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 following section is in reference to the Applicant’s Amendments, filed May 26, 2026.
The Applicant’s amendments to Claims 1 and 5 have been acknowledged.
The Applicant’s additions of Claims 10 and 11 have been acknowledged.
Claim Objections
Claims 10 and 11 are objected to because of the following informalities:
Claim 10: “wherein the at least one contact element (2) consists of the Phase Change Material (PCM)” should read “wherein the at least one contact element (2) consists of the --PCM--”
Claim 11: “The apparatus (1) according to claim 1, PCM melts or evaporates at body temperature of a person” should read “The apparatus (1) according to claim 1, --wherein the-- PCM melts or evaporates at body temperature of a person”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 recites the limitation: PCM melts or evaporates at body temperature of a person. The Specification is devoid of any description of a PCM that melts or evaporates at body temperature of a person with all the claimed features in Claim 1. Likewise, the drawings also fail to show this structure in accordance with Claim 11 and the corresponding independent Claim 1.
The Applicant cites DE 102014011373 A1 as an example of a PCM, specifically that “In this case, the phase change material has the property that it melts or evaporates at body temperature of a person” (Page 1, lines 19-27). However, this description of the PCM is not directed to the present invention, but instead is used to describe the prior art. The original disclosure fails to provide any working examples or a clear definition of the present apparatus with said features.
In order to show possession at the time of filing, it is imperative for the applicant to show sufficient details of a PCM which is consistent with the structural components and features recited in Claim 1. In the art of phase-change materials, there is significant variability in design and structural choices. In view of the present invention being non-conventional in the art, to show possession at the time of filing, it is imperative for applicant to show sufficient details of a PCM that is dependent on the body temperature of a person, and is consistent with the structural components and features recited in Claim 1.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, and 4-6 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richards (US 20140047623 A1)
Regarding Claim 1, Richards discloses: An apparatus for supporting human movements or for protecting against falls (Abstract, An inflatable fall arrest and fall protection safety system generally having one or more inflatable apparatus attached to a belt or other suitable wearable support structure that can be worn by a user), wherein
the apparatus can be arranged on a body of a person (Paragraph 0070, FIG. 1 shows a wearer 100 wearing one embodiment of a personal protection apparatus 102), the apparatus comprising:
contact surfaces with the body and the contact surfaces are formed completely or partially by at least one contact element (Paragraph 0080, FIG. 6 shows a detailed view of the personal protection apparatus 102. The outer containment 112 is inflatable to a substantially fixed volume 134. The inner bladders 114 are inside of the outer containment 112),
the at least one contact element comprises a Phase Change Material (PCM) (Paragraph 0026-0029, In some embodiments, the inflator is one or more of the following: a compressed gas inflator; an inflator comprising a cartridge filled with a plurality of compounds, when mixed, said plurality of compounds generates gas; or a solid-propellant inflator)
and the extent to which the at least one contact element bears on the body can be adjusted (Paragraph 0078, when the personal protection apparatus 102 senses a vertically downward component of acceleration exceeding a predetermined threshold, the personal protection apparatus 102 inflates to an inflated condition),
and wherein the at least one contact element on the side facing the body of the person has a smaller bearing surface in the resting state (Paragraph 0056, FIG. 2 depicts a front view of one embodiment of the personal protection apparatus in the un-inflated condition) than in the movement state (Paragraph 0079, FIG. 5 shows a front view of wearer 100 wearing the personal protection apparatus 102 in an inflated condition).
Regarding Claim 2, Richards discloses all of the limitations of Claim 1. Richard further discloses: wherein the at least one contact element can be adjusted in the extent to which it bears on the body as a function of a resting and a movement state of the person or the apparatus for supporting human movement (Paragraph 0042, said activation mechanism system initiates an inflation sequence activating each said inflator to generate a volume of pressurized gas into each said inner bladder, said eight inner bladders collectively expanding to fill said substantially fixed volume of said toroid-shaped outer containment, thereby inflating said inflatable apparatus to an inflated and either unrolled or unfolded condition)
Regarding Claim 4, Richards discloses all of the limitations of Claim 1. Richard further discloses: wherein the extent to which the at least one contact element bears on the body is regulated by pressurizing (Paragraph 0026-0029, In some embodiments, the inflator is one or more of the following: a compressed gas inflator; an inflator comprising a cartridge filled with a plurality of compounds, when mixed, said plurality of compounds generates gas; or a solid-propellant inflator) the at least one contact element (Paragraph 0042, said activation mechanism system initiates an inflation sequence activating each said inflator to generate a volume of pressurized gas into each said inner bladder, said eight inner bladders collectively expanding to fill said substantially fixed volume of said toroid-shaped outer containment, thereby inflating said inflatable apparatus to an inflated and either unrolled or unfolded condition)
Regarding Claim 5, Richards discloses all of the limitations of Claim 1. Richard further discloses: wherein the extent to which the at least one contact element bears on the body is regulated pneumatically (Paragraph 0026-0029, In some embodiments, the inflator is one or more of the following: a compressed gas inflator; an inflator comprising a cartridge filled with a plurality of compounds, when mixed, said plurality of compounds generates gas; or a solid-propellant inflator), by means of at least one volume-adjustable air chamber (Paragraph 0080, An inflator 116 is connected to the inner bladder 114 configured to inflate the inner bladder 114 with a volume of pressurized gas. An activation mechanism system 118 senses accelerations and in response to a vertically downward component of acceleration exceeding a predetermined threshold for a predetermined period of time, the activation mechanism system 118 via electrical connection 156 activates the inflator 116 to generate a volume of pressurized gas into the inner bladder 114, which expands to the substantially fixed volume 134 of the outer containment 112).
