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
This office action is in response to preliminary amendment filed on 02/03/2026. As directed by the amendment, claims 2, 10-12, and 26 were canceled, claims 1 and 25 were amended, and no claims were newly added. Thus, claims 1, 3-9, 13-25, and 27 are presently pending in this application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a processing element” of claim 1 line 2 and claim 25 line 3
The corresponding structure in the specification is [0110] “the processing element 602 may be a microprocessor, microcomputer, graphics processing unit, or the like”.
“a tensioner device” of claim 1 line 10-11
The corresponding structure in the specification is [0084] “The example tensioner device 326 shown includes a shaft 318 and one or more flanges 320”.
“a closure mechanism” of claim 7 line 1
The corresponding structure in the specification is [0012] “the closure mechanism includes at least one of a zipper, a button, a clasp, a hook and loop fastener, or hook and pile fastener”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6, 9, 12-14, 17-18, 20, 23, 25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Moomiaie-Qajar (US8,388,557) in view of Meyer (WO2007/033401A1), and in further view of Johnson ‘592 (US2020/0268592) and Gonon (US 2021/0290477).
Regarding claim 1, Moomiaie-Qajar discloses an apparatus (see Moomiaie-Qajar portable compression device (PCD), col. 6, lines 9 and 10, Figs. 1-3 and 11) for treating venous deficiency (see Moomiaie-Qajar col. 1, line 20) comprising:
a processing element (see Moomiaie-Qajar controller, col. 9, line 42); and
a plurality of actuator assemblies (see Moomiaie-Qajar includes each actuator 16 with corresponding drum 18; three of these actuator/drum arrangements are shown in Fig. 1, col. 10, line 35, Figs. 1-3 and 11) in electrical communication with the processing element (see Moomiaie-Qajar the controller, col. 9, lines 36-45) and positioned along a limb of a user (see Moomiaie-Qajar “LIMB” is fitted into flexible elongate member 20, col. 6, lines 60-63, Examiner’s ANNOTATED Fig. 1a based on Fig. 1 of Moomiaie-Qajar), the plurality of actuator assemblies including a first actuator assembly (see Moomiaie-Qajar top actuator 16/drum 18 assembly as shown in Figs. 1 and 5) and a second actuator assembly (see Moomiaie-Qajar middle actuator 16/drum 18 assembly as shown in Figs. 1 and 5), each including:
a flexible element (see Moomiaie-Qajar elongate member 20 is a composite strap/element (col. 9, lines 2-6) formed of a first material (first material A, Examiner’s ANNOTATED Fig. 1a based from Fig. 1 of Moomiaie-Qajar)) including a body portion (see Moomiaie-Qajar first material A forms a body portion) and two opposing end portions (see Moomiaie-Qajar first material A has two opposing end portions (end C and end D, Examiner’s ANNOTATED Fig. 1a based from Fig. 1 of Moomiaie-Qajar), and ends C and D are respectively attached to the respective end portions (end E and end F of second material B, Examiner’s ANNOTATED Fig. 1a based from Fig. 1 of Moomiaie-Qajar) of the second material (second material B) that passes through drum 18, the first material A in combination with second material B form loop of 20, col. 9, lines 2-5), wherein the body portion (see Moomiaie-Qajar the structure of first material A) is configured to at least partly extend around an outer periphery of the limb (see Moomiaie-Qajar “LIMB”, col. 9, lines 4 and 5);
an actuator (see Moomiaie-Qajar each actuator 16, 116, col. 10, line 35, three 16(s) are shown in Figs. 1 and 11) coupled to the opposing end portions (see Moomiaie-Qajar first material A has two opposing end portions (end C and end D, Examiner’s ANNOTATED Fig. 1a based from Fig. 1 of Moomiaie-Qajar)) and configured to, via a tensioner device (drum 18, 118, ), selectively reduce the distance between the two opposing end portions (see Moomiaie-Qajar the distance that spans between opposing ends C and D of the first material B across the second material B is decreased in length when the second material B is wound up on drum 18 with rotation of drum 18 by actuator 16) to compress the limb (see Moomiaie-Qajar “LIMB”, the mechanical compression is applied to a patient’s limb (see Moomiaie-Qajar “LIMB” when the first material A of 20 is shortened due to the second material B being wound up on drum 18, col. 6, lines 5-15 and col. 10, lines 38-40)), responsive to a signal received from the processing element (see Moomiaie-Qajar the controller(s) for the actuators may be accurately and repeatably apply suitable power/signal to the actuators to achieve the desired strap tension but without overtensioning the strap, col. 9, lines 36 to 67 to col. 10, lines 1 and 2), wherein:
the actuator of the first actuator assembly (see Moomiaie-Qajar each actuator 16, 116) gradually reduces the distance between the two end portions (see Moomiaie-Qajar end C and end D) of the flexible element (see Moomiaie-Qajar 20).
