DETAILED ACTION
Status of Claims
This action is in reply to the communication filed on 27 May, 2026.
Claims 1 – 20 have been cancelled.
Claim 33 – 52 have been added.
Claims 33 - 52 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 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 33 is representative. Claim 33 recites:
A process for targeting a therapy to a subgroup of individuals having a health-related condition, abnormality, or disease, the process comprising:
determining respective characterization parameters for individuals based at least in part on data relating to the individuals extracted from computer storage;
determining genetic information for the individuals based on respective biological samples obtained or derived from the individuals;
generating first data representing a first grouping of the individuals,
wherein the individuals in the first grouping have the health-related condition, abnormality, or disease, and
wherein the first grouping includes individuals who share one or more of the characterization parameters and one or more of the genetic information;
applying a stimulation to respective cell cultures grown from cells taken from respective biological samples obtained or derived from selected individuals in the first grouping;
measuring any respective modulation in the respective cell cultures caused by the stimulation to a cell culture characterization parameter or cell culture genetic information, thereby generating respective in vitro screening results for the biological samples obtained or derived from selected individuals in the first grouping;
generating data representing a second grouping of the individuals, such that the second grouping includes individuals from the first grouping who further share one or more of a cell culture characterization parameter or cell culture genetic information correlated with the respective in vitro screening results indicating the individuals in the second grouping are predicted to respond to the therapy; and
identifying a candidate individual for receiving the therapy, the candidate individual sharing the one or more of the characterization parameters and the one or more of the genetic information with the individuals in the first grouping and who further shares the one or more of the cell culture characterization parameter or cell culture genetic information with the individuals in the second grouping.
Claim 45 recites similar limitations, excluding the initial “determining” steps.
Claims 33 - 52 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 process and a method, which are included in the statutory categories of invention.
STEP 2A PRONG ONE
The claims recite the abstract idea of:
generating first data representing a first grouping of the individuals,
wherein the individuals in the first grouping have the health-related condition, abnormality, or disease, and
wherein the first grouping includes individuals who share one or more of the characterization parameters and one or more of the genetic information;
generating data representing a second grouping of the individuals, such that the second grouping includes individuals from the first grouping who further share one or more of a cell culture characterization parameter or cell culture genetic information correlated with the respective in vitro screening results indicating the individuals in the second grouping are predicted to respond to the therapy; and
identifying a candidate individual for receiving the therapy, the candidate individual sharing the one or more of the characterization parameters and the one or more of the genetic information with the individuals in the first grouping and who further shares the one or more of the cell culture characterization parameter or cell culture genetic information with the individuals in the 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:
determining respective characterization parameters for individuals based at least in part on data relating to the individuals extracted from computer storage;
determining genetic information for the individuals based on respective biological samples obtained or derived from the individuals;
applying a stimulation to respective cell cultures grown from cells taken from respective biological samples obtained or derived from selected individuals in the first grouping; measuring any respective modulation in the respective cell cultures caused by the stimulation to a cell culture characterization parameter or cell culture genetic information, thereby generating respective in vitro screening results for the biological samples obtained or derived from selected individuals in the first grouping;
However, these additional elements do not integrate the abstract idea into a practical application of that idea in accordance with MPEP 2106.05.
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 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 43);
further limiting the type of characterization parameters (Claim 42, 52);
further limiting the techniques for determining genetic information (Claim 44);
further limiting the type of sample and cell culture (Claims 34 – 36, 46 - 48);
further limiting the target disease (Claim 40);
further limiting the type of biological sample; (Claim 37);
those that recite well-understood, routine and conventional activity or computer functions such as:
stimulating cell cultures by applying an electric current; (Claim 38, 39, 49, 50);
stimulating cell cultures by exposing to a compound; (Claim 41, 51).
