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 .
Claim Objections
Claims 1-5, 8-14, 17, and 20 are objected to because of the following informalities:
Claim 1 recites “said segment” in line 2 and is suggested to read --said at least one segment-- in order to more clearly reference how the limitation was originally claimed.
Claim 1 recites “the segment” in line 4 and is suggested to read --the at least one segment-- in order to more clearly reference how the limitation was originally claimed.
Claim 1 recites “said hardware device” in lines 7-8 and is suggested to read --said at least one hardware device-- in order to more clearly reference how the limitation was originally claimed.
Claim 1 recites “the hardware device” in line 10 and is suggested to read --the at least one hardware device-- in order to more clearly reference how the limitation was originally claimed.
Claim 1 recites “said hardware device” in lines 10-11 and is suggested to read --said at least one hardware device-- in order to more clearly reference how the limitation was originally claimed.
Claim 1 recites “said hardware device” in lines 11-12 and is suggested to read --said at least one hardware device-- in order to more clearly reference how the limitation was originally claimed.
Claim 1 recites “the control module” in line 12 and is suggested to read --the at least one main central control module-- in order to more clearly reference how the limitation was originally claimed.
Claim 2 recites “following including:” in line 2 and is suggested to read --following:-- in order to avoid redundancy.
Claim 3 recites “layers;” in line 2 and is suggested to read --layers comprising;-- in order to provide clarity.
Claim 3 recites “said layer” in line 4 and is suggested to read --said first layer-- in order to more clearly reference how the limitation was originally claimed.
Claim 3 recites “said layer” in line 9 and is suggested to read --said fourth layer-- in order to more clearly reference how the limitation was originally claimed.
Claim 4 recites “the segments” in line 8 and is suggested to read --the at least one segment-- in order to more clearly reference how the limitation was originally claimed.
Claim 4 recites “the suit.” in lines 8-9 and is suggested to read --the bodysuit.-- in order to more clearly reference how the limitation was originally claimed.
Claim 5 recites “the hardware” in line 1 and is suggested to read --the at least one hardware device-- in order to more clearly reference how the limitation was originally claimed.
Claim 8 recites “the IO devices” in lines 1-2 and is suggested to read --the input/output (IO) devices-- in order to provide clarity of the acronym.
Claim 9 recites “the body suit” in line 6 and is suggested to read --the bodysuit-- (i.e. get rid of the extra space) in order to more clearly reference how the limitation was originally claimed.
Claim 9 recites “the primary central control module,” in lines 18-19 and is suggested to read --the primary central control modules,-- in order to more clearly reference how the limitation was originally claimed.
Claim 9 recites “the primary central control module” in line 19 and is suggested to read --the primary central control modules-- in order to more clearly reference how the limitation was originally claimed.
Claim 9 recites “the main central control module,” in line 20 and is suggested to read --the at least one main central control module,-- in order to more clearly reference how the limitation was originally claimed.
Claim 9 recites “and the main central control module” in line 20 and is suggested to read --and the at least one main central control module-- in order to more clearly reference how the limitation was originally claimed.
Claim 10 recites “the biometric data” in line 6 and is suggested to read --the plurality of biometric data-- in order to more clearly reference how the limitation was originally claimed.
Claim 11 recites “enzymatically liquid” in line 5 and is suggested to read --enzymatically encapsulated liquid-- in order to more clearly reference how the limitation was originally claimed.
Claim 12 recites “said segment” in line 2 and is suggested to read --said at least one segment-- in order to more clearly reference how the limitation was originally claimed.
Claim 12 recites “the segment” in line 4 and is suggested to read --the at least one segment-- in order to more clearly reference how the limitation was originally claimed.
Claim 12 recites “the main central control module” in lines 5-6 and is suggested to read --the at least one the main central control module-- in order to more clearly reference how the limitation was originally claimed.
Claim 12 recites “the primary central control module” in line 6 and is suggested to read --the at least one the primary central control module-- in order to more clearly reference how the limitation was originally claimed.
Claim 12 recites “the segment” in line 6 and is suggested to read --the at least one segment-- in order to more clearly reference how the limitation was originally claimed.
Claim 12 recites “following including:” in line 8 and is suggested to read --following:-- in order to avoid redundancy.
Claim 13 recites “layers;” in line 2 and is suggested to read --layers comprising;-- in order to provide clarity.
Claim 13 recites “said layer” in line 4 and is suggested to read --said first layer-- in order to more clearly reference how the limitation was originally claimed.
Claim 13 recites “said layer” in line 9 and is suggested to read --said fourth layer-- in order to more clearly reference how the limitation was originally claimed.
Claim 14 recites “said device” in line 9 and is suggested to read --said at least one input/output device-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “said segment” in line 2 and is suggested to read --said at least one segment-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “the segment” in line 4 and is suggested to read --the at least one segment-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “the main central control module” in lines 5-6 and is suggested to read --the at least one the main central control module-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “the primary central control module” in line 6 and is suggested to read --the at least one the primary central control module-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “the segment” in line 6 and is suggested to read --the at least one segment-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “following including:” in line 8 and is suggested to read --following:-- in order to avoid redundancy.
Claim 17 recites “connection” in line 24 and is suggested to read --connection;-- in order to be grammatically correct.
Claim 17 recites “the segment” in line 25 and is suggested to read --the at least one segment-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “said hardware device” in lines 25-26 and is suggested to read --said at least one hardware device-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “the hardware device” in line 28 and is suggested to read --the at least one hardware device-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “the segment” in line 28 and is suggested to read --the at least one segment-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “said hardware device” in lines 28-29 and is suggested to read --said at least one hardware device-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “said hardware device” in lines 29-30 and is suggested to read --said at least one hardware device-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “the primary central control module” in line 30 and is suggested to read --the at least one the primary central control module-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “the main central control module;” in lines 30-31 and is suggested to read --the at least one the main central control module;-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “the material” in line 32 and is suggested to read --the multi-layered material-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “said layer” in line 35 and is suggested to read --said first layer-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “said layer” in line 40 and is suggested to read --said fourth layer-- in order to more clearly reference how the limitation was originally claimed.
Claim 20 recites “the hardware devices” in line 1 and is suggested to read --the at least one hardware device-- in order to more clearly reference how the limitation was originally claimed.
