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 .
Applicant’s arguments and amendments filed 7/28/2026 have been entered and carefully considered but are not completely persuasive.
The IDS statements filed 7/28/2026 and 8/4/2026 have been entered and considered.
The substitute specification filed 7/28/2026 has been entered.
Claims 68-71, 73, 74, 78-88, 90-91, 94-97 are pending and under examination.
Applicant previously elected, without traverse, Autism Spectrum Disorder (ASD) and the Core Features of Table 2, in the reply filed on 11/6/2025. The effective filing date for the pending claims appears to be 6/6/2019.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation (BRI) using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
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 68-71, 73, 74, 78-88, 90-91, 94-97 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of mental steps, mathematic concepts, organizing human activity, or a natural law without significantly more.
Applicant is directed to MPEP 2106 for the most current and complete guidelines in the analysis of patent- eligible subject matter. The current MPEP is the primary source for the USPTO’s patent eligibility guidance.
With respect to step (1): YES, the claims are drawn to statutory categories: Claims 68-71, 73, 74, 78-85 are drawn to methods. Claims 86-88, 90, 91, 94-96 are drawn to a device comprising processors and memory to carry out the methods and claim 97 is drawn to a non-transitory computer readable media comprising instructions.
With respect to step (2A) (1): YES, the claims recite an abstract idea, law of nature and/or natural phenomenon. The claims explicitly recite elements that, individually and in combination, constitute one or more judicial exceptions (JE).
Mathematic concepts, Mental Processes or Elements in Addition (EIA) in the claim(s) include:
68. (Currently amended) A method for evaluating a subject for a first biological condition associated with metal metabolism, wherein the first biological condition associated with metal metabolism is autism spectrum disorder (ASD), comprising:
(EIA: preamble setting forth a process, and the goal of the process: evaluating a subject.)
sampling each respective position in a plurality of positions along a reference line on a biological sample associated with metal metabolism of the subject, thereby obtaining a plurality of ion samples,
each ion sample in the plurality of ion samples corresponding to a different position in the plurality of positions, and
each position in the plurality of positions representing a different period of growth of the biological sample associated with metal metabolism;
wherein the biological sample associated with metal metabolism of the subject is the hair shaft, and
wherein the reference line corresponds to a longitudinal direction of the hair shaft;
(EIA- a step of necessary data gathering, performed on a hair sample, to obtain “ion samples” of any ion, by any means, and a description of the data gathered. MPEP 2106.05(e, g, h))
analyzing each ion sample in the plurality of ion samples with a mass spectrometer thereby obtaining a first dataset that includes a plurality of traces,
each trace in the plurality of traces being a concentration of a corresponding elemental isotope, in a plurality of elemental isotopes, over time collectively determined from the plurality of ion samples;
(EIA- a step of necessary data gathering, analyzing the sample using any type of mass spectrometry, and a description of the data gathered. MPEP 2106.05(e, g, h))
deriving a second dataset from the plurality of traces that includes a set of features,
each respective feature in the set of features being determined by a variation of a single isotope or a combination of isotopes in the plurality of traces; and
(Mathematic concept of making unspecified calculations, [0019, 0022, 0040, 0043, 0135, 0149] set forth some calculations and the removal of data that does not meet a criterion. MPEP 2106.04(a) subsection I)
computing, by a trained classifier, an indication as to whether the subject has the first biological condition associated with metal metabolism, based on the set of features.
(Mathematic concept of applying sample data to an unspecified “trained classifier” to identify the presence of a biological condition. No details on the type of classifier, classifier structure, training data, or how the training data affects the classifier to generate the desired results. [0022] sets forth one embodiment of the algorithm used by the classifier. [0027] addresses training. [0028] “trained classifier is a neural network algorithm, a support vector machine algorithm, a decision tree algorithm, an unsupervised clustering model algorithm, a supervised clustering model algorithm, or a regression model.” MPEP 2106.04(a)(2) subsection I)
69. (Currently amended) The method of claim 68, wherein the plurality of elemental isotopes is selected from Li-7 (Li), Mg-24 (Mg), Mg-25 (Mg25), Al-27 (Al), P-31 (P), S-34 (S), Ca-44 (Ca), Ca-43 (Ca43), Cr-52 (Cr), Mn-55 (Mn), Fe-56 (Fe), Co-59 (Co), Ni-60 (Ni), Cu-63 (Cu), Zn-66 (Zn), As-75 (As), Sr-88 (Sr), Cd-111 (Cd), Sn-118 (Sn), I-127 (I), Ba-138 (Ba), Hg-201 (Hg), Pb-208 (Pb), Bi-209 (Bi), and Mo-95(Mo).
(EIA- related to the data gathering steps)
70. (Previously Presented) The method of claim 68, wherein each feature in the set of features is associated with a single respective trace of the plurality of traces or with two respective traces of the plurality of traces.
(Mathematic concept modification, associating data gathered, with the derived features of the second dataset.)
