DETAILED ACTION
Claims 1-20 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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/29/2024 and 04/13/2026 are being considered by the examiner.
Claim Objections
Claim 4 is objected to because of the following informalities:
Regarding claim 4, line 4 recites “the perimeter”, however it appears it should read --a perimeter-- (emphasis added).
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 5 and 13-16 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 5, line 3 recites “the perimeter”. In light of the specification, it is currently unclear if “the perimeter” is referring to “the perimeter of the aperture”, or “the perimeter” of a different claimed element. For the purposes of examination, “the perimeter” is being interpreted as being “the perimeter of the aperture”. It is recommended to the Applicant to amend the claim to read --the perimeter of the aperture-- (emphasis added).
Regarding claim 13, line 3 recites “the perimeter”. In light of the specification, it is currently unclear if “the perimeter” is referring to the perimeter of the aperture, or “the perimeter” of a different claimed element. For the purposes of examination, “the perimeter” is being interpreted as being “the perimeter of the aperture”. It is recommended to the Applicant to amend the claim to read --the perimeter of the aperture-- (emphasis added).
The dependent claims of the above rejected claim are rejected due to their dependency.
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 1-4, 6, 9, 11-14, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thomas et al. (WO 2019236850 A1) (cited in the IDS filed on 04/29/2024), hereinafter referred to as Thomas.
The claims are generally directed towards an analyte monitoring system, comprising: an enclosure including a top shell having an outer top-shell periphery and an inner top-shell periphery, and a mounting base having an outer mounting-base periphery and an inner mounting-base periphery, a circuit board disposed within the enclosure having a connector; an analyte sensor assembly having a distal portion and a proximal portion, the proximal portion coupled with the connector and the distal portion extending from the enclosure; wherein the outer top-shell periphery is ultrasonically welded to the outer mounting-base periphery; and the inner top-shell periphery is ultrasonically welded to the inner mounting-base periphery.
Regarding claim 1, Thomas discloses an analyte monitoring system (Abstract, para. [0138], Fig. 3A-3B, Fig. 5A-5B, para. [0173]), comprising:
an enclosure (Fig. 5A, element 304, para. [0173], “electronics housing”) including
a top shell having an outer top-shell periphery and an inner top-shell periphery (Fig. 5A, element 306, para. [0173-0175], “shell”, - the outer periphery being the outermost edge of 306 and the inner periphery being the innermost edge of element 306 and exposed by element 504. Further see at least Fig. 7B where elements 306 and 308 connect in the middle surrounding the sensor), and
a mounting base having an outer mounting-base periphery and an inner mounting-base periphery (Fig. 5A, element 308, para. [0173-0175], “mount”, - the outer periphery being the outermost edge of 308 and the inner periphery being the innermost edge and vertical structure extending from 308 that acts as the plug receptacle),
a circuit board disposed within the enclosure having a connector (Fig. 5A-5B, element 502, element 516, para. [0174-0176], “printed circuit board may be positioned within the electronics housing … circuitry contacts …”);
an analyte sensor assembly having a distal portion and a proximal portion, the proximal portion coupled with the connector and the distal portion extending from the enclosure (Fig. 3A, Fig. 4A-4B, element 310, para. [0166-0172], “plug assembly that may be coupled to the electronics housing … sensor module … include a sensor … electrical contacts configured to provide conductive communication between the sensor and corresponding circuitry contacts within the electronics housing …”, para. [0175] - the proximal portion being where elements 420 are located and the distal portion being where element 316 extends from the plug assembly);
wherein the outer top-shell periphery is ultrasonically welded to the outer mounting-base periphery (para. [0165], “the shell may be secured to the mount via a variety of ways … sonic welding …”, para. [0432], “sonic (or ultrasonic welding) …”); and
the inner top-shell periphery is ultrasonically welded to the inner mounting-base periphery (para. [0165], “the shell may be secured to the mount via a variety of ways … sonic welding …”, para. [0432], “sonic (or ultrasonic welding) …”).
Regarding claim 2, Thomas discloses the analyte monitoring system of claim 1, further comprising a first mating interface disposed on the top shell and a second mating interface disposed on the mounting base, the first and second mating interfaces configured to engage together to facilitate the ultrasonic welding (Fig. 7B, element 306, element 308, - the mating interfaces being the portions of elements 306 and 308 that touch on the outermost edge and the inner most edge surrounding the sensor, para. [0165], “the shell may be secured to the mount via a variety of ways … sonic welding”, para. [0432]).
