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 .
Election/Restrictions
Applicant's election with traverse of Group III in the reply filed on 1/22/2026 is acknowledged. The traversal is on the grounds that independent claims 1, 9, and 16 have been amended to include the specific technical feature across all groups of: a thermo-polymer containing a plurality of particles encapsulating one or more sequence-controlled polymers, said plurality of particles being homogeneously distributed within the thermo-polymer, and said one or more sequence-controlled encoding (input/output/predetermined) data containing an error correction code. The cited reference to Grass merely teaches encapsulation of DNA as a data carrier in Silica and fails to describe or suggest the special technical features as presently claims, and therefore, there is Unity across all claimed groups.
This is not found persuasive because the technical feature identified in the Restriction mailed 11/26/2025 is “a sequence-controlled polymer comprising an error correction code”, not “a thermo-polymer containing a plurality of particles encapsulating one or more sequence-controlled polymers, said plurality of particles being homogeneously distributed within the thermo-polymer, and said one or more sequence-controlled encoding (input/output/predetermined) data containing an error correction code”, as identified by Applicant (see also Para. [0002] of the instant Specification that discloses “the special technical feature of a sequence controlled polymer comprising data and an error-correction code”). While the technical feature is present across all groups, it is not a special technical feature because Grass et al. (Robust chemical preservation of digital information on DNA in silica with error-correcting codes. Angew Chem Int Ed Engl. 54(8): 2552-5 (2015); previously cited) discloses the technical feature, as described in the Restriction mailed 11/26/2025.
The requirement is still deemed proper and is therefore made FINAL.
Status of the Claims
Claims 16-19 and 21-22 are pending and under consideration in this action. Claims 1-4, 6-12, and 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
Priority
The instant application is 371 of PCT/EP2020/066800, filed 6/17/2020, which claims priority to U.S. Provisional Application number 62/863,516, filed 6/19/2019 as reflected in the filing receipt mailed 8/29/2022. The claim for domestic benefit for claims 16-19 and 21-22 is acknowledged. As such, the effective filing date of claims 16-19 and 21-22 is 6/19/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/16/2021 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Nucleotide sequences appearing in the Specification (Para. [0052]) are not identified by the corresponding sequence identifiers in accordance with 37 CFR 1.821(d).
Nucleotide appearing in the drawings (Fig. 2-3, 4A, 4B, 4C, and 8) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide sequences must appear either in the drawings or in the Brief Description of the Drawings.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see Para. [0106]). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Examiner also notes that the section of the Specification for “Cross-reference to related applications” as described in MPEP § 608.01(a) is missing. Although it is not required, it is suggested to include a reference to the priority of the instant application, as a 371 of PCT/EP2020/066800, which claims priority to U.S. Provisional Application number 62/863,516 (See 37 CFR 1.78 and MPEP § 211).
Drawings
The drawings are objected to because of the following informalities:
In Figures 2 and 8, the DNA sequences in step (b) are blurry and difficult to read.
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.
Claim Objections
Claims 16 and 22 are objected to because of the following informalities:
Claim 16 recites the phrase “a plurality of particles embedded in a thermo-polymer with said plurality of particles being homegenuously distributed within the thermo-polymer”, which should be corrected to “a plurality of particles embedded in a thermo-polymer with said plurality of particles being homogeneously distributed within the thermo-polymer” to correct the spelling for clarity.
Claim 22 recites the phrase “the thermo-polymer comprises polycaprolactone (PCL), polymethylmethacrylate (PMMA), polylactic acid (PLA), acrylonitrile butadien styrene (ABS) or poly(lactic-coglycolic acid) (PLGA) or a combination thereof”, which should be corrected to “the thermo-polymer comprises polycaprolactone (PCL), polymethylmethacrylate (PMMA), polylactic acid (PLA), acrylonitrile butadiene styrene (ABS), or poly(lactic-coglycolic acid) (PLGA), or a combination thereof” to include the appropriate commas and correct the spelling for clarity.
Claims 16 and 22 also contains bullet points, which should be corrected to remove the bullet points, as it is not standard U.S. practice.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 16-19 and 21-22 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.
