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 .
Drawings
The drawings are objected to because:
Figs. 1A and 3A contain unlabeled text boxes 102, 104, 106, 108, 340, 342, 344, 346 which should be provided with a descriptive text label (e.g. box 104 could have the label --temperature modulation assembly--) (see MPEP 608.02(d)(a)).
Figs. 1B-1C, 1E-2B, 3A, 4-5A, 5E-6A, 7-8A, 9A, and 15A-17 contain improper shading (see MPEP 608.02(V)(m)).
Figs. 1E, 15A-15B, and 16-17 appear to be photographs, which are not ordinarily permitted unless they are the only practicable medium for illustrating the claimed invention (see MPEP 608.02(V)(b)(1)).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-11, 6, 9, 16, and 19 are objected to because of the following informalities:
Claim 1 line 1 recites “the device comprising” and is suggested to read --the wearable therapy device comprising-- in order to more clearly reference how the limitation was originally claimed.
Claims 2-10 line 1 recites “The device of” and is suggested to read --The wearable therapy device of-- in order to more clearly reference how the limitation was originally claimed.
Claim 6 lines 1-2 recites “the compressive therapy module and the temperature therapy module” and is suggested to read --the one or more compressive therapy modules and the one or more temperature therapy modules-- in order to more clearly reference how the limitations were originally claimed.
Claim 9 line 2 recites “the temperature therapy module and the compressive therapy module” and is suggested to read --the one or more temperature therapy modules and the one or more compressive therapy modules-- in order to more clearly reference how the limitations were originally claimed.
Claim 11 line 11 recites “the device” and is suggested to read --the wearable therapy device-- in order to more clearly reference how the limitation was originally claimed.
Claim 16 line 2 recites “the compressive therapy module and the temperature therapy module” and is suggested to read --the one or more compressive therapy modules and the one or more temperature therapy modules-- in order to more clearly reference how the limitations were originally claimed.
Claim 19 lines 2-3 recites “the temperature therapy module and the compressive therapy module” and is suggested to read --the one or more temperature therapy modules and the one or more compressive therapy modules-- in order to more clearly reference how the limitations were originally claimed.
Appropriate correction is required.
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 4 and claim 11 line 5, “compressive therapy modules” in claim 1 line 6 and claim 11 line 7, “a heating generation unit” in claim 2 line 2 and claim 12 line 2, “a control unit configured to control” in claim 9 line 1 and claim 19 line 2, and “a footwear item” in claim 10 line 1 and claim 20 lines 1-2.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-8 and 17-18 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.
Regarding claim 7, the limitation “its perimeter” in lines 1-2 is confusing, as it is unclear as to what limitation is being referenced with the term “its”, and the limitation of the “perimeter” does not have proper antecedent basis.
Regarding claim 8, the limitation “5 wings” in line 2 is confusing, as it is unclear where this limitation is meant to include the “at least one wing” of claim 7. For the purposes of examination, it will be interpreted as including the “at least one wing” limitation of claim 7.
Regarding claim 17, the limitation “its perimeter” in line 2 is confusing, as it is unclear as to what limitation is being referenced with the term “its”, and the limitation of the “perimeter” does not have proper antecedent basis.
Regarding claim 18, the limitation “5 wings” in line 2 is confusing, as it is unclear where this limitation is meant to include the “at least one wing” of claim 17. For the purposes of examination, it will be interpreted as including the “at least one wing” limitation of claim 17.
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 1-4, 6, 9, 11-14, 16, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Binversie et al. (US 2015/0182375 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 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]); 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 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).
Regarding claim 2, Binversie discloses 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) (Fig. 4-6; para. [0037]; para. [0052]).
Regarding claim 3, Binversie discloses 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) (para. [0066]).
Regarding claim 4, Binversie discloses wherein the compressive therapy module comprises an inflatable bladder (inflatable bladder 410) (Fig. 4-6; para. [0036]).
Regarding claim 6, Binversie discloses further comprising a spacer disposed between the compressive therapy module and the temperature therapy module (housing 222 is between the TEM 312 and the inflatable bladder 410) (Fig. 4-6; para. [0051]).
Regarding claim 9, Binversie discloses further comprising a control unit configured to control operation of the temperature therapy module and the compressive therapy module (control system 100 used to coordinate the operation of the temperature and compression systems) (Figs. 1, 10; abstract; para. [0041]; claim 1).
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 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).
Regarding claim 12, Binversie discloses 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) (Fig. 4-6; para. [0037]; para. [0052]).
Regarding claim 13, Binversie discloses 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) (para. [0066]).
Regarding claim 14, Binversie discloses wherein the compressive therapy module comprises an inflatable bladder (inflatable bladder 410) (Fig. 4-6; para. [0036]).
Regarding claim 16, Binversie discloses wherein the wearable therapy delivery device further comprises a spacer disposed between the compressive therapy module and the temperature therapy module (housing 222 is between the TEM 312 and the inflatable bladder 410) (Fig. 4-6; para. [0051]).
Regarding claim 19, Binversie discloses wherein the wearable therapy delivery device further comprises a control unit configured to control operation of the temperature therapy module and the compressive therapy module (control system 100 used to coordinate the operation of the temperature and compression systems) (Figs. 1, 10; abstract; para. [0041]; claim 1).
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.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Binversie 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, Binversie discloses the invention as previously claimed, but does not disclose 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 as applied to claims 1 and 11 above, and further in view of Katsui (US 6,043,980).
Regarding claims 7 and 17, as best understood, Binversie discloses the invention as previously claimed, but does not disclose wherein the spacer comprises at least one wing arranged about its perimeter.
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 arranged about its perimeter (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 arranged about its perimeter, 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, as best understood, the modified Binversie does not teach wherein the spacer comprises 5 wings.
However, the modified Binversie does teach the spacer comprises 4 wings (the cover 21 has four resilient engaging members 21b around its 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 5 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 as applied to claims 1 and 11 above, and further in view of Toth (US 2010/0056966 A1).
Regarding claims 10 and 20, Binversie discloses the invention as previously claimed, but does not disclose 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]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
GB 2540863 A by Mills et al. is considered to be relevant as it discloses an inflatable compression wrap with a thermoelectric module.
US 5,800,490 by Patz et al. is considered to be relevant as it discloses a modular device for providing heating and/or cooling therapy to a limb.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached at 571-272-4835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785