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 Amendments
The Amendment filed 5/4/2026 has been entered. Claims 1-11 and 16-19 were amended. Thus, claims 1-20 are pending in the 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 limitations are: “temperature therapy modules” in claim 1 line 5 and claim 11 line 6, “compressive therapy modules” in claim 1 line 7 and claim 11 line 7, “a heating generation unit” in claim 2 lines 2-3 and claim 12 line 2, “a control unit configured to control” in claim 9 line 2 and claim 19 line 2, and “a footwear item” in claim 10 line 2 and claim 20 line 2.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
According to the Applicant’s specification para. [0010], the limitation of “temperature therapy modules” is being interpreted as a thermoelectric cooler, a heating generator, or equivalents thereof. According to the Applicant’s specification para. [0012], the limitation of “compressive therapy modules” is being interpreted as an inflatable bladder, or equivalents thereof. According to the Applicant’s specification para. [0064], the limitation of “a heating generation unit” is being interpreted as an electrical heating wire, or equivalents thereof. According to the Applicant’s specification para. [0086], the limitation of “a control unit configured to control” is being interpreted as a controller, computing device, mobile computing platform, or equivalents thereof. According to the Applicant’s specification para. [0199], the limitation of “a footwear item” is being interpreted as a piece of cloth to wrap around the foot, hook and loops, shoe laces, or equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid 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, 11-14, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Binversie et al. (US 2015/0182375 A1) in view of Zeutzius et al. (US 2014/0303533 A1).
Regarding claim 1, Binversie discloses a wearable therapy delivery device (therapeutic thermal compression device to be worn on a user) (Fig. 3; abstract; para. [0035]), the wearable therapy device comprising:
an inner layer configured to contact a body surface of a user (inner layer of envelope 32 which contacts the user’s body part surface) (Fig. 3-4, 6; para. [0035]);
an outer layer (outer layer of envelope 32 which is farthest from the user’s body part surface) (Fig. 3-4, 6; para. [0035]);
one or more temperature therapy modules enclosed between the inner layer and the outer layer proximate the inner layer (TEM 312 provides heat or cold to a user; TEM 312 is between the inner and outer layers of the envelope 32) (Fig. 4-6; paras. [0036-0037]; para. [0052]);
one or more compressive therapy modules located proximate the one or more temperature therapy modules (air pump 412, airway tubing 414, and inflatable bladder 410; inflatable bladder 410 is located proximate the TEM 312) (Fig. 4-6, 9A-9B; para. [0036]; para. [0053]; claim 15),
wherein the one or more compressive therapy modules are configured to force the one or more temperature therapy modules toward the body surface of the user (when inflated, as the inflatable bladder 410 is behind the TEM 312, the inflatable bladder 410 would move the TEM 312 closer to the user’s body part surface) (Fig. 3-6; para. [0036]; claim 14),
and a battery pack (device 10 has a battery) (Figs. 1, 10; para. [0057]).
Binversie does not disclose the battery pack operatively attached to an outside surface of the wearable therapy device.
However, Zeutzius teaches an intermittent pneumatic compression system (Zeutzius; abstract) including the battery pack operatively attached to an outside surface of the wearable therapy device (controller module 100 for a portable intermittent pneumatic compression system has a battery compartment under battery cover 115; controller module 100 is attached to an outside surface of a leg wrap 600, 605) (Zeutzius; Figs. 1, 7, 10; para. [0035]; para. [0058]).
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 Binversie device 10 to be mounted on garment 30 to reduce tubing, such that the battery pack is operatively attached to an outside surface of the wearable therapy device, as taught by Zeutzius, for the purpose of improving portability and reducing tripping/fall hazards (Zeutzius; abstract; para. [0004]).
Regarding claim 2, the modified Binversie teaches wherein the temperature therapy module comprises at least one of a thermoelectric cooler (TEC) and a heating generation unit (TEM 312 provides heat or cold to a user) (Binversie; Fig. 4-6; para. [0037]; para. [0052]).
Regarding claim 3, the modified Binversie teaches wherein the temperature therapy module is configured to operate in a range from 100°F to 140°F (controllable temperature range of 10-150 degrees Fahrenheit) (Binversie; para. [0066]).
Regarding claim 4, the modified Binversie teaches wherein the compressive therapy module comprises an inflatable bladder (inflatable bladder 410) (Binversie; Fig. 4-6; para. [0036]).
Regarding claim 6, the modified Binversie teaches further comprising a spacer disposed between the one or more compressive therapy modules and the one or more temperature therapy modules (housing 222 is between the TEM 312 and the inflatable bladder 410) (Binversie; Fig. 4-6; para. [0051]).
Regarding claim 9, the modified Binversie teaches further comprising a control unit configured to control operation of the one or more temperature therapy modules and the one or more compressive therapy modules (control system 100 used to coordinate the operation of the temperature and compression systems) (Binversie; Figs. 1, 10; abstract; para. [0041]; claim 1), wherein the control unit is operatively connected to the battery pack (controller module 100 for a portable intermittent pneumatic compression system has a battery compartment under battery cover 115; the battery supplies the power to operate the system) (Zeutzius; Figs. 1, 7, 10; abstract; para. [0035]).
