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 and species of alcohols with alkane chains comprising 10 to 18 carbons, CTAB (cetyltrimethyl ammonium bromide), pH buffer, and magnetic resonance imaging apparatus is present in the reply filed on January 28, 2026 is acknowledged.
Specification
The disclosure is objected to because of the following informalities:
The use of the term Sephadex® which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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.
Claim(s) 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).
Regarding claim 1, Swanson discloses a diffusion kurtosis imaging (DKI) phantom comprising long-chain alcohols and surfactants in water (claims 70, 74, and 75). Swanson discloses that adjusting the concentrations of the alcohols and/or surfactants allows the phantom to be tuned to any clinically relevant kurtosis value (¶ 44). Swanson discloses that changing the concentration of lamellar lipid vesicles creates diffusion phantoms with tunable apparent diffusion and kurtosis values (¶ 74). 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).
Regarding claims 2-6 and 16-20, Swanson discloses that the alcohol can be cetearyl alcohol comprising a 1:1 ratio of cetyl alcohol (16-carbon chain):stearyl alcohol (18-carbon chain) (¶ 59).
Regarding claims 10 and 24, Swanson discloses the use of lactic acid as a pH buffer to maintain a pH less than 6.0 (¶ 82).
Regarding claim 12, Swanson discloses that the different ranges of imaging parameters can be achieved by altering the composition temperature, citing values at room temperature (approximately 19-25°C) (¶ 40).
Regarding claims 13-15, Swanson discloses a method for preparing the composition comprising 1) heating water, 2) heating CTAB (surfactant) in the hot water, 3) melting cetearyl alcohol on a hot plate, and 4) pouring the cetearyl alcohol into the hot CTAB solution and mixing by stirring (¶ 59). Swanson reads on the method of instant claims comprising heating the water, surfactant, and alcohol prior to mixing.
Regarding claim 34, Swanson discloses a system comprising the composition, 3T clinical magnetic resonance imaging (MRI) scanners, and a quantitative analysis software tool for data acquisition and calculation (¶ 8; ¶ 65).
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; cited on PTO-892).
As discussed above, regarding claim 1, Swanson discloses a DKI phantom comprising long-chain alcohols and surfactants in water (claims 70, 74, and 75). Swanson discloses that adjusting the concentrations of the alcohols and/or surfactants allows the phantom to be tuned to any clinically relevant kurtosis value (¶ 44). Swanson discloses that changing the concentration of lamellar lipid vesicles creates diffusion phantoms with tunable apparent diffusion and kurtosis values (¶ 74). Swanson discloses that vesicle-forming components comprising lamellar systems of alcohols and surfactants can range from a concentration of 0.25 % to 20 % by weight (¶ 51; claims 74-76).
Regarding claims 2-6 and 16-20, Swanson discloses that the alcohol can be cetearyl alcohol comprising a 1:1 ratio of cetyl alcohol (16-carbon chain):stearyl alcohol (18-carbon chain) (¶ 59).
Regarding claims 10 and 24, Swanson discloses the use of lactic acid as a pH buffer to maintain a pH less than 6.0 (¶ 82).
Regarding claim 12, Swanson discloses that the different ranges of imaging parameters can be achieved by altering the composition temperature, citing values at room temperature (approximately 19-25°C) (¶ 40).
Regarding claims 13-15, Swanson discloses a method for preparing the composition comprising 1) heating water, 2) heating CTAB (surfactant) in the hot water, 3) melting cetearyl alcohol on a hot plate, and 4) pouring the cetearyl alcohol into the hot CTAB solution and mixing by stirring (¶ 59). Swanson reads on the method of instant claims comprising heating the water, surfactant, and alcohol prior to mixing.
Regarding claims 34 and 35, Swanson discloses a system comprising the composition, 3T clinical magnetic resonance imaging (MRI) scanners, and a quantitative analysis software tool for data acquisition and calculation (¶ 8; ¶ 65). Swanson discloses the system can include a device for data analysis and calculation, and instructions for storage and execution (¶ 56).
Swanson does not disclose a software component comprising instructions for obtaining magnetic resonance data and/or calculating a magnetic resonance value that describes magnetization transfer (MT).
