DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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 Amendment
2. According to the Preliminary Amendment, filed 22 January 2024, the status of the claims is as follows:
Claims 1-3, 5, 7-11, and 13 are currently amended;
Claims 4, 6, 12, and 14 are as originally filed; and
Claims 15-17 are new.
Claim Objections
3. Claims 1 and 10 are objected to because of the following informalities:
In Claim 1, line 29-30, “a method for predicting total iron (mg) and total Hb (g) in a unit of packed red blood cells (pRBC), comprising combining the methods according to parts A) and B) above” is a typographical error, and should be amended to “(C) a method for predicting total iron (mg) and total Hb (g) in a unit of packed red blood cells (pRBC), comprising combining the methods according to parts A) and B) above” in order to be consistent with limitations “A) …” and “B) …” in lines 2 and 16; and
In Claim 10, line 2, “automated, such as” is a typographical error, and should be amended to “automated.
Appropriate correction is required.
Claim Interpretation
4. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
5. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
6. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a data recording device” in claim 8, which corresponds to the structure of “a bar code scanner” (see page 14 of the Specification, filed 22 January 2024).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
7.. 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.
8. Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more.
Step 1 of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.03):
Claims 1-11 and 15-17 are directed to a “method”, which describes one of the four statutory categories of patentable subject matter, i.e. a process. Claim 12 are directed to a “apparatus”, which describes one of the four statutory categories of patentable subject matter, i.e. a machine. Claim 14 is directed to a “computer-readable medium”, which describes one of the four statutory categories of patentable subject matter, i.e. a machine.
Claim 13 is directed to a “computer program”, which does not describe one of the four statutory categories of patentable subject matter. MPEP 2106.03(I) states the following:
Non-limiting examples of claims that are not directed to any of the statutory categories include:
• Products that do not have a physical or tangible form, such as information (often referred to as “data per se”) or a computer program per se (often referred to as “software per se”) when claimed as a product without any structural recitations; …
A “computer program” is software per se and not directed to any of the statutory categories.
Step 2A of the Revised Patent Subject Matter Eligibility Guidance (see MPEP 2106.04):
Claim(s) 1, 3, and 15 recite the following mental process:
A) a method for predicting total Hb (g) in a unit of packed red blood cells (pRBC), comprising:
…
b) predicting total Hb (g) in said unit using the following equation
β0 + Unit volume (mL)β1 + Hb Fingertip (g/dL) β2 + xi3β3 + xi4β4
+ xi5β5 + xi6β6,
wherein
β0 = (-33.97164897288266); β1 = 0.263; β2 = 0.893;
β3 = (-0.386); β4 = 0.386,
β5 = (-0.371); β6 = 0.371, and
xi3 = 1 if female, else 0; xi4 = 1 if male, else 0, xi5 = 1 if blood bag system CQ42271 FRESENIUS KABI DEUTSCHLAND GMBH else 0; xi6 = 1 if blood bag system LQT7248LC MACO PHARMA INT. GMBH else 0;
B) a method for predicting total iron (mg) in a unit of packed red blood cells (pRBC), comprising
…
b) predicting total iron (mg) in said unit using the following equation
β
0
+
U
n
i
t
v
o
l
u
m
e
m
L
β
1
+
H
b
F
i
n
g
e
r
t
i
p
g
d
L
β
2
+
x
i
3
β
3
+
x
i
4
β
4
+
x
i
5
β
5
+
x
i
6
β
6
*
4
F
e
*
55.845
g
m
o
l
64.458
g
/
m
m
o
l
wherein
β0 = (-33.97164897288266); β1 = 0.263; β2 = 0.893;
β3 = (-0.386); β4 = 0.386,
β5 = (-0.371); β6 = 0.371, and
xi3 = 1 if female, else 0; xi4 = 1 if male, else 0, xi5 = 1 if blood bag system CQ42271 FRESENIUS KABI DEUTSCHLAND GMBH else 0; xi6 = 1 if blood bag system LQT7248LC MACO PHARMA INT. GMBH else 0; and
a method for predicting total iron (mg) and total Hb (g) in a unit of packed red blood cells (pRBC), comprising combining the methods according to parts A) and B) above.
Based on broadest reasonable interpretation, these limitations are directed to receiving data and performing a mathematical operation, which can be done mentally or using the assistance of pen and paper.
This abstract idea is not integrated into a practical application because the additional limitations of “a) obtaining data for i) the volume (mL) of the unit, ii) the concentration of Hb Fingertip (g/dL), iii) the sex of the donor, and iv) type of blood bag system of the pRBC,” in claims 1, 3, and 15, add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process.
Step 2B of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.05):
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, when considered separately and in combination.
Analyzing the additional claim limitations individually, the additional limitations that are not directed to the mental process are “a) obtaining data for i) the volume (mL) of the unit, ii) the concentration of Hb Fingertip (g/dL), iii) the sex of the donor, and iv) type of blood bag system of the pRBC,” in claims 1, 3, and 15, “wherein the data in step a) is obtained by a data recording device” in claim 8, “receiving the data in step a), followed by the predicting according to step b)” in claim 11, and “wherein the recording device is a bar code scanner” in claim 16. Such features are add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the abstract idea.
