DETAILED ACTION
Applicant’s arguments, filed 06/26/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicant has amended their claims, filed 06/26/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant canceled claims 7, 9, and 13. Claims 1-6, 8, 10-12, and 14-16 are pending and hereby under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6, 8, 10-12, and 14-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claims 1 and 10:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a system, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claim 10 is directed to a computer implemented method, which describes one of the four statutory categories of patentable subject matter, i.e., a method. Therefore, further consideration is necessary regarding the claims.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1 and 10 recite an abstract idea. In particular, the claims generally recite
the following:
determine a default craniocaudal rotation axis plane;
determine, based on a plurality of three-axis acceleration signals of the three-axis accelerometer over time and the default craniocaudal rotation axis plane, a reference craniocaudal rotation axis, by, from a plurality of three-axis acceleration measurements corresponding to gravity vectors, deriving a respective cross product vector for a plurality of pairs of the gravity vectors, inverting selected cross product vectors such that all resulting cross product vectors are directed within a common semi- sphere, and obtaining the reference craniocaudal rotation axis as a unity vector having a direction based on an average of the resulting cross product vectors;
calibrate a default orientation about the reference craniocaudal rotation axis within the default craniocaudal rotation axis plane by at least one of: obtaining a calibration measurement during which the subject tans the accelerometer; and analyzing a spread of rotation angles over time;
determine for a first three-axis acceleration signal a rotation angle about the reference craniocaudal rotation axis relative to the calibrated default orientation;
determine the sleep posture of the subject based on the determined rotation angle;
compare the determined sleep posture to a first therapeutic sleep posture threshold.
These elements recited in claims 1 and 10 are drawn to an abstract idea since they are directed to mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III) and mathematical concepts –mathematical relationships, mathematical formulas or equations, mathematical calculations (see MPEP § 2106.04(a)(2), subsection I).
“determine a default craniocaudal rotation axis plane” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably define an axis/plane as a default to use as a reference to other measurements. There is nothing to suggest an undue level of complexity in “determine a default craniocaudal rotation axis plane”.
“determine, based on a plurality of three-axis acceleration signals of the three-axis accelerometer over time and the default craniocaudal rotation axis plane, a reference craniocaudal rotation axis, by, from a plurality of three-axis acceleration measurements corresponding to gravity vectors, deriving a respective cross product vector for a plurality of pairs of the gravity vectors, inverting selected cross product vectors such that all resulting cross product vectors are directed within a common semi-sphere, and obtaining the reference craniocaudal rotation axis as a unity vector having a direction based on an average of the resulting cross product vectors” is drawn to a mathematical concept. Deriving a cross product from gravity vectors and inverting the cross product is a mathematical concept to calculate the direction and magnitude of a resulting vector.
“calibrate a default orientation about the reference craniocaudal rotation axis within the default craniocaudal rotation axis plane by at least one of: obtaining a calibration measurement during which the subject tans the accelerometer; and analyzing a spread of rotation angles over time” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably define a default orientation about a rotation axis by analyzing rotation angles from accelerometer data. There is nothing to suggest an undue level of complexity in “calibrate a default orientation about the reference craniocaudal rotation axis within the default craniocaudal rotation axis plane by at least one of: obtaining a calibration measurement during which the subject tans the accelerometer; and analyzing a spread of rotation angles over time”.
“determine for a first three-axis acceleration signal a rotation angle about the reference craniocaudal rotation axis relative to the calibrated default orientation” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably determine a rotation angle about a reference axis from accelerometer data relative to the calibrated default orientation. There is nothing to suggest an undue level of complexity in “determine for a first three-axis acceleration signal a rotation angle about the reference craniocaudal rotation axis relative to the calibrated default orientation”.
“determine the sleep posture of the subject based on the determined rotation angle” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably determine a sleep posture of a subject based on the determined rotation angle with respect to a reference axis. There is nothing to suggest an undue level of complexity in “determine the sleep posture of the subject based on the determined rotation angle”.
“compare the determined sleep posture to a first therapeutic sleep posture threshold” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably compare a posture to set posture threshold. There is nothing to suggest an undue level of complexity in “compare the determined sleep posture to a first therapeutic sleep posture threshold”.
