DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/4/2026 has been entered.
Claims 26-54 remain pending and under prosecution.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim elements are interpreted under 112 sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 26-54 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brister et al (US Pub No. 20080242961) in view of Stafford (US Pub No. 20090105569 – referred to as Stafford ‘69) and Stafford (US Pub No. 20080097246 – referred to as Stafford ‘46).
It is noted that the claims are drawn to the embodiment shown in Figures 150-155. It is also noted that it is unclear which provisional date is given to said embodiment. After going through the provisional applications filed, confirmation of an earlier effective filing date was not found.
Therefore, until proven otherwise, it is submitted that the effective filing date for said embodiment of Figures 150-155 is 3/24/2011, which is the filing date of the first parent application 13/071,461 in said family, which provides the same figures of said embodiment.
In regard to Claim 26, Brister et al disclose an assembly for applying an on-body housing to a subject’s body, the assembly comprising:
an inserter 12, best seen in Figure 6, comprising:
an inserter housing 18, best seen in Figure 6 (0100);
a sharp carrier 70 coupled with a sharp 72 (0193), best seen in Figure 6;
a housing support 14 disposed at a distal end of the inserter – “the applicator comprises an applicator body 18 that guides the applicator components (see FIGS. 6 through 8) and includes an applicator body base 60 configured to mate with the mounting unit 14 during insertion of the sensor into the host. The mate between the applicator body base 60 and the mounting unit 14 can use any known mating configuration” (0100), best seen in Figure 6 and 8A; and
a glucose sensor 32, the glucose sensor comprising:
a proximal portion 40, best seen in Figure 4A (0118); and
a distal portion 42 configured to be transcutaneously positioned through a skin surface of the subject and in contact with a bodily fluid of the subject – “a distal portion 42, also referred to as the in vivo portion, adapted to extend out of the mounting unit for insertion under the host's skin,” best seen in Figure 4A (0118);
(3) a housing unit 26 containing on body electronics 28, wherein electrical contacts 28 constitute on body electronics – “the contacts 28 are mounted on or in a subassembly hereinafter referred to as a contact subassembly 26” (0105), best seen in Figure 4A,
wherein the housing unit 26 is configured to be disposed in the housing support 14 – “contacts 28 are mounted on or in a subassembly hereinafter referred to as a contact subassembly 26 (see FIG. 4A), which includes a contact holder 34 configured to fit within the base 24 of the mounting unit 14” (0105), best seen in Figure 3,
wherein the inserter is configured to advance the sharp carrier, and the sharp from a proximal position (Figure 7D) to a distal position (7B) while the housing unit remains stationary in the housing support at the distal end of the inserter (0196),
wherein the distal portion of the glucose sensor is disposed within the sharp in the proximal position, best seen in Figure 7D – “The needle can be of any appropriate size that can encompass the sensor 32” (0193),
wherein the sensor is configured to engage with the housing unit when the sensor reaches the distal position – distal portion 42 of the sensor is inserted into housing unit 26, best seen in Figure 7A-B (0197-0198) and
wherein the sharp carrier and the sharp are retracted from the distal position to a retracted position within the inserter housing, best seen in Figure 7D,
after the sharp carrier and the sharp reach the distal position, best seen in Figure 7B (0200).
However, Brister et al do not expressly disclose:
1) a sensor hub for the glucose sensor that is advanced from a proximal position to a distal position, wherein the sensor hub is configured to engage with the housing unit when the sensor hub reaches the distal position,
2) wherein, in the proximal position, the glucose sensor and the sharp are in a spaced relation with the housing unit, and
3) a retraction spring, wherein the retraction spring is configured to retract the sharp carrier and the sharp from the distal position to a retracted position within the inserter housing after the sensor hub, the sharp carrier, and the sharp reach the distal position.
1) Stafford ’69 teach that it is well-known in the art to provide an analogous glucose sensor, best seen in Figure 2C, comprising a sensor hub 202C including the circular area – engagement element (0034), a proximal portion 202A, and a distal portion 202B (0033). The sensor hub 202C enables effective engagement and positioning of the sensor as desired to minimize error after insertion – “upon final positioning of the sensor, the engagement element 202C in one embodiment is configured to engage the retainer element so that the sensor may be substantially fixedly positioned to minimize potential error or undesirable displacement” (0034).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Brister et al such that the sensor includes a sensor hub as taught by Stafford ’69 to provide a mechanism to effectively enable superior alignment without error of the sensor with the housing unit of Brister et al, as taught by Stafford ’69.
