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 election without traverse of Autism Spectrum Disorder (ASD) and the Core Features of Table 2 in the reply filed on 11/6/2025 is acknowledged.
Claims 68-97 are under examination to the extent they read upon the elected invention.
This application is a National Stage Application, filed under 371 of PCT/ US20/ 36368, filed 6/5/2020 and claims priority to US provisional application 62/858,260, filed 6/6/2019.
The 6/6/2019 date is the effective filing date for the generic pending claims 68-70, 75-83, 85-89, 92-97 for the evaluation for autism spectrum disorder. The provisional application does not provide basis for identifying any other disorder, or discriminating any other disorder from the first disorder of ASD, as only the table reciting the features of ASD is present in the provisional (Table 4). No features for any other disorder are specifically provided. The effective filing dates for claims 71-74, 84, 90-91 is 6/5/2020.
The examiner has reviewed all PCT related papers and filings.
The information disclosure statements filed 7/18/2025 and 11/12/2025 fail to comply with the provisions of 37 CFR 1.98(a)(4) because it/ they lack(s) the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
The drawings as filed are suitable for examination.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See, for example, [0004], p2.
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 68-97 is/are 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 and the Federal Register notice (FR89, no 137 (7/17/2024) p 58128-58138) 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: Processes.
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). MPEP 2106.04
Mathematic concepts, Mental Processes or Elements in Addition (EIA) in the claim(s) include:
68. (Previously Presented) A method for evaluating a subject for a first biological condition associated with metal metabolism 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;
(EIA- a step of necessary data gathering, performed on any biological 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) subsection I)
69. (Previously Presented) The method of claim 68, wherein the plurality of elemental isotopes is selected from the elemental isotopes listed in Table 1.
(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. (Previously Presented) The method of claim 70, wherein the set of features is selected from the features listed in Table 2, 3, 4, 5, 6, 7, 8, 9, or 10.
(Mathematic concept modification, specifying the features to keep in the second dataset.)
72. (Currently Amended) The method of claim 68, wherein the first biological condition associated with metal metabolism is selected from the group consisting of autism spectrum disorder (ADS), attention-deficit/hyperactivity disorder (ADHD), amyotrophic lateral sclerosis (ALS), schizophrenia, irritable bowel disease (IBD), pediatric kidney transplant rejection, and pediatric cancer.
(EIA- a description of “biological conditions” for which the sample is evaluated. Related to data gathering.)
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. (Previously Presented) The method of claim 73, wherein the first biological condition is autism spectrum disorder and 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.)
75. (Previously Presented) The method of claim 68, wherein the biological sample associated with metal metabolism of the subject is selected from the group consisting of a hair shaft, a tooth, and a nail.
(EIA- related to data gathering, specifying the type of sample to be analyzed.)
76. (Previously Presented) The method of claim 75, 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- related to data gathering, specifying the type of sample to be analyzed.)
77. (Previously Presented) The method of claim 75, wherein the biological sample associated with metal metabolism of the subject is the tooth, and wherein the reference line corresponds to a neonatal line of the tooth on an enamel surface of the tooth.
(EIA- related to data gathering, specifying the type of sample to be analyzed.)
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 portion 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. (Previously Presented) A device for evaluating a subject for a biological condition associated with metal metabolism 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: [the method of claim 68]
(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.
89. See analysis of claim 72.
90. See analysis of claim 73.
91. See analysis of claim 74.
92. See analysis of claims 75-76.
93. see analysis of claim 77.
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, 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 embraced by claim(s) 68-97:
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. 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 identified abstract ideas are not integrated into a practical application. The claims were examined further to determine whether they integrated any JE into a practical application (MPEP 2106.04(d)). The claimed additional elements are analyzed alone, or in combination to determine if the JE is integrated into a practical application (MPEP 2106.05(a-c, e, f and h)).
Claim(s) 68, 69, 72, 75-82, 84, 86, 89, 92-97 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 needed to carry out the JE. The data gathering does not impose any meaningful limitation on the JE, or how the JE is performed. The additional limitation (data gathering) must have more than a nominal or insignificant relationship to the identified judicial exception. (MPEP 2106.04/.05, citing Intellectual Ventures LLC v. Symantec Corp, McRO, TLI communications, OIP Techs. Inc. v. Amason.com Inc., Electric Power Group LLC v. Alstrom S.A.).
