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 .
Information Disclosure Statement
1. The information disclosure statement (IDS) submitted on 12/13/24 has been entered. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings/Specification
2. The drawings/specification filed on 12/13/24 are objected because some elements in the claims are not described clearly in drawings/specification. Current claims 1, 2, 12, 13, disclose “at the optical objective, a central axis of the first light is not parallel to a central axis of light that passes to the first electronic detector … a central axis of the second light is not parallel to a central axis of light that passes to a second electronic detector”. However, current drawings/specification do not disclose which light is the first light or second light or the second light, which detector is the first electronic detector or the second electronic detector, and what axis is a central axis of light that passes to the first electronic detector or passes to the second electronic detector, and what axis is central axis of the first light or of the second light.
Appropriate correction is required.
Double Patenting
3. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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4. Claims 1-22 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-40 of Durr et al. (U.S. Patent No. 12,203,924), in view of Groner et al. (U.S. Pat. No. 6,104,939), or in view of Zalevsky (U.S. Pub. No. 2009/0122299). Hereafter, “Durr ‘924”, “Groner”, “Zalevsky”.
As to claim 1, Durr ‘924 claims a system for label-free determination of a value of at least one blood property (claim 1, lines 1-2), the system comprising:
an optical objective comprising at least one lens (claim 1, line 3);
at least a first light source situated so as to provide first light to a body part (claim 1, lines 4-5);
at least a first electronic detector situated to receive light gathered by the optical objective and generate image data (claim 1, lines 14-16);
at least one electronic processor communicatively coupled to the first electronic detector, the at least one electronic processor configured to determine the value of the at least one blood property based at least in part on the image data (claim 1, lines 17-21), at the optical objective (claim 1, lines 14-16); and
an output interface communicatively coupled to the at least one electronic processor and configured to provide the value of the at least one blood property (claim 1, lines 22-24).
However, Durr ‘924 does not claim a central axis of the first light is not parallel to a central axis of light that passes to the first electronic detector. Groner discloses a central axis of the first light is not parallel to a central axis of light that passes to the first electronic detector (figure 15B, a central axis of the first light of light source 1502 is not parallel to a central axis of light that passes to the first electronic detector 1560). Moreover, Zalevsky also discloses a central axis of the first light is not parallel to a central axis of light that passes to the first electronic detector (the following figure 1, and figure 2, at the optical objective 108, a central axis C of the first light 113 is not parallel to a central axis D of light that passes to the first electronic detector of spectrometer 103). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to modify Durr ‘924 by having a central axis of the first light is not parallel to a central axis of light that passes to the first electronic detector; in order to have different detectors located at different locations to detect different reflected light beams.
As to claim 2, Durr ‘924 claims a second light source situated so as to provide second light to the body part, wherein, at the optical objective, a central axis of the second light is not parallel to a central axis of light that passes to a second electronic detector, wherein a wavelength of the first light is different from a wavelength of the second light by an amount sufficient for the first light and the second light to be split by a dichroic mirror (claim 1, lines 7-13. Note: a central axis of the second light is not parallel to a central axis of light that passes to a second electronic detector is not different from off-center from the central axis of the optical objective).
As to claim 3, Durr ‘924 claims the at least one blood property comprises a rate of change of a quantifiable blood property (claim 2).
As to claim 4, Durr ‘924 claims the at least one blood property comprises a count of, or ratio comprising, at least one of: red blood cells, platelets, lymphocytes, neutrophils, lymphocytes, monocytes, eosinophils, or basophils (claim 3).
As to claim 5, Durr ‘924 claims the at least one blood property comprises at least one of: heart rate or blood oxygenation (claim 4).
As to claim 6, Durr ‘924 claims a machine learning classifier trained to identify in the image data at least one of: red blood cells, platelets, lymphocytes, neutrophils, lymphocytes, monocytes, eosinophils, or basophils (claim 5).
As to claim 7, Durr ‘924 claims the body part comprises a lingual frenulum (claim 6).
