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 Amendment
The preliminary amendments filed 12/08/2023 have been entered. Claims 10-11 have been canceled. Claims 1-9 and 12-20 are now pending in the application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
item 102 in Fig. 2A;
item 702a in Fig. 4;
item 400e in Fig. 5.
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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
In Fig. 3, item 216;
In Fig. 4, item 705.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “214” in Fig. 2A has been used to designate both a region indicated by a dashed line which corresponds to the described sampling space and the connecting conduit;
Reference character “104b” in Fig. 2B has been used to designate both inlets to the fluidic junction 104, where the leftmost item labeled as 104b should be labeled as 104a.
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. 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.
The drawings are objected to because:
In Fig. 2A, item 104b does not point to the inlet of fluidic junction 104 that is coupled to reservoir 107;
In Fig. 2A, 104a and 104 each point to arrows which indicate flow, while 104a and 104 are described in the specification as “inlet of the fluidic junction” and “the fluidic function”, respectively;
Fig. 2A refers to item 210b as ‘Sample capture and dilution region 210b’ and points to a dashed line which appears to show flow, while the specification refers to 210b as ‘an outlet end of the liquid supply conduit’;
Fig. 2A shows a rectangular dashed area labeled with ‘Calibrant pump’, however, the specification does not refer to the dashed area whatsoever, and the calibrant pump is discussed in the specification as being item 109;
Fig. 3 shows reference number 100 referring to ‘Calibrant pump’, which also points to a rectangular dashed region which is not described in the specification; The specification refers to item 100 previously as ‘a system’ and as ‘the calibration/tuning system’ (see p. 15) and the calibrant pump as item 109;
Fig. 3 indicates item 216 as being different from that which is shown in previous figures (i.e., the ESI source in Fig. 2A), and is not described in reference to Fig. 3 in the specification;
Fig. 4 indicates that item 700 is ‘calibration solution’, while the specification indicates 701a is the calibration solution, and 700 as referring to ‘a calibration/tuning system’ (see p. 16-17);
The description of Fig. 4 indicates that the ‘sampling probe’ is item 702, but item 702 appears to indicate another item in the figure (i.e., part of the fluid flow path; see p. 16);
In Fig. 4, item 703 points to an arrow which indicates a flow, while 703 is described in the specification as “fluidic junction”;
Fig. 4 shows a second pumping apparatus and fluid inlet which are not labeled in the figure and not described in the specification, and appears to show additional inlets on both pumping arrangements which are not labeled or described in the specification.
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.
Specification
The disclosure is objected to because of the following informalities:
The description (see p. 13, paragraph 2) refers to both the liquid exhaust conduit and the electrically conductive capillary as item 212; it appears that the electrically conductive capillary should be referred to by reference number 218 (this reference number is previously used for this item in the same paragraph);
The description (see p. 13, final paragraph), the specification recites “With continued reference to FIG. 1…”, which appears should refer to Fig. 2A;
The description (p. 14, paragraph 2) disagrees with Fig. 2A and the previous description in that it indicates inlet 104a as carrying the calibration solution from reservoir 108 via action of pump 109, however, the calibration solution reservoir 108 is previously indicated as being coupled to inlet 104b; This portion also indicates the transport liquid being introduced into the junction via inlet 104b by action of pump 110, but previous description indicates that the transport liquid enters the junction via inlet 104a.
Appropriate correction is required.
Claim Objections
Claims 12 and 19 are objected to because of the following informalities:
Claim 12 recites “…said fluidic junction further having an inlet in fluid communication with said first and second inlets and further configured for fluid communication with said OPI for introducing any of said transport liquid, said calibration liquid and a mixture thereof into said OPI…”, which should read ‘…said fluidic junction further having an inlet in fluid communication with said first and second inlets and further configured for fluid communication with said OPI for introducing any of said transport liquid, said calibration liquid, and a mixture thereof into said OPI…’ to ensure ‘a mixture thereof’ clearly indicates ‘a mixture of said transport liquid and said calibration liquid’, as the lack of a comma could make the meaning ambiguous;
Claim 19 recites “…said ion source comprise an ESI source…”, which should read ‘…said ion source comprises an ESI source…’;
Claim 19 recites “…said one or more mass analyzers comprise any of a time-of-flight (TOF) mass analyzer, a quadrupole mass analyzer and a combination thereof…”, which should read ‘…said one or more mass analyzers comprise any of a time-of-flight (TOF) mass analyzer, a quadrupole mass analyzer, and a combination thereof…’ to ensure ‘a combination thereof’ clearly indicates ‘a combination of said TOF mass analyzer and said quadrupole mass analyzer’, as the lack of a comma could make the meaning ambiguous.
