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 .
Response to Amendments
The claims were not amended.
Response to Arguments
Applicant's arguments pertaining to the 35 USC § 101 have been fully considered but they are not persuasive. Near the bottom of page 2 of Applicant’s remarks, Applicant argues that:
PNG
media_image1.png
795
1421
media_image1.png
Greyscale
Examiner respectfully disagrees. Throughout the remarks, Applicant provides an explanation for an appropriate interpretation of the claim limitations relative to the specification. The office appreciates this explanation but reminds applicant that claim limitations are given the broadest reasonable interpretation in light of the specification without incorporating limitations not already present in the claims (See MPEP 2106 II C). That is, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, the claim limitations indicated as reciting judicial exceptions are broadly recited such that the full scope of those limitations include mental processes or recited math. In paragraph 37 of Applicant’s specification, Applicant states that, “conducting such studies in a reproducible way may be challenging because manual interpretation of these complex patterns is subject to significant inter-reviewer variability”, which indicates that Applicant is aware that such interpretation is mentally performed by humans. The claim limitations must require the interpretation that Applicant intends and advocates for – relative to the specification.
Beginning in the last paragraph on page 2 of Applicant’s remarks, Applicant argues that:
PNG
media_image2.png
290
1766
media_image2.png
Greyscale
Examiner respectfully disagrees. As broadly recited, Applicant’s excerpt of “identification of a subject for immunotherapy and the classification of CD8 localization” can indeed be reasonably interpreted as being mentally performed by a human observer." This excerpt does not require any interpretation other than a human viewing a display or printed page and mentally performing the identification and classification. Recall that claim limitations are given their broadest reasonably interpretation without incorporating any limitations from the specification that are not present in the claims.
Subsequently, atop page 3, Applicant argues that:
PNG
media_image3.png
688
1723
media_image3.png
Greyscale
Examiner respectfully disagrees. Applicant refers to paragraph 47 from the specification, but this interpretation is not required by the claim. That is, the claim does not require any interpretation of a "applying an artificial neural network (e.g., a convolutional neural network) to the plurality of histology images." Applicant’s argument that, “A human mind cannot practically process the millions of pixels in a high-resolution histology slide to quantify cellular abundance across distinct micro-compartments (parenchyma vs. stroma) with the mathematical precision required. The human mind is "not equipped" to perform the pixel-level segmentation and automated cell counting described in the Specification” is moot because The Office stated that these are additional elements that are generically recited extra-solution activity of data gathering. The Office did not state that these were mental processes.
Subsequently, in the next bullet point in the middle of page 3, Applicant argues that:
PNG
media_image4.png
685
1715
media_image4.png
Greyscale
Examiner respectfully disagrees. These claim limitations explicitly recite a mathematical transformation. Therefore, they are a recite mathematical concept. Mathematical concept abstract ideas include: mathematical relationships, mathematical formulas or equations, or mathematical calculations. A mathematical transformation is a mathematical relationship and mathematical calculation. The specification does not specifically say that the polar coordinate transformation “is a necessary technical step to standardize CD8 topology and eliminate "inter-reviewer variability" that plagues manual human interpretation”. Applicant refers to paragraphs 36 and 43, but these paragraphs do not mention the polar coordinate transformation. Examiner has carefully considered all mentions of “polar coordinate transformation” in the specification and there is no such disclosure. Thus, this is a moot point. Moreover, even if the specification did provide such advantages, the fact remains that the polar coordinate transformation related limitations are recited math, which is a judicial except and cannot incorporate into a practical application or constitute significantly more. Stated more plainly, a judicial exception limitation cannot incorporate itself or another judicial exception limitation into a practical application. Only an additional element, that cannot be interpretation as a judicial element, can incorporate judicial exception limitations into a practical application or constitute significantly more than the judicial element.
In the subsequent bullet point at the bottom of page 3, Applicant argues that:
PNG
media_image5.png
763
1704
media_image5.png
Greyscale
Examiner respectfully disagrees. Again, Applicant refers to details from the specification that are not recited in the claim. The claim does not recite “iteratively fitted in the feature space until the linear
boundaries ... as guided by the patient response data, are optimized.” or “machine learning”, so this is a moot point. Also, Applicants argument that, “The human mind cannot mentally "map" coordinates into an optimized multi-dimensional feature space derived from retrospective clinical data across a plurality of patients” is moot for two reasons. Firstly, The Office stated that the “maps” related limitations are recited math, not mental processes. Secondly, the claim does not recite, “optimized multi-dimensional feature space derived from retrospective clinical data across a plurality of patients”. The claim must require the interpretation that Applicant intends or advocates for.
