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/Restrictions
Applicant’s election without traverse of claims 2-12 and 17 with species election of SEQ ID NO:13 (miR-515 agomir) and dotriacontahexaenoic acid in the reply filed on January 21, 2026 is acknowledged.
Status of Claims
Claims 1-21 are currently pending in the instant application. Claims 13-16 and 18-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Accordingly, claims 1-12 and 17 are under examination on the merits in the instant application.
Specification
The abstract of the disclosure is objected to because the word “novel” is not descriptive of an invention. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See paragraphs 0053, 0096, and 0098. 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.
Drawings
The drawings are objected to because FIG. 1 contains an embedded hyperlink and/or other form of browser-executable code. 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.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - Improper Markush Grouping
Claims 5-6 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination of process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP §706.03(y).
Note that “the phrase "Markush claim” means any claim that recites a list of alternatively useable species regardless of format.” See MPEP §2173.05(h).
The Markush grouping of a miR-22 antagomir and a miR-515 agomir is improper because the two alternatives do not share a substantial nucleotide sequence identity with each other as evidenced by the distinct, different nucleotide sequences of SEQ ID NO:12 representing the miR-22 antagomir and SEQ ID NO:13 representing the miR-515 agomir, nor do they share a substantial common use flowing from a substantially shared nucleotide sequence similarity.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternatives within a single claim in fact share a single structural similarity as well as a common use.
Claim Objections
Claim 9 is objected to because of the following informalities: “(FAT))” in line 2 should be “(FAT)”. 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 5-6 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 5-6 each recite “miR-515 agomir”, and claim 6 identifies “miR-515 agomir” as SEQ ID NO:13.
It is noted that the instant specification expressly discloses “miR-515” and “miR-515-3p” as two distinct miRNAs as separately listed in Table 1 as shown below. See the arrows added.
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Now, it is noted that SEQ ID NO:13 expressly claimed for “miR-515 agomir” in claim 6 is an art-recognized nucleotide sequence for miR-515-3p as evidenced by SEQ ID NO:1 of Jakob et al. (US 2023/0242911 A1), which is reproduced below.
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As such, “miR-515” that is claimed in the instant case appears to be in fact “miR-515-3p”, which is disclosed as being a distinct miRNA from “miR-515” that is instantly recited. Hence, the term/name “miR-515” claimed in claims 5-6 fails to particularly point out and distinctly claim the actual subject matter, miR-515-3p.
For examination purpose, “miR-515” will be interpreted as “miR-515-3p” based on the nucleotide sequence information pertaining to SEQ ID NO:13.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 7-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stoffel et al. (US 2007/0213292 A1) as evidenced by Zhou et al. (The FASEB Journal, 2012, 26:4733-4742, applicant’s citation).
It is noted that “palmitic acid” claimed in claim 8 is described as a long chain fatty acid in the instant specification. See paragraph 0020.
It is noted that “FAT” claimed in claim 9 and claim 12 is also known as “CD36” as disclosed in paragraph 0019 of the instant specification.
Stoffel teaches making a composition comprising a 22-mer miR-122 inhibitor oligonucleotide (antagomir-122; 5’-ACAAACCCAUUGUCACACUCCA) that is conjugated via a linker/spacer to “functional molecular entities” such as “a lipophilic moiety, e.g., cholesterol” and “palmitic acid” and that “enhances entry of the antogmir” into hepatocytes in the liver or cells in the pancreas, wherein the oligonucleotide can comprise modifications such as “peptide nucleic acid (PNA)” and the linker/spacer includes “disulfide”. See paragraphs 0079, 0099, 0176, 0179, and 0310.
