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 .
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.
Examiner’s Note
The Examiner has pointed out particular references contained in the prior art of record within the body of this action for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages, paragraph and figures may apply. Applicant, in preparing the response, should consider fully the entire reference as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
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(s) is/are: “computing device” in claim 15.
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 Objections
Claim(s) 1, 15 is/are objected to because of the following informalities:
In claim 1, " presenting results of the selected experiment based at least on the received spectroscopic data via the graphical user interface of the user device " in lines 10-11, should be changed to – presenting results of the selected experiment based at least on
In claim 15, " presenting results of the selected experiment based at least on the received spectroscopic data via the graphical user interface of the user device " in lines 11-12, should be changed to – presenting results of the selected experiment based at least on
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 of this title, 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.
Claim(s) 1-8 and 11-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harmon et al. (US 20060095225 A1) (herein after Harmon) in view of Goldman (US 20030003522 A1) (herein after Goldman).
As to claim(s) 1-8 and 11-20, Harmon discloses an apparatus/a method to measure blood of a user, the apparatus comprising:
a processor [FIG. 1 illustrates a system 100 that implements a computer program 112 according to an exemplary embodiment…¶0028] configured with instructions for:
presenting at least one lifestyle change experiment to a user via a graphical user interface of a user device [data source 102 may comprise any type of data input device, including but not limited to metering and measuring devices designed to test for physical characteristics. Data source 102 may further include input devices, (e.g., buttons, keys, touch screens, on screen menus, user interfaces, etc.) to input lifestyle information…¶0029];
receiving a selection of an experiment in a computing device [Processing station 106 includes a device to save and store information (e.g., a memory, a disk drive, or other removable storage device, a database, etc.) and a device to process data (e.g., a central processing unit or CPU) from data sources 102 using algorithms within and desired software, such as within program 112…Examples of visual display 110 may include, but are not limited to, a display monitor for a personal or networked computer, or a Liquid Crystal Display (LCD) screen for a personal digital assistant (PDA)…¶0030];
prompting, from the computing device and based on the selected experiment, a reminder to the user to perform a lifestyle change in accordance with the experiment [computer program 112 allows processing station 106 to accept data from data source 102, to store the incoming data as a patient file, to process the accepted and stored data using a main computer program 112 and a plurality of associated plug-ins in conjunction with a set of user-defined control options, and to generate a color-based report 114 for data interpretation that color codes the numeric results from a metering system or calculated percentages based on the numeric results from a metering system…¶0039];
prompting, from the computing device, the user to take a blood sample; processing, in the computing device [¶0028, 0033];
presenting results of the selected experiment based at least on the received data via the graphical user interface of the user device [¶0033, 0039].
[Note: while each unit configured to perform as claimed may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does].
The apparatus of claim 15, wherein the experiment comprises one or more of a metabolism experiment, a cardiovascular health experiment, an inflammation and immune function experiment, hematologic function experiment, a toxin experiment, a stress experiment, a saliva experiment, or a fecal fat experiment [such as blood glucose levels for patients with diabetes, or cholesterol levels for patients with cardiovascular disease…¶0079].
The method of claim 1, wherein prompting the user includes periodic prompts for the user to perform the lifestyle change in accordance with the experiment [¶0050].
The method of claim 1, wherein prompting the user to take the blood sample includes periodic prompts for the user to take blood samples [¶0050].
The method of claim 1, wherein the results indicate changes in health in response to the lifestyle change [¶0029].
The method of claim 1, further comprising determining a channel corresponding to the selected experiment and determining a change in the channel in response to the lifestyle change, and outputting the change in the channel to the user [¶0029, 0039].
Harmon discloses all the features of the claimed invention except the limitation such as: “data corresponding to a gravimetric separation of the blood sample;
presenting results of the selected experiment based at least on the received spectroscopic data via the graphical user interface of the user device.
The apparatus/method of claim 15, wherein the processor is configured with instructions for three or more of the metabolism experiment, the cardiovascular health experiment, the inflammation experiment, the hematologic function experiment, the toxin experiment the stress experiment, the saliva experiment or the fecal fat experiment and optionally wherein the process is configured with instructions for four or more experiments.
