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 .
Status of the Claims
Applicant’s submission filed 15 December 2025 has been entered. However, the amendment to the claims filed on 15 December 2025 does not comply with the requirements of 37 CFR 1.121(c) because the claim listing does not accurately identify the status of the amended claims. Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states (emphasis added):
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of “canceled” or “not entered” may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.”
(3) When claim text in clean version is required. The text of all pending claims not being currently amended shall be presented in the claim listing in clean version, i.e., without any markings in the presentation of text. The presentation of a clean version of any claim having the status of “original,” “withdrawn” or “previously presented” will constitute an assertion that it has not been changed relative to the immediate prior version, except to omit markings that may have been present in the immediate prior version of the claims of the status of “withdrawn” or “previously presented.” Any claim added by amendment must be indicated with the status of “new” and presented in clean version, i.e., without any underlining.
(4) When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of “canceled” or “not entered.”
(ii) Cancellation of a claim shall be affected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as “canceled” will constitute an instruction to cancel the claim.
(5) Reinstatement of previously canceled claim. A claim which was previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number.
As noted above, the amendment under consideration herein fails to comply with 37 CFR 1.121 because the claim listing does not contain an accurate status identifier for claim 110. Instant claim 110 is currently identified as being “Currently Amended”, however there are no amendments marked within the claim and thereby should be identified as “Previously Presented”. Thus, the amendment could be considered non-responsive. However, in the interest of compact prosecution, the amendment at issue will not be considered non-responsive. It is of note that any future responses failing to comply with 37 CFR 1.121 will be held non-responsive, and will not be considered.
Accordingly, upon entry of this amendment, claims 101-106 and 109-116 are pending. Claims 101-102, 104-106, 109, and 111-113 have been amended, while claims 107-108 have been cancelled without prejudice or disclaimer. Therefore, prosecution on the merits continues for claims 101-102, 104-106, 109-114, and 116 as being drawn to the elected invention and species, while claims 103 and 115 are withdrawn for reading on the non-elected species. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Objection to Drawings
The petition filed by Applicant on 15 December 2025 to accept colored photographs and/or drawings is acknowledged and entered into the application file. However, a response from the Office
has not been provided for the petition at the time of writing.
Therefore, the objection is maintained since a granted petition under 37 CFR 1.84(a)(2) has not been provided.
RE: IDS Size Fee and Assertion
The IDS Size Fee and Assertion under 37 CFR 1.17(v)(3) accompanying the IDS filed 15 December 2025 is compliant and renders the previous compliance issues for the IDS filed 16 July 2025 moot.
Therefore, the IDS filed 16 July 2025 will be considered.
RE: Rejection of claims 101-102, 104-110, 114, and 116 under 35 USC 102(a)(1) and 35 USC 102(a)(2) over Han et al as evidenced by National Cancer Institute
The cancellation of claims 107-108 renders the rejection moot for those claims. For the remaining claims, Applicant has amended independent claim 102 to require a purified human CD8 T cell, and independent claim 104 to require the isolation or enrichment of human CD8 T cells. These limitations are newly presented and have not previously been considered, but obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 101-102, 104-106, 111-113, and 116 under 35 USC 102(a)(2) over Yivgi-Ohana et al
Applicant has amended independent claim 102 to require a purified human CD8 T cell, and independent claim 104 to require the isolation or enrichment of human CD8 T cells. These limitations are newly presented and have not previously been considered.
With that, Applicant has traversed the rejection, asserting in Page 7 of the Remarks filed 15 December 2025 that Yivgi-Ohana et al do not disclose a pharmaceutical composition that comprises a purified human CD8 T cell, nor a method of making a pharmaceutical composition that comprises the isolation or enrichment of human CD8 T cells. In response, the Examiner respectfully submits that Yivgi-Ohana et al disclose a pharmaceutical composition that comprises an isolated human CD8 T cell and exogenous mitochondria, as well as a method of making the pharmaceutical composition thereof (Paragraphs [0033], [0036], [0055], [0136]-[0137], [0155]-[0162]). It is of note that the Examiner is interpreting the term “purified” to be equivalent to “isolated”, “sorted”, or “separated”, as detailed in Page 39 of the instant Specification filed 03 November 2023.
