DETAILED ACTION
Comments
The present application is being examined under the pre-AIA first to invent provisions. 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 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.
Claims 1-3, 9-10, 14, 16, 45, 57, and 60-61 are pending and examined in the instant Office action.
Information Disclosure Statement
The IDSs submitted have been considered.
Claim Interpretation
Paragraph 36 of the specification defines GlycA to be the compounds represented in the 1.845 ppm to 2.080 ppm region in the NMR spectral data.
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.
Claim(s) 1-3, 9-10, 14, 16, 45, 57, and 60-61 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea/law of nature/natural phenomenon without significantly more. Claims 1-3, 9-10, 14, 16, and 60-61 are drawn to methods, and claims 45 and 57 are drawn to systems comprising NMR spectrometers.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1 : YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claim 1 recites the mental steps of calculating a diabetes risk index score using NMR data from a lipoprotein, a branched chain amino acid, and an inflammatory biomarker.
Claim 2 recites the mental steps of having different mathematical models for statin versus non-stain therapies.
Claim 3 recites the mental steps of having different mathematical models for fasting versus non-fasting samples.
Claim 9 recites the mental step of constraining the mathematical risk model to include only NMR measurements.
Claim 10 recites the mental steps of deconvolving the NMR spectra and calculating NMR derived measurements of GlycA and selected lipoprotein parameters based on the deconvolved NMR spectrum.
Claim 14 recites the mental step of constraining the types of lipoproteins included in the analysis.
Claim 16 recite the mental step and mathematical limitation of the model including a ratio of medium HDL-P to total HDL-P.
Claim 45 recites the mental step of applying a model to NMR data to obtain a diabetes risk score.
Claim 57 recites the mental steps of calculating concentration measurements of GlycA, valine, and lipoprotein biomarkers, and calculating a diabetes risk score based on this data.
Claim 60 recites the mental step of including in the model for patients with statis therapy components that are statin insensitive.
Claim 61 recite the mental step of including in the mathematical model for fasting samples different lipoprotein components than the mathematical model for non-fasting samples.
These recitations are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then if falls within the “Mental processes” grouping of abstract ideas. As such, claim(s) 1-3, 9-10, 14, 16, 45, 57, and 60-61 recite(s) an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 1 : YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology or applies or uses the recited judicial exception to affect a particular treatment for a condition. Rather, the instant claims recite additional elements that amount to mere instructions to implement the abstract idea in a generic computing environment or mere instructions to apply the recited judicial exception via a generic treatment.
As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. As such, claims 1-3, 9-10, 14, 16, 45, 57, and 60-61 is/are directed to an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 2 : NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment.
The review article of Moolenaar et al. [Ann Clin Biochem, volume 40, 2003, pages 16-24; on IDS] teaches that performing NMR measurements on in vitro biological samples is routine and conventional in the prior art.
Figure 5 of Otvos [US PGPUB 2010/010034 A1; on IDS] teaches that it is routine and conventional to measure lipoprotein data in the GlycA region of the NMR spectra (i.e. 1.845 ppm to 2.080 ppm).
As discussed above, there are no additional limitations to indicate that the claimed analysis engine requires anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. The limitation for treating the tumor cells equate to mere instructions to apply the judicial exception in a generic way because the treating step is so generically recited. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B : No). As such, claims 1-3, 9-10, 14, 16, 45, 57, and 60-61 is/are not patent eligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 45 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Barzilai [US Patent 7,491,543 B2; on IDS].
Claim 45 is drawn to a system comprising an NMR spectrometer for acquiring an NMR spectrum of an in vitro biosample. The system comprises a processor in communication with the NMR spectrometer. The processor is configured to use the NMR spectrum to determine a diabetes risk index score based on a defined mathematical model of risk.
The document of Barzilai is drawn to using biomarkers such as lipoproteins to assess likelihood and longevity of diseases [title]. Column 1, lines 28-40 and column 4, lines 7-23 of Barzilai teach that one of the applicable diseases is type 2 diabetes. The statistical analyses (i.e. mathematical modeling) that result in disease likelihoods (i.e. risk scores) in the figures involve lipoproteins (e.g. HDL and LDL). Column 7, lines 22-33 of Barzilai also suggests that the mathematical modeling related to the branched chain amino acid valine. Column 25, line 65 to column 26, line 10 of Barzilai teaches that the blood sample analyzed is analyzed in vitro. The blood test is conducted immediately (i.e. within 5 years of when the sample is taken from the patient). Column 26, lines 34-45 of Barzilai teaches that NMR is used to analyze samples.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
35 U.S.C. 103 Rejection #1:
Claims 1, 9, 14, 16, and 45 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barzilai [US Patent 7,491,543 B2; on IDS] in view of McKenna et al. [WO 2011/059720 A2; on IDS].
