DETAILED ACTION
Applicant's response, filed 8/27/2025, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 filed 10/12/2020 is a National Stage entry of PCT/EP2019/059451, with an International Filing Date of 04/12/2019, and claims foreign priority to UK application 1806064.0, filed 04/12/2018. The claims are therefore examined as filed on 04/12/2018, the effective filing date. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further review of the priority application(s).
Claim Status
Claims 1-2, 5, 10-17, 19-23, 27-28, and 30 are pending.
Claims 3-4, 6-9, 18, 24-26, 29, 31-42 are cancelled.
Claims 1-2, 5, 10-17, 19-23, 27-28, and 30 are examined.
Claims 1-2, 5, 10-17, 19-23, 27-28, and 30 are rejected.
Withdrawn Rejections
The rejection of claim 30 under 35 U.S.C. §112(a), in the Office action mailed 03/03/2025 is withdrawn in view of the amendments filed 8/27/2025.
The rejection of claim 30 under 35 U.S.C. §112(b), in the Office action mailed 03/03/2025 is withdrawn in view of the amendments filed 8/27/2025.
The rejection of claims 1-2, 5, 13-14, 16, 19, 21-23 and 30 under 35 U.S.C. §103 over OLMOS in view of MARTOGLIO, in the Office action mailed 03/03/2025 is withdrawn in view of the amendments filed 8/27/2025, and persuasive argument that the combined references do not teach the amended limitation of using the expression status of, specifically, at least 100 of the genes listed in the claim, to provide a patient expression profile for classifying prostate cancer (remarks pg 20).
The rejection of claims 10-12 under 35 U.S.C. §103 over OLMOS in view of MARTOGLIO and ROGERS, in the Office action mailed 03/03/2025 is withdrawn in view of the amendments filed 8/27/2025, and withdrawal of the rejection of claims 1-2, 5, 13-14, 16, 19, 21-23 and 30 above.
The rejection of claim 15 under 35 U.S.C. §103 over OLMOS in view of MARTOGLIO and DE KOK, in the Office action mailed 03/03/2025 is withdrawn in view of the amendments filed 8/27/2025, and withdrawal of the rejection of claims 1-2, 5, 13-14, 16, 19, 21-23 and 30 above.
The rejection of claim 17 under 35 U.S.C. §103 over OLMOS in view of MARTOGLIO and LI, in the Office action mailed 03/03/2025 is withdrawn in view of the amendments filed 8/27/2025, and withdrawal of the rejection of claims 1-2, 5, 13-14, 16, 19, 21-23 and 30 above.
The rejection of claim 20 under 35 U.S.C. §103 over OLMOS in view of MARTOGLIO and D’ANTONIO, in the Office action mailed 03/03/2025 is withdrawn in view of the amendments filed 8/27/2025, and withdrawal of the rejection of claims 1-2, 5, 13-14, 16, 19, 21-23 and 30 above.
The rejection of claims 27-28 under 35 U.S.C. §103 over OLMOS in view of MARTOGLIO and SHIN, in the Office action mailed 03/03/2025 is withdrawn in view of the amendments filed 8/27/2025, and withdrawal of the rejection of claims 1-2, 5, 13-14, 16, 19, 21-23 and 30 above.
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 1-2, 5, 10-17, 19-23, 27-28, and 30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of mental processes and mathematical concepts, without significantly more.
The MPEP at MPEP 2106 sets forth steps for identifying eligible subject matter:
(1) Are the claims directed to a process, machine, manufacture or composition of matter?
(2A)(1) Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea?
(2A)(2) Do the claims recite additional elements that integrate the judicial exception into a practical application?
(2B) If the claims recite a judicial exception and do not integrate the judicial exception, do the claims recite additional elements that provide an inventive concept and amount to significantly more than the judicial exception?
With regard to step (1) (Are the claims directed to a process, machine, manufacture or composition of matter?): Yes. The claims are directed to one of the statutory classes. Claims 1-2, 5, 10-17, 19-23, and 27-28 are directed to a process (a method of classifying prostate cancer). Claim 30 is directed to a product (a non-transitory computer readable medium).
With regard to step (2A)(1) (Do the claims recite a judicially recognized exception?): Yes. The claims recite the abstract ideas of processing data using mental steps and mathematical concepts. Claims that recite nothing more than abstract ideas, natural phenomena, or laws of nature are not eligible for patent protection (see MPEP 2106.04).
