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 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 claim limitations have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1, 8, and 16 are objected to because of the following informalities:
in claim 1, line 13: “a” should be inserted before “memory”;
in claim 1, line 22: “the” should be inserted before “number”;
in claim 8, line 8: “a” should be inserted before “memory”;
in claim 16, line 16: “the” should be inserted before “number”; and
in claim 16, line 17: “the” should be inserted before “interstitial fluid”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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 “A device to determine a level of interstitial swelling in a subject” in line 1, but it is not clear how the device of claim 1 carries out its intended function since no claim element seems to be used in the determination of “a level of interstitial swelling in a subject”. At best, the device of claim 1 seems to result in the determination of “a first circumference representing the volume of interstitial fluid based on the length of strap unwrapped from the spool”, which is not the same thing. This ambiguity as to the capability of the device of claim 1 renders claim 1 indefinite.
Claim 1 recites “a strap-wrapped spool” in line 18, but it is not clear if this spool is the same as, related to, or different from “a spool” of claim 1, line 7. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation of “the spool” should make it clear which recitation is being referred to.
Claim 1 recites “the number of rotations” in line 20 and “the volume of interstitial fluid” in line 23 in which there are insufficient antecedent bases for these recitations in the claim.
Claims 2-7 are rejected by virtue of their dependence from claim 1.
Claim 2 recites “a magnetic sensor” in line 2, but it is not clear if this sensor is the same as, related to, or different from “a first magnetic sensor” of claim 1, line 12. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation of “the magnetic sensor” should make it clear which recitation is being referred to.
Claim 2 recites “the rate of interrupts” in line 4 in which there is insufficient antecedent basis for this recitations in the claim.
Claims 3-4 are rejected by virtue of their dependence from claim 2.
Claim 3 depends from itself, which renders the claim indefinite since it is not clear what the metes and bounds of the claim are when it depends from itself. For the purposes of examination, claim 3 will be considered to depend from claim 2.
Claim 4 is rejected by virtue of its dependence from claim 3.
Claim 4 recites “wherein the predefined state is an advertise mode” in line 1, which contradicts the recitation “wherein the predefined state is a wake mode” in claim 3, line 1. This contradiction renders claim 4 indefinite.
Claim 5 recites “a magnetic sensor” in line 2 and “a magnetic sensor” in line 4, but it is not clear if this sensor is the same as, related to, or different from each other and/or “a first magnetic sensor” of claim 1, line 12. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation of “the magnetic sensor” should make it clear which recitation is being referred to.
Claim 5 recites “wherein in response to detecting an interrupt associated with a full rotation of the spool, the number of rotations is confirmed using the angle of the spool determined from the angular position” in lines 5-7, which is an action step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)). Additionally, it is not clear which structure is associated with this action.
Claim 8 recites “A computer-implemented method to determine an increase or decrease of interstitial volume in a subject” in lines 1-2, but it is not clear how the method of claim 8 carries out its intended function since no claim element seems to be used in the determination of “an increase or decrease of interstitial volume in a subject”. At best, the method of claim 8 seems to result in the determination of “determining a level of interstitial swelling based on the length”, which is not the same thing. This ambiguity as to the capability of the method of claim 8 renders claim 8 indefinite.
Claim 8 recites “a magnetic sensor” in lines 7-8, but it is not clear if this sensor is the same as, related to, or different from “one or more magnetic sensors” of claim 8, line 3. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation of “the magnetic sensor” should make it clear which recitation is being referred to.
Claim 8 recites “a strap-wrapped spool” in line 13, but it is not clear if this spool is the same as, related to, or different from “a spool” of claim 8, line 5. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation of “the spool” should make it clear which recitation is being referred to.
Claim 8 recites “the amount of the strap wrapped around the spool” in lines 18-19, but it is not clear if this recitation is the same as, related to, or different from “a length of the wrapped strap around the spool” of claim 8, line 17. They seem to be alluding to the same thing, but they use different phraseology. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear. Also, if they are different, there is insufficient antecedent basis for “the amount of the strap wrapped around the spool” in claim 8.
