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 .
Response to Amendment
Amendment received on 2/12/2026 is acknowledged and entered. Claims 2 have been canceled. Claims 1 and 5-8 have been amended. Claims 1 and 3-9 are currently pending in the application.
Objections to the drawings, Specification and claim objections have been withdrawn due to the Applicant’s amendment.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/12/2026 is being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Claim Rejections - 35 USC § 102
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 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 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.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DIMAURO G ET AL., (Dimauro) "Detecting clinical signs of anaemia from digital images of the palpebral conjunctiva". (IDS of 12/11/2023)
Claim 1. Dimauro discloses a device for non-invasively estimating an anaemia condition in a subject to be evaluated, said device comprising a spacer configured, in use, to be contacted with a periocular area of said subject to be evaluated, said periocular area which comprises an eye of said subject; said spacer comprising a hollow body which comprises, in turn, a supporting surface configured, in use, to be contacted with said periocular area of said subject to be evaluated and a cavity extending longitudinally in said body starting from said supporting surface; Fig. 3; P. 113491, Technical Problems;
said device being characterized in that:
said supporting surface is configured to adapt to the shape of the frontal bone, zygomatic bone and maxillary bone of said subject to be evaluated; Fig. 3; P. 113491, Technical Problems;
and characterized in that it comprises:
an imaging unit combined with said cavity and comprising a camera configured to capture an image of said periocular area; P. 113491, Technical Problems; (a smartphone)
an optical unit combined with said imaging unit and comprising at least one lens; P. 113491, Technical Problems; (a macro-lens)
a lighting unit arranged inside the spacer and combined with said cavity and configured to illuminate a space inside said cavity, preferably arranged in the proximity of the optical unit; P. 113491, Technical Problems; (LED lights)
a display for displaying said image; P. 113491, Technical Problems; (a smartphone)
a computerized processing unit operatively combined with said imaging unit and said lighting and display units, said computerized processing unit being configured to receive said image from said imaging unit and to process it, by implementing algorithms installed therein, in order to estimate the anaemia state of the subject to be evaluated and to send a result of the aforesaid processing to said display. P. 113491, Technical Problems; P. 113492, 1st ¶; P. 113494, P. 113495, 1st ¶, Experimental Results; Manual segmentation of the Palpebral Conjunctiva (software; a trained classifier),
wherein said body of the spacer comprises a user surface opposite said supporting surface, configured to accommodate said optical unit, said display, said computerized processing unit and the imaging unit. Fig. 3 (an area of the spacer to which said smartphone is attached)
Claim 3. The device according to claim 1, wherein said cavity extends in said body from said supporting surface to said user surface; said display being arranged to close said cavity. Fig. 3; P. 113491, Technical Problems
Claim 4. The device according to claim 1, wherein the supporting surface is shaped or moulded to adapt and adhere to said periocular area of said subject to be evaluated. Fig. 3; P. 113491, Technical Problems
Claim 5. Dimauro discloses a method for non-invasively estimating the anaemia state in a subject to be evaluated by using the device according to claim 1, said method comprising the steps of:
i) displaying the palpebral conjunctiva and controlling the framing through at least one miniature video camera of the imaging unit of the device according to claim 1 any one of the preceding claims, by means of a display of said device; Fig. 3
ii) capturing an image of the palpebral conjunctiva by photographic obtaining an image of said miniature video camera; Fig. 3; P. 113491, Technical Problems;
iii) selecting, on said display, an area of said image which captures said area of the palpebral conjunctiva; P. 113492, 1st ¶; P. 113494, Experimental Results; Manual segmentation of the Palpebral Conjunctiva
iv) processing said image by the aforesaid algorithms, thus obtaining an estimated value or estimation of the level of anaemia in said subject to be evaluated. P. 113492, 1st ¶; P. 113494, Experimental Results; Manual segmentation of the Palpebral Conjunctiva (software; a trained classifier)
Claim 6. Method according to claim 5, wherein said subject to be evaluated employs the device for a self-measurement. P. 113495, Conclusion
Claim 7. Method according to claim 5, wherein step iii) provides for manually selecting on said display said area of said image which captures said area of the palpebral conjunctiva. P. 113492, 1st ¶; P. 113494, Experimental Results; Manual segmentation of the Palpebral Conjunctiva
Claim 8. Method according to claim 5, wherein step iv) provides for performing image analysis algorithms for the extraction of information from said image and artificial intelligence algorithms for the estimation of the anaemia level in said subject to be evaluated. P. 113492, 1st ¶; P. 113494, P. 113495, 1st ¶, Experimental Results; Manual segmentation of the Palpebral Conjunctiva (software; a trained classifier)
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 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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Dimauro in view of Official Notice.
