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/Restriction
Claims 1-5, 7, 11-19, 23-28 are pending.
Applicant's election with traverse of a vector (Group I, claims 1-3, 7, and 11-13, as identified in the Office Action on 06/30/2026) in the reply filed on 07/10/2026 is acknowledged. The traversal is on the ground(s) that the compositions pertaining to cells and kits (previously Group II) are now amended to depend on the base claim (the vector of claim 1).
Applicant’s arguments in regards to the cells/kits are found persuasive and therefore, the election requirement for this group has been withdrawn.
For the species, Applicant elects, 5' - Type1 (linker)--Type2 (Bmp1p, macBp, or CP25p)--Type3 (gfp, mRuby, or nanoluc)--Type4 (T7-terminator)-Type5 (linker)--Type6-7--Type8 (Tn7/Tn10/RSF1010)-3' as a species of modular elements; a marine bacterium as a species of cell; Nereida for the genus or family of marine bacterium; and SEQ ID NO: 3 for the species of Type-1 linker.
In regards to types of bacteria, in view of the art, upon consideration, the restriction requirement has been withdrawn.
Additionally, while Applicant traverses the restriction requirement generally, Applicant does not point to a specific flaw in the species requirement. Therefore, the species requirement in regards to the species of modular assembly and sequence is deemed proper and is therefore made FINAL.
Claims 24-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/10/2026.
Claims 1-5, 7, 11-19, 23, and 28 have been examined on their merits.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see references 15, 70, and 109). 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.
Additionally, the specification references color in the drawings (“highlighted in red”, paragraph [0196]), but no submission for color drawings has been submitted and approved. Applicant should remove reference to color in the drawings or submit a petition to accept color drawings.
Claim Objections
Claim 12 is objected to for the following informalities: the claim recites abbreviated terms followed by the spelled-out term in parentheses (e.g., “LPS (lipopolysaccharide)”, etc.). However, terms should be spelled out in their first instance, with the abbreviated term being in parentheses (e.g., “lipopolysaccharide (LPS)”, etc. would be ameliorative). Appropriate correction is required.
Claim 13 similarly puts abbreviated terms before spelled out term “GST (gluathionine S Transferase)”. Furthermore, it is noted that “His” is the abbreviated term for histidine, whole “polyHis” is the abbreviated term for polyhistidine. Moreover, “SUMO” stands “small ubiquitin-like modifier”, and abbreviated terms should be spelled out in their first instance.
Applicant is advised that should claim 2 be found allowable, claim 23 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim 2-3, 13, and 23 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.
In regards to claim 2, the claim requires “(a) 5' - Type1 (linker)--Type2 (Bmp1p, macBp, or CP25p)--Type3 (gfp, mRuby, or nanoluc)--Type4 (T7-terminator)-Type5 (linker)--Type6-7--Type8 (Tn7/Tn10/RSF1010)-3'.” The claim is indefinite because it unclear if the parenthetical information is a requirement or merely exemplary (see MPEP 2173.05(d)).
For example, it is unclear if “Type2” requires one of “Bmp1p, macBp, or CP25p” or if these are merely suggestions. As another example, it is also unclear if “Tn7/Tn10/RSF1010” requires at least one, all of, or any of these elements. This is compounded by the fact that the claim also recites “Type6-7” without clarification.
Additionally, claim 1 already requires a “broad host range CP25” promoter (i.e., CP25p) and therefore, it is unclear what “Bmp1p, macBp, or CP25p” refers to.
For compact prosecution, the claims have been interpreted as optional.
Claim 3 similarly recites “Type-1 a Type-1 linker vector (SEQ ID NO: 3)”, and it is likewise unclear if the parenthetical sequences are required or are examples. For compart prosecution, the parenthetical sequences have been interpreted as optional.
Claim 13 contains the trademark/trade name “FLAG” (as in a “FLAG-tag”). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a DYKDDDDK-tag and, accordingly, the identification/description is indefinite.
Claim 23 likewise recites parenthetical information (e.g., “Type2 (Bmp1p, macBp, or CP25p)”) which is indefinite and interpreted as optional discussed above.
Appropriate clarification is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 23 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites “(a) 5' - Type1 (linker)--Type2 (Bmp1p, macBp, or CP25p)--Type3 (gfp, mRuby, or nanoluc)--Type4 (T7-terminator)-Type5 (linker)--Type6-7--Type8 (Tn7/Tn10/RSF1010)-3'.”
However, claim 1 already requires a “broad host range CP25” promoter (i.e., CP25p) and therefore, fails to limit this claim by allowing for different promoters (e.g., Bmp1p or macBp). Similarly, claim 1 requires a RSF1010 backbone, but this is not further limited by allowing for Tn7 or Tn10 backbones.
Claim 23 similarly, does not further the limitations established in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(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.
Claims 1-5, 7, 11-12, 14, 16-17, 23, and 28 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Moran et al. (US20190015528A1).
