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 .
DETAILED ACTION
Responsive to claim set of 2/27/2025
Claims pending 1-9,12-13,22,23,25,27,30,40,50,56
Claims currently under consideration 1-9,12-13,22,23,25,27,30,40,50,56
Priority
This application published as 20250075201 has a filing date of 01/18/2024 and is a 371 of:
PCT/US2022/074975 (WO2023023487) 08/15/2022
PCT/US2022/074975 has PRO 63/233,658 08/16/2021
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 4 is rejected under 35 U.S.C. 102(a)(1 & 2) as being anticipated by Dias et al (US PG-Pub 20180256741).
Throughout the document and especially the title and abstract, Dias et al is drawn to codon-optimized Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) mRNAs. More particularly appearing to read on present claim 4, in example 1 with data shown in figure 1 plus paragraphs 0062-0066, 0109 and/or 0004: Dias et al: provides a plurality of nucleotide sequences encoding a protein generated by a sequence optimization algorithm; for each the nucleotide sequences, Dias et al provides an insert comprising the nucleotide sequences and a set of homologous ends; provides a vector backbone comprising the set of homologous ends; for each nucleotide sequence, assembling the insert and the vector backbone via the set of homologous ends, wherein the assembly yields a plasmid comprising the nucleotide sequence flanked by a 5' untranslated region (5' UTR) and a 3' untranslated region (3' UTR) and operationally linked to an RNA polymerase promoter, wherein the 5' UTR, the 3' UTR and the RNA polymerase promoter are either part of the insert or the vector backbone; adds each plasmid to an in vitro transcription reaction mixture to transcribe the nucleotide sequence into an mRNA transcript; and finally selects nucleotide sequences that generate a full-length mRNA transcript. See also paragraphs 0045-0096
Claim Rejections - 35 USC § 103
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.
Claim 56 is rejected under 35 U.S.C. 103 as being unpatentable over Guo (US PG-Pub 20110124851).
Appearing like claim 56, in accordance with the title and abstract, Guo is drawn to isolation of nucleic acids. More particularly in document claims 1-5,12,14,16,17 taken with paragraphs 0050 and 0048 , Guo discloses: A. providing an impure preparation comprising a DNA construct in a receptacle; B. adding (i) a chaotropic salt, (ii) an alcohol and/or an amphiphilic polymer (under conditions that result in the formation of a precipitate comprising the DNA construct); C. adding a DNA-binding magnetic particle to bind the precipitate formed in step (B) to the magnetic particle; D. transferring the magnetic particle with the bound precipitate from the first receptacle to a first wash solution; E. transferring the magnetic particle with the bound precipitate to a second wash solution; F. transferring the magnetic particle with the bound precipitate from a wash solution to an elution medium; and G. solubilizing the precipitate in the elution medium to release the purified DNA construct.
While Guo does not expressly teach a second, third and fourth receptacle of claim 56 as a single embodiment, Guo does describe processing blood with 96-well plates in paragraph 0016.
And as such, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have processed DNA samples with Guo’s reagents in a 96-well format including wells for magnetic bead washing and elution; In so far as the Guo procedure differs in sequence of adding ingredients, as interpreted in MPEP 2144.04 IV C, the courts have held selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results
One of ordinary skill in the art would have been motivated to have processed DNA samples with Guo’s reagents in a 96-well format including wells for magnetic bead washing and elution for the benefit of higher throughput, as further mentioned by Guo in paragraph 0016.
Indeed one of ordinary skill in the art would have had a reasonable expectation of success in applying a 96 well plate filled with Guo’s reagents toward processing DNA samples since such plates are art-recognized as robust, having been used molecular biology for decades.
Claim Rejections - 35 USC § 112
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 1-9,12-13,22,23,25,27,30,40,50,56 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 pre-AIA the applicant regards as the invention.
Claims 1,2,3 & 4 recites the limitation "the nucleotide sequence" (singular) in step (b) of claims 1,2,3 & 4, however step (a) of claims 1,2,3 & 4 is drawn to a plurality of sequences. Claim 7(vii) recites the limitation” the codon adaptation index in lines 1 and 2. There is insufficient antecedent basis for these limitations in the claims, rendering the metes and bounds uncertain.
Regarding claims 5,8,13,30 & 50, the phrases “e.g.”, “in particular 0.8”, “e.g.” (twice), “e.g.” (twice), “e.g.” respectively render each claim indefinite because it is unclear whether the limitations following the phrase/term constitute the metes and bounds of the claim or not are part of the claimed invention. See MPEP § 2173.05(d).
Claim 56 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps which render the metes and bounds unascertainable are as follows.
Claim 56 recites the limitation "the precipitate formed in step (b)" in step (c), however, such precipitate is indicated as optional therein step (b).
In accordance with MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
In so far as the metes and bounds of the offending claim(s) may not be interpreted properly for the reasons above, all dependent claims therefrom claim 1 are rejected as being indefinite as well.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M GROSS/Primary Examiner, Art Unit 1684
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