Prong Two: Claims 1 and 10 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are "directed to" the abstract idea. The additional elements merely:
Recite the words "apply it" or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “a controller” (claim 1)) and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data gathering components (e.g., "a three-axis accelerometer" (claim 1) and "receiving three-axis accelerometer signals from an accelerometer" (claim 10)); the post-solution activity of: (e.g. “a user interface” (claim 1), “causing a user interface to provide vibratory feedback to the subject to initiate a sleep posture change” (claims 1 and 10), “track transitions between sleep postures over time based on the determined rotation angles and to control actuation of the user interface in dependence on the determined sleep posture” (claims 1 and 10)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 10 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to implementing the abstract ideas on generic processing components, the pre-solution activity of using generic data-gathering components, and generic post-solution activities, which merely facilitate the abstract idea.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “a controller” as disclosed in the Applicant’s specification on page 12, lines 20-31, “The controller can be implemented in numerous ways, with software and/or hardware, to perform the various functions required. A processor is one example of a controller which employs one or more microprocessors that may be programmed using software (e.g., microcode) to perform the required functions. A controller may however be implemented with or without employing a processor, and also may be implemented as a combination of dedicated hardware to perform some functions and a processor (e.g., one or more programmed microprocessors and associated circuitry) to perform other functions. Examples of controller components that may be employed in various embodiments of the present disclosure include, but are not limited to, conventional microprocessors, application specific integrated circuits (ASICs), and field-programmable gate arrays (FPGAs)”.
Further, "a user interface" and “a three-axis accelerometer” do not qualify as significantly more because these limitations are simply appending well understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well understood, routine and conventional activity previously known in the industry (see Electric PowerGroup, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014); SAP Am. v. lnvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of dependent claims 2-6, 8, 11-12, and 14-16:
Claims 4-5 and 13 recite mental steps that may be performed in the human mind with the aid of pen and paper or a generic computer, which add to the abstract idea. The mental steps are identified as:
“wherein the controller is adapted to determine the head-to-toe direction of the reference craniocaudal axis relative to the subject” (claim 4);
“wherein the controller is adapted to determine the head-to-toe direction of the reference craniocaudal axis relative to the subject by: monitoring accelerations during sitting or standing; or monitoring accelerations caused by vital signs” (claim 5); and
“comprising determining the head-to-toe direction of the reference craniocaudal axis relative to the subject by: monitoring accelerations during sitting or standing; or monitoring accelerations caused by vital signs” (claim 13).
Claims 2-3 and 11 recite steps that are mathematical concepts, which add to the abstract idea. The mathematical concepts are identified as:
“deriving a respective cross product vector for a plurality of pairs of the three-axis acceleration measurements; and inverting selected cross product vectors such that all resulting cross product vectors are directed within a common semi-sphere; and obtaining the reference craniocaudal rotation axis from the resulting cross product vectors” (claim 2);
“wherein the controller is adapted to determine the reference craniocaudal rotation axis as a unity vector having a direction based on an average of the resulting cross product vectors” (claim 3); and
“determining the reference craniocaudal rotation axis by: deriving a respective cross product vector for a plurality of pairs of the three- axis acceleration measurements; inverting selected cross product vectors such that all resulting cross product vectors are directed within a common semi-sphere; and obtaining the reference craniocaudal rotation axis from the resulting cross product vectors” (claim 11).
Claims 6, 8, 12, and 15-16 recite limitation in addition to the abstract idea: they merely
Further describe the abstract idea (“wherein vital signs comprise breathing or heart beats” (claim 6), “wherein the controller is further adapted to calibrate the default orientation about the reference craniocaudal rotation axis plane by obtaining a calibration measurement during which the subject is supine” (claims 8 and 12), “a non-transitory computer readable medium having a computer program code stored thereon, that when said computer program code is executed on a computer, implements the method of claim 10” (claim 15), and “wherein the default craniocaudal rotation axis plane is horizontal” (claim 16)).
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. The result of the abstract idea does not cause the computing device and/or application to perform differently.
