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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) and 1.84 for failure to identify the sequence in Figure 1B with a Seq ID number (MPEP 2422.02). Furthermore, an objection to the specification under 37 CFR 1.74 is made for failure to identify this drawing view in the Brief Descriptions of the Drawings. Corrected drawing sheets in compliance with MPEP 608.02 and 37 CFR 1.121(d) containing the appropriate Seq ID may be submitted to correct this deficiency. Alternatively, the deficiency may be corrected by amending the brief description of the drawings in accordance with MPEP 608.01(f) and 37 CFR 1.74 to identify the drawing containing the sequence with a Seq ID NO.
Nucleotide and/or Amino Acid Sequence Disclosures
The disclosure is objected to under 37 CFR 1.831(c) which require that each disclosed nucleic acid and/or amino acid sequence in the application appear separately in the "Sequence Listing", with each sequence further being assigned a sequence identifier, referred to as "SEQ ID NO." or the like (MPEP 2422.01). In paragraph 0037 of the disclosure there are two sequences that appear without Seq IDs, namely the ATrich tract, and the random-sequence DNA fragment ATCGavg.
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 2 and 3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the following informalities: Mixing statutory classes (MPEP 2173.05). The use of the word “method” in claim 2 appears to invoke a method-based claim, however, you have a product by process structure. Claim 3 is a dependent claim further limiting the product of claim 2, however, the use of “comprising replacing” indicates a method-based claim. Claim 2 could be rephrased as “A recombinant plasmid for manufacturing bio-based materials, comprising: a promoter system and a rbs'- synthetic gene cluster, wherein the plasmid is the product of the process comprising…” Claim 3 could be rephrased as, “the recombinant plasmid of claim 2 wherein the RBS-GFPuv of plasmid pTOL03F is replaced with RBS-synthetic gene cluster”.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 8-9 are rejected under 35 U.S.C. 102a1 as being anticipated by Napathorn et al. (Invitrogen 2009).
Napathorn SC, et al 2021 discloses, “PCR using the respective primers for the amplification of phaCAB and phaC genes from the genomic DNA of C. necator strain A-04 was carried out to obtain the ligated DNA fragments using Ex TaqTM DNA Polymerase (TaKaRa Bio Inc., Otsu, Japan) for ligation. The fragment was ligated to pBAD/Thio-TOPO R (Invitrogen, Carlsbad, CA, United States) according to the manufacturer’s protocol.” (“Materials and methods”, paragraph “Construction of the Plasmids and Cloning of the phaCAB and phaC Genes”). This disclosure outlines the creation of a recombinant plasmid comprising a promoter system with a pribnow box, a transcriptional activator (aka pBAD promoter), and downstream of the promoter is a Ribosome Binding Site (RBS) and a synthetic gene. The synthetic gene is the phaCAB gene that encodes PHB synthase. See pBAD/TOPO ThioFusion Expression Kit for sequence verifications. Note that the pribnow sequence is denoted as the sequence labeled -10. Note the explanation of the pBAD promoter on page 31 (which details a transcriptional activator), and the instructions to remove the HP-Thioredoxin synthetic gene by using NcoI and PmeI digestion (page 5 for sequences, page 30 for instructions). Note that these cloning instructions leave the upstream RBS intact. This anticipates claim 1 to a recombinant plasmid with a promoter containing a transcriptional activator and a pribnow box linked to a downstream RBS-synthetic gene sequence. It also anticipates claim 8 which specifies the manufacturing of bio-based materials function for the plasmid of claim 1 to include polyhydroxybutyrate (PHB).
The functional roles of the various DNA sequences in the pBAD/TOPO plasmid are outlined in the expression kit manual (Invitrogen 2009) on page 29. Specifically, the -10 region (pribnow sequence) serves as a binding site for RNA polymerase for transcription from pBAD, the optimized ribosome binding site serves to increase efficiency of recombinant fusion protein expression by facilitating ribosome binding, and the functional explanation of the pBAD promoter on page 31 anticipate claim 9. This disclosure indicates that overall activity of the promoter system (as judged by recombinant protein expression) is controlled by the AraC transcriptional activator, the pribnow sequence, and the RNA polymerase.
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Napathorn et al. (Invitrogen 2009) in view of McCall, R et al. (2019).
Napathorn et al. (Invitrogen 2009) discloses the use of a recombinant plasmid using a transcriptional activator to control transgene expression. It does not disclose the use of the specific transcriptional activator, AtxA.
McCall, R et al. (2019) elucidates the function of the AtxA transactivator. Specifically, “Here, we provide evidence that AtxA binds to the promoter region of the pagA gene encoding the main central protective antigen (PA) component of the anthrax toxin. These data suggest that AtxA binding plays a direct role in gene regulation.” (“Importance” paragraph).
Thus, the creation of a plasmid where AtxA is the transcriptional activator is merely the substitution of one known element for another to achieve predictable results. It is well known that AtxA is a transcriptional activator used to initiate gene expression, and these types of regulatory elements have been used for decades in recombinant plasmids to control transgene expression. Thus, the art teaches the interchangeability of transcriptional activators and the selection of a particular trans activator is a routine design choice. Therefore, claim 6 is rendered obvious.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over McCall, R et al. (2019) as applied to claim 6 above, and further in view of Patent Number US6537779B1. Claim 6 is rendered obvious as rationalized above. In addition, US6537779B1
discloses the use of the PT7 promoter and T7 terminator sequences in recombinant protein expression. Specifically, they detail, “The T7 terminator sequence from T7 gene 10 was cloned as annealed synthetic oligomers #5 and #6…” (Specific description paragraph 13). Additionally, “The T7 promoter and lac operator sequence was cloned as annealed synthetic oligonucleotides #11 and #12…” (Specific description paragraph 19). Thus, the addition of the PT7 promoter and the T7 terminator is routine in the field, and addition of those elements to the AtxA transactivator would amount to the combination of known elements to achieve predictable outcomes. Thus, claim 7 is obvious.
Allowable Subject Matter
Claims 2-5 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and if the 112(b) rejection above is overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam M Smith whose telephone number is (571)272-7517. The examiner can normally be reached Monday- Friday 10:30AM-5PM.
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/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638