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 .
Status of Claims
Applicant's arguments, filed 11/24/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 11/24/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant canceled claim 15 in the response filed on 11/24/2025.
Claims 1-14 are the current claims hereby under examination.
Claim Objections
Claim 8 is objected to because of the following informalities: “at least a subject’s hand” should read “at least said subject’s hand”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: “the method comprising executing program instructions, and comprises the following steps:” should read “the method executing program instructions, and wherein the program instructions comprise the following steps:”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 13 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 13, the claim recites “analyzing a heart rate of the subject from said video”. The specification as filed fails to provide adequate written description for how a heart rate of the subject is analyzed from said video. Paragraph [0019] of the specification simply restates the language of claim 13. Therefore, claim 13 fails to provide adequate written description as required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph because an indefinite, unbounded functional limitation would cover all ways of performing a function and indicate that the inventor has not provided sufficient disclosure to show possession of the invention (see MPEP 2163.03 (vi)).
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 1-14 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.
Regarding Claims 1, 8, and 11, the claims recite “to consistently place”. The term “consistently” is a relative term which renders the claims indefinite. The term “consistently” 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. The use of the term “consistently” renders the limitation said subject of placing a hand portion of said subject’s hand indefinite. Therefore, claims 1, 8, and 11 are rejected. Claims 2-7, 9-10, and 12-14 are rejected due to their dependence on claims 1, 8, and 11, respectively.
Regarding Claim 2, the claim recites “the range”. There is insufficient antecedent basis for this term. Examiner suggests amending the claim to read “a range”. The claim also recites “a color scale bar” twice. It is unclear if both recitations refer to the same color scale bar. For the purposes of examination, the second recitation of “a color scale bar” is herein interpreted to be the same as the first recitation of “a color scale bar”. Due to the aforementioned reasons, claim 2 is rendered indefinite. Claim 7 is rejected due to its dependence on claim 2.
Regarding Claim 9, the claim recites “the range”. There is insufficient antecedent basis for this term. Examiner suggests amending the claim to read “a range”. The claim recites “a field of view”. Claim 8, from which claim 9 is dependent, also recites “a field of view”. It is unclear if “a field of view” recited in claim 9 is the same as or different than the “a field of view” recited in claim 8. For the purposes of examination, “a field of view” recited in claim 9 is herein interpreted to be the same as the “a field of view” recited in claim 8. The claim also recites “a color scale bar” twice. It is unclear if both recitations refer to the same color scale bar. For the purposes of examination, the second recitation of “a color scale bar” is herein interpreted to be the same as the first recitation of “a color scale bar”. Due to the aforementioned reasons, claim 9 is rendered indefinite.
Further regarding Claim 11, the claim recites “outputting for display the hemoglobin level of the subject”. It is unclear how the hemoglobin level of the subject is outputted since there is no corresponding structure recited in the claim. Therefore, claim 11 is rendered indefinite.
Regarding Claim 14, the claim recites “the group”. There is insufficient antecedent basis for this term. Examiner suggests amending the claim to read “a group”. Therefore, Claim 14 is rendered indefinite.
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.
Claim(s) 1, 5, 6, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grubb et al. (WO 2018162732 A1 – previously cited) hereinafter Grubb in view of Choi et al. (EP 3685747 A1 – previously cited) hereinafter Choi.
Regarding Claim 1, Grubb discloses an apparatus for determining hemoglobin levels in a subject (apparatus for imaging blood within a target region of tissue (pg. 5, lines 12-13); Examiner notes the apparatus can be configured to determine hemoglobin levels), said apparatus comprising:
(i) a box defining an interior space (apparatus 2 (pg. 10, line 32); fig 1) comprising:
(a) an upper opening adopted to allow a camera placed on top of the box, to capture images of a subject's hand placed inside the interior space (camera module 16 is… arranged to capture images of the back of the hand 7 placed on the base 6 below (pg. 11, lines 13-15); fig 1), wherein a vertical distance between the upper opening and a bottom of the box is between 50 to 400 mm (support platform 12 may be spaced from the base 6 by between 5cm and 100cm (pg. 11, lines 7-8); fig 1);
and (b) a side opening configured for an insertion of said subject's hand (fig 1);
(ii) an adaptor, attached to an upper face to the box, for holding the camera and ensuing a location of a lens of said camera above the upper opening (support frame 4 therefore holds the light source 14 and the camera module 16 in a fixed special relationship with respect to each other and the base 6 (pg. 11, lines 15-16); fig 1; Examiner notes support frame 4 performs the same function as an adaptor);
and wherein a field of view of said camera captures the nail and the skin (camera module 16 is… arranged to capture images of the back of the hand 7 placed on the base 6 below (pg. 11, lines 13-15); fig 1; Examiner notes nail and skin would be included in an image of the back of a hand).
