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 arguments
The amendment filled on 01/30/2026 has been entered. Claims 1-31 are remain pending in the application.
Applicant’s arguments, see Page 9, filed 01/30/2026, with respect to claim objection have been fully considered and are persuasive. Accordingly, the claim objection of Claim 16 have been withdrawn.
Applicant’s arguments, see Page 9, filed 01/30/2026, with respect to 35 U.S.C § 112(b) for the term “preferably” have been fully considered and are persuasive. Accordingly, the claim rejection of 35 U.S.C § 112(b) of Claims 2, 5, 7, 14-20 and 29, have been withdrawn.
Applicant’s arguments, see Page 9, filed 01/30/2026, with respect to 35 U.S.C § 112(a), 35 U.S.C § 112(b) and Claim interpretation under 35 U.S.C. 112(f) for the elements (“a processing system”, in claim 10, “a monitoring system “, in claim 10, “means for synchronize” in claims 10 and 22) have been fully considered and are persuasive. Accordingly, the claim rejection of 35 U.S.C § 112(a), 35 U.S.C § 112(b) of Claim 10-21, 23-29 and Claim interpretation under 35 U.S.C. 112(f) have been withdrawn.
However, in regard to the element “means for modifying” in claim 22 was not traversed or amended. Therefore, the claim interpretation under 35 U.S.C. 112(f), 35 U.S.C § 112(a), 35 U.S.C § 112(b) for element “means for modifying” in claim 22 as explained in the previous office action is maintained.
Applicant's arguments under 35 U.S.C § 103:
In page 11, applicant argues that “Barrett performs optical measurement in a blood chamber- separate from the tubing – having a substantially flat viewing region with opposing lenses, and calculates hematocrit from optical signals generated in that chamber. Barrett does not disclose modifying emission power as a function of a calculated hematocrit or hemoglobin level. Significantly, Applicant respectfully submits that Barrett does not qualify as prior art for the claimed invention because Barrett does not disclose or suggest measurement of "fluid circulating in a tubular portion" as required by independent claims 1 and 10.
In pages 11-12, applicant argues that “Barrett Requires a Separate Blood Chamber Structure”.
In page 13, applicant argues that “The Claimed Invention Measures Directly in Tubular Portions”.
In pages 13-14, applicant argues that “This Distinction Is Not Mere Semantics-It Reflects Different Inventions”.
In pages 14-15, applicant argues that “Barrett's Approach Teaches Away from Direct Measurement in Tubing”.
In page 15, applicant argues that “Heinemann adjusts light-source intensity to maintain substantially constant detected intensity at a photodetector. The feedback loop is driven by detector output, not by a calculated physiological parameter, and therefore serves a different control purpose.
In page 15, applicant argues that “Neither reference, alone or in combination, teaches or suggests: calculating hematocrit or hemoglobin, and then modifying emission power as a function of that calculated value during the determination, as now expressly recited in independent claims 1, 10, 30, and 31. The proposed combination requires hindsight reconstruction and lacks a teaching, suggestion, or motivation to control emission power based on a calculated hematocrit or hemoglobin level.”.
Examiner response to arguments under 35 U.S.C § 103:
In response to applicant’s arguments mention above regarding (a) , the examiner respectfully disagrees since Applicant’s arguments rely on language solely recited in preamble recitations in claim(s) 1 and 10. When reading the preamble in the context of the entire claim, the recitation "fluid circulating in a tubular portion" is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02. Additionally a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Moreover as cited in the previous office action in [0041-0042], the fluid circulated in a tubular portion as in element 18 and 32. Furthermore, in Claim 1 comprise the limitation “”the light source is modified during the determination of the hematocrit level”. Also, claim 10 comprise the limitation “modify the emission power of the light source as a function of the hematocrit level”, no after the determination of the hematocrit level as argued by the Applicant. Therefore, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant’s arguments mention above regarding (b), the examiner respectfully disagrees since applicant’s arguments rely that element 32 is a blood chamber and is not a tubular portion. As well it appear that Applicant missed that in the previous office action the tubular portion is indicated as (Fig. 1 element 32) in the fluid circulation area (Fig. 1 element 18). Moreover, the limitation “tubular portion” as a Positas comprehend is a description of the shape of the portion that as can see in Fig. 2 element 32 comprises shape and structures of a tubular portion, such as arguments that “tubular portion” can just be interpreted as a tube or tubing is incorrect. Additionally, the limitation “tubular portion” do not preclude element 32 to comprise windows or any additional element if at minimum comprises a “tubular portion”.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., This is fundamentally different from measuring fluid directly "in a tubular portion.") that is not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Such as, claimed language do not comprise “measuring directly in a tubular portion”.
In response to applicant’s arguments mention above regarding (c), the examiner respectfully disagrees of applicant's argument of the references fail to show certain features of the invention, since it is noted that the features upon which applicant relies (i.e., measuring fluid directly "in a tubing") are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Such as, claimed language do not comprise the limitations “measuring directly” and/or “tubing”.
In response to applicant’s arguments including cited preambles of claims 1 and 10, the examiner respectfully disagrees as explained above section (I and II).
Moreover, even though that the examiner agree that element 32 function as chamber, this chamber 32 comprises a tubular portion as shown in Fig. 2 and the claimed language do not preclude the tubular portion to be, comprise or function as a chamber.
