DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 25 February 2026 has been entered. Claims 1-20 have been examined.
Pertinent Prior Art
Prior art that is considered pertinent to applicant's disclosure but not relied upon:
20020095585
Par. 46, 65, 133
“…more sensitive information can be partitioned from less sensitive information. Thus, if desired, a participant can maintain more controlled custodial control of information considered sensitive by the participant…”,
“Levels of access to the group information and functions can be made to depend on the level of access the participant provides to her personal genomic profile”
“…requests for [genomic profile] information can be denied if not authorized…”
20040260952
Abstract
“To maintain access security, the subsystem allows a given user to grant to another only those access rights that are equal to or more restrictive than the given users rights.”
20080276296
Par. 36
“An ‘unauthorized authorization’ is an authorization that exists on an end system, but which has not been assigned by either a role-based mechanism…”
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 includes “prevent, pursuant to a first role assigned to a first user, the first user from… being assigned a second role that permits access to the contact information of the individuals…” This means that because the first role is assigned to the first user, the first user is blocked from being assigned the second role. Note that the limitation explicitly requires that it is the assignment of first role itself that provides the restriction.
The remarks state that “Support for the amendments and additions to the claims can be found in Applicant's specification, claims, and drawings, as filed (e.g., at Paragraph [0025] and Claims 1 and 3).” Examiner respectfully disagrees.
Par. 25 of the specification includes “measures are taken to protect the individuals’ privacy and segregate the types of information researchers/investigators can access” and “users of the system (e.g., researchers and investigators) are prevented from looking up the personal information of a particular individual” but there is no mention of blocking of a second role assignment pursuant to (i.e. because of, or in response to) an assigned first role. Additionally, par. 40 of the specification includes “For example, designating the same user account as both an investigator and a researcher. Such a designation, therefore, should be prohibited and/or brought to the attention of the administrator” but there is no mention of prohibition of a second role assignment pursuant to (i.e. because of, or in response to) an assigned first role. In stark contrast to what is being claimed, the sentence “Such a designation, therefore, should be prohibited and/or brought to the attention of the administrator” (with emphasis added) encompasses actually designating a user account as both roles and notifying an administrator upon occurrence of such a dual role designation.
Original claims 1 and 3 include “prevent, pursuant to a first role assigned to a first user, the first user from accessing contact information associated with the individuals in the cohort” and “in response to the first user requesting to be designated a second role that permits access to the contact information of the of the previously genotyped individuals: prohibit the designation of the second role; and issue an alert to a second user having an administrator role that such a designation was requested.” None of these limitations require that because the first role is assigned to the first user, the first user is blocked from being assigned the second role. Note that in original claim 3, prohibiting the designation of a second role is in response (i.e. pursuant) to the first user requesting the designation, not pursuant to a first role assigned to the first user.
Claims 2-20 are likewise rejected for including the same or similar subject matter or for being respective dependent claims.
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 1-6, 8-18 and 20 of U.S. Patent No. 11748383 (‘383), application serial number 17247539, in view of in view of Belouchi et al., Pub. No.: US 20090305900 A1, (hereinafter Belouchi). Claims 1, 12 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15 and 16 of US Patent No.: 8990250 (‘250), application serial number 13270429, in view of in view of Belouchi. Although the claims at issue are not identical, they are not patentably distinct from each other as shown below.
All limitations and elements in claims 1-20 of the instant application are found in claims 1-6, 8-18 and 20 of the ‘383 patent except for “apply one or more filtering criteria to the candidate group to remove individuals from the candidate group who are genetically related to at least one other individual in the candidate group” and the language “…comprises removing immediate family members from the candidate group based on the family history” as recited in dependent claims 5 and 17 of the instant application, “…comprises comparing the genetic characteristic information of the individuals in the candidate group with one another” as recited in dependent claims 7 and 19 of the instant application, and the language of dependent claim 8 as amended. However, Belouchi, in the field of genomics, teaches these limitations (par. 199, see at least last two sentences).
All limitations and elements of independent claims 1, 12 and 13 of the instant application are found in claims 1, 9, 15, 16 of the ‘250 patent except for “apply one or more filtering criteria to the candidate group to remove individuals from the candidate group who are genetically related to at least one other individual in the candidate group” as recited in independent claims 1, 12, 13 of the instant application, and the language of dependent claim 8 as amended. However, Belouchi, in the field of genomics, teaches these limitations (par. 199, see at least last two sentences).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, with the teachings of Belouchi and any of the ‘383, and ‘250 patents before them, to modify the candidate group and/or cohort of the ‘383, and ‘250 patents to use algorithms and information from genealogical databases in order to apply a filtering criteria that removes individuals from a candidate group and/or cohort who are genetically related to at least one other individual in the candidate group and/or cohort as taught by Belouchi. One of ordinary skill in the art would be motivated to do so because “Reduced allelic heterogeneity will act to increase relative risk imparted by the remaining alleles and so increase the power of case/control studies to detect genes and trait associated alleles within” a population (Belouchi, par. 199).
