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 .
Summary
Claims 1-3, 13, 30, 42, 47, 49, 60, 70, 72-73, 75, 78, 80, 86-90 and 143 are pending in this office action. Claims 4-12, 14-29, 31-41, 43-46, 48, 50-59, 61-69, 71, 74, 76-77, 79, 81-85, and 91-142 are cancelled. All pending claims are under examination in this application.
Priority
The current application was filed on May 12, 2023 is a 371 of PCT/EP2021/081741 filed November 15, 2021 which in turn claims domestic priority to provisional patent application 63/114,478 filed November 16, 2020. The current application claims foreign priority to PCT/EP2020/082602 filed November 18, 2020.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on January 16, 2026, October 31, 2025, September 3, 2025, December 12, 2024, March 8, 2024, and January 19, 2024 are acknowledged. A signed copy of the six documents are attached to this office action.
Claim Objections
Claims 91-142 are objected to because of the following informality: In the amended claim set, please add a parenthesis to close the text “canceled.”
Appropriate correction is required.
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 42 and 90 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.
Claims 42 and 90 recite the substituents in table form. Claims may contain tables either if necessary to conform to 35 U.S.C. 112 or if otherwise found to be desirable. See MPEP 2173.05(s). When such a patent is printed, however, the table will not be included as part of the claim, and instead the claim will contain a reference to the table number. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant' s convenience.” Ex parte Fressola, 27USPQ2d 1608, 1609 (Bd, Pat. App. & Inter. 1993) (citations omitted). In the instant case, please delete the table border.
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 non-obviousness.
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 1-3, 13, 30, 42, 47, 49, 60, 70, 72-73, 75, 78, 80, 86-90 and 143 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (WO2017/218704A1) in view of Ansell et al. (WO2017/075531A1) and Ketterer et al. (US2018/0243219A1).
[The Examiner is going to introduce each reference and then combine them where appropriate to reject the instant claims.]
1. Smith et al.
Smith et al. is considered the closest prior art as it teaches stabilized formulations of lipid nanoparticles (see title). In addition, Smith et al. disclose that the reference features novel lipids and compositions involving the same. Lipid nanoparticles include a novel lipid as well as additional lipids such as phospholipids, structural lipids, and PEG lipids. Lipid nanoparticles further including therapeutics and/or prophylactics such as RNA are useful in the delivery of therapeutics and/or prophylactics to mammalian cells or organs to, for example, regulate polypeptide, protein, or gene expression (see abstract).
2. Ansell et al.
Ansell et al. teach novel lipids and lipid nanoparticle formulations for delivery of nucleic acids (see title). Furthermore, Ansell et al. disclose compounds are provided having the following structure: (I) or a pharmaceutically acceptable salt, tautomer or stereoisomer thereof, wherein R1, R2, R3, L1, L2, G1, G2 and G3 are as defined herein. Use of the compounds as a component of lipid nanoparticle formulations for delivery of a therapeutic agent, compositions comprising the compounds and methods for their use and preparation are also provided (see abstract).
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3. Ketterer et al.
Ketterer et al. teach lyophilization of RNA (see title). Additionally, Ketterer et al. disclose that the present invention is directed to the field of RNA formulation, in particular, to lyophilization of RNA. The invention provides a method for lyophilization of RNA. The present invention further concerns a lyophilized composition obtainable by the inventive method, a pharmaceutical composition, a vaccine and a kit or kit of parts. Moreover, the present invention provides a novel use of a cryoprotectant for lyophilizing RNA, the use of the inventive method in the manufacture of a medicament as well as the first and second medical use of the composition obtainable by the inventive method, the pharmaceutical composition, the vaccine or the kit or kit of parts according to the invention (see abstract).
Combination of Smith et al., Ansell et al., and Ketterer et al.
Regarding instant claim 1, Smith et al., Ansell et al., and Ketterer et al. teach a method for preparing a pharmaceutical composition. The necessary citations of Smith et al., Ansell et al., and Ketterer et al. that pertain to instant claim 1 are presented in Table I.
