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 amendments filed 05/04/2026 have been entered. Claims 14 and 17 have been canceled. Claims 1-9, 12-13, 15-16, and 18-20 are now pending in the application.
Response to Arguments
Applicant’s amendments to the drawings and specification have overcome each and every objection previously set forth in the Non-Final Office Action dated 02/04/2026, hereinafter NFOA0204.
Applicant’s amendments to the claims have overcome each and every objection previously set forth in NFOA0204. However, Applicant’s amendments have resulted in additional objection issues. See below for a detailed discussion.
Applicant’s amendments to the claims have overcome some, but not all of the 35 U.S.C. 112(b) rejections previously set forth in NFOA0204. Applicant’s amendments have resulted in additional indefiniteness issues. See below for a detailed discussion.
Applicant's arguments filed 05/04/2026 have been fully considered but they are not persuasive.
First, Applicant argues (See Remarks dated 05/04/2026, p. 13) that ‘the proposed modification of Covey is not obvious because the claimed invention and Covey are directed to different problems’. Applicant argues that the claimed invention is directed to a system for calibrating a mass spectrometer, and argues that Covey is directed to a method of calibrating a droplet dispenser to ensure the dispenser dispenses a precise and accurate volume of liquid. Applicant argues “An invention for calibrating a mass spectrometer is not an obvious variant of a system for calibrating a droplet dispenser’s volume. A person of ordinary skill in the art seeking to solve the problem addressed by Covey (i.e., improving droplet volume consistency) would not be motivated to develop a system for an entirely different purpose (i.e., calibrating the mass spectrometer’s mass accuracy). Thus, it is apparent that the Office Action’s reasoning applies impermissible hindsight by using Applicant’s own disclosure of a system for mass spectrometer calibration as a roadmap to modify the teachings of Covey.
Examiner respectfully disagrees with Applicant’s assessment.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, the prior art structure teaches all of the necessary structure except for a functional duplicate of a structure disclosed by the prior art. No hindsight reasoning was used to include such a structure, as duplicating a prior art disclosed structure in a system is within the abilities of an ordinarily skilled artisan, and furthermore, Covey discloses the use of internal standards ([0057]) and further discloses in [0150]: “The reference compound may be added to the transport fluid in the reservoir that supplies the capture probe, or may be injected as a supplement to the supply of transport fluid supplied to the sample processing region.”, which in the embodiment applied, would be limited to being located between the inlet of the transport fluid from its reservoir and the outlet of the fluidic junction.
In response to applicant's argument that Covey and the instant application are directed toward different intended uses, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Whether the disclosure of the instant Application is directed toward calibration of a mass spectrometer does not have any bearing on the claims. Claim 1 does not require any specific ‘calibration structure’, in that, the first reservoir, first pump, and first inlet are not structurally modified by being intended for ‘calibration liquid’. In this case, the structure of Covey, even absent modification, is capable of delivering a calibration liquid in a transport liquid to an OPI to entrain a sample for downstream ionization and analysis in a mass spectrometer. The only difference in the required structure is the delivering means for the calibration liquid.
Accordingly, Applicant’s arguments are not convincing.
Second, Applicant argues (See Remarks dated 05/04/2026, p. 14) that ‘Covey does not teach or suggest the claimed structure for the claimed purpose’. Applicant argues that the internal standard of Covey is intended to be used for droplet volume measurement, and not for calibrating the mass spectrometer itself. However, this is not convincing, as the type of calibration liquid is not particularly limited in the claims, and the claims do not require any limitations of the calibration liquid itself. Additionally, claim 1 only requires ‘a calibration system for use in a mass spectrometer’, which does not require that the calibration be used on the mass spectrometer itself. Furthermore, the calibration system claimed is directed entirely to flow control of liquids, using structures which are not modified by the particular type(s) of fluids being handled (i.e., the transport and calibration liquids are not limited by the claims, nor are the pumps/reservoirs/inlets required to have any different structural features/capabilities). Accordingly, this argument is not convincing for these reasons, and those discussed above in regards to Applicant’s first argument.
Applicant further argues that Covey suggests two ways to introduce the internal standard, namely, [0150]: “The reference compound may be added to the transport fluid in the reservoir that supplies the capture probe, or may be injected as a supplement to the supply of transport fluid supplied to the sample processing region.”. Applicant argues that “There is no teaching or suggestion in Covey’s disclosure to build a separately-pumped and independently-controlled additional fluidic sub-system, as claimed.”, and further argues the ‘purpose’ of the devices of Covey compared to the instant application, limitations not present in the claims (i.e., on-demand mass spec. calibration), and improper hindsight reconstruction.
Examiner respectfully disagrees.
