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 .
Election/Restriction
Applicant's election with traverse of Group I (claims 1-9) in the reply filed on 05/18/2026 is 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 § 818.03(a)). Claim(s) 10-13 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim.
Status of Claims
Claims 1-9 are under examination.
Claims 10-13 are withdrawn.
Priority
Applicant’s claim for the benefit of foreign priority under 35 U.S.C. 119(a)-(d) to Taiwan patent application No. 110139746, filed on October 26, 2021 is acknowledged. The certified copy of the aforementioned application is acknowledged. However, applicant has not filed an English translation of the aforementioned application as required by 35 U.S.C. 119(b). However, Applicant is reminded that the filing date of the foreign priority document is not the effective filing date of the U.S. application. MPEP §§ 201.13 III. and 706.02 V. Thus, the one-year bar of 35 U.S.C. § 102(b) dates from the effective U.S. filing date and not from the foreign filing date. This means that a reference with a publication or patent date less than a year before the priority date but more than a year before the effective U.S. filing date, is a reference under 35 U.S.C. § 102(b). This also applies when the claimed invention had been into a public use or on sale in this country more than one year prior to the effective U.S. filing date. 35 U.S.C. § 119(a). Accordingly, the effective filing date for the instant application is 04/25/2022.
Information Disclosure Statement
The information disclosure statement (IDS) document(s) submitted 04/25/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS document(s) has/have been fully considered by the examiner.
Drawings
The drawings filed 04/25/2022 are acknowledged and acceptable.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The Supreme Court has established a two-step framework for this analysis, wherein a claim does not satisfy § 101 if (1) it is “directed to” a patent-ineligible concept, i.e., a law of nature, natural phenomenon, or abstract idea, and (2), if so, the particular elements of the claim, considered “both individually and ‘as an ordered combination,” do not add enough to “transform the nature of the claim into a patent-eligible application.” Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (quoting Alice, 134 S. Ct. at 2355).
Guidance: Step 1.
Under the broadest reasonable interpretation, the claimed invention (claim 1 being representative) is directed to a method for performing a process and therefore falls within one of the four statutory categories.
A. Guidance Step 2A, Prong 1
The Revised Guidance instructs us first to determine whether any judicial exception to patent eligibility is recited in the claim. The Revised Guidance identifies three judicially-excepted groupings identified by the courts as abstract ideas: (1) mathematical concepts, (2) certain methods of organizing human behavior such as fundamental economic practices, and (3) mental processes. In this case, the following steps encompass an abstract idea for the reasons set forth below:
(c) evaluating a clinical treatment score post-5 years (CTS5) of the patient; wherein high expression levels of both the pyruvate kinase and the O-GlcNAc, and high score of the CTS5 indicate that the patient has a poor prognosis.
Mental Processes
With regards to said evaluating, this step is recited at a high level of generality (without any technological details directed to how it is performed) and does not explicitly require a computer. In addition, doctors routinely perform clinical evaluations using their brains. As such, this step encompasses a mental process of observing data, performing analysis, and making a judgement. MPEP 2106.04(a)(2), section III. It is important to note that a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016). [Step 2A, Prong 1: YES].
B. Guidance Step 2A, Prong 2
Having made that determination, under the 2019 Guidance, the examiner next determines whether there are additional elements beyond the recited abstract idea(s) that integrate them into a practical application. In this case, the additional steps/elements that are not part of the abstract idea are as follows:
(a) detecting an expression level of pyruvate kinase in a sample from the patient;
(b) detecting an expression level of O-linked P-N-acetylglucosamine (0-GlcNAc) in the sample of step (a);
In this case, the detecting steps are recited at a high level of generality (without regard for any particular techniques or tools) and result in gathering data for use by the abstract idea. Accordingly, these steps amount to insignificant extra-solution activity and are not indicative of an integration into a practical application. See MPEP 2106.05(g).
Notably, MPEP 2106.04(d)(1) lists the following considerations for evaluating whether additional elements integrate a judicial exception into a practical application:
An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
In summary, the claimed invention does not provide any objective evidence of an improvement to the technology, nor does the specification explain the details of an unconventional technical solution expressed in the claim, or identify technical improvements realized by the claim over the prior art. See MPEP 2106.04(d)(1) and MPEP 2106.05(a). Therefore, even when viewed in combination, these additional steps/elements do not integrate the recited judicial exception into a practical application. [Step 2A, Prong 2: NO].
C. Guidance Step 2B:
This part of the eligibility analysis evaluates whether the claim as a whole amount to significantly more than the recited exception i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. See MPEP 2106.05.
As discussed above, the non-abstract steps/elements amount to nothing more than insignificant extra-solution activity. Moreover, Tanner et al. (WO 2008/082730) teaches methods of utilizing biomarkers to identify patients for treatment or to monitor response to treatment, including detecting expression levels of PKM2 and O-GlcNAc [see entire and Tables I-XX]. Kuo et al. (Diagnostics, 2021, 11, 1460, pp.1-15; Pub. Date: 08/12/ 2021) also teaches a method for determining expression levels of O-GlcNAc and PKM2 in HER2 breast cancer patients. Therefore, even upon reconsideration, there is nothing unconventional with regards to the above non-abstract elements/steps. See MPEP 2106.05(d)(Part II). Thus, the independent claim(s) as a whole do not amount to significantly more than the exception itself. Therefore, the claim(s) is/are not patent eligible. [Step 2B: NO].