Claim 20 recites “the IO devices” in lines 1-2 and is suggested to read --the input/output (IO) devices-- in order to provide clarity of the acronym.
Claim 20 recites “the main central control module” in line 2 and is suggested to read --the at least one the main central control module-- in order to more clearly reference how the limitation was 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 limitations use 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: “a pressurization function” in claim 3 lines 7-8, claim 13 line 8, and claim 17 line 39, and “to interact wirelessly…via a wearable device” in claim 6 lines 2-3, claim 15 lines 2-3, and claim 18 lines 2-3.
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 page 12 lines 4-9, the limitation of “to interact wirelessly…via a wearable device” in claim 6 lines 2-3, claim 15 lines 2-3, and claim 18 lines 2-3 is being interpreted as comprising a biometric ring, and 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 1-20 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 1, the limitation “input/output” in line 8 is confusing, as it is unclear whether the “/” is meant to mean “and”, “or”, or “and/or”, and thus the scope of the claim is indefinite. Moreover, the phrase "such as" in line 8 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Furthermore, the limitation "the capability" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 2, the limitation “a wearer” in line 3 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “a wearer” in claim 1. For the purposes of examination, they will be interpreted as the same limitation.
Regarding claim 4, the limitation “a main control module” in line 4 is confusing, as it is unclear whether this limitation is meant to be the same as or different from the “at least one main central control module” in claim 1. For the purposes of examination, it will be interpreted as part of the “at least one main central control module” limitation of claim 1.
Regarding claim 6, the limitation “wearers” in line 2 is confusing, as it is unclear whether this limitation is meant to include or be separate from “a wearer” in claim 1. For the purposes of examination, it will be interpreted as including the “a wearer” limitation of claim 1.
Regarding claim 8, the limitation “the IO devices” in lines 1-2 is confusing, as only “an input/output device” was claimed in claim 1, and thus the scope of the claim is unclear.
Regarding claim 9, the limitations “performs” in line 2, “facilitates” in line 4, “increases providing” in lines 6-7, “expands” in line 9, “restricting” in line 9, “providing” in line 9, “expands” in line 12, “restricting” in line 12, “providing” in line 12, “contracts” in line 15, “compares” in line 21, “diagnosis” in line 22, “facilitates” in line 23, “are delivered” in line 25, and “are taken” in line 29 are confusing, as these limitations recite method steps within a device claim, thereby rendering the scope of the invention unclear. It is suggested to use claim language such as --configured to-- or --adapted for-- in order to avoid such indefiniteness. Additionally, the limitation "the user interface" is recited in line 21. There is insufficient antecedent basis for this limitation in the claim. Moreover, the limitation “a wearer” in line 24 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “a wearer” in claim 1. For the purposes of examination, they will be interpreted as the same limitation. Furthermore, the limitation “biometric reads” in line 28 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “biometric data” in line 2.
Regarding claim 10, the limitations “the steps” in line 1, “perform” in line 3, “monitor” in line 5, “record” in line 6, and “compile” in line 7 are confusing, as these limitations recite method steps within a device claim, thereby rendering the scope of the invention unclear. It is suggested to use claim language such as --configured to-- or --adapted for-- in order to avoid such indefiniteness. Also, it is unclear by what specific structure(s) of the bodysuit these limitations are being performed. Moreover, the limitation “a plurality of biometric data” in line 5 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “biometric reads” in line 3. Furthermore, the limitation “the data and information” in line 7 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “biometric reads” in line 3 and/or “a plurality of biometric data” in line 5.
Regarding claim 11, the limitations “the steps” in line 2, “are ingested” in line 3, “are delayed” in line 5, “are directed” in line 7, and “stimulates” are confusing, as these limitations recite method steps within a device claim, thereby rendering the scope of the invention unclear. It is suggested to use claim language such as --configured to-- or --adapted for-- in order to avoid such indefiniteness. Moreover, the limitation “nanomino enzymatically liquid amino acids” in line 5 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “nanomino enzymatically encapsulated liquid amino acids” in line 3. Furthermore, the limitation “amino acids” in line 7 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “nanomino enzymatically encapsulated liquid amino acids” in line 3 and/or “nanomino enzymatically liquid amino acids” in line 5. Also, these limitations are not a part of the bodysuit, which is the device being claimed as defined in line 1, and thus the scope of the invention is unclear. Furthermore, the limitation “bodysuit” in line 8 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “a bodysuit” in claim 1.
Regarding claim 12, the limitation “a wearer” in lines 9-10 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “a wearer” in line 3. For the purposes of examination, they will be interpreted as the same limitation.
Claim 14 recites the limitation "the areas" in line 2. There is insufficient antecedent basis for this limitation in the claim. Moreover, the limitation “input/output” in line 8 is confusing, as it is unclear whether the “/” is meant to mean “and”, “or”, or “and/or”, and thus the scope of the claim is indefinite.
Regarding claim 15, the limitation “wearers” in line 2 is confusing, as it is unclear whether this limitation is meant to include or be separate from “a wearer” in claim 12. For the purposes of examination, it will be interpreted as including the “a wearer” limitation of claim 12.
Regarding claim 17, the limitation “a wearer” in lines 9-10 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “a wearer” in line 3. For the purposes of examination, they will be interpreted as the same limitation. Moreover, the limitation “input/output” in line 26 is confusing, as it is unclear whether the “/” is meant to mean “and”, “or”, or “and/or”, and thus the scope of the claim is indefinite. Furthermore, the phrase "such as" in line 26 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 18, the limitation “wearers” in line 2 is confusing, as it is unclear whether this limitation is meant to include or be separate from “a wearer” in claim 17. For the purposes of examination, it will be interpreted as including the “a wearer” limitation of claim 17.
Regarding claim 20, the limitation “the hardware devices and the IO devices” in lines 1-2 is confusing, as this implies two different structures while claim 17 from which this claim depends recites “wherein said hardware device in an input/output device” in lines 25-26 which implies these limitations are the same structure.
Claims 3, 13, and 17 contain the trademark/trade name Kevlar. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe poly-paraphenylene terephthalamide and, accordingly, the identification/description is indefinite.