Appropriate correction is required.
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.
Claims 1-9 and 12-20 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.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: ‘a controller operably coupled to said second pump for controlling said second pump’. While Applicant’s disclosure has not explicitly indicated such an element as essential, there is no other disclosed means by which the second pump can be controlled to perform its necessary function, i.e., to cause a flow of the transfer liquid from the second reservoir into the second inlet. Were such an element not present, the invention would be unsuitable for its intended purpose, as the second pump would not have the capability to control the flow of the transfer liquid into the fluidic junction and the primary function of ‘calibration’ could not be performed by the ‘calibration system’. Based on the whole of Applicant’s disclosure, the control of the flow of both the calibration liquid and transfer liquid are implicitly necessary to have the proper flow to the fluidic junction such that the amount of fluid reaching an air/liquid interface of the OPI is controlled to desired quantities. Furthermore, the specification indicates that the flow of the transfer liquid is implicitly necessary in order for the mixed fluids to reach downstream elements. Accordingly, the claim is rendered indefinite and rejected for omitting essential elements. For purposes of examination, this claim is interpreted as including the limitation is interpreted as ‘the controller operably coupled to said second pump for controlling said second pump’.
Claim 2 recites “…further comprising a second pump operably coupled to said second reservoir for causing flow of the transport liquid from said second reservoir into said second inlet of the fluidic junction…”, however, claim 2 depends on claim 1, which already requires “a second pump operably coupled to said second reservoir for causing a flow of the transport liquid from said second reservoir into said second inlet” and “a fluidic junction having…a second inlet in fluid communication with a second reservoir containing a transport liquid”. Accordingly, it is unclear whether this limitation in claim 2 is intended to require an additional ‘second’ pump that is coupled to the same elements as that which is required by claim 1. As such, it is not possible to adequately determine the metes and bounds of the claim, rendering it indefinite. For purposes of examination, this limitation is interpreted as being omitted so as not to repeat a limitation that is already required by the claim.
Claims 3 recites “…wherein said controller is configured to adjust a speed of said second pump so as to reduce the flowrate of the transport liquid…”. It is unclear whether ‘a speed’ is intended to refer to the same speed as that recited in claim 2 (i.e., ‘a pumping speed’), or some other form of speed that is not related to ‘pumping’. Additionally, because claim 2 has an indefiniteness issue with regards to ‘the second pump’ as discussed above, it is unclear whether the recitation of ‘said second pump’ is intended to refer to the pump of claim 2 or the pump of claim 1. As such, it is not possible to adequately determine the metes and bounds of the claim, rendering it indefinite. For purposes of examination, this limitation is interpreted as ‘…wherein said controller is configured to adjust the pumping speed of said second pump so as to reduce the flowrate of the transport liquid…’, wherein the adoption of the above interpretation for claim 2 ameliorates the issue regarding ‘said second pump’ in claim 3.
Claims 4 recites “…wherein said controller is configured to adjust the speed of the second pump so as to reduce the flowrate of the transport liquid…”. It is unclear whether ‘the speed’ is intended to refer to the same speed as that recited in claim 2 (i.e., ‘a pumping speed’), or some other form of speed that is not related to ‘pumping’. Additionally, because claim 2 has an indefiniteness issue with regards to ‘the second pump’ as discussed above, it is unclear whether the recitation of ‘said second pump’ is intended to refer to the pump of claim 2 or the pump of claim 1. As such, it is not possible to adequately determine the metes and bounds of the claim, rendering it indefinite. For purposes of examination, this limitation is interpreted as ‘…wherein said controller is configured to adjust the pumping speed of the second pump so as to reduce the flowrate of the transport liquid…’, wherein the adoption of the above interpretation for claim 2 ameliorates the issue regarding ‘said second pump’ in claim 4.
Claim 5 recites the limitation "the flowrate". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this limitation is interpreted as ‘a flowrate’.
Claims 7-8 recite the limitation "the flowrate of said transport liquid". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this limitation is interpreted as ‘a flowrate of said transport liquid’.
Claim 9 recites the limitation "the flowrate of the transport liquid". There is insufficient antecedent basis for this limitation in the claim. However, Examiner notes that were the issue in claim 8 ameliorated, this issue would also be ameliorated, and as such this claim is interpreted as presented by Applicant in view of the interpretation adopted for claim 8.
