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 (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.
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 186-188, 198, 201-202, 204-205, and 208-212 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Halac et. al.'785 (U.S. Publication Number 20190120785 – previously cited).
Regarding Claim 186, Halac et. al.’785 discloses an on-skin wearable medical device configured to be deployed to a skin of a host (Paragraph [0204] - analyte sensor system 101 implemented as a wearable device such as an on-skin sensor assembly 600) the on-skin wearable medical device comprising:
a body configured to be worn on the skin and configured to couple to a transcutaneous analyte sensor, at least a portion of the body comprising a hotmelt material (Paragraph [0217] - Sensor 138 may be permanently coupled to a component of sensor carrier 402),
the body including a base, an enclosure, and a filler disposed between the base and the enclosure (Paragraph [0217] - In some embodiments, sensor carrier 402 may be 3-D printed around sensor 138 to form pre-connected sensor 400; Paragraph [0237] - FIG. 9 shows a detailed example of a sensor module 300 including a pre-connected sensor 400 and a sealing structure 192. As shown, sealing structure 192 may be disposed on a substrate 404 - filler; Figure 9), wherein
the filler is a hot-melt material that has been injected into a cavity disposed between the base and the enclosure in a molding process (Paragraph [0217] - (e.g. substrate 404) by using, for example, adhesive (e.g… hot melt, etc.); Paragraph [0279] - In the example of FIG. 40 - actually Figure 39, substrate 404 is formed from molded thermoplastic or thermoset (e.g., acrylonitrile butadiene styrene, a liquid crystal polymer, a polyimide/polyphthalamide plastic, or other thermoplastic or thermoset polymer materials; Paragraph [0281] - Molded thermoplastic substrate 404 may be an injection-molded substrate).
Regarding Claim 187, Halac et. al.’785 discloses wherein the body comprises a housing (Paragraph [0204] - As shown in FIG. 3, on-skin sensor assembly comprises a housing 128).
Regarding Claim 188, Halac et. al.’785 discloses wherein the body is configured to retain one or more electrical components (Paragraph [0205] - The wearable sensor assembly 600 can include sensor electronics 112 operable to measure and/or analyze glucose indicators sensed by glucose sensor 138. Sensor electronics 112 – electrical component - within sensor assembly 600 can transmit information (e.g., measurements, analyte data, and glucose data) to a remotely located device).
Regarding Claim 198, Halac et. al.’785 discloses wherein the base and the enclosure are composed of a same material (Paragraph [0248] - The sealed housing – includes the base and the enclosure - may include an encapsulating material (e.g. epoxy, silicone, urethane, or other suitable material)).
Regarding Claim 201, Halac et. al.’785 discloses comprising an electrical substrate positioned between the base and the enclosure (Paragraph [0250] - Sensor carrier 402 may be configured to interface with electronics assembly substrate 530 through the bottom housing 522 - base. In other implementations, the sensor carrier 402 may be configured to interface with the electronics assembly substrate 530 through top housing 520 – enclosure; Figure 13C).
Regarding Claim 202, Halac et. al.’785 discloses a filler – hotmelt material – configured to surround the electrical substrate (Paragraph [0215] - sensor carrier 402 includes an intermediate body such as substrate 404 – hotmelt material; Paragraph [0217] - As described in further detail hereinafter, sensor carrier 402 – electrical substrate - may be attached and/or electrically coupled to sensor 138. Sensor 138 may be permanently coupled to a component of sensor carrier 402 – electronic (e.g. substrate 404) by using, for example, adhesive (e.g. UV cure, moisture cure, multi part activated, heat cure, hot melt, etc…sensor carrier 402 may be 3-D printed around sensor 138 to form pre-connected sensor 400; see Annotated Figure 9 below).
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Annotated Figure 9
Regarding Claim 204, Halac et. al.’785 discloses wherein the enclosure is configured to be coupled to the base such that a seal is formed between the base and the enclosure (Paragraph [0248] - Top housing 520 – enclosure - and bottom housing 522 – base - can be assembled together to form housing 128. Top housing 520 and bottom housing 522 can be sealed to prevent moisture ingress to an internal cavity of housing 128).
