DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. According to the Amendment, filed 15 May 2024, the status of the claims is as follows:
Claims 35-57 are new; and
Claims 1-34 are cancelled.
Claim Objections
3. Claim 35 is objected to because of the following informalities:
In line 2, “on skin” is a typographical/grammatical error and should be amended to “on a skin”;
In line 15, “the area” lacks proper antecedent basis as area was previously defined, and should be amended to “an area”; and
In lines 10, 15, 17, and 19, the instances of “skin” lack proper antecedent basis and should be amended to “the skin”.
Appropriate correction is required.
4. Claim 35 is objected to because of the following informalities:
In lines 10, 14, 16, 19, and 20, “the collected photons” lacks proper antecedent basis as there is no description of collecting photons, and should be amended to “thedetected photons” (see step (c) for support of proposed amendment).
Appropriate correction is required.
5. Claim 35 is objected to because of the following informalities:
In line 2, “the end surface of the device” lacks proper antecedent basis as the end surface was previously defined, and should be amended to “ comprising an end surface, the end surface”.
Appropriate correction is required.
6. Claim 35 is objected to because of the following informalities:
In line 20, “the presence and absence of applied transient force” lacks proper antecedent basis as the presence and absence of applied transient force was previously defined, and should be amended to “a presence and absence of applied transient force”.
Appropriate correction is required.
7. Claims 38-40, 42, and 44 are objected to because of the following informalities:
In the claims, the occurrences of “emitters” lack proper antecedent basis, and should be amended to “photonic emitters”.
Appropriate correction is required.
8. Claim 44 is objected to because of the following informalities:
In line 2, “different wavelength” is a typographical/grammatical error, and should be amended to “different wavelengths”; and
In lines 2-3, “scattering spectrum” is a typographical/grammatical error, and should be amended to “a scattering spectrum”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
9. 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.
10. Claims 35-57 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more.
Step 1 of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.03):
Claims 35-57 are directed to a “method”, which describes one of the four statutory categories of patentable subject matter, i.e. a process.
Step 2A of the Revised Patent Subject Matter Eligibility Guidance (see MPEP 2106.04):
Claim(s) 35-57 recite the following mental process:
…
(g) comparing dynamic changes in the scattering profile of the collected photons from the lesion on skin of the subject in response to the applied transient force; and
(h) outputting a biological state of the subject based at least in part on the comparison of the scattering profile of the collected photons from the lesion on skin of the subject with the scattering profile of the collected photons in the presence and absence of applied transient force.
This judicial exception is not integrated into a practical application because the additional limitations of “(a) applying a device to a lesion on skin of the subject, the end surface of the device comprising a photonic emitter and a photonic sensor, the photonic emitter and photonic sensor placed a predetermined distance from each other; (b) emitting, from the device, photons from the photonic emitter having at least one wavelength onto the skin of the subject, wherein the photons scatter from subcellular structures of the skin differently based on a wavelength of the photon; (c) detecting, by the device, photons with the photonic sensor that are scattered from the skin of the subject; (d) creating a scattering profile of the collected photons from the lesion on skin of the subject; (e) applying a transient force to the lesion on the skin of the subject through the end surface of the device; (f) repeating steps (a) through (e) to create a scattering profile of the collected photons from the area of skin of the subject to the applied transient force;” in claim 35 add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process.
Step 2B of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.05):
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, when considered separately and in combination.
Analyzing the additional claim limitations individually, the additional limitations that are not directed to the mental process are “(a) applying a device to a lesion on skin of the subject, the end surface of the device comprising a photonic emitter and a photonic sensor, the photonic emitter and photonic sensor placed a predetermined distance from each other; (b) emitting, from the device, photons from the photonic emitter having at least one wavelength onto the skin of the subject, wherein the photons scatter from subcellular structures of the skin differently based on a wavelength of the photon; (c) detecting, by the device, photons with the photonic sensor that are scattered from the skin of the subject; (d) creating a scattering profile of the collected photons from the lesion on skin of the subject; (e) applying a transient force to the lesion on the skin of the subject through the end surface of the device; (f) repeating steps (a) through (e) to create a scattering profile of the collected photons from the area of skin of the subject to the applied transient force;” in claim 35. Such limitations are conventional and routine in the art (see Pilon et al., U.S. Patent Application Publication No. 2007/0156037 A1 (“Pilon”), which is discussed below), and add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the abstract idea.
The additional limitations of dependent claims 36-57 are merely directed to and further narrow the scope of the mental process.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide computer implementation of the abstract idea using collected data without: improvement to the functioning of a computer or to any other technology or technical field; applying the mental process with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; applying or using the mental process in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment; or adding a specific limitation other than what is well-understood, routine, conventional activity in the field.
Claim Rejections - 35 USC § 112
11. 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.
12. Claims 36 and 48 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 36 recites the limitation “performed repeatedly until a temporal relationship across instances is generated”. It is unclear as to what the term “instances” refers to, and what elements or parameters the temporal relationship is across. For examination purposes, the limitation will be interpreted as “performed repeatedly until a temporal relationship acrossthe scattering profile is generated”.
Claim 48 recites the limitation “wherein the analyzing comprises quantifying at least one of amplitudes, temporal gradients, temporal shapes or any combination thereof” in lines 1-2. There is insufficient antecedent basis for phrase “the analyzing” in the claim. It is unclear which step in base claim 35 the phrase “the analyzing” refers to. For examination purposes, the limitation will be interpreted as “further comprising quantifying at least one of amplitudes, temporal gradients, temporal shapes or any combination thereof”.
