DETAILED ACTION
Status of Claims
This action is in reply to the application filed on 13 November, 2024.
Claims 21 – 32 have been cancelled by a preliminary amendment filed on 19 January, 2025.
Claims 1 - 20 are currently pending and have been examined.
This application is a continuation of application number 18/166,251 now US 12,191,023; which is a continuation of application number 16/370,719 now abandoned.
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 .
Claim Interpretation
The claims recite generating a first grouping based on a characterization parameter and genetic information related to an individual. The characterization parameter is determined based on data extracted from a data storage system, and the genetic information is determined by processing a sample provided by the individual. For example, the specification discloses that a first group may be formed of individuals of a particular age (@ 0059 in the specification as published) or having an ICD code in the record (@ 0012) (i.e. a characterization parameter), and that have a particular named gene or gene cluster such as the presence of the BRCA1 gene (i.e. genetic information). The genetic information is determined using known techniques including PCR, DNA sequencing, epigenetic analysis, and RNA sequencing (@ 0012)
The claims generate a second grouping by associating a “screening result” with the first grouping. The “screening result” is based on whether a cell culture shows a therapy induced modulation response by an agent or intervention. A response may include a positive response, no response or a negative response. Therapy induced modulation response is determined using techniques that are disclosed at a high level of generality – i.e. “therapeutic screening” – without any technical details as to how this is performed. (@ 0052) As such, the second grouping includes the first grouping in it’s entirety. The specific screening result is irrelevant with regard to inclusion in the second grouping. Inclusion in the second grouping is required based on having ANY screening result. The first and second grouping are identical.
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.
Claims 1 - 20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Examiner cannot determine the metes and bounds of the claims. In particular, it is unclear how the first and second groupings are generated based on the data for a single individual. Further, it is unclear how the first group differs from the second group since both groups only include “the individual”; and the second group is generated regardless of whether the result indicates that the individual is a responder or non-responder. Claims 1 and 17 require determining or generating information “relating to an individual” (i.e. a characterization parameter, genetic information and a therapy induced modulation in a cell culture), used to generate a first and second “grouping”. Groupings are disclosed as “patient clusters”, or “a grouping of individual patients or a grouping of groups of patients”, or “a first plurality of individuals may be grouped” (0058, 0059). Appropriate correction or clarification is required.
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 17 is representative. Claim 17 recites:
A computer-based method for developing a targeted therapy for an individual, said method comprising:
extracting data relating to an individual from a storage system;
determining a characterization parameter of said individual based on said data;
determining genetic information of said individual from a sample provided by said individual;
generating a first grouping based on one or more of said characterization parameter and said genetic information;
identifying a therapy induced modulation in a cell culture grown from a cell taken from said sample thereby generating a screening result; and
associating said first grouping with said screening result thereby generating a second grouping; and
generating or identifying said targeted therapy based on said second grouping.
Claim 1 recites a computer-based platform that executes the steps of the method recited in Claim 17.
Claims 1 - 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea), and does not include additional elements that either: 1) integrate the abstract idea into a practical application, or 2) that provide an inventive concept – i.e. elements that amount to significantly more than the abstract idea. The Claims are directed to an abstract idea because, when considered as a whole, the plain focus of the claims is on an abstract idea.
STEP 1
The claims are directed to a computer-based platform and method, which are included in the statutory categories of invention.
STEP 2A PRONG ONE
The claims recite the abstract idea of:
generating a first grouping based on one or more of said characterization parameter and said genetic information;
associating said first grouping with said screening result thereby generating a second grouping; and
generating or identifying said targeted therapy based on said second grouping.
The claims, as illustrated by Claim 17, recite an abstract idea within the “certain methods of organizing human activity” grouping –
managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions.
The claims recite collecting information about an individual - i.e. a characterization parameter based on data received relating to the individual, and genetic information. The individual is grouped in a first grouping based on the characterization parameter and the genetic information. For example, the specification discloses that a first group may be formed of individuals of a particular age (@ 0059 - 0060), or having an ICD code in the record (@ 0012) (i.e. a characterization parameter); and that also have a particular named gene or gene cluster such as the presence of the BRCA1 gene (i.e. genetic information). The genetic information is determined using known techniques including PCR, DNA sequencing, epigenetic analysis, and RNA sequencing (@ 0012). Grouping individuals based on information received about the individual comprises “filtering content”, and merely organizes this human activity. (See MPEP 2106.04(a)(2) II C)
The claims further recite collecting a screening result related to a therapy-induced modulation of a cell culture, and generating a second grouping by associating the screening result with the first grouping. The screening result indicates whether the individual is a “responder” or “non-responder” to the therapy being screened. The second grouping may include individuals from the first grouping who are also “responders”. Responding to the therapy at the cellular level is an indication of effectiveness in treating the patient. As above, re-grouping individuals in the first group based on a therapy screening result comprises “filtering content”, and merely organizes this human activity. (See MPEP 2106.04(a)(2) II C)
This type of activity includes conduct that would normally occur when determining whether a therapy will be effective for individuals have certain characteristics. For example, it is routine in medicine to conduct clinical trials on medications and other therapies. Clinical trials generally specify inclusion (and exclusion) criteria for individual participants such as age, gender, diagnosis (i.e. ICD), prescribed medications, etc. The participants are provided with the therapy under study and those that are responders are grouped, allowing the effectiveness of the therapy to be specified for those individuals. As such, the claims recite an abstract idea within the certain methods of organizing human activity grouping.
The claims, as illustrated by Claim 17, recite an abstract idea within the “mental processes” grouping – concepts performed in the human mind including observation, evaluation, judgment and opinion. The claims require grouping an individual based on a characterization parameter and the presence of a gene. The grouping is further subdivided based on the results of the cellular response to a therapy. If the individual’s cell culture responds to the therapy, then the therapy is identified as a targeted therapy. The specification discloses that the characterization parameter and information relative to the presence of a gene is obtained using conventional techniques. For example, the characterization parameter may be the individual’s age, weight, height, gender; any measured, sensed or observed feature or behavior, including a diagnosis represented by an ICD code. Grouping individuals based on two data characteristics, and re-grouping based on a third characteristic is a process that, except for generic computer implementation steps, can be performed in the human mind. As such, the claims recite an abstract idea within the mental process grouping.
STEP 2A PRONG TWO
The claims recite additional elements beyond those that encompass the abstract idea above including:
a computer based method;
extracting data relating to an individual from a storage system;
determining a characterization parameter of said individual based on said data;
determining genetic information of said individual from a sample provided by said individual;
identifying a therapy induced modulation in a cell culture grown from a cell taken from said sample thereby generating a screening result.
However, these additional elements do not integrate the abstract idea into a practical application of that idea in accordance with MPEP 2106.05.
The computer platform is recited at a high level of generality such that it amounts to no more than instructions to apply the abstract idea using a generic computer component. These elements merely add instructions to implement the abstract idea on a computer, and generally link the abstract idea to a particular technological environment. Extracting data to obtain a characterization parameter, obtaining genetic information, and therapy screening techniques to obtain a screening result, and using conventional techniques as described in the specification, are extra-solution activities – i.e. a data gathering step. Nothing in the claim recites a technological improvement, and the specification is silent with respect to these kinds of improvements. A general purpose computer that applies a judicial exception by use of conventional computer functions, as is the case here, does not qualify as a particular machine, nor does the recitation of a generic computer impose meaningful limits in the claimed process. (see Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17 (Fed. Cir. 2014)). As such, the additional elements recited in the claim do not integrate the abstract therapy identification process into a practical application of that process.
STEP 2B
The additional elements identified above do not amount to significantly more than the abstract therapy identification process. Extracting data, for example by accessing data in a database, or receiving a transmission of the data over a network to obtain a characterization parameter; and determining genetic information using conventional sequencing techniques is a well-understood, routine and conventional computer function – i.e. receiving or transmitting data over a network as in Symantec, TLI, OIP and buySAFE. The specification discloses that data may be extracted manually (0055). Similarly, identifying a therapy induced modulation in a cell culture is purely conventional in medicine as in US 8,110,560 B2 to Singh et al. (column 34 line 50 – 65) – “standard pharmaceutical procedures in cell cultures”.