Abstract ideas include mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations), certain methods of organizing human activity, and mental processes (including procedures for collecting, observing, evaluating, and organizing information (See MPEP 2106.04(a)(2)). In particular, these abstract ideas include but are not limited to:
Classifying prostate cancer or progression by determining the contribution of cancer expression signatures to the patient expression profile (mental process/mathematical concept; the human mind is capable of making a classification based on data, and the classification process is an algorithm based on latent process decomposition, a machine learning model composed of mathematical functions (pg 3 of the specification); claims 1, 2, 30)
Assigning the patient cancer to a cancer classification (mental process; the human mind is capable of assigning a classification based on data; claim 2)
Splitting the patient expression profile between the gene expression profile for each cancer expression signature (mental process; the human mind is capable of organizing data; claim 14)
Normalizing the patient expression profile to the profiles of the reference dataset (mental process/mathematical concept; the human mind is capable of normalizing data, and normalizing data is equivalent to performing a calculation/using math; claim 15)
Dependent claims 5, 10-17, 19-23, and 27-28 further limit the abstract ideas in the independent claims, and do not change their characterization as abstract ideas.
Therefore, the claims recite elements that constitute one or more judicial exceptions.
With regard to step (2A)(2) (Do the claims recite additional elements that integrate the judicial exception into a practical application?): No. Claims 1-2, 5, 10-17, 19-23, and 27-28 recite the additional element of obtaining reference parameters from an LPD analysis, and obtaining or providing the expression status of genes in a sample obtained from a patient. Claim 30 further recites the additional element of “a non-transitory computer readable medium programmed to perform a method according to claim 1”.
While claim 1 and its dependents recite the additional element of acquiring data (obtaining reference parameters and expression status from patients), a data gathering step without any further description of how the data is obtained/output is an insignificant extra-solution activity that does not add a meaningful limitation to the claims (see MPEP 2106.05(g)). As a result, the judicial exception is not integrated into a practical application. In addition, while claim 30 recites additional elements related to the use of computers, it does not provide any specific details by which the computer readable medium performs or carries out the judicial exception listed in step (2A)(1), nor does it provide any details of how specific structures of the computer are used to implement these functions. The judicial exception is therefore not integrated into a practical application because the generically recited computer element does not add a meaningful limitation to the abstract idea (see MPEP 2106.05(f)).
With regard to step (2B) (Do the claims recite additional elements that provide an inventive concept and amount to significantly more than the judicial exception?): No. The claims recite an abstract idea with additional elements; however, these additional elements are general computer elements added to abstract ideas, and non-particular instructions to apply the abstract idea by linking it to a field of use or extrasolution activity (see MPEP 2106.05(f-h)). General computer elements used to perform an abstract idea do not provide an inventive concept, and similarly, non-particular instructions to gather or provide data, do not provide an inventive concept. In particular, obtaining expression status information and analyzing it using an LPD analysis is a known technique, and considered well-understood, routine and conventional (see ROGERS 2005 as previously cited). The claims therefore do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As a result, the claims as a whole do not provide an inventive concept.
Response to Arguments – Rejections Under 35 USC § 101
In the reply filed 8/27/2025, Applicant asserts that the claims are not directed to a judicial exception because claim 1 includes the step of obtaining or providing the expression status of genes in a sample obtained from a patient, and is thus a clinical application of a method (remarks pg 17-18). However, while obtaining or providing expression status is considered an additional element, it does not negate the fact that the other limitations of claim 1 are directed to judicial exceptions. Further, the step of obtaining/providing data does not integrate the judicial exception because it is a necessary data gathering step, and the fact that obtaining the data may be related to clinical use does not remedy this. The MPEP 2106.05(g)
provides examples of what the courts have found to be an insignificant extra-solution activity: limitations of “Performing clinical tests on individuals to obtain input for an equation”, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989) and “Determining the level of a biomarker in blood”, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis) for example, are extrasolution activities. Even though they are “clinical” additional elements, they, like the instant claims, serve only to provide data for judicial exceptions.
The Applicant also asserts that the claims recite additional features that amount to significantly more than the judicial exception because they provide a novel and clinically relevant method of classification of prostate cancer that translates into a treatment plan based on the analysis (remarks pg 18). However, the classification of the claims is not an additional element, it is part of the judicial exception not “significantly more.” There is also currently no treatment step in the claims than can amount to significantly more. A treatment step, if added, could potentially integrate the claims into a practical application, but it would need to be a clear, active step that recites administering a particular treatment for a medical condition determined by the judicial exception (see MPEP 2106.04(d)(2)), and not contingent on other steps. Further, this would only fix the method claims, as the computer readable medium of claim 30 is unable to perform a step of administering a treatment without any structure/hardware to enable it to do so.
Currently, however, the claims do not recite additional elements that integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY C LEVERETT whose telephone number is (571)272-5494. The examiner can normally be reached 8:00am - 5:00pm M-Th.
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/M.C.L./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687