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 .
Amendment Entered
In response to the amendment filed on 12/31/2025, amended claims 136 and 146 are entered. Claims 136-155 remain pending.
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 136, 146, and all claims dependent thereon, 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.
Claims 136 and 146 recite, inter alia, “…a socket coupled to the body and including an opening on the outer top surface of the body and being configured to couple to a plug coupled to a transcutaneous analyte sensor…” in lines 5-6 and 6-7 respectively. It is unclear which recited structure applicant intends to include an opening on the outer surface of the body (i.e., does the socket include an opening on the outer top surface of the body? Or, does the body include an opening on the outer top surface?). Furthermore, it is unclear which recited structure applicant intends to couple to a plug (i.e., is the socket intended to couple to the plug? Or is the body intended to couple to the plug?). This renders the scope of the claim unclear, as there is ambiguity regarding how applicant intends to integrate the recited structures. For examination purposes, claims 136 and 146 will be examined as if a socket includes an opening on the outer top surface of the body, and the socket is configured to couple to a plug.
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.
Claims 136-145 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0030325 A1 to Huang et al. (“Huang”) in view of US 2006/0229512 A1 to Petisce et al. (“Petisce”).
Regarding claim 136: Huang teaches an on-skin wearable medical device configured to be deployed to a skin of a host (see Figs. 2-4 and [0050], “...physiological signal monitoring device includes a base 1, a biosensor 2, and a transmitter 3…”) the on-skin wearable medical device comprising:
a body configured to be worn on the skin and including an outer bottom surface for facing towards the skin and an outer top surface for facing away from the skin; (see Figs. 2-4 and [0054], “...base 1 is permitted to be attached to the skin surface of the host via an adhesive pad 16…mounted to the bottom surface 116 of the bottom plate 111… ,see also [0061]-[0062], “…transmitter 3 is removably mounted (e.g., removably covered) to the base body 11 of the base 1… includes a bottom casing 31… casing 31 includes a bottom surface 311, a top surface 312, a first groove 313…”, base body 11 of base 1 (i.e., body) has bottom plate 111(i.e., outer bottom surface) facing towards the skin of a user, and casing 31 (i.e., outer top surface) facing away from the skin); and
a socket coupled to the body and including an opening on the outer top surface of the body (see Figs. 2, 11 and [0061]-[0062], “…transmitter 3 is removably mounted…to the base body 11… includes a bottom casing 31 facing the top surface 115 of the bottom plate 111 of the base body 11…first groove 313 is defined by a groove surrounding surface 315…and a groove bottom surface 316…when the transmitter 3 covers to the base 1…first groove 313 receives the inner groove wall 114 of the base body 11…”, see also [0065], “…connection port 36…protrudes downwardly in the direction of the first axis (D1) into the first groove 313 of the bottom casing 31, and includes a socket 367 …”, first groove 313 (i.e., socket) is mounted to base body 11 (i.e., coupled to the body) and includes socket 367 (i.e., opening) on casing 31 (i.e., on outer top surface of housing));
and being configured to couple to a plug coupled to a transcutaneous analyte sensor (see Figs. 2, 5, 9, 11 and [0093] “…base body 11, the biosensor 2, and the transmitter 3 fittingly engage with one another...connection port 36 is retained in the mounting space 210 of the mounting seat 21 when the signal output section 221 of the sensing member 22 is inserted into the connection port 36; the mounting seat 21 is mounted in the inner groove wall 114 (i.e., in the mounting groove 113) both of which are mounted in the first groove 313…”, see also [0055], “…biosensor 2 includes amounting seat 21 that is mounted to the mounting groove 113 of the base body 11, and a sensing member 22 that is carried and limited by the mounting seat 21 and that is adapted for measuring the at least one analytical substance of the host…”, first groove 313 (i.e., socket) couples to mounting seat 21 (i.e., plug), which includes sensing member 22 (i.e., transcutaneous analyte sensor))
the socket including a raised portion and a channel surrounding the raised portion, the raised portion including one or more electrical contacts for electrical connection with the transcutaneous analyte sensor (see Fig. 11 and [0062], “…a first groove 313…defined by a groove surrounding surface 315…and a groove bottom surface 316 that is connected to the groove surrounding surface 315…”. see also Figs. 2, 5, 6 and [0065], “...connection port 36… protrudes…into the first groove 313…includes a socket 367 that is for the signal output section 221…sensing member 22 is electrically connected to the circuit board 33 via a plurality of conducting members 364 disposed in the connection port 36…”, groove 313 (i.e., socket) includes connection port 36 (i.e., raised portion) which is surrounded by bottom surface 316 and surrounding surface 315 (i.e., channel). Connection port 36 (i.e., raised portion) includes conducting members 364 (i.e., electrical contacts) allowing electrical connection with sensing member 22 (i.e., analyte sensor)),
the channel including a fluid disposed therein in contact with at least a portion of the plug (see Figs. 2, 4, and [0085]-[0086], “…airtight space 100 is formed between the first groove 313 of the bottom casing 31 of the transmitter 3 and the bottom plate 111 of the base 1, the top surface 212 of the mounting seat 21…”, bottom surface 316 and surrounding surface 315 of first groove 313 (i.e., channel of socket) and surface 212 of mounting seat 21 (i.e., plug) form airtight space 100 (an airtight space indicating presence of air (i.e., fluid) disposed in the space formed by surfaces 315 and 316 of groove 313 (i.e., channel of socket)).