Claim 9. The device according to claim 1, wherein the display-is a LED display.
While Dimauro discloses the use of a smartphone, Dimauro does not specifically teach the type of the smartphone display. However, Official notice is taken that it is old and well-known that most modern smartphones, e.g. Samsung Galaxy S and Z series, Google Pixel Pro models, and Vivo and Xiaomi phones use OLED (Organic Light-Emitting Diode) displays, which are a type of LED technology; and the older and less expensive models use LED-backlit LCD screens. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dimauro to include the LED limitation, because LED screens offer wider viewing angles, high resolution, and high refresh rates.
Claims 1 and 3-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NOOR NAHIYAN BIN ET AL., (Noor) "Comparative study between decision tree, SVM and KNN to predict anaemic condition". (IDS of 12/11/2023)
Claim 1. Noor discloses a device for quickly and non-invasively estimating an anaemia condition in a subject to be evaluated, said device comprising a spacer configured, in use, to be contacted with a periocular area of said subject to be evaluated, said periocular area which comprises an eye of said subject; said spacer comprising a hollow body which comprises, in turn, a supporting surface configured, in use, to be contacted with said periocular area of said subject to be evaluated and a cavity extending longitudinally in said body starting from said supporting surface; Figs. 2 and 3; (a box-like structure adapted to align with the shape of the frontal bone, zygomatic bone and maxillary bone of a subject to be evaluated)
said device being characterized in that:
said supporting surface is configured to adapt to the shape of the frontal bone, zygomatic bone and maxillary bone of said subject to be evaluated; Figs. 2 and 3
and characterized in that it comprises:
an imaging unit combined with said cavity and comprising a camera configured to capture an image of said periocular area; Figs. 2 and 3; P. 25 (a smartphone)
an optical unit combined with said imaging unit and comprising at least one lens; Figs. 2 and 3; P. 25 (a smartphone)
a lighting unit arranged inside the spacer and combined with said cavity and configured to illuminate a space inside said cavity, preferably arranged in the proximity of the optical unit; P. 25 (a flashlight of the smartphone, or other provisions adapted to let any light to enter into the box)
a display for displaying said image; P. 25 (a smartphone)
a computerized processing unit operatively combined with said imaging unit and said lighting and display units, said computerized processing unit being configured to receive said image from said imaging unit and to process it, by implementing algorithms installed therein, in order to estimate the anaemia state of the subject to be evaluated and to send a result of the aforesaid processing to said display, P. 25 (the images are taken to MATLAB for processing); P. 26, (regression and classification models)
wherein said body of the spacer comprises a user surface opposite said supporting surface, configured to accommodate said optical unit, said display, said computerized processing unit and the imaging unit. Figs. 2 and 3 (a portion of the box-like structure adapted to receive the smartphone)
Claim 3. The device according to claim 1, wherein said cavity extends in said body from said supporting surface to said user surface; said display being arranged to close said cavity. Figs. 2 and 3 (the box-like structure adapted to be closed or covered by the smartphone)
Claim 4. The device according to claim 1, wherein the supporting surface is shaped or moulded to adapt and adhere to said periocular area of said subject to be evaluated. Figs. 2 and 3; (a box-like structure adapted to align with the shape of the frontal bone, zygomatic bone and maxillary bone of a subject to be evaluated)
Claim 5. Method for non-invasively estimating the anaemia state in a subject to be evaluated by using the device according to claim 1, said method comprising the steps of:
i) displaying the palpebral conjunctiva and controlling the framing through at least one miniature video camera of the imaging unit of the device according to claim 1 any one of the preceding claims, by means of a display of said device; Figs. 2 and 3; (a smartphone configured to capture images)
ii) capturing an image of the palpebral conjunctiva by photographic obtaining an image of said miniature video camera; Figs. 2 and 3; P. 25 (a smartphone configured to capture images)
iii) selecting, on said display, an area of said image which captures said area of the palpebral conjunctiva; P. 25 (the image is cropped and taken only the conjunctiva portion)
iv) processing said image by the aforesaid algorithms, thus obtaining an estimated value or estimation of the level of anaemia in said subject to be evaluated. P. 25 (the images are taken to MATLAB for processing); P. 26, (regression and classification models)
Claim 6. Method according to claim 5, wherein said subject to be evaluated employs the device for a self-measurement. Figs. 2 and 3
Claim 7. Method according to claim 5, wherein step iii) provides for manually selecting on said display said area of said image which captures said area of the palpebral conjunctiva. P. 25 (the image is cropped and taken only the conjunctiva portion)
Claim 8. Method according to claim 5, wherein step iv) provides for performing image analysis algorithms for the extraction of information from said image and artificial intelligence algorithms for the estimation of the anaemia level in said subject to be evaluated. P. 26, (regression and classification models)
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Noor in view of Official Notice.
