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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 22, 2024 is being considered by the examiner.
Response to Amendment
Receipt is acknowledged of the Preliminary Amendment filed on October 22, 2024. Accordingly, claims 1-20 are currently pending in the application.
Claim Interpretation
According to MPEP 2112.02: Process Claims, it is noted that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device” (emphasis added). It is also noted in that same MPEP section that “The Federal Circuit upheld the Board’s finding that "Donley inherently performs the function disclosed in the method claims on appeal when that device is used in ‘normal and usual operation’" and found that a prima facie case of anticipation was made out” (emphasis added). Id. at 138, 801 F.2d at 1326. It was up to applicant to prove that Donley's structure would not perform the claimed method when placed in ambient light.).”
With regard to claims 10-20, these claims present a method for hyperpolarizing a substrate according to the hyperpolarization system (SABRE systems) of claims 1-9. Therefore, the argument made against claims 1-9 also applies, mutatis mutandis, to claims 10-20. In addition, it is clearly seen that claims 10-20 are process claims which present a process of using the system as claimed in claims 1-9, respectively.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 10, 11, 18 and 19 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Eriksson et al. (NPL: “Improving SABRE hyperpolarization with highly nonintuitive pulse sequences: Moving beyond avoided crossings to describe dynamics”).
Eriksson et al. teaches an improving SABRE hyperpolarization with highly nonintuitive pulse sequences comprising:
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With regard to claims 1 and 10, a hyperpolarization system (SABRE systems) comprising: a solution (SABRE solution) comprising at least parahydrogen, a polarization transfer complex (PTC) (FIG. 2, [Ir(H)i (IMes)(pyrh (15N-acetonitrile)]), and substrate molecules ([15N-acetonitrile, pyridine, methanol-d4]) (Page 9 of 11, section MATERIALS AND METHODS: “Liquid nitrogen parahydrogen generator” and “Preparation of SABRE sample”); at least one magnetic field controller (arbitrary waveform generator AWG) (Page 9 of 11, section MATERIALS AND METHODS: “Application of field sequences”), the least one magnetic field controller (arbitrary waveform generator AWG) configured to: apply a static ultra-low magnetic field ((Bd+BP)/2) (Fig. 9: BP varying in the range from -18µT to +18µT) to the solution (SABRE solution); and apply an alternating ultra-low magnetic field ((Bd-BP)/2) (Fig. 9: Bd set to -34µT) to the solution (SABRE solution), wherein the system is configured to hyperpolarize at least some of the substrate molecules ([15N-acetonitrile, pyridine, methanol-d4]) after the static magnetic field and alternating magnetic field are applied (Fig. 9B), wherein the ultra-low magnetic fields are each in a range from 0.001 microtesla to 39,999 microtesla (Fig. 9).
With regard to claims 2 and 18, application of the static ultra-low magnetic field ((Bd+BP)/2) (Fig. 9: BP varying in the range from -18µT to +18µT) and the alternating ultra-low magnetic field ((Bd-BP)/2) (Fig. 9: Bd set to -34µT) occurs at substantially the same time (Fig. 9).
With regard to claims 3 and 19, at least one of the static ultra-low magnetic field and the alternating ultra-low magnetic field is variable (Fig. 9B).
With regard to claim 11, creating the PTC (FIG. 2, [Ir(H)i (IMes)(pyrh (15N-acetonitrile)]) via a pre-catalyst, wherein interaction of the parahydrogen with the pre-catalyst creates the PTC (FIG. 2, [Ir(H)i (IMes)(pyrh (15N-acetonitrile)]) (Page 7 of 11, left column).
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 4-8 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eriksson et al. in view of Adelabu et al. (NPL: “Order-Unity 13 C Nuclear Polarization of [1-13C]Pyruvate in Seconds and the Interplay of Water and SABRE Enhancement”)
Eriksson et al. teaches all as discussed in the above rejection of claims 1-3, 10, 11, 18 and 19 including the magnetic field controller (arbitrary waveform generator AWG), substrate molecules ([15N-acetonitrile, pyridine, methanol-d4]), the static ultra-low magnetic field ((Bd+BP)/2) and the alternating ultra-low magnetic field ((Bd-BP)/2) are each in a microtesla range (Fig. 9) as discussed in the above rejection of claims 1-3, 10-12 and 18-20, but it does not explicitly teach the following features:
[1-13C]pyruvate molecules, and wherein the static ultra-low magnetic field and the alternating ultra-low magnetic field are each in a microtesla range.
Dimethyl sulfoxide (DSMO) molecules, and wherein the hyperpolarization of at least some of the substrate molecules includes hyperpolarization of the [1-13C]pyruvate molecules.
To apply the static ultra-low magnetic field parallel to the alternating ultra-low magnetic field.
To apply the static ultra-low magnetic field orthogonal to the alternating ultra-low magnetic field.
