DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 for the cited rejections 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.
3. Response to Election/Restriction filed on 11/25/2025 is acknowledged.
4. Claim filed on 4/23/2023 is acknowledged.
5. Claims 1-13 are pending in this application.
6. Claims 5-13 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim.
7. Claims 1-4 are under examination.
Priority
8. The application is a CIP of PCT/KR2021/014261 filed on 10/14/2021, which claims foreign priority to REPUBLIC OF KOREA application No. 10-2020-0138075 filed on 10/23/2020. Even though a certificated copy of the REPUBLIC OF KOREA application is provided, Applicant fails to provide an English-translated copy of the REPUBLIC OF KOREA application with a statement that the translation of the certified copy is accurate. Therefore, the filing date of the priority document has not been perfected. And based on the machine translation of PCT/KR2021/014261, PCT/KR2021/014261 provides support to instant claims 1-4. Therefore, the effective filing date of instant claims 1-4 is 10/14/2021.
Elections/Restrictions
9. Applicant’s election without traverse of Group 1 (claims 1-4) and election of (a) N-terminal in claim 1 and (b) SEQ ID NO: 3 in claim 3 as species of ferritin nanocage in the reply filed on 11/25/2025 is acknowledged. Since the elected species of ferritin nanocage is not a species, the Examiner telephoned Applicant’s representative, Hyun Yong Lee, on 12/9/2025 for further species election. And Applicant’s representative elected on the phone that the ferritin nanocage formed by PpNF disclosed in instant Figure 1 as the elected species of ferritin nanocage. The requirement is made FINAL in this office action.
Group 1 is drawn to a ferritin nanocage comprising a fusion polypeptide, wherein the fusion polypeptide is a PD-L1-binding peptide having an amino acid sequence represented by SEQ ID NO: 2 conjugated to a C-terminal or N-terminal of a human ferritin heavy chain fragment having an amino acid sequence represented by SEQ ID NO: 1. A search was conducted on the elected species; and prior art was found. Claims 1-4 are examined on the merits in this office action.
Claim Interpretations
10. With regards to the term “having an amino acid sequence” recited in instant claims 1 and 3, in the instant case, in view of the disclosure of instant specification and in the broadest reasonable interpretation, the Examiner is interpreting the term “having an amino acid sequence” as “comprising the amino acid sequence”. Such interpretation applies to all the rejections set forth below.
Objections
11. The specification is objected to for the following minor informality: The specification recites “SEQ ID NO: 3 (GG)” on page 7, line 13 of instant specification. Based on the sequence listing filed on 8/14/2023, Applicant is suggested to amend this recitation as “GG”.
Please note: the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification (see MPEP § 608.01).
12. The drawings are objected to for the following minor informality:
Figures 1-13: The quality of these figures are extremely poor. Applicant is required to provide clear images of these figures.
Figures 5, 7 and 8: Each of these figures contains multiple figures. For example, Figure 5 contains 5A-5D; and each of Figures 5A-5D needs its individual description of the drawings. This also applies to Figures 7 and 8.
Figures 10 and 11 are described with respect to color. Reference to specific colors in the description of the drawings should be removed.
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.
13. Claim 1 is objected to for the following minor informality: Claim 1 contains the acronym “PD-L1”. An acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, for example, programmed death-ligand 1 (PD-L1). The abbreviation can be used thereafter.
Furthermore, Applicant is suggested to amend claim 1 as “A ferritin nanocage comprising a fusion polypeptide, wherein the fusion polypeptide is a programmed death-ligand 1 (PD-L1)-binding peptide comprising the amino acid sequence of SEQ ID NO: 2 conjugated to either C-terminus or N-terminus of a human ferritin heavy chain fragment comprising the amino acid sequence of SEQ ID NO: 1”.
14. Claim 3 is objected to for the following minor informality: Applicant is suggested to amend claim 3 as "…wherein the linker comprises the amino acid sequence GG or SEQ ID NO: 4”. In the instant case, based on the disclosure of instant specification, the recited SEQ ID NO: 3 should be GG.
