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 filed 7/30/2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. In particular, there is no reference that matches the description of reference no. 2 under Non-Patent Literature Documents. For example, no reference filed on 7/30/2026 is two pages or is clearly indicated to be a Japanese Office Action mailed on 6/22/2026. This particular reference has not been considered.
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 8 and 15 are objected to because of the following informalities:
in claim 8, line 37: “an increase or decrease” should be “the increase or the decrease”; and
in claim 15, lines 2-3: “the” should be inserted before “interstitial fluid volume”.
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 1-7, 13-14, and 16-20 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 circumference representing the interstitial fluid volume based on the unwrapped length of the strap” in lines 35-37, but it is not clear if this circumference is the same as, related to, or different from “a representation of interstitial fluid volume in a subject” of claim 1, lines 1-2. The claim does not link these two recitations together. The relationship between these two recitations should be made clear. If they are different, it is not clear how the device of claim 1 carries out its intended function of determining a representation of interstitial fluid volume in a subject since no other claim element seems to be used in the determination of “a representation of interstitial fluid volume in a subject”. These ambiguities as to the capability of the device of claim 1 render claim 1 indefinite.
Claims 2-7 are rejected by virtue of their dependence from claim 1.
Claim 2 recites “The device of claim 1, further comprising: at least one interrupt circuit that includes the first magnetic sensor” in lines 1-2, but it is not clear if this interrupt circuit is the same as, related to, or different from “measurement components including a first magnetic sensor ” of claim 1, line 16. The expression “further comprising” in claim 2 connotes that they are different. However, the fact that the first magnet sensor is part of both the interrupt circuit and the measurement components suggests that they are the same or related. The relationship between these two recitations should be made clear.
Claims 3-4 are rejected by virtue of their dependence from claim 2.
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 circumference of the wrapped spool” of claim 8, line 31. 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 16 recites “the device having a winder cassette and a measurement assembly, wherein the winder cassette is configured to receive longitudinal first and second ends of a strap and 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 configured to receive and wrap the strap from the first end thereof around the spool, wherein the spool is supported by the frame, surrounds the spring, and supports the magnet; wherein the measurement assembly includes an electronics subassembly having the one or more processors and measurement components including a magnetic sensor arranged to be magnetically couplable to the magnet” in lines 5-15 13, but it is not clear what meaning these structural features of the device have since the device is not part of the claimed “[o]ne or more non-transitory computer-readable media containing executable instructions”. For example, the structure of the frame and the spring are recited in the claim, but do not bear upon the operations performed by the one or more processor. The status of the particular structure of the device creates confusion as to what the metes and bounds of the claim are. This confusion renders claim 16 indefinite.
Claims 17-20 are rejected by virtue of their dependence from claim 16.
Claim 17 recites “the electronics subassembly further including at least one interrupt circuit that includes the magnetic sensor” in lines 2-3, but it is not clear if how this interrupt circuit relates to the arrangement provided in the recitation “wherein the measurement assembly includes an electronics subassembly having the one or more processors and measurement components including a magnetic sensor” of claim 16, lines 12-15. In claim 16, the magnetic sensor is part of the measurement components. In claim 17, the magnetic sensor is part of an interrupt circuit that is part of the electronics subassembly. This contradiction creates confusion as to what element that the magnetic sensor belongs to. The relationship among these recitations should be made clear.
Claim 17 recites “a rate of the interrupts” in line 6, but it is not clear if this recitation is the same as, related to, or different from “a rate of interrupts” of claim 17, line 5. If they are the same, “a rate of the interrupts” in line 6 should be “the rate of the interrupts”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claims 18-19 are rejected by virtue of their dependence from claim 17.
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 measurement of a first magnetic coupling between the magnet and the magnetic sensor;
[B1] determining, based on the measurement of the magnetic coupling, a number of rotations of the spool around which the strap is wrapped;
[C1] determining, based on the number of rotations of the spool, a wrapped spool diameter equal to a sum of a diameter of the spool itself plus a wrapped thickness of the strap wrapped on the spool;
[D1] determining an unwrapped length of the strap based on the wrapped spool diameter and the number of rotations of the spool;
[E1] determining a circumference representing the interstitial fluid volume in the subject based on the unwrapped length of the strap;
[F1] determining a change in the circumference; and
[G1] determining an increase or decrease of the interstitial fluid volume based on the change in the circumference.
