DETAILED ACTION
Claims 60-64 are hereby under examination.
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 .
Claim Objections
Claim 63 is objected to because of the following informalities:
Regarding claim 63, line 7 recites “the integrated sensing unit”, however it appears it should--the integrated sensing and data acquisition unit-- (emphasis added) to maintain consistent claim language.
Claim Interpretation - 35 USC § 112(f)
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:
Claim 60: The claim limitation “a communication and power unit … which powers and transmits data representative of said analyte concentrations” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “which powers and transmits data representative of said analyte concentrations” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
Claim 63: The claim limitation “an integrated communication and power unit … which powers the integrated sensing and data acquisition unit and transmits data representative of said analyte concentrations” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “which powers the integrated sensing and data acquisition unit and transmits data representative of said analyte concentrations” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“The communication unit 140 further comprises a receiver subsystem (RX) 1401, a transmitter subsystem (TX) 1402, and a MUX/DEMUX network 1403 to separate the communication signal for the power signal” and “The power management unit 120 can include a regulator (e.g., low V-LDO regulator), reference generator, power detector, temperature sensor, and control logic”, or equivalents thereof, as described on pg. 18 and pg. 20 of the disclosure filed on 10/03/2023; and
“The communication unit 140 further comprises a receiver subsystem (RX) 1401, a transmitter subsystem (TX) 1402, and a MUX/DEMUX network 1403 to separate the communication signal for the power signal” and “The power management unit 120 can include a regulator (e.g., low V-LDO regulator), reference generator, power detector, temperature sensor, and control logic”, or equivalents thereof, as described on pg. 18 and pg. 20 of the disclosure filed on 10/03/2023.
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.
Claims 60-62 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 60, lines 3-4 recite “each working electrode paired with different respective potentiostats”. However, lines 4-5 further recite “a communication and power unit connected to the potentiostat”. In light of the specification, it is currently unclear if 1) a single communication and power unit is connected to only one potentiostat, 2) a single communication and power unit is connected to the different respective potentiostats, or 3) each different respective potentiostat is connected to a different respective communication and power unit. For the purposes of examination, “a communication and power unit connected to the potentiostat” is being interpreted as “a communication and power unit connected to the potentiostats”. It is recommended to the Applicant to amend the claims to clearly recite what “the potentiostat” encompasses.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 62, line 1 recites “a potentiostat”. However, claim 60 recites “each working electrode paired with different respective potentiostats”. In light of the specification, it is currently unclear if “a potentiostat” is the same as, related to, or different from “different respective potentiostats”. For the purposes of examination, “a potentiostat” is being interpreted as being the same as the “different respective potentiostat”, recited in claim 60. It is recommended to the Applicant to amend 62 to clearly recite what “a potentiostat” and “at least one working electrode” are referring to in relation with claim 60.
Claim Rejections - 35 USC § 102
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 60-62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nazari et al. (US 20200178801 A1), hereinafter referred to as Nazari.
The claims are generally directed towards a monolithically integrated sensor chip configured for insertion into a patient comprising: at least two working electrodes for sensing two or more analytes and generating signals representative of analyte concentration, each working electrode paired with different respective potentiostats at independent working potentials, and a communication and power unit connected to the potentiostat, which powers and transmits data representative of said analyte concentrations.
Regarding claim 60, Nazari discloses a monolithically integrated sensor chip configured for insertion into a patient (Abstract, Fig. 1, Fig. 2, Fig. 4A, para. [0008], para. [0011], para. [0014]) comprising:
at least two working electrodes for sensing two or more analytes and generating signals representative of analyte concentration (Fig. 2, element 160, para. [0034], “an integrated sensing element … consist of 3 electrodes … a working electrode …”, para. [0056], “integrated sensing element in response detects the analyte of interest based upon its surface chemistry …”, para. [0057], “sensor can include … one or more sensing elements”, para. [0059], “one or more sensors that can detect and measure the presence of one or more analyte of interest in tissue fluid …”, para. [0079], “one or more sensors … quantities and qualities of various parameters of interest can be determined as a function of these one or more data signals …”, para. [0112], “several working electrodes for sensing different analytes”, para. [0135], “sensing element can be functionalized to be sensitive and specific … enzyme that reacts with glucose … another working electrode without an enzyme coating can be used for background (e.g. oxygen) measurements …”), each working electrode paired with different respective potentiostats at independent working potentials (para. [0056], “sends DC power to the potentiostat which powers up the integrated sensing element …”, para. [0075], “potentiostat can be connected to the sensing element …”, para. [0114], “in order to support multi-analyte sensing … each individual sensing element can be controlled by a dedicated potentiostat …”), and
a communication and power unit connected to the potentiostat, which powers and transmits data representative of said analyte concentrations (Fig. 2, Fig. 4A, element 120, , element 130, element 140, element 150, para. [0023], “power management unit, a signal acquisition and processing unit, a signal receiver unit, a signal transmitter unit …”, para. [0065-0074], para. [0077], “wirelessly communication with the external transceiver”, para. [0078], “output by the power management unit into the various circuits of the other functional modules …”, para. [0098], “supply provides power to the analog circuitry that includes potentiostats …”, para. [0215]).
Regarding claim 61, Nazari discloses the monolithically integrated sensor chip of claim 60, wherein the independent working potentials are different working potentials (para. [0080], “controls the operation of the integrated sensing element at a given potential different”, para. [0112], “independently controlling the potential different … in a multi-analyte sensor where there are several working electrodes for sensing different analytes”, para. [0131], “detection at different potentials”).
Regarding claim 62, Nazari discloses the monolithically integrated sensor chip of claim 60, wherein a potentiostat is connected within half a millimeter to the entirety of at least one working electrode (para. [0059], para. [0118] - the dimensions of the sensor and the interconnected functional modules being as small as 30 microns x 50 microns x 200 microns allows for the at least one working electrode to be connected to a respective potentiostat within half a millimeter).
Claim Rejections - 35 USC § 103
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.
Claims 63-64 are rejected under 35 U.S.C. 103 as being unpatentable over Nazari et al. (US 20200178801 A1), hereinafter referred to as Nazari, in view of Scherer et al. (US 20170020416 A1), hereinafter referred to as Scherer.
Regarding claim 63, Nazari discloses a monolithically integrated sensor chip configured for insertion into a patient (Abstract, Fig. 1, Fig. 2, Fig. 4A, para. [0008], para. [0011], para. [0014]) comprising:
an integrated sensing and data acquisition unit for sensing two or more analytes and generating signals representative of analyte concentration, said integrated sensing and data acquisition unit having at least two working electrodes (Fig. 2, element 160, para. [0034], “an integrated sensing element … consist of 3 electrodes … a working electrode …”, para. [0056], “integrated sensing element in response detects the analyte of interest based upon its surface chemistry …”, para. [0057], “sensor can include … one or more sensing elements”, para. [0059], “one or more sensors that can detect and measure the presence of one or more analyte of interest in tissue fluid …”, para. [0079], “one or more sensors … quantities and qualities of various parameters of interest can be determined as a function of these one or more data signals …”, para. [0112], “several working electrodes for sensing different analytes”, para. [0135], “sensing element can be functionalized to be sensitive and specific … enzyme that reacts with glucose … another working electrode without an enzyme coating can be used for background (e.g. oxygen) measurements …”), a first working electrode configured to work via a potentiostat (para. [0056], para. [0075], para. [0110], “electrochemical sensing elements using amperometric measurement at a given potential, a potentiostat can be designed and implemented to perform the function …”); and
an integrated communication and power unit connected to the integrated sensing unit, which powers the integrated sensing and data acquisition unit and transmits data representative of said analyte concentrations (Fig. 2, Fig. 4A, element 120, , element 130, element 140, element 150, para. [0023], “power management unit, a signal acquisition and processing unit, a signal receiver unit, a signal transmitter unit …”, para. [0065-0074], para. [0077], “wirelessly communication with the external transceiver”, para. [0078], “output by the power management unit into the various circuits of the other functional modules …”, para. [0098], “supply provides power to the analog circuitry that includes potentiostats …”, para. [0215]).
However, Nazari does not explicitly disclose a second working electrode configured to work via voltammetry.
Scherer teaches of an analogous monolithically integrated sensor chip configured for insertion into a patient (Abstract, Fig. 13, para. [0050], para. [0054]). Scherer teaches the integrated sensor chip comprises an integrated sensing and data acquisition unit having at least two working electrodes, including a second working electrode configured to work via voltammetry (para. [0054], “four or more electrode design can also be used where more than one working electrodes can be used to measure differential signals for better noise immunity or multiple species at a time …”, para. [0060-0061], para. [0094], para. [0110], “potentiostat can be employed in different electrochemical modes … potentiostat can work in both amperometric and cyclic voltammetry regime …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the integrated sensing and data acquisition unit disclosed by Nazari to explicitly include a second working electrode configured to work via voltammetry, as taught by Scherer. This is because Scherer teaches working via a potentiostat and via voltammetry supports a wide range of voltage difference between the working and reference electrodes, while covering a large current range as well, which produces more reliable results (para. [0110]).
Regarding claim 64, modified Nazari discloses the monolithically integrated sensor chip of claim 63, wherein the potentiostat is connected within half a millimeter to the entirety of the first working electrode (para. [0059], para. [0118] - the dimensions of the sensor and the interconnected functional modules being as small as 30 microns x 50 microns x 200 microns allows for the at least one working electrode to be connected to a respective potentiostat within half a millimeter).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791