DETAILED ACTION
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 .
Information Disclosure Statement
The IDS filed 6/29/2022, 3/20/2023 and 7/23/2024 have been considered by the Examiner.
Priority
Priority of PCT/CN/2019/130731 filed 12/31/2019 is acknowledged.
Status of Claims
Amendments to the claims filed 4/14/2026 are acknowledged.
Claims 1-14 are under consideration.
Claim Rejections - 35 USC § 101
The instant rejection is maintained for reasons of record in the Office Action of 1/14/2026 and modified to address amendments filed 4/14/2026.
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.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Step 1: Process, Machine, Manufacture or Composition
Claims 1-8, 10, 11, and 13 are drawn to a method.
Claims 9, 12 and 14 are drawn to a non-transitory computer readable medium.
Step 2A Prong One: Identification of an Abstract Idea
The claim(s) recite(s):
1. aligning genome sequence data of individuals to reference genome data to obtain a mutation result of the genome sequence relative to the reference genome data, as in claims 1 and 10.
This step requires comparing nucleic acid sequence data which can be performed by the human mind and is therefore an abstract idea.
2. partitioning a genome of the species into a plurality of unit regions of biological significance, as in claims 1 and 10.
This step reads on a mental process of identifying biological significance and determining partition points. The step is therefore an abstract idea.
3. generating a plurality of mutant patterns of the plurality of individuals in each unit region by statistically analyzing mutant status for each region based on the mutation result and numbering the mutant patterns to obtain the mutation dictionary, as in claims 1 and 10.
This step recites math by statistically analyzing mutant status. As recited the analyzing can also be performed by the human mind. Numbering can also be performed by the human mind. The step is therefore an abstract idea.
4. wherein the gene mutation dictionary comprises the plurality of unit region of biological significance and a unique index number associated with the regions, each unit region comprising mutant patterns and each mutant pattern having a unique index number, as in claims 1 and 10.
This limitation is drawn to describing how information is organized in the mutation dictionary. Organizing information by mutant region and unique index number can be performed by the human mind and is therefore an abstract idea.
5. aligning obtained genome sequencing data of the specific individual to the gene mutation dictionary to obtain a mutant pattern and an index number of the mutant pattern in each of the plurality of unit region of the specific individual, as in claims 1 and 10.
This step of performing an alignment of sequencing data to other data indexed in a mutant library reads on an abstract idea. Comparing data by alignment to other data is a step that can be performed by the human mind and is therefore an abstract idea.
6. storing the index number of the mutant pattern for each of a plurality of regions, as in claims 1 and 10.
This step can be performed by the human mind, such as a process of thinking and remembering. The step is an abstract idea.
7. comparing mutant pattern and corresponding index number of the mutant pattern in each of the plurality of unit regions at the plurality of time points, as in claim 10.
8. determining that the specific individual has a gene mutation when the mutant pattern and the corresponding index number of the mutant pattern change at the plurality of time points, as in claim 10.
The step reads on an information or data comparison that can be performed by the human mind. Make a determinative decision based on an observation of change between mutant patterns and index number can be performed as a mental process and is therefore an abstract idea.
Dependent claims 2-8, 10, 11, and 13 are further drawn to describing the abstract idea and quantifying the number of regions as being in the tens of thousands. However, the amount of data being analyzed does not take the process steps themselves outside the realm of being abstract ideas. Computations on a lot of data performed mentally, or with paper and pencil, would take considerable time and effort, but that is, of course, the singular purpose of computers and computer networks, to perform large numbers of calculations, via algorithms, rapidly, and without error (assuming no error in user input). Although a general purpose computer can perform calculations at a rate and accuracy that can far outstrip the mental performance of a skilled artisan, the nature of the activity is essentially the same, and constitutes an abstract idea. See Bancorp Serves., L.L. C. v. Sun Life Assur. Co. of Canada (U.S.), 687 F.3d 1266,1278 (Fed. Cir. 2012) (holding that “the fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter”); see also See SiRF Tech., Inc. v. Int’l Trade Comm ’n, 601 F.3d 1319,1333 (Fed. Cir. 2010) (holding that: In order for the addition of a machine to impose a meaningful limit on the scope of a claim, it must play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly, i.e., through the utilization of a computer for performing calculations).
Step 2A Prong Two: Consideration of Practical Application
The claims result in determining an index number associated with a mutation pattern and storing the index number of the mutant pattern for each of the plurality of unit regions of a specific individual. In an alternative embodiment to a mental process, the step of storing an index number may also read on storing in a physical or computer database. However, storing derived indices is an extra-solution activity as well as routine, conventional and well understood, as described in MPEP 2106.05(g). The claims do not recite any additional elements that integrate the abstract idea into a practical application.
