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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, and 8-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crane et al. (US 20120240656 A1)[hereinafter “Crane”].
Regarding Claim 1, Crane discloses a point-of-use calibration system for an ion detection system [Abstract – “A sensor kit comprising a sensor for detecting an analyte, a sensor housing and a calibration chamber. The calibration chamber comprises a first compartment containing a first calibration solution and a second compartment containing a source of the analyte to be detected.”Paragraph [0044] – “The present invention is appropriate for use with any type of sensor which requires calibration, but is particularly useful for sensors which must be maintained in a sterile condition. This includes sensors for carrying out in vitro testing, whose accuracy may be affected by increased bacterial counts. For example, bacterial presence can influence the pH of a sensor and therefore affect accuracy. However, the present invention is particularly useful for invasive or implantable sensors (hereinafter invasive sensors) which must be maintained in a sterile condition during storage and calibration.”Paragraph [0045] – “Such invasive sensors include sensors for determining a variety of properties, typically properties of blood, although other tissues may also be subject to sensing Potassium, urea, creatinin and glucose sensors are examples of such invasive sensors. The present invention will be described further with reference to a particular type of invasive glucose sensor, but it should be understood that the invention is not limited to such sensors.” Potassium being ionic.] comprising:
at least a first chamber and a second chamber [Paragraph [0078] – “An alternative embodiment of the calibration chamber is depicted in FIG. 3c. In this embodiment, three compartments, 101, 102 and 103 are present.”],
wherein the first chamber includes a first ionic solution, and wherein the second chamber includes a second ionic solution [Paragraph [0078] – “Compartment 103 contains a second source of analyte, thus providing a third calibration solution having a higher concentration of analyte than the first or second calibration solutions.”Paragraph [0021] – “Once the sensing region is exposed to the contents of the first compartment, a reading of the analyte concentration of the solution in the first compartment (the first calibration solution) can be taken.”Paragraph [0022] – “The source of analyte within the second compartment, containing a known quantity of analyte, will thus be mixed with the water or aqueous solution of the first compartment, providing a second calibration solution having a known concentration of analyte.”Paragraph [0027] – “A further preferred embodiment involves a three point calibration. In this embodiment, the calibration chamber includes a second source of the analyte. On mixing of the second source of analyte into the solution, a third calibration solution is generated having a greater concentration of analyte than the first and second solutions. By taking a third reading of the sensor output for this third solution, a third calibration point can be generated.”].
Regarding Claim 2, Crane discloses the first chamber having an upper opening [See Fig. 3c and Paragraph [0054] – “To enable the sensor to be inserted, outer wall 13 of the first compartment is typically at least in part piercable. For example, the outer wall 13 may be a septum which can be pierced by a needle. The sensor can be inserted into the first compartment through or within the needle. Once the sensing region is in place within the first compartment, a first reading of the sensor output is taken.” Wall surrounding the side pointed to by the number 13.] and a lower opening [Paragraph [0078] – “A dividing material 11, 11a separates each compartment. This embodiment provides a three point calibration by a different means. Following taking of the first reading, the first dividing material 11 is ruptured/broken/removed as discussed in other embodiments, the contents of first and second compartments are mixed and a second calibration solution is obtained.” Wall surrounding 11 on the 101 chamber side.];
the second chamber having an opening [Wall surrounding 11 on the 102 chamber side.];
a seal disposed between the lower opening of the first chamber and the opening of the second chamber [dividing material 11]; and
a cap disposed on the upper opening of the first chamber [Paragraph [0054] – “To enable the sensor to be inserted, outer wall 13 of the first compartment is typically at least in part piercable. For example, the outer wall 13 may be a septum which can be pierced by a needle.”],
wherein the first chamber, the second chamber, the seal, and the cap are aligned on a common axis [Fig. 3c, horizontal axis].