Claims 9-15 are rejected by virtue of their dependence from claim 8.
Claim 9 recites “the circumference of the strap on the wrapped spool” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a first circumference of the wrapped spool” of claim 8, line 16 and/or “a first diameter of a strap-wrapped spool” of claim 8, line 13. They seem to be alluding to the same thing, but they use different phraseology. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear. Also, if they are different, there is insufficient antecedent basis for “the circumference of the strap on the wrapped spool” in claim 9.
Claim 10 is rejected by virtue of its dependence from claim 9.
Claim 13 recites “the circumference of the strap on the wrapped spool” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a first circumference of the wrapped spool” of claim 8, line 16 and/or “a first diameter of a strap-wrapped spool” of claim 8, line 13. They seem to be alluding to the same thing, but they use different phraseology. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear. Also, if they are different, there is insufficient antecedent basis for “the circumference of the strap on the wrapped spool” in claim 13.
Claim 14 is rejected by virtue of its dependence from claim 13.
Claim 15 recites “the patient” in line 3, but it is not clear if this recitation is the same as, related to, or different from “a subject” of claim 8, line 2. They seem to be alluding to the same thing, but they use different phraseology. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear. Also, if they are different, there is insufficient antecedent basis for “the patient” in claim 15.
Claim 16 recites “cause the one or more processors to perform operations to determine an increase or decrease of interstitial volume in a subject” in lines 2-3, but it is not clear how the method of claim 16 carries out its intended function since no claim element seems to be used in the determination of “an increase or decrease of interstitial volume in a subject”. At best, the method of claim 16 seems to result in the determination of “determining a first circumference representing the volume of interstitial fluid in the subject based on the length of strap unwrapped from the spool”, which is not the same thing. This ambiguity as to the capability of the operation of claim 16 renders claim 16 indefinite.
Claim 16 recites “a magnetic sensor” in line 8 and “the first magnetic sensor” in line 12, but it is not clear if these sensors are the same as, related to, or different from each other or the “one or more magnetic sensors” of claim 16, line 4. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation of “the magnetic sensor” should make it clear which recitation is being referred to. Also, if they are different, there is insufficient antecedent basis for “the first magnetic sensor” in claim 16.
Claim 16 recites “memory” in line 9, but it is not clear if this memory is the same as, related to, or different from “One or more non-transitory computer-readable media” of claim 16, line 1. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear and they should be clearly distinguished from each other.
Claim 16 recites “the strap-wrapped spool” in line 13, but it is not clear if this spool is the same as, related to, or different from “a spool” of claim 16, line 6. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation of “the spool” should make it clear which recitation is being referred to. Also, if they are different, there is insufficient antecedent basis for “the strap-wrapped spool” in claim 16.
Claim 16 recites “the number of rotations” in line 14 and “the volume of interstitial fluid” in line 17 in which there are insufficient antecedent bases for these recitations in the claim.
Claims 17-20 are rejected by virtue of their dependence from claim 16.
Claim 17 recites “a magnetic sensor” in line 2, but it is not clear if this sensor is the same as, related to, or different from “one or more magnetic sensors” of claim 16, line 4; “a magnetic sensor” in claim 16, line 8; and “the first magnetic sensor” in claim 16, line 12. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation of “the magnetic sensor” should make it clear which recitation is being referred to.
Claims 18-19 are rejected by virtue of their dependence from claim 17.
Claim 20 recites “the determining of the level of interstitial swelling” in line 3 in which there are insufficient antecedent bases for “the level of interstitial swelling” and for “the determining of the level of interstitial swelling” in the claim. Also, it is not clear how “the determining of the level of interstitial swelling” comes about since it has not been previously mentioned in the claim.
