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 .
Response to Election/Restriction filed on is acknowledged.
Claims 1-11 and 15-22 are pending in this application.
Priority
4. Applicant claims foreign priority to JP 2009-122096 and JP 2010-071774. The certified copies have been received by the Office. However, English translation have not been provided. Therefore, the foreign priority dates have not been perfected. Thus, the effective filing date of instant application is May 19, 2010 until the foreign priority dates are perfected.
Restriction
5. Applicant’s election of Group 1 (claims 1-9, 11 and 15-20) and the election of the compound 324
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as the species of a fully defined compound of insulin/insulin analog and modifying groups (SEQ ID NO: 1 and SEQ ID NO: 23) in the reply filed on September 9, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 10 and 21-22 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claims. Applicant indicates that claims 1-6, 8-9, 11, 15-18 and 20 read on the elected species. Claims 7 and 19 are withdrawn from further consideration as being drawn to nonelected species. Claims 1-6, 8-9, 11, 15-18 and 20 are examined on the merits in this office action.
Objections
6. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “The present invention relates to novel insulin..” at line 1 of the abstract. Further, at line 3, the abstract recites, "…also relates to novel intermediates...the invention provides a pharmaceutical…" Applicant should correct these informalities. See MPEP 608.01(b). For example, the abstract is recommended to be amended to recite, “Insulin derivatives and their use…are described.”
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. MPEP § 608.01.
7. Claim 1 is objected for the following: Claim 1 recites, “…Formula M6 wherein the
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…” There appears to be an error at page 7 of claim 1. Applicant is required to correct this error.
8. Claim 8 is objected for the following: Claim 8 recites, “A compound according to claim 1…” Claim 8 should be corrected to recite, “The compound according to claim 1…”
9. Claim 20 is objected for the following: Claim 20 recites, “A compound according to claim 2…” Claim 20 should be corrected to recite, “The compound according to claim 2…”
Rejections
U.S.C. 112
10. 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.
11. Claims 1-6, 8, 11, 15-18 and 20 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.
12. Claim 1 recites, “A compound comprising i) human insulin or a human insulin analogue…” It is unclear what compounds/sequences are encompassed within “human insulin analogue”. The instant specification discloses the following: “The term insulin analogue as used herein means a modified human insulin wherein one or more amino acid residues of the insulin have been substituted by other amino acid residues and/or wherein one or more amino acid residues have been deleted from the insulin and/or wherein one or more amino acid residues have been added and/or inserted to the insulin” (see paragraph [0056] of instant US 2022/0184184); “The term insulin analogue as used herein means an insulin analogue displaying insulin activity, i.e., which activates the insulin receptor (see paragraph [0057]); “Examples of insulin analogues include: des B30 human insulin (SEQ ID NO: 1 and SEQ ID NO: 11)…” (see paragraphs [0070]-[0083]). The metes and bounds of the claim is unclear. The claim does not clearly define what compounds are encompassed within “human insulin analogue”. The structure function correlation is not clearly defined. Because claims 2-6, 8, 11, 15-18 and 20 depend from indefinite claim 1 and do not clarify the point of confusion, these claims are also rejected under 35 U.S.C. 112(b).
13. Claim 3 recites the limitation “or a linker L” in claim 3b). There is insufficient antecedent basis for this limitation in the claim. Claim 3 depends from claim 1. Claim 1 does not recite “a linker”. Therefore, there is lack of antecedent basis.
14. Claim 5 recites, “…b) the epsilon amino group of a lysine in position 22 of the A-chain of said human insulin analogue; or…c)…the epsilon amino group of a lysine residue in position 1 or position 4 of the B-chain of said human insulin analogue…” It is unclear if Applicant is only referring to human insulin analogue or if human insulin is also included in the claim recitation. The recites both human insulin and human insulin analogue and just human insulin analogue.
15. Claim 5 recites the limitation "the epsilon amino group of a lysine in the A-chain of said human insulin analogue…the epsilon amino group of the lysine in said optional peptide spacer at the C-terminal of the A-chain of said human insulin or human insulin analogue…the epsilon amino group of a lysine residue in position 1 or position 4 of the B-chain of said human insulin analogue; the epsilon amino group of a lysine in said optional peptide spacer at the N-terminal of the B-chain of said human insulin or human insulin analogue……or the distal amino group marked with *1 in said optional linker L at the N-terminal of the B-chain…the epsilon amino group of a lysine in position 22 or position 29 of the B-chain of said human insulin or human insulin analogue” in claim 1b), 1c) and 1d). There is insufficient antecedent basis for this limitation in the claim. Claim 5 depends from claim 1. Claim 1 does not define the sequences of human insulin and human insulin analogues. The A-chain of human insulin has the sequence: Gly-Ile-Val-Glu-Gln-Cys-Cys-Thr-Ser-Ile-Cys-Ser-Leu-Tyr-Gln-Leu-Glu-Asn-Tyr-Cys-Asn. The B-chain of human insulin has the sequence: Phe-Val-Asn-Gln-His-Leu-Cys-Gly-Ser-His-Leu-Val-Glu-Ala-Leu-Tyr-Leu-Val-Cys-Gly-Glu-Arg-Gly-Phe-Phe-Tyr-Thr-Pro-Lys-Thr. The sequences do not support the residues and “said optional linker L” the claims are referring to. Therefore, there is lack of antecedent basis.