Regarding Claim 8, Crane discloses a multi-chambered vial comprising: at least two chambers [Paragraph [0078] – “An alternative embodiment of the calibration chamber is depicted in FIG. 3c. In this embodiment, three compartments, 101, 102 and 103 are present.”] wherein the at least two chambers are aligned on a common vertical axis [Fig. 3c, horizontal axis];
a first chamber of the at least two chambers is a top chamber [Fig. 3c, compartment 101] and a second chamber of the at least two chambers is a bottom chamber [Fig. 3c, compartment 103], wherein the top chamber has an upper opening [See Fig. 3c and Paragraph [0054] – “To enable the sensor to be inserted, outer wall 13 of the first compartment is typically at least in part piercable. For example, the outer wall 13 may be a septum which can be pierced by a needle. The sensor can be inserted into the first compartment through or within the needle. Once the sensing region is in place within the first compartment, a first reading of the sensor output is taken.” Wall surrounding the side pointed to by the number 13.] and a lower opening [Paragraph [0078] – “A dividing material 11, 11a separates each compartment. This embodiment provides a three point calibration by a different means. Following taking of the first reading, the first dividing material 11 is ruptured/broken/removed as discussed in other embodiments, the contents of first and second compartments are mixed and a second calibration solution is obtained.” Wall surrounding 11 on the 101 chamber side.], and the lower chamber has an opening [Wall surrounding 11a on the 103 chamber side.];
a pierceable cap disposed on a top opening of the top chamber [Paragraph [0054] – “To enable the sensor to be inserted, outer wall 13 of the first compartment is typically at least in part piercable. For example, the outer wall 13 may be a septum which can be pierced by a needle.”];
a pierceable seal disposed between every chamber of the at least two chambers [Paragraph [0078] – “A dividing material 11, 11a separates each compartment. This embodiment provides a three point calibration by a different means. Following taking of the first reading, the first dividing material 11 is ruptured/broken/removed as discussed in other embodiments, the contents of first and second compartments are mixed and a second calibration solution is obtained.”]; and
at least two acquis solutions wherein the at least two acquis solutions consist of different ionic concentrations [Paragraph [0078] – “This embodiment provides a three point calibration by a different means. Following taking of the first reading, the first dividing material 11 is ruptured/broken/removed as discussed in other embodiments, the contents of first and second compartments are mixed and a second calibration solution is obtained. A second reading is then taken. Subsequently, the second dividing material 11a is ruptured/broken/removed allowing the contents of compartment 103 to mix with the second calibration solution. Compartment 103 contains a second source of analyte, thus providing a third calibration solution having a higher concentration of analyte than the first or second calibration solutions. A third reading can be taken and a calibration curve generated. This embodiment is appropriate for carrying out a three point calibration where the first and second sources of analyte are concentrated solutions of the analyte or the analyte in solid form.”].
Regarding Claim 9, Crane discloses that a retaining ring is disposed on the pierceable cap [Wall surrounding the side pointed to by the number 13.] and around each pierceable seal [Wall surrounding 11a on the 103 chamber side.].
Regarding Claim 10, Crane discloses that the at least two chambers include a third chamber [Fig. 3c, compartment 102] having an upper opening [Wall surrounding 11 on the 102 chamber side.] and a lower opening [Wall surrounding 11a on the 102 chamber side.], wherein the third chamber is disposed between the top chamber and the bottom chamber [Fig. 3c, compartment 102], and wherein the third chamber has a different ionic concentration than the first and second chambers [Paragraph [0078] – “This embodiment provides a three point calibration by a different means. Following taking of the first reading, the first dividing material 11 is ruptured/broken/removed as discussed in other embodiments, the contents of first and second compartments are mixed and a second calibration solution is obtained. A second reading is then taken. Subsequently, the second dividing material 11a is ruptured/broken/removed allowing the contents of compartment 103 to mix with the second calibration solution. Compartment 103 contains a second source of analyte, thus providing a third calibration solution having a higher concentration of analyte than the first or second calibration solutions. A third reading can be taken and a calibration curve generated. This embodiment is appropriate for carrying out a three point calibration where the first and second sources of analyte are concentrated solutions of the analyte or the analyte in solid form.”].