In response to applicant’s arguments mention above regarding (d), the examiner respectfully disagrees of applicant's argument of the references fail to show certain features of the invention, since it is noted that the features upon which applicant relies (i.e., “measuring directly in tubing”), are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Such as, claimed language do not comprise the limitations “measuring directly” and/or “tubing”. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
In response to applicant’s arguments mention above regarding (e), examiner respectfully disagrees since Applicant’s arguments rely only on “measuring directly in tubular portion” that as explained above sections (I, II, III and IV) the examiner respectfully disagrees since it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Moreover, as cited in [0041-0042] of Barret, of claimed language “the emission of light beams in the direction of the tubular portion”, such as the emission in the direction of the tubular portion of chamber 32 and element 18. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies ( section e) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant’s arguments mention above regarding (f), examiner respectfully disagrees since as cited in the previous office action the modification is perform by element 35 “signal correction network” and since the light is interacting with the hematocrit in the sample as it level. Also, the light intensity is affected by the hematocrit level in the sample, such as the signal correction network modify the emission power of the light sources 27 + 29 as a function/relation of the hematocrit level. Additionally, as cited in the previous office action “the hematocrit or other blood parameter signal is related to the driving signal or current signal applied to the light source to generate the light intensity of the source”, [Col. 3, lines 6-22]) and “The feedback loop is responsive to the intensity of the light received by the signal detector to provide a feedback signal for adjusting the intensity of the light source so that the intensity of the light received by the signal detector is substantially constant over a range of values of the blood parameter. Means responsive to the feedback signal provides an output signal which provides an indication of the hematocrit. The feedback loop provides for accurate control of the light source.”, [Col. 2, lines 3-18], Heinemann. Moreover, the feedback signal derived from the infrared light source is linearly related to hematocrit, therefore the modification of the power of the light sources is perform as a function of the hematocrit level, [Col. 5, lines 42-66], Heinemann.
In response to applicant’s arguments mention above regarding (f), the examiner respectfully disagrees as explained above section (I-VI). Additionally, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Claim Objections
Claim 30 is objected to because of the following informalities:
In claim 30, line 1, “hematocrit leval” should be changed to —hematocrit level—.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 8-13 and 20-25 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Barrett et al. (US 2020/0353150 A1), hereafter Barrett in view of Heinemann et al. (US 5291884 A), hereafter Heinemann.
Regarding claims 1 and 10, Barret teaches an apparatus (Fig. 1 element 100) and method for determining the hematocrit level and/or the hemoglobin level of a fluid circulating in a tubular portion (Fig. 1 element 18, [0041-0042], Additionally, the term " for determining … tubular portion" in the preamble merely designates an intended use which does not carry enough weight so as to patentably distinguish from the cited prior art See MPEP 2111.02), comprising:
two transceiver assemblies (Figs. 1-4 elements 34 + 32), each transceiver assembly comprising a light source and a light sensor, (elements 34 “sensor clip assembly” comprise a LED emitter arm 344 that contains at least two LEDs and a photodetector arm 346 that contains at least two photodetectors, [0045], Therefore, Fig. 3 element 34 is interpreted as two transceiver assemblies) provided to be arranged on either side of the tubular portion (Fig. 1 element 32) at a fluid circulation area (Fig. 1 element 18) for a measurement in transmission, (“blood chamber 32 is preferably located in line with the extracorporeal tubing 18 upstream of the dialyzer 22 “, “determine the patient's real-time hematocrit value and oxygen saturation value”, [0042]);
the light source of each of the two transceiver assemblies (Fig. 1 element 34) being configured to emit light beams according to an emission wavelength chosen to correspond to an isosbestic point of hemoglobin; (the light sources generate light at 810 nm and 1300 nm, [0042] that is the isosbestic point to determine hematocrit and/or hemoglobin, [0045, 0058]).
a processing system comprising a at least one processor (Fig. 5 element 150) programmed to determine the hematocrit level and/or the hemoglobin level of the fluid as a function of the light signals received by the light sensors of the transceiver assemblies ( as shown in Fig. 5 element 34 comprise element 150 that calculates the hematocrit, oxygen saturation, and change in blood volume associated with blood passing through the blood chamber 32 to which the sensor clip assembly 34 is attached based on the raw data and calibration parameters, using a ratio metric model, [0049, 0056); and a monitoring system comprising a controller (Fig. 8 element 150 + 182).
Even though Barrett teaches a monitoring system comprising a controller (Fig. 8 element 150 + 182) that control the power emitted by the light sources, [0064], Barret is silent about a monitoring system comprising a controller configure to modify the emission power of the light sources as a function of the hematocrit level and/or the hemoglobin level determined for the fluid.
However, Heinemann related to optical measurement system and thus from the same field of endeavor teaches a monitoring system comprising a controller (Fig. 1 element 35, [col. 5, lines 28-31]) configured to modify the emission power of the light sources (Fig. 1 elements 27 + 29) as a function of the hematocrit level and/or the hemoglobin level determined for the fluid., (the device comprise a feedback loop that provide a feedback of the intensity of the first and second light sources and hematocrit that is used to adjust the intensity of the light sources based on the feedback [Col. 2, lines 3-18] and [Col. 3, lines 6-22]).
Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Barrett by including a monitoring system comprising a controller configured to modify the emission power of the light sources as a function of the hematocrit level and/or the hemoglobin level determined for the fluid (as taught by Heinemann) for several advantages such as: the first and second light sources are controlled directly by the light intensity at the signal detector, and this provides greater control over the light sources and improved accuracy of the device, [Col, 2, lines 57-60], Heinemann).
Regarding claim 2, Barrett in the combination outlined above teaches the apparatus of claim 1.
Barret is silent about wherein the emission power used for the light sources is comprised between 10% and 60% of the maximum emission power of said light sources.
However, Heinemann further teaches adjusting the intensity of the light source based on feedback, [Col. 2, lines 3-18] and [Col. 3, lines 6-22]). Therefore, a person having ordinary skill in the art before the effective filing date of the claimed invention would reasonably arrive at the conclusion that, since the device is able to adjust the intensity of the light source it would be obvious to adjust the emission power between 10% and 60% since it has been held that to be a prima facie case of obviousness that the normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages (see MPEP 2144.05 Section II-A).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify emission power (as taught by the combination of Heineman) with a specific emission power used for the light sources between 10% and 60% of the maximum emission power of said light sources as result of routine optimization as to optimized the dynamic range of the measuring device thus allowing to prevent signal saturation or producing unusable, noisy data, thus increase efficiency of the measurement process, (see MPEP 2144.05).
Regarding claim 3, Barrett in the combination outlined above teaches the apparatus of claim 1.
Barrett further teaches wherein the emission power of the light sources is monitored independently for each of the light sources, [0063-0064].
Regarding claim 8, Barrett in the combination outlined above teaches the apparatus of claim 1.