Therefore, Applicant’s arguments are not persuasive and the rejection is maintained and amended to encompass the claims as currently written.
New/Maintained Grounds of Rejection
Drawings
The drawings filed 15 December 2025 remain objected to for containing colored drawings in the DRW.SUPP file – particularly Figure 2D – without a granted petition for colored drawings.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The substitute Specification filed 15 December 2025 is acknowledged. However, because the petition under 37 CFR 1.84(a)(2) for colored drawings is still pending for review, the amendments to the Specification regarding the section heading “BRIEF DESCRIPTION OF THE DRAWINGS” have not been entered.
Claim Objections
Claims 101, 104, and 113 are objected to because of the following informalities:
Regarding claim 101: The instant claim is objected to for failing to recite “1)” in Line 1 prior to “a purified human CD8 T cell”, wherein the second and third components of the pharmaceutical composition are each numerically referenced.
Appropriate correction is required.
Regarding claim 104: The instant claim is objected to for reciting an extraneous comma following the recitation of “cell” in Line 1 of method step b). Applicant must delete this comma.
Appropriate correction is required.
Regarding claim 113: The instant claim is objected to for reciting an extraneous period at the end of the claim. Applicant must delete this period.
Appropriate correction is required.
Claim Interpretation
Under the broadest reasonable interpretation of each claim, all optional limitations are not required.
It is of note that Applicant has defined the term “increase” to refer to an increase of 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 87%, 90%, 95%, 98%, 99%, 100%, 1.5-fold, 2-fold, 2.5-fold, 3-fold, 3.5-fold, 4-fold, 4.5-fold, 5-fold, 5.5.-fold, 6-fold, 6.5- fold, 7-fold, 7.5-fold, 8-fold, 8.5-fold, 9-fold, 9.5-fold, 10-fold, 15-fold, 20-fold, 25-fold, 30-5 fold, 35-fold, 40-old, 45-fold, 50-fold, 55-fold, 60-fold, 65-fold, 70-fold, 75-fold, 80-fold, 85-fold, 90-fold, 95-fold, 100-fold, or greater in a recited variable. See Page 29, Lines 1-6 of the instant Specification filed 03 November 2023.
It is also of note that Applicant has defined the term “substantially purified” to refer to a cell that is essentially free of other cell types, or a cell which has been separated from other cell types with which it is normally associated in its naturally occurring state. See Page 39, Lines 20-22 of the instant Specification filed 03 November 2023. Accordingly, the Examiner is interpreting the term “purified” to be equivalent to “isolated”, “sorted”, or “separated”.
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 104, 114, and 116 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 claims 104, 114, and 116: Independent claim 104 fails to recite a preamble. Accordingly, the ordinary artisan cannot readily determine the metes and bounds of the claim, thus rendering the scope of the claim indefinite. Claims 114 and 116 are included within the rejection because they depend from rejected claim 104.
Appropriate correction is required.
For the sake of compact prosecution, the instant claim will be interpreted as a method of making a pharmaceutical composition, as was previously presented within the claims filed 16 July 2025.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 104, 114, and 116 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because independent claim 104 fails to recite a preamble. Claims 114 and 116 are included within the rejection because they depend from rejected claim 104.
As aforementioned, the instant claim will be interpreted as a method of making a pharmaceutical composition, as was previously presented within the claims filed 16 July 2025.
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 101-102, 104-106, 111-113, and 116 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yivgi-Ohana et al (US 2023/0123731 A1, of record). Yivgi-Ohana et al has an effective filing date of 13 March 2020.
Yivgi-Ohana et al disclose a pharmaceutical composition including mitochondrially-enriched, genetically engineered T cells and a pharmaceutically acceptable carrier, wherein the mitochondrially-enriched genetically engineered T cells are enriched with exogenous mitochondria (Abstract; Paragraphs [0013], [0040]-[0041]). Yivgi-Ohana et al further disclose that the genetically engineered T cells are chimeric T cell receptor (TCR) T cells or chimeric antigen receptor (CAR) T cells (Paragraphs [0016], [0033], [0050]-[0055], [0062]-[0063]).
Yivgi-Ohana et al further disclose that the T cells are derived from a human subject (Paragraphs [0024], [0059]). Yivgi-Ohana et al further disclose that the human T cells are mature CD8 T cells that have been isolated from a peripheral blood sample (Paragraphs [0033], [0036], [0055], [0136]-[0137]).
