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 Group I, claims 1-12 and newly added claims 21-23, drawn to a system for real-time detecting cancer by analyzing unprocessed blood in the reply filed on October 8, 2025 is acknowledged.
Priority
This application is a continuation-in-part of International Patent Application PCT/IB2022/051283, which takes priority from U.S. Provisional Patent Application Ser. No. 63/149,282 (PGpub ¶1), and thus the priority date of this application is December 29, 2022.
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.
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:
"an electrical stimulator-analyzer device" in claim 1.
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. The specification states that the electrical stimulator-analyzer device 104 may include a potentiostat device (Fig. 1; ¶61).
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 § 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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 1-12 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miripour (Z. S. Miripour, Electrochemical measuring of reactive oxygen species levels in the blood to detect ratio of high-density neutrophils, suitable to alarm presence of cancer in suspicious cases, Journal of Pharmaceutical and Biomedical Analysis, 2022(209), 114488, pp. 1-8) in view of Abdolanhad (WO 2021/214537).
Regarding claim 1, Miripour teaches a system for real-time detecting cancer by analyzing unprocessed blood ([Abstract]: a real-time electrochemical assay), comprising:
a sensor (Fig. 1: VAMWCNT bases biosensors), comprising:
a substrate (Fig. 1(a): P-type Si wafer 100); and
three electrodes formed on the substrate (Fig. 1(d)), the three electrodes comprising a working electrode, a counter electrode, and a reference electrode (p. 2, col. 1, para. 6: WE, CE, and RE), each respective electrode comprising:
an electrically conductive layer deposited on the substrate, the electrically conductive layer comprising a proximal end and a circular distal end (Fig. 1(d): each electrode on the substrate having a proximal end on the peripheral of the substrate and a circular distal end in the middle); and
an array of multi-walled carbon nanotubes (VAMWCNTs) grown on the circular distal end (Fig. 1(f)-(h)), the array of VAMWCNTs configured to be put in contact with an unprocessed blood sample dropped on surface of the sensor ([Abstract]: on unprocessed blood), the unprocessed blood sample being drawn from a suspected person to have cancer ([Abstract]: to detect the presence of cancer in patients; Examiner notes here the unprocessed blood is material or article worked upon. "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Young, 75 F.2d. 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)). MPEP 2115);
an electrical stimulator-analyzer device (p. 2, col. 2, para. 2: the readout system) electrically connected to the sensor at the respective proximal end of each respective electrode of the three electrodes (p. 2, col. 2, para. 2: the pads were attached to an electrical connector with three pins by conductive paste to form the final sensor and connected to the readout system by a noiseless cable that handled all three electrodes), the stimulator-analyzer device configured to:
apply a set of voltages in a sweeping range from -0.8 V to +0.8 V to the sensor comprising the VAMWCNTs being in contact with the unprocessed blood sample (Fig. 1(l): the voltage is from -800 mV to 800 mV); and
measure a produced set of electrical currents of the sensor responsive to the applied set of voltages (Fig. 1(l): the recorded current over the applied voltage range).
Miripour does not disclose a processing unit electrically connected to the electrical stimulator-analyzer device, the processing unit comprising: a memory having processor-readable instructions stored therein; and a processor configured to access the memory and execute the processor-readable instructions, which, when executed by the processor configures the processor to perform a method, the method comprising: applying, utilizing the stimulator-analyzer device, the set of voltages in the sweeping range from -0.8 V to +0.8 V between the reference electrode and the working electrode; measuring, utilizing the stimulator-analyzer device, the produced set of electrical currents between the counter electrode and the working electrode; measuring a level of a ratio of low-density neutrophils (LDNs) to high-density neutrophils (HDNs) in the unprocessed blood sample by measuring a level of reactive oxygen species (ROS) in the unprocessed blood sample, measuring the level of ROS in the unprocessed blood sample comprising measuring a maximum electrical current of the measured set of electrical currents; and detecting cancer status of the suspected person, comprising: detecting a cancer disease in suspected person's body if the measured ratio of LDNs to HDNs in the unprocessed blood sample is more than 1 by detecting the measured maximum electrical current of the measured set of electrical currents being less than a first threshold electrical current value; or 60 detecting no cancer disease in the suspected person's body if the measured ratio of LDNs to HDNs in the unprocessed blood sample is less than 1 by detecting the measured maximum electrical current of the measured set of electrical currents being more than a second threshold electrical current value.
