DETAILED ACTION
Applicant's response, filed 04/17/2026, 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.
Claim 1 is objected to.
Claims 1-2, 5, 10-17, 19-23, and 27-28 are allowed.
Claim 30 is rejected.
Withdrawn Rejections
The rejection of claims 1-2, 5, 10-17, 19-23, 27-28 under 35 U.S.C. §101 in the Office action mailed 11/17/2025 is withdrawn in view of the amendments filed 4/17/2026, as these claims now recite the additional element of administering a particular treatment for cancer, which constitutes a particular treatment for a medical condition and therefore integrates the abstract ideas of the claims into a practical application.
Claim Objections
Claim 1 is objected to because of the following informalities:
Step d) of claim 1 should read “administering to the subject a treatment for cancer based on the classification or prediction of prostate cancer in step [[b]]c…” as step c is the classifying step, not step b.
Appropriate correction is required.
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 30 is 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. 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. Claim 30 recites 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); claim 30)
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. Claim 30 recites the additional element of “a non-transitory computer readable medium programmed to perform a method according to claim 1 steps a-c”, which further includes the additional elements of obtaining reference parameters from an LPD analysis, and obtaining or providing the expression status of genes in a sample obtained from a patient.
While this claim includes 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
Regarding the remarks filed 04-17-26, the Applicant has stated that the “Examiner contends that claim 30 is not directed to one of the statutory classes” To clarify, this was not the position of the Examiner in the previous office action, as the previous action stated that “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).”
The reason why claim 30 was previously rejected, and why it is currently rejected, is because it does not contain an additional element that integrates the judicial exception. In comparison, claim 1 and its dependents, as amended, do now contain an additional element that integrates (the treatment step) and are therefore allowable. Because claim 30 explicitly does not contain this treatment step, or another additional element that integrates, it remains rejected under 101.
As previously discussed, however, claim 30 is directed towards a non-transitory computer-readable medium, which cannot perform such a treatment step without invoking 35 U.S.C. §112(a) or 35 U.S.C. §112(b) (as in the office action filed 03/03/2025). As such, the Examiner recommends that claim 30 be cancelled so allowance of the other claims can proceed.
Conclusion
Claims 1-2, 5, 10-17, 19-23, and 27-28 are allowed.
Claim 30 is rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/M.C.L./ Examiner, Art Unit 1687
/OLIVIA M. WISE/ Supervisory Patent Examiner, Art Unit 1685
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