Claim 16 recites the phrase “a data storage medium comprising a plurality of particles embedded in a thermo-polymer with said plurality of particles being homogeneously distributed within the thermo-polymer” in lines 1-2 of the claim. The metes and bounds of the claim are rendered indefinite due to the lack of clarity. The Specification (see at least Para. [0025]]) discloses that DNA molecules are encapsulated in silica beads and then fused into a filament containing a thermo-polymer. The filament is then used as a 3D printing feedstock to create objects with embedded data. The Specification (see at least Para. [0095]) also discloses that the invention may be embodied as a system, a method, and/or a computer program product. The computer program product may include a computer readable storage medium having computer readable program instructions thereon for causing a processor to carry out aspects of the present disclosure. Based on the disclosure, it appears that the claim is directed towards the physical material, however, the “storage medium” could also be interpreted as computer-implemented. Therefore, it is unclear which storage medium the claim is referring to, and clarification through clearer claim language is respectfully requested. Claims 17-19 and 21-22 are also rejected due to their dependency from claim 16.
Regarding claim 22, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
1. Claims 16-18 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Grass et al. (Robust Chemical Preservation of Digital Information on DNA in Silica with Error-Correcting Codes. Angew. Chem. Int. Ed. 54: 2552-2555 (2015); published 2/4/2015; cited in the IDS dated 12/16/2021) in view of Kyratsis et al. (Investigation of the Mechanical Properties of Acrylonitrile Butadiene Styrene (ABS)-Nanosilica Reinforced Nanocomposites for Fused Filament Fabrication 3D Printing. IOP Conf. Ser.: Mater. Sci. Eng. 416: 012086 (2018); published 3/2018).
Regarding claim 16, Grass et al. teaches a method for storing digital information on DNA by encapsulating DNA in an inorganic matrix and employing error-correcting codes to correct storage-related errors (i.e., a data storage medium) (Abstract). Grass et al. further teaches that they translated 83 kB of information to 4991 DNA segments, each 158 nucleotides long, which were encapsulated in silica (i.e., wherein one or more sequence controlled polymer are encapsulated in said plurality of particles) (Abstract). Grass et al. further teaches the process of encoding text to DNA by Reed-Solomon coding. Two letters of a text file (or more general, two bytes of a digital file) are mapped to three elements of the Galois Field of size 47 (GF(47)) by base conversion (2562 to 473). This original information is arranged in blocks of 594x39 elements. In an outer encoding step Reed–Solomon (RS) codes are employed to add redundancy A to the individual blocks. To each column an index is added and redundancy B is generated using a second (inner) RS encoding step. The individual columns are converted into DNA by mapping every element of GF(47) to three nucleotides by utilizing the GF(47) to DNA codon wheel, thereby guaranteeing that no base is repeated more than three times (i.e., wherein said one or more sequence controlled polymer encodes predetermined data) (Pg. 2553, Fig. 1). Grass et al. further teaches that to account for the specific requirements of storage on DNA the existing data coding schemes had to be adapted: Individual sequences are indexed and two independent error-correcting codes (specifically Reed–Solomon codes) are used in a concatenated fashion (i.e., wherein said predetermined data comprise an error correction code) (Pg. 2553, Col. 1, Para. 1). Grass et al. further teaches that to physically test the code they stored the text from two old documents: the Swiss Federal Charter from 1291 and the English translation of the Method of Archimedes. The (uncompressed) total text is 83 kilobytes large, and was encoded as shown in Figure 1. This resulted in 4991 sequences, each 117 nucleotides long to which constant primers were added (giving a total length of 158 nucleotides) to allow for a rapid and indexed library preparation for sequencing (i.e., wherein said predetermined data comprise a payload) (Pg. 2553, Col. 1, Para. 2 – Col. 2, Para. 1 and Pg. 2553, Fig. 1).
Regarding claim 18, Grass et al. teaches the encapsulation the DNA in silica (i.e., wherein the one or more sequence-controlled polymer comprise DNA) (Abstract).
Regarding claim 21, Grass et al. teaches that to account for the specific requirements of storage on DNA the existing data coding schemes had to be adapted: Individual sequences are indexed and two independent error-correcting codes (specifically Reed–Solomon codes) are used in a concatenated fashion (i.e., wherein the error correction code comprises at least one of a DNA Fountain and a Reed-Solomon code) (Pg. 2553, Col. 1, Para. 1).