Claim limitation “a pressurization function” in claim 3 lines 7-8, claim 13 line 8, and claim 17 line 39 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Any remaining claims are rejected based on their dependency on a rejected base claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Each of the claims 1-4, 9, 11-13, and 17 positively recites a “wearer” as a part of the claimed invention (e.g. “covers at least a portion of a body of a wearer” in claim 1 lines 2-3, and “said layer is proximate the body of the wearer” in claim 2 line 4), thereby encompassing a human organism. It is suggested to use claim language such as --configured for-- or --adapted to-- in order to avoid positively reciting a human organism.
Any remaining claims are rejected based on their dependency on a rejected base claim.
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 1-2, 12, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ballas et al. (US 2012/0065561 A1).
Regarding claim 1, as best understood, Ballas discloses a bodysuit (a cuff to be placed around an extremity) (Fig. 1; abstract) comprising:
at least one segment wherein said segment covers at least a portion of a body of a wearer (compression devices 102a, 102b each cover a respective calf of a user’s body) (Fig. 1; para. [0037]);
the segment further comprising at least one main central control module wherein said main central control module is coupled to the segment of the bodysuit (at least one of the control units 108a/212a and 108b/212b, each of which are coupled to a respective compression device 102a, 102b; additionally or alternatively, a computer system 116 and/or a remote control unit 106 which can both be wirelessly coupled to the compression device 102a, 102b via communications links 110, 112, 118) (Fig. 1-2; para. [0040]; para. [0044]; paras. [0048-0050]);
the segment further comprising at least one hardware device wherein said hardware device is an input/output device such as a biometric sensor, an accelerometer, a gyroscope, and a wireless transmitter (sensors such as pressure sensors, flow rate sensors, and inertial sensors; inertial sensors can include accelerometers and/or gyroscopes; additionally or alternatively, remote control unit 106 with wireless communication links 110, 112) (Fig. 1; para. [0040]; para. [0048]; para. [0107]);
the hardware device coupled to the segment of the bodysuit (sensors are included in the control units 212a, 212b, and so are coupled to respective compression devices 102a, 102b; the remote control unit 106 is wirelessly coupled to the control units of respective compression devices 102a, 102b via wireless communication links 110, 112) (Figs. 1-2; para. [0040]; para. [0048]), wherein said hardware device has the capability to wirelessly transmit data between said hardware device and the control module (the remote control unit 106 uses wireless communication links 110, 112 to communicate with the control units 108a, 108b to control operations; data from the sensors of control unit 212 is supplied to the computer system 116 through the remote control unit 106, which communicates wirelessly with the control units) (Fig. 1; para. [0040]; para. [0050]).
Regarding claim 2, as best understood, Ballas discloses wherein the at least one segment comprises at least one of the following including: a leg sleeve comprising a first opening proximate a lower portion of a leg of the wearer and a second opening proximate an upper portion of the leg of the wearer wherein said leg sleeve covers at least a portion of the leg of the wearer (cuffs 200a, 200b cover the calves; each cuff 200a, 200b comprises a bottom opening for a lower portion of the calf and a top opening for an upper portion of the calf) (Figs. 1-2; para. [0047]).
Regarding claim 12, as best understood, Ballas discloses a bodysuit (a cuff to be placed around an extremity) (Fig. 1; abstract) comprising:
at least one segment wherein said segment covers at least a portion of a body of a wearer (compression devices 102a, 102b each cover a respective calf of a user’s body) (Fig. 1; para. [0037]);
the segment further comprising at least one main central control module and at least one primary central control module wherein the main central control module and the primary central control module are coupled to the segment of the bodysuit (the control units 108a/212a and 108b/212b, each of which are coupled to a respective compression device 102a, 102b; control units 108a/212a or 108b/212b can be used to control the overall coordinated operations of individual compression devices 102, and thus one can control the other’s operation) (Fig. 1-2; para. [0040]; para. [0042]; paras. [0048-0049]);
the at least one segment comprises at least one of the following including:
a leg sleeve comprising a first opening proximate a lower portion of a leg of the wearer and a second opening proximate an upper portion of the leg of the wearer wherein said leg sleeve covers at least a portion of the leg of the wearer (cuffs 200a, 200b cover the calves; each cuff 200a, 200b comprises a bottom opening for a lower portion of the calf and a top opening for an upper portion of the calf) (Figs. 1-2; para. [0047]).
Regarding claim 16, Ballas discloses further comprising at least one primary reserve control module (any one of the computer system 116, the remote control unit 106, or any additional control units associated with additional compression devices) (Fig. 1; para. [0042]; para. [0045]).
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 3, 7, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Ballas as applied to claims 2 and 12 above, and further in view of Falconio-West et al. (US 2014/0107546 A1), Wang et al. (US 2022/0047447 A1), Whalen et al. (US 2017/0224357 A1), Connor (US 2015/0309563 A1), and Lowe et al. (US 2013/0190203 A1).
Regarding claim 3, Ballas discloses the invention as previously claimed, including wherein said bodysuit is composed of a material comprising a plurality of layers (compression device 102 has a protective outer sleeve 216 with an inner and an outer layer, as well as the material for cuffs 200a and 200b with a bladder system 204a) (Ballas; Fig. 2; para. [0048]; para. [0122]) and a pressurization function of the bodysuit (pumps 208a, 208b to pump fluid into or from the membranes 206a, 206b) (Ballas; Fig. 2; para. [0048]), but does not teach a first, inwardly facing, layer composed of a nylon tricot material, wherein said layer is proximate the body of the wearer; a second layer composed of spandex, adjacent to the first layer; a third layer composed of urethane coated nylon adjacent to the second layer, wherein said third layer is able to expand and contract through a pressurization function of the bodysuit; a fourth layer, wherein said layer is an outwardly facing layer, composed of a weaved material comprising Kevlar and graphene; and a plurality of carbon nanotubes suspended in polyethylene glycol, wherein said carbon nanotubes are interposed within the plurality of layers.
However, Falconio-West teaches a compression device (Falconio-West; abstract) including a first, inwardly facing, layer composed of a nylon tricot material, wherein said layer is proximate the body of the wearer (wrap 101 is made of nylon tricot, and is proximate to and facing inwards towards the user’s leg) (Falconio-West; Figs. 1, 8; para. [0028]).
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 Ballas bodysuit material to include a first, inwardly facing, layer composed of a nylon tricot material, wherein said layer is proximate the body of the wearer, as taught by Falconio-West, for the purpose of providing the device with a suitable material that does not run or snag easily (Falconio-West; para. [0028]).
