DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 9 and 17 are objected to because of the following informalities:
Claim 9, line 3: the open parenthesis before “of” should be deleted.
Claim 17, line 10: “ϕ” should be replaced with –F–.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No limitations are being interpreted under 35 U.S.C. 112(f).
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, 15, 16, and 18 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.
Claim 1 recites “upon identifying the active state based on the predefined activity threshold, determine, based on the acceleration data determined by the accelerometer unit, whether the patient’s body performs a predefined specific activity in the active state” in lines 44-47 and “upon determining that the patient’s body performs the predefined specific activity, actively capture and store said acceleration data continuously by the accelerometer over a predefined fourth time interval” in lines 48-51, which are new matter. The recitations indicate (A) the determination of whether the predefined specific activity is being performed occurs after the identification of the active state and (B) that the active capture and storage of the acceleration data occurs after the determination of the patient’s body performing the predefined specific activity, both of which are not supported by the specification. There are no teachings or suggestions within the specification that there is an order to the above steps.
Claims 2-6, 15, 16, and 18 are rejected by virtue of their dependence from claim 1.
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 1-13 and 15-18 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. Claims 1-14 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019), and the 2024 Guidance Update on Patent Subject Matter Eligibility (Federal Register, Vol. 89, No. 137 p. 58128, July 17, 2024).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is directed to a machine, which is a statutory category
Step 2A - Prong 1: Claim 1 is directed to an abstract idea in the form of a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components.
In particular, claim 1 recites the following limitations:
[A1]: wherein three orthogonal axes XD, YD, ZD are defined for the medical device and three orthogonal axes XP, YP, ZP are defined for the patient’s body;
[B1]: differentiate between an active state and a rest state of the patient’s body by processing the acceleration data determined by the accelerometer unit and comparing a value derived therefrom to a predefined activity threshold;
[C1]: determine actual orientations (θx, θy, θz) of the three orthogonal axes of the medical device XD, YD, ZD with regard to a horizontal plane (H) or determine an actual yaw-angle (F) between the axis ZD of the medical device and the corresponding axis ZP of the patient’s body;
[D1]: wherein, in order to determine the actual orientations (θx, θy, θz) of the three orthogonal axes of the medical device XD, YD, ZD with regard to the horizontal plane (H), performing: (i) receive a first group of said acceleration data determined by the accelerometer unit within a first predefined time interval that lies immediately after a first time point at which the processor identifies the transition from the active state to the rest state of the patient's body or receive a second group of said acceleration data determined by the accelerometer unit within a second predefined time interval that lies immediately before a second time point for which the processor identifies the transition from the rest state to the active state of the patient's body, (ii) calculate at least one specific acceleration data from the first group of acceleration data or the second group of acceleration data, (iii) read the at least one specific acceleration data from all groups of said acceleration data that were determined by the accelerometer unit within a third predefined time interval, and (iv) determine the actual orientations of the three orthogonal axes of the medical device XD, YD, ZD with regard to the horizontal plane based on the at least one specific acceleration data
[E1]: in order to determine the actual yaw-angle (F) between the axis ZD of the medical device and the corresponding axis ZP of the patient's body, performing: (i) upon identifying the active state based on the predefined activity threshold, determine, based on the acceleration data determined by the accelerometer unit, whether the patient's body performs a predefined specific activity in the active state, (ii) determining that the patient’s body performs the predefined specific activity, receive said acceleration data continuously determined by the accelerometer unit over a predefined fourth time interval during performance of the predefined specific activity by the patient's body, and (iii) determine the actual yaw-angle between the axis ZD of the medical device and the corresponding axis ZP of the patient's body based on the continuously determined acceleration data of the fourth time interval.
These elements [A1]-[E1] of claim 1 are directed to an abstract idea because they are processes that, under their broadest reasonable interpretation, are mere steps that are capable of being mentally performed with the aid of pen and paper. For example, a skilled artisan is capable of:
[A1] mentally defining axes of a medical device and a patient’s body;
[B1] mentally differentiating between active and rest states of the patient by comparing an acceleration parameter with a threshold;
[C1] mentally calculating an actual orientation or a yaw angle based on acceleration measurements;
[D1] mentally reading acceleration data with time intervals corresponding to rest states, a transition period, and an active state, mentally calculating medians and averages of the acceleration data, mentally reading acceleration data in a third predefined time interval, and mentally determining the orientation of the medical device based on the acceleration data; and
[E1] mentally determining whether the patient is walking based on the acceleration data, continuously read the acceleration data, and calculate a yaw angle based on the acceleration data.
Step 2A - Prong Two: Claim 1 does not recite additional elements that integrate the judicial exception into a practical application. Claim 1 recites the following additional elements:
[A2]: a medical device for implantation within or being mounted on a patient’s body comprising an accelerometer unit, a data memory unit and a processor which are electrically interconnected, wherein the accelerometer unit is configured to determine 3-dimensional acceleration data along axes corresponding to the three orthogonal axes of the medical device XD, YD, ZD and the processor is configured to process said acceleration data determined by the accelerometer unit;
[B2]: transfer the at least one specific acceleration data to the data memory unit for storage;
[C2]: read from the data memory unit; and
[D2]: actively capture and store said acceleration data continuously by the accelerometer unit.
The elements [A2]-[D2] do not integrate the exception into a practical application of the exception.
The elements [A2]-[C2] do not integrate the exception into a practical application of the exception because the elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - See MPEP 2106.04(d) and MPEP 2106.05(f).
Additionally, the elements [A2] and [D2] do not integrate the exception into a practical application of the exception because the elements amount to (A) adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP §§ 2106.04(d), 2106.05(g); and/or (B) generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP §§ 2106.04(d), 2106.05(h).
Accordingly, each of the additional elements do not integrate the abstract into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. Claim 1 recites the following additional elements:
[A2]: a medical device for implantation within or being mounted on a patient’s body comprising an accelerometer unit, a data memory unit and a processor which are electrically interconnected, wherein the accelerometer unit is configured to determine 3-dimensional acceleration data along axes corresponding to the three orthogonal axes of the medical device XD, YD, ZD and the processor is configured to process said acceleration data determined by the accelerometer unit;
[B2]: transfer the at least one specific acceleration data to the data memory unit for storage;
[C2]: read from the data memory unit; and
[D2]: actively capture and store said acceleration data continuously by the accelerometer unit.