71. (Currently amended) The method of claim 70, wherein the set of features is selected from Determinism_Cd, Determinism_Cr, Determinism_ZnHg, Determinism_Cu, Determinism_ZnMn, Determinism_Sr, Entropy_As, Determinism_Mg, Entropy_Li,Determinism_ZnCu, Entropy_ZnCu, MDL_ZnCu, Determinism_Ca, Determinism_Mn,Determinism_Ni, Determinism_ZnMg, Determinism_ZnCr, Determinism_Pb, Determinism_ZnNi, Determinism_ZnSn, Determinism_Li, Determinism_Hg,Determinism_Fe, Determinism_As, Determinism_ZnI, Determinism_Ba, Determinism_Ca,Determinism_Cr, Determinism_Cu, Determinism_Fe, Determinism_I, Determinism_Mg, Determinis_Mn, Determinism_P, Determinism_Pb, Determinism_S, Determinism_Sn,Determinism_Sr, Determinism_Zn, Determinism_ZnBa, Determinism_ZnCa,Determinism_ZnCr, Determinism_ZnCu, Determinism_ZnFe, Determinism_ZnI,Determinism_ZnMg, Determinism_ZnMn, Determinism_ZnP, Determinism_ZnPb,Determinism_ZnS, Determinism_ZnSn, Determinism_ZnSr, MDL_Ba, MDL_Ca, MDL_Cr, MDL_Cu, MDL_Fe, MDL_I, MDL_Mg, MDL_Mn, MDL_P, MDL_Pb, MDL_S, MDL_Sn,MDL_Sr, MDL_Zn, MDL_ZnBa, MDL_ZnCa, MDL_ZnCr, MDL_ZnCu, MDLZn_Fe,MDL_ZnI, MDL_ZnMg, MDL_ZnMn, MDL_ZnP, MDL_ZnPb, MDL_ZnS, MDL_ZnSn, MDL_ZnSr, Entropy_Ba, Entropy_Ca, Entropy_Cr, Entropy_Cu, Entropy_Fe, Entropy_I, Entropy_Mg, Entropy_Mn, Entropy_P, Entropy_Pb, Entropy_S Entropy_Sn, Entropy_Sr, Entropy_Zn, Entropy_ZnBa, Entropy_ZnCa, Entropy_ZnCr, Entropy_ZnCu, Entropy_ZnFe, Entropy_ZnI, Entropy_ZnMg, Entropy_ZnMn, Entropy_ZnP, Entropy_ZnPb, Entropy_ZnS,Entropy_ZnSn, Entropy_ZnSr, Laminarity_Ba, Laminarity_Ca, Laminarity_Cr, Laminarity_Cu, Laminarity_Fe, Laminarity_I, Laminarity_Mg, Laminarity_Mn, Laminarity_P, Laminarity_Pb, Laminarity_S, Laminarity_Sn, Laminarity_Sr, Laminarity_Zn, Laminarity_ZnBa, Laminarity_ZnCa, Laminarity_ZnCr, Laminarity_ZnCu, Laminarity_ZnFe, Laminarity_ZnI, Laminarity_ZnMg, Laminarity_ZnMn, Laminarity_ZnP, Laminarity_ZnPb, Laminarity_ZnS, Laminarity_ZnSn, Laminarity_ZnSr, TT_Ba, TT_Ca, TT_Cr, TT_Cu, TT_Fe, TT_I, TT_Mg, TT_Mn, TT_P, TT_Pb, TT_S, TT_Sn, TT_Sr, TT_Zn, TT_ZnBa, TT_ZnCa, TT_ZnCr, TT_ZnCu, TT_ZnFe, TT_ZnI, TT_ZnMg, TT_ZnMn, TT_ZnP, TT_ZnPb, TT_ZnS, TT_ZnSn, TT_ZnSr, RT2_Ba, RT2_Ca, RT2_Cr, RT2_Cu, RT2_Fe, RT2_I, RT2_Mg, RT2_Mn, RT2_P, RT2_Pb, RT2_S, RT2_Sn, RT2_Sr, RT2_Zn, RT2_ZnBa, RT2_ZnCa, RT2_ZnCr, RT2_ZnCu, RT2_ZnFe, RT2_ZnI, RT2_ZnMg, RT2_ZnMn, RT2_ZnP, RT2_ZnPb, RT2_ZnS, RT2_ZnSn, and RT2_ZnSr.
(Mathematic concept modification, specifying the features to keep in the second dataset.)
73. (Previously Presented) The method of claim 68, wherein evaluating the subject for a first biological condition associated with metal metabolism further includes discriminating between the first biological condition associated with metal metabolism and a second biological condition associated with metal metabolism distinct from the first biological condition associated with metal metabolism.
(Mental process of observing results for various conditions and making a judgement as to whether any apply to the sample from the subject.)
74. (Currently Amended) The method of claim 73, the second biological condition is attention- deficit/hyperactivity disorder.
(Mental process of observing results for various conditions and making a judgement as to whether any apply to the sample from the subject.)
78. (Previously Presented) The method of claim 68, further including pretreating the biological sample associated with metal metabolism of the subject with a solvent or a surfactant prior to the sampling. (EIA- related to data gathering, specifying the treatment of the sample to be analyzed.)
79. (Previously Presented) The method of claim 68, further including irradiating the biological sample associated with metal metabolism of the subject with a low powered laser to remove any debris from the biological sample associated with metal metabolism of the subject prior to the sampling. (EIA- related to data gathering, specifying the treatment of the sample to be analyzed.)
80. (Previously Presented) The method of claim 68, wherein the sampling includes irradiating, with a laser, the biological sample associated with metal metabolism of the subject, thereby extracting a plurality of particles from the biological sample associated with metal metabolism of the subject; and ionizing the plurality of particles with an inductively coupled plasma mass spectrometer, thereby obtaining the plurality of ion samples. (EIA- related to data gathering, specifying the treatment of the sample to be analyzed.)
81. (Previously Presented) The method of claim 68, wherein the plurality of positions is sequenced such that a first position in the plurality of positions along the biological sample associated with metal metabolism of the subject corresponds to a position closest to a tip of the biological sample associated with metal metabolism of the subject. (EIA- related to data gathering, specifying the treatment of the sample to be analyzed.)
82. (Previously Presented) The method of claim 68, wherein the concentration of the corresponding elemental isotope corresponds to a relative abundance of the corresponding elemental isotope to a control elemental isotope, the control elemental isotope included in the plurality of ion samples. (EIA- related to data gathering, specifying control ions are also analyzed.)
