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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 4, 2026 has been entered.
Status of Claims/Rejections
Claims 1 and 4-16 are currently pending and under examination on the merits in the instant application.
Any rejections not repeated in this Office action are withdrawn, and the following rejections are the only rejections applied in this application.
Response to Arguments
Applicant’s arguments filed with the RCE on February 4, 2026 have been considered but are moot because they do not apply to the new rejections set forth hereinbelow.
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 4 and 10 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.
Claim 4 recites “wherein the six nucleotide sequences are selected from SEQ ID NO: 1-6.” However, the composition of claim 1 as written requires each of all of SEQ ID NOs:1-6 or the sequences having at least 95-99% identity thereof. Since the phrase “selected from” imparts a meaning that the six nucleotide sequences can be six of SEQ ID NO:1, for instance, the structural limitations in claim 4 are inconsistent and indefinite.
For examination purpose, the wherein clause in claim 4 will be interpreted as wherein the six nucleotide sequences are SEQ ID NOs:1-6.
Claim 10 recites “SEQ ID NO: 10” to refer to a peptide comprising K10 flanked by two copies of an aurein 1.2 peptide, which is identified as SEQ ID NO:12, which is “GLFDIIKKIAESF”.
SEQ ID NO:10 is reproduced from the sequence listing as below.
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As shown above, SEQ ID NO:10 appears to comprise two “GSG” linkers and one aurein 1.2 peptide (SEQ ID NO:12; see boxed). As such, SEQ ID NO:10 does not have two copies of SEQ ID NO:12 flanking K10. Hence, claim 10 recites structurally inconsistent limitations pertaining to the peptide, thereby rendering the claim indefinite.
For examination purpose, SEQ ID NO:10 will be interpreted as SEQ ID NO:13, which appears to satisfy the structural limitations.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 recites that the number of aurein 1.2 peptide of SEQ ID NO:12 in the single DNA nanostructure is about 40-50, wherein the DNA nanostructure is further functionalized with K10 that is present in SEQ ID NO:13. Note that claim 11 depends from claim 10 that requires SEQ ID NO:13. See the claim interpretation above. That is, claim 11 requires that the single DNA nanostructure should be functionalized with at least about 20-25 copies of SEQ ID NO:13, which comprises two copies of SEQ ID NO:12 each flanking K10.
The instant specification does not provide any actual DNA nanostructure comprising about 20-25 copies of SEQ ID NO:13. In fact, the specification expressly discloses that the exemplified, actually synthesized DNA nanostructure is coated with “~48 copies of the aurein 1.2 peptide”, wherein “the DN was coated with an 80:20 ratio of the EE peptide and K10 labeled with the pH-sensitive dye pHrodo Red”. See page 18. It is noted that “EE” peptide is identified as SEQ ID NO:13 as evidenced by the disclosure of “SEQ ID NO: 13 which was termed “EE”)” at page 13 of the specification. Hence, the instant specification at best describes a DNA coated with the combination of SEQ ID NO:13 and K10 (SEQ ID NO:7) at the ratio of 80:20, which consequently provides about 48 copies of aurein 1.2 peptide (SEQ ID NO:12). As such, the DNA nanostructure described in the specification differs from the claimed structure, and furthermore, the number of about 48 copies of SEQ ID NO:12 does not describe lower number copies such as “about 40” claimed in the instant case.
Accordingly, the instant specification does not describe the structure of claim 11 as being currently claimed and the specification also fails to reasonably convey that the instant inventor had possession of the entire genus of the claimed structure as of the filing date sought in the instant application.
For examination purpose, claim 11 will be interpreted as being functionalized with the combination of SEQ ID NO:13 and SEQ ID NO:7 as disclosed in the specification.
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 and 4-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smolková et al. (Applied Materials & Interfaces, published on September 27, 2021, 13:46375-46390, of record).
Smolková discloses a 6HB DNA nanostructure formed by six DNA nucleotide sequences in Figure 1a as reproduced below.
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It is noted that the above 6HB DNA nanostructure of Smolková is formed by six nucleotide sequences corresponding to and identical to SEQ ID NOs:1-6 claimed in the instant case.
Smolková teaches that the 6HB DNA nanostructure is conjugated to “EE” (“K10-[aurein 1.2]2”) comprising “a peptide flanking K10 with two copies of a sequence termed aurein 1.2, which was found to facilitate endosomal escape”, wherein aurein 1.2 is “a 13-residue peptide” of “GLFDIIKKIAESF”, wherein the 6HB is “a rigid and monomeric assembly roughly 7 x 6 nm2 in size” and “There are ~48 copies of the aurein 1.2 peptide per DN”, and wherein “DNAs remain largely stable in lysosomal compartments for up to 24 h of incubation.” See pages 46376 and 46382.
