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 .
Election/Restrictions
Applicant’s election without traverse of Invention 1, Claims 1-13, in the reply filed on 04/13/2026 is acknowledged.
Claims 14-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/13/2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 1-13 are currently under examination.
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:
Claim 1: The claim limitation “a stimulus generator device positioned within the housing and being operable to generate a stimulus based on a set of predetermined stimulation parameters” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “generator device” coupled with functional language “operable to generate a stimulus based on a set of predetermined stimulation parameters” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “generator device”.
Claim 1: The claim limitation “first stimulus element being operable to apply the stimulus to the digit.” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “element” coupled with functional language “operable to apply the stimulus to the digit.” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “element”.
Claim 4: The claim limitation “a biasing element that biases the first body portion and the second body portion towards the first closed configuration and generates the clamping force applied to the digit when the first body portion and the second body portion are in the second open configuration” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “element” coupled with functional language “biases the first body portion and the second body portion towards the first closed configuration and generates the clamping force applied to the digit when the first body portion and the second body portion are in the second open configuration” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “element”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
A laser generator, a waveform generator, force generator or equivalents thereof, as described on Par. 48 and 51 of the disclosure filed on 01/04/2024,
An electrode, laser portal, force applicator, or equivalents thereof, as described on Par. 51, Par. 75, and Par. 90 of the disclosure filed on 01/04/2024,
A biasing element or equivalents thereof, as described on Par. 36 of the disclosure filed on 01/04/2024, which lacks sufficient detail as to the structure that performs the indicated function, and will be interpreted as any structure capable of the indicated function.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/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.
Claim 4 is 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.
Claim 4 recites the limitation “wherein the housing includes a biasing element that biases the first body portion and the second body portion towards the first closed configuration and generates the clamping force applied to the digit when the first body portion and the second body portion are in the second open configuration”, where the applicant’s specification lacks sufficient detail regarding the “biasing element” that accomplishes the indicated function “that biases the first body portion and the second body portion towards the first closed configuration and generates the clamping force applied to the digit when the first body portion and the second body portion are in the second open configuration”. The corresponding structure within the applicant’s specification is indicated as “a biasing element 109 and a hinge 110 such that the first body portion 106 and the second body portion 107 collectively form a clamp or clip mechanism” (Par. 36 of applicant’s spec.) and “clamping force generated by the biasing element 109 is applied at the digit 10” (Par. 53 of applicant’s spec.). However, this merely reiterates the term “biasing element” without indicating what the element itself is, where a term cannot be defined by itself. As such, the claim is rejected.
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 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “wherein the first body portion and the second body portion collectively apply a clamping force to the digit” which reads as a method step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. (MPEP 2173.05 (p) citing In Re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011)). For examination purposes, this will be interpreted as the first body portion and the second body portion being capable of applying a clamping force to the digit.
Claim 4 limitation “wherein the housing includes a biasing element that biases the first body portion and the second body portion towards the first closed configuration and generates the clamping force applied to the digit when the first body portion and the second body portion are in the second open configuration” 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 corresponding structure within the applicant’s specification is indicated as “a biasing element 109 and a hinge 110 such that the first body portion 106 and the second body portion 107 collectively form a clamp or clip mechanism” (Par. 36 of applicant’s spec.) and “clamping force generated by the biasing element 109 is applied at the digit 10” (Par. 53 of applicant’s spec.). However, this merely reiterates the term “biasing element” without indicating what the element itself is, as a term cannot be defined by itself. For example, is it an elastic band or spring? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as any structure capable of the indicated function.
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.
Clams 2-13 are dependent on claim 1, and as such are also rejected.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The claims are generally directed towards a device with a first and second body portion that define a receptacle configured to capture a digit of a patient. The device comprises a stimulus generator device within the housing and a first stimulus element operable to apply a stimulus to the digit.
Claim(s) 1-4 and 7-8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yamanaka (US Pub. No. 20160022214) hereinafter Yamanaka.