83. (Previously Presented) The method of claim 68, wherein the set of features is selected from the group consisting of a mean diagonal length, a determinism, a recurrence time, an entropy, a trapping time, and a laminarity. (Mathematic concept modification, identifying certain features to be calculated.)
84. (Previously Presented) The method of claim 68, wherein the biological condition associated with metal metabolism is related to a periodic dysregulation of metabolism of a plurality of metals, the plurality of metals corresponding to the plurality of elemental isotopes. (EIA- a description of “biological conditions” for which the sample is evaluated. Related to data gathering.)
85. (Previously Presented) The method of claim 68, wherein the indication is a probability that the subject has the first biological condition associated with metal metabolism. (Mathematic concept of calculating a probability value.)
86. (Currently amended) A device for evaluating a subject for a biological condition associated with metal metabolism, wherein the biological condition associated with metal metabolism is autism spectrum disorder (ASD), the device comprising one or more processors, and memory storing one or more programs for execution by the one or more processors, the one or more programs comprising instructions for:
(EIA- a generically stated device, comprising general-purpose processors, memory, and instructions. MPEP 2106.05(f))
The analysis of the method steps is the same as for claim 68.
87. See analysis of claim 85.
88. see analysis of claim 70.
90. See analysis of claim 73.
91. See analysis of claim 74.
94. See analysis of claim 78.
95. See analysis of claim 79.
96. See analysis of claim 82.
97. (Previously Presented) A non-transitory computer readable storage medium and one or more computer programs embedded therein for classification, the one or more computer programs comprising instructions which, when executed by a computer system, cause the computer system to perform a method of evaluating a subject for a biological condition associated with metal metabolism, wherein the biological condition associated with metal metabolism is autism spectrum disorder (ASD), the method comprising: [the method of claim 68].
(EIA- a generically described CRM, comprising programs and instructions. MPEP 2016.05(f).)
The remainder of the analysis is the same as for claim 68.
Natural Law: Claims 68-71, 73, 74, 78-88, 90-91, 94-97 recite a natural law.
The claims embrace the naturally occurring correlations between differences in naturally occurring ions in patient samples, and a naturally occurring phenotype of a disease of metal metabolism, where the disease is autism spectrum disorder (ASD). The correlation occurs in nature whether or not it is measured. The observation of the natural law is all that is required.
These meet at least the following examples identified by the Courts (MPEP 2106.04(b)):
“iv. a correlation that is the consequence of how a certain compound is metabolized by the body, Mayo Collaborative Servs. v. Prometheus Labs., 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012);”
“v. a correlation between the presence of myeloperoxidase in a bodily sample (such as blood or plasma) and cardiovascular disease risk, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017);”
“xi. the natural relationship between a patient’s CYP2D6 metabolizer genotype and the risk that the patient will suffer QTc prolongation after administration of a medication called iloperidone, Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117, 1135-36, 126 USPQ2d 1266, 1281 (Fed. Cir. 2018)”
With respect to step 2A (2): NO, the claims do not integrate the JE into a practical application (MPEP 2106.04(d)):
“Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I supra, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h).”
Claim(s) 68, 69, 78-82, 84, 86, 92-97 each recite the additional non-abstract element(s) of data gathering, or a description of the data gathered.
Data gathering steps are not an abstract idea, they are extra-solution activity, as they collect the data necessary to carry out the JE. MPEP 2106.05(g).
The data gathering does not impose any meaningful limitation on the JE, or how the JE is performed. MPEP 2106.05(g).
The data gathering steps constitute a general link to a technological environment: mass spectrometry. (MPEP 2106.05(h), citing Mayo, Bilski, electric Power Group, Genetic Techs Ltd v Merial LLC.)
The additional limitation (data gathering) must have more than a nominal or insignificant relationship to the identified judicial exception to provide integration into a practical application. (MPEP 2106.05(g) citing Mayo, PerkinElmer, Inc. v. Interna Ltd, Intellectual Ventures LLC v. Erie Indem. Co., Electric Power Group LLC v. Alstom S.A.).
Claim(s) 86, 97 recite the additional non-abstract element (EIA) of a general-purpose computer system or parts thereof.
The claims do not provide any details of how specific structures of the computer elements are used to implement the JE. MPEP 2106.05(a), contrasting decisions identifying how the computer implements an abstract idea, such as in McRo to decisions which found no specific interaction with the computer, such as in Affinity Labs of Tex v. DirecTV, LLC.
The computer elements of the claims do not provide improvements to the functioning of the computer itself. MPEP 2106.05(a) I, contrasting decisions indicating an improvement to the computer, such as DDR Holdings, LLC v. Hotels.com LP, with decisions that did not identify an improvement to the computer, such as FairWarning IP, LLC v. Iatrix Sys.
The computer elements of the claims do not provide improvements to any other technology or technical field. MPEP 2106.05(a) II: contrasting decisions indicating an improvement to the technology, such as Diamond v. Diehr, Trading Techs. Int’l v. CQG Inc, or Intellectual Ventures I v. Symantec Corp, with decisions that did not identify an improvement to the technology, such as Alice Corp, Versata Dev. Group, Inc. v. SAP AM. Inc, or TLI Communications.
The computer elements of the claims do not utilize a particular machine. MPEP 2106.05(b): contrasting decisions wherein a particular machine was identified, such as MacKay Radio & Tel. Co. v. Radio Corp. of America, Eibel Process Co. v. Minn. & Ont. Paper Co., with decisions where a general-purpose computer does not qualify as a particular machine, such as Ultramercial, Inc. v. Hulu, LLC, TLI communications, or Eon Corp. IP holdings LLC v. AT&T Mobility LLC.