Smolková discloses the “mean hydrodynamic diameters of about 15, 25, and 28 nm for 6HB, K10, and EE” and the “electrostatic interactions” between the 6HB and EE “at a nitrogen/phosphate (N/P) ratio of ~1”. See page 46378.
Smolková discloses that the 6HB DNA nanostructure can be coated/functionalized with “the EE peptide and K10”, thereby providing “~48 copies of the aurein 1.2 peptide per DN.” See page 46382.
Smolková teaches that DNA nanostructure can be designed for “delivery of therapeutic agents.” See abstract.
Accordingly, claims 1 and 4-16 are described by Smolková et al.
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.
Claims 1, 4-10, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Howorka et al. (WO 2022/064202 A1) in view Pei et al. (Bioconjugate Chemistry, 2019, 30:273-283, applicant’s citation), Yang et al. (RSC Advances, 2020, 10:29469-29474), and de Mello et al. (The Journal of Physical Chemistry B, 2019, 123:8861-8871).
Howorka discloses a DNA nanobarrel that is “composed of six DNA duplexes which are interlinked to form a six-helical bundle measuring 9 x 5 x 5 nm”, wherein the six DNA duplexes are formed by SEQ ID NOs:1-6, which are “self-assembled” to form the DNA nanobarrel by “annealing”, wherein the DNA nanobarrel is useful “as delivery platform.” See pages 26-30. See also SEQ ID NOs:1-6 listed in Table 1 of Howorka as reproduced below.
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It is noted that Howorka’s SEQ ID NOs:1-6 are 100% identical to SEQ ID NOs:1-6 claimed in the instant application, respectively.
Howorka does not teach that the DNA nanobarrel is functionalized with polylysine (K10) and aurein 1.2 peptide (SEQ ID NO:12).
Pei teaches that “a 13-residue peptide, aurein 1.2 (GLFDIIKKIAESF)” is a cell penetrating peptide (CPP) that “enhanced endosomal escape” and “dramatically improved the cytosolic delivery efficiency” for instance “by up to ~5 fold.” See page 279.
Pei teaches that “dimerization” or “oligomerization” of peptides is “another effective strategy to enhance endosomal escape”, wherein a dimerization of an endosomal escape peptide “vastly improved its endosomal escape efficiency” and also improved “the overall cytosolic delivery efficiency.” See page 279.
Yang teaches that “multidomain peptides (MDPs)” comprising the cell penetrating peptide (CPP) of 10 lysines (K10) and other CPPs have the ability “to escape from the lysosomes to reach cytoplasm, which was an important attribute for the design of highly effective intracellular therapeutic delivery vehicles.” See page 29473; Table 1.
de Mello teaches that the “N+:P- ratio” of “1:1” between the “cationic charges” on the cell penetrating peptides (CPP) and the “anionic charges at phosphate groups of the DNA” of a DNA nanostructure “produces self-assemblies with the smoothest interfaces” and “the highest compactness” when 1:1, 1:2, and 2:1 ratios were tested. See pages 8862-8864.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Howorka’s “six helical” DNA nanobarrel formed by SEQ ID NOs:1-6 by functionalizing the DNA nanobarrel with Pei’s “aurein 1.2 (GLFDIIKKIAESF)”. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to design Howorka’s DNA nanobarrel as a drug delivery vehicle that is delivered to the cell cytoplasm because the DNA nanobarrel formed by SEQ ID NOs:1-6 was known to be useful “as delivery platform” as taught by Howorka, and because the cell penetrating peptide (CPP) of “GLFDIIKKIAESF” functioning as an endosomal escape peptide sequence was known to be useful for aiding and “dramatically” improving “cytosolic delivery efficiency” as evidenced by Pei’s teachings. It would also have been obvious to one of ordinary skill in the art before the effective filing date to functionalize Howorka’s DNA nanobarrel with a dimerized aurein 1.2 peptide linked by K10 at 1:1 N/P ratio instead of the individual aurein 1.2 peptides alone. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success so as to further or “vastly” enhance the cytoplasmic drug delivery vehicle utility of Howorka’s DNA nanobarrel because making oligomerized/dimerized peptides or multidomain peptides comprising different CPPs was deemed “another effective strategy to enhance endosomal escape”, thereby enabling design of “highly effective intracellular therapeutic delivery vehicles” as evidenced by the teachings of Pei and Yang, wherein Yang taught that the inclusion of 10 lysines (K10) with other CPPs improved “escape from the lysosomes to reach cytoplasm” and Pei taught that oligomerized/dimerized CPPs “vastly improved its endosomal escape efficiency” as well as “the overall cytosolic delivery efficiency.” As such, a person of ordinary skill in the art would have had a reasonable expectation of success in making a dimerized or oligomerized fusion CPP for further enhancing cytoplasmic delivery function by combining two copies of “aurein 1.2 (GLFDIIKKIAESF)” and K10 such that the two copies of aurein 1.2 forms a dimerized structure that is connected by K10, wherein the person of ordinary skill in the art would have had a reasonable expectation of success in functionalizing Howorka’s DNA nanobarrel with the multidomain or oligomerized/dimerized fusion CPPs having two copies of aurein 1.2 in combination with K10 as arranged in claim 10. When functionalizing Howorka’s “six helical” DNA nanobarrel with two copies of dimerized aurein 1.2 connected by K10, one of ordinary skill in the art would have been motivated to mix the DNA formed by Howorka’s SEQ ID NOs:1-6 with the fusion CPP peptides at 1:1 N/P ratio so as to provide self-assembly of the functionalized DNA nanobarrel with smooth interfaces and high compactness because it was art-recognized knowledge that the “N+:P- ratio” of “1:1” between the “cationic charges” on the cell penetrating peptides (CPP) and the “anionic charges at phosphate groups of the DNA” of a DNA nanostructure “produces self-assemblies with the smoothest interfaces” and “the highest compactness” when 1:1, 1:2, and 2:1 ratios were tested as taught by de Mello, thereby suggesting that the 1:1 N/P ratio is preferred.
