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 .
Election/Restrictions
Claims 1-6 are rejoined since they have been amended to read on the elected species B2.
Claim 18 is withdrawn for being drawn to the non-elected species of A2.
Claim 17 is withdrawn for being drawn to the non-elected species of C1.
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: “an audio output unit” in claim 19.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
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 Objections
Claims 6 and 20 are objected to because of the following informalities:
in claim 6, line 2: “determining-includes” should be “determining includes”;
in claim 20, line 4: “the” should be inserted before “presentation”.
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.
Claim 1-6 and 10 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 “the programmed pattern” in line 13 in which there is insufficient antecedent basis for this limitation in the claim. Also, it is not clear what “the programmed pattern” is referring to in the context of the claim language.
Claims 2-6 are rejected by virtue of their dependence from claim 1.
Claim 2 recites “a seizure” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a seizure” in claim 1, line 11. If they are the same, “a seizure” in claim 2 should be “the seizure”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 2 recites “wherein the high-frequency changes are determined to be representative of a seizure in response to a determination that the high-frequency changes match a predefined pattern” in lines 1-3, but it is not clear if these determinations are the same as, related to, or different from “determining that the human body is experiencing a seizure” in claim 1, line 11. The relationship among these determinations should be made clear.
Claims 3-4 are rejected by virtue of their dependence from claim 2.
Claim 5 recites “patterns of the high-frequency changes that are representative of seizures” in lines 2-3, but it is not clear if these patterns are the same as, related to, or different from “detected patterns…of the high-frequency changes” of claim 1, lines 11-12. The relationship between these recitations should be made clear.
Related to the immediately preceding paragraph, it is not clear if “seizures” in claim 5, line 3 is the same as, related to, or different from “a seizure” of claim 1, line 11. Clarification is required.
Claim 6 recites “an interval of time” in line 3, but it is not clear if this recitation is the same as, related to, or different from “a period of time” in claim 1, line 8. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear.
Claim 10 recites “patterns and magnitudes of high-frequency changes that are representative of seizures” in lines 2-3, but it is not clear if this recitation is the same as, related to, or different from “patterns and magnitudes of the high-frequency changes” of claim 7, lines 15-16. The relationship between these two recitations should be made clear.
Related to the immediately preceding paragraph, it is not clear if “high-frequency changes” in claim 10, lines 2-3 is the same as, related to, or different from “high-frequency changes” of claim 7, line 13. Clarification is required.
Also, it is not clear if “seizures” in claim 10, line 3 is the same as, related to, or different from “a seizure” of claim 7, line 15. Clarification is required.
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.
Claims 14-15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0164677 (Squitieri)(previously cited), in view of U.S. Patent Application Publication No. 2015/0008710 (Young)(previously cited), and further in view of U.S. Patent Application Publication No. 2008/0000477 (Huster)(previously cited).
Squitieri teaches a method performed by a controller (the control system 130 of Squitieri) comprising: a structural body that includes a first fluid interface (the connector for the pump 132 of Squitieri; paragraphs 0080 and 0083 of Squitieri) to which a pump (the pump 132 of Squitieri) is fluidly couplable and a second fluid interface (the connector for the multi-channel tubing 135 of Squitieri; paragraphs 0080 and 0082 of Squitieri) to which a pressure-mitigation device (the pressure mitigation support device 120 of Squitieri) with a plurality of chambers (the independently pressurized relief chambers of Squitieri; paragraphs 0007, 0018-0019, 0026, 0057, 0062-0064, and 0068 of Squitieri) is fluidly couplable. The method of Squitieri comprises the steps of causing, by the controller, the plurality of chambers to be independently inflated to varying degrees in accordance with a programmed pattern (paragraphs 0080 and 0099 of Squitieri), in response to a determination that the pressure-mitigation device is disposed between the human body in a supine position and a surface (paragraphs 0099 and 0167 of Squitieri); and receiving, by the controller, data that is representative of a temporal series of measurements generated by a plurality of pressure sensors in the pressure-mitigation device (paragraphs 0060, 0099, and 0193 of Squitieri), wherein each pressure sensor of the plurality of pressure sensors is responsible for monitoring pressure of a corresponding chamber of the pressure-mitigation device in real time (paragraphs 0060, 0099, and 0193 of Squitieri), and outputting a corresponding subset of the measurements to indicate the pressure of the corresponding chamber (paragraphs 0060, 0099, and 0193 of Squitieri).
