DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 01/25/2024. Claims 1-16 are pending and examined below.
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170188910 A1 (hereinafter referred to as “Halac”).
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Regarding claim 1, Halac, a transcutaneous analyte sensor, teaches an analyte monitoring system (abstract) comprising:
an electronics housing (104; paragraphs [0259]-[0261]; Figure 2-3) including:
a shell (120; paragraphs [0259]-[0261]; Figure 2-3) having a first aperture (as shown in annotated Figure 3) and a welding portion proximate (134 (part of the on skin portion of the sensor) can be welded; paragraph [0669]; Figure 125) the first aperture (134 is proximate the first aperture; as shown in Figure 3), the welding portion including an infrared transmissive material (sensor may be a PPG optical sensor (which uses infrared light; thus must have an infrared transmissive portion); paragraph [0685]);
a mount (122; paragraphs [0259]-[0261]; Figure 2-3) having a second aperture axially aligned with the first aperture, wherein the mount is configured to be secured to the shell to define an interior space (paragraphs [0259]-[0261]; Figure 2-3);
a collar disposed within the interior space (132; paragraphs [0280]-[0283]; as shown in Figures 7-11) and having:
a central aperture axially aligned with the first aperture and the second aperture (as shown in annotated Figure 3), and
a first collapsible rib on a first side (first portion 150 of telescoping assembly 132; paragraphs [0280]-[0283]; as shown in Figures 7-11), the first collapsible rib axially aligned with the welding portion and including an infrared absorbent material (as shown in Figure 7-11; has silicone (infrared absorbent material); paragraph [0518]; shell and cap can be made of polycarbonate; paragraph [0263]), wherein the first collapsible rib is configured to weld to the welding portion (paragraphs [0280]-[0283]; as shown in Figures 7-11);
a circuit board disposed within the interior space (electronics unit 500 can be attached to base 128; paragraph [0261]; Figure 6; 128 is disposed within the interior space; as shown in Figure 3); and
an analyte sensor having a distal portion and a proximal portion (glucose sensor 138 is part of based 128; paragraphs [0272]-[0275]; Figure 3-5), the proximal portion electrically coupled to the circuit board and the distal portion extending through the second aperture and configured to measure an analyte level in a bodily fluid of a user (electronics unit 500 can be attached to base 128; paragraph [0261]; Figure 6; Electronics unit can include a printed circuit board; paragraph [0246]).
Regarding claim 2, Halac teaches wherein the mount comprises a mount collapsible rib proximate a periphery, the mount collapsible rib comprising an infrared absorbent material and at least a periphery of the shell comprising an infrared transmissive material, wherein the mount collapsible rib is configured to weld to the periphery of the shell and secure the shell to the mount (paragraphs [0263], [0280]-[0283]; as shown in Figures 7-11).
Regarding claim 3, Halac teaches wherein the shell comprises a shell collapsible rib proximate a periphery, the shell collapsible rib comprising an infrared absorbent material and at least a periphery of the mount comprising an infrared transmissive material, wherein the shell collapsible rib is configured to weld to the periphery of the mount and secure the shell to the mount (paragraphs [0263], [0280]-[0283]; as shown in Figures 7-11).
Regarding claim 4, Halac teaches further comprising a crush rib positioned proximate a periphery of the shell and a periphery of the mount (paragraphs [0280]-[0283]; as shown in Figures 7-11).
Regarding claim 5, Halac teaches wherein the collar further comprises a second collapsible rib facing a second side of the collar facing the mount, wherein the second collapsible rib is axially aligned with the second aperture (paragraphs [0280]-[0283]; as shown in Figures 7-11).
Regarding claim 6, Halac teaches wherein the shell and the mount each comprise one of acrylonitrile butadiene styrene, cyclic olefin copolymer, nylon, polyether ether ketone, and polycarbonate (paragraphs [0263]).
Regarding claim 7, Halac teaches wherein at least one of the periphery of the shell and the periphery of the mount comprise a rib which collapses under at least one of heat and pressure in response to being subject to infrared laser welding (enough heat would collapse the rib; paragraphs [0280]-[0283]; as shown in Figures 7-11).
Regarding claim 8, Halac teaches wherein the collar comprises:
a groove which is aligned with and receives a portion of the analyte sensor (paragraphs [0280]-[0283]; as shown in Figures 7-11); and
an adhesive port extending along a longitudinal axis of the collar, aligned with the groove, and configured to receive an ultraviolet-curable adhesive to seal and secure the analyte sensor within the mount (paragraphs [0280]-[0283]; as shown in Figures 7-11).
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.
Claim(s) 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halac, in view of US 20200061613 A1 (hereinafter referred to as “Shartle”).