Regarding Claim 6, Richards discloses all of the limitations of Claim 5. Richard further discloses: wherein the at least one contact element is in active connection with the at least one air chamber (Paragraph 0080, activation mechanism system 118 via electrical connection 156 activates the inflator 116 to generate a volume of pressurized gas into the inner bladder 114, which expands to the substantially fixed volume 134 of the outer containment 112).
Regarding Claim 8, Richards discloses all of the limitations of Claim 5. Richard further discloses: wherein a pressurization of the at least one air chamber is performed by at least one further air chamber (Paragraph 0035, an inflator connected to each said inner bladder configured to inflate each said inner bladder with a volume of pressurized gas in under 250 milliseconds),
which is connected to the at least one air chamber (Paragraph 0036, said activation mechanism system initiates an inflation sequence activating each said inflator to generate a volume of pressurized gas into said eight inner bladders, said eight inner bladders expanding to said substantially fixed volume of said toroid-shaped outer containment),
wherein the at least one further air chamber is reduced in volume by a movement of the person when using the apparatus and thus the at least one air chamber is pressurized (Paragraph 0041, In some embodiments, the predetermined threshold is a vertically downward component of acceleration of at least 30 ft/sec.sup.2 for a predetermined period of time of at least 200 milliseconds and said initiated inflation sequence beginning at said threshold with inflation in the area centered about the midpoint, and progressing in pairs of two, symmetrically to the right and left about the midpoint, followed in less than 100 millisecond successions by the next pairs of two inner bladders progressing toward said ends, wherein said inflation sequence is designed to move the wearer's limbs ergonomically forward as the toroid-shaped outer containment progresses to full inflation).
Regarding Claim 9, Richards discloses all of the limitations of Claim 1. Richard further discloses: wherein the at least one contact element is part of a support and/or application device of the apparatus for body parts of the person (Paragraph 0047, The disclosed subject matter relates to an inflatable fall arrest and fall protection safety apparatus that uses an instantly inflated inflatable apparatus, to prevent the worker's upper body and head from passing between pipes or structural elements, thereby preventing injuries in a wide variety of circumstances and settings. How the device is worn, the trigger mechanism, how it deploys and the size and shape of the instant inflatable apparatus vary in different embodiments).
Regarding Claim 10, Richards discloses all of the limitations of Claim 1. Richard further discloses: wherein the at least one contact element consists of the Phase Change Material (PCM) (Paragraph 0026-0029, In some embodiments, the inflator is one or more of the following: a compressed gas inflator; an inflator comprising a cartridge filled with a plurality of compounds, when mixed, said plurality of compounds generates gas; or a solid-propellant inflator).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Richards (US 20140047623 A1) in view of Buckman (US 20050067816 A1)
Regarding Claim 3, Richards discloses all of the limitations of Claim 1. Richard demonstrates the different arrangement of contact elements in resting (Paragraph 0056, FIG. 2 depicts a front view of one embodiment of the personal protection apparatus in the un-inflated condition) and movement states (Paragraph 0079, FIG. 5 shows a front view of wearer 100 wearing the personal protection apparatus 102 in an inflated condition). It would be obvious that Richards teaches the contact element having varying elevation and depressions on the side facing the patient based on the state of the apparatus.
However, if the Applicant is not convinced, Buckman more explicitly disclose
the at least one contact element has elevations and depressions on the side facing the body of the person in the resting state (Paragraphs 0053-0054, FIG. 1A illustrates a pair of deflated APG shorts; FIG. 1B illustrates a cross-sectional view of one of the deflated chambers of the APG shorts)
and has no or fewer elevations and depressions on the side facing the body of the person in the movement state (Paragraph 0055-0056, FIG. 2A illustrates a pair of APG shorts following activation; FIG. 2B illustrates a cross-sectional view of a chamber of the APG shorts following activation).
