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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-10 and 18, in the reply filed on 2026 May 29 is acknowledged. A search of claims 1-10 and 18 has been extended to the scope of ligands in general or a ligand with a 1,4,7,10-tatraazacyclododecane ring.
Claims 11-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2026 May 29.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2023 September 14 and 2025 March 14 were submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner.
Specification
The abstract of the disclosure is objected to because it is two paragraphs. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-10 and 18 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to lack of written description.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him.
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. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, claims 1-10 and 18 are drawn to a process of preparing a compound composed of two portions prepared by click chemistry and purification by liquid chromatography using an eluent containing a water-soluble organic acid that is liquid under 1 atm and 20°C and contains not trifluoroacetic acid.
(1) Level of skill and knowledge in the art:
GERMEROTH (Organic and Biomolecular Chemistry, 2013¸ 11, 7700-7704) describes a process of preparing a conjugated DOTA in which trifluoroacetic acid is part of the C18 column eluent.
PNG
media_image1.png
480
392
media_image1.png
Greyscale
PNG
media_image2.png
150
396
media_image2.png
Greyscale
(2) Partial structure:
Applicants discuss the following ideas: ligands that can react with a second compound (page 8, paragraph [0032] to page 12, paragraph [0044]); organic acids that can be used in the liquid chromatography eluent (specification, page 5, paragraph [0019] and page 6, paragraphs [0022] and [0023]); a first compound (specification, pages 13-14, paragraph [0053]).
(3) Physical and/or chemical properties and (4) Functional characteristics:
The purifying step of examples 1-4 does uses 0.1% volume acetic acid (specification, page 26, paragraph [0093] to page 27, paragraph [0097]).
(5) Method of making the claimed invention:
Examples 1-5 each describe one embodiment of the process of claim 1 (specification, page 26, paragraph [0093] to page 28, paragraph [0102])
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 that claim(s) 1-10 is/are broad and generic, with respect to at least one limitation recited by claims 1-10 and 18. The possible variations are limitless to any process of reacting a ligand with another compound to produce a new compound which is purified with liquid chromatography eluent system not containing trifluoroacetic acid. Although 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 those compounds specifically disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus. While having written description of a process embodied by claims 1-10 and 18 and compounds identified in the specification tables and/or examples, the specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims.
The description requirement of the patent statue 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.
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 1-10 and 18 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.
In claim 1 the metes and bounds of a first and second compound are not recited. Without clear metes and bounds of a compound reacting with a ligand, the final product of a process of claim does not have clear metes and bounds. The final product of claim 1 relies on both a ligand and a reactant.
The metes and bounds of a water soluble organic acid that is liquid under 1 atm and 20°C are unclear. Although applicants recites formic acid, acetic, and propionic acid in the specification (page 5, paragraph [0019] and page 6, paragraphs [0022] and [0023]), these acids do not limit the claimed process.
In claim 7, the term derivative is unclear. Applicants do not provide guidance in the claims or the specification with regard to how one of the ligands recited in claim 7 can be modified and be considered a derivative.
Claims 7 and 10 recites limitations for a ligand compound. There is insufficient antecedent basis for this limitation in these claims due to claim1 not reciting the structural metes and bounds of a ligand.
Conclusion
Claims 1-10 and 18 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: Germeroth (Organic and Biomolecular Chemistry, 2013¸ 11, 7700-7704) describes a process of preparing a conjugated DOTA in which trifluoroacetic acid is part of the C18 column eluent. This process does not anticipate or render obvious a process of claim 1 because TFA is used.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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 supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. 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.
/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
Prosecution Insights