Regarding Claim 11, Crane discloses a method for using a point-of-use calibration system for an ion detection system [Abstract – “A sensor kit comprising a sensor for detecting an analyte, a sensor housing and a calibration chamber. The calibration chamber comprises a first compartment containing a first calibration solution and a second compartment containing a source of the analyte to be detected.”Paragraph [0044] – “The present invention is appropriate for use with any type of sensor which requires calibration, but is particularly useful for sensors which must be maintained in a sterile condition. This includes sensors for carrying out in vitro testing, whose accuracy may be affected by increased bacterial counts. For example, bacterial presence can influence the pH of a sensor and therefore affect accuracy. However, the present invention is particularly useful for invasive or implantable sensors (hereinafter invasive sensors) which must be maintained in a sterile condition during storage and calibration.”Paragraph [0045] – “Such invasive sensors include sensors for determining a variety of properties, typically properties of blood, although other tissues may also be subject to sensing Potassium, urea, creatinin and glucose sensors are examples of such invasive sensors. The present invention will be described further with reference to a particular type of invasive glucose sensor, but it should be understood that the invention is not limited to such sensors.” Potassium being ionic.] comprising the steps of:
providing a multi-chambered vial comprising: at least two chambers [Paragraph [0078] – “An alternative embodiment of the calibration chamber is depicted in FIG. 3c. In this embodiment, three compartments, 101, 102 and 103 are present.”] wherein the at least two chambers are aligned on a common vertical axis [Fig. 3c, horizontal axis];
a first chamber of the at least two chambers is a top chamber [Fig. 3c, compartment 101] and a second chamber of the at least two chambers is a bottom chamber [Fig. 3c, compartment 103], wherein the top chamber has an upper opening [See Fig. 3c and Paragraph [0054] – “To enable the sensor to be inserted, outer wall 13 of the first compartment is typically at least in part piercable. For example, the outer wall 13 may be a septum which can be pierced by a needle. The sensor can be inserted into the first compartment through or within the needle. Once the sensing region is in place within the first compartment, a first reading of the sensor output is taken.” Wall surrounding the side pointed to by the number 13.] and a lower opening [Paragraph [0078] – “A dividing material 11, 11a separates each compartment. This embodiment provides a three point calibration by a different means. Following taking of the first reading, the first dividing material 11 is ruptured/broken/removed as discussed in other embodiments, the contents of first and second compartments are mixed and a second calibration solution is obtained.” Wall surrounding 11 on the 101 chamber side.], and the lower chamber has an opening [Wall surrounding 11a on the 103 chamber side.];
a pierceable cap disposed on a top opening of the top chamber [Paragraph [0054] – “To enable the sensor to be inserted, outer wall 13 of the first compartment is typically at least in part piercable. For example, the outer wall 13 may be a septum which can be pierced by a needle.”];
a pierceable seal disposed between every chamber of the at least two chambers [Paragraph [0078] – “A dividing material 11, 11a separates each compartment. This embodiment provides a three point calibration by a different means. Following taking of the first reading, the first dividing material 11 is ruptured/broken/removed as discussed in other embodiments, the contents of first and second compartments are mixed and a second calibration solution is obtained.”]; and
at least two acquis solutions wherein a first acquis solution is contained within the top chamber, and a second acquis solution is contained within the bottom chamber [Paragraph [0078] – “This embodiment provides a three point calibration by a different means. Following taking of the first reading, the first dividing material 11 is ruptured/broken/removed as discussed in other embodiments, the contents of first and second compartments are mixed and a second calibration solution is obtained. A second reading is then taken. Subsequently, the second dividing material 11a is ruptured/broken/removed allowing the contents of compartment 103 to mix with the second calibration solution. Compartment 103 contains a second source of analyte, thus providing a third calibration solution having a higher concentration of analyte than the first or second calibration solutions. A third reading can be taken and a calibration curve generated. This embodiment is appropriate for carrying out a three point calibration where the first and second sources of analyte are concentrated solutions of the analyte or the analyte in solid form.”];