2) Stafford ’69 also teach that when in the proximal position, the glucose sensor of Figure 2C and sharp 201 are in a spaced relation with an analogous housing unit 104, best seen in Figure 2D, which includes retainer element 301, best seen in Figure 3A, 3D, and 4B –
“FIG. 3A illustrates a side cross sectional view of the plunger movement during the sensor insertion process… In particular, referring to FIG. 3A, the retainer element 301 is shown. As can be seen from the Figure, as the sensor and the introducer 201 is driven [emphasis added] through the skin layer of the patient, the engagement element 202C of the sensor contacts the retainer element 301” (0038). In other words, Stafford ‘69 explicitly states that “driving” of the sensor and the introducer results in the “the engagement element 202C of the sensor contacts the retainer element 301” (0038).
Figure 3A shows the glucose sensor of Figure 2C in a spaced relation with the retainer element 301 in the proximal position, i.e. before insertion, since the retainer element is a portion of housing unit 104, best seen in Figure 2D. Thus, Stafford ’69 teach the glucose sensor of Figure 2C and sharp 201 are in a spaced relation with the analogous housing unit 104, in the proximal, pre-insertion position, with the housing unit maintained on the skin prior to insertion of the glucose sensor, best seen in Figure 2D. This configuration effectively couples the glucose sensor to the housing unit as desired by both Stafford and Brister et al.
Additionally, it is noted that although Brister et al show the sharp 72 and glucose sensor 32 loaded into the housing unit 26 in Figure 7A prior to insertion, Brister et al also describe variability with said initial configuration – “Although FIG. 7A illustrates the needle and sensor inserted into the contacts subassembly [housing unit 26 – emphasis added] as the initial loaded configuration, alternative embodiments contemplate a step of loading the needle through the guide tube 66… prior to sensor insertion prior to sensor insertion” (0197). Thus, it appears that Brister et al do not require the sharp and glucose sensor 32 loaded into the housing unit 26 prior to insertion.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Brister et al such that wherein, in the proximal position, the glucose sensor and the sharp are in a spaced relation with the housing unit, as taught by Stafford ‘69, as an equally as effective configuration for the glucose sensor and sharp in the proximal position prior to insertion of the glucose sensor under the skin of the patient, especially since the housing unit of Stafford ‘69 is maintained on the skin prior to insertion of the glucose sensor, and also is suggested by Brister et al – housing support 14 sits on the skin prior to insertion of the glucose sensor 32, and houses the housing unit 26.
3) Additionally, Stafford ’69 teach that it is well-known in the art to provide a restriction spring to effectively retract the sharp after insertion (0029).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Brister et al to provide a retraction spring as taught by Stafford ’69 as an equally as effective retraction mechanism to retract the sharp carrier and the sharp from the distal position to a retracted position within the inserter housing of Brister et al,
wherein in combination, the addition of Stafford ’69 would predictably enable the sensor hub to be advanced from a proximal position to a distal position, wherein the sensor hub is configured to engage with the housing unit when the sensor hub reaches the distal position, and wherein the retraction spring is configured to retract the sharp carrier and the sharp from the distal position to a retracted position within the inserter housing after the sensor hub, the sharp carrier, and the sharp reach the distal position.
However, Brister et al do not expressly disclose the on body electronics include a power supply, wireless communication circuitry, and memory.
Stafford ‘46 teach that it is well-known in the art to provide an integrated on body electronics and glucose sensor 101, 106, best seen in Figure 2 (0023), wherein the on body electronics include a power supply 707, wireless communication circuitry 706, and memory necessarily within processor 704, best seen in Figure 7 (0040-0042), to effectively provide an integrated glucose sensor comprising the processing, data transmission, and power functions.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Brister et al such that the on body electronics of Brister et al include a power supply, wireless communication circuitry, and memory as taught by Stafford ’46 to effectively provide an integrated glucose sensor comprising the processing, data transmission, and power functions in addition to the glucose sensor components.
27. Brister et al in combination with Stafford disclose the assembly of claim 26, wherein the sensor hub of Stafford ‘69, the sharp carrier 70, and the sharp 72, when in the proximal position, are disposed entirely within the inserter 12, best seen in Figure 6 of Brister et al.