As to claim 8, Durr ‘924 claims the at least a first light source is situated to provide the first light to the body part through the optical objective (claim 7).
As to claim 9, Durr ‘924 claims an annulus comprising at least two vacuum interfaces configured to adhere the annulus to a body part using at least one air pressure differential, wherein the optical objective is situated so as to gather light from the body part through a central opening of the annulus (claim9).
As to claim 10, Durr ‘924 claims a temperature sensor situated on the annulus and communicatively coupled to the at least one electronic processor, wherein the at least one electronic processor is further configured to determine a temperature from a signal received from the temperature sensor (claim 9).
As to claim 11, Durr ‘924 claims the at least two vacuum interfaces are configured to adjust a lateral position of the annulus on the body part by applying different air pressure differentials to different vacuum interfaces (claim 10).
As to claim 12, Durr ‘924 claims a method for label-free determination of a value of at least one blood property (claim 11, lines 1-2), the system comprising:
an optical objective comprising at least one lens (claim 11, line 5);
at least a first light source situated so as to provide first light to a body part (claim 11, lines 6-7);
at least a first electronic detector situated to receive light gathered by the optical objective and generate image data (claim 11, lines 17-19);
at least one electronic processor communicatively coupled to the first electronic detector, the at least one electronic processor configured to determine the value of the at least one blood property based at least in part on the image data (claim 11, lines 20-24), at the optical objective (claim 11, lines 5); and
an output interface communicatively coupled to the at least one electronic processor and configured to provide the value of the at least one blood property (claim 11, lines 25-28).
However, Durr ‘924 does not claim a central axis of the first light is not parallel to a central axis of light that passes to the first electronic detector. Groner discloses a central axis of the first light is not parallel to a central axis of light that passes to the first electronic detector (figure 15B, a central axis of the first light of light source 1502 is not parallel to a central axis of light that passes to the first electronic detector 1560). Moreover, Zalevsky also discloses a central axis of the first light is not parallel to a central axis of light that passes to the first electronic detector (the following figure 1, and figure 2, at the optical objective 108, a central axis C of the first light 113 is not parallel to a central axis D of light that passes to the first electronic detector of spectrometer 103). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to modify Durr ‘924 by having a central axis of the first light is not parallel to a central axis of light that passes to the first electronic detector; in order to have different detectors located at different locations to detect different reflected light beams.
As to claim 13, Durr ‘924 claims the device further comprises a second light source situated to provide second light to the body part, wherein, at the optical objective, wherein a wavelength of the first light is different from a wavelength of the second light by an amount sufficient for the first light and the second light to be split by a dichroic mirror (claim 22). However, Durr ‘924 does not claim a central axis of the second light is not parallel to a central axis of light that passes to the second electronic detector. Groner discloses a central axis of the second light is not parallel to a central axis of light that passes to the second electronic detector (figure 15B, a central axis of light path 1507 of the second light of light source 1502 is not parallel to a central axis of light that passes to the second electronic detector 1570). Moreover, Zalevsky also discloses a central axis of the second light is not parallel to a central axis of light that passes to the second electronic detector (the following figure 1, and figure 2, at the optical objective 108, a central axis of the first light 106 is not parallel to a central axis D of light that passes to the second electronic detector camera 111). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to modify Durr ‘924 by having a central axis of the second light is not parallel to a central axis of light that passes to the second electronic detector; in order to have different detectors located at different locations to detect different reflected light beams.
As to claim 14, Durr ‘924 claims the at least one blood property comprises a rate of change of a quantifiable blood property (claim 12).
As to claim 15, Durr ‘924 claims the at least one blood property comprises a count of, or ratio comprising, at least one of: red blood cells, platelets, lymphocytes, neutrophils, lymphocytes, monocytes, eosinophils, or basophils (claim13).
As to claim 16, Durr ‘924 claims at least one blood property comprises at least one of: heart rate or blood oxygenation (claim 14).