providing an ion-detection needle having a proximal end and a distal end, wherein an ion detector is disposed on the distal end [Paragraph [0047] – “One particular invasive glucose sensor is based on a fibre optic technique and is depicted in FIG. 1. The sensor 1 comprises an insertable tip 2 which is adapted for insertion into a patient, for example insertion into a blood vessel through a cannular. The insertable tip includes a sensing region 3 (depicted in more detail in FIG. 2) in which the glucose receptor 4, and typically also a temperature sensor 5, are positioned.”Paragraph [0056] – “In a typical embodiment, the sensor is inserted into the first compartment within a needle, and the needle, containing the sensor, can then be pushed forwards to rupture the dividing material.”];
providing a feedback system that is in communication with the ion detector [Paragraph [0061] – “Typically, the calibration is carried out by connecting connection 8 of the sensor to a monitor adapted for continuous measurement of the sensor output.”Paragraph [0078] – “a calibration curve generated”];
inserting the ion-detection needle through the pierceable cap and into the first acquis solution [Paragraph [0056] – “In a typical embodiment, the sensor is inserted into the first compartment within a needle, and the needle, containing the sensor, can then be pushed forwards to rupture the dividing material.”];
acquiring a first feedback signal from the feedback system [Paragraph [0078] – “taking of the first reading”];
inserting the ion-detection needle through the pierceable seal and into the second acquis solution [Paragraph [0056] – “In a typical embodiment, the sensor is inserted into the first compartment within a needle, and the needle, containing the sensor, can then be pushed forwards to rupture the dividing material.”];
acquiring a second feedback signal from the feedback system [Paragraph [0078] – “A second reading is then taken.”];
comparing the differences between the first feedback signal and the second feedback signal [Paragraph [0078] – “A third reading can be taken and a calibration curve generated. This embodiment is appropriate for carrying out a three point calibration where the first and second sources of analyte are concentrated solutions of the analyte or the analyte in solid form.”].
Claim Rejections - 35 USC § 103
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.
Claim(s) 3, 4, 5, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crane et al. (US 20120240656 A1)[hereinafter “Crane”] and Gohil et al. (US 20120058564 A1)[hereinafter “Gohil”].
Regarding Claim 3, Crane fails to disclose that the first ionic solution contains a first concentration of iron ions, and the second ionic solution contains a second concentration of iron ions.
However, Gohil discloses the use of a probe for detecting iron levels [Abstract – “The method comprises of employing a signal generating moiety capable of complexing with iron that is a peptide like molecule having an iron binding site and also an optical signal generating functional group. The molecule is of microbial origin. The measurement is based on the alteration of optical characteristics of the probe molecule upon attachment of iron to its binding site on the molecule. Hence it generates a signal proportionate to the amount of iron available for binding and provides a direct estimate of free or unbound iron in the sample. According to this instant invention a rapid estimation method of NTBI in body fluids can be undertaken in an inexpensive way without the need of specialized expertise.”Paragraph [0042] – “In the instant invention the biomedical method provided for the estimation of NTBI in circulating body fluids, comprising of a detection probe which has an iron binding moiety, and also a signal generating moiety. The intensity of generated signal is related to an amount of the iron bound to the detection probe.”]. It would have been obvious to have the solutions include iron ions so that a calibration curve for such a probe could be effectively generated.
Regarding Claim 4, Crane discloses that the seal [Paragraph [0056] – “In a typical embodiment, the sensor is inserted into the first compartment within a needle, and the needle, containing the sensor, can then be pushed forwards to rupture the dividing material.”] and the cap are constructed of a needle-pierceable material [See Fig. 3c and Paragraph [0054] – “To enable the sensor to be inserted, outer wall 13 of the first compartment is typically at least in part piercable. For example, the outer wall 13 may be a septum which can be pierced by a needle. The sensor can be inserted into the first compartment through or within the needle. Once the sensing region is in place within the first compartment, a first reading of the sensor output is taken.”].
Regarding Claim 5, Crane discloses an ion-detection needle having a proximal end and a distal end, wherein an ion detector is disposed on the distal end [Paragraph [0047] – “One particular invasive glucose sensor is based on a fibre optic technique and is depicted in FIG. 1. The sensor 1 comprises an insertable tip 2 which is adapted for insertion into a patient, for example insertion into a blood vessel through a cannular. The insertable tip includes a sensing region 3 (depicted in more detail in FIG. 2) in which the glucose receptor 4, and typically also a temperature sensor 5, are positioned.”Paragraph [0056] – “In a typical embodiment, the sensor is inserted into the first compartment within a needle, and the needle, containing the sensor, can then be pushed forwards to rupture the dividing material.”].