Yivgi-Ohana et al further disclose that the genetically engineered T cells have an increased rate of oxygen consumption relative to the corresponding level in the T cells prior to mitochondrial enrichment (Paragraphs [0018], [0038], [0116], [0141]). It is of note that Yivgi-Ohana et al define “increased” as a value which is 1.05 fold, 1.1 fold, 1.25 fold, 1.5 fold, 2 fold, 3 fold, 4 fold, 5 fold, 6 fold, 7 fold or higher than the corresponding value found in corresponding cells or corresponding mitochondria of a healthy subject or of a plurality of healthy subjects or in the cells (for example, T cells and genetically engineered T cells) prior to mitochondrial enrichment (Paragraph [0114]).
Yivgi-Ohana et al further disclose that the mitochondrially-enriched genetically engineered human CD8 T cells are produced by the method including isolating CD8 T cells from a human subject afflicted with a disease or disorder or a donor; obtaining exogenous mitochondria; producing mitochondrially-enriched human CD8 T cells by contacting the human CD8 T cells with the exogenous mitochondria under conditions allowing the exogenous mitochondria to enter the human CD8 T cells; and producing mitochondrially-enriched genetically engineered human CD8 T cells by introducing a nucleic acid encoding a chimeric TCR or CAR into the mitochondrially-enriched human CD8 T cells, wherein the mitochondrial content of the mitochondrially-enriched genetically engineered human CD8 T cells is detectably higher than the mitochondrial content of the unaltered human CD8 T cells. Yivgi-Ohana et al further disclose that the human CD8 T cells are contacted with the exogenous mitochondria at a ratio of about 0.088 - 176 mU citrate synthase (CS) activity per 106 T cells (Paragraphs [0014]-[0015], [0022]-[0023], [0033], [0036], [0046]-[0048], [0055], [0107]-[0109], [0136]-[0137], [0155]-[0162]).
Yivgi-Ohana et al further disclose that the pharmaceutical composition is formed by combining the genetically engineered human CD8 T cells that have been enriched with exogenous mitochondria, and a pharmaceutically acceptable carrier (Paragraphs [0033], [0036], [0040]-[0042], [0055], [0155]-[0162]).
Accordingly, Yivgi-Ohana et al anticipate the claims as follows:
Regarding claims 101 and 111: Yivgi-Ohana et al disclose a pharmaceutical composition comprising isolated human CD8 CAR-T cells (claim 111) that are enriched with exogenous mitochondria and a pharmaceutically acceptable carrier, wherein the exogenous mitochondria is administered to the human CD8 CAR-T cells in an amount effective to increase the oxygen consumption rate of the human CD8 CAR-T cells when compared to human CD8 CAR-T cells that have not been administered exogenous mitochondria. As the oxygen consumption rate is one of the defined “activities” of the T cells within the instant Specification filed 03 November 2023 (see Example 7), this therefore reads on the pharmaceutical composition of instant claim 101.
Regarding claims 102 and 105-106: Following the discussion of claim 101, Yivgi-Ohana et al further disclose that the rate of oxygen consumption relative to the corresponding level in the human CD8 T cells prior to mitochondrial enrichment is increased 1.1 fold (claims 105-106). As a 1.1 fold change equates to an increase of 10%, this therefore reads on the pharmaceutical composition of instant claim 102.
Regarding claim 104: Yivgi-Ohana et al disclose the formulation of a pharmaceutical composition, wherein CD8 T cells isolated from a human donor (instant steps a)-b)) are cultured with exogenous mitochondria to allow for the uptake of the exogenous mitochondria by the human CD8 T cells (instant step c)), and then formulated with a pharmaceutically acceptable carrier to generate the pharmaceutical composition (instant step d)). This therefore reads on the method of the instant claim.
Regarding claim 112: Following the discussion of claim 111, Yivgi-Ohana et al further disclose that the pharmaceutical composition comprising the mitochondrially-enriched human CD8 CAR-T cells are infused into a subject, wherein they engage with the antigens on the target cells (Paragraphs [0054]-[0056]). As the mitochondrially-enriched human CD8 CAR-T cells are interacting with the target cells, they will inherently have an increased expression of IL-2 mRNA, IFN-γ mRNA, TNF-α mRNA, Granzyme B mRNA, or a combination thereof when compared to a human CD8 CAR-T that has not been treated with exogenous mitochondria. See Example 14 on Pages 93-94 of the instant Specification filed 03 November 2025, and MPEP § 2112.01(II). This therefore reads on the pharmaceutical composition of the instant claim.
