Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Election/Restrictions
1. Applicant's election of Group II, claims 8-21, without traverse, filed October 28, 2025 is acknowledged. Claims 17-21 have been amended. Claims 1-16 have been cancelled. Claim 22 has been added. Accordingly, claims 17-22 are pending and are under examination.
Priority
2. This application is a Continuation of United States Patent Application Serial Number (ASN) 16/444,402 filed 06/18/2019, which is a continuation of U.S. Patent ASN 15/424,306 filed 02/03/2017, which is a continuation of U.S. Patent ASN 12/608,821 filed 10/29/2009 which claims the benefit of domestic priority of Provisional ASN 61/109,366 filed 10/29/2008. Accordingly, the priority date of this application is October 29, 2008 which is the filing date of Provisional ASN 61/109,366 from which the benefit of priority is claimed.
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.
3. Claims 17-22 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. Based upon an analysis with respect to each of these claims as a whole, these claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The claims recite a correlation between human galectin-3 as detected by binding moieties or monoclonal antibodies that bind to specific epitopes of human galectin-3 and heart failure (HF) or risk and/or progression of HF in human subjects. This judicial exception is not integrated into a practical application because the claimed invention is limited to a correlation being categorized as a law of nature/natural phenomenon or existence in nature apart from any human action without significantly more. The claims do not include additional elements that are sufficient to amount to significantly more because the judicial exception is not integrated into a significant practical application in a manner that imposes a meaningful limit on the judicial exception. This new consideration is based on case law including Vanda, for evaluation of particular treatment or prophylaxis limitations.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A Prong One
The claims recite a risk of development or progression of heart failure (HF) in a subject by measuring the level of human galectin-3 in blood sample of the subject that exceeds a predetermined threshold level of at least 15 ng/ml based on normal reference levels of human galectin-3 manifesting absence of HF. A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope. The analysis turns on whether the claim has added enough to show a practical application. See id. at 1968. In other words, the claim cannot cover the natural principle itself such that it is effectively standing alone. A bare statement of a naturally occurring correlation, albeit a newly discovered natural correlation or very narrowly confined correlation, would fail this inquiry. See id. at 1965, 1971.
The claimed steps of detecting the level of human galectin-3 in blood sample from a subject and determining that the measured level exceeds a predetermined threshold value that provides indication of HF or risk and/or progression thereof, read on mental processes, such as a clinician obtaining data results from a patient, evaluating, and forming an opinion regarding the subject’s likely diagnosis or prognosis of the disease. See the 2019 Revised Patent Subject Matter Eligibility Guidance (“2019 PEG”), issued on 1/7/2019 and available at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Such steps of comparing biomarker levels or measurements to a reference levels read on mental processes insofar as such comparison of information could take place wholly in the human mind, or by a human using pen and paper. Similar mental processes have been held by the courts to be abstract ideas, e.g., collecting and comparing known information in Classen, or comparing information regarding a sample or test subject to a control or target data in Ambry and Myriad CAFC. Such concepts as assessing abnormal results and conditions by performing clinical tests for biomarkers, determining abnormal elevated biomarker levels, and thinking about the results have also been characterized by the courts as abstract ideas. Additionally, the correlation between elevated human galectin-3 levels that exceed a predetermine threshold level and the presence HF is also categorized as a law of nature/natural phenomenon; this is a judicial exception as the correlation exists in nature apart from any human action (July 2015 Update, Quick Reference Sheet; see also Univ. of Utah Research Found. v. Ambry Genetics Corp., 774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) and In re Grams, 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)). It is not necessary that every recited element or step integrate or relate to the natural principle as long as it is applied in some practical manner. However, there must be at least one additional element or step that applies, relies on or uses the natural principle so that the claim amounts to significantly more than the natural principle itself. As set forth supra, the judicial exception recited is not integrated into a practical application because steps corresponding to mental activity, which could be performed in a practitioner’s head, are insufficient to constitute a practical application.
Step 2A Prong Two
“Integration into a practical application” requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception; evaluating whether any additional element is recited beyond the judicial exception; and determining whether the additional element(s) integrate the exception into a practical application of the exception. This new consideration is based on case law including Vanda, for evaluation of particular treatment or prophylaxis limitations.
