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 .
DETAILED ACTION
Claims 1-27 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group III,
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and the species of Compound TDH-358, disclosed in paragraph [00442] on pages 108-109 of the instant specification (reproduced below),
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in the reply filed on April 21, 2026 is acknowledged. The requirement is still deemed proper and is therefore made FINAL.
Note to Applicant: The product inventions of Group I and Group III are hereby rejoined. Further, the non-elected inventions of Group IV and Group V have been combined.
Therefore, the revised grouping of inventions is as follows:
Group I, claims 1-5 and 7-22, drawn to products of Chemical Formula 1 and Chemical Formula 2.
Group II, claim 6, drawn to a method for preparing.
Group III, claims 23-27, drawn to a method for treating or preventing a disease.
The invention of revised Group I has been searched and examined based on Applicant’s election of the product invention of original Group III.
Claims 6 and 23-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 21, 2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statements filed on March 27, 2023,
October 11, 2023 and April 30, 2024. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See paragraph [0009] on page 2 of the instant specification.
Specification
The disclosure is objected to because of the following informalities: the labeling of the drawing is not in accordance with 37 CFR 1.84(u)(1),
(u) Numbering of views.
(1) The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.
in that only a single figure has been filed. See paragraph [00285] on page 66 of the instant specification and the single drawing.
Appropriate correction is required.
Claim Objections
Claims 1-5, 8-10, 14-17 and 20 are objected to because of the following informalities:
claims 1-4 and 8-10 are replete with instances wherein the term “unsubstituted” is misspelled (see, for example, the definition of variables R1, R2 and R3 in claim 1; the definition of variables R2 and R3 in claim 2; etc.);
in claim 1, under the definition of R1, “are” should be added after “each” in the phrase “Ra and Rb are the same or different and each independently ...” (see claim 2 for same);
in claim 1, under the definition of R4, “are” should be added after “each” in the phrase “Ra and Rb are the same or different and each independently ...”;
in claim 1, under the definition of R2, “are” should be added after “each” in the phrase “Ra and Rb are the same or different and each independently ...”;
in claim 1, under the definition of R3, “are” should be added after “each” in the phrase “Ra and Rb are the same or different and each independently ...”;
in claim 3, “hydrogen” is listed twice under the definition of the R4 variable;
in claim 5, an “or” should be added before the last compound claimed for proper Markush language format;
in claim 5, a period should be added at the end of the claim;
in claim 14, under the definition of variable R13, an “or” is needed before the last substituent listed for proper Markush language format;
in claim 15, an “or” is needed before the last Chemical Formula 3 structure listed for proper Markush language format;
in claim 15, a period should be added at the end of the claim;
in claim 16, a period should be added at the end of the claim;
in claim 17, an “or” is needed before the last Chemical Formula 5 structure listed for proper Markush language format;
in claim 20, an “or” should be added before the last compound claimed for proper Markush language format; and
in claim 20, a period should be added at the end of the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 and 7-22 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 1 is confusing because of the substituent
“-N-(C1-4alkyl)-” under the definition of variable Z. It is not clear if the “N” or the “C1-4alkyl” in this substituent is connected to the R3 variable substituent. See under the definition of variable Y in claim 1 where it is clear that the nitrogen is attached to the fixed carbonyl in Chemical Formula 1. Further, if Applicant intends for the “C1-4alkyl” to be connected to the R3 variable substituent, then a valence problem would be raised. Therefore, claim 1 is indefinite. Correction is required.
Claim 1 is confusing and therefore indefinite because there are three different definitions for variables Ra and Rb in this independent claim. See the various definitions of the Ra and Rb variables under the definitions of variables R1, R4, R2 and R3 in independent claim 1.
Regarding claim 1, the phrase "(i.e. does not exist)" under the definition of variable B renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). This rejection can be overcome by deleting the phrase "(i.e. does not exist)" from claim 1.
Claim 2 lacks antecedent basis from claim 1 because there is no earlier recitation in claim 1 that any of the R2 substituents can be substituted with “aryl” (see the last line of page 4). See claim 8 for same. Therefore, claims 2 and 8 are indefinite.
Claim 2 is unclear because the substituent, “pididyl”, under the definition of the R3 variable is not known. See claims 3, 4 and 8-10 for same. Claims 2-4 and 8-10 are therefore indefinite because the metes and bounds of the claims cannot be ascertained.