Young teaches the use of processors and memories (paragraphs 0024, 0028, and 0045 of Young) for parsing data to identify patterns of the measurements that are indicative of movements of the human body (parsing the data from the pressure sensors; abstract, paragraphs 0003-0005, 0019, 0026-0027, 0030, 0033, 0037, 0039-0041, 0049, 0057-0059, 0061, and 0063 of Young); determining various vital and health indicators including position, heart rate, respiration rate, sleepiness, length of sitting episodes, movement of the trunk or limbs, blood pressure, presence or lack of presence of subject, identity of subject, weight of subject, vertical position, turning or rolling movements, sedentary state, fitness level, and cardiovascular condition (the abstract, paragraphs 0003-0005, 0019, 0026-0027, 0030, 0033, 0037, 0039-0041, 0049, 0057-0059, 0061, and 0063 of Young); and generating an audio notification that specifies the various vital and health indicators that are a potential problem or need for a change to a display (paragraph 0030-0031, 0033, and 0061-0063 of Young). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the processors and memories for performing the steps of parsing, determining, and generating notification of Young so as to identify potential problems or need for a change in various vital and health indictors and generate audio notifications of such problems or needs for change so as to address potential health problems as they occur or prevent potential health problems before they occur.
Young teaches that the determination of various vital and health indicators including position, heart rate, respiration rate, sleepiness, length of sitting episodes, movement of the trunk or limbs, blood pressure, presence or lack of presence of subject, identity of subject, weight of subject, vertical position, turning or rolling movements, sedentary state, fitness level, and cardiovascular condition (the abstract, paragraphs 0003-0005, 0019, 0026-0027, 0030, 0033, 0037, 0039-0041, 0049, 0057-0059, 0061, and 0063 of Young) can be done using pattern recognition (paragraphs 0027, 0040, and 0049 of Young). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include pattern recognition when identifying various vital and health indicators including position, heart rate, respiration rate, sleepiness, length of sitting episodes, movement of the trunk or limbs, blood pressure, presence or lack of presence of subject, identity of subject, weight of subject, vertical position, turning or rolling movements, sedentary state, fitness level, and cardiovascular condition since a mechanism for making such an identification is required and Young teaches one such identification and/or it is a simple substitution of one known element for another to obtain predictable results.
Huster teaches that the same controller housing may encompass the pumping system and the diagnostic system (FIGS. 12-13 and paragraphs 0005, 0048, 0115, 0124-0125, 0141-0142, and 0151 of Huster). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the capabilities for performing the steps of parsing, determining, and generating the audio notification of Young in the controller, as suggested by Huster, since it would make the system more compact.
Further, Young teaches the placement of pressure sensors inside the inflatable chambers (abstract and paragraphs 0003-0005 and 0022-0023 of Young). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the pressure sensors inside the inflatable chambers, as suggested by Young, rather than building them into the side support portions because it is a simple substitution of one known element for another to obtain predictable results.
The combination teaches the use of the pressure-mitigation device with a pressure device 132 and connectors for attachment of the multi-channel tubing 135 to the control system (paragraph 0080 of Squitieri). Huster teaches the use of Hall effect sensors at ports at the surface of the controller to detect the presence of a magnet attached to an end of a hose so as to confirm the coupling of the hose to its connector at the surface of the controller (paragraph 0151 of Huster). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Hall effect sensors at ports at the surface of the control system 130 to detect the presence of magnets attached to the multi-channel tubing 135, as suggested by Huster, since it confirms the attachment of the coupling of the multi-channel tubing 135 to the control system 130.
With respect to claim 14, the combination teaches or suggests a controller for managing fluid flow into a pressure-mitigation device (the pressure mitigation support device 120 of Squitieri) that has a plurality of chambers (the independently pressurized relief chambers of Squitieri; paragraphs 0007, 0018-0019, 0026, 0057, 0062-0064, and 0068 of Squitieri) intertwined in a geometric shape, the controller comprising:
a structural body (the housing of the modified control system 130 of Squitieri) that includes a fluid interface (the connector for the pump 132 of Squitieri; paragraphs 0080 and 0083 of Squitieri) to which the pressure-mitigation device is fluidly couplable via multi-channel tubing (the multi-channel tubing 135 of Squitieri);
a processor (the processors of Squitieri/Young; see paragraphs 0083, 0139, and 0141 of Squitieri); and
a memory (the memories of Squitieri/Young; see paragraphs 0083, 0139, and 0141 of Squitieri) that includes instructions that, when executed by the processor, cause the controller to:
