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 .
Response to Amendment
Receipt is acknowledged of applicant's amendment filed on 3/2/26. Claims 1-24 are cancelled. Claim 50 is new. Claims 25-50 are currently pending and an action on the merits is as follows.
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.
Claim(s) 25-30, 32-34 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hede (IDS item 2) in view of R. H. Smith et al. US 3,313,573.
Regarding claim 25, Hede discloses a device comprising:
a winder cassette comprising a clasp portion and a spindle assembly ([FIG5]), wherein:
the clasp portion is configured to be attached to the spindle assembly and to a first strap end ([FIG5] clasp 12 and strap end 14), and comprises a first latch feature configured to be latched to the spindle assembly ([FIG5] portion 12a); and
the spindle assembly (see annotated figure) comprises:
a second latch feature configured to be latched to the first latch feature of the clasp portion ([¶22] latch 18, which is part of the spindle assembly 10).
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Hede does not specifically disclose the spindle is a hollow spindle or that the spring located at least partially inside the spindle, operably coupled to the spindle, and attached to a second strap end. Smith teaches a similar belt adjustment system that has a hollow spindle ([column 1 lines 69 - column 2 lines 14][FIG2] The spring 25 extends within the spool 23 and secured to the belt end) and a spring that is coupled to the spindle and second strap end ([FIG2]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Hede with the teachings of Smith in order to tighten the belt automatically ([column 4 line 43-53]).
Regarding claim 26, Hede discloses the second latch feature is integrated with the spindle ([FIG4-6] the latch 18 is integral to the spindle assembly).
Regarding claim 27, Hede discloses the device further comprising the strap, wherein the first and second strap ends are first and second ends of the strap ([FIG1] strap 14).
` Regarding claim 28, Hede discloses the first latch feature and the second latch feature are configured to be removably latched together via the first and second latch features to attach and detach the clasp portion and spindle assembly from each other ([FIG22][¶22]).
Regarding claim 29, Hede discloses the first latch feature and second latch feature are configured to be latched together in a manner that enable the clasp portion and the spindle assembly to rotate with respect to the measurement assembly while attached together ([FIG1] the connector can rotate with the strap about a limb).
Regarding claim 30, Hede discloses the clasp portion further comprises two or more vacancies configured for passage of the first end of the strap both in and out of the clasp portion ([FIG3] the clasp portion 12 has two notches in the lower corners that strap passes through, these are considered the vacancies).
Regarding claim 32, Hede discloses the spindle assembly further comprises a capture feature configured to operably couple the spring to the spindle ([FIG5a] catch 24).
Regarding claim 33, Hede discloses the capture feature comprises a bar that extends from an interior wall of the spindle and includes a gap configured for a first end of the spring to pass through the gap and wrap at least part way around the bar to anchor the spring to the spindle ([FIG5a] the spring is wrapped around the spindle and held by catch 24 and the housing).
Regarding claim 34, Hede discloses the capture feature includes first and second pin portions spaced apart by a gap configured for a first end of the spring to pass through the gap and wrap at least part way around at least one of the first and second pin portions to anchor the spring to the spindle ([FIG5a] the spring is wrapped around the spindle and held by catch 24 and the housing. The catch extends from either side with a gap [FIG3]).
Regarding claim 50, Hede discloses a distal end of the strap is threaded through the body of the clasp portion ([FIG3] strap end indicated by 14 is threaded through the clasp 12).
Claim(s) 31 and 35-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hede and R. H. Smith et al. in view of Wekell US 2012/0179067.
Regarding claim 31, Hede does not disclose the clasp portion further comprises one or more cleats configured to be attached to the first strap end. Wekell teaches a similar belt device that uses a cleat for attachment ([¶187] the end 1312 is adhered to itself around 1302 and 1340 can act as a cleat as it adhered to the first end. It is also noted that it would have been obvious to one of ordinary skill in the art at the time of invention to use a physical attachment over adhesive as both are well known and accomplish the same purpose). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Hede with measuring of Wekell in order to monitor peripheral edema ([¶12]).
Regarding claim 35, Hede does not specifically disclose the measurement assembly. Wekell teaches a similar belt device that can make measurements for determining health conditions. Specifically, a measurement assembly wherein the measurement assembly comprises an electronics subassembly and an enclosure, wherein the electronics subassembly includes:
measurement components including one or more optical sensors, one or more processors, memory, 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 ([¶39]):
measuring a circumference of a subject's limb at a repeatable home location over a period of time as an indicator of interstitial fluid volume in the limb ([¶39,199] circumference of the limbs is measured which can indicate edema and interstitial and extracellular fluid);
generating a waveform showing current circumference data derived from the measured circumference over time ([¶40,200] reads are collected over time which is a basic waveform);
comparing the waveform with a waveform of baseline circumference data for the subject at the repeatable home location ([¶40,200] current readings can be compared to historic reads or baseline); and
outputting a result of the comparing with an indication exposed by the comparing ([¶196,200,201] output can be displayed to the patient). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Hede with measuring of Wekell in order to monitor peripheral edema ([¶12]).