Barrett is silent about wherein the emission power of the light sources is modified during the determination of the hematocrit level and/or the hemoglobin level depending on the presence or absence of fluid in the tubular portion and/or on the nature of said fluid.
However, Heinemann further teaches wherein the emission power of the light sources is modified during the determination of the hematocrit level and/or the hemoglobin level depending on the presence or absence of fluid in the tubular portion and/or on the nature of said fluid, (an adjustment is accomplished by variably energizing the light sources. With this arrangement, the hematocrit or other blood parameter signal is related to the driving signal or current signal applied to the light source to generate the light intensity of the source, [Col. 2, lines 3-18] and [Col. 3, lines 6-22]).
Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Barrett by including a wherein the emission power of the light sources is modified during the determination of the hematocrit level and/or the hemoglobin level depending on the presence or absence of fluid in the tubular portion and/or on the nature of said fluid (as taught by Heinemann) for several advantages such as: the first and second light sources are controlled directly by the light intensity at the signal detector, and this provides greater control over the light sources and improved accuracy of the device, [Col, 2, lines 57-60], Heinemann).
Regarding claim 9, Barrett in the combination outlined above teaches the apparatus of claim 1.
Barrett is silent about wherein the light sources are monitored to emit light beams concomitantly.
However, Heinemann further teaches wherein the light sources (Fig. 1 elements 27 + 29) are monitored to emit light beams concomitantly, [Col. 5, lines 16-30], [Col. 3, lines 6-22]).
Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Barrett by including wherein the light sources are monitored to emit light beams concomitantly, (as taught by Heinemann) for several advantages such as: the first and second light sources are controlled directly by the light intensity at the signal detector, and this provides greater control over the light sources and improved accuracy of the device, [Col, 2, lines 57-60], Heinemann).
Regarding claim 11, Barrett in the combination outlined above teaches the apparatus of claim 10.
Barrett further teaches a support assembly (Fig. 34 “casing”, [0045]) on which the two transceiver assemblies are mounted, (element 34 comprise a casing where elements 344 + 346 are mounted that also comprise the bridge 348, [0045]), the support assembly being configured to be positioned around the tubular portion, ( as shown in Fig. 4 the casing of elements 344 + 346 and element 348 are positioned around element 32).
Regarding claim 12, Barrett in the combination outlined above teaches the apparatus of claim 10.
Barrett further teaches wherein the respective light sources of the two transceiver assemblies (Fig. 4 element 34) are configured to emit light beams at two different emission wavelengths, (“The LED emitter arm 344 contains an emitter subassembly with at least two LED emitters, one emitting infrared light radiation at a first wavelength (λ.sub.1) of about 1300 nm and another emitting infrared light radiation at a second wavelength (λ.sub.2) of about 810 nm.”, [0045]).
Regarding claim 13, Barrett in the combination outlined above teaches the apparatus of claim 10.
Barrett further teaches wherein at least one of the light sources of the transceiver assemblies is configured to emit light beams according to an emission wavelength chosen for an absorption of the light beams substantially identical in water or in plasma, (one of the LEDs photoemitters emit a light at 1300 nm chosen for absorption in water, [0042, 0075]).
Regarding claim 20, Barrett in the combination outlined above teaches the apparatus of claim 10.
Berrett further teaches wherein the light source of a first of the two transceiver assemblies is configured to emit light beams at a wavelength comprised between 780 nm and 840 nm, (the first light source generate light at 810 nm, [0042]) and
the light source of a second of the two transceiver assemblies is configured to emit light beams at a wavelength comprised between 1,270 nm and 1,330 nm, (the second light source generate light at 1300 nm, [0042]).
Regarding claim 21, Barrett in the combination outlined above teaches the apparatus of claim 10.
Barrett further teaches wherein the light sources of the transceiver assemblies (Figs. 1-4 elements 34 + 32), are positioned on the same side with respect to the tubular portion, (the light sources of the transceivers are both located in the arm 344 therefore in the same side, [0045]).
Regarding claim 22, Barrett in the combination outlined above teaches the apparatus of claim 10.
Barrett further teaches further comprising a system (Fig. 5 element 150) for monitoring the transceiver assemblies (Fig. 5 element 34), [0047], the monitoring system comprises a controller configured to synchronize the light sources (as shown in Fig. 10, [0073, 0077]) and/or means for modifying the power emitted by the light sources.
Regarding claim 23, Barrett in the combination outlined above teaches the apparatus of claim 10.
Barrett further teaches wherein the transceiver assemblies (Fig. 5 element 34) are assembled on a single support having a groove, (as shown in Fig. 5 and 6 element 34 is a single housing that comprise the arms 344 + 346 + “bridge” 348 generating a channel/groove where the tubular structure 32 is received as shown in Fig. 6, [0045, 0048]) intended to receive the tubular portion, Additionally the term " intended to receive the tubular portion " in the claim merely designates an intended use which does not carry enough weight so as to patentably distinguish from the cited prior See MPEP 2111.02).
Regarding claim 24, Barrett in the combination outlined above teaches the apparatus of claim 23.
Barrett further teaches a cover provided to at least partially cover the groove, (as shown in Fig 6 the housing of element 34 comprise a cover that as shown in Fig. 6 cover partially the groove, [0048]), said cover comprising a compression portion intended to hold in position the tubular portion positioned in the groove, (“The inner housing frame 162 also includes a spring that spans both arms 144, 146 and the bridge 102 (the spring is not shown). The spring biases the distal ends of the emitter arm 144 and the detector arm 146 towards one another so that they clip securely over the blood chamber 32”, [0048]).
Regarding claim 25, Barrett in the combination outlined above teaches the apparatus of claim 10.
Barrett further teaches wherein the light sources (Fig. 5 element 148) and all elements (Fig. 5 element 150) of the transceiver assemblies (Fig. 5 element 34) provided to be on the side of the corresponding light source (Fig. 5 element 148) with respect to the tubular portion (Fig. 4 element 32) are assembled on an upstream support, (as shown in Fig. 5 elements 150 + 148 in the emitter arm 144, [0048]) and the light sensors (Fig. 5 element 152) and all elements (Fig. 5 element 154 + 156) of the transceiver assemblies (Fig. 5 element 34) provided to be on the side of the corresponding light sensor with respect to the tubular portion (Fig. 4 element 32) are assembled on a downstream support (as shown in Fig. 5 elements 154 + 156 + 152 in the arm 146, [0048]) distinct from the upstream support, the downstream and upstream supports having complementary shapes (Fig. 6 element 102) provided to be coupled so as to enclose the tubular portion, (as shown in Fig. 6, [0048]).