Regarding claim 9, Halac teaches a method for assembling an analyte monitoring system (abstract), comprising:
providing a shell having a first aperture (120; paragraphs [0259]-[0261]; Figure 2-3) and a welding portion proximate the first aperture (134 (part of the on skin portion of the sensor) can be welded; paragraph [0669]; Figure 125);
securing a mount to the shell, wherein the mount comprises a second aperture axially aligned with the first aperture, wherein securing of the mount to the shell creates an interior space (122; paragraphs [0259]-[0261]; Figure 2-3);
positioning a collar in the interior space, the collar having a central aperture axially aligned with the first aperture and the second aperture, and a first collapsible rib on a first side, the first collapsible rib axially aligned with the welding portion and including an infrared absorbent material (132; paragraphs [0280]-[0283]; as shown in Figures 7-11; has silicone (infrared absorbent material); paragraph [0518]; shell and cap can be made of polycarbonate; paragraph [0263]);
positioning a circuit board in the interior space (electronics unit 500 can be attached to base 128; paragraph [0261]; Figure 6; 128 is disposed within the interior space; as shown in Figure 3);
providing an analyte sensor having a distal portion and a proximal portion (glucose sensor 138 is part of based 128; paragraphs [0272]-[0275]; Figure 3-5), the proximal portion coupled to the circuit board and the distal portion disposed through the second aperture and configured to measure an analyte level in bodily fluid of a user (electronics unit 500 can be attached to base 128; paragraph [0261]; Figure 6; Electronics unit can include a printed circuit board; paragraph [0246]); and welding, the first collapsible rib to the welding portion (paragraph [0669]); but does not explicitly teach using an infrared laser source.
However, Shartle teaches using an infrared laser source for welding (paragraph [0005], [0008]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Halac, to use infrared laser source for welding, as taught by Shartle because making this modification merely combines prior art elements according to known methods well known in the industry (see MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)).
Regarding claim 10, Halac, in view of Shartle, teaches wherein the mount comprises a mount collapsible rib proximate a periphery, the mount collapsible rib comprising an infrared absorbent material and at least a periphery of the shell comprising an infrared transmissive material, wherein the method further comprising securing the shell to the mount by welding, using the infrared laser, the collapsible rib to the periphery of the shell (paragraphs [0280]-[0283]; as shown in Figures 7-11; as taught by Halac; paragraph [0005], [0008]; as taught by Shartle).
Regarding claim 11, Halac, in view of Shartle, teaches wherein the shell comprises a shell collapsible rib proximate a periphery, the shell collapsible rib comprising an infrared absorbent material and at least a periphery of the mount comprising an infrared transmissive material, wherein the method further comprises securing the shell to the mount by welding, using the infrared laser source, to the periphery of the mount (paragraphs [0280]-[0283]; as shown in Figures 7-11; as taught by Halac; paragraph [0005], [0008]; as taught by Shartle).
Regarding claim 12, Halac, in view of Shartle, teaches further comprising a crush rib positioned proximate a periphery of the shell and a periphery of the mount, wherein the method further comprises securing the shell to the mount by welding, using the infrared laser source, the crush rib to at least one of the shell and the mount (paragraphs [0280]-[0283]; as shown in Figures 7-11; as taught by Halac; paragraph [0005], [0008]; as taught by Shartle).
Regarding claim 13, Halac, in view of Shartle, teaches wherein the collar further comprises a second collapsible rib facing a second side of the collar facing the mount, wherein the second collapsible rib is axially aligned with the second aperture, and the method further comprises welding, using the infrared laser source, the second collapsible rib to the mount (paragraphs [0280]-[0283]; as shown in Figures 7-11; as taught by Halac; paragraph [0005], [0008]; as taught by Shartle).
Regarding claim 14, Halac, in view of Shartle, teaches wherein the shell further comprises a welding portion disposed on the shell and aligned with the first aperture, the welding portion comprising an inner weld surface is disposed thereon, and the method further comprises infrared laser welding the collar to the first weld surface (paragraphs [0280]-[0283]; as shown in Figures 7-11; as taught by Halac).
Regarding claim 15, Halac, in view of Shartle, teaches further comprising electrically connecting the analyte sensor, through the aperture, to the circuit board (electronics unit 500 can be attached to base 128; paragraph [0261]; Figure 6; Electronics unit can include a printed circuit board; paragraph [0246]; as taught by Halac).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halac, in view of Shartle, as applied to claim 9 above, and further in view of US 20190336055 A1 (hereinafter referred to as “Shah”).
Regarding claim 16, Halac, in view of Shartle, teaches the analyte sensor being secured to the collar via a port (paragraphs [0280]-[0283]; as shown in Figures 7-11); but does not explicitly teach using an ultraviolet curable adhesive.
However, Shah teaches using ultra violet curable adhesive (paragraph [0295]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Halac, in view of Shartle, to use ultraviolet curable adhesive, as taught by Shah because making this modification merely combines prior art elements according to known methods well known in the industry (see MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)).
Conclusion
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/ABID A MUSTANSIR/ Examiner, Art Unit 3791