Claim 1 is drawn to a method of evaluating a subject’s risk of developing type 2 diabetes. The method comprises programmatically calculating a diabetes risk index score of a subject using at least one defined mathematical model that includes at least one lipoprotein content, at least one branched chain amino acid, and at least one inflammatory biomarker obtained from at least one in vitro biosample of the subject.
The document of Barzilai is drawn to using biomarkers such as lipoproteins to assess likelihood and longevity of diseases [title]. Column 1, lines 28-40 and column 4, lines 7-23 of Barzilai teach that one of the applicable diseases is type 2 diabetes. The statistical analyses (i.e. mathematical modeling) that result in disease likelihoods (i.e. risk scores) in the figures involve lipoproteins (e.g. HDL and LDL). Column 7, lines 22-33 of Barzilai also suggests that the mathematical modeling related to the branched chain amino acid valine. Column 25, line 65 to column 26, line 10 of Barzilai teaches that the blood sample analyzed is analyzed in vitro. The blood test is conducted immediately (i.e. within 5 years of when the sample is taken from the patient). Column 26, lines 34-45 of Barzilai teaches that NMR is used to analyze samples.
Barzilai does not teach that the mathematical model includes an inflammatory biomarker.
The document of McKenna et al. studies a method for determining risk of diabetes [title]. The abstract of McKenna et al. teaches measuring the inflammatory biomarker of CRP. The equation on pages 1-2 of McKenna et al. teaches a mathematical model for calculating diabetes risk.
With regard to claim 9, the abstract of Barzilai teaches analysis of plasma.
With regard to claims 14 and 16, Tables 1 and 9 in columns 43-49 of Barzilai teach size and particle number for VLDL and HDL. Figures 2 and 3A illustrate the HDL particle data from which the ratio of medium HDL-P to total HDL-P is deductible.
It would have been obvious to someone of ordinary skill in the art at the time of the instant invention to modify the correlation of lipoprotein levels and valine with type 2 diabetes as in Barzilai by use of the correlation between the inflammatory biomarker of CRP with type 2 diabetes of McKenna et al. because it is obvious to combine known elements in the prior art to yield a predictable result. In this instance, the correlation between CRP and diabetes is an alternative to the correlations between lipoprotein and/or valine and diabetes. There would have been a reasonable expectation of success in combining Barzilai and McKenna et al. because both studies analogously pertain to mathematically modelling risk factors of diabetes to the development of diabetes.
35 U.S.C. 103 Rejection #2:
Claims 2-3 and 60-61 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barzilai in view of McKenna et al., as applied to claims 1, 9, 14, 16, and 45 above, in further view of Otvos [US PGPUB 2010/0100334 A1; on IDS].
Claim 2 recite using different mathematical models for statin versus non-statin therapies.
Claim 3 recites using different mathematical models for fasting versus non-fasting sample.
Claim 60 requires the mathematical model for subjects on a statin therapy to include lipoprotein components that are statin insensitive.
Claim 61 requiring the mathematical model for fasting biosamples to comprise different lipoprotein components than the mathematical model for non-fasting biosamples.
Barzilai and McKenna et al. make obvious modeling diabetes risk scores using analysis of lipoprotein data obtained by NMR, as discussed above.
Barzilai and McKenna et al. do not teach the limitations of the aforementioned dependent claims.
The document of Otvos studies lipoprotein insulin resistance indexes and related methods [title]. Paragraph 68 of Otvos teaches using different mathematical modeling techniques for statin therapies versus non-statin therapies and fasting samples versus non-fasting samples. Paragraph 68 of Otvos teaches concentration measurements in water are relevant for the modeling of the risk score wherein water is a lipoprotein component (i.e. hydrogen bonded to the protein) that is not statin sensitive. Paragraphs 12-13 of Otvos teach that different sets of lipoproteins are available for modeling in fasting versus non-fasting samples.