Table I
Instant Claim 1
Smith et al., Ansell et al., and Ketterer et al. Citations
A method for preparing a pharmaceutical composition comprising the steps:
Smith et al. describes the addition of Tris buffer, NaCl, and Poloxamer-188 to concentrated mRNA-MC3 (mRNA-ionizable lipid component) lipid nanoparticle (LNP) formulations to achieve a final mRNA concentration of 1 mg/ml, 20mM Tris Buffer, 5% w/v sucrose, 140 mM NaCl, and 0.4% w/v P188 (see Example 4 within Smith et al.).
(I) preparing a formulation comprising lipid nanoparticles (LNPs), wherein the LNPs comprise a cationically ionizable lipid and mRNA, wherein the pH of the formulation is at most 6.5, and wherein one or more of the following applies: step (I) does not comprise adding NaCl;
Smith et al. disclose the composition is prepared by dissolving the lipids in ethanol, combining the solution with an RNA solution and filtrating the solution into a buffer solution and lyophilizing it (see Examples 1-4 within Smith et al.).
Despite Smith et al. disclosing the use of NaCl within Example 4, alternative salts can be used (see paragraph [00416] within Smith et al.). Furthermore, Ketterer et al. lists additional salts that can be used other than NaCl (see paragraph [0256] within Ketterer et al.).
Ansell et al. disclose a preparation of lipid nanoparticles encapsulating RNA in citrate buffer (see Example 1 within Ansell et al.). The preparation is dialysed against phosphate buffered saline. Ansell et al. disclose cationic lipids such as the one shown within Figure I:
Figure I
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(see page 31, compound 3 within Ansell et al.). The pH of the nanoparticle prepared is 4 (see Example 1 within Ansell et al.).
and (II) freezing the formulation to about -10°C or below thereby obtaining the pharmaceutical composition in frozen form.
Ketterer et al. disclose a drying protocol (see paragraph [0228] within Ketterer et al.). Ketterer et al. disclose the primary drying temperature of -40 °C to +20 °C (see paragraph [0231] within Ketterer et al.) en route to the final lyophilized product.
Therefore, a skilled artisan (POSITA) would consult the disclosures of Smith et al., Ansell et al., and Ketterer et al. to teach all the elements of instant claim 1.
The remainder of the instant claims which are either directly or indirectly dependent on claim 1 are taught in full by the combination of Smith et al., Ansell et al., and Ketterer et al.
Regarding instant claim 2, Smith et al., Ansell et al., and Ketterer et al. teach further comprising the step (III) freeze-drying the frozen formulation, thereby obtaining the pharmaceutical composition in freeze-dried form. Please see the discussion and citations within instant claim 1 for the necessary rejection text. Ketterer et al. disclose a detailed lyophilization (freeze dry) protocol (see paragraphs [0228-0246] within Ketterer et al.).
Regarding instant claim 3, Smith et al., Ansell et al., and Ketterer et al. teach wherein:
(1) the pH of the formulation is at most 6.0;
(2) the pH of the formulation is lower than the pKa of the cationically ionizable lipid;
(3) the formulation is substantially free of citric anions;
(4) the formulation is substantially free of inorganic phosphate anions;
(5) step (I) does not comprise adding KCl;
(6) the formulation further comprises a poloxamer; or
(7) a combination thereof.
Please see the discussion and citations within instant claim 1. The pH of 4 is lower than the pKa of the cationically ionizable lipid (pKa = ~5 to ~7; see page 48, Example 2 within Ansell et al.). The formulation can be substantially free of citric anions. Smith et al. disclose a large list (>20) of alternative buffering agents besides citrate buffers and inorganic phosphate anions (the buffering agents are dependent upon the targeted pH; see paragraph [00406] within Smith et al.). Smith et al. does not disclose the use of KCl within step I. Smith et al. does disclose the use of a poloxamer (see instant claim 1).
Therefore, a skilled artisan (POSITA) would be able to meet the instant claim 3 limitations under routine experimental conditions.
Regarding instant claim 13, Smith et al., Ansell et al., and Ketterer et al. teach wherein the formulation comprises a buffer system, a cryoprotectant, or a combination thereof. Smith et al. disclose the use of both a buffering system (the buffering agents are dependent upon the targeted pH; see paragraph [00406] within Smith et al.) and a cryoprotectant (see Example 4 within Smith et al.).