Regarding claim 3, Thomas discloses the analyte monitoring system of claim 2, wherein the first mating interface is disposed along the inner top-shell periphery and the outer top-shell periphery, and the second mating interface is disposed along the inner mounting-base periphery and the outer mounting-base periphery (Fig. 7B, element 306, element 308, - the mating interfaces being the portions of elements 306 and 308 that touch on the outermost edge and the inner most edge surrounding the sensor, para. [0165], “the shell may be secured to the mount via a variety of ways … sonic welding”, para. [0432]).
Regarding claim 4, Thomas discloses the analyte monitoring system of claim 1, wherein the mounting base has an aperture (Fig. 5B, element 506, element 516, para. [0175-0176], “central apertures … plug receptacle may be defined in the bottom of mount 308 …”), the connector of the circuit board is exposed through the aperture (Fig. 5B, element 516, para. [0176], “circuitry contacts …”), and a seal is disposed around the perimeter of the aperture and between the top shell and the mounting base, the seal having a height and being configured to prevent the ingress of foreign bodies into the enclosure (para. [0165], “shell may be secured to the mount such that a sealed interface therebetween is generated … a gasket or other type of seal material may be positioned at or near the outer diameter (periphery) of the shell and the mount … compress the gasket and thereby generate a sealed interface …”).
Regarding claim 6, Thomas discloses the analyte monitoring system of claim 4, wherein the seal is disposed between the circuit board and the mounting base (para. [0165], “shell may be secured to the mount such that a sealed interface therebetween is generated … a gasket or other type of seal material may be positioned at or near the outer diameter (periphery) of the shell and the mount … compress the gasket and thereby generate a sealed interface …” - the seal is inherently between the circuit board and the mounting base to be able to compress and generate a sealed interface).
Regarding claim 9, Thomas discloses the analyte monitoring system of claim 1, wherein the circuit board comprises a processor (para. [0174], “data processing unit …”).
Regarding claim 11, Thomas discloses a method for constructing an analyte monitoring system (Abstract, para. [0138], Fig. 3A-3B, Fig. 5A-5B, para. [0173]), comprising:
assembling an enclosure (Fig. 5A, element 304, para. [0173], “electronics housing”) comprising:
a top shell having an outer top-shell periphery and an inner top-shell periphery (Fig. 5A, element 306, para. [0173-0175], “shell”, - the outer periphery being the outermost edge of 306 and the inner periphery being the innermost edge of element 306 and exposed by element 504. Further see at least Fig. 7B where elements 306 and 308 connect in the middle surrounding the sensor),
a mounting base having an outer mounting-base periphery and an inner mounting-base periphery (Fig. 5A, element 308, para. [0173-0175], “mount”, - the outer periphery being the outermost edge of 308 and the inner periphery being the innermost edge and vertical structure extending from 308 that acts as the plug receptacle), and
a circuit board disposed between the top shell and the mounting base (Fig. 5A-5B, element 502, element 516, para. [0174-0176], “printed circuit board may be positioned within the electronics housing … circuitry contacts …”); and
ultrasonically welding the outer top-shell periphery to the outer mounting-base periphery (para. [0165], “the shell may be secured to the mount via a variety of ways … sonic welding …”, para. [0432], “sonic (or ultrasonic welding) …”); and
ultrasonically welding the inner top-shell periphery to the inner mounting-base periphery (para. [0165], “the shell may be secured to the mount via a variety of ways … sonic welding …”, para. [0432], “sonic (or ultrasonic welding) …”).
Regarding claim 12, Thomas discloses the method of claim 11, wherein the top shell comprises a first mating interface, the mounting base comprises a second mating interface, and the first mating interface is engaged with the second mating interface prior to the ultrasonic welding (Fig. 7B, element 306, element 308, - the mating interfaces being the portions of elements 306 and 308 that touch on the outermost edge and the inner most edge surrounding the sensor, para. [0165], “the shell may be secured to the mount via a variety of ways … sonic welding”, para. [0432] -- the surfaces must be engaged prior to ultrasonic welding to create the secured electronics housing).
