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 3/18/24; 9/13/24; 3/26/25; and 9/30/25 have been considered by the examiner.
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.
Claim(s) 1-6, 8-12, 15-16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over USPN 2008/0296490 A1 in view of USPN 2009/0266983 A1.
Regarding claim 1, ‘490 discloses a method of mass spectrometry where a user, or “one” may select and thereby set one or more target m/z ranges [0042]. The sample is then subjected to the analysis process of where ions are generated by ionization of a sample and subsequent analysis in a TOF mass analysis apparatus comprising an ion source, accelerator, and TOF mass analyzer [0029]. Subsequent ion generation and detection, the method of ‘490 then integrates, or sums, the ion counts with the one or more target m/z ranges and stores them, implicitly thereby not storing data outside the target mass range [0042].
‘490 does not disclose the fragmentation step noted in claim 1.
‘983 discloses a mass analysis system and method where ions are generated by inputting a mass scan or m/z range via input device 44, introducing a sample to a mass analysis apparatus by an ionization means (22), fragmenting ions via a collision cell (Item 29,30), and accelerating fragmented ions prior to detection in a TOF mass spectrometer (31-33). The apparatus including an analysis controller, central controller, and data processor being embodied as a personal computer which inherently has a memory means as well. [0039] in ‘983.
‘983 modifies ‘490 to provide an apparatus and method for producing detected ions which are the product of fragmenting precursor sample ions prior to detection.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the apparatus to produce ions for analysis by the method of ‘490 since providing fragmented precursor ions prior to analysis is conventional in the art of mass spectrometry.
Regarding claim 8, as noted above, the apparatus of ‘983 includes an ionization device (22), a dissociation device (29,30), a mass analyzer including a TOF analyzer (32) and detector (33) additionally comprising an input device, processor, and memory [0039, personal computer]. This apparatus contains all the elements to perform the method recited in claim 1 and the rationale for obviousness is similarly appliable to claim 8.
Regarding claim 15, claim 15 is substantially similar to claim 1 and differs by requiring the setting of plural m/z ranges and separate summing and storing steps for the additional m/z ranges. As noted above in claim 1, ‘490 discloses setting plural m/z ranges, and integrating and storing the respective ion counts for those ranges [0042]. As with claim 1, ‘490 lacks the required fragmentation step, hence the combination with ‘983 and accompanying rationale for obviousness made of record with respect to claim 1 is similarly applicable to claim 15.
Regarding claims 2, 9, and 16, ‘490 discloses at [0037-0038] and in Fig. 2 that the respective analyte concentrations, or amounts via their abundance, are calculated for a sample based on their relative abundance which is illustrated for plural analytes in Fig. 2 represented by 32 and 33 respectively.
Regarding claim 3, ‘490 as noted above performs detection via a TOF analyzer.
Regarding claim 4, ‘490 as noted above sets one or more m/z ranges, integrates or sums the ion counts in each range and stores the summed counts [0042].
Regarding claim 5, ‘490 teaches that the characteristic relied upon for performing data selection and analysis is determined from detected data [0049] thus setting targe m/z ratios at least in part based on detected data reflecting ion abundance reflective of analyte concentration.
Regarding claim 6, ‘490 additionally teaches selecting a characteristic for data analysis and thereby the setting of target m/z range based on a particular peak of interest reflecting an isotopic cluster [0045].
Regarding claim 10, ‘490 states the one may select one or more additional m/z ranges input from for example computer 9. A computer inherently has or comprises an input device thereby enabling the input of additional m/z ranges.
Regarding claims 11-12, ‘490 discloses an additional quadruple filter for filtering ions as desired [0018].
Regarding claim 20, ‘490 discloses that the detection is performed with a TOF mass analyzer as noted above.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the judicial exception of mathematical calculation. Claims 1, 8, and 15, recite a method and apparatus which may each be decomposed into a data generation component and a mathematical calculation component. In claims 1, 8, and 15, a conventional prior art mass spectrometry apparatus is employed to practice a process of mass analysis. Ions are generated from a sample, passed through a collision or fragmentation cell, a quadrupole, and accelerated into a Time of Flight mass spectrometer and detected. The prior art cited above each contain devices which encompass these prior art structures and process steps for generating data. Subsequently, the data so generated is subjected to the mathematical functions of summing (integrating) and storage (archiving).
For example, in claims 1 and 8, the prior art noted above recites all the required structure for performing the data generation including the ionization, fragmentation, analysis, and detection steps. The prior art similarly anticipates setting plural m/z ranges for analysis. The subsequent steps of summing or adding the collected data and archiving or storing data are mere mathematical calculation steps since summing is addition and storing is merely retaining data already possessed.
Subsequent claims perform additional calculation or conversion steps where data is operated on to convert it from one form to another via mathematical algorithm. Consequently, the totality of the invention expressed in the independent claims and subsequent dependent claims merely employs a prior art apparatus as a tool to generate data and then perform mathematical calculation on the result of the data so generated.
This judicial exception is not integrated into a practical application because the analysis of the claims in view of MPEP 2164.04(d) does not show nor is there evidence that the claimed invention improves the function of a computer. Similarly, there is no evidence of application to effect treatment or prophylaxis. The machine relied upon is not particular as evidenced by the structure corresponding to prior art structures. The judicial exception is not employed to effect a transformation or reduction of one thing to another since the end point of each of the claims concludes with the performance of mathematical calculation. As a whole, there is no practical application because the mathematical calculation is merely used in the particular technical environment claimed.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed invention merely uses a prior art mass spectrometer device as a tool to generate data upon which mathematical calculations are performed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A VANORE whose telephone number is (571)272-2483. The examiner can normally be reached Monday to Friday 7AM to 6 PM.
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DAVID A. VANORE
Primary Examiner
Art Unit 2881
/DAVID A VANORE/Primary Examiner, Art Unit 2878