28. Brister et al in combination with Stafford ‘69 disclose the assembly of claim 26, wherein the housing unit 26 is disposed in the housing support 14 when the sensor hub of Stafford ‘69, the sharp carrier 70, and the sharp 72 are in the proximal position, best seen in Figure 7D of Brister et al.
29. Brister et al in combination with Stafford ‘69 disclose the assembly of claim 26, wherein the sensor hub of Stafford ‘69 is configured to engage with an aperture in the housing unit 26 of Brister et al when the sensor hub reaches the distal position, best seen in Figure 7A-D of Brister et al.
30. Brister et al disclose the assembly of claim 26, further comprising an adhesive patch 8 disposed on a distally-facing surface of the housing unit 26 through base portion 24, best seen in Figure 3 (0106).
31. Brister et al disclose the assembly of claim 30, wherein the adhesive patch 8 includes an adhesive on both sides, best seen in Figure 3 (0106-0107).
32. Brister et al disclose the assembly of claim 26, wherein the housing unit 26 is configured to be positioned in the inserter 12 prior to insertion as broadly as has been claimed, best seen in Figure 6.
33. Brister et al in combination with Stafford ‘69 disclose the assembly of claim 26, wherein the sensor hub of Stafford ‘69 is configured to be supported by the sharp carrier 70 with the sharp 72 extending distally in a surrounding position about the glucose sensor 32, best seen in Figure 2B of Stafford.
34. Brister et al disclose the assembly of claim 26, wherein the housing unit 26 is configured to be attached to the skin surface of the subject through adhesive pad 8, best seen in Figure 3 (0106-0110).
35. Stafford ’69 disclose the assembly of claim 26, wherein, in the proximal position, the glucose sensor is at least partially positioned within the sensor hub 202C, best seen in Figure 2C, and the distal portion 202B of the glucose sensor extends out of the sensor hub, best seen in Figure 2C.
36. Brister et al in combination with Stafford ’69 disclose the assembly of claim 26, wherein engagement of the housing unit 26 and the sensor hub of Stafford ’69 creates an electrical contact between the housing unit and the glucose sensor by engagement of the sensor with contacts 28 (0099).
37. Brister et al disclose the assembly of claim 36, wherein the electrical contact between the housing unit 26 and the glucose sensor 32 is configured to transfer analyte readings from the glucose sensor to the housing unit through the use of electronic unit 16 (0262-0265).
In regard to Claim 38, Brister et al disclose a method of applying an on-body housing to a subject’s body, the method comprising:
(1) advancing a glucose sensor 32, a sharp carrier 70, and a sharp 72 from a proximal position, best seen in Figure 7D within an inserter 12, best seen in Figure 6, to a distal position, best seen in Figure 7A-B (0197-0198),
to transcutaneously position a distal portion 42 of the glucose sensor through a skin surface of the subject and in contact with a bodily fluid of the subject, best seen in Figure 4A – “a distal portion 42, also referred to as the in vivo portion, adapted to extend out of the mounting unit for insertion under the host's skin,” best seen in Figure 4A (0118),
the inserter comprising:
an inserter housing 18, best seen in Figure 6 (0100);
the sharp carrier 70 coupled with the sharp 72, best seen in Figure 6 (0193); and
a housing support 14 disposed at a distal end of the inserter – “the applicator comprises an applicator body 18 that guides the applicator components (see FIGS. 6 through 8) and includes an applicator body base 60 configured to mate with the mounting unit 14 during insertion of the sensor into the host. The mate between the applicator body base 60 and the mounting unit 14 can use any known mating configuration” (0100), best seen in Figure 6 and 8A; and
the glucose sensor comprising a proximal portion 40, best seen in Figure 4A (0118) and
the distal portion 42 wherein the distal portion is disposed within the sharp in the proximal position – “The needle can be of any appropriate size that can encompass the sensor 32” (0193),
(2) engaging the sensor with a housing unit 26 when the sensor reaches the distal position – distal portion 42 of the sensor is inserted into housing unit 26, best seen in Figure 7A-B (0197-0198),
the housing unit containing on body electronics 28, wherein electrical contacts 28 constitute on body electronics – “the contacts 28 are mounted on or in a subassembly hereinafter referred to as a contact subassembly 26” (0105), best seen in Figure 4A, and
being configured to be disposed in the housing support 14 – “contacts 28 are mounted on or in a subassembly hereinafter referred to as a contact subassembly 26 (see FIG. 4A), which includes a contact holder 34 configured to fit within the base 24 of the mounting unit 14” (0105), best seen in Figure 3, and
(3) retracting the sharp carrier and the sharp from the distal position, best seen in Figure 7A-B, to a retracted position within the inserter housing, best seen in Figure 7D,
after the sensor, the sharp carrier, and the sharp reach the distal position, best seen in Figure 7B (0200),
wherein the housing unit 26 remains stationary in the housing support 14 at the distal end of the inserter during advancement of the sensor, the sharp carrier, and the sharp from the proximal position to the distal position, best seen in Figure 8A-D and 10B (0196).