Regarding claim 30, Barret teaches a method for determining the hematocrit level and/or the hemoglobin level of a fluid circulating in a tubular portion [0041-0042], Additionally, the term " for determining … tubular portion" in the preamble merely designates an intended use which does not carry enough weight so as to patentably distinguish from the cited prior art See MPEP 2111.02), comprising:
emitting light toward the tubular portion (Fig. 1 element 32) using at least one light source, (a LED emitter arm 344 that contains at least two LEDs and a photodetector arm 346 that contains at least two photodetectors that emit light toward a “tubular portion of element 32, as shown in Fig. 2 [0045],
receiving the light transmitted through the tubular portion (32) using a least one light sensor (a photodetector arm 346 that contains at least two photodetectors that received transmitted through the “tubular portion of element 32”, as shown in Fig. 2 [0045];
calculating at least one of a hematocrit level or a hemoglobin level of the fluid based on the received light, ( as shown in Fig. 5 element 34 comprise element 150 that calculates the hematocrit, oxygen saturation, and change in blood volume associated with blood passing through the blood chamber 32 to which the sensor clip assembly 34 is attached based on the raw data and calibration parameters, using a ratio metric model, [0049, 0056).
Even though Barrett teaches a monitoring system comprising a controller (Fig. 8 element 150 + 182) that control the power emitted by the light sources, [0064]. Barret is silent about modifying an emission power of the at least one light source during the determination of the hematocrit level and/or the hemoglobin level, wherein the emission power is controlled as a function of the calculated hematocrit level and/or hemoglobin level and is maintained at or below a maximum emission power of the light source.
Heinemann related to optical measurement system and thus from the same field of endeavor teaches modifying an emission power of the at least one light source during the determination of the hematocrit level and/or the hemoglobin level (the monitoring system comprising a controller Fig. 1 element 35, [col. 5, lines 28-31] configured to modify the emission power of the light sources Fig. 1 elements 27 + 29, during the determination of hematocrit level. The device comprise a feedback loop that provide a feedback of the intensity of the first and second light sources and hematocrit that is used to adjust the intensity of the light sources based on the feedback [Col. 2, lines 3-18] and [Col. 3, lines 6-22]),
wherein the emission power is controlled as a function of the calculated hematocrit level and/or hemoglobin level and is maintained at or below a maximum emission power of the light source., (“The feedback loop is responsive to the intensity of the light received by the signal detector to provide a feedback signal for adjusting the intensity of the light source so that the intensity of the light received by the signal detector is substantially constant over a range of values of the blood parameter. Means responsive to the feedback signal provides an output signal which provides an indication of the hematocrit. The feedback loop provides for accurate control of the light source.”, [Col. 2, lines 3-18], Therefore emission power is controlled as a function of the calculated hematocrit level). Even though Heinemann do not clearly disclose a maximum emission power of the light source, Heinemann discloses adjusting the intensity of the light source so that the intensity is maintained constant. Therefore, a person having ordinary skill in the art before the effective filing date of the claimed invention would reasonably arrive at the conclusion that, since the device is able to adjust the intensity of the light source it would be obvious to adjust the emission power at most equal of the maximum emission power of said light sources to prevent the light source to receive power over the maximum since it would affect the performance of the device as result of routine optimization in order to increase the durability of the device, thus allowing to increase efficiency of the measurement process, (see MPEP 2144.05).
Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Barrett by including modifying an emission power of the at least one light source during the determination of the hematocrit level and/or the hemoglobin level, wherein the emission power is controlled as a function of the calculated hematocrit level and/or hemoglobin level and is maintained at or below a maximum emission power of the light source (as taught by Heinemann) for several advantages such as: the first and second light sources are controlled directly by the light intensity at the signal detector, and this provides greater control over the light sources and improved accuracy of the device, [Col, 2, lines 57-60], Heinemann).
Regarding claim 31, Barret teaches an apparatus (Fig. 1) for determining the hematocrit level and/or the hemoglobin level of a fluid circulating in a tubular portion, [0041-0042], Additionally, the term " for determining … tubular portion" in the preamble merely designates an intended use which does not carry enough weight so as to patentably distinguish from the cited prior art See MPEP 2111.02),, comprising:
at least one light source arranged to emit light toward the tubular portion (a LED emitter arm 344 that contains at least two LEDs and a photodetector arm 346 that contains at least two photodetectors that emit light toward a “tubular portion of element 32, as shown in Fig. 2 [0045]);
at least one light sensor arranged to receive light transmitted through the tubular portion (a photodetector arm 346 that contains at least two photodetectors that received transmitted through the “tubular portion of element 32”, as shown in Fig. 2 [0045];;
at least one processor (Fig. 5 element 150) configured to calculate at least one of a hematocrit level or a hemoglobin level of the fluid based on the received light, ( as shown in Fig. 5 element 34 comprise element 150 that calculates the hematocrit, oxygen saturation, and change in blood volume associated with blood passing through the blood chamber 32 to which the sensor clip assembly 34 is attached based on the raw data and calibration parameters, using a ratio metric model, [0049, 0056); and
a controller (Fig. 8 element 150 + 182)
Even though Barrett teaches a controller (Fig. 8 element 150 + 182) that control the power emitted by the light sources, [0064]. Barret is silent about configured to modify an emission power of the at least one light source during determination of the hematocrit level and/or the hemoglobin level, wherein the emission power is controlled as a function of the calculated hematocrit level and/or hemoglobin level and is limited to at most a maximum emission power of the light source.
