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
Claims 31-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 4/17/2026.
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 11-13 and 26-28 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.
The term “safe” in claims 11-13 and 26-28 is a relative term which renders the claim indefinite. The term “safe” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the type of product is rendered indefinite. For the purpose of examination, it is interpreted as “set of product”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 12 and 27 recites the broad recitation “patient data and preferences”, and the claim also recites “can include: patient age, patient gender, patient skin type and texture, pre-existing skin concerns, climate-related aspects of the patient's current or selected geographic location, and product preferences of the patient” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purpose of examination, it is interpreted as not required. Claims 13 and 28 are rejected based upon their dependencies on the rejected claims.
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.
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.
Claims 1, 3, 5-7, 9, 14-16, 18, 20-22, 24, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over US20150025412A1 (Gillman et. al), cited by Applicant and hereto referred as Gillman, and in view of US20190183405A1 (Lee et. al), hereto referred as Lee.
As to claims 1 and 16, Gillman teaches a method for detecting skin contact reactions to a set of allergens (Gillman, abstract), comprising: enabling a user to acquire an image of a patch area through a camera in a portable device (Gillman, [0011], “The allergy test type identifier or the template type identifier may be obtained via a camera unit”),
preprocessing the image so that a resulting preprocessed image of the patch area has a prespecified size and orientation (Gillman, [0056], “The reference marker 210 may be of a predetermined size, location, and/or orientation with respect to the panel 202.”);
performing image-processing operations on the raw or preprocessed image to identify regions of the patch area corresponding to positive skin contact reactions (Gillman, [0085], “For example, the allergy test results application includes image processing algorithms for performing pattern recognition, object recognition, gradient matching, and/or edge matching using edge detection techniques (e.g., Canny edge detection).”);
and labelling each identified region with a specific allergen that was applied to the region to produce test results, which identify specific allergens that produced positive skin contact reactions (Gillman, [0085], “The processing unit 112a uses the algorithms included in the allergy test results application to identify puncture site marking regions, identify corresponding puncture site area regions, and determine whether an allergic reaction region is included in each of the puncture site area regions. For each allergic reaction region determined to be present, the processing unit 112a determines the size of a wheal region and the size of a flare region, and determines a corresponding size of a wheal and size of a flare formed on the skin 902 of the test subject, assigns a test score based on the sizes, and associates the test score with a test substance identifier.”)
However, Gillman does not teach a patch to deliver the allergens to skin. Lee teaches a relevant art of detecting skin contact reactions to a set of allergens (Lee, abstract). Lee teaches a method wherein the patch area is located on the skin of a patient, and wherein a patch containing the set of allergens was applied to the patch area for a period of time and removed before the image was acquired (Lee, [0030], “attaching the micro-needle patch to a predetermined region of a living body; after a pre-set time has elapsed, removing the attached micro-needle patch; and checking an allergic reaction by comparing the predetermined region with a region adjacent thereto.”; [0031], “checking the allergic reaction includes: obtaining an image of the predetermined region and an image of the adjacent region, respectively; processing the obtained images; and checking the allergic reaction using the processed images.”) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gillman in view of Lee to include a step wherein a patch area is located on the skin of a patient, and wherein a patch containing the set of allergens was applied to the patch area for a period of time and removed before the image was acquired because doing so would allow for painless application of the allergens to the skin (Lee, abstract, “diagnosing or treating the allergy disease easily and efficiently without causing great pain to the patient”).
As to claims 3 and 18, Gillman-Lee teaches enabling the user to acquire the image through the camera involves: displaying an image of what is being viewed by the camera to a user; and allowing the user to adjust a position of the camera to acquire a visible image of the entire patch area (Gillman, [0093], “For example, the processing unit 112a may instruct the video interface 154 to cause the first image data to be displayed by the monitor 152, and an operator may depress a button on the mouse 148 and move the mouse to 148 to cause an indication of a region of interest 1416 to be displayed around the image of the allergic reaction 1408b displayed by the monitor 152.”).
