COMPOUNDS

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 in the reply filed on August 31, 2026 is acknowledged. Specification The title of the disclosure is objected to because the title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. Similarly, the abstract of the disclosure is objected to because the abstract is too short in length (25 words). Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally be limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. 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). Appropriate correction is required. Claim Objections Claim 2 is objected to because it is missing a proper conjunction (such as “and” or “or”). Claim 2 recites a list of chemical compounds without a proper conjunction. Claim recites “selected from” but needs a conjunction before the last compound to clarify the format. Additionally, claim 2 recites two chemical structures, PNG media_image1.png 71 456 media_image1.png Greyscale and PNG media_image2.png 90 457 media_image2.png Greyscale . It is suggested that the structural difference between the two chemical structures be clarified. Appropriate correction is required. Claim Rejections - 35 USC § 103 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. Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Vinet et al. (WO 2019 030024; cited on IDS filed September 9, 2024) in view of Gadaleta et al. (Critical reviews in oncology/hematology, 2011; cited on PTO-892). Regarding claims 1-4, Vinet discloses an iodinated contrast agent made of fatty acid derivatives for noninvasive visualization and quantification analyses (abstract). Vinet discloses the iodinated fatty acids having a general formula I PNG media_image3.png 222 298 media_image3.png Greyscale (claim 1). This compound of formula I of Vinet reads on a compound of instant claims such as the structure PNG media_image4.png 95 705 media_image4.png Greyscale in instant claim 4, when R2 is an ethyl group, n is 16, two R1 groups are I (which are neither geminal nor vicinal) and the remaining R1 groups are H. Regarding claims 5-8, the claims are product-by-process claims. The patentability of a product-by-process claim is determined based on the product itself and does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable. As discussed above, the compound of Vinet reads on the compound of the instant claims. Because Vinet discloses the same product, the process limitations of claims 5-8 do not confer patentable weight. Therefore, claims 5-8 are unpatentable as the product lacks a structural difference over the prior art. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See MPEP § 2113. Regarding claim 9, Vinet discloses a composition comprising the iodinated fatty acid compound (parge 28, ¶ 4). Regarding claim 10, Vinet discloses a purification of the compound (page 31, ¶ 3). It can be expected that the composition comprises the purified compound. Regarding claim 11, Vinet discloses that a contrast agent can comprise at least two iodinated fatty acids having different carbon chains (page 15, ¶ 3). It can be expected that the composition comprises at least two different compounds. Regarding claims 12-14, Vinet discloses that the iodinated fatty acid can contain a maximum number of iodine atoms as a consequence of hydroiodination reaction of fatty acid alkene double bonds (page 9, ¶ 3). Vinet discloses that the iodinated fatty acids can be preferred periodinated, meaning having the maximum possible amount of iodine atoms within the chemical structure (page 9, ¶ 3; page 15, ¶ 4). Because Vinet discloses a composition comprising only fully saturated compounds, the composition comprises a plurality of the compound having no alkene (fully saturated). Consequently, the moles of alkene can be at least 10 times less than the moles of iodine. Further, a person of ordinary skill in the art would have been motivated to optimize the molar ratio of alkene to iodine in the plurality of the compounds according to the specific requirements of the intended application. The ratio is a clearly result-effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal ratio for achieving the desired properties as an effective contrast agent. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP § 2144. Regarding claim 15, Vinet discloses that the compound such as Lipiodol® (ethiodized oil, composed of iodine combined with ethyl esters of fatty acids of poppyseed oil) can be used as a radio-opaque contrast agent (page 2, ¶¶ 2-4). It can be expected that the composition comprising an iodinated fatty acid compound can be used as a radio-opaque contrast composition. Regarding claim 16, Vinet does not disclose that the composition further comprises an active pharmaceutical agent. Gadaleta discloses that a chemotherapeutic agent (active pharmaceutical agent) can be emulsified in an oily medium used as a drug carrier (page 41, column 1, ¶ 1). Gadaleta discloses that an anticancer drug can be mixed with Lipiodol® to prepare an emulsion, and when the emulsified Lipiodol® and drug mixture is injected into a tumor supplying vessels, the anticancer drug is slowly released from Lipiodol® and remains in high concentrations within the tumor for a prolonged period (page 41, column 2, ¶ 1). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Vinet by adding an active pharmaceutical agent to prepare a drug-loaded radiopaque emulsion enabling targeted delivery for the treatment of certain cancers. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Gadaleta teaches that such an iodized fatty acid ester can be used as an efficient drug carrier to form an emulsion incorporating an anticancer drug. Further, a person of ordinary skill in the art would have been motivated to prepare the composition comprising an iodized fatty acid and active pharmaceutical agent emulsion as a theranostic drug delivery platform in order to expand the application of the composition. Accordingly, applying the teachings of Gadaleta to the composition of Vinet constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders claim 16 obvious. Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Babic (WO 2020 165349; cited on IDS filed June 17, 2026) in view of Gadaleta et al. (Critical reviews in oncology/hematology, 2011; cited on PTO-892). Regarding claims 1-4, Babic discloses a computed tomography (CT) contrast agent comprising iodinated fatty acids for noninvasive diagnosis (abstract; claim 1). Babic discloses iodinated fatty acids having a general formula I PNG media_image3.png 222 298 media_image3.png Greyscale (claim 1). This compound of formula I of Babic reads on a compound of instant claims such as the structure PNG media_image4.png 95 705 media_image4.png Greyscale in instant claim 4, when R2 is an ethyl group, n is 16, two R1 groups are I (which are neither geminal nor vicinal) and the remaining R1 groups are H. Regarding claims 5-8, the claims are product-by-process claims. The patentability of a product-by-process claim is determined based on the product itself and does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable. As discussed above, the compound of Babic reads on the compound of the instant claims. Because Babic discloses the same product, the process limitations of claims 5-8 do not confer patentable weight. Therefore, claims 5-8 are unpatentable as the product lacks a structural difference over the prior art. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See MPEP § 2113. Regarding claim 9, Babic discloses a composition comprising the iodinated fatty acid compound (parge 35, ¶ 3). Regarding claim 10, Babic discloses a purification of the compound (page 28, ¶ 4). It can be expected that the composition comprises the purified compound. Regarding claim 11, Babic discloses that a contrast agent can comprise at least two iodinated fatty acids having different carbon chains (page 39, ¶ 6). It can be expected that the composition comprises at least two different compounds. Regarding claims 12-14, Babic discloses that the iodinated fatty acid can contain maximum number of iodine atoms as a consequence of a hydroiodination reaction of fatty acid alkene double bonds (page 16, ¶ 1). Babic discloses that the iodinated fatty acids can be preferred periodinated, meaning having the maximum possible amount of iodine atoms within the chemical structure (page 16, ¶ 1; page 24, ¶ 8). Because Babic discloses a composition comprising only fully saturated compounds, the composition comprises a plurality of the compound having no alkene (fully saturated). Consequently, the moles of alkene can be at least 10 times less than the moles of iodine. Further, a person of ordinary skill in the art would have been motivated to optimize the molar ratio of alkene to iodine in the plurality of the compounds according to the specific requirements of the intended application. The ratio is a clearly result-effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal ratio for achieving the desired properties as an effective contrast agent. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP § 2144. Regarding claim 15, Babic discloses that the compound such as ethiodized oil (composed of iodine combined with ethyl esters of fatty acids of poppyseed oil) can be used as a radio-opaque contrast agent (page 14, ¶ 1). It can be expected that the composition comprising an iodinated fatty acid compound can be used as a radio-opaque contrast composition. Regarding claim 16, Babic does not disclose that the composition further comprises an active pharmaceutical agent. As discussed above, Gadaleta discloses that a chemotherapeutic agent (active pharmaceutical agent) can be emulsified in an oily medium used as a drug carrier (page 41, column 1, ¶ 1). Gadaleta discloses that an anticancer drug van be mixed with Lipiodol® to prepare an emulsion, and when the emulsified Lipiodol® and drug mixture is injected into a tumor supplying vessels, the anticancer drug is slowly released from Lipiodol® and remains in high concentrations within the tumor for a prolonged period (page 41, column 2, ¶ 1). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Babic by adding an active pharmaceutical agent to prepare a drug-loaded radiopaque emulsion enabling targeted delivery for the treatment of certain cancers. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Gadaleta teaches that such an iodized fatty acid ester can be used as an efficient drug carrier to form an emulsion incorporating an anticancer drug. Further, a person of ordinary skill in the art would have been motivated to prepare the composition comprising an iodized fatty acid and pharmaceutical agent emulsion as a theranostic drug delivery platform in order to expand the application of the composition. Accordingly, applying the teachings of Gadaleta to the composition of Babic constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders claim 16 obvious. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET. 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, Michael G 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. 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. /JONG HWAN BAEK/Examiner, Art Unit 1618 /Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618