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 filed 06/21/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Interpretation
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.
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.
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 is: a control unit in claims 1 and 9.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is 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 limitation 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 § 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.
Claim limitation “control unit” in claims 1 and 9 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification and drawings fail to add any corresponding structure and just build on to what the control unit does. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 9 is 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 9 recites the limitation "said blood sample" in line. As this claim is written as an independent claim, there is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Bamberg (US20080297769A1).
Regarding claim 1, Bamberg teaches a method for the optical evaluation of the level of hemolysis in a blood sample (Example 2 - paragraphs [0057]-[0062] disclose the method being used for hemolysis detection), said method comprising the steps of:
- prearranging a device for the optical evaluation of the level of hemolysis (120, Fig. 3) comprising:
- a light emitter (124, Fig. 3);
- at least two photodetectors (140, Fig. 3; paragraph [0056] discloses the detector is a photodiode, which is a type of photodetector; paragraph [0043] discloses the detection system may detect one or more wavelengths. The examiner is interpreting this to mean there may be one or more photodiodes in the detection system);
- a control unit arranged to receive data from said photodetectors (paragraph [0045] discloses a computer which receives data from the photodiode);
- prearranging a blood sample to be analysed (test tube with blood- 100, Fig. 1);
- emitting, by said light emitter, an inspection electromagnetic radiation towards said blood sample (Fig. 3 depicts the radiation (thick, solid line) emitting from the light emitter (124) towards the blood sample (11)), said inspection electromagnetic radiation comprising a plurality of inspection electromagnetic waves having respective wavelengths
λ
E
(paragraph [0013] discloses at least two wavelengths);
- receiving, by said photodetectors, a return electromagnetic radiation coming from said blood sample (Fig. 3 depicts a detection system (140) which includes photodiodes (paragraph [0056]) receiving radiation (thick, solid line) which comes from the blood sample (100)), said return electromagnetic radiation comprising a plurality of return electromagnetic waves having respective wavelengths
λ
R
(paragraph [0043] discloses the detection system detects one or more wavelengths);
- generating, by said photodetectors, two respective electric signals associated with return electromagnetic waves (this is the definition of what a photodetector does) having wavelengths of interest
λ
R
1
*
and
λ
R
2
*
(Fig. 10 depicts at least two wavelengths investigated; paragraph [0018] discloses how the transmittance of two wavelengths is used to determine a characterisitc of a blood sample), said electric signals generated having an intensity of current or a voltage proportional to said return electromagnetic waves having said wavelengths of interest
λ
R
1
*
and
λ
R
2
*
(Figs. 4 and 5 disclose the signal is measured as a voltage; paragraph [0056] discloses the photodiode receives the intensity of transmitted light and gives of a voltage signal);
- calculating, by said control unit, a value of the level of hemolysis in said blood sample on the basis of said electric signals generated (paragraph [0045] discloses a computer determines the characteristic of a blood sample; paragraphs [0057]-[0062] disclose how the method may be used to determine hemolysis).
Bamberg does not disclose the control unit is arranged to operate said light emitter. However, Bamberg teaches a method which involves a computer in communication with the optical evaluation device (152, Fig. 3; paragraph [0045]). A person having ordinary skill in the art would be familiar with a computer as they are widely used and well-known, and would also have the skill to modify the computer to operate the light emitter with a reasonable expectation of success. A person of ordinary skill in the art would want to modify the computer taught in Bamberg to be capable of controlling the light emitter as computers are well-known and widely used to make devices more user friendly by centralizing control.
A person of ordinary skill in the art would find it obvious to modify the computer taught in Bamberg to control the light emitter as a way to centralize control of the device and make the device more user friendly.
Regarding claim 2, Bamberg teaches the invention as described above in claim 1, but Bamberg does not explicitly disclose a step of modulating the intensity of said inspection electromagnetic radiation as a function of said level of hemolysis calculated, the modulating step ending when
the intensity of said inspection electromagnetic radiation has a predetermined value associated with the value of the level of hemolysis calculated.
However, Bamberg does teach the use of three wavelengths that were decided on based on a range tested and found to have the optimal absorption (paragraph [0057]). Bamberg further teaches the absorption of the light affects the intensity (paragraph [0058]), thus the intensity is varied until an optimal value is found. The disclosed and prior art structures (light modulator) are not identical, but the prior art performs the same task of varying the intensity of the light.
Bamberg further uses the found wavelengths to determine different ratios of intensity corresponding to different hemolysis levels (Fig. 10), which were determined by comparing the ratio to a predetermined value (paragraph [0018]).
Regarding claim 3, Bamberg teaches the invention as described above in claim 1, and further teaches said wavelengths of interest
λ
R
1
*
and
λ
R
2
*
are comprised between 400 and 600 nm (paragraph [0057] discloses five different wavelengths used for hemolysis detection: 480 nm, 515 nm, 540 nm, 560 nm, and 575 nm; paragraph [0062] discloses a specific application of two wavelengths: 565 nm and 570 nm)).
Regarding claim 4, Bamberg teaches the invention as described above in claim 1, and further teaches said wavelength of interest
λ
R
1
*
is comprised between 520 and 550 nm and wherein said wavelength of interest
λ
R
2
*
is comprised between 550 and 590 nm (paragraph [0057] discloses five different wavelengths used for hemolysis detection: 480 nm, 515 nm, 540 nm, 560 nm, and 575 nm; paragraph [0062] discloses a specific application of two wavelengths: 565 nm and 570 nm).