Claim 20 recites “the patient” in line 4, but it is not clear if this recitation is the same as, related to, or different from “a subject” of claim 16, line 3. They seem to be alluding to the same thing, but they use different phraseology. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear. Also, if they are different, there is insufficient antecedent basis for “the patient” in claim 20.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 depends from itself which is improper.
Claim 4 is rejected by virtue of its dependence from claim 3.
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 16 is 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. Claim 16 is directed to a method of determining a first circumference representing the volume of interstitial fluid in the subject based on the length of strap unwrapped from the spool using a computational algorithm, which is an abstract idea. Claim 16 does not include additional elements that integrate the exception into a practical application 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), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 16 is as follows:
Step 1: Claim 16 is drawn to a machine.
Step 2A – Prong One: Claim 16 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] determining a first measurement of a first magnetic coupling between the first magnet and the first magnetic sensor;
[B1] determining a first angle of the strap-wrapped spool based on the first measurement;
[C1] determining the number of rotations of the spool;
[D1] determining a length of strap unwrapped from the spool based on the first angle and number of rotations of the spool; and
[E1] determining a first circumference representing the volume of interstitial fluid in the subject based on the length of strap unwrapped from the spool.
These elements [A1]-[E1] of claim 16 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations and/or (2) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 16 recites the following limitations that are beyond the judicial exception:
[A2] One or more non-transitory computer-readable media containing executable instructions that, if executed by one or more processors, cause the one or more processors to perform operations to determine an increase or decrease of interstitial volume in a subject…the operations comprising…
[B2] via one or more magnetic sensors in a winder cassette that includes a frame; a capture feature supported by the frame, the capture feature including a magnet; a spring supported by the capture feature; and a spool supported by the frame and surrounding the spring, the spool supporting the magnet; and a measurement assembly that includes an electronics subassembly, wherein the electronics subassembly includes measurement components including a magnetic sensor arranged to be magnetically couplable to the magnet; the one or more processors; and memory,
These elements [A2]-[B2] of claim 16 do not integrate the exception into a practical application of the exception. In particular, the element [A2] is merely an instruction 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). Further, the element [B2] merely recites elements that are not considered part of the claimed computer-readable media. That is, the element [B2] merely describes the nature of the data that is input into the algorithm.
Step 2B: Claim 16 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the element [A2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
The element [B2] does not qualify as significantly more because it merely recites elements that are not considered part of the claimed computer-readable media. That is, the element [B2] merely describes the nature of the data that is input into the algorithm.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over CA 3043505 (Harfouche), in view of U.S. Patent Application Publication No. 2022/0390220 (Tecu), and further in view of U.S. Patent No. 1,882,385 (Johnson), and further in view of U.S. Patent Application Publication No. 2012/0179067 (Wekell).
Harfouche discloses a device for measuring an object, comprising a winder of a measuring element arranged to form a loop about the object, which has at least one wall and an exit opening arranged to allow the exit of at least one unwound portion of the measuring element (abstract of Harfouche). The measuring device 1 comprises: a spring winder 2 designed to wind and unwind a measuring element 3 in the form of a tape made of a flexible material. The winder has an exit opening 4 designed to allow the exit of at least one unwound portion Pd of the measuring element 3. The unwound portion Pd is defined between the exit opening 4 and the distal end Ed of measuring element 3. A connecting means C of the distal end Ed of the measuring element 3 is located at a distance d from the exit opening 4 of the winder 2. The winder 2 has a reading window 6 comprising a marker 7 where the circumference can be read (page 13 of Harfouche).