Moomiaie-Qajar discloses a device that includes the processing element, the plurality of actuator assemblies where each actuator assembly includes a flexible element, a tensioning device, an actuator. Moomiaie-Qajar lacks that each actuator assembly further comprises a sensor configured to measure a tautness/compression of the limb. Meyer teaches an apparatus (see Meyer apparatus 150, p. 19, line 13 for preventing deep vein thrombosis (“for enhancing venous blood flow through a limb of person”, p. 19, lines 13 and 14, title, Abstract, Figs. 1-25) that includes a sensor (see Meyer strain gage sensor 152, p. 19, lines 19 and 20, Fig. 11) configured to measure a tension in the flexible element (see Meyer tourniquet 151; pressure sensors for monitoring and controlling the amount of tautness/compression of the tourniquets, p. 19, lines 9-12 and p. 19, lines 24-31 and claim 32). Therefore it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify Moomiaie-Qajar to include a sensor to measure a tautness/compression of the flexible element, as taught by Meyer, to provide improved regulated control over an amount of compression applied to each portion of the limb of a patient via the respective torniquets.
The modified Moomiaie-Qajar teaches the sensor, the actuator of the first actuator assembly gradually reduces the distance between the two end portions of the flexible element. The modified Moomiaie-Qajar lacks that the actuator of the first actuator assembly gradually reduces the distance between two end portions of the flexible element until compression in the limb is greater than or equal to 30mmHg and less than 60 mmHg, as measured by the sensor. Johnson ‘592, however, teaches systems for compression therapy using a compression device including a motor that tightens compression straps (see Johnson Abstract, lines 3-6) on a patient (see Johnson title, Abstract, Figs. 1A-37) that includes sensor(s) (see Johnson stain gauge sensors are used to evaluate compression treatment and is a form of providing a controlled compressive treatment to the patient, ¶ 0123, lines 1-3) in a compression cycle that that can generate compressive forces in a range from 0 mm Hg to greater than 200 mm Hg (see Johnson ¶ middle of ¶ 0123). The amended limitation of “until compression in the limb is greater than or equal to 30 mmHg and less than 60 mm Hg” is not described as critical within Applicants’ specification and is well within the range of 0 mm Hg to greater than 200 mm Hg as taught by Johnson ‘592. Additionally, Johnson ‘592 further provides teaching guidance/characterization regarding effective pressure ranges for the system to compressively apply to the leg of a patient: less than 20 mm Hg as “light compression”; between 20 to 40 mm Hg as “moderate compression”; between 40 and 60 mm Hg as “strong compression”; and greater than 60 mm Hg as “very strong compression” (see Johnson bottom half of ¶ 0112 and/or ¶ 0156; thus, for the claimed range this would be moderate to strong compression applied to the leg of the patient according to Johnson ‘592). Therefore it would be obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the modified Moomiaie-Qajar to have the actuator selectively reduce the distance between two end portions of the flexible element until compression in the limb is greater than or equal to 30 mmHg and less than 60 mmHg, as controlled by the sensor, as taught by Johnson ‘592, to provide/set a compressive range for the limb of the patient that is obvious to try for a doctor/clinician when applying an initial compressive treatment for the patient that can be effective while at the same time also be neither too light of a compressive treatment nor too strong of a compressive treatment for the patient’s limb to accommodate.
Modified Moomiaie-Qajar discloses the actuator of the first actuator assembly gradually increases the distance between the two end portions until compression in the limb is approximately zero, as measured by the sensor (see Meyer sensor 152, modified onto strap 20 of Moomiaie-Qajar. Compression on the limb would read approximately 0 when no compression is applied, i.e. the actuator loosens, see Mooiaie-Qajar leftmost strap 20 configuration in Fig. 6; and Col. 8 lines 14-19 “the actuators can be operably linked to the drum and provide the necessary torque to the drum to… loosen (i.e., at least partially uncoil the strap from a portion of the drum) to a prescribed strap tension”); and the actuator of the second actuator assembly gradually reduces the distance between the two end portions of the flexible element (see Mooiaie-Qajar middle actuator 16/drum 18 of Fig. 1 able to complete the gradual loosening described above regarding compression reading approximately 0).