Claim(s) 86, 97 recite the additional non-abstract element (EIA) of a general-purpose computer system or parts thereof.
The EIA do not provide any details of how specific structures of the computer elements are used to implement the JE. The claims require nothing more than a general-purpose computer to perform the functions that constitute the judicial exceptions. The computer elements of the claims do not provide improvements to the functioning of the computer itself (as in DDR Holdings, LLC v. Hotels.com LP); they do not provide improvements to any other technology or technical field (as in Diamond v. Diehr); nor do they utilize a particular machine (as in Eibel Process Co. v. Minn. & Ont. Paper Co.). 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 rejected claims do not recite a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). The additional elements were considered individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to claim(s) 68, 69, 72, 75-82, 84, 86, 89, 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.
Becker et al. (2010; PTO-1449) obtain samples from plants, sample positions along the leaf sample in the direction of growth over time and obtain traces by carrying out mass spectrometry, obtaining features related to Cu, K, B, Mn and P ions.
Curtin et al (2017; PTO-1449) obtain tooth samples from patients, sample positions along the tooth in the direction of growth, and obtain traces by carrying out mass spectrometry, obtaining features related to Zn, Mn, Mg, Ca, Cr, As and Pb ions.
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 (as in Alice Corp., CyberSource v. Retail Decisions, Parker v. Flook).
Activities such as data gathering do not improve the functioning of a computer, or comprise an improvement to any other technical field. The limitations do not require or set forth a particular machine, they do not effect a transformation of matter, nor do they provide an unconventional step (citing McRO and Trading Technologies Int’l v. IBG). Data gathering steps constitute a general link to a technological environment. 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 Pozebon, Becker and Curtin 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.
These elements do not improve the functioning of the computer itself, or comprise an improvement to any other technical field (Trading Technologies Int’l v IBG, TLI Communications). They do not require or set forth a particular machine (Ultramercial v. Hulu, LLC., Alice Corp. Pty. Ltd v. CLS Bank Int’l), they do not effect a transformation of matter, nor do they provide an unconventional step. 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., CyberSource v. Retail Decisions, Parker v. Flook, Versata Development Group v. SAP America).
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.
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 68-97 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The metes and bounds of claim 1 are unclear, with respect to the nature of the “biological condition(s) associated with metal metabolism.” The subject to be diagnosed is not limited to any particular type of subject (pro/ eukaryotic, mammal, human, reptile, et al). The possible diseases which are “associated” with metal metabolism are unclear for the scope of the claim. Some diseases related to metal metabolism have a genetic basis (Wilson Disease, hemochromatosis, Menkes syndrome, Acrodermatitis Enteropathica, NBIA), while others have an environmental basis (Alzheimer’s, Parkinson’s, ALS, Cancer, Liver disease, cardiovascular disease), or are related to deficiencies in critical elements (iron deficiency anemia, selenium deficiency, chromium deficiency, iodine deficiency). It is unclear whether all disorders or all associated biological conditions are intended to be diagnosed by the steps of the claim, nor is it clear how to diagnose or evaluate the conditions for which there is no specific metal-related information in the specification in the listed tables.
The metes and bounds of claim 1 are further unclear with respect to the nature of the “samples associated with metal metabolism.” The subjects from which the samples are obtained are not limited, nor is the type of sample to be retrieved. Metals are not metabolized in the way of organic compounds in that they are not broken down into components, but they are processed, stored and excreted in several places and processes, depending on the organism, and the particular metal. Metal processing occurs in multiple places and organ systems in the mammals, including in the intestines, kidney, liver, bones, and brain. Metal depositions can be detected in hair, whiskers, fingernails, toenails, claws, hooves and teeth. Metals can also be detected in bodily fluids such as plasma and urine. It is unclear what particular samples for the subject are intended to be tested in the pending claims. The description of the reference line, sampling along the direction of growth et al could be applied to bones other than teeth. Time series could be collected for numerous types of samples. While the specification indicates that hair and teeth are preferred samples, there is not a limited definition of the scope of samples to be encompassed.
The metes and bounds of the features to be identified are unclear. The claim fails to particularly point out and distinctly claim the 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 1 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 1, 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 claim 69 and 71, and the inclusion of information from certain tables: “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)” MPEP 2173.05(s).
