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 § 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-35 are rejected under 35 U.S.C. 103 as being unpatentable over Thompson et al. (U.S. Publication No. 2017/0252474 A1) in view of Bommarito et al. (U.S. Publication No. 2016/0178538 A1).
With respect to claim 1, Thompson et al. discloses a biological indicator system for determining the efficacy of a sterilization process (para 0081, lines 1-6), the biological indicator system (biological indicator 100 shows a sterilization cabinet with a biological indicator shown in Fig. 1) comprising:
Thompson et al. does not disclose a radiofrequency identification sensing board comprising a radiofrequency identification tag that includes a radiofrequency integrated circuit and an antenna, a microcontroller, a sensing pad, and a circuit coupled to the sensing pad and configured to measure an impedance level or resistance level of the sensing pad upon exposure to a volatile organic compound.
Bommarito et al. discloses a radiofrequency identification sensing board comprising a radiofrequency identification tag that includes a radiofrequency integrated circuit (while not explicitly called “RFID” the reference teaches wireless RF sensing using an antenna and resonant circuit, which is commonly considered RFID-type sensing in the art) and an antenna (see Fig. 1, elements 110, 112 and 120; para 0020-0035), a microcontroller (an analyzer 153 shown in Fig. 4, it’s a signal processing circuitry performing equivalent control and analysis function) a sensing pad (moisture absorbing layer/sensor structure 110 positioned to interact with sterilized articles. Changes electrical behavior when exposed to moisture; the moisture absorbing layer 130 shown in Fig. 4; para 0029, lines 1-7), and a circuit coupled to the sensing pad (see resonant circuit 111/112, resonant frequency shifts based on impedance change and moisture alters dielectric properties which directly impacts impedance change; para 0029-0031) and configured to measure an impedance level or resistance level of the sensing pad upon exposure to a volatile organic compound (exposure to moisture/water vapor, water vapor being a volatile compound; para 0025).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Thompson et al. to include a radiofrequency identification sensing board comprising a radiofrequency identification tag that includes a radiofrequency integrated circuit and an antenna, a microcontroller, a sensing pad, and a circuit coupled to the sensing pad and configured to measure an impedance level or resistance level of the sensing pad upon exposure to a volatile organic compound as taught by Bommarito et al. to allow for non-invasive, wireless detection of sterilization-related biological changes without opening the biological indicator container.
With respect to claim 2, the combination of Thompson et al. and Bommarito et al. discloses the biological indicator system of claim 1, further comprising a biological indicator (biological indicator 202 shown in Fig. 2, para 0082, lines 1-8) and a growth medium (see Thompson et al. showing a biological indicator assembly with a liquid growth medium fluid 732, Fig. 19; para 0129, lines 9-16), wherein the radiofrequency identification sensing board, the biological indicator (see Thompson et al. para 0129, lines 1-10), and the growth medium are sealed within a container by a cap (see Thompson et al. cap 720 shown in Fig. 19).
With respect to claim 3, Thompson et al. and Bommarito et al. discloses the biological indicator system of claim 2, regarding the headspace distance between the growth medium and the cap discloses a distance but does not disclose a particular value for this parameter. However, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide a wherein a headspace distance between the growth medium and the cap ranges from about 4 millimeters to about 16 millimeters, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the “optimum range” involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
With respect to claim 4, Thompson et al. and Bommarito et al. discloses the biological indicator system of claim 2, wherein a filter is disposed between the radiofrequency identification sensing board and the growth medium (see Thompson et al. protective and functional layers separating sensing electronics from biological materials, intermediate layer separating electronics, Thompson et al. para 0042-0048).
With respect to claim 5, Thompson et al. and Bommarito et al. discloses the biological indicator system of claim 4, regarding the thickness of the polymer coating of Thompson et al. and Bommarito et al. discloses a thickness but does not disclose a particular value for this parameter. However, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide a polymer coating having a thickness ranging from about 0.01 micrometers to about 5 micrometers, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the “optimum range” involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
With respect to claim 6, Thompson et al. and Bommarito et al. discloses the biological indicator system of claim 1, wherein the sensing pad is disposed on a lower surface of the radiofrequency identification sensing board (para 0094, lines 1-8).
