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 .
Information Disclosure Statement
The information disclosure statement filed 8/15/2022 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the NPL line item 1 does not have an attached copy. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
The disclosure is objected to because of the following informalities:
On Page 8, Paragraph [0028], line 6, “digestive tract 34” should read “digestive tract 32”.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Unnumbered claim after claim 15 should be numbered claim 16 and has been for examination purposes.
Claims 1-2, 8-10, 12-13, and 16 are objected to because of the following informalities:
In Claims 1, line 2 and Claim 2, line 1, “said capsule” should read “said blast capsule”.
In Claims 1, line 8, “senor” should read “sensor”.
In Claim 2, line 4, “contained adapted” should read “
In Claim 8, line 1, “contains” should read “contain”.
In Claim 8, line 2, “turn on” should read “turns on”.
In Claim 9, line 1, “switch” should read “switches”.
In Claim 10, line 2, “via” should read “using”.
In Claim 12, line 1, “continuous monitoring internal pressure” should read “continuously monitoring internal pressure” or “continuous monitoring of internal pressure”
In Claim 12, line 4, “a subject” should read “the subject”.
In Claim 12, line 4, “a blast capsule” should read “the blast capsule” or “said blast capsule”.
In Claim 13, line 1, “programed” should read “programmed”.
In Claim 16, line 2, “rate of 1 at least 1 megasample per second” should read “rate of [1] at least 1 megasample per second”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “electronics module” in claims 1, 7-10, and 12-15.
Claim 1 reciting “whereas said electronics module controls the operation of the blast capsule and records pressure data taken by said pressure sensor”. The limitation “electronics module” has been interpreted under 112f as a mean plus function limitation because of the combination of a non-structural generic placeholder term “module” and functional language “controls the operation of the blast capsule and records pressure data taken by said pressure sensor” without reciting sufficient structure to achieve the function.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Paragraph [0031] described sufficient structure to further define the electronics module as a microcontroller: “the electronic module may comprise a microcontroller (MCU)”.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “b) a pressure sensor contained adapted to measure overpressure caused by a blast”. It is unclear if “a blast” is referring to the blast in the preamble of Claim 1 or a different blast. For examination purses, Claim 1 will be read as referring to the same blast from the preamble of Claim 1.
Claim 1 recites “said capsule comprising a housing having a) a power supply; b) a pressure sensor contained adapted to measure overpressure caused by a blast; and c) an electronics module operatively connected to the power supply and the pressure sensor”. It is unclear if the capsule or the housing has the power supply, pressure sensor, and electronics module components. It is further unclear by the use of the word “having” if the components are contained within the capsule or the housing. For examination purposes, Claim 1 will be read as referring to the capsule comprising a housing and being operatively connected to a power supply.
Claim 1 recites “whereas said electronics module controls the operation of the blast capsule”. It is unclear what the functionality of the electronics module is relative to due to the use of the term “whereas”. For examination purposes, Claim 1 will be read as “wherein said electronics module controls the operation of the blast capsule”.
Claim 1 recites “said electronics module controls the operation of the blast capsule”. There is insufficient antecedent basis for the limitation “the operation” in the claim. For examination purposes, Claim 1 will be read as the electronics module controlling operation of the blast capsule”.
Claim 5 recites “wherein said pressure sensor is capable of measuring high energy and high frequency pressures associated with a blast”. It is unclear if “a blast” is referring to the blast in the preamble of Claim 1 or a different blast. For examination purses, Claim 5 will be read as referring to the same blast from the preamble of Claim 1.
Claim 5 recites “wherein said pressure sensor is capable of measuring high energy and high frequency pressures associated with a blast”. The term “high” is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is further unclear how energy is related to a blast or explosion, whether indicating a certain strength of blast or rapid increase of pressure associated with a blast or explosion. For examination purposes, Claim 5 will be read as the pressure sensor being capable of measuring pressure of any frequency that is associated with a blast.
Claim 6 recites “wherein said pressure sensor is measuring pressure”. It is unclear if the Applicant is intending to recite active method steps within an apparatus claim. For examination purposes, Claim 6 will be read as wherein the pressure sensor is configured to measure pressure.
Claim 8 recites “wherein said electronics module may further contains an activation switch”. It is unclear if the claimed invention requires an activation switch or not. For examination purposes, Claim 8 will be read as said electronics module further contains an activation switch.
