Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
2. This Office Action is issued in response to the claims filed on 04/10/2026.
Claims 21-35 are pending in this Office Action.
Claims 1-20 have been cancelled.
Claims 36-40 have been withdrawn (See Applicant Arguments/Remarks dated 04/10/2026, Restriction Requirement Reply Section).
Priority
3. Acknowledgement is made of Applicant’s priority claim of a division of U.S. Patent Application Serial No. 16/259,434, filed January 28, 2019 (now patented as 11,031,132), which is a continuation of U.S. Patent Application Serial No. 15/258,651 (now patented as 10,223,502), filed September 7, 2016, which is a continuation of U.S. Patent Application Serial No. 13/790,596 (now patented as 9,444,880), filed March 8, 2013, which claims priority from and the benefit of U.S. Provisional Application Serial No. 61/622,763, filed April 11, 2012.
Information Disclosure Statement
4. The information disclosure statements (IDS) filed on 12/19/2023, 01/23/2024, and 12/15/2025 have been considered by the Examiner.
Examiner’s Note
5. In Applicant Arguments/Remarks dated 04/10/2026, claims 36-40 have been withdrawn, but claims filed on 04/10/2026 indicate claims 36-40 as previously presented or currently amended. For clarification, claims 36-40 should be indicated as withdrawn. Appropriate corrections are required.
Claim Rejections - 35 USC § 112
6. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claims 21-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
a. Claim 21 recites “a sequencing device” (line 2) and “the sequence device” (lines 4-5). Claims 22 and 23 recite “the sequencing device” (line 2). Claim 26 recites “the sequence device” (line 4). Claim 27 recites “the sequencing device” (lines 2-3). It is unclear whether “a/the sequence device” and “the sequencing device” are the same or different device. Therefore, claim 21 and its dependent claims 22-29 are rejected under 35 U.S.C. 112 (pre-AIA ), second paragraph. For purpose of examination, the Examiner assumes “a/the sequence device” and “the sequencing device” are the same device.
b. Regarding claim 24, limitation “the sequence analysis data” (line 6) lacks proper antecedent basis and makes the claim ambiguous. Therefore, claim 24 is rejected under 35 U.S.C. 112 (pre-AIA ), second paragraph. For purpose of examination, the Examiner assumes “the sequence analysis data” is ”the sequence analysis of the sequence data.”
c. Regarding claim 25, it recites “the method of claim 24” and “the second device” which lack proper antecedent basis and makes the claim ambiguous. Therefore, claim 25 is rejected under 35 U.S.C. 112 (pre-AIA ), second paragraph. For purpose of examination, the Examiner assumes the claim recites “the computer system of claim 24” and “the second device” as “the plurality of computer systems.”
Claim Rejections - 35 USC § 102
8. The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
9. Claims 21-23 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Carey et al. (US 20130096943 A1), hereinafter “Carey.”
Regarding claim 21, Carey discloses a computer system within a cloud environment coupled to a sequencing device, the computer system comprising: one or more processors configured to: receive sequence data corresponding to a biological sample from the sequence device; and receive instructions to perform local analysis, cloud analysis, or combinations thereof of the sequence data (genomic analysis could be done by a same device hosting sequencing process -Fig. 1A with associated text or by an external device -Figs 1B and 1C with associated text. Note: a system that processes genomic data and sequencing data is a computer system that inherently has at least a processor).
Regarding claim 22, Carey discloses the computer system of claim 21, wherein the local analysis is local to the sequencing device (Fig. 1A with associated text).
Regarding claim 23, Carey discloses the computer system of claim 21, wherein the cloud analysis is remote of the sequencing device (Figs 1B and 1C with associated text).
Claim Rejections - 35 USC § 103
10. 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 of this title, 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 negatived by the manner in which the invention was made.
11. Claims 24-25, 29-33, and 35 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carey et al. (US 20130096943 A1), hereinafter “Carey.”