However, Huang fails to disclose “a socket coupled to the body…”.
Although Huang fails to explicitly disclose a socket coupled to a body of an on-skin wearable medical device, Huang teaches a socket coupled to a transmitter (see Figs. 2-5 and [0062], “...the transmitter 3 covers to the base 1, the bottom surface 311 abuts against the bottom plate 111 of the base body 11, the first groove 313 receives the inner groove wall 114 of the base body 11 and the biosensor 2 therein…”) where the transmitter is removably connected to a base body (see Figs. 2-5 and [0061], “...transmitter 3 is removably mounted…to the base body 11 of the base 1 and connected to the biosensor 2…”).
Therefore, 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 modify Huang (to couple a socket to a body) for the purpose of reducing the overall thickness of the device, as evidence by Huang (see [0062]). Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to couple a socket to the body of an on-skin wearable medical device, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Additionally, Huang fails to explicitly disclose “…the channel including a fluid disposed therein for forming a seal with at least a portion of the plug”.
Petisce teaches a transcutaneous analyte measurement sensor system (see Figs. 12A-12C and [0330], “…transcutaneous analyte sensor system 10 measures a concentration of an analyte… electronics unit 16 is connected to the mounting unit 14, the sensor 32 is able to measure levels of the analyte in the host”) including a channel filled with a fluid for forming a seal between system components (see [0334]-[0335], “…sealant fills in holes, crevices, or other void spaces between the mounting unit 14 and electronics unit 16 and/or around the sensor 32 within the mounting unit 32… sealant comprises a water impermeable material or compound, for example, oil, grease, or gel…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the fluid of Huang (to form a deal with at least a portion of the plug) for the purpose of protecting system components from exposure to moisture, as evidence by Petisce (see [0333]). Furthermore, one of ordinary skill in the art would have had predictable success combining Huang and Petisce since both teachings relate to the same narrow field of endeavor, i.e., utilizing analyte measurements to estimate various types of bio-information.
Regarding claims 137 and 138: The Huang/Petisce combination teaches the on-skin wearable medical device of claim 136, as discussed above. The Huang/Petisce combination further teaches wherein the fluid comprises a gel and wherein the gel comprises petroleum jelly (see Petisce [0355], “… sealant comprises a water impermeable material or compound, for example…gel…the sealant comprises petroleum jelly”).
Regarding claim 139: The Huang/Petisce combination teaches the on-skin wearable medical device of claim 136, as described above. Huang further teaches a reservoir for receiving and storing any excess amount of the fluid following the coupling of the plug to the socket (see Figs. 4, 5 and [0085], “…desiccant 5 that is mounted anywhere in an airtight space 100…cooperatively defined by the base 1 and the transmitter 3 when the base 1 and the transmitter 3 are coupled to each other, so that the biosensor 2 is remained to be in low humidity to ensure proper measurement”, desiccant 5 (i.e., reservoir) reduces humidity (i.e., receives and stores excess humidity in airgap 100 (i.e., excess fluid)) after coupling of groove 313 (of transmitter 3) and mounting seat 21 (of base 1)).
However, Huang fails to explicitly disclose “wherein the channel includes a reservoir for receiving and storing any excess amount of the fluid following the coupling of the plug to the socket”.