cause the plurality of chambers to be independently inflated to varying degrees in accordance with a programmed pattern (paragraphs 0080 and 0099 of Squitieri), in response to a determination that the pressure-mitigation device is disposed between a human body in a supine position and a surface (paragraphs 0099 and 0167 of Squitieri);
obtain data that is indicative of pressure of each of the plurality of chambers over time (obtaining data from the pressure sensors; paragraphs 0060, 0099, and 0193 of Squitieri), wherein each of the plurality of pressure sensors is associated with a corresponding one of the plurality of chambers and a corresponding subset of the measurements (paragraphs 0060, 0099, and 0193 of Squitieri; abstract and paragraphs 0003-0005 and 0022-0023 of Young),
examine the data in comparison to expected pressures of the plurality of chambers based the programmed pattern, so as to establish whether a criterion has been met relating to movement of the human body (parsing the data from the pressure sensors; abstract, paragraphs 0003-0005, 0019, 0026-0027, 0030, 0033, 0037, 0039-0041, 0049, 0057-0059, 0061, and 0063 of Young; the use of pattern recognition when identifying various vital and health indicators including position, heart rate, respiration rate, sleepiness, length of sitting episodes, movement of the trunk or limbs, blood pressure, presence or lack of presence of subject, identity of subject, weight of subject, vertical position, turning or rolling movements, sedentary state, fitness level, and cardiovascular condition of Young, which incorporates expected pressures based on the programmed pattern due to the very nature of comparison of the readings relative to a database of expected outcomes/pressures),
infer a health state of the human body in response to identifying a pattern of values in the data that indicate the criterion has been met (determine the various vital and health indicators including position, heart rate, respiration rate, sleepiness, length of sitting episodes, movement of the trunk or limbs, blood pressure, presence or lack of presence of subject, identity of subject, weight of subject, vertical position, turning or rolling movements, sedentary state, fitness level, and cardiovascular condition; the abstract, paragraphs 0001, 0003-0005, 0019, 0026-0027, 0030, 0033, 0036-0043, 0046-0051, 0057-0059, 0061, and 0063 of Young), and
cause presentation of a notification that specifies the health state (generating the audio notification of Young; paragraph 0030-0031, 0033, and 0061-0063 of Young).
With respect to claim 15, the combination teaches or suggests that each channel of the multi-channel tubing (the multi-channel tubing 135 of Squitieri) corresponds to a different one of the plurality of chambers of the pressure-mitigation device (paragraph 0082 of Squitieri).
With respect to claim 19, the combination teaches or suggests an audio output unit through which information is audibly presentable; wherein the notification is presented via the audio output unit (the alarm system that generates the audio notification of Young; paragraph 0030-0031, 0033, and 0061-0063 of Young).
Claims 1-5, 14-16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0164677 (Squitieri)(previously cited), in view of U.S. Patent Application Publication No. 2015/0008710 (Young)(previously cited), and further in view U.S. Patent Application Publication No. 2005/0022606 (Partin)(previously cited) and U.S. Patent No 11,904,103 (Franceschetti)(previously cited), and further in view of U.S. Patent Application Publication No. 2008/0000477 (Huster)(previously cited).
Squitieri teaches a method performed by a controller (the control system 130 of Squitieri) comprising: a structural body that includes a first fluid interface (the connector for the pump 132 of Squitieri; paragraphs 0080 and 0083 of Squitieri) to which a pump (the pump 132 of Squitieri) is fluidly couplable and a second fluid interface (the connector for the multi-channel tubing 135 of Squitieri; paragraphs 0080 and 0082 of Squitieri) to which a pressure-mitigation device (the pressure mitigation support device 120 of Squitieri) with a plurality of chambers (the independently pressurized relief chambers of Squitieri; paragraphs 0007, 0018-0019, 0026, 0057, 0062-0064, and 0068 of Squitieri) is fluidly couplable. The method of Squitieri comprises the steps of causing, by the controller, the plurality of chambers to be independently inflated to varying degrees in accordance with a programmed pattern (paragraphs 0080 and 0099 of Squitieri), in response to a determination that the pressure-mitigation device is disposed between the human body in a supine position and a surface (paragraphs 0099 and 0167 of Squitieri); and receiving, by the controller, data that is representative of a temporal series of measurements generated by a plurality of pressure sensors in the pressure-mitigation device (paragraphs 0060, 0099, and 0193 of Squitieri), wherein each pressure sensor of the plurality of pressure sensors is responsible for monitoring pressure of a corresponding chamber of the pressure-mitigation device in real time (paragraphs 0060, 0099, and 0193 of Squitieri), and outputting a corresponding subset of the measurements to indicate the pressure of the corresponding chamber (paragraphs 0060, 0099, and 0193 of Squitieri).