Claim 9 recites “…wherein said controller is configured to adjust the flowrate of the transport liquid so as to maintain a flowrate of liquid into the OPI at a substantially constant level.”, however, it is unclear how changing a flow rate of the transfer liquid can possibly maintain a flowrate of liquid (interpreted as any/all liquid) into the OPI at a constant level, as the flowrate of liquid at the OPI would necessarily depend on the flowrate of the transfer liquid. Accordingly, adjusting the flowrate of the transport liquid alone would necessarily change the flowrate of liquid into the OPI, meaning that the flowrate of liquid into the OPI would not be constant. Based on Examiner’s reading of Applicant’s specification, it appears the only disclosed way to maintain a substantially constant flowrate of liquid into the OPI would be to control the flowrates of both the transport liquid and the calibration liquid such that increasing the flowrate of one would be compensated by decreasing the flowrate of the other (and vice versa). As such, it is not possible to adequately determine the metes and bounds of the claim, rendering it indefinite. For purposes of examination, this limitation is interpreted as ‘…wherein said controller is configured to adjust both the flowrate of the transport liquid and a flowrate of the calibration liquid, so as to maintain a flowrate of liquid into the OPI at a substantially constant level.’
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the basic elements that make up a mass spectrometer (i.e., sample source(s), ionizer(s), mass separator(s), mass analyzer(s), etc.). The claim is nominally directed toward ‘a mass spectrometer’, however, the claim requires none of the elements that one of ordinary skill in the art would understand to be necessary to a mass spectrometer, and appears to require elements that would amount to a fluid handling system. It appears that claim 19 contains elements that an ordinarily skilled artisan would understand as constituent elements of a mass spectrometer, however, none of claims 13-18 recite elements that pertain to a mass spectrometer and not a fluid handling system. Additionally, the required elements of claim 12 also appear to lack all of the necessary elements to such a fluid handling system as disclosed by Applicant’s specification. For instance, Applicant’s specification discloses no means by which transport liquid is introduced into the fluidic junction except by controllably pumping. Accordingly, the claim is additionally rejected for omitting essential elements for similar reasons to claim 1. As such, it is not possible to adequately determine the metes and bounds of the claim, rendering it indefinite. For purposes of examination, the claim is interpreted as reciting ‘A fluid handling system, comprising...’ in place of “A mass spectrometer, comprising…”, and is interpreted as additionally reciting ‘a second pump operably coupled to said second reservoir for causing a flow of the transport liquid into said fluidic junction’ and ‘the controller operably coupled to said second pump for controlling operation thereof’.
Claim 12 recites “A mass spectrometer, comprising: an open port interface (OPI) for receiving a sample, a first reservoir for storing a calibration liquid, a second reservoir for storing a transport liquid, a fluidic junction having a first inlet configured for fluid coupling with said first reservoir for receiving the transport liquid and a second inlet configured for fluid coupling with said second reservoir for receiving said calibration liquid…” (Emphases added by Examiner). As can be seen by the underlined elements, the claim first states that the first reservoir stores the calibration liquid, and subsequently states that a first inlet is configured for fluid coupling with the first reservoir for receiving the transport liquid. However, it is unclear how coupling to the first reservoir can allow receiving the transport liquid, which is stored in the second reservoir. A similar issue is present regarding the second reservoir and the calibration liquid, as the second reservoir does not store the calibration liquid. As such, it is not possible to adequately determine the metes and bounds of the claim, rendering it indefinite. For purposes of examination, this limitation is interpreted as ‘A [fluid handling system], comprising: an open port interface (OPI) for receiving a sample, a first reservoir for storing a calibration liquid, a second reservoir for storing a transport liquid, a fluidic junction having a first inlet configured for fluid coupling with said first reservoir for receiving the calibration liquid and a second inlet configured for fluid coupling with said second reservoir for receiving said transport liquid…’.
Claim 12 recites “said fluidic junction further having an inlet in fluid communication with said first and second inlets and further configured for fluid communication with said OPI for introducing any of said transport liquid, said calibration liquid and a mixture thereof into said OPI”. It is unclear how the fluidic junction can have an additional inlet that is in fluid communication with the first and second inlets and also in fluid communication with the OPI. As such, it is not possible to adequately determine the metes and bounds of the claim, rendering it indefinite. Based on Examiner’s reading of Applicant’s disclosure, it appears this is intended to refer to an outlet of the fluidic junction rather than an additional ‘inlet’. For purposes of examination, this limitation is interpreted as ‘said fluidic junction further having an outlet in fluid communication with said first and second inlets and further configured for fluid communication with said OPI for introducing any of said transport liquid, said calibration liquid and a mixture thereof into said OPI’.