Modified Mooiaie-Qajar discloses the second actuator reduces the distance at temporally spaced timing from the first actuator (see Moomiaie-Qajar first actuator assembly and second actuator assembly are sequentially activated at different time periods to induce a peristaltic or wave-like compressive force to and along a length of a patient’s limb, col. 7, lines 5-12 of Moomiaie-Qajar), but does not explicitly disclose the actuator of the second actuator assembly gradually reduces the distance at a temporally spaced timing from the first actuator that overlaps with the first actuator to induce a peristaltic wave in the limb.
Even if modified Mooiaie-Qajar does not disclose the limitation, however, Gonon teaches the actuator of the second actuator assembly gradually reduces the distance at a temporally spaced timing from the first actuator that overlaps with the first actuator to induce a peristaltic wave in the limb (see Gonon Fig. 4 chambers C1-C8 depicted as being actuated temporally, such as C2 actuating in the first third of the cycle of C1.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the timing of the first and second actuator sequence actuating of modified Mooiaie-Qajar with the temporally spaced timing inducing a peristaltic wave in the limb through the actuators as taught by Gonon as this would have been an obvious substitution for one known type of temporally spaced timing sequence of the actuators for another and would yield predictable results, i.e. produce a wave-like timing with temporally spaced actuation.
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Examiner’s ANNOTATED Fig. 1a based from Fig. 1 of Moomiaie-Qajar
Regarding claim 3, the modified Moomiaie-Qajar also teaches that the actuator (16, Figs. 1-3 of Moomiaie-Qajar) comprises a rotary actuator (actuator 16 rotates drum 18, and as such actuator 16 is broadly interpreted as a rotary actuator, col. 6, line 67 to col. 7, line 1 of Moomiaie-Qajar).
Regarding claim 4, the modified Moomiaie-Qajar further teaches that the rotary actuator (actuator 16 rotates drum 18, col. 6, line 67 to col. 7, line 1 of Moomiaie-Qajar) comprises a stepper motor (col. 8, lines 12 and 13 of Moomiaie-Qajar).
Regarding claim 6, the modified Moomiaie-Qajar also teaches that the apparatus further comprises a sleeve wearable on the limb of the user, wherein the plurality of actuator assemblies is coupled to the sleeve (“resilient sleeve”, col. 6, lines 24-26, Figs. 1-3 of Moomiaie-Qajar).
Regarding claim 9, the modified Moomiaie-Qajar further teaches that the apparatus and the various elements as recited and rejected in Claim 1 above. The modified Moomiaie-Qajar further teaches that the apparatus (apparatus 150, p. 19, line 13 of Meyer, for preventing deep vein thrombosis (title, Abstract, Figs. 1-25 of Meyer)) further comprises a sensor (strain gage sensor 152, p. 19, lines 19 and 20, Fig. 11 of Meyer) configured to measure a tension in the flexible element (tourniquet 151; pressure sensors for monitoring and controlling the tautness of the tourniquets, p. 19, 24-31 and claim 32 of Meyer). Therefore it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the flexible member of the modified Moomiaie-Qajar to include a sensor to measure a tightness/tension of the flexible element, as taught by Meyer, to provide improved regulated control over an amount of compression applied to the limb of a patient via the torniquet/flexible member.
Regarding claim 12, the modified Moomiaie-Qajar further teaches that the selective reduction of the distance between the two opposing end portions of the flexible element of the first actuator assembly (top assembly that includes 16 and 18, Figs. 1 and 5 of Moomiaie-Qajar) and the selective reduction of distance between the two opposing end portions of the flexible element of the second actuator assembly (middle assembly that includes 16 and 18, Figs. 1 and 5 of Moomiaie-Qajar) at least partially overlap temporally (the second material of each respective strap 20 passes through a respective drum 18 which overlie one another as shown in Fig. 5 of Moomiaie-Qajar so as more of the second material is increasingly taken up on the drum in the successive actuator assemblies at least the selective reduction of the second material of the distance of the first actuator assembly and the selective reduction of the second material of the distance of the second actuator assembly at least partially overlap temporally).
Regarding claim 13, the modified Moomiaie-Qajar further teaches that the sensor (152, Fig. 11 of Meyer) comprises a strain gauge (152, Fig. 13 of Meyer).
Regarding claim 14, the modified Moomiaie-Qajar also teaches that the sensor (152, Fig. 11 of Meyer) is coupled to the flexible element (151, Fig. 11 of Meyer).