Young teaches the use of processors and memories (paragraphs 0024, 0028, and 0045 of Young) for parsing data to identify patterns of the measurements that are indicative of movements of the human body (parsing the data from the pressure sensors; abstract, paragraphs 0003-0005, 0019, 0026-0027, 0030, 0033, 0037, 0039-0041, 0049, 0057-0059, 0061, and 0063 of Young); determining various vital and health indicators including position, heart rate, respiration rate, sleepiness, length of sitting episodes, movement of the trunk or limbs, blood pressure, presence or lack of presence of subject, identity of subject, weight of subject, vertical position, turning or rolling movements, sedentary state, fitness level, and cardiovascular condition (the abstract, paragraphs 0003-0005, 0019, 0026-0027, 0030, 0033, 0037, 0039-0041, 0049, 0057-0059, 0061, and 0063 of Young); and generating an audio notification that specifies the various vital and health indicators that are a potential problem or need for a change to a display (paragraph 0030-0031, 0033, and 0061-0063 of Young). Partin further teaches the detection of body movements characteristic of convulsions or seizures by identifying readings at a particular frequency with abnormally large variations (paragraphs 0014 and 0020 and claim 23 of Partin). Partin is pertinent to the teachings of Young since Young suggests the monitoring of body movements and Partin teaches that convulsions or seizures are types of potentially serious body movements. Franceschetti teaches that such frequencies are high compared to heart rate (col. 26, lines 35-51 of Franceschetti). Further, Franceschetti teaches that alerts should be generated with occurrences of seizures (col. 26, lines 35-51 of Franceschetti). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the processors and memories for performing the steps of parsing, determining, and generating the audio notification of Young so as to identify potential problems in various vital and health indictors, including the occurrences of seizures and convulsions, and generate audio notifications of such problems, including the occurrences of seizures and convulsions, so as to address potential health problems as they occur.
The combination teaches or suggest the determination of various vital and health indictors, including the occurrences of seizures and convulsions. Young teaches that such determination can be done using pattern recognition (paragraphs 0027, 0040, and 0049 of Young). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include pattern recognition when identifying various vital and health indictors, including the occurrences of seizures and convulsions, since a mechanism for making such an identification is required and Young teaches one such identification and/or it is a simple substitution of one known element for another to obtain predictable results.
Huster teaches that the same controller housing may encompass the pumping system and the diagnostic system (FIGS. 12-13 and paragraphs 0005, 0048, 0115, 0124-0125, 0141-0142, and 0151 of Huster). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the capabilities for performing the steps of parsing, determining, and generating the audio notification of seizures and convulsions in the controller, as suggested by Huster, since it would make the system more compact.
Further, Young teaches the placement of pressure sensors inside the inflatable chambers (abstract and paragraphs 0003-0005 and 0022-0023 of Young). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the pressure sensors inside the inflatable chambers, as suggested by Young, rather than building them into the side support portions because it is a simple substitution of one known element for another to obtain predictable results.
The combination teaches the use of the pressure-mitigation device with a pressure device 132 and connectors for attachment of the multi-channel tubing 135 to the control system (paragraph 0080 of Squitieri). Huster teaches the use of Hall effect sensors at ports at the surface of the controller to detect the presence of a magnet attached to an end of a hose so as to confirm the coupling of the hose to its connector at the surface of the controller (paragraph 0151 of Huster). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Hall effect sensors at ports at the surface of the control system 130 to detect the presence of magnets attached to the multi-channel tubing 135, as suggested by Huster, since it confirms the attachment of the coupling of the multi-channel tubing 135 to the control system 130.
With respect to claim 1, the combination teaches or suggests a non-transitory medium with instructions stored thereon that, when executed by a processor, cause the processor to perform operations comprising:
initiating a connection with a controller that is responsible for controllably inflating chambers of a pressure-mitigation device that is disposed between a human body and a surface (paragraphs 0080, 0099, and 0167 of Squitieri);
obtaining, via the connection in real time, data that indicates pressure of each of the chambers over a period of time (obtaining data from the pressure sensors; paragraphs 0060, 0099, and 0193 of Squitieri);
examining the data so as to establish that at least some of the chambers experienced high-frequency changes over the period of time (parsing the data from the pressure sensors; abstract, paragraphs 0003-0005, 0019, 0026-0027, 0030, 0033, 0037, 0039-0041, 0049, 0057-0059, 0061, and 0063 of Young);
determining that the human body is experiencing a seizure based on (i) detected patterns and magnitudes of the high-frequency changes and (ii) expected pressures of the plurality of chambers from the programmed pattern (determine convulsions and seizures as suggested by Young, Partin, and Franceschetti; the use of pattern recognition when identifying various vital and health indicators including seizures and convulsions, which incorporates expected pressures based on the programmed pattern due to the very nature of comparison of the readings relative to a database of expected outcomes/pressures); and
causing presentation of a notification that specifies the human body is experiencing the seizure (generating the audio notification of convulsions and seizures as suggested by Young, Partin, and Franceschetti).
With respect to claim 2, the combination teaches or suggests that the high-frequency changes are determined to be representative of a seizure in response to a determination that the high-frequency changes match a predefined pattern (the use of pattern recognition when identifying various vital and health indicators including seizures and convulsions).
With respect to claim 3, the combination teaches or suggests that the predefined pattern is one of multiple predefined patterns against which the high-frequency changes are compared (the use of pattern recognition when identifying various vital and health indicators including seizures and convulsions).
With respect to claim 4, the combination teaches or suggests that each of the multiple predefined patterns is associated with a different type of medical event (the use of pattern recognition when identifying various vital and health indicators including seizures and convulsions).
