FINAL ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is responsive to the Amendments and Response filed 05 May 2026. Claims 1, 3-6, 8, and 10-13 have been amended, claims 2, 7, and 9 have been canceled, and claim 17 has been added. All prior rejections of claims 2, 7, and 9 are moot in view of the cancelation of those claims. Claims 1, 3-6, 8, 10-13, and 17 are now under consideration. Applicant’s amendments and arguments have been thoroughly reviewed, and have overcome the following objections/rejections set forth in the prior Office action:
The objection to the specification, in view of Applicant’s corrective amendments (although Applicant’s attention is directed to the comment below);
The objection to claim 10, in view of Applicant’s amendment of the claim; and
Several rejections of claims under 35 USC 112(b)/second paragraph in view of Applicant’s claim amendments (although it is noted that the amended claims remain indefinite for the reasons given below).
Claims 1, 3-6, 8, 10-13, and 17 remain/are rejected for the reasons given below, which include new grounds of rejection necessitated by Applicant’s amendments. Any rejections and/or objections not reiterated in this action have been withdrawn. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 23 December 2025 is again acknowledged.
Applicant’s election of the species of “(i) determining the level; (ii) first biomarker: METTL3; (iii) second biomarker: combination of CTU1, CTU2, MOCS3, and URM1; and (iv) disease: cancer (and if necessary….breast cancer)” in the reply filed on 23 December 2025 is also again acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
It is also reiterated that the prior art was not found to apply against the elected “second biomarker” combination of CTU1, CTU2, MOCS3, and URM1 (resulting in claim 10 having been found to be free of the prior art, although the claim remains rejected on other grounds). Search and examination was thus extended to “at least one” of CTU1, CTU2, MOCS3, and URM1, and it is noted that independent claims 1 and 8 now recite “at least one second biomarker” that “is selected from” this group (such that all claims continue to embrace any of these second biomarkers alone or in combination, with only dependent claim 10 being limited to “a panel of CTU1, CTU2, MOCS3, and URM1”.
Comment Regarding Specification Amendments
While it is noted that Applicant’s amendments of 05 May 2026 have overcome the objection to the specification related to hyperlinks, Applicant is reminded that the objection could have been overcome by simply modifying references to websites so as to limit them to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
Regarding the language “selecting….a treatment” (see new step e) of claim 1), it is noted that the specification does not define what is encompassed by this terminology, but does disclose activities corresponding to mentally “selecting” a treatment, such as making decisions regarding treatment (e.g., “deciding in favor or against” a treatment or “deciding” on a type of treatment; see, e.g., paragraphs 103, 113, 115), and “stratifying a patient for” a treatment or type of treatment (see, e.g., paragraphs 111-114). Accordingly, the term “selecting” has been interpreted as encompassing mental “selection” of a course of treatment (which may include deciding in favor of or against treatment, a type or course of treatment to pursue, etc.).
Claim Rejections - 35 USC § 112(b)/second paragraph
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claims 1, 3-6, 10, 13, and 17 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 1, 3-6, 10, 13, and 17 are indefinite over the recitation in amended claim 1 of the limitation “(e) Selecting or administering a treatment to said subject based on said differential level, mutation status, and/or activity..”. First, the claim as amended recites two alternative “wherein” clauses that reference “a differential level, mutation status, and/or activity” which – given the fact that these further limitations are separated by “or” and thus clearly alternatives to one another – may encompass different types of “differential” level/status/activity. Accordingly, there is more than one “differential level, mutation status, and/or activity” previously recited in the claim, and clear antecedent basis is therefore lacking for the limitation. Second, while it is noted that the “selecting or administering” is clearly a conditional/contingent step (given that the claim as written does not require that the “comparing” result in a finding that a “differential” level/status/activity is present), to the extent that this further activity may be required, it is not clear: a) what is encompassed by the language “based on said differential level, mutation status, and/or activity”, i.e., what types of “selecting or administering” activities would be considered as “based on” such criteria, and what types would not (as neither the guidance in the specification nor the claims themselves make this clear); and b) whether in the case that some type of “differential” level/status/activity is present, the claim language does or does not embrace “selecting or administering” no treatment (given that the specification discloses, e.g., deciding not to treat a subject). Further clarification is therefore required.