Regarding claim 1, Yamanaka discloses A device (Fig. 1, 3A, (Fingertip unit 1 and measuring device 110)), comprising:
a housing (Fig. 1, 3A, (Fingertip unit 1 and measuring device 110)) defining a first body portion (Fig. 1, interposing portion – 11) and a second body portion (Fig. 1, placing portion – 12) (Fig. 1 (observable that interposing portion 11 and placing portion 12 define a receptacle for finger A as seen in Fig. 1b)), the first body portion and the second body portion collectively defining a receptacle (Fig. 1 (observable that interposing portion 11 and placing portion 12 define a receptacle for finger A as seen in Fig. 1b));
wherein the receptacle is configured to capture a digit of a patient therein (Fig. 1 (observable that interposing portion 11 and placing portion 12 define a receptacle for finger A as seen in Fig. 1b)); and
wherein the first body portion and the second body portion collectively apply a clamping force to the digit (Fig. 1b (observable finger between interposing region 11 and placing portion 12))(Par. 80, “the fingertip measuring unit 1 has a so-called clip structure…” “…Hereby, the relative positional relationship between the fingertip portion A and the measuring portion 14 is fixed. In other words, the fingertip portion A is fixed in the state of being pressed against the measuring face 143 of the measuring portion 14 and the placing face 17.”);
a stimulus generator device positioned within the housing (Fig. 2, light source -111 (light source 111 inside the measuring device 110 that is part of the above indicated housing)) and being operable to generate a stimulus based on a set of predetermined stimulation parameters (Par. 64-65 (light source generates excitation light based on predetermined wavelength parameters)); and
a first stimulus element (Fig. 1, measuring portion – 14) in communication with the stimulus generator device (Par. 73, “As illustrated in FIG. 4, the measuring probe 113 is an incidence-emission coaxial system optical fiber, and includes a fiber for incidence 114 that guides the excitation light from the light source 111…” “…Moreover, the other end portion is separated into the fiber for incidence 114 and the fiber for emission 115, and the fiber for incidence 114 is connected to the light source 111, and the fiber for emission 115 is connected to the detector 112”) (Par. 83, “The measuring portion 14 is an end portion (measurement attachment) of the side where the fiber for incidence 114 and the fiber for emission 115 of the measuring probe 113 described above are integrated. That is, the measuring portion 14 is a portion where the functions of the emitting portion which emits the excitation light and the light-receiving portion which receives the fluorescence are integrated…”) and positioned along the receptacle (Fig. 1 (observable that measuring portion 14 is positioned along the above indicated receptacle)) (Par. 83, (measuring portion 14 emits the excitation light)), the first stimulus element being operable to apply the stimulus to the digit (Par. 83, “the measuring portion 14 is a portion where the functions of the emitting portion which emits the excitation light and the light-receiving portion which receives the fluorescence are integrated…” “…measuring portion 14 may irradiate the contact fingertip portion A with the excitation light, and may receive the fluorescence from the fluorescent materials (AGEs) which are present in the blood vessel within the fingertip portion A.”).
Regarding claim 2, Yamanaka further discloses wherein the first body portion and the second body portion are operable to collectively assume a first closed configuration (Fig. 1A (position of interposing portion 11 and placing portion 12 in Fig. 1A)) and a second open configuration (Fig. 1B (position of interposing portion 11 and placing portion 12 in Fig. 1B)).
Regarding claim 3, Yamanaka further discloses wherein the stimulus generator device (Par. 64, “The light source 111 is a light source that generates the excitation light with which the fingertip portion A is irradiated…”) is operable to apply the stimulus to a surface of the digit through the first stimulus element when the first body portion and the second body portion are in the second open configuration (Fig. 1B (position of interposing portion 11 and placing portion 12 in Fig. 1B)) (Par. 83, “the measuring portion 14 is a portion where the functions of the emitting portion which emits the excitation light and the light-receiving portion which receives the fluorescence are integrated…” “…measuring portion 14 may irradiate the contact fingertip portion A with the excitation light, and may receive the fluorescence from the fluorescent materials (AGEs) which are present in the blood vessel within the fingertip portion A.”).