With respect to claim 5, the combination teaches or suggests that said determining includes applying, to the data, a model that is trained to detect patterns of the high-frequency changes that are representative of seizures (the use of pattern recognition when identifying various vital and health indicators including seizures and convulsions).
With respect to claim 14, the combination teaches or suggests a controller for managing fluid flow into a pressure-mitigation device (the pressure mitigation support device 120 of Squitieri) that has a plurality of chambers (the independently pressurized relief chambers of Squitieri; paragraphs 0007, 0018-0019, 0026, 0057, 0062-0064, and 0068 of Squitieri) intertwined in a geometric shape, the controller comprising:
a structural body (the housing of the modified control system 130 of Squitieri) that includes a fluid interface (the connector for the pump 132 of Squitieri; paragraphs 0080 and 0083 of Squitieri) to which the pressure-mitigation device is fluidly couplable via multi-channel tubing (the multi-channel tubing 135 of Squitieri);
a processor (the processors of Squitieri/Young; see paragraphs 0083, 0139, and 0141 of Squitieri); and
a memory (the memories of Squitieri/Young; see paragraphs 0083, 0139, and 0141 of Squitieri) that includes instructions that, when executed by the processor, cause the controller to:
cause the plurality of chambers to be independently inflated to varying degrees in accordance with a programmed pattern (paragraphs 0080 and 0099 of Squitieri), in response to a determination that the pressure-mitigation device is disposed between a human body in a supine position and a surface (paragraphs 0099 and 0167 of Squitieri);
obtain data that is indicative of pressure of each of the plurality of chambers over time (obtaining data from the pressure sensors; paragraphs 0060, 0099, and 0193 of Squitieri), wherein each of the plurality of pressure sensors is associated with a corresponding one of the plurality of chambers and a corresponding subset of the measurements (paragraphs 0060, 0099, and 0193 of Squitieri; abstract and paragraphs 0003-0005 and 0022-0023 of Young),
examine the data in comparison to expected pressures of the plurality of chambers based the programmed pattern, so as to establish whether a criterion has been met relating to movement of the human body (parsing the data from the pressure sensors; abstract, paragraphs 0003-0005, 0019, 0026-0027, 0030, 0033, 0037, 0039-0041, 0049, 0057-0059, 0061, and 0063 of Young; the use of pattern recognition when identifying various vital and health indicators, which incorporates expected pressures based on the programmed pattern due to the very nature of comparison of the readings relative to a database of expected outcomes/pressures),
infer a health state of the human body in response to identifying a pattern of values in the data that indicate the criterion has been met (determine convulsions and seizures as suggested by Young, Partin, and Franceschetti), and
cause presentation of a notification that specifies the health state (generating the audio notification of convulsions and seizures as suggested by Young, Partin, and Franceschetti).
With respect to claim 15, the combination teaches or suggests that each channel of the multi-channel tubing (the multi-channel tubing 135 of Squitieri) corresponds to a different one of the plurality of chambers of the pressure-mitigation device (paragraph 0082 of Squitieri).
With respect to claim 16, the combination teaches or suggests that to examine the data, the controller determines, based on an analysis of the data, whether the human body is experiencing a seizure (determine convulsions and seizures as suggested by Young, Partin, and Franceschetti).
With respect to claim 19, the combination teaches or suggests an audio output unit through which information is audibly presentable; wherein the notification is presented via the audio output unit (the alarm system that generates the audio notification of Young; paragraph 0030-0031, 0033, and 0061-0063 of Young).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0164677 (Squitieri)(previously cited), in view of U.S. Patent Application Publication No. 2015/0008710 (Young)(previously cited), and further in view U.S. Patent Application Publication No. 2005/0022606 (Partin)(previously cited) and U.S. Patent No 11,904,103 (Franceschetti)(previously cited), and further in view of U.S. Patent Application Publication No. 2008/0000477 (Huster)(previously cited), and further in view of U.S. Patent Application Publication No. 2018/0088669 (Ramaprakash)(previously cited).
Ramaprakash teaches that readings indicating a seizure should last three seconds (paragraph 0048 of Ramaprakash)1 before indicating a seizure. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the processors and memories for performing the steps of parsing, determining, and generating the audio notification of Young so as to identify occurrences of seizures and convulsions that last for three seconds so as to avoid false alarms.
With respect to claim 6, the combination teaches or suggest that said determining-includes establishing that the high-frequency changes exceed a predetermined magnitude and occur over an interval of time no longer than ten seconds (determining convulsions or seizures that last for three seconds; abstract, paragraphs 0003-0005, 0019, 0026-0027, 0030, 0033, 0037, 0039-0041, 0049, 0057-0059, 0061, and 0063 of Young; paragraph 0048 of Ramaprakash).