Regarding Claim 205, Halac et. al.’785 discloses wherein the hotmelt material is configured to be molded by low pressure molding (Paragraph [0303] - using a low pressure overmolding such as a moldable polyamide or a moldable polyolefin – hotmelt material, using an injection overmolded thermoplastic).
Regarding Claim 208, Halac et. al.’785 discloses comprising a patch configured to couple the body to the skin (Paragraph [0237] - An adhesive – a patch - 126 can couple the housing 128 to the skin 130 of the host).
Regarding Claim 209, Halac et. al.’785 discloses comprising the transcutaneous analyte sensor, the transcutaneous analyte sensor configured to extend from the body to be positioned within the skin (Paragraph [0215] - First internal contact 406 is electrically coupled to a first contact on a proximal end of sensor 138 – transcutaneous analyte sensor - and contact internal contact 408 is electrically coupled to a second contact on the proximal end of sensor 138. The distal end of sensor 138 is a free end configured for insertion into the skin of the host).
Regarding Claim 210, Halac et. al.’785 discloses wherein the body is configured to retain one or more electrical components for receiving a signal from the transcutaneous analyte sensor (Paragraph [0205] – entire paragraph).
Regarding Claim 211, Halac et. al.’785 discloses a filler – hotmelt material – configured to surround the electrical substrate (Paragraph [0215] - sensor carrier 402 includes an intermediate body such as substrate 404 – hotmelt material; Paragraph [0217] - As described in further detail hereinafter, sensor carrier 402 – electrical substrate - may be attached and/or electrically coupled to sensor 138. Sensor 138 may be permanently coupled to a component of sensor carrier 402 – electrical substrate (e.g. substrate 404) by using, for example, adhesive (e.g. UV cure, moisture cure, multi part activated, heat cure, hot melt, etc…sensor carrier 402 may be 3-D printed around sensor 138 to form pre-connected sensor 400 (emphasis added); see Annotated Figure 9 below).
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Annotated Figure 9
Regarding Claim 212, Halac et. al.’785 discloses an electrical substrate is disposed between the base and the enclosure when the hot-melt material is injected into the cavity (Paragraph [0217] - (e.g. substrate 404) by using, for example, adhesive (e.g… hot melt, etc.); Paragraph [0250] - Sensor carrier 402 may be configured to interface with electronics assembly substrate 530 through the bottom housing 522 - base. In other implementations, the sensor carrier 402 may be configured to interface with the electronics assembly substrate 530 through top housing 520 - enclosure; Paragraph [0279] - In the example of FIG. 40 - actually Figure 39, substrate 404 is formed from molded thermoplastic or thermoset (e.g., acrylonitrile butadiene styrene, a liquid crystal polymer, a polyimide/polyphthalamide plastic, or other thermoplastic or thermoset polymer materials; Paragraph [0281] - Molded thermoplastic substrate 404 may be an injection-molded substrate; Figure 13C).
It is noted by the examiner that Halac et. al.’785 discloses each aspect or embodiment can include any of the elements described within their application (Paragraphs [0008-0056] - independently combinable with any of the aspects or embodiments identified herein).
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.
Claims 191, 193-196, and 199 are rejected under 35 U.S.C. 103 as being unpatentable over Halac et. al.'785 (U.S. Publication Number 20190120785 – previously cited) as applied to Claim 189 above, in view of Antonio et. al.'372 (CN Patent Application 109310372 – previously cited).