This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than
a drafting effort designed to monopolize the exception.
Dependent claims 1-8, 10, 11, and 14 are further drawn to describing the data in the database which is organized by the abstract idea steps and further abstract idea steps describing organizing and analyzing the information.
Step 2B: Consideration of Additional Elements and Significantly More
The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea. The recited additional elements are drawn to:
1. Obtaining genome sequence data of a plurality of individuals of a species and reference genome data of the species.
2. Obtaining genome sequence data of the specific individual, the genome sequencing data comprising a plurality of unit regions of biological significance.
3. Storing the index number of the mutant pattern for each of the plurality of unit regions of the specific individual.
These steps of obtaining information and storing results of an abstract idea, which is the determination of an index, read on extra solution activity of data gathering and storing and selecting a particular data type, as described in MPEP 2106.05(g):
• Mere Data Gathering:
(3) Whether the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015).
• Selecting a particular data source or type of data to be manipulated:
i. Limiting a database index to XML tags, Intellectual Ventures I LLC v. Erie Indem. Co., 850 F.3d at 1328-29, 121 USPQ2d at 1937
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because receiving genomic data is a process of data transmission is well known, routine and conventional.
Other elements of the method include a non-transitory computer readable storage medium (claims 9, 12 and 13) which is a recitation of generic computer structure that serves to perform generic computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry. Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed 4/14/2026 have been fully considered but they are not persuasive.
Applicants argue (Remarks, page 6, paragraph 6) that the claim no longer focusses on the creation of a dictionary but instead on a concrete data storage and compression technique that materially changes how genomic data are represented.
In response, Applicant’s arguments are not reflected by limitations in the claims. The claims do not recite data compression steps. Instead the claims are drawn to creating an index to represent genomic regions and storing that index. The data itself is not compressed. Furthermore, even should the data of represented genomic regions be directly compressed, compression per se may also be drawn to an abstract idea depending on the algorithm for compressing. Converting one form of information to another corresponds to concepts identified as abstract ideas by the Courts. Digitech Image Technologies., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014) states that “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.” Furthermore, like the processes claimed in Gottschalk v. Benson, 409 U.S. 63, 175 U.S.P.Q. 673 (1972), the claimed process “can be carried out in existing computers long in use, no new machinery being necessary.”
Applicants argue (Remarks, page 7, par. 1) that the instant claims provide a practical application by changing the manner in which genomic information is encoded and stored in memory.
In response, substituting genomic information with an index value is an abstract idea. The process can be performed mentally or with mathematics that assign a value to genomic sequences. While the process results in an abbreviated representation of information, the process is akin to filtering information and does not improve how the computer functions. Furthermore, the claims do not recite any additional elements that integrate the abstract idea into a practical application, e.g. an additional element that uses the judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim or effects a transformation or reduction of a particular article to a different state or thing. Categories of practical application are listed above under Step 2A Prong Two.
Applicants argue (Remarks, page 7, par. 2) that the method depends on large-scale statistical analysis of mutation types across a plurality of individuals as illustrated in Example 1.
In response, statistical analysis is a mathematical concept. The volume of information subjected to mathematical analysis does not change the nature of the analysis which is math. The claims do not recite any additional elements such as computer data structures that would allow for the management of large volumes of data and therefore such additional elements can not be considered with the claims, which are examined using Broadest Reasonable Interpretation (BRI).
Applicants argue (Remarks, page 7, par. 3) that under Step 2B that ordered the combination of steps including large scale genomic data constructing of mutation type patterns and storing individual genomic mutation information which provides a non-conventional and non-generic solution to the problem of storing massive genomic datasets.
In response, a review of the claimed steps reveals embodiments that are additional elements which include obtaining genomic sequences and storing an index value. These additional elements are drawn to data gathering and outputting which are extra solution activities as described in MPEP2106.05(g).
For the reasons set forth above, the 35 USC rejection is maintained.
Claim Rejections - 35 USC § 103
The rejection of claims 1-6 and 9-14 under 35 U.S.C. 103(a) as being unpatentable over Kimura (US 2017/0017717; IDS filed 3/20/2023) in view of Trakadis (US 2014/0310215) is withdrawn in view of Amendments filed 4/14/2026.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Skibinsky whose telephone number is (571) 272-4373. The examiner can normally be reached on 12 pm - 8:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Ram Shukla can be reached on (571) 272-7035. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anna Skibinsky/
Primary Examiner, AU 1635
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