In an alternate embodiment, Huang teaches a channel including a reservoir for receiving and storing any excess amount of fluid (see Figs. 4, 5 and [0086], “…the groove bottom surface 316 of the transmitter 3 is formed with two humidity grooves (not shown) for storing the desiccants 5 therein…”, bottom surface 316 (i.e., of channel) stores desiccant 5 (i.e., reservoir)).
Therefore, 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 modify the Huang/Petisce combination (to include a reservoir in a channel) for the purpose of ensuring proper measurements of the analyte sensor, as evidence by Huang (see [0085]). Furthermore, such modification would have been obvious to one having ordinary skill in the art at the time the invention was made, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 140: The Huang/Petisce combination teaches the on-skin wearable medical device of claim 136, as discussed above. Huang further teaches a raised outer wall surrounding the channel (see Fig. 11 and [0062], “…groove surrounding surface 315 that is connected to the bottom surface 311…”, surface 315 (i.e., raised outer wall) surrounds channel).
Regarding claim 141: The Huang/Petisce combination teaches the on-skin wearable medical device of claim 140/136, as discussed above. Huang further teaches wherein the raised outer wall contours to a shape of the plug (see Figs. 2, 5, 9 and [0093], “…mounting seat 21 is mounted in the inner groove wall 114 (i.e., in the mounting groove 113), both of which are mounted in the first groove 313 of the transmitter 3…”, surface 315 (i.e., raised outer wall) of groove 313 mounts mounting seat 21 (i.e., plug), receipt of mounting seat 21 by surface 315 of groove 313 for mounting indicating contouring shapes of plug and outer wall).
Regarding claim 142: The Huang/Petisce combination teaches the on-skin wearable medical device of claim 136, as discussed above. Huang further teaches wherein the raised portion includes a coupler for coupling with the plug (see Figs. 2, 5, and 6 and [0065], “...connection port 36…includes a socket 367 that is for the signal output section 221 of the sensing member 22 to be inserted thereinto to permit electric connection between the sensing member 22 and the circuit board 33”, connection port 36 (i.e., raised portion) includes socket 367 (i.e., coupler) for coupling to sensing member 222 (i.e., of plug 21)).
Regarding claim 143: The Huang/Petisce combination teaches the on-skin wearable medical device of claim 136, as discussed above. Huang further teaches wherein the raised portion is configured to enter a cavity of the plug (see Figs. 2, 9, and [0093], “…connection port 36 is retained in the mounting space 210 of the mounting seat 21 when the signal output section 221 of the sensing member 22 is inserted into the connection port 36…”, connection port 36 (i.e., raised portion) is retained in mounting space 210 of mounting seat 21 (i.e., cavity of plug)).
Regarding claim 144: The Huang/Petisce combination teaches the on-skin wearable medical device of claim 136, as discussed above. Huang further teaches wherein the raised portion includes a top surface that the one or more electrical contacts are positioned on, the top surface configured to face the plug, and the socket includes a bottom surface facing opposite the top surface, the one or more electrical contacts passing from the top surface to the bottom surface (see Figs. 5, 6, and [0065], “…connection port 36 is connected to a bottom surface of the circuit board 33, protrudes downwardly in the direction of the first axis (D1) into the first groove 313…includes a socket 367 that is for the signal output section 221 of the sensing member 22 to be inserted thereinto … member 22 is electrically connected to the circuit board 33 via a plurality of conducting members 364…respectively abut along a radial direction thereof against a plurality of electrical contacts 331a…abut along the radial direction thereof against several outputs of electrodes 226…on the signal output section 221 of the sensing member 22”, see also Figs. 4, 11 and [0062], “…first groove 313 is defined by…a groove bottom surface 316 that is connected to the groove surrounding surface 315…” conducting members 364 (i.e., electrical contacts) are positioned on connection port 36 (i.e., raised portion) at a bottom surface of circuit board 33 (i.e., a top surface of raised portion), which protrudes in the D1 direction for contact with sensing member 22 of mounting seat 21 (i.e., faces the plug). Groove 313 (i.e., socket) includes bottom surface 316 (i.e., bottom surface) which faces bottom surface of circuit board 33 (i.e., top surface of raised portion). Conducting members 364 extend from contacts 331a (on top surface of raised portion) toward bottom surface 316 of groove 313 (i.e., electrical contacts pass from the top surface to the bottom surface)).
Regarding claim 145: The Huang/Petisce combination teaches the on-skin wearable medical device of claim 144/136, as discussed above. Huang further teaches wherein the one or more electrical contacts comprise an electrically conductive material (see Fig. 5 and [0065], “…sensing member 22 is electrically connected to the circuit board 33 via a plurality of conducting members 364…”).