This portion of Covey clearly at least teaches some means for ‘injecting as a supplement to the supply of transport fluid’, if not particularly limited. As can be seen in the applied embodiment, in order to inject such an internal standard ‘to the supply of transport fluid supplied to the sample processing region’, it must be injected downstream of the pump and inlet and prior to the sample processing region, which an ordinarily skilled artisan would understand as disclosing at least an additional inlet to the equivalent of the fluidic junction. Additionally, an ordinarily skilled artisan would readily understand that the internal standard/calibration compound would need to be held in some sort of container prior to injection, and thus, would naturally be held in some form of reservoir, which at least upon injection, is connected to the inlet. The word ‘injecting’ means ‘to introduce forcefully’ or ‘to force a fluid into’, and accordingly some mechanism for such forcing must be coupled to the reservoir. Covey does not explicitly disclose any such means.
However, were an ordinarily skilled artisan looking to reduce the device of Covey to practice, they would naturally look to the remaining disclosure of Covey for instruction of a fluid injecting means or use ordinary skill/knowledge (a fluid pump controlled by a controller to inject into a region would be known to an ordinarily skilled artisan). Covey discloses a fluid pump for controllably forcing a liquid into an inlet connected to a fluid junction (i.e., for the transport liquid), and an ordinarily skilled artisan would readily recognize that such a structure could function in a similar manner in the necessary disposal of such an ‘injection configuration’ of the internal standard/calibration compound. Accordingly, because duplicating prior art elements to achieve equivalent functionality has been held to be within the abilities of an ordinarily skilled artisan, it would be obvious to use a similar pumping arrangement to the transport stream for the disclosed inline injection of calibration liquid. Additionally, Covey discloses the requirement for the amount of calibration liquid and the relative proportions thereof compared to other elements of the fluid to be very precise ([0150]-[0151]), and accordingly, some form of precise control over the dispensing of the calibration liquid would be required. Accordingly, an ordinarily skilled artisan would understand such a disclosure to require precise control of the volume dispensed, and would look to Covey or ordinary skill/knowledge for instruction on means to perform such precise volume control. Again, Covey discloses the system having a computing element to control a fluid delivery pump ([0134]), among several other elements (i.e., the controller can control several elements simultaneously and independently). Accordingly, one of ordinary skill in the art could readily apply this means of control in the same manner to an additional pump/reservoir, using only the instruction found in Covey and ordinary knowledge/abilities.
Accordingly, Applicant’s arguments are not convincing.
Third, Applicant argues (See Remarks dated 05/04/2026, p. 15) that ‘Examiner’s “mere duplication” rationale is improper’. Applicant argues that the case law applied is not applicable, because “the system of Claim 1 does not simply duplicate parts from prior art as suggested by the Office Action. If the elements of Covey were merely duplicated, such duplication would only result in the addition of another inlet reservoir, pump, and control connection for transport fluid. By using two independently controlled pumps for two different liquids (transport and calibration liquids), the present invention enables on-demand calibration of the mass spectrometer without interrupting the sample analysis workflow.” Applicant additionally recites unclaimed functionality, claiming this arrangement “provides a new capability that is a significant technical improvement”, and that the system of claim 1 “creates a new functional relationship between multiple pumps, reservoirs, and fluids that results in a technical improvement”.
Examiner respectfully disagrees with Applicant’s assessment.
Applicant’s argument that “the system of Claim 1 does not simply duplicate parts from prior art as suggested by the Office Action. If the elements of Covey were merely duplicated, such duplication would only result in the addition of another inlet reservoir, pump, and control connection for transport fluid.” is not convincing. First, each of the parts present in claim 1 exist in Covey, and there are no ‘new’ elements over the prior art. Covey discloses a fluid input, coupled to a reservoir, coupled to a pump, coupled to a controller. Covey teaches a transport fluid and a calibration fluid. Covey explicitly teaches the reservoir holding the transport fluid to be introduced through the corresponding inlet via the controller and would be understood by an ordinarily skilled artisan to disclose some form of calibration fluid reservoir and inlet, at least implicitly. A second pump pushing a second fluid from a second reservoir does not change the structure of the constituent elements. There is nothing in particular about these elements in Covey that limit them to only be capable of handling transport fluid. An ordinarily skilled artisan would readily recognize the reservoir, the pump, and the control connection of Covey as being applicable to alternative liquids, as they would function identically for such a different fluid (such as the disclosed internal standard of Covey) in this context. Additionally, ‘transport liquid’ and ‘calibration liquid’ are not particularly limit by the claim (e.g., there is no limitation requiring them to be different substances), so the assertion that a pump disclosed in the prior art to be configured to be controlled by a controller to inject fluid from a reservoir, through an inlet, into a fluid junction, can only function with an arbitrary, non-limited transport liquid is not convincing, and is at odds with what would be understood by an ordinarily skilled artisan, who in the field of ESI/MS applications would likely hold an advanced degree in the chemical/physical/engineering fields, and thus would have a reasonably high level of ordinary skill.