However, Ballas does teach a second layer composed of an elastic material, adjacent to the first layer (the sleeve 216 can be formed with an additional elastic fabric, which would be adjacent to the inner layer of the sleeve 216) (Ballas; Fig. 2; para. [0122]). Moreover, Wang teaches a device for applying pneumatic pressure (Wang; abstract) including an elastic material composed of spandex (flexible wrap 108 made of fabric that is elastic in nature, such as Spandex) (Wang; para. [0043]).
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 Ballas elastic material to be composed of spandex, as taught by Wang, for the purpose of providing a specific suitable elastic fabric to make it easier to put the compression device on the patient and to accommodate differently sized users (Ballas, para. [0122]; Wang, para. [0043]).
However, Whalen teaches an inflatable belt system (Whalen; abstract) including a third layer composed of urethane coated nylon adjacent to the second layer, wherein said third layer is able to expand and contract through a pressurization function of the bodysuit (inflatable belt 100 has an outer layer made of urethane coated ballistic nylon, which can stretch 5% when subject to a stretching force, and which would be adjacent to an inner layer) (Whalen; para. [0124]; para. [0203]).
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 Ballas material to include a third layer composed of urethane coated nylon adjacent to the second layer, wherein said third layer is able to expand and contract through a pressurization function of the bodysuit, as taught by Whalen, for the purpose of allowing the inflatable device to provide a harder, stronger response to accommodate a user with big strong limbs (Whalen; para. [0124]).
However, Connor teaches a clothing accessory for measuring body motion (Connor; abstract) including a fourth layer, wherein said layer is an outwardly facing layer, composed of a weaved material comprising Kevlar and graphene (wearable energy pathways that face outwards are made of a non-conductive fiber such as Kevlar and a conductive material such as graphene) (Connor; Fig. 1; para. [0152]).
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 Ballas material to include a fourth layer, wherein said layer is an outwardly facing layer, composed of a weaved material comprising Kevlar and graphene, as taught by Connor, for the purpose of enabling the device to measure body motion, posture, and/or configuration (Connor; abstract).
However, Lowe teaches a device worn by a user (Lowe; Figs. 1-2; abstract) including a plurality of carbon nanotubes suspended in polyethylene glycol, wherein said carbon nanotubes are interposed within the plurality of layers (aptamers 110 are functionalized with conductive components such as carbon nanotubes and attached to a surface with a stabilizer such as PEG; aptamers can form a sensor 130 distributed throughout the fabric) (Lowe; paras. [0036-0037]).
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 Ballas device to include a plurality of carbon nanotubes suspended in polyethylene glycol, wherein said carbon nanotubes are interposed within the plurality of layers, as taught by Lowe, for the purpose of enabling the device to sense threats, hazards, and contaminants (Lowe; para. [0034]).
Regarding claim 7, the modified Ballas teaches further comprising at least one primary reserve control module (any one of the computer system 116, the remote control unit 106, or any additional control units associated with additional compression devices) (Ballas; Fig. 1; para. [0042]; para. [0045]).
Regarding claim 13, as best understood, the modified Ballas teaches wherein said bodysuit is composed of a material comprising a plurality of layers; a first, inwardly facing, layer composed of a nylon tricot material, wherein said layer is proximate the body of the wearer (wrap 101 is made of nylon tricot, and is proximate to and facing inwards towards the user’s leg) (Falconio-West; Figs. 1, 8; para. [0028]); a second layer composed of spandex, adjacent to the first layer (the Ballas sleeve 216 can be formed with an additional elastic fabric, which would be adjacent to the inner layer of the sleeve 216; Wang teaches a fabric that is elastic in nature can be Spandex) (Ballas, Fig. 2, para. [0122]; Wang, para. [0043]); a third layer composed of urethane coated nylon adjacent to the second layer, wherein said third layer is able to expand and contract (inflatable belt 100 has an outer layer made of urethane coated ballistic nylon, which can stretch 5% when subject to a stretching force, and which would be adjacent to an inner layer) (Whalen; para. [0124]; para. [0203]) through a pressurization function of the bodysuit (pumps 208a, 208b to pump fluid into or from the membranes 206a, 206b) (Ballas; Fig. 2; para. [0048]); a fourth layer, wherein said layer is an outwardly facing layer, composed of a weaved material comprising Kevlar and graphene (wearable energy pathways that face outwards are made of a non-conductive fiber such as Kevlar and a conductive material such as graphene) (Connor; Fig. 1; para. [0152]); and a plurality of carbon nanotubes suspended in polyethylene glycol, wherein said carbon nanotubes are interposed within the plurality of layers (aptamers 110 are functionalized with conductive components such as carbon nanotubes and attached to a surface with a stabilizer such as PEG; aptamers can form a sensor 130 distributed throughout the fabric) (Lowe; paras. [0036-0037]).
Claims 4-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Ballas as applied to claim 2 above, and further in view of Ross, Jr. (US 2014/0012161 A1).
Regarding claim 4, as best understood, the modified Ballas teaches the invention as previously claimed, including the bodysuit further comprising a plurality of primary central control modules wherein said primary central control modules communicate via wireless transmission to the main central control modules the primary central control modules being coupled to the segments of the suit (the control units 108a/212a and 108b/212b, each of which are coupled to a respective compression device 102a, 102b; control units 108a/212a and 108b/212b can communicate with a computer system 116 and/or a remote control unit 106 wirelessly via communications links 110, 112, 118) (Ballas; Fig. 1-2; para. [0040]; para. [0044]; paras. [0048-0050]), but does not teach wherein at least one of the following segments including the front facing side of the torso cover, the rear facing side of the torso cover, and a portion of the bodysuit proximate a waist of the wearer comprise a main control module coupled to the segment of the bodysuit.
However, Ross teaches a therapeutic sleeve apparatus (Ross; abstract) wherein at least one of the following segments including the front facing side of the torso cover comprise a main control module coupled to the segment of the bodysuit (data collector 50 is in a pocket 46 on the front of the shirt body 20) (Ross; Figs. 1-2; para. [0036]).
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 Ballas segments and main control module such that they include the front facing side of the torso cover comprising a main control module coupled to the segment of the bodysuit, as taught by Ross, for the purpose of providing a specific suitable location for the main control module which can be easily accessed by a user.
