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 .
Receipt is acknowledged of Applicant’s Restriction Requirement Response and Amendment filed on 02/02/2026; and IDS filed on 01/07/2026, 08/28/2025, 02/04/2025, 11/26/2024, 06/27/2024, and 08/19/2022.
Claims 5-11 have been amended.
Claims 1-14 are pending in the instant application.
Claims 12-14 are withdrawn from further consideration.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-11) in the reply filed on 02/02/2026 is acknowledged.
Double Patenting
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,419,953. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent recites A lanthanide series contrast agent comprising: an aqueous solution having a plurality of lanthanide macrocyclic chelate molecules dispersed therein, and meglumine; wherein the lanthanide macrocyclic chelate molecules comprise metastable chelated molecules and fully chelated molecules, and wherein the number of said metastable chelated molecules is less than 10 molecules per million of said fully chelated molecules (see claim 1), herein the macrocyclic chelate molecules are DOTA (see claim 6), comprising gadolinium ion (see claim 7), wherein the aqueous solution has Gd3+ ion content that is less than 1 part per million (ppm) (see claim 3).
The patent’s contrast agent would have the same chemical/physical properties, such as free Gd3+ ions and maximally stable complexes when placed in water, because the patent’s contrast agent has the same ingredients as claimed by Applicant, unless proven otherwise.
Claim Rejections - 35 USC § 112, 2nd paragraph
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.
Claim 1 contains the term "Gd-DOTA", which is not defined by the claims. Claims must stand alone to define the invention, and should not rely on the description or the drawings to give them meaning (see Ex Parte Fressola, 27 USPQ 2d 1608). Thus, claim 21 at the very least, should define " Gd-DOTA " by its formal chemical name; once " Gd-DOTA " is defined, the term " Gd-DOTA " may be subsequently recited.
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 (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.
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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DESLAURIERS et al (US 2018/0185521).
Regarding claim 1, DESLAURIERS teaches a contrast agent comprised of: gadolinium-DOTA complexes (see abstract and [0025] at Table 1) and meglumine in aqueous solution (see abstract), wherein the contrast agent forms very stable complexes (see [0022]). The final product form is formulated as an aqueous solution (see [0082]). DESLAURIERS’s contrast agent would have the same chemical/physical properties, such as free Gd3+ ions and maximally stable complexes when placed in water, because DESALURIERS’s contrast agent has the same ingredients as claimed by Applicant, unless proven otherwise.
Note, Applicant’s preamble recitation of “being in an aqueous solution” appears to be an intended use, because Applicant’s contrast agent does not comprise water, but rather recites what happens when the contrast agent is placed in water, such as “at most 100 ppm of free Gd³+ ion, wherein greater than 90% of the Gd-DOTA complexes are maximally stable complexes”.
Regarding claims 2-4, DESLAURIERS further teaches “Free gadolinium metal ion has 8 inner-sphere sites for water, and the complex form has only 1 inner-sphere for water. The Gibbs free energy of the equilibrium process between complex and free metal ion will have large favorable entropy toward the complex form due to the release of seven of the eight inner-spheres for water. This entropy contribution is referred to as the “chelate effect”. This chelate effect can be compromised by the presence of solvent, which can form binding spheres with solvent rather than water” (see [0022]). Thus, the maximal stability would have 1 inner sphere for water and less stable/metastable would have up to 8 sites for water, such as 4 or 5 water molecules.
Regarding claims 5-11, DESAURIERS teaches less than 1 part per million of free Gd(III) ion (see claim10).
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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