Regarding claim 5, Bamberg teaches the invention as described above in claim 4, and further teaches in said step of calculating, said value of the level of hemolysis is a value inversely proportional to said intensity of current or to said voltage of said electric signals generated (paragraph [0018] discloses how the ratio between the signals resulting from two different wavelengths is used to find the characteristic of blood investigated. Paragraph [0058] discloses using the slope (ratio) of the signal is used to determine the level of hemolysis. Paragraph [0015] discloses the ratio of the first signal to the second signal or the ratio of the second signal to the first signal may be used. The examiner is interpreting this to mean the level of hemolysis is inversely proportional to at least of the intensity signals).
Regarding claim 6, Bamberg teaches the invention as described above in claim 1, and further teaches said wavelength of interest
λ
R
1
*
is about 415 nm (paragraph [0057] discloses one of the wavelengths used for hemolysis detection is 480 nm. The examiner is interpreting this to be "about" 415 nm) and wherein said wavelength of interest
λ
R
2
*
is comprised between 520 and 550 nm (paragraph [0057] discloses one of the wavelenghts used for hemolysis detection is 540 nm).
Regarding claim 7, Bamberg teaches the invention as described above in claim 6, and further teaches said value of the level of hemolysis is a value directly proportional to said intensity of current or to said voltage of said electric signals generated (paragraph [0018] discloses how the ratio between the signals resulting from two different wavelengths is used to find the characteristic of blood investigated. Paragraph [0058] discloses using the slope (ratio) of the signal is used to determine the level of hemolysis. Paragraph [0015] discloses the ratio of the first signal to the second signal or the ratio of the second signal to the first signal may be used. The examiner is interpreting this to mean the level of hemolysis is directly proportional to at least of the intensity signals).
Regarding claim 9, Bamberg teaches a device for the optical evaluation of the level of hemolysis (Example 2 - paragraphs [0057]-[0062] disclose the device being used for hemolysis detection) comprising:
- a light emitter (124, Fig. 3) arranged to emit an inspection electromagnetic radiation towards said blood sample (Fig. 3 depicts the radiation (thick, solid line) emitting from the light emitter (124) towards the blood sample (11), said inspection electromagnetic radiation comprising a plurality of inspection electromagnetic waves having respective wavelengths
λ
E
(paragraph [0013] discloses at least two wavelengths);
- at least two photodetectors (140, Fig. 3; paragraph [0056] discloses the detector is a photodiode, which is a type of photodetector; paragraph [0043] discloses the detection system may detect one or more wavelengths. The examiner is interpreting this to mean there may be one or more photodiodes in the detection system) arranged to:
- receive a return electromagnetic radiation coming from said blood sample (Fig. 3 depicts a detection system (140) which includes photodiodes (paragraph [0056]) receiving radiation (thick, solid line) which comes from the blood sample (100)), said return electromagnetic radiation comprising a plurality of return electromagnetic waves having respective wavelengths
λ
R
(paragraph [0043] discloses the detection system detects one or more wavelengths);
- generate two electric signals (this is the definition of what a photodetector does) associated with return electromagnetic waves having wavelengths of interest
λ
R
1
*
and
λ
R
2
*
(Fig. 10 depicts at least two wavelengths investigated; paragraph [0018] discloses how the transmittance of two wavelengths is used to determine a characteristic of a blood sample), said electric signals generated having an intensity of current or a voltage proportional to said return electromagnetic waves having said wavelengths of interest
λ
R
1
*
and
λ
R
2
*
(Figs. 4 and 5 disclose the signal is measured as a voltage; paragraph [0056] discloses the photodiode receives the intensity of transmitted light and gives of a voltage signal);
a control unit (computer - 152, Fig. 3) arranged to:
- operate said light emitter (Bamberg does not disclose whether the computer operates the light emitter, but it is the position of the examiner that a person of ordinary skill in the art would find it obvious and routine to use the computer to control the light emitter) and receive data from said photodetectors (paragraph [0045] discloses a computer receives the signal and determines the characteristic of a blood sample; ;
- calculate a value of the level of hemolysis in said blood sample on the basis of said electric signals generated (paragraphs [0057]-[0062] disclose how the method may be used to determine hemolysis).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bamberg (US20080297769A1) as applied to claim 1 above, and further in view of Lindberg (WO0117421A1).
Regarding claim 8, Bamberg teaches the invention as explained above in claim 1, but Bamberg fails to teach said device for the optical evaluation comprises a wireless antenna and wherein a step is provided of emitting, by said wireless antenna, data concerning said evaluation of the value of the level of hemolysis in said blood sample.
However, in the same field of endeavor of optical measurement of blood characteristics, Lindberg teaches a device which includes a wireless communication device(page 16, fourth full paragraph also discloses a transmitter and receiver, which the examiner is interpreting to this to be an antenna) used to send the measured values.
It would be obvious for a person having ordinary skill in the art prior to the effective filing date to combine the method of Bamberg with the wireless antenna taught in Lindberg as wireless communication allows for broadening the use of the method by making it more user friendly (Lindberg: page 20, fourth full paragraph)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexandria Mendoza whose telephone number is (571)272-5282. The examiner can normally be reached Mon - Thur 9:00 - 6:00 CDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Uzma Alam can be reached at (571) 272-3995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDRIA MENDOZA/Examiner, Art Unit 2877
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2877