It would have been obvious to someone of ordinary skill in the art at the time of the instant invention to modify the correlation of lipoprotein levels and valine with type 2 diabetes as in Barzilai and the correlation between the inflammatory biomarker of CRP with type 2 diabetes of McKenna et al. by use of the modeling techniques of Otvos wherein the motivation would have been that the additional mathematical techniques add modeling tools for understanding the relation between lipoprotein NMR measurements and diabetes risk [paragraphs 12-13 and 68 of Otvos].
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.
Double Patenting Rejection #1:
Claim 45 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,361,429 B2 [on IDS]. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are analogously drawn to determining diabetes risk scores based on applying mathematical models to NMR data. While the claim of ‘429 recites additional subject matter relative to the instantly rejected claim, the claim of ‘429 anticipates the instantly rejected claim.
Double Patenting Rejection #2:
Claims 1-3, 9-10, 14, 16, 57, and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 10-11, 7, 16, 47, and 18, respectively, of U.S. Patent No. 9,361,429 B2 [on IDS] in view of McKenna et al. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are analogously drawn to determining diabetes risk scores based on applying mathematical models to NMR data. While the claims of ‘429 pertain to measuring branched amino acids, lipoproteins, and GlycA, the claims of ‘429 do not teach measuring inflammatory biomarkers.
The document of McKenna et al. studies a method for determining risk of diabetes [title]. The abstract of McKenna et al. teaches measuring the inflammatory biomarker of CRP. The equation on pages 1-2 of McKenna et al. teaches a mathematical model for calculating diabetes risk.
It would have been obvious to someone of ordinary skill in the art at the time of the instant invention to modify the correlation of lipoprotein levels and valine with type 2 diabetes as in the claims of ‘429 by use of the correlation between the inflammatory biomarker of CRP with type 2 diabetes of McKenna et al. because it is obvious to combine known elements in the prior art to yield a predictable result. In this instance, the correlation between CRP and diabetes is an alternative to the correlations between lipoprotein and/or valine and diabetes. There would have been a reasonable expectation of success in combining the claims of ‘429 and McKenna et al. because both studies analogously pertain to mathematically modelling risk factors of diabetes to the development of diabetes.
Double Patenting Rejection #3:
Claim 61 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,361,429 B2 [on IDS] in view of McKenna as applied to Double Patenting Rejection #2 above, in further view of Otvos. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are analogously drawn to determining diabetes risk scores based on applying mathematical models to NMR data. While the claim of ‘429 pertains to measuring branched amino acids, lipoproteins, and GlycA, the claim of ‘429 does not teach measuring inflammatory biomarkers. The claim of ‘429 does not teach different lipoprotein combinations for fasting versus non-fasting samples.
The document of Otvos studies lipoprotein insulin resistance indexes and related methods [title]. Paragraphs 12-13 of Otvos teach that different sets of lipoproteins are available for modeling in fasting versus non-fasting samples.
It would have been obvious to someone of ordinary skill in the art at the time of the instant invention to modify the correlation of lipoprotein levels and valine with type 2 diabetes as in the claim of ‘429 and the correlation between the inflammatory biomarker of CRP with type 2 diabetes of McKenna et al. by use of the modeling techniques of Otvos wherein the motivation would have been that the additional mathematical techniques add modeling tools for understanding the relation between lipoprotein NMR measurements and diabetes risk [paragraphs 12-13 and 68 of Otvos].
Double Patenting Rejection #4:
Claim 45 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,388,414 B2 [on IDS]. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are analogously drawn to determining diabetes risk scores based on applying mathematical models to NMR data. While the claim of ‘414 recites additional subject matter relative to the instantly rejected claim, the claim of ‘414 anticipates the instantly rejected claim.
Double Patenting Rejection #5:
Claims [1 or 57], 2-3, 9-10, 14, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 5-6, 7, 12, and 14, respectively, of U.S. Patent No. 10,388,414 B2 [on IDS] in view of McKenna et al. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are analogously drawn to determining diabetes risk scores based on applying mathematical models to NMR data. While the claims of ‘414 pertain to measuring branched amino acids, lipoproteins, and GlycA, the claims of ‘414 do not teach measuring inflammatory biomarkers.
The document of McKenna et al. studies a method for determining risk of diabetes [title]. The abstract of McKenna et al. teaches measuring the inflammatory biomarker of CRP. The equation on pages 1-2 of McKenna et al. teaches a mathematical model for calculating diabetes risk.