Hence, these are mere instructions to apply the JE using a computer, and therefore the claim does not recite integrate that JE into a practical application.
Dependent claim(s) 70, 71, 73, 74, 83, 85, 87-88, 90 and 91 recite(s) an abstract limitation to the JE reciting additional mathematic concepts, or mental processes. Additional abstract limitations cannot provide a practical application of the JE as they are a part of that JE.
In combination, the limitations of data gathering, for the purpose of carrying out the JE, using a general-purpose computer merely provide extra-solution activity, and fail to integrate the JE into a practical application.
With respect to step 2B: NO, the claims do not recite a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05).
“… an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself. Alice Corp…”
With respect to claim(s) 68, 69, 78-82, 84, 86, 92-97: The limitation(s) identified above as non-abstract elements (EIA) related to data gathering do not rise to the level of significantly more than the judicial exception.
Ash (2018; of record) obtains a hair sample, samples positions along the hair, along the direction of growth over time, obtains traces by carrying out mass spectrometry, and obtains features related to thallium, and lead ions.
Sela (2007) obtains hair samples, samples position along the hair in the direction of growth and obtains traces using mass spectrometry. Features related to uranium. Sela et al (2007) Biomonitoring of hair samples by laser ablation inductively coupled plasma mass spectrometry (LA-ICP-MS). International Journal of Mass Spectrometry, vol 261, p199-207.
Tinkov (January, 2019) obtains hair samples, takes samples longitudinally, and obtains traces using ICP-MS, features related to Ca, Se, Hg, I, Mn, AI, Cd, etc.
Pozebon et al. (2008; PTO-1449) obtains hair samples, sample positions along the hair, in the direction of growth, obtain traces by carrying out mass spectrometry, and obtain features related to Pt and S ions.
Pozebon (2017; PTO-1449) discusses at length the analysis of hair samples by MS, along the direction of growth by mass spectrometry, for identifying features related to various ions, and elements of interest. Details as to pretreatment are also provided.
These elements meet the BRI of the identified data gathering limitations. As such, the prior art recognizes that this data gathering element is routine, well understood and conventional in the art. MPEP 2106.05(d): “If, however, the additional element (or combination of elements) is no more than well-understood, routine, conventional activities previously known to the industry, which is recited at a high level of generality, then this consideration does not favor eligibility.”
Data gathering steps are not an abstract idea, they are extra-solution activity, as they collect the data necessary to carry out the JE. MPEP 2106.05(g).
The data gathering does not impose any meaningful limitation on the JE, or how the JE is performed. MPEP 2106.05(g).
The additional limitation (data gathering) must have more than a nominal or insignificant relationship to the identified judicial exception to provide an inventive concept. (MPEP 2106.05(g) citing Mayo, PerkinElmer, Inc. v. Interna Ltd, Intellectual Ventures LLC v. Erie Indem. Co., Electric Power Group LLC v. Alstom S.A.)
The data gathering steps constitute a general link to a technological environment: the trait prediction methods are intended to be applied to plant populations. (MPEP 2106.05(h), citing Mayo, Bilski, electric Power Group, Genetic Techs Ltd v Merial LLC.)
Therefore, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception are insufficient to provide significantly more (as discussed in Alice Corp.,).
With respect to claim(s) 86, 97: the limitations identified above as non-abstract elements (EIA) related to general-purpose computer systems do not rise to the level of significantly more than the judicial exception.
Each of Ash, Sela, Tinkov, Pozebon (2008), Pozebon (2017) disclose computer systems or computing elements which meet the BRI of the claimed computer system or computer system elements, comprising input, output/ display, a processor, and memory.
As such, the prior art recognizes that these computing elements are routine, well understood and conventional in the art.
The specification, at [0091-0094] discloses the use of routine general-purpose computers for carrying out the invention, and/or the use of commercially available computer system elements.
The claims do not provide any details of how specific structures of the computer elements are used to implement the JE. MPEP 2106.05(a), contrasting decisions identifying how the computer implements an abstract idea, such as in McRo to decisions which found no specific interaction with the computer, such as in Affinity Labs of Tex v. DirecTV, LLC.
The computer elements of the claims do not provide improvements to the functioning of the computer itself. MPEP 2106.05(a) I, contrasting decisions indicating an improvement to the computer, such as DDR Holdings, LLC v. Hotels.com LP, with decisions that did not identify an improvement to the computer, such as FairWarning IP, LLC v. Iatrix Sys.
The computer elements of the claims do not provide improvements to any other technology or technical field. MPEP 2106.05(a) II: contrasting decisions indicating an improvement to the technology, such as Diamond v. Diehr, Trading Techs. Int’l v. CQG Inc, or Intellectual Ventures I v. Symantec Corp, with decisions that did not identify an improvement to the technology, such as Alice Corp, Versata Dev. Group, Inc. v. SAP AM. Inc, or TLI Communications.
The computer elements of the claims do not utilize a particular machine. MPEP 2106.05(b): contrasting decisions wherein a particular machine was identified, such as MacKay Radio & Tel. Co. v. Radio Corp. of America, Eibel Process Co. v. Minn. & Ont. Paper Co., with decisions where a general-purpose computer does not qualify as a particular machine, such as Ultramercial, Inc. v. Hulu, LLC, TLI communications, or Eon Corp. IP holdings LLC v. AT&T Mobility LLC.
Hence, these are mere instructions to apply the JE using a computer, and therefore the claim does not provide significantly more.
Dependent claim(s) 70, 71, 73, 74, 83, 85, 87-88, 90 and 91 each recite a limitation requiring additional mathematic concepts or mental processes. Additional abstract limitations cannot provide significantly more than the JE as they are a part of that JE (MPEP 2106.05).
