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 .
Response to Amendment
The amendments received 01/06/2026 have been entered. Claims 1-17 and 19-27 are pending. Any objection or rejection set forth in the Office Action mailed 10/17/2025 not maintained herein has been overcome and is withdrawn. New grounds of rejection have been set forth as necessitated by amendment.
Information Disclosure Statement
The Information Disclosure Statement filed on 10/14/2025 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of list of references cited from the IDS is included with this Office Action.
Claim Objections
Claims 1-5, 8-14, 17, 19-27 objected to because of the following informalities:
Claims 1-5, 8-14, 17, 19, 22-27: "cross-linked PBD dimer conjugate to a cell-binding molecule" should read "cross-linked PBD dimer conjugated to a cell-binding molecule";
Claims 1, 4, 6: “wherein wavy line” should read “wherein a wavy line” and “wavy line is” should read “a wavy line is”;
Claims 1 and 4: “one to 12 amino acid units” should read “1 to 12 amino acid units”;
Claim 2: “Formula (Ia), (Ib), (Ic), or (Ie)” should read “Formula (Ia), (Ib), (Ic), (Id), or (Ie)”;
Claim 6: “tanother pharmaceutically acceptable salt” should read “another pharmaceutically acceptable salt”;
Claims 8, 26: “one of formulae” should read “one of the formulae” or “a formula”;
Claim 8: formula 96 is missing an open bracket “[“;
Claim 10: variables within the claimed structures are inconsistently formatted (e.g., “R7” vs “R7”)
Claim 11: “dimeric and multimeric cyclic RGD peptides Chondroitin sulfate proteoglycan NG2 receptor ligands” should read “dimeric and multimeric cyclic RGD peptides, Chondroitin sulfate proteoglycan NG2 receptor ligands”;
Claims 11, 19, and 20 contain trademark names that have not yet been amended from the claims;
Claim 13: “none-small cell lung cancer cells” should read “non-small cell lung cancer cells”;
Claim 19: “a… (PARP) inhibitors” should read “a… (PARP) inhibitor”;
Claim 19: “an anti-infectious disease agents” should read “an anti-infectious disease agent”;
Claim 20: “everolimus” is listed twice;
Claims 22, 23, and 24: “arylene” is listed twice;
Claim 25: “one of following” should read “one of the following”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-17 and 19-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 4, and 6 recite “L1, and L2 are independently a releasable linker, or a linker which has a functional group on the linker than enables reaction with a cell-binding agent (CBA).” The preamble of claim 1 states, “cell-binding molecule”. Are the cell-binding agent and the cell-binding molecule the same?
Claims 1, 4, and 6 recite “r is independently an integer ranging from 0 to 100”. However, r is also defined as “1-12” amino acid units. This causes confusion as multiple definitions of “r” are set forth.
Claims 1, 4, and 6 recite “t is 0, or 1-100”. However, t is also defined as “1-100 amino acid units”. This causes confusion as multiple definitions of t are set forth.
Claims 1, 4, and 6 recite “Z and Z’ link together to form -COR5OC-“ but both Z and Z’ are defined to contain R55 rather than R5.
Claims 1, 4, and 6 recite “the Stretcher unit W optionally independently contain…” (emphasis added). However, if this limitation is not true, what is W? The term “Stretcher unit” confers no structural meaning in and of itself (nor does “self-immolative spacer”). Clarification is required.
Claims 1, 4, and 6 recite “a linker”. However, the term “linker” does not convey any particular structure and could describe thousands of moieties that one could not possibly envisage. Clarification is required.
Claims 1, 4, and 6 recite alternatives for L1 and L2 that are divalent while both claims recite a genus wherein L1 and L2 must necessarily be trivalent or wherein L1 and L2 are optionally linked by a double bond and are bound to U/U’.
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Claims 1, 4, and 6 recite “R5, R5’, and R5’’… or a pharmaceutical salt”. A pharmaceutical salt is an ionic compound with a neutral charge. It is unclear how a pharmaceutical salt can be a substituent.
Claims 1, 4, and 6 “or U, U’… independently comprise one or more following components”. A Markush grouping should be a closed list of alternatives (i.e., “consisting of” rather than “comprising”). This term “comprising” is indefinite because it is unclear what other alternatives are included.
