DETAILED ACTION
Notice of 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 .
Status of the Claims
Claims 1-11 are pending and examined herein.
No claims are canceled.
Priority
As detailed on the 27 June 2023 filing receipt, the application claims priority as early as 03 August 2020 to EP 20305891.2. At this point in examination, all claims have been interpreted as being accorded this priority date as the effective filing date.
Information Disclosure Statement
Information disclosure statement (IDS) was filed on 02 February 2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the references are being considered by the examiner.
Drawings
The drawings are objected to because of typographical errors: synthesizing misspelled as “synthetizing” (Fig. 1), interval misspelled as “intervalle” (Fig. 2), “crypted” should likely read encrypted (Fig. 2), and “Exemple” should read Example. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
“an subject’s personal genome” should read “a subject’s personal genome” (pg. 2, paragraph [9]),
“third-part” should read “third-party” (pg. 3, paragraph [15]),
“vegetal” should likely read “vegetable” (pg. 7, paragraph [24]),
“eg.g.” should read “e.g.” (pg. 9, paragraph [34]),
“The DNA tag encode information” should read “The DNA tag encodes information” (pg. 12, paragraph [56]), and
“The processing unit then encrypt all the sequences” should read “The processing unit then encrypts all the sequences” (pg. 13, paragraph [58]).
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: the clauses “by at least one processing unit” or “by said at least one processing unit” should be offset by commas similar to “by a DNA synthesiser”.
Appropriate correction is required.
35 USC § 101
A rejection under 35 U.S.C. 101 is not applied because the elements in addition to the abstract ideas, particularly encoding exogenous DNA with metadata including an encryption key, and sequencing the key with the sample for subsequent encryption, do not appear to be conventional in the field of genetic privacy. Similar art, such as Erlich (Nature Reviews Genetics 15: 409-421, 2014; newly cited) teaches encrypting genetic data and distributing a key for decryption(pg. 418, col. 1, third paragraph) such that those without a key cannot decrypt the sequences (pg. 418, col. 2, second paragraph), but not sequencing an encryption key with the metadata, including the key, along with the sample, much less where the metadata may comprise multiple keys, personal information, or sequence of interest information. Similarly, Shi (Nature Reviews Genetics 15: 409-421., 2017; newly cited) teaches cryptographic solutions of DNA privacy, including homomorphic encryption using a key (pg. 68, col. 2, last paragraph) but encoding the sequencing the key on exogenous DNA as metadata. Therefore, at least at Step 2B, these elements are considered unconventional in combination and thus no rejection under 35 USC 101 is applied.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 7, and 9-10
Claims 1, 4, 7, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Weisman (US 20150254912 A1; newly cited) in view of Grass (WO 2019/081145 A1; previously cited on the 02 February 2023 IDS form) and Hossein (IEEE Access 8: 76880-76895, 2020; newly cited).
Claim 1 recites synthesizing, by a DNA synthesizer, an exogenous DNA sequence comprising encoded metadata relating to said subject, said metadata comprising at least an encryption key, said encryption key being unique and associated to said subject.
Weisman teaches generating, by the first computerized entity, at least one DNA based key out of a DNA based encryption key and a DNA based authentication key based on the DNA based token (paragraph [4]).
Claim 1 recites collecting a biological sample of said subject in a sampling material, said sampling material comprising said exogenous DNA sequence. This limitation is interpreted as collecting a sample from the subject which is physically combined with the previously instantiated exogenous DNA comprising metadata.
Grass teaches mixing sequences of encrypted information on synthetic DNA with genomic sequences (pg. 5, fourth paragraph).
Claim 1 recites sequencing, by a DNA sequencer, the DNA of said subject obtained from said biological sample and sequencing, by a DNA sequencer, said exogenous DNA sequence comprising encoded metadata.
Grass teaches simultaneous sequencing of the encrypted information and subject sample (pg. 5, fourth paragraph).