Since Howorka’s DNA nanobarrel functionalized with an “endosomal escape peptide sequence” fully satisfies the structure of claim 5, it is deemed that the nanostructure would be inherently “rigid” and have the recited size in claim 5, absent objective evidence to the contrary. In addition, since all structural limitations set forth in claim 1 is fully satisfied by the functionalized DNA nanobarrel rendered obvious in the instant rejection, it necessarily follows that the DNA nanobarrel rendered obvious in the instant rejection is inherently deemed to be “stable in intracellular lysosomal compartments for up to 24 hr of incubation”, absent objective evidence to the contrary.
Accordingly, claims 1, 4-10, and 12-16 taken as a whole would have been prima facie obvious before the effective filing date.
Claims 1, 4-10, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Burns et al. (Nature Nanotechnology, 2016, 11:152-156, applicant’s citation; “Supplementary Information” attached herewith) in view of Pei et al. (Bioconjugate Chemistry, 2019, 30:273-283, applicant’s citation), Yang et al. (RSC Advances, 2020, 10:29469-29474), and de Mello et al. (The Journal of Physical Chemistry B, 2019, 123:8861-8871).
Burns teaches making a DNA nanopore with a “2-nm-wide channel” having a “six-helix-bundle architecture” comprising six DNA duplexes or “six concatenated DNA strands”, wherein two strands anneal and form each duplex, wherein the duplexes are formed by six “50 nt length” nucleotide sequences in Supplementary Table 1, wherein the DNA nanopore has a length of about 9 nm and the width of about 5 nm. See page 152; Figure 1b; Supplementary Figs. 1A and 2.
See “Supplementary Table 1” in the attached “Supplementary Information”, wherein the six nucleotide sequences forming the “DNA nanopore” in Figure 1 are shown below.
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It is noted that the ID numbers 1-6 listed above are 100% identical to SEQ ID NOs:1-6 claimed in the instant application, respectively.
Burns teaches that the DNA nanopore is functionalized with “hydrophobic cholesterol groups” to enable transport/release of small molecules into the cell, wherein the DNA nanopore can function as a “small-molecule cargo”. See pages 152 and 155.
Burns does not teach that the DNA nanopore is functionalized with polylysine (K10) and aurein 1.2 peptide (SEQ ID NO:12).
Pei teaches that “a 13-residue peptide, aurein 1.2 (GLFDIIKKIAESF)” is a cell penetrating peptide (CPP) that “enhanced endosomal escape” and “dramatically improved the cytosolic delivery efficiency” for instance “by up to ~5 fold.” See page 279.
Pei teaches that “dimerization” or “oligomerization” of peptides is “another effective strategy to enhance endosomal escape”, wherein a dimerization of an endosomal escape peptide “vastly improved its endosomal escape efficiency” and also improved “the overall cytosolic delivery efficiency.” See page 279.