Claim 6 is indefinite because it is unclear how the claim further limits claim 1, from which it depends. As discussed above, there are two alternative types of “differential level, mutation status, and/or activity” referenced in independent claim 1. Thus, while it appears that claim 6 may be intended to simply limit the claims to the outcome of the first recited “wherein” clause, the present claim language does not make this sufficiently clear (given that there are multiple ways in which “the differential level, mutation status, and/or activity” might pertain to claim 1. Further, given this lack of clarity, it is also unclear whether the “wherein” clause further limiting of “said reference sample or reference value” only pertains to the alternative referenced previously in claim 6, or whether this a separate/distinct limitation that applies to all possible alternatives embraced by the claims. Further clarification is therefore needed.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claim(s) 1, 3-6, 8, 11-13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al (BMC Cancer 19:326 [April 2019]; cited in IDS) in view of Delaunay et al (Nature Cell Biology 21:552-559 [May 2019]; cited in IDS).
Wu et al teach methods in which expression levels of m6A methylases, including the elected biomarker METTL3, were determined in 36 pairs of breast cancer tissues and adjacent non-cancerous tissue (see entire reference, particularly the Abstract; page 2, “Patients”; page 3, right column, “Quantitative RT-PCR (qRT-PCR)”; Results at pages 4-6, particularly page 5, right column bridging to page 6, left column; and Fig. 5). With more particular regard to the methods steps of independent claims 1 and 8, Wu et al teach providing biological samples from subjects/patients by collecting “samples of fresh BC cancerous tissues and paired normal tissues” (see again page 2, “Patients), and teach determining and comparing expression levels of METTL3 and other m6A biomarkers in both the cancerous and normal tissues (see again page 3, right column); Wu et al thus teach methods including a “providing” meeting the requirements of a) of the claims, a “determining” meeting the requirements of b) of the claims with regard to the elected species of METTL3, and a “comparing” meeting the requirements of d) of the claims with respect to a “first” biomarker.
With further regard to the preamble and “wherein” clauses of claim 1, it is also noted that:
a) the method of Wu et al constitutes at least a type of “monitoring” of breast cancer, such that the intended use of the preamble of claim 1 is achieved by Wu et al;
b) the “wherein” clauses recited at the end of claim 1 state what is indicated by possible – but not required - outcomes of the claimed methods that pertain to levels of “said at least one first biomarker” (as well “at least one second biomarker”), such that claim scope is not limited by this claim language (see MPEP 2111.04). However, while not required to meet the claims, it is also noted that Wu et al do in fact teach that “expression of m6A members including METTL3” was tightly associated with cancer progression and poor survival” (see the Abstract; see also page 5, right column-page 6, left column; Fig. 5) (such that Wu et al do teach a “differential level” of a “first biomarker” that is associated with progression and poor survival, although this teaching is not required to meet the claim).
With further regard to independent claim 8, the teachings of Wu et al set forth above also meet the requirements of the “identifying a differential level” recited in independent claim 8 at lines 2-3 with regard to the “at least one first biomarker” of METTL3. Additionally, with regard to the intended use of “stratifying a patient for treatment” and the recitation of “deciding in favor of or against said treatment based on said differential level…”, the claim never sets forth any required active steps of treating/treatment/administering or equivalent actions, but rather recites “stratifying” and “deciding in favor of or against” a treatment; such limitations constitutes instructional limitations, i.e., nonfunctional descriptive material that need not be given patentable weight when comparing a claimed invention to the prior art (see MPEP 2111.05). Furthermore, the claims set forth no particular requirements with regard to what “identifying a differential level” requires; rather, the claim states that such an “identifying” is achieved by performing the “providing”, “determining”, and “comparing” of (a)-(d) of claim 8, for which no particular outcome is specified. Additionally, the newly added “administering” of the claim, which recites “administering….when it is decided in favor of treatment”, is clearly a conditional/contingent (rather than a required) step (such that claim scope is not limited by this language; see again MPEP 2111.04). Thus, performance of steps of (a)-(d) of claim 8 is all that is required to meet the claims (with the “comparing” of d) also being an instructional step requiring nothing more than thinking about the results of prior steps, although it is reiterated that Wu et al do disclose such a “comparing” with regard to m6A biomarkers inclusive of METTL3).