The elements [A2]-[D2] do not amount to significantly more than the judicial exception itself.
Simply reciting the elements [A2]-[C2] not qualify as significantly more because these elements 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 MPEP 2106.05(d)(II); Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network)) 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 MPEP 2106.05(d)(II); Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93). Additionally, the element [B2] is well-understood, routine, and conventional as evidenced by US 2019/0269352 A1 (Brown) (previously cited) in ¶ [0072]. The element [C2] is well-understood, routine, and conventional as evidenced by US 5,469,861 A (Piscopo) (previously cited) in Col. 5, lines 43-57.
Additionally, the elements [A2] and [D2] do not amount to significantly more than the judicial exception itself because the elements amount to (A) adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g); and/or (B) generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h). Furthermore, the elements are well-understood, routine, and conventional. US 2012/0232430 A1 (Boissy) (previously cited) teaches the elements in ¶¶ [0051], [0062], US 2017/0043213 A1 (Daumer) (previously cited) teaches the elements in ¶¶ [0030]-[0031]; US 2013/0015976 A1 (Chang) (previously cited) teaches the elements in ¶¶ [0012], [0081], [0084]-[0085]. The plurality of disclosures is evidence of the well-understood, routine, and conventional nature of the element.
In view of the above, the additional elements individually 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.
Claims 7 and 13 recite a mirrored method and computer-readable medium limitations and are not patent eligible for substantially similar reasons.
Claims 2-6, 15-16, and 18 depend from claim 1, and they recite the same abstract idea as claim 1. Claims 8-13 and 17 depend from claim 7, and they recite the same abstract idea as claim 7. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process or mathematical algorithm) and/or append abstract ideas (that is, the claims only recite limitations that add further mental processes or mathematical algorithms) except for the following limitations.
Claim 4 recites “the data memory unit is configured such that said acceleration data are continuously stored in a circular buffer for a predefined fifth time interval, wherein acceleration data which are older than the fifth time interval are overwritten by newest acceleration data”. However the above element does not integrate the exception into a practical application of the exception or qualify as significantly more because the element amount to merely adding insignificant extra-solution activity to the judicial exception, - see MPEP 2106.04(d); MPEP 2106.05(g). Additionally, the element is well-understood, routine, and conventional. US 2015/0087949 A1 (Felix) (previously cited) in ¶ [0007] which discloses that conventionally, Holter monitor can overwrite older ECG tracings, which indicates that the overwriting data in a circular buffer is well-understood, routine, and conventional. Claim 10 recites similar elements that do not integrate the exception into a practical application of the exception or qualify as significantly more for similar reasons.
Claim 18 recites extracting frequency-domain features from the acceleration data corresponding to the axis ZD. However the above element does not integrate the exception into a practical application of the exception or qualify as significantly more because the element amount to merely adding insignificant extra-solution activity to the judicial exception, - see MPEP 2106.04(d); MPEP 2106.05(g). Additionally, the element is well-understood, routine, and conventional. US 2015/0351688 A1 (Just) discloses in ¶ [0133] that there are many examples known to those skilled in the art for utilizing the characteristic multi-axis accelerometer output signals—i.e., the intensities, frequencies, and/or transient responses of multiple accelerometers placed in different locations—measured during a characteristic motion for characterizing different types of movement.
In view of the above, the additional elements do not integrate the abstract idea 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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The 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 1-4, 6-10, 12-14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US 6,044,297 A (Sheldon) (previously cited) in view of US 2016/0100776 A1 (Najafi) (previously cited), US 2018/0132793 A1 (Katra) (previously cited), US 2019/0365290 A1 (Lee) and US 6,997,882 B1 (Parker) (previously cited).
With regards to claim 1, Sheldon teaches a method for determining an orientation of a medical device for implantation within or being mounting on a patient’s body (Abstract and Col. 6, lines 4-12 depict a method and apparatus for determining the physical posture of a patient’s body using accelerometers; Figs. 1-3 and Col. 9, lines 36-53 depict an IMD housing configured to be implanted in a patient’s body 90) comprising an accelerometer unit, a data memory unit and a processor which are electrically interconnected (Figs. 1-3 and Col. 9, lines 36-53 depict accelerometers 72, 74, 76; Col. 21, lines 32-43 and Col.9, lines 13-35 depict a microcomputer circuit 34, microprocessor 54, and RAM 64 or RAM/ROM unit 68 for use with implementing the algorithm, which indicates that the elements are electrically interconnected), wherein three orthogonal axes XD, YD, ZD are defined for the medical device and three orthogonal axes XP,YP, ZP are defined for the patient’s body (Figs. 3-6 and Col. 13, lines 33-43 depict the X, Y, and Z device axes 82, 84, 86 and the patient’s L-M, S-I, and A-P body axes 92, 94, 96 being defined), wherein the accelerometer unit is configured to determine 3-dimensional acceleration data along axes corresponding to the three orthogonal axes of the medical device XD, YD, ZD (Col. 9, lines 36-53 depict the axes of DC accelerometers 72, 74, and 76 are orthogonally directed to one another and are aligned with the X, Y, and Z device axes 82, 84, and 86) and the processor is configured to process said acceleration data determined by the accelerometer unit (Col. 21, lines 32-43 and Col.9, lines 13-35 depict a microcomputer circuit 34, microprocessor 54, and RAM 64 or RAM/ROM unit 68 for use with implementing the algorithm, which indicates that 34 and/or 54 are configured to process the acceleration data), wherein the processor is configured to:
differentiate between an active state and a rest state of the patient’s body (Col. 5, lines 33-38 depict distinguishing postures or position attitude of the patient at rest and at levels of exercise);
determine actual orientation (θx, θy, θz) of the three orthogonal axes of the medical device XD, YD, ZD with regard to a horizontal plane (Fig. 8 and Col. 15, lines 43-61 depict calculation of actual pitch angle ϕx, yaw angle ϕy, and roll angle ϕ-z through steps S200-S208, wherein Figs. 4-6 depict the angles are made with respect to the ideal X, Y, Z axes which includes a horizontal plane X-Y) or determine an actual yaw-angle (F) between the axis ZD of the medical device and the corresponding axis ZP of the patient’s body (Figs. 4 and 8 and Col. 15, lines 43-61 depict calculation of actual yaw angle ϕy which is between the Z axis of the device and the Z ideal axis);
wherein, in order to determine the actual orientations (θx, θy, θz) of the three orthogonal axes of the medical device XD, YD, ZD with regard to the horizontal plane (H) (Figs. 4 and 8 and Col. 15, lines 43-61), the processor is configured to:
(i) receive a first group of said acceleration data determined by the accelerometer unit corresponding to the rest state or receive a second group of said acceleration data determined by the accelerometer unit corresponding to the rest state (Fig. 8 and Col. 15, lines 43-61 depict acquiring a-x’’, ay’’, az’’ during supine posture; also see Col. 20, lines 11-67 with regards to the acquisition of the set of acceleration signals)
in order to determine the actual yaw-angle (F) between the axis ZD of the medical device and the corresponding axis ZP of the patient's body, the processor is configured to: (i) determine whether the patient's body performs a predefined specific activity in its active state (Col. 5, lines 33-38 depict distinguishing postures or position attitude of the patient at rest and at levels of exercise; also see Col. 22, lines 4-9 with regards to the detection of standing, which is a activity in an upright state), (ii) receive said acceleration data continuously determined by the accelerometer unit during performance of the predefined specific activity by the patient's body (Fig. 8 and Col. 15, lines 43-60 and Col. 20, lines 11-35 depict acquisition of accelerometer output signals while the patient is upright and standing), and (iii) determine the actual yaw-angle between the one axis ZD of the medical device and the corresponding axis ZP of the patient's body based on the continuously determined acceleration data (Fig. 8 and Col. 15, lines 43-60 and Col. 20, lines 11 to Col. 21, line 31 depicts calculation of the yaw angle based on the signals while the patient is upright and standing).