Claims 6-7, 11-12, 19-20 are replete with instances of a listed alternative being set forth along with a second definition in parenthesis. In some instances, the definitions in the parenthesis seem to set forth shortened term by which the alternative listed before the parenthesis is known (such as “toluenesulfonyl (tosyl)” in claim 6). In other instances, the definitions in the parenthesis are broader or narrower in scope than the alternative listed before the parenthesis. It is unclear, in every instance of a second definition being set forth in parenthesis, whether each alternative is limited to what is set forth in the parenthesis, especially when the scope is either narrower or broader. Clarification is required.
Claim 7 sets forth the structure for formula (V-05) which is not within the scope of claim 6 because it contains a triple bond between L1 and L2. See also dependent claim 9.
Claim 9 depicts “Ph1” and “Ph2” but does not define either variable. Given that they are numbered, it is unclear whether Ph is supposed to mean “phenyl” as is typically understood in the art.
Claims 3, 5 and 7-9 define r as 0-200. This limitation lacks antecedent basis as r is either 1-12 or 0-100 as in claim 1.
Claim 10 recites “of Formula (I), (Ia), (Ib), (Ic), (Ie): (III), (II), (III), or (IV)”. Claim 10 depends on claim 1 wherein formulas (Ia), (Ib), (Ic), (Ie), (III), (II), or (IV) are not recited. Claim 10 therefore lacks antecedent basis.
Claim 10 recites “independently comprise:”. A Markush list of alternatives must be closed (“consisting of” or “selected from the group consisting of” or “is”). It is unclear what other alternative limitations are encompassed by the claim.
Claim 10 recites the term “includes”. A Markush list of alternatives must be closed (“consisting of” or “selected from the group consisting of” or “is”). It is unclear what other alternative limitations are encompassed by the claim.
Claim 10 recites “or a pharmaceutical salt”. A pharmaceutical salt is an ionic compound with a neutral charge. It is unclear how L can be a pharmaceutical salt.
Claim 10 recites “wherein p is an integer from 0 to about 5000”. Claim 1, from which claim 10 depends, recites “p and p’ are independently an integer selected from 0 to about 1000”. Claim 10 lacks antecedent basis.
Claim 10 recites “compounds that are electronically similar to the para-aminobenzyl-carbamoyl… groups”. It is unclear to what degree the compounds must be “electronically similar” to fall within the scope of the claims.
Claim 11 recites “the PBD dimer derivative”. This limitation lacks antecedent basis.
Claims 11 and 19 have been amended such that “analog” and “derivative” have been replaced with “compound” or “compounds”. The specification, on page 18, defines “compound” to “include compounds for which a structure or formula or any derivative thereof has been disclosed in the present invention or a structure or formula or any derivative thereof that has been incorporated by reference. The term also includes, stereoisomers, geometric isomers, tautomers, solvates, metabolites, salts (e.g., pharmaceutically acceptable salts) and prodrugs, and prodrug salts of a compound of all the formulae disclosed in the present invention. The term also includes any solvates, hydrates, and polymorphs of any of the foregoing”. The definition for the term “compound” is an open definition and, besides explicitly including derivatives, solvates, metabolites, prodrugs, etc., would be reasonably interpreted to include other forms such as analogs. These terms are indefinite because they do not have a defined structure known in the art. One could not ascertain as to which analogs and derivatives are within the scope of the claim, nor would one be apprised to the degree of which a compound may differ from its parent structure (e.g., folate) to be considered a “derivative”, “analog”, prodrug, etc., resulting in millions of combinations. One could not possibly envisage all the possibilities of a “compound” of the instant invention.
Claim 19 recites “including” and “comprising” in multiple instances. A Markush grouping should be a closed list of alternatives. These terms are indefinite because it is unclear what other alternatives are included.
Claims 22-25 and 27 recite structures containing R7 and R8, however, definitions are only provided for R7 and R8. The scope of R7 and R8 is unclear. Correction is required.
Claims 22 and 23 set forth alternatives for E1 and E2 that are not within the scope of claim 1:
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and
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, respectively.
Claim 24 recites “wherein L1 and L2 independently comprise”. A Markush group should be a closed list of alternatives. These term “comprising” is indefinite because it is unclear what other alternatives are included.
Claim 26 recites “wherein r, r1, r2, and r’ are independently 0-200”, however, the structures depicted in claim 26 do not contain r1 or r1. Additionally, the definitions of r and r2 are not within the scope of claim 4, wherein r has two definitions of 1-12 or 0-100.
Claim 27 recites alternatives for L1-E1-Q-E2-L2 that are not within the scope of claim 1 because they lack a cross-linker such that one of L1-E1 or E2-L2 are absent. Per claim 1, L1 and L2 cannot be absent as at least a single bond must be shared between them.