Along with integration, the additional steps must be sufficient to ensure that the claim amounts to significantly more than the natural principle itself by including one or more elements or steps that limit the scope of the claim and do more than generally describe the natural principle with generalized instructions to “apply it.” See id. at 1965, 1968. The additional elements or steps must narrow the scope of the claim such that others are not foreclosed from using the natural principle (a basic tool of scientific and technological work) for future innovation. Elements or steps that are well-understood, purely conventional, and routinely taken by others in order to apply the natural principle, such as data acquisition, or that only limit the use to a particular technological environment (field-of-use) as in the instant application, would not be sufficiently specific. See id. at 1968.
With respect to claims 17-22, this judicial exception is not integrated into a practical application because steps corresponding to mental activity, which could be performed in a practitioner’s head, are insufficient to constitute a practical application. In this case, determining the presence of HF or risk or progression thereof, without significantly more, is a judicial exception and not a practical application thereof.
There are no subsequent steps in claims 17-22 recited that would be performed depending on the results of the assay. As in Mayo, there is no requirement that a physician should act on the measured human galectin-3 levels of the method. Rather, the claims merely inform a relevant audience about the judicial exception, at most amounting to a suggestion that the physician should take those laws into account when treating the patient, such as suggested in claim 22.
With respect to claim 22, the recitation of “repeating the method over time to obtain a trend” encompasses additional steps/ elements that are also insufficient to render the claims patent-eligible because simply appending with a generic suggestion to treat, which in this case indicates possible treatment inefficacy, specified at a high level of generality, has been held not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception. There are no subsequent steps recited that would practically apply the method depending on the results of the method, i.e. process steps that integrate the natural principle into the method and assure that it is applied in some practical manner.
Although claim 17 does invoke active steps of obtaining, contacting, detecting, and determining, this is not a practical application of the judicial exception because such steps are merely data gathering steps. The detecting/ measuring steps are recited at a high level of generality and are not tied, for example, to a particular machine, apparatus, or novel technique. Accordingly, even if the claims are interpreted as requiring a wet assay step to detect or measure the level of human galectin-3, such steps are insufficient because the purpose is merely to obtain data. This does not go beyond insignificant presolution activity, i.e., a mere data gathering step necessary to use the correlation, similar to the fact pattern in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) and Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015).
As above, there are no subsequent steps recited in claims 17-22 that would practically apply the methods depending on the results of the method, i.e. process steps that integrate the natural principle into the method and assure that it is applied in some practical manner.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
In addition to the judicial exceptions, the claims do recite steps of obtaining blood sample from a subject and detecting the level of human galectin-3 using monoclonal antibodies that bind to specific epitopes on human galectin-3. As noted above, such data gathering steps are recited at a high level of generality and are not limited, for example, to any specific or unconventional testing technique. Limitations that are necessary for all practical applications of a judicial exception, such that everyone practicing the judicial exception would be required to perform those steps or every product embodying that judicial exception would be required to include those features, would not be sufficient to confer patent eligibility. As stated supra, such additional steps/elements are also insufficient to render the claims patent-eligible because simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, has been held not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception.
Although claims 17-22 specify certain specific binding moieties or monoclonal antibodies and testing techniques used such as sandwich immunoassays or two-site immunometric assays including lateral flow assay and ELISA, such testing techniques were well-known, routine and conventional as evidenced by the instant specification, which states that such assays were described “standard techniques” that are “well-known to those skilled in the art” [0032-0036].
In addition to the evidence of the specification, Inohara et al. (Biochem. Biophys. Res. Comm. 376: 605-610 (Sep 2008)) teach a two-site monoclonal antibody-based ELISA method using a kit (MonoAb EIA Kit) for detecting a level of human galectin-3 in serum sample of a subject (Abstract). Iurisci et al. (Clin. Cancer Res. 6: 1389, 2000) teach a sandwich immune-ligand assay for galectin-3 in which solid-phase captured galectin-3 is determined indirectly using labeled rat mAb M3/38 monoclonal antibodies (p. 1390, cols 1-2). Therefore, prior to the time of the instant claimed invention, it was well-understood, routine and conventional to detect and measure human galectin-3 using sandwich ELISA. See also Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015):
Where claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter if the methods themselves are conventional, routine and well understood applications in the art.
