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 .
Receipt is acknowledged of Applicant’s Arguments filed on 06/26/2025.
Claims 25-27 have been added. Accordingly, claims 1, 3-8, 10-14, 16-17, 19 and 20-27 are pending in this application.
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 25-27 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.
The term “standard dose” in claim 25 is a relative term which renders the claim indefinite. The term “standard dose” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what amounts of the tetrameric gadolinium compound constitutes less than 50% of a standard dose of compound required.
The remaining claims 26 and 27 are rejected for depending upon a rejected claim.
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, 3-8, 10-14, 16, 17, 19 and 20 are rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,478,696.
Although the claims at issue are not identical, they are not patentably distinct from each
other because there is an overlap of the subject matter claimed in the patent and the
instant claimed invention and both sets of claims are directed to same art specific subject
matter.
The present invention is directed to pharmaceutical composition comprising a tetrameric gadolinium compound of structural formula:,
PNG
media_image1.png
368
606
media_image1.png
Greyscale
, wherein the tetrameric gadolinium compounds with relaxivity values in water.
The claims of U.S. Patent No. 12,478,696 are directed to compounds of formula:
PNG
media_image2.png
406
536
media_image2.png
Greyscale
,
which reads on the gadolinium compounds of the instant claims.
The difference between the instant and issued patent claims is in scope only. The indiscriminate selection of "some" among "many" is prima facie obvious, In re Lemin, 141 USPQ814 (C.C.P.A. 1964). The motivation to make the claimed compounds derives from the expectation that structurally similar compounds would possess similar activity (e.g., relaxivity values when dissolved in water). One skilled in art would thus, be motivated to prepare products embraced by the patent to arrive at the instant claimed products with the expectation of obtaining additional beneficial products with required relaxivity values. The instant claimed invention would have been suggested to one skilled in the art and
therefore, the instant claimed invention would have been obvious to one skilled in the art.
Allowable Subject Matter
Claims 21-24 allowed.
Applicant arguments filed on 06/26/2026 have been fully considered but they are not persuasive. Applicants argue that the pending claims are directed to aqueous pharmaceutical compositions containing tetrameric gadolinium compounds with specified relaxivity values, whereas the claims of the '696 patent are directed to specific gadolinium chelate compounds without any relaxivity limitations or pharmaceutical, composition requirements.
Regarding instant claims 1, 3-8, 10-14, 16, 17, 19 and 20, the instant claims recite various properties of the claimed gadolinium compounds (e.g., r1 and r2 relaxivity values.). Note that a chemical composition (e.g., gadolinium compounds) and its properties are inseparable. Thus, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. In the instant case, the aqueous pharmaceutical composition comprising tetrameric gadolinium compounds and tetrameric gadolinium compounds of U.S. Patent No. 12,478,696 has the same structural and chemical components. Therefore, if the prior art teaches the identical chemical structure/composition, the properties applicant discloses and/or claims are necessarily present." This treatment results from In re Spada, which states that, "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). However, the preparation of aqueous pharmaceutical compositions having various amounts of the active (tetrameric gadolinium compounds) to obtain compositions having the specific relaxivity properties as recited in the instant claims is within the level of skill of one having ordinary skill in the art at the time of the invention. Thus, the claims of the U.S. Patent No. 12,478,696 are not patentably distinct over the instantly claimed subject matter and are properly included in the rejection. Therefore, the ODP rejection is maintained of record.
Conclusion
No claims are allowed at this time.
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 JAGADISHWAR RAO SAMALA whose telephone number is (571)272-9525. The examiner can normally be reached Monday-Friday 9am-6pm.
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, Hartley G Michael 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.
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.
/J.R.S/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
Prosecution Insights