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Claim Rejections - 35 USC § 112(a)
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.
Claims 1-17 and 19-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for U, U’, L1, L2, E1, E2 as depicted in Formulas (I-01)-(I-20) of claim 3, does not reasonably provide enablement for cross-linked PBD dimer derivatives or conjugates to a cell-binding molecule of Formulas (I)-(VIII) generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation. (United States v. Teletronics Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is needed is not based on a single factor, but rather a conclusion reached by weighing many factors (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
These factors include the following:
1) Amount of guidance provided by applicant. Applicant has demonstrated within the application how to make compounds of Formula (I)-(VIII). However, the instant specification provides no species wherein U, U’, L1, L2, E1, E2 are beyond the scope of the subgenuses as depicted in Formulas (I-01)-(I-20).
No working examples exist of any compounds with differing connectivity from that above, or any other substituents or groups as previously mentioned. As was stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190 “The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity. However...there is no evidence that such compounds exist...the examples of the '881 patent do not produce the postulated compounds...there is...no evidence that such compounds even exist.” The same circumstance appears to be true here. Hence, Applicants must show that these compounds can be made, or limit the claims accordingly.
2) The nature of the invention and predictability in the art. The invention is directed toward cross-linked PBD dimer derivatives that are conjugated to cell-binding molecules such as antibodies. Regarding predictability in the art, chemistry is generally regarded as unpredictable. See In Re Marzocchi and Horton, 169 USPQ at 367 paragraph 3:
“Most non-chemists would probably be horrified if they were to learn how
many attempted syntheses fail, and how inefficient research chemists are.
The ratio of successful to unsuccessful chemical experiments in a normal
research laboratory is far below unity, and synthetic research chemists, in
the same way as most scientists, spend most of their time working out
what went wrong, and why. Despite the many pitfalls lurking in organic
synthesis, most organic chemistry textbooks and research articles do give
the impression that organic reactions just proceed smoothly and that the
total synthesis of complex natural products, for instance, is maybe a labor-
intensive but otherwise undemanding task. In fact, most syntheses of
structurally complex natural products are the result of several years of
hard work by a team of chemists, with almost every step requiring careful
optimization. The final synthesis usually looks quite different from that
originally planned, because of unexpected difficulties encountered in the initially chosen synthetic sequence. Only the seasoned practitioner who
has experienced for himself the many failures and frustrations which the
development (sometimes even the repetition) of a synthesis usually
implies will be able to appraise such work ......Chemists tend not to publish
negative results, because these are, as opposed to positive results, never
definite (and far too copious)...” Dorwald F. A. Side Reactions in Organic
Synthesis, 2005, Wiley: VCH, Weinheim pg. IX of Preface.
The scope of any compounds, compositions, or pharmaceutically acceptable salts where the variables were not those mentioned above are not adequately enabled or defined. Applicants provide no guidance as to how the compounds are made over the entire scope of Q, U, U’, L1, L2, E1, and E2.
3) Number of working examples. The compound core depicted with specific substituents as above represents a narrow subgenus for which Applicant has provided sufficient guidance to make and use; however, this disclosure is not sufficient to allow extrapolation of the limited examples to enable the scope of the compounds instantly claimed. Applicant has provided no working examples of any compounds, compositions, or pharmaceutically acceptable salts where the variables were not those mentioned above.
Within the specification, “specific operative embodiments or examples of the invention must be set forth, Examples and description should be of sufficient scope as to justify the scope of the claims, Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p).
4) Scope of the claims. The scope of the claims is all of the millions of possible compounds represented by general Formula (I)-(VIII). For example, Formula (I) is depicted below.
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Given the varying modifications for each variable, and especially Q, U, U’, L1, L2, E1, and E2 the claims are incredibly broad. For example, the definitions of L1 and L2 are functional in nature (e.g., “Stretcher unit”, “self-immolative spacer”) for which Applicant has not sufficiently described the scope of these components or how one could envisage them connecting within the core structure of Formula (I).
5) Level of skill in the art. The artisan using Applicant’s invention would be a chemist with a Ph.D. degree and having several years of bench experience.
6) Undue experimentation. MPEP §2164.01 (a) states, "A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)."
The conclusion is clearly justified here that Applicant is not enabled for making these compounds or compositions.