Stoffel does not expressly teach that the “palmitic acid” lipophilic moiety that is the functional moiety linked to the miR-122 inhibitor oligonucleotide binds and is transported by FAT, which is also known as CD36. However, it was an art-recognized scientific fact/knowledge that CD36 is a receptor that recognizes and binds long-chain fatty acids (FAs) and CD36 plays a role in “FA transport”, wherein “[i]n adipocytes, CD36 is a key facilitator of FA uptake” as evidenced by the teachings of Zhou. See pages 4733-4734 and 4737-4738. Hence, Stoffel’s composition comprising a palmitic acid conjugate would inherently bind to and be transported by CD36, also known as FAT in view of the art-recognized scientific fact/knowledge pertaining to CD36’s inherent function of binding to and transporting long-chain fatty acids in adipocytes as disclosed in Zhou.
Accordingly, claims 1-4 and 7-12 are described by Stoffel et al.
Claims 1-8, 10-11, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thibonnier (US 2013/0331433 A1) as evidenced by Jakob et al. (US 2023/0242911 A1).
Thiobonnier teaching making a composition comprising an agomir of “hsa-miR-515-3p”, which is covalently linked to a targeting moiety that delivers the agomir to adipocytes or liver cells such as hepatocytes, wherein the targeting moiety includes “lipid moieties such as a cholesterol moiety” and the linker includes “biotinstepretavidin bridge”, and the agomir is 19, 20, 21, or 22 nucleotides in length comprising “the same or similar nucleic acid sequence to a miRNA” and comprises modifications including “peptide nucleic acid (PNA)”, wherein the agomir modulates mitochondrial activity. See paragraphs 0010, 0034, 0042, 0088, 0091, 0117, 0127, 0132-0133, 0140; claims 30-32 and 35-37.
Thibonnier does not expressly disclose the nucleotide sequence of “hsa-miR-515-3p”. However, it is an art-recognized scientific fact that miR-515-3p is a 22-mer sequence of 5’-GAGUGCCUUCUUUUGGAGCGUU as evidenced by SEQ ID NO:1 of Jakob.
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It is noted Jakob’s SEQ ID NO:1 is 100% identical to SEQ ID NO:13 claimed in claim 6.
Accordingly, claims 1-8, 10-11, and 17 are described by Thibonnier.
Claims 1-12 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thibonnier (US 2021/0145745 A1) as evidenced by Jakob et al. (US 2023/0242911 A1).
Thibonnier teaches making a composition comprising “miR-515 agomir”, which is linked via a covalent bond linker or a disulfide bond linker to dotriacontahexaenoic acid, which delivers the agomir “to a targeted adipocyte” and “is naturally transported by fatty acid translocase”, wherein the agomir is “22 nucleotides in length” with the same nucleic acid sequence of miR-515 or “hsa-miR-515-3p” and modulates “lipid oxidation”, wherein the agomir is modified with “peptide nucleic acid (PNA).” See paragraphs 0013-0015, 0018-0019, 0036, 0069, 0082, 0102-0103, 0108; claims 1-21.
Thibonnier does not expressly disclose the nucleotide sequence of “hsa-miR-515-3p” that constitutes the “miR-515 agomir”. However, it is an art-recognized scientific fact that hsa-miR-515-3p is a 22-mer sequence of 5’-GAGUGCCUUCUUUUGGAGCGUU as evidenced by SEQ ID NO:1 of Jakob.
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It is noted Jakob’s SEQ ID NO:1 is 100% identical to SEQ ID NO:13 claimed in claim 6.
Accordingly, claims 1-12 and 17 are described by Thibonnier.