Regarding claim 17, the modified Moomiaie-Qajar further teaches that an order of the selective reduction of distance between the two opposing end portions (end C and end D of the first material A, Examiner’s ANNOTATED Fig. 1a based from Fig. 1 of Moomiaie-Qajar) of the flexible element (20) of the first actuator assembly (includes top 16, Fig. 1 of Moomiaie-Qajar) and the selective reduction of distance between the two opposing end portions (end C and end D of the first material A of the flexible element associated with the second actuator assembly) of the flexible element of the second actuator assembly (includes middle 16, Fig. 1 Moomiaie-Qajar) is such that the peristaltic pressure wave is a proximal pressure wave (via controller system that sequentially commands the plurality of actuators to actuate…proximal to distal pressure wave direction, col. 7, lines 1-12 of Moomiaie-Qajar).
Regarding claim 18, the modified Moomiaie-Qajar also teaches that an order of the selective reduction of distance between the two opposing end portions (end C, end D of first material A) of the flexible element (20) of the first actuator assembly (includes top 16, Fig. 1 of Moomiaie-Qajar) and the selective reduction of distance between the two opposing end portions (end C, end D of the first material of the flexible element associated with the second actuator assembly) of the flexible element of the second actuator assembly (includes middle 16, Fig. 1 of Moomiaie-Qajar) is such that the peristaltic pressure wave is a distal pressure wave (distal to proximal pressure wave direction, col. 7, lines 1-12 of Moomiaie-Qajar).
Regarding claim 20, the modified Moomiaie-Qajar further teaches that the sleeve is conformable to the limb (col. 6, lines 24-26 of Moomiaie-Qajar).
Regarding claim 25, Moomiaie-Qajar discloses: a method of treating venous deficiency (portable compression device (PCD), col. 6, lines 9 and 10, Figs. 1-3 and 11) comprising:
applying a wearable device to a limb of a user (“LIMB” is fitted into flexible elongate member 20 or members 20(s), col. 6, lines 60-63, Examiner’s ANNOTATED Fig. 1a based from Fig. 1 of Moomiaie-Qajar and Fig. 1, and col. 6, lines 24-26), wherein the wearable device comprises:
a processing element (controller, col. 9, line 42); and
a plurality of actuator assemblies (each actuator 16 with corresponding drum 18; three of these actuator/drum arrangements are shown in Fig. 1, col. 10, line 35, Figs. 1-3 and 11) in electrical communication with the processing element (the controller, col. 9, lines 36-45) and receivable on the limb (“LIMB”) of the user, the plurality of actuator assemblies including a first actuator assembly (see Moomiaie-Qajar top actuator 16/drum 18 assembly as shown in Figs. 1 and 5) and a second actuator assembly (see Moomiaie-Qajar middle actuator 16/drum 18 assembly as shown in Figs. 1 and 5), each including:
a flexible element (composite flexible elongate member 20 is a composite strap formed of a first material (first material A, Examiner’s ANNOTATED Fig. 1a based from Fig. 1 of Moomiaie-Qajar) that circumscribes/bends around at least a portion of the limb (“LIMB”) of a patient and a second, different material (second material B, Examiner’s ANNOTATED Fig. 1a based from Fig. 1 of Moomiaie-Qajar) that passes through drum 18, col. 9, lines 2-5 and col. 10, lines 37-43; and the specification describes the flexible strap element 304 as a structure, as shown in Fig. 3A of the specification, can bend/fit around a user’s limb which Moomiaie-Qajar’s flexible member/strap 20 does, see ¶ 0081, lines 3 and 4 of the specification) including a body portion (first material A forms a body portion) and two opposing end portions (first material A has two opposing ends/end portions C and D, Examiner’s ANNOTATED Fig. 1a based from Fig. 1 of Moomiaie-Qajar, and ends/end portions C and D are respectively attached to the respective end portions (end portions E and F, Examiner’s ANNOTATED Fig. 1a based from Fig. 1 of Moomiaie-Qajar) of the second material (second material B) that passes through drum 18, the first material A and the second material B form the loop of 20, col. 9, lines 2-5), wherein the body portion (first material A forms a body portion) is configured to at least partly extend around an outer periphery of the limb (“LIMB”);
an actuator (each actuator 16, 116, col. 10, line 35, three 16(s) are shown in Figs. 1 and 11) coupled to the opposing end portions (first material A has two opposing end portions (end C and end D, Examiner’s ANNOTATED Fig. 1a based from Fig. 1 of Moomiaie-Qajar)) and configured to selectively reduce a distance between the two end portions (end C and end D of first material A of the flexible member) to compress the limb (“LIMB”, Examiner’s ANNOTATED Fig. 1a based from Fig. 1 of Moomiaie-Qajar), responsive to a signal received from the processing element (the controller(s) for the actuators may be accurately and repeatably apply suitable power/signal to the actuators to achieve the desired strap tension but without overtensioning the strap, col. 9, lines 36 to 67 to col. 10, lines 1 and 2), wherein the selective reduction of distance of the opposing end portions (end C and end D of first material A) of adjacent actuator assemblies (assemblies that include adjacent 16(s)) of the plurality of actuator assemblies induces a peristaltic pressure wave (col. 6, lines 5-19) in the limb (“LIMB”), the peristaltic pressure wave having a magnitude (col. 6, lines 5-19).