Regarding claim 13, Thomas discloses the method of claim 11, wherein the mounting base has an aperture with a perimeter (Fig. 5B, element 506, element 516, para. [0175-0176], “central apertures … plug receptacle may be defined in the bottom of mount 308 …”), the connector of the circuit board is exposed through the aperture (Fig. 5B, element 516, para. [0176], “circuitry contacts …”), a seal is disposed around the perimeter and between the top shell and the mounting base, and the top shell is mounted to the mounting base such that the seal is held in compression between the top shell and the mounting base (para. [0165], “shell may be secured to the mount such that a sealed interface therebetween is generated … a gasket or other type of seal material may be positioned at or near the outer diameter (periphery) of the shell and the mount … compress the gasket and thereby generate a sealed interface …”).
Regarding claim 14, Thomas discloses the method of claim 13, wherein the seal is further disposed between the circuit board and the mounting base (para. [0165], “shell may be secured to the mount such that a sealed interface therebetween is generated … a gasket or other type of seal material may be positioned at or near the outer diameter (periphery) of the shell and the mount … compress the gasket and thereby generate a sealed interface …” - the seal is inherently between the circuit board and the mounting base to be able to compress and generate a sealed interface).
Regarding claim 16, Thomas discloses the method of claim 13, further comprising connecting an analyte sensor assembly, through the aperture, to a connector on the circuit board (Fig. 3A, Fig. 4A-4B, element 310, para. [0166-0172], “plug assembly that may be coupled to the electronics housing … sensor module … include a sensor … electrical contacts configured to provide conductive communication between the sensor and corresponding circuitry contacts within the electronics housing …”, para. [0175]).
Regarding claim 17, Thomas discloses an enclosure for an analyte monitoring system (Abstract, para. [0138], Fig. 3A-3B, Fig. 5A-5B, element 304, para. [0173]) comprising:
a top shell having an outer top-shell periphery and an inner top-shell periphery (Fig. 5A, element 306, para. [0173-0175], “shell”, - the outer periphery being the outermost edge of 306 and the inner periphery being the innermost edge of element 306 and exposed by element 504. Further see at least Fig. 7B where elements 306 and 308 connect in the middle surrounding the sensor); and
a mounting base having an outer mounting-base periphery, and an inner mounting-base periphery (Fig. 5A, element 308, para. [0173-0175], “mount”, - the outer periphery being the outermost edge of 308 and the inner periphery being the innermost edge and vertical structure extending from 308 that acts as the plug receptacle);
wherein the outer top-shell periphery is ultrasonically welded to the outer mounting-base periphery and the inner top-shell periphery is ultrasonically welded to the inner mounting-base periphery (para. [0165], “the shell may be secured to the mount via a variety of ways … sonic welding …”, para. [0432], “sonic (or ultrasonic welding) …”).
Regarding claim 18, Thomas discloses the enclosure of claim 17, wherein the top shell comprises a first mating interface and the mounting base comprises a second mating interface such that the first mating interface is engaged with the second mating interface prior to the ultrasonic welding (Fig. 7B, element 306, element 308, - the mating interfaces being the portions of elements 306 and 308 that touch on the outermost edge and the inner most edge surrounding the sensor, para. [0165], “the shell may be secured to the mount via a variety of ways … sonic welding”, para. [0432] -- the surfaces must be engaged prior to ultrasonic welding to create the secured electronics housing).
Regarding claim 19, Thomas discloses the enclosure of claim 18, wherein the first mating interface is disposed along the inner top-shell periphery and the outer top-shell periphery, and the second mating interface is disposed along the inner mounting-base periphery and the outer mounting- base periphery (Fig. 7B, element 306, element 308, - the mating interfaces being the portions of elements 306 and 308 that touch on the outermost edge and the inner most edge surrounding the sensor, para. [0165], “the shell may be secured to the mount via a variety of ways … sonic welding”, para. [0432]).
Regarding claim 20, Thomas discloses the enclosure of claim 17, wherein the mounting base has an aperture (Fig. 5B, element 506, element 516, para. [0175-0176], “central apertures … plug receptacle may be defined in the bottom of mount 308 …”).
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.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (WO 2019236850 A1) (cited in the IDS filed on 04/29/2024), hereinafter referred to as Thomas.