Regarding instant claim 30, Smith et al., Ansell et al., and Ketterer et al. teach wherein the buffer system comprises water and a buffering substance, wherein
(i) the buffering substance comprises HEPES, histidine, Tris, or acetic acid;
(ii) the buffering substance comprises a concentration of at most 50 mM, at most 40 mM, or at most 20 mM;
(iii) the cryoprotectant comprises one or more carbohydrates;
(iv) the cryoprotectant comprises sucrose, trehalose, glucose, or a combination thereof;
(v) the cryoprotectant comprises a concentration of at least 1% w/v; or
(vi) a combination thereof.
Smith et al. disclose the buffering system of HEPES and acetic acid (see paragraph [00406] within Smith et al.). Smith et al. disclose the buffering agent is 20 mM Tris Buffer (see Example 4 within Smith et al.). Smith et al. disclose the use of carbohydrates sucrose and trehalose (see claim 27 within Smith et al.) comprising at least 1% w/v (see Example 4 within Smith et al.).
Therefore, a skilled artisan (POSITA) would be able to meet the instant claim 30 limitations under routine experimental conditions.
Regarding instant claim 42, Smith et al., Ansell et al., and Ketterer et al. teach the desired cationic ionizable lipid. Ansell et al. does not disclose the specific structure (see Table I within Ansell et al.) within instant claim 42 (iii). However, the Ansell et al. disclosure supports structures B-E as described within Figure II.
Figure II
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Therefore, a skilled artisan (POSITA) would be able to meet the instant claim 30 limitations under routine experimental conditions.
Also, Smith et al. disclose use of cationic and/or ionizable lipid DODMA (see claim 69 within Smith et al.).
Regarding instant claims 47 and 49, Smith et al., Ansell et al., and Ketterer et al. teach wherein the LNPs further comprise one or more additional lipids, selected from the group consisting of polymer conjugated lipids, neutral lipids, steroids, and combinations thereof, or the LNPs comprise the cationically ionizable lipid, a polymer conjugated lipid, a neutral lipid, and a steroid. Smith et al. disclose additional lipids consisting of polymer conjugated lipids (see claim 64 within Smith et al.), neutral lipids (see claims 58-59 within Smith et al.), and/or steroids (see claim 62 within Smith et al.), and combinations thereof. Furthermore, Smith et al. disclose the use of the phospholipids, DSPC and DPPC, and combinations thereof (see claim 60 within Smith et al.).
Regarding instant claim 60, Smith et al., Ansell et al., and Ketterer et al. teach wherein
(i) the ratio of the cationically ionizable lipid to mRNA is between 2:1 and 12:1;
(ii) the mRNA is encapsulated within or associated with the LNPs;
(iii) the mRNA comprises a modified nucleoside in place of uridine;
(iv) the mRNA comprises a modified nucleoside in place of uridine, wherein the modified nucleoside is selected from pseudouridine (w), N1-methyl-pseudouridine (mlw), and 5- methyl-uridine (m5U);
(v) the mRNA comprises a 5' cap, a 5' UTR, a 3' UTR, apoly-A sequence, or a combination thereof;
(vi) the mRNA encodes one or more polypeptides; or
(vii) a combination thereof.
Smith et al. disclose the ratio of the cationically ionizable lipid to mRNA is between 2:1 and 12:1 (overlapping region; 2.5:1 to 25:1; Table 1 depicts the ionizable lipid to be ~50 mol % of the lipids and paragraph [00521] disclose the ratio of the lipid component to the therapeutic to be between 5:1 to 25:1; both within Smith et al.). The mRNA is encapsulated within the LNPs (see paragraphs [00206] and [00228] within Smith et al.). The mRNA comprises a modified nucleoside in place of uridine (see paragraph [00258] for limitations iii through v within Smith et al.). The mRNA encodes one or more polypeptides (see paragraph [00255] within Smith et al.).
Therefore, a skilled artisan (POSITA) would be able to meet the instant claim 60 limitations under routine experimental conditions and combine these limitations where appropriate.
Regarding instant claim 70, Smith et al., Ansell et al., and Ketterer et al. teach wherein the one or more polypeptides comprise an epitope for inducing an immune response against an antigen in a subject; and/or the mRNA encodes an amino acid sequence comprising a SARS-CoV-2 S protein, an immunogenic variant thereof, or an immunogenic fragment of the SARS-CoV-2 S protein or the immunogenic variant thereof. Smith et al. disclose the one or more polypeptides comprise an epitope for inducing an immune response against an antigen in a subject (see paragraphs [00498-00499] and [00252] within Smith et al.).