When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or a transformation of a particular article, in such steps that distinguishes them from well-understood, routine, and conventional data gathering activity engaged in by scientists prior to applicant’s invention, and at the time the application was filed, e.g., the routine and conventional techniques of detecting a protein using an antibody to that protein. See also MPEP 2106.05(g). Further, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and detecting steps does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)).
The combination of steps recited in these process claims taken as a whole, including the well-understood, routine, and conventional steps of data acquisition recited with a high level of generality which would substantially foreclose others from using the naturally occurring correlation, or limitations of the use to a particular technological environment (field-of-use) (“Guidance”, I.B.1), are not sufficient to qualify as a patent-eligible practical application of a law of nature or of a naturally occurring correlation, i.e. of a natural principle, as the claims do not amount to significantly more than a statement of the natural principle with generalized directions to apply it to the relevant population. See Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289, 101 USPQ2d 1961 (2012).
Based upon this analysis of the claims as a whole, the claims do not recite something significantly different than a judicial exception and fail to include additional elements that are sufficient to amount to significantly more than the judicial exception(s).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
4. Claims 17-22 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Inohara et al. (Cytoplasmic and serum galectin-3 in diagnosis of thyroid malignancies. Biochem. Biophys. Res. Comm. 376: 605-610 (Sep 2008)) in view of Iurisci et al. (Concentrations of Galectin-3 in the Sera of Normal Controls and Cancer Patients. Clin. Cancer Res. 6: 1389 (2000) and in further view of Pinto (US Patent 7,888,137).
Inohara et al. teach a two-site monoclonal antibody-based ELISA method using a kit (MonoAb EIA Kit) for detecting a level (i.e. concentration) of human galectin-3 in serum sample of a subject (Abstract; p. 605, col. 2; Table 3). The method comprises obtaining a serum sample from a subject; contacting the sample with a monoclonal antibody: mAb 50A3 (i.e. first binding moiety) immobilized on a solid surface (coated on microtiter plate wells) that specifically binds to human galectin-3 to capture and form a first complex with galectin-3 present in the serum sample. The method further comprises contacting the first complex with monoclonal antibody: mAb 87B5 (i.e. second binding moiety) conjugated to a detectable enzyme label (horseradish peroxidase: HRP) that specifically binds to the galectin-3 in the first complex to form a labeled second complex; thereby forming a sandwich complex (p. 605, col. 2 to p. 606, col. 2). Inohara et al. teach detecting the enzyme label to obtain the level of human galectin-3 (i.e. quantitative) present in the serum sample (p. 605, col. 2 to p. 606, col. 1: Two-site MAb-based ELISA; p. 608). Inohara et al. teach that in contrast to mAb M3/38, the monoclonal antibodies of the reference bound to degenerated products of galectin-3 (p. 606, col. 2; Fig. 1A).
Inohara et al. generated anti-galectin-3 monoclonal antibodies designated as mAb 11A4, mAb 19E2, mAb 50A3, mAb 74E2, and mAb 87B5. To establish ELISA, Inohara et al. developed different combinations of monoclonal antibodies which were evaluated in their ability to quantify galectin-3; and indicated that mAb 50A3 and mAb 87B5 as well as mAb 87B5 and mAb 11A4 as catcher (solid phase capture) and detector (detectable label), respectively matched well. Inohara et al. selected mAb 50A3 as solid phase capture antibody and mAb 87B5 as enzyme label antibody for further study because of its increased specificity and because other monoclonal antibodies such as mAb 11A4 showed non-specific binding on immunoblotting (p. 606, col. 2 to 607; Table 1). The standard ELISA calibration curve for mAb 50A3 and mAb 87B5 is shown in Figure 1B; and quantitative results indicate levels of human galectin-3 above threshold galectin-3 concentrations in the range of 15-20 ng/ml or 20-25 ng/ml or 25-30 ng/ml or 30-35 ng/ml. The assay as taught by Inohara et al. provided readings in a standard curve in the range of 0.624 to 40 ng/ml (p. 607, cols. 1-2; Fig. 1B; Tables 1 & 3) for some samples over the thresholds, as instantly claimed (Table 1; p. 607, ¶ bridging cols. 1-2).
