DETAILED ACTION
Status
This Final Office Action is in response to the communication filed on 20 July 2026. Claims 1-3, 5-7, and 9-10 have been cancelled, claims 4 and 8 have been amended, and claims 11-13 have been added. Therefore, claims 4, 8, and 11-13 are pending and presented for examination.
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 Amendment
A summary of the Examiner’s Response to Applicant’s amendment:
Applicant’s amendment overcomes the rejection(s) under 35 USC § 112; therefore, the Examiner withdraws the rejection(s).
Applicant’s amendment does not overcome the rejection(s) under 35 USC § 101; therefore, the Examiner maintains the rejection(s) while updating phrasing in keeping with current examination guidelines.
Applicant’s amendment overcomes the rejection(s) under 35 USC §§ 102 and/or 103; therefore, the Examiner places new grounds of rejection.
Applicant’s arguments are found to be not persuasive; please see the Response to Arguments below.
Priority
The Examiner notes that Applicant requests acknowledgement of certified copies of priority documents being received (“Applicant respectfully requests the Examiner to check Box 12)a)1 on the Office Action Summary page indicating that acknowledgment is made to Applicant's claim to foreign priority and receipt of the Certified Copy of the Priority Document as lodged in the USPTO's Patent Center with a mailroom date of May 7, 2025” – 20 July 2026 Remarks at 6). However, the 7 May 2025 document received is a/the “CERTIFICATE OF AVAILABILITY OF A CERTIFIED PATENT DOCUMENT IN A DIGITAL LIBRARY” – i.e., it indicates availability in general, not actual receipt. It is further noted that the 2 September 2025 entry in the record indicates a “PRIORITY DOCUMENT EXCHANGE FAILURE STATUS REPORT” where “An attempt by the Office to electronically retrieve, under the priority document exchange program, the foreign application 10-2024-0044755 to which priority is claimed has FAILED on 09/02/2025”.
Therefore, apparently, no actual reception of priority documents has been achieved, and the Examiner should not, or cannot, acknowledge receipt at this time.
Claim Objections
Claim 4 is objected to because of the following informalities: “step (a-1)” is recited at element (b); however, there is no current step (a-1) – since this is apparently the same step as was at canceled claim 1, this is being interpreted as being “step (a)”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 13 is 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.
Claim 13 recites the limitation "the low risk group" in line 3. There is insufficient antecedent basis for this limitation in the claim – there are no risk groups of any type at the current claims.
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 4, 8, and 11-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a method (claims 4 and 11) and apparatus (claims 8 and 12-13), which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 4 recites a method for predicting mediastinal lymph node metastasis and determining whether invasive staging should be performed in a lung cancer patient, the method comprising: (a) obtaining information regarding a lung cancer patient's age, a histological type of a tumor, a location of the tumor, a size of the tumor, a clinical lymph node stage determined by CT, and a clinical lymph node stage determined by PET-CT; (b) deriving a probability of mediastinal lymph node metastasis in the lung cancer based on the information obtained in step (a-1), according to Equation 1, Equation 2, or both,
[Equation 1]
PNG
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165
611
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Greyscale
[Equation 2]
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media_image2.png
165
614
media_image2.png
Greyscale
wherein, in Equations 1 and 2, p represents a predicted probability of mediastinal lymph node metastasis (N2-3), and I represents an indicator variable for an individual clinical factor; (c) predicting that the lung cancer patient has mediastinal lymph node metastasis if the probability derived in step (b) is greater than or equal to a predetermined threshold; and (d) performing invasive staging on the lung cancer patient predicted to have mediastinal lymph node metastasis in step (c).
Independent claim 8 is analyzed in a similar manner to claim 4 since directed to an apparatus comprising at least one processor; and at least one memory, wherein the at least one processor is configured to perform the same predicting as based on the same equations as at claim 4, except that the verb “calculate” is used at step (ii), instead of “derive” at claim 4 step (b), and where claim 4 recites “performing invasive staging”, claim 8 only recites to “output information indicating that invasive staging should be performed on the lung cancer patient predicted to have mediastinal lymph node metastasis in (iii)”.
The dependent claims (claims 11-13) appear to be encompassed by the abstract idea of the independent claims since they merely indicate the threshold probability (claims 11-12), and/or outputting that invasive mediastinal staging is not recommended for a patient in the low risk group.