It would have been obvious to someone of ordinary skill in the art at the time of the instant invention to modify the correlation of lipoprotein levels and valine with type 2 diabetes as in the claims of ‘414 by use of the correlation between the inflammatory biomarker of CRP with type 2 diabetes of McKenna et al. because it is obvious to combine known elements in the prior art to yield a predictable result. In this instance, the correlation between CRP and diabetes is an alternative to the correlations between lipoprotein and/or valine and diabetes. There would have been a reasonable expectation of success in combining the claims of ‘414 and McKenna et al. because both studies analogously pertain to mathematically modelling risk factors of diabetes to the development of diabetes.
Double Patenting Rejection #6:
Claim [60 or 61] is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,388,414 B2 [on IDS] in view of McKenna et al. as applied to Double Patenting Rejection #5 above, in further view of Otvos. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are analogously drawn to determining diabetes risk scores based on applying mathematical models to NMR data. While the claim of ‘414 pertains to measuring branched amino acids, lipoproteins, and GlycA, the claim of ‘414 does not teach measuring inflammatory biomarkers. The claim of ‘414 does not teach different lipoprotein combinations for fasting versus non-fasting samples.
The document of Otvos studies lipoprotein insulin resistance indexes and related methods [title]. Paragraphs 12-13 of Otvos teach that different sets of lipoproteins are available for modeling in fasting versus non-fasting samples. Paragraph 68 of Otvos teaches concentration measurements in water are relevant for the modeling of the risk score wherein water is a lipoprotein component (i.e. hydrogen bonded to the protein) that is not statin sensitive.
It would have been obvious to someone of ordinary skill in the art at the time of the instant invention to modify the correlation of lipoprotein levels and valine with type 2 diabetes as in the claim of ‘414 and the correlation between the inflammatory biomarker of CRP with type 2 diabetes of McKenna et al. by use of the modeling techniques of Otvos wherein the motivation would have been that the additional mathematical techniques add modeling tools for understanding the relation between lipoprotein NMR measurements and diabetes risk [paragraphs 12-13 and 68 of Otvos].
Double Patenting Rejection #7:
Claim 45 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim [1 or 5] of U.S. Patent No. 11,710,568 B2 [on IDS]. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are analogously drawn to determining diabetes risk scores based on applying mathematical models to NMR data. While the claim of ‘568 recites additional subject matter relative to the instantly rejected claim, the claim of ‘568 anticipates the instantly rejected claim.
Double Patenting Rejection #8:
Claims 1-3, 9-10, 14, 16, 57, and [60 or 61]are rejected on the ground of nonstatutory double patenting as being unpatentable over claim [1or 5], 2, 4, 8-9, 12-13, 25, and 18, respectively, of U.S. Patent No. 11,710,568 B2 [on IDS] in view of McKenna et al. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are analogously drawn to determining diabetes risk scores based on applying mathematical models to NMR data. While the claims of ‘568 pertain to measuring branched amino acids, lipoproteins, and GlycA, the claims of ‘568 do not teach measuring inflammatory biomarkers.
The document of McKenna et al. studies a method for determining risk of diabetes [title]. The abstract of McKenna et al. teaches measuring the inflammatory biomarker of CRP. The equation on pages 1-2 of McKenna et al. teaches a mathematical model for calculating diabetes risk.
It would have been obvious to someone of ordinary skill in the art at the time of the instant invention to modify the correlation of lipoprotein levels and valine with type 2 diabetes as in the claims of ‘568 by use of the correlation between the inflammatory biomarker of CRP with type 2 diabetes of McKenna et al. because it is obvious to combine known elements in the prior art to yield a predictable result. In this instance, the correlation between CRP and diabetes is an alternative to the correlations between lipoprotein and/or valine and diabetes. There would have been a reasonable expectation of success in combining the claims of ‘568 and McKenna et al. because both studies analogously pertain to mathematically modelling risk factors of diabetes to the development of diabetes.
Double Patenting Rejection #9:
Claims [1 or 45], 10, and 57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, and 22, respectively, of U.S. Patent No. 9,792,410 B2 [on IDS]. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are analogously drawn to determining diabetes risk scores based on applying mathematical models to NMR data. While the claims of ‘410 recites additional subject matter relative to the instantly rejected claim, the claims of ‘410 anticipates the instantly rejected claim.