15. Claim 4 is objected to for the following minor informality: Applicant is suggested to amend claim 4 as "…wherein the ferritin nanocage is decorated with the PD-L1-binding peptide on its surface”.
Rejections
Claim Rejections - 35 U.S.C. § 102(a)(1)
16. 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.
17. Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jeon et al (Biomaterials, 2021, 270, pages 1-15, available online on 1/22/2021), and as evidenced by the ferritin heavy chain [Homo sapiens] document (2025, from https://www.ncbi.nlm.nih.gov/protein/NP_002023.2?report=genbank&log$=prottop&blast_rank=3&RID=KKBA9RXC014, enclosed pages 1-3).
The instant claims 1-4 are drawn to a ferritin nanocage comprising a fusion polypeptide, wherein the fusion polypeptide is a PD-L1-binding peptide having an amino acid sequence represented by SEQ ID NO: 2 conjugated to a C-terminal or N-terminal of a human ferritin heavy chain fragment having an amino acid sequence represented by SEQ ID NO: 1.
Jeon et al, throughout the literature, teach a ferritin nanocage PpNF formed by self-assembly of a fusion protein consisting of a PD-L1-binding peptide, GG as a linker, and a short ferritin heavy chain (sFTH, 1–161) in the N- to C-terminus direction; wherein the PD-L1-binding peptide consisting of the amino acid sequence CLQKTPKQC (identical to the PD-L1-binding peptide of instant SEQ ID NO: 2); and wherein the PD-L1-binding peptide is on the outer surface of the a ferritin nanocage, for example, Abstract; page 2, Section “2.1. Generation of PD-L1pep1-ferritin nanocage”; and page 5, Figure 1. And as evidenced by the ferritin heavy chain [Homo sapiens] document, the short ferritin heavy chain (sFTH, 1–161) in the ferritin nanocage PpNF in Jeon et al consists of the amino acid sequence of instant SEQ ID NO: 1 (see for example, the amino acid sequence on page 3). Therefore, the ferritin nanocage PpNF in Jeon et al reads on the ferritin nanocage formed by PpNF disclosed in instant Figure 1 as the elected species of ferritin nanocage; and it meets the limitations of instant claims 1-4.
Since the reference teaches all the limitations of instant claims 1-4; the reference anticipates instant claims 1-4.
Claim Rejections - 35 U.S.C. § 103
18. 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 of this title, 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.
19. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
20. Please note: during the search for the elected species, prior art was found for the non-elected species of ferritin nanocage
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Nam et al (US 2019/0216947 A1) in view of Lee et al (WO 2019117690 A1, filed with IDS, a clear copy of the machine translation is used and enclosed pages 1-42) and Kim et al (US 2018/0291072 A1, filed with IDS).
The instant claims 1-4 are drawn to a ferritin nanocage comprising a fusion polypeptide, wherein the fusion polypeptide is a PD-L1-binding peptide having an amino acid sequence represented by SEQ ID NO: 2 conjugated to a C-terminal or N-terminal of a human ferritin heavy chain fragment having an amino acid sequence represented by SEQ ID NO: 1.
Nam et al, throughout the patent, teach ferritin nanocage formed by self-assembly of a fusion protein comprising a phagocytosis enhancing protein SIRPα or SIRPγ and a ferritin heavy chain protein and a second fusion protein comprising a ferritin heavy chain protein and a single chain-based antibody targeting PD-1/PD-L1 as an immunotherapeutic agent; wherein the single chain-based antibody targeting PD-1/PD-L1 is on the outer surface of the ferritin nanocage; and wherein the SIRPα or SIRPγ is linked to the N-terminal or C-terminal of the ferritin heavy chain protein, for example, Abstract; Figure 1B; page 1, paragraph [0014]; page 9, paragraph [0098]; and claim 18. It meets the limitation of instant claim 4. Nam et al further teach a linker is presented in the fusion proteins, wherein the linker is selected from the group consisting of (G4S)n, (GSSGGS)n and SEQ ID NOS: 65-81, for example, page 4, paragraph [0039]; and page 5, paragraph [0048]. The linkers of (G4S)n, (GSSGGS)n and SEQ ID NOs: 70-72 and 81 in Nam et al comprises the amino acid sequence GG, and meets the limitation of the linker recited in instant claim 3.
