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 .
Priority
This application is a Continuation of U.S. Patent Application No. 18/278,959.
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 6 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.
Claim 6 recites the limitation "the alert". There is insufficient antecedent basis for this limitation in the claim.
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.
The broadest reasonable interpretation of a claim drawn to a computer readable medium covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. § 101, Aug. 24, 2009; p. 2.
Claim 8 is drawn to such a computer readable medium that covers both transitory and non-transitory embodiments but may be amended to narrow the claim to cover only statutory embodiments by adding the limitation "non-transitory" to the claim.
Claims 1 and 5-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more without significantly more. The claim(s) recite(s) a recovery level estimation device, method, and recording medium. This judicial exception is not integrated into a practical application because the steps do not add meaningful limitations to be considered specifically applied to a particular technological problem to be solved. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps of the claimed invention can be done mentally and/or mathematical concepts performed by a generic computer.
According to the USPTO guidelines, a claim is directed to non-statutory subject matter if:
STEP 1: the claim does not fall within one of the four statutory categories of invention (process, machine, manufacture or composition of matter), or
STEP 2: the claim recites a judicial exception, e.g. an abstract idea, without reciting additional elements that amount to significantly more than the judicial exception, as determined using the following analysis:
STEP 2A (PRONG 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Using the two-step inquiry, it is clear that claims 1 and 5-8 are directed to an abstract idea as shown below:
STEP 1: Do the claims fall within one of the statutory categories? YES. Claim(s) 1-10 are directed to a device, a method, and a non-transitory computer readable storage medium.
STEP 2A (PRONG 1): Is the claim directed to a law of nature, a natural phenomenon or an abstract idea? YES , the claims are directed toward a mental process and mathematical concepts (i.e. abstract idea).
With regard to STEP 2A (PRONG 1), the guidelines provide three groupings of subject matter that are considered abstract ideas:
Mathematical concepts — mathematical relationships, mathematical formulas or equations, mathematical calculations;
Certain methods of organizing human activity — fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
Mental processes — concepts that are practicably performed in the human mind (including an observation, evaluation, judgment, opinion).
Claims 1, 7, and 8 comprise a mental process that can be practicably performed in the human mind and, therefore, is an abstract idea.
“present, via a display, a task requiring a patient to track a moving light spot with the eyes” (insignificant pre-solution activity of displaying);
“acquire the images of the eyes the patient presented the task captured by the camera” (insignificant pre-solution activity of data gathering);
“extract the eye movement feature concerning a visual field defect information based on the images” (mental process including an observation, evaluation, judgment, opinion, can be done mentally in the human mind by evaluating the image data);
“estimate a recovery level of the patient based on the eye movement feature by using a recovery level estimation model which has been learned by machine learning in advance” (mental process including an observation, evaluation, judgment, opinion, can be done mentally in the human mind by evaluating the extracted features).
Claim 5 comprises a mental process that can be practicably performed in the human mind and, therefore, is an abstract idea.
“present the task by outputting the moving light spot over time in a light point display area” (insignificant pre-solution activity of displaying).
Claim 6 comprises a mental process that can be practicably performed in the human mind and, therefore, is an abstract idea.
“output the alert with respect to a medical professional in order for the medical professional to optimize a rehabilitation plan of the patient” (insignificant post-solution activity of displaying).
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application? NO, the claims do not recite additional elements that integrate the judicial exception into a practical application.
With regard to STEP 2A (prong 2), whether the claim recites additional elements that integrate the judicial exception into a practical application, the guidelines provide the following exemplary considerations that are indicative that an additional element (or combination of elements) may have integrated the judicial exception into a practical application:
an additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
While the guidelines further state that the exemplary considerations are not an exhaustive list and that there may be other examples of integrating the exception into a practical application, the guidelines also list examples in which a judicial exception has not been integrated into a practical application:
an additional element merely recites the words “apply it” (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea;
an additional element adds insignificant extra-solution activity to the judicial exception; and
an additional element does no more than generally link the use of a judicial exception to a particular technological environment or field of use.
Claim(s) 1 and 5-8 do not recite any of the exemplary considerations that are indicative of an abstract idea having been integrated into a practical application as generic computer components can perform the steps.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO, the claims do not recite additional elements that amount to significantly more than the judicial exception.
With regard to STEP 2B, whether the claims recite additional elements that provide significantly more than the recited judicial exception, the guidelines specify that the pre-guideline procedure is still in effect. Specifically, that examiners should continue to consider whether an additional element or combination of elements:
adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; or simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Claim(s) 1 and 5-8 does/do not recite any additional elements that are not well-understood, routine or conventional. The use of a computer for storing, executing and processing, is a routine, well-understood and conventional process that is performed by computers.