Claim 13 recites “…for calibrating said mass spectrometer.”, however, as discussed above, claim 12 does not properly require the elements of a mass spectrometer, and is thus interpreted as a fluid handling system. Thus, under the interpretation adopted ‘said mass spectrometer’ lacks antecedent basis. To avoid this issue, for purposes of examination, this limitation is interpreted as ‘…for calibrating a mass spectrometer coupled to the fluid handling system’.
Claim 14 recites “…further comprising a second pump operably coupled to said second reservoir for causing a flow of the transport liquid into said fluidic junction, wherein said controller is operably coupled to said second pump for controlling operation thereof.” However, claim 14 depends on claim 12, which is interpreted (see above) as requiring these elements. Accordingly, under the interpretation adopted claim 14 recites repeated limitations, and thus the claim is interpreted as omitted so as not to have a non-limiting claim. Claim 15 depends on claim 14, and is thus interpreted as depending on claim 12.
Claim 15 recites the limitation "the flowrate of the transport liquid". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this limitation is interpreted as ‘a flowrate of the transport liquid’.
Claim 15 recites “…(2) to reduce the speed of said second pump prior to activating said first pump for reducing the flowrate of said transport liquid into said OPI so as to inhibit an overflow of a mixture of the transport liquid and the calibration liquid at a liquid/air interface of said OPI…”. The wording of ‘to reduce the speed of said second pump prior to activating said first pump for reducing the flowrate of said transport liquid into said OPI’ is ambiguous, as it is not clear what ‘for reducing the flowrate of said transport liquid into said OPI’ is intended to point to (i.e., the first or second pump). As such, it is not possible to adequately determine the metes and bounds of the claim, rendering it indefinite. For purposes of examination, this limitation is interpreted as ‘…(2) prior to activating said first pump, to reduce the speed of said second pump for reducing the flowrate of said transport liquid into said OPI so as to inhibit an overflow of a mixture of the transport liquid and the calibration liquid at a liquid/air interface of said OPI…’.
Claim 18 recites the limitations "said sampling space", "said inlet", and "the/said inner conduit". There is insufficient antecedent basis for these limitations in the claim. For purposes of examination, this claim is interpreted as though claim 17 depends on claim 16, such that the terms have proper antecedent basis by dependency on claim 16 through claim 17.
Claim 19 recites the limitations "the/said inner conduit". There is insufficient antecedent basis for these limitations in the claim. For purposes of examination, this claim is interpreted as though claim 17 depends on claim 16, such that the terms have proper antecedent basis by dependency on claim 16 through claims 17 and 18.
Claim 19 recites the limitation "the received sample". There is insufficient antecedent basis for this limitation in the claim, as only a portion of the sample is required to be ‘received’ (i.e., the ion source is disclosed as ‘receiving at least a portion of the sample’). Accordingly, for purposes of examination, this claim is interpreted as ‘the received portion of the sample’.
Claim 19 recites “…and ionizing at least a portion of the received sample…”, however, based on the present wording, it is unclear what element of the claim this recitation is intended to limit. As such, it is not possible to adequately determine the metes and bounds of the claim, rendering it indefinite. For purposes of examination, this limitation is interpreted as ‘and wherein the ion source is configured for ionizing at least a portion of the received sample…’.
Claim 19 recites “…and further comprising one or more mass analyzers…”, however, based on the present wording, it is unclear what element of the claim this recitation is intended to limit. As such, it is not possible to adequately determine the metes and bounds of the claim, rendering it indefinite. For purposes of examination, this limitation is interpreted as ‘; the system further comprising one or more mass analyzers…’.
Claim 19 recites “…one or more mass analyzers for receiving at least a portion of said plurality of ions and generating a mass spectrum thereof…”. The wording used makes it unclear whether a method step is intended to be required, i.e., ‘and generating’. As such, it is not possible to adequately determine the metes and bounds of the claim, rendering it indefinite. For purposes of examination, this limitation is interpreted as ‘…one or more mass analyzers for receiving at least a portion of said plurality of ions and for generating a mass spectrum thereof…’, so as to ensure no method steps are required.