Applicant’s argument that this arrangement “provides a new capability that is a significant technical improvement” and that the system of claim 1 “creates a new functional relationship between multiple pumps, reservoirs, and fluids” are not convincing, as they do not point to any particular claim limitations to distinguish over the teachings of Covey, and are directed toward general capabilities discussed in the disclosure.
As such, Applicant’s arguments are not convincing.
Claim Objections
Claims 9 and 15 are objected to because of the following informalities:
Claim 9 recites “the both the”, which appears to be a typographical clerical error, which should read ‘both the’;
Claim 15 recites “said controller is configured to…prior to activating said first pump, to reduce…”, which has a superfluous ‘to’ and should read ‘said controller is configured to…prior to activating said first pump, reduce…’.
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 12-13, 15-16, and 18-19 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.
Regarding claim 12, the claim has been amended to recite “an ion source configured to receive at least a portion of the sample exiting the OPI…”, however, the claim does not previously require the sample to exit the OPI or the OPI being configured to transmit the sample therefrom, as the claim only previously requires (1) the OPI being capable of receiving the sample from the sample reservoir, (2) structure for providing the fluids to the OPI, and (3) control of this providing. However, the claim lacks any recited structure or functionality causing the sample to exit the OPI, amounting to a gap in the requirements of the claim. 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 though the claim recites ‘wherein the OPI is configured to allow the sample received from the sample reservoir to exit the OPI;’ prior to this limitation, so as to bridge the gap between the received sample and the sample exiting the OPI.
Examiner notes for completeness that claim 19 does not have the same issue despite reciting similar language, because claim 19 depends on claims 18 and 16, which require specific structures of the OPI, including structure/functionality for transporting portions of the sample to an outlet of the OPI, and thus ‘sample exiting’ would be understood by an ordinarily skilled artisan in this context to refer to the sample that is transported to an outlet of the OPI.
Claim 15 has not been amended to change its dependence. As discussed in NFOA0204, because the elements of previous claim 14 were required by claim 12 as interpreted, claim 15 was accordingly interpreted as depending on claim 12. While Applicant has properly amended claim 12 to include the elements of 14, claim 15 now depends on a canceled claim, and as such, it is not possible to adequately determine the metes and bounds of the claim, rendering it indefinite. For purposes of examination, claim 15 is interpreted as depending on claim 12.
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, 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 operably coupled to said ([0134]).
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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 second reservoir for causing a flow of the transport liquid from said second reservoir into said second inlet, and a controller operably coupled to said first pump for controlling said first pump, and 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. Examiner additionally notes the above discussion regarding [0150], wherein the disclosure includes “The reference compound…may be injected as a supplement to the supply of transport fluid supplied to the sample processing region.”, which an ordinarily skilled artisan would understand as inherently requiring some form of reservoir and inlet at least at the time of injection. Furthermore, the same section discusses the need for precise control of such volumes.
Accordingly, because Covey discloses the claimed invention except for explicit disclosure of an additional reservoir and inlet, and disclosure of an additional 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, and 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 disclosed manner (i.e., in-line with the transport fluid), in a controllable fashion (i.e., via the disclosed control of the disclosed pump) in the same manner in which the transport liquid is introduced (i.e., the pumping mechanism would operate the same on the internal standard), which would allow one to achieve better measurement accuracy (i.e., by better controlling the volumes, and thus allowing better control of the calibration master curves).
Regarding claim 2, Covey, as modified, teaches the calibration system of Claim 1.
Covey further teaches wherein said controller is operably coupled to said second pump for adjusting a pumping speed of the second pump, thereby adjusting a flowrate of said transport liquid ([0131]; [0134]).
Regarding claim 3, Covey, as modified, teaches the calibration system of Claim 2.
Covey further teaches wherein said controller is configured to adjust the pumping 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, Covey, as modified, teaches the calibration system of Claim 2.
Covey further teaches wherein said controller is configured to adjust the pumping 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; The disclosed controller is capable of independent control of multiple elements).
Regarding claim 5, Covey, as modified, teaches the calibration system of Claim 1.
Covey further teaches wherein said controller is configured to reduce a 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, Covey, as modified, teaches the calibration system of Claim 1.
Covey further teaches wherein said controller is configured to adjust a 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, Covey, as modified, teaches the calibration system of Claim 8.
