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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Elements 440,480 are not referenced in the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 7 is objected to because of the following informalities: Claim 7 recites “a wearer” in line 2, but instead should be --the wearer--. Appropriate correction is required.
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:
Imaging apparatus in claim 1 is referring to a CCD or COMS camera, or a digital camera (¶[0033]).
Processing apparatus is a chip with software (¶[0049]).
Output apparatus in claim 10 is referring to a display or speaker (¶[0051]).
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 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 8-10 and 12-15 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 12 recites “and other psychotic disorders” in line two, but is indefinite. How can this device be used for any and all psychotic disorders? Is it a specific list of “other” disorders? Amendment required.
Claim limitation “extraction unit,” “comparison unit,” “determination unit,” “communication apparatus,” and “timing apparatus” in claims 8-10 and 13-15 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. Each element is merely recited with the same language as in the claims, but fails to provide which structure performs the particular steps. 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.
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 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.
Claims 1-13 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Artificial intelligence-assisted niacin skin flush screening in early psychosis identification and prediction- 2022), hereinafter Chen, and further in view of Kennedy (US 20140275862), hereinafter Kennedy.
Regarding claim 1, Chen teaches a wearable device for skin testing (fig. 1 and 2), comprising: a main body comprising a first assembly part and a second assembly part (fig. 1, plurality of parts, arm tray 3 and elements across therefrom (4 and 5 for reference) constitute the first part and second part, respectively);
a liquid carrying apparatus, and having a reaction area for contact with a wearer's skin to be tested (see Methods ¶[0001], filter paper patches are used to apply the aqueous solution, while the arm is in the main body, and where the reaction occurs); and
an imaging apparatus, the imaging apparatus being assembled on the main body by means of the second assembly part, and being configured to image the tested skin (fig. 1, the camera is placed across the first assemble part (3), see (5) for reference. This is considered the second assembly part).
Chen fails to teach wherein the liquid carrying apparatus being assembled on the main body by means of the first assembly part.
Kennedy is in a related area and teaches a medical testing device comprising a main body main body 628, and its equivalents in other embodiments, which are formed with a top portion (that connects to the cap 26 and camera 609, and the like in the other embodiments), considered the second assembly, and a lower portion that connects to a liquid carrying strip 620 (¶[0042-3,0051] and fig. 5C, the test area (522) is configured be placed on “the skin of the patient in the test area with iodine 206” along with “introducing pilocarpine into the test area with iontophoresis” indicating that test strip holds iodine solution, pilocarpine solution, and sweat, which are all liquids), considered the first assembly. Carrying strip 620 is considered the liquid carry apparatus, the strip comprising segments 521, and are configured to be assembled on the first assembly (fig. 5B-3 and ¶[0051]). That is, Kennedy teaches a medical testing device that is configured to take an image of a test strip to determine a concentration of a physiological parameter, e.g. analyte, much like the invention of Chen which is a medical testing device configured to determine a concentration of niacin’s reaction with the body via a strip/patch.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Chen, such that the liquid carrying apparatus being assembled on the main body by means of the first assembly part, as taught by Kennedy, to aid in correctly positioning the testing area relative to the camera (¶[0051]).
Regarding claim 2, Chen teaches a test patch component (see Methods ¶[0001]), the test strip component further comprising a test paper (see Methods ¶[0001], filter paper), and is capable to carry a test reagent, but fails to teach that the test strip component comprises a mounting sheath, the test paper is connected to the mounting sheath, and wherein the mounting sheath is fitted onto the reaction area of the liquid carrying apparatus.
Kennedy teaches a test strip (fig. 5A-E), that comprises a mounting sheath (523), the mounting sheathes (523) are fitted onto the test strip, therefore also the reaction area, which is removed before use (¶[0064], 523 is a protective liner used to protect both sides of the test strip before use).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Chen, such that the test patch is a test strip component with a mounting sheath and a test paper, wherein the mounting sheath is fitted onto the reaction area, and the test paper is connected to the mounting sheath, as taught by Kennedy, as it would merely be substituting of one known element (test strip placed on the skin, with a liquid, for image analysis) for another (test patch placed on the skin, with a liquid, for image analysis) to obtain predictable results (analyzing test strip for skin test). This is further enforced because both Chen and Kennedy are solving the same problem, measuring physiological parameters of a subject by using a testing element placed on the skin for image analysis. Moreover, modification with the mounting sheath aids in protecting the test strip before use and accurately detecting physiological parameters with a camera (¶[0064] of Kennedy).
Regarding claim 3, Kennedy teaches wherein the test strip component further comprises a limiting frame, the limiting frame being connected to the test paper and limiting the contact area between the test paper and the skin to be tested (¶[0064], the test strip comprises a limiting frame between the two adhesive regions 521. See fig. 5A-C, reproduced below. The middle region is the limiting frame that limits the contact area to the middle region, since the adhesive regions do not contain elements for analysis).
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Regarding claim 4, Chen-Kennedy teach wherein the liquid carrying apparatus is detachably assembled on the main body by means of the first assembly part (¶[0064] of Kennedy, adhesive regions are capable of being detached from the first assembly as modified); and the imaging apparatus is detachably assembled on the main body by means of the second assembly part (¶fig. 1 of Chen, the camera is located on the upper/second part, which requires placement, thus detachable), wherein, when the imaging apparatus is assembled on the main body by means of the second assembly part (fig. 1C, the main body (below the component housing the camera) is considered the second assembly part). Chen fails to teach a closed space is formed between the wearable device and the skin to be tested.