Claim 19 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for salts, optical isomers/enantiomers, racemates, and diastereomers, does not reasonably provide enablement for hydrates, hydrated salts, or polymorphic crystalline structures of Formula (I). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Claim 19 is directed toward hydrates and hydrated salts of the recited compounds. However, the examples provided in the instant application fail to produce any hydrates or hydrated salts. Hydrates, hydrated salts, and polymorphs cannot simply be willed into existence and are incredibly unpredictable. As was stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190 “The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity.” Hence, applicants must show that hydrates and hydrated salts can be made, or limit the claims accordingly.
Claims 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the particular species of chemotherapeutic agents listed in claim 19 or the particular species of synergistic agents as listed in claim 20 (set forth in the claims filed 07/11/2025), does not reasonably provide enablement for chemotherapeutic agents, radiation therapy agents, immunotherapy agents, autoimmune disorder agents, anti-infectious agents or conjugates for synergistically treating or preventing cancer generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The claims are drawn to pharmaceutical compositions comprising a cross-linked PBD dimer derivative or conjugate of Formula (I) and an additional agent (chemotherapeutic agents, radiation therapy agents, immunotherapy agents, autoimmune disorder agents, anti-infectious agents or conjugates for synergistically treating or preventing cancer). Applicant has amended claim 20 to more broadly recite “glycopeptides”, “glycylcyclines”, “macrolides”, etc. The claims are therefore incredibly broad and the specification does not define that which is intended in the use of these agents. There are thousands of chemotherapeutic agents, radiation therapy agents, immunotherapy agents, autoimmune disorder agents, anti-infectious agents or conjugates for synergistically treating cancer in the art which art not supported or contemplated by the instant invention, such that one of ordinary skill in the art would not be apprised as to whether these agents could be combined with the instantly claimed PBD dimer derivative of Formula (I) without undue experimentation.
Claims 1-17 and 19-27 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.
Claims 1, 4, and 6 have been amended to recite the following variables: R55, R55’, R33, R33’, pp, and pp’. These variables were not present in the instant disclosure at the time of filing and are therefore considered new matter. Correction is required. Claims 2-3, 5, 7-17, and 19-27 require the limitations at issue and are also rejected.
Claims 4-5 and 26 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.
Claim 4 discloses compounds containing the variable E3 wherein E3 is divalent. Claim 4 further defines E3 as having one of the following structures.
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There is no support in the instant disclosure for E3 being the above moieties. Moreover, the only alternatives for E3 disclosed at the time of filing are monovalent. These limitations are therefore considered new matter. Correction is required. Claims 5 and 26 require the limitations at issue and are also rejected.
Claim 10 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 10 has been amended to recite that Z1 is NR1, O, S, or CR1. These alternatives are not supported by the instant disclosure, wherein Z1 is always defined as being monovalent
Claims 22 and 23 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.
Claims 22 and 23 set forth alternatives for E1 and E2:
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, respectively. These moieties were not disclosed as alternatives for E1 and E2 at the time of filing, and can only be found within definitions for L1 and L2, but there is no suggestion that the same structures were considered to be within the scope of E1 and E2. These limitations therefore constitute as new matter. Correction is required.
Response to Arguments
Applicant's arguments filed 01/06/2026 have been fully considered and are persuasive in part.
Examiner has considered Applicant’s arguments regarding the rejection of 12 and 13 under 35 U.S.C. 112(d) and finds them persuasive. The rejection is withdrawn.
Examiner acknowledges Applicant’s statement of common ownership regarding prior art document WO 2018/185526 A1. The rejection under 35 U.S.C. 102(a)(2) is withdrawn.
Examiner has considered Applicant’s arguments regarding the rejection of claim 10 under 35 U.S.C. 112(b) and the limitation “electronically similar” and does not find Applicant’s argument to be persuasive. In their Remarks (p. 119) Applicant points to the Hammett equation, which uses constants measuring electronic character (sigma) and sensitivity (rho) to correlate biological activity with chemical structure, as well as Quantitative Structure-Activity (QSAR) models. However, despite Applicant pointing to known methods in the art to evaluate and compare the electronic properties of chemical structures, these metrics do establish to what degree a compound must be “electronically similar” to another in order to be determined, by one of ordinary skill in the art, to be electronically similar to “para-aminobenzyl-carbamoyl… groups”. The rejection is maintained.
The remaining rejections that are maintained above were not addressed or argued against by Applicant, nor did Applicant’s amendments to the claims overcome the rejections. While Applicant’s response is considered bona-fide, the rejections are maintained. New rejections set forth above are necessitated by amendment.
No claims are allowed.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.E.B./Examiner, Art Unit 1624 03/06/2026
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624