Grubb fails to disclose a placement pad located at the bottom of the box, having a texture configured to provide feedback to direct said subject to place a hand portion of said subject’s hand comprising a nail and a skin in a direction facing the lens.
However, Choi teaches a placement pad (finger contact surface 112, on which a user's finger 10 is placed to come into contact with the finger contact surface 112 [0035]; figs 1-3), having a texture configured to provide feedback to direct a subject to consistently place a hand portion of said subject’s hand comprising a nail and a skin (texture unit 116 is formed at the finger contact surface 112 to allow a user to feel a tactile sensation on the finger 10 when the finger 10 is in contact with the finger contact surface 112 [0035]; The texture interface 110 for measuring a bio-signal may induce a user to place the finger 10 in the same position every time the user measures a bio-signal at different times, thereby improving reproducibility of the bio-signal. [0036]; figs 1-3).
Choi is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art to have modified the apparatus of Grubb such that it includes a placement pad located at the bottom of the box, having a texture configured to provide feedback to direct said subject to place a hand portion of said subject’s hand comprising a nail and a skin in a direction facing the lens as taught by Choi, because it would allow said subject to feel a tactile sensation when the hand portion is correctly positioned inside the box for accurate imaging. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 5, Grubb in view of Choi teaches the invention as discussed above in claim 1. Grubb further teaches said camera is included in a smartphone (the portable hand-held device can be a smartphone, tablet, or the like with an integrated camera (pg. 20, lines 19-20)).
Regarding Claim 6, Grubb in view of Choi teaches the invention as discussed above in claim 1. Grubb further teaches said interior space has dimensions sufficient for an insertion of the hand of the subject at a spread-out position (fig 1).
Regarding Claim 8, Grubb discloses a kit (apparatus 2 (pg. 10, lines 32)) comprising:
i. a box defining an interior space (apparatus 2 (pg. 10, line 32); fig 1) comprising:
(a) an upper opening adopted to allow a camera placed on top of the box to capture images of a subject's hand placed inside the interior space (camera module 16 is… arranged to capture images of the back of the hand 7 placed on the base 6 below (pg. 11, lines 13-15); fig 1), wherein a vertical distance between the upper opening and a bottom of the box is between 50 to 400 mm (support platform 12 may be spaced from the base 6 by between 5cm and 100cm (pg. 11, lines 7-8); fig 1);
and (b) a side opening configured for insertion of at least a subject's hand (fig 1);
ii. an adaptor, attachable to an upper face of the box, for holding the camera and ensuing a location of the camera lens above the upper opening (support frame 4 therefore holds the light source 14 and the camera module 16 in a fixed special relationship with respect to each other and the base 6 (pg. 11, lines 15-16); fig 1; Examiner notes support frame 4 performs the same function as an adaptor); and
wherein a field of view of said camera captures the nail and the skin (camera module 16 is… arranged to capture images of the back of the hand 7 placed on the base 6 below (pg. 11, lines 13-15); fig 1; Examiner notes nail and skin would be included in an image of the back of a hand).
Grubb fails to disclose a placement pad to be located at the bottom of the box, having a texture configured to provide feedback to direct said subject to place a hand portion of said subject’s hand comprising a nail and skin in a direction facing a lens of said camera.