Moomiaie-Qajar discloses a device that includes the processing element, the plurality of actuator assemblies where each actuator assembly includes a flexible element and an actuator and adjacent actuator assemblies of the plurality of actuator assemblies produce a peristaltic pressure wave in the limb, the peristaltic pressure wave having a magnitude. Moomiaie-Qajar lacks that each actuator assembly further comprises a sensor. Meyer teaches an apparatus (apparatus 150, p. 19, line 13 for preventing deep vein thrombosis (“for enhancing venous blood flow through a limb of person”, p. 19, lines 13 and 14, title, Abstract, Figs. 1-25) that includes a sensor (strain gage sensor 152, p. 19, lines 19 and 20, Fig. 11) configured to measure a tension in the flexible element (tourniquet 151; pressure sensors for monitoring and controlling the amount of tautness/compression of the tourniquets, p. 19, lines 9-12 and p. 19, lines 24-31 and claim 32). Therefore it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify Moomiaie-Qajar to include a sensor to measure a tautness/compression of the flexible element, as taught by Meyer, to provide improved regulated control over an amount of compression applied to each portion of the limb of a patient via the respective torniquets.
The modified Moomiaie-Qajar teaches the sensor and the actuator where the actuator selectively reduces the distance between the two end portions of the flexible element. The modified Moomiaie-Qajar lacks that the actuator selectively reduces the distance between two end portions of the flexible element until compression in the limb is greater than or equal to 30mmHg and less than 60 mmHg, as controlled by the sensor. Johnson ‘592, however, teaches systems for compression therapy using a compression device including a motor that tightens compression straps (Abstract, lines 3-6) on a patient (title, Abstract, Figs. 1A-37) that includes sensor(s) (stain gauge sensors are used to evaluate compression treatment and is a form of providing a controlled compressive treatment to the patient, ¶ 0123, lines 1-3) in a compression cycle that that can generate compressive forces in a range from 0 mm Hg to greater than 200 mm Hg (¶ middle of ¶ 0123). The amended limitation of “until compression in the limb is greater than or equal to 30 mmHg and less than 60 mm Hg” is not described as critical within Applicants’ specification and is well within the range of 0 mm Hg to greater than 200 mm Hg as taught by Johnson ‘592. Additionally, Johnson ‘592 further provides teaching guidance/characterization regarding effective pressure ranges for the system to compressively apply to the leg of a patient: less than 20 mm Hg as “light compression”; between 20 to 40 mm Hg as “moderate compression”; between 40 and 60 mm Hg as “strong compression”; and greater than 60 mm Hg as “very strong compression” (bottom half of ¶ 0112 and/or ¶ 0156; thus, for the claimed range this would be moderate to strong compression applied to the leg of the patient according to Johnson ‘592). Therefore it would be obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the modified Moomiaie-Qajar to have the actuator selectively reduce the distance between two end portions of the flexible element until compression in the limb is greater than or equal to 30mmHg and less than 60 mmHg, as controlled by the sensor, as taught by Johnson ‘592, to provide/set a compressive range for the limb of the patient that is obvious to try for a doctor/clinician when applying an initial compressive treatment for the patient that can be effective while at the same time also be neither too light of a compressive treatment nor too strong of a compressive treatment for the patient’s limb to accommodate.
Modified Mooiaie-Qajar discloses controlling the actuator of the first actuator assembly (see Moomiaie-Qajar each actuator 16, 116) gradually reduces the distance between the two end portions (see Moomiaie-Qajar end C and end D) of the flexible element (see Moomiaie-Qajar 20) until compression in the limb is greater than or equal to 30 mmHg and less than 60 mmHg (see Johnson ‘592 range explanation above), as measured by the sensor (see modification to include sensor 151 of Meyer above), then gradually increase the distance between the two end portions until compression in the limb is approximately zero (see Meyer sensor 152, modified onto strap 20 of Moomiaie-Qajar. Compression on the limb would read approximately 0 when no compression is applied, i.e. the actuator loosens, see Mooiaie-Qajar leftmost strap 20 configuration in Fig. 6; and Col. 8 lines 14-19 “the actuators can be operably linked to the drum and provide the necessary torque to the drum to… loosen (i.e., at least partially uncoil the strap from a portion of the drum) to a prescribed strap tension”); and controlling the actuator of the second actuator assembly to gradually reduce the distance between the two end portions of the flexible element (see Mooiaie-Qajar middle actuator 16/drum 18 of Fig. 1 able to complete the gradual loosening described above regarding compression reading approximately 0).