Regarding claim 24, Carey discloses the computer system of claim 21, wherein the instructions comprise instructions to perform the cloud analysis; and wherein the one or more processors are further configured to: obtain a sequence analysis of the sequence data subsequent to receiving the instructions to perform the cloud analysis (Figs. 1B and 1C with associated text: VDT performs tests using sequence data); and transmit the sequence analysis data to a plurality of computer systems (Carey does not explicitly disclose in Figs. 1B and 1C but Carey discloses in Table 3: Client Permission Setting, VDT Execution performs tests yielding diagnostic results which are returned to healthcare providers who use plurality of computer systems. Table 5: User permissions could be set for others besides healthcare providers).
Therefore, it would have been obvious to person of ordinary skill in the art at the time the invention was made to combine Carey’s teaching in Figs 1B and 1C with Carey’s teachings in Table 3 and Table 5 to have predictable and obvious results of transmitting the sequence analysis data to a plurality of computer systems.
Regarding claim 25, Carey discloses the computer system of claim 24, wherein transmitting the sequence data to the second device comprises transmitting a respective base call subsequent to generating the respective base call (Table 4 and paragraph [0246]: Examples of genetic sequence and attributes include base calls). Therefore, it would have been obvious to person of ordinary skill in the art at the time the invention was made to combine Carey’s teaching in Figs 1B and 1C with Carey’s teachings in paragraph [0246] and Table 4 to have predictable and obvious results of transmitting the sequence data to the second device comprises transmitting a respective base call subsequent to generating the respective base call.
Regarding claim 29, Carey discloses in Figs 1A-1B the computer system of claim 21. Figs. 1A-1C with associated text do not disclose but in a different embodiment, Carey discloses wherein the sequence data comprises base call information (Table 4 and paragraph [0246]: Examples of genetic sequence and attributes include base calls). Therefore, it would have been obvious to person of ordinary skill in the art at the time the invention was made to combine Carey’s teaching in Figs 1B and 1C with Carey’s teachings in Table 4 to have predictable and obvious results of the sequence data comprises base call information.
Regarding claim 30, Carey discloses a computer system within a cloud computing environment, the computer system comprising: one or more processors configured to: receive sequence data corresponding to a biological sample; analyze the sequence data based at least in part on third-party software (Figs 1B and 1C with associated text. VDT-FDA Certified “Virtual Diagnostic Tools is third-party software. Note: a system that processes genomic data and sequencing data is a computer system that inherently has at least a processor).
Figs. 1A-1C with associated text do not disclose but in a different embodiment, Carey discloses transmit the analyzed sequence data (Table 3: Client Permission Setting, VDT Execution performs tests yielding diagnostic results- analyzed sequence data-which are returned to healthcare providers).
Therefore, it would have been obvious to person of ordinary skill in the art at the time the invention was made to combine Carey’s teaching in Figs 1B and 1C with Carey’s teachings in Table 3 to have predictable and obvious results of transmitting the analyzed sequence data.
Regarding claim 31, Carey discloses the computer system of claim 30, wherein the sequence data is received from a sequencing device (Figs. 1B and 1C with associated text).
Regarding claim 32, Carey discloses the computer system of claim 30, wherein the one or more processors are further configured to determine a format for the analyzed sequence data, wherein the analyzed sequence data is transmitted in the format (paragraphs [0226]-[0227]: output format. It is obvious to combine Carey’s teachings in Figs 1B and 1C with Carey’s teachings in paragraphs [0226]-[0227] to have predictable and obvious result of determining a format for the analyzed sequence data, wherein the analyzed sequence data is transmitted in the format).
Regarding claim 33, Carey discloses the computer system of claim 30, wherein the one or more processors are further configured to receive authorization data indicating one or more secondary users authorized to access the analyzed sequence data, wherein the analyzed sequence data is transmitted to the one or more secondary users (Table 3: Client Permission Setting, VDT Execution performs tests yielding diagnostic results which are returned to healthcare providers- secondary users. Table 5: User permissions could be set for others besides healthcare providers. It is obvious to combine Carey’s teachings in Figs 1B and 1C with Carey’s teachings in Table 3 and Table 5 to have predictable and obvious result of receiving authorization data indicating one or more secondary users authorized to access the analyzed sequence data, wherein the analyzed sequence data is transmitted to the one or more secondary users).