Claim 19 requires conventional elements of a mass spectrometer (e.g., ion source, one or more mass analyzers). However, under the adopted interpretation (i.e., because claim 12 does not properly recite any elements which would normally be understood as necessary for a mass spectrometer), the claim pertains to a fluid handling system as best understood, and it is unclear how the elements of a mass spectrometer further limit such a fluid handling system, as these elements appear to be those of an apparatus for use with the fluid handling system, rather than actual elements of the fluid handling system. Accordingly, it is not possible to adequately determine the metes and bounds of the claim, rendering it indefinite. For purposes of examination, the limitations pertaining to the mass spectrometer elements alone are interpreted as not required, and only the relative positioning of the elements of the fluid handling system necessary to use the fluid handling system with an arbitrary mass spectrometer having an ion source and one or more mass analyzers is required (i.e., the outlet of the inner conduit is configured to be positioned upstream of an ion source of a mass spectrometer). Alternatively, if Applicant intends to maintain claim 12 as ‘a mass spectrometer’, these essential mass spectrometer elements (i.e., an ion source and one or more mass analyzers) must be claimed in claim 12, and claim 19 should be correspondingly amended to reflect this change.
Claim 20 recites “A method of calibrating a mass spectrometer having an OPI for receiving a sample”, however, the claim does not recite any method steps that would be understood by an ordinarily skilled artisan as ‘calibrating’. For instance, the claim requires only requires introducing two liquids into a fluidic junction for introduction into the OPI, and does not require any step of measuring mass spectra or adjusting parameters of a mass spectrometer to calibrate the mass spectrometer. As such, it is not possible to adequately determine the metes and bounds of the claim, rendering it indefinite. For purposes of examination, this limitation is interpreted as ‘A method of introducing fluids into a mass spectrometer having an OPI for receiving a sample’.
Claims that depend on the above rejected claims are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
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.
Claims 1-5, 8-9, 12-13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Covey (U.S. PGPub. No. US 20210121905 A1).
Examiner notes that Covey is Applicant provided prior art via the IDS dated 12/08/2023.
Regarding claim 1, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey teaches a calibration system for use in a mass spectrometer having an open port interface (OPI) for receiving a sample for analysis (Abstract; [0001]; [0008]; [0026]), comprising:
a fluidic junction having (See Fig. 2, leftmost elements of figure, having a reservoir connected to an inlet of a junction; See annotated Fig. below, where left circle is inlet and right circle is junction; [0130]-[0135]),
a (See Fig. 2, pump shown on leftmost portion of figure; [0130]-[0135]), and
a controller
[the controller operably coupled to said .
PNG
media_image1.png
450
350
media_image1.png
Greyscale
Covey does not explicitly teach a fluidic junction having a first inlet in fluid communication with a first reservoir containing a calibration liquid and a second inlet in fluid communication with a second reservoir containing a transport liquid, said fluidic junction further having an outlet in fluid communication with said first and second inlets such that any of the transport liquid and the calibration liquid can exit for introduction into said OPI, a first pump operably coupled to said first reservoir for causing a flow of the calibration liquid from said first reservoir into said first inlet, a second pump operably coupled to said seconsecond reservoir into said second inlet, and a controller operably coupled to said first pump for controlling said first pump; [the controller operably coupled to said second pump for controlling said second pump] (Emphases added by Examiner).
In other words, Covey discloses a system having one pump, one inlet, and one reservoir and merely lacks a second inlet, second reservoir, and second pump, each of which are required to function identically to the elements disclosed by Covey.
Furthermore, Covey discloses in [0057] the use of an internal standard being introduced into the transport fluid for use in calibration.
Accordingly, because Covey discloses the claimed invention except for an additional reservoir, inlet, and pump, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Covey to include a fluidic junction having a first inlet in fluid communication with a first reservoir containing a calibration liquid and a second inlet in fluid communication with a second reservoir containing a transport liquid, said fluidic junction further having an outlet in fluid communication with said first and second inlets such that any of the transport liquid and the calibration liquid can exit for introduction into said OPI, a first pump operably coupled to said first reservoir for causing a flow of the calibration liquid from said first reservoir into said first inlet, a second pump operably coupled to said seconsecond reservoir into said second inlet, and a controller operably coupled to said first pump for controlling said first pump; [the controller operably coupled to said second pump for controlling said second pump] (Emphases added by Examiner), since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Doing so would allow one to introduce the disclosed internal standards of Covey in a controllable fashion in the same manner in which the transport liquid is introduced, which would allow one to achieve better measurement accuracy.
Regarding claim 2, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the calibration system of Claim 1.
Covey further teaches [further comprising a second pump operably coupled to said second reservoir for causing flow of the transport liquid from said second reservoir into said second inlet of the fluidic junction], and wherein said controller is operably coupled to said second pump for adjusting a pumping speed thereof, thereby adjusting a flowrate of said transport liquid ([0131]; [0134]).
Regarding claim 3, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the calibration system of Claim 2.