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 claims 83, the claim fails to particularly point out and distinctly claim how the identification of the features is to be carried out with the information at hand from carrying out the method of claim 68. The nature of the “determinism” is entirely unclear with respect to the data provided in claim 68. The claim fails to particularly point out and distinctly claim how “a recurrence time” is to be calculated or determined from the data provided by claim 68. The claim fails to particularly point out and distinctly claim how the “entropy trapping time” is to be calculated or determined from the data provided by claim 68. The claim similarly fails to particularly point out and distinctly claim how the “laminarity” is to be determined from the data provided by claim 68. It is unclear if these elements are intended to be applied to the classifier of claim 68, and the claim fails to point out and distinctly claim how these data affect the classification process by the trained classifier. 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.
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) 68-71, 75, 77, 80-84, 86, 88, 92-93, 96 and 97 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Curtin.
Curtin, P. et al. (2017) Recurrence quantification analysis to characterize cyclical components of environmental elemental exposures during fetal and post-natal development. PLOS One, 12(11): e0187049. 16 pages. PTO-1449.
With respect to claims 68, 86 and 97, Curtin obtains teeth from subjects. (materials and methods, p3) The teeth are sampled along the line of growth to obtain a plurality of ion samples. (p3). Each ion sample is analyzed using LA-ICP-MS to obtain a plurality of traces. (p3-4). The traces indicate a concentration of each isotope, relative to a reference level, over time. See Figures 1 and 2. A second dataset is derived that include a set of features, including recurrence time, mean diagonal length, determinism, entropy, trapping time, and laminarity. (p6). The data is applied to a trained classifier to indicate a disorder associated with metal metabolism (neurotoxicity). (p7, linear mixed models, Tukey analysis, SW tests, etc.). The ions tested included Ca, Mn, Cu, As, Zn, Pb. The analyses are performed on computing devices, and use various programs and instructions meeting claims 86 and 97.
With respect to claim 69, at least one of the elements of Curtin is listed in Table 1.
With respect to claim 70, and claim 88 at least one trace is provided per element (See Figures).
With respect to claim 71, the features of Curtin meet at least one of the “features” of the listed tables, as set forth in the Tables 1 and 2.
With respect to claims 75, 77, and 92 Curtin analyzes teeth.
With respect to claim 80, Curtin uses LA-ICP-MS.
With respect to claim 81, and claim 93, the tooth is sampled along the tooth from one tip to the root.
With respect to claim 82, and claim 96 control isotopes are determined.
With respect to claim 83, mean diagonal length, determinism, recurrence time, entropy, trapping time and laminarity are each calculated, as set forth in Tables 1 and 2.
With respect to claim 84, Curtin shows periodic dysregulation of metals (figures.)
Claim(s) 68-72, 75, 77, 80-84, 85-89, 92-93, 96 and 97 is/are rejected under 35 U.S.C. 102a2 as being anticipated by Curtin 2 (2018).
The 6/6/2019 date is the effective filing date for claims 68-70, 75-83, 85-89, 92-97 for the evaluation for autism spectrum disorder. The effective filing dates for claims 71-74, 84, 90-91 is 6/5/2020.
Curtin, P. et al. (30 May 2018) (Curtin 2, or C2) Dynamical features in fetal and postnatal zinc-copper metabolic cycles predict the emergence of autism spectrum disorder. Science Advances, vol 4: eaat1293, 8 pages. PTO-1449.
The applied reference has a common inventor (Austin, Curtin, Arora) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
C2 seeks to define profiles for specific metal ions for the classification or evaluation of subjects for ASD. (Abstract.) C2 obtains teeth for the subjects. (Materials and methods, p5-6 and supplemental material.) The teeth were sampled along the direction of growth to obtain a plurality of ion samples. (p5). Each ion sample was analyzed by LA-ICP-MS, to obtain a plurality of traces for control isotopes and test isotopes (supplemental material). A dataset of features was derived, which included recurrence time, mean diagonal length, determinism, entropy, trapping time, and laminarity. (Results, p2-3, Fig 1, Fig 2). The features were applied to a trained classifier to determine a likelihood or probability that the subject has a metal metabolism condition, ASD. (Fig 3, Statistical analysis, p3-5, Materials and methods, p 6-7, Supplemental information.). The analyses were carried out using computing devices comprising programs and instructions. As such, claims 68, 86 and 97 are anticipated.