Claim 9. The device according to claim 1, wherein the display-is a LED display.
While Noor discloses the use of a smartphone, Noor does not specifically teach the type of the smartphone display. However, Official notice is taken that it is old and well-known that most modern smartphones, e.g. Samsung Galaxy S and Z series, Google Pixel Pro models, and Vivo and Xiaomi phones use OLED (Organic Light-Emitting Diode) displays, which are a type of LED technology; and the older and less expensive models use LED-backlit LCD screens. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Noor to include the LED limitation, because LED screens offer wider viewing angles, high resolution, and high refresh rates.
Response to Arguments
Applicant's arguments filed 2/12/2026 have been fully considered but they are not persuasive.
Applicant argues that Dimauro or Noor are not anticipatory references, because they failed to disclose a system that integrates, within a single autonomous device, an imaging unit, an optical unit, a lighting unit, a display and a processing unit.
The Examiner respectfully disagrees, and notes, that Dimauro explicitly disclose said system, including comprising a spacer configured, in use, to be contacted with a periocular area of said subject to be evaluated, said periocular area which comprises an eye of said subject; said spacer comprising a hollow body which comprises, in turn, a supporting surface configured, in use, to be contacted with said periocular area of said subject to be evaluated and a cavity extending longitudinally in said body starting from said supporting surface, wherein said body of the spacer comprises a user surface opposite said supporting surface, configured to accommodate said optical unit, said display, said computerized processing unit and the imaging unit.
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Fig. 3; P. 113491, Technical Problems. (an area of the spacer to which said smartphone is attached)
Noor also explicitly disclose said system, including comprising a spacer configured, in use, to be contacted with a periocular area of said subject to be evaluated, said periocular area which comprises an eye of said subject; said spacer comprising a hollow body which comprises, in turn, a supporting surface configured, in use, to be contacted with said periocular area of said subject to be evaluated and a cavity extending longitudinally in said body starting from said supporting surface, wherein said body of the spacer comprises a user surface opposite said supporting surface, configured to accommodate said optical unit, said display, said computerized processing unit and the imaging unit.
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Figs. 2 and 3 (a portion of the box-like structure configured to accommodate a smartphone)
Applicant further argues that Dimauro does not disclose that it is configured to adapt to the shape of the frontal bone, the zygomatic bone, and the maxillary bone of the subject being evaluated.
The Examiner respectfully notes that Applicant admits that “Dimauro states that the spacer is configured so as to easily place it around the area of the eye.” So as Dimauro discloses that the spacer is configured to shield the inner cavity of the device from the external light, it follows that the spacer surface has to be adapted to accommodate the bridge of the nose, cheekbones, and jaw, ensuring no gaps allow the external light to enter the cavity, which is crucial for operating the system. As such, Dimauro discloses the recited limitation.;
Remaining Applicant’s arguments essentially repeat the arguments presented above; therefore, the responses presented by the Examiner above are equally applicable to the remaining Applicant’s arguments.
Conclusion
The prior art search has been conducted, with no significant prior art found.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
/IGOR N BORISSOV/Primary Examiner, Art Unit 3685 2/24/2026