Regarding claim 5, the modified Ballas teaches wherein the hardware further comprises a processor, a memory storage device, and a power supply (a microprocessor, non-volatile FLASH memory, and power circuitry for the power supply) (Ballas; para. [0130]).
Regarding claim 8, as best understood, the modified Ballas teaches wherein the hardware devices and the IO devices provide data to the main central control module to facilitate a plurality of functions (the remote control unit 106 uses wireless communication links 110, 112 to communicate with the control units 108a, 108b to control operations, including control modes; data from the sensors of control unit 212 is supplied to the computer system 116 through the remote control unit 106, which communicates wirelessly with the control units) (Ballas; Fig. 1; para. [0040]; para. [0050]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ballas in view of Ross as applied to claim 8 above, and further in view of Ciluffo (US 2006/0122544 A1) and Amirouche (US 2013/0345650 A1).
Regarding claim 9, as best understood, the modified Ballas teaches the invention as previously claimed, including wherein the plurality of functions comprise: a first function wherein bodysuit performs a collection of biometric data of the wearer (sensors collect data on the vital signs of the patient, such as heart rate, breathing rate, venous flow, etc.) (Ballas; para. [0050]; para. [0053]); a fourth function wherein the third layer of the multi-layered material expands thus restricting a flow of blood, and thus providing a cooling sensation, to a portion of the body of the wearer to simulate cold therapy; a fifth function wherein the third layer of the multi-layered material expands thus compressing a portion of the body of the wearer, providing a compression therapy to the wearer; a sixth function wherein the third layer of the multi-layered material contracts thus decompressing a portion of the body of the wearer (compression device has a cuff on a patient’s extremity, the cuff having a bladder system; the bladder system can be inflated, expanded, and/or contracted around the patient’s extremity as claimed, and thus it would thereby function to provide a cooling sensation, compression therapy, and decompression to that extremity as claimed) (Ballas; Fig. 2; para. [0048]; para. [0140]); a seventh function wherein the processor and wireless transmitter communicate the data acquired from the biometric sensors to the primary central control module, the primary central control module transmitting the data to the main central control module, and the main central control module transmitting the data to the user interface (data from the sensors of control unit 212 is wirelessly supplied to the remote control unit 106, which then communicates wirelessly with the control units and the computer system 116; computer system 116 can use a communication link 120 to send information to a further remote location which can be used by a physician to treat a patient and so would have a user interface) (Ballas; Fig. 1; para. [0040]; para. [0043-0044]; para. [0050]); an eighth function wherein the bodysuit facilitates the enhancement, repair, recovery, and rehabilitation of a muscle of a wearer (the compression devices function to treat patient extremities with circulatory conditions; by improving fluid flow in an extremity, the compression device would thus be helping to facilitate the enhancement, repair, recovery, and rehabilitation of the muscle of that extremity) (Ballas; paras. [0002-0003]; para. [0037]), but does not teach a second function wherein the bodysuit facilitates the uptake of nanoparticles throughout the body of the wearer; a third function wherein the temperature of the body suit increases providing a heat therapy to the wearer; a seventh function wherein the biometric sensors detect and measure electrical signals from nerves throughout the body, wherein the user interface compares electrical signals throughout the body and diagnoses nerve imbalances; a ninth function wherein electrical impulses are delivered through the bodysuit to increase circulation, increase mobility, assist in healing, and facilitate recovery; and a tenth function wherein biometric reads are taken by the biometric sensors to detect and facilitate the uptake of pharmaceutical products.
However, Ciluffo teaches medical or therapeutic garments (Ciluffo; abstract) including
a second function wherein the bodysuit facilitates the uptake of nanoparticles throughout the body of the wearer (According to the Applicant’s specification page 12 lines 26-31 and page 13 line 1-7, the facilitation of nanoparticle uptake is due to the device emitting an electromagnetic signal to an area of the body. As Ciluffo teaches fabric near the joints can include electromagnets which are energized, which then would affect the joint with its magnetic field, Ciluffo would thereby perform the claimed function of facilitating the uptake of nanoparticles throughout the body of the wearer.) (Ciluffo; para. [0031]); a ninth function wherein electrical impulses are delivered through the bodysuit to increase circulation, increase mobility, assist in healing, and facilitate recovery (As Ciluffo teaches an electrical stimulus can be applied to a wearer by the fabric as claimed, it would thus be able to function to increase circulation, increase mobility, assist in healing, and facilitate recovery as functionally claimed.) (Ciluffo; para. [0024]; para. [0039]; claims 13-14).
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 Ballas device to include a second function wherein the bodysuit facilitates the uptake of nanoparticles throughout the body of the wearer and a ninth function wherein electrical impulses are delivered through the bodysuit to increase circulation, increase mobility, assist in healing, and facilitate recovery, as taught by Ciluffo, for the purpose of providing an additional magnetic, electrical stimulation, and electric shock therapies and treatments (Ciluffo; paras. [0009-0010]; para. [0024]; para. [0031]; para. [0039]; claims 13-14).
However, Ross further teaches a third function wherein the temperature of the body suit increases providing a heat therapy to the wearer (heating coils 110 in the sleeve 10 to provide heat to a wearer during rehabilitation exercises) (Ross; Fig. 3; para. [0044]).
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 Ballas device to include a third function wherein the temperature of the body suit increases providing a heat therapy to the wearer, as taught by Ross, for the purpose of helping to facilitate rehabilitation exercises and avoid injury (Ross; para. [0044]).
However, Amirouche teaches a medical device of a wearable patch (Amirouche; abstract) including a seventh function wherein the biometric sensors detect and measure electrical signals from nerves throughout the body, wherein the user interface compares electrical signals throughout the body and diagnoses nerve imbalances (medicament delivery system 10 has one or more sensors to monitor nerve conduction velocity of a patient by detecting the electrical impulses between electrodes at different locations on the user’s body, and then determining if a nerve is damaged if the electrical signal is slower/weaker) (Amirouche; Fig. 12; paras. [0081-0082]); a tenth function wherein biometric reads are taken by the biometric sensors to detect and facilitate the uptake of pharmaceutical products (information such as the health of the patient’s nerves, EMG tests, or other tests for measuring and assessing patient parameters such as blood glucose levels are used to provide feedback to the medicament delivery system 10, which can then adjust its dosing levels, rate, or type of medicament delivered) (Amirouche; para. [0083]).