With respect to claim 69, at least one of the elements of C2 is listed in the supplemental information.
With respect to claim 70, and claim 88 at least one trace is provided per element (See Figures).
With respect to claim 71, the features of C2 meet at least one of the “features” of the listed tables, as set forth in Fig 2 and the supplemental information.
With respect to claims 72, and 89 C2 is concerned with ASD.
With respect to claims 75, 77, and 92 C2 analyzes teeth.
With respect to claim 80, C2 uses LA-ICP-MS.
With respect to claim 81, and claim 93, the tooth is sampled along the tooth from one tip to the root. (supplemental material)
With respect to claim 82, and claim 96 control isotopes are determined. (supplemental material)
With respect to claim 83, mean diagonal length, determinism, recurrence time, entropy, trapping time and laminarity are each calculated, as set forth in Fig 2 and the supplemental material.
With respect to claim 84, C2 shows periodic dysregulation of metals (figures.)
With respect to claims 85 and 87, C2 provides an indication of ASD in Fig 3.
Claim(s) 68-70, 72, 75-76, 78, 80-81, 82, 86, 88-89, 92, 94, 96-97 is/are 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). BB obtains hair samples from the subjects (p250). The hair samples were treated with detergent prior to analysis. Samples along the hair were obtain to obtain ion samples. The ion samples were analyzed by ICP-MS to obtain a plurality of traces (P250). A dataset derived from the traces is obtained, and applied to a trained classifier, to generate a determination (p250-251). Tables 4 and 5 indicate the metal ion or trace metal tested, the value in the test and control population, and the p value. Discriminatory values between ASD and controls for heavy metal exposure were found for arsenic, cadmium, barium, cesium and lead. Discriminatory values between ASD and controls for the trace metals of magnesium, lithium, zinc, and iron are provided. BB uses computers, comprising computer programs such as SPSS, meeting claims 86 and 97.
With respect to claim 69, at least one of the elements identified by BB is present in Table 1.
With respect to claim 70, and claim 88, LCP-MS provides a trace for each detected ion.
With respect to claim 72, and claim 89, ASD is analyzed.
With respect to claims 75-76, 92, BB analyzes hair, along the growth of the hair.
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.
Claim(s) 71-74, 84, 90-91 is/are rejected under 35 U.S.C. 102a2 as being anticipated by Austin (2019).
As set forth above, the provisional application does not provide basis for identifying any other disorder than ASD, or discriminating any other disorder from the first disorder of ASD, as only the table reciting the features of ASD is present in the provisional (Table 4). No features for any other disorder are specifically provided. The effective filing dates for claims 71-74, 84, 90-91 is 6/5/2020.
Austin, C. et al. (September, 2019) Dynamical properties of elemental metabolism distinguish attention deficit hyperactivity disorder from autism spectrum disorder. Translational Psychiatry, vol 9: 238. 9 pages. PTO-1449
The applied reference has a common inventor (Austin, Curtin, Arora) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Austin obtains teeth from subjects, and determines temporal profiles of ions in the teeth by MS for the ions of cobalt, lead, vanadium. Austin obtains the teeth, and samples the surface of the teeth by LA-ICP-MS along the line of growth. A multiplicity of traces is obtained. Austin generates a set of features, the second dataset, which comprise regularity (determinism), and complexity (entropy) for each ion. The features extracted are applied to a trained classifier, and can be used to discriminate between ASD and ADHD. (Materials and methods, p2-4, Results p4-8.)
Claim(s) 68-70, 75, 76, 80, 81-82, 84, 85-88, 92, 96 and 97 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Ash (2018).
Ash, R. D. et al. (9 October, 2018) Details of a thallium poisoning case revealed by single hair analysis using laser ablation inductively coupled plasma mass spectrometry. Forensic Science International, Vol 202, p224-231. (PTO-892).
With respect to claims 68, 86 and 97, Ash obtains hair samples from subjects. (Abstract, Materials and methods p 225, section 3.1-3.2.) The hair samples were sampled along the line of growth to obtain a plurality of ion samples. (Section 3.3). Each ion sample is analyzed using LA-ICP-MS to obtain a plurality of traces. (Section 3.3, p225-226). LA-ICP-MS parameters are provided at Table 1. Reference materials were also analyzed. The traces indicate a concentration of thallium and lead, relative to a reference level, over time. See Figures 1, 2, 4 and 5. A second dataset is derived that include a set of features, representing concentration values calculated by computing (Table 2). The data is applied to a statistical classifier to indicate a disorder associated with metal metabolism (Thallium poisoning). (p226, Section 3.5, Data processing). The analyses are performed on computing devices, and use various programs and instructions meeting claims 86 and 97.
