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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-11, drawn to recombinant C1-fixing bacteria, classified in C12N 1/20.
II. Claim12-20, drawn to methods of converting CO and/or CO2 into 3-hydroxypropionate (3-HP) and culturing bacteria, classified in C12P 7/42.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the bacteria could be grown on a rich media that uses carbon/energy sources other than CO and CO2, or it could be used as a parental strain for further genetic modification to produce a bacteria that makes other products.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: (A) separate classification thereof; (B) a separate status in the art when they are classifiable together; (C) a different field of search or (D) a serious examination burden separate from a serious search burden. See MPEP 808.02. In the instant case, the inventions are classified separately.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Telephone Restriction
During a telephone conversation with Maryann Maas on 17 Oct 2025 a provisional election was made without traverse to prosecute the invention of Invention 2, claims 12-20. Specifically, the inventions were presented in a call on 16 Oct 2025, the election was made by voicemail on 17 Oct 2025, and the examiner confirmed receiving the election in a voicemail on 20 Oct 2025. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-11 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Notice to Joint Inventors
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Notice of Potential Rejoinder
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The applicant’s priority claim to provisional application 63/147,108 is acknowledged. The effective filing date used for searching the art for claims 12-20 is 8 Feb 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 18 Oct 2023, 14 Feb 2024, 27 Jun 2024, and 2 Dec 2024 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies of these statements are attached with this action.
Claim Objections
Claims 12-14 are objected to because of the following informalities: the claims are objected to because they depend from a withdrawn claim. Claims under examination should be interpret-able on their own. Appropriate correction is required.
Applicant is advised that should claim 13 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. This also applies to dependent claims 15-16, 17-18, and 19-20. 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). The specification teaches that CO and/or CO2 is used as both a carbon and energy source via the same reaction [0127], so it appears that there are no culture conditions in which CO and/or CO2 is used as a carbon but not energy source, or vice versa. If the statement about the scope of the claims 13-14 is incorrect, this warning can be overcome by evidence proving that there is a difference in scopes between the two claimed methods. Alternately, as a suggestion, applicant may wish to amend to combine claims 13 and 14 by claiming a “gaseous carbon and/or energy source”, though applicant may also argue or amend as they wish.
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 12 and 19-20 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.
Regarding claim 12, the claim defines “a method” but then reads “the process comprising…”. The “process” lacks antecedent basis. In the interest of compact prosecution, the claim limitations will be interpreted as limiting the claimed method/process.
Regarding claims 19-20, both claims read “wherein 3-HP is converted into a material…”, but there is not antecedent basis for 3-HP in the parent claims of 13-14, respectively. Also, if the 3-HP was interpreted as having antecedent basis in the intended use of the bacteria of withdrawn claim 1, the claim is also indefinite because it is unclear whether the claim requires a conversion step to actually occur, or if it only requires that the bacteria is capable of producing 3-HP that is capable of being converted into one of the claimed materials (see MPEP 2111.02 for a discussion of intended uses in preambles). Accordingly, one of ordinary skill in the art would not be able to determine the scope of the claimed method, because they cannot determine which steps are required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to methods of culturing “A recombinant C1-fixing bacteria for producing 3-hydroxypropionate (3-HP) from a carbon source comprising a nucleic acid encoding a group of exogenous enzymes comprising β-alanine pyruvate aminotransferase [(BAPAT)] or γ-aminobutyrate transaminase [(GABT)]; and malonic semialdehyde reductase [(MSR)].” The specification teaches that the 3-HP biosynthesis pathway is found in Figure 1, and the claimed genes are marked with a box in Modified Figure 1 below.
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Modified Figure 1 from the instant specification.
However, the instant Figure 1 does not teach any native pathways for β-alanine to be produced (see Modified Figure 1). A review of the field at the time of filing confirms that there are not native pathways for β-alanine to be produced that are shared across all C1-fixing bacteria. Also, it is self-evident that in order for the bacteria to be capable of “producing 3-hydroxypropionate (3-HP) from a carbon source”, β-alanine must be present for the BAPAT or GABT and MSR enzymes to convert it into 3-HP.