In regards to claim 1, the claim is a vector comprising a plurality of modular elements operatively linked to each other. The plurality of modular elements comprise (a) a Type-2 broad range CP25 promoter, (b) a CDS, (c) a Type-4 terminator, (d) a Type 1 and Type 5 connector, and (e) a Type-8 RSF1010 backbone. As discussed above, the “Types” are terms of art that refer to transcriptional units in a modular assembly toolkit. Thus, a “Type-2” is a promoter, a “Type 1” or a “Type 5” is a connector, a “Type-4” is a terminator, and a “Type-8” is a backbone, respectively in a modular assembly toolkit. While not specified by the claim, it is noted that in a modular assembly toolkit, a CDS or structural gene is referred to as “Type-3.” The claim only requires that the promoter (Type-2) comprise “broad range CP25 promoter” and the backbone (Type-8) comprise RSF1010. Otherwise, the claim requires but does not specify a CDS or structural gene, a terminator, and connectors. It is further noted that the claim does not specify an order to the vector and therefore, the limitation “(d) a Type-1 and a Type-5 connector” has broadly been interpreted as requiring a Type-1 connector and a Type-5 connector but does not necessarily require Type-1 connector followed by a Type-5 connector.
Turning to the art, Moran discloses a plasmid (a vector) comprising (a) a Type-2 broad host range CP25 promoter, (b), a CDS (Type-3 element), (c) a type-4 terminator, (d) Type 1 and Type 5 connectors, and (e) a Type 8 RSF1010 backbone (claims 1, 10, 11; paragraph [0126]; Fig. 9).
In regards to claims 2 and 23, the claim requires that the vector comprises a “modular assembly.” This modular assembly comprises the modular elements identified in claim 1 (e.g., Type-2 CP25 promoter, etc.) as in claim 1. While claim 1 only identifies these elements, but does not require ordering, the assembly in claim 2 requires a specific assembly.
In this regard, Moran discloses an assembly of modular elements comprising a Type 1 connector (which is the same as a linker), a Type 2 promoter, a Type 3 CDS, a Type 4 terminator, a connector (linker), Types 6-7 elements, and a Type 8 backbone (Fig. 9A).
In regards to claim 3, as above, Moran discloses a Type-1 connector (linker) (Fig. 9A).
In regards to claim 4, Moran discloses a cell comprising the vector (claims 1, 10, 11)
In regards to claim 5, Moran discloses that this is a bacterial cell (claims 1, 10, 11)
In regards to claim 7, Moran discloses that the vector can be part of a kit (paragraph [0084]).
In regards to claim 11, Moran discloses embodiments comprising a second operatively linked structural gene or CDS (e.g., GFP-AmpR; Fig 9).
In regards to claim 12, Moran discloses that the CDS can be at least Cas9 (Fig 9A).
In regards to claim 14, Moran discloses that the bacteria can be Serratia marcescens (paragraph [0008]). As evidenced by Patterson (PNAS 2002), Serratia marcescens is known to inhabit marine ecosystems (Abstract, p8725; Results and Discussion, p8727), and therefore, is considered a “marine bacterium.”
In regards to claim 16, as above, Moran discloses that the vector can be part of a kit (paragraph [0084]) and discloses a cell comprising the vector (claims 1, 10, 11).
In regards to claim 17, as above, Moran discloses that the bacteria can be Serratia marcescens (paragraph [0008]). As evidenced by Patterson (PNAS 2002), Serratia marcescens is known to inhabit marine ecosystems (Abstract, p8725; Results and Discussion, p8727), and therefore, is considered a “marine bacterium.”
In regards to claim 28, Moran discloses that the CDS can be a Type 3 GFP (Fig 9A).
Therefore, Moran anticipates the invention as claimed.
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 13 is rejected under 35 U.S.C. 103 as being unpatentable over Moran et al. (US20190015528A1) in view of Eichmann et al. (Frontiers in Bioengineering and Biotechnology, 2019).
Moran anticipates claim 1 as above.
In regards to claim 13, Moran teaches that the CDS can be a tag such as GFP (Fig. 9), but does not teach the specific tags as in claim 13. However, it would have been prima facie obvious to use SUMO as a tag because Eichmann teaches that SUMO is a known tag for improving solubility of recombinant proteins (Introduction, p2; Production Model Peptides and Proteins, p8-9) in modular clonal assemblies (Fig. 1, p5).
Therefore, the combined teachings of Moran and Eichmann render the invention unpatentable as claimed.
Claims 15 and 18-19 is rejected under 35 U.S.C. 103 as being unpatentable over Moran et al. (US20190015528A1) in view of Tschirhart et al. (ACS Synthetic Biology, 2019).
Moran anticipates claims 1, 14, and 17 as above.
In regards to claim 15, while as above, Moran teaches that the bacteria can be a marine bacterium, Moran does not teach that the bacteria may be one of the genus or family including Roseobacter.
However, it would have been prima facie obvious to use Vibrio genus bacteria because as taught by Tschirhart, it is known in the art that Vibrio genus marine bacteria can be used as a synthetic chassis in a host of molecular biology and biotechnology applications for the expression of modular elements (Abstract, p2069) and demonstrates its applicability in these cells (Fig. 4, p2074).
Therefore, the combined teachings of Moran and Tschirhart render the invention unpatentable as claimed.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Leonard et al. (ACS Synthetic Biology, 2018).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH (PAUL) MIANO whose telephone number is (571)272-0341. The examiner can normally be reached Mon-Fri from 8:30am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
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