Claim 54 recites the limitation “the analyzed scattering profile” in line 2. There is insufficient antecedent basis for the limitation in the claim. For examination purposes, the limitation will be interpreted as “a comparison of dynamic changes in the scattering profile of the detected ultrasonic energy”.
Claim 55 recites the limitation “wherein the analyzing comprises determining one or more features of the skin of the subject” in lines 1-2. There is insufficient antecedent basis for phrase “the analyzing” in the claim. It is unclear which step in base claim 35 the phrase “the analyzing” refers to. For examination purposes, the limitation will be interpreted as “further comprising determining one or more features of the skin of the subject”.
Claim 55 recites the limitation “one or more features of the skin of the subject” in line 2. It is not clear what type of features of the skin the claim refers to. For examination purposes, the limitation will be interpreted as “one or more features of the skin of the subject including hydration level, skin thickness or melanin content”.
Claim 56 recites the limitation “the analyzed scattering profile” in line 5. There is insufficient antecedent basis for the limitation in the claim. It is unclear which step in base claim 35 the phrase “the analyzing” refers to. For examination purposes, the limitation will be interpreted as “further comprising quantifying at least one of amplitudes, temporal gradients, temporal shapes or any combination thereof”.
Allowable Subject Matter
13. Claims 35-57 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office Action.
14. The following is a statement of reasons for the indication of allowable subject matter:
As to Claim 35, Pilon et al., U.S. Patent Application Publication No. 2007/0156037 A1 (“Pilon”), teaches the following:
A method for detecting a biological state of a subject (see “A time-resolved fluorescence device is described for the detection and diagnosis of various metabolic diseases in a noninvasive or minimally invasive manner.” in Abstract), the method comprising;
(a) applying a device (“clip-on optometric device”) 70 (see fig. 5) to a lesion on skin of the subject (see “The clip-on optometric device 70 is configured to be positioned on opposing sides of the skin flap 78 between the thumb 80 and forefinger 82, as shown in FIG. 6. Alternatively, the clip on device 70 may be used on the patient's earlobes. In this region, blood vessels and fat are fairly limited and only skin is present. It also offers larger surface area for adequate optical contact between the non-invasive device 70 and the skin 80. Other possible sensing areas include the tongue and lips of the patient.” in para. [0082]), [an] end surface of the device comprising a photonic emitter (“upper head 74”) 74 and a photonic sensor (“lower head”) 76 (see “Each sensor head may have one or more light guides 86 for directing and transmitting optical signals. For example, upper head 74 may have fiber optics or light guides for directing excitation light 88 from a diode, and for transporting the reflected and fluorescence signal 90 to the detector. Correspondingly, the lower head 76 may have a light guide for directing the transmitted and fluorescence signal to the detector.” in para. [0083]), the photonic emitter 74 and photonic sensor 76 placed a predetermined distance from each other (see “The upper and lower heads 74, 76 are configured to be positioned on opposing sides of skin flap 78, and pressure may be applied to the skin flap 78 via spring 84 to ensure proper optical contact.” in para. [0083]);
(b) emitting, from the device 70, photons from the photonic emitter 74 having at least one wavelength onto the skin of the subject, wherein the photons scatter from subcellular structures of the skin differently based on a wavelength of the photon (see “The pulse of excitation light 16 is partially absorbed and scattered by the different skin layers 20. The absorbed light excites one or more fluorophores in the skin which in turn fluoresce 30.” in para. [0068]; and see “The transport of excitation and fluorescence light in skin was modeled using the steady-state radiative transfer equation (RTE) which governs light transport in absorbing, emitting and scattering media.…” in para. [0093]);
(c) detecting, by the device, photons with the photonic sensor that are scattered from the skin of the subject (see “Correspondingly, the lower head 76 may have a light guide for directing the transmitted and fluorescence signal to the detector.” in para. [0083]; and see “In time-resolved fluorescence, the fluorophores are present throughout the tissue and the fluorescent light is absorbed and scattered before emerging from the tissue and reaching the detector.” in para. [0091]);
(d) creating a scattering profile of the collected photons from the lesion on skin of the subject (see “The time-resolved fluorescence, reflectance, and transmittance data received from each patient may be collected and stored in a confidential database.” in para. [0087]);
(e) applying a transient force (“pressure”) to the lesion on the skin of the subject through the end surface of the device 70 (see “The upper and lower heads 74, 76 are configured to be positioned on opposing sides of skin flap 78, and pressure may be applied to the skin flap 78 via spring 84 to ensure proper optical contact.” in para. [0083]);
(f) repeating steps (a) through (e) to create a scattering profile of the collected photons from the area of skin of the subject to the applied transient force (see “In one embodiment, the light guides may also be translationally and angularly oriented with respect to each other to vary the light path traveled through the skin. For example, the detector light guides may be oriented off normal, and away from the excitation source light guides. The light guides and/or heads may be motorized to vary angle or position, or, an array of light guides may be positioned on the head at different locations and orientations, thus capable of retrieving a number of data points corresponding to the different locations or orientations.” in para. [0084]);
As to Claims 35-57, neither Pilon nor the prior art of record teaches the method of base claim 35, including the following, in combination with all other limitations of the base claim:
(g) comparing dynamic changes in the scattering profile of the [detected] photons from the lesion on [the] skin of the subject in response to the applied transient force; and
(h) outputting a biological state of the subject based at least in part on the comparison of the scattering profile of the [detected] photons from the lesion on [the] skin of the subject with the scattering profile of the collected photons in [a] presence and absence of applied transient force.
Conclusion
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 01/06/2026