Covey further teaches wherein said controller is configured to adjust [[the]] 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 system for processing a sample (See Fig. 2, showing sample processing region; Abstract), comprising:
a sample reservoir for containing the sample (See Fig. 2, acoustic droplet dispensing having a reservoir holding the sample; [0130]-[0131]),
an open port interface (OPI) for receiving the sample from the sample reservoir (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 (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 (See Fig. 2, pump shown on leftmost portion of figure; [0130]-[0135]),
a controller of said second pump ([0134]), and
[wherein the OPI is configured to allow the sample received from the sample reservoir to exit the OPI,]
a mass spectrometer (See Fig. 2, bottom right, showing aperture, mass filter, and ion detector; [0133]) comprising:
an ion source configured to receive at least a portion of the sample exiting the OPI and to ionize at least a portion of the received portion of the sample to generate a plurality of ions (See Fig. 2, left of mass spectrometer aperture, showing ionization source producing a plurality of ions from the received portion of the sample from the upstream OPI on the bottom left of the figure; [0132]), and
one or more mass analyzers configured to receive at least a portion of said plurality of ions and to generate a mass spectrum of the portion of said plurality of ions (See Fig. 2, bottom right, showing mass filter and ion detector; [0133]).
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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 and configured to cause a flow of the calibration liquid into said fluidic junction, a second pump operably coupled to said second reservoir and configured to cause a flow of the transport liquid into said fluidic junction, a controller operably coupled to said first pump for controlling operation of said first pump, and operably coupled to said second pump for controlling operation of 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. Examiner additionally notes the above discussion regarding [0150], wherein the disclosure includes “The reference compound…may be injected as a supplement to the supply of transport fluid supplied to the sample processing region.”, which an ordinarily skilled artisan would understand as inherently requiring some form of reservoir and inlet at least at the time of injection. Furthermore, the same section discusses the need for precise control of such volumes.
Accordingly, because Covey discloses the claimed invention except for explicit disclosure of an additional reservoir and inlet, and disclosure of an additional 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 and configured to cause a flow of the calibration liquid into said fluidic junction, a second pump operably coupled to said second reservoir and configured to cause a flow of the transport liquid into said fluidic junction, a controller operably coupled to said first pump for controlling operation of said first pump, and operably coupled to said second pump for controlling operation of 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 disclosed manner (i.e., in-line with the transport fluid), in a controllable fashion (i.e., via the disclosed control of the disclosed pump) in the same manner in which the transport liquid is introduced (i.e., the pumping mechanism would operate the same on the internal standard), which would allow one to achieve better measurement accuracy (i.e., by better controlling the volumes, and thus allowing better control of the calibration master curves).
Regarding claim 13, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the 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 said mass spectrometer ([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, as the functionality required is activating a pump to cause flow of a liquid).
Regarding claim 15, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the 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 a 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) 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; 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 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]).
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Regarding claim 18, as best understood in view of the 35 U.S.C. 112(b) issues identified above, Covey, as modified, teaches the system of Claim 16.
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 system of Claim 18.
Covey further teaches wherein the ion source is configured to receive the portion of the sample exiting the OPI through the outlet of said inner conduit (See Fig. 2, righthand side of Fig. showing ionizer downstream of inner conduit, receiving sample exiting OPI; [0130]-[0132]), and wherein optionally said ion source comprises 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’; 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).
Examiner additionally notes the above discussion regarding [0150], wherein the disclosure includes “The reference compound…may be injected as a supplement to the supply of transport fluid supplied to the sample processing region.”, which an ordinarily skilled artisan would understand as inherently requiring some form of reservoir and inlet at least at the time of injection. Furthermore, the same section discusses the need for precise control of such volumes. One of ordinary skill in the art could thus reasonably interpret this as implicit disclosure of the above limitations.
Nevertheless, 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 explicit disclosure of a second inlet and second reservoir, and disclosure of a 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 disclosed manner (i.e., in-line with the transport fluid), in a controllable fashion (i.e., via the disclosed control of the disclosed pump) in the same manner in which the transport liquid is introduced (i.e., the pumping mechanism would operate the same on the internal standard), which would allow one to achieve better measurement accuracy (i.e., by better controlling the volumes, and thus allowing better control of the calibration master curves).
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, 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, 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 a 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wyrick (US 20090145576 A1);
Smith (US 20090145485 A1);
Liu (DOI: 10.1021/acs.analchem.0c02999);
Burguera (DOI: 10.1039/a607974a);
Rampler (DOI: 10.1021/acs.analchem.0c04698).
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 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.
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/CHRISTOPHER J GASSEN/ Examiner, Art Unit 2881
/MICHAEL J LOGIE/ Primary Examiner, Art Unit 2881
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