However, Choi teaches a placement pad (finger contact surface 112, on which a user's finger 10 is placed to come into contact with the finger contact surface 112 [0035]; figs 1-3), having a texture configured to provide feedback to direct a subject to consistently place a hand portion of said subject’s hand comprising a nail and a skin (texture unit 116 is formed at the finger contact surface 112 to allow a user to feel a tactile sensation on the finger 10 when the finger 10 is in contact with the finger contact surface 112 [0035]; The texture interface 110 for measuring a bio-signal may induce a user to place the finger 10 in the same position every time the user measures a bio-signal at different times, thereby improving reproducibility of the bio-signal. [0036]; figs 1-3).
It would have been obvious to one having ordinary skill in the art to have modified the apparatus of Grubb such that it includes a placement pad located at the bottom of the box, having a texture configured to provide feedback to direct said subject to place a hand portion of said subject’s hand comprising a nail and a skin in a direction facing the lens as taught by Choi, because it would allow said subject to feel a tactile sensation when the hand portion is correctly positioned inside the box for accurate imaging. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Claim(s) 2, 7, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grubb (WO 2018162732 A1 – previously cited) in view of Choi (EP 3685747 A1 – previously cited) as applied to claims 1 and 8 above, and further in view of Li et al. (US Patent Pub. No. 20190073763 – previously cited) hereinafter Li.
Regarding Claim 2, Grubb in view of Choi teaches the invention as discussed above in claim 1. Grubb in view of Choi fails to teach a color scale bar, located at said bottom of the box, displaying at least 3 colors characterized by a reflection of wavelength in the range of (i) 670-700nm; (ii) 520-560nm; and (iii) 450-490nm, wherein said field of view of said camera also captures the color scale bar.
However, Li teaches a color scale bar, located at a bottom of a box (a color pattern chart 180, as also shown in outline in FIGS. 1A and 1B [0050]; fig 2) displaying at least 3 colors characterized by a reflection of wavelength in a range of (i) 670-700nm; (ii) 520-560nm; and (iii) 450-490nm (the color pattern chart 180, which is associated with a specific test strip 216, with a predetermined type, make, and model of the test strip 216 [0051]; ii. a red-green-blue base color calibration strip 210, comprising a red color area 212, a green color area 214, and a blue color area 216 [0052]; fig 2), wherein a field of view of a camera also captures the color scale bar (such that the red-green-blue base color calibration strip 210 is provided for use in calibrating the camera 162 [0052]).
Li is considered analogous art to the present invention because the invention is reasonably pertinent to a problem faced by the inventors.
It would have been obvious to one having ordinary skill in the art at the effective filing date to have modified the apparatus of Grubb in view of Choi such that it included a color scale bar, located at said bottom of the box, displaying at least 3 colors characterized by a reflection of wavelength in the range of (i) 670-700nm; (ii) 520-560nm; and (iii) 450-490nm, wherein said field of view of said camera also captures the color scale bar as taught by Li. Doing so would allow for calibration of the camera and improved measurements. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 7, Grubb in view of Choi and further in view of Li teaches the invention as discussed above in claim 2. Grubb in view of Choi in view of Li further teaches said color scale bar further displays at least one grayscale portion (color pattern chart 180 including: i. a bar code 202 [0050-0051 of Li]; fig 2 of Li).
Regarding Claim 9, Grubb in view of Choi teaches the invention as discussed above in claim 8. Grubb in view of Choi fails to teach a color scale bar, adopted to be located at said bottom of the box, displaying at least 3 colors characterized by a reflection of wavelength in the range of (i) 670-700nm; (ii) 520-560nm; and (iii) 450-490nm, wherein a field of view of said camera also captures the color scale bar.
However, Li teaches a color scale bar, adopted to be located at a bottom of a box (a color pattern chart 180, as also shown in outline in FIGS. 1A and 1B [0050]; fig 2) displaying at least 3 colors characterized by a reflection of wavelength in a range of (i) 670-700nm; (ii) 520-560nm; and (iii) 450-490nm (the color pattern chart 180, which is associated with a specific test strip 216, with a predetermined type, make, and model of the test strip 216 [0051]; ii. a red-green-blue base color calibration strip 210, comprising a red color area 212, a green color area 214, and a blue color area 216 [0052]; fig 2), wherein a field of view of a camera also captures the color scale bar (such that the red-green-blue base color calibration strip 210 is provided for use in calibrating the camera 162 [0052]).
