DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Preliminary amendment filed on 07/06/2026 has been entered. Claims 1-12 are pending in this application. Claims 4-7 and 9-12 are withdrawn. Claims 1-3 and 8 are currently under examination.
Priority
This US application is 18/434,386 filed on 02/06/2024, which is a CIP of 18/150,464 filed on 01/05/2023, now PAT 12162819, and claims foreign priority of CHINA 202210478132.X filed on 04/29/2022, CHINA 202210478559.X filed on 04/29/2022, CHINA 202211319669.8 filed on 10/26/2022, and CHINA 202211419893.4 filed on 11/14/2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. U.S.C. 120, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 18/150,464, CHINA 202210478132.X, CHINA 202210478559.X, CHINA 202211319669.8, or CHINA 202211419893.4, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 1-3 and 8 recite “
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wherein Z is… N”, “R11 is selected from CN, -OR3, -C(O)R3, -OC(O)R3, -NRbC(O)R3, -NR3R4, -NRbC(O)NR3R4, -NRbC(O)R3, -NRbS(O)2R3, -OC(O)NR3R4, -NRbC(O)OR3, -N(ORb)C(O)R3, -N(ORb)S(O)2R3, -N(ORb)C(O)OR3, -N(ORb)C(O)R3R4, 3- to 14-membered heterocyclyl and 5- to 14-membered heteroaryl”, “R5 and R6 are taken together with the carbon atom to which they are attached to form C3-14 cycloalkylene or 3- to 14-membered heterocyclylene; or, R7 and R8 are taken together with the carbon atom to which they are attached to form C3-14 cycloalkylene or 3- to 14-membered heterocyclylene”, and/or “-(CH2)6-C(CH3)2-CH2-, -(CH2)5-C(CH3)2-CH2-, -(CH2)4-C(CH3)2-(CH2)2-, -(CH2)3-C(CH3)2-(CH2)3-, -(CH2)2-C(CH3)2-(CH2)4-, -(CH2)5-C(CH3)2-CH2-, -(CH2)3-C(CH3)2-CH2-, -(CH2)2-C(CH3)2-CH2-,
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,
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”, which are not disclosed or supported by the prior-filed Application No. 18/150,464, CHINA 202210478132.X, CHINA 202210478559.X, CHINA 202211319669.8, or CHINA 202211419893.4. Thus, the priority date of claims 1-3 and 8 is 02/06/2024.
Election/Restrictions
Applicant's election with traverse of Group I invention (claims 1-8) and species (
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) in the reply filed on 07/06/2026 is acknowledged. The traversal is on the ground(s) that “a search for one of the groups of inventions would likely result in finding art pertinent to the other group of inventions. As such, there would not be a serious search or examination burden” (p. 24, para. 3) and “there would be no burden if all of the species were searched and examined together” (p.25, para. 1). This is not found persuasive because " Inventions I/II are related as product and process of use... Invention II is directed to a generic process of administering to a subject the pharmaceutical composition, which can be practiced by with another materially different product, such as aspirin. Inventions I/III, I/IV, II/III, II/IV, and III/IV are unrelated… Invention II is directed to a method of using claim 8 composition and is distinct from the Invention III of delivering a load and the Invention IV of making formula (VIII). Thus, they are not disclosed as capable of use together and they have different designs and modes of operation” and “The species or groupings of patentably distinct species require a different field of search (e.g. searching multiple classes/subclasses or electronic resources, or employing different search strategy or search queries)”, as set forth on pages 3 to 5 of the Restriction/Election Requirement mailed on 05/06/2026. Claims 4-7 and 9-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Thus, claims 1-3 and 8 are currently under examination.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
Five information disclosure statement (IDS) filed on 04/26/2024, 08/30/2024, 02/11/2025, 07/09/2025, and 11/07/2025 with appropriate assertion under 37 CFR 1.98 have been considered.
Claim Objections
Claims 1-3 and 8 are objected to because of the following informalities: In claims 1-3, insert the missing phrase “the group consisting of” immediately after the recitation “selected from” (lines 6 and 10 of claim 1; line 1 on page 4; line 5 on page 5; lines 6 and 8 of claim 2, lines 9 and 10 on page 6; lines 4 and 6 of claim 3; line 9 on age 8; lines 7 and 18 on page 9) to comply with Markush group format ending with the conjunction “and” before the last species. In claim 2, also change the incorrect recitation “compound of formula (IV') of claim 1, or a pharmaceutically acceptable salt, isotopic variant, tautomer or stereoisomer thereof, which has” (lines 1 to 2) to “compound of claim 1, wherein the compound has” because the compound of claim 1 encompasses the “formula (IV’)” and “pharmaceutically acceptable salt, isotopic variant, tautomer or stereoisomer thereof”. In claim 3, also delete the excessive recitations “of formula (V')” (line 1) and “or a pharmaceutically acceptable salt, isotopic variant, tautomer or stereoisomer thereof,” (lines 1 to 2) because the compound of claim 2 encompasses the “formula (V’)” and “pharmaceutically acceptable salt, isotopic variant, tautomer or stereoisomer thereof”. In claim 8, change the incorrect recitation “compound of claim 1, or a pharmaceutically acceptable salt, isotopic variant, tautomer or stereoisomer thereof” (lines 1 to 2) to “compound of formula (IV’), or a pharmaceutically acceptable salt, isotopic variant, tautomer or stereoisomer thereof according to claim 1” because the compound of claim 1 encompasses the “formula (IV’)” and “pharmaceutically acceptable salt, isotopic variant, tautomer or stereoisomer thereof”. 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.