However, the Huang/Petisce combination fails to disclose “…wherein the one or more electrical contacts comprise an electrically conductive elastomeric material”.
Huang further discloses elasticity of the electrical contacts (see Fig. 6 and [0065], “…members 364 are helical springs…”, helical spring indicates elasticity of members 364), and further teaches a member made of an elastic and metallic material (see Fig. 2 and [0056], “…hooking member 14 is a plate made of an elastic material, which can also be metallic…”) that when compressed, deformably engages with a plug coupled to an analyte sensor (see Figs. 2, 5, and [0056], “When the biosensor 2 is pressed toward the base 1 via an external force, the two hooked ends of the hooking member 14 initially and respectively abut against the mounting seat 21 so as to be deformed and to generate restoring force”).
Although Huang fails to explicitly disclose that conducting members 364 (i.e., electrical contacts) comprise an elastomeric material, Huang discloses elastic electrical contacts (see [0065], and further teaches an elastic and metallic member, deforming to engage a plug and an analyte sensor when compressed (see [0065]). Therefore, 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 modify the electrical contacts of Huang (to comprise an electrically conductive elastomeric material) for the purpose of improving the stability of the analyte sensor, as evidence by Huang (see [0065]). Furthermore, such modification would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 146-149 and 153-155 are rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of US 2018/0313810 A1 to Galasso.
Regarding claim 146: Huang teaches an on-skin wearable medical device configured to be deployed to a skin of a host (see Figs. 2-4, 29-30 and [0050], “...physiological signal monitoring device includes a base 1, a biosensor 2, and a transmitter 3…”), the on-skin wearable medical device comprising:
an elongate housing configured to be worn on the skin and having a long dimension (see Figs. 2-5 and [0051], “...base 1 includes a base body 11 that has a bottom plate 111 adapted to be mounted to the skin surface of the host…”, see also [0094], “…overall thickness of the physiological signal monitoring device is 4.9 mm, the overall width, length and thickness of the base body 11 are respectively 23.0 mm, 36.0 mm, and 3.5 mm…”, base body 11 mounts base 1 (i.e., elongate housing) to the skin of a user, and has a length greater than that of the width and height (i.e., a long dimension))
and including an outer bottom surface for facing towards the skin and an outer top surface for facing away from the skin (see Figs. 2-4 and [0051], “...base 1 includes a base body 11 that has a bottom plate 111 adapted to be mounted to the skin surface of the host…”, see also [0061]-[0062], “…transmitter 3 is removably mounted (e.g., removably covered) to the base body 11 of the base 1… includes a bottom casing 31… casing 31 includes a bottom surface 311, a top surface 312, a first groove 313…”, base body 11 of base 1 (i.e., elongate housing) has bottom plate 111 (i.e., outer bottom surface) facing towards the skin of a user, and casing 31 (i.e., outer top surface) facing away from the skin of a user); and
a socket coupled to the elongate housing and including an opening on the outer top surface of the elongate housing (see Figs. 2, 11 and [0061]-[0062], “…transmitter 3 is removably mounted…to the base body 11… includes a bottom casing 31 facing the top surface 115 of the bottom plate 111 of the base body 11…first groove 313 is defined by a groove surrounding surface 315…and a groove bottom surface 316…when the transmitter 3 covers to the base 1…first groove 313 receives the inner groove wall 114 of the base body 11…”, see also [0065], “…connection port 36…protrudes downwardly in the direction of the first axis (D1) into the first groove 313 of the bottom casing 31, and includes a socket 367 …”, first groove 313 (i.e., socket) is mounted to base body 11 (i.e., coupled to the elongate housing) and includes socket 367 (i.e., opening) on casing 31 (i.e., on the outer top surface of elongate body));
and being configured to couple to a plug coupled to a transcutaneous analyte sensor (see Figs. 2, 5, 9, 11 and [0093] “…base body 11, the biosensor 2, and the transmitter 3 fittingly engage with one another...connection port 36 is retained in the mounting space 210 of the mounting seat 21 when the signal output section 221 of the sensing member 22 is inserted into the connection port 36; the mounting seat 21 is mounted in the inner groove wall 114 (i.e., in the mounting groove 113) both of which are mounted in the first groove 313…”, see also [0055], “…biosensor 2 includes amounting seat 21 that is mounted to the mounting groove 113 of the base body 11, and a sensing member 22 that is carried and limited by the mounting seat 21 and that is adapted for measuring the at least one analytical substance of the host…”, first groove 313 (i.e., socket) couples to mounting seat 21 (i.e., plug), which includes sensing member 22 (i.e., transcutaneous analyte sensor)).