Sheldon is silent regarding whether (A) the first group of said acceleration data is within a first predefined time interval that lies immediately after a first time point for which the processor identifies the transition from the active state to the rest state of the patient's body or (B) the second group of said acceleration data is within a second predefined time interval that lies immediately before a second time point for which the processor identifies the transition from the active state to the rest state of the patient's body. Additionally, Sheldon is silent regarding (ii) calculate at least one specific acceleration data from the first group of acceleration data or the second group of acceleration data and transfer the at least one specific acceleration data to the data memory unit for storage.
In a system relevant to the problem of detecting acceleration data of rest periods, Najafi teaches (A) receiving a first group of acceleration data within a first predefined time interval that lies immediately after the time point for which the processor identifies the transition from the active state to the rest state of the patient's body or (B) receiving a second group of said acceleration data within a second predefined time interval that lies immediately before the time point for which the processor identifies the transition from the active state to the rest state of the patient's body (Fig. 6 and ¶¶ [0081]-[0089] depict identification of a postural transition duration Linitial and Lterminal, determining an average value of an acceleration in the three seconds before and after the transition duration). Additionally, Najaf teaches calculating at least one specific acceleration data from the first group of acceleration data or the second group of acceleration data (¶ [0087] discloses calculation of the average value of the acceleration). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the acquisition of the acceleration data during the rest period of Sheldon to incorporate (A) receiving a first group of acceleration data within a first predefined time interval that lies immediately after the time point for which the processor identifies the transition from the active state to the rest state of the patient's body or (B) receiving a second group of said acceleration data within a second predefined time interval that lies immediately before the time point for which the processor identifies the transition from the active state to the rest state of the patient's body, and calculating at least one specific acceleration data from the first group of acceleration data or the second group of acceleration data as taught by Najafi. Because both methods are capable of determining acceleration data during a rest period, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the acquisition of the average acceleration would provide a more robust depiction of the accelerations acquired during the rest period.
The above combination is silent regarding whether the and transfer the at least one specific acceleration data to the data memory unit for storage, (iii) read from the data memory unit the at least one specific acceleration data from all groups of said acceleration data that were determined by the accelerometer unit within a third predefined time interval.
In a system relevant to the problem of storing and accessing acceleration data, Katra teaches transferring at least one specific acceleration data to the data memory unit for storage (¶¶ [0039], [0041], [0047] disclose accelerometer sign/data generated over a predetermined period of time being stored in memory), reading from the data memory unit the specific acceleration data from all groups of said acceleration data that were determined by the accelerometer unit within a third predefined time interval (¶ [0039] discloses that the data from the predetermined period of time and the prospective accelerometer signals may be available for analysis, wherein the 30 minutes which covers the predetermined period of time and the prospective accelerometer signals amounts to a third predefined time interval; ¶ [0047] discloses analysis and/or monitoring the physiological data). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate transferring at least one specific acceleration data to the data memory unit for storage, reading from the data memory unit the at least one specific acceleration data from all groups of said acceleration data that were determined by the accelerometer unit within a third predefined time interval as taught by Katra. The motivation would have been to allow all the stored data to be available for analysis, as the clinical relevance of the information may not be determinable until a period of time in the future (¶ [0039] of Katra).
The above combination is silent regarding (iii) determine the actual orientation of the three orthogonal axes of the medical device XD, YD, ZD with regard to the horizontal plane based on the at least one specific acceleration data.
In the same field of endeavor of calibrating accelerometer axes to bodily axes, Parker teaches averaging accelerometer data during postures associated with rest states and active states (Col. 19, lines 52-67 depict averaging accelerometer data to minimize the effects of noise and involuntary movements during supine and upright poses) and determining the actual orientation of the three orthogonal axes of the medical device (XD, YD, ZD) with regard to the horizontal plane based on the specific acceleration data (Claim 1 and Col. 19, line 26 to Col. 21, line 17 depict determining an orientation of the accelerometers with respect of the x, y, and z-axes of anatomical reference-frame based on the average accelerations, wherein the reference frame includes the x-y plane). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate that determining the actual orientation of the three orthogonal axes of the medical device XD, YD, ZD with regard to the horizontal plane based on the at least one specific acceleration data as taught by Parker. Because both acceleration data are capable of being used for calibrating accelerometers, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to improve the determination by minimizing the effects of noise and involuntary movements (Col. 19, lines 52-67 of Parker).
The above combination is silent regarding differentiating between an active state and a rest state of the patient’s body by processing the acceleration data determined by the accelerometer unit and comparing a value derived therefrom to a predefined activity threshold, and upon identifying the active state based on the predefined activity threshold, determine, based on the acceleration data determined by the accelerometer unit, whether the patient’s body performs a predefined specific activity in the active state.