Regarding Claim 12, Crane fails to disclose that the first acquis solution has a first iron ion concentration, and the second acquis solution has a second iron ion concentration.
However, Gohil discloses the use of a probe for detecting iron levels [Abstract – “The method comprises of employing a signal generating moiety capable of complexing with iron that is a peptide like molecule having an iron binding site and also an optical signal generating functional group. The molecule is of microbial origin. The measurement is based on the alteration of optical characteristics of the probe molecule upon attachment of iron to its binding site on the molecule. Hence it generates a signal proportionate to the amount of iron available for binding and provides a direct estimate of free or unbound iron in the sample. According to this instant invention a rapid estimation method of NTBI in body fluids can be undertaken in an inexpensive way without the need of specialized expertise.”Paragraph [0042] – “In the instant invention the biomedical method provided for the estimation of NTBI in circulating body fluids, comprising of a detection probe which has an iron binding moiety, and also a signal generating moiety. The intensity of generated signal is related to an amount of the iron bound to the detection probe.”]. It would have been obvious to have the solutions include iron ions so that a calibration curve for such a probe could be effectively generated.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crane et al. (US 20120240656 A1)[hereinafter “Crane”], Gohil et al. (US 20120058564 A1)[hereinafter “Gohil”], and Sipple (US 20170172507 A1).
Regarding Claim 6, Crane discloses that the ion detector is in communication with a feedback system [Paragraph [0061] – “Typically, the calibration is carried out by connecting connection 8 of the sensor to a monitor adapted for continuous measurement of the sensor output.”Paragraph [0078] – “a calibration curve generated”], but fails to disclose that the proximal end of the ion-detection needle is disposed onto a syringe.
However, Sipple discloses the use of syringe that produces measurements [Paragraph [0029] – “FIGS. 7 and 8 illustrate typical needles used for injection into or near the spine that can be coated with the biomarker detector coating.”]. It would have been obvious to test a syringe with measurement capabilities in order to ensure that it can function properly.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crane et al. (US 20120240656 A1)[hereinafter “Crane”], Gohil et al. (US 20120058564 A1)[hereinafter “Gohil”], Sipple (US 20170172507 A1), and Kryzer (US 20140270288 A1).
Regarding Claim 7, Crane fails to disclose that the feedback system is selected from the group consisting of an indicator light, a numeric digital display, a variable tone generator, or a variable color display, and combinations thereof.
However, Kryzer discloses the use of such technology [See Paragraph [0026]]. It would have been obvious to use such technology in order to present the measuring/calibration data for a user to better understand [See Figs. 9A/9B of Crane].
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crane et al. (US 20120240656 A1)[hereinafter “Crane”] and Ikeda et al. (US 20140080167 A1)[hereinafter “Ikeda”].
Regarding Claim 13, Crane fails to disclose the step of discarding the ion-detection needle when the comparison of the first feedback signal and the second feedback signal provides no discernable difference.
However, Ikeda discloses comparing sensor measurement results in determining when a sensor needs to be replaced [See Abstract]. It would have been obvious to discard a sensor that does not produce differing sensing results when encountering different solutions because that would indicate that the sensor is not operating as intended.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20060034730 A1 – Methods For Assessing A Condition By Analyzing Blood In Cerebrospinal Fluid
US 20210148888 A1 – Accurate Sensing Of Physiological Substance In Blood
US 20120271248 A1 – MARKED PRECOATED MEDICAL DEVICE AND METHOD OF MANUFACTURING SAME
US 20190105123 A1 – Device And Methods Of Needle Calibration
US 5645824 A – Color Changing Reagent Composition For Coating On Needles Used In Medical Applications
US 5855896 A – Color Changing Composition And Method For Coating Said Composition On Acupuncture Needles, Hypodermic Syringes And Other Needles Used In Medical Applications
US 5992211 A – Calibrated Medical Sensing Catheter System
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/KYLE R QUIGLEY/Primary Examiner, Art Unit 2857