These elements [A1]-[G1] 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 are executable by one or more processors in a device to determine an increase or decrease of interstitial fluid volume in a subject…wherein, if executed by the one or more processors, the instructions cause the one or more processors to perform operations comprising…
[B2] , the device having a winder cassette and a measurement assembly, wherein the winder cassette is configured to receive longitudinal first and second ends of a strap and 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 configured to receive and wrap the strap from the first end thereof around the spool, wherein the spool is supported by the frame, surrounds the spring, and supports the magnet; wherein the measurement assembly includes an electronics subassembly having the one or more processors and measurement components including a magnetic sensor arranged to be magnetically couplable to the magnet,
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, according to one interpretation, 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)).
According to one interpretation, 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)(previously cited), in view of U.S. Patent Application Publication No. 2022/0390220 (Tecu)(previously cited), and further in view of U.S. Patent No. 1,882,385 (Johnson)(previously cited), and further in view of U.S. Patent Application Publication No. 2012/0179067 (Wekell)(previously cited).
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 54 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.
Tecu also 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 (1) determining the rotations of the spool; (2) determining 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) and such a circumference is determined from the wrapped spool diameter (i.e., the sum of the diameter of the spool itself and the wrapped thickness of the tape); and (3) determining the deployed tape which is the spiral circumference of the tape on the spool multiplied by the number of rotations. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine the rotations of the spool; determine the spiral circumference of the tape on the spool from the wrapped spool diameter, and determine the deployed tape from the spiral circumference and the number of rotations since it reduces human error when determining the payout of the spool.
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 a device to determine a representation of interstitial fluid volume in a subject, comprising:
a winder cassette configured to receive longitudinal first and second ends of a strap (the measuring element 3 of Harfouche), wherein the winder cassette 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) configured to receive and wrap the strap from the first end thereof around the spool, wherein the spool is supported by the frame, surrounds the spring, supports a first magnet (the magnets 56 of Tecu) and has 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); a 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 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, based on the measurement of the first magnetic coupling, a number of rotations of the spool around which the strap is wrapped (the determination of the number of time the reel has spun; paragraphs 0023 and 0038 of Tecu);
determining, based on the number of rotations of the spool, a wrapped spool diameter equal to a sum of a diameter of the spool itself plus a wrapped thickness of the strap wrapped on the spool (determining the wrapped spool diameter of Tecu);
determining an unwrapped length of the strap based on the wrapped spool diameter and the 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 circumference representing the interstitial fluid volume based on the unwrapped length of the strap (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.
Tecu also 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 (1) determining the rotations of the spool; (2) determining 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) and such a circumference is determined from the wrapped spool diameter (i.e., the sum of the diameter of the spool itself and the wrapped thickness of the tape); and (3) determining the deployed tape which is the spiral circumference of the tape on the spool multiplied by the number of rotations. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine the rotations of the spool; determine the spiral circumference of the tape on the spool from the wrapped spool diameter, and determine the deployed tape from the spiral circumference and the number of rotations since it reduces human error when determining the payout a spool.
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 fluid volume in a subject, in a device that includes a winder cassette and a measurement assembly, the winder cassette configured to receive longitudinal first and second ends of a strap (the measuring element 3 of Harfouche), wherein the winder cassette has 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) configured to receive and wrap the strap from the first end thereof around the spool, wherein the spool is supported by the frame, surrounds the spring, and supports the magnet; and the measurement assembly having 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; and one or more processors (the control circuit 30 of Tecu), the method 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, based on the measurement of magnetic coupling, a number of degrees of rotation of the spool around which the strap is wrapped (the determination of the number of time the reel has spun; paragraphs 0023 and 0038 of Tecu);
determining, based on the number of degrees of rotation of the spool around which the strap is wrapped, a wrapped spool diameter equal to a sum of a diameter of the spool itself plus a wrapped thickness of the strap wrapped on the spool (determining the wrapped spool diameter of Tecu);
determining a circumference of the wrapped spool based on the wrapped spool diameter (determining the spiral circumference of the tape on the spool from the wrapped spool diameter of Tecu);
determining an unwrapped length of the strap based on the circumference (the determination on the amount of tape that has been deployed; paragraphs 0023 and 0038 of Tecu);
determining a change in the circumference beyond a preset length threshold (the determination of a change in circumference between a limb with lymphedema and a corresponding limb not having lymphedema is beyond 2 cm; pages 2-3 of Harfouche); and