In a system relevant to the problem of determining postural states, Lee teaches differentiating between an active state and a rest state of the patient’s body by processing the acceleration data determined by the accelerometer unit and comparing a value derived therefrom to a predefined activity threshold (Fig. 11 and ¶ [0182] discloses differentiating between lying down posture and upright postures at steps 514, 516 based on a comparison of a scalar dot product of accelerometer signals with a set of thresholds), and upon identifying the active state based on the predefined activity threshold, determine, based on the acceleration data determined by the accelerometer unit, whether the patient’s body performs a predefined specific activity in the active state (Fig. 11 and ¶ [0183] discloses upon determining that the patient is not in a lying down posture (and is upright), the processor may compare the scalar product to one or more thresholds to determine whether the patient is standing upright, upside down or sitting). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate differentiating between an active state and a rest state of the patient’s body by processing the acceleration data determined by the accelerometer unit and comparing a value derived therefrom to a predefined activity threshold, and upon identifying the active state based on the predefined activity threshold, determine, based on the acceleration data determined by the accelerometer unit, whether the patient’s body performs a predefined specific activity in the active state as taught by Lee. The motivation would have been to automate the determination of the upright standing posture, thereby improving the ease of use of the device.
The above combination is silent regarding whether upon determining that the patient’s body performs the predefined specific activity, actively capture and store said acceleration data continuously determined over a predefined fourth time interval during performance of the predefined specific activity by the patient’s body.
In the same field of endeavor of calibrating accelerometer axes to bodily axes, Parker teaches upon determining that the patient’s body performs the predefined specific activity, actively capture and store said acceleration data continuously determined over a predefined fourth time interval during performance of the predefined specific activity by the patient’s body (Col. 19, lines 52-60 depict acquiring accelerations once a patient assumes different stances for short periods of time (e.g., about 30 sec), wherein the different stances include standing upright). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the acquisition of the acceleration data of the above combination to incorporate that it is determined continuously over a predefined fourth time interval during performance of the predefined specific activity by the patient’s body as taught by Parker. The motivation would have been to provide enough data points for the determination of the posture-related parameters.
With regards to claim 2, the above combination teaches or suggests that the at least one specific acceleration data derived from one or both of the first group of acceleration data or the second group of acceleration data is an average of the respective group of acceleration data (Claim 1 and Col. 19, line 26 to Col. 21, line 17 of Parker depict the calculation of the average acceleration).
With regards to claim 3, the above combination is silent regarding from at least one specific acceleration data of the third time interval, a median acceleration data is determined and the actual orientation (θx, θy, θz) of the three orthogonal axes of the medical device XD, YD, ZD with regard to the horizontal plane (H) is calculated from the determined median acceleration data.
In the same field of endeavor of calibrating accelerometer axes to bodily axes, Parker teaches a median acceleration data is determined (Col. 20, lines 5-11 depict determination of a median acceleration of poses) and the actual orientations (θx, θy, θz) of the three orthogonal axes of the medical device XD, YD, ZD with regard to the horizontal plane (H) is calculated from the determined median acceleration data (Col. 19, line 26 to Col. 21, line 17 depict determining an orientation of the accelerometers with respect of the x, y, and z-axes of anatomical reference-frame based on the median acceleration). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified determination of the actual orientation of the above combination to incorporate the use of a median acceleration as taught by Parker. Because both average and median accelerations are statistical measures which are capable of being used minimizing the effects of noise and involuntary movements in acceleration data, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 4, the above combination is silent regarding whether the data memory unit is configured such that said acceleration data are continuously stored in a circular buffer for a predefined fifth time interval, wherein acceleration data which are older than the fifth time interval are overwritten by newest acceleration data.
In a system relevant to the problem of storing and accessing acceleration data, Katra teaches data memory unit configured such that said acceleration data are continuously stored in a circular buffer for a predefined fifth time interval, wherein acceleration data which are older than the fifth time interval are overwritten by newest acceleration data (¶ [0041] of Katra teaches a looping memory in which accelerometer signals generated from a period of about the last 30 minutes may be continuously sampled and stored in memory, with the oldest signals that have been stored being discarded and/or replaced over time). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the data memory unit of the above combination to incorporate that it is configured such that said acceleration data are continuously stored in a circular buffer for a predefined fifth time interval, wherein acceleration data which are older than the fifth time interval are overwritten by the newest acceleration data as taught by Katra. Because both memory unit configurations are capable of storing clinically relevant data, it would have been the simple substitution of known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to provide data that may be useful where a clinically relevant episode has already passed (¶ [0044] of Katra).
With regards to claim 6, the above combination teaches or suggests the processor is configured to determine an actual posture of the patient based on the actual orientation (θx, θy, θz) of the three orthogonal axes of the medical device XD, YD, ZD with regard to the horizontal plane (H) (see the above combination of claim 1; see Fig. 8 and Col. 15, lines 43-61 of Sheldon which depict calculation of actual pitch angle ϕx, yaw angle ϕy, and roll angle ϕ-z through steps S200-S208, wherein Figs. 4-6 of Sheldon depict the angles are made with respect to the ideal X, Y, Z axes which includes a horizontal plane X-Y; also see Col. 16, lines 31-42 which indicates that corrected accelerometer output signals are compared to stored thresholds to determine actual body posture) and the determined the actual yaw-angle (F) between one axis (ZD) of the medical device and the corresponding axis (ZP) of the patient’s body (see the above combination of claim 1; see Figs. 4 and 8 and Col. 15, lines 43-61 of Sheldon which depict calculation of actual yaw angle ϕy which is between the Z axis of the device and the Z ideal axis; also see Col. 16, lines 31-42 which indicates that corrected accelerometer output signals are compared to stored thresholds to determine actual body posture).