The additional structural elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generic computer structure (i.e. a computer-based platform comprising modules). Each of the above components are disclosed in the specification as being purely conventional and/or known in the industry. Because the specification describes these additional elements in general terms, without describing particulars, Examiner concludes that the claim limitations may be broadly, but reasonably construed, as reciting well-understood, routine and conventional computer components and techniques. The specification describes the elements in a manner that indicates that they are sufficiently well-known that the specification does not need to describe the particulars in order to satisfy U.S.C. 112. Considered as an ordered combination the limitations recited in the claims add nothing that is not already present when the steps are considered individually.
The dependent claims add additional features including:
those that merely serve to further narrow the abstract idea above such as:
further limiting the type of data storage (Claim 2, 19);
further limiting the type of characterization parameters (Claims 3 – 5, 20);
further limiting the techniques for determining genetic information (Claims 6, 7);
further limiting the type of sample and cell culture (Claims 8 – 10, 12, 13);
further limiting the target disease (Claim 11);
further limiting the screening result (Claim 14);
those that recite well-understood, routine and conventional activity or computer functions such as:
user applications on mobile devices for extraction and communication (Claims 15, 16);
those that recite insignificant extra-solution activities, or are an ancillary part of the abstract idea such as:
providing the targeted therapy to the individual (Claim 18).
In particular, Claim 18 recites::
providing said targeted therapy to said individual.
A claim reciting a judicial exception may integrate the exception into a practical application if it also recites additional limitations apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, to meaningfully limit the claim, as described in MPEP 2106.04(d)(2).
In order to qualify as a “treatment” or “prophylaxis”, the claim must affirmatively recite an action that effects a particular treatment or prophylaxis, (i.e. “administering” as compared with merely “prescribing”). Further, the treatment or prophylaxis must be “particular, i.e., specifically identified so that it does not encompass all applications of the judicial exception”. For example, a claim that recites an abstract idea and “administering a suitable medication to a patient” is not particular, and is instead merely instructions to “apply” the exception in a generic way.
Here, the claim does not affirmatively recite such an action. That is “providing” a therapy does not include “administering” the therapy. Additionally, the targeted therapy that is determined and administered is not “particular”. For example, the specification discloses that the treatment policy is “suitable for the patient”. No specific treatments are specifically identified in the claims, nor does the specification disclose any such identified treatments.
The apparatus claims are no different from the method claims in substance. “The equivalence of the method, system and media claims is readily apparent.” “The only difference between the claims is the form in which they were drafted.” (Bancorp). The method claims recite the abstract idea implemented on a generic computer, while the apparatus claims recite generic computer components configured to implement the same idea. Specifically, Claims 1 – 16 merely add the generic hardware noted above that nearly every computer will include. The apparatus claim’s requirement that the same method be performed with a programmed computer does not alter the method’s patentability under U.S.C. 101 (In re Grams). Therefore, the claims are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1 – 10 and 15 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Elton et al.: (US PGPUB 2012/0231959 A1) in view of Singh et al.: (US 8,110,560 B2).
CLAIMS 1 and 17
Elton discloses a personalized medical management system and method that includes the following limitations:
A computer-based method for developing a targeted therapy for an individual; (Elton Abstract, 0007);
said method comprising:
extracting data relating to an individual from a storage system; determining a characterization parameter of said individual based on said data; determining genetic information of said individual from a sample provided by said individual; generating a first grouping based on one or more of said characterization parameter and said genetic information; (Elton 0018, 0019, 0028, 0056, 0065, 0067, 0072, 0073, 0077, 0084, 0098).
Elton discloses a system for assigning (i.e. targeting) a therapy to a patient based on patient information including genetic information and phenotype information (i.e. a characterization parameter). Elton forms cohorts of patients (i.e. a first grouping) for inclusion in a clinical trial based on the genetic and phenotype information using machine learning clustering techniques. Elton asserts that clinical trials “improve the development of new therapies”. Elton receives patient data (i.e. data relating to an individual) and results of tests for mutations in one or more genes in a tissue source derived from the patient, (i.e. determining genetic information of said individual), that has a known effect on one or more treatments. Elton identifies the most appropriate treatment for a patient based on the genetic and phenotype information. Elton uses patterns detected for a population of patients based on the disease, treatment, response and outcome of other patients having disease and the same genetic profile, to predict the response to a treatment based on genetic profile, and identifies targeted therapies based on this correlation.
