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 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 limitation(s) is/are:
“load measurement part”, “center of gravity calculation part”, “foot motion detection part”, “movement locus calculation part”, “gait recognition part”, “biosignal detection part”, “stimulation application part”, “voluntary control part”, “autonomous control part”, “optimal stimulation adjustment part” in claim 1 and “vibration detection part” in claim 4.
Because this/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.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/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 limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 5 recite “applying a physical stimulation” however the specification only provides support for electrical stimulation (e.g. [0052]) which in view of MPEP 2163(II)(A)(3)(a)(ii) does not provide sufficient disclosure as it is does not represent a representative number species to satisfy a sufficient description. Electrical stimulation is the only stimulation (e.g. [0052]) that appears to be sufficiently disclosed. While the claims recite the genus of a “a physical stimulation” is extremely broad encompassing a variety of stimulation such as thermal, chemical, optical etc. Thus, the specification does not provide support for enough species to fulfill the written description for the breadth of the genus term “a physical stimulation”.
Claims 1 and 5 recite “applying a physical stimulation”. However the specification only provides support for electrical stimulation (e.g. [0052]) which in view of MPEP 2163(II)(A)(3)(a)(ii) does not provide sufficient disclosure as it is does not represent a representative number species to satisfy a sufficient description. Electrical stimulation is the only stimulation (e.g. [0052]) that appears to be sufficiently disclosed. While the claims recite the genus of a “a physical stimulation” is extremely broad encompassing a variety of stimulation such as thermal, chemical, optical etc. Thus, the specification does not provide support for enough species to fulfill the written description for the breadth of the genus term “a physical stimulation”.
Claim 1 recites “a stimulation application part which has a terminal group”. However, the specification only provides support for electrodes that are being used to provide electrical stimulation (e.g. [0052]) which in view of MPEP 2163(II)(A)(3)(a)(ii) does not provide sufficient disclosure as it is does not represent a representative number species to satisfy a sufficient description. Electrical stimulation is the only stimulation (e.g. [0052]) that appears to be sufficiently disclosed. While the claims recite the genus of a “terminal group for applying a physical stimulation”, it is extremely broad encompassing a variety of terminal groups for applying stimulation such as thermal, chemical, optical etc. Thus, the specification does not provide support for enough species to fulfill the written description for the breadth of the genus term “terminal group for applying a physical stimulation”.
The dependent claims inherit the deficiency.
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 1-8 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.
Claims 3, 4, 7 and 8 recite the limitation "the hybrid ratio" in line 5 (in claims 3 and 4) and in line 2 (in claims 7 and 8). There is insufficient antecedent basis for this limitation in the claim.
Claims 3, 4, 7 and 8 recite the limitation "the optimal stimulation adjustment part corrects the hybrid ratio". It is unclear as to what is being referred to by the term “hybrid ratio” since no hybrid ratio is being calculated for the adjustment to be performed. It raises questions such as is the hybrid ratio of the left/right balance or some other ratio that is being determined and how is it being calculated?
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 1-4 are rejected under 35 U.S.C. 101 because it is drawn to non-statutory subject matter. Applicant recites part of a human, i.e. “…an electrode group for detecting the wearer’s biosignal each disposed on the wearers body surface area with reference to a joint…” (Claim 1, lines 12-13), “…a terminal group for applying physical stimulation to a body surface of a paralysis site each disposed at the paralysis suite centered around dorsiflexor muscles and plantar flexor muscles of the wearer’s ankle …” (Claim 1, lines 15-17). “sound collecting microphone which is provided to the shoe on a side where the wearer's ankle has a paralysis site” (claim 3 lines3-4), “vibration detection part which is provided to the shoe on a side where the wearer's ankle has a paralysis site (claim 4 lines 3-4). Thus, these claims include a human within the scope and are non-statutory.
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970). The examiner suggests using the phrase "adapted to be disposed" when referring to the location of the claimed electrode/ terminal group in relation to the wearer’s body and “adapted to be worn” when referring to the location of the shoe in relation to the wearer’s ankle.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 4-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Edgerton et al (U.S. Patent Application Publication Number: US 2014/0163640 A1, hereinafter “Edgerton” – APPLICANT CITED) in view of Sankai (U.S. Patent Application Publication Number: US 2014/0058299 A1, hereinafter “Sankai”).