With regards to claim 18, the Examiner notes that “wherein the processor is further configured to determine the actual yaw-angle by extracting frequency-domain features from the acceleration data corresponding to the axis ZD during the predefined specific activity and comparing the extracted frequency-domain features to a step frequency of the predefined specific activity” of claim 18 is an optional limitation because claim 1 recites “(ii) determine actual orientations (θx, θy, θz) of the three orthogonal axes of the medical device XD, YD, ZD with regard to a horizontal plane (H) or determine an actual yaw-angle (F) between the axis ZD of the medical device and the corresponding axis ZP of the patient’s body” in lines 14-18. Therefore, the optional feature of claim 18 does not limit the scope of the claim under the broadest reasonable claim interpretation. Because the feature of claim 18 are optional and the above combination of Sheldon in view of Najafi, Katra, Lee and Parker teaches or suggests the determination of the actual orientations (θx, θy, θz) of claim 1, the above combination covers the claim scope of claim 18. See MPEP 2111.04(I), 2143.03.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over US 6,044,297 A (Sheldon) (Previously cited) in view of US 2016/0100776 A1 (Najafi) (Previously cited), US 2018/0132793 A1 (Katra) (Previously cited), US 2019/0365290 A1 (Lee), and US 6,997,882 B1 (Parker) (Previously cited), as applied to claim 1 above, and further in view of US 2014/0128778 A1 (Chan) (Previously cited).
The above combination is silent regarding whether the specific activity is walking.
In the same field of endeavor of calibrating accelerometers, Chan teaches a specific activity for determining a yaw-angle between an axis of the medical device and the corresponding axis of the patient’s body is walking (¶ [0054] depicts calibrating an accelerometer using a rotation matrix during standing/walking). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of the yaw-angle to incorporate that it is based on acceleration data performed during walking as taught by Chan. Because both standing and walking are suitable activities for performing yaw-angle calibration, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claims 7-10, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US 6,044,297 A (Sheldon) (previously cited) in view of US 2016/0100776 A1 (Najafi) (Previously cited), US 2018/0132793 A1 (Katra) (Previously cited), and US 6,997,882 B1 (Parker) (Previously cited).
With regards to claim 7, Sheldon teaches a method for determining an orientation of a medical device for implantation within or being mounted on a patient’s body (Abstract and Col. 6, lines 4-12 depict a method and apparatus for determining the physical posture of a patient’s body using accelerometers; Figs. 1-3 and Col. 9, lines 36-53 depict an IMD housing configured to be implanted in a patient’s body 90) comprising an accelerometer unit, a data memory unit and a processor which are electrically interconnected (Figs. 1-3 and Col. 9, lines 36-53 depict accelerometers 72, 74, 76; Col. 21, lines 32-43 and Col.9, lines 13-35 depict a microcomputer circuit 34, microprocessor 54, and RAM 64 or RAM/ROM unit 68 for use with implementing the algorithm, which indicates that the elements are electrically interconnected), wherein three orthogonal axes XD, YD, ZD are defined for the medical device and three orthogonal axes XP,YP, ZP are defined for the patient’s body (Figs. 3-6 and Col. 13, lines 33-43 depict the X, Y, and Z device axes 82, 84, 86 and the patient’s L-M, S-I, and A-P body axes 92, 94, 96 being defined), wherein the accelerometer unit is configured to determine 3-dimensional acceleration data along axes corresponding to the three orthogonal axes of the medical device XD, YD, ZD (Col. 9, lines 36-53 depict the sensitive axes of DC accelerometers 72, 74, and 76 are orthogonally directed to one another and are aligned with the X, Y, and Z device axes 82, 84, and 86) and the processor is configured to process said acceleration data determined by the accelerometer unit (Col. 21, lines 32-43 and Col.9, lines 13-35 depict a microcomputer circuit 34, microprocessor 54, and RAM 64 or RAM/ROM unit 68 for use with implementing the algorithm, which indicates that 34 and/or 54 are configured to process the acceleration data), wherein the processor:
differentiates between an active state and a rest state of the patient’s body (Col. 5, lines 33-38 depict distinguishing postures or position attitude of the patient at rest and at levels of exercise);
determines an actual orientations (θx, θy, θz) of the three orthogonal axes of the medical device XD, YD, ZD with regard to a horizontal plane (Fig. 8 and Col. 15, lines 43-61 depict calculation of actual pitch angle ϕx, yaw angle ϕy, and roll angle ϕ-z through steps S200-S208, wherein Figs. 4-6 depict the angles are made with respect to the ideal X, Y, Z axes which includes a horizontal plane X-Y) or determine an actual yaw-angle (F) between one axis ZD of the medical device and the corresponding axis ZP of the patient’s body (Figs. 4 and 8 and Col. 15, lines 43-61 depict calculation of actual yaw angle ϕy which is between the Z axis of the device and the Z ideal axis);
wherein the actual orientations (θx, θy, θz) of the three orthogonal axes of the medical device XD, YD, ZD with regard to the horizontal plane (H) (Figs. 4 and 8 and Col. 15, lines 43-61) is determined by the processor with the following steps:
(i) receiving a first group of said acceleration data determined by the accelerometer unit corresponding to the rest state or receiving a second group of said acceleration data determined by the accelerometer unit corresponding to the rest state (Fig. 8 and Col. 15, lines 43-61 depict acquiring a-x’’, ay’’, az’’ during supine posture; also see Col. 20, lines 11-67 with regards to the acquisition of the set of acceleration signals)
wherein the actual yaw-angle (F) between the one axis ZD of the medical device and the corresponding axis ZP of the patient's body is determined by the processor with the following steps: (i) determine whether the patient's body performs a predefined specific activity in the active state (Col. 5, lines 33-38 depict distinguishing postures or position attitude of the patient at rest and at levels of exercise; also see Col. 22, lines 4-9 with regards to the detection of standing, which is a activity in an upright state), (ii) receive said acceleration data continuously determined by the accelerometer unit during performance of the predefined specific activity by the patient's body (Fig. 8 and Col. 15, lines 43-60 and Col. 20, lines 11-35 depict acquisition of accelerometer output signals while the patient is upright and standing), and (iii) determine the actual yaw-angle between the one axis ZD of the medical device and the corresponding axis ZP of the patient's body based on the continuously determined acceleration data (Fig. 8 and Col. 15, lines 43-60 and Col. 20, lines 11 to Col. 21, line 31 depicts calculation of the yaw angle based on the signals while the patient is upright and standing).
Sheldon is silent regarding whether (A) the first group of said acceleration data is within a first predefined time interval that lies immediately after the time point for which the processor identifies the transition from the active state to the rest state of the patient's body or (B) the second group of said acceleration data is within a second predefined time interval that lies immediately before the time point for which the processor identifies the transition from the active state to the rest state of the patient's body. Additionally, Sheldon is silent regarding calculating at least one specific acceleration data from the first group of acceleration data or the second group of acceleration data and transfer the at least one specific acceleration data to the data memory unit for storage, (ii) read from the data memory unit the specific acceleration data from all groups of said acceleration data that were determined by the accelerometer unit within a third predefined time interval, and (iii) determine the actual orientation of the three orthogonal axes of the medical device (XD, YD, ZD) with regard to the horizontal plane based on the specific acceleration data.