Claim 1 recites creating, by at least one processing unit, a text-based file corresponding to the sequenced genome of the subject, said genome comprising at least one sequence of interest and a text-based file corresponding to the sequenced exogenous DNA sequence comprising encoded metadata comprising at least an encryption key.
Grass teaches alleles being read, identified, and indexed, and a resulting binary key (pg. 19, first paragraph).
Claim 1 recites extracting by means of said least one processing unit the encryption key from said text-based file corresponding to the sequenced exogenous DNA sequence.
Grass teaches an encryption key in the form of DNA (pg. 19, last paragraph).
Claim 1 recites encrypting by said least one processing unit said text-based file corresponding to the sequenced genome of the subject with said encryption key from the previous step associated to said subject, apart from the at least one sequence of interest.
Hossein teaches selective encryption (abstract), where the genome is not entirely encrypted.
Furthermore, Grass teaches the required computer with a processor (paragraph [118]) and a synthesizer as “sequences are subsequently synthesized as synthetic DNA” (pg. 10, third paragraph) by an automated synthesis tool (pg. 19, second paragraph).
Claim 9 teaches a system performing the steps of claim, previously taught by the combination of Grass, Weisman, and Hossein, wherein the system comprises a DNA synthesizer, a DNA sequencer, and a processing unit, where the processing unit is interpreted as a computer with a processor.
Grass teaches the required computer with a processor (paragraph [118]), and sequencer device (pg. 17), and a synthesizer as “sequences are subsequently synthesized as synthetic DNA” (pg. 10, third paragraph) by an automated synthesis tool (pg. 19, second paragraph).
Claim 4 recites including encoding a personal database index identifier associated to said subject within the exogenous DNA sequence.
Weisman teaches encoding a personal identification number (paragraph [57]) and Grass teaches a personal key for an individual (pg. 15, first paragraph).
Claim 7 recites including encoding metadata in the exogenous DNA sequence in the form of a binary code based on the combination of the 4 nucleotide bases A, T, G and C.
Grass teaches synthetic DNA formed from the four natural nucleotides (pg. 1, second paragraph) and binary keys (pg. 19), first paragraph.
Claim 10 recites at least one additional processing unit configured to perform the following steps: converting the metadata comprising at least an encryption key into a binary code based on the combination of the 4 nucleotide bases A, T, G and C so as to obtain a nucleic acid sequence corresponding to said metadata, and transmitting the obtained nucleic acid sequence to the DNA sequencer so as to obtain the exogenous DNA sequence comprising encoded metadata comprising at least said encryption key.
Grass teaches synthetic DNA formed from the four natural nucleotides (pg. 1, second paragraph) and binary keys (pg. 19), first paragraph and sequencing of the encrypted information (pg. 5, fourth paragraph).
Combining Grass, Weisman, and Hossein
An invention would have been obvious to one of ordinary skill in the art if some motivation in the prior art would have led that person to modify prior art reference teachings to arrive at the claimed invention prior to the effective filing date of the invention. One would have been motivated to combine the teachings of Weisman with those of Grass because Weisman teaches a DNA-based encryption key and token, which sequenced together with the sample as described by Grass provides a library with both the sample information and encryption accessible simultaneously as digital information (pg. 20, first paragraph), which adds to the reliability of matching the sequence with the identifying information. Furthermore, Hossein teaches selective encoding, which is desirable because it allows clear, or unencrypted, data where safety is not at risk. Grass, Weisman, and Hossein are all directed to security and encryption of genetic data, and their combination would be expected to succeed. Thus, the combination is prima facie obvious.
Claims 2, 6, and 8
Claims 2, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Weisman om view of Grass and Hossein as applied to claims 1, 4, 7, and 9-10 above and further in view of Ayday (EP 2709028 A1; previously cited on the 02 February 2023 IDS form).
Claim 2 recites said metadata comprise at least a second encryption key and the at least one sequence of interest is encrypted by means of said second encryption key.