Regarding claim 5, Thomas discloses the analyte monitoring system of claim 4, wherein the enclosure comprises an internal gap between the top shell and the mounting base (Fig. 7B, element 306, element 308, para. [0174], “printed circuit board … positioned within the electronics housing …”).
However, Thomas does not explicitly disclose the internal gap at the perimeter of the aperture having a height less than the height of the seal at the perimeter.
Thomas does clearly teach the variability of the dimensions and dimensional relationships of the components, which suggests that the dimensions can be optimized based on manufacturing, design, and use applications. For example, Thomas teaches the shell and the mount include different pockets or depressions to accommodate various components (para. [0505]). As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Thomas as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Regarding claim 7, Thomas discloses the analyte monitoring system of claim 6, wherein the enclosure comprises an internal gap between the circuit board and the mounting base (Fig. 7B, element 306, element 308, para. [0174], “printed circuit board … positioned within the electronics housing …”).
However, Thomas does not explicitly disclose the internal gap having a height less than a maximum height of the seal at a location of the maximum height of the seal.
Thomas does clearly teach the variability of the dimensions and dimensional relationships of the components, which suggests that the dimensions can be optimized based on manufacturing, design, and use applications. For example, Thomas teaches the shell and the mount include different pockets or depressions to accommodate various components (para. [0505]). As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Thomas as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (WO 2019236850 A1) (cited in the IDS filed on 04/29/2024), hereinafter referred to as Thomas as applied to claims 4 and 13 above, and further in view of Rao et al. (US 20170290535 A1), hereinafter referred to as Rao.
Regarding claim 8, Thomas discloses the analyte monitoring system of claim 4.
However, Thomas does not explicitly disclose wherein the mounting base further comprises a raceway around the perimeter of the aperture and at least a portion of the seal is seated in the raceway.
Rao teaches an analogous analyte monitoring system (Abstract, Fig. 9), comprising an enclosure including a top shell (Fig. 9, element 120), and a mounting base (Fig. 9, element 130), and an aperture (Fig. 6, element 132, para. [0087]). Rao further teaches a raceway is around the perimeter of the aperture and at least a portion of the seal is seated in the raceway (Fig. 9, element 340, para. [0086], para. [0090]). 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 mounting base disclosed by Thomas to additionally include a raceway around the perimeter of the aperture and at least a portion of the seal is seated in the raceway, as taught by Rao. One of ordinary skill in the art would recognize a raceway allows for the gasket to be held in place during manufacturing, ensuring a correct seal.
Regarding claim 15, Thomas discloses the method of claim 13.
However, Thomas does not explicitly disclose wherein the seal is compressed prior to the ultrasonic welding.
Rao teaches a method for constructing an analogous analyte monitoring system (Abstract, Fig. 9), comprising an enclosure including a top shell (Fig. 9, element 120), and a mounting base (Fig. 9, element 130). Rao further teaches a seal is compressed prior to the ultrasonic welding (para. [0090]). 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 method disclosed by Thomas to additionally compress the seal prior to the ultrasonic welding, as taught by Rao. This is because Rao teaches compressing the seal prior to the ultrasonic welding allows for the interior of the sensing device to be sealed from moisture, and then seal the upper housing and the lower housing to for a single device (para. [0090]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (WO 2019236850 A1) (cited in the IDS filed on 04/29/2024), hereinafter referred to as Thomas as applied to claim 1 above, and further in view of Cole et al. (US 20150018643 A1), hereinafter referred to as Cole.
Regarding claim 10, Thomas discloses the analyte monitoring system of claim 1.
However, Thomas does not explicitly disclose wherein the circuit board comprises at least one of a thermistor and thermocouple.
Cole teaches an analogous analyte monitoring system (Fig. 1, element 102, para. [0050]), comprising an enclosure including a top shell, a mounting base, and a circuit board disposed within the enclosure (Fig. 11A, para. [0112]). Cole further teaches the circuit board comprises at least one of a thermistor and thermocouple (para. [0110]). 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 circuit board disclosed by Thomas to additionally include at least one of a thermistor and thermocouple, as taught by Cole. This is because Cole teaches a thermistor or thermocouple allows for additional temperature measurements to be performed, which can be used to activate the sensor (para. [0107]).
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
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