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 Objections
Claims 2-14 and 15-20 are objected to because of the following informalities: a period is missing at the end of the claim. Appropriate correction is required.
Claims 15-20 are objected to because of the following informalities: replace “method” with --system--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: a “;” should be at the end of “i”, “ii” and steps b) through i). Appropriate correction is required.
Claim 14 is objected to because of the following informalities: a “;” should be at the end steps a) through c) and at the end of “i” through “iv”. Appropriate correction is required.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,934,933 (hereinafter ‘933). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Current Application ‘933
Claim 1:
a) an ensemble of machine-learning models each of which consists of:
i. a feature extraction mechanism
ii. a classification mechanism
b) a step to split the input data into training and test sets
c) a step to initialize the weights
d) for each model, a step in which the feature extraction mechanism yields a feature vector or other object encoding the ophthalmic image features
e) for each model, a step in which the feature vector is passed into the classified to yield a class prediction
f) for each model, a mechanism to iteratively update the weights to reduce class prediction error
g) for each model, a stopping mechanism for the iteration
h) a step to compare and rank the models based on their performance on a test dataset
i) a step to assign weights to the various models in the ensemble
j) given a subject ophthalmic image, a step to compute the weighted-average of the class predictions of the plurality of models, and to choose the ophthalmic image class based on this weighted-averaging step.
Claim 1:
a) an ensemble of machine-learning models each of which consists of:
i. a feature extraction mechanism; and
ii. a classification mechanism;
b) a step to split the input data into training and test sets;
c) a step to initialize the weights;
d) for each model, a step in which the feature extraction mechanism yields a feature vector or other object encoding the ophthalmic image features;
e) for each model, a step in which the feature vector is passed into the classification mechanism to yield a class prediction;
f) for each model, a mechanism to iteratively update the weights to reduce class prediction error;
g) for each model, a stopping mechanism for the iteration;
h) a step to compare and rank the models based on their performance on a test dataset: i) a step to assign weights to the various models in the ensemble; and
j) given a subject ophthalmic image, a step to compute the weighted-average of the class predictions of the plurality of models, and to choose the ophthalmic image class based on this weighted-averaging step.
Current Application ‘933
Claim 14:
a) a system to capture or retrieve an ophthalmic image
b) a computer or computing environment consisting of processing and storage components
c) a trained weighted-ensemble of machine learning models stored on the storage component
d) executable commands stored on the storage component such that, upon command,
i. an ophthalmic image is obtained
ii. the ophthalmic image is stored in the storage components
iii. the ophthalmic image is retrieved and a classified by passage through the trained weighted-ensemble
iv. the image class such as disease state and stage is provided as output
v. the image class can be transmitted over a network to a third party for storage, further interpretation, and/ or appropriate action.
Claim 14:
a) a system to capture or retrieve an ophthalmic image;
b) a computer or computing environment consisting of processing and storage components;
c) a trained weighted-ensemble of machine learning models stored on the storage component; and
d) executable commands stored on the storage component such that, upon command,
i. an ophthalmic image is obtained;
ii. the ophthalmic image is stored in the storage components;
iii. the ophthalmic image is retrieved and classified by passage through the trained weighted-ensemble;
iv. the image class such as disease state and stage is provided as output; and
v. the image class can be transmitted over a network to a third party for storage, further interpretation, and/or appropriate action.
NOTE: Claim 14 of the current application is identical to claim 14 of ‘933.
Claims 2-13 and 15-20 of the current application correspond to claims 2-13 and 15-20 of ‘933.
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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The limitations, under their broadest reasonable interpretation, cover mental process (concept performed in a human mind, including as observation, evaluation, judgment, opinion, organizing human activity and mathematical concepts and calculations).
Claim 1 recites A method for weighted-ensemble training of machine-learning models to classify ophthalmic images according to features such as disease type and state; where the method comprises of: a) an ensemble of machine-learning models each of which consists of:i. a feature extraction mechanism ii. a classification mechanism b) a step to split the input data into training and test sets c) a step to initialize the weights d) for each model, a step in which the feature extraction mechanism yields a feature vector or other object encoding the ophthalmic image features e) for each model, a step in which the feature vector is passed into the classified to yield a class prediction f) for each model, a mechanism to iteratively update the weights to reduce class prediction error g) for each model, a stopping mechanism for the iteration h) a step to compare and rank the models based on their performance on a test dataset i) a step to assign weights to the various models in the ensemble j) given a subject ophthalmic image, a step to compute the weighted-average of the class predictions of the plurality of models, and to choose the ophthalmic image class based on this weighted-averaging step.
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 does 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 performed by a generic computer and no additional features in the claim would preclude them from being performed as such.
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 1-20 are directed to an abstract idea as shown below:
STEP 1: Do the claims fall within one of the statutory categories? YES. Claim(s) 1-20 are directed to a method, and a system performing a method.
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 (or generic computers or components configured to perform the method) (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).
The method in claim 1 comprises a mental process that can be practicably performed in the human mind (or generic computers or components configured to perform the method) and, therefore, an abstract idea.
Regarding claim 1: the method recites the steps (functions) of:
a) an ensemble of machine-learning models each of which consists of: i. a feature extraction mechanism ii. a classification mechanism b) a step to split the input data into training and test sets c) a step to initialize the weights d) for each model, a step in which the feature extraction mechanism yields a feature vector or other object encoding the ophthalmic image features e) for each model, a step in which the feature vector is passed into the classified to yield a class prediction f) for each model, a mechanism to iteratively update the weights to reduce class prediction error g) for each model, a stopping mechanism for the iteration h) a step to compare and rank the models based on their performance on a test dataset i) a step to assign weights to the various models in the ensemble j) given a subject ophthalmic image, a step to compute the weighted-average of the class predictions of the plurality of models, and to choose the ophthalmic image class based on this weighted-averaging step.
All of the steps of claim 1 can be performed by generic computers or components configured to perform the method.
These limitations, as drafted, are a simple process that, under their broadest reasonable interpretation, covers performance of the limitations in the mind or by a human. The Examiner notes that under MPEP 2106.04(a)(2)(III), the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 ("‘[M]ental processes and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193,197 (1978) (same).
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 1 does not recite any of the exemplary considerations that are indicative of an abstract idea having been integrated into a practical application.
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 1 does not recite any additional elements that are not well-understood, routine or conventional. The use of generic computer elements to perform the steps as claimed in Claim 1 is a routine, well-understood and conventional process that is performed by computers.
Independent Claim 14 contains steps that can be performed using a generic computer; therefore, the same rationale pertains.
Thus, since Claims 1-20 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) 1-20 are not eligible subject matter under 35 U.S.C 101.
Allowable Subject Matter
Claims 1-20 would be allowed provided the Double Patenting rejection and the 35USC101 rejection is overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLOTTE M BAKER whose telephone number is (571)272-7459. The examiner can normally be reached Mon - Fri 8:00-5:00.
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/CHARLOTTE M BAKER/Primary Examiner, Art Unit 2664
05 March 2026