In combination, the data gathering steps providing the information required to be acted upon by the JE, performed in a generic computer or generic computing environment fail to rise to the level of significantly more than that JE. The data gathering steps provide the data for the JE, which is carried out by the general-purpose computers. No non-routine step or element has clearly been identified.
The claims have all been examined to identify the presence of one or more judicial exceptions. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether the additional limitations integrate the judicial exception into a practical application. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether those additional limitations provide an inventive concept which provides significantly more than those exceptions. For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Applicant’s arguments:
Applicant’s arguments have been carefully considered but are not persuasive.
Applicant argues the categorization or identification of abstract ideas, and/or a natural law in the claims. The Examiner has specifically identified each limitation in the claim, and what category of judicial exception is encompassed. The abstract ideas identified in the independent claims are the same as those identified as mathematic correlations, mathematic calculations, and mathematical relationships or as mental processes, concepts performed in the human mind including observations, evaluations, judgements and opinions, in MPEP 2106.04.
The examiner acknowledges Applicant’s arguments which set forth that the claims lead to an improvement in the evaluation of a subject for ASD. According to the guidance set forth in MPEP 2106, this is an improvement to the judicial exception itself and is not reflected back into a specific technological environment or practically applied process.
An improvement in the judicial exception itself is not an improvement in the technology. For example, in In re Board of Trustees of Leland Stanford Junior University, 989 F.3d 1367, 1370, 1373 (Fed. Cir. 2021) (Stanford I), Applicant argued that the claimed process was an improvement over prior processes because it ‘‘yields a greater number of haplotype phase predictions,’’ but the Court found it was not ‘‘an improved technological process’’ and instead was an improved ‘‘mathematical process.’’ The court explained that such claims were directed to an abstract idea because they describe ‘‘mathematically calculating alleles’ haplotype phase,’’ like the ‘‘mathematical algorithms for performing calculations’’ in prior cases. Notably, the Federal Circuit found that the claims did not reflect an improvement to a technological process, which would render the claims eligible (FR89 no.137, p58137, 7/17/2024).
Here, Applicant has provided an improved mathematical process of analyzing MS trace data for differences in metal metabolism, which are then used in the improved mathematical process to classify the results and provide an indication of +/- ASD.
The improvement in the analysis of the MS data (carried out by the judicial exception) does not provide an improvement in the technology of obtaining the hair samples; or the technology of use of mass spectrometry to measure the heavy/toxic metal data. The collection of the sample, and carrying out MS on the sample is carried out, unchanged, whether or not the judicial exception is applied. (Cleveland Clinic Foundation: using well-known or standard laboratory techniques is not sufficient to show an improvement (MPEP2106.05(a)).
The improvement in the analysis of the MS data (achieved by the judicial exception) does not require a non-conventional interaction with a specific element of a computer as was required in Enfish. The disputed claims in Enfish were patent-eligible because they were "directed to a specific improvement to the way computers operate, embodied in [a] self-referential table." Enfish, 822 F.3d at 1336. The court found that the "plain focus of the claims" there was on an improvement to computer functionality itself-a self-referential table for a computer database, designed to improve the way a computer carries out its basic functions of storing and retrieving data- not on a task for which a computer is used in its ordinary capacity. Id. at 1335-36. The court noted that the specification identified additional benefits conferred by the self-referential table (e.g., increased flexibility, faster search times, and smaller memory requirements), which further supported the court's conclusion that the claims were directed to an improvement of an existing technology. Id. at 1337 (citation omitted).
The improvement in the analysis of the MS data (carried out by the judicial exception) does not improve the functionality of the computer itself as in Finjan, Visual Memory, or SRI Int’l. In Finjan, claims to virus scanning were found to be an improvement in computer technology. In Visual Memory, claims to an enhanced computer memory system were found to be directed to an improvement in computer capabilities. In SRI Int'l, claims to detecting suspicious activity by using network monitors and analyzing network packets were found to be an improvement in computer network technology.
The improvement in the analysis of the MS data does not provide an improvement in computer animation and use rules to automate a subjective task of humans to create a sequence of synchronized, animated characters as in McRo. In McRO, it was not the mere presence of unconventional rules that led to patent eligibility. In McRO, "[t]he claimed improvement was to how the physical display operated (to produce better quality images)." SAP Am. v. InvestPic, LLC, 898 F.3d 1161, 1167 (Fed. Cir. 2018). The claims in McRO recited a step of applying the data sets generated using the specific claimed rules to a sequence of animated characters to produce lip synchronization and facial expression control of those animated characters. McRO, 837 F.3d at 1308. Thus, the claims were directed to an improvement in computer animation and used rules to automate a subjective task of humans to create a sequence of synchronized, animated characters. Id. at 1314--15.
In the claims at issue here, there is no such application of specifically claimed rules to produce an improved technological result. The process of analyzing the MS data is not a technological process; it is information evaluation.
With respect to the identified elements in addition (EIA) to the JE, each has been addressed above.
In the claims, the EIA identified as data gathering steps do not affect how the steps of the abstract idea are performed, they provide the data which is acted upon by the limitations of the JE. These data gathering steps do not apply, rely on, or use the steps identified as making up the JE. Rather, the mathematic calculation steps avail themselves of the data gathered. The data gathering in the claims constitutes insignificant pre-solution activity. See MPEP § 2106.05(g):
MPEP2106.05(g). “The term "extra-solution activity” can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim...”
“An example of pre-solution activity is a step of gathering data for use in a claimed process, e.g., a step of obtaining information about credit card transactions, which is recited as part of a claimed process of analyzing and manipulating the gathered information by a series of steps in order to detect whether the transactions were fraudulent.”
