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 .
Claims 1-20 are pending.
Claims 1-14 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 15, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CHEN (Using [1-13C]Lactic Acid for Hyperpolarized 13C MR Cardiac Studies. Magnetic Resonance in Medicine. 2015.).
Regarding claim 15, CHEN teaches a method involving a composition of L-[1-13C]lactic acid (DNP sample preparation), which reads on a magnetic resonance (MR) probe and a glassification agent comprising lactic acid and OX63 trityl radical (DNP sample preparation), which reads on electron paramagnetic agent (EPA). The composition was polarized (DNP sample preparation), which reads on carrying out polarization on the composition to obtain a hyperpolarized amorphous solid MR probe material. The composition was then dissolved (DNP sample preparation), which reads on liquefying the hyperpolarized amorphous solid MR probe material by dissolving the hyperpolarized amorphous solid MR probe material to obtain a hyperpolarized liquid MR probe solution.
Regarding claims 19 and 20, the MR probe comprises [1-13C] lactic acid (DNP sample preparation), which reads on a 13C MR probe and an MR probe that includes lactic acid.
Note, the term “about” is a relative term and the examiner broadly interprets this as ±10%. Therefore pure lactic acid, 100%, used in CHEN, reads on “up to about 90% volume percent lactic acid”.
Claims 15, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by LAU (Cardiac metabolic imaging using hyperpolarized [1-13C]lactate as a substrate. bioRxiv. 2020.).
Regarding claim 15, LAU teaches a method of making a hyperpolarized 13C lactate MR probe (abstract). The probe is prepared by mixing [1-13C]lactic acid with 20% water, which reads on a magnetic resonance (MR) probe and a glassification agent comprising lactic acid wherein the glassification agent has a concentration up to about 80% lactic acid, and trityl radical, which reads on an EPA (Hardware and sample preparation). The mixture was then polarized (Hardware and sample preparation) and water was then added (Hardware and sample preparation), which reads on liquefying the probe material.
Regarding claims 19 and 20, the MR probe comprises [1-13C] lactic acid (Hardware and sample preparation), which reads on a 13C MR probe and an MR probe that includes lactic acid.
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.
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 15-17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over CHEN (Using [1-13C]Lactic Acid for Hyperpolarized 13C MR Cardiac Studies. Magnetic Resonance in Medicine. 2015.) or in the alternative LAU (Cardiac metabolic imaging using hyperpolarized [1-13C]lactate as a substrate. bioRxiv. 2020.) and in view of MALINOWSKI (Dissolution Dynamic Nuclear Polarization capability study with fluid path. Journal of Magnetic Resonance. 2016.).
CHEN and/or LAU teach Applicant’s invention as discussed above.
CHEN and/or LAU do not teach filtering out the EPA with the aid of an acid.
MALINOWSKI teaches a method of making hyperpolarized MR probes (abstract). The EPA used in the method is precipitated out at an acidic pH and is then removed effectively by mechanical filtration (Page 142, paragraph 1). The acceptance criterion for residual EPA in the product is less than 3μM for a human dose (Page 144, paragraph 8).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate filtering out the EPA with the aid of an acid. The person of ordinary skill in the art would have been motivated to make those modifications, because the acceptance criterion for residual EPA in the product is less than 3μM for a human dose, and reasonably would have expected success because the references are in the same field of endeavor, such as methods of making hyperpolarized MR probes.
Claims 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over CHEN (Using [1-13C]Lactic Acid for Hyperpolarized 13C MR Cardiac Studies. Magnetic Resonance in Medicine. 2015.) or in the alternative LAU (Cardiac metabolic imaging using hyperpolarized [1-13C]lactate as a substrate. bioRxiv. 2020.) in view of MALINOWSKI (Dissolution Dynamic Nuclear Polarization capability study with fluid path. Journal of Magnetic Resonance. 2016.) and in further view of GHONEIM (Recent Progress in Electrochemical pH-Sensing Materials and Configurations for Biomedical Applications. Chemical Reviews. 2019).
CHEN and/or LAU in view of MALINOWSKI teach Applicant’s invention as discussed above.
CHEN and/or LAU in view of MALINOWSKI do not teach using lactic acid as an aid for filtration.
GHONEIM teaches that lactic acid lowers pH and causes acidic conditions (page 5249, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate filtering the EPA with the aid of lactic acid. The person of ordinary skill in the art would have been motivated to make those modifications, because lactic acid lowers pH and MALINOWSKI teaches that acidic conditions cause the EPA to precipitate out for filtration and reasonably would have expected success because both CHEN and LAU teach using lactic acid in the method.
Response to Arguments
Applicant argues Applicant has amended claim 15 to recite the glassification agent has a concentration up to about 90% volume percent lactic acid. Chen reports a study using neat [l-13C]lactic acid without the addition of any solvent or glassing agents.
Examiner does not find this argument persuasive because as discussed above, the term “about” is a relative term and CHEN can be considered teaching “up to about 90%”.
Furthermore, as discussed above, LAU teaches a method of making a hyperpolarized 13C lactate MR probe (abstract). The probe is prepared by mixing [1-13C]lactic acid with 20% water, which reads on a magnetic resonance (MR) probe and a glassification agent comprising lactic acid wherein the glassification agent has a concentration up to about 80% lactic acid, and trityl radical, which reads on an EPA (Hardware and sample preparation).
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.
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/S.L.M./ Examiner, Art Unit 1618
/Michael G. Hartley/ Supervisory Patent Examiner, Art Unit 1618
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