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: “means for” in claim 17.
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 § 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.
Claim(s) 1, 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KR200356700Y1 to Park Dong-soon (hereinafter “Park”)
Regarding claims 1, 6, 8-9, 12, 16-18, 25. Park discloses a system/apparatus/method for application of a stimulation therapy to a patient (para 0021 “portable skin improving mask”, also system/method of using the device), the system comprising: a first set of one or more heat sources (para 0036 “thermal”, para 0058 “film heater 5”), wherein each of the first set of one or more heat sources are configured to apply heat therapy to a first eye of the patient; a first substrate comprising one or more electrodes, wherein each of the one or more electrodes are configured to deliver microcurrent stimulation therapy to the first eye of the patient (para 0036, 0051 “electric stimulation”, para 0058 “conductive electrode plate 4”); and a controller configured to control delivery of the microcurrent stimulation therapy via the one or more electrodes of the first substrate and the heat therapy via the first set of one or more heat sources to the first eye of the patient (para 0031 “switch”).
Regarding claim 6. Park discloses the system of claim 1, wherein each of the first set of one or more heat sources comprises one or more heating elements arranged to deliver heat to different sub-regions around the first eye (FIG. 1, para 0058 “film heater 5”).
Regarding claim 8. Park discloses the system of claim 1, further comprising a reference or ground electrode placed on the patient to complete an electrical circuit for the microcurrent stimulation (para 0051 “, electric current is supplied to the skin by the conductive electrode plate 4 of the inner eye mask pack 2 to give an electric stimulation to the electrode.”; inherently included to complete the circuit and making the device operable).
Regarding claim 9. Park discloses the system of claim 1, wherein the controller is configured to operate each of the first set of one or more heat sources within an upper temperature limit to protect surrounding tissues (para 0045-0048 “the power supply unit P for supplying power to the heating” – any temperature could be considered to be “the upper temperature limit”)
Regarding claim 12. Park discloses the system of claim 1, wherein each of the first set of one or more heat sources is selected from the group consisting of resistive heating elements, infrared LEDs, laser diodes, or any combination thereof (para 0036 “film heater 5” which is a resistive heating element).
Regarding claims 16 and 25. Park discloses the system of claim 1 and claim 18, wherein the system further comprises: a second set of one or more heat sources, each configured to deliver heat therapy to a second eye to the patient (fig. 1); a second substrate comprising one or more electrodes, wherein each of the one or more electrodes are configured to deliver microcurrent stimulation therapy to the second eye of the patient (fig. 1); and a controller configured to control delivery of the microcurrent stimulation therapy via the one or more electrodes of the second substrate and the heat therapy via each of the second set of one or more heat sources to the second eye of the patient (fig. 1).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-5, 11, 14-15, 19-21, 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park in view of US 20180104514 to Gertner et al (hereinafter “Gertner”).
Regarding claim 2. Park discloses the system of claim 1, but fails to disclose further comprising at least one temperature sensor operatively coupled to the controller and configured to measure a temperature at or near the first eye.
Gertner, from a similar field of endeavor teaches having a temperature sensing element (i.e., temperature sensor) to provide closed loop control of the heating based on the temperature (para 0547, etc.). 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 disclosure of Park with the teachings of Gertner to provide the predictable result of controlling the heating of the device based on the temperature.
Regarding claim 3. Park as modified by Gertner renders obvious the system of claim 2, wherein the controller is configured to adjust an operational parameter of each of the first set of one or more heat sources based on feedback from the temperature sensor to maintain a selected temperature threshold in the vicinity of the first eye (Gertner, para 0547).
Regarding claim 19. Park discloses the method of claim 18, but fails to disclose further comprising measuring a temperature at or near the first eye via at least one temperature sensor and adjusting a parameter of each of the first set of one or more heat sources based on feedback from the temperature sensor to maintain a selected temperature threshold.
Gertner, from a similar field of endeavor teaches having a temperature sensing element (i.e., temperature sensor) to provide closed loop control of the heating based on the temperature (para 0547, etc.). 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 disclosure of Park with the teachings of Gertner to provide the predictable result of controlling the heating of the device based on the temperature.
Regarding claims 4 and 20. Park discloses the system of claims 1 and 18, wherein the controller is configured to deliver microcurrent stimulation [] at least part of the heat therapy provided by each of the first set of one or more heat sources (para 0036 “thermal and electric stimulation”). Park fails to explicitly disclose the two operations to be performed concurrently.
