DETAILED CORRESPONDENCE
Application Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicants’ amendment to the claims filed on 01/27/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
3. Claims 1-2, 26-30, 32-34, and 36-44 are pending.
Election/Restrictions
4. Applicant’s election without traverse of Group II, claims 26-30 and 32-33 in the reply filed on 01/27/2026 is acknowledged.
5. Claims 1-2, 34, and 36-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/27/2026.
Claims 26-30 and 32-33 are pending and examined on the merits.
Priority
6. Acknowledgement is made of applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d) to Great Britain Patent Application No. GB2017751.5, filing date 11/10/2020. The certified copy has been filed in the present application, filed on 0509/2023.
Information Disclosure Statement
7. The IDS filed on 01/12/2024 has been considered by the examiner and a copy of the Form PTO/SB/08 is attached to the office action.
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:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. See Figure 1.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112(b)
8. 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.
9. Claims 29-30 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.
The term "about" in claims 29-30 is a relative term which renders the claim indefinite. The term "about" is a term of degree and the examiner has reviewed the specification and can find no examples or teachings that can be used for ascertaining the variance intended by the recited term of degree. Moreover, there is nothing in the specification or prior art of record to indicate that one of ordinary skill in the art could have ascertain the scope of the recited degree. It is suggested that applicant clarify the meaning of the claims. See Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. §112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162 (Feb. 9, 2011), page 7165.
Claim Rejections - 35 USC § 103
10. 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.
11. Claim(s) 26-29 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bosnes et al. (Invitrogen, 2017; cited on IDS filed on 01/12/2024).
12. Claims 26-29 and 33 are drawn to a method for producing a purified ribonucleic acid (RNA) molecule, the method comprising: a) fixing a first magnetic bead in place by a magnetic field, wherein an in vitro transcription (IVT) template is linked to the first magnetic bead; b) contacting the first magnetic bead of step a) with a reagent mixture suitable for IVT of the template under condition in which IVT occurs, thereby producing an RNA molecule; c) separating the RNA molecule from the first magnetic bead, thereby producing the RNA molecule; d) contacting the purified RNA molecule of step c) with a second magnetic bead under conditions that allows for the purified RNA molecule to remain associated with the second magnetic bead during washing; e) washing of the second magnetic bead while the second magnet bead is fixed in place by a magnetic field; f) releasing the purified RNA molecule from association with the second magnetic bead, thereby producing a highly purified RNA molecule; and g) repeating steps a) to f) at least once, wherein the second magnetic bead of step f) of the (or each) immediately previous cycle is reused as the second magnetic bead in step d) of the following cycle, and optionally wherein the first magnetic bead of step c) of the (or each) immediately previous cycle is reused as the first magnetic bead in step a) of the following cycle.
13. With respect to claim 26, Bosnes et al. each a method for producing a purified ribonucleic acid (RNA) molecule, the method comprising: a) fixing a streptavidin functionalized Dynabead in place by a magnetic field, wherein an in vitro transcription (IVT) template is linked to the first magnetic bead; b) contacting the first magnetic bead of step a) with a reagent mixture suitable for IVT of the template under condition in which IVT occurs, thereby producing an RNA molecule; c) separating the RNA molecule from the first magnetic bead, thereby producing the RNA molecule; d) contacting the purified RNA molecule of step c) with a second magnetic bead under conditions that allows for the purified RNA molecule to remain associated with the second magnetic bead during washing; e) washing of the second magnetic bead while the second magnet bead is fixed in place by a magnetic field; f) releasing the purified RNA molecule from association with the second magnetic bead, thereby producing a highly purified RNA molecule [see Column 1; Figures 1-4].
With respect to claim 28, Bosnes et al. teach the method wherein the first magnetic bead is a streptavidin coated magnetic bead and the second bead is a carboxylic acid coated bead [see column 1 under Materials and Figures 1 and 5].