Therefore, claims 1-6, 8, 10-12, and 14-16 are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 8, 10-12, and 14-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed towards a user interface configured to provide vibratory feedback. The specification only recites that vibratory feedback in the background section regarding well known electronic positional sleep therapy devices where the vibratory feedback is provided to the subject to prompt the subject to change his or her position once (see Page 1, lines 28-31). This recitation is only described with respect to prior art, rather than the instant invention. The rest of the specification is devoid of any step of providing vibratory feedback or any structure capable of providing such feedback. The specification further recites that an alert system alerts the subject of the need to change their sleep posture in dependence on the determined sleep posture (see page 4, lines 34-35 and page 12, lines 18-19). There is no connection between the alert system and the step of providing vibratory feedback or the user interface. Therefore, the claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time of filing.
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 1-6, 8, 10-12, and 14-16 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.
Regarding claims 1, 8, 10, and 14, it is unclear what the step of “calibrate/calibrating a default orientation” is “calibrating”. There is no original “default orientation” that is measured, obtained, or assumed. Thus, it is unclear what is included in the “calibration” step. Is there an original default orientation that is updated regularly? How is the default orientation separate or distinct from the reference craniocaudal rotation axis / default craniocaudal rotation axis plane? It appears the calibration is merely defining an orientation by either obtaining a “calibration measurement” or analyzing rotation angles over time. However, it is unclear as to what a “calibration measurement” requires since there is no initial measurement taken to compare or calibrate to. For examination purposes, only one of these two steps will be required to meet the claim. “Calibration measurement” is interpreted to mean any step for defining an orientation. Claims 2-6, 11-12, and 15-16 are also rejected due to their dependence on these claims.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-3 and 11 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 1 and 10 require “deriving a respective cross product vector for a plurality of pairs of gravity vectors” from a plurality of three-axis acceleration measurements, “inverting selected cross product vectors such that all resulting cross product vectors are directed within a common semi-sphere”, and “obtaining the reference craniocaudal rotation axis as a unity vector having a direction based on an average of the resulting cross product vectors”. The limitations recited in claims 2-3 and 11 are already required in claims 1 and 10, the claims from which claims 2-3 and 11 depend. Therefore, the claims fail to further limit the subject matter of the claim upon which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 8, 10-12, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Dieken (US 20190160282 – cited by Applicant) in view of Panken (US 20100010583).
Regarding claims 1-3, Dieken discloses a system for determining a sleep posture of a subject, comprising:
a user interface configured to provide vibratory feedback to the subject (Fig. 16, notification function 1440 with haptic 1444);
a three-axis accelerometer for coupling to the subject (Fig. 1A, accelerometer based sensor 70; Paragraph 0071, “in some examples the accelerometer sensor 360 comprises a multi-axis accelerometer such as a three-axis accelerometer”); and
a controller (Fig. 12A, controller 1002; Paragraph 0143, “In some examples, control portion 1000 provides one example implementation of a control portion forming a part of, implementing, and/or managing any one of devices, systems, assemblies, circuitry, managers, engines, functions, parameters, sensors, electrodes, and/or methods, as represented throughout the present disclosure in association with FIGS. 1-11B and 13-19”), wherein the controller is adapted to:
determine a default craniocaudal rotation axis plane (Paragraph 0063-0065, wherein the accelerometer is arranged such that it maintains a proper orientation relative to the patient’s body);
determine, based on a plurality of three-axis acceleration signals of the three-axis accelerometer over time and the default craniocaudal rotation axis plane, a reference craniocaudal rotation axis (Paragraph 0110 and 0114, wherein, in an alternate embodiment, the posture function determines whether the patient is lying down, standing up, or generally vertical based on the measured angles of the accelerometer; Paragraph 0194, wherein the system continuously tracks sleeping posture data); and
calibrate a default orientation about the reference craniocaudal rotation axis within the default craniocaudal rotation axis plane by analyzing a spread of rotation angles over time (Paragraph 0114-0118, wherein the posture function 840/900 determines the sub-postures of the patient with reference to the accelerometer measurements. Examiner notes that these measurements would necessarily be based off of the proper arrangement/orientation of the accelerometers as described above and the initial posture determination; thus, they are based off of the “default craniocaudal rotation axis plane” and the “reference craniocaudal rotation axis”. In light of the 112(b) rejection and claim interpretation above, Dieken discloses measuring and defining a specific orientation of the user in the plane/rotation axis as previously described; thus, Dieken reads on the claim);