Tecu teaches a tape and reel system including a spool 18 upon which the trailing section of a tape 12 is wound. The spool further includes magnets 56 disposed around the perimeter of the spool. The magnets 56 are received by a rotational sensor to provide information on the amount the reel has spun. The number of times the reel has spun is proportional to the amount of tape that has been deployed (i.e., length of tape or leading section). The rotational sensor is connected to an electronic module 6 such that the information on the amount the reel has spun is available to the processing unit (paragraphs 0023 and 0038 of Tecu). There is also a user interface 16 and a control circuit 30 so as to provide a digital readout of the length (paragraphs 0020-0021 and 0029-0036 of Tecu). Further, there is a zero-reference sensor so as to provide the zero-reference point for the measuring tape 12 so as to ensure the frame of reference for the unwinding (paragraphs 0040-0041 of Tecu). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the magnets on the spool, the rotational sensor, the zero-reference sensor, and the user interface with digital readout with the measuring device of Harfouche so as to provide for easier readout of the measuring distance and to reduce human error.
Also, Tecu teaches the use of a spring around which the spool is located (paragraph 0024 and FIG. 3 of Tecu). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a spring around which the spool is located since it increases in tension as the tape is deployed and may be employed to aid in retracting the tape (paragraph 0024 of Tecu).
Johnson teaches how a spring can be attached to a spool. In particular, Johnson teaches that the spool and spring can be attached to each other via a hole in the spring and a protrusion from the spool and that the frame and the spring can be attached to each other via a hole in the spring and a protrusion from the frame (page 2, lines 10-35 of Johnson; FIGS. 1 and 3 of Johnson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to attach the spring to the spool 18 of Tecu and attach the spring to the housing of the winder 2 of Harfouche in the manner suggested by Johnson since a method of assembly is required and Johnson teaches one such method and/or it is a simple substitution of one known element for another to obtain predictable results.
Tecu teaches the use of a control circuit 30 so as to provide a digital readout of the length (paragraphs 0020-0021 and 0029-0036 of Tecu). Wekell teaches that such control and computer devices use a system member 22 (paragraph 0207 of Wekell). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system memory of Wekell in the control circuitry 30 of Tecu so as to provide a mechanism for providing the programmed instructions to the control circuitry 30 of Tecu.
With respect to claim 1, the combination teaches or suggests device to determine a level of interstitial swelling in a subject, comprising:
a winder cassette that includes:
a frame (the housing of the winder 2 of Harfouche);
a capture feature supported by the frame, the capture feature including a drive pin (the pin at 20 of Johnson) and the drive pin having a first spring coupler (the pin at 20 of Johnson);
a spring (the spring 22 of Tecu) coupled to the capture feature via the first spring coupler; and
a spool (the spool 18 of Tecu) supported by the frame and surrounding the spring, the spool supporting a first magnet (the magnets 56 of Tecu) and having a second spring coupler (the pin at 21 of Johnson) via which the spool is coupled to the spring; and
a measurement assembly that includes an electronics subassembly, wherein the electronics subassembly includes: measurement components including a first magnetic sensor (the rotation sensors 54 of Tecu) arranged to be magnetically couplable to the first magnet; one or more processors (the control circuit 30 of Tecu); memory (the system memory of Wekell); and executable instructions stored in the memory that, if executed by the one or more processors, cause the one or more processors to perform operations comprising:
determining a first measurement of a first magnetic coupling between the first magnet and the first magnetic sensor (the first measurement between the rotational sensor and one of the magnets on the spool; paragraphs 0023 and 0038 of Tecu);
determining a first angle of a strap-wrapped spool based on the first measurement (the zero-reference sensor of Tecu during the first measurement is used to provide the zero-reference point for the measuring tape so as to ensure the zero angle of the spool is established; paragraphs 0040-0041 of Tecu);
determining the number of rotations of the spool (the determination of the number of time the reel has spun; paragraphs 0023 and 0038 of Tecu);
determining a length of strap unwrapped from the spool based on the first angle and number of rotations of the spool (the determination on the amount of tape that has been deployed; paragraphs 0023 and 0038 of Tecu);
determining a first circumference representing the volume of interstitial fluid based on the length of strap unwrapped from the spool (the determination of the circumference of the limb measured; page 14 of Harfouche).