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 33 – 35, 37, 41 – 47, 51 and 52 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 33 and 45
Elton discloses a personalized medical management system and method that includes the following limitations:
A process for targeting a therapy to a subgroup of individuals having a health related condition, abnormality, or disease; (Elton Abstract, 0007);
the process comprising:
determining respective characterization parameters for individuals based at least in part on data relating to the individuals extracted from computer storage; determining genetic information for the individuals based on respective biological samples obtained or derived from the individuals; generating first data representing a first grouping of the individuals, wherein the individuals in the first grouping have the health-related condition, abnormality, or disease, and wherein the first grouping includes individuals who share one or more of the characterization parameters and one or more of the 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:
applying a stimulation to respective cell cultures grown from cells taken from respective biological samples obtained or derived from selected individuals in the first grouping; measuring any respective modulation in the respective cell cultures caused by the stimulation to a cell culture characterization parameter or cell culture genetic information, thereby generating respective in vitro screening results for the biological samples obtained or derived from selected individuals in the first grouping; generating data representing a second grouping of the individuals, such that the second grouping includes individuals from the first grouping who further share one or more of a cell culture characterization parameter or cell culture genetic information correlated with the respective in vitro screening results indicating the individuals in the second grouping are predicted to respond to the therapy; and identifying a candidate individual for receiving the therapy, the candidate individual sharing the one or more of the characterization parameters and the one or more of the genetic information with the individuals in the first grouping and who further shares the one or more of the cell culture characterization parameter or cell culture genetic information with the individuals in the 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.
CLAIMS 34, 35, 41, 42, 46 and 47
The combination of Elton/Singh discloses the limitations above relative to Claims 33 and 45. Additionally, Singh discloses the following limitations:
wherein the cell culture include fibroblasts extracted from the respective biological samples; wherein the cell cultures include stem cells derived from fibroblasts extracted from the respective biological samples; (Singh col. 4 line 54 – 60);
wherein applying the stimulation comprises exposing respective cell cultures to one or more compounds; wherein the characterization parameter modulated by the stimulation includes one or more of cell count, cell density, growth rate, metabolic properties, response to a stimulus, or response to a therapeutic; (Singh col. 31 line 48 to col. 32 line 19, col. 34 line 50 – 65).
Singh discloses cell cultures including fibroblast and their extracts such as stem cells. 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. 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 37, 43, 44
The combination of Elton/Singh discloses the limitations above relative to Claim 33. Additionally, Elton discloses the following limitations:
wherein the respective biological samples includes samples selected from the 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”.
wherein said data storage platform comprises an electronic health record; (Elton 0023, 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, including patient health records or personal medical history.
wherein determining genetic information for the individuals comprises performing any 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.
Claims 36, 38 – 40 and 48 - 50 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 36, 38 – 40 and 48 - 50
The combination of Elton/Singh discloses the limitations above relative to Claims 33 and 45. With respect to the following limitations:
wherein the cell cultures include nerve cells; wherein applying the stimulation to the cell cultures comprises applying an electric current; wherein the electric current causes the cells to display the respective modulation of the characterization parameter or the genetic information; (Tang-Schomer 0006 – 0008, 0044, 0046, 0047, 0119, 0121 – 0124, 0127, 0128);
wherein said targeted therapy is directed to treating epilepsy; (Tang-Schomer 0098, 0113, 0121).
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 33 - 52 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
33/45 1
34/46 6
35/47 7
36/48 9
37 5
38/49 10
39/50 11
40 12
41 13
42 14
Pending Claims 43 and 44 recite limitations that are obvious over the issued claims. For example, Claim 43 recite extracting data from an electronic health record. Claim 44 recites determining genetic information using known techniques. All of the features are well-known and obvious modifications to the issued claims; facts for which Examiner takes Official Notice.
Response to Arguments
Applicant has cancelled all pending claims and added all new claims. Applicant asserts that these new claims are patent eligible under U.S.C. 101; are patentably distinct from the art of record; and distinct from the parent patent. Applicant does not attempt to point out the patentable novelty or eligibility of the newly added claims. Examiner disagrees that the claims are patent eligible or novel/non-obvious over the prior art as shown above.
CONCLUSION
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US PGPUB 2016/0180041 A1 to Pestian et al. discloses a system and method for identifying epilepsy treatment candidates based on dividing a patient population into two groups based on whether they are responders on non-responders to a treatment.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry 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: 11 August, 2026
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