Atop page 4 of Applicant’s remarks, Applicant argues that:
PNG
media_image6.png
767
1784
media_image6.png
Greyscale
Examiner respectfully disagrees. The claim does not recite or in, any way, require any interpretation of AI. Again, Applicant refers to limitations from the specification, but claim limitations are given the broadest reasonable interpretation in light of the specification without incorporating limitations not already present in the claims (See MPEP 2106 II C). That is, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In the subsequent paragraph on page 3 of Applicant’s remarks, Applicant argues that:
PNG
media_image7.png
600
1780
media_image7.png
Greyscale
Examiner respectfully disagrees. The claim does not recite or in any way require any interpretation of “perform pixel-level neural network analysis or the iterative optimization of linear boundaries in a polar-transformed feature space” (emphasis added). Again, Applicant refers to limitations from the specification, but claim limitations are given the broadest reasonable interpretation in light of the specification without incorporating limitations not already present in the claims (See MPEP 2106 II C). That is, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim limitations are explicitly recited math as is explained in the rejection section below as being “recited math of applying a mathematical model, such as regression, in transforming the result of the polar coordinate transformation into a feature coordinate space with axes of real inflammation and tumor infiltration and calculated lines through the coordinate space marking linear boundaries or linear cutoffs”. The broad claim scope is inclusive of this interpretation.
Subsequently, at the bottom of page 4 of Applicant’s remarks, Applicant argues that:
PNG
media_image8.png
917
1784
media_image8.png
Greyscale
Examiner respectfully disagrees. Additional elements, i.e. limitations that cannot be interpreted as being judicial exceptions, can either individually or in combination incorporate judicial exception limitations into a practical application or constitute significantly more than just the judicial exception(s). However, judicial exception limitations, either individually or in combination, cannot incorporate judicial exception limitations into a practical application or constitute significantly more than just the judicial exception(s). The vast majority of the limitations in the claims are judicial exceptions of mental processes or recited math. The only additional elements present in claim 61, for example, pertain to 1) 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; and 2) generically recited insignificant extra-solution activity of data gathering. According to case law, these additional elements not incorporate judicial exception limitations into a practical application or constitute significantly more than just the judicial exception(s).
Atop page 5 of Applicant’s remarks, Applicant continues to refer to the specification in stating how the claim limitations should be interpreted, but the claims do not require these specific details from the specification:
PNG
media_image9.png
1036
1069
media_image9.png
Greyscale
Examiner respectfully disagrees. As broadly recited in the claim, “receiving a histology image of a sample of the tumor of the subject; performing image analysis on the histology image to obtain image analysis results indicating CD8+ T-cell abundance in tumor parenchyma and stroma in the histology image” are generically recited insignificant extra-solution activity of data gathering. As broadly recited in the claim, “processing a polar coordinate transformation of the image analysis results indicating the CD8+ T-cell abundance in tumor parenchyma and stroma to determine: a real inflammation score of the sample of the tumor; and a tumor infiltration score of the sample of the tumor” is recited math of polar coordinate transformation of coordinates to calculate a real inflammation score and a tumor infiltration score. As broadly recited in the claim, “by applying a patient response model to the polar coordinate transformation of the image analysis results that maps a value of the real inflammation score and a value of the tumor infiltration score in a feature space, the feature space comprising a plot having a first axis and a second axis and defining linear boundaries or linear cutoffs between the plurality of possible classifications of CD8 localization” is recited math of applying a mathematical model, such as regression, in transforming the result of the polar coordinate transformation into a feature coordinate space with axes of real inflammation and tumor infiltration and calculated lines through the coordinate space marking linear boundaries or linear cutoffs. As broadly recited in the claim, “generating a recommendation for a treatment option of the subject based on the classification of the CD8 localization in the sample of the tumor” can be reasonably interpreted as being mentally performed by a human observer visually perceiving relevant plotted data in the feature coordinate space in conjunction with visually perceiving the lines through the coordinate space marking linear boundaries or linear cutoffs.
Beginning at the end of page 5 and extending to page 6, Applicant argues that:
PNG
media_image10.png
887
1068
media_image10.png
Greyscale
Examiner respectfully disagrees. The image analysis is generically recited insignificant pre-solution activity of data gathering. That is, there is no disclosure of any particular problem that the image analysis specifically solves. Indeed, the “image analysis” is quite generically recited because “image analysis” is a very broad genus inclusive of many textbooks and code libraries of worth of different algorithms. The claim does not require any interpretation of AI, or neural network, or CNN – as Applicant argues. The image analysis is pre-solution data gathering because it merely gathers and provides the CD8+ T-cell abundance information to be passed on to the actual aspects of the invention that are disclosed to be solutions to problems or improvements over the prior art. Again, there is no disclosure of, specifically, the “image processing” being a solution to a particular problem or improvement over existing technology. As stated earlier, the claimed polar coordinate transformation is a recited math abstract idea. The Office never said that the polar coordinate transformation is a mental process or a generic computer component. These limitations are itemized very carefully in the 35 USC 101 rejection section below.
