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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Species A (Figures 1-2 and 7A) and Species c and f (Figures 8C, 9, and 10 drawn to transdermal medication delivery assembly) in the reply filed on 3/4/2026 is acknowledged.
Claims 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention/Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/4/2026.
Claims 1-20 are currently pending, of which claims 1-15 and 20 are currently being examined.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 8-13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grim (RE 34,883).
As per Claim 1, Grim discloses a portable brace assembly configured to be positioned around a user, the user having a back, spine, side, waist, and belly (Abstract, FIG. 1), said assembly comprising: a belt (a body member 202 having belt-like members 216 and 218, FIG. 13, Col. 6, line 59 – Col. 7, line 4) having a support portion (area 214 of body member 202) between a first end portion (belt-like member 216 has a first end potion) and a second end portion (belt-like member 218 has a second end portion), a first side configured to face toward the user (FIG. 13 illustrates a thermal therapy pad 206 that is positioned toward a user, with the inflatable bladder being placed between the belt and the thermal therapy pad 206. See also Col. 7, lines 19-33, discussing that in embodiments lacking a thermal therapy pad 206, that it is important that straps that secure the thermal therapy pad 206 should not be included on the inflatable bladder so that when the belt is worn by a user the straps do not directly engage with the user) and a second side configured to face away from the user (the other side of the belt faces away from the user), wherein the first end portion is releasably connectable the second end portion (mating VELCO® 203 and 225 are placed on each of belt-like members 216 and 218; FIG. 13, Col. 7, lines 1-4) and the first side is radially inward from the second side when the belt is positioned around the user (as noted above, the first side is radially inward from the second side when the belt is positioned from the user); an inflatable bladder (an air bladder assembly 204; FIG. 13, Col. 6, lines 59-64) configured to be attached to the support portion of the belt (the air bladder assembly 204 is attached to a main portion 214 of the main body member 202; FIGs. 13-14, Col. 7, lines 5-18) and to expand from a non-inflated position to an inflated position upon the introduction of fluid (the air bladder assembly expands from a non-inflated position to an inflated position upon the introduction of air, e.g., via a pump 208; FIG. 13, Col. 7, lines 65-68), the inflatable bladder positioned a first distance from the first end portion of the belt (the inflatable bladder is positioned a first distance from a first end portion of a belt, e.g., the first end portion of the belt-like member 216); and a modality (the thermal therapy pad 206) configured to be positioned radially inward from the inflatable bladder (as noted above, the thermal therapy bad is placed toward a user), the modality positioned about the first distance from the first end portion of the belt such that the modality is positioned between the inflatable bladder and the user when the belt is positioned around the user (as noted above, the inflatable bladder is between the user and the thermal therapy pad 206), wherein the inflatable bladder is configured to urge the modality toward the user as the bladder is inflated from the non-inflated position to the inflated position (the thermal therapy pad 206 is positioned against the inflatable bladder and accordingly inflating the inflatable bladder necessarily urges the thermal therapy pad 206 against the user; FIGs. 13-14; Grim discloses means for inflating the air bladder to press the pad 1against the blower back of the user, Col. 4, lines 15-23).
As per Claim 2, Grim discloses the portable brace assembly of claim 1 and further discloses wherein the modality includes one or more of: a medication dispensing assembly, a TENS ("transcutaneous electrical nerve stimulation") unit, a copper pad, a heating pad, a vibration/messaging pad, a cool gel pack, and a magnet (Grim discloses the modality may be a thermal therapy pad 206, which equates to a heating pad; Col. 7, lines. 19-22; Abstract).
As per Claim 3, Grim discloses the portable brace assembly of claim 1 and further discloses further comprising a fastener positioned radially inward from the inflatable bladder for attaching the modality over the inflatable bladder (mating VELCRO pads 224 on the inner surface of the air bladder assembly 204 engage with the VELCRO strips 222 on the thermal therapy pad 206 and the VELCRO strips and pads are positioned radially inward from the air bladder assembly 204 for attaching the thermal therapy pad 206 over the air bladder assembly 204, FIG. 13, Col. 7, lines 19-33).