See also CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372 (Fed. Cir. 2011) ("[E]ven if some physical steps are required to obtain information from the database ... such data-gathering steps cannot alone confer patentability.").
The listed claims set forth the element in addition (EIA) to the JE of a computing system. The computing system limitations are recited at such a high level of generality, they can be met by a general-purpose computer system and are not considered a particular machine or manufacture integral to the claim (MPEP 2106.05(b)). Routine computer elements acting upon the data in a manner consistent to and according to their design are not considered to be sufficient to provide eligibility. (see, for example MPEP 2106.04(d): Gottschalk v. Benson “‘held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle.”)
Claims that recite performing information analysis (e.g., performing state estimate calculations, iteratively), as well as the collection and manipulation of information related to such analysis, have been determined by our reviewing court to be an abstract concept that is not patent eligible. See SAP, 898 F.3d, 1165, 1167, 1168 (Claims reciting "[a] method for providing statistical analysis" (id. at 1165) were determined to be "directed to an abstract idea" (id. at 1168)); see also Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat'l Ass 'n, 776 F.3d 1343, 1345, 1347 (Fed. Cir. 2014) (finding the "claims generally recite ... extracting data ... [and] recognizing specific information from the extracted data" and that the "claims are drawn to the basic concept of data recognition").
"As many cases make clear, even if a process of collecting and analyzing information is limited to particular content or a particular source, that limitation does not make the collection and analysis other than abstract." SAP, 898 F.3d at 1168 (internal quotation marks omitted)).
Step 2B requires that we look to whether the claim "adds a specific limitation beyond the judicial exception that [is] not 'well-understood, routine, conventional' in the field." Guidance 89 Fed. Reg. at 58133 (emphasis added); MPEP § 2106.05(d); see BSG TechLLCv. BuySeasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018).
The EIA identified as data gathering were shown, by citation of prior art references, and by citation in the specification, to be well-understood, routine, and conventional limitations in mass spectrometry.
The EIA identified as computer system related were shown, by citation of prior art references, and by reference to the specification, to be well-understood, routine and conventional computer elements.
In light of the foregoing, we conclude that the claims are directed to no more than judicial exceptions to Section 101 and do not recite the "significantly more" requisite to transform the nature of the claim into a patent-eligible application.
Further, with respect to the arguments regarding the alleged improvement, it is unclear that the independent claims recite all the necessary and sufficient steps required to achieve that improvement. MPEP 2106.05(a): “An important consideration in determining whether a claim improves technology is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome. McRO, 837 F.3d at 1314-15, 120 USPQ2d at 1102- 03; DDR Holdings, 773F.3d at 1259, 113 USPQ2d at 1107.”
The MPEP sets forth that “if the examiner concludes the disclosed invention does not improve technology, the burden shifts to applicant to provide persuasive arguments supported by any necessary evidence to demonstrate that one of ordinary skill in the art would understand that the disclosed invention improves technology. Any such evidence submitted under 37 CFR 1.132 must establish what the specification would convey to one of ordinary skill in the art and cannot be used to supplement the specification.” Applicant’s arguments cannot take the place of evidence.
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.
Claims 68-71, 73, 74, 78-88, 90-91, 94-97 remain 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.
The metes and bounds of the specific features to be identified in claim 68 are unclear. The claim fails to particularly point out and distinctly claim the particular features for each metal ion that are to be determined from each trace for any disorder or biological condition. It is unclear if these are the same features as listed in the tables in dependent claims, where certain types of features for specific metals are set forth. It is further unclear how many of each element in each table must be tested or represented to make each evaluation. It is unclear if only a few element values from the table, or the Entire set of values are required to make a valid and statistically significant evaluation or discrimination.
The metes and bounds of the term “deriving a second dataset… by a variation of a single isotope or a combination of isotopes” in claim 68 are unclear. The claim fails to particularly point out and distinctly claim how the derivation is to be carried out, and what isotopes to analyze and what differences in the traces provide the required “variation”. It is unclear what the second dataset actually comprises, in terms of the particular data, or data structure. This limitation is written in results-based language without any specifics as to how the result is to be achieved.
Further in claim 68, the metes and bounds of “computing, by a trained classifier, an indication…” are entirely unclear. The claim fails to particularly point out and distinctly claim a type of classifier, the structure of the classifier, how the classifier was trained, and how the trained classifier acts on the “second dataset” to achieve the desired result of “the indication as to whether the subject has the first biological condition…” It is entirely unclear what classifiers are suitable for this step, and it is similarly unclear how to train any classifier such that it is able to make any evaluations, diagnoses or provide any specific indications. This limitation is written in results-based language without any specifics as to how the result is to be achieved.
With respect to claims 73-74, the claim fails to particularly point out and distinctly claim how the discrimination between biological conditions is to be carried out with the information at hand from carrying out the method of claim 68. Claim 68 does not provide information specific to any particular biological condition, nor does it specifically collect information applicable to more than one biological condition. It is entirely unclear how the conditions are to be discriminated between. This limitation is written in results-based language without any specifics as to how the result is to be achieved.
With respect to claim 84, the claim fails to particularly point out and distinctly claim how any condition is determined to be “associated with metal metabolism… related to a periodic dysregulation of metabolism…” with respect to the data at hand from claim 68. Claim 68 does not clearly provide any of the information required to make any such determination, nor does the claim provide how a “periodic dysregulation” is to be recognized, determined, or identified. This limitation is written in results-based language without any specifics as to how the result is to be achieved.
With respect to claim 85, the claim fails to particularly point out and distinctly claim how the probability is determined given the data at hand from claim 68. The data resulting from claim 68 is a set of traces, and not a set of numbers which could clearly and unambiguously be used to calculate a percentage or probability. This limitation is written in results-based language without any specifics as to how the result is to be achieved.