Both Richards and Buckman disclose body impact protection apparatuses that incorporate inflatable pockets for selectively pressurized gas. It would have been obvious to one skilled in the art before the effective filing date to incorporate the different arrangements of elevation and/or depressions of the contact elements as demonstrated by Buckman with the existing system disclosed by Richards. It provides varying levels of pressure and bearing on a patient along different parts of their body, as needed for adequate protection and/or treatment.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Richards (US 20140047623 A1) in view of Radspieler et al. (US 20130103125 A1, hereinafter “Radspieler”).
Regarding Claim 7, Richards discloses all of the limitations of Claim 5. Richards discloses an apparatus utilizing pressurized air chambers. However, Richards does not explicitly disclose regulation of the air chamber through means of a pump and/or valve control.
Radspieler does disclose: wherein the volume of the at least one air chamber is regulated by means of a pump and a valve control (Paragraph 0062, The arrows 9 indicate the path of the gaseous coolant through the annular gap 3 around the PCM modules 4. The valve 7 is connected, for example, to a pump, to a ventilator and/or to an external cooling unit (not shown) by which the air or the coolant is conveyed, suctioned, pumped and/or cooled through the annular gap 3, and as a result of which the PCM modules emit heat, or as a result of which moisture is taken up from the orthosis).
Both Richards and Radspieler disclose body-worn apparatuses that utilizes PCM elements to apply provide a degree of stabilization to a wearer (Paragraph 0042, Phase change material includes all types of commercially available PCMs that are capable of storing latent heat). It would have been obvious to one skilled in the art before the effective filing date to incorporate the art-recognized teachings of valve control mechanisms for the pneumatic system disclosed by Richards.
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kelley et al. (US 9358138 B2, hereinafter “Kelley”) view of Radspieler (US 20130103125 A1).
Regarding Claim 1, Kelley discloses: An apparatus for supporting human movements or for protecting against falls (Column 1, lines 14-18, The invention is directed to prosthetic and orthotic devices with optimized heat transfer and/or heat absorption capabilities, including but not limited to, polymeric prosthetic liners, prosthetic sockets, prosthetic assemblies including such liners and sockets, and orthotic braces, boots and insoles), wherein
the apparatus can be arranged on a body of a person (Column 3, lines 39-63, Prosthetic liner embodiments of the invention are designed to enclose at least a portion of a residual limb […] Prosthetic socket embodiments of the invention are designed to receive, retain and support a residual limb, such as a liner-covered residual limb […] Suspension sleeve embodiments of the invention are typically worn in conjunction with a prosthetic socket. That is, once an amputee has inserted his/her residual limb into the socket of a prosthesis, a suspension sleeve may be donned to seal the open (proximal) end of the socket), the apparatus comprising:
contact surfaces with the body and the contact surfaces are formed completely or partially by at least one contact element (Column 9, lines 31-43, Exemplary embodiments of a prosthetic liner with enhanced thermal conductivity and/or enhanced heat absorption capabilities are described below, as are exemplary embodiments of a prosthetic suspension sleeve with enhanced thermal conductivity and/or enhanced heat absorption capabilities, and exemplary embodiments of a prosthetic socket with enhanced thermal conductivity. These exemplary embodiments are provided solely for the purpose of illustration, and not limitation),
the at least one contact element comprises a Phase Change Material (PCM) (Column 6, lines 9-13, a phase change material layer of some thickness may be provided, preferably along an area of a liner, prosthetic socket, suspension sleeve or orthotic device that will reside against or near the skin of a residual or intact limb when worn)
and the extent to which the at least one contact element bears on the body can be adjusted (Column 11, lines 47-52, In addition to the embodiment of FIG. 3 wherein the phase change material is provided in a layer, other similar embodiments may have instead, or in addition to, a phase change material dispersed within the polymeric material, a localized area(s) (e.g., pocket(s)) of phase change material, etc.),
Kelley does not explicitly disclose that the at least one contact element on the side facing the body of the person has a smaller bearing surface in the resting state than in the movement state, but does disclose a contact element that changes shape when the apparatus is in an activated state (Column 19, lines 18-27, The passive cooling device(s) 165 are preferably oriented to optimally move heat from a residual limb located in the socket through the socket wall. Heat flow through these high conductivity paths can also be modulated by a device such as a bimetallic actuator (e.g., a Snap Disc thermostat manufactured by Fenwal Controls). Other possible heat flow modulation devices may include, for example, a wax pellet system where an expansive wax pellet is sealed in a small syringe like structure that then changes length when the wax melts and expands).