In a system relevant to the problem of detecting acceleration data of rest periods, Najafi teaches (A) receiving a first group of acceleration data within a first predefined time interval that lies immediately after the time point for which the processor identifies the transition from the active state to the rest state of the patient's body or (B) receiving a second group of said acceleration data within a second predefined time interval that lies immediately before the time point for which the processor identifies the transition from the active state to the rest state of the patient's body (Fig. 6 and ¶¶ [0081]-[0089] depict identification of a postural transition duration Linitial and Lterminal, determining an average value of an acceleration in the three seconds before and after the transition duration). Additionally, Najaf teaches calculating at least one specific acceleration data from the first group of acceleration data or the second group of acceleration data (¶ [0087] discloses calculation of the average value of the acceleration). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the acquisition of the acceleration data during the rest period of Sheldon to incorporate (A) receiving a first group of acceleration data within a first predefined time interval that lies immediately after the time point for which the processor identifies the transition from the active state to the rest state of the patient's body or (B) receiving a second group of said acceleration data within a second predefined time interval that lies immediately before the time point for which the processor identifies the transition from the active state to the rest state of the patient's body, and calculating at least one specific acceleration data from the first group of acceleration data or the second group of acceleration data as taught by Najafi. Because both methods are capable of determining acceleration data during a rest period, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the acquisition of the average acceleration would provide a more robust depiction of the accelerations acquired during the rest period.
The above combination is silent regarding whether the and transfer the at least one specific acceleration data to the data memory unit for storage, (ii) read from the data memory unit the specific acceleration data from all groups of said acceleration data that were determined by the accelerometer unit within a third predefined time interval.
In a system relevant to the problem of storing and accessing acceleration data, Katra teaches transferring at least one specific acceleration data to the data memory unit for storage (¶¶ [0039], [0041], [0047] disclose accelerometer sign/data generated over a predetermined period of time being stored in memory), reading from the data memory unit the specific acceleration data from all groups of said acceleration data that were determined by the accelerometer unit within a third predefined time interval (¶ [0039] discloses that the data from the predetermined period of time and the prospective accelerometer signals may be available for analysis, wherein the 30 minutes which covers the predetermined period of time and the prospective accelerometer signals amounts to a third predefined time interval; ¶ [0047] discloses analysis and/or monitoring the physiological data). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate transferring at least one specific acceleration data to the data memory unit for storage, reading from the data memory unit the specific acceleration data from all groups of said acceleration data that were determined by the accelerometer unit within a third predefined time interval as taught by Katra. The motivation would have been to allow all the stored data to be available for analysis, as the clinical relevance of the information may not be determinable until a period of time in the future (¶ [0039] of Katra).
The above combination is silent regarding determining the actual orientation of the three orthogonal axes of the medical device (XD, YD, ZD) with regard to the horizontal plane based on the specific acceleration data.
In the same field of endeavor of calibrating accelerometer axes to bodily axes, Parker teaches averaging accelerometer data during postures associated with rest states and active states (Col. 19, lines 52-67 depict averaging accelerometer data to minimize the effects of noise and involuntary movements during supine and upright poses) and determining the actual orientation of the three orthogonal axes of the medical device (XD, YD, ZD) with regard to the horizontal based on the specific acceleration data (Claim 1 and Col. 19, line 26 to Col. 21, line 17 depict determining an orientation of the accelerometers with respect of the x, y, and z-axes of anatomical reference-frame based on the average accelerations, wherein the reference frame includes the x-y plane). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate that determining the actual orientation of the three orthogonal axes of the medical device (XD, YD, ZD) with regard to the horizontal based on the average acceleration data as taught by Parker. Because both acceleration data are capable of being used for calibrating accelerometers, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to improve the determination by minimizing the effects of noise and involuntary movements (Col. 19, lines 52-67 of Parker).
The above combination is silent regarding whether the acceleration data is continuously determined over a predefined fourth time interval during performance of the predefined specific activity by the patient’s body.
In the same field of endeavor of calibrating accelerometer axes to bodily axes, Parker teaches acceleration data is continuously determined over a predefined fourth time interval (Col. 19, lines 52-60 depict acquiring accelerations while a patient assumes different stances for short periods of time (e.g., about 30 sec). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the acquisition of the acceleration data of the above combination to incorporate that it is determined continuously over a predefined fourth time interval during performance of the predefined specific activity by the patient’s body as taught by Parker. The motivation would have been to provide enough data points for the determination of the posture-related parameters.
With regards to claim 8, the above combination teaches or suggests that the at least one specific acceleration data derived from one or both of the first group of acceleration data or the second group of acceleration data is an average of the respective group of acceleration data (Claim 1 and Col. 19, line 26 to Col. 21, line 17 of Parker depict the calculation of the average acceleration).
With regards to claim 9, the above combination is silent regarding whether from at least one specific acceleration data of the third time interval, a median acceleration data is determined and the actual orientation (θx, θy, θz) of the three orthogonal axes of the medical device XD, YD, ZD with regard to the horizontal plane (H) is calculated from the determined median acceleration data.
In the same field of endeavor of calibrating accelerometer axes to bodily axes, Parker teaches a median acceleration data is determined (Col. 20, lines 5-11 depict determination of a median acceleration of poses) and the actual orientation (θx, θy, θz) of the three orthogonal axes of the medical device (XD, YD, ZD) with regard to the horizontal plane (H) is calculated from the determined median acceleration data (Col. 19, line 26 to Col. 21, line 17 depict determining an orientation of the accelerometers with respect of the x, y, and z-axes of anatomical reference-frame based on the median acceleration). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified determination of the actual orientation of the above combination to incorporate the use of a median acceleration as taught by Parker. Because both average and median accelerations are statistical measures which are capable of being used for minimizing the effects of noise and involuntary movements in acceleration data, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 10, the above combination is silent regarding whether the data memory unit is configured such that said acceleration data are continuously stored in a circular buffer for a predefined fifth time interval, wherein acceleration data which are older than the fifth time interval are overwritten by newest acceleration data.
In a system relevant to the problem of storing and accessing acceleration data, Katra teaches data memory unit configured such that said acceleration data are continuously stored in a circular buffer for a predefined fifth time interval, wherein acceleration data which are older than the fifth time interval are overwritten by the newest acceleration data (¶ [0041] of Katra teaches a looping memory in which accelerometer signals generated from a period of about the last 30 minutes may be continuously sampled and stored in memory, with the oldest signals that have been stored being discarded and/or replaced over time). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the data memory unit of the above combination to incorporate that it is configured such that said acceleration data are continuously stored in a circular buffer for a predefined fifth time interval, wherein acceleration data which are older than the fifth time interval are overwritten by the newest acceleration data as taught by Katra. Because both memory unit configurations are capable of storing clinically relevant data, it would have been the simple substitution of known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to provide data that may be useful where a clinically relevant episode has already passed (¶ [0044] of Katra).
With regards to claim 12, the above combination teaches or suggests an actual posture of the patient is determined by the processor based on the determined the actual orientations (θx, θy, θz) of the three orthogonal axes of the medical device XD, YD, ZD with regard to the horizontal plane (H) (see the above combination of claim 1 with regards to the determination of the upright posture; see Fig. 8 and Col. 15, lines 43-61 of Sheldon which depict calculation of actual pitch angle ϕx, yaw angle ϕy, and roll angle ϕ-z through steps S200-S208, wherein Figs. 4-6 of Sheldon depict the angles are made with respect to the ideal X, Y, Z axes which includes a horizontal plane X-Y; also see Col. 16, lines 31-42 which indicates that corrected accelerometer output signals are compared to stored thresholds to determine actual body posture) and the determined the actual yaw-angle (F) between the axis ZD of the medical device and the corresponding axis ZP of the patient’s body (see the above combination of claim 1; see Figs. 4 and 8 and Col. 15, lines 43-61 of Sheldon which depict calculation of actual yaw angle ϕy which is between the Z axis of the device and the Z ideal axis; also see Col. 16, lines 31-42 which indicates that corrected accelerometer output signals are compared to stored thresholds to determine actual body posture).
With regards to claim 13, the above combination teaches or suggests a non-transitory computer-readable medium storing instructions which, when executed by a processor, cause the processor to perform the steps of the method according to claim 7 (See the above combination regarding the method of claim 7; Col. 12, lines 43-32 of Sheldon depict implementing the present invention using the software stored in ROM 33 and/or RAM 64 and associated RAM/ROM unit 68 of the microcomputer circuit 34; Col. 21, lines 41-42 of Sheldon depict a MATLAB program for implementing the correction for roll, pitch, and yaw).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over US 6,044,297 A (Sheldon) (Previously cited) in view of US 2016/0100776 A1 (Najafi) (Previously cited), US 2018/0132793 A1 (Katra) (Previously cited), and US 6,997,882 B1 (Parker) (Previously cited), as applied to claim 7 above, and further in view of US 2014/0128778 A1 (Chan) (Previously cited).
The above combination is silent regarding whether the specific activity is walking.
In the same field of endeavor of calibrating accelerometers, Chan teaches a specific activity for determining a yaw-angle between an axis of the medical device and the corresponding axis of the patient’s body is walking (¶ [0054] depicts calibrating an accelerometer using a rotation matrix during standing/walking). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of the yaw-angle to incorporate that it is based on acceleration data performed during walking as taught by Chan. Because both standing and walking are suitable activities for performing yaw-angle calibration, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over US 6,044,297 A (Sheldon) (Previously cited) in view of US 2016/0100776 A1 (Najafi) (Previously cited), US 2018/0132793 A1 (Katra) (Previously cited), US 2019/0365290 A1 (Lee), and US 6,997,882 B1 (Parker) (Previously cited), as applied to claim 1 above, and further in view of US 2013/0190008 A1 (Vathsangam).
With regards to claim 15, the above combination is silent regarding whether the processor is configured to determine a step frequency by identifying which of the three orthogonal axes of the medical device XD, YD, ZD is most aligned with the YP axis of the patient's body based on the determined actual orientations (θx, θy, θz), and calculating a fundamental frequency of the acceleration data from the identified axis during the predefined specific activity.
In the same field of endeavor of medical devices comprising accelerometer units, Vathsangam teaches determining a step frequency by identifying which of the three orthogonal axes of the medical device XD, YD, ZD is most aligned with the vertical axis (¶ [0054] discloses, depending on the orientation, selecting time series accelerometer data that corresponds to movement in the vertical direction in order to determine a period of a walk or step frequency) , and calculating a fundamental frequency of the acceleration data from the identified axis during the predefined specific activity (¶ [0054] discloses determining a highest peak in the fast Fourier transform signal, wherein this peak corresponds to an average step frequency). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of the above combination to incorporate, based on the teachings of Vathsangam, to incorporate that it is configured to determine a step frequency by identifying which of the three orthogonal axes of the medical device XD, YD, ZD is most aligned with the YP axis of the patient's body based on the determined actual orientations (θx, θy, θz), and calculating a fundamental frequency of the acceleration data from the identified axis during the predefined specific activity. The motivation would have been to provide a more complete diagnostic analysis of the patient.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over US 6,044,297 A (Sheldon) (Previously cited) in view of US 2016/0100776 A1 (Najafi) (Previously cited), US 2018/0132793 A1 (Katra) (Previously cited), US 2019/0365290 A1 (Lee), and US 6,997,882 B1 (Parker) (Previously cited), as applied to claim 6 above, and further in view of US 2015/0164410 A1 (Selvaraj)
With regards to claim 16, the above combination is silent regarding whether the processor is further configured to calculate a percentage of time the patient is in an upright posture versus a laying down posture based on the determined actual posture, and to use the calculated percentage as a health status indicator.