determine for a first three-axis acceleration signal a rotation angle about the reference craniocaudal rotation axis (Paragraph 0118, “Accordingly, the protocol performs a further classification via the pitch angle such that the patient is lying on their right side if the pitch angle is less than or equal to negative 45 degrees or greater than or equal to negative 135 degrees. However, the protocol determines that the patient is lying on their left side if the pitch angle is greater than or equal to 45 degrees or the pitch angle is less than or equal to 135 degrees. In some examples, a similar determination may be made using directional cosines”; Examiner notes that the default orientation has not been changed by the calibration step. As such, the rotation angle about the reference craniocaudal axis would necessarily be relative to the default orientation),
determine the sleep posture of the subject based on the determined rotation angle (Paragraph 0114, “In the example, when such an angle is less than 40°, the measurement suggests the patient is in a generally vertical position, and therefore likely not asleep”; Paragraphs 0114-0118, wherein an angle of the accelerometer determines the posture of the subject); and
compare the determined sleep posture to a first therapeutic sleep posture threshold, and responsive to the determined sleep posture being equal to the first therapeutic sleep posture threshold (Paragraph 0113, wherein the accelerometer measurement exceeds a gravity threshold; Paragraphs 0197-0198, wherein the system notifies the user to change sleep position to a position “more amenable” to respiration and the use of therapy device. Thus, the threshold is implied to be a position not amenable to respiration or with use of a therapy device), actuate the user interface so as to cause the vibratory feedback to be provided to the subject to initiate a sleep posture change (Paragraph 0197, “sleep position (obtained via a sensed posture information) may be communicated via a notification function 1440 to the patient during a sleep period in order to induce the patient to change their sleep position into one more conducive to efficacious therapy. In some examples, the communication via notification function 1440 may occur by an audible notification 1442 or haptic notification 1444 (e.g. vibratory, motion, etc.) implemented via wireless communication to a patient remote (e.g. 1030 in FIG. 12B), a user interface (e.g. 1034 in FIG. 12C), a patient support (e.g. 794 in FIG. 9C). In some examples, the haptic notification 1444 may be communicated via direct muscle stimulation via wireless communication to a wearable muscle stimulation device”), and wherein the controller is further adapted to track transitions between sleep postures over time based on the determined rotation angles (Paragraph 0194, “In some examples, posture information engine 1400 comprises a position tracking function 1420 to track physiologic information in association with at least some respective different postures. In some examples, the physiologic information comprises an amount of time spent sleeping in each posture. In some instances, such tracked physiologic information may include a number of switches between different postures”) and to control actuation of the user interface in dependence on the determined sleep posture (Paragraph 0197).
Dieken fails to disclose taking a cross product vector of the acceleration measurement, inverting the vector, obtaining the reference craniocaudal rotation axis therefrom, and determining a reference craniocaudal rotation axis as a unity vector based on an average of the cross product vectors relative to the default orientation.
Dieken and Panken are analogous art as they are in the same field of posture determination. Panken teaches a posture sensing device and method of determining the orientation of a sensor (Abstract), wherein, by taking the cross-products of pairs of accelerometer measurements and normalizing the cross-products, determine a rotation axis (Paragraph 0017, “consider multiple postures that a patient may occupy while in the prone position. Such postures may include the Face Up, Face Down, Right Side, and Left Side postures. Each such posture may be associated with a defined posture vector that is obtained from a sensor as the patient assumes the posture (e.g., Face Up). The defined posture vectors may be grouped in adjacent pairs, where adjacency refers to how the vectors are positioned in space… Four adjacent pairs may be formed using the four postures of this example. A cross-product may be formed for each adjacent pair, resulting in a vector that is perpendicular to both of the defined posture vectors in the adjacent pair. Assuming all such cross-products are generated with the right-hand rule in mind so that the resulting vectors all have a same sign (positive or negative), these cross-products will all be in a same general direction. An average of these cross-products may be derived for use as a virtual posture vector in detecting a Lying Down posture”). Panken further teaches that an average of the cross-products are derived for use as a virtual posture vector (Paragraph 0017) and the posture vectors may be normalized with respect to one another to a same, known length Paragraph 0015). Per the 112(d) rejection above, the limitations of claims 2-3 are already required in claim 1; therefore, Dieken in view of Panken read on claims 2-3.