16. Claim 8 recites, “…
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” It is unclear if Applicant is only referring to human insulin analogue or if human insulin is also included in the claim recitation. The recites both human insulin and human insulin analogue and just human insulin analogue.
17. Claim 8 recites the limitation "
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” in claim. There is insufficient antecedent basis for this limitation in the claim. Claim 8 depends from claim 1. Claim 1 does not define the sequences of human insulin and human insulin analogues. The A-chain of human insulin has the sequence: Gly-Ile-Val-Glu-Gln-Cys-Cys-Thr-Ser-Ile-Cys-Ser-Leu-Tyr-Gln-Leu-Glu-Asn-Tyr-Cys-Asn. The B-chain of human insulin has the sequence: Phe-Val-Asn-Gln-His-Leu-Cys-Gly-Ser-His-Leu-Val-Glu-Ala-Leu-Tyr-Leu-Val-Cys-Gly-Glu-Arg-Gly-Phe-Phe-Tyr-Thr-Pro-Lys-Thr. The sequences do not support the residues the claims are referring to. Therefore, there is lack of antecedent basis.
18. Claim 15 recites the limitation “or a linker L” in the claim 15b). There is insufficient antecedent basis for this limitation in the claim. Claim 15 depends from claim 2. Claim 2 does not recite “a linker”. Therefore, there is lack of antecedent basis.
19. Claim 17 recites, “…
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”. It is unclear if Applicant is only referring to human insulin analogue or if human insulin is also included in the claim recitation. The recites both human insulin and human insulin analogue and just human insulin analogue.
20. Claim 17 recites the limitation "
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” in claim. There is insufficient antecedent basis for this limitation in the claim. Claim 17 depends from claim 2. Claim 2 does not define the sequences of human insulin and human insulin analogues. The A-chain of human insulin has the sequence: Gly-Ile-Val-Glu-Gln-Cys-Cys-Thr-Ser-Ile-Cys-Ser-Leu-Tyr-Gln-Leu-Glu-Asn-Tyr-Cys-Asn. The B-chain of human insulin has the sequence: Phe-Val-Asn-Gln-His-Leu-Cys-Gly-Ser-His-Leu-Val-Glu-Ala-Leu-Tyr-Leu-Val-Cys-Gly-Glu-Arg-Gly-Phe-Phe-Tyr-Thr-Pro-Lys-Thr. The sequences do not support the residues and “said optional linker L” the claim is referring to. Therefore, there is lack of antecedent basis.
21. Claim 20 recites, “A compound according to claim 2, comprising…
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”. It is unclear if Applicant is only referring to human insulin analogue or if human insulin is also included in the claim recitation. The recites both human insulin and human insulin analogue and just human insulin analogue.
22. Claim 20 recites the limitation, “
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” in the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 20 depends from claim 2. Claim 2 does not define the sequences of human insulin and human insulin analogues. The A-chain of human insulin has the sequence: Gly-Ile-Val-Glu-Gln-Cys-Cys-Thr-Ser-Ile-Cys-Ser-Leu-Tyr-Gln-Leu-Glu-Asn-Tyr-Cys-Asn. The B-chain of human insulin has the sequence: Phe-Val-Asn-Gln-His-Leu-Cys-Gly-Ser-His-Leu-Val-Glu-Ala-Leu-Tyr-Leu-Val-Cys-Gly-Glu-Arg-Gly-Phe-Phe-Tyr-Thr-Pro-Lys-Thr. The sequences do not support the residues the claims are referring to. Therefore, there is lack of antecedent basis.
Improper Markush
23. Claims 1-6, 8-9, 11, 15-18 and 20 are rejected on the judicially created 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 Hazumi, 3 USPQ 2d 1059, 1060 (BPAI 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: The compounds claimed do not share a common structural feature and a common use. For example, the ISA had indicated that different modifying groups into 6 different categories:
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(see p. 7 of ISA dated 9/24/2021). The linkers claimed comprise different amino acid contents and do not share a common core structure. For example, SEQ ID NO: 39 has the sequence (GES)pK, wherein p is an integer from 3 to 12; SEQ ID NO: 32 has the sequence GKPG. Thus, if p is 3, then SEQ ID NO: 39 has the sequence GESGESGESK. SEQ ID NO: 32 and SEQ ID NO: 39 do not share a common core sequence. Additionally, human insulin analog have different amino acid content. Therefore, these human insulin analogs comprise multiple different sequences involving different amino acid contents.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR 41.31 (a)(1) (emphasis provided).