Gertner, from a similar field of endeavor teaches having a control box to set at least one of temperature, amplitude, etc., and different controls to be applied [], simultaneously (para 0265, 0473, 0476). 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 disclosure of Park with the teachings of Gertner to provide the predictable result of controlling the operation of the device.
Regarding claim 5. Park discloses the system of claim 1, wherein the controller is configured to [] between at least one period of heat therapy provided by each of the first set of one or more heat sources and at least one period of microcurrent stimulation over multiple cycles (para 0036 “thermal and electric stimulation”). Park fails to explicitly disclose the two operations to be performed alternatively.
Gertner, from a similar field of endeavor teaches having a control box to set at least one of temperature, amplitude, etc., and different controls to be applied independently (para 0265, 0473, 0476). 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 disclosure of Park with the teachings of Gertner to provide the predictable result of controlling the operation of the device.
Regarding claims 10 and 21, Park discloses the system of claims 1 and 18, but fails to disclose wherein the controller is configured to initiate heat therapy at about 37.5 °C and increase a tissue temperature around the first eye to about 42 °C or 43 °C.
Gertner, from a similar field of endeavor teaches having a temperature sensing element (i.e., temperature sensor) to provide closed loop control of the heating based on the temperature, and to maintain a temperature between 40° C. and 47° C. (para 0035, 0547, etc.). 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 disclosure of Park with the teachings of Gertner to provide the predictable result of controlling the heating of the device based on the temperature.
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Regarding claim 11. Park as modified by Gertner renders obvious the system of claim 10 wherein the controller is further configured to ramp the temperature at about 1 °C every 20 seconds until the temperature around the first eye reaches said target range (para 0035). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In other words, it would have been obvious to modify/increase the temperature at a desired rate to provide the predictable result of improving user comfort.
Regarding claims 14 and 23. Park discloses the system of claims 1 and 18, wherein the controller is configured to provide a first period of heat application and a second period of heat application and change the location or activation pattern of each of the first set of one or more heat sources between the first and second periods.
Gertner, from a similar field of endeavor teaches having a control box to set at least one of temperature, amplitude, etc., and different controls to be applied [], simultaneously (para 0265, 0473, 0476). 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 disclosure of Park with the teachings of Gertner to provide the predictable result of controlling the operation of the device.
It is further understood that modifying Park with the teachings of Gertner would render obvious controlling the two sides of the wearable device separately and independently to provide controlling the parameters for each eye based on desired treatment (i.e., first eye vs second eye) separately. See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding claims 15 and 24. Park as modified by Bertner renders obvious the system of claim 14 and 23, wherein the controller is configured to insert a rest period after the first period of heat therapy and before delivering the second period of heat therapy or microcurrent stimulation, thereby creating a sequenced therapy comprising heat, rest, and microcurrent stimulation phases (see rejection of claim 14 and 23 above; it is noted that the claim does not provide any details regarding the specific treatment, length of rest, length of each period, etc., therefore, any controlling and modulation of the parameters would read over the claimed limitations as currently recited.).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park in view of US 20160121118 to Manfred et al. (hereinafter “Manfred”).
Regarding claim 7. Park discloses the system of claim 1, but fails to disclose wherein the microcurrent stimulation delivered by the electrodes on the first substrate is characterized by a frequency between about 1 Hz and about 120 Hz and an amplitude up to about 20 mA.
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 disclosure of Park with the teachings of Gertner to provide the predictable result of using the known frequency to provide treatment.
Park as modified by Bertner renders obvious the limitations above obvious but fails to explicitly disclose the amplitude to be up to about 20 mA.
Manfred, from a similar field of endeavor, shows that it is known to provide treatments at various parameters including 50-80 hz, and amplitudes in the range from .1 to 10 mA. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). 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 disclosure of Park with the teachings of Manfred to provide the predictable result of using the known parameters to provide a desired treatment.
Claim(s) 13 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park in view of US 20060069420 A1 to Rademacher et al. (hereinafter “Rademacher”).
Regarding claims 13 and 22. Park discloses the system of claims 1 and 18, but fails to disclose wherein the heat therapy is delivered for a time duration between about 1 minute and about 30 minutes during at least one treatment session.
Rademacher, from a similar field of endeavor, teaches that it is known for treatment therapy to be about 20 minutes (para 0060). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify the disclosure of Park with the teachings of Rademacher to provide the desired treatment.
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796
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