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 .
Response to Arguments
Applicant's arguments, filed June 26, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102
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.
Claims 1-6, 10, 12-20, 24, and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Swanson et al. (US 2020 0330619; cited on IDS filed April 5, 2024).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed March 2, 2026 and those set forth herein.
Regarding new limitation of amended claims 1, 13, and 34, “the alcohol and surfactant form a multilamellar structure,” Swanson discloses that lamellar liquid crystal vesicles can be provided by mixing a high-molecular weight alcohol, an ionic surfactant, and water solutions (¶ 5). Swanson discloses that some of the phantom samples have low viscosity and comprise regions of freely diffusing water and water restricted in multilamellar lipid vesicles (¶ 44). Swanson discloses that adjusting the concentrations of the alcohols and/or surfactants provides for tuning the phantoms to provide any clinically relevant kurtosis value and that the surfactant can create increased lamellar spacing in the multilamellar structure (¶ 44).
Applicant argues that Swanson does not disclose each element of the claims as amended because Swanson does not disclose that the composition forms the recited multilamellar structure within the claimed concentration range. Applicant argues that at the concentrations Swanson prepares and characterizes, the compositions form vesicle suspensions rather than the recited multilamellar structure. Applicant argues that the only pH-adjustment disclosure in Swanson (lactic acid) appears in the context of a CA-BTAC2 formulation rather than the elected species.
This argument is unpersuasive. As discussed above, Swanson discloses that the composition can form a multilamellar structure by adjusting the concentration of the alcohols and/or surfactant. As discussed in the Office Action mailed March 2, 2026, Swanson discloses that vesicle-forming components comprising lamellar systems of alcohols and surfactants can be present at a concentration of 20 % by weight (¶ 51; claims 74-76), which reads on the claimed concentration range. At such concentration of alcohol and surfactant, multilamellar structure can be formed as disclosed in the instant specification (page 6, ¶ 5). Forming a multilamellar structure at a high concentration is an inherent result. Identical formulations operating within the same concentration range inherently yield the same physical structures unless Applicant provides objective comparative evidence demonstrating otherwise. Regarding the pH buffer, Swanson discloses that the formulation for CA (cetearyl alcohol)-BTAC (behentrimonium chloride) can comprise CA, CTAB (cetrimonium bromide), and lactic acid, and that the lactic acid can be used as a pH buffer (¶ 82). The CA and CTAB of Swanson read on the elected species.
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 1-6, 10, 12-20, 24, 34, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Swanson et al. (US 2020 0330619; cited on IDS filed April 5, 2024) in view of Cabana et al. (Concepts in Magnetic Resonance Part A, 2015).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed March 2, 2026 and those set forth herein.
As discussed above, regarding new limitation of amended claims 1, 13, and 34, “the alcohol and surfactant form a multilamellar structure,” Swanson discloses that lamellar liquid crystal vesicles provided by mixing a high-molecular weight alcohol, an ionic surfactant, and water solutions (¶ 5). Swanson discloses that some of the phantom samples have low viscosity and comprise regions of freely diffusing water and water restricted in multilamellar lipid vesicles (¶ 44). Swanson discloses that adjusting the concentrations of the alcohols and/or surfactants provides for tuning the phantoms to provide any clinically relevant kurtosis value and that the surfactant can create increased lamellar spacing in the multilamellar structure (¶ 44).
Applicant argues that the combination of Swanson and Cabana does not teach or suggest a composition that forms a multilamellar structure as recited. Applicant argues that the transition from a vesicle suspension to the recited multilamellar structure is not a mere optimization of a result-effective variable but a qualitative, structural change. Applicant argues that there is no sufficient reason to combine Cabana’s magnetization transfer (MT) analysis software with the system of Swanson.