U.S.C. 112(a)
24. 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.
25. Claims 1-6, 8, 11, 15-18 and 20 are 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.
The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gostelli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, the claims are drawn to a compound comprising i) human insulin or a human insulin analogue…a spacer… The generic statements a human insulin analogue…a spacer do not provide ample written description for the compounds since the claims do not describe a single structural feature. The specification does not clearly define or provide examples of what qualify as compounds of the claimed invention.
As stated earlier, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable claims 1 and 11 are broad generics with respect all possible compounds encompassed by the claims. The possible structural variations are limitless to any class of peptide or a peptide-like molecule that can form amide bonds, and make up the class of human insulin analogs. It must not be forgotten that the MPEP states that if a peptide is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond compounds disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus since the specification does not provide how many amino acids can be substituted, deleted and added to the human insulin sequence without altering the insulin function. The specification is void of organic molecules that functions as a peptide-like molecule that qualify for the functional characteristics claimed as a peptide or a peptide-like molecule or other peptidic molecules, and other synthetic peptide or peptide-like molecule that can function form amide bonds and function as peptides and human insulin analogs.
The specification is limited to the already known human insulin analogs recited in claim 9, for example. The specification discloses the following:
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(see paragraphs [0052]-[0053]). The specification further discloses the following:
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(see paragraphs [0056]-[0058], [0066] and [0071]-[0083]). The working example describes desB30 human insulin analogs
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(see paragraphs [0071]-[0083]). The specification does not describe any other human insulin analogs, or any other human insulin analogs that include peptide-like molecules and other synthetic molecules that functions as peptides. Description of different desB30 human insulin is not sufficient to encompass numerous other proteins and proteases that belong to the same genus. For example, there are varying lengths, varying amino acid compositions, and numerous distinct qualities that make up the genus. Additionally, the unpredictability of the effect of amino acid substitution on the function and/or property of peptide/protein is further confirmed and discussed in Yampolsky et al (Genetics, 2005, 170: 1459-1472). Yampolsky et al teach even conservative substitution can significantly affect the function of the peptide/proteins (see for example, p. 1465, Table 3). Yampolsky et al illustrate the inherent unpredictability with respect to the biological activity of a given peptide/protein after even minor changes to the primary amino acid sequence. There is not sufficient amount of examples provided to encompass the numerous characteristics of the whole genus claimed.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
U.S.C. 102
26. 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.
27. 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.
28. Claim(s) 1, 5-6 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson et al (WO 2014/093696, filed with IDS).
29. Anderson et al teach compounds, composition, and methods for “smart” delivery of a therapeutic agent, such as glucose-mediated deliver of insulin through glucose-sensing insulin derivatives (see abstract). Anderson et al teach insulin derivatives with a built in glucose sensor, such as an aryl boronate moiety (see p. 3, lines 26-27). Anderson et al teach that PBA is a boronic acid containing a phenyl substituent and two hydroxyl groups attached to boron. PBA and its derivatives form complexes with polyol molecules such as glucose and fructose, and can form complexes with polyols and diols (see p. 3, lines 19-22). Anderson et al teach examples of PBAs
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, (see FIG. 1A), meeting the limitation of instant claim 1, formula R1c. Anderson et al teach insulin lysine residue attached to a linker and 3 PBAs having the structure
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(see FIG. 3). Figure 12 of Anderson et al teach bile acid modified insulin series (all attached to B29 lysine of the insulin). Since Anderson et al teach ALL of the active components, Anderson et al meets the limitation of instant claims 1, 5-6 and 11.
30. Claims 1-3, 5-6, 11, 15 and 17-18 are rejected under 35 U.S.C. 102(a)(2) as being unpatentable over Kruse et al (WO 2019/092125, filed with IDS).
31. Kruse et al teach diboron conjugates of general formula I’ , wherein D represents insulin or an insulin analog
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(see pp. 3-7 and throughout the document, especially examples and claims). Kruse et al teach formula IIa and IIb:
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(see page 10), meeting the limitation of instant claims 1-3, 5-6, 15, 17-18. Kruse et al teach pharmaceutical composition comprising the diboron conjugates and one or more excipient (see p. 22), meeting the limitation of instant claim 11. Since Kruse et al teach ALL of the active components, Kruse et al meets the limitation of instant claims 1-3, 5-6, 11, 15 and 17-18.
CONCLUSION
Claim 9 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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/JULIE HA/Primary Examiner, Art Unit 1654
1/14/2026