Claim 3 is 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.
Claim 3 recites “alternatively” (line 9 on page 8; line 6 on page 9), which is not specifically defined and is not clear to its scope. Applicant is advised to change the above recitation to conjunction “or”.
Claim Rejections - 35 USC § 102
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.
(I) Claims 1-3 and 8 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Zhang et al. (US 2023/0348361, published on Nov. 2, 2023 and filed on Jan. 5, 2023, the patented US 12,162,819 is used for citation here, hereinafter referred to as Zhang ‘361).
With regard to structural limitations “a compound of formula (IV’):
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(or formula (V’):
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; or elected
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), wherein Z is CH; M1 and M2 are independently -C(O)O-; Q is C(O)O-; G5 is a chemical bond; G6a and G6b are independently a chemical bond or C1-7 alkylene (or C1-5 alkylene); R9, R10 and R** are independently H; G1, G2, G3 and G4 are independently a chemical bond, C1-13 alkylene (or G1a, G1b, G2a, G2b, G3a, G3b, G4a and G4b are independently a chemical bond or C1-7 alkylene); R11 is -NR3R4; R3 and R4 are independently H, C1-10 alkyl (or C1-6 alkyl); R5, R6, R7 and R8 are independently C1-8 alkyl (or C1-6 alkyl); R1 and R2 are independently C4-20 alkyl (or G7, G8, G9 and G10 are independently a chemical bond or C1-12 alkylene; G7, G8, G9 and G10 are optionally and independently substituted with 1 R, R is independently H or C1-10 alkyl)” (claims 1-3) and “a pharmaceutical composition, comprising the compound according to claim 1 and pharmaceutically acceptable excipient” (claim 8):
Zhang ‘361 disclosed compound 46:
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. A pharmaceutical composition comprising the lipid compound and pharmaceutically acceptable excipient(s) (page 40/190; page 73/190, col. 143, lines 60-64).
(II) Claims 1-3 and 8 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Yang et al. (US 2023/0346702, published on Nov. 2, 2023 and filed on Jan. 5, 2023, the patented US 12,642,768 is used for citation here, hereinafter referred to as Yang ‘702).
With regard to structural limitations “a compound of formula (IV’):
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(or formula (V’):
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; or elected
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), wherein Z is CH; M1 and M2 are independently -C(O)O-; Q is C(O)O-; G5 is a chemical bond; G6a and G6b are independently a chemical bond or C1-7 alkylene (or C1-5 alkylene); R9, R10 and R** are independently H; G1, G2, G3 and G4 are independently a chemical bond, C1-13 alkylene (or G1a, G1b, G2a, G2b, G3a, G3b, G4a and G4b are independently a chemical bond or C1-7 alkylene); R11 is -NR3R4; R3 and R4 are independently H, C1-10 alkyl (or C1-6 alkyl); R5, R6, R7 and R8 are independently C1-8 alkyl (or C1-6 alkyl); R1 and R2 are independently C4-20 alkyl (or G7, G8, G9 and G10 are independently a chemical bond or C1-12 alkylene; G7, G8, G9 and G10 are optionally and independently substituted with 1 R, R is independently H or C1-10 alkyl)” (claims 1-3) and “a pharmaceutical composition, comprising the compound according to claim 1 and pharmaceutically acceptable excipient” (claim 8):
Yang ‘702 disclosed compound 46:
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. A pharmaceutical composition comprising the lipid compound and pharmaceutically acceptable excipient(s) (page 40/210; page 88/210, col. 173, lines 41-46).
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 1-3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Maier et al. (US 2013/0195920, Aug. 1,2013, hereinafter referred to as Maier ‘920).