As per Claim 4, Grim discloses the portable brace assembly of claim 3 and further discloses the fastener is hook and loop fabric (VELCRO strips with mating VELCRO pads equate to a fastener of hook and loop fabric, Col. 7, lines 19-27).
As per Claim 5, Grim discloses the portable brace assembly of claim 1 and further discloses further comprising a pump in fluid communication with the inflatable bladder and configured to introduce fluid into the inflatable bladder to inflate the inflatable bladder (a pump 208 is in communication (e.g., via an inlet 242,244,246) configured to inflate the inflatable bladder 204; FIG. 13 and 15, Col. 9, lines 1-18).
As per Claim 8, Grim discloses the portable brace assembly of claim 1 and further discloses wherein the belt includes a longitudinal center and the inflatable bladder comprise a first bladder member on one side of the longitudinal center and a second bladder member on another side of the longitudinal center (Grim discloses a longitudinal center line as a central plastic bonding line 250. A left-hand bladder 248 is positioned on one side of the bonding line 250 and a right hand bladder 256 is positioned on the other side of the bonding line 250, FIG. 15, Col. 7, line 68 to Col. 8, line 17).
As per Claim 9, Grim discloses the portable brace assembly of claim 1 and further discloses the inflatable bladder comprise a first bladder member and a second bladder member, the first bladder member configured to engage the back on one side of the spine and the second bladder member configured to engage the back on another side of the spine (Grim discloses a first bladder member in the form of a left hand bladder 248 and a second bladder in the form of a right hand bladder 256. FIG. 15 and Col. 8, lines 14-17. Grim discloses that in certain preferred embodiments, a first bladder, such as left hand bladder 248, and a second bladder, such as right hand bladder 256, are positioned on either side of the spine of the user, Col. 2, lines 4-13).
As per Claim 10, Grim discloses the portable brace assembly of claim 1 and further discloses wherein the belt includes a longitudinal center, wherein the support portion is offset with respect to the longitudinal center (see FIGs. 3-5 of Grim illustrating a first section 64, a second section 66, and a third section 68 (also referred to as an intermediate section); Col. 5, lines 8-11. FIG. 5 illustrates that the intermediate portion 68 is offset the longitudinal center of the portable brace assembly).
As per Claim 11, Grim discloses the portable brace assembly of claim 1 and further discloses wherein the support portion is closer to the first end portion than the second end portion (see FIG. 5 of Grim, which illustrates a support portion formed of the intermediate portion or third section 68, wherein the third section 68 is closer to a first end portion defined by the second section 66 and a second end portion defined by the first section 64, Col. 5, lines 4-33).
As per Claim 12, Grim discloses the portable brace assembly of claim 1 and further discloses further comprising a semi-rigid reinforcement member combined with the belt radially outward from the inflatable bladder, said semi-rigid reinforcement member configured to provide a support surface for the inflatable bladder to push against (Grim discloses that the body member 202 may include a composite layer 292 including a central core of foam rubber 294, which equates to a semi-rigid reinforcement member. The body member, and therefore the foam rubber 294, is configured to provide a support surface for the inflatable bladder to push against, as they are designed to inhibit undue bending or buckling of the back support that may occur as a result of inflation of the air bladder assembly 204, Col. 7, lines 34-37; Col. 8, lines 35-46).
As per Claim 13, Grim discloses the portable brace assembly of claim 12 and further discloses wherein the semi-rigid reinforcement member is curved (the portable brace assembly may be curved when worn by a user (see, e.g., FIGs. 1 and 2). Moreover, the semi-rigid reinforcement members are designed to be somewhat flexible and resilient such that it will stretch and bend with moderate forces and accordingly is curved; Col. 8, lines 44-46).
As per Claim 15, Grim discloses the portable brace assembly of claim 1 and further discloses wherein the inflatable bladder is indirectly combined with the first side of the belt and the modality is indirectly combined with the inflatable bladder (the inflatable bladder assembly 204 is indirectly combined with the first side of the belt in that the air bladder may be removably received in a pocket (e.g., pocket 74) but is otherwise indirectly combined with a first side of the belt. Likewise, the pad, equating to the modality is removably received by another pocket (e.g., pocket 72) and accordingly is also indirectly combined with the inflatable bladder, FIGs. 3-4 and Col. 5, lines 18-24).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Grim (RE 34,883) in view of Turner (US 2017/0340472).