The static ultra-low magnetic field has from one to three spatial directions or components.
Adelabu et al. teaches an Order-Unity 13C Nuclear Polarization of [1-13C]Pyruvate in Seconds and the Interplay of Water and SABRE Enhancement comprising:
With regard to claims 4 and 13, further including [1-13C]pyruvate molecules (Page 131: right column continued to the next page; and pages 134-135: Conclusions).
With regard to claims 5 and 14, further including dimethyl sulfoxide (DSMO) molecules, and wherein the hyperpolarization of at least some of the substrate molecules includes hyperpolarization of the [1-13C]pyruvate molecules (Abstract; Figure 1 page 131: right column continued to the next page; and pages 134-135: Conclusions).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the improving SABRE hyperpolarization with highly nonintuitive pulse sequences of Eriksson et al. to utilize [1-13C]pyruvate molecules and dimethyl sulfoxide (DSMO) molecules as taught by Adelabu et al. since Adelabu et al. teaches that such an arrangement is beneficial to provide a leading SABRE-hyperpolarized contrast agent that is commonly used in combination with DMSO in the frame of SABRE.
It is noted that:
With regard to claims 6 and 15, applying the static ultra-low magnetic field parallel to the alternating ultra-low magnetic field is well-known and heavily studied in biophysics and magnetobiology since it creates a resonant environment that maximizes the transfer of energy to specific ions or molecules. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the improving SABRE hyperpolarization with highly nonintuitive pulse sequences of Eriksson et al. to apply the static ultra-low magnetic field parallel to the alternating ultra-low magnetic field since such an arrangement is beneficial to create a resonant environment that maximizes the transfer of energy to specific ions or molecules.
With regard to claims 7 and 16, applying the static ultra-low magnetic field orthogonal to the alternating ultra-low magnetic field is well-known and heavily studied in biomagnetic field since it breaks spatial symmetry, creating optimal resonance conditions. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the improving SABRE hyperpolarization with highly nonintuitive pulse sequences of Eriksson et al. to apply the static ultra-low magnetic field parallel to the alternating ultra-low magnetic field since such an arrangement is beneficial to allow for selective targeting of specific chemical species, increases reaction yields of radical pairs, and enhances both spatial resolution and signal-to-noise ratios in ultra-low-field sensing.
With regard to claims 8 and 17, it is well-known to one having ordinary skill in the art that a magnetic field is a vector quantity, it possesses both magnitude and direction. To completely define its geometry, measure its strength, or map its effect on matter, the magnetic field at any given point in space must be represented by 3-dimensional components (Bx, By, Bz) corresponding to the Cartesian axes. Therefore, it is an inherent feature that the static ultra-low magnetic field has from one to three spatial directions or components.
With regard to claim 9, Eriksson et al. teaches that the PTC (FIG. 2, [Ir(H)i (IMes)(pyrh (15N-acetonitrile)]) is formed via a pre-catalyst, and wherein the pre-catalyst includes (IrCl(COD)(IMes) (Page 7 of 11, left column).
With regard to claim 12, Eriksson et al. teaches the pre-catalyst includes (IrCl(COD)(IMes) (Page 7 of 11, left column), the static ultra-low magnetic field ((Bd+BP)/2) (Fig. 9: BP varying in the range from -18µT to +18µT) and the alternating ultra-low magnetic field ((Bd-BP)/2) (Fig. 9: Bd set to -34µT). It is noted that the feature upon which applicants rely (i.e., “in a range from 0.001 microtesla to 999 microtesla”) will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such potential is critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). Please see MPEP 2144.05 II. OPTIMIZATION OF RANGES: Optimization Within Prior Art Conditions or Through Routine Experimentation.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the improving SABRE hyperpolarization with highly nonintuitive pulse sequences of Eriksson et al. to apply the magnetic fields in a range as identified above since such an arrangement is beneficial to improve upon what is already generally known to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.
With regard to claim 20, Eriksson et al. teaches that at least one of the static ultra-low magnetic field and the alternating ultra-low magnetic field is variable (Fig. 9B).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Applicants’ attention is invited to the followings whose inventions disclose similar devices.
Chekmenev et al. (US 11,016,152 B2) teaches a method for creating hyperpolarization at microtesla magnetic fields.
Duckett et al. (US 11,389,551 B2) teaches a polarisation transfer via a second metal complex.
Williams et al. (US 11,525,879 B2) teaches a systems for J-coupled nuclear magnetic resonance.
Swenson et al. (US 2025/0244419 A1) teaches an infusion device for the preparation and delivery of MRI probes.
Swenson et al. (US 2025/0242340 A1) teaches SABRE catalysts containing fluorinated carbon chains for delivery of metal-free MRI contrast agents.
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HOAI-AN D. NGUYEN
Primary Examiner
Art Unit 2858
/HOAI-AN D. NGUYEN/ Primary Examiner, Art Unit 2858
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