Wu et al do not teach determining levels of “at least one second biomarker” of the mcm5s2U-tRNA pathway, particularly including any of the second biomarkers CTU1, CTU2, MOCS2, and URM1, and thus do not teach methods meeting all requirements of the claims.
Delauney et al teach that “altered RNA modification patterns are widely linked to developmental diseases”, and that RNA modifications are also contributors to cancer (see entire reference, particularly the Abstract). Delauney et al provide an overview of how different types of RNA modifications contribute to cancer, describing the role of both the m6A pathway (which is taught as requiring METTL3) and the mcm5s2U pathway; see entire reference including Figures 1 and 2; page 552, right column, second paragraph; page 553, right column, first full paragraph; and the entirety of page 554-556, noting that both pathways are disclosed as being implicated in breast cancer (see, e.g., page 556, left column, 4th full paragraph regarding upregulation of mcm5s2U genes in breast cancer), and that all of METTL3, CTU1, and CTU2 are disclosed/depicted in, e.g., Figures 1-2. With further regard to claim 8 and claims dependent therefrom, while it is reiterated that the elements of the claims related to “treatment” constitute non-functional descriptive material, Delauney et al also teach that “recent studies have demonstrated a link between RNA modifications and tumour cell survival in response to chemotherapy, and state that “modulation or inhibition of RNA modification pathways offers therapeutic strategies to target specific tumor populations” (page 556, right column), providing motivation to analyze and consider both m6A and mcm5s2U pathway members in relation to drug resistance (including chemotherapy resistance) and treatment selection.
In view of the teachings of Delauney et al, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods of Wu et al so as to have included therein additional steps of determining levels of one or more biomarkers of the mcm5s2U pathway, including specific biomarkers such as CTU1 and CTU2. As Delauney et al teach that both the m6A and mcm5s2U pathways have been implicated in cancer, including breast cancer, an ordinary artisan would have been motivated to have made such a modification simply for the benefit of determining additional relevant biomarkers exhibiting altered expression in association with breast cancer, achieving a more comprehensive “monitoring” of the cancer as compared to Wu et al alone. Additionally, as Wu et al state that their goal in performing their analysis of m6A methylases and demethylases was to aid in “understand the pathogenic molecular mechanisms of m6A and for diagnosis” (page 2, left column, last full paragraph), an ordinary artisan would also have been motivated to have performed analogous measurements/determinations regarding mcm5s2U markers for these same benefits (and it is reiterated that the claims as presently written do not require a particular outcome of the “determining” and “comparing” steps of the claims, such that only performance of the recited steps noted above is required to meet the claims). Furthermore, given Delauney et al’s teachings of the relevance of both the m6A and mcm5s2U pathways to drug resistance (including chemotherapy resistance in cancer), an ordinary artisan also would have been motivated to have made such a modification for the benefit of identifying any altered expression levels in either pathway that could aid in better selection of treatment/therapy for a patient. Finally, given the guidance provided by Wu et al and Delauney et al, and particularly the identification by Delauney et al of specific markers that are suitable targets for such analysis, an ordinary artisan would have had a reasonable expectation of success in performing such methods.
Regarding claim 3, Wu et al in view of Delauney et al teach at least the preferred embodiments of cancer, including breast cancer.
Regarding claim 4, Wu et al teach tissue samples (including breast cancer tissues and paired normal tissues), as discussed above (see again page 2, “Patients”).
Regarding claim 5, Wu et al teach qRT-PCR of RNA, which encompasses “mRNA analysis” (see page 3, right column, first full paragraph).