Dieken is concerned with determining postures of a patient to determine if they are asleep and what the sleep posture is. Panken is concerned with techniques of posture classification and discusses that this method allows for more accurate posture classification (Paragraph 0018). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Dieken to incorporate the method of determining a reference rotation axis taught by Panken to more accurately calculate/describe the posture of the user.
Regarding claim 4, Dieken as modified by Panken disclose the system of claim 1 above. Dieken further discloses wherein the controller is adapted to determine the head-to-toe direction of the reference craniocaudal axis relative to the subject (Paragraph 0078, “the IPG assembly 602 is implanted to cause a longitudinal axis (line L) of its housing 104 to be generally parallel to a left to right orientation of the patient's body and generally parallel to a head to toe orientation of the patient's body”).
Regarding claim 5, Dieken as modified by Panken disclose the system of claim 4 above. Dieken further discloses wherein the controller is adapted to determine the head-to-toe direction of the reference craniocaudal axis relative to the subject by:
monitoring accelerations during sitting or standing (Paragraph 0193, “ As previously noted, in at least some instances, the posture may sometimes be referred to as body position. As shown in FIG. 16, in some examples posture information engine 1400 comprises a calibration function 1410 to compensate for an unknown orientation of the accelerometer as mounted within the patient's body. In some examples, an automatic parameter 1412 performs such calibration automatically, such as when the patient is walking because such behavior is consistent with a gravity vector pointing downward”).
Regarding claims 6, Dieken as modified by Panken disclose the system of claim 5 above. Dieken further discloses that the orientation of the accelerometer can be calibrated automatically using gravitational vectors (Paragraph 0193) and that the posture can indicate inversion of the respiration signal (Paragraph 0107, “the accelerometer utilization manager 800 comprises an inversion detection engine 830. In some instances, a sensed respiratory signal may be inverted due to posture changes, which may occur depending on the axis orientation of the accelerometer sensor relative to a surface the patient is resting on”).
Dieken further discloses monitoring accelerations caused by vital signs, wherein vital signs comprise breathing or heart beats (Paragraph 0187, “the detection engine 1310 may detect apnea-hypopnea events based on information sensed via at least an accelerometer-based sensor (FIGS. 1-9E) in accordance with at least some examples of the present disclosure. For instance, in some examples an apnea-hypopnea event management engine 1300 may track a number of apnea-hypopnea events based on at least one of changes in respiratory amplitude, changes in respiratory rate, and/or changes in heart rate”), wherein the respiration signal corresponds to a z-axis of the accelerometer (Paragraph 0101). Dieken does not explicitly disclose using the respiration signal to determine a head-to-toe direction of the reference craniocaudal axis relative to the subject.
A person of ordinary skill would be motivated to use the known relationship between the respiration signal and accelerometer orientation to determine a reference rotation axis to ensure tracking of patient respiration and orientation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Dieken to use the accelerometer-derived respiration signal to determine a reference rotation axis as disclosed by another embodiment of Dieken, as the result of determining a z-axis to calculate a reference axis would be predictable to one of ordinary skill in the art.
Regarding claim 8, Dieken as modified by Panken disclose the system of claim 1 above. Dieken further discloses that the controller is adapted to calibrate the default orientation about the reference craniocaudal rotation axis plane by obtaining a calibration measurement during which the subject is supine (Paragraph 0114-0118, wherein the posture function 840/900 determines the sub-postures of the patient with reference to the accelerometer measurements).