The apparatus/method of claim 16, wherein the processor comprises instructions for the metabolism experiment and the processor is configured with instructions to detect a change in one or more of the following channels: glucose, HbA1c (Glycated Hemoglobin), glycated albumin, ketones, β-hydroxybutyrate, albumin, total protein, blood urea nitrogen (BUN), uric acid, creatinine, glutamate, lactic acid (lactate), CO2 (bicarbonate), pH, sodium, magnesium, potassium, calcium, hydration, total body water (TBW), hematocrit, vitamin E, vitamin C, or vitamin A.
The apparatus/method of claim 16, wherein the processor comprises instructions for the cardiovascular experiment and the processor is configured with instructions to detect a change in one or more of the following channels: high density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol and other cholesterol ratios, apolipoprotein, triglycerides, or average blood pressure.
The apparatus/method of claim 16, wherein the processor comprises instructions for the inflammation experiment and the processor is configured with instructions to detects a change in one or more of the following channels: fibrinogen, C-reactive protein (CRP), uric acid, serum amyloid, globulins, IgG, IgA, IgM, or haptoglobin.
The apparatus/method of claim 16, wherein the processor comprises instructions for the hematology experiment and the processor is configured with instructions to detect a change in one or more of the following channels: hematocrit, hemoglobin, erythrocyte sedimentation rate, transferrin saturation, pyruvate, red blood cell count, white blood cell count, platelet count, or prothrombin time.
The method of claim 2, wherein the toxin experiment detects a change in one or more of the following channels: carbon monoxide, carboxyhemoglobin, ethanol, salicylates, acetominophen, ethylene glycol, or caffeine.
The method of claim 2, wherein the stress experiment is configured to detect a change in one or more of the following channels: dehydroepiandrosterone (DHEA), dehydroepiandrosterone-S (DHEA-S), creatinine, glucose, C-reactive protein (CRP), fibrinogen, HbA1c, albumin, or ethanol.”.
However, Goldman from the same field of endeavor discloses a device data corresponding to a gravimetric separation of the blood sample [¶0127, 0131] (In applicant own disclosures: The gravimetric separation of blood can also be used to obtain the blood pressure of the patient…¶0107);
presenting results of the selected experiment based at least on the received spectroscopic data via the graphical user interface of the user device [¶0128];
a processor is configured with instructions for three or more of the metabolism experiment [¶0021], the cardiovascular health experiment [¶0066], the inflammation experiment, the hematologic function experiment [¶0042], the toxin experiment the stress experiment, the saliva experiment or the fecal fat experiment and optionally wherein the process is configured with instructions for four or more experiments;
wherein the processor comprises instructions for the metabolism experiment and the processor is configured with instructions to detect a change in one or more of the following channels: glucose [¶0023], HbA1c (Glycated Hemoglobin), glycated albumin, ketones, β-hydroxybutyrate, albumin, total protein [¶0026], blood urea nitrogen (BUN), uric acid, creatinine, glutamate, lactic acid (lactate), CO2 (bicarbonate), pH, sodium, magnesium, potassium, calcium, hydration, total body water (TBW), hematocrit, vitamin E, vitamin C, or vitamin A;
the processor comprises instructions for the cardiovascular experiment and the processor is configured with instructions to detect a change in one or more of the following channels: high density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol and other cholesterol ratios, apolipoprotein, triglycerides, or average blood pressure [¶0068, 0071];
the processor comprises instructions for the inflammation experiment and the processor is configured with instructions to detects a change in one or more of the following channels: fibrinogen, C-reactive protein (CRP), uric acid, serum amyloid, globulins, IgG, IgA, IgM, or haptoglobin [¶0063, 0068];
the processor comprises instructions for the hematology experiment and the processor is configured with instructions to detect a change in one or more of the following channels: hematocrit, hemoglobin, erythrocyte sedimentation rate, transferrin saturation, pyruvate, red blood cell count, white blood cell count, platelet count, or prothrombin time [¶0051, 0132];
wherein the toxin experiment detects a change in one or more of the following channels: carbon monoxide, carboxyhemoglobin, ethanol, salicylates, acetominophen, ethylene glycol, or caffeine [¶0198];
wherein the stress experiment is configured to detect a change in one or more of the following channels: dehydroepiandrosterone (DHEA), dehydroepiandrosterone-S (DHEA-S), creatinine, glucose, C-reactive protein (CRP), fibrinogen, HbA1c, albumin, or ethanol [¶0046, 0130].