Inohara et al. also teach a kit comprising a monoclonal antibody immobilized on a solid surface (microtiter plate wells) that is capable of binding to and capturing human galectin-3; and mAb 87B5 (second binding moiety) conjugated to a HRP enzyme label that is capable of binding to and labeling galectin-3. The kit further comprises a human galectin-3 protein standard (purified recombinant galectin-3 standard) (p. 605, col. 2 to p. 606, col. 2). In particular, Inohara et al. teach that mAb M3/38 is a well-characterized anti-galectin-3 mAb for application with ELISA in detecting galectin-3 (i.e. as first binding moiety) concentrations.
Inohara et al. differ from the instant invention in failing to explicitly teach using M3/38 immobilized on solid phase for applications in the ELISA method.
Iurisci et al. teach a sandwich immunoligand assay for galectin-3 in which solid-phase captured galectin-3 is determined indirectly using labeled rat mAb M3/38 monoclonal antibodies (p. 1390, cols 1-2). The reference teaches that the epitope bound in the assay was detectable after long term storage and/or freeze-thaw cycles of serum samples (p. 1391, col. 1).
It would have been obvious to one of ordinary skill in the art at the time the instant invention was made to have substituted MAb M3/38 produced by Inohara and taught by both Inohara and Iurisci, as capture anti-galectin-3 monoclonal antibody because mAb m3/38 is well-known, conventional, and well-characterized for use with ELISA designed to detect the level of galectin-3 in serum, and because the Inohara reference itself stated that MAb M3/38 has been shown to function successfully in sandwich immune-ligand binding assays for galectin-3 determination.
It would have been further obvious to one of ordinary skill to have followed the guidance provided in the combined teachings of Inohara and Iurisci to determine optimal cut-off values as set forth in claims 17-21, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see In re Aller, 105 USPQ 233); and, discovering an optimum value of a result effective variable involves only routine skill in the art (see In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)). It would have been obvious to one of ordinary skill in the art at the time the instant invention was made that the combination of prior art elements according to notoriously old and well-known methods, and/ or substitution of one for another known alternative, as instantly claimed would have yielded predictable results because one would have expected each of the elements to perform their well-known functions in such a combination.
Inohara et al. and Iurisci et al. differ from the instant invention in failing to teach correlating galectin-3 concentrations to heart failure (HF).
Pinto teaches a method for identifying a subject at risk for heart failure (HF) comprising measuring the level of human galectin-3 in a plasma sample, and comparing the level to a reference standard (cols. 2-3; claims). The galectin-3 concentration levels were measured using ELISA and showed that levels in HF patients surpassed the upper limit of galectin-3 levels of healthy control subjects (col. 16; Tables 4-6).
It would have been obvious to one of ordinary skill in the art at the time the instant invention was made to have used the assay of Inohara as modified by Iurisci to monitor galectin-3 in the plasma of patients having or suspected of having or being at risk of HF as taught by Pinto because Pinto taught that increased circulating levels of galectin-3 is shown to be associated with HF. One of ordinary skill in the art at the time of the instant invention would have been motivated to use the method taught by Inohara as modified by Iurisci to diagnose HF in the method of Pinto because both of Inohara and Iurisci have shown that their methods are successful and effective in detecting accurate levels of galectin-3 which Pinto has shown to be a successful diagnostic marker for HF for patients suspected of having or being at risk of having HF.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
5. No claim is allowed.
Remarks
6. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Inohara et al. (JP 2004-198313-IDS) teach a method and kit for detection of human galectin-3 using two different monoclonal antibodies specific for two different epitopes of human galectin-3, one immobilized on a solid phase, one labeled (Abstract; Claims; [0011, 0023-0026, 0030, 0042-0045]) as an alternative to lengthy and low-throughput immunohistochemical and/or Western blotting methods known to the art [0004-0005]. The preferred pairs of antibodies were 50A3 and 87B5, or 87B5 and 11A4. The method detected levels in samples over various thresholds expressed as ng/ml ([0049]; Table 2).