The difference between the reference and instant claims 1-4 is that the reference does not teach the PD-L1 binding peptide and the human ferritin heavy chain fragment in the ferritin nanocage recited in instant claims 1-4.
However, Lee et al, throughout the patent, teach a peptide that binds to PD-L1 and its use in cancer immunotherapy; wherein such peptide blocks the interaction between PD-1 and its ligand PD-L1, and in comparison to antibodies that block the PD-1/PD-L1 pathway, it is a highly effective and low-cost inhibitor of PD-1 and PD-L1; and wherein such peptide can be PD-L1Pep-1 consisting of the amino acid sequence CLQKTPKQC (identical to the PD-L1-binding peptide of instant SEQ ID NO: 2), for example, pages 1-2, paragraphs [0001]; [0002] and [0004]; and page 25, paragraph [0085].
Furthermore, Kim et al, throughout the patent, teach a human-derived ferritin monomer fragment and a fusion polypeptide in which a polypeptide or a protein is fused to the N- or a C-terminus of the ferritin monomer fragment optionally via a linker; wherein the human-derived ferritin monomer fragment is short Ferritin H consisting of the amino acid sequence of SEQ ID NO: 2 (identical to the human ferritin heavy chain fragment of instant SEQ ID NO: 1); and wherein in comparison to the wild-type human ferritin heavy chain, the short Ferritin H has various advantages, including a steric hindrance is so alleviated that the limitation on the size of a peptide or a protein that can be fused to the C-terminus is eliminated, for example, Abstract; page 1, paragraphs [0001], [0009] and [0010]; and page 3, paragraphs [0041] and [0047].
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Nam et al, Lee et al and Kim et al to develop a ferritin nanocage comprising a fusion polypeptide, wherein the fusion polypeptide is PD-L1Pep-1 consisting of the amino acid sequence CLQKTPKQC (identical to the PD-L1-binding peptide of instant SEQ ID NO: 2) conjugated to either C-terminal or N-terminal of the short Ferritin H consisting of the amino acid sequence of SEQ ID NO: 2 in Kim et al (identical to the human ferritin heavy chain fragment of instant SEQ ID NO: 1) via a linker comprising the amino acid GG, and wherein the PD-L1Pep-1 is on the outer surface of the ferritin nanocage.
One of ordinary skilled in the art would have been motivated to combine the teachings of Nam et al, Lee et al and Kim et al to develop a ferritin nanocage comprising a fusion polypeptide, wherein the fusion polypeptide is PD-L1Pep-1 consisting of the amino acid sequence CLQKTPKQC (identical to the PD-L1-binding peptide of instant SEQ ID NO: 2) conjugated to either C-terminal or N-terminal of the short Ferritin H consisting of the amino acid sequence of SEQ ID NO: 2 in Kim et al (identical to the human ferritin heavy chain fragment of instant SEQ ID NO: 1) via a linker comprising the amino acid GG, and wherein the PD-L1Pep-1 is on the outer surface of the ferritin nanocage, because Lee et al, throughout the patent, teach a peptide that binds to PD-L1 and its use in cancer immunotherapy; wherein such peptide blocks the interaction between PD-1 and its ligand PD-L1, and in comparison to antibodies that block the PD-1/PD-L1 pathway, it is a highly effective and low-cost inhibitor of PD-1 and PD-L1; and wherein such peptide can be PD-L1Pep-1 consisting of the amino acid sequence CLQKTPKQC (identical to the PD-L1-binding peptide of instant SEQ ID NO: 2). Kim et al, throughout the patent, teach a human-derived ferritin monomer fragment and a fusion polypeptide in which a polypeptide or a protein is fused to the N- or a C-terminus of the ferritin monomer fragment optionally via a linker; wherein the human-derived ferritin monomer fragment is short Ferritin H consisting of the amino acid sequence of SEQ ID NO: 2 (identical to the human ferritin heavy chain fragment of instant SEQ ID NO: 1); and wherein in comparison to the wild-type human ferritin heavy chain, the short Ferritin H has various advantages.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Nam et al, Lee et al and Kim et al to develop a ferritin nanocage comprising a fusion polypeptide, wherein the fusion polypeptide is PD-L1Pep-1 consisting of the amino acid sequence CLQKTPKQC (identical to the PD-L1-binding peptide of instant SEQ ID NO: 2) conjugated to either C-terminal or N-terminal of the short Ferritin H consisting of the amino acid sequence of SEQ ID NO: 2 in Kim et al (identical to the human ferritin heavy chain fragment of instant SEQ ID NO: 1) via a linker comprising the amino acid GG, and wherein the PD-L1Pep-1 is on the outer surface of the ferritin nanocage.
21. Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Nam et al (US 2019/0216947 A1) in view of Lee et al (WO 2019117690 A1, filed with IDS, a clear copy of the machine translation is used and enclosed pages 1-42) and Kim et al (US 2018/0291072 A1, filed with IDS), and further in view of Meyer (EP1884521 A1).
The instant claims 1-4 are drawn to a ferritin nanocage comprising a fusion polypeptide, wherein the fusion polypeptide is a PD-L1-binding peptide having an amino acid sequence represented by SEQ ID NO: 2 conjugated to a C-terminal or N-terminal of a human ferritin heavy chain fragment having an amino acid sequence represented by SEQ ID NO: 1.
The rejection to instant claims 1-4 under 35 U.S.C. 103 as being unpatentable over Nam et al (US 2019/0216947 A1) in view of Lee et al (WO 2019117690 A1, filed with IDS, a clear copy of the machine translation is used and enclosed pages 1-42) and Kim et al (US 2018/0291072 A1, filed with IDS) has been set forth in Section 20 above.
The difference between the rejection set forth in Section 20 above and instant claims 1-4 is that the rejection set forth in Section 20 above does not teach the ferritin nanocage formed by PpNF disclosed in instant Figure 1 as the elected species of ferritin nanocage.
However, Meyer teaches GG as a peptide linker that can be used in fusion protein/polypeptide, for example, page 6, paragraph [0022].
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Nam et al, Lee et al, Kim et al and Meyer to develop a ferritin nanocage comprising a fusion polypeptide, wherein the fusion polypeptide is PD-L1Pep-1 consisting of the amino acid sequence CLQKTPKQC (identical to the PD-L1-binding peptide of instant SEQ ID NO: 2) conjugated to either C-terminal or N-terminal of the short Ferritin H consisting of the amino acid sequence of SEQ ID NO: 2 in Kim et al (identical to the human ferritin heavy chain fragment of instant SEQ ID NO: 1) via a linker comprising the amino acid GG, and wherein the PD-L1Pep-1 is on the outer surface of the ferritin nanocage, including a ferritin nanocage formed by a fusion polypeptide consisting of PD-L1Pep-1, GG as a liker, and the short Ferritin H consisting of the amino acid sequence of SEQ ID NO: 2 in Kim et al in the N- to C-terminal direction, wherein the PD-L1Pep-1 is on the outer surface of the a ferritin nanocage. It reads on the ferritin nanocage formed by PpNF disclosed in instant Figure 1 as the elected species of ferritin nanocage.