Regarding claim 11, Binversie discloses a method for delivering a therapy (method for therapeutic thermal compression) (abstract), the method comprising the steps of:
providing a wearable therapy delivery device (therapeutic thermal compression device to be worn on a user) (Fig. 3; abstract; para. [0035]) comprising:
an inner layer configured to contact a body surface of a user (inner layer of envelope 32 which contacts the user’s body part surface) (Fig. 3-4, 6; para. [0035]);
an outer layer (outer layer of envelope 32 which is farthest from the user’s body part surface) (Fig. 3-4, 6; para. [0035]);
one or more temperature therapy modules enclosed between the inner layer and the outer layer proximate the inner layer (TEM 312 provides heat or cold to a user; TEM 312 is between the inner and outer layers of the envelope 32) (Fig. 4-6; paras. [0036-0037]; para. [0052]), and
one or more compressive therapy modules located proximate the one or more temperature therapy modules (air pump 412, airway tubing 414, and inflatable bladder 410; inflatable bladder 410 is located proximate the TEM 312) (Fig. 4-6, 9A-9B; para. [0036]; para. [0053]; claim 15), wherein the one or more compressive therapy modules are configured to force the one or more temperature therapy modules towards the body surface of the user (when inflated, as the inflatable bladder 410 is behind the TEM 312, the inflatable bladder 410 would move the TEM 312 closer to the user’s body part surface) (Fig. 3-6; para. [0036]; claim 14);
applying the inner layer of the wearable therapy delivery device to the body surface (inner layer of envelope 32 contacts the user’s body part surface) (Fig. 3-4, 6; para. [0035]); and
activating the one or more temperature therapy modules and the one or more compressive therapy modules (the TEM 312 is activated for a temperature stimulus and the inflatable bladder 410 is operated for a compression stimulus) (claims 1, 15).
Binversie does not disclose a battery pack operatively attached to an outside surface of the wearable therapy delivery device.
However, Zeutzius teaches an intermittent pneumatic compression system (Zeutzius; abstract) including the battery pack operatively attached to an outside surface of the wearable therapy device (controller module 100 for a portable intermittent pneumatic compression system has a battery compartment under battery cover 115; controller module 100 is attached to an outside surface of a leg wrap 600, 605) (Zeutzius; Figs. 1, 7, 10; para. [0035]; para. [0058]).
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 Binversie device 10 to be mounted on garment 30 to reduce tubing, such that the battery pack is operatively attached to an outside surface of the wearable therapy device, as taught by Zeutzius, for the purpose of improving portability and reducing tripping/fall hazards (Zeutzius; abstract; para. [0004]).
Regarding claim 12, the modified Binversie teaches wherein the temperature therapy module comprises at least one of a thermoelectric cooler (TEC) and a heating generation unit (TEM 312 provides heat or cold to a user) (Binversie; Fig. 4-6; para. [0037]; para. [0052]).
Regarding claim 13, the modified Binversie teaches wherein the temperature therapy module is configured to operate in a range from 100°F to 140°F (controllable temperature range of 10-150 degrees Fahrenheit) (Binversie; para. [0066]).
Regarding claim 14, the modified Binversie teaches wherein the compressive therapy module comprises an inflatable bladder (inflatable bladder 410) (Binversie; Fig. 4-6; para. [0036]).
Regarding claim 16, the modified Binversie teaches wherein the wearable therapy delivery device further comprises a spacer disposed between the one or more compressive therapy modules and the one or more temperature therapy modules (housing 222 is between the TEM 312 and the inflatable bladder 410) (Binversie; Fig. 4-6; para. [0051]).
Regarding claim 19, the modified Binversie teaches wherein the wearable therapy delivery device further comprises a control unit configured to control operation of the one or more temperature therapy modules and the one or more compressive therapy modules (control system 100 used to coordinate the operation of the temperature and compression systems) (Binversie; Figs. 1, 10; abstract; para. [0041]; claim 1), wherein the control unit is operatively connected to the battery pack (controller module 100 for a portable intermittent pneumatic compression system has a battery compartment under battery cover 115; the battery supplies the power to operate the system) (Zeutzius; Figs. 1, 7, 10; abstract; para. [0035]).
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Binversie in view of Zeutzius as applied to claims 1 and 11 above, and further in view of Pickett et al. (US 2006/0004245 A1).
Regarding claims 5 and 15, the modified Binversie teaches the invention as previously claimed, but does not teach wherein the compressive therapy module is configured to operate in a range from 120 psi to 200 psi.