However, Abdolanhad teaches a system for diagnosing COVID-19 infection (¶6). The system includes an electrochemical probe 402, an electrochemical stimulator-analyzer 404 electrically connected to the electrochemical probe, and a processing unit 406 electrically connected to the electrochemical stimulator-analyzer (Fig. 4A; ¶45). The processing unit may include a memory having processor-readable instructions stored therein, and a processor, which may be configured to access the memory and execute the processor-readable instructions, and perform a method by executing the processor-readable instructions (¶6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miripour by incorporating a processing unit comprising a memory and a processor as taught by Abdolanhad because it enables a computer system to implement computer-readable code according to the computer readable instructions to perform the programmed instructions (¶69). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
The designation “configured to access the memory and execute the processor- readable instructions, which, when executed by the processor configures the processor to perform a method, the method comprising: applying, utilizing the stimulator-analyzer device, the set of voltages in the sweeping range from -0.8 V to +0.8 V between the reference electrode and the working electrode; measuring, utilizing the stimulator-analyzer device, the produced set of electrical currents between the counter electrode and the working electrode; measuring a level of a ratio of low-density neutrophils (LDNs) to high-density neutrophils (HDNs) in the unprocessed blood sample by measuring a level of reactive oxygen species (ROS) in the unprocessed blood sample, measuring the level of ROS in the unprocessed blood sample comprising measuring a maximum electrical current of the measured set of electrical currents; and detecting cancer status of the suspected person, comprising: detecting a cancer disease in suspected person's body if the measured ratio of LDNs to HDNs in the unprocessed blood sample is more than 1 by detecting the measured maximum electrical current of the measured set of electrical currents being less than a first threshold electrical current value; or 60 detecting no cancer disease in the suspected person's body if the measured ratio of LDNs to HDNs in the unprocessed blood sample is less than 1 by detecting the measured maximum electrical current of the measured set of electrical currents being more than a second threshold electrical current value” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Miripour teaches all structural limitations of the presently claimed system that measuring current response signals using cyclic voltammogram (Fig. 1: voltage sweeping from -800 mV to 800mV for recording the current in response to the voltage) to detect the presence of cancer by an increased ratio of LDNs with reduced ROS release in circulating blood (Fig. 2(a); p. 2, col. 1, para. 5), and thus is capable of performing the recited method.
Regarding claims 2-5, the designations “wherein detecting the cancer disease in the suspected person's body comprises one of detecting the cancer disease in the suspected person's body if the suspected person's body is an adult responsive to the measured maximum electrical current of the measured set of electrical currents being less than 300 µA corresponding to a ratio of LDNs to HDNs in the unprocessed blood sample being more than 1; or detecting the cancer disease in the suspected person's body if the suspected person's body is a child responsive to the measured maximum electrical current of the measured set of electrical currents being less than 100 µA corresponding to a ratio of LDNs to HDNs in the unprocessed blood sample being more than 1” in claim 2, “wherein detecting no cancer disease in the suspected person's body comprises one of detecting no cancer disease in the suspected person's body if the suspected person's body is an adult responsive to the measured maximum electrical current of the measured set of electrical currents being more than 450 µA corresponding to a ratio of LDNs to HDNs in the unprocessed blood sample being less than 1; or detecting no cancer disease in the suspected person's body if the suspected person's body is a child responsive to the measured maximum electrical current of the measured set of electrical currents being more than 300 µA corresponding to a ratio of LDNs to HDNs in the unprocessed blood sample being less than 1” in claim 3, “wherein the method further comprises determining the first threshold electrical current value and the second threshold electrical current value, comprising: generating a first dataset of a plurality of unprocessed blood samples associated with a plurality of cancer patients, comprising: measuring a first set of electrical current peaks of the unprocessed blood samples associated with the plurality of cancer patients; measuring a first set of ratio of LDNs to HDNs in the unprocessed blood samples associated with the plurality of cancer patients utilizing a cell counter; and assigning each measured ratio of LDNs to HDNs of the first set of ratio of LDNs to HDNs to the respective measured electrical current peak of the first set of electrical current peaks; generating a second dataset of a plurality of unprocessed blood samples associated with a plurality of healthy persons, comprising: measuring a second set of electrical current peaks of the unprocessed blood samples associated with the plurality of healthy persons; measuring a second set of ratio of LDNs to HDNs in the unprocessed blood samples associated with the plurality of healthy persons utilizing a cell counter; and assigning each measured ratio of LDNs to HDNs of the second set of ratio of LDNs to HDNs to the respective measured electrical current peak of the second set of electrical current peaks; and determining the first threshold electrical current value and the second threshold electrical current value, comprising: determining the first threshold electrical current value equal to a maximum electrical current peak among the first set of electrical current peaks; and determining the second threshold electrical current value equal to a minimum electrical current peak among the second set of electrical current peaks” in claim 4, and “wherein the method is conducted in less than 30 seconds” in claim 5 are deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Miripour in view of Abdolanhad teaches all structural limitations of the presently claimed system that measuring current response signals using cyclic voltammogram (Fig. 1: voltage sweeping from -800 mV to 800mV for recording the current in response to the voltage) to detect the presence of cancer by an increased ratio of LDNs with reduced ROS release in circulating blood (Fig. 2(a); p. 2, col. 1, para. 5), and thus is capable of performing the recited method.
Regarding claim 6, Miripour and Abdolanhad disclose all limitations of claim 1. Miripour and Abdolanhad do not disclose wherein the circular distal end has a diameter in a range of 0.5 mm to 3 mm.
However, Miripour teaches three electrodes in the shape of 3 circles with a diameter of 2 mm (p. 2, col. 2, para. 2), which lies in the recited range.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miripour and Abdolanhad by adjusting diameter of the disc electrode within the recited range because in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I).