It would have been obvious to one having ordinary skill in the art at the effective filing date to have modified the apparatus of Grubb in view of Choi such that it included a color scale bar, adopted to be located at said bottom of the box, displaying at least 3 colors characterized by a reflection of wavelength in the range of (i) 670-700nm; (ii) 520-560nm; and (iii) 450-490nm, wherein a field of view of said camera also captures the color scale bar as taught by Li. Doing so would allow for calibration of the camera and improved measurements. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Claim(s) 3 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grubb (WO 2018162732 A1 – previously cited) in view of Choi (EP 3685747 A1 – previously cited) as applied to claims 1 and 8 above, and further in view of Segman (US Patent Pub. No. 20140018647 – previously cited).
Regarding Claim 3, Grubb in view of Choi teaches the invention as discussed above in claim 1. Grubb in view of Choi fails to teach a cover connected to the box, for covering the side opening for substantially blocking an amount of exterior light to be inserted within said interior space upon applying the camera on the adaptor and the subject's hand within said side opening.
However, Segman teaches a cover connected to a box (the apparatus housing includes… a cover 18 [0043]; fig 3), for covering a side opening for substantially blocking an amount of exterior light to be inserted within an interior space upon applying a camera on an adaptor and a subject's hand within said side opening (cover 18 may be hingedly attached to the housing 10 so as to facilitate insertion of the finger into the chamber 30… digital camera 40 of the host device 4, which will act as the digital sensor, is located inside of, and substantially enclosed within, chamber 30 when the apparatus housing 10 is deployed on the host device 4 [0044]; fig 4).
Segman is considered analogous art to the present invention because the invention is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective date to have modified the apparatus of Grubb in view of Choi such that it included a cover connected to the box, for covering the side opening for substantially blocking an amount of exterior light to be inserted within said interior space upon applying the camera on the adaptor and the subject's hand within said side opening as taught by Segman, because it would enclose the camera within in the box and block exterior light from interfering with capturing an image. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 10, Grubb in view of Choi teaches the invention as discussed above in claim 8. Grubb in view of Choi fails to teach a cover, connectable to the box, and adopted to cover the side opening for substantially blocking an amount of exterior light to be inserted within said interior space upon applying the camera on the adaptor and the subject's hand within said side opening.
However, Segman teaches a cover connectable to a box (the apparatus housing includes… a cover 18 [0043]; fig 3), and adopted to cover a side opening for substantially blocking an amount of exterior light to be inserted within an interior space upon applying a camera on an adaptor and a subject's hand within said side opening (cover 18 may be hingedly attached to the housing 10 so as to facilitate insertion of the finger into the chamber 30… digital camera 40 of the host device 4, which will act as the digital sensor, is located inside of, and substantially enclosed within, chamber 30 when the apparatus housing 10 is deployed on the host device 4 [0044]; fig 4).
It would have been obvious to one having ordinary skill in the art at the time of the effective date to have modified the apparatus of Grubb in view of Choi such that it included a cover, connectable to the box, and adopted to cover the side opening for substantially blocking an amount of exterior light to be inserted within said interior space upon applying the camera on the adaptor and the subject's hand within said side opening as taught by Segman, because it would enclose the camera within in the box and block exterior light from interfering with capturing an image. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grubb (WO 2018162732 A1 – previously cited) in view of Choi (EP 3685747 A1 – previously cited) as applied to claims 1 and 8 above, and further in view of Thangaraj et al. (US Patent Pub. No. 20140323832 – previously cited) hereinafter Thangaraj.
Regarding Claim 4, Grubb in view of Choi teaches the invention as discussed above in claim 1. Grubb in view of Choi fails to teach the maximum amount of exterior light to be captured by the camera is at most 1 lumen.
However, Thangaraj teaches taking a photo in the absence of exterior light (camera bellow 114 acts as a shield to camera 102, thereby preventing ambient light from entering into the field of image acquisition. The prevention of ambient light from entering into the field of image acquisition provides a controlled environment for acquiring image [0023]). It is noted that the absence/prevention of ambient light would result in exterior light captured by the camera being below 1 lumen.
Thangaraj is considered analogous art to the present invention because it is reasonably pertinent to a problem faced by the inventors.
