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 .
Claim Status
Claims 4, 9-13, and 15 were amended and claims 16-17 were newly added in the response filed 2/2/2026. Claims 1-17 are pending and under examination.
Drawings
The drawings filed on 2/2/2026 are acceptable, therefore the objection to the drawings on p. 2-3 of the OA dated 8/1/2025 is withdrawn.
Claim Interpretation
The title compound, “5-acetamido-N,N’-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophathalamide” is not depicted in the disclosure. The compound is interpreted to refer to that having CAS® registry number (RN): 31127-80-7:
PNG
media_image1.png
256
360
media_image1.png
Greyscale
, as evidenced by the SciFinder Entry for RN 31127-80-7, downloaded on 8/14/2025. See “Other Names for this Substance” section.
The relative term “crude”, present throughout the claims, does not appear to have any special definition in the disclosure as filed. Therefore, using BRI, the term is interpreted to refer to any title compound which is subjected to the instantly claimed method.
Claim 15 recites: “Purified 5-acetamido-N,N’-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophathalamide, produced by the method of claim 1, wherein the purified compound has a salt content of ≤0.2 w/w%”. This is a product-by-process claim. Therefore, the method of claim 1 is only considered to the extent that it limits the structure of the claimed compound. See MPEP 2113.
Claim Rejections - 35 USC § 112(b)
The amendments and arguments filed on 2/2/2026 (see p. 7) have been fully considered and are persuasive to overcome the rejections of record on p. 4-6 of the OA dated 8/19/2025; therefore, the rejection is withdrawn.
New Claim Rejections - 35 USC § 112(d)
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 16 and 17 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.
Both claims, newly introduced in the 2/2/2026 response, do not further limit the claims from which they depend. 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
The Applicant amended claim 15 to require “wherein the purified compound has a salt content of ≤0.2 w/w%”. Saanum (US 9688614) does not explicitly teach this limitation, therefore the rejection of record on p. 6-7 of the OA dated 8/19/2025 is withdrawn.
Claim Rejections - 35 USC § 103
Regarding the rejection of record over Saanum (US9688614, published on 6/27/2017) in view of Holmaas (US 7754920, published on 7/13/2020); Cervenka (US 8163965, published on 4/24/2012); Alvarez (“Continuous Plug Flow Crystallization of Pharmaceutical Compounds” Crystal Growth and Design Article, 2010, p. 2219); and Wood (“Progress to Date in the Design and Operation of Continuous Crystallization Processes for Pharmaceutical Applications” Org. Process. Res. Dev. 2019, p. 122) on p. 7-18 of the OA dated 8/19/2025, the Applicant’s arguments on p. 10-14 of the 2/2/2026 response have been fully considered and are persuasive.
The Applicant argues that there is a lack of motivation to combine the cited references to arrive at the claimed process, requiring the specific compound claimed, a continuous plug flow reactor, removal of solvent, and portion wise addition of acid. These arguments are persuasive; therefore, the rejection of record is withdrawn.
The Applicant also argues that the process produces unexpected results because the salt content of the final product is ≤0.2 w.w%. This argument was considered but is not persuasive. As evidenced by the teachings of Askildsen (US 2011/0021822, published on 1/27/2011), the claimed salt levels are known to be achieved from other continuous stepwise crystallizations of the claimed compound. See [0026].
New Claim Rejections - 35 USC § 102/103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 15 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Askildsen (US 2011/0021822, published on 1/27/2011).
Askildsen teaches an example wherein purified 5-acetamido-N,N’-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophathalamide (compound A) is obtained having a salt content of 0.2 – 0.3 wt% NaCl. See [0019-0028].
If the salt content is 0.2 wt%, then the compound anticipates that claimed by explicitly meeting all of the claimed structural limitations. See MPEP 2131.
If the salt content is 0.2 – 0.3wt%, this range overlaps with the claimed salt content range. See MPEP 2144.05. Therefore, it would have been prima facie obvious for the skilled artisan to arrive at compound A having a salt content within the claimed range based on the teachings of Askildsen with a reasonable expectation of success before the effective filing date of the claimed invention because Askildsen exemplifies a compound A which can have the claimed salt concentration at the lower end of the range. Thus, such an embodiment of compound A can be predictably achieved using the teachings of Askildsen. Also see MPEP 2144.05.
Allowable Subject Matter
Claims 1-14 are allowed.
The following is an examiner’s statement of reasons for allowance: the closest prior art to the claimed invention are the references of record. The instantly claimed process is distinguished from the prior art for the reasons set forth above.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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 AMY C BONAPARTE whose telephone number is (571)272-7307. The examiner can normally be reached 11-7.
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, Scarlett Goon can be reached at 571-270-5241. 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.
/AMY C BONAPARTE/ Primary Examiner, Art Unit 1692