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 .
Response to Arguments
Applicant’s arguments, see pages 7-10, filed 01/05/2026, with respect to the rejections of claims 1-5, 10-13, 16-17, and 19-20 under 35 U.S.C. § 102(a)(2), and of claims 6-9, 14-15, and 18, under 35 U.S.C. § 103, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of newly found prior art references as described below.
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.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Mcalister et al. (US20200051800), hereinafter referred to as Mcalister, and in further view of Yasumitsu Ogra et al, “Effects of deuterium in octupole reaction and collision cell ICP-MS on detection of selenium in extracellular fluids”, 4 December 2005, Analytica Chimica Acta, Volume 554, Issued 1-2, 123-129, hereinafter referred to as Ogra.
Regarding claim 1, Mcalister teaches an analytical instrument, the analytical instrument comprising: one or both of an ion trap or a collision cell (fig. 1A as annotated below).
Mcalister fails to teach wherein one or both of the ion trap or the collision cell is filled with deuterium gas.
However, Ogra teaches wherein one or both of the ion trap or the collision cell is filled with deuterium gas (In this study, the utility of deuterium (D2) in place of H2 as a reaction gas was clarified (para. [0004])) (Table 1 as annotated below).
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Ogra teaches using deuterium as a reaction gas in a collision cell for detecting selenium (Se) in samples containing bromine. Deuterium was proven to be effective is “dissociating polyatomic interferences and removing Br interferences during Se determination and speciation dissociating polyatomic interferences and removing Br interferences during Se determination and speciation (Ogra; abstract).” The results of the study show “severe interference of BrH+ with Se was reduced in the D2 reaction mode. Therefore, the D2 reaction mode provides more accurate results for Se detection in extracellular fluids.” Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device described in Mcalister to include the teachings of Ogra such that the collision cell, taught by Mcalister, is filled with deuterium gas. Doing so, is a more effective alternative to using H2 as a collision partner for dissociation.
Regarding claim 2, Mcalister teaches the analytical instrument of claim 1, wherein the analytical instrument comprises a mass spectrometer (fig. 1A as annotated below).
Regarding claim 3, Mcalister teaches the analytical instrument of claim 1, wherein the ion trap is quadrupole ion trap (fig. 1A as annotated below).
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Regarding claim 4, Mcalister teaches the analytical instrument of claim 1, wherein the ion trap is a mass analyzer (The mass analyzer 40, which may comprise a quadrupole ion trap (para. [0004])).
Regarding claim 5, Mcalister teaches the analytical instrument of claim 1, wherein the analytical instrument comprises a chromatography system in combination with a mass spectrometer (the sample inlet may be an outlet end of a chromatographic column, such as liquid or gas chromatograph (not depicted (para. [0003])).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Mcalister and Ogra, as applied to claim 1 above, and in further view of Hatanaka et al. (JPH0982273A), hereinafter referred to as “Hatanaka”.
Regarding claim 6, Mcalister does not explicitly teach wherein the gas is provided by a cylinder of deuterium gas.
However, Hatanaka teaches wherein the gas is provided by a cylinder of deuterium gas (gas cylinder 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device described in Mcalister such that the deuterium gas is stored in a cylindrical container in order to achieve the predictable result of safely storing the deuterium gas at high pressures.
Regarding claim 7, Mcalister does not explicitly teach wherein the gas is provided by a deuterium generator.
However, Hatanaka teaches wherein the gas is provided by a deuterium generator (Further, as a method for supplying deuterium, it is possible not only to easily control the amount of deuterium atoms generated by passing through a diffusion and permeation process in the Pd film, but also to reduce the mixing of impurity gas (para. [0020])).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device described in Mcalister to include a deuterium generator, taught by Hatanaka, to provide deuterium to the ion trap and/or collision cell.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mcalister in view of Ogra, as applied to claim 1 above, and in further view of Christie G. Enke et al. (US 4234791 A), hereinafter referred to as Enke.
Regarding claim 8, Mcalister does not explicitly teach the analytical instrument of claim 1, wherein the gas is provided at a pressure of at least 0.1 mTorr.
However, Enke teaches wherein the gas is provided at a pressure of at least 0.1 mTorr (A collision gas, which may be argon, is introduced into the quadrupole-type device at pressures up to 2.times.10.sup.-3 torr, or even higher (col. 6, lines 2-4)) (.002 Torr= 2 mTorr).
Optimizing the pressure of a collision gas in mass spectrometry is well within the bounds of normal experimentation. See MPEP 2144.05 II (A). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, “[a] particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation.” In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In the case at hand, Enke teaches that “The collection efficiency in the quadrupole CID region has been found experimentally to be virtually 100%. There is no detectable loss of ions due to scattering, neutralization, or similar mechanisms at pressures up to 2.times.10.sup.-4 torr (col. 12, lines 5-9)” . As such, Enke identifies gas pressure as a variable which achieves a recognized result, i.e., [minimizing the loss of ions due to scattering, neutralization, or similar mechanisms]. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective time of filing to optimize gas pressure in Mcalister, in view of Ogra, such that the gas (collision gas (Mcalister; para. [0005])), taught by Ogra to be Deuterium, is provided at atleast 0.1 mTorr, as taught by Enke, since it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.
Regarding claim 9, Mcalister fails to teach the analytical instrument of claim 8, wherein the gas is provided at a pressure of about 1 mTorr to about 10 mTorr.
However, Enke teaches wherein the gas is provided at a pressure of about 1 mTorr to about 10 mTorr (A collision gas, which may be argon, is introduced into the quadrupole-type device at pressures up to 2.times.10.sup.-3 torr, or even higher(col. 6, lines 2-4)) (.002 Torr= 2 mTorr).
See obviousness statement for claim 8 above.
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 10-11, 13, 17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Ogra.
Regarding claim 10, Ogra teaches a method of using a gas in an analytical instrument, the method comprising: using a deuterium gas as a primary gas in one or both of an ion trap or a collision cell gas (In this study, the utility of deuterium (D2) in place of H2 as a reaction gas was clarified (para. [0004])) (table 1 as annotated above).
Regarding claim 11, Ogra teaches the method of claim 10, further comprising using one or both of the ion trap or collision cell in a mass spectrometer (To this end, ICP-MS equipped with a reaction/collision cell was developed as an alternative technique to ICP with high-resolution MS, in order to overcome this problem posed by the polyatomic interferences (para. [0002])) in combination with a chromatography system (The ICP-MS was coupled to an HPLC system as the detector for the Se speciation (para. [0007])).
Regarding claim 13, Ogra teaches the method of claim 11, wherein the chromatography system is a liquid chromatography system (The ICP-MS was coupled to an HPLC system as the detector for the Se speciation (para. [0007])).
Regarding claim 17, Ogra teaches a method of mass spectrometry, the method comprising: generating first ions (the determination of Se in serum and urine samples in each reaction mode was conducted at m/z 77, 78, 80 and 82 (para. [0008])), wherein one or both of the ion trap or the collision cell is filled with a deuterium gas (Table 1 as annotated above);
and analysing the first ions or second ions derived from the first ions or both (Hence, the effects of D2 not only on the determination but also on the speciation of Se in ICP-MS were evaluated (para. [0004])).
Regarding claim 19, Ogra teaches the method of claim 17, wherein processing the first ions comprises fragmenting the first ions by colliding them with the deuterium gas to produce fragment ions, and the analysing comprises analysing the fragment ions ions (Thus, D2 was effective in dissociating polyatomic interferences and removing Br interferences during Se determination and speciation (abstract)) (In the D2 reaction mode, the interference was well dissociated at m/z 82, and the formation of 81Br2D+ was newly observed at m/z 83. 82Se1H+ and 82Se2D+ were detected at m/z 83 and 84, respectively (para. [0012])).
Regarding claim 20, Ogra teaches the method of claim 17, wherein processing the first ions comprises reacting the first ions with the deuterium gas (In this study, deuterium (D2) was evaluated for possible use as a reaction gas) to produce secondary ions, and the analysing comprises analysing the secondary ions ((Thus, D2 was effective in dissociating polyatomic interferences and removing Br interferences during Se determination and speciation (abstract)) (In the D2 reaction mode, the interference was well dissociated at m/z 82, and the formation of 81Br2D+ was newly observed at m/z 83. 82Se1H+ and 82Se2D+ were detected at m/z 83 and 84, respectively (para. [0012])).
Claims 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ogra in view of Mcalister.
Regarding claim 12, Ogra fails to teach the method of claim 11, wherein the chromatography system is a gas chromatography system
However, Mcalister teaches the method of claim 11, wherein the chromatography system is a gas chromatography system (such as liquid or gas chromatograph (not depicted), from which an eluate is supplied to the ion source (para. [0003])).
Both Mcalister and Ogra teach chromatograph systems in combination with mass spectrometer. Ogra teaches a liquid chromatograph in combination with a mass spectrometer. Mcalister teaches both a liquid or gas chromatograph in combination with a mass spectrometer. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method described in Ogra to include the teachings of Mcalister such that the chromatograph is a gas chromatograph. Doing so is a simple substitution of one known element for another to obtain predictable results because gas chromatography and liquid chromatography are both well-known ways to supply a sample to a mass spectrometer.
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ogra in view of Mcalister, as applied to claim 12 above, and in further view of Hatanaka.
Regarding claim 14, Ogra fails to teach the method of claim 12, further comprising providing the deuterium gas via a deuterium gas generator system or via a compressed cylinder of deuterium gas.
However, Hatanaka teaches further comprising providing the deuterium gas via a deuterium gas generator system or via a compressed cylinder of deuterium gas (deuterium gas cylinder 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device described in Ogra such that the deuterium gas is stored in a cylindrical container in order to achieve the predictable result of safely storing the deuterium gas at high pressures.
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ogra, as applied to claim 13 above, and in further view of Hatanaka.
Regarding claim 15, Ogra fails to teach the method of claim 13, further comprising providing the deuterium gas via a deuterium gas generator system or via a compressed cylinder of deuterium gas.
However, Hatanaka teaches, further comprising providing the deuterium gas via a deuterium gas generator system or via a compressed cylinder of deuterium gas (deuterium gas cylinder 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device described in Ogra such that the deuterium gas is stored in a cylindrical container in order to achieve the predictable result of safely storing the deuterium gas at high pressures.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ogra, as applied to claim 10 above, and in further view of Noriyuki Yamada (US 11443933), hereinafter referred to as Yamada.
Regarding claim 16, Ogra fails to teach the method of claim 10, wherein the ion trap is a quadrupole ion trap.
However, Yamada teaches wherein the ion trap is a quadrupole ion trap (That is, the ICP-MS system 200 includes three linear quadrupole devices arranged in series along the main ion optical axis: a first (or pre-LIT) linear quadrupole ion guide (Q1) 256, followed by a linear quadrupole ion trap (LIT) 212 (col. 14, lines 41-44)).
Ogra teaches the use of ICP-MS. Yamada teaches a quadrupole ion trap used in an ICP-MS system. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device described in Ogra, to incorporate the teachings of Yamada, by including a quadrupole ion trap. The incorporation of a quadrupole ion trap in an ICP-MS is applying a known technique to a known device to yield predictable results.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ogra, as applied to claim 17 above, and in further view of Melvin A. Park (US 20030042412), hereinafter referred to as Park.
Regarding claim 18, Ogra fails to teach the method of claim 17, wherein processing the first ions comprises collisionally cooling the first ions.
However, Park teaches wherein processing the first ions comprises collisionally cooling the first ions (More specifically, a first multipole (preferably a quadrupole) is used to select precursor ions, the ions are allowed to collide with a collision surface, and the fragment ions thereby produced are collisionally cooled in a second multipole and then mass analyzed in a mass analyzer (preferably a TOF mass analyzer (para. [0039])).
Both Ogra and Park teach collision cells. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device described in Ogra to include the teachings of Park such that the first ions (serum), in Ogra, are collisionally cooled. Doing so produces the predictable result to one of ordinary skill in the art of obtaining “a higher resolution mass spectrum (Park; para. [0010])”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICA J. EINHORN whose telephone number is (571)272-4641. The examiner can normally be reached Mon-Fri. 7:30am-5pm. 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, Robert Kim can be reached at (571) 272-2293. 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.
/MICA JILLIAN EINHORN/Examiner, Art Unit 2881
/WYATT A STOFFA/Primary Examiner, Art Unit 2881