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention was made to modify the device/method/system of Harmon such that the data corresponding to the gravimetric separation of the blood sample; presenting results of the selected experiment based at least on the received spectroscopic data via the graphical user interface of the user device; the processor is configured with instructions for three or more of the metabolism experiment, the cardiovascular health experiment, the inflammation experiment, the hematologic function experiment, the toxin experiment the stress experiment, the saliva experiment or the fecal fat experiment and optionally wherein the process is configured with instructions for four or more experiments; the processor comprises instructions for the metabolism experiment and the processor is configured with instructions to detect the change in one or more of the following channels: glucose, HbA1c (Glycated Hemoglobin), glycated albumin, ketones, β-hydroxybutyrate, albumin, total protein, blood urea nitrogen (BUN), uric acid, creatinine, glutamate, lactic acid (lactate), CO2 (bicarbonate), pH, sodium, magnesium, potassium, calcium, hydration, total body water (TBW), hematocrit, vitamin E, vitamin C, or vitamin A; the processor comprises instructions for the cardiovascular experiment and the processor is configured with instructions to detect the change in one or more of the following channels: high density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol and other cholesterol ratios, apolipoprotein, triglycerides, or average blood pressure; the processor comprises instructions for the inflammation experiment and the processor is configured with instructions to detects the change in one or more of the following channels: fibrinogen, C-reactive protein (CRP), uric acid, serum amyloid, globulins, IgG, IgA, IgM, or haptoglobin; the processor comprises instructions for the hematology experiment and the processor is configured with instructions to detect the change in one or more of the following channels: hematocrit, hemoglobin, erythrocyte sedimentation rate, transferrin saturation, pyruvate, red blood cell count, white blood cell count, platelet count, or prothrombin time; wherein the toxin experiment detects the change in one or more of the following channels: carbon monoxide, carboxyhemoglobin, ethanol, salicylates, acetominophen, ethylene glycol, or caffeine; wherein the stress experiment is configured to detect the change in one or more of the following channels: dehydroepiandrosterone (DHEA), dehydroepiandrosterone-S (DHEA-S), creatinine, glucose, C-reactive protein (CRP), fibrinogen, HbA1c, albumin, or ethanol;
as taught by Goldman, for the advantages such as: accurately measure the concentration of glycosolated proteins or "protein-bound glucose" (PBG)…¶0050.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harmon et al. in view of Goldman and further in view of Smith (US 20020182600 A1) (herein after Smith).
As of claims 9-10, Harmon when modified by Goldman discloses all the features of the claimed invention except the limitation such as: “The method of claim 2, wherein the fecal fat experiment detects a change in a fecal fat channel.
The method of claim 2, wherein the saliva experiment detects a change in a cortisol channel.”.
However, Smith from the same field of endeavor discloses a fecal fat experiment detects a change in a fecal fat channel [¶0047]; a saliva experiment detects a change in a cortisol channel [¶0047, 0111].
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention was made to modify the device/method/system of Harmon when modified by Goldman such that the fecal fat experiment detects the change in the fecal fat channel; the saliva experiment detects the change in the cortisol channel; as taught by Smith, for the advantages such as: to evaluate test results and report findings rapidly and efficiently…¶0042.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MD M RAHMAN whose telephone number is (571)272-9175. The examiner can normally be reached Mon-Thur.
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MD M. RAHMAN
Primary Patent Examiner
Art Unit 2886
/MD M RAHMAN/Primary Examiner, Art Unit 2877