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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/28/26 has been entered.
Response to Amendment
This action is responsive to the amendments filed 1/28/26. As directed, Claims 1,7,10,14-16,18, and 23 have been amended, with no additional claims added or cancelled.
The amendments are sufficient to overcome those claim objections and rejections under 35 USC 112(b) from the previous action which are not recited below.
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 16-20 and 24 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 16 recites “the multiple automatic retention members.” There is insufficient antecedent basis for this limitation in the claim. There are multiple automatic retention apparatuses each having a retention member (which is not described as automatic); it is unclear to which this was intended to refer.
Claim 20 recites “the at least one control circuit includes multiple individual control circuits.” However, since the claims were amended such that each apparatus has a control circuit, it is unclear how these control circuits are intended to be interpreted or relate to one another. It is believed this claim should be deleted in light of the amendments to claim 1.
Claim 24 is inconsistent with the claim 1 limitation reciting at least two apparatuses each include a control circuit. each automatic retention apparatus has a control circuit.
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) 1-3, 11, 14, 20, 22, 23, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ballas et al. [US 2012/0065561 A1, hereinafter “Ballas”] in view of Rovekamp, Jr., et al. [US 2018/0310670 A1, hereinafter “Rovekamp”].
Re. claim 1, Ballas discloses an automatic retention system [100, Fig. 1] for applying pressure to one or more limbs, comprising:
multiple automatic retention apparatuses [102, shown as 102a and 102b in Fig. 1] wherein at least two of the multiple automatic retention apparatuses [2, here] each include:
a retention member configured to surround a portion of at least one limb of the one or more limbs [Fig. 1]; and
an actuator [pump 208, Par. 0050] arranged and configured to engage the retention member [Par. 0048], wherein the actuator is configured to actuate the retention member to adjust pressure applied to the at least one limb by the retention member [“the control unit 212 controls the pump 208 to place the required amount of fluid in the membranes 206 of the bladder system 204. This fluid in the membranes 206 applies radial pressure to the calf of the patient 104 such that the compression device 102 applies the desired compression profile to the calf of the patient,” Par. 0050];
at least one sensor [sensor, Par. 0048, not shown in figs.] arranged and configured to sense changes in a sense parameter associated with the one or more limbs [e.g. a pressure sensor, Par. 0048, which detects the pressure applied to the limb, or an inertial sensor, which senses the ambulatory state of a patient]; and
a control circuit [108 a,b] responsive to the at least one sensor [Par. 0048];
wherein the respective control circuits are in communication with each other, and are configured to collaborate with one another [Par. 0042: “the operation of the multiple compression devices 102 may be coordinated or synchronized. When operating synchronously, the individual control units 108a, 108b and any additional control units associated with additional compression devices may also communicate with one another, which is illustrated in FIG. 1 through the communications link 114”]
to coordinate operation of the actuators based on input received from the sensors of both of the at least two automatic retention apparatuses [Pars. 0042, 0131] to adjust pressure applied to the at least one limb at multiple locations [Par. 0042].
Ballas fails to teach the actuator including a worm gear. However, Rovekamp teaches, in an automatic retention apparatus [Fig. 2],
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the actuator includes a rotatable worm gear [211] with multiple teeth [Par. 0030] engaging one or more recesses [213] extending across the retention member [208], wherein the worm gear is rotatable to adjust tension of the retention member [Par. 0030] and is further operable as a braking mechanism to reduce or eliminate backward rotation to maintain tension on the retention member when the worm gear is at rest [the worm gear inherently does this, as if the gear is not rotating, forward/backward motion is not possible], wherein the actuator is arranged and configured to rotate the worm gear to increase or decrease tension of the retention member in response to input from the control circuit [Par. 0030]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ballas to replace the actuator of Ballas with a rotatable worm gear to increase/decrease tension as taught by Rovekamp because this configuration allows for the actuator to easily adjust tension [Rovekamp Par. 0030], and this amounts to a simple substitution of one type of actuator known in the art for another with predictable results.
Re. claim 2, Ballas discloses a garment [sleeve 216, Fig. 2] configured to surround at least a portion of one of the one or more limbs.
Re. claim 3, Ballas discloses the apparatus set forth above but fails to teach the retention apparatus outside the garment. However, Rovekamp teaches, in an automatic retention system [Figs. 1 and 4; Title, Abstract] for applying pressure to one or more limbs having automatic retention apparatuses, a garment [“article of footwear” 401, Par. 0036, Fig. 4] configured to surround at least a portion of one of the one or more limbs. [Fig. 4] wherein at least one of the multiple automatic retention apparatuses is positioned outside the garment [Fig. 4 shows the retention apparatuses positioned outside the footwear article]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Ballas by configuring at least one of the retention apparatuses to be outside the garment as taught by Rovekamp in order to allow a user to adjust the diameter of the apparatus by hand and to keep the apparatus free of sweat.
