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, see applicant arguments/remarks, filed 06/15/2026, with respect to the 112 rejection of claim 8 have been fully considered and are persuasive. The 112 rejection of claim 8 has been withdrawn.
Applicant's arguments filed 06/15/2026 regarding the prior art rejection of claim 1 have been fully considered but they are not persuasive.
The applicant argues that prior art Prado and Sacolick do not teach "determin[ing] fat content measurement for the organ based on a ratio of an amplitude of the fat contribution signal to an amplitude of the NMR response signals." Further, Applicant argues that Prado also discloses "Proton Density Fat Fraction (PDFF), may be used to assist with the determination of liver fat content." Prado at [0099]. While Prado generally discloses a PDFF, and generally discloses a ratio of signal amplitudes, Prado does not disclose determining fat content based on a ratio of the fat contribution signal to the amplitude of the total signal. Rather, Prado discloses comparing the amplitude of the first set of signals to an amplitude of the second set of signals.
The examiner respectfully disagrees. Prado does teach "determin[ing] fat content measurement for the organ based on a ratio of an amplitude of the fat contribution signal to an amplitude of the NMR response signals" because Prado does teach PDFF. Specifically, Prado teaches “the ratio of the number of protons of mobile triglycerides and the number of protons of mobile water and mobile triglycerides, or Proton Density Fat Fraction (PDFF), may be used to assist with the determination of liver fat content” [¶0099]. Therefore, Prado does teach determining fat content measurement for the organ based on a ratio of an amplitude of the fat contribution signal (mobile triglycerides) to an amplitude of the NMR response signal (mobile triglycerides + mobile water). Further, the applicant’s limitation "determin[ing] fat content measurement for the organ based on a ratio of an amplitude of the fat contribution signal to an amplitude of the NMR response signals" corresponds to determining PDFF according to the applicant’s specification [See 0037 of applicant’s specification]. Therefore, the PDFF disclosed by Prado is the same as the PDFF disclosed by the applicant. In conclusion, the arguments are not considered persuasive and the prior art rejection stands.
The same response to arguments above also apply to the arguments of claim 6.
Claim Rejections - 35 USC § 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 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.
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Prado (US 2019/0076080), in view of Sacolick (US 2016/0131727).
Regarding claim 1, Prado teaches a non-invasive health measurement system comprising:
an open magnet Nuclear Magnetic Resonance (NMR) apparatus to obtain NMR response signals generated by atomic nuclei of substances comprising an organ, the NMR response signals comprising a fat contribution signal and a water contribution signal [See open magnet. See Fig. 10-11. See also rest of reference.];
a processor [See Fig. 13. See also rest of reference.]; and
a memory communicably coupled to the processor and storing instructions that, when executed by the processor [See Fig. 13. See also rest of reference.], cause the processor to:
transmit radio frequency (RF) pulses in the presence of a field gradient into the organ with the open magnet NMR apparatus [See pulse sequence. See also rest of reference.];
obtain the NMR response signals [See pulse sequence. See also rest of reference.];
separate the water contribution signal and the fat contribution signal based on their spin-spin (T2) relaxation times [¶0097, wherein T2 is used to help quantify the relative amounts fat to water. ¶0062, ¶0099-0110. See also rest of reference.] by a multi-echo sequence [See CPMG. See ¶0099-0110. See echo train. ¶0103. See also rest of reference.] to execute a diffusion encoding sequence [See diffusion parameter. See also rest of reference.]; and
determine fat content measurement for the organ based on a ratio of an amplitude of the fat contribution signal to an amplitude of the NMR response signals [¶0099, wherein “the ratio of the number of protons of mobile triglycerides and the number of protons of mobile water and mobile triglycerides, or Proton Density Fat Fraction (PDFF), may be used to assist with the determination of liver fat content” teaches the limitation. The PDFF disclosed by Prado is also the same as the PDFF and ratio claimed and disclosed by the applicant’s specification in [0037] of the instant application.].
Prado is silent in teaching by applying preparation pulses.
Sacolick, which is also in the field of MRI, teaches by applying preparation pulses followed by an echo sequence to execute a diffusion encoding sequence [¶0054, ¶0084. See also rest of reference.].
It would have been obvious to a person having ordinary skill in the art before the filing date of the claimed invention to combine the teachings of Prado and Sacolick because both references are in the field of open MRI and because Prado teaches acquiring a diffusion parameter, and Sacolick teaches it is known in the art to use diffusion weighted preparations [Sacolick - ¶0054, ¶0084. See also rest of reference.] to acquire diffusion signals.
Regarding claim 2, Prado and Sacolick teach the limitations of claim 1, which this claim depends from.