Regarding claim 7, Miripour and Abdolanhad disclose all limitations of claim 1. Miripour and Abdolanhad do not disclose wherein the three respective circular distal ends of the three electrodes are placed apart from each other by a distance between 1 mm and 5 mm.
However, Miripour teaches wherein the three respective circular distal ends of the three electrodes are placed apart from each other by a distance between 1 mm and 5 mm (p. 2, col. 1, para. 6: with a triangular distance of 5 mm from each other).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miripour and Abdolanhad by adjusting distance between the circular distal end of each electrode within the recited range because in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I).
Regarding claim 8, Miripour teaches wherein the substrate comprises a first layer of silicon dioxide deposited on a layer of silicon (Fig. 1(a)-(d); p. 2, col. 2, para. 2: p-type Si wafer 100; the silicon dioxide layer deposited on the electrodes).
Regarding claim 9, Miripour teaches wherein the sensor further comprises a second layer of silicon dioxide deposited on surface of sensor except surface of the circular distal end and the proximal end of each respective electrode of the three electrodes (Fig. 1(e); p. 2, col. 2, para. 2: the silicon dioxide layer deposited on the electrodes was removed).
Regarding claim 10, Miripour teaches wherein the electrically conductive layer comprises a layer of nickel (Fig. 1(d); p. 2, col. 2, para. 2: the Ni layer).
Regarding claim 11, Miripour and Abdolanhad disclose all limitations of claim 1. Miripour and Abdolanhad do not disclose wherein the electrically conductive layer has a thickness in a range of 5 nm to 20 nm.
However, Miripour teaches wherein a Ni catalyst layer with a thickness of about 9 nm (p. 2, col. 2, para. 2), which lies in the recited range.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miripour and Abdolanhad by adjusting the thickness of the electrically conductive layer within the recited range because in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I).
Regarding claim 12, Miripour teaches wherein:
the array of VAMWCNTs comprises VAMWCNTs with a length in a range of 2.5 µm to 5 µm; and
the array of VAMWCNTs comprises VAMWCNTs with a diameter in a range of 50 nm to 70 nm (p. 2, col. 2, para. 2: VAMWCNT; the length and diameter of nanotubes ranged from 2.5 to 5 µm and from 50 to 70 nm respectively).
Regarding claim 21, Miripour teaches the system further comprising a holder, the holder comprising a hollow cylinder with a diameter equal to or more than an outer diameter of the sensor (Fig. 2(a): the ROS/H2O2 sensor inside a holder), the holder configured to protect the sensor and the unprocessed blood sample dropped thereon, wherein the unprocessed blood sample is dropped inside the holder on the surface of the sensor (Fig. 2(a): the blood is on the surface of the sensor and inside the holder).
The designation “configured to protect the sensor and the unprocessed blood sample dropped thereon” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Miripour in view of Abdolanhad teaches all structural limitations of the presently claimed system including a holder surrounding the outer diameter of the sensor, and thus it is capable of protecting the sensor and the unprocessed blood sample dropped thereon.
Regarding claim 22, Miripour teaches the system further comprising three electrically conductive pins, each respective pin being connected to the proximal end of each electrode of the three electrodes, the three electrically conductive pins connecting the three electrodes to the electrical stimulator-analyzer device (p. 2, col. 2, para. 2: the pads were attached to an electrical connector with three pins by conductive paste to form the final sensor and connected to the readout system by a noiseless cable that handled all three electrodes).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miripour in view of Miripour, and further in view of Ray (US 2018/0364188).
Regarding claim 23, Miripour and Abdolanhad disclose all limitations of claim 21. Miripour and Abdolanhad do not disclose the system further comprising a circular cap placed on a top side of the holder, the circular cap comprising a diameter equal to or more than an outer diameter of the holder above the sensor and the unprocessed blood sample thereon, the circular cap configured to protect the sensor and the unprocessed blood sample away from pollutants and disturbing factors.
However, Ray taches a sensor array for providing detection and prognosis of various diseases ([Abstract]). The sensor assembly has a main housing 210 and a protective cap 220 to contain a circuit board assembly 230 with a sensor 240 (Fig. 2; ¶82). As shown in Fig. 2, the protective cap 220 comprising a diameter equal or more than an outer diameter of the main housing 210.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miripour and Abdolanhad by incorporating a cap having a diameter equal to or more than the outer diameter of the housing to be placed on top of the housing as taught by Ray because the cap is protective and assembles numerous components into the housing to be a compact sensor assembly (Ray, Fig. 2; ¶82). The combined Miripour, Abdolanhad, and Ray would necessarily result in the cap above the sensor being above the unprocessed blood sample thereon. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
The designation “configured to protect the sensor and the unprocessed blood sample away from pollutants and disturbing factors” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Miripour in view of Abdolanhad and Ray teaches all structural limitations of the presently claimed system including a top cap to assemble the sensor into the housing, and thus it is capable of protecting the sensor and the unprocessed blood sample away from pollutants and disturbing factors.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached M-F: 8:30am - 5:30pm.
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/C. SUN/Primary Examiner, Art Unit 1795