Re. claim 11, Ballas discloses the garment includes multiple mounts corresponding to each of the multiple automatic retention apparatuses [Fig. 2 and Par. 0047].
Re. claim 14, Ballas discloses an upper retention apparatus of the at least one automatic retention apparatuses [200a, Fig. 2] is configured to be mounted at an upstream location of a limb of the one or more limbs, and a separate lower retention apparatus [200b] of the at least one automatic retention apparatuses is configured to be mounted at a downstream location of the limb.
Re. claim 20, as best understood, Ballas discloses the at least one control circuit includes multiple individual control circuits [108a and 108b, Fig. 1], and wherein the multiple automatic retention apparatuses are separately responsive to one or more separate control circuits of the multiple individual control circuits [independent operation, Par. 0042].
Re. claim 22, Ballas discloses the at least one sensor includes multiple individual sensors, and wherein multiple individual control circuits are separately responsive to one or more sensors of the multiple individual sensors [Pars. 0042, 0052].
Re. claim 23, Ballas discloses the at least one sensor includes a blood pressure sensor, a temperature sensor configured to determine a temperature of the limb(s), a heart rate sensor, a temperature sensor configured to determine the ambient temperature around the limb, an accelerometer, Inertial Measurement Unit (IMU), or any combination thereof [Par. 0048, 0053].
Re. claim 26, Ballas discloses the apparatus set forth above but fails to teach the cable. However, Rovekamp, teaches a cable [508, Fig. 5] inside a conduit [511], wherein the cable is coupled adjacent a first end to an actuator of at least one of the multiple automatic retention apparatuses [Par. 0043]; a cable actuator responsive to a control circuit that is coupled to the cable adjacent a second end; wherein the cable is selectively movable within the conduit according to movement of the cable actuator, and wherein the actuator is configured to adjust compression applied by the retention member according to movement of the cable relative to the conduit [Fig. 5/ Par. 0043]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ballas by that of Rovekamp to add the cable in the conduit as taught in the embodiment of Fig. 5 because this amounts to a simple substitution of one type of actuator known in the art for another with predictable results.
Claim(s) 7, 12, 16-19, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ballas in view of Rovekamp, as applied to claim 1 or 2 above, and further in view of Dempers et al. [US 2017/0360586 A1, hereinafter “Dempers”].
Re. claim 7, Ballas discloses at least one of the multiple automatic retention apparatuses including a strap [Par. 0049] but fails to teach the material of the strap. However, Dempers teaches, in a retention member mounted to a garment [505, Fig. 5], the retention apparatus includes a cloth strap [fabric, Par. 0087]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ballas by forming the strap of cloth as taught by Dempers because this amounts to a simple substitution of one type of retention member strap material known in the art for another with predictable results.
Re. claim 12, as best understood, Ballas discloses the automatic retention system of claim 1, but fails to teach at least one retention apparatus being mounted remote from the control circuit. However, Dempers teaches at least one of the retention apparatuses being mounted remove from the control circuit [Figs. 1 and 5. Control circuit 140, and straps form the retention apparatuses]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ballas by forming the control circuits to be one control circuit located remote from at least one of the retention apparatuses, as taught by Dempers, in order to allow a single controller to control the different components, reducing the number of parts.
Re. claims 16 (As best understood) and 17, Ballas discloses the automatic retention system of claim 1, but fails to teach the frame. However, Dempers teaches a frame configured to receive at least a portion of a limb, wherein at least one of the multiple retention members is mounted to the frame [Fig. 5], and wherein the frame includes two frame members on opposing sides of the limb [bars 501, Fig. 5], and wherein the two frame members are longitudinally aligned with a reference plane [Fig. 5]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Rovekamp by using the frame which is a brace and forming it to have two frame members as taught by Dempers because such a structure is well known in the art as providing a suitable basis for retaining an apparatus on a limb, providing sufficient structure but also ease of movement.