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 Ballas functions to include a seventh function wherein the biometric sensors detect and measure electrical signals from nerves throughout the body, wherein the user interface compares electrical signals throughout the body and diagnoses nerve imbalances and a tenth function wherein biometric reads are taken by the biometric sensors to detect and facilitate the uptake of pharmaceutical products, as taught by Amirouche, for the purpose of helping to optimize patient dosing while minimizing potential side effects (Amirouche; para. [0083]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ballas in view of Ross, Ciluffo, and Amirouche as applied to claim 9 above, and further in view of Shipley et al. (US 2009/0036938 A1).
Regarding claim 10, as best understood, the modified Ballas teaches the invention as previously claimed, but does not teach wherein the first function comprises the steps of: perform biometric reads of electrical impulses, oxygen saturation, blood pressure, and systematic imbalances; monitor a plurality of biometric data over an interval of time; record the biometric data; and compile the data and information acquired by the biometric sensors.
However, Shipley teaches a system for delivering external counterpulsation therapy (Shipley; abstract) including the steps of: perform biometric reads of electrical impulses, oxygen saturation, blood pressure, and systematic imbalances; monitor a plurality of biometric data over an interval of time; record the biometric data; and compile the data and information acquired by the biometric sensors (cardiac sensors and hemodynamic sensors to detect electrical signals from an ECG, blood pressure, blood oxygen concentration, heart sounds, blood flow, etc.; data from sensors is collected over time periodically; as measurements from the sensors are taken for calculations, they are recorded in the memory and compiled) (Shipley; para. [0009]; para. [0012]; paras. [0014-0015]).
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 Ballas device to include the function of performing biometric reads of electrical impulses, oxygen saturation, blood pressure, and systematic imbalances; monitoring a plurality of biometric data over an interval of time; recording the biometric data; and compiling the data and information acquired by the biometric sensors, as taught by Shipley, for the purpose of synchronizing the counterpulsation to the cardiac cycle (Shipley; para. [0009]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ballas in view of Ross, Ciluffo, and Amirouche as applied to claim 9 above, and further in view of Vanquickenbourne (WO 2016/087263 A1) and Zhou et al. (“Enzyme-Instructed Self-Assembly: A Multistep Process for Potential Cancer Therapy” article attached).
Regarding claim 11, as best understood, the modified Ballas teaches the invention as previously claimed, but does not teach wherein the second function comprises the steps of: nanomino enzymatically encapsulated liquid amino acids are ingested by wearer; release of nanomino enzymatically liquid amino acids are delayed using a prolonged release capsule; amino acids are directed to a target area; and bodysuit stimulates a portion of the body proximate the target area of the body of the wearer.
However, Vanquickenbourne teaches a comestible dosage form article for administration to a target subject (Vanquickenbourne; abstract) wherein nanomino encapsulated liquid nano amino acids and enzymes are ingested by wearer; release of nanomino encapsulated liquid nano amino acids and enzymes are delayed using a prolonged release capsule; amino acids are directed to a target area (medicament is stored in a capsule article, which is swallowed; medicament compounds for delivery can include the liquid form of amino acids, which one of ordinary skill in the art would know to be nano-sized, and enzymes; the capsule article is used for the delayed release of the stored medicament; the medicament would naturally be up-taken by the patient’s body and directed to a target area for use) (Vanquickenbourne; page 8 lines 1-2, 10-14; page 10 lines 18-21; page 12 lines 2-9). Moreover, Chen teaches a process of using enzyme-instructed self-assembly (Zhou; abstract) to self-assemble molecules such as amino acids (Zhou; page 994 first paragraph in the right column).
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 Ballas device to include the function of wherein nanomino encapsulated liquid amino acids and enzymes are ingested by wearer; release of nanomino liquid amino acids and enzymes are delayed using a prolonged release capsule; amino acids are directed to a target area, as taught by Vanquickenbourne, for the purpose of providing the patient with a medicament while maximizing the dose and minimizing the size of the dosage form (Vanquickenbourne; page 10 lines 18-21; page 12 lines 2-9). Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Ballas such that the nanomino encapsulated liquid amino acids are enzymatically formed, as taught by Zhou, for the purpose of providing a specific mechanism by which to assemble amino acids into a desired structure as inspired by natural processes (Zhou; page 988 in the second paragraph of the right column; page 994 first paragraph in the right column).
With this modification, the modified Ballas device would thus teach bodysuit stimulates a portion of the body proximate the target area of the body of the wearer (the Vanquickenbourne medicament would naturally be up-taken by the patient’s body and delivered to whichever portions of the body are in need, which can include the calves or body parts proximal to the calves; the Ballas compression devices 102a, 102b on the patient’s calves are stimulated with compression) (Ballas, Fig. 1, para. [0037]; Vanquickenbourne, page 10 lines 18-21, page 12 lines 2-9).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ballas in view of Ross as applied to claim 5 above, and further in view of Foldyna et al. (US 2015/0102925 A1).
Regarding claim 6, as best understood, the modified Ballas teaches the invention as previously claimed, including further comprising an interactive user interface that allows wearers to interact wirelessly to a network provided by an external server via a wearable device and a mobile phone comprising an application, but does not teach a wearable device as interpreted under 35 U.S.C. 112(f) as detailed above.
However, Foldyna teaches a device to detect the biological condition of a mammal (Foldyna; abstract) including a wearable device as interpreted under 35 U.S.C. 112(f) as detailed above (monitoring device 104 may be a ring) (Foldyna; Figs. 1A-1B; para. [0028]).
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 Ballas device to include a wearable device as interpreted under 35 U.S.C. 112(f) as detailed above, as taught by Foldyna, for the purpose of providing an additional means of monitoring a patient’s biological condition (Foldyna; para. [0028]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ballas in view of Falconio-West, Wang, Whalen, Connor, and Lowe as applied to claim 13 above, and further in view of Ross.