Therefore, one of ordinary skill in the art would recognize that the structure disclosed in the specification as being correlated with the claimed function “producing 3-hydroxypropionate (3-HP) from a carbon source” is the BAPAT or GABT enzyme, the MSR enzyme and one or more pathways for the bacteria to produce β-alanine. The claims require the function but are broader than what is described in the specification because the claims do not require the full structure that is correlated with this function. One of ordinary skill in the art at the time of filing would have recognized that the specification fails to describe the full scope claimed because it does not describe bacteria capable of producing 3-HP but not capable of producing β-alanine. Therefore, claims 12-20 are rejected because the methods require a product that is not adequately supported by the specification. As a suggestion, applicant may wish to amend the claimed microorganism using language from [0069], “a microorganism expresses enzymes from the beta-alanine pathway”, though applicant is welcome to amend or argue as they wish.
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 13-14, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lan et al. (2015; hereafter Lan; PTO-892).
Regarding claims 13-14, Lan teaches Synechococcus elongatus PCC 7942 comprising two alternative pathways for 3-HP production: a malonyl-CoA dependent pathway and a β-alanine dependent pathway (Abstract). The β-alanine dependent pathway comprises SkPYD4, β-alanine aminotransferase, and Msr, malonate semialdehyde reductase, and this pathway assimilates CO2 as an input (Figure 1 and legend). Specifically, the following strains comprise both SkPYD4 and Msr (Table 1 on pg. 165): EL61, EL63, EL64, DC4, EL68, DC1, and DC2. Lan teaches culturing the bacteria in BG-11 medium (pg. 164 section 2.3), which is presumed to be grown aerobically (in media comprising CO2 from the air as a carbon/energy source) because there is no reference to anaerobic growth.
Regarding claims 19-20, Lan teaches that the 3-HP can be converted to acrylic acid, 1,3-propanediol, and others (pg. 163 col. 2 par. 1).
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.
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.
Claims 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Koepke et al. (US-20130323806-A1; hereafter Koepke; PTO-892) in view of Lan et al. (2015; hereafter Lan; PTO-892), Borodina et al. (2015; hereafter Borodina; PTO-892)
Regarding the bacteria of the claims, Koepke teaches bacteria that are genetically engineered to produce 3-hydroxypropionate (3-HP) that produce acetyl-CoA using the Wood-Ljungdahl pathway for fixing CO/CO2 (Abstract). “The “3-HP biosynthesis pathway” is the enzymatic pathway allowing for the conversion of Acetyl-CoA to Malonyl-CoA to Malonate semialdehyde to 3-HP.” [0090]. Figure 1 is also a schematic of the 3-HP production pathway and the enzymes required. The Koepke bacteria fixes CO/CO2 and produces 3-HP from malonate semialdehyde, but does not comprise the exogenous enzymes of claim 1.
Regarding the culturing method of claim 12, Koepke teaches “A process for converting CO and/or CO2 into 3-hydroxypropionate (3-HP), the process comprising: passing a gaseous CO-containing and/or CO2-containing substrate to a bioreactor containing a culture of [genetically engineered bacteria according to their invention] in a culture medium such that the bacteria convert the CO and/or CO2 to 3-HP, and recovering the 3-HP from the bioreactor,” [claim 1, see also 0035-0038, 0048].
Regarding the culturing methods of claims 13-14, Koepke teaches “The genetically engineered bacteria may be cultured by growing in a medium comprising a gaseous carbon source. The carbon source may comprise CO and/or CO2, which may be used as either or both of an energy source or a carbon source” [0057].
Regarding claims 15-16, “The bacteria may optionally be grown under strictly anaerobic conditions.” [0057].
Regarding claims 17-18, “The carbon source may comprise an industrial waste product or off-gas.” [0057].
Regarding claims 19-20, Koepke teaches that “3-HP can be used to derive a number of valuable industrial chemicals including: acrylic acid which is used in the manufacture of paint, paper, adhesives, textiles, speciality coatings, ink, and superabsorbent polymer polyacrylates; 1,3-propanediol which is of use as a solvent, adhesive, cosmetic, or to make polytrimethylene terephthalate used in carpet and textiles; 3-hydroxypropinaldehyde which is used in the preparation of foods, as a feed additive, and as a preservative in the nutritional industry.” [0003].
Koepke does not teach the bacteria comprises a group of exogenous enzymes comprising β-alanine pyruvate aminotransferase or γ-aminobutyrate transaminase; and malonic semialdehyde reductase, as in the bacteria required by claims 12-14 (and their dependent claims).