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 61-84 are rejected under 35 U.S.C. 101 because the claimed invention is directed to recited math and mental process abstract ideas without significantly more.
Claim(s) 61 recite(s):
“method for identifying a subject suitable for immunotherapy to treat a tumor of the subject”, which can be reasonably interpreted as being mentally performed by a human observer considering relevant data.
“processing a polar coordinate transformation of the image analysis results indicating the CD8+ T-cell abundance in tumor parenchyma and stroma to determine: a real inflammation score of the sample of the tumor; and a tumor infiltration score of the sample of the tumor”, which is recited math of polar coordinate transformation of coordinates to calculate a real inflammation score and a tumor infiltration score;
“determining, from a plurality of possible classifications of CD8 localization, a classification of CD8 localization in the sample of the tumor”, which can be reasonably interpreted as being mentally performed by a human observer visually perceiving relevant plotted data;
“by applying a patient response model to the polar coordinate transformation of the image analysis results that maps a value of the real inflammation score and a value of the tumor infiltration score in a feature space, the feature space comprising a plot having a first axis and a second axis and defining linear boundaries or linear cutoffs between the plurality of possible classifications of CD8 localization”, which is recited math of applying a mathematical model, such as regression, in transforming the result of the polar coordinate transformation into a feature coordinate space with axes of real inflammation and tumor infiltration and calculated lines through the coordinate space marking linear boundaries or linear cutoffs; and
“generating a recommendation for a treatment option of the subject based on the classification of the CD8 localization in the sample of the tumor”, which can be reasonably interpreted as being mentally performed by a human observer visually perceiving relevant plotted data in the feature coordinate space in conjunction with visually perceiving the lines through the coordinate space marking linear boundaries or linear cutoffs.
This judicial exception is not integrated into a practical application because additional elements of:
“A computer-implemented method… the method executing on data processing hardware that causes the data processing hardware to perform operations comprising” 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
“receiving a histology image of a sample of the tumor of the subject; performing image analysis on the histology image to obtain image analysis results indicating CD8+ T-cell abundance in tumor parenchyma and stroma in the histology image” are generically recited insignificant extra-solution activity of data gathering.
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 computer-implemented method… the method executing on data processing hardware that causes the data processing hardware to perform operations comprising” 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); and
“receiving a histology image of a sample of the tumor of the subject; performing image analysis on the histology image to obtain image analysis results indicating CD8+ T-cell abundance in tumor parenchyma and stroma in the histology image” are insignificant extra-solution activity of data gathering.
Depending claims 62-72 do not remedy these deficiencies:
Claims 62-65 further recite limitations pertaining to mental process abstract idea of a human observer visually perceiving relevant plotted data in the feature coordinate space in conjunction with visually perceiving the lines through the coordinate space marking linear boundaries or linear cutoffs.
Claims 66, 69, and70 further recite limitations pertaining to recited math abstract ideas and insignificant extra-solution activity of data outputting additional elements.
Claims 67 and 72 further recite limitations pertaining to recited math abstract ideas.
Claim 68 further recites limitations pertaining to recited math abstract ideas and insignificant extra-solution activity of data gathering additional elements.
Claim 71 further recites limitations pertaining to insignificant extra-solution activity of data gathering additional elements.
As per claim(s) 73-84, arguments made in rejecting claim(s) 61-72 are analogous, respectively. Claims 73-84 further recite, “A system comprising: data processing hardware; and memory hardware in communication with the data processing hardware and storing instructions that when executed on the data processing hardware causes the data processing hardware to perform operations”, which are additional elements that area 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 61-84 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is US 20210098082 A1 (Udyavar). Limitations pertaining to “determining, from a plurality of possible classifications of CD8 localization, a classification of CD8 localization in the sample of the tumor by applying a patient response model to the polar coordinate transformation of the image analysis results that maps a value of the real inflammation score and a value of the tumor infiltration score in a feature space, the feature space comprising a plot having a first axis and a second axis and defining linear boundaries or linear cutoffs between the plurality of possible classifications of CD8 localization”, in conjunction with other limitations present in the independent claim(s), distinguish over the prior art.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
Prosecution Insights