However, Brister et al do not expressly disclose:
1) a sensor hub for the glucose sensor that is advanced from a proximal position to a distal position, wherein the sensor hub is configured to engage with the housing unit when the sensor hub reaches the distal position,
2) wherein, in the proximal position, the glucose sensor and the sharp are in a spaced relation with the housing unit, and
3) a retraction spring, wherein the retraction spring is configured to retract the sharp carrier and the sharp from the distal position to a retracted position within the inserter housing after the sensor hub, the sharp carrier, and the sharp reach the distal position.
1) Stafford ’69 teach that it is well-known in the art to provide an analogous glucose sensor, best seen in Figure 2C, comprising a sensor hub 202C including the circular area – engagement element (0034), a proximal portion 202A, and a distal portion 202B (0033). The sensor hub 202C enables effective engagement and positioning of the sensor as desired to minimize error after insertion – “upon final positioning of the sensor, the engagement element 202C in one embodiment is configured to engage the retainer element so that the sensor may be substantially fixedly positioned to minimize potential error or undesirable displacement” (0034).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Brister et al such that the sensor includes a sensor hub as taught by Stafford to provide a mechanism to effectively enable superior alignment without error of the sensor with the housing unit of Brister et al, as taught by Stafford ‘69.
2) Stafford ’69 also teach that when in the proximal position, the glucose sensor of Figure 2C and sharp 201 are in a spaced relation with an analogous housing unit 104, best seen in Figure 2D, which includes retainer element 301, best seen in Figure 3A, 3D, and 4B –
“FIG. 3A illustrates a side cross sectional view of the plunger movement during the sensor insertion process… In particular, referring to FIG. 3A, the retainer element 301 is shown. As can be seen from the Figure, as the sensor and the introducer 201 is driven [emphasis added] through the skin layer of the patient, the engagement element 202C of the sensor contacts the retainer element 301” (0038). In other words, Stafford ’69 explicitly states that “driving” of the sensor and the introducer results in the “the engagement element 202C of the sensor contacts the retainer element 301” (0038).
Figure 3A shows the glucose sensor of Figure 2C in a spaced relation with the retainer element 301 in the proximal position, i.e. before insertion, since the retainer element is a portion of housing unit 104, best seen in Figure 2D. Thus, Stafford ‘69 teach the glucose sensor of Figure 2C and sharp 201 are in a spaced relation with the analogous housing unit 104, in the proximal, pre-insertion position, with the housing unit maintained on the skin prior to insertion of the glucose sensor, best seen in Figure 2D. This configuration effectively couples the glucose sensor to the housing unit as desired by both Stafford and Brister et al.
Additionally, it is noted that although Brister et al show the sharp 72 and glucose sensor 32 loaded into the housing unit 26 in Figure 7A prior to insertion, Brister et al also describe variability with said initial configuration – “Although FIG. 7A illustrates the needle and sensor inserted into the contacts subassembly [housing unit 26 – emphasis added] as the initial loaded configuration, alternative embodiments contemplate a step of loading the needle through the guide tube 66… prior to sensor insertion prior to sensor insertion” (0197). Thus, it appears that Brister et al do not require the sharp and glucose sensor 32 loaded into the housing unit 26 prior to insertion.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Brister et al such that wherein, in the proximal position, the glucose sensor and the sharp are in a spaced relation with the housing unit, as taught by Stafford ‘69, as an equally as effective configuration for the glucose sensor and sharp in the proximal position prior to insertion of the glucose sensor under the skin of the patient, especially since the housing unit of Stafford ’69 is maintained on the skin prior to insertion of the glucose sensor, and also is suggested by Brister et al – housing support 14 sits on the skin prior to insertion of the glucose sensor 32, and houses the housing unit 26.