Regarding claim 4, Yamanaka further discloses wherein the housing includes a biasing element (Par. 80, fixing force supply portion – 13) that biases the first body portion and the second body portion towards the first closed configuration and generates the clamping force applied to the digit when the first body portion and the second body portion are in the second open configuration (Par. 80, “The fixing force supply portion 13 is a member that supplies the force which is capable of fixing a relative positional relationship between the measurement target region and the measuring portion 14 to the measurement target region through the interposing portion 11. The fixing force supply portion 13 of Embodiment 1 is a spring type hinge…”).
Regarding claim 7, Yamanaka further discloses wherein the stimulus generator device includes a laser generator that generates a laser having an output wavelength according to the set of predetermined stimulation parameters (Fig. 2, light source -111 (light source 111 inside the measuring device 110 that is part of the above indicated housing)) (Par. 64-65 (light source generates excitation light source based on predetermined wavelength parameters)), wherein the stimulus is a thermal stimulus generating a stimulating temperature along a surface of the digit and wherein the stimulus is resultant of the laser having the output wavelength (Fig. 2, light source -111 (light source 111 inside the measuring device 110 that is part of the above indicated housing)) (Par. 64-65 (light source generates excitation light source based on predetermined wavelength parameters and is able to generate heat)).
Regarding claim 8, Yamanaka further discloses wherein the first stimulus element is a laser portal that applies the stimulus to a predefined area along the digit corresponding with a diameter of the laser (Par. 83, “the measuring portion 14 is a portion where the functions of the emitting portion which emits the excitation light and the light-receiving portion which receives the fluorescence are integrated…” “…measuring portion 14 may irradiate the contact fingertip portion A with the excitation light, and may receive the fluorescence from the fluorescent materials (AGEs) which are present in the blood vessel within the fingertip portion A.” (the irradiated contact portion A irradiated corresponds to the provided light from measuring portion 14)).
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.
Claim(s) 5, 10, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamanaka as applied to claim 1 above, and further in view of (US Pub. No. 20130245491) hereinafter Nikzad.
Yamanaka discloses the device of claim 1 above.
Regarding claim 5, Yamanaka fails to explicitly disclose the limitations of the claim.
However, Nikzad teaches wherein the stimulus generator device includes a waveform generator and wherein the stimulus is an electrical stimulus generated by the waveform generator having a voltage output value and/or a current output value according to the set of predetermined stimulation parameters (Par. 20, “diagnostic tip 208 may be coupled to an electrical voltage and/or current source, such as a chargeable capacitor housed within the diagnostic head 204 or handle 202, to furnish, upon the activation of the diagnostic tip, a measured electrical charge to the patient's finger to test the patient's sensitivity to such stimuli. In some embodiments, the capacitor may be charged to a fixed and predetermined level, while in other embodiments, the charge of the capacitor may be programmable and/or adjustable.”) and a variety of stimuli (Par. 9, “patient's skin sensitivity to a variety of stimuli and conditions such as heat or temperature, vibrations, electrical shock, pressure, pain, burning sensation, and the like…”).
Yamanaka and Nikzad are considered to be analogous art to the claimed invention as they are involved with measured responses to stimuli.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamanaka with that of Nikzad to include wherein the stimulus generator device includes a waveform generator and wherein the stimulus is an electrical stimulus generated by the waveform generator having a voltage output value and/or a current output value according to the set of predetermined stimulation parameters through the substitution of stimuli as different stimuli are known in the art (Nikzad (Par. 9, “patient's skin sensitivity to a variety of stimuli and conditions such as heat or temperature, vibrations, electrical shock, pressure, pain, burning sensation, and the like…”)) and it would have yielded the predictable result of assessing the users sensitivity to an electrical stimulus (Nikzad (Par. 20)).
Regarding claim 10, Yamanaka fails to explicitly disclose the limitations of the claim.
Yamanaka does teach in an alternate embodiment an additional sensor (Fig. 13, load sensor – 222).