With respect to the following limitations:
identifying a therapy induced modulation in a cell culture grown from a cell taken from said sample thereby generating a screening result; and associating said first grouping with said screening result thereby generating a second grouping; and generating or identifying said targeted therapy based on said second grouping; (Singh col. 31 line 48 to col. 32 line 19, col. 34 line 50 – 65).
Elton discloses forming (i.e. generating) a cohort of participants for a clinical trial (i.e. a first grouping) based on genetic and phenotype information. Elton does not disclose using cell culture screening results for a therapy to further classify members of the cohort as responders or non-responders. Singh discloses identifying genes that predict drug response, both a positive response and a negative response, based on screening results generated by applying a target therapy to a cell culture taken from a patient. Singh identifies a therapy-induced modulation in the cell culture based on the applied therapy, and formulates a personalized therapy for a patient ( i.e. identifying said targeted therapy) based on the results. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the personalized medical management system of Elton so as to have included identifying patients who are responders and non-responders to a therapy using a screening result indicating a modulation in a cell culture induced by the therapy, in accordance with the teaching of Singh, in order to allow for effective targeting a therapy to a particular patient based on the results of the therapy being applied to a cell culture of the patient.
CLAIM 18
The combination of Elton/Singh discloses the limitations above relative to Claim 17. Additionally, Elton discloses the following limitations:
providing said targeted therapy to said individual; (Elton 0107) – disclosing monitoring treatment outcomes which inherently includes providing the treatment to the patient.
CLAIMS 2 – 8, 19 and 20
The combination of Elton/Singh discloses the limitations above relative to Claims 1 and 17. Additionally, Elton discloses the following limitations:
wherein said data storage platform comprises an electronic health record; (Elton 0023, 0056); - Elton discloses obtaining patient-centric information, i.e. patient data, from electronic health records, patient health records or personal medical history.
wherein said characterization parameter is extracted based on an ICD code; (Elton 0059, 0105); - Elton discloses identifying diagnosis information (a characterization parameter) in the database using ICD-9 codes.
wherein said characterization parameter is extracted based on a record generated by a health care provider; (Elton 0056, 0073, 0079, 0092, 0101); - Elton discloses obtaining patient data from patient records generated by practitioners during a patient visit, imaging systems and diagnostic labs.
wherein said characterization parameter is associated with a biologic sample or cell culture; (Elton 0094, 0095, 0098, 0106). – Elton discloses analyzing changes in the patient’s genome and assessing the impact on prognosis or therapy to determine treatment response.
wherein genetic information is determined using a technique selected from a group consisting of PCR, DNA sequencing, epigenetic analysis, and RNA sequencing; (Elton 0052, 0094 - 0097); - Elton discloses using nucleic acid (RNA and DNA) sequencing including robot assisted genomic labs that use PCR techniques.
wherein said genetic information is determined using a micro-array; (Elton 0095); - Elton discloses array-based sequencing.
wherein said sample is selected from a group consisting of a blood sample, a skin sample, a stool sample, a hair sample, and a urine sample; (Elton 0094); - Elton discloses samples including: “blood, interstitial fluid, other secretions, and any tissue that includes cells”.
CLAIMS 15 and 16
The combination of Elton/Singh discloses the limitations above relative to Claim 1. Additionally, Elton discloses the following limitations:
wherein said data is extracted from said storage system using a user application on a mobile computing device; (Elton 0102);
comprising a user application on a mobile computing device and wherein said extraction module is component of said user application; wherein said user application is configured to provide a communication link between the user application and another user application; (Elton 0102).
Elton discloses a mobile communication device for extracting data about a patient by executing “modules” examiner construes a module as software – i.e. a user application.
CLAIMS 9 and 10
The combination of Elton/Singh discloses the limitations above relative to Claim 1. Additionally, Singh discloses the following limitations:
wherein said cell culture comprises a fibroblast extracted from said sample; wherein said cell culture comprises a stem cell converted from a fibroblast extracted from said sample; (Singh col. 4 line 54 – 60).
Singh discloses cell cultures including fibroblast and their extracts such as stem cells. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the personalized medical management system of Elton so as to have included cultures using fibroblast and stem cells, in accordance with the teaching of Singh, in order to allow for effective targeting a therapy to a particular patient diagnosed with spinal muscular atrophy (SMA).