It would have been obvious to one having ordinary skill in the art at the time of the effective date to have modified the apparatus of Grubb in view of Choi such that the maximum amount of exterior light to be captured by the camera is at most 1 lumen as taught by Thangaraj, because it would allow for a controlled environment for imaging. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grubb (WO 2018162732 A1 – previously cited) in view of Choi (EP 3685747 A1 – previously cited), in view of Li (US Patent Pub. No. 20190073763 – previously cited), in view of Castro-Gonzales et al. (US Patent. Pub. No. 20190139221 – previously cited) hereinafter Castro, and further in view of Mannino et al. (WO 2020096999 A1 – previously cited) hereinafter Mannino.
Regarding Claim 11, Grubb discloses a method for determining hemoglobin levels in a subject (a method of imaging blood within a target region of tissue (pg. 6, lines 6-7); Examiner notes the method can be configured to determine hemoglobin levels) in need thereof using an apparatus (apparatus for imaging blood within a target region of tissue (pg. 5, lines 12-13)), comprising:
(i) a box defining an interior space (apparatus 2 (pg. 10, line 32); fig 1) comprising:
(a) an upper opening adopted to allow a camera placed on top of the box, to capture images of a subject's hand placed inside the interior space (camera module 16 is… arranged to capture images of the back of the hand 7 placed on the base 6 below (pg. 11, lines 13-15); fig 1), wherein a vertical distance between the upper opening and a bottom of the box is between 50 to 400 mm (support platform 12 may be spaced from the base 6 by between 5cm and 100cm (pg. 11, lines 7-8); fig 1);
and (b) a side opening configured for an insertion of said subject's hand (fig 1);
(ii) an adaptor, attached to an upper face to the box, for holding the camera and ensuing a location of a lens of said camera above the upper opening (support frame 4 therefore holds the light source 14 and the camera module 16 in a fixed special relationship with respect to each other and the base 6 (pg. 11, lines 15-16); fig 1; Examiner notes support frame 4 performs the same function as an adaptor);
where in a field of view of said camera captures the nail and the skin (camera module 16 is… arranged to capture images of the back of the hand 7 placed on the base 6 below (pg. 11, lines 13-15); fig 1; Examiner notes nail and skin would be included in an image of the back of a hand).
and wherein the method executing program instructions, and wherein the program instructions comprise the following steps (a method of imaging blood within a target region of tissue comprising the steps of (pg. 3, lines 21-22)):
i. receiving an image from said camera captured under a defined light condition, the image comprising a plurality of nails and skin of the subject (While the hand is illuminated, the camera module 16 is controlled by the processor 24 to produce image data associated with a target region of tissue of the hand 7 which is within view of the camera module 16 and illuminated by the light source 14. (pg. 13, lines 6-9); fig 4).
Grubb fails to disclose discloses a method for determining hemoglobin levels in a subject in need thereof using an apparatus, comprising:
(iii) a placement pad located at a bottom of the box, having a texture configured to provide feedback to direct said subject to place a hand portion of said subject’s hand comprising a nail and a skin in a direction facing the lens;
and wherein the method executing program instructions, and wherein the program instructions comprise the following steps:
i. receiving an image from said camera captured under a defined light condition, the image comprising a plurality of nails and skin of the subject and a color scale bar;
ii. performing an image segmentation of pixels of nail portions of the image
iii. transforming image data into hemoglobin levels by trained neural network configured to process segmented nail portion pixels' and add a limitation specifying that the neural network is trained to correlate color data from the nail portions to hemoglobin concentration values;
and iv. outputting for display the hemoglobin level of the subject.
However, Choi teaches a placement pad (finger contact surface 112, on which a user's finger 10 is placed to come into contact with the finger contact surface 112 [0035]; figs 1-3), having a texture configured to provide feedback to direct a subject to consistently place a hand portion of said subject’s hand comprising a nail and a skin (texture unit 116 is formed at the finger contact surface 112 to allow a user to feel a tactile sensation on the finger 10 when the finger 10 is in contact with the finger contact surface 112 [0035]; The texture interface 110 for measuring a bio-signal may induce a user to place the finger 10 in the same position every time the user measures a bio-signal at different times, thereby improving reproducibility of the bio-signal. [0036]; figs 1-3).