Prado further teaches wherein separating the water contribution signal and the fat contribution signal based on their T2 relaxation times comprises:
collecting a Carr-Purcell-Meiboom-Gill (CPMG) time series [See CPMG. See ¶0099-0110. See also rest of reference.];
performing a double exponential least square fit to the CPMG time series [Fig. 11B. ¶0065-0066, ¶0099-0110. See also rest of reference.]; and
computing amplitudes of the fat contribution signal and the water contribution signal based on the double exponential least square fit [Fig. 11B. ¶0065-0066, ¶0099-0110. See also rest of reference.].
Regarding claim 3, Prado and Sacolick teach the limitations of claim 2, which this claim depends from.
Prado further teaches wherein a short echo time is used to minimize diffusion effects [¶0103, wherein T2 is calculated and diffusion effects are reduced by using short time windows between RF pulses (which means shorter echo time). See also rest of reference.].
Regarding claim 5, Prado and Sacolick teach the limitations of claim 2, which this claim depends from.
Prado further teaches wherein separating the water contribution signal and the fat contribution signal based on their T2 relaxation times comprises measuring the T2 relaxation time for fat protons by suppressing a diffusion coefficient [¶0103, wherein T2 is calculated and diffusion effects are reduced by using short time windows between RF pulses (which means shorter echo time). See also rest of reference.].
Regarding claim 6, Prado teaches a non-invasive health measurement system comprising:
an open magnet Nuclear Magnetic Resonance (NMR) apparatus to obtain NMR response signals generated by atomic nuclei of substances comprising an organ, the NMR response signals comprising a fat contribution signal and a water contribution signal [See open magnet. See Fig. 10-11. See also rest of reference.];
a processor [See Fig. 13. See also rest of reference.]; and
a memory communicably coupled to the processor and storing instructions that, when executed by the processor [See Fig. 13. See also rest of reference.], cause the processor to:
transmit radio frequency (RF) pulses in the presence of a field gradient into the organ with the open magnet NMR apparatus [See pulse sequence. See also rest of reference.];
obtain the NMR response signals [See pulse sequence. See also rest of reference.];
separate the water contribution signal and the fat contribution signal based on their spin-lattice (T1) relaxation times [¶0097, wherein T1 is used to help quantify the relative amounts fat to water. ¶0062, ¶0099-0111. See also rest of reference.] by applying a multi-echo sequence [See CPMG. See ¶0099-0110. See echo train. ¶0103. See also rest of reference.] to execute a diffusion encoding sequence [See diffusion parameter. See also rest of reference.]; and
determine fat content measurement for the organ based on a ratio of an amplitude of the fat contribution signal to an amplitude of the NMR response signals [¶0099, wherein “the ratio of the number of protons of mobile triglycerides and the number of protons of mobile water and mobile triglycerides, or Proton Density Fat Fraction (PDFF), may be used to assist with the determination of liver fat content” teaches the limitation. The PDFF disclosed by Prado is also the same as the PDFF and ratio claimed and disclosed by the applicant’s specification in [0037] of the instant application.].
Prado is silent in teaching by applying preparation pulses.
Sacolick, which is also in the field of MRI, teaches by applying preparation pulses followed by a multi-echo sequence to execute a diffusion encoding sequence [¶0054, ¶0084. See also rest of reference.].
It would have been obvious to a person having ordinary skill in the art before the filing date of the claimed invention to combine the teachings of Prado and Sacolick because both references are in the field of open MRI and because Prado teaches acquiring a diffusion parameter, and Sacolick teaches it is known in the art to use diffusion weighted preparations [Sacolick - ¶0054, ¶0084. See also rest of reference.] to acquire diffusion signals.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited Prado, in view of previously cited Sacolick, and in further view of Ookawa (US 2017/0363699).
Regarding claim 4, Prado and Sacolick teach the limitations of claim 2, which this claim depends from.
Prado further teaches separating the water contribution signal and the fat contribution signal based on their T2 relaxation times comprises measuring the T2 relaxation time [¶0097, wherein T2 is used to help quantify the relative amounts fat to water. ¶0062, ¶0099-0110. See also rest of reference.].
Prado and Sacolick are silent in teaching wherein separating the water contribution signal and the fat contribution signal by suppressing the water signal based on T1.
Ookawa, which is also in the field of MRI, teaches separating the water contribution signal and the fat contribution signal by suppressing the water signal based on T1 [¶0129. See also Fig. 10 and rest of reference.].
It would have been obvious to a person having ordinary skill in the art before the filing date of the claimed invention to combine the teachings of Prado and Sacolick with the teachings of Ookawa because all methods are in the field of MRI and separating water and fat and because Ookawa teaches it is known in the art to suppress water/fat based on T1/T2 [Ookawa - ¶0129. See also Fig. 10 and rest of reference.].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited Prado, in view of previously cited Sacolick, and in further view of Reeder (US 2018/0275235).