Claim 2 lacks antecedent basis from claim 1 because there is no earlier recitation in claim 1 that the “alkyl” under the definition of the R3 variable can be substituted as stated in claim 2. See claim 8 for same. Therefore, claims 2 and 8 are indefinite.
Regarding claims 4 and 10, the phrases “(preferably, N)” and “(preferably, O)” under the definitions of variables X and Y, respectively, render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). This rejection can be overcome by deleting these phrases from the claims.
Claim 5 lacks antecedent basis from claim 1 because there are compounds being claimed in claim 5 which are not embraced by Chemical Formula 1 in independent claim 1. See, for example, Compound TDH-001, Compound TDH-002, etc. in claim 5. Therefore, claim 5 is indefinite.
Claim 7 lacks antecedent basis from claim 1 because there is no earlier recitation in claim 1 for Chemical Formula 2 as found in claim 7. The “(linker)-E3 Binder” moiety in instant Chemical Formula 2,
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, in claim 7 is not embraced by Chemical Formula 1,
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, in claim 1. See the compounds claimed in claim 20 for same. Therefore, claims 7 and 20 are indefinite.
Regarding claim 7, the phrase "(i.e. does not exist)" under the definition of variable B renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 11, the phrases “preferably” and “more preferably” under the definitions of variables A2, A3, q1, q2 and q3 render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 11 is unclear because the substituent “CC” under the definition of the A3 variable is not known. See claim 18 for same. Claims 11 and 18 are therefore indefinite because the metes and bounds of the claims cannot be ascertained.
Claim 11 lacks antecedent basis from claim 1 and claim 7 because there is no earlier recitation in claim 1 or claim 7 for any of the substituents which define the R1 variable found in claim 11 (see the 3rd-4th lines from the end of the claim). Therefore, claim 11 is indefinite.
Claim 12 lacks antecedent basis from claim 11 because there is no earlier recitation in claim 11 for the linker moieties containing an acetylene (i.e.,
-C≡C-) listed in claims 12 and 19 or that the R1 variable can represent hydroxy. See, for instance, the linker in the 4th row, column 2,
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, of claim 12 as well as the linkers on page 13, column 1, rows 3-4 in claim 12. See claim 19 for same. Therefore, claims 12 and 19 are indefinite.
Claim 14 is unclear because Chemical Formula Y is described as “a compound” (see line 2 of the claim). Therefore, claim 14 is indefinite. This rejection can be overcome by deleting the language “a compound of” from line 2 of claim 14.
Claim 14 lacks antecedent basis from claims 1, 7 and 13 because there is no earlier recitation in claims 1 and 7 for the definition of variable X as found in claim 14. Therefore, claim 14 is indefinite.
Claim 14 lacks antecedent basis from claims 1, 7 and 13 because there is no earlier recitation in claims 1 and 7 for the definition of variable R1 as found in claim 14. Therefore, claim 14 is indefinite.
Claim 14 lacks antecedent basis from claims 7 and 13 because there is no earlier recitation in claims 7 and 13 for the definition of variable n as found in claim 14. Therefore, claim 14 is indefinite.
Claim 14 lacks antecedent basis from claims 1, 7 and 13 because there is no earlier recitation in claims 1, 7 and 13 for the definitions of variables A and B as found in claim 14. Therefore, claim 14 is indefinite.
Claim 14 is unclear because the phrase “disulphide connected to linker or X” under the definition of R9 and R10 is confusing as to its meaning. Therefore, claim 14 is indefinite. Clarification and revision is required.
Claim 16 lacks antecedent basis from claim 14 because there is no earlier recitation in claim 14 that each of Z1, Z2, Z3 or Z4 can represent CH as found in the Chemical Formula 4 structure in claim 16. Therefore, claim 16 is indefinite.
Claim 16 lacks antecedent basis from claim 14 because there is no earlier recitation in claim 14 for the indicated attachment of Chemical Formula 4,
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, in claim 16. Therefore, claim 16 is indefinite.
Regarding claim 18, the phrase “preferably” under the definitions of variables A2 and A3 render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims dependent on independent claim 1 and on any of the dependent claims which do not resolve the problems identified above in claims 1 and in any of the dependent claims are also found indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-5, 7-20 and 22 are rejected under
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 fails to further limit claim 1 because claim 2 is broader in scope than claim 1. Claim 1 does not state that any of the R2 substituents can be substituted with “aryl” as found in claim 2 (see the last line of page 4).
Claims 2 and 8 each fail to further limit claim 1 because claims 2 and 8 are broader in scope than claim 1. Claim 1 does not state that the “alkyl” under the definition of the R3 variable can be substituted as stated in claims 2 and 8.