Double Patenting Rejection #10:
Claim [9, 14, or 16] is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No 9,792,410 B2 [on IDS] in view of Barzilai in view of McKenna et al. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are analogously drawn to determining diabetes risk scores based on applying mathematical models to NMR data. While the claim of ‘410 pertains to measuring branched amino acids, lipoproteins, and GlycA, the claim of ‘410 does not teach limitations of the dependent claims.
With regard to claim 9, the abstract of Barzilai teaches analysis of plasma.
With regard to claims 14 and 16, Tables 1 and 9 in columns 43-49 of Barzilai teach size and particle number for VLDL and HDL. Figures 2 and 3A illustrate the HDL particle data from which the ratio of medium HDL-P to total HDL-P is deductible.
It would have been obvious to someone of ordinary skill in the art at the time of the instant invention to modify the correlation of lipoprotein levels and valine with type 2 diabetes as in the claim of ‘410 by use of the modeling of NMR data of Barzilai wherein the motivation would have been that Barzilai adds tools for the modeling of NMR data to generate a diabetes risk [abstract of Barzilai].
It would have been obvious to someone of ordinary skill in the art at the time of the instant invention to modify the correlation of lipoprotein levels and valine with type 2 diabetes as in the claim of ‘410 and Barzilai by use of the correlation between the inflammatory biomarker of CRP with type 2 diabetes of McKenna et al. because it is obvious to combine known elements in the prior art to yield a predictable result. In this instance, the correlation between CRP and diabetes is an alternative to the correlations between lipoprotein and/or valine and diabetes.
There would have been a reasonable expectation of success in combining the claim of ‘410, Barzilai, and McKenna et al. because both studies analogously pertain to mathematically modelling risk factors of diabetes to the development of diabetes.
Double Patenting Rejection #11:
Claim [2, 3, 60, or 61] is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,792,410 B2 [on IDS] in view of Barzilai in view of McKenna et al. as applied in Double Patenting Rejection #10 in further view of Otvos. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are analogously drawn to determining diabetes risk scores based on applying mathematical models to NMR data. While the claim of ‘410 pertains to measuring branched amino acids, lipoproteins, and GlycA, the claim of ‘410 does not teach measuring inflammatory biomarkers. The claim of ‘429 does not teach different lipoprotein combinations for fasting versus non-fasting samples.
The document of Otvos studies lipoprotein insulin resistance indexes and related methods [title]. Paragraph 68 of Otvos teaches using different mathematical modeling techniques for statin therapies versus non-statin therapies and fasting samples versus non-fasting samples. Paragraph 68 of Otvos teaches concentration measurements in water are relevant for the modeling of the risk score wherein water is a lipoprotein component (i.e. hydrogen bonded to the protein) that is not statin sensitive. Paragraphs 12-13 of Otvos teach that different sets of lipoproteins are available for modeling in fasting versus non-fasting samples.
It would have been obvious to someone of ordinary skill in the art at the time of the instant invention to modify the correlation of lipoprotein levels and valine with type 2 diabetes as in the claim of ‘410 and Barzilai and the correlation between the inflammatory biomarker of CRP with type 2 diabetes of McKenna et al. by use of the modeling techniques of Otvos wherein the motivation would have been that the additional mathematical techniques add modeling tools for understanding the relation between lipoprotein NMR measurements and diabetes risk [paragraphs 12-13 and 68 of Otvos].
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Related Prior Art
The document of Jeyarajah et al. [Clin. Lab. Med, volume 26, 2006, pages 847-807; on IDS] teaches lipoprotein analysis by NMR [title]. Figure 1 of Jeyarajah et al. illustrates the NMR spectrum of blood plasma. Figure 2 of Jeyarajah et al. illustrates particle size distributions of LDL and HDL after deconvolution of the first NMR spectra. Table 1 of Jeyarajah et al. lists the particle size distribution of VLDL, LDL, and HDL. Jeyarajah et al. does not teach GlycA.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Russell Negin, whose telephone number is (571) 272-1083. This Examiner can normally be reached from Monday through Thursday from 8 am to 3 pm and variable hours on Fridays.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Larry Riggs, Supervisory Patent Examiner, can be reached at (571) 270-3062.
/RUSSELL S NEGIN/Primary Examiner, Art Unit 1686 26 September 2026
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