As to claim 17, Durr ‘924 claims a machine learning classifier trained to identify in the image data at least one of: red blood cells, platelets, lymphocytes, neutrophils, lymphocytes, monocytes, eosinophils, or basophils (claim 13).
As to claim 18, Durr ‘924 claims the body part comprises a lingual frenulum (claim 16).
As to claim 19, Durr ‘924 claims the at least a first light source is situated to provide the first light to the body part through the optical objective (claim 17).
As to claim 20, Durr ‘924 claims an annulus comprising at least two vacuum interfaces configured to adhere the annulus to a body part using at least one air pressure differential, wherein the optical objective is situated so as to gather light from the body part through a central opening of the annulus (claim 20).
As to claim 21, Durr ‘924 claims a temperature sensor situated on the annulus and communicatively coupled to the at least one electronic processor, wherein the at least one electronic processor is further configured to determine a temperature from a signal received from the temperature sensor (claim 19).
As to claim 22, Durr ‘924 claims the at least two vacuum interfaces are configured to adjust a lateral position of the annulus on the body part by applying different air pressure differentials to different vacuum interfaces (claim 20).
Claim Rejections - 35 USC § 103
5. 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 of this title, 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.
6. Claim(s) 1-2, 8, 12-13, 19, is/are rejected under 35 U.S.C. 103 as being unpatentable over Rensen et al. (Pub. No. 2007/0070328) in view of Zalevsky (U.S. Pub. No. 2009/0122299). Hereafter “Rensen”, “Zalevsky”
Regarding Claim(s) 1-2, Rensen teaches a system/method for label-free determination of a value of at least one blood property, the system comprising:
an optical objective comprising at least one lens (figure 1, objective 108);
at least a first light source situated so as to provide light to a body part (figure 2, and the following figure 1, a first light source 101; a body part 114, 112, 110; light beam A);
at least a first electronic detector situated to receive light gathered by the optical objective and generate image data (figures 1, 2, it is inherent that spectrometer 103, to receive light gathered by the optical objective 108, has its own electronic detector), wherein, at the optical objective, a central axis of the first light is not parallel to a central axis of light that passes to the first electronic detector (the following figure 1, and figure 2, , at the optical objective 108, a central axis C of the first light 113 is not parallel to a central axis D of light that passes to the first electronic detector of spectrometer 103);
at least one electronic processor communicatively coupled to the first electronic detector, the at least one electronic processor configured to determine the value of the at least one blood property based at least in part on the image data ([0005, 0006, 0029, 0031,0032, 0037, 0043, 0044, 0060-0062, 0064]); and
However, Rensen does not teach to determine output interface communicatively coupled to the at least one electronic processor and configured to provide the value of the at least one blood property, and obtaining a reading from the output interface. Zalevsky teaches this limitation ([0058, 0060]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to modify Rensen by generating output data from the image data; in order to indicative the blood parameters calculated from the image data ([0058]).
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Regarding Claim(s) 2, 13, Rensen in view of Zalevsky disclose a system/method according to claims 1, 12, as stated above except for a second light source situated so as to provide second light to the body part, wherein, at the optical objective, a central axis of the second light is not parallel to a central axis of light that passes to a second electronic detector, wherein a wavelength of the first light is different from a wavelength of the second light by an amount sufficient for the first light and the second light to be split by a dichroic mirror. Rensen further discloses a second light source situated so as to provide second light to the body part, wherein, at the optical objective, a central axis of the second light is not parallel to a central axis of light that passes to a second electronic detector, wherein a wavelength of the first light is different from a wavelength of the second light by an amount sufficient for the first light and the second light to be split by a dichroic mirror (figure 1, at the optical objective 108, a central axis of the second light 106 is not parallel to a central axis of light 118 that passes to a second electronic detector 111, wherein a wavelength of the first light 116 is different from a wavelength of the second light 106by an amount sufficient for the first light and the second light to be split by a dichroic mirror 115).
Regarding Claim(s) 8, 19, Rensen in view of Zalevsky disclose a system/method according to claims 1, 12, as stated above except for the at least a first light source is situated to provide the first light to the body part through the optical objective. Rensen further discloses a first light source is situated to provide light to the body part through the objective (figures 1-2, objective 108, body part elements 112, 114).
