DETAILED ACTION
This action is responsive to RCE filed on September 17th, 2025.
Claims 1~20 are examined.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/17/25 has been entered.
Response to Arguments
Applicant’s arguments with respect to claims 1~20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1~5, 8~15, and 18~20 are rejected under 35 U.S.C. 103 as being unpatentable over Carey et al. hereinafter Carey (U.S 2013/0096943), and Paillier et al. hereinafter Paillier (U.S 2022/0293222) in view of Coleman et a. hereinafter Coleman (U.S 2009/0094059).
Regarding Claim 1,
Carey taught a system for secure electronic storage and access to genetic code data, comprising:
a genetic code storage computer system in communication with a genetic code database [¶162]; and
a secure access software code executed by the genetic code storage computer system, the secure access software code causing the computer system to execute the steps of:
receiving genetic code data from a data source [¶81, lab extracts the DNA from the sample, then sequences and uploads it. The sequencing machine has incorporated a secure module that enables upload of the sample data into the Gene Cloud];
receiving information relating to a contractual obligation to: (i) preserve confidentiality of an individual to whom the genetic code data corresponds [¶183, researchers and medical personnel to operate on genetic sequences while ensuring confidentiality and privacy for consumers whose data is managed by the Gene Cloud], and
(ii) defining at least one usage right associated with information contained in the genetic code data [¶200, the permissions policies maintained by the Gene Cloud may originate from multiple sources such as, (1) the originator of the data; (2) laws and regulations in force in the geography in which the sequence is collected, processed, or stored; (3) care providers; and/or (4) patient];
processing the genetic code data to produce secure genetic code data [¶49, service securely and privately associates the patient information in a way that cannot readily be inferred by lab personnel; ¶51, genomic data is stored in encrypted form, and is de-coupled from information that would reveal the identity of the individual to which it belongs];
store the secured genetic code data in the genetic code database in communication with the genetic code storage computer system [¶162, secure genetic database 220]; and
maintaining confidentiality of, and enforcing usage of, the secure genetic code data in accordance with the contractual obligation [¶81, lab extracts the DNA from the sample, then sequences and uploads it. The sequencing machine has incorporated a secure module that enables upload of the sample data into the Gene Cloud].
Carey did not specifically teach securely storing at least one annotation relating to the secure genetic code, the at least one annotation defining a relationship between a sequence or a single nucleotide variant of the secure genetic code and a biological feature, the secure genetic code and the at least one annotation securely accessible during the individual's lifetime and usable for healthcare of the individual.
Paillier taught securely storing at least one annotation relating to the secure genetic code [¶10, number of companies develop tools for analysis, annotation and interpretation of these raw sequencing data; ¶98, homomorphic encryption method for securely producing natively encrypted sequencing data],
the at least one annotation defining a relationship between a sequence or a single nucleotide variant of the secure genetic code and a biological feature [¶108, a user's genomic data is provided to a service provider in order to predict a genetic trait or a risk of disease],
the secure genetic code and the at least one annotation securely accessible during the individual's lifetime and usable for healthcare of the individual [¶99, the system allows a user to directly mine his own information. Analyses are secured and new results are transferred encrypted; ¶74~¶76].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention was made, to combine, Paillier’s teaching of limitations with the teachings of Carey, because the combination would provide sequencing revolution paired with emergence of well characterized and clinically-actionable mutations opening the way to personalized medicine and much more [Paillier: ¶3].
Carey-Pailllier did not specifically teach the at least one annotation accessible by a link and providing access to at least one data base storing scientific or medical literature pertinent to the sequence or the single nucleotide variant of the secure genetic code.
Coleman taught the at least one annotation accessible by a link and providing access to at least one data base storing scientific or medical literature pertinent to the sequence or the single nucleotide variant of the secure genetic code [¶84, Pharmacogenomics database 22 include for example correlations between markers for genetic polymorphisms (such as SNPs) and phenotypes, extensive references and annotations from the medical literature, related hyperlinks, drug generic and brand names; ¶92].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention was made, to combine, Coleman’s teaching of limitations with the teachings of Carey and Paillier, because the combination allows the patient or health care provider to better manage ADRs, and encourages use of genetic testing [Coleman: ¶24].
Regarding Claim 2,
Carey taught wherein the genetic code data corresponds to one or more laboratory tests, and the genetic code data is transmitted to the genetic code storage computer system from one or more lab sequencing computer systems in communication with the genetic code storage computer system [¶81, lab extracts the DNA from the sample, then sequences and uploads it].
Regarding Claim 3,
Carey taught wherein the step of processing the genetic code data to produce the secure genetic code data comprises encrypting the genetic code data [¶51, genomic data is stored in encrypted form].
Regarding Claim 4,
Carey taught wherein the step of processing the genetic code data to produce the secure genetic code data includes processing the genetic code data using one or more of biometric information, public-key encryption, or a hash value [¶7, generated digital signature with the encrypted genomic data].
Regarding Claim 5,
Carey taught wherein the secure access software code further causes the computer system to execute the steps of: receiving an access request from an end-user device in communication with the genetic code storage computer system; and authenticating a party requesting access [¶195, sequence data is retrieved, decrypted, and processed in response to search requests and Virtual Diagnostic Test Requests; ¶327, an authenticated principal asks to run a given trusted analysis program on one or more trusted data objects].
Regarding Claim 8,
Carey taught wherein the end-user device comprises one or more of a healthcare provider computer system, a genealogy computer system, or a research computer system [¶67, Gene Cloud system].
Regarding Claim 9,
Carey taught further comprising receiving enhanced genetic information corresponding to the secure genetic code data [¶87, secure module appends important metadata; ¶259].
Regarding Claim 10,
Carey further comprising updating the secure genetic code data with the enhanced genetic information [¶87, secure module appends important metadata; ¶259].
Regarding Claims 11~15 and 18~20, the claims are similar in scope to claims 1~5 and 8~10 and therefore, rejected under the same rationale.
Claims 6, 7, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Carey, Paillier, and Coleman in view of Nelson et al. hereinafter Nelson (U.S 2021/0216928).
Regarding Claim 6,
Carey-Paillier-Coleman-Nelson taught wherein the secure access software code further causes the computer system to execute the steps of denying the access request if the requesting party is not authenticated or providing electronic access to the secured genetic code from the genetic code database if the requesting party is authenticated [¶64, when the secondary user 30 does not have permission to access the sequencing data 14, either a denial notice is provided or certain default profile information is provided].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention was made, to combine, Nelson’s teaching of limitations with the teachings of Carey, Paillier, and Coleman, because the combination would provide controlled transmission or distribution of genomic information may make use of encryption or other known security techniques to prevent unauthorized access by third party, such as hackers [Nelson: ¶80].
Regarding Claim 7,
Carey taught wherein the secure access software code further causes the computer system to decrypt the secured genetic code if the requesting party is authenticated [¶194, description of (f)~(h)].
Regarding Claims 16 and 17, the claims are similar in scope to claims 6 and 7 and therefore, rejected under the same rationale.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEE SOO KIM whose telephone number is (571)270-3229. The examiner can normally be reached M-F 9AM-5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas Taylor can be reached on (571) 272-3889. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HEE SOO KIM/Primary Examiner, Art Unit 2443