Cabana discloses a software package, qMTLab, designed for data simulation, analysis, and visualization to provide simple and easy quantitative MT imaging (title; abstract).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to use the software package of Cabana for the system of Swanson to efficiently analyze the data for MT. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Cabana teaches the software can be used for analyzing MRI data describing MT. Accordingly, applying the teaching of Cabana to the System of Swanson constitutes no more than the predictable use of prior art elements according to their established functions, thus rendering claim 35 obvious. The concentration of alcohols and surfactants, and the temperature of the composition of the prior art overlap with those instantly claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. The concentration of alcohols and surfactants, and the temperature of the composition are clearly result effective parameters 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 concentration of alcohols and surfactants, and the temperature of the composition in order to best achieve the desired imaging parameters as Swanson teaches the concentration and temperature determine the imaging parameters. “[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 § 2144.05.
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; cited on PTO-892).
Regarding claim 1, claim 70 of the ‘641 recites a DKI phantom comprising a high-molecular weight alcohol, an ionic surfactants, and water. Claim 73 of the ‘641 recites the high-molecular weight alcohol and ionic surfactant in an amount of 0.25% to 20% by weight. The concentration of alcohols and surfactants of the ‘641 overlap with those instantly claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. The concentration of alcohols and surfactants 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 concentration of alcohols and surfactants in order to best achieve the desired imaging parameters. “[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 § 2144.05.
Regarding claims 2-6 and 16-20, claim 72 of the ‘641 recites the high-molecular weight alcohol comprises one or more alcohols having 10-22 carbons. Claims of the ‘641 does not disclose cetearyl alcohol comprising 1:1 or 1:3 to 3:1 ratio of cetyl alcohol:stearyl alcohol. As discussed above, Swanson discloses that the alcohol can be cetearyl alcohol comprising a 1:1 ratio of cetyl alcohol:stearyl alcohol. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use cetearyl alcohol of Swanson for the composition of the ‘641. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Swanson teaches cetearyl alcohol comprising a 1:1 ratio of cetyl alcohol:stearyl alcohol can be used for the composition.
Regarding claims 10 and 24, claims of the ‘641 does not disclose a pH buffer. As discussed above, Swanson discloses the use of lactic acid as a pH buffer to maintain a pH less than 6.0 (¶ 82). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the pH buffer of Swanson for the composition of the ‘641 in order to adjust and maintain the pH of the composition. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Swanson teaches a pH buffer such as lactic acid can be used to provide and maintain a pH less than 6.0 in the composition.
Regarding claim 12, claims of the ‘641 does not disclose the temperature of the composition. As discussed above, Swanson discloses the different ranges of imaging parameters can be achieved by altering the phantom temperature, citing values at room temperature (approximately 19-25°C) (¶ 40). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the composition of the ‘641 at a room temperature. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Swanson teaches the composition can be used at a room temperature. Further, the temperature of the composition 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 temperature of the composition in order to best achieve the desired imaging parameters. “[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 § 2144.05.
Regarding claims 13-15, claim 89 of the ‘641 recites the method mixing alcohols and surfactants. Claims of the ‘641 does not disclose heating water, surfactant, and alcohol prior to mixing. As discusses above Swanson discloses a method for preparing the composition comprising heating water, surfactant, and alcohol prior to mixing (¶ 59). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the method of Swanson for the preparation of the composition of the ‘641. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Swanson teaches a method comprising heating steps before mixing for preparing the composition.
Regarding claims 34 and 35, claim 70 of the ‘641 recites a method validating DKI parameters comprising the composition, MRI scan, and determination of parameters from imaging data. The claims of the ‘641 does not disclose a software component comprising instructions for obtaining magnetic resonance data and/or calculating a magnetic resonance value that describes magnetization transfer (MT). As discussed above, Cabana discloses a software package, qMTLab, designed for data simulation, analysis, and visualization to provide simple and easy quantitative MT imaging (title; abstract). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the software package of Cabana for the system of the ‘641 to efficiently analyze the data for MT. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Cabana teaches the software can be used for analyzing MRI data describing MT.
This is a provisional nonstatutory double patenting rejection.
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.
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/ Supervisory Patent Examiner, Art Unit 1618