With respect to claim 69, lead (Pb) is listed in Table 1.
With respect to claim 70, and claim 88 at least one trace is provided per element (See Figures).
With respect to claims 75, 77, 92, Ash analyzes hair samples.
With respect to claim 80, Ash uses LA-ICP-MS.
With respect to claim 81, and claim 93, the hair is sampled along the hair from one tip to the root.
With respect to claim 82, and claim 96 control isotopes are determined.
With respect to claim 84, Ash shows periodic dysregulation of metals (figures.)
With respect to claims 85 and 87, the presence of poisoning is extremely probable.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 75, 76, 78, 92, 94 is/are rejected under 35 U.S.C. 103 as being unpatentable over Curtin (2017) as applied to claim(s) 68-71, 75, 77, 80-84, 86, 88, 92-93, 96 and 97 above, in view of Dressler (2010).
Curtin, P. et al. (2017) Recurrence quantification analysis to characterize cyclical components of environmental elemental exposures during fetal and post-natal development. PLOS One, 12(11): e0187049. 16 pages. PTO-1449.
Dressler, V. P. et al. Biomonitoring of essential and toxic metals in single hair using on-line solution-based calibration in laser ablation inductively coupled plasma mass spectrometry. Talanta, vol 82, p1710-1777. PTO-1449.
As set forth above, Curtin provides the overall method for the analysis of certain samples with LA-ICP-MS, to detect metal ions/isotopes which can correlate to a disease. Curtin does not analyze hair samples.
With respect to the overall method, system and program of claims 68, 86 and 97, Curtin obtains teeth from subjects. (materials and methods, p3) The teeth are sampled along the line of growth to obtain a plurality of ion samples. (p3). Each ion sample is analyzed using LA-ICP-MS to obtain a plurality of traces. (p3-4). The traces indicate a concentration of each isotope, relative to a reference level, over time. See Figures 1 and 2. A second dataset is derived that includes a set of features, including recurrence time, mean diagonal length, determinism, entropy, trapping time, and laminarity. (p6). The data is applied to a trained classifier to indicate a disorder associated with metal metabolism (neurotoxicity). (p7, linear mixed models, Tukey analysis, SW tests, etc.). The ions tested included Ca, Mn, Cu, As, Zn, Pb. The analyses are performed on computing devices, and use various programs and instructions meeting claims 86 and 97.
In the same field of research, analyzing toxic and essential metal ions in samples using MS, Dressler provides details on the use of hair samples from subjects. Dressler obtains hair samples from humans, and mice. The hair samples are washed with detergent prior to sampling and analysis (Figures 1 and 2). The hair is sampled along its length to obtain multiple ion samples, which are analyzed by LA-ICP-MS to obtain a plurality of traces (Table 1 lists LA-ICP-MS parameters; Fig 3 illustrates a plurality of traces). The traces indicate a concentration of each isotope, relative to a reference level, over time (Fig 4). The traces for Fig 4 illustrate concentrations of Li, Mg, K, Mn, Cu, Zn, S, B, PB and Bi. A second dataset is derived that includes a set of features for each analyte, in Tables 2 and 3. The analyses are performed on computing devices, and use various programs and instructions.
In KSR Int 'l v. Teleflex, the Supreme Court, in rejecting the rigid application of the teaching, suggestion, and motivation test by the Federal Circuit, indicated that “The principles underlying [earlier] cases are instructive when the question is whether a patent claiming the combination of elements of prior art is obvious. When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR Int'l v. Teleflex lnc., 127 S. Ct. 1727, 1740 (2007).