Bender MedSystems (IDS) teach a monoclonal/polyclonal sandwich immunoassay for determination of galectin-3 with a limit of detection of less than 0.12 ng/ml.
Cherayil et al. (PNAS USA 87: 7324, 1990- IDS) teach the sequence of human galectin-3, as also compared to the mouse sequence, and teach the specificity of the M3/38 monoclonal antibody for human galectin-3 (pp. 7325-7326). The reference teaches the use of the antibody for investigations of the involvement of human galectin-3 in human disease states (p. 7327, col. 1).
Gray et al. (Arch. Biochem. Biophys. 475: 100, 2008- IDS) teach the epitope of galectin-3 inherently bound by the notoriously old and well-known M3/38 (ATCC TIB 166) anti-galectin-3 monoclonal antibody (p. 101, col. 1; p. 103, col. 2).
Hsu et al. (US 2002/0155513) teach the detection of galectin-3 in cancer patients.
Liu et al. (Biochem. 35: 6073, 1996- IDS) teach the elicitation of monoclonal antibodies specific for galectin-3 and teach that the N-terminus of the molecule comprises the immunologically dominant domain of the protein when used as an immunogen in mice because all of the isolated mouse monoclonal antibodies elicited to the intact recombinant protein bound to amino acid residues 1-45 (p. 6079; Table 1; Fig. 2).
Liu et al. (Am. J. Pathol. 147: 1016, 1995- IDS) in light of Liu et al. (Biochem. 35: 6073, 1996- IDS) teach an enzyme-linked immunosorbent assay for detection of galectin-3 in samples with immobilized polyclonal antibodies and labeled polyclonal antibodies (p. 1019). Recombinant galectin-3 was provided as a standard. The standard curve for the assay was linear from 1 ng/ml to 500 ng/ml. Inherently the polyclonal antibodies contained antibodies specific for immunogenic epitopes of galectin-3 including those in the N-terminal region of the protein, particularly in light of the teachings in Liu et al. (1996) that the N-terminus of the molecule comprises the immunologically dominant domain of the protein (p. 6079).
Liu et al. (US 2002/0044932) teach galectin-3 in inflammatory cells and the role of inflammatory cells in inflammatory injury occurring after reperfusion of ischemic tissue such as the heart [0050].
Nachtigal et al. (Am. J. Pathol. 152: 1199, 1998- IDS) provided samples from normal patients and patients with atherosclerosis and detected galectin-3 by immunohistochemical staining or Western blotting with the M3/38 monoclonal antibody specific for galectin-3.
Ohshima et al. (Arthritis Rheum. 48: 2788, 2003- IDS) teach sandwich immunoassays for determination of galectin-3.
Prolla et al. (US 7,041,449) teach detection or measurement of biomarkers in biological samples such as tissue samples, including heart, or in bodily fluids such as serum or plasma (cols. 4 and 7) to monitor treatments (col. 7) or disease states (col. 9). Nucleic acids encoding the biomarkers or biomarker proteins are detected. For detection of proteins, antibodies specific for the protein can be used in any suitable assay such as an ELISA, an immunohistochemical assay, or a proteomic assay such as mass spectroscopy (cols. 4 and 7). Analysis and presentation of results can be automated for example with software (col. 4). Kits for identification, characterization, and quantitation of the markers are provided, including kits containing antibodies specific for the markers, other reagents such as buffers and detection reagents, controls, and instructions (col. 7). A preferred biomarker for detection or measurement is galectin-3 (X16834) (cols. 8 and 14).
Rabinovich et al. (Biochimica et Biophys. Acta 1572: 274, 2002- IDS) teach the role of galectin-3 in inflammatory processes.
Woo (US 2002/0076738) teaches the detection of galectin-3 in the blood of cancer patients.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
November 12, 2025