With respect to claim 7, the combination teaches or suggests that the first spring coupler comprises a protrusion (the pin at 20 of Johnson) configured to couple to a corresponding first aperture (the aperture at 20 of Johnson) in the spring, and the second spring coupler is a protrusion (the pin at 21 of Johnson) configured to couple to a corresponding second aperture in the spring (the aperture at 21 of Johnson).
Claims 8-10, 15-16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Harfouche, in view of Tecu, and further in view of Wekell.
Harfouche discloses a device for measuring an object, comprising a winder of a measuring element arranged to form a loop about the object, which has at least one wall and an exit opening arranged to allow the exit of at least one unwound portion of the measuring element (abstract of Harfouche). The measuring device 1 comprises: a spring winder 2 designed to wind and unwind a measuring element 3 in the form of a tape made of a flexible material. The winder has an exit opening 4 designed to allow the exit of at least one unwound portion Pd of the measuring element 3. The unwound portion Pd is defined between the exit opening 4 and the distal end Ed of measuring element 3. A connecting means C of the distal end Ed of the measuring element 3 is located at a distance d from the exit opening 4 of the winder 2. The winder 2 has a reading window 6 comprising a marker 7 where the circumference can be read (page 13 of Harfouche).
Tecu teaches a tape and reel system including a spool 18 upon which the trailing section of a tape 12 is wound. The spool further includes magnets 56 disposed around the perimeter of the spool. The magnets 56 are received by a rotational sensor to provide information on the amount the reel has spun. The number of times the reel has spun is proportional to the amount of tape that has been deployed (i.e., length of tape or leading section). The rotational sensor is connected to an electronic module 6 such that the information on the amount the reel has spun is available to the processing unit (paragraphs 0023 and 0038 of Tecu). There is also a user interface 16 and the control circuit 30 so as to provide a digital readout of the length (paragraphs 0020-0021 and 0029-0036 of Tecu). Further, there is a zero-reference sensor so as to provide the zero-reference point for the measuring tape 12 so as to ensure the frame of reference for the unwinding (paragraphs 0040-0041 of Tecu). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the magnets on the spool, the rotational sensor, the zero-reference sensor, and the user interface with digital readout with the measuring device of Harfouche so as to provide for easier readout of the measuring distance and to reduce human error.
Also, Tecu teaches the use of a spring around which the spool is located (paragraph 0024 and FIG. 3 of Tecu). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a spring around which the spool is located since it increases in tension as the tape is deployed and may be employed to aid in retracting the tape (paragraph 0024 of Tecu).
Tecu teaches the use of a control circuit 30 so as to provide a digital readout of the length (paragraphs 0020-0021 and 0029-0036 of Tecu). Wekell teaches that such control and computer devices use a system member 22 (paragraph 0207 of Wekell). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system memory of Wekell in the control circuitry 30 of Tecu so as to provide a mechanism for implementing the programmed instructions of the control circuitry 30 of Tecu.
