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 .
Claims 1-22 are pending in the application.
Claim Objections
The following claims are objected to.
Claims 6-7 introduce “CH” and “CV’, but do not specify what they refer to.
Claim 10 recites “R/G/B three-channel”, but claim 13, dependent upon claim 10, recites “any channel” (multiple occurrences). It is suggested claim 13 recites “any channel of the R/G/B channel”.
Claim 18 5th line recites “CHGBs represents the hemoglobin concentration of all target cells in the microscopically magnified digital image”. Examiner believes CHGBs represents the hemoglobin concentration of a single target cell. (See PGPub [0070] of the instant spec).
Claim 22 1st line “the processor” has no antecedent basis.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 (page 46) recites, “at step (7IA4), … obtained at step (7IA3)”, in which “step (7IA4)” and “step (7IA3)” has not been defined. Claim 12 further recites, “at step (8DA4), … obtained at step (8DA3)”, in which “step (8DA4)” and “step (8DA3)” has not been defined.
Claim 13 (page 47) recites, “at step (7IA4), … obtained at step (7IA3)”, in which “step (7IA4)” and “step (7IA3)” has not been defined. Claim 13 further recites, “at step (8DA4), … obtained at step (8DA3)”, in which “step (8DA4)” and “step (8DA3)” has not been defined.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 22 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Per claim 22, based upon consideration of all of the relevant factors with respect to the claim as a whole, claim 22 held to claim a readable storage medium storing a computer program. The readable storage medium does not preclude signals or carrier waves from serving as said medium, and is therefore rejected as ineligible subject matter. See paragraph [0024] (PGPub), which merely mentions readable storage medium and does not preclude "signal" per se. The broadest reasonable interpretation of the claim covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. 101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. 101, Aug. 24, 2009; p. 2.
Comments on 35 U.S.C. 101 Abstract Idea
In the following comments regarding 35 U.S.C. 101 abstract idea with respect to independent claims are presented.
Claims 1 and 21-22
In claim 1, steps (6A), (6B), (6IA3) can be practically practiced mentally under broadest reasonable interpretation. Steps (6C), (6J), (6L), (6IA4), (6IA5), (6IA6) and (6IA7) recite mathematical concepts, either in the form of mathematical formulas/equations, or mathematical calculations. Steps (6I), (6K), (6IA1) and (6IA2) are considered additional elements. Steps (6I) and (6K) merely recite data gathering, which is insignificant extra-solution activity. Steps (6IA1) and (6IA2), however, apply or use the judicial exception in a meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Specifically, the additional elements in steps (6IA1) and (6IA2), when combined with other elements of the claim, enable hemoglobin analysis to be performed in cellular level in an accurate and invasive manner (PGPub [0005-0007]). Claim 1 is eligible.
Claims 21-22 recite similar steps and therefore are eligible.
Claim 14
In claim 14, steps (6A), (6B) and (7IA3) can be practically practiced mentally under broadest reasonable interpretation. Steps (6C), (7J), (7IA4), (7IA5), and (7IA7) recite mathematical concepts, either in the form of mathematical formulas/equations, or mathematical calculations. Steps (7I), (7K), (7IA1), (7IA2) and (7IA6) are considered additional elements. Steps (7I), (7K) and (7IA6) merely recite data gathering, which is insignificant extra-solution activity. Steps (7IA1) and (7IA2), however, apply or use the judicial exception in a meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Specifically, the additional elements in steps (7IA1) and (7IA2), when combined with other elements of the claim, enable hemoglobin analysis to be performed in cellular level in an accurate and invasive manner (PGPub [0005-0007]). Claim 14 is eligible.
Claim 16
In claim 16, steps (6A), (6B) and (8DA3) can be practically practiced mentally under broadest reasonable interpretation. Steps (6C), (8E), (8DA4), (8DA5) and (8DA6) recite mathematical concepts, either in the form of mathematical formulas/equations, or mathematical calculations. Steps (8D), (8AD1), (8AD2) are considered additional elements. Step (8D) merely recites data gathering, which is insignificant extra-solution activity. Steps (8DA1) and (8DA2), however, apply or use the judicial exception in a meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Specifically, the additional elements in steps (8DA1) and (8DA2), when combined with other elements of the claim, enable hemoglobin analysis to be performed in cellular level in an accurate and invasive manner (PGPub [0005-0007]). Claim 16 is eligible.