However, Nikzad teaches wherein the first body portion includes a distal-most surface (Fig. 2 (surface of tip -208)), the distal-most surface including a second stimulus element in communication with the stimulus generator device (Par. 20, “In some embodiments, diagnostic tip 208 may be coupled to an electrical voltage and/or current source, such as a chargeable capacitor housed within the diagnostic head 204 or handle 202…”) and a variety of stimuli (Par. 9, “patient's skin sensitivity to a variety of stimuli and conditions such as heat or temperature, vibrations, electrical shock, pressure, pain, burning sensation, and the like…”) (Par. 16, “diagnostic tip 208 may be configured to perform one or more testing functions including thermal (hot and cold), pressure, pain, electrical shock, burning, and other similar sensations.”)
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamanaka with that of Nikzad to include wherein the first body portion includes a distal-most surface, the distal-most surface including a second stimulus element in communication with the stimulus generator device through the combination of references as differing stimuli are known in the art (Nikzad (Par. 9)) and it would have yielded the predictable result of assessing the users sensitivity to additional stimuli (Nikzad (Par. 16)).
Regarding claim 11, Yamanaka fails to explicitly disclose the limitations of the claim.
Yamanaka does teach in an alternate embodiment an additional sensor (Fig. 13, load sensor – 222).
However, Nikzad further teaches wherein the stimulus generator device is operable to apply the stimulus to a surface of the patient through the second stimulus element when the first body portion and the second body portion are in a first closed configuration (Par. 20, “In some embodiments, diagnostic tip 208 may be coupled to an electrical voltage and/or current source, such as a chargeable capacitor housed within the diagnostic head 204 or handle 202…”) (Par. 16, “diagnostic tip 208 may be configured to perform one or more testing functions including thermal (hot and cold), pressure, pain, electrical shock, burning, and other similar sensations.”) (Fig. 2 (operable to apply the stimulus in the closed configuration of Fig. 2)) and a variety of stimuli (Par. 9, “patient's skin sensitivity to a variety of stimuli and conditions such as heat or temperature, vibrations, electrical shock, pressure, pain, burning sensation, and the like…”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamanaka and Nikzad with that of Nikzad to include wherein the stimulus generator device is operable to apply the stimulus to a surface of the patient through the second stimulus element when the first body portion and the second body portion are in a first closed configuration through the combination of references as differing stimuli are known in the art (Nikzad (Par. 9)) and it would have yielded the predictable result of assessing the users sensitivity to additional stimuli (Nikzad (Par. 16)).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamanaka in view of Nikzad as applied to claim 5 above, and further in view of Lee (US Pub. No. 20180318582) hereinafter Lee.
Yamanaka and Nikzad teach the device of claim 5 above.
Regarding claim 6, modified Yamanaka fails to explicitly disclose the limitations of the claim.
However, Nikzad does teach the stimulus to a predefined area along a surface of the digit corresponding with the effective surface area (Par. 20, “diagnostic tip 208 may be coupled to an electrical voltage and/or current source, such as a chargeable capacitor housed within the diagnostic head 204 or handle 202, to furnish, upon the activation of the diagnostic tip, a measured electrical charge to the patient's finger to test the patient's sensitivity to such stimuli. In some embodiments, the capacitor may be charged to a fixed and predetermined level, while in other embodiments, the charge of the capacitor may be programmable and/or adjustable.”) and a variety of stimuli (Par. 9, “patient's skin sensitivity to a variety of stimuli and conditions such as heat or temperature, vibrations, electrical shock, pressure, pain, burning sensation, and the like…”).
However, Lee teaches wherein the first stimulus element is an electrode having an effective surface area that applies the stimulus to a predefined area along a surface corresponding with the effective surface area (Par. 39, “Stimulation electrodes 322, 324 may extend outward from the bottom housing section 328, so as to positively contact a patient's skin when the wrist unit 320 is in place. One or more cables 326 may connect the stimulation unit 320 to a base unit (e.g., 110 in FIG. 1). In some implementations, the pair of stimulation electrodes on the wrist unit delivers electrical energy (“stimulus”) to cause “arousal” state by delivering safe low dosage in the form of milliamp current in certain frequency pulses.”) (Par. 35, “In various implementations, the wrist unit may take any suitable form, and may cover a larger or smaller portion of a patient's hand, arm, and/or wrist.”).
