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
The amendment filed November 18, 2025 has been entered. Claims 1-20 are pending; claims 10-20 are withdrawn from consideration.
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) 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over:
Sullivan et al. (US 20180153418 A1) (hereinafter – Sullivan) in view of
Taniguchi et al. (US 20210307627 A1) (hereinafter – Taniguchi) in further view of
Whalen et al. (US 20170224357 A1) (hereinafter – Whalen).
Re. Claim 1: Sullivan teaches a cuff for measuring blood pressure of a user, comprising:
a cuff configured to wrap at least partially around a limb of the user (Figs. 1A, 1B: adjustable band 104 around limb 106 of a user containing an expandable member);
a measurement bladder configured to restrict blood flow through the limb of the user when measuring blood pressure of the user (Paragraph 0039: “In some further variations, expandable members with a sensor may be characterized as sensing expandable members, and expandable members without a sensor may be characterized as actuating expandable members;” Fig. 3: blood flow restriction required to cease sensed oscillations; Figs. 9A, 9B, 14A, 14B: sensing cell 904 and 1408, i.e., “measurement bladders”);
a pressure sensor configured to measure pressure within the measurement bladder when measuring the blood pressure of the user (Paragraph 0039: “The device 200 further comprises one or more pressure sensors in communication with at least a portion of the expandable member”);
a bladder assembly coupled with the cuff configured to retain a fluid within an internal chamber and maintain a circumferential dimension when a volume of the fluid within the internal chamber is held constant (Paragraph 0037: “The pump 232 may be any of a variety of pumps configured to move and pressurize a liquid or gas… the pump may be configured to pressurize the expandable member and may optionally be configured to also actively deflate the expandable member),
the bladder assembly comprising:
a cell defining at least a portion of the internal chamber (Figs. 7A-18: various configurations of expandable member cells); and
a fluid passage in fluid communication with the cell (Paragraph 0032: “Described herein are exemplary low-profile blood pressure measurement devices, comprising multiple compartments or cells… The band or housing may or may not include one or more of the following components:… an actuator for the expandable structure, such as a fluid pump;” Figs. 15A-17A: each cell possesses a fluid passage); and
a reservoir coupled with the fluid passage and configured to exchange the fluid with the bladder assembly (Paragraph 0037: “In some further variations, the pump may include a fluid reservoir”); and
a valve configured to control the exchange of the fluid between the bladder assembly and the reservoir (Fig. 2B: valve 234).
While Sullivan teaches a valve configured to inflate bladder assembly cells including those configured for measurement (Paragraphs 0042, 0058), Sullivan does not teach that, when measuring the blood pressure of the user, the valve is configured to prevent movement of fluid between the bladder assembly (e.g., non-measurement cells) and the reservoir such that the volume of an internal chamber thereof is held constant and the pump is operated to inflate the measurement bladder.
Taniguchi teaches analogous art in the technology of blood pressure measurement devices having separately inflatable chambers, including chambers of a cuff directed for sensing (Fig. 7). Taniguchi further teaches the invention wherein:
when measuring the blood pressure of the user, the valve is configured to prevent movement of fluid between the bladder assembly and the reservoir such that the volume of the fluid within the chamber is held constant (Fig. 7: either the second on-off valve 16B or third on-off valve 16C, each controlling flow to pressing and tensile cuffs)
and the pump is operated to inflate the measurement bladder (Paragraphs 019-0191: each cuff is inflated, and once predetermined pressure is reached in each of the internal spaces, the corresponding valve is closed).
It would have been obvious to one having skill in the art before the effective filing date to have modified Sullivan as modified by Whalen to include an on-off valve as taught by Taniguchi to control fluid communication of a pump separately between sensing cells and non-sensing cells, the motivation being that such a valve enables each cell to be inflated to a predetermined pressure suitable to allow the sensing cuff to perform pressure measurement (Paragraphs 0190-0191).
While Sullivan as modified by Taniguchi describes a variety of expandable members, and particularly members arranged akin to, e.g., Applicant’s Figs. 4A, 4B (see Sullivan, Figs. 10A, 10B), Sullivan does not describe whether such expandable chambers possess a flattened and thereby elongated configuration such as that of Applicant’s bladder assembly 410b. Thus, Sullivan does not explicitly describe the invention wherein:
the bladder assembly is configured to:
increase in length when a volume of the fluid in the internal chamber decreases;
and decrease in length when the volume of the fluid in the internal chamber increases.
Whalen teaches analogous art in the technology of inflatable limb-worn devices (Abstract). Whalen further teaches the invention wherein:
the bladder assembly is configured to:
increase in length when a volume of the fluid in the internal chamber decreases (Fig. 1D: top figure, each cell having larger deflated width 137);
and decrease in length when the volume of the fluid in the internal chamber increases (Fig. 1D: bottom figure, each cell having smaller inflated width 136, with total length decreased by a shrinkage factor 135 when inflated).