Applying the KSR standard of obviousness to the methods of Curtin and Dressler, substitution of hair samples as taught by Dressler for the analysis of teeth for the evaluation of a subject for a biological condition related to metal metabolism as taught by Curtin is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement." Dressler teaches how the sampling of hair is to be performed for humans, and mice, including the treatment of the hair with a solvent or a detergent prior to sampling using the same LA-ICP-MS processes as Curtin. Dressler teaches that the hair does contain metal ions, and demonstrates comparison of sample values with known, control values. Dressler notes that hair samples are easy to obtain, which represents an improvement over Curtin’s use of naturally lost, or removed teeth from subjects. Thus, it would have been obvious to one of ordinary skill in the art to replace the tooth samples of Curtin with the hair samples of Dressler, because one of ordinary skill in the art would have been able to carry out such a substitution, and the results were reasonably predictable. Such a combination is merely a "predictable use of prior art elements according to their established functions." KSR Int’l 7, 127 S. Ct. at 1740.
Claim(s) 79 and 95 is/are rejected under 35 U.S.C. 103 as being unpatentable over Curtin as applied to claim(s) 68-71, 75, 77, 80-84, 86, 88, 92-93, 96 and 97 in view of Schloglova et al (2017).
Curtin, P. et al. (2017) Recurrence quantification analysis to characterize cyclical components of environmental elemental exposures during fetal and post-natal development. PLOS One, 12(11): e0187049. 16 pages. PTO-1449.
Schloglova et al. LA-ICP-MS analysis of fluid inclusions: contamination effects challenging micro-analysis of elements close to their detection limit. J. Anal. At. Spectrom. Vol 32, p1052-1054.
As set forth above, Curtin provides the overall methods as claimed. Curtin does not pre-ablate the surface of the sample using a low powered laser to remove debris. Curtin obtains teeth from subjects. (materials and methods, p3) The teeth are sampled along the line of growth to obtain a plurality of ion samples. (p3). Each ion sample is analyzed using LA-ICP-MS to obtain a plurality of traces. (p3-4). The traces indicate a concentration of each isotope, relative to a reference level, over time. See Figures 1 and 2. A second dataset is derived that include a set of features, including recurrence time, mean diagonal length, determinism, entropy, trapping time, and laminarity. (p6). The data is applied to a trained classifier to indicate a disorder associated with metal metabolism (neurotoxicity). (p7, linear mixed models, Tukey analysis, SW tests, etc.). The ions tested included Ca, Mn, Cu, As, Zn, Pb. The analyses are performed on computing devices, and use various programs and instructions.
Curtin does not use pre-ablation of the tooth prior to the application of the LA-ICP-MS.
In the same field of analysis, using LA-ICP-MS to analyze elements in a sample, Schloglova analyzes various sources of contamination in LA-ICP-MS analysis of solids. Schloglova finds several possible sources of contamination, and ways to overcome, prevent, or control for that contamination. With respect to the contamination present in the sample, Schloglova notes that the cleanliness of the surface of the sample is important, and can require more than simple washing with water, or solvent, or surfactant. This discussion begins at p 1059, and is illustrated at Fig 5. Schloglova washes the surface with water, and ultrasonic rinsing, followed by a pre-ablation and a faster ablation time for the actual analysis. The process of Schloglova provides traces of elements with fewer instances of noise and contaminants, leading to a cleaner trace and better data analysis.
In KSR Int 'l v. Teleflex, the Supreme Court, in rejecting the rigid application of the teaching, suggestion, and motivation test by the Federal Circuit, indicated that “The principles underlying [earlier] cases are instructive when the question is whether a patent claiming the combination of elements of prior art is obvious. When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR Int'l v. Teleflex lnc., 127 S. Ct. 1727, 1740 (2007).
Applying the KSR standard of obviousness to Curtin and Schloglova the Examiner concludes that the combination of the water washing of the sample and the pre-ablation step as disclosed by Schloglova to the samples of teeth as disclosed by Curtin represents the use of a known technique to improve similar methods. The nature of the problem to be solved may lead inventors to look at references relating to possible solutions to that problem. LA-ICP-MS was known to be sensitive to the presence of contaminants on the surfaces of samples, as discussed by Schloglova. Schloglova indicated that a simple washing with water was insufficient to remove all surface contaminants, and provided a technical solution to the problem: pre-ablation using the laser of the LA-ICP-MS system, the same system used by Curtin. Therefore, it would have been obvious to use pre-ablation of the sample surface with a laser, on the samples of Curtin to remove surface contamination of the teeth. Using the known technique of pre-ablation to provide removal or destruction of the surface contaminants would have been obvious to one of ordinary skill in the art at the time of filing, absent evidence to the contrary.
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 68-97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 131-167 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/MARY K ZEMAN/ Primary Examiner, Art Unit 1686