Yamanaka, Nikzad, and Lee are considered to be analogous art to the claimed invention as they are involved with measured responses to stimuli.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamanaka and Nikzad with that of Lee to include wherein the first stimulus element is an electrode having an effective surface area that applies the stimulus to a predefined area along a surface of the digit of Yamanaka corresponding with the effective surface area for the reasoning as indicated in claim 5 above, and through the combination of references as it would have yielded the predictable result of providing the exact structure needed to provide the electrical stimulus of Nikzad.
Claim(s) 9 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamanaka as applied to claim 1 above, and further in view of Harte (US Pub. No. 20110082384) hereinafter Harte.
Yamanaka discloses the device of claim 1 above.
Regarding claim 9, Yamanaka fails to explicitly disclose the limitations of the claim.
However, Harte teaches wherein the housing is portable (Par. 81, “a portable device for determining a subject's pain level at the thumbnail or other areas (e.g. head, face, legs). Also, additional or alternative stimulators can be used to measure or gauge a subjects response to non pressure/strain stimuli (e.g. visual, olfactory, heat). In certain embodiments, the portable device is a hand-held apparatus; most preferably the apparatus employs an automated pressure member to deliver a blunt force stimulus to the subject's thumbnail bed.…”) and wherein the first body portion and/or the second body portion include a gripping portion (Par. 58, “With additional reference to FIG. 4, the thumb stimulator 26 is illustrated in use and as grasped around the main body 60 by a hand 90 of the patient or test subject.”) (Par. 48, “. The hand piece module 60 is ergonomically designed to be held comfortably in either the left or right hand and maintain a thumb of a patient in a consistent position for testing, in a thumbhole 62.”).
Yamanaka and Harte are considered to be analogous art to the claimed invention as they are involved with measured responses to stimuli.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamanaka with that of Harte to include wherein the housing is portable and wherein the first body portion and/or the second body portion include a gripping portion through the combination of references as it would have yielded the predictable result of making the device portable, improving flexibility in the use of the device, and improving the user’s ability to grasp the device (Harte (Par. 48)).
Regarding claim 13, Yamanaka fails to explicitly disclose the limitations of the claim.
However, Harte teaches further comprising an activation switch operable for assuming a first activation state and a second activation state (Par. 53, “Other control buttons 82, such as a start button or onset of pain input button, can be provided for subject input on the handle 60. In various embodiments, the buttons or other subject inputs directly on the handle 60 can be the subject input 24. The control processor 74 can include a start of stimulus command and an end stimulus command based upon the algorithm applied or to remove pressure in case a link with the central processor 20 is lost. Also, force, strain, and time safety thresholds can be included, which can, at the start of each stimulus, be automatically set slightly above the desired stimulus parameters. Should excessive force be measured for any reason, or the test continue for longer than expected, or minimum compressed thumb thickness is detected the current stimulus can terminated and the transducer 34 can be immediately removed from the subject.”) (Fig. 4, control buttons -82) , wherein the activation switch is operable for activating the stimulus generator device when in the first activation state and wherein the activation switch is operable for deactivating the stimulus generator device when in the second activation state (Par. 53, “Other control buttons 82, such as a start button or onset of pain input button, can be provided for subject input on the handle 60. In various embodiments, the buttons or other subject inputs directly on the handle 60 can be the subject input 24. The control processor 74 can include a start of stimulus command and an end stimulus command based upon the algorithm applied or to remove pressure in case a link with the central processor 20 is lost. Also, force, strain, and time safety thresholds can be included, which can, at the start of each stimulus, be automatically set slightly above the desired stimulus parameters. Should excessive force be measured for any reason, or the test continue for longer than expected, or minimum compressed thumb thickness is detected the current stimulus can terminated and the transducer 34 can be immediately removed from the subject.”) (Fig. 4, control buttons -82).