Regarding claims 10-11, Dieken discloses a method for determining a sleep posture of a subject, comprising:
determining a default craniocaudal rotation axis plane (Paragraph 0063-0065, wherein the accelerometer is arranged such that it maintains a proper orientation relative to the patient’s body);
receiving three-axis accelerometer signals from an accelerometer coupled to the subject (Fig. 1A, accelerometer based sensor 70; Paragraph 0071, “ in some examples the accelerometer sensor 360 comprises a multi-axis accelerometer such as a three-axis accelerometer”); and
determining, from a plurality of the three-axis acceleration signals over time and the default craniocaudal rotation axis plane, a reference craniocaudal rotation axis (Paragraph 0110 and 0114, wherein, in an alternate embodiment, the posture function determines whether the patient is lying down, standing up, or generally vertical based on the measured angles of the accelerometer; Paragraph 0194, wherein the system continuously tracks sleeping posture data);
calibrating a default orientation about the reference craniocaudal rotation axis within the default craniocaudal rotation axis plane by analyzing a spread of rotation angles over time (Paragraph 0114-0118, wherein the posture function 840/900 determines the sub-postures of the patient with reference to the accelerometer measurements. Examiner notes that these measurements would necessarily be based off of the proper arrangement/orientation of the accelerometers as described above and the initial posture determination; thus, they are based off of the “default craniocaudal rotation axis plane” and the “reference craniocaudal rotation axis”. In light of the 112(b) rejection and claim interpretation above, Dieken discloses measuring and defining a specific orientation of the user in the plane/rotation axis as previously described; thus, Dieken reads on the claim);
determining, for a first three-axis acceleration signal, a rotation angle about the reference craniocaudal rotation axis (Paragraph 0118, “Accordingly, the protocol performs a further classification via the pitch angle such that the patient is lying on their right side if the pitch angle is less than or equal to negative 45 degrees or greater than or equal to negative 135 degrees. However, the protocol determines that the patient is lying on their left side if the pitch angle is greater than or equal to 45 degrees or the pitch angle is less than or equal to 135 degrees. In some examples, a similar determination may be made using directional cosines” ; Examiner notes that the default orientation has not been changed by the calibration step. As such, the rotation angle about the reference craniocaudal axis would necessarily be relative to the default orientation);
determining the sleep posture of the subject based on the determined rotation angle (Paragraph 0114, “In the example, when such an angle is less than 40°, the measurement suggests the patient is in a generally vertical position, and therefore likely not asleep”; Paragraphs 0114-0118, wherein an angle of the accelerometer determines the posture of the subject); and
comparing the determined sleep posture to a first therapeutic sleep posture threshold, and responsive to the determined sleep posture being equal to the first therapeutic sleep posture threshold (Paragraph 0113, wherein the accelerometer measurement exceeds a gravity threshold; Paragraphs 0197-0198, wherein the system notifies the user to change sleep position to a position “more amenable” to respiration and the use of therapy device. Thus, the threshold is implied to be a position not amenable to respiration or with use of a therapy device), causing a user interface to provide vibratory feedback to the subject to initiate a sleep posture change (Paragraph 0197, “sleep position (obtained via a sensed posture information) may be communicated via a notification function 1440 to the patient during a sleep period in order to induce the patient to change their sleep position into one more conducive to efficacious therapy. In some examples, the communication via notification function 1440 may occur by an audible notification 1442 or haptic notification 1444 (e.g. vibratory, motion, etc.) implemented via wireless communication to a patient remote (e.g. 1030 in FIG. 12B), a user interface (e.g. 1034 in FIG. 12C), a patient support (e.g. 794 in FIG. 9C). In some examples, the haptic notification 1444 may be communicated via direct muscle stimulation via wireless communication to a wearable muscle stimulation device”), and wherein the controller is further adapted to track transitions between sleep postures over time based on the determined rotation angles (Paragraph 0194, “In some examples, posture information engine 1400 comprises a position tracking function 1420 to track physiologic information in association with at least some respective different postures. In some examples, the physiologic information comprises an amount of time spent sleeping in each posture. In some instances, such tracked physiologic information may include a number of switches between different postures”) and controlling actuation of the user interface in dependence on the determined sleep posture (Paragraph 0197).