Heinemann related to optical measurement system and thus from the same field of endeavor teaches modifying an emission power of the at least one light source during the determination of the hematocrit level and/or the hemoglobin level (the monitoring system comprising a controller Fig. 1 element 35, [col. 5, lines 28-31] configured to modify the emission power of the light sources Fig. 1 elements 27 + 29, during the determination of hematocrit level. The device comprise a feedback loop that provide a feedback of the intensity of the first and second light sources and hematocrit that is used to adjust the intensity of the light sources based on the feedback [Col. 2, lines 3-18] and [Col. 3, lines 6-22]),
wherein the emission power is controlled as a function of the calculated hematocrit level and/or hemoglobin level and is maintained at or below a maximum emission power of the light source., (“The feedback loop is responsive to the intensity of the light received by the signal detector to provide a feedback signal for adjusting the intensity of the light source so that the intensity of the light received by the signal detector is substantially constant over a range of values of the blood parameter. Means responsive to the feedback signal provides an output signal which provides an indication of the hematocrit. The feedback loop provides for accurate control of the light source.”, [Col. 2, lines 3-18], Therefore emission power is controlled as a function of the calculated hematocrit level). Even though Heinemann do not clearly disclose limited to at most a maximum emission power of the light source., Heinemann discloses adjusting the intensity of the light source so that the intensity is maintained constant. Therefore, a person having ordinary skill in the art before the effective filing date of the claimed invention would reasonably arrive at the conclusion that, since the device is able to adjust the intensity of the light source it would be obvious to adjust the emission power to be limited the maximum emission power of said light sources to prevent the light source to receive power over the maximum since it would affect the performance of the device as result of routine optimization in order to increase the durability of the device, thus allowing to increase efficiency of the measurement process, (see MPEP 2144.05).
Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Barrett by including modifying an emission power of the at least one light source during the determination of the hematocrit level and/or the hemoglobin level, wherein the emission power is controlled as a function of the calculated hematocrit level and/or hemoglobin level and is limited to at most a maximum emission power of the light source. (as taught by Heinemann) for several advantages such as: the first and second light sources are controlled directly by the light intensity at the signal detector, and this provides greater control over the light sources and improved accuracy of the device, [Col, 2, lines 57-60], Heinemann).
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Barrett in view of Heinemann and further in view of Masumura et al. (US 2016/0338592 A1), hereafter Masumura.
Regarding claim 14, Barrett in the combination outlined above teaches the apparatus of claim 10.
Barrett further teaches an upstream lens(es) assembly (Fig. 2 elements 305 + 306) and being positioned between the corresponding light source and light sensor, (as shown in Fig. 6 the lens 305 that is part of element 32 is located between the LED 148 and the detector 152. Fig. 2 shows the lens 305 + 306 in details, [0044, 0048]), on the side of the light source with respect to the tubular portion ( the lens 305 + 306 are on both sides of the tubular portion of element 32, therefore upstream lens is located on the side of light source as shown in Fig. 4, [0045]).
Even though Barrett teaches the upstream lens assembly (Fig. 2 element 305 + 306), Barret does not explicitly state about collimation system comprises an upstream lens(es) assembly having a focal plane, the light source being positioned at more or less 10 mm from the focal plane of the upstream lens(es) assembly.
However, Barrett teaches “for accuracy of the system, it is important that the LEDs and the photodetectors be located in a predetermined position and orientation each time the sensor clip assembly is clipped into place over the blood chamber. The predetermined position and orientation ensures that light traveling from the LEDs to the photodetectors travels through the lenses of the blood chamber.” [0009]. Therefore, a person having ordinary skill in the art before the effective filing date of the claimed invention would reasonably arrive at the conclusion that the predetermined position of the LEDs is at more or less 10 mm from the focal plane of the lens as a result of maintain the accuracy of the system, [0009]. Moreover, the particular placement of parts has been held to be an obvious matter of design choice (see MPEP 2144.04 Section VI-C).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the light source position (as taught by Barrett) with a specific distance of at more or less 10 mm from the focal plane of the lens as result of routine optimization in order to create a beam of light that maintains a consistent diameter over a distance, with the image of the source effectively projected to infinity thus decrease energy loss and maintains energy concentration (see MPEP 2144.05).
The modified device of Barrett still lack to teach collimation system comprises an upstream lens(es) assembly having a focal plane.
However Masumura related to optical measurement system and thus from the same field of endeavor teaches collimation system (Fig. 3 elements 220 + 330) comprises an upstream lens(es) assembly (Fig. 3 element 330) having a focal plane, (elements 220 + 230 collimate the light generated from the light source, [0026]. Additionally, the light rays leave the point on the focal plane (210 + 220), to be able to emerge from the lens as a parallel, collimated beam as shown in Fig. 2 element 110).
Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Barrett by including collimation system comprises an upstream lens(es) assembly having a focal plane, (as taught by Masumura) for several advantages such as: the light irradiated onto the test object is adjusted allowing to satisfy the safety standard thus increase the efficiency of the device, ([0026], Masumura). Additionally, the collimation system allows to perform stable and repeatable measurements since the light entering a sample must arrive at a specific angle with high consistency and a correctly positioned focal plane ensures a consistently collimated beam.
Regarding claim 15, Barrett in the combination outlined above teaches the apparatus of claim 10.
Barret further teaches wherein downstream lens(es) assembly (Fig. 2 elements 305 + 306) being positioned between the corresponding light source and light sensor (as shown in Fig. 6 the lens 305 that is part of element 32 is located between the LED 148 and the detector 152. Fig. 2 shows the lens 305 + 306 in details, [0044, 0048]), on the side of the light sensor with respect to the tubular portion (the combination of lens 305 + 306 are on both sides of the tubular portion of element 32, therefore downstream lens is located on the side of light sensor as shown in Fig. 4, [0045]).
Even though Barrett teaches the downstream lens assembly (Fig. 2 element 305 + 306), Barret does not explicitly state about collimation system comprises a lens(es) assembly having a focal plane, the light source being positioned at more or less 10 mm from the focal plane of the downstream lens(es) assembly.