Yamanaka and Harte are considered to be analogous art to the claimed invention as they are involved with measured responses to stimuli.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamanaka with that of Harte to include further comprising an activation switch operable for assuming a first activation state and a second activation state, wherein the activation switch is operable for activating the stimulus generator device when in the first activation state and wherein the activation switch is operable for deactivating the stimulus generator device when in the second activation state through the combination of references as it would have yielded the predictable result of providing the user with the ability to manually start and stop the device (Harte (Par. 53)) conserving power and directly controlling the stimulus.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamanaka in view of Nikzad as applied to claim 11 above, and further in view of Bijelic (US Pub. No. 20080027507) hereinafter Bijelic.
Yamanaka discloses the device of claim 11 above.
Regarding claim 12 modified Yamanaka fails to explicitly disclose the limitations of the claim.
Yamanaka does teach in an alternate embodiment a position switch (Par. 113, 121-122 (load sensor -222 and load control portion -223 that determines force applied to finger)).
However, Nikzad further teaches the stimulus to a predefined area along a surface of the digit corresponding with the effective surface area (Par. 20, “diagnostic tip 208 may be coupled to an electrical voltage and/or current source, such as a chargeable capacitor housed within the diagnostic head 204 or handle 202, to furnish, upon the activation of the diagnostic tip, a measured electrical charge to the patient's finger to test the patient's sensitivity to such stimuli. In some embodiments, the capacitor may be charged to a fixed and predetermined level, while in other embodiments, the charge of the capacitor may be programmable and/or adjustable.”) and a variety of stimuli (Par. 9, “patient's skin sensitivity to a variety of stimuli and conditions such as heat or temperature, vibrations, electrical shock, pressure, pain, burning sensation, and the like…”).
Bijelic teaches a position switch positioned along the first body portion (Par. 16, “switch means may be carried by the substrate.”) (Par. 6, “a nerve stimulation array electrode comprising a substrate for application to the skin of a user bearing an array of electrodes arranged to be brought into electrical contact with the skin of a user when the substrate is positioned on said skin”) and configured to assume a first position state when the first body portion and the second body portion are in the first closed configuration and configured to assume a second position state when the first body portion and the second body portion are in a second open configuration (Par. 17-19, “Optionally, the switch means comprises…” “…a said electronic switching unit adapted to receive said data signals and to perform connection of selected electrodes…”) (Par. 20, “Said electronic user interface unit may be adapted to accept programming to alter said selection of electrodes to accommodate said selection to alterations in the desired site of stimulation with time or user muscle movement…”)(Examiner's Note: The switch is capable of the indicated function);
wherein the position switch causes the second stimulus element to apply the stimulus when the position switch is in the first position state (Par. 17-19, “Optionally, the switch means comprises…” “…a said electronic switching unit adapted to receive said data signals and to perform connection of selected electrodes…”) (Par. 20, “Said electronic user interface unit may be adapted to accept programming to alter said selection of electrodes to accommodate said selection to alterations in the desired site of stimulation with time or user muscle movement…”); and
wherein the position switch causes the first stimulus element to apply the stimulus when the position switch is in the second position state (Par. 17-19, “Optionally, the switch means comprises…” “…a said electronic switching unit adapted to receive said data signals and to perform connection of selected electrodes…”) (Par. 20, “Said electronic user interface unit may be adapted to accept programming to alter said selection of electrodes to accommodate said selection to alterations in the desired site of stimulation with time or user muscle movement…”).
Yamanaka, Nikzad, and Bijelic are considered to be analogous art to the claimed invention as they are involved with response to stimuli.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Yamanaka and Nikzad with that of Bijelic to include a position switch positioned along the first body portion of Yamanaka and configured to assume a first position state when the first body portion and the second body portion are in the first closed configuration of Yamanaka and configured to assume a second position state when the first body portion and the second body portion are in a second open configuration of Yamanaka; wherein the position switch causes the second stimulus element of Nikzad to apply the stimulus when the position switch is in the first position state of Yamanaka; and wherein the position switch causes the first stimulus element of Yamanaka to apply the stimulus when the position switch is in the second position state of Yamanaka through the combination of references as it would have yielded the predictable result of allowing for precise and optimized stimulation depending on the users body (Bijelic (Par. 20)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ARI S PADDA/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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