However, Huang fails to disclose “an elongate socket coupled to the elongate housing and including an opening on the outer top surface of the elongate housing and being configured to couple to a plug coupled to a transcutaneous analyte sensor…”.
Galasso teaches sensor ports compatible with transcutaneous analyte monitoring systems (see [0043], “…sensor ports may be integrated with a continuous analyte monitoring system…include a component that receives analyte data from a transcutaneously positioned or wholly implanted glucose sensor…”) including a housing (see figs. 1A-1C and [0051], “a sensor port 100, which includes a housing 101, wherein the housing 101 includes a body 102…”) having an elongated member that receives an analyte sensor (see Figs. 1A-1C and [0051], “…protruding member 103 which protrudes from body 102…defines an entry slot 104 which is configured to receive an analyte sensor…defining an elliptical shape around the outside edge of protruding member 103…configurations are possible for the protruding member 103…e.g., circular, oval, or polygonal configurations”).
Therefore, 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 modify the socket of Huang (to be elongated) for the purpose of conforming to the shape of the sensor received by the device, as evidence by Galasso (see [0053]). Additionally, such modification would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, since it has been held that a change in configuration of shape of a device is obvious, absent persuasive evidence that a particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Furthermore, one of ordinary skill in the art would have had predictable success combining Huang and Galasso, since their teachings relate to the same narrow field of endeavor, i.e., structures of analyte sensors for determining various types of bio-information.
Additionally, Huang fails to disclose “an elongate socket coupled to the elongate housing including an opening on the outer top surface of the elongate housing and being and configured to couple to a plug coupled to a transcutaneous analyte sensor…”.
Although Huang fails to explicitly disclose a socket coupled to a body of an on-skin wearable medical device, Huang teaches a socket coupled to a transmitter (see Figs. 2-5 and [0062], “...the transmitter 3 covers to the base 1, the bottom surface 311 abuts against the bottom plate 111 of the base body 11, the first groove 313 receives the inner groove wall 114 of the base body 11 and the biosensor 2 therein…”) where the transmitter is removably connected to a base body (see Figs. 2-5 and [0061], “...transmitter 3 is removably mounted…to the base body 11 of the base 1 and connected to the biosensor 2…”).
Therefore, 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 modify Huang (to couple a socket to a body) for the purpose of reducing the overall thickness of the device, as evidence by Huang (see [0062]). Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to couple a socket to the body of an on-skin wearable medical device, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Additionally, Huang fails to disclose “…the elongate socket having a long dimension extending along the long dimension of the elongate housing”.
The Huang/Galasso combination further teaches an elongate socket having a long dimension (see Galasso Figs. 1A-1C and [0051], “…protruding member 103 which protrudes from body 102…defines an entry slot 104 which is configured to receive an analyte sensor…defining an elliptical shape around the outside edge of protruding member 103…”).
Therefore, 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 further modify the elongate socket of the Huang/Galasso combination (to extend along the long dimension of the elongate housing) for the purpose of reducing the overall volume of the device, as evidence by Huang (see [0093]).
Regarding claim 147: The Huang/Galasso combination teaches the on-skin wearable medical device of claim 146, as discussed above. The Huang/Galasso combination further teaches wherein the elongate socket (of the Huang/Galasso combination) comprises an upper level positioned above a lower level of the elongate housing (see Huang Figs. 5, 10, 11, and [0062], “…first groove 313 is defined by a groove surrounding surface 315 that is connected to the bottom surface 311 and a groove bottom surface 316 that is connected to the groove surrounding surface 315…transmitter 3 covers to the base 1, the bottom surface 311 abuts against the bottom plate 111 of the base body 11, the first groove 313 receives the inner groove wall 114 of the base body 11 and the biosensor 2 therein”, groove 313 (i.e., elongated socket of Huang/Galasso combination) comprises groove surface 316 (i.e., an upper level) positioned above bottom plate 111 of base body 11 (i.e., a lower level of elongate housing)).