Kennedy teaches that its medical diagnostic device is one tubular device comprising a main body, a camera located at the top of the main body, and a test strip attached to the bottom part of the main body (fig. 6A-D). The test strip covers that majority of the opening, thus, the skin would cover the remaining gap when placed on a wide skin portion (fig. 6B).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Chen, such that a closed space is formed between the wearable device and the skin to be tested, as taught by Kennedy, to aid in quickly obtaining a high resolution, focused image (¶[0067] of Kennedy).
a closed space is formed between the wearable device and the skin to be tested.
Regarding claim 5, Chen fails to teach wherein the first assembly part and the second assembly part are the same part of the main body.
Kennedy teaches that main body (627, 727, 927) that comprises a first (lower) and second (upper) assembly parts for receiving the camera (609, 730,937) and test strip (620,720) (¶[0066-69], the main body being the same part).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Chen, such that the first assembly part and the second assembly part are the same part of the main body, as taught by Kennedy, to aid in quickly obtaining a high resolution, focused image (¶[0067] of Kennedy).
Regarding claim 6, Chen teaches that the first assembly part and the second assembly part is a cavity (fig. 1A-C, a cavity is created with both assembly parts).
Regarding claim 7, Chen teaches a processing apparatus configured to determine a brain health level of a wearer based on imaging results from the imaging apparatus (see Methods, diagnostic result of schizophrenia is based on FES value being greater than 0.5, e.g. the level).
Regarding claim 8, Chen teaches wherein the processing apparatus further comprises: an extraction unit configured to extract feature information associated with the brain health level of the wearer based on the imaging results (see Methods, Cr values associated with erythema are obtained);
a comparison unit configured to compare the extracted feature information with a predetermined threshold (see Methods, the Cr value extracted is further analyzed and compared to a FES threshold and/or a classifier); and a determination unit configured to determine the brain health level of the wearer based on comparison results from the comparison unit (see Methods, if the FES value passes a threshold, a determination as to whether there was a schizophrenia episode).
Regarding claim 9, Chen teaches wherein the extraction unit is further configured to construct a color model based on the imaging results, and extract the feature information associated with the brain health level of the wearer based on image pixel color information in the color model (see Methods and fig, 3, the algorithm constructs a yellow, red, and blue color model. The red pixels are encoded with the Cr parameter, health level, used to determine schizophrenia episode).
Regarding claim 10, Chen teaches an output apparatus configured to output the brain health level of the wearer determined by the processing apparatus (see Methods, last paragraph, “the device could automatically perform an analysis in which the predetermined classifier would generate a test report based on the individual’s standardised Cr density obtained from the forearm images” indicating that the device outputs the user Cr value information. The Cr value being an image result and the health level to which a schizophrenia episode corresponds to).
Regarding claims 11-12, Chen teaches wherein the brain health level of the wearer refers to the health level of the wearer concerning mental disorders and/or neurological diseases, wherein the mental disorder includes
schizophrenia spectrum (see Methods, Cr value is related to schizophrenia).
Regarding claim 13, Chen teaches a timing apparatus configured to start timing when the test reagent comes into contact with the skin to be tested (see supplementary video in Methods section. The video shows a timer manually being started when the reagent comes into contact with skin).
Regarding claims 16-18, Chen teaches wherein the test reagent is an HCAR2 receptor activator, which is niacin (see Abstract).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Kennedy, as applied to claim 1, and further in view of Wang et al. (US 20180132783), hereinafter Wang.
Regarding claim 14, Chen-Kennedy fails to teach wherein the timing apparatus further configured to issue a first instruction in response to the timing reaching a predetermined first time threshold, wherein the first instruction instructs issuing a reminder signal and/or instructs unloading the liquid carrying apparatus from the main body.
Wang teaches a medication adherence device that includes a chemical marker sensor, configured to determine whether a user has taken a therapeutic agent (abstract). Wangs device is configured to use chemical sensors that detect a chemical reaction occurring from niacin, to determine whether the user is adhering to their medication regime (¶[0036,0045]). The wearable device is further configured to output reminders from a digital calendar for the user, that is, when a predetermined time threshold is reached (¶[0036]). The language is written in the plural form, indicating that multiple reminders can be set to instruct the user, and corresponding images based on the user’s adherence to the reminder.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Chen-Kennedy, such that first instructions are delivered based on satisfying threshold criteria to remind a user, as taught by Wang, to aid in helping a user adhere to a medication regime (¶[0007] of Wang).
Regarding claim 15, Chen teaches wherein the timing apparatus is further configured to issue a second instruction in response to the timing reaching one or more predetermined second time thresholds, wherein the second instruction instructs the imaging apparatus to image the tested skin (see Methods, an image is captured in 5 minute intervals. That is, the device is instructed, after meeting a threshold criteria, to take an image).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Heikenfeld teaches skin product testing often involves the influence of sweat on the product performance, such as adhesives, textiles, cosmetics, therapeutics, or any other type of testing of a product or even a skin condition. US 20200253512
Cole teaches methods and devices for determining the presence of such compositions on a surface, such as skin and niacin. US 20060244961
Sun teaches providing niacin compound solution, preferably 0.08-0.12 M methyl nicotinate solution and (b) contacting skin of the subject with niacin compound solution for 0.5-2 minutes, stopping contacting, and detecting redness and swelling of skin after 5 minutes, where if there is no redness it indicates that subject has a higher incidence of mental illness or mental illness than the normal population. WO 2019063026
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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