With respect to claim 8, the combination teaches or suggests a computer-implemented method to determine an increase or decrease of interstitial volume in a subject, the method comprising:
via one or more magnetic sensors (the rotation sensors 54 of Tecu) in a winder cassette that includes a frame (the housing of the winder 2 of Harfouche); a capture feature supported by the frame, the capture feature including a magnet (the magnets 56 of Tecu); a spring (the spring 22 of Tecu) supported by the capture feature; and a spool (the spool 18 of Tecu) supported by the frame and surrounding the spring, the spool supporting the magnet (the magnets 56 of Tecu); and a measurement assembly that includes an electronics subassembly, wherein the electronics subassembly includes measurement components including a magnetic sensor (the rotation sensors 54 of Tecu) arranged to be magnetically couplable to the magnet; one or more processors (the control circuit 30 of Tecu); memory (the system memory of Wekell); and executable instructions stored in the memory that, if executed by the one or more processors, cause the one or more processors to perform operations comprising:
determining a measurement of magnetic coupling between the magnet and the magnetic sensor (the first measurement between the rotational sensor and one of the magnets on the spool; paragraphs 0023 and 0038 of Tecu);
determining a first diameter of a strap-wrapped spool based on the measurement, the first diameter including a diameter of the spool itself plus a wrapped thickness of the strap wrapped on the spool (Tecu teaches that “Using a rotational sensor 54, the length of tape deployed is equivalent to the spiral circumference of the tape on the spool multiplied by the number of rotations. The term spiral circumference is used specifically in this application to account for the circumference and diameter of the tape increasing with every wind around the spool. Likewise, it should be understood that the circumference and diameter of the tape wrapped around the spool decreases as the length of deployed tape increases” (paragraph 0041 of Tecu). From this teaching, Tecu is disclosing that the payout of the tape from the spool is determined based on the rotations of the spool, the circumference of the spool, and the spiral circumference of the tape on the spool (that is, the circumference of the tape on the spool at any given point in the rotation). From these variables and geometric principles, one of ordinary skill in the art would have understood the necessary calculations to determine the payout of the tape by determining the rotations of the spool and the spiral circumference of the tape on the spool (that is, the circumference of the tape on the spool at any given point in the rotation), as suggested by Tecu, so as to achieve the goals set forth in Tecu);
determining a first circumference of the wrapped spool based on the first diameter (Tecu teaches that “Using a rotational sensor 54, the length of tape deployed is equivalent to the spiral circumference of the tape on the spool multiplied by the number of rotations. The term spiral circumference is used specifically in this application to account for the circumference and diameter of the tape increasing with every wind around the spool. Likewise, it should be understood that the circumference and diameter of the tape wrapped around the spool decreases as the length of deployed tape increases” (paragraph 0041 of Tecu). From this teaching, Tecu is disclosing that the payout of the tape from the spool is determined based on the rotations of the spool, the circumference of the spool, and the spiral circumference of the tape on the spool (that is, the circumference of the tape on the spool at any given point in the rotation). From these variables and geometric principles, one of ordinary skill in the art would have understood the necessary calculations to determine the payout of the tape by determining the rotations of the spool and the spiral circumference of the tape on the spool (that is, the circumference of the tape on the spool at any given point in the rotation), as suggested by Tecu, so as to achieve the goals set forth in Tecu);
determining a length of the wrapped strap around the spool based on the first circumference, the length being the full length of the strap minus the amount of the strap wrapped around the spool (Tecu teaches that “Using a rotational sensor 54, the length of tape deployed is equivalent to the spiral circumference of the tape on the spool multiplied by the number of rotations. The term spiral circumference is used specifically in this application to account for the circumference and diameter of the tape increasing with every wind around the spool. Likewise, it should be understood that the circumference and diameter of the tape wrapped around the spool decreases as the length of deployed tape increases” (paragraph 0041 of Tecu). From this teaching, Tecu is disclosing that the payout of the tape from the spool is determined based on the rotations of the spool, the circumference of the spool, and the spiral circumference of the tape on the spool (that is, the circumference of the tape on the spool at any given point in the rotation). From these variables and geometric principles, one of ordinary skill in the art would have understood the necessary calculations to determine the payout of the tape by determining the rotations of the spool and the spiral circumference of the tape on the spool (that is, the circumference of the tape on the spool at any given point in the rotation), as suggested by Tecu, so as to achieve the goals set forth in Tecu); and
determining a level of interstitial swelling based on the length (the determination of the circumference of the limb measured; page 14 of Harfouche; Harfouche teaches the use of the circumference of the limb in the treatment of lymphedema (pages 2-3 of Harfouche).