One of ordinary skilled in the art would have been motivated to combine the teachings of Nam et al, Lee et al, Kim et al and Meyer to develop a ferritin nanocage comprising a fusion polypeptide, wherein the fusion polypeptide is PD-L1Pep-1 consisting of the amino acid sequence CLQKTPKQC (identical to the PD-L1-binding peptide of instant SEQ ID NO: 2) conjugated to either C-terminal or N-terminal of the short Ferritin H consisting of the amino acid sequence of SEQ ID NO: 2 in Kim et al (identical to the human ferritin heavy chain fragment of instant SEQ ID NO: 1) via a linker comprising the amino acid GG, and wherein the PD-L1Pep-1 is on the outer surface of the ferritin nanocage, including a ferritin nanocage formed by a fusion polypeptide consisting of PD-L1Pep-1, GG as a liker, and the short Ferritin H consisting of the amino acid sequence of SEQ ID NO: 2 in Kim et al in the N- to C-terminal direction, wherein the PD-L1Pep-1 is on the outer surface of the a ferritin nanocage, because Meyer teaches GG as a peptide linker that can be used in fusion protein/polypeptide.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Nam et al, Lee et al, Kim et al and Meyer to develop a ferritin nanocage comprising a fusion polypeptide, wherein the fusion polypeptide is PD-L1Pep-1 consisting of the amino acid sequence CLQKTPKQC (identical to the PD-L1-binding peptide of instant SEQ ID NO: 2) conjugated to either C-terminal or N-terminal of the short Ferritin H consisting of the amino acid sequence of SEQ ID NO: 2 in Kim et al (identical to the human ferritin heavy chain fragment of instant SEQ ID NO: 1) via a linker comprising the amino acid GG, and wherein the PD-L1Pep-1 is on the outer surface of the ferritin nanocage, including a ferritin nanocage formed by a fusion polypeptide consisting of PD-L1Pep-1, GG as a liker, and the short Ferritin H consisting of the amino acid sequence of SEQ ID NO: 2 in Kim et al in the N- to C-terminal direction, wherein the PD-L1Pep-1 is on the outer surface of the a ferritin nanocage.
Obviousness Double Patenting
22. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
23. Claims 1-4 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 of US patent 11306119 B2 in view of Jeon et al (Biomaterials, 2021, 270, pages 1-15, available online on 1/22/2021) and as evidenced by the ferritin heavy chain [Homo sapiens] document (2025, from https://www.ncbi.nlm.nih.gov/protein/NP_002023.2?report=genbank&log$=prottop&blast_rank=3&RID=KKBA9RXC014, enclosed pages 1-3).
24. Instant claims 1-4 are drawn to a ferritin nanocage comprising a fusion polypeptide, wherein the fusion polypeptide is a PD-L1-binding peptide having an amino acid sequence represented by SEQ ID NO: 2 conjugated to a C-terminal or N-terminal of a human ferritin heavy chain fragment having an amino acid sequence represented by SEQ ID NO: 1.
25. Claims 1-8 of US patent 11306119 B2 are drawn to a peptide that specifically binds to PD-L1, consisting of the amino acid sequence of SEQ ID NO: 1 or SEQ ID NO:
2; and methods of using such peptide for diagnosing, preventing or treating cancer .
The PD-L1 binding peptide of SEQ ID NO: 1 recited in claims 1-8 of US patent 11306119 B2 is identical to the PD-L1 binding peptide of instant SEQ ID NO: 2.
26. The difference between claims 1-8 of US patent 11306119 B2 and the ferritin nanocage recited in instant claims 1-4 is that they do not each fusing such PD-L1 binding peptide to a human ferritin heavy chain fragment having an amino acid sequence represented by SEQ ID NO: 1.
However, in view of the teachings of Jeon et al as set forth in Section 17 above, it would have been obvious to one of ordinary skilled in the art to modify the PD-L1 binding peptide of SEQ ID NO: 1 recited in claims 1-8 of US patent 11306119 B2 and develop the ferritin nanocage recited in instant claims 1-4.
27. For the same and/or similar reasonings/rational as the rejection set forth in Sections 23-26 above, instant claims 1-4 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 of US patent 11306119 B2 and in view of the combined teachings of Nam et al (US 2019/0216947 A1), Lee et al (WO 2019117690 A1, filed with IDS, a clear copy of the machine translation is used and enclosed pages 1-42) and Kim et al (US 2018/0291072 A1, filed with IDS) as set forth in Section 20 above.
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658