As to claims 5 and 20, Gillman-Lee teaches multiple images are acquired at different times (Gillman, [0075], “the medical professional uses the camera unit 164 to capture an image of the markings”; [0081], “For example, a medical professional may use the camera unit 164 to capture one or more images of the test area 900 and causes the camera unit 164 to transmit the image data to the processing unit 112 a”)
As to claims 6 and 21, Gillman-Lee teaches preprocessing the image involves performing one or more of the following preprocessing operations: shifting the image; rotating the image; scaling the image; cropping the image; adjusting a brightness of the image; adjusting a contrast of the image; adjusting the image for baseline skin tone, pigment or color; and using machine learning to enhance or normalize selected qualities of the image (Gillman, [0049], “However, the program(s) can be implemented in assembly or machine language, if desired. In any case, the language may be a compiled or interpreted language, and combined with hardware implementations.”).
As to claims 7 and 22, Gillman-Lee teaches one or more of the preprocessing operations are performed with reference to patch registration marks, which were transferred from the patch to the skin while the patch was applied to the skin (Gillman, [0077], “The illustrated embodiment may also include applying a reference marking 908 to the skin of the test subject at 708.”).
As to claims 9 and 24, Gillman-Lee teaches performing the image-processing operations to identify the regions of the patch area corresponding to positive skin contact reactions comprises using a machine-learning model to recognize positive skin contact reactions based on variations in skin color/pigment and/or skin texture (Gillman, [0015], “ant colony optimization”, “obtain an indication of a first color; and obtain an indication of a second color, wherein the second image data includes an indication that the first polygon has the first color and an indication that the second polygon has the second color.”).
As to claims 14 and 29, Gillman-Lee teaches the preprocessing operations and the image- processing operations are performed by one or more of: the portable device; and a remote cloud- computing system (Gillman, [0043], “The computer system 100 may also include a plurality of interfaces such as network interface 160 and interface 150 supporting modem 162 or any other wireless/wired interfaces.”).
As to claims 15 and 30, Gillman-Lee teaches the portable device comprises one of: a smartphone, a tablet computer and a digital camera with a processor (Gillman, [0011], “The allergy test type identifier or the template type identifier may be obtained via a camera unit.”).
Claims 2 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gillman-Lee as applied to claims 1 and 16 above, and further in view of US20170347938A1 (Mena Benito et. al), hereto referred as Mena Benito
As to claims 2 and 17, Gillman-Lee teaches the patch was applied to the patch area for and was removed before the image was acquired (Gillman, [0082], “predetermined amount of time (e.g., 15 minutes) after the test substances were applied”; Lee, [0120], “the patch may be removed 2 hours after the micro-needle is inserted into the skin”). However, Gillman-Lee does not teach the time duration for the patch application and removal before acquiring the image. Mena Benito teaches a relevant art of allergic testing on skin (Mena Benito, abstract). Mena Benito teaches a patch was applied to the patch area for approximately two days and was removed for approximately two to three days before the image was acquired (Mena Benito, [0005], “The patch is left in place for 48 hours… then an additional reading is made 3 to 4 days after the initial placement (i.e. 1-2 days after removal)”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gillman-Lee in view of Mena Benito to include that the patch was applied to the patch area for approximately two days and was removed for approximately two to three days before the image was acquired to ensure enough amount of time is given to observe allergic reactions.
Claims 4, 8, 10-13, 19, 23, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Gillman-Lee as applied to claims 1 and 16 above, and further in view of US20180260871A1 (Harvill et. al), hereto referred as Harvill.
As to claims 4 and 19, Gillman-Lee teaches more than one image is acquired and processed (Gillman, [0081], “For example, a medical professional may use the camera unit 164 to capture one or more images of the test area 900”). However, Gillman-Lee does not teach accounting for differing lighting conditions, skin tone, and skin textural changes. Harvill teaches solution to a relevant art of assessing skin using images (Harvill, abstract). Harvill teaches accounting for differing lighting conditions, skin tone, and skin textural changes (Harvill, [0073], “Ambient lighting information associated with at least one of the skin region images may also be received, and the at least one skin region image can be processed based at least in part on the ambient lighting information.”; [0077], “The same process is run against a calibration marker and then a set of targets representing skin tones.”; [0261], “Each user interaction preferably includes an updated user scan and user profile review such that the application can detect any changes in the user's skin tone, blemishes” ). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gillman-Lee in view of Harvill to include accounting for differing lighting conditions, skin tone, and skin textural changes because Gillman already recognizes the need to remove variables that affect the diagnosis and Harvill provides a predictable method (Gillman, [0100], “At 1310, the computer system removes noise from the image data corresponding to at least one region of interest. For example, the processing unit 112 a may remove noise from the image data corresponding to the region of interest 1416”)
As to claims 8 and 23, Gillman-Lee teaches preprocessing the image, but does not teach the details of the preprocessing. Harvill teaches using a machine-learning technique to normalize the image for varying light conditions, skin tone, and contrast (Harvill, [0049], “In this embodiment, an algorithm is used to search the ground truth dataset and find a mix using a search key. The algorithm is selected to perform at least the following steps: (a) it traverses entries in the ground truth dataset and finds the record whose key is closest to the search key; (b) it finds those records that are nearby, and assembles them into a set called a neighborhood; (c) it solves for the contributions from each entry in the neighborhood that best matches the search key; and (d) it uses the found contributions to calculate the mix formula.”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gillman-Lee in view of Harvill to include using a machine-learning technique to normalize the image because doing so would allow reducing errors that device from varying light conditions, skin tone, and contrast.