Thus, since Claim(s) 1 and 5-8 is/are: (a) directed toward an abstract idea, (b) do not recite additional elements that integrate the judicial exception into a practical application, and (c) do not recite additional elements that amount to significantly more than the judicial exception, it is clear that Claim(s) 1 and 5-8 is/are not eligible subject matter under 35 U.S.C 101.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 6-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-8 of copending Application No. 18/485,782 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-8 are rejected under 35 U.S.C. 103(a) as being unpatentable over Macknik et al. (US 2016/0106358), cited in the IDS dated 10/12/23, in view of Zidan et al. (US 2020/0397288).
Regarding claims 1, 7, and 8, Macknik discloses a recording medium storing a program, a method, and a recovery level estimation device comprising:
a memory storing instructions (see Fig. 4 and paras 30-31, memory 42); and
one or more processors (see Fig. 4 and paras 30-31, processor(s) 38) configured to execute the instructions to:
present, via a display, a task to a patient for extracting eye movement feature (see paras 18 and 22, visual stimuli or a visual task is presented to the patient);
acquire the images of the eyes the patient presented the task captured by the camera (see paras 17-18 and 30-31, eye tracking device 32 acquires images of patient’s eyes);
extract the eye movement feature concerning a visual field defect information based on the images (see paras 16-20 and 23, eye movement features, such as microsaccades, are extracted); and
estimate the recovery level of the patient based on the eye movement feature by using a recovery level estimation model (see paras 20 and 28, based on extracted eye movement features/dynamics, a trained algorithm can generate a report regarding the response to treatment or assessment of progression, both are considered recovery level estimations).
Macknik does not disclose expressly a task requiring a patient to track a moving light spot with the eyes and a recovery level estimation model which has been learned by machine learning in advance.
Zidan discloses a task requiring a patient to track a moving light spot with the eyes (see Figs. 34-36 and paras 193, 196, 208, and 258, a high-speed camera captures images of a patient’s eyes 161 and 163 during a test in which a patient is instructed to follow a red dot with their eyes).
a recovery level estimation model which has been learned by machine learning in advance (see paras 159, 185, 188, 223-228, 236, 238, 247-248, 250-251, and 265-266, artificial intelligence, such as neural networks, are trained with sensed parameters from ocular testing of patients, historical patient data can be stored and used for comparison to determine abnormality progression, or the other side of the same coin, abnormality regression, or put another way, rehabilitation recovery).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the trained neural network, as described by Zidan, with the system of Macknik.
The suggestion/motivation for doing so would have been to provide enhanced effectiveness, reliability, accuracy, and efficiency in detecting eye abnormalities (para 81 of Zidan).
Therefore, it would have been obvious to combine Zidan with Macknik to obtain the invention as specified in claims 1, 7, and 8.
Regarding claim 2, Zidan further discloses wherein the one or more processors are configured to: estimate the recovery level concerning the visual field defect information of the patient by detecting abnormality caused by a cerebral infarction (see paras 115 and 136, disorders, such as cerebrovascular (stroke), are detected).
Regarding claim 3, Zidan further discloses wherein the one or more processors are configured to: acquire the visual field defect information by calculating a size of an area where a tracking failure occurs frequently (see para 103, an area of interest is used to detect saccades).
Regarding claim 4, Zidan further discloses wherein the one or more processors are configured to: acquire the visual field defect information by counting a square with high frequency of a tracking failure in light spot display area which is divided into virtual squares (see Figs. 34-36 and paras 193, 196, 208, and 258, a high-speed camera captures images of a patient’s eyes 161 and 163 during a test in which a patient is instructed to follow a red dot with their eyes).
Regarding claim 5, Zidan further discloses wherein the one or more processors are configured to: present the task by outputting the moving light spot over time in a light point display area (see Figs. 34-36 and paras 193, 196, 208, 258, and 261, a high-speed camera captures images of a patient’s eyes 161 and 163 during a test in which a patient is instructed to follow a red dot with their eyes, the images are timestamped).
Regarding claim 6, Macknik further discloses wherein the one or more processors are configured to: output the alert with respect to a medical professional in order for the medical professional to optimize a rehabilitation plan of the patient (see paras 19-20 and 28, a report is generated regarding the response to treatment or assessment of progression, thresholds can be used to determine defects, such as SWJ).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK R MILIA whose telephone number is (571)272-7408. The examiner can normally be reached Monday-Friday, 8am-5pm.
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/MARK R MILIA/ Primary Examiner, Art Unit 2681