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
Claim 5 is objected to because of the following informalities: Claim 5 ends in a comma instead of a period. Each claim must be a single, complete sentence. 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.
Claims 4-6 and 14-16 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.
Claims 4, 5, 14, and 15 recite the limitation "the growth rate". There is insufficient antecedent basis for this limitation in the claim. One of ordinary skill in the art cannot know which growth rate is being referred to.
Depending claims 6 and 16 do not remedy these deficiencies.
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 20 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 the limitations, “a computer readable storage medium storing instructions” can be reasonably interpreted as a transitory signal storing instructions while propagating. These limitations do not require the interpretation that the “computer readable storage medium” is non-transitory.
Claims 1-4, 8-14, and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to mental process abstract idea without significantly more.
Claim(s) 1 recite(s):
“A system for diagnostic image analysis of a target object that is inside a subject”, which can reasonably be interpreted as a human observer viewing a displayed image and mentally performing diagnostic analysis via visual perception;
“generate, based on the binary image, a size estimate of the target object”, which can reasonably be interpreted as a human observer viewing a displayed binary image and mentally generating a size estimate of the target object via visual perception.
“uses the size estimate and one or more covariates to predict a future size of the target object”, which can reasonably be interpreted as a human observer mentally predicting a future size of the target object based on a mental assessment of the mentally determined size estimate and mentally assessed one or more covariates – via simple math implemented with the aid of pen and paper;
“determine a risk classification for the subject based on the predicted future size, the risk classification being based on a probability that the target object of the subject will result in a disease state, the risk classification (the following is recited as intended use and is not required) to be used to determine a treatment regimen to (the following are listed as alternatives – in addition to be part of the intended use recitation) treat or prevent the disease state”, which can reasonably be interpreted as a human observer mentally determine a risk classification based on the mentally predicted future size based on a mentally determined probability that the target object will result in a disease state. The risk determination and probability determination can be performed mentally via simple math and the aid of pen and paper. A treatment regimen can be mentally determined based on the mentally determined risk
This judicial exception is not integrated into a practical application because additional elements of:
“a processor programmed to” are generically recited computer elements that do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer;
“access a source image of the subject” are generically recited insignificant extra-solution activity of data gathering;
“execute an image segmentation model that uses the source image to distinguish the target object from among other objects in the source image” are generically recited;
“generate a binary image of the target object based on execution of the image segmentation model” are generically recited;
“execute a machine learning-based model” are generically recited.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because additional elements of:
“a processor programmed to” are mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f);
“access a source image of the subject” are insignificant extra-solution activity of data gathering;
“execute an image segmentation model that uses the source image to distinguish the target object from among other objects in the source image” are well-understood, routine, conventional;
“generate a binary image of the target object based on execution of the image segmentation model” are well-understood, routine, conventional;
“execute a machine learning-based model” are well-understood, routine, conventional.
Depending claims do not remedy these deficiencies:
Claims 2, 9, and 10 further recite limitations that pertain to generically recited insignificant extra-solution activity of data gathering.
Claim 3 further recites limitations that are reasonably interpreted as mental process abstract idea(s). Claim 3 also further recites limitations that pertain to “the machine learning-based model” that are generically recited and well-understood, routine, conventional.
Claim 4 further recites limitations that are reasonably interpreted as mental process abstract idea(s). Claim 4 also further recites limitations that pertain to generically recited insignificant extra-solution activity of data gathering. Claim 4 also further recites limitations that pertain to “the machine learning-based model” that are generically recited and well-understood, routine, conventional.
Claim 8 further recites limitations that are reasonably interpreted as mental process abstract idea(s).
As per claim(s) 11-14 and 18-19, arguments made in rejecting claim(s) 1-4 and 8-9 are analogous, respectively. Claim 11 also recites limitations, “by a processor”, which are generically recited computer elements that do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer and are mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As per claim(s) 20, arguments made in rejecting claim(s) 1 are analogous. Claim 20 further recites, “a computer readable storage medium storing instructions for diagnostic image analysis of a target object that is inside a subject, the instructions when executed by a processor, causes the processor to”, which are generically recited computer elements that do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer and are mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
Allowable Subject Matter
Claims 1-4, 8-14, and 18-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
Claims 4-6 and 14-16 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 7 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Limitations pertaining to “generate, based on the binary image, a size estimate of the target object;
execute a machine learning-based model that uses the size estimate and one or more covariates to predict a future size of the target object; and determine a risk classification for the subject based on the predicted future size, the risk classification being based on a probability that the target object of the subject will result in a disease state, the risk classification to be used to determine a treatment regimen to treat or prevent the disease state”, in conjunction with other limitations present in the independent claim(s) 1, 11, and 20, distinguish over the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Atiba Fitzpatrick whose telephone number is (571) 270-5255. The examiner can normally be reached on M-F 10:00am-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Bee can be reached on (571) 270-5183. The fax phone number for Atiba Fitzpatrick is (571) 270-6255.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Atiba Fitzpatrick
/ATIBA O FITZPATRICK/
Primary Examiner, Art Unit 2677