Regarding Claim 191, Halac et. al.’785 discloses the medical device outlined in Claim 189 above as well as the base and the enclosure are composed of a first material (Paragraph [0248] - housing 128 is formed as a single component encapsulant (e.g. epoxy) configured to contain sensor carrier 402 and sensor electronics), wherein the hotmelt material is configured to be molded at a low pressure or temperature (Paragraph [0303] - For example, contacts 406, 408, 410, and 412 may be electrically isolated from each other and the environment, using a non-conductive adhesive such as a one or two-part epoxy, using a polyurethane, using a low pressure overmolding such as a moldable polyamide or a moldable polyolefin – hotmelt material), but fails to disclose wherein the hotmelt material is configured to be molded at a lower pressure or temperature than the first material. Antonio et. al.’372 teaches a shell – which contains a base and an enclosure - composed from a variety of materials (Page 11 Paragraph 3 to Page 12 Paragraph 1 - shell 110 be composed of a suitable rigid plastic with safety and securely holding electrical components of the sensor. As an example and not as limiting, a suitable plastic material comprising ABS, nylon, ABS/PC blends, PVC, polytetrafluoroethylene (PTFE), polypropylene, polyetheretherketone (PEEK) and polycarbonate). Nylon – a material that can be used for the base and enclosure according to Antonio et. al.’372 - is known to have a greater molding temperature and pressure than polyolefin – a material used for the hotmelt material in Halac et. al.’785. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the base and enclosure material of the medical device of Halac et. al.’785 to include more rigid materials such as Nylon as seen in Antonio et. al.’372 in order to securely hold the device’s components together as seen in Antonio et. al.’372 while keeping the hotmelt material as a low pressure molding material as seen in Halac et. al.’785.
Regarding Claim 193, Halac et. al.’785 discloses the medical device outlined in Claim 189 above as well as a hotmelt material (Paragraph [0279] - In the example of FIG. 40 - actually Figure 39, substrate 404 is formed from molded thermoplastic or thermoset (e.g., acrylonitrile butadiene styrene (ABS)), but fails to disclose the enclosure is made of a material having a greater hardness or reduced moisture permeability than the hotmelt material. Antonio et. al.’372 teaches a shell – enclosure - composed from a variety of materials that vary in level of hardness (Page 11 Paragraph 3 to Page 12 Paragraph 1 - shell 110 be composed of a suitable rigid plastic with safety and securely holding electrical components of the sensor. As an example and not as limiting, a suitable plastic material comprising ABS, nylon, ABS/PC blends, PVC, polytetrafluoroethylene (PTFE), polypropylene, polyetheretherketone (PEEK) and polycarbonate). Nylon – a material that can be used for the enclosure according to Antonio et. al.’372 - is known to have a greater hardness than ABS – a material used for the hotmelt material in Halac et. al.’785. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the enclosure material of the medical device of Halac et. al.’785 to include more rigid materials such as Nylon as seen in Antonio et. al.’372 in order to securely hold the device’s components together as seen in Antonio et. al.’372. In addition, it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the enclosure material to have a greater hardness than the hot melt material, since applicant has not disclosed that such solves any stated problem or is anything more than one of numerous shapes or configurations, a person of ordinary skill in the art would find obvious for the purpose of the base being exposed to outside environments compared to the hotmelt material that is enclosed within the shell – base and enclosure. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding Claim 194, Halac et. al.’785 discloses the medical device outlined in Claim 189 above as well as a hotmelt material (Paragraph [0279] - In the example of FIG. 40 - actually Figure 39, substrate 404 is formed from molded thermoplastic or thermoset (e.g., acrylonitrile butadiene styrene (ABS)), but fails to disclose the base is composed of a material having a greater hardness, cohesiveness, or abrasion resistance than the hotmelt material. Antonio et. al.’372 teaches a shell – includes a base - composed from a variety of materials that vary in levels of abrasion resistance (Page 11 Paragraph 3 to Page 12 Paragraph 1 - shell 110 be composed of a suitable rigid plastic with safety and securely holding electrical components of the sensor. As an example and not as limiting, a suitable plastic material comprising ABS, nylon, ABS/PC blends, PVC, polytetrafluoroethylene (PTFE), polypropylene, polyetheretherketone (PEEK) and polycarbonate). Nylon – a material that can be used for the enclosure according to Antonio et. al.’372 - is known to have a greater abrasion resistance than ABS – a material used for the hotmelt material in Halac et. al.’785. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the base material of the medical device of Halac et. al.’785 to include more rigid materials such as Nylon as seen in Antonio et. al.’372 in order to securely hold the device’s components together as seen in Antonio et. al.’372 while providing a greater abrasion resistance. In addition, it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the base material to have a greater abrasion resistance than the hot melt material, since applicant has not disclosed that such solves any stated problem or is anything more than one of numerous shapes or configurations, a person of ordinary skill in the art would find obvious for the purpose of the base being directly exposed to the environment and constant connection with a user’s skin compared to the hotmelt material that is secured and enclosed within the shell – base and enclosure. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding Claim 195, Halac et. al.’785 discloses the medical device outlined in Claim 189 above as well as a hotmelt material (Paragraph [0279] - In the example of FIG. 40 - actually Figure 39, substrate 404 is formed from molded thermoplastic or thermoset (e.g., acrylonitrile butadiene styrene (ABS)), but fails to disclose the base is composed of a material having a reduced moisture permeability than the hotmelt material. Antonio et. al.’372 teaches a shell – includes a base - composed from a variety of materials that vary in levels of moisture permeability (Page 11 Paragraph 3 to Page 12 Paragraph 1 - shell 110 be composed of a suitable rigid plastic with safety and securely holding electrical components of the sensor. As an example and not as limiting, a suitable plastic material comprising ABS, nylon, ABS/PC blends, PVC, polytetrafluoroethylene (PTFE), polypropylene, polyetheretherketone (PEEK) and polycarbonate). PVC – a material that can be used for the enclosure according to Antonio et. al.’372 - is known to have a lower moisture absorption rate than ABS – a material used for the hotmelt material. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the base material of the medical device of Halac et. al.’785 to include more rigid materials such as PVC as seen in Antonio et. al.’372 in order to securely hold the device’s components together as seen in Antonio et. al.’372. In addition, it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the base material to have a lower moisture absorption rate than the hot melt material, since applicant has not disclosed that such solves any stated problem or is anything more than one of numerous shapes or configurations, a person of ordinary skill in the art would find obvious for the purpose of keeping moisture out of the device that is housing electronic components. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding Claim 196, Halac et. al.’785 discloses the medical device outlined in Claim 189 above, but fails to disclose the enclosure and the base are molded from one or more of the materials listed within the claim’s limitation. Antonio et. al.’372 teaches a shell – which includes a base and enclosure – molded from materials listed out in the claim (Page 11 Paragraph 3 to Page 12 Paragraph 1 - shell 110 be composed of a suitable rigid plastic with safety and securely holding electrical components of the sensor. As an example and not as limiting, a suitable plastic material comprising ABS, nylon…polypropylene…polycarbonate). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the base material of the medical device of Halac et. al.’785 to include more rigid materials as seen in Antonio et. al.’372 in order to securely hold the device’s components together as seen in Antonio et. al.’372.
Regarding Claim 199, Halac et. al.’785 discloses the medical device outlined in Claim 189 above as well as a hotmelt material (Paragraph [0279] - In the example of FIG. 40 - actually Figure 39, substrate 404 is formed from molded thermoplastic or thermoset (e.g., acrylonitrile butadiene styrene (ABS)), but fails to disclose the filler is composed of a different material than the base and the enclosure. Antonio et. al.’372 teaches a shell – includes a base - composed from a variety of materials (Page 11 Paragraph 3 to Page 12 Paragraph 1 - shell 110 be composed of a suitable rigid plastic with safety and securely holding electrical components of the sensor. As an example and not as limiting, a suitable plastic material comprising ABS, nylon, ABS/PC blends, PVC, polytetrafluoroethylene (PTFE), polypropylene, polyetheretherketone (PEEK) and polycarbonate). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the material of the base and enclosure of the medical device of Halac et. al.’785 to include more rigid materials as seen in Antonio et. al.’372 in order to securely hold the device’s components together as seen in Antonio et. al.’372 while utilizing the molded thermoplastic materials as seen in Halac et. al.’785. In addition, it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the base and enclosure material to be different than the hot melt material, since applicant has not disclosed that such solves any stated problem or is anything more than one of numerous shapes or configurations, a person of ordinary skill in the art would find obvious for the purpose of the base and enclosure materials are exposed to environmental factors that the hotmelt material is not due to the hotmelt material being sealed and secured within the device. In re Dailey and Eilers, 149 USPQ 47 (1966).