Claims 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0164677 (Squitieri)(previously cited), in view of U.S. Patent Application Publication No. 2015/0008710 (Young)(previously cited), and further in view U.S. Patent Application Publication No. 2005/0022606 (Partin)(previously cited), U.S. Patent No 11,904,103 (Franceschetti)(previously cited), and U.S. Patent Application Publication No. 2018/0088669 (Ramaprakash)(previously cited) further in view of U.S. Patent Application Publication No. 2008/0000477 (Huster)(previously cited).
Squitieri teaches a method performed by a controller (the control system 130 of Squitieri) comprising: a structural body that includes a first fluid interface (the connector for the pump 132 of Squitieri; paragraphs 0080 and 0083 of Squitieri) to which a pump (the pump 132 of Squitieri) is fluidly couplable, and a second fluid interface (the connector for the multi-channel tubing 135 of Squitieri; paragraphs 0080 and 0082 of Squitieri) to which a pressure-mitigation device (the pressure mitigation support device 120 of Squitieri) with a plurality of chambers (the independently pressurized relief chambers of Squitieri; paragraphs 0007, 0018-0019, 0026, 0057, 0062-0064, and 0068 of Squitieri) is fluidly couplable. The method of Squitieri comprises the steps of causing, by the controller, the plurality of chambers to be independently inflated to varying degrees in accordance with a programmed pattern (paragraphs 0080 and 0099 of Squitieri), in response to a determination that the pressure-mitigation device is disposed between the human body in a supine position and a surface (paragraphs 0099 and 0167 of Squitieri); and receiving, by the controller, data that is representative of a temporal series of measurements generated by a plurality of pressure sensors in the pressure-mitigation device (paragraphs 0060, 0099, and 0193 of Squitieri), wherein each pressure sensor of the plurality of pressure sensors is responsible for monitoring pressure of a corresponding chamber of the pressure-mitigation device in real time (paragraphs 0060, 0099, and 0193 of Squitieri), and outputting a corresponding subset of the measurements to indicate the pressure of the corresponding chamber (paragraphs 0060, 0099, and 0193 of Squitieri).
Young teaches the use of processors and memories (paragraphs 0024, 0028, and 0045 of Young) for parsing data to identify patterns of the measurements that are indicative of movements of the human body (parsing the data from the pressure sensors; abstract, paragraphs 0003-0005, 0019, 0026-0027, 0030, 0033, 0037, 0039-0041, 0049, 0057-0059, 0061, and 0063 of Young); determining various vital and health indicators including position, heart rate, respiration rate, sleepiness, length of sitting episodes, movement of the trunk or limbs, blood pressure, presence or lack of presence of subject, identity of subject, weight of subject, vertical position, turning or rolling movements, sedentary state, fitness level, and cardiovascular condition (the abstract, paragraphs 0003-0005, 0019, 0026-0027, 0030, 0033, 0037, 0039-0041, 0049, 0057-0059, 0061, and 0063 of Young); and generating an audio notification that specifies the various vital and health indicators that are a potential problem or need for a change to a display (paragraph 0030-0031, 0033, and 0061-0063 of Young). Partin further teaches that detection of body movements characteristic of convulsions or seizures by identifying readings at a particular frequency with abnormally large variations (paragraphs 0014 and 0020 and claim 23 of Partin). Partin is pertinent to the teachings of Young since Young suggests the monitoring of body movements and Partin teaches that convulsions or seizures are types of potentially serious body movements. Franceschetti teaches that such frequencies are high compared to heart rate (col. 26, lines 35-51 of Franceschetti). Further, Franceschetti teaches that alerts should be generated with occurrences of seizures (col. 26, lines 35-51 of Franceschetti). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the processors and memories for performing the steps of parsing, determining, and generating the audio notification of Young so as to identify potential problems in various vital and health indictors, including the occurrences of seizures and convulsions, and generate audio notifications of such problems, including the occurrences of seizures and convulsions, so as to address potential health problems as they occur.
The combination teaches or suggest the determination of various vital and health indictors, including the occurrences of seizures and convulsions. Young teaches that such determination can be done using pattern recognition (paragraphs 0027, 0040, and 0049 of Young). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include pattern recognition when identifying various vital and health indictors, including the occurrences of seizures and convulsions, since a mechanism for making such an identification is required and Young teaches one such identification and/or it is a simple substitution of one known element for another to obtain predictable results.
Ramaprakash teaches that readings indicating a seizure should last three seconds (paragraph 0048 of Ramaprakash)2 before indicating a seizure. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the processors and memories for performing the steps of parsing, determining, and generating the audio notification of Young so as to identify occurrences of seizures and convulsions that last for three seconds so as to avoid false alarms.
Huster teaches that the same controller housing may encompass the pumping system and the diagnostic system (FIGS. 12-13 and paragraphs 0005, 0048, 0115, 0124-0125, 0141-0142, and 0151 of Huster). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the capabilities for performing the steps of parsing, determining, and generating the audio notification of seizures and convulsions in the controller, as suggested by Huster, since it would make the system more compact.