Regarding claim 7, Prado and Sacolick teaches the limitations of claim 6, which this claim depends from.
Prado further teaches wherein separating the water contribution signal and the fat contribution signal based on their T1 relaxation times comprises: performing a double exponential fit of the measured NMR signal amplitudes [Fig. 11B. ¶0065-0066, ¶0099-0111. See also rest of reference.]; determining signal amplitudes values for water and for fat, independently of T2 values, based on the double exponential fit [Fig. 11B. ¶0065-0066, ¶0099-0111. See also rest of reference.]; and determining T1 relaxation times for water and for fat, independently of T2 values, based on the double exponential fit [Fig. 11B. ¶0062-0066, ¶0097-0111. See also rest of reference.].
However, Prado and Sacolick are silent in teaching collecting an echo train using varying recycling delays (rd), the echo train being shorter than a shortest T2 value; measuring the NMR signal amplitudes over the range of rd values.
Reeder, which is also in the field of MRI, teaches collecting an echo train using varying recycling delays (rd), the echo train being shorter than a shortest T2 value [¶0057-0067. See also rest of reference.]; measuring the NMR signal amplitudes over the range of rd values [¶0057-0067. See also rest of reference.].
It would have been obvious to a person having ordinary skill in the art before the filing date of the claimed invention to combine the teachings of Prado and Sacolick with the teachings of Reeder because all methods are in the field of MRI and water/fat separation and because Reeder teaches it is known in the art to adjust the TR to generate T1 weighting [Reeder - ¶0057-0067. See also rest of reference.].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited Prado, in view of previously cited Sacolick, and in further view of Reeder, and in furthest view of Jeong (US 2018/0049665).
Regarding claim 8, Prado, Sacolick, and Reeder teach the limitations of claim 7, which this claim depends from.
Prado further teaches wherein separating the water contribution signal and fat contribution signal based on their T1 relaxation times comprises: performing a single exponential fit to the NMR signal measurements; and computing T1f based on the single exponential fit [Fig. 11B. ¶0065-0066, ¶0099-0111. See also rest of reference.]; and separately computing T1w comprising: performing a single exponential fit to the NMR signal measurements [Fig. 11B. ¶0065-0066, ¶0099-0111. See also rest of reference.]; and computing T1w based on the single exponential fit [Fig. 11B. ¶0065-0066, ¶0099-0111. See also rest of reference.].
However, Prado and Sacolick is silent in teaching computing T1f comprising: performing NMR signal measurements at varying rd values and adding echoes; applying an NMR diffusion encoding sequence to suppress the water contribution signal; collecting a single echo with diffusion encoding at varying rd values; setting an rd value larger than T1f such that as T1w becomes much larger than T1f the fat contribution becomes effectively constant.
Reeder further teaches performing NMR signal measurements at varying rd values and adding echoes [¶0057-0067. See also rest of reference.]; setting an rd value much larger than T1f such that as T1w becomes much larger than T1f the fat contribution becomes effectively constant [¶0057-0067. See also rest of reference.].
It would have been obvious to a person having ordinary skill in the art before the filing date of the claimed invention to combine the teachings of Prado and Sacolick with the teachings of Reeder because all methods are in the field of MRI and water/fat separation and because Reeder teaches it is known in the art to adjust the TR to generate T1 weighting [Reeder - ¶0057-0067. See also rest of reference.].
However, Prado, Sacolick, and Reeder are silent in teaching applying an NMR diffusion encoding sequence to suppress the water contribution signal; collecting a single echo with diffusion encoding.
Jeong, which is also in the field of MRI, teaches applying an NMR diffusion encoding sequence to suppress the water contribution [¶0043, ¶0047. See also rest of reference.]; collecting a single echo with diffusion encoding [¶0043, ¶0047. See also rest of reference.].
It would have been obvious to a person having ordinary skill in the art before the filing date of the claimed invention to combine the teachings of Prado, Sacolick and Reeder with the teachings of Jeong because Jeong teaches it is known in the art to use high b-values to suppress water signals [Jeong - ¶0043, ¶0047. See also rest of reference.].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2022/0110580 teaches determining water and fat signals using T2 [¶0047 and ¶0094].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RISHI R PATEL whose telephone number is (571)272-4385. The examiner can normally be reached Mon-Thurs 7 a.m. - 5 p.m..
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, Eman Alkafawi can be reached at 571-272-4448. 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.
/RISHI R PATEL/Primary Examiner, Art Unit 2858