Regarding claim 36, Wekell teaches the operations further comprise: detecting limb orientation during the period of time associated with the circumference reading; and modulating the waveform to account for the detected limb orientation according to an algorithm ([¶64,128]).
Regarding claim 37, Hede discloses the spindle assembly rotates to make continuous contact between the strap and at least part of the measurement assembly as the strap extends and retracts ([FIG5]).
Regarding claim 38, Wekell teaches measurement components comprise one or more optical sensors that are positioned to face the strap, emit light to the strap, detect light reflected from the strap, and output a signal corresponding to the amount of the detected light; and wherein the operations further comprise ([¶113]):
comparing the amount of detected light from the output signal with data associating detected light with limb circumference ([¶113] the light is used to determine circumference); and
determining the current circumference at the repeatable home location in accordance with the comparing ([¶114-116]).
Regarding claim 39, Wekell teaches using a gradient with two optical sensors but does not disclose ([113-116]) the two optical sensors are arranged to: detect amplitudes of light reflected from corresponding locations of a first gradient on the strap that gets darker in one direction and a second gradient on the strap that gets lighter in the same direction; and generate a complementary set of data based on the detected amplitudes from the respective optical sensors such that errors related to nonlinearity of the two optical sensors are offset.
However, at the time of filing, it would have been an obvious matter of design choice to a person of ordinary skill in the art to use two gradient in opposite directions because Applicant has not disclosed that such a layout provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the gradient 1545 of Wekell and applicant' s invention, to perform equally well because both gradients would perform the same function of giving a complementary set of readings.
Therefore, it would have been prima facie obvious to modify Wekell to obtain the invention as specified in claim 39 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Wekell.
Regarding claim 40, Wekell teaches the two optical sensors are arranged to: detect amplitudes of light reflected from corresponding locations of a single gradient on the strap that gets darker in one direction; and generate a complementary set of data based on the detected amplitudes from the respective optical sensors such that errors related to nonlinearity of the two optical sensors are offset ([¶113-116]).
Regarding claim 41, Wekell teaches the repeatable home location is at the minimum circumference of the limb ([¶119]).
Regarding claim 42, Wekell teaches the minimum circumference is at one of the wrist or ankle ([¶44]).
Regarding claim 43, Wekell teaches the waveform includes data taken from measurements regardless of clocking orientation of the device about the longitudinal axis of the limb ([¶112] the tensioning member would allow for measurements regardless of clocking orientation).
Regarding claim 44, Wekell teaches the operations further comprise: receiving data related to a swelling state of the limb at the repeatable home location; determining at least one pattern of limb swelling changes over time in the received data; and determining, from the at least one pattern, one or more of stable, transient, or trending changes of swelling associated with a health or disease state ([¶201]).
Regarding claim 45, Wekell teaches the operations further comprise: determining a level of a condition of an impending heart failure decompensation that exceeds a predetermined threshold; and outputting instructions related to the subject's condition ([¶177,201] trigger threshold alert the caregivers).
Regarding claim 46, Wekell does not specifically disclose the operations further comprise: determining changes in viscosity of interstitial fluid in the subject based on the circumference measurements. However, viscosity of the fluid is related to the rate at which the fluid moves from the limb so it would have been obvious to one of ordinary skill in the art at the time of filing to use some basic equation to determine viscosity.
Regarding claim 47, Wekell discloses the indication comprises instructions to be executed on behalf of the subject ([¶172,177,200] alerts and message are relayed to the user).
Regarding claim 48, Wekell discloses the measurement components include a coin battery connected to provide power to one or more of other measurement components of the measurement assembly ([¶62] battery 1620).
Regarding claim 49 Wekell discloses the operations further comprise: calibrating an operating range of at least one of the first gradient or second gradient to account for variability in sensitivity of the optical sensors ([¶73]).
Response to Arguments
Applicant’s arguments, see pgs. 11-14, filed 3/2/26, with respect to the rejection(s) of claim(s) 31 and 35-49 rejected under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hede and Smith.
Regarding Applicant’s argument about the second latch portion, Examiner respectfully disagrees. Hede discloses the second latch portion 18 which is part of the spindle assembly (see annotated figure) and latches with first latch 12 (see FIGs 1-2) which is part of the other half of Hede that is equivalent to the clasp portion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 5712723672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791
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