3) Additionally, Stafford ’69 teach that it is well-known in the art to provide a restriction spring to effectively retract the sharp after insertion (0029).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Brister et al to provide a retraction spring as taught by Stafford ’69 as an equally as effective retraction mechanism to retract the sharp carrier and the sharp from the distal position to a retracted position within the inserter housing of Brister et al,
wherein in combination, the addition of Stafford ’69 would predictably enable the sensor hub to be advanced from a proximal position to a distal position, wherein the sensor hub is configured to engage with the housing unit when the sensor hub reaches the distal position, and wherein the retraction spring is configured to retract the sharp carrier and the sharp from the distal position to a retracted position within the inserter housing after the sensor hub, the sharp carrier, and the sharp reach the distal position.
However, Brister et al do not expressly disclose the on body electronics include a power supply, wireless communication circuitry, and memory.
Stafford ’46 teach that it is well-known in the art to provide an integrated on body electronics and glucose sensor 101, 106, best seen in Figure 2 (0023), wherein the on body electronics include a power supply 707, wireless communication circuitry 706, and memory necessarily within processor 704, best seen in Figure 7 (0040-0042), to effectively provide an integrated glucose sensor comprising the processing, data transmission, and power functions.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Brister et al such that the on body electronics of Brister et al include a power supply, wireless communication circuitry, and memory as taught by Stafford ’46 to effectively provide an integrated glucose sensor comprising the processing, data transmission, and power functions in addition to the glucose sensor components.
39. Brister et al in combination with Stafford disclose the method of claim 38, wherein the sensor hub of Stafford ‘69, the sharp carrier 70, and the sharp 72, when in the proximal position, are disposed entirely within the inserter 12, best seen in Figure 6 of Brister et al.
40. Brister et al in combination with Stafford ’69 disclose the method of claim 38, wherein the housing unit 26 is disposed in the housing support 14 when the sensor hub of Stafford ‘69, the sharp carrier 70, and the sharp 72 are in the proximal position, best seen in Figure 7D of Brister et al.
41. Brister et al in combination with Stafford ’69 disclose the method of claim 38, further comprising engaging the sensor hub of Stafford ‘69 with an aperture in the housing unit 26 of Brister et al when the sensor hub reaches the distal position, best seen in Figure 7A-D of Brister et al.
42. Brister et al disclose the method of claim 38, wherein the housing unit 26 comprises an adhesive patch 8 disposed on a distally-facing surface of the housing unit through base portion 24, best seen in Figure 3 (0106).
43. Brister et al disclose the method of claim 42, wherein the adhesive patch 8 includes an adhesive on both sides, best seen in Figure 3 (0106-0107).
44. Brister et al disclose the method of claim 38, further comprising positioning the housing unit 26 in the inserter 12 prior to insertion as broadly as has been claimed, best seen in Figure 6.
45. Brister et al in combination with Stafford ’69 disclose the method of claim 38, further comprising supporting the sensor hub of Stafford ’69 by the sharp carrier 70 with the sharp 72 extending distally in a surrounding position about the glucose sensor 32, best seen in Figure 2B of Stafford ‘69.
46. Brister et al disclose the method of claim 38, further comprising attaching the housing unit 26 to the skin surface of the subject through adhesive pad 8, best seen in Figure 3 (0106-0110).
47. Stafford ‘69 disclose the method of claim 38, wherein, in the proximal position, the glucose sensor is at least partially positioned within the sensor hub 202C, best seen in Figure 2C, and the distal portion 202B of the glucose sensor extends out of the sensor hub, best seen in Figure 2C.
48. Brister et al in combination with Stafford ’69 disclose the method of claim 38, further comprising creating an electrical contact between the housing unit 26 and the glucose sensor 32 by engagement of the housing unit and the sensor hub of Stafford ‘69 by engagement of the sensor with contacts 28 in Brister et al (0099).
49. Brister et al in combination with Stafford ‘69 disclose the assembly of claim 26, wherein the sensor hub of Stafford ‘69 and the housing unit 26 are not in contact with each other when the sensor hub, the sharp carrier 70, and the sharp 72 are in the proximal position, best seen in Figure 7D of Brister et al when modified by Stafford ’69.
50. Brister et al in combination with Stafford ’69 disclose the method of claim 38, wherein the sensor hub of Stafford ’69 and the housing unit 26 are not in contact with each other when the sensor hub of Stafford ‘69, the sharp carrier 70, and the sharp 72 are in the proximal position, best seen in Figure 7D of Brister et al when modified by Stafford ’69.