With respect to claims 9-10, Harfouche teaches the use of the circumference of the limb in the treatment of lymphedema (pages 2-3 of Harfouche). Wekell teaches the use of a system 200 that includes a device 10 worn by a patient 230 that is connected (e.g., wirelessly) to a control system 220. The control system 220 may be connected (e.g., wirelessly) to a healthcare system 205, a support network 210, and the like. The healthcare system 205 includes healthcare professionals, physicians, hospitals, pharmacies, and the like. The support network 210 includes the patient’s friends, family, as well as others involved in the patient’s care. The patient 230, support network 210, and/or the healthcare system 205 may provide reference information 215 to the control system 220. The reference information 215 is used to setup or configure the control system 220. By way of a non-limiting example, the reference information 215 may include patient information (e.g., age, height, weight), patient diagnosis, message routing information, and trigger values. The reference information 215 may also include instructions (e.g., patient instructions) associated with the trigger values. Such instructions may include a predetermined prescribed treatment plan (e.g., instructions to increase a dosage of a diuretic or other medication), instructions to perform a stress test, requests for patient symptom information, instructions to contact healthcare professional, and the like. The reference information 215 may have been provided to a website 217 generated by an optional web server 318 and forwarded to the control system 220 by the web server 318 (paragraph 0037 of Wekell).
Also, Wekell teaches that the healthcare provider or system 205 may access the control system 220 to review the circumference measurement(s) to detect potential problems and/or recommend treatments or changes in treatment. Further, when the control system detects a trend or sudden change in the circumference of the limb 11, the control system 220 may send messages to the healthcare system 205, the support network 210, the patient 230, and the like. When triggered by trigger values, messages sent to the healthcare system 205, the support network 210, the patient 230, and the like may include one or more instructions associated with the trigger values (paragraph 0041 of Wekell).
Further, Wekell teaches that increased peripheral edema measurements might trigger a predetermined prescribed treatment plan that could include increasing a dosage of a diuretic or other medication (paragraph 0179 of Wekell).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine a change in the circumference of the strap on the wrapped spool beyond a preset length threshold; and in response to determining the change in the circumference beyond the preset length threshold, trigger at least one of the one or more processors to enter a predefined state, as suggested by Wekell, so as to intervene when an undesired condition develops.
With respect to claim 10, the combination teaches that the predefined state is a wake mode (the intervention treatment of Wekell is a wake mode).
With respect to claim 16, the combination teaches or suggests one or more non-transitory computer-readable media (the memory of Wekell; paragraph 0207 of Wekell) containing executable instructions that, if executed by one or more processors, cause the one or more processors to perform operations to determine an increase or decrease of interstitial volume in a subject via one or more magnetic sensors in a winder cassette that includes a frame; a capture feature supported by the frame, the capture feature including a magnet; a spring supported by the capture feature; and a spool supported by the frame and surrounding the spring, the spool supporting the magnet; and a measurement assembly that includes an electronics subassembly, wherein the electronics subassembly includes measurement components including a magnetic sensor arranged to be magnetically couplable to the magnet; the one or more processors; and memory (the winder cassette and the measurement assembly is not recited as part of the claimed media), the operations comprising:
determining a first measurement of a first magnetic coupling between the first magnet and the first magnetic sensor (the first measurement between the rotational sensor and one of the magnets on the spool; paragraphs 0023 and 0038 of Tecu);
determining a first angle of the strap-wrapped spool based on the first measurement (the zero-reference sensor of Tecu at the first measurement is used to provide the zero-reference point for the measuring tape so as to ensure the zero angle of the spool is established; paragraphs 0040-0041 of Tecu);
determining the number of rotations of the spool (the determination of the number of time the reel has spun; paragraphs 0023 and 0038 of Tecu);
determining a length of strap unwrapped from the spool based on the first angle and number of rotations of the spool (the determination on the amount of tape that has been deployed; paragraphs 0023 and 0038 of Tecu); and
determining a first circumference representing the volume of interstitial fluid in the subject based on the length of strap unwrapped from the spool (the determination of the circumference of the limb measured; page 14 of Harfouche).