Grass et al. does not teach a plurality of particles embedded in a thermo-polymer with said plurality of particles being homogeneously distributed within the thermo-polymer (claim 16); having a predetermined shape, wherein the predetermined data comprises a 3D model of the predetermined shape (claim 17); and wherein the plurality of particles comprises silica beads, preferably with a diameter of at most 1000nm; and/or the plurality of particles have a concentration of at most 100mg/kg within the thermo-polymer; and/or the plurality of particles have a concentration of at most 2mg/g of DNA; and/or the thermo-polymer comprises polycaprolactone (PCL), polymethylmethacrylate (PMMA), polylactic acid (PLA), acrylonitrile butadiene styrene (ABS) or poly(lactic-coglycolic acid) (PLGA) or a combination thereof (claim 22).
Regarding claim 16, Kyratsis et al. teaches a method to expand the capabilities of 3D printed structures generated from commercial thermoplastic printers through fabrication of polymer filaments that contain inorganic nanoparticles. Nanosilica was dispersed ultrasonically into acrylonitrile butadiene styrene (ABS) and extruded into filaments for fused filament fabrication 3D printing. The filaments show homogeneously dispersed nanosilica particles (i.e., a plurality of particles embedded in a thermo-polymer with said plurality of particles being homogeneously distributed within the thermo-polymer) (Abstract and Pg. 2, Fig. 1).
Regarding claim 17, Kyratsis et al. teaches that nanosilica particles of 14nm in diameter with concentrations of 5 and 10%wt were dispersed in diluted in acetone ABS over 30 minutes at room temperature in a probe sonicator. The 5%wt nanosilica reinforced ABS filaments provided good 3D prints (i.e., having a predetermined shape, wherein the predetermined data comprises a 3D model of the predetermined shape) (Pg. 2, Para. 4).
Regarding claim 22, Kyratsis et al. teaches that the nanosilica beads were 14 nm in diameter (i.e., wherein the plurality of particles comprise silica beads, preferably with a diameter of at most 1000 nm) (Pg. 2, Para. 4). Kyratsis et al. further teaches that the thermo-polymer is Acrylonitrile Butadiene Styrene (ABS), which is a made by polymerizing styrene and acrylonitrile in the presence of polybutadiene (i.e., wherein the thermo-polymer comprises acrylonitrile butadiene styrene (ABS)) (Pg. 2, Para. 4).
Therefore, regarding claims 16-18 and 21-22, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of DNA storage in silica of Grass et al. by embedding the silica in thermo-polymers, as described by Kyratsis et al. because solid-state DNA storage technologies (e.g., in silica or polymers) significantly decrease the DNA decay rates (Grass et al., Pg. 2554, Col. 1, Para. 1). One of ordinary skill in the art would be able to combine the teachings of Grass et al. with Kyratsis et al. with reasonable expectation of success due to the same nature of the problem to be solved, since both incorporate a method for particle embedding. Therefore, regarding claims 16-18 and 21-22, the instant invention is prima facie obvious (MPEP § 2142).
2. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Grass et al. in view of Kyratsis et al. as applied to claims 16-18 and 21-22 above, and further in view of Erlich et al. (DNA Fountain enables a robust and efficient storage architecture. Science 355: 950-954 (2017); published 3/3/2017; cited in the IDS dated 12/16/2021).
Grass et al. in view of Kyratsis et al., as applied to claims 16-18 and 21-22 above, does not teach wherein the error correction code comprises a fountain code.
Regarding claim 19, Erlich et al. teaches a DNA storage strategy called DNA Fountain, that is highly robust and approaches the information capacity per nucleotide (Abstract). Erlich et al. further teaches a comparison of DNA coding schemes and associated error correction schemes, including DNA Fountain and Reed-Solomon (i.e., wherein the error correction code comprises a fountain code) (Pg. 1, Table 1).
Therefore, regarding claim 19, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the DNA storage method of Grass et al. in view of Kyratsis et al. with the error correction code of Erlich et al. because the method of Erlich et al. improves the storage capacity by orders of magnitude compared to the previous methodology of using Reed-Solomon code as described by Grass et al. (Erlich et al., Abstract and Pg. 1, Col. 3, Para. 2). One of ordinary skill in the art would be able to combine the teachings of Grass et al. in view of Kyratsis et al. with Erlich et al. with reasonable expectation of success due to the same nature of the problem to be solved, since both incorporate an error correction code for DNA storage. Therefore, regarding claim 19, the instant invention is prima facie obvious (MPEP § 2142).
Conclusion
No claims allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANA P SANFORD whose telephone number is (571)272-6504. The examiner can normally be reached Mon-Fri 8am-5pm EST.
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/D.P.S./Examiner, Art Unit 1687
/Lori A. Clow/Primary Examiner, Art Unit 1687
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