It would have been obvious to one having ordinary skill in the art to have modified the method of Grubb such that the apparatus includes a placement pad located at a bottom of the box, having a texture configured to provide feedback to direct said subject to place a hand portion of said subject’s hand comprising a nail and a skin in a direction facing the lens as taught by Choi, because it would allow said subject to feel a tactile sensation when the hand portion is correctly positioned inside the box for accurate imaging. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Grubb in view of Choi fails to teach the method executing program instructions, and wherein the program instructions comprise the following steps:
i. receiving an image from said camera captured under a defined light condition, the image comprising a plurality of nails and skin of the subject and a color scale bar;
ii. performing an image segmentation of pixels of nail portions of the image
iii. transforming image data into hemoglobin levels by trained neural network configured to process segmented nail portion pixels' and add a limitation specifying that the neural network is trained to correlate color data from the nail portions to hemoglobin concentration values;
and iv. outputting for display the hemoglobin level of the subject.
However, Li teaches a color scale bar (a color pattern chart 180, as also shown in outline in FIGS. 1A and 1B [0050]; fig 2), wherein a field of view of a camera also captures the color scale bar (such that the red-green-blue base color calibration strip 210 is provided for use in calibrating the camera 162 [0052]).
It would have been obvious to one having ordinary skill in the art at the effective filing date to have modified the method of Grubb in view of Choi such that the received image comprises the color scale bar as taught by Li. Doing so would allow for calibration of the camera and improved measurements. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Grubb in view of Choi in view of Li fails to teach the method executing program instructions, and wherein the program instructions comprise the following steps:
ii. performing an image segmentation of pixels of nail portions of the image
iii. transforming image data into hemoglobin levels by trained neural network configured to process segmented nail portion pixels' and add a limitation specifying that the neural network is trained to correlate color data from the nail portions to hemoglobin concentration values;
and iv. outputting for display the hemoglobin level of the subject.
However, Castro teaches a method operates to execute program instructions (Methods described in earlier sections of this application can be encoded as processor executable instructions into the memory of smartphone 1320 [0152]), and comprises the following steps:
ii. performing an image segmentation of pixels of nail portions of the image (FIG. 3 is an example image of a human nailfold that may be used in the methods described above for the analysis of blood cell dynamics in one or more of the nailfold capillaries. [0096]; figs 14D, 17, 20, 22; At step 120 of method 100, capillary segmentation and/or profile extraction are performed. Capillary segmentation may be used to identify the segments of capillaries in either the original or the registered images (e.g., by identifying the boundaries of the capillary segments). Profile extraction may be used to extract pixel information within the capillary segments for further analysis. [0080]; Step 220 of method 200 in FIG. 2 is performed to achieve capillary profile segmentation [0105]; fig 1)
iii. transforming the image data into an event by trained neural network (FIG. 27A illustrates an example of event detected on a capillary video by… the neural network (bottom raw) [0039]).
Castro also teaches “it may be helpful to extract pixel information inside the capillary segments and set aside information in other areas in the images” [0080].
Castro is considered analogous art to the present invention because the invention is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Grubb in view of Choi in view of Li such that the method comprises performing an image segmentation of the pixels of the nail portions of the image and transforming the image data by trained neural network, as taught by Castro because it would differentiate between the pixel information that will be used to measure blood hemoglobin levels and other pixel information. Furthermore, it is well-understood, conventional, and routine activity in the art to use neural networks for image processing. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Grubb in view of Choi in view of Li, and further in view of Castro fails to teach the method executing program instructions, and wherein the program instructions comprise the following steps:
iii. transforming image data into hemoglobin levels by trained neural network configured to process segmented nail portion pixels' and add a limitation specifying that the neural network is trained to correlate color data from the nail portions to hemoglobin concentration values;
and iv. outputting for display the hemoglobin level of the subject.