However, if the Applicant is not convinced, Radspieler does disclose: An apparatus for supporting human movements or for protecting against falls (Paragraph 0057, FIG. 1 shows the example of a leg or arm prosthesis or orthosis with a device for temperature reduction according to the present invention) the apparatus comprising:
contact surfaces with the body and the contact surfaces are formed completely or partially by at least one contact element (Paragaph 0017, The means by which the medium of the heat exchanger can come into contact with the PCMs, and hereinafter also simply called "means", comprise flow structures such as channels, or elevations with different profiles such as grooves, channels, for example including meandering channels, knobs, pyramids, or others)
wherein at least one contact element (Paragraph 0029, They can be provided on the flexible matrix with the PCMs or also separately therefrom, i.e. externally. Thus, these flow structures can also be provided on the inner face of the socket of a prosthesis, on the inner face of a shoe or of another rigid article that is in contact with the body of a living being. The means are configured such that the medium of a heat exchanger is brought by them into heat-transferring contact with the PCMs of the flexible sheet material), on the side facing the body of the person has a smaller bearing surface in the resting state than in the movement state (Paragraph 0067, According to the invention, the PCM modules 4 can likewise be distributed in any desired manner in the annular gap 3. For example, if less cooling is needed at the top and more is needed at the bottom, the density of the PCM modules can vary in any desired manner over the annular gap 3. Finally, the PCM modules can also be arranged to be movable and/or detachable, such that modules can be shifted or additional modules can be added or taken away), (Paragraph 0021, Provision can be made that the carrier of the flexible sheet material itself causes, for example by inherent movement (e.g. shoe, saddle), the movement of the medium through the flow structures for removing the heat of the PCMs)
Radspieler discloses multiple contact elements in the form of flow structures and PCMs. These elements are flexible and moveable, and are capable of changing shape and position based on the movement and body heat of a user. Both Radspieler and Kelley disclose devices that incorporate phase change materials for temperature regulation in prostheses and orthopedic articles. Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Radspieler’s adjustable heat exchanger elements and flow control, so as to better regulate the temperature and shape of the apparatus to improve user comfort.
Regarding Claim 11, Kelley in view of Radspieler discloses all of the limitations of Claim 1. Radspieler further discloses: the PCM (Paragraph 0066, The PCM modules can be present as discrete packs or a charge of paraffin/polymer compound. However, they can also be present in any other desired form, and also as a simple charge in the annular gap closed at the bottom) melts (Paragraph 0022, According to an advantageous embodiment, the flow of the medium is adjusted such that the temperature of the PCMs is kept below or within the melting range of the PCMs) or evaporates at body temperature of a person, (Paragraph 0036, "Regeneration" of the medium is to be understood primarily as meaning that the medium releases the heat taken up from the body via the PCM), (Paragraph 0041, Everything that generates built-up body heat is intended to be covered within the meaning of the invention),
Response to Arguments
The following section is in reference to the Applicant’s Arguments, filed May 26, 2026.
The Applicant’s arguments with respect to the 101 rejections of Claim 1 and subsequent dependent claims have been fully considered and are persuasive. The 101 rejections have been withdrawn.
The Applicant’s argument with respect to the objection of Claim 1 has been fully considered and are persuasive. The objection has been withdrawn in view of the amendments to the claim language.
Applicant's arguments regarding the 102 rejection of Claim 1 have been fully considered but they are not persuasive.
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the PCM as only a thermal storage medium) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The Applicant fails to clearly define PCM in the present disclosure. The Applicant cites DE 102014011373 A1 as a singular example of a PCM that “melts or evaporates at body temperature of a person”, however, this description of the PCM is not directed to the present invention, but instead is used to describe the prior art.
There is no description provided regarding what phases the material is intended to change from, how the change is to occur, or what specific materials are intended to be used in the present invention. The Applicant explicitly does not describe the functionality of the PCM as “only a thermal storage medium” at any point in the Specification. Furthermore, the Applicant states that “one skilled in the art here is a textile engineer,” however, there is no mention of textiles, threads, or fibers anywhere in the disclosure. It can be argued that Richards also implicitly incorporates heat transfer and thermal exchange elements by nature of the phase changes present in the compressed gas or solid-propellant inflators.
Applicant's arguments regarding the 103 rejections of Claim 3 and 7 have been fully considered but they are not persuasive.
Regarding Claim 3, Buckman meets the limitations as described, as it demonstrates the contact elements with different elevations and depressions based on the activation state of the device. The Applicant claims that an equivalent PCM has been claimed, however, as per the previous Office Action, the equivalent structure identified was “body impact protection apparatuses that incorporate inflatable pockets for selectively pressurized gas”.
Regarding Claim 7, the secondary reference modifying Richards is not Buckman, but is instead Radspieler (US 20130103125 A1), thus making the Applicant’s arguments moot. Radspieler does disclose all the limitations regarding the air chamber, pump, and valve control in a device that is composed of a PCM and a heat-exchanger system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Buckley (US 5722482 A) discloses the use of various phase change materials in different articles of clothing to provide metabolic cooling and insulation for a user.
Applicant's amendment necessitated the new grounds of rejection presented in this Office action. 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 MISHAL HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
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/MISHAL HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights