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
Claims 27-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/21/2026.
Claims 11-26 are hereby under examination.
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: implanted part in claim 11.
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 § 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 25 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.
Regarding claim 25, the phrase "approximate" renders the claim(s) indefinite because the range of the term is so broad, thereby rendering the scope of the claim(s) unascertainable.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 11-14, 17-18, 20-22, 24 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US20210038129A1 (Bohm et. al), hereto referred as Bohm.
As to claim 11, Bohm teaches a method for obtaining analyte concentration with temperature compensation, the analyte concentration being obtained by an analyte sensor (Fig. 42, [0454], "FIG. 42 illustrates compensating analyte concentration data measured by the sensor of Example 4 for effects of temperature after sensor run-in."), and the analyte sensor comprising an implanted part being configured to be placed subcutaneously and an application part being configured to be placed on a body surface ([0195], "generating sensor data using a subcutaneous analyte sensor") and having a temperature sensor ([0101], "the property of the sensor is a sensitivity of the sensor or a temperature of the sensor"), wherein the method comprises:
obtaining sensitivity information of the implanted part at a predetermined analyte concentration prior to the analyte sensor being worn, the sensitivity information being a relationship between a temperature and a sensitivity of the implanted part ([0398], "Pre-implant information 2402 can include any of the following types of information...[0404] patient specific relationships between sensor and sensitivity, baseline, drift, impedance, impedance/temperature relationship");
placing the implanted part subcutaneously and the application part on a body surface, obtaining a body surface temperature via the temperature sensor, and obtaining a subcutaneous temperature based on the body surface temperature (Fig. 18, [0219], "FIG. 18 is a flowchart describing a process for determining a temperature associated with a sensor by correlating an impedance measurement to a predetermined temperature-to-impedance relationship in accordance with one embodiment.");
selecting a reference temperature ([0298], "In certain embodiments, the sensor sensitivity profile may be adjusted during sensor use... patient temperature");
obtaining calibration information based on the sensitivity information, the reference temperature, and the subcutaneous temperature, and calibrating a response signal obtained by the implanted part based on the calibration information (Figs. 8, 15-18, [0322], "Each sensitivity function or calibration function results in calibrating the system for a different set of conditions."); and
obtaining the analyte concentration based on the reference temperature and the calibrated response signal (Fig. 24).
As to claim 12, Bohm teaches placing the implanted part in a reagent comprising the analyte; changing a temperature of the reagent; and measuring a variation of sensitivity of the implanted part over the temperature of the reagent to obtain sensitivity information of the implanted part ([0360], "A relationship between sensor sensitivity and different temperatures can be mathematically modeled... Sensor data can then be converted to estimated analyte concentration values based on the determined sensor sensitivity.").
As to claim 13, Bohm teaches keeping the concentration ([0430], " In many of the examples, the glucose concentration is about 100 mg/dL.") of the analyte in the reagent constant when the temperature of the reagent is changed ([0451], "The temperature was initially set and maintained at 37 C, then raised to 45 C, and finally lowered to 25 C, as indicated in FIG. 40.").
As to claim 14, Bohm teaches sensing the body surface temperature and the subcutaneous temperature of a phantom simultaneously at different environment temperatures to obtain a first mapping relationship between the body surface temperature and the subcutaneous temperature; and obtaining the subcutaneous temperature based on the body surface temperature and the first mapping relationship ([0362], "The second estimated temperature can be measured using a thermistor, for example. In the example of using a thermistor, the thermistor can be configured to measure an in vivo or ex vivo temperature, and can be located on the analyte sensor or separate from the analyte sensor. As non-limiting examples, the thermistor can be integral with the analyte sensor, positioned on the surface of the skin of a host adjacent to an insertion site in which the analyte sensor is implanted, positioned on the skin of the host at a location away from the insertion site or spaced apart from the host entirely, such as on a handheld device carried by the host.").
As to claim 17, Bohm teaches obtaining the calibration information based on the sensitivity information ([0325], "generate calibration information (e.g., one or more of baseline, sensor sensitivity, and temperature information) that can in turn be used to form or modify a conversion function, or calibration factor, used to convert sensor data") and a difference or ratio of the subcutaneous temperature to the reference temperature ([0443], "Mean Absolute Relative Difference (MARD) of the uncompensated sensor data is 21.8%. The MARD of the compensated data is 1.8%, which is a noticeable improvement over the uncompensated data.").
As to claim 18, Bohm teaches the temperature sensor senses a temperature on the body surface and outputs the body surface temperature ([0362], "the thermistor can be integral with the analyte sensor, positioned on the surface of the skin of a host adjacent to an insertion site in which the analyte sensor is implanted"), the implanted part inserted subcutaneously senses a subcutaneous analyte concentration simultaneously and outputs a response signal ([0408], "stimulus signal output (e.g., the output of which can be indicative of the sensor's impedance) of sensor using any of the stimulus signal techniques described herein (the stimulus signal output can be obtained and processed in real time)").
As to claim 20, Bohm teaches the analyte is one or more of acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, creatinine, DNA, fructosamine, glucose, glutamine, growth hormone, hormone, ketone body, lactate, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin ([0306], "The analyte signal (e.g., glucose signal)").
As to claim 21, Bohm teaches obtaining a calibrated analyte concentration based on a relationship between the response signal of the implanted part and a change in analyte concentration at the reference temperature and a calibrated response signal ([0325], " For example, the techniques described herein can be used to generate calibration information (e.g., one or more of baseline, sensor sensitivity, and temperature information) that can in turn be used to form or modify a conversion function, or calibration factor, used to convert sensor data"; [0298], "In certain embodiments, the sensor sensitivity profile may be adjusted during sensor use to account for... patient temperature").
As to claim 22, Bohm teaches placing the implanted parts in analyte solutions of different concentrations at a reference temperature respectively;
measuring the response signals output by the implanted parts to obtain a second mapping relationship between the response signal of the implanted parts and the analyte concentration ([0278], " As illustrated in FIG. 1A, an estimative algorithm function 120 can be used to define the relationship between time during the sensor session and sensor sensitivity. The estimative algorithm function may be generated by testing a sample set (comprising one or more sensors) from a sensor lot under in vivo and/or in vitro conditions."); and
obtaining the analyte concentration based on the reference temperature, the calibrated response signal, and the second mapping relationship ([0279], “In some embodiments, a sensor may undergo an in vitro sensor sensitivity drift test, in which the sensor is exposed to changing conditions (e.g., step changes of glucose concentrations in a solution), and an in vitro sensitivity profile of the sensor is generated over a certain time period.”)
As to claim 23, Bohm teaches a maximum concentration of the analyte for inspecting the second mapping relationship is lower than a maximum sensed concentration of the implanted part (Fig. 48, uncompensated is higher than compensated).
As to claim 24, Bohm teaches a concentration gradient of the analyte used for obtaining the second mapping relationship increases progressively ([0279], “In some embodiments, a sensor may undergo an in vitro sensor sensitivity drift test, in which the sensor is exposed to changing conditions (e.g., step changes of glucose concentrations in a solution), and an in vitro sensitivity profile of the sensor is generated over a certain time period.”).
As to claim 26, Bohm teaches the second mapping relationship is a linear mapping relationship ([0268], “Because of this generally linear relationship, calibration of the sensor is obtained by solving the equation: y=mx+b”).
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Bohm as applied to claim 22 above, and further in view of US20120096918A1 (Crane et. al), hereto referred as Crane.
Claim 22 is taught as above.
As to claim 25, Bohm doesn’t necessarily teach aspects of the concentration for the second mapping Crane teaches that the concentration of the analyte used for inspection to obtain a mapping relationship is approximate to the concentration of the subcutaneous analyte (Crane, [0029], “Each calibration solution should have a different glucose concentration. The skilled person would be able to determine suitable concentrations of glucose for each solution. Typical concentrations should include zero and concentrations at the upper and lower end of those which are likely to be measured by the sensor.”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bohm in view of Crane to include concentration of the analyte used for inspection to obtain the second mapping relationship is approximate to the concentration of the subcutaneous analyte so that Bohm’s teaching about calibration is relevant to actual operating range for in vivo conditions.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Bohm as applied to claim 18 above, and further in view of US5119033A (Frick et. al), hereto referred as Frick.
Claim 18 is taught as above.
As to claim 19, Bohm doesn’t necessarily teach that there is no time delay between the output of the response signal by the implanted part and the output of the body surface temperature by the temperature sensor. Frick teaches a solution to a relevant problem of measuring temperature, and Frick teaches there is no time delay between the output of a response signal by a part and the output of a temperature by a temperature sensor (Frick, “the two converters start and complete measurement cycles at the same time. The digital representations of the pressure P and the temperature T are thereby time correlated to one another”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bohm in view of Frick to include there is no time delay between the output of the response signal by the implanted part and the output of the body surface temperature by the temperature sensor because doing so would allow correlation data analysis, as recognized by Frick.
Allowable Subject Matter
Claims 15 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As to claim 15, Bohm does not teach placing three temperature sensors having same process parameters separately and respectively in an external environment, on a surface of a phantom, and in a depth of 10 mm of the phantom subcutaneously; and changing the temperature of the external environment, and the three temperature sensors is configured to output corresponding sensed temperatures every 1 minute to obtain the first mapping relationship between the body surface temperature and the subcutaneous temperature. Claim 16 is dependent on claim 15.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELINA S JANG whose telephone number is (571)272-7019. The examiner can normally be reached M-F 9:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELINA SOHYUN JANG/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