Modified Mooiaie-Qajar discloses controlling the actuator of the second actuator assembly to gradually reduce the distance at temporally spaced timing from the first actuator (see Moomiaie-Qajar first actuator assembly and second actuator assembly are sequentially activated at different time periods to induce a peristaltic or wave-like compressive force to and along a length of a patient’s limb, col. 7, lines 5-12 of Moomiaie-Qajar), but does not explicitly disclose controlling the actuator of the second actuator assembly to gradually reduce the distance between the two end portions of the flexible element at a temporally spaced timing from the first actuator that overlaps with the first actuator to induce a peristaltic wave in the limb.
Even if modified Mooiaie-Qajar does not disclose the limitation, however, Gonon teaches controlling the actuator of the second actuator assembly to gradually reduce the distance at a temporally spaced timing from the first actuator that overlaps with the first actuator to induce a peristaltic wave in the limb (see Gonon Fig. 4 chambers C1-C8 depicted as being actuated temporally, such as C2 actuating in the first third of the cycle of C1. Gonon [0010] describes a similar document where “the inflation sequence begins with a peristaltic wave at cell one and finishes at cell twelve”. This is indicated in Gonon by actuating the chambers C1-C8 as shown in Fig. 4). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the timing of the first and second actuator sequence actuating of modified Mooiaie-Qajar with the temporally spaced timing inducing a peristaltic wave in the limb through the actuators as taught by Gonon as this would have been an obvious substitution for one known type of temporally spaced timing sequence of the actuators for another and would yield predictable results, i.e. produce a wave-like timing with temporally spaced actuation.
Regarding claims 23 and 27, Moomiaie-Qajar in the modified Moomiaie-Qajar inherently teaches that the peristaltic pressure wave has a magnitude, but is silent about this pressure wave having a frequency in a range of about 20 to 60 waves per minute (Claims 23 and 27). Johnson ‘592 teaches systems for compression therapy on a patient (title, Abstract, Figs. 1A-37) that includes a compression of a limb and teaches a single compression and release on the limb about every 1 to 60 seconds. Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the peristaltic pressure wave generated by the modified Moomiaie-Qajar’s device to have a specific pressure wave frequency of about 20 to 60 waves per minute applied to a body part, as taught by Johnson ‘592, to provide a specific frequency for the peristaltic pressure wave that contributes to having an effective compressive therapy treatment for a patient (¶ 0123 of Johnson ‘592).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Moomiaie-Qajar and Meyer, Johnson ‘592, and Gonon as applied to Claim 3 above, and further in view of Kazanchyan (US2016/0331620).
Regarding claim 5, the modified Moomiaie-Qajar discloses a tensioner device and that the actuator is a rotary actuator as described above. The modified Moomiaie-Qajar also discloses that the tensioner device is rotationally coupled to the rotary actuator (col. 6, line 67 to col. 7, lines 1-12 of Moomiaie-Qajar). The modified Moomiaie-Qajar is silent about the opposing end portions (end C, end D, Examiner’s ANNOTATED Fig. 1a based from Fig. 1 of Moomiaie-Qajar) at least partially wrap around the tensioner device to reduce the distance between the two end portions. Kazanchyan teaches a system for enhancing muscle training (Abstract, lines 1-3, Figs. 1-17B) that includes a flexible member (strap 12, ¶ 0076, Fig. 16) having opposing end portions (where 12 attaches to each connector 22 at the right and left portions of Fig. 16) and a tensioning device (outer peripheral surface of motor unit 14, ¶ 0076). The opposing end portions (ends of each strap 12 connected to 22) at least partially wrap around the tensioner device (15) to reduce the distance between the two end portions (¶ 0037, Fig. 16). Therefore it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the modified Moomiaie-Qajar’s flexible member to have the opposing end portions that at least partially wrap around the tensioner device to reduce the distance between the two end portions, as taught by Kazanchyan, to provide additional control for an amount of compressive force to be applied to a limb because the tensioner device can directly tighten the ends of the first material (which directly tightens the first material about the limb of a user) when a substantial portion of the composite flexible member is formed of the first material because the reduced distance between ends C and D of the first material (i.e., because the second material has a smaller length this allows the ends C and D of the first material to more easily be wrapped on to the tensioner device when flexible member 20 is tightened).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Moomiaie-Qajar and Meyer, Johnson ‘592, and Gonon as applied to Claim 6 above, and further in view of Knighton (WO02/02181A).
Regarding claim 7 and 8, the modified Moomiaie-Qajar teaches a sleeve wearable on the limb of a user as described above. The modified Moomiaie-Qajar lacks a closure mechanism coupled to the sleeve and operative to selectively open the sleeve for ease of placement on the limb (Claim 7) and that the closure mechanism is specifically a zipper (Claim 8). Knighton teaches a therapeutic device to provide support to the tissue of a user (Abstract, Figs. 1-7) that includes a closure mechanism coupled to the sleeve and operative to selectively open the sleeve for ease of placement on the limb (p. 15, lines 21-26, Fig. 4) where the closure mechanism is a zipper (p. 15, line 26). Therefore it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the sleeve of modified Moomiaie-Qajar with a closure mechanism coupled to the sleeve and operative to selectively open the sleeve for ease of placement on the limb where the closure mechanism is a zipper, as taught by Knighton, to provide improved ease of positioning and the securing the limb within the sleeve prior to therapeutic treatment.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Moomiaie-Qajar and Meyer, Johnson ‘592, and Gonon as applied to Claim 14 above, and further in view of Guo (KR20160082939A).
Regarding claim 15, the modified Moomiaie-Qajar teaches that the sensor is coupled to the flexible element. The modified Moomiaie-Qajar is silent about the sensor being coupled to the flexible element specifically by stitching. Guo teaches a flexible wearable health care belt (device 100, 1st paragraph under the section “DESCRIPTION OF THE EMBODIMENTS”) that includes a pressure sensor (wireless sensor 138 and its output, Fig. 4) being coupled to the flexible wearable health care belt (100) by stitching (bottom paragraph on p. 13 to top of p. 14). Therefore it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the modified Moomiaie-Qajar to have a stitched connection coupling the sensor and the flexible member/health care belt, as taught by Guo, to provide a known reliable connection that effectively couples together the sensor to the flexible element.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Moomiaie-Qajar and Meyer, Johnson ‘592, and Gonon as applied to Claim 9 above, and further in view of Johnson ‘165.
Regarding claim 16, the modified Moomiaie-Qajar teaches a flexible element and a sensor as described above. The modified Moomiaie-Qajar is silent about the sensor being disposed in the flexible element, that the flexible element comprises a plurality of layers, and that the sensor is disposed between at least two layers of the plurality of layers. Johnson ‘165 teaches a compression device (Abstract, Figs. 1-40) that applies an appropriate amount of compression to an affected limb that includes a flexible member (flexible patch that includes a plurality of layers (¶s 0101-0104, Figs. 25-28)) containing sensors (sensors 1, 2, and 3, Fig. 25) disposed in the flexible member. Additionally, the sensors (sensor 1, sensor 2, sensor 3, top portion of ¶ 0206, Fig. 25) are disposed in the sensor layers of the flexible patch (see Fig. 26) and provide information on the compression therapy (¶ 0206) of a patient. The sensor layers are disposed between at least two layers of the plurality of layers (the outer layer and the inner layer, middle of ¶ 0206, see Fig. 26). Therefore it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the modified Moomiaie-Qajar to have the sensor be disposed in a flexible element where the flexible element comprises a plurality of layers such that the sensor is disposed between at least two layers of the plurality of layers, as taught by Johnson ‘165, to provide a place for the sensors to be positionally located proximate a limb of the user for data measurement and that also affords protection for the sensor elements from being soiled from the environment external to the flexible element as the sensors in the sensor layer are protected by the respective inner and outer layers (¶ 0206, Fig. 26 of Johnson ‘165).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Moomiaie-Qajar and Meyer, Johnson ‘592, and Gonon as applied to Claim 6 above, and further in view of Rousso (WO2006/117771A1).
Regarding claim 19, the modified Moomiaie-Qajar teaches a sleeve formed of first material and a second material as described above, however, is silent about the material of the sleeve specifically being a woven fabric. Rousso teaches a device for enhancement of circulation (title, Abstract, Figs. 1-29) that includes a sleeve that comprises woven fabric (p. 10, lines 21-25). Therefore it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify at least one of the materials of modified Moomiaie-Qajar’s strap to specifically be a woven fabric material, as taught by Rousso, to provide a reliable material for a robust strap construction that is effective to compress a limb of a patient (p. 10, lines 21-30 of Rousso).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Moomiaie-Qajar and Meyer, Johnson ‘592, and Gonon as applied to Claim 6 above, and further in view of Yu (WO2021/196549A1).