While the claims are read in light of the specification, limitations from the specification cannot be read into the claims.
All of the above rejections equally apply to claims 86-97.
Applicant’s arguments:
Applicant’s arguments and amendments have been carefully considered but are not completely persuasive.
MPEP 2173: “The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what the inventor or a joint inventor regards as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph with respect to the claimed invention.”
The Examiner has identified multiple instances of indefiniteness remaining in the claims or introduced by amendment.
“The essential inquiry pertaining to this requirement is whether the claims set out and circumscribe a particular subject matter with a reasonable degree of clarity and particularity. "As the statutory language of ‘particular[ity]' and 'distinct[ness]' indicates, claims are required to be cast in clear—as opposed to ambiguous, vague, indefinite—terms. It is the claims that notify the public of what is within the protections of the patent, and what is not." Packard, 751 F.3d at 1313, 110 USPQ2d at 1788.”
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 68-70, 78, 80-82, 86, 88, 94, 96-97 remain rejected under 35 U.S.C. 102a1 as being anticipated by Blaurock-Busch (2011).
Blaurock-Busch (BB) et al. (2011) Heavy metals and trace elements in hair and urine of a sample of Arab children with autistic spectrum disorder. Maedica, vol 6 no 4, p247-258.
BB evaluates samples from subjects for ASD, a biological condition associated with metal metabolism.
(Abstract: “The purpose of this study is to examine possible environmental risk factors and sources of exposure to mercury and other heavy metals in children with autism spectrum disorder versus controls. … (i.e. hair analysis measurements reflect past exposure) … By assessing a spectrum of trace elements and heavy metals in hair and urine of both autistic and control groups…”).
BB utilizes ICP-MS to analyze samples.
(Abstract: “Hair and baseline urine samples (i.e. unprovoked urine) were taken from both groups and sent to the German clinical and environmental laboratory Micro Trace Minerals Gmbh, for the detection of heavy metals and trace elements levels where metal testing was performed via ICP-MS spectroscopy utilizing cell technique.”)
BB obtains hair samples from the subjects (p250). The hair samples were treated with detergent prior to analysis. Positions along the hair were analyzed to obtain ion samples. The ion samples were analyzed by ICP-MS to obtain a plurality of traces (P250).
“Samples were collected from the Autistic Spectrum Disorder (ASD) group and the control group. We took hair samples close to scalp from the occipital area for testing, and 10ml of each baseline urine sample. All samples were shipped to Micro Trace Minerals laboratory in Germany were the analysis was performed, following standard analytical procedures. Before testing, samples were repeatedly washed in the laboratory with a de-ionized detergent, rinsed 3 times with de-ionized water and dried in a specially-designated oven before weighing. For sample digestion, certified metal-free adds were used. Digestion took place in a closed-vessel microwave digestion system. Ultrapure water was used for final sample dilution and the analysis was performed via inductively coupled plasma with mass spectrometry (ICP-MS) utilizing collision/reaction cell methods coupled with ion-molecule chemistry, a reliable new method for interference reduction. Certified hair standards and in-house standards were used as part of the laboratory quality control and for the validation of results. Test values were reported in mg/kg (mcg/g).”
A dataset derived from the traces is obtained, and applied to a trained classifier, to generate a determination (p250-251).
“Statistical evaluation of data included a comparison of test values to existing reference ranges for children as reported by the Umweltbundesamt Germany (Environmental Protection Agency). For those metals for which no official reference ranges exist, statistical ranges were established by following standard laboratory procedures. All test data was converted and manipulated by using Spss software program version 17.0. Data was analyzed, mean and standard deviation was estimated as regarding age, developmental mile stones and heavy metal and trace elements levels either in hair or urine comparing the ASD group with controls. The t test was applied and p value was established to determine the statistically significant difference between the two groups.”
Tables 4 and 5 indicate the metal ion or trace metal tested, the value in the test and control population, and the p value. Tables 4 and 5 provide metal ion concentration for a plurality of ion samples, for the hair samples tested, for patient and control groups. This meets the BRI of the “analyzing each ion sample… obtaining a first dataset that includes a plurality of traces… being a concentration…” The heavy metals analyzed in Tables 4 and 5 meet the plurality of ions as recited.
BB derives a second dataset that includes a set of features, which are variations of one or more isotopes. Discriminatory values between ASD and controls for heavy metal exposure were found for arsenic, cadmium, barium, cesium, lead, magnesium, lithium, zinc, and iron. P251-252:
“There were statistically significant differences in the mean hair levels of arsenic, cadmium, barium, cerium and lead (p=0.01, 0.03, 0.003, 0.003, and 0.03 respectively) … There were statistically significant differences in the mean hair levels of magnesium and zinc (p=0.001 and 0.003 respectively).”
The data were computed to provide an indication of ASD, based on the features. P254. This meets the BRI of the “computing” limitation of the independent claims.
“Our findings indicate a significant differences between autistic and control children in the mean hair levels of arsenic, cadmium, barium, cerium and lead (p=0.01, 0.03, 0.003, 0.0031 and 0.03 respectively).” P254.
BB uses computers, comprising computer programs such as SPSS, meeting claims 86 and 97.
With respect to claim 69, at least one of the newly listed elements are identified by BB in Tables 4 and 5. Claim 69 does not set forth how many elements of the list are required for the “plurality”, as the “plurality of elemental isotopes is selected from…” which fails to identify how many are necessary and sufficient.
With respect to claim 70, and claim 88, LCP-MS provides a trace for each detected ion.
With respect to claim 78, and claim 94, BB washes the hair with detergent prior to sampling.
With respect to claim 81, the tip of the hair is included.