It would have been obvious to one of ordinary skill in the art before effective filing date of the invention to modified the system of Sullivan as modified by Taniguchi to include the tensioning band having flattenable chambers during deflation of such chambers as taught by Whalen, since the claimed invention is merely a combination of old elements (Sullivan as modified by Whalen: teaching adjustment of limb-worn cuff via inflation; Whalen: teaching a similarly inflatable cuff having a differing construction), and in the combination each element merely would have performed the same function as it did separately (adjustment of a circumferential dimension of a limb-worn cuff), and one of ordinary skill in the art would have recognized that the results of the combination were predictable (i.e., producing a limb-worn belt which possesses adjustable tension based on inflation).
Re. Claim 2: Sullivan as modified by Taniguchi and Whalen teaches the invention according to claim 1. Whalen further teaches the invention, wherein:
the cell is a first cell (Fig. 1D: e.g., the cell indicated at 137);
the portion is a first portion (Fig. 1D: e.g., the portion which is defined by the cell indicated at 137);
the cuff further comprises a second cell in fluid communication with the first cell and defining a second portion of the internal chamber (Fig. 1D: chamber connecting tube 124);
the bladder assembly comprises:
a top sheet; and
a bottom sheet joined with the top sheet
(Paragraph 0146: “While the outer belt material 102 and inner belt material 101 are shown to have the inflatable chambers 103 and chamber connecting tubes 124 built into them, the reader shall note that these lines are simply for illustration purposes so it is more clearly what the chamber pattern looks like. In reality, the two materials are flat sheets of fabric as stated above that are connected together via suitable process;” see construction at Fig. 1M);
the first cell is a first elongated tube (Figs. 1C, 1D, as described in Paragraph 0127: “The diameter of a cylinder and the ratio of cylinder length (height 122 in FIG. 1C) to cylinder diameter—known as the cylinder aspect ratio—are two important shape factors that affect the performance of the belt system as described in this application”);
the second cell is a second elongated tube (see previous citation);
the first elongated tube and second elongated tubes are both formed by coupling sections of the top sheet to the bottom sheet (Fig. 1M; see previous citation of Paragraph 0146: particularly, “In reality, the two materials are flat sheets of fabric as stated above that are connected together via suitable process”);
the fluid passage is defined by the top and bottom sheets (Fig. 1M; Paragraph 0126; “When the outer belt material 102 and inner belt material 101 are connected they form a series of interconnected inflatable chambers 103 as shown in FIG. 1A,B”).
Re. Claim 3: Sullivan as modified by Taniguchi and Whalen teaches the invention according to claim 1. Sullivan further teaches the invention wherein
the valve is configured to switch between:
a first state in which the fluid can move between the bladder assembly and the reservoir; and
a second state that prevents the fluid from moving between the bladder assembly and the reservoir
(Paragraph 0038: “In some variations, the valve is normally biased closed but in other variation typically normally biased open. The valve may be an active valve that is mechanically or electrical actuated, such as a solenoid valve or voice coil valve, such that the controller can open or close, or control the resist or flow through the valve, e.g. the bleed rate of the expandable member when detecting blood pressure information, such as the pressure signal or waveform, and/or the onset and cessation of pressure oscillations or Korotkoff sounds, for example… For example, in some variations, a pump may resist air or fluid flow when the pump is in the “off” state, but may permit flow or otherwise generates flow when in the “on” state. Likewise, some pumps, such as certain diaphragm pumps, may be in open in the “off” state to permit flow in one or both directions, but may resist flow in at least one direction when the pump is in the “on” state and generating flow”).
Re. Claim 4: Sullivan as modified by Taniguchi and Whalen teaches the invention according to claim 3. Sullivan further teaches the invention further comprising a housing coupled to the bladder assembly, wherein the reservoir and the valve are located within the housing (Figs. 2A, 2B: components located within device 200; Paragraph 0032: “The band or housing may or may not include one or more of the following components: a visual display, speaker, power source, communication module, and an actuator for the expandable structure, such as a fluid pump”).
Re. Claim 5: Sullivan as modified by Taniguchi and Whalen teaches the invention according to claim 1. Sullivan further teaches the invention wherein the reservoir comprises an elastic member that is configured to increase or maintain a pressure of the fluid as the volume of the fluid in the reservoir increases (Paragraph 0037: “…the pump may comprise a diaphragm pump…;” Examiner notes that a diaphragm pump operates using an elastic member (i.e., a diaphragm) to increase pressure by decreasing a volume in a pump chamber through controlled distension/displacement of the diaphragm).