However, Barrett teaches “for accuracy of the system, it is important that the LEDs and the photodetectors be located in a predetermined position and orientation each time the sensor clip assembly is clipped into place over the blood chamber. The predetermined position and orientation ensures that light traveling from the LEDs to the photodetectors travels through the lenses of the blood chamber.” [0009]. Therefore, a person having ordinary skill in the art before the effective filing date of the claimed invention would reasonably arrive at the conclusion that the predetermined position of the LEDs is at more or less 10 mm from the focal plane of the lens as a result of maintain the accuracy of the system, [0009]. Moreover, the particular placement of parts has been held to be an obvious matter of design choice (see MPEP 2144.04 Section VI-C).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the light source position (as taught by Barrett) with a specific distance of at more or less 10 mm from the focal plane of the lens as result of routine optimization in order to create a beam of light that maintains a consistent diameter over a distance, with the image of the source effectively projected to infinity thus decrease energy loss and maintains energy concentration (see MPEP 2144.05).
The modified device of Barrett still lack to teach collimation system comprises an lens(es) assembly having a focal plane.
However Masumura further teaches a collimation system (Fig. 3 elements 220 + 330) comprises a lens(es) assembly (Fig. 3 element 330) having a focal plane, (elements 220 + 230 collimate the light generated from the light source, [0026]. Additionally, the light rays leave the point on the focal plane (210 + 220), to be able to emerge from the lens as a parallel, collimated beam as shown in Fig. 2 element 110).
Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Barrett by including collimation system comprises an lens(es) assembly having a focal plane, (as taught by Masumura) for several advantages such as: the light irradiated onto the test object is adjusted allowing to satisfy the safety standard thus increase the efficiency of the device, ([0026], Masumura). Additionally, the collimation system allows to perform stable and repeatable measurements since the light entering a sample must arrive at a specific angle with high consistency and a correctly positioned focal plane ensures a consistently collimated beam.
Regarding claim 16, Barrett in the combination outlined above teaches the apparatus of claim 10.
Barrett further teaches wherein a downstream lens(es) assembly (Fig. 2 elements 305 + 306) being positioned between the corresponding light source and light sensor (as shown in Fig. 6 the lens 305 that is part of element 32 is located between the LED 148 and the detector 152. Fig. 2 shows the lens 305 + 306 in details, [0044, 0048]), on the side of the light sensor with respect to the tubular portion (the combination of lens 305 + 306 are on both sides of the tubular portion of element 32, therefore downstream lens is located on the side of light sensor as shown in Fig. 4, [0045]).
Even though Barrett teaches the downstream lens assembly (Fig. 2 element 305 + 306), Barret does not explicitly state about collimation system comprises a lens(es) assembly having a focal plane, the downstream lens(es) assembly is positioned so that the light beams leaving the outlet wall of the tubular portion converge at more or less 10 mm from the focal plane of the downstream lens(es) assembly.
However, Masumura further teaches a collimation system (Fig. 3 elements 220 + 330 + 330 + 510) comprises downstream lens(es) assembly (Fig. 3 element 510) having a focal plane, [0026], , the downstream lens(es) assembly (510) is positioned so that the light beams leaving an outlet wall (Fig. 3 element 400) of the tubular portion converge at more or less 10 mm from the focal plane of the downstream lens(es) assembly, (as shown in Fig. 3 light beam leaving element 400 interact with element 510 to fucus the light beam to converge in the focal plane of the lens 510 as shown in Fig. 3 as it form an image on the sensor 520 that is where the light converge, [0028, 0051]). Additionally, a prima facie case of obviousness exists where the claimed ranges and the prior art ranges do not overlap but are close enough that one skill in the art would have expected them to have the same properties (Titanium Metals Corporation of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985); See MPEP 2144.05). Also, it is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions (see MPEP 2144.05 Section II-A).
Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Barrett by including a collimation system comprises downstream lens(es) assembly having a focal plane, the downstream lens(es) assembly is positioned so that the light beams leaving the outlet wall of the tubular portion converge at more or less 10 mm from the focal plane of the downstream lens(es) assembly, (as taught by Masumura) for several advantages such as: the light irradiated onto the test object is adjusted allowing to satisfy the safety standard thus increase the efficiency of the device, ([0026], Masumura). Additionally, the collimation system allows to perform stable and repeatable measurements since the light entering a sample must arrive at a specific angle with high consistency and a correctly positioned focal plane ensures a consistently collimated beam.
Regarding claim 17, Barrett in the combination outlined above teaches the apparatus of claim 10.
The modified device of Barrett fail to teach wherein collimation system comprises an upstream diaphragm positioned between the corresponding light source and light sensor on the side of the light source with respect to the tubular portion, the upstream diaphragm being provided to let pass a central portion of the light beams emitted by the light source in the direction of the light sensor and to stop a peripheral portion of the light beams emitted by the light source.
However, Masumura further teaches wherein collimation system (Fig. 3 elements 220 + 230 + 240 + 250 + 330 + 510) comprises an upstream diaphragm (Fig. 3 elements 220 + 240 + 250) positioned between the corresponding light source (Fig. 3 element 210) and light sensor (Fig. 3 element 520) on the side of the light source with respect to the tubular portion (Fig. 3 element 400), (as shown in Fig. 3, [0026]), the upstream diaphragm (220 + 240) being provided to let pass a central portion of the light beams emitted by the light source in the direction of the light sensor and to stop a peripheral portion of the light beams emitted by the light source, ( as shown in Fig. 3 the beam size and the light intensity are properly adjusted by a variable aperture diaphragm 240 and an ND filter 250, [0026]).
Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Barrett by including wherein at least one, and preferably each, collimation system comprises an upstream diaphragm positioned between the corresponding light source and light sensor on the side of the light source with respect to the tubular portion, the upstream diaphragm being provided to let pass a central portion of the light beams emitted by the light source in the direction of the light sensor and to stop a peripheral portion of the light beams emitted by the light source, (as taught by Masumura) for several advantages such as: the light irradiated onto the test object is adjusted allowing to satisfy the safety standard thus increase the efficiency of the device, also the device lets to adjust the intensity and beam side of the light beam thus allows to illuminate the effective region of a spatial light modular, ([0026], Masumura).
Claims 18 are rejected under 35 U.S.C. 103 as being unpatentable over Barrett in view of Heinemann and further in view of Obata et al. (US 2019/0017915 A1), hereafter Obata.
Regarding claim 18, Barrett in the combination outlined above teaches the apparatus of claim 10.