Regarding claims 1 and 5, a walking support device and method (e.g. [0003],[0009][0011]: the training device may include a treadmill and a weight-bearing device configured to support at least a portion of the patient's body weight when the patient is positioned to use the treadmill, [0060],[0063]:walking, the training device such as a treadmill and a weight-bearing device configured to support at least a portion of the patient's body weight when the patient is positioned to use the treadmill and is configured to assist with physical training (e.g., at least one of standing, stepping), comprising:
a load measurement part which measures a load applied to an underside of the wearer's feet (e.g. [0021],[0041] Fig. 16 shows the load cell readings during stepping and standing);
a center of gravity calculation part which calculates a center of gravity of each of the feet based on a change of each load measured with the load measurement part (e.g. Fig. 15, [0040]);
a foot motion detection part that detects an acceleration and/or an angular rate during movement of the foot (e.g. [0055]-[0057], [0093], [0041] Fig. 16 shows foot motion readings during stepping and standing);
a gait recognition part which recognizes the wearer's gait based on the calculated center of gravity and movement locus of each of the feet (e.g. [0027]);
a biosignal detection part which has an electrode group for detecting the wearer's biosignal each disposed on the wearer's body surface area with reference to a joint associated with the wearer's walking motion (e.g. [0071], [0127], Fig. 16shows EMG detection);
a stimulation application part which has a terminal group (i.e. electrode array) for applying physical stimulation to a body surface of a paralysis site each disposed at the paralysis site centered around dorsiflexor muscles and plantar flexor muscles of the wearer's ankle (e.g. [0023],[0024] [0079]: electrode arrays applied to tissue corresponding to paralysis site, Note: the claim is ddircetd to an apparatus and just requires electrode arrays that are used to apply stimulation at a body surface of a paralysis site);
a voluntary control part which voluntarily controls the stimulation application part so as to generate stimulating power according to the wearer's intention based on the biosignal detected by the biosignal detection part (e.g. [0042],[0061]);
an autonomous control part which autonomously controls the stimulation application part so as to cause the ankle to dorsiflex or plantarflex based on contraction of the dorsiflexor muscles or the plantar flexor muscles of the wearer based on the wearer's walking cycle obtained from a recognition result of the gait recognition part (e.g. [0050],[0107],[0122]); and
an optimal stimulation adjustment part which adjusts the voluntary control by the voluntary control part and the autonomous control by the autonomous control part so that a left/right balance of the wearer's gait recognized by the gait recognition part will fall within a predetermined range (e.g. [0084], [0112]).
Edgerton teaches obtaining load cell readings, EMG and foot motion readings during stepping and standing to adjust voluntary control and autonomous control (e.g. [0118]: EMG, joint angles, footswitch, ground reaction forces and BWS data were collected, [0060]: the objective not to electrically induce a walking pattern or standing pattern of activation, but to enable/facilitate it so that when the subject manipulates their body position the spinal cord can receive proprioceptive information from the legs (or arms) that can be readily recognized by the spinal circuitry. Then, the spinal cord knows whether to step or to stand or to do nothing and this enables the subject to begin stepping) so that the balance of the wearer’s gait is within a predetermined range as discussed above. Edgerton does not specifically teach that the load measuring part is attached to each inner sole part of a pair of left and right shoes of a wearer and a foot motion detection part which is mounted on a predetermined position of each of the shoes and a movement locus calculation part which calculates a movement locus of each of the feet based on each acceleration and/or each angular rate detected by the foot motion detection part.
In a similar field of endeavor, Sankai teaches a walking support device and method (e.g. abstract, Fig.1,2) comprising a control device (e.g. 110 Fig.2) for controlling a user’s movements based on signals obtained from insole sensors (e.g. [0079]-[0081]), measuring foot motion (e.g. [0016],[0045],[0064]) and center of gravity (e.g. 104 Fig.2) and a movement locus detecting unit for determining movement locus of the feet ( i.e. joint angle detecting unit e.g. 103 Fig.2) and recognizing the wearer’s gait based on the calculated center of gravity and movement locus of the feet and a voluntary control unit (e.g. 111 Fig.2) and autonomous control unit 112 Fig.2) that is used determine a drive signal to assist the wearer’s gait training. Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Edgerton to include the insole sensors and above teachings of Sankai and to provide a control of the stimulation signals in Edgerton in order to provide the predictable results of a more customized and effective therapy.
Regarding claims 2 and 6, Edgerton in view of Sankai teaches the claimed invention as discussed above and Edgerton teaches that the stimulation application part adjusts at least one among strength level, pattern and time of applying stimulation to the wearer's paralysis site according to control of the voluntary control part and/or the autonomous control part (e.g. [0079]-[0080]).
Regarding claims 4 and 8, Edgerton in view of Sankai teaches the claimed invention as discussed above and Edgerton teaches collecting footswitch and ground reaction forces data (e.g. [01118]) and adjusting stimulation based on the collected data and therefore they teach a vibration detection part which is provided to the shoe on a side where the wearer's ankle has a paralysis site, and detecting vibration from a floor surface while the wearer is walking, wherein the optimal stimulation adjustment part corrects the hybrid ratio based on the vibration detected with the vibration detection part.
Claims 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Edgerton et al (U.S. Patent Application Publication Number: US 2014/0163640 A1, hereinafter “Edgerton” – APPLICANT CITED) in view of Sankai (U.S. Patent Application Publication Number: US 2014/0058299 A1, hereinafter “Sankai”) and further in view of Takiguchi et al (U.S. Patent Application Publication Number: US 2002/0107649 A1, hereinafter “Takiguchi”).
Regarding claims 3 and 7, Edgerton in view of Sankai teaches the claimed invention as discussed above and that the optimal stimulation adjustment part corrects the hybrid ratio based on the collected data as discussed above, they do not specifically teach that the data includes data from a sound collecting microphone which is provided in the shoe on a side where the wearer's ankle has a paralysis site to collects sound of footsteps of the shoe.
In a similar field of endeavor, Takiguchi teaches that it is well known to use a microphone in a shoe of a user to collect gait sounds generated by the patient during walking for gait analysis (e.g. abstract, [0016]-[0023],[0151]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Edgerton in view of Sankai to include a microphone in the shoe for collecting sounds of the user while walking for gait analysis and use by the controller in order to provide the predictable results of providing more accurate data of the gait of the user.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792