DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species B: Figure 5A-5B in the reply filed on 5/11/2026 is acknowledged.
Applicant argues that Claims 1-4, 6-12, 14, and 20-23 are commensurate in scope with the elected species. However, the examiner notes that the following claims are drawn to non-elected species:
Claims 2,-4 and 6 (drawn to a gravimetric blood volume sensor, exemplified in Species A: Figure 3)
Claim 16 (drawn to a camera sensor, exemplified in Species F: Figure 11)
Claim 18 (drawn to a time-of-flight laser sensor, exemplified in Species G: Figure 12)
Claim 19 (drawn to an ultrasound time-of-flight sensor, exemplified in Species H: Figure 13).
Accordingly, Claims 2-4, 6, 16, and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102 / Claim Rejections - 35 USC § 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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, 20, 22, and 23 are rejected under 35 U.S.C. 102((a)(1) as anticipated by Wilson (US 2017/0326288) or, in the alternative, under 35 U.S.C. 103 as obvious over Wilson (US 2017/0326288) in view of Meisberger et al. (US 2016/0375185).
With respect to Claim 1, Wilson teaches a blood volume sensor system (see Abstract; Figures 1 and 4) comprising:
a container 120 defining a blood volume reservoir (paragraph [0025]; Figure 1);
a volume sensor 124 configured to sense the volume of blood in the reservoir (paragraph [0032]; sensor 124 is a level sensor that senses the level of blood within the reservoir, which is proportional to the volume of blood present [0030-0032]) and output data corresponding to a volume of blood contained in the blood volume reservoir [0033-0034]; and
a digital computing device (not pictured; the controller controls a pump and/or valve in response to the sensed blood level; see “control” in paragraphs [0032-0033]“; see “controller” in paragraphs [0051], [0054], [0058]; Figure 5) in communication with the volume sensor and configured to receive the output data regarding the volume of blood contained in the blood volume reservoir (paragraphs [0032-0033], [0051-0058]; note that paragraph [0051] states that the control algorithm of Figure 5 can be practiced with the system of Figure 1).
Specifically, Wilson’s sensor 124 is technically a level sensor that senses the height of blood within the reservoir. However, the examiner notes that Wilson further indicates a relationship between level and volume [0030-0034]. Therefore, Wilson’s level sensor 124 is configured to monitor the blood volume in the reservoir as claimed.
However, in the event that this interpretation is not clearly envisaged by applicant, Meisberger teaches a blood reservoir 11 comprising vertical sensing means (9, 10, 12, 13) for sensing the liquid level or volume within the reservoir (Figure 1, paragraph [0031]). Specifically, Meisberger explicitly teaches that the level of blood in the reservoir is indicative of the volume of blood in the reservoir [0031-0036]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Wilson’s blood volume reservoir and sensor system to monitor blood volume, because Meisberger teaches that blood level and blood volume are proportional and effectively constitute the same measurement in the context of a blood reservoir.
With respect to Claim 20, Wilson teaches that the system further comprises an oxygenator 140 attached to the blood volume reservoir 120 (Figure 1; paragraph [0025]).
With respect to Claim 22, Wilson teaches that the sensor 124 is incorporated into a surgical pack of a heart lung machine (i.e. it is included with the blood reservoir 120, pump 130, oxygenator 140, and arterial filter 150 to form a surgical pack of a heart lung machine). The examiner notes that no structure related to the “surgical pack” has been claimed.
With respect to Claim 23, Wilson teaches that the sensor 124 measures the level/volume of blood in the reservoir 124 in real time (the controller makes real-time adjustments to the speed of the pump and/or the status of the valve based on the sensed quantity of blood in the reservoir; paragraphs [0030-0035]).
Claims 7-11, 14, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Meisberger.
With respect to Claims 7-11, Wilson teaches the blood volume sensor system as claimed, wherein the level sensor is responsive to the level of blood in the reservoir [0032], but does not specifically teach that the volume sensor is an optical sensor, or more specifically a contact imaging sensor including an array of photodiodes configured to detect light emitted by a light source, wherein the light source and array of photodiodes are positioned along a height of the reservoir or along a top of the reservoir and is configured to shine light through the reservoir.