In a system relevant to the problem of determining patient health statuses, Selvaraj teaches calculating a percentage of time the patient is in an upright posture versus a laying down posture based on the determined actual posture (¶ [0072] discloses determining a percentage of time supine vs upright), and to use the calculated percentage as a health status indicator (¶ [0073] discloses using the features in a machine learning unit; ¶ [0020] discloses determining if the user has a sleep apnea syndrome (SAS) disorder using the machine learning unit). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate calculating a percentage of time the patient is in an upright posture versus a laying down posture based on the determined actual posture, and to use the calculated percentage as a health status indicator as taught by Selvaraj. The motivation would have been to provide a more complete diagnostic analysis of the patient.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over US 6,044,297 A (Sheldon) (Previously cited) in view of US 2016/0100776 A1 (Najafi) (Previously cited), US 2018/0132793 A1 (Katra) (Previously cited), and US 6,997,882 B1 (Parker) (Previously cited), as applied to claim 12 above, and further in view of US 2015/0157242 A1 (Sabesan)
With regards to claim 17, the above combination is silent regarding whether determining the actual posture of the patient comprises: measuring acceleration data from the accelerometer unit while the patient's body is in the rest state, calculating current orientations (ax,ay,az) of the three orthogonal axes of the medical device XD, YD, ZD with regard to the horizontal plane based on the measured acceleration data, and determining the actual posture based on a difference between the current orientations (ax,ay,az) and the determined actual orientations (θx, θy, θz), and based on the determined actual yaw-angle (F).
In the same field of endeavor of determining body postures, Sabesan teaches determining the actual posture of the patient comprises: measuring acceleration data from the accelerometer unit while the patient's body is in the rest state, calculating current orientations (ax,ay,az) of the three orthogonal axes of the medical device XD, YD, ZD with regard to the horizontal plane based on the measured acceleration data, and determining the actual posture based on a difference between the current orientations (ax,ay,az) and the predetermined baseline orientations (¶ [0035] discloses providing a baseline orientation of the subject while the subject is in a known posture (recumbent or upright) in an initial calibration, and calculating offset angles between the subject axes to determine whether the subject is in a recumbent or an upright position in subsequent positions; ¶ [0033] discloses using at least three axes to detect the position of the subject). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of the actual posture of the patient of the above combination to incorporate, based on the teachings of Sabesan, measuring acceleration data from the accelerometer unit while the patient's body is in the rest state, calculating current orientations (ax,ay,az) of the three orthogonal axes of the medical device XD, YD, ZD with regard to the horizontal plane based on the measured acceleration data, and determining the actual posture based on a difference between the current orientations (ax,ay,az) and the determined actual orientations (θx, θy, θz), and based on the determined actual yaw-angle (F). The motivation would have been to provide a more accurate determination of postures after the initial calibration.
Response to Arguments
Claim Objections
There are new grounds of claim objections necessitated by the claim amendments field 05/12/2026.
Rejections under 35 U.S.C. §112
There are new grounds of rejections under 35 U.S.C. §112(a) necessitated by the claim amendments field 05/12/2026.
Rejections under 35 U.S.C. §101
The rejection of claim 13 for being directed to “software per se” was withdrawn in view of the claim amendments filed 05/12/2026.
Applicant's arguments filed 05/12/2026 regarding the rejection of claims 1-14 for being directed to an abstract idea without significantly more have been fully considered but they are not persuasive.
On page 12 of the remarks filed 05/12/2026, the Applicant asserts:
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Applicant further asserts that the situation is analogous to SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319, 94 USPQ2d 1607 (Fed. Cir. 2010) because the machine is necessary for data gathering. Page 12 of the remarks filed 05/12/2026.
These arguments are not persuasive. First, the Applicant’s arguments are not commensurate with the scope of the claim language because the claims do not indicate that there is “real-time processing of 3-dimensional acceleration data”. Second, the Examiner maintains that the use of the physical accelerometer sensor to capture and store data amounts to mere data gathering, which is insignificant extra-solution activity. See example (vi) of the mere data gathering examples of MPEP 2106.05(g) which includes assessing or measuring data derived from an ultrasound scan, which the courts have found to be insignificant extra-solution activity. Finally, the Examiner maintains that the analysis of the obtained accelerometer data can be performed mentally for the reasons listed in the above rejection and because there is no indication within the specification or the claims which prevents above elements from being a mental process. The assertion that a person cannot mentally compare derived values to thresholds amounts to mere attorney argument without persuasive evidence.
On page 13 of the remarks filed 05/12/2026, the Applicant asserts:
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These arguments are not persuasive.
First, the Examiner asserts that the alleged improvement is in the mental process (i.e., the abstract idea) of determining an actual yaw angle. MPEP 2106.05(a) indicates that “the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” MPEP 2106.05(a)(II) further recites “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology”. The claimed invention merely includes gathering and analyzing information using conventional techniques, which is similar to TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48 of MPEP 2106.05(a)(II) and does not amount to an improvement to technology.
Second, the alleged improvement is based on the determination of the yaw angle, which is an optional limitation. Therefore, the scope of the claim does not reflect the alleged improvement. Specifically, claim 1 recites “(ii) determine actual orientations (θx, θy, θz) of the three orthogonal axes of the medical device XD, YD, ZD with regard to a horizontal plane (H) or determine an actual yaw-angle (F) between the axis ZD of the medical device and the corresponding axis ZP of the patient’s body” in lines 14-18. The optional limitation does not limit the scope of the claim under the broadest reasonable claim interpretation. See MPEP 2111.04(I), 2143.03.
Rejections under 35 U.S.C. §103
There are new grounds of rejections of claim 1 necessitated by the claim amendments filed 05/12/2026.
To the extent that the Applicant’s arguments are applicable to the current rejections, the Examiner makes the following comments.
Applicant's arguments filed 05/12/2026 have been fully considered but they are not persuasive.
On page 15 of the remarks filed 05/12/2026, the Applicant asserts:
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Applicant provides similar arguments regarding claim 7 on page 16 of the remarks filed 05/12/2026.
These argument is not persuasive. The Examiner maintains that Shelby teaches determining a yaw angle during a detected specific activity because Shelby teaches, in Fig. 8 and Col. 15, lines 43-60 and Col. 20, lines 11 to Col. 21, line 31, calculation of the yaw angle based on the signals while the patient is upright and standing. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., non-static exercises such as walking) are not recited in the rejected claims 1 and 7. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In this case, claim language merely indicates that the acceleration data for determining the yaw angle corresponds to performance of the predefined specific activity. However, the broadest reasonable interpretation of a “specific activity” includes being upright and standing.
Claims 5 and 11 indicate that the specific activity is walking. However, the Applicant does not provide any arguments regarding the references used in the rejections of claims 5 and 11 explaining how the claims avoid the references or distinguish from them.
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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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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