This argument is unpersuasive. As discussed above, Swanson teaches that the composition can form a multilamellar structure. The structural self-assembly into a multilamellar phase is an inherent phenomenon occurring at such concentrations. A POSITA seeking to achieve target MRI properties would naturally tune the concentration as taught by Swanson to form a multilamellar structure in order to adjust diffusion parameters and tune clinically relevant kurtosis values. Further, it is well-known in the art that incorporating a multilamellar structure into MRI phantom materials is highly advantageous for closely mimicking the restricted diffusion and high kurtosis observed in biological tissues as taught by Swanson. Consequently, modifying the formulation to intentionally forms a multilamellar structure in a phantom composition is a matter of obvious design choice and routine optimization to a POSITA seeking to tailor tissue-mimicking characteristics. Further, the concentration of active components in surfactant-alcohol mixture is a recognized result-effective variable known to dictate phase behavior. Merely adjusting concentration within a disclosed range to achieve an expected phase transition does not impart patentability, especially where the physical structure inherently flows form the chosen concentration. Regarding the combination with Cabana’s MT analysis software, as discussed in in the Office Action mailed March 2, 2026, Cabana teaches a software package for simple and easy quantitative MT imaging. It would have been obvious to a POSITA to combine the software package of Cabana with the system of Swanson to efficiently analyze the data for MT imaging and signal processing. A POSITA would be motivated to automate and standardize phantom analysis using readily available analytical tools. In the art of MRI tissue-mimicking phantoms, particularly those employing multilamellar structure, MT and restricted diffusion are intrinsically coupled physical phenomena resulting from the same lipid-bound macromolecular microstructures. Because Swanson’s phantom comprise multilamellar structures containing bound macromolecular components, it inherently possesses MT properties alongside diffusion and kurtosis characteristics. A POSITA evaluating a physical tissue-mimicking phantom such as the multilamellar phantom disclosed by Swanson would naturally seek to fully characterize its MRI properties across multiple clinically relevant contrast mechanisms, including both diffusion/kurtosis and magnetization transfer. Installing or applying Cabana’s software package, which Cabana explicitly teaches for simple, quantitative MT data analysis, onto Swanson’s system represents nothing more than applying a known analytical software tool to evaluate a known physical material capable of MT response, indicating combining known elements to achieve predictable results. Accordingly, a POSITA would have a motivation to combine these two techniques to achieve a multi-parametric validation, and the rejection is maintained.
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 1-6, 10, 12-20, 24, 34, and 35 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 70, 72, 73, and 89 of copending Application No. 19/366,641 in view of Swanson et al. (US 2020 0330619; cited on IDS filed April 5, 2024) and Cabana et al. (Concepts in Magnetic Resonance Part A, 2015).
Applicant requests the Office to hold the rejection in abeyance until the claims in either application are allowable. This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed March 2, 2026 and those set forth herein.
Regarding new limitation of amended claims 1, 13, and 34, “the alcohol and surfactant
form a multilamellar structure,” claims of the ‘641 do not recite the multilamellar structure. As discussed above, Swanson discloses that discloses that lamellar liquid crystal vesicles provided by mixing a high-molecular weight alcohol, an ionic surfactant, and water solutions (¶ 5). Swanson discloses that some of the phantom samples have low viscosity and comprise regions of freely diffusing water and water restricted in multilamellar lipid vesicles (¶ 44). Swanson discloses that adjusting the concentrations of the alcohols and/or surfactants provides for tuning the phantoms to provide any clinically relevant kurtosis value and that the surfactant can create increased lamellar spacing in the multilamellar structure (¶ 44).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to make the composition of the ‘641 form a multilamellar structure for preparing more effective phantoms. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Swanson teaches that multilamellar vesicles can be formed with alcohol and surfactant for an imaging phantom. Further, a person of ordinary skill in the art would have been expected the multilamellar structure to be inherently formed, because claim 1 of the ‘641 recites the same composition with the same w/w concentration of the alcohol and surfactant as that claimed. Identical formulations operating within the same concentration range inherently yield the same physical structures unless Applicant provides objective comparative evidence demonstrating otherwise.
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 JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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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.
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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