Claims dependent on dependent claim 2 which do not resolve the problems identified above in claim 2 also suffer failing to further limit claim 1.
Claim 5 fails to further limit claim 1 because claim 5 is broader in scope than claim 1. There are compounds being claimed in claim 5 which are not embraced by Chemical Formula 1 in independent claim 1. See, for example, Compound TDH-067, etc. in claim 5.
Claim 7 fails to further limit claim 1 because claim 7 is broader in scope than claim 1. Compounds embraced by Chemical Formula 2,
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, as claimed in claim 7 are not embraced by the compounds of Chemical Formula 1,
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, as claimed in claim 1. See the compounds claimed in claim 20 for same.
Claims dependent on dependent claim 7 which do not resolve the problems identified above in claim 7 also suffer failing to further limit claim 1.
Claim 11 fails to further limit independent claim 1 and dependent claim 7 because claim 11 is broader in scope than claims 1 and 7. None of the substituents which define the R1 variable found in claim 11 (see the 3rd-4th lines from the end of the claim) are found in the definition of the R1 variable in claim 1 or claim 7.
Claim 12 fails to further limit claim 11 because claim 12 is broader in scope than claim 11. Claim 11 does not state that the linker moieties can contain an acetylene (i.e., -C≡C-) or that the R1 variable can represent hydroxy as found in some of the moieties in claim 12. See, for instance, the linkers in the 5th row, columns 1 and 2 in claim 12 as well as the linkers in rows 3-4 of column 1 on page 13 in claim 12. See claim 19 for same.
Claim 14 fails to further limit the claims from which it depends because claim 14 is broader in scope than the claims from which it depends for several reasons. Firstly, the definition of variable X as found in claim 14 is not stated in claims 1, 7 or 13. Secondly, the definition of variable R1 as found in claim 14 is not stated in claims 1, 7 or 13. Thirdly, the definition of variable n as found in claim 14 is not stated in claims 7 or 13. Fourthly, the definitions of variables A and B as found in claim 14 are not stated in claims 1, 7 or 13.
Claim 16 fails to further limit claim 14 because claim 16 is broader in scope than claim 14. Claim 14 does not state that each of Z1, Z2, Z3 or Z4 can represent CH as found in the Chemical Formula 4 structure in claim 16. Further, claim 14 does not indicate the attachment of Chemical Formula 4,
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, as shown in claim 16.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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, 2 and 21 are rejected under
35 U.S.C. 102(a)(1) as being anticipated by Charrier et al. {U.S. Patent 8,410,112}.
Charrier et al. disclose the compound, 3-amino-6-(4-ethylsulfonylpiperazin-1-yl)-N-phenacyl-pyrazine-2-carboxamide, in sulfuric acid (column 222, lines 1-15 and 63-65),
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{a compound of instant Chemical Formula 1,
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where
X = N;
Y = NH;
Z = a direct bond;
R1 = -A-(B)-R4, where
A = a 6-membered heterocycloalkyl containing more than one N
(i.e., piperazinyl),
B = a direct bond, and
R4 = -SO2Ra and Ra = C2 alkyl (i.e., ethyl);
R2 = hydrogen; and
R3 = aryl, unsubstituted (i.e., phenyl)}.
Further, sulfuric acid is a well-known pharmaceutically acceptable excipient. See pages 719-720 of the Handbook of Pharmaceutical Excipients {Rowe, Raymond C, Paul J. Sheskey, and Marian E Quinn. Handbook of Pharmaceutical Excipients. London: Pharmaceutical Press, 6th Edition, 2009}. Therefore, Charrier et al. anticipates the instant claimed invention.
Allowable Subject Matter
The elected species of Compound TDH-358, disclosed in paragraph [00442] on pages 108-109 of the instant specification, is free of the prior art of record.
Reminder to Applicant
As a reminder, Applicant should specifically point out the support in the original disclosure {i.e., page number(s) and line number(s)} for any new claims or amended claims and for any amendments made to the disclosure. Making generic statements such as “all amendments are fully supported in the originally filed disclosure or the originally filed claims” without specifying page numbers and originally filed claim numbers are insufficient. See MPEP §714.02 and MPEP §2163.06(I).
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Laura L. Stockton
(571) 272-0710.
The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s acting supervisor,
James Alstrum-Acevedo can be reached on 571/272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620
Technology Center 1600
June 12, 2026
Book XXIX, page 61
Prosecution Insights