determining an increase or decrease of the interstitial fluid volume in the subject based on the change in the circumference (the determination of an increase in interstitial fluid that warrants treatment; 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 include the operation of, in response to determining the change in the circumference beyond the preset length threshold, triggering 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 are executable by one or more processors in a device to determine an increase or decrease of interstitial fluid volume in a subject, the device having a winder cassette and a measurement assembly, wherein the winder cassette is configured to receive longitudinal first and second ends of a strap and 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 configured to receive and wrap the strap from the first end thereof around the spool, wherein the spool is supported by the frame, surrounds the spring, and supports the magnet; wherein the measurement assembly includes an electronics subassembly having the one or more processors and measurement components including a magnetic sensor arranged to be magnetically couplable to the magnet (the winder cassette and the measurement assembly is not recited as part of the claimed media), wherein, if executed by the one or more processors, the instructions cause the one or more processors to perform operations comprising:
determining a measurement of a first 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, based on the measurement of the magnetic coupling, a number of rotations of the spool around which the strap is wrapped (the determination of the number of time the reel has spun; paragraphs 0023 and 0038 of Tecu);
determining, based on the number of rotations of the spool, a wrapped spool diameter equal to a sum of a diameter of the spool itself plus a wrapped thickness of the strap wrapped on the spool (determining the wrapped spool diameter of Tecu);
determining an unwrapped length of the strap based on the wrapped spool diameter and the 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 circumference representing the interstitial fluid volume in the subject based on the unwrapped length of the strap (the determination of the circumference of the limb measured; page 14 of Harfouche);
determining a change in the circumference (the determination of a change in circumference between a limb with lymphedema and a corresponding limb not having lymphedema is beyond 2 cm; pages 2-3 of Harfouche); and
determining an increase or decrease of the interstitial fluid volume based on the change in the circumference (the determination of an increase in interstitial fluid that warrants treatment; pages 2-3 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 increase or decrease of interstitial fluid volume with automatic real-time control of treatment of the subject, as suggested by Wekell, so as to intervene when an undesired condition develops.
Allowable Subject Matter
Claims 2-6, 13-14, 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 ), second paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 11-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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 the first magnetic sensor and generates interrupts to one of the one or more processors, wherein in response to a rate of the 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 “in response to detecting the interrupt associated with the full rotation of the spool, confirming the number of rotations using an 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 to the rate of interrupts exceeding a preset interrupt 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 an acceleration of the change in the circumference of the strap on the wrapped spool beyond a preset acceleration threshold; and in response to determining the acceleration of 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 the 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 a rate of the 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.
Response to Arguments
The Applicant's arguments filed 7/30/2026 have been fully considered.
Claim objections
In view of the claim amendments filed on 7/30/2026, the previous claim objections have been withdrawn. However, there are new grounds of claim objections that have been necessitated by the claim amendments filed on 7/30/2026.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 7/30/2026, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn. However, there are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that have been necessitated by the claim amendments filed on 7/30/2026.
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph
In view of the claim amendments filed on 7/30/2026, the previous claim rejections under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph, have been withdrawn.
35 U.S.C. 101
There is a new ground of claim rejections under 35 U.S.C. 101 that was necessitated by the claim amendments filed on 7/30/2026.
Also, the Applicant asserts:
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This argument is not persuasive. The steps of determining a change in the circumference and determining an increase or decrease of the interstitial fluid volume based on the change in the circumference are simply additional abstract steps.
Prior art rejections
The Applicant’s arguments with respect to the rejection of claims 1, 7-10, 15-16, and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of claim rejections that were necessitated by the claim amendments filed on 7/30/2026.
Also, the Applicant asserts that paragraphs 0039 and 0041 of Tecu teach that the rotational rotation of Tecu is actually a linear measurement of the circumference of the spool as the spool moves while the claimed invention converts the angular rotation of the spool to a circumference using the diameter. This argument is not persuasive. Tecu teaches two embodiments. The first embodiment of Tecu relies on a linear sensor 52, which appears to be the focus of the Applicant’s arguments. However, the rejection relies on the second embodiment of Tecu that relies on the rotational sensor 54. This second embodiment relies upon angular rotation. Thus, the Applicant’s arguments are not persuasive since they are not commensurate with the rejection.
Claims 8 and 16 are properly rejected for the same reasons as why claim 1 is properly rejected.
The rejection of claims 7, 9-10, 15, and 20 are properly rejected since claims 1, 8, and 16 are properly rejected and the prior art teaches or suggests the features of these claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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