Further, Young teaches the placement of pressure sensors inside the inflatable chambers (abstract and paragraphs 0003-0005 and 0022-0023 of Young). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the pressure sensors inside the inflatable chambers, as suggested by Young, rather than building them into the side support portions because it is a simple substitution of one known element for another to obtain predictable results.
The combination teaches the use of the pressure-mitigation device with a pressure device 132 and connectors for attachment of the multi-channel tubing 135 to the control system (paragraph 0080 of Squitieri). Huster teaches the use of Hall effect sensors at ports at the surface of the controller to detect the presence of a magnet attached to an end of a hose so as to confirm the coupling of the hose to its connector at the surface of the controller (paragraph 0151 of Huster). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Hall effect sensors at ports at the surface of the control system 130 to detect the presence of magnets attached to the multi-channel tubing 135, as suggested by Huster, since it confirms the attachment of the coupling of the multi-channel tubing 135 to the control system 130.
With respect to claim 7, the combination teaches or suggests a method performed by a controller (the control system 130 of Squitieri) that has a durable housing (the controller housing of the modified control system 130 pf Squitieri) in which a processor (the processors of Squitieri/Young) resides, the method comprising:
receiving input indicating that a pressure-mitigation device (the pressure mitigation support device 120 of Squitieri) is fluidically coupled to a fluid interface that is accessible along a surface of the durable housing (the confirmation of coupling of the tubing 135 to the control system 130 use to the Hall effect sensors at ports at the surface of the control system 130 to detect the presence of magnets attached to the multi-channel tubing 135), wherein the pressure-mitigation device includes a plurality of chambers (the independently pressurized relief chambers of Squitieri; paragraphs 0007, 0010, 0018-0019, 0024, 0026, and 0068 of Squitieri) that are intertwined to collectively have a geometric form;
causing the plurality of chambers to be inflated to varying degrees in accordance with a programmed pattern (paragraphs 0080 and 0099 of Squitieri), so as to shift force that is applied to a human body by an underlying surface;
obtaining data that is indicative of pressure of each of the plurality of chambers over time (paragraphs 0060, 0099, and 0193 of Squitieri; abstract and paragraphs 0003-0005 and 0022-0023 of Young);
examining the data so as to establish that at least some of the chambers experienced high-frequency changes over an interval of time not exceeding a predetermined length (parsing the data from the pressure sensors for readings that indicate convulsions or seizures that last for three seconds; abstract, paragraphs 0003-0005, 0019, 0026-0027, 0030, 0033, 0037, 0039-0041, 0049, 0057-0059, 0061, and 0063 of Young; paragraph 0048 of Ramaprakash);
determining that the human body is experiencing a seizure based on (i) patterns and magnitudes of the high-frequency changes and (ii) expected pressures of the plurality of chambers from the programmed pattern (determine convulsions and seizures as suggested by Young, Partin, and Franceschetti; the use of pattern recognition when identifying various vital and health indicators incorporates expected pressures based on the programmed pattern due to the very nature of comparison of the readings relative to a database of expected outcomes/pressures); and
causing presentation of a notification that specifies the human body is experiencing the seizure (generating the audio notification of convulsions and seizures as suggested by Young, Partin, and Franceschetti).
With respect to claim 8, the combination teaches or suggests that the predetermined length is no longer than 5 seconds (parsing the data from the pressure sensors for readings that indicate convulsions or seizures that last for three seconds; abstract, paragraphs 0003-0005, 0019, 0026-0027, 0030, 0033, 0037, 0039-0041, 0049, 0057-0059, 0061, and 0063 of Young; paragraph 0048 of Ramaprakash).
With respect to claim 9, the combination teaches or suggests that the predetermined length is no longer than 3 seconds (parsing the data from the pressure sensors for readings that indicate convulsions or seizures that last for three seconds; abstract, paragraphs 0003-0005, 0019, 0026-0027, 0030, 0033, 0037, 0039-0041, 0049, 0057-0059, 0061, and 0063 of Young; paragraph 0048 of Ramaprakash).
With respect to claim 10, the combination teaches or suggests that determining includes applying, to the data, a model that is trained to detect patterns and magnitudes of high-frequency changes that are representative of seizures (the use of pattern recognition when identifying various vital and health indicators including seizures and convulsions).
With respect to claim 11, the combination teaches or suggests that said causing the plurality of chambers to be inflated is performed in response to a determination that the pressure- mitigation device is disposed between the human body and the underlying surface (paragraphs 0099 and 0167 of Squitieri).
