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 .
Status
Claims 1-8 are pending
Claims 9-20 are withdrawn.
Claim Interpretation
Claim 1 is amended to require that a time period between ejections of a first and second be based on predicted sample intensities. This limitation is understood to require that a delay time between ejections be linking to the predicted intensities, but is not understood to require any particular calculation.
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 7 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 7 recites, “wherein the first sample intensity signal is indicative of a first concentration of the first sample in the first well of the well plate and the second sample intensity signal is indicative of a second concentration of the second sample in the second well of the well plate.” Neither “the first sample intensity signal” nor “the second sample intensity signal” has antecedent basis in the claims. Further, it is unclear whether these limitations are related to mass spectra generated presumably generated in claim 2, or to the predictions of claim 1. As such, the claim is indefinite.
Claim 8 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 8 recites, “the first sample intensity signal” and “the mass spectrometry device.” Neither limitation has antecedent basis in the claims. Further, it is unclear whether these limitations are related to mass spectra generated presumably generated in claim 2, or to the predictions of claim 1. As such, the claim is indefinite.
Claims 1-8 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. If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993). Claim 1 requires that “wherein a time period between the acoustic ejection of the first sample and the acoustic ejection of the second sample is based at least in part on the first sample intensity prediction and the second sample intensity prediction.” However, there is no time period calculation step or input step. Rather, there is simply a time period. One of practicing prior art acoustic ejection mass spectrometry would have no way of knowing whether or not his ejections infringed upon the instant claims, because the determination of whether the time period is based on predicted intensities could be made ex post facto. That is to say, a practitioner could arrive at a precise delay time of 5 seconds between ejections simply because of the lab operating procedures, i.e., a reason entirely unrelated to sample intensity prediction. However, if that time period, i.e. 5 seconds, is also a number that could be based upon predicted intensities, then the practitioner would be infringing upon the claim. Since one of ordinary skill in the art cannot interpret the metes and bounds of the claim so as to understand how to avoid infringement, the claim is indefinite.
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Van Berkel, Gary J., Vilmos Kertesz, and Harry Boeltz. "Immediate drop on demand technology (I-DOT) coupled with mass spectrometry via an open port sampling interface." Bioanalysis 9.21 (2017): 1667-1679 [hereinafter Van Berkel]
Regarding Claim 1:
Van Berkel discloses a method of ejecting a plurality of samples from a well plate (abstract), the method comprising:
receiving a first sample intensity prediction (pg 1674, first paragraph predicts peak shapes, which is an intensity prediction at least in that it predicts the intensity over time) associated with a first sample in a first well of the well plate (pg 1674, third paragraph – 125 nM reserpine);
receiving a second sample intensity prediction (pg 1674, first paragraph predicts peak shapes, which is an intensity prediction) associated with a second sample in a second well of the well plate (pg 1674, third paragraph – 62.5 nM propranolol);
acoustically ejecting the first sample from the first well (Fig. 5 demonstrates an ion current chromatogram showing reserpine measurements after ejection) ; and
after acoustically ejecting the first sample, acoustically ejecting the second sample from the second well (Fig. 5 demonstrates an ion current chromatogram showing propranolol measurements after ejection and after at least some reserpine ejections),
wherein a time period between the acoustic ejection of the first sample and the acoustic ejection of the second sample (pg 1674, third paragraph -5 s) is optimized to improve signal by eliminating interference (pg 1674, first and second paragraphs).
However, Van Berkel does not explicitly teach that the time period between ejections is based at least in part on the first sample intensity prediction and the second sample intensity prediction. Rather, Van Berkel teaches that the time between planned pulses is chosen to control the infusion signal, as low times result in significant peak overlap and interference. (pg 1674, first paragraph). It would have been obvious to one of ordinary skill in the art before the effective time of filing to use the above noted teaching of Van Berkel regarding separating signals to eliminate interference to modify the planned multi-well sampling taught therein, so that ejection time delay is based at least in part on the first and second sample intensity predictions, since this would allow one to optimally control peak overlap therein.
Regarding Claim 2:
Van Berkel teaches the method of claim 1, further comprising receiving the well plate in a mass spectrometry device (See Fig. 2C).
Regarding Claim 3:
Van Berkel teaches the method of claim 1, further comprising calculating an adjusted time period, wherein the adjusted time period is based at least in part on a reference time period and the ejection delay time value (pg 1674, first paragraph).
Regarding Claim 4:
Van Berkel teaches the method of claim 3, wherein acoustically ejecting the second sample is performed after the adjusted time period elapses (See Fig. 5 and pg 1674, third paragraph).
Regarding Claim 5:
Van Berkel teaches the method of claim 1, further comprising:
receiving a third sample intensity prediction of a third sample intensity signal associated with a third sample in a third well of the well plate, wherein the third sample intensity prediction is at least one of greater than and equal to the second sample intensity prediction (Fig. 5, the third well is another well of 125 nM reserpine).
Regarding Claim 6:
Van Berkel teaches the method of claim 5, further comprising after acoustically ejecting the second sample, acoustically ejecting the third sample from the third well, wherein ejecting the third sample is performed after the reference time period elapses (Fig. 5 – this corresponds to third or later ejections of reserpine).
Regarding Claim 7:
Van Berkel teaches the method of claim 1, wherein the first sample intensity signal is indicative of a first concentration of the first sample in the first well of the well plate and the second sample intensity signal is indicative of a second concentration of the second sample in the second well of the well plate
Regarding Claim 8:
Van Berkel teaches the method of claim 1, further comprising storing, in a memory coupled to the mass spectrometry device, the first sample intensity prediction with the first sample intensity signal. Associating the measurements with the wells in a computer is evident from the digital graphs provided in the references.
Response to Arguments
Applicant's arguments filed 12/8/25 have been fully considered but they are not fully persuasive.
Applicant’s arguments and amendments have overcome the 35 USC 112(b) rejections of the previous office action.
Applicant argues that Van Berkel fails to teach a dynamic ejection time, and as such cannot anticipate or render obvious the instant claims. In response to applicant's argument that the references fail to show dynamic ejection times, it is noted that dynamic ejection times are not recited in the rejected claim(s). 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). The fixed time delay of Van Berkel at least suggests the actual claims since the fixed delays are based on predictions of ion intensities at the edges of peaks.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WYATT A STOFFA whose telephone number is (571)270-1782. The examiner can normally be reached M-F 0700-1600 EST.
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WYATT STOFFA
Primary Examiner
Art Unit 2881
/WYATT A STOFFA/Primary Examiner, Art Unit 2881