Regarding instant claims 72 and 73, Smith et al., Ansell et al., and Ketterer et al. teach wherein the formulation is frozen to a temperature ranging from about -30°C to about -10°C, such as to a temperature ranging from about -25 °C to about -15 °C to a temperature ranging from about -25°C to about -20°C, or to a temperature of about -20°C. Ketterer et al. disclose a detailed lyophilization protocol within the temperature range of instant claim 72 (see paragraphs [0228-0243] within Ketterer et al.). Additionally, Ketterer et al. disclose the moisture content after lyophilization can be as low as 0.1% (see paragraph [0244] within Ketterer et al.).
Regarding instant claim 75, Smith et al., Ansell et al., and Ketterer et al. teach wherein step (I) comprises:
(a) preparing an mRNA solution containing water and a buffering system;
(b) preparing an ethanolic solution comprising the cationically ionizable lipid and, if present, one or more additional lipids; and
(c) mixing the mRNA solution prepared under (a) with the ethanolic solution prepared under (b), thereby preparing the formulation comprising LNPs; or
(a') preparing liposomes or a colloidal preparation of the cationically ionizable lipid and, if present, one or more additional lipids in an aqueous phase; and
(b') preparing an mRNA solution containing water and a buffering system; and (c') mixing the liposomes or colloidal preparation prepared under (a') with the mRNA solution prepared under (b').
Smith et al. disclose the composition is prepared by dissolving the lipids in ethanol, combining the solution with an RNA solution and filtrating the solution into a buffer solution and lyophilizing it (see Examples 1-4 within Smith et al.). A skilled artisan (POSITA) could modify this procedure under routine experimental conditions to obtain the desired preparation.
Regarding instant claim 78, Smith et al., Ansell et al., and Ketterer et al. teach a method of storing a pharmaceutical composition, comprising preparing a pharmaceutical composition according to the method of instant claim 1 and storing the pharmaceutical composition at a temperature ranging from about -30°C to about -10°C, at a temperature ranging from about -25°C to about - 15°C, at a temperature ranging from about -25°C to about -20°C, or at a temperature of about -20°C. Smith et al. disclose a storing the resulting LNPs at the instant claim 78 limitations (overlapping region; see paragraph [00428] within Smith et al.).
Regarding instant claim 80, Smith et al., Ansell et al., and Ketterer et al. teach a frozen pharmaceutical composition prepared by the method of instant claim 1. Please see the discussion and citations within instant claims 1 and 75 for the necessary rejection text.
Regarding instant claim 86, Smith et al., Ansell et al., and Ketterer et al. teach the method of instant claim 1, further comprising thawing the frozen pharmaceutical composition thereby obtaining a ready-to-use pharmaceutical composition. Please see the discussion and citations within instant claim 1 for the necessary rejection text.
Smith et al. disclose the thawing of the LNPs prior to use within a subject (see paragraph [00553] within Smith et al.).
A skilled artisan (POSITA) would thaw the composition for the appropriate amount of time prior to administration.
Regarding instant claim 87, Smith et al., Ansell et al., and Ketterer et al. teach the method of instant claim 1, further comprising reconstituting the freeze-dried pharmaceutical composition thereby obtaining a ready-to-use pharmaceutical composition. Please see the discussion and citations within instant claim 1 for the necessary rejection text. Smith et al. disclose storing and reconstituting the LNPs prior to administration within a subject (see paragraph [0037] within Smith et al.).
Regarding instant claim 88, Smith et al., Ansell et al., and Ketterer et al. teach a ready-to-use pharmaceutical composition prepared by the method of claim 86. Please see the discussion and citations within instant claim 86 and 87 for the necessary rejection text.
Regarding instant claim 89, Smith et al., Ansell et al., and Ketterer et al. teach a pharmaceutical composition comprising lipid nanoparticles (LNPs), wherein the LNPs comprise a cationically ionizable lipid and mRNA, wherein:
(i) the pharmaceutical composition comprises NaCl and KCl at a combined amount of less than 10% by weight, based on the total amount of lipids and mRNA in the pharmaceutical composition; and
(ii) the pH of the pharmaceutical composition, when in an aqueous liquid form, is at most 6.5; and,
wherein the pharmaceutical composition is in a frozen form or in a freeze-dried form.
