DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2023 was considered by the examiner.
Claim Objections
Claims 1, 7, and 14 are objected to because of the following informalities:
Claim 1, line 2: “mounting” should be replaced with –being mounted–;
Claim 1, lines 3-4: “wherein for the medical device three orthogonal axes (XD, YD, ZD) and for the patient’s body three orthogonal axes (XP, YP, ZP) are defined” is grammatically awkward should be replaced with –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– or the like;
Claim 1, line 11: “an” should be deleted;
Claim 1, lines 11, 16, 35: “orientation" should be replaced with –orientations–;
Claim 1, line 18: a comma should be inserted after (H);
Claim 1, line 27: “and to” should be replaced with a comma;
Claim 1, line 42: “its” should be replaced with –the–;
Claim 6, line 4: “determined” should be deleted;
Claim 7, line 2: “mounting” should be replaced with –being mounted–;
Claim 7, lines 3-4: “wherein for the medical device three orthogonal axes (XD, YD, ZD) and for the patient’s body three orthogonal axes (XP, YP, ZP) are defined” is grammatically awkward should be replaced with –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– or the like;
Claim 7, line 12: “an” should be deleted;
Claim 7, lines 12, 17, 339: “orientation" should be replaced with –orientations–;
Claim 7, line 47: “its” should be replaced with –the–; and
Claim 14, line 1: “a computer program” should be replaced with –the computer program–.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“Accelerator unit” in claims 1 and 7 because it uses a generic placeholder (i.e., unit) that is coupled with functional language (i.e., “accelerator” and “configured to determine 3-dimensional proper acceleration data along sensitive axes corresponding to the three orthogonal axes of the medical device (XD, YD, ZD)”) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
The Examiner notes that the term “accelerator”, in the field of acceleration monitoring, is not understood to be associated with any structure. Therefore, the term is being interpreted to be functional language, and “accelerator unit” is being interpreted to mean “unit for accelerating”.
The specification does not provide sufficient structure for performing the function of “accelerator” or accelerating. For the purposes of examination, the claim limitation is being interpreted to correspond to an accelerometer or combination of accelerometers, as described in ¶¶ [0026], [0085] of the published application, and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “proper acceleration data” in line 5, which is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this case, one of ordinary skill in the art would not understand what “proper acceleration data” means, and the specification does not clearly define the term. Additionally, it is unclear when acceleration data starts/stops being considered proper/improper. Claim 7 recites the same indefinite term in lines 5-6, so claim 7 is being rejected for the same reasons. The examiner suggests deleting the recitations of “proper”.
Claim 1 recites “sensitive axes” in line 6. It is unclear what “sensitive axes” are. The examiner suggests deleting the term “sensitive”. Claim 7 recites the same indefinite term, so claim 7 is being rejected for the same reasons.
Claim 1 recites “one axis (ZD) of the medical device” in line 14 and “three orthogonal axes (XD, YD, ZD)” in lines 3-4. It is unclear whether the “one axis (ZD)” of line 14 is one of the three orthogonal axes of lines 3-4. The differences in terminology and the parentheses makes it unclear whether they are the same as or different from each other. For the purposes of examination, the recitation of “one axis (ZD) of the medical device” will be interpreted to be “the axis ZD of the medical device”. The recitations of “one axis (ZD) of the medical device” of lines 38-39 and 47-48 and the dependent claims will be interpreted accordingly. Claim 7 recites similar limitations, so claim 7 is being rejected for the similar reasons.
Claim 1 recites “the corresponding axis (ZP) of the patient’s body” in lines 14-15 and “three orthogonal axes (XP, YP, ZP)” in line 4. It is unclear whether the “the corresponding axis (ZP)” of lines 14-15 is one of the three orthogonal axes of line 4. The differences in terminology and the parentheses makes it unclear whether they are the same as or different from each other. For the purposes of examination, the recitation of “the corresponding axis (ZP) of the patient’s body” will be interpreted to be “the axis ZP of the patient’s body”. The recitations of “the corresponding axis (ZP) of the patient’s body” of lines 39-40 and 48-49 and the dependent claims will be interpreted accordingly. Claim 7 recites similar limitations, so claim 7 is being rejected for the similar reasons.