With respect to claim 7, Thompson et al. and Bommarito et al. discloses the biological indicator system of claim 6, wherein the sensing pad is in contact with a gap electrode or an interdigitated electrode coated with a film (see sensor 840 which is considered the gap electrode Fig. 20).
With respect to claim 8, Thompson et al. and Bommarito et al. discloses the biological indicator system of claim 7, regarding the gap electrode defines a gap: Thompson et al. and Bommarito et al. discloses a having a thickness but does not disclose a particular value for this parameter. However, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide a gap electrode defines a gap ranging from about 0.01 millimeters to about 0.3 millimeters, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the “optimum range” involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
With respect to claim 9, Thompson et al. and Bommarito et al. discloses the biological indicator system of claim 7, wherein the film comprises a polymer and metal nanoparticles (see Bommarito et al. para 0039, lines 1-11).
With respect to claim 10, the combination of Thompson et al. and Bommarito et al. discloses the biological indicator system of claim 1, further comprising an array of sensing pads (both Thompson and Bommarito teach the use of multiple sensing pads arranged as an array Thompson et al. para 0042-0048).
With respect to claim 11, the combination of Thompson et al. and Bommarito et al. discloses the biological indicator system of claim 1, further comprising an array of radiofrequency indicator tags (see Bommarito et al. who teaches coupling an RF reader to a user interface such as a display, computer and handheld device; see 152, Fig. 4).
With respect to claim 12, Thompson et al. and Bommarito et al. discloses the biological indicator system of claim 1, further comprising a radiofrequency identification reader coupled to a user interface (see Thompson et al. para 0096, lines 1-7).
With respect to claim 13, Thompson et al. and Bommarito et al. discloses the biological indicator system of claim 12, wherein the radiofrequency identification reader provides power to the radiofrequency identification sensing board (see Thompson et al. para 0096, lines 1-7).
With respect to claim 14, the combination of Thompson et al. and Bommarito et al. discloses the biological indicator system of claim 12. Regarding the tag transmits data to the radiofrequency identification reader at: Thompson et al. and Bommarito et al. discloses a frequency ranging from about 300 Megahertz to about 3 Gigahertz but does not disclose a particular value for this parameter. However, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide a frequency ranging from about 300 Megahertz to about 3 Gigahertz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the “optimum range” involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
With respect to claim 15, the combination of Thompson et al. and Bommarito et al. discloses the biological indicator system of claim 12. Wherein the radiofrequency tag transmits data to the radiofrequency identification reader at a frequency ranging from about 3 Megahertz to about 30 Megahertz. However, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide a frequency ranging from about 3 Megahertz to about 30 Megahertz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the “optimum range” involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
With respect to claim 16, Thompson et al. and Bommarito et al discloses the biological indicator system of claim 1, wherein the radiofrequency identification sensing board is free of a battery (Thompson et al. Bopara 0089, lines 17-26).
With respect to claim 17, Thompson et al. and Bommarito et al discloses the biological indicator system of claim 1, further comprising a temperature sensor (see Thompson et al. para 0114, lines 1-8).
With respect to claim 18, the combination of Thompson et al. and Bommartio et al. discloses a method for determining the efficacy of a sterilization (para 0081, lines 1-6) process via a
biological indicator system (biological indicator 100 shows a sterilization cabinet with a biological indicator shown in Fig. 1); wherein the container includes a growth medium and a biological indicator (biological indicator analyzer 102 shown in Fig. 1)
Thompson et al. does not disclose a radiofrequency identification sensing board
and a radiofrequency identification reader, the method comprising:
exposing a sensing pad of the radiofrequency identification sensing board to
vapor from headspace in a container, wherein the container includes a growth
medium and a biological indicator;
measuring an impedance level or a resistance level of the sensing pad; and
sending data associated with the impedance level or the resistance level to a
radiofrequency identification tag, wherein the presence of a volatile organic
compound is determined if the impedance level or the resistance level is higher than
a predetermined baseline impedance level or baseline resistance level of the
sensing pad, wherein the presence of the volatile organic compound indicates
failure of the sterilization process.