Dependent claim 6 recite what is indicated by a possible outcome of the performance of the active method steps of the claims, without actually requiring the stated outcomes. “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met” (MPEP 2111.04(II)). Thus, claim 6 is suggested by Wu et al in view of Delauney et al for the same reasons given above regarding claim 1.
Claim 11 recites “deciding in favor of” a treatment “based on” a “differential level” that is not required by the claims. Again, the BRI of such a claim requires only those steps that must be performed. Further, the act of “deciding” is an instructional limitation, i.e., nonfunctional descriptive material that need not be given patentable weight when comparing a claimed invention to the prior art (see MPEP 2111.05).
Claim 12 is a further limitation of “said treatment”, but as already noted, claim 8 does not require a treatment (such that the claim is rejected on the same grounds that apply to claim 8).
Dependent claim 13 requires that “the method is a non-invasive method, and the testing of tissue samples disclosed by Wu et al is performed ex vivo (which meets the requirements of the claim).
Regarding dependent claim 17, this claim is further limiting of “said treatment” of claim 1; however, no treatment is required by the language of claim 1 (such that the claim is rejected on the same grounds that apply to claim 1).
The reply of 05 May 2026 traverses the prior rejection of claims under 35 USC 103 on the following grounds.
Applicant notes that “Wu does not teach or suggest determining levels of at least one second biomarker” as recited in the claims, and that the independent claims have been amended to clarify that the claimed methods require determining both the “at least one first biomarker” and the “at least one second biomarker” (Reply page 11). Next, Applicant argues that neither Wu nor Delauney “alone or in combination, teach or suggest this dual-pathway biomarker analysis”, and further that these references “fail to provide any motivation to combine these distinct biological pathways for diagnostic or prognostic purposes”, urging that the claims “provide a discovery of a previously unrecognized functional interdependency between m6A-mediated mRNA modification and mcm5s2U-mediated tRNA modification” (Reply page 11 bridging to page 12). Furthermore, Applicant argues that the non-obviousness of the claims is supported by unexpected results exemplified in the specification, particularly related to “a previously unknown link…identified between the mRNA and tRNA epitranscriptomes”, “the co-occurrence of somatic mutations in m6A and mcm5s2U biogenesis factors”, differences in “m6A and mcm5s2U biogenesis signatures” in normal tissue as compared to tumors, “correlation between combined m6A/mcm5s2U signatures and patient prognosis”, and correlation of “combined biomarker signature” with treatment sensitivity (Reply page 13).
These arguments have been thoroughly considered but are not persuasive.
First, with regard to Wu et al’s failure to teach a second biomarker as recited in the claims, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Second, it is reiterated that (as discussed in the rejection itself) the Delauney et al reference provides an overview of how different types of RNA modifications contribute to cancer, describing the role of both the m6A pathway and the mcm5s2U pathway and teaching that both pathways have been implicated in breast cancer (with Delauney et al also disclosing all of METTL3, CTU1, and CTU2, i.e., biomarkers corresponding to the elected species under consideration). Thus, the teachings of the cited art are clearly sufficient to suggest all required limitations of the present claims. Further, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Third, and with particular regard to Applicant’s assertions of unexpected results, the claims under consideration simply require determining and comparing the required first and second biomarker levels (with the elected species as recited in the rejected claims corresponding to METTL3, any of CTU1/CTU2/MOCSW3/URM1, and cancer/breast cancer; it is particularly reiterated that Applicant’s claim limited to the specific group of claim 10 was in fact excluded from the rejection). The claims under consideration do not require detection of the referenced specific signatures or relative levels thereof, mutation detection, etc., as referenced in Applicant’s arguments. 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). Further, in order for unexpected results to be relied upon as objective evidence of nonobviousness, those results must be commensurate in scope with the claims (see MPEP 716.02(d)). Accordingly, these arguments are not found persuasive with regard to rejected claims 1, 3-6, 8, 11-13, and 17.
Claim Rejections - 35 USC § 101
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claims 1, 3-6, 8, 10-13, and 17 remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea and a natural phenomenon/law of nature without significantly more.