51. Brister et al in combination with Stafford ‘69 disclose the assembly of claim 26, wherein a distal tip of the sharp 72 is proximal to a proximal surface of the housing unit 26 when the sensor hub of Stafford ‘69, the sharp carrier 70 and the sharp 72 are in the proximal position, best seen in Figure 7D of Brister et al when modified by Stafford ’69.
52. Brister et al in combination with Stafford ’69 disclose the method of claim 38, wherein a distal tip of the sharp 72 is proximal to a proximal surface of the housing unit 26 when the sensor hub of Stafford ‘69, the sharp carrier 70 and the sharp 72 are in the proximal position, best seen in Figure 7D of Brister et al when modified by Stafford ’69.
53. Brister et al in combination with Stafford ’69 disclose the assembly of claim 30, wherein the adhesive patch 8 is disposed on the distally-facing surface of the housing unit 26 through while the sensor hub of Stafford ‘69, the sharp carrier 70, and the sharp 72 are in the proximal position, best seen in Figure 7D of Brister et al.
54. Brister et al in combination with Stafford ’69 disclose the method of claim 42, wherein the adhesive patch 8 is disposed on the distally-facing surface of the housing unit 26 while the sensor hub of Stafford ‘69, the sharp carrier 70, and the sharp 72 are in the proximal position, best seen in Figure 7D of Brister et al.
Response to Arguments
Applicant’s arguments with respect to claim(s) above have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Stafford (US Pub No. 20080097246) have been set forth to teach an integrated on body electronics and glucose sensor 101, 106, best seen in Figure 2 (0023), wherein the on body electronics include a power supply 707, wireless communication circuitry 706, and memory necessarily within processor 704, best seen in Figure 7 (0040-0042), to effectively provide an integrated glucose sensor comprising the processing, data transmission, and power functions.
Additionally, it is submitted that Stafford ’69 also teach that when in the proximal position, the glucose sensor of Figure 2C and sharp 201 are in a spaced relation with an analogous housing unit 104, best seen in Figure 2D, which includes retainer element 301, best seen in Figure 3A, 3D, and 4B –
“FIG. 3A illustrates a side cross sectional view of the plunger movement during the sensor insertion process… In particular, referring to FIG. 3A, the retainer element 301 is shown. As can be seen from the Figure, as the sensor and the introducer 201 is driven [emphasis added] through the skin layer of the patient, the engagement element 202C of the sensor contacts the retainer element 301” (0038). In other words, Stafford ‘69 explicitly states that “driving” of the sensor and the introducer results in the “the engagement element 202C of the sensor contacts the retainer element 301” (0038).
Figure 3A shows the glucose sensor of Figure 2C in a spaced relation with the retainer element 301 in the proximal position, i.e. before insertion, since the retainer element is a portion of housing unit 104, best seen in Figure 2D. Thus, Stafford ’69 teach the glucose sensor of Figure 2C and sharp 201 are in a spaced relation with the analogous housing unit 104, in the proximal, pre-insertion position, with the housing unit maintained on the skin prior to insertion of the glucose sensor, best seen in Figure 2D. This configuration effectively couples the glucose sensor to the housing unit as desired by both Stafford and Brister et al.
Additionally, it is noted that although Brister et al show the sharp 72 and glucose sensor 32 loaded into the housing unit 26 in Figure 7A prior to insertion, Brister et al also describe variability with said initial configuration – “Although FIG. 7A illustrates the needle and sensor inserted into the contacts subassembly [housing unit 26 – emphasis added] as the initial loaded configuration, alternative embodiments contemplate a step of loading the needle through the guide tube 66… prior to sensor insertion prior to sensor insertion” (0197). Thus, it appears that Brister et al do not require the sharp and glucose sensor 32 loaded into the housing unit 26 prior to insertion, despite the embodiment shown in Figure 7A and pointed out by applicant (Remarks pg. 11).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Brister et al such that wherein, in the proximal position, the glucose sensor and the sharp are in a spaced relation with the housing unit, as taught by Stafford ‘69, as an equally as effective configuration for the glucose sensor and sharp in the proximal position prior to insertion of the glucose sensor under the skin of the patient, especially since the housing unit of Stafford ‘69 is maintained on the skin prior to insertion of the glucose sensor, and also is suggested by Brister et al – housing support 14 sits on the skin prior to insertion of the glucose sensor 32, and houses the housing unit 26. Thus, the use of Brister et al in this regard is maintained as modified by Stafford ’69.
Conclusion
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791