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 1-12 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9,034,839 B2 in view of Thibonnier (US 2021/0145745 A1) and Jakob et al. (US 2023/0242911 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2, 5, 7-8, and 10-12 are anticipated and encompassed by the ‘839 patent claims that require a miRNA agent that is “hsa-miR-515-3p” or “an agomir of hsa-miR-515-3p” that “is linked to” a “targeting moiety”, which “delivers the miRNA agent to a specific cell type or tissue” including “adipocyte”, “hepatocyte”, and “myocyte”. It is noted that scope of the term “linked to” claimed in the ‘839 patent claims comprises a noncovalent “linker” including “a biotinsteptavin bridge” and the scope of the term “targeting moiety” claimed in the ‘839 patent claims reads on “lipid moieties such as a cholesterol moiety” as well as a moiety that binds to “FAT (CD36)” as disclosed in the ‘839 patent specification. Regarding claims 3-4, 6, 9, and 17, is was known in the art that the nucleotide sequence of miR-515-3p is a 22-mer of SEQ ID NO:13 claimed in the instant case as evidenced by the disclosure of Jakob (see SEQ ID NO:1) and furthermore, it was known in the art that dotriacontahexaenoic acid is a fatty acid that is known to deliver a PNA-modified agomir “to a targeted adipocyte” and “is naturally transported by fatty acid translocase”, wherein the fatty acid can be linked to the agoamir via a disulfide bond linker as taught by Thibonnier, who also taught that “hsa-miR-515-3p” modulates “lipid oxidation”.
Claims 1-5, 7-12, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,453,224 B2 in view of Thibonnier (US 2021/0145745 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2, 5, 7-8, 10-12, and 17 are anticipated and encompassed by the ‘224 patent claims that require an “antagomir” of miR-22 that “is linked to” a “targeting moiety”, which “delivers the miRNA agent to a specific cell type or tissue” including “subcutaneous adipose tissue”, wherein the miRNA agent modulates mitochondrial activity. It is noted that scope of the term “linked to” claimed in the ‘224 patent claims comprises a noncovalent “linker” including “a biotinsteptavin bridge” and the scope of the term “targeting moiety” claimed in the ‘224 patent claims reads on “lipid moieties such as a cholesterol moiety” as well as a moiety that binds to “FAT (CD36)” as disclosed in the ‘224 patent specification. Regarding claims 3-4 and 9, it would have been obvious to use at least a 14-mer antagomir that is modified with PNA and conjugated with dotriacontahexaenoic acid that is transported to adipocytes by FAT for the antagomir of the ’224 patent claims because such design was an art-recognized antagomir design as evidenced by Thibonnier.
Claims 1-5, 7-12, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,803,203 B2 in view of Thibonnier (US 2021/0145745 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2, 5, 7-8, 10-12, and 17 are anticipated and encompassed by the ‘203 patent claims that require an “antagomir” of miR-22 that “is linked to a targeting moiety”, which “delivers the miRNA agent to a specific cell type, organ or tissue”, wherein the antagomir modulates mitochondrial activity. It is noted that scope of the term “linked to” claimed in the ‘203 patent claims comprises a noncovalent “linker” including “a biotinsteptavin bridge” in view of the ‘203 patent specification; the scope of the term “targeting moiety” claimed in the ‘203 patent claims reads on “lipid moieties such as a cholesterol moiety” as well as a moiety that binds to “FAT (CD36)” as disclosed in the ‘203 patent specification; and the scope of the “specific cell type” claimed in the ‘203 patent claims is defined to read on “adipocytes” as disclosed in the ‘203 patent specification. Regarding claims 3-4 and 9, it would have been obvious to use at least a 14-mer antagomir that is modified with PNA and conjugated with dotriacontahexaenoic acid that is transported to adipocytes by FAT for the antagomir of the ’203 patent claims because such design was an art-recognized antagomir design as evidenced by Thibonnier.
