaches all of the elements of the current invention as mentioned above except for wherein the patient-operated feedback device includes a multi-axis joystick, and wherein the FAS is configured to display and move a cursor on the display screen in response to motion of the multi-axis joystick to indicate the location of the perceived floater relative to the visual target.
Herekar et al. ‘519 teaches the user may for example input the desired treatment zones using a touch-screen to select the target zones directly on the displayed image or by using a joystick or mouse to point a cursor at the target zones. For example, the HIFU system may be used to target floaters in the eye. Real-time image(s) of the eye may be acquired and displayed for the user (for example a doctor) to view. The floaters may be identified by the user and selected using a touch screen. The processor may then direct the HIFU scanner to scan the HIFU beam to the targeted treatment zones comprising the floaters ([0315]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patient-operated feedback device of Katchinskiy et al. ‘001 to include a multi-axis joystick, and wherein the FAS is configured to display and move a cursor on the display screen in response to motion of the multi-axis joystick to indicate the location of the perceived floater relative to the visual target as Herekar et al. ‘519 teaches that this will aid in selecting the desired treatment zones.
Regarding claim 14, Katchinskiy et al. ‘001 teaches all of the elements of the current invention as mentioned above except for wherein receiving feedback signals from the patient-operated feedback device includes receiving the feedback signals from a joystick and a push button device.
Herekar et al. ‘519 teaches the user may for example input the desired treatment zones using a touch-screen to select the target zones directly on the displayed image or by using a joystick or mouse to point a cursor at the target zones. For example, the HIFU system may be used to target floaters in the eye. Real-time image(s) of the eye may be acquired and displayed for the user (for example a doctor) to view. The floaters may be identified by the user and selected using a touch screen. The processor may then direct the HIFU scanner to scan the HIFU beam to the targeted treatment zones comprising the floaters ([0315]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the receiving feedback signals from the patient-operated feedback device of Katchinskiy et al. ‘001 to include receiving the feedback signals from a joystick and a push button device as Herekar et al. ‘519 teaches that this will aid in selecting the desired treatment zones.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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