Covey further teaches wherein said controller is configured to adjust a speed of said second pump so as to reduce the flowrate of the transport liquid during at least a portion of a temporal period during which the second pump is in an activated state ([0131]; [0134]; Examiner notes that the controller and pump of Covey is capable of such functionality, and that the claim only requires that the controller be ‘configured to’, which is interpreted as requiring only the capability to perform the function).
Regarding claim 4, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the calibration system of Claim 2.
Covey further teaches wherein said controller is configured to adjust the speed of the second pump so as to reduce the flowrate of the transport liquid prior to, or substantially concurrently with, or after activating said first pump for causing flow of the calibration liquid ([0131]; [0134]; Examiner notes that the controller and pump of Covey is capable of such functionality, and that the claim only requires that the controller be ‘configured to’, which is interpreted as requiring only the capability to perform the function).
Regarding claim 5, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the calibration system of Claim 1.
Covey further teaches wherein said controller is configured to reduce the flowrate of the transport liquid so as to inhibit overflow of a mixture of the transport liquid and the calibration liquid at a liquid/air interface of said OPI ([0131]; [0134]; Examiner notes that the controller and pump of Covey is capable of such functionality, and that the claim only requires that the controller be ‘configured to’, which is interpreted as requiring only the capability to perform the function; The only required functionality to achieve such an outcome is to control the flowrate, which is disclosed by Covey).
Regarding claim 8, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the calibration system of Claim 1.
Covey further teaches wherein said controller is configured to adjust the flowrate of said transport liquid so as to maintain a liquid/air interface of the OPI at a substantially uniform fluidic state ([0131]; [0134]; Examiner notes that the controller and pump of Covey is capable of such functionality, and that the claim only requires that the controller be ‘configured to’, which is interpreted as requiring only the capability to perform the function; The only required functionality to achieve such an outcome is to control the flowrate, which is disclosed by Covey).
Regarding claim 9, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the calibration system of Claim 8.
Covey further teaches wherein said controller is configured to adjust [both] the flowrate of the transport liquid [and a flowrate of the calibration liquid,] so as to maintain a flowrate of liquid into the OPI at a substantially constant level ([0131]; [0134]; Examiner notes that the controller and pump of Covey is capable of such functionality, and that the claim only requires that the controller be ‘configured to’, which is interpreted as requiring only the capability to perform the function; The only required functionality to achieve such an outcome is to control the flowrate, which is disclosed by Covey).
Regarding claim 12, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey teaches a [fluid handling system], comprising:
an open port interface (OPI) for receiving a sample (See Fig. 2, OPI disposed above acoustic droplet dispensing; Abstract; [0008]; [0056]; [0131]),
a (See Fig. 2, leftmost elements of figure, having a reservoir; [0130]-[0135]),
a fluidic junction having a [transport] liquid (See Fig. 2, leftmost elements of figure, having a reservoir connected to a junction via an inlet into the junction; See annotated Fig. below, where left circle is inlet, center circle is junction; [0130]-[0135]), said fluidic junction further having an [outlet] in fluid communication with said (See Fig. 2, outlet from fluidic junction in fluid communication with the OPI; See annotated Fig. below, where right circle is outlet; [0130]-[0135]),
[a
a controller
[the controller operably coupled to said .
PNG
media_image2.png
450
350
media_image2.png
Greyscale
Covey does not explicitly teach a first reservoir for storing a calibration liquid, a second reservoir for storing a transport liquid, a fluidic junction having a first inlet configured for fluid coupling with said first reservoir for receiving the [calibration] liquid and a second inlet configured for fluid coupling with said second reservoir for receiving said [transport] liquid, said fluidic junction further having an [outlet] in fluid communication with said first and second inletany of said transport liquid, said calibration liquid and a mixture thereof into said OPI, a first pump operably coupled to said first reservoir for causing a flow of the calibration liquid into said fluidic junction, [a second pump operably coupled to said second reservoir for causing a flow of the transport liquid into said fluidic junction], a controller operably coupled to said first pump for controlling operation thereof, [the controller operably coupled to said second pump for controlling operation thereof] (Emphases added by Examiner).
In other words, Covey discloses a system having one pump, one inlet, and one reservoir and merely lacks a second inlet, second reservoir, and second pump, each of which are required to function identically to the elements disclosed by Covey.
Furthermore, Covey discloses in [0057] the use of an internal standard being introduced into the transport fluid for use in calibration.