The modified device of Barrett fail to teach wherein collimation system comprises a downstream diaphragm positioned between the corresponding light source and light sensor on the side of the light sensor with respect to the tubular portion, the downstream diaphragm being provided to let pass a central portion of the light beams transmitted through the tubular portion in the direction of the light sensor and to stop a peripheral portion of the light beams transmitted through the tubular portion.
However, Obata related to optical measurement devices and thus from the same field pf endeavor teaches wherein at least one, and collimation system (Figs. 5 and 14, elements, diaphragm “no show” + 132 + 133+ + 144 + 145 + 146 + 147) comprises a downstream diaphragm ( Fig. 14 element diagram + 147) positioned between the corresponding light source (Fig. 14 element 131) and light sensor (Fig. 14 element 140) on the side of the light sensor with respect to the tubular portion, (the diaphragm is located in the area ST on the side of the light sensor 140 respect to the sample 100, 117, 181]), the downstream diaphragm being provided to let pass a central portion of the light beams transmitted through the tubular portion (Fig. 5 element 100) in the direction of the light sensor and to stop a peripheral portion of the light beams transmitted through the tubular portion, (the diaphragm member being arranged in the middle of the detection light path ST toward the backscattered light detector, [0117]).
Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Barrett by including wherein at least one, and preferably each, collimation system comprises a downstream diaphragm positioned between the corresponding light source and light sensor on the side of the light sensor with respect to the tubular portion, the downstream diaphragm being provided to let pass a central portion of the light beams transmitted through the tubular portion in the direction of the light sensor and to stop a peripheral portion of the light beams transmitted through the tubular portion, (as taught by Obata) for several advantages such as: the light having passed through the diaphragm member is converged with the detection surface of the light detector being a conjugate focus position, thus allow to measure the irradiation from the vicinity of the inner wall of the sample cell as it passes through the diaphragm member, but the other scattered light does not pass, through the diaphragm member, with the result that only the scattered light from the particles is detected under a state of being focused on the light detector, thus increasing the accuracy of the device ([0118], Obata).
Claims 19 is rejected under 35 U.S.C. 103 as being unpatentable over Barrett in view of Heinemann and further in view of HIGGINS et al. (WO 2007033318 A2), hereafter HIGGINS.
Regarding claim 19, Barrett in the combination outlined above teaches the apparatus of claim 10.
Even though that Barret teaches a transceiver (Fig. 1 element 34) that comprise a light source (Fig. 3 element 344) and the light sensor (Fig. 3 element 346), the modified device of Barrett fail to teach wherein at least one, and collimation system comprises an upstream filter positioned between the corresponding light source and light sensor on the side of the light source with respect to the tubular portion and/or a downstream filter positioned between the corresponding light source and light sensor on the side of the light sensor with respect to the tubular portion, the upstream and downstream filters of the collimation system of a transceiver assembly being provided to filter at least the emission wavelength of the light source of the other transceiver assembly
However, Higgins related to optical measuring devices and thus form the same field of endeavor teaches wherein at least one collimation system (Fig. 2B element 21) comprises an upstream filter (element 21 is a wavelength filter, [0054]) positioned between the corresponding light source (Fig. 2B element 18) and light sensor (Fig. 2b element 22) on the side of the light source with respect to the tubular portion (Fig. 2B element 26), (as shown in Fig. 2B, [0054]), and/or a downstream filter positioned between the corresponding light source and light sensor on the side of the light sensor with respect to the tubular portion, the upstream and downstream filters of the collimation system of a transceiver assembly (Fig. 2B element 18 + 22) being provided to filter at least the emission wavelength of the light source of the other transceiver assembly, (a single or multiple light sources 18 may be transmitted through a wavelength filter 21, such as a filter wheel, to provide an alternate or additional embodiment of discrete wavelengths that may be time multiplexed, [0054]).
Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Barrett by including wherein at least one, and preferably each collimation system comprises an upstream filter positioned between the corresponding light source and light sensor on the side of the light source with respect to the tubular portion and/or a downstream filter positioned between the corresponding light source and light sensor on the side of the light sensor with respect to the tubular portion, the upstream and downstream filters of the collimation system of a transceiver assembly being provided to filter at least the emission wavelength of the light source of the other transceiver assembly, (as taught by Higgins) for several advantages such as: a filter wheel lets provide discrete wavelengths that may be time multiplexed allowing to effectively map the wavelength information to the time domain thus increase the accuracy of the device, ([0054], Higgins).
Claims 4 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Barrett in view of Heinemann and further in view of Mori et al. (US 2004/0067594 A1), hereafter Mori.
Regarding claim 4, Barrett in the combination outlined above teaches the apparatus of claim 1.
Even though the modified device of Barrett teaches wherein the emission power of at least one of the light sources is adjust, [Col. 3, lines 6-16], Heinemann), The modified device of Barret is silent about wherein the emission power of at least one of the light sources is increased from a threshold value of the hematocrit level and/or the hemoglobin level calculated for the fluid.
However, Mori related to optical measurement system and thus from the same field of endeavor teaches adjusting the slit width to give a proportional relationship between the hematocrit value (%) and the output voltage of element 14, [0110]. Even though Mori do not explicitly disclose wherein the emission power of at least one of the light sources is increased from a threshold value of the hematocrit level and/or the hemoglobin level calculated for the fluid. A person of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that the device perform a known function of adjusting the emission power of light beams based on the hematocrit value and is predictable to apply the same function to increase the power from a threshold value of the hematocrit level in order to maintain a proportional relationship.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the emission power of the light source (as taught by the Mori) from a threshold value of the hematocrit level without deviating from the general teaching concept of the modified device of Barret as result of routine optimization in order to give a proportional relationship between the hematocrit value (%) and the output voltage thus increase the accuracy of the device.
Regarding claim 26, Barrett in the combination outlined above teaches the apparatus of claim 10.
Even though Barret teaches determination of the hematocrit level and/or the hemoglobin level, [0045]. The modified device of Barrett is silent about a determination of the hematocrit level and/or the hemoglobin level without deformation of the tubular portion.
