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 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 – 25 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. With regard to claim 1, the claim is generally directed to a computer program product to cause a computing device to perform “storing” and “determining” steps. As such, it is unclear how the details of measured light intensity measurements or a manner to use a wearable monitor (which is involved in data gathering, but is not part of the claimed computer program product) are intended to materially limit the two positively claimed functions. With regard to claims 12 – 14, it is unclear what aspect of the claimed computer program product is intended when indicating “the model is deployed on…” the various intended devices. With regard to claims 15 and 25, it is unclear how merely “applying” (providing?) data to a model results in “calculating…” a value as indicated by the 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 – 27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
According to Step 1 of the eligibility analysis, the claim(s) are directed to a “computer program product… comprising non-transitory computer executable code embodied in a non-transitory computer readable medium”, a “method” and a “system” which are each within a statutory category of invention.
According to Revised Step 2A, Prong One of the eligibility analysis, the claims recite(s) details of a mental step of “storing a model that associates a ratio” of values and mathematical processing: “determining… by applying… to the model…” (which refers to specific mathematical relationships as part of the model, consistent with the details of the “storing” step) and thus recite abstract ideas. According to Revised Step 2A, Prong Two of the eligibility analysis, these judicial exceptions (abstract ideas: mathematical concepts, mental process) are not integrated into a practical application because the claims only provide details drawn to generic processing aspects beyond the judicial exception, as the claims merely require the processor to be provided the necessary data to apply to the model. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as indicated, the additional elements relate to nominally recited sensors to acquire the light intensity measurements, but does not serve to meaningfully limit the manner in which a processor acts to apply the model to data. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as indicated, any additional elements in the claims are merely recited in a generalized/high level manner or do not positively limit the claim scope.
Further, no details in any dependent claim are sufficient to show integration of the judicial exception, nor do any of those claims recite details that are considered to amount to significantly more under the eligibility analysis Step 2B, since they merely recite aspects of the judicial exception and/or mere generalized details.
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.
Claim(s) 1, 12, 15 – 18, and 23 – 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cho et al. (EP 1886624 - cited by Applicant). Cho et al. teach a computer program product, and associated method and system, for characterizing dermis thickness (Fig. 17) comprising non-transitory computer executable code embodied in a non-transitory computer readable medium that, when executing on one or more computing devices, causes the one or more computing devices to perform the steps of: ([0092] Controller (250) (computing device), drives detection system, controlling the light sources and photodetectors, and performs skin tissue thickness calculations); storing a model that associates a ratio of at least two light intensity measurements with a thickness of a dermal layer in a multi-layer human tissue, wherein: ([0091] a look-up table (model) is stored in the memory, associating two light intensity measurements with a thickness of a dermal layer on the wrist of the subject (multilayer tissue); each of the at least two light intensity measurements is obtained at one or more predetermined wavelengths, [0085-86]). In use, light is emitted at predetermined wavelengths (eg. 660nm and 940nm) each of the at least two light intensity measurements is obtained from a surface of the multi-layer human tissue, ([0092] At least two intensities are measured sequentially from the light emitted towards the skin of the user), as seen in fig.17) and at least two of the at least two light intensity measurements are obtained at different predetermined distances along the surface of the multi-layer human tissue from a light source directed into the dermal layer ([0082] As seen in fig.17, the two light detectors (210a, 210b) are spaced apart by predetermined distances along the surface of the user's skin surface and capture light coming from a light source (220b, 230b) illuminating the skin of the user) with a wearable physiological monitor ([0056] Device is a wearable device that can monitor physiological signals (optical signals related to the thickness and color of the patient’s skin), emitting light at the one or more predetermined wavelengths toward the skin of a user; measuring a first intensity of light at the one or more predetermined wavelengths with a first sensor; measuring a second intensity of light at the one or more predetermined wavelengths with a second sensor; and ([0085-86] Light is emitted at predetermined wavelengths (e.g. 660nm and 940nm); [0092] At least two intensities are measured sequentially from the light emitted towards the skin of the user) determining a dermal thickness of a dermal layer of the user by applying the first intensity and the second intensity to the model ([0091] The dermal thickness is estimated by inputting the first and second detected light intensities to a look-up table (model)). Therefore, Cho et al. disclose the subject matter of claim 1. Similarly, Cho et al. teach a corresponding method comprising: providing a model that associates at least two light intensity measurements with a thickness of a layer in a multi-layer tissue, wherein the at least two light intensity measurements are (a) at a predetermined range of wavelengths and (b) at two or more predetermined distances along a surface of the multi-layer tissue; directing illumination within the predetermined range of wavelengths into a skin of a user; ([0091-92]) and the dermal thickness is estimated by inputting the detected light intensities of the first and second detector (210a, 210b) to a look-up table (model) [0085-86]. The light sources are emitting infrared or near-infrared light towards the skin of the user as shown in Figure 17 detailing obtaining a plurality of light measurements by measuring an intensity of light within the predetermined range of wavelengths at the two or more predetermined distances along the surface of the skin of the user; and [0082] As seen in fig.17, the two light detectors (210a, 210b) are spaced apart by predetermined distances along the surface of the user's skin surface and capture light coming from a light source (220b or 230b) illuminating the skin of the user. Cho et al. further teach calculating layer thickness of a layer of a tissue of the user by applying the plurality of light measurements to the model [0091-92].