As to claims 10 and 25, Gillman-Lee-Harvill teaches the machine-learning model comprises a neural network or a related deep-learning architecture (Gillman, [0015], “ant colony optimization”).
As to claims 11 and 26, Gillman-Lee teaches obtaining the results of allergen test (Gillman, [0004], “a test result indicating the degree to which the test subject is allergic to the test substance”), but does not teach using the test results to filter a product catalog based on lists of known product ingredients to produce a set of safe product recommendations for the patient. Harvill teaches using test results to filter a product catalog based on lists of known product ingredients to produce a set of safe product recommendations for the patient (Harvill, [0261], “In one embodiment of editing a user's search key, these products may displayed as a set of choices. The choices may be ranked by “closest match” value (99% rank, 80% rank, etc.) and displayed either graphically or by using a “try-on” software to allow the user to display the recommendations as ranked on an image of the user.”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Gillman-Lee in view of Harvill to include using the test results to filter a product catalog based on lists of known product ingredients to produce a set of safe product recommendations for the patient because it would help reduce unwanted skin reaction, as recognized by Harvill (Harvill, [0003], “In the best of all possible worlds, these protective topical agents would be specified by a team of experts for a particular individual with specific needs, and for a specific environment or use.”).
As to claims 12 and 27, Gillman-Lee teaches producing the set of safe product recommendations additionally involves considering patient data and preferences, which can include: patient age, patient gender, patient skin type and texture, pre-existing skin concerns, climate-related aspects of the patient's current or selected geographic location, and product preferences of the patient (Gillman, [0101], “For example, the processing unit 112 a may process pixel values included in the image data corresponding to the region of interest 1416 to determine whether discoloration of the skin 1402 has occurred that is consistent with an allergic reaction”).
As to claims 13 and 28, Gillman-Lee does not teach product recommendation. Harvill teaches the set of safe product recommendations produce a personalized list further tailored and/or filtered to an individual retail vendor or brand (Harvill, [0101], “(e.g., allow the user to indicate desired cosmetics, indicate preferred brands or products previously used, allow the user to specify any allergies, capture skin imagery, and so on)”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Gillman-Lee in view of Harvill because doing so would allow the user to easily find off-the shelf products fitting for the user, as suggested by Harvill (Harvill, [0009], “each cosmetic primary component is a valid cosmetic product that meets applicable regulatory requirements”).
Response to Arguments
Applicant's arguments filed 4/17/2026 have been fully considered but they are not persuasive.
Applicant argues: “Nowhere in US20070048361 [Dupoint et. al, hereafter referred as Dupoint] is there any teaching regarding the use of the patch to deliver or expose the skin of a subject to more than one biologically active substance.” However, Dupoint teaches more than one allergen for testing (Dupoint, [0135], “The invention also relates to a patch kit comprising a plurality of patches as described above, each patch of the kit containing a constant or graduated amount of allergen and/or different allergens.”). Applicant also alleges “Furthermore, nowhere in US20070048361 is there any teaching of a patch having multiple wells or regions for delivery of different biologically active substances.” However, having multiple wells or regions for delivery of different biologically active substances it not recited in both groups of inventions, and the limitations are not shared technical feature. Furthermore, Dupoint does teach having multiple wells or regions (Dupoint, Fig. 5, [0136], “In the latter case, the support has several areas having electrostatic properties, advantageously in the form of hollows, each covered with a different test allergen, each electrostatic area being separated by a nonelectrostatic area.”). As such, the restriction is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELINA S JANG whose telephone number is (571)272-7019. The examiner can normally be reached M-F 9:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELINA SOHYUN JANG/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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