Claims 197 and 200 are rejected under 35 U.S.C. 103 as being unpatentable over Halac et. al.'785 (U.S. Publication Number 20190120785 – previously cited) as applied to Claim 189 above, in view of Antonio et. al.'372 (CN Patent Application 109310372 – previously cited) as evidenced by Lee et. al.’380 (U.S. Publication Number 20160058380 – previously cited).
Regarding Claim 197, Halac et. al.’785 discloses the medical device outlined in Claim 189 above, but fails to disclose the base is composed of a different material than the enclosure. Antonio et. al.’372 teaches the material of the shell – base and enclosure - can be a variety of materials (Page 11 Paragraph 3 to Page 12 Paragraph 1 - shell 110 be composed of a suitable rigid plastic with safety and securely holding electrical components of the sensor. As an example and not as limiting, a suitable plastic material comprising ABS, nylon… polypropylene… polycarbonate; Page 7 Paragraph 4 - the shell can be made of a flexible material...(such as silicone or polyurethane)). It would have been obvious to one of ordinary skill in the art to construct a base and an enclosure out of different materials listed by Antonio et. al.’372. Doing so would be a combination of known elements in the art yielding a predictable result that does not effect the function of the device. In addition, it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the base material to be different than the enclosure material, since applicant has not disclosed that such solves any stated problem or is anything more than one of numerous shapes or configurations, a person of ordinary skill in the art would find obvious for the purpose of performing different roles in handling the device or adhering to the device’s patch that is in contact with the skin. In re Dailey and Eilers, 149 USPQ 47 (1966). Additionally, a base material being different than an enclosure material in order for the base to adhere to a device’s adhesive patch that is in contact with the skin is shown as evidence by Lee et. al.’380 (Paragraph [0155] - During this process, the electronics housing 208 is heated to a predetermined temperature, which softens the housing 208. Thereafter, the electronics housing 208 – base portion - is pressed against an adhesive pad 204 at a predetermined pressure and allowed to cool… Heat-staking is often a preferred technique for adhering the electronics housing to a component of the adhesive pad, because the technique allows for automation, which in turn allows for scaling up).
Regarding Claim 200, Halac et. al.’785 discloses the medical device outlined in Claim 189, but fails to disclose the base is composed of a first polymer, and the enclosure is composed of a second polymer that is different than the first polymer. Antonio et. al.’372 teaches the material of the shell – base and enclosure - can be a variety of materials (Page 11 Paragraph 3 to Page 12 Paragraph 1 - shell 110 be composed of a suitable rigid plastic with safety and securely holding electrical components of the sensor. As an example and not as limiting, a suitable plastic material comprising ABS, nylon… polypropylene… polycarbonate; Page 7 Paragraph 4 - the shell can be made of a flexible material...(such as silicone or polyurethane)). It would have been obvious to one of ordinary skill in the art to construct a base and an enclosure out of different materials listed by Antonio et. al.’372. Doing so would be a combination of known elements in the art yielding a predictable result that does not effect the function of the device. In addition, it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the base material to be different than the enclosure material, since applicant has not disclosed that such solves any stated problem or is anything more than one of numerous shapes or configurations, a person of ordinary skill in the art would find obvious for the purpose of performing different roles in handling the device or adhering to the device’s patch that is in contact with the skin. In re Dailey and Eilers, 149 USPQ 47 (1966). Additionally, a base material being different than an enclosure material in order for the base to adhere to a device’s adhesive patch that is in contact with the skin is shown as evidence by Lee et. al.’380 (Paragraph [0155] - During this process, the electronics housing 208 is heated to a predetermined temperature, which softens the housing 208. Thereafter, the electronics housing 208 – base portion - is pressed against an adhesive pad 204 at a predetermined pressure and allowed to cool… Heat-staking is often a preferred technique for adhering the electronics housing to a component of the adhesive pad, because the technique allows for automation, which in turn allows for scaling up).
Response to Arguments
Applicant's arguments filed 17 October 2025 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have overcome the prior claim objections.
Claims 186-188, 198, 201-202, 204-205, and 208-212 are rejected under 35 U.S.C. 102 as necessitated by amendments, as discussed in Paragraph 3 above.
Claims 191, 193-197, and 199-200 are rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraphs 4-5 above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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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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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791