DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 1-6, 9-19, and 232-233 are currently pending and under exam herein.
Priority
This application is a continuation of U.S. Application No. 14/832,427, filed August 21, 2015, now issued as U.S. Patent No. 11,300,575, which is a continuation of U.S. Application No. 12/905,984, filed October 15, 2010, now issued as U.S. Patent No. 9,200,324, on December 1, 2015, which claims the benefit of U.S. Provisional Application No. 61/252,110, filed on October 15, 2009, U.S. Provisional Application No. 61/304,3172 filed February 2, 2010, and U.S. Provisional Application 61/355,087, filed on June 15, 2010. Priority for each of the claims as above is acknowledged.
Information Disclosure Statement
No Information Disclosure Statement has been filed.
Applicant is kindly reminded of the duty to disclose matter material to patentability.
Drawings
The Drawings filed 3 March 2022 and the replacements filed 10 August 2022 are accepted.
Specification
Note: All references to the Specification herein pertain to the PG publication: US2022/0381795
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 1-6, 9-19, and 232-233 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1 Analysis: Are claims directed to process, machine, manufacture/composition of matter
With respect to step (1): yes, the claims are directed to a method for scoring a sample.
Step 2A, Prong 1 Analysis: Do claims recite abstract idea
With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and in conjunction with mathematical concepts (in particular mathematical relationships and formulas).
The claim steps to abstract ideas are as follows:
Claim 1: determining, a first DAI score from said first dataset using an interpretation function, wherein said first DAI score provides a quantitative measure of inflammatory disease activity in said first subject, wherein steps directed to “determining” are ones that can be mental in nature whereby when provided data one can assess a “determination” using math application of a score function.
Claim 3: wherein said inflammatory disease activity is rheumatoid arthritis disease activity and further comprising predicting a Sharp score change from said first subject, based on said DAI score, wherein the disease activity is further defined herein as RA disease activity thus further limiting the judicial exception and further wherein the step includes “predicting” a Sharp score. Steps of “predicting” are directed to mental activity wherein the Specification indicates that Sharp scores are calculations. See paragraph [0278].
Claim 4: DAI score is predictive of a clinical assessment, wherein said step further defines the score and limits the judicial exception herein.
Claim 5: interpretation function is based on a predictive model, wherein said function is a further limitation of the recited judicial exception.
Claim 6: wherein said clinical assessment is selected from the group consisting of. a DAS, a DAS28, a DAS28-CRP, a Sharp score, a tender joint count (TJC), and a swollen joint count (SJC), wherein said limitation is a further limitation to the judicial exception that describes the type of assessment.
Claim 9: wherein DAS28-CRP comprises a component selected from the group consisting of tender joint count (TJC), the swollen joint count (SJC), and the patient global health assessment, wherein said limitation is a further limitation to the judicial exception that describes the type of assessment.
Claim 13: wherein said predictive model is developed using an algorithm comprising a forward linear stepwise regression algorithm; a Lasso shrinkage and selection method for liner regression; or an Elastic Net for regularization and variable selection for linear regression, which further limits the judicial exception above using mathematical techniques as claimed.
Claim 14: determining a second DAI score from said second dataset using said interpretation function; and comparing said first DAI score and said second DAI score to determine a change in said DAI scores, wherein said change indicates a change in said inflammatory disease activity in said first subject, wherein steps directed to “determining” are ones that can be mental in nature whereby when provided data one can assess a “determination” using math application of a score function.
Claim 16: determining a rate of said change in DAI scores, wherein said rate indicates the extent of said first subject's response to a therapeutic regimen, wherein said steps of “determining” may mentally be performed by assessing data and comparing rates of change therein with appropriate mathematical functions.
Claim 18: determining a prognosis, which is directed to a mental step of making a determination given appropriate data.
Claim 232 is directed to making a selection when given appropriate data and is thus a mental activity.
Claim 233 is directed to making a determining when given appropriate data and is thus a mental activity.
Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance either in the mind (calculations by hand or pen and paper) and performance by mathematical operation (calculation for assessment of time points as per the recited specific equations in said claims). There are no specifics as to the methodology involved in “determining”, “predicting”, “comparing” beyond the above interpretations and thus, under the BRI, one could simply, for example, perform said operation with pen and paper. These recitations are similar to the concepts of collecting information, analyzing it and providing certain results from the collection and analysis (Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations (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 with pen and paper, and can include mathematical concepts.
Further, see MPEP § 2106.04(a)(2), subsection III. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation (see, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674: noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016): holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind" (see Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016): holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
Step 2A, Prong 2 Analysis: Integration to a Practical Application
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following additional elements:
Claim 1: “receiving a first dataset associated with a first sample obtained from a first subject…” which are operations that are directed to “getting data”.