However, Mannino teaches a method operates to execute program instructions (the logical operations described herein with respect to the various figures may be implemented (1) as a sequence of computer implemented acts or program modules (i.e., software) running on a computing device [0100]), and comprises the following steps:
iii. transforming image data into hemoglobin levels by trained neural network (image metadata/other image data may be used in the transform to the user’s approximate Hgb level [0073]; fig 1; further data collection will increase the size of the patient image pool, facilitating the incorporation of deep machine learning techniques to further refine the Hgb measurement algorithm [0057]; Examiner notes neural networks are a type of machine learning) configured to process segmented nail portion pixels' (In an example, each of the regions of interest is 900 pixels, corresponding to approximately 10mm2 on each fingernail. The number of pixels may vary depending on the resolution of the image sensor capturing the image. Color data is extracted from each region [0064]) and add a limitation specifying that the neural network is trained to correlate color data from the nail portions to hemoglobin concentration values (A Hgb determination algorithm uses robust multi-linear regression with a bisquare weighting algorithm to relate the image parameter data to manually measured CBC Hgb levels. [0064]; See Equation 1 in paragraph [0065]);
and iv. outputting for display the hemoglobin level of a subject (processor is further configured to output for display the user’s approximate Hgb level [0003]; fig 1).
Mannino is considered analogous art to the present invention because the invention is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Grubb in view of Choi in view of Li and further in view of Castro such that the method comprises transforming image data into hemoglobin levels by trained neural network configured to process segmented nail portion pixels' and add a limitation specifying that the neural network is trained to correlate color data from the nail portions to hemoglobin concentration values and outputting for display the hemoglobin level of the subject, as taught by Mannino. Using a trained neural network as taught by Castro to determine blood hemoglobin levels as taught by Mannino would have been obvious to one having ordinary skill in the art at the time of the effective date if one wanted to measure blood hemoglobin levels. Furthermore, outputting physiological data for display is well-understood, routine, and conventional activity in the art. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 12, Grubb in view of Choi in view of Li in view of Castro, and further in view of Mannino teaches the invention as discussed above in claim 11. Grubb in view of Choi in view of Li in view of Castro, and further in view of Mannino further teaches receiving as input a video from the camera (camera can be utilised to capture one or more images or videos (pg. 20, lines 21-22)).
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grubb (WO 2018162732 A1 – previously cited) in view of Choi (EP 3685747 A1 – previously cited) in view of Castro (US Patent. Pub. No. 20190139221 – previously cited), and further in view of Mannino (WO 2020096999 A1 – previously cited), as applied to claim 11 above, and further in view of Lee et al. (US Patent Pub. No. 20180199838 – previously cited) hereinafter Lee.
Regarding Claim 13, Grubb in view of Choi in view of Li in view of Castro, and further in view of Mannino teaches the invention as discussed above in claim 11. Grubb in view of Choi in view of Li in view of Castro, and further in view of Mannino fails to teach analyzing a heart rate of the subject from said video.
However, Lee teaches analyzing a heart rate of a subject from a video (FIG. 2, a flowchart for a method for camera-based heart rate tracking 200 [0064]). Lee also teaches “HC is particularly indicative of heart rate” [0042] and “a greater level of accuracy can be achieved for making predictions of HC changes, and as described making predictions of heart rate, because employing bitplanes provides a greater data basis for training the machine learning model” [0043].
Lee is considered analogous art to the present invention because the invention is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art to have modified the method of Grubb in view of Choi in view of Li in view of Castro, and further in view of Mannino such that the method includes analyzing a heart rate of the subject from said video, as taught by Lee. Using bitplanes to measure blood hemoglobin levels and heart rate leads to improved accuracy and thus would improve the method of Grubb in view of Choi in view of Li in view of Castro, and further in view of Mannino. Furthermore, it is well-understood, routine, and conventional activity to measure heart rate along with blood hemoglobin levels as taught Lee.
Regarding Claim 14, Grubb in view of Choi in view of Li in view of Castro, and further in view of Mannino teaches the invention as discussed above in claim 11. Grubb in view of Choi in view of Li in view of Castro, and further in view of Mannino fails to teach receiving as input one or more parameters of the subject selected from of the group consisting of. age, gender, and heart rate.