The limitations “a calculator” in claim 6, “wherein said method is automated, such as” in claim 10, “which is a computer-implemented method” in claim 11, “A data processing apparatus comprising means for carrying out the method of …” in claim 12, “A computer-readable medium stored thereon the computer program of …” in claim 14, and “wherein the method is performed by a robot” in claim 17, are merely parts of a computer to be used as a tool to perform the mental process, and amounts to computer implementation of the abstract idea.
The additional limitations of dependent claims 2, 4, 5, 6, 7, and 9 are merely directed to and further narrow the scope of the mental process or further narrow the scope of the additional limitations that do not integrate the mental process into a practical application or are not significantly more than the mental process. Based on broadest reasonable interpretation, these limitations are directed to receiving data and performing a mathematical operation, which can be done mentally or using the assistance of pen and paper.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide computer implementation of the abstract idea using collected data without: improvement to the functioning of a computer or to any other technology or technical field; applying the mental process with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; applying or using the mental process in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment; or adding a specific limitation other than what is well-understood, routine, conventional activity in the field.
Claim Rejections - 35 USC § 112
9. 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.
10. Claims 1-17 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 1, lines 13-15 and 26-28, claim 3, lines 11-13, and claims 5, lines 12-15, recite the limitation “xi5 = 1 if blood bag system CQ42271 FRESENIUS KABI DEUTSCHLAND GMBH else 0; xi6 = 1 if blood bag system LQT7248LC MACO PHARMA INT. GMBH else 0”. It is not clear what structural element that the phrase “blood bag system CQ42271 FRESENIUS KABI DEUTSCHLAND GMBH” and “LQT7248LC MACO PHARMA INT. GMBH” is attempting to describe.
Claims 2-17 are rejected due to their dependencies to base claim 1.
Examiner’s Comment
11. The prior art of record does not teach the limitations of base claim 1. However, claims 1-17 are directed to non-patentable subject matter as discussed in the above rejection. Therefore, no indication of allowability will be provided at this time.
The closest prior art reference is Zhang et al., U.S. Patent Application Publication No. 2013/0144139 A1 (“Zhang”). Zhang teaches a method for calculating haemoglobin in a hose line of an extracorporeal blood circuit (see para. [0010]), the method including determining the concentration of Haemoglobin (Hb) using the equation:
Hb = a*S(Qbk)-b (equation 1)
wherein a and b are constants, which are ascertained in a basic calibration of measuring arrangement 15 carried out in the factory in the presence of a calibration blood flow rate Q.sub.bk. S(Q.sub.bk) is the measurement signal correlating with the side-scattering in the calibration of the measuring arrangement carried out in the factory.
However, neither Zhang nor the prior art of record teaches the following:
A) a method for predicting total Hb (g) in a unit of packed red blood cells (pRBC), comprising:
…
b) predicting total Hb (g) in said unit using the following equation
β0 + Unit volume (mL)β1 + Hb Fingertip (g/dL) β2 + xi3β3 + xi4β4
+ xi5β5 + xi6β6,
wherein
β0 = (-33.97164897288266); β1 = 0.263; β2 = 0.893;
β3 = (-0.386); β4 = 0.386,
β5 = (-0.371); β6 = 0.371, and
xi3 = 1 if female, else 0; xi4 = 1 if male, else 0, xi5 = 1 if blood bag system CQ42271 FRESENIUS KABI DEUTSCHLAND GMBH else 0; xi6 = 1 if blood bag system LQT7248LC MACO PHARMA INT. GMBH else 0;
B) a method for predicting total iron (mg) in a unit of packed red blood cells (pRBC), comprising
…
b) predicting total iron (mg) in said unit using the following equation
β
0
+
U
n
i
t
v
o
l
u
m
e
m
L
β
1
+
H
b
F
i
n
g
e
r
t
i
p
g
d
L
β
2
+
x
i
3
β
3
+
x
i
4
β
4
+
x
i
5
β
5
+
x
i
6
β
6
*
4
F
e
*
55.845
g
m
o
l
64.458
g
/
m
m
o
l
wherein
β0 = (-33.97164897288266); β1 = 0.263; β2 = 0.893;
β3 = (-0.386); β4 = 0.386,
β5 = (-0.371); β6 = 0.371, and
xi3 = 1 if female, else 0; xi4 = 1 if male, else 0, xi5 = 1 if blood bag system CQ42271 FRESENIUS KABI DEUTSCHLAND GMBH else 0; xi6 = 1 if blood bag system LQT7248LC MACO PHARMA INT. GMBH else 0; and
a method for predicting total iron (mg) and total Hb (g) in a unit of packed red blood cells (pRBC), comprising combining the methods according to parts A) and B) above.
Specifically, neither Zhang nor the prior art of record teaches using the above equations for predicting total iron and total Hb(g) in a unit of packed pRBC.
Conclusion
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 07/22/2026
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