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 invention group II in the reply filed on 5/4/26 is acknowledged.
Claims 8-13, 22, 24, 31-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4, 16-18, 21, 23, 26-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea in the form of a mathematical relationship without significantly more. In particular, the mathematical relationship is the idea of associating test results with settings of a mass spectrometer, a process which can, and has, been performed mentally and with pen and paper for decades. Specifically, the claim recites “acquiring a plurality of mass spectral (MS) datasets each corresponding to one of the applied plurality of instrument parameter values; encoding each of the plurality of MS datasets to generate a corresponding plurality of MS results each corresponding to one of the applied instrument parameter values; and compiling and storing the MS datasets and MS results in a spectral library in association with the applied instrument parameter values.” Simply put, these are descriptions of collecting and associating data.
This judicial exception is not integrated into a practical application because there is no claimed application of the associated data. Instead, the entire remainder of the claim is directed to data gathering steps.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because all of the remaining steps are descriptions of generic data gathering steps, e.g., “receiving…at least one known sample”, or generic extra-solution mass spectrometer setup steps, e.g., “modulating at least one instrument parameter of the mass spectrometer” or “analyzing the at least one sample while applying each of the plurality of instrument parameter values.” Such steps are notoriously well known, and have been practiced since at least 1992, when US 5,218,204 was filed, therein describing the technique of changing the DC potential applied to a skimmer to improve ion beam intensity. US 5,218,204 at 3:20-47.
The courts have found mere data gathering to be insignificant extra-solution activity. In Mayo Collaborative Servs. v. Prometheus Labs. Inc, 566 U.S. 66, 79, 101 USPQ2d 1961, 1968 (2012) the courts found determining the level of a biomarker in blood was found to be insignificant extra-solution activity. Further, in PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012), the courts found assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis, was found to be insignificant extra-solution activity. Likewise, the step of obtaining a mass spectrum for later use in making an association is insignificant extra-solution data gathering.
Finally, mass spectrometer setup limitations only act to link the abstract ideas to the general field of mass spectrometry. In Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016), the court found that limiting an abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to data related to the electric power grid, because limiting application of the abstract idea to power-grid monitoring is simply an attempt to limit the use of the abstract idea to a particular technological environment. Likewise, the steps of varying a parameter of a mass spectrometer describe a generic process that simply looks to link the abstract idea of associating data to the environment of a mass spectrometer, and is not significantly more than the abstract idea itself.
Dependent claims 4, 16-18, 21, 23, 27, and 28 fail to provide a practical application to the above abstract ideas, as they offer no application whatsoever, but rather describe the parameters of the mass spectrometer which are to be modulated so as to provide further associations. Furthermore, dependent claims 4, 16-18, 21, 23, 27, and 28, taken alone or in an ordered combination, fail to recite anything that is significantly more than the abstract idea at issue. Rather, the claims describe the parameters of the data gathering and are not significantly more that the abstract idea for the same reasons as noted above with respect to claims 1 and 26. Claims 27 and 28 describe recording data using a generic computer and components thereof, which is also not significantly more than the abstract idea. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014).
Since the above abstract idea is neither practically applied nor claimed with elements that might be considered to be significantly more than just the abstract ideas, the claims are rejected for failing the requirements of 35 USC 101.
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 21 is 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. Claim 21 depends from a canceled claim, and as such, is indefinite. The claim will be interpreted as though it depended from claim 1.
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.
Claims 1, 4, 17-18, 21, 23, 26-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2005/0167582 A1 [Zavitsanos]
Regarding Claim 1:
Zavitsanos teaches a method for mass spectrometry (abstract), the method comprising:
receiving, by a mass spectrometer via a sampling system operably connected thereto (para 20), at least one sample containing at least one known compound (paras 26, 37-38);
modulating at least one instrument parameter of the mass spectrometer through a plurality of instrument parameter values (paras 28-32, 39);
analyzing the at least one sample while applying each of the plurality of instrument parameter values (paras 33-34);
acquiring a plurality of mass spectral (MS) datasets each corresponding to one of the applied plurality of instrument parameter values (paras 33-34);
encoding each of the plurality of MS datasets to generate a corresponding plurality of MS results each corresponding to one of the applied instrument parameter values (para 35); and
compiling and storing the MS datasets and MS results in a spectral library in association with the applied instrument parameter values (paras 37-39 the spectral conditions are associated with spectra for the known compounds and both are stored).
Regarding Claim 4:
Zavitsanos teaches the method of claim 1, wherein the modulating the at least one instrument parameter comprises at least one of:
modulating through a plurality of instrument parameter values while analyzing a single sample (paras 29-32).
Regarding Claim 17:
Zavitsanos teaches the method of claim 1, wherein the at least one instrument parameter comprises at least one of:
a collision energy (CE);
an electron energy;
a parameter related to fragmentation;
a parameter related to ionization;
a parameter related to the introduction of ions to a quadrupole ion guide; or
a parameter that controls an ion mobility device. Paras 29-32.
Regarding Claim 18:
Zavitsanos teaches the method of claim 1, wherein:
the mass spectrometer comprises an ionization source, a collision cell, and an ion detector (para 20);
the collision cell comprises at least one fragmentation module selected from: collision induced dissociation (CID), surface induced dissociation (SID), electron capture dissociation (ECD), electron transfer dissociation (ETD), metastable-atom bombardment, photo-fragmentation, or combinations thereof (para 20);
the at least one instrument parameter comprises a fragmentation parameter that controls the fragmentation module (paras 29-32), and
the plurality of instrument parameter values comprises a plurality of fragmentation parameter values (paras 28-32);
the method further comprising:
producing precursor ions of each sample in the ionization source (that is what API does);
transmitting the precursor ions of each sample into the collision cell (by definition, the CID fragments the precursor ions transmit thereto);
generating fragment ions from the precursor ions of each sample in the collision cell under each of the applied modulated fragmentation parameter (paras 28-32); and
detecting the precursor and fragment ions using the ion detector (paras 32-33),
wherein the MS results comprise at least one MSMS spectrum generated for each fragmentation parameter value (paras 28-32).
Regarding Claim 21:
Zavitsanos teaches the method of claim 1, further comprising generating, from the MSMS spectra, a plurality of fragmentation results each corresponding to one of the applied fragmentation parameter values (paras 28-32), wherein the plurality of fragmentation results comprise at least one of:
a spectral feature indicative of the precursor and fragment ions for each sample (para 25).
Regarding Claim 23:
Zavitsanos teaches a method for mass spectrometry, the method comprising:
generating a plurality of MS results for a plurality of known compounds by repeating the method according to claim 1 or an operation thereof (Fig. 3); and
compiling and storing the plurality of MS results corresponding to the plurality of known compounds in the spectral library (paras 30-35).
Regarding Claim 27:
Zavitsanos teaches a system comprising:
a mass spectrometer (para 20);
a high-throughput sampling system operative to introduce a plurality of samples to the mass spectrometer (para 20);
a processor operatively coupled to the high-throughput sampling system and the mass spectrometer (paras 65-68); and
memory, coupled to the processor, the memory storing instructions that, when executed by the processor, perform operations comprising the method of claim 1 (e.g., Fig. 6).
Regarding Claim 26:
Zavitsanos teaches a method for mass spectrometry, comprising:
receiving, by a mass spectrometer via a sampling system operably connected thereto (para 20), at least one sample containing at least one known compound (paras 26, 37-38), wherein the mass spectrometer comprises an ionization source, a collision cell comprising at least one fragmentation module, and an ion detector (para 20);
modulating at least one fragmentation parameter of the mass spectrometer through a plurality of fragmentation parameter values (paras 28-32, 39);
analyzing the at least one sample while applying each of the plurality of fragmentation parameter values (paras 33-34);
producing precursor ions of each sample in the ionization source (para 25, also API in para 20);
transmitting the precursor ions of each sample into the collision cell (by definition, the CID fragments the precursor ions transmit thereto);
generating fragment ions from the precursor ions of each sample in the collision cell under each of the applied fragmentation parameter values (paras 28-32);
detecting the precursor and fragment ions of each sample using the ion detector (paras 32-33);
acquiring a plurality of mass spectral (MS) datasets each corresponding to one of the applied plurality fragmentation parameter values (paras 33-34);
encoding each of the plurality of MS datasets to generate a corresponding plurality of MS results each corresponding to the applied fragmentation parameter value (para 35),
wherein the MS results comprise at least one MSMS spectrum generated for each instrument parameter value (paras 28-32);
generating, from the MSMS spectra, a plurality of fragmentation results each corresponding to one of the applied fragmentation parameter values (paras 28-32); and
compiling and storing the MS datasets and MS results in a spectral library in association with the applied fragmentation parameter values (paras 37-39 the spectral conditions are associated with spectra for the known compounds and both are stored).
Regarding Claim 28:
Zavitsanos teaches a computer program product, comprising a non-transitory computer-readable storage medium whose contents include a program with instructions being executed on a processor so as to perform the method of claim 26 (e.g., Fig. 6), the method further comprising determining, for the at least one known compound, a relationship of the MS results with the modulated instrument parameter (paras 35-36).
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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Zavitsanos in view of US 2019/0157060 A1 [Datwani].
Regarding Claim 16:
Zavitsanos teaches the method of claim 1, but fails to teach that:
the sampling system comprises an Acoustic Droplet Ejector (ADE) operably coupled to an Open Port Interface (OPI); and
each of the plurality of samples is ejected from a sample volume by the ADE and introduced to the mass spectrometer through the OPI.
Datwani teaches a mass spectrometer using a sampling system comprising an Acoustic Droplet Ejector (ADE) operably coupled to an Open Port Interface (OPI) (Figs. 1 & 2, paras 64-65);; and
each of the plurality of samples is ejected from a sample volume by the ADE and introduced to the mass spectrometer through the OPI (paras 96-98).
It would have been obvious to one of ordinary skill in the art before the effective time of filing to replace the generic ionization and sampling source of Zavitsanos with the ADE/OPI ionization and sampling source of Datwani. One would have been motivated to do so since this would provide a litany of benefits such as high throughput, quantitation with excellent dynamic range, and kinetic measurement in real time. Datwani para 30.
Conclusion
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WYATT STOFFA
Primary Examiner
Art Unit 2881
/WYATT A STOFFA/Primary Examiner, Art Unit 2881
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