Dieken fails to disclose taking a cross product vector of the acceleration measurement, inverting the vector, obtaining the reference craniocaudal rotation axis therefrom, and determining a reference craniocaudal rotation axis as a unity vector based on an average of the cross product vectors relative to the default orientation.
Dieken and Panken are analogous art as they are in the same field of posture determination. Panken teaches a posture sensing device and method of determining the orientation of a sensor (Abstract), wherein, by taking the cross-products of pairs of accelerometer measurements and normalizing the cross-products, determine a rotation axis (Paragraph 0017, “consider multiple postures that a patient may occupy while in the prone position. Such postures may include the Face Up, Face Down, Right Side, and Left Side postures. Each such posture may be associated with a defined posture vector that is obtained from a sensor as the patient assumes the posture (e.g., Face Up). The defined posture vectors may be grouped in adjacent pairs, where adjacency refers to how the vectors are positioned in space… Four adjacent pairs may be formed using the four postures of this example. A cross-product may be formed for each adjacent pair, resulting in a vector that is perpendicular to both of the defined posture vectors in the adjacent pair. Assuming all such cross-products are generated with the right-hand rule in mind so that the resulting vectors all have a same sign (positive or negative), these cross-products will all be in a same general direction. An average of these cross-products may be derived for use as a virtual posture vector in detecting a Lying Down posture”). Panken further teaches that an average of the cross-products is derived for use as a virtual posture vector (Paragraph 0017) and the posture vectors may be normalized with respect to one another to a same, known length Paragraph 0015). Per the 112(d) rejection above, the limitations of claim 11 are already required in claim 10; therefore, Dieken in view of Panken read on claim 11.
Dieken is concerned with determining postures of a patient to determine if they are asleep and what the sleep posture is. Panken is concerned with techniques of posture classification and discusses that this method allows for more accurate posture classification (Paragraph 0018). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Dieken to incorporate the method of determining a reference rotation axis taught by Panken to more accurately calculate/describe the posture of the user.
Regarding claim 12, Dieken as modified by Panken disclose the method of claim 10. Dieken further discloses wherein the controller is adapted to determine the head-to-toe direction of the reference craniocaudal axis relative to the subject by:
monitoring accelerations during sitting or standing (Paragraph 0193, “As previously noted, in at least some instances, the posture may sometimes be referred to as body position. As shown in FIG. 16, in some examples posture information engine 1400 comprises a calibration function 1410 to compensate for an unknown orientation of the accelerometer as mounted within the patient's body. In some examples, an automatic parameter 1412 performs such calibration automatically, such as when the patient is walking because such behavior is consistent with a gravity vector pointing downward”).
Regarding claim 14, Dieken as modified by Panken disclose the method of claim 10. Dieken further discloses that the controller is adapted to calibrate the default orientation about the reference craniocaudal rotation axis plane by obtaining a calibration measurement during which the subject is supine (Paragraph 0114-0118, wherein the posture function 840/900 determines the sub-postures of the patient with reference to the accelerometer measurements).
Regarding claim 15, Dieken as modified by Panken disclose the method of claim 10. Dieken further discloses a non-transitory computer readable medium having a computer program code stored thereon, that when said computer program code is executed on a computer, implements the method of claim 10 (Paragraph 0146, “In some examples, execution of the sequences of machine readable instructions, such as those provided via memory 1010 of control portion 1000 cause the processor to perform actions, such as operating controller 1002 to implement sleep disordered breathing (SDS) therapy and related management and/or management and operation of accelerometer-based sensing, as generally described in (or consistent with) at least some examples of the present disclosure”).
Regarding claim 16, Dieken as modified by Panken disclose the method of claim 1. Dieken further discloses wherein the default craniocaudal rotation axis plane is horizontal (Fig. 8B, axis orientation indicator 662).
Response to Arguments
Examiner acknowledges Applicant amending the claims to remove the recitation of an “alert system”. As such, the term is no longer interpreted under 35 U.S.C. §112(f).
Applicant's arguments, see page 7, filed 06/26/2026, with respect to the 35 U.S.C. §101 rejection, have been fully considered but they are not persuasive.