7. Claim(s) 3, 14, is/are rejected under 35 U.S.C. 103 as being unpatentable over Rensen et al. (Pub. No. 2007/0070328) in view of Zalevsky (U.S. Pub. No. 2009/0122299), further in view of Endo (U.S. Pub. No. 2018/0214009). Hereafter “Rensen”, “Zalevsky”, “Endo”.
Regarding Claims 3, 14, Rensen in view of Zalevsky disclose a system/method according to claims 1, 12, as stated above except for the at least one blood property comprises a rate of change of a quantifiable blood property. Endo teaches a rate of change of a quantifiable blood property, ([0062, 0065, 0070, 0108]). It would have been obvious to one having ordinary skill in the art at the time of the invention was made to modify Rensen and Zalevsky by having a rate of change of a quantifiable blood property in order to extract from the endoscope image obtained by the subsequent new examination with respect to the thickness of the blood vessel extracted from the endoscope image obtained by the past.
8. Claim(s) 4-6, 15-17, is/are rejected under 35 U.S.C. 103 as being unpatentable over Rensen et al. (Pub. No. 2007/0070328) in view of Zalevsky (U.S. Pub. No. 2009/0122299), further in view of Sato (U.S. Pub. No. 2020/0126664). Hereafter “Rensen”, “Zalevsky”, “Sato”.
Regarding Claim 4-6, 15-17, Rensen in view of Zalevsky disclose a system/method according to claims 1, 12, as stated above except for a count of, or ratio comprising, of at least one of: red blood cells, platelets, lymphocytes, neutrophils, lymphocytes, monocytes, eosinophils, or basophils, and heart rate or blood oxygenation. Sato teaches this limitation, ([0089, 0122]). It would have been obvious to one having ordinary skill in the art at the time of the invention was made to modify Rensen and Zalevsky by having count of, or ratio, and heart rate or blood oxygenation, in order to count a specific component within the blood stream.
9. Claim(s) 7, 18, is/are rejected under 35 U.S.C. 103 as being unpatentable over Rensen et al. (Pub. No. 2007/0070328) in view of Zalevsky (U.S. Pub. No. 2009/0122299), further in view of Steuer et al. (U.S. Pub. No. 2019/0392953). Hereafter “Rensen”, “Zalevsky”, “Steuer”.
Regarding Claims 7, 18, Rensen in view of Zalevsky disclose a system/method according to claims 1, 12, as stated above except for a lingual frenulum. Steuer teaches this limitation, ([0103]). It would have been obvious to one having ordinary skill in the art at the time of the invention was made to modify Rensen and Zalevsky by having a lingual frenulum, in order to inspect a specific sample such as a lingual frenulum.
Allowable Subject Matter
10. Claims 9-11, 20-22, are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
11. The following is a statement of reasons for the indication of allowable subject matter: there was no prior art found by the examiner that suggested modification or combination with the cited art so as to satisfy the combination of all the limitations in claims 9, 20.
12. As claims 9, 20, the prior art of record taken alone or in combination, fails to disclose or render obvious a system/method for label-free determination of a value of at least one blood property comprising a first light source situated so as to provide light to a body part at a location that is off-center from a central axis of the objective; determining the value of the at least one blood property based at least in part on the image data; and an output interface to provide the value of the at least one blood property; an annulus comprising at least two vacuum interfaces configured to adhere the annulus to a body part using at least one air pressure differential, wherein the optical objective is situated so as to gather light from the body part through a central opening of the annulus; in combination with the rest of the limitations of claims 1 and 9, or 12 and 20.
Fax/Telephone Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRI T TON whose telephone number is (571)272-9064. The examiner can normally be reached on 8am-4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michelle Iacoletti can be reached on (571)270-5789. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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June 17, 2026
/Tri T Ton/
Primary Examiner Art Unit 2877
Prosecution Insights