Claim 2: “dataset is obtained by a method comprising: obtaining said first sample from said first subject, wherein said first sample comprises a plurality of analytes; contacting said first sample with a reagent; generating a plurality of complexes between said reagent and said plurality of analytes; and detecting said plurality of complexes to obtain said first dataset associated with said first sample, wherein said first dataset comprises quantitative data for said least two markers, which are operations directed to routine laboratory steps to collect data.
Claims 10-12 further limit the data received.
Claim 15 and 17 are further directed to disease type associated with said data.
Further with respect to the additional elements in the instant claims, those steps directed to data gathering perform functions of collecting the data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or on how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
Further, the courts have recognized the following laboratory techniques as insignificant extra-solution activity. See further, the MPEP at 2106.05(d)II.): determining the level of a biomarker in blood by any means (Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017)); detecting DNA or enzymes in a sample (Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017)).
Step 2B Analysis: Do Claims Provide an Inventive Concept
The claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the prior art as disclosed in the instant Specification at least at [0115] (as directed for example to CRP assays) discloses that each of said laboratory steps are directed to are data gathering elements as in 2A, prong 2 and that under the assessment herein under 2B encompass steps that are routine, well-understood and conventional in the art.
The courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (see MPEP 2106.05(d)II.): determining the level of a biomarker in blood by any means (Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017)); detecting DNA or enzymes in a sample (Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017)).
The dependent claims have been analyzed with respect to step 2B and none of these claims provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception.
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 § 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 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.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1-2, 4-6, 9-16, and 232-233 are rejected under pre-AIA 35 U.S.C. 102(b)/102(e) as being anticipated by 2009/0142792 to Robinson et al. (filed 20 June 2008).
Claim 1 is directed to:
A method for scoring a sample, said method comprising: receiving a first dataset associated with a first sample obtained from a first subject, wherein said first dataset comprises quantitative data for at least two markers selected from the group consisting of: apolipoprotein A-I (APOA 1); apolipoprotein C-III (APOC3); calprotectin (heteropolymer of protein subunits S 100A8 and S 100A9); chemokine (C-C motif) ligand 22 (CCL22); chitinase 3-like 1 (cartilage glycoprotein- 39) (CHI3Ll); C-reactive protein, pentraxin-related (CRP); epidermal growth factor (beta- urogastrone) (EGF); intercellular adhesion molecule 1 (ICAM1); ICTP; interleukin 18 (interferon-gamma-inducing factor) (IL18); interleukin 1, beta (ILlB); interleukin 1 receptor antagonist (ILlRN); interleukin 6 (interferon, beta 2) (IL6); interleukin 6 receptor (IL6R); interleukin 8 (IL8); keratan sulfate; leptin (LEP); matrix metallopeptidase 1 (interstitial collagenase) (MMPl); matrix metallopeptidase 3 (stromelysin 1, progelatinase) (MMP3); pyridinoline (PYD); resistin (RETN); serum amyloid A 1 (SAA 1); tumor necrosis factor receptor superfamily, member lA (TNFRSFlA); tumor necrosis factor (ligand) superfamily, member 13b (TNFSF13B, or BAFF); vascular cell adhesion molecule 1 (VCAM 1); and, vascular endothelial growth factor A (VEGFA); and
determining, a first DAI score from said first dataset using an interpretation function, wherein said first DAI score provides a quantitative measure of inflammatory disease activity in said first subject.
The prior art to Robinson et al. discloses a method for scoring a sample [0024]; [0055]; [0101]; [0120]; [0127]; [0129]. Robinson further discloses receiving a dataset from a sample of a subject which includes data from at least two markers [0009]; [0010]; [0040]; [0043]; [0097] from a group consisting of at least two markers from the list as claimed above. Said markers in Robinson et al. include, for example: CRP and ILβ and IL6 [0010]; [0039], meeting the limitation of “at least two”. Robinson et al. further disclose determination of disease activity score using an interpretation function [0034]-[0036].
With respect to claim 2, Robinson et al. disclose various techniques and reagents find use in the diagnostic methods of the present invention. In one embodiment of the invention, blood samples, or samples derived from blood, e.g. plasma, circulating, etc. are assayed for the presence of polypeptides [0043], including ELISA which meet the limitations of the claim herein.
With respect to claim 4, Robinson et al. disclose that the disease score is predictive of a clinical assessment, for example RA [0095].
With respect to claim 5, Robinson et al. disclose that analysis includes predictive function [0097].