Accordingly, because Covey discloses the claimed invention except for an additional reservoir, inlet, and pump, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Covey to include a first reservoir for storing a calibration liquid, a second reservoir for storing a transport liquid, a fluidic junction having a first inlet configured for fluid coupling with said first reservoir for receiving the [calibration] liquid and a second inlet configured for fluid coupling with said second reservoir for receiving said [transport] liquid, said fluidic junction further having an [outlet] in fluid communication with said first and second inletany of said transport liquid, said calibration liquid and a mixture thereof into said OPI, a first pump operably coupled to said first reservoir for causing a flow of the calibration liquid into said fluidic junction, [a second pump operably coupled to said second reservoir for causing a flow of the transport liquid into said fluidic junction], a controller operably coupled to said first pump for controlling operation thereof, [the controller operably coupled to said second pump for controlling operation thereof] (Emphases added by Examiner), since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Doing so would allow one to introduce the disclosed internal standards of Covey in a controllable fashion in the same manner in which the transport liquid is introduced, which would allow one to achieve better measurement accuracy.
Regarding claim 13, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the [fluid handling system] of Claim 12.
Covey further teaches wherein said controller is configured for activating said first pump to cause a flow of the calibration liquid into said fluidic junction for calibrating [a] mass spectrometer [coupled to the fluid handling system] ([0131]; [0134]; Examiner notes that the controller and pump of Covey is capable of such functionality, and that the claim only requires that the controller be ‘configured to’, which is interpreted as requiring only the capability to perform the function; Examiner notes that ‘for calibrating a mass spectrometer coupled to the fluid handling system’ is interpreted as non-limiting intended use).
Regarding claim 15, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the [fluid handling system] of Claim [12].
Covey further teaches wherein said controller is configured to at least one of: (1) adjust a speed of said second pump so as to reduce the flowrate of the transport liquid into said fluidic junction during at least a portion of a temporal period during which said first pump is in an activated state; (2) to reduce the speed of said second pump prior to activating said first pump for reducing the flowrate of said transport liquid into said OPI so as to inhibit an overflow of a mixture of the transport liquid and the calibration liquid at a liquid/air interface of said OPI; and (3) to reduce the speed of said second pump substantially concurrently with activating said first pump ([0131]; [0134]; Examiner notes that the controller and pump of Covey is capable of such functionality, and that the claim only requires that the controller be ‘configured to’, which is interpreted as requiring only the capability to perform the function; The only required functionality to achieve such an outcome is to control the flowrate via the pump speed, which is disclosed by Covey).
Regarding claim 16, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the [fluid handling system] of Claim 12.
Covey further teaches wherein said OPI comprises an outer conduit and an inner conduit, wherein said outer conduit is configured to receive the transport liquid from the fluidic junction and to deliver said transport liquid to an inlet of the inner conduit in a sampling space at a liquid/air interface of said OPI (See Fig. 2, showing flow of transport liquid via arrows from the outlet of the fluidic junction, and showing the sample processing region, i.e., sampling space at liquid/air interface, and in particular see the annotated Fig. below, where the outer ovals indicate the outer conduit, and the inner oval indicates the inner conduit; [0130]-[0135]).
PNG
media_image3.png
437
344
media_image3.png
Greyscale
Regarding claim 17, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the [fluid handling system] of Claim 12.
Covey further teaches further comprising a sample reservoir for containing a sample (See Fig. 2, acoustic droplet dispensing from sample reservoir; [0130]-[0131]).
Regarding claim 18, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the [fluid handling system] of Claim 17.
Covey further teaches further comprising an acoustic transducer operably coupled to said sample reservoir for causing ejection of portions of said sample into said sampling space of the OPI such that said ejected portions of the sample are introduced into said inlet of the inner conduit and are entrained within a flow of said transport liquid to be transported to an outlet of said inner conduit of the OPI (See Fig. 2, acoustic droplet dispensing from sample reservoir into flow of transfer liquid indicated by arrows and dashed lines; [0130]-[0131]).
Regarding claim 19, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the [fluid handling system] of Claim 18.
Covey further teaches further comprising an ion source positioned downstream of said outlet of the inner conduit for receiving at least a portion of the sample exiting through the outlet of said inner conduit (See Fig. 2, righthand side of Fig. showing ionizer downstream of inner conduit; ([0130]-[0132]) and ionizing at least a portion of the received sample to generate a plurality of ions and further comprising one or more mass analyzers for receiving at least a portion of said plurality of ions and generating a mass spectrum thereof (Examiner notes these limitations are interpreted as not required, as they pertain to limitations of a system for use with the fluid handling system and not to the fluid handling system itself; However, Examiner notes for completeness that these limitations are disclosed in [0130]-[0135]), and wherein optionally said ion source comprise an ESI source and wherein optionally said one or more mass analyzers comprise any of a time-of-flight (TOF) mass analyzer, a quadrupole mass analyzer and a combination thereof (Examiner notes these limitations are interpreted as not required, first, because they are indicated as ‘optional’, and because they pertain to limitations of a system for use with the fluid handling system and not to the fluid handling system itself; However, Examiner notes for completeness that these limitations are disclosed in Fig. 2; [0104]; [0117]-[0121]; [0130]-[0135]).