However, Mori related to optical measurement system and thus from the same field of endeavor teaches a determination of the hematocrit level and/or the hemoglobin level without deformation of the tubular portion, [0046, 0077].
Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Barrett by including a determination of the hematocrit level and/or the hemoglobin level without deformation of the tubular portion, (as taught by Mori) for several advantages such as: the sensor can prevent deformation of the flexible tube comprising the blood circuit and allows the overall size of the sensor to be reduced, ([0077], Mori).
Claim 27-29 is rejected under 35 U.S.C. 103 as being unpatentable over Barrett in view of Heinemann and further in view of Dam et al. (US 2012/0203476 A1), hereafter Dam.
Regarding claims 27-29, Barrett in the combination outlined above teaches the apparatus.
Barrett further teaches: (claim 28) wherein the light sources and all elements of the transceiver assemblies (Fig. 4 element 34) provided to be on the side of the corresponding light source (Fig. 4 element 344) with respect to the tubular portion (Fig. 4 element 32) are positioned on one side, (as shown in Fig. 4, [0045]) of a major axis defining the ellipsoidal section, and the light sensors and all elements of the transceiver assemblies (Fig. 4 element 34) provided to be on the side of the corresponding light sensor (Fig. 4 element 346) with respect to the tubular portion (Fig. 4 element 32) are positioned on the other side, (as shown in Fig. 4, [0045]) of the major axis defining the ellipsoidal section.
Even though Barret teaches the transceiver assemblies, (Fig. 3 element 34), Barret is silent about:
(claim 27) a system for deforming the tubular portion facing the measuring assemblies, the deformation system being provided to deform a circular section of the tubular portion into an ellipsoidal section.
(claim 28) the light source with respect to the tubular portion are positioned on one side, of a major axis defining the ellipsoidal section, light sensor with respect to the tubular portion are positioned on the other side of the major axis defining the ellipsoidal section.
(claim 29) wherein the ellipsoidal section is defined by a major radius the major axis along and by a minor radius (Rb) along a minor axis perpendicular to the major axis, the ellipsoidal section having, in a deformed state of the tubular portion, a small minor radius (Rb) having a length comprised between 30% and 70% of the radius of the circular section of the tubular portion in an undeformed state.
However Dam related to optical measuring system and thus from the same field of endeavor teaches:
(claim 27) a system (measuring head) for deforming the tubular portion (Fig. 1 element 126 + 128) facing the measuring assemblies, [0023-0024], the deformation system being provided to deform a circular section of the tubular portion into an ellipsoidal section, (as shown in Fig. 2, [0023-0024]).
(claim 28) the light source (Fig. 3 element 66) with respect to the tubular portion are positioned on one side of a major axis defining the ellipsoidal section, the light sensor (Fig. 3 element 68) with respect to the tubular portion are positioned on the other side of the major axis defining the ellipsoidal section, (as shown in Fig. 3 elements 66 and 68 are in opposite sides of the major axis of the ellipsoidal section 12A + 126B, [0023, 0065]). Additionally, it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Moreover, the particular placement of parts has been held to be an obvious matter of design choice (see MPEP 2144.04 Section VI-C).
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(claim 29) wherein the ellipsoidal section is defined by a major radius the major axis (as indicated in the annotated Fig. 2 above by the broken line) along and by a minor radius (Rb) along a minor axis (as indicated in the annotated Fig. 2 above by the broken line)perpendicular to the major axis, (as shown in annotated Fig. 2), the ellipsoidal section having, in a deformed state of the tubular portion, [0023-0024], a small minor radius (Rb) having a length comprised between 30% and 70% of the radius of the circular section of the tubular portion in an undeformed state, (“the tubing typically is squeezed by an amount of from about 10% to 30% of its original outer cross-sectional length although it could be less or more”, Therefore the minor axis is a 70% of the undeform state, [0023]. Additionally, It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions (see MPEP 2144.05 Section II-A).
Therefore, it would been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Barrett by including a system for deforming the tubular portion facing the measuring assemblies, the deformation system being provided to deform a circular section of the tubular portion into an ellipsoidal section, the light source with respect to the tubular portion are positioned on one side, of a major axis defining the ellipsoidal section, light sensor with respect to the tubular portion are positioned on the other side of the major axis defining the ellipsoidal section, wherein the ellipsoidal section is defined by a major radius the major axis along and by a minor radius (Rb) along a minor axis perpendicular to the major axis, the ellipsoidal section having, in a deformed state of the tubular portion, a small minor radius (Rb) having a length comprised between 30% and 70% of the radius of the circular section of the tubular portion in an undeformed state (as taught by Dan) for several advantages such as: since the tubing in the slot can be deformed it allow it to be squeezed, thus effectively bonds to the face of the wall whose material serves as a coupling medium to convey ultrasonic energy to and from the sensor, ([0027], Dan).
Allowable Subject Matter
Claims 5-7 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.
Regarding Claim 5, the prior art of record, taken either alone or in combination, fails to disclose, teach, or suggest or render obvious “the emission power of the light source is set to a value comprised between 10% and 30% of the maximum emission power of said light source when the calculated hematocrit level is lower than 30%; and- the emission power of the light source is set to a value comprised between 30% and 60% of the maximum emission power of said light source when the calculated hematocrit level is higher than or equal to 30%.”, in the combination required by the claim.
Regarding Claim 6, the prior art of record, taken either alone or in combination, fails to disclose, teach, or suggest or render obvious “wherein the emission power of at least one of the light sources is adjusted so that: - the emission power of said light source is at a first power level for values of the hematocrit level calculated for the fluid lower than a first threshold value; - the emission power of said light source is at a second power level for values of the hematocrit level calculated for the fluid higher than or equal to the first threshold value but lower than a second threshold value higher than the first threshold value; and - the emission power of said light source is at a third power level for values of the hematocrit level calculated for the fluid higher than or equal to the second threshold value.”, in the combination required by the claim.
Regarding Claim 7 are directly/indirectly dependent on claim 6 and are allowable based on their dependencies.
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.
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/CARLOS PEREZ-GUZMAN/ Examiner, Art Unit 2877
/Kara E. Geisel/ Supervisory Patent Examiner, Art Unit 2877
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