With respect to claim 82, and claim 96, control levels of isotopes are provided in tables 4 and 5.
Applicant’s arguments:
Applicant’s arguments have been considered but are not persuasive. BB teaches the broadest reasonable interpretation of the limitations of the amended claims as set forth above. The set of ions to be analyzed, the differences that indicate a diagnosis of ASD, how the classifier works on the analyzed data are all generically stated, and broadly described. Should the independent claims be amended to address a particular pattern that indicates ASD, this rejection may be overcome.
New Grounds of Rejection:
Claim(s) 68-70, 78, 82, 86, 88, 94, 96-97 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Tinkov et al. (2019).
Tinkov et al. (January, 2019) Association between catatonia and levels of hair and serum trace elements and minerals in autism spectrum disorder. Biomedicine & Biopharmacology, vol 109, p174-180.
Tinkov is directed to evaluating a subject for ASD and an associated condition of ASD (catatonia), using hair samples, and analyzing them by ICP-MS. (Abstract)
“The objective of the study was to investigate the association between catatonia in autism spectrum disorder (ASD) and the levels of hair and serum trace elements and minerals in children with ASD. The levels of hair and serum trace elements and minerals of boys suffering from ASD with (n = 30) and without (n = 30) catatonia, as well as 30 age- and sex-matched neurotypical controls were assessed using ICP-MS.”
With respect to claims 68, 86 and 97: Tinkov obtains hair samples and analyzes positions along the hair as set forth at p175. Washed hair samples were obtained from all children.
“Only proximal parts of occipital scalp hair strands were collected using ethanol-precleaned stainless steel scissors in a quantity of 0.05-0.1 g. The samples were washed with acetone, rinsed three times with double distilled water and dried on air at 60 ·c to a stable weight.” P175
Tinkov analyzes each sample to obtain ion traces for a variety of metals using mass spectrometry. P175-176. The metals analyzed by Tinkov meet the BRI of the plurality of ion samples and the plurality of traces. The independent claims do not set forth particular ions.
“The resulting samples were used for analysis of toxic (Al, As, Cd, Hg, and nickel (Ni)) and essential trace elements and minerals (Ca, cobalt (Co), chromium (Cr), Cu, Fe, iodium (I), magnesium (Mg), Mn, Se, vanadium (V), and Zn) with inductively-coupled plasma mass spectrometry at NexION 300D (PerkinElmer Inc., Shelton, CT 06484, USA) equipped with ESI SC-2 DX4 autosampler (Elemental Scientific Inc., Omaha, NE 68122, USA). Dynamic reaction cell (DRC) mode was enabled for analysis of certain elements, allowing reducing major atomic interferences.”
“Laboratory quality control was regularly performed before and after each set of analyses using analysis of the certified reference materials (CRM) of human hair GBW09101 (Shanghai Institute of Nuclear Research, Shanghai, China).” P176
Tinkov derives a second dataset that includes features by the variation of one or more isotopes as set forth at Tables 2 and 3.
“The obtained data were processed using Statistica 10.0 (StatSoft, Tulsa, OK, USA) software. Normality of data distribution was assessed using the Shapiro-Wilk test. As the distribution of data was not Gaussian, descriptive statistics of hair elements content included median and the respective 25 and 75 percentile boundaries. Nonparametric Mann-Whitney U test was used for group comparisons. Correlation analysis was performed using Pearson's correlation coefficient (r).” p176
Tinkov applies the data to a classifier as set forth at page 176 to provide an indication of catatonia or ASD. Tinkov discloses computers and software as set forth above. As such, claims 68, 86 and 97 are anticipated. See also Tables 4 and 5 and their description.
“Multiple regression analysis of the association between trace element levels and catatonia was performed. Particularly, Crude model (Model 1) included only trace elements characterized by significant group difference as independent predictors. Adjusted model (Model 2) was adjusted for the age of examinees, as well as clinical variables (speech delay, cognitive deficit, infantile psychosis, and hyperkinetic syndrome). Obsessive-compulsive syndrome was not included as a covariate as no variability was observed (0% prevalence in all groups). Two types of dependent variables were used including the presence of catatonia ("0" -- no catatonia, "1" -- catatonia, with "0" including both controls and patients with ASD without catatonia) and catatonia in ASD patients ("0" -- controls, "1" -- ASD children without catatonia, "2" - children suffering from ASD with catatonia). The level of significance was set as p < 0.05 for all analyses.”
With respect to claim 69-70, the ions/ isotopes analyzed by Tinkov are disclosed at Tables 2-5, and include more than one of the elements disclosed in claim 69.
With respect to claim 78 and 94, the hair samples were washed with shampoo, acetone and water as set forth above. P175
With respect to claims 82 and 96, control isotopes are included as set forth above. P175-176.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim s 68-71, 73, 74, 78-88, 90-91, 94-97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 131, 133, 137-138, 141, 151, 153, 155-168 of copending Application No. 18/248,138 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘138 is a species of the generic claims of this application, using LA-ICP-MS on hair samples, over a period of time before and after an intervention, to analyze elements present in the hair, including metal ions/isotopes. The traces of the ions by LA-ICP-MS are applied to classifiers to determine or evaluate the presence of a biological condition related to the metals. New claim 168 of the ‘138 application is drawn to a method of monitoring environmental exposure to heavy metals, by measuring heavy metal content of a hair sample along a reference line of the hair which falls within the scope of the independent claims of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 MARY K ZEMAN whose telephone number is 5712720723. The examiner can normally be reached on 8am-2pm M-F. Email may be sent to mary.zeman@uspto.gov if the appropriate permissions have been filed.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry Riggs can be reached on 571 270-3062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY K ZEMAN/ Primary Examiner, Art Unit 1686
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