The features of claim 25 are present in Cho et al., consistent with the details discussed above.
Further, with regard to dependent claims 12, 26, and 27, the model is deployed on the wearable device and the wearables controller performs the calculations and is configured to display the results thereof. As discussed above and consistent with the details of dependent claims 16 and 17, Cho et al. as seen in Fig.17 provide the light emitted by two light sources (220b, 230b) is detected by two optical sensors (210a, 210b) on different locations along the surface of the skin (276) of the user. Likewise, the details of dependent claims 18, 23, and 24 are provided by Cho et al. in that the controller (250) determines the thickness of a dermal layer or a fat layer based on the look-up table stored in the memory of the system.
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) 2 – 11, 13, 14, and 19 – 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. as applied to claims 1, 12, 15 – 18, and 23 – 27 above.
With regard to claims 2, 3, and 19, Cho et al. teach details of measurements of dermal thickness as discussed above but do not particularly indicate repeating steps for following a progression over time, however computing changes in a medical condition over time is well known for assisting a medical professional in monitoring progression of the condition for implementing/updating treatments. As such, without a showing of unexpected results or criticality it would have been within the skill level of the art before the effective filing date to have modified Cho et al. to use repeating detection steps over time to capture the trend of a physiological parameter, consistent with well-known practices in the art.
While Cho et al. do not particularly indicate use of communication of data for remote processing, as set forth in claims 13 and 14, this was a standard technique in the art before the effective filing date of the claimed invention and would have been within the skill level of the art to implement in the invention of Cho et al. consistent with known practices.
Similarly, while Cho et al. rely upon a look-up table in determining the dermal thickness from the measurement results, they do not disclose how the look up table used to associate intensity measurements with tissue thickness is calculated. However, use of empirical, statistical, mathematical methods or Monte-Carlo simulations (as recited in claims 4 – 6) are well known techniques in the art and the choice of one or the other, since not associated with any unexpected advantages in the description, is considered an obvious manner to provide the required look-up table. Additionally, as the structure of skin is known to include plural layers, it would have been within the skill level of the art to implement Cho et al. to collect data and use analysis techniques to produce output information to characterize the plural layers.
Regarding claim 8, Cho et al. disclose a wearable measurement device as discussed above, but do not particularly indicate that skin elasticity is assessed based on measuring response to a mechanical vibration. However, portable systems that measure skin elasticity using mechanical vibrations are known in the art, and it would be obvious to one of skill in the art to modify Cho et al. to use mechanical vibrations to measure skin elasticity consistent with known practice, since this provides further information on the subject’s skin health. Additionally, claims 9 and 10, like claims 2 and 3, are merely directed to use of known techniques to collect and analyze elasticity information over time. Further, regarding claim 11, since the correlation between skin elasticity and hydration is well known, modifying Cho et al. to rely on this known relationship in assessing changes in hydration levels would be an obvious modification, to provide the user with information of known medical relevance.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Xu (USPGPub 2023/0133936) teaches a wearable optical measurement arrangement in which a variety of emitter-detector distances are measured (Figures 2-6, for example).
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
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