Claim 20
In claim 20, steps (9A) and (6IA3) can be practically practiced mentally under broadest reasonable interpretation. Steps (9C), (9J), (9L), (6IA4), (6IA5) and (6IA7) recite mathematical concepts, either in the form of mathematical formulas/equations, or mathematical calculations. Steps (9I), (9K), (6IA1), (6IA2) and (6IA6) are considered additional elements. Steps (9I), (9K) and (6IA6) merely recite data gathering, which is insignificant extra-solution activity. Steps (6IA1) and (6IA2), however, apply or use the judicial exception in a meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Specifically, the additional elements in steps (6IA1) and (6IA2), when combined with other elements of the claim, enable hemoglobin analysis to be performed in cellular level in an accurate and invasive manner (PGPub [0005-0007]). Claim 20 is eligible.
Allowable Subject Matter
Claims 1-11 and 14-21 are allowed. Claims 12-13 would be allowable if the 35 U.S.C. 112b rejection is overcome, and claim 22 would be allowable if the 35 U.S.C. 101 rejection is overcome.
The following is a statement of reasons for the indication of allowable subject matter.
The present application is directed to methods, device and medium for hemoglobin analysis. Prior art, either applied alone or in combination with, fails to disclose or suggest the limitations recited in the independent claims.
The following prior art is considered the closest to the current application.
Lee et al. (US 20220170842 A1, hereafter Lee) discloses system and method for measuring/calculating cell absorbance. Specifically, the method detects a first intensity (I) of light penetrating the inside of the cell boundary region, detects a second light intensity (Io), which is the intensity of light penetrating the outside of the cell boundary region, and calculates cell absorbance using formula A=−log(I/Io). Lee further teaches using the measured cell absorbance to distinguish monolayer cell region or overlapped cell region. See FIG. 13-15, para. [0092]-[0096].
Pollak et al. (US 20150316477 A1, hereafter Pollak) discloses system and method for imaging a blood sample (Abstract). The method includes introducing a cell suspension including red blood cells onto a base surface of a carrier having a vertical height (H) being greater than or equal to a vertical depth (h) of the cell suspension when on the base carrier, the cell suspension including a cell concentration (C) being determined by a defined function; allowing the cells in the cell suspension to settle on the base surface of the carrier to form a monolayer of cells thereon; and acquiring at least one microscope image of at least a portion of the monolayer of cells; wherein the at least one microscope image is obtained by a microscope set to Depth Of Field that is not more than 20% of the vertical height of the cell suspension settled on the base surface. Pollak further teaches cell counting and calculating cell concentration based on the acquired microscope images. See Abstract, FIG. 1A-1B, para. [0022]-[0036].
Egelberg et al. (US 20140113323 A1, hereafter Egelberg) discloses a method for determining parameters of at least one erythrocyte (Abstract). The method comprises constructing an interference pattern comprising a wave front representative of said at least one erythrocyte arised from the interaction of said at least one erythrocyte and electromagnetic radiation, reconstructing amplitude- and phase information representative of said at least one erythrocyte wave front from said interference pattern and determining the mean corpuscular volume and/or mean corpuscular hemoglobin concentration and/or oxygen saturation and/or mean corpuscular hemoglobin of at least one erythrocyte by combining phase information and amplitude information representative of said at least one erythrocyte (Abstract). Specifically, Egelberg calculates cell absorbance, mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC), and mean corpuscular hemoglobin (MCH) of an erythrocyte. See para. [0041], [0050] and [0053].
Conclusion
Prior art searched bot not cited is considered related to the current application and is recorded in PTO-892.
Additional prior art Fine et al. (US 20160187235 A1) discloses a method for calculating mean corpuscular hemoglobin in red blood cells (Abstract). The method includes generating a diluted sample based on mixing a small sample of blood with a one or more diluents, forming a thin film of the diluted sample on the surface of a contact optical microscopy sensor, illuminating the red blood cells within a portion of the thin film of the diluted sample using light of a predetermined wavelength, and acquiring one or more images of the diluted sample based on illuminating the red blood cells within the portion of the thin film of the diluted sample. The acquired one or more images of the diluted sample are then processed. The mean corpuscular hemoglobin in the red blood cells within the portion of the thin film of the diluted sample is determined based on processing the acquired images of the diluted sample. Calculation of the mean corpuscular hemoglobin involves evaluation of cell absorbance. See Abstract, para. [0030]-[0044].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XUEMEI G CHEN whose telephone number is (571)270-3480. The examiner can normally be reached Monday-Friday 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, John M Villecco can be reached on (571) 272-7319. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/XUEMEI G CHEN/Primary Examiner, Art Unit 2661
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