However, Lee teaches analyzing a heart rate of a subject from a video (FIG. 2, a flowchart for a method for camera-based heart rate tracking 200 [0064]). Lee also teaches “HC is particularly indicative of heart rate” [0042] and “a greater level of accuracy can be achieved for making predictions of HC changes, and as described making predictions of heart rate, because employing bitplanes provides a greater data basis for training the machine learning model” [0043].
It would have been obvious to one having ordinary skill in the art to have modified the method of Grubb in view of Choi in view of Li in view of Castro, and further in view of Mannino such that the method includes receiving as input a heart rate of the subject, as taught by Lee. Using bitplanes to measure blood hemoglobin levels and heart rate leads to improved accuracy and thus would improve the method of Grubb in view of Choi in view of Li in view of Castro, and further in view of Mannino. Furthermore, it is well-understood, routine, and conventional activity to measure heart rate along with blood hemoglobin levels as taught by Lee.
Response to Arguments
Applicant’s arguments, see page 14 of Remarks, filed 11/24/2025, with respect to the drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments, see page 14 of Remarks, filed 11/24/2025, with respect to the specification objections have been fully considered and are persuasive. The specification objections have been withdrawn.
Applicant’s arguments, see page 15 of Remarks, filed 11/24/2025, with respect to the claim objections have been fully considered and are persuasive. The claim objections have been withdrawn. However, upon further consideration, a new ground(s) of objection is made in view of Applicant’s amendments.
Applicant’s arguments, see pages 15-16 of Remarks, filed 11/24/2025, with respect to the 112(a) rejections for claims 11-12 and 14-15 have been fully considered and are persuasive. The 112(a) rejections for claims 11-12 and 14-15 have been withdrawn.
Applicant’s arguments, see pages 15-16 of Remarks, filed 11/24/2025, with respect to the 112(a) rejection for claim 13 has been fully considered and are not persuasive. Applicant argues that “the specification provides adequate written description for analyzing heart rate from video data.” However, Applicant has failed to specifically point any paragraphs which do so. Furthermore, as stated in the Non-Final Rejection, filed 07/10/2025, the specification simply restates the claim language and fails to provide any details as to how video is analyzed to determine heart rate. Considering analyzing heart rate from video data is not well-understood, routine, and conventional activity in the art, the 112(a) rejection for claim 13 is maintained.
Applicant’s arguments, see page 16 of Remarks, filed 11/24/2025, with respect to the 112(b) rejection(s) of claim(s) 1, 3-6, 8, and 10 have been fully considered and are persuasive. Applicant’s arguments with respect to the 112(b) rejection for claim 15 has been fully considered and is moot because claim 15 was canceled. Therefore, the rejections have been withdrawn. Applicant’s arguments with respect to the 112(b) rejections of claims 2, 7, 9, and 11-14 have been fully considered and are not persuasive. Applicant failed to fully address the indefiniteness issues in the aforementioned claims. Therefore, the 112(b) rejections of claims 2, 7, 9, and 11-14 have been maintained. Upon further consideration, a new grounds of rejection for claims 1, 8, and 11 is applied in view of Applicant’s amendments.
Applicant's arguments, see pages 17-19 of Remarks, filed 11/24/2025, with respect to the prior art rejections have been fully considered but they are not persuasive. Applicant argues “Choi's texture unit is designed for a completely different purpose and configuration than what is claimed.” Thus, “the combination of Grubb and Choi fails to teach or suggest this specific functional arrangement where tactile feedback is used to consistently position a particular anatomical landmark for haemoglobin level determination through nail imaging.” Examiner respectfully disagrees. Choi teaches a texture unit that allows a user to feel if his/her finger has made appropriate contact with a sensor and allows a user to place his/her finger in roughly the same position. It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified Grubb such that the apparatus includes a placement pad located at a bottom of the box, having a texture configured to provide feedback to direct said subject to place a hand portion of said subject’s hand comprising a nail and a skin in a direction facing the lens because Choi teaches using texture to guide placement of a body part in order to obtain some form of data. Therefore, the combination of Grubb and Choi teaches the specific functional arrangement for use in determining hemoglobin levels.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANKI M BAVA whose telephone number is (571)272-0416. The examiner can normally be reached Monday-Friday 9:00-6:00 ET.
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/JANKI M BAVA/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791