Dependent Claims
Dependent claims 2-9 have also been considered under the two-part analysis but do not include additional steps/elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons. Regarding claim(s) 2-5, these claims further limit the type of markers being used or how the expression levels are being detected and therefore are directed to insignificant extra-solution activity and are not patent eligible for reasons set forth above (Step 2A, prong 2 and Step 2B). Regarding claims 6-8, these claims further limit the specificity of the abstract idea or the nature of the data being used and therefore are not patent eligible for reasons set forth above (Step 2A, prong 1). Therefore, the claims as a whole are not patent eligible.
Claim rejections - 35 USC § 112, 2nd Paragraph
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 1-9 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 pre-AIA the applicant regards as the invention. Claims that depend directly or indirectly from claim(s) 1 are also rejected due to said dependency.
Claim 1 recites “(c) evaluating a clinical treatment score post-5 years (CTS5) of the patient; wherein high expression levels of both the pyruvate kinase and the O-GlcNAc, and high score of the CTS5 indicate that the patient has a poor prognosis.” The above limitation is problematic for the following reasons. (1) The artisan would recognize that data must be obtained before any type of evaluation can be made. However, in this case, there is no previous step in the claim that provides, calculates, or determines a “clinical treatment score post-5 years” such that it can be subsequently evaluated as claimed. Accordingly, there is lack of antecedent basis for this limitation as the claimed “evaluating” step is relying upon information that has not been previously introduced. As a result, the claim is also rejected under 35 USC 112(b) for missing essential matter (e.g. calculating CTS5 for the patient) since it fails to interrelate the essential elements of the claimed invention. See also MPEP 2172.01. Clarification is requested via amendment.
(2) To the extent that applicant intends for CTS5 to be calculated, it is unclear in what way this score is being determined. Such generic functional claim language amounts to descriptions of problems to be solved and covers all means or methods of performing the claimed function. A review of the specification teaches clinical treatment score post-5 years (CTS5) is a calculation tool integrating four clinical data including tumor size, tumor grade, patient age, and the number of nodes to estimate the risk of breast cancer [0039]. However, examples are not limiting definitions and it is improper to import narrowing limitations into the claims. MPEP 2111.01. As a result, it is unclear what computational techniques are included or excluded by the claim language such that one of ordinary skill in the art would know how to avoid infringement. Clarification is requested via amendment.
(3) With regards to the term “high score”, this is a relative term and the specification does not provide any limiting definitions, specific properties, or scoring criteria indicating the scope of this term, i.e. the result is subjective and imperceptible. Clarification is requested via amendment.
Claim 8 recites “by analysis of Tumor Immune Estimation Resource (TIMER)”. It is unclear what is meant by TIMER in the claimed context. A review of the specification does not provide any limiting definition that would serve to clarify the scope, i.e. in what way is “analysis of TIMER” achieved. To the extent that applicant intends for TIMER to be a computational tool for tumor analysis, applicant is reminded that the instant claims do not even require using a computer. Clarification is requested via amendment.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuo et al. (Diagnostics, 2021, 11, 1460, pp.1-15; Pub. Date: 08/12/ 2021).
It is noted that the cited prior art reference shares at least one common inventor but is a different inventive entity.
Regarding claim(s) 1, Kuo teaches a method for determining prognostic significance of O-GlcNAc and PKM2 in HER2 breast cancer patients. In particular, Kuo teaches detecting expression levels of O-GlcNAc and PKM2 using immunoassays [Section 2]. Kuo teaches evaluating the expression level data using various statistical tool/techniques [Section 2.4], including regression analysis and/or CTS5 scoring, and determining poor prognosis based on high expression levels [Section 3.1 and 3.2].
Regarding claim(s) 2, 3, 4, Kuo teaches PKM2 and evaluating patients with HR+/HER2- luminal BC [Abstract]. Regarding claim(s) 5, Kuo teaches IHC methods for analysis [Section 2.2 and 2.3]. Regarding claim(s) 6, 7, Kuo teaches DFS analysis up to 120 months (10 years) [Sections 2.4, 3.2, and Figure 2]. Regarding claim(s) 8, 9, Kuo teaches statistical analysis of expression levels [Section 2.4], which broadly reads on TIMER absent any limiting definition to the contrary, and comparing top quarter and bottom quartile groups [page 6].
Cited Prior Art
The following prior art made of record and not presently relied upon is considered pertinent to applicant' s disclosure. Applicant is reminded that prior art rejections under 35 U.S.C. 102 and/or 35 U.S.C. 103 may be applied in the next Office action in light of applicant's amendments, and that the next Office action can properly be made "Final" if these rejections are necessitated by amendment. See MPEP 706.07.
Noordhoek et al. (Journal of Clinical Oncology, 2020, Vol. 38, Issue 28, 3272-81) teaches using CTS5 estimates for categorizing patients who have been disease free for 5 years into low, intermediate, and high risk and calculating an absolute risk for developing distant recurrences between 5 and 10 years.
Li et al. (Cancer Res; 2017; 77(21); pp.e108-e110) teaches a web server for comprehensive analysis of tumor-infiltrating immune cells (TIMER).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619
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