With respect to claim 12, the combination teaches or suggests that the determination is based on input provided by an operator through an interaction with the controller (Squitieri teaches that the control system 130 is configured to be programmed by a patient, healthcare personnel, the patient, etc. For example, the control system 130 can be programmed on a patient-specific basis to manage and mitigate pressure on one or more existing pressure ulcers that are currently present on a patient in a specific anatomic location (paragraphs 0081, 0083, 0088, 0098, 0108, 0125, and 0149 of Squitieri) such programming affects the determination that the pressure-mitigation device is disposed between the human body and the underlying surface (paragraphs 0099 and 0167 of Squitieri)).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable U.S. Patent Application Publication No. 2015/0164677 (Squitieri)(previously cited), in view of U.S. Patent Application Publication No. 2015/0008710 (Young)(previously cited), and further in view U.S. Patent Application Publication No. 2005/0022606 (Partin)(previously cited), U.S. Patent No 11,904,103 (Franceschetti)(previously cited), and U.S. Patent Application Publication No. 2018/0088669 (Ramaprakash)(previously cited) further in view of U.S. Patent Application Publication No. 2008/0000477 (Huster)(previously cited), and further in view of U.S. Patent Application Publication No. 2010/0174198 (Young 198)(previously cited).
The combination teaches or suggests that the instructions further cause the controller to: cause presentation of a notification that specifies the health state (generating the audio notification of convulsions and seizures as suggested by Young, Partin, and Franceschetti).
Young 198 that such status information may be sent to a database or other source via a wireless transmitter to be analyzed at a later time to determine long-term trends (paragraph 0030 of Young 198). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to send the notification of Young so as to identify and display recorded and determined data to a database or other source via a wireless transmitter since such data can be analyzed at a later time to determine long-term trends.
With respect to claim 13, the combination teaches or suggest transmitting at least some of the data to a destination external to the controller for further analysis(the wireless transmission suggested by Young 198).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Squitieri, in view of Young, and further in view of Huster, and further in view of U.S. Patent Application Publication No. 2010/0174198 (Young 198)(previously cited).
The combination teaches or suggests that the instructions further cause the controller to: cause presentation of a notification that specifies the health state (generating the audio notification of Young; paragraph 0030-0031, 0033, and 0061-0063 of Young).
Young 198 that such status information may be sent to a database or other source via a wireless transmitter to be analyzed at a later time to determine long-term trends (paragraph 0030 of Young 198). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to send the notification of Young so as to identify and display the recorded and determined data to a database or other source via a wireless transmitter since such data can be analyzed at a later time to determine long-term trends.
With respect to claim 20, the combination teaches or suggest a communication module (the wireless transmitter of Young 198) that is configured to establish a wireless communication channel with a destination external to the controller; wherein said causing presentation of the notification includes transmitting, via the communication module, the notification to the destination for presentation (the wireless transmission suggested by Young 198).
Response to Arguments
The Applicant's arguments filed on 6/23/2026 have been fully considered.
Claim objections
There are new claim objections that were necessitated by the claim amendments filed on 6/23/2026.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
There are new claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that were necessitated by the claim amendments filed on 6/23/2026.
Also, the Applicant did not address, by amendment or argument, the indefiniteness issues with respect to “high-frequency changes” in claim 10, lines 2-3 and “seizures” in claim 10, line 3. The Examiner cannot find a reason to withdraw the rejection.
Prior art rejection
The Applicant asserts:
PNG
media_image1.png
315
1009
media_image1.png
Greyscale
Upon full consideration of the prior art, these arguments are not persuasive. In particular, the combination teaches or suggest the determination of various vital and health indictors, including the occurrences of seizures and convulsions. Young teaches that such determination can be done using pattern recognition (paragraphs 0027, 0040, and 0049 of Young). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include pattern recognition when identifying various vital and health indictors, including the occurrences of seizures and convulsions, since a mechanism for making such an identification is required and Young teaches one such identification and/or it is a simple substitution of one known element for another to obtain predictable results.
As a result, the combination teaches or suggests determining that the human body is experiencing a seizure based on (i) detected patterns and magnitudes of the high-frequency changes and (ii) expected pressures of the plurality of chambers from the programmed pattern by determining convulsions and seizures as suggested by Young, Partin, and Franceschetti through the use of pattern recognition. The pattern recognition algorithm incorporates expected pressures based on the programmed pattern due to the very nature of comparison of the readings relative to a database of expected outcomes/pressures. Also, the use of pattern recognition does detect patterns of frequency and magnitude when comparing the readings to the database of expected outcomes/pressures.
Conclusion
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 MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 U.S. Patent Application Publication No. 2004/0133390 (Osorio) also teaches that a span of 0.5 seconds can be used to establish a span of meaningful data for determining seizures (paragraphs 0160-0162 and meaningful data 2323 in FIG. 23 of Osorio).
2 U.S. Patent Application Publication No. 2004/0133390 (Osorio) also teaches that a span of 0.5 seconds can be used to establish a span of meaningful data for determining seizures (paragraphs 0160-0162 and meaningful data 2323 in FIG. 23 of Osorio).
Prosecution Insights