Applicant asserts that requiring the derivation of the reference craniocaudal rotation axis from a plurality of measured 3D gravity vectors through cross-product computation, inversion, and averaging and normalizing, the invention is not practically performable in the human mind. While Examiner agrees with the Applicant with regards to this limitation, this amended limitation is directed towards a mathematical concept. As such, the claims are still directed towards an abstract ide without integration into a practical application or significantly more. The claims remain rejected.
Applicant’s arguments, see pages 8-9, filed 06/26/2026, with respect to the 35 U.S.C. §112(a) rejection have been fully considered but are not persuasive. Applicant has removed recitation of the “alert system” and amended the claims to recite that the user interface is configured to provide “vibratory feedback”. However, as described above, the specification does not sufficiently describe how the vibratory feedback is provided nor what structure vibrates. Further, the specification only mentions “vibratory feedback” once in the background of the invention when describing other well-known electronic positional sleep therapy devices. As such, a 112(a) rejection has been applied with regard to the user interface providing vibratory feedback.
Applicant’s arguments, see page 9, filed 06/26/2026, with respect to the 35 U.S.C. §112(b) rejection have been fully considered and are partially persuasive.
Applicant has removed the limitation of an “alert system”. Therefore, the rejection is moot. However, a new rejection has been applied with regard to the “vibratory feedback”.
Applicant has amended the claims to further determine a rotation about the reference craniocaudal rotation axis relative to the calibrated default orientation. As such, the default orientation is not merely defined and calibrated but used in a calculation. Therefore, this rejection is withdrawn.
Applicant has provided no argument or amendment regarding what the “calibration measurement” is. The claim requires calibrating a default orientation about the reference craniocaudal rotation axis within the default craniocaudal rotation axis plane by at least one of obtaining a calibration measurement and analyzing a spread of rotation angles over time. However, it remains unclear how the calibration occurs. What changes about the default orientation? The claim does not require altering the default orientation with the calibration measurement or the spread of rotation angles over time. The claim merely requires “obtaining a calibration measurement” and “analyzing a spread of rotation angles”. Therefore, this rejection remains.
Applicant's arguments, see pages 9-11, filed 06/26/2026, with respect to the 35 U.S.C. §103 rejections have been fully considered but they are not persuasive.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Applicant asserts that Dieken and/or Panken do not suggest or disclose the limitations of deriving a reference craniocaudal rotation axis from a plurality of measured 3D gravity vectors by computing cross-product vectors, inverting the cross-product vectors, and averaging and normalizing to a unity reference axis. Applicant further asserts Dieken and/or Panken suggest or disclose calibrating a default orientation. Examiner respectfully disagrees.
Examiner points out that the calibration step refers to “a default orientation” about the reference craniocaudal rotation axis within the default craniocaudal rotation axis plane (i.e., a new, previously undefined orientation). There is no recitation of a calibration step to define a default craniocaudal rotation axis plane, rather, the plane is merely “determined”. Dieken discloses this step by selecting an arrangement of the accelerometer to align with an axis of the user (see Fig. 8b, orientation indicator 662). The “default orientation” can be defined as a sub-posture of a subject (i.e., supine position, a prone position, or in a lateral decubitus position [Paragraph 0116]). The sub-posture is determined based off of the initial arrangement of the accelerometer and the broad posture of the subject or the “default craniocaudal rotation axis” (i.e., standing up or lying down [Paragraph 0114]). Thus, Dieken discloses this limitation of claims 1 and 10.
In summary, Applicant has provided no argument as to why the instant application differs from the rejection of Dieken and/or Panken or why the prior art of record does not teach these limitations. Rather, Applicant merely states that Dieken and/or Panken fails to provide or suggest the claimed features. Examiner points to the rejection and the response to the arguments above. The combination of Dieken and Panken was used to reject claims 2-3 and 11 in the Non-Final Rejection filed 04/01/2026. Applicant has added the limitations of those claims into independent claims 1 and 10; however, Applicant has not addressed these rejections with any arguments. Therefore, the claims rejection remains.
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.
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/NOAH M HEALY/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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