Regarding claim 14, as best understood, the modified Ballas teaches the invention as previously claimed, including the at least one main central control module comprising: a processor; a memory storage device; a power supply (control unit includes a microprocessor, non-volatile FLASH memory, and power circuitry for the power supply) (Ballas; para. [0130]); and at least one input/output (IO) device wherein said device comprises a biometric sensor, an accelerometer, a gyroscope, and a wireless transmitter (sensors such as pressure sensors, flow rate sensors, and inertial sensors; inertial sensors can include accelerometers and/or gyroscopes; remote control unit 106 with wireless communication links 110, 112) (Ballas; Fig. 1; para. [0040]; para. [0048]; para. [0107]), but does not teach wherein the at least one main central control module is coupled to at least one of the areas of the segments selected from a group consisting of a front facing portion of the torso cover of the bodysuit and a rear facing portion of the torso cover of the bodysuit.
However, Ross teaches a therapeutic sleeve apparatus (Ross; abstract) wherein the at least one main central control module is coupled to at least one of the areas of the segments selected from a group consisting of a front facing portion of the torso cover of the bodysuit (data collector 50 is in a pocket 46 on the front of the shirt body 20) (Ross; Figs. 1-2; para. [0036]).
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 Ballas segments and main control module such that the at least one main central control module is coupled to at least one of the areas of the segments selected from a group consisting of a front facing portion of the torso cover of the bodysuit, as taught by Ross, for the purpose of providing a specific suitable location for the main control module which can be easily accessed by a user.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ballas in view of Falconio-West, Wang, Whalen, Connor, Lowe, and Ross as applied to claim 14 above, and further in view of Foldyna.
Regarding claim 15, as best understood, the modified Ballas teaches the invention as previously claimed, including further comprising an interactive user interface that allows wearers to interact wirelessly to a network provided by an external server via a mobile phone comprising an application (control units include an operator interface, e.g. buttons and displays, that allow a user to control the device’s operation; control unit has a wireless interface to exchange data with other control modules, such as smart phones which must have an application for such interaction) (Ballas; Fig. 1; para. [0040]; para. [0107]; para. [0130]), but does not teach a wearable device as interpreted under 35 U.S.C. 112(f) as detailed above.
However, Foldyna teaches a device to detect the biological condition of a mammal (Foldyna; abstract) including a wearable device as interpreted under 35 U.S.C. 112(f) as detailed above (monitoring device 104 may be a ring) (Foldyna; Figs. 1A-1B; para. [0028]).
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 Ballas device to include a wearable device as interpreted under 35 U.S.C. 112(f) as detailed above, as taught by Foldyna, for the purpose of providing an additional means of monitoring a patient’s biological condition (Foldyna; para. [0028]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ballas in view of Falconio-West, Wang, Whalen, Connor, and Lowe.
Regarding claim 17, as best understood, Ballas discloses a bodysuit (a cuff to be placed around an extremity) (Fig. 1; abstract) composed of a multi-layered material (compression device 102 has a protective outer sleeve 216 with an inner and an outer layer, as well as the material for cuffs 200a and 200b with a bladder system 204a) (Fig. 2; para. [0048]; para. [0122]) comprising:
at least one segment wherein said segment covers at least a portion of a body of a wearer (compression devices 102a, 102b each cover a respective calf of a user’s body) (Fig. 1; para. [0037]);
the segment further comprising at least one main central control module and at least one primary central control module wherein the main central control module and the primary central control module are coupled to the segment of the bodysuit (the control units 108a/212a and 108b/212b, each of which are coupled to a respective compression device 102a, 102b; control units 108a/212a or 108b/212b can be used to control the overall coordinated operations of individual compression devices 102, and thus one can control the other’s operation) (Fig. 1-2; para. [0040]; para. [0042]; paras. [0048-0049]);
the at least one segment comprises at least one of the following including: a leg sleeve comprising a first opening proximate a lower portion of a leg of the wearer and a second opening proximate an upper portion of the leg of the wearer wherein said leg sleeve covers at least a portion of the leg of the wearer (cuffs 200a, 200b cover the calves; each cuff 200a, 200b comprises a bottom opening for a lower portion of the calf and a top opening for an upper portion of the calf) (Figs. 1-2; para. [0047]);
the segment further comprising at least one hardware device wherein said hardware device is an input/output device such as a biometric sensor, an accelerometer, a gyroscope, and a wireless transmitter (sensors such as pressure sensors, flow rate sensors, and inertial sensors; inertial sensors can include accelerometers and/or gyroscopes; remote control unit 106 with wireless communication links 110, 112) (Fig. 1; para. [0040]; para. [0048]; para. [0107]);
the hardware device coupled to the segment of the bodysuit (sensors are included in the control units 212a, 212b, and so are coupled to respective compression devices 102a, 102b; the remote control unit 106 is wirelessly coupled to the control units of respective compression devices 102a, 102b via wireless communication links 110, 112) (Figs. 1-2; para. [0040]; para. [0048]), wherein said hardware device has the capability to wirelessly transmit data between said hardware device, the primary central control module, and the main central control module (the remote control unit 106 uses wireless communication links 110, 112 to communicate with the control units 108a, 108b to control operations; data from the sensors of control unit 212 is supplied to the computer system 116 through the remote control unit 106, which communicates wirelessly with the control units) (Fig. 1; para. [0040]; para. [0050]);
the material comprising a plurality of layers (compression device 102 has a protective outer sleeve 216 with an inner and an outer layer, as well as the material for cuffs 200a and 200b with a bladder system 204a) (Fig. 2; para. [0048]; para. [0122]) and a pressurization function of the bodysuit (pumps 208a, 208b to pump fluid into or from the membranes 206a, 206b) (Fig. 2; para. [0048]).
Ballas does not teach the plurality of layers comprises a first, inwardly facing, layer composed of a nylon tricot material, wherein said layer is proximate the body of the wearer.
However, Falconio-West teaches a compression device (Falconio-West; abstract) including a first, inwardly facing, layer composed of a nylon tricot material, wherein said layer is proximate the body of the wearer (wrap 101 is made of nylon tricot, and is proximate to and facing inwards towards the user’s leg) (Falconio-West; Figs. 1, 8; para. [0028]).
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 Ballas bodysuit material to include a first, inwardly facing, layer composed of a nylon tricot material, wherein said layer is proximate the body of the wearer, as taught by Falconio-West, for the purpose of providing the device with a suitable material that does not run or snag easily (Falconio-West; para. [0028]).
Ballas does not teach the plurality of layers comprises a second layer composed of spandex, adjacent to the first layer.
