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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/19/2024 has been considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the ion detector of claim 19, the amplifier of claim 19, and the control circuitry of claim 21 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. In particular, these claims recite a “circuit” that is not disclosed in any of the drawing. Applicant provides neither schematic nor written description of an actual electrical circuit. The disclosure of an electrical circuit apparatus, depicted in the drawings by block diagrams with functional labels is non-enabling. MPEP § 2164.06(a)(I) citing, In re Gunn, 537 F.2d 1123, 1129, 190 USPQ 402, 406 (CCPA 1976).
Note MPEP § 2164 stating:
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is “reasonable” or is “undue.”
Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. See Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024). These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
As applied to the instant claim 21, the device recited claims a mass spectrometer and control circuity, thereby encompassing any mass spectrometer and the non-enabled control circuit. This weighs against enablement given the ubiquity of mass spectrometers and any potential circuit one could affix to the spectrometer.
The nature of the invention is a mass spectrometer for the analysis of ions having a particular control circuit which is non-enabled. This weighs against enablement because mass spectrometers may be controlled with numerous conventional means and the lack of an enabling disclosure regarding the control means for carrying out the invention requires undue experimentation.
The state of the prior art and the attached prior art shows that mass spectrometers with assorted control means ranging from generic control circuits, specialized computer and combinations of these are conventional in the prior art. This weighs against enablement since it is the function of the non-enabled control circuit which the claim relies upon to establish patentability.
One of ordinary skill in the art would be able to construct a circuit using conventional components. The amount of time and experimentation needed to build a circuit to accomplish the circuit claimed by the Applicant in claim 21 is not clear since there is no disclosure of the detail of the circuit.
The level of the art is highly predictable since mass spectrometry and related methods of data handling are conventional.
The disclosure lacks guidance regarding the control circuit and also lacks an example of the circuit.
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.
Claim(s) 1, 5, 6, 20, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US Patent Application Publication 2009/0057547.
Regarding claim 1, ‘547 discloses a method comprising mass analyzing ions to produce first mass spectral data
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Note [0013] above indicating at least a first set of spectral data is acquired. The indicated bins are periods of time, thus providing at least one integration period.
Also note above indicating the data acquired is summed at [0014].
A transmission profile is obtained by obtaining a Poisson distribution, note {0108]. Since the disclosure notes that the transmission profile may come from any source including merely being known, ‘547 satisfies this step.
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Preceding paragraphs show further detail regarding this transmission profile, i.e. the ion arrival distribution.
The ion arrival rate is then determined using the transmission profile. The Poisson distribution is used in part to correct the arrival rate in the at least one or more bins (time periods), thus the ion arrival rate is determined.
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Regarding claims 5 and 20, as noted above the determined ion arrival rate is explicitly adjusted or corrected for the mass spectral data collected, as noted above in [0109].
Regarding claim 6, note above in [0013] indicating plural cycles are run to acquire the noted plural sets of mass spectral data.
Regarding claim 21, ‘547 discloses an apparatus for carrying out the method of claim 1 comprising a mass analyzer and a processing system. Note [0026-0031]. The processing system of ‘547 appears to be a generic control or processing circuit, and since the method of claim 1 is captured in the function of claim 21, and the prior art of ‘547 discloses a similarly vague structure for executing the method, ‘547 appears to anticipate claim 21.
Allowable Subject Matter
Claims 2-4, 7-12, and 14-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2, the prior art fails to teach or suggest the method of claim 1 comprising determining an intensity in the summed mass spectral data of said first ions having a selected mass to charge ratio; wherein said step of determining an ion arrival rate comprises determining the ion arrival rate of said first ions at the mass analyzer as a function of time during the first integration period based on said intensity and said transmission profile.
Regarding claims 3-4 and 14-19, the prior art, particularly ‘547 does not additionally teach controlling the mass spectrometer based on the determined ion arrival rate, i.e. the result achieved in claim 1. ‘547 in particular stops with the adjustment or correction of deadtime effects in ion arrival rate.
Regarding claims 7-12, the prior art fails to teach or suggest the method of claim 1 comprising varying the operation of one or more ion-optical devices arranged upstream of the mass analyzer with time according to a scan function during each of the first and/or second integration period such that said first ions, or parent ions of said first ions, are transmitted by the one or more ion-optical devices with an intensity that varies as a function of time within each of the first and/or second integration period.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Georgia EPPS can be reached at (571) 272-2328. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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DAVID A. VANORE
Primary Examiner
Art Unit 2881
/DAVID A VANORE/ Primary Examiner, Art Unit 2878