Re. Claim 6: Sullivan as modified by Taniguchi and Whalen teaches the invention according to claim 1. Whalen further teaches the invention wherein:
the cell is a first cell;
the portion is a first portion;
the cuff further comprises a second cell;
the first cell defines a first elongated tube;
the second cell defines a second elongated tube
(see rejection of claim 2 regarding each of the above limitations); and
the first and second elongated tubes are configured to extend along a length of a limb of the user when the cuff is worn by the user (Figs, 1D-1F; Fig. 1G: limb 90).
Re. Claim 7: Sullivan as modified by Taniguchi and Whalen teaches the invention according to claim 1. Whalen further teaches the invention wherein the bladder assembly comprises:
a top sheet; and
a bottom sheet joined to the top sheet to define the cell, and the fluid passage
(see rejection of claim 2).
Re. Claim 8: Sullivan as modified by Taniguchi and Whalen teaches the invention according to claim 7. Whalen further teaches the invention wherein the bottom sheet is joined to the top sheet at defined locations such that the top sheet and the bottom sheet are substantially inseparable at the defined locations (Paragraph 0124: “The connection between the outer belt material 102 and the inner belt material 101 is preferably heat sealed, or RF welded, or as otherwise described in the prior art…”).
Re. Claim 9: Sullivan as modified by Taniguchi and Whalen teaches the invention according to claim 1. Whalen further teaches the invention wherein:
the cell is a first cell;
the bladder assembly further defines a second cell;
the bladder assembly comprises first and second edges; and
the bladder assembly defines relief features in each of the first and second edges that separate the first and second cells
(Fig. 1B, 1C, 1G, 1H, 1M, 1N: cutout reliefs 132 along edges of cells).
Response to Arguments
Applicant's arguments filed November 18, 2025 have been fully considered but they are not persuasive.
Regarding Applicant’s argument:
The combination of Sullivan, Taniguchi and Whalen does not teach or suggest at least a cuff that includes a pump that is operated to inflate a measurement bladder, and a second independent system of a bladder assembly and a reservoir configured to exchange fluid with the bladder assembly, as recited in claim 1. Sullivan teaches a device having single fluid pump, that may or may not be connected to a reservoir. (Sullivan para. [0037]). Taniguchi also only teaches a device that includes a single fluid pump that can be used to inflate different chambers. (Taniguchi para. [0058]). Whalen also teaches a device with a single "inflation means." (Whalen para. [0132]). None of the devices discuss a device that includes two independent fluid systems that can be operated independently to perform different functions, as included in claim 1 (e.g., the valve is configured to prevent movement of fluid between the bladder assembly and the reservoir such that the volume of the fluid within the chamber is held constant and the pump is operated to inflate the measurement bladder).
Claim 1 does not require two independent fluid systems (i.e., a pump for inflating a measurement bladder to be independent from the system of a reservoir configured to exchange fluid with the bladder assembly). Sullivan teaches a pump connected to a reservoir (Paragraph 0037) which may be used to inflate a measurement bladder (Figs. 9A, 9B, 14A, 14B: “sensing cells”). Such a pump connected to a reservoir is also in communication with a bladder assembly (Figs. 7A-18: expandable member cells), thus providing fluid communication with the reservoir to exchange fluid with the bladder assembly.
Regarding Applicant’s arguments regarding Taniguchi (Remarks, pages 8-9):
Applicant’s arguments appear directed to particulars of Taniguchi not incorporated in the rejection. Taniguchi is utilized solely to teach the use of a valve configured to prevent movement of fluid between the bladder assembly and a reservoir of the pump.
Regarding Applicant’s arguments regarding Whalen (Remarks, 8-9):
Applicant’s arguments appear directed to particulars of Whalen not incorporated in the rejection. Whalen is utilized solely to teach expandable members possessing a flattened and thereby elongated configuration. Applicant’s argument that Whalen teaches away from Taniguchi on the basis that Taniguchi requires a differing structure for applying pressure is unpersuasive. The method by which the two arts apply pressure to a limb does not teach away from their particulars incorporated in the combination (i.e., Taniguchi: incorporating a valve mechanism; Whalen: incorporating chambers which are capable of being flattened). Examiner does not utilize the structure of Taniguchi partially encircling a limb for blood pressure measurement, nor is this a relevant consideration to the valve incorporated.
Additionally, while Applicant argues that Whalen is directed to blood flow restriction training methods which would lead one of ordinary skill in the art away from modifying the occlusion style blood pressure measurement device of Sullivan, the inflation structures of both Sullivan and Whalen share analogous structures (i.e., circular inflatable columnar cells), and both achieve the same function (adjustment of a circumferential dimension of a limb-worn cuff). Examiner, lastly, that since the expandable cells of Sullivan are formed from a flexible material, the expandable member cells may indeed possess the capability of increasing in length when a volume of the fluid of the internal chamber decreases, i.e., when no fluid is present in the cells, which allows the cells to be at least manually flattened. The art of Whalen was presented in order to expedite prosecution.
To expedite prosecution, Examiner recommends claiming the reservoir as being separate from the pump.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791