Claims 11 – 14 are rejected under 35 U.S.C. 103 as being unpatentable over Elton et al.: (US PGPUB 2012/0231959 A1) in view of Singh et al.: (US 8,110,560 B2) in view of Tang-Schomer: (US PGPUB 2019/0105498 A1).
CLAIMS 11 – 14
The combination of Elton/Singh discloses the limitations above relative to Claim 1. With respect to the following limitations:
wherein said targeted therapy is directed to treating epilepsy; (Tang-Schomer 0098, 0113, 0121);
wherein said cell culture comprises a nerve cell and wherein said cell culture is coupled to an electrode configured to generate an electric current that is applied to said nerve cell; wherein said electric current causes said nerve cell to display one or both of a cell culture characterization parameter and a cell culture genetic information; wherein said screening result comprises a modulation of one or both of said cell culture characterization parameter and said cell culture genetic information by an agent or intervention; (Tang-Schomer 0006 – 0008, 0044, 0046, 0047, 0119, 0121 – 0124, 0127, 0128).
Elton discloses screening treatments for diseases using cell cultures. Elton does not expressly disclose treatments for epilepsy. Nor does Elton disclose cultures of nerve cells and the recited electrophysiological techniques. Tang-Schomer discloses a system and method for screening compounds that modulate neuronal cells (i.e. a nerve cell) using a cell culture from an individual patient. Electrical stimulus is applied to the cell culture, and the efficacy or toxicity of a drug is determined to identify a personalized treatment, including for epilepsy. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the personalized medical management system of Elton so as to have included identifying patients who are responders and non-responders to a therapy using a screening result indicating a modulation in a cell culture induced by the therapy, in accordance with the teaching of Singh, in order to allow for effective targeting a therapy to a particular patient based on the results of the therapy being applied to a cell culture of the patient.
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 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5 – 7, 9 – 12 and 17 of U.S. Patent No. 12,191,023 B1. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims recite each of the limitations in the corresponding pending claim as shown in the table below:
Pending Claim Issued Claim
1 1
5 1
8 5
9 6
10 7
11 12
12 9/10
13 11
14 1
17 17
18 17
Pending Claims 2 – 4, 6, 15, 16, 19 and 20 recite limitations that are obvious over the issued claims. For example, Claims 2 – 4, 19 and 20 recite extracting data from an electronic health record generated by a provider based on an ICD code. Claim 6 recites determining genetic information using known techniques. Claims 15 and 16 recite generic computer components and applications. All of the features are well-known and obvious modifications to the issued claims; facts for which Examiner takes Official Notice.
CONCLUSION
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US PGPUB 2009/0169535 A1 to Marth discloses a compound that modulates genomic elements to treat epilepsy.
WO 2003/018839 A1 to McCarthy et al. discloses a system for identifying a cohort of genes related to a disease and for identifying treatments for use in treating the disease.
“A strategy to discover genes that carry multi-allelic or mono-allelic risk for common disease: a cohort allelic sums test (CAST)”; Morganthaler et al.; 2/3/2007 discloses cohorts of patients with particular genetic profiles that are used to determine gene-disease relationships.
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to John A. Pauls whose telephone number is (571) 270-5557. The Examiner can normally be reached on Mon. - Fri. 8:00 - 5:00 Eastern. If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773.
Official replies to this Office action may now be submitted electronically by registered users of the EFS-Web system. Information on EFS-Web tools is available on the Internet at: http://www.uspto.gov/patents/process/file/efs/guidance/index.jsp. An EFS-Web Quick-Start Guide is available at: http://www.uspto.gov/ebc/portal/efs/quick-start.pdf.
Alternatively, official replies to this Office action may still be submitted by any one of fax, mail, or hand delivery. Faxed replies should be directed to the central fax at (571) 273-8300. Mailed replies should be addressed to “Commissioner for Patents, PO Box 1450, Alexandria, VA 22313-1450.” Hand delivered replies should be delivered to the “Customer Service Window, Randolph Building, 401 Dulany Street, Alexandria, VA 22314.”
/JOHN A PAULS/Primary Examiner, Art Unit 3683
Date: 28 January, 2026