With respect to claim 6, Robinson et al. disclose at least swollen joint and tender joint count [0036; Table 1].
With respect to claim 9, Robinson et al. disclose at least swollen joint and tender joint count [0036; Table 1].
With respect to claim 10, Robinson et al. disclose TJC [0036] and the marker at least of IL6 [0039].
With respect to claim 11, Robinson et al. disclose SJC [0036] and the marker at least of IL6 [0039].
With respect to claim 12, Robinson et al. disclose global health [0036] and the marker at least of IL6 [0039].
With respect to claim 13, Robinson et al. disclose linear correlation analysis and LDA at [0018]; 0116].
With respect to claim 14, Robinson et al. disclose sample from two or more profiles from the patient [0103].
With respect to claim 15, Robinson et al. disclose RA and response to therapies [0002]; [0005]; [0024]; [0054].
With respect to claim 16, Robinson et al. disclose said limitations at least at [0054]; [0055].
With respect to claim 19, Robinson et al. disclose RA [0010].
With respect to claim 232, Robinson et al. disclose choosing a therapeutic regime [0006]; [0075]; [0118].
With respect to claim 233, Robinson et al. disclose determining an inflammatory treatment [0118].
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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).
Claims 3 and 17-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over 2009/0142792 to Robinson et al. (filed 20 June 2008), as applied to claims 1 and 14 above and in further view of van der Heijde (Bailliere’s Clinical Rheumatology (1996) Vol. 10, No. 3:435-453).
The prior art to Robinson et al. discloses steps of claims 1 and 14, as disclosed above wherein Robinson et al. teach a method for scoring a sample [0024]; [0055]; [0101]; [0120]; [0127]; [0129]. Robinson further discloses receiving a dataset from a sample of a subject which includes data from at least two markers [0009]; [0010]; [0040]; [0043]; [0097] from a group consisting of at least two markers from the list as claimed above. Said markers in Robinson et al. include, for example: CRP and ILβ and IL6 [0010]; [0039], meeting the limitation of “at least two”. Robinson et al. further disclose determination of disease activity score using an interpretation function [0034]-[0036]. Robinson et al. further discloses sample from two or more profiles from the patient [0103].
Robinson et al. does not specifically disclose steps whereby a Sharp score is utilized for assessment of change in RA disease as in claims 3 and 17-18. However, the prior art to van der Heijde discloses a review of the most commonly used assessment tools for change over time in arthritis patients that includes Sharp scoring. van der Heijde teaches that Sharp scoring is a method measuring damage at specific times as well as progression over time and further that is a well-established method that is widely used (pp.438 and 442-443).
As such, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have included Sharp assessment for scoring RA progression in patients along with disease activity as claimed and as presented in van der Heijde. The prior art to Robinson et al. include assessments of erosions in Table 3 and further teach that “further integration and coupling of antibody analysis with cytokine/chemokine analysis and/or genetic analysis and/or other clinical and laboratory data will provide even greater sensitivity and predictive value for an individual patient progressing to clinically definite RA. Datasets from measurement of antibody, cytokine/chemokine, genetic and other laboratory values will be analyzed to determine the sensitivity and specificity of single and combinations of autoantibody, cytokine/chemokine and genetic markers for predicting subsequent development of RA and/or development of severe RA”, thus providing motivation to include clinical and laboratory data in the assessment of disease [Robinson et al. at [0148].
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.
Claims 1-2, 4-6, 9, 13, and 232-233 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 12-13 of U.S. Patent No. 11,300,575. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to:
(Claim 1) A method for scoring a sample, said method comprising: receiving a first dataset associated with a first sample obtained from a first subject, wherein said first dataset comprises quantitative data for at least two markers selected from the group consisting of: apolipoprotein A-I (APOA 1); apolipoprotein C-III (APOC3); calprotectin (heteropolymer of protein subunits S 100A8 and S 100A9); chemokine (C-C motif) ligand 22 (CCL22); chitinase 3-like 1 (cartilage glycoprotein- 39) (CHI3Ll); C-reactive protein, pentraxin-related (CRP); epidermal growth factor (beta- urogastrone) (EGF); intercellular adhesion molecule 1 (ICAM1); ICTP; interleukin 18 (interferon-gamma-inducing factor) (IL18); interleukin 1, beta (ILlB); interleukin 1 receptor antagonist (ILlRN); interleukin 6 (interferon, beta 2) (IL6); interleukin 6 receptor (IL6R); interleukin 8 (IL8); keratan sulfate; leptin (LEP); matrix metallopeptidase 1 (interstitial collagenase) (MMPl); matrix metallopeptidase 3 (stromelysin 1, progelatinase) (MMP3); pyridinoline (PYD); resistin (RETN); serum amyloid A 1 (SAA 1); tumor necrosis factor receptor superfamily, member lA (TNFRSFlA); tumor necrosis factor (ligand) superfamily, member 13b (TNFSF13B, or BAFF); vascular cell adhesion molecule 1 (VCAM 1); and, vascular endothelial growth factor A (VEGFA); and determining, a first DAI score from said first dataset using an interpretation function, wherein said first DAI score provides a quantitative measure of inflammatory disease activity in said first subject.