Meisberger teaches a blood reservoir 11 comprising vertical sensing means (9, 10, 12, 13) for sensing the level or volume of blood within the reservoir (Figure 1, paragraph [0031]). Specifically, the vertical sensing means (9, 10, 12, 13) comprise an optical sensor comprising a contact imaging sensor including an array of photodiodes 10 configured to detect light emitted by a light source 12 (Figure 1; paragraph [0032], wherein the light source 12 and photodiodes 10 are positioned along a height of the reservoir 11 such that the light source is configured to shine light through the transparent reservoir toward the photodiodes (Figures 1-2; paragraphs [0030-0036]). This system enables the level/volume of blood present in the reservoir to be determined, while allowing the system to easily and reliably discriminate between liquid blood and blood or lipid films on the inner surface of the vessel (see abstract and paragraphs [0002], [0008], [0011], and [0034]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Wilson’s blood volume sensor system to use a vertical light source and photodiode array on the side of the reservoir for sensing the level/volume of blood therein, as suggested by Meisberger, in order to provide a well-known, alternate level sensor configuration for sensing blood level within a blood reservoir, while providing accurate results that easily reliably discriminate between liquid blood and blood or lipid films on the inner surface of the vessel (see abstract and paragraphs [0002], [0008], [0011], and [0034]).
With respect to Claim 14, Meisberger’s light source and receiver (10, 12) is in communication with a microcontroller unit (electronic switches 9 and 13). Alternatively, the sensor (10, 12) and electrical switches (9, 13) are in communication with a microcontroller 2 that controls operation of the switches, light source, and light receivers (Figure 1; paragraphs [0035-0057]). When combined with Wilson as proposed above, the resulting system would have a microcontroller for controlling the sensor and a main controller for controlling the pump and valve.
In the event that applicant does not clearly envisage Meisberger as clearly suggesting a microcontroller that is separate from Wilson’s main controller, it has been held that the mere separation of integrated parts does not constitute a patentable improvement in the art when said separation does not result in a non-obvious change in functionality (see MPEP § 2144.04.V.C). In this case, it is unclear why providing a separate microcontroller controlling the optical sensor from the main controller controlling Wilson’s pump and valve would fundamentally alter the functionality of the device. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the blood volume sensor system of Wilson to have a separate microcontroller for controlling the optical sensor and main controller for controlling the pump and valve of the extracorporeal system, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art.
With respect to Claim 21, the combination of Wilson and Meisberger discussed above with respect to Claim 7 reasonably suggests a light source that is positioned along a height of the reservoir and configured to shine a light through the reservoir. Specifcally, the reservoir is transparent, thereby allowing the light source to pass through the reservoir (see paragraph [0030] of Meisberger).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson and Meisberger as applied to claim 9 above, and further in view of Satish (US 2013/0301901).
With respect to Claim 12, Wilson and Meisberger reasonably suggest a blood volume sensor system comprising an contact imaging sensor having a linear array of photodiodes as claimed (see the rejection above), but do not specifically suggest that the linear array of photodiodes includes a linear array of more than 5000 CMOS sensor pixels.
However, CMOS sensors are well known in the art of optical sensors. For example, Satish teaches a system and method of estimating quantity of blood in a fluid canister (title, abstract), wherein an optical sensor 110 is used to determine the blood level in the canister [0068]. Specifically, Satish teaches that the optical sensor may be any of a variety of types, including complementary metal-oxide-semiconductor (CMOS) active pixel sensors [0068]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the blood volume sensor system of Wilson and Meisberger to use a CMOS sensor as the linear array of photodiodes, as suggested by Satish, in order to provide a well-known, alternate means for determining the blood level/volume within the reservoir.
Furthermore, regarding the claimed pixel count of 5000 CMOS sensor pixels, Zuo is silent as to the pixel count of the sensor. However, it is the examiner’s position that a skilled artisan would have understood that increasing the density of the photodiodes/pixels will increase the resolution and precision of the resulting image. It would have been obvious to one of ordinary skill in the art prior to the effective filing date to provide the sensor with more than 5000 CMOS sensor pixels, or in any other resolution that was determined to be sufficiently precise, in order to increase the precision of the sensor, and because a skilled artisan would have recognized the predictable relationship between pixel count and resolution/precision.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson and Meisberger as applied to claim 9 above, and further in view of Zuo et al. (US 2022/0011563).
With respect to Claim 15, Wilson and Meisberger reasonably suggest the blood volume sensor system of claim 9 (see the rejection above), but do not specifically teach that the contact imaging sensor additionally includes at least one layer of neutral density filter film positioned on the contract imaging sensor.
However, the use of neutral density filter films is extraordinarily well known in the art of optics and imaging. For example, Zuo teaches an imaging method wherein a neutral density filter film is applied to a phase contrast plate to reduce halos and improve the contrast of the light being received [0028]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the blood volume
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Macintyre (US 11,022,619) teaches a blood reservoir having a volume sensor thereon.
Hashimoto (US 2019/0351128) teaches an extracorporeal system comprising a blood reservoir having a level sensor.
Knott (US 2019/0070353) teaches an extracorporeal system comprising a blood reservoir having a level sensor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/ Primary Examiner, Art Unit 3781
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