Claims 1-5, 7-12, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,253,319 B2 in view of Thibonnier (US 2021/0145745 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5, 7-8, and 10-12 are anticipated and encompassed by the ‘319 patent claims that require an “antagomir” miR-22 of “18 nucleotides in length” comprising “peptide nucleic acid modification”, “wherein the antagomir is linked to a targeting moiety that specifically binds to CD36/Fatty Acid Transporter (FAT/SR-B2”, which “delivers the antagomir to adipose tissue.” It is noted that scope of the term “linked to” claimed in the ‘319 patent claims comprises a noncovalent “linker” including “a biotinsteptavin bridge” in view of the ‘319 patent specification and the scope of the term “targeting moiety” claimed in the ‘319 patent claims reads on “lipid moieties such as a cholesterol moiety” as disclosed in the ‘319 patent specification. Regarding claims 9 and 17, it would have been obvious to use dotriacontahexaenoic acid for the targeting moiety of the ‘319 patent claims because one of ordinary skill in the art would have reasonably recognized that dotriacontahexaenoic acid qualifies as the targeting moiety of the ‘319 patent claims as it was known to bind to and be transported to adipocytes by FAT as taught by Thibonnier, who also taught that an antagomir of miR-22 modulates lipid oxidation.
Claims 1-12 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,690,804 B2 as evidenced by Jakob et al. (US 2023/0242911 A1) and in view of Thibonnier (US 2021/0145745 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-3, 5-12, and 17 are anticipated and encompassed by the ‘804 patent claims that require to a therapeutic agent of “miR-515 agomir” of up to “22 nucleotides in length” linked/conjugated via a covalent bond linker to a fatty acid, which is “dotriacontahexaenoic acid”, which “specifically binds to Fatty Acid Translocase” and has the function of “facilitating cellular uptake and delivery of the therapeutic agent to a targeted adipocyte”, wherein the therapeutic agent modulates lipid oxidation. It is noted that the ‘804 patent specification discloses that “hsa-miR-515-3p” is used in the method. It would have been prima facie apparent that the 22-mer miR-515 agomir that is miR-515-3p used in the ‘804 patent claims has SEQ ID NO:13 claimed in the instant case in view of the art-recognized fact that miR-515-3p has the sequence of SEQ ID NO:13 as evidenced by Jakob’s SEQ ID NO:1. Regarding claim 4, it would have been obvious to modify the “miR-515 agomir” of the ‘804 patent claims with PNA because making a PNA-modified miR-515 agomir was already known in the art as taught by Thibonnier.
Claims 1-5, 7-12, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,286,625 B2 in view of Thibonnier (US 2021/0145745 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by and overlap in scope with the ‘625 patent claims drawn to a miR-22 antagonist of 18 or 22 nucleotides in length linked/conjugated to a fatty acid, which is “dotriacontahexaenoic acid.” It would have been obvious to modify the antagonist of the ‘625 patent claims with PNA and use a disulfide linker for the dotriacontahexaenoic acid linkage in view of the teachings of Thibonnier, who also taught that dotriacontahexaenoic acid is a fatty acid that “is naturally transported by fatty acid translocase” and that miR-22 antagomir modulates “lipid oxidation”.
Claims 1-12 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 16-24 of copending Application No. 17/656,901 in view of Thibonnier (US 2021/0145745 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by and overlap in scope with the ‘901 claims that are drawn to a therapeutic agent of “miRNA oligonucleotide therapeutic” that is miRNA “agomir” of up “to 23 nucleotides in length” linked via a covalent bond linker to “a fatty acid” that “binds to Fatty Acid Translocase” and also binds to “an adipocyte.” It is noted that the scope of the “fatty acid” binding to FAT claimed in the ‘901 claims is expressly disclosed as reading on “Dotriacontahexaenoic Acid” as disclosed in the ‘901 specification. For the miR-515 agomir claimed in the instant case, it would have been obvious to use Thibonnier’s PNA-modified miR-515 agomir for the ”miRNA oligonucleotide therapeutic” claimed in the ‘901 claims because PNA-modified miR-515 agomir was taught to be a useful therapeutic agent for modulating lipid oxidation as taught by Thibonnier, who also taught that dotriacontahexaenoic acid is a fatty acid that “is naturally transported by fatty acid translocase”.
Conclusion
No claim is allowed.
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/DANA H SHIN/Primary Examiner, Art Unit 1635