Claims of the ‘575 patent are similarity directed to:
(Claim 1) A method for generating protein level data for a first subject comprising: performing at least one immunoassay on a first blood sample from the first subject to generate a first dataset comprising protein level data for at least four protein markers, wherein the at least four protein markers comprise at least four markers selected from chitinase 3-like 1 (cartilage glycoprotein-39) (CHI3L1); C-reactive protein, pentraxin-related (CRP); epidermal growth factor (beta-urogastrone) (EGF); interleukin 6 (interferon, beta 2) (IL6); leptin (LEP); matrix metallopeptidase 1 (interstitial collagenase) (MMP1); matrix metallopeptidase 3 (stromelysin 1, progelatinase) (MMP3); resistin (RETN); serum amyloid A1 (SAA1); tumor necrosis factor receptor superfamily, member 1A (TNFRSF1A); vascular cell adhesion molecule 1 (VCAM1); or, vascular endothelial growth factor A (VEGFA); calculating a disease activity index score for the sample by combining the protein level data, wherein the disease activity index score tracks a clinical disease activity score determined from clinical data of a reference population of confirmed RA patients, wherein the clinical data supplies a clinical assessment comprising at least one of DAS, DAS28, DAS28-ESR, DAS28-CRP, HAQ, mHAQ, MDHAQ, physician global assessment VAS, patient global assessment VAS, pain VAS, fatigue VAS, overall VAS, sleep VAS, SDAI, CDAI, RAPID3, RAPID4, RAPID5, ACR20, ACR50, ACR70, SF-36, RAMRIS, TSS, modified TSS, Larsen, TJC, SJC, and GHA, wherein the disease activity index score=((0.56*sqrt(PTJC)+0.28*sqrt(PSJC)+0.36*log(CRP/106+1)+(0.14*PPGHA)+0.96)*10.53)+1; wherein the tracking of the clinical disease activity score is determined by one or more of analysis of variants (ANOVA), Bayesian networks, boosting and Ada-boosting, bootstrap aggregating or bagging, Classification and Regression Trees (CART), boosted CART, Random Forest (RF), Recursive Partitioning Trees (RPART), Curds and Whey (CW), Curds and Whey-Lasso, principal component analysis (PCA), Linear Discriminant Analysis (LDA), Eigengene Linear Discriminant Analysis (ELDA), Discriminant Function Analysis (DFA), factor rotation, Hidden Markov Models, kernel density estimation, kernel partial least squares, kernel matching pursuit, kernel Fisher's discriminate analysis, kernel principal components analysis, linear regression, Forward Linear Stepwise Regression, LASSO shrinkage and selection, Elastic Net regularization and selection, glmnet (Lasso and Electric Net-regularized generalized linear model), Logistic Regression (LogReg), meta-learner, Kth-nearest neighbor (KNN), non-linear regression, neural networks, partial least square, shrunken centroids (SC), sliced inverse regression, Standard for the Exchange of Product model data, super principal component (SPC) regression, Support Vector Machines (SVM), and Recursive Support Vector Machines (RSVM); diagnosing or prognosing the subject as needing treatment for rheumatoid arthritis (RA) based on the protein level disease activity index score exceeding a reference value of the clinical disease activity score, wherein the diagnosis or prognosis is the same for subjects with and without comorbidities; and administering a therapy to the subjected diagnosed or prognosed as needing treatment, the therapy comprising one or more of administering a therapeutic compound selected from DMARDs, biologic DMARDs, non-steroidal anti-inflammatory drugs (NSAID's), and corticosteroids; and administering bariatric surgical intervention.
The instant claims are not specifically directed to the specific scoring index as claimed in the ‘575 patent. However, looking to the instant Specification for definition of the DAI index score, as is claimed herein, the DAI is disclosed as calculated using the same scoring algorithmic parameters as in ‘575 claim 1 (instant Specification at [0024]). As such, the claims are obvious variants ones of the other.
Conclusion
No claims are allowed.
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/Lori A. Clow/ Primary Examiner, Art Unit 1687