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 .
Previously presented office action 11/20/2025 is withdrawn. See interview summary
Election/Restrictions
Applicant’s election of Group I, in claims 1-11 in the reply filed on 10/09/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Base claim 1 is rejected for being incomplete for omitting essential elements, such omission amounting to a gap between the elements, as explained below:
Claim 1 is drawn to a hydrogenation reaction, wherein the hydrogen is parahydrogen, ultimately to boost NMR signals (PHIP), ultimately for biomedical imaging. Once of skill in the art would at once recognize that such reaction would entail unsaturated compounds, converted to saturated or partially saturated compounds. That said, claim 1 does not recite the structural identities of what these chemical compounds are; what the catalyst is. These are recited as ‘precursor compound’ and ‘target compound’; the structural make-up of the reactant and product in the hydrogenation reaction is unclear. Similarly process parameters such as solvent, concentration, temperature, pressure, catalyst are also not found in the base claim. These are essential elements; for instance, the precipitation (limitation see claims 2-4) needs modification of these essential process parameters. It is unclear how polarization transferring waveform is applied to cause precipitation, because precipitation depends on the solubility of the hydrogenated target compound chemical structure, the solvent and concentration. Dependent claims do not solve the problems of the base claims. The limitation that (chemical) structure of a compound can be modified by electromagnetic stimulation just does not make sense. For example (UV) radiation can modify double bond geometry resulting in change in chemical structure (and thus change the solubility of the modified, hydrogenated compound). Likewise, while, hydrolysis using (sodium hydroxide) can result in precipitation of the sodium salt of the product, in non-aqueous solvent, it is unclear how electromagnetic stimulation induce precipitation. See instant Fig 7a for implied release of pyruvate (a carboxylate) requiring hydroxide for hydrolysis in non-aqueous media. There is no recitation in claims for such a step. Also see claim 7, which recites partial structures for the target compound.
As such multiple essential steps are needed for ‘precipitating’, ‘separating’ or ‘generating’
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none of which is recited in the claims.
On top of this, the open-ended comprising language, renders the scope of the claim 1 indefinite. “Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("comprising" leaves "the claim open for the inclusion of unspecified ingredients even in major amounts").
The word ‘comprising’ transitioning from the preamble to the body of the claim, signals that the entire claim is presumptively open-ended. As noted above, base claim 1 does not recite what process parameter is used to cause precipitation. Consider limitations of claims 2 and 3. One of skill in the art would expect, raise in temperature is to increase solubility and while decrease in temperature would promote precipitation, or chemical methods of hydrolysis or protonation can cause precipitation depending on the solvent.
Claim 4 recites confusing limitations, that is process parameters that finds no definitions or support in the specification. Applicant is encouraged to point out how electromagnetic simulation causes precipitation or provide prior art citations for this. Note that this is not an enablement issue rather a clarity problem. Even if there is a structural change, such as cis-trans isomerism or conformational change by electromagnetic simulation, these would be dependent on structure of the chemical compounds involved before and after hydrogenation. In the absence of many definition of many critical terms, a comprehensive patent search cannot be done. Many limitations in dependent claims that is/are of commonsense, do(es) not clarify the process of the base claim. Consider for example, claim 5: one of skill in the art would anticipate that any precipitation from the original solution containing the target, is anticipated to reduced the concentration of the target compound in the (second) solution after precipitations. Claim 6 recited ‘transporting’. It is unclear it is unclear how this is done. Claim 7 is drawn to ionic carboxylates without reciting the counter ions. The meaning of the ‘phrase polarization transferring waveform’ in claim 9, is unclear as there is no definition of this in the specification. Claim 11 implies a chemical reaction such as hydrolysis without reciting any reagent or what is being cleaved from what. Many biochemical mechanism known in the art (see citations) below are implied throughout the claims.
As such dependent claims 2-11 do not solve the problem of the base claim. Therefore claims 2-11 are rejected as well.
Note that in general, a process should at least recite a positive, active step and any process parameters necessitated by the specification so that the claim will "clearly set out and circumscribe a particular area with a reasonable degree of precision and particularity” In re Moore, 169 USPQ 236, and make it clear what subject matter the claim encompasses, as well as make clear the subject matter from others would be precluded.
Further note that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Also see, In re Zletz, 13 USPQ2d 1320, 1322. “An essential purpose of patent examination is to fashion claims that are precise, clear, correct and unambiguous.”
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Eills, Real-Time Nuclear Magnetic Resonance Detection of Fumarase, Activity Using Parahydrogen-Hyperpolarized [1-13C]Fumarate, J. Am. Chem. Soc. 2019, 141, 20209−20214. Ripka Hyperpolarized fumarate via parahydrogen. Chem. Commun. 2018, 54, 12246−12249; Eills Preservation of nuclear spin order byprecipitation. ChemPhysChem 2018, 19, 40−44;Truong, 15N Hyperpolarization by Reversible Exchange Using SABRE-SHEATH, The Journal of Physical Chemistry C, vol. 119, no. 16, 10 April 2015. 8786-8797; Wagner, Devices And Methods For Parahydrogen Induced Polarization, US 9821290 and Goodson, Cleavable agent for enhanced magnetic resonance, US 20200172493.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625