However, Pickett teaches an external counterpulsation apparatus (Pickett; abstract) wherein the compressive therapy module is configured to operate at about 100 psi (air tank 52 with operating pressure of about 100 psi to supply air to a regulator 54 and then bladders 64) (Pickett; Fig. 4; para. [0054]), which is close to the claimed range of 120 psi to 200 psi. According to the MPEP 2144.05(I) and MPEP 2144.05(II)(A), a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, absent any showing of unexpected results or criticality. As the Applicant’s claimed range of 120 psi to 200 psi lacks criticality, one of ordinary skill in the art would be able to use the about 100 psi teaching of Pickett to reach the Applicant’s claimed range through routine experimentation for optimizing the pressure of the bladders and the speed at which they are filled with pressurized air, as a higher air pressure in the air tank would have that pressurized air move more quickly to fill the bladders.
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 Binversie compressive therapy module to include an air tank and regulator such that the compressive therapy module is configured to operate at a range from 120 psi to 200 psi, as taught by Binversie and the MPEP, for the purpose of providing a structure for holding and regulating a sufficient pressure of air with which to distribute to one or more individual bladders (Pickett; para. [0054]).
Claims 7-8 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Binversie in view of Zeutzius as applied to claims 1 and 11 above, and further in view of Katsui (US 6,043,980).
Regarding claims 7 and 17, the modified Binversie teaches the invention as previously claimed, but does not teach wherein the spacer comprises at least one wing disposed about an outer perimeter of the spacer.
However, Binversie does teach using heat sink fins 216 in a housing 222, wherein the housing 222 can include a fan which is not shown (Binversie; Figs. 4-6; para. [0051]). Furthermore, Katsui teaches a heat sink (Katsui; abstract) wherein the spacer comprises at least one wing disposed about an outer perimeter of the spacer (the cover 21 has resilient engaging members 21b around its perimeter) (Katsui; Fig. 9; col. 9, lines 44-53).
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 Binversie spacer to include at least one wing disposed about an outer perimeter of the spacer, as taught by Katsui, for the purpose of providing the spacer with a specific structure with which to hold a fan for cooling a heat sink (Binversie, para. [0051]; Katsui, col. 9 lines 44-53).
Regarding claims 8 and 18, the modified Binversie does not teach wherein the spacer comprises at least five wings disposed about an outer perimeter of the spacer.
However, the modified Binversie does teach the spacer comprises four wings disposed about an outer perimeter of the spacer (the cover 21 has four resilient engaging members 21b around its outer perimeter) (Katsui; Fig. 9; col. 9, lines 44-53). Moreover, according to the MPEP 2144.04(VI)(B), the mere duplication of parts has no patentable significance unless a new an unexpected result is produced. As the inclusion of one more wing to the spacer would not produce an unexpected result, 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 modified Binversie spacer by duplicating one of the wings such that the spacer thereby comprises five wings, as taught by the MPEP, for the purpose of more securely attaching the spacer to the heat sink.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Binversie in view of Zeutzius as applied to claims 1 and 11 above, and further in view of Toth (US 2010/0056966 A1).
Regarding claims 10 and 20, the modified Binversie teaches the invention as previously claimed, but does not teach wherein the wearable therapy delivery device comprises a footwear item.
However, Binversie does disclose the garment 30 of the invention can be used to fit various parts of the patient’s body to be treated (Binversie; para. [0035]). Furthermore, Toth teaches a device for the compressive treatment of a body part (Toth; abstract) wherein the wearable therapy delivery device comprises a footwear item (compressive device 1 can be formed to fit a foot with an attachment arrangement such as a sleeve, hook-and-loop device, strings, etc.) (Toth; para. [0173]).
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 Binversie device to include a footwear item, as taught by Toth, for the purpose of enabling the device to treat a patient’s foot as desired (Toth; para. [0173]).
Response to Arguments
Applicant's arguments filed 5/4/2026 have been fully considered but they are not persuasive.
On page 7 in the last two paragraphs of the Applicant’s remarks, the Applicant argues that the drawings and claims have been amended to overcome the objections of the previous office action. The Examiner agrees, and has thus withdrawn those objections.
On page 8 in the first paragraph of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 112(b) rejections of the previous office action. The Examiner agrees, and has thus withdrawn those 35 U.S.C. 112(b) rejections.
On page 8 in the second paragraph of the Applicant’s remarks, the Applicant argues that they did not intend to have any claim limitations interpreted under 35 U.S.C. 112(f), and that they recite sufficient structure to perform the claimed function so as to avoid such interpretations. However, the Examiner respectfully disagrees. The claim limitations being interrupted under 35 U.S.C. 112(f) do not recite sufficient structure to perform their claimed functions, but rather recite the generic placeholders of “modules”, “unit”, and “item”. Thus, the 35 U.S.C. 112(f) interpretations of the previous office action are being maintained as detailed above.
Applicant’s arguments in the “Claim Rejections Under 35 U.S.C. 102/103” section on pages 8-9 of the Applicant’s remarks with respect the newly added battery pack operatively attached to an outside surface of the wearable therapy delivery device limitation have been considered but are moot in view of new grounds of rejection with new additional Zeutzius reference being used in the current rejection as discussed above.
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 JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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