With respect to claims 15 and 20, Harfouche teaches the use of the circumference of the limb in the treatment of lymphedema (pages 2-3 of Harfouche). Wekell teaches the use of a system 200 that includes a device 10 worn by a patient 230 that is connected (e.g., wirelessly) to a control system 220. The control system 220 may be connected (e.g., wirelessly) to a healthcare system 205, a support network 210, and the like. The healthcare system 205 includes healthcare professionals, physicians, hospitals, pharmacies, and the like. The support network 210 includes the patient’s friends, family, as well as others involved in the patient’s care. The patient 230, support network 210, and/or the healthcare system 205 may provide reference information 215 to the control system 220. The reference information 215 is used to setup or configure the control system 220. By way of a non-limiting example, the reference information 215 may include patient information (e.g., age, height, weight), patient diagnosis, message routing information, and trigger values. The reference information 215 may also include instructions (e.g., patient instructions) associated with the trigger values. Such instructions may include a predetermined prescribed treatment plan (e.g., instructions to increase a dosage of a diuretic or other medication), instructions to perform a stress test, requests for patient symptom information, instructions to contact healthcare professional, and the like. The reference information 215 may have been provided to a website 217 generated by an optional web server 318 and forwarded to the control system 220 by the web server 318 (paragraph 0037 of Wekell).
Also, Wekell teaches that the healthcare provider or system 205 may access the control system 220 to review the circumference measurement(s) to detect potential problems and/or recommend treatments or changes in treatment. Further, when the control system detects a trend or sudden change in the circumference of the limb 11, the control system 220 may send messages to the healthcare system 205, the support network 210, the patient 230, and the like. When triggered by trigger values, messages sent to the healthcare system 205, the support network 210, the patient 230, and the like may include one or more instructions associated with the trigger values (paragraph 0041 of Wekell).
Further, Wekell teaches that increased peripheral edema measurements might trigger a predetermined prescribed treatment plan that could include increasing a dosage of a diuretic or other medication (paragraph 0179 of Wekell).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the step of integrating the determining of the level of interstitial swelling with automatic real-time control of treatment of the patient, as suggested by Wekell, so as to intervene when an undesired condition develops.
Allowable Subject Matter
Claims 2-6, 11-14, and 17-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
With respect to claim 2, the prior art does not teach or suggest “at least one interrupt circuit that includes a magnetic sensor and generates interrupts to one of the one or more processors, wherein in response to the rate of interrupts exceeding a preset threshold, the one of the one or more processors enters a predefined state” along with the other features of claim 2.
Claims 3-4 are allowable by virtue of their dependence from claim 2.
With respect to claim 5, the prior art does not teach or suggest “wherein in response to detecting an interrupt associated with a full rotation of the spool, the number of rotations is confirmed using the angle of the spool determined from the angular position” along with the other features of claim 5.
With respect to claim 6, the prior art does not teach or suggest “wherein the operations further comprise: determining a polarity of a second magnetic coupling between the second magnet and the second magnetic sensor; and determining a maximum extension of the strap based on the polarity” along with the other features of claim 6.
With respect to claim 11, the prior art does not teach or suggest “determining a rate of interrupts to one of the one or more processors; and in response the rate of interrupts exceeding a preset threshold, triggering the one of the one or more processors to enter a predefined state” along with the other features of claim 11.
Claim 12 is allowable by virtue of its dependence from claim 11.
With respect to claim 13, the prior art does not teach or suggest “determining a change in the circumference of the strap on the wrapped spool beyond a preset acceleration threshold; and in response to determining the change in the circumference beyond the preset acceleration threshold, triggering the one of the one or more processors to enter a predefined state” along with the other features of claim 13.
Claim 14 is allowable by virtue of its dependence from claim 13.
With respect to claim 17, the prior art does not teach or suggest “at least one interrupt circuit that includes a magnetic sensor and generates interrupts to one of the one or more processors, the operations further comprising: determining a rate of the interrupts; and in response to the rate of interrupts exceeding a preset threshold, triggering the one of the one or more processors to enter a predefined state” along with the other features of claim 17.
Claims 18-19 are allowable by virtue of their dependence from claim 17.
Conclusion
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791