Independent claim 1 (from which claims 2-6, 10, 13, and 17 depend) is drawn to a method “for the prognosis, diagnosis, and/or monitoring of a disease, condition or disorder in a subject”, and recites “comparing the determined level, mutation status, and/or activity” of at least one first and at least one second biomarkers (as recited in steps (b) and (c)) with a reference sample or a reference value, wherein a differential level, mutation status, and/or activity of said first and second biomarker in the sample as compared to said reference sample or value “is indicative for” either progression free survival [PFS] and/or overall survival [OS] or “for the presence of” the disease, condition or disorder. Such a “comparing” requires nothing more that reviewing and mentally comparing the results of the prior steps of “determining” with a reference sample or value (i.e., another type of information), which is an activity that may be performed entirely in the human mind, i.e., an abstract idea. Claim 1 has also been amended to add the limitation “Selecting or administering a treatment”, and it is noted that (while this language is conditional rather than required, as noted below), the “selecting” of the claim embraces further activities that may be conducted entirely in the human mind (e.g., by decided whether to treat, what treatment to “select”, etc.), i.e., a further abstract idea.
Independent claim 8 (from which claims 11-12 depend) is drawn to a method “of stratifying a patient for a treatment”, and recites “comparing the determined level, mutation status, and/or activity” of said at least one first and at least one second biomarker in steps (b) and (c) with a reference sample or a reference value (which levels were determined in a provided “biological sample”), as well as “identifying a differential level, mutation status, and/or activity of” the biomarkers in the biological sample “compared to a reference sample or reference value”, and “deciding in favor of or against said treatment based on said differential level, mutation status, and/or activity”. Each of the activities of “comparing” and “deciding”, as well as aspects of the “identifying” that correspond to the “comparing” of (d) of the claim, are also activities that may be performed in the human mind, i.e., abstract ideas.
Regarding all claims, it is also noted with regard to all claims that while the “determining the level, mutation status, and/or activity” of biomarkers “in a biological sample that is provided as an initial step of the claimed methods requires the performance of active method steps to achieve such “determining”, the properties of biomarker levels, mutation status, and activity of the recited markers in a biological sample are natural phenomena/laws of nature, i.e., another type of judicial exception (JE).
Further, regarding the amendment of independent claim 1 to reciting “selecting or administering a treatment’, and the amendment of claim 8 to add the recitation “administering said treatment to said patient when it is decided in favor of said treatment”, these activities as set forth in the claims are clearly conditional/ contingent (rather than required) steps/actions. “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met” (MPEP 2111.04(II)); thus, the broadest reasonable interpretation (BRI) of claim 1 does not require the “selecting or administering”, and the BRI of claim 8 does not required the recited “administering”. Accordingly, these activities cannot be relied upon as adding any type of practical application. “A claim whose BRI covers both statutory and non-statutory embodiments embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter” (MPEP 2106.03(II)).
These judicial exceptions (JEs) are not integrated into a practical application because the active method steps set forth in the claims of providing a biological sample and determining levels/mutation status/activity of biomarkers therein are data gathering steps that do not add a meaningful limitation to the method as they are insignificant extrasolution activity, rather than any type of application/implementation of a JE. With particular regard to claim 8 and claims dependent therefrom, it is noted that while the claims recite “stratifying a patient for a treatment”, the activity in the claim related to treatment is “deciding in favor of or against said treatment”, which (as already noted) is a JE, rather than an application of a JE. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the activities of providing a biological sample and “determining” levels/mutation status/activity of biomarkers therein, whether considered individually or in combination, clearly constituted well-understood, routine, and conventional activity as of Applicant’s effective filing date; see again, e.g., Wu et al (BMC Cancer 19:326 [April 2019]; cited in IDS) and Delaunay et al (Nature Cell Biology 21:552-559 [May 2019]; cited in IDS).
Further, even to the extent that the claims may require, e.g., determining levels/status of a particular biomarker or biomarker combination that is not disclosed in the prior art (as is the case with respect to, e.g., the combination of claim 10), the levels/mutation status/activity of such biomarkers is (as noted above) another type of JE, rather than something “more” than a JE. An inventive concept cannot be furnished by a judicial exception (i.e., a law of nature/natural phenomenon/abstract idea) itself (see MPEP 2106.05(I)). Thus, Applicant’s claims are not directed to patent eligible subject matter.