Regarding the bacteria of the claims, Lan teaches Synechococcus elongatus PCC 7942 comprising two alternative pathways for 3-HP production: a malonyl-CoA dependent pathway and a β-alanine dependent pathway (Abstract). The β-alanine dependent pathway comprises SkPYD4, β-alanine aminotransferase, and Msr, malonate semialdehyde reductase, and this pathway assimilates CO2 as an input (Figure 1 and legend). Specifically, the following strains comprise both of these genes in the β-alanine dependent pathway (Table 1 on pg. 165): EL61, EL63, EL64, DC4, EL68, DC1, and DC2.
Lan also teaches the malonyl-CoA dependent pathway, which uses heterologous enzymes to convert Malonyl-CoA to Malonate semialdehyde (enzyme is Mcr) and then to 3-HP (enzyme is Msr, shared with β-alanine dependent pathway) (Figure 1). Notably, the malonyl-CoA dependent pathway is the same pathway taught by Koepke. Lan teaches that “Biosynthesis of malonyl-CoA is a significantly regulated process in the cell” (pg. 166 col. 2 par. 2), and teaches that adding heterologous genes encoding β-alanine dependent pathway enzymes PanD, SkPYD4, Ppc, and AspC leads to beneficial results in 3 of 4 strains tested and a neutral effect in the 4th strain. Specifically, “expression of the β-alanine dependent pathway in the other strains led to increased 3HP productivity by about 25–40%. There was no obvious change in growth phenotype between the strains with and without expression of synthetic β-alanine pathway” (pg. 167 col. 1 par. 2, Figures 3B-E). Further, Lan teaches that “Both Malonyl-CoA and β-alanine dependent pathways require the same amount of ATP… [but] β-alanine dependent pathway only consumes 1 NADPH, leading to less perturbation in NADH/NADPH ratio.” (pg. 167 col. 2 par. 3).
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to improve the genetically engineered C1-fixing, 3-HP-producing bacteria of Koepke by adding the synthetic β-alanine pathway of Lan, thereby arriving at the claimed invention, because Lan teaches that adding this pathway to 3-HP producing bacteria is likely to improve 3-HP yields (3/4 strains tested) and at worst does not reduce yields (1/4 strains tested). Therefore the combination would be desirable because of the potentially for improved 3-HP yield. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” There would be a reasonable expectation of success at introducing the genetic modifications because Koepke teaches that the C1 bacteria can have heterologous genes introduced by genetic engineering techniques. There would be a reasonable expectation that 3-HP would be produced in the culture method because Koepke teaches that the basal bacteria produces 3-HP; the claim limitation is met whether or not adding the synthetic β-alanine pathway improves yields.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the use of known techniques to improve similar devices, methods or products in the same way is obvious because enhancing a particular class of devices, methods, or products has been made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in other situations. In the instant case, Koepke teach a “base” method for producing 3-HP by culturing C1-fixing bacteria comprising the malonyl-CoA dependent pathway enzymes, and Lan teaches a comparable C1-fixing 3-HP producing bacteria wherein the use of the synthetic β-alanine pathway is taught as advantageous. Thus, one of ordinary skill in the art could have applied the known technique of Lan to the base method/bacteria taught by Koepke to yield predictable results (i.e. the same advantages). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 11-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12-20 of U.S. Patent No. 11,788,092. Although the claims at issue are not identical, they are not patentably distinct from each other. The instant application was filed as a DIV of patent ‘092, but the DIV is not proper because there was no restriction in ‘092. Therefore, there is no protection from a double patenting rejection.
‘092 claim 1 teaches: A recombinant C1-fixing bacteria for producing 3-hydroxypropionate (3-HP) from a carbon source comprising a nucleic acid encoding a group of exogenous enzymes comprising β-alanine pyruvate aminotransferase having SEQ ID NO: 13, 14, or 15 and malonic semialdehyde reductase. This claim anticipates the instant bacteria of claim 1 because the ‘092 bacteria fixes C1 and comprises nucleic acids encoding β-alanine pyruvate aminotransferase and malonic semialdehyde reductase. ‘092 claims 12-20 teach the same steps and limitations as instant claims 12-20.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Nickol can be reached at (571)272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/GARY B NICKOL/Supervisory Patent Examiner, Art Unit 1645