Regarding claim 21, the modified Moomiaie-Qajar teaches a sleeve having a circumferential length (see Fig. 6 of Moomiaie-Qajar). The modified Moomiaie-Qajar lacks the specific circumferential length being about 10 cm to about 60 cm. Yu teaches a medical application (Abstract, Figs. 2-5 that contains a flexible member/cuff body (cuff body 100, bottom of p. 5, Fig. 2) made of nylon cloth that can encircle a body part (first paragraph under the “Summary” on p. 2). Yu further teaches that such a member has a length/circumferential length of about 60 cm (3rd full paragraph on p. 8). Therefore it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the strap of Moomiaie-Qajar to have a specific circumferential length of about 60 cm, as taught by Yu, to provide a strap having a sufficient length that is easily fitted around a human body part having predetermined customary sizes (fourth paragraph under the section “Example” on p. 5; typical arm circumferences are between 22 and 45 cm; eight full paragraph on p. 7).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Moomiaie-Qajar and Meyer, Johnson ‘592, and Gonon as applied to Claim 6 above, and further in view of Liang (US2020/0246180).
Regarding claim 22, the modified Moomiaie-Qajar teaches a sleeve having a thickness, but is silent about the sleeve having a thickness of about 5 mm to about 1.5 cm. Liang teaches a compression sleeve (¶s 0004 and 0092, Fig. 13) having a thickness (sleeve 1300, ¶ 0092, Fig. 16) of about 1 mm to 40 mm, or thicker (last portion of ¶ 0092). Therefore it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the strap of the modified Moomiaie-Qajar to have a specific thickness of about 5 mm to about 1.5 cm, as taught by Liang, to provide a sleeve having a sufficient thickness that contributes to having a robust construction of the sleeve that is also effective to compress a body part of a patient.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Moomiaie-Qajar and Meyer, Johnson ‘592, and Gonon as applied to Claim 1 above, and further in view of Wyatt (WO2018/013188A1).
Regarding claim 24, the modified Moomiaie-Qajar teaches a first actuator assembly with a first strap and a second actuator assembly with a second strap to induce a single peristaltic pressure wave in the limb as described above. The modified Moomiaie-Qajar lacks having an induced second peristaltic pressure wave in the limb at the same time and different location as the peristaltic pressure wave. Wyatt teaches a compression device (title, Abstract, first full paragraph on p. 20, Figs. 1-61) including a microcontroller and a plurality of devices (devices 250(s), p. 20, first full paragraph, line 4, Fig. 15) to compress a limb of a user that can be activated and released by the microcontroller to form a single pressure wave up the user’s leg or also generate a series of pressure waves up the user’s leg by the microcontroller alternatingly activating alternate device rows (for example activate device rows 1, 3, and 5, while rows 2, 4 and 6 are idle, p. 20, bottom portion of the first full paragraph on p. 10). Therefore it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the modified Moomiaie-Qajar’s device to have an induced second peristaltic pressure wave in the limb at the same time and different location as the peristaltic pressure wave, as taught by Wyatt, to provide a multiple pressure wave therapy applied to the limb to further enhance the effectiveness of the compressive treatment for a patient (p. 20 of Wyatt, first full paragraph, last three lines).
Response to Arguments
Applicant argues, on pages 7-10 of the remarks, that “None of the cited references teach or suggest a device capably of generating a peristaltic pressure wave, which is significantly different from the sequential, non-overlapping actuations described by the references”. However, Examiner disagrees. Firstly, Moomiaie-Qajar does teach compression of the limb in sequential and/or random patterns (see Moomiaie-Qajar Claim 7 and/or Col. 17 lines 37-39), at least teaching a pattern of actuation in the strap-tightening flexible element apparatus. Applicant argues in the remarks “Gonon, as shown in FIG. 3, uses pneumatic multi-chamber inflatable cuffs-not motorized strap tightening,” referring to teaching reference Gonon. However, Gonon is only relied to teach a pattern of actuation, not the flexible element as is already disclosed in Moomiaie-Qajar. Specifically, as is illustrated in the rejection, the Fig. 4 of Gonon shows temporally spaced actuation of the compression elements, overlapping the actuations. Thus, the pattern is inducing a wave-like compression such as a peristaltic wave compression. Regarding pages 8-10, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore, the rejections still stand.
Conclusion
The prior art made of record and not relied upon is considered pertinent to the applicant' s disclosure.
Wyatt et al. (US 2015/0065930) is cited to show a device for compression with tightening/loosening ribs that are actuated in peristaltic-type compression (Figs 19a-c and [0078]).
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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/GWYNNETH L HOWELL/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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