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 amendments filed 6/22/2026 have been entered. Accordingly, claims 1 and 7-12 are pending in the current application. The amendments have overcome the claim objections previously set forth in the non-final office action dated 3/27/2026.
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.
Claim 1, and thus its dependent claims, 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 1 recites multiple method steps and/or manufacturing steps such as “heat sealed in a manner to create an open rectangular prism”, “folded inward, towards each other, resulting in a V shape”, “wherein the textile sheet being heat sealed at the ends of the textile sheet to render the chamber airtight”, “wherein the soft structure has an ability to have positive curvature, negative curvature, or a mixture thereof upon inflation” - among others. Due to claim 1 being an apparatus claim, and not a method claim, the various recited method steps and/or steps of making do not carry any patentable weight, and therefore the determination of patentability is based on the resulting product itself, and not the method of production. Therefore, the prior art reads on the various stated method steps as long as the prior art is fully capable of performing said steps (see MPEP 2173.05). As the majority of claim 1 recites various method steps and/or manufacturing steps, it is unclear if Applicant is claiming an apparatus of the method of making the apparatus.
Response to Arguments
Applicant's arguments filed 6/22/2026 have been fully considered but they are not persuasive. Regarding claim 1, Applicant argues on pages 7-8 of the remarks that the primary reference of Polygerinos does not teach or suggest the limitations involving a V-shape in an interior of the rectangular prism, with the point of the V directed to the interior of the rectangular prism, in addition to the structural feature that the soft structure has the ability to have a positive curvature, negative curvature, or a mixture thereof upon inflation and depending upon the particular folding and bonding patterns of the structure that are made. With regards to the V-shape interior of the rectangular prism, the Examiner first would like to note claim 1 is a product-by-process claim, and therefore the determination of patentability is based on the resulting product itself, and not the method of production (see MPEP 2173). Therefore, as the method of production in claim 1 details a fabrication method resulting in an air-tight pneumatic chamber, Polygerinos’s device, which utilizes a similar method of fabrication (the fabrication of the inflatable actuators 104 requiring the textile thermoplastic material to be folded towards each other and sealed multiple times to create an I-shaped cross-section, Paragraph 0051 and Figure 7), resulting in an analogous air-tight pneumatic chamber, and therefore reads on the claim. Furthermore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the folded chamber configuration of Polygerinos’s device such that the resulting shape is V-shaped, or any other shape or expedient for a given application, because a change in shape is generally recognized as being within the level of ordinary skill in the art.
With regards to the structural feature that the soft structure has the ability to have a positive curvature, negative curvature, or a mixture thereof upon inflation and depending upon the particular folding and bonding patterns of the structure that are made, as the claim has been amended to recite. The Examiner notes that these particular limitations are directed towards method steps and/or functional language in an apparatus claim, and therefore the prior art reads on the claim as long as the prior art is fully capable of performing said steps/functions (see MPEP 2173.05). As Polygerinos’s device is a soft inflatable structure (soft, inflatable actuators made of heat sealable thermoplastic polyurethane, Paragraph 0010 and Figure 5), with the ability to have adjustable degrees of inflation (Paragraph 0013), the inflatable actuators are fully capable of having the ability to be inflated to a positive or negative curvature, based on the various folding and bonding patterns used in fabrication. Therefore, the Examiner maintains that the prior art reads on the newly added limitations.
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.
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.
Claim(s) 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Polygerinos et al. (US 2019/0029914 A1).