However, Ballas does teach a second layer composed of an elastic material, adjacent to the first layer (the sleeve 216 can be formed with an additional elastic fabric, which would be adjacent to the inner layer of the sleeve 216) (Ballas; Fig. 2; para. [0122]). Moreover, Wang teaches a device for applying pneumatic pressure (Wang; abstract) including an elastic material composed of spandex (flexible wrap 108 made of fabric that is elastic in nature, such as Spandex) (Wang; para. [0043]).
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 Ballas elastic material to be composed of spandex, as taught by Wang, for the purpose of providing a specific suitable elastic fabric to make it easier to put the compression device on the patient and to accommodate differently sized users (Ballas, para. [0122]; Wang, para. [0043]).
Ballas does not teach the plurality of layers comprises a third layer composed of urethane coated nylon adjacent to the second layer, wherein said third layer is able to expand and contract through a pressurization function of the bodysuit.
However, Whalen teaches an inflatable belt system (Whalen; abstract) including a third layer composed of urethane coated nylon adjacent to the second layer, wherein said third layer is able to expand and contract through a pressurization function of the bodysuit (inflatable belt 100 has an outer layer made of urethane coated ballistic nylon, which can stretch 5% when subject to a stretching force, and which would be adjacent to an inner layer) (Whalen; para. [0124]; para. [0203]).
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 Ballas material to include a third layer composed of urethane coated nylon adjacent to the second layer, wherein said third layer is able to expand and contract through a pressurization function of the bodysuit, as taught by Whalen, for the purpose of allowing the inflatable device to provide a harder, stronger response to accommodate a user with big strong limbs (Whalen; para. [0124]).
Ballas does not teach the plurality of layers comprises a fourth layer, wherein said layer is an outwardly facing layer, composed of a weaved material comprising Kevlar and graphene.
However, Connor teaches a clothing accessory for measuring body motion (Connor; abstract) including a fourth layer, wherein said layer is an outwardly facing layer, composed of a weaved material comprising Kevlar and graphene (wearable energy pathways that face outwards are made of a non-conductive fiber such as Kevlar and a conductive material such as graphene) (Connor; Fig. 1; para. [0152]).
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 Ballas material to include a fourth layer, wherein said layer is an outwardly facing layer, composed of a weaved material comprising Kevlar and graphene, as taught by Connor, for the purpose of enabling the device to measure body motion, posture, and/or configuration (Connor; abstract).
Ballas does not teach the plurality of layers comprises a plurality of carbon nanotubes suspended in polyethylene glycol, wherein said carbon nanotubes are interposed within the plurality of layers.
However, Lowe teaches a device worn by a user (Lowe; Figs. 1-2; abstract) including a plurality of carbon nanotubes suspended in polyethylene glycol, wherein said carbon nanotubes are interposed within the plurality of layers (aptamers 110 are functionalized with conductive components such as carbon nanotubes and attached to a surface with a stabilizer such as PEG; aptamers can form a sensor 130 distributed throughout the fabric) (Lowe; paras. [0036-0037]).
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 Ballas device to include a plurality of carbon nanotubes suspended in polyethylene glycol, wherein said carbon nanotubes are interposed within the plurality of layers, as taught by Lowe, for the purpose of enabling the device to sense threats, hazards, and contaminants (Lowe; para. [0034]).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ballas in view of Falconio-West, Wang, Whalen, Connor, and Lowe as applied to claim 17 above, and further in view of Foldyna.
Regarding claim 18, as best understood, the modified Ballas teaches the invention as previously claimed including further comprising an interactive user interface that allows wearers to interact wirelessly to a network provided by an external server via a mobile phone comprising an application (control units include an operator interface, e.g. buttons and displays, that allow a user to control the device’s operation; control unit has a wireless interface to exchange data with other control modules, such as smart phones which must have an application for such interaction) (Ballas; Fig. 1; para. [0040]; para. [0107]; para. [0130]), but does not teach a wearable device as interpreted under 35 U.S.C. 112(f) as detailed above.
However, Foldyna teaches a device to detect the biological condition of a mammal (Foldyna; abstract) including a wearable device as interpreted under 35 U.S.C. 112(f) as detailed above (monitoring device 104 may be a ring) (Foldyna; Figs. 1A-1B; para. [0028]).
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 Ballas device to include a wearable device as interpreted under 35 U.S.C. 112(f) as detailed above, as taught by Foldyna, for the purpose of providing an additional means of monitoring a patient’s biological condition (Foldyna; para. [0028]).
Regarding claim 19, the modified Ballas teaches further comprising at least one primary reserve control module (any one of the computer system 116, the remote control unit 106, or any additional control units associated with additional compression devices) (Ballas; Fig. 1; para. [0042]; para. [0045]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ballas in view of Falconio-West, Wang, Whalen, Connor, Lowe, and Foldyna as applied to claim 19 above, and further in view of Zeutzius et al. (US 2014/0303533 A1).
Regarding claim 20, as best understood, the modified Ballas teaches the invention as previously claimed, including wherein the hardware devices and the IO devices provide data to the main central control module to facilitate a plurality of functions (the remote control unit 106 uses wireless communication links 110, 112 to communicate with the control units 108a, 108b to control operations, including control modes; data from the sensors of control unit 212 is supplied to the computer system 116 through the remote control unit 106, which communicates wirelessly with the control units) (Fig. 1; para. [0040]; para. [0050]), but does not teach including a function wherein sound waves are used to communicate information.
However, Zeutzius teaches a pneumatic compression system (Zeutzius; abstract) including a function wherein sound waves are used to communicate information (microcontroller has an audible output device 430 such as a speaker to communicate information regarding pressurization problems and low battery conditions to a user) (Zeutzius; para. [0051]).
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 Ballas functions to include a function wherein sound waves are used to communicate information, as taught by Zeutzius, for the purpose of enabling the device to provide audible alerts to inform a user of pressurization problems and low battery conditions (Zeutzius; para. [0051]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2016/0128399 A1 by Giulianotti et al. is considered to be relevant as it discloses a body suit to encase the limbs and torso with sensors and selectively operable contractive elements in the leg/arm portions.
US 2015/0297437 A1 by Neuenhalm et al. is considered to be relevant as it discloses a wireless monitoring system, multiple compression devices, and sensors.
US 2008/0222769 A1 by Natonson et al. is considered to be relevant as it discloses a detachable pressure-providing garment with an integrated feedback system.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785