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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 January 2026 has been entered.
Response to Amendment
Claims 1-27, 38, and 50-55 have been cancelled. Claims 28, 40, 49, and 56 have been amended and Claims 59-60 have been newly added, as requested in the amendment filed on 30 January 2026. Following the amendment, claims 28-37, 39-49, and 56-60 are pending in the instant application, and are under examination in the instant office action.
Withdrawn Objection:
As currently amended, the objection to Claim 49 is withdrawn.
Withdrawn Rejection:
As currently amended, Claim 40 now further limits the scope of the parent claim. Therefore, the rejection of Claims 40-43 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn.
As currently amended, the rejection of Claims 28-49 and 56-58 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn. The claims now have improved clarity.
Claim Rejections - 35 USC § 101 (Maintained)
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.
As currently amended, Claims 28-37, 39-49, and 56-60 are rejected under 35 U.S.C. 101, for reasons of record in the previous Office action, as applied to claims 28-49 and 56-58.
On pages 8-9 of Remarks filed 30 January 2026, Applicant traverses the rejection on the following grounds. Applicant asserts the amendment to Claims 28 and 56 to recite that the method includes a computer comprising a pattern recognition algorithm in communication with a database, as well as the use of ATR FTIR spectrometer, obviates the rejection. The specification is cited as stating the algorithms may be computer software installed on a computer and the database comprises pre-correlated signatures stored in the database as a training set. Applicant states the claims now are not directed to an abstract idea but rely upon “technical features, including the use of a computer and a predictive model that has been trained to identify differences in a spectroscopic signature when in communication with a database comprising spectroscopic signatures obtained from subjects having a lymphoma or a glioma”.
While all of these arguments have been reviewed in full, they are not found persuasive to overcome the rejection for the following reasons. As currently amended, the claims still recite judicial exceptions: (1) analyzing with a computer comprising a pattern recognition algorithm in communication with a database comprising one or more pre-correlated signatures; (2) determining the subject has a glioma or lymphoma; and (3) correlating infrared absorbance differences between the obtained spectroscopic signature of the sample and the one or more pre-correlated signatures.
Regarding the newly added limitation of “correlating” the infrared absorbance differences between the obtained spectroscopic signature from the sample and “one or more pre-correlated signatures previously determined to be from lymphoma and/or glioma subjects”. As claimed Applicant is admitting that a blood sample’s infrared absorbance is correlated to the presence of lymphoma and/or glioma pathology. This is the very definition of a natural correlation judicial exception, wherein specific blood components, which can be detected by ATR-FTIR spectrometry, are correlated to a disease pathology. Additionally, the court in Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) held that claims to a “process of organizing information through mathematical correlations”’ are directed to an abstract idea. See MPEP2106.04(a)(2)(I). Therefore, this new limitations adds additional judicial exceptions to the claims.
Step 2A, Prong Two asks whether the additional elements integrate the judicial exceptions into a practical application. For this analysis, it should be noted that the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
The Supreme Court recognized mental processes can be performed on a computer in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures "can be carried out in existing computers long in use, no new machinery being necessary." 409 U.S at 67, 175 USPQ at 675. An example of a case identifying a mental process performed in a computer environment as an abstract idea is Symantec Corp., 838 F.3d at 1316-18, 120 USPQ2d at 1360. In this case, the Federal Circuit relied upon the specification when explaining that the claimed electronic post office, which recited limitations describing how the system would receive, screen and distribute email on a computer network, was analogous to how a person decides whether to read or dispose of a particular piece of mail and that "with the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper". 838 F.3d at 1318, 120 USPQ2d at 1360. Another example is FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 120 USPQ2d 1293 (Fed. Cir. 2016). The patentee in FairWarning claimed a system and method of detecting fraud and/or misuse in a computer environment, in which information regarding accesses of a patient’s personal health information was analyzed according to one of several rules (i.e., related to accesses in excess of a specific volume, accesses during a pre-determined time interval, or accesses by a specific user) to determine if the activity indicates improper access. 839 F.3d. at 1092, 120 USPQ2d at 1294. The court determined that these claims were directed to a mental process of detecting misuse, and that the claimed rules here were "the same questions (though perhaps phrased with different words) that humans in analogous situations detecting fraud have asked for decades, if not centuries." 839 F.3d. at 1094-95, 120 USPQ2d at 1296. An example of a case in which a computer was used as a tool to perform a mental process is Mortgage Grader, 811 F.3d. at 1324, 117 USPQ2d at 1699. The patentee in Mortgage Grader claimed a computer-implemented system for enabling borrowers to anonymously shop for loan packages offered by a plurality of lenders, comprising a database that stores loan package data from the lenders, and a computer system providing an interface and a grading module. The interface prompts a borrower to enter personal information, which the grading module uses to calculate the borrower’s credit grading, and allows the borrower to identify and compare loan packages in the database using the credit grading. 811 F.3d. at 1318, 117 USPQ2d at 1695. The Federal Circuit determined that these claims were directed to the concept of "anonymous loan shopping", which was a concept that could be "performed by humans without a computer." 811 F.3d. at 1324, 117 USPQ2d at 1699. Another example is Berkheimer v. HP, Inc., 881 F.3d 1360, 125 USPQ2d 1649 (Fed. Cir. 2018), in which the patentee claimed methods for parsing and evaluating data using a computer processing system. The Federal Circuit determined that these claims were directed to mental processes of parsing and comparing data, because the steps were recited at a high level of generality and merely used computers as a tool to perform the processes. 881 F.3d at 1366, 125 USPQ2d at 1652-53.
The case law cited above is applicable to the instant claims because analyzing an obtained spectroscopic signature with one or more signatures associated with glioma and/or lymphoma pathology can be performed with the human mind. The computer algorithm of the instant claims is merely being used to “determine infrared absorbance differences between the pre-correlated signatures” and the infrared absorbance signature obtained from the blood sample. Although time consuming, differences in infrared absorbances can be detected by the human eye. The following image (below) is provided as an example of how IR spectra from molecules having C=O peaks differ in the region around 1630-1800 cm-1, and can be visually compared. Therefore, the algorithm of the instant claims is merely performing the same task as can be performed in the human mind.
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The claims have been amended to recite a particular machine an Attenuated Total Reflection FTIR spectrometer. MPEP 2106.05(b) discusses how a particular machine may be evidence of integrating a judicial exception into a practical application. The MPEP states: “It is noted that while the application of a judicial exception by or with a particular machine is an important clue, it is not a stand-alone test for eligibility. Bilski v. Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 (2010)”. MPEP 2106.05(b)(I) further states: “If applicant amends a claim to add a generic computer or generic computer components and asserts that the claim recites significantly more because the generic computer is 'specially programmed' (as in Alappat, now considered superseded) or is a 'particular machine' (as in Bilski), the examiner should look at whether the added elements integrate the exception into a practical application or provide significantly more than the judicial exception. Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 223-24, 110 USPQ2d 1976, 1983-84 (2014). See In re Alappat, 33 F.3d 1526, 1545, 31 USPQ2d 1545, 1558 (Fed. Cir. 1994); In re Bilski, 545 F.3d 943, 88 USPQ2d 1385 (Fed. Cir. 2008).” Such is the case here, where independent claims 28 and 56 have been amended to recite ATR-FTIR spectroscopy but this machinery/methodology has been well-established, routine and conventionally used in the art prior to the filing date of the application (see attached PubMed search report demonstrating routine use since the 1980s). Thus, analogous to the claims in Benson, no new machinery is necessary. The use of the machine either for performing a spectroscopic analysis or for analyzing the spectroscopic signature do not integrate the mental processes into a practical application thereof. The additional elements fail to provide any of the considerations with respect to integration set forth in MPEP 2106.05(a-c), (e) and (h). The additional elements do not transform the judicial exceptions into a different article. The additional elements confer no specific improvement within the field of use. While newly added claims recite the new element of “a filtered blood sample”, the following prior art teaches this was a well-established practice before the effective filing date of the application. US Patent 5118428, issued 2 June 1992, teaches processes for removing red blood cells from whole blood comprising filtering “wherein the filtering is carried out in a dispense tube tip containing glass fiber and cotton that dispenses the RBC-free sample onto a test device” (claim 10) was well-established routine and conventional practice at the time of filing. There is no particular machine; nor is there particular treatment or prophylaxis that integrates the judicial exceptions into a practical application.
Regarding the method claimed, the Examiner has provided evidence that the specification sets forth no new method or step that distinguishes over what was well-understood, routine and conventional in the art prior to filing (see previous Office action). In other words, the disclosure describes no new technology, but merely refers to techniques and elements that were known in the art at the time of filing.
Lastly, in accordance with MPEP 2106.07(a)(III)(C), the Examiner has cited publications within the field of technical expertise, that demonstrate the well-understood, routine, conventional nature of the additional elements (see previous Office action citing Hands et al., 2014; Ghimire et al., 2017; and Yan et al., 2009). Taken together, the claimed steps/elements recited in addition to the judicial exception(s), alone or in combination, do not make an inventive contribution over the methods that were known in the art prior to filing.
For all of these reasons, Claims 28-37, 39-49, and 56-60 are directed to the judicial exception without significantly more and the rejection is maintained.
Claim Rejections - 35 USC § 112 (Maintained)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
As currently amended, Claims 28-37, 39-49, and 56-60 stand as rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, scope of enablement, for reasons of record in the previous action. Briefly, the specification provides enabling guidance for identifying a patient that has a glioma tumor based upon their IDH1 status, the method comprising isolating the <3kDa filtered serum fraction, obtaining a full spectra dataset (4000-800 cm-1) by performing ATR-FTIR spectroscopy on said fraction (see Figure 7 and ATR-FITR analysis on pages 29-33 of the specification), detecting a significant spectral difference at around ~1650cm-1 (Figure 9b) that indicates the presence of an IDH1 mutation relative to IDH1-wildtype serum, wherein the patient is determined to have a glioma tumor when the IDH1 mutation is present.
On pages 11-16 of Remarks (Id), Applicant asserts the amendments to the claims have further defined the scope of the invention to encompass a comparison of the spectroscopic signatures to those present in a database of pre-correlated signatures. The claims now recite “a spectroscopic signature characteristic” that an algorithm can determine to be correlated with one or more pre-correlated spectroscopic signatures associated with lymphoma and/or glioma patients (the specification states “identifying a biosignature from a known patient cohort”). Applicant argues: “the present claims are enabled to detect infrared absorbance differences between any blood sample biochemical, which permits glioma/lymphoma classification between any two subject populations --- not just IDH1 mutation populations. … the Applicants have disclosed that the detection of a variety of other blood sample biochemical compounds using ATR FTIR spectroscopy capable of distinguishing between a glioma or lymphoma. An initial random forest (RF) model provides us with the biochemical differences between the lymphoma and GBM patients. The Gini plot (Figure 2) suggests the Amide II region is of importance, closely followed by the Amide I band. Between 1150-1000cm-1 there are various significant bands, relating to vibrations within nucleic material, glycogen and carbohydrates (Table 3). Applicants' Specification pg. 27 In 23 - 27 (emphasis added). The Applicants respectfully submit that the combined data of Table 3 with Figure 2 enable training of a prediction model algorithms with ATR FTIR spectral data of any biochemical compound detected within a blood sample to classify the presence of a glioma or lymphoma in a subject. As shown by the data, the present method allows the discrimination between glioma and lymphoma that is based on various blood biochemicals by comparing and correlating the complete obtained infrared absorbance spectra to pre-correlated spectra.”
While these arguments have been considered in-full they are not found to be persuasive for the following reasons. The scope of the invention is still much broader than these embodiments enabled by the disclosure as filed. Applicant’s method encompasses any “infrared absorbance differences” between an individual’s blood sample and signatures from lymphoma and/or glioma subjects. Applicant is attempting to monopolize all comparative blood spectroscopy between these cohorts. In contrast, the specification discloses specific alterations within the spectra: the Amide II region is of importance, closely followed by the Amide I band; and between 1150-1000cm-1 there are various significant bands, relating to vibrations within nucleic material, glycogen and carbohydrates (Table 3). The claims should reflect the scope of what is enabled by the specification and be limited to a method comprising identifying differences in these specific regions of the spectrum.
The examiner maintains the position that what is encompassed by the scope of the claims is broader than what is enabled by the specification. A person having ordinary skill in the art, would have to perform undue further experimentation in order to enable the claims, for their full encompassed breadth.
Therefore, Claims 28-37, 39-49, and 56-60 stand rejected under 35 U.S.C. 112, first paragraph. This rejection may be obviated by amending the claims to accurately reflect the enabled scope disclosed within the specification.
Conclusion
No claim is allowed at this time.
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/STACEY N MACFARLANE/Examiner, Art Unit 1675