Regarding claim 1, Poylgerinos teaches a transformable pneumatic soft structure (pneumatic inflatable actuators 104, Figures 1 and 5, Paragraph 0040, Abstract; soft, inflatable actuators made of heat sealable thermoplastic polyurethane, Paragraph 0010 and Figure 5) comprising: one or more chambers, each comprised of a single, rectangular, flat textile sheet folded and heat-sealed in a manner to create an open rectangular prism (the fabrication of the inflatable actuators 104 require the textile thermoplastic material to be folded towards each other and heat sealed multiple times to create an I cross-section, Paragraph 0051 and Figure 7), wherein two opposite sides of the rectangular prism are folded inward, towards each other, (the fabrication of the inflatable actuators 104 require the textile thermoplastic material to be folded towards each other and heat sealed multiple times to create an I cross-section, Paragraph 0051 and Figure 7), wherein a thermoplastic coating consists of being on one side of the textile sheet pertaining to the interior of the chamber (inflatable actuators made of heat sealable thermoplastic polyurethane, Paragraph 0010 and Figure 5) wherein the textile sheet being heat sealed at ends of the sheet to render the chamber airtight (see heat seams 116, Figure 7 and Paragraph 0051), forming a 4- layer structure in at least lateral portions of each of a first and second end of the chamber with on the left side of the chamber, in order, a top portion of the textile sheet, an upper portion of the shape, a lower sheet portion of the shape, and a bottom portion of the textile sheet and with on the right side of the chamber, in order, a top portion of the textile sheet, an upper portion of the shape, a lower sheet portion of the shape, and a bottom portion of the textile sheet (once the textile sheet is folded and heat sealed at seams 116, a 4 layer structure is formed in the chamber 104 comprising a top portion, upper portion of the resulting shape, lower portion of the resulting shape, and a bottom portion, Figure 7 and Paragraph 0051); and the upper portion of the shape being sealed to the top portion of the textile sheet in a plurality of locations along the chamber and the bottom portion of the textile sheet being sealed to the bottom portion of the textile sheet in a plurality of locations along the chamber (see heat sealed seams 116 as shown in Figure 7 and described in Paragraph 0051), wherein the soft structure has an ability to have positive curvature, negative curvature, or a mixture thereof upon inflation of the soft structure depending upon particular folding and bonding patterns (the Examiner notes that these particular limitations are directed towards method steps and/or functional language in an apparatus claim, and therefore the prior art reads on the claim as long as the prior art is fully capable of performing said steps/functions (see MPEP 2173.05). As Polygerinos’s device is a soft inflatable structure (soft, inflatable actuators made of heat sealable thermoplastic polyurethane, Paragraph 0010 and Figure 5), with the ability to have adjustable degrees of inflation (Paragraph 0013), the inflatable actuators are fully capable of having the ability to be inflated to a positive or negative curvature, based on the various folding and bonding patterns used in fabrication)), and wherein the soft structure has an open interior space for receiving an appendage of a subject in need thereof (see Figure 8 showing actuators receiving an appendage of a subject in need).
Although Polygerinos teaches a pneumatic chamber formed by folding two sides inwardly towards each other such that an I-shaped cross-section is formed in the chamber (the fabrication of the inflatable actuators 104 require the textile thermoplastic material to be folded towards each other and sealed multiple times to create an I cross-section, Paragraph 0051 and Figure 7), Polygerinos, doesn’t explicitly teach the textile being folded shape being in a resulting in a V shape in an interior of the rectangular prism, with the point of the V directed to the interior of the rectangular prism.
However, it has been held that mere changes in shape do not constitute patentable improvements in the art when said changes do not result in a non-obvious change in functionality (MPEP § 2144.04.IV.B). In this case, the pneumatic chamber of Polygerinos is fabricated in such that way that two sides are folded together, to create an I-shaped cross section, and it is unclear why changing the shape of the resulting folded cross section of the chamber would have fundamentally changed the functionality of the device in an unexpected way. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the folded chamber configuration of Polygerinos’s device such that the resulting shape is V-shaped, or any other shape or expedient for a given application, because a change in shape is generally recognized as being within the level of ordinary skill in the art.
Furthermore, the Examiner notes claim 1 is a product-by-process claim, and therefore the determination of patentability is based on the resulting product itself, and not the method of production (see MPEP 2173). Therefore, as the method of production in claim 1 details a fabrication method resulting in an air-tight pneumatic chamber, Polygerinos’s device, which utilizes a similar method of fabrication (folding a textile sheet, heat-sealing methods), results in an analogous air-tight pneumatic chamber, and therefore reads on the claim.
Regarding claim 7, Polygerinos further teaches a sleeve structure configured to enclose a limb comprising a plurality of the chambers of claim 1 (a soft-inflatable exosuit device includes a plurality of the inflatable actuators 104, Paragraph 0015 and Figure 20), each of the chambers surrounding the limb, the chambers disposed in a determined order along a length of the sleeve structure (see actuators 104 disposed around a user’s leg and along a length of the exo-suit device, Figure 20).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Polygerinos et al. (US 2019/0029914 A1) in view of Roth et al. (US 7,771,376 B2).
Regarding claim 8, Polygerinos teaches the sleeve structure of claim 7, further teaching further comprising: a processor (processor, Paragraph 0014) the processor coupled to control inflation and deflation of the pneumatic chambers (processor configured to control the pressurization of the inflatable actuators 104, Paragraph 0014) with air from at least one air pump (actuators 104 may be pressurized using a pneumatic line connected to a supply source and/or pump, Paragraph 0059); at least one sensor configured to sense a physiological parameter selected from the group consisting of breathing rate, heart rate, and skin conductance (surface electromyographic sensors are used to measure muscle activation, Paragraph 0061; sensors are in communication with each inflatable actuator and thereby control the inflation/deflation of the actuator, Paragraph 0014); and configured to control the inflation and deflation of the chambers according to the sensed physiological parameter (surface electromyographic sensors are used to measure muscle activation, Paragraph 0061; sensors are in communication with each inflatable actuator and thereby control the inflation/deflation of the actuator, Paragraph 0014).