Re. claim 18, Ballas discloses the automatic retention system of claim 1, but fails to teach the motion as claimed. However, Dempers teaches multiple support elements [710] coupled together and coupled to the frame [Fig. 7], the multiple support elements also aligned with the reference plane [at least part of each strap extends in the reference plane]; wherein the multiple support elements and the frame are coupled together and rotatable substantially parallel to the reference plane [where the plane is through elements 710], and are prevented from rotating away from the reference plane by virtue of multiple projecting members positioned within corresponding cavities of the support elements [724/726; Par. 0055]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ballas by adding the multiple support elements rotating parallel to a reference frame and not in another direction, as taught by Dempers, because this allows the device to be mounted to a hinge joint such as a knee which ensure rotation in the appropriate direction and not in a direction which would harm the user.
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Re. claim 19, Ballas discloses the automatic retention system of claim 1, but fails to teach the frame parts comprising a joint. However, Dempers teaches a frame comprising an upper portion mounted to an upper part of a limb of the one or more limbs; and a lower portion mounted to a lower part of the limb [Annotated Fig. 7]; wherein the upper and lower parts of the limb are coupled together by a joint [724];
wherein at least one upper retention member of a retention apparatus is mounted to the upper portion and surrounds at least a portion of the upper part of the limb; and wherein at least one other retention member of another separate retention apparatus is mounted to the lower portion and surrounds at least a portion of the lower part of the limb [Fig. 7 and Par. 0060]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ballas by configuring the frame to have an upper and lower portion with a joint, wherein at least one upper retention member of a retention apparatus is mounted to the upper portion and surrounds at least a portion of the upper part of the limb; and wherein at least one other retention member of another separate retention apparatus is mounted to the lower portion and surrounds at least a portion of the lower part of the limb as taught by Dempers, because this allows the device to be mounted to a jointed limb such as a leg/knee.
Re. claim 24, as best understood, Ballas discloses the apparatus above but recites multiple control circuits. However, Dempers teaches a single control circuit operatively coupled to the multiple automatic retention apparatuses [Figs. 1 and 5. Control circuit 140, and straps form the retention apparatuses]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ballas by forming the control circuits to be one control circuit, as taught by Dempers, in order to allow a single controller to control the different components, reducing the number of parts.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ballas in view of Rovekamp, as applied to claim 2 above, and further in view of Ben-Noon [US 6010471 A, hereinafter “Ben”]
Re. claim 9, Ballas discloses the garment but fails to teach a portion of one of the retention members being inside the interior passageway. However, Ben teaches a garment with retention members wherein at least a portion of one retention member of the multiple automatic retention apparatuses is positioned inside the interior passageway [pocket 11, Par. 0153]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ballas by adding an interior passageway to the garment and placing at least a portion of one retention member inside the interior passageway as taught by Ben in order to protect the portion of the retention member, while allowing it to be easily removed and replaced so the garment may be washed, for example.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ballas in view of Rovekamp and Ben as applied to claim 9 above, and further in view of Ramanan et al. [US 2020/0237607 A1, hereinafter “Ramanan”].
Re. claim 10, Ballas fails to teach the actuator being external. Ramanan teaches the actuator of the at least one retention member is mounted outside the garment and thus outside any interior passageway [1002, Fig. 1]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ballas in order to allow the overall size/weight of the garment and retention member to be smaller.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ballas in view of Rovekamp, as applied to claim 14 above, and further in view of Ballas, embodiment in Fig. 8.
Re. claim 15, Ballas discloses an upper and lower retention apparatus, but in this embodiment fails to disclose the apparatuses configured to be separated by a joint. However, in Fig. 8, Ballas teaches upper [806a, Fig. 8] and lower [808a] apparatuses separated by a joint [here, the knee]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ballas by configuring the retention apparatuses to be seaparated by a joint as taught by Ballas, embodiment in Fig. 8, in order to apply a desired compression profile to a patient’s leg [Ballas Par. 0064].
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ballas in view of Rovekamp, as applied to claim 26 above, and further in view of Ben.
Re. claim 29, Ballas-Rovekamp fails to teach the cable and conduit inside the interior passageway. However, Ben teaches a garment configured to surround at least a portion of one of the one or more limbs, wherein the garment defines an interior passageway and the cable/conduit are positioned inside the interior passageway [pocket 11, Par. 0153]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ballas-Rovekamp by adding an interior passageway to the garment and placing at least a portion of one retention member inside the interior passageway as taught by Ben in order to protect the portion of the retention member, while allowing it to be easily removed and replaced so the garment may be washed, for example.
Response to Arguments
Applicant's arguments filed 6/13/25 have been fully considered. While the examiner agrees that Ballas fails to teach the worm gear as amended, the examiner finds that Rovekamp, previously cited, teaches this feature.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771