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 with traverse of Group I, drawn to an allergen skin reaction detection and metrology system, in the reply filed on 11/7/25 is acknowledged.
The traversal is on the ground(s) that Groups 1 and 2 share a special technical feature linking the inventions, specifically including “a plurality of light sources arranged or positioned under angles greater than 40o with respect to a receiving direction, the plurality of light sources being configured to successively illuminate a skin surface area under a plurality of predetermined illumination angles with respect to the receiving direction” and Mir only shows incident light at 90 degrees.
This is not found persuasive because Mir explicitly discloses inter alia
“[0086] Image forming apparatus 110 also includes an illumination apparatus 120 that is energizable to direct suitable illumination toward exposed skin at opening 40 for obtaining images at image sensor 112. As shown in FIG. 7A, in illumination apparatus 120, a first light source 124 directs light that is substantially collimated and is directed toward opening 40 at an oblique angle .alpha. that is between about 45 degrees and 80 degrees from normal N. More preferably, oblique angle .alpha. is about 70+/-6 degrees from normal N. Substantially collimated light from light source 124 is at narrow angles, within about +/-15 degrees of the central angle that is at oblique angle .alpha.. With this configuration, light emitted from light source 124 is diffusely reflected from the skin surface, based on a Lambertian model for skin reflectance. Skin reflectance has both specular and diffuse components. The angle of incidence is variable at any point along the skin surface position at opening 40. With light at the oblique angles used; there is little or no effect from specular reflectance. First light source 124 has spectral content that is selected for improved sensitivity to contour. Laser, LED, incandescent, or fluorescent light sources that may include some collimating means may be used for first light source 124. Appropriately aligned polarizers may be placed at the source 124 and image sensor 112 to control specular reflection from the patient's skin that may hinder the measurements due to "glint spots".”.
The requirement is still deemed proper and is therefore made FINAL.
Claims 29-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/7/25.
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).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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. Such limitations include at least the following:
“testing means” of claim 16;
“illumination means” of claim 16;
“acquisition means” of claim 16; and
“analysing means” of claim 16.
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.
Claim Objections
Claims 16, 19, and 20 are objected to because of the following informalities: the positive recitation of “analysing” should apparently read “analyzing”. Appropriate correction is required.
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.
Claim(s) 16-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gizewski (US 2008/0161661 A1).
For claim 16, Gizewski discloses a system for detection and metrology of an allergen skin reaction of an individual (Fig 3) ([0002, 0033-0051]), wherein said system comprises inter alia:
testing means (1000) (Fig 3) ([0033-0051]) configured to host a body part of said individual and to subject a skin surface area of said body part to an allergen skin reaction test ([0002, claim 19])) (Fig 3) ([0033-0051]);
illumination means (lights of 300) (Fig 3) ([0033-0051]), comprising a plurality of light sources (300), and configured to successively illuminate said skin surface area having been subjected to said allergen skin reaction test under a plurality of predetermined illumination angles with respect to a receiving direction along which acquisition means (imagers of 300) are positioned (Fig 3) ([0033-0051]); and
wherein said light sources are positioned under an angle larger than 40 degrees with respect to said receiving direction (Fig 3) ([0033-0051]);
said acquisition means fixedly positioned with respect to said skin surface area along said receiving direction (Fig 3) ([0033-0051]),
wherein said acquisition means is configured to image, for each of said predetermined illumination angles, said illuminated skin surface (Fig 3) ([0033-0051]); and
analyzing means (350, 360, 500) configured to determine one or more illumination-angle-dependent variations in light intensity imaged by said acquisition means (Fig 3) ([0033-0051]),
wherein said illumination-angle-dependent variations are caused by one or more wheals on said skin surface area (Fig 3) ([0033-0051]).
For claim 17, Gizewski discloses the system according to claim 16, wherein: said skin surface area extends along a longitudinal direction (Fig 3) ([0033-0051]); said acquisition means are fixedly positioned with respect to said skin surface area along said receiving direction traverse to said longitudinal direction (Fig 3) ([0033-0051]); said predetermined illumination angles are formed between said receiving direction and a lighting direction for each of said light sources of said illumination means (Fig 3) ([0033-0051]), wherein a light source tangentially illuminates said skin surface area along said lighting direction (Fig 3) ([0033-0051]).
For claim 18, Gizewski discloses the system according to claim 16, wherein said acquisition means are further configured to capture one or more images of said skin surface area for each of said predetermined illumination angles (Fig 3) ([0033-0051]), thereby generating a set of images of said skin surface area for said allergen skin reaction test (Fig 3) ([0033-0051]).
For claim 19, Gizewski discloses the system according to claim 18, wherein analyzing means are further configured to process said set of images and to determine, from said set of images, one or more of the following: reflections generated from said illumination by said wheals on said skin surface area; shadows generated from said illumination by said wheals on said skin surface area; thereby determining said illumination-angle-dependent variations in light intensity imaged by said acquisition means (Fig 3) ([0033-0051]).
For claim 20, Gizewski discloses the system according to claim 16, wherein said analyzing means are further configured to determine a location of said wheal on said skin surface area using said illumination-angle-dependent variations in light intensity imaged by said acquisition means (Fig 3) ([0033-0051]).
For claim 21, Gizewski discloses the system according to claim 18, wherein said analysis means are further configured to determine, from said set of images, a size and/or a shape of one or more of said wheals on said skin surface area (Fig 3) ([0033-0051]).
For claim 22, Gizewski discloses the system according to claim 17, wherein said acquisition means are positioned along said receiving direction traverse to said longitudinal direction to image said illuminated skin surface under each of said predetermined illumination angles (Fig 3) ([0033-0051]).
For claim 23, Gizewski discloses the system according to claim 16, wherein said acquisition means are positioned at a fixed predetermined receiving distance from said skin surface area for all of said predetermined illumination angles (Fig 3) ([0033-0051]).
For claim 24, Gizewski discloses the system according to claim 16, wherein each light source is configured to illuminate said skin surface area (Fig 3) ([0033-0051]); and wherein said system further comprises one or more mounting supports configured to hold said light sources (Fig 3) ([0033-0051]).
For claim 25, Gizewski discloses the system according to claim 22, wherein said light sources and/or said mounting supports are further configured to rotate around said body part in a plane comprising said receiving direction and traverse to said longitudinal direction such that said light sources illuminate said skin surface area under said plurality of predetermined illumination angles (Fig 3) ([0033-0051]).
For claim 26, Gizewski discloses the system according to claim 22, wherein said light sources and/or said mounting supports are further configured to rotate around said body part in a plane comprising said longitudinal direction of said body part and said receiving direction such that said light sources illuminate said skin surface area under said plurality of predetermined illumination angles (Fig 3) ([0033-0051]).
For claim 27, Gizewski discloses the system according to claim 16, wherein said testing means is configured to simultaneously deposit one allergen at a predetermined position on said skin surface area and incise said skin surface area of said individual at each of said predetermined positions (Fig 3) ([0002, 0033-0051, claim 19]).
For claim 28, Gizewski discloses the system according to claim 16, wherein an angular spread of said light sources within said illumination means is comprised between 35 degrees and 55 degrees (Fig 3) ([0033-0051]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for dermatological assessment via illumination and imaging configurations.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791