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of calculating the prediction of metastasis in lung cancer; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the Mathematical concepts (e.g., relationships, formulas, equations, and/or calculations) grouping(s) of subject matter since the claims recite specific formulas or equations (i.e., Equations 1 and 2), merely obtain or gather information, and then perform calculations on that information according to Equations 1 and 2.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are performing invasive staging (at claim 4), an apparatus comprising at least one processor; and at least one memory, wherein the at least one processor is configured to perform the same predicting as based on the same equations (at claim 8). These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition (there is no medical disease or condition, much less a treatment or prophylaxis for one), implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The Examiner has considered whether particular treatment and/or prophylaxis analysis (at MPEP § 2106.04(d)(2)) is applicable with respect to Prong 2 analysis, and it appears that this analysis is not applicable.
First, the “invasive staging” is, or includes, “invasive mediastinal staging” as described at Applicant ¶¶ 0003-0004 (as submitted, 0004-0005 as published) – indicating that this is generally, or primarily, a fine needle aspiration (i.e., further sampling), and not actually a treatment or a prophylaxis.
Second, the analysis indicated at MPEP § 2106.04(d)(2)(a) regarding “The Particularity Or Generality Of The Treatment Or Prophylaxis” is more similar to the second example therein. The first example is where “The claim also recites ‘administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype.’ This administration step is particular, and it integrates the mental analysis step into a practical application”; however, the claim indication of performing (even if considered a form of prophylaxis) does not modify or alter the traditional or usual, known, further analysis and therefore does not appear analogous. The second example is that “Conversely, consider a claim that recites the same abstract idea and ‘administering a suitable medication to a patient.’ This administration step is not particular, and is instead merely instructions to ‘apply’ the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application.” This appears more analogous since any invasive staging would be included in the claims, but also the indicated or described aspiration is the same general procedure typically prescribed to be performed – it is thus considered general and not particular to the invention.
Third, MPEP § 2106.04(d)(2)(b) is related to “Whether The Limitation(s) Have More Than A Nominal Or Insignificant Relationship To The Exception(s)”, where the invention is indicated at Applicant ¶¶ 0003-0004 (as submitted, 0004-0005 as published) as merely adding the histological type and patient age to the factors considered – i.e., it is the equations that constitute the exception, and whether the staging or aspiration is performed does not actually limit or have any apparent or significant relationship to that exception.
Fourth, MPEP § 2106.04(d)(2)(c) relates to “Whether The Limitation(s) Are Merely Extra-Solution Activity Or A Field Of Use”, where the invasive staging or aspiration being performed is considered to be merely insignificant extra-solution activity with respect to the equations or formulas claimed as part of the abstract idea.
Therefore, the claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity.
The Examiner notes that even if the performing of the invasive staging were considered under Step 2B analysis, Applicant indicates that this is the standard or normal, typical recommendation – the invention is apparently the equations or formulas as adding the histological type and patient age as factors being considered.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility. Applicant ¶¶ 0042 and 0058 (as submitted, 0041 and 0053 as published) appears to be the most detailed description of a computer or apparatus as claimed, or for performing the method(s) claimed, but merely indicates “The apparatus may be an apparatus for driving a web page, an application, or the like, and may include, for example, a computing device, a mobile device, a server, or the like” comprised of general or generic components. Therefore, the description merely indicates a generic computer at best.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
Allowable Subject Matter
Claims 4, 8, and 11-13 are indicated as allowable over the prior art of record.
The following is a statement of reasons for the indication of allowable subject matter:
Claims 4 and 8 recite the specific equations above – where Applicant ¶ 0029 (as submitted, 0028 as published) indicates that “The mediastinal lymph node metastasis prevalence prediction model according to Equation 1 may be referred to as PLUS-M. Furthermore, the mediastinal lymph node metastasis diagnostic prediction model according to Equation 2 may be referred to as PLUS-E. PLUS-M is an abbreviation for Prediction model for Lung cancer Staging-Mediastinal metastasis, and …. PLUS-E is an abbreviation for Prediction model for Lung cancer Staging-mediastinal metastasis”.
The Examiner does not find the specific indicated equations with the exact weighting factors as disclosed by the prior art.
As such, the claimed equations are indicated to be allowable over the prior art of record.
Response to Arguments
Applicant's arguments filed 20 July 2026 have been fully considered but they are not persuasive.