Ayday teaches first and second private keys (Fig. 2) and thus is interpreted as two keys.
Claim 6 recites the subject is a patient and including encoding the health record of the subject within the exogenous DNA sequence.
Ayday teaches a patient (abstract) but not clearly a health record. However, Grass teaches encryption of personal data (pg. 1, last paragraph), which is considered to include health data.
Claim 8 recites including encrypting the metadata encoded within the exogenous DNA sequence with a third encryption key.
Ayday teaches first and second private keys (Fig. 2) and thus is interpreted as two keys. Additional keys would provide additional security, duplication of parts – here, additional encryption keys – has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
Combining Grass, Weisman, Hossein, and Ayday
An invention would have been obvious to one of ordinary skill in the art if some motivation in the prior art would have led that person to modify prior art reference teachings to arrive at the claimed invention prior to the effective filing date of the invention. One would have been motivated to combine the teachings of Ayday with those previously combined because Ayday teaches two keys – a public key and a private key – which was previously known as a Paillier cryptosystem (paragraph [34]) where multiple keys provide additional levels of privacy dependent on the parties that need to see the information (Fig. 2). The combined prior art is directed to the shared field of endeavor of genetic privacy and their combination would be expected to succeed. Therefore, the invention is prima facie obvious.
Claims 3 and 11
Claims 3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Weisman om view of Grass and Hossein as applied to claims 1, 4, 7, and 9-10 above and further in view of Titus (Plos Computational Biology 14(9): 16 pgs., 2018; newly cited).
Claim 3 recites the text-based file corresponding to the subject is fragmented in blocks of fixed-length base pairs.
Titus teaches breaking up genetic sequence data into k-mers (pg. 3, last paragraph).
Claim 11 recites said at least one processing unit is further configured to fragment the text-based file corresponding to the sequenced genome of the subject in blocks of fixed-length base pairs.
Titus teaches breaking up genetic sequence data into k-mers (pg. 3, last paragraph).
Combining Grass, Weisman, Hossein, and Titus
An invention would have been obvious to one of ordinary skill in the art if some motivation in the prior art would have led that person to modify prior art reference teachings to arrive at the claimed invention prior to the effective filing date of the invention. One would have been motivated to combine the teachings of Titus with those previously combined, which are directed to encryption of genomic data, because Titus teaches division into k-mers, which are equal length fragments, which is further taught as an established method in the field when analyzing large genomic data sets (pg. 3, last paragraph) and thus would be known to one having ordinary skill in the art. The combined art is directed to the shared field of endeavor of security and encryption of genetic data, and their combination would be expected to succeed. Thus, the combination is prima facie obvious.
Claim 5
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Weisman om view of Grass and Hossein as applied to claims 1, 4, 7, and 9-10 above and further in view of Kar (Proceedings of the New Security Paradigms Workshop, pgs. 110-112, 2018; previously cited on the 02 February 2023 IDS form).
Claim 5 recites including encoding information to identify the at least one sequence of interest within the exogenous DNA sequence.
Kar teaches delimiting sequences and signatures (pg. 111, Section 10), which is interpreted as using the synthetic DNA to indicate sequence regions of interest.
Combining Grass, Weisman, Hossein, and Kar
An invention would have been obvious to one of ordinary skill in the art if some motivation in the prior art would have led that person to modify prior art reference teachings to arrive at the claimed invention prior to the effective filing date of the invention. One would have been motivated to combine the teachings of Kar with those previously combined because Kar teaches sequence-based delimiters, which have the advantages of being stored genetically and being able to be verified by biological methods (pg. 121, col. 1, fourth paragraph). Because the combined art is directed genetic privacy, their combination would be expected to succeed and thus the invention is prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert J Kallal whose telephone number is (571)272-6252. The examiner can normally be reached Monday through Friday 8 AM - 4 PM EST.
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/Robert J. Kallal/Examiner, Art Unit 1685
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