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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 18, 2024 and June 15, 2026 are being considered by the examiner.
Claim Objections
Claims 1, 7 and 11 are objected to because of the following informalities:
In claim 1, the limitation “fot” is misspelled.
In claim 7, the limitation “frum” is misspelled.
In claim 11, the recitation “directing…directed” is redundant. The limitation “directed” should be deleted.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
In the event the determination of the status of the application as subject to AIA (or as subject to pre-AIA ) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the rationale supporting the rejection would be the same under either status.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 4 and 7 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 4 recites “the hemoglobin presence”. There is no antecedent basis for the limitation.
Claim 7 recites “the layers”. There is no antecedent basis for the limitation.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Guiney et al. (“Guiney”) (US 2008/0144005 A1) in view of Adamczyk et al. (“Adamczyk”) (US 2010/0178660 A1).
With respect to claim 1, Guiney discloses an opacity testing device for a liquid sample, the device comprising (see Fig. 5):
a vessel 10 adapted for storing a liquid 12 having an opacity, the vessel being transparent (see Fig. 5 illustrating light 512 passing through the vessel);
an illumination source 510 directed at a side of the vessel 10;
a photometer 520 disposed on a side of the vessel 10 opposite the illumination source 510; and
a processor 530 connected to the photometer, the processor having nucleation logic for receiving an illuminance from the photometer (see [0058]-[0059]), the illuminance indicative of cell lysis (see [0059]).
The device taught by Guiney differs from the claimed invention in that Guiney does not disclose that the processor 530 computes a measure of healthy cells in the vessel based on the illuminance. While the processor 530 determines the extent of hemolysis in the liquid (see [0059]), which corresponds to the amount of hemoglobin in the sample (see abstract), it does not use this information to compute a measure of healthy cells in the sample.
Adamczyk discloses a method of quantifying hemoglobin in a stored blood sample for the purpose of determining whether the sample has exceeded its shelf-life (see abstract, [0007] and [0291]), wherein correlation exists between age/degradation of the blood sample and the amount of hemoglobin in the plasma (see [0007] and [0291]). In light of the disclosure of Adamczyk, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the processor taught by Guiney to use its information to determine a measure of healthy cells in a sample of blood (i.e. determine whether the sample has degraded to the point it has exceeded its shelf life).
With respect to claim 2, the sample is not a part of the claimed invention. Consequently, the combination of Guiney and Adamczyk need not teach limitations directed to the sample to reject a claim. In this instance, based on the volume of the sample, the claimed “sensed layer” can be situated at any height within the vessel, including the height at which the illumination source 510 and the photometer 520 are situated in Fig. 5 of Guiney.
With respect to claim 3, the vessel 10 is adapted to contain a sample of blood, in which case the opacity would be based on hemoglobin present in the plasma.
With respect to claim 4, the illumination source has a wavelength based on passage through the sample responsive to hemoglobin presence in the sample (see abstract of Guiney).
With respect to claims 5-7, as discussed above, the sample is not a part of the claimed invention. Consequently, the combination of Guiney and Adamczyk need not teach limitations directed to the sample to reject the claim.
With respect to claim 8, the processor is part of a computer (see [0058]), meaning it further comprises a memory, the memory coupled to the processor. Moreover, given that the absorbance values correlate directly to the concentration of hemoglobin in the sample, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the processor to calculate the hemoglobin concentration in the plasma of the sample such that the measurement can be compared to a healthy blood sample (see [0007] of Adamczyk disclosing concentration of hemoglobin in the plasma of a normal blood sample). Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the processor to make the calculation using any conventional mathematical algorithm, for example by using a table of values that maps absorbance values to hemoglobin concentrations (e.g. a standard curve).
With respect to claim 11, as discussed above (see rejection of claim 1), the combination of Guiney and Adamczyk discloses a device for testing the health and longevity of a stored red blood sample. Naturally, a method of using the device would comprise the following steps:
storing a blood sample having an opacity (colored plasma) in the transparent vessel 10;
directing the illumination source 510 at a side of the transparent vessel 10;
receiving illuminance at the photometer 520, the illuminance indicative of cell lysis; and
computing a measure of healthy cells in the vessel based on the illuminance.
With respect to claim 12, as discussed above, the method would apply to a stored blood sample. Given that blood fractionates naturally during storage, and given that Adamczyk discloses that the plasma is the component of blood that is of interest (see [0007]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the method on a stored blood sample that has fractionated into various layers, and aligned the illumination source and the photometer with the plasma layer of the fractionated blood sample.
With respect to claim 13, as discussed above, the illuminance results from opacity of the plasma caused by hemoglobin in the plasma.
With respect to claim 14, as discussed above, the illumination source 510 has a wavelength based on passage through the plasma layer responsive to the presence of hemoglobin in the plasma (see also abstract of Guiney).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Guiney in view of Adamczyk as applied to claims 1-8 and 11-14 above, and further in view of Hansen (US 6,980,285 B1) and Fukamizu et al. (Fukamizu) (US 2009/0079984 A1).
The combination of Guiney and Adamczyk does not disclose a temperature sensor or an accelerometer.
Regarding the temperature sensor, Hansen discloses that optical analysis of blood is temperature-sensitive (see lines 34-39, col. 19) and proposes a spectrophotometer comprising a temperature sensor for maintaining the temperature of the sample at a specified temperature during analysis (see lines 55-59, col. 10 and lines 46-58, col. 18). In light of the disclosure of Hansen, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the modified Guiney device with a temperature sensor and configured the memory of the device to record the temperature of samples during measurements.
Regarding the accelerometer, Fukamizu discloses a photometer for optically analyzing a specimen (see abstract). To obviate the effects of vibration and other movement that may affect the alignment of its light source and its light detector, the photometer comprises a shake detector 30 (see [0026] and Fig. 3). In light of the disclosure of Fukamizu, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the modified Guiney device with a conventional sensor (e.g. accelerometer) for detecting vibrations during measurement.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Guiney in view of Adamczyk as applied to claims 1-8 and 11-14 above, and further in view of JP S63156059 U (“JP”).
The combination of Guiney and Adamczyk does not disclose a height control.
JP discloses a spectrophotometer comprising a height control for adjusting the height of a sample vessel inside a measuring cell of the spectrophotometer such that samples comprising minute volumes can be aligned with a light source by raising the sample vessel (see Fig. 2). In light of the disclosure of JP, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the modified Guiney device with a height control for aligning the sample with the illumination source 510 and the photometer 520. The modification would enable the modified Guiney device to analyze even minute volumes of sample.
Conclusion
The following prior art is considered pertinent to Applicant's disclosure:
Dubey et al. (US 2020/0200730 A1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796
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