Regarding claim 35, Carey discloses the computer system of claim 30, wherein the one or more processors are configured to analyze the sequence data based at least on part on the third-party software by annotation of the sequence data from the third-party software (Fig.17 with associated text: details of tests run on sequence data by VDT-third-party software. The details are forms of annotation. It is obvious to combine Carey’s teachings in Figs 1B and 1C with Carey’s teachings in Fig.17 to have predictable and obvious result of analyze the sequence data based at least on part on the third-party software by annotation of the sequence data from the third-party software).
12. Claim 26-28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carey et al. (US 20130096943 A1), hereinafter “Carey” in view of Clarke (US 20120060165 A1), hereinafter “Clarke.”
Regarding claim 26, Carey discloses the computer system of claim 21, wherein the instructions comprise instructions to perform the local analysis (Fig.1A with associated text). Carey does not explicitly disclose wherein the one or more processors are configured to receive the instructions by: receiving one or more data analysis parameters associated with the sequence device; and determining that the one or more data analysis parameters indicate to perform local analysis, cloud analysis, or combinations thereof.
However, determining a service provider to perform a task based on needed resources for the task and resource capability of the service provider is known in the art Clarke’s teaching is an example (paragraphs [0028]-[0034]). Therefore, it is obvious to combine Carey’s teaching of performing sequence analysis with Clarke’s teaching of determining a service provider to perform a task based on needed resources for the task and resource capability of the service provider to have obvious and predictable result of the one or more processors are configured to receive the instructions by: receiving one or more data analysis parameters associated with the sequence device; and determining that the one or more data analysis parameters indicate to perform local analysis, cloud analysis, or combinations thereof.
Regarding claim 27, Carey and Clarke disclose the computer system of claim 26, wherein the one or more data analysis parameters comprise an amount of computing resources associated with the sequencing device (Clarke, paragraphs [0028]-[0034]).
Regarding claim 28, Carey and Clarke disclose the computer system of claim 26, wherein the one or more data analysis parameters comprise an estimated time for assembling nucleotides associated with the sequence data (a). Carey, Table 4: Examples of genetic sequence and attributes include base calls. Paragraph [0246]: association of sequence data, nucleotides, and base calls. b). Clarke, paragraphs [0028] and [0034]: time constraint. The combination of Carey’s teachings from claim 26 and (a) and Clarke’s teaching in (b) would have an obvious and predictable result of the one or more data analysis parameters comprise an estimated time for assembling nucleotides associated with the sequence data.)
13. Claim 24 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carey et al. (US 20130096943 A1), hereinafter “Carey” in view of Leshkowitz (US 20070161001 A1), hereinafter “Leshkowitz.”
Regarding claim 34, Carey discloses the computer system of claim 30, wherein the one or more processes are configured to analyze the sequence data based at least on part on the third-party software by analysis selected from the group consisting of clinical analysis, sequence assembly analysis (Table 5 and Table 6 with associated text: tests run for research- clinical analysis and tests run based on doctor’s order-sequence assembly analysis). Carey does not explicitly disclose analyzing the sequence data based at least on part on the third-party software by resequencing analysis. However, Leshkowitz discloses resequencing of known DNA sequences effected to detect sequence variations of single nucleotide polymorphisms [(SNPs). Therefore, it is obvious to combine Carey’s teachings of analyzing the sequence data based at least on part on the third-party software including clinical analysis, sequence assembly analysis with Leshkowitz’s teaching of resequencing to have obvious and predictable result of analyze the sequence data based at least on part on the third-party software by analysis selected from the group consisting of clinical analysis, sequence assembly analysis, resequencing analysis, or a combination thereof.
Prior Art of Record
14. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure: see attached PTO-892 Notice of References Cited.
Conclusion
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANH T. LE whose telephone number is (571)270-0279. The examiner can normally be reached on Monday-Friday 8:00 am - 4:30 pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Farid Homayounmehr can be reached on 571-272-3739. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANH T LE/Primary Examiner, Art Unit 2495
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