Please see the discussion and citations within instant claim 1 for the necessary rejection text. Ketterer et al. disclose the use of both NaCl and KCl at a level of 50 mM and 3 mM, respectively (see paragraph [0256] within Ketterer et al.). This combined 53 mM value would consume less than 10% of the mass. The pH of the nanoparticle prepared within the Ansell et al. disclosure is 4 (see Example 1 within Ansell et al.). Ketterer et al. disclose a detailed lyophilization protocol within the temperature range of instant claim 72 (see paragraphs [0228-0243] within Ketterer et al.).
Regarding instant claim 90, Smith et al., Ansell et al., and Ketterer et al. teach preparation of the desired LNP pharmaceutical composition. Please see the discussion and citations within instant claims 1-3, 13, 30, 42, 47, 49, 60, 70, 72, and 89 for the necessary rejection text. Additionally, Ketterer et al. disclose the use of both NaCl and KCl at a level of 50 mM and 3 mM, respectively (see paragraph [0256] within Ketterer et al.). This combined 53 mM value would consume less than 5% of the mass. Furthermore, Smith et al. disclose a buffering agent concentration of 20mM Tris Buffer and a cryoprotectant value for sucrose of 5% or 8% w/v (see Example 4 within Smith et al.).
Regarding instant claim 143, Smith et al., Ansell et al., and Ketterer et al. teach a method for inducing an immune response in a subject, comprising administering the pharmaceutical composition of instant claim 80 to the subject. Please see the discussion and citations within instant claims 80 and 86-87 for the necessary rejection text.
Analogous Art
The Smith et al., Ansell et al., and Ketterer et al. references are directed to the same field of endeavor as the instant claims, that is, a method for preparing a pharmaceutical composition as disclosed within instant claim 1.
Obviousness Analysis
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method for preparing the mRNA-MC3 lipid nanoparticle disclosed by Smith et al., using the teachings of Ansell et al. to introduce the appropriate cationic lipid and further in light of the freezing and lyophilization features described in Ketterer et al., in order to arrive at the subject matter of the instant claims.
The Smith et al., Ansell et al., and Ketterer et al. references all have considerable overlap with mRNA lipid nanoparticles containing a cationic lipid. In this instance, both Smith et al. and Ansell et al. supply the method for preparing the mRNA lipid nanoparticles containing a cationic lipid, while Ketterer et al. supplies the lyophilization protocol. All references are directed to mRNA lipid nanoparticles containing a cationic lipid and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the three references when seeking to improve or adapt a method for preparing mRNA lipid nanoparticles containing a cationic lipid.
Starting with Smith et al., the skilled person only had to try the necessary claim limitations disclosed by Ansell et al. and Ketterer et al. The combination of Smith et al., Ansell et al., and Ketterer et al. would allow one to arrive at the present application without employing inventive skill. This combination of the method for preparing mRNA lipid nanoparticles containing a cationic lipid taught by Smith et al. along with the use of the necessary claim limitations taught by Ansell et al. and Ketterer et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the method for preparing mRNA lipid nanoparticles containing a cationic lipid disclosed by Smith et al. with the use of the necessary claim limitations taught by Ansell et al. and Ketterer et al. Incorporating the disclosure of Smith et al. into the mRNA lipid nanoparticles containing a cationic lipid presented by Ansell et al. and Ketterer et al. represents a predictable use of prior art elements according to their established functions, consistent with MPEP §2143 and KSR.
Furthermore, the additional claim limitations taught by Ansell et al. and Ketterer et al. would have been viewed by a POSITA as routine design optimizations or known modifications of preparing mRNA lipid nanoparticles containing a cationic lipid. Implementing these features in Smith et al.’s mRNA lipid nanoparticles containing a cationic lipid would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of Smith et al., supplemented by Ansell et al. and Ketterer et al. provides all the elements of the claimed invention. The resulting method for preparing mRNA lipid nanoparticles containing a cationic lipid constitutes no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Conclusion
No claims are allowed.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615