Regarding claim 148: The Huang/Galasso combination teaches the on-skin wearable medical device of claim 147/146, as discussed above. The Huang/Galasso combination further teaches one or more electrical components comprising one or more of a transmitter or a battery (see Huang Figs. 2, 5, 10 and [0061], “…transmitter 3 includes…a battery 35 that is disposed in the inner space 30 and that is electrically connected to the circuit board 33…”, see also [0063], “…circuit board 33 includes a signal transmission module…signal transmission module is well known in the art and may be internally rearranged to fit different needs…signal transmission module may include a combination of a signal amplifier, an analog-digital signal converter, a processor, and a transmitter…”, electrical components, battery 35 (i.e., battery) and transmission module (i.e., transmitter) positioned in transmitter 3).
However, the Huang/Galasso combination fails to disclose “wherein the lower level includes one or more electrical components comprising one or more of a transmitter or a battery”.
The Huang/Galasso combination teaches electrical components including a transmitter and a battery (see Huang [0061]), but teaches they are positioned in a transmitter located above a lower level of an elongate housing (see Huang Figs. 2, 5, and [0061]). Therefore, 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 modify the Huang/Galasso combination (to position the electrical components (i.e., battery, transmitter) in a lower level of an elongate housing) for the purpose of providing a more compact device by reducing the reducing the thickness of the device, as evidence by Huang (see [0064]). Furthermore, such modification would have been obvious to one having ordinary skill in the art at the time the invention was made, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 149: The Huang/Galasso combination teaches the on-skin wearable medical device of claim 146, as discussed above. The Huang/Galasso combination further teaches wherein the elongate socket (of the Huang/Galasso combination) is positioned above a transmitter (see Huang Figs. 2, 5, and [0061], “…transmitter 3 includes…connection port 36 that is connected to a bottom surface of the circuit board 33 and that extends outwardly from the inner space 30 toward the base body 11…” see also Huang [0062], “…first groove 313 that indents from the bottom surface 311…”, see also Huang [0063], “…circuit board 33 includes a signal transmission module… may include a combination of a signal amplifier, an analog-digital signal converter, a processor, and a transmitter”, transmitter is located in circuit board 33, which is positioned below groove 313 (i.e., socket of the Huang/Galasso combination)).
Regarding claim 153: The Huang/Galasso combination teaches the on-skin wearable medical device of claim 146, as discussed above. The Huang/Galasso combination further teaches wherein the elongate housing is flexible (see Huang [0103], “…base body 11 of the base 1 is flexible…”).
Regarding claim 154: The Huang/Galasso combination teaches the on-skin wearable medical device of claim 146, as discussed above. The Huang/Galasso combination further teaches wherein the elongate housing includes a bottom portion configured to be positioned proximate the skin and a top portion configured to be raised above the bottom portion, wherein the bottom portion includes a film layer (see Huang Figs. 2, 3, and [0054], “…base 1 is permitted to be attached to the skin surface of the host via an adhesive pad 16. The adhesive pad 16 is mounted to the bottom surface 116 of the bottom plate 111… adhesive pad 16 is made of nonwoven fabrics and is applied with adhesives on both sides thereof, one side being attached to the bottom surface 116 of the bottom plate 111 and the other side being attached to the skin surface of the host…”, base 1 (i.e., housing) includes adhesive pad 16 (i.e., bottom portion) positioned on the skin of a user, having adhesive layers (i.e., film layers), and bottom plate 111 (i.e., top portion) positioned above pad 16).
Regarding claim 155: The Huang/Galasso combination teaches the on-skin wearable medical device of claim 154/146, as discussed above. The Huang/Galasso combination further teaches a patch coupled to the bottom portion, the patch configured to couple the elongate housing to the skin (see Huang Figs. 2, 3, and [0054], “…base 1 is permitted to be attached to the skin surface of the host via an adhesive pad 16. The adhesive pad 16 is mounted to the bottom surface 116 of the bottom plate 111…”, adhesive pad 16 (i.e., patch) mounted to bottom plate 111 (i.e., bottom portion) couples base 1 (i.e., elongate housing) to skin of a user).
Claims 150-152 are rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Galasso, and further in view of US 2020/0337608 A1 to Garai et al. (“Garai”).