Applicant first requests acknowledgement that priority documents are received; however, as noted above, although a retrieval request was attempted, apparently no actual reception of priority documents has been achieved, and the Examiner should not, or cannot, acknowledge receipt at this time.
Applicant then argues the 112(f) interpretation and related 112 rejections (Remarks at 6-8); however, as indicated above, since the amendment appears to overcome the rejections, the rejections are withdrawn and it is noted that the argument is therefore considered to be moot and not persuasive.
Applicant then argues the 101 rejections, alleging “the claimed method applies the prediction result to guide a specific clinical intervention for a particular patient, namely determining and performing invasive staging. The additional limitations integrate any alleged judicial exception into a practical application that directly affects the medical management of the patient and therefore impose meaningful limits on the claims” (Remarks at 8-9). However, the claims recite specific equations or formulas, and then further gather data so as to perform calculations using those equations or formulas; therefore, the claims are squarely in the mathematical concepts grouping. Further, with regard to a practical application, the Examiner has fully considered the amendments and claims – both as individual elements and as a whole, or ordered, combination – and notes that the invention is merely adding histological type and patient age as further factors (as part of the equations claimed) for consideration. This is to say, the equations or formulas themselves are what the invention is directed to, and current eligibility analysis does not indicate eligibility for equations or formulas, nor for performing calculations based on those mathematical concepts.
Applicant then argues the prior art rejections (Remarks at 9); however, the prior art rejections are withdrawn and therefore the argument is considered moot and not persuasive.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Burlew et al., Anatomy, Thorax, Mediastinal Lymph Nodes. [Updated 2023 Jul 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK532863/ explaining the mediastinal compartment, locations, lymph node presence, and most current mapping (at 1, Introduction).
Balachandran et al., Nomograms in oncology: more than meets the eye. Lancet Oncol. 2015 Apr;16(4):e173-80. doi: 10.1016/S1470-2045(14)71116-7. PMID: 25846097; PMCID: PMC4465353. Downloaded 10 April 2026 via https://pmc.ncbi.nlm.nih.gov/articles/PMC4465353/, and indicating that “Nomograms are commonly used tools to estimate prognosis in oncology and medicine. With the ability to generate an individual numerical probability of a clinical event by integrating diverse prognostic and determinant variables, nomograms fulfill our desire for biologically and clinically integrated models and our drive towards personalized medicine. Rapid computation through user friendly digital interfaces, together with increased accuracy, and more easily understood prognoses compared to conventional staging, allow for seamless incorporation of nomogram derived prognosis to aid in clinical decision making. This has lead to the ubiquitous appearance of nomograms on the internet and in medical journals, and increasing nomogram use by patients and physicians alike. However, the statistical foundations of nomogram construction, their precise interpretation, and evidence supporting their use is commonly misunderstood, leading to an under appreciation of the inherent uncertainties regarding nomogram use. We provide a systematic, practical approach to evaluating and comprehending nomogram derived prognoses, with particular emphasis on clarifying common misconceptions and highlighting limitations.” (at Summary, e173).
Streed, Joel, What the heck is a nomogram? And other medical research questions answered, Mayo Clinic, dated 16 November 2017, downloaded 10 April 2026 from https://newsnetwork.mayoclinic.org/discussion/what-the-heck-is-a-nomogram-and-other-medical-research-questions-answered/, indicating “what the heck is a nomogram? Basically it’s a set of lines that each have a scale marked off … and arranged in a way that connecting a straight line between two known characteristics will allow you to determine a third one” (at p. 3 of 4).
Guarga et al., Trends in lung cancer incidence by age, sex and histology from 2012 to 2025 in Catalonia (Spain). Sci Rep 11, 23274 (2021). https://doi.org/10.1038/s41598-021-02582-8, downloaded 8 September 2026 from https://www.nature.com/articles/s41598-021-02582-8, indicating “In this study we describe recent trends in lung cancer incidence by sex, age and histological type in Catalonia and project changes according to histology by 2025. Bayesian age period‑cohort models were used to predict trends in lung cancer incidence according to histological type from 2012 to 2025, using data from the population‑based Catalan cancer registries. Data suggest a decrease in the absolute number of new cases in men under the age of 70 years and an increase in women aged 60 years or older.” (at Abstract).
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/SCOTT D GARTLAND/
Primary Examiner, Art Unit 3685
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