With regard to structural limitations “a compound of formula (IV’):
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(or formula (V’):
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; or elected
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), wherein Z is CH; M1 and M2 are independently -C(O)O-; Q is C(O)O-; G5 is a chemical bond; G6a and G6b are independently a chemical bond or C1-7 alkylene (or C1-5 alkylene); R9, R10 and R** are independently H; G1, G2, G3 and G4 are independently a chemical bond, C1-13 alkylene (or G1a, G1b, G2a, G2b, G3a, G3b, G4a and G4b are independently a chemical bond or C1-7 alkylene); R11 is -NR3R4; R3 and R4 are independently H, C1-10 alkyl (or C1-6 alkyl); R5, R6, R7 and R8 are independently C1-8 alkyl (or C1-6 alkyl); R1 and R2 are independently C4-20 alkyl (or G7, G8, G9 and G10 are independently a chemical bond or C1-12 alkylene; G7, G8, G9 and G10 are optionally and independently substituted with 1 R, R is independently H or C1-10 alkyl)” (claims 1-3) and “a pharmaceutical composition, comprising the compound according to claim 1 and pharmaceutically acceptable excipient” (claim 8):
Maier ‘920 disclosed lipid particle compounds: first:
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; second:
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; and third:
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, r = 0-2, n = 0-5, m = 0-3, p = 0-5, and q = 0-5 (page 168/295; page 173/295; page 179/295). The size of the lipid nanoparticles was measured before and after undergoing dialysis overnight. In general, greater changes in lipid nanoparticle size are indicative of lesser stability.
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(page 275/295 to 276/295, [0536 to 0538]). The lipid particles, particularly when associated with a therapeutic agent, may be formulated as a pharmaceutical composition, e.g., which further comprises a pharmaceutically acceptable diluent, excipient, or carrier, such as physiological saline or phosphate buffer (page 211/295).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to optimize the length of alkyl chain with alkyl substitution on the left side of the C(O)O moiety and branched alkyl chain length on the right side of the C(O)O moiety to obtain proper hydrophobicity and nanoparticle stability as taught by Maier ‘920 because (a) the first compound above contains alkyl substitution with higher nanoparticle stability than one without the alkyl substitution, (b) the second compound above contains substitution with two fluorines, indicating that substitution with two alkyls is possible; and (c) the branched alkyl chains also increase nanoparticle stability, illustrated above. Thus, one of skill in the art would have a reasonable expectation that by optimizing the length of alkyl chain with alkyl substitution on the left side of the C(O)O moiety and branched alkyl chain length on the right side of the C(O)O moiety to obtain proper hydrophobicity and nanoparticle stability as taught by Maier ‘920, one would achieve Applicant’s claims 1-3 and 8. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 [R-01.2024] [II.A].
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.
(I) Claims 1-3 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, and 14 of U.S. Patent No. 12,162,819 (Zhang et al., published on Dec. 10, 2024). Although the claims at issue are not identical, they are not patentably distinct from each other because Pat ‘819 claims “A compound of formula (IV), or a pharmaceutically acceptable salt, isotopic variant, tautomer or stereoisomer thereof:
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… R5, R6, R7 and R8 are independently C1-2 alkyl… Rf and R’f are independently H or C1-10 alkyl (or the compound is selected from…
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…
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… or a pharmaceutically acceptable salt, isotopic variant, tautomer or stereoisomer thereof)” (claims 1 and 13), and “A pharmaceutical composition, comprising the compound of claim 1, or a pharmaceutically acceptable salt, isotopic variant, tautomer or stereoisomer thereof, and pharmaceutically acceptable excipient(s)” (claim 14), encompassed by or overlapped with claims 1-3 and 8 of this Application.
(II) Claims 1-3 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 22, and 32 of U.S. Patent No. 12,642,768 (Yang et al., published on Jun. 2, 2026). Although the claims at issue are not identical, they are not patentably distinct from each other because Pat ‘768 claims “A nanoparticle composition, comprising a lipid ingredient, and optionally comprising a load; wherein the lipid ingredient comprises the following components in the molar percentages: Ionizable cationic lipids 20 mol %-85 mol %; Structure lipids 10 mol %-75 mol %; Neutral lipids 1.0 mol %-30 mol %; Polymer lipids 0.25 mol %-10 mol %; wherein the ionizable cationic lipid is a compound of formula (IV), or a pharmaceutically acceptable salt, isotopic variant, tautomer or stereoisomer thereof:
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… R5, R6, R7 and R8 are independently C1-2 alkyl… Rf and R’f are independently H or C1-10 alkyl (or the ionizable cationic lipid is
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… Polymer lipids 1 mol %-3 mol %, alternatively 1 mol %-2 mol %.)” (claims 1 and 22), and “A pharmaceutical composition, comprising the nanoparticle composition of claim 1, and pharmaceutically acceptable excipient(s)” (claim 32), encompassed by or overlapped with claims 1-3 and 8 of this Application.
(III) Claims 1-3 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 29, 37, and 64 of copending Application No. 19/474,306 (Zhang et al., the claim set of 10/10/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because Appl ‘306 claims “A lipid nanoparticle comprising an ionizable lipid and a steroid compound… the alkyl and alkenyl are optionally substituted (or the ionizable lipid is a compound of formula (IV'):
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; or the ionizable lipid is:
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…
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… or a stereoisomer, a mixture of stereoisomers, or a pharmaceutically acceptable salt thereof)” (claims 1, 29, and 37), and “A pharmaceutical composition comprising the lipid nanoparticle of claim 1 and a pharmaceutically acceptable carrier” (claim 64), encompassed by or overlapped with claims 1-3 and 8 of this Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691