With respect to claim 29, Bosnes et al. teach the method wherein the magnetic beads are Dynabeads. Although Bosnes et al. does not explicitly teach wherein the beads comprise a saturation mass magnetization of about 30 emu/g to about 90 emu/g, given that Dynabeads are identical to the magnetic beads used in the present disclosure, it is the examiner’s position that absent evidence otherwise, this feature is inherent to the Dynabeads taught by Bosnes et al. Since the Office does not have the facilities for examining and comparing applicants’ beads with the beads of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that the Dynabeads of the prior art does not possess the same material structural and functional characteristics of the claimed magnetic beads). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
With respect to claim 33, Bosnes et al. teach the method wherein the IVT template is a DNA produced by PCR using a biotinylated forward primer [see Figure 1].
Although Bosnes et al. does not explicitly teach the method of claim 26, g) repeating steps a) to f) at least once, wherein the second magnetic bead of step f) of the (or each) immediately previous cycle is reused as the second magnetic bead in step d) of the following cycle, and optionally wherein the first magnetic bead of step c) of the (or each) immediately previous cycle is reused as the first magnetic bead in step a) of the following cycle and 27 wherein step g) comprises repeating steps a) to f) at least 2, 3, 4, 5, or 6 times, Bosnes et al. does teach that IVT can be efficiently performed from a biotinylated template immobilized on Dynabeads Streptavidin beads and immobilized templates can be re-used in sequential reactions, and higher concentrations of mRNA can be obtained by including concentration steps using different beads for generic binding and elution [see column 1]. As such, before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to optimize the method conditions for repeating steps and one of ordinary skill in the art would desire to do so in order to maximize mRNA production and purification for downstream therapeutic applications as taught by Bosnes et al.
14. Claims 30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Bosnes et al. (Invitrogen, 2017; cited on IDS filed on 01/12/2024) as applied to claims 26-29 and 33 above, and further in view of Finne et al. (WO 2006/085104 A1; cited on IDS filed on 01/12/2024) and Bosch (WO 2015/188994 A1; cited on IDS filed on 01/12/2024 with machine translation attached).
15. The relevant teachings of Bosnes et al. as applied to claims 26-29 and 33 are set forth above.
However, Bosnes et al. does not teach the method of claim 30, wherein the conditions of contacting the purified RNA in the presence of a binding solution comprising an oligoethylene glycol and salt, the oligoethylene glycol comprising from about 2 to about 70 ethylene glycol units in linear arrangement, wherein during the contacting the oligoethylene glycol is present at a concentration of at least about 35% v/v and the salt is present at a concentration of between about 1 M and about 2 M and the method of claim 32, wherein step e) washing comprises use of a wash buffer comprising an aqueous C1-C6 alcohol and/or an aqueous C2-C10 polyol.
Finne et al. teach similar methods of purifying nucleic acids such as DNA and RNA using a magnetic bead solid support in the presence of a oligoethylene glycol comprising from about 2 to about 70 ethylene glycol units in linear arrangement at 10-90% and a salt [see Abstract; p. 6-7] in order to obtain high quality and pure nucleic acid preparations [see p. 1].
Bosch also teach similar methods for the enrichment and purification of nucleic acids bound to a solid phase wherein the concentration of the salt depends on the salt used and teach ranges of salts of 1-3M, and teach wash buffers comprising alcohol such as ethanol or isopropanol [see paragraphs 0003; 0014; 0038-0039].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Bosnes et al., Finne et al. and Bosch according to the teachings of Finne et al. and Bosch to include oligoethylene glycol, salts and alcohol in the buffers and wash buffers in the nucleic acid purification methods of Bosnes et al. because Finne et al. teach that oligoethylene glycol in combination with magnetic beads is an effective method to obtain high quality and pure nucleic acid preparations. Bosch teach that high salts and alcohols are commonly used in the purification of nucleic acids. One of ordinary skill in the art would have had a reasonable expectation of success and reasonable level of predictability to combine the teachings of Bosnes et al., Finne et al. and Bosch because Finne et al. acknowledges that oligoethylene glycol in combination with magnetic beads is an effective method to obtain high quality and pure nucleic acid preparations and Bosch teach that high salts and alcohols are commonly used in the purification of nucleic acids. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
16. Status of the claims:
Claims 1-2, 26-30, 32-34, and 36-44 are pending.
Claims 1-2, 34, and 36-44 stand withdrawn pursuant to 37 CFR 1.142(b).
Claims 26-30 and 32-33 are rejected.
No claims are in condition for an allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656