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 1, 4-5, 7-8, 10-13, 16-17, and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cookson et al., US 20070192139 A1, hereinafter Cookson, in view of Belouchi and further in view of Ferraiolo et al., A Role-Based Access Control Model and Reference Implementation Within a Corporate Intranet, hereinafter Ferraiolo.
As per claim 1, Cookson discloses A system for assembling a cohort, comprising: one or more processors configured to: search a data storage comprising characteristic information of individuals for whom characteristic information has been previously obtained to identify a candidate group having a genetic characteristic, wherein the characteristic information comprises genetic characteristic information or phenotypic characteristic information (par. 21, 29 wherein the queries correspond to the searching that result in patient cohort reports/cohort groups);
Cookson does not expressly disclose, however Belouchi in the related field of endeavor of genomics discloses apply one or more filtering criteria to the candidate group to remove individuals from the candidate group who are genetically related to at least one other individual in the candidate group (Belouchi par. 199, see at least last two sentences).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the cited references because Belouchi would have allowed Cookson to use algorithms and information from genealogical databases in order to apply a filtering criteria that removes individuals from a candidate group and/or cohort who are genetically related to at least one other individual in the candidate group and/or cohort as taught by Belouchi. One of ordinary skill in the art would be motivated to do so because “Reduced allelic heterogeneity will act to increase relative risk imparted by the remaining alleles and so increase the power of case/control studies to detect genes and trait associated alleles within” a population (Belouchi, par. 199).
assemble the cohort based at least in part on the candidate group (see Cookson as cited above); and
prevent, pursuant to a first role assigned to a first user, the first user from (i) accessing contact information associated with the individuals in the cohort and […] that permits access to the contact information of the individuals, wherein the first role permits access to the characteristic information (Cookson pars. 21, 31, 38 wherein, based on HIPAA/rules/program logic (i.e. first roles), a practitioner/PCP (i.e. first user) is prevented from accessing identifying patient data (i.e. contact information) but is permitted to access all non-patient identifying medical data (i.e. the genetic characteristic information and/or the phenotypic characteristic information of the individuals)).
The combination does not expressly disclose prevent, pursuant to a first role assigned to a first user, the first user from (ii) being assigned a second role. However, Ferraiolo in the related field of endeavor of RBAC discloses this. See Ferraiolo, section 2.4.1 on pages 45-46 which includes “The first constraint, called static separation of duty (SSD), can be used to enforce conflicts of interest policies that may arise as a result of a user gaining authorization for permissions associated with conflicting roles. This means that if a user is authorized as a member of one role, the user is prohibited from being a member of a second role… A user is authorized for a role only if that role is not mutually exclusive with any of the other roles for which the user is already authorized.” Section 3.6.1 on page 61 includes “However, Smith could not be assigned the roles… Billing Clerk or Billing Supervisor because these roles have an SSD relationship with the role AR Supervisor” (i.e. prevent, pursuant to…).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the cited references because Ferraiolo would have allowed the combination to “to enforce conflicts of interest policies that may arise as a result of a user gaining authorization for permissions associated with conflicting roles. This means that if a user is authorized as a member of one role, the user is prohibited from being a member of a second role.”
As per claim 4, Cookson as modified discloses The system of claim 1, wherein the data storage further comprises personal information, wherein the personal information comprises family history or environmental information, and wherein at least a portion of the personal information stored in the data storage was entered by one or more of the individuals (Cookson pars. 28, 31, 32).
As per claim 5, Cookson as modified discloses The system of claim 1, wherein the data storage further comprises personal information, wherein the personal information comprises family history, and wherein applying the one or more filtering criteria to the candidate group to remove individuals from the candidate group who are genetically related to at least one other individual in the candidate group comprises removing immediate family members from the candidate group based on the family history (Belouchi, par. 177, 199. See rationale to combine as provided above).
As per claim 7, Cookson as modified discloses The system of claim 1, wherein applying the one or more filtering criteria to the candidate group to remove individuals from the candidate group who are genetically related to at least one other individual in the candidate group comprises comparing the characteristic information of the individuals in the candidate group with one another (Belouchi, par. 199. See rationale to combine as provided above).
As per claim 8, Cookson as modified discloses The system of claim 1, wherein the contact information associated with the individuals in the cohort comprises names, street addresses, email accounts, Internet accounts, or phone numbers of one or more individuals in the cohort (Cookson, par. 31, 32).
As per claim 10, Cookson as modified discloses the system of claim 1, wherein the one or more processors are further configured to store information pertaining to a research project in association with the individuals in the cohort (see rejection of claim 1 including at least Cookson pars. 6, 21, 23, 29, 52).
As per claim 11, Cookson as modified discloses the system of claim 10, wherein the one or more processors are further configured to assign the first role to the first user based on the research project associated with the individuals in the cohort (see rejection of claim 1 including at least Cookson pars. 6, 21, 23, 29, 52).
As per claims 12, 13, 16-17, and 19, they are analogous to claims above and therefore likewise rejected. See Cookson fig.’s 2-5 for the method and computer program product of claims 12 and 13.