Bommarito et al. discloses a radiofrequency identification sensing board
and a radiofrequency identification reader (while not explicitly called “RFID” the reference teaches wireless RF sensing using an antenna and resonant circuit, which is commonly considered RFID-type sensing in the art), the method comprising:
exposing a sensing pad of the radiofrequency identification sensing board to
vapor from headspace in a container (see resonant circuit 111/112, resonant frequency shifts based on impedance change and moisture alters dielectric properties which directly impacts impedance change; para 0029-0031); measuring an impedance level or a resistance level of the sensing pad ; and sending data associated with the impedance level or the resistance level to a radiofrequency identification tag, wherein the presence of a volatile organic (exposure to moisture/water vapor, water vapor being a volatile compound; para 0025) compound is determined if the impedance level or the resistance level is higher than a predetermined baseline impedance level or baseline resistance level of the sensing pad (exposure to moisture/water vapor, water vapor being a volatile compound; para 0025), wherein the presence of the volatile organic compound indicates failure of the sterilization process (exposure to moisture/water vapor, water vapor being a volatile compound; para 0025).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Thompson et al. to include a radiofrequency identification sensing board and a radiofrequency identification reader, the method comprising:
exposing a sensing pad of the radiofrequency identification sensing board to vapor from headspace in a container, wherein the container includes a growth medium and a biological indicator; measuring an impedance level or a resistance level of the sensing pad; and sending data associated with the impedance level or the resistance level to a radiofrequency identification tag, wherein the presence of a volatile organic compound is determined if the impedance level or the resistance level is higher than a predetermined baseline impedance level or baseline resistance level of the sensing pad, wherein the presence of the volatile organic compound indicates failure of the sterilization process as taught by Bommarito et al. to allow for non-invasive, wireless detection of sterilization-related biological changes without opening the biological indicator container.
With respect to claim 19, Thompson et al. and Bommarito et al. discloses the method of claim 18, further comprising transmitting the data to a radiofrequency identification reader (Thompson et al. para 0089, lines 17-26).
With respect to claim 20, Thompson et al. and Bommarito et al. discloses the method of claim 19, further comprising sending the data from the radiofrequency identification reader to a user interface (see Bommarito et al. who teaches coupling an RF reader to a user interface such as a display, computer and handheld device; see 152, Fig. 4).
With respect to claim 21, Thompson et al. and Bommarito et al. discloses the method of claim 18, further comprising measuring a temperature within the container via a temperature sensor (see Thompson et al. para 0114, lines 1-8).
With respect to claim 22, Thompson et al. discloses the method of claim 18, wherein the radiofrequency identification sensing board comprises a radiofrequency tag (see Thompson et al. while not explicitly called “RFID” the reference teaches wireless RF sensing using an antenna and resonant circuit, which is commonly considered RFID-type sensing in the art) that includes a radiofrequency integrated circuit and an antenna, a microcontroller or digital electronics , and an electrical circuit configured to measure the impedance level or the resistance level of the sensing pad (an analyzer 153 shown in Fig. 4, it’s a signal processing circuitry performing equivalent control and analysis function).
With respect to claim 23, Thompson et al. and Bommarito et al. discloses the method of claim 22, further comprising an array of radiofrequency indicator tags (while not explicitly called “RFID” the reference teaches wireless RF sensing using an antenna and resonant circuit, which is commonly considered RFID-type sensing in the art).