Regarding claim 113: Following the discussion of claim 101, Yivgi-Ohana et al further disclose that the pharmaceutical composition can also comprise isolated human CD4 T cells that express a CAR (Paragraphs [0033], [0036], [0136]-[0137]). This therefore reads on the pharmaceutical composition of the instant claims.
Regarding claim 116: Following the discussion of claim 104, Yivgi-Ohana et al further disclose that the exogenous mitochondria are isolated and intact, and that mitochondria are alive (Paragraphs [0025], [0038], [0090], [0118]). This therefore reads on the method of the instant claim.
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.
Claims 101-102, 104-106, 109-114, and 116 are rejected under 35 U.S.C. 103 as being unpatentable over Yivgi-Ohana et al (US 2023/0123731 A1) in view of Han et al (US 2019/0269731 A1, of record).
The discussion of Yivgi-Ohana et al regarding claims 101 and 104 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Yivgi-Ohana et al anticipate claims 101-102, 104-106, 111-113, and 116. Han et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claims 109-110 and 114: Following the discussions of claims 101 and 104 above, Yivgi-Ohana et al further disclose that the amount of exogenous mitochondria added to the genetically engineered T cells is about 0.088 - 176 mU citrate synthase (CS) activity per 106 cells (Paragraphs [0107]-[0109]).
Yivgi-Ohana et al do not disclose that the amount of exogenous mitochondria cultured with the human CD8 T cells is about 30 micrograms, as required by instant claim 114.
Han et al, however, disclose peripheral blood mononuclear cell (PBMC) therapy products, wherein the PBMCs comprise exogenous mitochondria, and pharmaceutical compositions comprising the same as an active ingredient (Paragraphs [0001], [0009], [0040]-[0042]). Han et al further disclose that the PBMCs are human T cells (Paragraphs [0003], [0041], [0072]).
Han et al further disclose that the PBMCs – including human T cells – are directly isolated from a blood sample of a subject, cultured together with the exogenous mitochondria to allow for the uptake of the exogenous mitochondria by the PBMCs, and then formulated with a pharmaceutically acceptable carrier to generate the pharmaceutical composition (Paragraphs [0041]-[0042], [0072]).
Han et al further disclose that the PBMC T cells comprised within the pharmaceutical are contacted with 2 to 10 micrograms of exogenous mitochondria per 105 cells (Paragraphs [0023]-[0024], [0042], [0072]-[0074] Figure 10). It is of note that this equates to 20 to 100 micrograms of exogenous mitochondria per 106 cells.
Therefore, it would have been prima facie obvious to have modified the method of Yivgi-Ohana et al such that the human CD8 T cells are cultured with about 30 micrograms of exogenous mitochondria per 106 cells, as detailed in Han et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to increase the cytotoxic capability of the cultured human CD8 T cells (Han et al: Paragraph [0074]; Figure 10), and would have had a reasonable expectation of success given that the disclosures of both Yivgi-Ohana et al and Han et al are concerned with the generation of a pharmaceutical composition comprising T cells that have been contacted with exogenous mitochondria. See MPEP § 2143(I)(G).
Consequently, Yivgi-Ohana et al as modified by Han et al render obvious a method of forming a pharmaceutical composition, wherein the isolated human CD8 T cells are cultured with about 30 micrograms of exogenous mitochondria per 106 cells. This therefore renders obvious the method of instant claim 114.
In addition, since the human T cells of the instant disclosure contacted with 30 micrograms or 100 micrograms of exogenous mitochondria per 106 cells showed a greater than 5% decrease in exhaustion markers (see Example 9 and Figure 6 of the instant disclosure), the human CD8 T cells rendered obvious by Han et al cultured with 20 to 100 micrograms of exogenous mitochondria will necessarily have the same characteristics and expression profile as the T cells of the instant disclosure. See MPEP § 2112.01(II). This therefore also renders obvious the pharmaceutical composition of instant claims 109-110.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633