Dependent claim 3 is further limiting of JEs of the claims (specifically, of the type of conclusions drawn regarding a sample), and does not add anything constituting an application of a JE, or add anything “significantly more” than a JE. Claim 4 recite broad categories of types of biological samples that may be employed in the claimed methods, setting forth a limitation on where data is to be gathered from, rather than adding an application/implementation of a JE; further, such sample types (“a tissue sample or a body liquid sample”, etc.) were clearly well-known types of biological samples for expression/mutation/activity testing, in routine and conventional use, as of Applicant’s effective filing date. Claim 5 sets forth broad categories of well-known methods/ techniques for testing biological samples with respect to expression levels, etc.; again, the claim is further limiting of data gathering, and does not set forth any type of application of a JE, or add anything “significantly more”. Claim 6 recites what is indicated by possible outcomes of the performance of the active method steps of the claims; nothing corresponding to an application/implementation of a JE, or something “significantly more” than a JE, is added. With further regard to dependent claim 10, while this claim recite “determining” more particular biomarkers/biomarker combinations, this constitutes a further limitation on the type of data gathered, rather that setting forth any type of practical application/implementation of a JE; further, the active steps required to achieve such “determining” (e.g., to measure biomarker expression levels in a biological sample) was well-known as of Applicant’s effective filing date, and the outcome of such testing with regard to various markers – e.g., elevated or reduced expression in association with a disease such as cancer – is (as already noted) another type of JE, rather than something “more” than a JE. Claim 11 recites further decisions that are made based on possible outcomes of the active steps of claim 8; the claims sets forth a more particular abstract idea rather than any type of application of JE, and does not recite anything constituting “more” than a JE. Claims 12 and 17 are similarly further limiting only of a JE (reciting a more particular type of treatment with regard to which “deciding” occurs); nothing constituting an application of a JE or something more than a JE is added. Finally, dependent claim 13 requires that “the method is a non-invasive method”; this claim is further limiting of the type of data gathering performed, but adds nothing that might constitute an application of a JE, and “non-invasive” diagnostic methods involving the measurement of expression levels, etc., were clearly well-understood, routine, and conventional as of Applicant’s effective filing date.
The reply of 05 May 2026 traverses the prior rejection of claims under 35 USC 101 on the following grounds.
The Reply states that claim 1 has been amended to recite “selecting or administering a treatment….”, and that “at least this limitation provides a clear practical application of biomarker analysis in a method of medical treatment”, further urging that the recitation of such selecting or administering a treatment is a “concrete application in the field of medicine” that impacts patient care (page 12 bridging to page 13). This argument has been thoroughly considered but is non-persuasive at least because the “selecting or administering” of claim 1 is not a required method step (as is discussed in the above rejection of the amended claims). It is also noted that “selecting” embraces decision making/thought, and is thus another abstract idea (again, as is discussed in the current rejection of the claims).
Applicant also argues that “claim 1 recites a specific and non-generic combination of biomarkers associated with two distinct biological pathways”, which is urged to reflect “a human-designed analytical approach used to guide treatment decisions” (Reply page 13). This argument has been thoroughly considered but is not persuasive at least because (again) the claims do not in fact require the referenced treatment (or other action/implementation of the recited JEs), such that a practical application implementing the JE is lacking from the claims.
Finally, Applicant presents analogous arguments regarding independent claim 8, which arguments rely on the claim requiring administering a treatment, and ”thereby applying the biomarker information in a practical and clinically meaningful way” (Reply page 13). These arguments are non-persuasive for essentially the same reasons discussed above regarding claim 1 (as the “administering” of claim 8 is not required by the current claim language). 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).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANA B JOHANNSEN whose telephone number is (571)272-0744. The examiner can normally be reached Monday-Friday, 7:30 am-3:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached at (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANA B JOHANNSEN/Primary Examiner, Art Unit 1682
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