With respect to claim 24, Thompson et al. and Bommarito et al. discloses the method of claim 22. Thompson et al. and Bommarito et al. does not disclose wherein the radiofrequency tag transmits data to the radiofrequency identification reader at a frequency ranging from about 300 Megahertz to about 3 Gigahertz. However, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide a wherein the radiofrequency tag transmits data to the radiofrequency identification reader at a frequency ranging from about 300 Megahertz to about 3 Gigahertz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the “optimum range” involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
With respect to claim 25, Thompson et al. and Bommarito et al. discloses the method of claim 22. Thompson et al. and Bommarito et al. does not disclose wherein the radiofrequency tag transmits data to the radiofrequency identification reader at a frequency ranging from about 3 Megahertz to about 30 Megahertz. However, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide a wherein the radiofrequency tag transmits data wherein the radiofrequency tag transmits data to the radiofrequency identification reader at a frequency ranging from about 3 Megahertz to about 30 Megahertz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the “optimum range” involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
With respect to claim 26, Thompson et al. and Bommarito et al. discloses the method of claim 18, wherein a cap seals the radiofrequency identification sensing board, the biological indicator, and the growth medium within the container. Thompson et al. and Bommarito et al. does not disclose wherein a headspace distance between the growth medium and the radiofrequency identification sensing board ranges from about 4 millimeters to about 16 millimeters. However, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide a wherein the radiofrequency tag transmits data wherein a headspace distance between the growth medium and the radiofrequency identification sensing board ranges from about 4 millimeters to about 16 millimeters, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the “optimum range” involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
With respect to claim 27, the combination of Thompson et al. and Bommarito et al. discloses the method of claim 18, wherein a filter is disposed between the radiofrequency identification sensing board and the growth medium (see Thompson et al. showing a biological indicator assembly with a liquid growth medium fluid 732, Fig. 19; para 0129, lines 9-16).
With respect to claim 28, the combination of Thompson et al. Bommarito et al. discloses the method of claim 27. Thompson et al. and Bommarito et al. does not disclose wherein the filter includes a polymer coating having a thickness ranging from about 0.1 micrometers to about 5 micrometers. However, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide wherein the filter includes a polymer coating having a thickness ranging from about 0.1 micrometers to about 5 micrometers, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the “optimum range” involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
With respect to claim 29, the combination of Thompson et al. and Bommarito et al. discloses the method of claim 18, wherein the sensing pad is in contact with a gap electrode or an interdigitated electrode coated with a film comprising a polymer and metal nanoparticles (see sensor 840 which is considered the gap electrode Fig. 20).
With respect to claim 30, the combination of Thompson et al. and Bommarito et al. discloses the method of claim 29. Thompson et al. and Bommarito et al. does not disclose wherein the gap electrode defines a gap ranging from about 0.01 millimeters to about 0.3 millimeters. However, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide wherein the gap electrode defines a gap ranging from about 0.01 millimeters to about 0.3 millimeters, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the “optimum range” involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
With respect to claim 31, the combination of Thompson et al. and Bommarito et al. discloses the method of claim 18, wherein the radiofrequency identification
sensing board includes an array of sensing pads (see Bommarito et al. moisture absorbing layer/sensor structure 110 positioned to interact with sterilized articles. Changes electrical behavior when exposed to moisture; the moisture absorbing layer 130 shown in Fig. 4; para 0029, lines 1-7).
With respect to claim 32, the combination of Thompson et al. and Bommarito et al. discloses the method of claim 18, wherein the radiofrequency identification reader is coupled to a user interface (see Bommarito et al. who teaches coupling an RF reader to a user interface such as a display, computer and handheld device; see 152, Fig. 4).
With respect to claim 33, the combination of Thompson et al. and Bommarito et al. discloses the method of claim 18, wherein the radiofrequency identification reader provides power to the radiofrequency identification sensing board (see Bommarito et al. para 0047, lines 13-21).
With respect to claim 34, the combination of Thompson et al. and Bommarito et al. discloses the method of claim 18, wherein the radiofrequency identification sensing board is free of a battery (Thompson et al. Bopara 0089, lines 17-26).
With respect to claim 35, the combination of Thompson et al. and Bommarito et al. discloses the method of claim 18, wherein the sterilization process utilizes steam, hydrogen peroxide, or ethylene oxide (see Bommarito et al. para 0023, lines 1-10).
Conclusion
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/FARHANA A HOQUE/ Primary Examiner, Art Unit 2858