Regarding claim 20, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey teaches a method of [introducing fluids into] a mass spectrometer having an OPI for receiving a sample (Abstract; [0001]; [0008]; [0026]), comprising:
introducing a transport liquid into a fluidic junction via a first inlet thereof such that said transport liquid flows from said first inlet to an outlet of said fluidic junction that is in communication with said OPI for introduction of said transport liquid into the OPI (See Fig. 2, wherein the fluidic junction and first inlet are those indicated in the annotated Fig. discussed in regards to claim 1, and wherein the outlet of the fluidic junction that is in communication with the OPI is that indicated in the annotated Fig. discussed in regards to claim 12; [0130]-[0135]), and
introducing a calibration solution ([0057]).
Covey does not explicitly teach introducing a calibration solution into said fluidic junction via a second inlet thereof to be mixed with said transport liquid for introduction into said OPI via said outlet of the fluidic junction (Emphases added by Examiner).
In other words, Covey discloses a system having one pump for introducing a transport liquid via one inlet into a fluidic junction and mixing a calibration fluid with the transfer liquid, and merely lacks a second inlet, second reservoir, and second pump for introducing the calibration solution specifically into the fluidic junction, wherein the second inlet is required to function identically to the elements disclosed by Covey.
Accordingly, because Covey discloses the claimed invention except for an additional inlet to introduce the calibration liquid into the fluidic junction, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Covey to include introducing a calibration solution into said fluidic junction via a second inlet thereof to be mixed with said transport liquid for introduction into said OPI via said outlet of the fluidic junction (Emphases added by Examiner), since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Doing so would allow one to introduce the disclosed internal standards of Covey in a controllable fashion in the same manner in which the transport liquid is introduced, which would allow one to achieve better measurement accuracy.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Covey (U.S. PGPub. No. US 20210121905 A1) in view of Liu (U.S. PGPub. No. US 20230207298 A1) and Datwani (U.S. PGPub. No. US 20190157061 A1) and/or Van Berkel (DOI: 10.1002/rcm.7274).
Examiner notes that Datwani and Van Berkel are Applicant provided prior art via the IDS dated 12/08/2023.
Regarding claim 6, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the calibration system of Claim 1.
Covey does not teach further comprising a flow monitor coupled to said fluidic junction for monitoring a flowrate of liquid introduced into said OPI.
The prior art Datwani (U.S. PGPub. No. US 20190157061 A1) and Van Berkel (DOI: 10.1002/rcm.7274) disclose monitoring the flowrate of liquid introduced into an OPI, including disclosure of why and under what circumstances, however, each lacks an explicit recitation of a flow monitoring structure. However, a generic flow monitor is well represented in the prior art, and accordingly, it is Examiner’s opinion that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Covey to include a flow monitor to achieve the flow monitoring disclosed by Datwani and/or Van Berkel using conventional flow monitoring technology.
Nevertheless, Liu teaches further comprising a flow monitor coupled to said fluidic junction for monitoring a flowrate of liquid introduced into said OPI (See Fig. 19, item 1940; [0204]-[0211]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Covey to include further comprising a flow monitor coupled to said fluidic junction for monitoring a flowrate of liquid introduced into said OPI, as taught by Liu.
Doing so represents combining known prior art elements according to known methods in order to achieve predictable results, and would allow one to monitor the flow rate of liquid entering the OPI to achieve the desired flow characteristics as disclosed by Datwani and/or Van Berkel.
Regarding claim 7, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, in view of Liu and Datwani and/or Van Berkel teaches the calibration system of Claim 6.
Liu further teaches wherein said controller is operably coupled to said flow monitor to receive one or more signals from said flow monitor indicative of the flowrate of the liquid flowing into said OPI via the outlet of said fluidic junction and wherein said controller is configured to adjust the flowrate of said transport liquid in response to said one or more signals received from the flow monitor (See Fig. 19, item 1940; [0204]-[0211]; See also Covey [0131] and [0134]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J GASSEN whose telephone number is (571)272-4363. The examiner can normally be reached M-F 9-5.
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 H 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.
/CHRISTOPHER J GASSEN/ Examiner, Art Unit 2881
/ROBERT H KIM/ Supervisory Patent Examiner, Art Unit 2881