Regarding claim 150: The Huang/Galasso combination teaches the on-skin wearable medical device of claim 146, as discussed above. The Huang/Galasso combination further teaches wherein the elongate housing comprises a molded material, and molding using multiple materials (see Huang [0105], “…base body 11 is made of one of polymer material (such as plastics, rubbers or silica gels), metallic material and a mixture of polymer material and metallic material… thickness (t1) is able to be 0.05 mm at minimum if the base body 11 is injection molded with a metallic material, and the thickness (t1) is able to be 0.3 mm at minimum if the base body 11 is injection molded with a plastic material…”). The Huang/Galasso combination further teaches injection molding multiple structures of the elongate base as a single piece (see Huang [0108], “…base body 11 and the first coupling structures 12 are injection molded as a single piece…”).
However, the Huang Galasso combination fails to explicitly disclose “…wherein the elongate housing comprises a co-molded material”.
Garai teaches a flexible glucose sensor coupling to a user (see [0001], “…a flexible physiological characteristic sensor assembly for coupling to a user…physiological characteristic sensor is a glucose sensor”) with an elongated, flexible, molded, lower housing (see Fig. 2 and [0127], “…lower housing 16 is substantially planar, and is flexible… lower housing 16 may be molded...”), coupled to an elongate, flexible, molded, top housing (see Fig. 2 and [0105], “…top housing 12 is flexible, and in one example is composed of a biocompatible polymer… a polyphenyl ether, thermoplastic polyurethane, silicone, etc.…may be molded…”), which is co-molded (see [0106], “…needle port 28 is composed of a biocompatible polymer…acrylonitrile butadiene styrene (ABS), polypropylene, etc.…port 28 is formed through molding…port 28 is co-molded with the top housing 12…”).
Therefore, 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 modify the elongate housing of the Huang/Galasso combination (to comprise a co-molded material) for the purpose of aligning the elongated housing during assembly, as evidence by Garai (see [0107]). Furthermore, one of ordinary skill in the art would have had predictable success combining Huang/Galasso and Garai, since their teachings both/all relate to the same narrow field of endeavor, i.e., structural features of analyte sensors for determining various types of bio-information.
Regarding claim 151: The Huang/Galasso/Garai combination teaches the on-skin wearable medical device of claim 150/146, as discussed above. The Huang/Galasso/Garai combination further teaches wherein the co-molded material (of the Huang/Galasso/Garai combination) includes a first material having a greater stiffness than a second material (see Garai Fig. 2 and [0105], “…top housing 12…is composed of a biocompatible polymer… a polyphenyl ether, thermoplastic polyurethane, silicone, etc.…”), see also Garai [0106], “…needle port 28 is composed of a biocompatible polymer…acrylonitrile butadiene styrene (ABS), polypropylene, etc. …port 28 is co-molded with the top housing 12…”, needle port 28 molded using ABS, (i.e., first material) has a greater stiffness than top housing 12 (i.e., second material) molded using silicone). Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07.
Regarding claim 152: The Huang/Galasso/Garai combination teaches the on-skin wearable medical device of claim 151/150/146, as discussed above. The Huang/Galasso/Garai combination further teaches wherein the first material comprises a frame that the second material is coupled to, and the second material forms at least a portion of an outer surface of the elongate housing (see Garai [0105], “…top housing 12 is opposite the lower housing 16…forms a portion of an outermost surface of the physiological characteristic sensor assembly 10 …housing 12 includes…a needle port 28 coupled to the top housing 12 to extend through the top housing 12 from the first side 24 to the second side 26”, …”, needle port 28 (i.e., first material of the Huang/Galasso/Garai combination) extends through top housing 12 (i.e., second material of the Huang/Galasso/Garai combination) (i.e., needle port 28 acts as a frame for top housing 12 to couple to) and top housing 12 forms a portion of the outer surface of the housing (i.e., the elongate housing of the Huang/Galasso/Garai combination)).
Response to Arguments
Applicant's arguments filed 12/31/2025 with respect to the rejection of claims 136-155 under 35 U.S.C. 103 have been fully considered but they are moot in view of the current combination of references that were necessitated by amendment.
In particular, on page 5 of the remarks, Applicant argues that Huang and Petisce, taken individually or in combination, fail to teach or suggest independent claim 136 as amended. This argument is considered not persuasive in view of the treatment of claim 136 above.
Additionally, on page 5 of the remarks, Applicant argues that Huang, Galasso, and Garai taken individually or in combination, fail to teach or suggest independent claim 146 as amended. This argument is considered not persuasive in view of the treatment of claim 146 above.
Therefore, claims 136-155 remain rejected under 35 U.S.C. 103.
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.
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/ALYSSA PAIGE NOVAK/Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791