Claim 1 recites “the time point” in line 21 and “the transition” in line 22. There are insufficient antecedent bases for these limitations in the claim. For the purposes of examination, the recitations will be interpreted to be “a time point” and “a transition”, respectively. Claim 7 recites the same limitations, so claim 7 is rejected for the same reasons.
Claim 1 recites “or receive a second group” in line 23 and “and to calculate at least on specific acceleration data” in lines 27-28. Due to the structure of the claim, it is unclear whether the recitation of “and to calculate at least one specific acceleration data” in lines 27-28 is an optional or required limitation. The Examiner suggests the clarifying that it is a required step by placing it in a separate subparagraph.
Claim 1 recites “the specific acceleration data” in lines 31-32. Claim 1 also recites “at least one specific acceleration data” in lines 27-28. If there are plurality of specific acceleration data, it is unclear which of the plurality is being referred to by “the specific acceleration data” in lines 31-32. For the purposes of examination, the recitation in lines 31-32 will be interpreted to be “the at least one specific acceleration data”. Claim 7 recites the same limitations, so claim 7 is rejected for the same reasons.
Claims 2-6 are rejected by virtue of their dependence from claim 1. Claims 8-14 are rejected by virtue of their dependence from claim 1.
Claim 3 recites “from all read at least one specific acceleration data of the third time interval a median acceleration data is determined” in lines 2-3. The recitation is so grammatically awkward that the meaning is unclear. What does “all” refer to? What is being “read”? How is “read” and “determined” related? Additionally, it is unclear how “at least one specific acceleration data” is related to the recitation in lines 27-28 of claim 1. Are they the same as, related to, or different from each other? For the purposes of examination, the recitation in claim 3 will be interpreted to be “the at least one specific acceleration data comprises a determined median acceleration data”. Claim 9 recites a similar limitation, so claim 9 is rejected on similar grounds.
Claim 4 recites “the newest acceleration data” in line 4. There is insufficient antecedent basis for this limitation in the claim. The Examiner suggests deleting “the” in the limitation. Claim 10 recites a similar limitation, so claim 10 is rejected on similar grounds.
Claim 7 recites “receiving one or both of the following:” in line 20 and “calculating at least one specific acceleration data from one or both of the first group of acceleration data or the second group of acceleration data and transferring the at least one specific acceleration data to the data memory unit for storage” in lines 30-34. The structure of claim 7 indicates that the calculating and transferring steps of lines 30-34 are a part of the receiving of line 20. However, it is unclear how a receiving data can comprise calculating and transferring steps. The Examiner suggests amending claim 7 to clarify that the calculating and transferring steps are different from the receiving step.
Claims 1 and 7 recite “an accelerator unit” in line 2. The term “accelerator”, in the field of acceleration monitoring, is not understood to be associated with any structure. Therefore, the term “accelerator” is being interpreted to be functional language, and “accelerator unit” is being interpreted to mean “unit for accelerating”. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Specifically, the specification indicates that the accelerator unit corresponds to an accelerometer or combination of accelerometers in ¶¶ [0026], [0085] of the published application. However, the specification is completely devoid of any structure associated with the unit that is capable of “accelerating”. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because a computer program product does not have a physical or tangible form and amounts to “software per se”. See MPEP 2106.03 (I).
Claims 1-14 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 for the medical device three orthogonal axes (XD, YD, ZD) and for the patient’s body three orthogonal axes (XP, YP, ZP) are defined;
[B1]: differentiate between an active state and a rest state of the patient’s body;
[C1]: determine an actual orientation (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 one axis (ZD) of the medical device and the corresponding axis (ZP) of the patient’s body;
[D1]: wherein, in order to determine 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), performing: (i) receive a first group of said acceleration data determined by the accelerator unit 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 receive a second group of said acceleration data determined by the accelerator unit within a second predefined time interval that lies immediately before the time point for which the processor identifies the transition from the rest state to the active state of the patient's body and to calculate at least one specific acceleration data from the first group of acceleration data or the second group of acceleration data, (ii) read the specific acceleration data from all groups of said acceleration data that were determined by the accelerator 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
[E1]: in order to determine the actual yaw-angle (F) between the one axis (ZD) of the medical device and the corresponding axis (ZP) of the patient's body, performing: (i) determine whether the patient's body performs a predefined specific activity in its active state, (ii) receive said acceleration data continuously determined by the accelerator 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 one 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;
[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 mounting on a patient’s body comprising an accelerator unit, a data memory unit and a processor which are electrically interconnected, wherein the accelerator unit is configured to determine 3-dimensional proper acceleration data along sensitive 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 accelerator unit;
[B2]: transfer the at least one specific acceleration data to the data memory unit for storage; and
[C2]: read from the data memory unit.
The elements [A2]-[C2] 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 element [A2] does not integrate the exception into a practical application of the exception because the element amounts 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 mounting on a patient’s body comprising an accelerator unit, a data memory unit and a processor which are electrically interconnected, wherein the accelerator unit is configured to determine 3-dimensional proper acceleration data along sensitive 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 accelerator unit;
[B2]: transfer the at least one specific acceleration data to the data memory unit for storage; and
[C2]: read from the data memory unit.
The elements [A2]-[C2] 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) in ¶ [0072]. The element [C2] is well-understood, routine, and conventional as evidenced by US 5,469,861 A (Piscopo) in Col. 5, lines 43-57.
Additionally, the element [A2] does not amount to significantly more than the judicial exception itself because the element amounts 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 element is well-understood, routine, and conventional. US 2012/0232430 A1 (Boissy) teaches the element in ¶ [0051], US 2017/0043213 A1 (Daumer) teaches the element in ¶ [0030]; US 2013/0015976 A1 (Chang) teaches the element in ¶ [0012]. 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, 13, and 14 recite a mirrored method, computer program, and computer readable data carrier limitations and are not patent eligible for substantially similar reasons.
Claims 2-6 depend from claim 1, and they recite the same abstract idea as claim 1. Claims 8-14 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 the 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) 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.
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, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 6,044,297 A (Sheldon) in view of US 2016/0100776 A1 (Najafi), US 2018/0132793 A1 (Katra), and US 6,997,882 B1 (Parker).
With regards to claims 1 and 7, Sheldon teaches a method for determining an orientation of a medical device for implantation within or 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 accelerator 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 for the medical device three orthogonal axes (XD, YD, ZD) and for the patient’s body three orthogonal axes (XP,YP, ZP) are defined (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 accelerator unit is configured to determine 3-dimensional proper acceleration data along sensitive 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 accelerator 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 an 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 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, in order to determine 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) (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 accelerator unit corresponding to the rest state or receive a second group of said acceleration data determined by the accelerator 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 one 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 accelerator 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 accelerator 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 accelerator 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 accelerator 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 accelerator 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 claims 2 and 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 claims 3 and 9, the above combination is silent regarding all read 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 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 and 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 the 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 claims 6 and 12, the above combination teaches or suggests the processor is configured to determine 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)and determine 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).
With regards to claim 13, the above combination teaches or suggests a computer program product comprising 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).
With regards to claim 14, the above combination teaches or suggest a computer readable data carrier storing a computer program product according to claim 13 (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).
Claims 5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over US 6,044,297 A (Sheldon) in view of US 2016/0100776 A1 (Najafi), US 2018/0132793 A1 (Katra), and US 6,997,882 B1 (Parker), as applied to respective claims 1 and 7 above, and further in view of US 2014/0128778 A1 (Chan).
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.
Conclusion
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791