Although Polygerinos teaches a processor configured to control the inflation/deflation of the actuators via sensed signals from various sensors (Paragraph 0014), Polygerinos is silent on a memory containing a haptic program.
However, Roth teaches an inflatable massage garment configured to be secured to a user’s limb (Abstract and Figure 2A) comprising a plurality of inflatable bladders (inflatable bladders 250A-L, Figure 2A) controlled via a processor (microcontroller 323, Col. 9 lines 45-50) comprising a memory containing a haptic program (microcontroller comprises a memory unit comprising specific massage program settings, Col.11 lines 1-10).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Polygerinos’s device such that the processor comprises a memory storing a haptic program, as taught by Roth, as providing a memory of stored programs allows the user to quickly select pre-programmed modes of operation best suited for their individual needs.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Polygerinos et al. (US 2019/0029914 A1) in view of Roth et al. (US 7,771,376 B2) and in further view of Wren et al. (US 2017/0181921 A1).
Regarding claim 9, Polygerinos in view of Roth teach the sleeve structure of claim 8, however are silent on further comprising a digital radio coupled to the processor and configured to link to and communicate with a base station radio.
However, Wren teaches an apparatus comprising a sleeve structure with a plurality of inflatable bladders (Abstract, Figure 4, Paragraph 0113), further comprising a digital radio coupled to the processor (the control device may comprise digital communication means such as digital radio signals, Paragraph 0118), therefore fully capable of communicating with a base station radio.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Polygerinos’s device such that a digital radio is coupled to the processor, as providing digital communication means with the sleeve device allows for external communication and a larger range of control over the device.
Claims 10-12 rejected under 35 U.S.C. 103 as being unpatentable over Polygerinos et al. (US 2019/0029914 A1) in view of Roth et al. (US 7,771,376 B2), Wren et al. (US 2017/0181921 A1) and in further view of Chase et al. (US 2019/0133873 A1).
Regarding claim 10, Polygerinos in view of Roth and Wren teach the sleeve structure of claim 9, with Wren further teaching the digital radio configured to link to and communicate with the base station radio (the control device may comprise digital communication means such as digital radio signals, Paragraph 0118), however are silent on a touchpad, and communication with a second system comprising a second touchpad; the haptic program further configured to control inflation and deflation of the chambers according to input on a second touchpad of the second system, and to transmit commands entered on the second touchpad to the second system.
However, Chase teaches a compression garment comprised of a plurality of controllable inflatable bladders (Abstract, Paragraph 0047 and Figure 1) further teaching digital radio communication (communication interface 59 may be a wireless interface that includes an antenna for sending and receiving various signals such as digital radial signals, Paragraph 0066 and Figure 1) comprising a touchpad (graphical user interface 90 comprising a plurality of push buttons, Paragraph 0061 and Figures 2 and 5), and further teaching a second system comprising a second touchpad (the controller 52 may further include communication with a user interface 99 such as a mobile telephone, therefore comprising a second touch pad, Paragraph 0070 and Figure 1) such that input from the second touchpad transmits commands controlling the inflation and deflation of the plurality of pneumatic chambers (mobile phone 99 may be used by the user to instruct the controller 42 to configure compression therapy as desired, Paragraph 0070).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to further modify Polygerinos’s device such that the system comprises a touchpad, as well as communication with a second system comprising a second touchpad, as taught by Chase, as providing touch pads in communication with the controller is an effective means of allowing the user to easily select the appropriate program settings, and communication with a second system comprising a second touchpad, such as a mobile phone, allows the user to control the device from his/her own personal device.
Regarding claim 11, Polygerinos in view of Roth and Wren teach the sleeve structure of claim 10, with Polygerinos further teaching further comprising: the system comprising at least one sensor configured to sense a physiological parameter selected from the group consisting of breathing rate, heart rate, and skin conductance (surface electromyographic sensors are used to measure muscle activation, Paragraph 0061; sensors are in communication with each inflatable actuator and thereby control the inflation/deflation of the actuator, Paragraph 0014).; the haptic program configured to control the inflation and deflation of the pneumatic chambers according to the sensor configured to sense a physiological parameter of the second system, and to transmit commands entered on the touchpad to the second system (surface electromyographic sensors are used to measure muscle activation, Paragraph 0061; sensors are in communication with each inflatable actuator and thereby control the inflation/deflation of the actuator, Paragraph 0014).
Regarding claim 12, Polygerinos in view of Roth and Wren teach the garment comprising the sleeve structure of claim 11, with Polygerinos further teaching the garment selected from the group consisting of a jacket, sweater, shirt, hat, scarf, gloves, and pants (see actuators 104 disposed around a user’s leg and along a length of the exo-suit device, exo-suit device in the form of pants, Figure 20).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached on (571)-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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