Claim 12 recites “d) measuring and recording internal pressures inside the subject during a blast or explosion”. It is unclear if “a blast” is referring to the blast in the preamble of Claim 12 or a different blast or explosion. For examination purses, Claim 12 will be read as referring to the same blast from the preamble of Claim 12.
Claim 12 recites “e) transmitting said measurements to a remote computer or electronic device”. There is insufficient antecedent basis for the limitation “said measurements” in the claim. It is unclear if the measurements are referring to the measured internal pressure or another measurement. For examination purposes, Claim 12 will be read as referring to measured internal pressures.
Claim 13 recites “wherein said electronics module is programed to control the sampling rate”. There is insufficient antecedent basis for the limitation “the sampling rate” in the claim. For examination purposes, Claim 13 will be read as referring to said electronics controlling a sampling rate.
Claim 13 recites “The method of claim 12, wherein said electronics module is programed to control the sampling rate of said sensor”. There is insufficient antecedent basis for the limitation “said sensor” in the claim. It is unclear if “said sensor” refers to the pressure sensor of Claim 1 since there is not mention of a sensor in Claim 12 from which this limitation is dependent. For examination purposes, Claim 13 will be read as referring to the pressure sensor of Claim 1.
Claim 14 recites “The method claim of claim 12, wherein said electronics module is programmed to control a transmission burst duration and a rate of transmission bursts of said transmitter.” There is insufficient antecedent basis for the limitation “said transmitter” in the claim. For examination purposes, Claim 14 will be read as the said electronics module being programmed to control a transmission burst duration and a rate of transmission bursts of any transmitter.
Claim 14 recites “wherein said electronics module is programmed to control a transmission burst duration”. It is unclear if the transmission burst duration refers to the time length of transmitting data or the time length of data being transmitted. For examination purposes, Claim 14 will be read as referring to a time length of transmitting data during a burst.
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 1-2, 4-5, 8, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. PG Publication No. US10624312B2 to Breitenstein (as cited on IDS filed 8/15/2022) in view of US PG Publication No. US20210113099A1 to Rogers, et al. (hereainafter, Rogers).
Regarding Claim 1, Breitenstein discloses a blast capsule (Figure 1, bolus-shaped body 14, Page 7, Colum 3, line 64, The body is for example in the form of a pill) for monitoring internal pressure experienced by a subject (Page 7, Column 3, lines 16-17, In the stomach, it can detect gastric pressure and the movements of the stomach, Examiner notes detecting gastric pressure of a subject’s stomach as monitoring internal pressure),
said capsule comprising a housing (Figure 1 depicts casing 1 of region 102 and casing 7 of region 101 with membrane 5 top secured by ring 6; Page 7, Column 3, The body, or optionally bolus for short, can be encapsulated with a polymer (for example epoxy resin), Examiner notes encapsulation by adjoining casings and membrane polymer as a housing containing the battery 2, pressure sensor 9, and microcontroller 10 of Figure 1) having
a) a power supply (Figure 1, battery 2);
b) a pressure sensor (Figure 1, pressure sensor 9); and
c) an electronics module operatively connected to the power supply (Examiner notes an energy source in the form of a battery 2 for supplying the electronics 4 as described on Page 10, Column 10, lines 2-3; wherein the electronics 4 comprise a pressure sensor 9 and a microcontroller 10 as described on Page 10, Column 9, lines 43-45; Examiner notes the battery supplying energy to the electronics inclusive of the microcontroller as indicating operative connection between the two components) and the pressure sensor (Page 10, Column 9, lines 59-62, The electronics 4 are internally interconnected in such a way that the measurement data from the pressure sensor 9 can be processed by the microcontroller 10, Examiner notes microcontroller processing pressure measurement data as indicating operative connection with the pressure sensor).
whereas said electronics module controls the operation of the blast capsule and records pressure data taken by said pressure sensor (Page 8, Column 6, lines 10-20, the sensor or sensors are in direct contact with the telemetric device of the body, which device, preferably with the assistance of a microcontroller, transmits the results to a base station … It is likewise possible to process the data as early as on the microcontroller in the device, the microcontroller in particular converting, saving or time-stamping these data and/or transmitting them to the telemetric device, Examiner notes the microcontroller processing measurements and transmitting results as controlling operation of the blast capsule, and processing measurements by saving or time-stamping data as recording pressure data).
However, Breitenstein doesn’t teach monitoring pressure from a blast and the pressure sensor adapted to measure overpressure caused by a blast.
Rogers teaches monitoring pressure experienced by a subject from a blast and the pressure sensor adapted to measure overpressure caused by a blast (Examiner notes the sensor system may comprise a pressure sensor as described in Paragraph [0050], lines 6-7; wherein the sensor can be deployed directly on the user and can be used to assess the severity of an impact of mechanical waves from an explosion as described in Paragraph [0213], lines 1-9; Examiner notes explosion mechanical waves as overpressure from a blast and the sensor system including a pressure sensor being deployed directly on the subject as indicating monitoring pressure experienced by a subject).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pressure sensor of Breitenstein for the pressure sensor of Rogers because the substitution of art recognized equivalents as shown by Rogers is within the level or ordinary skill in the art. In addition, the substitution of one pressure sensor for another is likely to be obvious when it does not more than yield predictable results. Doing so would allow for an assessment of the proximity of the user to a blast and the likelihood of damage to a vital organ, as recognized by Rogers (Paragraph [0213], lines 3-7, The sensor can be used to assess the severity of such an impact as a way to non-invasively assess a bullets impact or proximity of the user to a blast. The sensor can also be used to assess the likelihood of damage to a vital organ).
Regarding Claim 2, Breitenstein as modified by Rogers teaches the blast capsule of claim 1, wherein said capsule is sized and adapted to be ingested by or implanted inside the subject (Breitenstein: Examiner notes a sensor system is introduced orally into the rumen in bolus form as described on Page 6, Column 1, lines 40-41; wherein the rumen is one of a plurality of stomachs in a ruminant animal as descried on Page 7, Column 3, lines 9-12; Examiner notes the bolus as capsule, and oral introduction into a stomach of a subject as indicating the bolus is ingestible).
Regarding Claim 4, Breitenstein as modified by Rogers teaches the blast capsule of claim 2, wherein said housing is waterproof (Breitenstein: Page 7, Column 9, lines 61-63, The body, or optionally bolus for short, can be encapsulated with a polymer (for example epoxy resin) and is preferably watertight, Examiner notes watertight as waterproof).
Regarding Claim 5, Breitenstein as modified by Rogers teaches the blast capsule of claim 1, wherein said pressure sensor is capable of measuring high energy and high frequency pressures associated with a blast (Rogers: Examiner notes the sensor system may comprise a pressure sensor as described in Paragraph [0050], lines 6-7; wherein the sensor can be used to assess the severity of an impact of mechanical waves from an explosion as described in Paragraph [0213], lines 1-9; Examiner notes the sensor system including a pressure sensor measuring explosion mechanical waves as indicating capability of measuring high energy and high frequency pressures associated with a blast).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pressure sensor of Breitenstein for the pressure sensor of Rogers because the substitution of art recognized equivalents as shown by Rogers is within the level or ordinary skill in the art. In addition, the substitution of one pressure sensor for another is likely to be obvious when it does not more than yield predictable results. Doing so would allow for an assessment of the proximity of the user to a blast and the likelihood of damage to a vital organ, as recognized by Rogers (Paragraph [0213], lines 3-7, The sensor can be used to assess the severity of such an impact as a way to non-invasively assess a bullets impact or proximity of the user to a blast. The sensor can also be used to assess the likelihood of damage to a vital organ).
Regarding Claim 8, Breitenstein as modified by Rogers teaches the blast capsule of claim 1, wherein said electronics module may further contains an activation switch, which turn on the blast capsule (Breitenstein: Page 10, Column 10, lines 4-7, The electronics 4 are activated by means of a latching circuit which is triggered with a reed contact. To this end, magnet closes the reed contact from outside and so activates the electronics 4, Examiner notes reed switch circuit as indicating the electronics module includes an activation switch, and closing the reed contact as indicating activation by reed switch).
Regarding Claim 10, Breitenstein as modified by Rogers teaches the blast capsule of claim 1, wherein said electronics module records measurements provided by said pressure sensor (Breitenstein: Page 8, Column 6, lines 16-20, It is likewise possible to process the data as early as on the microcontroller in the device, the microcontroller in particular converting, saving or time-stamping these data and/or transmitting them to the telemetric device, Examiner notes the microcontroller processing measurements by saving or time-stamping data as recording pressure data) and transmits the measurements to a computer (Breitenstein: Examiner notes the data determined by the sensor is transmitted to a base station by telemetry as described on Page 8, Column 6, lines 39-43; wherein the data from the base station can be processed by a computer and displayed as described on Page 8, Column 6, lines 44-47; Examiner notes the processing of data by a computer to include transmission of said data to the computer) via wire or wireless communications (Breitenstein: Examiner notes the data determined by the pressure sensor are transmitted to the base station with the assistance of the telemetric device as described on Page 8, Column 6, lines 27-32; wherein the data determined by the sensor is transmitted to a base station by telemetry as described on Page 8, Column 6, lines 39-43; Examiner notes telemetry as wireless communication).
Regarding Claim 11, Breitenstein as modified by Rogers teaches the blast capsule of claim 1, wherein said power supply comprises a battery (Breitenstein: Page 9, Columns 9-10, lines 66-2, The second region 102 has a cylindrical casing 1 (for example of a stainless steel) which comprises an energy source in the form of a battery 2).
Regarding Claim 12, Breitenstein as modified by Rogers teaches a method (Breitenstein: Page 6, Column 1, lines 20-21, A method for measuring gastric pressure in livestock) for continuous monitoring (Breitenstein: Page 7, Column 3, lines 25-27, it is possible to achieve periods of operation of a number of months and even years using this device, Examiner notes device use over months and years as continuous monitoring) internal pressure changes experienced by a subject (Breitenstein: Page 10, Column 9, lines 54-56, Deformation of the membrane 5 as a result of application of force brings about a change in pressure in the gas-tight interior 12 which can be detected by the pressure sensor 9, Examiner notes detecting gastric pressure of a subject’s stomach as monitoring internal pressure of a subject) during a blast (Rogers: Examiner notes the sensor system may comprise a pressure sensor as described in Paragraph [0050], lines 6-7; wherein the sensor can be deployed directly on the user and can be used to assess the severity of an impact of mechanical waves from an explosion as described in Paragraph [0213], lines 1-9; Examiner notes explosion mechanical waves as pressure from a blast and the sensor system including a pressure sensor being deployed directly on the subject as indicating monitoring pressure experienced by a subject), comprising:
a) providing a blast capsule of claim 1 (See Claim 1 mapping above);
b) having the subject ingest or implanting inside a subject a blast capsule of claim 1 (Breitenstein: Page 9, Column 7, lines 66-67, preferably orally introducing the device into the stomach of the livestock animal);
c) activating said blast capsule (Breitenstein: Page 10, Column 10, lines 4-7, The electronics 4 are activated by means of a latching circuit which is triggered with a reed contact. To this end, magnet closes the reed contact from outside and so activates the electronics 4, Examiner notes closing the reed contact as indicating activation of the blast capsule by reed switch since it activates the electronics of the blast capsule)
d) measuring (Breitenstein: Page 7, Column 3, lines 16-17, In the stomach, it can detect gastric pressure and the movements of the stomach, Examiner notes detecting gastric pressure of a subject’s stomach as measuring internal pressure of a subject) and recording internal pressures inside the subject during a blast or explosion (Breitenstein: Page 10, Column 9, lines 59-62, The electronics 4 are internally interconnected in such a way that the measurement data from the pressure sensor 9 can be processed by the microcontroller 10, Examiner notes the microcontroller processing pressure measurements as recording internal pressure data since the microcontroller is receiving the data from the pressure sensor); and
e) transmitting said measurements to a remote computer or electronic device (Breitenstein: Examiner notes the data determined by the sensor is transmitted to a base station by telemetry as described on Page 8, Column 6, lines 39-43; wherein the data from the base station can be processed by a computer and displayed as described on Page 8, Column 6, lines 44-47; Examiner notes the processing of data by a computer to include transmission of said data to the computer).
Regarding Claim 13, Breitenstein as modified by Rogers teaches wherein said electronics module is programed to control the sampling rate of said sensor (Breitenstein: Page 7, Column 4, lines 23-28, The energy supply and energy management of the device according to the invention are in particular designed such that active operation of the device, i.e. for example intermittent or periodic measurements by the sensors of device and telemetric transmission of the measurement data to a receiver, is possible for a period of at least one year, Examiner notes periodic measurements by the sensors as indicating a sampling rate inherently controlled by the electronics module timing).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Breitenstein as modified by Rogers as applied to claims 1-2 above, and further in view of U.S. Patent No. US6929636B1 to von Alten (as cited on IDS filed 8/15/2022).
Regarding Claim 3, Breitenstein as modified by Rogers teaches the blast capsule of claim 2. Breitenstein as modified by Rogers does not teach wherein said housing is made of an inert material.
Von Alten teaches a capsule housing made of an inert material (Page 10, Column 5, lines 27-29, Capsule 10, particularly its shell, preferably is made of (or coated with) one or more of the following inert materials: Teflon; glass; ceramic; and other materials known to those skilled in the art).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the housing of Breitenstein to be made of an inert material. Doing so would allow for repeated use for subsequent procedures, as recognized by von Alten (Page 8, Column 1, lines 34-35, Since the capsule is inert, i.e. non-digestible, the capsule can be reused for subsequent procedures).
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Breitenstein as modified by Rogers as applied to claims 1 and 5, 12 and 13 above, and further in view of Rude, et al., Performance Evaluation of the Roach Cove Bubble Screen Apparatus (U), April 2007, Technical Memorandum DRDC Suffield TM 2007-046 (hereinafter, Rude).
Regarding Claims 6 and 16, Breitenstein as modified by Rogers teaches the blast capsule of claim 5 and the method of claim 13, wherein said blast capsule measures and records internal pressures inside the subject (Breitenstein: Examiner notes the electronics 4 are internally interconnected in such a way that the measurement data from the pressure sensor 9 can be processed by the microcontroller 10 as described on Page 10, Column 9, lines 59-62; and gastric pressure can be detected in the stomach as described on Page 7, Column 3, lines 16-17; Examiner notes detecting gastric pressure of a subject’s stomach as measuring internal pressure of a subject and the microcontroller processing pressure measurements as recording pressure data since the microcontroller is receiving the data from the pressure sensor). However, Breitenstein as modified by Rogers does not teach the blast capsule measuring and recording pressures at a sampling rate of 1 at least 1 megasample per second (1 MSPS).
Rude teaches measuring at a sampling rate of at least 1 megasample per second (1 MSPS) (Page 12, Paragraph 1, lines 4-5, Five M samples/s is the recommended sampling rate to ensure capture of the highest frequencies with acceptable accuracy).
The motivation to combine the low power operation and switching to a sleep state teachings of Maile applies to Claims 6 and 16. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sampling rate of the blast capsule, and specifically the pressure sensor, of Breitenstein to measure and record internal pressures inside the subject at a frequency of at least 1 MSPS. Doing so would ensure capture of the highest frequencies with acceptable accuracy, as recognized by Rude (Page 12, Paragraph 1, lines 2-5, In order to capture up to the 1 MHz frequency content, the Nyquist sampling frequency must be considerably exceeded if the higher frequency components are to be properly resolved. Five M samples/s is the recommended sampling rate to ensure capture of the highest frequencies with acceptable accuracy).
Claims 7, 9, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Breitenstein as modified by Rogers as applied to claims 1 and 12 above, and further in view of US Patent No. US7650185B2 to Maile, et al. (hereinafter, Maile).
Regarding Claim 7, Breitenstein as modified by Rogers teaches the blast capsule of claim 1. However, Breitenstein as modified by Rogers does not teach wherein said electronics module is designed to operate with a low power consumption.
Maile teaches a medical device operating with a low power consumption (Page 11, Column 3, lines 49-54, In order to achieve this low power consumption, the satellite IMD 104 is normally in a “sleep” or “sleeping” state characterized by a power consumption of from essentially zero (i.e., a completely powered off state) to a low power state in which only a minimal circuitry (e.g., a timer or comparator) are energized and consuming electrical power).
Regarding Claim 9, Breitenstein as modified by Rogers teaches the blast capsule of claim 1. However, Breitenstein as modified by Rogers does not teach the electronics module switch blast capsule into a sleep state during non-recording period to conserve power.
Maile teaches the electronics module switch blast capsule into a sleep state during non-recording period to conserve power (Examiner notes the satellite IMD 104 is desirably in the active state only to the extent necessary to perform its designated diagnostic and/or therapeutic function(s), after which time it returns to its sleep state as described on Page 11, Column 4, lines 2-5; wherein the designated functions includes taking one or more measurements as described on Page 11, Column 3, lines 18-20; and wherein the sleep state conserves energy as described on Page 13, Column 8, lines 8-10, Examiner notes active state as indicating measurement recording period and returning to a sleep state to conserve power as non-recording period).
Regarding Claim 15, Breitenstein as modified by Rogers teaches the method of claim 12, wherein said electronics module is configured to activate the blast capsule (Breitenstein: Page 10, Column 10, lines 4-7, The electronics 4 are activated by means of a latching circuit which is triggered with a reed contact. To this end, magnet closes the reed contact from outside and so activates the electronics 4, Examiner notes closing the reed contact as indicating activation of the blast capsule by reed switch since it activates the electronics of the blast capsule) to record pressure data inside the subject (Breitenstein: Examiner notes the electronics 4 are internally interconnected in such a way that the measurement data from the pressure sensor 9 can be processed by the microcontroller 10 as described on Page 10, Column 9, lines 59-62; and gastric pressure can be detected in the stomach as described on Page 7, Column 3, lines 16-17; Examiner notes detecting gastric pressure of a subject’s stomach as measuring pressure inside a subject and the microcontroller processing pressure measurements as recording pressure data since the microcontroller is receiving the data from the pressure sensor). However, Breitenstein as modified by Rogers does not teach the electronics module being explicitly programmed to activate the blast capsule.
Maile teaches an electronics module programmed to activate a medical device (Examiner notes circuitry within the wake-up sensor triggers the wake-up of at least the satellite IMD controller 272, the physiologic sensor 278, and/or the communication module 284 via the power control circuitry 258 as described on Page 13, Column 7, lines 37-42; wherein the physiologic sensor performs pressure measurements in the artery as described on Page 13, Column 7, lines 59-62, Examiner notes the power control circuitry as electronics module and waking up of the satellite IMD controller, physiologic sensor and communication module as activating the device for internal pressure recording of a subject).
The motivation to combine the low power operation and switching to a sleep state teachings of Maile applies to Claims 7, 9, and 15. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electronics module of Breitenstein to operate with low power consumption, to switch the blast capsule into a sleep state during non-recording periods to conserve power and to be programmed to activate the blast capsule to record pressure data inside the subject. Doing so would maximize the longevity of the device by minimizing its power consumption, as recognized by Maile (Page 11, Column 3, lines 38-41, In an effort to maximize the longevity of the satellite IMD 104, its power consumption is minimized, and thus, the average power consumption of the satellite IMD 104 is desirably very low).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Breitenstein as modified by Rogers as applied to claim 12 above, and further in view of U.S. PG Publication No. US20160360994A1 to Rettedal, et al. (hereinafter, Rettedal).
Regarding Claim 14, Breitenstein as modified by Rogers teaches the method of claim 12, wherein said electronics module is programmed to control rate of transmission bursts of said transmitter (Breitenstein: Page 8, Column 6, lines 30-33, The data determined by the pressure sensor… are preferably saved in a memory integrated in the device and, either at defined intervals or when queried, transmitted to the base station with the assistance of the telemetric device, Examiner notes transmitting data at defined intervals as indicating rate of transmission bursts inherently controlled by the electronics module). However, Breitenstein as modified by Rogers does not teach the electronics module being programmed to control a transmission burst duration.
Rettedal teaches a device controlling transmission burst duration (Paragraph [0058], lines 36-38, limiting the duration of the transmission burst (56) only to that period of time necessary to transmit the limited amount of encoded physiological data (19), Examiner notes limiting the duration of the transmission burst as controlling a transmission burst duration because it is setting a maximum duration).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electronics module of Breitenstein to be programmed to control a transmission burst duration. Doing so would increase the operating lifespan of the device, as recognized by Rettedal (Paragraph [0058], lines 34-40, Because the majority of energy (42) used by the bolus (1) is in operation of the radio signal generator (21), increasing the time period between transmission bursts (56) and limiting the duration of the transmission burst (56) only to that period of time necessary to transmit the limited amount of encoded physiological data (19) can substantially increase the operating lifespan of the bolus (1)).
Conclusion
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/DAKOTA R. SABOTKA/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791