Yang teaches that “multidomain peptides (MDPs)” comprising the cell penetrating peptide (CPP) of 10 lysines (K10) and other CPPs have the ability “to escape from the lysosomes to reach cytoplasm, which was an important attribute for the design of highly effective intracellular therapeutic delivery vehicles.” See page 29473; Table 1.
de Mello teaches that the “N+:P- ratio” of “1:1” between the “cationic charges” on the cell penetrating peptides (CPP) and the “anionic charges at phosphate groups of the DNA” of a DNA nanostructure “produces self-assemblies with the smoothest interfaces” and “the highest compactness” when 1:1, 1:2, and 2:1 ratios were tested. See pages 8862-8864.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Burns’ DNA nanopore of “six-helix-bundle architecture” formed by six sequences in Supplementary Table 1 by functionalizing the DNA nanopore with Pei’s “aurein 1.2 (GLFDIIKKIAESF)”. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to design Burns’ DNA nanopore as a small molecule drug delivery vehicle that is delivered to the cell cytoplasm because Burns’ DNA nanopore was known to be useful to transport and deliver a “small-molecule cargo” as taught by Burns, and because the cell penetrating peptide (CPP) of “GLFDIIKKIAESF” functioning as an endosomal escape peptide sequence was known to be useful for aiding and “dramatically” improving “cytosolic delivery efficiency” as evidenced by Pei’s teachings. It would also have been obvious to one of ordinary skill in the art before the effective filing date to functionalize Burns’ DNA nanopore with a dimerized aurein 1.2 peptide linked by K10 at 1:1 N/P ratio instead of the individual aurein 1.2 peptides alone. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success so as to further or “vastly” enhance the cytoplasmic small molecule drug delivery vehicle utility of Burns’ DNA nanopore because making oligomerized/dimerized peptides or multidomain peptides comprising different CPPs was deemed “another effective strategy to enhance endosomal escape”, thereby enabling design of “highly effective intracellular therapeutic delivery vehicles” as evidenced by the teachings of Pei and Yang, wherein Yang taught that the inclusion of 10 lysines (K10) with other CPPs improved “escape from the lysosomes to reach cytoplasm” and Pei taught that oligomerized/dimerized CPPs “vastly improved its endosomal escape efficiency” as well as “the overall cytosolic delivery efficiency.” As such, a person of ordinary skill in the art would have had a reasonable expectation of success in making a dimerized or oligomerized fusion CPP for further enhancing cytoplasmic delivery function by combining two copies of “aurein 1.2 (GLFDIIKKIAESF)” and K10 such that the two copies of aurein 1.2 forms a dimerized structure that is connected by K10, wherein the person of ordinary skill in the art would have had a reasonable expectation of success in functionalizing Burns’ DNA nanopore with the multidomain or oligomerized/dimerized fusion CPPs having two copies of aurein 1.2 in combination with K10 as arranged in claim 10. When functionalizing Burns’ DNA nanopore of the “six-helix-bundle architecture” with two copies of dimerized aurein 1.2 connected by K10, one of ordinary skill in the art would have been motivated to mix the DNA formed by Burns’ six sequences in Supplementary Table 1 with the fusion CPP peptides at 1:1 N/P ratio so as to provide self-assembly of the functionalized DNA nanopore with smooth interfaces and high compactness because it was art-recognized knowledge that the “N+:P- ratio” of “1:1” between the “cationic charges” on the cell penetrating peptides (CPP) and the “anionic charges at phosphate groups of the DNA” of a DNA nanostructure “produces self-assemblies with the smoothest interfaces” and “the highest compactness” when 1:1, 1:2, and 2:1 ratios were tested as taught by de Mello, thereby suggesting that the 1:1 N/P ratio is preferred.
Since Burns’ six-helical DNA nanopore functionalized with an “endosomal escape peptide sequence” fully satisfies the structure of claim 5, it is deemed that the nanostructure would be inherently “rigid” and have the recited size in claim 5, absent objective evidence to the contrary. In addition, since all structural limitations set forth in claim 1 is fully satisfied by the functionalized DNA nanopore rendered obvious in the instant rejection, it necessarily follows that the DNA nanopore rendered obvious in the instant rejection is inherently deemed to be “stable in intracellular lysosomal compartments for up to 24 hr of incubation”, absent objective evidence to the contrary.
Accordingly, claims 1, 4-10, and 12-16 taken as a whole would have been prima facie obvious before the effective filing date.
Double Patenting - Nonstatutory
Claims 1 and 4-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 19/508,520.
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 ‘520 claims that are drawn to and require a nanoparticle composition comprising a DNA nanostructure functionalized with K10 peptide and aurein 1.2 peptide, wherein the DNA nanostructure comprises DNA helixes formed by SEQ ID NOs:1-6, which are 100% identical to SEQ ID NOs:1-6 claimed in the instant case.
Double Patenting - Statutory
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1 and 4 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 3-4 of copending Application No. 19/508,520 (reference application). Although the claim language is not exactly identical between the conflicting claims, the subject matter with the recited structural limitations between the conflicting claims appears identical.
Conclusion
No claim is allowed.
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/DANA H SHIN/Primary Examiner, Art Unit 1635