As per Claim 6, Grim discloses the portable brace assembly of claim 5 but does not explicitly disclose wherein the pump is configured to communicate with a software application so the pump can be controlled from the software application. Turner discloses a back support device that includes a selectively inflatable and deflatable air bladder (Abstract). Turner discloses a software package, including a mobile software application, that can be used by a patient using the back support device to realign and better their posture or control an electric pump that determines the level of support of the air bladder (Turner at paragraphs [0071]-[0072]). It would have been obvious to one of ordinary skill at the time of the invention to modify the portable brace assembly of Grim to include the software package of Turner, as it would allow for better controlled levels of support of the air bladder and offers suggestions to a user for realigning their posture to better ameliorate back pain problems.
As per Claim 7, Grim discloses the portable brace assembly of claim 5 but does not explicitly disclose wherein the pump is an electric pump. Turner discloses a back support device that includes an electric air pump for selectively inflating and deflating an air bladder (Abstract). It would have been obvious to one of ordinary skill at the time of the invention to modify the portable brace assembly of Grim to include the electric pump of Turner. More specifically, even though Grim discloses a manual pump for selectively inflating and deflating an air bladder, it would be obvious to instead use an electric pump, as some operators may experience difficulty in inflating or deflating a manual pump, and using an electric pump is more convenient.
Claims 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Grim (RE 34,883) in view of Bassuk et al (US 2003/0171710 A1).
As per Claim 14, Grim discloses the portable brace assembly of claim 1 but does not explicitly disclose further comprising a sensor configured to measure data and communicate the data to a processor, wherein the data includes one of bladder pressure, modality information, and information about the length of time the brace assembly is worn by the user for a given period. Bassuk discloses a remote controlled transdermal medication delivery device and is in the field of belt-like apparatuses for delivering medication transdermally to a patient in need thereof (Abstract; FIG. 1). Bassuk discloses a sensor, such as fluid level sensors 98, that monitor modality information (the levels of fluid in a device 20, which equates to a modality, and information relating to the modality, such as the fluid levels of the first, second, and third medications 68, 70, and 72; Paragraph [0045]). It would have been obvious at the time of the invention to modify the portable brace assembly of Grim to include the transdermal medication delivery device of Bassuk to provide a transdermal medication delivery device that is pushed against a patient as a result of inflating the inflatable bladder assembly of Bassuk, thereby helping ensure the medication is effectively transferred to the patient transdermally.
As per Claim 20, Grim discloses the portable brace assembly of claim 1 but does not explicitly disclose wherein the modality is a transdermal medication delivery assembly having a first side, a second side, and a medication reservoir, the first side having a semipermeable membrane, the second side having a fastener configured to selectively attach the transdermal medication delivery assembly to the portable brace assembly. Bassuk discloses a remote controlled transdermal medication delivery device and is in the field of belt-like apparatuses for delivering medication transdermally to a patient in need thereof (Abstract; FIG. 1). Bassuk discloses a device 20 having a first side (a patient facing side 48, FIG. 2, paragraph [0033]), a second side (at FIG. 2 of Bassuk, device 20 is shown as a rectangular box and accordingly has a second side, e.g., the face opposite the patient facing side 48), the first side having a semipermeable membrane (Bassuk discloses a semipermeable medication delivery component 26 that is adapted to be in contact with the skin of the patient such that it is capable of delivering medication through the skin of a patient, abstract; Paragraph [0028]). It would have been obvious to one of ordinary skill at the time of the invention to modify the modality of Grim to include the semipermeable membrane of Bassuk on the patient-facing side of the modality to delivery medication transdermally to a patient in need thereof, where the inflatable bladder of Grim pushes on the modality of Bassuk to ensure the medication is effectively transferred to a patient transdermally.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Daneshvar (US 5,779,657) discloses a similar brace (Figures 7-10) having a belt with a support portion (K, L and 49), an inflatable bladder (5), and a modality (51) positioned radially inward from the inflatable bladder (Figure 9).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kari Rodriquez whose telephone number is 571-270-1909. The examiner can normally be reached Monday-Friday 6-3 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571) 270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786