Claims 2 and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cookson as modified above and further in view of Stephan et al., US 20090099789, hereinafter Stephan.
As per claim 2, Cookson as modified discloses The system of claim 1. Cookson as modified does not expressly disclose however Miller in the related field of endeavor of analyzing genotype and phenotype data discloses wherein the characteristic information of the individuals comprises genetic information that was collected from saliva samples of the individuals and genotyped using a DNA microarray (Stephan, par. 13).
Thus, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the teachings of the cited references because Stephan’s teaching would have allowed the combination to efficiently obtain genetic samples. Par. 13 includes “The genomic profile used can be generated and from a genetic sample. A third party can generate the genomic profile, obtain the genetic sample, or both obtain the sample and generate the genomic profile. The genetic sample can be DNA or RNA and obtained from a biological sample selected from the group consisting of: blood, hair, skin, saliva, semen, urine, fecal material, sweat, and buccal sample. The genomic profile can be deposited into a secure database or vault. Furthermore the genomic profile can be a single nucleotide polymorphism profile, and in some embodiments, the genomic profile can comprise truncations, insertions, deletions, or repeats. The genomic profile can be generated by using a high density DNA microarray, RT-PCR, DNA sequencing, or a combination of techniques.”
Analogous claim 14 is likewise rejected.
Claims 3 and 15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cookson as modified above and further in view of Miller et al., US 20060155668, hereinafter Miller.
As per claim 3, Cookson as modified discloses The system of claim 1. Cookson as modified does not expressly disclose however Miller in the related field of endeavor of data privacy discloses wherein the one or more processors are further configured to, in response to the first user requesting to be designated the second role, issue an alert to a second user having an administrator role that such a designation was requested (Miller, pars. 14-17).
Thus, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the teachings of the cited references because Miller’s teaching would have allowed the combination to reject requests for access to patient information and notify/alert concerned persons including a request manager and auditors by means of an audit trail. Par. 7 includes “Among advantages of the invention in one regard, the privacy management platform may therefore permit an HIM or other manager to track, manage and verify privacy compliance activity with respect to any patient requested or provider policy based restrictions on disclosure of medical information … activity may be documented and logged for auditing and other purposes.”
Analogous claim 15 is likewise rejected.
Claims 6 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cookson as modified in view of US 20100070300 A1, hereinafter Anderson.
As per claim 6, Cookson as modified discloses The system of claim 1 wherein the candidate group has the desired characteristic, wherein the desired characteristic is a disease-causing genetic condition, and wherein the one or more processors are further configured to provide information […] regarding treatment of the disease-causing genetic condition (see rejection of claim 1 including at least Cookson pars. 6, 7, 21, 29, 35, 36, 38).
Cookson as modified does not expressly disclose that information is provided to the individuals in the cohort, however, Anderson in the related field of clinical studies discloses this in at least pars. 89, 93, 100.
Thus, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the teachings of the cited references because Anderson’s teaching would have allowed the combination to enable “the patient to have a clear understanding of the disease progression, and their current status, so that they can plan for future expenses, complications, and treatments” (Anderson par. 7).
Claims 9 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cookson as modified in view of US 20020029162 A1, hereinafter Mascarenhas.
As per claim 9, Cookson as modified discloses The system of claim 1. Cookson as modified does not expressly disclose however Mascarenhas in the related field of endeavor of cohort research discloses wherein assembling the cohort comprises administering a survey to individuals in the candidate group, administering to the individuals in the candidate group one or more screening tests, or administering to the individuals in the candidate group one or more laboratory tests (Mascarenhas, par. 184). Thus, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the teachings of the cited references because Mascarenhas would have allowed Cookson as modified to collect data “…from a cohort of 1373 adults (69% female) using two types of online survey questionnaires for each individual. Psychometric data were collected from a timed-response questionnaire, with responses to fifty statements collected on a seven-point scale (Strongly Disagree, Disagree, Somewhat Disagree, Neutral, Somewhat Agree, Agree, Strongly Agree). These statements were selected out of an original inventory of 83 statements, based on a series of beta-tests designed to validate items in the inventory through factor analysis and other conventional methods.” (par. 184). Furthermore, par. 19 includes “The methodology for the technical solution to these problems described hereunder, represents a generic set of procedures for rapidly analyzing complex biological data sets and uncovering novel relationships within them. This innovation is relevant to meeting (a) the general need for new tools to investigate complex systems; and (b) the practical need for shortcuts that will generate useful predictions from complex data, even under the computational constraints of `point-of-use` devices.”
Analogous claim 20 is likewise rejected.
Response to Arguments
Applicant's arguments filed 2 February 2026 have been considered. In view of claim amendments, non-patent literature Ferraiolo et al., A Role-Based Access Control Model and Reference Implementation Within a Corporate Intranet has been applied.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SYED HASAN whose telephone number is (571)270-5008. The examiner can normally be reached M-F 8am - 5 pm.
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/SYED H HASAN/Primary Examiner, Art Unit 2154
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